chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Injection site redness; It is very big like the size of a quarter; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (It is very big like the size of a quarter) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025120A) for COVID-19 vaccination.     Concomitant products included CORTISONE from 13-Jan-2021 to an unknown date for Knee pain, LOSARTAN, LEVOTHYROXINE SODIUM (SYNTHROID), THYROID (ARMOUR THYROID) and IBUPROFEN for an unknown indication.    On 03-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE ERYTHEMA (Injection site redness) and INJECTION SITE SWELLING (It is very big like the size of a quarter). At the time of the report, INJECTION SITE ERYTHEMA (Injection site redness) had not resolved and INJECTION SITE SWELLING (It is very big like the size of a quarter) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; 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.
Patient felt dizzy and had itching and rash at injection site that appeared to be getting larger.  Chest felt tight and blood pressure was elevated.
Fever of 102° The day after injection Severe vomiting on day 3 after injection  Redness and swelling at injection site on day 3
No adverse effect reported; patient received improperly stored VARIVAX; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 13-AUG-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # R019237, expiration date 04-JUL-2020 or lot # S005078, expiration date 19-FEB-2021 (the office did not know which lot was given to which patient, dose and route of administration were not reported). The varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with properly stored sterile diluent. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of -14 to -10 (-9.74 degrees Celsius for an unknown time frame. Data logger was involved. There were no previous excursions reported.
Patient accompanied his father to the clinic for a routine appt. to give his father IV fluids.  When they arrived they both asked when they were going to get their Covid 19 vaccine.   The clinic was running a vaccine clinic that day and we had extra doses.  I asked  how old he was and he said 16.  His father was sitting next to him.  I gave his Covid 19 vaccine and then realized that his DOB he was not yet 16.  He and his dad are aware of this incident and he denies any adverse affects from the vaccine at the time of this report.
Redness to the arm, its feels hot, and spreading down towards the arm; Redness to the arm, its feels hot, and spreading down towards the arm; Initial information received on 13-Oct-2020 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 63 years old female patient who experienced redness to the arm, its feels hot, and spreading down towards the arm and redness to the arm, its feels hot, and spreading down towards the arm (feeling hot and erythema), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s), family history and concomitant medication were not provided.  On 12-Oct-2020, the patient received a 0.5 ml once dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [lot number UJ462AA expiration date 30-Jun-2021] via unknown route in the right deltoid.  On 13-Oct-2020, the patient experienced a non-serious redness to the arm, its feels hot, and spreading down towards the arm and redness to the arm, its feels hot, and spreading down towards the arm (feeling hot and erythema),  1 day after following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Other relevant tests included no lab data.  Final diagnosis was feeling hot and erythema.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown.
Beginning on Sunday, 3/21, I began to have itchiness at the injection site. On Monday morning, I have a red spot approximately 2" in diameter around the injection site. The site was red and warm to touch. By evening on Monday, 3/22, I begin to feel itchy throughout my entire body.
Patient called pharmacist to let her know that her arm was sore and red from the shots received 3 days prior and that it didn't start until the night before. When asked if she might have done anything to make her arm feel sore she said that she shoveled snow that day but that she noticed the redness on her arm before that a little. She also stated that she got held over at work and worked longer than normal. Pharmacist instructed the patient to watch the site and to come in so the pharmacist could check out the patient but she said that she would just send a picture to her physician over email. Pharmacist called patient the next day to see how she was doing and patient said doctor said it was a normal reaction and that she can put a warm compress on it if it is still sore.
Pneumonia due to COVID-19 virus, received dexamethasone and remdesivir during hospital stay. Discharged home. ED visit and hospital admission within 6 weeks of receiving the COVID vaccine.
Patient had loose watery green stools starting  6/10/22 and lasting for 10 days.
Mother reported that subsequent to receiving vax pt developed a mild fever and recovered. No further info was available at the date of the report.
Currently pregnant due date 7/27/21. Developed a rash w muscle and joint pain on right arm in May 2021, several months after vaccine was administered. Symptoms improved but have recently flared up again.
Erythema Multiforme with no treatment other than Benadryl prn itching.
Patient came to conference room shortly after receiving her first dose of the Pfizer vaccine with complaints of tingling in her face and said she felt like she was going to pass out. She denied chest pain, shortness of breath or difficulty swallowing. She was alert to time, place, and event. Her skin was normal color and warm to touch. Upon questioning her she said she was nervous about getting the vaccine and had only had coffee this morning, but nothing to eat. Staff began obtaining her first set of vital signs and asking about medical history. She denied diabetes but said she did have high blood pressure but did not take medication (she said her normal BP was 140s/85-95). We gave her water and saltine crackers to see if her symptoms would resolve. After a few minutes she said she was still having the same feelings, though they had not gotten worse. At this time I checked her vital signs and conferred with staff. We encouraged her to seek further treatment and be transported to the emergency department via EMS. Patient refused ambulance and said she would have her husband drive her (he was in the room with us at this time and agreed to take her to local emergency department). We transported patient to her vehicle via wheelchair. Staff called ED and gave report of these events to one of the ED nurses. I told her husband we would reach out later today to follow up with the situation.
Worst was nausea, vomiting and diarrhea for several hours; also tiredness, aches, chills and brain fog for several days
felt like my throat was closing up; pain and stiffness in right arm; pain and stiffness in right arm; fatigue; muscle aches; This is a spontaneous report from a contactable consumer or other non-health care professional. A 34-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection, Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in the right arm on 04Mar2021 15:45(age at the time of vaccine 34-year-old) as dose 1, single for covid-19 immunisation in the workplace clinic. The patient's medical history was not reported. Concomitant medications included ascorbic acid, ferrous bisglycinate, levomefolic acid, mecobalamin, pyridoxal phosphate (FERRASORB), Chaste Tree Berry, acetylcysteine, selenomethionine, sodium molybdate (NAC), ubiquinol (UBQH), melatonin. Patient did not receive other vaccines in four weeks. Patient did not have COVID prior vaccination. Patient did not test COVID post vaccination. On 04Mar2021 at 15:45, the patient experienced felt like my throat was closing up, pain and stiffness in right arm, fatigue and muscle aches. No treatment was received for the events. The outcome of the events felt like my throat was closing within an hour was recovered on 04March2021. The patient was recovered from pain and stiffness in right arm on 06March2021 (resolved within 48 hours). The patient was recovered from fatigue and muscle aches on an unknown date in Mar2021.  No follow-up attempts are possible. No further information is expected.
No reaction at all until day 7 on Jan 16.  New onset tonight of itching at injection site, multiple induration "lumps" over a 4cm area. NO wheezing, shortness of breath or other swelling. I am self-reporting this to website and have not needed to seek medical care thus far
Constant pain in area of vaccine for past 30 days. Muscle pain, tenderness and stiffness
doses administered after more than 1 temperature excursion; doses administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Mar-2021 at 11:48 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 20-Mar-2021 at 11:48 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (doses administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (doses administered after more than 1 temperature excursion) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 64.42.  Concomitant products were not provided.  On 20-Mar-2021, Excursion time was 9 AM, temp was 34 and at 10 AM temp was 37; total doses given for the day was 184, condition of vaccine prior to vaccination was not frozen, vaccine was moved to fridge on 09-Mar-2021, vial was moved to clinic on 20-Mar-2021. 19 vial was moved to clinic. Vaccine BUD date was 08-Apr-2021.   The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic.  Temperature recordings were taken using a Fisher brand traceable temperature monitor at every hour.  The vial was not in a frozen state at the time of vaccine administration.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that unknown number of patients were administered with vaccines that experienced more than 1 temperature excursion during 33 weeks on 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
Information has been received from a physician concerning a 12 month old male who on 11Mar05 was vaccinated (route unk) with a dose of varicella virus vaccine (649274/0896P). Subsequently, in March 2005, the pt developed diarrhea and vomiting and was hospitalized. On 25Mar05, while hospitalized, the pt experienced a few, mild varicella lesions. Subsequently, the pt recovered from the few, mild varicella lesions on an unk date. Unspecified medical attention was sought. No product quality complaint was involved. Information received on 04Apr05 contained the following adverse experiences vomiting and diarrhea. Additional information has been requested.
Pt recvd DTP/OPV 15JUL91 & pt noted to be crying alot, no fever noted; t97.6 AX; crying was later high pitch & lasted about 4 hrs; Area of shot felt warm & swollen the 1st day;
not gotten menstrual period; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION DELAYED (not gotten menstrual period) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-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 MENSTRUATION DELAYED (not gotten menstrual period). At the time of the report, MENSTRUATION DELAYED (not gotten menstrual period) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant products were reported. No Treatment information reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Follow-up received on 27-APR-2021
They made me wait 20 mins to make  sure I didn't have a reaction, went home and was fine.  A couple days later I started itching and the next Monday it was worse. I woke up  the next morning with a rash on my face, right arm, head, all over my chest moving to my legs.  It just got worse and hurt so bad, so i went to the ER right away. They put me on IV pecid and Benadryl, that didn't help. They put me on a steroid IV, tat really calmed the itching down. I was in the ER about 2 hours and then they sent me home.  They sent me home with steroid and hydroxyzine HCL -10mg  1/3x days.  It took about a week and a half for the rash to go away. I still have some itching but not a problem.
Case number PHEH2014US020576, is an initial spontaneous report from a nurse received on 10 OCT 2014. This report refers to a 57-year-old male patient. Past medical history and concomitant medications were not reported. On 10 OCT 2014, the patient was vaccinated with 0.5 ml of FLUVIRIN 2014/2015 (batch number: 1412121) intramuscularly. It was reported that the patient received FLUVIRIN from open multiple dose vial (MDV) that reached 72 F overnight. No adverse event was reported following this medication error (incorrect storage of drug).
Patient woke up with chest pain that got worse as the day wore on, 8/10. Went to the ER at 2100 that night and had normal EKG per patient. Was told his chest pain was related to heartburn from taking OTC NSAIDS for treatment of his robust take which had been phone triaged on 7/2/09 by facility. Patient also c/o fatigue and decreased appetite. Symptoms: Dyspnea (shortness of breath) .
SICK; VOMITING A FEW TIMES; BEDRIDDEN FOR 3 DAYS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and 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 not reported, batch number: UNKNOWN, expiry: UNKNOWN) dose was not reported, administered on MAR-2021 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 sick. On MAR-2021, the subject experienced vomiting a few times. On MAR-2021, the subject experienced bedridden for 3 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bedridden for 3 days on MAR-2021, and the outcome of sick and vomiting a few times 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.
Patient received Fluzone HD on 10/23/2020 in left arm. One week later patient had pain in arm and could not lift arm.  She has been taking Tylenol.  She will be going to the physician.
Redness, inflammation, pain, hard lump on vaccine spot. Body soreness and headache. Multiple red blisters (about 30) all over body (head, face, arms, legs, chest, abdomen).
Coughing, abdominal pain, nausea, vomiting, diarrhea, headache, fatigue
fever and vesicular rash began 7-8 days after the vaccine; believed to be vaccine associated varicella
Patient developed a slight fever on the day after she received the shot but it broke by the next day. On the night of July 30 she developed another fever.  It rose to 103.5 on July 31 and on August 1 she developed a rash on her face and chest and her fever spiked to 104.8.  We were giving her Tylenol and Motrin switching every three hours throughout the 4 days but nothing seemed to break the fever.
The patient needed Polio, DTAP, and HIB. The provider opted to use the combination vaccination Pentacel. During the preparation of the Pentacel vaccine the DTAP and Polio component was drawn up but not combined with the HIB component. The patient was then administered the DTAP and Polio only. The patient's guardian was notified that the patient is missing the HIB component of vaccination. The patient has been scheduled for June 30, 2023 to receive the missing HIB vaccination.
headaches; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) and MYALGIA (body aches) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A214) for COVID-19 vaccination.     Concurrent medical conditions included Pre-diabetes. Concomitant products included METFORMIN for Pre-diabetes.    On 18-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced HEADACHE (headaches) and MYALGIA (body aches). At the time of the report, HEADACHE (headaches) and MYALGIA (body aches) outcome was unknown. Not Provided          Patient wanted to \know if she could take Tylenol  No treatment information was provided. ? The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the mRNA-1273 in response to the events was not applicable. ? Action taken with mRNA-1273 in response to the event was not applicable.
This case was reported by a consumer and described the occurrence of a swollen arm in a 5 year old male subject who was vaccinated with Infanrix, plus a separate injection of hepatitis A vaccine. The reporter is the mother of the subject. A physician or other health care professional has not verified this report. On 7/13/05, the subject received the 5th dose of Infanrix in the right arm (lot AC14A009BA) and a dose of hepatitis A vaccine (dose number and site of injection not provided). On 7/13/05, the subject also received MMRII and IPOL and a tuberculin skin test. The administration sites for the MMRII, IPOL and tuberculin skin test, the consumer stated that the subject experienced "swelling and redness of the entire right arm", and that the arm was "hot to touch and itching". The consumer also stated that the subject, "experienced a fever of 101F that comes and goes and restlessness". The subject was seen at a physician's office and an ER. The events had improved at the time of initial reporting, 7/19/05.
PATIENT REPORTED THAT SHE WOKE UP FEELING ILL ON SATURDAY 11/28 AND THEN  DEVELOPED CHILLS ON SUNDAY 11/29  WHILE DRIVING. SHE HAD TO PULL OVER TO THE  SIDE OF THE ROAD AND LATER SHE THREW UP. SHE BELIEVES THIS TO BE FROM HER FLU VACCINATION FRIDAY EVENING.
upset stomach; no apatite; felt terrible; swelling at the site of injection; headache; joint pain; chills; muscle pain; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), DECREASED APPETITE (no apatite), MALAISE (felt terrible), VACCINATION SITE SWELLING (swelling at the site of injection) and HEADACHE (headache) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 19-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), DECREASED APPETITE (no apatite), MALAISE (felt terrible), VACCINATION SITE SWELLING (swelling at the site of injection), HEADACHE (headache), ARTHRALGIA (joint pain), CHILLS (chills), MYALGIA (muscle pain) and FATIGUE (fatigue). At the time of the report, ABDOMINAL DISCOMFORT (upset stomach), DECREASED APPETITE (no apatite), MALAISE (felt terrible), VACCINATION SITE SWELLING (swelling at the site of injection), HEADACHE (headache), ARTHRALGIA (joint pain), CHILLS (chills), MYALGIA (muscle pain) and FATIGUE (fatigue) outcome was unknown.            No concomitant medication was reported , No treatment medication was reported . Follow-up received on 09-May-2021 included no new information   This case was linked to MOD-2021-051629 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 09-May-2021: TCR received on 9-may-2021, NNI was updated .
Nausea after taking pill.  Abdominal cramps after 4th pill - nausea / abdominal cramps occur sporadically now.
Numbness / tingling, pain, starting in left leg, occasionally left arm, then both legs.  Headaches daily Dizziness Severe fatigue Body aches
COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 09May2023 as dose 7 (booster), single (Lot number: GK1337), in right arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 4 (booster), single (Batch/Lot number: unknown), as dose 5 (booster), single (Batch/Lot number: unknown) and as dose 6 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Sulfonamide allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Codeine, reaction(s): "Drug hypersensitivity". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Sep2023, outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures (Paxlovid treatment start date: 16Sep2023, stop date: 21Sep2023) were taken as a result of drug ineffective, covid-19.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300335847 same patient, different drug and event;
Information has been received from a registered nurse concerning a patient who on 21-SEP-1999 was vaccinated with a dose of Varivax. Subsequently, on 23-MAR-2006, the patient developed breakthrough varicella. Unspecified medical attention was sought. There was no product quality complaint. No additional information is expected.