chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19 PCR test positive; COVID 19 PCR test positive; This is a spontaneous report from a contactable nurse (patient) via a Pfizer-sponsored program. A 57-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3249, Expiry Date: 31May2021), intramuscularly into left arm on 15Jan2021 at a single dose for COVID Prevention. The patient medical history was not reported. There were no concomitant medications. The patient experienced tested positive for COVID on 21Jan2021 after taking 1st dose of COVID vaccine. The patient tested positive for COVID after taking 1st dose of COVID vaccine and was calling to see what she should do about her 2nd dose. The reporter saw in the news that patients can wait up to 6 weeks after receiving the first dose of the vaccine to receive the second, she wants to confirm this information. The reporter was calling on behalf of herself as the patient. The patient got the Pfizer COVID-19 Vaccine last Friday (15Jan2021), and she took a COVID 19 PCR test on 21Jan2021, and the results came back as positive for COVID 19 today 22Jan2021. The patient was wondering what the recommendations are for getting the second dose if a patient tested positive for COVID 19, following having received the first dose. The patient was not complaining about the product, because the product has not had time to work yet. The patient believed the seriousness, it was medically significant because she was losing work over it. Causality: The reporter (patient) did not believe that she got COVID 19 because of the vaccine not working, she just did not think the vaccine had enough time to work before she was exposed. She had no other vaccines on the same day. After she got her first dose, there were a few side effects that she had but nothing was bad, so she was mad when she realized she had gotten COVID, therefore it was not the vaccines fault she got COVID. The reporter had some questions about how this vaccine works in the body. Her doctor thought that her now having tested positive for COVID, that might increase the immune response. The outcome of events was unknown.    Relatedness between reaction COVID-19 PCR test positive and bnt162b2, was unrelated by source of assessment: primary source reporter per method of assessment: Global Introspection.; Sender's Comments: Based on the information currently available, COVID-19 and lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
sore throat, body aches, chills, headache, congestion, fever + COVID test
received first dose of Bexsero on 13Oct2023, and then received second dose too early, on 18Oct2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too short in a 12-year-old female patient who received Men B NVS (Bexsero) (batch number E74MY, expiry date 31-JUL-2024) for prophylaxis.   Concomitant products included MENINGOCOCCAL VACCINE B RFHBP/NADA/NHBA OMV (BEXSERO).   On 18-OCT-2023, the patient received the 2nd dose of Bexsero. On 18-OCT-2023, an unknown time after receiving Bexsero, the patient experienced drug dose administration interval too short (Verbatim: received first dose of Bexsero on 13Oct2023, and then received second dose too early, on 18Oct2023). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK Receipt Date: 18-OCT-2023 The medical assistant reported that, the patient received first dose of Bexsero and then received second dose too early, on 18-OCT-2023, which led to shortening of the vaccination schedule. Both doses were administered from same lot number and expiration date. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Client received her first dose of the Pfizer vaccine and during the post-vaccination wait time, she complained of tingling, warmth and numbness in her tongue and lips. She denied trouble breathing and any itching or rash. She stated that she has a history of anxiety and is allergic to Zoloft, Ativan and mangoes. Her vital signs were as follows: BP=130/95; Pulse=115. ?911? was immediately called and they responded shortly thereafter with Engine number 305. She was evaluated, advised to take Benadryl if needed and was not transported to the hospital.
Left arm became red and inflammed, also hot to touch. Redness extended down to elbow. According to dad arm was so swollen that so much elbow was not visible. No fever. Called Pharmacy and spoke to pharmacist. Was advised by pharmacist to give Benadryl and watch patient.
No adverse reactions after the first two shots. After third shot (1 week post first injection) contractions began at week 36 of pregnancy. Contractions subsided after staying home from work and off my feet for 1 week. Baby was born at 37 weeks and 2 days post 4th dose of rabies vaccine. Contractions and birth of early baby could have been related to the rabies vaccine or not. I thought it was necessary to report given there isn't solid information available for pregnant women.
Numbness in left side of face, droopy left eye, cannot raise eyebrow, cannot completely close left eye lid, cannot smile or raise left side of  mouth. Call to Dr. resulted in visit to emergency room for analysis, overnight stay in hospital, MRI, EKG/ECG, DX X-RAY, LAB/UROLOGY, DX X-RAY/CHEST, CT SCAN/HEAD, LAB/BACT-MICRO, EMERG ROOM, DRUGS-DETAIL CODE, LAB/CHEMISTRY, LABORATORY,  LAB/HEMATOLOGY. Over the course of 4-6 months I've monitored the condition with NO IMPROVEMENT.
This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Severe lower back pain), BURNING SENSATION (Burning sensation on neck, radiates to back and arms) and PARAESTHESIA (Tingling on neck, radiates to back and arms) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027E21A and 027A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included Birth control pills for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced BACK PAIN (Severe lower back pain), BURNING SENSATION (Burning sensation on neck, radiates to back and arms) and PARAESTHESIA (Tingling on neck, radiates to back and arms). At the time of the report, BACK PAIN (Severe lower back pain), BURNING SENSATION (Burning sensation on neck, radiates to back and arms) and PARAESTHESIA (Tingling on neck, radiates to back and arms) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient had received first dose of the vaccine, no side effects following that first dose.
1) Extreme anxiety - moody and irritable following flu vaccine - constant meltdowns.  2) Sensory issues regarding things touching her - sometimes unwilling to put on clothes.  3)  Constant urge to urinate and feeling that she has been incontinent.   Parent concerned it is related to thimerosol.   Has happened twice - all 3 problems happened after getting flu vaccine, two years in a row.
1hr p/vax pt reported to same day clinic w/swelling of the rt eye & itchy throat;
Day 1: Fever in evening. Day 2: Lost appetite, could not keep down TYLENOL, had severe diarrhea. Day 3: Patient given IMMODIUM by spouse. Day 4: 911 called; Blood sugar was 17; Taken to ER and waited 7 hours. Now in ICU for Sepsis.
About 10 minutes after vaccination, the patient fainted. She fell and hit her head on the floor. 911 was called and EMT's came and took her to the emergency room.
This spontaneous report as received from a licensed nurse practitioner refers to a patient of unknown age and gender. It was reported that on 19-JUN-2013 the patient was vaccinated with a first dose of RECOMBIVAX HB 10mcg/ml (dose 1ml intramuscularly: lot number not provided), on 07-JUN-2014 the patient was vaccinated with a second dose of RECOMBIVAX HB 10mcg/ml (dose 1ml intramuscularly; lot number not provided). A third dose of RECOMBIVAX HB had not been given on 17-JUL-2014 (reported "as of today"). No adverse effects were reported. Additional information has been requested.
This case was reported by a healthcare professional, via GSK representative, and described the occurrence of injection site cellulitis in a subject of unspecified age and gender who was vaccinated with KINRIX (GlaxoSmithKline). Concurrent vaccination included VARIVAX (non-gsk); Merck; unknown; unknown given on an unspecified date. On an unspecified date the subject received unspecified dose of KINRIX (.5 ml, unknown route, unknown deltoid). At an unspecified time after vaccination with KINRIX, the subject experienced injection site cellulitis. The subject was treated with Antibiotic. At the time of reporting the event was unresolved. The healthcare professional considered the event was possibly related to vaccination with KINRIX.
She got her vaccine, she slept for 20 hours the following day.  The 2nd day she started having hives.  They were really bad for about a week or so, and felt that it may have been something in the environment, but then realized she had been in bed the day before. She started taking Benadryl and Claritin and using Calamine and hydrocortisone cream.  Her bottom lip swelled up, her hand and the bottom of her feet were also.  She took Prednisone which she already had for 2 a day for 5 days, and then 1 a day for 5 days.  The hives got better, she continued on the Benadryl for a week or so, but it made her very tired and started taking the Allegra instead.   She did a telehealth visit in December as she was having some psoriatic arthritis and prescribed the Prednisone and took Aleve and did not take the Prednisone so had it on hand so when she broke out she took that prescription.    Her reaction now is much better, but still taking the Allegra every day and Claritin as well.  She spoke to the Pharmacy and was told to go to the ER, but her son has COVID and cannot right now, but if it worsens she will go to the ER.  She is also having a little bit of shortness of breath, and has never had this reaction in the past.
Have had night sweats ever since the vaccination. Have heard of others on immune-suppressant therapy having the same problem.
A week after vaccination; Patient experienced extreme erythema, pain, and pustules at injection site. These  affects lasted for 7 days before resolving.
headache; red, slight swelling and hot to touch at vaccination site; vaccination site red; slight swelling at vaccination site; hot to touch at vaccination site; itchy at vaccination site; vaccination site rash; Initial information was received on 27-Aug-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional (Office Staff).  This case is linked to cases 2020SA231242 and 2020SA241537 (same reporter).  This case involves an adult patient (gender unspecified) who had headache, was red, slight swelling and hot to touch at vaccination site (vaccination site inflammation) with symptoms (vaccination site erythema, vaccination site swelling and vaccination site warmth), itchy at vaccination site (vaccination site pruritus) and vaccination site rash, when received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot QFAA2008 via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious headache, was red, slight swelling and hot to touch at vaccination site (vaccination site inflammation) with symptoms (vaccination site erythema, vaccination site swelling and vaccination site warmth), itchy at vaccination site (vaccination site pruritus) and vaccination site rash (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  No laboratory data was provided.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.
Herpes Zoster; This spontaneous report as received from a lawyer regarding a case in litigation refers to a currently 84 years old female patient.  No information was provided regarding concomitant medications, concurrent conditions or medical history.  On 25-MAR-2010 , the patient was vaccinated with a dose of zoster vaccine live(ZOSTAVAX)  for prophylaxis (dose, route of administration, lot number and expiration date were not reported).   On an unknown date, the patient experienced herpes zoster. The outcome of herpes zoster was unknown.   The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Received VARIVAX  3/26/09 mom noted a red area on L arm at injection site. Tender to touch, but not sore with movement. 7 cm by 5 cm warm reaction site noted.
received 2 doses of fluzone hd with no reported adverse event; Initial information received on 05-Oct-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 74-years-old male patient who had received 2 doses of influenza quadrival A-B high dose HV vaccine [Fluzone High-Dose Quadrivalent] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. concomitant: No other vaccines.  On 04-Oct-2023, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot U8132BA via intramuscular route in the left deltoid.   On 18-Sep-2023 patient received 0.7 mL dose (Dose 1) of the influenza quadrival A-B high dose HV vaccine (unknown formulation) (Batch number: U8132BA; expiry date: 30-Jun-2024) via intramuscular route in the right deltoid for Immunization.  On 04-Oct-2023 the patient again received 0.7 mL Dose 2 of influenza quadrival A-B high dose HV vaccine (unknown formulation) (Batch number: U8132BA; expiry date: 30-Jun-2024) via intramuscular route in the left deltoid for Immunization with no reported adverse event (extra dose administered) (same day latency).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event received 2 doses of fluzone hd 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.
Patient c/o itchy feet within 24 hours of receiving his booster.; He developed a rash; Hives all over his body; Dose number: 3; This is a spontaneous report from a contactable reporter (nurse).  A 13-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 17Jan2022 (Lot number: FD7218) at the age of 13 Years as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history was reported as none. It was unknown whether the patient had received any concomitant medications. Past drug history included: Amoxicillin, reaction: "Drug allergy", notes: known allergies: Amoxicillin. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: Unknown; Route of Administration: Unspecified), administration date: 14May2021, when the patient was 12 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE; Lot Number: Unknown; Route of Administration: Unspecified), administration date: 04Jun2021, when the patient was 12 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 17Jan2022, outcome "unknown", described as "Dose number: 3"; PRURITUS (non-serious) with onset 18Jan2022, outcome "not recovered", described as "Patient c/o itchy feet within 24 hours of receiving his booster"; RASH (non-serious) with onset 18Jan2022, outcome "not recovered", described as "He developed a rash"; URTICARIA (non-serious) with onset 18Jan2022, outcome "not recovered", described as "Hives all over his body". The events "Patient c/o itchy feet within 24 hours of receiving his booster.", "He developed a rash" and "Hives all over his body" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pruritus, rash and urticaria.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Since the vaccination, the patient had not been tested for COVID-19. Treatment included oral steroid and topical steroid for pruritus, urticaria and rash.
overdose; Severity of deep muscle aching; was more localized at injected site and considerably less painful.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 60 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in deltoid left, administration date 02Feb2021 09:30 (Lot number: EI 9262) at the age of 60 years as dose 2, 0.5 ml single for COVID-19 immunisation. Relevant medical history included: "Med allergy compazine", start date: 1983, stop date: 1983, notes: pertinent details: Required ER Visit for IV Benadryl-Not taken since; "Med allergy bactrim DS", start date: 2005, stop date: 2005, notes: pertinent details: Biopsies confirmed fixed drug reaction; "Seasonal allergies", start date: 1990 (unspecified if ongoing), notes: pertinent details: Zytec 10mg daily OTC; "COVID-19", start date: 14Oct2020 (unspecified if ongoing); "constipation", start date: 2019 (unspecified if ongoing). Concomitant medication(s) included: cetirizine hydrochloride (ZYRTEC), taken for seasonal allergy; VITAMIN D3 CALCIUM, start date: 2019; ASA, start date: 2019; docusate sodium taken for constipation, start date: 2019. Vaccination history included: BNT162B2 (Dose: 1, Lot number: EK9231, Route: Intramuscular, Anatomical location: LB, dose: 0.5 mL), administration date: 08Jan2021, when the patient was 60 years old, for COVID-19 immunisation, reaction(s): "Deep Muscle ache", "Fever", "Chills". The following information was reported: MYALGIA (non-serious) with onset 2021, outcome "unknown", described as "Severity of deep muscle aching"; VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "unknown", described as "was more localized at injected site and considerably less painful."; OVERDOSE (non-serious) with onset 02Feb2021 09:30, outcome "unknown", described as "overdose". Therapeutic measures were not taken as a result of myalgia, vaccination site pain.  Additional Information: The reporter was also a nurse (patient). The patient had no Family medical history relevant to event. The patient did not undergo relevant tests. The patient did not receive additional vaccine administered on same date of Pfizer suspect. The patient did not receive any prior vaccinations. The Relevant medical history Med allergy Bactrim DS stop date was reported as 16Jan2005. Concomitant medication Vitamin D3 Calcium was taken for women's health and ASA was taken. The outcome of event was reported as unknown (but also reported as: time lag from stop date, if event occurred after cessation of treatment: 2nd injection the day of only). The event were reported as non-serious. The events did not require emergency or physician's office visit.  No follow-up attempts are possible. No further information is expected.
Mental confusion; This spontaneous case was reported by a consumer and describes the occurrence of CONFUSIONAL STATE (Mental confusion) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 014M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (Mental confusion). At the time of the report, CONFUSIONAL STATE (Mental confusion) outcome was unknown.            The reporter was calling on behalf of the patient who received their second dose of Moderna COVID-19 vaccine and had some mental confusion. It was also reported that the patient was on a lot of concomitant medications.  No Concomitant product use was reported. No treatment information was provided.   This case was linked to MOD-2021-402978 (Patient Link).
Lt. deltoid area red, swollen and warm to touch.Mother administered Tylenol.
Pt. first received GARDASIL 9 in her right arm. She was fine and went to waiting room then realized she needed 2nd dose MENACTRA and was given MENACTRA to LA 5 minutes later. Immediately felt dizzy, threw up. V.S. were normal. Observed for 15 Min and sent home. Still sick with head-ache, nausea, poor appetite after 4 days. Physical normal.
has tested positive for an unspecified HPV; This spontaneous report was received from a patient's mother and refers to her daughter, female patient of unknown age. No information regarding the patient's pertinent medical history, concomitant medication, drug reactions and allergies was provided.   On an unknown date, the patient completed the vaccination series of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) injection (dose, frequency, route of administration, lot number and expiration date were not provided) for prophylaxis (reported as prevention of HPV). On an unknown date, the patient had an unspecified human papilloma virus test performed, whose result was positive. The outcome of the event was reported as not recovered.  The relatedness between human papilloma virus test positive and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not provided.
died; This case was reported by a consumer via interactive digital media and described the occurrence of death in a 5-month-old female patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced death (serious criteria death and GSK medically significant). On an unknown date, the outcome of the death was fatal. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the death to be related to DTPa vaccine.  Additional case details were reported as follows: The reporter was patient's grandparent. The age at vaccination was not reported. The patient died from a DTP vaccine. Further information would not be available.; Reported Cause(s) of Death: Unknown cause of death
Immediate sore arm, expected. Then tiredness, also expected. But by ~10-12 hours later, reactions included intensive shivering, (possible) fever, difficulty breathing, confusion, weakness, and an elevated heart rate. Very intense reaction for 5-6 hours, and then something shifted.  I did *not* have hives or swelling.