chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse event; Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time; Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 056A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). On 02-Aug-2022, POOR QUALITY PRODUCT ADMINISTERED (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time) outcome was unknown. At the time of the report, PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for POOR QUALITY PRODUCT ADMINISTERED (Vial was initially stored in refrigerator on 14-Jul-2022 and was in refrigerator the entire time) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 14-Jul-2022 and was on refrigerator the entire time). Case was created for 6th of 8 adult patient. No concomitant medication was reported by reporter.  Total 2 vials and 8 doses were affected. Vial did not undergo any temperature excursion and were in refrigerator the entire time. 4 patients were administered on 22-Jul-2022 and 4 patients on 2-Aug-2022.  No treatment medication was reported by reporter.
Narrative: COVID infection following COVID vaccine series 02/10, Pfizer, dose #1 03/03, Pfizer, dose #2 08/23 COVID swab, result: detected 08/03 pt cc: chills, cough, dirrhea, fatigue, rhinorrhea, dyspena exposure: unknown
Patient was asked to sit for 15 minutes after. Patient was sitting for about 2 minutes. rph technician, noticed that the patient appeared red, sweating, and about to fall over. Patient went outside and prevented patient from falling over. pharmacy called 911 about the patient, patient was not vomitting, patient was conscious (unconscious maybe about 20 seconds). 911 operator asked for the patient to wait for paramedics to arrive. patient was asked dob and he responded. paramedics took vitals and patient had normal readings. paramedics left afterwards. Then the patient left without any symptoms.
Initial information received on 08-Mar-2019 regarding an unsolicited valid non-serious case received from a non-healthcare professional (Office Staff). This case was linked with 2019SA067108 (same reporter reporting for twins). This case involves a 17 years old female patient who received vaccine MENACTRA in August 2018 (dosing details lot number was not reported) and again received a standard dose (0.5 ml) (lot-U6220AA, 31-May-2020) via intramuscular route in the left deltoid in 07-Mar-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to extra dose administered. It was not reported if patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Information has been received from a registered nurse (R.N.) concerning an approximately 12-month-old female who on 24-SEP-2003 was vaccinated with a dose of MMR and a dose of Varivax. Subsequently, following vaccination the patient developed fever, lethargy and difficulty breathing. Unspecified medical attention was sought. There was no further information on this event. The patient also had another adverse experience following vaccination (WAES# 0609USA00465). Additional information has been requested.
Patient was scheduled for a Well Child Check- 4 months. There was a miscommunication between provider and MA. Patient's parent wanted the flu shot. Patient received the flu shot instead of the parent. Patient, Provider and Medical Director were notified immediately. Patient didn't show any adverse signs towards the vaccine. Patient's parent was educated on signs to look for (fever, allergic reaction, etc.), if any of these signs occurred, patient's parent was told to go to the Emergency Department. Education was given to all MA's about the Administration Rights and also education was given regarding appropriate vaccines for children based on the child's age.
tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): CMOD22-01342 (MODERNA).  A 89-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Aug2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose 1, lot number is unknown, expiration date is not provided, left arm shoulder deltoid muscle as an Intramuscular injection), administration date: 29Dec2020, for COVID-19 immunization, reaction(s): "feeling tired after receiving the first dose"; Moderna covid-19 vaccine (Dose 2, lot number is unknown, expiration date is not known, Intramuscular injection), administration date: 22Jan2021, for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: sars-cov-2 test: positive. Therapeutic measures were taken as a result of covid-19. The clinical course reports as the reporter reports that her husband also had his Moderna primary shot series and a Pfizer booster dose. The reporter husband tested positive for Covid-19 in either Dec2021 or Jan2022. The reporter husband received his first Moderna Covid-19 vaccine on 29Dec2020 lot number is unknown expiration date is not provided. The patient received his first Moderna Covid-19 vaccine in his left arm shoulder deltoid muscle as an Intramuscular injection. The patient reports feeling tired after receiving the first dose of the Moderna Covid-19 vaccine. Reporter does not remember which arm that he received the Moderna Covid-19 vaccine in. Patient received the vaccine as an Intramuscular injection. The patient had no Adverse Reactions or side effects after the second Moderna Covid-19 vaccine. The patient received his booster dose in his left arm shoulder deltoid muscle. The patient reports no Adverse reactions or side effects to the booster dose. The patient tested positive for Covid-19 in Dec2021 or Jan2022. The patient was given two medications at the hospital for Covid-19. Ibuprofen and Acetaminophen.    The lot number for bnt162b2 was not provided and will be requested during follow up.
Sudden onset of facial and oral edema around 2pm after eating pizza and pineapple. Had received influenza injection about 5 hours earlier. Symptoms improved with SQ Epinephrine.
Radiology visit PET IMAGING WITH CT SKULL TO MID-THIGH . This visit was within 6 weeks of receiving the COVID vaccine.
Several minutes after the vaccination was administered she began experiencing numbness and tingling down her right arm to her fingers.
Patient states on Friday, 4/9, he went to the pharmacy to receive his J&J Covid-19 vaccine. He states on Saturday morning, his R nostril began to bleed, and continued to bleed until Monday. He states on Wednesday, 4/7, he noticed oral sores that at first were not painful, but large. He was worried about it interfering with his shot, but because he had waited so long to get it, he decided to proceed anyway. He denies any fever or chills, no frank diarrhea, but occasional loose stools, without blood seen. He denies HA, vision changes, or focal neuro deficits. On Sunday, 4/11, the patient ended up going to ED to evaluate his epistaxis, the MD attributed it to his elevated BP, the patient reports it being 160s/90s. They gave him new BP medications, which he took, but when he saw the Dr., he instructed the patient not to keep taking his BP meds. When asking the patient if anything correlates with foods he eats, the only thing he can pinpoint it to, would be pico de gallo. He states it has irritated his mouth before. He also reports recently taking his wife's supplement (unknown name) but thinks it is for cholesterol. He took that approximately 1 week ago. No new changes in food habits, mouthwash, or toothpaste. He states once his sores began to get a little painful, he went to buy a special mouthwash for oral sores (unsure name). His only reported allergy is to Lisinopril, which his reaction was a whole body rash.    He states they did not pack his nose or do anything for his epistaxis at the ER, but eventually he let the nostril clot with blood. Now he feels fullness in the nare, but does not want to disturb the clot in fear that it will re-bleed. His wife also noticed a petechial rash that began on his BLE, he is unsure when that started.    He presented to  ED on 4/13, due to his PCP  instructing him to be evaluated when he had outpatient labs done and revealed a PLT count of 4,000. In the ED, the patient had normal vital signs.  He was transfused one unit of PLTs. He also had a negative head CT. He was also started on decadron 40mg PO daily by heme/onc. Patient tells me today his sores are less painful and feel smaller than usual. Heme/onc also ordered 2 IVIG 1,000 mg/kg/day x2 doses.
I am HCP, I received my vaccine 01-08-2021. I experienced a sore arm, bit of headache after my vaccine. On 01-10-21, sporadic cough at night. On 01-11-21,  I went to work, felt like I was coming down to the cold. I was tested for positive for Covid on 01-13-2021. I felt like a truck run over me . I ended up on the hospital on 01-17-2021, felt fatigued, felt like I was getting a cold, random cough, kind of a dry cough. I also had a headache felt like a flu, I also felt joint pain. By Thursday 01-14-21 I went to the hospital because I had green mucus, I had an x-ray which showed, lungs were clear and they also checked my ears due to having a flutter in my ears. I initially noticed this on 01-07-21 which happened at night. On Saturday 01-16-21 I had abdominal pain and I suspected it was acute appendicitis. I ended having appendectomy on 01-17-2021. I felt nauseated and threw up and it was like a ?hunger pain?. CT scan lung show pneumonia, grown glass opacities. When I was released from hospital 01-18-21 I still had shortness of breath, and had some had difficulty speaking. My second vaccine was deferred due to having surgery, appendectomy and I had loose stools after the surgery lasting from 01-21-21 to 01-24-21. I did receive my second vaccine till 02-18-2021, lot#006M20A.
Burning rash with appearance of shingles on lower back (same side of body) with flu-like symptoms and low fever (100-101).  Rash worsened over the course of a week.
Fever up to 104. Flu symptoms. Arm (L) swollen. Headache, dizziness, Vomiting and diarrhea. Seen by MD.
Seen on 4/11 for Varicella Vaccine given on 3/29/11. Last week noticed pain at site; local rash at site & also sev. spots on face. Noticed "itchy" areas other places as well. Afebrile. ? dev. chickenpox.
early AM, pea size lump at injection site, itching which grew to a date size lump with reddening and hot to touch by 5PM same day.  lump and redness grew larger over next few days, with itching sensation.  red mark the size of a grapefruit (5").  no pain in arm at injection site, yet swelling/lump and very large red covid burn.
High fever, fast heartbeat, dizziness, light headedness, aches, unable to lift right arm persisting for 2 days.
Had vaccine at Pharmacy yesterday, 01/13/21, felt fine. Next day, 01/14/21, woke up with headache, back pain. Called Doctor office, the doctor said go to Urgent Care if symptoms get worse.
Nausea, initial SBP is 155/87 and heart rate 101.  Repeat BP was 134/84 and heart rate 94.
Information has been received from a physician concerning a female patient who "about one month ago" in approximately September 2010, was vaccinated with a dose of ZOSTAVAX (Merck) (No lot # provided). "A week ago" on 13-OCT-2010 the patient experienced outbreak of shingles after being administered ZOSTAVAX (Merck). Unspecified medical attention had been sought. The status of the patient was unknown. Additional information has been requested.
Woke up with extreme stomach pain and immediately threw up.  Continued to throw up anytime a liquid or food was swallowed for the next 48 hours, with dry heaving in between.  Fever of 103.  Could not administer Tylenol as child would throw up seconds after swallowing.
Cellulitis at inj. site. RX with AUGMENTIN. 2" area of redness noted after vaccine given within 1 hour.
started vomiting, screaming 11 hr p/vax & cont all noc; t102 screamed & fussy 2nd day w/t100;
Delayed onset angioedema.  Swelling of the lips and eyes with itching systemically.
lethargy,dec activity several hrs p/vax;? fever,sz like episode the next day ( dec movement of rt arm & leg);( had rt arm shaking prev to this);eye deviation to lt;
Swelling of his throat; This is a spontaneous report from a contactable consumer or other non hcp (Patient). A 36-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number was not reported, expiry date was unknown), via an unspecified route of administration, administered in the right arm on an unspecified date as dose 1, single for COVID-19 immunization. Patient also received ceftriaxone sodium (ROCEPHIN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient experienced swelling of his throat on an unspecified date. Since unspecified date patient was allergic to Rocephin and it was not ongoing. Outcome of the event was unknown.   Follow-up attempts are completed. No further information is expected
Immediate pain in left arm Felt sinus opening up about 15 minutes in with ?medicine-like? taste in back of throat. 10:30 pm on day of vaccination began tingling sensation in extremities.  Fingers were numb. 11:00 pm on day of vaccination I began to experience severe pain in knees, elbows, fingers, feet.  Whole of body was achy. Began to have heart palpitations and fever shortly thereafter.  Fever ran all night and next day at 101.4 degrees.  Fever did not break until 6:00 pm next day. Feeling of tiredness and sore back muscles next day?like I was hit by a train.
Patient arrived via EMS with reports of shortness of breath. Patient arrived on a CPAP, per patietn report she normally wars 3LPM O2 at home. Patient had COVID booster shot yesterday and had fever, nausea and vomiting. This morning patient was very short of breath and called EMS.HX COPD, per EMS lung sounds are diminished and very wet. SPO2 76% and 96% on the CPAP while on transport. 12 lead was juntional with a bundle per EMS report.
11/26/2013 Severe Other. Pt went to ER with Dx: Intussusception.
Injection site is red, swollen, hot and painful. patient also feels weak and lethargic.
23JUN94 pt came to clinic & reported react occurring 20MAY93 808AM high temp, screaming, shaking-eyes rolled back given APAP 8PM went to ER;
Immediately sore in L arm Tightness/spasm in L neck , spreading to head and hand in few minutes  Lightheaded 10 min Extreme hunger 20 min Chills 40 minutes Exhaustion 80 minutes Spasms and deep ache in L gluts then R glut, L foot, l leg, low back,  Upper back and left hand for 6 days.  Massage and PT adjustment helped minorly.   Tylenol only midly helped with headaches and body aches. Headache for 8 days Still have upper back spasm and arm pain  I am 5'0" and 98#.  My other friends who got this shot with my height/wrifht also got radicular pain doen their arms and legs, numbness etc significantly more than my friends who were larger.  Dosage may be the issue
Presented to the ED c/o of worsening SOB; admitted for COVID-19 pna; tx w/abx, remdesivir, steroids, O2 therapy; weaned to RA and dc'd home
Information has been received from a physician concerning her 8 year old son with no allergies, attention deficit disorder, a history of premature birth (33 week preemie) (also reported as no medical history) who on 7/18/96 was vaccinated SC in the right thigh with a first dose of varicella virus vaccine live (lot # 616997/1656B). There was no illness at the time of vaccination. Concomitant therapy included amphetamine aspartate (+) amphetamine sulfate (+) dextroamphetamine saccharate (+) dextroamphetamine sulfate. On 5/3/04, the patient experienced headache, a sore throat, abdominal pain, and fever 101 degrees F. The following day, on 5/4/04, the patient started with a rash of about 50 lesions. He was treated with diphenhydramine hydrochloride and acetaminophen. A product quality complaint was not involved. Follow up information was received from a registered nurse who indicated that on 5/4/04 the patient developed break through varicella with 30 to 40 spots. He had a fever for two days with a maximum temperature of 101. Subsequently, the patient recovered. No diagnostic laboratory tests were performed. The physician also reported a varicella outbreak in 30 children in the patient's school after therapy with varicella virus vaccine live.
Light-headed/Dizzy; Fatigue; tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable consumer or other non hcp. A 58-year-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0172, Expiry date: unknown), via an unspecified route of administration on 01May2021 as 2nd dose, single dose for covid-19 immunisation. Patient historical vaccine included received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: ER8731), via left upper arm in the muscle on 10Apr2021 as 1st dose, single dose for covid-19 immunisation. Patient medical history included influenza from 2019 to an unknown date went back in 2019, last year in January, they said she had influenza and sent her home and the patient's concomitant medications were not reported. The patient experienced tested positive for covid-19 on 04Jun2021, light-headed on an unspecified date, dizzy on an unspecified date, fatigue on an unspecified date. The patient underwent lab tests and procedures which included sars-cov-2 test it was positive on 04Jun2021 positive for Covid-19. Outcome of the event was unknown.  Follow-up attempts are needed. Further information is requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with an expired dose of lot # (671142/1268AA; exp date 05-NOV-2012) of ZOSTAVAX (dose and route not reported) on 11-NOV-2012. No adverse symptoms were reported. Additional information has been requested.
Fever; Arm pain; This is a spontaneous report from a contactable reporter consumer who is the patient received through a Communication Pfizer Colleague who is patient's friend. This is the second of two reports provided by the same Pfizer employee (Communication Pfizer Colleague).   A 44-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was unspecified) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced fever and arm pain. Outcome of events fever and arm pain was recovered on an unspecified date.  No follow-up attempts are needed. No further information is expected; Sender's Comments: Linked Report(s) : GB-PFIZER INC-2021540134 Different patient, same suspect product, reported trough the same Pfizer employee
The pt developed red, spotted rash, ill after being exposed to varicella at school. Rash began about 3 days prior to office visit.
client complained of nausea, vomit and headache after receiving 2st dose Moderna Covid Vaccine. (Lot# 042B21A, Exp 5/7/21. Client returned from restroom and approached EMTs to inform them she had vomited twice. EMTs guided client to sit down, gave emesis bag and water. Vitals at 1252: blood pressure 124/70, pulse 71, oxygen 99%. PHN  joined EMTs. Client alert and oriented and sitting on chair upon arrival. Per client had been sitting approximately 10 mins prior to feeling nauseous. Per client fist Moderna dose went well, no complaints. Client stated she has been having intermittent nausea, her primary provider is aware and is following up to her appointments. Client stated has not had nausea episode in 2 weeks. Client brought Zofran 4mg oral medication with her today and took one at 1307. Vitals rechecked at 1310: blood pressure 126/72, pulse 76, oxygen 99%. Client reported headache 7/10. Nausea slightly better. Vitals at 1320: blood pressure 130/80, pulse 75, oxygen 98%. Per client nausea had improved, headache still 6/10 pain. Client denied blurry vision, chest pain, shortness of breath. Client wanted to leave, stated she would contact provider today. Client drove herself today, client did not want to call for someone to pick her up. At 1322 client stated she felt okay to drive. Nausea greatly improved, headache the same. ER precautions given. Client left facility with steady gait at 1325.
roughly 24 hours after vaccination patient noticed hard red swollen bicep muscle. She reports experiencing a brief bout of profuse sweating, lightheadedness and increased heart rate that lasted about 15 minutes the day after her vaccine.