chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling of the arm; itching at the injection site; redness of the arm; hardness as the injections site; arm soreness; warm feeling in her right arm; This spontaneous report was received from a consumer referring to herself, a 67-year-old female patient. Information regarding the patient's concurrent conditions, medical history, historical drugs and concomitant therapies was not provided.  On 17-SEP-2022 between 13:35 and 14:00, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in her right arm for prophylaxis (strength, lot #, expiry date, and route of administration were not provided). At approximately 16:00, the patient began experiencing swelling of the arm (vaccination site swelling), itching at the injection site (vaccination site pruritus), redness of the arm (vaccination site erythema), hardness at the injection site (vaccination site induration), arm soreness (vaccination site pain), and a warm feeling in her right arm (vaccination site warmth). The patient did not believe that these symptoms were getting worse. This was all the information that was given regarding this case. At the time of reporting, the patient had not recovered from the events (reported as "How long will these symptoms last?").  The causal relationship between the reported events and polyvalent (23-valent) (PNEUMOVAX23) was unknown.
BODY ACHES; SLIGHT FEVER; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 31-MAR-2021 at right arm for prophylactic vaccination. No concomitant medications were reported. On 01-APR-2021, the subject experienced body aches. On 01-APR-2021, the subject experienced slight fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the body aches and slight fever was not reported. This report was non-serious.
Rash at injection site beginning 8 days AFTER injection. Rash is down my right arm, beginning at injection site and travels below, but above elbow. Rash is red, warm to the touch, itching, slight burning, and slightly swollen.
Vision in my left eye went blurry 10 minutes after I received the shot in my left arm. It felt like my contact came out of my eye, but it hadn't. Constant blurriness happened for 2 days, and after that it began to decrease and was not consistent. It still happens 5-10 times per day where my vision will go blurry, only in my left eye 6 months later.
Information has been received from a physician referring to an unknown number of patients of unknown age and gender. Information regarding concomitant medication, medical history and drug reactions/allergies was not reported. On unknown dates, on or after 01-APR-2016, the patients were vaccinated with improperly stored doses of VARIVAX (lot # L024253 with expiration date 01-JUL-2017, lot # L024256 with expiration date 01-JUL-2017, lot # L001328 with expiration date 13-JAN-2017, lot # L016123 with expiration date 06-MAY-2017; dose and route were not reported). It was reported that the vaccine was improperly stored at 35.47 Fahrenheit for 314 hours and 15 minutes. There was no previous excursion and data logger was involved. No adverse effect was reported. This is one of two reports received from the same reporter. Follow up information has been received from the physician on 24-OCT-2016. On 24-OCT-2016, a call was placed to the physician. The call was received by another physician. The physician reported that she would have to research the request made for patient identifiers, lot number and expiration date and dates of vaccination. The correspondence details were reviewed with the physician, if information becomes available. Follow-up information was received on 09-Nov-2016 from an unspecified reporter, who provided the patient's demographics, and stated that the patient (of unknown age and gender) was vaccinated with an improperly stored dose of VARIVAX with lot number L001328 (expiration date 13-JAN-2017). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information is not expected, as follow ups requested to complete the case were received.
Patient was asleep and became chilled and began shivering for about an hour.   Finally shaking stopped.
7pm same day as vaccination -  developed extreme fatigue, the next morning (12/29)  continued with extreme fatigue and began lower body muscle aches, right arm very sore and difficult to perform normal activities. 12/30 back to normal- no fatigue, no muscle pain but slight pain at injection site.
Flush; Felt a tiny bit nauseous; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flush), NAUSEA (Felt a tiny bit nauseous) and FATIGUE (Fatigue) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. UNK) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced FLUSHING (Flush), NAUSEA (Felt a tiny bit nauseous) and FATIGUE (Fatigue). At the time of the report, FLUSHING (Flush), NAUSEA (Felt a tiny bit nauseous) and FATIGUE (Fatigue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Vaccine expired June 8th 2023 but was not removed appropriately from pharmacy by pharmacy tech. Administered by RN (no expiry date on vial) 8 days past expiration by accident.  No patients reported difficulties.
Modern COVID-19 Vaccine EUA Headache after 4 hrs FEVER - peaked after 24 hrs at 103.7. Brought down with cooling rags and removing blankets and taking Tylenol  Chills Muscle Aches   Lasted 36 hrs
Two hours after receiving vaccines, child was noticed to be shaking arms and legs and not responsive. Subsequently, she had many more of these episodes. Child currently being seen by Pediatric Neurologist and taking Tegretol.
On 4/23 I had a fever and body aches as predicted. On 4/24 I still had a fever and my left ear had swollen, was painful and red.  My nearby lymph nodes were also swollen and painful On 4/25 I still had the same symptoms and I went to urgent care.  The doctors there told me to head to the emergency room where I was finally diagnosed with chondritis of the ear.  I was given antibiotics and sent home.  Finally, after 48 hours on the antibiotics, my symptoms began to subside and I became better.
Breakthrough COVID-19 case with  Shortness of breath or difficulty breathing. Hospitalized 7/24/2021 for unknown duration, Hospitalized 09/02/2021 for unknown duration
Pt had seizure within 5 minutes, post vax, lasting about 30 seconds.
Information has been received from a physician concerning a 6-year-old female who on an unspecified date was vaccinated with a 0.5 mL second dose of VARIVAX. Subsequently the patient developed transverse myelitis. Unspecified medical attention was sought. No further information was provided. There was no product quality complaint involved. Follow-up information was received on 02-AUG-2007 via a telephone call. The physician reported that the patient's date of birth was 09-NOV-2000 and he did not know the relationship of the transverse myelitis to VARIVAX. Upon internal review the patient's transverse myelitis was determined to be an other important medical event. Additional information is not expected. This is one of several reports from the same source. 6/12/08-records received for DOS 6/14-7/3/07- DC DX: Transverse myelitis. Neuropathic pain. Neurogenic bowel and bladder. Asthma. Mild azotemia. Presented with fever, leg pain, arm pain, abdominal pain began 6/6/07-Previously diagnosed with strep throat. Inability to walk. PE: 2+ deep tendon reflexes symmetric in upper and lower extremities, bilateral clonus. Incontinent of bladder, bladder distention. Developed spasticity in ankles, neuropathic pain. Decreased sensation up to T4. At time of discharge to rehabilitation facility minimal abduction and adduction of both legs.
fever approx 100, rash across cheeks, severe joint arthralgias mostly in the knees, swelling in knees & shoulders;
exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 1-year-old female patient who received HAV (Havrix) (batch number PB5JA, expiry date 14-FEB-2025) for prophylaxis.   In JUN-2023, the patient received Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incorrect storage of drug (Verbatim: exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 3-AUG-2023 Nurse reported Havrix vaccines from lot number PB5JA exposed to a low temperature of 31.5 degrees Fahrenheit on 15Jun2023 was administered between 15Jun2023 and 21Jun2023.  Reporter did not have specific date of administration for each patient.  At the time of reporting, the dose has not been repeated. The Vaccine Administration Facility is the same as Primary Reporter. Consented to follow up. This is 1 of the 9 cases reported by the same reporter.; Sender's Comments:  US-GSK-US2023105916:same reporter US-GSK-US2023105921:same reporter US-GSK-US2023105918:same reporter US-GSK-US2023105925:same reporter US-GSK-US2023105928:same reporter US-GSK-US2023105926:same reporter US-GSK-US2023105923:same reporter US-GSK-US2023105917:same reporter
Sore left arm, chills, sore joints, cough, 102F fever, stomach, diarrhea, lost of appetite, needed to stay in bed for 3 days. Sore left eye. Symptoms subside by the 3rd day. Currently I only have sore left eye.
8/18/00; exposed to chickenpox, 7 to 10 days ago. Now has maculo-papular rash, runny nose. Younger sibling has same symptoms since was also exposed.
EUA sore arm, achy muscles, pain in foot, tiredness, lethargy, and nausea.
Unsure if this was related, but I developed bilateral arm and neck weakness just about a week after receiving the vaccine. I made an appointment with my PCP who did an autoimmune work up, which was negative. Within about 2-3 weeks the symptoms improved then fully resolved. About 10 days after my second dose of covid vaccine, I had the same symptoms which resolved within about a week.
12/5 rec'd chickenpox vaccine, 12:30 swelling in eyes noted, wheezing noted.  BP 118/88, P 96. 05cc epinephrine given sq Lt deltoid, 50mg benadryl IM/LD, 12:35 paramedics here,12:45 left via stretcher to Henderick Hlth System, follow up from mother 4/24/01 - in ER x 3hrs, observed no other problems.
pt recv vax 10SEP97 & 13AMY97 pt exp lymphadenopathy;
Patient reports traveling to a different state and signs of weakness and ataxia on both legs occurred around 10/12/18. Left arm below the injection site have few blotch bruising.
Pt states that after receiving 3rd Anthrax shot, a few weeks post vax he experienced a mild fever (a little over 100) and it remained for about 6 weeks. Pt states that after that time there were no symptoms. Approximately on 6/28/99, he experienced a fever, no energy, increased bowel movement and burning upon urination. On 7/1/99 he saw an MD and had some tests run. He states that the MD concluded that it was the flu and sent him home. On 7/3/99, the fever persisted and the pt went to the ER. The pt was given some medication and an IV, the fever then lowered and the MD sent him home. On 7/4/99 the symptoms returned and this time they admitted him and started running test on him. This time his temperature peaked at 104.5. The pt states on 7/8/99, he was transported to another Medical Center where they continued testing. Approximately on 7/12/99 the fever broke and two days later they sent him home. About a month later he went to see an MD about an unrelated issue and was told that he would be on a temporary waiver pending investigations. Pt states also between the 1st and 3rd of July, 1999, he was experiencing discolored urine which was found to be bile.
My symptoms began on Monday 5/30. Around 8am I was sneezing. I also had a runny nose, scratchy throat and cough. Then it progressed into more symptoms. I was exposed on 5/26. I wasn't feeling anything but I thought to test myself that following Sunday. It came back negative. Then due  the symptoms that started Monday I tested myself Tuesday and it came back negative. That Wednesday, I had a a bad productive cough, achiness, loss of taste and smell. I also had lower gastrointestinal upsets for a few days. I had a low grade fever of 99.5 - 100 degrees.
+ Superficial thrombus 9/21/21.  No personal or family history of thrombus in past.
right shoulder soreness for the first dose for 1-2 days.  left shoulder soreness after second dose, then approximately 8-10 hours later, I developed headache, neck ache, and by the morning, had skin sensitivity especially noticeable in touching my hair and genitals in the shower which was approximately 15 hours later. By 18 hours later my headache had worsened and i began to get light-headed. i drank tons of water and had no urination. I got hot and almost fainted. I had extreme uncontrollable shivering by 20 hours after injection. i nearly passed out at work. I also had nausea and burping.  By the next day(more than 24 hours after injection), I was completely fine.
Severe numbness, pain, and weakness in both arms, primarily the right arm, from fingertips to shoulders.  Pain was a white hot burning pain, fingers had limited mobility (I could barely hold a pen), and treatments since the end of May with wrist braces and medications including Tylenol, ibuprofen, and Lyrica have been ineffective.  Finger mobility has improved but the pain is still present to this day.
She tested positive to the virus and had been under quarentine for the pass 14 days; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (She tested positive to the virus and had been under quarentine for the pass 14 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) 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 an unknown date, the patient experienced SARS-COV-2 TEST POSITIVE (She tested positive to the virus and had been under quarentine for the pass 14 days). At the time of the report, SARS-COV-2 TEST POSITIVE (She tested positive to the virus and had been under quarentine for the pass 14 days) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: (Positive) Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Additional information received: Patient had declined further follow-up. Patient stated that she was doing fine currently.
Kinrix was given. this was his 5th dtap and his 4th ipv. Rash from head to toe within 5 minutes of injections. No local reaction in arms. no respiratory involvement . order given by Dr. to give 25 mg of liquid Benadryl. Rash starting fading within 10 to 15 minutes. dad said he had no problems at all after that.
pain in the injection site; feel sick in her body, arms, and legs; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Expiration date: Not reported), via an unspecified route of administration on 07Mar2021 07:30 1ST DOSE, SINGLE DOSE as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that she had pain in the injection site for 2-3 days, and 2 hours ago, she started to feel sick in her body, arms, and legs on an unknown date Mar2021. The patient was asking "Can I take Tylenol or Motrin for this? patient was seeking guidance on what to do for the side effects experienced. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Breakthrough case admission after three vaccines Moderna 3/16/21 Lot# 001B21A;  Moderna 4/13/21 Lot# 016B21A;  Moderna 8/18/21 Lot# 050C21A
Swelling starting one day (11/26/19) after administration of vaccine in the back left arm (where MMR was likely administered). Swelling continued up until now with little to no improvement and no resolution after ice and ibuprofen. Redness is also occurring.
None reported Narrative:  A 67yo male with history of Neoplasm of Head and Neck, Pneumonia, Pyothorax, Dysphagia, OSA, Per nursing Immunization Note: received Covid - 19 vaccine on March 6, 2021 at1345 without complications, per policy/protocol and was advised to stay at the facility for 15 minutes post vaccination. He was also provided with information regarding possible side effects and how to report ADRs Unable to find any documented ADR from the vaccine. Per provider's documentation, the patient had stage IVa Oropharyngeal Squamous Cell Carcinoma and was hospitalized in February of 2021 for aspiration Pneumonia/Bacterial Pneumonia and Empyema. A CTA Chest also showed multiple nodules in the lungs and a mass like lesion in the right Pulmonary fissure with concerns for possible new pulmonary malignancy Admin officer's documentation, post communicating with Medical Examiner ,indicated the patient passed away at home on March 8, 2021
she had the shingles vaccine but still had shingles; This spontaneous report was received from a consumer referring to their friend, a female patient of unknown age. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      On an unknown date, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) for prophylaxis, but at the reporting time, she still had shingles (vaccination failure).     The causality assessment was not provided.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA008576:
Burning in legs; Body feels heavy; Doctor did notice a little swelling in throat; Steady low fever hasn't gone away; Many side effects complete with chills; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning in legs), DISCOMFORT (Body feels heavy), PHARYNGEAL SWELLING (Doctor did notice a little swelling in throat), PYREXIA (Steady low fever hasn't gone away) and CHILLS (Many side effects complete with chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 24-Jun-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BURNING SENSATION (Burning in legs), DISCOMFORT (Body feels heavy), PHARYNGEAL SWELLING (Doctor did notice a little swelling in throat), PYREXIA (Steady low fever hasn't gone away) and CHILLS (Many side effects complete with chills). At the time of the report, BURNING SENSATION (Burning in legs), DISCOMFORT (Body feels heavy), PHARYNGEAL SWELLING (Doctor did notice a little swelling in throat), PYREXIA (Steady low fever hasn't gone away) and CHILLS (Many side effects complete with chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided.  On 24-JUN-2021 Thursday, patient had vaccine and went back to doctor on Tuesday. Doctor had noticed a little swelling on throat and gave him PII(32):AZhSxbiTvtSUG8K0iJLneHEnKB0BbXY= packet 4mg.  Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.
This spontaneous report as received from a nurse refers to roughly 20 unspecified patients of unknown age. On an unknown date, roughly 20 unspecified patients were vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) that reached 18.5 for 10 hours and 44 minutes. This range was outside of storage conditions in product insert; however, the reporter stated that their in house stability data could suppose those conditions mentioned above that the (Oka/Merck) VARIVAX was exposed to. No concomitant medication was reported. No adverse effects reported. No product quality complaint (PQC) was reported. The outcome of events was unknown. No further adverse information was available.   Follow up information (after previous telephone attempt to obtain follow-up information which has been unsuccessful) has been received from nurse concerning (Oka/Merck) VARIVAX temperature excursion and one patient (patient ID#70281) of unspecified age and gender who was vaccinated with (Oka/Merck) VARIVAX (injection, strength, dose, frequency, route of administration and indication were not provided) (lot # J012817, exp date: 10-OCT-2015) that reached 18.5 F for 10 hours and 44 minutes. This is one of several reports received from the same source. Additional information has been requested.
The vaccine was reconstituted using a sterile solution instead of the included MenCYW.; The vaccine was reconstituted using a sterile solution instead of the included MenCYW.; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 16-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 26th May 2022, the patient received Menveo. On 26th May 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.       Additional Information: GSK receipt date: 3-June-2022 Reporter's comment: The medical assistant reported that patient was administered Menveo was reconstituted using a sterile solution instead of the included MenCYW. The reporter consented to follow up. Additional Supportive Information: The patient received Menveo which was reconstituted using a sterile solution instead of the included MenCYW, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.