chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient had a syncopal episode immediately after being vaccinated.  Nurse eased patient on to the floor without incident, or injury.  Clinical Staff intervened and obtained vitals.  B/P:108/60, Pulse: 61, O2/Sat :99%.   The episode lasted about 1 minute.  Patient recovered, and was A&Ox3.   He shared that he was stung by a bee as child, and has since experienced fainting spells when he receives injections.
reporting day after the shot, had twitching/shaking in contralateral RIGHT hand this is intermittent and has persisted up to this first report (to my knowledge) ALSO reports developed LEFT side hand twitching, now persistent, the day after getting Moderna #2 lot 002B21A in left deltoid on 3/1921
left upper thoracic transverse myelitis with left leg weakness with improvement after IV solumedrol (still with hemiparesis as of 5/3/22 but improving slowly)
There was an excursion from the freezer; Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. No Medical History information was reported.On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Oct-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 25-Oct-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (There was an excursion from the freezer) and 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. There was an excursion from their freezer on 01-Oct-2021. They used the excursion tool but there was no option for the excursion they experienced. The tool only gives options for excursions above one hour and not less than, so she does not knowhow to do the analysis. She states that her team already knows the recommended temperatures and wants to know if the vials were still okay to be used because they were administered to 118 patients.No concomitant medication was provided. No treatment medication was provided.
The person who gave me the injection said that there was just a drop of blood; I started to see a bruise around the area like a 2 inch bruise like sort of a purplish black and red; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration on 03Feb2021 (not clarified) as a single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. At the time of vaccination, the patient had nothing on where the injection was, and it felt fine. The person who gave the injection said that there was just a drop of blood and was told to put a band aid. Patient saw nothing that evening and yesterday (on an unspecified date in Feb2021) started to see a bruise around the area like a 2 inch bruise like sort of a purplish black and red. This just came over yesterday. Patient enquired that something to worry about, something from the injection, the vaccine. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Armpit has swollen up; Arm is now feeling pain not directly on the injection site. but, it feels like bruising all over arm that was injected in.; Arm is now feeling pain not directly on the injection site. but, it feels like bruising all over arm that was injected in.; This is a spontaneous report from a contactable consumer, the patient. A 30-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the arm right on 09Jun2021 at 12:00(at the age of 30-year-old) as a single dose for COVID-19 immunisation. Medical history included covid-19. The patient did not receive any medication within two weeks of vaccination. The patient had no known allergies to medications, food or other products. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Jun2021 at 16:00 the patient experienced armpit had swollen up and arm was now feeling pain not directly on the injection site. but it feels like bruising all over her arm that she had injected in. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the reported event. The clinical outcome of the events armpit had swollen up and arm was now feeling pain not directly on the injection site, but it felt like bruising all over arm that was injected in were resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness and nervousness immediately after receiving vaccine.  Patient stated that she is feeling better, was given another 15 min additional observation-Voice that she is leaving.  Understanding verbalized.
I started to get up an urine at night more. I had blood in my urine. I had wind up having a bladder stone. My prostate is enlarged.
Hearing loss, Right greater than left after 3rd vaccination. Might also have had a mild myocarditis  after 2nd vaccination
Vaccine administration 1:10 Pm 1:12 not feeling well, 1:16 checked blood sugar 160 1:20 PM vomiting
received 3rd dose covid-19 Vaccine; received 3rd dose covid-19 Vaccine; Rheumatoid arthritis flare up; Sore throat; Asthma; Nasal stuffiness; Stress; Fever; Aches; This is a solicited report from a Non-Interventional Study  based on information received by Pfizer from Company (manufacturer control number: 21K-163-4090390-00.   A contactable consumer (patient) reported that a 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Apr2021 (Batch/Lot number was not reported)(at the age of 57-year-old) as dose 1, single, on 20May2021 (Batch/Lot number was not reported)(at the age of 57-year-old) as dose 2, single and on 20Aug2021 (at the age of 58-year-old)(Batch/Lot number was not reported) as dose 3 (BOOSTER), single; all intramuscularly for COVID-19 immunization and upadacitinib (RINVOQ) orally from an unspecified date (Batch/Lot number was not reported) and ongoing, at unspecified dose for rheumatoid arthritis. Medical history included ongoing rheumatoid arthritis. The patient's concomitant medications were not reported. It was reported that the patient received the 3rd dose of COVID-19 vaccine on 20Aug2021. On an unspecified date in 2021, patient experienced rheumatoid arthritis flare up, sore throat, asthma, nasal stuffiness, stress, fever and aches. Outcome of event rheumatoid arthritis flare up was not recovered while the outcome of all other events was unknown. Action taken in response to the events for upadacitinib was dose not changed.  The reporter's causality assessment for the events Sore throat, Asthma, Nasal stuffiness and the drug RINVOQ(UPADACITINIB) was no reasonable possibility; Rheumatoid arthritis flare up and the drug RINVOQ(UPADACITINIB) was reasonable possibility; Stress and the drug RINVOQ(UPADACITINIB) was not reported. The reporter's causality assessment for the events Sore throat, Asthma, Nasal stuffiness and the PFIZER BIONTECH COVID-19 VACCINE was probable; events Rheumatoid arthritis flare up and Stress for the PFIZER BIONTECH COVID-19 VACCINE was not reported.  The reporter's assessment of the causal relationship of the events fever and aches with the suspect product PFIZER BIONTECH COVID-19 VACCINE was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.; Sender's Comments: Based on the information currently available, The casual association between the reported events with suspected vaccine BNT162B2 cannot be completely 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.
So far 12 hours of pain, body aches, chills and fever. Taking Tylenol and Benadryl
Noticed a tremor in my right hand the next day.  That has developed into a increasing tremor that has spread to head, hands and moving into legs. Unable to work or drive. I have seen a neurologist who prescribed Primidone 50mg for essential tremor.  Unable to take prescription due to  side effects.
Extreme pain in left arm from shoulder to elbow - underarm swollen - couldn't move arm - headache on left side of head only - rapid heartbeat, area hot, swollen - couldn't sleep - no appetite. Couldn't make myself get out of bed Oct. 31 a.m. Finally forced myself to get out and dressed and report to facility Immunization condition.
This spontaneous report was received from a medical assistant concerning an approximately 18 year old female patient. The patient was vaccinated with dose 1 GARDASIL (lot number, expiry date, dose, route unspecified) on 16-AUG0-2012, On an unknown date in October 2012, the patient was vaccinated with dose 2 GARDASIL (lot #, expiration date and route not reported) and on 10-JAN-2013, the patient was vaccinated with dose 3 GARDASIL (lot #, expiration date and route not reported). The patient forgot that she had received a dose of GARDASIL in October at her college. No concomitant medications were reported. No adverse effect was observed or reported at the time of reporting. Additional information has been requested.
Nausea; Vomiting; Headache; This spontaneous case was reported by a health care professional and describes the occurrence of NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Urticaria, Angioedema and Pruritus.    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 NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache). At the time of the report, NAUSEA (Nausea), VOMITING (Vomiting) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment drugs were not provided  Concomitant medicines were not included.  Upon internal review on 04-Aug-2021, the age was corrected to 52 years.   Action taken with mRNA-1273 in response to the event was unknown
Patient tested positive for COVID-19 after completing the full vaccine series, 49 days after 2nd dose.   Patient received 2nd dose of COVID vaccine on 1/21/21 .   Tested positive on 3/11/21.   NOT hospitalized.
Large local reaction, Left upper arm, Red, warm, tender, 7 X 10 cm
Terribly achy and sore; Extreme tiredness; This is a spontaneous report from a contactable consumer (patient).  A 46-year-old female patient received bnt162b2 (BNT162B2), via an unspecified route of administration on 19Feb2021 13:45 (Batch/Lot number was not reported) as single dose at the age of 46-year-old for covid-19 immunisation, administered at hospital.  Medical history was none. The patient's concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient has not received other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced terribly achy and sore, extreme tiredness on 20Feb2021 12:00 with outcome of recovered in Feb2021.  No treatment received for the adverse events. The events were considered non serious. Since the vaccination, the patient has not been tested for COVID-19.  Follow-up attempts completed, Information on the lot/batch number has been requested and cannot be obtained. No further information expected.
Cramps in legs; Arthritis; Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps in legs), ARTHRITIS (Arthritis) and ABDOMINAL PAIN UPPER (Stomach pain) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect product included non-company product PANCREATIN (CREON) for an unknown indication.    There was no reported medical history.    On 01-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started PANCREATIN (CREON) (Oral) at an unspecified dose. On an unknown date, the patient experienced MUSCLE SPASMS (Cramps in legs), ARTHRITIS (Arthritis) and ABDOMINAL PAIN UPPER (Stomach pain). At the time of the report, MUSCLE SPASMS (Cramps in legs), ARTHRITIS (Arthritis) and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       It was unknown if patient was enrolled in COVID-19 vaccine trial. Concomitant medications were not reported. Treatment medications were not reported.  Company comment: This is a spontaneous case concerning a unknown age, male patient with no medical history reported, who experienced the unexpected non serious events of arthritis, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a unknown age, male patient with no medical history reported, who experienced the unexpected non serious events of arthritis, which occurred unspecified days after a dose (dose number not specified) of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
3 years ago I had one dose, did not get the second; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingrix (1st dose received 3 years ago from the day of reporting).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not applicable for this report. The patient did not get the 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination.  The reporter also asked could he/she get the 2nd dose now or do start over. No contact details were reported.
Headache, severe muscle pain, fatigue, chills, fever all beginning by 5 am 3/14/2021 and lasting into 3/15/3021
Patient received a PREVNAR 13 vaccine in her left arm following a FLUZONE HD injection on 10/5/15. She returned to the pharmacy on 11/9/15 with redness and swelling at the injection site, in addition to, complaints of back pain and vomiting dating back to the day of injection.
Initial solicited report received on 21 September 2017 from an investigator (Defense Health Agency) in the trial. A 22 year-old male subject with no significant medical history.  The subject's concomitant medication was not reported. The subject received a dose of ACAM2000 (lot number, site of administration not reported) on 11 April 2017. On 27 April 2017, 11 days after vaccination the subject was diagnosed with I31.9 disease of pericardium, unspecified. For subject, Troponin I value 00.99, abnormal done on 21 April 2017, ECG not performed, Echocardiogram normal done on 24 April 2017. MRI of brain, spinal cord, heart, Lumbar puncture (spinal tap) were not performed. The subject's treatments were not reported. The outcome of the event, I31.9 disease of pericardium, unspecified was not reported. Relationship to investigational product according to company: associated Additional information will be requested from the investigator. Note: There is no reporter causality assessment as this is a safety surveillance (data mining, non-interventional) study. List of documents held by sender: none.; Sender's Comments: This case involves a healthy 22-year-old male subject who developed acute pericarditis unspecified and unspecified disease of pericardium with favorable temporal association post vaccination with ACAM2000. Pericarditis and pericardial disease are listed event for ACAM2000 vaccine. Alternative etiologies could be Myocardial infarction, pulmonary embolism, Pneumonia, Costochondritis, pneumothorax. History of allergies or trauma was not reported. In the absence of additional information on confirmation of diagnosis with CK-MB assays, biopsy, role of study vaccine can not be ruled out.
Hives on face and neck 1 hour after vaccine given, treated with Claritin 1.25ml once, and hives resolved.
This spontaneous report was received from a registered nurse and refers to a 4 years old patient of unknown gender. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On 11-OCT-2018, the patient was vaccinated with one dose of M-M-R II not valid lot number reported as N026829, expiration date 27-SEP-2019 (route of administration was not reported). In the same office visit, the patient was vaccinated with PROQUAD lot number R007682, expiration date 11-SEP-2019 (route of administration was not reported) (overdose, inappropriate schedule of vaccine administered). No adverse effects were reported.
Pain; Fever; Chills; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain), PAIN IN EXTREMITY (sore arm), PYREXIA (Fever) and CHILLS (Chills) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 24-Mar-2021, the patient experienced PAIN (Pain), PYREXIA (Fever) and CHILLS (Chills). On 26-Mar-2021, PAIN (Pain), PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medication was reported.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Follow up received on 14-MAY-2021: contain no new information On 28-Jun-2021: Follow up received on 28-JUN-2021: contain no new information
The morning after I woke up, I had intense abdominal cramping. The cramping was high in the gut area. I figured it was an adverse side effect. The cramping did not subsist night or day and the intensity was great. I called my GI on Monday and got an appointment. When I saw him, he ordered a CT scan and put me on a strong antibiotic thinking that it was an infection, not related to the vaccine. Meanwhile I had a CT scan and blood workup. The CT scan came back with significant swelling and inflammation in my small intestines. Five miserable days later my GI took me off of the antibiotic and was now talking about putting my on a strong steroid. (Budesonide) Then, due to tremendous cramping I went to the ER where they did another CT Scan, blood workup as well. They did see less swelling and that gave us hope that the steroid was working. Finally, I got a endoscopy where they took six biopsies. We are still waiting on the biopsies but they doctor said the inflammation was going done but that my stomach lining was particularly red. That is where it stands today just past one month. The pain is going down but both of my healthcare professionals are warned me against getting the second dose of the vaccine. They are both convinces this is a rare type of allergic reaction to the vaccine.
Tiny blisters; Itchy rash; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6203) via an unspecified route of administration in the arm left on 25Mar2021 at 10:00 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. Medical history included rheumatoid arthritis. The patient had allergic reactions to pneumonia vaccine and rheumatoid arthritis medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included upadacitinib (RINVOQ), hydroxychloroquine (MANUFACTURER UNKNOWN), pilocarpine (MANUFACTURER UNKNOWN) and rosuvastatin (MANUFACTURER UNKNOWN). The patient did receive other unspecified vaccine within four weeks prior to the vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: P6955) via an unspecified route of administration in the arm left on 04Mar2021 (at the age of 47-years-old) as a single dose for COVID-19 immunisation. On 29Mar2021 at 16:00 (Monday afternoon) the patient started developing an itchy rash with some tiny blisters. On 01Apr2021 (Thursday), it covered almost completely on the patient's back, arms, and legs, and to a lesser extent my chest, neck, and face. The events did not result in doctor or other healthcare professional office or clinic visit, and emergency room or department or urgent care. Therapeutic measures were taken as a result of events which included treatment with Zyrtec twice a day since 30Mar2021 (Tuesday) and did put triamcinolone acetone on it on 01Apr2021 (Thursday) night. The clinical outcome of events tiny blisters and itchy rash were recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Headache, Myalgia, Fever, Injection site pain, chills, hot flashes  Narrative:
HYPOXEMIA 2/16/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
cold with laryngitis, sore throat, turning into sinus infection with persistent cough, aches in jaw and teeth, plugged ears