chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Client presented to the vaccine site with her mother and received her COVID vaccine Pfizer Booster (lot #FL3198) in the L arm at 1715 and the Fucelvax Influenza vaccine (lot #308496) in the R arm at 1716 by vaccinator. At 1735 the client notifiedEMT that she "feels hot" and EMT immediately notified Lead RN . RN assessed the client while EMT provided the client water and took client's vitals. RN assessed a rash across the client's chest. Client was A&O x4 and denied SOB, dizziness, nausea, and pain. No swelling observed. Client stated that her lower arms felt "itchy". Client stated she had NKDA, no chronic conditions, and did not have a reaction to her first 2 doses of Pfizer or previous Influenza Vaccines. Client stated the last time she received the Influenza vaccine was 2 years ago. At 1735 client's vitals were 180/108, HR 99, SPO2 99%, and RR 18. RN recommended that the client take IM Benadryl to help relieve symptoms. Client agreed to taking Benadryl and EMT assisted client to zero gravity chair. At 1742 RN drew up 50mg of Benadryl and administered to the client in the L arm, 1 inch away from the Flucelvax injection. During administration of IM Benadryl, some of the vaccine was wasted and leaked out of the syringe. RN notified Vaccine Operations Leadswho advised that re-administration of Benadryl is not indicated. At 1752 clients vitals were BP 140/106, HR 85, SPO2 98%, and RR 16. Client reported that the last time she ate was around 12pm. EMT provided client another water and saltine crackers.  RN educated the client on the effects of Benadryl and the client verbalized understanding. At 1757 the client stated that the "heat" sensation was almost gone and stated "the pumping of my heart is much better".  RN observed very mild redness on the chest, and no rash on the chest or arms was observed. Client stated that her itchiness on the arms was "almost better" and stated that she felt very mild itchiness on her back. RN assessed client's back and did not observe any redness or rash. At 1800 client's vitals were BP 136/98, HR 78, SPO2 98% and RR 16. The client continued to drink water and ate crackers. After futher assessment, the client remembered that she has an allergy to sulfa drugs and ampicillin. Client is not taking any medication. At 1609 client stated she "doesn't feel hot anymore". RN advised the client that she should not drive home and her mom who was with her said they will call her uncle to pick them up.  RN advised the client remain in observation for a full 30 minutes after administration of Benadryl. At 1815 client's vitals were 148/106, HR 86 SPO2 100% and RR 16. Client stated the itchiness on her arms and upper back was returning but it was "bearable". RN recommended calling EMS due to return of symptoms but client denied. At 1620 client stated the heat was returning and she felt like there was a "heaviness" in her throat. RN notified client that due to symptoms, protocol requires activation of EMS. RN activated EMS at 1620. At 1621 the client was A&O x4, client's SPO2 was 100%, and no swelling of the face, neck, or throat was observed. RN assessed erythema on the chest and upper back. At 1625 EMS assumed care of client.
2nd vaccine dose administered 21 days after the 1st dose.  Moderna requires a 28 day interval. Second dose was given 7 days early on this date.
Diarrhea; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 26-Mar-2021 and was forwarded to Moderna on 26-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) and DIARRHOEA (Diarrhea) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced FATIGUE (Fatigue). On 19-Mar-2021, the patient experienced DIARRHOEA (Diarrhea). At the time of the report, FATIGUE (Fatigue) and DIARRHOEA (Diarrhea) outcome was unknown.            No treatment medication was taken. No concomitant medication was taken.
he received 2 initial Pfizer-BioNTech Covid vaccines and then the booster in Dec2021. He got covid in April; he received 2 initial Pfizer-BioNTech Covid vaccines and then the booster in Dec2021. He got covid in April; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), in Dec2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he received 2 initial Pfizer-BioNTech Covid vaccines and then the booster in Dec2021. He got covid in April". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Apr2022) Unknown results, notes: He got covid in April. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The caller stated he has already been on the phone for 24 minutes. He thought it would be quick but he called and got transferred to me from someone else. Request Name. Product: PAXLOVID. Question: The caller wanted to know how soon after taking Paxlovid can you get a covid vaccine booster. He stated he received 2 initial Pfizer-BioNTech Covid vaccines and then the booster in Dec2021. He got covid in April and took Paxlovid starting on 16Apr for 5 days. Now he is wondering when he can get his second booster after taking the Paxlovid. The caller did not have time to speak with at this time but consented to be contacted if there were additional questions. He provided his physicians contact information but he stated that he did not receive this from him.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
The patient received an expired covid vaccine at an outpatient clinic, Urgent Care. The vial expired on 7/31/22 per extended shelf-life. The current process is covid vaccines are shipped to main hospital and stored in freezer. The Clinic Manager or designated leader from Urgent Care was picking up covid vaccines weekly or as needed to distribute to Urgent Care clinics. The Clinic Manager would store the vials in the refrigerator at Urgent Care to be ready to use. The nurse would pull vial from refrigerator to administer to patient.
About 3-4 days later I am having Shortness of Breath. Its not severe , I walk about a mile everyday; I experienced chills for 4-5 hours next day afternoon; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (About 3-4 days later I am having Shortness of Breath. Its not severe , I walk about a mile everyday) and CHILLS (I experienced chills for 4-5 hours next day afternoon) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 03-Dec-2020. Concomitant products included WARFARIN, ATORVASTATIN CALCIUM (LIPITOR), LISINOPRIL and LEVOTHYROXINE for an unknown indication.  On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 13-Feb-2021, the patient experienced CHILLS (I experienced chills for 4-5 hours next day afternoon).   On 15-Feb-2021, the patient experienced DYSPNOEA (About 3-4 days later I am having Shortness of Breath. Its not severe , I walk about a mile everyday). At the time of the report, DYSPNOEA (About 3-4 days later I am having Shortness of Breath. Its not severe , I walk about a mile everyday) and CHILLS (I experienced chills for 4-5 hours next day afternoon) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No treatment information was provided.
Patient fainted about 1 minute later after being administered vaccine MENACTRA, HPV, FLUMIST and PPD vaccines. We had him sit for 5 mints and was ok, went home.
Anxiety, shortness of breath, tortured sleep for 18 hours. Visual hallucinations and strobing vision with eyes closed. Auditory hallucinations. Got up for 6 hours, then went back to bed for another 12 hours with the same symptoms. They fades about noon on Oct 7.
Approximately 2 minutes after receiving the vaccine, patient started complaining of not feeling well, feeling faint, nauseous and went to sit down. Gave patient water to drink but patient then completely lost consciousness and started shaking, almost in a seizing type way. Called 911 immediately. He regained consciousness after about 15 seconds and was very disoriented. Mom was with patient and stated he had no medical issues, no BP, blood sugar, brain tumor, stroke hx. I took BP and per automatic cuff BP was 65/35. Paramedics came and began to assess the patient. It was determined his blood sugar was low at 67 and patient had not ate at all during the day. Patient was instructed to follow up with primary care doctor and to eat.
Information has been received from a registered school nurse concerning an 8 year old female patient with a history of shingles (2006) and lesions on chest at time of vaccination, who on 02-JUL-2001 was vaccinated with the first dose of VARIVAX (Oka/Merck) (Lot # 638566/1886K) possibly in the right arm. On 14-OCT-2008, the patient was diagnosed with varicella. On 14-OCT-2008 was performed an exam at pediatrician office (results not provided). The patient sought medical attention by doctor visit. The patient's varicella was currently ongoing. Additional information has been requested.
This case was reported by a consumer via out of hour services and described the occurrence of renal failure in a adult male patient who received SHINGRIX for prophylaxis. Previously administered products included shingles vaccine (received in 2016). Concurrent medical conditions included pinched nerve, tremor (rolling tremor in hands occurred in 1996), diabetes and iodine allergy (deathly allergic to iodine). Concomitant products included gabapentin, Metformin, omeprazole, Baby Aspirin and primidone. On 6th March 2018, the patient received the 1st dose of SHINGRIX. On 6th March 2018, 2 hrs after receiving SHINGRIX, the patient experienced nausea, tiredness, burning sensation and blurred vision. On 15th March 2018, the patient experienced renal failure (serious criteria GSK medically significant) and renal pain. On 23rd March 2018, the patient experienced sleepiness. On an unknown date, the patient experienced unable to walk. On an unknown date, the outcome of the renal failure, renal pain, sleepiness and tiredness were not recovered/not resolved and the outcome of the nausea, burning sensation and blurred vision were recovered/resolved and the outcome of the unable to walk was unknown. The reporter considered the renal failure, renal pain, nausea, sleepiness, tiredness, burning sensation, blurred vision and unable to walk to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The patient received SHINGRIX on the left shoulder and he felt like they used the biggest needle on him. Immediately after vaccination, the patient experienced a burning sensation in his arm and nausea, blurred vision and was tired two hours later. The clinic told him that the base of the serum contains iodine and now he may need kidney dialysis. On 15th March 2018, the patient had some labs done and checked urine (result unknown). On 23rd March 2018, the patient ended up in the emergency room. The patient felt asleep in the lobby and they never took him back to be admitted. The patient claimed that after he left the emergency room, he slept for 24 hours. The patient claimed that he had kidney pain with organ shutdown which was described as flank pain with left kidney. The patient claimed that he was deathly allergic to iodine and he was provided iodine with a stress test many years ago and they had to give him a shot of something to reverse the reaction. The patient was relating that experience to his current experience with SHINGRIX. The patient used to walk a few miles per day and at the time of reporting he could not walk because of the kidney issues and he was extremely tired. The patient claimed that he had a legal case against pharmacy and GSK because the company did not provide a list of ingredients to the pharmacy for the vaccine. The patient had denied permission to contact their physician.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 30-OCT-2009, the patient was inoculated with ZOSTAVAX at a physician's office for routine health maintenance and for the prevention of shingles.  The vaccine did not prevent shingles as intended but rather caused the patient to contract a persistent strain of herpes zoster. On or about 18-MAR-2015, the patient was treated at a physician's office for the onset of a vesicular rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. On or about 04-APR-2015, she sought subsequent treatment at the same physician's office for ongoing and worsening symptoms related to pain, which was diagnosed as post herpetic neuralgia, a condition of chronic pain and verve damage secondary to herpes zoster infections. 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. The patient was caused to suffer severe and permanent injuries, pain, and mental anguish, including diminished enjoyment of life. The outcomes of the events were unknown at the time of reporting. Causality assessment was related. The lawyer considered vaccination failure, weakened immune symptoms, herpes zoster, and post herpetic neuralgia to be disabling. Additional information has been requested.
Patient received vaccine at 2:30pm. Reported hives and itching at 9:45pm followed up at 9am on 9/21/16-Patient is fine today.
After 3 shots on 01/15/2001 joint pain, (knees, ankles,legs, hands, elbows, fingers,and shoulders)sore feet, depression, and fatigue.
Systemic: patient at first said a palpitation then he thought it may be a muscle spasm-Mild.
Nausea; Lightheadedness; Patient felt SOB after vaccine.  No significant medical history, seen by EMS with no intervention needed.  Released to self care.
Fever and aches on the evening of May 17 and nausea and vomit through the 18-21 of May 2021. Video appointment with my doctor on May 19 she then prescribed promethazine 25mg. It helped but it did make me very tired.
On March 8 Could not put any weight on my left leg. Went to orthopedic clinic took an x-ray and blood test. Diagnosis was gout.
Large (3 inch diameter), red, warm-to-the-touch, sore spot at injection site appeared nearly 2 days after injection. Doctor treated with bactrim (antibiotic) and triamcinolone cream.
This spontaneous report as received from a registered practical nurse via a company representative refers to a female patient of an unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-APR-2014 the patient was vaccinated with her first dose of GARDASIL, (route, dosage, lot number, and expiration date not reported). On 05-DEC-2016 was vaccinated with second dose of GARDASIL 9 (route, dosage, lot number, and expiration date not reported). On 27-FEB-2017 she was vaccinated with a third dose of   GARDASIL 9 (route, dosage, lot number, and expiration date not reported). No adverse event was reported. No additional information was provided. Additional information has been requested.
Patient developed significant chest pain 3 days after receiving the booster shot. He was taken to the ER and followed up with a pediatric cardiologist.  He was placed on a protocol of Advil and antacid for a week to rule out GI conditions or anything else such as muscular involvement.  During any times of increased activity such as in PE or Soccer, he has experienced an increased in chest pain and lightheadedness
chills; fatigue; headache; body aches; fever was 99.8 the first time it presented; arm soreness; This case was reported by a consumer via call center representative and described the occurrence of chills in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th July 2020, the patient received the 2nd dose of Shingrix. On 30th July 2020, 1 days after receiving Shingrix, the patient experienced chills, fatigue, headache, general body pain, fever and pain in arm. On an unknown date, the outcome of the chills, fatigue, headache, general body pain and fever were not recovered/not resolved and the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the chills, fatigue, headache, general body pain, fever and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and chills, fatigue, headache, general body pain, fever was 99.8 the first time it presented.  The arm soreness resolved in one day.   All other symptoms were still present and come and go but had not resolved. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020159668:Same reporter
Information has been received from a nurse practitioner concerning a 18 year old female who in August 2007, was vaccinated with her first dose of GARDASIL. In August 2007, the patient experienced adenopathy, fatigue, fever, sore throat and elevated liver function tests (LFTs) with an alanine aminotransferase test of 177, aspartate aminotransferase of 124 and alkaline phosphatase test of 290. the patient was diagnosed with mononucleosis. The patient's mononucleosis persisted and her LFTs were still mildly elevated. Additional information has been requested.
This is a spontaneous report from a contactable nurse via Pfizer sales representative. A patient of unspecified age ethnicity and gender received pneumococcal PREVNAR 13, via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. The patient experienced adverse reaction related to syncope on an unspecified date with outcome of unknown.
Fever, chills, cough, shortness of breath, HA, nasal congestion. Started about 2 days after immunization and lasted about one week.
Breakthrough COVID-19 case with unknown symptom status. Hospitalized 2/11/2021 for unknown duration
Information has been received from a currently 36 year old female medical assistant referring to herself. There was no information about concurrent condition, concomitant medication and medical history. On an unknown date at the unspecified age of over 26 years, the patient was vaccinated with a dose of GARDASIL (dose, frequency, route, lot# and expiration date unknown) for prophylaxis (inappropriate age at vaccine administration). She did not experience an adverse effect. Additional information has been requested.
Information has been received concerning a pt who on 08/09/97 was vaccinated with one dose of varicella vaccine. On 06/14/2000 the pt experienced a mild pox rash on the abdomen, back, and extremities. She took Benadryl for the itch. She did not feel are act sick. The pt recovered on 06/24/00.
Day 1:Left Arm pit became tingly evening of the injection. Sore injection site  Day 2: Lymph node started to swell. Skin tender in armpit. Fatigue. Sore injection site. Day 3: fatigue, more swelling and tenderness in armpit. Woke with headache. Day 4: headache woke me during the night. Left armpit still swollen and tender. Fever, tingly feeling in face, slightly dizzy feeling. Fatigue.
I have been having symptoms for 6 days now. Feeling very parched, especially after eating Feeling as if I were mildly allergic to what I had eaten and having the impression that upper palate was a little swollen, even if it wasn't. Mouth and upper palate always feels funny after eating making me not wanting to eat much Chalky mouth Mucous in the throat and mouth today Chills, muscle soreness, loss of appetite yesterday
HCP calling to report AE for Supported TE for VARIVA.  Unknown Administered Date LOT# X007373  Exp 3/12/2025  Previous: -14°C to -10°C (-13.8 C) for 0 hours 26 minutes  Current: -14°C to -10°C (-13.0 C) for 0 hours 18  minutes Associated AE Case; This spontaneous report was received from a nurse and refers to a 15-year-old patient of unknown gender. No information on patient's medical history, current conditions and concomitant medications was provided.    On an unknown date the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # X007373 and expiration date 12-MAR-2025, for prophylaxis (dose number, route and site of administration were not provided) (product storage error). Previous temperature excursion lasted for 26 minutes in temperature -14°C to -10 degrees Celsius (°C) (-13.8 C). Current temperature excursion lasted for 18 minutes in temperature 14°C to -10°C (-13.0 C) degrees Celsius (°C).
A nurse, who handled Tice BCG from 1996 or 1997 until 1999, both mixing it and administering it to patients reported she "PPD Converted" (positive response to PPD test), approximately 6 months after she had stopped working with Tice BCG.  She always wore a "special mask", and gown and gloves when working with BCG, and had never had any events of "spills" nor any other known potential exposure incidents.  After the positive PPD a chest x-ray one by the "CDC" (Center for Disease Control), was negative/normal; she had no other symptoms of possible TB infection.  A consulted Infectious Disease Specialist prescribed prophylactic INH therapy and pyridoxine/Vit  B-6.  However, due to the adverse effects from the INH she self-discontinued the INH after 1 month.  She has not had any further follow up chest x-rays or PPD tests.  She has remained asymptomatic but thinks Tice BCG caused the conversion.  Prophylactic INH therapy and pyridoxine/Vit B-6 which she self-discontinued after 1 month.
Immediate stomach ache, pt threw up, nausea, tachycardia, leg spasm, hot/cold, dizzy.