chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lethargic; weak; colon cancer; This is a spontaneous report from a contactable consumer.  A 77-year-old male patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number: unknown) in Jan2021 (at the age of 77-year-old) as single dose for covid-19 immunisation. The patient had received the first shot in Dec2020.  Relevant medical history included Spinocerebellar ataxia for 20 years. The patient had Covid in Apr2020 and after he had Covid he had a flare up of prostatitis which is something he never had before. Concomitant drugs were unknown. The consumer reported that  after the first 2 vaccines in May2021, the patient was diagnosed with colon cancer.   Currently he was getting chemotherapy. The patient has had 2 treatments of chemo, and did wonderful after both.  After the vaccine he was lethargic and weak. The outcome of the events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101183820 Same patient, same drug, different dose/event
pt recvd vax;devel a pruritic,erythematous area w/ induration at inject site,lasting 4-5 hrs;
10SEP96 stiffened up, stared into space;fell backward-eyes open-hit head when fell then had a sz;resembled a grand mal-entire episode lasted approx 45sec;feet weak & shakey remainder of evening-for about 1hr;recovered spontaneously
temporary paralysis in legs and arms, symptoms were first notice at 4:00am , lasted about 5 hours. also felt nausea lasted about 10 minutes, chills and headache a few hours
I was awoke by pain in the back of my neck and right side of my body; I was awoke by pain in the back of my neck and right side of my body/ I try to lift up my head of the pillow and trying to lift my head of the pillow was extreme pain; I am little bit tired; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not provided) solution for injection, via an unspecified route of administration on 02Feb2021 at 1:00 PM at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got the Pfizer COVID vaccine at a drug store yesterday (02Feb2021) at 1:00 PM and everything was fine. After eating his/her dinner, the patient was a little bit tired and went to sleep at 9:00 PM. When the patient got up around midnight, he/she was awaken by pain in the back of his/her neck and the right side his/her body. The patient tried to lift his/her head of the pillow, but it was extremely painful. So, the patient pulled a smaller pillow afterwards and had to use his/her hand to lift the head to get the other pillow underneath the patient's head, but the pain was so bad. This morning, the  pain was not quite as bad but the patient still couldn't, like if the patient tried to sit up straight to turn the head to see something, it was like somebody hit him/her in the back of the head with the bat or like an object, like the patient was in a car accident or something. The patient was going to take ibuprofen (ADVIL) but was told that he/she could take paracetamol (TYLENOL) or ADVIL if you have a side effect, the patient went on the internet and some of the websites said that it could lessen the effectiveness of the vaccine, so he/she didn't take ADVIL because the patient did not want to weaken or lessen the vaccine. The patient wanted to know if he/she should take ADVIL; if ADCIL will erase the vaccine; or if it will be bad if the patient take ADVIL for pain. The patient clarified that he/she did not take ADVIL or TYLENOL yet. The outcome of the event pain was recovering and unknown for all other events.   Information on the lot/batch number has been requested.
Pfizer vaccine was administered outside of clinic- reported by patient- ? NO LOT NUMBER WERE SUPPLIED --------------------------------------------------------------------------------------------------------------------------------- ACUTE RESPIRATORY FAILURE 7/14/2022 HX OF INTRACRANIAL HEMORRHAGE HYPOXIA 7/14/2022 HX OF INTRACRANIAL HEMORRHAGE
After receiving SHINGRIX IM I developed a headache, severe chills, muscle pains and injection site pain. Also noted to have swollen lymph nodes under the arm where I got the shot. Symptoms have lasted 3 days now without improvement.
12 hours later, chills and shakes with no fever and significant body pain (strange, not like muscle aches, felt deeper and more acute). 12-18 hours later, I developed a cough and some tightness in my chest.  2 weeks post shot and the cough and tightness remain. Periodic bouts of fatigue.
Patient put a DOB of 6/10/2004 on his informed consent form indicating he was 16 years and 9 months old.  After coming back from an "off-site" clinic we entered his information into the pharmacy management system and noticed his DOB was 6/10/2005, making him ineligible for the vaccine.
Muscle pain lasting over 3 days at injection site, dizziness/light headedness lasting 30 minutes after shot, nausea lasting up to 30 minutes after shot, muscle stiffness lasting full day shot was received.
Patient was sitting in chair when she alerted Medic she was feeing dizzy and lightheaded. Patient had syncope episode lasting approximately 45 seconds. Patient did not strike her head and was placed in recovery position on the floor by two medics. EMS was called to facility. EMS cleared patient to return home with spouse.
dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Feb2021 (Lot number: EN6702) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "dizziness". Additional information: Within couple of days after the patient's 1st Pfizer vaccine, she had dizziness. It was off and on, most days especially in the morning.  No follow-up attempts are possible. No further information is expected.
STARTED WITH VOMITING AND DIARRHEA ON 11/26/2010.  PRESENTED IN OFFICE ON 11/27/2010 WITH A SOFT, MOBILE SAUSAGE-SHAPED MASS IN LLQ/MID-ABDOMEN.  SENT TO ER FOR EVALUATION.  INTUSSUSCEPTION FOUND AND TRIED TO REDUCE TWICE WITHOUT SUCCESS.  SURGERY DONE TO CORRECT.  ALSO DISCOVERED MALROTATION WHICH REQUIRED SURGERY.
Started with an aching left arm the day after the vaccine shot (22 Mar 2021), this lasted for about 4 days.  From 29 Mar developed aches through whole body, headache and . On  31 Mar  a shingles rash had started to develop.  Called wake med urgent care on 1 April suspecting shingles, which was confirmed by doctor and prescribed a 7 day course of  acyclovir (800g x 5 per day).  I did not mention to doctor that I had a Covid shot 10 days before the shingles appeared
Information has been received from a nurse concerning a "4th grader" female patient who was vaccinated with a first dose of Gardasil. The patient experienced pain in the injection site right after receiving her injection. It was unknown if she sought medical attention. The outcome was unknown at the time of this report. Additional information is not expected.
his right leg was getting paralyzed occurred after first and second shot/after his first shot he could not use his legs he had to use a cane/side effects went away in 4-5 days; after his first shot he could not use his legs he had to use a cane; This spontaneous case was reported by a consumer and describes the occurrence of MONOPLEGIA (his right leg was getting paralyzed occurred after first and second shot/after his first shot he could not use his legs he had to use a cane/side effects went away in 4-5 days) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Back surgery in October 2020. Concomitant products included WARFARIN, SINCALIDE, ATORVASTATIN, OMEPRAZOLE, HYDROCODONE and TESTOSTERONE for an unknown indication.    On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MONOPLEGIA (his right leg was getting paralyzed occurred after first and second shot/after his first shot he could not use his legs he had to use a cane/side effects went away in 4-5 days) (seriousness criterion medically significant) and WALKING AID USER (after his first shot he could not use his legs he had to use a cane). At the time of the report, MONOPLEGIA (his right leg was getting paralyzed occurred after first and second shot/after his first shot he could not use his legs he had to use a cane/side effects went away in 4-5 days) and WALKING AID USER (after his first shot he could not use his legs he had to use a cane) had resolved.        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.   No treatment medications were provided.  Company comment: This case concerns a male patient of unknown age with medical history of back surgery, who experienced the unexpected serious event of Monoplegia. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. the history of back surgery for unspecified indication remains a confounder considering that the underlying pathology may have contributed to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   This case was linked to MOD-2021-349164 (Patient Link).; Sender's Comments: This case concerns a male patient of unknown age with medical history of back surgery, who experienced the unexpected serious event of Monoplegia. The event occurred an unknown number of days after the first dose of mRNA-1273 vaccine. the history of back surgery for unspecified indication remains a confounder considering that the underlying pathology may have contributed to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Patient received expired dose from the lot number 013F21A; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired dose from the lot number 013F21A) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired dose from the lot number 013F21A). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired dose from the lot number 013F21A) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Health care professional (HCP) mentioned that there was incident because of miscommunication as a coworker said that there were some lot numbers whose expirations dates have been extended.  On 14 Apr 2022, the patient received 2nd booster expired dose from the lot number 013F21A.  Treatment information was not provided.
In the afternoon I noticed a scratchy throat and headache.  I got a cough and congestion with it.  I spiked a fever additionally.  5/20 I went to the doctor, who performed a Rapid COVID-19 test, positive.  Also did an At Home COVID-19 test, positive.  Doctor proscribed Paxlovid and advised to pick it up if symptoms got worse.  Symptoms have been steadily improving.   Only a cough and nasal congestion linger at time of reporting.
pt seen 6/4/99 had nl exam & no problems exist reported nasal congestion for over a month;also had oral thrush;congestion was felt to be ?secondary to milk allergy & recommended change to soy;given med for thrush;found dead in bed w/parent
arm hurts like I sprained a muscle; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts like I sprained a muscle) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for an unknown indication.     The patient's past medical history included No adverse event (No relevant medical history reported.). Concomitant products included PRAVASTATIN and LISINOPRIL for an unknown indication.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN IN EXTREMITY (arm hurts like I sprained a muscle). At the time of the report, PAIN IN EXTREMITY (arm hurts like I sprained a muscle) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       patient put diclofenac topical pain relief on her left deltoid but only helped temporarily.
Patient hospitalized the day after receiving COVID-19 vaccine (Moderna) booster.  Booster dose was also the wrong dose - given 0.5 mL dose (rather than 0.25 mL dose)  Discharge Provider: MD Primary Care Provider at Discharge: DO Admission Date: 11/11/2021 Discharge Date: 11/12/2021 HOSPITAL PROBLEMS:  Sepsis; Acute Hypoxic Respiratory Failure;  2/2 CAP;   AKI Chief Complaint:  Patient presents with FEVER:  COVID booster yesterday developed fever and shortness of breath this morning. Pt states booster was a full dose of the vaccine HOSPITAL COURSE  Patient is a 75 y/o man w/ PMHx of RA, Asthma, & HTN who is admitted to Hospital on 11/11/2021 for Sepsis 2/2 CAP.  Patient reports that he was of his usual health until this morning at 04:00 when he woke up with shaking chills and rigors.  He felt very feverish and had his wife call EMS.  The patient received his booster dose of Moderna vaccine for COVID-19 yesterday.  This was his 3rd vaccine and with confusion in the dosing the patient was given two half doses. Upon presentation emergency department the patient had a fever, tachycardia, and tachypnea.  He was mildly hypotensive.  Patient was requiring 2 L of oxygen via nasal cannula.  Blood work revealed mild AKI and otherwise relatively stable labs.  Chest x-ray demonstrated large hazy developing infiltrate in the right mid lung.  Patient was revised and 2 L of IV fluids with adequate response in his blood pressure.  He was placed on supplemental oxygen.  He was given 2 days of Rocephin and azithromycin.  He was able to be weaned to room air.  On day of discharge the patient ambulated the halls without need of supplemental oxygen.  He is discharged with continuation of Omnicef and Azithromycin to complete his Abx course.
A 95-year-old male with past medical history of hypothyroidism who presents today with chest pain.  Patient states that chest pain began at 10pm when he was lying in bed.  Patient called EMS at this time and was brought in.  Chest pain initially had improved but when I entered the room, he noted having his chest pain returning.  Patient states that it is left-sided and noted to be deep.  Pain involves the left arm at this time.  He denies pain in the left chest wall.  He has been to the emergency department 4 times in the last 3 months due to this chest pain. He states that the chest pain always goes away by the next day.  He has no prior cardiac history.  He had a positive COVID test on 10/1/2021. The patient notes that he is vaccinated for COVID-19 and is unsure of how he got infected. patient has no other questions or concerns at this time.
Very Sudden onset nausea and diarrhea with chills for about 2 hours.  Slowly subsided.  Also dizzy spell a few days later, lasted a couple of hours.
Case number PHEH2013US019090, is an initial spontaneous report received from a healthcare professional on 09 Sep 2013. This report refers to an 11 years old male patient. He received only Men C, Y, W-135 liquid conjugate component of MENVEO (batch number: A12092), intramuscularly without being reconstituted with Men A lyophilized conjugate vaccine component on 29 Aug 2013. No adverse event was reported following this administration error.
Tested positive for COVID-19 on 10/7/21 via PCR test.  Admitted to Hospital on 10/24/21 because of sudden paralysis of lower extremities.  Patient had evaluation including x-rays that showed evidence of acute aortic occlusion.  With the acute occlusion, patient had a left axillary to femoral and let to right fem-fem bypass done on 10/24/21.  Patient had been passing blood in her stool.  Expired at Hospital on 10/25/21 with cause of death reported;  Septic shock, Ischemic Bowel, Lower Limb Ischemia, COVID pneumonia.
Menactra was administered to somebody else, no AE; Initial information received on 24-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves an unkown demographic patient who received a dose of vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] lot number not reported via unknown route in unknown administration site on an unknown date inadvertently.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It is an actual medication error case due to wrong patient received product. It was reported that, vaccine was administered to somebody else.  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  Information on the batch number was requested.
Osteoarthritis flare up in her knee and arm; This spontaneous case was reported by a consumer and describes the occurrence of OSTEOARTHRITIS (Osteoarthritis flare up in her knee and arm) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 02SA21A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis.    On 22-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 OSTEOARTHRITIS (Osteoarthritis flare up in her knee and arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of 1 dosage form. At the time of the report, OSTEOARTHRITIS (Osteoarthritis flare up in her knee and arm) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.     This case was linked to MOD-2021-182342 (Patient Link).
Patient stated to having memory loss, dizziness, and other stroke-like symptoms, the day following the immunization. She did go to hospital was examined, had CAT Scan, and was released with no findings. Patient states she in now recovered, as on Monday 10/01/2018.
Patient was fine at 15 min and left the facility, after about an hour she was having trouble breathing and went to an emergency room.  They gave her prednisone, epinephrine, and benadryl.
pt felt Light headed after vaccination + laid down x 10" then felt better. Dangled Legs For a few minutes then Left office. In car w/Mother started to "not feel well, felt numb" the had LOC x 3-4 minutes per Mom w/Rigidity, jerking at waste. After event pt. started to cry, stated she felt heavy and needed 2 people to assist her out of car into home. Pt continued to state her "body felt heavy + tingly + Remembered shaking." Mother Report ~ 4' after event patient was speaking as if "she were drunk (like after having her wisdom teeth pulled) legs were weak + she needed help with ambulating upstairs. Slept well overnight but did report initially feeling "weird" Upon waking but felt better later in The morning. Hx of anxiety and vasovagal w/Blood work + orthotactic changes subjectively w/ position changes.
Muscle pain; Feels arthritis has worsen since taking the vaccine; Persistent Joint pain in shoulders, elbows, knees and hips / Joint Pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRITIS (Feels arthritis has worsen since taking the vaccine), ARTHRALGIA (Persistent Joint pain in shoulders, elbows, knees and hips / Joint Pain) and MYALGIA (Muscle pain) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis, Thyroid disorder and Cholesterol. Concomitant products included ATORVASTATIN for Cholesterol, LEVOTHYROXINE for Thyroid disorder, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced ARTHRITIS (Feels arthritis has worsen since taking the vaccine) and ARTHRALGIA (Persistent Joint pain in shoulders, elbows, knees and hips / Joint Pain). On 24-Mar-2021, the patient experienced MYALGIA (Muscle pain). The patient was treated with PREDNISONE for Joint pain, at a dose of 1 dosage form and HYDROXYCHLOROQUINE ongoing since an unknown date for Joint pain, at a dose of 200 milligram. At the time of the report, ARTHRITIS (Feels arthritis has worsen since taking the vaccine) outcome was unknown and ARTHRALGIA (Persistent Joint pain in shoulders, elbows, knees and hips / Joint Pain) and MYALGIA (Muscle pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Muscle and Joint pain occurred again on 7-Apr-2021 and 22-Apr-2021.   Dosage of Prednisone (treatment) was taken as 2X20 milligram tablet per day for next 7 days, then 1X20 milligram tablet per day for next 7 days, then again 1X10 milligram tablet per day for next 7 days, then 2X5 milligram tablet per day for next 7 days and then 1X5 milligrams and half 2 and half milligram tablet per day for next 14 days. If the pain did not go away then, 7 and half milligram.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Non significant Follow up appended for AE Contact Update On 27-Jul-2021: Significant follow up appended to AER, event. concomitant medications updated