chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Tested positive; Sick as a dog; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive) and COVID-19 (Sick as a dog) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068#23A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 ml. On 12-Jan-2022, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive) and COVID-19 (Sick as a dog). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive) and COVID-19 (Sick as a dog) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2022, SARS-CoV-2 test: negative (Negative) Negative. On 12-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.   No Concomitant product use was reported.  The patient received the Moderna booster and 3 days later tested positive for Covid. It was reported that the patient prior to getting the booster had a negative result, on the 07-Jan-2022.   The patient was sick as a dog 3 days after the shot and tested positive.  The patient received the booster on Sunday 09-Jan-2022, they wrote 11-Jan-2022 but patient got it on 09-Jan-2022.  No treatment information was provided.  Company Comment: This spontaneous case concerns a 67 year old female with no reported medical history , who experienced, non-serious  , unexpected , AESI events  of Covid 19 and  SARS COV-2 test positive which occurred 3 days post vaccination with the 3rd dose of mRNA-1273 vaccine .The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given and also the outcome of the events was reported as unknown. The age of this patient is considered as a confounder for this case ( elderly population are vulnerable to Covid 19  infection due to altered immune response). The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jan-2022: Follow up received includes no new significant information.; Sender's Comments: This spontaneous case concerns a 67 year old female with no reported medical history , who experienced, non-serious  , unexpected , AESI events  of Covid 19 and  SARS COV-2 test positive which occurred 3 days post vaccination with the 3rd dose of mRNA-1273 vaccine .The re-challenge for this case is not applicable since the events occurred after the 3rd dose and no additional doses will be given and also the outcome of the events was reported as unknown. The age of this patient is considered as a confounder for this case ( elderly population are vulnerable to Covid 19  infection due to altered immune response). The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
Graves Disease  10/14/08 Reviewed PCP medical records of 6/2007-9/2008. FINAL DX: Graves disease Records reveal patient experienced usual state of good health on 6/8/2007 visit & received HPV#1 & varicella.  Received HPV#2 8/10/2007. HPV#3 11/12/2007.  Referred to ortho 10/07 for chest deformity & scoliosis.  Dx w/ADHD 11/07.  Had fatigue/malaise & acute URI 11/07.  RTC 2/25 w/swollen neck, throat pressure, increased HR & BP & dx w/goiter.  Labs & US ordered & referred to endocrine.  Exam revealed prominent eyes w/periorbital edema, tremors of tongue & extremities, jittery, speech fast, difficulty sleeping. Tx w/meds.  Developed allergic reaction & seen in ER where dx w/dermatographic urticaria.  Referred to allergist.  Referred for second endocrine opinion which concurred.  Developed myalgias & frequent hives.  Developed weight gain & hair loss, meds adjusted.
Immunization administered after expiration of 9/30/22, however per the manufacturer the stability is good through 10/19/22. No adverse event, no treatment, patient is fine
At about 8:45 last night (on 10/29/21), she was a little fussy and fell asleep. She felt a little warm, but her fever was 99. Mom went ahead and gave her 1.25 mL of Ibuprofen. About 20 minutes later, dad was holding the baby and she looked like she was jerking, and her eyes rolled back. She had full body jerking. Dad called mom over and mom felt like it was a seizure, it lasted maybe 30-60 seconds. Afterwards she seemed to just lay there and was very tired and fell asleep. They took her to the hospital and her temp was 100 degrees. They did bloodwork and a chest X-ray. They tried to catch a UA but were unable. They watched her until about 2 am and the ER was watching her.  They diagnosed her with a febrile seizure and sent her home.
This spontaneous report was received from a nurse, refers to a patient of unknown age and gender. Medical history was not reported. On 30-JUN-2014 the patient was vaccinated with an expired dose of M-M-R II, injection, 0.5ml subcutaneous, lot # H012142, expiration date 29-JUN-2014. Concomitant therapy was not reported. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
On January 9, 2022, my wife tested positive for Covid.  I was already suffering some of the same symptoms.  I was tested on Monday, January 10, 2022, and my test results came back positive the following day.  On Wednesday, under the advice from my cancer doctor's nurse, I went to the Emergency Room of Hospital for an infusion.  I sat in the ER for several hours, and then was rejected for the infusion despite my CLL.  I was sent home with no advice on what I could do to deal with the symptoms except to go buy an oximeter, and wear a seatbelt when driving.  I used cough drops and  tylenol and toughed it out.  On Sunday, January 16, I nearly choked to death from my Covid cough and drainage blocking my airways.  Luckily, after 10 minutes or so I could breathe well enough.  The fever was gone by then, but I held onto the cough in a lessening form for about a month.   Other than some fatigue, I feel like I'm pretty much recovered now.
1 day after 2nd Pfizer Covid vaccination, patient developed a shingles rash on his right arm.  Patient was started on valtrex and eventually gabapentin and lidocaine patches for treatment by his pediatrician.  Rash lasted approximately 3 weeks and patient?s symptoms completely resolved.  If not, patient never had chickenpox, but did have his routine chickenpox varicella vaccinations at age 1 and 5 as recommended by his pediatrician; therefore this shingles outbreak was not a wild type shingles outbreak, but rather a  outbreak from the weakened varicella vaccine strain given to him by varicella vaccination 13 and 9 years prior.
Patient was receiving first Moderna dose, however he was only given 0.25mg (booster dose).
Red, swollen, pain, itching at injection site-still, more than 72 hours after shot
Back feels as if baseball is being shoved into mid-back (feels like joint pain)  8/10 Wrist and fingers feel sharp pain in joints (wrist and finger joints in both hands) 7/10  Soreness at injection site 3/10  Headache 3/10  Sweating (started at  7-8 am)
Fever, chill, pain in my arm legs and flank, headache, nasal  congestion, no energy, headache
This spontaneous report as received from a healthcare worker refers to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of improperly stored GARDASIL, (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Rash around site p/4th dose of vax; large area some macular-apaular not typical of drug reaction 25FEB93; pt recovered; recvd 5th dose w/o further reaction;
Received 4 doses of Covid Vaccine, 2 different manufacturer.; This spontaneous case was reported by a physician and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 4 doses of Covid Vaccine, 2 different manufacturer.) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Astra Zeneca (Patient received two doses of vaccine in fall 2020 as part of the Astra Zeneca trial) in 2020. Past adverse reactions to the above products included No adverse event with Astra Zeneca.   In March 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 4 doses of Covid Vaccine, 2 different manufacturer.). In March 2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 4 doses of Covid Vaccine, 2 different manufacturer.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment medications were reported  Patient  was not sure which arm of the AZ trial he was in at that time, so opted to receive Moderna Patient found out later that he had received active AZ vaccine.
Information has been received from a healthcare worker concerning a 52-year-old female with a history of organ transplant and no known drug reactions or allergies who on 31-OCT-2005 at 13:30 pm. was vaccinated intramuscular with a 0.5 ml first dose of pneumococcal 23v polysaccharide vaccine (lot 650327/0792P).  It was reported that the patient had the flu on 26-OCT-2005, however, there was no illness at the time of vaccination.  On 01-NOV-2005, the patient developed swelling, stiffness, and a rash on the upper arm.  The patient was treated with steroids.  The patient's outcome was reported as recovered.  A product quality complaint was not involved.  Follow up information was received from the healthcare worker who reported that on 31-OCT-2005 at 17:00 pm., the patient had difficulty breathing, a body rash, the upper shoulder was inflamed, red, and swollen, and she was lightheaded.  The patient had a medical visit with her family doctor and an exam.  She was treated with 20 mg of oral PREDNISONE and a topical steroid cream.  The patient recovered on 01-NOV-2005.  It was noted that the patient had no adverse events following prior vaccination.  No further information is expected.
New onset seizure (remote history of neonatal seizures attributed to hypoglycemia so not actually a risk factor for further lifetime seizures)
Pt felt fluish, shaky, feverish("high") for less than 24hrs after high dose flu shot.
1hr p/vax pt started screaming;pt given 2 doses of APAP;pt screamed throughout cont to whimper/cry w/anybody movement;no local rxn @ site;total screaming time 11hr;body twitching, pale;unable to move 1 side of body;t100;appetite inc;
Skin blotches around left side of face, lower lip swelled referred to aa a cherry, itchy ear, scratchy throat similar to a strobe light effect within 10 minutes of injections. Spoke with medical personals and  she took a Benadryl  pill. We waited 40 minutes then left. The swelling blotches started to stop, however at this time she cannot lift her arm at all, her chronic leg pain shot up to her groin area and  a migraine has occurred. Gave her Acetaminophen has not help. Notified her primary care physician who advised that she refrain from taking second dose.
Sudden onset chills, lightheadedness, malaise, anxiety, and intense sweating roughly 2-3 minutes after injection, peaking around 6 minutes after injection and subsiding quickly afterwards.  Symptoms are in line with reported cases of hypertension immediately following injection. No treatment needed as symptoms subsided quickly, no tests performed.
Client states that he had vestible like lesions at base of nostril (cold sore like) that oozed and then crusted over. He stated that he had never gotten cold sores ever before.
In the afternoon I noticed that I was getting a sore throat. It was moderate. I completed a COVID 19 home test on October 3rd and it was positive. On October 3rd, I did a tele visit with the doctor and I was not feeling really bad, so she did not prescribe. I was in bed for 2 days with nausea really bad. I could not eat or drink anything. By the 6th I felt a lot better. I never got a temperature above 99 degrees. I was tired afterwards for a couple of weeks but have since completely recovered.
"Blueness" around face w/general weakness; Rec'd inject about 10AM & approx 4PM experienced the rxn which lasted 30 to 60 min;
Information has been received from a consumer concerning her 6 year old niece with no pertinent medical history and an allergy to milk products, who was vaccinated with a dose of varicella virus vaccine live (Oka/Merck). On 03-MAR-2008, the patient was diagnosed with shingles on her right arm. "She was given an antiviral and Motrin for the pain."On 04-MAR-2008, the patient's mother reported that "her daughter had developed a few new blisters on her right hand. She had also been experiencing severe stomach pain, vomiting, and loss of appetite and weight. It was noted that the patient's father noticed two blisters on his arm but was not sure if it was related to his daughter's case of shingles. No further information was given. Unspecified medical attention was sought by the pediatrician. The outcome was reported as not recovered. There was no product quality complaint. Additional information has been requested.
This case was reported by a pharmacist via call center representative and described the occurrence of influenza-like symptoms in an adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. The reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The age group was not reported but was selected as adult as per vaccine indication. This case is one of 8 cases reported by the same reporter.
DILATION OF BILE DUCT; ACHING ALL OVER; FATTY LIVER; This spontaneous report received from a parent concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included cerebral palsy. The patient did not have any prior problems. The patient had no gall bladder. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 204A21A) dose was not reported, 1 total, administered on 25-MAY-2021 in left arm for prophylactic vaccination. No concomitant medications were reported.  The patient was very very ill, described as on 26-MAY-2021, the patient experienced severe pain all over radiating into breast bone. On 31-MAY-2021, the patient was taken to emergency room (ER) as pain was so severe that patient could hardly breath. By then it was more than aching all over. The blood work looked good as of 31-MAY-2021. She had normal ALT/AST (Alanine aminotransferase/ Aspartate aminotransferase) as of 31-MAY-2021. By 06-JUN-2021, the patient was taken at ER because she had pain all over, was given ibuprofen and Tylenol and she did not get any better. The pain was so severe that it was up into her breast bone. The hospital did Computerized tomogram Scan and thought it was colitis. Then she had a Esophagogastroduodenoscopy and colonoscopy to see what was going on. The colonoscopy found nothing, though esophagus and stomach was bright red, might be they thought it was gastritis. She was given medicine for it. The ultrasound found that she had dilation of bile duct on 17-JUN-2021, and since she had no gall bladder that was odd. In JUN-2021, the gastrologist doctor diagnosed her to have a fatty liver which they did not know about. By the 15-JUN-2021, her liver enzymes were way up (abnormal liver enzymes). On 29-JUN-2021, ALT was 59 and AST was 41 which was double what it should be. Her liver had been totally affected.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from dilation of bile duct, and aching all over, and the outcome of fatty liver was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210725320-covid-19 vaccine ad26.cov2.s-dilation of bile duct. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Lack of energy, lethargic for the last 8 months.   Irregular periods.  Never a history of irregular periods prior to the vaccine.   Periods are unpredictable, very heavy (one pad or tampon won?t last an hour) period is now long or short and then comes back.   I am very concerned about this change in my body.
Erythromatous vesicular rash in clusters on L shoulder, chest, back and posterior neck.  No pustules. No pruritis or pain.  Smallpox site on L arm is healing well with a scab in place.  Started 12 days after vaccine was administered.  He reports good wound care of site.
Breakthrough case COVID-19 after fully vaccinated with 3 doses Moderna. This is repeat test, initial positive on 7/27/2022.
Within 24 hrs of receiving flu vaccine, patient developed tingling in his toes - > to his legs and hands without further progression until 21 OCT, when the tingling moved above his waist. Patient sought evaluation and was admitted to his local hospital. (Documentation from ER eval, hospital admission, and follow up outpatient Neurology evaluations enclosed). Patient continues to experience sensory symptoms today with most recent Neurology evaluation at the clinic in DEC 2013. (EMG report enclosed - reveals an axon loss neuropathy). OF NOTE: Patient developed sensory and motor symptoms following vaccines administered in 2009, fall 2011, and OCT 2012. (2 previous initial VAERS reports filed, as well as 1 follow up VAERS report filed).
Aprox. 5 minutes post vaccination patient complained of dizziness. When interviewed he stated he had not had any water only coffee today.  Patient was provided a bottle of water to sip on while he finshed waiting in the vechile for observation for 15 min. About 5 mins later, checked on patient and patient reported to be doing fine, no complaints and dizziness had resolved. 5 minutes later patients wife called over observation staff reporting patient was having chest pain. Patient appeard altered, but with history of dementia. 911 was called and patient was transported via ambulance. Complaining of 5/10 dull pain in his left upper chest improved when given nitroglycerin en route ED department. No SOB and patient denies ever having pain like this in the past. Observed in the ED for approx 6 hours. Patient then discharged home.  Per ED provider "85 y/o male who presents w/ CP s/p COVID vaccine inj. Low clinical suspicion for acute cardo pul pathology give atypical hx, neg ED workup. No recurrence of sx while being observed in ED. Dc w/ con sx care, f/u PCP
1 min post inj cc/lightheaded, dizzy, blurry vision, ringing in ears.  Pt  reported vasovagal effects with  needles.  Subsided after 5 mins.
Experienced chest pains after receiving a Covid vaccine; This is a spontaneous report received from contactable reporter(s) (Physician) from a sales representative.  An adolescent female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CHEST PAIN (non-serious), outcome "unknown", described as "Experienced chest pains after receiving a Covid vaccine". The event "experienced chest pains after receiving a covid vaccine" was evaluated at the physician office visit. Additional Information: It was reported as patient was 16-17 years, experienced chest pains after receiving a COVID vaccine at a local retail pharmacy. Patient was following up with her Paediatrician (withheld) to be cleared to continue basketball. (withheld) does not know which manufacturer of the COVID vaccine she received or if it was her first or second dose. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Administered expired Moderna COVID-19 vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included BUSPIRONE, FLUOXETINE, ALBUTEROL [SALBUTAMOL], FENOFIBRATE, OMEPRAZOLE, CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) and MIRTAZAPINE for an unknown indication.    On 18-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine). On 18-Nov-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired Moderna COVID-19 vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.   Treatment information was not provided.
COVID Arm - hard lump with redness and itching that didn?t appear right away.
This initial non-serious spontaneous case, was received on 01-Nov-2017, from a physician, concerning an adult male patient of unspecified age. This refers 67 of 84 patients. On an unspecified date in Oct-2017 (between 25-Oct-17 to 27-Oct-17), the patient was administered with AFLURIA (TIV) Thiomersal (batch number: 14649211A, dose, route of administration, anatomical location and expiry date: not reported). It was reported that, the vaccine was stored in cooler with ice packs for 6 days and had reached unknown temperature during transport instead of storing at 36-degree F and 46-degree F (2-degree C and 8-degree C). And the same was administered to the patient. The reporter stated that the temperature was not monitored on 24-Oct-2017 (could have been between 2-8C, but not certain) and there were no reports of adverse effect after vaccination. The vaccine had been discarded. Follow up received on 09-Nov-2017 from a physician: Added event and reporter's comment. Amended narrative accordingly.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Mild, Systemic: Visual Changes/Disturbances-Mild, Additional Details: Patient was vaccinated at about 4:45pm, felt dizziness & lightheadedness shortly after. Following that patient states that her field of vision became black and foggy, she then was witness dropping to a knee. Pharmacist helped her to a chair and father got her some water. Patients skin appeared pale and felt clammy at this point. Her blood pressure was check at 3:57pm (81/50) and then again at 4:05pm (113/67). She felt and looked better, so the pharmacist walked both her and father to vehicle.
pt cried unconsolably 11SEP96 during evening for 1 1/2hr;very quiet & sleepy since that time;hard 3cm area @ inj site w/o redness;
Case previously recorded as MA2009-4057. Initial case report received from a nurse, via Novartis Medical Communication, on 11 NOV 2009. A 6 month-old female patient was vaccinated with 0.25 ml of S-OIV FLUVIRIN (batch no. 102042P1) i.m. on 11 NOV 2009, an off-label indication. No adverse event was reported. MedCom reference no.: NA09-008013.