chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Diagnosed with COVID about two weeks later after shot; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with COVID about two weeks later after shot) in a 62-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced COVID-19 (Diagnosed with COVID about two weeks later after shot). The patient was treated with Immunotherapy (monoclonal infusion on 23-Mar-2021) for COVID-19. At the time of the report, COVID-19 (Diagnosed with COVID about two weeks later after shot) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 test: positive (Positive) Diagnosed with COVID about two weeks later after shot..         No concomitant medications were reported  Treatment included Monoclonal infusion on 23-March-2021.
At 2mths routine vax.. approx 1 hr after started having unconsolible screaming.. Was fussy/crabby for approx 2wks after. At 3mth routine vax. Pertussis vax was eliminated. Approx 1 hr after started having inconsolable crying.. Tylenol was administered after each vax approx every 4 hours.
Information has been received through the Merck Pregnancy Registry from a physician concerning a 24 year old female, with no pertinent medical history, who on 21-JUN-2007 was vaccinated with a first dose of GARDASIL. Subsequently, the patient became pregnant. On an unspecified date the patient was seen in the doctor's office for an obstetrics visit. "The routine obstetrics lab work was taken" (results not reported). Her last menstrual period was 27-MAY-2007 and the estimated date of delivery was 02-MAR-2008. Follow-up information was received via phone call on 22-SEP-2008 from two other health professionals indicating that the baby was born on 28-FEB-2008 by C-section. The baby was born normal and healthy. There were no problems with the mother or the baby. The mother was seen for post partum visit and "everything is just fine". Upon internal review, birth by C-section was determined to be an other important medical event. Additional information is not expected.
The day after, I woke up with a bad headache and I had the headache for a good 19 days. The doctors thought I was over-reacting. It was a bad headache on left side of head. I was just not feeling well. On the 19th day, it went away. I still from time to time I do still feel pain in the head on the left side. I had a lot of tightness in my left leg. In  previous years, I have had blood clot in my leg and after birth in my stomachs - so with the pain in calf I called a doctor and went. They did a visual. After a lump appearing in my leg, an ultrasound was scheduled. I went  Urgent care on May 10 - she ordered an ultrasound but her office didn't ever follow up with me. On 17th, I saw my Primary care and she sent me straight to get an Ultrasound - on the 18th, it revealed I had a blood clot.
The joints of her fingers, wrists and toes swelled and were painful.  This increased over the next couple of days then stared to resolve.
I immediately began to feel my arm asleep, it wastes the ring finger and the little fimger. then i was taking iboprofen ) sr, order to me, the was eors and he gave me diclofenacoy take it 5 day but i star havin ptoblems with my eyes and legs.  my my sensory nervous systerm is very devilite. I ca"t smell and I have no Taste  this week i did an MRI and x ray
18JUL95 11x10 erythematous-warm hot area, tender; 2x2 satellite redness area red line towards axilla; t101.2; f/u 21JUL95 to urgent care
REACTIONS FOR 3 MONTHS AFTER THE VACCINE; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced reactions for 3 months after the vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from reactions for 3 months after the vaccine. This report was non-serious. This case, from the same reporter is linked to 20230116143.
Patient received a dose of Pfizer COVID-19 vaccine pediatric formulation (5-11 years) that may have been reconstituted with a single-use vial of 0.9% NS entered into multiple times to reconstitute other vials of Pfizer vaccine. Staff did not realize the 10mL vial was for single-use only (to take out 1.3mL then discard). Each time the vial was used, it was swabbed with alcohol and a new syringe was used to enter the vial to add the diluent to the Pfizer vaccine for reconstitution. The 10mL, 0.9% NS vial disposed of at the end of each day. The patient did not experience any adverse reaction. At recommendation and due to lack of stability data, it was advised to revaccinate the patient.
New Onset Atrial Fibrillation (A-fib); no prior history of A-Fib; started two weeks after my second booster/4th shot -- all four shots/doses we Pfizer Covid-19 vaccine,  I went to doctor due to shortness of breath that lingered for several.  I am very athletic and have strong cardiovascular fitness, so this was unusual.  I was diagnosed on July 8, 2022 with A-fib (by EKG), and then echocardiogram the same day (July 8, 2022)  After receiving mechanical cardioversion, the A-fib has resolved.
patient received vaccine on Jan 23, 2021 passed away on Jan 24, she was already on hospice, so unclear if due to vaccine or other issues. Was at her baseline before and after vaccine per facility, had b'fast and passed away at noon on Jan 24
fatigue; headache; nausea; lightheadedness upon standing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 10Mar2022 16:00 (Lot number: Fm0698) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies: Sulfa drugs" (unspecified if ongoing). Concomitant medication(s) included: FERROUS SULFATE; ATORVASTATIN [ATORVASTATIN CALCIUM]; LORATADINE; AIRBORNE. The following information was reported: FATIGUE (non-serious) with onset 13Mar2022 12:00, outcome "recovering", described as "fatigue"; HEADACHE (non-serious) with onset 13Mar2022 12:00, outcome "recovering", described as "headache"; NAUSEA (non-serious) with onset 13Mar2022 12:00, outcome "recovering", described as "nausea"; DIZZINESS (non-serious) with onset 13Mar2022 12:00, outcome "recovering", described as "lightheadedness upon standing". Therapeutic measures were not taken as a result of fatigue, headache, nausea, dizziness.  Additional information: No other vaccine in four weeks. Other medications in two weeks: ferrous sulfate, atorvastatin,loratadine, airborn.  No follow-up attempts are possible. No further information is expected.
Patient describes swelling and erythema upper arm and extending to triceps area with temp 101 for 2-3 days.
Information has been received from a registered nurse, concerning a 64 year old male patient with hypertension, coronary artery disease, gout, obesity, hypercholesterolaemia, hyperthyroidism and haemorrhoids, who on 02-APR-2008 was vaccinated IM in the left arm, with a dose, 0.5 ml, of pneumococcal 23v polysaccharide vaccine (lot # 659487/1960U). Concomitant therapy included levothyroxine Na (SYNTHROID), aspirin, indomethacin (INDOCIN (indomethacin)), atorvastatin calcium (LIPITOR), metoprolol succinate (TOPROL XL TABLETS), testosterone, nitroglycerin and HCTZ/triamterene (MAXZIDE). On 03-APR-2008, about 24 hours after the vaccination, the patient developed fever (value not specified), and his left arm was hot and red. On 04-APR-2008, he presented to the office, and his arm was also swollen. At the time of this report, the patient had not recovered from the events. This is one of 2 reports from the same source. Additional information has been requested. 07/30/09 This is in follow-upto report(s) previously submitted on 7/30/2008. Initial and follow up information has been received from a registered nurse, concerning a 64 year old male patient with hypertension, coronary artery disease, gout, obesity, hypercholesterolaemia, hyperthyroidism and haemorrhoids, who on 02-APR-2008 at 10:00 AM was vaccinated IM into the left deltoid, with a dose, 0.5 ml, of PNEUMOVAX (lot # 659487/1960U). Concomitant therapy included SYNTHROID, aspirin, INDOCIN, LIPITOR, TOPROL XL tablets, testosterone, nitroglycerin and MAXIDE. On 03-APR-2008, about 24 hours after the vaccination, the patient developed fever (value not specified), and his left arm was hot and red. On 04-APR-2008, he presented to the office, and his arm was also swollen. At the time of this report the patient had not recovered from the events. In follow up information from the doctor's office it was reported that patient had heat, redness, swelling and fever and he recovered on an unknown day. This is one of 2 reports from the same source. Additional information has been requested.
Lower left side abdominal pain; Acute abdominal pain; stiff arm; Muscle pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Acute abdominal pain), ABDOMINAL PAIN (Lower left side abdominal pain), MUSCULOSKELETAL STIFFNESS (stiff arm), MYALGIA (Muscle pain) and FATIGUE (fatigue) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff arm), MYALGIA (Muscle pain) and FATIGUE (fatigue). On 27-Feb-2021, the patient experienced ABDOMINAL PAIN (Acute abdominal pain). On 02-Mar-2021, the patient experienced ABDOMINAL PAIN (Lower left side abdominal pain). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (Acute abdominal pain) and ABDOMINAL PAIN (Lower left side abdominal pain) outcome was unknown and MUSCULOSKELETAL STIFFNESS (stiff arm), MYALGIA (Muscle pain) and FATIGUE (fatigue) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications reported were none.
received / 2nd dose / October 2014 / receiving "catch up doses" (16-JUN-2021); administration / to 7/o old; 1st dose / in August 2014, 2nd dose / October 2014 / receiving "catch up doses" (16-JUN-2021); This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 7-year-old male patient who received DTPa (Infanrix) (batch number 49TM3, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included DTPa (Infanrix).   On 16th June 2021, the patient received the 3rd dose of Infanrix and Infanrix Pre-Filled Syringe Device. In October 2014, the patient received the 2nd dose of Infanrix and Infanrix Pre-Filled Syringe Device. In October 2014, not applicable after receiving Infanrix and Infanrix Pre-Filled Syringe Device, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device and an unknown time after receiving Infanrix, the patient experienced drug dose administration interval too long. On 16th June 2021, the patient experienced drug dose administration interval too long and inappropriate age at vaccine administration. The action taken with Infanrix Pre-Filled Syringe Device was unknown. On an unknown date, the outcome of the drug dose administration interval too long, inappropriate age at vaccine administration and drug dose administration interval too long were 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 provided as follows: The reporter stated that, the patient received catch up doses. The patient received 1st dose of Infanrix in August 2014 and 2nd dose of Infanrix October 2014, which led to lengthening of vaccination schedule. The patient received 3rd dose late than the recommended time interval at the age of 7 years old, which led to drug dose administration interval too long, inappropriate age at vaccine administration. The reporter consented to follow up.
fever & sz 1130PM 25SEP96 activity lasted 10seconds next sz 11:30 26SEP96 10seconds;seen in office IV started, phenobarbital given to control cont sz transported by medic unit to hosp ER then adm for 4 days;
Pt had fever on 22JUN & 23 then had over again 27-29JUN; had chills & dizziness; 10JUL broke out in a rash; dx measles;
pt recv vax; blood test showed that pt failed to seroconvert;titers were based on a qualitative test;
This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age/gender. The patients' concurrent or historical conditions were not provided. Concomitant therapies were not reported. On an unknown date the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, frequency, route, lot number and expiration date were not reported). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
After having shot started having shortness of breath for 3 days,  Hives began by 4pm of the day I got the shot, one week later went back to my doctor.  He told me that I am the second person this week and that its the H1N1 additive.  He prescribed me meds to help with the itch of the hives but the hives are twice as bad, they were just under my breast and now are on my entire torso in large rings. I am also having heart palpitations daily.
Tuesday at 3 am she noticed redness, and swelling. Then at 7pm she noticed the redness spread to under her arm and it was sensitive to touch.
Arm hurts; Tired; A spontaneous report was received from a healthcare professional concerning a 79-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm hurts, tired.  The patient's medical history was not provided. Concomitant medications reported were eloquist 2.5 mg twice a day, gleecax for stomach cancer for drug use for unknown indication.  On 22 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 023M20A) via unknown route for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced the event(s) arm hurts, tired.  Treatment details included not provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), arm hurts, tired was unknown.
This spontaneous report as received from a pharmacist refers to unspecified number of patients without demographics information. It was reported that the patient might have received expired ZOSTAVAX (Lot # 665528/0710Z, expiration date 28-APR-2011), but was unsure if there were additional patients or when they would have received the expired vaccine. No other co-suspects were reported. No concomitant medications were reported. Follow up information via telephone call also stated that the pharmacist did not have any information regarding the unspecified number of patients. She was attempting to identify the patients if there were any, because they would need to be re-vaccinated. The outcome of received expired ZOSTAVAX was unknown. This is one of two reports from the same source (the other report MARRS # 1207USA006024). All telephone attempts to obtain follow-up information have been unsuccessful. Additional information has been requested.
This spontaneous case was initially received on 16-Sep-2015. The case report was received from a Health Professional and concerns a 59 years old female patient who was not taking any medications that would increase her likelihood of bleeding, nor did she have any medical conditions that would increase her risk of bleeding. The patient stated that she "bruises easily" after being administered the vaccine. Weight: not provided, Height: not provided. For concomitant medication and therapy dates refer to the appropriate report sections. The patient received AFLURIA for indication protection against seasonal influenza on 13-Sep-2015 - 13-Sep-2015, Batch no: U54506, Route of administration: Intramuscular, Dose: 0.5 ml once. AFLURIA was stored correctly and the indication for use was approved as per the Product Information leaflet. Additional suspect drug (s): No additional drug suspected. Reaction (s)/event (s) and outcome: On 13-Sep-2015, immediately after AFLURIA administration the patient began bleeding profusely from the site (injection site) and completely soaked a bandage applied to the site within three seconds (non serious, outcome: Recovered/ Resolved). The bleeding resolved spontaneously on the same day. Action taken: AFLURIA was discontinued.
BREAKTHROUGH COVID INFECTION. TESTED POSITIVE ON 09/28/2021. PATIENT FULLY VACCINATED ON 03/09/2021.
very sore arm very pain full lump   burning in my left arm pain in my back i upper chestthis is stillgoing on my arm burns and hurts still plus lose bowel movements  for 3 weeks
Moderna COVID-19 Vaccine EUA, one week after receiving vaccination, a lump the size of a quarter, very red and hot to the touch and rash that expanded two days after noticing of rash. Rash/lump lasted almost 5 days.
patient received expired pfizer exp in fridge was 3/26/22 pt had no adverse effects
12 y/o patient was in another country for 3 months and reported receiving his second dose of the Pfizer vaccine on 8/31/2021.  Patient returned home on 9/2/21, and awoke on 9/3/21 with complaints of acute midsternal chest pain - woke him from sleep, 10/10 and constant, not burning but was pleuritic.  Did not improve with positioning or drinking water.  Associated with nausea and palpitations and globus sensation.  Denies associated dizziness, HA, syncope, cough or SOB/DOE.  Unknown exactly where in the country patient received vaccine and what the lot numbers were.  Dx with suspected Acute myopericarditis.
Patient presented on 11/13/17 to pharmacist with signs of allergic reaction: rash, itching, pain, swelling, redness, fever. Patient was taking 2 BENADRYL every 6 hrs as needed and patient stated he is getting better. Follow up call on 11/15/17 also suggested patient take ZYRTEC in place of BENADRYL and to apply cool compresses.
DIZZINESS,BRAIN FOG,FATIGUE,PALMS AND FEET SWEATING,FLUCTUATING BODY TEMPERATURE,SLEEPINESS - ALL SYMPTOMS ARE PRESENT 24/7
Sudden onset shakiness and became light headed with tunnel vision. Almost passed out. Episode lasted about 5 minutes but generalized weakness lasted for about an hour.
Drug ineffective; COVID 19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulpha allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown", described as "COVID 19". Therapeutic measures were taken as a result of drug ineffective, covid-19 as Paxlovid from 28Feb2023 to 06Mar2023.  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-202300108669 same patient, different drug and event.;
NO ACTUAL EVENT !!!! JUST THE PATIENT HAD RECEIVED THE FLU SHOT THE DAY BEFORE AND THEN ON 10/27/22 THE PHARMACIST (MYSELF) GAVE A FLU SHOT INSTEAD OF THE COVID 19 BOOSTER. SUBSEQUENTLY COVID SHOT GIVEN BUT THE PT DID RECEIVE 2 FLU SHOTS WITHIN 24 HRS
Patient developed redness & warmness on her arm about 1 inch below the injection site. It's about 3 inches wide and very painful. She's been used ice at night but still hurting.
patient c/o lightheadness at 11:55am.  Blood pressure was 142/90.  Consulted with Doctor.  observed for 10 more minutes. Patient started c/o numbness in face, shortness of breath and chest pain around 12:05pm.  02 was 99%. Consulted with Doctor and paramedics called. Patient was confused and had difficulty with balance while being transferred to ambulance.  Transported to  medical Center at 12:18pm