chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache) in a 67-year-old female patient 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 HEADACHE (Headache). At the time of the report, HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
The patient has developed Gastroparesis from the Covid vaccine he was required to take he cant eat, he pukes when he wakes up in the morning, has severe gastric pain, he is loosing weight, he recently was fired from his job, it has affected pretty much every part of his life
Doctors suspect aTTP; platelets were very low so they gave her a transfusion.; Fatigue; Headaches; Numbness; Weakness; Speech began to get slurred; This is a spontaneous report from a contactable consumer or other non hcp.     A 24-years-old female patient received bnt162b2 (BNT162B2) dose number unknown , 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 experienced doctors suspect a TTP (thrombotic thrombocytopenic purpura) (medically significant) on an unspecified date with outcome of unknown , platelets were very low so they gave her a transfusion.  (medically significant) on an unspecified date with outcome of unknown , fatigue  (non-serious) on an unspecified date with outcome of unknown , headaches  (non-serious) on an unspecified date with outcome of unknown , numbness  (non-serious) on an unspecified date with outcome of unknown , weakness  (non-serious) on an unspecified date with outcome of unknown , speech began to get slurred  (non-serious) on an unspecified date with outcome of unknown.  The patient underwent lab tests and procedures which included platelet count decreased: very low .  Therapeutic measures were taken as a result of platelets were very low  and included a transfusion.   Doctors suspect a TTP and she had the Pfizer vaccine so they suspect the two could be linked.  Information about lot/batch number has been requested.
This case was reported by a healthcare professional and described the occurrence of diarrhea in a 7-month-old female subject who was vaccinated with PEDIARIX. Previous and/or concurrent vaccination included two unspecified vaccines given on 19 May 2011. There were no concurrent medications. The subject had no known relevant medical history. On 19 May 2011 at 11:30 the subject received unspecified dose of PEDIARIX (unknown, unknown thigh) that was stored at incorrect temperature conditions. The physician's office told the reporter that due to a recent power outage, the vaccine was "compromised and not kept in proper temperature conditions". The vaccine was then inadvertently administered to the subject. On 20 May 2011, one day after vaccination with PEDIARIX, the subject experienced diarrhea. At the time of reporting the diarrhea was improved.
FIRST GAVE MENACTRA IN RIGHT ARM AND PATIENT HAD NO REACTION.  THEN, GAVE TDAP IN LEFT ARM AND IMMEDIATELY AFTER, WHILE PATIENT WAS SEATED ON EXAM TABLE, SHE TURNED PALE, HER PUPILS DILATED, AND SHE STARTED TO LEAN BACK.  SHE AND HER MOTHER LOWERED HER ON THE EXAM TABLE UNTIL SHE WAS LAYING DOWN.  SHE WAS LAYING DOWN FOR ABOUT 2-3 MINUTES, SAID SHE FELT A LITTLE BETTER AND TRIED TO SIT UP.  HER PUPILS DILATED AGAIN AND SHE STARTED TO HAVE VERY MILD SEIZURE-LIKE ACTIVITY IN WHICH HER UPPER AND LOWER LIMBS CONVULSED FOR ABOUT 2-3 SECONDS BEFORE SHE WAS LAYED BACK ON THE EXAM TABLE.  SHE LAID ON EXAM TABLE FOR ABOUT 10 MORE MINUTES.  I SUGGESTED SHE GO TO ED.  WE OBTAINED WHEELCHAIR AND MOM AND I HELPED PATIENT TO CHAIR.  DAD PULLED TO FRONT OF STORE TO PICK UP.  MOM SAID THEY WOULD TAKE HER TO ER.
Severe muscle ache and trismus radiating from  the Deltoid (site of injection) throughout the entire shoulder, including the Trapezius and Sterno-Cleido-Mastoid  muscles.   These conditions lasted for one week, until my Orthopedist (whom I saw for follow-up knee replacement) prescribed a Medrol Doz-pak, which finally gave me relief.
Pt returned to Mobile Health Unit 10 mins after vaccine administered with SOB, and heaviness in chest area. VS BP 120/80, P-140, R-26. EMS activated. Pt transported to SIUH-N ED. Follow up call made and pt verbalized that ED administered Benadryl. Spoke to pt at home and she stated she no longer has any acute distress
Patient received 3rd dose and they were not immunocompromised; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (Patient received 3rd dose and they were not immunocompromised) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced OFF LABEL USE (Patient received 3rd dose and they were not immunocompromised). At the time of the report, OFF LABEL USE (Patient received 3rd dose and they were not immunocompromised) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Treatment medication was not provided by the reporter.
had Moderna and got Pfizer 2 months later; had Moderna and got Pfizer 2 months later; they had to call back to the hospital for permission to be able to combine 2 drugs to flat line her a minute before they could re-start her heart properly; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (Reporter's friend). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), via an un-specified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. The patient medical and concomitant medication history were reported. Historical vaccine included: first dose of MODERNA COVID-19 VACCINE for COVID-19 immunization. It was mentioned that, patient was looking for the 3-D form of the protein that's being formed, by our human cells. Patient want to see the quaternary form of the spike protein being formed, nothing there in the gene bank for it. Patient was upset that this information was not available to the public so that they can verify quality control measures for themselves. Patient believes these quality control measures would involve cryotransfer electromicroscopy, and crystallography. Caller was asking for more transparency, as this information should be available in protein banks and that a manual should have been created for it [COMIRNATY]" as patient having to work backwards to find the information needs. The 3-D form of the protein that's being formed, by our human cells was not available to the front line. Patient proceeded to explain the SDS to agent over the phone. Caller also reports another friend had to call the ambulance they had to call back to the hospital for permission to be able to com-bine 2 drugs to flat line a minute before they could re-start heart properly. Patient was in the telemetry unit for a week. Caller asked how exactly the spike protein gets to the surface of the cells after vaccination with COMIRNATY? It was reported that through research a Cation can form an electrostatic bound to the endosome of the muscle cell. Ribosomes would actually form spike protein. Consider the risk of these vaccines to be quite high and added feel like raped everyone with this vaccine, when did not provide all of the information to the general public and patient was asking for more decency. The outcome of the events were unknown.   The lot number was not provided. Information on lot number has been requested during follow up. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101212357 same reporter/drug, different patients.
administered the HIGH DOSE to patients under 65 with no adverse event; Initial information received on 18-Oct-2022 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves an unknown age/gender patient who experienced administered the high dose to patients under 65 with no adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ904AD; expiry date: 30-Jun-2023) in unknown administration site for immunization.  On an unknown date the patient developed a non-serious event administered the high dose to patients under 65 with no adverse event (product administered to patient of inappropriate age) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Fever,; Chilis/shivering; tiredness; headache; feeling unwel; hot flashes; muscle pain; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ep7533) via an unspecified route of administration in the arm right on 31Mar2021 at 10:15 (at the age of 43-year-old) as a single dose for COVID-19 immunisation. Concomitant medications included vitamin c [abscorbic acid] (MANUFACTURER UNKNOWN) and vitamin b12 (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 31Mar2021 at 12:00 the patient experienced fever, chills, shivering, tiredness, headache, feeling unwell, hot flashes and muscle pain for 5 days with those symptoms. On 04Apr2021, the patient underwent a COVID-19 rapid test (Nasal Swab) and the result was Pending. The patient did not receive any treatment for the reported event. The events did not result in doctor or other healthcare professional office/clinic visits, and the emergency room/department or urgent care. The clinical outcome of the events Fever, Chilis, shivering, tiredness, headache, feeling unwell, hot flashes and muscle pain was recovering at the time of the report.   No follow-up attempts are possible. No further information is expected.
experienced vertigo; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VERTIGO (experienced vertigo) 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 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 VERTIGO (experienced vertigo). At the time of the report, VERTIGO (experienced vertigo) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. No Treatment information was provided.
Information has been received from a physician concerning a 10 year old female with CYTOXAN allergy who in May 2007 was vaccinated with the first dose of GARDASIL. In July or August of 2007, the patient was vaccinated with the second dose of GARDASIL. There was no concomitant medication. The patient has not yet received the third dose. The patient first experienced high fever and rash in July 2007. The patient was diagnosed with lupus. She then progressed to having seizures and kidney insufficiency. The patient lost all neurological functions including the ability to walk and talk considered to be disabling. She was hospitalized from 23-NOV-2007 to 30-JAN-2008 until there was some improvement. The patient was given oxygen while in the hospital. The patient still can not walk but able to recover her speech. The patient was considered to be recovering from lupus, seizures and renal insufficiency. Seizures were considered to be immediately life-threatening. Lupus, seizures, loss of ability to walk and talk and kidney insufficiency were considered to be an other important medical events and disabling by the physician. Additional information has been requested.
Arrived at hospital on 6/13/12 at 1:25 am - presents with episode generalized shaking, eyes opened, increased saliva, no vomiting during event. Lasting x 10 mins. Took 10-15 mins for child to be back to normal status. No fever. Denies new rash, diarrhea, vomiting, URI, behavior change.
Fever 101.3 Muscle aches 3? diameter redness and swelling about 2 inches below the injection site with several bumps contained in swelling area
Received second dose of Covid-19 Moderna vaccine on 2/8/21.  On 3/10/2021 she went to ophthalmologist for normal checkup.  Did have her eyes dilated (Tropi-Phen). 3/14/21 started having what she thought was floaters in her left eye, has a history of floaters. Then 3/16/21 got worse with blurred vision in both eyes. 3/22/21 Retinal specialist diagnosis of panuveitis with significant vitritis and retinal vasculitis on angiogram. On 3/24/2021 she was started on 60 mg of prednisone daily along with Prednisolone acetate eye drops. Vision beginning to improve.  Due to ADRs from steroids (SOB, insomnia, hyperglycemia, myopathy) , started on Humira 4/27/21 with goal to taper steroids.  Patient has been unable to work due to vision issues.
Administer Expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) in a 36-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine). On 24-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administer Expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that the vaccines was stored in freezer, they took out one to two vials and place in fridge each day as needed.  No concomitant medications were reported.  No treatment medications were reported.
Within 24 hours developed erythema at the injection site that covered the majority of the deltoid.   Rash was not bothersome and he had no other symptoms.  Erythema gradually changed to a mottled pattern that is reddish purple.  Rash has not decreased in size though has potentially faded a little bit.  Parents are observing rash at home.  No interventions.
A serious spontaneous important medical event of autistic type symptoms has been received from a consumer concerning a seven-year old male. The patient had a medical history of autism; no concomitant medications were provided. On 16-Oct-2008, the patient received a dose of FLUMIST. On 17-Oct-2008, the patient experienced autistic type symptoms (arms flopping, repeated vocal sounds, more than normal agitation, and unusual movement of his head and neck) one day after receiving FLUMIST. Per the mother, these symptoms have been present for the last two weeks and there was an unsuccessful attempt to reach the patient's physician. Outcome for the events was not provided by the reporter. The reporter thinks that "FLUMIST might be the cause of these symptoms".  The following information was received for this case: 1) Pt's date of birth is May 5, 2001. 2) Lot number is not available. This information was submitted on Nov 21, 2008.
Pt describes at ten days post vaccine "intense chest and upper back/shoulder muscle spasms, pain and SOB" requiring pain medication and a visit to the ER. Subsequently experiencing an itching/burning head to toe rash and red bumps lasting about a week. Then it took "a few more weeks before the dry patches cleared up".   No report of fever.
Slight itching in area consistent with past HSV outbreak. By 5:30 AM 11/6/09 was no doubt it was an outbreak (mile only). Already on daily maintenance dose of Valtrex, took extra dose (500 mg) that morning and will continue for 5 days BID.
Burning and discomfort; Burning and discomfort; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning and discomfort) and DISCOMFORT (Burning and discomfort) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided by the reporter.  Concomitant products included LOSARTAN from 09-Oct-2016 to an unknown date and OMEPRAZOLE from 07-Aug-2016 to an unknown date.    On 12-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced BURNING SENSATION (Burning and discomfort) and DISCOMFORT (Burning and discomfort). On 12-Feb-2021, BURNING SENSATION (Burning and discomfort) and DISCOMFORT (Burning and discomfort) had resolved.        The action taken with  mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.   No treatment of events was reported.   This case was linked to MOD-2021-008973 (Patient Link).
numbness in the arm of the injection; body aches,pain all over the body; extremly sore arm; A lot of fatigue; fever of 100-101F; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (numbness in the arm of the injection), PAIN (body aches,pain all over the body), PAIN IN EXTREMITY (extremly sore arm), FATIGUE (A lot of fatigue) and PYREXIA (fever of 100-101F) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced HYPOAESTHESIA (numbness in the arm of the injection), PAIN (body aches,pain all over the body), PAIN IN EXTREMITY (extremly sore arm), FATIGUE (A lot of fatigue) and PYREXIA (fever of 100-101F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (numbness in the arm of the injection), PAIN (body aches,pain all over the body), PAIN IN EXTREMITY (extremly sore arm), FATIGUE (A lot of fatigue) and PYREXIA (fever of 100-101F) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication provided.
Patient complained of burning when the meningococcal B vaccine was given in the right arm. The patient states the arm became very sore and red that evening. She took TYLENOL and kept cold compresses on it. The arm has become increasingly sore to the point of not being able to lift the arm. The redness and swelling are still present almost a week after the shot. Patient states that last night itching started at the injection site. Patient is seeking care with her MD today or tomorrow.
Sore arm; given almost 2ml of the product, instead of 0.3ml.; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team.  A 14-year-old female patient received BNT162b2 (BNT162B2), on 23Aug2022 as dose 3 (booster), 2 ml single (Lot number: FP7150, Expiration Date: 16Oct2022) at the age of 14 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Past history of mixed hyperlipidemia" (unspecified if ongoing); "Vitamin d deficiency" (unspecified if ongoing); "High serum cholesterol borderline" (unspecified if ongoing); "autoimmune thyroiditis", start date: 2018 (unspecified if ongoing). There were no concomitant medications. Vaccination history included: BNT162b2 (Second Dose, NDC, LOT, EXP: Unknown ), administration date: 08Jun2021, when the patient was 12-year-old, for Covid-19 immunization; BNT162b2 (First Dose, Covid-19 vaccine, purple cap NDC, LOT, EXP: Unknown), administration date: 29May2021, when the patient was 12-year-old, for COVID-19 immunization. The following information was reported: OVERDOSE (non-serious) with onset 23Aug2022, outcome "unknown", described as "given almost 2ml of the product, instead of 0.3ml."; PAIN IN EXTREMITY (non-serious) with onset 24Aug2022, outcome "unknown", described as "Sore arm".  Additional Information: Caller was reporting an administration error for the Pfizer COVID vaccine gray cap that had been administered to a patient. Caller confirmed that the patient was given almost 2ml of the product, instead of 0.3ml. Caller wants to know if there was anything the patient can do or any guidance about this error and if there are side effects to look after the error. Caller also mentioned that it was for the booster dose of the patient. Reporter called because they were concerned that an employee gave the wrong Covid vaccine. Found out, the correct Covid vaccine was given but was given the wrong dosage. Dose was supposed to be 0.3ml and patient was given almost 2ml, which was too much. Patient had no reaction other than a sore arm. Patient had no additional vaccines administered on same date of the Pfizer suspect. AE(s) did not require a visit to Emergency Room or Physician Office. Patient had no prior vaccination (within 4weeks) and had no AE(s) following prior vaccinations. No family medical history relevant to AE(s). Patient had no relevant tests done.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.  Follow-up (23Aug2022 and 24Aug2022): This is a spontaneous follow-up report received from a contactable other HCP. Updated information: new reporter, patient details, medical history, historical vaccine, vaccination details, new event.
The pt developed a fever of 101 rectally. Was admitted to hospital for full septic work up.
15-20 min post vax, vomitted in car on way home. Vomitted twice at home. At ER, viral syndrome.
AFTER GIVING THE SHOT PT REPORTED SEVERE HEADACHE, DIZZINESS  AND SHAKY CALLED 911 ,PT REQUESTED TO LIE DOWN ON THE FLOOR , PT WAS BREATHING AND CONSCIOUS ALL THE TIME TILL AMBULANCE WAS HERE AND CHECKED BY THE EMERGENCY STAFF CREW, TOOK HER TO THE HOSPITAL