chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Cramps in her legs; Dehydration; Kept getting worse; Feels like something in her ears; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE SPASMS (Cramps in her legs), DEHYDRATION (Dehydration), CONDITION AGGRAVATED (Kept getting worse), EAR DISCOMFORT (Feels like something in her ears) and NAUSEA (Nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026A21A and 026B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On an unknown date, the patient experienced MUSCLE SPASMS (Cramps in her legs), DEHYDRATION (Dehydration), CONDITION AGGRAVATED (Kept getting worse), EAR DISCOMFORT (Feels like something in her ears) and NAUSEA (Nausea). At the time of the report, MUSCLE SPASMS (Cramps in her legs), DEHYDRATION (Dehydration), CONDITION AGGRAVATED (Kept getting worse), EAR DISCOMFORT (Feels like something in her ears) and NAUSEA (Nausea) outcome was unknown.            No concomitant medications were reported.  Treatment medication included magnesium tablets   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: NNI
No adverse event; A pediatric patient less than 5 years old received a 0.2 ml dose of the moderna COVID-19 vaccine with the pink cap and the label with the yellow border; This spontaneous case was reported by a physician and describes the occurrence of WRONG PRODUCT ADMINISTERED (A pediatric patient less than 5 years old received a 0.2 ml dose of the moderna COVID-19 vaccine with the pink cap and the label with the yellow border) and NO ADVERSE EVENT (No adverse event) in a 7-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  Previously administered products included for Product used for unknown indication: PENTACEL on 23-Mar-2023, ROTATEQ on 23-Mar-2023, VAXNEUVANCE on 23-Mar-2023 and FLUZONE [INFLUENZA VACCINE] (second) on 21-Apr-2023. Past adverse reactions to the above products included No adverse event with FLUZONE [INFLUENZA VACCINE], PENTACEL, ROTATEQ and VAXNEUVANCE.    On 27-Apr-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 27-Apr-2023, the patient experienced WRONG PRODUCT ADMINISTERED (A pediatric patient less than 5 years old received a 0.2 ml dose of the moderna COVID-19 vaccine with the pink cap and the label with the yellow border). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (A pediatric patient less than 5 years old received a 0.2 ml dose of the moderna COVID-19 vaccine with the pink cap and the label with the yellow border) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        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 WRONG PRODUCT ADMINISTERED (A pediatric patient less than 5 years old received a 0.2 ml dose of the moderna COVID-19 vaccine with the pink cap and the label with the yellow border).    No concomitant medications were provided. Patient did not experienced any symptoms.  No treatment medication was provided.
Pfizer vaccine.  Took the 2nd dose on 2/17/2021 at university, in March or April, start having bumps, itches.  A few a day, all on the right side of the body.  Eventually, no more broke out. Had booster at store.  Pretty much like last time, 3 or 4 weeks later, start having a big itchy bump on the leg, the next week on left tummy, let risk, the next time, on left neck, like a "huge" insect bitten bump.  Last night at 6:30 pm, I was sitting on the couch and my left leg start itching.  I scratched it a few times with my sweat pant fabric, didn't go away.  I pull up the leg of the pants and found a huge patch of dark red bubble bumps, 8 to 9 inches long and 3 inches wide.  Immediately took a Benedrly and put hydrocortisone on it.  Calm the itch down and took another one before I go to sleep.  In the morning, it flattened out and calm down.  made an appointment to see my family doctor.
his body is fainted; weakness; his eyes are burning; swollen arm; accelerated heart; nose congestion; fatigue; his body feels hot; chills; A spontaneous report  was received from a consumer (reporting on self), concerning male patient (age unspecified) who received Moderna's COVID-19 Vaccine (mRNA-1273) and fainted along with  chills, fatigue, hot, burning eyes, weakness, swollen arm, accelerated heart and nose congestion.  The patient's medical history was not provided.   Concomitant medications included metoprolol and acetylsalicylic acid.  On 16 Mar 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot unknown) intramuscularly for prophylaxis of COVID-19 infection.   On 17 Mar 2021, the patient developed chills, fatigue,  hot, burning eyes, weakness, swollen arm, accelerated heart and nose congestion and eventually fainted, details were not provided. Treatment included Tylenol (paracetamol).  The adverse event of his body is fainted was assessed as medically significant.  Action taken with mRNA-1273 in response to the events was not reported.   Outcome of the events was unknown.; Reporter's Comments: Very limited information regarding this event/s has been provided at this time.  Further information has been requested.
This case was reported by a pharmacy clinical coordinator via a sales representative, and described the occurrence of red face in a female subject of unspecified age who was vaccinated with Fluarix, GlaxoSmithKline for prophylaxis.  On 1 October 2007 at 13:00 the subject received the first dose of Fluarix (.5ml, unknown) at a pharmacy influenza vaccination clinic.  On 1 October 2007, within 3 hours of vaccination with Fluarix, the subject experienced redness of the face and neck and neck stiffness.  At the time of reporting the events were unresolved.
Presented to ER on 5/12/12 at 11:30 AM to report reaction symptoms included fever, chills, body aches. Reports Rt arm had patchy areas that were red, warm to touch & swollen. No TX or meds prescribed. 5/14/12 presented to HD at 9:00 AM to report reaction. Rt arm has patchy areas that are red, warm to touch & swollen area is 2 inches below to of shoulder to 2 inches above elbow. Pt doing warm compresses & ALEVE.
Within 2 weeks of the 4th covid vaccine aggressive onset Alopecia  began. Within the course of 3 weeks 80% of all scalp  hair was lost and is continuing.
diarrhea; fever; Body is aching; headache; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine and experienced diarrhea, fever, body aches and headache.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 30 Dec 2020, approximately 9 hours prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection.   On 30 Dec 2020, the patient started to feel "super sick" with diarrhea, fever, body aches and headache. No treatment information was reported.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, diarrhea, fever, body aches and headache, was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Rash at the injection site; redness at Injection site; warm to touch, 4 by 5 inches; Headache; Blurred vision; This case was reported by a consumer via call center representative and described the occurrence of injection site rash in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number 4NY45, expiry date 15th September 2023) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number Y9JS7, expiry date 30th June 2023) for prophylaxis and flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Zostavax (received on an unknown date).   On 20th October 2022, the patient received Shingrix, the 1st dose of Fluarix Quadrivalent 2022-2023 season (intramuscular) and Fluarix Tetra Pre-Filled Syringe Device. In October 2022, less than a week after receiving Shingrix, Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site erythema and injection site warmth. On 20th October 2022, the patient experienced headache. On 21st October 2022, the patient experienced blurred vision. On 24th October 2022, the patient experienced injection site rash. The patient was treated with topical steroid nos (Steroid Cream) and antibiotics nos (Oral Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the injection site rash was not recovered/not resolved and the outcome of the injection site erythema and injection site warmth were unknown and the outcome of the headache and blurred vision were recovered/resolved.   It was unknown if the reporter considered the injection site rash, injection site erythema, injection site warmth, headache and blurred vision to be related to Shingrix, Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 26-OCT-2022 Reporter's comment: The case was self-reported by the patient. The patient received a dose of Shingrix and Fluarix into left deltoid and experienced headache immediately. The headache resolved after 3 days. The day after vaccination, the patient experienced blurred vision that resolved after 2 days. Four days after vaccination, the patient developed a rash at the injection site. The rash was red, warm to touch and about 4 inches by 5 inches. The borders of the rash were well-defined and rectangular, not curved.  The patient's doctor initially prescribed a steroid cream to treat the rash. He then prescribed an oral antibiotic because the rash was warm to the touch. No other details were reported. The reporter consented to follow up.
Stroke. Awoke without speech, unable to communicate. Confirmed stroke with aphasia and apraxia by CT and MRI at Clinic. Less than 2 weeks following Clinic recommended 4th Moderna Covid shot. Doctor notes from hospital stay and MRI and CT included below:  "Acute infarction in the left frontal operculum and insula secondary to an occlusion of a left inferior M2 branch and M3 branch along the insular cleft. The hyperdense occlusions are likely calcified and embolic in etiology."  "Acute left MCA territory infarction involving left frontal operculum and insula with one-to-one correspondence of DWI and FLAIR signal abnormalities." 'Suspected stroke mechanism: cardioembolic or cryptogenic"
This spontaneous report was received from a physician refers to an unspecified number of patients of unknown age and gender. No concurrent condition or medical history was reported. It was reported that on an unknown dates since May 2015, the patients were administered improperly stored dose of PEDVAXHIB (lot # K008877, exp. 24-FEB-2017, dose and route of administration not provided). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. This is one of the several reports from the same reporter. Additional information has been requested.
Pt devel hives following DTP/HBOC/OPV immun; event occurred in 1989;
Painful itchy rash, in area of inoculation and upper arm and shoulder. Treated with Benadryl. Rash as lasts 6 days. High blood pressure, elevated heart rate and elevated blood glucose for 24 hours. Treated with extra strength Tylenol.
"Covid arm" started to develop a week after the injection. At first, it was a 2" redness at the injection site. Then by 2/10 it was 4 1/2 " long and 3" wide. Hot to the touch, swollen, itchy, skin felt hard. Also mild body aches a week after the injection,  which ibuprofen relieved.
Patient passed out after receiving vaccine, revived after 1-2 minutes, threw up, passed out again, revived again after 1-2 minutes. 20 minutes later patient was feeling better and left the store.
Headache, Myalgia, Arthralgia, FATIGUE; INJECTION SITE REACITON Narrative:
Patient had hives on face and spreading down neck. No breathing difficulties noted two hours after injection. Mother brought patient back to clinic to be evaluated. Patient given 4mg IM DECADRON.
10 days after the 1st dose my daughter had a mild seizure.....she was taken to the Emergency department where a CAT scan was done.          10 days after the 2nd dose full blown seizure convulsion where it cause her to fall, ambulance was called took her to the ER, she saw the neurologist .    She is now on Levetriracetam 10ml twice daily which is causing side effects to control the seizures
Pt recv vax on 10/07/98; on same day pt exp lethargy; 10/8/98 pt exp vomiting, light stool color; 10/16/98 pt exp fever (103.3F)
got Pfizer vaccine and then a third dose of Moderna; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got Pfizer vaccine and then a third dose of Moderna) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Stem cell transplant in October 2021. Previously administered products included for Product used for unknown indication: Pfizer. Past adverse reactions to the above products included Adverse reaction with Pfizer.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got Pfizer vaccine and then a third dose of Moderna). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got Pfizer vaccine and then a third dose of Moderna) had resolved.            After the transplant patient did an antigen test, in November 2021 and patient had some immunity, 2.90 or something. patients doctor told to get revaccinated from scratch on the 3rd month since patients transplant.  No concomitant medication was reported.  No treatment medication use was reported
Patient developed arm numbness, swelling and redness on the left arm, report feeling nausea and vomiting, and diarrhea after the injection. Patient felt extremely drowsy and fatigue, as a result, patient was absent from work for 3 days. Patient was advised to do warm compress, take IBU and go to emergency for evaluation.
Inappropriate Reconstitution Technique/Menveo powder component reconstituted with a non-GSK diluent; Inappropriate Reconstitution Technique/Menveo powder component reconstituted with a non-GSK diluent; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Inappropriate Reconstitution Technique/Menveo powder component reconstituted with a non-GSK diluent) and inappropriate dose of vaccine administered (Verbatim: Inappropriate Reconstitution Technique/Menveo powder component reconstituted with a non-GSK diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 16-AUG-2023 The reporter called to inquire on any guidance and any information on effectiveness. The reporter reported that they noticed they had an extra vial of Menveo diluent component and the lyophilized vial was missing.  The reporter was still investigating and was unsure if a patient was administered or not. The reporter was unable to provide any vaccine or patient details. The reporter did not consent to follow-up. The reporter mentioned that they thought a patient might had been administered with a Menveo powder component reconstituted with a non-GSK diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
intense itching lt upper arm around inj site 4"x 6" area erythema;
Red whelp at and around injection site; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204) via an unspecified route of administration in the left arm on 30Mar2021 at 10:30 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. Medical history included factor's deficiency, ulcerative Colitis, rheumatoid arthritis, deep vein thrombosis and multi-modular thyroid. The patient had known allergy to contrast dye for MRI. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6202) via an unspecified route of administration on 09Mar2021 (at the age of 41-year-old) as a single dose for COVID-19 immunisation. The patient had unspecified concomitant medications from an unknown date for unspecified indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. . On 30Mar2021 at 16:00, the patient experienced red welp at and around the injection site after second injection. The patient did not receive any therapeutic treatment for the adverse event. The adverse events did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  The clinical outcome of the event red welp at and around the injection site was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
PATIENT RECIEVED HER 2ND COVID MODERNA VACCINE IN RIGHT ARM AND WITHING 30  SECONDS LOST CONSCIOUSNESS ( SYNCOPE). PATIENT LOST CONSCIOUSNESS FOR 15 TO 30 SECS AND THEN CAME BACK TO CONSCIOUSNESS. SHE WAS BREATHING HEAVILY AND THEN STARTED TO COMPLAIN THAT SHE WAS FEELING TINGLING  IN HER WHOLE BODY AND THEN SHE STARTED TO SWEAT. SHE WAS FEELING LIKE HER FINGERS ARE SWELLING. PARAMEDICS 911 WERE CALLED RIGHT AWAY AT THE FIRST SIGN OF SYNCOPE.
Woke up with severe headache(I never get headaches) -couldn't even get out of bed until 2 pm  Took TYLENOL around noon----much better by 6pm. Back to normal next morning.
Started to break out with rash on chin Saturday (7Nov09). On Sunday (8 Nov 09) broke out with rash on legs with itching. Itching and rash have not disappeared as to today (10 Nov 09) will start taking Benadryl and apply Hydrocortisone.
101 fever, fussy, irritable, crying x 5 hours. Motrin given : better after Motrin
This spontaneous report was received from a medical assistant regarding a 4 month old patient of unknown gender. The patient's medical history, concurrent conditions were not reported. On 05-APR-2016, the patient was vaccinated with improperly stored dose of ROTATEQ (lot # L029618, expiry date 20-MAY-2017) dosing details and route unknown. Concomitant medications were not reported. It was reported that the vaccine administered was subjected to temperature excursion of 48 degrees Fahrenheit for a time frame of 11 hours and 10 minutes. No adverse effects were reported. Product quality complaint (PQC) was not filed. Additional information has been requested.
Experienced  severe allergic reaction resulting in anaphylaxis requiring emergency treatment @ ER. Swelling of face and neck, eyes swollen shut, hives on upper body, difficulty breathing.
Initial information received on 01-Oct-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a 59 years old female patient who experienced generalized body aches and arm pain at injection site, while she received vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in the left arm. On an unknown date, the patient developed a non-serious generalized body aches and arm pain at injection site, following the administration of INFLUENZA QUADRIVAL A-B VACCINE. Relevant tests were not reported. Final diagnosis was generalized body aches and experienced arm pain at injection site. It was not reported if the patient received a corrective treatment. The event outcome was not reported for generalized body aches and experienced arm pain at injection site. List of documents held by sender: none.
Severe swelling at site of injection which spread around 4 to 6 cm; A spontaneous report was received from other health professional concerning a 34-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced severe swelling at site of injection which spread around 4 to 6 cm.     The patient's medical history was not provided. No relevant concomitant medications were reported.     On 19 Jan 2021, nine days prior to the onset of the event severe swelling at site of injection which spread around 4 to 6 cm, the patient received their dose of mRNA-1273 (lot/batch: 012l20A) for prophylaxis of COVID-19 infection.   On 27 Jan 2021, the patient experienced severe swelling at site of injection which spread around 4 to 6 cm. Treatment for the event included steroids.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event severe swelling at site of injection which spread around 4 to 6 cm was recovering (subside).; Reporter's Comments: 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.
SORE ARM; This spontaneous report received from a patient via a company representative concerned a male 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the subject experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of sore arm was not reported. This report was non-serious.