chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a medical assistant refers to a 13 year old patient of unknown gender. The patient's drug allergies and pertinent medical history was not reported. On 13-JUN-2014 the patient was vaccinated with first dose of GARDASIL (dose, frequency and route of administratin were not reported) (lot # J013324, expiry date: 12-FEB-2016) which was stored improperly. No adverse effects were noted. No product quality complaint ws reported for GARDASIL. This case is linked to 1407USA010956, 1407USA01902, 1407USA012903, 1407USA012904, 1407USA012905, 1407USA012906, 1407USA012907, 1407USA012908, 1407USA012909, 1407USA012910, 1407USA012911, 1407USA012912, 1407USA012913, 1407USA012914, 1407USA012915, 1407USA012916, 1407USA012917, 1407USA012918, 1407USA012919, 1407USA012920, 1407USA012921, 1407USA012922, 1407USA012923, 1407USA012924, 1407USA012925, 1407USA012926, 1407USA012927,  1407USA012929, 1407USA012930, 1407USA012931, 1407USA012932, 1407USA012933, 1407USA012934, 1407USA012935, 1407USA012936, 1407USA012937, 1407USA012938, 1407USA012939, 1407USA012940, 1407USA012941, 1407USA012942, 1407USA012943, 1407USA012944, 1407USA012945, 1407USA012946, 1407USA012947, 1407USA012948, 1407USA012949, 1407USA012950, 1407USA012951, 1407USA012952, 1407USA012953, 1407USA012954, 1407USA012955, 1407USA012956, 1407USA012957, 1407USA012958, 1407USA012959, 1407USA012960, 1407USA012961, 1407USA012962, 1407USA012963, 1407USA012964, 1407USA012965, 1407USA012966, 1407USA012967, 1407USA012968, 1407USA012969, 1407USA012970, 1407USA012971, 1407USA012972, 1407USA012973, 1407USA012974, 1407USA012975, 1407USA012976, 1407USA012977, 1407USA012978, 1407USA012979, 1407USA012980, 1407USA012981, 1407USA012982, 1407USA012983, 1407USA012984, 1407USA012985, 1407USA012986, 1407USA012987, 1407USA012988, 1407USA012989, 1407USA012990, 1407USA012991, 1407USA012992, 1407USA012993, 1407USA012994, 1407USA012995, 1407USA012996, 1407USA012997, 1407USA012998, 1407USA012999, 1407USA013000, 1407USA013013, and 1407USA013014 (same reporter link). Additional information has been requested.
System and local reaction. About 5 hours after injection site, very sore arm, red around injection site both lasting 36 hours. 12 hours after injection patient  got severe chills, severe body aches, fever of 101.2 for 2 hours, headache, extreme fatigue. All symptoms lasted about 36 hours. My shot was done on Wednesday morning and I had to call in sick to work Thursday and was not scheduled Friday.
Patient reported having a panic attack shortly after receiving the vaccine. He was noted to be perspiring  a lot as he remained seated on a chair. the attending nurse obtained his V/s - bp 127/78, rr 16, Hr 71, psox 98% RA, temp 94.8. Pt was offererd 451 mls of fluid and he drank all of it.He was encouraged to spend extra 15 mins for further observation and he obliged. At 1:26 pm he verbalized feeling well and ok and walked out of the building unassisted
Information has been received from a licensed clinical social worker referring to an unspecified number of patients of unknown ages and genders. The patients' medical history, concurrent condition and concomitant therapy were not reported. On unknown dates, the patients might have been administered improperly stored VAQTA injection (lot # M015290, expiration date 20-SEP-2017; dose and route were unknown). The vaccines were stored under temperature 11 Celsius degree for 17 days. There was no previous temperature excursion. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Vial was in the refrigerator for about 12 hours, 2 patients were injected with the same vaccine vial for their first dose; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) that was in the refrigerator for about 12 hours and 2 patients were injected with the same vaccine vial for their first dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 24 Dec 2020, the patient received their first of two planned doses of mRNA-intramuscularly for prophylaxis of COVID-19 infection.  On 23 Dec 2020, eight doses were used from a vaccine vial and was stored on an ICE cooler between patients. When finished for the day, the punctured vial was kept in the refrigerator under the recommended temperature range.   On 24 Dec 2020, after the vial was in the refrigerator for about 12 hours, two patients were injected with same vaccine vial for their first dose. No treatment information was reported.   Action taken with mRNA-1273 in response to the event was not reported.  The event, was in the refrigerator for about 12 hours and 2 patients were injected with the same vaccine vial for their first dose, was considered resolved on 24 Dec 2020.; Reporter's Comments: This report refers to a case of product storage error for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product storage error.; Sender's Comments:  US-MODERNATX, INC.-MOD-2020-001773:Same reporter, same source, different patient
I started feeling a headache and nausea coming on about 7:00pm. By 11pm, I had uncontrollable shivering, extremely cold, massive headache, stomach pain and continued nausea, along with body aches. My blood pressure got to 154/83. By midnight my heart rate was 120 beats per minutes. I took Tylenol, and a baby aspirin, as well as Pepto Bismol for nausea. I took a hot bath trying to stop the shivering. My heart rate was still over 100 when I woke up on Saturday Feb 13 at about 8am. By Saturday at 3pm, my blood pressure finally started to drop as well as the heart rate. 121/73, 86 bpm.  Currently, at 3:30pm I am still experiencing extreme discomfort in my stomach, and a mild headache. Pain continues at the injection site.   After the first dose of the vaccine on 1/14/21, the only symptom I experienced was a mild headache and a rash all over my back.
Large red hand print size area on the left upper arm . It felt like a sun burn .  I am not sure how long it was there . I found it when the sleve of my shirt was  rubbing  on the area. I saw the doctor two days after discovering  it.
right arm slight redness on 07/26- eased with moist heat. 07/30 am started with arm pain, splotchy redness from shoulder to elbow, slightly swollen itching. Cont. Tylenol and Benadryl and moist heat . Plan to PMD. 08/06/2002 called mom- completely recovered.
In the evening after his 5th dose of Anthrax vaccine, patient developed left-sided "cramping" chest pains not associated with activity, non-radiating.  He also developed left shoulder arthralgias and a "heat sensation" over his left scapula.  Patient experienced similar chest pains after his 4th Anthrax dose in September 2007 but did not associate them with the vaccine at the time.  He has no other history of chest pain.  The chest pains resolved spontaneously over several days to week.  EKG normal.
Petechiae - like rash suddenly appeared around his eyes and cheeks, not evident anywhere else. Temp 99.8 F. Denied itching, discomfort, vomiting, coughing, heavy lifting trauma. The following morning the rash was still present but faded. The rash was noted to be gone on 11/12/09.
Fever, Vomiting, Fainting, Speech Problems, Blurred Vision, Decreased Heart Rate, Trouble Walking and Standing.
Still have sore muscles (side effects); Bad head ache (side effects); This case was reported by a consumer via interactive digital media and described the occurrence of muscle soreness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced muscle soreness and headache. On an unknown date, the outcome of the muscle soreness and headache were not recovered/not resolved.   It was unknown if the reporter considered the muscle soreness and headache to be related to Shingles vaccine.     Additional Information: GSK receipt date: 10-Sep-2022 Reporter's comment: This case was reported by a patient via interactive digital media. Reporter stated that patient was at 4 days and still had sore muscles and bad headache. The reporter wanted to know how long would it last. Additional supportive information: The follow up would not possible as no contact details were available.
Soreness at injection state for 2 days then went away. Day 8 had blister like area which later turned very itchy. I went to occupational health at work. They game me hydrocortisone cream 1%.  1/9/2021 I woke up to swollen red arm, warm to the touch. Reddened area grew outside of pen marked area. Began having tachycardia and an increase in blood pressure and headache. I made an appointment with online doctor who said to monitor BP and if higher seek medical attention. Got off phone and felt dizzy. Took my blood pressure again and it was much higher so I went to the ER. ER determined it was reaction to vaccine
fever blister, body aches, h/a;lasted approx 5-6 days;
This spontaneous report as received from a nurse, refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with a dose of GARDASIL (dose, route, lot # and expiration date were not provided) that had been improperly stored. No adverse effects reported. This is one of two reports received from the same source. Additional information is not expected, because there was no consent to contact the reporter.
DID NOT COMPLETE IMMUNIZATION ONE WEEK PRIOR TO TRAVEL TO AN ENDEMIC AREA; This spontaneous case report (PVX2019-1853) was received from a pharmacist on 17-Jul-2019. It describes an adult female consumer who "did not complete immunization one week prior to travel to an endemic area" (PT: Inappropriate schedule of product administration), while being on oral Vivotif capsule (one dose every other day) for typhoid prophylaxis.  Case report: The consumer took the first dose of Vivotif on 16-Jul-2019. On 21-Jul-2019, she had a planned travel to endemic area and her last dose would be on 22-Jul-2019.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "missed the second dose" was considered as not applicable.
All over recurring hives. They come and go and are still continuing today. I have gone to the hospital twice and had blood work and other tests and no other reason for the hives can be found.
Received vaccine  12/30/20  with 2 days of  minimal pain at injection site.  On  1/2/21  I started with  cough and  and runny nose. Symptoms  worsened with body aches and I tested + Covid  on 1/4/21.  Treated w/abx,decaedron, and myoclonal infusion.  Have had prolonged recovery w/  Covid pneumonia and  exacerbation of asthma (CXR + for ground glass opacities).  Im still out of work due to cough and  SOB
2 MAJOR BREAST CANCER SURGERY; still not feeling well; second shot will potentially be greater than day 36/patient did not receive second shot on time due breast surgery; This spontaneous case was reported by a consumer and describes the occurrence of BREAST OPERATION (2 MAJOR BREAST CANCER SURGERY) 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.     Concurrent medical conditions included Breast cancer.    On 02-Apr-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 BREAST OPERATION (2 MAJOR BREAST CANCER SURGERY) (seriousness criterion hospitalization), MALAISE (still not feeling well) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot will potentially be greater than day 36/patient did not receive second shot on time due breast surgery). The patient was treated with Surgery for Breast operation. At the time of the report, BREAST OPERATION (2 MAJOR BREAST CANCER SURGERY), MALAISE (still not feeling well) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second shot will potentially be greater than day 36/patient did not receive second shot on time due breast surgery) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication and treatment information were not reported.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the event of Breast surgery as it is unlikely.   This case was linked to US-MODERNATX, INC.-MOD-2021-109590 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded except for the event of Breast surgery as it is unlikely. US-MODERNATX, INC.-MOD-2021-109590:
Sore arm after injection; This is a spontaneous report from a non-contactable pharmacist received via a Pfizer sales representative. A 32-year-old female patient received BNT162B2 (solution for injection, lot number/expiration date unknown) via an unspecified route of administration on her arm in Dec2020 at a single dose for immunisation. Medical history and concomitant medications were not reported. The patient experienced sore arm after injection in Dec2020. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
IT IS NOT AN ADVERSE EVENT.  Patient received bivalent booster dose without diluent.  Spoke with parent 40min and 2 hrs after event and no SE reported
Temp in the refrigerator was 19 degrees C for approx. 2 hrs. Action recalled client.
1st dose given 29Mar2021, 2nd dose given on 09May2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given 29Mar2021, 2nd dose given on 09May2021) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 018B21A) for COVID-19 vaccination.     Concurrent medical conditions included Psoriasis (Was diagnosed 10-15 years).  Concomitant products included RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Psoriasis.   On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-May-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given 29Mar2021, 2nd dose given on 09May2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose given 29Mar2021, 2nd dose given on 09May2021) outcome was unknown.      It was reported that patient has psoriasis (diagnosed 10-15 years) ago and said that was considered as an immunocompromised state. Patient denied any Covid-19 infection prior to and after getting the vaccine. No treatment details were reported.
My arm has been red, swollen, and sore since receiving the vaccine.  It has been three and one-half months since injection, and my arm is still red, swollen, and sore underneath injection site.
This case was reported by a healthcare professional and described the occurrence of fever in a 2-month-old male subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis adsorbed, hepatitis B recombinant and inactivated poliovirus vaccine combined (Pediarix) for prophylaxis. On 15 November 2006 the subject received 1st dose of Pediarix.  On 15 November 2006, the subject also received 1st dose of 7-valent pneumococcal conjugate vaccine (Prevnar), and 1st dose of Haemophilus influenzae type b vaccine (unspecified).  On 15 November 2006, less than one day after vaccination with Pediarix, the subject experienced a fever.  The subject was seen in the emergency room on an unspecified date on or after 15 November 2006 and on or before 17 November 2006.  Laboratory analyses performed while the subject was in the emergency room revealed pleocytosis.  The subject was hospitalized and the healthcare professional considered the events were clinically significant (or requiring intervention). The outcome of the events was not reported. (OMIC)
Sensation of chest tightness within 5 min after immunization with HEPA, HPV, TDAP. PPD test done also at same time. Symptoms persisted for 3 days until Albuterol was given. Symptoms not reported to office staff there in office - asked to stay in office for 15 minutes after shots were given.
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. Nurse reported that on an unknown date 30 improperly stored GARDASIL (0.5 ml, intramuscular, unknown dose number) doses have been administered to unspecified number of patients (patient demographic information unspecified). No adverse effects reported. No additional information provided. Additional information has been requested.
3-4 min after administration of Td vaccine Child had seizure activity that included incoherent, eyes rolled back in head, head, neck and torso arched backward, Both upper and lower extremity jerking motions, pallor.  No recollection of event after seizure activity, but did c/o of nausea.  No emesis, but BM after event-not incontinent.  Pt reported dizziness prior to "falling asleep spell".  Recovered completely.  VS/WNL, transported per mom to ED.
Information has been received from a health professional concerning a 14 year old female who was vaccinated with her second dose of Gardasil vaccine intramuscularly. The patient fainted and fell on the floor after receiving the second dose. The patient collapsed on the floor and possibly hit her head. The patient was taken to the ER and released after examination. The patient had a history of fainting following blood draws and the patient had not eaten prior to the vaccination. Subsequently, the patient recovered. Additional information was received and entered on 16-OCT-2007. On 10-SEP-2007, the patient experienced the above adverse events. Additional information has been requested.
Patient's wife called the next day and said he had been feeling ill and had a fever and bad body aches was concerned. We followed up with him about 4 days later and he said he was feeling much better. He had contacted his doctor who advised him to take otc pain relievers but I'm not sure if he actually visited the office.
Vomiting, high fever (104 Rectal), headache, pt seemed "out of it" per mother. Started through the night 7/14 to 7/15/09. Went to ER for Eval on 7/15/09.
(unknown route) unknown. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment medications were reported.  This is a case of product exposure during pregnancy with no associated adverse events (AEs) for this female patient of unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated adverse events (AEs) for this female patient of unknown age. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
Fever, chills, muscle aches, vomiting, headache, lightheaded, stomach pain,. Symptoms lasted 12 hours. I had a recurring headache after 1st dose of Moderna dated 01/25/21. I was given a CT scan in February.
Patient broke out in a rash on the back of both elbows and the back of both knees. She contacted her prescriber and was using hydrocortisone
Patient experienced vasovagal syncope after receiving the influenza vaccine.  It lasted a few seconds and patient regained consciousness.  A nurse practitioner then came to check patient's pulse & blood pressure.  She monitored him until his pulse and blood pressure stabilized and released him afterward.
Had no symptoms  until about 11pm on day of injection, when I began to feel pain in my right arm. Woke at approx. 4:15 am with chills, slight fever of 99.9, had a severe headache, muscle and joint aches. Woke again at approx. 9am with nausea and begin vomiting, as after the 1st injection it was a bright yellow bile substance with no food particles. Experienced all the stated symptoms until late morning on March 11th. Along with all the symptoms, I also had extramarital pain in my arm at injection site with a large swollen area around injection site which lasted through March 13th/am. It felt very much like a large knot. My symptoms have mostly ceased as of today, March 13th, however am feeling tired and fatigued.
Two days after my first vaccine, I experienced pain under my right arm and breast. I waited 4 weeks and the pain got worse. Ireceived an ultrasound and mammogram of the right axial and right breast to rule out any concern. I was seen by the radiologist and PA-C that reported no masses. PA-C prescribed Gabapentin for the pain. 100mg qd. I continue to take OTC meds for pain as well.
This spontaneous report as received from a pharmacist refers to a two unspecified patients of unknown age and gender. No pertinent medical history, drug reactions or allergies were reported. On 10-OCT-2014, the two unspecified patients were vaccinated with expired PNEUMOVAX23 (dose, dose number, route, anatomical location, lot number and expiration date were unspecified).  No adverse effects were known. Concomitant therapies were not reported.  Follow up information has been received from a pharmacist on 28-OCT-2014. This report concerning a female patient of an unknown age. On 10-OCT-2014, the patient was administered expired does of PNEUMOVAX23 lot number: J007786, expiration date: 25-SEP-2014. This is one of several reports received from the same reporter. Additional  information has been requested.
The main onset symptom was pain in left side chest under heart and was tender to touch. Pain increased went to ER and they ordered a CT and found a blood clot on the spleen. I was admitted to the hospital, I underwent lots of testing due to having diarrhea and serious disorientation. I had an IV for the entire week I was there with antibiotics and blood work daily. I did have something in my bloodwork that concerned them, they tried to grow sample but it didn't produce anything. They did tell me the blood clot was stable and prescribed me Eliquis blood thinner. The hematologist did find the blood work was a protein that he was not real concerned with but he stated I do need to stay on blood thinner in definitely. I do have feel and unsteadiness in driving so I have stopped driving and let my wife drive.