chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nasal congestion; Fatigue; a little bit of headache; Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 50-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 09Oct2023 at 17:15 as dose 1, single (Batch/Lot number: unknown) at the age of 50 years for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for influenza immunisation, on 03Oct2023 as dose number unknown, single. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 immunisation. The following information was reported: COVID-19 (non-serious) with onset 14Oct2023, outcome "not recovered"; FATIGUE (non-serious) with onset 14Oct2023, outcome "not recovered"; NASAL CONGESTION (non-serious) with onset 14Oct2023, outcome "not recovered"; HEADACHE (non-serious) with onset 14Oct2023, outcome "not recovered", described as "a little bit of headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Caller was a 74-year-old male patient. Consumer calling about himself and his wife. Transferring agent stated the caller stated his wife and he both received the Comirnaty 2023-2024 vaccine on Monday 09Oct2023 at about 05:15pm within minutes of each other. This report was for the caller's wife. On Saturday she started developing symptoms and tested positive for a home test on Saturday 14Oct2023 for COVID; she had not had anymore testing done since then and the caller just assumed she caught it from him. She not had a regular clinic test yet. Caller was not an HCP but does worked in the medical community and had a company that supplied surgical and emergency care products. The caller declined full report on his wife as she was not there to consent and stated he had no lots, expiry dates, NDC numbers for her Comirnaty vaccine or for her prior COVID vaccines and had no names of her prior COVID vaccines or dated administered to provide but she had similar vaccine dates as the caller does. The caller's wife had nasal congestion, fatigue and a little bit of headache but no fever and those symptoms are ongoing and just persisting and her symptoms did not seem to be getting worse.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300331348 same reporter/drug, different patient/event;
I am not sure what is important, so I am going to try to describe everything I can remember from the last few days. I received my second vaccine last Saturday. After receiving the second vaccine I initially only had some soreness at the injection site. As the day progressed I began feeling increasingly fatigued, the injection site was more painful, and I began to get a headache. I went to bed around 10pm. I woke up several times throughout the night with either cold chills, or hot sweats, and body aches (my head continued to hurt). The next day (Sunday) I continued to have body aches, fatigue, nausea, headache, pain around the injection site, feeling weak, and discomfort under my left armpit. The area around the injection site felt swollen and hot to the touch. By the next day (Monday) I continued to feel nauseated, I had diarrhea, my head continued to hurt, and my arm continued to hurt and feel hot around the injection site. The following day, which was a Tuesday, I had a severe headache that developed into a migraine; I believed the side effects of the vaccine triggered a migraine. I felt nauseated, but this was likely due to the migraine itself. I continued to feel really tired, and did not have an appetite. The injection site still felt warm to the touch. I was out of work on Monday and Tuesday. I did return to work Wednesday, but I continued to feel fatigued, weak, and nauseated, as well as had a moderately bad headache (not migraine level). Today is Thursday and I finally feel back to normal.
Starting 06/18/2022, I developed symptoms like a more consistent productive cough and nasal congestion. It felt like a head cold. On 06/22/2022 I had to take a COVID-19 test due to me travelling and I tested positive. By then the productive cough was less productive, but still felt only like a cold to me. I did notice I was extra fatigued but had thought it was due to travelling. I have been getting better slowly but still having to cough about 5-6 times daily. I never had a fever and I didn't have shortness of breath, just of nasal congestion.
Severly sore arm, could not raise arm for approx. 3 days.  When laying down there is no comfortable position even when laying on opposite side.  IBUPROFEN, NAPROXEN sod.  did not help.  Also complained of sharp pains + tenderness.
Sore L arm and L Axilla, local redness, bump, whitish blister, local itching, local rash, headache, fever, muscle aches, feeling lousy, swollen lymph nodes.
Hallucinations, auditory and mild visual, insomnia, feeling of panic and fear of intruders and feverish, paranoia?ultimately resulting in me calling the cops on myself and making a false report and partial hospitalization. I was refused a blood test. And have had malaise and fatigue ever since.
inadvertently received a Expired dose of Imovax Rabies vaccine / no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 46 years old male patient who received 1 ml RABIES (HDC) VACCINE [IMOVAX RABIES] lot 1NK303M (Expiry date 28-Oct-2019) via intramuscular route in the left deltoid on 29-Oct-2019.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to Expired vaccine used.  At a time of reporting No adverse reaction reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's 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.
So, around 8:00PM that evening I had body aches, chills, severe headache and did not even want my clothes touching my body it hurt so bad. I was extremely tired. That lasted for two and half days and following that my asthma really started to bother me, really, big time. The asthma problem lasted a couple weeks to fully recover, I was put on a course of steroids and a nebulizer and took my Symbicort. I had contacted my doctor on Monday following my vaccine, the 8th, that's when it really got bad. I had a telehealth appointment due to COVID protocol. The other symptoms were gone at that point, it was the asthma that was lingering. It was difficult to just talk and breath or walk.
Employee states that about 7-8 days after injection her arm began to swell, become red, and painful. Employee states that she had limited ROM for 3 days. Employee feels that the injection site might not have been in the correct location.
Information has been received from a physician concerning a 4 year old pt who on 07/21/1995 was vaccinated with varicella virus vaccine live. The pt experienced breakthrough varicella on 05/23/1996 and 12/03/1998. There were less than 50 lesions. Unspecified medical attention was sought, but there  was no tX and no hospitalization. The pt recovered. No product quality complaint was involved. This is one pt out of 40 reported. Thrity nine other cases (WAES # 0407USA01446 and 0409USA01886 through 0409USA1893) experienced breakthrough varicella aftrer vaccination with varicella virus vaccine. Addtional information has been requested.
first dose to a 16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose to a 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose to a 16 year old). On 20-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (first dose to a 16 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Patient states that a red pimple like bump appeared on his face under the left eye.  The bump does not itch or hurt.
5 days later I had severe diarrhea, fatigue and a fever.; 5 days later I had severe diarrhea, fatigue and a fever.; 5 days later I had severe diarrhea, fatigue and a fever.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the left arm on 22Mar2021 at 10:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient previously had penicillin and had experienced penicillin allergy. The patient received concomitant medication within two weeks prior to vaccination which included fish oil (MANUFACTURER UNKNOWN) and multi vitamin (unspecified), both from unknown date and for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 27Mar2021 at 10:00, five days after the vaccination, the patient experienced severe diarrhea, fatigue and fever. No therapeutic measures were taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events severe diarrhea, fatigue and fever were resolved on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Strong headache every day, migraines, tiredness and weakness. Nausea and some dizziness.
Guillain-Barre syndrome; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. A female patient (not pregnant) received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (unspecified if ongoing). It was unknown if the patient had any allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient's concomitant medications were not reported. Past drug history included: Ivig, notes: IVIG. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization. Facility type was reported as vaccine Pharmacy or Drug Store. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant), outcome "unknown". The event "guillain-barre syndrome" required physician office visit.  The patient had developed Guillain-Barre syndrome sometime after her 2nd dose of the Pfizer- BioNTech COVID-19 vaccine this spring. She also received other vaccinations around that time period. The patient has multiple sclerosis (MS) and has received Intravenous immunoglobulin (IVIG) infusions. It was unknown if therapeutic measures were taken as a result of guillain-barre syndrome.  It was also reported that since the vaccination, the patient had not been tested for COVID-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
sore arm; Achy; Fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), PAIN (Achy) and PYREXIA (Fever) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 25-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm), PAIN (Achy) and PYREXIA (Fever). At the time of the report, PAIN IN EXTREMITY (sore arm), PAIN (Achy) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported  No treatment drugs were provided   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Non-Significant follow up received and contains no new information
was vaccinated / (22/07/2021) with the second dose / first dose was administered on 12/29/2020; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose on 29th December 2020).   On 22nd July 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 22nd July 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, 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 details were provided as follows: The Health care professional reported that, the patient received the first dose of Twinrix on 29th December 2020 and the second dose on 22nd Jul 2021, which led to lengthening of vaccination schedule. They had skipped the 1 month dose and received dose at 0 and 6 months instead of 0-1-6 month schedule.  The reporter consented to follow up. The vaccine administration facility is the same as primary reporter.
Headache fatigue, swollen lymph nodes Narrative:  employee states: she experienced a migraine the next day, extreme fatigue, and swollen lymph nodes on the vaccine arm
Red swelling and itching around injection site.  Hot to the touch. approx. 3"x4"
I21.4 ACUTE NON ST ELEVATION MI 4/17/2023 ACUTE NON ST ELEVATION MI CERVICAL RADICULOPATHY
24 hours after injection I momentarily blacked out---gash on right arm from hitting kitchen counter and pelvic pain/discomfort from fall.  At same time I had inflammation of both thumb joints--extremely painful and could not grip/lift anything without using both hands. That lasted for approximately another 12 hours and over the next 24 hours all inflammation and pain  gradually subsided.  I did not have any dizziness, disorientation or light headedness at time of blackout nor any joint pain. I have not had either since the initial episode.
Immediately upon having the injection administered, my heart rate sped up. I sat down within the waiting area for monitoring thinking that if I sat down for a bit, that it would  maybe pass . Within about 7 minutes of  that, I began to feel the back, left side of my throat go numb. I began to get very dizzy after that and I alerted one the pharmacy Nurses, that was on duty. She asked for me to open  My mouth so that she could see if my throat was swelling & said that she didn?t see anything and I was told by her that it may just be anxiety that I was experiencing and she asked me to take a few sips of water and to try and relax a bit. She resumed helping others, while I continued to sit there. It was then when I experienced a heavy onset of chest tightness and the inability to breathe. The left side of my face and jaw went numb & that?s when I really knew something was wrong. I was taken outside for some fresh air and realize that I was so nauseous, more dizzy, very weak upon standing and I told the same nurse and another young lady that was assisting me that I felt like I was going to pass out and to please call EMS for me . At that time, I lost temporary feeling in all 4 limbs  and I began to experience heart  palpitations . I was having some trouble swallowing and I was laid down and. My blood pressure was taken. Blood Pressure was 235/130 and it was taken several times until emts arrived. It was then 200/120 and 180/112 by the time help arrived. Overall I experienced burning sensation in chest and abdomen, facial weakness and numbness left side fever loose stools weakness, shortness of brEath and chest tightness blurred vision felt like I?m out of touch with reality Malaise restless and the loss in feeling in my Limbs are slowly returning body And  muscle and joint aches and pains and wheezing bouts
infected with covid within 10 days of 1st Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (infected with covid within 10 days of 1st Moderna vaccine) in a 76-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (infected with covid within 10 days of 1st Moderna vaccine). At the time of the report, COVID-19 (infected with covid within 10 days of 1st Moderna vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   Treatment information was not provided.
Severe headache, chills, significant fatigue, dizziness, unable to sleep. These effects continued for 4 days and subsided on  day 5.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42-year-old male patient received BNT162b2 (BNT162B2), on 16Mar2021 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 40 years, in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High-blood pressure" (unspecified if ongoing); "High cholesterol" (unspecified if ongoing). Concomitant medication(s) included: STRATTERA. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (14Jun2022) Positive, notes: being 5 day paxlovid treatment; (25Jun2022) Negative; (03Jul2022) Positive, notes: +ve RAT: Cough and runny nose, some fatigue; (04Jul2022) Positive, notes: +ve RATL w/ faint line, cough; (05Jul2022) Positive, notes: +ve RAT: w/very ver faint line cough dwindling; (06Jul2022) Positive, notes: +ve RAT: w/very dark line minor if no symptoms; (07Jul2022) Positive, notes: +ve RAT: w/very dark line minor if no symptoms; (08Jul2022) Positive, notes: +ve RAT: w/very dark line minor if no symptoms. Therapeutic measures were taken as a result of drug ineffective, covid-19 included paxlovid.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
5/19/13 Rash on upper lip and body twitching in arms and legs began. Severe canker sores in mouth began 5/28/13. On 5/31/13 body aches all over and mild fever of 99.3, nausea, weak. 6/1/13 cold and shivering all day, temp outside 90 degrees. Nausea, dizzy. 6/2/13 dizzy, hot and cold, shivering, un-responsive when talking to her. 6/3/13 so weak couldn't attend school. 6/4/13 admitted into the hospital, unable to walk.
Pt received 2nd dose of vaccine after 15 days AMA after being informed of CDC  recommendations.
lymph nodes under her left arm were swollen and black and blue; lymph nodes under her left arm were swollen and black and blue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), on 27Apr2022 as dose 4 (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: Covid-19 vaccine (DOSE 1, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 2, MANUFACTURER UNKNOWN), for Covid-19 immunization; Covid-19 vaccine (DOSE 3, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: CONTUSION (non-serious), LYMPHADENOPATHY (non-serious) all with onset 2022, outcome "unknown" and all described as "lymph nodes under her left arm were swollen and black and blue".  Additional information: The caller, also had a rough time with the vaccine.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Temperature 100.6; bad headache; body ache; stomach upset; nauseated; hard time concentrating; hard time understanding what you are saying; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 08Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious) with onset Apr2021, outcome "unknown", described as "Temperature 100.6"; HEADACHE (non-serious) with onset Apr2021, outcome "unknown", described as "bad headache"; PAIN (non-serious) with onset Apr2021, outcome "unknown", described as "body ache"; ABDOMINAL DISCOMFORT (non-serious) with onset Apr2021, outcome "unknown", described as "stomach upset"; NAUSEA (non-serious) with onset Apr2021, outcome "unknown", described as "nauseated"; DISTURBANCE IN ATTENTION (non-serious) with onset Apr2021, outcome "unknown", described as "hard time concentrating"; COGNITIVE DISORDER (non-serious) with onset Apr2021, outcome "unknown", described as "hard time understanding what you are saying". Relevant laboratory tests and procedures are available in the appropriate section. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt vaccinated with DTP after receiving his second DTP immunization, the pt developed fevers of 101-102. He also had an episode of vomiting, paleness, and lethargy.
Meningo given in (R) deltoid; Hep A given in (L) deltoid after hep A vaccine pt. past out, assisted to floor with feet above heart, cool compress given-this lasted several mins and then assistaed to w/c and monitored for 1/2 hr-given orange juice and mom drove pt. home.