chrisvoncsefalvay/vaers-outcomes huggingface dataset:
pt  admitted to hosp with c/o increasing SOB, malaise, N/V, O2 sats in 30s; placed on 60 L high flow NC; O2 sats in 70s, pt was intubated; diagnosed positive for COVID 19 and UTI; pt eventually extubated and placed on 35 L high flow NC with O2 sats @ 97%; began to wean off of O2 but later condition worsened and required intubation; pt's condition worsened and family wished to withdraw care; pt died in the hosp; respiratory failure due to COVID pneumonia as well as PE related to CHF and end-stage renal disease
Pt received ZOSTAVAX on 2/13/08 and had reported having shingles. Anti-viral and pain meds were given for ADR
Patient reports cellulitis in arm of injections. She reported to the pharmacy, exact details unknown.
Arm at site of injection is sore when raising arm in any direction. Also sore to the touch. This is more so than I remember my last flu vaccine being in 2008. This began about an hour after the shot. 9/6/2017 around 10am I began experiencing flu like symptoms - heavy head, achy body especially my back. I didn't have these symptoms during the last vaccine in 2008.
11 years ago, I had my first episode of Nonarteritic Anterior Ischemic Optic Neuropathy in the right eye. Then 5 years later followed up with another event in the left eye. After those two events, I've been treated with the Pentoxifylline, AREDS and ginkgo biloba. There have been improvements in both eyes to the point where I could drive and read newspapers again. 7 days after the vaccine, I began to lose vision in my right eye, and my left eye began to develop light sensitivity (photophobia). This continued on for days. After the 2nd vaccine, it got worse to the extent where I couldn't drive or read newspapers again. I can only read on a device with really big fonts with white printing on black background. I still have sensitivity to light (photophobia). I went to see my neural ophthalmologist, the condition in my eye is a vascular condition. Most of the reactions we've read into noted vascular reactions. My doctor noted that I should never take the booster because of the risk of losing my vision entirely. The only nexus we have is that it occurred 7 days after the vaccine.
arm is still reddish and warm; arm is still reddish and warm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (arm is still reddish and warm) and VACCINATION SITE WARMTH (arm is still reddish and warm) in an 84-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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form.   On 13-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (arm is still reddish and warm) and VACCINATION SITE WARMTH (arm is still reddish and warm).   At the time of the report, VACCINATION SITE ERYTHEMA (arm is still reddish and warm) and VACCINATION SITE WARMTH (arm is still reddish and warm) had not resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   Concomitant product use was not provided by the reporter. No treatment information was provided.
Patient reported rash developing on face within 24 hours of vaccination. No lip/tongue edema or other sign of anaphylaxis. Patient given oral antihistamine, symptoms resolved. Patient was monitored for anaphylaxis and released once no signs and symptoms of anaphylaxis were noted.
Patient had full syncope episode approximately 15 minutes after receiving the vaccine.  Patient was able to arouse quickly.  Vital Signs:  1320: BP-124/73  P-74 R-16  Pox-95% 1328: BP-114/77  P-84  R-24  Pox-97% No trauma sustained in fall.  Patient alert and orientedx3.  Patient remains very pale and weak.  Transported to Emergency Room via ambulance for further assessment.
No Adverse Event; Caller reported AE on behalf of an infant patient who was administered an expired dose of MMR-II (no prior TEs). No symptoms reported. Consent to contact HCP was denied. No additional AE/PQC.; This spontaneous report was received from a medical assistant refers to a infant patient of unknown gender.   The patient's medical history, concurrent conditions were not reported. The patient's concomitant therapies included STERILE DILUENT.  On 31-AUG-2023, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II) lot #U022316, expiration date: 15-JUL-2023, 0.5 milliliter (route of administration and anatomical location were not reported) for prophylaxis (expired product administered).
This spontaneous report as received from a doctor of pharmacy refers to a patient who was vaccinated with an improperly storage dose of ZOSTAVAX (lot # 672609/1733AA, expiration date 04-FEB-2013, dose not reported) on 08-AUG-2012. No other co-suspects were reported. No concomitant medications were reported. The doctor of pharmacy reported that one of the facilities that  he was in charge of was recording the temperature of the storage unit of ZOSTAVAX as -5F. He reports that they recently discovered that the actual temperature of the storage unit was -5C. He did not know if the patient had experienced any adverse effects. This is one of several reports received from the same source. This report is cross referenced with the following MARRS #: 1209USA002918, 1210USA006055, 1210USA006056, 1210USA006057, 1210USA006058, 1210USA006059, 1210USA006060, 1210USA006061, 1210USA006062, 1210USA006063, 1210USA006064, 1210USA006065, 1210USA006066, 1210USA006067, 1210USA006068, 1210USA006070, 1210USA006071, 1210USA006072, 1210USA006073, 1210USA006074. Additional information is not expected.
Pt. developed reactive supraclavicular lymphadenopathy on 3/23/2021 following her first COVID 19 Pfizer vaccination on 3/21/2021 in the ipsilateral arm. Details: Sunday 3/21/21 she received her first dose of the Pfizer COVID 19 vaccine to her left deltoid and the following day on Monday felt tired and a sore left deltoid. On Tuesday her soreness in her left deltoid improved but she still felt exhausted and before going to bed noted a tender bump just above her left clavicle which was tender to touch. Pt. States that it feels like a "jelly bean" size and is mobile, tender and soft to touch. Pt. States that it is much smaller on 3/25/21 than when she first noted it on 3/23/21 and appears to be improving but got concerned. Pt. States that the deltoid soreness resolved but the lump above her left clavicle persisted but she also had a headache all day and still felt tired but also nauseated but denies any vomiting, abdominal pain, changes in bowels, fevers or chills, rashes. Pt. states that3/25/21 she is feeling much better and has more energy and her headache and nausea resolved and that the lump above her left clavicle is still there but smaller in size. Pt. with no hx of lymphadenopathy after any other vaccines in the past. No hx of severe or unusual adverse reactions following immunization in past. Denies any breast or armpit complaints, fever, chills, wt loss, left arm pain or arm swelling at or around the injection site, rashes, sore throat, nasal or sinus symptoms, cough, difficulty swallowing or breathing. Of note pt. states she was ill with COVID 19 like s/s back in April 2020 but at that time testing was not available unless your were hospitalized and her s/s were mild and she self treated at home with supportive care. Pt. States that she got an antibody test 3 months later and had + COVID 19 antibodies and was recently retested for antibodies on 2/27/2021 and they were still positive.
Burning at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Burning at injection site) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis.    No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Citrate free. On an unknown date, the patient experienced VACCINATION SITE PAIN (Burning at injection site). At the time of the report, VACCINATION SITE PAIN (Burning at injection site) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in a COVID-19 vaccine trial. No concomitant medications were reported. No treatment medications were reported. This case was identified as part of a retrospective clean-up activity where certain emails received in the Moderna mailbox were missed to be booked-in.
hair loss; This case was reported by a consumer via call center representative and described the occurrence of hair loss in a 77-year-old female patient who received Herpes zoster (Shingrix) (batch number P2275, expiry date 25th September 2021) for prophylaxis.   Previously administered products included blood pressure medications. Concurrent medical conditions included thyroid disorder.   On 28th June 2019, the patient received the 1st dose of Shingrix (intramuscular). In June 2019, less than a week after receiving Shingrix, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was recovered/resolved.   It was unknown if the reporter considered the hair loss to be related to Shingrix.  Additional details were provided as follows: After received Shingrix the patient  experiencing significant hair loss within 1 week and after 3 months, the hair loss stopped. Tha patient had pre-existing thyroid problems, so patient had her thyroid checked and it was fine.  The patient saw a dermatologist, and there were no problems seen with her scalp.  The patient went off her blood pressure medications and there was no change. The patient had had a physical shortly before getting the vaccine and everything was fine then.  The follow up consent was granted.
This spontaneous report was received from a healthcare worker regarding an unspecified 6 patients of unknown age and gender. This report pertains to 2 patients who on 21-NOV-2013 was vaccinated with a dose of M-M-R II, (lot # J003002, expiry date 14-MAR-2015) (dosage regimen unspecified). The healthcare worker reported that 6 clients were vaccinated with the same lot of improperly stored M-M-R II. The healthcare worker reported details of a supported temperature excursion for M-M-R II that were exposed to temperatures of 47Fahrenheit (F) for 1 hour 48 minutes (min), 48.5F for 1 hour 13 min, and 48.5F 1 hour 13 min (also reported as the vaccine was not stored improperly, the products would not be adversely affected by this specific temperature excursion). No adverse effect reported. No further information was available. This case is linked to 1312USA005771, 1312USA010205, 1312USA010206, 1312USA010207 (Same reporter link). Additional information has been requested.
knot in the arm of the injection/knot is hard, hot to the touch and painful; knot in the arm of the injection/knot is hard, hot to the touch and painful; knot in the arm of the injection/knot is hard, hot to the touch and painful; knot in the arm of the injection/knot is hard, hot to the touch and painful; Right arm pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (knot in the arm of the injection/knot is hard, hot to the touch and painful), VACCINATION SITE MASS (knot in the arm of the injection/knot is hard, hot to the touch and painful), VACCINATION SITE INDURATION (knot in the arm of the injection/knot is hard, hot to the touch and painful), VACCINATION SITE PAIN (knot in the arm of the injection/knot is hard, hot to the touch and painful) and PAIN (Right arm pain) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced PAIN (Right arm pain). On 06-Mar-2021, the patient experienced VACCINATION SITE WARMTH (knot in the arm of the injection/knot is hard, hot to the touch and painful), VACCINATION SITE MASS (knot in the arm of the injection/knot is hard, hot to the touch and painful), VACCINATION SITE INDURATION (knot in the arm of the injection/knot is hard, hot to the touch and painful) and VACCINATION SITE PAIN (knot in the arm of the injection/knot is hard, hot to the touch and painful). On 08-Feb-2021, PAIN (Right arm pain) had resolved. At the time of the report, VACCINATION SITE WARMTH (knot in the arm of the injection/knot is hard, hot to the touch and painful), VACCINATION SITE MASS (knot in the arm of the injection/knot is hard, hot to the touch and painful), VACCINATION SITE INDURATION (knot in the arm of the injection/knot is hard, hot to the touch and painful) and VACCINATION SITE PAIN (knot in the arm of the injection/knot is hard, hot to the touch and painful) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient took one medical marijuana gummy.   Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Significant FU=event added
190 patients (9 different lot numbers) received a vaccine past the beyond use by date; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond use by date) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond use by date).    This case was created for 125th of 190 patients involved. Concomitant medication was not provided. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:CASE
Since the receiving the COVID-19 vaccination. My menstrual cycle has been shorter by greater than one week, and with increased bleeding that has lasted longer by 1-2 days.
Within a day, Patient developed flu-like symptoms which grew more severe between the first dose of vaccine and the second dose six weeks later. As her daughter, I asked if it was advisable to administer the second dose while she was sick with severe congestion, constant coughing and restricted breathing (low O2 levels) and Doctor advised the staff at Nursing home to administer the second dose.  After the second dose, her symptoms grew more severe and she became weak. Dr. said she had life-threatening anemia, which she did not have before the first vaccination, and needed a blood transfusion. A week later, she was admitted to the Hospital Emergency Department where she was given a blood transfusion. Her flu-like symptoms did not improve. Dr.  prescribed an antibiotic Z-Pac (3 day course of treatment) which began to improve her symptoms after the second dose on 3-20-2021. However, she was too ill at that point and died on 03-21-2021. It took three days for Dr. to decide what to declare as her cause of death on the death certificate and he finally decided on Cardiac Arrest.  Despite the patient's age, she was healthy and not taking any medications at the time she received the Pfizer COVID-19 vaccine. Her health deteriorated rapidly after the first vaccine and she was not able to overcome the severe anemia that resulted after the second vaccine.
pt recv vax 25OCT95 & 8AUG96 pt devel a break through case of chicken pox;pt devel 12-15 lesions on buttocks, high temp, runny nose & exp congestion;recovered by 25Aug96;
pt received covid vaccine and then could not move her arm on the side vaccine was given. the following day pt had more movement in arm but still had tingling sensation in arm and body
Information has been received from a nurse referring to a 25 years old female patient. In 2009 (reported as when she was 18 years old; she's now 25 years old) the patient received the first dose of GARDASIL (dose, lot# and route were not reported) immunization series. On 14-MAR-2016 the patient was vaccinated with the second dose of GARDASIL (dose and route were not reported, lot# L038135, expiration 27-MAY-2017) (inappropriate schedule of vaccine administered). No adverse effects were reported. Additional information has been requested.
Day of vaccine, runny nose worsened, congestion, poor sleep, by 3-4 days past vaccine, runny nose was a sinus infection; 4 days past vaccine, child developed a fever of 101. Fever lasted approximately 48 hours and peaked at 105 in spite of treatment with ibuprofen and acetaminophen at direction of care provider. During days 5-6 following vaccination, when fever was aggressive, child experienced staring and jerking (dozens of myoclonic-like jerks) while waking and sleeping. These were not febrile seizures; each jerk lasted <1-2 seconds. On day 6, child was seen by pediatrician who noticed no physical signs of infection, nor did infection or inflammation present in bloodwork. Fever and jerking subsided by day 7 after vaccination when rash started to appear. Rash covering trunk, neck, upper arms and legs lasted two days (day 7-9). Child remained extremely fatigued from day 5-day day 9.
No additional adverse effects reported; that patient received improperly stored dose; This spontaneous report was received from a physician, referring to a patient of unknown age and gender.   No information regarding the patient's pertinent medical history, current conditions, drug reactions or allergies and concomitant therapies was provided.  On 17-MAR-2020 the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) (dose, strength, route of administration, vaccination scheme and  anatomical site of vaccination, were not reported); lot number S025609, expiration date 18-AGU-2020, as prophylaxis.  Concomitant therapies included sterile diluent (MERCK STERILE DILUENT).  The administered dose of the vaccine experienced a temperature excursion -5.48 degrees Celsius for 7 hours, as recorded by a data logger. There was no adverse effect reported.
Very dizzy-off-balance, very itchy,sleepnesses.  Symptoms started on Saturday morning 10/13 and continued until Monday 10/15.
Left distal artery thrombus 2 days after receiving covid vaccination in left arm; This is a spontaneous report from a contactable physician. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), intramuscularly, administered in the left arm on 23Feb2021 (batch/lot number and expiration date were unknown) as an unknown dose number, single for COVID-19 immunization. Relevant medical history included chronic kidney disease (CKD), vitamin (vit) b12 deficiency, vit d deficiency, and hypertension (htn); all from an unknown date and unknown if ongoing. The patient received other unspecified medications for hormone replacement therapy within 2 weeks of vaccination. The patient previously took tramadol and gentamicin, from which the patient experienced known allergies. The facility where the most recent COVID-19 vaccine was administered was unknown. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 25Feb2021, the patient experienced left distal artery thrombus 2 days after receiving COVID vaccination in left arm. The adverse event (AE) resulted in a doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care, as well as hospitalization for 6 days. Therapeutic measures were taken as a result of left distal artery thrombus 2 days after receiving COVID vaccination in left arm, which included embolectomy and anticoagulation. The patient recovered from the event on an unspecified date.  Information on the batch/lot number has been requested.; Sender's Comments: Based on temporal association, the causal relationship between BNT162B2 and the event peripheral artery thrombosis cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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.
Noticed redness and tenderness on 4 gums in mouth soon after shot, visited dentist who recommended salt water rinses, have been doing that for 5 days, somewhat better but not gone, dentist mentioned that he had seen a photo of something similar in the mouths of two men who tested positive for Covid.
This spontaneous report was received on 17-JUL-2017 from a registered nurse and refers to unspecified patients of unknown age and gender. No information about the patients' medical history, concurrent conditions, drug reactions or allergies and concomitant therapies was provided. The registered nurse reported that unspecified patients were administered doses of improperly stored PROQUAD, VARIVAX, or ZOSTAVAX on unspecified dates for prophylaxis. Sterile diluent (unknown Lot numbers and expiration dates) used for reconstitution were properly stored. The following are the names of the vaccines involved with the reported Lot numbers and expiration dates (dose, site of administration and route of administration were not reported): PROQUAD [Lot # M021731, exp date 29-OCT-2017 (The date of 26-OCT-2017 automatically showed in the product screen); Lot # M044022, exp date 01-MAY-2018; Lot # M031566, exp date 24-DEC-2017; Lot # M042500, exp date 17-APR-2018] and VARIVAX [M038857, exp date 14-SEP-2018; M037642, exp date 01-SEP-2018; Lot number N001527 (as reported), exp date 13-JAN-2019; Lot # N014368 (as reported), exp date 09-MAY-2019] and ZOSTAVAX [Lot # M034765, exp date 26-OCT-2017.] The temperature excursion was reported to be 15 degrees Fahrenheit to 46 degrees Fahrenheit (19.6F). The time frame was reported as 13 hours. There was no previous temperature excursions. The call was because of a "data logger." No adverse effects reported. No further information provided. Additional information has been requested.