chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a nurse regarding a 14-month patient of an unknown gender. The patient's concurrent conditions and medical history were not provided. On 14-JAN-2019, the patient was vaccinated with an improperly stored dose of VARIVAX (route of administration and dose were not reported) for prophylaxis (lots # and expiration dates: R018777, 01-JUL-2020; R017641, 20-JUN-2020; R013563, 13-MAY-2020), however, it was unknown which specific lots the patient received. The Sterile Diluent used to reconstitute the vaccines was stored properly. No adverse effects were reported. The vaccines were exposure to a temperature excursion of 9°C to 25°C (9.2°C) during 2 hours which was called by a data logger. There was not previous temperature excursion. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1901USA005741: US-009507513-1901USA005740: US-009507513-1901USA005743: US-009507513-1901USA005739:
1/2hr p/shot given, infant began crying a high pitched cry intermittantly for 3-4hrs; mom denies unusual swelling or a fever; mom took infant to MD  no tx given;
my left hand and my foot swell; my left hand and my foot swell; I had the temperature almost like I got the flu; my head is really hurting; Body hurting; I feel disoriented; it is not working; It started in the area where they shot me and then it became my entire arm and then my whole body just hurt though; I am cold but like I am hot really hot. I felt like I am burning up; This is a spontaneous report from a contactable consumer or other non hcp. A 58-years-old female patient received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 07May2021 (Batch/Lot Number: EW0160; Expiration Date: 31Aug2021) as second dose single for COVID-19 immunization. Historical Vaccine of BNT162B2 was received as a first dose on an unspecified date. Medical history included diabetes mellitus, infectious thyroiditis from an unknown date and unknown if ongoing. She stated, takes medicine for diabetes and thyroid medication. I have been taking the medication for the past, it's been some years now. Concomitant medications with paracetamol route of administration, start and stop date were not reported for an unspecified indication. The patient experienced my left hand and my foot swell (hand swelling and swelling of feet), had the temperature almost like she got the flu, my head is really hurting, body hurting, she felt disoriented, it is not working, it started in the area where they shot me and then it became my entire arm and then my whole body just hurt though, I am cold but like I am really hot. I felt like I am burning up on an unspecified date. Consumer stated, she took Tylenol, and she work for the government. A lot of medical workers do. A nurse said you take Tylenol. So, that's what I have been taking but it is not working. She stated, there was no need to have any treatment. I got the vaccine. I came home. I lay on the bed yesterday when I left there so, it was just started hurting. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Myalgia and "Flu" like symptoms, Papillar skin rash on abdomen and thighs 24-48 hrs post vac administration.  No fever.  Symptoms resolved 72 hrs post vaccination.  No treatment given.
NAUSEA, VOMITING, FEVER, HEADACHE, COUGH. BODY ACHES
ACHY; CHILLS; SLIGHT FEVER; This spontaneous report received from a patient concerned a patient of unspecified age and sex. 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 not reported, batch number: UNKNOWN expiry: UNKNOWN) 0.5 ml, administered on 05-MAR-2021 for an unspecified indication. The batch number was not reported. The company is unable to perform follow-up request to batch/lot numbers. No concomitant medications were reported. On 05-MAR-2021, the subject experienced chills. On 05-MAR-2021, the subject experienced slight fever. On 06-MAR-2021, the subject experienced achy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the slight fever, chills and achy was not reported. This report was non-serious.
9/11/21-9/12/21: severe right abdominal pain, nausea, and chills 9/12/21-9/15/21: hospitalization; CT scan of abdomen and pelvis showed "severe right hydronephrosis". Patient underwent cystoscopy surgery with right ureteral stent placement. 1/17/22: patient underwent dismembered pyleoplasty to repair ureteropelvic junction obstruction. 1/17/22: Final diagnosis of tissue exam: "A. Right ureteropelvic junction, excision: benign ureteropelvic junction with severe acute inflammation" F/U in 3-6 months for US Retroperitoneal Limited and and NM Kidney Morphology Vasc Flow Function exams and urology check-up once a year afterwards
2-17-21 mid after noon started experiencing fever, cold sweats, fatigue. Took advil and states it helped. reports light headedness, advised that is not common and should get seen at an urgent care to r/o other potential causes.
I am confined to my bed for a large part of the day. It is hard to do my daily activities. I am 27 weeks pregnant currently. After the first dose of the vaccine, I had a burn like rash on my upper lip. It burned and I had red patches on my upper lips. I had been on antibiotics, but I do not have lip fillers or anything. The day after the vaccine I had really bad, body aches and severe joint pain. It was my entire body every muscle and every joint. It was a little better the next day but on the second day my back was really sore. I am currently on muscle relaxers and narcotics, but the pain is really bad.  Currently back pain is on the left side between my tailbone and my hip. I have had a problem with a torn muscle in that area during a previous pregnancy. I did not have any issue with my back during this pregnancy before the vaccine. I have been doing some physical therapy. I am very limited in my activities and on bed rest for most of the evening after the pain gets too bad. There has been no problem with the baby so far. Due Date 07/04/2021 Seventh Pregnancy- Fifth Pregnancy.
Itching of face after vaccine. ER visit with dx hives, otitis media. Discharged 8/2/07 at 5:35pm. Medrol-dose pak and Zithromax.
Information has been received from a physician concerning a 4 year old male with no known allergies or pertinent medical history who on 8/30/06 was vaccinated SC in the right arm with a 0.5ml dose of Varicella vaccine (lot 648315/0072R). Concomitant vaccination included a dose of MMR II, a dose of Polio vaccine, and a dose of Dtap. Two weeks after immunization, on approx 9/13/06 the pt developed weakness of the right arm. Medical attention was sought. An X ray of the right arm was performed and was within normal limits. Labs performed included, creatinine kinase, complete blood count, and sedimentation rate, results pending. At the time of the report the pt had not recovered. There was no product quality complaint involved. The right arm weakness was considered to be disabling. Additional information has been requested.
No adverde effect were reprted; A patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, previous drug reactions, allergies and concurrent conditions were not disclosed. The concomitant therapies included sterile diluent (it could not be determined if it was properly stored).  On an unknown date, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck) (VARIVAX) administered subcutaneously for prophylaxis (strength, dose number, frequency and anatomical injection site were not reported), lot # S015460 and expiration date 20-MAY-2021.  On 15-OCT-2019, it was noticed that this vaccine had been on a temperature excursion and was stored at minus (-) 11.5 degrees Celsius during 76 hours; but it was also noted that there had not been a previous temperature excursion.  At the time of this report, there were no adverse events reported. Digital data logger was involved.
Patient fell to the floor 7 minutes after receiving the vaccine. He was monitored and placed on his side then back to facilitate breathing. The patient was unresponsive for 10 seconds and unable to respond to commands. The patient regained consciousness after 10 seconds  and was responsive to commands. Initial assessment identified a small abrasion to his left sagittal head with a complaint of a headache. Patient was placed in a sitting position with monitored vitals identified as stable. He denied neck/back pain, numbness or extremity tingling. Vital signs remained stable and patient refused treatment or transport to another facility.
I began having period symptoms and started my period a couple days before I was expected to. I've always had extremely regular periods so this was uncommon. This period was also unusually heavy and my period symptoms were much worse than normal.
This spontaneous report was received from a female patient who at the time of the report was 68 years old and was reporting regarding herself. No medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with the first dose of RECOMBIVAX HB (dosage, frequency, route of administration, lot# and expiry date were not reported). Following vaccination, the patient experienced "aching all over her entire body for 1 week". Then, on an unknown date, after receiving the first dose of the vaccine, the patient was vaccinated with a second dose of RECOMBIVAX HB. Subsequently, the patient stated that she developed difficulty swallowing and was "unable to speak". The patient also stated that she sought medical attention and was administered with EPIPEN as treatment on an unspecified date following the occurrence of the events of dysphagia and aphasia. The outcome of aphasia and dysphagia were unknown but the patient recovered from the pain. No causal relationship was stated between the events and vaccination with RECOMBIVAX HB. Upon internal review, the event of aphasia was considered to be medically significant. Additional information has been requested.
Soreness at injection site. Headache and body aches  and fatigue. I had Covid and still have antibodies so I think this made my reaction worse than others.
Pneumococcal vaccination given on 2/22/09 @ 1000.  The patient did not experience any symptoms until 2/23 when she noticed her Left Deltoid was hot, raised and began to itch.  Benadryl was given on 2/23 at 2300 and the redness continued to spread to approximately a 4x4 area. By 1500 on 2/24 the deltoid was still raised and somewhat hot but the swelling had decreased to about 3 x 3 and did not itch.  A second dose of benadryl was given at 1500 due to some discomfort.
Case number PHEH2015US018401 is a spontaneous report initially received from a nurse on 15 Sep 2015. This report refers to a 51 year old male patient. Past medical history and concomitant medications were not reported. The patient's vaccination history included seasonal influenza vaccine (manufacturer and batch number: not reported) on an unknown date in 2015 which was tolerated well. The patient was vaccinated with initial dose of FLUCELVAX (batch number: 006011A) at a dose of 0.5 ml intramuscularly in the left deltoid on 11 Sep 2015 which was of season 2013/2014 and the vaccine was outdated. The reporter enquired how to proceed with this year's flu vaccine. No adverse event occurred following the maladministration (expired vaccine used). Follow up information received from a nurse on 28 Oct 2015: Updated patient demographics (initial, date of birth, age, gender, height and weight), suspect vaccine was coded from influenza unknown to FLUCELVAX, dose, route, site, vaccination date and batch number of suspect vaccine and vaccination history.
Information has been received from a nurse concerning a patient over the age of 60 years, who on 11-JAN-2007 was vaccinated intramuscularly with Pneumovax 23 (lot # 655591/0886F). Subsequently, on an unspecified date, the patient developed injection site redness, swelling, and warmth. Unspecified medical attention was sought. The patient subsequently recovered from the injection site redness, swelling, and warmth. Additional information has been requested.
I experienced after my J&J vaccine, pain to my left hip, left wrist pain, felt like I had broken it and I had difficulty lifting a glass of water. On the following day I developed a rash on my face, head and neck which lasted two weeks . I saw a PCP for my rash and gave me pills to take for 5 days.  As of today my symptoms have resolved.
There is a large area around the injection site that has gotten red and slightly swollen and a little warm to the touch but not painful at this time
3/10/2021  right knee swollen and extremely painful.  This was first call to dr.   Ok after few days. Then, 3/10 knee, 3/23 hip, 4/2 right pointer finger swollen extreme pain, 4/4 neck limited range of motion.4/8 -4/14 left shoulder. 4/16 start  800 mg ibuprofen. 4/16 red patch back of hand. 4/20 right shoulder pain unable to hold steering wheel. No range of motion. Start one week prednisone . Sent to Rheumotologist. Start with 40 mg. 4/23 right foot toes swollen and ache. 5/1 swollen left ring finger but no pain. 5/2  swollen right ankle no pain. 5/2 swollen left hand fingers and red patch extreme pain and no sleep.800 mg ibuprofen and etodolac no help. 5/16 left hand again swollen extreme pain. 5/22 left hand. 5/25 right hand. 5/27 shoulder,.  6/4 feet.
The patient received in his second dose receive Pfizer 5 to 11 years covid vaccine and had to be Pfizer 12+ covid vaccine
Less than 1 day after, started with welts.   Progressed in size and numbers.  Still getting more today, 7 d later. Largest welt on arm is about 10 x 6 cm.  A second is about 5x4 cm. Several smaller ones.
Patient started expirencing symptoms the night of 6/25/21 after recieving vaccine the same day. Symptoms include headache and rash/hives with itching.
had a tumor on his neck; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM (had a tumor on his neck) 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM (had a tumor on his neck). At the time of the report, NEOPLASM (had a tumor on his neck) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported by reporter. No treatment medication reported by reporter.
Patient complained of dizziness, nausea, lightheadedness, fast heart rate, brief lost of vision, trouble breathing. EMS 911 was called and provided services to the patient for an hour. Patient went home as advised by EMS.
fatigue, general aching, dull headache, sore injection site, injection site induration, nausea - Lasted through the following day until evening
Slight sore throat; Slight fever; Slight headache/headache; I work, there were 2 women who work in my classroom. Who have tested positive for Covid.; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot: EL3247) on 20Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. Patient got the vaccine on 20Jan2021 and had a headache during the day (on 20Jan2021). On 21Jan2021 had a slight sore throat; patient had a slight headache and a slight fever. Patient did not know if it was side effect or if it was Covid. Patient also stated that there were 2 women who work in patient's classroom, who have tested positive for Covid (Jan2021). Patient would like to know if she should get tested or if it was just normal side effect. Final outcome of the events was unknown.
ACHES; CHILLS; This spontaneous report received from a patient via a company representative concerned a 21 year old. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 08-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 08-APR-2021, the subject experienced aches. On 08-APR-2021, the subject experienced chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from chills, and aches. This report was non-serious.
This spontaneous report has been received from a medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 06-JUN-2017, the patient was vaccinated with expired dose of M-M-R II injection, lot # L009212, expiration date 17-MAR-2017 (dose and route of administration were not reported). The vaccine was reconstituted with sterile diluent (DILUENT MRK) (dose, route of administration, lot # and expiration date were not reported). No symptoms were reported. No product quality complaint was involved. The reporter did not want to provide a physician's name but said that a follow-up form can be sent to the office and did not want to identify to whose attention the follow-up form should be sent to. Additional information has been requested.
pt recv vax 19JAN98 & 27JAN98 pt exp a fever & on 28JAN98 devel a measles-like rash on back & upper trunk;also exp erythematous tympanic membrane & diarrhea;
has been sick; is under 18 years old and received a shot of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (is under 18 years old and received a shot of the Moderna vaccine) and ILLNESS (has been sick) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Jul-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (is under 18 years old and received a shot of the Moderna vaccine). On an unknown date, the patient experienced ILLNESS (has been sick). On 26-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (is under 18 years old and received a shot of the Moderna vaccine) had resolved. At the time of the report, ILLNESS (has been sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant drug details were reported. No treatment details were reported.
Severe red eyeball and face swelling. Headache, body aches and fever. Lasted 36 hours
PT also received Hep A, TDaP and flu vaccines.  Pt related hx of alpha-gal allergy.  Discussed with pt that while MMR vaccine contained a small amount of gelatin in it, it was not contracindicated for patients with alpha-gal allergy.  We had pt remain in clinic 15min post vaccination and he reported feeling fine.  Advised pt to continue to monitor for s/sx of reactions.  Pt called Health Department and reported that he thought he might be having an allergic reaction to the vaccines.  He stated that he had a red rash that wasn't raised yet but appeared like hives that was around his waist, legs, arms and hands that was itchy.  He stated that he had taken 50mg of Benadryl, what he had previously done when he had symptoms from his allergy.  Pt was advised to call his PCP for further advice and to then proceed to the ED to insure that the allergic reaction did not increase.
Pt admitted to Medical Center, on 4/17 with worsening SOB x 3 days, he was going to have extensive Bilateral saddle pulmonary embolism.
Patient received COVID-19 vaccination on 1/18/2021.  Patient has no issues immediately after vaccination. However 10 minutes after patient came back and explained she felt her face was breading out. Gave the patient benadryl at this point the patient then reported that she felt a little dizzy and light headed.  Explained to patient to wait in chair to see if reaction would become worse.  At which point offered the patient water.  Checked up on patient 5 minutes later and patient explained she was feeling better with no more issues. Explained to patient if she feels worse to contact us or doctor's office.
hosp for whooping cough was dx w/whooping cough w/lab test-positive for pertussis;
Patient received the first Shingrix dose a year ago and did not received the second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 1 year ago prior to the reporting).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Patient received the first Shingrix dose a year ago and did not received the second dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 14-JUN-2023 The reporter wanted to know if patient can receive the second dose or the patient need to restart the doses. The reporter did not provided patient information age, gender or initials nor the information about the first dose of Shingrix vaccine lot number, expiry date and date of administratiion The reporter did consent to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination.
Chills; fever; extreme fatigue; muscle achiness; headache; swollen arm; rash on arm; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female patient received 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot#: EN6202, expiration date unknown) on 23Feb2021 at 12:15 AM at the age of 70-year-old at single dose via an unspecified route of administration at left arm for COVID-19 immunization. Patient was not pregnant at time of event and at the time of vaccination. Medical history included allergy to sulfa. Patient previously received 1st dose of BNT162B2 (Lot#: EL9264) on 02Feb2021 at 02:00 PM at the age of 70-year-old at left arm for COVID-19 immunization. Concomitant medications included raloxifene, fish oil, ergocalciferol (VIT D) and calcium. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient experienced chills, fever, extreme fatigue, muscle achiness, headache, swollen arm, rash on arm; all on 23Feb2021 at 15:00. Outcome of the events was recovering. No treatment was received for the events. Events were reported as non-serious. Events didn't result in emergency room visit or physician office visit. No seriousness criteria was reported: no results in death, no life threatening, no caused/prolonged hospitalization, no disabling/Incapacitating, no congenital anomaly/birth defect. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19.