chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a registered nurse concerning 4 patients who on 28-JUL-2010 were vaccinated subcutaneously with a 0.5 ml dose of VARIVAX (Merck) instead ZOSTAVAX (Merck). No adverse events were reported. It was unknown if the patients sought medical attention. Follow-up information was received from the registered nurse on a phone call. She was unable to provide any patient information: patient name, date of birth and neither lot number. All patients will be revaccinated with ZOSTAVAX (Merck) on 28-AUG-2010. The vaccine mix up occurred due to human error and the VARIVAX (Merck) and ZOSTAVAX (Merck) were now clearly separated. Follow-up information was received from the registered nurse which reported that on 21-JUL-2010 at 4 p.m, the patients were vaccinated subcutaneously into the left arm with a dose of VARIVAX (Merck) (Lot # 665907/1605Y). No adverse reactions reported by the patients. No further information is available.
Patient was only 17 y/o at time of vaccination.  Patient lied on electronic appointment form, our written screening and consent form, and verbally at the pharmacy counter when the patient was asked his date of birth and insurance status.  Patient claimed date of birth to be 12/10/2000 and uninsured when his actual date of birth is 12/10/2004 and he is insured.  The correct date of birth and insurance information was found out from the insurance after the patient received the vaccine and the patient's claim was rejected on 2/9/2022.  The vaccine card that was also presented to be filled out also showed the patient had completed a primary series with Moderna vaccine as well.   The pharmacy tried to call the mom to check on patient and the call was not returned.
Information has been received from a nurse practitioner referring to a 30 year old female patient. Information about concurrent condition, medical history and concomitant therapy was not reported. On 29-APR-2016 the patient was vaccinated with 1 shot of VARIVAX (Merck) (lot# and dose not reported) subcutaneous. The patient stated that the injection was burned while being administered. On the same day, she developed a hot, swollen and red spot at the injection site. The patient sought unspecified medical attention and was given ice to apply to the spot. No lab diagnostic studies were performed. At the time of reporting, the patient was recovering. Additional information has been requested.
local injection site reaction, ipsilateral lymphadenopathy, fever/chills, flu-like illness, brain fog. All symptoms except brain fog resolved in 3 days - brain fog persisted for several more. Pt now asymptomatic.
Started my menstrual cycle 6 days earlier. I started on the 14th, 24 hours after I received the vaccine. I normally start on the 20th of each month.
FluBlok was at 8.4 C for more than 24 hrs, patient did received this FluBlok that was out of range, no AE; Initial and additional information received on 20-Sep-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case is linked to 2019SA267191; 2019SA267208 ; 2019SA267209; 2019SA267210; 2019SA267211; 2019SA267212; 2019SA267213; 2019SA267214; 2019SA267215; 2019SA267216; 2019SA267217; 2019SA267218; 2019SA267219; 2019SA267220; 2019SA267221; 2019SA267222; 2019SA267224; 2019SA267225; 2019SA267226; 2019SA267227; 2019SA267228; 2019SA267229; 2019SA267230; 2019SA267231; 2019SA267232; 2019SA265193.  This case involves a female patient of unknown age who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV], lot QFAA1911, exp date: 27-JUN-2020  via intramuscular route in the left deltoid on an unspecified date which was at 8.4 Degree C for more than 24 hrs and patient did received this Flublok that was out of range.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   No Concomitant vaccine given.  It was a case of actual medication error due to incorrect product storage.  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 holders compliance with the requirements set out in Directive and Module VI of the 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.  Documents held by sender: none.
passed a kidney stone in his urine.; elevated temperature at night.; back pain in his left side.; throw up every hour from waves of pain/vomit every time his pain increased; nausea and vomiting that correlated to the dull burning pain; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (passed a kidney stone in his urine.) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced BODY TEMPERATURE INCREASED (elevated temperature at night.), BACK PAIN (back pain in his left side.), VOMITING (throw up every hour from waves of pain/vomit every time his pain increased) and NAUSEA (nausea and vomiting that correlated to the dull burning pain). On 24-Mar-2021, the patient experienced NEPHROLITHIASIS (passed a kidney stone in his urine.) (seriousness criterion medically significant). At the time of the report, NEPHROLITHIASIS (passed a kidney stone in his urine.), BODY TEMPERATURE INCREASED (elevated temperature at night.), BACK PAIN (back pain in his left side.), VOMITING (throw up every hour from waves of pain/vomit every time his pain increased) and NAUSEA (nausea and vomiting that correlated to the dull burning pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was included One extra strength Tylenol, three naproxens, water and Pedialyte  Based on the current information available and the temporal association between the product use and the onset of the events a causal relationship cannot be excluded.; Sender's Comments: Based on the current information available and the temporal association between the product use and the onset of the events a causal relationship cannot be excluded.
Vertigo that resulted in minor car accident; Vertigo that resulted in minor car accident; Dizziness and nausea lasting for 2 days; Dizziness and nausea lasting for 2 days; Interfered with standing, walking, and completing daily tasks; Interfered with standing, walking, and completing daily tasks; Interfered with standing, walking, and completing daily tasks; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  An 87-year-old male patient received BNT162b2 (BNT162B2), on 14Jul2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 87 years intramuscular, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Type 2 DM" (unspecified if ongoing); "Heart failure" (unspecified if ongoing); "Ventricular arrhythmia" (unspecified if ongoing); "Penicillin allergy" (unspecified if ongoing), notes: known allergies: penicillin (distant history of rash/hives). Concomitant medication(s) included: METFORMIN; GLIMEPIRIDE; FUROSEMIDE; AMIODARONE; CARVEDILOL; LISINOPRIL. Past drug history included: Codeine, reaction(s): "Drug hypersensitivity", notes: known allergies:Codeine. Vaccination history included: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for COVID-19 Immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for COVID-19 Immunization. The following information was reported: DIZZINESS (non-serious), NAUSEA (non-serious) all with onset 15Jul2022, outcome "recovered" (17Jul2022) and all described as "Dizziness and nausea lasting for 2 days"; DYSSTASIA (non-serious), GAIT DISTURBANCE (non-serious), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) all with onset 15Jul2022, outcome "recovering" and all described as "Interfered with standing, walking, and completing daily tasks"; VERTIGO (non-serious), ROAD TRAFFIC ACCIDENT (non-serious) all with onset 15Jul2022, outcome "recovering" and all described as "Vertigo that resulted in minor car accident". Therapeutic measures were not taken as a result of vertigo, road traffic accident, dizziness, nausea, dysstasia, gait disturbance, loss of personal independence in daily activities.  Additional information: It was reported that patient received more than 3 dose of COVID-19 Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Information has been received from a pharmacist concerning a 42 year old female patient with no known drug allergies who in April 2010, was vaccinated with a dose of PNEUMOVAX 23. Within 24 hours of receiving vaccine, the patient experienced redness, swelling and pain at site of injection for a week. The patient also had problems walking because of pain and was examined in an emergency room. The patient was not admitted and was released the same day. Lot number and expiration dates unknown because the hospital did not record lot numbers. At the time of the report, the patient had not recovered. This is one of several reports from the same source. Additional information has been requested.
This case was reported by a healthcare professional and described the occurrence of vomiting in an 18-month-old male subject who was vaccinated with Havrix (GlaxoSmithKline), DTaP (Sanofi Pasteur).  The subject's medical history included celiac sprue.  On 10 July 2007 the subject received 1st dose of Havrix 0.5 (units unspecified) and the 4th dose of DTaP (dose unspecified).  On 10 July 2007, less than one day after vaccination with DTaP and Havrix, the subject experienced vomiting.  The reporting healthcare professional stated that the subject vomited for 10 days following administration of the vaccines, but no treatment was needed.  The reporter also inquired about the gluten content of Havrix.  At the time of reporting the event was unresolved.  Follow-up information was received on 07 August 2007 via a healthcare professional, who reported that the vomiting was resolved as of 23 July 2007.  The reporter listed glutens (wheat, barley, and rice) as co-suspect products for the vomiting.  The healthcare professional considered the event was possibly related to vaccination with Havrix and DTaP, but also indicated the patient's medical history/concurrent illness of celiac disease as a possible cause of the event.  At the time of reporting, the event was resolved.
Per mom patient felt very hot, was shaking, eyes rolled back, not responding appropriately for 10 minutes and vomited.
weakness, falls, fever, SIRS - hospitalized for 2 days at Medical Center - 2/5/2021 - 2/7/2021
A couple of days after receiving the first dose of the Moderna COVID-19 vaccine, I began experiencing severe anxiety and panic attacks, much worse and much more intense than what I would typically experience with my GAD. These panic attacks and intense feelings of anxiety persisted for nearly three weeks.
pain in my left arm; felt weak; left armpit started to hurt; pain moved to the chest; application of the vaccine reddened an area of my arm; it got hot; back ache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 24-year-old (non-pregnant) female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: EW0180), via an unspecified route of administration, administered in arm left on 28Jun2021 16:30 (at the age of 24-year-old) at dose 2, single for covid-19 immunisation. Medical history included asthma. Patient had no known allergies. Concomitant medications were not reported. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Batch/Lot Number: EW0182) via an unspecified route of administration, administered in arm left on 07Jun2021 10:30 (at the age of 24-year-old) at dose 1, single for covid-19 immunisation and experienced pain in the arm that was bearable. 1 dose of the vaccine that patient received on 07Jun2021, after about 2 hours, patient had pain in my arm that was bearable, that pain lasted 3 days. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Reported events: 1 dose of the vaccine that patient received on 07Jun2021, after about 2 hours, patient had pain in my arm that was bearable, that pain lasted 3 days. second dose that patient received on 28Jun2021 at 4:30 pm patient started a pain in patient left arm around 2 hours after the vaccine, after 12 hours after the vaccine patient felt weak, patient left arm hurt. patient left armpit started to hurt and patient took analgesic which helped patient for 8 hours. After this, patient back and both armpits began to ache, but being stronger on the right, but that pain moved to the chest subjecting pressure for about 2-3 min. This on the night of 29Jun2021 to whatever it takes patient another analgesic. Early on 30Jun2021, patient left arm and armpit continued to hurt but patient back and left armpit no longer that night (8:00 pm) patient left arm 3cm below the application of the vaccine an area of patient arm became red for 2 nights and warmed up. Patient already fine. Patient received treatment with analgesic for adverse events. Outcome of the events was resolved on an unspecified date in 2021.
On 26FEB2023 I tested positive for COVID 19, I felt like I had a cold. Fever of 101 I did wake this morning feeling normal. I also feel tired but not too tired, as well as minor body aches nothing major.
localized allergic reaction similar to those I get after a mosquito bite. Over the next 48 hours after receiving the injection, I developed swelling, pain, redness, hotness/itchiness  at the injection site that extends about 3 inches in diameter. It's well-demarcated area that seems to no longer be getting larger.
unable to hear anything; Feeling funny; pale; diaphoretic; This is a spontaneous report from a contactable healthcare professional. An 18-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 intramuscular, administered in Arm Left on 15Apr2021 (Lot Number: EW0164) as single dose for covid-19 immunisation, administered at the hospital. The patient's medical history and concomitant medications were not reported. On 15Apr2021, the patient started "feeling funny", "was unable to hear anything", opened his eyes with a bunch of people standing in front of him; pale, diaphoretic, brought to the emergency department for evaluation. The patient did not receive treatment for the events. Outcome of the events was recovered in Apr2021.; Sender's Comments: Based on the limited information provided and plausible temporal association, the Company (Pfizer) cannot exclude that the suspect medication may have contributed to the reported serious event in this patient. Additional information regarding relevant medical history, underlying conditions  and concomitant medications will aid in the comprehensive assessment of the case. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study 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.
Information has been received from a physician concerning a 6 year old male with a history of eczema. The pt was never on steroids in the past for his eczema. The pt had an exposure to chicken pox in approximately 1999 and according to a physician developed "what sounded like a very typical case of chicken pox." On 09/14/2000, the pt was vaccinated with one dose of varicella vaccine in the right arm. There was no concomitant medication. On 11/11/2001, in the morning, the pt developed redness in his left cheek, which progressed to vesicles by the end of the day. The child contined to develop clear fluid vesicles on the left side of his face, left ear, down the left side of his neck and upper left back. There were some scabs and erythematous papules on his left back. He also had some facial swelling and discomfort. It was noted that the pt had pain and itching. He had a fever of 100.8. The physician reported that the lesions are all on the pt's left side. The physician did not know if this was herpes zoster or a "primary herpes infection." The pt had no recent exposure to chicken pox or herpes zoster. It was noted that other than the past medical hsitroy of eczema and natural chicken pox, the pt was a normal healthy child with no immunosupression. It was noted that the pt had many caretakers and was inadvertently administered the varicella vaccine despite having had chicken pox. On 11/15/2001, a specimen was collected from a vesicle and scab and sent for PCR analysis. The result of the specimen was: PCR identified the presence of VZV; however, it is not able to be typed. The pt fully recovered after treatment with acyclovir. No further info is available.
Patient scheduled a Johnson & Johnson vaccination on our online scheduling system. He came to the pharmacy and said he was here for his Johnson & Johnson vaccination. He said he did not have his insurance card with him.  He  marked on our questionnaire that he had NOT had a previous dose of COVID-19 vaccine.  He was asked to confirm prior to injection what shot he was here for today, he confirmed the Johnson & Johnson. I asked him, "The one dose Johnson & Johnson?" and he confirmed. Three days later we were working on billing for our administration fee. His insurance rejected our claim saying that we must use the same manufacturer for the second dose as was used for the first dose. I then checked on the immunization database and discovered that he had a Moderna vaccination on 5/30/2021 at a drug store. The patient failed to mention this detail at any time during our interactions. I have left multiple voicemails for the patient to contact me or any pharmacist at our store. He has not returned our calls.
patient had not had one since that first time patient got sick. Patient did not plan on getting any. It's been years; Initial information was received on 06-Nov-2020 regarding an unsolicited valid non-serious case from a consumer (patient) via social media.  This case involves a patient of unknown age who got sick (illness), while patient was treated with influenza vaccine.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication was not reported.  On an unknown date, the patient received influenza vaccine [lot number: unknown and expiration date: unknown] at an unknown dose via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (latency: unknown) after starting the suspect vaccine therapy, patient had not had one since that first time patient got sick. Patient did not plan on getting any. It's been years (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, outcome of the event was unknown.  There will be no information available regarding batch number in this case.
A 0.5 mL dose of Moderna 6M-5Y was given to 67 year of age patient
PENTACEL was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no ae; Initial information received on 26-Jan-2022 regarding an unsolicited valid non-serious case was received from an other health professional.  This case involves an intercepted product storage error which involved diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (Pentacel) which was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no adverse event (ae).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient was supposed to receive a dose of suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine (lot UJ523AAA and U6986AA, expiry date: 22-Jul-2022; ) via unknown route in unknown administration site to be given as prophylactic vaccination.  It was reported that on 21-Jan-2022 the diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no adverse event (intercepted product storage error). The reporter enquired if she could still reconstitute and administer the vaccine and if she should wipe off the top of the vial.  Action taken with DIPHTHERIA, TETANUS, AC PERTUSSIS, IPV AND HIB VACCINE (PENTACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (PENTACEL was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no ae).  At time of reporting, the outcome was Unknown for the event pentacel was not reconstituted and the lyophilized vial without the lid was stored at the appropriate temperature range with no ae.  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.
Covid-19 treatment; Covid-19 treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old male patient received BNT162b2 (BNT162B2), on 12Oct2021 as dose 3 (booster), single (Lot number: FE3592) at the age of 68 years for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL; LEVOTHYROXINE; ATORVASTATIN. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 and included Paxlovid.  Clinical course: Anti-viral details: Product- COVID 19 Treatment (Paxlovid) was started from 28May2022. Rebound started from 30Jun2022.