chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Lowgrade fever; Chills; Tachycardia; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia), PYREXIA (Lowgrade fever) and CHILLS (Chills) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Seasonal allergy. Concomitant products included LEVONORGESTREL (KYLEENA) for Birth control, VITAMIN C [ASCORBIC ACID] for Immune disorder (NOS), CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for Seasonal allergy, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Vitamin D deficiency.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2021 at 8:30 AM, the patient experienced TACHYCARDIA (Tachycardia). On an unknown date, the patient experienced PYREXIA (Lowgrade fever) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 18-Feb-2021, TACHYCARDIA (Tachycardia) had resolved. At the time of the report, PYREXIA (Lowgrade fever) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Electrocardiogram: normal (normal) normal. On an unknown date, Heart rate: 140 (High) heart rate remained high for about 15 hours..         Treatment included  fluids. Action taken with mRNA-1273 in response to the events was not Applicable   This case was linked to MOD-2021-044470 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jun-2021: Follow up received on 7-Jun-2021, reporter details, patient demographics, patient date of birth, concomitant medications, event (tachycardia) start date, stop date were added. Outcome for the event tachycardia was updated to recovered from unknown.
fever on Wed; deltoid became swollen & hot red Thurs; arm twice size of other;
Just noticed a  noticeable bump in the arm at the site of injection that vaccine was given  2 weeks after injection. Somewhat sensitive to touch and about 2"x3".    It might have been there sooner, but did not notice.  My husband had the same vaccine, the same date, but no bump.  Not a critical reaction, but thought I should report it.
High dose annual flu vaccine no longer available. Patient was informed of differences between high dose flu formulation and 'regular' dose (for under 65yo) and consented to receipt of lower dose formulation of annual flu vaccine.
Patient presented to pharmacy pursuant to being seen in the ER to pick up prescriptions for Prednisone and Hydrocodone/APAP to treat Right arm pain and edema of unknown etiology or diagnosis.  She was wearing a splint, her fingers, hand an wrist were noticeably swollen and she stated they were painful and tender / hot to touch.  Pain starts in the wrist and travels up the arm.  I only inquired about the relationship to vaccination as I saw in our work que that she had been vaccinated less than a week earlier.  She did not mention this to the doctor in the ER but I advised her to do so with her next doctor visit if necessary.  She does not recall any type of injury, but that the pain and swelling just came out of the blue.
Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). In March 2022, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) and POOR QUALITY PRODUCT ADMINISTERED (Moderna Covid-19 vaccine which has undergone multiple temperature excursions.  Twenty six  patients received the vaccine in question.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient received vaccine as a booster dose and does not have information available on the patients first two doses. Storage condition at the time of the excursion is refrigerated storage. Maximum Temperature reached is 49 degrees Fahrenheit and Minimum Temperature reached is 37.7 degrees Fahrenheit Vial moved from freezer to refrigerator on 3-MAR-2022. The Nurse reports no adverse reactions or side effects to the Moderna Covid-19 vaccine. Proposed desired use by date was reported to be on 16-Mar-2022. The temperature excursions occurred on 4-Mar-2022, 5-Mar-2022, 7-Mar-2022, 8-Mar-2022, 9-Mar-2022 and 10-Mar-2022. Treatment information was not reported.
This spontaneous report was received from an X-ray technician concerning an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency, lot #, expiration date and indication unknown). No adverse symptoms were reported. The vaccines were exposed to temperature of 47 F to 77F for an unspecified period of time, there was also a previous temperature excursion of 47 F to 77F for an unspecified period of time. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1708USA004979.
Sleepy; Tired; Grandchildren who are below 18 years of age; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Sleepy), FATIGUE (Tired) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Grandchildren who are below 18 years of age) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (Sleepy), FATIGUE (Tired) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Grandchildren who are below 18 years of age). At the time of the report, SOMNOLENCE (Sleepy), FATIGUE (Tired) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Grandchildren who are below 18 years of age) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       It mentioned that this occurred with the reporter's grandchildren who are below 18 years of age. No concomitant medications were reported. No treatment medications were reported.   This case was linked to MOD-2022-533772, MOD-2022-533725 (Patient Link).
headache 8 hours scratchy throat 8 hours joint aches 8 hours stuffy nose 5 hours tingling and itchiness lower lip, not resolved
Exactly two weeks after vaccine - my son broke out in the most terrible rash with blisters and bumps all over his body.  Also, had a fever for 36 hours.    His skin looks absolutely terrible.  It is so scary.
Per patient: shortly after injection felt pain in opposite arm and was having slight trouble breathing/clearing throat. Patient didn't report symptoms to clinic staff and returned to work after the observation period. Around an hour after receiving the injection, the symptoms were getting worse enough to call for help. She returned to the vaccination clinic and an EpiPen was administered (911 was also activated).
Mom noticed redness on leg surrounding injection site after patient woke up from nap @ 3:30 PM today. No fever, acting slightly more fussy, no cough or breathing changes. Upon arriving at office, CPNP describes reaction as mild erythema on right thigh 2" x 2.5" in diameter surrounding the injection site, no fluctuance, no pain on palpation. She stated the redness seemed to "come and go" while she was in the room. Mom and dad stated the redness was "much less" when in office than it was earlier.
Approx 12 hours after second dosage of Pfizer Covid vaccine, I became nauseous and had chills. Then diarrehea began. Next, vomiting and diarrehea began (at the same time).
"1/12 Vaccinated at 6pm. *pm chills and mild rigors started. 1/13/21 Woke up with difficulty walking due to severe joint pain. Legs weak.  By 3pm I was in bed for 16 hours with fever of 101-103. Uncontrolled rigors for 3 hours, headache, severe joint pain, dizziness and weakness. Took Tylenol every 8 hours and Motrin every 8 hours." Day of report "symptoms are subsiding but joint pain, weakness in legs, and low grade fever continue."
Patient mistakenly given 2 doses of Pfzier vaccine on the same day. Administration error acknowledged immediately after injections were given. Patient was observed 45 minutes and sent home with instructions to take pain/fever reducer medication in case of any pain and/or fever. Patient is to return with any problems and/or follow up as needed.   Patient showed no symptoms, reactions, or signs of distress.
Left arm and shoulder pain, unable to raise arm - symptoms progressed/worsened over the next 1-2 weeks.
After she received the 1st dose, she tested positive with the virus; After she received the 1st dose, she tested positive with the virus; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT/Batch number and expiration date unknown) via unspecified route of administration on 14Mar2021 at single dose for COVID-19 Immunization. Medical history and concomitant medications were not reported. Patient received the 1st dose of the vaccine last 14Mar2021 and she was scheduled to get the 2nd dose on 04Apr2021. After she received the 1st dose, she was tested positive with the virus. She was not sure if she should take the 2nd dose or she needs to wait. She tried to look around and she didn't find a specific answer. Patient also mentioned that she had fever for 2 days but it was gone at time of reporting. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
16 hrs p/vax pt found by parent 1AM crying w/temp (ear temp) of 105.2; APAP given & pt wiped w/cool cloth; w/in 1 hr t99 (ear temp); no other s/s or change in behavior, neuro or feeding; mom instructed to notify MD 16AUG94 & cont to observe
Began with upper GI stomach pain early afternoon. 6:30pm felt very tired. 8:30pm had uncontrollable shivering and fever of 101.3. Fever remained throughout the night and rose by early morning to 101.5. Slight nausea and headache as well. About 8am next morning it eased with ibuprofen. Was able to function the second day but extremely tired.
A member called today to inform us that she thinks she had a side effect of Pfizer Covid-19 2nd shot received on Nov 20th. She felt dizzy and had congested nose, so she went to urgent care on Dec 1st as she does not have a Primary Care Physician. The urgent care doctor told her that if she thinks it is related to the vaccine, she should contact the pharmacy so they can report it.
Swollen arm; Swollen arm and difficulty lifting it; This is a spontaneous report from a contactable consumer via Pfizer Sales Representative.  A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on an unspecified date at single dose for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced swollen arm and difficulty lifting it on an unspecified date with outcome of unknown.   Information on the batch number has been requested.
Thursday 11/18 - Friday 11/19 had very normal reaction including chills, low fever, headache.  On Saturday 11/20 Developed vaginal swelling/ discomfort and an ulcer on right labial area.   On Sunday 11/21 visited urgent care to get the ulcer looked at. Swabbed ulcer to test for Herpes simplex (1 +2) [NEGATIVE], Chlamydia + Gonorrhea [NEGATIVE].  Doctor recommended 5 days of Acyclovir (400mg) orally while waiting for Herpes results. Discontinued the Acyclovir once the results came back negative.   Ulcer went away without additional treatment on 11/25.
Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) and PRODUCT STORAGE ERROR (Some doses that may have been administered past 30 days from being thawed/The vaccines were applied to patients after being refrozen) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications reported.  No treatment information was provided.
chill; temp at 1200 was 100.4 and at 1830 101.7; shortness of breath; body aches; headache; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) solution for injection via an unspecified route of administration in the right arm on 18Dec2020 at 16:30 (at the age of 59-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history and concomitant medications were not reported. The patient previously took cefadroxil (DURICEF) and experienced allergies. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was diagnosed with COVID-19 in Apr2020. On 19Dec2020, the patient experienced chill, temp at 1200 was 100.4 and at 1830 101.7, shortness of breath, body aches and headache. No treatment was provided for the events chill, temp at 1200 was 100.4 and at 1830 101.7, shortness of breath, body aches and headache. The outcome of the events chill, temp at 1200 was 100.4 and at 1830 101.7, shortness of breath, body aches and headache was not recovered. Since the vaccination, the patient has not been tested for COVID-19.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
This spontaneous report as received from a medical assistant refers to unspecified number of unspecified patients. On unknown dates the patients were vaccinated with improperly stored VAQTA lot # K012457 (lot # M011116 expiration date 17-JUN-2017 and lot # K012457 expiration date 04-JUN-2017). No adverse effects reported. This report is for data logger. The vaccines were exposed to the following exposures: 1.6 degree centigrade for 1 hour 48 minutes (rounds to 2 degree centigrade). 1.4 degree centigrade for 4 hours and 40 minutes. 1.5 degree centigrade for 1 hour 17 minutes (rounds to 2 degree centigrade). Previous excursions included: 1.7 degree centigrade for 25 minutes (rounds to 2 degree centigrade). 1.4 degree centigrade for 2 hours and 32 minutes. 1.4 degree centigrade for 3 hours and 36 minutes. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date, the patient missed an unspecified dose of GARDASIL (dose, route and lot number were not reported) due to a product defect. No adverse effect was reported. Product quality complaint was filed. Additional information has been requested.
25 year old was administered Fluzone High Dose, no AE; 25 year old was administered Fluzone High Dose, no AE; Initial and follow up information received on 06-Sep-2019 and 10-Sep-2019 regarding an unsolicited valid non-serious case received from a other healthcare professional.  This case is linked to cases 2019SA251863 and 2019SA251857 (same reporter).  This case involves a 25 years old male patient who was received vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot UJ232AA, Exp. Date 10-Apr-2020) via intramuscular route in the left deltoid on 06-Sep-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error case due to inappropriate age at vaccine administration.  It was also a case of overdose.  At the time of reporting no adverse reactions were reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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.  List of documents held by sender: none.
No adverse events at this time. The patient received a double dose of the bivalent Pfizer vaccine. He received his first dose on 12/13/22 and second booster dose on 3/15/23.
He has muscle pain; Has fever; This is a spontaneous report from a Sponsored Program. A non-contactable consumer (patient) reported that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 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 was not reported. The patient's concomitant medications were not reported.  The patient has muscle pain and fever on an unspecified date. The outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Administer expired vaccine to 450 patients after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) in a 69-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 070H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administer expired vaccine to 450 patients after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was reported.  The vial was initially stored in the refrigerator reported as unknown. Number of doses/vials was reported as 173 doses.  The vial did not undergo any temperature excursions.  No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up received included reporter details updated.
On 10-30-08 client woke up with a headache, she took ASA and it went away. Also had headaches on 11-1-08 and 11-2-08 and took ASA and it went away. On 11-1-08 client states her rib area is very sore and still very  sore today. She thinks it is due to flu shot because it is he first flu shot
Difficulty blinking one eye, which progressed to unilateral facial weakness.  Symptoms consistent with Bell's Palsy.
Vaccinated twice with the first dose of Moderna Covid19.had been given the vaccine 15 days apart; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Vaccinated twice with the first dose of Moderna Covid19.had been given the vaccine 15 days apart) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jul-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 experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated twice with the first dose of Moderna Covid19.had been given the vaccine 15 days apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (vaccinated twice with the first dose of Moderna Covid19.had been given the vaccine 15 days apart) outcome was unknown. No concomitant drug details were reported. No treatment details were reported.
24hr p/vax fever, diffuse macular papular rash which has 3 days later;
This spontaneous report was received from a health professional referring to a 26 year old patient of unknown gender. Information about the patient's medical history and concurrent conditions was not provided. On an unknown date, while being 26 years old, the patient was vaccinated with a dose of PROQUAD (administration route, lot number and expiration date were not provided). No concomitant therapies were reported, neither was any adverse event. Additional information has been requested.
Per mother stated he had a very slight rash face, neck on Monday after vaccines given. On Tuesday his left eye swollen up, pt itching. But I did not call on Tuesday. Rash is worse today (Wednesday). Rash to right upper arm, face, neck. Mother was advised to bring pt into clinic to be assessed. Pt assessed by APRN.