chrisvoncsefalvay/vaers-outcomes huggingface dataset:
felt comatose; I spiked a 103.3 fever; I was barely able to move; body was aching; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 18:00 (Batch/Lot number: unknown) at the age of 27 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 03:00 PM), administration date: 20Apr2021, when the patient was 26 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 23Mar2021, when the patient was 26 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (medically significant) with onset 02Dec2021 18:00, outcome "unknown", described as "Booster"; COMA (medically significant) with onset 02Dec2021 20:00, outcome "recovering", described as "felt comatose"; PYREXIA (non-serious) with onset 02Dec2021 20:00, outcome "recovering", described as "I spiked a 103.3 fever"; MOBILITY DECREASED (non-serious) with onset 02Dec2021 20:00, outcome "recovering", described as "I was barely able to move"; PAIN (non-serious) with onset 02Dec2021 20:00, outcome "recovering", described as "body was aching". The patient underwent the following laboratory tests and procedures: body temperature: (02Dec2021) 103.3. Therapeutic measures were not taken as a result of coma, pyrexia, mobility decreased, pain. The clinical course was reported as follows: "spiked a 103.3 fever and felt comatose. I was barely able to move and my body was aching so badly I had to call for help. The fever last 24 hours without relief but my symptoms took a full 3 days to get back to normal overall". The patient had no covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Bilateral Flank pain, with greater pain on the right side starting mildly on 1/1/2022 when I woke up, the pain increased in intensity until 1/5/2022. On 1/5/2022, 1/6/2022, and 1/7/2022 intermittent hematuria. On 1/7/2022 the bilateral flank pain began to lessen and hematuria became brown in color. It is still 1.7/2022 so symptoms have not yet fully resolved.
First sign was 3 small bumps on my face. No treatment because I didn't associate it at first with the shot.
Administered invalid dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered invalid dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered invalid dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered invalid dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications information was reported. No treatment medications were provided.  As  reported drew up Moderna yesterday morning at 9:35,  clinical staff forgot to discard the extra doses  yesterday and another nurse just gave one of those doses.
Some aching joints; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 63-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN62041, Expiration date: unknown), via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was 63 years) as dose 1, single for COVID-19 immunization. The patient's medical history included Hypertension, arthritis, mostly great health and allergic to flagyl, pollen, melon, some shellfish, latex. The patient received losartan and amlodipine as concomitant medications or other medications in two weeks. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Post the vaccination, the patient has not been tested for COVID-19. On an unspecified date the patient experienced some aching joints. Event was non serious. No treatment was received for the adverse event. The outcome of the events was resolved.  No follow-up attempts are needed. No further information is expected.
Flu like for 24 hours.  Starting at 8am I was very lethargic. Absolutely no energy. Progressed to terrible headache, had slight fever and chills. After sleeping from 1pm 3/18 to 6am 3/19 I awoke and felt 100 percent better. Still felt a little tired throughout Sunday 3/20 but not to the point that I couldn't function.
1/11/21: neck and shoulder stiffness and arthritis-like pain starts and continues until Prednisolone dose pack 4/28/21.  Stiffness and pain resumes in May-July but not as bad. 1/17/21: one week after 1st vaccine see large (egg size) swelling at injection site that lasts a few days. 1/20/21: numbness and tingling in right hand, especially in mornings. Much worse if I sleep on side.  1/28/21: Saw Chiropractor, thinking I had pinched nerve in neck (previous MRI showed disk bulges at C5-6 and C6-C7). Numbness and symptoms continue. Heat or ice no help.  Must sleep flat on back with no pillow to prevent numbness/tingling.  2/27: 2nd Moderna vaccine, little swelling.   Stiffness in neck/shoulder continues.  Numbness and tingling start in left hand as well as right.  3/10/21: Saw Dr. (Orthopedic Surgeon), prescribed Gabapentin and PT. Gabapentin no help,  PT including traction to stretch neck,  and new exercises temporarily help with neck stiffness and numbness and tingling, but symptoms return.  3/27 Hands (BOTH) and fingers extremely stiff and bent in morning, painful and difficult to flex. Never had arthritis in hands previously. 4/7/21: televisit with (PCP), recommended RA test (negative) and prescribed Tizanidine (helps me get to sleep). Recommended follow up with neurologist (MS). March-July: arthritis symptoms in hands every norming, numbness and tingling in fingers almost continuous. Noticable increased pain in knees when squatting.  4/24: some numbness and tingling in butt and feet when laying down flat.  4/28/21: Saw my neurologist (Dr.) out of concern that these were new MS symptoms. ( I had stopped taking Betaseron in December 2020). Recommended MRI of head and neck, which showed no new lesions indicative of MS exacerbation. Prescribed dose pack of Prednisolone which helped relieve stiffness and pain in neck and shoulders (it returns later, but not as bad). Recommended EMG.  6/18/21: Saw Milvia Yadira Pleitez, for EMG which indicated bilateral carpal tunnel syndrome.  6/22/21 Saw Dr.  EMG shows sensory and auto nerves affected on R hand, sensory only on left hand. Wear wrist braces for 12 weeks, then steroid shots if necessary, then surgery.  Knee xray shows no abnormalities.  Physical therapy for knee available.  Arthritis in hands/knee may be related to COVID vaccine.  6/22-7/10: Taking Naproxen about every other night, muscle relaxant only when stiff.  Neck and shoulder better but still stiff. Can sleep on side for limited time.  Fingers still numb, no improvement with hand braces.  Hand pain and stiffness in a.m. Knee pain when squatting continues.
has Covid-19; has Covid-19; This is a spontaneous report from a non-contactable consumer (patient) via company representative. This consumer (patient) reported for self.  A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single for COVID-19 immunisation; also received dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in 2021, the patient experienced has Covid-19. Person had the Pfizer Covid-19 vaccine series in Apr2021 and now has Covid-19. Event took place after use of product. Outcome of the event Covid-19 was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
11-11-09 developed numbness, sand paper/needles in bottom of right foot traveled in calf/knee during night. 11-12-09 developed symptoms, prickly, numb, needles in left foot/leg up to just below knee. 11-13-09 sensations moved up to hip, later in day appt. with neurology dept. doctor. History of MS, seen by doctor of last 4 years. Dr suspects MS exerbation. MRI scheduled 11-27-09 check spinal. 11/24/09 Medical records received for date 11/22/09. DX: MS relapse. Pt presents w/ c/o LE leg pain/numbness. Pt states sx began x10 days ago after H1N1 vax. Sx. bagan in rt. foot, then both legs and presents now w/ pain/weakness/ numbness at hip level. Pain in legs even w/ light touch. Pt states clothing is painful. Coordination off. (+)constipation. Assessment: c/o trouble hearing, sinus problems, difficulty urinating, urgency, sexual problems, neck pain, dizziness. Motor assessment: tone increased in LE, decreased light touch and pinprick in LE, vibration absent in LE, not able to walk on toes/heels.
Patient passed out about 5 minutes after vaccine, did not respond to stimulus, 911 called, pt woke up after about 10 seconds, blood pressure 110/58. Pt was awake for about 5 minutes then pass out again, this time was longer with no response to stimulus, patient was moved to the floor from a chair where he woke back up. EMS arrived and monitored patient.
Child had fever 104 x 24 hours then followed by a rash about 48 hours later.
This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tested positive for Covid-19) in a 48-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 013B22A) for COVID-19 prophylaxis. No Medical History information was reported. On 05-Aug-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 19-Aug-2022, the patient experienced COVID-19 (tested positive for Covid-19). At the time of the report, COVID-19 (tested positive for Covid-19) outcome was unknown.    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Aug-2022, SARS-CoV-2 test: (Positive) Positive. The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown. No concomitant medication information provided. It was reported that patient did not had any allergies. Patient did not had any Acute and Chronic illnesses at the time of vaccination. Patient did not had other vaccines within 1 month prior to Moderna COVID-19 vaccine. Reporter stated that at her work they asked her to get tested for Covid-19 every week. She had never tested positive before. She would like to know if the vaccine could compromise the result of the test, and if she should keep on getting tested now that she received the vaccine. Patient did not experienced any similar event in the past. No treatment information provided. Company Comment:  This spontaneous case was reported by a patient concerning a 48 year old female patient with no medical history reported , who experienced non-serious , unexpected , of Covid 19 which occurred 14 days post vaccination with the dose 1 of mRNA-1273 vaccine.  This patient tested positive for SARS COV 2 test last 19-08-2022.   Reporter stated that at her work they asked her to get tested for Covid-19 every week. She had never tested positive before. Treatment information  results of other laboratories/diagnostic procedures were not  reported. There was no information if this patient made any  medical consultation. Outcome of the event  is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report. Sender's Comments: This spontaneous case was reported by a patient concerning a 48 year old female patient with no medical history reported , who experienced non-serious , unexpected ,of Covid 19 which occurred 14 days post vaccination with the dose 1 of mRNA-1273 vaccine.  This patient tested positive for SARS COV 2 test last 19-08-2022.   Reporter stated that at her work they asked her to get tested for Covid-19 every week. She had never tested positive before. Treatment information  results of other laboratories/diagnostic procedures were not  reported. There was no information if this patient made any  medical consultation. Outcome of the event  is unknown. The benefit -risk relationship of mRNA -1273 ( Moderna Covid 19 Vaccine) is not affected by this report.
8 days post vaccine, red sharply demarcated rash over vaccine site, with pruritis. Resolved in about 1 day with topical steroid cream.
Dizziness, NauseaVomiting, dizziness, light headedness, nauseas and weakness Narrative:
Redness, pain, warmth on day 2 after injection left deltoid. Pt referred for assessment with PCP.
Left leg from knee down became numb and calf tight feeling a few hours after shot. On 8/9/2021, both legs and hands were numb and increased heart rate. Went to family practice/after hours clinic. Was treated for neuropathy with anti inflammatory and steroid pack. On 8/17/2021, still having numbness and lightheaded. Was seen again at same clinic. Ended up having high blood pressure. Now on blood pressure medication (metoprolol)
The night he got the injection the patient states he felt very hot and ill. He did not have a fever, and by the next morning he felt fine. He states his left arm was very sore for 3 days, but not red or swollen, and at this time he has no pain or discomfort.
patient stated she felt faint and was going to go "out". Patient went unconscious continued to breath, flushed on arms and chest ems called patient awoke EMT arrived and spoke with patient taking blood pressure and oxygen level. Patient stated she did not want to go to hospital and EMTs escorted her to her car and she was driven home
Rash on right side; Some swelling; Itching right arm, right buttock and right calf; Skin pain right arm, right buttock and right calf; Felt like there were bugs crawling around patient; Tingling all over body with pain around body; This is a spontaneous report from a contactable consumer, the patient. A 62-year-old non-pregnant female patient received unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in left arm on 12Mar2021 at 10:30 (at an age of 62-year-old) as single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was allergic to bug bites. She had no allergies that she knew of except when she got bitten by a mosquito, she swelled up also bug bites. She had a reaction to them, spiders, fleas ext. There was no other medical history. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included Calcium (MANUFACTURER UNKNOWN), vitamin D (MANUFACTURER UNKNOWN) and vitamin B12 (MANUFACTURER UNKNOWN) for an unknown indication and from an unknown start date and unknown if ongoing. On 12Mar2021 at 18:00, the patient experienced rash on right side, some swelling, itching and skin pain, right arm, right buttock and right calf, she felt like there were bugs crawling around, tingling all over the body with some pain/tingling around her body. The therapeutic measure was taken for event as benadryl. Events lead to doctor or other healthcare professional office/clinic visit. The clinical outcome of all events was resolved on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
patients received an Adacel vaccine which had been frozen and thawed/ no AE; Upon internal review and information received on 07-Aug-2019, significant amendment was performed on 16-Aug-2019 to amend case from non-valid to valid.  Initial information received on 07-Aug-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case is linked to cases 2019SA196353, 2019SA224138, 2019SA224143, 2019SA224139, 2019SA224144, 2019SA224140, 2019SA224141, 2019SA224142 and 2019SA224145 (same reporter).  This case involves a patient who was administered with the dose of 0.5 ml DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (Lot C55608AA, Expiration Date: 25-Jan-2021, Lot C5585AA, Expiration Date: 10-Mar-2021, via intramuscular route and site of administration not reported) which had been frozen and thawed between period of 26-Mar-2019 to 24-Jun-2019.   It was also reported that there had been multiple excursions over the course of a few months.  It was case of an actual medication error due to incorrect product storage.  Case details: Caller stares that her facility was using the Adacel vaccine and she was going through the fridge log and realized that she was not being informed when the vaccines were out of the 2 to 8 C range. Caller states that there are 2 situations. Caller states that she looked at July and the vaccines dropped to 1.4 C and 1.5 C.Caller states she consulted with a scientist and was told that their thermometer was not the appropriate one for the vaccines and that it was only monitoring the air temperature and not the vaccines. Caller states that the same vaccines have gotten down to -4 C a month before this current excursion occurred.  No adverse event 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.  Addendum 16-Aug-2019: Significant amendment was done to amend case from non-valid to valid.  List of documents held by sender: none.
Paralytic stroke like symptoms - required Intensive Care with airway intubation. Neurologist questioning if this is related to the flu vaccine.
Fever of 102.1, throwing up twice. Fever lasted for 3 days ranged from 102 to 104. Rash all over body and forehead. Tylenol and Advil every 4 hours while fever was present.
swelling on the forearm; administering it to a 93 year old patient intradermally; Initial information received on 15-Jun-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 93 years old female patient who had swelling on the forearm and administering it to a 93 year old patient intradermally after receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 14-Jun-2023, the patient received a dose 1 0.5 ml once of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection, (unknown strength, expiration date), lot U7671AA via intradermal route in the left arm for immunisation.  On 14-JUN-2023 the patient developed a non-serious swelling on the forearm (peripheral swelling) and administering it to a 93 year old patient intradermally (incorrect route of product administration) (latency: same day).  Lab data was not reported.  Action taken was not applicable.  The patient was treated with FLUOCINONIDE (FLUOCINONIDE) for Peripheral swelling.  Outcome: Unknown for all the events  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 the guidelines. 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.
her left arm where the vaccine was administered got very bruised after the 1st dose; This is a spontaneous report from a Pfizer- sponsored program from a contactable consumer (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 05Apr2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the 1st dose on 05Apr2021 and her left arm where the vaccine was administered got very bruised after the 1st dose. Patient called in to reschedule her 2nd dose appointment which was scheduled on 19Apr2021. She said she's unable to make it because she had another appointment on that day. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Patient presented to Medical center with right sided MCA stroke (proximal M1) occlusion.  She underwent tPA therapy and is recovering. She has a history of breast cancer that was treated in 2017. It?s unclear to us whether or not these events are related. However, given the thrombosis occurred on the same day as the vaccine was administered, we felt it was a reportable event
site of inj red, swollen, warm to touch, baby crying all the time; temp? APAP given;
I was traveling out of state and returned on 10/17/2022. That night I ended up in the hospital with fluid on my heart. I was admitted in the hospital for 3 days. I am diabetic and have been on a very low salt diet, but while traveling, I was unable to abide by that diet. While in the hospital they treated me with LAsix and insulin and informed me that they thought my issue was due to my poor diet and lack of activity while traveling. They didn't test me for COVID-19 in the hospital. On Friday, I was informed that a friend tested positive for COVID-19. So, I tested myself and was also positive. I tested again on Sunday and was still positive. I had a little bit of stuffiness on Friday and had a bit of an irritated cough but no fever or loss of appetite or senses. By Sunday, when I woke up, even those symptoms were gone. Now, I am only experiencing an occasional cough, but even that is almost nonexistent. Everything was so mild; it didn't even feel like a cold.
New onset peripheral neuropathy evening after shot, felt like a deep burn that started mid shin to toes, not radiculopathy. Constant for 3 days, worse in the evenings. Associated with mild frontal bilateral HA and a few occurrences of fleeting fasciculation of R lip and R paraspinal muscles. Symptoms complete resolved after 1 week.
Chills, fever, lightheaded, sore arm, tender under arm/left breast area
I woke up the next morning with a Headache and sick feeling. This was about 19hours after the shot. My arm was really sore and pain going back into the shoulder area. This was about 7 hours after the shot and into the next morning.
Had flu shot on Tuesday 9/15/09. Swelling and pain began 9/16 and lasted until 9/24/09. ADVIL first Wednesday AM took 9/16 ROBAXIN the night before. Swelling improved with ADVIL resolved after 8 days. Fibromyalgia x 15 years.