chrisvoncsefalvay/vaers-outcomes huggingface dataset:
NOT FEELING GOOD ON HER BODY; 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 2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced not feeling good on her body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of not feeling good on her body was not reported. This report was non-serious.
Information has been received from a pharmacist concerning a patient who on 15-DEC-2009 was vaccinated with an incomplete dose of PNEUMOVAX 23, IM. The vaccine leaked from the injection site during administration. No adverse effects were reported. Additional information has been requested.
This spontaneous report as received from a physician via company representatives and from a support services director, refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 27-MAY-2014, the patient was vaccinated with a dose of improperly stored PNEUMOVAX 23 lot number K003074 with expiration date of 13-MAR-2015 (route of administration and anatomical location were unknown). The sum of hours of the vaccine excursion was 624 hours and the lowest recorded temperature reported as 33 degrees F (0.555555556 Celsius degrees). The storage criteria and the storage type were reported as "Refrigerator(R)". The vaccine status was reported as "in excursion". No adverse effect were reported. No product quality complaint was involved. This is one of several cases from the same reporter. Additional information has been requested.
Full dose 0.5ml was given, instead of 0.25ml to the patient. Clinic monitored patient, no adverse side effects reported or observed. Patient is fit for full-duty.
Information has been received from a registered nurse referring to an unknown number of patients of unknown age and gender. The patient's medical history and concurrent conditions were not provided. On unspecified dates the patients were vaccinated with GARDASIL (dosage, strength, route and lot # were not reported), which had been improperly stored. At the time of the report, no adverse effects were reported. This is one of several report from the same reporter. Additional information is not expected as the reporter did not wish further contact.
This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA (Flu), COVID-19 (Tested positive for COVID), FEELING ABNORMAL ( feeling bad), MALAISE (feeling sick) and CHILLS (Started having chills) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.). Concomitant products included INFLIXIMAB (REMICADE), LOPERAMIDE HYDROCHLORIDE (IMODIUM) and ACYCLOVIR [ACICLOVIR] for an unknown indication.    On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Dec-2020, the patient experienced INFLUENZA (Flu) and MALAISE (feeling sick). On 26-Dec-2020, the patient experienced FEELING ABNORMAL ( feeling bad) and CHILLS (Started having chills). On 29-Dec-2020, the patient experienced COVID-19 (Tested positive for COVID). At the time of the report, INFLUENZA (Flu), COVID-19 (Tested positive for COVID), FEELING ABNORMAL ( feeling bad), MALAISE (feeling sick) and CHILLS (Started having chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Dec-2020, COVID-19: 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.; Sender's Comments: Based on biological implausibility the event of COVID-19 infection is assessed as unlikely related to mRNA-1273.  Based on the current available information and temporal association between the use of the product and the start date of the events of flu like, chills, general malaise, a causal relationship cannot be excluded."
Myalgia, Fever, lymphadenopathy Narrative: Patient visited emergency department on 1/31 due to concern about 4"x4 areas of painful swelling in Right axilla. Ultrasound findings were non- concerning. Swelling less painful and reducing over next several days.  Other Relevant History:
Patient came to pharmacy 5 days after immunization, she presented with a red mark with swelling at the site of injection. When I spoke with patient today, she stated that the doctor told her to apply ice to the spot. She stated that she is doing fine and the swelling and red mark is almost gone.
24 y/o WM ADSM is referred from the HMJF Anthrax research study site for evaluation of local reaction after AVA # 2.  Symptoms:  Edema at injection site 50-120mm, Pain.
Moderna COVID-19 Vaccine EUA Redness and hardness at injection site. Also itchy. Still experiencing after almost two weeks.
9-16-12: Raspberry red rash size of silver dollar at injection site (no pain/itch). Redness surrounding raspberry rash extending over back of arm down to elbow. 9-18-12: Rash improving and starting to fade.
This case was reported by a pharmacist via sales rep and described the occurrence of chills in an unspecified number of adult patients who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills. On an unknown date, the outcome of the chills was unknown. It was unknown if the reporter considered the chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The pharmacist reported that they heard reports of severe chills after administration of GlaxoSmithKline shingles vaccine. The reporter wanted to know if the GlaxoSmithKline was aware of these reports and also wanted to know if there are any premedication or post-injection recommendations available to avoid this adverse event.
This spontaneous report as received from a nurse refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reaction/allergies and concomitant medications were not reported. On an unknown date the patient was vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (lot # M024683 and expiry date 18-MAY-2018), subcutaneously. No adverse effects were reported. The vaccine was exposed to temperature excursion of 30.4 Fahrenheit for 6 hours. Digital data logger was involved. No previous temperature excursion was reported. No product quality complaint was filed. Additional information has been requested.
Became incredibly ill on March 4, 2021, still sick, fluctuating fevers 100-104, body aches, dizzyness, weakness, unbalanced, sweating, unable to get out of bed to days, almost passed out on March 6th.  Day 7, dizzy head, dry mouth, recent tickle cough at back of tongue making it hard to breathe or talk without coughing spasm,  slightly more strength today, but still feel incredibly weak and don't know how long to get back my normal self.  No congestion or lung problems.
Adverse allergic reaction across face, arms, hands and rectum; severe nausea; vomiting; inflammation in colitis; inflammation in colitis; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 37-year-old female patient received BNT162b2 (COMIRNATY, Lot/batch number: ER8733, expiry date: not reported, Age at vaccination: 37-year-old) via an unspecified route of administration in left arm on 02Apr2021 12:00 AM as DOSE 1, SINGLE for COVID-19 immunisation. Patient medical history included allergy from amoxicillin. The concomitant medications were not reported. On 02Apr2021, patient experienced adverse allergic reaction across face, arms, hands and rectum, severe nausea, vomiting, inflammation in colitis (Inflammation and colitis). Treatment was received as antibiotic (Augmentin) for adverse event. No other vaccine in four weeks. Adverse event resulted in doctor or other healthcare professional office/clinic visit. No COVID present prior vaccination. COVID was not tested post vaccination.  No follow-up attempts are possible. No further information is expected.
10:45 AM Sudden onset 5 min after receiving Trivalent vaccine in (L) arm. Felt numbness on (R) side of face and arm. Very anxious. Denies any SOB, swelling of throat, no hives. 11 AM Advised to physician today.
Received Expired Vaccine beyond the manufacturer's expiration date-3rd patient 10MAY2022/Two patients each received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a physician assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine beyond the manufacturer's expiration date-3rd patient 10MAY2022/Two patients each received expired Moderna Covid-19 vaccine) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 016J21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 10-May-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine beyond the manufacturer's expiration date-3rd patient 10MAY2022/Two patients each received expired Moderna Covid-19 vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received Expired Vaccine beyond the manufacturer's expiration date-3rd patient 10MAY2022/Two patients each received expired Moderna Covid-19 vaccine) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Reporter stated that two patients received Moderna Covid-19 vaccine which was expired. Date the vial was initially stored in the refrigerator was 13-APR-2022. The vial did not undergo any temperature excursions. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2022: Live Followup included primary and secondary reporter details and the date of vial was initially stored in the refrigerator was updated.
Child became pale, lost vision, light headed diaphoretic. Child was asked to be down vs checked, given some juice and recovered.
Muscle and joint weakness and pain Diarrhea  Stomach cramps  Nausea
Information has been received from a registered nurse concerning a 38 month old male (also reported from registered nurse as female) with bilateral otitis media at the time of vaccination, asthma, and no known allergies and a history of hand surgery and tympanostomy tube placement. On 12/08/1998 the pt was vaccinated with the first dose of varicella vaccine IM in the left thigh. Concomitant therapy included albuteral. On 03/15/2001 the pt was diagnosed with chicken pox. The pt had one lesion on the tonsil area, a few on the legs and trunk, and a number on the face. On 03/21/2001 the pt recovered. It was noted that the pt did not have an adverse reaction following a prior vaccination. No further info is expected.
lt leg w/redness & swelling where vax was put;better today & is improving;advised to put warm, moist compress;
Patient reported approximately 6 hours after vaccination she started to feel sick, lethargic, runny nose and sneezing. Patient stated that her skin begin to hurt to the touch. She had pain on the left side of her body in the back, ribs and pain goes from back to front and is more prominent in the back. Patient stated that her lungs felt compromised.
Information has been received from a licensed practical nurse concerning a 5 year old female with eczema on buttocks and no known drug reactions/allergies who on 07-MAY-2008 at 12:29PM was vaccinated subcutaneous in left arm with a 0.5 ml first dose of  VARIVAX (Oka/Merck) (Lot# 647090/0883N) and on 02-MAY-2008 at 12:20PM was vaccinated subcutaneous in left arm with a 0.5 ml second dose of  VARIVAX (Oka/Merck) (LOT# 659169/1500U). Concomitant therapy included IPOL (LOT# A03422), DAPTACEL (LOT# C2950AA), HAVRIX (LOT# AHAVB256BA) and MMR II (MSD) (LOT# 656616/0871U). The patient developed a reaction less than two minutes after vaccinated with  VARIVAX (Oka/Merck) on 02-MAY-2008. The reaction was described as a 11cm red rash on the upper left deltoid, a 2cm x 2cm welt on the left arm (posterior of the injection site) and another welt on the anterior left deltoid. The patient was given one teaspoonful of BENADRYL. The patient did not experience a reaction after the first dose of  VARIVAX (Oka/Merck) on 07-May-2007. The patient sought medical attention at the physician's office and there was no product quality complaint. Subsequently, the patient recovered from the rash and welt on the left arm. Additional information is not expected.
It started with a postnasal drip and a slight sore throat only in my right nostril and the right side of my throat which lasted about 3 days. I also had a slight fever and cough.
(R) arm sore - next day - increased pain 9/25 / 7 AM - chills - difficulty with grip strength - afternoon 99.8 Temp. at 6:30 - feeling feverish, nauseated. Hard to move (R) arm. 9-27 - feeling much better. 10/1 - still hot with small knot. Rash 9/25/12 $ size below injection site. Hot to touch.
Fever ranging from 100.4 to 101.8 for 24 hours continuously - no cycling. Began morning after shot. Flu-like aches in arms, legs and hips for about 1.5 days Red rash about size of tennis ball around injection site on 2nd day by third day spread down upper arm. Swollen supraclavicular lymph node 2nd day by third day entire clavicle area on left side swollen and puffy. Arm and clavicle area warm to touch and red still present on Saturday 4/10/2021 at time of filling out this form Headache -2 days after vaccine
I felt terribly sick, just as if I was having Covid-19 all over again; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (I felt terribly sick, just as if I was having Covid-19 all over again) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (about 2 and a half years ago).   On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ILLNESS (I felt terribly sick, just as if I was having Covid-19 all over again). At the time of the report, ILLNESS (I felt terribly sick, just as if I was having Covid-19 all over again) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ILLNESS (I felt terribly sick, just as if I was having Covid-19 all over again) to be related.    No concomitant medication was reported.  It was reported that patient feel very sick every time get a shot ,was homebound and sick. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-735436 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-735436:Bivalent Case
Rash, hardness of muscle, heat, and itching at the injection site. Headache, possibly unrelated
Tinnitus started since first dose on 9 April 2021; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Apr2021 (at the age of 36-years-old) and also received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 30Apr2021 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history included diabetes. The patient had no known allergies. Concomitant medications included ertugliflozin pidolate (STEGLATRO), metformin (MANUFACTURER UNKNOWN), atorvastatin (MANUFACTURER UNKNOWN), enalapril (MANUFACTURER UNKNOWN) and glibenclamide (GLYBURIDE); all for unknown indications from unknown dates and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021, the patient experienced tinnitus which started since the first dose. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event tinnitus which started since the first dose was not resolved at the time of the report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient began to complain of chills, fever to 102 degrees, nausea & vomiting a few hours after vaccination. Went to local ER where patient required IV fluids for hypotension.
approx 3yrs p/vax pt lab tests revealed pt failed to seroconvert
Experienced tightness/discomfort across front of chest from shoulder to shoulder as 7 on a scale of 1 (no pain) to  10 (worst pain/discomfort), increased  heart rate, general discomfort, definitely felt something was seriously 'off' and didn't feel like myself...serious enough that I thought about going to ER if pain/discomfort approached 8 or 9.
Just a little pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Just a little pain in the injection site) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   The patient's past medical history included COVID-19 (discharged on 25-Mar-2021) on 12-Mar-2021. Concurrent medical conditions included Diabetes.  On 09-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Apr-2021, the patient experienced VACCINATION SITE PAIN (Just a little pain in the injection site). On 12-Apr-2021, VACCINATION SITE PAIN (Just a little pain in the injection site) had resolved.   DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Mar-2021, SARS-CoV-2 test: positive (Positive) COVID-19 positive.   mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.    Concomitant medications included unspecified medicines for diabetes. The patient did not receive any treatment medications.  This case was linked to MOD-2021-143359, MOD-2021-143384 (Patient Link).  Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: NNI.
Swelling across arm, spreading from injection site across and down multiple inches. Warmness, and muscle aches, unable to move arm without pain. Color was dark red.
congestion; mild sore throat; not feeling well; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 22Mar2021 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 22Mar2021, outcome "not recovered", described as "mild sore throat"; MALAISE (non-serious) with onset 22Mar2021, outcome "not recovered", described as "not feeling well"; ILL-DEFINED DISORDER (non-serious) with onset 25Mar2021, outcome "not recovered", described as "congestion". Therapeutic measures were not taken as a result of oropharyngeal pain, malaise, ill-defined disorder.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Face seemed to be numb an hour after shot for about 2 hrs and then face started to feel normal, also a mild headache at the time which went away as face started feeling better. Hands also became very red and hot.
First three days after shot severe left arm pain and Mild headache, 6/28 severe headache , 6/29 severe headache and mild neck and ear pain on left side, evening - 6/30  phn pain, face, neck (level 10), 7/1 phn pain continues (level 7.)
LEFT INDEX FINGER AND RIGHT RING FINGER - BOTH JUST FROZE IN PLACE. LIKD TRIGGER FINGER. SOME PAIN  (OFF AND ON FOR 6 MONTHS)
Fever; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 9 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 15:00 (Batch/Lot number: unknown) at the age of 9 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: PYREXIA (non-serious) with onset 12Nov2021 15:00, outcome "unknown", described as "Fever". Therapeutic measures were not taken as a result of pyrexia.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (16Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
6/12 830 pm patient experienced fever + chills lasted over night then starting 3 AM on 6/13 patient had diarrhea. Diarrhea lasted 3 days despite taking immodium over the counter
A serious spontaneous report of Myasthenia Gravis manifested by exacerbation of droopy eyes and muscle weakness has been received from a parent/consumer concerning a seven-year-old male child, subsequent to H1N1, intranasal. At the time of the event, the patient had droopy eyes and muscle weakness. On 11-Dec-2009, the patient received H1N1, intranasal, for an unknown indication. After receiving H1N1 LAIV, his symptoms of droopy eyes and muscle weakness were exacerbated. In Feb-2010, it was found that patient had Myasthenia Gravis. The outcome for the reported adverse event was unknown at the time of reporting.
Information has been received from a nurse practitioner concerning an adult pt (age and gender not reported) with an unk medical history and unk allergies who on 27Oct05 was vaccinated IM with a 0.5mL dose of pneumococcal 23v polysaccharide vaccine (651524/0605R). Subsequently, the pt developed an injection site reaction including swelling, redness, pain and local heat. The pt was reported as recovering. There was no product quality complaint involved. Additional information has been requested.
PATIENT REC'D PEDIARIX#3 AND HIB#3 TYLENOL GIVEN IMMEDIATELY PRIOR AND EVERY FOUR HOURS AFTER. PATIENT DEVELOPED FEVER UP TO 103F. FEVER LASTED OFF AND ON 3-4 DAYS. IRRITABLE BUT CONSOLABLE 4 DAYS. REFUSED SOLIDS FOR 3 DAYS. INTERRUPTED SLEEP FOR GREATER THAN ONE WEEK.  PREVIOUS DOSES OF PEDIARIX AND HIB AT 2 & 4 MONTHS SAME REACTIONS BUT NOT AS SEVERE AND DURATION SOME WHAT SHORTER. ALSO, PATIENT REC'D ENGERIX-B AT BIRTH. HAS HAD TOTAL OF 4 DOSES OF HEP-B.
10 x 8 cm area erythema, swelling and induration at injection site (left deltoid). 6 cm x 6 cm area erythema at left forearm. Treatment -MEDROL dose pack, BENADRYL.
Patient received Janssen on 04/09/21. On 07/28/21 & 08/18/21 the patient received a dose of Pfizer on each of those dates. No adverse events were noted.