chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE/PQC reported; Caller reported vaccines administered after temperature excursion; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions, or allergies were not reported.  On 13-JUL-2021, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) injection, at a dose of 0.5 milliliter (ml), administered intramuscularly (lot number T013727, expiration date 21-APR-2022) and hepatitis a vaccine, inactivated (VAQTA) injection, at a dose of 0.5 ml, administered intramuscularly (lot number T035720, expiration date 15-APR-2022) (strengths, vaccination schemes and anatomical sites of vaccination were not reported), both therapies as prophylaxis, that experienced a temperature excursion (product storage error). No additional adverse event (AE) reported.  The vaccines experienced a temperature excursion of 9.6 degrees Celsius (C) in 11 minutes, as recorded by a data logger. There was no previous temperature excursion. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.  devicelotnumber: T035720; expirationdate: 15-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; reportability: No; reprationale: Case information does not meet criteria for reportability
This was her 3rd or 4th dose of PREVNAR. She got the injection in the morning, and by evening her thigh was noticeably swollen, even though pants. It was warm to the touch, and very tender to the point she wasn't putting full weight when standing or walking. Two days later her walking seems normal, but it is still pretty swollen. Might have gone down a little. I also noticed red splotches on her thigh (not at the injection site) on the evening of day two. Still there the morning of day three.
Within minutes of leaving the pharmacy, I had a rininging in my ears.  Followed by a tingling feeling of my lips, tongue, neck and side of my face.  At the same time, my chest felt heavy/tight, and I was having difficulty breathing.  I returned to the pharmacy, where the kind and knowledgeable Pharmacist kept a close watch over me.  I had severe chills and shaking, then a few minutes of heat followed by chills. Also, a bitter/medicinal taste in my mouth.  My husband attempted to reach my Doctor, at the recommendation of the Pharmacist.  As it was a Saturday, my Doctor was not in.  The on-call Doctor recommended that I spend the weekend resting.  The Pharmacist keptxwatch over me,  until he felt that I was OK to leave.  However, he strongly urged me to follow-up with my Doctor on Monday and have her check my heart and vitals.  If my condition worsened, I was to go to the emergency room.
Fever (Highest 100.0) lasting from about 7:45am-10pm on 2/2 Joint pain (especially Hips, ankles, left elbow, left wrist, left hand) 7:45am-3:30am (2/2-2/3) Weakness 7:45am-6am (2/2-2/3) Tiredness 7:45am-6am (2/2-2/3) Large red hot lump approx 2 inches below injection site -Still present
Whole arm pain, hard to move for one day swollen hot for two days welts and rash and itchiness for several weeks on upper arm immediate stomach pain, indigestion at first then after several days nausea and dizziness wet stools period came two days early  very light and ended two days early significant breast pain and engorgement of breasts (lasted before and after period) symptoms lasted more than two weeks, every two days a new symptom would manifest No treatment administered; although my doctor did say to take pepcid and benedryl
Tel. call 6/23/11 from mother, asking advice for fever and rash. Fever of 104 degrees F on 6/20 with generalized, diffuse ash on 6/21. Parent used antipyretic for fever and EPSOM bath for rash. Advised physician vs. for diagnosis and treatment, but parent stated, "Not worried... he is better".
2days after second dose I broke out into a extremely itchy rash over most of my body; This is a spontaneous report from a contactable Consumer. This consumer reported for self that the 65-year-old female patient received second dose of bnt162b2 (BNT162B2, COVID 19, brand Pfizer), via an unspecified route of administration from 16Feb2021 14:00 on left arm at single dose for covid-19 immunization.  Medical history included Chemo for breast cancer 6 years ago. Concomitant medication included metoprolol (METOPROLOL) ER100mg, vitamin d3 (VITAMIN D3), vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) and multi vitamin. The patient previously took first dose of bnt162b2 (COVID 19, brand Pfizer) on 26Jan2021 03:00 PM, on Left arm for covid-19 immunization. No reaction with first dose. The patient experienced "2days after second dose i broke out into a extremely itchy rash over most of my body" (medically significant) on 18Feb2021 20:00 with outcome of not recovered.  The patient underwent lab tests and procedures which included white blood cell count: remains low on unknown date. Therapeutic measures were taken as a result of 2days after second dose i broke out into a extremely itchy rash over most of my body (rash). She is not pregnant. No other vaccine in four weeks. Treatment received. "Claritin helps a little but it is not subsiding. It's been four days since I had the shot". No covid prior vaccination. No covid tested post vaccination. None known allergies.
This case was reported by a other health professional via sales rep and described the occurrence of injection site rash in a adult male patient who received SHINGRIX. On 16th April 2018, the patient received the 1st dose of SHINGIRX. On an unknown date, the outcome of the injection site rash was unknown. The reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a clinical study coordinator. The age at vaccination was not reported. The reporter felt that the patient experienced herpes type rash at injection site. The reporter was wondering if the 2nd dose should be administered. The reporter felt that the product created reaction.
Fully vaccinated, not boosted.   COVID infection breakthrough.   Inpatient hospital stay on a general medical unit.
Injection site began to itch and develop red rash.  Now is a large red circle about 3? in circumference.  Slightly tender and itchy.
Narrative: Patient received his first COVID vaccine on 1/5/21. On 1/21/21 he had a telephone visit with his pharmacist provider and reports experiencing chills, fever, joint pains, extreme fatigue/tiredness and confusion. Symptoms were severe per patient report, "all I could do was just lay in bed: and lasted x 3 days. No known prior COVID infection. Patient refused the 2nd dose.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On 10-JUN-2015, the patient was vaccinated with improperly stored MMR II lot # J014872 and 21-NOV-2015 (unknown strength and route). Concomitant medications were not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine lot and arm site  not recorded.  Patient reports he experienced throat pruritis, cough, expiratory wheeze and more nonspecifically 'didn't feel right.'  He does not recall oral/facial/tongue or throat swelling, flushing, urticaria, other site pruritis, watery eyes, burning ears, chest pain or n/v/d. Onset was about 30 minutes. He did not seek medical care. He did not received any medically supervised or self administered treatment (e,g, benadryl). The symptoms resolved without further intervention or repeat event.
Pt admit 4/8/21 2' suspected TIA or stroke vs seizure disorder. Encephalitis (MRI+) post-Moderna COVID-19 Vaccine 2nd dose 3/8/21. Started on IVIG x5 doses and prednisone, along with seizure meds for tx. Temporary pacemaker placed 4/13 (HR=32). Pt with improved mentation post-tx and sx. Discharged home stable 4/19.
very very painful and sore; very very painful and sore; This is a spontaneous report received from a contactable reporter (Consumer or other non-HCP) from medical information team. The reporter is the patient.  A 79-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 14:00 as dose 3 (booster), single (Lot number: GH9702) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Heart attack" (unspecified if ongoing), notes: Heart attack about 6 weeks ago; "Pacemaker" (unspecified if ongoing), notes: he got 5 weeks ago. Concomitant medication(s) included: ELIQUIS taken for anticoagulant therapy; METOPROLOL taken for anticoagulant therapy, stop date: 19Oct2022 at 00:09; FLU [INFLUENZA VACCINE] taken for immunisation. Vaccination history included: Bnt162b2 (DOSE 1; lot number: unknown), for COVID-19 Immunization; Bnt162b2 (DOSE 2; lot number unknown), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 18Oct2022, outcome "not recovered" and all described as "very very painful and sore". Therapeutic measures were not taken as a result of vaccination site pain, pain in extremity. Clinical course was as follows: The reporter/patient stated that he received Pfizer covid-19 bivalent booster shot yesterday (18Oct2022) and his arm is "very very painful and sore". The patient had the Pfizer Covid Bivalent Booster at 2 in the afternoon (on 18Oct022). He is in a lot of pain and has soreness where they gave the needle in the left arm. The patient asked if this is common and how long his pain on his arm would last. He is still experiencing this now, that is why he is calling, has stayed the same without treatment. The patient has 2 medicines he is taking for blood thinners. Is that going to affect him? When clarifying that both Eliquis and Metoprolol were being taken as blood thinner, but he is not quite sure and believes it they are (taken) for blood thinners. The patient also asked if Eliquis (2x a day) and metoprolol tartrate (reported as a non-Pfizer product) has an interaction with Pfizer covid-19 bivalent booster shot? He was on a blood thinner and stopped taking it because he is afraid, because he took the booster. Prior Vaccinations (within 4 weeks): "2 or 3 weeks ago, had flu shot." The patient also stated that he got a heart device "pacemaker" 5 weeks ago, had heart back about 6 weeks ago. When he came out of hospital, they told him to take this (Eliquis). He also clarified that he stopped taking this medication and did not take it today because he is concerned; and that he stopped taking the Metoprolol today, as well. Since he has a pacemaker, he wanted to know if that is okay with the vaccine.
Arm pain, itchy, hard and  big red splotches on right arm over injection site
14OCT low grade fever 1wk;lump  upper jaw bone rt side;15OCT behind neck, ear rt-rt side swollen;painful when touched;
crying w/some high pitched tone approx 3-4hr;some body jerking;t99.9;
Patient was presented to ER with fever of 102 degrees F, was given TYLENOL. Patient left ER AMA and followed up with us at Clinic and fever had come down to 100 degrees F, CBC and Xray were WNL, No signs of distress. Flu and RSV tests were negative.
This spontaneous report as received from a certified medical assistant refers to a multiple patients of unknown age and gender. No pertinent medical history or concomitant medications were reported. On multiple unspecified dates, multiple unspecified patients were vaccinated with improperly stored PNEUMOVAX23, lot # L031459 with expiration date 30-APR-2017 and lot # M005286 with expiration date 08-OCT-2017 (dose and route of administration not provided). The vaccine products were exposed to the following conditions: temperature 0.3 degrees Celsius for 8 hours. There was no previous temperature excursion. The temperature excursion was captured via a Digital Data Logger. This is one of several reports received from the same reporter. Additional information has been requested.
I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 1/25/2022 CANCER METASTATIC TO RIGHT LUNG I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 1/7/2022 CANCER METASTATIC TO RIGHT LUNG J96.00 ACUTE RESPIRATORY FAILURE 1/7/2022 CANCER METASTATIC TO RIGHT LUNG J96.10 CHRONIC RESPIRATORY FAILURE 1/19/2022 CANCER METASTATIC TO RIGHT LUNG J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/30/2022 CANCER METASTATIC TO RIGHT LUNG R09.02 HYPOXIA 5/12/2022 CANCER METASTATIC TO RIGHT LUNG I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 1/25/2022 CANCER METASTATIC TO RIGHT LUNG I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 1/7/2022 CANCER METASTATIC TO RIGHT LUNG J96.00 ACUTE RESPIRATORY FAILURE 1/7/2022 CANCER METASTATIC TO RIGHT LUNG J96.10 CHRONIC RESPIRATORY FAILURE 1/19/2022 CANCER METASTATIC TO RIGHT LUNG J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/30/2022 CANCER METASTATIC TO RIGHT LUNG R09.02 HYPOXIA 5/12/2022 CANCER METASTATIC TO RIGHT LUNG I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 1/25/2022 HYPERCALCEMIA I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 1/7/2022 HYPERCALCEMIA J96.00 ACUTE RESPIRATORY FAILURE 1/7/2022 HYPERCALCEMIA J96.10 CHRONIC RESPIRATORY FAILURE 1/19/2022 HYPERCALCEMIA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/30/2022 HYPERCALCEMIA R09.02 HYPOXIA 5/12/2022 HYPERCALCEMIA I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 1/25/2022 DIARRHEA I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 1/7/2022 DIARRHEA J96.00 ACUTE RESPIRATORY FAILURE 1/7/2022 DIARRHEA J96.10 CHRONIC RESPIRATORY FAILURE 1/19/2022 DIARRHEA J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/30/2022 DIARRHEA R09.02 HYPOXIA 5/12/2022 DIARRHEA I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 1/25/2022 HEMOPTYSIS I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 1/7/2022 HEMOPTYSIS J96.00 ACUTE RESPIRATORY FAILURE 1/7/2022 HEMOPTYSIS J96.10 CHRONIC RESPIRATORY FAILURE 1/19/2022 HEMOPTYSIS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/30/2022 HEMOPTYSIS R09.02 HYPOXIA 5/12/2022 HEMOPTYSIS I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 1/25/2022 C DIFFICILE INFECTION I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 1/7/2022 C DIFFICILE INFECTION J96.00 ACUTE RESPIRATORY FAILURE 1/7/2022 C DIFFICILE INFECTION J96.10 CHRONIC RESPIRATORY FAILURE 1/19/2022 C DIFFICILE INFECTION J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/30/2022 C DIFFICILE INFECTION R09.02 HYPOXIA 5/12/2022 C DIFFICILE INFECTION I26.99 PULMONARY EMBOLISM, UNSPECIFIED. 1/25/2022 LUNG MASS I82.402 ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 1/7/2022 LUNG MASS J96.00 ACUTE RESPIRATORY FAILURE 1/7/2022 LUNG MASS J96.10 CHRONIC RESPIRATORY FAILURE 1/19/2022 LUNG MASS J96.11 CHRONIC HYPOXEMIC RESPIRATORY FAILURE 7/30/2022 LUNG MASS R09.02 HYPOXIA 5/12/2022 LUNG MASS
Panic attack ~20min after receiving the vaccine. Nightmare the night after getting the vaccine. Trouble sleeping the past ~3 nights since receiving the vaccine.
but the medical assistant "hit a spot lower and hit a blood vessel". There were "a couple of drops of blood when the needle was pulled out, and a large marble-sized hematoma formed"; but the medical assistant "hit a spot lower and hit a blood vessel". There were "a couple of drops of blood when the needle was pulled out, and a large marble-sized hematoma formed"; This is a spontaneous report from a contactable hospital pharmacist via Medical Information Team. A 34-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as a Dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The pharmacist mentioned that a patient received the second dose of the Pfizer-BioNTech COVID-19 Vaccine but the medical assistant "hit a spot lower and hit a blood vessel". There were "a couple of drops of blood when the needle was pulled out, and a large marble-sized hematoma formed". Pharmacist was asking if this would affect the efficacy or the mechanism of the vaccine and if the patient need to be revaccinated. The outcome of events was unknown.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information was expected.
Patient describes severe muscle pain and aches for 3 to 4 days after receiving vaccinations. Pain was constant and worse after the first shot. Patient tried OTC pan relievers with no relief. Pain went away after 5 days.
MILD ACHES, arthralgia , LOW GRADE FEVER, BILATERAL FEET PAIN, SWELLING
pt recv vax 14DEC95 & pt devel tingling in arm & fingers which resolved by 15DEC95;14DEC95 pt also exp an intense deep IM pain @ the inj site when moved arm;15DEC95 devel swollen & sl warm shoulder;pt med records noted an allergy to pneumo
Tested positive for COVID-19 on July 17. Slight headache, body aches, coughing and drainage. Prescribed Paxlovid on July 18.
It was discovered after the administration of the vaccine was given to Trenton when he was 17 years and 4 months old.  He did not experience any side effects due to the vaccine other than a sore arm.  After consulting the CDC Covid-19 Vaccine Administration Errors and Deviations we told the patient we would administer the 2nd dose to complete the series.
weakness in the knees; developed fluttering in the chest; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar event for two patients (herself and husband). This is the first of two reports.   A female patient of an unspecified age (reported as 63,  no unit) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Mar2021 as a SINGLE DOSE for covid-19 immunisation. Medical history included high blood pressure, high cholesterol, aterial stenosis, chronic kidney disease, and diabetes. The patient's concomitant medications were not reported. On 11Mar2021, during the initial 15 minutes she had no side effect or sore arm, but on the drive home which was approximately 30 miles, both she and her husband developed fluttering in the chest and then it went away. She felt okay that Friday, Saturday, and Sunday. Then Tuesday (16Mar2021) she developed fluttering in the chest and weakness in the knees. She called her PCP, and they did an EKG and that came back good. Then she went to the ER Saturday night (20Mar2021), received a drip, heart monitor and the doctor said everything looked okay. She was scheduled to see a heart doctor this upcoming Wednesday. The outcome of the events was unknown.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : 2021314633 same report/drug, similar event, different patient.
The usual initial symptoms started around 12 hours after injection; severe flu like symptoms, chills, joint/muscle aches, headache. I get those all after every Moderna injection. This was my 2nd booster. I had severe peripheral tremors after my hospitalization with COVID in November 2020 but they were improving significantly. They did not return/worsen after any of the previous 3 vaccinations I received. Three days after this injection, most flu symptoms were subsiding or gone but I started having trouble with my tremors worsening. By Monday (5 days) they were severe, similar to what I had immediately after my hospitalization so I sealed medical attention.
experienced pain in left arm; shoulder  pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (experienced pain in left arm) and ARTHRALGIA (  shoulder  pain) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 004m20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included MELOXICAM (MOBIC), AMOXICILLIN TRIHYDRATE, CLARITHROMYCIN, ESOMEPRAZOLE MAGNESIUM (NEXIUM 1-2-3), ESTRADIOL (ESTROGEN), VITAMIN D NOS, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP), FISH OIL and CENTRUM SILVER +50 for an unknown indication.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 31-Jan-2021, the patient experienced ARTHRALGIA (  shoulder  pain). On 28-Feb-2021, the patient experienced PAIN IN EXTREMITY (experienced pain in left arm). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (experienced pain in left arm) and ARTHRALGIA (  shoulder  pain) outcome was unknown.
Right leg swelling, soreness, pain  treatment ice, rest, over the counter motrin and benadryl
she tested positive 03Sep; she tested positive 03Sep; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 62-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 30Nov2022 as dose 5 (booster), single (Lot number: GJ5342) at the age of 61 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 05Mar2021 as dose 1, single (Lot number: EN6204, Expiration Date: 30Jun2021), on 26Mar2021 as dose 2, single (Lot number: EN6208), on 25Oct2021 as dose 3 (booster), single (Lot number: FF8839, Expiration Date: 22Nov2021) and on 19Jul2022 as dose 4 (booster), single (Lot number: FJ9943) for covid-19 immunisation. The patient's relevant medical history included: "Caller mentioned that she has Lupos", start date: 2013 (ongoing); "her white blood count is down to 2.6" (unspecified if ongoing), notes: her white blood count is down to 2.6; "Caller is immunocompromised." (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 03Sep2023, outcome "unknown" and all described as "she tested positive 03Sep". Clinical course details: The patient (the caller) stated that her husband had a Moderna Covid 19 vaccine and she had the Pfizer Covid 19 vaccine (caller referring to vaccination in the past). She stated that her husband tested positive for Covid on September 1st, and she tested positive on September 3rd, they already took Paxlovid and had a mild case of Covid. Immediately after testing positive, her husband took Paxlovid and 03Sep she tested positive for Covid, she reached out to her rheumatologist and was recommended to take Paxlovid as well which she did. As it was such a mild case of Covid, she was afraid that she will get it again so she was asking how soon she can get the newest Pfizer Covid 19 vaccine (verified 2023-2024 formula) as they are getting ready to go on a trip. At this point, she stated that she had lupus, her white blood count is down to 2.6, which per the patient is always very low. She was also asking if they can get the latest Pfizer Covid19 booster as she was googling the information, she was getting conflicting information. Some info says to wait 90 days, some says to wait 2 weeks. She stated that she started taking Paxlovid on 03Sep and still has barely a cough that could be a cold. Per the patient, she never got a bad cough, she barely felt sick, it was such a mild case per the patient. She has gotten sicker after a Mexican meal, asking when she can get the Pfizer Covid 19 vaccines and if she should wait. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Negative; (unspecified date) Positive; (03Sep2023) Positive; White blood cell count: (unspecified date) 2.6, notes: her white blood count is down to 2.6 - per caller is always very low. Therapeutic measures were taken as a result of drug ineffective, covid-19.