chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Originates in Sinuses; Tired; Severe Headache & headache comes and go; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe Headache & headache comes and go), SINUS HEADACHE (Originates in Sinuses) and FATIGUE (Tired) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (Severe Headache & headache comes and go). On an unknown date, the patient experienced SINUS HEADACHE (Originates in Sinuses) and FATIGUE (Tired). At the time of the report, HEADACHE (Severe Headache & headache comes and go), SINUS HEADACHE (Originates in Sinuses) and FATIGUE (Tired) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-083106, US-MODERNATX, INC.-MOD-2021-083535 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-083106:Brother case US-MODERNATX, INC.-MOD-2021-083535:Son's case
intense muscle soreness throughout entire body the night of April 13, kept having sinus drainage with blood starting night of April 13 through the day April 14.  Around 8:30 p.m. blood gushed from my nose and my mouth.  It stopped within a few minutes and did not start up again.
Booster Varicella given May 7, 2007.  One day later developed swelling and erythema, warm to touch.  No fevers, no red streaks.  Seen in clinic on May 9 afternoon.  Swelling was 8cm x 8cm, erythema was 5cm x 5 cm, warm to touch.  No evidence of infection.  MOC stated that swelling was resolving by May 9.
I developed shingles.  My husband who received the same vaccine on the same day / time as me also developed shingles 1 month before me (note:  both he and I already had chick pox).  Multiple doctors have told us that there could be a connection between the COVID vaccines and shingles.  One doctor mentioned she has had quite a number of patients who developed shingles after receiving the COVID vaccine regardless of COVID vaccine brand.
This initial spontaneous report was received on 19-JAN-2017 from a female licensed practical nurse (LPN) who reported that multiple unspecified patients "over 14 years of age" received either dose 2 or dose 3 of GARDASIL 9 one to two years after receiving the previous dose of GARDASIL 9 (unspecified dates) which is outside of the recommendations in the GARDASIL 9 prescribing information. The vaccination(s) route, site, Lot #, expiration date and indication were not reported. No adverse effect reported. No further information was reported. Additional information received on 20-JAN-2017, from the same female licensed practical nurse (LPN) reported the date(s) of the administration of GARDASIL 9 for this male (age unknown) were reported to be  1) 31-JUN-2012 and 2) 13-DEC-2016 (Next to this date it is written "(due)". No details provided,) No further information was reported. Additional information has been requested. This is one of several reports from the same reporter. Sender's Comments:  US-009507513-1701USA009269: US-009507513-1701USA009269: US-009507513-1701USA009269.
Symptoms begin the evening of vaccination. Patient had extreme soreness at injection site. Stated he had fever, chills, and joint pain for "a day or two".
Patient called and informed me that he had a rash in his groin area and left inner thigh after he walked his dog.
got vaccinated, it flare up / Suspected vaccination failure; once in a while it flare up; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional case details were reported as follows: The reporter was patient itself. The age at vaccination was not reported. The patient got vaccinated but once in a while it flare up. This case was considered as suspected vaccination failure, as details regarding completion of primary vaccination schedule, laboratory test confirmation and time to onset for shingles were unknown at the time of reporting. The follow up was not required.
Stages violent fever, chills, aches (2 days) next nausea , abdominal cramping, diarrhea, more new aches, weakness,  exhaustion, loss of balance, another round of fever/chills and repeat again of abdominal distress.  This has continued until today (Day 14 since the vaccination.)
on day 7, injection site (upper left arm/shoulder) became itchy with erythema and induration, with soreness in the same  armpit lymph node.  No swelling of lymph node was noticed, only soreness.  Today is day 8 and it is same, less itch, still sore and warm to the touch.  Lymph node still sore, no swelling noticed.
About 12-18 hours after injection, sudden onset of nausea, vertigo, and hearing loss. 10/15/2007 Started taking Antivert 25mg by mouth three times a day for 20 days. When symptoms of nausea, vertigo, and hearing loss, she went to the ER and was referred to an ENT. Doctor determined a sudden onset right vestibular cochlear insult with significant hearing loss. 11/29 Still having problems, noise and pressure still in right ear.
Patient received his covid 19 booster vaccine about 3:10pm. Came in with his 6 family members. After the vaccine was given he walked to another chair to sit and wait for other family members to be done. I was filling out the next patients paperwork and mom noticed that patient had passed out. Mom and myself went to him right away to hold him upright so he didn't fall out of the chair. I went and got my Pharmacist on duty RPh and had her come assist. Once patient came to, Mom, Dad and myself got patient moved to the floor and placed icepacks on him. He was very clammy and warm. RPh took patient blood pressure. He laid on the floor for about 30 minutes while we finished the other vaccines. Once he was feeling better we had some apple juice and gatoraid for him.
Swelling, discoloration (yellow), black/blue where injection was administered, dizziness, area or discoloration is 2.5 inch diameter. Swelling and discoloration still present almost 6 days after injection. Dizziness still present.
Patient is 26-year-old male s/p Anthrax #5 and he reports shortly after getting the Anthrax and Typhoid vaccines (both given same visit) he reports having what appeared as two small mosiquito bites.  These reactions lasted for approximately one day and then resolved on their own.  He reports 1.5 weeks later he had another "bump" that was like a mosquito bite that was itchy.  This bump went away on its own and then 2 days ago patient reports having a red spot on his left arm that was consistent with the area of injection of the anthrax.  Patient reports that he is not sure which vaccine was given over the area that the redness came up.  No fevers, chills, nausea, or vomiting.  He did report recent URI and mild headache.  The pain is described as being in the back of neck and then radiates over the top of the head.  He feels mostly due to recent URI symptoms.  He reports satellite lesions to the best of his knowledge are new too.  Rash is not itchy.  He noticed rash mostly because he saw the rash but not because it bothered him.   He returns today with complaints of itchy rash that is noticed mostly in the morning and resolves on its own.  He reports this rash has been present for the last couple days.  He awakes in the morning with pruritic skin in joints with raised mosquito bites type lesions.  No fevers or chills
Breakthrough case admission after 2 vaccines Pfizer 9/25/21 Lot# Ew0169;  Pfizer 10/16/21 Lot# Ew0179
probably infected by another clinical person or someone; probably infected by another clinical person or someone; This is a spontaneous report received from a contactable reporter(s) (Physician). A child patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. Relevant medical history included: "disability" (unspecified if ongoing), notes: it was a child with disability.  The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "probably infected by another clinical person or someone".  Clinical course: the caller says she has never had COVID until 03Jan, she didnt have alpha and not delta, she was cautious and mindful about what she does then on 31Dec she was exposed when she took off her mask and gloves when she was gave tea and cake on 31Dec, she thought ok fine lets see if she would still be vaccinated. She says the child she was working with showed no sign they had anything, they were happy and smiling and drooling all over the place, it was a child with disability who she knows was probably infected by another clinical person or someone who brought it into the home, the parents and nanny had been boosted with the child, this was when she herself was trying to get her second shot. Caller provides no further information about the patient, patient's parents, or patient's nanny. Caller says that for her husband also had a good positive experience with no allergic reaction to his Johnson & Johnson COVID-19 vaccine, he did have a stroke earlier this year, and has a history of multiple myelomas which is a different cancer, but he had a very good reaction to his vaccine. Caller says she doesnt have time to complete a report on her husband, and would like to be transferred for more information about getting Paxlovid and to find out about the email that she didnt receive yet still. Caller declines to complete a report on her husband. No further details captured, reported, or documented at this time.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Blister on left arm around injection site where flu shot given. Raised, red in color, pt had about 1 week and getting gradually worse.
Headache, body aches (back and shoulder) for 48 hours following vaccination. Persistent tinnitus in the right ear, loud, distracting, impedes sleep and peace of mind. Has not subsided as other symptoms.
Chills; Shaking; Cough; Weakness; This is a spontaneous report received from a contactable Pharmacist.   A 24-year-old male received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ELO140 and Expiration date was unspecified) on 19Jan2021 07:15 as single dose, (at 24 years of age), intramuscular left arm and dose 1 Lot number ELO140 and Expiration date was unspecified) on 29Dec2020 09:00 as single dose, (at 24 years of age), intramuscular left arm for COVID-19 immunisation. Medical history and concomitant medication were not reported. The patient did not have Covid prior to vaccination.  The patient was not tested post vaccination for Covid.  No other vaccine was taken within four weeks. Treatment included Acetaminophen ES. Chills on 19Jan2021 19:00, Shaking on 19Jan2021 19:00, Cough on 19Jan2021 19:00, and Weakness on 19Jan2021 19:00.  Outcome of event chills, shaking, cough and weakness was recovered.   No follow-up attempts are possible. No further information expected.
Insomnia (problem sleeping); can't sleep; insomnia is getting worse; This is a spontaneous report received from contactable consumer from medical information team. The reporter is the patient.  A 71-year-old male patient received BNT162b2 (BNT162B2), on 05Oct2021 as dose 3 (booster), single (Lot number: EW0150) at the age of 71 years intramuscular for COVID-19 immunisation. The patient's relevant medical history included: "Thyroid" (unspecified if ongoing); "Prostate" (unspecified if ongoing); "High blood pressure" (unspecified if ongoing); "Back pain" (unspecified if ongoing), notes: He doesn't think this is due to the vaccine; "Pain on knee" (unspecified if ongoing), notes: He doesn't think this is due to the vaccine. Concomitant medication(s) included: LEVOTHYROXINE taken for thyroid disorder; FINASTERIDE taken for prostate infection; AMLODIPINE taken for hypertension. Vaccination history included: BNT162b2 (DOSE 1; Lot Number: EL3249; intramuscular), administration date: 09Jan2021, when the patient was 70-year-old, for COVID-19 immunization; BNT162b2 (DOSE 2; Lot Number: EL3247; intramuscular), administration date: 30Jan2021, when the patient was 70-year-old, for COVID-19 immunization. The following information was reported: INSOMNIA (non-serious) with onset 15Oct2021, outcome "not recovered", described as "Insomnia (problem sleeping); can't sleep; insomnia is getting worse". The event "insomnia (problem sleeping); can't sleep; insomnia is getting worse" required physician office visit. Therapeutic measures were taken as a result of insomnia.   Additional Information: The patient received the vaccines because it was recommended at a hospital for people who have retired. The Pfizer COVID-19 vaccine has caused the patient insomnia. He received his third COVID-19 vaccine on 05Oct2021 and after a week and a half (15Oct2021) he has insomnia (problem sleeping) and can't sleep and wants to know if Pfizer has a medicine to help him sleep. The insomnia was 12 days after (as reported), and he thought was for one night but started that week of 15Oct2021. He thinks the insomnia is getting worse. Before, he took half an alprazolam (XANAX) to sleep and now needs 1.5 to sleep. The adverse event did not require visit to emergency room. The patient has a doctor and asks for more medicine from the psychiatrist as he is taking 1.5 and sometimes 2 and was told couldn't give him more medicine and he can't afford a private doctor. The patient wanted to know which medication Pfizer recommends treating this problem. They are now recommending the fourth dose, but he is afraid to take another one. The other dose has not been given for fear of more side effects. The patient had no vaccines since then.
Information has been received from a medical assistant (also the site supervisor) referring to unspecified number of patients of unknown age and gender. On an unknown date in March 2015 or April 2015, the patients were vaccinated with improperly stored ROTATEQ orally (dose number, dose and lot# not reported). No symptoms reported. This is one of several cases from the same reporter. Additional information has been requested.
This spontaneous report as received from a pharmacist refers to an unspecified number of patients of unknown ages. On an unknown date, patients were vaccinated with ZOSTAVAX, (lot number, dose and expiration date were not reported) subcutaneous. The pharmacist reported that when he used a 25 gauge 5/8 inch needle (manufacturer of needle unspecified) to administer ZOSTAVAX, the patients (name of specific patients were unspecified) complained that the ZOSTAVAX vaccination hurts. The pharmacist reported that if he used a 31 Gauge 8 mm insulin syringe (manufacturer unspecified to administer ZOSTAVAX the patient's were happy and did not complain of pain. No other information to report. On an unspecified date the patients recovered from the event. Additional information is not expected.
Patient took the Vivotif on 1/22/20, 1/24/20/, 1/26/20, and 1/28/20. On approximately 2/18/20, she began to develop a rash on her arms.  The rash/ hives continue to develop on her arms, hands, neck, back and as of today 2/27/20 continue to appear.  She has had one on her ankle, but mostly arms and back trunk.  They are raised, red, and extremely itchy.  They seem to have a whitish center that "crusts" or "scabs" as it heals.  But so far, new spots appear, but none have gone away completely.  She has no fever or trouble breathing.
Very swollen hands and feet, mimicking RA (Rheumatoid Arthritis). I tested negative for RA.  All joints have severe arthritic pain, except hips. Both are artificial. X-rays showed arthritis in fingers, hands and wrists. Also x-rays on feet showed arthritis in ankles, feet and toes. Arthritis was not an issue prior to the (5th) booster, except for knees and slight in right wrist. I have had multiple (both) knee operations and the reason for the knee arthritis. The reaction after the booster caused sever pain in all joints and made walking difficult as well as difficulty using my arms and hands. The Dr prescribed Celecoxib 200mg for the arthritis, but did not help with the swelling. The Dr prescribed Progesterone after several weeks for swelling and arthritis pain, which resolved swelling and pain quickly. About a week after being off the steroid, the swelling and joint pain returned. However the swelling and joint pain was not as severs and the original flare-up.
Injection site is very swollen, sore,  red, and itchy. About the size of a golf ball.
swelling of rt thigh, fever 100.2 24 hrs p/vax;
Possible allergic reaction with DTaP. Swelling right thigh 10 x 8cm. Right thigh 35cm left thigh 33.5cm. Zyrtec 3/4 tsp QHS. Pediapred 1 tsp BID for 5 days.
Tested positive for COVID starting on April 25, 2022 Initial symptoms of fever and headache; took Paxlovid from April 25, 2022 through April 30, 2022 tested negative on April 30, 2022 symptoms resumed on May 4, 2022 and tested positive again severe congestions through May 10th tested negative on May 15, 16, and 18th
Information has been received from a physician concerning an "approximately 33 year old" female, who in April 2007, was vaccinated with a first dose of Gardasil.  Subsequently, the patient developed a bump at the injection site.  It was reported that the patient was "six or seven months" pregnant and had not received any further doses of the vaccine.  The patient sought unspecified medical attention.  At the time of the report, the patient had not recovered.  No product quality complaint was involved.  Additional information has been requested.
Cellulitis left shoulder vs allergic reaction to Tdap vaccine. Pt unsure if she had pain or edema until 2 days later. She reports pain, and progressive edema, erythema and tenderness in the area. Doxycycline 100 mg BID.
Started out like a red pimple at site. Then whelps developed on face, neck, both arms, inside both legs, and around waist. Both arms swelled, lips swelled. Went to ER when bilateral thumbs developed tight feeling + could not bend thumbs: SOLUMEDROL 125 mg IM given in the ER. BENADRYL 50 mg PO Q4 hour Continue MEDROL dose pack given on Friday 10/01 PO 1Q ER physician.
PRESENTED TO OUR OFFICE 02/13/2008 COMPLAINING OF REDNESS, SWELLING AND PALPABLE LUMP THAT WAS WARM TO TOUCH IN THE AREA WHERE VARIVAX WAS ADMINISTERED 02/04/2008. DIAGNOSED WITH STERILE ABSCESS AND TREATED WITH BACTRIM PEDIATRIC SUSPENSION PO FOR 10 DAYS.
pain on her hand; pain on her heart; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain on her hand) and CHEST PAIN (pain on her heart) 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 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced PAIN IN EXTREMITY (pain on her hand) and CHEST PAIN (pain on her heart). At the time of the report, PAIN IN EXTREMITY (pain on her hand) and CHEST PAIN (pain on her heart) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.   No corrective treatment was provided.
No adverse event; Mother thinks kids received Bivalent booster instead of Monovalent; State's Database shows received vaccine meant for 5M-11-year-old for booster dose; This spontaneous case was reported by a consumer and describes the occurrence of INCORRECT DOSE ADMINISTERED (Mother thinks kids received Bivalent booster instead of Monovalent), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (State's Database shows received vaccine meant for 5M-11-year-old for booster dose) and NO ADVERSE EVENT (No adverse event) in a 12-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Sep-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 17-Sep-2022, the patient experienced INCORRECT DOSE ADMINISTERED (Mother thinks kids received Bivalent booster instead of Monovalent) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (State's Database shows received vaccine meant for 5M-11-year-old for booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INCORRECT DOSE ADMINISTERED (Mother thinks kids received Bivalent booster instead of Monovalent), PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (State's Database shows received vaccine meant for 5M-11-year-old for booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medications were reported. The age of patient was reported as 12.5-year-old. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-647610, US-MODERNATX, INC.-MOD-2022-647577 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-647610:mother case US-MODERNATX, INC.-MOD-2022-647577:Boy child case
Breakthrough COVID Case May 2022 (after being fully vaccinated plus receiving (1) booster in November 2021) - Symptoms: Cough, congestion, aches, and fatigue.  Saw my doctor via  appointment and was prescribed Plaxlovid 300 - 100MG Pack (EUA)  and also took Tylenol, and Mucinex DM.
Almost Passed Out,Dizzy, Light headed,  Blood Pressure and Heart Rate fluctuating, Shortness of breath, some sweating, Fatigue, Nausea,
Approx 3 weeks after second shot, pain, swelling behind rt knee. Went to Urgent Care who sent me to ER.
Joint pain, muscle pain, nausea, headache, fever, decreased urinary output. Saw his physician and was started on antibiotics for UTI.
Fever Injection site soreness Extreme widespread muscle aches & spasms  Widespread joint pain
P/1st dose vax developed fever, wheezing, pharyngitis & flu-like sx x 3 wks; Poss flu or URI; 12hrs post 2nd dose vax developed fever, sore throat, chest congestion, stomach pain, diarrhea & bloody stools;
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and ender. On an unknown date those patients were vaccinated with a dose of improperly stored ROTATEQ (therapy route defaulted to oral, dose, units, lot number were not reported). No adverse effects were noted. This is one of several reports from the same reporter. Additional information has been requested.
Patient arrived at the pharmacy to report that after vaccination with Fluzone HD she developed some blisters in the injection area. She indicated that with the SHINGRIX vaccine she had had another type of reaction. The patient has immunological problems. I pointed out to her that there might be a possibility that her immune problems might have had something to do with his reactions. You were instructed to see your doctor first before receiving any other vaccinations in case you need any medications or actions prior to vaccination. She was very appreciative of the care provided.