chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report was received from a physician via company representatives, and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 06-OCT-2014, the patient was vaccinated with an unspecified improperly stored dose of PNEUMOVAX 23 "10 Single dose 0.5mLVIs 10SDV" with lot number J009689 and expiration date of 29-JAN-2015 (route of administration and anatomical location were not reported), which was stored at 59.9 Fahrenheit (F) Degrees (15.5 Celsius) (highest recorded temperature)for a total of 5496 hours. The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator(R)". No adverse effect were reported nor product quality complaint was involved. This is one of several cases received from the same reporter. Additional information has been requested.
I had the normal chills and tiredness after the second dose.  But ln late March, I began tr have muscle and joint pain that got so bad I had to go to ER.  I couldn't walk or get in and out of bed.  I was diagnosed with Polymyslgia Rheumatica, an immune disorder which I exp[erienced in 2013.
Pt recv vax on 8/18/98; on unspecified date pt exp arthritis-like sxs including swelling &joint pain.  M.D. aspirated fluid; pt imp.
2nd dose in April 3rd dose on 19AUG2021; 2"  deep cut on the forehead after 3rd shot/Must have smashed my head on something; Tremendous pain in both arms after 3rd shot; Sick after 3rd shot; Tired after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Tremendous pain in both arms after 3rd shot), HEAD INJURY (2"  deep cut on the forehead after 3rd shot/Must have smashed my head on something), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose in April 3rd dose on 19AUG2021), ILLNESS (Sick after 3rd shot) and FATIGUE (Tired after 3rd shot) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017E21A) for COVID-19 vaccination.     The patient's past medical history included Pneumonia and Cancer.   On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced PAIN IN EXTREMITY (Tremendous pain in both arms after 3rd shot), ILLNESS (Sick after 3rd shot) and FATIGUE (Tired after 3rd shot). On 20-Aug-2021, the patient experienced HEAD INJURY (2"  deep cut on the forehead after 3rd shot/Must have smashed my head on something). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose in April 3rd dose on 19AUG2021). At the time of the report, PAIN IN EXTREMITY (Tremendous pain in both arms after 3rd shot), HEAD INJURY (2"  deep cut on the forehead after 3rd shot/Must have smashed my head on something), ILLNESS (Sick after 3rd shot) and FATIGUE (Tired after 3rd shot) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose in April 3rd dose on 19AUG2021) had resolved.      No concomitant medications reported.  No treatment information was reported by reporter   This case was linked to MOD-2021-297590, MOD-2021-297516 (Patient Link).
vax administered in the am, mom stated that pt cried nonstop from 2PM to 7PM; had a temp of 102; lt thigh red & swollen; APAP given every 4 hrs;
24apr90 pt vax 2nd heptaB. 01may90 pt devel urticaria particularly on arms.  sx persisted.
About 20 mins p/receiving DTP ears became very red & swollen then face mouth, legs & feet; red & swollen was given Phenergan & DPH; mom immed took pt seen by MD next day t102.8; PE neg x/sl red throat;
Doses were administered from a vial with slight solid particles; 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 PRODUCT CONTAMINATION PHYSICAL (Doses were administered from a vial with slight solid particles) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021 at 9:07 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced PRODUCT CONTAMINATION PHYSICAL (Doses were administered from a vial with slight solid particles). On 21-Feb-2021, PRODUCT CONTAMINATION PHYSICAL (Doses were administered from a vial with slight solid particles) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   On 12 Feb 2021, six doses were administered from a vial with slight solid particulates was noted clinging to the side of the vial. Dosage administration was suspended from this vial and after the vial was rested for 20 minutes at room temperature, the particulate disappeared.  No concomitant medication were provided.  No treatment information were provided.   Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow up received on 13-Jul-2021 appended to AER, new reporter added, batch number and clinical course of the narrative was updated.
Patient was given Flucelvax at 2:25 PM and immediately experienced anaphylaxis shock and became red in skin color and stated it was getting difficult to breathe. I immediately gave 1 dose of 0.3mg EpiPen to patients thigh and patient became stable within minutes. I offered EMS and patient and husband declined. Patient was monitored for another 20 minutes before they were stable and comfortable to leave pharmacy.
pt recvd vax & 16MAY94 devel a stiff arm & elevated t101.9;
Information has been received from a physician concerning a female who was vaccinated IM with the second dose GARDASIL. Three days after the vaccination, the patient experienced a rash on her upper back. Subsequently, the patient recovered from rash on her upper back. Medical attention was sought. Additional information is available.
Patient reported a rash across arm approximately the length of her hand - no red rash underneath the injeciton.  Patient received the shot on 05/19/2019 and the rash developed in the evening 05/21/2019.  Patient stated the area was sore or better described "tender" at the end of the rash furthest from the injection site.   Reported adverse event to GSK and the clinical staff stated that there had been several reports of extensive rashes )greater than 100 mm) and that these were not classified as "allergic reactions" and were not life-threatening.   Advised patient to watch the rash closely and call MD if rash continued to spread or pain worsened.  Advised patient to use OTC analgesics ad/or cold compresses to ease the pain.  Taking Benadryl 50 mg after work was not a necessiity but may be advised before bedtime for one dose only.
allergic reaction; face swollen; This is a spontaneous report from a non-contactable consumer (patient). A female unspecified age of patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. On an unspecified date, the patient experienced allergic reaction and had face swollen after the 2nd dose. At the time of this report, the outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient had a sore arm and difficulty sleeping due to soreness of arm. Arm did not feel better until today (2 days later). Patient believes he may have bursitis.
Information has been received from a physician concerning a patient who was vaccinated PO with a few drops of a dose of ROTATEQ (lot# not provided) and vomited approximately 2-3 ounces of milk.  The physician gave the baby a few more drops and the baby vomited again.  The patient sought unspecified medical attention.  The outcome was unknown.  There was no product quality complaint.  No further information is available.
Large, red, raised lump that was sore and itchy. That lasted for a week.   It then seemed to go away completely but returned yesterday. It?s not sore, but VERY itchy, red and raised again.
POTENTIAL ADVERSE EFFECTS; This spontaneous report received from a patient concerned a male 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, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. Batch number was not reported has been requested No concomitant medications were reported. On an unspecified date, the subject experienced potential adverse effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of potential adverse effects was not reported. This report was non-serious. This case, from the same reporter is linked to 20210426893.
Patient contacted our Immun Clinic.  He states redness, swelling and pain greater than expected; involving his deltoid region extending halfway to elbow.  Denies SOB, dyspnea, dizziness, facial/tongue swelling.
3 days after administration of above vaccines, patient developed high fever and severe neck rigidity, decreased mentation. Fevers and neck rigidity persisted for 6 days. Presentation concerning for aseptic meningitis
48 hours after injection, I noticed a red raised area about 2" in diameter approximately 1" from the injection site. It was hot to touch, with a noticable lump under the skin, mildly itchy/painful. It has increased in diameter each day, to 3" wide by 5" long on the 7th day from vaccination. Following application of ice packs at the recommendation of my PCP on days 5-7, the lump is much less noticable, and it is only slightly warmer than the surrounding skin to touch.
This literature marketed report as received from a physician, referred to 11 patients (age of 1-25 years old) who were diagnosed with blood malignancies (leukemias and lymphomas). Multiple studies indicated loss of immunity after chemotherapy and bone marrow transplant among pediatric cancer patients. Due to high probability of transfusions and reactivation of hepatitis B, some protocols recommend prc-screening of patients for hepatitis Bs antigen and antibody prior to the first dose of chemotherapy. We have noted that many cancer patients had negative prechemotherapy hepatitis Bs antibody even after standard immunization, while healthy controls mount a 90% response with detectable antibodies. This pilot study was developed to test the hypothesis that children with oncologic diagnoses have an a priori defective immune response to standard immunization. All patients with a new malignant diagnosis from the institution over the last 2 years were included in this retrospective study. Physicians have found 44 cases from which they excluded 2 with infantile acute lymphoblastic leukemia diagnosed before one year old. All had received their full immunizations (lot #, dose/frequency and route were unspecified) prior to diagnosis. From the included cases (age of 1-25 years old), 15/42 were found to have mounted an immune response to hepatitis B immunization, 16/42 were not reactive and 11/42 were not tested, resulting in an approximately 50% lack of immunity towards hepatitis B from the evaluated patients. When the diagnoses were analyzed, it was noted that there were 24 blood malignancies (leukemias and lymphomas) and 18 solid tumors (including brain tumors). For the blood malignancies: 11/24 had positive Hepatitis Bs antibodies, 11/24 had negative and 2/24 were not tested. For the solid tumors: 4/18 were reactive, 5/18 non-reactive and 9/18 were not tested. Even though half of solid tumors patients were not evaluated for immunity status, still the numbers show that a similar lack of immunity. This pilot study revealed that 50% of children with new cancer diagnosis have no immune response to standard hepatitis B immunization, compared with 10% of normal controls. Above data brings a different perspective on the current belief that chemotherapy results in loss of immunity suggesting a pre-existent deficiency in the immune response. A larger study would be developed shortly to confirm the pilot data and infer the significant implications of current findings. This was one of several reports that derived from the same literature link. A copy of the published article was attached as further documentation of the patient's experience. Additional information has been requested.
Mom called the health department on 08/16/2018 c/o rash/bumps/blisters all over the legs-whiny and feels warm-not around somewhere to check his temperature-going to monitor at this time. Mom called back on 08/17/2018, mom took patient to the doctor and was diagnosed as having the Chickenpox disease-temp. at the doctor was 99.4.
Pt complained of intermittent chest pain that began 2 weeks after vaccination and lasted 2-3 weeks. Chest pain is described as midsternal, lasted about 5 minutes and occurred a couple of times per day, but not daily. No SOB, no radiation. Pain stopped about 2-3 weeks after it started. Did not see MD, did not have any diagnostic studies. Is fully recovered.
I can't speak or eat; I can't speak or eat; his whole entire face went numb; he had a viral infection in the nerve ; 7th nerve; Ear ache; he had a viral infection in the nerve ; 7th nerve; This is spontaneous report from a Pfizer sponsored program. A contactable 51-year-old male consumer reported for himself. A 51-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8729), via an unspecified route of administration on 20Apr2021 (at the age of 51-year-old) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included type 2 diabetes mellitus. Concomitant medication(s) included dapagliflozin propanediol monohydrate (FORXIGA) 10 mg taken for type 2 diabetes. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8727), via an unspecified route of administration on 30Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient reported that he had ear ache on 23Apr2021. He went to his ear and throat specialist. He got an MRI done and his whole entire face went numb. It turned out he had a viral infection in the nerve (7 th nerve) and he just wanted to report this. He also stated that his whole face is grooving numb, and he cannot speak or eat. When asked about the treatment, consumer stated, he was currently not taking because any medication cause glucose level increase. Caller also stated that he received the second Pfizer vaccine on 20Apr2021, and he would like some financial assistance with medical issues due to facial numbness as a reaction. Reporter seriousness for I can't speak or eat was unspecified. The patient underwent lab tests and procedures which included magnetic resonance imaging: viral problem (viral something like that in my seventh nerve) on 06May2021. The outcome of ear ache and had a viral infection in the nerve: 7th nerve was not recovered, for I cannot speak or eat outcome was unknown and for Hypoaesthesia outcome was unknown.   No follow-up attempts are possible. No further information is expected.
pt experienced redness, hot, swelling at injection site the day following injection. pt sought treatment the following day and was prescribed an antibiotic and an antihistamine
No adverse effect noted; Patient given PREVNAR instead of PNEUMOVAX accidentally given by fill-in nurse helping that morning
An allergic reaction after I left the Pharmacy. Swelling of the throat, difficult breathing, fast heartbeat, dizziness, headaches, fever and hives and welts severely bad. I' am currently taking XYZAL AND A PEPCID PILL TO CONTROL IT EVERYDAY AND I Have A Epi Pen to carry with me everyday for the rest of my life.
Blood pressure spiked to above 200 systolic 6 weeks after receiving the booster. Went to er twice in one week.  Finally pressure returned to normal after about 2 weeks. Am back to maintenance dose of my blood pressure medication. As I was before the booster shot
A little over a month after I received the J&J Covid shot I have come down with what doctors think is early Sjogren's syndrome. I have extremely dry eyes, eye pain, moderate dry month, and an increase in migraines to a chronic level since the shot. Standard blood work has not determined a diagnosis, however, "early Sjogren's" bloodwork has shown a probable diagnosis along with symptoms that do not ever go away. The pain and dryness to my eyes and the chronic nature of migraines and headaches have changed my life for the worse and made it difficult for me to do things. I also can no longer wear contacts.
I believe I had a Takotsubo (TTS) cardiac episode and or cardiac??? , increase in myocarditis??? from the vaccination. I felt it happen during Friday night. I had/have other symptoms too (chills, fever, pain, weakness, headache, nausea, headache, swollen glands under arm, ANS dysregulation). The symptoms are what happens after a TTS episode (chest pain, shortness of breath, vasovagal symptoms, heart dysregulation, extreme fatigue, nausea) and autonomic nervous system dysfunction. Also developed neck pain, swollen lymph nodes, vision problems, arm pain, abdominal pain.
Breakthrough case of COVID on 11th and began Paxlovid on that evening. Symptoms were mild but began resolving on the 12th.
Per mom, child was in the ER last night.  After leaving our office @ 2:06 pm.  Patient was fussy, throwing up, and swollen on the admin. site.
On 1/30/09 Pt presented with a temperature of 104.2(f) with no other signs.  Drew blood cultures positive for Invasive Streptococcus Pneumoniae. Treated with Cefpriaxone at office visit and return in 24 hours for another injection became rapidly better.
I received the 2nd vaccine around 7:24am 2/17/21. My right arm hurt a lot only an hour after receiving the vaccine. Last time it took at least 18 hrs to notice a sore arm. Then there was onset of mild fatigue around 2pm & onset of chills and mild aches around 2:30pm. From about 5pm-3am I had a fever ranging from 100.2-102.5. I took Acetaminophen 500MG tablets (x2) to help manage symptoms. Once at 7:00pm and another at 3am. The next day 2/18/21 I still had fatigue and alternating between painfully chills to feeling really hot, but no fever. I took 2 more rounds of  Acetaminophen that day. On the third day I felt normal with a mild soreness in my arm.
Bad headache; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 first dose on 18Jan2021 15:30 on left arm at single dose for COVID-19 immunization at Parking lot of a big stadium. Medical history included stressed and headache, both from 18Jan2021 before vaccine and medication to help sleep. Concomitant medication included ongoing clonazepam (KLONOPIN) tablet at 2mg pill at night to help sleep. Vaccine not Administered at Military Facility. No History of all previous immunizations with the Pfizer Vaccine considered as suspect. No Additional Vaccines Administered on Same Date. No Prior Vaccinations within 4 weeks. She is calling because she got the vaccine today and she has a bad headache. She mentioned she knows headache is a possible side effect. However, she is calling to see what she can take or what she cannot take for the headache. She stated before getting the vaccine she was stressed and had a headache that had started today, 18Jan2021, before she got the vaccine. She mentioned she was waiting 3.5 to 4 hours before getting the shot and that is when the headache started. However, after getting the vaccine it has gotten worse and it is to the point where she wants to place an icepack on her face. Stated it could be situational. She knows she was in the car for at least 5 hours. She also mentioned the paperwork we provide with a list of symptoms should also have listed what medications she can or cannot take. She finds it troubling that we do not have the listed on the paperwork. We have headache could be a possible symptom, but no information on what can be taken for symptoms. She also mentioned she needed her reading glasses to attempt to read the patient card provided that list the lot number and details regarding date for next dose. She then stated after looking at the card it is impossible to read. She cannot read the person's handwriting. The lot number is so messy. She believes it is: L2 7 or 8, 922 or 422, something like that, she cannot really tell the handwriting is so messy. The event not require a visit to Emergency Room or Physician's Office. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a health care professional concerned 2 patients of unspecified sex, age, race and ethnicity. No past medical histories or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 202A21A, expiry: unknown) dose was not reported, 1 total administered on 20-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  It was reported that the 2 patients had a polymerase chain reaction (PCR) based corona virus disease (COVID) test which came back positive. Both had fever, headaches, nasal congestion, and diarrhea. The patients experienced confirmed COVID-19 infection, and confirmed clinical vaccination failure. The patients were still recovering. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from confirmed COVID-19 infection, and the outcome of confirmed clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210846435.; Sender's Comments: V0. 20210846649-covid-19 vaccine ad26.cov2.s -confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS