chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient brought to the ED by EMS on 11/13 for weakness and decreased responsiveness. EMS reported the patient is suspected to not have eaten for the past 2 days.  She tested positive for COVID by PCR in the ED. Ultimately patient was admitted 11/13/22 - 11/20/22 with acute metabolic encephalopathy secondary to septic shock requiring an ICU admission and pressure support. She was found to have a subacute CVA, severe hyperglycemia without DKA, and COVID pneumonia. Patient was on oxygen and started on dexamethasone, which was eventually stopped. Patient was discharged to home on 11/20. She has received the COVID primary vaccine series and one booster.
Fever; Head ache; Chills; This is a spontaneous report from a contactable other-HCP (patient). A 57-year-old female patient received and received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EN6205) via an unspecified route of administration on 24Feb2021 14:20 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number EL3247) via an unspecified route of administration on 27Jan2021 14:15 as dose 1, single for covid-19 immunization. It was reported, patient missed her appointment for the second dose on 17Feb2021. On 24Feb2021, the patient experienced fever, headache and chills. The outcome of the events was unknown.   No follow-up attempts are needed. No further information is expected.
Narrative: Patient received two doses of Pfizer COVID 19 vaccine. The patient tested positive for COVID 19 on 8 Jan 2022. The patient presented to the ED with cough and tachycardia. The patient was admitted on 8 Jan 2022 with a diagnosis of COVID Supraventricular tachycardia. The patient was treated with adenosine. The patient was discharged in stable condition on 10 Jan 2022. Reported per EUA.
Patient experiences generalized hives. Patient went to the doctor's office on 04/23/12 and was treated with prednisone and an intramuscular injection of DEPO-MEDROL. The symptoms lasted a coupled of days after treatment. Patient recovered.
Bitter taste in mouth and was eating very little because of bad taste; Sore left arm, it felt like someone punched her; Fatigue; body aches; not being able to taste anything. it came back but it taste bitter; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 16Mar2021 09:41 (Lot number: EP7534, Expiration Date: 31Jul2021) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "diagnosed allergies" (unspecified if ongoing); "compromised immune status" (unspecified if ongoing); "Respiratory illness" (unspecified if ongoing); "genetic /chromosomal abnormalities" (unspecified if ongoing); "endocrine abnormalities (including diabetes)" (unspecified if ongoing); "endocrine abnormalities (including diabetes)" (unspecified if ongoing); "very high blood pressure" (unspecified if ongoing), notes: prior to getting the vaccine. There were no concomitant medications. The following information was reported: AGEUSIA (non-serious) with onset Mar2021, outcome "recovered with sequelae", described as "not being able to taste anything. it came back but it taste bitter"; DYSGEUSIA (non-serious) with onset 17Mar2021 03:00, outcome "not recovered", described as "Bitter taste in mouth and was eating very little because of bad taste"; PAIN IN EXTREMITY (non-serious) with onset 17Mar2021 03:00, outcome "recovering", described as "Sore left arm, it felt like someone punched her"; FATIGUE (non-serious) with onset 17Mar2021 03:00, outcome "not recovered", described as "Fatigue"; PAIN (non-serious) with onset 17Mar2021 03:00, outcome "not recovered", described as "body aches".  Additional Information: The vaccine was administered at a clinic at a church. The patient has no family medical history. Prior to vaccination the patient was not diagnosed with COVID-19. It was reported that the patient can eat and drink, but it was hard because everything taste bitter like the taste in her mouth. She cannot drink coffee with creamer because it was so bitterer. Everything was so bitter. The patient does not know if it was a side effect or if she should get a COVID test. The day after the report will be a whole week that it has been going on. She called her doctor's office and they advised to contact Pfizer. Events did not result to emergency room nor physician office visit. Return date for second dose was scheduled for 06Apr2021.  No follow-up attempts are possible. No further information is expected.
Vaccine given at 1530 on 12/2, my daughter woke up on 12/3 at 0230 with complaints of difficulty breathing, difficulty swallowing, sore throat, and feeling like a rock was in her throat.  She did not have any wheezing on auscultation.  I gave her 25mg Benadryl and her symptoms subsided shortly after.  I monitored her at home, and she had no recurrence of symptoms.  We did not need to seek emergency medical care.
12/21/2020 4:30PM itching throat, clearing of throat, lump in throat, coughing, very dry throat, coughing sensation to remove "something" in throat, fat tongue/throat feeling, throat feeling as if closing, coughing fit --- pt transferred to ER. Panic attack, unable to breath feeling --medications via IV -- Benadryl (flushed), Pepcid and steroid for inflammation)  administered. Heart monitored while receiving treatment. Discharged at 08:00 PM with prescription for Benadryl and steroid Prednisone.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a physician via a company representative concerned a 40 year old female of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  Patient received vaccine 6 months ago, then had very mild 4 to 5 days bout of Covid-19. It was reported that the patient had Polymerase chain reaction (PCR) positive (confirmed covid-19 infection and confirmed clinical vaccination failure) and became well. Reporter wanted to know if patient should get booster and if so or if between the original vaccine and the confirmed illness was he likely to be as immunized. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed covid-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210947468-Covid-19 vaccine ad26.cov2.-Confirmed Clinical Vaccination Failure . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS.
Patient is a 46-year-old female who has known history of previous reactions to immunizations with anaphylaxis as well as seizures who presented to the emergency department with some symptoms after receiving Covid vaccination.  She reported onset of some mild headache and dizziness as well as ringing in her ears.  She states that these are symptoms sometimes that precede a seizure episode.  She has managed on Keppra 750 mg twice daily and has been on this regimen for some time.  Here in the emergency department she had no significant concerning findings on exam.  Vital signs were fairly unremarkable, there was no rash, there is no stridor or throat swelling, lungs were clear.  There is no seizure activity or any other neurological findings.  I spoke at length with the patient and her significant other regarding this symptomatology but I do not see any reason at this time that she would need to be admitted to this hospital.  She could still potentially develop a seizure-like episode although I do not anticipate this to be the case.  There is definitely nothing at this time that would point towards anaphylaxis.  There was a Keppra level that was drawn and is pending at this time.  I have sent a letter to neurology to let them know that it is still pending at this time.
Pharmacist gave patients expired doses of Moderna COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist gave patients expired doses of Moderna COVID-19) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist gave patients expired doses of Moderna COVID-19). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Pharmacist gave patients expired doses of Moderna COVID-19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   patient was monitored for 15 min after and had no symptoms.  No concomitant medications was reported. No treatment drug details was reported.
After 3 months wating period post infection; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (After 3 months wating period post infection) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 prophylaxis.    No Medical History information was reported.   On an unknown date, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form On an unknown date, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. and third dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (After 3 months wating period post infection). At the time of the report, COVID-19 (After 3 months wating period post infection) outcome was unknown.            Concomitant medication was not provided.  Treatment medication information was not provided by the reporter.  It was reported that event third dose hid bad and it was better than the second.  This case was identified as part of a retrospective clean-up activity where certain emails received in the moderna mailbox were missed to be booked-in
Patient given wrong dose (1 cc given).  Reported slight Lt deltoid soreness 5 hrs after injection.
Loose the control on the body, Head spinning because of this can't seat or stand without help not able to walk or get up from the bed.
approx 24 hours after injection I became lethargic and spiked a fever for almost 24 hours of 101.8, not effected by acetaminophen.  My left arm became extremely painful and extremely hard to extend up or lean/lay on .
5 days post vaccine developed very sore reddened upper arm continuing on across her chest. Dx lymphangitis mild cellulitis.
patient presented for first COVID 19 vaccine.  Immediately after injection patient became dizzy, foggy, diaphoretic, blurred vision, nausea and had one episode of vomiting. After patient had emesis episode patient immediately returned to baseline and felt better.  Patient stated that he normally had some type of reactions after injections.  Patient was observed for a full 30 minutes and given water.  1225 patient check on and a this time had made a complete return to baseline.  Patient discharge home after his full 30minute observation period ended at 1230
Patient stated at the time of the vaccination it felt sore. pt was advised vaccination will make them sore for a few days. patient states pain has not improved over time. she felt the vaccination hit her bone
pt recvd vax in lt arm & 24 hrs noted pain/swelling 48 hrs later noted swelling/redness dec elbow; evaluated in ER;
Cough, CXR with faint patchy infiltrates in left lung is greater than right, indicating pneumonia
MENSTRUAL CYCLE - My period is consistent every 5 weeks. From my first vaccine, a month earlier, my menstrual cycle began a week early. This has not happened in over 4 years.  NUMBNESS and LACK OF CIRCULATION - About one week after my second dose, my left arm became increasingly numb, beginning at the injection site and over 3 days, my entire arm felt an overall numbness. It felt like the numbness was beneath the skin, as I could feel when I touched my arm but did not feel the full sensation of pressure on my arm. Pain and numbness over my entire arm continued for 7-8 days following this.
Localized reaction to PPV 23 with large area erythema and pain to arm. Taken to ER by mother.
She got her vaccines, the right arm vaccine hurt, it was painful.  She was fine at home, both arms were sore from the shots.  Then she could not sleep at night, she tossed and turned and then got up for a while and was walking sideways like she was drunk.  She was scared as she was wanting to know if she was dying or not.  She would switch from the bed to the couch and her clothes were wet from perspiration.  She had no appetite Thursday or today.  She was disoriened, still not 100% but glad that she is alive.  She drove to the pharmacy today and pulled into the wrong parking lot and wrong business, and then went over the curb leaving the Pharmacy.  She took 2 Ibuprofen in the middle of the night which seemed to help.  She did not talk to her daughter, she just talked to the pharmacy who told her to contact us and report it.    She did have a reaction to the shingles vaccine, the 2nd one.
panic attack/anxiety/vomiting. took time to calm down 30minutes-1hr, resolved
After receiving the flu shot (FLUZONE) vaccination, the patient had swelling at the injection site 1 1/2" - 2" diameter
After injection 20 mins, got panic attack on freeway when driving.  one week after the vaccine still feel more nervous anxious than before. sometimes heart  racing  and no strength .
Date and time adverse event started: 4/6/21 immediately after receiving vaccine, caller reports feeling "cold sensation" in head and throughout body and then felt lightheaded. He did not report sx to vaccine staff and did not stay to be monitored for 15 min d/t someone thought they recognized him as a first responder and told him he didn't have to wait. Then when he left facility, he felt as if he was "hallucinating". States his truck was in park, but he felt like it was "rolling". Feeling subsided and he was able to drive home. He experienced night sweats for 2nights after injection.  Adverse events experienced and are they still occurring now:  yes, caller reports he still feels as if he is "hallucinating" when he wakes up from sleep; having very vivid dreams. He states the only other times he has experienced this is when he has been given narcotics for surgery
Swelling, redness, pain, warm to touch 8 cm Rt thigh.
N OTE:  On the date above, I recived the first in the series of vaccinations.  I received the second on 01/MAR/2021, and Boosters on 17NOV 21 and on 01MAY22.  The adverse event is a breakthrough case of COVID-19.  Day Zero on 27JUL 22.  On 30JUL22, I started a course of treatment with PAXLOVID.   the first day or two of infection caused symptoms consistent with a bad cold or flu, aches, extreme fatigue, runny nose, and chest congestion.  Those have been improving with each passing day.
Sore arm; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) 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 immunisation, reaction(s): "Tired", "sore arm"; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunisation, reaction(s): "Tired", "sore arm"; Bnt162b2;bnt162b2 omi ba.4-5 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "not body ache so much anything like that just it really tired/ Tiredness", "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Sore arm"; FATIGUE (non-serious), outcome "unknown", described as "Tired".  Additional information: Patient had all vaccines and all of then had been Pfizer and patient had no issues other than may be sore arm and been tired.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300352612 same patien, different dose/event;
has had all three doses and now he came back with a new variant of Covid; has had all three doses and now he came back with a new variant of Covid; 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 (BNT162B2) (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 was not reported. Concomitant medication(s) included: DEXAMETHASONE; PAXLOVID. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "has had all three doses and now he came back with a new variant of Covid". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: he came back with a new variant of covid. Clinical course: Caller then states he has had all three doses and now he came back with a new variant of Covid, states his doctor put him on this stuff. Caller states he is also taking another pill with Paxlovid which is called Dexamethasone, 6mg.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200125084 Same patient/vaccine, different vaccine dose/event
I had burning at the injection site 20 minutes after administration, but no concerns since I?ve had many vaccines before with no adverse reaction. At 35 minutes after the injection, I suddenly felt an intense deep aching pain in my left arm. Seconds after feeling the pain my heart fluttered. My palms and body began to sweat. The heart flutter made me stagger and feel off balance. I had another heart flutter. After that my vision closed in. I lost all depth perception. The next thing I knew I was on the floor. My wife caught me on my fall, so I didn't hit my head. She also called 911 and kept me talking to remain alert, but I was having a hard time focusing on anything but my breathing. When I became aware of my surroundings again, I had to concentrate hard on my breathing to remain conscious. My left arm all the way from my shoulder down to my fingertips was painful to the point of being unable to make a fist or support any of my body weight on it. The EMT/ ambulance showed up at 1:43pm. I was then transported to the emergency room, where I was checked in at 2:19pm. At 5:31pm I began getting what felt like a hot poker in my heart on the left side of my chest and some dizziness while sitting down. I was discharged at 7:30pm.  Since then, I have had one episode where I was standing and became as dizzy as when I first passed out. I got sweaty and my heart started racing, but I didn?t have any flutters. It eventually passed when I focused on my breathing. I have been extremely tired and unable to do any gentle activities, including standing and walking around the house without the potential of becoming lightheaded and dizzy.
This started Fri. with body aches. on sun cont. with  body aches , headache,  fever of 101.9, vomited, chills.  After 24 hours the fever broke and started to feel better.  still have headache and body aches.
Vaccine given by on site nurse  where pt works in medical records dept. No previous known reaction to flu shot. Pt sustained large local reaction R deltoid about 3" long with pain R upper arm.
Numbness in upper extremities and hands. Numbness and lack of power in hands and arms. Numbness and lack of power in legs oh my God I'm ready to get you medical testing laboratory results related to the
nauseous; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nauseous) in a 25-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. A57164B) for COVID-19 prophylaxis.     Crohn's - on Humira.  Previously administered products included for Product used for unknown indication: Influenza vaccine on 04-Oct-2022. Past adverse reactions to the above products included No adverse reaction with Influenza vaccine. Concurrent medical conditions included Crohn's (on Humira). Concomitant products included ADALIMUMAB (HUMIRA) for Crohn's.    On 04-Oct-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 04-Oct-2022, the patient experienced NAUSEA (nauseous). On 05-Oct-2022, NAUSEA (nauseous) had resolved.            It was reported that the patient was nauseous for hours after the shot. It started maybe 3 hours after the patient got it. After that the patient felt asleep and was fine the next day It is unknown if the patient experienced any additional symptoms/events. No treatment medication was provided.
Mother reported and showed pictures of diffuse intense, erythematous, urticarial  rash over baby's body. The rash started at the injection site about 1 day after the vaccination then spread to cover her body (sparing the face) over the next 2-3 days. Mom provided supportive care and did not seek medical consultation as the baby did not appear uncomfortable.  She presented for routine follow up at a clinic separate from the vaccinating clinic and asked for advice on future vaccines.
Patient is a 16 month old male who presented with pain with weight bearing on his right leg and difficulty walking first noted the day prior to admission.  He began having subjective fevers about five days ago (1 day after vaccination) associated with mild URI symptoms (which preceded the vaccination).  Of note, he received Hep A, MMR, varicella, and influenza vaccinations on 10/31 with the Hep A and varicella vaccines administered in the right thigh.  In the ED, inflammatory markers were elevated and MRI was notable for myositis, osteomyelitis and a soft tissue abscess in the right thigh.  He was admitted for IV antibiotics and remains admitted at the time of this submission.
?Janssen COVID-19 Vaccine?  Approximately 5 hours after recieving the vaccine I started feeling extremely tired and cold despite the climate being warmer than usual. I went to sleep and woke up shivering, i was cold but my body was burning to the touch. My body ached and I had a headache and nausea. My eyes hurt whenever I moved them. These symptoms persisted until 9:18, I took 2 tylenol pills and started feeling better. Today is my third day, my eye pain has not gone and I still feel tired but what is bothering the most is the eye pain whenever I look anywhere or move my head.