chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Confluent spreading erythema and edema over left deltoid and upper arm measuring approximately 6 inches in diameter progressing over a few days. Patient was given IM injection of 125 mg SOLU-MEDROL 800mg/160mg Suflamethoxazole/Trimethoprim BID x 7 days.
Incredibly sore arm starting a couple hours after shot. Malaise and fatigue along with chills that night and into the next day. Somewhat resolved by next afternoon (time of report). Worse than post-COVID shot and significantly worse than any flu shot to date.
Arm noted to be swollen, red, warm to touch, within 24 hours after vaccine given, patient mom denied fever, no dizziness, no headache. Tx to include bactrim DS x 10 days.
Sudden onset of extreme vertigo with associated near syncope (felt like vagal). No vomiting and no real nausea. Vertigo still present but now minimal. That same night I had a mild fever, but I am not concerned by this. Had some mild vertigo after the first vaccination (lot EH9899) but it only lasted 48 hrs.
As soon as I was injected I began feeling dizzy, headachy, and queasy. These feelings have lasted a full week.
EXTREMELY HOT & SWOLLEN @ INJECTION SITE; EXTREMELY FUSSY CHILD; WHEEZING IN CHEST AFTER 24 HRS. OF VACCINATION
Narrative: COVID infection after completion of COVID vaccine series:  02/13/2021 COVID vaccine dose #1 03/13/2021 COVID vaccine dose #2 07/18/2021 Pt reported onset of congestion, dry cough, rhinorrhea,  and fever 07/19/2021 COVID positive per agency nasopharyngeal swab as requested by pt 07/20/2021 Pt reported continuation of sx and onset of myalgia and HA  07/21/2021 Pt reported onset of loss of sense of taste/smell 07/26/2021 Pt reported having been self-isolated for 11 days and w/o sx for 4 days
No additional AE reported; Nurse reports improperly stored PROQUAD was administered.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history, and drug reactions or allergies were not reported. Concomitant medications included sterile diluent.   On 13-NOV-2022, the vaccine measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) lot #W012730 with expiration date 16-OCT-2023 had a excursion of temperature -14 degree Celsius up to-10 degree Celsius (-13.7 degree Celsius) at a time frame of 5 hours 15 minutes 0 seconds, with no previous temperature excursion. On 01-DEC-2022, the patient was vaccinated with the improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) administered for prophylaxis (dosage, route of administration and anatomical location were not provided) (product storage error). No additional adverse event (AE) reported.  This is one of several reports from the same reporter.; Sender's Comments:  US-009507513-2301USA008948: US-009507513-2301USA008846: US-009507513-2301USA009147:
Swelling inside your mouth, around your neck.; Swelling inside your mouth, around your neck.; Some facial swelling; little in my face but lips now particular; This is a spontaneous report from a contactable consumer. This consumer (patient) of unknown age and gender reported that he/she received dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: FC3180) via an unspecified route of administration on 23Aug2021 at about 10-10:30 in the morning as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date patient experienced side effect, including swelling inside mouth around neck and some facial swelling and little in my face but lips now particular. The event outcome was unknown for all events.  Consumer was informed about the role of Pfizer drug safety and asked to file the drug safety report   Consumer was unwilling to complete the report and provide the further information, Hence limited information available over the call.
Hormonal imbalance; Localised muscle weakness (Weak in knees and ankles); Fatigue; Fever; Fall; This spontaneous case was reported by a consumer and describes the occurrence of HORMONE LEVEL ABNORMAL (Hormonal imbalance), FALL (Fall), MUSCULAR WEAKNESS (Localised muscle weakness (Weak in knees and ankles)), FATIGUE (Fatigue) and PYREXIA (Fever) in a 41-year-old female 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.   On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. In 2021, the patient experienced FALL (Fall), FATIGUE (Fatigue) and PYREXIA (Fever). On an unknown date, the patient experienced HORMONE LEVEL ABNORMAL (Hormonal imbalance) and MUSCULAR WEAKNESS (Localised muscle weakness (Weak in knees and ankles)). In 2021, FATIGUE (Fatigue) and PYREXIA (Fever) had resolved. At the time of the report, HORMONE LEVEL ABNORMAL (Hormonal imbalance), FALL (Fall) and MUSCULAR WEAKNESS (Localised muscle weakness (Weak in knees and ankles)) outcome was unknown.            It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  No concomitant medication information was provided.  The reporter's causality for the event(s) of FELL DUE TO HORMONAL IMBALANCE MADE WEAK IN KNEES AND ANKLES unknown onset, FELL DUE TO HORMONAL IMBALANCE MADE WEAK IN KNEES AND ANKLES onset in 2021 and FELL DUE TO HORMONAL IMBALANCE MADE WEAK IN KNEES AND ANKLES unknown onset was not provided. The reporter's causality for the event(s) of FATIGUE WITH SECOND COVID VACCINE and FEVER WITH SECOND COVID VACCINE with HUMIRA(ADALIMUMAB) was no reasonable possibility.  No treatment medication information was 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.
8OCT91 TC from mom @ 230PM stated pt devel t 105 AX evening of 7OCT p/recvd 4th DTP c/o h/a & wouldn't walk on leg; area on back warm to touch;
Sleepiness; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of sleepiness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sleepiness (Verbatim: Sleepiness). The outcome of the sleepiness was not reported.   It was unknown if the reporter considered the sleepiness to be related to Shingrix.     It was unknown if the company considered the sleepiness to be related to Shingrix.   Additional Information: GSK Receipt Date: 18-OCT-2023 The patient had an awful reaction to this shot. Fever, chills vomiting and sleepiness for a full day. I hope we did not have to take it every year. Never had any reaction to the Covid shots and the only reaction to Shingrix was sleepiness, but the RSV killed me.
Fever 103.6,  Aches and pain throughout entire body Severe headache Nausea Fever at  highest 20 hours after vaccine  Fever levelled off to 100-101 and persisted for 2 days.
patient received RSV vaccine 10/6/2023 and started feeling dizzy with heart racing. went to ED. had testing completed and was treated and released with follow up.
vaccine administered 4/27/2022 , expiration date of 5/31/2022 but beyond use date was 4/18/2022
as I got into my car, I started sneezing. During drive, my lips started to go numb, and swelled a little. I arrived home less than a half hour later. My voice was hoarse and irritation at back of my nose and throat.  I went inside and took a double dose of children's liquid benedryl.  The rest of the day and evening very tired and lips still a bit irritated. Following morning (9/15/2020) I saw the normal bruising  at the injection site, but approximately 3 inches below, there is a huge welt. (Like I get after one of my allergy shots).  At approximately 10am, I started to sneeze again, lips went numb, an rapid onset explosive headache, left temple, and my vision reminded me of when I almost fainted many years ago. I drank another double dose of children's liquid benadryl, and within a few minutes, the symptoms subsided..except  the red welt on left upper arm is still there.
9 days after injection she developed a 3 inch wheel around the vaccination site. The arm was swelled and reddened  and the site itched
Vaccination site raised a size of a quarter above arm, red, area hard like bee sting, very sore, a little itchy.
Swelling & redness at local site, warm & erythematous indurated area Irregular of 1-3cm x 4cm with enlarging surrounding area of light erythema. Given Rx Acetaminophen for pain and recommended cold compresses for 4 days and if continues could apply warm compresses. If area of redness continues to increase was advised to fill Rx for Cephalexin antibiotics.
Covid-19; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59-year-old male patient received BNT162b2 (BNT162B2), on 01Oct2021 at 13:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 59 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown results. Therapeutic measures were taken as a result of covid-19, covid-19 included PAXLOVID from 18May2022 to 24May2022. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
pt recv vax 12MAR96 & rash on both thighs noted 13MAR96;fever on 14MAR96 102.4, to MD fever was 103;no noted illness or infect;father states can still see evidence of rash @ times;
Initial report received on 29 July 2009 from a health care professional. A cluster of two five year old patients with a history of speech delay and autism received DAPTACEL (lot number C3141AA) intramuscularly in the left thigh on 27 July 2009 in the morning. By that evening the children had significant knee swelling of the left leg which extended to the upper thigh. The children were unable to walk that night. The next morning they were both walking with a limp. They were seen by a physician who diagnosed them with Arthus reaction type 3, severe local inflammatory reaction. Recovery status was unknown. List of documents held by sender: none. The reporter of this case is the same as case number 2009-03234.
Fluzone High Dose flu vaccine to a patient who is 63 years old in error, no AE; Fluzone High Dose flu vaccine to a patient who is 63 years old in error, no AE; Initial information received on 03-Oct-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case involves a 63 years old patient who was vaccinated with a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] lot number not reported via unknown route in unknown administration site on an unknown date.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to overdose and Inappropriate age at vaccine administration.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.  List of documents held by sender: none.
Patient experienced numbness and tingling of tongue during observation period.  Denies any issues with throat or other symptoms.
Had fever in it; Her arm got a baseball sized red spot at the injection site; Felt like a wasp was stinging it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Had fever in it), VACCINATION SITE ERYTHEMA (Her arm got a baseball sized red spot at the injection site) and VACCINATION SITE PAIN (Felt like a wasp was stinging it) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Had fever in it), VACCINATION SITE ERYTHEMA (Her arm got a baseball sized red spot at the injection site) and VACCINATION SITE PAIN (Felt like a wasp was stinging it). At the time of the report, VACCINATION SITE WARMTH (Had fever in it), VACCINATION SITE ERYTHEMA (Her arm got a baseball sized red spot at the injection site) and VACCINATION SITE PAIN (Felt like a wasp was stinging it) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported by the reporter. No treatment information was provided by the reporter.
After asking for and confirming they wanted the flu shot, receiving receipt of flu vaccine, and receiving the flu shot, the patient was upset about receiving a flu shot instead of the covid vaccine.  We discussed the request and confirmation of flu shot, the receipt the patient received for the flu shot and the patient's discussion with the patient asking about previous flu shots.  She then requested the covid vaccine and it was administered to her.
Otherwise healthy 29y M developed severe generalized headache and fever to 104.8F lasting over 48h after third and fourth doses of oral typhoid vaccine by Vivotif Berna. However, also had cough, myalgias and sore throat during this time.
Patient developed all over body rash 4 days after receiving vaccine. She took a benadryl and called the pharmacy.
Following immunization infant experienced a fever of 105.5, also vomiting and screamed the entire evening. presented in ofc following morning w/fever of 101.4, No other symptoms.  Given tylenol.
Vial that expired on the 20Jan2022 were put in the freezer underwent excursion for 3 months; vial that expired on the 20Jan2022 were put in the freezer underwent excursion for 3 months; Patient received an expired vaccine for a booster dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine for a booster dose), PRODUCT STORAGE ERROR (Vial that expired on the 20Jan2022 were put in the freezer underwent excursion for 3 months) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial that expired on the 20Jan2022 were put in the freezer underwent excursion for 3 months) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045L21A) for COVID-19 vaccination.     Patient had no allergies and no history relating to mentioned AE both Acute and Chronic illnesses at the time of vaccination. No other vaccine given within 1 month prior to Moderna COVID-19 vaccine. It was unknown if patient ever had COVID test or diagnosis.  Previously administered products included for Product used for unknown indication: Janssen (Jansen for primary series). Past adverse reactions to the above products included No adverse event with Janssen.    On 27-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine for a booster dose). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial that expired on the 20Jan2022 were put in the freezer underwent excursion for 3 months) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial that expired on the 20Jan2022 were put in the freezer underwent excursion for 3 months). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received an expired vaccine for a booster dose), PRODUCT STORAGE ERROR (Vial that expired on the 20Jan2022 were put in the freezer underwent excursion for 3 months) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial that expired on the 20Jan2022 were put in the freezer underwent excursion for 3 months) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.  It was reported that patient did not seek any medical attention. It was reported that the vial which expired was initially stored in refrigerator on 20-Jan-2022 and later were put in the freezer and from 23-Feb-2022 until the 12-May-2022 it was administered to 13 patients, all booster dosages, after the expiry. It was also reported that the vials underwent maximum 44.6 degree F and minimum 38.8 degree F of temperature excursion for 3 months. No visual inspection noting any vaccine state change as vials were in seal boxes. Number of vials/doses impacted: 660 doses, and they have now 520.   This case was linked to MOD-2022-572778 (Patient Link).
This report from study was reported via Pregnancy Registry (initial receipt 20-Mar-2015) concerns a neonate patient. Concomitant medications, received via the mother in utero included a prenatal vitamin, calcium, iron for anemia and TUMS for heartburn. She had coffee (1/2 cup once weekly) from 12-Mar-2013 to 01-Sep-2013. The 32-year-old mother had no previous pregnancies and had a first trimester serum test on 04-Jun-2013, alpha-fetoprotein test on 02-Jul-2013, glucose tolerance test on 04-Sep-2013, and ultrasound tests on 11-Jun-2013, 23-Apr-2013 and 30-Jul-2013. The mother's DOC (date of conception) was 26-Mar-2013 and EDC (estimated date of confinement) was 17-Dec-2013. There was no family history of congenital anomaly including Marcus Gunn Syndrome. On the 22-Sep-2013, the patient received the Tdap vaccine (adult) via the mother intrauterine. On the 25-Sep-2013, the patient received the AFLURIA vaccine (batch number R53207) via the mother, intrauterine, 1 shot 1 day. On the 21-Dec-2013, the patient was born at a gestation age of 40.6 and the birth weight was 3.75 kg. The baby was diagnosed with left eye ptosis (jaw winking syndrome) as per the pediatric medical record and was being followed by a pediatric ophthalmologist. The baby was also diagnosed with hemangioma in the left chest under the nipple ranging in size from 2cm - 3x5 cm with 1x1 tail. At 12 months of age the hemangioma was 3cm per pediatric records. Outcome was unknown. Linked to case 2015049895 (mother's case).
extremely sick; her lungs and stomach started hurting; her lungs and stomach started hurting; asthma flare up; caller was not able to speak loudly due to trauma to her throat from all the health issues she had had; caller was not able to speak loudly due to trauma to her throat from all the health issues she had had; she reported having pain all over all the time due to the vaccine; still having daily migraines; problems with sciatica; GERD; This spontaneous report was received from a female patient of unknown age. The patient's concurrent conditions included asthma. Her medical history and concomitant medications were not reported.  On 17-AUG-2021, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) for prophylaxis (dose, route, lot# and expiration date were not reported).  Since she received the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine on that date, she had been extremely sick. Immediately after the vaccine was administered, she became extremely ill. Her lungs and stomach started hurting and that her asthma flared up. She was not able to speak loudly due to trauma to her throat from all the health issues she had had since the vaccine being administered. She also was having pain all over all the time due to the vaccine. She had to call an ambulance on 01-SEP-2021 (also reported as the last Wednesday) and was rush to the hospital. She was not admitted but was sent home on medication. Her primary physician though she was given the Coronavirus disease (COVlD) vaccine instead of the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine, however, she called the pharmacy were she got the vaccine and they reported that it was the pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) vaccine that she had received. She was no longer able to stay on the phone to provide more information due to be extremely sick. She reported it has been going on 3 weeks now. After that, on an unknown date in 2021, she experienced and still having daily migraines, problems with sciatica, gastroesophageal reflux disease (GERD), asthma, had not driven in a month and missing out on too much. Caller stated her daily life changed. She had doctor appointments that she had to cancel if no one was there to take her because she could not drive.  The outcome of illness, pain, speech sound disorder, oropharyngeal discomfort, asthma aggravated, abdominal pain upper and pulmonary pain was unknown. The outcome of migraine, gastrooesophageal reflux disease and sciatica was not resolved.  The reporter considered the pain to be related to Pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23). The causal assessment between all the other events and the suspect therapy was not provided.
Anaphylaxis Narrative:  1ST COVID 19 VACCINE PFIZER. 2 MINS AFTER DEVELOPED STRIDOR AND ANYPHYLAXIS. SHE DID NOT REPORT HISTORY OF ANYPHYLAXIS PRE-VACCINE HEALTH SCREENING. DURING EMERGENCY CARE REPORTED A HISTORY OF ANYPHYLASIS TO IV BENYDRYL. TRANSPORTED TO ER FOR FURTHER EVALUATION. EPINEPHRINE AUTOINJECTOR ADMINISTORED TWICE.
This spontaneous report was received from a registered nurse regarding an unspecified number of patients of unknown demographics. There was no information about concurrent condition and historical medication. On 13-SEP-2016, the patients were vaccinated with improperly stored VARIVAX lot # I048465/ expiration date- 02-DEC-2017. No adverse event was reported. No concomitant medication was reported. The outcome of the event was unknown. NO PQC (product quality complaint) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
pt states 1 hrs later started w/dull ache, deep sensation approx 3" long x 2" below inject site, no redness or swelling noted;
10 hours after the 2nd  injection I developed severe  chills for a couple of hours along with body aches. The body aches lasted 24 hours.
lt deltoid area sterile abscess which required  I&D, gauze packing & several subsequent visits to doctor;
12 hours after injection started with chills, aches and fever. Then dizziness started soon after. Fever and chills resolved in about 24 hours. Dizziness has gotten worse as the days progressed. 4 days out now and I?m still having significant dizziness that feels like vertigo.
Trouble breathing, coughing, wheezing, trouble swallowing, headache, red blotches by vaccine site
Mild injection site pain within a couple hours, moderate injection site pain and swollen lymph node next day - swollen lymph node was moderately to very painful, radiating from left armpit (injection was in left arm). Fatigue and lower than normal heart rate variability since vaccine.  Lymphoma has  80% resolved.