chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Nausea; aching bones; horrible fatigue; This is a spontaneous report from a contactable consumer (patient reported herself). A 69-year-old non-pregnant female patient received second dose of BNT162B2 (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration to her left arm on 02Feb2021 10:45 AM (Lot number: EL9262) as single dose for Covid-19 immunization. The patient's medical history included heart failure, 3 strokes and diverticulitis. The patient had known allergies with CIPRIANI, doxycycline (DOXY), methotrexate, nitrofurantoin and morphine. Concomitant medications included clopidogrel bisulfate (PLAVIX), ranolazine (RANEXA), levothyroxine, atorvastatin calcium (ATORVASTIN) and duloxetine hydrochloride (CYMBALTA) (other medications in two weeks). The patient previously took first dose of BNT162B2 (COVID 19, Pfizer) via an unspecified route of administration to her left arm on 12Jan2021 10:45 AM (Lot number: G1284) as single dose for Covid-19 immunization. On 02Feb2021 09:15 PM, the patient experienced nausea along with aching bones and horrible fatigue. Covid was not tested prior or post vaccination. The patient took an opioid for nausea that made worse. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Eyes started burning a lot; sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Mar2021 (Lot number: EN6208) at the age of 61 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Has allergies" (unspecified if ongoing); "anaphylactic shock a lot" (unspecified if ongoing), notes: 40 years ago used to go into anaphylactic shock a lot, was treated. The patient's concomitant medications were not reported. The following information was reported: EYE IRRITATION (non-serious) with onset 2021, outcome "unknown", described as "Eyes started burning a lot"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "sore arm".  Additional information: At least half an hour after the dose. Eyes started burning a lot. Wanted to pull over and close them.  Kept trying and opening one eye at time. Kept burning. Took an antihistamine prior to vaccination just in case. Laid down and feel asleep for about an hour. When he woke up it was gone. Had the usual sore arm. Had other vaccines: Shingles on 03Sp2021. Second dose schedule for 03Nov2021. Flu on unknown date. One time had flu vaccine on a Sunday. Felt pretty lousy heading into work. The patient also received 2nd dose of BNT162B2 on 06Apr2021 and Booster on 06oct2021.  No follow-up attempts are possible. No further information is expected.
Mother reports pt. felt warm last night (same evening as vaccine administration). Temperature of 99.8 at 8:00am today and 101.5 degrees F at 10:00am today. Pt. lethargic with no appetite but did sleep well last night. Right lower leg began redness, warmth and swelling sometime between 8:00-10:00am.
Narrative: Pt is a 92y.o. male who died on 04/25/2021 w/ h/o dementia, PE, HTN, Hypothyroidism, CAD, SCC, BPH, HTN. Pt received Moderna Covid-19 Vaccination 2/2 on 02/12/2021. Pt transferred to LTC on 03/15/2021. Pt died on 04/25/2021. Unlikely that Moderna Covid-19 Vaccine caused/contributed to pt death
AFTER ~1 HOUR AFTER CHILD WAS IMMUNIZED, MOM CALLED STATING THAT CHILD WAS C/O A SEVERE HA, NAUSEA, AND NUMBNESS AND TINGLING IN HER LOWER EXTREMITIES. I ADVISED HER TO SEEK IMMEDIATE MEDICAL ATTENTION.
No additional AE reported; spit up; This spontaneous report was received from a physician referring to a 2 months old patient of unknown gender.  The patient's concomitant medication, pertinent medical history and drug allergies or reactions were unknown.      On 18-OCT-2021, the patient was vaccinated with first dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (strength, lot# and expiration date were unknown, 2 ml) orally as routine vaccination. During vaccination, the patient split up the dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (under dose). It was unsure if the patient received any amount of the vaccine. No additional information and adverse event were provided (no adverse event).
Seven minutes after administration, heart began suddenly racing with mild shortness of breath. Heart racing snd shortness of breath resolved after 30- 45 seconds.  After symptoms resolved, heart rate was 98 and BP 112/70.
felt like my hamstring was pulled but it wasn't my hamstring, in my foot like my veins in my foot and they still hurt; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number unknown), via an unspecified route of administration on an unspecified date as first dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient stated that he/she was at a vaccination center because he/she was due to get the 2nd shot but was also a little bit worried about getting a 2nd shot because (and told the doctor already too) after getting the 1st shot, he/she felt like a reaction. On an unspecified date, the patient reported that he/she felt like his/her hamstring was pulled but it wasn't the hamstring, in the foot like the veins in foot and they still hurt, and they were just uncomfortable and it felt like a little pinging sensation. The patient reported that he/she can walk and everything but knew that there was something that's not right and has never felt any kind of issues with the heels of his/her foot or any veins on the feet so the patient thought it was really odd and just wanted to talk to someone before getting the 2nd dose. The outcome of event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
On 06/08/2021 Dr and you bp was 200/100 almost. fatigue. Dr increased my bp meds by three times and a water pill, and it did not bring it down much.  It is still going on as of today 07/09/2021. Also found out I have low T levels. I just did a sleep study and results unknown.
I developed a small rash at the injection site and lasted a couple days. I had a slight fever, cough and runny nose on 02/23/2023 and I tested positive for COVID-19. I contacted my doctor and got a prescription for PAXLOVID. I took two doses and stopped because I developed a rash. As of today, I still have a slight cough.
Itching on Right Arm, on the outside of her arm; Flu Vaccine 09Aug2021/ Pfizer Covid Vaccine First Dose 09Aug2021; she didn't present her period since the first shot.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 09Aug2021 (Lot number: FD8498) at the age of 42 years as dose 1, single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administration date 09Aug2021 (Batch/Lot number: unknown). Relevant medical history included: "Leep Procedure", start date: 2021, stop date: 2021; "Biopsy cervix", start date: 20Jul2021, stop date: 20Jul2021; "little bleeding from the biopsy" (unspecified if ongoing). Family history included: "she is fixed, she has had her tubes tied" (unspecified if ongoing). There were no concomitant medications. The following information was reported: AMENORRHOEA (non-serious) with onset Aug2021, outcome "not recovered", described as "she didn't present her period since the first shot."; PRURITUS (non-serious) with onset 09Aug2021, outcome "recovered" (09Aug2021), described as "Itching on Right Arm, on the outside of her arm"; PRODUCT USE ISSUE (non-serious) with onset 09Aug2021, outcome "unknown", described as "Flu Vaccine 09Aug2021/ Pfizer Covid Vaccine First Dose 09Aug2021". Therapeutic measures were not taken as a result of amenorrhoea, pruritus.  Additional information: Family medical history relevant to AE(s) were none. AE(s) following prior vaccinations were none. Prior vaccinations (within 4 weeks) were none. Ae(s) did not require a visit to emergency room or physician office. Time the vaccination was given was at afternoon to evening. The patient stated the biopsy was on 20Jul2021, and she doesn't know if she had a period in July, she was not positive of when she had her last period, it might have been the week prior to the biopsy. The patient stated she also had itching on her right arm on the outside of her arm. She had two different Band-Aids, so it could have been from the Band-Aids, but she hasn't had an allergy to them before. The patient stated it went away when she changed the Band-Aid.  No follow-up attempts are possible. No further information is expected.
Pt was given injection at 15:30 on Friday. On Saturday at 16:00, injection site was the size of a baseball, red, hot and itching. Was given 1 1/2 tsp Benadryl and inflammation was gone the next morning.
Two weeks and one day after receiving second dose of COVID19 vaccine, patient experienced extreme sharp pain in injection arm (left arm: injection site, shoulder and elbow) as well as muscle in  opposite leg and hip that prevented him from walking.  Pain has minimized since then (report is one week after incident) but patient still  feels some minor pain, and says he will report to his primary care provider if symptoms persist for one week. Patient took aspirin for pain, which helped.
Started itching the night on the day the vaccine was administered, but didn't notice lump until the next day.
had the runs (meaning stomach issues); felt dizzy; pressure to the back of his head, pressure around temple; pressure behind his eyes; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (had the runs (meaning stomach issues)), DIZZINESS (felt dizzy), HEAD DISCOMFORT (pressure to the back of his head, pressure around temple) and OCULAR DISCOMFORT (pressure behind his eyes) in a 20-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Sep-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 ABDOMINAL DISCOMFORT (had the runs (meaning stomach issues)), DIZZINESS (felt dizzy), HEAD DISCOMFORT (pressure to the back of his head, pressure around temple) and OCULAR DISCOMFORT (pressure behind his eyes). At the time of the report, ABDOMINAL DISCOMFORT (had the runs (meaning stomach issues)), DIZZINESS (felt dizzy), HEAD DISCOMFORT (pressure to the back of his head, pressure around temple) and OCULAR DISCOMFORT (pressure behind his eyes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication were provided.  No treatment medication were provided.
Moderna vaccine dose #1 received in right shoulder on 12/31/20 at 2:15PM. Injection was uneventful other than sensation of pressure. I did notice at the time, but could not fully see, that the injection appeared to be much higher on the shoulder than normal. I immediately came  home afterwards and relaxed. Approximately 2hrs later, I began experiencing extreme pain in my right shoulder. As the night progressed, the pain worsened to 10/10 with inability to move my arm. Later that night after requiring assistance to take off my shirt, I noticed that the bandaid overlying the injection site was very high, immediately below and bordering the acromion process. This was concerning but I was hopeful the pain would go away over the next few days. I took tylenol that night. I woke up multiple times during the night because the pain was so severe. When I woke up, the pain and inability to move my arm were still present. I began taking 800mg ibuprofen and 1000mg tylenol alternating Q4 throughout the next few days. The pain and disability remained so severe that I required assistance performing ADLs for  the next 4 days. On day four, with the pain not resolved and still severe despite consistent advil and tylenol use, I began having concern for shoulder injury related to vaccine administration. The next day I decided to seek an evaluation by an orthopedist. I am a physician and was unable to perform basic tasks and ADLs. I happened to have a few days off after the injection but would not have been able to work had I not. After an evaluation by the an orthopedic PA, I obtained an MRI of my right shoulder with results shown below - as I expected evidence of rotator cuff tendinopathy and subdeltoid bursitis consistent with SIRVA. As of now, I still have limited range of motion and shoulder pain on the right which has improved slightly but is far from resolved. I still have difficulty with certain ADLs including putting clothes on and off, lifting items, and tasks that require raising my right arm above my head. I am concerned with the possibility of long term and/or permanent damage after reviewing the literature. I am also concerned about how many other healthcare workers the person who gave me my vaccine may be injuring and/or causing permanent harm to.
Teacher presented with child stating she was having a reaction on R arm on interior part of arm between elbow and shoulder. Raised red area with weeps. No redness or swelling at injection site. No hives or rash on body.
Excursion/ Thawed 3 times/Unknown # of patients dosed with vaccine exposed to room temperature >24 hours; Unknown number patients administered invalid dose/Unknown # of patients dosed with vaccine exposed to room temperature >24 hours; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Excursion/ Thawed 3 times/Unknown # of patients dosed with vaccine exposed to room temperature >24 hours) and EXPIRED PRODUCT ADMINISTERED (Unknown number patients administered invalid dose/Unknown # of patients dosed with vaccine exposed to room temperature >24 hours) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Excursion/ Thawed 3 times/Unknown # of patients dosed with vaccine exposed to room temperature >24 hours) and EXPIRED PRODUCT ADMINISTERED (Unknown number patients administered invalid dose/Unknown # of patients dosed with vaccine exposed to room temperature >24 hours). At the time of the report, PRODUCT STORAGE ERROR (Excursion/ Thawed 3 times/Unknown # of patients dosed with vaccine exposed to room temperature >24 hours) and EXPIRED PRODUCT ADMINISTERED (Unknown number patients administered invalid dose/Unknown # of patients dosed with vaccine exposed to room temperature >24 hours) had resolved.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No treatment medications were provided.  Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Non-significant follow-up appended On 21-Sep-2021: Updated report's details and added Batch/Lot number. On 23-Sep-2021: The follow up document contains no new information. On 24-Sep-2021: Follow-up received contains additional non-significant information. On 25-Oct-2021: Non-significant follow-up due to reporter information updated.
Patient complains of nausea.  This is nausea, without vomiting.  This has been present for the past 2 weeks.  The frequency of episodes is several times daily.  Associated symptoms include lightheadedness and weakness.  Pt received her first Moderna COVID-19 vaccine on 3/11/21, she has been experiencing these symptoms since that date. ROS:  CONSTITUTIONAL:  Negative for chills, fatigue, fever, and weight change.   CARDIOVASCULAR:  Positive for tachycardia.   RESPIRATORY:  Positive for dyspnea and unusual chest pain.   GASTROINTESTINAL:  Positive for heartburn.   MUSCULOSKELETAL:  Positive for bilat leg pain.   NEUROLOGICAL:  Positive for weakness.   PSYCHIATRIC:  Positive for frustrated.
Fever, swelling of crotch, very painful in crotch area, big bump in crotch area, rashes in trunk area, rashes on leg, itchy, irritable, fatigue, bumps along inguinal area (marble like), lasted for 3 weeks.
Redness and swelling- increased with time a large change between night time the day of injection and the next morning, is about 1 inch in diameter at the injection site. Increased sensitivity of skin- Onset: 7:30 pm day of injection Chills- Onset: 3:30 pm the day after injection; fatigue- Onset: 5:30 AM the day after injection; headache- onset: 7:30 pm the night of injection; swelling of lymph nodes- Onset: 7:30 pm the night of injection. All symptoms have continued.
Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Mild, Systemic: Nausea-Medium, Systemic: Vomiting-Medium, Additional Details: EMS was called. However patient recovered prior to EMS arrival. Contacted patient at 8pm on 03/23/21. Patient stated he was doing fine and did not need to seek additional medical attention as of the time we spoke.
Patient's daughter called to inform the pharmacy that the patient was experiencing severing pain in the arm that she had received the flu shot in a day prior. She stated that there was slight redness at the sight of the injection and the patient was running a slight fever. She also mentioned that the patient was unable to move her arm in which she had received the flu shot - patient was advised to take otc pain medication and ice the area- patient was told that if it does not get better - she was to contact her primary care physician
19 hours after vaccination: Chills Dizzy Heart Racing Tightness in chest Shortness of Breath
BODY ACHES IN MUSCLES, ARMS AND LEGS; FEVER; HEADACHE; This spontaneous report received from a patient concerned a 48 year old female. The patient's height, and weight were not reported. The patient's past medical history included skin disease, and back problems, and concurrent conditions included fibromyalgia, epstein barr virus, anxiety, immune deficiency disease: hailey hailey, chronic fatigue syndrome, penicillin allergy, allergy to dogs, allergy to cats, and allergy to dust. The patient did not have any drug abuse/illicit drug use. The patient was not pregnant at the time of reporting. The patient was non-smoker and non-alcohol user. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 08-MAR-2021 11:00 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 08-MAR-2021, the subject experienced headache. On MAR-2021, treatment medications included: paracetamol. On 09-MAR-2021, the subject experienced body aches in muscles, arms and legs. On 09-MAR-2021, the subject experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from body aches in muscles, arms and legs, and had not recovered from headache, and fever. This report was non-serious.  Version created to correct previously reported information: Treatment drug corrected.
Low-grade fever, chills, shivering, joint pain, skin sensitivity beginning 12 hours after vaccination and lasting the following 18 hours.
vomiting; nausea; This is a spontaneous report from a contactable consumer, the patient. A 66-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration 19Jan2021 at 14:30 date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 19Jan2021 at 18:15, the patient experienced vomiting and nausea and she started to feel better on the same day at 20:15. The clinical outcome of the event vomiting and nausea was recovering.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
pt recvd vax;woke up middle of noc crying, would not take acetaminophen; clammy, did not want to respond to mom; to er, T 101.2;apap given; responded normally the rest of the day;
-Some chest discomfort and stiffness near the area of the chest above the heart -Soreness at the site of injection even after 1 week  -Tightness in the chest when breathing (not frequently, but maybe 2-3 days in a week)
on day # 6 after 1st dose developed enlarged lymph near clavicle, tender, large and warm to touch
The vaccine was initially moved from  the freezer to the refrigerator on 10-May-2022 and was administered on 13-Jun-2022; Moderna COVID-19 vaccine was administered after the 30 day beyond use date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The vaccine was initially moved from  the freezer to the refrigerator on 10-May-2022 and was administered on 13-Jun-2022) in a 65-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 004M21A) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jun-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 13-Jun-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was initially moved from  the freezer to the refrigerator on 10-May-2022 and was administered on 13-Jun-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna COVID-19 vaccine was administered after the 30 day beyond use date) and PRODUCT STORAGE ERROR (The vaccine was initially moved from  the freezer to the refrigerator on 10-May-2022 and was administered on 13-Jun-2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided.  The vaccine was initially moved from the freezer to the refrigerator on 10-May-2022, and the manufactured date was 13-Dec-2021.  It was reported that the vial had not undergone any temperature excursions.  It was also reported that the patient had not experienced any symptoms after receiving this dose of the vaccine. Reportedly, no additional doses, medications, or treatments had been administered in response to this error.
On 1/8/18 Patient reported to pharmacy. She states on morning after flu vaccine, she awoke with entire left side of body numb. She called her physician who sent her to ER to rule out stroke.   Symptoms began to resolve later that night. She reports mild symptoms still in left fingers as of 1/8/18, but her doctor tells her that will eventually go away.