chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Headache Vomiting & Nausea Dizziness Muscle Pain Difficulty Breathing no wheeze. Given EPI PEN x1, IV ATIVE & MORPHINE for symptomatic treatment
Site: Pain at Injection Site-Mild, Site: Redness at Injection Site-Medium, Additional Details: Redness around injection site from shoulder to elbow joint
SWELLING CHEEKS; SWELLING LIPS; This case was reported by a physician via call center representative and described the occurrence of cheek swelling in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th October 2019, the patient received Shingrix. On 14th October 2019, 6 days after receiving Shingrix, the patient experienced cheek swelling and lip swelling. On an unknown date, the outcome of the cheek swelling and lip swelling were unknown.   It was unknown if the reporter considered the cheek swelling and lip swelling to be related to Shingrix.  Additional details were provided as follows: The reporter stated that the patient experienced cheek swelling and lip swelling after vaccination. The reporter did not consent to follow up.
developed a lump in my throat within a half hour after receiving vaccine. I took Benadryl at 7pm without any improvement. Feeling of lump improved by Monday and today feels irritated in that affected area. No other treatment.
Narrative: Patient received J&J Covid vaccination in April 2021, Patient called in on June 21 reporting symptoms of intermittent chest pain and increased shortness of breath that started in April. Of note patient reports 1 ppd smoker for 40 years, and following report of symptoms patient completed further work up with cardiology, pulmonology, and oncology and in July 2021 was diagnosed with non-small cell lung cancer for which he is currently being treated
Two days after receiving the vaccine, I developed a large rash on my left arm just below the injection site. The rash caused no discomfort and was left untreated to heal on its own.
Arm soreness , low back and hips aching chills and 101.1 temp mild headache . Tx with Tylenol / motrin temp gone down just feeling tried aching
PATIENT'S SISTER (AGE 20) CAME DOWN WITH A CASE OF CHICKEN POX (SHE HAD ITCHING BUMPS ALL OVER HER THAT BECAME SCABS) AND THEN HER BOYFRIEND GOT IT FROM HER BY REPORT OF THE MOTHER.
The day after vaccine administration, I had flu-like symptoms of muscle pain, headache, minor nausea. A couple weeks after my second dose of the vaccine, I found out I was pregnant - 2/24/2021. Based on ovulation tests, I likely conceived on 2/9/2021, which was prior to my second dose, but after my first dose. This may be unrelated, but I had a miscarriage at 6 weeks pregnancy this Sunday, 3/7/2021.
68YF Small bowel obstruction within 1 week of vaccine Patient had incarcerated incisional hernia with SBO, preserved bowel on  March 19 2021. Patient with alcoholic cirrhosis who presented with abdominal pain, nausea, and vomiting.  She was found to have a small bowel obstruction and an umbilical hernia.  She had electrolyte derangements including hypokalemia and AKI and was admitted to hospitalist service with surgery consulting.  She improved with NG tube decompression, IV fluid resuscitation, and electrolyte repletion.  On 3/19 she underwent umbilical hernia repair and was found to have an incarcerated umbilical hernia. On day of discharge she tolerated advancement to regular diet.  Her AKI and hypokalemia resolved.  She does have chronic thrombocytopenia due to her cirrhosis, with last available baseline platelet count in the 50s.  She did not have any significant bleeding postoperatively.  She did not have any signs of decompensation of her cirrhosis.  MELD Na is 13, with less than 2% 90-day mortality. Patient drinks 1-2 times a month now and did not have any signs of alcohol withdrawal.  CT abdomen and pelvis showed a right lower lung nodule at the base.  This should be monitored as an outpatient.  She was discharged to home in stable condition. Upon 4/13/21 Ambulatory Clinic visit:  Patient is recovering well from surgery.
ADMINISTRATION OF VACCINE 1 HOUR PAST RECOMMENDED STORAGE TIME; This spontaneous report received from a health care professional concerned a 34 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, expiry: 29-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced administration of vaccine 1 hour past recommended storage time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine 1 hour past recommended storage time was not reported. This report was non-serious. This case, from the same reporter is linked to 20210905756 and 20210905816.
24 hours of flu like symptoms and headache  Then fainted and suffered a skull fracture and subdues hematoma and frontal lobe edema
Fever, body ache, dizzy, headache for 2 days.  Ongoing headache, neck stiffness and dizziness.  Car sickness type feeling. Stiff neck and migraine.
Pt developed fever (101), fussiness and generalized hypotonia within 12 hrs after receiving Pediarix, ActHib, and Prevnar. Over the next few days an extensive work up was done (see below) and consultation was obtained with a pediatric hospitalist and a pediatric neurologist. No other cause for the symptoms was found and he gradually returned to baseline over the next 3 wks and has been normal since without any recurrence of symptoms and other etiologies for his symptoms emerging.
hot; a red spot one inch below the injection; painful; swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (a red spot one inch below the injection), VACCINATION SITE PAIN (painful), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE WARMTH (hot) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 13-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (a red spot one inch below the injection), VACCINATION SITE PAIN (painful), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE WARMTH (hot). At the time of the report, VACCINATION SITE ERYTHEMA (a red spot one inch below the injection), VACCINATION SITE PAIN (painful), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE WARMTH (hot) outcome was unknown.            Concomitant medications reported were blood pressure pills, cholesterol pills. Treatment details was not included.
Received the vaccination on 9/2/21 in the afternoon. When I woke up on 9/3/21, I felt very weak and was walking to the kitchen to make some tea. I had a hard time walking (Never happened to me before and I have no underlying health conditions). I then woke up on the kitchen floor with severe pain on the back of my head and my neck and shoulders. I then needed to go to the bathroom and I think i crawled there, but passed out once again on the way and once after using the bathroom. I passed out a forth time on my way to sit in a chair. I then was able to locate my phone and call for help. My doctors office sent an ambulance and I was admitted to the  Hospital. There I was given tests and procedures listed in "Item 19". I was kept overnight in the hospital for observation. I was very tired for the next few days and made an appointment to see the doctor on 9/9/21 because of it. After reviewing all the test and lab results, it was determined by Dr. that the fainting must have been a result of a reaction to the Shingrix vaccine.
11/3/2021 had wcc and 4 mo vaccines, pentacel, prevnar and rotavirus vaccines temperature to 100.4 after vaccines.  11/4/2021 at 1230 am seemed fussy. temperature to 102 (temporal and tympanic), gave  Tylenol.  Then in AM temp noted to be 100.2. Tylenol  given at 10am. Seemed fine at this time but a little fussy.  11/4/2021 3 pm: Temperature was normal. Started to fuss. Crying and then eyes rolled back and choking on saliva, threw head back. arched back, stiff. episode lasted 5 seconds.  stopped and then was fine.  smiled.  After episode seemed fine but more quiet.
Information has been received from a physician assistant concerning a 74 year old male patient with diabetes and aspirin allergy who on 30-APR-2009 was vaccinated IM in his left deltoid with a 0.5 mL dose of PNEUMOVAX (662599/1076X). Concomitant therapy included lisinopril, metformin, LIPITOR, glucosamine and ZYRTEC. On 30-APR-2009 the patient developed a swollen left shoulder. He was unable to move his shoulder and it was red. There was also a peeling blister on his shoulder but it might have been caused from a heating pad that the patient was using. The patient returned to the office on 01-MAY-2009 because of his symptoms and he was given prednisone taper. The patient went again to the office on 4-MAY-2009 and he was 90 % better. Additional information has been requested.
got the flu shot, still got flu; Initial information received on 15-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/non-healthcare professional (hcp).  This case involves an unknown age and unknown gender patient who got the flu shot, still got flu after receiving vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received suspect INFLUENZA VACCINE produced by unknown manufacturer (strength, formulation, route, dose: unknown) (lot number and expiry date: not reported) in unknown administration site for Prophylactic Vaccination (Immunisation).  On an unknown date, the patient developed a non-serious event of got the flu shot, still got flu (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported, but could've been much worse.   It is unknown if the patient had any medical history, concomitant disease or risk factor. It is unknown if there were lab data/results available.   Action taken with INFLUENZA VACCINE (INFLUENZA VACCINE) was not applicable.  It was not reported if the patient received a corrective treatment for the event (got the flu shot, still got flu).  At time of reporting, the outcome was Unknown for the event got the flu shot, still got flu.
positive for covid-19/ Had covid like symptoms; sore throat for 3 days; Was extremely tired/  Still feeling tired; severe headache; Arm hurt 2 days; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (positive for covid-19/ Had covid like symptoms), OROPHARYNGEAL PAIN (sore throat for 3 days), FATIGUE (Was extremely tired/  Still feeling tired), HEADACHE (severe headache) and MYALGIA (Arm hurt 2 days) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced MYALGIA (Arm hurt 2 days). On 20-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat for 3 days), FATIGUE (Was extremely tired/  Still feeling tired) and HEADACHE (severe headache). On 24-Apr-2021, the patient experienced COVID-19 (positive for covid-19/ Had covid like symptoms). On 19-Apr-2021, MYALGIA (Arm hurt 2 days) had resolved. On 24-Apr-2021, OROPHARYNGEAL PAIN (sore throat for 3 days) had resolved. At the time of the report, COVID-19 (positive for covid-19/ Had covid like symptoms), FATIGUE (Was extremely tired/  Still feeling tired) and HEADACHE (severe headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, SARS-CoV-2 test: other (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  No treatment medications were provided.
8 days post vaccine developed fever x 1 day then exanthem c/w Rubella
This case involved a female patient of unknown age who got body aches post vaccination (pain), while patient received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV]. 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 QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination. On an unknown date, the patient body aches post vaccination (pain), (latency: unknown) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. Details of laboratory data not reported. It was not reported if the patient received a corrective treatment. The event outcome was reported as unknown, at the time of reporting. There will be no information available on the batch number for this case.
Severe joint pain, nausea and vomiting on evening of shot.  Pain in joints for 24 hours.
Fever for 5 days; Chills; Migraine; Cough; Extreme dizziness; Loss of appetite; Nausea; Hives for one day; Rash several days later that lasted two weeks and counting; This is a spontaneous report from a non-contactable consumer, the patient. A 21-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 23Sep2021 at 10:00 (at the age of 21-years-old) as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome which was ongoing and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included metoprolol (MANUFACTURER UNKNOWN), isotretinoin (ACCUTANE) and loratadine (CLARITIN); all for an unknown indication from an unknown date and unknown if ongoing. The patient previously took ibuprofen (MANUFACTURER UNKNOWN) and experienced drug allergy. On 24Sep2021 at 15:00, the patient experienced fever for 5 days, chills, migraine, cough, extreme dizziness, loss of appetite, nausea, hives for one day; and then rash several days later that lasted two weeks and counting. The adverse events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of rash and included treatment with labs from an unknown date. Therapeutic measures were taken as a result of nausea and included treatment with unspecified medications. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event hives was resolved on 25Sep2021; while that of the event fever was resolved on 29Sep2021, after the duration of 5 days; and that of the events chills, migraine, cough, extreme dizziness, loss of appetite, nausea and rash were not resolved at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
dyspnea; rash; severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); This is a spontaneous report from a contactable other health professional (patient).  A 45-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: Ek5760, via an unspecified route of administration in the right arm, on 19Dec2020 17:00 at SINGLE DOSE for covid-19 immunization. The patient's medical history included urticaria and folliculitis: patient was under successful treatment for urticaria and folliculitis with near resolution. Concomitant medication included cefalexin (KEFLEX), cefdinir, fexofenadine hydrochloride (ALLEGRA), cetirizine hydrochloride (ZYRTEC) and triamcinolone. The patient received BNT162B2 on 19Dec2020. Then on 29Dec2020, 12:00, severe exacerbation (of urticaria and folliculitis) was observed after injection (both in first and second dose; 2>1); experienced rash and dyspnea requiring steroids and epipen. The adverse event resulted in a doctor or healthcare professional office/clinic visit. The patient's labs on an unknown date was negative for autoimmune disease. The patient was recovering from all events. Treatment for the events included Prednisone course, epipen, and H2 blockers.  No follow-up attempts are possible. No further information is expected. Information on the batch/lot number has been obtained.; Sender's Comments: Based on the temporal relationship and known safety profile of BNT162B2, the reasonable possibility of an association between rash, dyspnea and suspect product cannot be ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient presents to the ED with shortness of breath, cough, and congestion. She was admitted for covid evaulation and treated with remdesivir.
Patient received J&J vaccine on 3/5/21 and then received two Pfizer doses on 6/4/21 and 6/28/21 from 2142.  MIIC was not checked prior to Pfizer doses.
5min after vaccine as per  daughter, her mother began complaining of "burning " in her chest , itching in her throat, lump in her throat, hives/redness  noted on throat and chest. RRT responded and accompanied patient to ED
She stated that exactly 24 hours after receiving Prevnar 20 she started not feeling well. She stated that for 4 days she had a fever, chills, body aches, redness/swelling/itching at the injection site. She stated on 9/21/23 when I spoke with the patient that her arm is still swollen, red, and itchy.
Havrix vaccines / exposed to freezing temperatures since 13Apr2021 until 26Apr2021 / might have administered the vaccines after the excursion; This case was reported by a other health professional via call center representative and described the occurrence of product storage error in a patient who received HAV (Havrix) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In April 2021, the patient received Havrix and Havrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced product storage error. On an unknown date, the outcome of the product storage error 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 provided as follow: The reporter was a clinic manager. The age at vaccination was not reported. The Havrix was exposed to freezing temperature since 13th April 2021 until 26th April 2021, which leads to product storage error. The reporter stated that they might had administered the vaccines after the excursion, they were not sure at the moment of reporting. The reporter consented to follow up via email. No further information was reported.
Red, itchy, rash developed on left arm just below injection site. Also lumps formed under skin. Happened 8 days after injection.
soreness of arm was after taking the Pfizer first dose; Did not feel good at 3 weeks after receiving the first dose Adult Pfizer Covid 19 Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Type 1 Diabetes" (unspecified if ongoing), notes: She initially have Type 1 Diabetes, making her nervous to get 2 shots of COVID19 Vaccine; "Interchange of vaccine products", start date: Aug2021 (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: J&j vaccine (Dose 1), administration date: 06Apr2021, for Covid-19 immunization, reaction(s): "nauseous for a couple of days and did throw up", "first day the throwing up was self induced". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Aug2021, outcome "unknown", described as "soreness of arm was after taking the Pfizer first dose"; MALAISE (non-serious) with onset Aug2021, outcome "unknown", described as "Did not feel good at 3 weeks after receiving the first dose Adult Pfizer Covid 19 Vaccine". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: A week later in Aug2021, the patient had her first dose of Pfizer COVID-19 Vaccine. Caller mentioned that there was a small soreness on her arm during the first dose and Did not feel good at 3 weeks after receiving the first dose Adult Pfizer Covid 19 Vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Arm is sore; arm is red; arm is hard; arm is hard as a rock; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In July 2022, the patient received the 2nd dose of Shingles vaccine. In July 2022, less than a month after receiving Shingles vaccine, the patient experienced pain in arm, erythema of extremities, feeling of warmth and induration. On an unknown date, the outcome of the pain in arm, erythema of extremities, feeling of warmth and induration were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, erythema of extremities, feeling of warmth and induration to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 22-July-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient just had second shot and experienced arm was sore, red, hot, hard as a rock.  The patient stated that this would pass in a couple days, but the patient had her/his friends who had shingles. Additional supportive information: As it was reported that just had my second shot conservatively the vaccination date and event onset date was captured as partial and the time to onset was captured accordingly. The follow-up would not possible as no contact details were available.
Arm pain for 6 weeks, extreme pain with movement resulting in very limited mobility. I can barely remove a top, I am unable to reach for things or carry/pick anything up with that arm, which had no soreness at all before my shot.