chrisvoncsefalvay/vaers-outcomes huggingface dataset:
hands were swollen, but didn't look swollen; they're itchy; mosquito bite like rash over his forearms, but they were internal instead of external like; a welt on my belt line/another one on my hip; bones started to ache; fever; This spontaneous case was reported by a consumer and describes the occurrence of BONE PAIN (bones started to ache), URTICARIA (a welt on my belt line/another one on my hip), PERIPHERAL SWELLING (hands were swollen, but didn't look swollen), PRURITUS (they're itchy) and RASH (mosquito bite like rash over his forearms, but they were internal instead of external like) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Oct-2021, the patient experienced BONE PAIN (bones started to ache) and PYREXIA (fever). On 20-Oct-2021, the patient experienced URTICARIA (a welt on my belt line/another one on my hip). On 21-Oct-2021, the patient experienced PERIPHERAL SWELLING (hands were swollen, but didn't look swollen), PRURITUS (they're itchy) and RASH (mosquito bite like rash over his forearms, but they were internal instead of external like). At the time of the report, BONE PAIN (bones started to ache), URTICARIA (a welt on my belt line/another one on my hip), PERIPHERAL SWELLING (hands were swollen, but didn't look swollen), PRURITUS (they're itchy), RASH (mosquito bite like rash over his forearms, but they were internal instead of external like) and PYREXIA (fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication were provided. No treatment information were provided.
patient reported experiencing tingling sensation down on left arm after getting Pfizer vaccine. She has a history of fibromyalgia. Patient was in observation area for 30 minutes without resolving the symptoms to baseline. Followed up with patient, after one hour, she still experiences the symptoms. Patient was told to follow up with urgent care or clinician if symptoms do not resolve.
Patient received covid 19 moderna vaccine on 3/6/21 and 4/5/21. Patient presented to BWH ED on 9/29/21 with chest pain and fever. Troponins 65 -> 35-> 31. ECG no ischemic changes. Noted to have elevated CRP 85 and ESR 23 and NT-proBNP 676. Cardiac MRI showed evidence of nonspecific, but diffuse myocardial inflammation without morphologic LV changes or dysfunction. Patient was appropriately treated and discharged.
Patient had an initial injection site reaction blister, as time when on, the blistering/rash continued down her arm.
HEAVY MENSTRAL CYCLES, SPOTTING AND CRAMPING THROUGHOUT MONTHS FIVE MONTHS AFTER VACCINE
Redness/'hard knot' (5X5cm), hot to the touch at injection site, pink and swelling around injection site (10X15cm), pain in arm running down into hand.
Patient received Td and varicella vaccines and within 1-2 minutes he fell to the floor in the waiting room, jerk a little, and was then aroused within 30-45 seconds.  Patient bumped head on chair base, no injury noted; no complaint of pain stated.
Information has been received from a nurse, referring to a patient of unknown age. Information of concurrent condition, medical history and concomitant therapy was not provided. On 27-NOV-2018, the patient was inadvertently administered a dose of M-M-R II (strength, route were unknown; lot # M045402 and expiration date 14-NOV-2018) which was expired (expired product administered) for prophylaxis. No adverse effects reported.
72 hours later (feb 25) my gums became very sore  and bloody and patchy and my teeth ached. feb 26 i was exhausted and blisters appeared on my lips and gums got worse and i stayed in bed exhausted. feb 27 i went to urgent care and they said probably just a reaction to the vaccine and mouth will clear up feb 28 mouth got worse and my torso developed a rash. i took one amoxycillin that night around 1100pm, worried that i had some infection in my gums as in periodontitis mar 1 i woke with a 103 degree fever and went back to urgent care where they took some blood tests for  mono and for strep. then they sent me to the dermatologist, the doctor who ordered more blood tests (3 diffferent vials) took a biopsy of the rash. The doctor thought is that it may be a herpes simplex 1virus that  has activated itself because my immune system was compromised by the covid shot. not usre about body rash. today mar 1 my rash is a LOT worse on torso and very itchy. i am taking valacyclovir 3 times a day and rinsing mouth with lidocaine hydrochloride viscous solution. we are still awaiting lab results.
patient received her covid vaccine per her record: 1/3 and 1/24/21. Patient presented to Facility 4/20/21 diagnosed with COVID, patient died 4/23/21 due to hypoxic respiratory failure/ bilateral pneumonia due to covid.
aft vax pt exp slight stuffy/runny nose day later fuzzy all day/cold like sx. night congested, not sleep, diarrhea, loss appetite, days later spot on neck, quite red, hot to touch, 6spots 1in rectum irritated pt, bled, boil like see comment. Information has been received from a physician concerning a 1-year-old male patient who on 06-FEB-1998 was vaccinated with one dose of VARIVAX. Concomitant vaccination that same day included DTP. That same day, the patient experienced a "slightly stuffy runny nose (thought to be drooling)." On 07-FEB-1998 he was "fuzzy all day and had cold-like symptoms". It was reported that by that evening, "he was very congested and could not sleep at night." On 08-FEB-1998 the patient was seen by a pediatrician because "he was quite congested". The patient was prescribed Biaxin 250 mg "which that patient did not finish because it gave him such terrible side effects as diarrhea, loss of appetite, etc". It was reported that "he hated it with passion no matter how it was given to him". On approximately 24-FEB-1998 he develop the first spot on his back. It was the largest becoming quite red, hot to the touch at night when he slept on it. This spot eventually scabbed over and was the last to disappear". On 25-FEB-1998 a second spot appeared on his neck. By approximately 27-FEB-1998 the patient had three more spots which appeared on his abdomen. It was reported that three never seemed to bother him and never scabbed over but just faded away. On 28-FEB-1998 an additional spot appeared in the patient's rectum which really irritated him and it bled a tiny bit when using wet wipes during diaper changes. By 01-MAR-1998 the spot on his back was still pretty bad looking and his grandmother thought it resembled a boil and should be checked in case he was fighting something internal. On 02-MAR-1998 the patient was seen by a physician who did not consider chickenpox since the patient had the vaccine and the spots looked remarkably better. The physician thought the spots may have been just bug bites but prescribed Cefzil 250 mg for fluid in the ear which would also clear up anything else he might have had. The patient's father was reported as well (WAES 98031937). Follow-up information from a physician indicated that the patient also developed a varicella-like rash. On an unspecified date the patient recovered. No further information is available.
heart rate would drop to as low as 30 then bounce up in the 90's; This is a spontaneous report from contactable nurse (Patient). A 56-years-old non pregnant female patient received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE; Solution for injection; lot number: ER 8729), via an unspecified route of administration on 06Apr2021 at 16:00(at the age of 56-years-old) into Arm Left as a single dose for COVID-19 immunisation at Pharmacy or Drug Store. Medical history included Scarlet fever age 18, spondylolisthesis s/p fusion (all from an unknown date and unknown if ongoing). The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 14Apr2021 at 08:15, the patient experienced heart rate would drop to as low as 30 then bounce up in the 90's. It was reported that: "My entire life my heart rate has always been in the 80 s. I did not experience any of the common side effects following either vaccine but about a week after 1st dose, I noticed my heart rate would drop to as low as 30 then bounce up in the 90 s. My galaxy watch has captured multiple events like this daily every day since. This never occurred prior to receiving your vaccine". No treatment given for the event. Seriousness criteria assessed as Disability. The outcome of the event was not recovered.  Information on Lot/Batch number was available. Additional information has been requested. ; Sender's Comments: Based on temporal relationship there is reasonable possibility of causal association between the reported events  arrhythmia and the suspect drug.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received doses of the Moderna COVID-19 vaccine after its beyond use date from different vials), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses after its beyond use date and previously affected by a temperature excursion), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 26-Jul-2022 and vaccine was administered on 01-Sep-2022) and NO ADVERSE EVENT (No adverse event) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011b22a) for COVID-19 prophylaxis. No Medical History information was reported. On 01-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received doses of the Moderna COVID-19 vaccine after its beyond use date from different vials). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses after its beyond use date and previously affected by a temperature excursion), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 26-Jul-2022 and vaccine was administered on 01-Sep-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received doses of the Moderna COVID-19 vaccine after its beyond use date from different vials), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses after its beyond use date and previously affected by a temperature excursion), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 26-Jul-2022 and vaccine was administered on 01-Sep-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients received doses of the Moderna COVID-19 vaccine after its beyond use date from different vials), PRODUCT TEMPERATURE EXCURSION ISSUE (Patient received doses after its beyond use date and previously affected by a temperature excursion) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator 26-Jul-2022 and vaccine was administered on 01-Sep-2022). Patient received the second booster dose. No concomitant medications information was reported. Number of doses/vials 2 doses from 2 different vials. Date the vial was initially stored in the refrigerator and initially thawed was reported as July 26 2022. No treatment medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2022-638952, US-MODERNATX, INC.-MOD-2022-638948 (E2B Linked Report). Sender's Comments: US-MODERNATX, INC.-MOD-2022-638952: US-MODERNATX, INC.-MOD-2022-638948.
DAY ONE: Initial onset was first chills within 22 minutes of shot > then sore arm > headache started 4:30 pm > fatigue at 6:30 pm  that worsened over hours > nausea with mini reflux vomit moments x5 at about 7:30 pm > went to sleep for night | NEXT DAY: added symptoms left side facial tingling, continued arm pain and milder other symptoms except fatigue worse | THRID DAY: late in the day, finally relief of most symptoms
This child received vax in the morning of 02/04/00, at noon he developed a fever of 103 F.  At 23:30 he had an episode of limb shaking (less than 5 minutes). On 02/05, he presented to the ER at 01:40 with fever, vomiting, and "shaking spells."  He was discharged home on acetaminophen or ibuprofen for fever.
Information has been received from a Licensed Vocational Nurse referring to an unspecified number of patients of unknown age and gender. There was no medical history or drug reaction/allergies reported. On unknown dates the patients were vaccinated with improperly stored doses of PROQUAD (Merck) (lot# L005297 with expired date 17-AUG-2016, dose and route were unknown). No concomitant medication was provided. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
I had normal listed side effects the day after (fatigue, nausea, and a little brain fog). I mentioned to the pharmacist today that a few days after the first shot, I had cramps in both my calf muscles (worse in right) that felt a little like a charley horse but nothing helped - I exercised (I'm a fitness instructor), stayed hydrated and had electrolytes,  took ibuprofen and rolled out the muscle and nothing changed it. I woke up three days later and it was gone. No warmness or swelling, just felt like my muscle had been shortened.
Received second dose of vaccine subcutaneously; A spontaneous report was received from a nurse concerning a 45-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and it was noted that she received second dose of vaccine subcutaneously/ Incorrect route of product administration.  Medical history or concomitant product use was not reported.  On 08 Feb 2021, the patient received her first of the two planned doses of mRNA-1273 (batch number: 012L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 08 Mar 2021, the patient received her second of the two planned doses of mRNA-1273 (batch number: 010M20A) subcutaneously in the left arm. It was reported that the injection was given on the tender surface of the skin, not muscle. Treatment information was not provided.  The action taken with mRNA-1273 in response to the event was not applicable since the patient took her second dose already.  The outcome of the event was resolved on 08 Mar 2021.; Reporter's Comments: This report refers to a case of incorrect route of product administration for mRNA-1273, lot # 012L20A with no associated AEs.
Patient reported flu-like symptoms, including full body aches, chills for several hours at a time, and hot flashes. She has a "large" red spot/bump further down her arm below the injection site that is hot to the touch, and a second spot forming closer to the injection site (between the first spot and the injection site, and to the right). She also reports pain down her arm, and her arm feels heavy/hard to lift. Patient notified pharmacy 2 days after administration of vaccination, pharmacist advised patient to call doctor to be seen for evaluation. Patient was seen by nurse practitioner who diagnosed symptoms as a regular reaction to a vaccination. Patient was prescribed CELEBREX daily for 14 days and betamethasone cream twice daily for 14 days, and told to take BENADRYL OTC for rash. Patient to follow-up with NP if reaction worsens or doesn't get better.
This is an initial report of a Pregnancy, received on 06Nov2014, for FLUBLOK; a 33-year-old female who received FLUBLOK Intramuscular on 06Nov2014. On Day 0 (06Nov2014), the same day as received FLUBLOK (Lot #: unknown), the subject contacted the call center stating that she received FLUBLOK while pregnant. The subject reported that she discussed getting FLUBLOK with both her obstetrician and her allergist and all stated it was acceptable to received FLUBLOK. The subject noted that she is due in approximately 03Jul2015. Medical history included asthma. No information on previous pregnancy history was provided. Concomitant medications included PULMICORT for asthma, levothyroxine for thyroid, and multivitamin for an unknown indication. Causality information was not provided. Since FLUBLOK was a single dose (unable to confirm), action taken, outcome, De Challenge and ReChallenge have ben reported as Not Applicable.
The vaccine did not prevent shingles as intended; persistent strain of herpes zoster or shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information on the patient's concurrent conditions, medical history or concomitant therapy was not reported. On or about 12-NOV-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot# and expiration date were not reported) at a pharmacy, for routine adult health maintenance and for the long-term prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster or shingles. On or about 11-MAR-2016, patient was treated by a physician for the onset of a severe vesicular rash, which was diagnosed as herpes zoster. Patient was prescribed valacyclovir hydrochloride (VALTREX) for management of his painful symptoms and chronic pain. As a direct and proximate result of the zoster vaccine live (ZOSTAVAX), and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. The reporter considered herpes zoster and vaccination failure to be related to Zoster Vaccine Live (ZOSTAVAX).
I had a mole removed on 2/11/2023. On 2/13/2023, the site became infected. There was brownish discharge that increased in subsequent days. I called my doctor's PA, who prescribed me cefalexin. This didn't clear up the problem, so the doctor who removed the mole prescribed me another round of cefalexin. Altogether, I took cefalexin for ten days. I took probiotics during that period. However, a week after I finished taking the cefalexin, I developed gastrointestinal issues (nausea, headache, intermittent diarrhea, intermittent dizziness). I went to an urgent care. While I was at urgent care, I underwent a urine test, and the results were normal. They then prescribed me an anti-nausea pill, which I am still taking. At the time of this writing, I think that I am recovering. I am able to work and go about my normal activities, though the issues I've had have affected my ability to do my tasks at my normal level. I am in the midst of treatment right now.
Case number PHEH2014US024272, is an initial spontaneous report received from a nurse on 02 Dec 2014, with a follow up report received from nurse on 21 Jan 2015. This report refers to a 57 years old female patient. Her medical history was not reported. Concomitant medications were none. The patient had tolerated the vaccines well in the past. She was vaccinated with FLUVIRIN (batch number: 14511P, expiry date: Mar 2015) intramuscularly into left deltoid at a dose of 0.5 ml on 05 Nov 2014. Nurse reported that PFS of FLUVIRIN was stored at 49 degree F for 1 hours and 15 minutes. The patient did not experience any adverse reaction due to the maladministration. No further information was provided. Follow up report received from nurse on 21 Jan 2015: Updated site of vaccination and reporter comment.
There were no reactions or adverse effects. This vaccine was given to a 6 month old who did not need the vaccine until she was 12 months of age.
Tested positive for COVID-19; Tested positive for COVID-19; This is a spontaneous report from a contactable consumer  The same reporter reported  for four  different patients   A 9-decade-old patient of an unspecified gender received bnt162b2 (BNT162B2) unknown dose number , 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 was tested positive for covid-19 (medically significant) on an unspecified date and ended up quite sick with outcome of unknown.  Course of the event. I received a phone call from my friend that her 2 yr old granddaughter tested positive for Covid. They visited me on 27Jul2021. Her, and the mother had both been vaccinated with the Pfizer vaccine in Feb2021. However they both tested positive for COVID. I then self-quarantined until I tested 5 days later on 01Aug2021. My test came out Negative. My friend also reported to me that another in their family who is in their 80's also Pfizer vaccinated, tested positive covid and ended up quite sick.  Information about the Lot/batch number has been requested.
I started getting Tinnitus in June 2021. I don't hear it an one specific ear, just in my head. I haven't been able to sleep because it keeps me awake. I have Insomnia because of it. It sometimes takes over my life. I don't want to be around people or talk on the phone. I can't seem to get any kind of help for it. Nothing has worked. I had a machine that was supposed to help with the Tinnitus but it was to expensive so I had to send it back. I also tried physical therapy and acupuncture. The ENT doctor wanted me to get a special hearing aid to change the sound of the tinnitus but I could not afford that either. Also, the right side of my face is swollen all the time. This has also been since June. I have been to the ER for the Tinnitus and from there they referred me to a Neurologist. More recently I have been experiencing stomach issues including diarrhea.
6m-4yr doses given to 5 year old patient,  Correct doses given within 10 minutes.
Client stated she had a slightly "swollen tongue", denied any respiratory difficulties, was alert and orientedX3.  Benadril 25 mg PO was given.  Symptom went away and stated she felt "just fine", denied any respiratory difficulties.  Was observed for 30 min and left unassisted.
Skin Inspection:  R anterior thigh:  erythematous, maculopapular, circular rash, swollen, TTP, mild warmth, nonfluctuant.  9x11 cm diameter.  No pustules, vesicles, or drainage. Borders outlined w/marker for parental monitoring of rash for enlargement.  No other rash noted on extremities or trunk.
Suicidal ideations began immediately.  Suicide by gunshot completed July 27, 2021