chrisvoncsefalvay/vaers-outcomes huggingface dataset:
feeling a little funny; feeling a little tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 54-year-old female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 01Mar2023 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Dose 1, lot number unknown), for COVID-19 immunisation; Moderna covid-19 vaccine (Dose 2, lot number unknown), for COVID-19 immunisation; Bnt162b2 (Dose 3 (booster), single, lot number unknown), administration date: 2021, for COVID-19 immunisation. The following information was reported: FEELING ABNORMAL (non-serious) with onset 2023, outcome "unknown", described as "feeling a little funny"; FATIGUE (non-serious) with onset 2023, outcome "unknown", described as "feeling a little tired".  Additional information: the patient reported that she initially received a two injection series of the Moderna COVID-19 vaccine, and then she received two Pfizer covid-19 boosters after that, the first Pfizer booster in 2021 and then another Pfizer booster on 01Mar2023. The patient stated that with the Pfizer covid-19 booster she got on 01Mar2023, she experienced feeling a little funny the first day and feeling a little tired for a couple of days.  The information on the batch/lot number for bnt162b2, bnt162b2 omi ba.4-5 has been requested and will be submitted if and when received.
fever 101.3, chills, headache, extreme fatigue, soreness at injection site
gave pt Janssen shot at about 3:05 pm 7/6/21. after 5 minutes pt asked for water. Staff saw that the pt was pale and alerted me to that. Pt told me he was feeling dizzy. Had pt put his head down to his knees while I questioned him about other symptoms. Pt reported no nausea, no feeling of fullness, no itching, no headache, no other signs/symptoms. Dizziness abated after pt had his head down for 2-3 minutes. BP taken at 3:13 pm was 133/106 pulse 59. Explained to pt that I needed to continue observing him for signs of adverse rxn for a total of 30 minutes though he indicated that he was feeling better. pt agreed. Let pt go after the 30 minutes was up. counseled pt to mention the dizziness if ever he needs a Janssen "booster" in the future.
no adverse effect; multiple patients were vaccinated with improperly stored VAQTA on multiple dates; This spontaneous report was received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 26-DEC-2018, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) lot # R002086, expiry date 22-APR-2019 for prophylaxis.  No adverse event was reported. Previous temperature excursion was reported. Data logger was involved.; Sender's Comments:  US-009507513-1907USA000067:
On 06/14-fever onset at 4pm with 102 deg. F. On 06/15, vomiting onset during the night on 06/15, 06/16 awoke with 104 deg. F. temp was seen by the physician who thought of posible virus. On 06/17 vomiting continued with fever and seemed to be lowering had seizure at 1pm. Was seen by the physician, still thought to be viral. Sent for blood work, white blood count almost 20,000, blood culture found to be negative. Administered Roftussin antibiotic shot. Temp no longer continued until 06/26. Staring seizure on 06/18 at 6pm and two more shots of the antibiotics were given on 06/18 and 06/19.
I have been bleeding since March 12th, the day I got my vaccine.  Last night I started to bleed heavily, like over flowing my pad.  Its May 13th!
Injection site soreness immediately following the injection and a headache soon after. By 8pm I began experiencing some brain fog and soreness increased significantly.
Received the Covid Vaccine on 01/07/2021. a few hours after, I noticed I had a headache, soreness at site radiating to neck, & became itchy mostly on my ribs.  Later, noticed that the locations I was itchy I had broken out into hives. Took Zyrtec. REACTION TYPE - itching/hives. Seen and discharged to Allergist.
Very fussy, leg swollen, no abscess 5 inches x 2 1/2 inches.
Patient complaining of extreme pain in injection site for the past month tried using Ibuprofen for pain relief nothing helps patient states.
Arm soreness same day. Next day, had no range of motion without having excruciating pain- unable to hold child, do my hair, put on a bra, shake hands, etc. I had two children WITHOUT pain medication and this was the worse!
This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 78-year-old male patient who received SHINGRIX (batch number 95LX9, expiry date 22nd February 2021) for prophylaxis. On 10th August 2018, the patient received SHINGRIX (intramuscular) .5 ml. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site pain, neck pain, shoulder pain and ear pain. The patient was treated with ibuprofen. On an unknown date, the outcome of the injection site pain, neck pain, shoulder pain and ear pain were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, neck pain, shoulder pain and ear pain to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX on unknown deltoid and later on in August 2018, experienced pain at the injection site, pain behind the ear and down the side of the neck and shoulder of the arm where the vaccine was given. These events had not resolved till the time of reporting.
Information has been received from a registered nurse refers to unknown number of patients of unknown age and gender. The nurse reported that on unspecified dates, an unknown number of unspecified patients were inadvertently administered ROTATEQ (lot#, route and dose unknown) which had been improperly stored. No adverse effects reported. There was no concomitant medication and no pertinent medical history reported. The outcome and action taken were not provided. This is one of several reports from the same source. Additional information is not expected since the reporter did not allow to follow up.
Arm started hurting; Lump started hurting; it is two times the size it was before; Lump got bigger; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm started hurting), PAIN (Lump started hurting), SWELLING (it is two times the size it was before) and LYMPHADENOPATHY (Lump got bigger) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Renal agenesis and Lymphoma.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced PAIN IN EXTREMITY (Arm started hurting), PAIN (Lump started hurting), SWELLING (it is two times the size it was before) and LYMPHADENOPATHY (Lump got bigger). At the time of the report, PAIN IN EXTREMITY (Arm started hurting), PAIN (Lump started hurting), SWELLING (it is two times the size it was before) and LYMPHADENOPATHY (Lump got bigger) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient does not take any medications. Concomitant product information was not provided. Patient already had a lump doctor described as "lymphoma" on the bone of her left shoulder next to her neck, but it was very small.
Afebrile seizure lasting approximately 10-15 sec, tonic-clonic posturing, postictal lethargy approximately 30 min. This happened 47 hrs after influenza vaccine (on 9/8/12).
Died since taking your COVID vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEATH (death, medically significant), outcome "fatal", described as "Died since taking your COVID vaccine". The date and cause of death for the patient were unknown. It was not reported if an autopsy was performed. Additional information: Reporter also reported that he/she has countless sick friends thanks to it. Stated that the clock was ticking, the truth will prevail.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300020087 as same reporter/drug/event, different patient;; Reported Cause(s) of Death: Died since taking your COVID vaccine
Erythema, swelling, warmth and mild induration at injection site began approximately 2 hours after injection placed. Parent gave MOTRIN.
This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act refers to a 17 year old female patient. The patient's historical drug included TYLENOL WITH CODEINE. The patient's concurrent condition included fatigue. On 24-MAY-2016, the patient was vaccinated with the first dose of GARDASIL 9 (lot # L025737, expiry date: not reported) via intramuscular route in the right arm for prophylaxis. Other suspect therapies included TRUMENBA (lot # J28923, intramuscular in the left arm) and meningococcal conj vaccine (unspecified) (dose 1, lot #U5272AA, intramuscular in the left arm). On the same day after vaccination, the patient experienced chills, subjective fever, cold intolerance, weakness, nausea, vomiting, muscle aches, painful joints, dizziness, pain and tingling/numbness to lower extremities. On an unknown date, she was hospitalized. An unknown lab test confirmed conversion disorder on 24-MAY-2016. The outcome of the events were reported as recovered. Causality assessment was not provided. Additional information is not expected from the Agency as follow up information cannot be obtained.
The 2nd morning after my shot there was a golf-ball sized swelling of my lymph nodes near my collar bone.
4/28/2021 I was seen at Hospital ER with Altered Mental Status, Dysarthria & word finding.  Labs , CT< MRI were done and I was sent home.  I was seen Friday at Primary and TOday MOnday 5/3 with Neuro again  I am off till 5/10 and this is realted to COVID Shot am adivsed if I do get this second does to go on a friedy as I will need the extra resting and may end up sick again.
Patient states after receiving her second dose of Shingrix vaccine, she initially experienced a large knot under the skin that was painful to the touch. The knot has gotten smaller over the last two months but patient states that it is still present and is still painful. She experiences pain when reaching and holding, such as when she opens the mailbox as well as when pressure is applied to the area.  Patient has made her primary care physician aware of the issue but no treatment was performed.
This spontaneous report as received from a registered nurse refers to a patient of unknown demographics. The patient's concurrent conditions, medical history, drug reactions/allergies and concomitant therapy were not reported. On 11-JUL-2018, the patient was vaccinated with improperly stored doses of PROQUAD either from lot # R002939, expiry date: 29-JUL-2019 or lot # R006218, expiry date: 28-AUG-2019 (dose, frequency and route were not reported) for prophylaxis. Sterile diluent (DILUENT MRK INJ) was properly stored. No adverse effects were reported. No product quality complaint was involved. The PROQUAD was stored in temperature of 15 degree Fahrenheit (F) to 46 F for 14 hours on 16-JUN-2018. No previous temperature excursion was reported. A digital data logger was involved. This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1808USA001261: US-009507513-1808USA004381: Original Case : 1808USA001261 US-009507513-1808USA004382: Original Case : 1808USA001261 US-009507513-1808USA004380: Original Case : 1808USA001261 US-009507513-1808USA004379: Original Case : 1808USA001261 US-009507513-1808USA004376: Original Case : 1808USA001261 US-009507513-1808USA004378: Original Case : 1808USA001261 US-009507513-1808USA004383: Original Case : 1808USA001261 US-009507513-1808USA004384: Original Case : 1808USA001261 US-009507513-1808USA004385: Original Case : 1808USA001261 US-009507513-1808USA004362: Original Case : 1808USA001261 US-009507513-1808USA004386: Original Case : 1808USA001261 US-009507513-1808USA004387: Original Case : 1808USA001261 US-009507513-1808USA004388: Original Case : 1808USA001261 US-009507513-1808USA004363: Original Case : 1808USA001261 US-009507513-1808USA004364: Original Case : 1808USA001261 US-009507513-1808USA004389: Original Case : 1808USA001261 US-009507513-1808USA004390: Original Case : 1808USA001261 US-009507513-1808USA004391: Original Case : 1808USA001261 US-009507513-1808USA004392: Original Case : 1808USA001261 US-009507513-1808USA004393: Original Case : 1808USA001261 US-009507513-1808USA004394: Original Case : 1808USA001261 US-009507513-1808USA004365: Original Case : 1808USA001261 US-009507513-1808USA004395: Original Case : 1808USA001261 US-009507513-1808USA004396: Original Case : 1808USA001261 US-009507513-1808USA004366: Original Case : 1808USA001261 US-009507513-1808USA004367: Original Case : 1808USA001261 US-009507513-1808USA004368: Original Case : 1808USA001261 US-009507513-1808USA004397: Original Case : 1808USA001261 US-009507513-1808USA004398: Original Case : 1808USA001261 US-009507513-1808USA004399: Original Case : 1808USA001261 US-009507513-1808USA004400: Original Case : 1808USA001261 US-009507513-1808USA004369: Original Case : 1808USA001261 US-009507513-1808USA004370: Original Case : 1808USA001261 US-009507513-1808USA004401: Original Case : 1808USA001261.
Client's daughter described events to me. Stated mother experienced tingling, weakness in legs about 7-14 days after receiving 2nd Covid vaccine. Also spoke with client for a few minutes. Stated could only walk a few minutes then legs felt like they were paralyzed and became really hot feeling. States toes felt like they were curling under left foot. Daughter took mother (client) to ER on Feb. 17 (after this had been going on for 4 days). Client was not admitted to hospital. Client stated no adverse events noted with 1st Pfizer Covid Vaccination. Client & daughter stated that client had bladder infection 1 week after receiving 2nd Covid vaccination. Client states problem with legs improving each day.
Shingles started 2/11/2021.  Also had urinary issues.  Notified PCP 2/18/2021.  Started 7 days Valacyclovir 1 G / 3x day and 10 days Ciprofloxacin 500 mg / 2x day on 2/18/2021.  Started 6 months Tamsulosin .4 mg /  1x day on 3/22/2021.
Fever started throughout the night and went up to 102 degrees. Large itchy bumps/hives started on her bottom the next morning. Throughout the course of 04/24/2012 child developed diarrhea, very tired and hives continued to spread throughout her body covering both her arms completely, her face and both her legs. Also complained of pain in her ankles. Was advised to administer Benadryl and monitor. Condition got better within the following 24 hours. Benadryl did help with the itching and hives were gone within approx. 28 hours of initial outbreak.
Increased anger and aggression, less patience. Level of anger has increased as well to the point of heart palpations.   An increase in libido.
1130  states that feeling of tingling  both hands and denies other symptoms. VS   BP 124/72,  HR 79,  Spo2 100 RA  1136  Denies tingling on both hands. 1140  VS BP 118/68,  HR 63,  Spo2 100 RA  1145  Checked out
Info has been received from a registered nurse in a clinic concerning an approx 20 year old female with no known drug allergies and asthma who on 11/05/2002 was vaccinated with pneumococcal vaccine 23 polyvalent. That same day medication included a dose of the influenza virus vaccine in the opposing arm. Subsequently the pt developed a small number of reddened welts that were approx 10 cm in diameter and were hot to touch. The pt sought unspecified medical attention. Additional info has been requested.
After receiving the vaccine I noticed I was having dizziness. Then I started having brain fog, memory issues, vision issues, and headaches. I have difficulty tracking and scrolling on my computer and my cellphone. I have to be careful with movement because I can become dizzy and lose my balance. I have light flashing in my vision. I told my neurologist. She sent me to an Ear, Nose and Throat doctor. I had an evaluation for an inner ear balance issue and it turns out I didn't have that. The doctor said I most likely have a vestibular migraine. I was prescribed Cyproheptadine. Since I started taking that medication my symptoms have resolved about 99%.
16JUn minor presentation of rash;17JUN urticaria presentation 5-6cm wheals over trunk, legs & arms;
Got Covid after first dose; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Got Covid after first dose) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history was reported.).    On 20-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced SUSPECTED COVID-19 (Got Covid after first dose). At the time of the report, SUSPECTED COVID-19 (Got Covid after first dose) outcome was unknown. Unknown      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported. Patient needed to push the second dose. Patient finishes quarantining on 17-Apr-2021, the date of her second dose.
lymph nodes in my neck at very swollen; This is a spontaneous report from a contactable consumer or other non-healthcare professional. A patient of unspecified age and gender received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection), dose 2 via an unspecified route of administration on 17Mar2021 (Batch/Lot number and Expiry date was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced lymph nodes in my neck at very swollen. It was reported that the patient had a reaction with the lymph nodes in my neck at very swollen and the doctor sent me for two needle biopsy's and one surgical biopsy and was wondering if the patient was allergic to 'penicillin' (Further not clarified) but actually wanted to know what was there in the shot that the patient took. Further probing could not be done as consumer was unwilling to complete the report and wanted to transfer the call to the Pfizer Medical Information Department. Hence limited information was available over the call. The clinical outcome of the event was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
9/8/2016-VACCINE ADMINISTERED. 9/9/2016-PATIENT RETURNED TO PHARMACY. SHE HAD AN INJECTION SITE RASH..IRREGULAR SHAPE ABOUT 2-3 INCHES ACROSS.  EXPLAINED THIS WAS POSSIBLE SE. 9/10/2016-PATIENT RETURNED TO PHARMACY AGAIN.  CENTER OF RASH HAD DARKENED CONSIDERALBY AND SHE COMPLAINED OF GENERALIZED EXTREME ITCHING.  PROVIDED PATIENT WITH DIPHENHYDRAMINE AND INSTRUCTED HER TO CALL HER PCP.
same afternoon of vax rt leg-entire leg- was red & swollen; inject site had lump the size of an apple; lasted 24 hrs-redness lasted another 24 hrs; slept a lot; no fever;
Early lesion - widespread (vesicular on abd) even in scalp. No ASA, no ibuprofen calamine Benadryl PRN. Out of school one week.
Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Additional Details: pt was fasting for couple off days. he faintyed for a while. called 911. he was fine. everything normal. pt went at home
Pfizer covid 19 vaccine lot # FJ6369 administered beyond use date 03/25/2022, administered on 04/05/2022
About 24 hrs after receiving H1N1 injection vaccine; he developed colicky centralized heavy sensation in chest. He was admitted to hospital and R/O fu MI.   12/30/09:  Hospital and primary care records received for dates of service 12/17/09 to 12/29/09.  Dx:  Atypical chest pain.  Developed retrosternal chest pain with pressure associated with some SOB.  Presented to the ED and given nitroglycerin and pain partially resolved but did not go away completely so pt. was admitted for chest pain, r/o ACS.  Discharged the next day on Aspirin and Simvastatin.
flu like symptoms; severe headache; terrible body aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (severe headache) and MYALGIA (terrible body aches) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040C21A, 024M20A and 029L20A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised, Heart disorder and Lung disease. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication.   On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (severe headache) and MYALGIA (terrible body aches). At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), HEADACHE (severe headache) and MYALGIA (terrible body aches) outcome was unknown.            Treatment medication was not reported.   This case was linked to MOD-2021-295648 (Patient Link).
Post vax, the pt complained of lump, tenderness at injection site; occasional shooting pains down arm. Site was warm. Pt received ice to injection site for 30 minutes.
Headache; moderate joint and muscle pain; muscle pain; This is a spontaneous report from a contactable other healthcare professional (HCP) reporting for herself. A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at left arm on 14Jan2021 12:45 at single dose for covid-19 immunization. The COVID-19 vaccine was administered at Clinic/Administration facility. Medical history included High blood pressure, fibromyalgia, psoriatic arthritis. Patient was not pregnant. Concomitant medications included lisinopril, cyanocobalamin (B12), pyridoxine hydrochloride (B6) and Multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced Headache and moderate joint and muscle pain lasting 16-18 hours on 15Jan2021 06:00, treated with 800 mg ibuprofen every 4-6 hours. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of the events was recovered on 15Jan2021.   Information on the lot/batch number has been requested.
Patient received a Covid Pfizer vaccine but was originally given Moderna (2 doses) and should not have received Pfizer dose
12 days after my booster shot, I started getting hives. It started slowly at first, but now on day 3 it's full-blown hives. Red, really itchy, in some places swollen and painful. Some hives are disappearing and reappearing, others are just staying put. They're all over my body. Antihistamines aren't helping.
Had high fever and vomiting after rotavirus vaccine on 10/28/09->10/29/09.