chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Got COVID-19 and Miserable with symptoms exactly like we have virus again; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (Got COVID-19 and Miserable with symptoms exactly like we have virus again) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Got COVID-19 and Miserable with symptoms exactly like we have virus again). At the time of the report, COVID-19 (Got COVID-19 and Miserable with symptoms exactly like we have virus again) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   This case was linked to MOD-2021-315958.
Per parent, patient began to develop redness around the injection site on her left leg.  Patient also developed a low grade fever.  Mom took patient to the ER on 4/8/10 due to fever and loss of appetite.  Patient was seen in the office today because she had a fever of 104, injection site on left leg was swollen, hot to the touch, and looked purple.  Patient had a normal CBC.  Sent home with ATARAX RX.
staes had a rash w/white bumps on legs & arms w/itching in some areas;onset 22JUL98 that applied lotion w/o relief;sx are worse in arm, better by afternoon;
The weekend after felt flu like symptoms tenderness at the site, burning sensation down side of torso and arm pit, shoulder pain radiating to neck. Pain gets sharper bit localized on neck area only.
States she got covid 19 infection in 2022 and then now. Mentions that she received pfizer covid vaccine primary series and booster; States she got covid 19 infection in 2022 and then now. Mentions that she received pfizer covid vaccine primary series and booster; States she got covid 19 infection in 2022 and then now. Mentions that she received pfizer covid vaccine primary series and booster; 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 61-year-old female patient received BNT162b2 (BNT162B2), in Mar2021 as dose 1, single (Batch/Lot number: unknown), in Apr2021 as dose 2, single (Batch/Lot number: unknown) and on 23Nov2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing), notes: Caller states she has diabetes but it is controlled with diet and exercise. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 2022, outcome "unknown" and all described as "States she got covid 19 infection in 2022 and then now. Mentions that she received Pfizer covid vaccine primary series and booster"; DISEASE RECURRENCE (medically significant) with onset 2023, outcome "unknown", described as "States she got covid 19 infection in 2022 and then now. Mentions that she received Pfizer covid vaccine primary series and booster". The patient specified that at the time of this report it was her 2nd time getting covid. The first time was only sniffles. She stated she got covid 19 infection in 2022 and then at the time of this report (e.g. 2023). The patient stated that this was the 4th day since her symptoms started. She will be picking up her prescription for Paxlovid today.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Nausea - resolved within 36hrs post-dose Swollen, painful lymph nodes in injection arm/neck - started about day 2 and is ongoing (now a week later) Large red rash at injection site occurred today (one week later)  - painless
Pt. called today to report a rash she noted around the site of the TDAP that was given on 08/20/08.  Describes as a rash or hives that was at the site of injection travel down towards the elbow and now going up her neck.  States getting a little better today, but never called to report this eposide.
Triage: Patient calling because the injection site of her pneumonia shot is red, hot, and itchy. She states the issue is spreading. She had the injection on Wednesday. Phoned pt. No trouble swallowing or breathing. The center of injection site is light colored The red area is 2-3 inches above elbow and almost goes to inner arm.
Tinnitus, dizziness, brain fog.  Tinnitus is constant 24/7.
Severe muscle cramps like extensor muscles locking up in back , arms & legs , severe nausea, blurred vision , light headness . With the 2nd shot the same again but add rash , increased BP ( high! ) . The pain in my muscles lasted 4 months ( 24/7)  in my arms , legs & back, proprioception issues with my R leg  , then it for the most part stopped and remained in my ankles & feet, and I feel like some cognitive issues  .  I still get waves of pain all over lasts for a couple of hours verses 24/7, I have a strange sensation constantly if my arms , legs & back .
Was given a bivalent Moderna shot instead of Monovalent shot number 2 in the series
FELT GROGGY; TIRED AFTER THE VACCINE;TIREDNESS; PREVALENT RED MARK ON ARM; Arm has been pulsing, arm is still pulsing sporadically; Sore arm; FELT ITCHY AT INJECTION SITE;ITCHNESS; INTERNAL HIVES; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (FELT GROGGY), VACCINATION COMPLICATION (TIRED AFTER THE VACCINE;TIREDNESS), URTICARIA (INTERNAL HIVES), LIMB DISCOMFORT (Arm has been pulsing, arm is still pulsing sporadically) and MYALGIA (Sore arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (FELT GROGGY), VACCINATION COMPLICATION (TIRED AFTER THE VACCINE;TIREDNESS), URTICARIA (INTERNAL HIVES), LIMB DISCOMFORT (Arm has been pulsing, arm is still pulsing sporadically), MYALGIA (Sore arm), VACCINATION SITE PRURITUS (FELT ITCHY AT INJECTION SITE;ITCHNESS) and ERYTHEMA (PREVALENT RED MARK ON ARM). At the time of the report, SOMNOLENCE (FELT GROGGY), VACCINATION COMPLICATION (TIRED AFTER THE VACCINE;TIREDNESS), LIMB DISCOMFORT (Arm has been pulsing, arm is still pulsing sporadically), MYALGIA (Sore arm) and ERYTHEMA (PREVALENT RED MARK ON ARM) outcome was unknown and URTICARIA (INTERNAL HIVES) and VACCINATION SITE PRURITUS (FELT ITCHY AT INJECTION SITE;ITCHNESS) had resolved. Not Provided      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.   Concomitant medications includes Thyroid Medication.  No treatment information were reported.   Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received on 21-Apr-2021: added reporter information, update patients tab, updated products tab, update events and added events prevalent red mark on the arm as  and arm has been pulsing; arm is still pulsing sporadically.
Patient given flu shot (seasonal) at 11:00 a.m. and approx 20 mins later developed flushing hives. Never any development of respiratory sx or anaphylaxis. Treatment consisted of patient monitoring admin of oral antihistamine and IM SOLUMEDROL.
Red rash, mostly on torso. Slowly spreading to arms and legs. Some on face/head. Flat red spots, not itchy. Disappear when pressure applied.
Generalized muscle pain, fatigue, weakness, left upper quadrant abdominal ache, and restarted menstrual cycle after 8 months of cessation.
After receiving his 2nd Pfizer shot he ambulated to the observation area with his friend.  Went to sit down , c/o of dizziness and had a syncopal episode with seizure like activity for 1 minutes.  Hit the left side of his forehead, red spot with no open areas present.  EMS present, stabilized on floor with BP 140/85  Pulse 54  Sat's 96% RA.  Monitor placed with NSR present.  Denies any pain, SOB or discomfort.  Friend stated no history of seizure and medical history except allergies. Stated he has not eaten or drank anything since last night.  EMS transitioned to stretcher and pt became unresponsive with seizure like activity, eyes rolling back.  EMS transported to hospital for further evaluation.
This case was reported by a consumer via call center representative and described the occurrence of Guillain Barre syndrome in a 77-year-old female patient who received Influenza vaccine Quadrivalent 2017-2018 season for prophylaxis. Concomitant products included Aspirin, atenolol, CITRACAL, Coq10, fish oil and lisinopril. On 11th September 2017, the patient received Influenza vaccine Quadrivalent 2017-2018 season (intramuscular). On 11th September 2017, less than a day after receiving Influenza vaccine Quadrivalent 2017-2018 season, the patient experienced injection site pain. On 12th September 2017, the patient experienced Guillain Barre syndrome (serious criteria GSK medically significant) and weakness in extremity. On an unknown date, the outcome of the Guillain Barre syndrome, injection site pain and weakness in extremity were recovered/resolved. It was unknown if the reporter considered the Guillain Barre syndrome, injection site pain and weakness in extremity to be related to Influenza vaccine Quadrivalent 2017-2018 season. Additional details were provided as follows: The patient's concomitant medication included CENTRUM SILVER. The patient reported that 1 day after vaccination, she experienced weakness in her legs and arms and low grade Guillain Barre Syndrome. The patient reported that she was evaluated by her physician.
AM of 8/10/02 about 48 hours, post vax, pt developed temperature of 101F, irritability and vomiting. Early that evening, pt had an apparent life-threatening event and was transported to ER. Pt was noted to be lethargic. Pt started on Zantac for GER. Discharged after 48 hours of hospitalization secondary to negative work-up.
Patient was stable and alert, proactively  given emesis bag at 1515  Treatment/intervention B/P and O2sat monitored, in reclining chair.VS as follows: 1537 B/P 155/73, P80, R16, Sp02 99% 1545 B/P 144/74, P80, R12, SP02 98% 1535 reclined in chair, Icepack to neck 1550 B/P 133/77, P77, R12, SP02 99% 1600 states feeling "normal" but also states continued nausea and tingling in hands and fingers 1600 ER charge nurse phone and Patient to ER for check in via wheelchair
Increased heartbeat, heart palpitations, significant increase in blood pressure at 150/90, for a healthy young 23 year old who would usually receive a blood pressure test of 120/70 during normal circumstances. Inability to sleep or stay asleep since the vaccination, every time I attempt to fall asleep, heart rate increases, convulsion occurs followed loss of feeling in extremities. Cognitive decline, inability to remember certain events, and communication skills have greatly diminished.  Reduced Appetite. Neurological Symptoms (Numbness throughout body, Entire body is numb). Anxiety Attacks.
My COVID-19 infection symptoms  started on 10/21/2022 congestions in  my head and chest. I had fatigue, low grade fever, body aches, and headaches. I took a home COVID-19 test on the next day 10/22/2022. I did a telehealth on 10/24/2022 with my doctor who then prescribed me Paxlovid but I didn't use  it because I was already feeling better.
Treatment of COVID-19/tested positive for antigen and PCR; Treatment of COVID-19/tested positive for antigen and PCR; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 86-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose  2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19/tested positive for antigen and PCR". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for antigen and PCR; Positive, notes: tested positive for antigen and PCR. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid. Clinical course: No other medication in 2 weeks. No Known allergies. The patient had disease recurrence developed cough and sore throat and tested positive for antigen and PCR on 30Apr2022.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
I am a healthy 41 year old male who was diagnosed with Labyrinthitis and sudden sensorineural hearing loss following the second dose of my covid vaccine.  I had no health problems and no prior hearing issues prior to this diagnosis.  I thought this could be relevant to the adverse event so I?m including it here - I  tested positive for Covid-19 in January 2021 but had a mild case and fully recovered in the normal timeframe (less than 2 weeks). On 6/25/21, 38 days following my second Covid vaccine (Moderna lot 009C21A), I experienced sporadic dizziness while working at my computer.   That evening, I woke up at approximately 2am with severe vertigo  - vomiting, extreme dizziness, fullness in my right ear, and tinnitus.  I saw a general practitioner on the morning of 6/26/21 who removed excess ear wax in my right ear and sent me home with no prescription or diagnosis.  There was no noticeable hearing loss at that time.  The evening of 6/26, dizziness continued, but not nearly as severe as the prior evening.   I also had mild throbbing and ringing in my ear for the next couple days.  On the evening of 6/29, I woke up in the middle of the night with another vertigo attack - severe dizziness and vomiting like the earlier episode.   When I woke up on 6/30, the hearing in my right ear was completely gone and I was unable to walk without assistance due to the loss of balance, vertigo, and vomiting.  I made an appointment at urgent care and had to be taken in a wheelchair.  Recognizing that I lost the hearing in my right ear, the Dr. provided an urgent referral to an Ear Nose and Throat (ENT) doctor.  I saw the ENT that day, who ordered a hearing test.  The audiogram showed profound hearing loss in my right ear across all frequencies and I was diagnosed with Labyrinthitis and sudden sensorineural hearing loss.  The ENT prescribed a high dose of oral prednisone and scheduled an intratympanic steroid injection.  After 2 months, I completed 2 rounds of oral steroids, 6 steroid injections, and over 15 hyperbaric oxygen therapy (HBOT) treatments.  My latest audiogram, 2 months after the onset, showed moderate to profound hearing loss in my right ear, but the profound loss is in the frequencies where most human conversation occurs and my word recognition score is less than 20%, even at high volumes.  While I have regained my balance and can perform most activities normally (including  sports), I still have some residual balance/vestibular issues that have not fully corrected since the incident.  I also have constant tinnitus.  The ENTs have indicated the hearing loss I sustained and the tinnitus are permanent.
Chest pain day after vaccination...had to take nitroglycerin to relieve symptoms..no adverse effects according to patient
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 22-year-old female. Neither medical history nor concomitant medications were reported. On 27-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
Pt had not been feeling well 2-3 days previous to vaccine and has hx of asthma. However, approx. 4-5 hrs after vaccine pt developed increased HR, SOB and feeling that throat was closing. Also had HA and nausea. Treated with VENTOLIN and BENADRYL. (+) improvement noted within 1 hr. Feeling better on 7/30/14.
Erythema approximately 1 1/2 inch around normal size site, fever, sore lymph nodes under arms.
the first shot, the girl didn't get it in the muscle very well, its hard to do in her skinny arms, her arm was very sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administered in arm left, administration date 08Feb2021 (Lot number: EN5318) at the age of 65 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Anxiety" (unspecified if ongoing), notes: Takes medicine for it; Situational, known to have panic attacks, heart races, she gets dizzy.; "panic attacks" (unspecified if ongoing); "heart races" (unspecified if ongoing); "gets dizzy" (unspecified if ongoing); "cholesterol is still high" (unspecified if ongoing), notes: had blood work done prior to vaccine; going to start the statins soon; "red count is on the high side" (unspecified if ongoing), notes: had blood work done prior to vaccine; not too high to be alarmed about. Family history included: "High blood pressure" (unspecified if ongoing), notes: Takes medicine for it; diagnosed 10 years ago and runs in the family. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Feb2021, outcome "unknown", described as "the first shot, the girl didn't get it in the muscle very well, its hard to do in her skinny arms, her arm was very sore". Additional information: Concomitant medications included unspecified treatments for high blood pressure and anxiety. The patient doesn't think she got the first dose of the vaccine the right way. The patient was going to take naproxen sodium (ALEVE) but thought it might interfere with the vaccine. She doesn't want to wear a mask anymore and was previously reluctant to get the vaccine but thought she needed it.  No follow-up attempts are possible. No further information is expected.
a tingling feeling on her top lip that was also puffy; a tingling feeling on her top lip that was also puffy; headache; eye itching; 2 hives on her arm; sore arm; cheeks were a lot of color; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A female patient of an unspecified age received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 1 via an unspecified route of administration on 06Jun2021 (Batch/Lot number and Expiry date was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 06Jun2021, the patient experienced a tingling feeling on her top lip that was also puffy, headache, eye itching, 2 hives on her arm, sore arm and cheeks were a lot of color. It was reported that the patient had the first dose of the Pfizer COVID-19 vaccine last Tuesday (06Jun2021) and 48 minutes after, she had a tingling feeling on her top lip that was also puffy. She also had headache (in which she took Tylenol afterwards), eye itching, 2 hives on her arm (in which she thought were mosquito bites but she said they were not because the shape looked like hives instead of the circular mosquito bites), sore arm, and her cheeks were a lot of color. She was primarily concerned about her upper lip. It has been 2 days and she was still feeling the tingling sensation until today. She wanted to know how long it would last. She also wanted to know if she should be worried about taking the second dose of the vaccine . In response it was mentioned that as noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. She was suggested to speak to her healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection as healthcare provider knows her health situation and has access to information that can better help inform this decision. She also wanted to know if she should take something for her adverse event like a Benadryl. In response it was suggested that Pfizer was unable to make treatment recommendations and referred her to HCP. Therapeutic measures were taken as a result of headache. The clinical outcome of the events was unknown.  Information about batch/lot number has been requested.
I went to the pharmacy to get my 4th COVID-19 shot. After that I went home and was feeling well. I had some aches in my arm by the next day I was fine. About 5 days I started getting symptoms of not feeling well the tiredness, cold like symptom and I did a home test of COVID-19 and I was positive. I already did another test and are negative but still continue with the raspy voice.
04/14/2022 at nighttime, I got hives all over my body and I haven't changed any dietary or even detergent. On 04/18/22 I went to the urgent care and told them what was happening and they said they have seen a lot of people who had COVID-19 and got the booster get hives. I was taking Benadryl from the 14th-18th and it was not working. When I went to urgent care, they told me to try Xyzal during the day and Benadryl at night and it was getting better but on 05/02/22 I got huge hives again and I still have not contacted my Doctor and I am still on the Xyzal and Benadryl at night. When I went to urgent care it was going into my ears and it was everywhere.
This spontaneous report as received from a health professional refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with a dose of PNEUMOVAX 23 (administration route, lot number and expiration date were not reported). No concomitant therapies were reported. The day of vaccination it was discovered that the content of one of the PNEUMOVAX23 syringes was empty. Only condensation was observed in the unit, this problem caused the patient to delay the start of his therapy. No adverse event symptoms were reported. Additional information has been requested.
Pt presented to the ED with dizziness, lightheadedness, chest pressure and shortness of breath.  Patient received her COVID booster prior to developing symptoms and then came to the hospital for blood work.  Before getting her blood drawn she began to note the above symptoms.  She does not have any known history of respiratory disease.  She did not have any adverse reactions to any of her previous COVID vaccines. She developed tachypnea, and diffuse wheezing bilaterally. She was treated with benadryl, solumedrol epinephrine and nebulizer.