chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I felt ok right after the injection but about 2 hours later I started experiencing a pressure headache, gradually felt very poorly and took a nap for a few hours.  Upon waking I felt ok but after walk; weakness; felt very poorly; This is a spontaneous report from a contactable other health care professional. A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot number: EL1284), intramuscular on 04Jan2021 11:45 at single dose at left arm for COVID-19 immunization. Medical history included hypothyroidism, psoriasis. Concomitant medications included etanercept (ENBREL), and levothyroxine. The patient felt okay right after the injection but about 2 hours later, on 04Jan2021 14:30, she started experiencing a pressure headache, gradually felt very poorly and took a nap for a few hours. Upon waking the patient felt okay but after walking around the house for about 20 minutes, the headache started up again and the same awful feeling of weakness so she laid down and took another 2 hours nap. When the patient woke up the second time she felt as though nothing had happened, was feeling fine. So the patient would say the side effects lasted for about 5 hours. The outcome of the events was recovered on 04Jan2021 17:00.
Rash; This case was reported by a nurse via call center representative and described the occurrence of rash in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXB58AA, expiry date 30th September 2022) 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.   On 16th February 2022 15:30, the patient received the 1st dose of Bexsero (intramuscular) .5 ml. On 16th February 2022, the patient started Bexsero Pre-Filled Syringe Device. In February 2022, less than a day after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the rash to be related to Bexsero and Bexsero Pre-Filled Syringe Device. 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 patient received dose of Bexsero into the left deltoid. At 12:30 pm next day, the patient called the office to report she was experiencing a rash. The rash resolved the following day.  The reporter reported that the doctor had already made a report to VAERS of this adverse event to Bexsero. The Agency representative did not asked for their permission but reporter details were provided.
After 15 min of observation, no adverse reaction noted, but 25 minutes later when pt returned, pt c/o difficulty breathing, chest pain, and itching. EPI PEN Adult 0.3mg administered. Transferred to ER.
Patient stated she noticed redness, pain and warmth to the area 5 hours post injection. She presented for a nurse only visit 2 days later (4-11-18) and was asked to see a provider who marked the area and discussed comfort plan. Patient presented 2 days later again (4-13-18) for recheck as area worse, so seen by same provider as 4/11/18 and antibiotics were ordered for a diagnosis of Cellulitis. Patient to follow up with this provider on 4/18/18.
STARTED WITH BRUISING AND HUGE BASEBALL SIZED SWELLING OF HIS ARM.
This spontaneous report as received from a physician via a company representative refers to a female patient of unknown age. No concomitant medication, pertinent medical history or drug/allergies were reported. On an unknown date, the patient was vaccinated with a dose of GARDASIL injection (dose, route, lot number and expiration date were not reported). On an unknown date, the patient developed menstruation changes and disruption. The outcome of the event was unknown. The relatedness between the event and GARDASIL injection was not reported. Additional information has been requested.
Immediately after injection patient stated he did not feel well and passed out. He was extremely diaphoretic and once he woke up began dry heaving and vomiting. He stated he was too dizzy to stand and just wanted to lie down. We called an ambulance to come and treat him. He explained to the paramedics he had been out drinking and partying late the night before and did not eat or drink anything before he came to get his vaccine. We determined that he was more dehydrated and hungover than having an actual reaction to the vaccine itself.
Sore Arm; low grade fever of 100 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and PYREXIA (low grade fever of 100 degrees F) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014M20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore Arm) and PYREXIA (low grade fever of 100 degrees F). At the time of the report, PAIN IN EXTREMITY (Sore Arm) and PYREXIA (low grade fever of 100 degrees F) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 (High) low grade fever of 100 degrees F.     Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.  After first dose, the patient did not get sick.
Pain in his leg, the pain was in the middle part of the back of the lower part of his leg, the fibula; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in his leg, the pain was in the middle part of the back of the lower part of his leg, the fibula) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in his leg, the pain was in the middle part of the back of the lower part of his leg, the fibula). At the time of the report, PAIN IN EXTREMITY (Pain in his leg, the pain was in the middle part of the back of the lower part of his leg, the fibula) outcome was unknown.      No relevant concomitant medications was reported. Treatment information was not provided.  This case was linked to MOD-2021-399919 (Patient Link).
31OCT95 PC from mom stating pt had a sz noc recvd vax 29SEP95; requesting no more pertussis;pt had a fever when went to bed described as not particularly high & given APAP;feeling funny;shaking all over whole body;chill, feverish;jerking,
Anxiety  Felt like fainting Dizziness Tingling and cramping in hands Weakness EMT came to Observation area Vitals  BP #1) 173/133  Pulse 86 O2 Sat 100% #2) 95/72 Patent refused transport to hospital
The day after my second vaccine I woke up with a headache from the neck up to the right side of my head.  I saw a doctor for this and he explained that it is occipital neuralgia.  I am having some type of nerve block done in a few weeks and then possibly radio frequency ablation to stop the pain.  I am currently taking Gabapentin to take the edge off the pain.
24 hr after vaccine noticed peeling near injection site later in am, noticed warm & red. Came to pharmacy at 4:45 pm. Injection site was red, warm. Approx 1 1/2 in area of redness. Advised to take BENADRYL, TYLENOL & ice to area. Some infreq shooting pain in area. 11/9/12 pt much better.
RHEUMATOID ARTHRITIS FLARE UP; This spontaneous report received from a patient concerned an adult female. The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis. The patient received covid-19 vaccine ad26.cov2.s (dose series 1, suspension for injection, intramuscular, batch number was not reported) dose, 1 total, start therapy date were not reported for covid-19 vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis. No concomitant medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.  On an unspecified date, the patient experienced Rheumatoid arthritis symptoms returned (Rheumatoid arthritis flare up) and received treatment medications included methotrexate. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The outcome of rheumatoid arthritis flare up was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0.20220100123-covid-19 vaccine ad26.cov2.s -Rheumatoid arthritis flare up . This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY.
Dizziness 15 minutes after vaccination. Fell and hit head on way back to class. No loss of consciousness. Was able to return to class after 30 minute rest in principal office.
Mom reports red and raised around injection site. Lasted for 2 days post injection. Went away day 3, Patient went to pediatrician who deemed it an allergic reaction to a component of the FLUZONE vaccine.
The next day, I found a swollen lymph node above the left supraclavicular bone. (Testing showed I have two the larger is 1.5 x 1.0 x 1.7 cm and it has a thickened cortex.) It's still present. Not painful. It's quite prominent right now and yesterday I thought it was gone. So maybe that is because of the site of where it's at. It got measured by my regular doctor. I've had multiple doctor visits. I went to a specialist who did an ultrasound on June 11th. I have not had bowel symptoms. Have an appt with a general surgeon to have it checked on July 7th.
Patient received vaccination and walked without issue to observation area. Shortly after patient sat for observation patient stated they began to "feel funny" and stood to talk to technician. He took a few steps and then lost consciousness. Patient fell and landed on his side. Patient does not remember falling or hitting the floor. BP take and was 160/110 and then was 150/105. ED was called and paramedics arrived on scene for assessment within 10 minutes of call. EMS stated patient did not need to be taken by ambulance to ED as he was alert and oriented but advised that he have someone take him and get checked out. Patient states that he will follow up at ED or Urgent Care
Patient received her second dose of Covid vaccine on 04/08/2021 around 2 PM. She reported around 2 AM Friday 04/09/2021 she woke up feeling lightheaded as if she was going to pass out. She is an RN and felt that her pulse was irregular. She proceeded to the emergency department where she was treated. She reports her EKG showed a-fib with RVR and an xray showed new onset mild "CHF" or fluid around her heart. They did not cardio-vert her as she reports she was "stable". She was sent home on eliquis and metoprolol. Over the weekend 04/09-04/11/2021 she reported irregular pulse anywhere from 45-135 BPM. She did report a 5 pound weight gain during that time. On Monday 04/12/2021 she followed up with her primary care physician, Dr. of Health. She reports on her way to the doctor she felt as if "something changed" and her heart rate was no longer irregular. She did have another EKG done in office and she reports that EKG showed normal sinus rhythm. She is seeing a cardiologist on Wednesday 04/14/2021. She reports after her first vaccine on 03/11/2021 she had mild side effects of fatigue, fever, and chills. She states she does not have any cardiac issues but does report "a few years ago" she had drank a energy drink and had a-fib from that.
aching; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 24Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On 25Feb2021, the patient was aching. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient experiencing itching around injection site, started 10 mins after injection. Pt was given 25mg of benadryl.
Myalgia cervical/axillary lymphadenopathy, injection site tenderness Narrative:
Hospitalized on 2/22/22 for scheduled repeat cesarean section G2, P1-0-0-1 at 39 weeks gestation
Since the vaccination, has the patient been tested for COVID-19; Covid 19 positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 07Feb2021 as dose 1, single (Lot number: EM9809), on 22Feb2021 as dose 2, single (Lot number: ENG205) and on 14Nov2021 as dose 3 (booster), single (Lot number: FF2589) at the age of 45 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: NORVASC. Past drug history included: Amoxicillin, reaction(s): "known allergies: amoxicillin", notes: known allergies: amoxicillin; Doxycycline for known allergies: doxycycline, notes: known allergies: doxycycline. The following information was reported: COVID-19 (medically significant) with onset 15Jul2022, outcome "not recovered", described as "Covid 19 positive"; DRUG INEFFECTIVE (medically significant) with onset 15Jul2022, outcome "not recovered", described as "Since the vaccination, has the patient been tested for COVID-19". The events "since the vaccination, has the patient been tested for covid-19" and "covid 19 positive" required physician office visit. The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (13Jul2022) Positive, notes: covid test type post vaccination=Nasal Swab covid test date=13Jul2022, covid test result=Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Pt recv vax & devel rash w/20 lesions "all over" on trunk,arms & groin. Rash reportedly looked like varicella.
second dose in series was given 21 days after the first dose instead of 28 days. did not result in any adverse reactions
itchy rash for second dose; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (itchy rash for second dose) 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.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (itchy rash for second dose). At the time of the report, RASH PRURITIC (itchy rash for second dose) outcome was unknown. Not Provided          No Treatment was reported. No concomitant medication was reported.   This case was linked to MOD-2021-024676 (Patient Link).
fever 102-104 devel evening of 30AUG94 extending into 31AUG94; shaking @ times advised MD follow MD contacted-advised ER; family did not go AM of 1SEP94 temp nl; pt back to nl; MD gave order for ped DT for following immun
Pt. was given an unneeded dose of varicella vaccine. Age of patient at time of event: 9 years 6 months 24 days.
Initial information received on 23-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves Adult patient (age and gender not reported) who experienced an egg allergy, while he/she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date, the patient received a dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine lot number not reported. It was a case of contraindication to vaccination. It was also reported that the reporter not know if the patient could eat eggs and tolerate to some extent or if she had an anaphylactic reaction. No Lab data was reported. Final diagnosis was egg allergy (Contraindication to vaccination). It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not Applicable for gave a patient FLUZONE HIGH DOSE who has an egg allergy. Documents held by the sender: none.
spot where I had the shot, is red; spot where I had the shot, is hard; spot where I had the shot, is itchy; spot where I had the shot, is swollen; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE ERYTHEMA (spot where I had the shot, is red), VACCINATION SITE INDURATION (spot where I had the shot, is hard), VACCINATION SITE PRURITUS (spot where I had the shot, is itchy) and VACCINATION SITE SWELLING (spot where I had the shot, is swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (spot where I had the shot, is red), VACCINATION SITE INDURATION (spot where I had the shot, is hard), VACCINATION SITE PRURITUS (spot where I had the shot, is itchy) and VACCINATION SITE SWELLING (spot where I had the shot, is swollen). At the time of the report, VACCINATION SITE ERYTHEMA (spot where I had the shot, is red), VACCINATION SITE INDURATION (spot where I had the shot, is hard), VACCINATION SITE PRURITUS (spot where I had the shot, is itchy) and VACCINATION SITE SWELLING (spot where I had the shot, is swollen) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medication was received by the patient No Treatment was received by the patient.
She presented to the ED complaining of weakness that has worsened over the past 2 days. The patient normally ambulated with a walker at home but has not been able to walk for the past 2 days at all. She states her son called EMS, as she has called the fire department to come to her home and help her walk 3 times over the last few days. She states she has body aches and cough but denies shortness of air and chest pain. The patient is vaccinated for COVID-19. She was found to be positive for covid-19 in the ED
Arm is swollen, sore, warm to touch. Patient has tried applying an ice pack and rubbing the area. She has also tried Aspercreme. The swelling went down slightly after applying the ice pack.
Patient was mistakenly given 1mL for their primary dose. The provider themselves prepared the vaccine and thought that 1ml was the dosage for the primary vaccine
Injection site red with heat radiating  from site. Itching all over body. This is one week and one day after the first shot.
pt recvd vax; rash over groin,under arms,back;on 14dec94 t of 102.6; apap given & MD notified; rash & t gone by 17dec94;
Headache, Sedation, Myalgia, Arthralgia, Fever, Diarrhea, Chills, Swollen lymph nodes 3 days post vaccine,  Pain @ injection site Narrative:
12 hours post-injection, strong aches in legs, arms, fingers, ears. Tylenol eased symptoms for two hours, but then they returned. All in all, had aches for 12 full hours starting 12 hours post-injection. 101 fever started 15 hours post-injection, lasting 8 hours. No appetite for full 24 hours post-injection. Resting heart rate 90-107 BPM 12-24 hours post-injection. 28 hours post-injection, pressure in chest. Worse when laying down or when swallowing. Pain came in waves. On for 3 minutes, off for ~40 seconds. Laying down made pressure increase more quickly. Dull, deep pressure, squeezing sensation. HR 90-98.
TRANSVERSE MYELITIS; This spontaneous report received from a patient via another manufacturer concerned multiple patients. The patient's weight, height, age and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: unknown) dose, start therapy date were not reported for an unspecified indication. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced transverse myelitis (spinal inflammation).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of transverse myelitis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received from a patient via another manufacturer concerned a patient who experienced transverse myelitis on an unspecified date after receiving the vaccine. Medical history, concomitant medications, laboratory results, diagnostics, treatment, and outcome were not reported. Information is limited in this case, and the occurrence of transverse myelitis could represent background incidence of such events in the general population. Therefore, the relationship of transverse myelitis to vaccination is considered unclassifiable due to insufficient information.
This is a spontaneous report from a contactable consumer (the patient). A female patient of an unspecified age and race/ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date three years ago, at single dose for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced pain at the injection site that within 2 or 3 days it was getting more and more painful. Three years later she was still in pain every day. The patient underwent lab tests and procedures which included nuclear magnetic resonance imaging and x-ray on unspecified date: there was nothing to see. The events were non serious with outcome of unknown.
Coughing; Fever; Achy; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Coughing), PYREXIA (Fever) and PAIN (Achy) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 016B21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history ).   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced COUGH (Coughing), PYREXIA (Fever) and PAIN (Achy). At the time of the report, COUGH (Coughing), PYREXIA (Fever) and PAIN (Achy) outcome was unknown.
Information has been received from a physician assistant concerning a 40 year old female with sickle cell disease who on 13 Sep 2006 was vaccinated with a dose of Varivax. Subsequently the patient experienced chills, headache, fever 102F and papular rash. Subsuently, the patient was recovering from chills, headache and fever. The patient's papular rash persisited. Additional information has been requested.