chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information on patients medical history or concurrent conditions was provided. On an unknown dates, the patients were vaccinated with an unspecified number of improperly stored doses of ROTATEQ oral liquid (strength, dose, lot# and expiration date were not reported). No information on patients concomitant medications was provided. No adverse effects were reported. Product quality complaint (PQC) was not involved. This is one of several reports from the same reporter. Additional information has been requested.
after 2 hours headache lasted for 3-4 hours; left arm injection site soreness worse at night unable to raise arm due to pain lasted up to 48 hours from time of injection; unable to raise arm due to pain; This is a spontaneous report from a contactable other hcp (patient). A 64-year-old male patient received bnt162b2 (Lot: EK5730), via an unspecified route of administration at Left arm, first dose on 20Dec2020 10:30 at single dose, for COVID-19 immunization. Medical history included diabetes, high cholesterol and hypertension (HTN) from an unknown date. Prior to vaccination, the patient was not diagnosed with COVID-19. No Known allergies. Concomitant medication included metformine, lisinopril, atorvastatin and finasteride. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that after 2 hours headache lasted for 3-4 hours left arm injection site soreness worse at night unable to raise arm due to pain lasted up to 48 hours from time of injection. The adverse event start on 20Dec2020, at 12:15 PM. The events are reported as non-serious. Therapeutic measures were taken as a result of after 2 hours headache lasted for 3-4 hours left arm injection site soreness worse at night unable to raise arm due to pain lasted up to 48 hours from time of injection, treatment included ibuprofen. The outcome of the event was recovering.
Left arm site of vaccine, swelling, hard, red, tight; Left arm site of vaccine, swelling, hard, red, tight; Left arm site of vaccine, swelling, hard, red, tight; Left arm site of vaccine, swelling, hard, red, tight; perhaps some shortness of breathe; fevers; This is a spontaneous report received from a contactable reporter(s) (Nurse) from medical information team.  A female patient received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Batch/Lot number: unknown), in left arm for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE DISCOMFORT (non-serious), outcome "not recovered" and all described as "Left arm site of vaccine, swelling, hard, red, tight"; VACCINATION SITE INDURATION (non-serious), VACCINATION SITE ERYTHEMA (non-serious), outcome "unknown" and all described as "Left arm site of vaccine, swelling, hard, red, tight"; DYSPNOEA (non-serious), outcome "unknown", described as "perhaps some shortness of breathe"; PYREXIA (non-serious), outcome "unknown", described as "fevers".  Additional information:  The caller provided the local reactions that were experienced with 2 patients and wanted to know if these were typical. This is the case for the other lady with Left arm site of vaccine, swelling, hard, red, tight, perhaps some shortness of breath no wheezing, no cough, fevers, continue to grow 9 days later/ get bigger. The Lot numbers were reported as GM9410 expiration 31Aug2024 and GN1897 expiration 31Aug2024.  The information on the batch/lot number for pneumococcal 20-val conj vac (dipht CRM197 protein) has been requested and will be submitted if and when received.
DVT in the leg. Patient went to ER and put on XARELTO for treatment.
Upon arrival to the ED, the patient reported symptoms starting on Sunday with exertional SOB. SOB was significant while laying flat and awakening at night SOB. Patient was admitted to the hospital and stayed in the ICU for a few days.  Medications received during the patients stay included: APAP 650 mg, ASA 81 mg, Atorvastatin 40 mg, Colchicine 0.6 mg, diphenhydramine, enoxaparin 40 mg, fentanyl citrate, heparin. lidocaine hcl, metoprolol tartrate, midazolam hcl, ondansetron, miralax and NS. The patient was admitted 6/4/21 and discharged 6/10/21.
Hives all over body about 80% of the entire body. Swollen face, tongue and throat felt compressed. Started exactly 24hours after shot and lasted 4 days. On the 2nd day of the symptoms is when my face and tongue became swollen and my throat felt like there was an arm around it.
Sedation, Phlebitis, NauseaVomiting, DIFFICULTY CATCHING BREATH X7 DAYS POST VACCINE Narrative:
per pt, initial swelling, redness, tenderness around inj site objective observation by MD 20APR98 2.0cm red erythema, tender around inj site (pt afeb);
Claimed throat felt "tight" and felt short of breath.  Administered 25mg of liquid Diphenhydramine 10 minutes post injection.  Approximately 15 minutes after diphenhydramine administered, patient claimed throat was tightening more and breathing was difficult.  Administered 1 dose of Epipen and called 911.  Patient called approximately 45 minutes later and stated she was stable.
Many bruises on both legs with no prior history of easily bruising. Still present and not resolving.
2 1/2 inch red raised area warm to the touch, seen in office given 5 ml of benadryl
Sweat after second dose; Numb finger tips after second dose; Chills after second dose; Fever after second dose; Headache after second dose; Nausea after second dose; Body aches after second dose; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPERHIDROSIS (Sweat after second dose), HYPOAESTHESIA (Numb finger tips after second dose), CHILLS (Chills after second dose), PYREXIA (Fever after second dose) and HEADACHE (Headache after second dose) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced HYPERHIDROSIS (Sweat after second dose), HYPOAESTHESIA (Numb finger tips after second dose), CHILLS (Chills after second dose), PYREXIA (Fever after second dose), HEADACHE (Headache after second dose), NAUSEA (Nausea after second dose) and MYALGIA (Body aches after second dose). The patient was treated with PREGNAZON at a dose of 20 mg once a day. At the time of the report, HYPERHIDROSIS (Sweat after second dose), HYPOAESTHESIA (Numb finger tips after second dose), CHILLS (Chills after second dose), PYREXIA (Fever after second dose), NAUSEA (Nausea after second dose) and MYALGIA (Body aches after second dose) outcome was unknown and HEADACHE (Headache after second dose) had not resolved.            Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications information was reported. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments
Shortly after being given the vaccine the person had an episode of near-syncope where she felt light-headed and was not feeling well.  She has had a history of this occurring in the past after an injection before (unknown if vaccination or other IM injection) and blood draws.  She did not have any loss of conscious, but she became pale and diaphoretic and felt like she could pass out if she would stand consistent with a vasovagal event.  She initially had an elevated pulse at 113 which came down to 65 and her blood pressure was initially 110/60 and then 98/62 on recheck.  Patient was placed supine on a cot and then her legs were elevated to help her symptoms.  She did have some improvement in her symptoms prior to transport to the ER via EMS at her request.
patient felt Tingley  at 15 minutes wait 10 more minutes the stated he felt fine
Received shot 02/04/2021, sudden Cardiac Arrest 2/8/2021, found 2/10/2021
shoulder and neck stiffness, unable to turn his head x 2 1/2 days since vaccination
prolonged crying/screaming x 10hr beginning 3hr p/vax;fever to 101 lasting 36hr;irritable/grumpy x 3 days;no increase in pre-existing faint rash on nasal or resp congestion;
This spontaneous report as received from a nurse refers to a patient of unknown age. No information about medical history, drug reactions and allergies was specified. Nurse reported that an expired dose of (Oka/Merck) PROQUAD was administered to a patient on 30-JUL-2014 (lot # H020851, expiry date 26-MAY-2014, dose 0.5 milliliter (ml) subcutaneous). No concomitant medications were reported. No adverse effects reported. Additional information has been requested.
Severe fatigue, body aches, chills, nausea, headache, decreased appetite.
pt recvd vax 11MAR93 & devel t103 (10 hrs p/vax), erythema;
pt recvd Fluogen vax but was supossed to recvd 1993 fluogen vax instead got 1992 fluogen vax; This case is one of 3 who recvd inadvertent administration of the 1992 flu vax;
Sick for 5 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Sick for 5 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Mar-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 ILLNESS (Sick for 5 days). At the time of the report, ILLNESS (Sick for 5 days) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
03/15/2021: Presented to the emergency department with general malaise, polydipsia, polyuria, and dizziness. The patient was found to have blood glucoses in the 500s and a hemoglobin A1C of 12. The patient was admitted and improved with metformin, long acting and short acting insulin.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 16Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Rheumatoid arthritis but I've not been on any medication's for it since Sep2022" (unspecified if ongoing), notes: Rheumatoid arthritis but I've not been on any medication's for it since Sep2022; "immunocompromised" (ongoing), notes: I'm immunocompromised. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose number unknown, single; unknown manufacturer, Patient previously receive a COVID-19 Vaccine: Yes), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient received Paxlovid treatment on 17Jan2023 and stop on 21Jan2023. Patient was not taking any other medications/products within 2 weeks of starting COVID-19 treatment. Patient previously received a COVID-19 Vaccine. Other medications in two weeks was no. Patient took paxlovid to treat a COVID-19 infection because I'm immunocompromised   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including pharmacokinetics, severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Systemic urticaria x 1.5 months, better with prednisone taper but persisted afterwards. Patient taking Cetirizine but not helping after prednisone taper as urticaria has returned.
Pt's R arm became red, swollen, feverish. Pt had sx of N/D/V, HA. Adv. pt to use ice packs, force fluids, rotate Tylenol and Motrin q 4 h.
metallic taste in his mouth/ continues to have this taste; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  A male patient received BNT162b2 (COMIRNATY), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DYSGEUSIA (non-serious), 24 hrs after the suspect product(s) administration, outcome "not recovered", described as "metallic taste in his mouth/ continues to have this taste".  Additional Information: The patient experienced a metallic taste in his mouth 24 hours post dose and continued to have that taste. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a physician, via a company representative, refers to a female patient of unknown age. No information on her medical history, concurrent conditions or concomitant drugs was provided. On an unknown date, the patient was vaccinated with the second dose of GARDASIL 9 (route and site of vaccination, lot# and expiration date not reported). On an unknown date, the patient experienced headaches for one week. She did not seek medical attention. The outcome of headaches was unknown. The reporting physician did not assess the causal relationship between the event of headaches and vaccination with GARDASIL 9. Additional information has been requested.
This spontaneous report has been received from a 71 year old female consumer reporting on herself. The patient's medical history included heart attack, breast cancer and atrial fibrillation, apart from this drug allergies included sulfa drugs, latex and PERCOCET. Approximately in 2012 (reported as 3-4 years ago), the patient was vaccinated with ZOSTAVAX, injection, subcutaneously, one dose (anatomical location, lot#, and expiration date were not provided). The patient was taking "loads" of concomitant medications. It was stated by the reporter, that on an unknown date in 2016, she received an LINQ (implantable cardiac monitor insertion) implant in her chest. Then, in approximately July 2016 (reported as "almost a month ago"), the patient experienced shingles like symptoms, from her belly button to her left abdomen, there was pain an pinching and also the area was "puffed out" (swelling). The patient reported that she received the vaccine at a supermarket, she did not know information about the physician, and she did not received any treatment. On an unknown date the patient performed a ultrasound but did not find anything and also she sought medical attention. No product quality complaint was involved. The outcome of implantable cardiac monitor insertion was unknown. The outcome of herpes zoster, swelling and pain of skin was reported as not recovered. Upon internal review implantable cardiac monitor insertion was determined to be medically significant. The relatedness between the events and ZOSTAVAX, was not reported. Additional information has been requested.
Woke up at 3:45 am 2/27/2021 with 101.0 fever.  Took 1000mg Tylenol.  Fever went back to normal.  At 7:00 pm that evening temp increased to 100.0.  Took 1000mg Tylenol.  At 3:00am rechecked temp, was normal.  No further spikes in temperature.
sore left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN, CARVEDILOL, OMEPRAZOLE, TELMISARTAN (MICARDIS), ATORVASTATIN, CELECOXIB (CELEBREX), ACETYLSALICYLIC ACID (ASPIRIN 81), IRON, MAGNESIUM, VITAMIN C [ASCORBIC ACID], INSULIN GLARGINE (LANTUS) and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). At the time of the report, VACCINATION SITE PAIN (sore left injection site arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: normal (normal) normal.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   concomitant medication include Novolog Insulin No treatment medication use was reported.   This case was linked to MOD-2021-350530 (Patient Link).; Sender's Comments: This case concerns a 72 year-old male patient with no reported medical history, who experienced the expected non-serious event of Vaccination site pain. The event occurred on the same day as the first dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The spontaneous report indicated Medically significant seriousness criteria, but based on medical judgement and review of source document that did not include information supporting the seriousness criteria manual override was done to remove seriousness criteria.
Patient with prior bronchiolitis / RAD: seen after resolution of pulmonary symptoms, received flu vaccine, began wheezing that night, confirmed to wheeze, seen in ER 11/8
10/7 IMMEDIATE REDNESS AT SITE, 10/9 SWELLING REDNESS AND WARMTH, 10/10 WENT TO CLINIC LESION MEASURED AT 10 INCHES, GIVEN METHYLPREDNISOLONE PACK 10/12 SWELLING REACHED ELBOW, 10/14 SWELLING SUBSIDED.
Sharp, stabbing, intermittent head pain - 12 of 10 on pain scale, left side of head. Located in same spot each time. Occurring 8-10 an hr.
I had bloody diarrhea 6 out of the first 7 days after being vaccinated. Low grade fever the first morning only but stomach pain and discomfort for 9 days and felt faint when in a store on day 8. I have never had bloody diarrhea for more than 1 day ever. I do have a lot of medical conditions that require me to take a lot of medication and this may have contributed to it.
Low grade fever first two days, then a near syncope episode on Tuesday night, sweating, clammy and nausea resulting in an ER visit. Since then I've been lightheaded, had sinus trouble, areas of cold and buzzing feelings which have traveled from my limbs to my back and to my head. Loss of appetite and increased feelings of anxiety. Muscle weakness and occasional loose stool.
This case was reported by a nurse and described a female pt who experienced hair loss following immunization with hepatitis B vaccine (manufacturer unknown).  Family history was significant for hair loss in the pt's sister following receipt of hepatitis B vaccine.  On unspecified dates, the pt received an unspecified number of doses of hepatitis B vaccine (manufacturer unknown).  Subsequently, on an unspecified date, the pt experienced hair loss.
Information has been received from a nurse concerning an adult pt who was vaccinated with MMR II vaccine "probably as a child." Subsequently the pt was "equivocal on her testing for rubella," failed to seroconvert fully. Additional info has been requested.
Information has been received from a health professional concerning a 16 year old male who on 11-AUG-2000 was vaccinated with a first subcutaneous dose in the right arm of varicella virus vaccine live (Oka/Merck) (lot#623616/168/88J). There was no illness at the time of vaccination. It was noted that "two weeks prior" in November 2005, the patient's father had shingles. On 07-DEC-2005 the patient experienced a varicella infection with rash and fever. Subsequently, the patient recovered. Additional information is not expected.
Syringe and needle separated; Liquid leaking out between syringe and needle; This spontaneous case was reported by a pharmacist and describes the occurrence of DEVICE CONNECTION ISSUE (Syringe and needle separated) and UNDERDOSE (Liquid leaking out between syringe and needle) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (Patient had had COVID-19 90 days prior to vaccination.). Concurrent medical conditions included Penicillin allergy, Hypertension and Hypothyroidism. Concomitant products included LISINOPRIL and CARVEDILOL for Hypertension, LEVOTHYROXINE for Hypothyroidism.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced DEVICE CONNECTION ISSUE (Syringe and needle separated) and UNDERDOSE (Liquid leaking out between syringe and needle). On 03-Feb-2021, DEVICE CONNECTION ISSUE (Syringe and needle separated) and UNDERDOSE (Liquid leaking out between syringe and needle) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: No new information was updated. On 14-Jun-2021: No new information updated.
I received the vaccine on a Saturday evening and by Sunday morning, I was sick as a dog with flu like symptoms - massive headache, terrible backache (like someone kicked me in the back), chills and fever.   Sunday evening in the middle of the night, in bed, I was shaking so badly from chills that I was afraid to get up to get Tylenol.  I finally did and I couldn't even focus my eyesight and control my hands as I went to open the bottle of pills that my hands were shaking so badly that I spilled them all over the place.   Finally I woke my husband who heated up blankets in the dryer and brought me hot tea.  My husband helped me to the bathroom where I vomited.  I cannot remember when I was so sick.  I missed work that day at my part-time job and the next day at my full time job as a teacher.
No AE/no side effects; Nurse called and reported that an expired dose of PNEUMOVAX 23 was administered to a patient.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 11-OCT-2023, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, 1 dose, lot #W021636, expiration date: 01-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided) (Expired product administered). The patient did not experienced side effects.
9/19/13 swelling, redness, warm to touch, 48 hours after vaccine administered. Recommended cold compresses and ibuprofen and return for reassessment in 24 hours. Called mother 9/20/13 - swelling, redness and hot to touch "almost completely gone".