chrisvoncsefalvay/vaers-outcomes huggingface dataset:
COVID related hospitalization after being vaccinated with Pfizer series + booster (9/17/2021, 3/25/2021, 3/4/21).  Admitted 3/7/22 to Hospital:  Presents with shortness of breath, fatigue and productive cough  Tested positive for Covid 3/2/2022    Chronically on 2L nasal cannula around the clock , on hospice care at long term care facility   On admission needed oxygen  3L nasal cannula  Given steroids for covid and antibiotics for possible community acquired pneumonia during hospitalization Receives 4mg of dexamethasone at baseline. Increased steroids during hospitalization Received IV hydration    Improved and back to baseline 2L of oxygen at discharge  Discharged 3/9/22
Very bad sore throat, 102 fever, swollen lymph nodes in neck.   Lots of crying.  Could not talk without pain.
Child distressed and screaming during vaccination process. Post vaccination pallor, sweating, and slow to respond. VS B/P 94/60 P 78 R 18.  Spontaneous recovery without treatment.
rash under my breasts that is very bad and red; body hives all over the place from head to toe; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: unknown), for Covid-19 Immunization, reaction(s): "I never had issue"; Bnt162b2 (DOSE 2, SINGLE, Lot number: unknown), for Covid-19 Immunization, reaction(s): "I never had issue". The following information was reported: URTICARIA (non-serious) with onset 20Sep2022, outcome "unknown", described as "body hives all over the place from head to toe"; RASH ERYTHEMATOUS (non-serious) with onset 20Sep2022, outcome "unknown", described as "rash under my breasts that is very bad and red".  Additional information: Caller received the Pfizer Covid-19 Bivalent vaccine on 12Sep at (facility name withheld). Caller reported that she has never ever had a problem with shots in her life. Yesterday 20Sep, she developed a rash under her breasts that was very bad and red, and she had body hives all over the place from head to toe. Caller was not sure if this was an adverse reaction to the vaccine, laundry detergent, soap, or something she ate. Caller provided that she received the Pfizer Covid-19 primary vaccines as well. Caller was querying what she should do about her body hives, if she should go to a dermatologist or her doctor. She was not allowed to return to work.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Post vax, the patient stated her head feels funny and a little light-headed. The patient was slightly pale and her skin was sweaty. The patient was put on the examining table to lay down with a cool cloth on her head.
Feel it's a little different; Swollen; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feel it's a little different) and PERIPHERAL SWELLING (Swollen) in a 92-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 063E21A) for COVID-19 vaccination.     Concomitant products included AMOXICILLIN, METOPROLOL, ACETYLSALICYLIC ACID (BABY ASPIRIN), ESCITALOPRAM OXALATE (LEXAPRO) and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On 19-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (Feel it's a little different) and PERIPHERAL SWELLING (Swollen). At the time of the report, FEELING ABNORMAL (Feel it's a little different) and PERIPHERAL SWELLING (Swollen) outcome was unknown.            Concomitant medications include cholesterol meds.
Allergies; did not feel well; This is a spontaneous report from a contactable consumer (patient).   A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: unknown) via an unspecified route of administration on 19Apr2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced allergies and did not feel well. The patient wanted to know where she could call to re-schedule her appointment for the second dose of Pfizer's COVID-19 vaccine, she received the first dose of the vaccine on 19Apr2021 and was trying to postpone her appointment for the second dose as she has allergies and does not feel well. She was supposed to get her second dose today. The outcome of the event was unknown.  No follow-up attempts are needed. No further information is expected.
Tachycardia. After about 5 minutes I felt my heart racing, it was about 125 beats per minute. It resolved within about 15 minutes on its own and I didn't mention it to anybody in the room other than couple of the people sitting around me. I just did some deep breathing and it went away.
extreme muscle fatigue confusion/disorientation patient fell out of bed and daughter was unable to help her get up; paramedics were summoned; patient transported to ER; next day patient had absolutely no memory of anything  that happened; she was totally confused as to why she was in the hospital or how she got there; two days later she is absolutely fine except for being very tired
This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No pertinent medical history and concurrent conditions reported. On an unknown date doses of VARVIAX (vial 1350U, were exposed to temperatures of -14.9c to -13c, 5 different times in the past 6 months, (duration of each excursion unknown), have been administered, subcutaneously . No other concomitant therapies reported. No adverse effect reported. The outcome of the events was unknown. The causality was not reported. No PQC reported. Additional information has been requested.
IgA nephropathy; Pericarditis; This literature-non-study case was reported in a literature article and describes the occurrence of IGA NEPHROPATHY (IgA nephropathy) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.    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 IGA NEPHROPATHY (IgA nephropathy) (seriousness criterion medically significant). an unknown date, the patient experienced PERICARDITIS (Pericarditis). The patient was treated with PREDNISONE for Pericarditis, at an unspecified dose and frequency. At the time of the report, IGA NEPHROPATHY (IgA nephropathy) and PERICARDITIS (Pericarditis) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood albumin: 4.1 g/dl serum albumin 4.1 g/dl. On an unknown date, Blood creatine: normal (normal) baseline SCr 1.1(mg/dl), 1.5 g/dl SCr 1.5(g/dl) and 1.4  g/dl SCr 1.4(g/dl). On an unknown date, Protein urine: 1.2 g/d 1.2 g/d and 0.3 g/d 0.3 g/d. On an unknown date, Red blood cells urine: 51-100 (/hpf) 51-100 (/HPF) and 3  10 (/hpf) 3  10 (/HPF).     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered IGA NEPHROPATHY (IgA nephropathy) and PERICARDITIS (Pericarditis) to be possibly related.    Patient responded to Prednisone treatment  Follow up time was reported as 5 months  Presenting symptom included Gross Hematuria  Concomitant product use was not provided by the reporter.    Company Comment: This is a literature case concerning a 66 year-old, male patient with no significant clinical history who experienced the unexpected serious events of IgA NEPHROPATHY. The events occurred unknown days after the first dose of COVID-19 vaccine.  The rechallenge was not applicable since only information about the first dose was disclosed  The benefit-risk relationship of Spikevax is not affected by this report.   This case was linked to MOD-2021-357261, MOD-2021-357610, MOD-2021-357611, MOD-2021-357612, MOD-2021-357613, MOD-2021-357614.   Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received by safety on 22-Oct-2021 included an Email with Agency received from team and does not contain any new information; Sender's Comments: This is a literature case concerning a 66 year-old, male patient with no significant clinical history who experienced the unexpected serious events of IgA NEPHROPATHY. The events occurred unknown days after the first dose of COVID-19 vaccine.  The rechallenge was not applicable since only information about the first dose was disclosed  The benefit-risk relationship of Spikevax is not affected by this report.
Adult patient who received a pediatric dose of Engerix-B; Adult patient who received a pediatric dose of Engerix-B; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 65-year-old female patient who received HBV (Engerix B) (batch number LX4XP, expiry date 6th January 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th April 2021, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 13th April 2021, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received a pediatric dose of Engerix-B which led to adult use of a child product and underdose. The reporter consented to follow up.
1 year old / received an adult dose; 1 year old / received an adult dose; This case was reported by a other health professional via call center representative and described the occurrence of overdose in a 1-year-old male patient who received HAV (Havrix 1440 adult) (batch number HA9Y9, expiry date 17th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th August 2021, the patient received the 1st dose of Havrix 1440 adult and Havrix Pre-Filled Syringe Device. On 13th August 2021, unknown after receiving Havrix 1440 adult and Havrix Pre-Filled Syringe Device, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The medical assistant reported that, a 1 year old patient received an adult dose of Havrix instead of a pediatric dose, which led to adult product administered to child and overdose  The reporter consented to follow up.
Ear infection requiring cefdenir antibiotic  Also concerns about heart ekg. Being referred to cardiologist
3-4 days after vaccination - (R) arm and hand had swelling. Has followed up with own physician and hospital, but unresolved. (R) Hand is visibly larger than left, swelling is at wrist area and forward. Has use of (R) hand but cannot make a tight fist.
Full multi-dose (3 dose) vial of 6mo -4 year vaccine given undiluted to patient during vaccine administration
Patient was seen in the clinic for a 2 month well-child check. He was inadvertently given a dose of MENACTRA (meningococcal) vaccine instead of PREVNAR (pneumococcal) vaccine. No adverse reaction has been reported.
Patient was only 17 years of age and given Moderna COVID-19 vaccine.  It is not approved for this use.
On way back to department developed numbness and tingling in the left thumb and 4 fingers.
Administration of an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) in a 67-year-old female patient 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of an expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant and treatment medications are provided by the reporter
Patient developed a macular rash within 15 minutes of vaccine administration. He did not have any respiratory symptoms, hives/induration or signs of anaphylaxis. Diphenhydramine 25 mg, orally, was administered immediately after the patient noticed the rash. It had already began to subside/resolve within a couple of minutes of taking diphenhydramine. He was evaluated by our medical doctor on site and left our vaccine clinic in no apparent distress.
Patient had pneumonia vaccine (PNEUMOVAX lot 1407Y) given on 10/15/10 and on 10/16/10 went to immediate care center with redness and swelling in Lt upper arm. Treated with IM PCN and given 10 supply of Dicloxacillin x 10 for cellulitis.
BODY ACHES; SORE THROAT; TIGHTNESS IN THE THROAT; CHILLS; FATIGUE; BAD HEADACHE; FEVER; This spontaneous report received from a patient concerned a 26 year old male. The patient's weight was 185 pounds, and height was 73 inches. The patient's concurrent conditions included: pollen allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient was healthy and had no medical conditions. The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 02-NOV-2021 for prophylactic vaccination. No concomitant medications were reported.  On 02-NOV-2021, the patient experienced body aches. On 02-NOV-2021, the patient experienced sore throat. On 02-NOV-2021, the patient experienced tightness in the throat. On 02-NOV-2021, the patient experienced chills. On 02-NOV-2021, the patient experienced fatigue. On 02-NOV-2021, the patient experienced bad headache. On 02-NOV-2021, the patient experienced fever. Treatment medications included: ibuprofen. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches, chills, bad headache, and fever, and the outcome of sore throat, tightness in the throat and fatigue was not reported. This report was non-serious.
This spontaneous report was received from a company representative referring to two patient of unknown age and gender. The patient's historical and concurrent conditions were not reported. There were no concomitant medications reported. On an unspecified date, the patients were vaccinated once with improperly stored doses of M-M-R II albumin status: recombinant human albumin (rHA) (dose, anatomical location and frequency were not reported) lot # N011005 and expiration date: 05-APR-2019, indicated for prophylaxis. Administered doses of vaccines experienced the temperature excursion of 11 degrees centigrades for 30 minutes recording by a data logger on unspecified dates. There were no previous excursions reported. No adverse effects reported.
After receiving my first covid vaccination I started my regular menses that lasted approximately 7 days. I then spotted off and on for a week after that. After my 2nd vaccination I started my next scheduled menses which lasted approximately 7 days. A week later, I started another menses that lasted another 7 days.  I've never had this happen in 40 years. My menses average about 5 days every 32 days. I feel its directly related to  the vaccine.
She got the shot at 8:45am, I took her to her babysitters, then picked her up at 6. At 6:30 I was giving her a bath and noticed the right thigh was super swollen(around 3x swollen), red with rash, and warm to the touch. Saturday morning, the 27, she woke up with red spots on her face. They were flush with the skin. By noon a few had shown up on her arms. They were gone Sunday morning. This past weekend, Sunday may 5, and again on Monday May 6, she had what looked to me to be minor seizures.
Pfizer Dose: 2; Moderna: 3; Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 26Sep2022 as dose 4 (booster), single (Lot number: GJ2524 SWY1523) at the age of 50 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 20Mar2021 as dose 1, single (Lot number: ER8733), in left arm and on 20Apr2021 as dose 2, single (Lot number: ER8732), in left arm for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 04Dec2021 as dose 3 (booster), single (Lot number: 058H21A), in left arm 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) all with onset Aug2023, outcome "unknown" and all described as "Treatment of COVID-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Pfizer Dose: 2; Moderna: 3". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The patient took the Paxlovid treatment from 19Aug2023 to 23Aug2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300293584 same patient, different drug and different AE.;
Information has been received from a physician concerning an 8 year old patient who on 07-APR-2000 was vaccinated with a first dose of varicella virus vaccine live (Oka/Merck). The patient has not received a second dose of varicella virus vaccine live (Oka/Merck). On approximately 26-FEB-2008, he presented to the physician with cold like symptoms, coughing for one day and then a rash appeared on the eyelid margin, lower left back, abdomen, and extremities. He had diffuse vesicles and rash, plus or minus pruritus. The physician is reporting the event as chicken pox. The physician indicated that no emergency visit was needed. At the time of this report the patient had not recovered. A product quality  complaint was not reported. Additional information has been requested.
Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Lymph Node Swelling-Severe, Systemic: Numbness (specify: facial area, extremities)-Severe, Systemic: Tingling (specify: facial area, extremities)-Severe, Additional Details: Second dose on 10/01/2021 Lot: FF2589 12/31/21 in right arm. All symptoms at this point still occurring. Patient did not speak up about symptoms to pharmacist until booster shot on 7/21/22 lot FP7150 exp. on 9/16/22 on right arm. Patient states she saw her doctor who would not provide an exception to getting the booster shot. Visual swelling on neck with goiter sticking out (never subsided after 1st dose) Tingling in left arm down to the fingers with pain in the upper half of the arm.
erythema muliforme 1 day p/Hep B vax afebrile-no other sx;
Rash about 3 inches wide developed on the mid-back. Also seems to be currently developing on right oblique. Very itchy.  Has been being treated by Benadryl.
After waiting in the waiting area for about 10 minutes the PT said he felt light headed and passed out falling to the floor. Mom was at his side and stated that he went to 'dead weight' and then she lowered him to the floor as best as she could. Mom said that she started 'shaking' and then stopped after about 15 seconds. After PT was stood up he felt like he was going to vomit but he did not. PT was extremely diaphoretic.
Pt recieved flu vaccine 10/11/20. Pt called back a couple hours later reporting rash on neck area. Pt advised to take 50 mg benadryl and monitor for worsening of reaction or swelling of tongue/throat or difficulty breathing and to seek medical attention if worsening occurs.
This was the two part Shingles vaccine. Mild flu like symptoms the next day. 102 fever in the evening. Cleared up by next day.
Left arm sore, pain in my neck and migraine, sore throat, runny nose, low grade fever 99.9,  extreme fatigue.  I am on day three and still having symptoms.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09Sep2022 as dose 5 (booster), single (Lot number: GH9702) at the age of 74 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Prostate Cancer in remission 6 years" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: COVID 19 Treatment. Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.
Within a week of receiving the second dose of the Moderna vaccine, I had the following adverse effects.  I was awakened from sleep by my teeth chattering rapidly.  This happened a couple of times a week for the first month, after the second dose.  Also, sometimes I would have facial spasms at the same time as the teeth chattering. Other times, only the facial spasms occurred.  The facial spasms have continued and are still ongoing.
Stuffed up, plugged ears, mild headache, off/on chills, no fever.  Started Monday night/early Tuesday AM.  Took over the counter meds (Vitamin C, D3 and CoQ10, generic pseudofed, Nyquil and Tylenol - starting on Tuesday night).  Went to the doctor Thursday late afternoon due to the pressure in nasal area/frontal area of head and fluid in ears.  Was given amoxicillin for sinus for 10 days and steroids for 5 days.
24-48 hrs p/ vax developed a rash, fever(103.6), lethargy & diarrhea. Pt exp dehydration & vomiting,was subsequently hospitalized & later recovered.  Prior vax w/ DPT was w/o incident.