chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatigue; Headache; Muscle Pain; Joint Pain; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038k20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes (Patient is under medication). Concomitant products included INSULIN for Diabetes, GABAPENTIN for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache), MYALGIA (Muscle Pain), ARTHRALGIA (Joint Pain) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient was not taking any medications to treat those side effects.
Red welt left side. > MOTRIN, ice (if got worse, to go to Urgent Care).
Died three days after vaccine; 13 year old boy dies three days after the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Died three days after vaccine) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old boy dies three days after the Moderna vaccine). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old boy dies three days after the Moderna vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product was not provided by the reporter. Treatment information was unknown.  Company comment: This is a case of death in a 13-year-old male subject with unknown medical history, who died one day after receiving the vaccine. Very limited information has been provided at this time. Further information has been requested.; Sender's Comments: This is a case of death in a 13-year-old male subject with unknown medical history, who died one day after receiving the vaccine. Very limited information has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
This spontaneous report as received from a licensed practice nurse refers to a 4 year old patient. On 13-JUN-2014 the patient was vaccinated with a dose of improperly stored MMR II (lot # J007929, EXP date 28-JUN-2015) and a dose of (Oka/Merck) VARIVAX (lot# reported as H015224, EXP date 10-AUG-2014). It was unknown if the patient sought medical attention. There was no adverse event reported. At the time of report, the status of patient was unknown. This is one of the several reports from the same reporter. Additional information has been requested.
This is a spontaneous report from a contactable physician and nurse via a Company representative. This physician and nurse reported for three patients, this is the 1st of 3 reports received for a male patient. A male patient of an unspecified age and ethnicity received TRUMENBA, via an unspecified route of administration at 0.5ml single on an unspecified date for immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced reaction to TRUMENBA (vaccination complication) on an unspecified date with outcome of unknown. The Pfizer Sales Representative mentioned that in the doctor's opinion the reaction was due to TRUMENBA.
Swelling under the left side of left breast; Mild headache; minor muscle pain in left and arms below elbow on top of arm; minor soreness at injection site; This is a spontaneous report from a contactable healthcare professional (patient).  A 68-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL-1283 (also reported as "FL-1283"), intramuscular on left arm on 19Jan2021 12:30 at a single dose for COVID-19 immunization. Medical history included known allergies to penicillin and dust molds. The patient is not pregnant at the time of vaccination.  No other vaccine in four weeks. Concomitant medications included Atorvastatin, ergocalciferol (VIT D), Biotin and Glucosamine with MSM. The patient previously took first dose of BNT162B2 (lot number: EK92316) on 29Dec2020 12:45 intramuscular on left arm for COVID-19 immunization. On 19Jan2021 at 16:45, the patient had swelling under the left side of left breast, mild headache, minor muscle pain in left and arms below elbow on top of arm and minor soreness at injection site. Patient was most concerned about swelling. No treatment for the events. The patient had no COVID prior vaccination and not COVID tested post vaccination. The outcome of the events was not recovered.
Information has been received from a physician concerning a female patient in her 80's who on 15-JAN-2008 was vaccinated with a dose of ZOSTAVAX (Merck) (route and lot # unknown). The physician reported that the patient experienced Guillain-Barre after receiving ZOSTAVAX (Merck). The patient was seen in the physician's office on 11-MAR-2008 for routine follow up. The physician also reported that the patient said she "had been in the hospital and "rehabilitation" between those visits for Guillain-Barre". At the time of the report the patient recovered on an unspecified date. Additional information has been requested.
6 years old received a boostrix vaccine; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-year-old patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Boostrix and Boostrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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: 1-Nov-2022 Reporter' comment: The reporter consented to follow-up. The case was linked with case US2022158125 reported by same reporter. Additional supportive information: The patient received Boostrix vaccine at inappropriate age, which led to inappropriate age at vaccine administration.; Sender's Comments:  US-GSK-US2022158125:same reporter
Left armpit lymph and arm swollen on day 3-4, then days 5-present most of left thigh cellulose/subcutaneous very sensitive and lightly painful to walk around/clothing rubbing or other thigh rubbing on it.     It's how I would imagine shingles feels just before rashy outbreak.
Patient reports that their face swelled on same side as injection site from ear to lower jaw. Lasted only 2-3 hours.
woke up with slight sore throat and had congestion for 8 days. Slight symptoms no fever or other symptoms
I had anxiety, headache, muscle aches, fever, dizziness, nautious, shaking really bad and my eyes were hurting and burning really bad.
UNKNOWN COVID-19 vaccine was administered within the community on the same day patient expired.  Family might have this information.  Was not shared with us.
received a dose from a vial that was expired/vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired/vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired/vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature). On 22-Jun-2021, EXPIRED PRODUCT ADMINISTERED (received a dose from a vial that was expired/vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD21-114680 (Patient Link).
Approximately 9 hours after I got the second dose of Moderna, I woke up and didn't feel well. I ended up fainting due to low blood pressure. I was taken to the ER and given an IV. Then a few days later, I felt unsteadiness/lightheadedness for approximately two weeks. Then that subsided and then I was experiencing shortness of breath for one to two weeks. Ever since the second dose of the vaccine, I've felt off.
ActHIB diluent was administered without the Hib lyophilized powder/ No AE; Initial information received on 27-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp (office staff).  This case involves a male patient of an unknown age who received 0.5 mL dose of ActHIB diluent without the Hib lyophilized powder (Product preparation error) of vaccine HIB (PRP/T) VACCINE [ACT-HIB] lot UJ112AAC, expiry date- 21-06-2020 via unknown route in unknown administration site on 26-Aug-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to Product preparation error.  At the time of report 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.  Documents held by sender: none.
shortness of breath; throat tightness; HR 133/HR 137; diarrhea; hives around injection site; Hives around i njection site and on contralateral arm and chest; flushing sensation; felt anxious; BP 131/87/ BP 131/85/BP 145/76; A spontaneous report was received from a nurse concerning a 34-year-old, female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced flushing feeling, felt anxiety, blood pressure fluctuation, hives around injection site and contralateral arm and chest, diarrhea, shortness of breath, throat tightness and heart rate abnormal.  The patient's medical history included anxiety and attention deficit hyperactivity disorder. Concomitant product use was not provided.  On 09 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) intramuscularly in her arm for prophylaxis of COVID-19 infection.   On 09 Jan 2021 at 13:30, immediately after receiving the Moderna COVID-19 vaccine, the patient reported having a flushing sensation and felt anxious. At 13:36 the patient's vital signs included blood pressure 131/87 mmHg, heart rate 99 beats/min, and oxygen saturation 99%. Doctor noted hives around the injection site and on contralateral arm and chest. Patient was moved to a separate room to lie down on a bed; on route to the new room, the patient developed diarrhea. Treatment included diphenhydramine.   At 13:49, the patient reported having shortness of breath and throat tightness. 99%. Intramuscular epinephrine was given and 911 called. The patient's vital signs included heart rate 133 beats/min and oxygen saturation  At 13:55, the patient's vital signs included blood pressure 145/76 mmHg, heart rate 137 beats/min, and oxygen saturation 99%  At 14:00, emergency medical services arrived, and patient was transferred to hospital. Patient left the office in stable condition with vital signs within expected range and fully conscious.  Action taken with mRNA-1273 in response to the events was not provided.   The events, flushing feeling, felt anxiety, blood pressure fluctuation, hives around injection site and contralateral arm and chest, diarrhea, shortness of breath, throat tightness and heart rate abnormal, were considered resolved.; Reporter's Comments: A spontaneous report concerns a 34-year-old, female patient who experienced serious events of shortness of breath, throat tightness and heart rate increased and non-serious events of flushing feeling, felt anxiety, blood pressure fluctuation, hives around injection site and contralateral arm and chest and diarrhea. The events occurred on the same day after the administration of the first dose of mRNA 1273 (Lot # 026L20A, expiration date unknown). Treatment administered include diphenhydramine and epinephrine. Outcome is resolved. Based on the information provided, which indicates a strong temporal association of the reported events with the administration of mRNA-1273 vaccine, a causal association cannot be excluded. The event of hives around injection site is consistent with the known safety profile of mRNA 1273 vaccine
7 days after injection the arm was inflamed and swollen and red. Fire to the touch. Like needles being stuck on my arm, the next day Saturday, i had most severe headache and chills, Mild fever and couldn't get out of the bed.  Just subsided on Sunday evening. But it is still very sore and a little swelling at the injection site. Dr. was called and told me to take Aleve and ice pack it.
Runny Nose, Headache and a rash that spread to to neck, down the chest and breast are this happen 3 hours after she received the vaccine.  Clinician ordered OTC Hydrocortisone 1% to be applied on the rash.
hair loss/bald; This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (hair loss/bald) in a 76-year-old female patient 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALOPECIA (hair loss/bald). At the time of the report, ALOPECIA (hair loss/bald) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information includes Kaopepto No concomitant information were reported by the reporter   This case was linked to MOD-2021-419602, MOD-2021-419647, MOD-2021-419198, MOD-2021-419419 (Patient Link).
15:54, dizziness. BP 104/65, HR 66, SATS 99%, Resp 16. Drank water, laid down. 16:00, symptoms resolved. 16:09, left ambulating for home. Second vaccine.
Hematoma, bruising. Severe pain in left arm by following morning. Chronic pain in arms, shoulders and neck still (5 months later). Naproxen, tramadol. MRI's & x-rays.
No adverse event; Patient received the Moderna bivalent instead of monovalent for his 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (Patient received the Moderna bivalent instead of monovalent for his 1st dose) and NO ADVERSE EVENT (No adverse event) in a 54-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 015H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Nov-2022, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 11-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (Patient received the Moderna bivalent instead of monovalent for his 1st dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (Patient received the Moderna bivalent instead of monovalent for his 1st dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (Patient received the Moderna bivalent instead of monovalent for his 1st dose).    No concomitant medications were reported. HCP  already got a recommendation from the CDC to repeat the monovalent primary dose on the same day.  Therefore, since patient was still at the facility at the time, patient received a dose of the monovalent Moderna COVID-19 vaccine on 11-NOV2022  of Lot: 083B22A, Expiration date 25-NOV-2022. Patient had not reported any adverse reactions. No treatment information was provided.
rash; This case was reported by a consumer via  interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was not recovered/not resolved.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.  Additional details were provided as follows: This case was self-reported by the patient. The age at vaccination was not reported. The patient got 1st shot and had a bad rash since. The patient would not be getting the 2nd shot.
Nausea, vomiting, diareaha, dizziness, chills, low grade fever
5:00 am following day, fever of 100.4 Extreme fatigue and lethargy
In Dec. of 2020 I tested positive for having COVID-19 by a nasal swab and experienced mild flu like symptoms. On April 12, 2021, I received the J&J Covid-19 Vaccine. The next day I experienced the worst headache I have ever experienced, with splitting head pain for 7+ hours. The following few days I experienced mild fatigue. On May 3rd, 2021 while at work I noticed what I thought was a floater in my right eye. Over the next few days, the floater was still present and I randomly would experience mild pressure behind my right eye. After doing my own eye tests, I quickly realized that it wasn't a floater rather I had lost vision in the lower left part of my peripheral vision in my right eye. Since it didn't limit my activities of daily living, I waited until I had my annual wellness exam on 5/25/21 with my PCP, Dr. at Health. Dr. recommended that I see an Optometrist (please note at this visit I was overdue for my Tdap vaccine and Dr. recommended that I receive this vaccine, which I did). On 6/3/21 I saw Dr., OD at  Eye Care Center. Dr.  noted that I had swelling around my optic nerve in my right eye and had hemorrhages in the back of my eye. She scheduled a follow up and ordered blood work and eventually after another follow up, an MRI of my head and eye. Everything checked out okay and it was at this point that Dr. believed I had, ?Non-Arteritic Anterior Ischemic Optic Neuropathy?. She referred me to see a Neuro-Opthamologist at Health Center. On 7/29/21 I saw Dr., MD and after his examination he believed I did have?Non-Arteritic Anterior Ischemic Optic Neuropathy?. It was his opinion that this was an uncommon condition for someone my age but that I do have risk factors, including a small optic cup, and a history of obstructive sleep apnea (which I am compliant in CPAP therapy since being diagnosed). I was also recently found to have hyperlipidemia with a high LDL cholesterol level (137 on 6/4/21) and also have prediabetes with a slightly elevated hemoglobin A1c (5.8 on 5/25/21). When asked if this could have been a result of receiving the J&J vaccine less than 30 days prior to experiencing my vision loss, he didn?t feel that there was a correlation however that everything about this vaccine is new.  When asked if I should report this event, he stated he did not think there was a relation but he supported my preference to do so.  I am only reporting this not because I absolutely believe the vaccine caused this problem in my eye, but I do have some concerns that it may have contributed to this. I can?t stress enough how horrendous the headache was the next day after receiving the vaccine and with already having covid antibodies in my system at vaccine time, I am concerned about the possibility of this happening to my eye due to the vaccine.  I have no prior history of eye diseases or problems (minus an occasional sty) and have no family history of eye problems either. I am only reporting this in hopes that IF there could be a possible safety concern that I can be part of the solution to making sure these vaccines are safe for everyone going forward.
blegh; Fatigue; aggravated hip bursitis; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (aggravated hip bursitis), FEELING ABNORMAL (blegh) and FATIGUE (Fatigue) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017F21A) for COVID-19 vaccination.     The patient's past medical history included Cancer. Concurrent medical conditions included Achalasia (an autoimmune disorder of the esophagus), Swallowing disorder and Hip bursitis. Concomitant products included PREDNISOLONE and TRAZODONE for an unknown indication.    On 23-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced BURSITIS (aggravated hip bursitis). On 23-Oct-2021, the patient experienced FEELING ABNORMAL (blegh) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Adverse event, at a dose of 1 dosage form. At the time of the report, BURSITIS (aggravated hip bursitis), FEELING ABNORMAL (blegh) and FATIGUE (Fatigue) outcome was unknown.            Patient was given  an optional  7 day course of Concomitant medication of prednisolone for hip bursitis after her booster dose. However patient did not took prednisolone after booster dose.   This case was linked to MOD-2021-393446 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-Nov-2021: Follow-up document received,  Primary reporter detail, patient demographics, Other Relevant History, Suspect drug, Concomitant drug, Treatment drug ,events detail were included and i-Narrative Supplement   was  updated.