chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. Previously administered products included Tdap with an associated reaction of injection site pain (received in 2015, refer case US2018GSK163780). On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced influenza-like symptoms, fever, fatigue, shivering, malaise and activities of daily living impaired. On an unknown date, the outcome of the influenza-like symptoms and fever were unknown and the outcome of the fatigue, shivering, malaise and activities of daily living impaired were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, fever, fatigue, shivering, malaise and activities of daily living impaired to be related to SHINGRIX. Additional details were reported as follows: The patient reactions from SHINGRIX 1st dose included fever and flu-like symptoms within 6 hours of the vaccination. The patient also experienced extreme fatigue, shivering, malaise, unable to carry on with regular routine for almost 72 hours. The patient had a Tdap vaccination in 2015, with only symptom being a sore arm at injection site. That was expected by the patient and hoped for with the SHINGRIX. The 2nd dose was scheduled in the reporting month, and might be less of a reaction with the next one.
When RN administered dose, the liquid of the vaccine leaked out between needle and syringe and it is unclear how much of the vaccine client received.
Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022; Patient was administered vaccine after 30-day Use By Date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L21A) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hyperlipidemia and Glaucoma. Concomitant products included GABAPENTIN, LOVASTATIN and LISINOPRIL for an unknown indication.    On 20-Apr-2022 at 8:49 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2022 at 8:49 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered vaccine after 30-day Use By Date) and PRODUCT STORAGE ERROR (Patient received a vaccine past the 30 day storage on the refrigerator, initially stored on 25-Feb-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not had any allergies to food or medications. Patient did not had COVID-19 positive or negative preceding month of vaccination.  Total number of doses/vials was 36. Vial did not undergo any temperature excursions. Patient not experienced any side effects yet.  No treatment information was provided.
light headed, but states feeling better.  advised to keep on drinking her water.  V/S within normal limits.  will continue to monitor
about 20 minutes after getting my flu and phnemonia shot, I experienced numbness on the left side of my face.  My eye and cheek are totally numb, and a little numbness on the right cheek and eye.  Also bad headache, and nausea.
I am pregnant, due February 19th. No other complications before or after this event. For two days after receiving this injection, I felt strong chest pains. At my routine ObGyn appointment on the 30th, the midwife figured the pains were caused by heartburn and said to monitor them. I have never felt heartburn that felt the same way other than after the vaccine, and it has not returned once it subsided.
Developed terrible itchiness, then significant sensitivity, then pain and rashes on the right thigh. This was diagnosed as shingles, which has lasted several weeks and is still continuing. Treatment has included a course of Prednisone.
A non-serious spontaneous report of administration of partial dose was received from a health professional concerning a six-year-old female patient. Neither patient history nor concomitant medication have been reported for this patient. On 22-Feb-2011, the patient received FLUMIST. While receiving FLUMIST in first nostril, the patient moved her head and did not get full dose. There were no problems while administrating FLUMIST in the second nostril. 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.
A week after second shot I experienced extreme lowe back pain, then tingling, then numbness in left foot moving up leg along nerve pathway. For 2 months I struggled to walk and still have nerve weakness along same nerve pathway on left foot/ leg.  I have now what feels like arthritis in lower back especially but in general as well.
vial stored in the fridge greater than 12 hours post puncture; Booster dose given  greater than 12 hr post puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Booster dose given  greater than 12 hr post puncture) and PRODUCT STORAGE ERROR (vial stored in the fridge greater than 12 hours post puncture) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007J21-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer COVID19 Vaccine (First dose) on 10-Sep-2021 and Pfizer COVID19 Vaccine (Second dose) on 01-Oct-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID19 Vaccine and Pfizer COVID19 Vaccine.    On 01-Apr-2022 at 9:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Booster dose given  greater than 12 hr post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vial stored in the fridge greater than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Booster dose given  greater than 12 hr post puncture) and PRODUCT STORAGE ERROR (vial stored in the fridge greater than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was provided.  Date the vial was initially stored in the refrigerator was 31-Mar-2022. Date and time vial was first punctured was on 31-Mar-2022 at 5 PM. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursion. Total amount of time the vial was exposed to room temperature range (8 degree Celsius to 25 degree Celsius) was no more than 16 minutes, only to draw out doses.   No treatment medications was provided.
This spontaneous report as received from a healthcare provider refers to a patient of unknown age and gender. No medical history and concurrent conditions were reported. On 18-FEB-2016 the patient was vaccinated with improperly stored oral ROTATEQ vial, (lot # K010224, expiry date 13-MAY-2016) (dosing regimen, frequency and route unknown). No concomitant medications were reported. It was reported that the oral ROTATEQ experienced a temperature of 48 degree Fahrenheit for a 9 hours time fame. It was also reported that there was no previous temperature excursion. It was also reported that the healthcare provider did not call to report because of a data logger. It was also reported that the oral ROTATEQ that was improperly stored was administered. No adverse effects were reported. The action taken with the therapy with oral ROTATEQ was unknown. The outcome of the events was unknown. There was no product quality complaint reported. It was also reported that GARDASIL and GARDASIL 9 had appeared on the product list as temperature stability questions were asked, however no doses of the improperly stored GARDASIL and GARDASIL 9 were administered. Additional information has been requested.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; 190 patients (9 different lot numbers) received a vaccine past the beyond used by date; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date), PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (no adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and PRODUCT STORAGE ERROR (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    Concomitant products were not provided. Unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Treatment medication were not reported. This case was for the 18th patient out of 190 reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Dizziness , Nausea and vomiting of clear gastric contents. Numbness in bilateral arms and hands. BP- 126/90 : 126/76: 128/72 readings in 5-10 minute increments. O2 saturations-97%-100% Resp-16-20 Pulse 120;128;147;119;111 (tachycardia) Treatment: Cool compress to head and neck areas. Positioned in supine. S/I to use V-Safe app. reportable signs to health care provider. With next dose avoid use of calanoids 24-48 hours before vaccine
Tingling and warm/heated sensations randomly on face, head, arm and leg and some redness. This started shortly after shot and continuing even through the next day (currently) but seems to be lessoning in severity.
patient confused.  thought he needed Shingrix vaccination.  Completed the series 5 years ago.  got shot #3 10-17-2023 no complications
Reaction was itchy; Hives; This case was reported by a consumer via call center representative and described the occurrence of hives in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Fluzone (On 4th September 2019, received Fluzone 0.5 ml high dose 2019-2020, manufactured by Sanofi).   On 22nd September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 22nd September 2019, couple of hours after receiving Shingrix, the patient experienced hives. On an unknown date, the patient experienced pruritus. On an unknown date, the outcome of the hives and pruritus were recovering/resolving.   It was unknown if the reporter considered the hives and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received dose of Singrix in the left arm. Approximately couple hours after vaccination, the patient had 1 small hive appeared around the area of injection and then spread about 5 inches on arm and continued to spread around arm from the front to the side of arm. The patient woke up the following morning and discovered noticeably more hives and then reports several little hives combined to form one large hive. It was localized reaction to upper arm. The patient reported that, the hives was itchy. The reporter stated that, reaction was slowly going away and that it was not as itchy. The patient stated that, simillar reaction occurred with Fluzone High Dose 2019-202 0.5 mL manufactured by Sanofi that was administered on 4th September 2019. The reporter wanted to compare and contrast ingredients in Shingrix and flu vaccine. The reporter did not consent to follow up.
Pain, redness, swelling, tender to touch from acromian process of left deltoid radiating down 2/3 of left arm towards elbow. Continued to spread.
w/in 48hr of vax pt exp episode of staring followed by eyes rolling then a dec level of responsiveness which resolved in less than 1min;p/3 such episodes pt brought in for eval 22DEC94;dx partial sz disorder/infantile spasms;
This spontaneous report has been received from a nurse practitioner regarding a patient of unknown age or gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On an unknown date, the patient was vaccinated VARIVAX dose 1, (dose, lot # and expiry date unknown). On 08-JUN-2012, patient received improperly stored VARIVAX dose 2, from lot # 671861/1907AA expiry date: 05-DEC-2013. No adverse effects were reported. The reporter stated that inconsistencies in storage temperature were identified on extensive review and records. The reporter stated that vaccine was not thawed. The nurse practitioner reported that there was insufficient date to provide 100 percent assurance on vaccine stability. This is one of the several reports received from the same reporter. Additional information has been requested.
March 30th at 1:00 fever 100.4, headache, backache, twitching muscles arms and legs, fatigue, sore hot arm,  I still have twitching in my arms and legs, still pain in injection site along with what I call a burning sensation. Lower back pain. Some times numbness in fingers
Three days post vax, pt developed a rash on the dorsum of her hands and arms.
This is a spontaneous report from a contactable consumer. A 74-year-old male patient received PREVNAR 13 (lot number and expiration date were not recovered) via an unspecified route of administration on 19Feb2019 at single dose for immunization and pneumococcal vaccine (PNEUMOCOCCAL POLYSACCHARIDE VACCINE, 23-VALENT), via an unspecified route of administration on 19Feb2019 at single dose for recommended immunization for his age. Medical history included PE (pulmonary embolism), high blood pressure, cholesterol lower and A fib (atrial fibrillation).  Concomitant medication included apixaban (ELIQUIS), diltiazem (CARDIZEM), rosuvastatin calcium (CRESTOR) and metoprolol succinate (TOPROL). The patient experienced a lot of pain and swelling at injection site, felt like he could not get warm, had chills and was shaking, all on on 19Feb2019. The outcome of felt like he could not get warm, had chills and was shaking was recovered on 20Feb2019 and other events recovered on an unspecified date. Information on the batch number has been requested.
Pt received 2nd dose in series 9/10/21 and felt drowsy that day. On 9/11/21 patient reported lying on stomach all day and development of sharp chest pain covering his whole chest that lasted throughout the day. On 9/12 the patient was no longer experiencing chest pain, but experiencing profuse sweating. On 9/13 the patient awoke with headache in the back of the head and back of teeth, chest discomfort, and feeling of heart skipping beats. Later that day he reported to an urgent care and was referred to the local hospital. At the hospital he presented with non-radiating midsternal constant stabbing pain that worsens when taking breaths. Patient admitted for close cardiac monitoring:  Cardiology consult, placed on continuous telemetry monitoring and started on aspirin, colchicine, and supportive therapy.
Received his shot and was sitting for ~5 minutes when he started to feel dizzy and nauseated. He stood up to say something to a cashier and while the pharmacist was walking out to check on him, his vision started to blur and he fell. He hit the plexiglass around our counter and then ended up sitting on the floor. He did not hit his head on the floor, and he was conscious and trying to get up when I reached him. We moved him into our immunization room, and had him lay down. Within about 5 minutes, he started to feel much better and was able to sit up and eat some crackers and drink some juice. He is getting a ride home and will relax for the rest of the evening.
This spontaneous report as received from a medical assistant refers to unknown patients of unknown age and gender. The patient's pertinent medical history, current conditions and concomitant medications were not reported. On an unknown date the patients were vaccinated with GARDASIL (dosing details were not reported) which had undergone a temperature excursion for 51.7 degree Fahrenheit for 20 hours (incorrect product storage). No adverse effects were reported. There was no product quality complaint involved. This is one of the several reports received from the same reporter. Additional information has been requested.
My 2 year old daughter has in the past year and a half had 13+ seizures. They have all been under different circumstances (some febrile, some trauma based, some brought on by nothing) and the only common denominator is the presence of a vaccination 2-3 days prior to all her seizures. We have been reassured numerous times that they are not correlated because the contents of the vaccine have nothing to do with seizures or the persistent vomiting and diarrhea she has also had. Yet, we are currently in the ER again due to 6 seizures in a single 24hr period; this isn?t the first time either. Today she was given Kepra (anti-seizing medication) in case she might have eppilepsy and roughly 30 min after that, she had another seizure, followed by another after we were admitted into the ER. Again, the only common denominators are the presence of vaccines, even though every medical professional has told us it's unrelated.
went home & slept p/vax; woke up crying 2 hrs later-cried non-stop for 5 hrs; no way to comfort-also had whelps on face;
unusual heart Rhythm.  captured on my loop recorder. early heartbeat.  symptoms-,  "fluttering" sensation in chest.  tiredness
Patient states after waiting 30 minutes after receiving vaccine she start to experience a headache and tingling to her lips. Patient states did is how she feels when she is about to have a reaction. APRN notified and informed LPN Nurse, to administer Diphenhydramine 25 mg capsule PO and to observe patient for 30 minutes more. After observing patient for 30 minutes, patient states tingling to lips subsided and only have a slight headache but is feeling better and is ok. APRN discharged patient and to follow up if needed. Patient verbalized understanding.
No additional adverse effect reported; vaccine that underwent a temperature excursion was administered; Information has been received from a medical assistant concerning a patient of unknown age and gender. There was no information regarding the patient's pertinent medical history, concomitant medications, or drug reactions/allergies.    It was reported that hepatitis a vaccine, inactivated (VAQTA) (lot # T013205, expiration date was reported as 02-DEC-2021 but upon internal validation established as 03-DEC-2021; lot # T023913, expiration date was reported as 30-MAR-2022 but upon internal validation established as 31-MAR-2022; lot # T018229, expiration date was reported as 13-DEC-2021 but upon internal validation established as 14-DEC-2021) underwent a temperature excursion. On 11-JUN-2021, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) (dose and route were not reported) for prophylaxis. Information for which lots were given to patient not provided. The vaccine was exposed the temperature excursion above 46 Fahrenheit degrees (47.2 Fahrenheit degrees) for 52 minutes (product storage error). The data logger was involved. There was no previous temperature excursion. No adverse effects were reported.  This is one of several reports received from the same reporter. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013205; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability; Sender's Comments:  US-009507513-2106USA004356:
A non-serious spontaneous report of administration of expired FLUMIST was received from a nurse concerning a 34-year-old male. Neither medical history nor concomitant medications were reported. On 26-Jan-2009, the patient received expired FLUMIST vaccine. The vaccine had an expiration date of 11-Jan-2009. As of 18-Mar-2009, there was no adverse event associated with this medication error; therefore, treatment and reporter/sponsor causality assessments are not applicable, and the event is considered resolved. Based on the results of the investigation, the root cause for the medication errors were caused by 1) customers not discarding product from previous season and 2) product expiring during the peak of flu season resulting in some medication errors that occurred shortly after the product expired. Follow-up information was received on 12-May-2009: Product Complaint Investigation results.
pt exp pain on bottom of feet & palms & in  lower back;body aches, leg cramps;idiopathic peripheral polyneuropathy perdominantly sensory;? anxiety vs MS;puffiness in feet, muscle sapsms;knees rubbery & hot, anxiety arthralgia, RA;arthritis
3 year old wwc. I gave pf flu on pt's 3rd birthday and should have given the adult flu. I notified pt's mom and she will bring the patient in to have adult flu given.
Grandmother brought child to clinic 6/19/07.  Child has a red swollen left arm.  Grandmother was instructed to use cool wash cloth on the swollen area, tylenol or motrin prn for discomfort, monitor for fever and if patient has increased symptoms to bring child to urgent care. "After the Shots" form also given with instructions.
Severe muscle and joint pain, severe headache triggering migraine and vertigo symptoms. Dosed with Excedrine Migraine at 10 PM- self administered. Severe pain and headache continued unaffected by painkiller until afternoon next day (1:00 PM) with 2nd self-administered dose of Excedrine Migraine.  3rd day symptoms are only severe headache with sharp pain, triggering vertigo symptoms.