chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Sore at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore at injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination.     No medical history information was reported.  Concomitant products included GABAPENTIN for Inflammation, NAPROXEN for Pain inflammation activated.    On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced VACCINATION SITE PAIN (Sore at injection site). At the time of the report, VACCINATION SITE PAIN (Sore at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.
Right after taken vaccine waited for 25 minutes at facility. Not reaction. 10 minutes later i felt some numbness at my head but it was gone in less than a minute.  7 hours later at work. I started feeling tired. had a fever of 101 to 102. sore arm as well. Fever continue at night. next day woke up better not fever. Just tired. kept sweating during the day. Without any fever. blood pressure when up a little bit. nothing to worry about.  It has been 4 days since my shot. I just feel sore from my left arm. I will say it feels 9 out of 10 on soreness .
Started with burning sensation left shoulder, upper back and left posterior neck. Continue to have itchy whelp at neck and dull irritation at left upper back.
This spontaneous report as received from a nurse refers to unspecified number of patients of unknown age and gender. The patients' current conditions, medical history and concomitant medications were not reported. On an unknown date, the patients were vaccinated with improperly stored dose of ROTATEQ lot # M041184, expiration date 31-MAY-2018, (strength, dose and route of administration were not reported) for prophylaxis. The vaccine was exposed to 31 Fahrenheit degree (F) or colder (25F) for 1 hour 53 minutes and 47 Fahrenheit degree (F) to 77 Fahrenheit degree (F) (49F) for 3 hours 59 minutes (incorrect product storage). There was no previous temperature excursion. Digital data logger was involved. No adverse effects reported. There was no product quality complaint(PQC) involved. This is one of the two reports received from same reporter.; Sender's Comments:  US-009507513-1708USA003308:
She immediately felt chills and was dizzy. Patient had no problem breathing. Patient had no rash. Patient did not experience her throat closing. Patient did not faint.
Pt adm 1st dose of vax SC on 15NOV90 @ time of report there were no other adverse exp reported; No further details were provided;
Injection site reaction; Tenderness of the skin 2-3 inches from the injection site; Swelling of the skin 2-3 inches from the injection site; Redness in her skin; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE PAIN (Tenderness of the skin 2-3 inches from the injection site), VACCINATION SITE SWELLING (Swelling of the skin 2-3 inches from the injection site) and VACCINATION SITE ERYTHEMA (Redness in her skin) 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 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Tenderness of the skin 2-3 inches from the injection site), VACCINATION SITE SWELLING (Swelling of the skin 2-3 inches from the injection site) and VACCINATION SITE ERYTHEMA (Redness in her skin). On an unknown date, the patient experienced VACCINATION SITE REACTION (Injection site reaction). At the time of the report, VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE PAIN (Tenderness of the skin 2-3 inches from the injection site), VACCINATION SITE SWELLING (Swelling of the skin 2-3 inches from the injection site) and VACCINATION SITE ERYTHEMA (Redness in her skin) 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.   Concomitant medication include birth control pills. No treatment information provided.   This case was linked to MOD-2021-004542 (Patient Link).   Reporter did not allow further contact
Information has been received from a pharmacist referring to a patient of unknown age and gender. On 24-FEB-2016, the patient received an unspecified pneumococcal vaccine. On 16-MAR-2016, three weeks late the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # L003227, expiration date: 13-OCT_2016, route and dose were unknown). No adverse effects were reported. Additional information has been requested.
Headache, Myalgia, Fever, NauseaVomiting, INJECTION SITE PAIN Narrative:  Other Relevant History:
Day after vaccine received, tenderness and swelling of lymph nodes in the same area of injection. Each day, swelling and tenderness lessening.
My 28 year old daughter developed Idopathic Reynauld's Syndrome following her booster shot of Pfizer mRNA Covid Vaccine. She had no issues with her hands or feet prior to receiving the booster. Currently her physicians are running lab tests but the results won't be available for several days. Will send a follow up report once I have details. Labs are pending-will complete with follow up report.
Client reports pain in left shoulder, pain in left shoulder blade, and pain on left side of neck. She thinks the injections was given too high on her shoulder.
Fever; chills; muscle and joint pain throughout body; ,muscle and joint pain throughout body,; weakness.; stiffness; brain fog; nausea.; This is a spontaneous report from a contactable consumer, the patient. A 52-year-old female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8727), via an unspecified route of administration in the left arm on 26Mar2021 at 10:15 hours (at the age of 52-years-old) as a single dose for COVID-19 immunisation. The patients medical history included food allergy and COVID-19. Concomitant medications included pure encapsulations pure pack (supplement). The patient was allergic to nightshades (food). The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination the patient was not tested for COVID-19. On 26March2021, at 21:00 hours patient experienced fever, chills, muscle and joint pain throughout body, weakness, stiffness, brain fog and nausea. Therapeutic measures were not taken as a result of the event. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event fever, chills, muscle and joint pain throughout body, weakness, stiffness, brain fog, nausea was recovered on unknown date in March2021 at the time of this report.  No follow-up attempts are needed. No further information is expected.
Chills, pain in thighs to groin, weakness, tiredness, Left flank pain, temperature 101F, headache. Treatment Tylenol 1200 mg every 8 hours and Advil 600 mg every 6 hours, fluids and rest.
8 days after the first dose, my Mom developed a rash at the site of the injection. It lasted for about 6 days and it was the size of the palm of a hand.  She saw her primary care Doctor on 1/25/21 for a regular physical. He saw the rash (which had subsided) and advised her to take one Benadryl 30 minutes before she has the second dose of the Moderna vaccine on 2/10/21.  On 1/30/21 she had an episode where her face was tingling and she was not feeling well and a somewhat out of it. Today, 1/31/21, she is feeling better but still has tingling in her face.
4/5 - Trip to emergency room, fever 104 to 104.3, headache, backache, neckache (right side), chills, muscle aches, diarrhea, lethargic - first 3 days, then next 4 days  - intermittent fever - low grade, muscle aches, very lethargic, and diarrhea.    (7  or a few more in total) 4/20/21 -  2nd shot - 36 hours of low grade fever, 100 or less, headache, chills, muscle aches and diarrhea.
Information has been received from a nurse practitioner concerning a patient who in 2003 was vaccinated with VARIVAX (Merck) (lot# not reported). Subsequently the patient experienced an outbreak of chicken pox. The patient was then given another dose of VARIVAX (Merck) (lot# not reported) as a booster (date unspecified). It was unspecified if the patient sought medical attention. Additional information has been requested.
PATIENT STATES ARM IS HOT AND WARM TO TOUCH. REDNESS OBSERVED THROUGHOUT THE UPPER ARM AND HAS SPREAD.
I started having headaches, dizziness, stomachaches, diarrhea and generally feeling really bad. I was having tingling as well, muscle aches and leg cramps.
Patient vomited 9/23 am. Patient is currently pregnant and also experiencing morning sickness.
This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (slight headache) and MYALGIA (body soreness) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced HEADACHE (slight headache) and MYALGIA (body soreness). At the time of the report, HEADACHE (slight headache) and MYALGIA (body soreness) outcome was unknown.            No concomitant medications were provided. No treatment drugs were reported.
After the child received her very last vaccine dose she became pale and unable to follow commands. I assisted her to the ground and elevated her feet and initiated vital signs assessment. Time of vaccination 11:20am and B/P 117/66 Pulse 68. Patient was able to sit up at 11:27 am alert and oriented. She was able to walk out of the clinic with mom without any other assistance.
Information has been received from a registered nurse concerning a 37 year old male who in approximately 2000 was vaccinated with RECOMBIVAX HB (manufacturer unknown).  On an unspecified date the patient had a negative titer after the series completion.  In approximately 2001, the patient was administered 2 more doses of RECOMBIVAX HB (manufacturer unknown).  On 07-JUN-2007 lab diagnostics studies confirmed that the patient negative anti-hbs test less than 3.0.  No problems reported.  There was no product quality complaint.  Additional information has been requested.
Overwhelming weakness.  Inability to stand without aid.  unable to sit up.  only comfortable while laying down.   Weak appetite.  Have not sought any treatment.
little heart arrhythmia; Never had a reaction, other than tenderness at injection site nothing real significant; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. An 80-year-old male patient received BNT162b2 (BNT162B2), on 26Jan2021 as dose 1, single (Batch/Lot number: unknown) at the age of 78 years for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: ARRHYTHMIA (medically significant), outcome "unknown", described as "little heart arrhythmia"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Never had a reaction, other than tenderness at injection site nothing real significant". The event "little heart arrhythmia" required physician office visit. Age adverse event(s) started: Was just 3 weeks ago and is 80. Hadn't taken any prescription medication in probably 10 years. Noticed a little heart arrhythmia and the doctor checked him out and was on a 30 day heart monitor. Then they put him on this medication. Vaccine Supplemental Form: Covid-19 vaccine: First Dose: 26Jan2021, LOT: FL9265 or maybe EL9265. NDC, EXP: Unknown. Did any AE(s) require a visit to: Emergency Room: No; Physician Office: No. Prior Vaccinations (within 4 weeks): No. AE(s) following prior vaccinations: None. Never had a reaction, other than tenderness at injection site nothing real significant. Patient's Medical History (including any illness at time of vaccination) was None. Family Medical History Relevant to AE(s): No, don't think so. Relevant Tests were none. Is a sample of the product available to be returned, if requested (Y/N): not provided. Packaging sealed and intact was not provided. The patient underwent the following laboratory tests and procedures: Cardiac monitoring: was on a 30 day heart monitor. Therapeutic measures were taken as a result of arrhythmia.  The information on the batch/lot number for [BNT162B2], has been requested and will be submitted if and when received.
Pt recvd vax & approx 2 wks later exp herpes zoster;
Almost had to be admitted into Emergency room, but I left the hospital because they wouldn't let my husband inside.  I had severe heart issue! Not sure exactly what was wrong but I came close to having heart attack! This lasted for a few days. I had the worst dizziness that lasted more than 23 minutes! Chest pain, restricted  breathing, and static sound in my head between the ears. The vaccine  also left a taste in my throat even though I got the shot in my arm. My heart has not felt right since the vaccine! I felt wonderful just prior to getting the injection!
Right deltoid pain following TDaP immunization on 7/2/06. No swelling, no redness, no lymph adenopathy. Rash trunk.
Severe rash covering scalp, face, neck, chest all the way down the body that got worse every day, despite being on Zyrtec daily, and then taking benedryl every 4-6 hours. Rash continues to spread over even more of the body. Is red, slightly raised. My entire body burned and itched, even on benedryl, creams to stop itching. Body temp of 99.6. Started getting blood clots when blowing nose starting Thursday morning. Rash was even inside my ears. Was worst 72 hours after 2nd dose, and has gotten a little bit better each day. Still have mild rash and itching even 1 week after shot.
Intense pain in left foot. Started around the same time I got a fever, but lasted longer. Had difficulty putting weight on the foot and walking. Three days later and it is still not totally gone.
This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 25-MAY-2017, the patient was vaccinated with a dose of improperly stored RECOMBIVAX HB, 10/1.0 mcrg/ml injection, lot # M043422 with expiration date on 07-JUL-2019 (dose, route and site of administration were not provided). No adverse effects were reported. The vaccine experienced temperature excursion of 47-77 degrees Fahrenheit for 23 hours. There were no previous temperature excursions reported. Digital data logger was used to record the excursion. There was no product quality complaint involved in this case. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1706USA002756.
p/vax pt devel an inj site rxn characterized by tenderness, warmth, swelling & erythema in distal upper arm;pt later devel olecranon bursitis & erythema of the forearm & dorsal hand;
multiple temperature excursions for PEDVAXHIB; No additional AE reported; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Their pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies were not reported.  On 05-APR-2022, the patient received a dose of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) 0.5 milliliter (ml), administered as prophylaxis (dose regimen and route of administration was not reported). Lot# U014483 has been verified to be valid Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB), expiration date was provided and verified to be on 15-SEP-2023.  The nurse reported that there were multiple temperature excursions for Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB), and the vaccine had been administered to the patient (product storage error). A temperature excursion evaluation had not been performed at the time of the call.
Extreme pain along the spine from neck down to the lower back.  Could not stand for more than 5 mins.  Took 12 pain killers.   Skin rashes a  asthma since
Immunizations administered at 11:25 approximately 10 minutes later, child had redness at injection sites, extremities x 4 and trunk of body. No difficulty breathing. BENADRYL & MOTRIN administered per MD. Patient recovered & discharged home.
Passed out; Felt like two sticks in her stomach; Feeling of a warm flush; Fell on head; Sore arm; A spontaneous report was received from a consumer concerning a 68-years-old, female patient who experienced feeling of a warm flush, sore arm, felt like two sticks in her stomach, passed out and fell on head.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 15 Jan 2021, approximately prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 [Lot number 01ZC207] intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 15 Jan 2021, the patient felt like two sticks were in her stomach and then a feeling of a warm flush going through her body. She also had a sore arm. Patient felt like she was going to pass out and did pass out and fell on her head. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The events feeling of a warm flush, sore arm, felt like two sticks in her stomach, passed out and fell on head were considered not recovered/not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded.
Beginning in February, I had a sudden onset of extreme stiffness, decreased flexibility, decreased range of motion and pain in my shoulders, hips, knees. It is worst upon rising  after sleeping and after sitting down for longer periods of time. Over the counter anti-inflammatories not controlling symptoms. Symptoms still continue 7 months after vaccine
My blood sugar was 300, it has never been like this before; It went from 300 to 207; 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), administration date 21Mar2021 (Lot number: EN6207) as dose 1, single for covid-19 immunization.   The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: BLOOD GLUCOSE INCREASED (non-serious) with onset 23Mar2021, outcome "unknown", described as "My blood sugar was 300, it has never been like this before; It went from 300 to 207". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: After the vaccination on 23Mar2021 patient's blood glucose got up and it had never been like this before.   No follow-up attempts are possible. No further information is expected.
2.5X2 INCH REDESS, WARM TO TOUCH.  1X1 INCH THICKNESS OR KNOT WHERE VARICELLA SHOT WAS GIVEN
Flu vaccine 11/28/2006. On 12/03/2006 experienced onset of Left thigh pain, limp, fever, increased WBC and CRP but ESR 24, f/u labs 12/4 revealed myositis, left rectus femoris, increase ESR to 82, required IV antibiotics, Cefazolin, and inpatient admission. 01/01/07-records received and reviewed. DC DX for DOS 12/5-12/7/06 DX: left rectus femorus myositis.
ERYTHEMA, SWELLING  PAIN AROUND INJECTIONS SITE AND UPPER ARM. ALSO PT. REPORTED FEVER/CHILLS FOR 48HRS POST VACCINATION. TREATED WITH IBUPROFEN AND ICE.
s/s-pt arm sore immed;began to swell 1/2" x 3 inch diameter;got red & indurated;a red ring formed expanded to outer border center area-returned to nl skin color;swelling lasted 2 wk;
Information has been received from a physician and the mother of a patient concerning a 17 year old female patient who provided a link to a forum. In August 2008, the patient was vaccinated with the first dose of GARDASIL (Lot# not reported). The patient was diagnosed with Hodgkin's lymphoma 6 weeks after her second dose of GARDASIL (Lot# not reported). She discovered a lump on her neck 4 weeks after her injection and was treated for a swollen gland infection at first. The lump got larger after 2 more weeks. In October 2008, the patient had a computerized axial tomography (CAT scan) and her pediatrician sent her to the hospital that same night. The patient underwent chemotherapy and radiation and by the time of the report she was in remission. In October 2009, the patient had another computerized axial tomography (CAT scan) (result not provided) and would be monitored for the next 5 years. Upon internal review, Hodgkin's lymphoma was considered to be an other important medical event. Additional information is not expected.
Fatigue, injection site intense pain, body ache/pain all over, chills and shivering that evening, temperature of 100.8, headache all day.
Having an extended period while on mirena and birth control pills. Have not had one in a year.
Throat swelling, hoarseness, itching and headache, lasted about one hour, patient took Benadryl, symptoms improved.
thrush; weak; tested positive for Covid; tested positive for Covid; This is a spontaneous report from a contactable nurse (patient). A 61-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685, expiry date: unknown), via an unspecified route of administration on 21Dec2020 at a single dose for covid-19 immunisation. Medical history included ongoing COPD (chronic obstructive pulmonary disease) (not really diagnosed with COPD), ongoing smoker (smokes about 10 cigarettes a day; has smoked 40+ years), cough. The patient's concomitant medications were not reported. It was reported that on 31Dec2020, the patient tested positive for COVID from which she went to the doctor and was treated on 14Jan2021. The patient was given SOLU-MEDROL injection just to help her because she has mild COPD to bring up all of the junk. She is clear now. She doesn't have pneumonia. Her labs were good. She feels 80% back. The patient also experienced weak and thrush on unspecified date. Therapeutic measures were taken as a result of the event tested positive for COVID which included antibiotic and a cortisone injection, and for the event thrush which included NYSTATIN mouth rinse. Outcome of the event tested positive for COVID was recovering. Outcome of the remaining events was unknown.; Sender's Comments: Based on the mechanism of action of BNT162B2 vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine was given (10 days in this case). However, a causal relationship between event "tested positive with Covid " (coded to Drug ineffective / COVID-19) and BNT162B2 vaccine cannot be completely excluded.