chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tremors; could not walk the next day; This is a spontaneous report from a contactable consumer (patient himself). A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Apr2021 (Batch/Lot number and Expiration date were unknown) as the 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient could not walk next day (10Apr2021), was in the hospital and had tremors on an unspecified date, and was using a walker at the time of the report. The patient wanted to know if he should get the 2nd vaccine the day after the report (26May2021). The events led to hospitalization on an unspecified date. Therapeutic measures were taken as a result of the event "could not walk the next day." The outcome of the events was unknown.  Information on the batch/lot number has been requested.
Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 022M0A) for COVID-19 vaccination.     No medical history was reported.  The patient's past medical history included Pregnancy (Live full time birth, healthy baby.) on 18-Jan-2019. Concurrent medical conditions included Nickel sensitivity (allergy to Nickel( causes rash)). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Feb-2020 to an unknown date for Pregnancy.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 08-Jun-2020 and the estimated date of delivery was 14-Feb-2021. On 22-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-second week of the pregnancy. The delivery occurred  on 19-Jan-2019, which was reported as Normal Pregnancy Outcome. For neonate 1, The outcome was reported as Delivered NOS. menstruation date is not an error: I had a full period during first month of pregnancy. Baby was born healthy. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In June 2020, Ultrasound foetal: normal (normal) Normal. In October 2020, Ultrasound foetal: normal (normal) Normal. In November 2020, Blood glucose: normal (normal) Normal.         Prenatal care was established.  The patient's positive pregnancy test was on 30-Jun-2020 and estimated date of conception was 24-May-2020.  The patient had a full period during first month of pregnancy. The baby was born healthy.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Reporter Details were Updated
This spontaneous report was received from an unspecified source via published article referring to a 900 unspecified children of unknown age and gender. No information regarding the patients' medical history, concurrent conditions or concomitant therapies was provided. On an unknown dates, the patients were vaccinated with a dose of ZOSTAVAX (strength, dose number, route, frequency, lot number and expiration date were not provided) for prophylaxis, through a free or low-cost vaccine program. It was reported that during a routine compliance visit, problems with refrigeration temperatures were discovered. Also, it was reported that the vaccines were not stored properly at the right temperatures, which possibly reduced their effectiveness and the temperature problems may had occurred as early as November 2014. The children who should be evaluated for revaccination were vaccinated between November 2014 and 28-JUL-2016. Additionally, it was reported that the possible ineffective vaccines did not pose any health dangers to the children who received them but those children may not be fully protected against vaccine-preventable diseases. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA005965: US-009507513-1701USA005969: US-009507513-1701USA005967: US-009507513-1701USA004881: US-009507513-1701USA005964: US-009507513-1701USA005966.
MA realized after the patient left that the immunization had expired on 4/15/17. The patient did not have any reactions.
Patient developed hives/rash all over his body approximately 40 minutes after Hepatitis A (first dose) and MENVEO (second dose) vaccine administration. BENADRYL and ATARAX were both administered to patient. Rash/Hives began to improve shortly after administration of BENADRYL and ATARAX.
Dizziness when prone/in process of laying down/getting up - started about a day after positive test - comes and goes
The first Pfizer vaccine shot was administered on Sunday, September 19, 2021. On Monday, September 27, 2021, I started feeling dizzy and lightheaded at around 4:10 pm. During the next couple of minutes, the symptoms continued to worsen and my complexion changed to very pale. By 4:30 pm, I started suffering from fast heart palpitations; strong pain in nape of my neck; I felt tingling and numbness all over my body; I had slurred speech; and shortness of breath resulting in difficulty breathing. My family called 911. The paramedics arrived and administered oxygen and determined that I needed to be taken to the hospital. During the hospital trip, the tingling and numbness throughout my body persisted along with muscle spasm. Once I was at the hospital, I was placed on an IV and had X-rays and blood drawn 3 times. I was told my white blood cell count was low, hence the reason for multiple bloodwork exams. I was discharged after my white blood cell count returned to normal. Symptoms best described as similar to a stroke or myocarditis. I was advised to follow-up with my primary doctor, which I have contacted and given an appointment for October 13, 2021. I was told to return to the ER if I felt the symptoms returning.
Patient seen in prior week for viral type illness, had unremarkable CBCs, recovering fairly well, seen on 4/9/04, assessed as stable enough for shots, given standard Pediarix, Hib and Prevnar.  No history known to me about weekend, taken to day care, respiratory arrest described.  Taken to ER, seen by MD, resusitation unsuccessful.
Patient was given a booster dose of Pfizer Covid-19 vaccine in the the left arm. Patient was seated and responsive upon initial administration of vaccine. Within 2 to 3 minutes of administration, patient began to have seizure like symptoms with noticeable saliva coming out of mouth. Patient was unresponsive for roughly 1 to 2 minutes while the healthcare team stabilized the patient. Patient regained consciousness after 2 minutes and described feeling tingling all over their body. Patient's vital signs were checked. Their blood pressure was 114/78 mmHg  and heart rate was 77 bpm. There were no signs of anaphylaxis or rash noted. Patient was given some water and monitored for several minutes. Patient was feeling better after about 20 minutes. They were able to walk around unassisted after roughly 30 minutes.
Patient had severe pain radiating up to his left neck, chills and body aches. He had severe palpitations. He went online and checked at website and read that the severe palpitation could happen to 1 in 50 people. He called his MD too.
I woke up that morning with a sore throat and a fever, I could not find my thermometer and felt like I had a sinus infection that was really draining.  I started having sinus congestion and shortness of breath and I went to the hospital and I was tested in a separate room for a COVID-19 nasal swab test and they called me the next day and let me know that I was positive and set me up for an appointment for me to have the antibody infusion.
pt came in today for booster MMR & stated that w/MMR given in MAR94 lt upper arm became very red & swollen traveling down to ax & upper breast; did not resolved until 2 wks p/;
unable to sleep on my left side; prevented me from doing my regular chores; couldn't move it as much; Sore back; low grade fever of 99.7; swollen lymph nodes; Sore arm; tingling on the face started about an hour; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Sore back), PARAESTHESIA (tingling on the face started about an hour), INSOMNIA (unable to sleep on my left side), IMPAIRED WORK ABILITY (prevented me from doing my regular chores) and MOBILITY DECREASED (couldn't move it as much) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Aug-2021 at 4:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Aug-2021, the patient experienced PARAESTHESIA (tingling on the face started about an hour). On 28-Aug-2021, the patient experienced MYALGIA (Sore arm). On 29-Aug-2021, the patient experienced LYMPHADENOPATHY (swollen lymph nodes). On an unknown date, the patient experienced BACK PAIN (Sore back), INSOMNIA (unable to sleep on my left side), IMPAIRED WORK ABILITY (prevented me from doing my regular chores), MOBILITY DECREASED (couldn't move it as much) and PYREXIA (low grade fever of 99.7). On 27-Aug-2021, PARAESTHESIA (tingling on the face started about an hour) had resolved. On 04-Sep-2021, LYMPHADENOPATHY (swollen lymph nodes) had resolved with sequelae. At the time of the report, BACK PAIN (Sore back), INSOMNIA (unable to sleep on my left side), IMPAIRED WORK ABILITY (prevented me from doing my regular chores), MOBILITY DECREASED (couldn't move it as much), MYALGIA (Sore arm) and PYREXIA (low grade fever of 99.7) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Jan-2021, SARS-CoV-2 test: positive (Positive) Nasal swab for COVID-19 Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.   Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-up received and updated event, lab data and patient demographics information.
administered 0.5ml vaccination of Daptacel in the left thigh, SQ instead of IM/no AE; Initial information regarding an unsolicited valid non-serious case was received from an other health care professional via Medical Information  (Reference number- 00318955) and transmitted to Sanofi on 16-Oct-2020.  This case involves a 4-year-old male patient who was vaccinated with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE [DAPTACEL] (suspension for injection), (batch number: C5706AA and expiry date: 11-Mar-2022) (in the left thigh via subcutaneous route, the vaccine was administered) (incorrect route of product administration) on 15-Oct-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, vaccination and family history were not provided.  Concomitant medication of the patient included measles vaccine/mumps vaccine/ rubella vaccine (MMR), INFLUENZA VACCINE and Aracilla (not coded).  It was an actual medication error case due to incorrect route of drug administration (latency: same day) At the time of reporting, 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 available regarding batch number in this case.
Pressure in chest, light-headedness, tingling in arms continuing for two weeks after initial symptoms.
blood pressure went "way up when se got her COVID; This is a spontaneous report from a contactable physician, based on information received by Pfizer. (manufacturer control number: EC-2019-065480), for BNT162B2.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization and patient had received lenvatinib mesilate (LENVIMA), via an unspecified route of administration from 19Apr2021 (Batch/Lot number was not reported) to an unspecified date, at unspecified dose for unknown indication. Medical history included thyroid cancer from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date it was reported that, patient daughter advised patient blood pressure went "way up when she got her COVID vaccine". Pfizer was vaccine brand. Patient blood pressure has come back down to normal. Patient was told to hold Lenvima for a few days due the high blood pressure and has since resumed at her regular dose. The patient underwent lab tests and procedures which included blood pressure measurement: went way up and has come back down to normal on an unspecified date. The action taken in response to the event for lenvatinib mesilate was temporarily withdrawn on an unspecified date. The outcome of event was unknown.
Eczema rash is present over both proximal arms. Area on right arm is 12 x 5 cm. Area on left arm is 8 by 6 1/2 cm.
Information has been received from a physician via Company representative concerning to a patient of unknown age and gender. Concurrent and historical conditions were not reported. Concomitant therapies were not provided. On 15-MAY-2015, the patient was vaccinated with an improperly stored dose of GARDASIL (Lot No. K001631, exp. 06-NOV-2016) (dose and site not reported). The vaccine was in excursion with a sum of hours of 192, 208, 512, 24, 1000, 472, 136 and 32. The lowest recorded temperatures were of 31, 27, 28, 29, 30, 26, 34 and 32 respectively. The vaccine status was reported as "in excursion". The vaccine storage criteria and type were reported as "refrigerator (R)". No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
he slept for 15 hours woke up at 5:00pm high temp 37.1 Celsius/in the afternoon the temperature increased to 38.4 Celsius; a little muscle pain; This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team. The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), on 08Apr2022 at 14:15 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I contracted Covid-19", start date: 16Dec2021, stop date: 16Dec2021, notes: On 16Dec, I contracted Covid-19, and recovered, I don't know if I am covered and immunity. The patient's concomitant medications were not reported. The following information was reported: MYALGIA (non-serious) with onset 09Apr2022 at 17:00, outcome "unknown", described as "a little muscle pain"; BODY TEMPERATURE INCREASED (non-serious) with onset 09Apr2022 at 17:00, outcome "unknown", described as "he slept for 15 hours woke up at 5:00pm high temp 37.1 Celsius/in the afternoon the temperature increased to 38.4 Celsius". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Batch/lot number, NDC number and Expiry Date of Pfizer vaccine were not Provided. Other Products, Other Conditions and Investigations were not Provided. The reporter is a physician who took the first dose of the Pfizer Covid vaccine on 08Apr at 2:15 pm. Stated that for the next 15 hours that he was fine then slept. He states he had some issues, he slept for 15 hours woke up at 5:00 pm with a high temperature 37.1 degrees Celsius, and had a little muscle pain, and later on in the afternoon the temperature increased to 38.4 Celsius. He wanted to know if he should take the fever reducer. He was fine until very early in the morning like 5:00 am, He had a slight increase in temperature, and he thought it would improve, but then during the day, it increased to 38 degrees, and then 38.4. What my concern is that if I take Tylenol, I know it will reduce the fever, but my concern is, how will it affect the vaccine's performance? Can I take a Tylenol, or do I wait it out. The reporter wanted to know, "How does taking Tylenol, affect the action and efficacy of the Pfizer Covid vaccine? "On 16Dec, he contracted Covid-19, and recovered, he doesn't know if he is covered and immunity for life, Pfizer should know. Due to the fact that the vaccine needs mediators, but if you take medicine will it affect the vaccine's effectiveness, because its effectiveness depends on the mediators to generate antibodies. How does taking fever medicine affect the vaccine's ability to generate antibodies.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
In addition to the 4 vaccines given above, see #17 - Covid 19 Pfizer-BioNTeck Vaccine 0.2 ml dose given  (age 6 mo to less than 5 years old).  Dose given was not diluted, resulting in 15 mcg being administered instead of 3 mcg which is the normal diluted dose. MD was notified assoon as discovered the day the dose administered, but after the patient left the clinic. There was no reaction in the 15 min observation period in the clinic after administration. MD documented 11/4/22 reassessment of patient via phone call with parents who denied any side effects other than 1-2 days febrile and feeling acutely ill, which is now fully resolved. MD recommended follow up in 304 months for rest of her vaccines.
Vaccine was administered to patient past the BUD of 17-Feb-2023; No adverse event; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 065H22A) for COVID-19 prophylaxis.     Patient did not report any medical history, conditions, allergy, concomitant diseases, or risk factor (including any previous COVID-19 diagnosis). It was reported that patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to patient past the BUD of 17-Feb-2023).    Concomitant drugs were not reported. It was reported that vaccines were administered to 20 patients between 13-Mar-2023 to 05-Jun-2023 past the BUD of 17-Feb-2023. Patients received the vaccine either as the 3rd, 4th or 5th dose. Treatment medications were not provided. This case was reported for patient 7 of 20.   This case was linked to US-MODERNATX, INC.-MOD-2023-727707 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-727707:Master Case(Patient 1)
FEELING OF WARMTH; NASAL STUFFINESS; FLU LIKE SYMPTOMS; BODY ACHES; SWEATING; CHILLS; TIREDNESS; This spontaneous report received from a patient concerned a 47 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included cigarette smoker, asthma, allergies, and anxiety. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: UNKNOWN) dose was not reported, administered on 05-APR-2021 for prophylactic vaccination. Concomitant medications included Montelukast. On 06-APR-2021, the subject experienced tiredness. On 07-APR-2021, the subject experienced feeling of warmth. On 07-APR-2021, the subject experienced nasal stuffiness. On 07-APR-2021, the subject experienced flu like symptoms. On 07-APR-2021, the subject experienced body aches. On 07-APR-2021, the subject experienced sweating. On 07-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of the tiredness, chills, feeling of warmth, nasal stuffiness, flu like symptoms, body aches and sweating was not reported. This report was non-serious.
This initial spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions or drug allergies/drug reactions described. It was reported that on an unknown date, the patient had an unspecified reaction to thimerosal content in an unspecified vaccine administered on an unknown date. As potentially suspect the vaccine administered could be RECOMBIVAX HB (dose, frequency, route and lot# were not reported). It was unknown if the patient sought medical attention. Product quality complaint (PQC) was not involved. At the time of the report, the outcome of the unspecified reaction was unknown. Additional information is not expected as the reporter did not wish further contact.
patient was given a vaccine that was expired. it was drawn at 3 pm on 09/01/21 so it expired after 6 hours upon contacting manufacturer they provided me with additional internal data that states dose chemical properties are unaffected until after 24 hours form drawing. a decition was made to not readminister
caught the flu; Initial information received on 09-Jan-2023 regarding an unsolicited valid social media non-serious case from a consumer/non-hcp.  This case involves an unknown age female patient who caught the flu after receiving vaccine influenza vaccine.  The patient's past medical treatment(s), vaccination(s), concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date in Nov-2022, the patient received suspect influenza vaccine produced by unknown manufacturer at an unknown dose (lot number, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (immunisation).  On 01-Jan-2023 the patient developed a non-serious caught the flu (influenza) (approximately 2 months latency) following the administration of influenza vaccine.  It is unknown if there were lab data/results available.  Action taken: Not applicable.  Corrective treatment: Not reported.  Outcome: Not Recovered / Not Resolved for the event caught the flu.