chrisvoncsefalvay/vaers-outcomes huggingface dataset:
After the booster shot, I had body aches and a fever that lasted for about 12 hours. I felt really fatigued/weak and I had a headache that both lasted about 24 hours.
This spontaneous report as received from a nurse refers to a 25 year old male patient. The patient's concurrent conditions and medical history were unspecified by the reporter. The patient did not have any known drug reactions/allergies. On 09-OCT-1995, the patient was vaccinated with M-M-R II (strength, lot#, therapy type, dose number and route unspecified). On18-MAY-2016, the patient had blood titer drawn, and he was found to be negative for rubella antibodies. The patient's present status was unspecified (outcome unspecified). Product quality complaint (PQC) was not involved. Causality assessment was not provided by the reporter. No further information was provided. Additional information has been requested.
vision loss; Neuralgia; paresthesia; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. In or around October 2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dosage, route of administration and anatomical location were not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date, shortly after receiving zoster vaccine live (ZOSTAVAX) vaccine, the patient suffered shingles, neuralgia, paresthesia and vision loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).  Upon internal review, vision loss was determined to be a medically significant event.
Migraine headache lasting 12 hours, sensitive to light and sound, dizziness, nausea
Linchen Planus, very itchy and red patches, hives, Urticaria
Pediarix instead of IPV vaccine; 16 year old was administered Pediarix; This case was reported by a nurse via call center representative and described the occurrence of wrong vaccine administered in a 15-year-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number J7X44, expiry date 11th May 2023) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th March 2022, the patient received Pediarix (intramuscular) .5 ml and Pediarix Pre-Filled Syringe Device. On 17th March 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The 15 years old patient was administered Pediarix intramuscularly into her left arm when she was intended to receive IPV vaccine, which led to wrong vaccine administered and inappropriate age at vaccine administration.  No further information reported. Follow-up consent to contact was not asked.
Pt couldn't raise arm, was raised, hot, itchy rash about the size of a grapefruit, lasted 4 days and was painful.
Moderate chills; Difficulty sleeping; Mild headache; Mild injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 48-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3248), via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Medical history included COVID-19. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203), via an unspecified route of administration in the left arm on 03Mar2021 at 13:00 (at the age of 48-years-old), as a single dose for COVID-19 immunisation. Since the vaccination, the patient was not tested for COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. On 24Mar2021 at 12:00, the patient experienced mild injection site pain, also experienced the same on 25Mar2021. On 26Mar2021, the patient experienced moderate chills, difficulty sleeping and mild headache. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of vaccination site pain, chills, difficulty sleeping, headache and included treatment with TYLENOL. The clinical outcomes of the events vaccination site pain, chills, difficulty sleeping and headache were resolved in Mar2021.  No follow-up attempts are needed. No further information is expected.
Started to feel lightheaded an then got laid on the floor. Was given water and pretzels to eat. I asked the patient how she is doing and she stated that she is still shaky. I handed her the pretzels to finish eating and she drank some water. I asked the patient if she ate anything today and she stated that she did not. I asked how she was feeling after eating some more pretzels and she stated that it is helping but she is still shaky. I took the patient vitals at 10:25 am heart rate is 66, 02 100 and BP 105/71, again at 10:30 am heart rate 73, o2 100 and BP 101/69. I asked the patient how she was feeling. She stated that she was feeling better so i had her sit up the rest of the way and then stand up and then i made sure that she was not dizzy or light headed. The patient stated that she was back to her normal self. I released the patient home with mom and other sister at 10:35 am.
p/ pt recv vax approx 12 days later pt had chickenpox. MD saw pt in ofc & rpt pt had approx 20 eruptions on scalp, & had diffusely small areas some w/fluid; lesions are similar to bites &/or varicella
Patient further stated about 30 minutes after she received the booster she had blurred vision; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (Patient further stated about 30 minutes after she received the booster she had blurred vision) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030621A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VISION BLURRED (Patient further stated about 30 minutes after she received the booster she had blurred vision). At the time of the report, VISION BLURRED (Patient further stated about 30 minutes after she received the booster she had blurred vision) outcome was unknown.            No Concomitant product use was reported.  The patient reported that they received the Moderna booster on 04-Jan-2022. The patient further stated about 30 minutes after they received the booster, they had blurred vision.  No treatment information was provided.   This case was linked to MOD-2021-032391, MOD-2021-032445 (Patient Link).
Patient called on 9/17/17 and said their arm is red and warm from the injection site to their elbow. They are following up with their family doctor but wanted to let us know about the reaction.
ARM WAS SORE AT THE INJECTION SITE; This spontaneous report received from a patient via a company representative concerned a 74 year old of unspecified sex. 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. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced arm was sore at the injection site. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of arm was sore at the injection site was not reported. This report was non-serious.
Painful arm; Chills; Nausea; Headache; Fatigue; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 11-Feb-2021 and was forwarded to Moderna on 12-Feb-2021.    This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (Painful arm), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030M20A and 012620A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in May 2020.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced PAIN IN EXTREMITY (Painful arm), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, PAIN IN EXTREMITY (Painful arm), CHILLS (Chills), NAUSEA (Nausea), HEADACHE (Headache) and FATIGUE (Fatigue) had not resolved.            No relevant concomitant medications reported.  No treatment information was provided.  Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable
patient had 103 degree fever; was 'sick for a week; This is a spontaneous report from a non-contactable consumer. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. Medical history included: patient had covid-19 approximately 1 month prior to shot. The patient concomitant medications were not reported.  On an unspecified date, after the first dose, patient had 103-degree fever and was sick for a week. He had COVID approximately 1 month prior to shot and was unaware of any recommendations to wait a period of time before vaccination. The outcome of events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sore arm that lasted 10 days, moderate flu-like symptoms that persisted 3 weeks. Pt got PREVNAR and FLUZONE injected the same day. Claims several others he knows who got the same combination on the same day experienced similar symptoms.
Sneezing; Headache; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (Sneezing) and HEADACHE (Headache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) injection for Psoriatic arthritis and Plaque psoriasis.    No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) at an unspecified dose. On an unknown date, the patient experienced SNEEZING (Sneezing) and HEADACHE (Headache). At the time of the report, SNEEZING (Sneezing) and HEADACHE (Headache) had resolved.            This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.  No concomitant medication was provided.  No treatment medication was provided. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial.   This case was linked to MOD-2021-623781, MOD-2021-623784, MOD-2021-623781 (Patient Link).
Left deltoid region started to get itchy, red, hot, swollen, and a rash over the entire area. Started exactly 1 week after the first vaccine was given. On Friday, March 12 symptoms began in the late afternoon. On Saturday am, pain was about a 6/10 and the area was extremely swollen and hot to the touch.  Treated with  Benadryl 50 mg and Advil 600 mg. On Sunday, March 14, paid had decreased but rash had spread. Swelling was very diminished. Monday, March 15, all pain and swelling are gone. Rash is still present. It is moving lower down the arm. (gone from the upper region)
1st dose received Pfizer;  Moderna was incorrectly administer at 3 weeks for the 2nd dose
A ZOSTAVAX vaccine was given on 12/9/14 in the left arm. Patient reported that on 12/11/14 she noticed that the sight was red and a "little itchy". BENADRYL was recommended and to report if it gets worse.
There are no adverse effects known at this time.  Patients who came on 2/11/2021 were due back on 3/11/2021. The  system was down and a reminder email could not be sent. We asked the  help desk to for a list of patients from 2/11/2021 to issue a reminder to patients.  An email was sent out to all patients on the list. Patient's wife  received the email. She called our office to ask about the 2nd dose email and a time to come in for the vaccine. Representative from our office registered patient  from the information we received on the spreadsheet from the help desk. She dod not see that the report listed patient as a waitlist patient and was registeredfor his 2nd dose at the clinic for a 2nd dose of Moderna. Patient received a dose of Moderna on 3/11/2021 and upon checking out with the physician onsite it was discovered that he had not received his 1st dose of Moderna at our office on 2/11/2021 but had received his 1st COVID-19 vaccine on 2/23/2021 at a County site and the vaccine he received was Pfizer. Patient received a mixed series within 16 days of each other. He has no known adverse effects at his time. We spoke with the patient and his wife at the close of our clinic explained the error which occurred and let them know we would be filing a report with VAERS. We have made changes to our clinic process and have 3 check points and reviews of vaccination cards in additional to our normal process for 2nd dose patients.
General adverse events flu-like symptoms / after the first dose; Feeling tired / after the first dose; Feverish after the first dose; Doctor diagnosed her with cellulitis / first dose; Pain / first dose; Redness / first dose; Hot skin / first dose; Swelling as big as a baseball / that required medical attention; Roundish circle over the site of the injection / first dose; This case was reported by a consumer via market research programs and described the occurrence of cellulitis in a 53-year-old female patient who received Herpes zoster (Hz/su + AS01B) for prophylaxis.   In March 2019, the patient received the 1st dose of Hz/su + AS01B. In March 2019, less than a day after receiving Hz/su + AS01B, the patient experienced cellulitis (serious criteria GSK medically significant), pain, erythema, skin warm and swelling. On an unknown date, the patient experienced injection site discoloration, influenza-like symptoms, tiredness and fever. The subject was treated with antibiotics nos (Antibiotics Therapy (Unknown)). On an unknown date, the outcome of the cellulitis, pain, erythema, skin warm, swelling, influenza-like symptoms, tiredness and fever were unknown and the outcome of the injection site discoloration was recovered/resolved.   It was unknown if the reporter considered the cellulitis, injection site discoloration, pain, erythema, skin warm, swelling, influenza-like symptoms, tiredness and fever to be related to Hz/su + AS01B.  Additional details were reported as follows: The age at vaccination was not reported however it could be 52 or 53 year. The patient had a local adverse events pain, red ness and hot skin on day of vaccination. The patient had swelling as big as baseball a day after vaccination and required medical attention. The doctor dignosed it as cellulitis and provided antibiotics that reduced swelling in 1or 2 days. The patient also had roundish circle over the site of injection that stayed for 1 week. The patient also had general adverse event flu like symptoms such as feeling tired and feverish. For tolerance with 2nd dose refer the case US2021AMR111210.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR111210:Same reporter,same patient 2nd dose
SEREVE STROKE, SPENT 4 DAYS IN THE HOSPITAL, IM VERY TIRED ALL THE TIME , CANT CONCENTRATE ON THINGS, CANT REMEMEBER ANYTHING, RIGHT EYE IS DROOPY
INAPPROPRIATE SCHEDULE OF VACCINE ADMINISTRATION; This spontaneous report received from a health care professional concerned a male of unspecified age.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.  The patient was previously treated with covid-19 vaccine ad26. cov2. s  (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 15-OCT-2021 for prophylactic vaccination. (Dose number in series 1)  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 22-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. (Dose number in series 2)  On 22-OCT-2021, the patient experienced inappropriate schedule of vaccine administration.(Dose number in series 2)  The action taken with covid-19 vaccine ad26.cov2.s was not applicable.  The outcome of inappropriate schedule of vaccine administration was not reported.  This report was non-serious.
Blood glucose has registered at increased levels and has become less manageable; This is a spontaneous report from a contactable consumer, the patient. A 57-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6203) via an unspecified route of administration in the left arm on 02Mar2021 at 10:15 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history included type II diabetes mellitus, hypertension and cholesterol. The patient had no known allergies to medications, food or other products. The patient received unspecified concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot no: EM 9810) via an unspecified route of administration in the left arm on 08Feb2021 at 13:45 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 02Mar2021 at 11:00 from the time of the vaccination until present, the patient blood glucose had registered at increased levels and had become less manageable. It was reported that there had been major increased levels after rest/fasting during the night. The patient had been monitoring everything closely and in the past 30 days have an average of blood glucose was 203, the highest fasting reading blood glucose was 353. The patient blood glucose lowest and former more normal reading was 107. It was stated that the patient was taking all this data to next doctor visit on 15Apr to assess the situation. No therapeutic measures were taken as a result of reported event. The events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. On an unknown date, the patient underwent blood glucose and the result was 203, 353 and 107 (Unspecified units). The clinical outcome of the event blood glucose had registered at increased levels was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Patient presented to the ED on 4/27/2021 for malignant ascites. Patient presented to the ED and was subsequently hospitalized on 5/3/2021 for small bowel obstruction.  These visits are within 6 weeks of receiving COVID vaccination.
Received Tdap left deltoid 1-2--10 at approximately 4:45pm. At approx 6-6:30 developed achy pain left arm. 1-21-10 woke up with numbness and pain left arm with movement. Pain radiates from arm down to hand, finger numb and hypersensitive. No previous vaccine reaction. Placed on Neurotin and Motrin with a neurology referral. RTC 1-22-10 Continued to have arm left pain, Neurotin allowed patient to sleep, left arm swelling using sling, arm not as cold.
Patient is a delightful 27-year-old female, patient of the Dr, who presents in the clinic today accompanied by her mom, due to concerns about abdominal pain and not feeling well for the past 24 hours.  They note problems with the patient controlling her urine as well as lower abdominal pain and a temperature of 99.9 degrees.  When sitting on the toilet earlier today, the patient complained of pain when she was going to the bathroom.  Her mom notes that she had a soft brown bowel movement today.  She denies any bloody or black stools.  She denies any vomiting.  No nausea.  The patient herself is a poor historian secondary to history of Down syndrome.  Her last menstrual period ended about seven days ago.  She has been drinking okay but is not eating as much since her symptoms started.  She does complain of some mild low back pain as well.  She denies cough, shortness of breath, or wheezing.  No sinus pain, pressure, ear pain, or sore throat. Patient is a pleasant 27-year-old female patient of the Dr., who has Down Syndrome, who presents in the clinic today accompanied by her mom, in followup on her visit yesterday.  Patient was seen yesterday secondary to a fever and generalized not feeling well.  She is poor historian given her above history.  We did obtain labs yesterday including a CBC with a white count of 18.4.  Neutrophils were at 12.7.  Lymphocytes at 4.5. CRP  was found to be elevated at 7.6.  Metabolic profile was unremarkable.  Urinalysis was unremarkable.  Urine culture is currently pending.  In addition, PA and lateral chest x-ray was obtained revealing cardiomegaly with no acute findings, as well as a CT of the abdomen and pelvis was obtained and this revealed new small to moderate partially visualized pericardial effusion, normal appendix, with no acute findings in the abdomen.  Blood cultures are currently pending times two.     She presents today for followup.  She at this time is overall doing very well.  Her mom does note that her appetite is slightly down, but she has not had any fevers, chills, night sweats, no nausea or vomiting.  She has been drinking normally.  Patient seemed a little more sad and down today in comparison to yesterday.  She denies any concerning rashes or other concerns.   Patient's mom provides the rest of the history.    She then presented to ER for positive BC-later determined to be a contaminant.  She was found to have a pericardial effusion which has persisted until at least August.  because she is not very verbal, we do not think she has any symptoms.