chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt like have kidney stones; It was like the food would not go down/the food wouldn't pass; almost turned blue; Like airway was closed up; wanted to throw up; like deathly ill; This is a spontaneous report from a contactable consumer (patient's friend). This consumer reported similar events for two patients. This is the second of two reports. A 46 years old patient of unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunization. Medical history and concomitant medications were not reported.  The reporter experienced "feels like I have kidney stones", "like the food wouldn't go down", "almost turned blue like the food wouldn't pass", "It was like my airway was closed up", "Like I wanted to throw up" and "like deathly ill". It was reported that the patient experienced the same weird side effects as the reporter had experienced after the covid19 vaccine. The outcome of the events was not reported.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021417459 same reporter, drug and events, different patient.
This is a spontaneous report from a contactable Pfizer colleague reported for his/her daughter. A 17-year-old female patient received first dose of TRUMENBA, intramuscular on 24Jun2016 at 0.5ml, single dose. The patient medical history was not reported. There were no concomitant medications. On 24Jun2016 the patient experienced severe headache, severe chills, numbness (for limbs) over hand and foot, could not walk, trembling, blood pressure abnormal and weak. The patient was hospitalized for the events. The outcome for all events was reported as recovering except for weakness reported as not recovered.
4 hours after injection, my ears started buzzing (tinnitus) and it's been constant since.; This is a spontaneous report from a contactable consumer (Patient). A 74-years-old non pregnant female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 11Jan2021 at 13:30 as 1ST DOSE, SINGLE for covid-19 immunisation. Medical history included atrial fibrillation from 2012 to an unknown date, 1 afib episode in 2012 requiring emergency treatment in hospital 5 hrs, hypersensitivity, rubber sensitivity. Concomitant medications included cyanocobalamin (B-12), Nattokinase (NATTOKINASE); omega-3 fatty acids (OMEGA-3 FATTY ACIDS), Xantofyl (LUTEIN). The patient previously took methylisothiazolinone and experienced drug hypersensitivity. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Jan2021 17:30, The patient experienced 4 hours after injection, my ears started buzzing and it's been constant since. No treatment was received for the adverse event. The outcome of the events was not resolved.  Information about lot/Batch number has been requested. .
Verified with someone else. Kept to 10-15 mins, no a/r.
Information has been received on 09-JUL-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. In 2015, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) unknown route at a pharmacy, as recommended for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. In 2016, the patient was treated at an urgent care for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX and/or despite receiving the ZOSTAVAX for long-term prevention of shingles, 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.
Tip of tongue was burning, weird metallic taste in mouth, entire tongue numb and tingly , throat closing, hard to swallow. received 50 mg Benadryl po
This incident occurred at a mass vaccination clinic.  After the individual received her 2nd COVID-19 vaccine, she walked over to the monitoring area and sat down.  After a few minutes she became dizzy and disoriented, and then fainted. She woke up face down on the floor surrounded by a RN, EMT, and Paramedic.  Baseline of vitals obtained, registering a low BP.  Patient was monitored until VS were all WNL.  After patient was considered in stable condition, she was asked to walk a lap around the indoor venue to ensure she was well enough to leave.  She did so without issue and stated she felt "back to normal" and was ready to leave.  Patient was released at 15:07.
Pt received vaccines and next day developed a "red bumpy, itchy rash" on trunk, groin and upper legs. Mother was advised to contact PCP if sx persist.
sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Prevnar 13 vaccine, administration date: 25Jan2017, for immunisation, reaction(s): "shingles in right eye, on her face and head"; Flu vaccine, for immunisation, reaction(s): "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
She was dizzy about 1/2 hr. after shot. Then she had very sharp pains in her right side (about 4 times) 45 min. to 1 hr. after the shot.
Sore arm; Diarrhea; Had massive vomiting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea) and VOMITING (Had massive vomiting) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No prior medical history was reported.). Concomitant products included FUROSEMIDE (LASIX [FUROSEMIDE]), VITAMIN B1 NOS, VITAMIN B12 [VITAMIN B12 NOS], VITAMIN C [ASCORBIC ACID], VITAMIN D3, CALCIUM, COLECALCIFEROL (CALCIUM PLUS D3), PREGABALIN (LYRICA), ALLOPURINOL, TIOTROPIUM BROMIDE (SPIRIVA), FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (WIXELA INHUB), FINASTERIDE, APIXABAN (ELIQUIS), AZELASTINE, ATORVASTATIN, OMEPRAZOLE (PRILOSEC [OMEPRAZOLE]), DILTIAZEM, DOCUSATE SODIUM (COLACE), MONTELUKAST, CLINDAMYCIN and GLYCERYL TRINITRATE (NITROSTAT) for an unknown indication.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea) and VOMITING (Had massive vomiting). At the time of the report, PAIN IN EXTREMITY (Sore arm), DIARRHOEA (Diarrhea) and VOMITING (Had massive vomiting) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Information has been reported in a government agency slide in the Vaccine Adverse Reporting System (VAERS):This spontaneous retrospective pregnancy report as received from a registered nurse (RN) in Center for Disease control and Prevention (CDC) concerning a female patient of unknown age who experienced gestational diabetes and chlamydia. On an unknown date, the patient became pregnant. The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient was administered with a dose of PNEUMOVAX23 (lot#, dose and route were unspecified) during pregnancy. On an unknown date the patient experienced gestational diabetes and chlamydia. The outcome of gestational diabetes and chlamydia was unknown. The pregnancy outcome was unknown. This is one of the 18 reports (PNEUMOVAX23 administered during pregnancy) that received from the same source. Additional information has been requested.
This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site was kind of swollen), VACCINATION SITE PAIN (Injection site hurt), VACCINATION SITE ERYTHEMA (Injection site looks red), VACCINATION SITE PAIN (A kind of tenderness) and VACCINATION SITE PRURITUS (injection site itchy) in a 40-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 (No medical history reported). Concomitant products included VITAMINS NOS for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2020, the patient experienced VACCINATION SITE ERYTHEMA (Injection site looks red). On 29-Dec-2020, the patient experienced VACCINATION SITE SWELLING (Injection site was kind of swollen) and VACCINATION SITE PAIN (Injection site hurt). On 04-Jan-2021, the patient experienced VACCINATION SITE PAIN (A kind of tenderness) and VACCINATION SITE PRURITUS (injection site itchy). On 30-Dec-2020, VACCINATION SITE PAIN (Injection site hurt) had resolved. At the time of the report, VACCINATION SITE SWELLING (Injection site was kind of swollen), VACCINATION SITE ERYTHEMA (Injection site looks red) and VACCINATION SITE PRURITUS (injection site itchy) had not resolved and VACCINATION SITE PAIN (A kind of tenderness) 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
I was sent to the ER on 10/22/21 for chest pains. My blood pressure and heart rate were elevated- and still remain elevated for my body. I'm on aspirin therapy and I was checked for heart attack and pericarditis. Both were negative. I had lower leg swelling. I continue to have Covid eye and sharp pains in my ears.
SWELLING AND PAIN IN RIGHT ARM FROM INJECTION SITE TO WRIST, PROGRESSED WITH FEVER, NAUSEA, VOMITING, MUSCLE ACHES, ITCHING.  TREATED WITH BENADRYL AND IBUPROFEN.  SYMPTOMS PERSISTED UNTIL MONDAY, JULY 29, 2019, WHEN PATIENT WAS SEEN BY AN URGENT CARE MD, WHO TOLD HER SYMPTOMS WERE NORMAL.  SOME TENDERNESS REMAINS AT INJECTION SITE.  NO OTHER SYMPTOMS PERSIST.
Patient had Covid Feb 2021, received first Covid vaccine 3/30/2021, and second dose 4/17/2021. Began within days of second shot experiencing extreme fatigue, joint and muscle pain, severe rash/hives with extreme itching on face(with butterfly rash), neck, ears, arms, back as well as swollen cracked bloody fingers with bumps.  These symptoms are reoccurring with spans of no rashes for a few weeks, but continual finger swelling with cracks, blood, and bumps. The walk in clinic prescribed steriods and Hydroxyzin Hcl which helped with the systems but did not solve the problem. She was able to be seen by the Rhemulologist on Aug 3, who drew blood with similar findings and prescribed prednisone with a follow up in Feb. 20. His diagnosis was boarder-line Rhumatoid arthritis. She has received several addition prescriptions of steroids and Hydroxyzine Hcl in order to maintain a productive life style.
Injection site began to itch and there's a red circle about 1-2 in in diameter around it. The area is also a bit discolored, potentially from scratching it.
Weak; Tired; Chills; Low grade fever 101; Aches; Like my nose was stuffy; Arm very painful; like a truck had run over me/was a mess yesterday; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Aches), ASTHENIA (Weak), NASAL CONGESTION (Like my nose was stuffy), PAIN IN EXTREMITY (Arm very painful) and FEELING ABNORMAL (like a truck had run over me/was a mess yesterday) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 24-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced PAIN IN EXTREMITY (Aches), NASAL CONGESTION (Like my nose was stuffy), PAIN IN EXTREMITY (Arm very painful), FEELING ABNORMAL (like a truck had run over me/was a mess yesterday), CHILLS (Chills) and PYREXIA (Low grade fever 101). On 26-Feb-2021, the patient experienced FATIGUE (Tired). On an unknown date, the patient experienced ASTHENIA (Weak). At the time of the report, PAIN IN EXTREMITY (Aches), ASTHENIA (Weak), NASAL CONGESTION (Like my nose was stuffy), PAIN IN EXTREMITY (Arm very painful), FEELING ABNORMAL (like a truck had run over me/was a mess yesterday), FATIGUE (Tired), CHILLS (Chills) and PYREXIA (Low grade fever 101) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication information was not reported. Treatment information as not reported.
Headache, nausea, body ache. Decreased over time gone within 24 hrs.
Severe and persistent headaches day and night not relieved by medication. (Ibuprophen, tylenol) for over 2 weeks. Saw Doctor, CT scan and labs ordered, referral to neurology
Patient reports her hands feeling itchy approximately 5 minutes after the injection. The itching progressed into involving her hands, arms, face, and feet over the next 24 hours. She reports no hives or rash, just an intense itching sensation under her skin. She saw her primary care physician's Physician Assistant today, February 24th, 24 hours after her injection. They prescribed hydroxyzine 25mg, prednisone 20mg, and an Epipen injector. The itching was still present when I spoke with her, but she hadn't started the new prescriptions yet.
positive COVID-19 test with symptoms; positive COVID-19 test with symptoms; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient of unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unknown date, for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date the patient got sick and tested positive after the first vaccine dose. Event outcome was unknown. Information on the lot/batch number has been requested.
A rash like reaction on legs, small pin head size red bumps, no itching or pain.
On 8/6/07 c/o soreness from injection site across top fold breast. 8/7/07 c/o chest pain and to take a deep breath that AM. By evening c/o neck pain, no fever but had chills. 8/8/07 Neck pain gone, pain in lt shoulder went across to rt shoulder and chest pain. 8/9 felt better but a little pain in arm.
Patient stated she was nauseous and dizzy all day the day after receiving the injection. Ok after that.
Expired vaccine administered; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 18-month-old male patient who received DTPa (DTaP vaccine) (batch number 5RM39, expiry date 25th November 2022) for prophylaxis.   On 14th February 2023, the patient received DTaP vaccine. On 14th February 2023, unknown after receiving DTaP vaccine, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 15-FEB-2023 Reporter's Comment: A reporter reported that a patient received an expired dose of DTaP.  The reporter did not have the brand name of the vaccine but did provide lot number. The reporter consented to follow up via email. Additional Supportive Information: The patient received an expired dose of DTaP, which led to expired vaccine used. As brand name was not specified by the reporter, the product was captured as reported in the narrative.
Approximately 48 hours after the flu shot, I started to feel achy and sore, particularly in my back, stomach, and legs. As the day progressed, the aches and soreness worsened and affected my whole body. I tossed and turned all night due to the discomfort and soreness. I checked my temperature in the middle of the night and I had a fever with a temperature of 101. Now I am approximately 72  hours after the vaccine and still feel a little sluggish and achy.
I experienced tingling and burning in left arm along with muscle soreness and stiffness.Also, had head-ache, tingling and cool sensation in brain, irregular heart beat, lightheaded, extreme fatigue for 2-3 days. Also, 4 hours after the shot had slight heaviness and pressure in chest and lungs and I had to sleep elevated. On the second day in the morning had chest pain off and on,fatigue and muscle soreness in left arm. On the third day experienced fatigue, chest pain off and on and pain in the right abdomen/ovary.
ACTHIB was mixed with sterile water instead of ACTHIB diluent and administered to a patient with no adverse event; Initial information regarding an unsolicited valid non-serious case was received from other Health Professional via Medical Information (MI) (Reference number- 00700661) and transmitted to Sanofi on 28-Jul-2021.  This case involves a one-year-old male patient who was administered with HIB (PRP/T) VACCINE [ACT-HIB] which was mixed with sterile water instead of Act-Hib diluent (wrong diluent used).  The patient's medical history, past medical treatments, vaccinations and family history were not provided.  Concomitant medications included VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for prophylactic vaccination.  On 27-Jul-2021, the patient received third dose of 0.5ml suspect HIB (PRP/T) VACCINE (lot UJ399AA and expiry date: 02-Oct-2021) via an intramuscular route in the left thigh for prophylactic vaccination.  The reporter "asking for further guidance."  It was a case of an actual medication error due to wrong diluent used (latency: same day).  At time of reporting no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the 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.
I had a fever and I was stuffed up and coughing. I was sweating at work and by the time I got home, I started coughing and sneezing. That was the first couple of days and it just felt like a cold. I wasn't concerned and unfortunately I didn't think to check a COVID-19 test. One of my associates called and said he tested positive for COVID-19 and we had been in a room together for a while within the last week. I had a lot of coughing and sneezing. I lost a lot of weight in that time. I was around 315-330 lbs at the time and I dropped to 298. The weight loss made me lightheaded, my blood pressure had dropped and I fainted. I fainted and hit my head on the door. I had to get 12 stitches in my head and I was kept overnight at the hospital to make sure I wasn't bleeding because of the ELIQUIS. I still have difficulty breathing and I'm still waiting for my weight to settle before my blood pressure settles as well.
Fever, dihhearea, body aches, extreme tired.  Flu like symptoms arm pain
No additional AE reported; one year old patient administered PROQUAD and VARIVAX on the same day; This spontaneous report was received from an administrator referring to a 1 year old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.    On 03-AUG-2021, the patient was vaccinated with a  dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD), (lot#, expiration date and route were not provided, 0.5 milliliter) and a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot#, expiration date and route were not provided, 0.5 milliliter) for prophylaxis (inappropriate schedule of product administration). No adverse event was reported.
Influenza vaccine given 11/5/02 L deltoid. Became red and swollen in pm-14cm x 10 1/2cm itchy-warm to touch. Looks better todday. No PMD visit made or desired. Taking Benadryl/Tylenol.
pt recvd vax & day following vax pt had gammaglobulin; pt had no rubella virus antibody @ day 1 or day 15 following the vax; when seen in 1990 did have antibodies against rubella virus;
Based on additional information received on 28 January 2016, the case became medically confirmed. Initial unsolicited report received from a consumer on 17 November 2015. This case involves a 44-year-old male patient who was vaccinated with a dose of Flu Vaccine (batch number, route, cycle in series and site of administration was not reported) on 13 October 2014. The patient had allergies to sulfa and "some other antibiotics" and codeine also had history of elevated BP (blood pressure), HIV (Human immunodeficiency virus). Concomitant medications were not reported. On 14 October 2014, one day following the vaccination, the patient experienced dizziness and difficulty in focusing eyes and "panic attack" and it was reported that since vaccination had continued to experience dizziness, eye focus difficulty and developed increased joint pain. The patient also experienced mild case of flu" and malaise. The patient required ER (emergency room)/doctor visit. Lab data included elevated white blood cell counts, red blood cell counts and hematocrit. It was reported that the patient saw his own primary care physician (PCP) for treatment. The patient had not recovered from the events. List of documents held by sender: none. Follow-up information received from a consumer on 21 December 2015. On 13 October 2014 at 10.50 hours, the patient received Flu vaccine (batch number: UI186AA, expiration date: 6 June 2015) in right deltoid. On 25 November 2014 the patient complained of tinnitus, eye pain since influenza vaccine but no change in visual activity and on 18 December 2015 the patient reported severe dizziness when he turns his head. It was reported that, the patient complained of tinnitus but acknowledged chronic problem, prior evaluation with audiometry. On an unspecified date onset of event begun after flu shot and symptoms worse when patient was not busy or pre-occupied. Patient was not seen in clinic since 18 December 2014. On an unspecified date, the patient received Fexofenadine as a corrective treatment. Follow up information received form physician on 28 January 2016. No new information was reported.