chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID 19; COVID 19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 83-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 06Feb2021 as dose 1, single (Lot number: EN5318), in left arm, on 27Feb2021 as dose 2, single (Lot number: EN6200), in left arm and on 05Nov2021 as dose 3 (booster), single (Lot number: FF2590) at the age of 82 years, in left arm for COVID-19 immunization. The patient's relevant medical history included: "Super ventricular tachycardia" (unspecified if ongoing); "arthritis" (unspecified if ongoing). There were no concomitant medications.The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Indication: Treatment of COVID-19. Therapeutic measures were taken as a result of vaccination failure, COVID-19. Other medication in 2weeks and known allergies were reported as 'No'. Paxlovid was taken by patient for COVID-19 treatment on 30Apr2022 and was stopped on 05May2022.
Pfizer bivalent administered instead of Moderna. As looking at moderna sheet, vaccine was not diluted. 0.2 mL of undiluted pfizer vaccine administered. No tx at this time, no adverse outcome at this time.
This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose was not administered over 4-5 months) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose was not administered over 4-5 months). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose was not administered over 4-5 months) outcome was unknown. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing was delayed on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter.  No treatment medication was provided.      Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Follow up received on 25-May-2021 and contains non significant information.; Reporter's Comments: NA; Sender's Comments: NA
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 52-year-old male patient received BNT162b2 (BNT162B2), on 13Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 51 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 had no relevant medical history. There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
J96.01 ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/27/2023 ADENOCARCINOMA, RIGHT LUNG LOWER LOBE R09.02 HYPOXIA 4/26/2023 ADENOCARCINOMA, RIGHT LUNG LOWER LOBE
3 inch circle in the injection site; raised in injection site; itchy injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (3 inch circle in the injection site), VACCINATION SITE SWELLING (raised in injection site) and VACCINATION SITE PRURITUS (itchy injection site) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE REACTION (3 inch circle in the injection site), VACCINATION SITE SWELLING (raised in injection site) and VACCINATION SITE PRURITUS (itchy injection site). At the time of the report, VACCINATION SITE REACTION (3 inch circle in the injection site), VACCINATION SITE SWELLING (raised in injection site) and VACCINATION SITE PRURITUS (itchy injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Shortly after HPV #2 vaccine, the patient had an episode of nausea, jitteriness, and numbness/tingling in lower extremities. He needed to lay down and nearly had emesis. He was noted to have a low resting heart rate in the 50s-60s and a cardiac murmur. The duration was 15-20 minutes. A similar episode occurred in this patient following the HPV #1, although he also received HepA, Tdap, and Menveo concurrently.
Was noted to have an open wound with surrounding redness/swelling to vaccination injection site on 2/9/2021, was evaluted at Urgent Care and diagnosed with Cellulitis; currently being treated with basic wound care and a course of oral antibiotics.
She started her menstrual cycle 10 days earlier; This is a spontaneous report from a contactable pharmacist. A 42-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown Expiry date: unknown) via an unspecified route of administration on 21Apr2021 as single dose for COVID-19immunization. Patient historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown Expiry date: unknown), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunization. The patient's medical history was not reported. The concomitant medication includes antidepressants; however, unspecified. On 23Apr2021 Patient started menstrual cycle 10 days earlier than normal. pharmacist reports that patient states her menstrual cycle was always regular. Also, mentioned that she was healthy, has no children. The reporter wants to know if Pfizer has any information on this as a reported side effect. The outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Information has been received from a physician concerning an "over 60-years-old" male who on an unspecified date was vaccinated with a dose of ZOSTAVAX.  Subsequently, two weeks later the patient developed chickenpox.  The physician saw the patient and confirmed the diagnosis of chickenpox.  No additional information was provided.  The outcome was not reported.  No product quality complaint was involved.  Additional information has been requested.
4-5 hours after vaccination he developed swelling in the back of his throat and a sensation of his throat closing. He had a change in character of his voice with hoarseness. He developed chest tightness and difficulty swallowing saliva. His uvula was edematous. He had severe throat discomfort. He was evaluated and hospitalized  and required treatment for anaphylaxis with epinephrine, famotidine , IV methylprednisolone and diphenhydramine.
Fatigue, headache, neck pain, back pain, loss of strength in muscles, loss of appetite.  Took client to doctor on (July 4) had blood work.  They treated him fro lyme due to symptoms, was on antibiotics til July 25th still not better.  New doctor put him on stronger antibiotics.  He missed (1) dose and doubled next dose, fever 105 degrees F took off he (feels 95% better).
Pt c/o joint pain & low grade fever, myalgia & HA with subsequent hives (mild).
SOB, low heart rate on Friday November 19 patient sent to ER.  Patient was hospitalized and pacemaker was placed due to 3rd degree block.
Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Sep-2021 at 2:42 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021 at 2:42 PM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 24-Sep-2021 at 2:42 PM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   It was reported that on 24-Sep-2021, patient received the Moderna vaccine which expired on 22-Sep-2021. The patient did not have any adverse events and did not required any medical attention. No problems were reported by the patient.  No concomitant medication was reported. No treatment information was reported.
Patient was administered a 2nd booster dose of 0.25 ml. A dose of 0.25 ml had been administered in Nov 2021
flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The patient could not remember exactly when she had received the 1st dose of Shingrix, but there were three months gap in between both the doses. The patient experienced flu like symptoms, that were worse than having the flu. For the tolerance of 2nd dose of Shingrix refer case US2019141366.
pt recv vax 23DEC95 & 1JAN96 pt exp fever, febrile sz & OM;pt exp necessitated a visit to ER or MD office;6JAN96 pt recovered;no further details were provided;
Vaccinated patient, tested positive and was admitted with COVID on  5/21/2021. Patient passed away on 6/7/2021.
no adverse event; patients received improperly stored vaccines; This spontaneous report was received from a nurse and refers to a unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. Their concomitant therapies included properly stored sterile diluent.  On unknown dates in 2019 (reported as between 01-JUL-2019 and 02-AUG-2019), the patients were vaccinated with improperly stored doses of varicella virus vaccine live (oka/merck) (VARIVAX) injection, lot # R030612, expiration date 23-OCT-2020 and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, lot # S002490, expiration 23-JUL-2020 (doses, routes, vaccination sites and concentration were not reported) for prophylaxis. The temperature was from -14°C to -10°C (-14.2 C) for 6 hours. Previous temperature excursion was from -14°C to -10°C (-14.2 C) for 30 minutes. Digital data logger was involved. No adverse events were reported.   This case was considered to be non-valid due to lack of patients' identifiers.  Upon receipt of follow-up information it was determined that this case is now valid because patient identifier was received.  Follow-up information was received from the nurse on 27-AUG-2019 and refers to two adolescent patients at the age between 13 and 18 years old. On an unknown dates in 2019 (reported as between 01-JUL-2019 and 12-AUG-2019), the patients were vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) lot # R030612, expiration date 23-OCT-2020. There was no reactions or problems with the patients. The freezer was defrosted on 08-AUG-2019 (reported as last Thursday). On 12-AUG-2019, the temperature was -14.9°C for 30 minutes. The clinic manager was checking into getting a lab grade/ vaccine grade freezer. Total hours of excursions was 6 hours and 30 minutes at -14°C.  This is one of 4 cases received from the same reporter.; Sender's Comments:  US-009507513-1908USA010526: US-009507513-1908USA004659: US-009507513-1908USA010528:
This event was historical at age 2 months; I find no record of previous report. The patient received 2 month vaccines. MOP reports decreased responsiveness, "limp" and fever. She was seen in ER and admitted with negative eval. Discharge summary as follows: "HPI: Patient is a 2 month old female who presented to the ED 2 days ago for "breathing weird after shots". She had been a healthy full-term infant born SVD at 40+3 to G3P2 mom and had a normal well baby check the day of admission. At the WBC, she received her 2 month scheduled immunizations at 1030 and was subsequently dropped off at daycare. When picked up, mom noticed breathing concerns and then presented to ED. There she had a rectal temp 103.7, tachypnea to 80s, and tachycardia to 190s, given 50 mg of MOTRIN and admitted for observation. Hospital Course: Since admission, mom reports she has been tolerating bottle well; she exclusively receives SIMILAC q2-3 hours up to 4 oz. She has been producing urine adequately but no stool since day of admission. She has had no acute events through the nights and sleeps well per parents. On the morning of day 2 of hospital stay she had significant nasal congestion that brought on increased breathing effort and subcostal retractions. This resolved promptly after saline and suction and she has had only one mild episode requiring suction since. She has remained afebrile with no O2 requirements or need for fluid support, with stable vitals. PE: Vitals: Temp 97.8-98.8F, HR 128-132, RR 40-42, Pulse ox 100% on RA, Admit weight 5300g General: Resting comfortably, mildly fussy but consolable on arousal Head: Atraumatic/normocephalic, Anterior fontanel open, soft, and flat Nose: No secretions noted, adequate air movement Mouth: Moist Mucosa Lungs: CTA with mild upper airway sounds transmitting nasal congestion but good air movement Heart: RRR, no murmurs appreciated Abdomen: Soft, NT/ND, no hepatosplenomegaly; normal BS Pulses: Femoral 2+ bilat Extremities: Symmetric appropriate tone throughout; cap refill <2 sec Skin: No rashes or discoloration A/P: This is a 2 month old previously healthy, full term female infant who presented with fever, tachycardia, tachypnea, and fussiness. This is a very common reaction to DTaP vaccine, with 1/4 children experiencing fever and 1/3 of children experiencing prolonged fussiness. This adverse reaction typically occurs several hours after the vaccine and resolves without sequelae. Patient was counseled no need to deviate from immunization schedule. Her nasal congestion may represent a concurrent viral URI that is resulting in secretions and stuffiness. Her decreased H&H likely represents the physiologic nadir known to occur around 2 months of life but should be followed up by PCM. Her stable vital signs and improvement on the ward are reassuring that she can be discharged to home with outpatient follow up Friday."
Pins and needles in areas of right arm and leg/foot; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Mar2021 at 16:00 (at the age of 63-years-old), as a single dose for COVID-19 immunisation. Medical history included A-Fib heart. The patient had no allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included apixaban (ELIQUIS) 5mg, diltiazem 120mg (MANUFACTURER UNKNOWN) and rosuvastatin 5mg (MANUFACTURER UNKNOWN); all for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 31Mar2021 at 07:00, the patient experienced pins and needles in areas of right arm and leg/foot the day after vaccination. Pins and needles had occurred non-stop for the past month (as per the date of this report). The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event pins and needles in areas of right arm and leg/foot the day after vaccination was not recovered at the time of the report.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
arm is spotchy near injection site; arm is red near injection site; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (arm is spotchy near injection site) and INJECTION SITE ERYTHEMA (arm is red near injection site) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced ERYTHEMA (arm is spotchy near injection site) and INJECTION SITE ERYTHEMA (arm is red near injection site). At the time of the report, ERYTHEMA (arm is spotchy near injection site) and INJECTION SITE ERYTHEMA (arm is red near injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.   No treatment information was provided.
Muscle aches; Joint aches; Headache; Fatigue; Foggy feeling; Nasal drippage; Nasal congestion; Arm pain; Dose received- 3; Dose received- 3; This is a spontaneous report from a contactable healthcare professional, the patient.  A 31-year-old non-pregnant female patient received the third dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 30Sep2021 at 16:00 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and anxiety. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included paracetamol (TYLENOL), lamotrigine (LAMICTAL), caffeine, mepyramine maleate, paracetamol (MIDOL) and vitamin d nos (VITAMIN D); all for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 25Jan2021 at 08:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 04Jan2021 at 08:00 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. On 01Oct2021 at 06:00, the patient experienced muscle and joint aches next day, headache, fatigue, foggy feeling, nasal drippage and congestion and arm pain. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events muscle and joint aches, headache, fatigue, foggy feeling, nasal drippage and congestion and arm pain was resolving at the time of this report.
The patient passed away; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (The patient passed away) in a 56-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on 01-Nov-2021 The patient died on 01-Nov-2021. The cause of death was not reported. It is unknown if an autopsy was performed.            No concomitant medication reported. No Treatment Medication reported.  Company comment This is a spontaneous case concerning a 56-year-old male patient with no relevant medical history reported, who experienced serious, unexpected event of death. The event occurred on an unknown date after receiving a dose of mRNA-1273 vaccine. The patient died on 01-Nov-2021. The cause of death was not reported. It is unknown if an autopsy was performed.  Very limited information regarding this event has been provided at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a 56-year-old male patient with no relevant medical history reported, who experienced serious, unexpected event of death. The event occurred on an unknown date after receiving a dose of mRNA-1273 vaccine. The patient died on 01-Nov-2021. The cause of death was not reported. It is unknown if an autopsy was performed.  Very limited information regarding this event has been provided at this time. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death
PT complained of tingling in arm and a pressure in the Left ear.   Pt was given 50mg of Benadryl and was asked to remain seated for 30 minutes.
Sore throat and fatigue since she got 2nd dose of Moderna vaccine. Denies cough, chest pain, difficult breathing or fever.
Multiple Patients received expired dose of the Moderna vaccine.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Multiple Patients received expired dose of the Moderna vaccine.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Multiple Patients received expired dose of the Moderna vaccine.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Multiple Patients received expired dose of the Moderna vaccine.) had resolved.            No relevant concomitant medications were reported. No treatment information was provided.