chrisvoncsefalvay/vaers-outcomes huggingface dataset:
RASH; 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: ZM021B0101) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow up to request batch/lot numbers. Concomitant medications included macitentan for drug used for unknown indication. On an unspecified date, the subject experienced rash. Treatment medications (dates unspecified) included: prednisone. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of rash was not reported. This report was non-serious.
2/8/2023 I started with a little stuffiness and runny nose. That night I woke up with a crushing headache. I took a home COVID test and it was negative. The next day I had congestion and a little bit of a cold. Basically, I had head cold symptoms. I also had a little bit of a cough and were tired. I took another at home COVID test and it was positive. I called my doctor and was prescribed PAXLOVID. I started the PAXLOVID that same day, 2/9/23. On 2/14/23 I felt pretty good. 2/15/23, I felt absolutely normal and had a negative COVID test. On 2/16/23 I began having a runny nose again. On 2/17/23 I had a lot of congestion, huge amount of nasal drainage, tired and tested positive for COVID with at home test. My worst day was on 2/19/23, and after that it got better. I have recovered. I had a negative at home COVID test on 2/22/23, 2/23/23 and 2/24/23. I have recovered.
pt devel maculopapular rash on trunk 7 face 11 days p/MMR;may have had a low fever also;
This spontaneous report was received from a physician, via company representatives, and refers to a patient of unknown age and gender. Information about the patient's pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On 02-JAN-2015, the patient was vaccinated with an improperly stored dose of PNEUMOVAX 23, "10PK-0.5ml SD-PFS LLokwTip" which had the lot # K009874 with expiration date 19-MAR-2016, (dosage number and route of administration were not reported). Nonetheless, no adverse effects were reported and no product quality complaint was involved. On unspecified dates, the vaccine experienced two temperature excursions one of 48 hours and other of 40 hours. The lowest recorded temperature 34 F (1.111111111 Celsius) and the highest recorded temperature was 47 F (8.333333333 Celsius). The vaccine status was reported as "in excursion". The vaccine storage criteria and the vaccine excursion were reported as "Refrigerator (R)". This is one of the several reports received from the same reporter. Additional information has been requested.
Patient was vaccinated with first dose of SHINGRIX at Pharmacy on May  9, 2018. On May 30, 2018 he was admitted to Medical Center with acute pancreatitis. He was discharged from Medical Center on 6-7-18. Pancreatitis was resolved at discharge.
pt recvd vax & 2 hrs later turned purple & had trouble breathing; mom related to MD that pt became rigid & had jerking movements;
Headache, Myalgia, Arthralgia, chills, fatigue, soft stools, loss of appetite Narrative:  Employee states: after second vaccination she started to feel tired around 9pm the same day. On Wednesday, 1/20/2021, she awoke with chills, frontal headache, soft stools, significant tiredness and moderate-sever bone and muscle pain that lasted all day. She was unable to woerk. Spent day in bed, no appetite. Pain was not controlled with tylenol 1000mg every 3 hours x 3 (started at 5am), so switched to Motrin 200mg every 6 hours around 2pm. Thursday 1/21/21 still had bone pain (level 4) and soft stools but was able to work. By 1/22/21 states she feels better
This patient received a total of 3 doses of Pfizer vaccine. The first dose was administered in February 2021 outpatient at a Pharmacy. The patient has been admitted with us for sometime and we were not aware the patient had already received a vaccine. We vaccinated this patient at a 3 week interval per the Pfizer dosing guidelines and it was realized that he already had received a dose when manual entry into the state portal was occurring. Patient has not experienced any medical adverse effects from the additional dose at this time.
At the time of the first shot my hands got itchy within 5 minutes of shot being administered. I got really anxious and hyper. About 2 hours later I was so tired I could not move. Within 48 hours a rash started to appear behind my right ankle bone. It was not itchy it burned and looked like little red dots. I also began getting headaches. Everytime i ate any food my stomach was nauseous and i really just did not want to eat. The rash behind my right ankle bone started to get bigger and almost looked like ring worm. Between the first and second shot, the same rash started to appear in the same spot behind my LEFT ankle bone. The stomach issues and not hungry issues continued. By the time i got my 2nd shot i had the behind both ankle bones, and had begun to get more spots on my legs. After the 2nd shot the rash went crazy. Bigger areas were covered on my legs with the rash. AAnd they were matching spots on each leg. I ended up in the ER with kidney stones beginning of June. The rash started going away in June as well. 24 hours after the 2nd shot was administered i had horrific pain in both of my legs, from my hips down to my toes, i could not walk. I had a fever of 102.8 and could not stay awake. I was sick to my stomach and could not eat. This lasted almost 3 days. I had random dizzy spells. And brain fog. The rash went away in June and all of the other sumptoms such as the dizziness and brain fog and nausea have continued. It is now January 11, 2022 and beginning of November the rash re-appeared. Same exact way as it did the first time. Started behind my right ankle bone, and the my left. I currently have spots behind each ankle bone. On the back of my calf right below where my leg bends at the knee, on both legs. Inside of each thigh. Outside of each thigh in two different spots. The spots furth up my legs are big. easily 4-5 inches across and wide. I have never had anxiety or panic attacks. and they are getting worse and worse as time goes on. I have shortness of breath and cannot stop the anxiety and panic thoughts from being in my mind. I am not suicidal. But my anger and my patience are gone. I am sad and depressed constantly its almost like i am stuck in my own head. I have never actually had covid.
Pediatric medical records has been received from a physician's office concerning a male patient with poor weight gain and a history of premature birth who on 31-OCT-2008 was vaccinated orally with a first dose of ROTATEQ (lot # 660878/0502X) (expiration date November 2009).  Concomitant vaccinations on the same day included a first dose of PEDIARIX (lot # AC21B198BA) (expiration date January 2011) in the left thigh (LT) and a dose of PREVNAR (lot # C99098) (expiration date April 2011) in the right thigh (RT).  On 30-DEC-2008, the patient was vaccinated orally with a second dose of ROTATEQ (lot # 662652/1272X) (expiration date May 2010).  Concomitant vaccinations on the same day included a second dose of PEDIARIX (lot # AC21B198BA) (expiration date January 2011) in the left thigh (LT), a second dose of PREVNAR (lot # C87310) (expiration date April 2011) in the right thigh (RT) and a first dose of ACTHIB (lot # UF519AB) (expiration date August 2010) in the right thigh (RT).  On 19-JAN-2009, the patient experienced low lid swollen/puffy and eye with yellow/green drainage.  The patient was prescribed medication (therapy illegible), gtts QID X 7 days.  On 09-FEB-2009 the patient experienced fever (101) and cough.  It was reported that the fever decreased with TYLENOL.  On approximately 13-FEB-2009, the patient experienced fussy, spitting, constipation, and right drum red and bulging.  The patient was prescribed AMOXIL 1/2 teaspoon PO BID X 10 days, rest and fluids.  At the time of the report, the patient's status was unknown.  On 03-MAR-2009, the patient was vaccinated orally with a third dose of ROTATEQ (lot # 663263/1489X) (expiration date August 2010).  Concomitant vaccinations on the same day included a third dose of PEDIARIX (lot # AC21B198BA) (expiration date March 2011) in the left thigh (LT), a third dose of PREVNAR (lot # D07543) (expiration date May 2011) in the right thigh (RT) and a second dose of ACTHIB (lot # UF547AC) (expiration date November 2010).  Additional information has been requested.  WAES # 0904USA00095 is associated to WAES # 0806USA03426.
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Apr-2021 at 3:54 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 29-Apr-2021 at 3:54 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 38.62.  Concomitant products were not provided.  On 29-Apr-2021, Excursion time was 10 AM, temperature was 33, total doses given for the day was 201. Condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 19-Apr-2021, vial was moved to clinic on 29-Apr-2021.5 vials were sent to clinic. Vaccine BUD date was 19-May-2021.   On 29-Apr-2021, vials were stored in cooler 1, at following time and temperature excursion range was between range of 33 to 45 degree from 09 AM to 4 PM.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
After receiving the booster shot, I experienced prolong soreness in my left arm and slight soreness in my chest. After the soreness subsided I still feel frequent tension or pressure in my chest.
Noticed red swelling size of tennis ball on left upper arm on  1/9/21 at 8am due to itching, with  no pain or problems breathing.
HEADACHE ON DAY 1 AND 2 AND 3 THEN SORENESS ON DAY 3 AND THEN FAST HEART BEAT ON DAY 4 AND CHILLS ON DAY 7 AND REDNESS AND WARMTH TO TOUCH AND MUCH ITCHING ON DAY 5 UP TO NOW
Two days post vax, the pt was seen in the ER with a fever of 104 and lack of appetite. Pt developed no rash.
Initial information received on 08-Feb-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case is linked with case 2019SA040495, 2019SA040916 and 2019SA040918 (same reporter). This case involves 10 year old male patient was vaccinated with IPV (VERO) [IPOL] (lot: P1A242M, expiry date: 26-Apr-2020) via intramuscular route in the left deltoid, on 05-FEB-2019 which had a temp excursion on 04 Feb 2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS B VACCINE (HEPATITIS B VACCINE); ADACEL; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE) for Immunisation. It was an actual medication error due to incorrect product storage as after the vaccine had a temp excursion on 04 Feb 2019, patient received IPOL.. Vaccine stored at temperature outside the recommended range It was unknown if the patient had any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of document held by sender: none.
Developed raised red lump on (L) arm with pain. Lump initially coin sized. Redness began to spread. Seen 10/9/13 in office and started on KEFLEX for suspected skin infection. Went to urgent care on 10/10 and given prednisone for "allergic reaction" as redness still spreading. Swelling and redness improving by next day and improved by 10/14.
Patient received 2nd dose of vaccine too early. First dose was administered on 5/28/2021. No adverse reactions to vaccine noted. Patient will receive repeat dose of vaccine since 6 month interval has passed since invalid dose given.
Presented with SOB/fever; DX: Covid PNA Labs: D-Dimer: 0.62; CRP: 11.6; Ferritin: 368 CXR: bil infiltrates   TX: Steroids, remdesivir, lovenox, zinc, singulair; Initially on 5 LPM NC; went up to Bipap and High Flow O2 (60/80); back down to 3 LPM NC at d/c; cont O2 @ home
Local reaction to Zoster noticed by family 24 hours after vaccine. Patient came in to me 48 hrs after vaccine because I asked her to if got worse. Red, raised area below vaccine administration site, warm to touch about 3 inches in diameter.
Client's left upper arm is red (blotchy), swollen, and tender to the touch. Client stated that he was not feeling good. He ate and felt better after. Client does not have a fever.
On October 24, 2021, I was diagnosed with an unprovoked blood clot in my left leg. I have never had a blood clot before and I dont' have any or have done any of the things that cause blood clots.
Dry throat, ears feeling full, numbness in tip of tongue, some tingling in teeth, pain inside arm around elbow in injection arm and in neck on side of injection site - all onset about 3 hours after receiving vaccine. Took 25mg antihistamine (diphenhydramine). Symptoms did not go away immediately but did not get worse within the 30 minutes after taking the antihistamine.
UNCONTROLLABLE SHAKING; VERTIGO; DIZZINESS; HEART RATE ELEVATED; FEELING COLD AS HECK LIKE A FREEZING SENSATION; SHOT HURT LIKE HECK; LOT OF MUSCLE PAIN ESPECIALLY IN UPPER BACK ALONG THE SPINATUS MUSCLE; This spontaneous report received from a patient concerned a 60 year old adult male. The patient's weight was 127 pounds, and height was 68 inches. The patient's pre-existing medical conditions included: The patient was exposed to 5FU (Fluorouracil) and faced respiratory issue. The patient was previously on a steroid breather to help with his breathing. The patient received vaccination with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration was not reported, and batch number: 1802070 and expiry: Unknown ) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. On unspecified date following vaccination with covid-19 vaccine ad26.cov2.s (series 1), the patient experienced calf pains, calfs was enlarged and edema of ankles. Calf pains are resolved. calf swelling not recovered and outcome of ankle edema was unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient received covid-19 vaccine ad26.cov2.s (Dose number series 2) (suspension for injection, route of administration was not reported, batch number: 1822811 expiry: Unknown) dose was not reported, administered on 09-NOV-2021 for prophylactic vaccination.  On AUG-2021, The patient had a full workup done. On 09-NOV-2021, the patient had uncontrollable shaking, the patient stated the shot hurt like heck and that he can tolerate a lot of pain. On the same day he was experiencing a lot of muscle pain especially in his upper back along the spinatus muscle. He stated that his blood pressure was normal but that his heart rate seems elevated which he stated he usually has a heart rate of 45 beats per minutes (bpm) but that it was at 68-70 beats per minutes (bpm). Patient stated that he was experiencing vertigo and dizziness as well. He stated that he was feeling cold as heck, like a freezing sensation. but that his temperature was normal. He stated that he was allergic to Chloramphenicol, takes Flomax 0.4mg daily, Losartan 50mg daily, Amlodipine 10mg daily, Motrin as needed.  Laboratory data included: Blood pressure and Body temperature was normal. Cholesterol was 130 mg/dL, and Heart rate was 68-70 beats per minutes (bpm). On unspecified date unspecified laboratory tests showed with no blood clots, patient feels its possible that the smaller veins may have had clots but did not show up on measurable tests, and Pain scale 1 to 2 or more out of 4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from feeling cold as heck like a freezing sensation, vertigo, shot hurt like heck, lot of muscle pain especially in upper back along the spinatus muscle, dizziness, and heart rate elevated, and the outcome of uncontrollable shaking was not reported. This report was non-serious. This case, involving the same patient is linked to 20211165581.
Kicked my butt; This case was reported by a consumer via media and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On 12th September 2021, the patient received the 1st dose of Shingles vaccine. In September 2021, less than a week after receiving Shingles vaccine, the patient experienced feeling abnormal. On an unknown date, the outcome of the feeling abnormal was unknown.   It was unknown if the reporter considered the feeling abnormal to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient. The age at vaccination was not reported. The patient received the shot a day before reporting and stated it kicked the butt. The patient stated that it was better than getting Shingles.
Arm is red; Pain in her arm; Arm is like a rash; Nausea; Arm is very itchy; Light headed; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Arm is very itchy), DIZZINESS (Light headed), ERYTHEMA (Arm is red), MYALGIA (Pain in her arm) and RASH (Arm is like a rash) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced PRURITUS (Arm is very itchy), DIZZINESS (Light headed), MYALGIA (Pain in her arm), RASH (Arm is like a rash) and NAUSEA (Nausea). On 05-Apr-2021, the patient experienced ERYTHEMA (Arm is red). The patient was treated with FEXOFENADINE HYDROCHLORIDE (ALLEGRA) at an unspecified dose and frequency and ACETAMINOPHEN at an unspecified dose and frequency. At the time of the report, PRURITUS (Arm is very itchy), DIZZINESS (Light headed), ERYTHEMA (Arm is red), MYALGIA (Pain in her arm), RASH (Arm is like a rash) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were provided.
4/11/07-Tet. shot immediate pain. 2 hrs Later paralyzed w/pain could not move (L) arm for 2 days. (R) jaw soar-2 days. Arm pit swollen 2 day. 4/23/07-still very soar, cannot use (shooting/stab pain) Physical Ther. 5/11/07-still soar no strength X-Ray 5/12/07-chiro recommends MRI 5/15/07-MRI
This spontaneous report as received from a physician via a company representative refers to a 61 years old female. Her medical history included obesity. On an unspecified date, the patient developed redness and swelling at the injection site after receiving a second dose of PNEUMOVAX23 injection 25/0.5Y (lot# J006242, expiry date: 03-AUG-2014) (intramuscularly, dose and location unspecified) on 31-OCT-2013. Patient received the first dose of PNEUMOVAX23 on an unspecified date in 2005. Other suspect therapy included a dose of AFLURIA (lot# unspecified) (route, dose and location unspecified), on 31-OCT-2013. The reporter stated that the patient stated the injection site was infected, but this was not confirmed by the physician. Concomitant therapies included PROTONIX, levothyroxine sodium (manufacturer unknown), ASTEPRO, atenolol and vitamins (unspecified). Clindamycin as treatment was given for the events. The patient had sought medical attention via office visit. At the time of report, the outcome of the events was unknown. Additional information has been requested.
Patient stated that between 7-730pm (about 5 hours after injection)  his right arm became very painful with a severe muscle pain that he described as a "torn rotator cuff" pain and a numbness in his two middle fingers that came off and on afterwards. He took his Tylenol and morphine as prescribed for pre-existing conditions and the pain did not subside. He still had pain existing pain on 9/7/20 in the AM.
Redness and swelling at injection site and extensively involving lower arm over the period of several days worsening after injections.
mild fever , head ache ,fatigue ringing in right ear - sudden hearing loss in right ear treated at Urgent care on 4/16/22 with 60 mg of prednisone daily.  followed up on 4/18/22 with a audiology test and ENT doctor and noted event was triggered by Pfizer booster and to stay the coarse with prednisone therapy and to schedule another hearing test in one month.
Initially, she felt weak and warm. She complained of headache, tingling of fingers, "burning up". Then she broke out in reddened blotches on neck, chest and face. No difficult swallowing or respiratory distress noted. Did not lose consciousness, but eyes were rolling to top. Tx: Placed pt in Trendeleburg position after initial vital signs then vital signs repeated several times, as nurse continued to question and reassure pt until EMT's arrived. They took over from there. (Pt's mother works there too, so she was present throughout the incident). Pt called at home on 11/7/02. She said she developed a rash on her back that day and received Benadryl and MD suggested she have an allergy test done before a follow-up appointment.