chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of arm numbness in a 18-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline). Concurrent medical conditions included acne. Concurrent medications included BENZAMYCIN and CETAPHIL soap. On 16 June 2011 at 12:45 the subject received 1st dose of CERVARIX at 0.5 ml in the left arm. On 16 June 2011, 5 minutes after vaccination with CERVARIX, the subject experienced left arm numbness, eyes rolled back, stiffness and body jerks. It was reported that the subject was given oxygen and was laid down and her symptoms resolved.
About 36 hours after the injection, I became lightheaded, along with diarrhea, general feeling of being out of whack.  It lasted about 20 hours.
A report was received from a health care professional on 12/1/03 concerning an unspecified number of vaccinees less than 4 years of age and of unknown sex who inadvertently received Fluvirin on approximately 11/17/03. On approximately 11/17/03 multiple vaccinees less than 4 years of age inadvertently received Fluvirin. At the time of the report no adverse events had been reported. There was insufficient information to determine the reporter's causality assessment. Follow up pending.
Day after vaccine about 3 pm got acute lt upper arm redness, pain, swelling, warmth pt seen 1/24 2d after vaccine a recheck 1/25/13.
she received tetanus shot and experienced allergic reaction; Initial information received on 12-Aug-2022 regarding an unsolicited valid serious case received from a consumer/non-hcp (healthcare professional).  This case involves an unknown age female patient who received tetanus shot and experienced allergic reaction after receiving vaccine TETANUS TOXOID and while treated with DUPILUMAB [DUPIXENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 22-Dec-2021, the patient started taking DUPIXENT (DUPILUMAB) Solution for injection 300 mg QOW (every other week) subcutaneous (lot - Unknown at this time) for moderate persistent asthma uncomplicated (Asthma). On an unknown date, the patient received a  dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious event "she received tetanus shot and experienced allergic reaction (drug hypersensitivity) (unknown latency) following  intake of TETANUS TOXOID and DUPILUMAB. It is unknown if the patient experienced any additional symptoms/events   Action taken with DUPILUMAB (DUPIXENT) was unknown. Action taken with TETANUS TOXOID (TETANUS TOXOID) was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.  Seriousness criteria: The patient was hospitalized for this event.; Sender's Comments: Sanofi Company Comment dated 18-AUG-2022: This case involves an unknown age female patient who received tetanus shot and experienced allergic reaction and hospitalized after receiving vaccine Tetanus toxoid and while treated with Dupilumab [Dupixent]. Further information regarding concurrent condition during vaccination, previous vaccination, concomitant medication and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information the role of the individual suspect vaccine cannot be assessed.
Received vaccines 2/24/10, developed fever in evening of 2/24/10.  Left arm swelling distal to injection site started today and fever continues (2/25/10).
6-8 inches in diameter erythema skin rash which was sore to the touch.
Mom reported at the 6 month check up he had a fever to 104 and twitching movements the same day of vaccinations.  She also reported that he still have some twitching movements.
Low grade fever-99.6, chills, muscle aches, fatigue, 11 hours after vaccination.
On 11/24/2009 in the evening patient bumped his right hip on the dining room table and developed a large bruise.  Two days later his parents noted red spots on his trunk and extremities and took him to the Emergency Room.  He had petechiae and a platelet level of 3000.  He was transfered to another Emergency Room.
11/1/2021 Temp 99; headache. Right sinus and ears clogged, postnasal drip, malaise, no energy. 11/1 Augmentin prescribed by PCP. Previous headache right sinus infection, malaise, no energy after 2nd COVID injection. 4/9 Augmentin prescribed by PCP.
Patient experienced swelling and redness on right arm the day after the injection 9/15/2020 and the red area on her arm continued to grow.
Vaccine 4/16/18. Fever, croupy cough, and seizure (febrile seizure in pt with h/o seizures) on 4/17/18. Eval at ED.
Per employee/patient, she developed a mild headache, felt "warm & shaky" & had difficulty concentrating beginning about 1 hour after her vaccination. Symptoms continued to worsen over the next hour. At 2:20 pm she called the Employee Health Clinic; the Employee health RN went to Employee's worksite. Employee was flushed & visibly shaking; when she attempted to stand, her legs gave way & she was assisted back into her chair. Rapid Response team called; moved into treatment room. 2:40 HR= 122; BP= 135/76; O2 Sat.=98%. RR "rapid"; A&O. 2:44pm IV drip Normal saline in place. HR= 108; BP=126/88; O2Sat=100%.  2:46pm Benadryl 25 mg IV given. 2:51 pm EMS arrived & assumed care. Taken to Emergency Dept. by EMS.
Approx. 1-1.5wks after receiving vacs, patient developed hives on trunk and extremities. Pt took BENADRYL ATC for 2-3 days. Hives were itchy, red, raised, golf ball sized. Denies any other symptoms.
Patient was given the first dose of SHINGRIX at 4pm on 2/12/18. Upon a follow up call she stated about 22 hrs after the injection the skin on her neck and shoulders was irritated. It hurt to have clothing or bedding touch her skin. This lasted for 3 days. On the forth day she has a band of a streaky, red rash where the shot was given. She stated as of 2/19 her arm is still sore but the rash and sore skin is gone.
This spontaneous report was received from a licensed practical nurse and refers to a 4 month old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 10-OCT-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L046319, expiration date: 28-SEP-2017, dose was not reported), orally. No symptoms were reported. Administered vaccine experienced the temperature excursion of 32 degrees Fahrenheit for 15 minutes and 31 degrees Fahrenheit for 15 minutes. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1608USA012908: US-009507513-1608USA012916: US-009507513-1608USA012794.
blinded right eye; eye infection; This spontaneous case was reported by a consumer and describes the occurrence of BLINDNESS UNILATERAL (blinded right eye) and EYE INFECTION (eye infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced BLINDNESS UNILATERAL (blinded right eye) (seriousness criterion medically significant) and EYE INFECTION (eye infection) (seriousness criterion medically significant). At the time of the report, BLINDNESS UNILATERAL (blinded right eye) and EYE INFECTION (eye infection) outcome was unknown.            Concomitant medication not provided by reporter.  Treatment information not provided by reporter.  Action taken with mRNA-1273 was not applicable.  Very limited information regarding these events have been provided at this time. No further information is expected.; Sender's Comments: Very limited information regarding these events have been provided at this time. No further information is expected.
congestive heart failure/fluid build up/could hardly breath; Anemic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE CONGESTIVE (congestive heart failure/fluid build up/could hardly breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (congestive heart failure/fluid build up/could hardly breath) (seriousness criterion medically significant) and ANAEMIA (Anemic). The patient was treated with FUROSEMIDE (LASIX [FUROSEMIDE]) for Congestive heart failure, at an unspecified dose and frequency. At the time of the report, CARDIAC FAILURE CONGESTIVE (congestive heart failure/fluid build up/could hardly breath) and ANAEMIA (Anemic) outcome was unknown.            No concomitant medication was reported.  Patient had first shot in 05-Feb-2021 and second shot 05-Mar-2021. One month later patient was diagnosed with congestive heart failure. Patient went to hospital could not find anything wrong. Later found that she had fluid buildup that required two trips to the doctor to drain the fluid. She was given Lasix injections since it got so bad, she could hardly breath no other symptoms. She was also found to be anemic and given blood then sent to GI doctor. She thinks in second week in month of April, she was vaccinated in the right arm.  Company Comment: This case refers to a female patient of unknown age with no relevant medical history who experienced the unexpected event of Cardiac Failure Congestive which occurred on an unknown date after exposure to Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable as there was only one episode reported. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case refers to a female patient of unknown age with no relevant medical history who experienced the unexpected event of Cardiac Failure Congestive which occurred on an unknown date after exposure to Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable as there was only one episode reported. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.
area where shot was given was raised and red and very hard to touch. Pt was experiencing tingling in the spot as well
Within 6 hours I developed a headache, body aches and pains. That evening and into the next 2 days I had a fever (101), headache, shooting pains in all of the joints in which I have arthritis, and general body aches. Fever subsided on day 3, arthritic symptoms persist as do headaches and general malaise.
The pt screamed, became unconscious, could not wake him. He was extremely sleepy for 3 weeks, would fall asleep while nursing, eating, playing, etc. One week later he started convulsing after falling asleep and continues to do so.
VIAL WAS KEPT AT ROOM TEMPERATURE FOR 3 HOURS; POOR QUALITY VACCINE ADMINISTERED; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included allergy to sulfa. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, expiry: 07-AUG-2021) dose was not reported, administered on 21-JUN-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-JUN-2021, the subject experienced vial was kept at room temperature for 3 hours. On 21-JUN-2021, the subject experienced poor quality vaccine administered. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vial was kept at room temperature for 3 hours and poor quality vaccine administered was not reported. This report was non-serious.
12 hours after HPV #1 given, patient developed chest pain, wheezing and headache.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX in the upper arm. After receiving SHINGRIX, the patient experienced pain in upper arm. The patient was asking about medication to treat the same.
Patient received FLUMIST and ADACEL vaccines on 10/31. She developed severe arm pain and swelling in the left shoulder and arm a few hours after ADACEL vaccination. Symptom: Pain Start: 10/31/2006 Comment: In the left shoulder and left arm. Symptom: Erythema Start: 10/31/2006 Comment: At the left shoulder inoculation site. Symptom: Swelling Start: 10/31/2006 Comment: At the left shoulder inoculation site.
Sick; This non-serious case was reported by a physician via sales rep and described the occurrence of sickness in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 1 day after receiving Arexvy, the patient experienced sickness (Verbatim: Sick). The outcome of the sickness was not reported.   It was unknown if the reporter considered the sickness to be related to Arexvy.   It was unknown if the company considered the sickness to be related to Arexvy.   Additional Information: GSK Receipt Date: 30-OCT-2023 A healthcare professional (Hcp) reported that a patient got sick 1 day following rsv vaccine.  The hcp reported that the patient was positive for mono and it was a coincidence. The reporter did not consent to follow up.
I got flushed and hot, I got very nauseous.  I thought I was going to vomit and dizzy and laid on bathroom floor. I then got up and laid on bed and got headaches and chills.
Initial report received on 05 December 2007 from a physician. A five-year-old female, with no concurrent illnesses, but who had a history of milk allergy, and asthma, had received a fourth dose of Daptacel (lot number C2760AA) on 05 December 2007 ("or 04 December 2007"). The route and site of administration was "unknown." One hour post-vaccination, the patient developed swelling around the eye and a cough. She was treated with Benadryl and a nebulizer treatment. The patient subsequently was evaluated by an allergist on 05 December 2007, and at that time, the patient had no residual symptoms. No diagnostic tests or laboratory data were performed. At the time of this report, the patient had recovered.
Initial and follow-up information has been received from a medical assistant concerning a 12 month old male with no relevant medical history or allergies who on 18-JUL-2008, also reported as 10 days ago, was vaccinated with a dose of VARIVAX (Oka/Merck) (lot number 659457/1913U) subcutaneously in the left arm and a dose of MMR II (lot number 6503X) subcutaneously in the right arm. Concomitant therapy included a dose HAVRIX and a fourth dose of PREVNAR. Subsequently the patient developed vesicles on the body and several lesions on arm and leg. The patient also had a low grade fever (99-100 F). Unspecified medical attention was sought. Subsequently the patient recovered from the events. Additional information is not expected.
THE PATIENT WAS ADMINISTERED THE ADULT PFIZER VACCINE IN ERROR INSTEAD OF THE PEDIATRIC. PATIENT RECEIVED 0.3 ML OF THE PFIZER ADULT VACCINE INSTEAD OF THE 0.2ML OF THE PEDIATRIC PFIZER VACCINE
PATIENT FELT DIZZY AND FELL DOWN ABOUT 5 MINUTES AFTER GETTING VACCINE. HE DID NOT APPEAR TO LOSE CONSCIOUSNESS AT ANY TIME. HE HAD BREAKFAST ABOUT 4 HOURS BEFORE AND HAD AN EMPTY STOMACH (IN ORDER TO AVOID HIM THROWING UP). PHARMACIST HAD PATIENT LAY DOWN WITH FEET UP FOR 5 MINUTES, THEN SLOWLY MOVED UP TO SITTING WITH NO PROBLEM. WE GAVE HIM SOME APPLE JUICE. HE HAS A HISTORY OF FAINTING AND VOMITING AFTER IMMUNIZATIONS.
Started the day after receiving flu vaccine. Swelling in Right knee. Pain also in the effected knee.  By late evening very painful and walking difficulty. Notified Hospital Employee health nurse on 10/09/2020 and received this form to complete.  Knee swelling and pain was better in the morning two days after vaccine.  Third day was back to normal.
Possibly injected using 1/2 inch needle; Sore Arm; A spontaneous report was received from a PA concerning a 60 year old, female patient who experienced injection site pain after possible wrong technique in device usage process.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.    The patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the arm for prophylaxis of COVID-19 infection while using 1/2 inch needle.   Treatment information was not provided.    Action taken with mRNA-1273 in response to the event(s) was not provided. The outcome of the event, possible wrong technique in device usage process, was considered recovered/resolved on 05 Feb 2021.  The outcome of the event, sore arm, was not reported.; Reporter's Comments: This report refers to a case of wrong technique in device usage process for mRNA-1273 (lot unknown) with reported listed non-serious event of vaccination site pain.
Nauseated  Fatigue  Muscle soreness Really bad headache  Longer period
This spontaneous report as received from a Licensed Practical Nurse, referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not provided. On an unknown dates between 01-JAN-2017 and 16-MAY-2017, the patients were vaccinated with an incorrect storage doses of PNEUMOVAX 23 injection, lot# M032086 expiration date 09-OCT-2017 (strength, dose schedule and route were not provided) for prophylaxis. It was reported that on an unspecified date, the doses of PNEUMOVAX 23 were exposed to a temperature excursion between 32 and 35 Farenheit degrees for 1 hour. The call was placed because of a Data Logger. No adverse reaction was reported. Additional information has been requested.
After 30 receiving the Covid-19 vaccine, Patient developed symptoms: fatigue, lips numbing, metallic taste in mouth, difficulty breathing, nausea and dizziness.    I provided patient 2 tablets of Benadryl 25 mg (total 50 mg) and monitored patient.   I called 911 team when patient developed shortness of breath.  The ambulance team arrived 10 minutes later and determined that patient was not severely reacted.   Patient decided not to go to the ER and recovered after that.
Swollen lymph node in left axilla- visible/slightly tender (approx. 1 week) after 1st dose of vaccine
Headache, Arthralgia, Fever, right arm heaviness, chills Narrative:  Other Relevant History:
None immediate, but approx 2 months later = increasing fatigue, muscle ache, tremor, neurological decline (both cognitive and mood) malaise and ?felt lousy?, unmotivated. Months 2-5 = Increasing anxiety, depression, diminishing affect,  dramatically worse tremor, anxiety/dread.
Broke out in a red rash on face,neck, chest, part of stomach and right thigh within minutes of getting the vaccine. Doctor monitored and rash lighten up on its own. Rash was completely gone within 1 hour.
I developed a swollen lymph node in my right side neck just under lower jaw at rear. This presented itself as strong jaw pain like a bad cavity and soreness at the lymph node. I have a sore throat and have not been able to hardly chew or swallow without pain. This is still going on as of 3/3/21 but seems to be easing up a bit. I have a Dr. appointment on 2/9/21 to check it out.
No adverse event; Patient received first dose on 8-Jul-2023 and second dose on 23-Aug-2022, post 47 days; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 8-Jul-2023 and second dose on 23-Aug-2022, post 47 days) and NO ADVERSE EVENT (No adverse event) in an 18-month-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AR9237B) for COVID-19 prophylaxis.     Patient did not had acute illness at the time of vaccination and up to one month before. Patient had no chronic or ling lasting health conditions.  The patient's past medical history included COVID-19 (PCR test) on 28-Jan-2022.   On 08-Jul-2022 at 9:39 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 23-Aug-2022 at 9:23 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 23-Aug-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 8-Jul-2023 and second dose on 23-Aug-2022, post 47 days). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 8-Jul-2023 and second dose on 23-Aug-2022, post 47 days) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 8-Jul-2023 and second dose on 23-Aug-2022, post 47 days).    Concomitant medication was not provided.  Treatment information was not reported.   This case was linked to MOD-2023-713288 (Patient Link).
Hives within a few hours of receiving vaccination of hep B second dose. The hives slowly dissipated within 24 hours. Mother treated with Benadryl and watched for difficulty breathing. MD advised by phone not completing series.
At 15:20, vaccinations given; at 15:35, pt complained of feeling hot and woozy BP 179/108; P-84. Placed pt in supine position and elevated feet. Pt warm to touch. Cool towel applied to neck and head. At 15:45, BP 186/98; pt reported feeling better but legs numb. MD notified and pt sent to ER via husband. Dx'd with anxiety due to injections.
patient received a 5th dose of mrna vaccine in 8 months, after receiving covid 19 pfizer 2/11/2021 covid 19 pfizer 3/3/2021 covid 19 MODERNA 8/10/2021 covid 19 MODERNA 9/13/2021 and came in and received another Covid 19 pfizer 10/12/2021 (29days after Moderna series)
Patient started c/o  some itching behind ears.  No rash, no respiratory complaints.  Patient monitored for 45 minutes.  No change in overall condition.  Patient offered to be seen at a higher level of care (UC/ED) but declined.