chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt explained on Covid-19 consent form that she has syncope when seeing a needle. She explained she has an intense fear of needles and has fainted in the past when getting vaccinations. She also explained that she has anxiety. She explained that when she faints it looks like a seizure but it is not. When pt was given shot she was responsive during the needle going in.  She was in a seated position. We talked the entire time of administration. After putting the the bandage on her right arm she explained she felt sick(about 40 seconds after injection).  She was still responsive for about two minutes then she fainted and her body shook about two times.  My coworker and I got her on the ground, she was still responsive enough to ask for a cup of water. Which we gave her, she then went unresponsive for 20 seconds and spilled the water. After this we sat with her on the ground for another 5 minutes and she said she was fine. We helped her to a seated position.  We then made her wait  another 30 minutes in our waiting area. She assured us she was fine and reiterated that this has happened before in the past anytime a needle was involved.  On 5/2/2021 she was contacted and she explained she looked a little pale throughout the day of vaccination, but feels fine now and just has a sore arm.
fever, headache,ear aches, constipated, head cold, loss of appetite and no energy sick for 5 days getting slowly better
Swelling in throat, tongue, face and then eyes.  fast heart rate.  rash on face and dizziness and weakness Give prednisone and benydrl in IV and took 1 50mg prednisone at home.    Weakness for 3 days and swelling has gone down
Vaccine administered on 2/17/12 patient came in on 2/19/12 and showed me a local reaction (wheal & flare) of about 2" x 3".
She got scared; Did not get her second vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FEAR (She got scared) and PRODUCT DOSE OMISSION ISSUE (Did not get her second vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEAR (She got scared) and PRODUCT DOSE OMISSION ISSUE (Did not get her second vaccine). At the time of the report, FEAR (She got scared) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not get her second vaccine) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment were reported.   Reporter did not allow further contact
10/4/2022-Presents to ED via EMS, with reports of AMS, only responsive to painful stimuli. Ordered ceftriaxone, UTI. Trop peaked at 0.144 consistent with a Type 2 NSTEMI, recieved asa and on Heparin drip. Covid - test. Recent admission 9/11-9/23/2022 for acute hypoxic resp failure PNA. VSS 02 94% on RA. CXR-bibasilar airspace disease. Admit metabolic encephalopathy in setting of UTI. 10/7/2022-BP elevated 181/66 Hydralazine added. Desat 85% 4L via NC placed. Ceftriaxone changed to Unasyn, to cover for aspiration. 10/10/2022-UC yeast and VRE. restart oxybutin and start linezolid and  fluconazole. Now covid +. 10/12/2022- Continue on bumex, isodil and Procardia. On RA VSS. CXR-b/l pulm infiltrates. Reanla dysfunction 10/12/2022- does not permit to use remdesivir or baricitinib.  10/13/2022- O2 increased to 6L nc after desat of 87%. Unasyn changed to Zosyn. Dexamethasone started. 10/14/2022-O2 increased to 8L NC.   10/15/2022- o2 increased to 15 L NRB, made palliative. Time of death 2056.
He received dose #1 of the Pfizer COVID vaccine on April 11th in his left arm.  Within a week or so he said that his fingers started to swell.  This progressed up his left arm and started to affect his legs around the same time symmetrically.  He received a 2nd dose 4 weeks later only to see the symmetrical swelling of arms and legs hands and feet increase. He has seen his PCP who checked labs and chest x-rays and assured him that there did not appear to be any organ injury or evidence of congestive heart failure. He says he has gained about 60-80 lb and is having trouble moving and breathing.  He has a cough which also started around the same time.  He attributes his relatively hoarse voice to this cough. He was admitted to a Medical Center on 7/29/21 for leg edema and shortness of breath leading to difficulty walking and leakage of fluid from his calves. He was also diagnosed with left lower extremity cellulitis and started on amoxicillin/clavulanate. After consultation by ID, rheumatology, and cardiology he was diagnosed with anasarca with unknown cause and temporal association with COVID vaccination. He was treated with IV and PO furosemide with significant improvement in the edema. Workup for autoimmune disease and scleroderma were negative.
Patient experienced slight dizziness, headache, and palpitations. Blood pressure was slightly high.
DISCOMFORT IN CHEST; SLIGHT COUGH; EXTREME FATIGUE FOR 2 WEEKS; FELT OFF; This spontaneous report received from a patient 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 received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On MAY-2021, the subject experienced felt off. On MAY-2021, the subject experienced extreme fatigue for 2 weeks. On JUN-2021, the subject experienced discomfort in chest. On JUN-2021, the subject experienced slight cough. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from extreme fatigue for 2 weeks, and was recovering from felt off, discomfort in chest, and slight cough. This report was non-serious.
Had a right sided headache mostly affecting the right eye.  It lasted 4 days until treatment.  Reminded me of the same pain I had when 2 years ago I had shingles around my Right eye.  Also after a car accident 5/2020, I had similar headaches and eye pain. The thought being it seemed maybe the viral load with the  injection was similar to the viral shingles incident?
This case was reported by a nurse via call center representative and described the occurrence of vomiting in a infant patient who received ROTARIX. On an unknown date, the patient received ROTARIX (oral). On an unknown date, less than a year after receiving ROTARIX, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related to ROTARIX. Additional details were reported as follows: The age at vaccination was not reported. The healthcare professional reported that the patient received ROTARIX and vomit afterwards. No additional information was provided.
This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle Ache) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-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 03-Feb-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle Ache). In February 2021, CHILLS (Chills), PYREXIA (Fever), HEADACHE (Headache) and MYALGIA (Muscle Ache) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment information were not provided. Action taken with mRNA-1273 in response to the event was not applicable.
Information has been received from a registered nurse concerning a male in his 40's with allergic reaction to unnamed antibiotics who was vaccinated with MERUVAX II (manufacturer unspecified) on a sugar cube as a child. When he was in his 40's he developed Multiple Sclerosis. He was given interferon for the Multiple Sclerosis but it made him sick and he had a fever. It was discontinued and started on COPAXONE injections but he had a fever and ulcerative colitis, hospitalized for a week with bloody stools. He was now 51 years and was able to walk with a cane but fatigues easily. The doctor felt Multiple Sclerosis was due to the rubella vaccine. At the time of the reporting, the patient's status was unknown. Upon internal review, Multiple Sclerosis was considered to be an other important medical event. This is one of several reports received from the same source. Additional information has been requested.
By mid afternoon my arm had swollen and was hot. By morning 9/7, it was 3 x its normal size, hot and very sore from shoulder to elbow and I awoke with chills, fever, sweating, nausea, blurred vision and feeling of faintness. When I arrived at the ER my blood pressure was abnormally low and my body temperature was < 96 degrees
This spontaneous report was received from a licensed practical nurse and refers to multiple unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, multiple unspecified patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (lot # N030987), expiration date on 15-MAY-2019 (dose, frequency, route of administration not reported) or with improperly stored GARDASIL 9 (lot N020353 with expiration date on 28-APR-2020) or (lot N021572 with expiration date on 01-MAY-2020) or (lot N022728 with expiration date on 31-MAY-2020) (dose, frequency, route of administration not reported) for prophylaxis. It was stated that the vaccine PNEUMOVAX 23 underwent a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 2 hours 8 minutes; no previous temperature excursion was performed. It was stated that the vaccines GARDASIL 9 underwent a temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 2 hours 16 minutes with previous temperature excursion of 47 degrees Fahrenheit to 77 degrees Fahrenheit for 56 hours 38 minutes. No adverse effects were reported. This is a non-valid case due to lack of patient identifier.
Localized cellulitis 2 days after influenza vaccine.  Red, hot to touch, four inch area on L deltoid.
Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In or around February 2010, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately 2010 [reported as shortly after receiving ZOSTAVAX], the patient suffered from shingles. As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experienced mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient 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 consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the shingles was considered to be not recovered. Shingles was considered to be disabling. Additional information has been requested.
Started with headache about 20 minutes after shot, then  gradually over the next 45 minutes itchy & puffy upper lip, cheeks, eyelids, tightness at back of mouth.  all cleared up about 45 minutes after onset so all lasted about 1.5 hours
On 4/5/02, developed red macular rash with raised yellow vesicles at the injection site consistent with varicella lesions. Hasn't been seen for follow-up yet.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received expired dose beyond expiratory date 09OCT2021) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received expired dose beyond expiratory date 09OCT2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (The patient received expired dose beyond expiratory date 09OCT2021) outcome was unknown. Not Provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported. On 21-Sep- 2021, vial was initially stored in the refrigerator. No temperature excursions was noted and patient did not experience any adverse event.  Treatment medications were not reported.
Extreme fatigue; This is a spontaneous report from a contactable consumer (patient). This patient of unspecified age and gender received BNT162B2 (PFIZER BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. After the vaccine on an unspecified date the patient experienced extreme fatigue. The outcome of extreme fatigue was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
TERRIBLE TREMORS; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced terrible tremors. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of terrible tremors was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure since case assessed as non-serious.
pt recv vax 11NOV97 & 6hr p/vax pt exp a very swollen arm;the next day pt exp chest pain, tremendous swelling in the arm over the deltoid & shoulder area, tenderness & myalgia;
4x6cm area on right deltoid of erythema and induration, noted about 24-36 hours after vaccine. Ice applied.
Abscess at site of vaccination which appeared about one week after.  Right shoulder/deltoid.
sore arms; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received vaccine a few years ago).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. Post vaccination with Shingrix the patient had sore arms for several days. The patient had to revisit the pharmacy several times before she could get her second shot. This is 1 of the 3 cases reported by the same reporter for the same suspect.
Adverse Event: Sudden cardiac arrest, fatal arrhythmia; Treatment: successful resuscitative efforts; Outcome: AICD placement
This spontaneous report was received from a Certified Medical Assistant and refers to a patient of unknown age. No information regarding the patient's medical history and concurrent conditions was provided. On 09-NOV-2017, the patient was vaccinated with a dose of VARIVAX injection (dose, route of administration, lot number and expiration date were not reported) and subsequently, 27 days later, on 06-DEC-2017, with a 0.5 ml dose of M-M-R II subcutaneous injection, lot # N013867 with expiration date on 04-MAY-2019. The dose of M-M-R II was reconstituted with sterile diluent (MERCK STERILE DILUENT). No adverse effects were reported.
Started having deltoid pain about 1100am, then about 2200 that night was having right armpit pain and deltoid pain, took Ibuprofen 600 mg pO and glass of wine, and then didn't sleep well, states the armpit was swollen and and the whole upper arm was swollen elbow to shoulder, achy joints and generalized weakness, armpit pain and sweating.  Took multiple times during the day, Ibuprofen 800mg three times that day and didn't touch the pain at all.  Put ice to arm and then put heat to right arm. Then on 9/24 didn't sleep well that night.  Then on 9/25, the muscle pain to right deltoid was better, the armpit pain was the same, weakness, sweaty.  As day progressed felt better.  States today 9/25 has headache and achy joints in wrists, elbows, and knees, no fever today.  Took Ibuprofen all day Sunday and this morning. Has some swelling to right arm and pain to armpit today, rates 5/10. Given Tylenol 1000 mg po today for discomfort. States did not sleep well last night.
This is in follow-up to report(s) previously submitted on 8/14/2008. Information has been received from a registered nurse concerning a 11 year old female who on 11-JUL-2008 was vaccinated with a dose of GARDASIL and MENACTRA. On 12-JUL-2008, the patient experienced fever and rash all over her body. The patient was also given a TB test On 10-JUL-2008 one day prior to getting GARDASIL, on 10-JUL-2008. No laboratory test was performed. The patient outcome was not reported. The patient sought medical attention by contacting the office. Additional information has been requested.
vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
Headache; Fatigue; Nausea; Vomiting; Chills; Fever; This is a spontaneous report from a contactable consumer, the patient. A 39-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 08Apr2021 at 10:45 (at the age of 39-years-old), as a single dose for COVID-19 immunisation. Medical history included penicillin allergy. The patient did not receive any other medications in two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 18Mar2021 at 09:30 (at the age of 39-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 vaccination. On 08Apr2021 at 14:00, the patient experienced headache, fatigue, nausea, vomiting, chills and fever. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events headache, fatigue, nausea, vomiting, chills and fever were resolved on an unknown date in Apr2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
10 hours later after received vaccine developed Left arm pain . During the night wake up due to severe left axillary pain irradiated to left scapula, left breast, also has adenopathy, bone ache and fatigue. Taken acetaminophen
Shortness of breath while exercising on 4/24/21, progressively got worse.  Went to ER on 5/5/21 where they discovered numerous DVTs in right leg and Pulmonary Embolisms in both lobes of lungs.  Heparin administered in ER and admitted for two nights to regulate dosage and to have echo cardiogram performed which also showed a thrombus in right atrium of heart.  Doctors said no other underlying cause of clotting and attributed it to the vaccine.  Now on maintenance course of Xarelto.
PT GOT HER FLUSHOT AND PNEUMOVAX ON THE SAME ARM ON 96/19, PER PT REQUEST FOR LEFT.  THE NEXT DAY AFTER THE INJECTION, THE INJECTION SITE WASN'T AS RED BUT THEN LOWER PART OF THE ARM WAS.  WHEN SHE CAME TODAY, 9/8/19,  IT FELT WARM TO THE TOUCH, A BIT SWOLLEN, AND A BIT ITCHY.  PT THINKS THAT IT WAS GETTING REDDER.  PT HAS BEEN TAKING BENADRYL BID (FOR ALLERGIES) DAILY.  ALSO ADVISED HER TO TAKE TYLENOL AND USE COLD COMPRESS IF IT HELPS ANY.  SHE WILL SEE HER DERMATOLOGIST TOMORROW 9/89/19  AND LET US KNOW.
immediately had swollen lymphnodes on neck, groin, collar bone, etc.  After many tests, blood work, doctor's appointments, bone marrow biopsy, diagnosed with T cell ALL Acute lymphoblastic leukemia
Information has been received from a health professional concerning a 4 year old male who on 10/12/2001 was vaccinated with varicella vaccine. On 10/19/2001, the pt developed approximately 10-12 vesicular lesions. No other symptoms were reported. Unspecified medical attention was sought. No further info is available.
on same day as 2nd injection I began to have flu like symptoms and a fever of 103-104 this continued for 4 days until 3/9/21.  Since then my temperature seldom goes below 99 degrees and everyday I wake up fatigued and aching.  I did not have these symptoms prior to the injections.  It really makes it hard to get through the day or accomplish normal physical tasks.  I want to know when I can expect to feel better.  I really hope someone reads this message.