chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Chills; slight fever; swollen lymph node; body aches; joint pain; shakes; headache; nasal congestion; clogged ears; This is a spontaneous report received from non-contactable reporter(s) (Nurse). The reporter is the patient.  A 24-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Jul2022 at 09:00 as dose 4 (booster), single (Lot number: FP4554) at the age of 24 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Ehlers-Danlos Syndrome" (unspecified if ongoing); "Mild cerebral palsy" (unspecified if ongoing), notes: Mild cerebral palsy; "Gastroparesis" (unspecified if ongoing); "known allergies: Latex" (unspecified if ongoing), notes: known allergies: Latex. Concomitant medication(s) included: LEXAPRO; BIOTIN; CETIRIZINE; TYLENOL; MOTRIN [IBUPROFEN]. Past drug history included: Prednisone, reaction(s): "Known allergies: Prednisone", notes: Known allergies: Prednisone. Vaccination history included: BNT162b2 (Dose Number: 3, Batch/Lot No: FE3590, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM, Route of Administration: Intramuscular), administration date: 21Nov2021, when the patient was 23-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM, Route of Administration: Intramuscular), administration date: 08Mar2021, when the patient was 22-year-old, for COVID-19 immunization; BNT162b2 (Dose Number: 1, Batch/Lot No: EL9262, Location of injection: Arm Left, Vaccine Administration Time: 06:00 PM, Route of Administration: Intramuscular), administration date: 15Feb2021, when the patient was 22-year-old, for COVID-19 immunization. The following information was reported: CHILLS (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering"; PAIN (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering", described as "body aches"; EAR DISCOMFORT (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering", described as "clogged ears"; HEADACHE (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering"; ARTHRALGIA (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering", described as "joint pain"; NASAL CONGESTION (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering"; TREMOR (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering", described as "shakes"; PYREXIA (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering", described as "slight fever"; LYMPHADENOPATHY (non-serious) with onset 08Jul2022 at 17:00, outcome "recovering", described as "swollen lymph node". Therapeutic measures were taken as a result of chills, pyrexia, lymphadenopathy, pain, arthralgia, tremor, headache, nasal congestion, ear discomfort. No follow-up attempts are possible. No further information is expected.
This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 2-month-old female patient who received HBV (Engerix B pediatric) (batch number 95SN2, expiry date 1st January 2022) for prophylaxis. Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis. On 5th January 2022, the patient received Engerix B pediatric and Engerix B Pre-Filled Syringe Device. On 5th January 2022, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 follows: Medical assistant reported that a patient received a dose of pediatric Engerix B that had already expired on 1st January 2022, which led to expired vaccine used. The reporter did not consent to follow up. The vaccine administration facility was same as primary reporter.
This spontaneous case, reported by other healthcare professional to VAERS and initially retrieved on 25-Sep-2018 by Seqirus from VAERS (VAERS ID: 737137), concerns an adult female patient of unspecified age. On an unspecified date in 2011, the patient was administered influenza vaccine (dose, frequency, route of administration, anatomical location, batch number, trade name, manufacturer and expiry date: not reported). On an unspecified date in 2011, after vaccination, the patient experienced anaphylaxis to flu vaccine (related). At the time of this report, the outcome of the event was not reported. This case (201804017) was cross-linked to the case: 201804016 (same patient).
This spontaneous report as received from a medical assistant referring to an adult patient of unknown age and gender. The patients' pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unknown date in 2017 (reported as: 06-APR-2017 to 08-NOV-2017), the patient was vaccinated with improperly stored doses of PNEUMOVAX 23 (dose, frequency and route of administration were not reported) (lot number M037669, expiry date: 09-MAY-2018) for prophylaxis. The PNEUMOVAX 23 was exposed to a total time in the range at or above 0 degrees C to 1 degrees C for 8.25 hours. It was reported the exact temperature and time below 0 degrees C was: -1.9 degrees C for 15 minutes, -1.2 degrees C for 15 minutes, -1.0 degrees C for 15 minutes, -0.8 degrees C for 15 minutes, -0.4 degrees C for 15 minutes and -0.2 degrees C for 1 hour 15 minutes. There was no previous temperature excursion. A "data logger" was involved. No product quality complaint (PQC) was involved. This is one of several reports received from the same reporter.
Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA 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 PYREXIA. At the time of the report, PYREXIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant information was not reported. Treatment information was not reported.   Reporter did not allow further contact
brother had his second covid shot on Monday put is not feeling well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (brother had his second covid shot on Monday put is not feeling well) in a male 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (brother had his second covid shot on Monday put is not feeling well). At the time of the report, MALAISE (brother had his second covid shot on Monday put is not feeling well) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Treatment medications were provided No  Concomitant medications were provided
Pt had fever & was given APAP p/vax given 920AM on 1JUL91; About 430pm had 1st convuls & @ 830PM 2nd one was rushed to Hosp by ambulance, but was seen by other MD on 1st convuls;
2-25-2009 at 6pm pt stated had nausea, lightheadedness and a fever up to 103 degrees.  2-26-2009 pt came to clinic left deltoid red,itchy,swollen and warm to touch.  Pt denies numbness, tingling and has full range of motion.  Denies other symptoms.
This retrospective pregnancy case was reported in a literature article and described the occurrence of preterm birth in a neonate of unspecified gender whose mother was vaccinated with DTPa (with small D & P), manufacturer unspecified). The subject's mother medical history included delivery by cesarean section. On an unspecified date, the 22-year-old mother of the subject received unspecified dose of DTPa (with small D & P) (unknown route and injection site). Her last menstrual period was on an unspecified date and estimated date of delivery was not provided. The neonate was exposed to the vaccine during unspecified trimester. On an unspecified date, after 36 weeks of gestation, the neonate was preterm born by cesarean section. No congenital anomaly was reported. The subject was hospitalised.
Received vaccine at primary care physicians office on 9/02/09.  Presented to Hospital on 9/04/09 with fever and leukocytosis.  Infectious disease physician attributed symptoms to a possible adverse reaction to the pneumococcal vaccine.  Offering symptomatic treatment and covering for community acquired pneumonia at this time.  9/24/09 Hospital records received DOS 9/4/09 to 9/10/09. Assessment: Pulmonary infiltrates/hypoxia, acute exacerbation of diastolic CHF, pneumonia, status post acute renal failure on chronic kidney disease stg 4. Patient developed tenderness at vaccination site followed by body aches everywhere and fever. Patient presented with increasing shortness of breath, chest tightness. Cardiomegaly.
This case was reported by a other health professional via sales rep and described the occurrence of generalized aching in a 64-year-old female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received SHINGRIX. In May 2018, 1 day after receiving SHINGRIX, the patient experienced generalized aching. On an unknown date, the outcome of the generalized aching was recovering/resolving. It was unknown if the reporter considered the generalized aching to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the physician's assistant (PA). The reporter stated that the patient called and said a day after she got Shingrix vaccine she got achey all over and she said she had been slowly getting better but it had been 3 weeks and she still had it. The reporter did not agree to follow up.
Patient received the Adult Pfizer Bivalent vaccine for those 12 years of age and older, rather than the Pediatric Pfizer Bivalent vaccine for those between ages 5-11. Patient was monitored for 15 minutes after the vaccine and did not show any signs or symptoms of an adverse reaction.
Injection site became red puffy and hot to touch, injection site became size of an egg and she went to the walk in clinic. Body temp was normal, injection site was 108
Left arm which is swollen; Left arm which is swollen and a little warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Left arm which is swollen) and VACCINATION SITE SWELLING (Left arm which is swollen and a little warm) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Apr-2021, the patient experienced VACCINATION SITE WARMTH (Left arm which is swollen) and VACCINATION SITE SWELLING (Left arm which is swollen and a little warm). At the time of the report, VACCINATION SITE WARMTH (Left arm which is swollen) and VACCINATION SITE SWELLING (Left arm which is swollen and a little warm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. No concomitant medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15 Jun 2021 included no new information.
Mild case of Shingles; This case was reported by a consumer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 months after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced shingles. The patient was treated with acyclovir. The reporter did not consen to follow up.
Patient received first injection on 01/21/21, second dose on 02/23/21 approximately June - July 2021 patient started to show generalized 1.5 to 2 cm erythematous flat lesions that would then become raised with fluid and after several days would subside leaving behind a hyperpigmented circular lesion that would be itchy. These would subside for several weeks and then recur again
Woke up with scattered red rash to chest/neck/back. Under breast and down into groin one large welt/hive with the sensation of a sunburn. So far have been on antihistamines for approx 14 hrs- rash is fading but burning itching sensation has not yet improved
Info has been been received from a registered nurse concerning a female PT who in approx 9/01 was vax'd w/a dose of Hep B vax recombinant. Concomitant therapy included hormones (unspec'd). Subsequently, the PT developed "multiple sclerosis type reactions" that were "probably not related to the vax", which included tingling and generalized weakness. The PT also developed pain in the inject site. The hormones (unspec'd) were changed to another hormone (unspec'd) and unspec'd medical attention was sought. As of 9/25/02 the adverse experiences had not abated. Upon internal review "multiple sclerosis type reaction" was determined to be an other important medical event (OMIC). Add'l info has been requested.
A patient who was 13 years old was given the pediatric pfizer (5-11) as opposed to the adult pfizer
Lymph node enlargement x 1 node, noticed the morning following vaccine administration. Lymph node in left axillary region. Slightly tender and very mobile; This is a spontaneous report from a contactable nurse, the patient.  A 30-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; ; Lot number:  EH9899), via an unspecified route of administration, in the left arm, on 22Dec2020 at 12:15 PM (at the age of 30-year-old) as a single dose for COVID-19 immunization.  Medical history included irritable bowel syndrome, anxiety, depression, allergies to dust, cats and dogs. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication taken within two weeks of vaccination included sertraline hydrochloride (ZOLOFT), melatonin, and l-theanine. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 23Dec2020 at 9:00 AM, the patient experienced lymph node enlargement x 1 node, noticed the morning following vaccine administration. Lymph node in left axillary region. Slightly tender and very mobile.  The event was reported as non-serious. On 29Dec2020 the patient underwent lab tests, which included SARS-CoV-2 test (nasal swab) and SARS-CoV-2 test (PCR, covid test): both of which were negative. The patient did not receive any treatment for lymph node enlargement x 1 node, noticed the morning following vaccine administration. Lymph node in left axillary region. Slightly tender and very mobile.  The patient reported that its still present 8 days later remains about 2 finger widths wide and is firm/dense, mobile, now nontender.  The clinical outcome of the event lymph node enlargement x 1 node, noticed the morning following vaccine administration. Lymph node in left axillary region. Slightly tender and very mobile was not recovered.
Pt recv vax on 11/19/98; on 11/25/98 pt exp Guillain-Barre syndrome
Patient experienced crushing chest/abdominal pain. Felt like "a large man was wrapping me up from behind". Pain subsided within 10-15 minutes. This pain was also experienced when she once received IV contrast dye before a CT scan.
Moderna COVID-19 Vaccine EUA Woke up at 4AM with a high fever (103F), arm/leg numbness and paralysis, nausea, vomiting, headache, and dizziness.  Numbness, paralysis, and vomiting only lasted about 15-20 minutes. Fever and headache lasted 18 hours from onset.
Mother positive, Sx onset 7/14/21 cough, sore throat, muscle aches, headache, fatigue, loss of smell & loss of taste.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On an unknown date in 2013, the patient was inoculated with ZOSTAVAX as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On an unknown date in 2014, the patient was treated in a medical center for a vesicular outbreak which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of events was unknown. Causality assessment was related. Additional information has been requested.
Red raised area, area felt hard lump, hot. Pt advised to take Benadryl, ice to area.
Had itchiness on left arm, began scratching it. Redness, warmth and swelling resulted from it.
Patient complained of feeling unwell the next morning (weak and fever of 103 F which lasted for 4 days) and started feeling pain in her arm.  During the next day her arm had some swelling  and on the 3rd day a rash that surrounded her bicep formed.    It is now 2 weeks later and she has mild soreness and the rash is still present.
This spontaneous report was received from a Registered nurse regarding a 13 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 23-JUN-2017, the patient was vaccinated with improperly stored dose of GARDASIL 9 lot# N004798 with expiration date: 31-OCT-2019 (dosing details and route of administration was not reported) for prophylaxis. No adverse effects were reported. The storage temperature was 47 degrees Fahrenheit to 77 degrees Fahrenheit (49F) and time frame was 14 hours. There was no previous temperature excursion. Digital data logger was involved. No product quality complaint was involved. This is one of the several reports from the same reporter. Sender's Comments: US-009507513-1804USA005153.
Upon waking up noticed a flat red rash on the arm that she got her H1N1 vaccine, no itching, no where else on her body. Goes up to her shoulder and down her arm. She also started to take Singulair 5 mg. that day after she was in for her vaccine. She had an appointment that day to see the doctor after she got her vaccine. Mother said she does have flare ups of allergy symptoms.
Mild dry cough beginning Wednesday (about 24 hours after vaccination) and becoming a moderate cough on Thursday into Friday, calming back into a mild cough later on Friday and nearly gone as of now (Saturday afternoon). Throat felt dry during the same period, leading to unusually high water intake and frequent urination, and briefly some discomfort and slight pain around the front-right part of waist that I assume was due to too much water and urination. Also Thursday night, I had some potential chills ? but no fever when I checked Friday morning. Also during this three-day period I felt fatigue, and lay in bed most of the day Friday. Also during this three-day period  I was congested and had a runny nose, but I have had those for weeks presumably due to allergies  Today I feel mostly but not quite healthy.
12 cm by 10 cm swelling and induration on L arm surronding the Kinrix injection site
Rapid heart rate (155bpm) for 20 hours  Nausea Dizzy  Chills Muscle weakness  Fever  Headache
Yesterday, 7/15/2021, a patient came in for an appointment she made to get her 2nd dose of her COVID-19 vaccine. The patient was larger, so I decided to use a 1.5" needle instead of a 1" needle. I administered the vaccine with an inject-safe barrier bandage over the injection site. I noticed a bit of blood after removing the needle, but no more than any other patient. I can ensure there was no injection solution left in the syringe after injection. The patient made no abnormal remarks after her injection, I asked her to sit in the chairs in front of the pharmacy for 15 minutes after the vaccine to ensure she did not have any reactions. The patient left without saying anything to any of us in the pharmacy. Today, 7/16/2021, I received a call from the patient today stating she thought that most of her vaccine leaked out of her arm. She said she noticed that her bandage was moist and fell off her arm before she left. She mentioned that she squeezed the bandage and large drops of red-tinged fluids were expelled. I explained to her that while that this may seem like a lot to her, that is likely not all vaccine fluid nor is it all of the vaccine. I told her I would do some research about whether or not a repeat dose would be necessary. After looking at CDC guidelines and discussing with several of my colleagues, I did not feel comfortable administering a repeat dose, so I called the patient and explained this to her. She said she understood, but would rather  on the side of caution and would rather be protected by the vaccine than not. I explained that this might not be the safest option, since I felt confident that she received the full dose and receiving an additional dose has not been studied. I then reached out to our district manager, and spoke with a clinical pharmacist at the home office, who all said since I was confident I gave the full dose that the patient would not need another dose. When I reached back out to the patient, she stated she decided she would reach out to her primary care physician Monday and then decide. I tried my hardest to convince her that she would not need another dose.
immediately following immun., child became limp, cyanotic, lasted 3 min followed by "staring" for approx 1 hr, as observed in MD's ofc, recovered completely & continued normal on phone, F/U & exam following day, DX: Prob vasovagal episode
Entire body ache ; Lethargic  The first day.  Severe rash below shot.  About 2x2 inch area    My Dr. prescribed steroid and moisturizer unless you have other solution
During 15 minute wait period after vaccine she reported her hands itching; she notified the observation nurse. Within the hour her right arm felt heavy, then progressed to her entire right side feeling heavy with numbness. Later she developed a migraine and noticed a rapid heart rate. By 1/31/2021 the symptoms began to lessen. Again on 2/3/2021 she experienced itching of her hands that progressed to itching all over her body, resolving after about 1 hour.
Patient received 1 dose of COVID-19 vaccine 1 week prior to presenting to ED with what turned out to be Lemierre's Syndrome. No recent head/neck infections, no burns to throat or mouth prior to Fusobacterium necrophorum bacteremia, IJV thrombosis, and empyema. Only new medication was 1 dose of COVID-19 vaccine ~ 1 week prior.
As soon as the needle was withdrawn a knot the size of a dime formed at the injection site.