chrisvoncsefalvay/vaers-outcomes huggingface dataset:
From healthcare staff: On 8/18/21 at around 9:10 am I gave a Moderna vaccine to patient. We had discussed before the vaccine that she had multiple allergies (mostly to medications) and with varying reactions (from hives to anaphylaxis). I told her she would need to wait 30 minutes after the vaccine based on her allergy history. Immediately following the vaccine the patient said she had a headache and started feeling like her breathing was shallow and her throat was closing in. I had staff call 911 at that time. The patient was still breathing on her own but it was labored. While staff was on the phone with 911 dispatch I gave the patient Benadryl. At around 9:20 the EMTs showed up. They said the patient's lungs were clear and her oxygen was fine. She was given the choice of going to the hospital or not. The patient chose to go to the hospital and was taken by ambulance.  Spoke to patient the next day and she was doing fine.  She has an appointment with her PCP to determine if she can receive the second dose of Moderna, and it will be done at a medical facility if she elects to receive it.
Intussusception R lower quadrant. 03/26/07-records received from facility for DOS 02/19-02/21/07-DC DX: Intussusception.  Vomiting, non-bilious however became bilious with small amounts of blood while in hospital. Several loose stools heme positive.
Pt was in the ER with coarse breath sounds bilaterally.  He also complained of chest pain during exertion.  He was found to be COVID positive.
This spontaneous report as received from a Nurse Practitioner via Company Representative refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # and route not reported). The nurse practitioner reported a patient, who had shingles 3 years ago, was seen in the office for an ear infection on an unspecified date. The patient was administered ZOSTAVAX on that date while in the office. Two days later, the patient was diagnosed with shingles in the ear and on the face. At the time of reporting, the outcome was unknown. The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Within 2 hours of vaccination:  soreness at injection site;   After 22 hours post-injection:  muscle soreness, fatigue, joint stiffness, headache
Patient was very anxious prior to the vaccine and kept repeating she was anxious. 5 mins in she reports subjective difficulty breathing and scratchy throat. EMS was called right away. She was alerted oriented and speaking sentences to us, no drooling, hives or no distress or wheezing on exam, vital signs were stable.   EMS arrived and administered 0.3 mg of epinephrine IM which helped her symptoms some.  She is still feeling somewhat short of breath but states that her throat swelling and tightness have improved.  She reports having a similar reaction when receiving the Tdap vaccination in the past.  She has some mild nausea but denies wheezing, rash, vomiting, diaphoresis.  She presents for further evaluation and treatment.
Pain and weakness radiating  from injection site in left deltoid down into elbow that started the morning after shot and has continued until present (3.5 weeks later). Patient doesn't recall any pain or discomfort at time of administration and only slight discomfort that evening before bed. Patient claim there is a constant ache and the injection area still hurts on touching it.  Patient describes pain is much like that from a pulled muscle but does not recall any injury.  Pain and discomfort improves with Tylenol and ibuprofen, ice and heat doesn't seem to help. Patient will follow up with there regular doctor if it doesn't improve.
preparing an IMOVAX RABIES vaccine and after mixing the vaccine and pulling it up the medicine came out the back of the syringe and went all over her and the counter with no reported adverse event; Initial information received on 11-Sep-2023 regarding an unsolicited valid non-serious case received from a other health professional (Nurse).  This case involves an unknown age female patient (medical assistant) who was preparing Rabies (HDC) vaccine [Imovax Rabies] and after mixing the vaccine and pulling it up the medicine came out the back of the syringe and went all over her and the counter with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient (medical assistant) was preparing Rabies (HDC) Vaccine suspension for injection (lot: V1E122M, Expiry date:10-Apr-2024) and after mixing the vaccine and pulling it up the medicine came out the back of the syringe and went all over her and the counter with no reported adverse event (occupational exposure to product) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.
I received my vaccine on 1/15/21 around 10 days later I started having very regular heart palpitations. On the morning of 1/27/21 the palpitations were worse and when I checked my pulse . I decided to take myself to the Emergency Room to be evaluated. In the ER I was found to be having PVC?s on my EKG and while on telemetry. I was released from the ER that day and told if they get worse to co e back, and to follow up with my PCP. I continued having Palpitations thru getting my 2nd vaccination which my PCP advised me to still get, and made me an appointment with a Cardiologist. By the time I saw the Cardiologist my palpitations had stopped, and I asked him if they could have been caused by the vaccine. He said he it very likely could have been but was unsure due to not enough data being out regarding the COVID vaccines.
Pt recvd 2nd dose of vax DEC91 & devel similar sx to a pt who had exp serum sickness & fascitis; no further details were provided;
past due for his second dose of vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (past due for his second dose of vaccine.) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (past due for his second dose of vaccine.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (past due for his second dose of vaccine.) outcome was unknown. Not Provided          No concomitant medications were provided by the reported. No Treatment History was provided by the reporter   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: TCR - No new information
Patient started getting a headache the night of getting the vaccination. At first, he had a headache that turned into body aches that the patient described as "feeling like I worked out for 8 hours straight".  He took Tylenol to help relieve these symptoms that gave him some relief. Symptoms lasted about 2-3 days.
Little Sore Arm/Arm just sore after 2nd vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Little Sore Arm/Arm just sore after 2nd vaccine) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 120L20A and 013L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 14-Feb-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced MYALGIA (Little Sore Arm/Arm just sore after 2nd vaccine). On 15-Feb-2021, MYALGIA (Little Sore Arm/Arm just sore after 2nd vaccine) had resolved. Not provided          Concomitant product use was not provided by the reporter.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-092047, -MODERNATX, INC.-MOD-2021-028972 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Non-significant follow up Received on 28-MAY-2021 contains ; Sender's Comments:  -MODERNATX, INC.-MOD-2021-092047:Daughters case -MODERNATX, INC.-MOD-2021-028972:Son in law's case-phone number is matching in this case with mothers case
VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins); This non-serious spontaneous report was received by partner (reference number 02197725) on 05-JUL-2022 and forwarded on 06-JUL-2022 from a consumer.    The causal relationship between Vaxelis and the reported event "multiple doses of VAXELIS administered since temperature excursion" was assessed as not applicable due to the nature of the event.    Further information is expected.  FOLLOW-UP INFORMATION was received by a partner on 01-AUG-2022 and forwarded on 03-AUG-2022, from a HCP. The case is maintained as non-serious.  The reporter confirmed that there were no Adverse Events following Vaxelis administration to the patient.  Due to the nature of the event, the causality between the event "VAXELIS administered since temperature excursion above 8.5° (10 mins)/Previous temperature excursion on 12-APR-22 above 8°C (10 mins)" and Vaxelis remained not applicable.  For reference purposes this case is linked to MCM-003724, MCM-003725, MCM-003726, MCM-003729, MCM-003734, MCM-003735, MCM-003737, MCM-003738, MCM-003739, MCM-003740, MCM-003741, MCM-003742, MCM-003743, MCM-003744, MCM-003747, MCM-003749, MCM-003751, MCM-003752, , MCM-003757, MCM-003759, MCM-003760, MCM-003761, MCM-003763, MCM-003766, MCM-003767, MCM-003769, MCM-003770, and MCM-003772, due to same reporter.  No further information is expected given that Vaxelis administration after temperature excursion cause no adverse events.
This spontaneous report was received from a consumer, who referred to her niece, a 20-year-old female patient. The patient's pertinent medical history, drug reactions and allergies were not reported. Concomitant therapies were not provided. On an unknown date in approximately 2011, reported as at age 13, the patient began vaccination (1st dose) with GARDASIL or GARDASIL 9 for prophylaxis (type of vaccine, strength, dose, route of administration and anatomical location were not reported) and she received full 3 doses (administration date for 2nd and 3rd dose were not provided). On an unknown date, the patient experienced as unspecified kidney disorder and was going to have a kidney transplant in the near future. As a part of pre-transplant process, she had a human papilloma virus test preformed with the positive result, on an unknown date. On 02-MAY-2018, the patient was informed by her physician that she was HPV positive. The outcome of the events was unknown. Causality assessment was not provided. Upon internal review, the event of unspecified kidney disorder requiring kidney transplantation was determined to be medically significant.
Swollen, red, and very hot. Originally 6-7 inches long and 3 inches wide but got much bigger. Went to ER and received IV antibiotics and Rx for Cephalexin - 500 mg. MD said it looked infected "cellulitis."
This spontaneous report was received from a registered nurse concerning an approximately 18 year old (at the time of the event occurred on second occasion) female patient with no pertinent medical history and no drug reactions or allergies. On 10-JUL-2012, the patient was vaccinated with the first dose of GARDASIL (lot number and expiry date reported as 0555AE and December 2014 respectively, dose unspecified), intramuscularly. On 07-AUG-2013, the patient was vaccinated with the second dose of GARDASIL (lot number and expiry date reported as J003727 and 07-NOV-2015 respectively, dose unspecified), intramuscularly. There were no concomitant medications. The patient experienced dizzy spells on both the occasions. The patient did not faint on either occasion. On an unknown date, the patient experienced dizzy spells after receiving the first dose of GARDASIL. On an unknown date, the patient recovered from dizzy spells. The patient experienced dizzy spells immediately after receiving the second dose of GARDASIL on 07-AUG-2013. The patient sought medical attention (call the reporting nurse). She was treated with increased fluids and salt. The patient was not recovered from dizzy spells occurred after receiving the second dose of GARDASIL. The relatedness for dizzy spells was unknown for GARDASIL. Additional information has been requested.
This spontaneous report was received from a healthcare worker professional referring to a patient of unknown age and gender. The patient's pertinent medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of ROTATEQ lot #L027070 with expiration date of 30-APR-2017 (dose number was not provided). The patient's concomitant medications were not reported. The healthcare worker stated, that ROTATEQ was exposed to a temperature excursion of 11.8 degrees C for a time frame of 2 hours and 35 minutes. It was called due to a data logger. Additionally it was stated, that the vaccine was not involved in previous temperature excursions. Furthermore, no adverse event was reported and no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry) in a 67-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 06-Jan-2021, 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,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (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 medication was reported.  No treatment medication was reported.   This case was linked to MOD-2021-395985 (Patient Link).
5 minutes post injection patient complained of slight headache, neck tenderness on left side.  BP 102/78, HR 51, RR 16 oxygen saturation 97% on room air. Instructed patient to increase hydration, rest. Reviewed adverse reaction with patient. Instructed patient to contact her physician if headache does not resolve or improve. Patient verbalized understanding.  Pt admits to being anxious about vaccine.
At and around the site of the shot:  red rash, blotchy and itchy.   It started a week or so after the shot.
I developed a large red circular rash that is hot, hard slightly uncomfortable.  I developed flue like symptoms that were like having the worst flu.  The next day, March 14,  I began to feel better but the pain has moved down the outside of my arm to the arm pit. It is uncomfortable to lift my left arm.  There is no rash or redness on my arm or arm pit.
Patient states that he had redness the "size of a quarter" since day of vaccination and on 08/15/2022 he noticed that the redness was  the "size of a dollar". He does not report any itching or pain at this time.
Moderate severe erythema/edema, warmth at site, temper to 106.7.  Went to ER 07/29/2005.
Myalgia, started with moderna dose 2, recovered somewhat then recurred  March 2, 2021 Physical therapy, steroid injection, analgesics.   Limited ADL and function. Scheduled appointment with rheumatologist on 8-6-21
Lots of soreness at the site of injection, some excessive sweating, large bump and slight bruise.  All symptoms started 8-10 hours after injection and continued for 48 hours.  Pain reduction medication (Motrin) was needed.
tiny spots on her arm where they were itchy, hurt, and red; tiny spots on her arm where they were itchy, hurt, and red.; arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), RASH ERYTHEMATOUS (tiny spots on her arm where they were itchy, hurt, and red) and PRURITUS (tiny spots on her arm where they were itchy, hurt, and red.) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Jan-2021, the patient received eleventh dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm was sore). On 30-Jan-2021, the patient experienced RASH ERYTHEMATOUS (tiny spots on her arm where they were itchy, hurt, and red) and PRURITUS (tiny spots on her arm where they were itchy, hurt, and red.). At the time of the report, PAIN IN EXTREMITY (arm was sore), RASH ERYTHEMATOUS (tiny spots on her arm where they were itchy, hurt, and red) and PRURITUS (tiny spots on her arm where they were itchy, hurt, and red.) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Patient presents to the ED on 9/21/2021 with fatigue and sob x 2 days.  He was started on oxygen (2L nasal cannula), dexamethasone, and remdesivir.  While hospitalized, he received 5 days of remdesivir, 7 days of dexamethasone, was weaned off oxygen, and discharged to home on 9/28/2021.
Initial report received from a healthcare professional on 13 December 2013. A child patient received PENTACEL and received HIB portion reconstituted with sterile water. (No information was provided regarding the patient). No adverse event was reported.
Her friends had stronger side effects with the second dose; People get body aches; People get joint pains; People get fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION COMPLICATION (Her friends had stronger side effects with the second dose), MYALGIA (People get body aches), ARTHRALGIA (People get joint pains) and PYREXIA (People get fever) 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 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 VACCINATION COMPLICATION (Her friends had stronger side effects with the second dose), MYALGIA (People get body aches), ARTHRALGIA (People get joint pains) and PYREXIA (People get fever). At the time of the report, VACCINATION COMPLICATION (Her friends had stronger side effects with the second dose), MYALGIA (People get body aches), ARTHRALGIA (People get joint pains) and PYREXIA (People get fever) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not reported. Treatment information was not reported.   Reporter did not allow further contact
Difficulty breathing. Swollen, bluish lips. Tongue swelling. Abdominal pains
Patient began feeling tired and weak. Body aches started about 30 minutes later. By the time I got him into the doctor's office he was very weak and complained of increasing pain all over. Doctor evaluated patient including asking him to touch his chin to his chest which he could not. Doctor stated due to his limited experience with Meningitis he would like him evaluated at a facility where they could better evaluate him and treat if necessary and referred us to a Hospital. We immediately drove to the hospital where he was evaluated. By the time we arrived at hospital patient needed support to walk into emergency room. He was triaged and taken to a room by wheelchair. Doctor swabbed him for strep and influenza. They adminstered fluids (saline) and a Norco (name?) patient responded to pain medication. He was also given antibiotics to take home. Patient did test positive for Step but since he didn't show signs of strep I was told he may be a carrier and will have false positive results. Influenza results were not communicated to parent.
Stiffness; This spontaneous case was reported by a physician and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Plaque psoriasis.    Concurrent medical conditions included Plaque psoriasis (Moderate to severe chronic).   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided. It was not known whether the patient was enrolled in a Covid-19 vaccine trial. The reporter's causality for co-suspect drug, adalimumab, was not provided.
felt a painful lump/mass under left arm (axillary) the day after receiving the vaccine 1/12/2021. I had an office visit on 1/14*2021 because I continue to have arm pit swelling with tenderness. I was alternating between motrin or Tylenol around the clock for several days and pain was relieved with pain medication. Dr. provided breast examination and determined could be lymph node swelling caused by the vaccine and we should wait 1 more week for further eval. She said if swelling still there would order an ultrasound, luckily at day 5 sunday 1/17/2021 I finally felt no more swelling or pain. no further exams needed and a few weeks later heard on the news this situation was becoming more common with vaccine administration.
Patient given HPV4 1st dose and MCV4 #2 within 10 minutes of receiving vaccines patient started with severe cramping rt calf muscle. Physician consulted immediately while still in medical group.
Day 1 fine. Day 2 Rash, red, hot to the touch,  lump, pain 2x1 inch diameter, Day 3 same but 3x2 inch diameter less pain but itching. Day 4  rash 4x5 inch diameter redness going away, warm to touch, itching