chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Missed second vaccination dose.; A spontaneous report was received from a reporter a health care professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and missed second vaccination dose.  The patient's medication history was not provided. Concomitant medication list not provided.  On 14 Jan2021, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch not available) intramuscularly for prophylaxis  of COVID-19 infection.  The patient was due for a second vaccine on 11 Feb 2021, but was denied an appointment by the clinic nurse. Treatment information were not provided.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of the event, missed dose, was considered recovered/resolved on a unknown date.; Reporter's Comments: This report refers to a case of Product dose omission issue for mRNA-1273, lot # unknown, with no associated AEs.
Narrative:  PT WAS VACCINATED IN A TIMELY MANNER 2/11 AND  3/11 WITH MODERNA MRNA VACCINE OUTSIDE OF FACILITY. PT WAS  ADMITTED 10-9 AND HAD POSITIVE TEST AT THAT TIME. PT HAD  A LENGTHY, BUT UNEVENTFUL HOSPITAL STAY DUE TO COVID  PNEUMONIA RESULTING IN EXTREME WEAKNESS. HE REMAINED ON  RA ENTIRE STAY. HE WAS TREATED WITH REMDESIVIR, RECOVERED,  AND WAS DISCHARGED TO FACILITY FOR REHABILITATION.
Initial unsolicited misuse report received from a physician on 14 October 2015. This case involves a 67-year-old female patient who was vaccinated with an intramuscular dose of FLUZONE QIV (batch number UI443AA, expiry date 30 Jun 2016) in left deltoid on 3 September 2015. The patient's medical history includes Renal Cell Carcinoma and also had lung nodules. Apart from this pre-existing physician diagnosed allergies, birth defects, medical conditions, illness at time of vaccination and concomitant medications were not reported. On an unspecified date, 2 weeks after the vaccination the patient experienced Transverse Myelitis. It was reported that the patient was hospitalized and was on ventilator and due to patient's condition of Renal Cell Carcinoma and lung nodules, biopsy was not performed for lung nodules. The patient required hospitalization. Laboratory investigations and corrective treatments were not reported. The final outcome was reported as not recovered. Documents held by sender: none. Sender's Comments: Transverse myelitis is listed with INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. Time to onset is compatible with of a role of the vaccine. However results etiological investigation such as infectious work-up, search for autoimmune disease, and damage to blood flow, were not provided and are needed to further assess this case. Based on the available information, a role of the vaccine cannot be established.
Fever; I feel like spaced out; "brain fog"; Breathing is more labored; This is a spontaneous report from a contactable consumer (patient). A 67-years-old-female patient received BNT162B2 (Pfizer-BioNTech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot number was not reported) first dose via unspecified route of administration on 23Apr2021 as single dose for COVID-19 immunization. the patient medical history including End stage COPD. The patient concomitant medications were not reported. Patient stated, that she had end stage COPD. she received her Pfizer shot yesterday first dose. she know had fever was normal. she feel like spaced out; "brain fog". Patient breathing was more labored. she supposed to feel this way. Her son (age: 34 now but when he wasn't walking yet) received the DPT shot and reacted and almost died from it. He was laying there blue." As the Prescribing Information does not include all adverse reactions that have been reported or that may occur, please consult with your doctor/healthcare provider about what you have experienced/are experiencing. The outcome of the events was unknown.  e-transmitting for caller and son (non Pfizer AE). Caller did not want to be transferred to safety at the time of the call (7 callers ahead).  can contact caller if needed.  Response: Spoke from EUA PI (LAB-1457-7.0 Revised: 06Apr2021) under section 6 OVERALL SAFETY SUMMARY   Emailed "how long side effects last" as requested  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
numbness and tingling in both hands and fingers; numbness and tingling in both hands and fingers; Tiredness; Aches; This is a spontaneous report from a contactable nurse, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8729) via an unspecified route of administration in the left arm on 05Apr2021 at 14:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included undifferentiated connective tissue disease, rosacea, thyroid cancer and status post (S/P) thyroidectomy. The patient had no allergies to medications, food, or other products. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), hydroxychloroquine sulfate (PLAQUENIL), doxycycline (MANUFACTURER UNKNOWN), colecalciferol (D3 VITAMIIN) and meloxicam (MANUFACTURER UNKNOWN). 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 05Apr2021 at 16:00, an hour or so after the vaccine, the patient had numbness and tingling in both hands and fingers. The events had persisted with slight improvement. On the same day and time, the patient also had the expected tiredness and aches. 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 numbness and tingling in both hands and fingers were resolving and the events of tiredness and aches were not resolved at the time of report.   No follow-up attempts are needed. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: event description of 'numbness in both hands and fingers' updated as numbness and tingling in both hands and fingers'.
half of her face went numbed; face swollen; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (half of her face went numbed) and SWELLING FACE (face swollen) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 034C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jun-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 25-Jun-2021, the patient experienced HYPOAESTHESIA (half of her face went numbed). 25-Jun-2021, the patient experienced SWELLING FACE (face swollen). At the time of the report, HYPOAESTHESIA (half of her face went numbed) and SWELLING FACE (face swollen) outcome was unknown.            No concomitant medication was reported No treatment drug was reported
Pt was given incorrect dose; 1.0 mL instead of 0.5 mL of vaccine.
died in her sleep; Initial information received on 13-Feb-2022 with live follow up 13-Feb-2022 (processed together) regarding an unsolicited valid Social Media serious case received from a consumer/non-hcp.  This case involves a 40 years old female patient who reported died in her sleep while receiving vaccine Influenza Vaccine.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a  dose of suspect Influenza Vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site for immunization.  On an unknown date the patient developed a serious events died in her sleep (death) ( latency same day) following the administration of Influenza Vaccine.   It was reported that she "took her first shot and was in good health. She died in her sleep that night."  Action taken :Not applicable.  Corrective treatment : No corrective treatment reported for the event.  Event outcome : At time of reporting, the outcome was Fatal for the event died in her sleep.  Seriousness criteria : This event(death) was assessed as medically significant and was leading to death (fatal).; Sender's Comments: Sanofi company comment dated 18-Feb-2022: This case involves a 40 years old female patient who reported died in her sleep after receiving vaccine Influenza Vaccine. The time to onset was compatible. However, further information regarding the patient's event details, concomitant medications and tolerance, allergic history, autopsy reports, laboratory investigations for the reported event are needed to fully assess this case. Based upon the reported information, the role of the individual suspect vaccine cannot be assessed.; Reported Cause(s) of Death: died in her sleep
Hard nodule and growing redness at injection site that started roughly 6 days after vaccination and is progressively getting larger up to time of report
This is a spontaneous report from a contactable pharmacist through a Pfizer sales representative. A female patient (Age: 66; unit was not reported) received PREVNAR 13 (Lot number and expiration date were not reported), with route of administration unspecified on 06Nov2018 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On 06Nov2018, six hours after receiving pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein), the patient had fever and chills. The patient had received BENARDYL as treatment for the fever. The outcome of the events was recovering for fever; and was unknown for chills.
Freezing and chills, Fever of 99.2, then 100.2 Mild headache and dizziness
administered a pt an expired dose of Havrix; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 19-year-old male patient who received HAV (Havrix) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 30th June 2022, the patient received Havrix (intramuscular) 1 ml and Havrix Pre-Filled Syringe Device. On 30th June 2022, unknown after receiving Havrix and Havrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 30-Jun-2022 Reporter's Comments: The reporter stated that the patient was administered an expired dose of Havrix (expiration date 17th June 2022) intramuscularly into his left arm on the day of reporting. The reporter consented to follow up with himself/herself and with HCP. Additional Supportive Information: The patient was administered an expired dose of Havrix, which led to expired vaccine used.
Pt received influenza vaccine on Dec 9th 2005 @ 0820. She returned to work where she begin to feel itchy and feel as though she had something caught in her throat. She returned to the clinic around 1043. She was administered O2 6 liters via nasal cannula. Her vital signs were obtained. At 1050 she was given Benadryl 25mg IM and 0.3 of epinephrine. At 1100 doctor ordered 40 mg of Solumedrol IM be given. At 1103 doctor ordered 0.3ml epinephrine IM be given. Pt was transferred to hospital.
Fever ranging from 101 to 102.5 for 24 hours, chills, body aches for 48 hours,
Got vaccination on Monday evening stomach pain, Tuesday calls from school with headache, dizziness, stomach pains, weak. Returned to school on Wednsday and felt light headache sick to stomach and dizzy and swelling then came home that Wednsday night a rash had developed and so he went to physician and she ran some test on him like strep. I told her he hasn't been sick he's been perfectly fine until this vaccine he got. Test were sent off and reported back to her on 2/3/2015 with the whole weekend of rashes and swelling all over his body. The Dr then confirmed it was the HPV vaccine and that he may have short to long term of this rash with other possible side effects!
Severe achiness; vomiting; dizziness; fever; sore arm; This is a spontaneous report from a contactable consumer, the patient. A 63-year-old unknown gender patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration in the right arm on 06Apr2021 at 17:00 (at the age of 63-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and heart condition. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient was allergic to sulfa medication. The patient did not receive any other medications within 2 weeks of vaccination. 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, the patient experienced severe achiness, vomiting for 24 hours, dizziness, fever and sore arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the event vomiting, dizziness, fever and sore arm were not recovered at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
No other AEs reported.; administration of improperly stored MMR II and VARlVAX; This spontaneous report was received from a physician who refers to a 12-month-old male patient. Information regarding the patient's drug reactions or allergies, concomitant therapies and his pertinent medical history was not provided. On 11-JUN-2021, the patient was vaccinated with improperly stored: varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml one time, lot # T025944, expiry date 30-JUL-2022, and measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 ml one time, lot # S039311, expiry date 04-DEC-2021; both for prophylaxis (formulation, concentration, dose number, route of administration for both vaccines were not reported). Digital data logger was involved. The vaccines underwent the temperature excursion in the range from 14 degrees of Fahrenheit (F) to 46 F for 2 hours and from 6 F to 14 F for 40 minutes (temperature excursion was also reported as 19.7 F "max"). There was no previous temperature excursion. No additional adverse effects were reported. No product quality complaint (PQC) was involved.
I felt pain in the arm, I could feel the shot going into my arm. Within an hour it got extremely painful, I could hardly move it, I could not raise my arm. For the next 3 days, I could not lay on my left side, I could not use my arm and was extremely painful. I also noticed my lymph nodes were all swollen and sore, the ones in my neck were the worst, I had a severe headache, I was extremely fatigued and body aches. The body aches were excruciating. I was bed ridden for 3 days . I also had nausea and completely lost my appetite. I remember being very thirsty. I had really sever fatigue, it took a week before I started feeling better. I had to take a week off of work. I'm having a really hard time with fatigue now. It seemed to cause what I would call is a huge flair up of my fibromyalgia .
A few minutes after receiving the vaccines, she began feeling dizzy and queasy.  She put her head between her knees and sipped some water and the feelings passed.  We then left the exam room to check out.  After standing at the check out desk for a few minutes, she lost consciousness.  She collapsed, hitting her head on the wall/chair behind her.  The nurses and doctor laid her down on the floor and elevated her feet.  In a minute or two, she regained consciousness.  She was wheeled back to the exam room and given some juice.  Her vital signs were good and she had suffered no injuries in the fall other than a slight lump on her head.  She was able to walk out of the office about five minutes later.
Extreme muscles pain, follow followed by redness after 2nd day. Started in pm after shot. Continued then redness on 11/11/2005 it seems to have moved down arm. Tenderness and redness slowly to improve 11/12/2005. Seemed to travel from arm from injection site.
5 days following vaccine patient developed itchy rash over L arm and back.  Presented to his primary care physician on 1/27/21.
pt recvd vax & c/o diarrhea; no N/V; advised to see MD;
Dizziness with 15 minutes and lasted 2 hours, brain fog within 1 hour( still ongoing 4 hours after) headache within 1 hour( ongoing 4 hours later), slight nausea within 1 hour and lasted about 1 hour.
mom reports pt crying for hr;reports noticed lips beginning to turn blue when friend holding pt;mom picked up & patted on back pt spit up a little saliva;reports stopped breathing few seconds;to ER dx ear infect;rt thigh red & swollen;
Diagnosed with shingles on left arm; Injection site redness; Flu-like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 65-year-old male patient who received Herpes zoster (Shingrix) (batch number D924E, expiry date 8th March 2022) for prophylaxis.   On 8th November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 9th November 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema and influenza-like symptoms. On 20th November 2019, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovering/resolving and the outcome of the injection site erythema and influenza-like symptoms were unknown.   It was unknown if the reporter considered the shingles, injection site erythema and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The reporter statesd that, the improvement of these symptoms on 12th November 2018, but did not know if these symptoms have resolved at this time.  The reporter stated that the patient was diagnosed with shingles on his left arm on 20th November 2019 at a walk-in clinic. The emergency visit was required. The healthcare professional did not consent to follow up of this case.
Experiencing intermittent burning/warm and intermittently lancinating pain starting in deltoid and traveling down to elbow and wrist, moderate intensity at times. No worsening or improvement of symptoms since injection. Exam at clinic 12/18/18. Will treat the symptom of neuropathic pain and follow up in 4 weeks.
injection site warmness; injection site rash; injection site redness; itching; another rash; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (injection site warmness), PRURITUS (itching), RASH (another rash), VACCINATION SITE RASH (injection site rash) and VACCINATION SITE ERYTHEMA (injection site redness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced PRURITUS (itching) and RASH (another rash). On an unknown date, the patient experienced VACCINATION SITE WARMTH (injection site warmness), VACCINATION SITE RASH (injection site rash) and VACCINATION SITE ERYTHEMA (injection site redness). On 16-Mar-2021, PRURITUS (itching) had resolved. At the time of the report, VACCINATION SITE WARMTH (injection site warmness), VACCINATION SITE RASH (injection site rash) and VACCINATION SITE ERYTHEMA (injection site redness) had not resolved and RASH (another rash) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medications were reported
Patient has sores and rash covering legs and left wrist, was just prescribed prednisone on 3/9, waiting to see if it helps
None reported; Patient received Moderna (Spikevax) vaccine instead of Flu (Fluzone HD)
Lightheaded and ringing in right ear.   These symptoms have not subsided since vaccination. Never had tinnitus before vaccine
Pt reported feeling itchiness of the throat post vaccination. Red rash observed on chest and anterior neck. Throat appeared red and slightly swollen, however pt reported being able to swallow. Pt was able to speak clearly with no issues. PO Benadryl was given, 50 mg. Pt reported feeling better and left with a companion.
Came to the ER on 5/22/21 with symptoms of shortness of breath and difficulty breathing. Also has non-productive cough and loss of taste/smell. Started on maximum therapies, including mechanical ventilation, but did not improved.  He was transitioned to Hospice care and expired on 6/4/2021.
Pt had t105.3 on 5JUN91; No other sxs & labs nl; Pt returned to ER 7JUN91 w/t102.5; MD said "etiology of fever was unclear"; 8JUN the T disappeared in am & in the pm a rosy pink rash started on trunk; Rash to the arms & face lasted 36hrs;
The day after administered FLUMIST, my throat was sore. For a week, my voice was hoarse and coworkers thought I was ill. I had a dry cough. On 10/23, I began experiencing pain in left arm with increased in intensity in evenings, especially while laying flat. On 10/28 I had to constantly inhale as I could not stop yawning. At 3:30, the left arm pain began to gravitate to my back and by 4:30 it had moved to my chest causing shortness of breath. I went to urgent care. I had several indicators for a heart issue and was ambulanced to another hospital where I was promptly diagnosed with Pericarditis. I spent three days and followed treatment plan by doctors with prescriptions. Once off prescriptions, I had an additional Pericarditis event in March 2015 and again recently in February 2016.
The pt received vax on 2/1/01. The following day, the pt experienced redness, swelling, warmth at the site of injection.
Right quad tender to palpation. Swollen, hurts with knee flexion.  No hip pain, no knee effusion.
This is an instance of breakthrough case of COVID-19 that resulted in death.   The individual was vaccinated with the Moderna product on 12/30/2020 and 01/27/2021.   The individual became symptomatic on 04/17/2021 and tested positive for COVID-19 on 04/17/2021.   The individual was hospitalized 05/01/2021-05/04/2021 with a chief complaint of altered mental status; they were found to be septic and have a UTI and also to have developed pneumonia.  The individual responded well to antibiotics, and was therefore discharged to the long-term care facility at which they were a resident. The individual  continued to be monitored for prolonged shortness of breath,  and ultimately passed away on 05/10/2021.   Death Certificate details are as follows:  Part I Cause of Death    A: Pneumonia    B: COPD Part II Other Significant Conditions    COVID 19, Diabetes Mellitus, Schizophrenia
tingling in arm.  Felt woozy.  VSS. Observend and symptoms resolved within 20 minutes. Released home
Tested positive for Covid 19 with rapid test after learning her husband was positive.  She had a mild fever, congestion and felt tired.
I started to have an allergic reaction to my face after my vaccine. I noticed it at night that my face was getting swollen. I went to an unspecified hospital where they performed lab work, administered steroid injection and also gave me Benadryl. My symptoms started to resolve or so i thought but by  the next morning when I woke up, my face was more swollen and I again went to the unspecified hospital where lab work was performed and my symptoms lasted for one week.