chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a physician concerning a 12 year old female patient with no medical history who in January 2007, was vaccinated IM with a 0.5ml dose of Gardasil. One to two days after receiving her first and second dose, the patient developed pain and weakness to both upper limbs. Then 10 to 14 days later, she developed soreness and stiffness to both elbows. It was reported that this discomfort lasts for about 4 days and then resolves. It was also reported that the patient's mother has multiple sclerosis. Unspecified medical attention was sought. At the time of this report, the patient was recovering from pain and weakness to both upper limbs. No product quality complaint was involved. Additional information has been requested. This is in follow-up to report(s) previously submitted on 7/16/2007. Initial and follow up information has been received from a physician, concerning a 16 year old (previously reported as 12 year old) female student with no medical history and no illness at the time of vaccination, who on 10-NOV-2006 was vaccinated with the first dose of GARDASIL (lot #653938/0954Y). On the same day (previously reported as 1-2 days later), the patient developed weakness in her arm (previously reported as to both upper limbs). She recovered from the weakness the following day. Then 10 to 14 days later, she developed soreness and stiffness to both elbows that resolved after one day (previously reported as duration of 4 days). It was also reported that the patient's mother has multiple sclerosis. Unspecified medical attention was sought. On 10-JAN-2007 the patient was vaccinated IM with the second dose, 0.5ml, of GARDASIL (lot #655619/1427F). As with the first dose, she developed weakness in her arm that resolved the next day- And again 10 -14 days later, she developed soreness and stiffness to both elbows that resolved after one day. On 10-AUG-2007, the patient was vaccinated with the third dose of GARDASIL (lot # invalid). Following this vaccination, the patient did not experience any symptoms. Additional information is not expected.
I have a lump under my armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AXILLARY MASS (non-serious), outcome "unknown", described as "I have a lump under my armpit". Additional information: Patient reported to have received the first shot on the 25th (not specified). The patient has not received the second shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Child awoke with body aches, sore muscle, sore throat, neck pain; rapid strep positive. Treated with Cefzel.
Myalgia, Arthralgia, chills, fatigue, SOB Narrative: still feeling ill
itchy/It is a pretty big area; tender, sore at the injection site; redness and tender, sore at the injection site; warm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (itchy/It is a pretty big area), VACCINATION SITE PAIN (tender, sore at the injection site) and VACCINATION SITE ERYTHEMA (redness and tender, sore at the injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 030L20A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Gout and Hypertension. Concomitant products included ALLOPURINOL for Gout, PARACETAMOL (TYLENOL), INSULIN and ASPIRIN [ACETYLSALICYLIC ACID] for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PAIN (tender, sore at the injection site) and VACCINATION SITE ERYTHEMA (redness and tender, sore at the injection site). On 16-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy/It is a pretty big area). At the time of the report, VACCINATION SITE WARMTH (warm to the touch), VACCINATION SITE PRURITUS (itchy/It is a pretty big area), VACCINATION SITE PAIN (tender, sore at the injection site) and VACCINATION SITE ERYTHEMA (redness and tender, sore at the injection site) had not resolved.            Concomitant medications included blood pressure pill and diabetic medication. No treatment information was reported. The action taken for mRNA-1273 was not applicable.
Jule 2022---Heart racing, High Blood Pressure, numbness and tingling in both legs, feet on fire, heat on the back of the neck & head, behind ears and blurred vision. Tightening of leg muscles to the point of not being able to walk. Both arms and hands shaking  and tingling. Pressure in nose, Tinnitus, ears pop, dizzy and brain fog.
Child developed rash to body on 6/28/2007, during the morning. Non itchy rash, low grade fever and cold, diagnosis. Benadryl and Ibuprofen ordered. Lab work done.
(Radial nerve neuritis per MD) - c/o right arm numbness and tingling 1 1/2 hrs. after vaccine.  9/25/09 pts feeling better
This spontaneous report as received from a field employee, an acquaintance with the patient. The report refers to a 74 year old female patient with drug reactions/allergies for Beta Blockers. The patient received her first pneumonia vaccination (manufacturer unknown) at age 64 years of age (assumed in 2003). On 13-SEP-2013 at 12PM the patient was vaccinated with PNEUMOVAX 23 (dosing information and route are unknown). Concomitant therapies included WARFARIN and Calcium Channel Blocker. The field employee reported that the patient told her she had received a PNEUMOVAX 23 injection and afterward her arm was very sore and painful. The patient told her she felt "lousy" and had to stay in bed for three days. Follow up information was received from the patient. The patient reported that she developed a "total knock down reaction" to PNEUMOVAX 23 injection. She stated that later that evening, on 13-SEP-2013, her arm had begun to feel very heavy. The patient then stated that by that afternoon the arm had developed intense pain from the injection site and spread into her tendons. The patient attempted to treat the pain with TYLENOL with was unsuccessful. The patient then stated that by that night the pain was so intense it became hard to sleep, and afterward she also developed ice-cold sweats and nausea. The patient explained that the entire reaction occurred over a 4 day period with 1.5 days of intense pain, and the remaining time with lingering pain in her tendons and forearm. The patient present status was reported as recovering/resolving. No reporter causality provided. Additional information has been requested.
Adverse Reaction Notes: Per NP. Patient had a brief syncopal episode after receiving Johnson and Johnson vaccine , his vital signs remained stable BP 121/76,P68,O2 sat 99%. Patient was awake ,alert, oriented x4,he left vaccination site via ambulance with paramedics to hospital for further evaluation.
Next day could hardly move his arm. Ongoing aching when moves his arm. Difficulty sleeping due to pain. Still having pain 21 days later but improving
Shot given 10:19pm on 2/6/21.  Noticed rash on 2/8/21 11:55am.  Rash was bilateral on face along madibles from TMJ to about 1" from lips and was 2" superior from jaw line towards the eyes.  Rash was very red over skin area with multiple darker spots and by 2/7/21 those spots appeared open though no blisters or pustules were seen.  Rash had burning sensation which was relieved by Vaseline.  Once doctor was seen (PA),  Tacrolimus ointment was prescribed BID.  Rash no longer burns 2/9/21 pm and it appears to be resolving.  Spots are still evident but erythemic area is gone.
Injection site pain, arm tenderness, fever, muscle and joint aches, headache. Began quickly at onset, about 12 hours after vaccination. Was bothersome enough to prevent sleep. Began to diminish about 12 hours after onset, or about 24 hours after vaccination.
100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again; No Adverse Event; Poor quality vaccine administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ) and NO ADVERSE EVENT (No Adverse Event) in an adult male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On 11-Jan-2023, 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 11-Jan-2023, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and NO ADVERSE EVENT (No Adverse Event). At the time of the report, PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again), POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ) 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)) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessments were provided for PRODUCT STORAGE ERROR (100 bivalent boosters were given yesterday from vials that were put in the fridge and after that refrozen and thawed again) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality vaccine administered ).    No concomitant medicine were reported. No treatment medicine were reported. This case was for 29th out of 100 patients reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-697752 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-697752:MASTER CASE
gave 15 patients expired Flublok vaccine with no reported adverse event; Initial information received on 15-Oct-2021 regarding an unsolicited valid non-serious case received from a consumer/non health care professional via Medical Information number: 00814729.  This case is linked to cases 2021SA345109, 2021SA344107, 2021SA344343, 2021SA345067,2021SA345249, 2021SA345086, 2021SA345823, 2021SA345587, 2021SA345419, 2021SA345624, 2021SA345617, 2021SA345099,  2021SA345624, 2021SA345099, 2021SA345067 and 2021SA344898 (CLUSTER).  This case involves a 48 years old female patient who was administered an expired dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (expired product administered).  The patient's medical history, past medical treatments, vaccinations, concomitant medications and family history were not provided.  On 03-Sep-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number: QFAA2017 and expiry date: 30-JUN-2021 via intramuscular route in unknown administration site prophylactic vaccination  It was case of an actual medication error due to expired vaccine used (latency: same day).  At the time of reporting, 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 the 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.
Reaction in the arm of the injection site; Red and bulge area form covering a pretty big area of upper arm; Red and bulge area form covering a pretty big area of upper arm; When it started to dry, it itched a lot; The mark is still visible; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FD8448) via an unspecified route of administration in the left arm on 21Aug2021 at 13:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient's medical history and known allergies were reported as not applicable. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and unspecified vitamins; both from unknown dates, for unknown indications and unknown if ongoing. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 21Aug2021 at 22:00 the patient experienced reaction in the arm of the injection site. Red and bulge area form covering a pretty big area of her upper arm. The bulging went down first, then the redness. When it started to dry, it itched a lot. The mark was still visible in her arm. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events reaction in the arm of the injection site, red and bulge area form covering a pretty big area of her upper arm, when it started to dry, it itched a lot was resolved on an unknown date in 2021 and while that of the mark is still visible was not resolved. The patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FC3184) via an unspecified route of administration in the left arm on 11Sep2021 at 14:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation.
I have a lifelong affliction with migraine, with aura. I only get them 1-2 times a year, and they follow the classic migraine pattern. I got a rare one the week after my second Pfizer bivalent booster which was offered to autoimmune patients. Migraine had 24 hours of feeling groggy, a half hour vision loss aura, and a half hour speech aphasia, followed by left sided moderate brain pain over the next 36 hours.   It was not severe, I have had much worse ones from cleaning chemicals or foods. It was unusual in the timing and seemed to have been vaccine triggered. I was also in a significant amount of muscle pain and fatigue with this booster the week following.
fever; chills; body aches; muscular pain; severe headache; This is a spontaneous report from Contactable Physician (patient) via Pfizer Sales Representative.   A 63-year-old male patient received bnt162b2 (Pfizer BioN Tech Covid-19 MRNA vaccine, Formulation: Solution for injection, Batch/Lot number: Unknown) via unspecified route of administration as Dose 2, Single on an unspecified date for Covid-19 immunisation. The patient' medical history which include Lipoprotein a little high, on a statin to lower effect on plaque buildup. Concomitant medication was not reported. Historical vaccination included the patient received bnt162b2 (Pfizer BioN Tech Covid-19 MRNA vaccine, Formulation: Solution for injection, Batch/Lot number: Unknown) via unspecified route of administration as Dose 1, Single on an unspecified date for Covid-19 immunisation.Within eight hours of receiving second dose, the patient experienced fever chills, body aches muscular pain and severe headache, on an unspecified date for almost 24 hours. Outcome of all event was unknown.  No follow-up attempts are possible. Information about batch/Lot number cannot be obtained
Fever, chills, muscle spasms, sore throat, fever blisters over lips, swollen lymph glands, ear pain, severe fatigue
I felt no pain after shot. Went to sleep around 8pm  woke up at 10pm to find my vision was blurry.  I went back to bed and woke up 7am with sore left arm, body ache, head ache and blurry vision.  It?s hard for my eyes to focus on things, light hurts my eyes and it?s blurry
bruising; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruising) and PAIN IN EXTREMITY (arm pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, the patient experienced CONTUSION (bruising) and PAIN IN EXTREMITY (arm pain). On 08-Feb-2021, PAIN IN EXTREMITY (arm pain) had resolved. At the time of the report, CONTUSION (bruising) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Reporter did not allow further contact
decreased range of motion two weeks post Flublok injection; left arm soreness; Initial information received on 04-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-health care professional.  This case involves an 89 years old male patient who received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and experienced left arm soreness (musculoskeletal pain) and decreased range of motion two weeks post Flublok injection (mobility decreased).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 23-Sep-2019, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE lot number not reported via intramuscular route in the left deltoid.  On an unknown date, following the vaccination the patient experienced left arm soreness (musculoskeletal pain) and decreased range of motion two weeks post Flublok injection (mobility decreased).  (Other relevant tests included no lab data.)  Final diagnosis was mobility decreased and shoulder soreness.  It was not reported if the patient received a corrective treatment.  The outcome of the event was unknown at the time of reporting.  Information on the batch number was requested.  List of documents held by sender: none.
On 01/09/2021-swelling on the injection site redness and itching, symptoms resolved on 01/11/2021. Today 01/17/2012 at 08:30a.m I woke up with redness at the injection site mild swelling and itching
Patient developed a large pustular rash around the smallpox vaccination site. Patient also complained that during this timeframe he also developed a low grade fever. Doctor treated patient with Sulfamethoxazole + Trimethoprim, (SEPTRA DS), Tablet, Oral TAKE ONE TABLET BY MOUTH EVERY TWELVE HOURS TILL ALL TAKEN FOR INFECTION, Acetaminophen 325mg and Ibuprofen 400mg and instructed to follow up on 22 January 2018.
2/22 vaccination  3/3 BP increased to 160/110, blood panel to check kidney and liver function, markers for preeclampsia. To come back the following week for follow up.  3/10 My BP was still high. Non stress test. 24 hour urine collection.  3/12 Called by Dr office to induce labor.  2 doses of BP medicine in IV, magnesium, heartburn.  Daughter born at 6am. 8lb 1 oz.  11 days postpartum; couldn't stand up. Fever of 103. ER; blood cultures, pelvic exams.  COVID swab. Chest xray. All neg. Post partum uterine infection. Put on antibiotic 4/14/2021 baby administered for failure to thrive.  6th pregnancy. 5th live birth. Estimated date of delivery 3/25/2021.
Evening after getting shot I got super dizzy, which in turn, made me feel nauseous.  Ending up taking dramamine and tylenol, which helped alleviate the dizziness. Went to bed and woke up with no dizziness. Also had the typical side effects of headache and body aches the next day.
FLU SYMPTOMS; DIARRHEA; COLITIS ATTACH; VOMITING; LOSS OF TASTE; LOSS OF SMELL; RASH; SORE ARM; MYALGIA; IMMUNITY DOWN; This spontaneous report received from a patient concerned a 56 year old female. The patient's height, and weight were not reported. The patient's past medical history included covid-19 infection, and concurrent conditions included alcohol allergy, and codeine allergy, and other pre-existing medical conditions included the patient was not pregnant at the time of vaccination. The patient received covid-19 vaccine  (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAY-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the subject experienced immunity down. Laboratory data included: Antibody test (NR: not provided) Positive. On 03-MAY-2021, the subject experienced flu symptoms. On 03-MAY-2021, the subject experienced diarrhea. On 03-MAY-2021, the subject experienced colitis attach. On 03-MAY-2021, the subject experienced vomiting. On 03-MAY-2021, the subject experienced loss of taste. On 03-MAY-2021, the subject experienced loss of smell. On 03-MAY-2021, the subject experienced rash. On 03-MAY-2021, the subject experienced sore arm. On 03-MAY-2021, the subject experienced myalgia. The action taken with covid-19 vaccine was not applicable. The patient recovered from rash on 04-MAY-2021, was recovering from flu symptoms, colitis attach, vomiting, and myalgia, had not recovered from diarrhea, sore arm, loss of taste, and loss of smell, and the outcome of immunity down was not reported. This report was non-serious.
Pt presented to clinic one week after flu shot. Two days after flu shot developed cold like symptoms, Developed generalized body swelling, tender scalp including temples, gained 10 pounds in one week, Vision dimmed off and one, temples feeling swollen, No difficulties with swallowing or loss of strength. Initial labs normal including normal ESR and Sed Rate. Patient returned with continued symptoms. Prednisone started with much improvement in symptoms. Continued prednisone for about a week, symptoms went away. Prednisone stopped and some symptoms returned especially temple swelling and vision changes. Patient had normal exam with Opthalmology. On 12/31/19 CRP was 15.7 off prednisone. Patient elected not to have biopsy of temporal arteries as symptoms bilateral. Patient now being treated for possible Temporal Arteritis / Giant Cell Arteritis.
pt exp vertigo, nausea, diarrhea x3, lasted approx 5 hrs; then states 24 hrs of 'total exhaustion,','states low grade fever also.'
ON 11/11/08 AT 5 PM I RECEIVED THE FLU & PNEUMONIA VACCINE. BY 3 AM THE NEXT DAY THE ARM WITH THE FLU VACCINE WAS VERY SWOLLEN AND UNUSUALLY SORE.  LATER THAT DAY I STARTED RUNNING A FEVER,CHILLS AND RASH ON MOST OF THAT ARM.IT LATER SPREAD TO MOST OF MY TORSO. IT DIDN'T ITCH. THIS LASTED FOR MORE THAN 3 DAYS.  I TOOK IBUPROFEN & BENADRYL REGULARLY DURING THIS TIME. DIDN'T HELP MUCH.
One week post vax pt developed two swollen bumps the size of a half dollar on each leg with blisters around one of the bumps on the left leg.