chrisvoncsefalvay/vaers-outcomes huggingface dataset:
diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhoea) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included PEMBROLIZUMAB (KEYTRUDA), LEVOTHYROXINE, BIOTIN, CALCIUM, OMEPRAZOLE, CYANOCOBALAMIN (VITAMIN B-12), MAGNESIUM, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), IRON, ASCORBIC ACID, VACCINIUM MACROCARPON (CRANBERRY + C), TOPIRAMATE, ESCITALOPRAM, ZOLPIDEM, NARATRIPTAN, NAPROXEN and ONDANSETRON (ZOFRAN MELT) for an unknown indication.    On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (diarrhoea). The patient was treated with PREDNISONE at a dose of 40 mg. At the time of the report, DIARRHOEA (diarrhoea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-078150 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-078150:second dose case
Sleep pattern is off, get 4 hours a night,  Daily headaches after waking up, keeping forgetting or losing things, all symptoms started week after #2, 10/7 migraine all day, with pain from my left side temple, down my neck to my shoulder, 10/8 woke up with same migraine (maxalt prescribed not working) last all day, woke up at midnight trowing up every 30 ins to and hour until 4 am. no appetite and migraine still here
a lump under my left arm pit the size of a lemon and also on the left side of my neck by my shoulder; arm pain; pain got better but still has lumps there; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Dec2021 (Lot number: FJ1620) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "UTI" (unspecified if ongoing), notes: was on antibiotics for a previous UTI. The patient took concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Dec2021, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 14Dec2021, outcome "not recovered", described as "a lump under my left arm pit the size of a lemon and also on the left side of my neck by my shoulder"; PAIN IN EXTREMITY (non-serious) with onset 13Dec2021, outcome "recovering", described as "arm pain"; VACCINATION SITE PAIN (non-serious) with onset 13Dec2021, outcome "recovering", described as "pain got better but still has lumps there". Therapeutic measures were taken as a result of lymphadenopathy, pain in extremity, vaccination site pain.  Additional information: Patient stated that she had no issue with the first two doses of the vaccines, product information for first two not provided.  The patient stated that she received her Pfizer BTC vaccine (purple cap formula) booster dose on 12Dec2021 and "then on Tuesday, yesterday, she had a lump under her left arm pit  the size of a lemon and also on the left side of neck by shoulder. Caller stated this lump was soft and felt like it was fluid filled. The patient told pharmacist she had pain, was on antibiotics for a previous UTI, asked pharmacy if she could take tylenol for the pain while on the antibiotics and stated she took two Tylenol and pain got better but still has lumps there.   No follow-up attempts are possible. No further information is expected.
Pain and swelling at the place where the vaccine is injected; mild rash over body, neck, and face.
INSIDE CHILLS, FOLLOWED BY  MUSCLE VIBRATIONS. THEN ESCACATED TO CHLLS FOLLOWED BY EXTREME MUSCLE CONTRACTIONS, THEN ESCLATED TO CHILLS FOLLOWED BY LIMBS, NECK, WRISTS, FINGERS VIOLENTLY JERKING.  THE ESCLATION WAS FAST AND I COULD NOT STAND DURING THE WORST OF IT. AFTER IT EASED UP (AFTER ABOUT 3 HOURS) I AM LEFT WITH EXTREME MUSCLE SORNESS  ALL OVER MY BODY.  I WAS FRIGHTENED DURING THE EPISODE. I HAVENT BEEN TO A DOCTOR IN A FEW YEARS SO DON'T KNOW WHO TO CALL. I THINK I AM FINE NOW. IN RETROSPECT, THE NIGHT AFTER THE SHOT I SLEPT VERY RESTLESSLY AND FELT LIKE I WAS EXPERENCING "VIBRATIONS" THOUGHOUT THE NIGHT. NOW I THINK IT MUST HAVE BEEN MUSCLE CONTRACTIONS.
pt began exp coughing & swollen throat around 430PM;pt was difficult to swallow ;face/eyes swelled, pain exp in back of neck & shoulder;hard to breathe;couldn't sleep very well;very tired today;
This case was reported by a healthcare professional and described the occurrence of expired vaccine used in a 3-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline). In September 2014, the subject received an expired dose of PEDIARIX (administration site and route unknown).
Information has been received from a physician and medical assistant concerning a 20 month old male who on 24 Oct 2004 was inadvertently vaccinated with a dose of varicella zoster virus vaccine (lot #652936/0981F) instead of varicella virus vaccine live. The medical assistant did not know there were two varicella vaccines and both vaccines were stored in the same place in the refrigerator. She reported, "it was just a mistake." Unspecified medical attention was sought and no adverse event was reported. As of 07 Nov 2006, the patient was doing fine. No product quality complaint was involved. Additional information has been requested.
Vaccine use by 12/12/2021, vaccine administered 11/22/2021
Patient felt warm sensation and pain and then had pain in chest area a few days later. Patient went to doctor and was prescribed antibiotics.
Improperly stored dose of varivax; This spontaneous case was received from a pharmacy technician referring to a patient of unknown age and gender. The patient's concomitant medications included sterile diluent. The patient's pertinent medical history and drug reactions/allergies were not reported. On 27-JAN-2020, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) of lot number S024366, expiry date was reported as 02-MAR-2021 but upon internal validation it was established as 06-AUG-2021 (dose, strength and route of administration were not reported) for prophylaxis (product storage error). The lot underwent a temperature excursion at -14 degree Celsius to -10 degree Celsius for 2 hours 30 minutes and -9 degree Celsius to 8 degree Celsius for 5 hours 40 minutes. There was no previous temperature excursion. The call was placed because of a data logger. There was no product quality complaint (PQC) was present.
Mother noted the baby to have fine tremor of the head about a week ago. Mother brought baby 12/01/04. Noted flighty tremors of head 1-2 seconds. Beg alert while having the tremors. There was no fever after episode. Patient referred to Neurologist.
Cluster of vesicles left post neck and left and neck; This is a spontaneous report received from a contactable reporter(s) (Physician).  A 63 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 02Apr2021 (Lot number: ER8737) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic lymphatic leukemia" (unspecified if ongoing); "Hypercholesteremia" (unspecified if ongoing); "Chronic rhinitis" (unspecified if ongoing); "Osteopenia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BLISTER (non-serious) with onset 01May2021, outcome "unknown", described as "Cluster of vesicles left post neck and left and neck". The event "cluster of vesicles left post neck and left and neck" was evaluated at the physician office visit. Therapeutic measures were taken as a result of blister.  Additional information: No prior vaccinations within 4 weeks. Patient received treatment valacyclovir 1 gm prescription for the event. Patient was not diagnosed with Covid-19 prior to vaccination and also has not been tested for Covid-19 since the vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
AFTER ABOUT 14 HOURS, I DEVELOPED A BURNIG UNDER MY EYES IN MY SINUS CAVATIES. NEXT NIGHT AND REMAINDER OF NIGHTS, SAME PROBLEM (SLIGHTLY LESS PAIN) JUST ON LEFT SIDE OF MY FACE. EARLY THIS MORMING, THE BURNING (IRIRATION) CAME TO MY LEFT SIDE UPPERV GUM AND MY UPPER TEETH
PATIENT'S SON CALLS TO REPORT THAT HIS MOTHER IS COMPLAINING OF SEVERE SORENESS AND REDNESS/WARMTH AT INJECTION SITE.
Information has been received from a nurse concerning a 12 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided. On 13-DEC-2016, the patient was vaccinated with a dose of improperly stored GARDASIL 9 (lot # L024993, expiration date 17-OCT-2017, dose and route unspecified) for prophylaxis. The vaccines were stored at 11.6 degree Centigrade for 1 hour and 50 minutes. Data logger was involved in the case. There was previous temperature excursion at 9.3 degree Centigrade for 50 minutes. No adverse effect was reported. It was reported that the excursion involved a total of three lots of GARDASIL 9. Two lots (L024993 and M024261) were involved in the event "doses of GARDASIL 9 administered after 13-DEC-2016 temperature incident". This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1612USA008047: US-009507513-1703USA002792: US-009507513-1703USA002793: US-009507513-1703USA002795: US-009507513-1703USA002796: US-009507513-1703USA002797: US-009507513-1703USA002798: US-009507513-1703USA002799: US-009507513-1612USA007442: US-009507513-1702USA010448.
No adverse event; 47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7642B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jun-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (47 patients received the Moderna Covid-19 bivalent vaccine after the use-by date.).    No relevant concomitant medications were reported. Staff gave patients vaccines past the use date of 18 Jun 2023. On 27 Jun 2023, 3 doses were administered at administration site 2. No treatment medication reported.   This case was for the 39th patient out of 47 reported.    This case was linked to US-MODERNATX, INC.-MOD-2023-732752 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2023: Vaccine information reported and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732752:Master case
Pt. experienced vomiting after HPV immunization. Cleared and all sx resolved  in approx. 10 min. No PH vasovagal sx or immuniz rxn.
I had a really swollen, red arm. I experienced balance problems and dizziness and erratic heartbeat. More shortness of breath and my temperature changes. I had COVID-19 back in 2020 prior to the vaccine.
Vaccine administered was 2nd dose Jynneos on 9/6/2022.  (1st dose administered on 8/8/22) On 9/7/22, patient presented at Urgent care with fatigue, body aches, HA (pain level 8 out of 10), mouth sores (possibly pox), and wrist/hand weakness. Recommended swabbing of mouth sores and submit for testing. Recommended isolation to include not sexual activity. Pt to call his ID doc for appt. No known MPX exposure.
3PM fever, vomiting, diarrhea;6-7PM unresponsive per parents report;taken to ER by amb;alert & crying on admission to ER;dx fever, diarrhea;
Patient said her whole shoulder swelled at injection site and she got hives all down her arm the morning following injection.
No hx of allergies - 10-15 min after shot, (L) arm began itching, now about 1 hr after shot - spreading down back, buttocks.
This case was received from a health professional on 06 July 2007. SERIOUSNESS CRITERIA: OTHER - MEDICALLY SIGNIFICANT. A 58-year-old male patient with no known medical history had received dose two of Imovax (lot number Z09431) on 18 May 2007. For days later, on 22 May 2007, he began experiencing bizarre behavior, confusion, and "felt like he was drunk". Following administration of dose three, he experienced increased confusion within minutes of vaccination, with neck stiffness, headache, and fatigue. White blood count was 15,000. On 03 July 2007 he began a Medrol pack and noted a slight improvement until he received dose four, when he again began acting bizarre and felt as though he were "in a fog". On 06 July 2007 he saw a neurologist and was started on Prednisone. The patient had not yet recovered. The first dose of Imovax had been administered on 14 May 2007. The reporter also stated that the patient had received an unknown vaccine (Novartis) on 11 May 2007.
BLOOD PRESSURE SO HIGH; HEAD BANGING SO HARD; This spontaneous report received from a patient via a company representative concerned a 60 year old of unspecified sex. 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, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced blood pressure so high, and head banging so hard. Laboratory data (dates unspecified) included: Blood pressure so high. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from blood pressure so high, and head banging so hard. This report was non-serious.; Sender's Comments: V0: V0-Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Immune thrombocytopenia diagnosed 6/9/2021 superior sagittal sinus thrombosis. diagnosed 7/12/2021
02/23/22 presents to EC ED for "generalized weakness and fatigue". PMHx of "CKD Stage III, CAD, DMII, OSA (unable to tolerate CPAP), PAD"
fatigue; sore throat; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. A 65-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 (Lot number: EM9810) at the age of 65 years as dose 2, single for covid-19 immunization. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (dose 1, single, LOT: could be EL9261, LZ9261, LL9261), administration date: 10Feb2021, when the patient was 65 years old, for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 04Mar2021, outcome "not recovered", described as "sore throat"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". Additional information: Caller wanted to know if it was normal to experience a sore throat and fatigue after the second dose of the vaccine. No investigation assessment was done. Caller wanted to know if these events could be related to the vaccine. No follow-up attempts are possible. No further information is expected.
Received both doses of Pfizer vaccine and tested positive for covid -19; Received both doses of Pfizer vaccine and tested positive for covid -19; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), first dose (at the age of 78-years-old) via an unspecified route of administration on 26Jan2021 at 13:00 (Batch/Lot number: UNKNOWN) as a single dose and the second dose (at the age of 78-years-old) via an unspecified route of administration on 17Feb2021 at 12:00 (Batch/Lot number: UNKNOWN) as a single dose for COVID-19 immunisation. Medical history was reported as none. The patient has no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient received both doses of the Pfizer vaccine at a pharmacy/drug store and tested positive for COVID-19 on 16Mar2021 (also reported as 17Mar2021). Lab data included SAR-COV-2 test (nasal swab) was positive on 16Mar2021. No treatment was received. The outcome of vaccine failure and COVID-19 was reported as recovering.  The lot number for the vaccine was not provided and will be requested during follow up.
Persistent soreness/pain and restriction of movement since day after vaccination. Slight improvement, but no resolution.
pt recv vax 25FEB94 & exp hepatitis (date of dx not provided);
Cant lift my left arms at all, its falling and it is very painful, the moment she released the vaccines my arms is so painful and feels like it was dead and cant lift at all.
booster; Itching; Rashes/rash was everywhere/comes up red; Welts; she felt like crap; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received 3rd dose of BNT162B2 (COMIRNATY) at single dose on 05Oct2021 at 58-year-old via an unknown route in left arm for COVID-19 immunization. Medical history included ongoing Hashimoto's disease which was diagnosed 25 years ago as of 28Oct2021. Concomitant drug was not provided. Historical vaccine included 1st and 2nd dose of COVID-19 Vaccine MANUFACTURER UNKNOWN for COVID-19 immunization.  Patient received the booster dose of the Pfizer Covid 19 vaccine on 05Oct2021, and as of 28Oct2021she was still having issues with itching, rashes and welts. The itching had gotten worse. She was told to take Zyrtec until the itching stopped and that it could be a couple weeks, but it had been 3 weeks and there was no improvement. She took a prednisone shot on 28Oct2021. Patient stated like she felt like crap, but everything really started three days after the booster shot.  Patient stated that the rash was everywhere. It was further reported that "someone said that this could be like when you scratch and it comes up red, when it started welting does that mean your histamines". Outcome of the events itching, rashes/rash was everywhere/comes up red, and welts was not resolved. Outcome of the other events was unknown.     The report was assessed as non-serious. The report was not related to a study or programme.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Shaking uncontrollably at midnight and was woken up from sleeping. It lasted 30 minutes and was very scary. I received the3rd dose vaccine at 10am that morning & only my left arm hurt at 1 pm so went to bed at 10pm after taking 2 Tylenol.
Information has been received from a licensed practitioner nurse concerning an unknown number of patients of unknown age and gender. Since 19-MAR-2015 the patients were vaccinated with doses of improperly stored ROTATEQ, lot # K016261, expiration date 23-JUN-2016 (dose not reported), orally, which underwent support temperature excursions. This is one of several reports received from the same source. Additional information has been requested.
COVID19 PFIZER-BIO TECH - received Coivd vaccine 8/4/21. developed pruritic, raised vesicular rash 8/6/21 at approximately 10 am. Rash started at neck at hairline progressing rapidly to torso and upper extremities.8/9/21 pt took generic antihistamine and rash dissipating within 2 hours. note patietn started new medication (bupropion) one week prior to vaccine
This spontaneous report was received from a pharmacist refers to a 67 year old female patient. The patient's current condition included fibromyalgia and formaldehyde allergy. On 16-NOV-2012, the patient was vaccinated with a dose of 0.65 ml ZOSTAVAX, (lot number reported as 0566ae, expiration date of April-2013, route- subcutaneous). Concomitant medications reported included WELCHOL and oxycodone. On 18-NOV-2012, the patient developed a hard swollen lump at injection site two days after she received ZOSTAVAX injection. The patient reported to the pharmacy, that the swelling had spread down to her elbow. There were no lab diagnostics performed. The patient did not seek medical attention for swelling. There was no treatment rendered for the events. The outcome of the reported events were unknown at the time of this report. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Pertinent medical history, drug reactions or allergies and concurrent conditions were not reported. On 25-JUL-2016 the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # L003188 expiration date 06-JUL-2016, (Dose, route and anatomical location were not provided. No product quality complain was involved. No other suspect medications or concomitant therapies were reported. No adverse effects were reported. Additional information has been requested.
her ankle is swelling up again; it is 'hurting a little'; i dont feel great with the heat; This is a spontaneous report from a contactable consumer or other non hcp. A 73-years-old female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: not reported) via unspecified route of administration on unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced her ankle is swelling up again on 2021, it is 'hurting a little' on 2021, I don't feel great with the heat on 2021.Patient wanted to know that she can take Advil for the pain. The outcome of the condition aggravated, pain, feeling abnormal was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
6 days after vaccinations, the patient developed a tiny red pinpoint dot type of rash on her belly and back that progressed up to the face.  She developed a fever of 101F and acted sick.  Mom described daughter as fussy, crying, and not eating.  By day 10 after vaccination, the rash started resolving.  Pt was seen by her medical provider who noted a swollen left groin lymph. node