chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Mental fog; Acid reflux; Chest pain; Diaphoretic; Exhaustion; Muscle pain; Joint pain; Fever; Chills; Nausea; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received her second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0172) via an unspecified route of administration in the left arm on 01May2021 at 08:45 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient did not receive any other medications within two weeks of vaccination. The patient previously took Keflex and had received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0162) via an unspecified route of administration in the left arm on 10Apr2021 at 09:00 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021 at 11:00, the patient had experienced mental fog, exhaustion, muscle pain, joint pain, fever, chills, diaphoretic, nausea, acid reflux and chest pain. The clinical outcome of the events mental fog, exhaustion, muscle pain, joint pain, fever, chills, diaphoretic, nausea, acid reflux and chest pain was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
This spontaneous report as received from a nurse refers to a 15 year old patient of unknown gender. The patient's concurrent condition, medical history, drug reactions/allergies and concomitant medication were not reported. On 26-JUL-2017, the patient was vaccinated with a dose of PROQUAD for prophylaxis, which was outside of the recommendations in the vaccine prescribing information (inappropriate schedule of drug administration). No adverse effects were reported. This is one of the two reports received from the same reporter (MARRS# 1707USA011604). Additional information has been requested.; Sender's Comments: US-009507513-1707USA011604:
Blue/purplish marks keep appearing on different parts of my body, specifically my arm and lower legs. Not sure if they are blood clots or bruise marks but they are not painful. The first one appeared on the back of my right arm near my elbow. One that appeared on my left l calf was large, about the size of an egg. The others have been the size of a nickel or quarter. They appear spontaneously 1 at  a time and last for approximately 4-6 days. During that time they turn greenish and then yellowish before they totally disappear. I have had approximately  7-8 separate instances of these marks appearing.
dementia like side effects; This is a spontaneous report from a contactable consumer. This consumer reported similar event for two patients. This is the first of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunisation. The patient medical history included known allergies (unspecified). The patient had no covid prior vaccination. The patient's concomitant medications were not reported. The patient had no other vaccine in four weeks. On 22Mar2021, the patient experienced developed dementia like side effects that didn't exist prior. The event was reported as life threatening illness (immediate risk of death from the event) and resulted in emergency room/department or urgent care. Unspecified treatment was given to the patient in hospice. Patient was not tested for covid post vaccination. The outcome of the event dementia like side effects was not recovered.   Information on batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021382963 Same reporter/drug/event, different patient.
Patient was given the DTap/IPV portion of PENTACEL, but not the ActHIB portion with no reported adverse event; Initial information received on 02-Nov-2021 regarding an unsolicited valid non-serious case from a other health professional via Agency (under reference number 0083849).  This case involves a 6 months old male patient who was given the dtap/ipv portion of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)], but not the acthib portion (product preparation issue).  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and HEPATITIS B VACCINE (lot numbers and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination on an unknown date.  On 27-Oct-2021, the patient received a 0.5 ml third standard dose in total of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE (once , lot UJ527AA and expiration date not reported) via intramuscular route in the left thigh for prophylactic vaccination (the caller stated that she had the same lot and expiration date for both components of the PENTACEL vaccine).  It was an actual medication error case due to inappropriate reconstitution technique (same day latency).  It was reported "Nurse reported that a patient was given the DTap/IPV portion of PENTACEL, but not the ActHIB portion. The caller would like to speak with someone about obtaining the diluent portion of ActHIB. Caller declined to provide her email address. I referred the caller to the PENTACEL reconstitution video. I spoke with a Pasteur Customer Service Representative and they will contact the caller."  No treatment required post administration was provided to the patient.  At time of reporting, no adverse event was reported and the outcome was unknown for the 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.
Began getting feverish, sore throat, aches, and tiredness on Thursday night. Did Covid test Friday which was negative. Slept most of weekend with same symptoms. Retested Monday to a positive test for Covid. Partner also tested Monday to positive Covid.
Red, warm, swollen vaccine site day after vaccine. Fever/chills/headache developed 2 days after vaccine.
Patient presented with substantial bruising around indicated injection site. Outside of this bruising, patient had red patches of rash skin. No treatment provided.
Mom stated pt started to twitch (non-seizure) pale, dizzy, clammy. C/o numbness to leg. Tx patient was put in room. Elevated (B) legs. Ambulance called.
Fever/Chills on the night of vaccine (11/16/2020). Ischemic stroke on 11/19/2020, which happened approximately 6:00 am EST, with stroke residual side effects (drooping left side of the face, limp leg/arm)setting in around 3:00 pm EST. Stroke side effects have worsened to a total loss of use of the left arm, unable to walk without assistance. Still in hospital from stroke as of 11/21/2020. Unknown if he will recover.
Vaccine was open 11/3/22 at 8:30 am, and was given to patient at 11/4/22 and 11am. The vaccine was in fridge this entire time but was given to the patient after the 12 hour time. Should have been discarded after 12  hours in the fridge.
the patient was administered a dose of VARIVAX on 1/4/2020, that had been improperly stored; This spontaneous report was received from the vaccine coordinator, referring to a patient of unknown age an gender. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 04-JAN-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S021926 and expiration date: 15-JUL-2021 (dose, frequency, route and anatomical location were not provided) for prophylaxis. The administered dose of the vaccine was stored with the temperature of 1.2 degrees centigrades for 3 hours and 9 minutes. There was a digital data logger involved, but there was no previous temperature excursion. The vaccine was reconstituted with a properly stored sterile diluent. No additional adverse events reported.
This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient's unspecified allergic reaction to Penicillin and macrolides. On 27-JAN-2016, the patient was vaccinated with ZOSTAVAX (strength, dose, frequency, route and indication were not reported) for prevention of shingles at an unspecified physician's office. Concomitant medications were not reported. On an unknown date in 2016, the patient experienced a small nodule at the injection site. The patient informed that she had no rash. The patient sought medical attention by contacting the pharmacist and no treatment was given for the event. Product quality complaint was not involved. The outcome of the event was unknown. Causality assessment was not provided. Additional information has been requested.
Fever to 105, confusion, WBC increase 26,000 within 24 hrs of receiving a flu vaccine and Pneumococcal vaccine. Required ER visit IV hydration.
Woke up with heart pounding. Felt like it was beating very hard/abnormally in addition to speed. Watch read 110 then kept rising to 164 in less than 20 seconds. Called 911. Paramedics checked my heart at home and said it was the vaccine but that I was ok
Right armpit swollen with a hard lump in the middle, started a day and a half after shot.
the first one hit me hard; normal pain; high fever; headache; body ache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (the first one hit me hard), PAIN (normal pain), PYREXIA (high fever), HEADACHE (headache) and MYALGIA (body ache) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040821A) for COVID-19 vaccination.     The patient's past medical history included Surgery (had surgery a few years ago).    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, the patient experienced FEELING ABNORMAL (the first one hit me hard), PAIN (normal pain), PYREXIA (high fever), HEADACHE (headache) and MYALGIA (body ache). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (the first one hit me hard), PAIN (normal pain), PYREXIA (high fever), HEADACHE (headache) and MYALGIA (body ache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       No concomitant medications were reported.   This case was linked to MOD-2021-132606 (Patient Link).
pt states that her sugar level started dropping and her skin felt like it was burning.  She felt like she was on fire.  She took ibuprofen and then took a norco but nothing helped.  She took a shower and noticed she had small cluster of blisters from her eye down her face, in her mouth, on her neck,  and on her back.  She thought she had shingles.  These blisters lasted about 3 days and started to go away but her skin was still burning.  She had spots on her skins that would start whelping up into red blisters (the sizes varied from the size of golf balls to the size of baseballs)  These spots were swollen, hot to the touch and burning.  She developed these spots all over her body including her eyes which she her right eye was blurry and the left eye was swollen shut.  This lasted about 4 days.  She went to the ER and was prescribed antihistamines.  She was told to FU w/ her PCP which referred her to see her dermatologist.   She was prescribed multiple strong antihistamines due to having severe allergic reaction.  She has had several blood and urine test and has to go back this Monday for further testing.  She still has these bumps popping randomly all over her body but they are smaller than they were before.  Her sugar level dropped to 30 and stayed under 90 for at least 3 weeks after her vaccine.  Her sugar levels are still not normal and she still has blisters 2 months later.  She also has continuous interment fatigue and flu like symptoms since this vaccine. 1st Covid Vaccine Pfizer on 4/22/2021 Lot # EW0153 left arm. 2nd Covid Vaccine Pfizer on 5/12/2021 Lot # EW0173 left arm.
Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Feb-2022; Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Feb-2022; This spontaneous case was reported by an emergency medical technician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Feb-2022) in a 23-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Feb-2022 at 2:13 PM, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 05-Feb-2022 at 2:13 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Feb-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Feb-2022) and PRODUCT STORAGE ERROR (Vaccine went into 2-8 Celsius thaw state on or about 24-Dec-2021 and administered on 05-Feb-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported.  Patient received vaccine past its 30 day expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022. Reporter no longer possess this lot number.   This case was linked to MOD-2022-542869 (Patient Link).
This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 64-year-old male patient who received BOOSTRIX (batch number B7PC3, expiry date 12th September 2016). Co-suspect products included FLUARIX QUADRIVALENT (batch number 9525T, expiry date 12th June 2016). On 22nd September 2015, the patient received BOOSTRIX (intramuscular) .5 ml and FLUARIX QUADRIVALENT (intramuscular) .5 ml. On 23rd September 2015, 1 days after receiving BOOSTRIX and FLUARIX QUADRIVALENT, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was not recovered/not resolved. It was unknown if the reporter considered the injection site rash to be related to BOOSTRIX and FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was not previously reported to anyone. On the same day, the patient received BOOSTRIX in left deltoid and FLUARIX vaccine in right deltoid. The patient experienced a rash on his both upper arms. The patient did not experience pain, itching and fever. On 7th October 2015, the patient told the pharmacist that the rash was not resolved.
SORE MOUTH; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 54 year old female. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, 1 total administered on 15-MAR-2021 on left arm for prophylactic vaccination. No concomitant medications were reported.  On 15-MAR-2021, the subject experienced headache. On 31-MAR-2021, the subject experienced sore mouth. On 31-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache on 18-MAR-2021, and had not recovered from fever, and sore mouth. This report was non-serious.
Approximately 24 hours later became nauseated and fever went to 101 degrees F. Temp stayed elevated until 11/166 in the evening went down to 99.6 F. Injection site hurts and there is a knot. Also has a knot underneath armpit.
patient recieved an expired dose of shingrix on Aug 29th 2023 and it was expired on 8/28/2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 57-year-old female patient who received Herpes zoster (Shingrix) (expiry date 28-AUG-2023) for prophylaxis.   On 29-AUG-2023, the patient received the 2nd dose of Shingrix. On 29-AUG-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: patient recieved an expired dose of shingrix on Aug 29th 2023 and it was expired on 8/28/2023).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 29-Aug-2023 The reporter consented to follow-up. The patient received an expire dose of Shingrix, which led to expired vaccine used.
This spontaneous report was received from a nurse refers to a 1 year old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided. On 11-NOV-2016, the patient was vaccinated with a dose of PROQUAD (lot # M015695, expiry date: 26-SEP-2017) and a dose of VARIVAX (lot # M028551, expiry date: 07-JUN-2018) in the same office visit. No adverse effects were reported. Additional information has been requested.
both arms , thighs and her stomach got very itchy; sweats; hot and cold flashes; CHILLS; very horrible headache; very tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (both arms , thighs and her stomach got very itchy), HYPERHIDROSIS (sweats), FEELING OF BODY TEMPERATURE CHANGE (hot and cold flashes), CHILLS (CHILLS) and HEADACHE (very horrible headache) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 02-Mar-2021 at 9:45 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced HYPERHIDROSIS (sweats), FEELING OF BODY TEMPERATURE CHANGE (hot and cold flashes), CHILLS (CHILLS), HEADACHE (very horrible headache) and FATIGUE (very tired). On 02-Mar-2021 at 7:00 PM, the patient experienced PRURITUS (both arms , thighs and her stomach got very itchy). On 02-Mar-2021 at 8:30 PM, PRURITUS (both arms , thighs and her stomach got very itchy) had resolved. On 04-Mar-2021, HYPERHIDROSIS (sweats), FEELING OF BODY TEMPERATURE CHANGE (hot and cold flashes), CHILLS (CHILLS) and HEADACHE (very horrible headache) had resolved. At the time of the report, FATIGUE (very tired) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Treatment details included Antihistamine.
Information has been received from a Doctor of Pharmacy concerning a 66 year old female patient with no pertinent medical history or drug reactions/allergies, who on 04-NOV-2010 was vaccinated subcutaneously with a 0.65 ml single dose of ZOSTAVAX (Merck) (lot # 664670/0151Z). There was no concomitant medication. Within a few hours following vaccination, the patient experienced a rash on her torso and at the injection site. On 05-NOV-2010, the patient visited her physician's practice and was diagnosed with shingles. At the time of the report, the patient was recovering. No laboratory diagnostics studies were performed. Follow up information was received from the physician who reported that they were not involved in any way. Follow up information has been received from the physician. It was reported that the patient experienced an outbreak of shingles 4-5 hours after receiving ZOSTAVAX (Merck). The physician reported that it was unlikely to be related. At the time of the report the patient had not recovered. There were no laboratory studies performed. Shingles was considered to be an other important medical event by the physician. Additional information has been requested.
Information has been received from a nurse practitioner concerning a 20 year old female patient with depression and anxiety disorder, and VICODIN allergy and a history of pregnancy, who on an unspecified date was vaccinated with the complete series of GARDASIL (Lots# not reported). The nurse practitioner stated that on an unspecified time in the past, the patient had since developed a seizure disorder and was ongoing abdominal pain. The patient was evaluated at an unspecified emergency room at some unspecified time in the past and was seen by a neurologist. At the time of the report, the patient had not recovered. Upon internal review, seizure disorder was determined to be an other important medical event. Additional information has been requested.
I experienced extreme sore throat, fatigue and I got a stomach bug shortly after with nausea, vomiting.
Information has been received from a physician concerning a 14 year old male with a history of contact dermatitis from neomycin who last week was vaccinated with a first does of VARIVAX (Merck). There was no concomitant medication. One hour after receiving the VARIVAX (Merck) dose the patient developed a large hive at the injection site. No laboratories studies performed. The patient sought medical attention through an office visit. The physician was unaware if any treatment required, but was able to relay that the patient fully recovered. Additional information is not expected.
Breakthrough COVID 19 case.; Breakthrough COVID 19 case.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A child male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1 (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Jan2022, outcome "unknown" and all described as "Breakthrough COVID 19 case." It was unknown if therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt was found to have flacid left side with left sided facial droop with drooling, became unresponsive,  at approximately 10 am 1/17/2022, MD updated, Pt sent to ER for eval. ADMITTED WITH ACUTE CEREBRAL INFARCT. RETURNED TO FACILITY ON 1/20/22 COMFORT MEASURES ONLY AND ON HOSPICE. PASSED AWAY ON 1/28/22