chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via call center representative and described the occurrence of injection site itching in a 53-year-old female patient who received FLULAVAL QUADRIVALENT (batch number 5S349, expiry date 31st May 2017. On 7th November 2016, the patient received FLULAVAL QUADIRVALENT .5 ml. On 8th November 2016, 1 days after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site itching. On an unknown date, the outcome of the injection site itching to be almost certainly related to FLULAVAL QUADRIVALENT. Additional details were provide as follows: This case was previously reported to a doctor. The reporter was a nurse practitioner at GlaxoSmithKline medical clinic. The patient visited the emergency room. The patient visited doctor for itching at injection site after vaccination with FLUALVAL Quadrivalent.
Vaccines administered evening of 4/17/07, client did not have any adverse effect until next day. States while in school started feeling weak and dizzy, this progressivly became worse, but did not require leaving school. That night symptoms still occuring and worsening. "almost drunk -like" Mother callled ER at Hospital. Instruced to give Benadryl. Client Slept through night. Remained "dizzy and uncoordinated: the next morning, received more Benadryl. Symptoms resolved that day. No rash during initial episode, but did C/O rash over majority of body, possibly hives, about 2 weeks after immunizations. Benadryl given about TID during this episode and rash lasted about 3 days.No further symptoms. Informed of these events on 6/19/07 when client came in for HPV #2, incident reviewed by Medical director and order obtained to give HPV #2, request that family call Health Department for any problems.
RT hip and groin pain, unable to bear weight. Unable to touch right hip or leg. Swelling and rash to hip region. Patient was placed in the hospital for 3 weeks (6/24/13-6/26-13, 7/8/2013-7/11/2013, 7/23/2013-7/26/2013- 1st hospital) (9/11/20103-9/14/2013- 2nd hospital). Seen a number of physicians for hip and groin pain- had a number of medical images- had a nerve block x2. Did Physical therapy for a number of months- both land and water therapy. Tried HBO therapy.
Shot was given and after 4 hours I could not move my arm up more than 6 inches from my body. Worked and went home iced the areas all night. This has continued every day for the entire months of Oct. Soarness and unable to move daily. Wakes me up nightly.
2hrs post-vaccination - fatigue, headache, malaise 12hrs post-vaccination - above plus chills and arthralgias 18 hrs post-vaccination - fever to 101.7 plus above Resolution of fever 36hrs post-vaccination, Resolution of headache, fatigue, chills, arthralgias 48 hrs post-vaccination On day 2 developed localized redness, swelling, tenderness and itching at injection site that has persisted so far (today is day 3)
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Nurse). The reporter is the patient.  A 43-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 16Aug2021 as dose 1, single (Lot number: FC3180) and on 07Sep2021 as dose 2, single (Lot number: FF2588) at the age of 41 years for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Cephalosporins" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Neosporin, reaction(s): "known allergies: Neosporin". Vaccination history included: Pertussis vaccine, reaction(s): "known allergies: Pertussis vaccine". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jan2023, outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received Paxlovid as treatment of COVID-19 from 13Jan2023 to 17Jan2023.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the events (DRUG INEFFECTIVE, COVID-19 ) and BNT162B2.
Date of Admission: 10/16/2022 Date of Discharge: 10/18/2022 Presenting Chief Complaint:  Chief Complaint Patient presents with o Corona Virus Concern   Hospital Principal Problem (Discharge Diagnoses): 1. COVID-19
5 days after my first Pfizer injection, I had aural fullness & pressure, left ear greater than right and tinnitus much higher than baseline, more so on left side (same side as injection). This has slightly gotten better ~ 6 weeks after first dose, but is not fully back to baseline. I have taken Flonase every day in an effort to gain some relief and occasional Ibuprofen.  After much hesitancy, I received the 2nd dose on 4/28/21 and two days later felt nauseous, dizzy,  headache and feel like I am off balance (rocking on a boat) and motion sickness. Sometimes I get episodes where I get shaky, very dizzy and as if I might faint. I have never felt like this prior to the vaccine. My PCP put an order in to check my A1C to check blood sugar levels and everything was normal. I have had no change in my diet. I do eat a balanced healthy diet. Prior to the vaccine I would exercise regularly and lead a healthy lifestyle.
Fever; Chills; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PAIN (soreness at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 15-Nov-2020.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.            No Concomitant Medications were provided. No Treatment History was provided.
L thigh swelling, erythema, and pain for several days that took 2 weeks to completely resolved. No fevers. No treatment given.
Fever; Body aches; Pins and needles in my hands and feet.; Headache for 4 days; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8735) via an unspecified route of administration in the left arm on 22Apr2021 at 18:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included irritable bowel syndrome and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included amitriptyline (MANUFACTURER UNKNOWN) from an unknown date for an unknown indication and unknown if ongoing. The patient previously took metoclopramide (REGLAN) and experienced drug allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. The most concerning side effect was pins and needles in the patients hands and feet. It started on 22Apr2021 at 20:00, 2 hours after she got her vaccine. It was constant for about 72 hours, and had been off and on daily, since then. Sometimes it would be in other areas, like arms or legs for a few seconds, but mainly it was her hands and feet. The patient also had a headache for 4 days, a fever on 23Apr2021, the day after she got her vaccine, and body aches that lasted about 24 hours. The patient reported she was afraid to get her second dose because she was afraid the pins and needles would get worse. The events resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events fever and body aches were resolved on 24Apr2021 after the duration of 24 hours and headache was resolved on 26Apr2021 after the duration of 4 days, while that of the event pins and needles in hands and feet was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
every time I cough it hurts; it is very irritated; nose that I have very congested; When I cough, my back, ribs and head hurt.; coughing; sneeze a lot; dry throat; it ran dry to my nose; my arm hurt; the area where I was vaccinated swelled; my voice began to diminish as if I was going to have a very bad flu; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (my arm hurt), DRY THROAT (dry throat), NASAL DRYNESS (it ran dry to my nose), SNEEZING (sneeze a lot) and COUGH (coughing) in a 51-year-old female 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 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PAIN IN EXTREMITY (my arm hurt), INFLUENZA LIKE ILLNESS (my voice began to diminish as if I was going to have a very bad flu) and VACCINATION SITE SWELLING (the area where I was vaccinated swelled). On 19-Mar-2021, the patient experienced DRY THROAT (dry throat) and NASAL DRYNESS (it ran dry to my nose). On 20-Mar-2021, the patient experienced SNEEZING (sneeze a lot). On 21-Mar-2021, the patient experienced COUGH (coughing). On an unknown date, the patient experienced COUGH (every time I cough it hurts), IRRITABILITY (it is very irritated), NASAL CONGESTION (nose that I have very congested) and PAIN (When I cough, my back, ribs and head hurt.). At the time of the report, PAIN IN EXTREMITY (my arm hurt), DRY THROAT (dry throat), NASAL DRYNESS (it ran dry to my nose), SNEEZING (sneeze a lot), COUGH (coughing), INFLUENZA LIKE ILLNESS (my voice began to diminish as if I was going to have a very bad flu), COUGH (every time I cough it hurts), IRRITABILITY (it is very irritated), NASAL CONGESTION (nose that I have very congested), PAIN (When I cough, my back, ribs and head hurt.) and VACCINATION SITE SWELLING (the area where I was vaccinated swelled) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information included Medicine for sinusitis (acetaminophen, guaifenesin, phenylephrine HCI). she only took one dose but did not see any improvement. she also took medicine for the cold and flu ( dexcromechorthan HBR). she took two doses but it did not help.
Pain- redness - firm - Golf ball size tender to touch- greater than 48 hours later.
Extreme dizziness, darkened vision as happens before losing consciousness, feeling of losing consciousness. All symptoms repeated in 5 waves. First wave hit about 10 min after dose and last about 60 seconds. 2nd wave hit a minute later and lasted approximately 30 seconds. 3rd wave hit 2 minutes later and lasted about 60 seconds with some shaking in core/diaphragm area.  4th wave hit 8-10 minutes after that and lasted 5 minutes. 4th wave was precipitated by shaking starting in diaphragm area and branching out to extremities and jawline. Shaking was uncontrollable and made speaking impossible. Shaking passed after about 6 minutes when wave subsided. 5th wave hit about 10 minutes later and was dizziness/darkening vision with disorientation, no shaking.  EMS responded to first wave by removing me from my car and having me sit in a chair, removing my mask to breath better, took vitals. Vitals were taken several times, oxygen levels varying from 93 - 98.  Oxygen was ready nearby but not used. Blood pressure varied, don?t have the readings. EMT gave water immediately and then pretzels about 30 minutes after the episodes began. I was kept for observation for an hour total after inoculation and then released to go home as symptoms had fully subsided.
COVID-19 positive on 28Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19 positive on 28Apr2022) in a 76-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Apr-2022, the patient experienced COVID-19 (COVID-19 positive on 28Apr2022). At the time of the report, COVID-19 (COVID-19 positive on 28Apr2022) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Apr-2022, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Spikevax) (Unknown) dosing remained unchanged.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter.  Other vaccines were not given within 1 month prior to Moderna COVID-19 vaccine.   The patient did not experience a similar event in the past.  The event had caused patient to seek medical care.  Treatment details were not reported by the reporter.  Company comment: This is a spontaneous case concerning a 76-year-old female patient with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The patient experienced COVID-19 one day after the first dose of mRNA-1273 (Spikevax) vaccine. No Concomitant or treatment medications details were provided. Outcome of the event was reported as resolved at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.     This case was linked to MOD-2022-600165 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 76-year-old female patient with no relevant medical history, who experienced the unexpected non-serious event of Covid-19. The patient experienced COVID-19 one day after the first dose of mRNA-1273 (Spikevax) vaccine. No Concomitant or treatment medications details were provided. Outcome of the event was reported as resolved at the time of this report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
arm swelling, tingling and numbness ipsalateral arm and face, chest and back tightness for 10 days, sx much more mild but still persistent
At bedtime noted slight itching in R. upper arm - didn't really pay any attention to it.  Today patient has 8mm x 10mm raised reddened area on R. shoulder over deltoid area.
2/18/03 Rash (hive-like) no itching on arms, neck-lips swelling, had take antihistamine, feeling some better. Advised to see put MD, ER, or Urgent care could get worse. 2/19 - no rash today, doesn't feel normal, no energy general feel bad, no further swelling. Did not see MD. To call with further prob's or if doesn't feel better to see put MD. 2/25 - Feeling much better but not back to normal. Declines seeing MD.
Rash on arms and  legs  . resolved after taking a dose of Benadryl
Burning sensation along entire spinal column. Was very uncomfortable; Burning sensation along entire spinal column. Was very uncomfortable; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 23Oct2023 at 15:00 as dose 1, single (Lot number: HG2649) at the age of 56 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies: Penicillin" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for influenza immunisation, on 05Oct2023 as dose number unknown, single; RESTASIS; ROSUVASTATIN; UBRELVY; MULTIVITAMIN [VITAMINS NOS]. The following information was reported: BURNING SENSATION (non-serious), DISCOMFORT (non-serious) all with onset 24Oct2023 at 13:00, outcome "recovered" (Oct2023) and all described as "Burning sensation along entire spinal column. Was very uncomfortable". Therapeutic measures were not taken as a result of burning sensation, discomfort.  Additional information: Facility type vaccine: PRIVACY. Patient did not had COVID prior vaccination. Patient did not tested COVID post vaccination. Burning sensation along entire spinal column. Was very uncomfortable and lasted about two hours.  No follow-up attempts are possible. No further information is expected.
About 2 weeks after Pfizer COVID 19 vaccine 1st shot,  I developed significant tinnitus in both ears which still persists to this date.   I have some hearing loss too.   I?m not getting the second shot.
Bad reaction to the booster dose; Felt warm; Temperature of 99.6 degrees/ slight fever; Experienced bad headaches 2 hours after the vaccine/ the headache lasted for two days.; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction to the booster dose), FEELING HOT (Felt warm), PYREXIA (Temperature of 99.6 degrees/ slight fever), HEADACHE (Experienced bad headaches 2 hours after the vaccine/ the headache lasted for two days.) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939905) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer vaccine. Past adverse reactions to the above products included No adverse event with Pfizer vaccine. Concomitant products included ESCITALOPRAM and MELOXICAM for an unknown indication.    On 29-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Nov-2021, the patient experienced HEADACHE (Experienced bad headaches 2 hours after the vaccine/ the headache lasted for two days.). 29-Nov-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced VACCINATION COMPLICATION (Bad reaction to the booster dose), FEELING HOT (Felt warm) and PYREXIA (Temperature of 99.6 degrees/ slight fever). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Headache, at an unspecified dose and frequency. On 29-Nov-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, VACCINATION COMPLICATION (Bad reaction to the booster dose), FEELING HOT (Felt warm) and PYREXIA (Temperature of 99.6 degrees/ slight fever) outcome was unknown and HEADACHE (Experienced bad headaches 2 hours after the vaccine/ the headache lasted for two days.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.6 (High) 99.6 Fahrenheit.         Patient stated that he thinks he received the full dose for his booster dose.
Palpitations, Angina, Tachycardia, ventricular tachycardia Narrative:  Proceeded with Cardiac CTA in April to confirm no CAD. Most likely mild case of myocarditis that resolved
headache; fatigue; sore arm; breathing problems when she is walking fast.; This is a spontaneous report from a contactable consumer reporting for herself. A female patient of unspecified age received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration on 13Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 15Jan2021, at the time of report, the patient experienced headache, major fatigue, sore arm and breathing problems when she is walking fast. She was told to sit down and report the issues according to the instructions provided to her. She said she was going to do that when she got home and will rest up for the day. She did not sound winded when and had good speech. She calmed down and she was ok. Outcome of the events was unknown.   Information about Lot/Batch has been requested.
Persistent headache x 3 days,.  Bitemporal headache developed the morning after receiving the vaccine and is associated with photophobia.  The patient has treated with headache with OTC tylenol and ibuprofen with minimal improvement.  She has not had any periods of time without headache.  No blurred vision, no double vision.  No nausea or vomiting.  No weakness or loss of balance.  Normal neuro exam in the office.
A day after the shot I was in the shower and started experiencing exhaustion and shortness of breath. I also had tachycardia. I proceeded not to feel well they?re very next day. Then on Friday I was dizzy and a coworker said that I was flushed and I wasn?t feeling well. I proceeded to go see patients and while examining a patient I became very dizzy and lightheaded while bent over and almost passed out when I came up.. at that time I decided to leave work and go to my PCP. Orthostatic?s were positive and EKG showed normal sinus rhythm and an echo is ordered. Echo was normal. Throughout the week I continued to have tachycardia and shortness of breath with any type of exertion. I left work this morning and was tested for Covid because of my symptoms.
Patient received the vaccine and 5 minutes later stated he became warm to touch, and walked to the cooler to get a bottle of water and fainted. He was found on the ground with no pain or injuries per patient. He stated he still felt warm. Patient refused 911 transport. Patient stated he had a history of fainting with a previous H1N1 vaccine. Patient did not have any difficulty breathing or itching.
Received the shot approximately 3pm. At 6:30 was so tired I had to go to bed and finally slept. Got up about 8pm. Small headacke, weakness, small problem breathing. Felt like I might fanit. Heaviness in the chest. Could feel my heart beat. Anxious. Thought maybe I may be having a panic attack, but didn't. Ringing in the ears way louder than normal. I thought I was starting to get better about 9:25 but the anxiety started again. Went back to bed felt like I was going to faint. Heart felt like it was beating faster than normal. Now a stomache ache. Felt like a panic attack Got up at 11pm. Felt better, then some diarrhea. After midnight I felt better but my tummy hurt a little. Went back to bed. Fell asleep about 1:30. Got up about 9:30. Do feel much better but not completely normal. Of course the shot site hurts.
I received my Covid 19- Vaccine on 09/22/2022. On the evening of the 09/29/2022 I saw flashes in the right eye.  The next day around 10:00 am I noticed a new floater in right eye. I went to the eye doctor the same day and was confirmed there was a new tiny spot of blood in front of retina in right eye.   Floater have not resolved.
Patient stated he has difficulty to move his arm and he has muscle weakness. He can?t lift  anything heavier than 5 pounds. He said he felt very painful for couple days after geting the shot. He took tylenol as needed for  pain. He still has sharp pain when he tries to lift something.
Fever of 104 for about 10 hours, went up to 105 for about an hour during the day.  Severe neck and head pain, throbbing.  Body aches, chills, lack of appetite and significant malaise.