chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pityriasis Rosea; This spontaneous case was reported by a pharmacist and describes the occurrence of PITYRIASIS ROSEA (Pityriasis Rosea) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003K21-2A, 050E21A, 027A21A and 029L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 31-Mar-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PITYRIASIS ROSEA (Pityriasis Rosea). The patient was treated with PREDNISONE (oral) for Pityriasis rosea, at a dose of tapering dose for up to 12 days. At the time of the report, PITYRIASIS ROSEA (Pityriasis Rosea) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant product use was provided.  The patient noticed a rash(spot), which was later diagnosed as Pityriasis Rosea (a viral immune related rash) which presented on his chest. This "multiplied" throughout his trunk to his chest and back. It had continued up until at the time of reporting. The patient spoked to his primary care doctor and a dermatologist. Following the dermatologist appointment 3 days ago, he was prescribed a tapering dose of oral prednisone for up to 12 days. The taper was as follows 40mg for 3 days, 30mg for 3 days, 20mg for 3 days, and 10 mg for 3 days. He started the 30mg for 3 day dosage at the time of reporting. His rash has been improving after taking this medication. He also tried some over the counter lotions and creams that did not provide improvement prior to taking the prednisone.   This case was linked to MOD-2021-353240, MOD-2021-353257 (Patient Link).
6:00pm vomited (small amount) 3:30am went to get out of bed and left arm and leg did not work and she fell. 7:00am Left arm and leg  felt tingling in them and speech slightly slurrded. By 10:00am no symptoms remaining.
This spontaneous report was received from an Office Manager and refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On 08-AUG-2017, the patients were vaccinated with improperly stored doses of ROTATEQ injection with lot number: M039661 and expiry date: 28-APR-2018 (exact dose, route of administration, were not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (lot number and expiration date not reported). There were no concomitant therapies reported. The administered doses of the vaccine were exposed to a temperature between 47 degrees Fahrenheit to 77 degrees Fahrenheit on an unspecified date, for a time frame of 16 hours. A digital data logger was not involved. There were no previous temperature excursions recorded. No adverse experiences were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Lot number M039661 is an invalid lot number for rotavirus vaccine, live, oral, pentavalent vaccine. Sender's Comments: US-009507513-1708USA004174: US-009507513-1708USA005225.
vaccine was  given after patient was 15 weeks old. Patient had no adverse reaction to vaccine.
LOCAL TITLE: EMERGENCY                                           STANDARD TITLE: EMERGENCY MEDICINE NOTE                          DATE OF NOTE: JAN 10, 2022@12:35     ENTRY DATE: JAN 10, 2022@12:35:34             AUTHOR:            EXP COSIGNER:                                 URGENCY:                            STATUS: COMPLETED                          *** EMERGENCY Has ADDENDA ***  ER Triage Note   Patient, a 35 year old FEMALE presents to  Emergency   Department on 01/10/22 12:13.       Tetanus status: Last Tdap: Oct 30, 2016      LMP:  NA - male    Chief Complaint: Visit CC: congested, body aches, chills.     Informant:Self   Mode of Arrival:POV         Emergency care given to patient prior to arrival:None    Nursing notes: Pt is an asthmatic who was seen in the ED for cold s/s 3   days ago,  since then she has been nauseaous, SOB, body aches. With   exertion pt at  87% at rest 91%   LOCAL TITLE: H&P_                                                STANDARD TITLE: H & P NOTE                                       DATE OF NOTE: JAN 10, 2022@20:37     ENTRY DATE: JAN 10, 2022@20:37:39             AUTHOR:          EXP COSIGNER:                                 URGENCY:                            STATUS: COMPLETED                         Patient is a 35 year old FEMALE who is being admitted to the Hospital. This patient meets inpatient  level of care because  COVID +, ambulatory hypoxia, moderate  risk with CM, morbid obesity  Patient, a 35 year old FEMALE currently  on FCU was admitted on JAN 10,2022 19:25.The patient is being discharged 14-Jan-2022by
Vaccines given at 10:00 AM at 2 month well visit without problems. On 5/18/01, at 16:00 in the afternoon, pt sleeping in non-moving swing and awoke screaming and went limp, per mom. Pt seen at ER. Alert, breathing normal with ? low O2 sats. Transferred to another hospital where O2 sats were 95% and pt appeared fine. Unknown if vaccine related. Diagnosed with cyanosis
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 52-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (received 1st dose some time in September 2018). On 7th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 8th January 2019, 1 days after receiving SHINGRIX, the patient experienced injection site pain. In January 2019, the patient experienced rash, raised rash, difficulty sleeping and injection site itching. On an unknown date, the outcome of the injection site pain, rash, raised rash, difficulty sleeping and injection site itching were unknown. It was unknown if the reporter considered the injection site pain, rash, raised rash, difficulty sleeping and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The next morning after receiving the SHINGRIX, the patient developed pain and soreness at the injection site. It had been difficult for him to sleep on this arm. The pain and soreness was starting to subside but now the injection site had become itchy. In approximately the last day her husband had developed a rash on the mid to lower part of his back and on the lower part of his stomach. There were at least a dozen spots, some of them raised, on both sides. The rash was not itchy, painful, or sore. The reporter did not consent to follow up. Reporter was unable to provide any additional information.
My menstrual cycle severely impacted. I have had my period no less than twice per month since the 2nd Vaccine, with no more than 21 days in between cycles; Generally there have been 10 days in between periods. The uterine lining is thick, clotty, and the flow is heavy, with significant cramping. None of these are the norm for me, I usually have lighter periods with no cramping.
Site: Redness at Injection Site-Medium, Systemic: rash/redness on upper arm, under arm soreness-Medium
Pt developed jaundice 5 days after second vaccination. TBili was 16 on presentation to hospital approximately 20 days after vaccination and was 25 at the highest. AST and ALT were markedly elevated over 1000. Liver biopsy showed DILI vs autoimmune hepatitis, thought to be more related to AIH. This is a new diagnosis for her. Started on steroids with improvement
Per mom-since the vaccines pt. has had fevers, headaches & generalized weakness.  Just prior to admit.  noted visual problems and gait problems.  3/19/09 Received hospital medical records of 2/13-2/23/2009. FINAL DX: ADEM Records reveal patient experienced intermittent fever, HA, lethargy & irritability x 30 days & 3 days s/p vaccination.  Developed ataxic gait & visual changes 3 days prior to admit.  ID, Neuro consults & LP done.  Initially tx w/IV antibiotics for presumed menigitis.  No steroids & antiobiotics d/c.  Resolved spontaneously & d/c to home.  4/27/09 Case closed as incomplete.  Have not received vaccine records from PCP.  Will reopen should additional information become available.
tested positive for covid; tested positive for covid/Nasal Swab: positive; This is a spontaneous report from a contactable nurse. An 84-year-old female patient received first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration on 05Jan2021 at a single dose for COVID-19 immunization. Medical history included Alzheimer's disease, cough (she has had a cough forever), cellulitis, constipation, dementia, depression, appendicectomy, and right hip replacement surgery. The patient's concomitant medications were not reported. The patient experienced tested positive for COVID on 13Jan2021. The patient underwent lab tests and procedures which included Nasal Swab: positive on 13Jan2021. The reporter was calling for information about administration of the COVID vaccine at an interval greater than the 21 days and recommendations for a patient who tested positive after the first dose of the vaccine. The patient got the first dose of the COVID vaccine on 05Jan2021, She tested positive for COVID on 13Jan2021 and then next time she will be seen and tested will be 15Feb2021. Due to this it seems like they can't give her the vaccine this following Monday because she tested Positive and the Next time, the clinic gets vaccines is on 15Feb2021, Caller asks is that too long of a time frame for the second Dose. Or would they have to start over on 15Feb2021 with another first dose. The First Dose was on 05Jan2021. The Positive Covid Test was on 13Jan2021, it was done by a Nasal Swab. Patient won't be due for another COVID test for 14 days after, she is due for her next COVID test on 27Jan2021. If she is Negative on the 27Jan2021, then she will get her next COVID Vaccine on 15Feb2021. This is non-serious report. The outcome of events was unknown.  Information on the Lot/Batch number has been requested.; Sender's Comments: The patient received the first dose of bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine), on 05Jan2021, and COVID-19 test, including Nasal Swab, positive on 13Jan2021.  No effect of the suspect vaccine could be reasonably achieved to protect from the targeted infection/disease due to the very short time lag.  Instead, the positive COVID 19 test likely represents a pre-existing infection prior to vaccine use.  Further information is needed for full medical assessment.
her son received the Pfizer COVID-19 vaccine last Friday and yesterday her son started vomiting; Headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-healthcare professional), Program ID: (159558). The reporter is the parent.   A male patient received BNT162b2 (BNT162B2), on 20May2022 as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: HEADACHE (non-serious) with onset 21May2022, outcome "unknown"; VOMITING (non-serious) with onset 21May2022, outcome "unknown", described as "her son received the Pfizer COVID-19 vaccine last Friday and yesterday her son started vomiting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of vomiting, headache.   Additional information: Reason for no lot number: of Covid-19 vaccine: Complainant hung up abruptly/transfer incomplete. Expiry Date of Covid-19 vaccine: Unknown. NDC number of Covid-19 vaccine: Unknown. UPC number of Covid-19 vaccine: Unknown. Call was transferred by (withheld) (not clarified) from Customer Service Center for the Pfizer-BioNTech COVID-19 vaccine (CEP ID: 159558) (cep details were not clarified appropriately). Transferring agent stated, had a (withheld) interpreter on the other line. They had a caller on hold and she was a (withheld) and actually what happened was her son received the Pfizer COVID-19 vaccine last Friday and yesterday her son started vomiting and had a headache and she already gave Tylenol (treatment) and now she was really concerned about the condition of her son and she was concerned with the heart, she was concerned with the reading of her son's heart, she said.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt called pharmacy the morning after her flu shot reporting head to toe rash. Pt took BENADRYL & did not help. I referred pt to her doctor. Pt reports NKDA or any other adverse events.
Noted redness of (Rt) deltoid and swelling after receiving TDAP & FLUZONE vaccination.
Nurse administered inadvertent subcutaneous injection; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's COVID-19 Vaccine, and the nurse administered inadvertent subcutaneous injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) for prophylaxis of COVID-19 infection.  On 28 Dec 2020, the pharmacist reported that the nurse administered an inadvertent subcutaneous Moderna vaccine injection to the patient. The patient did not experience any adverse reactions.   No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, nurse administered inadvertent subcutaneous injection, was considered resolved on 28 Dec 2020.; Reporter's Comments: This report refers to a case of Incorrect route of product administration for mRNA-1273 (Lot number: 037K20A). There were no reported AEs associated with this case of Incorrect route of product administration.
Information has been received from a licensed practical nurse concerning a 19 year old female, with no pertinent medical history, who in March 2007, was vaccinated IM with a 0.5 ml first dose of GARDASIL.  There was no concomitant medication.  In March 2007, the patient felt dizzy and lightheaded.  The patient had the symptoms one week after the vaccination.  Unspecified medical attention was sought.  Subsequently, the patient recovered from feeling dizzy and lightheaded.  Additional information has been requested. This is in follow-up to report(s) previously submitted on 9/17/2007. Additional information is not expected.
Since having the vaccine I have had my period for longer, heavier and painful than normal on June 6th, then again on June 26th I spotted for 3 days. On June 27th I had pains in my pelvic area with instense throbbing that started on the right side and then the left. I woke up on June 28th at 2 am with an intense headache and I believe I had had an anxiety attack (never had one before). Then I didn't get my period again until August 8th for 3 days. In September I had started my period on September 4th for 3 days and again on September 21st for 4 days and clotting on the 29th. In addition I have not had a herpes outbreak in sometime (every few years) and since my vaccine I have had 5 outbreaks in September in various locations (upper left thigh, left groin and genital area)
In the evening day after injection when getting in the shower she noticed red blotchy spots on lower upper arm and a red blotchy looking line.  no itching, no warmth, just blothcy red spots.
contacting over uncommon side affect experienced:  mouth tasted like i was sucking on a large handful of dirty pennies for from time of vaccine 4/18 until 4/20 late in the evening when that taste shifted to like i had bit my lip and it was bleeding a little bit type of metallic no more dirty penny taste but still metallic, and by time i had lunch  on 4/21 the taste was gone. want to do due diligence in reporting this bc i know it was an uncommon side affect from what i googled after it didnt go away within a few hours. water seemed to make the metal taste worse could only do flavored water or a fruit juice.  As soon as i got done eating the taste would come back. i used Zyrtec and some peptide stuff to help alleviate the symptoms idk if it worked or not but i tok them starting right after the vaccine when we got home right up tto today bc i figured be afe and o an extra day of it....i was recommended to take them both by a nurse at the fairgrounds bc of my tetnus shot  reaction when they flagged her over to tell her about it. I did not know about the tummy med prior actually having an anti histamine thing in it so that is def good info to know for the future!  i also felt ridiculously tired the day after the shot  w/very little energy it felt and had a super sore arm but that seems to be normal from i've heard from everyone i know who got the shot...not one person had a metal tasting mouth like i had; did not know of the metal taste was even a thing until my husband started goolging and saw that it was very uncommon but harmless, just annoying and no one there said what was normal vs abnormal and my husband had this taste as well for a few mins but he his went away by time our wait time was up and after mine didnt go away by time we got home (2 hr drive) we knew that wasnt right........just want to make sure it gets reported bc it may be more common then what  google had it seem bc ppl dont want to jump thru hoops to report things. my primary gave me the number of the local health dept to call who in turn directed me to this site. and well frankly your forms for filling this out could be better like no where have you asked what site did i go to for this just my docs office info which frankly will do no good bc they didnt want to deal with this. they also advised me to bring my vaccine card in for photocopies when it is done bc they are unsure when the state will be sending that info to them which should also have been directed better at the vaccine site that that is what we are supposed to be doing granted maybe its discussed at the second shot time not the 1st. i will still be getting the second shot. but am not looking fwd to it. i was over all very please with how fast and efficient and kind everyone was at the site.
I had Uvitis of the right eye and I've had 3 rounds of treatment. I have been to the Optometrist multiple times, rhuemotologist. All test have ruled out Uvitis.
ER Triage Note   The patient, a 36 year old FEMALE presents to Emergency   Department on 01/13/22 17:18.       Tetanus status: Last Tdap: Jun 15, 2017      LMP:    Chief Complaint: Visit CC: SOB, Covid +, hypoxia.     Informant:Self   Mode of Arrival:EMS     The patient is a 36 year old FEMALE who is being admitted to the Hospital. This patient meets inpatient  level of care because  COVID W/ Hypoxia .  LOCAL TITLE: CASE MANAGEMENT DISCHARGE FOLLOW UP                 STANDARD TITLE: CASE MANAGER NOTE                                DATE OF NOTE: JAN 18, 2022@07:03:32  ENTRY DATE: JAN 18, 2022@07:03:32             AUTHOR: (Privacy)      EXP COSIGNER:                                 URGENCY:                            STATUS: COMPLETED                           SUBJECT: f/u                                                                Patient discharged following covid with hypoxia
No additional AE reported; a dose of PROQUAD was administered to the patient on 11AUG2022 after experiencing a temperautre excursion.; This spontaneous report has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications and previous drug reactions and allergies were not provided.   On 11-AUG-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), for prophylaxis, with a dose of 0.5 milliliters (ml) (lot number U031560 had been verified as a valid number, and expiration date reported and established as: 06-APR-2023) (vaccination scheme, route of administration, and anatomical site of injection were not reported). The administered dose of the vaccine was stored at a temperature of 18.6 degrees Fahrenheit (F) during a time frame of 30 minutes. There was a previous temperature excursion reported as: 9.8 F for 30 minutes. There was no adverse effect reported.; Sender's Comments:  US-009507513-2208USA005443:MSD US-009507513-2208USA005325:MSD US-009507513-2208USA004963:MSD US-009507513-2208USA005272:MSD
Fever; Side effects; This case was reported by a consumer and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a week after receiving Shingrix, the patient experienced fever and adverse drug reaction. On an unknown date, the outcome of the fever and adverse drug reaction were not recovered/not resolved.   It was unknown if the reporter considered the fever and adverse drug reaction to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced side effects except tiredness. At the time of reporting, the patient had fever and stated that, it has been a week since vaccination.
Cold chills, head ache, dizziness, body pain all over, no energy/tired.
On sunday she developed a rash on her shoulder that looks like poison ivy; itchiness on her wrist; wake her up last night; This is a spontaneous report from a contactable consumer (patient's husband). A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "Husband, calling on behalf of wife, cold transfer, received first dose of the Pfizer BioNTech Covid on Thursday. On Sunday she developed a rash on her shoulder that looked like poison ivy. The rash had since spread to her elbow and wrist. It had been getting better since treating with poison ivy cream, although the itchiness on her wrist did wake her up last night (23Mar2021)". Reported asked that "was this normal; could she get the second dose; and was it a good idea to treat with poison ivy cream, how could they treat it. Outcome of the event rash was recovering whereas other events was unknown.  Information on the lot/batch number has been requested.