chrisvoncsefalvay/vaers-outcomes huggingface dataset:
3x3 inch reaction around the injection site that was inflamed; injection site that was reddened; injection site that was hot; Initial information received on 04-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional via regulatory authority (under the reference 00796451).  This case involves an 8 years old male patient who had 3x3 inch reaction around the injection site that was inflamed (vaccination site inflammation) after receiving vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), Concomitant medication(s) and family history were not provided.  Patient had no other vaccines.  On an unknown date, the patient received a dose of suspect FLUZONE QUADRIVALENT (0.5 ml, total, lot UT7315MA and expiration date 30-jun-2022) via intramuscular route in the deltoid for prophylactic vaccination.  On an unknown date the patient developed a non-serious 3x3 inch reaction around the injection site that was inflamed (vaccination site inflammation), injection site that was reddened (vaccination site erythema) and injection site that was hot (vaccination site warmth) (unknown latency) following the administration of vaccine.  No laboratory data reported.  It was not reported if the patient received a corrective treatment.  The patient recovering from the reported events.  The reported assessed the causality of the suspect with the events as related.
Weakness starting 11/10/2021 at home.  Acute progressive weakness on 11/12/2021 prompting ER visit and hospitalization.  Transferred 11/14/2021 with diagnosis of Guillain Barre Syndrome on 11/15/2021.
Arthritis mainly in hands and wrists. Painful swollen joints in fingers and muscles in hands. Weakness in wrists and hands on both right and left.  Course of prednisone 10mg tablet 1 per day for 10 days started (10 days after worsening of symptoms) Has not subsided yet.
patient was inadverently administered second dose of prevnar instead of being administered pneumovax 23; type of product confusion that occured was unknown; no adverse effect; This spontaneous report was received from a pharmacist refers to a 66 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not provided. Approximately in November 2018 (reported as "last year"), the patient was vaccinated with first dose of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (dose, strength, #lot, expiry date unspecified) for prophylaxis. On an unknown date, the patient was inadvertently administered with a second dose of pneumococcal 13v conj vaccine (crm197) (PREVNAR 13) (dosing details unspecified) instead of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). It was also reported that, there was a possibility of product confusion might have occurred. The type of product confusion that occurred was unknown. No adverse effects were reported. Product quality complaint (PQC) was not involved.
Menstrual cycle 2 weeks early after having normal cycles. They continued to be irregular for several months.
Headache; Chest pains; high fever; body aches; chills; first dose 16Dec2020/ second dose 04Jan2021; This is a spontaneous report from a contactable pharmacist (the patient). A 21-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EL1284), intramuscularly in the right arm on 04Jan2021 at 12:30 PM (at the age of 21-years-old) as a single dose for COVID-19 immunization. The patient's medical history included COVID-19. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number EK5730), intramuscularly in the right arm on 16Dec2020 at 11:30 AM (at the age of 21-years-old) as a single dose for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 05Jan2021 at 12 AM, the patient experienced chest pains, high fever, chills, body aches, and headache. No treatment was given for chest pains, high fever, chills, body aches, and headache. The clinical outcome of chest pains, high fever, chills, body aches, and headache, was recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Patient reported feeling pain travelling down her left arm and up into her shoulder/neck 5 minutes after receiving her vaccine. The pain then continued to increase in intensity and travelled into her face. The patient was then encouraged to go to the emergency department (on-site), where she was evaluated. According to records, the providers in the emergency department noted "drooping" of the left side of her face. A full stroke work up was completed with negative results. The patient was eventually diagnosed with Bells Palsy and was treated with prednisone.
Confusion, aches, pains, increased heart rate.  Flushed face.  Sent to ER for eval and treat.
She received the vaccine, had achiness, was tired, but otherwise nothing severe.  The day after she had severe pain mainly in the biceps muscle and up into her neck like somebody had a knife in it, and when she tried to use it it was like somebody was turning the knife.  It feels like a bone bruise and not able to move the arm or use the arm.  She was on antibiotics as the doctor felt it was an  infection, and it felt better and tone down the symptoms while on it.  Has been off of them 2 1/2 days ago and is now getting worse.   She took her regular medicines, and called her doctor on the 4th day and he advised her to ice the arm, and has talked to him several times on the phone.  She is still having some issues with the arm due to the pain and can only raise her arm about 1/4 way up without the pain getting severe.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. There was no pertinent medical history, concurrent conditions and drug reactions/allergies reported. On an unknown date the patient was vaccinated with GARDASIL, 0.5 ml intramuscular (dose number, lot# not reported). No concomitant medications were reported. The nurse reported that 40 patients were administered GARDASIL that has been stored improperly. No adverse effects reported. Additional information has been requested.
About 15 minutes after receiving dose 2 my neck got stiff.  It progressed for several days.  I started to have fever the same night.  My fever lasted for three days.  I had a headache, muscle aches and joint pain.  The worst symptom was the allergic reaction at the injection site.  It got be the size of a golf ball, under the skin.  It was swollen, hard, red, hot and spreading.  I noticed this allergic reaction on day two after the injection.  I went to the emergency room on August 27th due to the allergic reaction.  I thought it may be infected.  I was also having tachycardia and my blood pressure spiked.   My fever peaked at 101.00 and had a bit of diarrhea.  As of today, I still have body aches and fatigues.
This spontaneous report as received from a registered nurse refers to 3 patients of unknown age and gender. On an unknown dates, the patients were vaccinated with doses of VARIVAX (dose, frequency, route of administration were not provided; lot # K021487, expiration date 03-NOV-2016) that had been improperly stored. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
Nosebleeds (7 total from  the 10th to present), headaches, and lightheadedness.
**DO NOT KNOW which type of flu vaccine was given. Arm on which flu shot was administered has been hurting for three weeks now. Very difficult to drive, put on clothing, use laptop at work. Pain is further aggravated after exercise. Trouble sleeping on arm. Would wake up to arm throbbing.
Case number PHEH2011US00778 is an initial spontaneous report received from a health care professional on 03 Aug 2011. This report refers to an adolescent female patient. She was given only the MenA powder conjugate component of MENVEO (batch number: unknown) reconstituted with a sterile diluent instead of MenCWY liquid conjugate component, intramuscularly on 30 Jul 2011. No other adverse reaction was reported.
On unspecified dates, the vaccinee completed "a series of injections" of Lymerix. One year later, the vaccinee experienced hearing loss, "vibrations" and pain. The vaccinee underwent an unspecified surgical procedure. As of 2/28/02, the outcomes of the events were unknown.
Got Covid; getting sick but test was negative; she is still kind of congested from Covid; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Got Covid), ILLNESS (getting sick but test was negative) and NASAL CONGESTION (she is still kind of congested from Covid) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L213) for COVID-19 vaccination.     Concurrent medical conditions included Penicillin allergy, Drug allergy (cephalexin), Allergy to antibiotic (clindamycin) and Sulfonamide allergy (sulfa drugs).    On 21-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (Got Covid), ILLNESS (getting sick but test was negative) and NASAL CONGESTION (she is still kind of congested from Covid). At the time of the report, SUSPECTED COVID-19 (Got Covid), ILLNESS (getting sick but test was negative) and NASAL CONGESTION (she is still kind of congested from Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2022, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Caller did not test positive for Covid diagnosis but her boyfriend did and she was getting sick but her test was negative last week when she got tested. Caller says she was pretty sure that she got it.   It was reported that patient received a cervical cancer vaccine in junior high12 years ago.  No treatment drug were reported.   No concomitant medication were reported.  Company comment:This spontaneous case concerns an adult female patient, with no relevant medical history, who experienced the non-serious, unexpected AESI event of suspected COVID-19, and non-serious, unexpected events of illness and nasal congestion. Events occurred on unknown date after she received her first dose of mRNA 1273 COVID-19 Vaccine. Patient felt sick and was congested. She suspected she had COVID-19 infection due to exposure to a COVID-19 positive patient however her SARS-COV-2 test was negative. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns an adult female patient, with no relevant medical history, who experienced the non-serious, unexpected AESI event of suspected COVID-19, and non-serious, unexpected events of illness and nasal congestion. Events occurred on unknown date after she received her first dose of mRNA 1273 COVID-19 Vaccine. Patient felt sick and was congested. She suspected she had COVID-19 infection due to exposure to a COVID-19 positive patient however her SARS-COV-2 test was negative. The benefit-risk relationship of mRNA 1273 vaccine is not affected by this report.
Rapid heart rate noticed around 9:30pm on 4/14/21 (date of injection) as if right now 8:59 4/16/22 seems to be getting better. Tightness is shoulder and left side if chest   The chest tightness is off and on.
Felt tired; Headache; My temperature running high; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown, Expiration date was not reported), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Stated that, when probed for the concern, the patient had got the 1st Vaccine last Tuesday on an unspecified date and felt a little tired for the first 2 days but like noticed yesterday and today on an unspecified date, the patient had been having headache, just really fatigue and the patient went to get hair cut today and they screened the temperature and they told, the patient was running a bit high. Stated that, was this, it's been about 5 days, the patient was just wondered whether it was normal side effect or was there something the patient should be concerned about like getting tested. When paraphrased the concern, the consumer stated as yes and the consumer was informed about the Role of Drug Safety and Medical Information Department. When probed further question, the consumer stated that, actually the consumer did not had 10 minutes time to spare, no. Stated that, as the consumer was not willing to proceed the call, product details (LOT#, expiration date, NDC# and UPC#), pharmacy details and treatment could not be probed over the call. The outcome of the events was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Inflamed lymph nodes on  left side; Entire arm pit area swelled up; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: ER8733), via an unspecified route of administration in the left arm on 28Mar2021 at 08:15 (at the age of 34-year-old), as a single dose for COVID-19 immunisation. Medical history included Hashimoto disease and the patient did not have a history of allergies to any food or medications or other products. Concomitant medications included levothyroxine sodium (SYNTHROID) and ethinylestradiol, norgestrel (CRYSELLE) for an unknown indication from an unknown date. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: EN6205), via an unspecified route of administration in the left arm on 07Mar2021 at 08:30 (at the age of 34-year-old), as a single dose for COVID-19 immunisation. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Mar2021 at 21:00, the patient experienced inflamed lymph nodes on left side and entire arm pit area swelled up. The patient reported as the events were lasted 3 days and then went away and once the inflammation went down patient felt fine. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the events. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of inflamed lymph nodes on left side and entire arm pit area swelled up were recovered on an unknown date in 2021.  No follow-up attempts are needed. No further information is expected.
Lightheadedness the day before and rash that started on left side and then moved to chest, face and back.
I had fever and fatigue. I had a fever of 100 degrees or more for a couple of days. I was very fatigued like I had the flu. I was really fatigued. I was scared to take anything so I remained in bed until the symptoms. All symptoms were gone after 2 days.
At 6:35pm on 9/24/2021 employee reported by telephone that he believed he was having a reaction to the vaccine he had been given earlier that day.  He reported that he was experiencing a fever, nausea, and vomiting.  Employee was advised to seek medical care from his own HCP if he felt the need to, or if symptoms persisted.
5/4 35y.o. G1P0 at 35w1d by 8wk US who presents to triage for leaking of fluid since 1100.  5/5 SVD baby boy
After vaccines given immediately started wheezing & short of breath.  Pt felt anxious & screamed - gave 1.25 XOPENEX through nebulizer to treat wheezing - pt left 15 mins after treatment - sounded good.
Day after vaccination I have intense anxiety about nothing. My heart rate feels much higher and more intense. My chest feels incredibly tight and when I let my thoughts wander I become increasingly worried about nothing and hyperfocus on the tight feeling in my chest. I can end up feeling disassociated from myself not really knowing what's going on. Never had any history of anxiety before this. I only feel relief when I distract myself, so I lose a lot of sleep because of it. I end up feeling restless and can't sit still if I end up in one of these cycles.
Very fussy, leg swollen red and warm to touch. TYLENOL & BENADRYL given. Ice pack applied.
Extremely painful/sore arm at the injection site occurred approximately 13 hours after the injection. Approximately 17 hours after injection, I experienced body aches in my lower back, hips, thighs, knees, and calves. I also began experiencing alternating and intermittent chills and sweats along with a mild to moderate headache. All of the previously mentioned symptoms lasted approximately 24 hours. After 24 hours passed, I experienced some coughing for approximately 12 hours before it passed.
Rash developed on face, chest, abdomen, arms, back, legs on 4/11/06, blanching non resolved.
Acute Bell Palsy, noon on 11/15/06. Left sided. Neuro exam normal. 12/19/06 Received medical records from reporter/provider which reveal patient in good health on day of vax.  Next visit was 11/16/06 which revealed that on 11/15 patient abruptly developed droop of left face, smiling only on right side, decreased taste on left side.  Left eye would not close tightly & could not raise left eyebrow.  Treated w/eye ointment. Final DX: Bells Palsy.
Soreness of the right upper arm.  After a couple of weeks started to feel a tingle in the hands with a constant ache.  The arm has sharp pain that periodically goes down the arm. Also have some problems with lifting and moving the arm in certain motions.  Consulted my family doctor today 9-1-2011, he said that there is some muscle weakness and some nerve damage.  At this time he has set me up with a neurologist to have an EMG done to test the severity and to further diagnose.
Approximately 15 minutes post immunizations patient began to have symptoms that included:  diaphoresis, skin became pallor, complained of drowsiness.  Blood pressure was 90/64, O2 - 99% and HR - 80 bpm.   Patient was provided juice and crackers, within minutes symptoms subsided.
This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age and gender. No information regarding the patient's medical history or concurrent conditions was provided. On unspecified dates, the patients were vaccinated orally with improperly stored doses of ROTATEQ oral liquid (lot# K016263, expiry date 26-JUL-2016; exact dose was not reported). There were no concomitant therapies reported. No adverse effects were reported. There was no product quality complaint involved. This is one of several reports received from the same reporter. Additional information has been requested.
18OCT became fussy; 22OCT ran temp between 102-104 to 105 was put on APAP drops for 3 days; 23OCT went back to MD, thought maybe had ear infect; took urine sample;
On Sunday April 11, 2021, around 1:30 pm I started to feel so tired and exhausted. I needed to go to bed and we went home I fell asleep till 8:30 pm, then woke up thinking I wasn't going to be able to sleep that night. I got up and did a few things around the house then I was to exhausted to do anything else and went back to bed at 9:10 pm.  Woke  up the next morning Monday April 12, 2021 at 4:40 am with the room spinning. I have had Vertigo in the past, as a matter of fact I had got Vertigo so bad when I myself got COVID-19 back in November 2020. My head was spinning all day and then I ended up getting  a terrible headache. I took Tylenol & Dramamine and helped a little but still had a slight headache with Vertigo.  The next day I called my doctor because still woke up with Vertigo and a slight headache, saw him Tuesday April 13th and he worked on me and felt better the next day. Woke up Thursday April 15th with still some symptoms and still having slight headache & Vertigo.
Nothing happened until 7 pm when went to remove dot sized bandage, noticed red rash area on either side of bandage. Then the area got up to a golf ball sized red rash and a semi hard knot under the skin appeared with tenderness.
Patient received the Pfizer booster vaccine at our facility on Thursday 9/30/21.  On Friday and Saturday the next two days was in bed with body aches, headache, felt " awful" both days.  Sunday felt better but was winded and short of breath, had dull chest pain sternal area.  Heart rate was 160's.  Heart rate through the day was 130-160's.  Monday, Dr.  was seen and labs ordered and EKG and ECHO completed by cardiology Dr. Ordered Motrin for possible myocarditis 3 times a day.  Still having 110-130's heart rate when walking and 90-110 when sitting.  Motrin has assisted the chest discomfort.  Still awaiting ECHO results.
T104.1F, screaming >4hrs, vomiting 3hrs after injection, hypotonic was seen in ER 9/7 & Dr. office 9/8. Hypotonia. Fever, screaming SYND, vomit. 7 day follow up.
Initial report received from a vaccine provider on 07 January 2013. This case is not medically confirmed as the reporter was not identified as a healthcare professional or not. The report involves a cluster of 6 children from the same reporter and same lot number UH753AB. This case captures one of the children and the other children are captured in cases 2012-11111, 2013-00526, 2013-00528, 2013-00529 and 2013-00530. A two year-old female patient whose illness at the time of vaccination was reported as "N/A" and past medical history was unknown had received a dose of FLUZONE (lot number UH753AB, IM) on 04 December 2012 and tested positive for Influenza A and influenza B via the Binaxnow quick test on 10 December 2012. The patient had received on 09 October 2012 a dose of FLUZONE (lot number, route and site of administration not reported) and a left leg dose of ACTHIB, lot number UH624AH (sanofi pasteur SA lot number H1153-1) (route of administration not reported). On 02 November 2012, the patient received a left leg dose of IPOL, lot number H1340 (route of administration not reported). The patient's outcome was not recovered. Documents held by sender: none.