chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Adverse event: Two days after first injection, both eyes swollen, hurt to touch and inflamed.  Blared vision in left eye. Previously had derma filler in 2017/2018.   Treatment: Benadryl, Tylenol, cold packs Outcome: visited PCP on  5/24/2021,  still recovering
Developed fever to 102.7, fussiness, decreased nursing and bulging fontanelle after having been seen that morning for Well Infant Care and receiving vaccines.  Seen in ED, had full septic work-up.  Admitted for observation, antibiotics sending cultures. 8/19/08-records received for DOS 4/25-4/28/08-DC DX: Observation for suspected infectious condition. Bulging AF and fever. Presented to ED with fever and bulging anterior fontanelle. Temp 101.2, fussy and crying. CT normal.
Episodes of bright red Bleeding in stool; internal small hemmoroid; This is a spontaneous report from a contactable consumer (patient). A 52-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ER8730), via an unspecified route of administration in left arm on 20Apr2021 at 09:00 (at the age of 51-years-old) at dose 1, single for COVID-19 immunization. There was no medical history. The patient was very healthy. Prior to vaccination, she was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. Concomitant medications included ascorbic acid (VITAMIN C), vitamin D3, menaquinone-7 (K2), zinc, and magnesium. The patient previously took prednisone and experienced allergies. She did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was reported as pharmacy or drug store. Since the vaccination, the patient has not been tested for COVID-19. On 14Jul2021 at 08:00, the patient experienced episodes of bright red bleeding in stool. She had a colonoscopy which showed an internal small hemorrhoid but there was no bleeding at time of colonoscopy. She has regular bowel movements and eats whole foods, no sugar, and gluten diet for 21/2 years. She was very healthy and had great blood work at the time of colonoscopy on 20Jul2021. The doctor who performed the colonoscopy said there were no other issues. The events required emergency room/department or urgent care visit. She did not receive any treatment in response to the events. The outcome of the events was unknown.   Follow-up attempts are completed. No further information is expected.
arm was really sore; Initial information received on 09-Dec-2019 regarding an unsolicited valid non-serious case received from a consumer.  This case involves female patient (age not reported) who experienced really sore arm (Pain in extremity), while she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 02-Dec-2019, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via intramuscular route in the left arm.  On an unknown date, the patient developed a non-serious arm was a little sore (Pain in extremity), unknown latency following the administration of INFLUENZA VACCINE. It was reported that her arm was a little sore the first day. On day 2, she reported that her arm was really sore, causing her concern.  Other relevant tests not reported.    Final diagnosis was Pain in extremity.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for Pain in extremity.  Information on the batch number was requested.
Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder); Administration of vaccine adjuvant suspension component (liquid) without active antigen (powder); This case was reported by a physician via sales rep and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-JUN-2022 and 29- JUN-2022 Reporter's Comments: This case was related to patient 5 of the 5 patients mentioned in case narrative. The GlaxoSmithKline sales representative called GlaxoSmithKline response center the morning of 29th June 2022 to report that the previous day late in the day he was at a medical office and was shown a box of Shingrix. The box had 5 vials of the adjuvant missing.  The sales representative asked what happened to the vials.  The response that was given was that they were administered to 5 patients. No further information was gathered by sales representative such as lot number, patient's initials, patients genders, or route of administration. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up. Additional Supportive Information: The patient was administered vaccine adjuvant suspension component (liquid) without active antigen (powder) component which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. This is 1 of the 5 cases reported by the same reporter. The case US2022AMR100445 was identified as duplicate of US2022101093. The case US2022101093 would be voided, and all the future correspondence would be added in this case US2022AMR100445 which stands as a case of record for this patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022099857:Same reporter US-GLAXOSMITHKLINE-US2022AMR100447:Same reporter US-GLAXOSMITHKLINE-US2022AMR100449:Same reporter US-GLAXOSMITHKLINE-US2022AMR100452:Same reporter
I received my Moderna booster for COVID-19 on 12/29/2021. On 5/21/2022, I started coughing and had a fever (temperature unknown), severe headache, sinus congestion, and chills. The chills and fever lasted for only a couple of hours, but the headache lasted several days. On 5/23/2022, I consulted online with a PA-C, and she prescribed a flu test, a COVID-19 test, and a strep test. The only test that came back positive was the COVID-19 test. I was prescribed ipratropium, Molnupiravir, and a cough medication whose name I forget. Shortly after speaking with her, it became more difficult to breathe. It felt like I was having a prolonged asthma attack; this lasted about a day and a half. I work remotely, but I ended up taking time off from work for 4 days, because the fatigue was so intense that I couldn't function. I returned to work on 5/31/2022. I managed to make it through the day, though I was still fatigued. At one point during the day, I had to take a nap, which is not something I normally do. It took probably 3-4 weeks to regain my normal energy level.
Almost immediately upon injection the patient asked if it was supposed to burn and radiate down her arm.  She said her arm was feeling "hot."  Then she said she felt "dizzy and light-headed."  She said she was having trouble focusing her eyes (vision changes).  I had her sit down and she started to sway in a circle.  I called her husband into the vaccination room at that point.  She started to flush and said she felt hot.  She said she wasn't feeling normal.  I asked if she wanted me to call 911.  She said yes.  We called 911.  Then she started to slump over and faint.  I administered Epipen 0.3mg IM in her left thigh at 4:30pm.  She started to have trouble swallowing until 4:32pm.  The police arrived and started to talk to the patient.  The patient started to respond to the Epipen injection, and soon wasn't having any trouble breathing.  She experienced tremors, shakiness, and teeth-chattering until EMS arrived at 4:38pm.  She indicated she wanted to go to the hospital for observation.  EMS administered IM Diphenhydramine on the scene, and she left with them at 4:52pm.
Shoulder, Trapezius pain..severe.  Severe headache.  All occurring days afterwards
diarrhea; joint pain; normally 182 pounds, but he has lost weight during these episodes; chills; a headache kind of pain; This is a spontaneous report from a contactable consumer or other non hcp.  A 65-years-old male patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection), dose 2 via an unspecified route of administration on 17Mar2021 (Batch/Lot number was not reported) as 2nd dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that, Caller clarifies he has had continuous diarrhea problems. He states he had the two shots. About two weeks after the first shot, he experienced the diarrhea problem but he thought the problem would go away. Then he had the second shot and this problem has persisted for about 3 weeks. Caller clarified he had diarrhea after the first vaccine and the diarrhea continued after the second vaccine. He was reading that roughly 10 percent of patients may have similar issues. Right now, he is calling to see if there might be any clues to help relieve his symptoms. He has done blood work and stool samples and those results are coming back fine. He is also taking Imodium, and is toughing it out. NDC, Lot and expiry date not provided.So, he thought with 10 percent of the population maybe having similar problems and he is just trying to learn a little bit more if they were things that happened shortly after the shot and then diminished. He states he is looking for any clues, or any additional data if this is a common side effect, and what the reporting might be. The outcome of the events diarrhoea was not recovered. The outcome of the other events are unknown. Therapeutic measures were taken as a result of diarrhoea (diarrhoea).  Follow up #2 and 3 (06Apr2021): This is follow up a spontaneous report from a contactable consumer. This 65-year-old male consumer (patient) reported information included. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Pain in arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm). At the time of the report, PAIN IN EXTREMITY (Pain in arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-083467, US-MODERNATX, INC.-MOD-2021-083552 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 20-May-2021: Outcome of the event was updated; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083467:Sister's case US-MODERNATX, INC.-MOD-2021-083552:Husband's case
Vaccine given IM in left deltoid on 9/20/16. On 9/21/16 developed swelling in left axilla and baseball sized redness to injection site. On morning of 9/23/16, swelling developed in base of neck on left side. 50 cent sized lump in left axilla. No c/o pain. Previous reaction of swelling after flu vaccine in 2014.
This spontaneous report was received from a pharmacist via a company representative concerning an unknown number of patients of unspecified gender and age. On an unknown date, an unknown number of "adult asplenic patients were vaccinated with a "pediatric dose" of PEDVAXHIB (dosis, lot # not reported). No adverse effect reported. Additional information has been requested.
itchy bumps; rash on thighs, calves and buttocks.; This is a spontaneous report from a contactable consumer (patient). A 22-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8733) via an unspecified route of administration in the left arm on 05Apr2021 at 13:30 (at the age of 22-year-old) as dose 1, single for COVID-19 immunisation. Medical history included known allergy to sulfa drugs. Concomitant medications included ethinylestradiol, norgestimate (TRI FEMYNOR). The patient previously took cefaclor (CECLOR) and amoxicillin (MANUFACTURER UNKNOWN) and experienced drug 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 vaccination. On 10Apr2021 the patient experienced itchy bumps/ rash on thighs, calves and buttocks, the rash occurred after the second vaccine, started two days sooner. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events and included treatment that reported as yes, with recurrence after second dose. Since the vaccination, the patient had been tested for COVID-19. On 18Apr2021, the patient underwent other test and the result was negative. The clinical outcome of the event itchy bumps/ rash on thighs, calves and buttocks was recovering.   No follow-up attempts are needed. No further information is expected.
Within minutes of vaccine, had syncopal episode for approx. 30 seconds. When she regained consciousness, c/o nausea and had emesis. Vital Signs WNL
Swelling of face and eyes, watery eyes, itchy throat with tingling and numbness in lips and nose, itchy hands and ears. Was given PO Benadryl at medical clinic and sent to ED for further evaluation.
Shingles disease symptoms started on 5/6/19 as a itchy rash with out significant pain on patient's back. Presented to outpatient clinic on 5/9/19 and was given 7 day course of Acyclovir 800mg 5x daily.  As of today (5/27/19) rash is resolving and is no longer itching.
This spontaneous report was received from a physician regarding 4 month old infant of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies, and concomitant therapies were not provided. On 18-JAN-2021, the patient was inadvertently vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter (route of administration, anatomical location, vaccine scheme, lot number and expiration date were not provided) as prophylaxis; instead of the pneumococcal 13v conj vaccine (CRM197) (PREVNAR 13) vaccine. It was not noticed until 19-JAN-2021 (wrong product administered) (product name confusion). One of the billers in the physician's office noticed the mistake when she was recording the administered vaccine in the patient's medical record. The physician stated the he did not keep much Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23)  in his office since it was rarely administered there. He knew that he had three doses of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) and went to check after this report, and now had only two doses left.
Rectal Bleeding.  Diagnosed as an Ischemic Colitis event.  3 days on liquid then soft diet.
A few hours after the shot I had fever and chills that lasted 36 hours. I noticed a rash around the site about two weeks after. There were bumps as well. My blood pressure increased out of nowhere about a week after. My usual medication doesn't seem to have helped.
At 8 hours post vaccination the following symptoms occurred: muscle pain and weakness, 104 fever, pain at injection site, shortness of breath, dizziness, vomiting, diarrhea, tacchycardia, fatigue headache, and profuse sweating.  These symptoms continued for 4 days.  Three days after vaccination pain in left calf started.  Still continues to present day.  Hot flashes started with fever have continued, and continue to present day.  Hot flashes and night sweats cause to wake  at night.  Hot flashes continue 12 or more times each day.
Loss of Appetite; Fatigue; Swelling near the injection site; Fever; Sore arm; Swollen Arm; This spontaneous case was reported by a non-health professional and describes the occurrence of PYREXIA (Fever), PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (Loss of Appetite), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Swelling near the injection site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. unknown and unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PERIPHERAL SWELLING (Swollen Arm). On 19-Feb-2021, the patient experienced PYREXIA (Fever), DECREASED APPETITE (Loss of Appetite), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Swelling near the injection site). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 25-Jan-2021, PAIN IN EXTREMITY (Sore arm) and PERIPHERAL SWELLING (Swollen Arm) had resolved. At the time of the report, PYREXIA (Fever), DECREASED APPETITE (Loss of Appetite), FATIGUE (Fatigue) and VACCINATION SITE SWELLING (Swelling near the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       This case was linked to MOD-2021-020503 (E2B Linked Report).; Sender's Comments:  MOD-2021-020503:Same patient, 1st dose
Red, warm to touch, raised area started 5.22.15 at 8 pm. Went to urgent care-prescribed AUGMENTIN antibiotic, pt. took for 2 days it went away per mom.
Starting the day of the vaccine (at night) I started developing malaise, fatigue, headache, and fever. This went on for about 3-4 days. Ever since then, I have been fatigued and feeling "not myself". I have been having intermittent headaches and dizziness that have not resolved. I went to the ER on 01/14/2022 for a headache and chest pressure. My blood pressure kept going up but after numerous tests/blood work everything came back normal. However, I am still plagued by the intermittent headaches. I saw my PCP afterwards and they said I should start Elavil for the headaches but I haven't had a chance to pick it up yet.
Within 5 hours, patient was awakened from her nap but found that her eyes were swollen shut, upper lip was swollen and her gums itched.  Her head was hurting which is what awakened her.  She went and looked in the mirror, she immediately took a Benadryl 25 mg oral gel cap.  Within 20 minutes, the swelling and itching started to improve.  The symptoms resolved after taking the Benadryl.  The next day, she went to work.  She took another Benadryl at 10 AM on Friday, slept all day.  She ran errands on Saturday, took a Benadryl with her just in case.  She also carried an Epi pen.  Her feet began to swell, her hands swelled and she started itching all over.  Her throat began to close.  She took a Benadryl immediately (this is day 3).  The symptoms did resolve.   She returned home.  On day four, she had some nausea.  On day five (Monday), she went to work and her tonsils started throbbing.  She ran her bus driver route.  She was itching all over again.  She took another Benadryl . She called Dr. on day 5 after vaccination because of the recurring symptoms.  She also called her allergist.  She had an appointment with her allergist on day 6.  Family Doctor also called back on Day 5 and called a prescription in for Prednisone.  She did not start the Prednisone.  She did see the allergist on day 6. The allergist thinks her reaction might have been due to the preservative in the Moderna product.  It was the only ingredient in both the flu shot (7 years ago) and the Moderna contents.  She advised her to take the Prednisone dose pack (as prescribed by family doctor) to over-ride and she upped her Zyrtec to bid.
Redness heat, swelling at site. Extreme muscle pain persists. Painful to abduct greater than 75 degrees. Improving.
At approximately 12:30pm I developed tachycardia "felt like my heart was going to pound out of my chest", I also developed hives, reddness, and swelling on my face.  I felt like my face was sunburned, I was shaky, anxious, and I have numbness in my fingers.  I work in a surgical center, the nurse took me to the recovery room and alerted help.  After resting for 20 minutes I felt symptoms resolving- received po Benadryl 25mg, however, within approx 10 minutes symptoms returned: dizzy, elevated temp. 38.0, difficulty swallowing, dry mouth, shaking, numbness in hands, hives on face and neck, anxiety and difficulty making a decision, and nausea.  Treatment- IV epinephrine, IV Solu-Medrol, IV Benadryl 50mg, IV Zantac.  Transferred by ambulance to the ER.  Received IV Zofran and discharged after approx. 4 hours.
This spontaneous report as received from a pharmacist via field employee refers to unspecified patients of unknown age. On an unknown date the unspecified patients was vaccinated with ZOSTAVAX (lot# not reported) (start date, dose, route not reported). It was reported that unspecified patient developed shingles after receiving ZOSTAVAX. The outcome was unknown. Additional information has been requested.
Systemic: Anaphylaxis-Severe, Systemic: Rash (other than injection site)-Severe
Severe abdominal pain, nausea, dizziness, headache, fatigue, fever
Developed chest pain, vomiting, and dizziness after vaccines were administered, 5 minutes after vaccines. Observed for 10 additional minutes. Normal Exam. Walked out of office on his own.
Infant ran temp of 102 deg F. for 1 day then temp down to 99 deg. F. Mother reports pink raised bumps around IPV injection site. Mother gave Motrin.
Chills; mild headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "Chills"; HEADACHE (non-serious), outcome "unknown", described as "mild headache".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.