chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a pharmacist and physician's assistant concerning a patient who was vaccinated with pneumococcal 23v polysaccharide vaccine (lot 649979/0531P).  Subsequently the patient experienced an injection site reaction with an indurated red area five times the size of the injection site, swelling, inflammation, nausea and fever.  The patient was treated with ibuprofen (MOTRIN).  As OF 04-oct-2005, the patient was recovering from injection site reaction site reaction with an indurated red area five times the size of the injection site, swelling, inflammation, nausea and fever.  No product quality complaint involved.  The pharmacist and physician's assistant also mentioned another patient's experience following vaccination with pneumococcal 23v polysaccharide vaccine. Additional information has been requested.
Throbbing headache throughout the night and continued through the morning. Slight fever throughout the night. Subsided in morning.
Red flush, sweating, hot flash, dizziness, light headed, brain fog all within 30 minutes of injection. All but sweating and red flush resolved with 1 hour. Red flush and sweating continued for 48 hours. Headache and fatigue began about 8 hours after injection and resolved after about 48 hours with the assistance of Tylenol. Left sided muscle pain began about 12 hours after injection and resolved over night after taking Tylenol.
- Acute kidney failure, unspecified  - Hypo-osmolality and hyponatremia
Sudden Cardiac Arrest - after feeling nausea, diarrhea, chills and fatigue.
Shoulder bones, blades very painful. All joints painful, couldn?t even make a fist. Severe chills. Dry mouth, tongue and lips. No matter how much water I drank. Headache and low grade fever (99-101). Heart palpitations. Symptoms started when I woke up the morning after the vaccine and lasted 24 hours mostly but the joint pain still persists almost two weeks after.
pt inadvertently recvd DTAP immun; hep B also administered; w/in 24 hrs post vax pt exp severe soreness in the DTAP arm; also had a low grade fever; No purulent matter present; all sx resolved w/in 4 days;
"Rebound" covid infection; "Rebound" covid infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 01May2021 as dose 2, single (Lot number: EW0171) at the age of 27 years, in left arm for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (COVID-19 VACCINE MODERNA), on 03Nov2021 as dose 3 (booster), single (Lot number: 034F21A), in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation.  The patient's relevant medical history included: "ADHD" (unspecified if ongoing). Concomitant medication(s) included: FEROSUL; VITAMIN D [VITAMIN D NOS]. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as ""Rebound" covid infection". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Unknown results, notes: COVID 19 Treatment; (06Jun2022) Negative, notes: PCR; (12Jun2022) Positive, notes: PCR; (13Jun2022) Positive, notes: rapid; (04Jun2022) Negative, notes: rapid; (05Jun2022) Negative, notes: rapid; (11Jun2022) Positive, notes: rapid. Therapeutic measures were taken as a result of drug ineffective, covid-19. Additional information: No known allergies.  "Rebound" covid infection. After initial infection and during/after her course of Paxlovid from 31May2022 to 05Jun2022 as treatment of COVID-19, she tested negative for covid on 04Jun (rapid), 05Jun (rapid), and 06Jun (PCR). She began feeling sick again approximately 10Jun2022 and tested positive for covid on 11Jun2022 (rapid), 12Jun2022 (PCR), and 13Jun2022 (rapid). Still symptomatic as of 14Jun2022. No treatment received. Patient has not recovered.
arm where vaccine was injected hurt a lot (6-7/10) for 4 days, generally tired, shivering and very cold on first night, aches increased on second day, lower back pain on third day
Right leg weakness  / Muscle wasting away / Fasciculations  No treatment till date  / Mobility affected
Freezing at night/freezing while sleeping; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Freezing at night/freezing while sleeping) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002MJ1A, 051F21A, 030A21A and 013M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING COLD (Freezing at night/freezing while sleeping). On 06-Apr-2022, FEELING COLD (Freezing at night/freezing while sleeping) had resolved.            No concomitant medication information was provided.  Patient experienced events after second booster dose. the after vaccination patient experienced event. Patient felt cold no matter how many blanket patient put on body. Patient stated that had 3 blankets on patient. Next morning on 06-Apr-2022 patient woke up and was no longer freezing.  No treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Apr-2022: Follow-up received contains start and stop date of the e vent, outcome of the event and narrative updated.
Like any tetanus shot, my shoulder was sore shortly after the vaccine was administered.  However, within about 12-24 hours I began to notice the pain intensify beyond that of a typical tetanus shot.  The pain continued to intensify for the next several weeks, leaving me in constant pain and almost completely immobile.  I went to my family care practice one week after the injection to see what was wrong, but the injury was not showing the typical adverse reactions to the tetanus (redness, swelling, etc.), so I was prescribed pain medication for the week and sent home.  To this day, I still have chronic pain and limited mobility in my shoulder.
tiredness; headache; muscle pain; chills; joint pain; fever; diarrhea; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 79-year-old female patient (not pregnant) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administered in arm left, administration date 08Nov2021 13:15 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunization. The patient's relevant medical history was not reported. Concomitant medications included: acetylsalicylic acid (ASPIRIN); levothyroxine sodium (LEVOTHYROXIN); simvastatin (SIMVASTAT); ascorbic acid; ergocalciferol; nicotinamide; retinol; riboflavin; thiamine hydrochloride (VITAMINS). The following information was reported: FATIGUE (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "tiredness"; HEADACHE (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "headache"; MYALGIA (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "muscle pain"; CHILLS (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "chills"; ARTHRALGIA (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "joint pain"; PYREXIA (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "fever"; DIARRHOEA (non-serious) with onset 08Nov2021 20:00, outcome "recovered" (Nov2021), described as "diarrhea". Therapeutic measures were not taken as a result of fatigue, headache, myalgia, chills, arthralgia, pyrexia, diarrhoea.  Additional Information: The patient did not receive any other vaccine within four weeks of the suspect vaccine. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.   The lot number for bnt162b2 was not provided and will be requested during follow up.
allergy; This spontaneous report was received from an anonymized reporter via Pfizer regarding a female patient of unknown age. The patient's relevant medical history, concurrent condition and concomitant medications were not reported. On an unknown date, the patient was vaccinated with Measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (dose, frequency, anatomical location, lot # and expiry date unknown) for prophylaxis. On an unknown date, the patient was allergic to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (allergy to vaccine). The outcome of allergy to vaccine was unknown. The reporter assessed the causality of allergy to vaccine to be related to Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II).; Sender's Comments:  US-PFIZER INC-2019047356:
[Pfizer Covid-19 vaccine] treatment under Emergency Use Authorization(EUA):received the Pzifer COVID vaccine on 12/18/20 at 10:50. I began experiencing numbness and tingling from my knees to my toes 40 minutes following the vaccine in both legs. I am still experiencing tingling and numbness in my legs at times.
Muscle and joint stiffness and aching throughout legs, hips, back, shoulders, neck.  Low-grade fever. Taking Tylenol - Aspirin.
This case was reported by a pharmacist via sales rep and described the occurrence of vaccination failure in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. The patient's past medical history included shingles (previous shingles outbreak). On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and 30 days after receiving SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: There were no concomitant immunosuppressant medicines. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient developed shingles 1 month after getting the 2nd dose of SHINGRIX. The lab results were not confirmed.
Slight rash at injection site. Warm to the touch. Only uncomfortable when touched with slight force.
I received the second vaccine at approximately 10:45am on 4/19/21 at pharmacy; later that afternoon a very bad migraine started do develop, which I did not take medication for as I want to ensure nothing would interfere with the vaccination doing it's job. The pain of said migraine has traveled to different locations in my head between 4/19 through the morning of 4/21 - from the base of the back of the head and neck area to the top/left of the skull and over left eye area. On 4/20/21 at 10:05am, I developed a very unpleasant ringing in both ears that I am very concerned about as it is exacerbating the migraine and is extremely painful.
Hospitalized 01/19/2022; Covid-19 positive 01/19/2022; fully vaccinated  Discharge Provider: MD Primary Care Provider: MD Admission Date: 1/19/2022 Discharge Date: 1/24/22 PRESENTING PROBLEM: Generalized weakness  Failure to thrive in adult  Ear lesion    HOSPITAL COURSE: 1/19: patient is a 79 y.o. female with a history of right single lung transplant for IPF in 2005 as well as hypertension, atrial fibrillation, and CKD3 who is being admitted for generalized weakness and fatigue along with failure to thrive. She was diagnosed with COVID at the end of December, at which time, she was given monoclonal antibody. She was feeling slightly improved after that; however, over the past few days, she has been experiencing worsening generalized weakness and fatigue, particularly with exertion. She is not experiencing any vomiting but has been feeling nauseated. She reportedly saw her PCP today and she was advised to come into the Emergency Department.  Ongoing generalize weakness and fatigue, describes feeling off. No specific symptoms. No pain. No nausea, vomiting, diarrhea, abdominal pain, chest pain, shortness of breath, or urinary symptoms.  1/20: One episode of emesis while working with PT. She remains weak and fatigued.  1/21/22: O2 sats 95% on RA, Awaiting SAR availability 1/22/22: Bradycardia, cardiology consult 1/23/22: AFib. Continue to hold ARB, BB and CCG 1/24/22: Discharge home with in home PT. Resumed Metoprolol at discharge
COVID Pfizer Vaccine Adverse Event  Pfizer Dose 1 8/10/21 (EW0179) Pfizer Dose 2 8/31/21 (EW0177)  9/1/21: The patient presents with fever and Pt is a 24 y/o female with a history of hypertension, hypothyroidism, GERD, hemorrhoids, nephritis, restless leg syndrome, seizure, systemic lupus erythematosus, and anemia. Pt is on dialysis and her nephrologist is Dr. She presents today with a fever, headache, puffiness in her eyes, and general weakness. She states that her eyes were getting puffy for the last couple weeks, which has stayed constant. Her fever began yesterday, which her mother states is the reason that she came in to the ED. Pt got her second covid vaccination yesterday and underwent dialysis yesterday as well. Today, the pt had a fever of 101.8 degrees Fahrenheit today. Pt does not make urine and has had no change in volume. She has no known sick contacts and receives an infusion every month. Pt had lemonade today, but has not eaten or drank anything else. She denies any change in appetite. She sees Dr. for her lupus. She did have covid in April. Pt is on immune suppressants and Prednisone. Pt reports having a similar experience when she had covid and was prescribed Prednisone. Pertinent ROS: She denies cough, shortness of breath, dental pain, ear pain, facial pain, nasal congestion, sore throat, vomiting, eye pain, eye drainage, or diarrhea. She does admit to fever, headache, eye swelling, and generalized weakness..  The onset was 1  days ago.  The course/duration of symptoms is worsening.  Associated symptoms: headache.  Temperature is 101.8  Fahrenheit subjective.  Risk factors consist of dialysis patient and Pt is on immuno-suppressants.  Therapy today: see nurses notes.  9/2/2021:  Pt was admitted to observation with planned dialysis to occur morning 9/2. Nephrology consulted, recs made. Losartan held. All BP meds held while hospitalized. Pt underwent dialysis and her sx resolved. patient was revisited in the early afternoon, objective facial edema had resolved.  Nonlabored respirations, clear speech.  Patient stated that she was at her baseline and requested to see charge home.  COVID PCR negative.  This writer contacted Nephrology and they were agreeable with discharge at this time.   On discharge, losartan will be discontinued altogether. Facial edema cause losartan vs 2nd COVID.  Patient is to resume metoprolol tartrate 50 mg b.i.d. and hydralazine 100 mg b.i.d. as this was her home medication prior to hospitalization. To continue dialysis T, TH, Sat.
Varicella vaccine reaction started 24 hours after receiving Varicella on 8/19/09. Pt reported itching prior to swelling and tenderness. Induration area 5 cm in diameter, no fever- pain or pain radiation, treated with BACTRIM DS 160 mg-800 mg tab. Take one PO Bid x 10 days.
p/vax pt had an elevated temp of 100 w/a h/a, achy muscles, generalized aching throughout the body;pt called nurse & was told to take APAP for the fever;it went away in 12hr;
LYMPHADNITIS IN AXILLA AND SUPRAPCLAVICULAR REGION. NECK MUSCLE SPASM & PAIN / TORTICOLLIS
Soreness in injection arm; Chills; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness in injection arm), CHILLS (Chills) and PYREXIA (Fever) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21H and 021C214) for COVID-19 vaccination.     Concomitant products included VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]), VITAMIN E [VITAMIN E NOS], CALCIUM and VITAMINS NOS (DAILY VITAMINS) for an unknown indication.   On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Soreness in injection arm), CHILLS (Chills) and PYREXIA (Fever). At the time of the report, VACCINATION SITE PAIN (Soreness in injection arm), CHILLS (Chills) and PYREXIA (Fever) had resolved.            Patient was treated with ointment and allergy pills.   This case was linked to MOD-2021-253218 (Patient Link).
Patient developed a vascular rash on hands and elbows, lethargy, aching leg muscles and back muscles as well as edema in her hands bilaterally with hand developing a purple hue. Diagnosed with a rare autoimmune disease Juvenile Dermatomyositis. No cure, hope for a lasting remission, in 1979 3yr survival rate. Seen at hospital, rheumatologist caring for her.
Redness; Pain; This case was reported by a other health professional via other manufacturer and described the occurrence of erythema in a 82-year-old female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Concurrent medical conditions included allergic reaction (to contrast dye), shellfish allergy and iodine allergy. Concomitant products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) and PNEUMONIA VACCINE.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Influenza vaccine Quadrivalent unspecified season, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema and pain were unknown.   It was unknown if the reporter considered the erythema and pain to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient has allergies to shellfish and iodine.  The patient received the pneumonia shot, flu shot, and first dose of the shingles shot. After first dose of shingles shot, she experienced redness and pain. The patient was scheduled to receive the second dose of the shingles shot in January.  The patient works for a big hospital and they would like for her to receive the COVID vaccine. the patient would like to know if it would be okay to receive the COVID vaccine? The patient was unable to have an MRI (Magnetic resonance imaging) due to having an allergic reaction to contrast dye.  The patient states as a kid she had many allergies but has outgrown a lot of them like chocolate.  The patient would like to know if shellfish, iodine or contrast dye were in the covid vaccine? The patient states she would feel better if someone would contact her with more information regarding what ingredients cause people to have an allergic reaction? The reporter consented to follow up.
Started with just sore arm Thursday 02/03/05 AM, then right deltoid became red/swollen at injection site on Friday- 02/04/05. Temperature also Thursday- high of 100.7. Saturday 02/05/05 patient noticed fingers slightly swollen/stiff that increased redness of injection site. Began to resolve that night then by 02/07/05 - "back to normal".
Died of COVID-19 illness on 06/02/2021 Symptoms: low oxygen levels
Noted Hematoma right after injection to left deltoid Pressure applied At 0945 no hematoma noted patient discharged home
Swelling; Extreme pain in left under arm.; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Nov2021 09:00 (Lot number: 32030BD) at the age of 56 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergy: Penicillin" (unspecified if ongoing), notes: Known allergy: Penicillin. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8727, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 04Mar2021, when the patient was 55 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EN6205, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 25Mar2021, when the patient was 55 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021 09:00, outcome "unknown", described as "Booster"; SWELLING (non-serious) with onset 19Nov2021 09:30, outcome "not recovered", described as "Swelling"; PAIN (non-serious) with onset 19Nov2021 09:30, outcome "not recovered", described as "Extreme pain in left under arm.". Therapeutic measures were not taken as a result of swelling, pain. Clinical course: Prior to vaccination, was the patient was not diagnosed with COVID-19. Since the vaccination, has the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received within 2 weeks of vaccination Follow-up attempts are completed. No further information is expected.
I received the vaccine in my right arm at 1:30p on Wednesday, January 6. When I woke up on Thursday morning, my arm was red, swollen, and warm to the touch at the injection site, about 2 by 3 inches. It went away after 2-3 days, but returned on January 15, initially the exact same size and shape as the first reaction (we'd traced the edges to watch for spreading). It was warm, continued to expand and become more red and swollen, and was itchy, whereas the initial reaction had not been itchy. Since I work in a hospital, I was encouraged to see an NP at our Health Services department to make sure it wasn't looking like cellulitis, which she said it was not. I was given an antihistamine cream to use topically to relieve the itch. I was also told to see them again if it lasted more than 48 hours from that point. It was gone by January 17 or January 18.