chrisvoncsefalvay/vaers-outcomes huggingface dataset:
LOWER BACK STIFFNESS; ITCHY; LEFT FOOT PAIN; LEFT ANKLE PAIN KNEE PAIN AND JOINT PAIN; This spontaneous report received from a patient concerned a 48 year old female. The patient's weight was 200 pounds, and height was 65 inches. The patient's concurrent conditions included crohn's disease, alcoholic, and non-smoker, and other pre-existing medical conditions included the patient had no drug drug abuse or illicit drug use. The patient's mother had history of blood clots due to cancer and chemo. The patient experienced burning in mouth, redness face, stomach pain and tenderness when treated with clarithromycin, clindamycin, metronidazole for drug used for unknown indication, and itchy rash when treated with oxycodone for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805018, expiry: 09-JUL-2021) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. Concomitant medications included paracetamol for drug used for unknown indication, and mesalazine. On 01-APR-2021, the subject experienced left foot pain. On 01-APR-2021, the subject experienced left ankle pain knee pain and joint pain. Treatment medications included: ibuprofen. On 02-APR-2021, the subject experienced itchy. Laboratory data included: Antibody test (NR: not provided) negative. On 20-APR-2021, Laboratory data included: Antibody test (NR: not provided) negative. On MAY-2021, Laboratory data included: Ultrasound Doppler (NR: not provided) Negative for veinous thrombosis blood clots. On 03-MAY-2021, Laboratory data included: Antibody test (NR: not provided) negative. On 17-MAY-2021, the subject experienced lower back stiffness. On 20-MAY-2021, Laboratory data included: Antibody test (NR: not provided) negative. On 09-JUN-2021, treatment medications included: famotidine/ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itchy on 03-APR-2021, and had not recovered from left foot pain, lower back stiffness, and left ankle pain knee pain and joint pain. This report was non-serious. This case, from the same reporter is linked to 20210664067.
2 year old female, developed vesiculopapular rash on right interior thigh/Tibia and feet, with refusal to walk. Presumed shingles was treated with acyclovir X 5 days. Rash resolved completely in about 1 week with restoration of walking. No history of chickenpox.
This spontaneous report as received from a healthcare worker refers to a 9 weeks old patient of unknown gender. The patient's relevant medical history, current conditions and concomitant medications were not reported. On 06-NOV-2015 the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) lot # L008053, with an expiry date of 30-NOV-2016, orally (incorrect product storage). The vaccine was administered at public health clinic or hospital with public funds. No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
Patient called the pharmacy stating that she was not feeling very well, had body aches, fever, and possible chest pain.  Told patient that this sometimes happens with vaccinations and that she could use some Tylenol to help with the fever and chills.  Also instructed her to call her doctor and let them know what was going on, just to be safe.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Oct2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 67 years, in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 13Apr2022 as dose 4 (booster), single (Lot number: FK9895), in left arm for COVID-19 immunisation; BNT162b2 (BNT162B2), on 25Feb2021 as dose 1, single (Lot number: EN6201), in left arm, on 25Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 14Oct2021 as dose 3 (booster), single (Lot number: FH8027), in left arm for COVID-19 immunisation. The patient's relevant medical history included: "ITP" (unspecified if ongoing); "Osteoperosis" (unspecified if ongoing); "Erythrocytosis" (unspecified if ongoing); "Known allergies: Sulpha drugs" (unspecified if ongoing); "Known allergies: sulfites in wine" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of vaccination failure, COVID-19.
I have endometriosis and my periods are heavy with painful cramps first 2 days and my period is done by the 4th day.  I take aleve a day before my period which helps with my cramps.  My last period started April 9th and I am still on my period today April 15th. I had heavy bleeding and blood clots the size of quarters for the first 5 days. The aleve didn?t seem to help and my pain level was at a 10, I would pass out from the pain. My period usually last 4 days and I am on day 7 and still bleeding, but not experiencing any cramps. I?ve read that Covid effects the blood clotting process and also read other women are experiencing heavier menstrual cycles after their covid shot. I also read that moderna didn?t study any side effects related to the menstrual cycle.  I have an appointment today (April 15th) to get my second shot. I am not sure if I should get the second shot, due to the amount of clots I had.
C/o tingling left arm/shoulder 15 minutes after injection. Then increased tightening left side neck and numbness of neck and jaw with extension from her ear to nose. Felt some tightening of chest on 3/4/21 at noon. took benadryl. Majority of numbness subsided on Friday 3/5 however still having numbness at hairline on opposite side of face.
Initial case of medication error was received  from a healthcare professional on 12 Feb 2014. A patient whose demographics detail including (gender and age) medical history and concomitant medication were not reported received a dose of FLUZONE on an unspecified date (route, dose, site and batch number was not reported). It was reported that on an unspecified date FLUZONE had been administered to the patient after it was stored improperly below recommended temperatures (FLUZONE reached 1 degree Celsius for 72 hours on 29 separate occasions in two month period). No information regarding adverse event was reported. Laboratory investigations and corrective treatment were not reported. At the time of report outcome of event was unknown . List of documents held by sender: none.
Vesicular rash, dermatomal pattern (L) trunk developed 7/18/12 after ZOSTAVAX 7/16/12.
Information has been received from a physician concerning her 11 year old Asian daughter with no allergies or medical history who on 21FEB1996 was vaccinated in the arm with a 0.5ml first dose of varicella virus vaccine live. There was no illness at the time of vaccination. The reporter indicated that, on an unspecified date, the patient's body was covered with lesion. No hospitalization was needed. No further information was provided.
Within 1/2 hour of receiving Twinrix, patient presented to doctor's office in anaphylaxis. Given epi 1:1000 times 2, 15 minutes apart. Also Benadryl 50mg PO. Did not respond. To Er where treatment with IV Benadryl and steroids. Discharged and readmitted 2 hours later; started in IV steriods and H, H2 blockers. Observed overnight. Discharge is today 3/14/03.
L upper arm with redness and mild inflammation half dollar size.  Pt with fever last night.  Treatment with Benadryl 50mg TID and warm compresses.  Follow up tomorrow.
COVID 19; Lack of Efficacy; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Feb-2022 and was forwarded to Moderna on 03-Feb-2022.    This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (COVID 19) and DRUG INEFFECTIVE (Lack of Efficacy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 038A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 26-Dec-2021, the patient experienced COVID-19 (COVID 19) and DRUG INEFFECTIVE (Lack of Efficacy). At the time of the report, COVID-19 (COVID 19) and DRUG INEFFECTIVE (Lack of Efficacy) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported by reporter No treatment medications provided by the reporter.  This is a spontaneous case concerning a 52-year-old female patient with no medical history reported, who experienced the unexpected event of COVID-19 and drug ineffective. The event occurred approximately 8 months and 20 days after the second dose of the mRNA  1273 vaccine. At the time of report outcome of both events were still unknown. The reporter did not provide any causality assessments. The benefit-risk relationship of the vaccine is not affected by this report.   This case was linked to MOD-2022-464885 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 52-year-old female patient with no medical history reported, who experienced the unexpected event of COVID-19 and drug ineffective. The event occurred approximately 8 months and 20 days after the second dose of the mRNA  1273 vaccine. At the time of report outcome of both events were still unknown. The reporter did not provide any causality assessments. The benefit-risk relationship of the vaccine is not affected by this report.
10-12 hours after injection: Injection site inflamed, hot to touch and painful.  Swollen site approximately golf ball size.  14-16 hours after injection: tired feeling, lethargic, headache.    24 hours after: injection site still swollen, left arm is stiff and shooting pains into left forearm.   34-36 hours after injection: diarrhea, runny nose and headache.   36 hours after injection: symptoms subsiding and feeling less tired.  Injection site remains unchanged.
Information has been received from two Licensed Vocational Nurses (L.V.N.) referring to an unspecified number of patients of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. Since 27-JAN-2016 the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # L019836, expiration date: 24-MAR-2017; lot # L029306, expiration date 26-MAR-2017; lot # L019836, expiration date 24-MAR-2017, route and dose were not reported). The vaccine were exposed to 47.8 F for 1 hour and 5 minutes with previous temperature excursion of 27. 5 F for 1 hour 20 minutes. No adverse event had been reported. This is one of the several reports from the same reporter. Additional information has been requested.
Complained of having fever, chills and jaw pain 3-4 hours after receiving vaccine on 7-23-18. Temperature was not taken per mother at onset of fever or through the night. Mother reported fever of 100.9 F on 7-24-18 and managed with acetaminophen and ibuprofen. Mother's main concern was the complaint of jaw pain by client. Mother was instructed to see PCP for evaluation on 7-25-18 or ER visit for on 7-24-18. Nursing followed-up with Mother on 7-25-18 and reported that jaw pain and fever had resolved.
COVID vaccine reaction; This is a spontaneous report based on the information received by Pfizer (Reference ID: NUS2021US048356_NS) via a contactable consumer (patient). A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced covid vaccine reaction on an unspecified date. Outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Got shingritz series and have shingles now/suspected vaccination failure; Shingles in armpits, neck and chest; It's mostly itching; Deep pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (on an unknown date patient had the old shot and got shingles a few months afterwards).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pruritus and pain. On an unknown date, the outcome of the vaccination failure, pruritus and pain were unknown and the outcome of the shingles was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, pruritus and pain to be related to Shingrix and Shingrix.     Additional Information: GSK Receipt Date: 26-SEP-2022 Reporter's Comments: This case was reported by a patient via interactive digital media. The patient got the Shingrix series of two Shots. The patient believed he/she had shingles now in his/her armpits, chest and neck. It was mostly itching and deep pain when he/she had to wash. The patient was told that if he/she did get shingles it would not been as bad if he/she not had the vaccination. Additional supportive information: This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Day after vaccination, arm was swollen in  area the size of a mason jar, pain and itching associated
This spontaneous report as received from a registered nursery refers to unknown number of patients of unknown age. On an unknown date unknown number of patients were vaccinated with improperly stored (Oka/Merck) VARIVAX (lot number, dose, frequency, route, indication were not reported). No concomitant medications were reported. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
My left arm has persistent moderate pain at the injection site, persisting now almost three months after receiving first shot on March 17, 2021
Initially skin rash turn to skin burning and bubbling on whole right arm. very painful burn and stung sensation. skin has bubbles filled with liquid like burn symptom.  unable to sleep properly.
Patient received Pfizer vaccine L Deltoid at 0950.  At 1003 She complained of swollen, tingling, and red hands b/l.  No SOB, throat swelling, itching, scratching, no tongue swelling.  AAO x 3.  Talking with no difficulty.  No known allergies.    Benadryl 25 mg PO was administered.   She was monitored.  No further symptoms.
Child began throwing temper tantrums, erratic behavior, and showing aggressiveness within 1 week of MMR/V Vaccine. Infant became ill with viral symptoms within a week and lasted for 2 months following vaccine. Child continues to have unusual aggression and tantrums at age of 3 now.
Two days post vax pt presented with red, swollen, slightly firm area on left upper arm, 10 X 7.5 cm in size and warm to the touch. Parent stated it was worse one day post vax with some discomfort and itching.
J&J Dose 6/2/21 (lot not listed in database) COVID Positive 8/29/21  8/29/21: Pt is a 51 year old male who presented to ED with a chief complaint of vomiting. He has a past medical history of BPH, hypertension, type 2 diabetes mellitus, and GERD. Pt started feeling unwell on Tuesday of last week. He had fever, dizziness, body aches, headache and vomiting. He has had persistent vomiting since Tuesday. He has chronic bilateral lower extremities wounds, he is being seen by wound care. He was seen by urgent care with concerns for cellulitis and placed on cipro. He symptoms have worsened and he has developed severe shortness of breath, worse on exertion, and a dry cough. He has developed some nausea with diarrhea. He does wear a BIPAP at home. He is not on any diuretics. He believes he might have been told in the past he has congestive heart failure but is unsure. He has been full Covid-19 vaccinated.  On arrival to ED patient was febrile 101.3, tachycardic 113 hypotensive 99/66.  Laboratory findings were significant for hyponatremia 126. Hyperkalemia 5.4. Hyperglycemia 422. AKI BUN 27 and creatinine 2.84. Transaminitis 51. Anemia HGB 11.3. Chest x-ray showed CHF, superimposed pneumonia is not excluded. IV Levaquin was initiated in ED.  IV hydration NS 0.9% 1 L bolus given in ED.  9/22/21: Pt is a 51-year-old male with PMHx significant for HTN, T2DM, GERD, BPH and morbid obesity who was admitted on 8/29/2021 for acute hypoxic respiratory failure due to COVID PNA.  Patient was intubated on 08/30/2021.  He is s/p remdesivir, Actemra, dexamethasone, Rocephin, azithromycin, ceftazidime, vancomycin and Zosyn. He was diuresed with Lasix.  He remained on mechanical ventilation throughout hospitalization.  Patient was removed from precautions on 09/17/2021 and tracheostomy and PEG tube were placed at that time.  He was weaned from his paralytic on 09/18/2021.  He continues on Lovenox 40 mg subQ daily for VTE prophylaxis.  Patient with multifocal ventricular ectopy while hospitalized.  Cardiology was consulted.  Suspected etiology 2/2 COVID myocarditis. Patient unable to tolerate beta-blockers.  Magnesium levels and potassium levels were optimized.  Patient continues on tube feeds via PEG tube.  He has history of T2DM and was on GlucoStabilizer protocol but eventually transitioned to Lantus 35U BID with correctional dose insulin.  Patient with oral candidal lesions on 09/22/2021.  Started on nystatin oral solution 4 times daily for 7 days.  Patient was accepted by (privacy) and discharged to local HCF.
very weak; Fever; I feel Terrible; This case was reported by a consumer via call center representative and described the occurrence of fever in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose on unknown date).   On 24th September 2020, the patient received the 2nd dose of Shingrix. On 24th September 2020, less than a day after receiving Shingrix, the patient experienced fever and feeling unwell. On 25th September 2020, the patient experienced weakness. On an unknown date, the outcome of the fever, feeling unwell and weakness were unknown.   It was unknown if the reporter considered the fever, feeling unwell and weakness to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated 2nd dose of Shingrix. After vaccination patient felt terrible. The patient had fever on vaccination day and had felt very weak next day.
Shingles - pain developed approximately 3 days, rash began 24 hours  before seen in urgent care. Prescription for Valtrex. Symptoms resolved in approximately 2 weeks after beginning medication
Non-arteritic anterior Ischemic optic neuropathy. Partial vision loss OD, no treatment available. Vision loss remains stable and is not debilitating.  Disc at risk was present for several years w/o vision loss before incident.
pain radiating from arm to neck and coin size bruise on arm. no issues following the vaccine until about 1-2 days after. has no loss of arm mobility. has some soreness at site of injection into back and neck area. recommended to use ice and ibuprofen for treatment. referred to primary md or urgent care if they feel pain/adverse event was severe enough or they are very concerned. instructed patient to monitor for improvement with ice and ibuprofen, if no improvement in next few days contact primary md or visit urgent care and contact pharmacy. will follow up with patient.
Eyes rolling into back of head, lethargy, not reacting to sights or sounds, discomfort, fever, inconsolable crying, loss of appetite, diarrhea, slight vomiting.
approx 5min p/vax mom noticed a red splotchy rash on both legs & feet;one hives noted to lt lower leg, rash slow, traveled to back & head;rash faded & disappeared w/in 30min;
1 day /p recving vaxs pt developed high fever & vomiting, 2nd day later developed diarrhea, all sx subsided by 4 days
I started to have pain around my left elbow when using my hand or even just walking around May 7. When it did not get better after three weeks, I went to see my orthopedist, Dr. on May 28, 2021. He examined me and took x-rays (normal) and diagnosed it as radial tunnel syndrome/ulnar nerve lesion. I was instructed to perform an exercise at home, and to ice it and use topical diclofenac gel. After 4 weeks, it had improved a bit, but not fully, and I was then instructed to get hand therapy, which I am scheduled to begin on July 12, 2021. I do not know if this is related at all to the vaccine, but it occured in the same arm in which I received both doses and I reported it as a new medical problem when surveyed.
fever and chills 12 hours post vaccine.  Fever up to 104.1*F.  Fever and chills still occurring 3 days later.  Redness at site 24 hours post vaccine.  Redness growing in size.  Arm heavy and very sore.
6/22/19 Left arm felt warm/tingly, sx radiated L face and bottom lip. 6/28/19 Sx moved to the right side of mouth, tongue also felt tingly.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment information provided.   This case was linked to MOD-2021-395985 (Patient Link).
Headache and severe weakness started around 5 pm.   Difficult keeping head up.   Blood pressure low.    Reflux symptoms affecting heart.  Discomfort lower right back.
P.O.T.S shortly after shot started standing up and feeling dizzy dr noticed when I stood my heart would race and my BP would drop
Headache, Fever, Nausea Vomiting, chills, sore throat Narrative:
Patient states both her arms were swollen (the size of an orange on both arms), painful, hot to touch; both arms felt heavy.  Patient states she was seen by her chiropractor the following day, whom she states released the vaccine through chiropractic manipulation, as well taking prescribed pain medication (Dilaudid).  She states she felt better today, but her arms remain sore.