chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No additional AE. No side effects were noted.; HCP reported ROTATEQ was possibly administered after a temperature excursion. Dates of administration and patient demographics were unknown as caller was unsure if an administration occurred. Caller did not have any further clarifying details. No add; This non-valid spontaneous report was received from a medical assistant referring to an unknown number of patients of unknown age and gender. Information regarding the patients' pertinent medical history, drug allergies/reactions, or concomitant medications was not provided.  On an unspecified date, the patients were vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (dose, route of administration, vaccination scheme frequency, and anatomical location were not provided;  valid lot number W020326 with expiration date 17-OCT-2023). The administered dose of the vaccine experienced a temperature excursion 48 degrees Fahrenheit for 15 minutes. If a data logger was implied, it was not mentioned. There was no previous temperature excursion or adverse effect reported.  This case was considered non-valid due to the lack of patients identifiers.  Follow up information has been received from the medical assistant on 19-DEC-2022. This spontaneous report was regarding a 3-months-old male patient (2 months old according to patient's date of birth and administration of the dose, conflicting information). On 23-NOV-2022, the patient was administered improperly stored dose of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTAVIRUS) oral liquid orally as prophylaxis (previously mentioned) (strength, dose and scheme were not reported). The vaccine was administered by a trained Health care professional and was reported to be used according to the instruction leaflet. Additionally it was stated the temperature excursion did not occurred as a result of the reading from a Data Logger.
Lump on Arm near injection sight of 2nd Moderna Covid 19 vaccination that appeared approximately 30 days after 2nd injection.  While the arm does not feel like Covid Arm, each day it feels like I have had a shot given to me.
Information has been received from a registered nurse and a consumer concerning a 10 year old female who on 09-JUL-1998 was vaccinated with the first 0.5 ml dose of varicella virus vaccine live (Oka/Merck) (lot# 625047/1574E). On 04-OCT-2007 during follow-up for the patient's brother for a chicken pox outbreak (WAES# 0711USA03442), the parents reported that their daughter also developed a chicken pox outbreak, with less than 50 lesions (reported by nurse as varicella outbreak post vaccination with varicella virus vaccine live (Oka/Merck)). It was unknown if the patient had a fever. The nurse contacted the county health department for medical attention. Treatment was also unknown. Subsequently, the patient recovered quickly and completely. There was no product quality complaint. Follow-up information from the reporting registered nurse indicated that the 10 year old Hispanic female did not have a fever along with the rash onset of less than 50 lesions from a varicella outbreak. The patient was noted to be recovered before 02-NOV-2007. This is one of four reports from the same source. Additional information has been requested.
? 1st dose Pfizer on 05/01/21, 2nd on 05/27/21. Patient was only 15yrs old at the time of first dose but turned 16 on 06/17/21.   No adverse effects, just reporting patient's age at the time of their first dose
This spontaneous report has been received from a pharmacist via company representative refers to a 51 year old female patient. On 09-SEP-2014 the patient was vaccinated with ZOSTAVAX, subcutaneously (lot number K003599, expiry date 13-MAR-2015) for prevention of shingles. It was unknown if the patient received concomitant medications. On an unspecified date the patient experienced a large red area, 4x4 inches in size, at injection site receiving ZOSTAVAX. Patient sought medical attention. Patient was diagnosed with cellulitis by her health care provider (physician assistant), on an unknown date in September 2014. She was treated with unspecified antibiotics. No product quality complaint was involved. The outcome of cellulitis was unknown. The reporter's causality was unknown. Additional information has been requested.
5 hours after shot my heart began racing to 195 beats /minute with palpitations.  After about an hour of this I went to ER and had an EKG resulting in multiple PVCs that did not abate.
Waited several years to receive 2nd dose; shot flattened me 3 days; This non-serious case was reported by a consumer via call center representative and described the occurrence of malaise in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In APR-2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. In APR-2022, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Waited several years to receive 2nd dose). On an unknown date, the patient experienced malaise (Verbatim: shot flattened me 3 days).         Rechallenge with Shingrix was positive. The outcome of the malaise was recovered/resolved (duration 3 days) and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the malaise to be related to Shingrix and Shingrix.     It was unknown if the company considered the malaise to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 7-Mar-2023  The patient received the first dose and then waited several years to receive the second dose of Shingrix.  The patient gave him 4 stars because he was very professional easy to understand but the only thing was, he did not ask any questions other than when the patient got the shot and what where my name and address. The patient was not able to report that the shot flattened him/her for 3 days which was what it did the first one especially. The patient did not know the exact date of the first dose or the name of the facility.  The patient received the second dose of Shingrix later than the recommend interval, which led to lengthening of vaccine schedule. The reporter consented to follow-up.
fever to 105 (tymp) during noc p/vax; swelling @ site of inj; APAP for fever;
3 weeks after first vaccine had these symptoms: right arm, right side o Muscle that got vaccine o Shoulder o Throatdifficulty swallowing o Facehurt to touch my hair o Head--couldn't sleep on Rt side o Neck  And: cough, shortness of breath, sinusitis  I had an appointment with my NP the day after 2nd vaccine was due on 03/07.  I asked if I should take 2nd vaccine; she said yes.  So I had it on the same arm.  Since then, I have lost the use of my right hand. I'm a writer and have to type with one finger. A friend said it was a pinched nerve. Another one asked if I had done the Proprioceptive neuromuscular release for my neck.    Additional information for Item 18: to turn it on or off at night. Additional information for Item 18: 3 weeks after first vaccine had these symptoms: right arm, right side o Muscle that got vaccine o Shoulder o Throatdifficulty swallowing o Facehurt to touch my hair o Head--couldn't sleep on Rt side o Neck  And: cough, shortness of breath, sinusitis  I had an appointment with my NP the day after 2nd vaccine was due on 03/07.  I asked if I should take 2nd vaccine; she said yes.  So I had it on the same arm.  Since then, I have lost the use of my right hand. I'm a writer and have to type with one finger. A friend said it was a pinched nerve. Another one asked if I had done the Proprioceptive neuromuscular release for my neck.
3 1/2 hours, post vax, pt began having sweaty palms and dizziness and then hands became hot down to slightly hot feet. Slight nausea and stomach pains. Ate lunch at 12:30. Splotchy hands, she said. Reported to clinic at 15:15. Vitals; BP-110/80; Pulse-92; Temperature 97.5F. Seen by MD and given Benadryl and ibuprofen.
Breakthrough case admission after three vaccines Pfizer 3/23/21 Lot# EP6955;  Pfizer 4/12/21 Lot# Ew0162;  Pfizer 1/10/22 Lot# FL3197
I had a 101.4 fever the day after the shot. I also experienced respiratory distress that accommodated a pneumonia. It required treatment. On that following Sunday, I went to the ER  and I was kept in observation overnight. They let me go the next day. When Friday came along, I knew I had really bad pneumonia. I went to the clinic and they gave me a prescription for antibiotics. I had a fever for 9 days straight.
pt recvd vax & reported intense pain in area from shot rt deltoid starting @ about 330PM felt fine; some warmth to face; dizziness, ceiling spinning, did not become unconscious, face & arms became numb;
No adverse event; The last dose was December 2021. Did patient need to start it again or did patient get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (The last dose was December 2021. Did patient need to start it again or did patient get the second dose) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. ASKU) for COVID-19 prophylaxis.   No Medical History information was reported.    In December 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In December 2021, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (The last dose was December 2021. Did patient need to start it again or did patient get the second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (The last dose was December 2021. Did patient need to start it again or did patient get the second dose) 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 PRODUCT ADMINISTRATION INTERRUPTED (The last dose was December 2021. Did patient need to start it again or did patient get the second dose).    No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact
Pt recv vax on 12/29/98; on same day pt exp headache, diarrhea &weak (x3 days), unable to lift (a pillow),
Pt devel high fever p/24 hrs, 2 days p/immun had sz, in hosp for work up;
Day after vaccine around 2:30 p.m., started with some neck discomfort.  Next day fever of 103.8, feeling fatigued, and swollen lymph nodes of underarm, side and back of neck. Following days fever ranging from 100.4 to 102.8.  This morning fever of 101.3, swollen lymph nodes are still present and quite tender.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms and chills. On an unknown date, the outcome of the influenza-like symptoms and chills were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist did not have time to provide further information during call. This is 1 of the 4 cases reported by the same reporter.
Woke up feeling nauseous. Got up to walk to the restroom and became dizzy, passed-out and fell on my way to restroom. Remained on floor until dizziness subsided (maybe fell asleep for a little bit, unsure). When I got up I was no longer nauseous, so I went back to bed. I was also experienced a headache, fatigue (since injection), chills and body aches (started at approximately 10 pm). I experienced these symptoms for the first two shots, so wasn't concerned. I did not check blood pressure or temperature, I was really tired and only thought of that after I woke up this morning.
Dizziness, lightheadedness, brain fog (started roughly 2 hours after injection and lasted approximately 12 hours); sore arm (started roughly 2 hours after injection and is currently still sore 48 hours later); stomach cramping (started roughly 10 hours after injection and lasted roughly 36 hours)
This is a spontaneous report from a contactable consumer. The 74-year-old female consumer received PREVNAR 13 on 22May2018 at single dose for immunisation. Medical history included glaucoma. The concomitant medications were not reported. The consumer developed localized redness on arm at injection site. It was a little better but still red. She also reported blurred vision and "bubbly vision" in left eye since the shot. She reported blurred vision in both eyes but left eye was much worse. She also saw floaters; had sensitivity to bright light. When she went outside it's like someone poured a "shaker full of bubbles" in her left eye. She need to wear sunglasses outside and inside. She had difficulty reading and trouble walking. She was very concerned about losing her eyesight. She went to eye Doctor the day before for assessment. Her eye doctor said he's never seen so much inflammation in her eyes before. She stated blurriness and 'bubbles' appeared the next day and had not improved at all. She reported having allergies which she took allergy shots for. Outcome of the blurred vision much worse was not recovered, localized redness was recovering, other events was unknown.
On July 12, 2022, I started feeling flu-like symptoms. I took a COVID-19 test. The result was negative. Between July 12 and July 14, 2022, my temperature fluctuated between 100-degrees to 100.6-degrees. I was not feeling any better, so I took another COVID-19 test on July 14, 2022. The result was positive. On July 15, 2022, I contacted my doctor. They recommended I go to urgent care. I went to urgent care. They gave me another COVID-19 test. The result was positive. I felt like I might have a Urinary Tract Infection. They took a urine sample. The result was negative. I was contacted about the monoclonal antibody treatment. On July 19, 2022, they gave me bebtelovimab. My temperature came back down to normal ranges.
day 8 site size of golf ball; injection site swollen, red, and hot to touch; injection site swollen, red, and hot to touch; injection site swollen, red, and hot to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site swollen, red, and hot to touch), EXTENSIVE SWELLING OF VACCINATED LIMB (day 8 site size of golf ball), VACCINATION SITE SWELLING (injection site swollen, red, and hot to touch) and VACCINATION SITE ERYTHEMA (injection site swollen, red, and hot to touch) 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. In July 2021, the patient experienced VACCINATION SITE WARMTH (injection site swollen, red, and hot to touch), VACCINATION SITE SWELLING (injection site swollen, red, and hot to touch) and VACCINATION SITE ERYTHEMA (injection site swollen, red, and hot to touch). On 28-Jul-2021, the patient experienced EXTENSIVE SWELLING OF VACCINATED LIMB (day 8 site size of golf ball). At the time of the report, VACCINATION SITE WARMTH (injection site swollen, red, and hot to touch), EXTENSIVE SWELLING OF VACCINATED LIMB (day 8 site size of golf ball), VACCINATION SITE SWELLING (injection site swollen, red, and hot to touch) and VACCINATION SITE ERYTHEMA (injection site swollen, red, and hot to touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided. No treatment medication was provided.
pt recvd vax; 1-2 wks later devel vesicles that subsequently disappeared 1 wk later;exp pain on rt scapula & what appeared to be a localized patch of zoster;at time of rpt pt exp blanching of skin such as that seen in adult zoster;
shoulder pain; Initial information received on 10-Mar-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves adult patient (unknown demographic) who experienced shoulder pain (musculoskeletal pain), while he/she received vaccine INFLUENZA VACCINE.  Medical history, medical treatment, vaccination and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious shoulder pain (musculoskeletal pain) (unknown latency) following the administration of INFLUENZA VACCINE.  Other relevant tests were not reported.  Final diagnosis was musculoskeletal pain.   It was not reported if the patient received any corrective treatment.  On an unknown date, the outcome of the event was not reported.  Information on the batch number was requested.
Inappropriate Reconstitution Technique; Inappropriate Reconstitution Technique; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA934A, expiry date 30-JUN-2024) for prophylaxis.   On 29-JUN-2023, the patient received Menveo. On 29-JUN-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Inappropriate Reconstitution Technique) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date 30 Jun 2023: The nurse stated that patient was administered a dose of Menveo on 29th June 2023 that was reconstituted with a sterile diluent instead of the supplied liquid CYW-135 component. At the time of reporting, a repeat dose had not been administered. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. The patient was administered a dose of Menveo that was reconstituted with a sterile diluent instead of the supplied liquid CYW-135 component which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
allergy reaction; Initial information was regarding an unsolicited valid non serious case was received from a consumer/non-health care professional via Medical Information (Reference number- 00886495) and transmitted to Sanofi on 06-Dec-2021.  This case involves a one-years-old male patient who experienced allergy reaction (hypersensitivity), after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7336NA, expiry date unknown) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed non-serious allergy reaction (hypersensitivity) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the event.  At time of reporting, the outcome was unknown for the event.
R deltoid swelling and pain and redness about 2 hours after getting the vaccine.  No difficulty breathing or wheezing. No rashes. No itching.
Patient received the covid vaccine dose #2 on 01/21/2021.   On 1/22/21 afternoon  she started to have body aches, chills, fatigue.  On 1/23/21 she woke up feeling well, but a few hours later had "VERY bad abdominal" pain, mild diarrhea and mild vomiting. She had this acutely for 2 days (Jan 22 & 23) and then another day of pain and nausea. Today, 1/26 has minor pain but much better. Diarrhea, vomiting resolved by 1/25/2021.   Denies any fever, rash, any throat or respiratory symptoms.  Denies any dietary changes. No new medicine.
PATIENT IS A 4MOS OLD WHO PRESENTS FOR 4 MOS VACCINATIONS. PARENTS OPTED TO RECEIVE JEV ALONG WITH ROUTINE 4 MONTH VACCINES. ABOUT 2 -3 MINUTES POST VACCINATION, PARENTS WERE IN THE WAITING ROOM AND BROUGHT INFANT BACK TO ROOM STATING REDNESS AND PURPLE RASH.  RN ASSESSED AND GENERALIZED RASH TO BILATERAL LOWER EXTREMITIES; NOT RAISED. NO DYSPNEA NOTED. PATIENT WAS ESCORTED TO THE ACUTE CARE CLINIC FOR FURTHER ASSESSMENT BY PROVIDER.
About a minute after the shot. He fell off his seat on face. The pharmacy staff rushed to him. Gave him an epipen shot. Called 911. Put him back on his seat as he regained consciousness. Drenched in sweat, we fanned him kept talking to him to keep him awake as he was dosing off and coming back.  We did this until the emergency crew came and took over. He later went home with his dad after some time
Information has been received from a physician concerning a patient of unknown age and gender. The patient's medical history and current conditions were not reported. On 11-MAY-2015, the patient was vaccinated with an improperly stored dose of VARIVAX (Merck) (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Around 7 o?clock I woke up shaking and sweating, I felt like I was having a seizure. My arm also felt like it had been stabbed over and over again. This lasted for three hours
Information has been received from a health professional concerning a 5 year old male patient who on 11/10/99 was vaccinated with a dose of varicella virus vaccine live. Subsequently, on approximately 4/9/04, the patient developed breakthrough chicken pox with less than 50 lesions. Follow up information indicated that there was not a single report of adverse reaction following varicella vaccinations. The reporter indicated that 49 other patients developed breakthrough cases of chicken pox. No additional information is expected.