chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to her husband a 62 year old male patient with no medical history or drug reactions. The patient was vaccinated with ZOSTAVAX (lot number not reported) at some time after 11-JUN-2012. No other co-suspects were reported. There was no concomitant medications. In 2012 the patient experienced tingling and pain in his mouth at an unspecified time after receiving after receiving ZOSTAVAX. The patient went to an unspecified dentist, who found no dental problems. The patient was treated with ibuprofen. On an unspecified date, the patient was recovered. This is one of the several reports received from the same source. Additional information has been requested.
second day post vaccine woke w/102.2/ fever fever broke by day 3; first day after vaccine developed chills and the worst headache of my life along w/fatigue; first day after vaccine developed chills and the worst headache of my life along w/fatigue; first day after vaccine developed chills and the worst headache of my life along w/fatigue; This is a spontaneous report from a contactable healthcare professional (patient). A 58-year-old female patient received first single dose of BNT162B2 (Pfizer, lot number: ett9899, exp date not reported), via an unspecified route of administration (vaccine location: Left arm) on 30Dec2020 11:00 for COVID-19 immunization. The vaccine was administered in a hospital. Medical history included osteoarthritis bilateral knees. The patient was not pregnant. Concomitant medication include amoxicillin, clavulanate potassium (AUGMENTIN), ascorbic acid (VITAMIN C ACID), meloxicam, and calcium carbonate (CAL). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and there were no other medications within two weeks. On 31Dec2020 22:00, the first day after vaccine, patient developed chills and the worst headache of her life along with fatigue. On 01Jan2021, second day post vaccine, she woke with 102.2 fever; chills were gone, headache mild, fatigue present. The fever broke by day 3 (02Jan2021). No treatment was provided for the events. The events were considered as non-serious by the reporter. Patient did not have covid prior vaccination. Patient was not tested for covid post vaccination. The patient recovered from the fever on 02Jan2021, chills recovered on 31Dec2020, while outcome of headache and fatigue was unknown.
Vision in right eye became very very blurry, not matter what I did.  woke up the next day not being able to see anything in that eye, except blurry lights.  The day I received the vaccine my feet developed pins needles and numbness with pain and it comes and goes.  It spreads to my hands and arms.   I have been very itchy as well, covered in hives.
I had Covid-19 within a week of my first dose in May of 2021. Two days after the vaccine I woke up with chest pain. I was sweating and I felt really tired. I had an uncomfortable feeling in my chest. On 6/25/2021 I went to the ER at Hospital and I was diagnosed with Myocarditis. My Troponin level was 109. I was admitted to the hospital for three days. I was transported to another Hospital.  I was still having chest pain when I was discharged, and I still had some chest discomfort and exhausted. By 06/02/2021 I felt better. I was advised to consult a cardiologist within the next couple of months.
Patient developed left leg pain and swelling a few days after receiving her second Pfizer COVID19 vaccination.  She was seen in the ER and found to have extensive iliofemoral DVT of the left leg.  She was taken for a venogram and thrombectomy and then started on Eliquis.
Pt developed frequent inconsolable crying on day of vax, fever started 2-3 days later & marked irritability & fever resulted  in septic w/u being done 11DEC90;
inadvertently administered the DTap-IPV portion and not the hib portion, no AE; Initial information received on 20-Nov-2020 regarding an unsolicited valid non-serious case from a physician.  This case involves a 4 months old patient who was inadvertently administered the dtap-ipv portion and not the hib portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (2 dose, 0.5 ml, lot number and expiration date not reported) via unknown route in unknown administration for prophylactic vaccination on 19-Nov-2020 (product preparation issue).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.   No concomitant medication were given to patient.  It was a case of actual medication error due to inappropriate reconstitution technique (same day latency).  At the time of report no adverse event was reported.  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.  There will be no information on the batch number for this case.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), in May2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 60 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Pancreatic cancer undergoing chemo therapy" (unspecified if ongoing); "Pancreatic cancer undergoing chemo therapy" (unspecified if ongoing). Concomitant medication(s) included: ELIQUIS. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2022) positive, notes: Positive Antigen test at home 5 days after completing complete course of Paxlovid. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications and drug reactions or allergies was provided. On 14-AUG-2018, the patient was vaccinated with an improperly stored dose of Oka/Merck VARIVAX subcutaneously, lot # R011808 expiration date of 23-APR-2020, for prophylaxis (strength was not reported) that was reconstituted with properly stored MERCK STERILE DILUENT lot # M033585 with expiration date of 21-APR-2019. No adverse effects were reported. It was stated that the vaccines underwent a temperature excursion 15°F to 46°F (degrees Fahrenheit) for 5 days. No previous temperature excursion was performed. The call was not because of a "data logger".
Patient received the VARIVAX on 7/16/2018. Found out she was pregnant at the end of July after her visit.
I experienced in July 2022, I had fever, fatigue, mild cold symptoms. I took Paxlovid on the second day of my symptoms. My symptoms went away in 24 hours.  When I stopped my Paxlovid medicine my symptoms returned. My antigen test became negative after 18 days of onset. Three days after my rebound I recovered.  Within one day of symptoms, I was positive, one day before I was negative.
Pain, swelling, and tenderness at the injection site. Mother instructed to administer Ibuprofen and use warm compresses and to return call if symptoms do not improve or worsen.
She had hives all the way up and down her arms, that were painful and very hot.; She had hives all the way up and down her arms, that were painful and very hot.; She had hives all the way up and down her arms, that were painful and very hot.; This spontaneous report has been received from an approximately  64 year old female patient with high blood pressure, high cholesterol, severe depression and anxiety. The patient's drug reactions included hyperaction to an unspecified medication. Concomitant therapies included "Affixer", rosuvastatin calcium(CRESTOR) and lisinopril(manufacturer unknown).      On an unspecified day in 2008, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) injection (route, lot number and anatomical location were not reported) for prophylaxis (indication reported as "Doctor wanted her to get the vaccine").        On an unspecified day in 2008, she had a serious reaction to the vaccine for about 3-4 weeks. She had hives all the way up and down her arms, that were painful and very hot. The patient seek for medical attention; however, no treatment was given.  On an unknown date, 4 weeks after getting the vaccine, the patient recovered from the events.  The patient considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23).
pt recv vax 10AUG98 & 23AUG98 knot appeared & got red & sore;mom states it looks like a spider bite;
Symptoms started  01/01/2021 at 14:30 - Body aches, chills, and very sore arm at the site of injections.  01/02/2021 at 01:30- Woke up with an elevated temp of 100.0 F, body aches, chills, sore left arm, and general fatigue 01/02/2021 at 10:30- Normal temp again, but still experiencing body aches, chills, sore left arm, general fatigue, and general lack of appetite.  01/02/2021 at 18:30- starting to feel slightly better, regained appetite. Normal temp. Still experiencing body aches and fatigue.  01/03/2021 at 08:00- woke up feeling better. The only lasting side effect is a sore and swollen arm at the site of injections
1630: Participant presented after getting stuck twice by vaccinator and questioned if she received two doses of the vaccine. Per the vaccinators, this participant was the sixth and final dose of the vial. Vaccinator initially went to administer the dose and noted that there was nothing in the syringe when he went to push the plunger.   After reviewing the vial with the pharmacy staff, there is still vaccine in the vial with enough volume for a possible seventh dose. With this information I discussed with the participant that participant did not receive two doses. Participant started crying and developing chest pain which prompted an evaluation by EMS team in house at the vaccination center. Due to chest pain, she was given nitroglycerin x 1, and sent to local hospital via ambulance for further evaluation.  We received report from hospital that participant had an MI and was sent to catheterization lab.
Patient noticed a red bump approximately 4" in diameter the morning after receiving her vaccination.  She reported pain, swelling, heat, and itching at the site. She denied any fever, chills, or systemic effects other than general fatigue she thought might be attributed to the vaccine. She came to the pharmacy approximately 72 hours after receiving the vaccination. She said the injection/reaction site had not gotten better or worse since the morning after her shot. There was a small red streak coming from the site, but she said it had reduced in color since the morning. I advised her to monitor for signs of infection/worsening of the site and to contact her doctor the next morning to be seen and evaluated.  I called her about 24 hours after she came to us. She reported that the red area was shrinking and she was feeling a "little better."
patient received the incorrect pfizer vaccine for the patients age. Due to the language barrier when asking patient if that was the correct DOB they just said yes. The store where they received their first wrong at another store was due to incorrect DOB too.
(R) Deltoid presents hematoma that goes down to the elbow. 3cc/22Gx1 1/2 vanishpoint syringe used. PT CONCERNED ABOUT HIS ARM. HE CAME BACK TODAY TO THE CLINIC. REPORTS IT IS GETTING BETTER. SEEN BY A NP WHO INDICATED TO REPORT THE ADVERSE REACTION TO CDC.
Client obtained her first dose COVID vaccine (Janssen COVID vaccine on 05/16/2021 lot: 20621A). Client reported that she no chronic medical conditions, currently not taking any medications and has no known allergies. Client is requesting to obtained a Pfizer Booster COVID vaccine. Client did report that 10 minutes after her Janssen COVID vaccine that she felt dizzy, hot, sweating in both arms and neck and that it lasted for 5 minutes. No other reactions reported. RN submitted a medical consult via text to Vaccine Operation Lead and approval from Dr. was obtained for client to receive Pfizer Booster COVID vaccine. RN educated client to have client stay 30 minutes after her Pfizer Booster COVID vaccine and educated on ER precautions and when to follow up her Primary Care Provider. Client's mother verbalized understanding. Client received Pfizer Booster COVID vaccine lot: FL3189. Client completed 30 minutes observation and no adverse reaction reported. Client left facility at 6:14PM.
ADMINISTRATION ERROR : Pt. states that 1st dose of Moderna given 08/30/2021 and 2nd dose 09/22/2021 (Blurry Vision)
On the afternoon of the day of vaccination, patient vomited several times and felt "lethargic." By early evening, pt had chills and tactile fever. Motrin was given. Complained of shortness of breath intermittently. No lip/tongue swelling noted.
discomfort in arm pit; swollen; hard lump; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (discomfort in arm pit), PERIPHERAL SWELLING (swollen) and SWELLING (hard lump) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21a) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced LIMB DISCOMFORT (discomfort in arm pit), PERIPHERAL SWELLING (swollen) and SWELLING (hard lump). At the time of the report, LIMB DISCOMFORT (discomfort in arm pit), PERIPHERAL SWELLING (swollen) and SWELLING (hard lump) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications reported.  No treatment information was provided.
This spontaneous report received from a patient concerned a 58 year old white male. The patient's height and weight were not reported. The patient's concurrent conditions included: pre diabetic, hepatitis c (positive but not active genotype 3), chronic pain syndrome, arthritis, bipolar, anxiety disorder, smoker (nicotine) and allergy. The patient was previously received Moderna covid-19 vaccine (elasomeran) (dose number in series 1) (form of administration, route of administration were not reported, batch number: 012H21PZ and expiry: unknown) dose was not reported, administered to the right arm on 01-SEP-2021 for covid-19 prophylaxis. It was unknown whether the patient had any adverse events following vaccination with Moderna covid-19 vaccine (elasomeran) (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: 1808980 expiry: unknown) dose was not reported, 1 total administered to the right arm on 01-OCT-2021 for covid-19 prophylaxis which was an off label dosing frequency. The drug was associated with Off label use. Age at time of vaccination 58 years old. Concomitant medications included lisinopril (drug started on OCT-2021), metformin (drug started MAY-2022), omeprazole (drug started on JAN-2022) and sildenafil (drug started on AUG-2022). The patient also received non-company co-suspect drug Pfizer (Paxlovid) (form of administration, route of administration, batch number, and expiry were not reported) dose was not reported, administered on 17-AUG-2022 for treatment of COVID-19. On 18-AUG-2022, the patient experienced fogged mental state, ears popping, anxiety and tingling in the skin (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable and with Pfizer (Paxlovid) was unknown. The patient recovered from fogged mental state, ears popping, anxiety, and tingling in the skin on 19-AUG-2022, and the outcome of off label dosing frequency was not reported. This report was non-serious.
Pediatric patient came for her second dose and given an adult dose. Patient showed no reaction to the dosage. She was contacted after going home and no issues noted. Advised to follow-up with her pediatrician and monitor.
pt recv vax; pt felt badly; tests revealed elev liver enzymes of LDH 406, SGOT 211, & SGPT 305;
Pt states that after receiving the vaccine that he had a horrible bout of constipation that required norco to be able to get through the pain associated with it. He also states that he has had very bad headaches since getting the vaccination and that he had a bad rash on his leg. Pt states he was seen by the office and they recommended he reach out to us as he also believes we gave him a higher dose than he was suppose to receive.
The day I received the vaccine, 8 hour post inhection, I began to have numbness in both hands and it went up my arm on the injection site arm. Almost 24 hours after getting vaccine, I woke up the following morning around 4am to body aches, chills, low grade fever, nausea, numbness in both hands, neck stiffness, and excruciating pain in the arm I received the vaccine in ( unable to lift arm). I began taking Tylenol, every 4 hours and zofran for nausea. The symptoms proceeded to get worse. At 3pm the same day I decided to go to the urgent care. I was febrile 101.2, tachycardia, hypertensive, I was tested for the flu- results came back negative.
This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 21K-163-4104075-00. A 64 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administration date Jan2021 (Batch/Lot number: unknown) at the age of 64 years as dose 1, single and intramuscular, administration date 13Feb2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) at unk (citrate free) for rheumatoid arthritis. Relevant medical history included: "Pneumonia", start date: 1969 (unspecified if ongoing); "Pneumonia", start date: 2002 (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant), outcome "unknown", described as "Pneumonia four times"; BRONCHITIS (non-serious), outcome "recovered", BRONCHITIS (non-serious), outcome "not recovered" and all described as "Bronchitis". The patient underwent the following laboratory tests and procedures: respiratory rate decreased: unknown results. The action taken for adalimumab was unknown. Therapeutic measures were taken as a result of pneumonia, bronchitis, bronchitis.  Clinical information: It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient was treated with HYCODAN.  The reporter considered "pneumonia four times" and "bronchitis" related to bnt162b2.  The reporter's causality for the event(s) of BRONCHITIS unknown onset and BRONCHITIS unknown onset with HUMIRA(ADALIMUMAB) was no reasonable possibility. The reporter's causality for the event(s) of PNEUMONIA FOUR TIMES was not provided.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event "pneumonia four times" and "bronchitis" and the suspect vaccine 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.
Vax admin 10/13/14 at 11:44 AM. Patient's daughter 10/25/14 notified the pharmacy that her father already received the vaccine on 9/23/14. Pt's daughter is upset. Sx: Lethargic, no energy, doesn't feel well.
Developed shingles 10 days post-vaccination; This is a spontaneous report from contactable consumer reported for herself. A 45-year-old non-pregnant female patient received first dose of bnt162b2 (Pfizer COVID-19 vaccine, Solution for injection, Batch/lot number: FD8448), via an unspecified route in the right arm on 20Aug2021 (age at vaccination: 45-year-old), as a single dose for COVID-19 immunization. The patient medical history was reported as none. Concomitant medications included Vitamin D3 and ascorbic acid (VITAMIN C). No known drug allergies were reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 30Aug2021, patient developed shingles 10 days post-vaccination. Adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures taken as a result of the events included unknown medications. The clinical outcome of the event was recovering/ resolving.   Follow-up attempts are needed. No further information is expected.
no additional AE'S; mproperly Stored; Administered; This spontaneous report was received from a licensed practical nurse referring to a patient of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 18-MAR-2021 the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1687290, expiration date was reported as 02-SEP-2022, but upon internal validation established as 06-SEP-2022; dose and route were not reported) for prophylaxis, the vaccine was temperature excursion (product storage error). No additional AE reported.   The administered dose of the vaccine experienced a temperature excursion of 28.34 Fahrenheit (F) for 1 hour and 2 minutes. There was previous temperature excursion (30.28F for 19 minutes; 34.81F for 35 minutes). The digital data logger was involved. Device of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not available for evaluation (obtain was false).  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1687290; expirationdate: 06-SEP-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2104USA002505: US-009507513-2104USA002841: US-009507513-2104USA002847: US-009507513-2104USA002848: US-009507513-2104USA002849: US-009507513-2104USA002850: US-009507513-2104USA002851: