chrisvoncsefalvay/vaers-outcomes huggingface dataset:
injection site itching; Site of injection has red mark; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Mar-2021 and was forwarded to Moderna on 01-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (injection site itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-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 27-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (injection site itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark). At the time of the report, VACCINATION SITE PRURITUS (injection site itching) and VACCINATION SITE ERYTHEMA (Site of injection has red mark) outcome was unknown.            Reporter did not allow further contact
Patient having worsening tingling and numbness of hands and feet. Patient also having  weakness of all extremities
15 cm x 12 cm area erythema, tenderness and mild swelling Rt upper arm. Fever 101.5. Treatment: cool compresses, TYLENOL or ibuprofen.
Daughter received the booster dose while being pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Daughter received the booster dose while being pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Daughter received the booster dose while being pregnant). At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (Daughter received the booster dose while being pregnant) had resolved.            No concomitant and treatment medication were reported.  The reporter wanted to know why in the  it was mentioned that patients should tell if they are pregnant as the reporter's daughter received the booster dose while being pregnant.
Panicking; Rash all over/ red patch all over her chest; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Rash all over/ red patch all over her chest) and PANIC REACTION (Panicking) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 07-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced RASH ERYTHEMATOUS (Rash all over/ red patch all over her chest). On an unknown date, the patient experienced PANIC REACTION (Panicking). At the time of the report, RASH ERYTHEMATOUS (Rash all over/ red patch all over her chest) and PANIC REACTION (Panicking) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment details were provided.
it is scaring the caller; shoulder hurt/joint pains in both legs; This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection), via an unspecified route of administration on May2021 (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The medical history and concomitant medications were not reported. On May2021 the patient experienced shoulder hurt/joint pains in both legs. On an unknown date the patient experienced it is scaring the caller. The patient stated that she got her vaccine a week ago and it was fine. The shoulder hurt, it's okay it doesn't bother her. 3 days after, the patient started to have joint pains in both legs and its growing and growing. The patient has to sit or go to bed every one hour. The patient is healthy. All of the doctors don't know what to do. The caller read online and saw that people who had this now cannot walk. This is a weird response of the body and it is scaring the patient. The patient wanted to know what she should do or if she needs to go to a specialist or get blood work done or what. The outcome of both the events was unknown.
I have had swimmers ear a lot in the past, but after going to the dr. it is not swimmers ear. The right ear has a lot of moisture, and slight itching. Referred to ENT on 08/02/2021.
Beginning at 2130 hrs- temp 104.3; chills, sore throat and ears, abdominal discomfort with bloating.  Sore left shoulder at the injection site for a week.  Alternated take Tylenol and Advil every 4 hours for two days.
sore arm initially; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm initially) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 15-Nov-2020.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced PAIN IN EXTREMITY (sore arm initially). At the time of the report, PAIN IN EXTREMITY (sore arm initially) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Nov-2020, SARS-CoV-2 test: positive (Positive) Positive. In December 2020, SARS-CoV-2 test: positive (Positive) Positive.     mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medications were reported. No Treatment medications were reported. Patient at work started exp symptoms flu like sx fever, congestion,sore throat, headache, slight fever 17nov2020, dec2020 still positive.   This case was linked to MOD-2022-450431 (Patient Link).
Shortness breath, claustrophobic feeling, fever.  Was diagnosed with bronchitis.  Diagnosed with a flutter from cardiologist.  Has been back and forth to the doctor since the second vaccination.
patient stated had pain immediately upon injection (not abnormal amount, similar to other vaccines), arm started out sore like after other vaccines, but later that night pain continued to spread down to the elbow.  since that day has had pain in the muscle from shoulder to elbow.  also reported at one point in the last month he hit his hand and felt intense pain shoot up his arm so painful he felt sick to his stomach.  has an appointment with his PCP january 10 for follow up.
9:30 Fell asleep after shot. 10:30T hen he was very fussy, 1:00 irritable, legs hurt 5:00 very pale and would not eat 6:00 101 fever 2:00am 103.3 fever all night. Low grade fever all day. Still fussy.
COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) 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 and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Anti viral details, product=COVID 19 Treatment, brand=Pfizer, treatment start date=18Dec2022, indication=Treatment of COVID-19, administrator route Oral.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors, however a contributory role of the suspect drug to the reported events DRUG INEFFECTIVE and COVID 19 cannot be ruled out.
Red, warm to touch, sore, swollen 6cm. Zyrtec 10mg.
This spontaneous report as received from a pharmacist refers to a 69 year old male patient with high cholesterol. Patient had no other drug allergies. On 14-FEB-2014 the patient was vaccinated with ZOSTAVAX via 0.65 ml with lot # J007211 and expiry date 20-SEP-2014, (strength, dose number unknown) subcutaneously to prevent shingles. On 16-FEB-2014, last night patient developed a round red hot hard lump at the injection site. On 17-FEB-2014, patient called and informed the pharmacist via the phone and was instructed by pharmacist to apply ice. No laboratory test was performed. The outcome of developed a round red hot hard lump and the injection site was reported as not recovered/not resolved. No further information was provided. Additional information has been requested.
Left dizzy and lightheaded, nausea and vommiting was taken to ED for  treatment.
Fatigued - ache - temp. elevated 99-101.5. TYLENOL & Ibuprofen. Ice applied to injection  site - warm to touch. Hurt to raise arm above head. Denies previous pneumonia. Oct 10 resolved.
Headache, fever then chills, high soreness at injection site. Onset approximately 5hrs after vaccination. Headache, fever/chills resolved after 12hrs. Treated with OTC painkillers (Aspirin, Naproxen); Redness & continued pain at injection site, lethargy following 2 days; (possibly unrelated?) Sporadic muscle cramping in left hand on 3rd day. Not resolved; Pain at injection site milder, but still present day 4.
After administering the vaccine the Luer Lock needle fell off of the syringe. The nurse stated that a lot of vaccine ran down my arm and was not administered.
After my first booster on 11.23.21, two weeks after that, my hair started falling out in big clumps. Then it turned into a skin infection, and then it turned in to sirs and then it was after the last booster on 06.09.22 that it developed into sepsis and also bloodspots in both lungs. Er visit and Hospital stay both at Hospital.
Patient reports feeling shaky and extremely cold with chills. He reports that he could not hold the phone or thermometer. He reported that he lied down and woke up around 7 pm. He said he was fine this morning.
Nausea, photophobia,  numbness and tingling  left arm & left leg,  neck rigidity,  flushed, chills, lethargy, somnolence, difficulty breathing  Zofran, Oxygen,  1 liter LR  symptoms resolved after TX and approximately 3 hours
Patient states  a couple of days after receiving SHINGRIX, the left side of her face started to feel weird and painful near eye and nose. She started to notice redness around in her left eye the morning of 9/24. Referred patient to visit an urgent care facility.
Multiple episodes of vomiting 1.5 hours after vaccination, no other symptoms. Given benadryl IM. Normal exam in office. Observed for 30 minutes, tolerated nursing. Discharged home with close observation by parent.
This spontaneous report as received from a nurse refers to an unspecified number patients of unknown age and gender. On an unknown date in 2014 (reported as since 08-AUG-2014), the patient were vaccinated with VARIVAX (Merck) which was improperly stored, (strength, dose, lot numbers and route were not reported). No adverse effects were reported. Follow up information has been received 27-OCT-2014 from the registered nurse who stated that it will take some time to get the VARIVAX (Merck) information (patient identifiers, lot numbers, expiration dates and dates of vaccine administration) together and that she may send the information at a later time. Follow up information has been received on 13-NOV-2014 from the registered nurse concerning a patient (age range reported as 17, units not reported) of unknown gender. On 07-NOV-2014, the patient was vaccinated with a dose of VARIVAX (Merck) which was improperly stored (lot number K005180, expiration date 10-APR-2016; dose number, dose and route were not reported). The reporter stated that this was the information that they could find and provide and anything further would be much too difficult and time consuming due to their record keeping and tracking system. This is one of several reports received from the same reporter. Additional information is not expected because follow up has been obtained.
Tinnitus, constant for the past seven weeks, ongoing, currently on prednisone with some benefit
Left lat thigh swelling with faint erythema around injection site after immunizations also developed rash like fifths disease shortly after shots.
the patient received expired doses of Daptacel, no adverse event; Initial information was received on 04-Jun-2020 regarding an unsolicited valid non-serious case from a nurse   This case is linked to 2020SA147720 (same reporter)  This case involves a four-months-old female patient who was administered a dose of expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL] (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant vaccinations included a dose of HEPATITIS A VACCINE INACT (HAVRIX) and a dose of INFLUENZA VACCINE INACT SPLIT 3V (FLUARIX)  On 04-Feb-2020, the patient received a 0.5 ml dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE (lot C5367AA, expiry 30-Jan-2020) (frequency-once) via intramuscular route in right vastus lateralis for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance 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.
Numbness in neck on left side, left side was side vaccination was administered. Started shortly after vaccine was given. Numbness in neck traveling to jaw line. Also reporting a headache.
SWELLED UP TO TENNIS BALL SIZE, VERY ITCHY FOR TWO DAYS, HOT NIGHT OF DONATION.
Swelling, hot area to left arm. (vaccination site) 52mm/47mm.
196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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)) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) and NO ADVERSE EVENT (No adverse event). At the time of the report, UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent) 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 UNDERDOSE (196 patients received 0.25mL of Moderna Covid-19 Vaccine, Bivalent).    No concomitant drug information was provided.  It was unknown if the patient had received any other vaccine 4 weeks prior to COVID-19 vaccine.  No treatment drug information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-689916 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Dec-2022: Follow up received wherein the patient age group and narrative updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-689916:Master case
This spontaneous report has been received on 21-NOV-2014 from a nurse regarding doses of VARIVAX (Merck) and PROQUAD (Merck) (Reference MARRS # 1412USA004221) that were exposed to a supported temperature excursion on 15-NOV-2014 have been administered to unspecified patients on unspecified dates since this excursion on 15-NOV-2014. No adverse effect has been observed or reported. No additional information was provided. Additional information has been requested.
On the day of vaccination began chills and low fever.  The next day, extreme neck, shoulder and back pain followed by hives itching, nausea, and headache
Pt became hot, nauseated, clammy, loss of color in face, and somewhat confused. Pt was transferred to exam table to lay down, with cold cloth applied to head and feet up above heart. Pt was monitored by provider until she recovered fully. Pt took 5-10 minutes to recover from above symptomology. Pt's mom was told to follow up with this office with any concerns.
Patient received the J&J  vaccine on 8/14/2021, patient is 13 years old and this vaccine is not approved for persons <18 years old. No adverse reactions noted. Patient and parent educated on what to watch for and when to seek care.
Aches and pains throughout body, headache, felt feverish - but had no fever, exhaustion - stayed in bed for 5 days after vaccine and slept most of each day, skin hurt to touch all over body
Delayed onset 1/30 2021 (vaccination 1/22/2021)  red, swollen itchy rash (R) vaccinated arm; size about 5-6cm. Used anti-itch cream. Slowly resolving. "Covid arm"?
Pt. presents to office with redness inside upper L arm.  States, "increasing in size of redness, but was more painful yesterday" Redness = approx 6" x 8" Pt. started on KEFLEX 500mg BID x 7 days.
Fever 100.8F for approximately 24 hours beginning 8-9 hours after injection, no treatment was taken.  This also presented as body chills/shivering.  Body aches for 24+ hrs, no treatment.  Lack of appetite, not really nausea.
Patient has had tingling sensation on left arm since day of administration. Patient reported it today, two months after vaccines.
VS:  BP 110/69 P84 R12 T983.8F Patient presented for HEP A vaccination  with Mother. Patient vital signs all WNL. Per Mother, no previous hx of serious reactions to any vaccines.   Soon after administration, Pt stated she felt dizzy and fainted into Mother's arms standing in front of her. Pt still sitting on exam table. Parent and this Nurse attempted to awaken Pt by calling out to her, using alcohol near nostrils. Pt came back right away.  Pt began crying and shaky. Pt to be observed another 15 to 20 minutes. Mother agreed.  Pt again began to faint, lose conscienceness. We began to call to her again and apply more alcohol near her nostrils. Pt awoke again. This Nurse asked Parent again if Pt had ever experienced these reactions before. Mother denied any hx of fainting with vaccine administration. While speaking with Parent, Pt once again fainted.  This Nurse recommended to Mother to call 911 for assistance since she had fainted three times. Mother agreed and 911 called at 11:15 am. This Nurse rechecked BP again and reading was much lower than baseline (88/58).  EMT's arrived at 11:30am. Patient did not have any more fainting episodes. Per EMT's Pt's vital signs all WNL and Pt AO x3.  Paramedic checked heart rhythm by EKG and WNL. Mother declined transport to ER from paramedic. Patient was able to walk out of clinic on her own with Mother. Mother instructed to call 911 or go to nearest ER/UC if SX return.
I COUNSELED PATIENT BEFORE I GAVE HIM SHOT  AFTER VACCINATION HE NEEDS TO SIT DOWN FOR 15 MIN  TO MAKE SURE HE IS OK.   HE FOLLOWED MY ADVICE AND HE WAS SITTING IN THE CHAIR APPORX 3 MIN AFTER   AND SUDDENLY HE FELL INTO GROUND FOR SHORT PERIOD OF TIME APPROX 30 SECONDS . HE WAS SWEATING AND VOMITING.  HE LOOKS VERY PALE .  HE WAS AWARE ABOUT SITUATION AND  I OFFERED HIM JUICES , CANDIES AND GRANOLA BAR. HE WAS ABLE TO DRANK JUICES (6 SMALL PACK OF JUICE)  AND STARTED TO HAVE CANDIES AND GRANOLA BAR.  AFTER HE ATE SOME FOOD HE FELT BETTER BUT WE WATCHE HIM ABOUT 1HR UNTILL HIS GRANDPA CAME HERE TO GIVE HIM RIDE HOM.   I CALLED HIM LEFT MESSAGE TODAY TO CHECK AND NOT RETURN MY PHONE CALL YET.
I have some disturbing stuffs, so right after vaccination I got bad, vaccine is not safe and effective; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "I have some disturbing stuffs, so right after vaccination I got bad, vaccine is not safe and effective".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
swelling, redness, warm to touch, pain. Started the morning of the 7/23/20, it caused patient to limp.
Pressure center of chest lasted a few seconds within the hour of the injection. Onset of red, pinpoint rash over anterior chest and shoulders. Red with some itching.  No SOB, no swelling
Information has been received from a licensed practical nurse (L.P.N.) referring to a female patient of unknown age. Medical history and concurrent conditions were not reported. On 05-APR-2015, the patient was vaccinated with a dose of RECOMBIVAX HB, lot # K012874, expiration date 09-JUN-2016 (dose not provided), intramsucularly, which underwent a supported temperature excursion. The patient sat for 15 minutes following vaccination. Co-suspect and concomitant therapies were not reported. No adverse effects were reported. This is one of two reports received from the same reporter. Additional information has been requested.
I have had various infections since the vaccine, sinus infection, upper respiratory infection, even a small cut became infected,  coughing, severe headache lasting about 8 days, dizziness, fatigue
Started with low grade fever progressed to temp from 101.7 to 103 degrees for 30 hours. Severe  headache, chills, weakness, joint pain and severe sinus pain upper nose. Sweats, headache and fatigue lingered for 48 hours. 24 hours after injection left arm became increasingly swollen, red, hot and it spread down my arm to my elbow. This has not yet resolved.  I was bedridden for 48 hours.
Moderna COVID-19 Vaccine EUA  Rash covering abdomen, sides, and chest. Does not itch or continue on arms or legs
Day after injection general body aches and injection site pain. 2nd day after injection severe bilat. knee pain and general joint aches and mild pain of general joints. 8 days after injection pain still persists.
5mins post vaccination pt had a syncopal event. Vitals: 11:25 97/58, 54, 20 100% -- > 11:35 95/54, 53 -- > 11:59 (sitting) 106/61, 62. Pt stable and released from the vaccination site @11:41
Patient experienced swelling in face hands and arms. Patient was treated with 50mg IM Benadryl and issue resolved in 20 minutes.