chrisvoncsefalvay/vaers-outcomes huggingface dataset:
12 year old received moderna dose as 2nd dose; 2 dose interchanged- got moderna instead of pfizer; wrong dosage used, 0.25 mL; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received moderna dose as 2nd dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 dose interchanged- got moderna instead of pfizer) and UNDERDOSE (wrong dosage used, 0.25 mL) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Dec-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received moderna dose as 2nd dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 dose interchanged- got moderna instead of pfizer) and UNDERDOSE (wrong dosage used, 0.25 mL). On 09-Dec-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (12 year old received moderna dose as 2nd dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2 dose interchanged- got moderna instead of pfizer) and UNDERDOSE (wrong dosage used, 0.25 mL) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.   No treatment information provided. Instead of receiving the Pfizer vaccine as 2nd dose, consumer was given a dose of Moderna covid-19. Expiration date was mentioned as  24 Mar 2021
Patient presented to the COVID clinic today January 14, 2020 for her first COVID-19 vaccine.  She was given 0.3 mls of the vaccine IM in the left deltoid.at 2:40 pm.  She pulled around to the observation area and at 2:45 she reported that she was experiencing her lips tingling along with chest pressure and SOB.  Spo2 was 96% on RA.  Oxygen applied via face mask at 4 L..  Sp02 then went up to 99%.  At 2:50 BP was 122/80.   At this time she reports that the chest pressure has subsided but that she was still experiencing some fuzziness in her eyes.  She denies any itching.  At 2:53 she reports that her lips are not as numb but that she still has some fizziness.  At 2:58 she reports that she feels "real tired" and that she is not as "fuzzy headed".  Patient continued to improve.  At 3:09 oxygen was removed.  Sp02 stayed at 98%.   After observing patient for several minutes she was found to be in stable condition to leave the observation unit.  She was agreeable to this plan.  She will notify her PCP with any further symptoms.
Per parent report, temp 103 for 2 days responded to Tylenol. Bright red rash everywhere. Sleepy. did not bring child in for appt. Child now fine.
Bad chills; tired; rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (rash at the injection site), CHILLS (Bad chills) and FATIGUE (tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced VACCINATION SITE RASH (rash at the injection site). On 06-Apr-2021, the patient experienced CHILLS (Bad chills) and FATIGUE (tired). At the time of the report, VACCINATION SITE RASH (rash at the injection site), CHILLS (Bad chills) and FATIGUE (tired) had resolved. Not Provided    The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   No concomitant medications specified. No treatment medication information was provided.
Lateral right upper arm red and swollen. Redness appear more like like allergic reaction. KEFLEX 500mg BID x7days; BENARDYL 50mg PRN. Skin infection.
Ramsay Hunt Syndrome; other zoster related injuries; Information has been received from a lawyer and a patient of unknown age and gender regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. On or about 30-OCT-2014, the patient was administered the zoster vaccine live (ZOSTAVAX) (strength, dose, lot# and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by healthcare providers for the following injuries resulting from zoster vaccine live (ZOSTAVAX): Ramsay Hunt Syndrome and other zoster related injuries. The outcome of the events was unknown. The causality assessment was considered as related by the lawyer.  Upon internal review, Ramsay Hunt Syndrome was determined to be medically significant.
This is in follow-up to report(s) previously submitted on 4/13/2007. Initial and follow up information has been received from a registered nurse, via a company representative, concerning the nurse's daughter, a 22 year old female patient, who on 19-JAN-2007 was vaccinated with the first dose, 0.5ml, IM, of GARDASIL (Lot# 654540/0800F). There was no concomitant medication. On 19-JAN-2007, beginning at 2:00pm, the patient "experienced numbness and tenderness around the injection site." The nurse reported that her daughter had a painful deltoid for eight weeks and that sometimes the pain woke her daughter up at night and continued for a month, and indicated that "contact with the area was extremely painful. There was no swelling or erythema." On 19-FEB-2007 (previously reported as 18-FEB-2007), the patient had recovered from the numbness and tenderness, and the second dose of GARDASIL was then administered without any problems. The patient sought unspecified medical attention. No further information is expected.
Vaccine administered after more than 1 temperature excursion; Vaccine 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 (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021 at 3:48 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 08-Feb-2021 at 3:48 PM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 41.40  . Concomitant products were not provided.  On 08-Feb-2021, Excursion time was 10 AM, 11AM temperature was 29, 35 total doses given for the day was 30, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 2-Feb-2021, vial was moved to clinic on 08-Feb-2021. 3 vials were sent to clinic. Vaccine BUD date was 4-Mar-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 brand traceable temperature monitor at every hour.  After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F.  Treatment medications were not reported.
My arm swelled, sore, painful huge lump in the arm the size of a tennis ball.  Require to take prednisone to aid.  Still have a hard lump in my right arm.
Headache, the headache that I have come in for several months now is still unrelenting. It is very difficult to get myself to do things because it constantly there. It started after the covid vaccine, that night it was terrible and the next day. Then it has just stayed, mostly a low grade headache, with some days worse. It can be worse in the afternoon, evening or sometime upon waking in the morning.  But I am never free of it.  Swollen lymph nodes under my chin.  They would become painful and throb at times.   Having a pounding and fast heart beat. I can be sitting, standing, trying to go to sleep and it just goes. Hard to fall asleep with this jack hammer going.   Feeling hot and sweating 24/7, along with a tightness across the chest.  Isn't painful, just tight.  Some dizziness.  Had one episode of suddenly losing  my vision.  I felt very dizzy. It took a good several minutes to recover.   Pain going up the right side of my neck and check, from clavicle up to the eye. I have noticed more right side neck pain that comes and goes.   All the while, low energy and fatigue,  and my blood pressure has become abnormal.  I have had high blood pressure, up to 180/120, over the last 6 months.  Ischemic event in January 2022, had a ct scan and shows an injury in the left lobe.
Moderna COVID-19 vaccine EUA: Chills, sore throat, headache, body aches, fatigue. Shot site swollen, red and painful started two days after shot..
Patient experienced an itchy rash on her arms and legs, along with underarm soreness in the area of her lymph nodes.
1 day post vax developed fever 103 & scarlatiniform rash; Following day developed Stevens Johnson Synd & was in ICU for 2 wks;
After one week or so past my vaccination I had become extremely fatigued with no energy. On August 2022 I contracted the COVID-19 virus. I woke up and my whole body hurt, my skin felt like it was being pricked and all of my joints hurt. I had a horrific cough I had coughing and wheezing, I was insanely nauseous and actually fainted. Due to having had the vaccines I did not believe I had COVID-19. On the second day I had identical symptoms only worse and I now lost taste and smell. An antiviral medication was prescribed; molnupiravir and began taking this prescription on the fourth day of my sickness, it was a seven day course. By Wednesday of the following week at 11/10/2022 tested for COVID-19 again and although negative I still carried all the symptoms eventually within two weeks symptoms subsided except for taste and smell which remained or I was still unable to taste or smell still.
itchy, red rash at injection site. An attack of angioedema in my face, both sides of mouth, cheeks, jaw
A report has been received from a Physician concerning a 7 year old, Female subject, Height: 49.0 inches; Weight: 48.0 Kilograms, who had been receiving FLUMIST quadrivalent (intranasal). FLUMIST quadrivalent (intranasal) started on 30-Sep-2013. It was reported that when Licensed practical nurse was giving FLUMIST the patient moved and some went in the eyes of patient on 30-Sep-2013. The outcome of the event went in the eye is unknown. The report was considered to be non-serious.
Patient stated that she felt a little dizzy after the shot, but often happens with Flu shots. About 2 hours after receiving the shot, she felt severe lower back pain on her left side (shot given in right arm).  Feels like a knot and is sensitive to the touch. Injection site looks fine, no swelling or redness.
Development of severe tongue pain followed by bilateral hand pain, with subsequent development of petechiae in the terminal tufts of the hands.  The tongue and hand pain subsided after 48 hours.  Petechiae lasted for weeks.  This was likely a mild manifestation of serum sickness.  I had numerous physicians examine me including an Infectious Disease expert.
pt was given her 1st dose ~9:33am on 4/14/21. while sitting and waiting for the observance period, pt became hot, sweaty, dizzy and fainted at 9:45am.  pt came to and was trying to get up right as we were coming to her aid.  pt was given an ice pack and placed in upright position and monitored for another 15 to 20 mins until family could come pick her up.
Patient received the covid vaccine on 01/05/2021. c/o new onset fever of 101.2, fatigue, headache, and body ache. Denies cough, sore throat, any ocular or GI symptoms.  Covid test on 12/3/2020 was positive.
Approximately 6 hours after vaccination, patient ran temperature of less than 103 in spite of Tylenol every four hours. Crying hysterically, falling asleep for 10-15 minutes then crying again.
5/10 CHEST PAIN, TROUBLE BREATHING, SEEN BY PARAMADICS, VSS, PROVIDED WITH WATER, SYMPTOMS IMPROVED, REFUSED TRANSPORT, AMA SIGNED.
Presents at ER with 103.2 temp and some red papules with dew drop lesions
Two weeks after the vaccine I began to have irregular periods.  Two months later, I completely missed a period and had elevated DHEAS and prolactin levels.  Both lasted for five months.  No treatment except to monitor symptoms.
This spontaneous report was received from a medical assistant, referring to two unspecified patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 with a Lot # L014415 and an expiration date of 25-JUL-2017 (strength, dose and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccine was exposed to temperature of 32 Fahrenheit degrees (°F) to 35 °F for a time frame of 35 days and 4 hours. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccine. There was no product quality complaint involved. Additional information has been requested.
two times patient experienced fever and chills with the vaccine; two times patient experienced fever and chills with the vaccine; This spontaneous case was reported by a patient and describes the occurrence of PYREXIA (two times patient experienced fever and chills with the vaccine) and CHILLS (two times patient experienced fever and chills with the vaccine) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Relapsing multiple sclerosis and Seasonal allergy. Concomitant products included OCRELIZUMAB (OCREVUS), COVID-19 VACCINE and NIRMATRELVIR, RITONAVIR (PAXLOVID) for an unknown indication.   On 19-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 PYREXIA (two times patient experienced fever and chills with the vaccine) and CHILLS (two times patient experienced fever and chills with the vaccine). At the time of the report, PYREXIA (two times patient experienced fever and chills with the vaccine) and CHILLS (two times patient experienced fever and chills with the vaccine) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   Reportedly, on 10-Apr-2021, 28-Oct-2021 and 28-Sep-2022 patient received other doses of the vaccine.  It was reported that patient did not have assessment of her immune response to the  vaccine but tolerated the shots well. Additionally patient also reported that out of the four vaccinations patient had two times experienced fever and chills with the vaccine which resolved overnight and not further clarified by patient on which two dates the vaccination gave her fever and chills.  Treatment details were not reported by the reporter.
Got vaccinated now and she has a heart problem; Got vaccinated now and she has a heart problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CARDIAC OPERATION (medically significant), CARDIAC DISORDER (non-serious), outcome "unknown" and all described as "Got vaccinated now and she has a heart problem". Therapeutic measures were taken as a result of cardiac operation, cardiac disorder.  Addition information: She is calling about the Pfizer Covid Vaccine (Clarified as Pfizer COVID-19 Vaccine) because she mention that her mom got vaccinated now and she has a heart problem. I mean her heart surgery and they want to know if what is the risk does she have for getting the vaccine and the Pfizer Medical Information is already closed at this time, I decided to connect the caller since she is calling on h of her mom. She have, because she had a heart surgery. She wants to know what the risk are.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Dizziness, Throwing up, nausea, headache, weak, muscle aches, diarrhea , no energy, sleeping more, flu like feeling; All symptoms kept for the week and still have them 5 days later.  Loss of appetite as well.  Monday and Thursday of the week was only time of throwing up.
4 DAYS IN A ROW:  NEARLY CONTINUOUS HEADACHE, EXTREME SLEEPINESS (RESULTING IN 1 HOUR "ANP").  FOR 2 DAYS:  AT TIMES DIFFICULTY FOCUSING.  7 DAYS: SORE LEFT ARM.
Patient who was administered a 2-dose series of V ARIV AX "as a child" had titers drawn "recently" which were negative for immunity to varicella.; This spontaneous report was received from a healthcare professional (Medical assistant) via office manager refers to a female patient of around 20 years old. The patient's concurrent conditions, medical history and concomitant medications were not provided. The patient had allergy with many foods. On an unknown date, the patient was vaccinated with 2-dose series of varicella virus vaccine live (oka/merck)(VARIVAX) as child for immunity of varicella (prophylaxis) (strength, dose, lot number, expiry date unspecified). Other suspect therapies included sterile diluent (STERILE DILUENT)(strength, dose, lot number, expiry date unspecified). On an unknown date in 2019 (reported as recently), the patient had titers down recently which were negative for immunity to varicella (antibody test negative). As a result, patient was administered a third dose of varicella virus vaccine live (VARIVAX) on an unknown date in 2019 (reported as recently). No additional information provided. There was no treatment given for AE. There was no intervention to previous serious criteria. No cancer was diagnosed. No overdose. No PQC involved. The outcome of antibody test negative was unknown. Reporter's causality was not provided.
time course given as time after shot (i.e. "at 6 hrs" means 6 hours after I received the vaccine)  at 6 hrs: mild headache, fatigue at 10 hrs: moderate headache, chills, fatigue at 15 hrs: moderate/severe headache, chills, fatigue, fever at 22 hrs: headache, fatigue at 28 hrs: mild headache, mild fatigue
Pain/pain all over body; Nausea; Swollen glands in both sides of the jaw/swollen lymph node; Arthritis; Fibromyalgia; Lump inside of left arm just below elbow crease and another one on the inside of left leg upper thigh; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen glands in both sides of the jaw/swollen lymph node), ARTHRITIS (Arthritis), FIBROMYALGIA (Fibromyalgia), MASS (Lump inside of left arm just below elbow crease and another one on the inside of left leg upper thigh) and PAIN (Pain/pain all over body) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009D21A and 033B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Pain/pain all over body). In June 2021, the patient experienced LYMPHADENOPATHY (Swollen glands in both sides of the jaw/swollen lymph node), ARTHRITIS (Arthritis), FIBROMYALGIA (Fibromyalgia), MASS (Lump inside of left arm just below elbow crease and another one on the inside of left leg upper thigh) and NAUSEA (Nausea). At the time of the report, LYMPHADENOPATHY (Swollen glands in both sides of the jaw/swollen lymph node), ARTHRITIS (Arthritis), FIBROMYALGIA (Fibromyalgia), MASS (Lump inside of left arm just below elbow crease and another one on the inside of left leg upper thigh), PAIN (Pain/pain all over body) and NAUSEA (Nausea) outcome was unknown.            Concomitant medications and medical history details are not provided by the Reporter.  No treatment information is provided.   The action taken for m-RNA-1273 Covid-19 Moderna Vaccine was not applicable.   This case was linked to MOD-2021-222076 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up received on 15-Jun-2021 included additional events
COVID; COVID; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 46-year-old male patient received BNT162b2 (BNT162B2), on 15Dec2021 at 12:00 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 46 years, in left arm for COVID-19 immunisation; COVID-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for COVID-19 immunisation. The patient's relevant medical history included: "Obesity" (unspecified if ongoing); "Sleep apnea" (unspecified if ongoing); "Kidney stones" (unspecified if ongoing); "Known allergies: Yes, penicillin" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, COVID-19 including PF-07321332 (PAXLOVID).  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Exactly 7 days after the vaccine, Neck was hurting when I woke up, I thought I had slept wrong. My shoulders were really stiff, and I went to the mirror and started touching the sore parts and there were a bunch of knots all along my neck and shoulder blade along the left side. My Primary care doctor was unavailable, so I went to my allergist to make sure it wasn't an allergic reaction. I can't remember exactly but I think she just told me to take some Tylenol, and that it would go down. She suspected it was from the vaccine because her coworker had lymph node swelling in her armpit Then she sent me to my ENT the next day because I couldn't get an appt with my PC. I don't think she told me to do anything. I wasn't able to see my regular doctor until about a week later. I don't remember what my PC said, but it took almost a month for the swelling to go down.
urticarial rash w/in 3 hrs of vax; improved w/DPH; booster dose;