chrisvoncsefalvay/vaers-outcomes huggingface dataset:
tested positive for covid yesterday; tested positive for covid yesterday; I am so sick; This is a spontaneous report from a contactable consumer (patient) or other non-health care professional.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 19Dec2020 as dose number unknown, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 07Sep2021 yesterday, the patient got that booster out and tested positive for covid and on an unspecified date in 2021 reported that patient was so sick and stated that we were no longer protected. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on 07Sep2021. Outcome of the events were unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
received their second dose of Twinrix 2 months after the initial dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 74-year-old male patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 31-JUL-2023, the patient received the 2nd dose of Twinrix. On 31-JUL-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: received their second dose of Twinrix 2 months after the initial dose). The outcome of the drug dose administration interval too long 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: 31-Jul-2023 The reporter provided limited information about the vaccine, patient and event. The patient received 2nd dose of Twinrix 2 months after the initial dose, which led to lengthening of vaccination schedule. The vaccine administration facility was same as the primary reporter. The reporter consented to follow up.
1 of 4 children immunized w/DTAP over the last 2 wks 11JUL-22JUL) who exp a rash around inj site (raised/swollen: approx. 1.5" diameter) None of the children reported itching, fever or other systemic rxns; rashes resolved w/in a few days;
cramp in left leg, pins and needles, cramping sensation; Her vision has been blurry/she cannot see anything close up anymore; worsened in intensity; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administration date 05Oct2021 (Lot number: FF2538) at the age of 60 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: FC3683 or EC3683), administration date: 12Sep2021, when the patient was 60 years old, for COVID-19 Immunization, reaction(s): "Nothing happened after the first dose.". The following information was reported: MUSCLE SPASMS (non-serious) with onset Oct2021, outcome "not recovered", described as "cramp in left leg, pins and needles, cramping sensation"; VISION BLURRED (non-serious) with onset Oct2021, outcome "unknown", described as "Her vision has been blurry/she cannot see anything close up anymore"; CONDITION AGGRAVATED (non-serious) with onset 2021, outcome "not recovered", described as "worsened in intensity".  Additional information:  Patient stated that after her second Pfizer covid vaccine, the second day she was in the car and had horrible cramp in her left leg. It was pins and needles, cramping sensation and electrical impulses like she has never felt, probably nerves.  No follow-up attempts are possible. No further information is expected.
ROBUST REACTION AT VACCINATION SITE, HARD KNOT 5 CM IN DIAMETER SURROUNDING ERYTHEMA, LOCALIZED REDNESS AND PAIN, FLU LIKE SYMPTOMS
This spontaneous report was received from a medical assistant regarding a patient of unknown age and gender. No concurrent conditions, medical history, allergy/drug reactions and concomitant medications were reported. On an unknown date, the patient was were vaccinated with improperly stored GARDASIL lot # K008931, expiry date: 04-MAR-2017 (dosing details, route of administration were not reported). It was reported that the vaccines were exposed to a temperature 30.9F during a time frame of 16 hours and 14 minutes. No previous temperature excursion was reported. There no product quality complaints (PQC) involved. This is 1 of the 2 reports from the same reporter. Additional information has been requested.
1 day after receiving vaccine both of my hands became cyanotic appearing (blue/purple). Outside of minor tingling sensation, I did not lose feeling of my fingers/hand and my capillary refill was normal. My 02 saturation remained at 100%
positive COVID 19 test after first dose of vaccination; positive COVID 19 test after first dose of vaccination; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date patient experienced positive covid 19 test after first dose of vaccination. It was reported that, patient stated that patient and a few of her coworkers all tested positive after they already had the first dose of the Pfizer COVID 19 vaccination. Patient and one other coworker have both tested negative now. Patient would like to know if she needs to start the series over again or if she can receive her second dose of the vaccine today. The patient underwent lab tests and procedures which included sars-cov-2 test: positive (She states that she and a few of her coworkers all tested positive after they had already had the first dose of the Pfizer COVID 19 vaccination) on unspecified date and sars-cov-2 test: negative (She and one other coworker have both tested negative now) on unspecified date.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Rash over entire body, except face started on 17 Apr 10 - Went ER on 17 Apr 10, quarantined for 4 hours to rule out smallpox.  BENADRYL & MOTRIN clinic visit on 19 Apr 10 - HYDROXYZINE - 25 mg RANITIDINE 150 mg.
Eight (8) hours post vaccination this patient's mother picked the child up to change her diaper; the child screamed and fought being handled. Seemed to be in a lot of pain. Her arms and legs were flailing but her trunk was limp. The patient could not sit or stand alone. Call to the MD. Went to the ER via ambulance. No temp, no injection site reaction. ER staff offered diagnosis of "transient reaction to vaccinations". Resolved 4 hours after onset. No treatment.
7/30--8/3 25 yo gentleman with history of obesity, mitral regurgitation admitted with fever, malaise, fatigue, weakness and hoome test positive for  COVID 19. Currently on room air. Non-hypoxic. Elevated inflammatory markers. Patient mid to the hospital seen by infectious disease placed in COVID isolation received IV Decadron remained stable and continued to improve had lower extremity venous Doppler CT of the chest negative for pulmonary embolism or DVT continue to improve was felt to be stable for discharge
38 years old male with no contributing comorbidities with one week of watery, brown, diarrhea, occurring about 2 times per day. There is no blood in the stool. There is not associated nausea.  No recent camping, travel, or antibiotic use. There are occasional mild abdominal cramps, but generally no pain. Symptoms are not worsened or improved by anything.  No fever. The patient has not been exposed to others with similar symptoms.  Patient states he received a COVID vaccination on Wednesday of last week afterward he got diarrhea and chills. He states his diarrhea has continued to this day, but chills cleared up after day 2. This patient's history and exam are consistent with viral syndrome and post vaccine mild reaction.
Fever of 101°f. Joint pain, Fatigue, Muscle aches. Beginning about 10 hours after vaccination. Lasting about 16 hours. Vomiting and diarrhea with fever of 99°f about 60 hours after vaccination.
Body aches began first along with fatigue .  Shortly thereafter a severe headache.  A couple hours later skin sensitivity also occurred.  The person administering the vaccine said not to take anything so I did not.  At 8:30 am the next day I called the doctor.  A nurse called me back around 3 in the afternoon(so it was 24 hours after onset) and said to take Motrin or Ibuprofen, which I did not have.  Did not take Motrin until 5:30.  Symptoms began to abate around 5.  Headache was the major issue from that point.  I took the 400mg as directed and did not take a second dose.  Headache was gone by 10:30 pm.  I am still tired as I'm filling out this form.  This was also the first time I was ever black and blue from a shot.
Radiating back pain Moderate neurological symptoms such as Numbness in hands and feet along with stiffness in my neck and back. Numbness in my tongue and rapid heartbeat. Extreme fatigue days after. Symptoms lasted for two weeks. All of these symptoms started the night of me receiving the vaccine. Prior to receiving I had not had these problems.  I had not had these reactions with the first two vaccines only the booster. Was given prednisone and muscle relaxants. My symptoms were drastically relieved with prednisone. The symptoms slowly went away as time went on the prednisone was the ultimate fix thank god.
Have suffered constant migraines where my right eye is blurry and starts to ache. Have missed work due to not being able to see with these migraines.
A non-serious report of administration of expired FluMist has been received from a nurse concerning a five-year old male. Neither medical history nor concomitant medications were provided. The patient received FluMist on 14-Mar-2008. The FluMist had expired on 10-Mar-2008. The reporter stated that she received 100 doses of FluMist from the Vaccines For Children Program on 22-Feb-2008 and the vaccine expired on 10-Mar-2008. The clinic did not realize the expiration date on the product and continued to give it from 11-Mar-2008 to 17-Mar-2008 to 26 patients. The patient had no adverse events at the time the report was received, neither as of 18-Apr-2008 when the office was contacted for follow-up information. The event has resolved. It was not reported whether or not FluMist was re-administered. The reporter provided no causality assessment for the event. The reporting source of this case is spontaneous, thus the sponsor's comment is not applicable. Follow-up information received 18-Apr-2008 and incorporated into the narrative: no adverse event occurred. This case is linked to the following 25 other cases reported from the same reporter: MEDI-0006660; MEDI-0006661; MEDI-0006662; MEDI-0006663; MEDI-0006664; MEDI-0006665; MEDI-0006666; MEDI-0006667; MEDI-0006668; MEDI-0006669; MEDI-0006670; MEDI-0006671; MEDI-0006672; MEDI-0006673; MEDI-0006674; MEDI-0006675; MEDI-0006676; MEDI-0006677; MEDI-0006678; MEDI-0006679; MEDI-0006659; MEDI-0006681; MEDI-0006682; MEDI-0006683; MEDI-0006684.
Right Shoulder Blade Swollen; Right arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Right Shoulder Blade Swollen) and VACCINATION SITE PAIN (Right arm pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Depression and Acid reflux (oesophageal). Concomitant products included SIMVASTATIN, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (HYZAAR) and GARLIC [ALLIUM SATIVUM] for an unknown indication.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Right Shoulder Blade Swollen) and VACCINATION SITE PAIN (Right arm pain). At the time of the report, VACCINATION SITE SWELLING (Right Shoulder Blade Swollen) and VACCINATION SITE PAIN (Right arm pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Other concomitant medication included cinnamon vitamins. Treatment information was not provided.
Pt came to doctors office complaining of sore arm where she had received Tdap 2 days prior.  R deltoid was swollen & red with 8cm x 7cm of induration & erythema present.  Hot to the touch & painful.  Pt states area is itchy.  Motrin & Benadryl cream recommended to pt.  Signs & symptoms of infection given to pt. & told to return if any problems or if problem did not resolve.
a 7 year old female patient received Quadracel vaccine in thigh/No AE; a 7 year old female patient received Quadracel vaccine/No AE; Initial information received on 31-Jul-2019 regarding an unsolicited valid non-serious case received from a physician (practitioner).  This case involves a seven and a half years old female patient received a 0.5ml dose of DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] vaccine lot number: C5500CA,expiry date 16-Aug-2020 via intramuscular route at right thigh on 04-Jun-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was a actual medication error due to inappropriate age at vaccine administration and vaccine administered at inappropriate site.  No adverse event reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error  List of documents held by sender: none.  Follow up information received on 02-Aug-2019 regarding an unsolicited valid non-serious case received from a physician (practitioner).  Batch number, expiry date, route and dose of vaccine was updated.  List of documents held by sender: none.
a drop didn't make it into his arm / possible underdose.; experienced arm pain (in the injected left arm) / isn't the "typical pain that you get" for a day or so / his arm hurt more than normal / is still a little bit there; it is not 100% resolved yet; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Covid-19 vaccine (received a Covid-19 shot in right arm months earlier from reporting day).   On 23rd March 2021, the patient received the 1st dose of Shingrix (intramuscular). In March 2021, less than a week after receiving Shingrix, the patient experienced pain in arm. On 23rd March 2021, the patient experienced underdose. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the underdose was unknown.   The reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The patient received Shingrix shot intramuscularly in the left deltoid and told that normally he gets immunizations in right arm but because he have received a Covid-19 shot in right arm months earlier, he decided to receive the Shingrix into his left arm instead.  The patient told that normally when gets a shot the patient did not flinch but with this Shingrix shot the patient did flinch and jump and due to that the pharmacist stated that a drop did not make it into arm, which led to possible underdose. The reporter was concerned about a possible underdose.  The reporter was wondering if the pharmacist might had used a longer needle than normal.  The patient experienced arm pain in the injected left arm after the injection.  The patient stated that it was not typical pain that get for a day or so after a shot, but that his arm hurt more than normal.   The patient was asked whether his arm pain had resolved at time of reporting to which he replied as there was still a little bit there and it was not 100 percent resolved. The reporter did not consent to follow up. The patient did not had a personal fax number and did not had the lot number and expiration date of the injection on the paperwork was given however the patient did provide pharmacy's contact information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR071417:same reporter(deleted)
Vaccine was administerd after being stored between 3.4°C  and 6.9°C for 76 days. Ten days at these temps was up on 5/26. Vaccine was administered on 6/1. Parent was contacted and reports child had  headache, injection site soreness, and non-specific symptoms for about a week. Child has history of  COVID infection. Received dose #2 on 6/22/22
Petechial/purpuric rash on both lower extremities, treated with Prednisone
It started as a scratchy feeling in my mouth on a Saturday. Then I called the doctor and they told me to come in and tested me I was negative to COVID. When my doctor came back, and he tested me I was positive to COVID. I was having dry cough that lasted for 3 to 4 weeks. The middle of last week it got to the point when I wasn't coughing at all. They said they was coming up with a lot of false tests. I was feeling like I had a cold.
This case was reported by a consumer via call center representative and described the occurrence of headache in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 4th April 2019, the patient received the 1st dose of SHINGRIX. On 4th April 2019, immediately after receiving SHINGRIX, the patient experienced headache, pain, pain in arm, flu like symptoms and shivers. On an unknown date, the outcome of the headache was recovered/resolved and the outcome of the pain was not recovered/not resolved and the outcome of the pain in arm, flu like symptoms and shivers were recovering/resolving. It was unknown if the reporter considered the headache, pain, pain in arm, flu like symptoms and shivers to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported but it could be 64 years or 65 years. The case was reported by the patient's sister who stated that the patient immediately started developing headache, achy and her arm was sore a little bit. The patient woke up in the middle of the night with shivers and flu like symptoms. The reporter stated that her sister was a private person and did not want to report the event.
I felt fine the whole time, but around a month after the vaccine I donated blood and shortly after that I got this letter from the Red Cross (April sometime) that I tested positive for syphilis, but they tested a second time and I didn't have syphilis. They then threw away my blood and I was furious because it was perfectly good blood. They told me to tell my Doctor and so I told him and he said they use a type of blood test for syphilis that may have detected the antibodies and since I had the shot recently they could have tested the antibodies from the vaccine.
Immediately after receiving vaccine,  R arm  twitched, pupils dilated, weak, in and out of responding. BP 98/60; HR 78; normally runs low BP.  Arm numb; throat tight. No welts; extreme fatigued. Rapid response; epinephrine given via epi pen; transported to ED.
I had COVID 12/25/2020:  My immune response was pretty strong after the first dose, as to be expected after recently having COVID - low grade fever, body aches, fatigue, sore arm, etc..  I am concerned though that 12 hrs after getting the vaccine, I had a VERY rapid heartbeat that woke me out of a sound sleep and kept me up all night.  I am hoping to avoid getting a second dose as I am worried about my response being even worse especially since I have had COVID.
Soreness at injection site - over the next few days, significant swelling of arm from elbow to shoulder, a band of red marks across half my arm, extreme soreness from elbow to shoulder, arm from elbow to shoulder is hot to touch.
Patient was given the booster bivalent shot instead of the primary series (patient was supposed to receive the 2nd shot)
Starting on 10/25/04 the following symptoms occurred upon waking in the morning: extreme pain and burning in both hands, especially at the finger tips, swollen hands and very swollen middle finger joint on right hand. Both hands were stiff, tingling, hard to make a fist/clench, and had a grainy sensation. Both hands were weaker and more uncoordinated than before the vaccine. I experienced colder hands now. My feet especially the toes were tingling, aching and very painful. My knee joints were also aching. About one week after the vaccine, I have had intestinal problems. My bowel movements have been looser and there is a bad smell to them, other than the usual. I feel achy in the intestines and more noise is in them, such as a rumbling noise. I have a lot more gas and my urine has a strange smell. These problems continue today. Since the vaccine, I have had a diminished appetite, and have lost weight. Every morning I wake with a bad taste in my mouth. As of November 1, 2004, the following is happening to me: I now have over all my body, a tingling sensation (from head to my toes), an overall body stiffening. My face has a tingling numb sensation in it. As of November 7, 2004 I woke in the morning with very painful knee joints. I continue to have very painful hands. Both hands have sensations of numbness, burning, grainy feeling, coldness, stiffness, tingling, poor coordination, and joint pain. Overall, my body feels stiffer and weaker, and more tired than normally. My knee joints are aching and my toes feel numb and tingling and painful. I feel my nerves have been attacked by the vaccine. All of my daily and/or normal activities are affected by this extreme condition in my hands and body. I have had MS for over 10 years, and I know that these are not the type of symptoms I would experienced from MS. Given the time of onset of these symptoms (2 weeks after the vaccine was administered), I believe the vaccine has damaged my body.  As of Dec2004: My Dr has determined that these events (above) are not MS related I continue to suffer in my hands and feet.
65 year old male received the 1st dose of the Pfizer COVID-19 Vaccine Lot# EN6205 at an unspecified park in county on 03/08/2021 @ 11:00. The evening of 03/08/2021 the pt started experiencing body chills, low-grade fever (<100 F), and headache. Pt describes headache as coming and going 2-3 times a day. Pt takes Tylenol 1-2 times a day. The low grade fever (<100 F) dissipated 03/17/2021. Headaches and body chills are still occurring. Pt called primary doctor for medical care, doctor  directed the pt to the CDC. Pt takes Amlodipine, Lisinopril, Rosuvastatin, and Gemfibrozil. Pt is diagnosed with Hypertension and Dyslipidemia. Pt denies allergies. Pt was advised to seek medical care due to the length the pt was been experiencing symptoms. SPI was consulted and Dr. was notified.  Date and time adverse event started:  Low-grade fever (<100 F): Started 03/08/2021 Evening - Stopped 03/17/2021 Headache and body chills: Started 03/08/2021 Evening - Still occurring  Pt called primary doctor for medical care, doctor directed the pt to the CDC.
Soreness; Fever; Hives on arm; swelling of arm; Extreme Fatigue.