chrisvoncsefalvay/vaers-outcomes huggingface dataset:
UTI; Patient had received third/booster dose 3, BNT162b2; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: 30145BA) via an unspecified route of administration in the left arm on 08Nov2021 at 11:30 (at the age of 54-year-old) as a single dose for COVID-19 immunisation. The patient had no medical history and known allergies to medications, food or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medications within two weeks of vaccination. The patient had previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 53-year-old) and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0176) via an unspecified route of administration in the left arm on 27Apr2021 (at the age of 53-year-old) as a single dose for COVID-19 immunisation. On 09Nov2021, the patient experienced urinary tract infection (UTI) after taking the booster vaccine. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of event which included treatment with an OTC AZO product and cranberry juice. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event UTI after taking booster vaccine was not recovered at the time of this report.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about late 2017, for routine health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster. On an unspecified date shortly after receiving ZOSTAVAX, the patient developed a painful rash. In response to these complaints, on an unknown date, the patient presented to a physician and was diagnosed as suffering from the shingles. The outcome of the events is unknown. As a direct and proximate result of these malfunctions, 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. Additional information has been requested.
Approximately  2-3mins after injection I felt intense shaking, trembling, chest and back pressure, numbness and tingling throughout my entire body, difficulty breathing, a burning sensation from the back of my throat down to the middle of my chest, an immediate need to move my bowels, nausea, bloated feeling, rapid pounding heartbeat, dizziness, light headedness, sinus pressure with a pounding headache with feeling like my head was going to explode and uncontrollable stuttering and jumbled speech. I had a feeling of imminent death.
Fever, anxious.  Tylenol given.  Symptoms resolved after 24 hours.
COVID-19; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62-year-old male patient received BNT162b2 (BNT162B2), on 08Nov2021 as dose 3 (booster), single (Lot number: 32030BD) at the age of 62 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Psoriatic arthropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown result, notes: Covid rebound after Paxlovid treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Redness, swelling and pain @ injection site and syncopal episode resulting in injury to face.
Information has been received from a registered nurse concerning a 32 month old who on 25-AUG-2006 was vaccinated with 0.5 ml of VARIVAX (Merck) (Lot # 652667/1035R). On 30-MAR-2008 the patient developed a chicken pox rash and vesicles, with over 100 lesions. It was noted that the clinic was contacted, but it was unspecified if medical attention was sought. There was no product quality complaint. At the time of reporting the patient was recovering. No further information is available.
Stomach cramping, diarrhea, nausea for 1 1/2-2days. No specific treatment other than fluid replenishment. Recommended to contact Dr. if continues >72 degrees or unable to maintain fluids.
Started redness and swelling 2/8. Continued to get worse through today 2/10. Still red and swollen and now have another red (welp looking spot similar to shot site) close to my shot site. Redness stated about a cone meter in diameter. It?s ow at about an inch and a half. Super itchy and painful.  Was told to report if it got worse within 24-48 hours.
Fibromyalgia; Arm Pain - Near Injection Site/ Soreness - Near Injection Site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of FIBROMYALGIA (Fibromyalgia) and VACCINATION SITE PAIN (Arm Pain - Near Injection Site/ Soreness - Near Injection Site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia. Concomitant products included ALPRAZOLAM, OXYCODONE HYDROCHLORIDE (OXYCONTIN), OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]), GABAPENTIN, MIRTAZAPINE, ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN LOW) and METOPROLOL for an unknown indication.    On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm Pain - Near Injection Site/ Soreness - Near Injection Site). On an unknown date, the patient experienced FIBROMYALGIA (Fibromyalgia). At the time of the report, FIBROMYALGIA (Fibromyalgia) and VACCINATION SITE PAIN (Arm Pain - Near Injection Site/ Soreness - Near Injection Site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment medications provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: Follow up received on 23APR2021, patient stated that she is in hospital and rehab after 1st dose and updated the 2nd dose details and states she fell a lot of additional pain.
About 6 hours after the injection, Patient's neck and shoulders started twitching.  Twitching lasted about 2 hours then started to slow down in frequency, until it stopped.  This symptom returned the next day, but not as severe.  She also had joint and muscle pain throughout her body the first evening. Ice and pressure on the areas seemed to help.  For the two days following, Patient had stomach pain and headaches.  All symptoms seem to have subsided.  The booster shot should be super fun!
Breakthrough case after 4 vaccines Pfizer 2/2/21 Lot# EM9810;  Pfizer 2/23/21 Lot# EN6202;  Pfizer /7/2 Lot# FL3197;  Pfizer 5/11/22 Lot# FK9894
Vaccination site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Vaccination site pain) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 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 started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. In August 2021, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). In 2021, VACCINATION SITE PAIN (Vaccination site pain) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.   The patient did not think Skyrizi was working as well as he expected. After taking his Covid 19 Vaccines he only felt a sore arm for a couple of days after both injections in Aug 2021. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   Primary reporter did not have the lot number information, because the packaging was discarded.   No treatment information was provided.  This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Patient received the vaccine and about 5 minutes later reported feeling very dizzy. Was given some water to drink. A few minutes later she reported a tingly sensation all over and mild tightness in her chest. Was given a Benadryl. About 10 minutes later the patient became unconscious, was still breathing. EMS was contacted and came and transported to ER
Fever, NauseaVomiting, right arm heaviness and swelling, sweaty Narrative:  Other Relevant History:
Patient received a dose of Moderna vaccine from and expired vial,  a vial which had also been punctured  (more than 12 hours).; a vial which had also been punctured on 30Jan2022 (more than 12 hours).; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose of Moderna vaccine from and expired vial,  a vial which had also been punctured  (more than 12 hours).) and PRODUCT STORAGE ERROR (a vial which had also been punctured on 30Jan2022 (more than 12 hours).) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Feb-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose of Moderna vaccine from and expired vial,  a vial which had also been punctured  (more than 12 hours).) and PRODUCT STORAGE ERROR (a vial which had also been punctured on 30Jan2022 (more than 12 hours).). On 01-Feb-2022, EXPIRED PRODUCT ADMINISTERED (Patient received a dose of Moderna vaccine from and expired vial,  a vial which had also been punctured  (more than 12 hours).) and PRODUCT STORAGE ERROR (a vial which had also been punctured on 30Jan2022 (more than 12 hours).) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Most recent FOLLOW-UP information incorporated above includes: On 07-Feb-2022: Follow-up contain fax no which is added.
1st dose on 26-Jan-2021 & 2nd dose on 07-Sep-2021; spiked a fever of 101F within 6 hours of the dose, & it lasted for 2 & half days; felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise; felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise; had very, very strong reactions to these vaccines; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise), PAIN (felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise), IMMUNISATION REACTION (had very, very strong reactions to these vaccines), PYREXIA (spiked a fever of 101F within 6 hours of the dose, & it lasted for 2 & half days) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 26-Jan-2021 & 2nd dose on 07-Sep-2021) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 028L20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced MALAISE (felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise), PAIN (felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise) and IMMUNISATION REACTION (had very, very strong reactions to these vaccines). On 07-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 26-Jan-2021 & 2nd dose on 07-Sep-2021). In September 2021, the patient experienced PYREXIA (spiked a fever of 101F within 6 hours of the dose, & it lasted for 2 & half days). At the time of the report, MALAISE (felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise), PAIN (felt really crappy for 5 days/felt crappy for 4 days with body aches & malaise) and PYREXIA (spiked a fever of 101F within 6 hours of the dose, & it lasted for 2 & half days) had resolved and IMMUNISATION REACTION (had very, very strong reactions to these vaccines) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 26-Jan-2021 & 2nd dose on 07-Sep-2021) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2021, Body temperature: 101 101 F.         No Concomitant medication was reported. The patient waited so long between the 1st & 2nd doses to make sure it wasn't an allergic reaction.Patient did not had Covid as far as patient knows.  No Treatment medication was reported   This case was linked to MOD-2022-600694, MOD-2022-600690 (Patient Link).
Injection site erythema; Rash vesicular Information received from a health professional concerning a 26 year old female who on 24-JAN-2006 was vaccinated with a 0.5ml subcutaneous dose of varicella virus vaccine live (Oka/Merck) (Lot#652084/0944R). On 02-FEB-2006 the patient developed redness at the injection site and 2 vesicular lesions on her trunk. No other symptoms were noted. At the time of the report the patient was recovering. Unspecified medical attention was sought. No product quality complaint was involved. No other information was provided. Additional information has been requested.
Swelling in left elbow, not painful, very soft, feels like fluid.; This is a spontaneous report from a contactable consumer, the patient. A 54-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0161) via an unspecified route of administration in the left arm on 17Apr2021 at 11:00 (at the age of 54-years-old) as a single dose for COVID-19 immunisation. Medical history included food allergy (Corn) and penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. Concomitant medications were not reported. On 19Apr2021 at 11:00, the patient experienced swelling in left elbow, not painful, very soft, felt like fluid. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event swelling in left elbow, not painful, very soft, felt like fluid was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
sore throat, severe cough, severe pain inner thighs, severe pain both shoulders, sciatica right leg
pt recv vax 13SEP95 & 9MAY97 pt devel a mild case of chickenpox;
four minutes post administration- chest tightness @ an 8 (0-10 scale, 10 greatest discomfort/pain) of discomfort, chest and abdomen hives with itchiness. One hour post administration left side throat and ear pain (pain was a 6 )with swelling possibly to lymph node ( lasted 37 hours post administration). Hives and itchiness continued for 43 hours post administration.  I did orally take 25 mg of Diphenhydramine 30 minutes prior to administration of the vaccine. Once symptoms begin I was advised to orally take 50mg of Diphenhydramine and wait 30 minutes for further observation. I continued to take my daily medications as directed and Diphenhydramine 25mg as needed for the itchiness and hives.I did inform my primary care provider and allergist of my reaction, both physicians advised me to not have the second dose administered. I followed their directive and I did not have the second dose of Moderna administered in January.
Noticed eyes were swollen almost shut, 3 days, post vax. Lips were also swollen. Took Benadryl and went to work. Red blotches developed on face. Over the next several days, hands and toes began itching and more blotches appeared on back, torso, buttocks and legs. Tongue was swollen on 10/30/00 and throat sore and swelling. Saw MD on 10/31/00 and prescribed Zyrtec and Prednisone. Pt felt better later that day.
Pt was sore. parent Noticed Swelling and a rash or redness go down arm. No fever.Pt took Tylenol and motrin and they even did Benadryl to help with the swelling and rash. The redness measured 6 in long and 5 in across pt upper arm.
I contracted COVID 19 after receiving all 3 doses of the COVID 19 vaccine. I had a breakthrough case. I developed a severe cough and low grade fever for at least a week. I went to see the doctor after 4 or 5 days on December 01, 2021. She checked all my vitals and tested me for COVID 19 with a PCR test and the results were positive. It took a dew days for the results and I received a call from the doctor. She advised that if I did not improve I could receive the antibodies via infusion on December 06, 2021. I still had fever for a few days and coughing for a few days. It took me close to a month to recover. It was mostly being tired with a low amount of energy.
Dry mouth, dizziness and throat tightness. Benadryl 25 mg oral administered by . Pt was observed for an additional 30 min, symptoms improved. Pt discharged home.
Later in the day after receiving the vaccine developed burning pain along entire spine followed by generalized muscle pain in back. Self treated with Robaxin and Motrin. Pain persisted for approximately 18-24 hrs.
Early afternoon - Tiredness- 7-8 pm Fever of 99; Muscle/joint aches/pains; Upset stomach; stuff nose Later in evening - hives Next morning - swollen lip on left side (had derm filler on 1/21/2021)  Took Tylenol and Benadryl
Transient Global Amnesia -lasted approximately 6 hours .  Woke up that morning with a migraine and took one prescribed migraine pill.  I ran a temperature the evening of Sept 20 and had painful joints until 11:00 am on Sept 21
pt recv vax 18FEB97 & 19FEB97 pt devel a gen urticaric rash & was given DPH;the rash was described as an allerg rxn;
INFLAMED TOOTH ROOT PRESSING AGAINST JAW BONE; TOOTH INFECTION; This spontaneous report received from a patient concerned a 42 year old male. The patient's weight was 190 pounds, and height was 70 inches.  The patient's past medical history included bridge for 9 years no issues, and concurrent conditions included cigarette smoker five cigarettes per day, and non-alcohol user, and other pre-existing medical conditions included the patient had no known allergies.  The patient had no history of drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808986, and expiry: unknown) at a frequency one total, dose was not reported, administered on 26-JUN-2021 for prophylactic vaccination on left arm.  No concomitant medications were reported.  On 10-JUL-2021, the subject experienced tooth infection. On an unspecified date, the subject experienced inflamed tooth root pressing against jaw bone. Patient visited urgent care were received antibiotics and steroids for pain.  On 14-JUL-2021 patient had removal of bridges.  Patient oral surgeon had suggested surgery for inflammation. on 15-Jul-2021, Patient will have extraction of 2 teeth associated with the events.  As of 14-Jul-2021, the patient stated that the past 5 days of pain have been unbearable regardless of the medications received. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from inflamed tooth root pressing against jaw bone, and the outcome of tooth infection was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20210730837 - Covid-19 vaccine ad26.cov2.s - Tooth infection. 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.
Right arm hurting from shoulder to elbow; Burning sensation on the left arm; Shoulder pain on the left arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm hurting from shoulder to elbow), BURNING SENSATION (Burning sensation on the left arm) and ARTHRALGIA (Shoulder pain on the left arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (Right arm hurting from shoulder to elbow), BURNING SENSATION (Burning sensation on the left arm) and ARTHRALGIA (Shoulder pain on the left arm). At the time of the report, PAIN IN EXTREMITY (Right arm hurting from shoulder to elbow), BURNING SENSATION (Burning sensation on the left arm) and ARTHRALGIA (Shoulder pain on the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medications were reported.
Received shot 7/25/07. Immediate redness and swelling noted by bedtime had 3 inch red raised area with large site on 7-27-07. Gradually has gone down. 7-30-07 no longer raised or red, but c/o itching and pain at site.
My husband got sick first and so I felt fine for a few days, but then I woke up ill. On December 8, 2022, I took a test, and it was positive. I got prescribed Paxlovid on December 9, 2023. I had very bad flu like symptoms with a fever, vomiting, very tired, and coughing a lot. I started feeling better about a week and a half later, and fully recovered by December 27, 2023. I still have not regained all my sense of smell.