chrisvoncsefalvay/vaers-outcomes huggingface dataset:
muscle and joint pain; muscle and joint pain; hot flashes; headaches; stomach pain; diarrhea; This is a spontaneous report from a Pfizer sponsored program COVAX US Support from a contactable consumer. A Patient of unspecified age and gender received Covid-19 Vaccine (BNT162B2) (Batch/Lot number: Unknown, Expiration date: Unknown, Solution for injection) via an unspecified route of administration on 18Feb2021 as Dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. On an unknown date patient experienced side effects like muscle and joint pain, hot flashes, headaches, stomach pain and diarrhea. No therapeutic treatments were received. The outcome of the events were reported as unknown.  Information on lot/ batch number has been requested.
4/2: Resting heart rate went to 181 bpm. Went to emergency room, had blood work and ekg done. Sent home. 4/4: Resting heart rate went to 160 bpm. Went to emergency room, had blood work done and ekg done. Referred to take Benadryl.  Sent home. 4/6: Saw primary care provider. Discussed adverse events post vaccine. Prescribed propranoloL. 4/7: Resting heart rate 186 bpm. Transported to hospital by ambulance. Blood work and ekg done. Prescribed diltiazem. Referred to cardiologist. Sent home.
being  pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (being  pregnant) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 27C20A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (6 cups/weel) on 17-Oct-2020. Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Multiple allergies.    On 09-Jan-2021 at 2:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-Sep-2020 and the estimated date of delivery was 28-Jun-2021. On 09-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (being  pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  fifteenth week of the pregnancy.  On 09-Jan-2021, EXPOSURE DURING PREGNANCY (being  pregnant) had resolved. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Nov-2020, Gene mutation identification test: unknown.     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.   Company comment:This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 33-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.
This initial spontaneous case, was received from nurse on 09-Nov-2017, concerns a 51-year-old adult female patient. The patient's medical history included low thyroid, anxiety, depression and concomitant medications included SYNTHROID, vitamins and KLONOPIN for an unknown indication. On 01-Nov-2017, the patient was administered with AFLURIA QUADRIVALENT (dose: 0.5 ml, route of administration: intramuscular, anatomical location: left deltoid, batch no: XF31407 and expiry date: 30-Jun-2018), which underwent at least one temperature excursion and there was no event occurred after administration of vaccine. It was reported that, vaccine reached to 34.29-degree F and returned to recommended storage range (36-46 degree F, as reported) and vaccine did not freeze. The reporter assessed the case as non-serious. Follow up report received on 30-Nov-2017: The concomitant medication (KLONOPIN) was updated. The narrative was amended accordingly.
Pfizer-BioNTech COVID-19 Vaccine EUA. Pain on injection site 2/12/2021 around 9:30pm Chills 2/12/2021 around 9:45pm still on and off 2/13/2021 it is 10:35am Mild Headache around 9:45pm Body aches 2/13/2021 still at 10:35am Tingling on feet for several minutes 2/13/2021  around 8:30am Tingling on left hand 2/13/2021 around 8:30am Fever (102) 2/13/2021 noticed when wake up at 7am feeling better now at 10:39am temperature now is 98.8. A very mild chest pain on left side it was sharp last for 10 minutes 2/13/2021 around 10am Back pain on base of left lung for around 1 hour 2/13/2021 8:30am Tiredness 2/12/2021 around 8:30pm, still happening at 10:42am on 2/13/2021
Infant cried immediately after the vaccine injections and turned red. Mom states seconds later his face turned pale / "almost blue". I checked him and his pulse was 140, pulse ox 94, BP 82/42 and his color was pink. He was observed for 30 min and was normal. 4 hrs later infant is fine.
hives in her chest and neck; Her neck and chest were itchy; had a headache and was tired; had a headache and was tired; This is a spontaneous report from a contactable Other HCP reporting for herself.  A 50-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685), via an unspecified route of administration in the right arm on 23Dec2020 12:00 at single dose for COVID-19 immunisation. Medical history included seasonal allergies to: Ragweed, bees, mold, trees, lots of seasonal things. The patient's concomitant medications were none. On 23Dec2020 the patient had a headache and was tired with outcome of unknown, the patient attributed it to having a stressful day. On 24Dec2020 (between 00:00 and 06:00), she had hives across her neck and part of chest. Her neck and chest were itchy and she had hives the next morning. The patient took diphenhydramine hydrochloride (BENADRYL) for 2 days for hives and was all better. She would like to know if she should get the second dose.
Vaccine administered 10/19/06 at 1pm. Rash noticed next morning 10/20/06 7am across upper chest and throat. Rash spread to back, shoulders, neck by 10/21/06. mild itch.
Wide range of fluctuations in oxygen; This spontaneous case was reported by a patient family member or friend and describes the occurrence of OXYGEN SATURATION ABNORMAL (Wide range of fluctuations in oxygen) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination.     Concurrent medical conditions included COPD.    On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced OXYGEN SATURATION ABNORMAL (Wide range of fluctuations in oxygen). At the time of the report, OXYGEN SATURATION ABNORMAL (Wide range of fluctuations in oxygen) had not resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication details was reported. No treatment medication details was reported.
DEATH; This spontaneous report received from a consumer via social media via a company representative concerned a patient of unspecified age, sex, race and ethnicity.. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. On an unspecified date, the patient was previously received covid-19 vaccine ad26. cov2. s (dose number in series 1) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total, administered for prophylactic vaccination. It was unknown whether patient had any adverse events (dose number in series was 1).  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series was 2) (suspension for injection, route of admin, batch number and expiry were not reported) dose, start therapy date were not reported 1 total, administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient died from unknown cause of death (dose number in series 2). As per reporter, "When I lost my best friend of 6 years die after the booster." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death). This case, from the same reporter is linked to 20220246041.; Sender's Comments: V0: 20220246293-COVID-19 VACCINE AD26.COV2.S-death. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Patient developed thrombocytopenia on 1/5/21 and was seen in my office on 1/6/21 with platelet count of 2,000 and referred to heme. Because platelets remained low - she received IVIG and gradually platelet count recovered
Dizziness, vasovagal response. BPs 86/48 (pulse 74), 108/67 (pulse 88). O2 sat 100%. Hydration and rest.
Node in back of arm; Arm still hurt; Nausea; Received a sub-cutaneous injection; Felt like she had a ball in her throat; Thought she was going to pass away; Dizziness; Weakness; A spontaneous report was received from a nurse, concerning herself, a 60 year-old female patient, who received Moderna's COVID-19 vaccine and experienced dizziness, weakness, nausea, felt like she had a ball in her throat, arm still hurt, node in the back of arm and received a subcutaneous injection.  No relevant medical history was provided. Concomitant medications reported included metoprolol, omeprazole, and melatonin.  On 15-Jan-2021, prior to the onset of events, the patient received the first of two planned doses of mRNA-1273 (lot number 011J20A) subcutaneously in her left arm for COVID-19 infection prophylaxis.  On 15-Jan-202, patient received her first dose of the vaccine at background of left arm. On the same date, after administration of vaccine, she stayed in place for 25 minutes/1hour as she experienced dizziness, weakness and nausea, she also felt like she had a ball in her throat and thought that she was going to pass away. Few minutes later, patient was feeling little better but then started again, hence stayed back for an hour in the same place. On 19-Jan-2021 (today) her arm was still hurt pretty much and had a node in her back arm. Patient also stated that vaccine was not administered in her muscle instead injection was provided sub-cutaneous.   Action taken with mRNA-1273 in response to the events were not reported.  The outcome of the event, received a sub-cutaneous injection, was considered to be resolved on 15 Jan 2021.The outcome of the events dizziness, weakness, nausea, felt like she had a ball in her throat, was considered to be unknown. The outcome of the events arm still hurt, and node in the back of arm was considered to be not resolved.; Reporter's Comments: This case concerns a 60-year-old, female patient. The patient's medical history was not provided. The patient experienced a non serious event of dizziness, malaise, nausea, asthenia, lump in throat, subcutaneous injection, pain and swelling in arm. The event occurred the day the patient received the first dose of mRNA-1273 (lot number 011J20A). Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
pale, warm & clammy, diaphoretic, shakey, nauseated w/in 4-6 mins p/vax; pt given DPh & observed x  1 3/4 hrs;
cried for >3hrs immed p/vax w/low grade temp, slept ok that noc, was fine the next day;
IPOL being administered post excursion, with no reported adverse event; Initial information regarding an unsolicited valid non-serious case received via nurse on 04-Oct-2022. Agency number: 01306733  This case is linked to cases 2022SA409671, 2022SA412043, 2022SA412040 and 2022SA411401 (CLUSTER).  This case involves a 14 years old female patient to whom IPV (VERO) [IPOL] being administered post excursion, with no reported adverse event.   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On 27-Sep-2022, the patient received 6th dose of suspect IPOL vaccine being administered post excursion at dose 0.5 ml once via intramuscular route in the left deltoid (lot: U1C571M, expiry: 17-Jun-2023) for prophylactic vaccination with no adverse event (poor quality product administered) (latency same day).  Action taken: Not applicable.  At time of reporting, the outcome was unknown.  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 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.
develop a serious infection in my right breast and side; Because the vaccine creates inflammation which mimics breast cancer, is it possible that the vaccine was a catalyst for the infection; This is a spontaneous report from a contactable consumer (patient).  A 53-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6207), via an unspecified route of administration in left arm on 19Mar2021 at 08:30 as a single dose for COVID-19 immunization. Patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EN6200), via an unspecified route of administration in left arm on 24Feb021at 08:30 as a single dose for COVID-19 immunization. The patient's medical history included Allergies to medications, food, or other products: Sulfa, erythromycin, Breast cancer surviver, Lymphedema on the right side due to radiation treatment. The patient's concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient's 2 weeks prior medication included Lisinopril, Tamoxifen, Vitamin supplements. Prior to vaccination, patient was not diagnosed with COVID-19. COVID prior vaccination was none. On 20Mar2021 at 11:00 pm, the night after the injection, she developed a serious infection in her right breast side. The patient stated that as vaccine creates inflammation which mimics breast cancer, the patient wanted to know whether it was possible that the vaccine was a catalyst for the infection. The patient was treated with antibiotics for the events. The outcome of the events was not resolved.  Follow-up (24Mar2021): Follow up was received from the same contactable consumer(patient) in response to trail mail sent included: medical inquiry. No follow-up attempts are needed. No further information is expected.
a few minutes after the injection the patient exhibited signs of a syncope reaction. but not typical. after about 10 minutes she appeared to be having difficulty breathing and tongue appeared  to be swelling. called 911 and administered an EpiPen. ems arrived. she had stabilized somewhat. they transported her to hospital.
After my second dose, I noticed I had a single swollen lymph node in my clavical region on the side I got the vaccine. I had the same reaction after the first dose, which hadn't fully gone away by the time I received the second one. It swelled up again a few hours after receiving the second dose.
Narrative: Admission Date: Aug 28,2021 Discharge Date: Aug 31,2021 Condition of patient at discharge: Stable Primary Diagnosis during Admission/Treatment: Acute on Chronic Hypoxic Respiratory Failure, COVID pneumonia 71 yo M w a past medical history of HIV (inconsistent HAART use), latent TB previously treated, pulmonary embolism not on anticoagulation, prostate cancer, pHTN, T2DM, EtOH abuse, and COPD with severe emphysema on CT, on 2L home O2 presenting with SOB. He was recently seen in the ED on 8/23/21 with complaints of abdominal pain and COPD exacerbation. At the time he was found to have new alveolar and interstitial infiltrates in the LLL and RLL c/f multifocal pneumonia. He was prescribed Augmentin suspension, but admits he only took 2 doses of it since discharge. He also admits that he does not take most of his medications due to difficulty swallowing. He was not COVID tested at the time. He was diagnosed with COVID in 11/2020. He also received both doses of Pfizer vaccine on 2/2/21 and 2/23/21. On presentation to the ED he was afebrile. He had increased oxygen demand and required 3L NC (vs home O2 of 2L NC). He had no significant lab abnormalities. He was COVID positive and admitted for recurring COVID pneumonia in the setting of atypical pneumonia and COPD. His hospital course was uneventful and he was discharged in stable condition 3 days later.
Exactly 12 hours after vaccination I had the following reactions at 3:00am the following morning:  Fever in excess of 102.5, muscle spasms, jaw clamped tight, extreme chills, shortness of breath, could not breathe lying down (felt like diaphragm was suppressed), and broken blood vessels in right eye.  Had to sleep sitting up for fear of not being able to breathe.  Lasted a couple hours.  Now I just have a lingering low grade fever.
Patient experienced syncopy (faintness) after 5 minutes of getting the vaccine and was unconscious for roughly 1 minute. No other symptoms.
Chills 2 hours Fever 4 hours Headache 36 hours Nausea 36 hours Injection site swelling 36 hours Injection site pain 36 hours Body aches 12 hours Coughing 24 hours
developed a staph infection same location of body and worse on backside and face; tired; headache; This spontaneous case was reported by a consumer and describes the occurrence of STAPHYLOCOCCAL INFECTION (developed a staph infection same location of body and worse on backside and face) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011D21A and 054C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced STAPHYLOCOCCAL INFECTION (developed a staph infection same location of body and worse on backside and face) (seriousness criterion medically significant), FATIGUE (tired) and HEADACHE (headache). The patient was treated with CEFAZOLIN for Staphylococcal infection, at an unspecified dose and frequency and DOXYCYCLINE for Staphylococcal infection, at an unspecified dose and frequency. At the time of the report, STAPHYLOCOCCAL INFECTION (developed a staph infection same location of body and worse on backside and face), FATIGUE (tired) and HEADACHE (headache) outcome was unknown.            Concomitant medication information included "prescribed medications" that were not specified.   Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   This case was linked to MOD-2021-265793 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Pain in left arm where shot was given, into my shoulder between shoulder blades into the armpit on the right side, was unable to sleep, or lift my left arm. Started to subside in 24 hours.
This spontaneous report as received from a nurse refers to a 13 year old male patient. Nurse reported two patients (brothers) received first dose of VAQTA 25/0.5 intramuscular on 06-FEB-2013 and the second dose of VAQTA 25/0.5 (lot# unknown) intramuscular five months after the first dose on 02-JUL-2013. No co-suspected medicine reported. No concomitant medication reported. No adverse effect reported. The outcome was unknown. Action taken not provided. This is one of several reports from the same source. Additional information has been requested.
Fever Vomiting diarrhea unable to sit/stand up incontinence Wife called an ambulance and patient ended up in ER and spent 3 days in hospital.
High heart rate while at rest, over 100 beats per minute with palpitations; High heart rate while at rest, over 100 beats per minute with palpitations; shortness for breath.; This is a spontaneous report from a contactable consumer (Patient). A 36-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, Lot number: unknown, Expiration date: unknown), dose 2 via an unspecified route of administration in arm left on 14Apr2021 at 10:30 (age at vaccination was 36 years) as single dose for COVID-19 immunization. The patient's medical history included COVID-19 from an unknown date. The patient did not have any known allergies. Concomitant medication included loratadine, pseudoephedrine sulfate (CLARITIN D 12 HOUR) in two weeks. The facility where the most recent COVID-19 vaccine was administered was unknown county. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 15Apr2021 at 11:00, after first dose the patient experienced high heart rate while at rest, over 100 beats per minute with palpitations and shortness for breath. No treatment was received for the adverse events. The patient underwent lab tests and procedures which included heart rate: high/over 100 beats per minute on 15Apr2021. Patient visits healthcare professional office/clinic visit, Emergency room/department or urgent care. No treatment received for the adverse events. The outcome of the events was resolving.   Information about Lot/Batch number is requested.  Follow-up (17Sep2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.
Stiff/unable to walk/move, freezing, stabbing feeling in stomach, loss of appetite.
Information has been received from a registered nurse concerning a patient who on 17-NOV-2009 was inadvertently vaccinated with a standard dose of VARIVAX (Merck) (lot#, route and site of administration not reported) instead of ZOSTAVAX (Merck) which was administered by another nurse. No apparent adverse event was reported. Additional information has been requested.
Chest tightness and muscle "twitches" within 15 minutes of receiving 1st does of Moderna COVID-19 vaccine. Evaluated by onsite EMS:  12 lead EKG and vital signs (BP 151/95, HR 88, Resp 20, Pulse ox 96%, normal sinus rhythm). Declined transport via ambulance to hospital. Instructed to follow up with PCP and seek care if chest pressure returned.
Pt. stated that she started feeling itchiness, pain, redness and swelling at the injection site the day after the administration.