chrisvoncsefalvay/vaers-outcomes huggingface dataset:
the 1st shot i just had pain in arm and tired.  The 2nd shot Pfizer not good, about 8 pm i started feeling out of breath and had no energy and my arm hurt when tried moving it,took tylenol for  the pain it didnt help.  at 1am wednesday i started getting chills and decided to take a bath as i went toshut the water off with my foot i couldnt move my legs and or arms from my shoulders down i felt paralixed i started to yell for my fiancee and my son as i was starting toswallow water and kept spitting it out until the last scream i screamed for help and the next thing i knew i was being pulled up out of tub and my fiancee was smacking me in back and i threw out water and breated again ,he says my eyes were open under the water but i was gone .he picked me up and briught me to bed .i slept alittle he said but i constantly was in pain my whole body hurt i couldnt  move to quick. my 6 year old son was so scared to fall asleep cus he was scared i was gonna die. i slept off and on all day wednesday and at 615 pm i fell asleep and didnt wake up til 530am thursday. im now numb and tingky thelast 2 days
Site: Pain at Injection Site-Severe, Additional Details: pt unable to move arm completely, locked, and pain at injection site
Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in 2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Consumer reports an 'awful taste' from the Paxlovid. She states that she's had her Pfizer COVID 19 vaccine and her booster.". Therapeutic measures were taken as a result of drug ineffective, covid-19.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.
No adverse event reported with the patient. Patient received two ZOSTAVAX shots. 1 shot on 7-18-16 and 1 shot on 7-31-16.
Sore, swollen injection site -- continues 3rd day Nausea -- OK after 1st day Headache -- continues 3rd day Fatigue -- continues 3rd day Body Ache -- continues 3rd day Stiffness -- continues 3rd day Slow thinking -- OK after 1st day Labored breathing -- OK after 1st day
About 9 hours after receiving second dose of Moderna, I felt flu-like but I needed to get up and go to the restroom.  By the time I got to the bathroom door, I knew I was going to pass out so I grabbed the sink and gently slid to the floor to lay on the cold tile.  I did not pass out and was able to call out for my husband.  I couldn't move and I rolled over and threw up.  I stayed on the floor for a long while but eventually made my way back to the bed and just laid down.  I stayed nauseated for a while but never felt like I was going to pass out.  It took until the afternoon of the next day to start feeling like I was able to be mobile.
Injection site pain; Running nose; Sinus; Just like flu; Feeling exhaustion; Chills; Headache; bump on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (Running nose), SINUS DISORDER (Sinus), INFLUENZA LIKE ILLNESS (Just like flu), INJECTION SITE PAIN (Injection site pain) and INJECTION SITE SWELLING (bump on the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history).    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jan-2021, the patient experienced INJECTION SITE SWELLING (bump on the injection site). On 12-Jan-2021, the patient experienced RHINORRHOEA (Running nose), SINUS DISORDER (Sinus), INFLUENZA LIKE ILLNESS (Just like flu), FATIGUE (Feeling exhaustion), CHILLS (Chills) and HEADACHE (Headache). On an unknown date, the patient experienced INJECTION SITE PAIN (Injection site pain). At the time of the report, RHINORRHOEA (Running nose), SINUS DISORDER (Sinus), INFLUENZA LIKE ILLNESS (Just like flu), INJECTION SITE SWELLING (bump on the injection site), FATIGUE (Feeling exhaustion), CHILLS (Chills) and HEADACHE (Headache) had not resolved and INJECTION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No concomitant medications reported by investigator o No treatment medications provided by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (pain in arms, legs and hips), exercise tolerance decreased (usually walks about 4 miles but was only able to walk 2 blocks after received the vaccine) and arthralgia, (pain in arms, legs and hips) in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. On an unknown date, patient experienced pain in extremity (pain in arms, legs and hips), exercise tolerance decreased (usually walks about 4 miles but was only able to walk 2 blocks after received the vaccine) and arthralgia (pain in arms, legs and hips). At the time of the report, pain in extremity (pain in arms, legs and hips), exercise tolerance decreased (usually walks about 4 miles but was only able to walk 2 blocks after the vaccination) and arthralgia (pain in arms, legs and hips) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medications or treatment information provided.
Began to not feel well w/ malaise.  Macular rash developed on 1/1 on chest and spread to face, neck, extremities, fever of 102.4 developed on 1/2/11.  Lab work done on 1/5/11 showed thrombocytopenia and low WBC count.
Fever with 101.9 axillary temperature. Took 1g of Acetaminophen and 200mg Ibuprofen. Resolved within 8 hours.
27 years old patient was inadvertently administered one dose of PROQUAD; No additional adverse symptoms; This spontaneous report has been received from a medical assistant concerning a 27-year-old patient of unknown gender. The patient's past drug and pertinent medical history,drug reactions or allergies, as well as the concomitant medications, were not provided.   On 20-DEC-2019, the patient was inadvertently vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, (recombinant Human albumin (rHA)) (PROQUAD) 1 dosage form (lot number S000623, expiration date reported as 06-JUL-2020) as prophylaxis ( concentration, frequency of vaccination scheme, route and anatomical location of vaccination were not reported).  No adverse effects were reported for the patient.   The patient's outcome from the reported events was not reported.
Vaccines received Thursday Nov 7th Patient woke Saturday Nov 9th with itching of right arm and an area of redness/warmth size of 50 cent piece Seen in office by PA at 10am and given Benadryl and informed to do warm compress to arm
This is a non-serious spontaneous case (prospective) pregnancy case, initially received from other non-health professional (consumer), concerning a 30-year-old, adult female pregnant patient. The patient had 3 previous pregnancies in which second pregnancy was miscarriage. The patient's relevant maternal medical history included ulcerative colitis (on an unspecified date). The patient had no relevant paternal medical history and the patient did not use any contraceptive method. The patient had no birth defects and congenital anomalies were occurred in previous pregnancies. The concomitant medication used prior and during pregnancy included REMICADE and sulfasalazine for unknown indications. It was reported that patient's husband did not use any medications prior to conception. The patient's last menstrual period date (LMP) was 13-Sep-2018 and estimated delivery date (EDD) was provided (20-Jun-2019). There was no evidence of defect or adverse finding from a prenatal test and no birth defect or congenital anomalies were noted. On 16-Oct-2018, at approximately 04 weeks gestation (first trimester of pregnancy) the pregnant patient was administered FLUCELVAX QIVc [dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 252676 and expiry date: 31-May-2019] (explicitly coded as vaccine exposure during pregnancy). No treatment measures were taken. It was reported that, after vaccine administration, the patient did not experience any adverse event.
redness, pain and swelling at site of injection; pain in left arm; fatigue; muscle pain; generalized aches.  Took 2000 mg of extra strength acetaminophen on day one; 2000 mg on day 2; 2000 mg day 3.
11/06/2023: Patient a 4 year old male received a Pfizer COVID-19 vaccine (COVID-19, mRNA, LNP-S, PF, tris-sucrose, 10 mcg/0.3 mL), site of administration is the deltoid (side unknown). On the opposite arm at the deltoid patient received an Influenza (Seasonal) (Quadrivalent), brand/manufacturer uknown.  11/07/2023: Around 7 pm, patient complained of itching at the injection sites. No apparent rashes or hives were visible at this time, hydrocortisone 1% was applied sites of itching on the back and rib cage area.  Hives appeared in the evening about 9 pm, hives are seen on chest, sides, back, and bilaterally on the hip area, Cereve and hydrocortisone 1% was applied.  11/08/2023: 2 am patient wakes up complaining of itching from hives, gave patient 5 mL children's diphenydramine, applied 1% hydrocortisone cream.
Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients were vaccinated with improperly stored PROQUAD (lot # M018636, expiration date 11-OCT-2017; lot # reported as M022400, expiration date 01-NOV-2017; lot # M018636, expiration date 11-OCT-2017, dose and route were not reported). No adverse symptoms were reported. This is one of several reports received from same reporter. Additional information has been requested.
-swollen right upper thigh -OTC Meds for fever and pain - Recovered 48 hours
Moderna COVID-19 Vaccine EUA Body aches, fatigue: onset ~4 hours after injection administration chills, fever persisted for ~5 hours despite taking acetaminophen at onset of fever, which was approx. 8 hours after injection All symptoms resolved by the next day.
fever of 100.4 started around 02:30PM until 06:00PM on 1/1/20. Chills and headache.
Patient presented to the emergency department on 8/2/21 with complaints of fatigue, weakness fever, and palpitations. He tested positive for COVID via PCR on 8/2/21. He has been admitted to the hospital and is currently on 4L of Oxygen.
facial numbness on right side of face; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 37-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: ER2613; Batch no: not reported) an unspecified route of administration, administered in right arm (shoulder) on 20Mar2021 at 09:30 am (at the age of the 37-year-old) as dose 1, single for COVID-19 immunisation at clinic put on by local Health Department taking for prevention of covid-19. Medical history included previously had COVID-19 from 20Nov2020 to an unknown date and known allergies included drug hypersensitivity to penicillin from an unknown date and unknown if ongoing. No investigation assessment was reported. No family medical history relevant to adverse event. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the vaccination and no adverse events prior to vaccination. No vaccines were administered on same date of the Pfizer suspect. It was reported that, patient wanted to report an adverse side effect for the Pfizer Covid-19 vaccine. On 23Mar2021 around lunch time, 11 or 12 in the afternoon, the patient experienced facial numbness on right side of face. Event facial numbness on right side of face resulted in physician office on 24Mar2021, thinking it was caused by a robust immune response to the vaccine as event was not worsened but persisting. The adverse event did not require a visit to emergency room and was not hospitalized. Therapeutic measures were taken as a result of facial numbness on right side of face with treatment of ibuprofen and his doctor didn't want to prescribe him a steroid because he didn't want to interfere with the efficacy of the vaccine. Investigation Assessment was not reported. The outcome of the event was reported as not recovered.  No follow-up attempts are possible. No further information is expected.
Shingles shots years ago, got 1st covid shot and got shingles again / suspected vaccination failure; Got shingles again; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a 62-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis and COVID-19 VACCINE for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine, the 1st dose of Shingles vaccine and COVID-19 VACCINE. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional case details were reported as follows: The age at vaccination was not reported. The patient got shingles shot years before reporting and told to patient he or she would not ever need them again but did broke out between two shots, but patient have shingles off and on for years. The patient was in hospital with COVID the end of January got shingles in the hospital and patient got first shot and broke out in shingles again. The patient told not to take 2nd shot of COVID. The patient also had shots for shingles, patient do get shingles even after shots but after the COVID was very painful. It was unknown if the reporter considered the vaccination failure and shingles to be related to COVID-19 VACCINE. This case was considered as suspected vaccination failure, as details regarding laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required. This is 1 of 4 linked cases reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR183413:Same reporter US-GLAXOSMITHKLINE-US2021AMR188669:Same reporter. US-GLAXOSMITHKLINE-US2021AMR188679:Same reporter.
Sedation, Myalgia & Arthralgia Narrative:  Other Relevant History:
still got the flu very bad; Initial information received on 13-Dec-2022 regarding an unsolicited valid social media non-serious case received from a consumer/Non-health Care professional   This case involves an unknown age and unknown gender patient who experienced still got the flu very bad after receiving vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a suspect Influenza vaccine(strength, dose, formulation, frequency, lot number and expiry date: not reported) via unknown route in unknown administration site for prophylactic Vaccination.   On an unknown date the patient developed a non-serious event still got the flu very bad (influenza) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported Was the company suspect product inappropriately used as per local authorization? Unknown Is Sanofi authorized to communicate with the patient's / your healthcare provider?   Action taken : Not applicable.  It was not reported if the patient received a corrective treatment for the event (still got the flu very bad).  At time of reporting, the outcome was Unknown for the event still got the flu very bad.
patient who inadvertently received pediatric DTaP vaccine- made by GSK. The patient was supposed to receive Adacel/ no symptoms; Initial information received on 16-Jul-2019 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves a 12 years old patient (gender unknown) who received vaccine pediatric DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID [DTaP] vaccine instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patients past medical history, concomitant medication and family history were not provided.   On 17-Jun-2019, the patient received a 0.5ml dose of suspect DTAP not produced by Sanofi Pasteur lot PT2RK via unknown route in the right deltoid instead of dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE lot number not reported.  It was an actual medication error due to wrong vaccine administered.  It was reported that patient who inadvertently received pediatric DTaP vaccine- made by GSK. The patient was supposed to receive Adacel.  The patient did not experience any adverse reaction after the injection.   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.
ONSET OF COUGH, FELT LIKE " SHE COULDN'T GET AIR TO GO PAST UPPER CHEST" TOOK TYLENOL WITH CODEINE THEN HAD JOINT ACHES, BODY ACHES AND WEAKNESS. SHE SLEPT AND AWAKENED WITH R CALF MUSCLE SPASM.
Info reported by patient. 10/18/10 11pm awoke shaking; took XANAX w/in 5 min, couldn't think, but couldn't speak; (L) sided weakness (tried to talk to dau. on ph; couldn't). Immed. to ER. Unknown meds. given - s/s gone within 6 hrs. In pt till pm 10-19-10.
Fever; vomiting; diarrhea; loss of appetite; This is a spontaneous report from a contactable other HCP (patient). A 66-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EZ3302) via intramuscular route of administration in the left arm on 02Feb2021 at 12:00 AM (at the age of 66-years-old) as single dose for COVID-19 immunisation. Medical history included hypothyroidism and sulfonamide allergy (allergies to sulfa drug). Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medication included amoxicillin trihydrate, clavulanate potassium (AMOXICILLIN + CLAVULANIC ACID) taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK9231) via intramuscular route of administration in the left arm on 12Jan2021 at 08:00 AM (at the age of 66-years-old) as single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 06Feb2021 at 06:30 AM patient expereinced fever, vomiting, diarrhea and loss of appetite for greater than 3days. The patient did not receive any treatment for the events. Outcome of the events were recovering.  No follow-up attempts are possible. No further information was expected.
No additional AEs were reported; a patient received improperly stored vaccine; This spontaneous report was received from a Medical Assistant referring to a 13 month old patient (gender not specified). The patient's concurrent conditions and medical history were not reported. There was no concomitant medication reported.   On 13-DEC-2021, the patient was vaccinated with a dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # U024221; expiration date: 04-OCT-2023) for prophylaxis which was improperly stored. It was mentioned that the temperature was 39.55 degrees Farhenheit for a time frame of 10 hours. There were no previous temperature excursion. No adverse events were reported.
Pt began complaining of dizziness and "feeling funny" within 30 seconds of receiving vaccine; body jerked back and pt appeared to lose consciousness for about 10-20 seconds followed by nausea; pt regained consciousness at this point and still complained mainly of nausea; tried to keep pt calm, fanned pt and attempted to get BP reading without success; 911 was called after pt jerked back at beginning of episode and they took over care.
Site pain, fevor, sweats, chills, serious fatigue, diarrhea: beginning 1a still ongoing (4:30p).
Niece received second vaccine and was sick for two days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Niece received second vaccine and was sick for two days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Heart failure.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ILLNESS (Niece received second vaccine and was sick for two days). At the time of the report, ILLNESS (Niece received second vaccine and was sick for two days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Although a temporal association exist, there is not enough information to adequately assess the causal association between the reported event and mRNA-1273 vaccine administration as the symptoms of the illness is lacking in the case additional information is being requested
Patient had difficulty breathing after recieving vaccine. Nurse took pulse and found fast pulse rate, patient has No history of anxiety but has history of high cholsterol and high BP.  Onsite EMS was called vitals HR 130 BP 180/103. Patient refused to go to the hospital but will see her doctor.