chrisvoncsefalvay/vaers-outcomes huggingface dataset:
The vial was stored in the fridge for 2 weeks after puncture; No adverse event; Patients received dose greater than 12 hour post puncture; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received dose greater than 12 hour post puncture), PRODUCT STORAGE ERROR (The vial was stored in the fridge for 2 weeks after puncture) and NO ADVERSE EVENT (No adverse event) in a 5-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Aug-2022 at 8:30 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2022 at 8:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received dose greater than 12 hour post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in the fridge for 2 weeks after puncture) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received dose greater than 12 hour post puncture), PRODUCT STORAGE ERROR (The vial was stored in the fridge for 2 weeks after puncture) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patients received dose greater than 12 hour post puncture) and PRODUCT STORAGE ERROR (The vial was stored in the fridge for 2 weeks after puncture).    Concomitant product use was not provided by the reporter.  Number of doses administered was 3 doses.  The vial was initially stored in the refrigerator on 03-Aug-2022.  The vial was first punctured on 04-Aug-2022 at 8:15 AM.  The vial was stored in the fridge for 2 weeks after puncture and then administered.  The vial did not undergo any temperature excursions.  Total amount of time the vial was exposed to room temperature range (8° to 25°C= 46° to 77°F): 5-10 minutes just to draw up the doses.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-635840, US-MODERNATX, INC.-MOD-2022-635837 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-635840:Patient 2 US-MODERNATX, INC.-MOD-2022-635837:Patient 1
Dizziness, shortness of breath, tight chest, pain up back of neck.  Took to ER. Low BP. Low iron. Given fluids sent home. Was fine for four days. Symptoms now back and worse. Neck tingle has been constant.
This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a adult patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling arm. On an unknown date, the outcome of the swelling arm was unknown. It was unknown if the reporter considered the swelling arm to be related to Shingrix. Additional details were provided as follows: The age group was not reported but it was selected as adult as per vaccine indication. The pharmacist reported that the patient had a severe local reaction to the 1st dose of Shingrix. The reaction was further described as a swollen arm. The pharmacist did not consent to follow up. The pharmacist did not have adverse event information for this event and did not want to be contacted by Safety regarding this event.
Started w/numbness of fingers then fever, chills, n/v & urinary incontinence from 230PM 30OCT91 until approx 8AM 31OCT91; worse @ nite;
A registered nurse reported that a patient (age, gender, race and ethnicity unknown) received the second dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization one month late. Medical history was relevant for hemodialysis. No relevant concomitant medications were reported. On 13-Jul-2021, the patient received the first dose of HEPLISAV-B (Lot # 934598, expiration date and NDC # not available). On 16-Sep-2021, the patient received the second dose of HEPLISAV-B (Lot # 934973, expiration date and NDC # not available). This was one month late from the approved dosing schedule of receiving HEPLISAV-B dose #1 and dose #2 one month apart. The patient was on hemodialysis, and per their policy, the patient was to receive the third dose on 18-Nov-2021. No additional information was provided. Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Spots in vision, dizziness, light headed, passed out multiple times, BP and sugar fluctuations on day of vaccine.  approximate 5 days later developed a fever, vomiting and pneumonia.  currently being treated at Hospital in by Dr.
Patient developed hives on her face (chin and along jawline) about 1 week after receiving first and second dose of HPV vaccine.
pt received JJ vaccine yesterday, chills, bodyaches, fatigue, nausea, denies vomiting/dirahea, pt reports HA 9/10 frontal pressure, pt took tylenol 0400 with some relief
I had no ill reaction-no swelling, no redness, no fever, no trouble breathing at all. By next morning, my Parkinson's symptoms, overall weakness, "frozen foot" and (left) foot-turned-in-bent-at-ankle, resulting in my needing assistance to walk, get up out of chairs, use the bathroom, worse than I had experienced prior. Normally I have much relief with Rytary, Carbidopa-Levodopa, and deep brain stimulator, but nothing helped. I'm now at 65-70% of where I had been. While I can't say with certainty that my medication failure resulted  from the vaccine, I have no  other explanation. I would rather risk whatever one vaccine has done for me against COVID, than go through this again, or worse!
she is getting a hard chill and fever; she is getting a hard chill and fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  An adult female patient received bnt162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for Covid-19 Immunization, reaction(s): "she is getting a hard chill and fever", "she is getting a hard chill and fever". The following information was reported: PYREXIA (non-serious), CHILLS (non-serious), outcome "unknown" and all described as "she is getting a hard chill and fever". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The caller confirmed the Pfizer Comirnaty 2023/2024 vaccine for adults was the product she received. She experienced hard chill and fever and wanted to know if the chills and fever could have been considered normal because all of her Covid shots have been Pfizer and it had always happened.  She got a hard chill last night that lasted about 2-3 hours and then she was just "washed out." She was not hungry but was trying to drink fluids. Every time within the end of the day or 12 hours later, she had a hard chill and a fever. Highest temperature she had was 101.7 She added that she thought the vaccine administrator "got it in the wrong place" in her arm and that was what took time for the fluid. Usually that never happened before and if ever it was gone within 12 hours. The same thing happens. He put in the wrong place in her arm. It had never happened before. Like in the muscle and it did not dissolve. it stayed there. The lady she knew did not get any side effects.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300314657 same reporter/ patient different event dose number;US-PFIZER INC-202300315378 same reporter/ patient/ event  different dose number;
My first side side effect from the vaccine was a painfully swollen, red, and hot to the touch arm at and around the injection site. A few days later I was seen in urgent care for extreme fatigue, asthma symptoms, painful joints, sore muscles, high blood pressure, and brief loss of taste and smell. I was diagnosed with an upper respiratory infection  and told to rest and stay out of work for 2 days.  I was seen again the next day by a FNP at my place of work for the same symptoms, add in weakness.  I was advised to maybe get a send out covid test as all my priors were neg when the send out was positive. I was also told that my symptoms were likely due to side effects from getting the vaccine even though it was a week out from the date of vaccination.  My symptoms have been slowly improving, however as of yesterday, August 13, 2021, my arm at the injection site suddenly started itching and burning and turned red, swollen, and hot to the touch even wit me trying not to touch it.
Gave 0.5 ml dose of flu vaccine to a child who was 2 1/2 years of age, instead of the dose she should have received was a 0.25 ml (6-35 month) flu vaccine.
(EL3247) HIVES HEAD TO TOE 8 MONTH EVENT JOINT ACHE
kidney pain; This spontaneous case was reported by a consumer and describes the occurrence of RENAL PAIN (kidney pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     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, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced RENAL PAIN (kidney pain). At the time of the report, RENAL PAIN (kidney pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       Concomitant medication was not reported. Treatment information was not reported.
Right deltoid - painful, red, swollen, warm to touch.  Warm compress bid.  MEDROL dose pak.
unable to arouse when sleeping;only awoke when in route to ER;nl since;no fever no irritability;hypotonic/hyporesponsive;
Pfizer-BioNTech  Covid-19 Vaccine EUA    First developed body aches, chills around 6 pm, 1/18/21.  Chills continued overnight and when I took my temp in the morning, it was significant at 101.1.   Fever  finally broke around 7pm, 1/19/21.  Felt completely normal the following morning
vial used, was opened more than 12 hours ago;  this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vial used, was opened more than 12 hours ago) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vial used, was opened more than 12 hours ago). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vial used, was opened more than 12 hours ago) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication provided. No treatment medications provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Sep-2021: Follow Up received contains updated reporter's email address.
This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain on left arm coming back on and off), PAIN IN EXTREMITY (Left arm hurt after first vaccine), HYPOACUSIS (Difficulty hearing), INJECTION SITE ERYTHEMA (Redness growing on left arm after first vaccine) and INJECTION SITE ERYTHEMA (Redness on injection site after first vaccine/Redness growing on left arm after first vaccine) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026D21A) for COVID-19 vaccination.  The patient's past medical history included COVID-19 (Long hauler COVID-19) in July 2021. On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced PAIN IN EXTREMITY (Left arm hurt after first vaccine), INJECTION SITE ERYTHEMA (Redness growing on left arm after first vaccine) and INJECTION SITE ERYTHEMA (Redness on injection site after first vaccine/Redness growing on left arm after first vaccine). On 02-Nov-2021, the patient experienced PAIN IN EXTREMITY (Pain on left arm coming back on and off). On an unknown date, the patient experienced HYPOACUSIS (Difficulty hearing). On 26-Oct-2021, PAIN IN EXTREMITY (Left arm hurt after first vaccine) had resolved. On 02-Nov-2021, INJECTION SITE ERYTHEMA (Redness growing on left arm after first vaccine) and INJECTION SITE ERYTHEMA (Redness on injection site after first vaccine/Redness growing on left arm after first vaccine) had resolved. At the time of the report, PAIN IN EXTREMITY (Pain on left arm coming back on and off) had not resolved and HYPOACUSIS (Difficulty hearing) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided.No treatment medications were provided.Patient has refused to see a doctor.Consent received for safety to follow up with daughter (Since patient can not hear well).
No adverse event; temperature excursion / temperature 30.6 F; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 19-AUG-2021, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 ml, lot # T009743, expiration date 27-JAN-2022 (route of administration and anatomical location were not provided) for prophylaxis. The administered vaccine was stored in a temperature of 30.6 degrees Fahrenheit (F) for 26 hours and 14 minutes. Previous temperature excursions were reported: 34.9 F for 1 hour 54 minutes and 48.6 F for 21 hours. No adverse event (AE) was reported.  This is one of three reports from the same reporter. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp. devicelotnumber: T009743; expirationdate: 27-JAN-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2108USA006446: US-009507513-2108USA006422:
Patient was found with AMS 1 day after receiving vaccine.  Patient had pain at the injection site and fever of 103.
HYPERtension & heart racing COVID-19 VACCINE (MODERNA) 0.5 ML ONCE
He died on 21Jun2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID.  A male patient received BNT162b2 (BNT162B2), on 10Mar2021 as dose 1, single (Batch/Lot number: unknown) and on 31Mar2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant) with onset 21Jun2021, outcome "fatal", described as "He died on 21Jun2021". The patient date of death was 21Jun2021. Reported cause of death: "He died on 21Jun2021".  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Reported Cause(s) of Death: He died on 21Jun2021
lost 70-80% of sight; dizzy; ringing in ear; all sounds were coming down a tunnel; A spontaneous report was received from a consumer concerning a 34-year-old old, male patient who experienced 70-80% blindness, dizziness, and ringing in his ear.    The patient's medical history was not provided.  Concomitant product use was not provided/unknown by the reporter.    On 10FEB2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.    Patient got first dose of Moderna vaccine on 10FEB2021 in left non dominant arm. Patient notes he has always had a reaction to anything external going in his body. After receiving vaccine, he felt fine for about 5 seconds then felt dizzy, lost 70-80% of sight and had ringing in his ear. Patient said all sounds were coming down a tunnel. Patient asked for a place to lie down and symptoms resolved about 2 minutes later. Patient wants to know if it is safe to get second dose. Also wants to know if he can change vaccination facility for second dose. Treatment information was not provided/unknown.     The events resolved on same day.; Reporter's Comments: This case concerns a 34 year old, male patient, who experienced a serious unexpected event of blindness transient, among other non-serious events, after receiving first dose mRNA-1273 (Lot# unknown).  Very limited information regarding this event has been provided at this time. Further information has been requested.
UrticariaPruritus fatigue, site redness, itch, hard lump Day 2- fatigue; Day 7 - inj site red, itchy, hard lump; Day 8 - inj site red and itchy; took OTC benadryl for itching
Arm feeling very warm; Redness that is spreading on her vaccination arm; Chills like she had the flu; Chills like she had the flu; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INFLUENZA LIKE ILLNESS (Chills like she had the flu), FEELING HOT (Arm feeling very warm), VACCINATION SITE ERYTHEMA (Redness that is spreading on her vaccination arm) and CHILLS (Chills like she had the flu) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No relevant concomitant medications reported. No relevant medical history was reported.     On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (Chills like she had the flu) and CHILLS (Chills like she had the flu). On 01-Mar-2021, the patient experienced FEELING HOT (Arm feeling very warm) and VACCINATION SITE ERYTHEMA (Redness that is spreading on her vaccination arm). The patient was treated with PARACETAMOL (TYLENOL) for Chills, at an unspecified dose and frequency. On 28-Feb-2021, INFLUENZA LIKE ILLNESS (Chills like she had the flu) and CHILLS (Chills like she had the flu) had resolved. At the time of the report, FEELING HOT (Arm feeling very warm) and VACCINATION SITE ERYTHEMA (Redness that is spreading on her vaccination arm) outcome was unknown.        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.
Pt recvd vax & 8 days p/vax exp elevated SGOT & elevated SGPT;
Lung congestion, deep productive cough, phlegm, throat clearing, mild tachycardia
Moderately sore arm; This is a spontaneous report from a non-contactable consumer. A 54-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6201), via an unspecified route of administration in right arm on 09Feb2021 as single dose for COVID-19 immunisation. The medical history of the patient included blood Pressure, thyroid. The patient's concomitant medications include unspecified medications for blood pressure, thyroid. No Allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 2021 the patient experienced moderately sore arm on an unspecified date. The event was considered as non-serious. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
April 21st (1 week post vaccination): vomiting and diarrhea; resolves after April 22nd April 29th: vomiting, diarrhea, moderate abdominal pain; subjectively much more severe than week prior April 30th: patient seeks Urgent Care, is evaluated and then sent to ER with suspicion of appendicitis. Ruled out via CAT scan. Bloodwork comes back negative for organ failure; doctors conclude stomach flu or vaccine aftereffects are problems; patient sent home w/ instructions for bedrest and symptom-suppressing medication
Headache, muscle aches, and fever reaching 101.8 started at around midnight of 1/9/2021, roughly 8 h after receiving the vaccine. The fever broke this morning (1/10/21) so a rough estimate of the time course is 32 h. The fever was also reduced with acetaminophen. The headache still persists, albeit milder. The muscle aches resolved with the fever, so a time course for that would also be 32 h.  I recently had a COVID19 infection (symptom onset was 12/25/20), but had cleared my isolation date of 1/4/21. The symptoms from my COVID19 infection (headache, muscle aches, chills) had virtually resolved by 1/8/21 before I received the vaccine.
Took place after the 15 minute wait period.  Approximately 30 minutes after injection. Lasted about 15-20 minutes before it passed. MINOR Allergic reaction, burning at injection site, face turned red, nose and lips went numb like a Novocain injection at the dentist. Itch in back of throat but NO swelling or issue breathing.
I woke up with a sore throat. I was exposed to COVID-19 at a party. I woke up with a sore throat that went away after about 4 hours. Before bedtime, I had a fever of 101 and I was feeling kind of weak like I was coming down with something. I was not able to talk, it was like I could not push enough air out of my vocal I was not feeling really bad when I was initially sick. My teeth still hurt like all of them need a root canal. My lips have turned purple, my teeth pain gets really bad. I wake gasping for air. My temperature rose to 102.0. I had a cough and was coughing up white foam. On January 08th I started taking PAXLOVID which was prescribed by a doctor at urgent care. My fever was already starting to go away by the time I started taking the medication. It was 98.9. I started getting intermittent electrical shock like feeling in the back of my head. I got really bad stomach cramps and explosive diarrhea, and my fever went back up to 100.4. The sore throat returned. I lost all my taste and smell. They told me that I was having nerve spasms for inflammation. I was taking TYLENOL to treat the symptoms. I also had a dry cough. I was also getting nasal nerve pain and on the left side of my face I had nerve pain and teeth pain. I am definitely better, but my taste and smell occasionally go out. I was prescribed gabapentin for nerve pain on the 11th and I started having ear issues. I went to see my ENT. I lost hearing in my left later on. It still occasionally goes out for no reason. I was prescribed 60mg prednisone and my hearing returned to normal. The PAXLOVID was not effective in treating the symptoms. My symptoms are getting better, but the symptoms recur occasionally.