chrisvoncsefalvay/vaers-outcomes huggingface dataset:
66 yo vaccinated man with medical history notable for stage IV mantle cell lymphoma (in remission), melanoma, CKD, COVID-19, and BPH who was admitted on 12/10/21 for syncope and hypoxemic respiratory failure c/f infectious vs infl process.   Patient initially underwent induction therapy with rituximab, bendamustine, Ara-C in 8/2021 for bone marrow transplant (in anticipation of relapse), but tested positive for COVID in 8/2021. Received Regeneron at the time. Admitted 11/29-12/3 for community-acquired pneumonia and COVID pneumonia, treated with antibiotics, steroids, remdesivir. Patient present cough, fever 103.3, hypoxia. Patient initial CTA showed RLL. Started on Vanc/cefepime/doxy. Extensive pulm workup neg including beta-glucan, mycoplasma, chlamydia, crypto, cocci. Patient was retreated with remdesivir on 12/11. Second course of regeneron on 12/13. Patient weaned to 4L NC at one point, but started to have progressive worsening once the Vanc/cefepime were stopped. Patient placed back on HFNC on 12/23 and was restarted on vanc/mero/vori (+fungi in lungs/urine). Admitted to ICU on 12/27 for iNO. CXR showed worsening pneumonia R>L. CTPA on 12/27 neg for PE but with worsening consolidations and GGOs as well as bronchiectasis and small b/l pleural effusions seen. Also shown to have mediastinal adenopathy. Started on Solumedrol and Bactrim for PJP PPx. Bactrim was later transitioned to atovaquone due to thrombocytopenia and intrinsic AKI after G6PD was ruled out. Patient was between CPAP and HFNC.  Immunology consulted as Ig panel low and started on IVIG (12/28-1/1). S/p vanc course (12/22-29), meropenem (12/22-29), and voriconazole (12/23-29). ANCA, ANA, nuclear Ab panel, RF, anti-CCP, anti-GBM neg. Confirmed to be persistently COVID+ based on mRNA strand test. Patient intubated on 12/31. He was initially sedated with propofol (but developed elevated triglycerides so this was switched to dilaudid), precedex, and fentanyl (discontinued due to facility shortage). Required phenylephrine for blood pressure support. CXR showed L pneumothorax and a pigtail tube was placed. Patient desatted to 80s% on 1/1 with worsening pneumothorax on CXR so a surgical chest tube was also placed in the left lung. Both pigtail and chest tube had air leaks. Daily CXR initially showed slight improvement of pneumothorax, but subsequent CXR showed worsening pneumothorax. Patient developed subcutaneous emphysema in his neck bilaterally on 1/5. Patient also had elevated CO2, but ventilation settings were unable to be increased significantly given pneumothorax. Discussed patient's illness with family daily and family decided to change code status to DNR with no escalation of care on 1/6. After the patient's wife and children were able to visit patient, his ventilation settings were changed to room air (FiO2 21%) and phenylephrine was stopped. Patient was pronounced death at 2132 1/8/22. Family notified. As this was covid-related, death was reported to coroner
Fever, chills, myalgias, hyperesthesia of skin, night sweats. Started about 10 hours after vaccine and lasted about 24 hours
This spontaneous report as received from a physician assistant referred to a patient of unknown age. Physician assistant mentioned that patient received the 2nd dose of GARDASIL (Lot#, dose/frequency, route were unspecified) on 12-APR-2012 and was in the office today, 13-FEB-2013 for the 3rd dose of GARDASIL (Lot#, dose/frequency, route were unspecified). The patient was not experiencing any known symptoms. The outcome and relationship were not provided. Additional information has been requested.
Information has been received from a physician who heard from two parents about a girl who on an unspecified date was vaccinated with a dose of GARDASIL. The patient experienced neurological problems after receiving GARDASIL. At the time of the report the patient's outcome was unknown. It was unspecified if the patient sought medical attention. Follow up information was received from an office manager. He said that he did not remember this event being discussed and he said he "would check it out". All telephone attempts to obtain follow up information have been unsuccessful. No further information is available.
Starting 4/13/19 AM patient started to feel extremely exhausted and primarily laid in bed and slept most of the next few days.  She didn't feel sick (flu symptoms) but just very very exhausted.  She said she didn't feel like getting up to even eat.  She said she should have gone to the doctor but felt too tired to get up to go.  Her left arm also started to swell 4/13/19 AM...getting red and raised, felt very warm, and hurt very bad.  She monitored it and by Tuesday 4/16/19 the swelling had gone down and was just pink.  She is a nurse and said she watched her harm to make sure it wasn't getting too bad and if it would have gotten any worse she would have gone to the doctor.  After about a week from the vaccine, she felt back to normal.  At no time til today did she report this reaction to us as the pharmacy who gave the vaccine or to any other medical provider.
that last shot made me immediately sick but I only had my arm sore and it actually gave me lots of energy but still have the headache; I only had my arm sore; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 (Lot number: EWOISI) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "nauseous" (unspecified if ongoing); "bad headache" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Covid vaccine details: , Product: COVID 19, Brand: PRized , lot number=7534, lot unknown: False, administration date: 17Mar2021, administration time: 06:00 PM, vaccine location: Left arm, dose number: 1), administration date: 17Mar2021, when the patient was 55 years old, for COVID-19 immunisation, reaction(s): "I was nauseous", "headache", "really tired". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "that last shot made me immediately sick but I only had my arm sore and it actually gave me lots of energy but still have the headache"; LIMB DISCOMFORT (non-serious), outcome "unknown", described as "I only had my arm sore"; HEADACHE (non-serious), outcome "not recovered", described as "headache". Therapeutic measures were not taken as a result of illness, limb discomfort, headache.  Additional information: Then the second Pfizer shot in the left arm again was on for 7:21 and that last shot made me immediately sick but I only had my arm sore and it actually gave me lots of energy but still have the headache. No prior vaccination patient received. Patient was not tested post vaccination for COVID-19. Patient had no known allergies.   No follow-up attempts are possible. No further information is expected.
Pt. states that after receiving the 2nd dose of Moderna 09/13/2021, started experiencing symptoms 09/14/2021 of vertigo, muscle pains, nerve pain throughout the head, and numbness in both hands (left hand more). Blood Pressure low (96/62) and Pulse (122). Still continuing to experience symptoms.
Patient received vaccine at 11:45 am on 2/17/2021 at  Fairgrounds through Public Health. noticed tingling in the right side of his face at approximately 2:55pm. He called the office of public health to notify of tingling. Receptionist later told RN of reaction, where she then called the case and advised to take Benadryl and seek medical care if worsens or other symptoms develop. Case denied SOB. RN emailed and called writer around 4:30pm to notify to follow up for VAERs. Writer called case this morning 2/18/2021 at 10:06 am  to follow up with case. Case reports he did not have Benadryl to take but noticed an improvement in his tingling with no evidence of it as of 6:30 pm last night, 2/17/2021. In conversation, case also admitted that he had noticed a slightly red irritation of his arm surrounding his first injection site 8 days after his first injection. No irritation noted following this injection. Denied SOB, swelling, and rash.
Mother called today and stated her son developed hives all over his body this afternoon.  I instructed  her to give him Benadryl and follow up with family doctor.
COVID-19   2. Pulmonary embolism without acute cor pulmonale, unspecified chronicity, unspecified pulmonary embolism type
Injection site swelling, warmness, pain, and itching (with no rash or hives)
Arrived to receive his second COVID-19 Pfizer vaccine. Upon administering the vaccine, the syringe malfunctioned and retracted mid-injection. The patient received part of the dose and the remainder spilled out of the syringe and onto his arm. I consulted with the immunization team and was told to re-dose the patient per their previous conversations with the Pfizer rep. We re-administered the vaccine and we observed the patient for 30 minutes.
46 year male presented to vaccine clinic, scheduled for a Moderna booster. Reconciled past immunization records on multiple databases, pt had received 1st  dose (04/16/21) and 2nd dose (5/13/21) of Moderna. Dates of prior vaccinations were missed during registration and vaccination, indicating too early for 3rd dose. Pt received 0.5cc of Moderna on 10/21/21 @ 10:41, double the recommended volume of 0.25cc for booster as well as less than 6 months from his previous dose. Pt did not have any allergic reaction or adverse event during 15 min monitoring period nor upon leaving.    Moderna Lot #11F21A, exp 1/19/2021
feel unwell most of the day; extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only worked 3 hours/day; pain in injection site, spread within 6 hours to all joints; pain in injection site, spread within 6 hours to all joints; headache; severe pain all muscles; nausea; This is a spontaneous report from a contactable other health professional (patient herself). A 58-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EK5730), via an unspecified route of administration on 31Dec2020 12:30 in right arm at single dose for covid-19 immunization. Medical history included asthma, fibromyalgia, perimenopause issues. The patient was known allergies: amlodipine; yellow jackets/hornets. The patient had COVID-19 prior vaccination. No other vaccine in four weeks were taken. Concomitant medication in two weeks included fluticasone propionate, salmeterol xinafoate (ADVAIR), zolpidem tartrate (AMBIEN), estradiol, mepolizumab (NUCALA) and oxycodone. Facility type vaccine was nursing home/senior living facility. On 01Jan2021, patient experienced pain in injection site, spread within 6 hours to all joints, then within 24 hours had headache, severe pain all muscles, nausea, and extreme fatigue 3 days in bed, for days 4-15 extreme fatigue so only worked 3 hours/day.  All symptoms persist. Day 18 not in bed, but patient felt unwell most of the day on 18Jan2021.  Lots of rest was required not normal for her. Events resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included COVID-19 antibody test: positive on an unspecified date and nasal swab: negative on 15Jan2021. No treatment was received for events. Outcome of events at the reporting time were recovering.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the fatigue and other reported events due to temporal relationship.  There is limited information provided in this report.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
20 MINUTES AFTER RECEIVING VACCINE, SHE COMPLAINED THAT SHE FELT A HOT SENSATION THROUGH HER BODY RIGHT AFTER THE VACCINE THAT LEFT AS QUICK AS IT CAME. SHE COMPLAINED OF FEELING LIKE THERE WAS A "LUMP IN HER THROAT".  SHE DENIED ANY SWELLING OR DIFFICULTY  BREATHING, ONLY THAT IT FELT LIKE A LUMP IN HER THROAT.  THIS SYMPTOM GOT BETTER IN BY THE TIME SHE LEFT THE HD AT  NOON.
2nd Moderna 11:09 c/o "chest rush" & Headache Hx anxiety, depression, HTN, fibromyalgia Meds:Norvase, celebrex, Citalopram,Gabapentin,HCTZ,Lorzapem,Cozaar,K, Prevachol,Zanaflex Assess: denies CP, nausea, vomiting, dizziness. rt deltoid benign. vital signs 11:09 BP190/72,HR 70 reg resp 14 O2 sat 97%. brought pt to recovery area to monitor. 11:13 BP 190/72, HR 69, Resp 12, O2 sat 97%. Med Eval Doctor called to see pt. Continued to monitor pt vital signs. No other complaints of other symptoms 11:25 BP 198/74 HR 80  Pt Primary was called made appt to see pt 3:30. 1 hr recovery. 12 pm bp 184/70, hr pt stated feels fine. Dr ok'd pt to leave advised if any issues arise to go to urgent care or hospital.
Sever rash that showed up on my arm, neck, and stomach. Very itchy and red. I received both rounds of the Moderna Covid 19 vaccine
Tachycardia, elevated heart rate (160) immediately after receiving 1st vaccine Narrative:
Within 20 minutes of vaccination patient advised us that she felt her heart racing, otherwise she felt fine. The first blood pressure reading at 7:41 was 148/104, by 8:02 the blood pressure was 155/90, 8:12 155/95 by 8:32 blood pressure was back up to 148/101. The entire time patient said she felt fine except for a heart pounding/palpitations. We contacted 911, by 8:50 paramedics were on scene patient's blood pressure was over 150/100- She did not want to go to the hospital and will be following up with her physician.
01/03/22 presents to medical facility for "scheduled IOL". PMHx of "Gestational diabetes" "Gestational hypertension"
This individual received her Covid-19 vaccination on 12/30/2020. She waited her 15 minutes following vaccination as recommended and was released and she was having no adverse reactions at that time. This individual called in on 12/31/2020 and reported when she was driving home she felt a tingling sensation from her nose to her chin. She felt very "weird" then her entire body got hot. She reports it lasted approximately 2 minutes, then resolved. She continued driving home and did not experience any respiratory issues or hives.
"Slight ecchymosis and swelling, non tender, full ROM w/o pain" per note.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2008, the patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided), as recommended for routine adult health maintenance for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On an unknown date in 2015, the patient was treated for a blistering vesicular outbreak that was diagnosed as severe herpes zoster or shingles. The outcome of the events is unknown. As a direct and proximate result of ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 02-Mar-2022; No adverse event; Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 02-Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 02-Mar-2022), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 02-Mar-2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 025L21B) for COVID-19 immunisation.     No Medical History information was reported.    On 02-Mar-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 02-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 02-Mar-2022). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 02-Mar-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 02-Mar-2022), PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 02-Mar-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine after 30-day Use by Date was 12-Feb-2022 and patient received Monovalent shots on 02-Mar-2022) and PRODUCT STORAGE ERROR (Vaccine was stored in the refrigerator on 13-Jan-2022, patient received Monovalent shots on 02-Mar-2022).    Concomitant product use was not provided by the reporter.  It was reported the vials were shipped on 13-Jan-2022 and thawed in a cooler while being transported. Vial size was 5.5 ml red cap. Vials did not undergo any temperature excursions.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-682174, US-MODERNATX, INC.-MOD-2022-682176 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 02-Dec-2022: Live follow up added included updated reporter and narrative information.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-682174:Monovalent (Same reporter) US-MODERNATX, INC.-MOD-2022-682176:Monovalent (Same reporter)
Felt out of breath, pulse pounding, blood pressure went to 141. Normally 110-120
I took the flu shot twice, got the flu immediately; Initial information received on 12-Dec-2022 regarding an unsolicited valid Social Media non-serious case received from a consumer/non-health care professional.  This case involves a 77 years old and unknown gender patient took the Influenza Vaccine shot twice, got the flu immediately.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.   On an unknown date, the patient received unknown dose of suspect influenza vaccine produced by unknown manufacturer (lot number, strength, frequency, formulation, expiry date: not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunisation).  On an unknown date the patient took the flu shot twice, got the flu immediately (influenza) (unknown latency) following the administration of influenza vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event.
Pt c/o nervousness/dizziness.  BP 86/40, HR 86, RR 16 -- > 105/48, 82, 16.  Orthostatics 95/69,90 -- > 95/68, 91 -- > 93/66, 84.  Pt stable and released from vaccination site.
I take warfarin and get my INR checked every 5 to 6 weeks and it?s usually around 2.0 to 2.5 for a long time it?s been under control. But ever since I?ve taken the COVID shots my INT has been crazy a week after I got the Covid shot my INR went to 4.8 which means my blood is dangerously thin. After my second Covid shot it was 4.1 again very high. I was on vacation in Hawaii when I had a very sharp cramp in my thigh having blood clots I was afraid it might be a blood clot so I went to the ER in another state, they did an ultra sound on my leg and they said I had a whole in my thigh where I was having pain and it?s filled with liquid, they suspected because my INR was 4.8 it caused the whole in my thigh. I?m just saying my INR has been under control for years and as soon as I get the Covid shot I can?t get it under control . Today I had it checked and it is 4.0 very high dangerous it could cause a bleed.. thank god I haven?t had any bleeding. I think it should be checked.
The baby had a change in behavior, crying a lot for 1 week following vaccination. A hard lump developed at injection site and still exists 2 weeks later. Fever of 102 for 2 days after shot.
Client fainted immediately after 4th of 4 vaccines administered.  Skin pale, diaphoretic with jerking activity and stiffness of upper extremities.  Regained consciousness after being laid prone within seconds.  Treatment included monitoring vital signs, positioning prone with legs elevated above heart.  Recovery at 45 minutes post administration of vaccines at which time she was sent with mother with instructions if further adverse events should occur.  B/P 90/50 at lowest to 100/60 when no further symptoms, pulse 60-64.
It felt like a cold; I had an increase in nasal congestion and gave me a sore throat. I had a low-grade fever - max it reached was at 100 F. That was three days after symptoms started. Initial treatment was Antihistamines, and I took high dose Vitamin C; and I did a nasal swab - over the counter - to reduce the duration of colds - Vigam. Five days after symptoms started, Tuesday, (20th) I went into the Urgent care and was started on Amoxicillin - 875-125 twice daily. The symptoms were resolved by 10/23. The fever was only one day around the 20th and 21st.
For 12-36 hours following injection I experienced fever, chills and severe joint and muscle pain as well as fatigue.  Joint pain in bilateral knees has persisted .  Additionally, I have had headaches facial twitching on my left face/eyelid persistently since the injection as well as oropharangeal numbness and lip swelling (bottom lip) intermittently.  I have notified my PCP of this.  I have an exceptionally heavy and longer menstrual period after both first (Same location, 8/9) and second Pfizer doses.
This spontaneous report as received from a nurse practitioner via company representative refers to a 14 year old female patient. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant and historical drugs was unknown by reporter. On an unknown dates, the patient was vaccinated with 2 doses of GARDASIL 9 (route, lot # and expiration date were not provided), according to schedule, for prophylaxis. Subsequently, on an unknown date,  the patient experienced Human Papilloma Virus (HPV) on the roof of her mouth. It was reported that, on an unknown date, the patient sought medical attention by an office visit. The reporter stated that the patient planned follow up with an unspecified ear, nose and throat doctor for treatment. It was unknown if diagnostic laboratory tests were performed. At the reporting time, the outcome of oral papilloma and the causality between the event and GARDASIL 9 were unknown.
approx 2mos p/vax pt exp breakthrough chickenpox consisting of 80-100 lesions. addl info requested