chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information has been received from a pharmacist concerning an 86 year old male patient with chronic respiratory disease and no known drug allergies who in approximately 2004 (at least 5 years ago) was vaccinated with a dose of PNEUMOVAX 23 (lot#, route and site of administration not reported). On 16-OCT-2009 the patient was vaccinated intramuscularly with another 0.5ml dose of PNEUMOVAX 23 vaccine (lot# 662841/0626Y) into the left arm. Concomitant therapy included PLAVIX, " blood pressure medication" and "cholesterol medication". On 16-OCT-2009 30 minutes after vaccination, the patient experienced body aches. It was reported that the patient was experiencing joint pain and pain in the left shoulder. Unspecified medical attention was sought and there was no laboratory diagnostics studies performed. Additional information has been received from a consumer, the 86 year old male patient's wife who stated the patient had a history of mild stroke and hypertension. She reported that in approximately 2001 (8 years ago) the patient was vaccinated with a dose of the influenza virus vaccine (unspecified) (lot#, route and site of administration not reported) and a dose of PNEUMOVAX 23 vaccine (lot#, route and site of administration not reported) with no adverse symptoms. On approximately 02-OCT-2009 (2 weeks ago) was vaccinated with another dose of the influenza virus vaccine (unspecified) (lot#, route and site of administration not reported). On 16-OCT-2009 the patient was vaccinated intramuscularly with another 0.5ml dose of PNEUMOVAX 23 vaccine (lot# 662841/0626Y) into the left arm. Concomitant therapy included PROCARDIA, ZOCOR, PLAVIX and BENICAR. On 16-OCT-2009 the patient experienced pain in the neck and shoulder immediately. Heat and pain started a few hours later followed by pain in the arm. The patient was treated with TYLENOL and ADVIL. On an unspecified date, the patient recovered. This is one of several reports from the same source. Additional information has been requested.
Erythema & swelling 24 hours after injection site - (R) leg. Itching, red & indurated, irregular borders. Antihistamine (Zyrtec) & ice to site, Tylenol prn. Cephalexin 250/5 if progressive inflammation & fever & tenderness develop.
4month old was accidentally given HepA vaccine (brother was in the room and needed this vaccine). No adverse effects have been identified as of this time.  I did call the department of health and then notified mom of the error.  they will contact us if there is any concerns for side effects or adverse outcomes.
This spontaneous report as received from a licensed practical nurse (also reported as registered nurse), refers to a 41 year old patient of unknown gender. No pertinent medical history or drug reactions/allergies were provided. On 04-NOV-2013, the patient was vaccinated with MMR II (Lot number J003625; expiry date 22-MAR-2015; dose and route not provided). No co-suspect or concomitant therapies were reported. It was reported that the MMR II administered to the patient was exposed to temperatures above 8 degrees C (between 8.09 and 22.73 degrees C) during 42.78 hours, from 05-OCT-2013 until 09-OCT-2013. No adverse effect had been reported. This is one of several reports from the same reporter. Additional information has been requested.
Primary Physician recommended I see a Dermatologist, which I did on 06/16/2021 and she concluded the malady was a result of "bruising".  I believe I have "Covid Arm" which I experienced the first day after the first shot. Initialy it was just my right arm, but following the second shot I developed it in both arms. I have a rash on my upper and lower right arm and a rash on my lower left arm. My hands and ankles often itch. I also have recurring red areas which were present on the second day after the first and second shot and only in my biceps area. I experience days of tiredness, and sometimes fatigue. I currently have all these symptoms.  DOB is 05/30/1940.
reaction to the COVID-19 vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (reaction to the COVID-19 vaccine) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (reaction to the COVID-19 vaccine). At the time of the report, VACCINATION COMPLICATION (reaction to the COVID-19 vaccine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter stated that her provider had a reaction to the COVID-19 vaccine. Reporter did not report the severity of the reaction.  Concomitant medications were not provided. Treatment information was not provided.
WITHIN A WEEK AFTER GETTING VACCINE PATIENT STOPPED GIVING US EYE CONTACT, THE MILD TALKING "DADA" HE USED TO DO PRIOR TO VACCINE STOPPED. I BEGAN THEN TO WONDER THAT THE VACCINE CAUSED THIS. HE STARTED DOING REPETITIVE MOVEMENTS SHORTLY THEREAFTER. I DISCUSSED CONCERNS WITH PROVIDER AT HIS 15 MONTH WELL VISIT AND HE BEGAN EARLY INTERVENTION SHORTLY THEREAFTER.
No additional AE reported.; A nurse reported V ARlV AX was improperly stored and administered.; This spontaneous report was received from a licensed practical nurse regarding a 4 year old female patient with 1 sibling, birth weight of 8.7 lb. Her concomitant therapies included measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II).  Since 02-DEC-2020, the varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursions with a total of 29.5h.    On 12-JAN-2021, the patient was vaccinated with her first dose of this improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) lot# T017686, expiration date 21-MAY-2022, subcutaneously in the Right Arm, for prophylaxis, on a private doctor's office/hospital with public funds.  This is one of several reports from the same reporter (US-009507513-2101USA011364).; Sender's Comments:  US-009507513-2101USA011364:Original Case : 2101USA011364
, Additional Details: instructed patient to continue taking ibuprofen and to follow up with primary care doctor
patient received a FLUZONE HIGH-DOSE QUADRIVALENT VACCINE twice within a one-month period with no reported adverse event; Initial information received on 18-Oct-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves an unknown age/gender patient who experienced patient received a fluzone high-dose quadrivalent vaccine twice within a one-month period with no reported adverse event while receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 16-Sep-2022, the patient received a  dose 1 of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE lot number not reported via unknown route in unknown administration site. On 17-Oct-2022 also received a  dose 2 of the same vaccine with an (strength, dose, formulation route,batch number: unknown)  in unknown administration site for immunization.  On 17-OCT-2022 the patient reported a non-serious event patient received a fluzone high-dose quadrivalent vaccine twice within a one-month period with no reported adverse event (inappropriate schedule of product administration) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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 the 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.
Flu-like Symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 64-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 13th January 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional information was provided as follows: After the first dose the patient felt like he had flu like symptoms which lasted one day. The reporter did not consent to follow up. Caller refused to give the HCP's contact information. She stated she would call herself For tolerance of 2nd dose, refer case US2020AMR122269.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR122269:same patient
Rotator cuff arthropathy. Surgery Right - right reverse total shoulder arthroplasty. The patient tolerated the surgical procedure without complications and was hospitalized for a total of 5 nights following the surgical procedure. Hospital admission within 6 weeks of receiving the COVID vaccine.
This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age and gender. Information regarding relevant medical history, concurrent condition and concomitant medications were not reported. On unknown dates, the patients were vaccinated with improperly stored PNEUMOVAX 23 (lot # M013156 with expiration date 15-OCT-2017, or lot # M005287 expiration date 18-OCT-2017, dose and route not reported). No adverse effects reported. This is one of several reports received from the same source. Additional information is not expected because we are not allowed to contact the reporter.
Pain includes achiness in neck; Pain in shoulder; Nausea; Headache; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (Pain includes achiness in neck), ARTHRALGIA (Pain in shoulder), NAUSEA (Nausea) and HEADACHE (Headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced NECK PAIN (Pain includes achiness in neck), ARTHRALGIA (Pain in shoulder), NAUSEA (Nausea) and HEADACHE (Headache). At the time of the report, NECK PAIN (Pain includes achiness in neck), ARTHRALGIA (Pain in shoulder), NAUSEA (Nausea) and HEADACHE (Headache) outcome was unknown.            Concomitant product information was not provided.  Treatment information was not included but patient want to know to take Acetaminophen
About 10 hours after I received the vaccine I started to get a headache, then about an hour later I have a fever of 100 and body aches. My left arm (where I got the vaccine) also hurt starting around three hours after the shot and hurt so bad that I couldn?t sleep
HR 126-67; SPO2-98; BP 154/80;  pt. was fine after vaccine then got out of car to use bathroom and as soon as he stood up from the car he lost balance and stated feeling dizzy, light headed and didn't feel right.  he Slumped over and was caught by an observer and guided to the ground.   Hypoglycemic but not diagnosed.  B/S 107.  pale, nauseaous.  care transferred to the paramedics.
Patient stated he felt dizzy, lightheaded and nausea .  BP 113/68, RR 18, HR 54, SPO2 96%.  10ml diphenhydramine administered PO at 1:38.  911 called when staff member's symptoms did not resolve.  EMTs arrived but staff member refused to be transported to hospital.  EMT's assessed staff and released secondary to stable.  Staff member's family came to take staff member home.
Never received the second dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose, one and half year ago from the date of reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient received first dose at a different pharmacy, so pharmacist did not have exact date of dose, or lot number or expiration date of 1st dose.   Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. The reporter consented to follow up.
Dizziness; Nausea; temperature of 99.2; This is a spontaneous report from a contactable consumer. A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: ER8727), via an unspecified route of administration, administered in upper right arm on 22Mar2021 at 10:20 (at the age of 56-year-old) as dose 1, single for COVID-19 immunisation. Medical history included gallstone from Oct2019. The patient's concomitant medications were not reported. The patient had first vaccine this past Monday on 22Mar2021, then when woke up in morning, she had no side effects right after the vaccine but she woke up this morning on 26Mar2021 with dizziness and nausea and her temperature, it was not high but it was at 99.2 and it was usually below 98.6 and she was calling to ask whether it was possible to have this 5 days after the vaccine or should she be thinking about getting a COVID test. The dizziness improved but then the nausea started. She confirmed the nausea started on 26Mar2021. That had worsened, it came on after the dizziness. The dizziness seemed to improve after breakfast but after eating the nausea started. Then she took her temperature, and she had a low grade temp which also began on 26Mar2021 and it was 99.2. The patient underwent lab tests and procedures which included body temperature: 99.2   on 26Mar2021. The outcome was reported as recovering for dizziness, not recovered for nausea and unknown for temperature of 99.2.  No follow-up attempts are possible. No further information is expected.
Refrigeration excursions identified/undergone several temperature excursions; No adverse event; Bivalent vaccines have undergone several temperature excursions and have been administered to patient; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) in a 31-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS1746B) for COVID-19 prophylaxis.     It was unknown that the patient ever been diagnosed with/ tested positive for COVID-19.     On 25-Sep-2022 at 4:41 PM, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On 25-Sep-2022 at 4:41 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions), POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (Refrigeration excursions identified/undergone several temperature excursions) and POOR QUALITY PRODUCT ADMINISTERED (Bivalent vaccines have undergone several temperature excursions and have been administered to patient).    No concomitant product reported by the reporter. Patient had received previous 3 doses of vaccine, intramuscular with anatomical site as deltoid. Dose 4 anatomical site was also reported as deltoid. Bivalent vaccines stored in the refrigerator that underwent several temperature excursions in August 2022. Refrigeration excursions were identified, vaccine was housed in the units. There were excursions noted. Manufactures were notified and the department was made aware of the situation.  No adverse reactions were reported for any of the patients at the time of the report. No treatment medication reported by the reporter.
Subject in pneumococcal vaccine trial, with severe COPD, was hospitalized for Pneumothorax. Vaccination took place 1/27/2009. According to the physician the relationship is 'None'. We would be happy to forward the Study's SAE reporting form upon request.  10/1/09 D/C Summary received for DOS 8/6-10/2009 with DX:  Left Pneumothorax.  Pt was receiving a CT guided lung biopsy for a lung nodule when pt suffered a >30% pneumothorax.  Chest tubes placed x 2 and admitted for observation in RICU.  SubQ epmphysema and decreased breath sounds noted on the Left. Concurrent COPD exacerbation. Ptx resolved and pt to f/u as outpt.
Resident reported feeling of throat "closing off" upon return to Nursing Home facility after receiving her second COVID-19 vaccine at Dr. office. Resident then vomited large amount of liquid. At that time resident denied any shortness of breath or difficulty breathing. Vital signs stable. Tylenol and Bendaryl ordered and given by Nursing Home Nurse Practitioner. Resident did not require higher level of care.
Tingling lips; Burning lips; Swelling of injection site; Tenderness of injection site; Burning sensation; This spontaneous case was reported by an other health care professional and describes the occurrence of BURNING SENSATION (Burning sensation), PARAESTHESIA ORAL (Tingling lips), ORAL DISCOMFORT (Burning lips), INJECTION SITE SWELLING (Swelling of injection site) and INJECTION SITE PAIN (Tenderness of injection site) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination.     Concurrent medical conditions included Premature atrial contraction, Post concussion syndrome, Chronic migraine, Tendinitis (around right ankle), Drug allergy (codeine (suicidal ideation)), Topical adhesive allergy (rash) and Contrast media allergy (generalized delayed rash).    On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Aug-2021, the patient experienced BURNING SENSATION (Burning sensation), ORAL DISCOMFORT (Burning lips), INJECTION SITE SWELLING (Swelling of injection site) and INJECTION SITE PAIN (Tenderness of injection site). On an unknown date, the patient experienced PARAESTHESIA ORAL (Tingling lips). At the time of the report, BURNING SENSATION (Burning sensation), PARAESTHESIA ORAL (Tingling lips) and ORAL DISCOMFORT (Burning lips) was resolving and INJECTION SITE SWELLING (Swelling of injection site) and INJECTION SITE PAIN (Tenderness of injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No treatment information was provided.
Patient received vaccine at 1005 and approx. 20 minutes later reports "tickle" in throat feeling the urge to clear throat. and "tingling' of lips.  Benadryl 50g given by mouth per standing order.  Monitored for additional 30 min.  30 min after administration of benadry  Patient reported no change to symptoms.  Patient was escorted to ER to  be seen.
Extreme chills causing full body shaking Extreme fatigue to the point that holding head up and staying conscious was difficult Mild Fever  All started about 12hrs after the vaccine and lasted about 32hrs
autoimmune inflammation response; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of INFLAMMATION (autoimmune inflammation response) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLAMMATION (autoimmune inflammation response). At the time of the report, INFLAMMATION (autoimmune inflammation response) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication information was reported. Patient experienced an autoimmune inflammation response.   Reporter did not allow further contact
Within 5 minutes, felt a lump in my throat and continued throat closure almost to the point of having difficulty breathing.  Pharmacist provided 10mg of Benadryl. Took 1.5 hours for throat issue subsided. Did not have any reaction to the first 2 shots like this.  2 hours later, after resting for an hour significant loud high pitched ringing began in my left ear. Ringing has not stopped, now 46 hours later.  Severe fatigue, moderate headaches and difficulty sleeping since the shot was administered.
pt devel nausea & abdo pain; also had vomiting; no diarrhea & no fever; will restart vax on 22JAN93;
The morning after the vaccination I experienced very sore/burning sensation in my left armpit and left upper arm underneath. A few days later I experienced pain in my left groin area. The arm pain lasted about a week and is mildly there at times still. The pain in the groin remains. It is important to note that I had this shingles vaccination five days after having a Covid booster vaccine. Moderna
12 hours after receiving vaccine, patient developed sweats, chills, temperature to 101.4, and myalgias. Symptoms lasted 48 hours. Over last 24 hours patient has developed redness and itching over the injection site on the right arm.
Pain, warmth at injection site. A quarter sized lump around injection site appeared 4 hours post injection.
pt recvd vax for prophylaxis;24 hrs later exp nausea & aches/pains; resolved
Had tenderness to Left arm on 12/15/18. Patient developed red lesions to left arm on 12/19/18.
Began 3/21/03 at about 10 papules, few red papules and a few papules with pin-point scabs on calf, neck and buttocks. Afebrile. Guardian had shingles X 3 weeks and baby-sits child 2-3 days a week.
L thigh redness, induration, cellulitis ~ 10cm at site of Hib #4 shot.
Complaints of pains in legs where vaccine was administered. Woke in the morning with fever that lasted for about 14 hours.
"covid arm"...skin reaction 8 days after shot was administered.  Area of redness, swelling, soreness and itching on the arm where the shot was given.  area of reaction is about 4 inches long and 2 inches wide.