chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Moderna COVID-19 vaccine was administered to patients past the published expiry date; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) in a 98-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date). On 09-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered to patients past the published expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. No treatment information was provided.  The vials were stored in the freezer and taken out of the freezer and placed in the refrigerator on the date of administration. The vials did not undergo any temperature excursions
I experienced 2 heart attacked within 3 days of receiving my second PFIZER vaccine; This is a spontaneous report from a contactable consumer (patient).  A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took the first dose of  bnt162b2 on an unspecified date  (Batch/Lot number was not reported) for Covid-19 immunisation. It was reported that the patient needs to speak to someone around the covid vaccine. The purpose of this dialogue was that he would like an additional insight to side affects. He experienced 2 heart attacked within 3 days of receiving his second Pfizer vaccine. All his tests have come back normal as he is an extremely healthy 42yr old male that workouts 5 days per week and runs around 10-15 miles per week. Outcome of the event was unknown.  Information about batch/Lot number has been requested.
This case was reported by a healthcare professional (nurse) via Merck and described the occurrence of sore arm (injection site) in a subject of unspecified age and gender who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date in May 2010 the subject received 1st dose of CERVARIX (unknown). At an unspecified time after vaccination with CERVARIX, the subject experienced sore arm (injection site). The nurse reported a subject received a 1st dose of CERVARIX in May 2010 and developed a "sore arm that was not red". The sore arm was not specified as local or systemic reaction. At the time of reporting the outcome of the sore arm was unspecified. Follow up was received from the healthcare professional on 6 February 2014. The reporter stated that the subject was "one child that had an issue with CERVARIX." The reporter had no further information to provide at the time of reporting. Follow-up information was received on 19 February 2014 via nurse who reported "we do not use CERVARIX in our practice. Do no know who this refers to". The nurse did not provide any additional information.
Night sweats, frequent awakenings, severe left arm pain extending into the left axilla, with noted erythema to left upper delt region and ventral aspect of the left upper arm.  Subjective chills, temp of 99.0 on Tylenol in clinic, slight nausea and diarrhea, worsening cough.
This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 57-year-old female patient who received Shingrix for prophylaxis. The patient's past medical history included chickenpox. In September 2018, the patient received the 1st dose of Shingrix. In September 2018, immediately after receiving Shingrix, the patient experienced pain in arm, abdominal pain, diarrhea and vomiting. On an unknown date, the patient experienced headache, injection site itching, shingles and feeling bad. The patient was treated with topical steroid nos (Steroid Cream). On an unknown date, the outcome of the pain in arm, abdominal pain, diarrhea, vomiting, headache, injection site itching, shingles and feeling bad were unknown. It was unknown if the reporter considered the pain in arm, abdominal pain, diarrhea, vomiting, headache, injection site itching, shingles and feeling bad to be related to Shingrix. Additional details were reported as follows: The age at vaccination was not reported. The patient had the previously recommended Shingles shot about 3 years before the time of reporting. In 2018, 3 weeks before the time of reporting the patient received a dose of Shingrix. After vaccination the patient experienced terribly sore arm and it was lasted for 3 to 4 days. About 1 week later, the patient experienced severe abdominal pain with diarrhea and throwing up. Again 1 week later, the patient had headache and as per the patient it was worst headache in his life. The patient's head was hurt so badly and the patient started to throwing up and continued to did so for 24 hours along with raging diarrhea. The patient was in bed for next 2 days and felt bad at least for more 4 days. The patient was kept trying to figure out what was wrong with him. The patient also experienced itching at the injection site that was maddening. The patient was called to his physician's office told them he thought he was had a shingles outbreak at the injection site. The nurse told him to come in to the physician office and it was confirmed. The patient was understand the sore arm and all other events, but to actually get a case of shingles was outrageous to the patient. The patient was asked, did this mean he would now had shingles or at least the possibility of another outbreak,  The patient wanted to know for the rest of my life would the outbreak he had spread to other parts of his body. The patient's physician advised him to did not get the 2nd dose of vaccination. The patient was very upset. The patient very careful about personal exposure to anything contagious. The patient requested to email him back with the answers to his questions. The physician could only gave him a topical steroid cream and a pill to lessen the itch but itch was not stopped. The patient look forward to hearing back.
Patient stated that when she awoke the next morning she could not feel her feet, by end of the day it was up her calves and in her hands. By Friday the numbness and tingling was only in her hands and feet. But it is improving.
It hurt; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer and lymph node excision (lymph nodes removed due to breast cancer).   On 21st October 2019, the patient received the 1st dose of Shingrix. On 21st October 2019, immediately after receiving Shingrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left deltoid and stated it hurt. The patient was due for the 2nd dose which she did not wanted in her left arm and was unable to receive in her right arm due to history of lymph nodes removed due to breast cancer. The patient would like to receive the 2nd dose at an alternative site. The reporter consented to follow up.
On 10th day after vacine, arm is swollen (3 inch square area) hot and aching. Noticed it about 11:00 this morning
This spontaneous report was received from a certified medical assistant and refers to an unknown number of patients (age and gender were not reported). Pertinent medical history and drug allergies or drug reactions were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of VAQTA (lot number, expiration date, dose and route of administration were not reported). Concomitant medication was not reported. No adverse effects were reported. It was unknown if the patients sought medical attention. This is one of three patients from the same reporter. Additional information has been requested.
PATIENT EXPERIENCED UPSET STOMACH WHICH IS A NORMAL SIDE EFFECT OF THIS VACCINE. PATIENT WENT TO URGENT CARE ON 12/15/19 WAS PRESCRIBED AN ANTIBOTIC AND STERIOID CREAM.
6 hours of uncontrollable crying started at 6:30 pm, two hours after receiving vaccinations and lasted until 11:30 pm, reported by mother.
Info has been received from a physician concerning an 8 year old male who, at 12 months of age", in approximately 1998 was vaccinated with a dose of varicella virus vaccine live. "Three weeks ago", in March 2005, the pt was diagnosed with chickenpox and had greater than 100 vesicles. It was reported that the pt was ordered to take an antiviral, "VEREX", for 5 days. Unspecified medical attention was sought. No product quality complaint was involved. Additional info has been requested.
This spontaneous report as received from a nurse practitioner concerning a 30 years old female patient with cephalexin and codeine allergy and codeine allergy who was vaccinated SQ with a first dose of (Merck) VARIVAX (lot # 673078/0261AE) (dose not reported) on 19-JUN-2012. No other co-suspects were reported. No concomitant medications were reported. The nurse practitioner stated that on 23-JUN-2012, the patient experienced localized area reaction in right deltoid approximately 3 inches in diameter "big and red", which lasted two approximately two weeks approximately on 07-JUL-2012. There was not treatment given for the event. There were no labs performed. The outcome of localized area reaction in reaction in right deltoid approximately 3 inches in diameter "big and red" was reported as recovering/resolving. The relatedness for localized area reaction in right deltoid approximately 3 inches in diameter "big and red" was unknown for (Merck) VARIVAX. Additional information has been requested.
Flu Shot was given in Employee Health to the L shoulder. I looked away as it was given. Afterwards, 30 minutes afterwards my arm was feeling stiff with my range of motion decreased from stiffness. Also having pain when trying to use my range of motion. Shot was noted to be given in the front portion of the upper shoulder. I shared with my employee my worries as it appears to be there anterior portion, I shared with my employees my concerns. I was told to wait and see if this continues as some soreness is known. Soreness and pain with stiffness continue for next 2 days and by 4th day stiffness began wearing off slowly, but soreness kept lingering with a feeling as if the shoulder is weaker and is mild pain with range of motion with intermittent pain. Pain still present week afterwards with range of motion pain as well. Week afterwards = soreness with mild pain present upon pressure to insertion site with bruised area. Employee health notified and told to fill out Employee incident report.
No Adverse Event; Moderna Covid-19 monovalent were administered BUD; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) in a 6-month-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Feb-2023, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 monovalent were administered BUD).    No concomitant medications were reported.  No treatment medications were reported.  This case contains information for the 11th of 15 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-713271 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-Feb-2023: Live follow-up document received includes patient demographics (initial and DOB), vaccine administration date were updated. On 28-Feb-2023: Follow-up document received includes no new information. On 28-Feb-2023: Follow-up document received includes reporter details were updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713271:Patient 1
REALLY SICK; DIARRHEA; SUSPECTED COVID-19; HEMORRHOID PROBLEM; BOWEL MOVEMENTS ARE MORE FIRM; This spontaneous report received from a patient concerned a 62 year old female. The patient's weight was 103.2 kilograms, and height was not reported. The patient's concurrent conditions included secondary pulmonary hypertension, diarrhea, and change in her bowel movements. The patient received covid-19 vaccine  (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch number in this case. Non-company suspect drugs included: macitentan (oral, batch number: ZE019B0101 expiry: 31-JUL-2024, form of admin was not reported) 10 mg, 1 time every 1 day, therapy dates were not reported for an unspecified indication; and epoprostenol sodium (intravenous, batch number: MM254M0101 expiry: 31-JUL-2022, form of admin was not reported) 1.5 mg, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On 2021, the subject experienced suspected covid-19. On 2021, the subject experienced hemorrhoid problem. On 2021, the subject experienced bowel movements are more firm. On 2021, the subject experienced diarrhea. On 26-APR-2021, the subject experienced really sick. The action taken with covid-19 vaccine  was not applicable; and dose of macitentan, and epoprostenol sodium was not changed. The patient recovered from really sick on 28-APR-2021, and the outcome of suspected covid-19, diarrhea, bowel movements are more firm and hemorrhoid problem was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comments not required as per standard procedure as the case is assessed non serious.
Felt hot. Funny in my head and chest. Felt like could pass out approximately10-15 min after shot. I went back to the clinic. No treatment needed. I still dont feel quite right at 7 hours post injection
This spontaneous report as received from a healthcare professional refers to a patient of unknown demography. On an unknown date, the patient was vaccinated with GARDASIL 9. On an unknown date, the patient experienced unspecified adverse reaction. The outcome of adverse reaction was unknown. The reporter did not provide the causality between the events and the suspect therapy. Additional information is not expected as the reporter does not want to be contacted.
I a having severe headache that is not resolving by taking medication; The pain is gradually hitting my left eye like stabbing pain; Neck and shoulder pain; Neck and shoulder pain; Nausea; Loss of appetite; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 39 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 24Aug2021 07:30 (Lot number: Ewp187) at the age of 39 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (unspecified if ongoing); "Arthritis" (unspecified if ongoing); "ADHD" (unspecified if ongoing); "RA positive" (unspecified if ongoing). Concomitant medication(s) included: CONCERTA; SENNA LAXATIVE. The following information was reported: HEADACHE (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "I a having severe headache that is not resolving by taking medication"; EYE PAIN (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "The pain is gradually hitting my left eye like stabbing pain"; NECK PAIN (non-serious), ARTHRALGIA (non-serious) all with onset 25Aug2021 09:00, outcome "not recovered" and all described as "Neck and shoulder pain"; NAUSEA (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Nausea"; DECREASED APPETITE (non-serious) with onset 25Aug2021 09:00, outcome "not recovered", described as "Loss of appetite". Therapeutic measures were taken as a result of headache, eye pain, neck pain, arthralgia, nausea, decreased appetite.  Additional Information: The patient receive medications within 2 weeks of vaccination are Concerta and senna laxative. Patient received treatment of ibuprofen 800 mg. Patient didn't had known allergies. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination.  No follow-up attempts are possible. No further information is expected.
Chest Pains; Extreme cough and congestion; Extreme cough and congestion; Hard to breath; Fatigue and Weak; Fatigue and Weak; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Sep2021 15:00 (Lot number: FE5180) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FD8448, Location of injection: Arm Left, Vaccine Administration Time: 03:30 PM), administration date: 13Aug2021, when the patient was 16 years old, for COVID-19 Immunization.  The following information was reported: CHEST PAIN (non-serious) with onset 03Sep2021 19:00, outcome "not recovered", described as "Chest Pains"; COUGH (non-serious), NASAL CONGESTION (non-serious) all with onset 03Sep2021 19:00, outcome "not recovered" and all described as "Extreme cough and congestion"; DYSPNOEA (non-serious) with onset 03Sep2021 19:00, outcome "not recovered", described as "Hard to breath"; FATIGUE (non-serious), ASTHENIA (non-serious) all with onset 03Sep2021 19:00, outcome "not recovered" and all described as "Fatigue and Weak". The events "chest pains", "extreme cough and congestion", "extreme cough and congestion", "hard to breath", "fatigue and weak" and "fatigue and weak" were evaluated at the physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of chest pain, cough, nasal congestion, dyspnoea, fatigue, asthenia.  Additional information: The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient had not received any other medications within 2 weeks of vaccination. Since vaccination, the patient tested for COVID-19. The patient has no known allergies.
Information has been received from a licensed practitioner nurse referring to a 11 year old patient. On 18-FEB-2016, the patient was vaccinated with PEDVAXHIB (lot # J013944, expiration date 13-AUG-2016, dose, route not provided) (inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information has been requested.
About 3 days after my second dose I received on April 14th, 2021, on April 17th, 2021 at around 11 PM I noticed hives in between my toes, as well as hives going up the arches of each foot and along the outer sides of each foot, as well. They were bright red, and slightly itchy. I put a topical Benadryl on the reaction, however, they have yet to go away, but they have darkened slightly in color and have gotten more itchy as time has passed.
She had the vaccine on 6/21 & began itching that day. She developed rash & cough & hoarseness & then developed hives. She was taking BENADRYL 75 mg q 5hrs without benefit. She presented to my office on 6/23 & still had hives on her thighs so she was given ARISTOCORT 40mg IM.
This spontaneous report as received from a healthcare student refers to unspecified number of female patients of unknown ages. The patients pertinent medical history was unspecified. On an unknown date unspecified number of patients were vaccinated with M-M-R II. The concomitant medications were unspecified. The unspecified number of patients received M-M-R II on unspecified dates approximately 3 years before becoming pregnant and had no immunity to measles, mumps or rubella during pregnancy. It was reported that the lab diagnostic tests conducted were unspecified. The outcome of no immunity to measles, mumps or rubella during pregnancy was unknown. The causality was not reported. Additional information has been requested.
ErythemaMultiform, UrticariaPruritus, Injection site pain Narrative:
Macular/ Papular/Pusular rash over head/trunk/extremities.
2nd Moderna COVID-19 Vaccine given 23 days after 1st. No adverse reaction noted.
Information has been received from a licensed practical nurse referring to unspecified patients of unknown age and gender. On unspecified dates, the patients were vaccinated with GARDASIL which had been exposed to temperatures outside of the recommended range, (lot # K006960, expiry date 19-FEB-2017), (route, dose and frequency not reported). No adverse effect had been reported. This is one of several reports received from the same reporter. Additional information has been requested.
Mom states baby awoke fr nap w/jitteriness temp 101(r), baby displayed jitteriness & drowsiness some difficulty in arousing him;