chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This is a follow up report to VAERS report 259546, and is regarding the second shot of COVID vaccine.  The first shot I had a bad rash 14 days after receiving the vaccine.  This was treated with Benadryl and hydrocortisone and within two weeks, it was almost gone. Therefore, I was advised by my doctor to get the 2nd shot in the other arm.  Within 24 hours of the second shot, the same rash broke out from shoulder to elbow that happened after the first shot. In addition, at the same time, my right armpit gland became very swollen and sensitive to the touch.  Doctor advised to again use Benadryl for 48 hours and hyrdocortisone.
No Adverse event; 13 elderly patients received a 2nd Bivalent booster on 16DEC2022, 2 months after the first Bivalent booster; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (13 elderly patients received a 2nd Bivalent booster on 16DEC2022, 2 months after the first Bivalent booster) and NO ADVERSE EVENT (No Adverse event) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7162B) for COVID-19 prophylaxis.     No Medical History information was reported.   In October 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 16-Dec-2022, received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to 1 dosage form. On 16-Dec-2022, the patient experienced EXTRA DOSE ADMINISTERED (13 elderly patients received a 2nd Bivalent booster on 16DEC2022, 2 months after the first Bivalent booster). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXTRA DOSE ADMINISTERED (13 elderly patients received a 2nd Bivalent booster on 16DEC2022, 2 months after the first Bivalent booster) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessment was provided for EXTRA DOSE ADMINISTERED (13 elderly patients received a 2nd Bivalent booster on 16DEC2022, 2 months after the first Bivalent booster).    No concomitant medications were reported.  Pharmacist called to report that the patient received a 2nd Bivalent booster on 16-Dec-2022, 2 months after the first Bivalent booster. All vials thawed on 16-Dec-2022.   No treatment drugs were reported.  This case contains information for the 9th of 13 elderly patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2022-688372 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-688372:master case 1 of 13
Following Dose 1,  Right Arm became sore at injection site for 4 days, at which time Right armpit became very tender touch and was swollen about size of silver dollar, approx. 1/2 inch thick.  Soreness at injection site subsided over the next 17 days, but tenderness in armpit only diminished slightly.  Following Dose 2, Right Arm was once again sore at injection site for about 4 days, but tenderness to the right armpit became more pronounced, with swelling increasing to the size of a hockey puck.  Size of swelling was easily visible to the eye.  Armpit became more tender to the touch, and has diminished only slightly in size,, as of this reporting.  Mass remains soft to the feel, but easily defined in size and location.  I have taken OTC pain killers to help with the discomfort.  Will continue to monitor its progress, unless notified otherwise.  Do not anticipate seeing my physician at this point.  Have consulted the Web, and have noted that this is a lesser side effect of this vaccine, if swelling remains localized to the injection site.  Thought I should report this side effect only because of the size of the swelling that occured.
pt experienced burning sensation on injection site, body aches and joint pain, took Tylenol for these symptoms. Also experienced taste alteration for over 3 weeks now
Had acute onset of fever, rash and joint swelling about 9 days after her MMR and varicella immunizations.  By review of chart records and discussion with the family, she appears to have had a "serum-sickness"-like reaction.  She was also on amoxicillin at the time of the illness.  After her hospitalization, she developed a sensorineural hearing loss which has persisted. 4/27/07 Received medical records from outpatient clinic From 6/04 thru 11/05 which reveal patient experienced delayed speech, hearing loss, frequent bouts of OM, frequent loose stools which responded well when changed to soy milk.  PE tubes were placed 12/04 but patient continued w/frequent bouts of OM.  Several audiology examination did reveal sensorineural hearing loss, w/abnormal tympanogram & speech delay.  Received Speech Tx. Fitted for hearing aids 5/05.  Speech improved w/treatments.  PE tubes had to be reinserted & had adenoidectomy at same time.   FINAL DX: Sensorineural hearing loss, delayed speech. 7/17/07 Received hospital medical records dated 6/19-6/21/2004. Admitted for diffuse erythematous indurated rash, bilateral knee & ankle swelling, facial puffiness, nasal discharge & fever.  No D/C summary available. FINAL DX: Fever, rash & joint swelling. 1/4/10 Bilateral Sensorineural hearing loss requiring hearing aids.
pt recvd vax; 5apr95 & 14aug95 non-responder
Immun given 04AUG92; 1 dose APAP given; became very fussy w/inc t102 about 5PM; crying since then; vomited feedings; APAP given 9AM & 1145AM; still crying, t99.3 today & very fussy; gave APAP elixer, not APAP gtts;
I started having chest pain palpitation Tuesday night and wasnt able to sleep.  Wednesday, body ache, and headache all day.  Thursday headache still there but manageable.  Friday no problem.  Saturday, felt differently but ok... Sat around 5:50pm started to feel lightheaded, I tried to walk to my bed to lay down  and fainted and hit the floor. I woke up on the floor confused and realized on what had happened.   Chest tightness continues and back of the head still hurts as of today and exhaustion persists, Tuesday 4/13.
side effects; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION COMPLICATION (side effects) 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 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 VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided. Treatment information was not provided.
Received Gardasil #3 about 4 PM. Next AM red pruritic rash on forehead which spread to cheeks. Swelling around eye (mild) and cheeks.
Information was received on 05-JUN-2017 from a company representative regarding a 13 month old female child who was born prematurely at 33 weeks gestation. The physician told the representative that the patient was given VARIVAX (lot# M024675, expiration unknown) 0.5ml one time to prevent chickenpox on 18-APR-2017. The patient was brought to the physician's office today (05-JUN-2017) with chickenpox that began "a couple days ago". The patient had about 10 lesions and was otherwise healthy. Unspecified treatment was given to patient for chickenpox. Outcome of chickenpox was unknown. No additional adverse event information was provided. Additional information has been requested.
Severe chills and fever with tachycardia and hypertension started about 2 hours after the vaccine adminstration. Pt called MD office they were closed, went to Emergency Room and many tests were done. Pt was told that it was a reaction to the vaccine.
At 24 hours, had fever of 100 degrees. Felt mild pain in numerous joints. All this subsided over the next 8 hours except pain in right wrist which persisted and got much worse. That pain has continued (now day 5). Most noticeable when attempting to open a jar.
This spontaneous report was received from a Licensed Practical Nurse referring to an unspecified number of patients of unknown age and gender. Pertinent medical history, concurrent conditions and concomitant medications were not reported. On unknown dates, the patients were vaccinated with doses of VAQTA (lot number and expiration dates not reported) for prophylaxis, which were improperly stored at >46°F but < 77°F for 15 minutes. No adverse effects were reported. There were no previous temperature excursions and call was done because of a data logger. No further information was provided. This is one of 5 reports from the same source. Additional information has been requested. Sender's Comments: US-009507513-1701USA009556: US-009507513-1701USA009569: US-009507513-1701USA009571: US-009507513-1701USA009572.
Warm at injection site; Itching at injection site; Red at injection site; Swelling at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Warm at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     No medical history information reported.   Concomitant products included CALCIUM, MULTIVITAMIN [VITAMINS NOS] and ANTIDEPRESSANTS for an unknown indication.    On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm at injection site), VACCINATION SITE PRURITUS (Itching at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling at injection site). The patient was treated with CALAMINE, GLYCEROL, ZINC OXIDE (CALAMINE LOTION) for Itching, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Warm at injection site), VACCINATION SITE ERYTHEMA (Red at injection site) and VACCINATION SITE SWELLING (Swelling at injection site) outcome was unknown and VACCINATION SITE PRURITUS (Itching at injection site) was resolving.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
On Thursday, Oct 26th, patient was showing some slight rashes that grew and continued to spread over his whole body. We took him to the ER and at 9:30PM he was given a dose of Prednisone and BENADRYL. The following morning his symptoms look like they had gone away.
Leg has a red wwollen area over thigh & below knee; Child had a high pitched cry off & on 230 to 11PM whenever the Tylenol wore off. Fever was 103; Child slept during night.
She did not have an adverse reaction to the vaccine. She tested positive for COVID-19 on 04/28/2023. She was having trouble breathing and low oxygen level. She went to the hospital for eight days. She was discharged from the hospital to a residential facility for physical therapy due to Alzheimer's Disease.
*ADMINISTRATION ERROR*  12 y/o female received her COVID-19 vaccine (Pfizer) booster on 1/8/2022. Her mother visited the vaccination center today, 1/11/2022, to notify that her daughter had received her vaccine before her recommended date, approximately 1 month before. Her second dose was administered on 9/2/2021 and based on most recent CDC guidelines, it is recommended that she wait 5 months before receiving her booster dose. In her case booster dose should have been administered no sooner than 2/2/2022. The event was notified and properly documented.
Multisystem inflammatory syndrome in children; fever started 24 hrs lasted for 80 hours ( range from 101-103.5); vomited 2 times; diarrhea on Monday and Tuesday; rash and its getting worse; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 13-month-old male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) at the age of 13 months for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: RASH (non-serious) with onset 19Jul2022, outcome "unknown", described as "rash and its getting worse"; MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (medically significant), outcome "unknown", described as "Multisystem inflammatory syndrome in children "; PYREXIA (non-serious), outcome "recovered", described as "fever started 24 hrs lasted for 80 hours ( range from 101-103.5)"; INFANTILE VOMITING (non-serious), outcome "unknown", described as "vomited 2 times"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea on Monday and Tuesday". The patient underwent the following laboratory tests and procedures: Body temperature: 101-103.5, notes: So that was 80 hours of fever between 101 and 103.5 approximately. Clinical course: Caller's son who is 13 months old got the Covid vaccine on Friday at doctor's office. He had fever that started 24 hours after getting the vaccine and then lasted until last night. So that was 80 hours of fever between 101 and 103.5 approximately. He vomited twice, once on Sunday and once on Monday. He had diarrhea on Monday and Tuesday and then he started getting rashes yesterday. Rashes are getting worse. Has rashes in a lot of places today. Caller was wondering if there was any information on if this is normal. He also stated that he read 2 % of the people who have received the Pfizer covid vaccine have experienced Multisystem inflammatory syndrome and rash. Identification of the case safety report Serious: No.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
4 loose stools green in color x 2 weeks. Developing dairy intolerance requiring breast fed mom to remove dairy from diet to continue to nurse pt.
Nurse went to draw up dose of Pfizer out of the vial and it was found that there were not the complete four doses that should have been in there. Two doses had been given out of the vial. Nurse that found error notified county nurse manager and an investigation was completed to see who received the two doses that were taken out of the vial. It was determined that nurse that prepared Pfizer during diluting only diluted with 0.8ml instead of the correct amount of 1.8 ml. Vial was disposed of and nurse was re-educated about drawing up the Pfizer vaccination. Pt was called and informed of incident and encouraged to monitor or any adverse reaction. Pt was also informed that no additional doses would be needed or given.
A few days after the shot, I noticed there was swelling at the injection site.  Not painful, but feels like a lump is in my arm.
Fever (102F for 24hrs), whole body muscle pain, headache, injection site pain
I started getting starbursts in my eye, even when driving at night. The sunlight was giving severe headaches. I cannot handle any bright light. And I am still suffering from headaches. I went to see an eye doctor the week of November 22nd 2022 and he found I had hole Macular Hole in my right eye. I was then referred to see the Dr. at a local eye center. I have to have Macular Hole Repair in the right eye on March 3, 2022. About mid December I was preparing for my eye surgery and had to lay face down 15 hours a day. I was vomiting when lying face down. I was spontaneous vomiting whenever I was laying on my back. I call Dr. and he said I had to have a upper GI. He found a sliding hernia, and said I needed surgery. I had the surgery on January, 19th 2022.
Patient developed adverse reaction about 5 minutes after vaccine was given.  He complained of sharp, shooting pain all over his body and joints.  Patient also had difficulties standing and walking because of general weakness.
vaccine 10/4 12:45 sick 10/9  Monday in am - dry cough. Took ibuprofen and stayed in bed 3 days 10/9-10/11. Better Thursday 10/12. Worse 10/13 with fever and cough. Very sick 10/14 with fever, extremely sore throat, heavy running nose and congestion. Take multiplel ibuprofin and stay in bed.  Worse Sunday 10/15 - more bed rest and ibuprofin and hot liquids. 10/16 better, go to Urgent care and get virus lab test - receive results 10/17 POSITIVE for RSV. 10/17 bad fatigue, congestion, throat and cough better with Advil Cold and Sinus, but fatigue worse. Today 10/23 still bad fatigue, dry cough, congestion.
Information has been received from a physician for GARDASIL, a Pregnancy Registry product, concerning a female patient who on an unspecified date was vaccinated with the first dose of GARDASIL. The physician reported that on an unspecified date the patient came late for the second dose of GARDASIL, she was pregnant (LMP and EDD was unspecified) and had an abnormal pap smear. At the time of the report, the patient outcome was unknown. Additional information has been requested.
Local reaction on left upper arm, mildly indurated, red and warm to touch. Measures 65 cm x 54 cm.
8/2/2019 First time HPV vaccine was adminustered today, concurrent with TDAP (not a first time vaccine). Patient reported no reactions after administration. Was advised to stay in the store area for 15 minutes to be monitored. Patient was checked out at 9:44 AM.   Patient started walking towards the pharmacy with mother and other sibling. Then after about 2-3 minutes ( about 5 minutes after patient left the clinic, approximately 0949 AM), pharmacy called me and said that the patient was having a bad reaction to the vaccine.   Provider immediately went to assess patient, who was currently sitting down in front of the pharmacy. Pharmacist asked to call for EMS. Parent states patient complained she was not feeling good, suddenly felt queasy in the stomach, clammy and sat down. Patient alert oriented, but lethargic. No signs of respiratory distress, rash. Patient denied scratchy itchy throat, chest pain, shortness of breath, throat swelling.   @0949 Vital signs obtained:  Temp=98.7 F HR = 74 BP = 90/60 02 saturation 96%   @0954 EMS en route Patient maintained alertness, but still weak. States she is feeling better, assisted to go back to the clinic. Steady gait, denies any dizziness, and patient  continued to deny: scratchy itchy throat, chest pain, shortness of breath, throat swelling. Color is now normal. Assisted to the chair. Vital signs obtained: Temp= 97.1 F HR=71 BP=90/60 O2 saturation 98 %   @0958 EMS arrived Handed over care to EMS dispatch team Patient assessed Vital signs by EMS team: HR=88 O2 saturation 100% BP= 90/50   EMS team leader discussed options with mother. Mother refused patient to be transported to ER. Patient states she is feeling better now. Parent signed refusal to be transported.   EMS left. Patient assisted to vehicle. Mother states patient has not had anything to eat yet for breakfast and may have contributed to the reaction. Parent advised to seek emergency care as soon as possible if patient reports not feeling good again. Parent verbalized understanding of instructions.   @1255 PM Called up parent to follow up on patient. Parent reports that patient's arm is sore, but ate some food and drank fluids. Color is back to normal, not clammy anymore and denies any stomach pain/N/V/D after eating. Parent sates patient is feeling "okay".   Parent advised to seek emergency care as soon as possible if patient reports not feeling good again. Parent verbalized understanding of instructions.   8/3/2019 @0909 Courtesy follow up call. Unable to reach parent. Advised to seek higher level of care if any of patient's symptoms recur. Advised to call Patient support for any questions or concerns.
Patient was given pneumococcal polysaccharide vaccine and pneumococcal conjugate vaccine on the same day. Patient does not report any adverse events. We emailed the CDC to find out if vaccines needed to be repeated. Per CDC recommendations they stated to report error to VAERS.
6 days following the injection in the left deltoid, it became inflamed being that it is swollen, and warm to the touch.  I got that deep down to the bones chill.  In addition, my skin on my face, arms, abdomen and legs became hypersensitive, felt like it was burning.
Ceased Bm's only produced smallamounts that looked like tarry blackrabbit turds; Begin losing intestinallining; sticky mucous; This is a spontaneous report received from a contactable consumer, the patient. A 59-year-old non pregnant female patient received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown, Right Arm) via an unspecified route administration on 19Mar2021 at 11:00 AM (at the age of 59-year-old) as a single dose for COVID-19 immunisation. Medical history included as herniated disc or sinus. Patient had allergy with celecoxib(CELEBREX) on unknown date. The patient took  vitamins nos children's chewable vitamins within 2 weeks of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient experienced ceased bowel movements and produced small amounts that looked like tarry black rabbit turds, begin to lose intestinal lining, dropped out in chucks as big as two and a half inches long and one inch wide or seeps out in pools of sticky mucous. Patient reported to have to wear a diaper so as to not to make a mess and there was no controlling it. The adverse event resulted in doctor/healthcare/clinic visit. The patient did not received any treatment for the event. The clinical outcome of the events was not recovered at the time of report. No follow-up attempts are possible; information about lot number cannot be obtained.
Patient described kidney pain for a few hours and she was freezing and her teeth were chattering for 2 hours. She stated that adverse effects resolved and she stated she has an upcoming appointment with her nephrologist.