chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to multiple patients of unknown demographics. On unknown dates the patients received improperly stored doses of RECOMBIVAX HB (lot # reported as M018625 with expiry date: 11-AUG-2018). The temperature and timeframe that the RECOMBIVAX HB was exposed to were as follows: Temperature: 50.4F. Timeframe: 19.5 hours total cumulative. The medical assistant reported that the patients received doses of improperly stored RECOMBIVAX HB but lot numbers and expiry dates of those specific vaccines that were administered was unknown. No adverse effects reported. Medical assistant also reported that the vaccines were not yet back in range. Data logger was involved. There were no previous excursions. The outcome was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 19 year old not pregnant female patient. Pharmacist reported that patient had titers drawn one month ago in August 2013 on an unspecified date and the patient was negative for hepatitis B immunity. Patient had received all doses in the series of an unspecified hepatitis B vaccine, could not rule out RECOMBIVAX HB (thimerosal status was not provided). Patient initially was administered hepatitis B vaccine series six years ago, in approximately 2007, on an unspecified date, (lot# unspecified) (dose, route and location unspecified). The outcome of event was not provided. Additional information has been requested.
This spontaneous report was received from a physician referring to a 5 month old patient of unknown gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On an unknown date, the patient was vaccinated with ROTATEQ per oral (dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis at 5 months. No adverse effect was reported.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 09-NOV-2015 the patient was vaccinated with ROTATEQ (lot # L008057, expiration date 01-DEC-2016, oral, dose not reported), which was exposed to temperatures outside of the recommended temperature. No adverse experience had been reported. This is one of several reports received from the same source. Additional information had been requested.
Having a few symptoms of the side effects past 2 days and not getting better; 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 VACCINATION COMPLICATION (Having a few symptoms of the side effects past 2 days and not getting better) 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. No concomitant medication was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Having a few symptoms of the side effects past 2 days and not getting better). At the time of the report, VACCINATION COMPLICATION (Having a few symptoms of the side effects past 2 days and not getting better) outcome was unknown.     Treatment medication was not provided.    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
pt recvd vax 11AUG93 & 17AUG93 pt exp a severe h/a, nausea, vomiting & malaise; MD dx h/a as fibrositis of the occipital tendons; No further details were provided;
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 031L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021 at 10:23 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 21-Mar-2021 at 10:41 AM, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On an unknown date, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 26.67.  Concomitant products were not provided.  On 14-Feb-2021, Excursion time was 09 AM, 10 AM, 11 AM, 2 PM and 3 PM, temperature was 32, 32, 32, 35 and 35, total doses given for the day was 162, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 09-Feb-2021, vial was moved to clinic on 13-Jan-2021. 30 vials were sent to clinic. Vaccine BUD date was 10-Mar-2021.  On 21-Mar-2021, Excursion time was 09 AM, 10 AM and 11 AM, temperature was 34, 32 and 34, total doses given for the day was 94, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 16-Mar-2021, vial was moved to clinic on 21-Mar-2021. 10 vials were sent to clinic. Vaccine BUD date was 15-Apr-2021.  On 21-Mar-2021, vials were stored in cooler 1, at following time and temperature respectively, 9 AM: 34, 10 AM: 32, 11 AM: 34, 12 AM: 43, 1PM: 40, 2 PM: 40, 3 PM: 41, 4 PM: 41 and 5 PM: 41.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
pt recv vax 925AM & 20 mins later no rxn but 45 min later started having abd discomfort & hurting all over; 155Pm went to ER went into shock w/swelling of hands & feet & ear lobes; adm to hosp; c/o aching all over & very weak;
This spontaneous report was received from a medical assistant refers to patient of unknown age and gender. On 31-JUL-2014, the patient were vaccinated with GARDASIL (0.5 ml, lot#J011272, expiration date: 21-APR-2016) intramuscularly which underwent a temperature excursion. No adverse events were reported. At the time of the report action taken with GARDASIL was unknown. This is one of several reports from the same source. Additional information has been requested.
lt arm inflamed from inject site down; upper & lower muscle pain; eruption from inject site; pain since OCT93; heat applied x-10x daily; loss of strength in hand & arm;
Pt developed a blotchy rash, non-elevated, within 24 hours of vaccination that lasted for 3 days. She had no fever or other illnesses.
Vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VERTIGO (Vertigo). The patient was treated with MECLOZINE HYDROCHLORIDE (MECLIZINE [MECLOZINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 27-May-2021, VERTIGO (Vertigo) was resolving.               Most recent FOLLOW-UP information incorporated above includes: On 09-Jun-2021: TCR contains No New Information.
Pt seen in clinic next day with large area of erythema, red, hot to touch and painful
This spontaneous report as received from a pharmacy technician refers to patient of unknown age and gender. Concurrent conditions and medical history were not reported. On 14-SEP-2016, the patient was vaccinated with an expired dose of M-M-R II (Lot# K020189, expiration date 11-SEP-2016) (Dose and route were not provided). Concomitant medications was not reported. The patient had not reported an adverse experience. Additional information has been requested.
Body aches and soreness in every joint.  Flu like symptoms with headache.  Intense itching, not unlike the smallpox vaccine.  Nausea and one episode of vomiting.  Took 2 800mg Motrins eight hours apart for the soreness and the next day the aches subsided.  Upset stomach lasted for three days after.  Could have been in tandem with bad food but whatever it was, seems like the shot exacerbated the symptoms.  This was my booster (7th shot) and I had never had any adverse reactions to the previous six shots except the standard lump under the skin.
Pt pale, pinpoint Pupils.NO SOB, in no acute distress.to RTC in 1 week for FU C PCP NP. Vs @ 1345 HR 126 Resp. 36 Repeated @ 1400. HR 130 RR 36 Temp 98 F SPO2 96% !410: Pt Dc home ED precautions and home care Instructions given. Parent V/U agree plan of care.
Swelling, hot to touch, tender to injection site. 24 hours post injection all symptoms and swelling spreading down left arm. Area was red and itchy.
pt recv vax 10FEB99 & redness began 12FEB;seen @ clinic 15FEB99 7x9cm area of redness & induration @ site & below;tx ice & DPH;
Patient received expired doses of the Moderna COVID19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired doses of the Moderna COVID19 vaccine) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059h21a) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired doses of the Moderna COVID19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired doses of the Moderna COVID19 vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant products were reported.  8 patients received expired doses of the Moderna COVID-19 vaccine. Patient received booster dose on 28Mar2022.  It was reported that vial did not undergo any temperature excursions and the vial was initially stored in the refrigerator on 25-Mar-2022.  No treatment drugs were reported.   This case was linked to MOD-2022-53444.
Employee, 20 year old female, received her first Hepatitis B vaccine on 05/06/2021, ~3:00 p.m. without complaint.  Today, 05/07/2021, she arrived for work at noon stating she feels lightheaded, nauseated, and was vomiting last night.  She stated she has no difiiculty breathing, no rashing, no redness at site, and had no fever today nor yesterday. Clinic was called and employee reported symptoms; Clinic, as well as RN, and Dr, all felt symptoms were unrelated to the Hepatitis B vaccine; but symptoms were reported and VAERS form completed.  Employee stated she ate yogurt and granola today before coming to work and has not had vomiting today and feels she can return to work.
Pulmonary emboli. Patient with history of bilateral pulmonary emboli, "heavy burden". Patient presented to ER with 2 days of progressive dyspnea. She also noticed significant edema in the feet. She was evaluated at ER and found on CTA of the chest to have pulmonary emboli, transferred to hospital where she was evaluated and treated further. She does not remember the details of her visit. We are attempting to get a discharge summary from facility. She was discharged home on Eliquis 10 mg twice daily for several days and is now on 5 mg twice daily. She stopped her daily baby aspirin use. On presentation to ER she had hypotension, tachycardia, hypoxia. She also had the self described marked pedal edema. On examination today she is normotensive with normal heart rate and normal O2 saturation at 96%. Also she has no edema in the ankles/feet. No JVD. She seems to had a split second heart sound on inhalation, otherwise normal cardiac exam. She continues with some excessive dyspnea on exertion, but improved. Her only apparent risk for blood clotting is her BMI of 34.5. She does have history of essential thrombocytosis but her count is normalized on therapy. Also, she has been taking baby aspirin daily prior to hospital admission, interestingly, she did received the Moderna vaccination, first dose January 22, 2021, second dose February 24, 2021. Her dyspnea on exertion began 8 days later, 2 days after the dyspnea began she presented to the emergency room March 6, 2021.   No other complaints.  Physical exam:  General: No acute distress.  Skin: Anicteric. Nondiaphoretic.  Neck: No JVD.  Thorax: Symmetic.  Lungs: Clear with good breath sounds throughout.  Cardiovascular: Regular rate and rhythm without significant murmur, rub gallop. She does seem to have a split second heart sound with inhalation. Otherwise, S1 and S2 Instensity normal. No heaves.  Abdomen: Positive normal bowel sounds. Nondistended. No tinkles or rushes. No bruits.  Back and extremities: Without clubbing, cyanosis, or edema.  Neurologic: Alert and oriented x4. Cranial nerves grossly intact. Ambulates and transfers normally.  Psychologic: Mood is good. Affect is normal.  Assessment and plan:  Bilateral pulmonary emboli, heavy burden: Symptoms began 8 days after her last dose of Moderna COVID-19 vaccination. Clinically markedly improved except continues with dyspnea on exertion. We will check echocardiogram. She will return to office 1 week after echo is performed. She will get in touch with hematology ASAP. Continue NOAC therapy for 3 to 6 months. Remain off aspirin for now.  Essential thrombocytosis: Counts have been normalized with treatment.
injection site after booster is warm; injection site after booster is red; injection site after booster itches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site after booster is warm), VACCINATION SITE ERYTHEMA (injection site after booster is red) and VACCINATION SITE PRURITUS (injection site after booster itches) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Oct-2021, the patient experienced VACCINATION SITE WARMTH (injection site after booster is warm), VACCINATION SITE ERYTHEMA (injection site after booster is red) and VACCINATION SITE PRURITUS (injection site after booster itches). At the time of the report, VACCINATION SITE WARMTH (injection site after booster is warm), VACCINATION SITE ERYTHEMA (injection site after booster is red) and VACCINATION SITE PRURITUS (injection site after booster itches) outcome was unknown.            No concomitant medications reported. No treatment medications reported.   Reporter did not allow further contact
Patient received MMR, VARIVAX, DTAP, and IPV. Pt left and then returned to clinic with patient and said he felt nauseous and had an itchy throat about 5 mins after receiving vaccines. Pt was observed for an hr. Vomited twice and Dr decided to treat with BENADRYL and transport to manage patient's vomiting/dehydration.
Fever 100.4. Localized site pain, redness and swelling x 24 hrs
Something that looks like Acne appeared on both sides of their temples; This spontaneous case was reported by a pharmacist and describes the occurrence of ACNE (Something that looks like Acne appeared on both sides of their temples) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACNE (Something that looks like Acne appeared on both sides of their temples). At the time of the report, ACNE (Something that looks like Acne appeared on both sides of their temples) had not 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.   No concomitant medications were provided by the reporter. No treatment details were provided by the reporter.
This spontaneous report was received from a pharmacist regarding to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, past drugs and concomitant medications were unknown. On 09-JAN-2019 the patient was vaccinated with VARIVAX (dose, frequency, lot# and expiration date were unknown) via intramuscular route (incorrect route of product administration) for prophylaxis, which was reconstituted with sterile diluent (lot# and expiration date were unknown). There were no adverse effects (no adverse event) reported. The outcome of incorrect route of product administration and no adverse event was unknown.
hard knot with swelling and itching for about 3 days; Hard knot with swelling and itching; Itchiness around injection site; Itchiness around injection site; Pain; Swelling around the injection site; Redness around injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (Hard knot with swelling and itching), the second episode of VACCINATION SITE PRURITUS (Itchiness around injection site), the first episode of VACCINATION SITE PRURITUS (Itchiness around injection site), VACCINATION SITE SWELLING (hard knot with swelling and itching for about 3 days) and VACCINATION SITE PAIN (Pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Sulfa), Drug allergy (Codiene) and Penicillin allergy. Concomitant products included AZELASTINE for Allergy, DENOSUMAB (PROLIA) from 07-May-2020 to an unknown date and CALCIUM CITRATE, COLECALCIFEROL (CALCIUM CITRATE WITH VITAMIN D3) for Osteoporosis, MIRABEGRON (MYRBETRIQ) from 07-Feb-2019 to an unknown date and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced the first episode of VACCINATION SITE PRURITUS (Itchiness around injection site), VACCINATION SITE PAIN (Pain), VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around injection site). On 23-Feb-2021, the patient experienced VACCINATION SITE INDURATION (Hard knot with swelling and itching), the second episode of VACCINATION SITE PRURITUS (Itchiness around injection site) and VACCINATION SITE SWELLING (hard knot with swelling and itching for about 3 days). On 16-Feb-2021, VACCINATION SITE PAIN (Pain), VACCINATION SITE SWELLING (Swelling around the injection site) and VACCINATION SITE ERYTHEMA (Redness around injection site) had resolved. On 25-Feb-2021, VACCINATION SITE INDURATION (Hard knot with swelling and itching), the last episode of VACCINATION SITE PRURITUS (Itchiness around injection site) and VACCINATION SITE SWELLING (hard knot with swelling and itching for about 3 days) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.
When I try to stand up I get like a real bad headache; Talking like this with low speech, like real slow; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08May2021 (Lot number: EW0175) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number-1, ER8731 - Lot number), administration date: 17Apr2021, for Covid-19 immunization. The following information was reported: HEADACHE (non-serious) with onset May2021, outcome "unknown", described as "When I try to stand up I get like a real bad headache"; SPEECH DISORDER (non-serious) with onset May2021, outcome "unknown", described as "Talking like this with low speech, like real slow".  Additional Information: Consumer stated, "I have the second dose given to me Saturday and I am having like I don't know this is a side effect when I try to stand up I get like a real bad headache and am talking like this with low speech, like real slow is that normal, Consumer was informed about role of Pfizer Drug Safety department. Consumer was informed about the Pfizer Medical Information Department and provided with the number as and was requested to select option 3, timings as 8am to 8pm Monday to Friday and 9am to 3pm Saturday and Sunday as per EST. Consumer stated, "Is this the side effect do you usually feel like this?" Consumer was informed again about Pfizer Medical Information Department. Consumer further stated, "So, what am I talking to you about then, Consumer was informed about filing safety report. Consumer stated, "It was a bad experience. Just this second shot was very, it was I don't think, it's anything wrong with the shot. I just think it is having an effect on me. Consumer added, "That's all I have to say. You said you are a pharmacist right, Consumer was informed we do not have that information. "Okay, well then I can talk with them tomorrow." Consumer was unwilling to provide further details. Hence, limited information available over the call.  No follow-up attempts are possible. No further information is expected.
Redness and swelling of left deltoid to elbow and neck as well as warmth of arm.  Pt reports she could not even move her arm due to pain.  Generalized body aches.  pain at 4/5 to touch on left upper arm.  Upper body tenderness that prevents her from wearing a bra.  Pt unable to work for two days now.
I experienced an extremely painful and heavy menstrual period, which was the first menstrual period I had after receiving the vaccine.  I experienced the worst pain I ever have had with a menstrual period, along with passing dozens of large blood clots. This is completely abnormal for me and  I have never endured this prior to getting this vaccine. I  have encountered pelvic pain and cramping after my period finished which is also abnormal for me.