chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt presented 24 hours after 2nd dose with 10 cm area of erythema, increased heat and swelling. Lasted for 3 days. Reactions completely resolved on 10/27/03.
HAD BEEN INJURED BY VACCINE; This spontaneous report received from a consumer via a company representative concerned multiple patients.  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) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced had been injured by vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of had been injured by vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211052831 and 20211051962.
Fever, chills, body aches, headache, swollen arm and  large rash on arm (Covid Arm)
Information has been received from a registered nurse concerning an 8 year old patient who was vaccinated with a second dose of Varivax. On an unspecified date, the patient developed redness and swelling of a 4.5 cm area and pain. No further information is available.
77 year old male was vaccinated with RSV vaccine or placebo and Influenza vaccine on 10/28/02 and 60 days later collapsed and died at home while showering. It was stated that the patient apparently died of cardiac arrhythmia. Relevant medical history includes a pacemaker in 1995, atrial fibrillation, angina, MI in 1991 and COPD. The subject was unblinded at the request of the investigator for documentation in view of organ donation. The participant received the RSV vaccine. The investigator assessed the event as unrelated to the study products. Additional information received on 12/17/04: The subject collapsed and died at home while showering. Apparently, the cause of death was cardiac arrhythmia. No death certificate is available. Additional information received on 12/20/04 from the investigator: The lot number for the study product was verified to be the same as the subject number and it was confirmed that this subject was unblinded.
Injection site swelling (~2" Diameter), muscular twitching,  nerve irritation. No treatment to date.
Information has been received from a 24 year old female medical assistant, reporting about herself, with drug reactions and allergies to BACTRIM and Sulfa and a medical history of HPV virus, who on an unspecified date, "about 2 months ago", in approximately November 2011, was vaccinated with the first dose of GARDASIL, (dose, route, lot number were not reported). There was no concomitant medication. "About 2 months ago", in approximately November 2011, one week later from receiving the first dose of GARDASIL, the patient developed "urticaria" from her face to her feet and angioedema on her lips, face and around her eyes. Medical assistant also reported that her throat was "itchy". On an unspecified date, the patient went to the Emergency Department at hospital and was treated with 50 mg of PREDNISONE (manufacturer unspecified), BENADRYL (manufacturer unspecified and dose unspecified) and an epinephrine injection (manufacturer unspecified and dose unspecified). On an unknown date, the following day, the patient had to return to the Emergency Department at hospital (second visit), because the "urticaria' from her face to her feet, the angioedema on her lips, face and around her eyes, and her throat itchiness had became worse. Medical assistant reported that on her second visit to the Emergency Department at hospital, she received another dose of PREDNISONE 50 mg (manufacturer unspecified), BENADRYL (manufacturer unspecified and dose unspecified) and an epinephrine injection (manufacturer unspecified and dose unspecified). The patient took a one week course of oral PREDNISONE after she was discharged from the Emergency Department. Medical assistant report that all the symptoms completely subsided 1 week after the symptoms first appeared. Medical assistant mentioned that on an unspecified date in the past, her physician believed laundry detergent caused her to have "urticaria" from her face to her feet, angioedema on her lips, face and around her eyes. The reporter mentioned that she had stopped using that laundry detergent prior to receiving GARDASIL. No laboratory diagnostics studies were performed. "Urticaria" from her face to her feet, angioedema on her lips, face and around her eyes and her throat itchiness were considered to be immediately life-threatening and an other important medical event by medical assistant due she received epinephrine. Additional information has been requested.
arm soreness cont now 6wks p/inj; neg exam; 5MAY95 no response to f/u request;
First 24 hours  -   6 hours after shot - headache, arm so sore couldnt sleep on it 36 hours - tired. flu like symptoms - skin tender to touch, irritable, arm better 48 hours - woke up  .- 3am -sweated through my pjs and sheets.  Woke up at 8am and had hives all over my legs, arms, back of neck.  Shot arm (left) and right arm  had big patch of puffy red hive marks. My legs inside/out had  individual puffy bumps all over.  My arms had fewer marks and less puffy.  My neck red and puffy.  My stomach and chest did not have any. NOT really itchy at all.
Arm swelled up 2 hours after shot. Sense of taste lost, metallic taste  in the evening of the day of vaccination. Fingertips and throat swollen a day after. Patient also reports felt itchy all over. Patient reports having used Benadryl which helped but was allergic to that also as she experienced a feeling of welling in the throat. Patient reports has EpiPen but expired but didn't need to use it. Patient also reports has consulted with multiple doctors to see what the issue is and felt that it might have been PEG polyethylene glycol
After 15mins client was  ready to walk out and complained of dizziness as she was ready to leave. She was guided to the fainting chair and a set of vials were taken. BP 128/76. Client declined to drink water because she felt nauseous. Client complained of Light -headedness, mild dizziness, tiredness.  She had no episode of syncope. She refused to stay for the additional 30mins due to her ride leaving soon and  stated she felt better. She was recommended to follow up with her Primary care provider and recommended to seek Emergency care if she didn't feel better or reactions worsened. Client verbalized understanding. She left in no apparent distress
Information has been received from a nurse practitioner concerning a 12 month old patient who on "ten days ago" approximately 13-Oct-2006 was vaccinated with a 0.5 ml dose of ProQuad (upgrade process). Suspect vaccination administered that day included a dose of influenza virus vaccine (unspecified). "Ten days ago" on approximately 13-Oct-2006 the patient developed a fever, rash, cold symptoms and conjunctivitis. Subsequently, the patient recovered. Unspecified medical attention was sought. There was no product quality complaint involved. Additional information has been requested.
Nightmares and sleep deprivation; Nightmares and sleep deprivation; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Mar-2021 and was forwarded to Moderna on 29-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of NIGHTMARE (Nightmares and sleep deprivation) and SLEEP DEFICIT (Nightmares and sleep deprivation) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced NIGHTMARE (Nightmares and sleep deprivation) and SLEEP DEFICIT (Nightmares and sleep deprivation). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, NIGHTMARE (Nightmares and sleep deprivation) and SLEEP DEFICIT (Nightmares and sleep deprivation) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was provided.
Anxiety; Lot of stress; Sick/felt like had mono after COVID vaccine; Sick/felt like had mono after COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (Anxiety), STRESS (Lot of stress), INFECTIOUS MONONUCLEOSIS (Sick/felt like had mono after COVID vaccine) and ILLNESS (Sick/felt like had mono after COVID vaccine) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Hidradenitis suppurativa.    Concurrent medical conditions included Hidradenitis suppurativa (Moderate to severe hidradenitis suppurativa).   In September 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In September 2021, the patient experienced INFECTIOUS MONONUCLEOSIS (Sick/felt like had mono after COVID vaccine) and ILLNESS (Sick/felt like had mono after COVID vaccine). On an unknown date, the patient experienced ANXIETY (Anxiety) and STRESS (Lot of stress). At the time of the report, ANXIETY (Anxiety) and STRESS (Lot of stress) had not resolved and INFECTIOUS MONONUCLEOSIS (Sick/felt like had mono after COVID vaccine) and ILLNESS (Sick/felt like had mono after COVID vaccine) had resolved.            No concomitant medication was reported. No treatment medication was reported.  In 2021, the sick/felt like had mono after COVID vaccine resolved.  It was unknown if patient was enrolled in a COVID-19 vaccine trial.  The reporter's causality for the events of sick/felt like had mono after COVID vaccine with Humira (adalimumab) was no reasonable possibility. The reporter's causality for the events of anxiety and lot of stress was not provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
lip swelling; lip tingling; lump in her neck; facial swelling; arm pain; A spontaneous report was received from a physician concerning a 40 year old female patient who experienced arm pain, lip swelling, facial swelling, lip tingling, and lump in her neck with the use of mRNA-1273.    The patient's medical history included Ankylosing Spondylitis and on immunosuppression due to her condition.  Concomitant medications included hydrocortisone, buprenorphine, diltiazem and duloxetine. Two other drugs were doubtful(Agent not heard properly).  On 05 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly, for prophylaxis of COVID-19 infection.  On the night of 05 Jan 2021, the patient experienced the non-serious event of arm pain, which went away. On 08 Jan 2021, the patient experienced lip swelling and tingling, and a lump in her neck. It was noted the patient is on a lot of medication because her condition is immunosuppressive. The physician inquired if the patient can receive prednisone for reported events and how would it affect the second dose. It was not confirmed whether the patient received treatment with prednisone. Treatment included diphenhydramine hydrochloride and famotidine.  Action taken with mRNA-1273 in response to the event was not provided.  The event of arm pain recovered on an unspecified date. The events of facial swelling, lip swelling and tingling, and a lump in her neck were not recovered/not resolved.; 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.
first dose on 6/10/2021, has not received second; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 57-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in right arm on 10th June 2021 of batch number 44DX0 and 28th October 2022).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 27-JUL-2022 Reporter's comment: The pharmacist reported that at the time of reporting the patient had not receive the second dose of the Shingrix vaccine. The reporter consented to follow-up. Additional supportive information: Till the reporting the patient did not receive the second dose of Shingrix vaccine, which led to incomplete course of vaccination.
Daughter reported that beginning 1-23-2021 after vaccine, patient experienced a red, swollen arm. Swelling present down to elbow of right arm. From 1-24-2021 to 2-6-2021, patient experienced diarrhea and fever. Daughter was concerned that patient was becoming dehydrated so patient was given IV fluids for replenishment. Facility where fluids received and length of stay in facility are unknown at this time.
Low grade fever to 100.4, bilateral red cheeks, then reticulated rash within 3 days of vaccines above.  Then resolved, then on 12/11/20, bilateral red cheeks again, pink papular rash on body.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 04Jan2021 at 10:00 as dose 1, single (Lot number: EJ1685), in left arm, on 25Jan2021 at 10:00 as dose 2, single (Lot number: FL1283), in left arm and on 04Oct2021 at 11:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 44 years, in left arm for covid-19 immunisation. The patient's relevant medical history and 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 "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (16May2022) Positive, notes: Test positive for COVID19 via binaxx2 and confirmatory PCR x1 Monday May 16th. Mild symptoms of sore throat, cough and rhinorhea; (20May2022) Negative, notes: Was test negative Binax beginning Friday May 20th, Saturday May 22nd and Tuesday May 24th; (22May2022) Negative, notes: Was test negative Binax beginning Friday May 20th, Saturday May 22nd and Tuesday May 24th; (24May2022) Negative, notes: Was test negative Binax beginning Friday May 20th, Saturday May 22nd and Tuesday May 24th; (30May2022) Positive, notes: Monday May 30th, COVID19 tests via binax x2 were again positive with PCR comformatoty positive in the settings of mild symptoms (sore throat, cough, rhinorrhea). Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Mild symptoms of sore throat, cough and rhinorrhea. Started Paxlovid same evening (Monday 16May) and completed series Saturday 21May. Test was negative Binax beginning Friday 20May, Saturday 22May and Tuesday 24May. Monday 30May, COVID19 tests via Binax x2 were again positive with PCR conformity positive in the settings of mild symptoms (sore throat, cough, rhinorrhea). Monday 30May is 9 days post last date of Paxlovid dose. Known allergies: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: As there is limited information in the case provided, the causal association between the events Drug ineffective and Covid-19 and the suspect drug cannot be excluded. The case will be reassessed once new information is available.
abrupt onset of abdominal pain that caused her to go home from work.  The following morning at 5:30 a she woke up with a swollen face, lips, periorbital region. No swelling of tongue, uvula or pharynx. Urticaria on arms. Resolved without therapy within 8 hours. Advised to NOT take ANY aspirin products and to stop losartan.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A 79-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 22Jan2021 at 13:15 as dose 1, single (Lot number: EL3246), in left arm, on 12Feb2021 at 12:30 as dose 2, single (Lot number: EL3246), in left arm, on 13Oct2021 at 10:15 as dose 3 (booster), single (Lot number: FP2589), in left arm and on 13Apr2022 at 12:00 as dose 4 (booster), single (Lot number: FJ5683) at the age of 79 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant) with onset Jul2022, outcome "unknown", COVID-19 (medically significant) with onset Jul2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (12Jul2022) positive, notes: Symptoms returned 5 days after completion of Paxlovid treatment. Have continued to test positivity since onset of first positive test on 12Jul2022. Therapeutic measures were taken as a result of vaccination failure, covid-19. Clinical course: The patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The patient was previously receive a COVID-19 Vaccine. No known allergies reported. No drug as reported and reaction: Allergy. No hospitalization prolonged.; Sender's Comments: Based on the information available  a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported events of vaccination failure,covid-19.
chills, headache, extreme tiredness, low grade fever - I felt like I had the flu
side effects unspecified; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects unspecified) 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 VACCINATION COMPLICATION (side effects unspecified). At the time of the report, VACCINATION COMPLICATION (side effects unspecified) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications was not provided by the reporter Treatment information was not provided
Vertigo with vomiting started 2 days post and have continued for 1 week.   Vomiting has subsided but vertigo continues    No successful treatment yet
SWEATING; CLUSTER OF RASHES ALL OVER BODY (SHOULDER BLADE, LEFT BICEP, RIGHT FOREARM IN LEFT BICEP, RIGHT FOREARM, UPPER THIGHS, ON TOP OF HEAD, INSIDE OF ARM AND ON BACK ALL OVER THE BODY) THEY ARE ITCHY WHEN SCRATCHED; HIVES ALL OVER THE BODY; This spontaneous report received from a patient concerned a male 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: 1805022 and expiry: 21-MAY-2021) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On an unspecified date, the subject experienced sweating, cluster of rashes all over body (shoulder blade, left bicep, right forearm in left bicep, right forearm, upper thighs, on top of head, inside of arm and on back all over the body) they are itchy when scratched, and hives all over the body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from cluster of rashes all over body (shoulder blade, left bicep, right forearm in left bicep, right forearm, upper thighs, on top of head, inside of arm and on back all over the body) they are itchy when scratched, and the outcome of sweating and hives all over the body was not reported. This report was non-serious.
Less than one minute after vaccines were administered patient was seated on examination table and lost consciousness and fell head first off the table, hit his head on a chair next to the examination table and then fell supine onto the floor.  At this point the patient showed some seizure like activity for less than 20 seconds with eye rolling and rapid movements of legs and arms.  The left central top incisor tooth was chipped and placed in normal saline and ice was applied to patients nose which was swollen.  Patient regained consciousness scared and nauseous. 911 was called at the onset of the fall and appeared at the office 5-10 minutes after patient was recovered but left supine on the floor.  EMT's brought patient to feet and he was brought to ER.