chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous case reported by a consumer, describes the occurrence of gout (within 36 hours) and gait inability (she couldn't walk/she cant do anything) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. Concurrent medical conditions included diabetes. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced gout (within 36 hours) and gait inability (she couldn't walk/she cant do anything). At the time of the report, gout (within 36 hours) and gait inability (she couldn't walk/she cant do anything) outcome: unknown. No concomitant medications reported. Treatment information provided: a pill.
Was injected on 08/15/2006.  Began to have shortness of breath by 8/21/2006.  Was seen on 08/22/2006.  Was found to have an asthma exacerbation that required at least a week of oral steroids to calm down.
On 03/16/01, within 5-10 minutes of receiving the MMR, the child developed hives and a raised maculopapular rash on his face, legs, and spread all over his body. It was reported that the patient was immediately treated with epinephrine shot and was "reported as fine 20 minutes after the epinephrine". The child was given oral diphenhydramine for the weekend. On the date of the report, 03/19/01, the child was "seen in the clinic this morning and rash, itching, all gone". The report indicated that the first dose of MMR vaccine live was given at an unknown place and that it is unknown if the child had a reaction. Upon internal review, the patient's experience was determined to be other medical event. Additional information is not expected.
C/O localized inflammation "size of a golf ball" on LD where PNEUMOVAX was given on 2/7/13 around 1 pm 2/8/13 Pt went to PCP, was advised to take BENADRYL for the next 2 weeks. "Lt arm is inflammed from elbow all the way to the neck".
On 7/2/2021 patient went to ER with excrutiating pain in left arm. Arm was practically immobile. The ER ruled out a heart attack. X-rays were done to rule out broken bones. Patient was sent home with an anti inflammatory and Lidocaine patch.  Patient followed up with primary care physician and was given a muscle relaxer for symptoms.  Dr suggested exercises to help with immobilization.
Swelling in injection armpit (Right); Pain in lymphatic chair area.; Pregnant at the time of vaccination with Gestation period of 23rd week; Booster dose; This is a spontaneous report from a contactable healthcare professional, the patient. A 35 year old, pregnant female patient received the third booster dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection with Lot Number: FF2589) via an unspecified route of administration in the right arm on 12Oct2021 at 14:30 (at the age of 35-years-old) as a single dose for COVID-19 immunisation. Medical history included pregnancy and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The last menstrual date of the patient was on 04May2021. The patient gestation period was 23 weeks. Concomitant medication(s) included influenza vaccine (INFLUENZA VACCINE) taken for immunisation on 08Oct2021. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection Lot Number: EJ1686) via an unspecified route of administration on 10Jan2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation and the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, , Solution for injection with Lot Number: EL9264) via an unspecified route of administration on 31Jan2021 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 14Oct2021, the patient experienced swelling in injection armpit on right and pain in lymphatic chair area. The expected due date of the patient was reported as 08Feb2022. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the events (swelling in injection armpit on right and pain in lymphatic chair area). The clinical outcome of the events swelling in injection armpit on right and pain in lymphatic chair area was not resolved at the time of this report.
I Called Pt. Wed night to check up on anything and wife told me he was in bed. He noticed earlier that evening hive-like red bumps on arms, torso and legs. He told wife he thought he had chicken pox.
Constant headache x10 days after vaccination (HA starting day 1 post-vaccination).   Visual changes with aura type arc in middle of visual field lasting 30 minutes prior to resolving spontaneously- this occurred twice after vaccination date with 1st episode occurring at 1 week post-vaccination and 2nd episode occurring at 2 weeks post-vaccination.   Facial shingles at V2 dermatome (near Left eye) diagnosed 6/21/21; pending repeat eye exam 7/12/21 to follow this.
Patient has a rash at injection site probably 2-3" by 2-3", no temperature, doesn't hurt, just slightly red. Getting better today. Overall patient says it doesn't bother her.
no adverse event; Customer called and reported that a consumer was about to receive a dose of ROTATEQ but then the parent refused; This spontaneous report was received from an office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  The customer called and reported that on 09-SEP-2022a consumer was about to receive a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ), but then the parent refused (missed dose). Limited information was provided from customer. No additional adverse event (AE) was  reported.
a rash has developed /  have a hot, red rash; have a hot; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 15th June 2021, the patient received the 2nd dose of Shingrix. On 16th June 2021, 1 days after receiving Shingrix, the patient experienced red rash and feeling hot. On an unknown date, the outcome of the red rash and feeling hot were unknown.   It was unknown if the reporter considered the red rash and feeling hot to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient for herself/himself. The age at vaccination was not reported. The patient received 2nd dose of shingrix and experienced a hot and red rash. The patient asked if he/she should notify to doctor or not.
PFIZER VACCINE WAS NOT DILUTED AT ALL SO GAVE 0.3ML OF UNDILUTED VACCINE.  WAS APPROXIMATELY 0.1ML REMAINING IN VIAL
Received a spontaneous report on 23JAN2018, 24JAN2018 and 25JAN2018 from a Regulatory Authority. The physician reported that on 23JAN2018, a patient who was overseas, received 5 ml of BIOTHRAX vaccine injected into the deltoid rather than the prescribed 0.5 ml amount. The subject experienced soreness at the site, and then developed mild headaches approximately 8 hours after the injection. No other complications were reported after 24 hours observation. The subject was restricted from caffeine and working out for the first 72 hours. It was also noted that he received a flu shot on 19DEC2017 and was on doxycycline for malaria prophylaxis. FOLLOW UP Information was received on 16FEB2018 from the physician. The physician reported that the patient was evaluated by medics and no evidence of lingering side effects was found. It was also noted that the patient felt excellent, had no signs of complications at the sight, and no signs or symptoms that would lead one to believe he is not in perfect/usual health. No additional information is expected.
SWOLLEN LYMPH NODE IN LEFT SHOULDER NEAR NECK STARTED THE DAY AFTER VACCINATION AND HAS PERSISTED YET IMPROVED SINCE 5-7
pt recv vax & became sl cyanotic & lifeless;pt taken to ER;pt given CPR & IV fluids;pt & parent sleeping in sofa bed;
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 21-OCT-2015, the patient was vaccinated with 3rd dose of improperly stored GARDASIL with lot number: K016966, expiry date: 10-MAY-2017 (dose and strength unspecified). No concomitant medications were reported. No adverse effects were reported. There were no product quality complaints (PQC) involved. No additional information was provided. This is one of the several reports from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to a male patient of unknown age with a present case of shingles. No information regarding the patient's medical history was provided. On 08-JUL-2015, the patient who at this time already had shingles, was vaccinated with a dose of ZOSTAVAX (strength, dose, route of administration, lot# and expiry date were not reported). There were no concomitant therapies reported. The pharmacist was not aware that the patient had a present care of shingles when she administered the vaccine. It wasn't until after she administered ZOSTAVAX that the patient mentioned he currently had shingles. The patient said the shingles developed prior to receiving ZOSTAVAX and he had "two shingles spots" on his body at the time of vaccination. He was supposed to take VALTREX to treat his shingles but he did not start the treatment. It was unspecified why did the patient request ZOSTAVAX. No adverse symptoms were reported with ZOSTAVAX administration. Additional information has been requested.
This child presented to school nurses office 02/27/01 at 8:30 AM with a few scattered papules on both forearms and more diffuse maculo-papular rash upper and lower legs bilaterally. Afebrile. The family physician advised Benadryl for 6 days. Rash resolved on the 7th day.
Pt began to develop numbness and limited range of motion in left arm within 24 hours of receiving vaccine and this has continued. She is now not able to move this hand. She told me she saw a hand doctor and they told her it was consistent with Parsonage Turner Syndrome.
Patient called me reporting that on 9/10/07 he developed "boils"-fluid filled on his abdomen, elbow, buttocks (6 total), a fever, and achey joints. (L) knee became swollen on 9/12/07. He plans to be seen in the ER today.
Medication Error. At 8:35am attendee received 1st dose of Pfizer to left arm and as it was being injected intramuscularly the syringe disconnected from the needle, less than half of the vaccine was administered.  EOA stated he was observed for about 30 minutes and then left with father.
Pt recvd vax & lab eval revealed was neg for rubeola antibody; repeat testing in DEC92 showed the same results; No further details were provided;
Slight headache day after shot, swollen and sore arm at injection site for almost an entire week. Headache didn?t get better but continues to get worse until treatment had to be sought  Continued pain in left calf
Pt had previously received Johnson and Johnson vaccine.  Pt returned when site was giving second doses of Moderna and pt received dose of un-needed Moderna.  no treatment and no adverse effects noted
Lymph node swelling 2 days after first vaccine in neck same side as vaccine was given.; This is a spontaneous report from a non-contactable nurse, the patient. A 46-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on 06Aug2021 at 15:30 (at the age of 46-years-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism on an unknown date and unknown if ongoing. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN) and fluoxetine hydrochloride (PROZAC) for unknown indications, from unknown start dates and unknown if on going. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 08Aug2021, 2 days after the first vaccine, the patient experienced lymph node swelling in neck on the same side as vaccine was given. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event lymph node swelling in neck on the same side as vaccine was given was resolving at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Left upper arm swollen, itchy tender about 3 inches in all directions surrounding injection site 1 week ago. Other arm is fine. In left arm, he received flu vaccine and KINRIX.
I was extremely tired. I had a low-grade fever. Strangely my thighs and my hips ached; lasting 2-3 days. I had some nasal congestion WITHOUT a cough. I sort of had a come and go headache. The feeling of exhaustion lasted about 2-3 weeks. I noticed since testing positive; I can't tolerate exercise as well as I did before. I excessively sweat now and get tired a lot easier. Surprising my asthma did not trigger while being positive.
This spontaneous report as received from a Nurse Practitioner refers to a patient of unknown age (gender unspecified). The patient was vaccinated with the first dose of 0.5 ml GARDASIL intramuscularly on an unspecified date 6 years ago in approximately 2007. The patient was in the office on 24-JAN-2013 to received the second dose of GARDASIL. No adverse effects reported. No lot # was provided. Additional information is not expected.
Recvd 1st dose of vax Dec90 or Jan91, 12 to 18 hrs /p vax dev generalized seizure(tonic-clonic activity /w incontinence observed) was postictal /p event, Seen by MD stated there are no long term sequelae,not vax related.  EEG's abnorm
Initial information received on 19-Jun-2018 regarding an unsolicited valid non-serious case received from a nurse. This case involves a patient (age and gender was not reported), who was vaccinated with only Dtap/IPV portion of PENTACEL (Batch number, expiration date, dose, dose in series, route and site of administration were not reported) on an unspecified date. Patient's medical history, family history and concomitant medication was not reported. It was a case of actual medication error due to inappropriate reconstitution technique. 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. Documents held by sender: none.
Medical history included ongoing hypersensitivity , ongoing asthma. The patient concomitant medications included products for allergy. The patient experienced debilitating back, spinal and muscular pain in his back on an unspecified date with outcome of recovering , not really able to move at all on an unspecified date with outcome of unknown , he has cramps on an unspecified date with outcome of unknown.  The clinical course was as follows 24 hours after the vaccine, he developed debilitating back, spinal and muscular pain in his back for at least 72 hours. He was not really able to move at all.  It got better to the point he can function now, but he is still getting it.  He has cramps, back aches, spinal aches, muscles aches from it still. They have Improved but not resolved. He didn't receive treatment for them. The only thing he did take is Advil it kind of helped. He knows it is contraindicated for 6 weeks after the vaccine , so he tried not to take it. He only took it for the debilitating pain. The events were assessed as non-serious.   No follow-up attempts are needed. No further information is expected.
When pt returned to office 1/29 localized swelling and redness at site. PA prescribed antibiotic 11:00 1/29 pt returned to clinic 1/31 at 1:30 pm swelling was spreading down arm we recommended she go to ER.
Left arm became red, warm, swollen within hours of injection. This continued to spread starting with a 2 inch circle and spreading down the arm to the elbow and encircling the arm.  Warmth, pain, swelling and redness increased. Also had profound weakness and lethargy that lasted three days.  No elevated temperature.    Contacted Dr. on 2/5/21 via email in MYCHART Main line health.  He advised cool compresses, hydrocortizone and Benadryl or Claritin.  We continued this regimen with no improvement  until 2/16/2021. At that time redness was faint on arm about 2 inches of deep red and painful circling arm near elbow.  On 2/18/2021 rash gone but skin peeling from shoulder to midarm.  No further pain or redness or warmth after 2/20/2021
Fever 102.2, extreme pain at injection site, wheezing, difficulty breathing, joint pain, severe headache.  Took 600 mg Ibuprophen and 1,000 mg of Tylenol which helped to break temperature and subside other symptoms.  Next morning felt confused/could not concentrate/pay attention, felt lethargic.  Husband took her to ER.  At ER, wait too long, couldn't sit up so went back home.  Took more Tylenol and Advil to fight fever ever since.  She thought she was going to die.  Called doctor upon return from ER but did not know what to do.  Recommended just to fight it, wait until it went away.  The fever won't break.  Hoarseness has worsened as well as joint pain.  Feels dizzy from fever.  Can think more clearly now but can only break fever for about 30 minutes; it goes back to 102.
Patient became nauseated, dizzy, could not comprehend what people were saying, eyes started to become watery and very dilated. Patient took one Benadryl pill and in two hours felt a lot better but eyes were still dilated.
nerve pain; lasting side effect of muscle or nerve pain; ongoing pain in his thigh; This case was reported by a consumer via interactive digital media and described the occurrence of nerve pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2021, the patient received Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced nerve pain, muscle pain and pain in thigh. On an unknown date, the outcome of the nerve pain and muscle pain were unknown and the outcome of the pain in thigh was not recovered/not resolved.   It was unknown if the reporter considered the nerve pain, muscle pain and pain in thigh to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The events were reported by the patient's wife. The reporter stated that, the patient received vaccine in early January this year and had ongoing pain in his thigh since then. The patient also probably had muscle and nerve pain. The reporter inquired if it was possible for the Shingrix vaccine to have a lasting side effects of muscle or nerve pain.
I take B12 shots in the left arm as well. On Jan 7th pain soreness, chills, slight fever, and body ache. The vaccine reaction symptoms were gone before noon next morning. However, the shoulder pain did not go away for 5 days. I did an internet search and found information regarding too many shots in my arm. I did reach out to Dr. in mychart portal. I can do an MRI without approval without doing 6 weeks of PT. She is looking into coding it so that the insurance can code it. I am hoping it doesn't flare up again. I just take OTC Ibuprofen 600mg, I had 5 days of pain and I am still not doing what I was before. My shoulder joint is starting to be normal. The actual injection site is sore. Both times I had this pain it came on very sudden. I couldn't move the arm and the suddenness about it really bothered me and there was nothing gradual about it. I am frustrated that I cannot get an MRI when I know that is the only to determine what is going on. It is not a shoulder injury and I do not want to go through 6 weeks of PT. Shoulder surgery 2010. MY doctor is trying to get the MRI approved but I do not feel hopeful this is going to happen. I feel that two dental procedures may have caused this. 01/05/2022 a cleaning and then the following week on January 14th I had a dental procedure and the pain in my arm returned suddenly. The fever and chills were much worse. Those symptoms were gone by the next afternoon.
1-22-21 @ 10:20am 2-19-21 @ 10:20am Moderna LOT # 029L20A Moderna LOt # 023M20 redness about 3inches in diameter at the injection site traveling downward started 2-20-21 recommended antihistamines, to ice (10mins on/10 mins off), and to draw a line around the area to compare improvement or worsening of the affected area; verbalized understanding.
On 09/06/2003, mother states child had fever (100 degrees), red, swollen area at left deltoid with complaints of itching.  Called ER on 06/07/2003-advised to go to clinic.  Saw PA received Benadryl per mouth.  Symptoms subsided by 09/09/2003.  Developed Stas Disease on 09/08/2003.
Client received HBV #1 on 5/3/00. At time of clinic visit for HBV #2, she reported that she developed tightening of chest and throat for 10-20 minutes, post vax, HBV #1. Clinic doctor notified. HBV #2 and HBV #3 deferred. Client advised to check with allergist of PMD regarding further HBV's.
Discomfort in lower back; loss of appetite; orange urine; constipation; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL DISCOMFORT (Discomfort in lower back), DECREASED APPETITE (loss of appetite), CHROMATURIA (orange urine) and CONSTIPATION (constipation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 17-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL DISCOMFORT (Discomfort in lower back), DECREASED APPETITE (loss of appetite), CHROMATURIA (orange urine) and CONSTIPATION (constipation). At the time of the report, MUSCULOSKELETAL DISCOMFORT (Discomfort in lower back), DECREASED APPETITE (loss of appetite), CHROMATURIA (orange urine) and CONSTIPATION (constipation) outcome was unknown.            No relevant concomitant medications were reported.  No treatment information was provided.
right away - right arm sore, 30 min post injection -fatigue, 2hrs post injection - body aches, went to sleep - hot and cold spells through night, tossing and turning because uncomfortable.  Woke up 15hrs post injection with itchy redness noted on right side of neck, area of itchy redness continue to spread.  Consulted to Urgent Care by Employee Health Nurse at 11:00 am
Blood clot in right knee. DVT,  gastrocnemius. Embolism and thrombosis of superficial veins of right lower extremity
Severe redness at site 9 cm x 12 cm raised in some areas. Itchy.
Just had diverse joint pain: knuckles, SI joints and neck. I think I know what caused my neck pain, the rest was unexplained. This began in mid-January and now getting better, but not completely resolved.