chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient held her stomach and needed to lie down for a few minutes but never passed out. She had not had anything to drink that morning.  She was given a juice and snack and accompanied to the car along with her mom.   Vaccine administration error by Nurse Practitioner: Patient's date of birth was not verified correctly and, at 10 years and 10 months old, she was given TDaP and MCV4 which was two months before she should have received them.  The HPV she was given was valid.  The CDC and the supervising MD were both consulted and it was determined that the patient will be fine but that the doses of TDaP and MCV4 would need to be repeated after 11 years old per the CDC. Mom was notified of the administration error and the steps taken to rectify the situation and of the need to repeat the vaccines.  The patient had no adverse reactions per mom.
Patient was supposed to given primary dose of COVID PFizer MonoValent .03mL but accidentally received PFizer Bivalent .03mL as her first dose. After patient received vaccine, patient stayed the required 15 minutes in case of any  reaction. The patient did not get no reaction to vaccine and was free to go after.
Noticed skin near original injection site felt itchy. Skin slightly below injection site was warm to touch with splotchy red hive ~3" diameter
High temp 103 and seizure: 9/11/04: went to ER. Second seizure since without fever.
Janssen COVID-19 Vaccine EUA  Muscle and joint aches, headache, Fever 100 degrees, lethargic, trouble sleeping
When she woke up this morning, she lost her voice; could barely talk; She has little cough; Her throat is sore; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (When she woke up this morning, she lost her voice), SPEECH DISORDER (could barely talk), COUGH (She has little cough) and OROPHARYNGEAL PAIN (Her throat is sore) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025B21A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced APHONIA (When she woke up this morning, she lost her voice), SPEECH DISORDER (could barely talk), COUGH (She has little cough) and OROPHARYNGEAL PAIN (Her throat is sore). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, APHONIA (When she woke up this morning, she lost her voice), SPEECH DISORDER (could barely talk), COUGH (She has little cough) and OROPHARYNGEAL PAIN (Her throat is sore) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medicine include Gabapentin, Muscle relaxer  Treatment medicine include Tylenol
I had a slight headache the day of the vaccine, and some soreness in my arm. I woke up the next morning after not being able to sleep all night with a temperature of 101.7 Fahrenheit coupled with profuse sweating and a stabbing headache. I took some Tylenol and drank a bunch of water and tried to go back to sleep ( Inhad woken up at 5:30). I was unsuccessful because I ended up having to vomit about 20 minutes later. Throughout the day, my temperature hovered between 99.5-100.4 even though I alternated Tylenol and ibuprofen. The symptoms persisted all day and I only started to feel relief around 7 pm. I feel fine today, but I still have a bit of a headache and my left arm is still sore.
pt recvd vax & devel meningitis d/t H. influenza type B (culture positive from blood);CSF obtained p/treatment started;obtained  quantitative immunoglobulins which are nl
6 days after vaccination, large, red, hot, itchy painful swelling on shoulder at vaccine site. Consistent with online reporting of "covid arm"
Sore arm with first COVID vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore arm with first COVID vaccine) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concurrent medical conditions included Rheumatoid arthritis (Moderate to severe rheumatoid arthritis). On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 1 dosage form. On an unknown date, ADALIMUMAB (HUMIRA) (Subcutaneous) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE PAIN (Sore arm with first COVID vaccine). At the time of the report, VACCINATION SITE PAIN (Sore arm with first COVID vaccine) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medication was reported. No treatment medication was reported. It was unknown if patient was enrolled in a COVID-19 vaccine trial. The reporter's causality for the event of sore arm with first COVID vaccine was not provided for Humira. 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. This case was linked to MOD-2022-629995 (Patient Link).
Patient is a 55 y.o. male with PMH significant for renal transplant, amyloidosis, hypertension, asthma and history of DVT who presented to the emergency department on 11/3/21 with chest pain.  He reports onset of symptoms last Tuesday with progressive cough and developed a fever on Thursday.  Has had poor orally intake but has tried to stay hydrated with water.  Has been having frequent diarrhea up to 6 times per day but only 2 episodes today.  Continues to intermittently feel feverish.  Denies any emesis.  He was seen by his PCP on 11/02 at which time he tested positive for COVID.   In the emergency department, VS remained stable on RA.  Labs notable for sodium 120, creatinine 2.49, eGFR 27. CXR showed airspace opacities within the right lung.  He was given monoclonal antibodies after which he began to feel more short of breath.  He was noted to be satting 88-90% and was placed on 2 L O2.  He was later able to be weaned back to room air.  Patient was admitted for ongoing management of hyponatremia.   Nephrology was consulted. GI symptoms essentially resolved by time of DC.  Na improved with fluids and was stable at 130 and Cr improved to 1.9 at time of DC.  Patient noted to have tremors and tacro trough level was high at 9 (goal 4-6) likely 2/2 COVID19 and diarrhea and so dose was temporarily decreased to 0.5/0.5 from 1/1 and patient reached out to his transplant team at time of DC and is arranging f/u trough level to be obtained (likely Monday).  He will f/u with PCP and need BMP rechecked in next 3-5 days.
Swollen lymph nodes in right armpit; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EW0162) via an unspecified route of administration in the right arm on 16Apr2021 at 14:15 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included isotretinoin (ACCUTANE); taken for unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8727) via an unspecified route of administration in the right arm on 26Mar2021 at 10:00 (at the age of 16-years-old) as a single dose for COVID-19 immunisation. On 17Apr2021 at 07:30, the patient experienced swollen lymph nodes in right armpit. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swollen lymph nodes in right armpit was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Called to room for throat complaint after Pfizer vaccine.   Pfizer vaccine had been given at 8:01.  Patient immediately c/o heart racing, metallic taste, and feeling that something's in her throat.   History of feeling poorly after flu vaccine and rash after TB skin test.  History of allergy to tomatoes and red dye.   VS: HR 86, BP 145/83, O2 sat 100% RA Gen: 33-year-old female appearing concerned Skin: warm and dry, no rashes HEENT: no rashes, no edema or erythema of face, mouth, or throat, Mallampati 1 Cardiac: RRR Resp: CTAB   8:06 Patient reports feeling the same in throat.  Starting to feel nauseous and "clammy" in left hand.   VS: HR 71, BP 118/78, O2 sat 98% RA Gen: 33-year-old female appearing concerned Skin: warm and dry, no rashes HEENT: no rashes, no edema or erythema of face, mouth, or throat, Mallampati 1 Cardiac: RRR Resp: CTAB Motor: B grip strength 5/5   Continued to monitor.  Patient's symptoms remained the same and HR remained in low 70s and O2 sats remained 98-100% RA   8:20 Patient began coughing and vomited a small amount.   VS: HR 90, BP 136/84, O2 sat 100% RA Gen: 33-year-old female appearing concerned Skin: warm and dry, no rashes HEENT: no rashes, no edema or erythema of face, mouth, or throat, Mallampati 1 Cardiac: RRR Resp: Wheezing in LLL   Code medic activated.  NP arrived to assist.  Patient assisted to exam table.   8:27 VS HR 90, BP 136/84, O2 sat 100% RA   8:28 Epipen 0.3 mg IM Left lateral thigh given   8:29 VS HR 81, BP 127/84, O2 sat 100% RA   8:31 Patient c/o throat tightness, chest tightness, sensation of cervical lymph node swelling   VS HR 78, O2 sat 100% RA Gen: 33-year-old female appearing concerned Skin: warm and dry, no rashes HEENT: no rashes, no edema or erythema of face, mouth, or throat, Mallampati 1 Cardiac: RRR Resp: Wheezing throughout   8:32 VS HR 75, BP 134/70, O2 sat 97% RA   8:33 VS HR 75, BP 134/7, O2 sat 99%   House Supervisor and two nurses from the ER arrived.  Report given.  Patient transported to the ER for further monitoring and treatment.     Report completed by LPN.  VAERS completed.  Work note sent.  Treated in ER with prednisone, Benadryl, and Zyrtec. Discharged home after 3.5 hours.
I woke this morning and couldn't get out of bed.; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 07May2021 (at the age of: 68-years-old) as dose 2, single for covid-19 immunisation and also received pregabalin (LYRICA, Lot Number: UNKNOWN), via unspecified route of administration, start and stop date, not reported for an unspecified indication. Medical history included bleeding problems from an unknown date and unknown if ongoing. She has done Flonase and Rhinocort clinical trials in the past. About 5 years ago she woke up with a nosebleed and the doctor said there was nothing they could do. They had to go up through my groin to stop it. Concomitant medication(s) included losartan potassium (COZAAR) and tramadol (TRAMADOL) taken for an unspecified indication, start and stop date were not reported. The patient was allergic to tetanus, naproxen, hydrocodone, Niaspan, Tylenol, HCTZ, morphine, Toprol and Flexidine. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration on 16Apr2021 (at the age of: 68-years-old) as dose 1, single for covid-19 immunisation it was reported that after receiving second dose she woke up the morning and could not get out of bed on an unspecified date. she was prescribed Lyrica because she had a history of bleeding problems, so she scared to take Lyrica. Outcome of the events was unknown.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Patient was at a vaccine clinic and completed the Pre-vaccination checklist  for Covid-19 vaccine and the patient answered  the question asking "Have you ever received a dose of Covid-19 vaccine" and was given dose number 1 of the Moderna vaccine. When I was entering the Moderna vaccine information in the program, I seen that the patient did receive the J & J vaccine on 04/28/2021 Lot # 202A21A Left Deltoid. Unable to reach patient, mailbox is full and unable to leave a message.
SHOULDER PAIN; BICEPS PAIN; INJECTION SITE TENDERNESS AND INJECTION SITE STINGING; PAIN IN BOTH ARM; This spontaneous report received from a patient concerned a 59 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: 043A21A expiry: UNKNOWN) dose was not reported, administered on 14-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On JUN-2021, the patient experienced pain in both arm. On 14-JUN-2021, the patient experienced injection site tenderness and injection site stinging. On 27-JUN-2021, the patient experienced shoulder pain. On 27-JUN-2021, the patient experienced biceps pain. Treatment medications (dates unspecified) included: ibuprofen. The action taken with covid-19 vaccine was not applicable. The patient recovered from injection site tenderness and injection site stinging on 15-JUN-2021, and had not recovered from shoulder pain, biceps pain, and pain in both arm. This report was non-serious.
I95.9 HYPOTENSION 5/20/2022 ASTHMA, UNSPECIFIED R57.9 SHOCK, UNSPECIFIED 5/20/2022 ASTHMA, UNSPECIFIED I95.9 HYPOTENSION 5/20/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE R57.9 SHOCK, UNSPECIFIED 5/20/2022 ATRIAL FIBRILLATION W RAPID VENTRICULAR RESPONSE I95.9 HYPOTENSION 5/20/2022 UTI (URINARY TRACT INFECTION) R57.9 SHOCK, UNSPECIFIED 5/20/2022 UTI (URINARY TRACT INFECTION) I95.9 HYPOTENSION 5/20/2022 ACUTE DVT OF RIGHT ARM R57.9 SHOCK, UNSPECIFIED 5/20/2022 ACUTE DVT OF RIGHT ARM
Patient states that she recently received her Johnson and Johnson covid vaccine on 4/8/21. After receiving the vaccine, she began experiencing right sided sciatica symptoms with painful sitting and ambulating. Did present to urgent care who evaluated and prescribed muscle relaxants. Today patient states that she is still very uncomfortable. Nighttime and using the bathroom (chair rise/sitting down) are the most painful. Symptoms discussed with PCP. Will continue prescribed Naproxen at this time and may also use tylenol. Should avoid any additional NSAIDS (ibuprofen, motrin). Rest and hydrate. Notified that we will check in with her on Thursday to see how she is progressing. Instructed to call wellness center sooner if symptoms are worsening.
legs are cold; she started getting a temperature of 101.3; chills; loss of appetite; This is a spontaneous report from a contactable consumer. A 83-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was TL9262 via an unspecified route of administration on 06Feb2021 at 14:20 in left arm (age at the time of vaccination was 83-year-old) as single dose for COVID-19 immunization. Medical history and Concomitant medications were not reported. The patient did not receive prior vaccinations within 4 weeks. On 07Feb2021, the patient experienced, she started getting a temperature of 101.3, chills, loss of appetite. On 10Feb2021, the patient experienced legs are cold. It was reported that caller stated her sister-in-law, had the vaccine on Saturday. On Sunday, she started getting a temperature of 101.3, chills, and loss of appetite and took an Advil or Tylenol. The next day she was much better, her temperature had gone down (99.4) and didn't have chills. However, she has a temperature again, it was 99.3 now. They both got the shot on Saturday. Both were fine. On Saturday her sister-in-law started getting a temperature and chills. She also had no appetite. She took a couple of Advil and Tylenol. The next day her temperature went down from 101 to 99.4 degrees. She had temperature for two days. She slept good. Today her legs are cold. She does take any other medications. Patient underwent lab test and procedure which included Body temperature 99.4 gone down on unspecified date, Body temperature 99.3 on unspecified date, Body temperature 101.3 07Feb2021. Outcome of events she started getting a temperature of 101.3 and chills was recovering, while outcome of loss of appetite was recovered on 08Feb2021 and of legs are cold was unknown.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
an eight year old patient received Flublok Quadrivalent with no AE; Initial information received on 14-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves an eight year old female patient who received a dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] lot, expiry date: unknown via unknown route on 10-Oct-2019.  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the vaccine administered to patient of inappropriate age.  It was not reported whether the patient experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on batch number requested
second dose 35 days apart; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a female patient who received Herpes zoster (Shingrix) (batch number G4py5, expiry date unknown) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 6th January 2022, the patient received the 2nd dose of Shingrix. On 6th January 2022, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were reported as follows: Age at vaccination was not reported. The patient received a dose of Shingrix on 1st December 2021 and second dose 35 days later on 6th Jan 2022 which led to shortening of vaccination schedule. Consent to follow up was granted.
Crying, cannot sit up, cerebellar ataxia 5 hrs after vaccine admin, resolved.
Developed hives/urticarial rash approximately 3 hours after vaccine.  No other know precipitants for urticaral rash.  Patient continued to have symptoms for 2 days.  Today still with few hives but not as prominent as on the first 2 days.  Patient has been using Bendaryl 25 mg q 4 hrs scheduled since the hives began.
Large red and swollen rash as well as a line of red bumps next to rash that showed up 8 days after injection
This spontaneous case, initially received on 03-Oct-2018 from a other non-health professional, concerning a 21-year-old, adult, female patient. The patient had no medical history and the concomitant medications were not reported. The patient believed he was not allergic to latex. The patient also did not have any coagulation issues (for which he was tested). On an unspecified date in 2017 (last year as reported), the patient was administered with FLUAD (TIV) [dose: 0.5ml, batch number: 178323, route of administration, anatomical location, and expiry date: not reported]. On an unspecified date, after vaccination, the patient developed bruising from shoulder to elbow and a red circular spot. It took 6 months for bruise to resolve and the patient talked to doctor to make sure it wasn't an allergic reaction. The patient told that it could have been some allergy and the patient was not sure that he was allergic to latex. The patient believed that was not an adverse event from the vaccine but probably the person who administered hit a vein or something and as an elderly patient he had more susceptibility to get bruises. At the time of this report, the patient had recovered from the event (bruising of arm) and the outcome of the events (redness and allergic reaction) was not reported. The reporter assessed the case as non-serious.
Woke up at 6{00 am the next morning with a left swollen cheek, swollen tongue and a left stiff neck. I took half of a Zytec antihistamine, one Advil and drank extra water. Applied an ice pack. Stiff neck stopped at 36 hours. Swollen tongue stopped at 48 hours. Left cheek swelling went down by 50 % at 72 hours.
Patient states: Sore arm, bruised, red area around injection site, swollen, pain that travels to upper shoulder.
Multiple nodules appear on skin on and around scrotum and groin area. Treated with anti-biotics and steroid cream for 1 week with only worsening symptoms. Followed by 2 weeks of antihistamine and steroid cream with no improvement.
sore arm after the first 6-8 hours that lasted maybe 8 hours.  At approx. 30 hours post vaccination, woke with fever, chills, rigors; took Tylenol and Benadryl and symptoms subsided after about 3 hours.
This case was reported by a non-health professional via other manufacturer and described the occurrence of allergy to vaccine in a adult female patient who received Influenza vaccine Quadrivalent unspecified season for prophylaxis. Concurrent medical conditions included vitamin d deficiency, anemia, depression, migraine, hypothyroidism and drug allergy (AMOXIL, Tramadol and BENADRYL). On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergy to vaccine. On an unknown date, the outcome of the allergy to vaccine was unknown. It was unknown if the reporter considered the allergy to vaccine to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at vaccination was not reported. The patient was 20 years old at the time of reporting. In December 2017, the patient received COSENTYX (150 mg) subcutaneously once a month for ankylosing spondylitis of unspecified sites in spine. The patient reported not taking COSENTYX for three weeks due possible blood clots after being involved in a car accident. No further information was given. The patient reported in confidence and did not give consent to be contacted. The patient did not give consent for healthcare professional contact.
The night after I got the flu shot, I had itching on my upper arm, near where the shot was given. The next morning, I woke up with a large itchy hive on my upper arm.  During the day the hive went away - I did not want to take any Benadryl because I had to drive.  That evening the hive and the itching returned and I took Benadryl and it went away.
Fever, chills, dizziness, vomiting, s/p injection. Has tenderness at injection site but no swelling. Encouraged hydration, rest, bland diet, acetaminophen as needed for fever/pain.