chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Bradycardia; chest tightness; Dry mouth; sandy eye sensation; This case was received on 20-Apr-2021 and was forwarded to Moderna on 20-Apr-2021.    This regulatory authority case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of BRADYCARDIA (Bradycardia), CHEST DISCOMFORT (chest tightness), DRY MOUTH (Dry mouth) and FOREIGN BODY SENSATION IN EYES (sandy eye sensation) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L-20A) for COVID-19 vaccination.     Concurrent medical conditions included Hyperbaric oxygen therapy, Renal stone and Drug allergy. Concomitant products included METOPROLOL TARTRATE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced BRADYCARDIA (Bradycardia) (seriousness criterion medically significant), CHEST DISCOMFORT (chest tightness) (seriousness criterion medically significant) and DRY MOUTH (Dry mouth) (seriousness criterion medically significant). 14-Jan-2021, the patient experienced FOREIGN BODY SENSATION IN EYES (sandy eye sensation) (seriousness criterion medically significant). At the time of the report, BRADYCARDIA (Bradycardia), CHEST DISCOMFORT (chest tightness) and DRY MOUTH (Dry mouth) had resolved and FOREIGN BODY SENSATION IN EYES (sandy eye sensation) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Jan-2021, Activated partial thromboplastin time: normal (normal) normal. On 14-Jan-2021, Blood gases: normal (normal) normal. On 14-Jan-2021, Chest X-ray: normal (normal) normal. On 14-Jan-2021, Electrocardiogram: normal (normal) normal. On 14-Jan-2021, Full blood count: normal (normal) normal. On 14-Jan-2021, Metabolic function test: normal (normal) normal.     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.   No treatment information was provided.  Company comment: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.; Sender'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.
This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information regarding relevant medical history and concurrent condition were not reported. On 11-NOV-2015 the patient was vaccinated with MMRII (lot # L012479, expiration date 10-APR-2017, dose and route not reported), which was exposed to temperatures outside of the recommended temperature. No adverse experience had been reported. This is one of several reports received from the same source. Additional information has been requested.
Patient presented to urgent care with redness and swelling on her left arm 48 hours after receiving Fluad and Shingrix.  Her provider diagnosed her with cellulitis and prescribed doxycycline 100mg tablet. Take one tablet by mouth twice daily for 10 days.
Client received #2 Hep B vaccine on 03/14/2002 IM right deltoid area. On 03/15/2002 client reported to nurse. Client had 5cm hematoma at site of injection. Sent to Ed, advised to apply ice. Final impression is possible allergic reaction to hep b.
Developed fever 101 degrees at 11:45 PM Used Tylenol  - woke up next morning fever mostly gone but feeling tired and sore arm
This spontaneous report as received from a pharmacist refers to a patient of unknown age and unknown gender. Pertinent medical history, drug reactions or allergies were not reported. On 20-OCT-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous (dose, dose number, route, anatomical location, lot number and expiration date were unspecified), that was improperly exposed to 33.3F for 51 hours. No known adverse effects were reported. No concomitant therapies were reported. The outcome of the events was unknown. Additional information has been requested.
Received Td vaccine in Left arm/deltoid on 8/3/04. c/o redness/swelling of left deltoid 8/6/04. Redness/swelling approx 3" wide x 4" high. Also itching at injection site.
This is a spontaneous report received from a contactable consumer or other non-HCP, for a Pfizer sponsored program (003110). A patient (no qualifiers provided) received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Mar 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), for COVID-19 immunisation. The patient experienced fatigue (we are still having fatigue), with outcome of not recovered; and felt abnormal (can't hardly keep our eyes open), with outcome of unknown. Additional information: Reportedly, 3 patients received the second COVID-19 shot in March. They were still having fatigue. They wanted to know whether long-term fatigue was a side effect of the Pfizer vaccination. Some days they can't hardly keep their eyes open. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected. Sender's comments: Linked reports: US-PFIZER INC-202101155279 same reporter/AE/SD, different patient; US-PFIZER INC-202101155417 same reporter/AE/SD, different patient.
pediatric dose given to adult patient; pediatric dose given to adult patient; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 33-year-old male patient who received HBV (Engerix B 10 mcg) (batch number 25N39, expiry date 16th March 2024) for prophylaxis.   On 19th July 2022, the patient received Engerix B 10 mcg 10 ug. On 19th July 2022, unknown after receiving Engerix B 10 mcg, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.  Additional Information: GSK Receipt Date: 17-JAN-2023 Reporter's Comments: The pharmacist reported pediatric dose given to adult patient. Adverse event contained all reported information.  The reporter consented to follow up.  Additional Supportive Information: The adult patient received Engerix B pediatric dose, which led to underdose and adult use of a child product.
Pt admitted on 8/31/2021: 48-year-old female presents to the emergency room with worsening shortness of breath fever and cough.  Patient was diagnosed with COVID on 08/18/2021.  Although she seems to be somewhat in denial of this.  She had a positive test on that date.  Tonight she presents and says she just has an upper respiratory infection.  She is hypoxic on presentation.  Her COVID swab is positive tonight.  Chest x-ray is consistent COVID.  She denies any diarrhea or GI symptoms.  The patient has a history of a median sternotomy in February of 2017.  This apparently was for a thymoma.  She also has a history of lupus which apparently has not been treated since 2001.  Patient has a generalized alopecia which I assume is an autoimmune alopecia.  Patient states that she takes no medications regularly currently.  Patient states that she received 2 doses of COVID vaccine although she does not specify which brand in February of this year.  She has not had monoclonal antibody therapy with her current illness.   Pt is a current patient at the facility.
The same day as vax the pt experienced chills and fever. 15 days post vax the pt developed greater than 50 vesicles on face, abdomen, arm and at injection site accompanied by a 2 cm injection site induration.
p/vax pt devel a low grade fever, eyes were droopy, sleepy & lethargic;pt seen by MD & dx by MD w/bilat ptosis, sl full fontanelle & head tilt;pt was immed referred to neuro for MRI;results determined ATT lt hemisphere cerebellum;sz;
AFib incident 2 days after shot.  Since receiving vaccine, have had sporadic  AFib
On May 12, 2021, a small, rash-like spot appeared on my left hip. By June 2, 2021, my entire torso, legs, and arms were covered in a very itchy rash. I went to my doctor at local Family Health. He prescribed an antibiotic, which had no effect. I went back to the doctor about two weeks later and he prescribed a steroid, which had no effect. I was then referred to a local dermatologist. The rash was diagnosed as Pityriasis Rosea. The rash lasted for 12 weeks and was incredibly itchy.  My body still remains pigmented from all the little rash spots.
Woke up from sleep with extreme pain in lower right back-felt like a knot in a muscle. Pain lasted 3 hrs. Went into mild shock, felt nauseous light-headed. Could not stand. Felt very cold. Symptoms resolved-kidney stone suspected. Some blood in urine.
Critical Limb Ischemia  Symptoms: Progressive BL lower extremity and back pain starting on 3/20/2021. She presented to the ED twice and DVT ultrasound and lumbar spine CT showed no acute findings. Symptoms progressed to the point of severe pain on 4/1/2021 with toe numbness and paralysis. CTA of BL lower extremities was performed showing bilateral arterial thrombus. She underwent bilateral common femoral artery thromboembolectomy with vascular surgery. Of note, patient was on eliquis 5 mg BID given history of PE in 2018. She was compliant with this medication.
Pt was found to be having stroke like symptoms 3/15 in the morning at nursing home.  he was evaluated and was transported by ambulance from one hospital to another hospital as the CT scanner was down.  patient had an injury on march 1 with a cabinet falling on him breaking his femur and family not sure if at that time he had hit his head.  Patient was intubated in the ER CT scan showed a massive cerebral bleed with midline shift and transtentorial herniation
p/vax devel recurrence of seizures, x3; fever; cellulitis of inj site; runny nose; fussy; seizures on phenobarb; dec HR on apnea monitor (dec setting 70);arm shaking;if sz continue would f/u w/neuro sooner; has appt
RECIEVED THE VACCINE ON A FRIDAY IN THE MORNING, BY 4PM THAT DAY SHE NOTICED SHE HAD A HEADACHE  AND FELT THAT SHE HAD CHILLS AND FELT COLD, BUT DID NOT REGISTER WITH A TEMPERATURE WITH THE THERMOMETER WE USE TO SCAN STAFF WHEN THEY LEAVE FOR THE DAY.  NOTED ON SATURDAY WHEN SHE WOKE UP THAT SHE FELT VERY EXTREMLY TIRED AND WIPED OUT, AS IF SHE HAD NOT SLEPT AT ALL. WAS VERY TIRED, AND AS GOT UP TO TAKE A SHOWER SHE EXPERIENCED DIZZINESS, VERTIGO, AND FELT NAUSEUS. THIS WAS ALL EXPERIENCED ON 12/19/2020 AT 5 AM. SHE DECIDED NOT TO SHOWER BECAUSE OF HOW BAD SHE FELT, BUT DID COME ON IN TO WORK ANYWAY, AND NOTED SHE FELT TIRED ALL DAY AFTERWARDS. SHE DID NOTICE REDNESS, HEAT AND SWELLING WITH A RAISED AREA AND REDNESS  AT THE INJECTION SITE. SHE DIDN'T THINK ABOUT THIS BEING RELATED TO THE VACCINE, UNTIL THIS MORNING WHEN WE WERE TALKING ABOUT THE  VACCINE AT THE NURSING DESK, SHE NOTED SHE WAS VERY SICK IN JANUARY, AND WAS WONDERING IF SHE COULD HAVE BEEN EXPOSED TO OR HAD THE COVID VIRUS BEFORE IT WAS DETECTED IN THE UNITED STATES, SO THIS COULD BE WHY THE VACCINE MADE HER FEEL SO VERY SICK. AFTER HEARING THIS INFORMATION, WHICH WE CANNOT CORRELLATE WITH A HISTORY OF BEING EXPOSED TO COVID, I FELT SHOULD BE DOCUMENTED AND SENT IN TO VAERS JUST IN CASE WE CAN CORRELLATE THIS REACTION IN THE FUTURE
Reddened area 6" minimal inflammation. TX: Benadryl and cold compresses.
4JUN red area raised rt arm size of quarter cont to enlarge;lump @ site;
Case number PHEH2016US025936, is an initial spontaneous report received from a nurse on 04 Oct 2016. This report refers to a 90 year old male patient. Medical history and concomitant medication was not reported. The patient was vaccinated with single dose of FLUVIRIN (batch number: 1517601) at a dose of 0.5 ml intramuscularly on 04 Oct 2016. The patient was administered expired vaccine. The nurse reported that, there was no adverse event but the FLUVIRIN dose administered was out of date. No adverse event was reported following this maladministration (expired product administered). Follow up report received from a nurse on 02 Nov 2016: Updated nurse comments.
Generalized, red, lacy, macular, rash on her body. It was on her face, trunk and back. While examining her, the rash dissipated and went away. Heart and lung sounds were normal, no wheezing or increased work of breathing noted. RN was asked to give 1 mg/kg/dose of Benadryl. Parents were asked to call back if the child has any rash, or other reaction tonight or at any point over the next few days.
After shot #1 headache, fatigue sore injection site on day one diminished after 2 days. after shot 2: headache , fatigue, chills  sore injection site on day one diminished after 2 days, upper arm rash (Moderna arm) diminished after 5 days started on  day  after shot #2  muscle soreness and fatigue started on day 8 after shot #2 continues on day 11 after shot 2. No treatment other than multivitamin, vitamin c, sambucol,  vitamin A and beta carotene, and aleve
Weakness and loss of range of motion in right arm. Numbness in fingertips. Constant pain in right arm.
Patient complained of tongue tingling 45 mins post vaccine administration 11:02am .  Benadryl 25mg oral liquid administered.  Patient VS stable and no other sx reported.  Patient left walking without any symptoms of illness.
Patient passed out 24 hours after vaccination. Dose 2 of Moderna. She has recovered from the event and no additional treatment was necessary.
Patient reporting chills, shivers, headache within 1- 1.5 hours after vaccinations.  Patient put on more clothing and lay in bed.  After 3 hours later, patient is feeling much better.
This medically confirmed report (initial receipt 20-Jun-2012) concerns a 13-year-old female patient. The patient received influenza vaccine (manufacturer and batch number not specified). After the vaccination she developed Bell's palsy. She was seen by many specialists. The event outcome was not yet recovered.
pt has a history of fainting almost every time she has a needle stick ,  she did again.  Patient was faint and light headed for 20-30 minutes at 30 minutes her bp was 96/69  63 pulse.  she left on her own feet with mother at her side.
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 22-APR-2015, the patient was vaccinated with the first dose of GARDASIL injection, lot# L001442 and expiration date 30-NOV-2016; exact dose and route of administration were not reported. On 30-JUN-2015, the patient received a second dose of GARDASIL injection (lot reported as L007495 and expiration date: 28-FEB-2017; exact dose and route of administration were not reported). On 03-NOV-2015, the patient received the first dose of GARDASIL 9 injection (lot# L019286 and expiration date: 30-SEP-2017; exact dose and route of administration were not reported). On 04-JAN-2016, the patient received the second dose of GARDASIL 9 injection (lot reported as  L077282 and expiration date: 30-SEP-2017; exact dose and route of administration were not reported). On 05-DEC-2016, the patient received the third dose of GARDASIL 9 injection (lot# M031557 and expiration date: 30-APR-2019; exact dose and route of administration were not reported). No adverse effects were reported. The reporter provided GARDASIL with lot# L004795, which was not valid for GARDASIL. However, lot# L007495 is valid for GARDASIL 9. Lot number L077282 is an invalid lot number for GARDASIL 9. Additional information has been requested.
SHORTNESS OF BREATH; FULL BODY ACHE; JOINTS HURT; SEVERE HEADACHE; NAUSEA; SENSITIVITY TO LIGHT; LETHARGIC; This spontaneous report received from a consumer concerned a 47 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A, and expiry: UNKNOWN) dose was not reported, administered on 01-APR-2021 15:25 for prophylactic vaccination. Concomitant medications included benzylpenicillin for drug used for unknown indication. On APR-2021, the subject experienced lethargic. On 02-APR-2021, the subject experienced sensitivity to light. On 02-APR-2021, the subject experienced nausea. On 02-APR-2021 01:15, the subject experienced shortness of breath. On 02-APR-2021 01:15, the subject experienced full body ache. On 02-APR-2021 01:15, the subject experienced joints hurt. On 02-APR-2021 01:15, the subject experienced severe headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from shortness of breath, full body ache, and severe headache on 03-APR-2021 09:35, had not recovered from lethargic, and the outcome of joints hurt, nausea and sensitivity to light was not reported. This report was non-serious.; Sender's Comments: V0: Medical assessment comment not required as per standard procedure as case assessed as non-serious.
pt recv vax & approx 1hr p/vax pt exp erythema & swelling @ inj site;This is 1 of 3 patients, who exp same rxn w/the same lot#
I went to my OBGYN 9/15/21 for my first ultrasound which I should've been around 10 weeks pregnant where they were not able to find a heartbeat.  The baby was only measuring about 8.5 weeks along in size which was when I felt symptoms drop off.  I have one healthy 3 year old and this was my first miscarriage along with two of my sister-in-laws which we are all vaccinated and conceived around the same time.  I didn't miscarry on my own but took medicine that night to speed along the process.   I was also asking the doctor about a significant amount of hair loss I was having before the miscarriage which seems to have slowed down but to me is a very noticeable difference.
Information has been received from a physician concerning a patient (age and sex not reported) who on unspecified dates was vaccinated with the first and second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (Lot # not provided). It was reported that it had been 11 weeks since the second dose and the third dose had not yet been administered. No symptoms have been reported. Additional information has been requested
p/vax pt exp redness; swelling & heat at lt arm inj site; rx: rest; DPH; anticipate recovery
LITTLE BIT SICK; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced little bit sick. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of little bit sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20211212233.
Pt recvd vax & became jaundiced & devel hepatitis; No further details were provided;
"mumps" type illness 2 days > vaccine, "measles" type illness 4 days > vaccine. T max 101 morbilliformal rash "crankiness.
Anaphylactic reaction; A spontaneous report was received from a 62-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic reaction.  The patient's medical history, as reported, included 4 previous anaphylactic reactions since she was 9 years old, history of throat problems and swelling, bronchitis, and her brother died in 1997 due to an anaphylactic reaction to poison ivy and bee stings. Concomitant medications reported included thyroid medication (not specified), blood pressure medication (not specified), gabapentin, sleep medicine (not specified) and curcuma longa rhizome.  On 24 Jan 2021, about 15 minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 24 Jan 2021, 30 minutes prior to receiving the vaccine, the patient took prednisone (dose unknown), per instructions from her doctor due to her history of anaphylactic reactions. She did notify the vaccinators of her history and there was an ambulance present. About 15 minutes after receiving the vaccine, the patient started coughing, had heavy chest pain, trouble breathing, and felt like her throat was constricting more than usual. No rash developed. She approached the ambulance and asked if she could take diphenhydramine. She took one dose, followed by 3 other doses, and felt a bit better. Consent given for Safety to follow up with patient.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event, anaphylactic reaction was resolving at the time of this report.; Reporter's Comments: This case concerns a 62 year old female patient with medical history of included 4 previous anaphylactic reactions since she was 9 years old, history of throat problems and swelling, bronchitis, and her brother died in 1997 due to an anaphylactic reaction to poison ivy and bee stings. Concomitant medications reported included thyroid medication (not specified), blood pressure medication (not specified), gabapentin, sleep medicine (not specified) and curcuma longa rhizome. She experienced a serious unexpected event of Anaphylactic reaction that needed treatment diphenhydramine. The event occurred approximately 15 minutes after first dose of the study medication administration even thought the patient took prednisone prior to receiving the vaccine. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Severe left foot & leg drop  (I can barely walk), extreme left arm numbness, bladder incontinence ( I can't hold my bladder), extreme fatigue.  All these symptoms lasted approx. 9 days and the left foot & leg drop did not come back to what it was before. I'd say it came back approx. 90% to how it was before.
Rash all over body. Some itching around the neck area, prescribed with Rx Diphenhydramine HCl 12.5 mg/5 mL - Give 3 mL PO every 8 hrs as needed for itch.
pt recv vax 6PM & that same evening began this weird constant crying like never heard a/or since;It went on for hr & hr && felt it would never end;
BACK ACHE; neck pain; 99F and is feeling feverish; feels fatigued; myalgia; This spontaneous report was received from a physician via Pfizer, and referred to himself, a male of unknown age. The patient's concurrent conditions and concomitant therapies were not reported. He received pneumococcal vaccine conj 13v (crm197) (PREVNAR 13) years ago (as reported).  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis (strength, dose, lot #, expiry date, and route of administration were not provided).  3 or 4 days after the vaccination, he started to experience an ache in his back and neck and it had continued for 8 days. He normally had a body temperature of 97F, however after the vaccination he had ran a 99F and was feeling feverish. He also felt fatigued and had myalgia that did not go away until he took ibuprofen (ADVIL). The outcome of all the events was not reported.  The causal relationship between all the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.