chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 at 15:30 as dose 5 (booster), single (Lot number: 9H9697) at the age of 72 years, in right 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: "Hypothyroidism" (unspecified if ongoing); "Dilaudid allergy" (unspecified if ongoing); "Cephalexin allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received treatment of Paxlovid for COVID-19 from 14Apr2023 to 19Apr2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300166748 Same patient, different drug/AE.;
Patient developed a red, burning rash on his hip two weeks after receiving the SHINGRIX vaccine. Patient's doctor stated that the rash appeared to be mild shingles.
Started as a knot, itching and red on right arm. It lasted for 4 days. Took a benadryl twice/
stroke; blood clot occurring in the brain; This is a spontaneous report from a contactable consumer. A 70-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EN6200), dose 1 via an unspecified route of administration, administered in arm left on 19Feb2021 11:00 (at the age of 70-year-old) as single dose for COVID-19 immunization. The patient's medical history included 50% blockage of artery, thyroid disorder, hyperlipidemia. No known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications the patient received within 2 weeks of vaccination included statin and thyroid. The patient experienced stroke on 22Feb2021 00:30 with blood clot occurring in the brain. On a scale of 1-10, it was a 1 or 1.5 per physician and originated in speech area. AEs resulted in emergency room/department or urgent care, and hospitalization (1 day). Patient received Clotbuster as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in 2021.
Reported induration at injection site, warmth at injection site, wheal at injection site. On June 5th 2000 the patient experienced a local reaction to vaccine, red welt on the arm that was warm to touch. The area was 1 1/2 x 2 1/2 cm and hard
This case was reported by a physician via call center representative and described the occurrence of vesicular rash in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 2nd August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 5th August 2018, 3 days after receiving SHINGRIX, the patient experienced vesicular rash. On an unknown date, the outcome of the vesicular rash was not recovered/not resolved. It was unknown if the reporter considered the vesicular rash to be related to SHINGRIX. Additional details were provided as follows: The patient was vaccinated at a pharmacy. She was at the physician's office at the time of reporting, with what looked like shingles.
Vaccine on the 6th  Sore arm that day.    That night before bed dizzy, tired, back muscles tightening.     7th. Dizzy , tight muscles, sore arm,  that late afternoon i sneezed.  My back went out.    Severe spasms and pain from The 7th-16th.     Late night on the 16th.  Chest neck and shoulder pain.   Heart flutters, tachycardia, oxygen levels dropping to 89.  Hovering around 95. Severe  nausea.   Abdomen pain.    Tight painful muscles in legs   Same and worse today on the 17th , had ER visit   Been taking Valium and Tylenol for pain and spasms per my PCP since April 15
Rash started within 15 minutes of injection, flushing to ears, itching, hives. Self treated with BENADRYL before returning to office.
Fatigue, headache, chills, fever and nausea were noted 11hrs  after injection. Symptoms lasted approximately 24hrs. Symptoms peaked after 8 hrs after onset and gradually resolved by 24hrs after onset of symptoms.   (I got my shot at 10am friday. Symptoms began by 11pm that night. Symptoms peaked at 7am Saturday then resolved by 11pm Saturday)
unable to walk; back aching; slept all day; This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (unable to walk), BACK PAIN (back aching) and SOMNOLENCE (slept all day) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Walking difficulty (can't walk without a walker) since an unknown date.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 GAIT INABILITY (unable to walk), BACK PAIN (back aching) and SOMNOLENCE (slept all day). At the time of the report, GAIT INABILITY (unable to walk), BACK PAIN (back aching) and SOMNOLENCE (slept all day) outcome was unknown.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Consumer feels fine. No problem at all This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 25-Feb-2021 and was forwarded to Moderna on 26-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of GAIT INABILITY (unable to walk), BACK PAIN (back aching) and SOMNOLENCE (slept all day) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination.     The patient's past medical history included Walking difficulty (can't walk without a walker) since an unknown date.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 GAIT INABILITY (unable to walk), BACK PAIN (back aching) and SOMNOLENCE (slept all day). At the time of the report, GAIT INABILITY (unable to walk), BACK PAIN (back aching) and SOMNOLENCE (slept all day) outcome was unknown.            No relevant Concomitant medications were reported.   No Treatment information for the event was provided.    Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: Consumer feels fine. No problem at all
he has chills; my husband has been throwing up, he can't keep anything down; nauseous; my husband is feeling really bad; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (my husband is feeling really bad), CHILLS (he has chills), VOMITING (my husband has been throwing up, he can't keep anything down) and NAUSEA (nauseous) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced FEELING ABNORMAL (my husband is feeling really bad) and NAUSEA (nauseous). On an unknown date, the patient experienced CHILLS (he has chills) and VOMITING (my husband has been throwing up, he can't keep anything down). At the time of the report, FEELING ABNORMAL (my husband is feeling really bad), CHILLS (he has chills), VOMITING (my husband has been throwing up, he can't keep anything down) and NAUSEA (nauseous) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication were provided
Headache; some pain in the same gluteal muscle; some pain in the same gluteal muscle; little achiness; This is a spontaneous report from a contactable consumer (patient). A 72-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on unspecified date of Feb2021 (4 weeks ago from 12Mar2021) as 1st dose, single for covid-19 immunisation. Medical history included previous injury from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported.  The patient previously took Pristiq 1 year ago and had to gradually increase her dose but eventually had a reaction to it, patient had a very severe pain in her left gluteal muscle. Patient supposed it was there due to a previous injury, but it only showed up when patient increased the (Pristiq) dose and went away when patient got off of it. On unspecified date of Feb2021 (in the first day or two after vaccination), besides some little achiness and headache, patient also had some pain in the same gluteal muscle, it was not nearly as severe, it did not last more than a day or two. Patient 2nd COVID-19 vaccination was scheduled for tomorrow (13Mar2021). It was stated that polyethylene glycol was an ingredient present in Pristiq and was also part of the molecule in a vaccine ingredient. Patient was referred to a healthcare professional/the vaccination provider for additional guidance before vaccination, if she considers she had an allergic reaction to Pristiq and was concerned she may develop a similar reaction after the 2nd COVID-19 vaccine dose, suggested to mention her clinical history, allergies and other conditions. Patient asked what were the symptoms of an allergic reaction to the Pfizer-BioNTech COVID-19 vaccine, was muscle pain (gluteal muscle) one of them and in response it was mentioned that the incidence of muscle pain in patients above 56 years old. The outcome of the events was recovered on an unspecified date of Feb2021.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
About week after shot, became extremely weak , fatigued , and am showing signs of vestibular neuritis (vertigo , feeling as though I would pass out, blurred vision , head ache , ear pain)
This spontaneous report as received from a registered nurse refers to a 7 year old female patient. On 18-DEC-2013 the patient was vaccinated with GARDSIL (lot # J012212, exp date 18-FEB-2016), 0.5 ml, intramuscular. The nurse reported that patient received GARDASIL, meant for her older sister, in place of flu vaccine. No adverse effect. Additional information has been requested.
After patient left and was in parking lot, patient became lethargic. Mom brought him in. He was not alert but awake, lethargic. Initially bradycardic, not hypoxic, pale. Administered O2 and BENADRYL. 15 min later was completely himself, paramedics took him to ER - blood work normal and was released home.
Patient has been having abdominal cramping with uncontrollable diarrhea for three days following his first COVID vaccination. He is eating a bland diet with yogurt, but has been passing bloody, loose stools every 30-40 minutes. He notified his PCP, who prescribed him an antibiotic for possible diverticulitis flare.
Pt. stated, "I felt like I was going to faint."  "I'm afraid of needles and most of the time I faint when I get a vaccine."  Vital signs done BP 112/80, O2Sat 100%, R 16, glucose 82.  Pt. is alert and oriented x4.  At 3:39pm she stated, "I'm feeling better."  At 3:57pm she stated, "I feel ok now, I'm ok to go home."  Pt. refused to go to the hospital.  She stated, "I'm good now, I'm going to wait for my family member to drive my car."
This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 19-FEB-2018, the patient was vaccinated with ROTATEQ (strength, dose and frequency were not reported) (lot # M005619, expiry date: 29-OCT-2018) orally for prophylaxis (product storage error). The vaccine was stored at 34 degrees Fahrenheit (F) for 12 hours. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion. No adverse effects were reported. No additional information provided. There was no product quality complaint (PQC) reported. This one of 6 reports received from the same reporter. Lot number [M005619] is an invalid lot number for ROTATEQ. Sender's Comments: US-009507513-1803USA003815: US-009507513-1803USA003817: US-009507513-1803USA003814: US-009507513-1803USA003816: US-009507513-1803USA003813.
he has Covid starting around 28Dec2021 through 04Jan2022; he has Covid starting around 28Dec2021 through 04Jan2022; he might have a breakthrough infection way back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 70 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Hepatitis b; Hiv. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "he has Covid starting around 28Dec2021 through 04Jan2022"; INFECTION (non-serious), outcome "unknown", described as "he might have a breakthrough infection way back".  Clinical course: Patient would like to inquire on how to volunteer on getting the Omicron specific vaccine clinical trials. He mentioned that he already got the 3 doses of the Pfizer covid-19 vaccine. He would like to know whether or not he will be an acceptable candidate. He also mentioned that he might have a breakthrough infection way back and was advised that if he continues to get weird symptoms, He needs to get tested but he was never tested. He also mentioned that he has Covid starting around 28Dec2021, through 04Jan2022. Patient also mentioned he was a volunteer of many vaccine trials for Hepatitis B and C as well as HIV.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Started to feel tired a few hours after the vaccine with slight aches. I had a fever by the time I went to bed. The entire night was spent tossing and turning, drenched in sweat while simultaneously feeling like I was on fire. On top of this I had a massive headache. Today is the day after and my fever has gone down throughout the day, but it is pretty bad. I still have a headache and also vomited a few times today. I have been taking acetaminophen and took some pepto bismol. I was able to start eating later in the day.
Pt. reported to ER 53 hours post-vaccination with redness, swelling and itching of proximal left arm. Site warm to touch. Home on BENADRYL and ice packs. Treated with KEFLEX for possible early cellulitis.
Deltoid mildly puffy and warm. Also itching. Treatment ice and Tylenol.
chest pain; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain) and VOMITING (vomiting) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81), VERAPAMIL, LOSARTAN, SERTRALINE, HYDROCHLOROTHIAZIDE, CETIRIZINE HYDROCHLORIDE, FLUTICASONE PROPIONATE, VITAMIN E NOS and VITAMIN D3 for an unknown indication.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, the patient experienced CHEST PAIN (chest pain) and VOMITING (vomiting). At the time of the report, CHEST PAIN (chest pain) and VOMITING (vomiting) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications also included silver centrum. Treatment details was not reported by the reporter.
Woke up on Sunday morning around 3:30AM and my throat was scratchy and hurt some.  When I got up at 8:30 AM, I was still feeling the same but ate some dry cheerios and it did not hurt swallowing.  I do not have a temperature(97.9).  I was not sure if I should be concerned  about this.
weakness; Headache; Fever 103.5; Extreme fatigue; Strong shoulder pain; chills; Injection site pain; Brain fog; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Brain fog), ASTHENIA (weakness), HEADACHE (Headache), PYREXIA (Fever 103.5) and FATIGUE (Extreme fatigue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011A21A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Palpitation in 2016. Previously administered products included for an unreported indication: SHINGRIX (second shingrix 50mcg vaccination) in January 2020. Concurrent medical conditions included Thyroid disorder NOS since 2002, Blood pressure high since 2017 and High cholesterol since 2012. Concomitant products included LOSARTAN and ACETYLSALICYLIC ACID (ASPIRIN 81) for Blood pressure high, SIMVASTATIN for High cholesterol, LEVOTHYROXINE for Hypothyroidism, ATENOLOL for Palpitation.   On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced FEELING ABNORMAL (Brain fog), HEADACHE (Headache), PYREXIA (Fever 103.5), FATIGUE (Extreme fatigue), ARTHRALGIA (Strong shoulder pain), CHILLS (chills) and INJECTION SITE PAIN (Injection site pain). On 05-Mar-2021, the patient experienced ASTHENIA (weakness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 05-Mar-2021, FEELING ABNORMAL (Brain fog), HEADACHE (Headache), PYREXIA (Fever 103.5), FATIGUE (Extreme fatigue), ARTHRALGIA (Strong shoulder pain), CHILLS (chills) and INJECTION SITE PAIN (Injection site pain) had resolved with sequelae. At the time of the report, ASTHENIA (weakness) had resolved with sequelae.            This case was linked to MOD-2021-019707 (Patient Link).
4/24/16 Patient noticed that her upper arm that she received a PREVNAR vaccination on 4/18/2016 was red and had pain when she lifted her arm. She reported mild swelling of upper arm. No itching, no fever. She visited her physician, he suspected an infection and placed patient on oral antibiotic treatment.
Patient received AFLURIA flu shot 1-30-18. Sad got hot - dizzy - went away within 15 minutes.
This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got very sick), PAIN (heaviness in my body), BEDRIDDEN (could not leave bed), PHYSICAL DISABILITY (Could not get up) and CHEST DISCOMFORT (felt a heaviness in my chest) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 07-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, the patient experienced ILLNESS (got very sick), BEDRIDDEN (could not leave bed), PHYSICAL DISABILITY (Could not get up), PARALYTIC DISABILITY (felt paralyzed), HEAD DISCOMFORT (heaviness on my head) and DYSPHAGIA (could not drink anything). On 08-Apr-2021, the patient experienced PAIN (heaviness in my body), CHEST DISCOMFORT (felt a heaviness in my chest) and DYSPNOEA (had trouble breathing/difficulty breathing). On 11-Apr-2021, CHEST DISCOMFORT (felt a heaviness in my chest) and DYSPNOEA (had trouble breathing/difficulty breathing) had resolved. In April 2021, PAIN (heaviness in my body), BEDRIDDEN (could not leave bed), PHYSICAL DISABILITY (Could not get up), PARALYTIC DISABILITY (felt paralyzed), HEAD DISCOMFORT (heaviness on my head) and DYSPHAGIA (could not drink anything) had resolved. At the time of the report, ILLNESS (got very sick) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.  At 4AM on the third day I was fine, was reported.   This case was linked to MOD-2021-435257 (Patient Link).
Information has been received from a nurse, who is also the patient's mother, regarding a 27 year old HIV-positive male with asthma and history of pneumonia, who was administered PNEUMOVAX 23 on 17-SEP-2012. Concomitant medication included rescue inhaler and steroids on occasion. On 18-SEP-2012, the patient experienced "soreness, tenderness, pain and swelling at the injection site, as well as it being warm to the touch. In addition, he experienced fever, chills, and fatigue." The patient was treated with TYLENOL. The present patient status was that he was recovering. No further information is available. Additional information is not expected.
Moderna.   Just want to report that after the shot  the next day my urine began to turn rosy red. I think it is a reaction to my Eliquis. And that is what I want to report.
Patient had what appeared to be a vasovagal reaction.  She complained of feeling light-headed and nauseous about 5-10 minutes after receiving the vaccine.  This continued for a short time and she also began to complain of feeling chilled and was noticeably diaphoretic.  I monitored her blood pressure, which was low on the initial reading and then eventually came up to a reading of 89/60 with a pulse of 73 at the point that her symptoms began to subside.  By approximately 45 minutes after the episode began, she reported feeling better and was able to stand and walk without symptoms.  She went home at that time with a friend.
Vertigo/dizziness; getting better at 1/27 11AM but still experiencing spells of dizziness
Informed on 1/12/02, at 12:30, that the child had died. Cause of death was determined to be SIDS by ER doctor. He called me as a courtesy notification. The child apparently was found blue and not breathing at home. COD as per autopsy report -- SIDS
I received the Covid vaccine at around 11AM on 3/25/21. I was waken out of my sleep around 2AM with a severe headache, chills, body and joint aches, nausea, diarrhea and a fever of 99.2. It was difficult to even get out of the bed and go to use the bathroom. The next day these symptoms continued but my headache worsened. I could not even eat a spoonful of soup or eat some Italian bread. as of 3/26/21, 4PM, I am still experiencing all of those symptoms except gastric .