chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for Covid; tested positive for Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 55-year-old male patient received BNT162b2 (COMIRNATY), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and 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 "tested positive for Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive for Covid. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
7 year old was administered Kinrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old female patient who received DTPa-IPV (Kinrix) (batch number G9N2M, expiry date 14th April 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th November 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 17th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 9-Dec-2022 Reporter's comment: The reporter knew that this was outside the recommended age range. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Kinrix in error at inappropriate age, which led to inappropriate age at vaccine administration.
Rash on upper legs and chest following fever, headache, body aches, and chiils.
No additional AE reported.; VARIVAX that had undergone temperature excursion was administered to a patient; This spontaneous report was received from registered nurse and refers to a 7-year-old patient of unknown gender.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 06-SEP-2022, the patient was vaccinated with varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, quantity: 1, lot #W002601, expiration date: 24-JAN-2024, administered for prophylaxis (strength, and route of administration were not provided)(product storage error). The vaccine was exposed to the temperature excursions for 1 hour and 45 minutes. There was no previous temperature excursion. No additional adverse event reported.
Patient received DTaP vaccination right upper thigh on 08/16/2003.  Developed cellulitis right thigh over area of administration.
A nurse reported that a female patient in an assistant living facility inadvertently received an intradermal injection of Pnu-Imune 23 instead of PPD and subsequently developed an injection of site reaction characterized by redness, swelling,and inflammation. The reporter declined to provide additional information and declined to grant permission for FOLLOW-UP.
None COVID -19 EXPIRED 10/25/2022 GIVEN 01/06/2023
Cough, tachycardia, flushing.  Initially improved without treatment, took antihistamine at home, but cough and a feeling of pressure in face worsened.  Cough persisted and she was unable to sleep that night.  Took Benadryl, Pepcid and pushed fluids.  No further airway prolbems, but did not work the next day.  Was back at work and back to normal on Jan 15.
Pt reported this information to vaccine providers when he presented for his COVID booster vaccine on 12/7/2021: Pt reported visiting emergency department the day following his 2nd COVID vaccine dose with severe headache and dry heaves. Received IV hydration and discharged home, NO hospital admission. No residual issues reported since that time. Following his first dose on 3/30/2021, pt also presented to the emergency department with sx of fever, nausea, vomiting, hypertension and some chest pain. He was kept for observation in the ER but released the next day. Pt was positive for COVID in Dec 2020 and received monoclonal antibody therapy on Dec 27.
This spontaneous report as received from a licensed practical nurse refers to a 1 year old patient. The patient was vaccinated with a 0.5 ml dose, SC VARIVAX (merck) (Lot #669846/0344AA) on 08-DEC-2011. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced chicken pox. No treatment information was reported. The outcome of chicken pox was unknown. The relatedness for chicken pox was unknown for VARIVAX (Merck). This is one of several reports from the same source. Additional information has been requested.
Intermittent chest pain and right trunk/axillary pain. Was seen by primary doctor and presents to the ER  for chest pain to r/o cardiomyopathy. EKG, labs, cxr ordered
Patient called about 4 hours after receiving the vaccine and reported, arm pain, redness, warmth at the site, and stated she could not move her arm. She used tylenol and ice, the next morning, she called and said she had pain in her shoulder and along with the pain in her arm being worse.
Patient reported allergic reactions to shellfish, beta blockers, Zantac and terbutaline.  From Dr. Physician's Notes 9/13/2021  Patient had received 1st Covid 19 Pfizer-BioNTech shot at about 10:10 this am on 9/13/21.  At about 10:18 complained of lower lip swelling and itching on back and legs..  10:19 Benadryl 50 mg IM Given with no improvement but no worsening of symptoms.  10:35 BP 145/97 P 80 r 16, Lungs clear, no urticaria, lower lip and upper lip swollen. No mouth or throat swelling, no shortness of breath. No urticaria. Epi 0.3 on standby. Rec EMS to be called.  10:45 BP 148/102 P 72 R 16 no change in complaints still itching and still lip swelling. No worse but no better. No mouth/throat swelling, no shortness of breath, No urticaria. Epi 0.3 on stand by  10:49 Benadryl 50 mg IM given  10:55 BP 160/100 no change in complaints still itching on back and legs and still lip swelling. No worse but no better. No mouth/throat swelling. No shortness of breath. No urticaria. Epi 0.3 on stand by.  1110 EMS arrived patient status quo. O2 99, Pulse 76, lungs clear. no urticaria, no mouth or throat swelling. Continues to have lip swelling and itching back and extremities. Left in stable condition with EMS.  I do not recommend a 2nd shot in this setting. She should speak with her primary care doctor regarding recommendations and types of any future Covid vaccines.
Urticarial rash 4 hrs after vaccines administration; required Benadryl for treatment in ER.
Immediately after administration of HPV vaccine pt fainted for few seconds about 6-8 sec (fainting).
Patient received flu shot (Hi dose) on 9-12-14 at about 9:23AM. She started having high fever (about 101.4 degrees F), shivering (shaking), numbness in fingers, chilling all at about 5:30 PM after she came back from work. Feeling better the next day.
Flu like symptoms; BODY ACHES; Confusion; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (BODY ACHES), CONFUSIONAL STATE (Confusion) and FATIGUE (Fatigue) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Crohn's disease and Rheumatoid arthritis.    Concurrent medical conditions included Crohn's disease and Rheumatoid arthritis.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. In November 2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (BODY ACHES), CONFUSIONAL STATE (Confusion) and FATIGUE (Fatigue). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (BODY ACHES), CONFUSIONAL STATE (Confusion) and FATIGUE (Fatigue) was resolving.            No concomitant medications were reported. No treatment medications were reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
Positive covid test on May 3rd: Sore throat, extreme fatigue, dry cough, congestion, migraines Was prescribed a 5 day prescription of Molnupiravir Currently still experiencing some fatigue, dry cough, and congestion
pt recv vax & had sx of n/v, flu like sx, inc temp to 101 w/onset 2 days p/vax;had real bad cough, sore throat, been sick since vax;
Pt. developed severe red rash on face, neck, and chest within five minutes of vaccination noted by two volunteer doctors on site at clinic. Pt. also c/o anxiety. Doctors on site administered Benadryl 25 mg po @1105. 1110: BP 153/98, Pulse 109, O2 sat 98%. Moved pt. to cot and continued to assess. No hives, itching, or swelling noted. 1120: BP 143/86, P 97. Pt.'s rash, flushing, and anxiety improved.  1130: BP 139/81, P 81. Pt. continued to improved and deny lightheadedness or SOB, left vaccination site @1150.
Very sensitive skin starting at about 9:00 am until late in the evening. Clothing was annoying to have touching my legs especially.
patient experienced fatigue after vaccine and  non itchy rash over entire body for 1 month. Still has rash on thighs after 1 month
Redness, soreness, swelling, bruising at injection site, significant from day one to about day ten, minor from about day ten through day 21; general body aches days two to three.
Patient received Pfizer Covid-19 vaccine #dose -1 at the pharmacy on 09/22/2021. After he left immunization room,  he passed out for about 10 seconds, falling on the floor on his face. According to the people around him, he recovered in short time (approximately 10 seconds), and he was fine. Pharmacy asked him if he needed 911  three times but he denied. He called his mom for drive home. Mom stated that ever since he was young, he was so scared of needles. They left pharmacy without any problem.
Numbness; Tingling in leg and face; Tingling in leg and face; Extreme pain in the arm where she had vaccination; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness), the first episode of PARAESTHESIA (Tingling in leg and face), the second episode of PARAESTHESIA (Tingling in leg and face) and VACCINATION SITE PAIN (Extreme pain in the arm where she had vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness), the first episode of PARAESTHESIA (Tingling in leg and face), the second episode of PARAESTHESIA (Tingling in leg and face) and VACCINATION SITE PAIN (Extreme pain in the arm where she had vaccination). At the time of the report, HYPOAESTHESIA (Numbness) outcome was unknown and VACCINATION SITE PAIN (Extreme pain in the arm where she had vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD-2021-093549 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: AE outcome
The Pentacel vaccine that was administered was only partially administered; the HIB portion of it was not mixed with the DTAP-IPV portion of it. Sanofi-Pasteur was called; Sanofi-Pasteur advised giving an ActHib vaccine additionally. They advised that the DTAP-IPV portion of vaccine is valid and counts as a valid DTAP and IPV vaccine.
numbness from the neck down.  unable to walk. loss of hand movement. progressively got worse each day until hospitalized.  pain throughout body.
Severe chest, shoulder and neck pain with tension headaches; worsening with twisting or bending of the torso; shortness of breath; rapid heart rate with mild exertion.
On March 27, 2021 at about 2:30 a.m. I was awakened from sleeping by strong nausea. It felt like wave after wave of nausea in rapid succession. Then about 4:00 a.m. it suddenly stopped.
bad headache; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:. The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Covid-19 vaccine (Primary immunization series completed, unknown manufacturer), for Covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "bad headache"; FATIGUE (non-serious), outcome "unknown".  Additional information: Caller would like to get recommendations about the side effects of the vaccine, because she had really bad headache and fatigue before during the trials, she was working for the (Department name), she just got her booster shot and asking for some tips, she also took Aspirin.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Vomiting; Diarrhea; Head ache; Dizziness; Chills; Scared to eat in fear of vomiting; Arm hurts a lot; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting), DIARRHOEA (Diarrhea), HEADACHE (Head ache), DIZZINESS (Dizziness) and CHILLS (Chills) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting), DIARRHOEA (Diarrhea), HEADACHE (Head ache), DIZZINESS (Dizziness), CHILLS (Chills), FEAR OF EATING (Scared to eat in fear of vomiting) and PAIN IN EXTREMITY (Arm hurts a lot). At the time of the report, VOMITING (Vomiting), DIARRHOEA (Diarrhea), HEADACHE (Head ache), DIZZINESS (Dizziness), CHILLS (Chills), FEAR OF EATING (Scared to eat in fear of vomiting) and PAIN IN EXTREMITY (Arm hurts a lot) 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.
Vaccine was not received. I am vaccinating pharmacist and also immunosuppressed (REMICADE, IMURAN, Prednisone). Developed shingles within 6 weeks of starting to handle the ZOSTAVAX vaccine.
PATIENT CALLED STATING HIS ARM HAS BEEN HURTING SINCE RECEIVING THE VACCINATION ON OCT 7. HE WAS INSTRUCTED TO BE SEEN BY A HEALTH CARE PROFESSIONAL WHO COULD ASSESS HIS CONDITION AND REPORT BACK TO US ASAP.
Developed bumps on face that spread on the face, but did not itch about 2 days after vaccination. Within a week, it spread to the neck. The bumps on the face are now gone, but the neck is still dry, red, & itchy.
Dizzy, weakness, anxiety, tingling and numbness  in hands and feet, nauseous, and throwing up, mensural cycle changes/hormone changes (bleed longer and heavier) headaches
Received Tdap, polio, and PPD 1/7/08. C/O chills, freezing sensation, mild nausea, headache and site tenderness left arm last night. Unable to stay warm with multiple blankets. Did not take temperature or take any medications for. Denied sweating, vomiting, diarrhea, muscle aches, chest pain, breathing difficulty, visual problems, lymph node swelling, or any edema. Denied recent illness, travel or new exposures other than recent vaccinations. Denied receipt of VIS forms. Feeling as well as can be expected Is okay and functions, but very tired due to poor nights sleep.  Working with children at day care center, feeling tired (fatigue), feeling poorly (malaise), and recurrent chills chills come and go.  No night sweats. Headache dull pounding sensation all over head especially when feels a chill. 2/10 scale, no visual disturbance, tinnitius, n/v, dizziness.  No hx migraines. Gets headaches with storms or sudden change in weather.  No sinus pain. No neck symptoms.  No eye symptoms.  No otolaryngeal symptoms.  No cardiovascular symptoms.  No pulmonary symptoms.  No gastrointestinal symptoms Had nausea last night but okay today.  No endocrine symptoms.  No musculoskeletal symptoms.  No neurological symptoms.  No psychological symptoms.  No skin symptoms.
Soreness in left arm around point of delivery; flu or cold like symptoms such as body ache fatigue sinus congestion and pain.
2nd time reacting to Immunizations, left leg swollen, red and child is very fussy.
Information has been received from a licensed practical nurse concerning a female who was inadvertently vaccinated SC with a 0.5 mL dose of measles virus vaccine live (enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (Lot# 655487/0749U) because the vial was placed in the box for varicella virus live (MSD). Suspect vaccination administered on the same visit included a dose of measles virus vaccine live (Enders-Edmonston) (+) mumps virus vaccine live (Jeryl Lynn) (+) rubella virus vaccine live (Wistar RA 27/3) (+) varicella virus vaccine live (Oka/Merck) upgrade process) (lot #657534/0474U) into a different site. The nurse stated that this error was human error and not a case of product confusion. After follow-up with the patient, no adverse symptoms were noted. There was no product quality complaint. Additional information has been requested.
22OCT98 immed devel hematoma p/vax;23OCt98 ecchymotic area the size of tennis ball;edema subsided;
Realized after the fact that the vaccine had been given using 5/8 subcutaneous syringe in the deltoid muscle. No adverse events reported
Information has been received from a consumer who read that "someone" on unknown date was vaccinated with ZOSTAVAX (Merck) (Lot number not reported) and developed skin cancer (date not specified). The outcome for the patient was unknown. It was unknown if the patient sought medical attention. Upon internal review, skin cancer was considered to be an other important medical event. This is one of two reports from the same source. Attempts are being made to verify the existence of a patient. Additional information has been requested.
Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and NAUSEA (Nausea) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment information was not reported.
idiopathic thrombocytopenic purpura; rash and swelling on her arm; rash and swelling on her arm; This spontaneous report was received from a lawyer, regarding a case in litigation and refers to a female patient (pt) of an unknown age. The pt's medical history, concurrent conditions and concomitant medications were not reported.  On or around 17-JUN-2017, pt was vaccinated with zoster vaccine live (ZOSTAVAX) (exact dose, frequency, site and route of administration, lot# and expiration date were not reported) for routine health maintenance and the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), pt suffered from rash and swelling on her arm. She also suffered critically low platelet count shortly after receiving the vaccine and was diagnosed with idiopathic thrombocytopenic purpura that required various lengthy hospitalizations and continued treatment. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), pt's symptoms resulted in physical limitations not present prior to the vaccination. Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), she had suffered and incurred damages, including medical expenses, the loss of accumulations and other economic and non-economic damages  The relatedness between the events and zoster vaccine live (ZOSTAVAX) was reported as related.  The reporter considered the events to be disabling.  Upon internal review, the event of idiopathic thrombocytopenic purpura was considered to be medically significant.
5/4/09 ZOSTAVAX administered; pain at injection site 5/5/09 redness/hardness 3 inches wide & 6 inches long extending from injection site & down the arm. Also bumpy in a line from the injection site. 5/6/09 1 AM shaking & chills (did not take temperature) 5/6/09 330 AM shaking & chills gone 5/7/09 Decreased redness 5//09 prescribed CEPHALEXIN. Still monitoring.
I started to feel dizzy throughout the day the day after the shot. I saw that some serious side effects was dizziness but it was the day after which is why I?m not super worried but I am concerned. I?ve tired to lay drink whatever and lay down but once getting up I feel dizzy.
This spontaneous report as received from a pharmacist refers to a currently 77 years old male patient, who was also a physician. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # not reported) for prevention of shingles. At an unspecified time, after he had received ZOSTAVAX, the patient developed shingles. The outcome of adverse event was unknown. The relatedness between ZOSTAVAX and adverse event was unknown. Additional information has been requested.
new CVA symptoms, memory, slurred speech, > weakness, < oxygenation, > confussion