chrisvoncsefalvay/vaers-outcomes huggingface dataset:
I had blood in my urine in December 2022. I made an appointment with my doctor; he ordered bloodwork and CT scan with contrast. I was referred to a Urologist, that I was to see in January 2023. I started having pain a week before the appointment I had terrible pain that caused me to go into the emergency room. I had been vomiting, they looked over my chart saw that I had the kidney stones, and I was presenting for pain of the kidney stones. I was given pain medication, antinausea medication sent home. Once I got into the doctor's appointment, we discussed that the kidney stone had moved, and it should pass. After a while it I started having pain again, I made another appointment, I had x-rays where we discovered the stone was stuck in the ureter, the decision was made to remove the stone.
Patient had arm swelling, heat, redness, and pain in the arm the shot was given in, Reaction was described as being in the lower outer portion of the arm nearer the elbow (not near the injection site).
Red rash on chest/brest area with slight tightness to right breast (same rash after 2nd dose of Moderna in Feb 2021)
No adverse affects reported.; HCP calling to report that PROQUAD was administered after undergoing a TE. No adverse affects reported. Caller stated this occurred in February 2023.          ?    Names of vaccines involved (including lot/exp): PROQUAD (Lot: W019631, Expiration: 1; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   In February 2023, the patient was administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) (0.5 ml, lot #W019631, expiration date: 19-DEC-2023, strength and route of administration were not provided) for prophylaxis after undergoing a temperature excursion (TE) (Incorrect product storage).  Administered measles, mumps, rubella and varicella (oka-merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) was stored at 13.5 degrees Fahrenheit (F) for 3 hours, 5 minutes, 0 seconds. There was no previous temperature excursion reported. No adverse affects reported.
Headache; Nausea; Anorexia; Chills Sweats; Nosebleeds X2
Narrative: 72 yo M died at home in home hospice of Malignant neoplasm of colon - stage 4 3. Secondary malignant neoplasm of peritoneum. Pt received vaccines on 2/26/21 at facility & on 3/21/21 at other site unknown. Pt's death not related to covid vaccines.
Per pts. mother, pt. started experiencing extreme fatigue/weakness and some nausea in morning on 08/21/2009. Pt. was taken to PCP and Hgb check was done as pt. also started menses on 08/21/2009. Pt. felt fine all weekend and then on 8/25/09 started with headache, chills, nausea, and weakness, and was again taken to PCP and was at this time tested for influenza. Per mom, PCP is unsure of course of symptoms.
12/24/22 presents to EC ED for "fever". PMHx of "right renal transplant 6 months ago, thyroid cancer s/p resection, hypertension, hyperlipidemia, sleep apnea and neuropathy"
3rd dose: 14Aug2021; My arm was sore after third dose; My arm was sore; general achiness; flu-like symptoms; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (My arm was sore), PAIN (general achiness), INFLUENZA LIKE ILLNESS (flu-like symptoms), IMMUNISATION (3rd dose: 14Aug2021) and PAIN IN EXTREMITY (My arm was sore after third dose) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced PAIN IN EXTREMITY (My arm was sore), PAIN (general achiness) and INFLUENZA LIKE ILLNESS (flu-like symptoms). On 14-Aug-2021, the patient experienced IMMUNISATION (3rd dose: 14Aug2021) and PAIN IN EXTREMITY (My arm was sore after third dose). At the time of the report, PAIN IN EXTREMITY (My arm was sore), PAIN (general achiness), INFLUENZA LIKE ILLNESS (flu-like symptoms), IMMUNISATION (3rd dose: 14Aug2021) and PAIN IN EXTREMITY (My arm was sore after third dose) outcome was unknown.            11 Feb 2021: Patient received 2nd dose of the Moderna Covid-19 vaccine. Reported that her arm was sore, had general achiness, & had flu-like symptoms. Said she did not had a fever, though. 3rd dose: 14  Aug 2021.  No concomitant and treatment drugs were provided.   This case was linked to MOD-2021-287560 (Patient Link).
No treatment needed yet. Headache, sore throat, dizzy, fatigue temp 99.4, bilateral arms and feet painful pins and needle sensation.
Fever 72 hours; Muscle aches; Chills; Vomiting; This is a spontaneous report from a contactable consumer, the patient. A 16-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09May2021 at 09:00 (at the age of 16-year-old) as a single dose for COVID-19 immunisation. Medical history included autism and attention deficit hyperactivity disorder (ADHD). The patient did not have any allergies to food, medications, or other products. Concomitant medication included  dexmethylphenidate (MANUFACTURER UNKNOWN) from an unknown date, for unknown indication. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 09May2021 at 23:00, the patient experienced fever 72 hours, muscle aches, chills and vomiting. The events resulted in doctor or other healthcare professional office/clinic visit. On 12May2021, the patient underwent nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the event fever was recovered on 12May2021. The clinical outcome of the events muscle aches, chills and vomiting were recovered on an unknown date in May2021.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Low grade fever up to 100.3 degree Fahrenheit Sunday evening (the day after the injection), muscular aches from day of injection, headache the day following the injection, itchy rash on right thigh starting Monday morning (two days after the injection).  Fever reduced to 99 degrees Fahrenheit within two hours following 2 Motrin.
Chest pain.  Hospitalized with Pericarditis on 4/11/23 thru 4/19/23.
Pt developed a rash, resembling chicken pox, on both arms and both legs, starting the night after she received the vaccines.  Still evident 5 days later.  Not getting worse now, since had bath, benadryl, hydrocortisone cream, and calamine lotion.  Very itchy.  Hard bumps, now some with scabs.
This spontaneous report as received from an unknown reporter refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored M-M-R II (lot# reported as H014649, Exp date 08-MAR-2014). At the time of report, the status of patient was unknown. Additional information is not expected.
My entire world has unraveled since getting this shot.  Been to 4 ERs for systemic inflammation and neurological symptoms.  Written off a psycho and about to be committed, but was brilliant.  I believe I was given an undiluted dose of Pfizer without diluent, and became psychotic, and furthermore I believe my parents, who also got it, have had their judgement affected as well.  They have been a lot less urgent with concern for their welfare of me since the shot. All they do is sleep all the time, wouldn't take me to the ER even when I was having trouble reading and staggering around.  I understand I have no credibility here, but please look into this matter seriously, and not just the ravings of a crazy person.
missed second dose /it is now49 days since patient received the 1st dose; Pain at injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second dose /it is now49 days since patient received the 1st dose) and VACCINATION SITE PAIN (Pain at injection site) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Blood pressure. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), MONTELUKAST, ALBUTEROL [SALBUTAMOL] and SALBUTAMOL SULFATE (VENTOLIN HFA) for Asthma, AMLODIPINE and LISINOPRIL for Blood pressure, ASPIRIN [ACETYLSALICYLIC ACID] and VIT D [VITAMIN D NOS] for an unknown indication.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second dose /it is now49 days since patient received the 1st dose) and VACCINATION SITE PAIN (Pain at injection site). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed second dose /it is now49 days since patient received the 1st dose) and VACCINATION SITE PAIN (Pain at injection site) 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 medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Event added.
fatigue; warming feeling; sore arm; joints sore; This is a spontaneous report from a contactable healthcare professional (patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: el3248 and expiry date: unknown), via an unspecified route of administration on the left arm, on 02Feb2021 11:00 at a single dose for COVID-19 immunization. The first dose was received on 12Jan2021 11:00 on the right arm (lot number: ej1656). Medical history included cancer. Patient was not pregnant at the time of vaccination. Concomitant medication included levothyroxine sodium (SYNTHROID) and no other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced fatigue, warming feeling, sore arm, joints sore on 02Feb2021 15:00. No treatment was received for the events. Outcome of the events was not recovered. Patient was not diagnosed with COVID-19 prior to vaccination and has been tested post-vaccination. Covid test was on 03Feb2021 with unknown results. The reporter considered the events non-serious.
10 minutes after receiving the vaccine, the patient noticed he was developing red dots all over his body. They were not itchy, and they looked like petechiae.
High fever (to 103.6), cough, fussiness, decreased appetite.  Symptomatic treatment.
A few hours after the vaccine I had a hive on my chest and my jaw was sore.  Next morning it was gone but I had body aches.
Within one hour: headache, some joint pain Within 7-8 hours: severe joint pain and muscle aches (about 9-10 on scale), fever, chills, vomiting Body pain lasted for 12 hours, next morning pain was lessened but still present , about 5/6 on a 10 scale
Patient received a 2nd dose of Moderna only 22 days after the 1st dose. 1st dose on 6/1/21 and 2nd dose on 6/23/21.
Pt received VZ vaccine #2 0.5ml SC to L arm @ 11:45am, and pt experienced swelling to site immediately. Pt c/o to itching to area. Denies pain, SOB, itching throat, dizziness. Pt appeared with good skin color, stable. Pt is accompanied with mom and siblings. Ice packed applied to area.
Woke up out of sleep and felt very warm, and a tingling sensation which started mid thoracic region which then traveled up to base of my neck and then spread bilaterally to both arms and hands; was brief and then just dissipated
Fever,  body aches, headache, chills, tired, vomited bile, weak, high blood pressure, visual changes.
Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 53-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 16-Sep-2021 at 11:55 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 16-Sep-2021 at 11:55 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 16-Sep-2021 at 11:55 AM, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Treatment information was not provided.
This is a spontaneous case, initially received on 29-Nov-2017, from a consumer, concerning a 31-year-old, adult, female patient. The patient was allergic to penicillin. It was reported that, the patient never had flu reaction in the past. On 22-Nov-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: right arm, batch number: reported as 1720701 or 179601P (reporter didn't know which one pertained to the vaccine that she received), expiry date: 30-Apr-2018). On 24-Nov-2017, after 3 days of vaccination, the patient had severe pain in the arm, hole in her arm and deterioration of a piece of muscle tissue. The patient believed that the reaction occurred as the injection was given at wrong location. The patient used ice packs on the affected area of her arm. It was reported that, the patient received TYLENOL. The patient had scheduled an appointment with the physician. At the time of the report, the patient had completely recovered from the events and reported that the patient did not felt pain anymore and everything was fine to her. The reporter assessed the events as non-serious. Non-significant follow-up received from other non-health professional on 02-Jan-2018: Added lot number (1720701 or 179601P, reporter didn't know which one pertained to the vaccine that she received). The reporter confirmed that the patient received TYLENOL. The narrative was amended accordingly. Follow-up from other non-health professional received on 24-Jan-2018: The other non-health professional confirmed that patient had recovered from the events. Narrative amended accordingly.
Initial information received on 04-Dec-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 5 months old male patient who received and expired dose of  vaccine PENTACEL (batch number: C526AAA, expiry date: 29-Oct-2018) (dose in series not reported) via intramuscular route in the right thigh on 03-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVNAR for Immunization; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunization. It was a case of actual medication error due to Expired vaccine used. No adverse event was experienced. It was  reported that there were no side effects. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders 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. List of documents held by sender: none.
Administered expired vaccine to patient, after the manufacture date of expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine to patient, after the manufacture date of expiration) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date the vial initially stored in the refrigerator was reported as unknown. Vaccine manufacture date of expiry was reported as 09-Nov-2021 with total of 168 doses. The vial did not undergo any temperature excursions.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Live follow up received contains non significant information.
tachycardia, up to the high 150's; carotid body syndrome caused by inflammation in carotid body; The initial case was missing the following minimum criteria: other-Info not qualifying for AE. Upon receipt of follow-up information on (15Sep2022), this case now contains all required information to be considered valid.  This is a spontaneous report received from a contactable reporter(s) (Physician) from medical information team, Program ID.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (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: Covid-19 vaccine (Primary immunization series complete but manufacturer unknown), for COVID-19 Immunization. The following information was reported: TACHYCARDIA (hospitalization), outcome "unknown", described as "tachycardia, up to the high 150's"; INFLAMMATION (hospitalization), outcome "unknown", described as "carotid body syndrome caused by inflammation in carotid body". The patient underwent the following laboratory tests and procedures: Cardiac failure high output: high, notes: cardiac work up; Cardiac stress test: Unknown results; Heart rate: 150s, notes: Increased/tachycardia, up to the high 150's. Additional information: Product: Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent. Dose/Dosage Form: Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than equal 12 years-15/15 mcg per dose. With the initial vaccine this did not happen. With the booster, tachycardia, up to the high 150's, patient had to be hospitalized. Patient had a cardiac work up, stress test. Diagnosed as carotid body syndrome caused by inflammation in carotid body. Patient was on beta blockers for 6 months after the dose. Gave Moderna booster at half dose. Cardiologist recommended to give it again, but it happened again.Reporter inquired whether Carotid body syndrome with tachycardia required beta-blocker treatment after Moderna vaccine, and if there is less chance of tachycardia, heart rates in the 150s with the Pfizer vaccine. 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.; Sender's Comments: Based on the known safety profile and Limited information in the case report a casual association between reported events and the suspect drug cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate
Vaccines given 2/23/09.  Patient monitored 30 minutes post vaccines.  No problems or complaints reported.  Patient returned for visit 2/26/09 & reported rash onset est. 20 hours post vaccinations.  No respiratory complaints.  Rash is resolving.  Pt has not yet contacted PCP.  He agrees to do so today 2/26/09.
Pt states had some dizziness about 1/2 hr after Immunization Then started to have like a lump in throat- "Frog in throat"  Provider ordered IV and NS with 25mg Benadryl PO Pt had no other complaints was transferred to ER per Emergency provider consult
Narrative: Covid+, hospital Emergency room, confusion, weakness, fall-hit head, fatigue, nausea, parkinsons, Moderna#3, returned home
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Mar-2021 at 8:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 31-Mar-2021 at 8:48 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 33.92   Concomitant products were not provided.  On 31-Mar-2021, Excursion time was 08 AM,  temperature was 32 total doses given for the day was 199, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 23-Mar-2021, vial was moved to clinic on 31-Mar-2021. 4 vials were sent to clinic. Vaccine BUD date was 22-Apr-2021.  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported
Supraventricular tachycardia, starting on 12/10/21, requiring two doses of adenosine on 12/11/12, admitted subsequently to the PICU at a local Medical Center, with mildly elevated troponin level, and started on nadolol.
4 days following the first dose (8/13), pt started with mild headache and chest pain that radiated to her back. This pain lasted the entire month, and when she got her second dose on 8/30, she had worsening back pain that radiated down to her right hip and down to her right knee. Pt feels inflamed.
Suspected SIDS. Autopsy also shows hypoxic encephalopathy, subpleural pulmonary hemorrhages