chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Vomiting; Swelling at the injection site; Nausea; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included FLUOXETINE for an unknown indication.    On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness at injection site). On 02-Mar-2021 at 11:00 PM, the patient experienced NAUSEA (Nausea). On 03-Mar-2021, the patient experienced VOMITING (Vomiting). 03-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Swelling at the injection site). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE SWELLING (Swelling at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
nausea, diarrhea, fever, severe stomach cramping that lasted a 8 days, 3 weeks later had tingling neuropathy return to my legs, fatigue
Patient states he awoke the morning after the shot with decreased appetite, weakness, lassitude, muscle aches and a feeling of "cloudy headed."  His symptoms have slowly subsided over the course of the day except for the "cloudy headed" feeling, which he stated was still slightly present.  He was advised to take acetominophen for symptoms, but it is unknown if he did.
Vaccines that were administered beyond use date after thaw process; This spontaneous case was reported by a paramedic and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines that were administered beyond use date after thaw process) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient's age was reported as 71 years 1 months.  It was unknown if patient have any allergies to medications, food and other products. It was unknown if patient had ever been diagnosed with/ tested positive for COVID-19. It was unknown if patient have any acute illnesses at the time of vaccination and up to one month before. It was unknown if patient have any chronic or long-standing health conditions.  No concomitant medication was reported.  There was no patient that had any adverse reactions and no reports of any reactions after the administration of the vaccines.   No treatment information was provided.
No adverse effects were reported.; the patient was administered an improperly stored dose of VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, past medical history, concomitant medications and drug reactions or allergies was provided.  On 07-OCT-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # S002874, expiration date 29-JAN-2021 (dose and route of administration were not reported) for prophylaxis. The sterile diluent (lot # N030413, expiration date 05-JUL-2020) used to reconstitute varicella virus vaccine live (oka/merck)(VARIVAX) was properly stored. No adverse effects were reported. Administered dose of vaccine experienced the temperature excursion of 7.64 degrees Fahrenheit for 20 minutes. Data logger was involved. There was previous temperature excursion of 19.34 degrees Fahrenheit for 34 minutes.
p/inj crying alot-became pale, roll over the eyeball; p/stimulation by mom start crying again & acted very irritable; then calm down x 5 mins period;
From initial information received on 5/6/03 from a healthcare professional regarding an adverse event occurring in the USA, it was reported that a 51 year old male patient received IMOVAX RABIES, lot number U1388, administered in the left deltoid on 4/29/03. Four days later, the patient developed headache, fever, and left arm pain which was described as severe aching. The patient was not evaluated by a physician and it was reported that the events subsided without medical treatment. At the time of vaccination, the patient was experiencing jet lag and was also taking doxycycline for anti-malarial prophylaxis. The patient recovered from these events.
Within First 15 minutes neck and shoulder pain on side of injection site  Injection site soreness in right arm and shoulder  Nausea  Headache  Aggression/frustration
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 64-year-old male patient received BNT162b2 (BNT162B2), on 16Feb2021 as dose 1, single (Lot number: EN6200), in right arm, on 08Mar2021 as dose 2, single (Lot number: EN6205), in left arm and on 21Dec2021 as dose 3 (booster), single (Lot number: 33025BD) at the age of 64 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Yes, sulfa based antibiotics give me a rash" (unspecified if ongoing); "known allergies: Yes, sulfa based antibiotics give me a rash" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Unknown Result. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had not other medication in 2 weeks. The patient had received covid 19 treatment, paxlovid, from 01Jun2022 (Lot number: FY4445) to 04Jun2022 for COVID-19 treatment.   No follow-up attempts are possible. No further information is expected.
This spontaneous report was received from a registered nurse concerning an unspecified number of patients with unknown demographics. On an unknown dates, the patients were vaccinated with an imporperly stored doses of GARDASIL 9 lot # M032650, expiration date 31-MAR-2019 for prophylaxis (route, dosage and anatomical location were not reported). The storage conditions were reported as follows: temperature 50° F, time frame 2 hours, with no previous temperature excursion. A data logger issue was involved. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA002261.
THE DAY AFTER PT RECEIVED ZOSTER VACCINATION (SAT JUN 12) PT EXPERIENCED REDNESS AND SORENESS AT THE INJECTION SITE (POSTERIOR LEFT ARM).  BY EVENING THE AREA WAS SWOLLEN.  SUN JUN 13 AM THE SWOLLEN AREA HAD EXTENDED AND PT WAS TAKEN TO THE ER.  PT RECEIVED 2 IM ANTIBIOTIC INJECTIONS WITH DIAGNOSIS OF "INFECTION".  PT WAS SENT HOME AND TOLD TO RETURN IMMEDIATELY IF THE SWELLING GOT BIGGER.  MON JUN 14 AM THE AREA OF SWELLING WAS SPREADING DISTAL TO LEFT ELBOW.  PT WAS TAKEN TO THE ER AND WAS ADMITTED TO THE HOSPITAL.  PT RECEIVED IV ANTIBIOTICS EVERY 6 HOURS AND WAS DISCHARGED TUES JUN 15 IN THE AFTERNOON.  PT IS TAKING ORAL ANTIBIOTICS EVERY 6 HOURS AND INJECTION SITE IS REPORTED TO NOW BE ABOUT 2 INCHES IN DIAMETER AND PT IS FEELING MUCH BETTER.
Administration of expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administration of expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   no concomitant medications were reported. no treatment medications were reported Vaccine was administered on 09Sep2021 patient's second dose. HCP said patient was not experiencing any symptoms, patient left fine with no issues.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Non sig fup: We have already completed a VAERS report for this incident. The temporary number is 640223.
Within two days, I had extreme lower back pain, stomach pain, mucous and diarrhea to date. Feb 15, 2022, back pain and sciatica persist despite treatment. Diarrhea resolved within about 2-3 weeks.
Time noted above is when patient arrived home from school, actual time of onset is unknown from him being at school but according to patient symptoms started aprox two hours before arriving home.  hoarseness, red raw throat, congestion, runny nose, irregular heartbeat and breathing, difficulty sleeping, puffy face.  I had patient go to school nurse next morning to report symptoms and check for any serious issues, nurse noted no fever (as I did as well); said he did appear to have red swollen nodes and hoarseness as well as runny nose but nothing to worry over.  Symptoms persisted for 5 days maxing out at day 2 and day 3.  Gave Mucinex for noted congestion, and Motrin for ache's and to ensure no onset of fever.  Patient took cough drops to aid in sore throat.
Patient was given the MMR on Monday.  Tuesday night he had seizure like symptoms including, stiffness of the body, arched back, jerking of the arms and legs, unresponsiveness and stuttered crying.  This episode lasted about 30 mins.  He was seen by Dr. at who said that he didn't need any further extensive testing or treatment because he is so young and the episode didn't seem to interfere with his breathing or do anything dangerous to him.
less than 10 mIU/mL for patient who completed series; This non-serious case was reported by a nurse via other manufacturer and described the occurrence of therapeutic response decreased in a patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Co-suspect products included DTPa-HBV-IPV (Pediarix) for prophylaxis and DTPa-HBV-IPV (Pediarix) for prophylaxis.   On 03-NOV-2005, the patient received the 3rd dose of Pediarix .5 ml. On an unknown date, the patient received the 2nd dose of Pediarix .5 ml and the 1st dose of Pediarix. On an unknown date, an unknown time after receiving Pediarix, Pediarix and Pediarix, the patient experienced therapeutic response decreased (Verbatim: less than 10 mIU/mL for patient who completed series). The outcome of the therapeutic response decreased 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 Information: GSK Receipt Date: 19-APR-2023 The reporter called to request information for revaccination of Hepatitis B after post-vaccination test showed anti-HBs antibody concentrations less than 10 mIU/mL for patient who completed Pediarix series.  No further information provided, no additional adverse events, no PQC (product quality complaint). The reporter called to request information for revaccination of Hepatitis B after post-vaccination test showed anti-HBs antibody concentrations less than 10 mIU/mL for patient who completed Pediarix series, which led to therapeutic response decreased.
My left arm had a big red welt where the shot has been administered.  It was about 4 inches long and 3 inches wide.  This area was very itchy and it lasted about 3 days to completely go away.
Patient received two doses of Sinovac in a certain country,  his last dose was in September 2021. Patient received Pfizer as a booster on 1/22/2022.  The booster was suppose to be given 5 months after last dose.  The patient did not experience  any adverse reactions after receiving the vaccine.
Pt called to report yesterday received the FLUZONE vaccine at 3:30PM. She states at 7PM yesterday she felt throat closing up, was coughing and had some wheezing. States took Benadryl 50mg by mouth at 7:30PM and Albuterol Inhaler 2 puffs at 7:45PM. -No other medication taken. Next day (today) has a little sore throat and HA. She did not seek medical.
Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Additional Details: patient complained of redness, some swelling, and itchyness,and a rash at the site of injection and that was on the chest as well that lasted about 14 days and she treated it with hydrocortisone cream
"Horrific pain" immediately after injection, did not resolve for 6 weeks, hot flashes that have not resolved
The patient developed a red, painful rash that started to enlarge throughout the day about 20-24 hours after vaccine administration.  It continues to be red and painful now (about 43 hours after vaccine).  She has used ice for the swelling without much help.  She was advised to take Benadryl for the rash and Aleve for the pain.
Painful left shoulder joint becoming more painful with limited range of motion on 09/25/2015.  Limited motion in left shoulder with pain continues today, though I have begun doing PT exercises at home.
INR increased from the therapeutic range (2-3) to 5.2; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received the 1st dose of bnt162b2 (COMIRNATY), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included pulmonary embolism from an unknown date and unknown if ongoing recurrent. Concomitant medication included warfarin (WARFARIN) taken for pulmonary embolism (recurrent), start and stop date were not reported.  The patient experienced INR increased from the therapeutic range (2-3) to 5.2 (medically significant) on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included international normalised ratio: from the therapeutic range (2-3) to 5.2 on unknown date, platelet count: well within the normal range on unknown date. The patient reported bleeding more easily with blood draws and finger sticks than previous.   The lot number for bnt162b2 was not provided and will be requested during follow-up.; Sender's Comments: Limited information precludes a comprehenisve causality of event INR increased with BNT162b2 .Concomitant medication warfarin can be significant risk factor.
Pericarditis; This is a spontaneous report received from a contactable consumer. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot number and expiration date was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced pericarditis on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
03/27/2023, I noticed my stomach was queasy, I had headache, general body aches. The next morning my body aches were really bad. I decided to use one of my COVID-19 home test and the results were positive. 03/28/2023 I had a telehealth visit with a clinic. We went over my symptoms and because I was COVID-19 positive. They prescribed Paxlovid. My symptoms gradually got better. My symptoms lasted for about 10 days. As of today, 05/02/2023, I still have a pretty extreme fatigue.
headache about 12 hours after receiving COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 5-year-old female patient received BNT162b2 (COMIRNATY), 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: HEADACHE (non-serious), outcome "unknown", described as "headache about 12 hours after receiving COVID vaccine". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Initial report received on 20 April 2011 from a consumer, who is the patient. A 55 year old female patient, with an allergy to thimerosal, received a left deltoid intramuscular injection of ADACEL (lot number unknown) on 10 January 2011. The patient had no illness at the time of vaccination. Concomitant medication included Levothyroid. She had received previous tetanus vaccines. On the night of vaccination (10 January 2011), the patient experienced fatigue. One week later, she had a rapid heart beat. One week after that, she had "an electric sensation in her head which transformed into migraine headaches". She continued to have these headaches, balance problems, cognitive problems, and double vision at times. On an unspecified date, the patient consulted a physician. Diagnostic tests included MRIs, CAT Scans, labs, and other tests that showed nothing. At the time of the report, the patient had not recovered.
He had fever the next day, and also developed a generalized erythematous maculopapular rash involving, trunk, extremities and face 3 days after the first dose of COVCID-19 vaccine
Cellulitis left arm. Treated with Cephalexin 1000mg PO BID x 10 days.
took 1 capsule & devel stomach cramps & had diarrhea for about 3 hrs;
Expired vaccine used; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  No treatment information was provided.
About 12 hours after the shot I developed muscle aches, chills and sweats.  The following day 10/24 I still had muscle aches and chills.  This morning on 10/25 I developed a rash on my torso running across my body under my bra line.  Rash isn't itchy, warm or painful.  I developed these same exact symptoms with my 2nd dose of the Pfizer vaccine which I had on 3/24/21 lot#EN6199.  I believe my healthcare provider reported that one, but not sure.
Case number PHEH2011US55982 is in initial spontaneous report received from a nurse on 20 Jun 2011 with a follow up from nurse received on 14 Jul 2011. This report refers to a 14 year old male patient. He was vaccinated with MENVEO (batch number: X100028) 0.5 ml, intramuscularly on 15 Jun 2011. The patient received only the Men CYW-135 liquid component without reconstituting it with Men A powder component. No adverse event was reported following this drug administration error. Follow up information on 14 Jul 2011: The patient demographics and vaccination details were updated.
This case was reported by a nurse via call center representative and described the occurrence of fever in a 52-year-old female patient who received FLUARIX QUADRIVALENT  (batch number 579KX, expiry date 30th June 2017). Concomitant products included Ropinirole, CELEXA and ELIQUIS. On 26th October 2016 the patient received FLUARIX QUADRIVALENT. In October 2016, 12 hrs after receiving FLUARIX QUADRIVALENT, the patient experienced fever, vomiting and chills. On an unknown date, the outcome of the fever, vomiting and chills were not recovered/not resolved. The reporter considered the fever and vomiting to be unrelated to FLUARIX QUADRIVALENT. Additional details were provided as follows: This case was previously reported to a doctor. In the morning of reporting date, the patient woke up with the symptoms. The patient's body temperature was 102 degrees F. The patient was seen by the physician and a flu test was performed, but she did no have the flu. The call was transferred from vaccine service center.
80 y.o. male with a PMH of COPD, CHF, HTN, DM II, hx of DVT, afib, pacemaker,  depression, PAD, HLD, depression, and recent viral pneumonia who presented to ED with shortness of air, worsening productive cough, generalized weakness, loss of appetite, body aches, subjective fevers, and chills. Patient presented to ED and was found to be hypoxic with spo2 of 80% requiring supplemental oxygenation and eventually had oxygen increase to 40L 70%. Patient had one episode of hypotension that resolved with 500ml fluid bolus. MICU was consulted due to increased high flow settings and deferred patient to progressive care. On assessment, patient's o2 saturation of 87% with RR of 35 on 35% 30 liters high flow nasal cannula. Increased the patient to 50% 35 liters with o2 saturation of 92%.   Constitutional: Positive for appetite change, chills, diaphoresis, fatigue and fever. Negative for unexpected weight change.  HENT: Negative for congestion, hearing loss, sore throat, tinnitus and trouble swallowing.        Loss of taste/smell  Eyes: Negative for pain, redness and visual disturbance.  Respiratory: Positive for cough and shortness of breath. Negative for wheezing.   Cardiovascular: Positive for palpitations. Negative for chest pain and leg swelling.       Chronic palpitations.    #Acute on chronic hypoxic respiratory failure 2/2 COVID 19-PNA c/b CAP in setting of severe COPD and HFrEF - reports of severe COPD on home O2 (unsure of settings) and HFrEF 20-25% - COVID-19 positive on 9/6/21; s/p J&J vaccine earlier this year - CT PE 9/6: negative for PE, b/l GGO and consolidation, L>R. emphysematous changes w/ peripheral blebs and airtrapping. Some peripheral honeycombing concerning for fibrotic changes with traction bronchiectasis - elevated d-dimer, LDH, CRP, and procal  - 9/6: started on remdesivir + dexamethasone 6 mg daily, CAP coverage with ceftriaxone and azithromycin - not currently a candidate for barcitinib per ID due AKI - on transfer to MICU, was on HFNC 60L @ 100%, but this is likely 2/2 agitation and patient intermittently removing cannula. Precedex started and able to wean HFNC to 50L @70%. Plan:  - Continue ceftriaxone for 5 days (thru 9/10) and azithromycin for 3 days (thru 9/8) for CAP coverage   Patient continued to decline after admission as expected ultimately to his death on 09/16/2021 at 1134AM .  Patient was pronounced dead by hospital bedside RN.