chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, and concomitant medication. On or about 12-Feb-2016 the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 05-Oct-2016, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses and pain and suffering and other damages. Additional information has been requested.
Systemic: Allergic: Itch Generalized-Mild, Systemic: Allergic: Rash Generalized-Mild
Information has been received from a pharmacist concerning a female who was vaccinated with 0.65 ml dose of ZOSTAVAX (Merck) while she had an active case of shingles and got a rash at the injection site that looked like shingles. It was unknown if the patient sought medical attention. At the time of report, the patient's status was unknown. Additional information has been requested.
Lot # 053E21A was administered outside the 30-day Use by Date.  A case was opened with Moderna ID.  "The vaccine administered maintained the activity necessary to protect against the SARS-CoV-2 (Covid-19) virus at time of administration."
covid arm; warm; itchy; red circle about 4-5 inches in diameter; not very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (covid arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red circle about 4-5 inches in diameter) and MYALGIA (not very sore) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, ENALAPRIL, GABAPENTIN, HYDROCHLOROTHIAZIDE, PROPRANOLOL and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 15-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-May-2021, the patient experienced VACCINATION COMPLICATION (covid arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red circle about 4-5 inches in diameter) and MYALGIA (not very sore). On 21-May-2021, VACCINATION COMPLICATION (covid arm), VACCINATION SITE WARMTH (warm), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE ERYTHEMA (red circle about 4-5 inches in diameter) and MYALGIA (not very sore) had resolved.            Treatment medications were not reported.   This case was linked to MOD-2022-451928, MOD-2022-451878, MOD-2022-451928 (Patient Link).
Intestinal cramping, somewhat loose stool, body aches and pains, fever ranging from 99.7 to 101, fatigue.
Submassive PE and DVT with other risk factors.  Started on Anticoagulation and appears to be improving.
he did not feel good from the day he received the shot, 6 days later he suddenly got a very very bad headache and couldn't breathe. he was taken by ambulance to Hospital where they diagnosed him with a stroke. He was airlifted to another Hospital and was there until 3-13-21 while there he received a feeding tube because he couldn't eat because he lost the ability to swallow without it going to his lungs. he was then sent to a rehab facility till 4-6-21. with a total hospitals and rehab stay of a month and 2 days. he is extremely weak on his right side unable to stand and walk on his own, he has vertigo and severe balance issues, he also still is unable to see having double vision and other issues escalating the dizziness. still on multiple medications for issues from this. he was a very strong independent hard working man, working more then half the people half his age, this has greatly effected his life and we are lucky to still have him because the stroke was bad enough that we know that they saved his life only by the quick action of the hospital
Patient came to second dose vaccine appointment. Patient screened by nurse and stated she had facial tingling and increased heart rate after first dose received for 45  min. Patient did not report symptoms to staff while under observation.  Patient advised to receive second dose vaccine at hospital due to reaction. Patient verbalized understanding.
pt recvd 1st dose of Hep B vax 20APR89 & later devel hives,laryngitis,& flushed appearance.
administering Bexsero instead of Menveo; DOB:26-MAR-2022, administering Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 3-day-old male patient who received Men B NVS (Bexsero) (batch number ABXB36AA, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   In March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 29-Mar-2022 Reporter's Comments: Agency reported potential case of administering Bexsero instead of Menveo. Health care professional (HCP) said that the count of Bexsero and Menveo were off they realized the possible mistake. The reporter consented to follow up. Additional Supportive Information: The patient born on 26th March 2022, received Bexsero instead of Menveo, which led to wrong vaccine administered and inappropriate age at vaccine administration. This is one of four cases, reported by the same reporter. Note: Conservatively considered the DOB provided by the reporter. Clarification was raised.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022056732:same reporter US-GLAXOSMITHKLINE-US2022056734:same reporter US-GLAXOSMITHKLINE-US2022056735:same reporter
1 day post vax pt exp stomach cramps x 2 days, lower back pain, discomfort RLQ & LLQ w/poss swelling, urinating freq color dk yelllow & odor strong; all sx including BM's more freq & liquid but nl color seem to have occurred post vax; t100;
This spontaneous report was received from a Registered Nurse concerning a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with the first dose of GARDASIL 9 (dose, route, lot number and expiration date were not reported), and approximately one month later, the patient received the second dose of GARDASIL 9 (dose, route, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Pain in underarm; flu like symptoms; This is a spontaneous report from a contactable physician via Pfizer sales representative. This physician reported for self that:  From: (Name) Reporter Name: (Name), MD Reported by: Physician Reporter Contact Information: (address withheld)  Patient Name: (Name) Description of Event: The patient experience pain in underarm for 3 days after 2nd dose of the vaccine as well as flu like symptoms for 24 hours. Name of Product: COVID 19 vaccine Awareness Date: 9Feb2021 Country of Occurrence: United States Event took place after use of product.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
About 74 days after vaccination is when I finally had my expected menstrual cycle. So it would have been 2 months late since expected. I only thought to report it when I had several friends who were experiencing the same problem. I went and saw my doctor in June and had several appointment after that like ultrasounds and other imaging to see what is going on with my body. I was was diagnosed with Polycystic Ovarian Syndrome. No treatment recommendations yet. Most treatment recommendations are to treat the comorbidity not the illness itself.
Daily headache lasting until 9/3/21. Bug lump with red outline starting on 8/29 until 9/3/21
12 mo old inadvertantly given Zostavax yesterday with other vaccines at 12 mo instead of Proquad. The vial had been placed in a Proquad box and the medical assistant did not realize it was the wrong bottle until the vaccine had been given. No unusual signs or symptoms yet.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 17Sep2022 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 54 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown) and as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Pcn" (unspecified if ongoing); "known allergies: sulfa" (unspecified if ongoing); "known allergies: cipro" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Oct2023, outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid (start date: 03Oct2023, stop date: 08Oct2023).  The information on the batch/lot number for [BNT162B2, BNT162B2 OMI BA.4-5] has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300334775 same patient, different drug/events;
Felt needle sticks on my left side of my cheek moving to my temples areas, front head and moving to my left cheek, loosing upper strength and lower extremity strength, worse on my left side, loosing balance and falling inside my tub on Tuesday.
Generalized erythema and swelling of posterior in area from injection site to elbow DTdt involved. Have patient use ice and Ibuprofen TID until sx cleared.
This case was reported by a consumer to a sales representative and described the occurrence of autism in a female patient who received diphtheria and tetanus toxoids and acellular pertussis vaccine. The consumer is the mother of the patient. A health care professional has not verified this report. On an unspecified date, the patient received a dose of diphtheria and tetanus toxoids and acellular pertussis vaccine. At an unspecified time following the administration of diphtheria and tetanus toxoids and acellular pertussis vaccine, on an unknown date before 3/23/05, the patient experienced autism. The outcome of the event was not reported. No contact details for the reporter or physician were provided. Autism was assessed as medically serious (OMIC).
Pt reports extreme "shaking", feeling "hot", muscle and joint pain, frequent urination, nasal congestion, and extreme fatigue after receiving Td vaccine.  Symptoms started about 12 hours after receiving vaccine.  All symptoms resolved except fatigue by 72 hours.
21AUG97 rash w/o other sx;10SEP97 URI, feb-Ceftin began;12SEP97 febrile seizure w/t106 reported;13SEP97 second febrile sz, loose stools;15SEP97 fever subsiding;
pt recv vax & it was reported that win2-min pt exp total body urticaria, facial swelling & resp distress;
Patient received the Moderna vaccine on 3.18.21. Patient did not report any issue until 3.27.21. Patient states that on 3.26.21, an area of "irritation" developed at the sight of injection, a small circular area that is pink/red,  Patient denied any swelling, purulence, signs/symptoms of infection, warmth, or pain. Patient said it was only a little red and irritable. Patient took an antihistamine (Xyzal) this morning and mentioned the area has slightly improved. I informed patient I would follow up with him daily until resolution. Patient denied requiring immediate medical attention; however, I instructed patient to seek medical attention upon development of systemic signs of infection such as fever, chills, or spreading of redness around injection site.
lot: 026A21A NDC 80777-273-99.he started with symptoms after vaccine which progressed.  SOBOE, N/V, fever & fatigue x 1 week in setting of recent COVID vaccine. admitted to hospital via ED with pleural effusion, AKI, Labs notable for +ANA, +smith/RNP, SSA/SSB,+Scl-70, dsDNA, low complements, lymphopenia, leucopenia, thrombocytopenia, rhabdo,worseing renal failure (now on dialysis) with PU, kidney biopsy largely unrevealing. Bone marrow biopsy concerning or HLH. DDx HLH 2/2 to new onset SLE with overlap syndrome/MCTD.patient needed to be transferred to a tertiary center, now at another facility in critical condition with encephalopathy.
Angina. Pharmacy was suppose to give me PREVNAR 13 (by doctors order) and they made a mistake and gave me PNEUMOVAX 23. I was fine when I went to bed. I woke up at 1:15 A.M. with chest pain, pain in my arm, jaw and back on 11-2 - I lay still until the pain went away, I had another episode on 12-7 and I was admitted to the hospital.
Redness, swelling, pain within 12 hours of receiving his 3rd anthrax shot. Symptoms: Edema at injection site 50-120mm, Erythema, Swelling, Pain.
5 minutes post 2nd vaccination, patient sitting in chair felt funny, thought it was anxiety, remembers waking up on the ground. patient was transferred from ground to stretcher and brought to pod b first aid. MD assessed patient in triage, pt had history of syncope in high school. 1 cm laceration identified to patient left eye, below eyebrow and small abrasion below left nare. MD determined patient needed sutures for laceration in ED.
Janssen COVID-19 Vaccine EUA.   Please note the chronic knee injury previously reported. A day after my shot, I experienced 48 hours of joint pain in my chronically injured knee. I ruled out outlying factors like excessive exercise, overuse, or weather events, and could only conclude the shot was affecting me.   Today, around 5 pm until writing this report at 12:30 am, my knee has been experiencing joint pain again, and again, I've ruled out all other reasons other than this potentially being  an adverse symptom of the shot.   The joint pain is mostly felt in the front of my knee, underneath my patella, and does not move to other areas. The knee is warm to the touch and not swollen like it usually would be when I experience overuse.
got chills; This case was reported by a consumer via interactive digital media and described the occurrence of chills in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine with an associated reaction of feeling abnormal (1st dose received on an unknown date and had kicked rear end, refer case US2021AMR197865).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chills. On an unknown date, the outcome of the chills was unknown.   It was unknown if the reporter considered the chills to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not reported. The patient had the Shingles shot and just got chills.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR197865:same reporter, same patient, different dose, 1st dose
Nurse administer Hib B vaccine to a 13 year old. Patient was to old to receive vaccine. No adverse event reported.
Had a severe SVT episode of 170 bpm that lasted for 15 hours beginning at 10:00 am on Tuesday, February 9, 2021, and continuing until 1:30 am on the 10th of Feb. 2021. Subsequent muscle aches and general soreness without fever the following day (Feb. 10, 2021). Historical episodes of SVT typically last between 1-3 hours, and I had not had a recent SVT episode prior to vaccination. During the 15 hour SVT episode post vaccination, I experienced much higher than normal blood pressure readings and erratic blood glucose levels which cannot be explained by diet changes, even though I was still taking my prescribed medications on schedule.
Fast heartbeats, PVCs,  difficulty breathing one night, severe rash, nausea, elevated blood pressure
This spontaneous report was received from a consumer refers to a 67-year-old female patient. The patient's medical history and concomitant medications were not reported. The patient's current condition included known allergy to penicillin. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 (lot # R016640 and expiration date 28-JAN-2020) (dose, units and frequency unknown). On an unknown date the patient experienced redness, localized pain and swelling, hot to the touch and tenderness at site of Injection and low fever. The doctor gave the patient MEDROL. The outcome of the events was unknown. Causality of the events was not reported.
Swelling, noted, redness, edema, warmth to touch, joints aching, Teeth aching.
Patient is 12 years old but was given pfizer 5yo-11yo bilvalent 0.2 mL booster dose. Patient experience no side effects or symptoms.
lymph nodes swelled; dizziness/lightheaded; heavy metal taste in mouth; nausea; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 53 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm left, administration date 24Nov2021 08:30 (Lot number: fg3527) at the age of 53 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "migraines" (unspecified if ongoing); "Allergy" (unspecified if ongoing), notes: other immunizations, and have been exempt from them until this mandate. The patient's concomitant medications were not reported. No other vaccine in four weeks, no other medications in two weeks.  The following information was reported: LYMPHADENOPATHY (medically significant) with onset 24Nov2021 08:30, outcome "recovered with sequelae", described as "lymph nodes swelled"; DIZZINESS (medically significant) with onset 24Nov2021 08:30, outcome "recovered with sequelae", described as "dizziness/lightheaded"; DYSGEUSIA (medically significant) with onset 24Nov2021 08:30, outcome "recovered with sequelae", described as "heavy metal taste in mouth"; NAUSEA (medically significant) with onset 24Nov2021 08:30, outcome "recovered with sequelae", described as "nausea". Clinical course: First dose her lymph nodes swelled immediately, dizziness, lightheaded, heavy metal taste in mouth, nausea. The events "lymph nodes swelled", "dizziness/lightheaded", "heavy metal taste in mouth" and "nausea" were evaluated at the emergency room visit. Therapeutic measures were taken as a result of lymphadenopathy, dizziness, dysgeusia, nausea,  treatment included benadryl, prednisone, pepcid. No covid prior vaccination. No covid tested post vaccination.; Sender's Comments: Based on the available information provided, the causal association between the reported events and the suspect drug, cannot be excluded. Case to be reassessed should a follow-up information becomes available. 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.,Linked Report(s) : US-PFIZER INC-202200148543 same patient/drug, different vaccine dose/event
Symptoms began shortly after receiving the Covid and Flu vaccine , earlier in the day, per family report.  EMS upon arrival found O2 sat on RA 83% with upper airway wheezing bilaterally.  Patient denied any chest pain, rashes or itching.  Per family patient began complaining of of severe chills, increasing weakness, developing nausea, wheezing, increased work of breathing.
Patient presented to ED on 5/8/21 with worsening SOB. Patient is fully vaccinated. It was most likely CHF exacerbation superimposed on COVID recovering individual and the patient was treated appropriately, got discharged on 5/14/21.
Red site from the top of my left shoulder down about 12 inches and about 3 inches wide.  No treatment done, was not bothersome.
Case number PHEH2015US021031, is an initial spontaneous report from a consumer received on 16 Oct 2015. This report refers to a 56 years old male patient. Medical history and concomitant medication were not reported. The patient was vaccinated with FLUVIRIN (batch number: 1514801) intramuscularly on 14 Oct 2015. On the same day after vaccination the patient developed swollen lymph node on the left side, which was the same side as injection. Outcome of the event was reported as condition unchanged. The seriousness and causality of the event was not reported.
VACCINE ADMINISTRATION ERROR. ALREADY RECIEVED FLU VACCINE ON 10/18/22.
Got vaccine years ago and one day later had shingles; This case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 1 day after receiving Shingles vaccine, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.  Additional details provided were as follows: The case was reported by patient himself/herself. Age at vaccination was not reported. The patient received the Shingles vaccine years ago and one day later experienced shingles. Follow-up would not be possible as no contact details available. The case was linked with case US2021AMR190802 reported for 2nd outbreak of shingles,reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR190802:Same reporter.
had gradual onset of sore red lump up to diameter of 4" w/max on 18NOV today feels it is less;