chrisvoncsefalvay/vaers-outcomes huggingface dataset:
patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion); This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) in a 47-year-old male patient 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) .25 milliliter. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) and POOR QUALITY PRODUCT ADMINISTERED (patients have been administered doses while the temperature excursion assessment was ongoing (possible temperature excursion)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that there had been no power outages that would have impacted the Moderna vaccine. However, the reporter reiterates that because her facility was unable to download the digital data logger, they would need to treat this issue as a temperature excursion. The data logger was unable to download for the months of Dec 2021, Jan 2022, and Feb 2022. It was reported that the patients have been administered doses while the temperature excursion assessment was ongoing and reported that no adverse reactions were reported by any patients.
Patient complained of hives, coughing, thickening of tongue, and elevated heart rate within 3 minutes of receiving vaccine. Patient was evaluated and sent to the emergency department via transport.
Hospitalized for bloody stool, emesis and irritability on 8/4/14. Trans to a second hospital on 8/5/14. IV fluids. Intussusception noted. Resolution with air contrast enema. Discharged on 8/6/14 feeding well and no further bloody stools.
This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis. Co-suspect products included HAV (Havrix) for prophylaxis, HBV (Engerix B) for prophylaxis, DTPa (Infanrix) for prophylaxis, dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis, Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On 11th November 2021, the patient received Boostrix, Havrix, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Boostrix, Havrix, Engerix B, Infanrix, Infanrix Pre-Filled Syringe Device, Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: The age at vaccination was not reported. The practice administrator reported temperature of 24.4 Fahrenheit, which patients having received the vaccinations after the temperature excursion, which led to incorrect storage of drug. The reporter consented to follow up.
UNSPECIFIED ADVERSE EVENT; This spontaneous report received from a patient concerned an elderly female. The patient's height, and weight were not reported. The patient's concurrent conditions included: serious lung cancer (2002), breast cancer (2007), heart condition and endometriosis, and other pre-existing medical conditions included: patient had history of fertility treatments for 8 years in 1960s. The patient was not pregnant at the time of reporting. The patient previously received covid-19 vaccine ad26.cov2.s (dose number in series: 1) (suspension for injection, route of administration was not reported, batch number: Unknown, and expiry: Unknown) dose was not reported, 1 total administered on 09-APR-2021 to left arm for prophylactic vaccination. Five days after vaccination with covid-19 vaccine ad26.cov2.s (dose number in series: 1), on 14-APR-2021, the patient began bleeding vaginally and she was not sure if it came out from feet or vaginal area. She called ambulance on morning of 14-APR-2021 and in the middle of night. She was not able to stand up. The patient had bleeding again on an unspecified date, was admitted to the hospital on 20-APR-2021, stayed with 4 doctors for 9 days and received a blood transfusion. After hospitalization, the patient also went to rehab center. The bleeding resolved after the hospital stay and patient had two transvaginal ultrasounds, the second being only a few weeks ago, with appearing normal results. The results of the first transvaginal ultrasound scan was not reported. The patient recovered from vaginal bleeding on an unspecified date in APR-2021. The patient received covid-19 vaccine ad26.cov2.s (dose number in series: 2) (suspension for injection, route of administration was not reported, batch number: Unknown, and expiry: Unknown) dose was not reported, 1 total administered on an unspecified date in DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, following vaccination with covid-19 vaccine ad26.cov2.s. (dose number in series: 2), the patient experienced unspecified adverse event, and was hospitalized (date unspecified). Duration of hospitalization was not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of unspecified adverse event was not reported. This report was serious (Hospitalization Caused / Prolonged). This case, involving the same patient was linked to 20210942041 (Dose number in series: 1).; Sender's Comments: V0:20211259260-COVID-19 VACCINE AD26.COV2.S-Unspecified adverse event. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
ON 3/28/2021 AT APPROXIMATELY 11:00 A.M.  PT WAS ON HER STATIONARY BIKE EXERCISING WHEN SHE HAD A SUDDEN ONSET HEADACHE WITH SHARP PAINS THAT WENT DOWN HER NECK. SHE BECAME LIGHTHEADED AND NAUSEATED. SHE CALLED EMS AND WAS TAKEN TO LOCAL HOSPITAL WHERE IT WAS FOUND BY CAT SCAN THAT SHE HAD AN ACUTE SUBARACHNOID HEMORRHAGE IN THE BASILAR CISTERNS. SHE WAS AIRLIFTED TO ANOTHER HOSPITAL WHERE SHE SPENT 8 DAYS BEFORE DISCHARGE HOME. SHE CONTINUES TO HAVE SOME NECK PAIN AND HEADACHES AS WELL AS DEPRESSION.
symptoms started 12-24-2021  and got worse each day forward   Shortness of breath, cough, tiredness, weakness, sore throat, headache, nausea,  muscle aches,  joint aches,  conjunctivitis, nasal congestion, chest congestion,
Sore arm, headache, stiff neck and nausea began on evening after mcv4 was administered.  Symptoms resolving on 7/14/05. Heating pad to affected arm and tylenol given for pain with relief.
This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's pertinent medical history, concomitant medications and drug reactions or allergies reported. On 20-OCT-2015, the patient was vaccinated with expired dose of M-M-R II, therapy type rHA (lot # J013131, expiration date 17-OCT-2015, dose, anatomical location and route of administration were not reported) second dose. No adverse events were reported. Additional information has been requested.
c/o itching & heat @ site of vax lt deltoid; no hives noted; some warmth to touch over inject site; denies further sx; devel SOB, mild dyspnea & cough;
Pain started 11-1-12. Pain presented even w/o movement of arm. Pain still exists 11-25-12 but now only with movement. Pt seen by MD 11-28-12. MD believes is tendonitis of rotator cuff. Was told to ice & use ibuprofen & to return to office if no relief.
(translated from Spanish by FV) pt continues to tremble, is dizzy, has involuntary movements, at times stares into space like in a trance.
Painful upper arm, then wrist, with redness, swelling, warmth-over a 9-10 day period, spread to the upper chest.
2nd dose of gardasil administered in check in room in left upper arm.  Allowed to go, walked around the corner to check out and my daughter's eyes rolled back in her head and she began falling backwards.  As she fell, her arms were drawn into her chest and her back was arched.  She hit the floor full force on the back of her head and her hands remained tensed and pulled to her chest and her eyes began moving back and forth rapidly and then went back into her head again.  Her pulse at this time was 62.  She was in a total state of confusion once she regained consciousness and was very listless.  A dr began asking her questions which she was unable to answer some of.  No one checked her pupils with light.  An ambulance was called from the hospital adjacent to the clinic and she was admitted to the ER.  For the first 30-45 min in the ER she cried uncontrollably from the pain and her mood took an agressive turn.  Her blood sugar was checked and an attempt to give her tylenol by mouth was made but she was combative and would not take it.  She was taken to have a CT scan and returned.  The CT came back normal and urine and blood were checked.  We were discharged with a diagnosis of vasovagal syncope.  My daughter had a seizure and not just a fainting spell.  I witnessed the drawing up of the arms and the eye movements.  I honestly thought she was dieing right there in from of me.  She is a VERY healthy child involved in sports with no history of fainting or seizures and none in our family.  As of today, she is still suffering from a severe headache and nausea so I would not be able to say she has recovered.
Received Tdap and PPD. Within 5 minutes felt dizzy nauseated pale. Emesis X 1. Recovered within 15 minutes no LOC.
No additional AE information provided; The patient was administered the first dose of GARDASIL 9, on 3/27/2017 and the second dose of GARDASIL 9, on 6/20/2017 and did  not return for her third dose of GARDASIL 9 in September of 2017; This spontaneous report has been received from a medical assistant, referring to a female patient of unknown age. Information about the patient's pertinent medical history, concurrent conditions, concomitant medications and, previous drug reactions or allergies were not provided.  On 27-MAR-2017, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), and on 20-JUN-2017, the patient received the second dose (lot number M037770 and expiration date 01-JUN-2019 for both vaccines); the third dose was given on 20-JAN-2020 (inappropriate schedule of product administration) (lot number and expiration date  not provided) for prophylaxis. Details about strength, route of administration and anatomical locations were not reported.  No additional adverse events were reported.
Pfizer-BioNtech COVID-19 Vaccin EUA-. Severe Dizziness, light- headed.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011J20A) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) 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.   This case was linked to (Patient Link).
Dizziness; nausea; dry mouth; felt hot; chest tightness; sour taste in mouth; rapid heart rate; tingling on same arm vaccinated (L arm); some numbness in same arm left arm; felt shaky; Blood pressure elevated; This is a spontaneous report from a contactable healthcare professional.  A 39-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number: EH9899), intramuscularly in the left arm on 17Dec2020 02:25 at a single dose for COVID-19 immunization.  The patient had no significant medical history and no concomitant medications. Other illnesses at the time of vaccination and up to one month prior was none. The patient had no allergies to medications, food or other products.  On 17Dec2020 02:32, the patient experienced dizziness, nausea, dry mouth, felt hot, chest tightness, sour taste in mouth, rapid heart rate, tingling on same arm vaccinated (L arm), some numbness in same arm left arm, felt shaky and blood pressure elevated.  The patient was taken to emergency department and oxygen was provided.  The patient underwent lab tests and procedures on 17Dec2020 which included blood pressure measurement: elevated and heart rate: rapid.  Therapeutic measures were taken as a result of the events as aforementioned.  The patient was observed and discharged to home after 40 min. The outcome of the events was recovered on 17Dec2020.
flushing, redness, right hand sign of face, ear and right arm 45 minutes post vaccine; took Benadryl; over the course of time, no worsening of symptoms; pt took another Benadryl on advice of visiting nurse about 4 hours after 1st dose
Left thigh severe local (leg) swelling and erythema with fine vesicles which eventually denuded central area rxn 24 -> 48 hours peaked.
From initial information received on June 06 2005 from a nurse regarding an adverse event, it was reported that an 18 year old female patient received her first dose of Menactra, lot number U1575AA, administered intra muscularly in an unspecified site on May 31 2005. Six days later, the patient developed a head and upper back tenderness. At the time of this report, the patient had not recovered from these events. From additional information received on July 07 2005 it was reported that that the patient received the Menactra vaccine in the left deltoid. The onset of the backache and headache was June 05 2005. The patient took Tylenol with no relief so she decided to stop taking the medication. Her discomfort lasted until June 09 2005, then she started feeling better. She recovered from these events. No further information is anticipated. This case is considered closed.
Moderate soreness in left shoulder until Sunday after vaccination on Thursday. Cramping of the neck and upper back region for 36 hours after vaccination.
Pt experienced redness and hard area at injection site. Warm compresses applied and pt given Benadryl with relief noted.
His eyes were swollen shut and watery, especially his left eye. He acted like he was in a lot of pain because he screamed all day if he wasn't napping. He was very lethargic. He wouldn't hold his head up for about 3-4 hours after the shot. He acted dizzy. He would not sit up. His whole left side was swollen.
This spontaneous report as received from a medical mssistant refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history or concomitant medications was provided. On an unknown date, the patient was vaccinated with dose of GARDASIL (dose, formulation and route of administration were not provided, lot number K011325, expiration date 08-APR-2017) for prophylaxis. According to a digital data logger measurements, the vaccine was improperly stored in the temperature of 35 degrees Fahrenheit on 16-FEB-2017 for 9 hours, on 21-FEB-2017 for 7 hours, and on 23 February (year unspecified) for 7 hours 30 minutes. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Injection site swollen; Injection site painful; Injection  site warm to touch; difficult to move  arm around; This is a spontaneous report from a contactable nurse, the patient. A 55-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the arm left on 25Mar2021 at 16:30 (age at the vaccination was 55-years-old) as a single dose for COVID-19 Immunisation. Medical history included controlled high blood pressure from an unspecified date. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: unknown) via an unspecified route of administration in the arm right on 04Mar2021 at 16:30 (age at the vaccination was 55-years-old) as a 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 had not been tested for COVID-19. Patient had no allergies to medications, food, or other products.  on 25Mar2021 at 04:45, the patient experienced vaccination site swelling, vaccination site pain, vaccination site warmth, and arm discomfort which sometimes which makes her difficult to move the arm around. Patient also stated ''Believe the administration may have been given subconsciously instead of intramuscular. Another 2nd dose of vaccine necessary due to possible improper site administration? Do vaccines improperly administered effective enough to provide immunity? Should she be concerned?''. Patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Clinical outcome of vaccination site swelling, vaccination site pain, vaccination site warmth, arm discomfort was not recovered at the time of reporting.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Rash on upper neck/jaw and cheeks, predominantly on the right side of my face, lasted for several hours. I've never experienced it before or since.
COVID-19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19) in a 13-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 antibody test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.  The patient came to visit their grandparents in Aug-2022, and while he was visiting, he developed a fever and just very sick. Both. The grandmother was not sure if patient had received Moderna Covid-19 vaccine, or he had Pfizer. The grandmother would check with her daughter.   This case was linked to US-MODERNATX, INC.-MOD-2023-746856.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-746856:Grandfather case
Patient received vaccination on Friday, October 19 and later that evening she began to have difficulty breathing that lasted into the next day and then stopped.
UNEXPECTED THERAPEUTIC EFFECT; MINOR ACHES AND PAIN; EAR ACHE; SPLEEN PAIN; HEARTBEATS SKIPPED; MITRAL VALVE PROLAPSE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN) dose was not reported, administered on 16-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced minor aches and pain. On MAY-2021, the subject experienced ear ache. On MAY-2021, the subject experienced spleen pain. On MAY-2021, the subject experienced heartbeats skipped. On MAY-2021, the subject experienced mitral valve prolapse. On an unspecified date, the subject experienced unexpected therapeutic effect. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from minor aches and pain, ear ache, spleen pain, heartbeats skipped, and mitral valve prolapse on MAY-2021, and was recovering from unexpected therapeutic effect. This report was non-serious.