chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Had a sore arm) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     Concurrent medical conditions included Osteoarthritis (The patient has severe osteoarthritis.). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, the patient experienced PAIN IN EXTREMITY (Had a sore arm). On 19-Feb-2021, PAIN IN EXTREMITY (Had a sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Follow up received on 29 -Apr- 2021 contains non significant information ( reporter does not have an email).
fatigue; headache; nausea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea) in an 88-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE, ACETYLSALICYLIC ACID (ASPIRIN 81) and ATORVASTATIN for an unknown indication.   On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea). At the time of the report, FATIGUE (fatigue), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown.            Action taken with mRNA-1273 in response to the events was not Applicable. No treatment medications provided by the reporter.
1st shot- developed fever, chills, constant coughing, tiredness. 2nd shot- cough up rusty color phlegm. sometimes color is red, other times more of a rusty orange. Feel very tired, dizzy, loss of balance
Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in a 60-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS5051C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 15-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was provided.  No treatment information was provided.   Reporter did not allow further contact
Pt c/o vertigo 12 hrs after flu shot given - lasted 1 day.
Intermittent numbness in left arm, below elbow from 5/22/2000 to 5/26/2000. Anthrax was received in upper left arm. Duration was 2-5 days, post vax.
Developed Bell's Palsy on Rt. side on 3/14/12 unable to smile equally broadly or shut eye completely. Mild ptosis. Unable to raise eyebrows for a few weeks, then full resolution by 2-3 mos. Saw neurologist & ENT. Took MEDROL dose pack; used artificial tears.
This spontaneous report as received from a 68 years old female patient concerning herself with no medical history and no drug allergies. The patient was vaccinated with ZOSTAVAX (subcutaneous, lot# was unknown) on 03-OCT-2012. Concomitant medications included: vitamins (unspecified). On 03-OCT-2012 the patient had an inflamed area on her left arm at the injection site. She had itching, and it was swollen, she also had a pinching feeling. The patient said the area had white welt type bumps, which her pharmacist advised he had not seen. The patient sought medical attention and hydrocortisone was given for the treatment of the adverse events on 09-OCT-2012. No lab diagnostics studies performed. The outcome of the adverse events was unknown at the time of the report. Additional information has been requested.
Site: Itching at Injection Site-Medium, Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Additional Details: patient reports hives approximately at 3 am day after receiving vaccine, took claritin, and has moved on to benadryl
Breakthrough COVID  Dose 1: 02/05/2021, Moderna, 013M20A Dose 2: 03/05/2021, Moderna, 030A21A Dose 3: 11/18/2021, Moderna, 939904
Took Johnson & Johnson vaccine on March 13th 2021, took Pfizer booster on 10/22/21; Took Johnson & Johnson vaccine on March 13th 2021, took Pfizer booster on 10/22/21; Fever; Vomiting; Very sick for four days; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCIN), via an unspecified route of administration on 22Oct2021 (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN (BOOSTER), SINGLE for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  Patient took Johnson & Johnson vaccine on 13Mar2021. The patient experienced took johnson & johnson vaccine on march 13th 2021, took pfizer booster on 22Oct2021, fever in Oct2021, vomiting in Oct2021, very sick for four days in Oct2021.Outcome of fever vomiting very sick was recovered in Oct2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Initial solicited report received from a consumer (online market research respondent) in the below mentioned study on 04 December 2015. The subject (gender and age were not reported) got deathly sick with the flu from an unspecified date, after receiving a dose of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (date of vaccination, site and route of administration and batch number were not reported). The medical history and concomitant therapy details were not reported. The subject took the high dose "last year" and got deathly sick with the flu and so the subject would never take it again. The lab data and corrective treatment details were not reported. The outcome of the event was not reported. Relationship to investigational product according to company: not associated. Relationship to investigational product according to reporter: not reported. List of documents held by sender: none.
Received a flu shot on 10/10/07. Got flu on 10/16-17/07. Had no major exposure to persons with flu. Believe it resulted from the shot. Have not had flu in past 25 years. had shot each year.
about 24 hours after vaccination with covid-19 (Pfizer) vaccine, patient had a 5 minute seizure. Patient fell while having seizure and hit his head.
presented 17SEP97 w/3" red round raise down lt deltoid around inj site;warm to touch c/o itching;cellulitis lt upper arm;
Caller stated an expired VARIVAX was administered to a female patient today.; This spontaneous report was received from a licensed practical nurse, referring to an infant (also reported as "patient age: around 12-months old") female patient. The patient's pertinent medical history, current conditions, previous drug reactions or allergies and concomitant medications were not reported.   On 16-DEC-2020, the patient was vaccinated with one expired dose (expired product administered) of varicella virus vaccine live (oka/merck) (VARIVAX) vials, as prophylaxis (strength, vaccination scheme, anatomical site of vaccination and route of administration were not provided; lot number R033660 which has been verified to be valid, expiration date reported and validated as 20-NOV-2020). The vaccine administered did not experience previous temperature excursion.
A report has been received from a Study Investigator concerning drug exposure during pregnancy in a 29 year old, female subject. The patient's medical and concomitant history was not provided at the time of reporting. The patient received FLUMIST quadrivalent (intranasal) on 28-Sep-2013. The patient experienced drug exposure during pregnancy on an unknown date. The outcome of the pregnancy was reported to be a healthy baby. The investigator assessed the event of drug exposure during pregnancy to be non-serious.
The nurse sated that she reconstituted the 5-11 year old Pfizer Covid-19 vaccine with 1.8 ml of 0.9% of normal saline instead of 1.3 ml.
Pain at injection site. Edema after 1 day below affected arm at elbow with LLE pain.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Information regarding medical history, concurrent conditions and concomitant medications was not provided. On or about 27-JUL-2016, the patient was inoculated with ZOSTAVAX at a market as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. Later in 2016, the patient was treated at a doctor's office for a blistering vesicular outbreak, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Patient received a dose of Menveo reconstituted with sterile water; Patient received a dose of Menveo reconstituted with sterile water; This non-serious case was reported by a nurse and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number SKBAMVAT21A) for prophylaxis.   On 03-AUG-2023, the patient received Menveo. On 03-AUG-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Patient received a dose of Menveo reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Patient received a dose of Menveo reconstituted with sterile water).  The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-AUG-2023 The reporter reported that the patient received an incomplete dose of Menveo vaccine. The reporter reported that the patient received Menveo vaccine reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up. This case was 1 of 3 cases for the patient reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR121432:same reporter, drug and event US-GSK-US2023AMR121432:same reporter, drug and event
Case number PHEH2013US012006, is an initial spontaneous report received from a medical assistant on 30 May 2013: This case refers to a male patient of unspecified age. He received only MENVEO, (batch number: M12026), intramuscularly without being reconstituted with Men A component on 29 May 2013. No adverse reaction reported following this administration error.
Pt recv vax in 12/96; 1 hr post vax pt exp swollen eyes, red face, irritable, fever (104-105), eyeballs red &burning, spine spain
Swelling by left armpit, between arm and breast; Swelling by left armpit, between arm and breast; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0202), via an unspecified route of administration, administered in arm left on 16Jun2021 14:00 (at the age of 56-years) as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 17Jun2021 19:00, the patient experience Swelling by left armpit, between arm and breast. The patient did not receive any treatment for adverse event. The patient did not have Covid prior vaccination, and the patient did not test for covid post vaccination. The patient did not have known allergies. The outcome of the events was not recovered.   Follow-Up (05Aug2021), Follow-up attempts are completed. No further information is expected.
Initial report received from a pharmacist on 22 Dec 2009: This patient, with an unknown medical history, was vaccinated with previously frozen FLUVIRIN vaccine (batch no. 102135P1), intramuscularly, on 21 Dec 2009. No adverse event was reported. No other information was provided.
Initial information received on 26-Sep-2018 regarding an unsolicited valid non-serious case received from other health care professional. This case involves a seven years old patient (unknown gender) who was vaccinated with a 0.5ml dose of QUADRACEL (Batch number: C5248AA, expiration date: 21-Aug-2019, route: intramuscular and site of administration: right deltoid) on 22-May-2018 instead of ADACEL (Batch number, expiration date and dose were not reported). Concomitant medications included was MMR and VARICELLA VACCINE (Batch number, expiration date, dose, route and site of administration was not reported). The patients medical history were not reported. It was an actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered. No adverse event reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
extreme weakness, collapsed,  ultimately patient was determined through repeated multiple blood tests excessively high inflammatory markers over a period of weeks, severe shortness of breath, confusion, fluid accumulation around the lungs.  All is documented in Dr records as well as Hospital
Developed hives more than 72 hours after administration with pruiritis and also swelling of hands and feet. No DIB. No wheezing. Throat or chest tightened - did have slight cough. Taken to ER. Prednisone prescribed.
This spontaneous report was received from a registered nurse and refers to an unspecified number of patients of unknown age and gender. There was no information regarding the patients' pertinent medical histories, drug reactions, allergies or concomitant therapies provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L035637, expiration date 09-JUN-2017 and lot # L039638, expiration date 23-AUG-2017, orally; exact doses were not reported). No adverse effect was reported. This is one of the several reports received from the same reporter. Follow up information was received on 07-DEC-2016. All telephone attempts to obtain follow up information have been unsuccessful. Additional information has been requested. Sender's Comments: US-009507513-1610USA009070: US-009507513-1610USA009068: US-009507513-1610USA009071: US-009507513-1610USA009069: MERCK 1610USA001492:Mfr number.
Patient reported to ER with complaint of redness and itching of the arm after vaccination. Patient reports the day after the covid and flu shot she had some itching that would not go away on her right arm and thought that it was her sweater making her itch. This nurse noticed on the right arm slight redness below vaccination site with some bruising at vaccination site. Reports that it has not gotten any better or worse and is still itchy and tender. Does report that it feels better with cold compress. Redness measure 4.5 inches in length from shoulder to elbow, and 3.5 inches from outer arm to inner arm. Patient denied any shortness of breath, difficulty breathing, tightness in the chest, blurry vision or light headedness. Patient is taking atorvastatin, multivitamin and naproxen.
Please stated that she felt hot, short of breath, and her tongue was tingling.  Epinephrine given to Right outer thigh @ 1445 and Pt. sent down to Emergency Dept.
on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; on Friday 29th at approximately 6pm I had some difficulty with my breathing and again on Sunday 31 of Jan but not as bad as the 29th and again on Feb 2 and 3 so far as of 02/6/21 I have not had any mo; This is a spontaneous report from a contactable consumer, the patient. This 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: paa156051),  dose 1 , single dose via an unspecified route of administration in the left arm on 27Jan2021 at 12:30 PM for COVID-19 vaccination. Medical history was not reported. The patient was not pregnant. There were no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient received other unspecified concomitant medications. The patient did not receive  any other vaccine within 4 weeks prior to the vaccine.  On Friday, 29Jan2021 at approximately 6pm, the patient had some difficulty with her breathing and again on Sunday 31Jan2021 but not as bad as the 29Jan2021 and again on 02Feb 2021 and 03Feb2021. As of 06Feb2021, she has not had any more breathing problems and had the headache and chills for the first week. She went to urgent care on 01Feb2021 and was given a chest X-ray, bloodwork, electrocardiogram (ECG) and a COVID test all were normal. No treatment was received for difficulty with her breathing, headache and chills. The clinical outcome of difficulty with her breathing, headache and chills was recovered on an unknown date. It was also reported that since the vaccination, the patient had been tested for COVID-19 on 05Feb2021 and was negative.
Upon waking up I stood up from bed and felt light headed and sat down on the floor and had a moment of unconsciousness reported by my Husband for about 10 seconds. I came to and drank water and took my blood pressure (110/64) and called my healthcare provider. They said it was most likely due to the vaccine and if it happened again to go to the ER.
LIGHT HEADED MOSTLY WHEN STAND UP; LOOSE BOWELS; This spontaneous report received from a patient concerned a 71 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included blood pressure issues. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 in the left deltoid for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On MAR-2021, the subject experienced light headed mostly when stand up. On MAR-2021, the subject experienced loose bowels. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the light headed mostly when stand up and loose bowels was not reported. This report was non-serious.
joint pains,severe h/a's & low platelet count ever since receiving rabies post exposure in March as reported by wife 18AUG94;numerous test do not show anything;
Positive COVID-19 test (4/10/2021) 8 days after 2nd dose administered, symptomatic. Repeat COVID-19 test for pre-procedure (colonoscopy ) on 7/4/2021 positive.
Large injection site reaction. Redness about 4 inches in diameter (about the size of an orange) including 1/2 inch raised knot under the skin. Skin was hot to the touch as well. Injection site did not hurt to touch according to the patient. The reaction remained about the same size all day on 10-29-19. Patient was instructed to apply ice for swelling. Patient took dose of benadryl and was instructed to use Tylenol or Ibuprofen if needed. By 10-30-19 at 8:50am the injection site was much better and by 10-31-19 at 12:27pm the redness was completely gone.
Nosebleeds almost every morning since vaccine. Left nostril only. Begin about one hour after waking. My morning routine has not changed since vaccine.
None- vaccine given 6 days post expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Nov-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry). On 12-Nov-2021, EXPIRED PRODUCT ADMINISTERED (None- vaccine given 6 days post expiry) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.   This case was linked to MOD-2021-395985 (Patient Link).
PT PRESENTING WITH VERY LARGE 5x6" RED SWOLLEN INDURATION SURROUNDING VARICELLA INJECTION SITE, SMALL BLISTER LIKE PAPULES NOTED AROUND IMMEDIATE NEEDLE SITE; PATIENT'S MOTHER STATES REDNESS AND SWELLING GETTING WORSE; INDURATION WARM TO TOUCH; ADVISED PATIENT TO APPLY COOL COMPRESS, HYDROCORTISONE CREAM, TO TAKE BENADRYL
BELLS PALSY; This spontaneous report received from a consumer via a company representative through social media concerned a patient of unspecified age, sex, race and ethnic origin.  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 administration not reported, batch number: Unknown expiry: Unknown) dose, start therapy date were not reported, 01 total administered for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was reported that, "the patient got bells palsy exactly 1 month after the J and J jab." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211034768-COVID-19 VACCINE AD26.COV2.S-Bells palsy. This event is considered unassessable. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.