chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial unsolicited report received from a pharmacist on 30 Sep 2016. This case involves a 67 year old female patient who was vaccinated with a dose of FLUZONE HD, FLUZONE QIV both were administered intramuscularly and PNEUMOVAX 23 route unknown, (Batch number, expiry date, dose and site of administration was not reported for all vaccines) on 22 Sep 2016. The patient had a medical history of nickel allergy, diabetes (PMH) and hypertension the patient illness at the time of vaccination and any other vaccinations within four weeks of vaccinations were not reported. The patient concomitant medications were not reported. On an unspecified date reported as 2-3 days later following the vaccination the patient experienced nausea, vomiting, diarrhea, itchiness and burning of face and redness and itchiness at injection site. The patient was seen by the physician on an unknown date (reported as after evaluation "the physician said that the patient was fine). The patient's lab tests and corrective treatment was not reported. The outcome of the events were reported as unknown. List of documents held by sender: none.
strokes; brain bleed; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (strokes) and CEREBRAL HAEMORRHAGE (brain bleed) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (strokes) (seriousness criterion medically significant) and CEREBRAL HAEMORRHAGE (brain bleed) (seriousness criterion medically significant). At the time of the report, CEREBROVASCULAR ACCIDENT (strokes) and CEREBRAL HAEMORRHAGE (brain bleed) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.  Reporter spoke to reported some people that have received Moderna's COVID-19 vaccine experience strokes and brain bleeds. Also stated that other people reported they had a lot lately and at a "much higher quota than normal", brain bleeds also happened in nursing homes.  Company Comment: This case concerns a patient without identifiers and no relevant medical history reported, who experienced the unexpected events of cerebral vascular accident and cerebral haemorrhage. The event occurred after a dose of mRNA-1273 Moderna vaccine (SD doesn´t clarify if it was 1st or 2nd dose, vaccination date was not provided, onset of events was not provided) . The rechallenge is N/A (no information regarding other dose was provided)  The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report. Very limited information regarding this events has been provided at this time. Further information has been requested.; Sender's Comments: This case concerns a patient without identifiers and no relevant medical history reported, who experienced the unexpected events of cerebral vascular accident and cerebral haemorrhage. The event occurred after a dose of mRNA-1273 Moderna vaccine (SD doesn´t clarify if it was 1st or 2nd dose, vaccination date was not provided, onset of events was not provided) . The rechallenge is N/A (no information regarding other dose was provided)  The benefit-risk relationship of mRNA-1273 Moderna vaccine in not affected by this report. Very limited information regarding this events has been provided at this time. Further information has been requested
Pt has hx of rash on bil arms with her first dose of Moderna and she denies no other reactions including shortness of breath , chest pain, dizziness, headaches, fever, difficulty breathing, dyspnea,dysphagia or wheezing. Pt does notes to have underlying dysphagia which is a chronic issue for pt.  Today pt was here for her second Moderna Imm which she tolerated well but at 0845 am reported mild headache which to her seemed similar to her previous migraine headaches which she gets off and on . Denied any nausea vomiting, dizziness, chest pain, shortness of breath, dysphagia, dyspnea, wheezing or coughing or difficulty breathing.  Pt was given water and crackers which helped her sx immediately.  BP: 134/83 HR: 76 O2: 98% RR: 17.  Neuro: pt A&O and able to follow instructions.  Pt was monitored for 40 mins total and she left in stable condition.ER precautions were given to pt incase she has any worsening of sx, shortness of breath, chest pain, wheezing , difficulty breathing. She reported understanding.
Pt was given hep A and flu vaccines on 10/12/17 and then on 10/13 the next day, pt had eye swelling unchanged until 10/14 (two days after getting vaccines) pt then had facial swelling. Per mom, pt had forehead swelling what looked like two lumps per mom and then swelling to lower leg. Pt was taken to MC on 10/13. ER per mom not sure if vaccines caused swelling but advised not to have vaccines again in future.
NO ADVERSE REACTION NOTED, PATIENT ACCIDENTLY RECEIVED HEP A VACCINE INSTEAD OF THE INTENDED HEP B VACCINE. NO ADVERSE REACTIONS EXPECTED AS HEP A VACCINE CAN BE GIVEN IN CHILDREN AS EARLY AS 6 MONTHS OF AGE
10 minutes after vaccination, client's transport observed increased coughing.  client given water.  a few minutes later client vomited twice, coughing increased.
Patient reports fever, fatigue, nausea and a large red area around/near injection site.
received a dose of Boostrix instead of a dose of Infanrix; received a dose of Boostrix / DOB 08-DEC-2014; This case was reported by a nurse via call center representative and described the occurrence of accidental underdose in a 6-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number CM7KN, expiry date unknown) for prophylaxis.   On 14th April 2021, the patient received Boostrix (intramuscular). On 14th April 2021, unknown after receiving Boostrix, the patient experienced accidental underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the accidental underdose and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The nurse reported that 6 year old patient received a dose of Boostrix instead of a dose of Infanrix vaccine, which led to accidental underdose and inappropriate age at vaccine administration. The reporter consented to follow up. The reporter did not have the expiration date for the product. No further information provided. This case was linked with case US2021129089, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021129089:same reporter
I had a cough, fatigue, headache, body aches, and runny nose. I tested positive for COVID-19. I talked to a doctor, and I was prescribed Paxlovid. I was coughing for a couple of weeks.
Pt received adult dose (0.5ml) instead of ped dose (0.25ml).  No reaction noted after administration.
This case was reported by a consumer via call center representative and described the occurrence of sickness in a elderly female patient who received SHINGRIX for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. In August 2018, the patient received the 1st dose of SHINGRIX. In October 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season. In October 2018, less than a year after receiving SHINGRIX and less than a month after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced sickness, tooth infection and cold. On an unknown date, the outcome of the sickness, tooth infection and cold were not reported. It was unknown if the reporter considered the sickness, tooth infection and cold to be related to SHINGRIX and Influenza vaccine Quadrivalent 2018-2019 season. Additional details were provided as follows: The reporter was patient's husband, who also had received 1st dose of SHINGRIX in August 2018, but they thought, it was October 2018. In October 2018, the patient also received flu vaccine. In October 2018, less than a year after 1st dose of SHINGRIX and less than a month after flu vaccine, the patient got sick, with a cold and then a tooth infection that required a root canal because it took so long to figure out what was going on. The patient was so ill, hence she waited and at the time of reporting, it had been 8 months after 1st dose of SHINGRIX and the patient's husband wondered if the patient could get 2nd dose of SHINGRIX. The reporter consented to follow up.
blood clots in my Lungs.. pulmonary embolism. had a catscan. and blood thinner at hospital treatment from june 9-till june11. was discharged. had to go too the emergency room with pain in my left side of chest. then they found blood clots..
devel fine, red rash on neck, shoulders, & back of head; coallesed to solid red area on back of neck;
Nausea for several hours partially relieved with antacid and ginger ale.  Symptoms subsided the next morning.  Soreness at injection site for two days.
Patient received dose 1 on 11-Jan-2021 and dose 2 on 08-Feb-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 11-Jan-2021 and dose 2 on 08-Feb-2022) in a 53-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 031l20a and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Fruit allergy (Orange), Allergy to vaccine (Pneumococcal 23-valent polysaccharide vaccine), Allergy to antibiotic (Rocephin) and Seafood allergy (Shrimp).   On 11-Jan-2021 at 10:36 AM, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) .5 milliliter. On 08-Feb-2022 at 5:44 PM, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 08-Feb-2022 at 5:44 PM,  after starting mRNA-1273 (Spikevax), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 11-Jan-2021 and dose 2 on 08-Feb-2022). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received dose 1 on 11-Jan-2021 and dose 2 on 08-Feb-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that patient did not experience any adverse event including signs and symptoms, clinical course or treatment with date or timelines.  No treatment medications were reported.   This case was linked to MOD-2022-504696 (Patient Link).
INNER EAR DAMAGE; 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 not reported, batch number: unknown, expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. The Company was unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced inner ear damage and was hospitalized (dates unspecified). The patient had a severe reaction to the J and J vaccine. She was hospitalized with repeat MRIs (Magnetic resonance imaging) and CTs (Computerized tomogram). They believed that the inner ear damage was an overreactive immune response to the J and J vaccine. It caused vestibular damage and severe swelling. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of inner ear damage was not reported. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0:20220252273-COVID-19 VACCINE AD26.COV2.S-Inner ear damage. The event(s) has a compatible/suggestive 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.
This spontaneous report was received from a pharmacist refers to a approximately 52 years old male patient with no pertinent medical history and with drug reactions/allergies to penicillin and an anaphylactic reaction to unspecified flu vaccine (MARSS # 1306USA005758. In 2007 the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (lot number and expiration date not reported). No other co-suspect therapy was provided. Concomitant medications were not reported. The pharmacist reported that the patient received pneumonia vaccine (manufacturer unknown) approximately in 2007 which caused his arm to swell up. On an unknown date, the patient recovered from the event. No laboratory tests were performed. The outcome of the patient received an unspecified pneumonia vaccine which caused his arm to swell up was reported as recovered/resolved. Additional information has been requested.
vestibular neuronitis; sudden sensorineural hearing loss; vertigo; hearing loss in the left ear / asymmetrical hearing loss; Information has been received from a lawyer regarding a case in litigation, and refers to a patient of unknown age and gender.  The patient's concurrent conditions, medical history and concomitant medications were not reported. Approximately on 24-JAN-2017 (reported as: in or around), the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (dose, route and dosage information were unknown) for routine health maintenance and prevention of shingles (herpes zoster).  On an unknown date the patient experienced vertigo, recurrent vestibular neuronitis, sudden sensorineural hearing and asymmetrical hearing loss (hearing loss in the left ear).  The adverse events were considered to be serious, progressive, permanent and incurable (disabling).  It was also mentioned that the patient suffered from physical limitations, mental and emotional distress, mental anguish, emotional distress, los of enjoyment of life, physical impairment and injury as result of the adverse events.  The causality between vertigo, recurrent vestibular neuronitis, sudden sensorineural hearing and asymmetrical hearing loss and zoster vaccine live (ZOSTAVAX) was considered to be related by the lawyer.  Upon internal review, deafness unilateral and deafness neurosensory were considered to be medically significant events.
Sore arm, vomiting, body aches, head ache, chills , slight fever, tiredness, started afternoon of vaccination and lasted for 3 days
Symptoms started on 02/06/23. There was no fever, but  there was sore throat and weakness. I was testing positive from 02/06/23 to 02/19/23. 02/20/23 was when I tested negative and continued to be negative. For treatment, the medical provider prescribed Paxlovid and I took that for 5 days.
DTaP & polio admin into (R) deltoid (DTaP) upper arm (IPV) on 10/14/11. 10/15/11 child had rash from shoulder to elbow, shoulder swollen to 2x size, hot to touch. Child brought to ER, prescribed 5 days prednisone.
Booster; achy; coughing; fever; very tired; headache; nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult female patient received bnt162b2 (BNT162B2), administration date 17Dec2021 (Lot number: Unknown) as dose 3 (booster),single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown), for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown), for Covid-19 immunization; Flu shot, for immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Dec2021, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "achy"; COUGH (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "coughing"; PYREXIA (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "fever"; FATIGUE (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "very tired"; HEADACHE (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "headache"; NAUSEA (non-serious) with onset 17Dec2021, outcome "recovered" (2021), described as "nausea". It was unknown if therapeutic measures were taken as a result of pain, cough, pyrexia, fatigue, headache, nausea.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Ear Pressure  head Pressure  heart Palpiatations  heat Sensation in Legs and Arms  Hypertension  tingling in Hands  Throat Tight  Acid Reflux  Anxiety  Muscle Weakness
side effects Almost killed my father in law; This case was reported by a consumer via interactive digital media and described the occurrence of near death experience in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   It was unknown if the reporter considered the near death experience to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, after receiving Influenza vaccine Quadrivalent unspecified season, the side effects almost killed the patient.
24 hours after getting Janssen Covid19 Vaccine patient complained of flu-like symptoms. Patient called Pharmacy 48 hours later(4/04/2021) complaining  of dripping bloody nose after blowing nose and told me of flu-like symptoms that started 4/03/21. I recommended Patient to stop bleeding by using tissue paper. After 30 minutes spoke to Patient and I was informed that bleeding stopped. He was still having moderate flu-like symptoms at the time of phone call.
pt recvd vax & had hypotension, pallor, faintness; pt dx w/ vasovagal rxn after vax; pt complained of general  weakness/body aches in days after vax, especially headache; MD said pt devel paravertebral muscle spasm w/ cold like symptoms;
Patient c/o sore arm (no redness or swelling, no other reaction) lasting three weeks after injection. Note that his other vaccine was given in the opposite arm
Asthma; lot of cough; could not sleep for 3 nights; This spontaneous case was reported by a consumer and describes the occurrence of ASTHMA (Asthma), COUGH (lot of cough) and INSOMNIA (could not sleep for 3 nights) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concurrent medical conditions included Tonsillitis.    On 31-Mar-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 ASTHMA (Asthma), COUGH (lot of cough) and INSOMNIA (could not sleep for 3 nights). At the time of the report, ASTHMA (Asthma), COUGH (lot of cough) and INSOMNIA (could not sleep for 3 nights) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug was not reported. Treatment Medications include Codeine
Hot/ cold flashes, headache, body aches, not hungry. I felt like I had the 24hr flu after my second dose of Pfizer, but this booster dose of Moderna has been way worse. Still sick and unsure how long this will last.
Patient is a 63 year old male with history of HTN, HLD, prostate CA (Gleason 7) who presented with acute onset left sided facial swelling. Patient received his flu shot at 11:00am and follow up'ed with Urology later that day. At 2:30pm the patient noted the sudden onset of left sided facial swelling that continued to worsen. He then presented to the ED for further management. He denied any difficulty breathing or difficulty swallowing. He denied any pain, numbness, or tingling. No mouth ulcers or sores. No recent illnesses, fevers, or chills. Suspect Drug #2 Dosing: TAKE ONE-HALF TABLET EVERY DAY FOR BLOOD PRESSURE/HEART. Treatment Drugs Used: 1- RANITIDINE Dose: 50 Units: MG Freq: ONCE Route: IV, 2- METHYLPREDNISOLONE Dose: 125 Units: MG Freq: ONCE Route: IV, 3- DIPHENHYDRAMINE Dose: 50 Units: MG Freq: ONCE Route: IV.
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 54-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 5 (booster), single (Lot number: FM9992) 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) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (17Feb2023) Negative, notes: After completing 5 days of paxlovid I tested positive for Covid 19 after 4 days of being negative; (18Feb2023) Negative, notes: After completing 5 days of paxlovid I tested positive for Covid 19 after 4 days of being negative; (19Feb2023) Negative, notes: After completing 5 days of paxlovid I tested positive for Covid 19 after 4 days of being negative; (20Feb2023) Negative, notes: After completing 5 days of paxlovid I tested positive for Covid 19 after 4 days of being negative; (21Feb2023) Positive, notes: After completing 5 days of paxlovid I tested positive for Covid 19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 12Feb2023 to 17Feb2023.  Clinical course: It was reported that the patient had no known allergies.
Armpit Large Swelling *** Mammogram and ultrasound performed and shows presence of 2 axillary lymph nodes demonstrating cortical thickening measuring upward of .5 cm  Nauseu, fever, loss of appetite
Myalgia, Fever,  Mild periorbital edema and pain at the insertion site. Missed work d/t to symptoms Narrative:  She took Benadryl for her periorbital edema and is follow up with primary care MD on 2/3.
Information has been received from a nurse referring to a 5 year old female patient. Information about concurrent conditions, medical history and concomitant medication was not provided. On 19-OCT-2015 the patient was vaccinated with M-M-R II (lot # J013315, expiration date 18-OCT-2015, albumin status rHA, 0.5 ml, subcutaneous in the left arm) (expired product administered). No adverse effects were reported. Additional information is not expected since there was no consent to contact physician.