chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a 73 year old male who on 12-OCT-2007 was vaccinated subcutaneously with 065 mL of zoster vaccine live (Oka/Merck). Concomitant therapy included digoxin and "an Ace inhibitor." It was reported that "within twenty-four hours of the vaccination," approximately 13-OCT-2007, the patient developed a rash from his lower back to his left knee. The patient reported that his doctor diagnosed the rash as shingles. At the time of reporting the rash was gone, but his leg was still "touch sensitive." Unspecified medical attention was sought. There was no product quality complaint. There were no lab diagnostic studies performed. Additional information has been requested.
SEVERE REACTIONS; This spontaneous report received from a patient via a company representative concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced severe reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe reactions was not reported. This report was non-serious.
Itchy, circular rash  about 2 inches in diameter- looks like COVID ARM when I look it up. May have been there prior to 8 days post dose, but I didn't feel anything.
Fatigue; Body aches; Fever; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 25-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 18Aug2021 (at the age of 25-years-old) as a single dose for COVID-19 immunisation. Medical history included COVID-19, which was diagnosed prior to vaccination. Concomitant medications were not reported. On an unknown date in Aug2021, the patient experienced fatigue, body aches and fever. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events fatigue, body aches and fever was unknown at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
tinnitus. no available treatment. 6 day steroid pack attempted. ongoing over 14 weeks now.
A-fib; renal dysfunction; This is a spontaneous report from a contactable physician. A 77-year-old male patient received BNT162B2 (Lot number was not reported), via an unspecified route of administration in Mar2021 (at the age of 77-year-old) as single dose for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. Concomitant medications included carbidopa and levodopa. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. In Mar2021, the patient experienced onset of A-fib and resultant renal dysfunction shortly after injection. The adverse events resulted in doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. The patient was treated with Cardioversion and medical management for the event A-fib. The outcome of the events was recovered on unspecified date.    Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events of Atrial Fibrillation and Renal Impairment and the suspect vaccine BNT162B2 cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug 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.
In about 24 hours of taking the flu shot, my pinky finger on the right hand (opposite arm of flu shot) started to feel pain and became swollen along the right side of my hand.  I thought this was a temporary side effect but it reoccurs every couple of weeks.
receiving accidentally a second dose; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number H9FM5, expiry date 7th May 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DIPHTHERIA VACCINE TOXOID + PERTUSSIS TOXOID + POLIOMYELITIS VACCINE + TETANUS VACCINE TOXOID (KINRIX).   On 18th February 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 18th February 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The registered nurse (RN) reported that, the patient accidentally received a second dose of Kinrix, which led to extra dose administered. The reporter consented to follow up.
Severe headache 10/04/16 (6:00 P.M. - 10/05/16 - noon). Body aches 10/04/16 (6:00 P.M. - 10/06/16 - 2:00 P.M.). Upper left arm rash, itchy 10/05/16 (9:00 AM - 10/08/16 noon). Fatigue 10/04/16 (6:00 P.M. - 10/10/16 - 8:00 am).
6/1/06 approx 24 hrs after vaccine administered child c/o headache and not feeling well. 9:30PM child had 101 fever and felt knot under L arm. Knot very tender to touch. Ibuprofen given. Site of injection has 3x5" reddened, swollen area. 6/2/06 child woke up with swollen left side of chest under L arm. Mom continues to give Ibuprofen. Fever now 99. Mom to call Dr for evaluation.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history was unknown. The reporter stated that on 16-OCT-2014, expired ZOSTAVAX (lot # J007855, expiry date: 28-SEP-2014, dose, route of administration and anatomical location was unknown) was inadvertently administered to the patient. Concomitant medications were unspecified by reporter. No adverse effects reported. The outcome of the events was unknown. No additional information was available. Additional information has been requested.
Flare up; Dry patches/ dry skin on lower legs; More fatigue; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (Flare up), DRY SKIN (Dry patches/ dry skin on lower legs), FATIGUE (More fatigue) and ARTHRALGIA (Joint pain) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Plaque psoriasis and Psoriatic arthritis.    No Medical History information was reported.   On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced CONDITION AGGRAVATED (Flare up), DRY SKIN (Dry patches/ dry skin on lower legs), FATIGUE (More fatigue) and ARTHRALGIA (Joint pain). At the time of the report, CONDITION AGGRAVATED (Flare up) and DRY SKIN (Dry patches/ dry skin on lower legs) had not resolved and FATIGUE (More fatigue) and ARTHRALGIA (Joint pain) outcome was unknown.            Concomitant product use was not provided by the reporter.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality with Humira for the event of flare up was a reasonable possibility and for the events of dry patches/ dry skin on lower legs, more fatigue and joint pain was not provided.  No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
2 hours, post vax, had increased temperature, chills and body aches; temperature increased to 100.4F that lasted 2 hours and chills continued through evening. Had some body aches today, 10/26/00, and chills with decreased temperature.
rash at the injection site; headache; feeling tired; This spontaneous report was received from nurse practitioner and refers to a 55-year-old female patient. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided.  On 15-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) 1 dose, lot #W005206, expiration date: 14-FEB-2024 (strength and route of administration were not provided) for immunisation.  On 29-SEP-2022, the patient experienced headache and feeling tired (Headache, Fatigue). The outcome of these events was unknown. On 30-SEP-2022, also reported as 15 days post vaccination, the patient experienced rash at the injection site (Vaccination site rash). The outcome of this event was reported as not recovered. Action taken was not applicable.  The causal relationship between feeling tired and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown. The causal relationship between headache and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown. The causal relationship between rash at the injection site and varicella virus vaccine live (oka/merck) (VARIVAX) was unknown.
Patient's left eye crossed inward and he could not move his eye to look to the left, only straight ahead or crossed.  Was diagnosed with 6th nerve palsy.
Patient reports new nerve type pain in shoulder. He cannot sleep on that side (left ) and has difficulty exerting pressure toward his inner body using that arm.  Patient has not sought medical attention; he plans to see his chiropractor and possibly his primary medical doctor.
I got the 1st dose of the Moderna Covid-19 vaccine. I was tired.; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I got the 1st dose of the Moderna Covid-19 vaccine. I was tired.) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced FATIGUE (I got the 1st dose of the Moderna Covid-19 vaccine. I was tired.). At the time of the report, FATIGUE (I got the 1st dose of the Moderna Covid-19 vaccine. I was tired.) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications details was not reported by the reporter.   This case was linked to MOD-2021-370421 (Patient Link).
h/a, fatigue, local erythema & induration, muscle spasm @ inj site, dermagraphia;
significant swelling and pain in under arm - started on Day 2 and still present on Day 5
Prolonged cough. Tested positive for COVID after vaccination. Received the antibody infusion.
shingles; other zoster related injuries; Information has been received from a lawyer and a currently 69-year-old patient of unknown gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 01-MAY-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently (date not reported), the patient was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX) use: shingles and other zoster related injuries. The outcome of all events was unknown. The causality between all events and zoster vaccine live (ZOSTAVAX) was related
Initial report received on 12 November 2009 from a health care professional. This case (involving a 49-year-old female) is part of a cluster of three cases received from the same reporter with the same product and lot-number. Information regarding the other two patients is reported in cases 2009-04810 and 2009-04931. A 49-year-old female patient, who had no concurrent illness, but has allergy to sulfa and Penicillin, and a history of "MVP" (mitral valve prolapse) and left hip pain (etiology not reported), had received an intramuscular left deltoid injection of Influenza A (H1N1) 2009 Monovalent vaccine-Preservative (lot number UP009AA) on 10 November 2009. A few hours post-vaccination, the patient developed intermittent numbness and tingling in the left shoulder, arm, hand, and fingers especially the thumb. The patient also experienced aggravation of her left hip pain brought on by the vaccine, and a chest cold without productive cough (date not reported). The patient required a doctor visit; however, no relevant diagnostic tests or laboratory data were performed. It was not reported whether the patient required any treatment. The patient is currently being seen by an occupational health doctor. At the time of this report, the patient had not recovered. Documents held by sender: None.   12/3/2009 PCP notes from 11/12 and 12/3/2009, patient with c/o's lt shoulder, hand, arm and hip numbness/tingling. Rx'd prednisone. Sx resolved as of 12/3/2009.
No adverse event, patient didn't report any abnormal side effects but was given vaccine even though only indicated 60 years or older. Patient was 54 at time shot was given
Headache; body aches; fatigue; swelling and redness at injection site; swelling and redness at injection site; swollen lymph nodes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Sep2022 at 15:00 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTUERER UNKNOWN), for COVID-19 immunization. The following information was reported: HEADACHE (non-serious) with onset 17Sep2022 at 03:00, outcome "recovering"; PAIN (non-serious) with onset 17Sep2022 at 03:00, outcome "recovering", described as "body aches"; FATIGUE (non-serious) with onset 17Sep2022 at 03:00, outcome "recovering"; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 17Sep2022 at 03:00, outcome "recovering" and all described as "swelling and redness at injection site"; LYMPHADENOPATHY (non-serious) with onset 17Sep2022 at 03:00, outcome "recovering", described as "swollen lymph nodes". Therapeutic measures were not taken as a result of headache, pain, fatigue, vaccination site swelling, vaccination site erythema, lymphadenopathy.  Additional information: Patient did not take other vaccine in four weeks and not had other medications in two weeks. Patient did not had covid prior vaccination and not tested covid post vaccination. Known allergies: No. Other medical history: No.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Syncopal episode with eye-rolling (no tonic-clonic activity, no loss of bladder control) lasting about 10 seconds. Occurred about 10 minutes after administration of Menomune and PPD. Pt had not eaten for >12 hours. Vital signs stable. Afebrile. No rash. Injection site OK.
Vomited; This is a spontaneous report from contactable physician via Pfizer Sales Representative. A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on 17Jul2020 at SINGLE DOSE for immunization, or received meningococcal vaccine b rfhbp/nada/nhba omv (BEXSERO), via an unspecified route of administration on 17Jul2020 at unknown dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received meningococcal group b rlp2086 (TRUMENBA) in Aug2019 for immunisation. The doctor mentioned that they had given a Meningitis B vaccine to a patient and the patient vomited. The doctor did not remember if it was Trumenba or Bexsero. The vaccine was given on 17Jul2020, and several hours later they vomited.  The doctor said that in Aug2019, the patient received her first dose of Trumenba. The doctor said she cannot guarantee she got Trumenba as the second dose. They could have grabbed Bexsero. Sometimes they don't always give Trumenba. It should be the same one, but that it not always the case. The doctor said she would check with the nurse to see which one patient received and still has not followed back up with the representative. The patient experienced vomited on 17Jul2020 with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
the newly FDA (Food and Drug Administration) authorized Moderna bivalent formulation has a slightly higher dosage than what their child recently received.  According to the guidelines from the CDC (Centers for Disease Control and Prevention), it is recommended that we repeat their child?s most recent dose of COVID-19 vaccine to ensure proper protection. No adverse reaction noted
Pain and soreness; swelling; erythema; chills; fever (self reported. No documentation)
Light headed, weakness, and mild feeling as if breathing was becoming affected.  No shortness of breath, but a little tightness in throat area.
Case number PHEH2012US016112 is an initial spontaneous report received from a pharmacist on 09 Aug 2012. This case refers to 26-year-old male patient. He was given only MenCYW-135 liquid conjugate component of MENVEO (batch number: X11041) intramuscularly on 20 Jul 2012. He did not receive the MenA lyophilized conjugate component of MENVEO. No adverse event was reported following administration error. No other information was available.
dizzy; weak; body aches; nausea; temperature was 99.2; right arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), ASTHENIA (weak), MYALGIA (body aches), NAUSEA (nausea) and PYREXIA (temperature was 99.2) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 030M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was provided.  Concomitant products included HERBAL NOS, INOSITOL, LYCOPENE, MINERALS NOS, RESVERATROL, VITAMINS NOS, XANTOFYL, ZEAXANTHIN (PHYTOMULTI), COLECALCIFEROL (D3), LUTEIN [XANTOFYL], ALOE VERA and CALCIUM, MAGNESIUM (CALCIUM MAGNESIUM [CALCIUM;MAGNESIUM]) for an unknown indication.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (right arm was sore). On 11-Mar-2021, the patient experienced DIZZINESS (dizzy), ASTHENIA (weak), MYALGIA (body aches), NAUSEA (nausea) and PYREXIA (temperature was 99.2). On 12-Mar-2021, DIZZINESS (dizzy), ASTHENIA (weak), MYALGIA (body aches), NAUSEA (nausea), PYREXIA (temperature was 99.2) and VACCINATION SITE PAIN (right arm was sore) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Mar-2021, Body temperature: 99.2 (High) at 2:30 a.m. temperature was 99.2 and 100.8 (High) at 7:50 a.m. temperature was 100.8.         The action taken with mRNA-1273 (Moderna COVID-19 vaccine) was not applicable  No treatment medications were reported   This case was linked to MOD-2021-107720, MOD-2021-107720 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: No new information was provided
3 weeks following vaccination with Anthrax, Smallpox, Typhoid (18 May). Pt. with pruritic papular lesions which started on distal extremities (wrists/ankles) and progressed to trunk.
Within 24 hours, the pt developed an excessive irritability and inconsolable crying. The physician prescribed acetaminophen. She was seen by the physician on 7/10/00.
Oral allergy response began approx. 15 minutes post-vaccine. Swelling of tongue, face, and eyes notable. Difficult swallowing in line with patient's prior oral allergy responses. Elevated HR and BP while seated. Reaction worsened for approx. 15 minutes before stabilizing with swelling remaining. Doctors wanted to treat with epinephrine and IV benadryl; patient discharged due to financial and transportation concerns. Patient self-treated with IM epi, disolving cetirizine, PO famotidine, and liquid diphenhydramine via J tube (per orders for previous non-anaphylactic oral allergy reactions). Tongue swelling reduced to near normal by the 4 hour mark, facial and eye swelling remained for approx. 24 hours before reducing to normal.
SARS-CoV-2 RdRp Resp Ql NAA+probe~COVID-19 rapid diagnostic test (nucleic acid amplification test NAAT) performed on 7/10/21 at a pharmacy and came back positive. Pharmacy most likely is not in location, but in location. Case investigation interview with patient has not been performed at the time of writing this note.
arm soreness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The reporter was wife of the patient. The patient received dose of Shingrix in the left arm, 6 weeke ago from the date of reporting. The patient after vaccination still experiencing a sore arm. The reporter did not consent to follow up. This is 1 of the 3 cases reported by the same reporter. There was discrepancy between the outcome reported in the structured field (not recovered) and the outcome reported in the source document (recovering).
3 days after the vaccine, he developed fevers of 103 and malaise. On day 5 he began to complain about pain in his left flank. He was taken to ER at the Hospital on day 6, extensive work up for possible kidney stone or pyelonephritis. No stones large enough to cause a blockage were seen.  Discharged home in care of mother who is a retired physician assistant. At home, while assisting in bath, his left testicle was observed to be red and enlarged. Returned to ER; ultrasound revealed epididymo-orchitis. Cultures negative.  Discharged on antibiotic, followed by Urology, cleared after one month. Of note, his CBC with diff showed high WBCs but normal eosinophil count, which his hematologist took as a good sign!