chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Fatgued; Joint pain; Fever over 100 °F; Severe body ache/ severe pain; Felt very sick/ feels really bad; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt very sick/ feels really bad), FATIGUE (Fatgued), ARTHRALGIA (Joint pain), PYREXIA (Fever over 100 °F) and MYALGIA (Severe body ache/ severe pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Apr-2021, the patient experienced MALAISE (Felt very sick/ feels really bad), ARTHRALGIA (Joint pain), PYREXIA (Fever over 100 °F) and MYALGIA (Severe body ache/ severe pain). On 19-Apr-2021, the patient experienced FATIGUE (Fatgued). At the time of the report, MALAISE (Felt very sick/ feels really bad), FATIGUE (Fatgued), ARTHRALGIA (Joint pain), PYREXIA (Fever over 100 °F) and MYALGIA (Severe body ache/ severe pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Body temperature: over 100 ° (High) over 100 °F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Patient on 16-Apr-2021 felt a little better and felt better even on 19-Apr-2021. Treatment information was not provided.   This case was linked to MOD-2021-150415 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 19-May-2021: Follow up was received on 19 may 2021 included  no new information about first dose.
Patient woke describing what she thought was a seizure .  She was shaking uncontrollably  and felt like she could not speak or wake her husband.  She also said she could not stand.  She did not lose consciousness though.  She also said she now felt fine when telling me about it the next day.  She did not seek medical attention but I did tell her to discuss with her PCP
No adverse event; Patient was administered an expired MMR II vaccine; This spontaneous report was received from an Office administrator via company representative regarding a 01-year-old female patient. The patient's medical history and concurrent conditions were not reported. Concomitant therapies included sterile diluent. On 21-JAN-2020, the patient was vaccinated with an expired measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live recombinant human albumin (rHA) (M-M-R II) with a lot # R000555 and expiry date was reported as 08-JAN-2020 (expired product administered) (strength, dose and route were not reported) for prophylaxis. No additional adverse events were reported.
in error patient received a flu vaccine which was not made especially for people over 65 years of age/no AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-health care professional (patient).  This case involves male patient (age unspecified) who received an INFLUENZA VACCINE [FLU VACCINE] [lot number and expiry date not reported] in error which was not made especially for people over 65 years of age via an unknown route at an unknown administration site, on an unknown date for prophylactic vaccination (product administered to patient of inappropriate age).  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  It was a case of actual mediation error due to inappropriate age at vaccine administration.  It was reported that, patient did not known name of flu vaccine.   At the time of report, no adverse event was 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.  There will be no information available on the batch number for this case.
Itchy at the injection site. Onset of symptom under 1 hour. All other vital signs normal. No need for additional care or treatment.
Started out with fever/chills, body aches, lack of energy. Transitioned to nausea on Sunday and diarrhea Monday morning.  I have now had diarrhea 3 days straight and nothing will stop it.
This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. On 13-AUG-2013 the patient was vaccinated with VARIVAX (Merck) (lot# unspecified). The patient was stung by a bee on an unspecified date in August 2013. The patient was treated with epinephrine at an unspecified urgent care facility for an unspecified reaction to the bee sting on an unknown date. The outcome of the event was unknown. Additional information has been requested.
Bump and a lot of pain at injection site, lots of sweating, fevers and chills, neck and muscle pain, achy everywhere, extreme exhaustion, dizzy when I stand or sit up.
large round red mark around injection sight. Swollen lymph nodes of armpit on left  arm
Dizziness, Syncope recovered in few minutes. Patient also complained of severe pain at Vaccine site. Tylenol PO given.
Temp - 103 - agitated - jerky reflexes, high pitched scream - unconsolable
Narrative: Per 11/13/2022 ED note "comes emergency department today reporting that she is having allergic reaction to flu shot that she just received. The patient states that she just received the injection and suddenly felt tingling in her left deltoid where she received the injection and then started to have generalized pruritus worse on the left with subsequently spread all over. The patient reports no difficulty breathing no odynophagia no dysphagia. The patient has never had any allergic reaction to the influenza vaccine in the past; she is not allergic to eggs... (Plan - 1) Benadryl 50 mg IV 2) Solu-Medrol Initially 2) Solu-Medrol initially 5mg IV"
Persistent tingling in the feet; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the right arm on 30Mar2021 at 15:00 (at the age of 33-year-old) as a single dose for COVID-19 immunisation. The patient's medical history included sports induced asthma, prostatitis and rhinitis. The patient had no known allergies. Concomitant medications included fexofenadine (MANUFACTURER UNKNOWN), vitamin d nos (MANUFACTURER UNKNOWN) and salbutamol (ALBUTEROL INHALER) from unknown dates and unknown indications. 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 30Mar2021 at 20:00, the patient experienced persistent tingling in the feet front half of the foot, 55 hours post first vaccination and still continued at the time of the report. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether the patient received any treatment for the event. The clinical outcome of the event persistent tingling in the feet was not recovered at the time of the report.  No follow-up attempts are needed. No further information is expected.
My leg started hurting 2 days later and 2 weeks later they found a blood clot in my left leg
This case was reported by a nurse via call center representative and described the occurrence of muscle pain in a 54-year-old female patient who received SHINGRIX for prophylaxis. On 4th September 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 4th September 2018, less than a day after receiving SHINGRIX, the patient experienced muscle pain, headache, injection site pain, influenza-like symptoms, injection site erythema, injection site swelling, fever and chills. On an unknown date, the outcome of the muscle pain, headache, injection site pain, influenza-like symptoms, injection site erythema, injection site swelling, fever and chills were not recovered/not resolved. It was unknown if the reporter considered the muscle pain, headache, injection site pain, influenza-like symptoms, injection site erythema, injection site swelling, fever and chills to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on left deltoid. The patient's body temperature went as high as 102 degrees fahrenheit.
Member reported to the clinic after calling. His bicep was red, swollen, hot, tender, and tight. No fevers, vomiting, GI symptoms. He was brought to the Urgent care center to be seen right away.
pt recv vax & exp rash w/urticaria over entire body;onset 3hr post vax;
First started to do it by numbing her and keeping her awake but her blood pressure went up to high; she states that dose in the syringe was "less than half the syringe full; This is a spontaneous report from a contactable 63-year-old female consumer (patient herself). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration, administered in left arm on 31Mar2021 (age at vaccination: 63) as dose 1, single for Covid-19 immunisation. Patient's medical history included a new Pacemaker put in on 14Apr2021 which was originally attempted to be placed with local anesthesia only, however, due to elevated blood pressure they placed it under light sedation, and ongoing kidney failure which started years ago on an unspecified date. Concomitant medications were none. When patient received her first dose by the Pharmacist, she stated that dose in the syringe was less than half the syringe full and then when she went back to receive the second dose she states that it was given to her by "the clerk" instead of a Pharmacist because the Pharmacist was not available that day. On 14Apr2021, she got new pacemaker put in, was put under anesthesia, and first started to do it by numbing her and keeping her awake but her blood pressure went up to high and so they lightly sedated her. The outcome of the events was unknown.  Additional information has been requested.
2 days after 2nd dose all day moderate headache and nausea,  3 days after 2nd dose woke up at 4am with tingling in lungs and shortness of breath.
Eyelids were swollen; Mild itching near anus; Full body rash and hives; Full body rash and hives; Itching began in armpits; This is a spontaneous report from a contactable consumer or other non-HCP. A 49-years-old female patient received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0151) via an unspecified route of administration in right arm on 05Apr2021 10:45 as dose 2, single (at the age of 49 years-old) for COVID-19 immunization. Patient medical history included blood cholesterol diagnosis, lumpectomy for a non-cancerous papiloma 2014, spinal fusion surgery 2011 and sulfa drugs allergy (drug hypersensitivity). The concomitant medications included montelukast sodium taken as 10mg 1 QD, loratadine taken as 10mg 1 QD, fluticasone propionate taken as 1 spray per nostril QD, atorvastatin taken as 10mg 1 QD all for an unspecified indication, start and stop date were not reported. The patient was not a pregnant at the time of vaccination. Historical vaccine included BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EN6208) via an unspecified route of administration in right arm on 14Mar2021 02:45 PM as dose 1, single for COVID-19 immunization. Vaccination facility type reported as Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the was not patient diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19. The patient experienced on 14Apr2021 morning itching began in armpits, full body rash and hives, the evening mild itching near anus that lasted a few days, and eyelids were swollen on 15Apr2021. Patient took three 12.5 mg Benadryl dose tablets and by morning of April 15 rash had spread to neck and eyelids were swollen. Took 2 more 12.5 mg Benadryl. Then patient went to Urgent Care facility to seek more medical attention. Therapeutic measures were taken as prescription issued for 6-day treatment course of 4mg methyl prednisone dose pack a result of eyelids was swollen (swelling of eyelid), mild itching near anus (anal pruritus), full body rash and hives (rash), full body rash and hives (urticaria), itching began in armpits (pruritus). The outcome of all events was recovering.  No follow-up attempts are needed. No further information is expected.
-> Redness & swelling at the site of injection. -> Fever. -> Body aches. -> Lump at the site of injection.
83 y.o female presents to the ED with /co cough. Pt states she was seen by her PCP last week and given a prednisone taper for COPD exacerbation. She states her symptoms have never improved, and in fact, have worsened. She wears 2 L NC at home. She has not been febrile.
Vomiting; Body temperature low (95.5 degrees F); Low body temperature after vomiting (95.5 degrees F) with excessive sweating; Body aches; Chills; Headache; Nausea; Fever of 100.4; This is a spontaneous report from a contactable consumer, the patient. A 28-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the left arm on 08Apr2021 at 10:15(at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, migraine, GERD (gastroesophageal reflux disease), mitral valve prolapse and penicillin allergy. Concomitant medications included escitalopram oxalate (LEXAPRO) and sumatriptan succinate (IMITREX) and multivitamin (MANUFACTURER UNKNOWN) all for unknown indications, from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) via an unspecified route of administration as a single dose for COVID-19 immunisation. 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 COVID vaccine. On 08Apr2021 at 11:45 the patient experienced vomiting, low body temperature after (95.5 degrees F), excessive sweating, body aches, chills, headache, nausea and fever of 100.4. The patient did not receive any treatment for the event. The patient underwent lab tests and procedures, which included body temperature on 08Apr2021 and the result was 95.5 degrees F and body temperature with the result was fever of 100.4. No therapeutic measures were taken as a result of reported event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events vomiting, low body temperature (95.5 degrees F), excessive sweating, body aches, chills, headache, nausea and fever of 100.4 were resolving at the time of report.  No follow-up attempts are needed. No further information is expected.
pt stated after receiving the shingrix vaccine both shot 1 and shot 2 he got contact dermatitis and another skin affliction requiring him to visit his dermatologist. He noticed this after both shingrix shots.
Redness and Localized Pain @ vaccination site.  Patient stable and released from vaccination site.
Patient is a 45 year old male A & O x4 complaining of anxiety approximately 5 minutes after receiving the injection.  Patient stated that he became very anxious with slight blurred vision.  Patient stated that he has had similar events in the past when he is in a medical environment.  Patient was placed in a sitting position in the medical evaluation area with vital signs obtained.  Initial blood pressure was low but improved to normal limits quickly once in the sitting position and patient stated that his symptoms completely resolved.  Patient has a history of anxiety, and allergy to an unknown antibiotic and takes no medications. Negative chest pain, shortness of breath, weakness, dizziness, blurred vision, anxiety and there were no signs of allergic reaction or stroke.  Patient was able to stand with no symptoms and continued to deny any complaint.  Patient denied any further care and stated that his wife would drive him home.  Patient was advised of risks, consequences and when to seek medical care.  Patient was accompanied to his vehicle by (EMT) and left with his wife via private vehicle.
1600 hrs. Stated throat burning and felt like it was closing up, hot flashes, ears ringing, and warm.  Vitals monitored every 15 minutes with first set being within range with the exception of elevated BP at 150/90.  Benadryl 25 mg given PO.  Sitting in chair, able to answer all questions with no apparent distress in speaking.  Continued symptoms above at 1630 administered an additional 25mg benadryl PO .  Alert and oriented, able to call spouse for a ride home.  Due to continued symptoms rapid response team was called for evaluation and took over care to be transferred to ER for further monitoring and evaluation.
5/26/23  Ischemic Stroke with Aphasia - no cause determined; intermittent severe pain (and occasional numbness) in the upper left quadrant of back, upper left arm, neck and  head Symptoms:  confusion; aphasia; inability to read & comprehend Hospitalization:  5/26/23-5/31/23
Two RNs reviewed registry's IZ routing slip for doses due. Both failed to notice that patient had already received a dose of seasonal influenza vaccine for the 2016-17 season and that the due date shown on the routing slip for the next dose of seasonal influenza vaccine was later in 2017 (well after the vaccine administration date). The new Immunization Registry does not visually distinguish between doses currently due and those due in the future, contributing to this error.
Breakthrough case admission after 3 vaccines  Pfizer 1/22/21 lot# EL9261;  Pfizer 2/12/21 lot# EL9269;  Pfizer 10/9/21 lot# 30125BA
other zoster-related conditions; shingles; This spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 76-year-old patient (pt) of unknown gender. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or about 08-AUG-2019, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (exact dose, site and route of administration, lot# and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the pt was treated for the following injuries resulting from the pt's zoster vaccine live (ZOSTAVAX) use: shingles and other zoster-related conditions. The outcome of the events was not provided. The relatedness between the events and zoster vaccine live (ZOSTAVAX) was related.
Right arm-deltoid-red and swollen, tender to touch 2-3 inches in size at injection site, painful.  Per Dr., DTaP reaction with cellulitis.  Was put on Cefzil 250mg.
itchiness at injection site; rash at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchiness at injection site) and VACCINATION SITE RASH (rash at injection site) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No medical history was reported by the reporter.  Concomitant products included GABAPENTIN, ZOLPIDEM TARTRATE (AMBIEN), VITAMINS NOS and 12 VITAMINS FOR INJECTION for an unknown indication.    On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (itchiness at injection site) and VACCINATION SITE RASH (rash at injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form and HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency. On 30-Jan-2021, VACCINATION SITE PRURITUS (itchiness at injection site) and VACCINATION SITE RASH (rash at injection site) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
Mass vaccine clinic.  Both Moderna and Pfizer being offered. Nurse gave Moderna instead of Pfizer.  Administration error
Redness, swelling, warmth to injection site occurring on 7/26/18 (Left shoulder). 7-30-18 Spoke with client - better but still some soreness swelling and little warmth.
No additional AEs were reported; The physician reported that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQUAD (w012743  10/16/2023) Temperature: 10.1F  Time frame:; This spontaneous report was received from physician and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-OCT-2022, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) recombinant human albumin (rHA), subcutaneous injection, lot #w012743, expiration date: 16-OCT-2023, administered for prophylaxis (dose, strength, and route of administration were not provided) (product storage error).  Administered dose of vaccine experienced the temperature excursion of 10.1 degrees Fahrenheit (F) for 51 hours. There was no previous temperature excursion.   There was no adverse event reported.
An hour and a half  I became dizzy.  Within two hours nausea and diarrhea.  For 24 hours could not eat it drink without being sick. Then numbness and tingling in arms and legs. Day two face was numb. nurse saw twitching eyes ,hands and I had it all over.  Chest pains when I got up.  During the night of day 2 I woke with my entire body trembling. My face was swollen the entire day. Today is day 3. My lips twitch occasionally, my face has an occasional tingle, still have diarrhea and nauseous, I am trying fluids and and I just tried an egg.  I feel like I have worms crawling inside my arms and legs.  I was told by the pharmacy and school nurse that it would take 3-4 days to feel better.  I am healthy and a teacher.  This is very concerning.
Patient called and said he got very sick from the vaccine. Said he got some hives a few days after the vaccine was administered. Said high fever, very tired flu like symptoms.
Delirium, confusion, anxiety, and depression Nausea, no appetite headache, body aches pale, flushed cheeks Low blood pressure
Starting the day after getting the vaccination the patient complained of red, itch rash (size of 4 in circle) around the area of the injection site. Patient said it was swollen and hot to the touch.
Low platelets, thrombocytopenia, bleeding from mouth, large bruising, purpura, petechiae, rash of pinpoint-sized reddish-purple spots on lower legs. Treated with at least 2x2 units of platelets, IVIG for several days (at least), diagnosed as ITP, immune thrombocytopenia. Developed aspirational pneumonia in hospital. Admitted with platelets at 1x10^9/L; discharged on day 5 with 79x10^9/L.  Patient had ITP 10 years earlier and was recovered from it.