chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No Adverse Event; They gave the patient a bivalent booster today 23Dec2022, but he already received it a month ago on unknown date/getting two doses of the bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (They gave the patient a bivalent booster today 23Dec2022, but he already received it a month ago on unknown date/getting two doses of the bivalent booster) and NO ADVERSE EVENT (No Adverse Event) in a 62-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On 23-Dec-2022,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXTRA DOSE ADMINISTERED (They gave the patient a bivalent booster today 23Dec2022, but he already received it a month ago on unknown date/getting two doses of the bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXTRA DOSE ADMINISTERED (They gave the patient a bivalent booster today 23Dec2022, but he already received it a month ago on unknown date/getting two doses of the bivalent booster) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (They gave the patient a bivalent booster today 23Dec2022, but he already received it a month ago on unknown date/getting two doses of the bivalent booster).    No concomitant medications were reported. The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Information about previous COVID-19 vaccination was unknown. They were wondering if there were any concerns that the patient should be expecting from getting two doses of the bivalent booster. Treatment information was not provided.
First shot: VERY painful around 1:30am next morning. Whole left arm to fingers. Couldn't sleep.....took 400mg Ibuprofen. Got back to sleep around 5:30am and woke at 9am feeling perfectly fine! Ouch it was painful.  Second shot: Taken yesterday at 1:00pm. Difficult and painful night. Got worse around 2am. Whole body in pain! Dizzy, ears ache, dry mouth, difficulty urinating, slow, Slept on an off. Could not sleep on painful left arm (from shot). I stayed in bed until 9;15am. Feeling MUCH better. Lousy night! Sent email earlier to Dr. for suggestion on an aspirin or antidote.  Now this form.....I had hoped for suggestions. Where's the help?
On 1NOV pt recvd vax & same day leg swelled @ site to 1/2 orange; 8NOV94 testicles swolled to walnut size; this lasted 3 days; seen by MD stated react to MMR vax; tx w/warm baths subsided p/3 days;
Pt reports a history of eczema since childhood. He states that every winter he has eczema on his arms, legs, and trunk and controls it with a humidifier in his home and the use of Eucerin cream and lotions. He states that his eczema clears in the spring when he no longer has to heat his home. Rash had cleared for this year.    04 Apr 04 he received anthrax # 1: approx 8 days later he noticed red marks in the folds of his arms and neck. Area on his neck was from his chin to his chest and was 3-4 inches across the front of his neck. He used lotion, which helped. He stated he noticed a lot of itching on his neck. Pt reported that he never had eczema on his neck before and was not sure if this redness on his neck was even eczema as it was unlike his previous eczema flares. States the area was almost cleared when he got his second anthrax.  28 Apr 04 he received anthrax #2: one week later he reported eczema on every finger from his knuckle to the tip of his finger and on his rt arm extensor surface near his elbow. He has never had lesions in these areas before.  By 12 May all lesions have cleared completely.  Follow up call on 13 Jan 05 post deployment: No further outbreaks other than his usual winter outbreaks.
The patient received the Tdap immunization without complications on Friday, March 6, 2009.  Pt stated she felt fine with no problems until Wednesday, March 11, 2009 when she noted redness, swelling and warmth at the injection site (Left deltoid).  Pt was seen for a pre-operative appointment on 3/13/09 and started on Bactrim DS 1 tab PO BID for cellulitis sx of her left arm.  Pt stated sx completely dissipated and she is feeling fine with no further problems.
Large itchy red raised painful rash around injection site and going toward inner upper arm.  Size was about 7 inches.   Lasted 5-6 days.  Used ice and Benadryl.
first dose of Shingrix on 5-24-18 / unable to receive the second dose because of shortage; This case was reported by a consumer via and described the occurrence of product supply issue in a 54-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 24th May 2018.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced product supply issue. On an unknown date, the outcome of the product supply issue was unknown.  Additional details were provided as follow: This case was reported by the patient itself. The age at vaccination was not applicable for this report. Till the time of reporting, the patient was unable to receive the second dose because of the shortage, which led to product supply issue. The patient asked could he/she get the 2nd dose or was it too late, and do he/she need to restart the series. No further information was provided.
Undue pain and swelling and redness of left arm, which is presently resolving, but not completely gone.
Patient was sitting down for a few minutes after their vaccine and then got up to tell the pharmacy staff he wasn't feeling well. He walked back to the waiting room and fell onto the bench. I went out to sit with him and held onto him as he passed out/lost consciousness for approximately 20 seconds. We gave him water and called 911. The paramedics arrived and checked his vitals. He was fine after that and stayed for about a half an hour before he left.
Initial misuse report received from a healthcare professional on 16 September 2013. Some patients (no information was provided regarding the patients) had received a dose of FLUZONE on an unspecified date. It was reported that last week, the fridge went at 55F for 5 hrs and the patients received doses from O/E vials. No adverse event was reported. List of documents held by sender: none.
Pt recvd vax & devel angioedema following Hep B vax 16MAR92;
and in that facility they gave him another shot of the Moderna Covid19 Vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (and in that facility they gave him another shot of the Moderna Covid19 Vaccine.) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A, 025J20A and 026L20A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia (He had dementia since before the Moderna Covid19 Vaccine.).   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (and in that facility they gave him another shot of the Moderna Covid19 Vaccine.). On 25-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (and in that facility they gave him another shot of the Moderna Covid19 Vaccine.) had resolved.            Concomitant medications were not provided by reporter. It was reported that, after 2 doses, patient went to primary facility for a foot exam, when asked for the reason of the foot exam was because he needed a pedicure. Treatment information were not provided by reporter.
lymph node swelling, painful injection arm, fatigue Narrative:  Other Relevant History:
Arm is just so itchy; This is a spontaneous report from a contactable consumer, the patient. A 25-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: en6208), via an unspecified route of administration in the arm left on 19Mar2021 at 16:00(at the age of 26-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma, endometriosis, cystitis interstitial and immune thrombocytopenic purpura (ITP) from an unknown date. The patient was allergic to banana, pineapple, latex and prednisone. Concomitant medications included cetirizine hydrochloride (ZYRTEC), levonorgestrel (KYLEENA), AFFAIR and SINGULAR started on an unknown date for an unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 19Mar2021 at 19:00, the patient's arm was just so itchy, even 4-5 days later. There was no redness. It was not even warm. But the inside of patient arm itches so badly. The patient did not receive any treatment for the event. The adverse event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event arm just so itchy was resolving. The patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0151), via an unspecified route of administration in the arm left on 02Apr2021, as a single dose for COVID-19 immunisation.  No follow-up attempts are needed. No further information is expected.
I developed dermatographia about 12 days after the Moderna booster. I still have it and it is showing no signs of going away. I get itchy raised welts whenever and wherever something puts pressure on my skin (scratching, rubbing, etc). There is no cure or treatment other than antihistamines, which do not usually work.  This condition may last years and may even be permanent.
This spontaneous report as received from a physician assistant refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On 16-SEP-2013 the patient was vaccinated with a dose of PNEUMOVAX23 lot # H017801 (expiry date: 09-JUL-2014), 0.5 ml, intramuscular. No concomitant medications were reported. The physician assistant reported that the physician informed the physician assistant, that the patient developed an unspecified rash (on 16-SEP-2013) after receiving PNEUMOVAX23. The physician had requested information on the solvent used for PNEUMOVAX23. The outcome of the unspecified rash was unknown. No reporter causality was provided. Additional information has been requested.
Patient said a sore throat started Tuesday night (night after vaccination) and lasted less than a day. She also developed a cough around the same time that lasted one week.
injection site is extremely hot; is not feeling well; injection site is extremely red; injection site is now about the size of a baseball; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site is extremely hot), VACCINATION SITE ERYTHEMA (injection site is extremely red), VACCINATION SITE SWELLING (injection site is now about the size of a baseball) and MALAISE (is not feeling well) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Nov-2021, the patient experienced VACCINATION SITE WARMTH (injection site is extremely hot), VACCINATION SITE ERYTHEMA (injection site is extremely red), VACCINATION SITE SWELLING (injection site is now about the size of a baseball) and MALAISE (is not feeling well). At the time of the report, VACCINATION SITE WARMTH (injection site is extremely hot), VACCINATION SITE ERYTHEMA (injection site is extremely red), VACCINATION SITE SWELLING (injection site is now about the size of a baseball) and MALAISE (is not feeling well) outcome was unknown.            No concomitant medications provided. No treatment medications provided.
passed out; twitching; Gasping for air on the ground for less than a minute.; This is a spontaneous report received from a contactable consumer or other non hcp. A 44-years-old male patient received the second dose of bnt162b2 (COMIRNATY,Batch/Lot Number: Ew0168), via an unspecified route of administration, administered in Arm Left on 27May2021 09:00 as a single dose, and dose 1 via an unspecified route of administration, administered in Arm Right on 06May2021 09:15 (Batch/Lot Number: Ew0171) as a single dose for COVID-19 immunization . Medical history included blood cholesterol increased from an unknown date and unknown if ongoing and High cholesterol and triglycerides , blood triglycerides increased from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On the third day after the second shot the patient did some yard work and then after coming inside passed out and was twitching and gasping for air on the ground for less than a minute. I then sat up took some juice and was fine. The patient experienced passed out (loss of consciousness) , twitching (muscle twitching) and gasping for air on the ground for less than a minute (dyspnoea). patient underwent lab tests and procedures which included blood cholesterol: high on High cholesterol and triglycerides , blood pressure measurement: fine and blood triglycerides. Prior and since the vaccination, patient was not tested for COVID-19. The patient didn't take any other vaccines 4 weeks before the COVID vaccine.   The patient took the covid19 vaccine in hospital. Device date reported to be 11Jul2021.  Follow-up actions are needed. Further information has been requested.  Follow-Up (16Jul2021): Follow-up attempts are completed. No further information is expected.
Fever.   Cough.  Chest and nasal congestion.  Tachycardia.  Diaphoresis when sleeping.   Neuropathy.   Tremors and incessant shaking at night.  Headache.   Body aches.
No additional adverse event; Inbound call from HCP stating that a improperly store PEDVAX that experienced a supported excursion was administered to a patient. No additional AE details or PQC.          ?    Names of vaccines involved (including lot/exp) PEDVAX HIB U031544 Jun; This spontaneous report has been received from a nurse, regarding to a patient of unknown gender and age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and previous drug reactions or allergies were not reported.   On 31-OCT-2022, the patient was vaccinated with improperly storage dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) intramuscular Injection (lot number: U031544, which was determined to be valid, with an expiration date on 23-JUN-2024) administered as prophylaxis (strength, dose, route of administration, and anatomical site of injection were not reported).   Administered doses were stored at a temperature of 33 degrees Fahrenheit (F) during a time frame of 9 minutes. There was no previous temperature excursion.  No additional adverse events were reported in the patient.
Patient is a previously healthy 16 year old male who presented to ER for severe substernal chest pain. Patients states that at 1 pm he started to experience 4-5/10 substernal chest pain. He spoke to his sister who suggested he rest and drink a glass of milk. Patient states that he tried a hot shower which helped a little but by 9 pm the chest pain increased in severity to 8-9/10. He denies fever, SOB, dizziness, palpitations, N/V. He called his bother who brought him to the ER. History significant for receiving second Pfizer COVID vaccine 3 days prior. Labs at outside ER were significant for high sensitivity Troponin elevated to 1447, CK = 1342, CRP= 2.89. EKG demonstrated ST elevation in anterior inferior leads as well as lateral precordial leads. Electrolytes, CBC wnl, LFTs mildly elevated AST at 88. Echo reported to be normal function and intracardiac structure. His was afebrile with a HR of 81, RR =20, BP= 173/91 decreased to 112/66 after falling asleep, Oxygen Sats =100%..  16 year old previously healthy, 16 year old male who present with substernal chest pain in the setting of second dose of Pfizer COVID vaccine 3 days ago. Lab work and EKG consistent with post Vaccine myocarditis/pericarditis. Patient has no hemodynamic compromise requiring only pain relief for chest pain. No respiratory distress. PICU admission for monitoring for cardiac arrhythmias, pain management, serial EKGs and trending of his elevated troponin and inflammatory markers.
Massive Pulmonary Emboli from DVT in right calf. Near death reaction had a Thrombectomy on Aug 23, 2021 at Hospital.
Nine hours after shot, heart rate accelerated. I held breath repeatedly to slow heart rate, then about fifteen minutes later would accelerate again. I repeated treatment and finally after about two hours heart rate returned to normal permanently.
A report was received from a health care professional on 11/14/03, concerning a 51 year old male vaccinee who inadvertently received expired Fluvirin SC on 11/11/03. On 11/11/03, the vaccinee inadvertently received expired Fluvirin SC. The vaccinee did not experience any adverse events at the time of the report. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Patient developed arthralgias, change in mental status. Diagnosed with Systemic Lupus Erythematous on 10/23, based on +ANA and +dsDNA. Admitted to Hospital for changes in mental status, thought to be from lupus cerebritis. records received 11/14/08-presented to ED 10/28/08-C/O short term retrograde amnesia. Intermittent blurry vision. C/O joint pain, headaches nausea for 4 weeks. Left hand weakness. One and half months prior C/O pain in hands and feet, isolated papules. Difficulty sleeping.    12/1/08-DC summary received for DOS 10/28-11/6/08-DX:Lupus cerebritis. Change in mental status.
Patient states 6 hours after receiving second dose of Moderna COVID19 vaccine she got very lightheaded and dizzy. She started getting heart palpitations and called 911. She went to the ER and they gave her a SL tablet. She then was very tired and slept. She felt better the next morning and has been feeling better since.
This case was reported by a pharmacist via call center representative and described the occurrence of numbness in fingers in a 85-year-old female patient who received SHINGRIX (batch number 9AS39, expiry date 13th July 2020) and (batch number A4X57, expiry date 13th July 2020) for prophylaxis. On 11th May 2018 12:21, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, the dose was an unknown dose. On 12th May 2018, 1 days after receiving SHINGRIX, the patient experienced numbness in fingers and skin discoloration. On an unknown date, the outcome of the numbness in fingers was not recovered/not resolved and the outcome of the skin discoloration was recovering/resolving. The reporter considered the numbness in fingers and skin discoloration to be probably related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but could be 84 years or 85 years. The patient received SHINGRIX in the left deltoid. The reporter did not have the lot number from the box but provided the lot numbers from both the antigen (9AS39) and the adjuvant (A4X57) vials. One finger on the patient's left hand was numb and another on the same hand turned black and blue.
Patient arrived at Immunizations clinic to receive vaccines. HM administered the Gardasil vaccine in his right deltoid and Yellow Fever left arm around 1458 to 1500. Seconds after receiving vaccines, Pt stated he was feeling very warm and began sweating, flush, pale, and requested water. Pt transported from chair to exam table with feet elevated. Pt drank water and stated he was feeling better and proceeded and to sit in chair after only 2-3 minutes. While monitoring Pt in chair he suddenly became non responsive to verbal command.  Skin looked pale, diaphoretic and had choking like symptoms, mouth clinched, cheeks puffy, head back with stiff neck. Also noted Pt began urinating, and jerking movement with making groggy sounds to indicate still breathing.
This was the patient's third dose on 05/27/2021. When home visiting RN gave first dose on 04/26/2021, the patient marked 'No' to 'Have you ever received a dose of COVID-19 vaccine?'.  No adverse reaction was noted to patient during 15 min post-vaccine observation. Actual first dose was given on 02/05/2021.
On the evening of the shots, she developed low grade temp that increased the following day to 104F. She also developed emesis (NBNB) x 3 with last emesis this morning at 11 am. No diarrhea. No abdominal pain. Slight soreness at site of vaccines but no appreciated swelling or redness. She had temp to 100.5F at our office today. no sore throat, no URI symptoms.
First dose / on 2019 and the second dose has not been administered yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (received 1st dose in 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: Age at vaccination was not applicable for this report. The pharmacist informed that the patient received the first dose of Shingrix on 2019 and the second dose was not administered till the time of reporting which led to incomplete course of vaccination.  The reporter did not consent to follow-up The reporter did not provide patient's identifiers nor vaccine lot number and expiration date.
Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Mild, Systemic: Weakness-Medium, Additional Details: 1:19PM: Pt expressed anxiety, received vaccination, c/o of panic attack and sad down by the chair. 3 secs later, looked flaccid, unresponsive, discolorized, jerked breafly, bladder incontinent, loud sound, no difficulty breathing, no allergic reaction. RPH open airway, layed on side, head raised and called 911. Pt immediated had a deep breath and became responsive, alert/oriented x3. Ambulance, SaO2 97%.Pt later didn't see the need to urgent care, husband insisted, transported out by ambulance.
PATIENT STATES 2 DAYS AFTER RECEIVING THE VACCINE HE STARTED TO EXERPERIENCE UTICARIA ON BOTH ARMS AND BACK. HE SELF TREATED WITH DIPHENHYDRAMINE 25 MG EVERY 4 TO 6 HOURS AND REPORTS THIS HAS HELPED TO IMPROVE THE ITCHING.
pt admitted to hosp and diagnosed with bilateral COVID pneumonia with respiratory failure; treated with remdesivir and Plavix; 15 L O2 on heated high flow; pt coded and was intubated; bradycardic then asystolte; pt pronounced dead in the hospital; acute on chronic hypoxia and respiratory failure due to COVID