chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician assistant and refers to a 55 year old patient of unknown gender. There was no information regarding the patient's medical history, concomitant medications, drug reactions and allergies provided. On 12-DEC-2017, the patient was vaccinated with PROQUAD, therapy type rHA, lot # M044575, expiration date 04-MAY-2018, for prophylaxis (dose and route of administration were not provided). Concomitant therapies included sterile diluent. The administered dose of PROQUAD was stored in the refrigerator from 18-OCT-2017, in temperature of 39 degrees Fahrenheit for 1320 hours (55 days). The call was because of digital data logger. There was no previous temperature excursion. No adverse effect was reported. This is one of a several reports received from the same reporter. Sender's Comments: US-009507513-1712USA009167.
Memory loss; This spontaneous case was reported by a consumer and describes the occurrence of AMNESIA (Memory loss) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product UPADACITINIB (RINVOQ) tablet for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Jun-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started UPADACITINIB (RINVOQ) (Oral) 15 milligram once a day. On 27-Jun-2022, the patient experienced AMNESIA (Memory loss). At the time of the report, AMNESIA (Memory loss) outcome was unknown. Not Provided          No concomitant medications information was reported. No treatment medications were provided.  It was reported that in recent months as of 27 Jun 2022, the patient did mention he had been having memory loss issues.  It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.
Came to ER with cheats pain, shortness of breath, fatigue, nausea, vomiting and head ache. Found to have sinus tachycardia in the 130s-140s. Admitted to rule out myocarditis. Later that day developed fever.
No additional AE.; HCP reporting an improperly stored vaccine was administered to a patient; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 14-SEP-2022, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rHA) (PROQUAD) lot # W019623, expiration date 19-DEC-2023 (dose, route of administration and anatomical location were not provided) for prophylaxis. Administered dose of vaccine experienced temperature excursion of -12.5 degrees Celsius for 1 hour and 45 minutes (product storage error, temperature too high). There were no previous excursions reported. No additional adverse event was reported.
ROTATEQ given at 2 mo on 1/18/16. Parents report that child has abdominal pain, (+) gas, large odorous stools for approximately 48 hours later.
Skin trouble, look like singles, only so spot; pain right armpit; pain right armpit; Right armpit and arm sore/ I got pain again. I can see skin trouble the chest and armpit and arm.; Around right chest sore/ I got pain again. I can see skin trouble the chest and armpit and arm.; This case was reported by a consumer and described the occurrence of shingles in a 52-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ibuprofen (Advil) for pain in arm and chest pain.   In November 2022, the patient received Shingrix and Advil at an unknown dose once daily. In November 2022, less than 2 weeks after receiving Shingrix, the patient experienced shingles, skin disorder, axillary pain, pain in arm and chest pain. The action taken with Advil was unknown. On an unknown date, the outcome of the shingles was unknown and the outcome of the skin disorder, axillary pain, pain in arm and chest pain were not recovered/not resolved.   It was unknown if the reporter considered the shingles, skin disorder, axillary pain, pain in arm and chest pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-NOV-2022 Reporter's comments: The patient had Shingrix shot in the left arm 10 days ago, but the right armpit and arm and around right chest were sore. He had took six Advil a day, it was a little fine, but he stated that if he did not take it, he would get the pain again. He could see skin the trouble in the chest, armpit and arm.  He stated that, it look like shingles buy not too much but only so spot. The patient would called his HCP to get advised to continued the use of Advil for the pain.Less than 2 weeks after receiving Advil, the patient experienced shingles, skin disorder. The reporter had denied to provide further contact details.It was unknown if the reporter considered the shingles, skin disorder to be related to Advil.
Mom called to say her son had developed diarrhea, vomiting and fever - at 4AM 6-7-11. I administered vaccine HPV, and meningitis on 6-6-11. Mom was told if fever higher than 101, vomiting x 6 times - diarrhea x 6 stools take to family physician or ER.
Was given Friday Sept 18, still sore, sharp pain up neck to glands under ear-still some pain Tuesday Sept 22-injection site-bruised.
Has had irregular menses since covid vaccine in January. After getting the Vaccine she  missed her  menses in February and March , she had a very light menses in April, then a very painful very heavy menses in May, then skipped her menses in June and July. In Aug menses were finally back to normal.
Shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (First case of shingles occurred on 29th April 2019).   On 13th February 2019, the patient received the 1st dose of Shingrix (intramuscular). On 23rd September 2021, 953 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and experienced second case of shingles. The second case of shingles was not yet resolved as it recently happened, but it was being treated. The patient did not get the second dose yet due to shortage of Shingrix in 2019 and pharmacy forgot to call her back. The reporter did not have lot number, expiry date, dosage of the first dose of Shingrix, and did not know if administered in left or right arm. The reporter gave a consent to follow-up with HCP. However, she does not have full mailing address, fax number, and email address to health care professional. The reporter consented to follow up. This case has been linked with case US2021AMR202745, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021202219:same reporter US-GLAXOSMITHKLINE-US2021AMR202745:same reporter
Pt. is a 92 year old male who resides at an assisted living facility for the past 2 months.  He has dementia but reportedly is oriented to self and place at baseline.  He is not currently able to give a reliable history.  Per ER report, the patient developed lethargy and shortness of breath and tested positive for COVID yesterday.  He worsened fairly quickly and was found to be hypoxic today, and was transferred to the ER.  He had an O2 sat in the low 80s on room air, and was on NRB when he arrived with sat of 95%.  Oxygen has since been turned down to 4L with sat in the low 90s.  Patient is having a productive cough.  He has received his primary COVID vaccine series less than 6 months ago, therefore has not had a booster yet.  He is not complaining of any chest pain.  His troponin is elevated but EKG without acute ischemic changes.  His pro-BNP is also markedly elevated at 29K.  He was administered 40 mg IV Lasix in the ER, and admission requested.    I contacted his daughter at the number provided on the ace sheet.  We discussed treatment plans, and she confirmed patient has DNR orders.  Her husband passed away yesterday, and she requests that we contact her brother as the primary contact for her dad during the remainder of the admission.  1/20/2022: DISCHARGE: Acute hypoxic respiratory failure -Initially requiring supplemental oxygen, now keeping sat >90 on room air -MAT protocol    Pneumonia due to COVID-19 -Continue dexamethasone (may have started yesterday) 1/10 - on remdesivir day 4/5. Will need to monitor renal function and LFTs closely. Both mildly abnormal but do not meet criteria for withholding the medication at this time -Considered tocilizumab or baricitinib if worsening, but down to 2 L and now room air  -OK to truncate RDSV when improved and no longer requires Dex off oxygen    Acute on chronic diastolic heart failure  CXR looks more PNA    CKD stage III -Monitor renal function closely with meds as above    Elevated troponin, type 2 NSTEMI CAD -started aspirin and statin -Echo noted -Per family, no invasive procedures    Hypertension -Continue home metoprolol, amlodipine, ramipril    Hypothyroidism -Continue home levothyroxine    Dementia -Complicates care -Pt's daughter is POA but she requests we contact her brother to provide updates, as her husband passed away 1/16       Dysphagia, high risk for aspiration, made NPO - son describes this as a chronic issue, he thinks they WOULD want a feeding tube if felt he could survive this and get stronger -NPO for most of 1/18, repeat eval indicates swallowing ok, diet ordered       Son updated 1/19  He agrees needs to get back asap and will arrange that today
Extreme itching and swollen arm at injection site. Took a Benadryl tablet and used topical Benadryl itch cream. Itching is now occasional on third day but arm still swollen.
Based on the additional information received on 25 June 2015, this case became medically confirmed. Initial unsolicited report received from a Non-healthcare professional on 17 September 2014. This case is a part of cluster of 12 cases (same reporter, vaccine and vaccine lot number) and is linked to case numbers 2014SA129888, 2014SA129919, 2014SA129922, 2014SA129926, 2014SA129934, 2014SA129941, 2014SA129950, 2014SA129951, 2014SA129956, 2014SA129960 and 2014SA129963. A female patient, whose age was not reported, had received an intramuscular dose of FLUZONE QIV, (batch number UI158AA, dose, dose in series and site of vaccination was not reported) on 15 September 2014. The patient's illness at the time of vaccination and pre-existing physician diagnosed allergies, birth defects and medical conditions were unknown. The patient's concomitant medications were not reported. Any other vaccination within 4 week of vaccination was unknown. On 16 September 2014, one day after vaccination, the patient experienced achy, congested and had a slight fever. Laboratory investigations and corrective treatment was not reported. At the time of this report the outcome of event was unknown. Documents held by sender: none. Follow-up information received from a healthcare professional on 25 June 2015. It was reported that the patient had received the vaccine in Left deltoid and this was the first dose for the year. The patient had recovered 3 to 4 days later on an unspecified date. Documents held by sender: none.
Pneumovax 5/11/05 lost energy 1 hr after shot, then moderate edema/redness/tenderness whole R upper arm. Saw 5/12 and improving.
Parent returned to office with child on 6/12/08.  Childs L upper arm reddened swollen & tender & warm to touch.  Ice pack to area & instructions given to apply ice pack for 15 min. & give TYLENOL.
HEADACHE; FATIGUE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight was 135 pounds, and height was 63 inches. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 202A21A, expiry: UNKNOWN) dose was not reported, administered on 10-APR-2021 14:00 for prophylactic vaccination. No concomitant medications were reported. On 11-APR-2021, the subject experienced headache. On 11-APR-2021, the subject experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and fatigue on 13-APR-2021. This report was non-serious.
High blood pressure, Insomnia, vision problems, arthritis, back pain, left knee pain. information received from VAMC"no electronic or paper records of this patient for dates requested."
Extremely achy; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Extremely achy) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced PAIN (Extremely achy). On 27-Feb-2021, PAIN (Extremely achy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications reported.  Treatment medications was not provided by the reporter
Hearing loss, severe tinnitus, pain, discomfort, fullness/pressure in both ears, fluid buildup(?). After additional time, contacted primary physician, assuming some type of ear infection, treated with Avelox antibiotic starting approx. 10/26/2005 for approx 7 days. Little relief. Then went to ear specialist, who put me on 9 day course of Prednisone started approx 11/11/2005. DID get some relief during treatment, but symptoms returned after finishing the Prednisone. Per follow up 2/28/2006: After approximately 9-10 weeks the seevere inflammation/congestion, especially in left ear DID subside somewhat. Maybe as a result of the 3 courses of rednisone and decongestions. Hearing test showe additional permanent hearing loss. Not sure what to do next. Also tinnitus is much worse 24x7. I saw in the news that Manufacturer was trying to get Flumist approved for children under 5 years old. I think this is a very bad idea. And flumist should not be administered to anyone with any history of ear problems, no matter how mild. Also don't forget that young children probably cannot describe post vaccine ear problems easily. You could only determine that from pre and post vaccine administration ear/hearing tests. That is not likely even to occur, except by chance. Don't approve for young children.
22AUG(5 mom phoned clinic stated pt was in clinic for vax 7AUG95 & was taken to hosp w/hives & swelling on lt leg 11AUG95; (area of swelling 1/2x 1 1/2
This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored VAQTA lot number N017094, expiration date 31-AUG-2018 (dose and route was not reported) for prophylaxis. No adverse effect was reported. Temperature: 9 grades Celsius to 25 grades Celsius "(10.1 C)". Time frame: 1 hour and 56 minutes. There was no previous temperature excursion involved. This is one of several reports received from the same source. Sender's Comments: US-009507513-1710USA003169: Original Case: 1710USA003115, US-009507513-1710USA003166: Original Case: 1710USA003115, US-009507513-1710USA003167: Original Case: 1710USA003115, US-009507513-1710USA003168: Original Case: 1710USA003115, US-009507513-1710USA003164: Original Case: 1710USA003115, US-009507513-1710USA003115: Original Case: 1710USA003115, US-009507513-1710USA003165: Original Case: 1710USA003115.
not feeling well; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/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: MALAISE (non-serious), outcome "unknown", described as "not feeling well".  Additional information: The reporter mentioned that her parents were scheduled to receive their second dose but they would not be able to get it since they were not feeling well.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021444910 same suspect drug and similar event on different patients
On 9/21/22 I had my 5th covid vaccine- booster in my left arm. I had the usual arm soreness for 2 days. On day 3, my left arm was itching a lot. Prior to this day, a few days ago I had mosquito bites but they went away and now this itching has taken place after thee vaccine. Today is Oct 3 and I am still itching. I contacted my doctor a few days ago to express my concern that this had to do with the booster. He said just to use a cream he had prescribed for bites in the past. At that point it was 9 days of itching  and no relief. As of today, still itching and there are no bug bites. I think this is related to the booster. Someone else I know had this issue but she went to urgent care as she had rashes and ended up with sepsis. She too had bug bites.
She got her vaccine, her arm swelled a little bit and then feeling okay.   She then got terrific headaches and started to itch and then gradually worsened.  She took Benadryl and then Zyrtec.  Went to her doctor who put her on some prednisone and some other pills and keeps getting worse and worse.  She saw her allergist who said that he noticed that she is scratching and put her on some medicine and has a FU this week.  She was going to get Dupixent shot.  Her doctors are trying to find a solution to her itching, has a prescription to pick up.  She has FU's this week with her PCP as well.  She continues to have headaches.  She had COVID in January.  Has TMJ and has an ENT appointment tomorrow.    She thinks that maybe her rash is due to previous shingles that she had gotten about 6 years ago.    Her doctor told her not to get anymore vaccines.
This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 70-year-old female patient who received SHINGRIX (batch number 4492P, expiry date 25th April 2020). Concomitant products included ZETIA. On 1st May 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In May 2018, less than a week after receiving SHINGRIX, the patient experienced swelling arm and pain in arm. On an unknown date, the outcome of the swelling arm and pain in arm were not recovered/not resolved. The reporter considered the swelling arm and pain in arm to be probably related SHINGRIX. Additional details were provided as follows: The patient's concomitant medications included PROAIR (not specified). At 11:15, the patient received SHINGRIX in the right deltoid. The patient had sore and swollen arm about 5 inches below the injection site where she received SHINGRIX.
Apparently, the adverse event is that Moderna Covid 19 vaccine is not licensed for use on minors under the age of 18.  We received an email from the Police Department inviting the immediate family of first responders age 16+ to sign up and get the vaccine. We did so, and our son was vaccinated with the Moderna Covid vaccine and is only 17. We are now UNABLE to get him fully protected because we are told he can't have his second dose since he's not 18. We are unable to opt for the Pfizer vaccine, which is licensed for 16+, because you can't mix the brands apparently.  Because of this sloppy mess, our son will now be without protection from Covid 19 until some time in the future- whenever some scientists decide it is safe for people who got a single dose of Moderna to now get both doses of Pfizer-- or when he is 18 in a year from now, and can take the Moderna vaccine again. This is very frustrating.
Patient noticed swollen erythematous area of approximately 3 inches in diameter on 2/15/2010 after it started itching. Patient contacted pharmacy and was instructed to take Benadryl 25 mg PO PRN, and apply warm compresses to the area.
I started not feeling well in late February and early March 2021. I also got really sick in the beginning of June 2021. My symptoms were feeling faint, experienced SOB, dizziness and fatigue. I went to a clinic where an EKG was performed. I was told I had a "failed EKG". The EKG showed depression line. I was then sent to the hospital where lab work was performed. I was told to follow up with a cardiologist. The cardiologist told me that I had an abnormal EKG and he does not know why behind my abnormal results or failed EKG. As of today 06-3-2021, I continue to feel faint, fatigue, SOB and dizzy at times.  I am scheduled to have an echo test in one week from today. I do not have lot# to provide today.
localized pain, redness, swelling in rt deltoid area;body aches & pain;tx ice, pain med;
A week and two days later I noticed a red spot where the shot was. It is a rash the size of the palm of my hand and it is a little warm
Narrative:  Fully vaccinated, admitted for infected/necrotic foot infection, found to be COVID positive accidently
Headache, Myalgia, Arthralgia, Fever, NauseaVomiting, chills/ fatigue Narrative:
Patient experienced tachycardia after both the first and second dose about 30-45 minutes after the vaccine. The initial episode lasted about 20 minutes before resolving on its own. Today's reaction lasted about 30-40 minutes before resolving on its own but then returned at 1720 this evening. Patient's symptoms improving on their own and without intervention. HR currently 107
Approximately 5 minutes after receiving both vaccinations patient had what father, an MD, described as focal seizure.  Patient went rigid and lost consciousness briefly.
Fever of 102.5--gave medicine, he felt lethargic, had chills and had fever for 24 hours--this is following DTAP shot.
red ring appeared around the injection site that measured 2-3 inches around; sore arm; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site erythema and pain in arm. On an unknown date, the outcome of the injection site erythema and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received first dose of Shingrix 6 to 8 weeks ago of the reporting date and experienced a sore arm and a red ring appeared around the injection site that measured 2 to 3 inches around. The soreness and redness had resolved. She had not received her 2nd dose yet.  No other information was provided. The reporter did not consent to follow-up.