chrisvoncsefalvay/vaers-outcomes huggingface dataset:
flu; in a coma for 10 days sick; total kidney failure; sepsis; gangrene; respiratory distress syndrome; Post-traumatic stress disorder; Sleep problems; Initial information was received on 29-Sep-2021 regarding an unsolicited valid Social Media serious case received from a Consumer.  This case involves a 46-year-old patient (unknown gender) who experienced total kidney failure (Renal failure), sepsis, gangrene and respiratory distress syndrome (Acute respiratory distress syndrome) all caused by the flu (influenza), and was in a coma for 10 days sick (coma) requiring Total life support. Patient still has Post-traumatic stress disorder and Sleep problems (sleep disorder) for 4 years later after receiving INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE].  The patient reported that he had no health problems before the reported events.  Patient's medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed  experienced total kidney failure (Renal failure), sepsis, gangrene and respiratory distress syndrome (Acute respiratory distress syndrome) all caused by the flu (influenza), and was in a coma for 10 days sick (coma) requiring Total life support (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. These events were assessed as medically significant. The patient was hospitalized for these events and were life-threatening event.  Patient also reported that he was out of work for 5 months.   On an unknown date the patient developed Post-traumatic stress disorder and Sleep problems (sleep disorder) (unknown latency) following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED and continues to have it 4 years later.  It is unknown if the patient experienced any additional symptoms/events.  Other relevant tests were not reported.  It was not reported if the patient received any corrective treatment.  At the time of report, the outcome of event was unknown.  Information on the batch number was requested.; Sender's Comments: This poorly documented social media case concerns a 46-year-old patient (unknown gender)  who experienced total kidney failure (Renal failure), sepsis, gangrene and respiratory distress syndrome (Acute respiratory distress syndrome) all caused by the flu (influenza), and was in a coma for 10 days sick (coma) requiring Total life support. Patient still has Post-traumatic stress disorder and Sleep problems for 4 years later (unknown latency) after vaccination with FLUZONE. Further information regarding additional medical history, concomitant medications, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
local allergic rxn w/superimposed cellulitis, tx w/Levaguin, hydrocortisone cream, APAp;referred to PCP;DPH added;
No additional AE; Nurse calling with a medical information question. HCP states that 2 pediatric (twin) patients were given an extra dose of MMR-II and VARIVAX.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 28-JUN-2023, the patient was vaccinated with extra dose (third dose) of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot # W039697, expiration date: 13-DEC-2024, administered subcutaneously for prophylaxis (strength, lot #, and expiry date were not provided); and  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Extra dose administered). No additional adverse events were reported.  This is one of two reports received from the same reporter.; Sender's Comments:  US-009507513-2307USA000029:
Starting around 6 pm I started having aches and chills. At about 11 pm, those chills and aches got more severe and I had a fever of 101 degrees for about two hours.
Redness, warm to the touch - starting about 3 fingers from injection site middle of arm rotating to inner arm. Patient has never had a reaction to Flu
On 11/26/99, the pt developed apruritic varicella-like rash that consisted of approximately 20 lesions on her face, trunk, back of legs and neck. The pt was seen by a physician. The pt was removed from work until the lesions crusted over. It is reported that on 12/2/99, the pt recovered.
During event, about 20 minutes after client received ,Ems noticed client pressing on her chest, client stated she was  having pressure on her chest and pain was not radiating,vs was table ,ice packs was placed on, client started she has hx cardiac issues she doesn't know. After 10 minutes she started she was feeling better and pain was gone. She declined ems to be called. She left with family and she started she was feeling better.
Severe tiredness, fever of 100 (97.5 is my normal), lack of appetite, lethargy
none Medical records state dehydration, chest pain, decresed coag time,anemia, asthenia, diarrhea, myalgia. msv
Fell and broke neck; Fell and broke neck; more than 35 days from 1st vaccination; This spontaneous case was reported by a consumer and describes the occurrence of NECK INJURY (Fell and broke neck) and FALL (Fell and broke neck) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced NECK INJURY (Fell and broke neck) (seriousness criterion hospitalization prolonged), FALL (Fell and broke neck) (seriousness criterion hospitalization prolonged) and PRODUCT DOSE OMISSION ISSUE (more than 35 days from 1st vaccination). At the time of the report, NECK INJURY (Fell and broke neck) and FALL (Fell and broke neck) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (more than 35 days from 1st vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.  Based on reporter's causality  the event is assessed as unlikely related to mRNA-1273. This report also refers to a case of Product dose omission  with no associated AEs, causality is Not applicable.; Sender's Comments: Based on reporter's causality  the event is assessed as unlikely related to mRNA-1273. This report also refers to a case of Product dose omission  with no associated AEs, causality is Not applicable.
no aditional AE; freezer underwent an excursion and they did not realize the excursion until later/temperature excursion for VARIVAX and PROQUAD/ VARIVAX and PROQUAD may have been administered to multiple patients; This spontaneous report has been received from a nurse, concerning a 12-month-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies, and concomitant medications were not provided.  On 15-MAY-2023, the reporter's freezer underwent a temperature excursion; in which varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (rHA) were stored. On that same day, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # W035466 and W017567 with following expiration dates 06-MAY-2024 and 29-NOV-2023, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided).  Other suspect therapies included varicella virus vaccine live (oka/merck) (VARIVAX) lot # U039723 and W031812   with following expirations dates 15-DEC-2023 and 05-OCT-2024, 0.5 milliliter for prophylaxis (dose number and route of administration were not provided) (product storage error and no adverse event).; Sender's Comments:  US-009507513-2306USA004082: US-009507513-2306USA004088: US-009507513-2306USA004089: US-009507513-2306USA004090: US-009507513-2306USA004087: US-009507513-2306USA004086: US-009507513-2305USA007959: US-009507513-2306USA004083: US-009507513-2306USA004084:
Redness, swelling, feverish, and tenderness softball size under arm of injection site.
I did not have an adverse reaction to the vaccine. In May 2022, I began having a strong response to the pollen that developed in our area. I was very dizzy and had problems keeping my balance. I was already taking CLARITIN. About two weeks later, I had a cold that turned to an upper respiratory infection. As of today, it is an ongoing problem.
12/31/2021 dull headaches throughout the day, tiredness.  1/1/2022 severe headache, slept most of the day, no appetite.  1/2/2022 reaction to injection site (redness from near the shoulder to close to the elbow, warm, and itchy).
muscles locked up . Could not move to sit up . took 35 minutes to get out of be
Swelling of face and neck, hotness of face and neck, rapid heartbeat, extreme dizziness and lightheaded.  Symptoms started 15 minutes after injection.  Dizziness and lightheaded lasted duration of the day.  Rapid heartbeat lasted approximately 3 minutes.  Swelling of face lasted approximately 6 hours.  Hotness of face and neck lasted approximately 3 hours.
SLEEPYHEAD FOR 3 DAYS; This spontaneous report received from a patient via a company representative 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: UNKNOWN) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. As per procedure no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the subject experienced sleepyhead for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepyhead for 3 days. This report was non-serious.
Horrible lower  back pain after first shot 7 days just bent over to pick a small item off floor. Some history of back pain but this was bad!! Horrible knee pain when picking up an item off the floor next day after shot.  No history of knee pain.
Shingles vaccine-Fever (99.9) dizziness, muscle pain, tired.
Information has been received from a pharmacist concerning a 71 year old female with no medical history or allergies, who on 12-NOV-2007 was vaccinated IM with a 0.5 ml dose of pneumococcal 23v polysaccharide vaccine (lot#658673/0990U). There was no concomitant medication. On 12-NOV-2007 the patient experienced persistent pain in the shoulder and weakness in his arm. Unspecified medical attention was sought. No diagnostic laboratory studies were performed. The patient's persistent pain in the shoulder and weakness in arm persisted. No product quality complaint was involved. Additional information has been requested.
Really dizzy; This is a spontaneous report from a contactable consumer (wife). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 14Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On 15Jan2021 the patient experienced the event really dizzy. The reporter called to ask if dizziness was a side effect of the vaccine. The clinical outcome of the event, really dizzy, was unknown.   The lot number for vaccine BNT162B2, was not provided and will be requested during follow-up.
1st and 2nd hurt really bad at injection site/her arm was so sore/whole arm hurt; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 76-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose 1, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "1st and 2nd hurt really bad at injection site/her arm was so sore/whole arm hurt".  Additional information: Caller was going to have surgery on her lungs and wants to know if she should have the Pfizer covid vaccine 2023-24 formula before or after she has surgery. She stated she had 4 covid vaccines in the past, all Pfizer and with the first two vaccines, they pinched up her skin to give the vaccine and it hurt really bad. She thought that's why her arm was so sore and thought she would pass it on if it would help. Reaction: 1st and 2nd hurt really bad at injection site. The 1st and 2nd hurt really bad at injection site, but she noticed it was when nurse pinched up skin to give injection. The 3rd and 4th she asked them not to do that and it didn't hurt.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300309738 same patient, vaccine, event with different dose;US-PFIZER INC-202300309740 same reporter, vaccine, different patient and event;
Severe itching, redness, swelling, and mass at injection site. Continues to get worse.
Patient injected with (2) expired pediatric doses. Patient is aware and complies to make an appt at local H. dept to receive an adult hepatitis B vaccine to complete his series. MA/provider educated further.
pt spiked temp >103 on 6FEB96;vomited x 2;had sz @ home;transported by fire rescue to hosp eval dx febrile seizure;d/c good condition from ER;febrile again 8FEB96;all siblings febrile 8FEB96
Tingling; Facial numbness on left side face; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient receive BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number 588727) via an unspecified route of administration on 25Mar2021 at 08:00 (at the age of 48-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Prior to the vaccine the patient was not diagnosed with COVID-19. Concomitant medications include fexofenadine (reported as "generic ALLEGRA") from an unknown date for an unknown indication. The patient did not have any allergies to medications, food, or other products. In the afternoon on the day of vaccine on 25Mar2021 at 14:30, the patient experienced facial numbness on left side face. She felt it more in cheek. As of 28Mar2021 the patient improved by still had numbness and tingling. The event was reported as non-serious. The patient was not hospitalized for the event. It was unknown if the patient received any treatment for the event. The outcome of facial numbness on left side face and tingling was not recovered. It was also reported that since the vaccination the patient had not been tested for COVID-19.   No follow-up attempts are needed. No further information is expected.
Day after vaccine: vomiting once during the morning and three times in the late evening. Two days after vaccine: loss of appetite, paleness, late night vomiting.
patient is pregnant; tested positive for Covid after getting vaccine; tested positive for Covid after getting vaccine; This is a spontaneous report from a contactable consumer. This consumer reported for a female patient (friend). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for Covid-19 immunisation. The patient medical history and patient's concomitant medications were not reported. The patient was tested positive for Covid on unknown date in Jul2021 after receiving the Pfizer Covid 19 vaccine. Patient was pregnant. The patient underwent lab tests and procedures which included sars-cov-2 test results positive on Jul2021. Query was sent to the reporter to ask whether the patient was pregnant before Pfizer COVID Vaccine to which a response was received to clarify that the patient was pregnant, but it was not clarified whether or not the patient received the vaccine while she was pregnant or prior to her pregnancy. Investigation Assessment reported as Yes. There was a Product Complaint. Description of complaint: Caller reporting an adverse event and mentions her friend who tested positive for Covid after receiving the Pfizer Covid 19 vaccine. LOT; NDC; Expiry Date: Not provided. Caller declines to complete report. The outcome for the events was unknown.   Information about lot and batch number was requested.
Bad headache that lasted 3 days (this made my whole head sore to the touch just like my migraines do), Fever, chills(with the shakes), severe fatigue, extremely sore arm (as if it had been slammed in a car door or the feeling of being stung by a hornet) that was difficult to lift or put any pressure on it by lying on that side, muscle & joint pain, & extreme nausea that included being drenched in sweat at one point on the day after injection. With the exception of the extreme nausea, all of the symptoms lasted 3 days.
both legs swollen-lt seem to have small hematoma, rt redness over entire thigh-upper;
nausea & lightheadedness (10 minutes), diarrhea (one instance), fatigue (2 days), headache (1,5 days),  sore injection site (1 day)
11-05-05: mild warm slight raised area, C/O soreness at site and redness (left thigh). 11-06-05 worsened to more C/O soreness at site. Activities (physical ) continued. 11-07-05 (Mon) better less sore. 11/08/05 (Tue) pink area noted left thigh 19"x21" and MD referred to ED. 11/08/05; ED visit: Dx Cellulitis, Tx; Keflex times 10 days.  Improving as of 11-09-05
Narrative: 80 yo male with hx of diverticulosis, T2DM, esophageal stricture, HTN, BPH, GERD, hx of afib, coronary arteriosclerosis presented to the ED for chest pain on 3/19/2021, about 4 weeks after his last covid-19 vaccine. This event was reported since the event occurs within 42 days of the last dose of covid-19 vaccine. Per records, chest pain started after dinner, around his chest and radiated to his R arm. Pt was given aspirin 324mg PO enroute to the emergency. Pt denied any discomfort upon arrival to the ED. Hospital records stated no prior dx of CAD. However facility records show hx of coronary arteriosclerosis. EKG showed RBBB, no ST elevation or depression. Pt was admitted for monitoring and was discharged the next day (3/20/2021). On 4/9/2021, pt was scheduled for cath and was found to have 75% blockage to the LAD, pt was later scheduled for a DES.
Patient received first dose of vaccine 8/28/21 when she was 34 weeks pregnant. Tested + for covid 3 weeks later at 37 weeks gestation. Having cough, SOB, tachycardia, fever/chills.
Given 10 mcg dose of Moderna Bivalent instead of recommended 25mcg
pt recv vax 27JAN97 & on 3JUN97 pt devel a mild case of chickenpox;
Slight rash and itching at and below injection site;  injection site pain, redness and slight swelling; tiredness; headache; muscle and joint pain in injection arm; slight nausea; feeling unwell  Symptoms began about 6-7 hours after injection, progressively became worse over the first 24-48 hours , but were mostly gone by 60 hours after the injection.
Felt fatigue, chills and  had a cough.   Lasted from Friday night and all day Saturday.  Chills are gone but still feel fatigue and still have a cough.
This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient 4 days after the expiry) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 20-Apr-2022, its used by date was 20-May-2022 but was administered on 24-May -2022.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 033K212A, 017E21A, 010A21A and 042L20A) for COVID-19 immunisation. No Medical History information was reported. On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 02-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 24-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient 4 days after the expiry.). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was refrigerated on 20-Apr-2022, its used by date was 20-May-2022 but was administered on 24-May-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine was administered to the patient 4 days after the expiry) and PRODUCT STORAGE ERROR (The vaccine was refrigerated on 20-Apr-2022, its used by date was 20-May-2022 but was administered on 24-May -2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The vaccine was refrigerated on 20-Apr-2022, its used by date was 20-May-2022 but was administered on 24-May-2022. Vaccine was administered to the patient 4 days after the expiry. Concomitant drugs were not reported. Treatment details were not given. Vial did not undergo any temperature excursion. This case was linked to MOD-2022-575471 (Patient Link).
Patient is an 84 years old white male who has past medical history significant for history of end-stage renal disease.  Patient also has history of chronic atrial fibrillation and also has history of chronic diastolic heart failure.  Patient is also morbidly obese and has been compliant with dialysis and now comes into the hospital for an episode of shortness of breath.  Claims that he was in progressive worsening of shortness of breath over the last few days.  He has also been feeling very weak and tired and not able to do his activities usually.  He was noted to be somewhat hypoxic in emergency room for the same reasons.  He was evaluated ED where he was noted to have bilateral infiltrates suggestive of pneumonia it is COVID test came back positive and was recommended admission.  He denies any chest pain.  He does admit to having and dyspnea on exertion and even hypoxia and generalized weakness and feeling of tiredness.  He denies any relieving or aggravating factors and no hemoptysis or sputum production.  He denies any loss of sense of smell or taste or any fevers or shaking chills.   Worth mentioning is that he is immunized with COVID-19 vaccine with last dose in March with Pfizer vaccine.  He however has not received booster.
Fever, chills, fatigue, joint pain, headache all within 24 hours. After 24 hours dizziness redness appeared at injection sight, chest pain.
Patient passed with final vaccination, I observed the patient's eyes roll back into head. Arms/hands clenched to chest with tremors all over body.