chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Polyuria, polydipsia, and headaches for one week, then altered mental status that prompted a visit to the ED. Patient found to be in DKA and was treated per protocol, but altered mental status lasted 2 days. An MRI of the brain without contrast showed subependymal gray-white matter heterotopia along the left lateral ventricle.
My hair started falling out. As much as you might see with a chemo patient. I went to the doctor and she ran labs and found nothing and has referred me to dermatology. She doesn't think it's vaccine-related, but I was told to report it anyway, just in case. I can't get in to see the dermatologist until August.
Severe back spasms- upper back to epigastric with severe pain. lasted Friday night and all day Saturday.  Early Sunday morning it finally passed.
he is breaking out in rash; it's itchy; This is a spontaneous report received from a contactable reporter consumer or other non HCP. The reporter is the parent.  An 11-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 11 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "he is breaking out in rash"; PRURITUS (non-serious), outcome "unknown", described as "it's itchy".  Additional information:-Reporter stated, that his son got the Pfizer shot yesterday. he was 11-years-old and he was breaking out in rash and it's itchy. NDC number of Covid-19 vaccine was unknown. Number of Covid-19 vaccine was unknown. Expiry Date of Covid-19 vaccine was unknown. Reason for no lot number of Covid-19 vaccine: Complainant hung up abruptly/transfer incomplete. Reporter was informed about the role of Pfizer Drug Safety. Reporter asking that is there something they can give him to stop this rash and itching on him. Reporter was informed about the  Information Department and was provided with the telephone# option 3, timings as  8 am to 9 pm, monday to friday, as per. When requested to probe further : Reporter stated, "I am going to call this other number and press 3 because I need to find out if there is something to reverse this rash and itch. Reporter hung up the call abruptly. Reporter was unwilling to complete the report. Further probing could not be done. Hence, limited information available over the call.  comment that reporter type could not be probed hence, captured as consumer or other non HCP by default. Outcome of reaction/event at the time of last observation was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
This spontaneous report as received from a medical assistant refers to an unspecified number of patients of unknown age and gender. No information on the patients' concomitant medications, concurrent conditions, pertinent medical history, drug reactions or allergies was reported. On unknown dates, the patients were orally administered the improperly stored doses of ROTATEQ (lot # reported as M031804 with expiration date on 02-APR-2018; lot # M011832 with expiration date on 25-JAN-2018; lot # M007301 with expiration date on 19-NOV-2017 and lot # reported as M033337 with expiration date on 13-APR-2018; dose was not reported). No adverse effects were reported. Administered doses of vaccines experienced the temperature excursion of 33 degrees Fahrenheit for 30 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA009359: US-009507513-1701USA009357: US-009507513-1701USA009358:
Pt. work up approximately 12 hrs after an ADACEL shot with dizziness and vomiting that has last most of the day. Advised to stay hydrated, see Dr. if worse. (Pt had hit his head on a rusty nail at work earlier in the day, so came for ADACEL).
Right after receiving the vaccine I was driving to.... I was on the frontage road and I started feeling really tired. I was yawning. I kept driving and I felt fine other than feeling sleepy and then I stopped at a stop sign and was very aware that I felt so tired. I drove away from the stop sign and the next thing I knew I was waking up and I had collided with another vehicle. I was taken by ambulance to medical facility. I was there for 2 nights and came home on the 3rd day. I had a fractured Sternum. I was also given a heart monitor that I have to wear for a month to make sure my heart is ok.
received vaccines after a temperature excursion; This non-serious case was reported by a other health professional and described the occurrence of incorrect storage of drug in a 81-year-old patient who received Herpes zoster (Shingles vaccine) (batch number 7KG39) for prophylaxis.   On 03-FEB-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced incorrect storage of drug (Verbatim: received vaccines after a temperature excursion). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 14-Apr-2023 The reporter consented to follow-up. This case is for one of 119 patients, reported by same reporter. The patient received unstable vaccine after a temperature excursion, which led to incorrect storage of drug.; Sender's Comments:  US-GSK-US2023054677:same reporter US-GSK-US2023AMR055743:same reporter
Systemic: Autoimmune Disease (diagnosed by MD)-Medium, Systemic: Fever-Medium, Systemic: Headache-Medium, Systemic: Neurological Disorder (diagnosed by MD)-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extemities)-Medium, Systemic: Unable to Sleep-Medium, Systemic: Weakness-Severe, Additional Details: stabbing feeling on my left big toe..,sharp pain in left hip,electric shocks in fingers,,numbness and tingling ,headache and slight fever
head to toe itching; visible rash in some places; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (head to toe itching) and RASH (visible rash in some places) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 026A21A and 030A20A) for COVID-19 vaccination.     The patient's past medical history included Eczema, Breast cancer and Parotid tumor. Concurrent medical conditions included Depression, Hives, Allergy to plants (allergic to leaf in falls), Allergy to chemicals (Allergy to sulpha) and Allergy to animals (allergic to horse and some dogs). Concomitant products included QUETIAPINE FUMARATE (SEROQUEL), CLONAZEPAM (KLONOPIN), COLECALCIFEROL (VITAMIN D3) and FISH OIL, TOCOPHERYL ACETATE (FISH OIL [FISH OIL;TOCOPHERYL ACETATE]) for an unknown indication, FEXOFENADINE HYDROCHLORIDE (ALLEGRATAB).   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Nov-2021, the patient experienced PRURITUS (head to toe itching) and RASH (visible rash in some places). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (head to toe itching) and RASH (visible rash in some places) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   patient reported of having Antihistamine from her doctor , but of no use.   Most recent FOLLOW-UP information incorporated above includes: On 10-Nov-2021: significant follow up appended Patient medical history ,allergic conditions, and dose details updated. On 10-Nov-2021: follow up received on 10-nov-2021, event outcome updated.
patient passed out about 5 minutes after the vaccine. When i asked her questions, she was responding and was full aware. no rash, no difficulty breathing.  Patient reported feeling "nausea and hot"
Infant had experienced fussiness, sleepiness, and anorexia following his 2nd immunization.  Mother reported reaction 8 wks after immunization.  Infant was afebrile and no treatment was prescribed.
Mother reported decreased appetite, irritable, awakening at night unable to sleep. Fever 102.9F decreased with cool bath. Tylenol/ Advil fever to 100.5F. Lethargic, decreased fluid, paleness of lips, small spot L cheek, rash covered body, 6 days rash still on abdomen.
Menstruation commenced within less than 24 hours following dose 2 of initial COVID vaccine causing disruption in menstrual cycle.  Bleeding and flow were heavier than normal, as well as, cramping in abdomen/ovary area.
Initial report received from a health care provider on 06/Sep/2005.  An eleven-year-old patient with a medical history of bronchitis and upper respiratory infection at time of vaccination received an injection of DECAVAC, lot number U1563CA, in the left deltoid on 06/Sep/2005.  Twenty minutes later, she developed red, watery, itchy eyes and slight edema around her eyes.  She also experienced sneezing.  The patient experienced no difficulty breathing or shortness of breath per the reporter.  She was treated with BENADRYL 25 mg.  At the time of this report, it was unknown if the patient had recovered.
Pt vax with DTP/OPV was doing well on 25JAN90 taken to sitter. Found dead in crib in afternoon.
Patient received 0.2ml dose #1 of pediatric Pfizer covid vaccine.  Vaccine administrator forgot to dilute the vaccine.   Patient had no ill effects immediately.  At a 24 hour check on 5/3 pt reported slight headache.   Overnight from 5/3-5/4 the patient experienced vomiting and diarrhea.  As of approx 6pm on 5/4 the vomiting had stopped but some diarrhea remained.   As of 5/5 4:00pm, all the patient's symptoms have resolved.  He returned to school 5/5, has no ill effects, and is back to normal.
fever; aches; tiredness; headache; This case was reported by a consumer via call center representative and described the occurrence of fever in a 60-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th January 2020, the patient received the 1st dose of Shingrix. On 24th January 2020, less than a day after receiving Shingrix, the patient experienced fever, pain, tiredness and headache. On an unknown date, the outcome of the fever, pain, tiredness and headache were unknown.   It was unknown if the reporter considered the fever, pain, tiredness and headache to be related to Shingrix.  Additional details were provided as follows: The patient received the shot of the shingles vaccine and developed a fever, aches, tiredness, headache. The patient told that his physician's office this reactions like that would not happened that soon after the shot.  The reporter wanted to know, what was the average time period for symptoms to appear after a shingles shot.
At 3:47 pm (36 minutes after receiving shot) tongue swelled lips tingled, increased heart rate, and extremities shook. Called 911 at 3:50 pm.  Fire department came and blood pressure was high, heart rate was high, blood sugar was low. Fire fighter noticed hives on right shoulder (shot was administered in left arm) and they could see hives spreading across chest and neck. Hives covered upper torso but did not spread to abdomen or legs. Tongue swelled more making speech difficult. Breathing was easy, no constriction or wheezing heard through stethoscope. Vitals  taken 2 or 3 more times, becoming more regular each time.  Fire fighters provided Gatorade and discussed options. Fire department left at 4:10. I took Benadryl and Pepcid at 4:15.  Tongue swelling decreased around 6 pm, but remained slightly swollen until 3/14/21. Hives visible and itchy until 3/15/21. Other symptoms included fatigue, dizziness, body aches. Triamcinolone was used topically on hives twice daily on 3/13/21 and 3/14/21.
pt recvd vax & began vomiting, turned purple, shallow breathing, eyes rolled back per mom episode lasted 20 minutes; adm for observation, followed by neurology discharged 2 days later;
Tired; Pain in cheek bone; Pain in Neck; pain on her shoulder around her collar bone; A spontaneous report was received from a consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events tired, pain on her shoulder around her collar bone, pain in cheek bone, pain in neck.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 11 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 006M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 12 Feb 2021, the patient experienced the event(s) tired. On 11 Feb 2021, the patient experienced the events pain on her shoulder around her collar bone, pain in cheek bone, pain in neck.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events, tired, pain on her shoulder around her collar bone, pain in cheek bone, pain in neck was unknown.
redness is spreading in area around; little bit sore; redness at the site of injection; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness is spreading in area around), PAIN (little bit sore) and VACCINATION SITE ERYTHEMA (redness at the site of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced ERYTHEMA (redness is spreading in area around), PAIN (little bit sore) and VACCINATION SITE ERYTHEMA (redness at the site of injection). At the time of the report, ERYTHEMA (redness is spreading in area around), PAIN (little bit sore) and VACCINATION SITE ERYTHEMA (redness at the site of injection) outcome was unknown.            no concomitant medications are provided. treatment to the events not provided.  Action taken with mRNA-1273 in response to the event was not applicable
Begin PM after injection with SOB, Tachycardia and pain in left arm in soft tissue of arm, neck, upper legs and buttocks. Pt reported this on 12/23/04. Injection received 12/20/04. Advised to go to ER. Unk if she went. Follow up 1/10/05 Pt did not go to ER
This spontaneous report was received from a registered nurse refers to a patient of unknown age who on 14-DEC-2012 was vaccinated with an improperly stored dose of (Merck) PROQUAD (dose and route unknown), Lot #: H015623, Exp date: 21-FEB-2014. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Patient's outcome was unknown. This is one of several reports from the same source. Additional information is not expected.
Bruising below the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Bruising below the injection site) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE BRUISING (Bruising below the injection site). At the time of the report, VACCINATION SITE BRUISING (Bruising below the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided  Treatment medication was not provided
10DEC96 inc HR, fever of 102-104, vomiting a lot;no appetite;called MD advised to try tepid bath;@ time of report t102, eyes look weak;been giving chewable APAP;advised to see PCP or clinic acute care;MD felt probably virus;
GENERAL ACHES AND PAINS; SEVERE BACK SPASMS; This spontaneous report received from a patient concerned a 57 year old female. The patient's height, and weight were not reported. The patient's past medical history included back spasms.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 206A21A, expiry: not reported) dose was not reported, administered on 09-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On APR-2021, treatment medications included: paracetamol. On 10-APR-2021, the subject experienced general aches and pains. On 10-APR-2021, the subject experienced severe back spasms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from general aches and pains on 11-APR-2021, and had not recovered from severe back spasms. This report was non-serious.
Feeling dizzy; This spontaneous case was reported by a health care professional and describes the occurrence of DIZZINESS (Feeling dizzy) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Feeling dizzy). At the time of the report, DIZZINESS (Feeling dizzy) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided. No treatment was reported.
hot arm, sore muscle in bicep, trapezius, shoulder blade, fever, chills, sweats, fatigue, insomnia, swollen lymph node, localized red rash, headache, loss of appetite
pruritus, swelling of site affected arm 37cm vs 32cm unaffected arm, erythema of 25 x 25cm area starting 2 days p/2nd dose;tx w/pred, DPH, zantac; dx: allergic rxn to anthrax vax, pt hemodynamically stable; no s/s of systemic rxn
Information has been received from a physician assistant concerning a 16 year old healthy male with no known medical history who on 14-FEB-2007 was vaccinated IM in the left deltoid with a first dose of Vaqta (lot #656320/1281F). Concomitant vaccination the same day included a dose of Menactra given in the right deltoid. On 17-FEB-2007 the patient wasn't "feeling well" and had malaise. He went to tell his mother how he was feeling and had a seizure. He was taken to the emergency room. The CT scan of his head and urine and drug screen were normal. The patient was sent home He had a second seizure the same day and was taken back to the emergency room and KEPPRA was started. The patient was not hospitalized and was treated and released. The patient was seen for follow up at the doctors office on 19-FEB-2007. He was seen by a Neurologist on 20-FEB-2007 who changed his medication from LEPRRA to TOPAMAX. The patient is scheduled to have a neurology work up including an EEG and MRI. At the time of the report the patient was recovering. There was no product quality complaint involved. Upon internal review the patients seizure was considered to be an other important medical event. Additional information has been requested.
Patient reports erythema and fever, swelling, induration at site and generalized hives and Patient reports that signs and symptoms appeared the evening of vaccination date and resolved within 2 days without treatment.
I have headache for 16 days, I had no energy, my whole-body aches like flu, after 17 days I was fine. I still have residual brain fogs; my short memory has been affected.  I got COVID on 7/20/2021. Doctor said I now have COVID Lung. I am taking Zing 15 mg/day., Vitamin B3 6000 IU/day., K290mc a day., B12 Methylcobalamin (nasal spray). I have been referred to Neurologist.
Trouble breathing that progressively got worse within 1 hour of injection.  My oxygen levels dropped and had severe shortness of breath.  The worse part lasted about 2-3 hours after injection.
Information has been received from a health authority concerning a female who on 02-NOV-2007 was vaccinated intramuscularly with a dose of MMR (batch # NE49230). On 03-NOV-2007, one day post immunization, the patient developed symptoms of fever, generalized aches and pains coated tongue, tenderness of glands, runny nose and feeling generally unwell. At the time of reporting the patient had not recovered. The reporter considered this to be a non serious reaction, however, the agency considered the events to be serious due to other medically significant reason. No further information is available, the case is closed. Other business partner numbers include: E2007-08574.