chrisvoncsefalvay/vaers-outcomes huggingface dataset:
inappropriate age; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 5-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 237ZH, expiry date 1st April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 24th August 2021, the patient received Boostrix (intramuscular) .5 ml and Boostrix Pre-Filled Syringe Device. On 24th August 2021, unknown after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 reporter was a nurse assistant. The reporter stated that Boostrix was administered to the patient in right deltoid at an inappropriate age, which led to inappropriate age at vaccine administration. The consent had been given to follow-up with HCP (health care professional). The reporter gave her email address and a fax number to the HCP (health care professional) office. The reporter consented to follow up.
Pt recv vax on 12/16/98; 2 -3 hr post vax pt exp fever, tremors; 12/17/98 pt exp 2 seizures (rigidity,limp,decrease responses), fever (102), diarrhea
Very achy /joints are achy/ dull ache; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (Very achy /joints are achy/ dull ache) in a 42-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7144B) for COVID-19 vaccination.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for Flu vaccination.    Patient does not have allergy to medications, food or other products.    On 22-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 23-Sep-2022 at 7:00 AM,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced ARTHRALGIA (Very achy /joints are achy/ dull ache). At the time of the report, ARTHRALGIA (Very achy /joints are achy/ dull ache) had not resolved.            Concomitant product use was not provider by the reporter.  On 08-MAR-2021, patient received First dose 0.5 mL of Moderna COVID-19 Vaccine with batch number 041L20A. On 05-APR-2021, patient received Second dose 0.5mL of Moderna COVID-19 Vaccine with batch number 041L20A. On 18-NOV-2021, patient received Third dose (First booster) dose of Moderna COVID-19 Vaccine with batch number 034F21A.  Patient's symptoms were reported as stable.  No treatment information was reported.   This case was linked to MOD-2022-650279 (Patient Link).
I had a rash on my neck. It began on the back left side (above the injection site) and then moved around to the front of the neck.
ITCHY EYES; EYELIDS SWELLED; HEADACHE; FATIGUE; TEMPERATURES UP TO 99 DEGREES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 17-MAR-2021 for prophylactic vaccination. The batch number was not reported. The unspecified Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 17-MAR-2021, the subject experienced itchy eyes. On 17-MAR-2021, the subject experienced eyelids swelled. On 17-MAR-2021, the subject experienced headache. On 17-MAR-2021, the subject experienced fatigue. On 17-MAR-2021, the subject experienced temperatures up to 99 degrees. On 18-MAR-2021, Laboratory data included: Body temperature (NR: not provided) 99 degrees (units unspecified). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from eyelids swelled, had not recovered from headache, fatigue, and temperatures up to 99 degrees, and the outcome of itchy eyes was not reported. This report was non-serious.
Narrative: Patient and wife contacted telephone triage nurse today  requesting advice. States patient did fine with the first covid vaccine, but after he  got his second covid vaccine on 2/20/2021 he became ill, has not recovered yet.  Patient is c/o nausea/vomiting, "he looks jaundiced" per wife. Some mild SOB, +  epigastric discomfort, chills, increasing weakness. No diarrhea, "some  constipation." + Dark urine. This nurse asked wife to check V/S. [B/P: 116/65,  pulse 75]. Pt still able to getup and walk around to use restroom, etc. - some  lightheadedness with ambulation. No leg swelling. Patient has been vomiting  several times daily since 2/20/2021. Emesis x 4 since last evening. Recommended  local ER. Wife states she will take him to ER now. Please follow up,  thank you.
I passed out 2 days after getting the vaccine. I was standing and talking and passed out.
Development of ear pressure, tintinis, ringing sounds, dizziness  4 days after shot. Been 5 weeks nows no change. ENT specialist  show visually high inflamation in the middle ear  upon examination. Sprays, antibiotics, flushing, steaming and OTC meication had no effect. ENT frustrated with not enough studies as he has more than myslf as a patient experiencing same post vacine issues.
That night I woke up with my legs aching.  It felt like when you have the flu.  My arm was very sore, but the legs were hurting so bad I could not sleep.  I went to work the next day and had to take an advil.  When I can come from work I was so tired and my legs still hurt.  I went to bed at 7pm and sleep until 5:30 the next day.  My arm is a little sore, but my legs are fine.
pt recvd vax & cried contimuously since inject given; Rt upper thigh observed to be red w/ golf ball sized swelling; heat at inject site & apparent tenderness to touch; to er; devel t; leg hurting;
Angioneurotic edema cellulitis approximately 6 cm in diameter. Discharge summary states erythema, dehydration. msv
Mild/moderate headache (resolved within ~48hrs). Soreness at injection site (resolved within ~24hrs)
Significant : beginning the second day. 12/24/2020 swelling,redness,itching and discomfort  has persisted  including today 12/30/2020.Warm to the touch.
really bad headache; chills; dry mouth; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in deltoid left, administration date 29Mar2021 (Lot number: ER8733, Expiration Date: Jul2021) at the age of 52 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "anemic" (ongoing), notes: unsure of when she was diagnosed, probably since birth; "pre-menopausal" (ongoing). There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 29Mar2021, outcome "not recovered", described as "really bad headache"; CHILLS (non-serious) with onset 29Mar2021, outcome "not recovered", described as "chills"; DRY MOUTH (non-serious) with onset 29Mar2021, outcome "not recovered", described as "dry mouth".  Additional information: The patient had no prior vaccinations within 4 weeks. The patient did not receive additional vaccines administered on same date of the Pfizer suspect. The patient had no history of previous immunization with the Pfizer vaccine considered as suspect. The vaccine was also reported as left shoulder as anatomical location. The vaccine was given between 11:30 and 12:00. Clinical course: Patient stated she got her first shot of Pfizer yesterday and now she had a really bad headache. Patient stated all of her symptoms began after her vaccination. Patient stated she also had chills and a dry mouth. The events did not result to emergency room or physician's office visit. The patient did not undergo any relevant tests.   No follow-up attempts are possible. No further information is expected.
Patient had pain at injection site next day and loss of range of motion in arm without pain. Three days later the pectoral muscle was greatly swollen as was the lymph node in the left armpit the size of an egg. Redness in the armpit occurred and continued down the inner bicep to the elbow, no fever was experienced. Six days after vaccination the swelling in lymph node and pectoral muscle subsided but still had pain and loss of range of motion and developed an ear infection.
Patient developed left lower extremity pain and edema 1 week after J&J Covid vaccination. He was on therapeutic Rivaroxaban given a past h/o DVT. He did not miss any doses. He was diagnosed with a left soleall vein DVT on 06.10.2021  and was switched to Lovenox.  He saw me later for follow up in clinic.  He has chronic pain of his left lower extremity now and is  now daignosed with to have Chronic Regional Pain Syndrome type 1 as per pain management.
This is a spontaneous report from a Pfizer-sponsored program, from a contactable nurse who reported similar events for two patients. This is the second of two reports. A 14 year-old male patient on 18Jul2016 at 3:14 pm received intramuscular for immunisation the first dose of TRUMENBA, (lot M74091, Expiry Date 30Jun2017) at 0.5 ml single in the right arm and the third dose of GARDASIL 9, (Merck, lot M004116, Expiry Date 12Oct2017) at 0.5 ml single in the left arm.  The patient had a normal growth and development. No other vaccine was given within four weeks prior. He was generally a well child. Medical history included penicillin allergy, in 2013 fractures of the base of the proximal phalanx 5th digit of right hand, lentiginous compound on the left parietal scalp, shave biopsied on 12Jan2009 with FU in Sep2016 with no new area of concern, benign nevi, rare.  There were no concomitant medications.  The patient previously took for immunisation two doses of human papilloma vaccine, the first dose on 16Nov2015 and the second dose on 25Jan2016. Other past vaccines given for immunisation included Hepatitis B vaccine on 12Dec2001, 13Feb2002 and 23Apr2003, Rotavirus vaccine on an unspecified date, Diphtheria, Tetanus toxoids, Pertussis on 12Dec2001, 13Feb2002, 18Apr2002, 23Apr2003 and 05Sep2007, Haemophilus Influenzae B on 12Dec2001, 13Feb2002 and 23Apr2003, Pneumococcal vaccine on 12Dec2001, 13Feb2002 and 18Apr2002, Polio on 12Dec2001, 13Feb2002, 18Jul2002 and 16Aug2006, Measles, Mumps and Rubella vaccine on 23Jan2003, 16Aug2006, Varicella vaccine on 23Oct2002, 30Sep2008, Hepatitis A on 05Nov2010, 14Nov2011, DTAP on 12Dec2012, Meningococcal vaccine on 18Feb2014, Influenza on 13Oct2009, 05Nov2010, 14Nov2011 and 12Dec2012. On 19Jul2016 at 12 am the patient experienced right arm pain at injection site, at 8 am he experienced chills, vomiting, fever, nausea, diarrhoea, he also had body aches and was tired, fatigued, lethargic.  Therapeutic measures were taken as a result of the events and included MOTRIN and BENADRYL. The patient was recovering from body aches, he recovered from the other reported events on 20Jul2016. The reporter considered there was a reasonable possibility that the events were related to suspect vaccines. Follow-up (21Sep2016):  Follow-up attempts are completed.  No further information is expected. Follow-up (04Oct2016): New information reported from a contactable nurse includes: suspect vaccines details (route, anatomical location and time of administration), reaction data (new event body aches was added), details on past vaccines and medical history, causality assessment. Sender's Comments: Linked Report(s): US-PFIZER INC-2016367212 same reporter/ products/events, different patient;2016367240 Legacy paper report number.
Today I felt dragging; running a fever of 100,tonight I have a temp on f 99; chills; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Today I felt dragging), PYREXIA (running a fever of 100,tonight I have a temp on f 99) and CHILLS (chills) 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 24-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Nov-2021, the patient experienced PYREXIA (running a fever of 100,tonight I have a temp on f 99) and CHILLS (chills). On 26-Nov-2021, the patient experienced FEELING ABNORMAL (Today I felt dragging). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) for Fever and Chills, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Today I felt dragging) and CHILLS (chills) outcome was unknown and PYREXIA (running a fever of 100,tonight I have a temp on f 99) was resolving.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication information was not provided by the reporter.
pt recvd vax; devel v & a rash which was not varicella like but was described as hives;
Patient has pain that started after vaccine and is now ongoing. It is in the vaccinated arm and also base of left neck. Describes pain as a burning nerve type pain.  It is improving with time but not with gabapentin or tylenol.  Hx of CRPS
the blood pressure went up to 220/110; the blood pressure was going up and down; This is a spontaneous report from a contactable consumer, the patient. This 74-year-old (non-pregnant) female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8734) via an unspecified route of administration in right arm on 01Apr2021 12:30 (at the age of 74-year-old) as single dose for COVID-19 immunization. There was no relevant medical history was reported. The patient did not have any allergies to medications, food, or other products. Concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any medications within 2 weeks of vaccination. On 01Apr2021 around 20:00, the patient's blood pressure went up to 220/110. Since then the blood pressure was going up and down, she had been to an emergency room (ER) 3 times and was hospitalized for one day. Her doctor prescribed 3 blood pressure medications, but the blood pressure is still not under control. The patient stated that she never had these issues before. On 08Apr2021, post vaccination SARS-CoV-2 test via Nasal Swab was negative. This upcoming Saturday (24Apr2021) is supposed to be her second vaccine, but with this blood pressure she cannot take it and her doctor recommends delaying it. The clinical outcomes of the "blood pressure went up to 220/110" and "the blood pressure was going up and down" were not resolved.
Rash and itching at site that spread to neck, face and chest. Took BENADRYL and symptoms resolved within 2 1/2 hours.
Patient developed soreness, tenderness, redness and inflammation (about the size of a ping pong ball) at injection site. The patient reported this to us on the 20th and most of the redness and swelling had gone down but it was still present.
Has hives.  Rash began yesterday (10/23/08) approximately 8 PM ie approximately 7 hrs after flu vaccine given.  Has normal gross vital signs and upper - lower respiratory tract exam.  Begun on Benadryl 250 PO this AM (10/24/08).
My 16 month old baby was given three doses of the Gardasil/HPV Vaccine when she was suppose to get her 15 month vaccines, the doctor said this was given to her by accident as this vaccine was suppose to be given to another child in another room. He advised that I had nothing to worry about. The vaccine was given on her thigh 2 on the right leg and 1 on the left leg.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Nurse).  A 54-year-old male patient received BNT162b2 (BNT162B2), on 19Apr2022 as dose 4 (booster), single (Lot number: FK98494) at the age of 54 years for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 26Mar2021 as dose 1, single (Lot number: 038A21A), on 23Apr2021 as dose 2, single (Lot number: 048B21A) and on 01Nov2021 as dose 3 (booster), single (Lot number: 039021A) for covid-19 immunisation. The patient's relevant medical history included: "HTN" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "obesity" (unspecified if ongoing); "former smoker" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN.  The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Apr2022, outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: He continued to test positive another week; (08May2022) Positive, notes: he tested strong positive for COVID. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: other medication in 2weeks product includes Atorvastatin. The patient did not have any known allergies. The patient received Paxlovid (Ora) from 29Apr2022 to 03May2022, for the treatment of COVID-19; Sender's Comments: Based on the information provided, known drug safety profile and plausible temporal association, the causality between BNT162B2 and Drug ineffective, Covid 19 cannot be completely excluded.
Feels weak with no energy; Chills; Fever; Did not feel well; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Did not feel well), ASTHENIA (Feels weak with no energy), CHILLS (Chills) and PYREXIA (Fever) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Localised infection. Concurrent medical conditions included Diabetes, Cholesterol, Depression and Heart rate. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), METFORMIN, GABAPENTIN, BENZONATATE and VITAMIN B12 NOS for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced MALAISE (Did not feel well), CHILLS (Chills) and PYREXIA (Fever). On 24-Feb-2021, the patient experienced ASTHENIA (Feels weak with no energy). On 24-Feb-2021, CHILLS (Chills) had resolved. At the time of the report, MALAISE (Did not feel well) and ASTHENIA (Feels weak with no energy) outcome was unknown and PYREXIA (Fever) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included glucose pills, cholesterol medications, blood thinner, heart rate pills, depression medication and antibiotics for toe infection. Treatment medications included acetaminophen and ice bath.
Unusual Menstrual cycles since vaccination. My cycles have been longer and much heavier since vaccine., but after 6-7 months seems to getting close to normal. Also I experienced spotting between periods for the 4  months after (which has never happened in my life).   This seems to be resolved now.
I felt nauseous then I started to violently vomit and have diarrhea all day and night, the next day I had a migraine and felt ?out of it?, and had no energy
My arm was sore right away after shot and then it went away and then at times I would notice it didn't feel right at times. After the 2nd dose, I did have the pain and swelling in my arm and that lasted a while, but it was nothing that bothered me that much and I didn't know if I had done something to my arm. It was just an annoyance.
Information has been received from a registered nurse (R.N.), concerning an unspecified number of patients of unknown ages and genders. The patients' pertinent medical history and concurrent conditions were not informed. It was reported that on unspecified dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX, lot # M010472, expiration date 01-JUN-2017, (dosage and therapy route were not provided). No adverse effects were reported. Concomitant therapies were not informed. No product quality complaint (PQC) was involved. This is one of the several report of the same source. Additional information has been requested.
woke up in a puddle of sweat; dizziness; weakness; Fever; nausea; vomiting; fatigue; less than 25 days for administration of the second dose; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), ASTHENIA (weakness), HYPERHIDROSIS (woke up in a puddle of sweat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 25 days for administration of the second dose) and PYREXIA (Fever) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A and 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concomitant products included METOPROLOL, ISOSORBIDE, LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN 1000) and ATORVASTATIN for an unknown indication.   On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 25 days for administration of the second dose). On 06-Sep-2021, the patient experienced DIZZINESS (dizziness), ASTHENIA (weakness), PYREXIA (Fever), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue). On an unknown date, the patient experienced HYPERHIDROSIS (woke up in a puddle of sweat). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 06-Sep-2021, PYREXIA (Fever) had resolved. At the time of the report, DIZZINESS (dizziness), ASTHENIA (weakness), HYPERHIDROSIS (woke up in a puddle of sweat), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (less than 25 days for administration of the second dose), NAUSEA (nausea), VOMITING (vomiting) and FATIGUE (fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Sep-2021, Pyrexia: high (High) High (fever of 102 F).         Patient also take Water pill as a concomitant medication.
trying to get my strength back; sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness and strength loss of. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the strength loss of was not recovered/not resolved.   It was unknown if the reporter considered the sickness and strength loss of to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated to be careful with the flu shot. The patient was so sick for 3 days and was just trying to get the strength back. This was the first time that had ever happened to the patient.