chrisvoncsefalvay/vaers-outcomes huggingface dataset:
chest pains; Ejection fraction decreased (from 40 down to 20); This is a spontaneous report from a Pfizer-sponsored program "Covax US Support"received from a contactable consumer reporting for himself. A male patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech), via an unspecified route of administration, on an unspecified date, at single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Previously the patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer-BioNTech) for COVID-19 immunisation. The patient experienced chest pains and ejection fraction decreased (from 40 down to 20) both on an unspecified date with outcome of unknown. The patient underwent lab tests and procedures which included ejection fraction: from 40 down to 20 on unknown date. The events were considered serious as caused patient's hospitalization.  The information on the lot/batch number has been requested.
Began complaining of blurry vision in BOTH eyes that has progressive gotten worse beginning 3 hours after exmination
Since the second vaccine, I have noted palpitations, heart inflammation and afib.  Previously I have never experienced any health problems related to my heart. I have also taken an extensive physical every year including treadmill stress tests that have shown healthy heart. These symptoms are almost a daily occurance now and I am currently seeking treatment for these problems.
soreness @ inject site on 16APR93 & fine rash on lt arm; welt on lt arm; some on face; 17apr-94 temp 99 by mouth; joint soreness in shoulders both upper back hips, rt wrist; wrists has bothered pt before; soreness in neck & hurts to swallow
Headache & Myalgia Narrative:  sore arm 2nd day, headache first and second day
weak; loss of appetite; covid test result=Positive; received the third dose of BNT162B2; received the third dose of BNT162B2; This is a spontaneous report from a contactable consumer. An unspecified age male patient received the third dose of BNT162B2 (COVID19 Vaccine) via an unspecified route of administration in Oct2021 as single dose for COVID-19 immunization. Medical history was not reported. Prior to vaccination, it was unknown whether the patient diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. Concomitant medication included influenza vaccine. The patient previously received the second dose and the first dose of BNT162B2, both via an unspecified route of administration on an unspecified date (Batch/Lot Number: Unknown) as single dose for COVID-19 immunization. In Oct2021, the patient experienced individual weak and loss of appetite. In Oct2021, the patient performed covid test (type was unknown) and result was positive. The events of weakness and appetite lost resulted in emergency room/department or urgent care. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
From Thursday March 25 I began to feel strong nauseous throughout the day. The next day, Friday, March 26, I got up at 5am to work and could not stand up with severe dizziness, everything was spinning and after 15 minutes I began to vomit for about 2 hours with 20-minute breaks. Later that day I visited a doctor and according to my description he thinks that it may be vertigo, the Doctor has no history of my record, she is not my family doctor, but to be sure he sent me to do laboratories which he carried out today March 29. I just want to know if it could be side effects of the vaccine.
STOMACH CRAMPS; SORENESS; INJECTION SITE SORENESS; SEVERE HEADACHE; NAUSEA; TIREDNESS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 12-MAR-2021 03:30 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced stomach cramps. On MAR-2021, the subject experienced soreness. On MAR-2021, the subject experienced injection site soreness. On MAR-2021, the subject experienced severe headache. On MAR-2021, the subject experienced nausea. On MAR-2021, the subject experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injection site soreness, severe headache, nausea, stomach cramps, tiredness and soreness was not reported. This report was non-serious.
Vasovagal syncope 5 minutes post vaccination. Patient regained consciousness in chair in observation room 2 minutes after fainting. Vital signs at baseline: blood pressure 59/34, heart rate  44, respiration 22. Vital signs at patient discharge 40 minutes later: blood pressure 105/80, heart rate  74, respiration 18.
Vaccine breakthrough, symptomatic. 9/17   Inpatient admit 9/17 to present,
Her grand mother passed out and almost died; Her grand mother passed out; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID.  A female patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Heart complications" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (medically significant), outcome "unknown", described as "Her grand mother passed out and almost died"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "Her grand mother passed out". Clinical Course: Caller stated that her grandmother recently received the vaccine passed out and almost died. Her grandmother had heart complication.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300108185 same reporter and drug, different patient and event;
57 M w/ hx of asthma, alpha thalassemia, pre DM2 presenting with fever/cough/dyspnea in setting of COVID pneumonia.   Pt presenting with severe sepsis in setting of COVID pneumonia. Symptoms started on 9/14 with scratchy throat, productive cough, DOE, fever. COVID + on 9/18/21. Received J&J vaccine in Apr 2021. O2 requirements only ever up to 3 L NC, discharged with 1-2 L NC at rest and with exertion as needed. S/p 5 day course of Remdesivir, to finish off 10 day course of decadron. Of note, also received 5 day course of CTX/doxy as focal infiltrate on imaging and neutrophilic predominance more suggestive of bacterial pneumonia. - Finish 10 day course of decadron - O2 clinic referral sent   Primary Procedures:  None   Secondary Procedures: None   Reason for Hospital Admission (Admitting Diagnosis):  COVID pneumonia
Patient developed diffuse urticaria on 5-23-2021 for which she was seen in emergency room and later in the office.  Symptoms persisted over a week.  Parents requested that I submit a VAERS form
Pt was vaccinated and was found to be complaining of swelling in his throat and was feeling lightheaded. He was given 50 mg of Benadryl. Patient was assessed after and his vitals were within normal range. He was fine and was picked up by his son to go home.
Became ill w/vomiting almost immediately after receiving vaccine. Pt was put in an exam room to lie down, BP taken (ok). Advised to remain at office for observation (which is routine after this vaccine, for 15 minutes) and wait for a second BP. Pt left before being released by the Medical Assistant.  Follow up phone call a few hours later revealed that the patient continued to vomit for a few hours after leaving the office. Home to rest and push fluids, Mom was advised to call the next day if still any symptoms.
Injection Site Soreness/Pain; This is a spontaneous report from a Non-contactable other HCP. This other HCP reported for a 40-year-old male patient that received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number= EK5730), intramuscular on 04Jan2021 at single dose for COVID-19 immunisation. Age at vaccination was 40-year-old. Vaccine location was Left arm. The patient's medical history and concomitant medications were not reported. The patient experienced Injection Site Soreness/Pain. The event was reported as non serious. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient has not been tested for COVID-19. The outcome of the event was unknown.   No follow-up attempts are possible. No further information is expected.
Localized sharp pain when moving and lifting the right arm. Pain does not radiate anywhere. I feel it in the muscle. Unable to lift arm higher than shoulder without feeling sharp pain. Pain has been going on for a month.
190 patients (9 different lot numbers) received a vaccine past the beyond used by date; No Adverse Event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (190 patients (9 different lot numbers) received a vaccine past the beyond used by date).    This case was created for 53rd of the 190 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 Vaccine. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-704335 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-704335:Master case
Mother reports fever of 105 nine hours after administration of vaccines. Pt was given a single dose of TYLENOL and symptoms resolved within 1 hour. No further problems or other symptoms.
Exacerbation of fibromyalgia symptoms (neck pain, lower back pain, flu- like symptoms). Loose bowels after evening meal for over a week. Itchy burning rash at original shingles site for 5 days. Rash gone but several times a day itch and burn at the site. On and off flu like symptoms continue, headaches and sinus problems.
Pt reports today 4/20-   (No new meds, topicals,  foods, etc.) Over the past 2 days (beginning evening 4/17) I have developed a full body rash. Red, blotchy, itchy hives. This covers ears, neck, arms, hands, back, stomach, and legs. I have been able to treat at home using Benadryl, Calamine, and Cortizone. I don't think I need to be seen because the OTC products are helping, but I wanted to make this known since the vaccine is still so new. "
Charley-horse; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Charley-horse) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 045A21A) for COVID-19 vaccination.     Concurrent medical conditions included HIV infection (undetectable HIV).   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Charley-horse). At the time of the report, MUSCLE SPASMS (Charley-horse) outcome was unknown.            No Concomitant product use was reported.  The patient experienced charley-horse post receiving their second dose. Reportedly, the patient stated they had a past medical history of undetectable HIV.  No treatment information was provided.   This case was linked to MOD-2021-419311, MOD-2021-419280 (Patient Link).
Temp 103 site red, swollen x 4 days site tender with hard nodule up to present. Given Rocephin x2 and Cefzil x 10 days
She had 3 HPV shots (7/29/2010, 1/11/2011, 7/17/2012) each time afterwards had muscle pain, joint pain, was diagnosed with RND one year afterwards, later retracted, diagnosed with dysautonomia 08/10/2013 and is now confined to wheelchair.
then got positive for covid on 22Mar2021; positive COVID-19 test (22Mar2021) with symptoms; This is a spontaneous report from a contactable consumer. This 51-year-old female consumer reported for herself that the patient has received the first dose of BNT162B2 (COMIRNATY, Formulation: Solution for injection, Lot number: EN6205) via an unspecified route of administration in left arm on 04Mar2021 as single dose for COVID-19 immunization, Protection, preventing the spread (Age at the time of vaccination:51-year-old). The patient's medical history included occasional hypertension and high cholesterol and concomitant medication included Lipitor 10mg by mouth for high cholesterol. On 21Mar2021 the patient had dry cough. On 22Mar2021 she tested positive for Covid. She is getting mixed information from the CDC and her doctor as to when it is safe or necessary to get the second dose of the vaccine. She confirms this as the Covid vaccine. Her symptoms started on 21Mar2021.On 22Mar2021 the patient had very low-grade fever and the event resolved on 23Mar2021, on 24Mar2021, the patient had congestion, had loss of taste and loss of smell. The patient reported that she had a dry cough, a very low-grade fever for one day, congestion, and loss of taste and smell. She had lasting effects because she had Covid last Mar also. She had a mild cough, that had not changed. She was just a little congested and her taste and smell are muted. She has mild congestion when she wakes up in the morning. It started a couple of days after she tested positive. She lost her sense of taste and smell Thursday or Friday, 25Mar2021 or 26Mar2021. Some things she can taste and some things she cannot. The patient was not received any treatment for the events. The outcome of the events were reported as unknown.
10:20 am Approximately 15 minutes after receiving her COVID vaccine dose, patient reported dizziness and lightheadedness. Vitals BP 63/36, HR 80, 02 98% on RA. Pt A&Ox4, denied other symptoms 10: 25am: NS infusion initiated, repeat BP 5 minutes later 151/87, HR 96, 02 97%, no temperature, RR normal. Fluids discontinued 10:30am : Repeat BP manually 138/96, pt remained asymptomatic  ~10:45: EMS arrived & evaluated pt, BP 144/82, 98%, per EMS no intervention necessary   Primary MD made aware of pt's condition, no further interventions required  ~11:15am: BP 135/83, HR 86, 02 97%; pt denying any symptoms, able to ambulate with steady gait without dizziness or any further sx (CP, SOB, diaphoresis) ~11:30: Remains asymptomatic, pt discharged in no acute distress
First dose of MENACTRA administered. Subsequent urine pregnancy test was positive (same day).
pt recvd vax; hives over entire body; tx w/ prescription drugs; resolving;
Generalized itchy rash/macule upper chest/neck/upper back. No hives, SOB or chest pain. No wheezing.
Patient developed systemic itching to hands, under chin, face, and back of head. No change in diet. No new soap or laundry detergent. No contact with known allergens.
This case was reported by a physician via call center representative and described the occurrence of injection site erythema in a 18-year-old female patient who received BEXSERO (batch number 169821, expiry date 31st January 2019) for prophylaxis. Co-suspect products included TRUMENBA for prophylaxis. On 3rd August 2018, the patient received the 1st dose of BEXSERO (intramuscular) .5 ml. On an unknown date, the patient received the 1st dose of TRUMENBA. On an unknown date, less than a year after receiving BEXSERO, the patient experienced injection site erythema, injection site swelling and interchange of vaccine products. On an unknown date, the outcome of the injection site erythema and injection site swelling were recovered/resolved and the outcome of the interchange of vaccine products was unknown. It was unknown if the reporter considered the injection site erythema and injection site swelling to be related to BEXSERO. Additional details were provided as follows: The patient developed swelling and redness at injection site. No treatment provided to the patient. The patient received 1st dose of TRUMENBA, which led to interchange of vaccine products. This case is 1 of the 4 linked cases reported by the same reporter.
Received FLUZONE in (L) lateral thigh 11/17/12. Initially (1hr later) had pain, trouble walking & swelling- resolved with ibuprofen. 36 hrs later seen at medical center for swelling, redness, tenderness. Rx - Cephalexin. Resolved without complications.
This spontaneous report as received from a healthcare worker refer to an unspecified number of patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored of ZOSTAVAX, (dose, route of administration, injection site, lot number and expiration date were not reported). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In May 2022, the patient experienced COVID-19 (COVID-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) from 26-May-2022 to 30-May-2022 for COVID-19 treatment, at an unspecified dose and frequency. In May 2022, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative and negative (Negative) Negative.         No concomitant medications were reported.  The patient did not take any other medications/Products within 2 weeks of starting Covid-19 treatment.  Patient had previously received a covid-19 -Vaccine.  On 07-JUN-2022 Covid rebound occurred 8 days after symptoms disappeared and Tested Positive on antigen test and return of fever.  Device date: 07-JUN-2022  Company Comment: This is a spontaneous case concerning  a  57-year-old, male patient with no reported medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred on unknown date of May 2022, after the fourth dose of mRNA-1273 COVID 19 Vaccine which was administered on April 26, 2022. Patient was treated with nirmatrelvir and ritonavir from from 26-May-2022 to 30-May-2022 at an unspecified dose and frequency. Patient re-developed symptoms of Covid-19 on 07-JUN-2022 and tested positive on antigen test. The event was reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report. Sender's Comments: This is a spontaneous case concerning  a  57-year-old, male patient with no reported medical history, who experienced the unexpected non-serious event of Covid-19. The event occurred on unknown date of May 2022, after the fourth dose of mRNA-1273 COVID 19 Vaccine which was administered on April 26, 2022. Patient was treated with nirmatrelvir and ritonavir from from 26-May-2022 to 30-May-2022 at an unspecified dose and frequency. Patient re-developed symptoms of Covid-19 on 07-JUN-2022 and tested positive on antigen test. The event was reported as resolved. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Had pox, 8-9, nerves on top of back hurt and then itched.  Looked like chicken pox, went to Doctor and she confirmed it was Shingles.
I am a nursing mother and had breakthrough menstral bleeding for a week five days following my second dose. I had not gotten my period back and since then, have not had another. This is incredibly uncommon for my body and the ?period? I had following the second dose was not like my usual cycle. I know there is research being done about this so wanted to share.
blood usually come out; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection), 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's medical history and concomitant medications were not reported. Patient took the Vaccine and he/she noticed when they lady was giving him/her the shot, does blood usually come out questioned. The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Healthy male born 2009. Srong heartbeat detected at 9 weeks. No heartbeat at 10 and 1/2 weeks after the flu shot. Estimated delivery August 15, 2015
Side benefits, which were good; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Side benefits, which were good) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A, 016B21 and 010A21A) for COVID-19 vaccination.     The patient's past medical history included Poison oak rash (Skin problems on arm from poison oak scabs for 10 years.). Concurrent medical conditions included Heart disease, unspecified (Patient was bleeding all the time due to medicine for heart stuff.).   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 28-Oct-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Side benefits, which were good). On 28-Oct-2021, THERAPEUTIC RESPONSE UNEXPECTED (Side benefits, which were good) had resolved.            No treatment information was reported by the reporter. Patient took medicine for indication of heart stuff. Patient had an epidemiologist appointment to have the problem taken care of. He had his Moderna shot and now skin problems on his arm from poison oak and bleeding was all cleared up after a month.
I have developed vitiligo, I have patches on both the left and right wrist. No known family history.