chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Little more like a flu; (Second shot)body ache a little stronger; Tired; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Little more like a flu), PAIN ((Second shot)body ache a little stronger) and FATIGUE (Tired) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced INFLUENZA (Little more like a flu), PAIN ((Second shot)body ache a little stronger) and FATIGUE (Tired). At the time of the report, INFLUENZA (Little more like a flu), PAIN ((Second shot)body ache a little stronger) and FATIGUE (Tired) outcome was unknown.             No relevant concomitant medications were reported. Treatment details was not provided.  Action taken with mRNA-1273 in response to the events was not applicable.   This case was linked to MOD-2021-025543 (Patient Link).
After receiving the shot at 9:00 a.m., at 6:00 p.m. I started to feel very tired and as if I was getting a fever.  By 9:00 p.m. I was shaking from chills (despite being bundled up under a blanket), so I took my temperature -- it was 100.5 degrees orally.  My normal temperature on that thermometer is 97.6 degrees.   That night, I kept waking up every two hours or so and was very uncomfortable.  THe next day I felt very lethargic -- unable to do anything other than make myself something to eat.  I took two naps, one in the morning, and the other in the afternoon (that was about two hours).  I felt slightly better by around 8 p.m.  That night I slept somewhat better and felt myself break into a sweat during the night -- so I guess that is when the fever broke.  The next day (today) my temperature was back to normal and I feel okay.  Throughout the now three days, the arm where I got the shot was painful, but gets less so each day.
Chest pressure, trouble breathing, pulse ox dropped to 93% that night, nauseous next day
Information has been received from a registered nurse, referring to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 12-AUG-2016 and 15-OCT-2016, the patient was vaccinated with the first and second doses (respectively) of GARDASIL 9 lot # L035105 with expiration date on 14-MAY-2017 (administration route and anatomical location were not reported) for prophylaxis. Later, on 25-NOV-2016, the patient was vaccinated with the third dose of GARDASIL 9 lot # M031557 with expiration date on 07-APR-2019 (administration route and anatomical location were not reported) for prophylaxis. The reporting nurse stated that the patient "received the full three dose series of GARDASIL 9 outside of the recommended dosing schedule". No adverse effects reported.
Administrative deviation only; no adverse event resulted from this deviation.This patient received a  mixed series of COVID-19 vaccine (one dose of Moderna and one dose of Pfizer-box #4 reflects the date of the second dose).The decision to administer a mixed series to the patient was due to an " exceptional circumstance "  stemming from the unavailability of the first vaccine product (Moderna) at the time the second dose was due.We understand that although CDC provides considerations for a  mixed series in exceptional circumstances (such as a vaccine shortage, which was the case here), a mixed series is still considered an administration deviation that requires VAERS reporting.Note second vaccination date is listed.
General malaise, low grade fever the night of the 7th, woke up on the 9th and was having trouble breathing and swallowing, she was taken to the ER.
1 of 2 pts (twins) recvd DTP/HBOC/OPV on 23MAR92 & 24MAR devel nausea, vomiting, & fever; Seen in ER on 25MAR & hospitalized; BC neg; pt died w/in 13 hrs of admittance on 25MAR;
Painful arm at onset. Wife called today, 1/5/2022, to report his arm has remained sore and painful. His elbow swollen. He has appointment with a doctor 1/6/2022 to check it out.
Pfizer  0.3 ml given undiluted-Client was observed for 10 minutes in the lobby and she did not have 15 minutes to wait with no adverse reaction. Called again later in the morning, unable to answer but left message. Established contact at 1410 and she is at work with no problem but a little runny nose. Stated ,the next  building  where she worked burned last night and the air has a smoky smell.
MILD MUSCLE SORENESS AT INJECTION SITE, MILD FATIGUE, IMPROVED WITHIN 12 HOURS
Within 5-10" of receiving DTaP/IPV/MMR/Varivax. Child became irritable, itchy and red on face and torso. Noted few small 1/4" raised areas (hives) on leg and torso. Refused BENADRYL. Has mouth tactile and aspiration issue. In next 1/2 hr. progressed to increased hives with O2 93%. Slight wheeze but not breathing difficulties. Improved after dissolving BENADRYL given.
First night: headache, Body/joint aches.   Day 9 Hives & swelling entire body
NECK STIFFNESS, SORE THROAT/DIFFICULTY SWALLOWING WATER, RADIATING CHEST TIGHTNESS AFTER 20-25 MINUTES,
Employee calling to report a reaction after receiving a COVID-19 vaccine.  Vaccine Name -  Pfizer Vaccine Date - ? 08/31/2021  Is this your first or second dose- 1st Date of symptom onset - ? 09/02/2021 Symptoms - ? Fever 101.8 x 2 days, cough, congestion Last day of work and shift - ? 09/07/2021 Home remedies- Tylenol, Ibuprofen, and Mucinex Any improvement- None Recommendation- Advised employee to keep using home remedies until appointment with PCP on 9/9/2021 Employee voiced understanding Employee of information ? Yes  Employee voiced any concerns ? No  Employee?s questions answered to employee?s satisfaction -Yes  Employee Event Number/Safety Scoop Number -  VAERS Number -
Patient approached EMS table,claims of feeling of dizziness,a few minutes after his receiving 1st dose vaccination.Sat the patient at the private area for further assesment.Patient claims,was anxious and did not eat anything in the morning.Just an episode of dizzyness,no other symptoms.was given a bottle of water,vitals was done.Alert and oriented,no pain,no shorness of breath.Oxygen saturation 98%,vitals signs within normal limits,ambulatory.After a few minutes,he felt better no more dizziness.Wants to go home and get some rest.Was not driving has a friend waiting outside.Signed PCR refusal of transportation to the hospital.I did not get what name vaccine he got,but said has to come back again for second dose.
no adverse event; Monovalent dose administered after the BUD to patient; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) in a 26-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 24-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Monovalent dose administered after the BUD to patient).    It was reported that it was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient ID was reported as Unknown.  Concomitant product use was not provided by the reporter.  It was reported that 77 Monovalent doses administered after the BUD to patients 12 and up. Breakdown of doses were as follows- 37 doses from Lot 059H21, 26 doses from Lot 065K21A, and 12 doses from Lot 058A22-2A.  Treatment information was not provided.
ankylosing spondylitis; This case was reported by a pharmacist via call center representative and described the occurrence of ankylosing spondylitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced ankylosing spondylitis (serious criteria GSK medically significant). The patient was treated with adalimumab (Humira). On an unknown date, the outcome of the ankylosing spondylitis was unknown.   It was unknown if the reporter considered the ankylosing spondylitis to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The reporter asked if a patient who was taking Humira for ankylosing spondylitis could receive 2nd dose of Shingrix. was it contraindicated. When asked if patient was already taking this medication before receiving 1st dose of Shingrix HCP stated she was not able to answer that question. The reporter consented to follow up. Only gender from patient was reported as HCP stated she did not have the information right now. No further details reported.
A week after the shot I had swelling , pain and a rash on my arm where I had the shot.
This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: Unknown. The reporter is the patient. A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed., Manufacturer unknown), for covid-19 immunization. The following information was reported: ANTI-NEUTROPHIL CYTOPLASMIC ANTIBODY POSITIVE VASCULITIS (hospitalization, medically significant), outcome "unknown", described as "ANCA associated Vasculitis"; AUTOIMMUNE DISORDER (hospitalization, medically significant), outcome "unknown", described as "autoimmune disease"; HAEMOGLOBIN DECREASED (hospitalization), outcome "unknown", described as "9 blood transfusions as hemoglobin level frequently drops below 7.0". The patient was hospitalized for anti-neutrophil cytoplasmic antibody positive vasculitis, autoimmune disorder, haemoglobin decreased (hospitalization duration: 32 day(s)). The patient underwent the following laboratory tests and procedures: Antineutrophil cytoplasmic antibody: ANCA associated Vasculitis and autoimmune disease, notes: My diagnosis is ANCA associated Vasculitis and autoimmune disease; Haemoglobin: 7.0, notes: frequently drops below 7.0; Transfusion: 9 blood transfusions, notes: I have received 9 blood transfusions as hemoglobin level frequently drops below 7.0. Clinical course: It was reported that patient was in the hospital for 32 days and diagnosis was ANCA associated Vasculitis and autoimmune disease. Patient received 9 blood transfusions as hemoglobin level frequently drops below 7.0. It was also reported that patient was without any health problems until received Pfizer booster. The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
sick; snotty; fever; bad histamine reaction; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 52-year-old female 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 at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness, nasal mucus increased, fever and reaction to preservatives. On an unknown date, the outcome of the sickness, nasal mucus increased, fever and reaction to preservatives were unknown.   It was unknown if the reporter considered the sickness, nasal mucus increased, fever and reaction to preservatives to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. Caller states the first 5 to 7 years she got the flu vaccine, she got sick.   The reporter states it was not until later on that she realized it was probably due to the preservatives in the vaccine.   The reporter states she tries to get the preservative free vaccine now, but if she did have a reaction now it was much milder and shorter in duration.      The reporter was not able to provide specific time or product manufacturer.
Developed large area of redness induration extending 10 centimeter around site of Tetanus.
Patient is fine with no issues at all; Patient was inadvertently and concomitantly administered PROQUAD in combination with the intended subcutaneously administered VARIVAX on 09/09/2021; This spontaneous report was received from a nurse referring to a 14-year-old female patient. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.      On 09-SEP-2021, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX), subcutaneous (dose, lot number and expiration date not reported) and inadvertently was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) (dose, reoute of administration, lot number and expiration date were not provided) both for prophylaxis (accidental overdose). The patient was fine with no issues at all (no adverse event).
This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP7534 and expiration date was not reported), via an unspecified route of administration in right arm on 18Mar2021 at 17:00 (at the age of 56 years) at single dose for COVID-19 immunization at pharmacy or drug store facility. Medical history included arthritis. Concomitant medications included ibuprofen, vitamin D, magnesium and DoTerra Bone Heal from an unknown date for an unknown indication. The patient was not a pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The patient experienced subarachnoid hemorrhage-aneurysm on 20Mar2021 at 08:00. The patient was hospitalized for this event on an unspecified date in 2021 and discharged within 16 days. It was unknown whether the patient received the treatment or not for this event. The outcome was recovering at the reporting time.
FIRST DAY (mon, 4/26)  10 AM - 12 PM adverse event(s):    ? injection site soreness    ? muscle soreness treatment(s):    ? rest  12 PM - 6 PM adverse event(s):    ? injection site soreness    ? muscle soreness    ? tiredness treatment(s):    ? 2 tylenol extra strength caplets    ? rest  6 PM - 12 AM adverse event(s):    ? injection site soreness    ? muscle soreness    ? tiredness    ? felt warm treatment(s):    ? sleep  SECOND DAY (tue, 4/27)  12 AM - 6 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt cold    ? nasal congestion treatment(s):    ? sleep  6 AM - 12 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? nasal congestion    ? slight fever (99.9 ° F) treatment(s):    ? rest    ? vick?s vaporub topical ointment  12 PM - 6 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? rest    ? 2 tylenol extra strength caplets  6 PM - 12 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? sleep  THIRD DAY (wed, 4/28)  12 AM - 6 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? sleep  6 AM - 12 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? rest  12 PM - 6 PM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? rest    ? 2 tylenol extra strength caplets  6 PM - 12 AM adverse event(s):    ? injection site pain    ? muscle pain    ? joint pain    ? tiredness/sluggishness    ? felt warm    ? slight fever treatment(s):    ? sleep  FOURTH DAY (thu, 4/29)  12 AM - 6 AM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness    ? tiredness    ? felt warm    ? slight fever    treatment(s):    ? sleep  6 AM - 12 PM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness    ? tiredness    ? felt warm  treatment(s):    ? rest  12 PM - 6 PM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness    ? tiredness treatment(s):    ? rest    ? 2 tylenol extra strength caplets  6 PM - 12 AM adverse event(s):    ? injection site soreness    ? muscle soreness    ? joint soreness treatment(s):    ? sleep
Second dose they did have headaches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 03Feb2021 (Lot number: EL3246) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing), notes: Caller says this was diagnosed in 1956 or 1957.; "Antacid" (unspecified if ongoing). Concomitant medication(s) included: PEPCID [FAMOTIDINE] taken for hyperchlorhydria. Vaccination history included: Bnt162b2 (Caller says they both got their first doses on 12Jan2021 with LOT: EL3246.), administration date: 12Jan2021, when the patient was 65 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "recovering", described as "Second dose they did have headaches". Therapeutic measures were not taken as a result of headache.  Additional information: Patient had second dose they did have headaches and hers lasted over a month and then began to go away. Patient started taking Pepcid 6 or 7 or 8 years ago. Vaccine was administered at hospital.   No follow-up attempts are possible. No further information is expected.
At 1:30 patient with heart palpitations. Patient verbalized " I feel my heart skipping". Denies chest pain, shortness of breath. Slight dizziness noted. No change in LOC. Denied nausea and vomiting. Patient assisted to gurney in sitting position. Patient was given water and snacks as requested. 1:33pm - vital signs monitored - v/s signs BP - 165/80, pulse - 81, RR - 18 & 02 sat - 99% RA 1:45pm - Patient felt numbness on Left arm, patient refused to have vital signs taken again x3. 911 was called per patients request 1:52pm - paramedics came to evaluate patient & sent to hospital for further evaluation
This spontaneous case, initially received on 21-Nov-2016, was reported by a health professional and concerns a(n) adult unk patient. Weight: not provided; Height: not provided. Concomitant medication: refer to appropriate report section. Administration of company suspect drug(s): The patient received AFLURIA from Oct-2016 to Oct-2016. Dose regimen: 0.5 ml, Site: Deltoid area, Route of administration: Intramuscular. Batch number: WT54707. No additional suspect drugs. Adverse reactions/events and outcomes: On an unknown date, the patient experienced Significant pain that lasted 2 weeks or longer at the injection site (outcome: Not recovered / Not resolved). Follow-up information received 13-Dec-2016: The patient did not receive any other concomitant vaccination on the same arm. The patient was recommended to rest arm and use ice or heat for pain. The patient experienced no other associated symptoms. The outcome was reported as complete recovery. All doses were administered by a RN (registered nurse) or a Certified Medical Assistant who is also a paramedic. Both have been administering flu vaccines for years. A 22 gauge 1 inch or 1.5 needle was used. The RN is certain that the dose was administered correctly in the deltoid muscle of the arm as trained. Case correction 23-Feb-2017: Follow-up information received on 13-Dec-2016 missing the following information: QA investigation results (final assessment): Risk has been excluded. The review and investigation of the manufacturing, dispensing, shipping and product testing of Influenza Vaccine lot: WT54707 found no evidence of a product quality issue to prompt the potential 'vaccine reaction'.
Headache, fever, tired arm hurt lasted 2 days.  Contracted Covid tested postitive 9/17/2021 2
Pt experiencing flu like symptoms with hot/cold, some sweating, nausea and dizziness. Legs hurting.
sore arm, fatigue Narrative:  * Reporting administration error of COVID MODERNA VACCINE EUA * Per nursing CPRS notes 2/25/2021: "Patient called the covid vaccine line and said he got his covid vaccines 7 days apart and he is panicing about what to do. Verfied per notes that first dose was given on Feb 17 and Second dose on Feb 24th per CPRS notes. Asked patient if he was having any major symptoms like chest pain or SOA, patient denies either. Asked patient what side effects he was experiencing and he said just the same ones as his first shot-sore arm, and fatigue. Told patient I was going to ask my nurse manager about next steps since PCP is out today. Verified call back number with patient and told him if he got any major side effects like SOA, chest pain, disoriented to please call 911 and head to the ER. Patient verbalized understanding. Patient is going to stay by phone for call back from RN." Per addendum on this note from PCC nurse 2/25/2021: "spoke to Dr. (pt's pcp not in clinic today) and informed him pt received his 1st covid inj 2/17 and 2nd inj 2/24. Pt reports only sore arm and fatigue at this time. Dr. advised pt to monitor his symptoms and if he has cp, soa, fevers or just doesn't feel well he should go to ED to be evaluated. Informed patient of pcp's isntructions and he gave verbal understanding. Pt asking if getting these injections so close will it decrease his immunity. Advised pt I can not answer that question but will alert PCP. Pt states he will not go to 3/24 covid appt that is still scheduled until PCP tells him what to do. PT will go to ED if having cp, soa, uncontrolled fevers or if he has symptoms he can not tolerate." Appears pt is stable at this time. PCP to follow-up with patient.
Rash on left hand (top), rash on left eye/eye lid , felt hot/ fever on face ears and neck specially. Treatment: intramuscular Benadryl on 01/19/2017 and MethylPREDNISolone tablets (4mg) & Fexofenadine HCL 180mg tablet (allegra allergy) starting 01/20/2017.