chrisvoncsefalvay/vaers-outcomes huggingface dataset:
undiluted dose of the vaccine; undiluted dose of the vaccine; This is a spontaneous report received from contactable reporter(s) (Nurse) from medical information team.  An 11-year-old female patient received BNT162b2 (BNT162B2), on 29Jun2022 as dose number unknown (booster), 0.2 ml single (Batch/Lot number: unknown, Expiration Date: 31Aug2022) at the age of 11 years intramuscular, in right deltoid for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OVERDOSE (medically significant), PRODUCT PREPARATION ISSUE (medically significant) all with onset 29Jun2022 and all described as "undiluted dose of the vaccine".  Additional Context: Warm transfer from agent #withheld Medical Information has a LPN who reported that an 11 year old female patient received an undiluted Pfizer BioNTech Covid 19 (orange cap). Stated that she had called and wanted to know what to expect and what they needed to do. Information confirmed as provided. Patient details: Stated that she was 11 years, one week old. Reporter details: Email address captured as provided. Physician details: Does not provide an email address. Treatment: None. Product details: Stated that she needed a magnifying glass.  Description of Product Complaint: Description of complaint: Pfizer BioNTech Covid 19 (orange cap): Stated that she needed a magnifying glass. Product strength and count size dispensed: 10mcg/0.2ml when diluted; unknown count NDC number of Pfizer BioNTech Covid 19 (orange cap).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the known safety profile and Limited information in the case report, a casual association between reported events and the suspect drug cannot be excluded.
Tachycardia, profuse sweating, lightheaded, dizziness, aggressive heart palpitations, Shortness of breath
On 9/2 started feeling lightheaded 2hrs after the shot, then the headaches came in. From this day 9/8, I still feel the headaches and feel fatigue.
a patient (1 patient) that is supposed to received his 1st dose of the Moderna covid19 vaccine but what they gave to the patient was a booster dose; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (a patient (1 patient) that is supposed to received his 1st dose of the Moderna covid19 vaccine but what they gave to the patient was a booster dose) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939904) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (a patient (1 patient) that is supposed to received his 1st dose of the Moderna covid19 vaccine but what they gave to the patient was a booster dose). At the time of the report, ACCIDENTAL UNDERDOSE (a patient (1 patient) that is supposed to received his 1st dose of the Moderna covid19 vaccine but what they gave to the patient was a booster dose) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was mentioned. No treatment medication was mentioned.
Low grade fever, red bumps all over body, irritable, won't sleep, won't eat.
muscle aches on legs; sore arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date: unknown), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the COVID-19 vaccine yesterday (05Jan2021). She had a sore arm and muscle aches on legs that has been expectedly worse on an unspecified date in Jan2021. Outcome of the events was unknown. Patient was asking if it was okay to take TYLENOL for her adverse events.   Information on the lot/batch number has been requested.
Vax given 8AUG90 & 1st signs of weakness occurred that afternoon; Next day @ 130 PM vaccinee c/o progressive sx malaise, weakness, dizziness; BP measured 200/96; on 10AUG90 generalized joint stiffness, swelling & puffiness of hands;
Fever of 100.4 lasted for 1-2 hours, treated with Ibruprofen which effectively lowered the fever
PATIENT RECIEVED 1ST DOSE MODERNA COVID-19 VACCINATION ON 03/23/2021 AT PHARMACY. PATIENT THEN RECIEVED ANOTHER VACCINATION, PFIZER COVID-19 ON 06/18/2021.
Information has been received from a health professional concerning a 11 year old white female with no allergies who on 19-JUN-2007 was vaccinated SC on left arm with a second dose of varicella virus vaccine live (Oka/Merck) (Lot # 657404/0592U). Concomitant therapy included a IM first dose on right arm of meningococcal ACYW conj vaccine (dip toxoid) (MENACTRA) (Lot # U2331AA) and an IM sixth dose on left arm of diphtheria toxoid (+) pertussis acellular 5-component vaccine (+) tetanus toxoid (ADACEL) (Lot # C261CAA). There was no illness at the time of vaccination. It was reported that the patient developed a red hard knot that was itchy, warm to touch and slightly tender after vaccination. No medical attention was sought. At the time of report the patient had recovered. Additional information has been requested. This is one of the several reports received from the same source.
Tachycardia (140s initially); tightness in neck; tingling lips and under tongue; tightness in throat; sweating. She takes Allegra 180mg daily and took 12.5 mg Benadryl prior to injection. After symptoms began, she was treated with Pepcid 40 mg, Benadryl 25 mg, prednisone 40 mg. Symptoms of tachycardia and tightness in neck began almost immediately after injection. Other symptoms began 5-10 minutes later. Symptoms persisted in waxing/waning fashion for about 1.5 hours. Oxygen level remained at 100% on room air. Lungs were clear- no wheezing. She was observed for about three hours. Heart rate was in 80-90 range for the last 1.5 hours.  She was released to home with husband. To continue prednisone 40 mg next three days, then taper off. Continue Pepcid 40 mg daily for 5 days. Benadryl 25 mg every 6 hours as needed for breakthrough symptoms. Continue her usual Allegra 180 mg daily. She has f/u on 2/15/21 or sooner if symptoms return and not controlled with above.
pt recvd vax; exp inject site react & high fever following vax; fever lasted 3-4 days;
Generalized urticaria, pruritis less than 2 hours after vaccination.  Treated with Benadryl and had resolved by next morning.
p/vax pt devel fever 101-104, vomiting-(hx of cleft palate);choking on mucous-adm for observation;discharged this AM 7/16/99;
blotchy red rash 10 days p/vax while on ATB for OM which was started on 9JAN98 same as vaccine;
lightheadedness; felt weak; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (lightheadedness) and ASTHENIA (felt weak) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced DIZZINESS (lightheadedness) and ASTHENIA (felt weak). At the time of the report, DIZZINESS (lightheadedness) and ASTHENIA (felt weak) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
developed profound leukocytosis with WBC >100K following vaccination and previously was 35K
Patient hospitalized for Diverticulitis of large intestine without perforation or abscess without bleeding for 2 hours on 5/6/2021. On 5/20/2021 patient hospitalized for same diagnosis. These visits are within 6 weeks of receiving COVID vaccination.
Redness, swelling at DTaP site, seen by PMD 10/15/04, Dx. with cellulitis, given augmentin and benadryl
It was reported that a 19 y.o. male PT received a Menomune A/C/Y/W-135 vax, administered in his left deltoid on 9/6/01 at 5:25 p.m. Approx an hr later the PT complained of numbness in left arm and chest pain. The PT reportedly recovered from this experience.
Swollen glands in neck and spine, extreme pain arm, soar throat, ear ache, tmj hurts, numbness and tingling in right hand
no adverse event; they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7168B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Jan-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Jan-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (they inadvertently administered 15 doses of the bivalent vaccine which was beyond the 30 use by date).    Concomitant medications were not reported. All of the patients were 12years and above but HCP did not have the information if some of them were below 17 years old.                                     No treatment information was provided by the reporter.   This case was linked to MODERNATX, INC.-MOD-2023-698566 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2023-698566: Master case
Extreme vertigo for 2 weeks. Positional Vertigo for 3 months. 52% permanent damage of left vestibular nerve.
Rash at site of injection; Small bumps covering a 2" X 2" area; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 22Apr2021 at 14:45 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. Medical history included sensitive skin, windburn or sunburn resulted in severe rash. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take any concomitant medications. The patient received any other vaccines within four weeks prior to the COVID-19 vaccine. The patient previously received second dose of Meningitis B (MENINGOCOCCAL VACCINE B) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. On 23Apr2021 at 09:30, the patient experienced rash at site of injection after receiving 1st dose of Pfizer COVID-19 vaccine and small bumps covering a 2" X 2" area. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were not taken as a result of reported events. The clinical outcome of the events rash at site of injection and small bumps covering a 2" X 2" area was recovering at the time of this report.  No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Patient in clinic 10/13/2009-requested H1N1 nasal spray vaccine. Denied pregnancy at time of vaccine. Called clinic 11/10/2009 and reported pregnancy. Denied any reaction to vaccine.
had first shot on 2April2021 second shot 18May2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had first shot on 2April2021 second shot 18May2021) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042B21-2A and 022C1A) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had first shot on 2April2021 second shot 18May2021). On 18-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (had first shot on 2April2021 second shot 18May2021) had resolved.            No concomitant medication details was reported. No treatment medication details was reported.   This case was linked to MOD-2021-416964 (Patient Link).
Case number PHEH2015US019443, is an initial spontaneous report from a pharmacist received on 29 Sep 2015. This report refers to a 39 years old male patient. Medical history and concomitant medications were not reported. The patient was vaccinated with FLUVIRIN PFS (batch number: 157105) at a dose of 0.5 ml intramuscularly on 23 Sep 20155. It was reported that the patient received FLUVIRIN that was out of temperature range at 52 F for 25 days before administration. No adverse event was reported.
This spontaneous report was received from a nurse and refers to two patients of unknown age and gender. No medical history, current conditions and concomitant therapies were reported. On an unknown date, the patients were vaccinated with doses of GARDASIL (lot#, expiration date and doses were not reported) that were improperly stored. No adverse experiences reported. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a 70 years old female patient with melanoma and hypertension and none Drug reactions/Allergies who on an unspecified date was vaccinated subcutaneously with 0.65 ml dose of live ZOSTAVAX, vial 29400 (lot # (h013943, Exp date:25-OCT-2013) and developed a red area, 2 inches in diameter at the injection site (onset date unknown). No other co-suspects were reported. Concomitant medications included losartan potassium (manufacturer unknown), hydrochlorothiazide (manufacturer unknown) and potassium supplement. The patient reported no vesicles or itchiness at injection site. He reported that after three days the redness decreased, but was still present. No treatment was given to the patient. No lab test were performed. The patient did not seek medical attention. The relatedness for the event was unknown for live ZOSTAVAX. Additional information has been requested.
1.26.2022 Employee called the Vaccine Support line to report symptoms post COVID-19 vaccination. Vaccine Name - Moderna Vaccine Date - 1.25.2022 / Location: Right Deltoid Booster Dose - Yes Date of Symptom Onset - 1.26.2022 Symptoms - Body aches, Head throbbing, and Heart racing (Not currently; Experienced earlier this morning) Last Day of Work and Shift - 1.26.2022 / Works Mo - Fr, 8a - 5p.  Employee stated she is feeling bad and may need to leave work.   Home Remedies - Tylenol, 500 mg, 2 tablet, taken once today Any Improvement - No (Employee stated she took about 20-30 mins prior to calling with no symptom relief currently) Recommendation - Treatment per COVID-19 Vaccine Adverse Reaction Triage and Return to Work Procedure algorithm, is to Manage per Illness in the Workplace Policy.  If develops worsening symptoms, return call Vaccine Support or for respiratory symptoms, go to nearest Emergency Center or call 911.
Numbness, tingling and weakness / pain on right side of body that has spread to entire body neck down.
Itchy rash, 1 1/2 ? x 3?, inflamed, red
feeling light-headed, dizzy, and an exacerbation of regularly occurring symptoms.  Pt brought to pt care are.  Vitals taken, pt lying on stretcher
It was given to 2 people beyond the 12 hr mark.; No adverse event; There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.), PRODUCT STORAGE ERROR (It was given to 2 people beyond the 12 hr mark.) and NO ADVERSE EVENT (No adverse event) in a 24-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7148B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2022 at 3:05 AM, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 10-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (It was given to 2 people beyond the 12 hr mark.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.), PRODUCT STORAGE ERROR (It was given to 2 people beyond the 12 hr mark.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (There was an administration error with Moderna Covid-19 Vaccine, Bivalent booster.) and PRODUCT STORAGE ERROR (It was given to 2 people beyond the 12 hr mark.).    No concomitant medications were reported.  It was reported that total 2 patients received the Bivalent booster vaccines post 12 hours of punctured. 1 Vial and 2 doses were given with vial size of 2.5 ml. Vial was initially stored in the refrigerator on 04-Nov-2022. The vial was first punctured on 08-Nov-2022. The vial was stored in the Refrigerator post punctured. The vial did not undergo any temperature excursions. Vial remained Refrigerated within range.  No treatment medication details were reported.   This case was linked to MOD-2022-672831 (Linked Report).; Sender's Comments:  MOD-2022-672831: Patient case
The mother called LCHD reporting as leaving the parking lot. The child started coughing, choking, breathing. Problems and turned pale. Parents rushed the child to the local hospital. Did not come and report to the Health Dept at that time. After treatment and returned home the mother called me. Received steroids and nebulizer treatment at ER.
diagnosed with pnuemonia; covid; not feeling well; Initial information was received on 28-Jan-2021 regarding an unsolicited valid serious case received a consumer/non-hcp (healthcare professional).  This case involves a patient with unknown demography who experienced pneumonia (pneumonia), covid (covid-19) and was not feeling well (malaise), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  On an unknown date in December, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was not feeling well (malaise), (unknown latency) following the administration of INFLUENZA VACCINE  On an unknown date in January, the patient developed a serious pnuemonia (pneumonia), (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  On an unknown date in January, the patient developed a non-serious covid (covid-19), (unknown latency), following the administration of INFLUENZA VACCINE.   It was reported that the patient will not get the vaccine yet, still too soon.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of all the events were unknown at the time of reporting.  Batch number has been requested for suspect product for this case.; Sender's Comments: This case involves a patient with unknown demography who presented with pneumonia, covid-19 and malaise, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. The patient's medical history, medical condition at time of vaccination, concomitant medication and lab test ruling out predisposing etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Initial report of a cluster of six cases with the same lot number was received from a health care professional on the 26/Sep/2005. It was reported that three employees complained of pain and swelling at the injection site. One employee had redness at the injection site and two other employees complained of pain and swelling and had an egg shaped lump at the injection site (and one of these reported feeling flushed without fever). All reported the area was warm to touch.  Symptoms for all patient except one had resolved except for one by 26 September 2005. All patients had received the flu shot in the past with no reactions. This case involves a male patient ( age not reported) developed an oval shaped hard area right below injection site, his face was flushed and his cheeks were red after receiving the intramuscular injection of Fluzone in the deltoid on 21 Sep 2005.  The nurse checked the patient's temperature as he felt feverish but he did not have a fever. Onset date of symptoms and treatment received was not reported. As per reporter the symptoms had resolved by 26 Sep 2005 and patient recovered. Same reported cases 2005-01922, 2005-01924, 2005-01925, 2005-01926, 2005-0192 Follow-up information received on 28 Nov 2005. The patient name and date of birth are clarified. The patient was 30 years old at time of the event. Further information is not expected.
moderna COVID-19 Vaccine EUA    took on 4/5 12:40  chills,achy all over and possibly low grade fever -starting overnight around 1am took 3 doses of Tylenol starting 3am,1 at 10am next day and 1 at 8pm that day no symptoms today other than a little weak