chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a physician refers to a 12 months old male patient who on 24-SEP-2012 was vaccinated subcutaneously on left shoulder with a 0.5 ml dose of VARIVAX (Merck) (lot number reported as H007700, expiration date: 30-MAR-2014). No other co-suspects were reported. No concomitant medications were reported. The physician reported that the parent of the patient called the office on 29-SEP-2012 to report that the patient had a rash on his left shoulder, left side of his neck and left side of his chest. On 08-OCT-2012, the patient developed new spots so he went for an office visit. There were erythema and maculopapular spots on his arm pit, neck and anterior chest (all on the left side). There was no fever but the patient was fussy and clingy. On 24-OCT-2012, the patient went for another visit because the original rash had faded but there were new spots on his upper arm, neck and chest (all on the left side). The patient had a fever on approximately 23-OCT-2012, last night, of 102.7F. The physician reported that the rash was not a zoster rash. There was no treatment given for the events, there were no labs/diagnostic studies performed. At the time of the report, the patient had not recovered from the events. Additional information has been requested.
About 10 days or so after I received my 2nd Moderna vaccine, I started experiencing sharp and dull pain on the left side of my sternum/right side of my heart.  I thought it was indigestion or gas and did not relate it to the vaccine. But the symptoms persisted for about 2 weeks.  Also, the symptoms were different than anything I had felt before:  multiple times when walking up the hill on my street, I had to stop and wait for the pain to subside. My instincts told me that if I had kept walking something bad was going to happen. I also experienced the pain when sitting, laying down, etc. sporadically, for short periods - from a few seconds to minutes.
This spontaneous report as received from a consumer, who learned from a foreign radio channel of fatal cases after GARDASIL vaccination in one country (1210USA012211) and a second country (2 fatal cases, 1210HKG011628) and in a third country (3 fatal cases, this case). The reporter himself experienced serious adverse events (1210HKG011385). This report refers to three patients of unknown age. The patients were vaccinated with GARDASIL (date and route of administration not provided). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patients died. No details for death are available. The relatedness for death is unknown for GARDASIL. Additional information has been requested.
Chills, fever, body aches, diarrhea, nausea, temperature of 102.2, fatigue, sore arm with redness. Took Tylenol 8 hours into symptoms, majority of symptoms resolved within 24 hours. The redness and sore arm persists.
101F fever/101 degree fever; chills; headache; Sore arm; This is a spontaneous report from a contactable consumer reporting for herself. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via unspecified route of administration, on right arm, on 14Jan2021 15:30 at single dose for COVID-19 immunization. Vaccination Facility type was at Health department gave it at the fairgrounds. Medical history included ongoing COPD, blood pressure high, GERD, former smoker she quit 30 years ago, had COVID while she was in a rehab center in Aug2020, for which she said it felt like bronchitis; broke her hip last August (Aug2020). Ongoing concomitant medications included hydrochlorothiazide, telmisartan (TELMISARTAN HCTZ) for blood pressure high, pantoprazole for GERD, vitamins, ascorbic acid (VITAMIN C), zinc, colecalciferol (VITAMIN D), acetylsalicylic acid (ASPIRIN), magnesium. On 15Jan2021, patient had a 101F fever, a headache and chills all day. Her concern was that she had never had any kind of reaction to any kind of vaccine before. From what she's heard, people have had a worse reaction to the 2nd shot, and since the first shot was so bad she was worried about getting the 2nd one. She was scheduled for her 2nd dose on 02Feb2021, and she had an appointment scheduled with a specialist on 03Feb2021. The morning after getting the vaccine, she woke up and got dressed but kept thinking that she was cold so she put on an extra sweater. Stated that even with the extra sweater on, she still had the chills, then she started to get the headache, and then she took her temperature. Stated that she had also had a sore arm, it's finally starting to feel better today. The outcome of event sore arm was resolving, outcome of other events were resolved on 16Jan2021.
Patient was sitting in our observation area post-vaccination. Approximately 10-15 minutes after vaccination, she came back to the pharmacy counter stating she felt lightheaded and that she may pass out. I took her into our consultation room and had her lay down on the floor, gave her cold towels for her neck and a bottled water, and gave her a glucose tablet. I took patient's blood pressure and at that time was 99/62. She stated that her blood pressure normally runs low and that she hadn't eaten breakfast that morning. Patient laid there for about 5 minutes and started feeling better. I had her sit up, then took her blood pressure again. At this time, it was 105/70. Patient felt better and stated she would leave at that time.
This case was reported by a healthcare professional (also the subject) and described the occurrence of influenza symptoms in a male subject of unspecified age who was vaccinated with FLULAVAL (GlaxoSmithKline). In 2011 the subject received a dose of FLULAVAL. In 2011, less than one year after vaccination with FLULAVAL, the subject experienced severe influenza symptoms. At the time of reporting the outcome of the event was unspecified.
Forceful vomiting and diarrhea that lasted for around 13 hours.  I continually had unannounced diarrhea throughout this time and spent some time on the toilet with a waste basket in my lap as both things were happening at once.  Nothing would stay in my stomach until about 5:50 PM.  Then I was able to eat ice chips.  I tried eating a small bite of applesauce but I vomited that up.  I continued eating ice chips and the vomiting and diarrhea began easing up.  About 2 hours later I was able to keep water down.
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 73-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 29Jan2021 at 10:00 as dose 1, single (Lot number: EL9264), in left arm, on 19Feb2021 at 11:30 as dose 2, single (Lot number: EL9264), in left arm, on 24Sep2021 at 16:00 as dose 3 (booster), single (Lot number: FF8839), in left arm and on 31Mar2022 at 16:00 as dose 4 (booster), single (Lot number: FJ9943) at the age of 73 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "heart failure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: VACCINATION FAILURE (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: positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.Treatment of Anti-viral details for COVID 19 Treatment: Treatment start date10Aug2022 and Treatment stop date15Aug2022. Patient had no known allergy.  No follow-up attempts are possible. No further information is expected.
Patient reported that he felt that he had a good several hours of sleep only to realize that he had only slept for 15 to 30 mins. Patient still was after waking up. Patient stated that the this same feeling did occur when he received his first booster.
Inappropriate schedule of drug administration; no adverse effect.  Information has been received from a doctor of philosophy (PhD) concerning his 20 week old son who was vaccinated with the first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human bovine).  Unspecified medical attention was sought and no problems were reported.    Additional information has been requested.
Expired vial was stored in the refrigerator the day before administration; expired dose administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) and PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator the day before administration) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator the day before administration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired dose administered to patient) and PRODUCT STORAGE ERROR (Expired vial was stored in the refrigerator the day before administration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No information on concomitant medication was reported. It was reported that, the vials was initially stored in refrigerator a day before the administration and vials did not undergo any temperature excursions. The patient had not reported any adverse reactions to this dose.  No information on treatment medications was reported.   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2022: Follow-up information received contains no new information.
5 inch diameter swollen spot at injection site.m hot to touch. Swollen lymph nodes
Information has been received from a health professional concerning a 65 year old male with coronary artery disease, oesophageal reflux, hearing loss, herpes simplex type II, and drug hypersensitivity to acyclovir and ranitidine HCL capsules, who on 01-FEB-2008 was vaccinated IM with a 0.5 mL dose of pneumococcal 23v polysaccharide vaccine (lot# 659150/1384U). Concomitant therapy included aspirin, CIALIS, PRILOSEC, and omega-3 marine triglycerides. On 02-FEB-2007, the patient experienced body aches, low grade fever of 99-100F, sensitive skin and rash at the injection site. Medical attention was sought by calling the doctor's office on 04-Feb-2008. The patient's body aches and low grade fever of 99-100F and sensitive skin and rash at the injection site persisted. No product quality complaint was involved. Additional information has been requested.
Patient's daughter called the pharmacy and spoke to (staff pharmacist). Patient's daughter reported that patient is experiencing redness, swelling, pain on her left arm after receiving the PNEUMOVAX. We have been trying to get a hold of the patient yesterday but did not hear from them yet. Recommended that patient sees a doctor as soon as possible.
Vaccine vial was not diluted with the full dilatant amount.   Patient got more than the 30 microgram recommended dose due to the dose being concentrated.
VACCINATION ERROR: MCVB BEXSERO ADMINISTERED BUT  IS  NOT APPROVED VACCINE FOR 1 YEAR OF AGE.  MOTHER INFORMED 3 HOURS LATER AND PATIENT DID NOT HAVE ANY ADVERSE REACTIONS AT THAT TIME BUT MOM WILL BRING PATIENT  TO THE EMERGENCY ROOM AS A PRECAUTIONARY MEASURE.
Head ringing; Faint ringing in both his ears; This is a spontaneous report from a contactable consumer (patient, reported himself). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 02Jun2021 as a single dose for covid-19 immunization. The patient's medical history and concomitant medications, investigation assessment and other products were not reported. Patient previously took chemo treatment 2 years ago which caused head ringing, but it did not last longer. The patient stated that he looked at all the sheets and he did not have any of the side effects listed on the sheets. On an unknown date in Jun2021, he had a bit of head ringing and might be a day or two later he started to hear little bit of faint ringing in both of his ears, especially if things were quiet. He did not know if this was due to bit damp weather but the only thing, he had different in the last few weeks was getting his first vaccine. The patient stated that it was just weird, and he feels the chemo was all out of his system by now a year and a half later. The outcome of both the events was unknown.  Information about batch/lot number has been requested.
Heart palpitations, pvc?s,  lightheaded, pins and needles/deep itch, brain fog.  Also, after booster dose (3rd shot) i broke out in shingles on mid section.
This RN administered a flu vaccine to client's left deltoid. Client reported a "migraine" shortly after administration. Client denied any other complaints or complications. Client stated having a "long history of migraines, but didn't have one before getting the flu shot". Assessed client and injection site. Vital signs stable and within normal limits; Resp 16, Pulse 72,B/P 118/70. Injection site skin intact, no swelling, redness, or bruising present. Client denied the need for any follow-up.
patient muscle pains; spasms; This non-serious case was reported by a nurse via sales rep and described the occurrence of muscle pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, immediately after receiving Arexvy, the patient experienced muscle pain (Verbatim: patient muscle pains) and spasms (Verbatim: spasms). The outcome of the muscle pain and spasms were not reported.   The reporter considered the muscle pain and spasms to be related to Arexvy.     The company considered the muscle pain and spasms to be related to Arexvy.   Additional Information: GSK Receipt Date: 16-OCT-2023 The reporter stated that the Arexvy caused the patient muscle pains and spasms immediately following vaccination. It was not sure if the reporter agree to follow up from GSK.
Information has been received from a physician concerning a 10 year old female with a history of migraines who on 13-MAR-2007 was vaccinated with Gardasil. There was no concomitant medication. On approximately 16-MAR-2007, 'within 3 to 4 days", the patient developed an itchy, papular rash on her face, extremities and body. The patient sought medical attention and was treated with Benadryl. Subsequently, the patient was recovering. The product quality complaint unit was not involved. Additional information has been requested. The physician also provided information regarding another patient's experience with Gardasil (WAES#0704USA01626).
Pt. developed wheezing & severe stuffy nose 3 1/2 hrs. after vaccine administered. She was seen after hours at local clinic & given BENADRYL. She called next am to report & stated symptoms resolved.
This spontaneous report was received from a healthcare worker concerning to a female patient of unknown age. The patient's concurrent conditions, medical history, drug allergies/reactions, and concomitant therapies were not provided. On 23-MAR-2017 the patient was vaccinated with an expired dose of PNEUMOVAX23 lot # L012215, with expiration date of 13-JAN-2017 for prophylaxis (the route, dose, frequency, and strength were not provided). No adverse effects were reported. Additional information is not expected because there was no consent to contact physician.
Approximately over a 100 patients were administered with doses past the 30 days expiration date.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Approximately over a 100 patients were administered with doses past the 30 days expiration date.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) 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) (unknown route) 1 dosage form. On 13-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Approximately over a 100 patients were administered with doses past the 30 days expiration date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Approximately over a 100 patients were administered with doses past the 30 days expiration date.) 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.
This spontaneous report as received from a medical assistant refers to an 11 year old male patient. The patient had no pertinent medical history and drug reactions/allergies. On 28-AUG-2017, the patient was vaccinated with GARDASIL 9 (strength, dose and route of administration were not reported) lot/batch#N010497, expiration date 15-JAN-2020 for prophylaxis. Concomitant therapy included methylphenidate hydrochloride(CONCERTA but reported as CONCENTRA). On 28-AUG-2017, approximately 1 minute after receiving GARDASIL 9, the patient didn't "feel good" and he became "disorientated, stood up and walked into a wall". The patient "then became unconscious and his lips and nose turned blue". It was reported that the physician "began cardiopulmonary resuscitation(CPR) and continued until the patient woke up which was about 30 seconds later". Emergency Medical Services(EMS) had been called "but the patient did not go to hospital and eventually walked out of the office on his own. The patient was given treatment for the reported adverse events. No lab diagnostics/studies were performed. The outcome of the events was reported as recovered approximately on 28-AUG-2017. The causality assessment was not provided by the reporter. There was no product quality complaint (PQC) involved. The reporter considered the events to be medically significant and life threatening.
terrible pain; Initial information received on 27-Jan-2021 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional (reference number: US-SA-SAC20210204000817).  This case involves a patient (age and gender not reported) who experienced terrible pain (pain), while he/she received INFLUENZA VACCINE.  Medical history, past medical treatment, past vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious terrible pain (pain) (unknown latency) following the administration of INFLUENZA VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome reported as unknown for the event.  There will be no information available on batch number for this case.
swollen lip; Swelling started on the right side of her mouth.; This spontaneous case was reported by a patient and describes the occurrence of LIP SWELLING (swollen lip) and MOUTH SWELLING (Swelling started on the right side of her mouth.) in a 72-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 027822A) for COVID-19 prophylaxis.     The patient's past medical history included Fall (Patient fall in garage) on 21-Aug-2022, Shoulder dislocation on 21-Aug-2022 and Ischemic stroke (Mild) in 2014. Concurrent medical conditions included Multiple sclerosis and Lupus syndrome. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), LOSARTAN, ASPIRIN [ACETYLSALICYLIC ACID], CLONAZEPAM, PREGABALIN (LYRICA), VITAMIN B12 [VITAMIN B12 NOS], COLECALCIFEROL (VITAMIN D3), PARACETAMOL (TYLENOL), CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) and CLONAZEPAM for an unknown indication.    On 18-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 19-Oct-2022, the patient experienced LIP SWELLING (swollen lip) and MOUTH SWELLING (Swelling started on the right side of her mouth.). At the time of the report, LIP SWELLING (swollen lip) and MOUTH SWELLING (Swelling started on the right side of her mouth.) outcome was unknown.            Patient took first dose of moderna on 29-JAN-2021, lot number 028L20A on left arm, 2nd dose on 01-MAR-2021, lot number 014M20A on left arm, First booster dose on 31-AUG-2021, lot number 051E21A and second booster dose on 20-MAY-2022, lot number 054A22A on left arm.  Treatment medication was not provided by the reporter.   This case was linked to MOD-2022-661321 (Patient Link).
Patient noticed on day 7 following the vaccine administration: pain, redness, swelling of the area.  On day 8, the redness and swelling of the area became larger.  The area of erythema measured 21 cm X 22 cm respectively.  There was also an area of induration.  The patient contacted me and sent me a picture.  I advised him to go to the nearest ER or urgent care for proper evaluation. Patient went to urgent care on 16 January 2021  and was seen by a physician assistant. No test were performed other than a physical exam.  Patient was diagnosed with "Local infection of the skin and subcutaneous tissue (686.9)Patient was given an injection of 450 mg Clindamycin and given a prescription for Clindamycin.
Pain at shot site (expected); unexpected side effects - missing 2 days of work for fever, chills, stomach nausea, headache, muscular and lymph node pain along right side and under arm, severe tiredness.
Patient received Moderna Covid Vaccine # 1 from pharmacy on 9/12/2021. Reports that 2 days after the injections she started experiencing symptoms of pain at injection site, swelling, redness, itching, fever, developed a large knot at injection site. She notified Pharmacy of symptoms and was advised to continue to monitor, take ibuprofen and benadryl.  Symptoms improved minimally. Since injection, symptoms have progressively gotten worse. She now c/o difficulty lifting left arm above her head or gripping, severe itching which is worse at night. Symptoms have now been present for almost four weeks.
I had a little sore throat on the 9th, by the 10th I still had a sore throat but tested negative. On Saturday I still did not feel well but I had tested negative with a home COVID-19 test. On Monday I tested again as I was going to be around a group of people. I had developed a runny nose and hard palate in my mouth by Thursday was hurting. After I tested positive I emailed my doctor with my results she sent a prescription in for the PAXLOVID that I started taking on Tuesday morning. By Friday I was testing negative and was back to work.