chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Shingles; This is a spontaneous report received from non-contactable reporter(s) (Nurse). Other Case identifier(s): MOD-2022-530729 (Moderna).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "COVID-19", start date: 24Oct2021 (unspecified if ongoing), notes: Has the patient ever been diagnosed with/tested positive for COVID-19? Yes; "Multiple sclerosis" (unspecified if ongoing); "Deficiency" (unspecified if ongoing); "Cough" (unspecified if ongoing). Concomitant medication(s) included: BETASERON subcutaneous taken for multiple sclerosis, start date: 10Jul2021 (ongoing); VITAMIN D 2000 oral taken for hypovitaminosis (ongoing); FLUTICASONE PROPIONATE nasal taken for cough (ongoing). The following information was reported: HERPES ZOSTER (non-serious), outcome "unknown", described as "Shingles". Additional information: MODERNA COVID-19 VACCINE Information: Received Dose 1 on 28Mar2022 at 16:00Pm, Lot: 030H21B, Route and Body site: L deltoid, Dos/Volume:0.25ml. Dose 2,3,4 not received. Patient was pregnant. Allergies to medications, Food, and other products were reported as NKDA. Patient was diagnosed with/tested positive for COVID-19 on 24Oct2021. Acute illnesses at the time of vaccination and up to one month before was reported as None. Patient was given Expired vaccine on 28Mar2022 at 16:00 PM. Event did not cause the patient to seek medical care. It was unknown if the adverse event was most likely caused by mRNA-1273. Event outcome was reported as Recovered on 29Mar2022. Pt received expired vaccine for booster dose on 28Mar2022 Pt was called the next day, who stated she had experienced very mild sx after vaccination, much less than her first two Pfizer where she developed Shingles. She stated she developed a mild fever, HA, some body aches but these went away in about 24 hours. Pt notified, provider notified, Moderna communicated that adequate coverage was still maintained despite expiration.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Site: Itching at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: RASH ON ARM-Severe, Systemic: Unable to Sleep-Mild, Additional Details: PATIENT BROKE OUT IN RASH 2 TODAYS AFTER RECEVING 2 DOSE OF PFIZER COVID 19 VACCINE AND HE IS STILL ITCHING UNTIL NOW
Fever, Body aches, and chills. Loose stool. Started about 14 hours after receipt of 2nd vaccine dose.
After 5 minutes having the vaccine, felt flushing, dizziness, weakness, tongue numbness, heart rate increased, scratchy throat. Lasted for about two minutes, then went away. Then started to shiver which lasted about 10 minutes.
Severe, nearly debilitating knee joint pain in both knees. Lasted 5 days and required large frequent doses of aspirin in order to move about.
1st dose on 21Sep2020, 2nd dose 2 days ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 21st September 2020).   On 28-MAR-2023, the patient received the 2nd dose of Shingrix (intramuscular). On 28-MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose on 21Sep2020, 2nd dose 2 days ago). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 28-Mar-2023 and 30-Mar-2023 The patient received 2 days ago from the reporting date. The reporter consented to follow-up. The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. The case was linked with case US2023046729, reported by same reporter.; Sender's Comments:  US-GSK-US2023046729:Same reporter
pt recv vax 30JUN95 & & 24MAY97 pt devel 29 lesions, vomiting and t103;
CHEST PAIN; VOMITING; NAUSEOUS; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 14-JUN-2021 11:28 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 14-JUN-2021, the subject experienced chest pain. On 14-JUN-2021, the subject experienced vomiting. On 14-JUN-2021, the subject experienced nauseous. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from vomiting, nauseous, and chest pain. This report was non-serious.; Sender's Comments: MAC not required as per standard procedure for Non Serious cases.
This spontaneous report as received from a pharmacist refers to a patient of unknown age. The patient was vaccinated with a dose of MMR II (lot# unknown). No other co-suspects were reported. No concomitant medications were reported. The reporter stated that on an unknown date the patient failed to seroconvert the rubella portion after received a dose of MMR II. It was unknown that if the patient had sought medical attention. The outcome was unknown. Additional information has been requested.
w/in 24 hrs site of inject began to swell reaching max @ 48 hrs of redness & swelling from shoulder to elbow mildly tender & warm;
patient came in today 07/12/21 and mentioned since he got the vaccine on 06/21/21 he has been feeling  side effects , he mentioned his hear beat feels different , numbing , some chest pain, dizziness , I mentioned to the patient to schedule a visit to his doctor , in order to do more tests , and make sure everything is ok, patient he will reach out to the Dr today
Patient fully vaccinated with Pfizer on 3/18/21 and 4/8/21. Presented to ED on 12/30/21 with complaints of worsening shortness of breath and fatigue on 12/30/21. Patient has a past medical history of type 2 diabetes, hypertension, and obesity. Symptoms of Covid started 12/24/21. Patient was admitted for further evaluation and later discharged on 1/1/22.
AE: Diaphoretic( at 12pm). patient is Type II diabetic and has not eaten today. Treatment: no medication was given. patient was under observation.  Graham crackers and water improved symptoms Outcome: symptoms resolved and patient was sent to POV/Home.
administered a Covid vaccine that was for age range 12 and up to an 11 year old; patient had a sore arm after this vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician) from medical information team.  An 11-year-old female patient received BNT162b2 (BNT162B2), on 20Jan2022 as dose 1, 0.3 ml single (Batch/Lot number: unknown) at the age of 11 years intramuscular for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious) with onset 20Jan2022, outcome "unknown", described as "administered a Covid vaccine that was for age range 12 and up to an 11 year old"; PAIN IN EXTREMITY (non-serious) with onset 2022, outcome "unknown", described as "patient had a sore arm after this vaccine".  Additional information: In January they administered a Covid vaccine that was for age range 12 and up to an 11 year old that was 3 months shy of 12. Wanted to know if there was anything that they needed to worry about and what to do. The patient was on the scheduled for second dose on 14Apr2022 and that is when it was noticed that she was 11 years old when she got the first one. The patient was a couple days shy of 12. This was the patient's first dose. It should have been 0.3ml intramuscular injection in deltoid. Prior Vaccinations (within 4 weeks) If applicable, AE(s) following prior vaccinations, patient's medical history and relevant tests reported as none at the time of report and family medical history relevant to AE(s) reported as n/a. Product Details: It is the Gray top.    The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Feeling extremely tired; little bit nauseous; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received BNT162B2, (COMIRNATY, solution for injection, Lot number was not reported), via an unspecified route of administration on 29May2021 as 1st dose, single dose for Covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced feeling extremely tired, little bit nauseous on May2021. The patient enquired, how long this would last. Outcome of the event was unknown.   Information on the lot/batch number has been requested.
patient called today 5/20/23 stating that he had his second shingrix vaccine on Wed 5/17/23, and he smoke some weed on Wednesday night and some more, more than normal amount that he usually use on Thurs night.  He passed out on Thurs night, someone has to call an ambulance for him on Thurs night.  They checked him out and stated his blood pressure was fine, and he is awake, and he doesn't want to go to ER nor  Dr. office, but since Thurs, he has been dealing with some chest pain, the chest pain continue today.  He doesn't have a PCP.  I advised him to find a doctor or go to an urgent care clinic or ER if he think his chest pain need immediate attention.
6 hours after: chills (resolved 24 hours after dose given)  12 hours after:  left upper lateral deltoid stiffness & ache (resolved 48 hours after dose given) 26 hours after: fatigue, mild dizziness/wooziness, mild upset stomach, mild sore throat, very runny nose  (had to leave work 28 hours after dose; resolved 48 hours after dose given)
Drenching night sweats - every night since. Usually awakened by drenching night sweats between 3 and 4:40 am
hurt around the injection site; Injection site was red and puffed up; Injection site was red and puffed up; site remains hot; muscle is still tender when she moves it; She thinks they might have hit a nerve with the injection; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (hurt around the injection site), VACCINATION SITE ERYTHEMA (Injection site was red and puffed up), VACCINATION SITE SWELLING (Injection site was red and puffed up), VACCINATION SITE WARMTH (site remains hot) and MYALGIA (muscle is still tender when she moves it) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. 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) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced VACCINATION SITE PAIN (hurt around the injection site), VACCINATION SITE ERYTHEMA (Injection site was red and puffed up), VACCINATION SITE SWELLING (Injection site was red and puffed up), VACCINATION SITE WARMTH (site remains hot), MYALGIA (muscle is still tender when she moves it) and INJECTION SITE NERVE DAMAGE (She thinks they might have hit a nerve with the injection). On 24-Feb-2021, VACCINATION SITE PAIN (hurt around the injection site), VACCINATION SITE ERYTHEMA (Injection site was red and puffed up) and VACCINATION SITE SWELLING (Injection site was red and puffed up) had resolved. At the time of the report, VACCINATION SITE WARMTH (site remains hot), MYALGIA (muscle is still tender when she moves it) and INJECTION SITE NERVE DAMAGE (She thinks they might have hit a nerve with the injection) outcome was unknown.            No concomitant medication details was reported. No treatment medication details was reported. Action taken with mRNA-1273 in response to the events was not applicable.
Muscle aches, Chills, Tachycardia, Palpitations/arrhythmia (extrasystoles), Hypertension 180/100. Palpitation and tachichardia lasted for ~ 48 hrs, hypertension for over 4 days
One day following vaccination: headache, malaise, general body aches and fatigue. Four days following vaccination: dry hacking cough, headaches. Nine days following vaccination: productive cough with thick yellow sputum, headaches. Eleven days following vaccination:  productive cough with thick yellow sputum, headaches and occasional shortness of breath. Thirteen days following vaccination will be tomorrow (11/12/2012) and the soonest I will be able to contact my physician for treatment of the persistent and worsening cough.
(First shot)rush at the injection site; (First shot)sore arm; (First shot)body ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH ((First shot)rush at the injection site), VACCINATION SITE PAIN ((First shot)sore arm) and MYALGIA ((First shot)body ache) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN ((First shot)sore arm) and MYALGIA ((First shot)body ache). On 18-Jan-2021, the patient experienced VACCINATION SITE RASH ((First shot)rush at the injection site). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 05-Jan-2021 for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH ((First shot)rush at the injection site), VACCINATION SITE PAIN ((First shot)sore arm) and MYALGIA ((First shot)body ache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-043486 (E2B Linked Report). This case was linked to MOD-2021-043486 (Patient Link).; Sender's Comments:  MOD-2021-043486:Second dose Case
Patient did not receive full dose of vaccine due to becoming upset and jerking arm away.  Patient received approximately 3/4 of full dose.
Shortly after the shot I had an internal itchy feeling throughout my body. It got worse during the rest of the day. I paged my drs office that night and they suggested I take zyrtec which I did. The next day the itchy feeling had gone away but since then I have had a prickly type feeling throughout my body. I am going to contact my doctor again tomorrow.
After the first booster dose, she had Flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (After the first booster dose, she had Flu like symptoms) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INFLUENZA LIKE ILLNESS (After the first booster dose, she had Flu like symptoms). On 30-Nov-2021, INFLUENZA LIKE ILLNESS (After the first booster dose, she had Flu like symptoms) had resolved.            No concomitant medications were reported.  No treatment details were reported.   This case was linked to MOD-2022-549151, MOD-2022-549162 (Patient Link).
This spontaneous report as received from a physician refers to her husband (age unspecified). The patient's concurrent conditions and medical history were not provided. Two months ago, approximately on an unknown date in February, 2016, the reporter's husband was vaccinated with PNEUMOVAX 23 for immunization (dose, route, site of administration and lot# not reported). Concomitant medication was not mentioned by the reporter. On an unspecified date in February, 2016, the patient experienced injection site swelling and injection site erythema. No treatment was necessary for the events. The events injection site erythema and injection site swelling got resolved in 3 days. No further information was provided. Causality statement was not provided by the reporter. Additional information has been requested. This is one of the two reports received from the same reporter.
Patient presents with abdominal pain that started in the middle of the night.  Had first COVID vaccine the previous day.  Patient states the pain is intermittent "comes and goes" "cramping" "pressure and bloating" feeling. Patient states her normal bowel movements are 12 times per day.  The last time she went was this morning.  She is concerned about an "obstruction" Patient states she has "some nausea" She states she has ate and drank normally today.  Patient has a history of ulcerative colitis and a complete colectomy with a ileal rectal pouch.  She has had abdominal pain since this morning which is crampy, associated with nausea and recurrent vomiting.  She normally has 6-12 bowel movements a day, but none since this morning.  She does feel her abdomen is distended as well.  The last time she had anything like this was when she developed pouch itis last spring, but that was much less painful than this.  Her appendix is gone, but she believes she still has her gallbladder.
Angioedema on my face. Hives. Red raised bumpy rash covering inner arms, right side of body, chest, inner thighs, knees, groin. Severe swelling of genitals to include orchitis. Within 10 days sever aggravation of pre-existing arthritis in knees.
Tested positive for covid -19; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of CORONAVIRUS TEST POSITIVE (Tested positive for covid -19) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced CORONAVIRUS TEST POSITIVE (Tested positive for covid -19). At the time of the report, CORONAVIRUS TEST POSITIVE (Tested positive for covid -19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Feb-2021, Coronavirus test positive: positive (Positive) Positive.     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.   Concominant medication were not reported. Treatment information was not provided.
No adverse side effects were reported with the administration of the vaccine; HCP called to report a TE for VAXNEUVANCE  which was also administered to a patient; This spontaneous report was received from a medical assistant and refers to a 6-month-old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 26-JUN-2023, the patient was vaccinated with an improperly storage pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection, 0.5 milliliter, valid lot #W039033, expiration date: 01-OCT-2024, administered for prophylaxis (frequency, strength, and route of administration were not provided). Temperature excursion occurred at 49.1F for 34 minutes with two previous excursions at 35.9F for 2 minutes and again at 35.9F for 2 minutes. No adverse side effects were reported with the administration of the vaccine.
pt recv vax 2JAN98 & LMP 1DEC97 & EDD is 7SEP98;pt had a D&C on 20FEB98 11wk of gestation, for a spontaneous miscarriage;it was reported that analysis of the products of conception did not ID any gross anomaly;
Vasovagal response.  Skin color became pale, white lips, but was still able to speak with family and nurses. Pt was shaking, diaphoretic, and rap pulse on assessment. Pt stated, "my ears started ringing, bad pain in my left arm, things got dark, and remembering sitting on the floor when I came to." 911 was called. After deep breathing exercises and cool compresses pt slowed breathing, pinks became pink, and blood pressure/HR came back in normal range for his age. O2 sats were 98%.
Extreme swelling of left arm with redness from shoulder to elbow, warmth and tenderness. Minimal soreness.
Information has been received from a physician via company employees and a practice manager referring to a patient of unknown age and gender. On 01-MAR-2016 the patient was vaccinated with an improperly stored dose of M-M-R II (rHA (recombinant human albumin), lot #L003856, expiration date 05-FEB-2017, strength, dose and route were unspecified). This specified lot number vaccine was exposed to temperature excursion twice. The total cumulative excursion time of the first time was 800 hours with the lowest recorded temperature of 34 Fahrenheit degree. The total cumulative excursion time of the second time was 168 hours with the lowest recorded temperature of 32 Fahrenheit degree. The storage criteria of this vaccine was refrigerator/freezer (R/F) and the type of excursion was refrigerator (R). No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
A serious spontaneous report of behavior change presented by hyperactive and oppositional and started exhibiting repetitive behavior, including touching his nose repeatedly, repeatedly bobbing his head and repeatedly sniffing his pants, and jumping up and down;  autism and pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS) has been received from a mother/consumer concerning her six-year-old male child, subsequent to Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal.  The patient's medical history included sinus infection for one year prior to receiving vaccine.  On 19-Oct-2009, the patient was also diagnosed with rheumatic fever and strep throat.  No concomitant medications have been reported for this patient.  On 19-Oct-2009, the patient received Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal, for an unknown indication.  On 19-Oct-2009, the patient was prescribed amoxicillin/clavulanate.  On 03-Nov-2009, the patient stopped taking amoxicillin/clavulanate and his behavior began to change.  He got hyperactive and oppositional and started exhibiting repetitive behavior, including touching his nose repeatedly, repeatedly bobbing his head and repeatedly sniffing his pants, and jumping up and down.  He was now being tested for autism and pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS).  The outcome of the events was unknown at the time of reporting.
Severe headache as well as mild chills, nausea and fatigue.  My morning just a light headache and that was gone by midafternoon