chrisvoncsefalvay/vaers-outcomes huggingface dataset:
swelling; bruising; like there is a pocket of fluid in my underarm/ armpit area; her armpit is sore; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 47 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 26Jan2022 (Batch/Lot number: unknown) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU, administration date Dec2021. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot: ER8781), administration date: 21Apr2021, when the patient was 46 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Lot: ER8730), administration date: 31Mar2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: SWELLING (non-serious) with onset 27Jan2022, outcome "not recovered", described as "swelling"; CONTUSION (non-serious) with onset 27Jan2022, outcome "not recovered", described as "bruising"; LYMPHOEDEMA (non-serious) with onset 27Jan2022, outcome "not recovered", described as "like there is a pocket of fluid in my underarm/ armpit area"; AXILLARY PAIN (non-serious) with onset 27Jan2022, outcome "not recovered", described as "her armpit is sore".   Additional information: The patient not received additional vaccine on the same date of Pfizer vaccine. The patient received flu vaccine within four weeks prior to administration. she received her PBCV booster dose on 26Jan2022. On 27Jan2022, the patient has experienced swelling, bruising and "like there was a pocket of fluid in my underarm/ armpit area. She states it was not hot, not discolored on the pocket and her armpit was sore. Also, the swelling was not changing. Caller states she was looking at the Pamphlet they gave her after her shot. Caller states she had the shot on Wednesday and her arms feel sore like they would with a Tetanus shot but she considered that to be normal. Treatment received none, going to ice later.  The lot number for bnt162b2 was not provided and will be requested during follow up.
This spontaneous report was received from a 50 year old male consumer refers to himself. The patient had high blood pressure and was allergic to penicillin. On 19-OCT-2013 the patient was vaccinated with ZOSTAVAX (lot# and expiry date not provided) 1 time vaccine. Concomitant therapies included COMPLERA, WELLBUTRIN, Basics Water Pills and lisinopril. On 26-OCT-2013, the patient had a reaction to ZOSTAVAX and described it as raised red areas which was dry (similar to warts or a callous which he stated was no shingles or a rash) on the palms of both hands and inside his fingers on both hands and on the bottoms of both his feet. He further stated that he had a follow up with his clinician. No lab diagnostic studies performed, no treatment received for the events and the patient sought medical attention. No product quality complaint involved. Additional information has been requested.
Watery diarrhea (no blood or mucus) started 6 days after first Covid vaccine. Lasted 5 days. Treated with OTC loperamide on day 2.
Red, swollen arm with rash at injection site on 3/25/2021.  Headache, low grade fever, low energy Tylenol during daytime; Benadryl at night for itching , 3/29/2021,  arm still swollen and red in one location near inside elbow.
My child was accidentally given moderna instead of Pfizer even though she is under 18. After the mistake was made she began to have nausea and vomiting, headache and lethargic. After 6 days she began to have chest pain, rapid heartbeat and the nausea continued. We have ended up in the hospital admitted because of the tachycardia.
mom reports pt to have typical localized rxn p/vax;redness, warm to touch area @ inj site which subsided in 2 days;states rasied, reddened, warm to touch & then reoccurred @ inj site 4 days later;
Chest tightness, Short of breath, vertigo, disorientation starting the day after injection and continuing even until now, over a week after.
I began experiencing cold symptoms. I had sneezing, runny nose, congestion, and a headache. Then I found that I had a cyst in my left eye. I had irritation in my eye and it was large enough to be visible. It was inside the eyeball, not on it or around it. I visited my ophthalmologist and he noted it was not something to be concerned about at this time. I am scheduled for another check up tomorrow. He said it may require laser surgery but chances are, my body may absorb the cyst. Seeing the cyst in my vision has diminished, but I'm unsure if it has disappeared.
Breakthrough case admission after 5 vaccines Moderna 1/8/21 Lot# 025J20A; Moderna 2/5/21 Lot# 012L20A;  Moderna 10/27/21 lot# 039D21A;  Moderna 5/9/22 Lot# 056M21A;  Pfizer 9/23/22 Lot# GH9703
pt recv vax 16OCT95 & approx 1 wk later pt exp dizziness, fatigue, gen weakness, nausea & h/a;several days later pt sx resolved w/o MD intervention
By 5 pm on 4/6, soreness of left arm, fatigue, minor headache and slight nausea/dizziness.  On 4/7, symptoms worsened throughout the day (headache, fatigue, nausea, dizziness) and included lack of appetite and hydration (not wanting water, etc.), overall achiness, with more extreme pain in the left arm, neck, low back and legs.  I went to bed at 4:30 in the afternoon, feeling ill.  On 4/8, I woke up feeling considerably better, however still a slight headache and achiness.  I took Tylenol on 4/7 (twice).
Stomach cramps, vomiting (coffee ground emesis), diarrhea that started on 04/06/2021 and lasted for 2 days.
12-14-10 4:20 pm patient states he felt fine - RN told him after waiting 15" that he looked "flushed", (red in the face) but he felt okay. BP 152/98 P 92 R 16 Temp 98.5. Nurse called Dr office and he was seen 4:50pm. 6:45 pm pt called by telephone states he is fine but still flushed & given BENADRYL/CLARITIN by MD if he needs it. BP at Dr's office 123/73. 12/16/10 10:30 spoke with pt this AM, states he feels fine but went back to MD yesterday for follow-up (12-15-10). States flushing is resolving and he feels fine - BP remains elevated - states Dr changed his BP meds yest. to Trandolapril 4mg & Verapamil ER 240mg continues the same. Denies taking any other supplements or vitamins. States occ. uses ADVIL but none on 12-14-10. To follow-up for hypertension with Dr in 2-3 wk per pt.
Pt has 1 1/2 hours of crying on evening of vaccination. Next day > 4 hours of inconsolable crying. Low grade fever 100.5.
Patient came in to clinic with "a reaction to the tetanus shot."  Received Td immunization at this clinic 12/04/08 and on 12/11, patient noted that site became red, swollen and hot. Writer Noted large area (approximately 5cm wide by 7cm long) of erythemic patch, slightly raised, on L deltoid. Very hot to touch with one small streak going from top of erythemic patch in cephalic direction. Erythemic patch did not blanche. No adenopathy of L axilla noted. Sent to urgent care for evaluation and further treatment not available at these clinics.
which was given halfway down the right arm, closer to elbow than the shoulder; She had a red spot where she got the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 16 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1 in right arm), administration date: 01Apr2021, for COVID-19 Immunization.  The following information was reported: PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (non-serious) with onset 22Apr2021, outcome "unknown", described as "which was given halfway down the right arm, closer to elbow than the shoulder"; RASH MACULAR (non-serious) with onset Apr2021, outcome "unknown", described as "She had a red spot where she got the shot".  Additional information: Caller stated that her daughter is 16 years old and received her second Pfizer vaccine dose on 22Apr2021, which was given halfway down the right arm, closer to elbow than the shoulder. She had a red spot where she got the shot, so knew it was the wrong area on her arm. It was not given into the muscle like it should have been given. Caller queried will this shot be effective if it was not given into the muscle and were going to take patient for an antibody test to see if she has any antibodies from the 2 vaccine doses.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Redness & swelling at injection site, very sore arm, headache and chills during the first night and following day, some slight body aches.
Information unavailable.  Medical records not received from LTC facility.  Patient tested positive for Covid-19 on 09/09/2021 and died in facility on 10/11/2021 with Covid 19 listed as cause of death on certificate.
11AM nurse notified that pt appeared pale; pt had recvd HEp B vax-placed in exam room 02 & EPI administered; mom reported that pt did not eat much in AM;
Day 1 - I developed a rash on my face and upper chest, just below the neck. Day 2 - I woke with a severely swollen left cheek and right eye. The swelling remained severe for three days, worsening on Day 2, and lessening on Day 3. Over three days, I continued to develop new rashes on various parts of my body, including both arms and legs, and along my spinal column.  The rashes remained on my face and upper chest. I remained bedridden Day 2 and 3. It is currently Day 5 - the swelling has gone down considerably, though is still present in my left cheek and right eye.  I still have multiple rashes. I feel I'm on my way toward recovery.
Immediate symptoms - I have limited recall - immediate sensation of vaccine flooding through my system.  I have no memory of driving home.  I must've gone to bed immediately - slept 24 hours.  Called P.A. who told me to go to hospital.  I didn't think I could drive there, but no friends were available, so I did - very carefully.  Emergency room did blood tests; only found potassium deficiency.  Went home and slept 10 more hours.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of GARDASIL 9 lot # M011117, expiration date 07-DEC-2017 (dose and route of administration were not reported). There were no symptoms reported. Administered dose of vaccine experienced the temperature excursion of 47.7 degrees Fahrenheit for 36 minutes. Data logger was involved. There were previous excursions of 46.7 degrees Fahrenheit for 19 minutes and of 63 degrees Fahrenheit for 5 hours and 15 minutes. Additional information has been requested.
Swollen lymph nodes, swelling, and readness, shortness of breath, fatigue, body aches, dizziness, light headedness, headache, fever, elevated white cell count.
Jan 26 develop shortness in breathe, back and chest pain with low o2 stats
We inadvertently administered the vaccine past the 30-day Use by Date. According to the manufacturer the vaccine administered on June  9, 2022 from lot number 065K21A likely did not  maintain the activity necessary to fully protect against the SARS-CoV-2 (COVID-19) virus at time of administration.
enlarged upper left atrium; little soreness where the shot was; This spontaneous case was reported by a consumer and describes the occurrence of LEFT ATRIAL ENLARGEMENT (enlarged upper left atrium) and VACCINATION SITE PAIN (little soreness where the shot was) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type 2 diabetes mellitus. Concomitant products included METFORMIN, INSULIN GLARGINE (LANTUS) and ATENOLOL for an unknown indication.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LEFT ATRIAL ENLARGEMENT (enlarged upper left atrium) and VACCINATION SITE PAIN (little soreness where the shot was). At the time of the report, LEFT ATRIAL ENLARGEMENT (enlarged upper left atrium) and VACCINATION SITE PAIN (little soreness where the shot was) outcome was unknown.            Concomitant Medications include Novalab. Treatment Medications include Blood thinner
This is a spontaneous report from a noncontactable consumer (patient). A 32-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine; batch/lot# unknown), at the age of 32, via an unspecified route of administration, on an unknown date, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. On an unknown date, patient had diarrhea. The outcome of diarrhea: unknown (at the time of this report). No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
tested+ for covid  was admitted on  10-2-22 and expired 10-9-22.    had h/o chf, afib and pancreatic cancer.  He had sob and weakness .  cxr left pleural effusion.  anemia, elevated bun and creatinine, low sodium, hypotensive.    did not want hospice and was DNR ..  final dx were hyponatremia, kidney injury, anemia, leukopenia, covid 19, pancreatic cancer, sepsis, hypotension among others.  He did have levophed and was givn remd and dexa and wanted to be given comfort care measures.
Pt called the pharmacy 2 days after receiving a flu shot, saying she still had shoulder pain. She said she suspected it was nerve damage because the injection was too close to the shoulder.
Hospitalized 12/2/2021; COVID-19 positive 12/2/2021; fully vaccinated  BRIEF OVERVIEW: Admission Date: 12/2/2021 Discharge Date: Dec 7, 2021 DETAILS OF HOSPITAL STAY: PRESENTING PROBLEM: Pneumonia due to COVID-19 virus [U07.1, J12.82]   HOSPITAL COURSE: A 56 y.o. male who presents 12/02/2021 with complaints of cough productive of greenish sputum, malaise and fatigue that has been going on since 11/18/2021. The symptoms were abrupt in onset and seemed to be improving up until 2 days prior when noticed said coughing) was worsening with more copious sputum. And it has awaken him from sleep, is mid-chest pain without radiation, and increasing work of breathing. He also reports chills, but denied fevers.   In the emergency department he was noted to be hypoxic to the mid 80s and briefly required BiPAP for respiratory support.  He was also noted to be tachycardic, but other vitals vitals remained relatively stable.  CT angiogram was obtained, without evidence of PE, but noted findings consistent with COVID-19 pneumonia.  He eventually did test positive for COVID-19.  Also significant presentation was elevated cardiac enzymes with anti proBNP of 1686, elevated troponins with a delta 56 which raise concern for cardiac injury.  Cardiology was consulted and recommended a repeat echo and transferred to the Hospital for further evaluation.   On EKG, ischemic changes noted, with elevated troponins.  Heparin gtt started. Dexamethasone started. Cardiology consulted. Echo with mod hypokinesis of lateral wall, apex, hypercontractile base consistent with takotsubo vs LAD stenosis, ECG concerning for Wellens syndrome. He was planned for left heart cath, however, LHC initially held for AKI, and anemia. No signs GIB while on heparin gtt. GI consulted for anemia. EGD 12/5 unremarkable. Heparin gtt resumed. AKI resolved   Status post left heart catheterization 12/6/2021 which found - mild Coronary Artery Disease. Given a unit of PRBC status post heart catheterization with robust response, and heparin gtt stopped. Echocardiogram abnormalities consistent with Nonischemic Cardiomyopathy - Takotsubo cardiomyopathy. Echocardiogram with ejection fraction 40-45%, with moderate Aortic Stenosis. Patient was discharged in stable condition, in no acute distress, O2Sat >92% on room air.
Two weeks after receiving the vaccine the patient started having grand mal seizures patient what's healthy no health problems a active marathon runner and college student now patients is unable to do anything alone I have suffered with multiple seizures since the first one happened since the first one she's had at least 6 - 8 more
I had pain in my chest on the left side. I called the EMT to take me to hospital.  I thought I was having a heart attack.  The pain got worse when I arrived at the hospital. I know they gave me a nitro-glycerin pill when I arrived.  I don't remember any other medications except for pain relievers. I was admitted and stayed overnight . The pain subsided the next day and they discharged me.
Guillain Barre; excruciating pain; This case was reported by a nurse via sales rep and described the occurrence of guillain barre syndrome in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th March 2019, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and pain. On an unknown date, the outcome of the guillain barre syndrome and pain were unknown.   It was unknown if the reporter considered the guillain barre syndrome and pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and patient experienced excruciating pain post vaccination later diagnosed with Gillian Barre. The reporter was agree to follow up from the Glaxosmithkline.
Narrative:  COVID infection following completion of COVID vaccine series: 12/30/2020 COVID vaccine dose #1 01/20/2021 COVID vaccine dose #2 07/08/2021 Pt presented to ED c/o loss of smell x 7 days and slight rhinorrhea and sneezing. Requested be tested for COVID. 07/08/2021 COVID positive per facility nasopharynx swab 07/10/2021 Pt reported still largely asymptomatic except for loss of smell. 07/12/2021 Pt reported continued loss of smell.
Body aches fever of 100.6°F and chills; Body aches fever of 100.6°F and chills; Chills; Her hand started to hurt; This spontaneous case was reported by an other and describes the occurrence of PAIN IN EXTREMITY (Her hand started to hurt), PAIN (Body aches fever of 100.6°F and chills), PYREXIA (Body aches fever of 100.6°F and chills) and CHILLS (Chills) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018b21a) for COVID-19 vaccination.     The patient's past medical history included Hypertension (Patient on hypertensive medicines.) since an unknown date and Cholesterol (Patient is taking medicines for cholesterol.) since an unknown date. Concomitant products included OMEPRAZOLE for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, the patient experienced PAIN IN EXTREMITY (Her hand started to hurt). On 24-Mar-2021, the patient experienced PAIN (Body aches fever of 100.6°F and chills), PYREXIA (Body aches fever of 100.6°F and chills) and CHILLS (Chills). At the time of the report, PAIN IN EXTREMITY (Her hand started to hurt), PAIN (Body aches fever of 100.6°F and chills), PYREXIA (Body aches fever of 100.6°F and chills) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
At the time of being inoculated, the patient felt dizzy. Upon reaching the observation area, the patient presented emesis. Vital signs were taken and she was observed for half an hour, which was consulted with Doctor.
Extreme joint pain, massive headaches, fever of 103, neck pain, back pain, knee pain, ankle pain, elbow and shoulder pain, light headed, passed out,
pt recvd vax; 4feb96 rash, lumps behind ear; joint pain on 9feb and 10feb;
A pharmacist reported that a patient received an injection of Flu Shield (2001-2002 Formula). Subsequently, the patient developed an injection site reaction characterized by redness and nodules. No further information was available at the date of the report. Manufacturer's Comment: The reporter indicated that 5 patients experienced this event; however, they are not presently identifiable. Additional reports will be generated when identifying information is provided.
Swelling at Right cubical with redness, rash and itching. No difficulty breathing. Advised to go to nearest ER for evaluation.
On 10/14/11, child complained of runny nose, congestion, fatigue. Developed fever ranging from 100.5 degrees F - 103.3 degrees F. Symptoms continued through 10/17/11. Child was treated with MOTRIN alternating with TYLENOL. Also had one nosebleed.
Patient is a 66 yo female with a CC of inflammation of injection site s/p PNEUMOVAX 23 25 mcg/0.5 mL vaccination on 1 /30/18. HPI: Pt received injection in the left deltoid during the afternoon, pain and swelling worsened over the course of the evening. Pain is described as a 7/10 and as hot, tight and swollen. Patient tried acetaminophen and benadryl in an attempt to alleviate symptoms, which didn't help. Patient was afebrile overnight.
R sided facial flushing/fullness sensation x 22 hours after injection. 10mg PO decadron provided and 50mg benadryl PO.
Because I have the Prothrombin G20210A mutation the booster shot triggered my body to produce a PE (pulmonary embolism) 3 days after the booster on 9/23/2021. It started out with chest pain and landed me in the hospital. I do.t believe everyone will get this adverse side effect but others who share the Prothrombin G20210A gene mutation that I have the vaccine is likely to cause a pulmonary embolism or deep vein thrombosis.
This spontaneous report received from a medical assistant concerning a 1 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 26-APR-2017, the patient  received improperly stored dose of VARIVAX (dose, frequency not reported) (Lot: M041513, expiry date: 11-OCT-2018) reconstituted with sterile water diluent (unknown lot number and expiration date). No adverse effects reported. Temperature and Time frame: -14°C to -10°C for 9 hours 43 minutes, -14°C to -10°C for 15 hours 46 minutes, -14°C to -10°C for 12 hours 31 minutes. Previous temperature excursion was -14°C to -10°C for 6 hours 26 minutes. The call was because of data logger. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1706USA000291: US-009507513-1704USA014383: US-009507513-1706USA000289: US-009507513-1706USA000290:
Narrative: Pt is a 86y.o. male who died on 03/01/2021 w/ h/o gastroenteritis, HTN, AFib, prostate cancer, spinal cord lesion at C1-C4 level, ankylosing spondylitis, CDiff, Pressure Ulcer of Buttock stage 3, oropharyngeal dysphagia. Pt received Moderna Covid-19 Vaccination 2/2 on 02/08/2021. Pt died at Hospital on 03/01/2021 with physician reporting "Death was caused by: Cardiac Arrest". Unlikely that Moderna Covid-19 Vaccine caused/contributed to pt death.