chrisvoncsefalvay/vaers-outcomes huggingface dataset:
all or part of their dose was administered subcutaneously; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of INCORRECT ROUTE OF PRODUCT ADMINISTRATION (all or part of their dose was administered subcutaneously) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021 at 10:55 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021 at 10:40 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INCORRECT ROUTE OF PRODUCT ADMINISTRATION (all or part of their dose was administered subcutaneously). At the time of the report, INCORRECT ROUTE OF PRODUCT ADMINISTRATION (all or part of their dose was administered subcutaneously) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment medications were provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Patient Identifiers updated
RASH AND SWELLING AROUND INJECTION SITE, RUNNING UP AND DOWN THE ENTIRE ARM. SEVERE PAIN WITH THE SWELLING CAUSING THE SKIN TO SPLIT DUE TO EXCESSIVE SWELLING.  THIS LASTED FOR THREE DAYS AS IT RESOLVED LEFT BRUISING FROM SHOULDER TO FOREARM. TREATED WITH ICE-PACKS AND IBUPROFEN.
The patient received her third dose of Pfizer Covid vaccine on 11/10/21. The following day, she developed raised bumps around the injection site. She went to the dermatologist that day and they diagnosed her with shingles. She now has shingles from her left elbow, to her back.
urticaria on the 5th day p/2nd booster inject; sx lasted 5 or 6 days & responded to conservative supportive tx;
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2010, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain condition of herpes zoster. In July 2016, the patient was treated at an emergency room for blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome is unknown. Additional information has been requested.
Pt is a 19 yo M with a documented allergy to PERTUSSIS VACCINES (Other Reaction: SCREAMING FOR 2; severity: medium; since 6/20/2012). On 12/16/13, pt presented to clinic for annual exam. During visit, pt was ordered Tdap vaccine. The allergy was noted & discussed with the pt. Based on the pt's report that this was not a substantial concern, the decision was made to administer the Tdap vaccine. 0.5 mL was given IM in left deltoid (Mfg: GSK, Lot #2RY59, Exp: 3/13/2016; NDC #58160-842-52). Pt denied any adverse effects after injection & was discharged home in stable condition. On 12/17, pt awoke w/ nausea & vomiting x 1. Pt's mother called clinic & reported symptoms. MD charted "It is possible that his symptoms this morning are related to the pertussis vaccine given yesterday but it is difficult to know for sure. I spoke with both [pt] & his mother at length & apologized for the concerns that have arisen based on his symptoms. The symptoms are improving through the day & he is doing better, but I acknowledged that further clarification of the concerns surrounding the pertussis vaccine should have been taken." On 12/17/2013, pt's allergy profile was updated to include PERTUSSIS VACCINES (OTHER REACTION-CONCERN FOR ALLERGIC SYMPTOMS - MUST NOT RECEIVE ANY PERTUSSIS VACCINE; severity: medium).
FEELING SLEEPY; BODY ACHES; HEADACHE; TEMPERATURE OF 101.8 F; SKIN HURTING; This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 166 pounds, and height was not reported. The patient's past medical history included covid-19 and concurrent conditions included penicillin allergy, non alcoholic, and non smoker and other pre-existing medical conditions included patient had no drug abuse or no illicit drug usage. The patient experienced drug allergy when treated with cefalexin. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805031, and expiry: UNKNOWN) dose was not reported, administered on 25-MAR-2021in right arm for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the subject experienced skin hurting. On MAR-2021, the subject experienced temperature of 101.8 f. Laboratory data included: Body temperature (NR: not provided) 101.8 F. On 25-MAR-2021, the subject experienced feeling sleepy. On 25-MAR-2021, the subject experienced body aches. On 25-MAR-2021, the subject experienced headache. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from skin hurting, and had not recovered from feeling sleepy, headache, body aches, and temperature of 101.8 f. This report was non-serious.  Version created to amend previously reported information on 25-Mar-2021. Upon review, the following information was amended: Narrative inconsistency corrected.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition or medical history reported. On an unknown date in June 2012, the patient was vaccinated with ZOSTAVAX vial (dose and route unspecified). On an unknown date in October 2013, the patient was vaccinated with the second dose (an extra dose) of ZOSTAVAX. No adverse experience reported. No product quality complaint reported. Additional information has been requested.
PER PATIENT SHE WAS WEAK, DIZZY AND FEELING FAINT.  STATES SHE FELL THE DAY AFTER THE VACCINE AND HIT HER HEAD.   SITE ON TEMPLE OOZING.  SLEPT MANY HOURS WHICH IS UNUSUAL FOR HER
Patient marked on her form that she had received a Jansen Covid 19 vaccine on 2-1-21. This information was overlooked prior to giving her the first dose of the Pfizer vaccine. It was verified  that patient did in fact receive a J&J shot on 3-8-21 and then received her first dose of Pfizer on 6-28-21. Patient states that she had no side effects from the Pfizer shot and that her arm was less sore after the Pfizer vaccine then the J&J. She was told by our pharmacy that she would be unable to get her 2nd dose of Pfizer and she completely understood why after we talked in length about the vaccines.
Developed left sided neck swelling 1 day after vaccination. Left sided neck swelling was associated with lymphadenopathy. Persisted for 3 weeks before spontaneously improving. Patient also developed a rash (biopsy confirmed leukocytoclastic vasculitis)  about 2 weeks after vaccination, which persisted 5 days before resolving.
Initial report received from a health care professional on 27 September 2012. A female patient (age not reported) received FLUZONE vaccine intramuscularly in her left deltoid (batch number: UH716AB) on 20 September 2012. The patient's illness at the time of vaccination was none. The patients preexisting illness included HTN and allergic to PCN. The patient also had a scar at the site of previous vaccination (unknown vaccine). Concomitant medications were not reported. On 20 September 2012, the patient developed redness, swelling, induration at an area of her arm 3 inches from the injection site. This was the same location where she had an old scar from a previous vaccine. The area was tender and painful to touch, and the whole arm hurt when she tried to move. The lab investigations were none and treatment medications were not reported. At the time of this report, the outcome was reported as not recovered. Documents held by sender: none.
Right leg started swelling (below knee) for some weeks; having difficulty breathing; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 60-years-old non-pregnant female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EL9262), via an unspecified route of administration in arm left on 28Jan2021 at 09:00 (at the age of 60-years-old) as dose 2, single for COVID-19 immunisation. The medical history of the patient included known allergies of penicillin. The concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient previously took first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: EJ1686), via an unspecified route of administration in arm left on an unspecified date in Jan2021 at 10:15 as single dose for COVID-19 immunisation. 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. Since the vaccination, the patient not been tested with covid-19. The patient experienced right leg started swelling (below knee) for some weeks and having difficulty breathing on an unspecified date in Feb2021. The events resulted in emergency room visit. The patient underwent lab tests and procedures which included chest x-ray: unknown results on an unspecified date and ultrasound of leg: unknown results on an unspecified date. Therapeutic measures were taken as a result of events that included ultrasound of leg and chest Xray. The outcome of the events was reported as resolving.  No follow-up attempts are possible. No further information is expected.
Nurse administered an expired dose; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 55-year-old male patient who received HAV (Havrix) (batch number unknown, expiry date 14th June 2022) for prophylaxis.   On 21st June 2022, the patient received Havrix. On 21st June 2022, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 22-Jun-2022 Reporters comment: The reporter could not find the lot number at time of call. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. Additional Supportive Information: The patient received Havrix which was already expired in 14th June 2022 which led to expired vaccine used.
pt devel rash as upper body (chest, back, arms, face); also had itching as these areas;pt retreated w/DPH & hydrocortisone cream topical 1%;
temp 100.5 and rash all over b ody that looks like pimples per guardian
Angioedema, uticaria, difficulty breathing, fever, headache, myalgia, and stomachache devel 10/31/99, post vax. 2nd dose of Flu Shield rcv'd w/out AE.
This is a spontaneous report received from a contactable physician (patient's husband). A 72-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), intramuscular in the left deltoid on 05Jun2018 at single dose to prevent pneumonia. There were no medical history and concomitant medications reported. On 05Jun2018, it was reported that the patient had a side reaction on her left deltoid which despite a BENADRYL and steroid ointment on it, it was spreading. It was described as like the diameter of half a tennis ball and about half of the half of a tennis ball size that was quiet raised, tender and very red. The husband was asking for treatment that the patient can take for the rash that she was having. It was reported that the area of redness is not as red as it was but it is spreading upwards, all the way up above the shoulder and downwards towards the patient's elbow, around the back and all. The husband added that through the next few days it was less tender but itchy and firm only in one three or four centimeter area right around the injection site. On 05Jun2018, the patient also had nausea, lack of appetite and chills. The outcome of events 'quiet raised, tender and very red' (vaccination site erythema and pain) was recovering; events 'nausea' and 'chills' recovered on unspecified date; all other events was unknown.
Heart Arrhythmia and Discomfort/Pain in left side of chest due to pericarditis/ pericardial effusion. Symptoms developed approximately 10 days after receiving second dose of Moderna Covid-19 vaccination. Medical testing to determine resulting heart issues described above are listed in Section 19 below.
Myalgia; Fatigue; Shivering; Headache; GI symptoms; This case was reported by a other health professional via interactive digital media and described the occurrence of myalgia in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th November 2020, the patient received Shingrix. In November 2020, less than a day after receiving Shingrix, the patient experienced myalgia, fatigue, shivering, headache and gastrointestinal symptom nos. On an unknown date, the outcome of the myalgia, fatigue, shivering, headache and gastrointestinal symptom nos were not recovered/not resolved.   It was unknown if the reporter considered the myalgia, fatigue, shivering, headache and gastrointestinal symptom nos to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was selected as an adult as per the vaccine indication. The patient complained of myalgia, fatigue, shivering, headache, and gastrointestinal symptoms and now persisting 9 days. The reporter wanted to know how long do these side effects last.
expired lot numbers administered to patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired lot numbers administered to patients) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 EXPIRED PRODUCT ADMINISTERED (expired lot numbers administered to patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired lot numbers administered to patients) 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.
Patient called today to state that he had a reaction to his pneumovax 23 given on 10/9/19 his arm has redness 4-5 inches below the injection site, it wraps around the armpit and down to the elbow. I did tell him that I would be reporting this reaction via VAERS. he did contact his dr about the reaction and sent me photos of the reaction. He was told by his dr to take augmentin that he had on-hand at home. He said that he was not experiencing any aches, pains, or fever at the time of reporting.
severe muscle aches; yeast infection; thrush; This is a spontaneous report from a non-contactable consumer or other non hcp (patient). A 59-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EP6955), via an unspecified route of administration, administered in Arm Left on 02Apr2021 08:15 as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Patient had no known allergies. Patient was not pregnant at the time of vaccination. Concomitant medications included estradiol (ESTROGEN) taken for an unspecified indication, start and stop date were not reported; progesterone taken for an unspecified indication, start and stop date were not reported; rizatriptan taken for an unspecified indication, start and stop date were not reported; nortriptyline taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EN6206), via an unspecified route of administration, administered in Arm Left on 12Mar2021 08:15AM (at the age of 59-year-old) as dose 1, single for covid-19 immunisation and experienced severe muscle aches on day 2 post shot. On 06Apr2021, the patient experienced severe muscle aches, yeast infection, thrush. Therapeutic measures were taken as a result of events included Fluconazole, Nystatin. The events resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected.
bruising / extreme fatigue/ soreness at injection site/ body aches / shingles symptoms started within 36 hours of injection
Initial information received on 17-Sep-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves 20 elderly patient who received expired doses of vaccine FLUZONE HIGH DOSE (lot number not reported) via unknown route on unknown dates. The patients' past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to expired vaccine used as it was reported that new FLUZONE HIGH DOSE was mixed with last year's supply of FLUZONE HIGH DOSE. It was unknown if the patient experienced any adverse event or not following the administration of the vaccine. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Patient reported feeling nauseated and lightheaded. 1040 a blood pressure 184/102, HR 91, Pulse ox was 99%. She continued to feel funny and lungs were clear. Physician stated the pt sounded tachy. At 1045 the B/P was 157/92, HR 96. At 1050 the B/P was 134/90. Physician spoke with the pt and informed her that she might be having a panic attack. He was talking with her and the HR was coming down. Another nurse  came to help. At 1055 the pt looked pale, became more nauseated and started to dry heave, they lowered the pt to the floor laying on the right side with no LOC. Another RN was called to help. She started to get the 0.9 %NS ready and got the 22 G ready. 911 was called by a lab tech, the husband was called, and a message was left. A medical emergency was called.  RN arrived at 1055 and started the IV in the right antecubital.  second RN arrived  and started recording the events. The accu check machine was brought over by lab staff and a blood sugar was checked at 1100 to be 105. The pt remained pale and stated she is feeling fuzzy and lightheaded. Her legs were tingling and she just wants to go to sleep. B/P was 106/62 HR 60 pulse ox 95%.  The EMT team arrived and the pt was able to get to the sitting position. She was helped with 2 assist to her feet to get to the EMT cart. The pt's glasses, keys, sweatshirt purse, and bag was given to the EMT to take to the Hospital. The pt's husband called back and states he received the message and was at the hospital. The pt's husband was updated and was informed to stay at the hospital and the ambulance was on it's way.
Information has been received from a medical assistant concerning a 23 year old female patient with allergy to ULTRAM, NEURONTIN, tramadol hydrochloride (unspecified), PERCODAN, VICODIN and atropine sulfate and no pertinent medical history who on 18-MAR-2010, was vaccinated with a 0.5 ml IM dose of GARDASIL (lot # 663573/0969Y). Concomitant therapy included amoxicillin, ERYTHROCIN, BACTRIM DS, and ALLERGY DROPS. On 18-MAR-2010 or 19-MAR-2010, the patient experienced a pruritic rash on her neck and left upper chest, a yeast infection for two days, dysphagia, tightness of throat, sore throat and fever. The patient was treated with BENADRYL and MONISTAT. No lab diagnostics studies were performed. At the time of reporting, the outcome was unknown. The patient sought medical attention via office visit. Additional information has been requested.
Initial information received on 17-Oct-2018 regarding an unsolicited valid non-serious case received from a physician. This case involves an unknown age male patient who experienced phantosmia, while he received vaccine ADACEL. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications were not reported. On an unknown date roughly in 2010, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot number not reported) via unknown route in unknown administration site. On an unknown date, the patient developed a non-serious phantosmia (parosmia) 2 weeks following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE. Final diagnosis was phantosmia. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Not recovered/Not resolved on an unknown date for phantosmia. It was reported that the event persists periodically today but not as intense. List of documents held by sender: none.
Raised 7 cm swelling and redness at injection site which was the left forearm over the brachioradialis.  Injection was given intradermally and it raised a tunnel in the skin.
No adverse reaction. Patient hospitalized in December for COVID. Given FFP while hospitalized. Patient given 1st Moderna vaccine 1-28-21 which was not 90 days after the FFP.
Less than 5 min after dose, complained of throat slightly swelling but no anxiety sorry about breathing.  Did not notify workers at site because didn?t think serious.  Lasted about 45 min.  Drove self home.  Mom gave Benadryl and watched for 2 hours.  Symptoms did not return.   This was drive thru clinic and window down.  Very allergic to pollen and symptoms resolved soon after window back up. Unknown if seasonal allergy reaction. (Has had same reaction to pollen in past) or vaccine.   No further issues. No other symptoms.
2.5 cm x 3 cm raised red area to lateral (L) leg. Pt's mother gave appropriate dose of ADVIL for child's wt upon discovery.