chrisvoncsefalvay/vaers-outcomes huggingface dataset:
no adverse event; Patient accidentally received 2 doses of bivalent booster 3 weeks apart; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (Patient accidentally received 2 doses of bivalent booster 3 weeks apart) and NO ADVERSE EVENT (no adverse event) in a 60-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 016H22A and 021H22A) for COVID-19 vaccination.     The patient had no allergies. The patient had no acute and chronic illnesses at the time of vaccination.    On 10-Nov-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 01-Dec-2022, received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On 01-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (Patient accidentally received 2 doses of bivalent booster 3 weeks apart). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (Patient accidentally received 2 doses of bivalent booster 3 weeks apart) 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 EXTRA DOSE ADMINISTERED (Patient accidentally received 2 doses of bivalent booster 3 weeks apart).    No concomitant medications were reported.  The patient never had COVID positive test or diagnosis. The patient did not receive any other vaccines within 1 month prior to Moderna COVID-19 vaccine. On 21-Mar-2021, the patient received the 1st dose of Moderna COVID-19 vaccine (lot number: 037A20A). On 19-Apr-2021, the patient received the 2nd dose of Moderna COVID-19 vaccine (lot number: 016B21A).  On 04-Nov-2021, the patient received the 1st booster dose of Moderna COVID-19 vaccine (lot number: 039D21A).  On 25-May-2022, the patient received the 2nd booster dose of Moderna COVID-19 vaccine (lot number: 054A22A). On 10-Nov-2022, the patient received the 1st Booster dose of Moderna COVID-19 vaccine, Bivalent. On 01-Dec-2022,  the patient received the 2nd Booster dose of Moderna COVID-19 vaccine, Bivalent.  It was unknown if any treatment was given to patient.
I had got COVID-19. It started off with a heart attack like symptoms. I had a rapped heartbeat. I wore a heart monitor. It kept saying it was abnormal. I was referred to a cardiologist that put me on medication. I then was referred to a heart surgeon. I am now going to have a procedure done called Catheter Ablation. I am unsure if it is COVID or vaccination related. I have now recovered from COVID-19. I did have to go the emergency room and get a higher dose of my heart medication.
Sneezing, nasal congestion, wheezing, coughing, runny nose, stomach pain, shortness of breath. Albuterol neb treatment given in office.
The vial was exposed to refrigerator temperature for more than 24 hours after first puncture.; Administered expired vaccine beyond 12 hours after first puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine beyond 12 hours after first puncture) and PRODUCT STORAGE ERROR (The vial was exposed to refrigerator temperature for more than 24 hours after first puncture.) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 23-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 23-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine beyond 12 hours after first puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was exposed to refrigerator temperature for more than 24 hours after first puncture.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine beyond 12 hours after first puncture) and PRODUCT STORAGE ERROR (The vial was exposed to refrigerator temperature for more than 24 hours after first puncture.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Date the vial was initially stored in the refrigerator: Unknown but liquid unpunctured vial came in a cooler from another facility with beyond use date of 24MAY2022. Date and time vial was first punctured: Vial punctured on 20-May-2022 at 5PM. The vial was stored in refrigerator post puncture. The vial did not undergone any temperature excursion.  No treatment medications was reported.
10 minutes after the vaccine my tongue began to feel weird, I became anxious and felt disoriented.  This passed after about 30 minutes.  8 days after the vaccine I developed a big red itchy spot on my upper left arm.  It is on the interior of my arm and not where they administered the vaccine.  It has been present for 4 days and appears to be improving in color.
Severe arm pain, numbness and tingling in arm and hand on left side. Sharp shooting pain last >7 days.
severe tinnitus onset at 35 hours (permanent and continious),  chills started at 30 hours and lasted 6 hours
Patient had a rash start on his right arm  with in 2 weeks after the first vaccine.  He got a second Moderna Covid vaccine on 7/31/21 and had worsening of the rash and this time in the left arm where he received the vaccine.  He got a Moderna Booster 10/28/21 and his rash became much worse and has extended to his lower legs, feet and worsening of the arms.  It appears to be Lichen Planus.  Biopsy done today and prescribed topical Clobetasol.
The first few days I just felt a little sore. Three days after the injections, I came down with flu-like symptoms (achy, brain fog, headache, fatique, chills) This lasted for three days. I started to feel better for a day and then came down with upper respiratory symptoms (sore throat, fatique , stuffy nose, slight cough, brain fog, no energy, loss of appetite)  As of today over two weeks from injection, I'm STILL feeling off.  Symptoms are like having a mild cold with no energy.
Fever, fatigue, muscle aches, nausea, headache,  treatment was rest, outcome symptoms lasted approximately 36 hours
He had a grand mal seizure; was sleepy; Didn't eat; This spontaneous case was reported by a consumer and describes the occurrence of GENERALISED TONIC-CLONIC SEIZURE (He had a grand mal seizure) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Epilepsy and Lennox-Gastaut syndrome (Diagnosed with a severe form of LGS). Concurrent medical conditions included Speech disorder (He's nonverbal).   On 10-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, the patient experienced GENERALISED TONIC-CLONIC SEIZURE (He had a grand mal seizure) (seriousness criterion medically significant), SOMNOLENCE (was sleepy) and DECREASED APPETITE (Didn't eat). At the time of the report, GENERALISED TONIC-CLONIC SEIZURE (He had a grand mal seizure), SOMNOLENCE (was sleepy) and DECREASED APPETITE (Didn't eat) outcome was unknown.     No relevant concomitant medications were reported.  No treatment information was provided.  Company Comment - This case concerns a 30-year-old, male patient with medical history of Lennox-Gestaut syndrome and epilepsy, who experienced the unexpected events of generalised tonic-clonic seizure, somnolence and decreased appetite. The events occurred on the same day day after the third dose of mRNA-1273. The rechallenge was not applicable, as events occurred after third dose and no further dosing was reported or planned, based on information provided. The above mentioned medical history remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 30-year-old, male patient with medical history of Lennox-Gestaut syndrome and epilepsy, who experienced the unexpected events of generalised tonic-clonic seizure, somnolence and decreased appetite. The events occurred on the same day day after the third dose of mRNA-1273. The rechallenge was not applicable, as events occurred after third dose and no further dosing was reported or planned, based on information provided. The above mentioned medical history remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Information has been received from a medical assistant referring to a patient of unknown age and gender. Information of concomitant therapy, pertinent medical history and drug reactions/allergies was not reported. On 13-NOV-2018, the patient was vaccinated with improperly stored ROTATE (lot # R002805, expiration date: 23-SEP-2019, strength, dose and frequency were unknown) orally for prophylaxis (Incorrect product storage). No adverse effects were reported. The vaccines were exposed to temperature of 47 Fahrenheit (F) for 37 minutes. The temperature excursion was detected by a data logger. Previous temperature excursions were reported as 47 Fahrenheit (F) for 50 minutes. Sender's Comments: US-009507513-1901USA004786.
Large area of induration and erythema, mild warmth on (R) thigh surrounding injection site mark. Walks and uses leg completely normally.
flu like symptoms; fever of 99; chills; nausea; Ache; sick; This is a spontaneous report from a contactable consumer or other non hcp. A 19-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on 23Apr2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Historical vaccine includes patient previously took first dose of bnt162b2 for covid-19 immunization. Reporter is calling about the Pfizer Covid-19 RNA vaccine on behalf of her niece. Reporter stated she is calling for her niece who experienced side effects flu like symptoms fever chills, nausea 10 days after the second dose. she is 19 years old and caller wanted to know if side effects were reported 10 days later. The patient got the second shot on 23Apr2021 at her school. The patient started getting sick after 10 days. The patient had chills, ache, nausea and a fever of 99. The caller was looking online, and it indicates that side effects usually start 1-2 days after the vaccine. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained
Mom states pts injection site became red and swollen.  Pt developed a cough and a "Target like rash" on abdomen.
This physician reported similar events for five patients. Thi sis the first of five reports. This case is non-serious. A child of unknown age and ex was administered a dose of PREVNAR 13, by unknown route of administration on an unknown date. Relevant medical history and concomitant medications were not reported. The physician was an infectious disease pediatrician. He reported that the patient had an unspecified skin reaction and swelling. He stated that a one of their practices, he was seeing an increase in the amount of skin reactions to PREVNAR13 in the 2.4 and 4-year old children receiving this vaccine. The skin reactions were greater than 2 & 1/2 inches in diameter, and they were seeing 5 kids a week at that practice with his swelling. The outcome was unknown.
Time interval between Dose 1 and Dose 2 was more than 30 days; I  have had incessant ringing since the first shot, and it increased in loudness after the second shot.; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (I  have had incessant ringing since the first shot, and it increased in loudness after the second shot.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Time interval between Dose 1 and Dose 2 was more than 30 days) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 007B2I1A) for COVID-19 vaccination.     Patient had never been diagnosed with or tested positive for COVID-19. Patient not had acute illnesses at the time of vaccination and up to one month before.    On 11-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced TINNITUS (I  have had incessant ringing since the first shot, and it increased in loudness after the second shot.). On 09-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Time interval between Dose 1 and Dose 2 was more than 30 days). At the time of the report, TINNITUS (I  have had incessant ringing since the first shot, and it increased in loudness after the second shot.) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Time interval between Dose 1 and Dose 2 was more than 30 days) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported. It was reported that there was no other potential cause for the event tinnitus.   This case was linked to MOD-2021-155644 (Patient Link).
Subsequent to receiving vax the pt experienced redness and a large knot at the injection site. The pt was seen in a physicians office. follow up information indicated that the adverse event in question involved DTAP and not Varivax.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site itching in a 64-year-old male patient who received SHINGRIX (batch number 77PL3, expiry date 18th April 2021) for prophylaxis. On 24th November 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). In February 2019, 91 days after receiving SHINGRIX, the patient experienced injection site itching and injection site erythema. On an unknown date, the outcome of the injection site itching and injection site erythema were recovering/resolving. It was unknown if the reporter considered the injection site itching and injection site erythema to be related to SHINGRIX. Additional case details were reported as follows: The pharmacist reported that about the end of February (or about 3 months after), patient started with redness and itching at the injection site. It had been a very delayed event. At the time of this report, the redness and itching at the injection site was still there. It was tolerable but it was there.
9 days after my second vaccine shot, I developed a patch on my right palm, right below my thumb. It was rough and peeling, about the size of a quarter. It itched and disappeared a week or 2 later, leaving a hyperpigmented spot. In early June, I developed hand eczema that includes small blisters all over my hands and between my fingers. They pop and peel.
(1215) Approximately 5 minutes after recieving flu vaccination client appearing flushed,with c/o dizziness, nausea, tightening of chest; V/S taken 147/83 P 100 RR 26-28 911 Call activiated and Epinephrine 1:1000 1 mg SC (R) UE; Notified supervisor, area health officer and family;(1217) Paramedics to scene; Relative arrived;(1250) Transported to Hospital via paramedic transport.
Case number PHEH2016US026991, is an initial spontaneous report from a nurse received on 17 Oct 2016. This report refers to a 53 years old female patient. Past medical history and concomitant medications were not reported. The patient was vaccinated with single dose of FLUCELVAX Quadrivalent (batch number: 185888) at a dose of 0.5 ml, intramuscularly on 17 Oct 2016. It was reported that, a temperature excursion occurred with FLUCELVAX Pre-filled syringe in a closed refrigerator, vaccines were cool to touch upon discovery. The patient estimates the time of excursion was 02 to 03 days and max temperature was estimated to be less than 77 degrees Fahrenheit. This was the first temperature excursion. It was stated that, vaccine has been given to 07 people this morning on 17 Oct 2016. No adverse event was reported following this medication error.
Accidently used a wasted extra dose  that left in a pfizer vial  and mixed it  with 1.8 ml  Normal Saline. Thinking i was mixing an intact vial. A dose was withdrawn from the affected vial and administered to the patient.
Since patient's first dose of the covid vaccine, he has had sludgy stool; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 91 year-old male patient received bnt162b2 (BNT162B2) (Lot number: Unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "Since patient's first dose of the covid vaccine, he has had sludgy stool".  Additional Information: Since patient's first dose of the covid vaccine, he has had sludgy stool. Reporter called to report her symptoms after receiving the first dose of the covid vaccine. Reporter works in health care. Reporter mentioned that one of her clients, has also been experiencing one of the same symptoms as her  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient received Kinrix at 4 months; Kinrix given instead of Pediarix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received DTPa-IPV (Kinrix) (batch number YZ97N, expiry date 26th August 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DTPa-HBV-IPV (Pediarix).   On 28th October 2020, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 28th October 2020, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device and not applicable after receiving Pediarix, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The patient received 1st dose of pediarix on an unknown date. The reporter stated that, the nurse documented administering a dose of Pediarix to the patient, however search of lot number YZ97N revealed that the dose was actually Kinrix.   The patient was 4 months old and received Kinrix instead of Pediarix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up. This is one of 4 cases, reported by the same reporter.; Reporter's Comments: Pharmacist reports a nurse documented administering a dose of Pediarix to a patient , however search of lot number YZ97N revealed that the dose was actually Kinrix.  The dose was administered on 28Oct2020 (child was 16 months of age).  This was supposed to have been the second dose of the Pediarix series.  The expiration date of the Kinrix dose administered was 26Aug2022.  ~~~~~~~Consented to follow up.Call Notes:HCP gave permission for follow-up; Sender's Comments:  US-GLAXOSMITHKLINE-US2021254893:Same reporter US-GLAXOSMITHKLINE-US2021254961:Same reporter US-GLAXOSMITHKLINE-US2021159295:Same reporter US-GLAXOSMITHKLINE-US2021159292:Same reporter
got COVID19 after vaccination; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (got COVID19 after vaccination) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got COVID19 after vaccination). At the time of the report, COVID-19 (got COVID19 after vaccination) outcome was unknown.            No concomitant products were reported. No treatment drugs were reported  It was reported that caller asked how after having COVID a patient should wait to receive the 2nd booster.  Company Comment: This spontaneous case concerns a patient (age and gender not specified) with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further details on clinical course, other lab test results and treatment received were reported. The outcome of event was reported as unknown. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a patient (age and gender not specified) with no medical history reported, who experienced the unexpected non-serious AESI event of COVID-19 that occurred in the context of mRNA-1273 vaccination. Latency cannot be assessed since vaccination date was not disclosed. No further details on clinical course, other lab test results and treatment received were reported. The outcome of event was reported as unknown. The current pandemic situation of COVID-19 may remain as confounder to the event Covid-19.  The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This spontaneous report as received from a nurse practitioner refers to a 15 year old female patient who on 20-NOV-2012, was vaccinated with the first dose of GARDASIL and on 05-FEB-2014, was vaccinated with the second dose of GARDASIL (doses, routes and lot numbers not reported). No adverse experience has been observed. Additional information has been requested.
Severe joint pain started 9/11/21 in the morning but was gone by afternoon 9/12/21.  Shortness of breath started in the evening of 9/11/21 and still continues on 9/13/21 spo2 levels have remained at 98%.  Severe swelling and redness in my arm at injection site are still present on 9/13/21
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's pertinent medical history concomitant medications and drug reactions or allergies reported. On 19-MAY-2016, the patient was inadvertently vaccinated with (Oka/Merck) VARIVAX (lot#, expiration date, dose, anatomical location and route of administration were not reported) instead of ZOSTAVAX due to nursing error. No adverse effect were reported. Additional information is not expected as the reporter did not want to be contacted.