chrisvoncsefalvay/vaers-outcomes huggingface dataset:
No adverse effects were reported; Multiple patients were administered improperly stored PROQUAD. Temperature -3 C; Information has been received from a medical assistant, concerning a patient of unknown age and gender. The patient's pertinent medical history, previous drug reactions/allergies, concurrent conditions and concomitant medication were not reported.      On 10-JUN-2019, the patient was vaccinated with improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # R030805, expiration date: 22-APR-2020, albumin status: rha) (dose number, anatomical location, dose and route of administration were not provided) for prophylaxis, that was reconstituted with sterile diluent (DILUENT MRK) (strength, dose, lot #, expiration date and route of administration were not provided) (it was not reported if the sterile diluent (DILUENT MRK) used had an excursion).   The Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) was stored at a temperature range of -9 degrees Celsius (°C) to 8°C (-3°C), for the time frame of 3 hours and 39 minutes. There was no previous temperature excursion and the call was because of a data logger. No adverse effects were reported.   This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1906USA008662: US-009507513-1906USA010323: US-009507513-1906USA008695: US-009507513-1906USA010325: US-009507513-1906USA010326: US-009507513-1906USA010327: US-009507513-1906USA010328: US-009507513-1906USA010329: US-009507513-1906USA010330: US-009507513-1906USA010331: US-009507513-1906USA008644: US-009507513-1906USA008643: US-009507513-1906USA008662:
While The Vaccine was being injected The material Seeped at the junction of the Needle and The Lauer Lock. The Lock Piece was Loose + rotated freely. This occurred twice on the Same Lot. Faulty Syringe
ITCHY, RED RAISED RASH NOTED BY PARENT ON BACK AND FRONT OF UPPER TRUNK AND BACK OF LEGS. NOTIFIED PCP WHO ADVISED ADMINISTERING BENADRYL Q 3 HRS THROUGHOUT THE NIGHT, MONITORING FOR INCREASE IN SEVERITY OF SYMPTOMS AND/OR RESPIRATORY DISTRESS. RASH PERSISTED FOR 2 DAYS WITHOUT COMPLICATIONS.
Patient admitted with shortness of breath and cough, he is a hemodialysis patient for past 13 years. Patient was found to be Hypoxic in ER and was admitted with Covid 19 Pneumonia. Patient completed remdesivir and taper dose prednisone, he was on BIPAP then 02 tapered to one liter NC. Slight elevation of troponin's but no chest chest pain, seen by cardiology, likely demand ischemia from Covid, Echo was done and showed EF of 45 percent. Patient was still weak and deconditioned and discharged to SNF for rehab prior to returning home
limping p vax; pt exp polyarthralgia, myalgia & rash;PE on 18JUL97 revealed poss coxsackie infect instead of allergic rxn;t101+;WBC 17.3;WBC 2.0; ASO <65;
Pt was administered 0.2 ml of FLUMIST in left nostril. Pt's mom reports no adverse reactions and she is doing well.
Patient received a COVID-19 vaccine and still got COVID-19 after that; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Patient received a COVID-19 vaccine and still got COVID-19 after that) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Patient received a COVID-19 vaccine and still got COVID-19 after that). At the time of the report, COVID-19 (Patient received a COVID-19 vaccine and still got COVID-19 after that) outcome was unknown.            No concomitant medications were reported. No treatment medications were reported.  Company comment: This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced nonserious unexpected AESI event of COVID 19, unspecified days after receiving a dose of mRNA-1273. It is reported that patient received a COVID-19 vaccine and still got COVID-19 after that, and the patient did not know if she received Moderna COVID-19 Vaccine. At the time of reporting, outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no medical history reported, who experienced nonserious unexpected AESI event of COVID 19, unspecified days after receiving a dose of mRNA-1273. It is reported that patient received a COVID-19 vaccine and still got COVID-19 after that, and the patient did not know if she received Moderna COVID-19 Vaccine. At the time of reporting, outcome of the event was unknown. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report.
This case was reported by a physician via sales rep and described the occurrence of diarrhea in a 2-month-old patient who received ROTARIX. On an unknown date, the patient received the 1st dose of ROTARIX. On an unknown date, less than a day after receiving ROTARIX, the patient experienced diarrhea. On an unknown date, the outcome of the diarrhea was recovered/resolved. It was unknown if the reporter considered the diarrhea to be related to ROTARIX. Additional details were provided as follows: The patient received a dose of ROTARIX during his 2 month vaccination visit and had diarrhea for 14 days following administration of the vaccine. The sales representative did not have any patient or vaccine information and believed that the patient was a male but was unsure. He also said that he believed the diarrhea began the same day after vaccination. The reporter was unsure of what other vaccines were given concomitantly.
Excessive wheezing not normally experienced. Headache, arm pain for over 2 weeks. On the 3rd day, I experienced extreme diarrhea 8-10 hours per day for 10 days. Diarrhea occurred about every 15 minutes for 8-10 hours each day for 10 days.  Double doses of Imodium or any other anti-diarrheal after each bowel movement had NO effect whatsoever. Vomiting in the morning after eating nothing  at all the previous day.  I called my NP to see if I should report this extreme diarrhea and the  nurse agreed.
This case was reported by a healthcare professional and described the occurrence of injection site reaction in a 5-year-old male subject who was vaccinated with KINRIX (GlaxoSmithKline). The subject had no medical history and no concomitant medication. On 17 March 2014 the subject received 1st dose of KINRIX (other, right thigh). Less than one week after vaccination with KINRIX, the subject experienced injection site reaction. No other event was reported. The subject was taken to an express care facility for treatment. At the time of reporting the outcome of the event was unspecified. The healthcare professional considered the event was probably related to vaccination with KINRIX.
Started hurting and then swelling.  Pain is deep in arm and hurts from shoulder to elbow.
Patient received his second dose of the Pfizer COVID vaccine around 10 am  in his left arm and noticed that later than evening his right forearm changed colors (purple/red).  The next day the color had returned to normal but his right hand and middle finger were swollen and purple/red in color.  He said he had applied a cream but does not remember what it was.  Reports no itching or pain.  Followed up with the patient a few days (6 days from administration of vaccine) later.  Patient reports they are feeling better and the swelling is gone and color is back to normal.  He only used ice and did not take any other medications.
At week 4, severe muscle pain in shoulders, arms, legs; Muscle weakness in legs and arms. Week 1 had no symptoms but aches started mildly in week 2, increasing in weeks 3 & 4 to the point that I could barely lift myself out of a chair; This is a spontaneous report from a contactable consumer, the patient. A 70-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6200) via an unspecified route of administration in the left arm on 18Feb2021 at 11:30 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. Medical history included melanoma surgery in 2008 and cholesterol. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included simvastatin and ezetimibe both for cholesterol from unknown date to 16Mar2021. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL9625) via an unspecified route of administration in the left arm on 28Jan2021 at 11:30 (at the age of 70-years-old) as a single dose for COVID-19 immunisation. On 01Mar2021 at 08:00, at week 4 the patient experienced severe muscle pain in shoulders, arms, legs, and muscle weakness in legs and arms. Week 1 had no symptoms but aches started mildly in week 2, increased in weeks 3 and 4 to the point that the patient could barely lift himself out of a chair. Patient talked with his Primary Care Physician on March 15 and suspected an interaction of the vaccine with the Simvastatin. The patient stopped taking both cholesterol medications on 16Mar2021. On 21Mar2021 patient felt a 25 percent reduction in pain. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether any therapeutic measures were taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events severe muscle pain in shoulders, arms, legs and muscle weakness in legs and arms, and could barely lift himself out of a chair was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
mild dyspepsia; bloating; loose stools; mild bilateral LBP; Fatigue; chills; body ache; low grade fever; This is a spontaneous report received from a contactable physician. A 50-years-old male patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: EL0140), via an unspecified route of administration, administered in arm left on 15Jan2021 at 12:00 as 2nd dose, single for COVID-19 immunization. Historical vaccine of BNT162B2 was given as first dose on 28Dec2020. The patient medical history was not reported. Concomitant medications included varicella zoster vaccine rge (SHINGRIX) taken for an unspecified indication from 14Dec2020 to an unspecified stop date, Escitalopram (ESCITALOPRAM), amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL), MVI, ergocalciferol (VIT D) and calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported. On 16Jan2021 at 11:00 patient experienced fatigue, chills, body ache and low-grade fever. Symptoms were significant enough that he remained in bed and missed planned activities. Second set of symptoms began on 06Feb2021. Patient says the second set of symptoms is most likely unrelated to his Pfizer COVID vaccine. However, sharing this might be helpful in the event other recipients describe similar symptoms and timing. Symptoms began at 03:00 AM as mild dyspepsia, bloating and loose stools and mild bilateral LBP. Pepcid relieved my dyspepsia which slowly resolved over 24 hours. The bloating has resolved but I have persistent loose stools and mild LBP. During this time patient have had no fever or symptoms of URI. All the symptoms have been mild and have not prevented him from participating in planned activities. Again, doubtful this is related to vaccine but curious to know if anyone else has reported this. The outcome of the events was not recovered with diarrhea and backpain whereas recovered for the other events.
It started with a dry, scratchy throat, congestion, runny nose, and sneezing. Eventually, I had a fever, fatigue, very achy, coughing, and COVID-19 fog. It lasted a week, most of the symptoms went away except the fatigue. I was still coughing when I talked. I went to a clinic to get a PCR test on the 25th of May, to confirm the results of the at home test on the 24th of May. The results were positive and I was referred to my doctor to get a prescription of PAXLOVID and take a lot of fluids and zinc. I did not take the PAXLOVID because I started to feel better, I am still quarantining due to still being positive for COVID-19 after 11 days of quarantining.
I was given the second dose this past Tuesday, 1/26/2021.  Tuesday night was rough, I felt feverish with headache, chills and body aches.  Wednesday morning I woke up with a headache and noticed a lump that was very tender at the vaccination area which was hot to the touch and red, I applied an ice pack.  Wednesday evening I started to feel a low grade fever again along with the body aches and chills.  Thursday my arm had a larger red swollen area, hot to touch and very tender as the day progressed I felt very fatigued and went to bed early.  This morning, my arm is still tender(not as tender as yesterday) but still red and swollen.
fever onset 7 days p/inject seen on 25JUL94 & had 4 days of fever so far;
Fever of 103 deg. F. four hours after the shot, swelling and redness at the injection site extending over 3 days from shoulder to elbow of the left arm. I was treated with intravenous antibiotics and given an MRI of the stomach to check for a stapleline leak, and to treat for a cellulitis in case the symptoms were not a vaccine reaction. The swelling and redness persisted for about a week. I am now affected by worsening joint pain in the left shoulder, and range of motion in the arm is limited.
Pt complained of redness around injection site. She was prescribed BACTRIM antibiotics. The redness was on her left arm.
Four days after taking vaccine the right eye was swollen shut and she had extreme head pain.  Pt went to Dr.  She was sent for an MRI.  This showed she had inflammation of the right lacrimal gland 5 X larger than it should be and prescribed prednisone.  She started w/ 60mg and the swelling was starting to go down but by the time she was down to taking 20mg the swelling returned, Dr. told her to start taking 60 mg again and referred her to Dr. on 4/28/21.  On 4/29/2021 he surgically removed the right lacrimal gland at Eye Surgery Center.  She went for FU appt.  The biopsy was not cancerous and surgery was success.  Pt no longer has headache and her vision is returning to normal.
Leg pain, headaches, blurred vision, dizziness, pain traveling all over the body( from head to toes lasting a couple seconds to hours). Ultra sounds on leg and abdomen, x-ray on knee, MRI- brain,  blood tests, urine test
Vaccine administered to left deltoid at 2020. Client was in observation room with daughter and reported to EMTs she was feeling pain to back of mid neck. EMT alerted RN's. RN arrived at 1643, client alert and oriented x4, sitting upright in chair, skin tone normal for ethnicity and no signs of flushing, able to speak in full sentences.  Per client, reported a sharp like pain and some warmth and numbness to mid  back neck around 2035 but reported was feeling better. Client reported no medical history, and no known allergies. Client reports taking apple cider vinegar supplements, collagen supplements, and Vitamin C supplements. RN assessed for sensory and motor function of neck and arms. Client able to move neck and arms and reported feeling stimuli. RN assessed for shortness of breath, chest pain, headache, and blurry vision but patient denied and reported no further symptoms and reported feeling better. Client reported she would wait a few more minutes in observations. Vitals at 2050: blood pressure 120/75, pulse 72, oxygen 96%.  At 2055 client reported pain has lowered and felt more of a sore feeling towards lower neck, had reported lower muscular back pain but denied pain radiation and no other symptoms.  EMT's stayed with client in observation room. At 2100 RN assessed client, client reported soreness to back of neck but reported feeling better. RN assessed back of neck per clients request and noted a raised red bump to back of neck. Client admitted to scratching area with nails. RN further assessed skin and back of neck for any signs and symptoms of hives or rashes, none was noted. RN offered to call EMS but patient declined and stated "I'm driving, I feel fine, can I go home?", client preferred to continue to monitor at home for any changes in condition. Per client, did not want to wait full 30 minutes of observation. RN 's educated client and daughter of ER precautions and following up with medical provider, client verbalized understanding. Client left facility with her daughter at 2108 with steady gait.
Constant tightness in chest.  Severe sweating spells with pale complexion and lightness in head lasting from 10 minutes to and hour.
has not received dose 2 yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 28th October 2021 (0.5 ml) at intramuscularly route).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 16-AUG-2022 Reporter's Comments:  The patient had not received dose 2 till the time of reporting. The information of lot number and injection site was not provided. The reporter did not consent to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Covid19 breakthrough.  1st vaccine received on 02/18/2021.  91 y/o with PMHx of AFIB, DM , HTN, HLD, CVA, OSA, COPD with home O2 at 3L NC, Lymphedema, Colostomy, OSA, Pulmonary HTN, GERD, Sarcoidosis presents to ED with c/o increasing SOB and cough.  O2 increased to 4L NC due to Dyspnea.  Afebrile. CXR with LLL atelectasis and consolidation with small moderated Left pleural effusion.  Treated with IV ABX and Steroids.
The pt. was at work sitting in a chair, when he began feeling ill with a headache. He was found to be diaphoretic, and slumped in a chair. He appeared to be paralyzed in the upper and lower extremities, only minimally able to move his head or speak. Pt. Was aware of his surroundings but only minimally able to respond. He was able to shake his head to confirm he had received his second dose of the vaccine after a band aid was noticed on his left upper arm. Due to his condition more information was unable to be obtained.
rash around the vaccination site; itchy; inflamed; 2 to 3 inch red spot on the arm around the injection site; Persistent spot; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Feb-2021 and was forwarded to Moderna on 17-Feb-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash around the vaccination site), PRURITUS (itchy), INFLAMMATION (inflamed), INJECTION SITE ERYTHEMA (2 to 3 inch red spot on the arm around the injection site) and VACCINATION SITE REACTION (Persistent spot) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included AMLODIPINE BESILATE, VALSARTAN (EXFORGE), NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), BUMETANIDE (BUMEX), MULTIVITAMIN & MINERAL, ASCORBIC ACID, BETA VULGARIS ROOT, IRON AMINO ACID CHELATE, ROSA CANINA FRUIT, RUBUS IDAEUS LEAF (IRON SUPPLEMENT WITH VIT C & HERBS) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE RASH (rash around the vaccination site), PRURITUS (itchy), INFLAMMATION (inflamed), INJECTION SITE ERYTHEMA (2 to 3 inch red spot on the arm around the injection site) and VACCINATION SITE REACTION (Persistent spot). At the time of the report, VACCINATION SITE RASH (rash around the vaccination site), PRURITUS (itchy), INFLAMMATION (inflamed), INJECTION SITE ERYTHEMA (2 to 3 inch red spot on the arm around the injection site) and VACCINATION SITE REACTION (Persistent spot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment details included BENADRYL AND CORTISONE CREAM.
no adverse effect; improperly stored PEDVAX HIB were administered/patient received one dose; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 10-APR-2019, the patient was vaccinated with an improperly stored dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, lot # R027320 with expiration date on 08-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The vaccine underwent the temperature excursion of above 47 (55.4) degrees Fahrenheit for 10 hours 45 minutes and below 36 (34.4) degrees Fahrenheit for 20 minutes. Digital Data Logger was involved in recording of the excursion. No previous temperature excursions were reported. No adverse effects were reported.  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-1904USA012969: US-009507513-1904USA012970: US-009507513-1904USA012971: US-009507513-1904USA012972: US-009507513-1904USA012973: US-009507513-1904USA012974: US-009507513-1904USA012975: US-009507513-1904USA012976: US-009507513-1904USA012977: US-009507513-1904USA012978: US-009507513-1904USA012979: US-009507513-1904USA012980: US-009507513-1904USA012981: US-009507513-1904USA012967: US-009507513-1904USA012968:
Fever, chills, inability to feel fingers on both hands lasting 12 hours. Now, 50% of the time in the morning, I still cannot feel my 4th and 5th fingers on both hands.
Patient reported covid arm (itching, redness) covering whole upper arm starting one week past first vaccination
Woke up Sunday morning with a slight headache at the base of skull and stiff neck. Have not had one day since without a headache or stiff neck.