chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report received from a consumer via social media (via public comment to the J&J Corporate account) via a company representative concerned a male of an unspecified age, race and ethnicity. 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, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. The reporter stated that "Our son threw blood clots and suffered multiple bilateral kidney infarcts after his J and J vaccine. I pray that we don't see catastrophic events in the years to come from all of them." On an unspecified date, the patient experienced throwing blood clots, and suffered multiple bilateral kidney infarcts. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the threw blood clots and multiple bilateral kidney infarcts was not reported. This report was serious (Other Medically Important Condition). Sender's Comments: V0: 20220323641-Covid-19 vaccine ad26.cov2.s- Threw blood clots, multiple bilateral kidney infarcts. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Information has been received from a registered pharmacist (R. Ph.) concerning a 65 year old female who on 23-JUN-2008 was vaccinated with a dose of ZOSTAVAX (lot # 659409/0299X). Concomitant therapy included lisinopril, hydrochlorothiazide, TRICOR and ezetim (MSD). On an unspecified date the patient experienced an erythematous, raised, itchy area at the injection site. The patient contacted the physician. No product quality complaint was involved. Follow-up information was received from a registered pharmacist (R.Ph.) concerning a 65 year old female who on 23-JUN-2008 was vaccinated with the first dose of ZOSTAVAX in the left arm (lot # 659409/0299X) On 24-JUN-2008 at 1130, the patient developed rash on arm around injection site, itching, erythema. Subsequently, the patient recovered. Additional information is not expected.
Severe neck pain; Low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Severe neck pain) and PYREXIA (Low grade fever) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NECK PAIN (Severe neck pain) and PYREXIA (Low grade fever). At the time of the report, NECK PAIN (Severe neck pain) and PYREXIA (Low grade fever) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Patient under age 18 was vaccinated with Moderna, which is a vaccine error, but 17-year olds may be given Moderna for compassionate/off-label use. He was originally vaccinated with Pfizer (which he is eligible for) on April 7, so he returned too soon for the second dose. Troubleshooting: Scribe and vaccinator did not validate age or the information available on vaccine card;  screeners at the beginning of the process did not ask or turn her away on a Moderna-only day. Two records appear to have been created for this person. He also returned on a day that was not a Pfizer day and drove by "Moderna Only" signs to do so.
No additional AE reported; a 4 month old child was inadvertently administered a dose of PROQUAD; This spontaneous report has been received from a medical assistant referring to a 4-month-old patient of unknown gender. The patient's pertinent medical history, drug reactions, allergies and concomitant medications were not reported.   On 20-SEP-2021, the patient was vaccinated inadvertently with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant human albumin (rha) (PROQUAD) (product administered to patient of inappropriate age), at a dose of 0.5 milliliters (ml) (route of administration and anatomical site of vaccination were not reported; lot number T032144 has been verified to be valid, expiration date reported and established as 20-MAR-2022) as prophylaxis. A sterile diluent was used, at a dose of 0.5 milliliters (ml) (lot number U001957 has been verified to be valid, expiration date reported and established as 01-JUN-2023). No additional adverse event was reported.
Fever of 104, crying 6 hours straight, vomiting, lethargic, extreme warmth at injection site.
developed COVID-19 infection 4/26/21 chemo started 4/15/21
Morning after the 1st booster I couldn?t walk and was confused. According to my family this lasted for 2 days.
Red circle around injection site/Red sweelling started on day 6-7; Itching/woke up in the night, it was itching like crazy; Swollen/Red swelling started on day 6-7; Hot; Small bluish bruise; Arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE BRUISING (Small bluish bruise), PAIN IN EXTREMITY (Arm was sore), VACCINATION SITE WARMTH (Hot), VACCINATION SITE ERYTHEMA (Red circle around injection site/Red sweelling started on day 6-7) and PRURITUS (Itching/woke up in the night, it was itching like crazy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm was sore). On 11-Jan-2021, the patient experienced VACCINATION SITE BRUISING (Small bluish bruise). On 21-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot), PRURITUS (Itching/woke up in the night, it was itching like crazy) and VACCINATION SITE SWELLING (Swollen/Red swelling started on day 6-7). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red circle around injection site/Red sweelling started on day 6-7). The patient was treated with CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) for Cellulitis, at a dose of 500 milligram four times per day; LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) for Adverse event, at a dose of 1 dosage form and CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY) for Redness, at a dose of 1 dosage form once a day. On 24-Jan-2021, VACCINATION SITE BRUISING (Small bluish bruise) and PAIN IN EXTREMITY (Arm was sore) had resolved. On 25-Jan-2021, VACCINATION SITE WARMTH (Hot), VACCINATION SITE ERYTHEMA (Red circle around injection site/Red sweelling started on day 6-7), PRURITUS (Itching/woke up in the night, it was itching like crazy) and VACCINATION SITE SWELLING (Swollen/Red swelling started on day 6-7) had resolved.        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 medications were provided.  Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Email updated On 02-Jul-2021: Event information updated for vaccination site swelling and pain in extremity from not recovered to recovered; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Info has been received from a licensed practical nurse concerning a 58 year old male pt with a drug hypersensitivity to cephalexin (Keflex). There were no illnesses reported at the time of vaccination. On 11/13/2002 the pt was vaccinated with a 1st dose of pneumococcal vaccine 23 polyvalent subcutaneously in the right arm (Lot #642720/0172M). On 11/14/2002 the pt developed paresthesias in right hand, redness in right arm and soreness in right arm. It was reported that the pt recovered. Additional info is not expected.
Rash on backs of arms, front and back of torso, thighs, calves.
MINOR C/O INITIAL ARM PAIN STARTING IN THE PM, THEN WOKE UP IN AM 6/03/2011 WITH C/O ENTIRE DAY OF WHOLE BODY WEAKNESS, WORSE UPPER EXTREMITY, RESOLVED 6/04/2011 STATES WAS BETTER ONCE ARM PAIN RESOLVED
Patient called approx 2 1/2 - 3 1/2 hours after vaccination reporting: Headache, Temp over 101 degree F, Body aches, wheezing/coughing, "Flu like symptoms". Symptoms improved after pt. took APAP and Diphenhydramine. Symptoms lasted 3-4pm until 10-11 PM. No symptoms next day - completely resolved.
Off label use:  Kinrix is supposed to be given  at the earliest age of 4 years (here given to an 8 month old).   Immunizations due:  DTap,  Hib, Polio.   In order to minimize shots to be given, and not give immunization with Hep B( not needed), I administered Kinrix (DTap + polio), not noticing until after administration that it was not age appropriate.   these does should be OK as long as they are within the proper catch up schedule frequency, which both DTap and Polio were.   This was not the correct vaccination, however, and is reportable as an error.
Vaccine error no harm - patient presented to outreach event and received dose of Pfizer vaccine.   Following event during entry into CVMS it was noted patient had received J&J vaccine on March 7th
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 24Aug2021 14:30 (Lot number: EW0172) at the age of 59 years as dose 1, single for Covid-19 immunisation. Relevant medical history included: "Psoriatic arthropathy" (unspecified if ongoing), notes: Other Medical History: psoriatic arthritis; "Penicillin Allergy" (unspecified if ongoing), notes: Known allergies: Penicillin possibly. Concomitant medication(s) included: HUMIRA, administration date 15Aug2021. The following information was reported: VOMITING (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "Worst case of throwing up I have ever had. Temp of 101. chills, diarrhea, chest pains, cold sweats, headache, every joint in my body hurt 24 hours after the shot lasting about 12 hours, I still can no"; PYREXIA (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "Temp of 101"; CHILLS (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "chills"; DIARRHOEA (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "diarrhea"; CHEST PAIN (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "chest pains"; COLD SWEAT (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "cold sweats"; HEADACHE (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "headache"; ARTHRALGIA (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "every joint in my body hurt"; DYSPNOEA (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "can not take a deep breath"; CHEST DISCOMFORT (non-serious) with onset 25Aug2021 17:00, outcome "recovering", described as "chest hurting". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vomiting, pyrexia, chills, diarrhoea, chest pain, cold sweat, headache, arthralgia, dyspnoea, chest discomfort. Additional information: The patient received any other vaccines within 4 weeks prior to the COVID vaccine. Vaccine Facility type was Pharmacy or Drug Store. Other medications in two weeks was reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient has not been tested for COVID-19. Known allergies to Penicillin possibly. Other medical history reported as psoriatic arthritis. Adverse event did not require a visit to Emergency Room/Physician Office. The patient did not receive any treatment for the event. No follow-up attempts are possible. No further information is expected.
I received my second dose of Shingrix on 11/3/19 at pharmacy. Overnight I started getting body aches and the chills. Went to work but ended up going home due to body ache, extreme chills, headache, low-grade fever and felt nausea. I took dayquil and went to bed and woke up 4 hours later and I had broke the fever and felt fine. Only thing that hurt was the arm where the shot was given, but otherwise I am fine now. 1st does only thing that happened was my arm hurt for 5 days.
2 nd dose not received; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2 nd dose not received) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported ).    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2 nd dose not received). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2 nd dose not received) had resolved.        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.   It was reported that the patient received monoclonal antibody treatment for liver on 12-APR-2021 and reporter would like to know that the patient should wait 90 days due to the monoclonal treatment administration.  No concomitant medication reported   No treatment medication reported
Patient had first Moderna vaccination 1/11/21 ( sore arm and slept 24 hours)  and second Moderna 2/8/21 (felt rundown). She says she   was diagnosed with atrial fibrillation 9/23/21 and has been subsequently  hospitalized six times .
Patient loss color in face, throat, felt swollen, past out for a couple of seconds, administered Epipen. All occurred over 5 minutes. EMS responded.
Pain injection site/lot of aches and pains: First dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administered in deltoid right, administration date 08Apr2021 (Lot number: EW0151) at the age of 67 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Verbatim: Asthma, Diagnosed when she was a kid.; "Follicular lymphoma", start date: Nov2010 (unspecified if ongoing), notes: Verbatim: follicular lymphoma, History: The caller has follicular lymphoma, its intermittent, and she has to get Rituxan infusions for it. Rituxan infusions- unknown lot, NDC, and expiration date for all doses received. After the first dose that the caller received she got really cold and chilled and her teeth were chattering. From there on she has had to get a steroid and a Benadryl infusion prior. Then the caller has to stay there for 6 hours getting the slow drip of the Rituxan.; "Blood pressure" (unspecified if ongoing); "Anxiety" (unspecified if ongoing); "reactions to latex, aspirin, and all the penicillins." (unspecified if ongoing); "reactions to latex, aspirin, and all the penicillins." (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE taken for blood pressure abnormal; ALPRAZOLAM taken for anxiety. Past drug history included: Aspirin, notes: The caller has had reactions to latex, aspirin, and all the penicillins. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 09Apr2021, outcome "recovered" (Apr2021), described as "Pain injection site/lot of aches and pains: First dose". Therapeutic measures were taken as a result of vaccination site pain.   No follow-up attempts are possible. No further information is expected.
On May 19, 2021 I was fine till lunch, after lunch I got a stabbing pain in my left side.  It came and went for the entire day. I put heat on it when it didn't go away after taking Ibuprophin, The pain come and went over several days, I went to my Dr on Monday May 24th, she stated it may be a reaction to the vaccine or shingles. She gave me an antibiotic I took for 7 days. It got worse as time went on and I have since had further tests. It is still happening off and on.
Fluzone High-Dose to 59 year old patient / noAE; Fluzone High-Dose to 59 year old patient / noAE; Initial information received on 05-Mar-2020 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked with case 2020SA065020 and 2020SA065018 (same reporter)  This case involves 59 year old patient (gender not reported) who was vaccinated with INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (Inappropriate age at vaccine administration, PT: Product administered to patient of inappropriate age)  Medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patients received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  This is a case of actual medication error due to product administered to patient of inappropriate age and overdose.  At the time of this report, no adverse event was reported.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Procedures - documented in this encounter Procedure Name Priority Date/Time Associated Diagnosis Comments SARS COV-2 RNA ROUTINE 04/23/2021 9:14 AM EDT Sick      4/26/2021COVID-19 virus infection +1 more Dx Progress Notes Encounter Date: 4/26/2021 ? ? Signed Expand AllCollapse All       History of Present Illness: Patient ID: Patient is a 78 y.o. male who presents today, via phone,  with the following complaints: Tested April 24 positive Covid 19.  He got the first vaccine 3 weeks ago and was supposed to get the second one tomorrow.  o When did symptoms start?   4/20/2021     o Fever:  ?Yes    ?No     o Cough:  ?Yes    ?No  "terrible"  Productive--phlegm o Shortness of Breath:  ?Yes    ?No     o Chest Tightness:?Yes    ?No     o Body Aches:  ?Yes    ?No       o Headaches:  ?Yes    ?No     o Sore Throat:  ?Yes    ?No      o Nasal Drainage:  ?Yes    ?No    A lot: Thin and wet o Sinus Pressure:  ?Yes    ?No     o GI Symptoms:   ?Yes    ?No     o Ear Pain/Fullness: ?Yes    ?No     o Loss of Taste or Smell:  ?Yes    ?No    Both o Medications Taken:  Mucinex, Tylenol, Zyrtec o Sick contacts:?Yes    ?No       Cough is the most bothersome symptom.
Information has been received from a RN concerning a 7 year old Caucasian female with attention deficit disorder and no drug allergies who on 24Nov98 was vaccinated with a dose of varicella virus vaccine live (lot 626966/1054H). Concomitant vaccination given on the same day included the fourth dose of diphtheria toxoid (+) pertussis acellular Biken vaccine (+) tetanus toxoid (Tripedia) (lot0939790) given IM in the left vastus lateralis (LVL) and the fourth dose of Hib conj vaccine (CRM197) (Hibtiter) (lot M240RL) given IM in the LVL. There was no illness at the time of vaccination. Concomitant therapy included sertraline HC1 (Zoloft), clonidine and amphetamine aspartate/amephetamine SO4/dex (Adderall tablets). On 13Jun05 (previously reported as 11Jun05) the pt developed breakthrough chickenpox characterized by a lot of pox on her chest, back and perineal area. Unspecified medical attention was sought. No lab or diagnostic tests were performed. The pt was reported to be in active recovery as of 17Jun05. The reporter also noted that the pt had received the following vaccinations on 14Jul98: the first dose of measles virus vaccine live  (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (lot625314/1681E) given SC in the LVL and the third dose of poliovirus vaccine inactivated (IPOL) (lot U0903) given IM in the RL. No product quality complaint was involved. The nurse also reported that the pt's brother developed breakthrough chickenpox (associated WAES0506USA02915). Additional information is not expected.
Day 5 post injection: dizziness, headache, nauseous Day 6 post injection: numbness to my tongue, left eye burning Day 7 post injection: unable to blink my left eye, total paralysis of left side of my face
Information received regarding pt who received vax on 12/04/1998. On approximately 01/14/1999, the pt experienced generalized myopathy. The reporting physician noted that the pt has muscle weakness in the legs and arms, however, she does not have involuntary movements of the arms. Additional information has been requested.
Purple bruises to right thigh x2, 24 hours after first shot and 72 hours after first shot.
MOTHER OF 12 MONTH OLD BOY RECEIVED FIRST DOSE OF COVID 19 VACCINE AT 9:15 AM  SHE BREASTFED HER 12 MONTH OLD SON 3 HOURS LATER AND WHILE BREASTFEEDING THE CHILD DEVELOPED ACUTE ANAPHYLAXIS.    TO BE CLEAR:  MOTHER  HAD THE VACCINE AND THE CHILD HAD THE REACTION