chrisvoncsefalvay/vaers-outcomes huggingface dataset:
About 24 hours after receiving my 2nd dose I started to feel very fatigued and had brain fog that has been going on for over  72 hours since shot. I?m also experiencing headaches, mostly at the top of my head. Headaches also have been off and on for over 72 hours
After screening patient for vaccine eligiblity, RN Vaccinator attempted to give 0.5ML of Fluzone vaccine in patient right arm.  When giving this initial injection, an undetermined amount of FLUZONE vaccine was leaking from the injection site. RN vaccinator alerted Clinical Manager who consulted with Pharmacist , regarding the situation.  Per protocol, it was advised that client should be revaccinated.  Client informed of situation and reccomendation for re-vaccination and agreed to get re-vaccinated with 0.5ML of FLUZONE . 2nd Dose was administered in Right arm without any problems.  Pt. reported no side effects.
My left eye spontaneously started bleeding (>10-20ml).  I had been working from home on a computer and speaking on the phone at the time of the event.  This was not proceeded by any type of injury, rubbing, etc.  I applied direct pressure until bleeding stopped enough to remove my contact lenses, then proceeded to the emergency room.
tested positive for covid; runny nose; Fever; body ache; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for covid), RHINORRHOEA (runny nose), PYREXIA (Fever) and MYALGIA (body ache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced RHINORRHOEA (runny nose), PYREXIA (Fever) and MYALGIA (body ache). On 24-Mar-2021, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid), RHINORRHOEA (runny nose), PYREXIA (Fever) and MYALGIA (body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     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 for the event was provided. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Mar-2021 and was forwarded to Moderna on 25-Mar-2021.    This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (tested positive for covid), RHINORRHOEA (runny nose), PYREXIA (Fever) and MYALGIA (body ache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History Information was reported.     On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Mar-2021, the patient experienced RHINORRHOEA (runny nose), PYREXIA (Fever) and MYALGIA (body ache). On 24-Mar-2021, the patient experienced COVID-19 (tested positive for covid). At the time of the report, COVID-19 (tested positive for covid), RHINORRHOEA (runny nose), PYREXIA (Fever) and MYALGIA (body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-2 test: positive (Positive) POSITIVE.     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 for the event was provided.
Pt. feels nauseated, headache is ongoing, sensitive to light, fever of 102.0, pain in arm & leg (injection sites).
I had a routine mammogram and ultrasound and the results were abnormal, I am scheduled for a follow-up biopsy of my  left axillary lymph node.
Patient reported area swollen, red, itchy and she felt off over the weekend. There was no action taken. She reports improvement.
I tested Positive for Omicron COVID on 12/16/2021. I had a fever, chills, sore throat, cough and I lost my taste and smell. It very was mild and I was sick for 5 days. I didn't go to the hospital because I was still able to breath. I did stay in for an additional 5 days, to make sure I was better. For as am concern the vaccine worked.
I had the shot but I have shingles/Suspected vaccination failure; I had the shot but I have shingles; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The age group of patient was not reported however was captured as an adult as per vaccine indication. The patient got Shingles after vaccination. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, laboratory confirmation, time to onset of shingles were unknown at the time of reporting.
Severe headache, difficulty swallowing, hives on arms and legs. Took her to clinic.
Weakness in left bicep and forearm -- has not improved since onset. Slight numbness.
Left upper leg anterior aspect, reddened, swollen, child ambulates with slight limp. Mom reports warm to touch on 6/18/06. No increase temperature per moms report. Referred to PMD for evaluation.
Information has been received from a 67 yr old female receptionist with acid reflux, sulfa allergy and a history of a splenectomy who in 2000 and on 24Nov04 was vaccinated with a first and second dose of pneumococcal 23v polysaccharide vaccine, respectively (second dose lot 649912/0529P). There was no illness at the time of vaccination. Concomitant therapy included levothyroxine Na (Synthroid), ethinyl estradiol (+) levonorgestrel (Preven), estrogens, conjugated (Premarin) and pantoprazole sodium (Protonix). That same day, the pt developed swelling, erythema and tenderness at the site of vaccination. On 26Nov04, the pt was evaluated by her doctor and was treated with ice, naproxen sodium (Naprelen), and acetaminophen (Tylenol) prn. On 02Dec04, a follow up call was made and revealed that the pt was doing much better and had recovered. No product quality complaint was involved. Further information is not expected.
Severe sore throat, congestion in throat, bronchial tubes.  Severe cough Lots of phlegm....all clear, no color. No fever.
chills; extreme exhaustion; it took a substantial amount of effort to walk from the bedroom to the kitchen; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administration date 24Mar2021 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 2021, outcome "unknown", described as "chills"; FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "extreme exhaustion"; GAIT DISTURBANCE (non-serious) with onset 2021, outcome "unknown", described as "it took a substantial amount of effort to walk from the bedroom to the kitchen".  Additional information: Patient stated that she had experienced chills after both her initial doses of the Pfizer COVID-19 Vaccine, as well as the booster shot. She also stated that she had experienced "extreme exhaustion" for about a week after each shot, stating that it took a substantial amount of effort to walk from the bedroom to the kitchen.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
After about 12 hours after vaccine, had bad body shakes for 3 days; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8730) via an unspecified route of administration in the left arm on 06Apr2021 at 15:00 (at the age of 34-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medication. On 07Apr2021, 12 hours after the vaccination, the patient experienced bad body shakes for 3 days. It Started to go away by 10Apr2021. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event bad body shakes was resolved on 10Apr2021, after the duration of 3 days.   No follow-up attempts are needed. No further information is expected.
rash itchy; Throat started to swell; Bad rash from head to toe; This spontaneous case was reported by a nurse and describes the occurrence of PHARYNGEAL SWELLING (Throat started to swell), PRURITUS (rash itchy) and RASH (Bad rash from head to toe) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jan-2021, the patient experienced RASH (Bad rash from head to toe). On 10-Jan-2021, the patient experienced PHARYNGEAL SWELLING (Throat started to swell). On 12-Jan-2021, the patient experienced PRURITUS (rash itchy). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency and FAMOTIDINE (PEPCID AC) at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (Throat started to swell), PRURITUS (rash itchy) and RASH (Bad rash from head to toe) was resolving.        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 concomitant medications were provided by the reporter; Sender's Comments: Based on the current available information and temporal association between the use of the product and the events, a causal relationship cannot be excluded.
13 days after 2nd vaccine woke up with extreme vertigo, could not walk, ear pain, severe neck, ear and head pain. Existing tinnitus and hyperacusis worsened.  Steroid taper, Meclizine.
Fussy, temperature 100-101, injection site red, swollen, hot to touch, painful within 48 hours.
Accidental administration of 1.0 mL instead of 0.3 mL. Error identified immediately. Patient informed. Patient monitored for 30 minutes. No side effects reported by patient. Patient contacted next day and reported sore arm and fatigue. No further reported side effects.
Moderna vaccine was administered outside of Facility- reported by patient ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------------------------- T78.3XXD ANGIOEDEMA, SUBSEQ 5/2/2023 OSTEOARTHRITIS OF LEFT KNEE T78.3XXD ANGIOEDEMA, SUBSEQ 5/2/2023 OSTEOARTHRITIS OF LEFT KNEE
Suspected vaccination failure; Shingles; Pain; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a adult patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows:  The age at vaccination was not reported.  The age group was not reported but was captured as adult as per vaccine indication. The patient had the shingles vaccine and 4 weeks after receiving covid-19 vaccine, the patient experienced shingles.   The reporter reported that understand there was a new shingles vaccine we should all be getting and get it and save yourselves pain. This case was considered to be a suspected vaccination failure case, as the details regarding being full vaccination schedule, laboratory confirmation for shingles and exact time to onset were unknown. It was unknown if the reporter considered the shingles and pain to be related to covid-19 vaccine.
Information has been received from a healthcare worker concerning an unknown number of patients of unknown age and gender. The patient's medical history, concurrent condition and concomitant therapy were not provided. On unknown dates, the patients were vaccinated with 7 doses of (Merck) PROQUAD, lot # K022447, expiration date 13-MAY-2016 (dose and route not provided). The temperature excursion with (Merck) PROQUAD was supported with in-house stability data. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested.
12/27/2021 Event occurred after 2nd vaccine.   83-year-old male presenting for sudden onset weakness and chronic falls. he does have a fever of 101 today however he states he has not had fevers or chills but has felt progressively more fatigued over the past couple days and has had a cough which started yesterday.
Omicron; Omicron; illness; 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.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Omicron"; ILLNESS (non-serious), outcome "unknown", described as "illness". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive for omicron.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Hemorrhagic stroke in temporal lobe resulting in >7cm hematoma.  Symptoms starting with painful migraine that started 2 days after the vaccine.   On 4/2, migraine was worse and then loss of vision in right eye around 9pm.   4/3 at 6am, became disoriented with weakness on the right side of the body. Vomited. Called 911, paramedics said symptoms were in line with stroke. Took to hospital to ER. Immediately went in for CT scan. Result was large bleeding into the brain, approx 6cm. Transferred to unit to monitor, bleeding increased by 10 to 20%.  4/4 at 10am, left side craniotomy for evacuation of hematoma performed. Patient was in critical care icu.  4/9 patient transferred to inpatient rehabilitation. Patient diagnosed with Wernicke's Aphasia and Level 2 Dysphagia, visual field cut in right eye, and right sided weakness.
Administered ProQuad and Varivax, pt did not have any adverse event or reaction.
Headache, Sedation, Myalgia, Arthralgia, Fever, Painful/Swollen lymph nodes Narrative:  Other Relevant History:
? fever for about 24 hours, up to 38.5 ? chills ? headache/pain back of the head ? nausea ? menstruation started 8 days earlier (about 30 hours after the shot) ? swollen left upper arm, redness
PATIENT STATED THAT AFTER HER FIRST PFIZER INJECTION  (EXP:8/31/21) RECEIVED 4/20/21 HER LEFT SIDE JAW BECAME TINGLY AND ITCHY WITH REDNESS THAT COVERED HER FACE. THIS HAPPENED APPROXIMATELY 1/2 TO ONE HOUR AFTER RECEIVING VACCINE. UPON DISCRETION OF THE PHARMACIST AND LPN AN ORAL DOSE OF DIPHENHYDRAMINE 25MG WAS GIVEN TO THE PATIENT, WITH MOTHER'S PERMISSION, WAS GIVEN AFTER DOSE WAS GIVEN JUST AS A PRECAUTION. PATIENT WAS CONTINUALLY MONITORED UNTIL 12:45PM WITH NO REACTION. PATIENT STATED JUST FEELING A LITTLE TIRED. PATIENT AND MOTHER THEN LEFT PHARMACY
At approx. 1700 vacc were administer (DTAP-Hob-IPV, Hep B, PCV13, Rotavirus) child was ongoing unconsolably for approx. 8-10 min. Provider was notified and provider assessed the pt.
Booster dose; Bad headache; Her arm hurts from the top of her hand to the top of her neck, she could not lift her arm; Can't lift her arm; laying on her back for the last 24 hours; 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.  A 64 year-old female patient received bnt162b2 (COMIRNATY), administration date 18Nov2021 (Lot number: FG3527) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1), for Covid-19 Immunization, reaction(s): "mild soreness at the injection site"; Bnt162b2 (Dose: 2), for Covid-19 Immunization, reaction(s): "mild soreness at the injection site". The following information was reported: IMMUNISATION (non-serious) with onset 18Nov2021, outcome "unknown", described as "Booster dose"; HEADACHE (non-serious) with onset 18Nov2021, outcome "unknown", described as "Bad headache"; PAIN IN EXTREMITY (non-serious) with onset 18Nov2021, outcome "unknown", described as "Her arm hurts from the top of her hand to the top of her neck, she could not lift her arm"; MOVEMENT DISORDER (non-serious) with onset 18Nov2021, outcome "unknown", described as "Can't lift her arm"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 18Nov2021, outcome "unknown", described as "laying on her back for the last 24 hours".  Additional Information: Patient looks on the internet Patient sees there is the Pfizer BioNTech Covid-19 vaccine and the Comirnaty Covid-19 vaccine so Patient was curious if they are all the same? Caller states when patient received the first two Pfizer doses Patient only had mild soreness at the injection site but when Patient received her booster dose yesterday Patient was experiencing a completely different reaction. Patient started having a reaction only 5 hours after receiving the booster dose. Her arm hurts from the top of her hand to the top of her neck, she could not lift her arm, Patient has had a bad headache and Patient has been laying on her back for the last 24 hours. Patient is a 64 year old female that received her booster dose yesterday. Lot number for the booster dose FG3527.Caller would like to know if the Pfizer booster dose she received is the same as the first two Pfizer doses to explain the different reaction Patient was having to the booster dose?The transferring agent stated that Patient has a caller on the line that was calling about the Pfizer Covid-19 Vaccine Booster and reported that Patient received the booster yesterday 18Nov2021. The first 2 doses she had mild soreness at the injection site. With the booster, her arm is hurting from her hand to the her neck. Patient can't lift her arm. Patient has a bad headache and has been laying on her back for the last 24 hours. She started feeling this way 5 hours after the booster dose.   Follow-up attempts have been completed and no further information is expected.
Immediately after IM injection the client c/o nausea and attempted to vomit, c/o dizziness, tingling and numbness of tongue. Was taken to the ER where blood work was done and later sent home.
pt recvd vax; mom states inconsolable cry; inject site red and swollen; T 99.8;
Information has been received from a nurse referring to an unknown number of patients of unknown age and gender. No relevant medical history or concurrent conditions were reported. Since 13-OCT-2015, these patients were vaccinated with doses of oral, ROTATEQ (lot # L013188, expiration date 02-NOV-2016, oral; dose and frequency not reported) which were exposed to temperatures outside of the recommended range. No adverse experiences had been reported. This is one of two reports received from the same reporter. Additional information has been requested.
Patient reported that she suddenly had chest pain and abdominal pain. The pain was significant enough that she had to sit down and was not able to move for about 1 hour after. Pulse and blood pressure were both elevated about 10 minutes after symptoms started - BP systolic was over 180 and pulse was over 120bpm. She reported that she had checked her blood pressure and pulse prior to the vaccine and she was "normal" at about 130s/70s. She did not have any rash or redness around the site of injection, she also did not have any difficulty breathing or any dizziness. She reported that her chest pain was on the left side and after about 20-30 minutes, her chest pain started to subside. Abdominal pain persisted but at about 1 hour after symptoms started, she wanted to go home. Patient was advised to go to the ER or urgent care of symptoms persisted.
This spontaneous report was received from a pharmacist, via company representative, referring to a 75 year-old patient of unknown gender. Information regarding the patient's medical history, concurrent conditions or concomitant medications was unknown. On an unspecified date in February 2018, the patient was administered PNEUMOVAX 23 and again on unspecified date around August 2018 (Inappropriate schedule of drug administration) because the patient initially said she never received the PNEUMOVAX 23 before; no clarifying information was provided. No adverse effects were reported.
A dose of the Moderna vaccine was given to the client for second dose instead of Moderna. Client showed up at the site to receive his second dose of the Covid Vaccine. During registration he stated to the data entry person that his first dose of the vaccine was the Moderna. Again, when answering the questions from the consent form he states "Yes, my first dose of the Covid Vaccine was the Moderna. A dose of Moderna was given to the client for his second dose of the Covid Vaccine instead of PFIZER, which the client had received previously. Patient requested a Moderna vaccine since he already got his first Dose on the 8/18/21. I confirmed with the patient that he received Moderna. Since my computer wifi was down I proceeded to finish his paperwork and informed the nurse pt would like Moderna. Nurse administered the Moderna. My wifi started working and I was able to pull his information and I saw he was previously given Pfizer. Since the patient left I informed nurse.