chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Swelling behind my ear, near my hairline; Swelling behind myear, near my hairline was sore for 3 days; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling behind my ear, near my hairline) and PAIN (Swelling behind myear, near my hairline was sore for 3 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     The patient's past medical history included Defibrillator/pacemaker insertion. Concurrent medical conditions included Heart disease, unspecified. Concomitant products included ATORVASTATIN for Cholesterol, ACETYLSALICYLIC ACID (BABY ASPIRIN), METOPROLOL, LEVOTHYROXINE SODIUM (LEVOTHYROXIN) and LOSARTAN for an unknown indication.    On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced SWELLING (Swelling behind my ear, near my hairline) and PAIN (Swelling behind myear, near my hairline was sore for 3 days). In April 2021, SWELLING (Swelling behind my ear, near my hairline) and PAIN (Swelling behind myear, near my hairline was sore for 3 days) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Treatment medication was provided.   This case was linked to MOD-2021-211622 (Patient Link).
Apparently fainted 10-12 minutes after receiving vaccines. Had 2 to 3 myoclonic jerks of trunk and arms - nothing sustained. Laid down for 20 mins. - then sat for 10 more - initially received oxygen. Had juice box - stable after 30 mins.
administered 0.25 ml instead of 0.5 ml to uncompromised adults/wrong dose for Bivalent Vaccine booster dose (underdose); No adverse event; This spontaneous case was reported by a physician and describes the occurrence of ACCIDENTAL UNDERDOSE (administered 0.25 ml instead of 0.5 ml to uncompromised adults/wrong dose for Bivalent Vaccine booster dose (underdose)) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On an unknown date, the patient experienced ACCIDENTAL UNDERDOSE (administered 0.25 ml instead of 0.5 ml to uncompromised adults/wrong dose for Bivalent Vaccine booster dose (underdose)) and NO ADVERSE EVENT (No adverse event). At the time of the report, ACCIDENTAL UNDERDOSE (administered 0.25 ml instead of 0.5 ml to uncompromised adults/wrong dose for Bivalent Vaccine booster dose (underdose)) 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 ACCIDENTAL UNDERDOSE (administered 0.25 ml instead of 0.5 ml to uncompromised adults/wrong dose for Bivalent Vaccine booster dose (underdose)).    Concomitant medications were not reported.   They reported approximately 100 patients were administered lower than authorized dose of the Moderna COVID-19 bivalent booster. It was reported when first administering Bivalent boosters. So, they assumed the same dose as the second booster, and they were administering 0.25 ml instead of 0.5 ml to uncompromised adults. It was reported that no adverse event was reported.  Treatment medications were not reported.
Patient passed out at the restaurant inside store several minutes after receiving the vaccine.  Patient fell and hit her head and has a goose egg on her head.
The pts mother called reporting that the child woke up vomiting and complained of headache, chills, epigastric discomfort and vomiting. Denies fever or other complaints.
After I was administered the first Moderna vaccine at Walgreens, I sat in a chair to wait the recommended 15 minutes. Between 1-3 minutes after, I began to get nauseous and dizzy and then I got a severe headache. I lost control over my body and the papers the nurse had given me slipped out of my hand and the water bottle I was holding fell to the ground. I got extremely hot and started sweating. My mother noticed and alerted the pharmacy I was having a reaction. From what I remember they paged something overhead and I started feeling worse going deep within myself and very removed from the situation. My heart felt abnormal and there was tingling and pain in my head. I could barely communicate and thought I was either dying or was going to have to be wheeled out in a stretcher. Although I couldn't open my eyes or really communicate, I felt the nurse touch me and say I was really hot. She told me to get to the floor. I slid to the floor and someone got a dog bed to put under my head. I started to feel better after about a minute, although I had to just lie there for a few minutes before I could really communicate again.  I then began to get chills and shiver.  They got me water and I asked for a straw because I didn't have the energy to lift my head. I was able to sit up (on the floor still) after about 5 minutes. My mother had called my dad and we waited for him to come to the store so he could help me to the car. has preserved video of the incident. I also have the names of the nurse who treated me, the manager, and the Walgreens pharmacy manager (and my mother who was there) who are all willing to attest to the incident. I felt sick for 9 days - headache, fatigue, nauseous, dizziness (and one episode of diarrhea on the seventh day).  The seventh day was the worst for dizziness and nausea too.  My arm hurt for 5 days.
High and uncontrollable blood pressure, pain and pressure in head and ears, ongoing headache, and the worst headache of my life that lasted around 1 minute and caused serious disorientation.
Red circle around injection sites pain on arm red to touch swollen lymp gland in armpit headache and body ache and tiredness.
Patient received a TDAP vaccine at visit today that wasn't needed. He had previously received a TDAP vaccine on 09/17/07. This was missed during chart prep. Patient is a 64 y/o male w/ dx of BPH, schizophrenia, low back pain, HTN, and hip pain.
Nausea; Severe headache; Body/joint aches; Body/joint aches; This is a spontaneous report from a contactable healthcare professional (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL4238; Expiration date was not reported) on 25Jan2021 (14:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. Medical history included hypertension (HTN), asthma and allergies. The patient had unspecified concomitant medications. The patient was not pregnant at the time of vaccination. On 26Jan2021 (09:00), the patient had nausea; severe headache; and body/joint aches. The patient did not receive any treatment for the reported events. The outcome of the events, nausea, severe headache and body/joint aches, was recovered in Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.
Vaccination site erythema; Vaccination site swelling; Tiredness; vaccination site pain; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (Tiredness), VACCINATION SITE PAIN (vaccination site pain), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced FATIGUE (Tiredness) and VACCINATION SITE PAIN (vaccination site pain). On 29-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling). At the time of the report, FATIGUE (Tiredness), VACCINATION SITE PAIN (vaccination site pain), VACCINATION SITE ERYTHEMA (Vaccination site erythema) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.
Pt developed tingling, heart racing, and flushing several minutes after injection. HR 120 BP 150/80, SP02 99%. No signs to suggest anaphylaxis. Symptoms improved after several minutes without intervention. Repeat HR 90. EMS services were not required and pt drove home.
Donor reported at center increasing pain and tenderness to left arm around puncture site 7 days after Tetanus vaccination.
Five days post vax, pt experienced pain and cramping in feet (which resolved) and pain in her back and hip joints. Other joints (nos) were starting to hurt. She has been unable to get out of bed since 03/05/00. She was treated with Advil. The vaccinee denies injury. She worked out with a personal trainer 3 times weekly. She reported these events after seeing a television show about
Information has been received from a physician via company representative referring to a male patient of unknown age. There was no concurrent condition or medical history reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dosage, strength, route and lot # unknown) for prevention of shingles. There was no concomitant medication reported. While on ZOSTAVAX, the patient developed shingles. The patient visited the physician for medical attention. The outcome of the event was unknown. Additional information is not expected as the reporter did not wish further contact.
Moderna Arm      3 inch diameter fine rash started 12 days after vaccine.  It started just beside the injection site.  Grew to an oval raised red area about 5 inches long.  Warm to touch with mild edema.  Day 5 -now it is a red oval outline about 5 inches long  with a smaller rash at the bottom.  It is only slightly itchy.  No Need for meds so far.
Patient said the evening of the vaccines that her face started to swell including the bottom eye and her neck and she had diarrhea.  No trouble breathing. She said it lasted for 3 days and it went away
Dizziness and passed out twice in a matter of 15 minutes. Fatigue day after.
administered Moderna Covid 19 Bivalent after 30 day use by date; No Adverse Event; administered Moderna Covid 19 Bivalent after 30 day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date), PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No Adverse Event) in an adult patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 13-Dec-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 13-Dec-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date), PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (administered Moderna Covid 19 Bivalent after 30 day use by date) and PRODUCT STORAGE ERROR (administered Moderna Covid 19 Bivalent after 30 day use by date).    No concomitant medication information provided.  It was reported that HCP had called to inform that 4 or 5 adult patients were accidentally administered Moderna COVID-19 Bivalent after 30 day use by date.  No treatment information provided.   This case was linked to MOD-2022-687538, MOD-2022-687539, MOD-2022-687540, MOD-2022-687454, MOD-2022-687542 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 14-Dec-2022: Upon internal review on 20-Jan-2023, significant correction was performed to update the Worldwide unique case identification number.; Sender's Comments:  MOD-2022-687454:Original Case : MOD-2022-687454 MOD-2022-687540:Original Case : MOD-2022-687454 MOD-2022-687539:Original Case : MOD-2022-687454 MOD-2022-687542:Original Case : MOD-2022-687454 MOD-2022-687538:Original Case : MOD-2022-687454
This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039F21A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses given after temperature excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (temperature excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication was reported.     No treatment medications were reported.
TACHYCARDIA, NAUSEA STARTING APPROXIMATELY 10 MINUTES AFTER ADMINISTRATION OF THE 2ND DOSE. ALSO EXPERIENCED TREMORS GENERALIZED BUT WORSE IN HER HANDS WHICH STARTED APPROXIMATELY 25 MINUTES AFTER INJECTION OF COVID-19 (PFIZER) VACCINE.
This spontaneous report as received from a healthcare worker 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 23-NOV-2015, the patient was inadvertently administered an expired dose of VAQTA 25/0.5 (units not provided) lot # K008984, expiration date 21-OCT-2015 (dose and route of administration were not reported). There was no adverse effect reported. Additional information has been requested.
So weak could not turn in bed, hands went fuzzy, stabbing pains developed in hands, Hospitalized 4 days to treat bacterial infection, did MRI of brain, went to rehab for 6 weeks to learn to walk again and gain use of hands.  Now is diagnosed with either Guillen-Barre Syndrome or CIDP.  Neurologist is not certain which it is but is beginning infusions beginning Aug2 thru Aug6 to help her.
sharp chest pains with heart flutter,   shortness of breath for about 2 weeks    tingling like pins and numbness in feet and hands  still continues on and off today
Swollen, red injection site and in arm vaccine was administered in. Patient referred to her doctor's office for follow up.
Shingles rash; This spontaneous case was reported by a nurse and describes the occurrence of HERPES ZOSTER (Shingles rash) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced HERPES ZOSTER (Shingles rash). At the time of the report, HERPES ZOSTER (Shingles rash) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.  No concomitant medication was provided.
08/29/2022  in the evening I started feeling achy and had a temperature. I did 2  home test in the evening and 2 home test the next day on 08/30/2022 my result were negative. I still wasn't feeling well so I went to the urgent care I got a COVID-19 test which was actually was positive. I went home I set up  a tele health with my doctor. After my tele health my doctor prescribed me with Paxlovid for 5 days. I started taking my medication as soon as I received them . I didn't leave home for 8 days just to be safe. As of today 10/06/2022 I feel better but less energy then before.
Pt. got vaccine in AM Sept. 23. Show up in Pharmacy at 9 AM Sept. 24 with red, swollen bicep muscle. Pt. complains of pain on the arm pit through the breast area of the (R) arm. Tell pt. to take TYLENOL and ibuprofen and BENADRYL. Talked to pt. at 12 PM Sept. 24 - pt. felt better. Talked to pt. at 9 AM Sept. 25 - pt. said only a little bit of pain and swelling. Pt. felt much better.
blood sugar dropped; UTI; Sore arm; extreme fatigue; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of MYALGIA (Sore arm), the second episode of MYALGIA (Sore arm), BLOOD GLUCOSE DECREASED (blood sugar dropped), FATIGUE (extreme fatigue) and URINARY TRACT INFECTION (UTI) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jan-2021, the patient experienced the first episode of MYALGIA (Sore arm). On 01-Feb-2021, the patient experienced the second episode of MYALGIA (Sore arm), BLOOD GLUCOSE DECREASED (blood sugar dropped), FATIGUE (extreme fatigue) and URINARY TRACT INFECTION (UTI). At the time of the report, BLOOD GLUCOSE DECREASED (blood sugar dropped), FATIGUE (extreme fatigue) and URINARY TRACT INFECTION (UTI) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-036316 (Linked Report). This case was linked to MOD-2021-035704 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-036316:
The patient received a flu shot on Monday 09/27/21 at approx 12:35pm.  The patient came thru the drive thru at approx 12:50 to complain of arm pain from the shot, but only wanted to let me know.  I apologized and asked if there was anything I could do for her.  She said not at this time.  I asked her to let me know if there was anything that changed.  The patient returned to the store on Tuesday 09/28/2021 at approx 1pm to show me the bruise on her upper arm near her shoulder and to report pain at that site and extending up to her neck.   I sincerely apologized and told her we would be reporting the incident and asked if there was anything I could do for her.  She declined any care.
SWOLLEN TONGUE AND THROAT, HIGH BLOOD PRESSURE,  FAST HEART RATE, TINGLING IN FACE
Sedation, Myalgia, Arthralgia, Fever, Chills, Redness/swelling @injection site Narrative:
Fever - 100.8 and kept rising to 103.9 - continued through out day and into the night of 06/06/15. Gave Ibuprofen for fever. Inconsolable crying. Moaning- Lethargic- crying out in pain. Throwing up. Coughing. 06/06/15- Went to Doctor on 06/06/15- Recommended to just manage fever.  Fever-and pain still present 06/07/15.
Fever 102.9 and redness at injection site, H/A with nausea.
patient contacted pharmacy on 4/27/21 regarding severe bruising and muscle pain on anterior (bicep) of arm.  patient had to call into work due to severe muscle pain in left arm.  upon inspection patient had severe bruising on inside of arm, lower bicept progressing through elbow and down to lower arm.  patient stated today felt better and pain was resolving but had severe pain 3 days prior
Redness, swelling, fever, and pain at injection site for greater than 48 hours.  Chills, fever, body aches, headache, flu-like symptoms, lose of appetite, general malaise.
Patient developed a rash on the right arm. She went to the doctor and was prescribed a cream and Hydroxyzine. Symptoms have improved.
This spontaneous report as received from a physician refers to a 7 year old patient of unknown gender. On 05-DEC-2014 this 7 year old patient was vaccinated with a dose of GARDASIL (lot# not reported, 0.5 ml/once, intramuscularly). Concomitant medications were not provided. No adverse effect was reported. Additional information has been requested.
Information has been received from a physician concerning a patient who was age 10 and up both female and male, who on unspecified dates were vaccinated RECOMBIVAX HB (manufacturer unknown) (Lot # unknown) and tested negative titer for Hep B. Follow up information has been received from an office manager and a physician concerning a 16 year old male patient who on 19-APR-1994 and 17-NOV-1994 was vaccinated with the second and third doses of RECOMBIVAX HB (lot number 607881/0941W, T-cont, in the right leg for the second dose and lot number 611290/0048A in the left arm for the third dose). On 15-FEB-1994, the first dose of RECOMBIVAX HB (manufacturer unknown) was administered. Concomitant vaccines included: DTP (manufacturer Connaught) administered on 19-APR-1994 (lot number 3D51083, in the left leg); OPV (manufacturer leaderle) administered on 19-APR-1994 (lot number 368-949-0698D, orally); Hib conj vaccine (tet toxoid) (manufacturer Praxis) administered on 19-APR-1994 (lot number MOO5KD), in the right leg). Patient had initial Hepatitis B series and was no longer immune per blood test titers. The patient was appointed to start the second series on 18-AUG-2010. Past drug history included: GARDASIL (manufacturer Sanofi) administered on 03-JUL-2007 in the left arm and on 19-JUL-2010 in the left arm; Hib conj vaccine (tet toxoid) (manufacturer Praxis) administered on 17-MAY-1995 (lot number M315LE) in the right arm; DTP (manufacturer Connaught) administered on 22-JUN-1994 (lot number 3E51112, in the left arm) and 18-AUG-1994 (lot number 4H51508, in the left arm); DTAP (manufacturer Leaderle) administered on 23-AUG-1995 (lot number 378-909) in the left arm and on 23-FEB-1999 DTAP (manufacturer Connaught) (lot number 0970140) in the left arm; BOOSTRIX administered on 17-JUL-2006 in the left arm; Hib conj vaccine (tet toxoid) (manufacturer Praxis) administered on 22-JUN-1994 (lot number M460LA, in the right leg) and 18-AUG-1994 (lot number M28543, in the right leg); MMR II administered on 19-FEB-1995 (lot number 1708W-0889A) in the left arm and on 23-FEB-1999 (lot number 628903/1359H) in the right arm; OPV (manufacturer Leaderle) administered on 23-AUG-1995 (lot number 396-925-0717A) and on 23-FEB-1999 (lot number 057-839-0795E) and on 22-JUN-1994 (lot number 368-949-0698D, orally); VARIVAX (Merck) administered on 05-DEC-1995 (lot number 610257/0750B, in the left arm) and on 29-JUL-2008 (lot number 659456/1912U, in the left arm). This is one of several reports from the same source. Additional information has been requested.
Pt was inadvertently given additional bivalent booster, previously received on 10/12/22