chrisvoncsefalvay/vaers-outcomes huggingface dataset:
lower back pain/ back pain still present; herniated disks; chills; fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever), FATIGUE (fatigue), BACK PAIN (lower back pain/ back pain still present) and INTERVERTEBRAL DISC PROTRUSION (herniated disks) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 046A21A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 01-Apr-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue). On an unknown date, the patient experienced BACK PAIN (lower back pain/ back pain still present) and INTERVERTEBRAL DISC PROTRUSION (herniated disks). On 03-Apr-2021, CHILLS (chills), PYREXIA (fever) and FATIGUE (fatigue) had resolved. At the time of the report, BACK PAIN (lower back pain/ back pain still present) outcome was unknown and INTERVERTEBRAL DISC PROTRUSION (herniated disks) had not resolved. Not Provided          The patient has herniated disks but now they aren't responding to normal treatment, stretches, yoga and movement.   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Non Significant Follow up
Pt had vasovagal syncope shortly after shot was administered. Felt a little hot and nauseated. Also complained of being weak. Peds clinic next door. Pt laid down in room for about 15 minutes. Felt better and left.
Very sore arm, lots of swelling and redness at the injection site, nausea Starting after midnight:  chills, nausea Nausea and aches lasted through the next day Sore arm and swelling lasted a few days Also - I have developed a few sores on my chest that look like shingles ... very itchy but not painful. They remind me of what I had when I had shingles years ago.
The arm swollen and redness went from my injection site to past my elbow and around to the back. I contacted my Dr about 5-7 days after it began, it was so long ago how am I supposed to remember the dates. The Dr gave me a 7 day supply of Cortisone. After that it began to go down, although I did have pain in the arm and around the arm as well, which was constant and is still there for that matter actually. The Dr just said it was an allergic reaction to the shot.
Dose administered after improper storage and handling; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of PRODUCT STORAGE ERROR (Dose administered after improper storage and handling) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) 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 06-Jun-2021, the patient experienced PRODUCT STORAGE ERROR (Dose administered after improper storage and handling). On 07-Jun-2021, PRODUCT STORAGE ERROR (Dose administered after improper storage and handling) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drugs were reported. No treatment information was reported.  Vaccine was given to 9 patients on 6 JUNE 2021 & 7 JUNE 2021 which were mixed up in the refrigerator, health care professional comes to know that he vaccinated vial was in the refrigerator from 31 to 34 days, but the exact days were not clear to the health care professional.
silver dollar size whelp at point of injection raised about 1/16 of an inch with bright redness throughout whelp.  Physician ordered antibiotics (unknown) to cover risk of cellulitis.
Patient received 2nd dose of Pfizer on 4/11/21- after injection patient reported nausea and began frank vomiting. Patient received physician evaluation and ems provided Zofran 4mg.
This initial spontaneous case, was received from other health professional on 15-Oct-2017, concerning a 53-year-old adult female patient. On 02-Oct-2017, the patient was administered with FLUVIRIN (dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number XT59305 (as reported), expiry date: 17-May-2018). On 03-Oct-2017, one day after vaccination, the patient had nausea. On 04-Oct-2017, the patient recovered completely from the event. The reporter assessed the event as non-serious. Significant case correction received with IRD 15-Oct-2017: Vaccination date was changed from 12-Oct-2017 to 02-Oct-2017 in the field.
Dizziness started to occur approximately 9 hours after injection.  Continued to next day.
Gave Shingrix vaccine in right arm with patient standing up, asked patient to sit for flu shot as she said she felt 'woozy'.  After giving the flu shot, I caught her head in my hand as she had passed out. Her eyes were rolling around and she appeared to be gasping for breath. I removed her mask and her lips were blue/white. Her husband was on the other side of her and we were both trying to wake her up. She finally came to and didn't remember passing out but was very dizzy/nauseated. It lasted maybe 30 seconds-1 minute
more than 36 days from first vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination) 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 23-Mar-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 PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 36 days from first vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
This spontaneous report was received from a Licensed Practical Nurse concerning to a 15 year old male patient with a history of infected toe and with no drug reactions/allergies. On 30-JAN-2013, the patient was vaccinated with the first dose of GARDASIL (lot # H009746 and expiration date 11-JAN-2015), intramuscular in the right arm. NO other co-suspect therapy was reported. Concomitant therapies included ZOLOFT and CETIRIZINE HYDROCHLORIDE. The Licensed Practical Nurse reported that on 30-JAN-2013, the patient was administered his first dose of GARDASIL and experienced a knot in right arm, dizziness and headache when he reached his car in the parking lot of physician's office that same day after being administered GARDASIL. Patient immediately returned to the physician's office and treatment at physician's office was a blood sugar by finger stick and vital signs. The result of the patient's blood sugar obtained by finger stick was 76. Vital signs were assessed as blood pressure 117/70, pulse 80, respiratory rate 16 and temperature 97.2. Nurse stated that vital signs were within normal limits for this patient. Patient recovered on 30-JAN-2013. It was reported that the patient did not seek medical attention. Additional information has been requested.
Information has been received from a licensed practical nurse through a Pregnancy registry concerning an 18 year old female who in June 2007 and August 2007 was vaccinated intramuscularly with a 0.5mL first and second dose of GARDASIL.  The nurse reported that the patient was possibly pregnant when she was vaccinated with the second dose of GARDASIL.  On 24-NOV-2007, a pregnancy test was positive.  Follow up information received from a licensed practical nurse revealed that patient received dose one and two of GARDASIL in June 2007 and August 2007.  There was no third dose in their system so the patient never received it at this facility.  She also reported that there was never a pregnancy test done at this facility until 07-APR-2008.  On this date, the patient had a positive test at the office after having two positive tests at home.  Her LMP was 05-MAR-2008.  On 17-APR-2008, she was seen by OB/GYN group.  It was noted at this visit that it was an unplanned pregnancy that occurred on oral contraceptives.  On 28-APR-2008, she was seen for a threatened abortion.  It was noted that at this visit patient was GRAVIDA 1 Para 0 (G1P0).  An ultrasound was done that showed a viable fetus with an EDD of 02-DEC-2008.  On 21-MAY-2008, a placenta previa was noted.  On 12-NOV-2008, an ultrasound was done for growth and weight.  A male baby weighing 6 pounds and 6 ounces was seen.  On 10-DEC-2008, she delivered a healthy boy via C-section.  She said it looked like the patient was induced but she did not have the exact reason for the C-section.  Apgars were 8 and 9 and mom and baby did great.  The licensed practical nurse indicated that , since no pregnancy test was done in their office prior to April 2008 and it was noted that she was G1P0 at the visit in April 2008 then the originally reported "possible" pregnancy must not have been a true pregnancy.  She stated that if there was a pregnancy that had any problems then it would have been in their system.  Upon internal review, threatened abortion and obstetric complication requiring C-Section were considered to be other important medical events.  No further information is available.
The Moderna vaccine was accidentally given to a 17 y.o. male. Vaccine consent was signed and dated by the patient. Patient was contacted 2 times and no adverse or side effects have been reported.
Swelling and redness to right deltoid. No fever or chills. Gradual onset of symptoms. Treatment - Ice area for 20 minutes 3-4 times/day.
pt recv vax 4SEP96 & starting the noc of4SEP96 through 5SEP96 pt exp h/a, stomach discomfort, sore arms, sweating & feeling cold then hot;6SEP96 sx had resolved w/the x/of sl h/a;
This spontaneous report was received from a Registered Nurse (R.N.) concerning some unspecified patients of unknown age and gender. Pertinent medical history and concurrent conditions were not provided. It was reported that some clients "did not tolerate" the vaccine GARDASIL 9 as well as others, (Lot #, dose and frequency not provided). Concomitant medications were not reported. The outcome of drug intolerance was unknown at the time of the report. Additional information has been requested.
IMMUNIZATION GIVEN TOO SOON, PT'S MOTHER BROUGHT PT  IN TO SOON (ON DAY 11 INSTEAD OF DAY 21) FOR 2ND DOSE.  PT'S MOTHER NOTIFIED, MOTHER STATES SHE WILL BRING PT BACK TO CLINIC ON FEB. 24, 2022 TO OBTAIN THE 2ND DOSE.
1 hr p/vax began high pitched screaming lasted off & on 5-6 hrs; called MD & was told it was definite reactions to vax; instructed to give DPH;
5cm x 3cm localized erythematous reaction, warm to touch, 1 day after the injection was given. Treated with Benadryl and cool compresses.
Within an hour I was fatigued, slept a lot, headache and went to bed early. Next morning chills, fever, aches and pains. Two days later, injection site was achy and the rest symptoms went off.  GI problems started before two years ago and then it stopped. Came back in July 2021 and August 2021, like the time of the month from ovulation, cramps and hurts and diarrhea, cramping in my gut.  Went to doctor on August 5, 2021. I thought it was a kidney stone and was prescribed medication for a week via virtual before August 5, 2021. Called my doctor again, prescribed ultrasound. Because the pain was like a stabbing pain. Back pain and pressure inside, minor GI problems which was mild.  I had ultrasounds twice. Exposed to COVID-19 March 2020, may have had COVID-19, I never tested positive. I felt that I had COVID-19.  Back pain, Spleen was enlarged.  Blood test everything was average and couldn't find anything further.  Hematologist scheduled  April through July 2020 Trouble breathing just while walking across the room and now it is better. It came and went. Not consistent.
within 30 minutes of receiving the vaccine I developed a headache.  Woke up in the night with a fever of 101-102 my sinuses were completely congested and very hard to breath.  This condition lasted a full 2 weeks with no improvement.  During this 2 weeks I had two trips to my doctor and one to the ER.  3 COVID tests that all came back negative.  On my second trip to the doctor I took a breathing treatment, this seemed to start to turn things around.  For the following 3 weeks I started to slowly improve with my fever coming and going.  By the end of the 6th week I was finally better.  I have never been sicker, for longer than I was with this 1st dose of the vaccine.
Terrible tightness under left and right arm; Pain in muscles of Buttocks; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE TIGHTNESS (Terrible tightness under left and right arm) and MUSCULOSKELETAL PAIN (Pain in muscles of Buttocks) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, 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 experienced MUSCLE TIGHTNESS (Terrible tightness under left and right arm) and MUSCULOSKELETAL PAIN (Pain in muscles of Buttocks). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, MUSCLE TIGHTNESS (Terrible tightness under left and right arm) and MUSCULOSKELETAL PAIN (Pain in muscles of Buttocks) outcome was unknown.            For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessment.  Concomitant product included blood pressure medicine.   This case was linked to MOD-2021-065210 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow-up document was received on 12-MAY-2021. Reporter's address was added. It contains non significant information.
This spontaneous case, was initially on 13-Dec-2017, from the other health professional, concerning a 50-year-old adult male patient. On 13-Dec-2017, the patient was administered with FLUCELVAX QIV (dose: 0.5ml, route of administration: intramuscular, anatomical location: batch number: 195233 and expiry date: 31-May-2018). It was reported that, vaccine has been exposed to this temperature excursion above 46 F. It was reported that, the patient did not experience any adverse event. The reporter considered this case as non-serious.
Rash and itch at site of injection started a few days after (shot on Oct. 31, 2018 and appeared on Nov. 2nd 2018). Has applied OTC antibiotic cream is little better but still there. Has not gotten worse but not better and still there. Has MD appointment Friday - standard appointment - every 5-6 months. No nodule, flat rash, no knots, has been hot to touch, unsure if fever, denies HA, has dizziness due to vertigo when the front came in, no abdominal, no N/V. Instructed to apply hydrocortisone or oral ZYRTEC, stop NEOSPORIN. Reviewed self-care vaccine side effects to rash that can have symptoms of rash with redness and itching begin 1-4 weeks after vaccination. F/U if rash spreads across body or symptoms last longer than 7 days. Pt. has regular visit with Dr; on Friday, Nov. 16th 2018. Will inform Dr. of rash and contact us if further issues.
This spontaneous report as received from a pharmacist refers to a 62 year old patient of unknown gender. Medical history and concurrent conditions were not reported. On 29-OCT-2014, the patient was vaccinated with a expired dose of ZOSTAVAX, lot # H022152, expiration date 18-MAR-2014. Dose and route were not reproted. No adverse effects had been reported. Additional information has been requested.
Within 1 hour of receiving the vaccine. I started to get a large, hot, red area on my arm. It has gotten worse overnight and is now about 4 inches in diameter. I only received a half dose by my employers health nurse. I was advised today to apply ice to the area and take Tylenol and to report this to your website.
Extended pain in left arm continuing several weeks after vaccine with limited range of motion. Employee saw orthopedic MD; initial treatment was ibuprofen; 2nd visit steroid injection received.
The patient made an appointment for her 1st dose Moderna shot. She checked in with the pharmacy technician to confirm her first dose. She confirm it is the first Moderna dose with the pharmacist. After 15 minutes from receiving her vaccination. She brings out her COVID-19 vaccination card to show the pharmacist she is getting her 3rd dose of Moderna. She received the 3rd doses of Moderna without being moderately to severely immunocompromised,
Patient called the pharmacy and stated that he's having  Hot flashes rest less leg  Sweating  recommended him to go to emergency room.
Shivering, trembling 101.2 degrees Fahrenheit fever Pale lips and face Temporary spots on right hand Nausea
Patient had a vasovagal syncope with administration. Patient stated when he regained consciousness that he has these episodes during all flue shots.
Patient reported feeling "shaky"  after the vaccine, and states she felt like she had trouble "catching her breath."  She states she used her CPAP device and felt better.
Patient came to a flu clinic at the doctor's office. Patient was less than 6 mo. when given 1st flu vaccine. Mom reported only minor cold symptoms.
no adverse event experienced. After administering this dose at a mass vaccination clinic, in the billing process, the insurance rejected payment for vaccine, saying patient had gotten a covid vaccine previously.  Upon further investigation, we discovered patient had received j&J covid vaccine administered at a Pharmacy on 3-11-21.  Patient stated on his vaccine information sheet that he had not gotten a dose previously and that this would be his first shot for covid.
Pt had a localized reaction at the injection site of left deltoid and then generalized hives over the rest of her body including her chin. No respiratory involvement. The employee was given IV Solu-Medrol 125mg in the clinic at 15:55 and sent home at 17:00 with a Medrol dose Pak and Benadryl 25mg po for HS usage. Currently, she is being worked-up by allergy clinic.
Exactly one week after vaccination date injection site has become very itchy and hot. Left arm temp = 98f Right arm injection site 100.5F
The patient experienced erythema, swelling, and warmth of the left upper extremity within 24 hours of vaccination. The symptoms were cellulitis in nature. The patient was treated with Ceflex and Benadryl.
The next day I realized I had difficulty sleeping on my left side as my arm up near the injection site was quite sore. This has continued since that time. I have difficulty raising my arm, lifting anything with that arm and cannot put any pressure on it like sleeping. it is worse during the night. This is continuing since I was given the Fluarix Quadrivalent injection. It was not placed intramuscularly but rather on the soft part of my arm. I have never had any reaction like this before. It is very debilitating. On 11/11/2014 I returned to pharmacy telling them how I was still in pain and asked them to report it. They said they would. I just want to know how much longer this pain will exist and why it happened.
Intense tremors; Tingling tongue; 11/13/21 developed tingling to right side of face, tingling sensation that varies to right side of face. Involves eye,ear,right side of nose , cheek; Fever; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Intense tremors), PARAESTHESIA ORAL (Tingling tongue), PARAESTHESIA (11/13/21 developed tingling to right side of face, tingling sensation that varies to right side of face. Involves eye,ear,right side of nose , cheek) and PYREXIA (Fever) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Nov-2021, the patient experienced TREMOR (Intense tremors), PARAESTHESIA ORAL (Tingling tongue), PARAESTHESIA (11/13/21 developed tingling to right side of face, tingling sensation that varies to right side of face. Involves eye,ear,right side of nose , cheek) and PYREXIA (Fever). At the time of the report, TREMOR (Intense tremors), PARAESTHESIA ORAL (Tingling tongue), PARAESTHESIA (11/13/21 developed tingling to right side of face, tingling sensation that varies to right side of face. Involves eye,ear,right side of nose , cheek) and PYREXIA (Fever) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Nov-2021, Scan: Scans negative for stroke. On 14-Nov-2021, Scan: Scans negative for stroke.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was reported. On 09-Nov-2021 the patient developed fever and intense tremors which lasted for 6 hours. Again on 13-Nov-2021 developed tingling to right side of face and went to ER and stayed overnight. Ever since had been tingling sensation that varies to right side of face which involves eye, ear, tongue, right side of nose, cheek. Intensity varies which may involved one spot or several. The patient did not experienced any additional symptoms/events.  No treatment medication information was reported.
Friday morning (Dec 2, upon waking) noticed soreness in left hand and redness/mild inflammation near injection site.  Fri afternoon had pain in left hand, noticed the pain around 3pm.  Saturday morning (Dec 3) had significant pain in left hand and went to urgent care at local hospital.  IV antibiotics were started (Rocephin) due to swelling of left hand.  IV antibiotics were given 12/3/11, 12/4/11, and 12/5/11.  On 12/5/11, patient saw an orthopedic surgeon who recommended taking ibuprofen to reduce swelling and increasing movement to help increase blood flow and reduce inflammation.  Today (12/6/11, 9:00AM) patient reports the swelling is beginning to go down.  She has another follow-up appt today with the orthopedic surgeon.
Rash with urticaria, hives, fever, pruritis (different from prev rash).
off label use; Booster dose 4; came down with COVID and unfortunately I got it as well; came down with COVID and unfortunately I got it as well.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 75-year-old patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 75 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OFF LABEL USE (medically significant), outcome "unknown"; IMMUNISATION (medically significant), outcome "unknown", described as "Booster dose 4"; DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "came down with COVID and unfortunately I got it as well"; SUSPECTED COVID-19 (medically significant), outcome "recovered", described as "came down with COVID and unfortunately I got it as well.". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.