chrisvoncsefalvay/vaers-outcomes huggingface dataset:
suspected vaccination failure/had two doses of the vaccine and still got shingles; still got shingles; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     Additional Information: GSK receipt date: 20-Aug-2022 Reporter's comment: The case was received from the consumer via interactive digital media. The patient (school nurse) had two doses of the vaccine and still got shingles. Additional supportive information: This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
High blood sugars for 24 hours even with two additional doses foyr hours apart by injection of 10 units of Novolog Aspart insulin
Patient rec'd dose 1 of Moderna COVID-19 Vaccine 0.5 ml IM in Ldeltoid on 2/4/21 at 1430 at the facility. Approximately four days later a rash originating  in groin area was noted. On 2/11/21, RA contacted to report the rash wa Narrative: Patient rec'd dose 1 Moderna COVID Vaccine 0.5 ml IM in Ldeltoid on 2/4/21 at 1430 at the facility. Approximately four days later a rash originating  in groin area was noted. On 2/11/21, RA contacted to report the rash was vesicular  and had spread with dermatomal distribution, consistent with herpes zoster. Valtrex initiated.
Initial information received on 29-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional (office staff). This case involves a 15 months old female patient who was vaccinated with 0.5 ml second dose of ACT-HIB (Batch number: UI937AAA and expiration date: 05-Nov-2019) in the left thigh (route of administration not reported) on 28-Nov-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DTAP for Immunisation; PREVENAR for Immunisation; and INFLUENZA VACCINE for Immunisation. It was a case of actual medication error due to inappropriate reconstitution technique because ACTHIB was reconstituted with sterile water instead of the supplied 0.4% NaCl saline solution diluent. No symptoms were reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
A non-serious spontaneous report of expired FLUMIST administered was received from a pharmacist concerning a six-year-old female. Neither relevant medical history nor concomitant medications have been reported for this patient. On 08-Dec-2011, the patient received expired FLUMIST. The product expired on 27-Nov-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved.
This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar event for 3 patients. This is the 3rd of 3 reports. A patient of unspecified age, race/ethnicity and gender received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced arm swelling on an unspecified date with outcome of unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2017169079 Same product/event/reporter, different patient;US-PFIZER INC-2017169045 Same product/event/reporter, different patient.
Rash on both arms that lasts longer than 10 days and is growing worse if not helped by doctors. Very itchy sometimes.
Patient was brought to the ED by EMS on 11/15 for evaluation of vomiting and diarrhea, along with abdominal distension and intermittent abdominal pain. In the ED, she also reported cough, shortness of breath, chest pain, and right hip pain. While in the ED, she intermittently had O2 sats in high 80s and was placed on 2L NC O2. COVID-19 PCR test was done which was positive. Patient was admitted 11/15/22 - 11/21/22. Provider suspected her abdominal symptoms were related to COVID-19. She was able to be weaned off oxygen during admission.
A non-serious spontaneous report of administration of expired product was received from a health professional concerning a 30-year-old female subsequent to receiving FLUMIST. Neither relevant medical history nor concomitant medications were reported for this patient. The FLUMIST expired on 02-Jan-2011. The patient received the expired vaccine on 28-Jan-2011. There was no adverse event associated with this medication error; therefore, treatment and reporter causality assessments are not applicable, and the event is considered resolved. There were no late occurring adverse events. Additional information received on 25-Apr-2011 and incorporated into case: no late occurring adverse events.
Patient reports extreme pain in his left arm about 10 minutes after getting the vaccines. He reported after a day that a fever occurred, body pain, and chills/hot flashes that lasted 2 days.
Shot at 3 PM....symptoms began around 5 PM.  Achy arm....temperature rise of about 1.5 degrees...flu like aches, chills.
This spontaneous report as received from a nurse practitioner via a company representative refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with a dose of unidentified Merck human papillomavirus (HPV) vaccine (dose, route of administration, lot# and expiration date were not reported). The reporter did not know if it was GARDASIL or GARDASIL 9. On an unknown date after the vaccination, the patient developed a breast duct infection with bleeding. The outcome of the adverse events and the relatedness between them and unidentified Merck human papillomavirus (HPV) vaccine were not reported. Upon internal review, the events of breast duct infection and bleeding were considered to be medically significant. Additional information has been requested.
Received shot on day 4 of period cycle when it was winding down. About 24 hours after receiving, flow began to increase dramatically and continue for 48 hours, with many clots and cramping. Never experienced something like this before.
Information has been received from a medical assistant concerning an unspecified patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies and concurrent conditions were not informed. Concomitant therapies were not reported. On an unknown date, the patient was administered an improperly stored dose of  PROQUAD, lot # M022402, expiration date 01-NOV-2017, (dosage and therapy route were not provided), for prophylaxis. No adverse effects were reported. The dose of PROQUAD was exposed to a temperature of -12C during 3 hours 43 minutes and -10C during 7 hours 38 minutes. A data logger was used to track the temperature and there were no prior excursions. No product quality complaint (PQC) was involved. This is one of several reports from the same source. Additional information has been requested.
This spontaneous report was received from a physician assistant and refers to a 9 year old patient of an unknown gender, who had no history of wild type Varicella zoster virus. No information regarding the patient's concurrent conditions and concomitant therapies was provided. On an unknown date, the patient was vaccinated with a dose of Oka/Merck VARIVAX injection, subcutaneous (lot #, expiration date were not reported) for prophylaxis. On an unknown date, the patient was diagnosed with herpes zoster on the left upper extremity. The outcome of herpes zoster was unknown. Causality assessment was not reported.
She didn't have a good experience; She never went back for the second; No Adverse event; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (She didn't have a good experience), PRODUCT ADMINISTRATION INTERRUPTED (She never went back for the second) and NO ADVERSE EVENT (No Adverse event) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.   In February 2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (She didn't have a good experience), PRODUCT ADMINISTRATION INTERRUPTED (She never went back for the second) and NO ADVERSE EVENT (No Adverse event). At the time of the report, IMMUNISATION REACTION (She didn't have a good experience), PRODUCT ADMINISTRATION INTERRUPTED (She never went back for the second) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for IMMUNISATION REACTION (She didn't have a good experience) and PRODUCT ADMINISTRATION INTERRUPTED (She never went back for the second).    Concomitant Medication use information was not provided by reporter.  The patient took the first dose of the Moderna vaccine almost two years ago. It was around February 2020.   It was unknown if patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Treatment Medication use information was not provided by reporter.   Reporter did not allow further contact
Bright red rash and pain over entire body within hours after shot.  Hives by the following day.  Given Benadryl with relief.  Sent home from school.
A dose of 0.2 mL was administered instead of a dose of 0.3 mL
numerous small blister like, itchy lumps on my arms and legs; numerous small blister like, itchy lumps on my arms and legs; numerous small blister like, itchy lumps on my arms and legs; This case was reported by a consumer via interactive digital media and described the occurrence of blister in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox (had chicken pox when patient was in thirties).   On 14th September 2020, the patient received Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced blister, itchy rash and mass. On an unknown date, the outcome of the blister, itchy rash and mass were unknown.   It was unknown if the reporter considered the blister, itchy rash and mass to be related to Shingrix.  Additional details were provided as follows: The patient reported the case for themself. The age group was not reported but was selected as adult as per vaccine indication. The patient had Shingles vaccine two days before the date of reporting and since then had numerous small blister like, itchy lumps on arms and legs.  The patient asked if patient was contagious and reported that It looked exactly as it did when patient had chicken pox in thirties. The consent to contact the reporter was not reported.
Pt became very pale, limp and lethargic with fever (shock-collapse). He was unresponsive to external stimuli, even fireworks (we have this on video!) We called the doctor and were told, "just give him Tylenol". This lasted several days. He also did not nurse well. 60 Day FU states he has been diagnosed with encephalopathy and pervasive developmental disorder nos. He has developmental delays in all areas, but particularly communication and social with some autistic behaviors. He has problems with food allergies, malabsorption, and diarrhea.
I was fine until about 24 hours after the shot when I started feeling tired and having a headache and had major exhaustion and that?s when I started noticing my underarm and I really didn?t know what it was until Monday morning when I went to work. I asked a nurse I worked with and she said I was having lymph node reaction to shot. Dr said the same thing. It did move up my neck from my underarm after that and under my chin and eventually went away. This lasted about a week before it went away.
Developed serum sickness 1-2 days after vaccination.  Pt had received the influenza vaccine once prior last year.  He developed urticaria, hives, erythema multiforme type lesions, no mucosal lesions, diffuse swelling and tenderness of all joints
Numbness, tingling, burning pain in Left upper extremity, left lower extremity. Ongoing for 3 weeks, first started on day of Covid vaccination.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 10:42 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 10:42 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant product use was reported.  The age of patient was provided as 84.55.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  On 11-Jan-2021, Excursion time was 09 AM, temperature was 34, total doses given for the day was 98, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 05-Jan-2021, vial was moved to clinic on 08-Jan-2021. 02 vials were sent to clinic. Vaccine BUD date was 04-Feb-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. The temperature recordings were taken by using a Fisher brand traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  No treatment information was provided.
Pt recvd vax & several hrs p/vax exp severe h/a, hives & lethargy; pt has missed the last month of work because of it;
This medically confirmed report (initial receipt 30-Apr-2012) concerns a patient. The patient had an allergy to influenza virus vaccine (manufacturer and batch no. not specified) and experienced a rash and nausea. No further information was provided.
This nurse realized she gave (2) flu shots to (1) person vs giving a flu and pneumonia as intended.  She indicated there were (2) people in line and that she drew up (2) syringes with flu vaccine.  While patient was filling out consent form the client decided to get a pneumonia shot so nurse drew up a pneumonia shot and laid it by glove to know that is what it was.  She then gave flu shot and when she was supposed to grab the pneumonia she accidently grabbed the other syringe with the flu vaccine and administered.  Nurse stated that she did not notice this error until serving the next client.  Nurse noticed that the syringe was still sitting by the glove and she knew that is where she sat the pneumonia vaccine filled syringe. Flu coordinator notified patient of possible side effects.  Flu coordinator verified possible side effects with flu manufacturer.  Flu coordinator notified patient physician...no orders given  Right arm sore.  Patient complained of chills, sick to stomach, lack of hunger, vomited, dizziness.
This spontaneous report as received from a other health professional refers to a patient of unknown age. On 01-APR-2017 the patient was vaccinated with VAQTA for prophylaxis.  On 01-APR-2017, 1 day after onset of therapy the patient experienced incorrect product storage. On an unknown date the patient experienced no adverse event. The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage and no adverse event to be not related to VAQTA. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1708USA003618: US-009507513-1708USA004162: US-009507513-1708USA004160:
pt states started w/red, raised areas on lt arm & down lt side to knee w/itching; rash started approx 5-6 hrs p/vax; mom states area look like ringworms-taking DPH for itching;
02/08/22 presents to ED for "Breathing Problem". PMHx of "non-Hodgkin's lymphoma (on chemo), empyema, Afib, asthma"
w/in 3hr of vax red, inflamed rt arm, from elbow to shoulder;edema 4+ lasted 4 days, pruritis, pain;tx w/ice, DPH;
No Adverse event; administered the pediatric Moderna COVID-19 for 6-11 years to 3 patients, instead of the bivalent Moderna booster; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (administered the pediatric Moderna COVID-19 for 6-11 years to 3 patients, instead of the bivalent Moderna booster) and NO ADVERSE EVENT (No Adverse event) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 064A22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Sep-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 27-Sep-2022, the patient experienced WRONG PRODUCT ADMINISTERED (administered the pediatric Moderna COVID-19 for 6-11 years to 3 patients, instead of the bivalent Moderna booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (administered the pediatric Moderna COVID-19 for 6-11 years to 3 patients, instead of the bivalent Moderna booster) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (administered the pediatric Moderna COVID-19 for 6-11 years to 3 patients, instead of the bivalent Moderna booster).    No concomitant medications was reported.  The patient has not reported an adverse reactions at that point.  No treatment drug details was reported.
I, as well as my sister experienced Tinnitus and it has not subsided.. it is either a ringing or a hissing sound. Sometimes we get earaches.. we have been to many ENTs as well as blood and hearing tests.. no one knows what to do.
VAERS completed because of being Tested positive for COVID-19 infection 14 or more days after being fully vaccinated. 1st dose01/12/21 pfizer,Lot#EL3248 2nd dose: 02/02/21, Pfizer,Lot# EN5318 Diagnosed covid positive:07/28/21 Symptom onset:07/27/21 Exposure:unknown Symptoms:cough, fatigue,loss of smell/taste,muscle aches, sore throat, chills, nausea.
Moderna Dose 1 3/29/21 (039A21A) Moderna Dose 2 4/26/21 (048B21A) COVID Positive 1/4/22  1/13/22: Patient is a 71 year old male who presented to ED via EMS with complaints of generalized weakness. Patient has been vaccinated against COVID-19, did not receive his booster. He was seen in ED on 1/4 and tested positive for Covid-19. He was discharged home with the Covid home program. Per chart review the patient was contacted on 1/7 and stated he was "getting better" and would prefer not to participate in the program. Patient stated his symptoms worsened five days after testing positive for Covid. He has been experiencing extreme fatigue, nausea and diarrhea for the past 4 days.  He has been unable to tolerate food or fluids in the past 4 days. He has become progressively short of breath over the past several days. He has a past medical history of hypertension, borderline diabetes, and cirrhosis secondary to alcohol use.   On arrival to ED the patient was hypoxic on room air at 83%, 15 L OxyMask was applied on arrival to ED with improvement oxygen saturations, patient was weaned down to 10 L. laboratory findings were significant for mild hypokalemia 3.6.  Hyperglycemia 151.  Transaminitis AST 57 in ALP 151. Hyperbilirubinemia 1.4.  Lactic acidosis 3.9. PH 7.46 pCO2 32 PO2 67. D-dimer 3.41.  Chest x-ray shows interval worsening with diffuse multifocal bilateral airspace disease.  Azithromycin and ceftriaxone were initiated in ED.  Patient received DuoNeb treatment.  IV hydration was given with NS 0.9% 1 L.  1/20/22: 71-year-old male with no significant past medical history apart from alcohol abuse and liver cirrhosis who presented to the emergency department with shortness of breath admitted for COVID-19 pneumonia.  Pt was started on Rocephin and Zithromax, he received Actemra, no remdesivir due to liver cirrhosis, was on Lovenox twice a day, and Decadron.  Oxygen requirement were high initially but was successfully weaned down to 2 L by nasal cannula. Currently seems to be stable for discharge.  Will discharge to skilled nursing facility per PT/OT evaluation.