chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID Vaccine Breakthrough Trough  Pfizer Dose 1 4/8/21 (ER8737) Pfizer Dose 2 4/30/21 (ER8734) COVID Positive 12/1/21  12/6/21: Patient is a 70-year-old female history of chronic COPD, vaccinated against COVID-19 diagnosis with COVID-19 on December 1, 2021 presents to ER with chief complaint of generalized weakness associated with poor p.o. intake, nausea vomiting and diarrhea for the past few days. Evaluations completed the emergency room noted for hypoxia requiring 15 L of high-flow oxygen, chest x-ray demonstrated pneumonia, blood work noted for acute kidney injury, perfusion scan low probability for Regulatory Authority, patient was treated with IV fluid, Decadron, empiric IV antibiotics.  12/15/21: Patient was given steroids, antimicrobials, VTE ppx, O2 supplementation which was weaned down on the day of discharge. She continuously shows signs of improvement towards the day of discharge. Pulmonology was consulted. Patient will require 3L oxygen via nasal cannula with activity. Pt discharged home in stable conditions on a steroid caper course
Psychosis  was found  walking   at two-thirty  in the  morning  I    had left  my apartment
I was sick with body aches, fever, sleepy, weak, headaches, the first shot was worse. Started feeling change in arm within 20 min of the first shot with symptoms lasting 48 hours. Second shot symptoms didn't start until the next morning and I had nausea and hive on my arm, still have some symptoms Monday.
Pt devel pain, edema, pruritus, erythma, induration, & warmth @ inject site; edema was approx 5" in diameter;
The patient began to vomit within 10 minutes of receiving his vaccine . He was also having numbness in his left hand.  I sat with the patient in the consultation room for 20 minutes, until he became more calm. I offered him some water and I took his blood pressure every 5 minutes.  It was initially 154/105 and eventually decreased to 140/90. His heart rate was normal and he had no shortness of breath or signs of any rash. He threw up twice.  I offered to call ems for him if he wanted  but he declined. Once his blood pressure decreased he said that he felt better and sat in the pharmacy waiting area until he felt completely better. I called him 30 minutes after his departure from the pharmacy to make sure he got home safe and he was thankful for the call. I did advise him to contact his PCP if the numbness in his hand worsens or does not get better. I also told him to seek medical help if he gets any shortness of breath, rash or other unusual symptoms.
Second hot reaction on the left side of her face; Very sore arm like never before; Headache; Hot flash in the entire body lasted 5 seconds; Had to make myself breath; Sleep apnea; Felt hot in the face and cheeks; Anxiety; Trouble sleeping; This spontaneous case was reported by a nurse and describes the occurrence of HOT FLUSH (Hot flash in the entire body lasted 5 seconds), PAIN IN EXTREMITY (Very sore arm like never before), DYSPNOEA (Had to make myself breath), SLEEP APNOEA SYNDROME (Sleep apnea) and FEELING HOT (Felt hot in the face and cheeks) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Exercise induced asthma and Sleep apnea.    On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced HOT FLUSH (Hot flash in the entire body lasted 5 seconds), PAIN IN EXTREMITY (Very sore arm like never before), DYSPNOEA (Had to make myself breath), SLEEP APNOEA SYNDROME (Sleep apnea), FEELING HOT (Felt hot in the face and cheeks) and HEADACHE (Headache). On 08-Jan-2021, the patient experienced FEELING HOT (Second hot reaction on the left side of her face). In January 2021, the patient experienced INSOMNIA (Trouble sleeping) and ANXIETY (Anxiety). On 06-Jan-2021, HOT FLUSH (Hot flash in the entire body lasted 5 seconds), DYSPNOEA (Had to make myself breath), SLEEP APNOEA SYNDROME (Sleep apnea) and FEELING HOT (Felt hot in the face and cheeks) had resolved. On 07-Jan-2021, PAIN IN EXTREMITY (Very sore arm like never before) had resolved. On 08-Jan-2021, FEELING HOT (Second hot reaction on the left side of her face) and HEADACHE (Headache) had resolved. At the time of the report, INSOMNIA (Trouble sleeping) and ANXIETY (Anxiety) outcome was unknown.        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 product use was not provided by reporter. Treatment for the event of trouble sleeping was antihistamine NOS.
Within 1/2 hour of vaccination the patient was dizzy and was having a hard time remaining upright, additionally the patient was less alert and oriented. Patient was observed for a few minutes and then ambulance was called. Patient was transported via EMS within an hour of being vaccinated to local hospital. Patient was found to have has had major stroke and is presently in ICU and not expected to make it.
This spontaneous report as received from a healthcare worker (medical assistant) refers to a patient of unknown age and gender. It was reported that a medication error occurred on an unspecified date due to product confusion described as "GARDASIL (lot # L035105, expiration date 14-MAY-2017) was used to reconstitute an M-M-R II (lot # L039551, expiration date 07-OCT-2017), 1 vial each and 0.5 ml was intramuscularly administered to the patient once". No adverse effects reported. Additional information has been requested.
Information has been received from a health care worker concerning a 15 month old patient who was vaccinated with a first dose of VARIVAX on an unspecified date. The patient got chickenpox after getting VARIVAX. Unspecified medical attention sought. The patient's outcome was unknown. Medical attention sought. Additional information has been requested.
On the day of vaccination I had cold symptoms, with a slight sore throat without nasal congestion, fever or headaches. After the vaccination I went back home and spend the night without problems. Upon awakening the next morning, I had chills and general weakness, and suspected that I had a fever. My heart rate was abnormal and felt like skipping beats when taking my pulse, at a rate of perhaps one every 20 seconds. This was alarming so I presented myself to urgent care. They measured my temperature at >38 degrees C with heart PVC on ECG. I was sent home for rest and recovered after a few days.
After receiving vaccination, patient unable to lift L arm. Was evaluated by MD and diagnosed with L deltoid myositis after injection. Patient reports she was prescribed antibiotic, anti-inflammatory and physical therapy.
70 year old patient received Bexsero series; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 70-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   The patient's past medical history included lymphadenectomy.   In January 2020, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. In January 2020, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The Bexsero vaccine approved for use in individuals aged 10 through 25 years however 70 year old patient received Bexsero series, which led to inappropriate age at vaccine administration. The patient had a lymphadenectomy and would like data on a booster. The reporter planned on administering the booster dose, which led to extra dose administered and circumstance or information capable of leading to medication error. No reactions were reported. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter.  Follow up information received from physician on12th March 2021: The reporter received follow up letter and had questions about adverse event but had no information to provide.  GSK Receipt Date: 12-MAR-2021 Case update: The event circumstance or information capable of leading to medication error and extra dose administered was deleted from case and narrative updated.
received full schedule but has no detectable titer; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis, HBV (Engerix B) for prophylaxis and HBV (Engerix B) for prophylaxis.   Concurrent medical conditions included dialysis.   On an unknown date, the patient received the 1st dose of Engerix B, the 2nd dose of Engerix B, the 3rd dose of Engerix B and the 4th dose of Engerix B. On an unknown date, unknown after receiving Engerix B, Engerix B, Engerix B and Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The pharmacist said that, no other details of patient and vaccine was available. The pharmacist reported that, the patient on dialysis received full schedule, all 4 doses of Engerix-B but had no detectable titer.  The reporter would like to know if there was a booster shot for Engerix-B. The pharmacist did not consent to follow-up.
*Patient was being observed in the patient waiting area post injection given at 11:00am. Had to wait 30 minutes due to prior reaction to MMR in December of 2020. At 20-25 minutes post injection patient started itching with arms and chest becoming red. Nurse and NP observing came over to patient and assessed. They administered Benadryl 25mg due to itching and redness. Advised patient to go home and also take Pepcid to help the Benadryl. Patient drove home immediately and by 12:00pm after looking in mirror lips and lower arms minimally swollen. Patient took another 25mg of Benadryl. No change, skin continues to break out and itch. Right lower forearm begins to swell more. Patient takes a third Benadryl 25mg along with a Prednisone 20mg PO.  After the 75mf of Benadryl total and Prednisone 20mg the reaction gradually subsides, but does not go away 100%. It is manageable at this time.  *Overnight the patient develops dizziness and headache.  *By morning (07:00am on 04/16/2021) the patient is itching minimally, dizzy, has headache, nauseated, and now is experiencing vertigo with what feels like equilibrium imbalance. Patient stays home from work and rests all day. No fever, no SOB, and no other signs at this time.  *Patient continues to show the above signs through Monday, April 19, 2021 with now on Tuesday April 20, 2021 additional signs of night sweats, muscle cramps, and soreness in her legs.
The day after receiving my Pfizer vaccine, I woke up and felt fine with just a sore arm. After some light activity, my heart rate spiked. I noticed it on my fit bit and counted myself and it went up to 140-142 beats per minute. I could hear my heart pounding really hard and fast and could hear it in my ears. After I sat down, it didn't really go away and remained at around 120 at rest. This also happened with my 3rd dose of a COVID-19 vaccine, but it was Moderna brand. The day after the 3rd dose, my heart rate was elevated even at rest. So, I decided to go to the emergency room to have it checked out this time. My main symptoms were fatigue, and this elevated heart rate issue. They did an EKG and gave me fluids and then monitored me for a few hours. They said the EKG was fine, so they sent me home. My heart rate was relatively high for the rest of the day at around 100 beats per minute, but it has been getting back to normal over the past few days.
gets the injection, there is light redness, almost pink, at the injection site; Initial information received on 19-Oct-2023 regarding an unsolicited valid non-serious case received from a patient.  This case involves an unknown age female patient for whom there is light redness, almost pink, at the injection site after receiving Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included varicella zoster vaccine rge (CHO) (Shingrix) for Immunisation.  On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (strength, formulation, batch number, expiry date unknown) via unknown route in unknown administration site for flu (Influenza).  On an unknown date the patient had light redness, almost pink, at the injection site (vaccination site erythema) (unknown latency) following the administration of influenza vaccine.  Reportedly, the caller mentioned that she was preparing to get the Flu Vaccine for people aged 65 and older, and she usually received the injection. She had noticed that each time she got the injection, there was light redness, almost pink, at the injection site. Additionally, each year the redness appeared to be larger than the previous year. Two years ago, it was the size of a 50-cent coin, and the year after it was a bit larger than that. She also observed a similar effect with a different vaccine called Shingrix. She would like to know if it is safe for her to proceed with the Fluzone Vaccine shot and whether this is a normal effect.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (gets the injection, there is light redness, almost pink, at the injection site).  At time of reporting, the outcome was Unknown for the event gets the injection, there is light redness, almost pink, at the injection site.
Developed elevated bilirubin; This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age and gender received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown), via an unspecified route of administration on unspecified date as dose number unknown, single for covid-19 immunisation. Medical history included breast cancer metastatic from an unknown date and unknown if ongoing, gilbert's syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced developed elevated bilirubin on an unspecified date.  The patient underwent lab tests and procedures which included blood bilirubin increased: increased   on unspecified date. The clinical outcome of the event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021470248  same reporter/drug/AE, different patients(2nd of 3 patients)
COVID 19 Treatment; COVID 19 Treatment; Vaccine brand Other: Jansen/Vaccine brand Other: Moderna/Vaccine brand: Pfizer / BioNTech/Vaccine brand Other: Moderna biv; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 20Aug2022 as dose 3 (booster), single (Lot number: FP7150) at the age of 58 years, in right arm for covid-19 immunisation; coviD-19 vaccine nrvv ad26 (jnj 78436735) (COVID-19 VACCINE JANSSEN), on 08Apr2021 as dose 1, single (Lot number: 042A21A), in right arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 05Nov2021 as dose 2 (booster), single (Lot number: 021C21A), in right arm for covid-19 immunisation; coviD-19 vaccine nrvv MVa (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), on 06Dec2022 as dose 4 (booster), single (Lot number: 023H22A), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergies" (unspecified if ongoing), notes: Other medical history: Allergies & asthma; "Asthma" (unspecified if ongoing), notes: Other medical history: Allergies & asthma. Concomitant medication(s) included: FLONASE [FLUTICASONE PROPIONATE], start date: 01Jan2022, stop date: 03Jan2023; ASTEPRO, start date: 01Jan2022, stop date: 03Jan2023; ALLEGRA [FEXOFENADINE HYDROCHLORIDE] taken for hypersensitivity, start date: 01Jan2022, stop date: 03Jan2023. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 20Aug2022, outcome "unknown", described as "Vaccine brand Other: Jansen/Vaccine brand Other: Moderna/Vaccine brand: Pfizer / BioNTech/Vaccine brand Other: Moderna biv"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: It was reported that patient received Paxlovid treatment for Covid-19 from 13Dec2022 to 17Dec2022. Reported that patient received other medication in 2 weeks. No Known allergies.
extremely ill/horribly ill; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (201253). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "covid" (unspecified if ongoing), notes: Having Covid three times. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "extremely ill/horribly ill".  Additional information: Having covid three times was a better reaction than she had to having the covid vaccine times two and one booster. Made her extremely ill and she was having long-term covid effects. The covid vaccine times two and the booster times one made her horribly ill.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300340351 same patient, drug and event with different dose;US-PFIZER INC-202300340350 same patient, drug and event with different dose;
Full body aches, chills, headache, dizziness, nausea, loss of appetite, fatigue
ROTATEQ, PEDV AX HIB, RECOMBIV AX HB, GARDASIL 9 and VAQTA that went out of range were potentially administered; No additional adverse effect reported; Information has been received from a nurse istant and refers to a patient of unknown age and gender. There was no information about patient's concurrent conditions, medical history, concomitant medications or drug reactions/allergies.  On unknown dates, the patient was potentially vaccinated with doses of the following vaccines that were out of range: hepatitis b vaccine (recombinant)(RECOMBIVAX HB), lot # R028529 and expiration date of 09-JUN-2021, lot # T004378 and expiration date of 01-NOV-2022 and lot # R021372 and expiration date of 25-MAY-2021, hepatitis a vaccine, inactivated(VAQTA) lot # T020442 and expiration date of 26-JAN-2022 and lot # T014835 and expiration date of 17-JUL-2021, haemophilus b conjugate vaccine (meningococcal protein conjugate)(LIQUID PEDVAXHIB) lot # T001208 and expiration date of 09-JUN-2022 and lot # T020615 and expiration date of 13-MAR-2023, hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number 1621926 and expiration date of 28-NOV-2021 and lot # 1602284 and expiration date of 26-SEP-2021 (route of administration and anatomical location were not reported) and with rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # 1676322 and expiration date of 21-APR-2021, lot # 1688822 and expiration date of 20-NOV-2021 and lot # 1691301 and expiration date of 12-DEC-2021 per oral route, all for prophylaxis, which were stored in the following ranges: 9 Celsius degrees to 25 Celsius degrees (8.53 Celsius degrees) for 15 minutes and 9 Celsius degrees to 25 Celsius degrees (11.6 Celsius degrees) for 45 minutes.  No previous temperature excursion was reported. No additional adverse effects were reported.  Digital data logger was involved.  This is one of several reports from the same reporter. ; Sender's Comments:  US-009507513-2103USA003717: US-009507513-2103USA005236: US-009507513-2103USA005237: US-009507513-2103USA005239: US-009507513-2103USA005240: US-009507513-2103USA005241: US-009507513-2103USA005234: US-009507513-2103USA005233: US-009507513-2103USA005235:
Rash at injection sight appeared two days after administration, itching, discolored bump, approximately 3 x 3 inches. Rash moved to legs in itchy, hive-like patches and bumps.
SADDLE PULMONARY EMBOLISM 3/10/2022 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, W OTHER BEHAVIORAL DISTURBANCE  PULMONARY EMBOLISM, UNSPECIFIED. 1/25/2022 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, W OTHER BEHAVIORAL DISTURBANCE  ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 3/10/2022 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, W OTHER BEHAVIORAL DISTURBANCE  ACUTE DVT OF LEFT LEG, UNSPECIFIED VEIN 1/25/2022 UNSPECIFIED DEMENTIA, UNSPECIFIED SEVERITY, W OTHER BEHAVIORAL DISTURBANCE
My monthly periods have always been 28 days apart, lasting for 4 days. Consistent like this for years, except when pregnant. After my second covid vaccine, my period lasting for twice as long, and with twice the blood loss. I had worse fatigue, mood swings, and ?brain fog? during this time as well. All very atypical for me.
The patient felt lightheaded while walking to the post-vaccination area and she voluntarily laid down on the floor. The patient reports a history of anxiety and fainting post vaccinations and said this occurred when she received the HPV vaccine. The patient's legs were elevated, cool compress to the forehead and vital signs assessed.
Patient said his pain level was 9 out of 10 that night. took Tylenol ES.  Next morning ( 10-24) he complained he could not raise his left arm at all
This spontaneous report as received from a pharmacist refers to an unknown number of patient of unknown age. The patient were vaccinated with doses of GARDASIL (lot# not reported) store at high as 9 C several times a day for an unknown period of time. No adverse effect was reported. It was unknown if the patient sought medical attention. Follow up information has been received from the pharmacist stating that all patient information was recorded in the Immunization Registry. At the time of reporting, the pharmacist did not have access to the information that was listed in the Immunization Registry. The pharmacist stated that she would speak to her supervisor to see if patient identifiers could be supplied. This is one of several reports received from the same source. Additional information has been requested.
The symptoms were relatively mild. They included a cough, congestion, and mild body aches. The body aches only lasted one day. On Friday, December 23, 2023, I tested positive for COVID-19. I contacted my doctor. He prescribed PAXLOVID the same day. I took PAXLOVID for five days. I tested negative for COVID-19 on December 29 and 30, 2022. I rebounded on December 31, 2022. The symptoms returned. I remained positive for COVID-19 until January 5, 2023. I have been symptom free and negative for COVID-19 since January 6, 2023. I don't recall being exposed before testing positive for COVID-19.