chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence if pain in arm in a adult female patient who received SHINGRIX. On an unknown date, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a day after receiving SHINGRIX, the patient experienced pain in arm, fever, headache, injection site erythema and injection site swelling. The patient was treated with analgesics, nos (pain medication). On an unknown date, the outcome of the pain in arm, fever, injection site erythema and injection site swelling were recovered/resolved and the outcome of the headache was unknown. It was unknown if the reporter considered the pain in arm, fever, headache, injection site erythema and injection site swelling to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in an unknown arm (not specified). The specific dosing was not provided. The site and other details for vaccines administration were unknown. In the evening of vaccination, the patient's arm became sore and the patient had a mild headache. Later, the patient woke up at 12:30 AM (1 day after vaccination), feeling feverish and headache and arm pain were severe. The patient took OTC (over the counter) pain medicine and then slept through the night. In the morning, the nurse described that the fever was gone in that the patient denied feeling feverish and her arm was still very sore and there was now at the injection spot a small red or pink-colored circle with a bit of swelling. It was like that for a few days and then it faded it away. At the time of reporting, the arm was fine and back to normal. The fever was gone. The status of the headache was unknown. The nurse discussed the adverse event profile with medical science liaison (MSL) and seemed to indicate that the symptoms were consistent with the labeling, though she did not specifically say that SHINGRIX caused the symptoms. The nurse said the patient was planning to get a second SHINGRIX dose in the future. It was reported that it was okay to contact the reporter but the MSL did not have any phone number for her office. The nurse did not provide further related details.
Data exchange not properly working in EHR office procedure did not include immunization reconciliation - causing extra dose to be given.
This spontaneous report as received from a healthcare worker refers to a 19 year old patient of unknown gender. On 14-AUG-2015, the patient was vaccinated with a dose of improperly stored GARDASIL (Lot # L010596, expiration date: 06-APR-2017) (strength, dose and route were not provided) and on 20-OCT-2015, with a dose of improperly stored GARDASIL 9 (lot number L000610, expiration date: 31-JAN-2017) (strength, dose and route were not provided). NO adverse effects reported. This is one of several reports from the same source. Additional information has been requested.
Expired Engerix B administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received HBV (Engerix B) (batch number LM992, expiry date 13th December 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 19th December 2022, the patient received the 2nd dose of Engerix B and Engerix B Pre-Filled Syringe Device. On 19th December 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-DEC-2022. Reporter's Comment:  The reporter stated that a patient received the second dose of Engerix-B, which expired on 13th December 2022, on 19th December 2022. This took place at the same site from which the reporter was calling.  Information for the adverse event was collected. Reporter asked to be contacted through e-mail only. The Vaccine Administration Facility was the same as Primary Reporter. Additional supportive Information: The patient received the second dose of Engerix-B, which expired on 13th December 2022, which led to expired vaccine used.
Itching to face and legs. Rash to left leg. States she applied Hydrocortisone cream to areas. Side effects have improved.
102-103 Fever, chills, flu like symptoms, and 36 hours later was better.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 10-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Vaccine was administered after 15 days of first puncture of vial. No concomitant medication information was provided. No treatment medication were provided.  Company Comment: This is a case of expired product administered for this 74-year-old patient, unknown gender, with no medical history reported, with no associated adverse event reported at this time. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.   This case was linked to MOD-2021-337432 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow-up information includes no new information , but the dose number updated to 2 and therapy onset updated and .relevant information added in inarrative.; Sender's Comments: This is a case of expired product administered for this 74-year-old patient, unknown gender, with no medical history reported, with no associated adverse event reported at this time. The rechallenge is not applicable. Patient received both doses expired. The benefit-risk relationship of Moderna COVID-19 Vaccine  is not affected by this report.
Diarrhea 7X's a day for 1 to 2 weeks, fever-103.5 at onset, decrease in appetite, fussiness.
moderate stomach pain, night of  March 15, then by March 18 Emergency visit for severa stomach pain.   Tenderness increasing on right side of waist.    Incorrectly diagnosed as UTI.  Next visit on Sunday,  March 21, diagnosed with shingles.
On January 17, 2022, the day following my second dose of the Moderna Covid19 vaccine, I noticed a small area of unusual but mild pain in the skin  just to the right of my lower sternum. No rash or other change to the skin was visible. The following day I observed an area of rash with raised red bumps in the same area where the pain had occurred. The area of rash covered about 3/4 inch high by 1-1/2 inches long,  and did not spread after I first observed it. The rash itself was not painful or itchy, but was accompanied by a band of pain just under the skin that extended to the right from the area of the rash in a narrow horizontal band about six inches long and reaching to the right side of my torso. I would describe the pain as tenderness over the ribs, similar to a serious bruise, but without any injury to account for it.   By the second day after the rash appeared, the raised spots had developed into small fluid-filled blisters, and by about January 25, the blisters had burst and begun to dry. At the time of this writing the rash is still visible and the pain remains but has diminished.
Pt had reaction to 1st dose of COVID vaccine. Advised to be seen by allergist before getting 2nd dose. Pt consulted with allergist before 2nd dose and was cleared to receive dose while taking high doses of antihistime. Rec'd 2nd dose on 3/26/21. Reports that in the morning of 3/27/21, she had a "headache, rash on the back or her head/base of neck, buttocks, and stomach, as well as nausea and achy joints". States she followed the allergists recommendations and pre-medicated with the high dose antihistimine before injection, as well as after. States s/s resolved after 3 days. Did not seek medical care, just followed allergist recommendation.
Flu vaccine was administered with 5/8 inch needle instead of 1 inch needle.
developed fevers and chills for 3 days after the 2nd shot. Since then has been experiencing severe fatigue, myalgias, muscle weakness, and chills for nearly 2 months. Labs show elevated sed rate and equivicoal  Lyme test. ANA, RF, CMP, CPK all normal. Working diagnosis right now is atypical PMR/TA vs. Lyme vs. immune response to vaccine.
Dose was given after beyond use date, but before expiration date. spoke with patient on 12/29/22.
Bottom lip swelling and tingling and left side of tongue tingling, lt side of body weakness and tingling a few minutes after receiving anthrax vaccine. Initially started in rt arm then migrated to lt within minutes of receiving immunization.
From 3/11/2021 until 3/29/2021 the patient was  in the hospital due to lack of appetite and kidney failure.  The doctor certifies that the cause was more natural
This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness), TREMOR (Shaky) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Dec-2021, the patient experienced TREMOR (Shaky) and CHILLS (Chills). On an unknown date, the patient experienced PAIN (Soreness). At the time of the report, PAIN (Soreness), TREMOR (Shaky) and CHILLS (Chills) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided.
Bad smell in nose, especially with hot things/  Smell is very acrid and sharp - like something burnt; Also affects taste to some extent; This is a spontaneous report from a non-contactable consumer, the patient. A 50-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the left arm on 15Apr2021 at 12:30 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient received unspecified medication within two weeks of vaccination. The patient previously received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, lot number: EN6204) in the right arm on 18Mar2021 at 12:15 (at the age of 50-years-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient had no known allergies to medications, food or other products. The clinical course was reported as follows: on 19Mar2021, the patient experienced primarily bad smell in nose, especially with hot things, also affected taste to some extent, but primarily smell. Smell was very acrid and sharp - like something burnt. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event primarily bad smell in nose, especially with hot things, smell is very acrid and sharp - like something burnt and also affects taste to some extent was not recovered at the time of this report.   No follow-up attempts are possible. No further information is expected.
Patient received flu shot on Wednesday, 10/30/19. On 12/2/19, patient was admitted to emergency room with incontinence, feeling poorly, and being unable to care for self.  Patient was later admitted to nursing home for continued care.  On 12/5, patient was admitted to hospice/end of life care due to his heart block, Hodgkin's lymphoma, as well as his untreated AAA. Patient's daughter requested we submit an adverse event report due to the timing of the immunization and decline in health.
Typical flue symptoms: fever, headache, sweat, shiver, a few phlegms, muscular pains (located in particular in the left arm where the vaccine was injected). This lasted for 36 to 48 hours.
Given Hepatitis B Injection at 0755 and at 1030 is reporting a stomach ache, lightheadedness, and nausea.  No vomiting. Currently at work and employer is to return this patient back to the clinic if patient so desires for treatment thus far the patient has not returned for treatment.
Violent shaking and a 103 degree fever.  The violent shaking made me think I was having a seizure.  Nothing would stop the shaking.  It stopped on its own between 2:30 and 3 am. The following day I felt like I was hit by a truck and had body aches.
Those of us who have had the vaccines know about a sore arm and fatigue, but his is worse.; Those of us who have had the vaccines know about a sore arm and fatigue, but his is worse.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "blood cancer" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), FATIGUE (non-serious), outcome "unknown" and all described as "Those of us who have had the vaccines know about a sore arm and fatigue, but his is worse.". Additional information: Reporter's friend has blood cancer and had 4th dose (booster for immunocompromised) of the PBCV on Monday, 14Feb2022, following "an infusion of some kind on Friday, 11Feb2022. Since receiving the booster dose, he was extremely fatigued, had a very sore arm at the injection site and and "he was so weak his wife had to pick him up and put him into bed" Is this part of the normal side effects. Have you had other reports of immunocompromised patients having these symptoms. Should they be seeking out other treatment or is this normal. Those of us who have had the vaccines know about a sore arm and fatigue, but his was worse.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Staff member was receiving her booster of Pfizer after receiving Janssen COVID19 vaccination 05/27/2021.  Was observed by nursing staff x 15 minutes with no issues and was dismissed to home from work. About 1 hour post vaccination, staff member called their supervisor to report hives over their face, no problems breathing or swelling of lips or tongue.  Staff member was told to report to urgent care, who then told the staff member to report to the emergency room.  At the emergency room the staff member was given Benadryl and steroids, the hives resolved.  No further issues reported.  Staff member never reported swelling of the face, lips, tongue or problems breathing.
36 hours post-injection developed profuse papular rash with erythema and itching over bil arms, legs, abdomen. Trunk/back/face/chest/palms were not involved. Pt was admin. BENADRYL PO, hydrocortisone topic al cream.
Onset 7JUNPM w/t103, chills, c/o frontal h/a, tenderness @ site of inject-no swelling or redness on 7JUN94; On 8JUN94 seen in office w/swollen & redness @ site of inject & sl fever;
No other AE/PQC reported; temperature excursion on ROTATEQ/the product had been administered; This spontaneous report was received from an office manger and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 16-JUN-2021, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1684151 has been verified to be a valid lot number, expiration date 23-JUN-2021 (formulation, strength, dose, frequency and route of administration were not reported) for prophylaxis. There was no adverse event reported.   On 16-JUN-2021, the temperature excursion was 47.8 degrees Fahrenheit for a 5 minutes. Data logger was involved. There were no previous excursions.; Sender's Comments:  US-009507513-2106USA007324:
Initial report was received from a health care professional on 29 March 2012. A two-month-old patient had received an intramuscular dose one injection of PENTACEL (lot number, site and date not reported) and the next night (36 hours later) had an episode of apnea. No further information was available at the time of the report. The patient's outcome was recovered. Documents held by sender: None.
COVID-19; COVID-19; Moderate head and chest congestion; Moderate head and chest congestion; dry cough; core body aches to present; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61-year-old male patient received BNT162b2 (BNT162B2), on 22Mar2021 at 16:00 as dose 1, single (Lot number: ER8729), in left arm, on 12Apr2021 at 16:00 as dose 2, single (Lot number: ER8729), in left arm and on 01Dec2021 at 13:00 as dose 3 (booster), single (Lot number: FJ1620) at the age of 60 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Gout" (unspecified if ongoing); "Depression" (unspecified if ongoing); "ADHD" (unspecified if ongoing), notes: adult ADHD. Concomitant medication(s) included: LISINOPRIL, start date: 10Feb2020; FEBUXOSTAT, start date: 15Jan2016; DULOXETINE, start date: 01Jun2016; VYVANSE, start date: 01Jun2016. Past drug history included: Allopurinol, reaction(s): "Known allergies: Allopurinol". The following information was reported: VACCINATION FAILURE (medically significant) with onset 29Apr2022 at 19:00, outcome "not recovered", COVID-19 (medically significant) with onset 29Apr2022 at 19:00, outcome "not recovered" and all described as "COVID-19"; LOWER RESPIRATORY TRACT CONGESTION (non-serious), CEREBRAL CONGESTION (non-serious) all with onset 29Apr2022 at 19:00, outcome "not recovered" and all described as "Moderate head and chest congestion"; PAIN (non-serious) with onset 29Apr2022 at 19:00, outcome "not recovered", described as "core body aches to present"; COUGH (non-serious) with onset 29Apr2022 at 19:00, outcome "not recovered", described as "dry cough". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 antibody test: (20Apr2022) Positive; (27Apr2022) Negative; (30Apr2022) Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19. Therapeutic measures were not taken as a result of lower respiratory tract congestion, cerebral congestion, cough, pain.  Clinical course: Patient received Paxlovid for the treatment of COVID-19 from 20Apr2022 to 25Apr2022 and also received other medication in 2 weeks.
TINGLING IN ARM, DIFFICULTY BREATHING. PT HAD TAKEN BENADRYL BEFORE IN RESPONSE TO A GRASS ALLERGY. ADMINISTERED EPIPEN TO PATIENT ONCE SHE WAS HAVING BREATHING DIFFICULTIES.  THIS WAS NOT THE PT FIRST TIME HAVING ALLERGIC REACTION OR USING EPIPEN. AFTER EPIPEN ADMINISTRATION BLOOD PRESSURE AND PULSE WERE TAKEN AND WERE WITHIN NORMAL RANGE. EMS WAS CONTACTED AND ON SITE WITHIN 25 MINUTES. PT WAS NOT ADMITTED TO HOSPITAL BUT WAS SEEN BY A PHYSICIAN.  ACCORDING TO PT, DR ADMINISTERED DIPHENYRAMINE AND A STEROID.  PT WAS CONTACTED ON 10/2 AND SHE WAS AT HOME.
3.5 x 3.5 cm indurated area rt lateral thigh; onset four days p/immun;
Information has been received from health professionals concerning a 7 month old male who received his first dose on 17-APR-2007, second dose 20-JUN-2007, and a third dose, 2 ml oral 21-AUG-2007, of Rotateq (lot #655866/1110F; 56385/0030U; 656381/0875U respectively). Concomitant vaccines included Hib conj vaccine (lot#'s53523/0063U and 654679/1126F respectively), PREVNAR (lot #'s B08691F; B08690H; and B58845F respectively), and PEDIARIX (lot #'s AC21B096A; AC21B114CA; and AC21B124AA respectively). On 11-SEP-2007, the patient's mother phoned the office reporting that the patient had developed a fever, loose stools, was gassy, and was screaming every 1 1/2 hours at night. He was seen in the office and stool samples on 12-SEP-2007 were negative for Rota virus. The reporter stated that he continued to experience symptoms "on and off over the next couple of weeks." He was seen in the office again on 04-OCT-2007, after developing loose stools with mucous and low grade fever "on and off". On 05-OCT-2007, he was hospitalized and underwent an x-ray with barium enema "which cleared the intussusception". He was seen in the office in follow up to his hospitalization and reportedly was "doing fine". The reporter stated "the admission to the hospital and enema administration was intervention to prevent serious criteria". No product quality complaint was reported. The patients experiences were considered to be other important medical events by the reporter. This is one of two reports from the same source. Additional information has been requested.  10/23/07 Patient demographics provided by CDC. 10/23/07 Recieved contrast enema report from CDC which reveals patient had ileocolic IS at hepatic flexure & was successfully reduced. 10/23/07 Received vax record from pcp & VAERS database updated w/same.  12/4/07 Received ER medical records which reveal patient experienced irritability, fever & distended abdomen.  BE reduced IS but transferred to higher level of care for continued observation. FINAL ER DX: Intussusception.  Records faxed to CDC. 12/7/07 Reviewed hospital medical records which reveal patient experienced abdominal discomfort for approx 1 month starting w/ulcerations in mouth & throat & progressed to nightly abdominal pain, large amounts of gas, low grade fever intermittently.  PCP tested for rotavirus which was neg.  Initially had increased WBC.  GI consult done as outpatient 1 week prior to admit who dx GERD, tx w/antacid & antibiotic.  Transferred from outlying ER s/p BE revealed IS.  Admitted 10/6 & d/c same day.  To f/u w/PCP & have GI small bowel series done as outpatient.  FINAL DX: abdominal pain, possible formula intolerance, unlikely intussusception.  Records faxed to CDC.
Patient let us know in advance that patient always faints when getting vaccines or blood drawn. Immediately after vaccine, patient felt faint, and mother got her to floor. She immediately regained consciousness and was talking but wanted to remain laying on floor. After 20 minutes, she sat for another 35 minutes and was then ok to leave. I took her out in wheelchair in case of fall risk or fainting.
Injection site pain and red itchy rash developed after 24 hours that lasted 4 days. Headache and joint pain started 15 hours after receiving injection and headache lasted 48 hours. Joint pain started same time as headache and lasted 48 hours. Chills and hot flash  started 15 hours after receiving injection lasted 24 hours.
2 days post vaccination, developed horrible vertigo and bodyaches as expected. However, that night my neck exploded in a horrible rash that has continued to spread over my body for 5 days now. I have applied various topical steroids and antihistamines, received an IM injection of steroids from Urgent Care, and have been on prednisone for 3 days. It is still spreading, not getting better, and is horrifically itchy and painful.
The Moderna vaccine with lot # 003C21A that was sent out on 11/24/21 to our clinic should have the absolute expiration date of 12/17/21 and not 12/24/2021