chrisvoncsefalvay/vaers-outcomes huggingface dataset:
At 11:05 after client had held her children receive Covid -19 Vaccine client became pale and stated feeling flush and heart beating fast and was sweating. Moved from administration area to Post Vaccination area ambulatory. Given a bottle of water and V/S taken  B\P 136/84 P82/R 34. Advised to slow breathing take long slow breaths. States she is feeling a little better snack given. Also advised will observe for 30 minutes because she states she is becoming flush again but heart is beating normally. V/S taken B/P 120/80 P80 R24. 11:20 Patient continues to feel flush given more water with continuous observation. She states this is why I hadn't gotten shot, asked if she had ever had reaction to any other vaccination she said no. Advised her some people react differently when  a new medicine is introduced into system. V/S retaken B/P 120/80P80R20 . Her color continues to be pale and feeling flush . She states I need to leave advised against her leaving but was insistent. Encouraged her to go to urgent care/emergency room if she develops rash or becomes short of breath or continuous heart palpitations states understanding and leaves ambulatory.
Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2 (BNT162B2), on 15Mar2021 as dose 1, single (Lot number: EN6207), in left arm, on 05Apr2021 as dose 2, single (Lot number: ER8737), in left arm and on 15Dec2021 as dose 3 (booster), single (Lot number: FH8028) at the age of 55 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "hypothyroidism" (unspecified if ongoing); "cardiovascular disesase" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN, start date: Feb2019, stop date: 15Aug2022; LEVOTHYROXINE, start date: Feb2002. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive; (24Aug2022) Negative, notes: tested negative 2 days ago; (26Aug2022) Negative, notes: tested positive today. Therapeutic measures were taken as a result of vaccination failure, covid-19.
This spontaneous report was received from a nurse practitioner refers to a 17 year old female patient. The patient did not have any pertinent medical history or drug reactions/allergy. On 15-OCT-2012, the patient was vaccinated with a first dose of 0.5 ml (milliliters) GARDASIL, (lot number H010124, expiration date 16-JAN-2015, route- intramuscular on right arm). Other suspect therapies included VARIVAX (Merck) and MENACTRA on 15-OCT-2012. The patient did not take any concomitant medications. On 16-OCT-2012, the patient experienced injection site reaction, nausea, fatigue, anorexia. The site of GARDASIL administration was red, hot and painful and was getting bigger. There were no laboratory diagnostics performed. Treatment rendered for the events were unspecified. The outcome of the events were reported as not recovered at the time of this report. The patient sought medical attention (office visit). Additional information has been requested.
fever; stomach ache; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program Covax Us Support.  A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. Previously on an unknown date received the first dose of the vaccine for covid-19 immunisation.The patient medical history and concomitant medications were not reported. On an unknown date, after she got the 2nd dose of vaccine, the patient experienced fever and stomach ache.  The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot been obtained.
25FEB97 11PM elevated temp, vomiting, stomach cramps;26FEB97 AM temp still elevated, shrill cry;being taken to MD 28FEB97; physician visit no more DTP by MD order;vomiting has ceased, but low grade temp cont;
Severe uticarial reaction that developed over the course of 3 or 4 days that began to cause difficulty swallowing. I was driven to the ER where I was treated with IV steroids and Benadryl. I was prescribed a 6 day oral steroid treatment and pepcid to take mornings and nights
Swelling, numbness & tingling L shin & foot, then swelling R thigh, numbness/tingling R foot x 1 wk. Resolved in 1 wk. Then L shin/foot swelled w/numbness tingling along shin.
No additional AE details were provided; patient who received their first dose of MMR-II and VARIVAX 7 days too early. The caller states that the patient turns 12 months old on 1NOV2022 and that was when she should have received.; This spontaneous report was received from a medical assistant regarding a 11-month-old patient of an unknown age. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-OCT-2022, the patient was vaccinated with the first doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) 0.5 ml, lot #W009104, expiration date: 04-DEC-2023, administered subcutaneously, as prophylaxis; and  varicella virus vaccine live (oka/merck) (VARIVAX) 0.5 ml, lot #W017551, expiration date: 01-JUN-2024, administered subcutaneously, as prophylaxis (Product administered to patient of inappropriate age). It was stated that the patient was vaccinated 7 days too early. No adverse events were reported.; Sender's Comments:  US-009507513-2210USA009786:
This spontaneous report as received from nurse practitioner refers to two unspecified patients of unknown demography. On an unknown date, the two patients were inadvertently administered improperly stored VARIVAX (Merck) (Lot # L015045 (29-APR-2017), lot # L035129 (14-SEP-2017) (dose and frequency were not reported). No adverse effects reported. The nurse reported that it was not known whether one or both lot numbers were administered. The temperature of VARIVAX (Merck) storage was reported as -13.5 degree Celsius. Time frame was reported as 30 minutes. No product quality complaint (PQC) was involved. The outcome of the events was unknown. The reporter did not provide the causality between the events and the suspect therapy. Additional information is not expected as the reporter did not wish to be contacted.
Client received 0.5 ml dose as booster dose instead of 0.25 ml dose of Moderna on Friday 11/19. F/u call on 11/24. Pt reports that the 1 day post vaccine " he had no energy and felt crummy on Saturday,  just the one day, but feeling better now".
died; This is a spontaneous report from a non-contactable consumer via a Pfizer-sponsored program. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported the patient was a doctor, died after the vaccine with no apparent disease. It was not reported if an autopsy was performed.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Reported Cause(s) of Death: Unknown cause of death
Patient reported that she had a reaction from her first dose, which was administered 10/25/2018. Patient reported that within a day of the immunization she experienced swelling, redness and bumps at the injection site. It lasted approximately 2 months and then began gradually going down. Patient saw her dermatologist about a month after the immunization and was advised to use her steroid cream for the area. She reported that by January the swelling and redness were gone but she still experienced itchiness and bumps. At this time patient reports that the area is still dry, bumpy and itchy.
Mucus; sneezing; cut body; tiredness; This is a spontaneous report from a non-contactable consumer (patient herself). A 24-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in Arm Left in 2021 (at the age of 24 years old) as dose 1, single for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient was not pregnant at time of vaccination. On 06Aug2021 the patient experienced mucus, sneezing, cut body, tiredness. The patient underwent lab tests and procedures which included sars-cov-2 test was negative on 04Aug2021 Nasal Swab. The patient did not receive any treatment or no prolonged hospitalization for the events. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.
Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     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 after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine after the manufacture date of expiration/Dose administered after 30-day use by date or after manufacturer date of expiry) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  It was reported that vials had not undergone any temperature excursion. Total of 168 doses/vials were given from LOT 048C21A.  Date the vial was initially stored in the refrigerator was reported as unknown.  No treatment medication were reported.   Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2022: Follow up contains non significant information.
Patient instantly became hot and shaky. She began sweating and her face became red. She stated she felt nauseous and felt as though her heart was racing.  I followed up with the patient 2 days after the incident to see how she was doing. she claimed to be bed ridded for the rest of the day after her vaccination and felt extremely tired and not herself for 2 days. pt claimed to finally begin feeling like herself again on day 3.
arm weakness; Dizzy; all in the upper left arm muscle which remained sore for several days each time; headache; Fatigue; general feeling of being unwell; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (general feeling of being unwell), MUSCULAR WEAKNESS (arm weakness), DIZZINESS (Dizzy), VACCINATION SITE PAIN (all in the upper left arm muscle which remained sore for several days each time) and HEADACHE (headache) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced MALAISE (general feeling of being unwell), DIZZINESS (Dizzy), VACCINATION SITE PAIN (all in the upper left arm muscle which remained sore for several days each time), HEADACHE (headache) and FATIGUE (Fatigue). On 20-Feb-2021, the patient experienced MUSCULAR WEAKNESS (arm weakness). In February 2021, MALAISE (general feeling of being unwell), DIZZINESS (Dizzy), HEADACHE (headache) and FATIGUE (Fatigue) had resolved. In 2021, VACCINATION SITE PAIN (all in the upper left arm muscle which remained sore for several days each time) had resolved. At the time of the report, MUSCULAR WEAKNESS (arm weakness) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant information was reported. Patient had injection, in the upper left arm muscle which remained sore for several days. Patient received second shot on 17-Feb-2021, event began about 3:00am and lasted 12 hours that was dizzy, headache, fatigue, general feeling of being unwell and then arm weakness started 4 days later. No treatment information was reported.   This case was linked to MOD-2022-669893, MOD-2022-668051, MOD-2022-662883, MOD-2022-662837 (Patient Link).
Wrong resident verbally consented to receive bivalent booster. Monitored by nursing staff post vaccination. No adverse reactions reported.
Was seen by specialist due to colitis flare and was told symptoms started after GARDASIL was given. Also had fatigue, body aches, irregular menses and Crohns disease flare. GARDASIL was given in 2007.
Not an adverse event. Pt has tested positive for Covid after being fully immunized. Pt has dry cough and feels a little run down but otherwise feels well overall. No fevers, no dyspnea. Exposure to daughter and son in law who are Covid positive. Is not hospitalized. Seems to be recovering well.
Arm is swollen where injected; Arm is warm and red; arm is warm and red; A spontaneous report was received from a consumer concerning a 49-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Injection site swelling, arm was warm and red.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 025L208) intramuscularly in the arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the injection site swelling, arm is warm and erythema.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events injection site swelling, arm is warm and red were unknown.; Reporter's Comments: This case concerns a 49-year-old female patient who experienced the non-serious expected events of Injection site swelling, Injection site erythema and Injection site warmth. The events occurred on an unknown date after receiving their first of two planned doses of mRNA-1273 (Lot 025L208) intramuscularly in the arm for prophylaxis of COVID-19 infection. Treatment information is not provided. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events of are considered possibly related to the product.
This injection was the 2nd of 2 doses. First was delivered in January 2020.  I had significant side effects with the first injection including chills, teeth chattering, significant arm swelling, fatigue, pain in arm etc. I was ill for 4 days.  The second injection has been much less severe from a side effect perspective however there was 1 new side effect that I experienced but did not note on any of the product literature.  The side effect was insomnia.  I could not fall asleep from midnight to when I got up at 7 AM.  This is very unusual for me as I am usually a sound sleeper.
I have developed diarrhea and I am pretty sure it''s because of the booster shot; Fatigue; Low grade fever; I originally got the J&J shot which was done in March; two days ago, I got the Pfizer booster; I combined the two, if that was a bad thing to do; I originally got the J&J shot which was done in March; two days ago, I got the Pfizer booster; I combined the two, if that was a bad thing to do; The day after the booster, my arm was extremely sore; hot; slightly swollen; This is a spontaneous report from a contactable consumer or other non hcp. A 65-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EW0196) via an unspecified route of administration, administered in Arm Left on 01Nov2021 13:00 as dose 2, single for covid-19 immunization (at the age of 65 years). Medical history included chronic obstructive pulmonary disease, emphysema, asthma, blood cholesterol increased, thrombosis, gastrooesophageal reflux disease, arthropod sting and penicillin.  Concomitant medication included montelukast sodium (SINGULAIR), omeprazole, aspirin [acetylsalicylic acid] (ASPIRIN), atorvastatin, calcium, colecalciferol (CALCIUM PLUS VITAMIN D), and fluticasone propionate (FLONASE), and Albutamol (albuterol). The patient was not tested covid positive post vaccination. The patient did not experienced covid prior vaccination.The patient previously took janssen covid-19 vaccine (lot number unknown) via an unspecified route on an unspecified date for covid-19 immunization, and experienced hypersensitivity, and demerol and experienced hypersensitivity. The patient originally got the J&J shot (Later clarified as first COVID-19 vaccine J&J) which was done in March On 01Nov2021 day of shot, in the evening, patient was extremely sore, hot, slightly swollen.On 02Nov2021 she was fatigued, listless, had a low-grade fever of 100.9. That all lasted until evening. 03Nov2021 after lunch, about noon, she developed diarrhea.The patient underwent lab tests and procedures which included body temperature: 100.9 on an unspecified date. The outcome of all events was not recovered.   Follow-up attempts are completed. No further information is expected.
Non itchy rash on the left cheek; A spontaneous report was received from other health care professional concerning a 56-years old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced non itchy rash on the left cheek.  The patient's medical history was not provided. Concomitant medications included Plaquenil for Sjogren Syndrome.  On 02 Jan 2021, the patient received their first of the two planned doses of mRNA-1273 (lot number: unknown) intramuscularly for the prophylaxis of COVID-19 infection.  On 02 Jan 2021, the patient experienced non itchy rash on the left cheek.   Treatment medication included Benadryl.  No lab tests were mentioned.  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event non itchy rash on the left cheek was considered recovered/resolved.; Reporter'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.
Rash on torso and hand; This is a spontaneous report from a contactable consumer. A 49-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in the left arm in Jan2021 (Batch/Lot number was not reported) as dose 2, single (at the age of 49-years-old) for Covid-19 immunisation. There was no medical history, no known allergies and no concomitant medications. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in the left arm in Jan2021 (Batch/Lot number was not reported) as dose 1, single (at the age of 49-years-old) for Covid-19 immunisation. The patient had no other vaccine in four weeks and no other medications in two weeks. The patient had no Covid prior vaccination and unknown if the patient was tested for Covid post vaccination. In Feb2021, the patient had a rash on torso and hand appearing approximately 2 weeks after the second dose. No treatment was administered for the event. The outcome of the event was not resolved.   No follow-up attempts are possible; information about batch/lot number cannot be obtained. No further information is expected.
Myalgia, Fever, fatigue, Chills, HA, Sinus congestion, Difficulty breathing, Dry cough  improving
Has dizziness when he wakes up; He has stiffness on the left; Tingling on the left side of body/Tingling from arm to knee; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS, PARAESTHESIA, and DIZZINESS in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 032B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Enlarged prostate.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced MUSCULOSKELETAL STIFFNESS and PARAESTHESIA. On an unknown date, the patient experienced DIZZINESS. At the time of the report, MUSCULOSKELETAL STIFFNESS, PARAESTHESIA and DIZZINESS had not resolved.            Concomitant list included medication for enlarge prostate.  No treatment medications were reported.
DTAP, MMR, Influenza given on 11-29-2006 started small red area on right thigh this am, now enlarged. No fever, or chills just itches on this evening. Ice pack to arm pain. Benadryl 12.5 mgs/5mls/5 ml take 5 ml PO four times a day as needed.
Death A41.50 - Gram-negative sepsis, unspecified K81.0 - Acute cholecystitis E86.0 - Dehydration E83.42 - Hypomagnesemia N39.0 - Urinary tract infection E87.2 - Respiratory acidosis R06.89 - Hypercarbia T85.518A - Cholecystostomy tube dysfunction, initial encounter D72.829 - Leukocytosis, unspecified type
Has the patient ever tested positive for Covid 19? Yes/believes it was 2 months ago; Has the patient ever tested positive for Covid 19? Yes/believes it was 2 months ago; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): MOD22-022013 (Moderna).  A male patient received BNT162b2 (BNT162B2), on 19Mar2021 as dose 1, single (Lot number: FEA092681), on 09Apr2021 as dose 2, single (Lot number: ER8734) and on 18Nov2021 as dose 3 (booster), single (Lot number: FH8028) for covid-19 immunisation; coviD-19 vaccine mrna (mrna 1273) (MODERNA COVID-19 VACCINE), on 17Aug2022 as dose 4 (booster), single (Lot number: 006M21A) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Has the patient ever tested positive for Covid 19? Yes/believes it was 2 months ago". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Has the patient ever tested positive for Covid 19? Yes.  Clinical course: Description of Patient was administered with a booster dose of the Moderna Covid 19, after its expiration date. Event or Problem: Vaccine expired on 13Aug2022 and he received it on 17Aug2022. There were no allergies. The patient has tested positive for Covid 19, but HCP does not remember exact date. Believed it was 2 months ago.; Sender's Comments: Based on the information in the case, an association between the reported events vaccination failure and covid 19 and the suspect product bnt162b2 cannot be ruled out.