chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Breakthrough case admission after 2 vaccines Pfizer 4/5/21 lot# ER8727;  Pfizer 4/27/21 lot# EW0164
Approx 30 hrs after receiving vaccines client noticed erythema & felt slight tenderness at left deltoid.  At 48 hrs following injections she noticed increased erythema & tenderness & discomfort when arm was moved.  Erythema was spreading into axillary area.  10/17/08 clt seen by physician who presented antihistamine, generic KEFLEX & dose pack of CORTISONE.  Client started meds immediately; has 2 more days, no signs/symptoms remain.
I had severe flare ups from Rheumatoid arthritis after both vaccine shots were given. It has taken me over a month to recuperate and to this day I am still not back to how I was before the vaccine. I had high fevers of 102 for about 2 days and then low grade fever with both shots.
Initial report received on 25 May 2011 from an investigator participating in a trial. A four-year-old male subject (initials not collected) with a medical history of febrile seizures (inactive since 2008) experienced a febrile seizure due to high fever one day after receiving a first dose of either INFLUENZA VIRUS VACC QUAD A & B or INFLUENZA VIRUS VACC NO PRESERV. TRIVAL A&B SV-U ALT-B or FLUZONE No Preservative 2010-2011 (route and site of administration not reported) on 03 February 2011. Lot number was not reported. The subject's mother noted a mild episode of fever with febrile seizure that lasted only a "couple of minutes". Treatment included MOTRIN 200 mg x 1. After the one treatment the fever and seizure subsided without reoccurrence. The subject had a subsequent second dose of trial product on 03 March 2011. The seriousness was reported as Other: Important medical event specify event of special interest. The subject was not discontinued from the trial. The outcome was reported as recovered. According to the investigator the event of febrile seizure (due to high fever) was related to the trial product but was not related to the trial procedures. Documents held by sender: none.
In the week following administration of my first Covid shot, I developed significant, persistent, and unusual (for me) constipation, which has only begun to go away now that I am 8 weeks out from the shot.  As a woman going through menopause, I also resumed having hot flashed multiple times a day (these have also not gone away, 8 weeks out) within days of receiving the shot, despite their being absent prior to vaccination, for several months.
Patient had pain & swelling of shoulder where injection was administered, and was unable to lift arm by herself.
Two days post vax, the pt experienced a severe headache, joint pain, and joint swelling. The symptoms were treated with acetaminophen, ibuprofen, and bed rest. It was reported the pt could not work for approximately one week. Lymerix was discontinued. The information received on 9/19/00 reported the symptoms resolved and the pt is now healthy. This report was considered incapaciting as the pt could not work for approximately one week. Additional information has been requested.
Pain, Redness at Injection Site day 1-4, Itching and  Redness at Site day 5-7 Narrative:  Other Relevant History:
This patient was given TriHibit in the left thigh. The night following his immunization the site was red, swollen, hot to touch, itchy, and diameter size of a baseball. The patient was put on antibiotics for treatment.
Patient states noticed a bump developed at injection site which was red . He believed I gave this injection Subcutaneously rather than IM.  I am very sure I gave IM  with right technique. other than that he did not mention any other adverse event.
Information has been received from a health professional concerning a female patient who in 2001 was vaccinated with a dose of varicella virus vaccine live. Recent titers did not show seroconversion. Unspecified medical attention was sought. No product quality complaint was involved. Follow-up information indicated that no additional information was available or expected from this location.
Previous neuropathy worsened; Previous neuropathy worsened; Slight sore throat; Feeling horrible; Hard to walk; Blood pressure is high; Swollen gland (on my right side); Skin is itchy; Arm skin is breaking out; Severely fatigued; Muscle aches; Joints are aching; This serious initial spontaneous safety report was received by Novavax on 17-JAN-2023 from a consumer via a contact center.   A female of 82 years was vaccinated with intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 1 on 21-NOV-2022 on the left side, intramuscular Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL suspect Covid-19 vaccine Dose 2 on 22-DEC-2022 on the right side at a pharmacy.  Medical history was reported as Renal cancer (kidney lymphoma in 2010, been in remission for 2 years) Gluten sensitivity (Wheat sensitive, individual does not have celiac disease but avoids gluten and sugar) and Hypertension.  Concomitant medications were reported as losartan (25 mg) and levothyroxine (25 mg).   On an unspecified day in DEC-2022, after second dose of the vaccination the individual experienced feeling horrible (PT: Feeling abnormal), severely fatigued (PT: Fatigue), swollen gland (on my right side) (PT: Lymphadenopathy), a slight sore throat (PT: Oropharyngeal pain) and can barely get out of bed. With these symptoms coming after the vaccine, the individual was very disturbed. The individual called their PCP (primary care physician) already and let them know. The individual experienced skin was itchy (PT: Pruritus), arm skin was breaking out (PT: Rash), muscle aches (PT: Myalgia), hard to walk (PT: Gait disturbance), blood pressure high (PT: Hypertension), joints aching (PT: Arthralgia) and the individual experienced previous neuropathy associate with their lymphoma that seemed to worsen (PT: Neuropathy peripheral) (Serious: Medically Significant) (PT: Condition aggravated).  Relevant lab tests included: SARS-CoV-2 test (Result: Positive; 09-FEB-2022).  At the time of reporting, the event outcomes of Fatigue, Lymphadenopathy, Oropharyngeal pain, Pruritus, Rash , Myalgia, Gait disturbance, Hypertension, Arthralgia, Neuropathy peripheral and Feeling abnormal were unknown.; Sender's Comments: This 82 year-old female experienced: Condition aggravated, Neuropathy peripheral, Arthralgia, Fatigue, Feeling abnormal, Gait disturbance, Hypertension, Lymphadenopathy, Myalgia, Oropharyngeal pain, Pruritus and Rash after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The events Condition aggravated and Neuropathy peripheral were assessed as serious. The events Arthralgia, Fatigue, Feeling abnormal, Gait disturbance, Hypertension, Lymphadenopathy, Myalgia, Oropharyngeal pain, Pruritus and Rash were reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.
Presented to the ED 7 days after testing positive for COVID-19 with shortness of breath on 4/4/21. Was treated with bamlanivimab and discharged home.  Presented to to ED on 4/6/21 with worsening symptoms and was admitted to hospital. Currently still admitted.
Passed out; Hypotensive; Lightheaded; Heart rate dropped to 50; Arm  soreness; A spontaneous report was received from a consumer concerning a 43-year old, male patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced passed out, hypotensive, lightheaded, heart rate dropped to 50 and arm soreness.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Jan 2021, approximately 0 days prior to the onset of the events, the patient received a dose of mRNA-1273 (Batch number 011L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 23 Jan 2021, 6 minutes following vaccination, the patient experienced lightheadedness, became hypotensive, heart rate dropped to 50, and he passed out. Following the events, ambulance came and he was rushed to a health clinic. They gave him an Epinephrine shot and his vitals stabilized quickly. The patient also had arm soreness. Treatment for the event included epinephrine.   Action taken with mRNA-1273 in response to the events was not reported.  The events passed out, hypotensive, lightheaded, heart rate dropped to 50, were considered resolved on 23 Jan 2021. The outcome of the event arm soreness was unknown.; Reporter's Comments: Company comment: This spontaneous report concerns a 43-year old, male patient who experienced serious event of passed out and nonseries events of hypotensive, lightheaded, heart rate dropped to 50 and arm soreness.  The events occurred on the same day, 6 minutes after the administration of the first dose of mRNA 1273 (lot number 011L20A, expiration date unknown). Treatment included epinephrine and outcome of all events except arm soreness are resolved.  Based on the information provided, which indicates a temporal association of the reported events with the administration of mRNA-1273 vaccine, a causal association cannot be excluded.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. On 29-MAY-2015, the patient was inoculated with ZOSTAVAX at a Clinic for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster. In 2016, the patient was treated by a physician and was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, 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, including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life, increased risk of premature death, aggravation of pre-existing conditions and activation of latent conditions; lost wages; loss of earnings capacity, and other losses and damages. And pain and suffering, and other damages. At the time of the report, the outcome of the aforementioned adverse events was unknown, excepting for the events of emotional distress and pain that was reported as not resolved. The relatedness assessment between the aforementioned adverse events and ZOSTAVAX was related. The reporter considered the events as serious for the following reasons: Hospitalization, life-threatening, disability and medical significant.
Per patient's provider, patient had a delayed hypersensitivity reaction last night.  Left deltoid with 5 cm x 6 cm area of erythema.   It started with itching last night.
Right leg abscess- rx for antibiotics. MD at Children's told her it was from the shots.
Tested positive for Covid; over the counter treatments; tested negative two weeks later from onset; symptoms: tiredness, headaches, sore throat and cough (which continues to persist)
2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022); 2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022); This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022)) and PRODUCT STORAGE ERROR (2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022)) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 083J21A, 014F21A, 030A21A and 031M20A) for COVID-19 vaccination.     Concomitant products included BICALUTAMIDE from 14-Mar-2022 to an unknown date, LISINOPRIL from 17-Jan-2022 to an unknown date and AMLODIPINE from 06-Feb-2020 to an unknown date for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 06-May-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022)). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022)) and PRODUCT STORAGE ERROR (2 booster doses (0.25mL) of expired Moderna Covid-19 vaccine were administered today (06May2022)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   On 10-May-2022,  MOD-2022-560476 became Invalid as one criteria was missing for valid case that was identifiable patient(2 patients). Hence processed this case as invalid only.  The vial was initially stored in the refrigerator on 05-May-2022 The vial did not undergo any temperature excursions. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 06-May-2022: Follow-up received contains no new information. On 19-May-2022: Follow up received on 19/May/2022: Upon follow up the case was became valid. Follow up received includes Patient details, Dose details, Dose expiration date, Concomitant medications, Case Narrative updated
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Mar2021 09:00 (Lot number: EN6206) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Graves' disease" (unspecified if ongoing), notes: other medical history: Graves' disease; "high blood pressure" (unspecified if ongoing), notes: other medical history: high blood pressure. Concomitant medication(s) included: LEVOTHYROXINE; ENALAPRIL. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021 13:00, outcome "unknown", described as "sore arm". Therapeutic measures were not taken as a result of pain in extremity.  No follow-up attempts are possible. No further information is expected.
suspected vaccination failure; got the shingles; still suffer nerve damage; This case was reported by a consumer and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and nerve damage. On an unknown date, the outcome of the vaccination failure and shingles were unknown and the outcome of the nerve damage was not recovered/not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and nerve damage to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The age group was captured as an adult as per vaccine indication. The patient had shingle vaccine and still got the shingles.  The patient was still suffering nerve damage.  The patient stated that commercial was misleading because you can still get the shingles even if you get the vaccine. The reporter consented to follow up. This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting.
Headache, NauseaVomiting, fatigue, injection site pain Narrative:  Employee reported injection site pain 1/25/2021 and 1/26/2021. Nausea 1/26/2021. Headache and fatigue 1/26/2021 and 1/27/2021. Resulted in unable to work 1/26/2021 and 1/27/2021.
Patient was ordered a dose of FLUAD high-dose influenza vaccine 2023-2024 with an intramuscular route of administration. Nurse administered the prefilled vaccine syringe via the intravenous route on 9/10/23. Patient was discharged from the hospital on 9/11/23 with no documented adverse effects from the incorrect route of administration. Patient was admitted to the hospital for nausea, vomiting, and abdominal distension. She had sigmoidectomy with end colostomy on 9/6/23.
Client complained of "tongue feeling tight" and "metallic taste" approximately 15 minutes after 2nd COVID vaccine injection.  She was assessed, had no other symptoms - no SOB, no itching, no chest pain, etc.  She waited in the clinic area over an hour after she was provided Benadryl liquid 25 mg po.  She sat quietly reading a book and was able to drink a bottle of water.  Per nurse's recommendation, her sister presented to the office to escort her home.  She left the office walking and talking without any problems.  BP prior to leaving the office was 126/89, pulse 85.
Fatigue, slept for 24 + hours, body aches, chills, fever, nause and vomiting.
Information has been received from a nurse practitioner referring to an 18 year old male patient with autism, gout, atopic derm and no known drug allergy. The patient had no illness at time of vaccination. Concomitant therapies included hepatitis b virus vaccine (unspecified), hepatitis a virus vaccine (unspecified), poliovirus vaccine inactivated (unspecified), VARIVAX and diphtheria toxoid (+) tetanus toxoid. On 02-MAY-2016 at 12:25, the patient was vaccinated with M-M-R II lot # L026553 dose 2, subcutaneously in the left arm. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
This spontaneous report as received from a licensed practical nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' medical history and concurrent conditions was provided. On unknown dates, the patients received unspecified doses GARDASIL, lot number reported as L048459, expiration date: 22-FEB-2018 and lot number reported as M007728, expiration date: 21-MAR-2018, (dose, route of administration and injection site were not provided). There were no concomitant medications reported. It was stated that the vaccine underwent a temperature excursion of 49.1 degrees Fahrenheit for 1 hour 7 minutes. The excursion was captured using digital data logger. No previous temperature excursion was reported. No adverse effects were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sudden onset embolic stroke requiring embolectomy two days following first dose of moderna vaccine. Successful clot removal, but residual small stroke causing left-sided weakness.
Increased swelling and pain at the site to size of egg with redness extending down left arm nearly to elbow over 5 days following injection. Did not subside for approximately 10 days and has left continued sore spot at injection site. Also, accompanied by temp 101.4 times 24 hours followed by gen. malaise day 2 till evening.
No pain at injection site. Redness approx 1/4" wide & 1/2" long leading over to large area of redness measuring 4cm x 4cm. Inflammation, swelling (very hard area) & pain at the 4cm x 4cm area. Periodic headache for 2 days. Swelling started decreasing on day 4 et redness also started decreasing on day 4. Some swelling remains on day 5.
tongue was swollen; also the eft side of his mouth.; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (tongue was swollen) and MOUTH SWELLING (also the eft side of his mouth.) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Blood pressure high since an unknown date, Heart attack since an unknown date and Kidney absent.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced SWOLLEN TONGUE (tongue was swollen) and MOUTH SWELLING (also the eft side of his mouth.). At the time of the report, SWOLLEN TONGUE (tongue was swollen) and MOUTH SWELLING (also the eft side of his mouth.) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medications included medicines to treat heart blocked, High blood pressure medications and diuretics. Treatment information was not provided.
Dizzy Shortness of breathe upper abdominal pain Rash across chest Felt weird The following day went to see cardiologist on 01/29/2021 EKG was done and came back noemal. Determined to be a reaction to the vaccine. Encouraged to get the second shot.  01/29/2021 I was feeling better after seeing the cardiologist.
Onset abdominal cramping for 2-3 hours, chills, cold sweats, nausea and vomiting - denies other complaints.
This spontaneous report was received from a medical assistant and refers to a unspecified number of patients of unknown age and genders. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. Approximately in 2016 (reported as "starting 23-AUG-2016 to present, 08-SEP-2016"), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB which had a lot # of M022077, with an expiration date of 10-MAR-2019 and lot # of M006708 and an expiration date of 02-JUN-2018 (route, concentration, dose number, dose and anatomical place of vaccination were not provided). Which were exposed to a temperature of 0.3 C for 5 hours and 5 minutes, and a data logger was involved. Nevertheless, no adverse effects were reported and no product quality complaint was involved. This is one of several reports from the same reporter. Additional information has been requested.
I experienced red, irritated eyes following the vaccine. Also experienced a blister likely chemosis which lasted approx 1 day.
Pt recvd 3 doses of Engerix-B 09MAR90, 13APR90 & 17SEP90 & it was determined that pt failed to seroconvert;
dermatological infection leading to intense painful cystic acne,  prescribed Cephalexin for treatment and it did nothing. Still suffering and progressively getting worse
Pain in arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovering", described as "Pain in arm". It was unknown if therapeutic measures were taken as a result of pain in extremity.  Additional information: It was unknown if the any other vaccine was received in four weeks and other medications in two weeks. Prior vaccination, it was unknown if patient had COVID-19 and post-vaccination, it was unknown if COVID-19 was tested.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.