chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event) in a child 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. 216K22A) for COVID-19 prophylaxis.     It was unknown if the patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 10 microgram. On an unknown date, the patient experienced WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) and NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box) 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 assessment was provided for WRONG PRODUCT ADMINISTERED (Pharmacist reported that "we had a couple patients that received 10mcg dosage from the Dark Pink Cap and a Label with a Yellow Box).    Concomitant medication was not provided.  Treatment information was not provided.  This case contains information for the 13th patient out of 18 child patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-723704 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-723704:Patient 1(Master Case)
Fitful screaming for 12 hrs p/vax-starting approx 6 hrs p/vax-no fever;
Vaccination administered to L deltoid at 1250pm with no issues or complaints until 10 minutes later. Patient reported numbness and tingling to L arm, where injection was given, at 1255pm and then reported feeling slight SOB and mild chest tightness around 1305 pm. Requested assistance by LVN,, to monitor patient while NP was being retrieved for medical evaluation. NP presented where a presyncopal episode occurred with patient already reclined in chair; vitals were taken with O2 Sats ranging from 97% to 100% with pulse rate ranging between 67 to 71, RR at 14 - 18 breaths per minute. Breathing was noted to be non-labored. BP was attempted multiple times on LA by RN and LVN before obtaining 139/88 with larger cuff. NP offered to give patient epinephrine, but patient declined as she did not want to go to the hospital. Patient then ? lightheadedness, nausea and scratchy throat as well as facial flushing and feeling hot. Noted productive cough with clear and foamy sputum. Provided water; tolerated well with no emesis. OHN recommended that she contact her closest relative for pick up from TAO to rest. LVN remained with patient for direct observation while patient was allowed time to recover from her reported symptoms. LVN reported to OHN patient ? numbness and tingling around her lips and cheeks as well as weakness in her arms and legs when NP and OHN returned to check in on patient. Noted that patient was on phone with relative discussing pick up from work. Patient was offered epinephrine again by NP, but again declined. Provided stand-by assistance while patient stood up and ambulated slowly to the restroom and was allowed to proceed without direct observation. Patient was noted to be already standing upright when restroom door was opened for escort to sink. Patient reported feeling faint again and was then placed into a chair while EMS was contacted. Patient remained awake and responsive following commands appropriately during entire monitoring period.
Menstrual cycle began 2 weeks early (first cycle after 2nd dose). Unknown at this time if it's a permanent cycle change
A 17 year old patient has taken the first dose of the Moderna Covid 19 Vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient has taken the first dose of the Moderna Covid 19 Vaccine) in a 17-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient has taken the first dose of the Moderna Covid 19 Vaccine). On 08-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (A 17 year old patient has taken the first dose of the Moderna Covid 19 Vaccine) 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.   No concomitant medication reported. No treatment information was provided.
passed out; This is a spontaneous report from a contactable consumer, the patient, from a Pfizer-sponsored program Covax Support. A male patient of an unspecified age received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 27Mar2021 (Batch/Lot number was not reported) as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient passed out on 17Apr2021. The patient was supposed to get the vaccine on 17Apr2021 but he passed out on that day and he missed the shot. The outcome of event, passed out, was unknown.    The lot number for the vaccine, BNT162b2, was not provided and will be requested during follow up.
Intense itchiness, starting on thighs and proceeding randomly to other parts of body. Rash/wheels developed shortly after itchiness started, and it also appeared in random spots on body. Rash and itchiness would appear and disappear at seemingly random times, durations, and locations. Urgent care center prescribed prednisone and hydroxyzine; dermatologist and primary care physician subsequently confirmed that was likely the right course of action. Dermatologist diagnosed dermatographism. After prescriptions ended,  I found Zyrtec 10-20mg/day to be ~90% at relieving symptoms, which the dermatologist recommended. But symptoms return after 24 hours and become significantly intense after 36-48 hours.
MOM STATES THAT THE NEXT MORNING AFTER PATIENT RECEIVED HIS FIRST DOSE OF VARIVAX HE BROKE OUT IN A RASH AND WAS DIAGNOSED WITH CHICKEN POX AT HIS LOCAL PEDIATRICIAN'S OFFICE.
Patient rec'd PREVNAR 13 3/18/16 - on 3/21/16 pt developed redness, swelling and warmth at injection site - evaluated by provider on 3/22/16.
patient given expired vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient given expired vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Concurrent medical conditions included Clot blood and Blood disorder. Concomitant products included ASA for Blood disorder.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient given expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have immediate allergic reaction to any vaccine, injection or shot or to any component of COVID-19 vaccine or a severe allergic reaction to anything. Patient did not had history of cancer, leukemia, HIV/AIDS or any other condition that weakens the immune system. In the last 10 days, patient did not have COVID-19 test because of symptoms or isolated or quarantine at home due to COVID-10 infection or exposure. On 22-Dec-2021, patient was treated with antibody therapy or convalescent plasma for COVID-19 in the past 90 days. Patient was not taking any medications that affect immune system such as cortisone, prednisone or other steroids, anticancer drugs or had radiation treatments. Patient did not have history of myocarditis or pericarditis. Patient was not taken any other vaccines and did not develop thrombosis with thrombocytopenia syndrome. Patient was not feeling seek on the day of vaccination.
Rash all over her body; A spontaneous report was received from a consumer concerning a 59-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rash all over her body/ rash.  The patient's medical history included high blood pressure. Products known to have been used by the patient, within two weeks prior to the event, included lisinopril.  On 25 Feb 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 031L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 25 Feb 2021, the patient experienced  allergic reaction of rash all over her body.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of event rash all over her body was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded
Coughing, hoarseness that worsened over evening, scratchy throat, scratchy left eye, pain at site, sore throat, frequent feeling of needing to swallow and clear throat.
Patient reports she received the Moderna covid 19 vaccine lot number 039K20A on 12/31/2020 on her left arm. She received it at the a physicians building. Patient reports the vaccine was lower on her arm.  She reports she had pink irritation which resolved. Patient reports on 1/7/2021 she noted increased redness and swelling. Patient reports she went to the ED and was advised to monitor. Patient reports she was started on Keflex and treated for cellulitis. Patient reports the redness an inflammation is resolving. VAERS completed.
Soreness in arm shortly following, by 9 pm chills and body aches. Throughout night chills, aches, tightness in chest. The following by morning (2/5) at about 9 and 10 am, BP elevated (129/93) and heart rate between 120-122, persistent tightness in chest that sometimes causes slight cough.  Fatigued.
-Skin rashes over face and neck -Total impotency. -June 6th I had a 3mm kidney stone that I have yet to pass. -July 11th I had a severe aura while driving, that lasted better than 30 minutes. -Aug 6th, I developed Bell's Palsy to the right side of the face. -Blood tests revealed that I now have only 50% functionality of my kidneys. -Blood tests revealed that I now have high PSA levels and require a prostate biopsy.
Patient was intended to receive COVID Bivalent Booster and instead received Prevnar 20 vaccine. Patient was able to receive Covid booster once error recognized.  Lot number, dose, site, route, manufacturer and lot number for Prevnar 20 is not available.
salivary gland infection; pain under my jaw on the left side; This is a spontaneous report from a contactable consumer (patient). A 71-year-old male patient received the first dose of BNT162B2 (Lot Number: EN6198), via an unspecified route of administration, administered in left arm on 10Mar2021 11:15 AM (at the age of 71-year-old) at single dose for COVID-19 immunization. Medical history included diabetes, hypertension and gout. Concomitant medication included unspecified blood thinner and blood pressure medications. On 11Mar2021 at 10:00 AM, the patient developed salivary gland infection and pain under his jaw on the left side as diagnosed. The adverse events resulted in doctor or other healthcare professional office/clinic visit. The patient was prescribed with antibiotics for 7 days. No COVID prior vaccination and the patient was not tested with COVID post vaccination. The outcome of the events was recovering.
Headache, myalgia and fatigue, body aches, chills, temp=101, sweats and headache.
tongue swelling; This case was reported by a consumer via call center representative and described the occurrence of swollen tongue in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a week after receiving Shingrix, the patient experienced swollen tongue. On an unknown date, the outcome of the swollen tongue was recovered/resolved.   The reporter considered the swollen tongue to be possibly related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient experienced a possible adverse reaction to having the Shingrix vaccine. About 1 to 2 days after receiving the shot, the patient stated that she experienced tongue swelling for about an hour or so.
Dizziness, Headache, Myalgia, & CoughWheeze Narrative:
Child's mother called 3/17 concerned about "silver-dollar sized", red, swollen area on right thigh at site of #4 DTaP given 3/15. On 3/18 mother brought child in- said site looked better. Appeared splotchy, slightly swollen, dollar sized. No other s/s of problems.
Complained of vertigo. She is subject to vertigo but it was so bad she went to the Emergency room.
She explained she had dinner at a friend's house where she was in contact with a person who tested positive to COVID-19.; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a 77-years-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient is not pregnant at the time. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The caller stated that she was scheduled to receive the second dose of the second dose of the Pfizer-BioNTech COVID-19 vaccine on 02Mar2021. She explained she had dinner at a friend's house where she was in contact with a person who tested positive to COVID-19. She specified this person was informed this morning that she was exposed to a confirmed positive case at work home and thus got tested. Caller added she doesn't have any symptoms and asked if she can receive her second dose as planned. She then explained a nurse at (Hospital name withheld) recommended her to get tested for COVID-19 in 5-7 days. Caller stated she doesn't have the number to her vaccination provider. She explained she will not be able to call them to reschedule the second dose of the COVID-19 vaccine and asked if we can assist her. While on hold, caller stated she was able to find a phone number to call for questions / to reschedule her appointment, and therefore she will not need our references. Outcome of the event was unknown.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
DEEP VEIN THROMBOSIS; This spontaneous report received from a physician concerned a 62 year old male of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2021) dose, 1 total, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, 3 to 4 weeks post vaccination, the patient experienced edema in legs and deep vein thrombosis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the deep vein thrombosis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211118921- COVID-19 VACCINE AD26.COV2.S-  Deep vein thrombosis. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.
I am the epidemiologist reporting on behalf of 73 year-old female patient.  The patient received two doses of the Pfizer Vaccine: First: 2/27/2021 Second: 03/20/2021 The patient was found dead at home on 3/27/2021 (7 days post second dose). The immediate cause of death listed on the death certificate is ?cardiopulmonary arrest? (few minutes) secondary to ?arrhythmia? (few minutes) and ?hypertensive heart disease? (few years). I do not have any additional information about other underlying conditions that may have contributed to this person?s death.
Chills/fever/body ache/severe overall pain/ fever between 99.7 to 101.7 for 2 days/Tylenol 500 mg every 4 hrs for 2 days  Like to know what precaution I can take before the second dose schedule for 04/03/2021 to avoid the same severe condition.
huge red spot (3in by 4in) where it was injected and it's itchy; huge red spot (3in by 4in) where it was injected and it's itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (huge red spot (3in by 4in) where it was injected and it's itchy) and VACCINATION SITE ERYTHEMA (huge red spot (3in by 4in) where it was injected and it's itchy) 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.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (huge red spot (3in by 4in) where it was injected and it's itchy) and VACCINATION SITE ERYTHEMA (huge red spot (3in by 4in) where it was injected and it's itchy). At the time of the report, VACCINATION SITE PRURITUS (huge red spot (3in by 4in) where it was injected and it's itchy) and VACCINATION SITE ERYTHEMA (huge red spot (3in by 4in) where it was injected and it's itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medicines were reported. Treatment information was not provided. Patient got the vaccination shot on the 22nd (exact date unspecified).
09/16/22 presents to EC ED for "shortness of breath, rib pain". PMHx of "hypertension"
This spontaneous report was received rom a physician via a company representative, and refers to a patient (Encounter key# 101254) of unknown age and gender. The patient's medical history, concurrent conditions and drug reactions/allergies were not reported. On 23-JAN-2014, the patient was vaccinated with an improperly stored dose of GARDASIL "HPV 10x1 sdv", lot # J009788 with expiration date of 17-MAR-2016 (strength, dose and route of administration were not reported). No concomitant medications were reported. No adverse effects and no product quality complaints were involved. On an unknown date, the vaccine was stored at a refrigerator and the reported temperature excursion lasted 72 hours, where the lowest recorded temperature was 32 F (0 Celsius degrees). There was also another excursion on an unknown date which lasted 24 hours with lowest recorded temperature of 34 F (1.111111111 Celsius degrees). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of several reports received from the same source. Additional information has been requested.
1:00 am (15 hours post injection) chills, fever, body aches,  4:00  am (18 hours post injection) nausea, vomit, dizzy, fainted 3 times 8:00 am(22 hours post injection) severe headache, fever lasting 8 hours
Onset of acute dizziness and near syncope 8/16/21 requiring in clinic evaluation.
Pt received the J&J COVID-19 vaccine on 3/14/2021 followed by chills, abdominal pain, headaches and fatigue started the night of the vaccine injection. Pain controlled with Tylenol prn. Improvement to symptoms today, 2 days later
Information has been received from a company representative and health care facility concerning a 7 year old female who on 04/12/1996 was vaccinated with a dose of varicella virus vaccine live. On 01/19/2002, the pt presented to the physician's office with chickenpox. She broke out in a rash all over her body and this was not a mild, but serious case of varicella. However, there was no documentation in the pt's chart as to the number of lesions she had. Subsequently, she recovered. It was reported that another pt (WAES0203USA00269) had a similar experience following exposure to varicella virus vaccine live. Additional info has been requested.
No additional AEs or PQC reported; ROTATEQ administered after temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about pertinent medical history, drug reaction/allergy and concomitant medication was not provided.   On an unknown date, rotavirus vaccine, live, oral, pentavalent (ROTATEQ) experienced temperature excursion with 49.8 Fahrenheit degrees for 2 hours. There was no previous temperature excursion.    On 20-JUN-2022, the patient was vaccinated with the improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (2 ml, lot# U006165, expiration date 18-OCT-2022; strength was not reported) orally for prophylaxis (product storage error). No additional adverse events (AEs) or product quality complaint (PQC) was reported.
Few spots of rash noted prior to event.  Family at restaurant and child had a stiffening spell (?seizure?).  By the time child was carried to car by father to go to ER, child was back to normal.  No medical care obtained.  No further events.  No fever.
has not received dose two.; This case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Hepatitis A vaccine for prophylaxis.   Previously administered products included Hepatitis A vaccine (1st dose (manufacturer unknown) received 10 years ago from reporting date).   On an unknown date, the patient received the 2nd dose of Hepatitis A vaccine. On an unknown date, unknown after receiving Hepatitis A vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient had not received dose two, which led to incomplete course of vaccination. The physician did not decline or consented to follow-up.