chrisvoncsefalvay/vaers-outcomes huggingface dataset:
brain swelling; patient had localized reaction; Initial information received on 14-Apr-2023 regarding an unsolicited valid serious case received from a other health professional.  This case involves a 9 months old female patient who experienced brain swelling and patient had localized reaction after receiving vaccine Influenza USP Trival A-B Subvirion Vaccine [Fluzone].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 30-Oct-2003, the patient received an unknown dose (dose 1) (Dose = 0.25 mL to 2 mL for vaccines or 0.1 mL for TB skin test = 0.5 ml) of suspect Influenza USP Trival A-B Subvirion vaccine Suspension for injection (Strength = standard) of lot U1102AA and expiry: Jun-2004 via unknown route in the left thigh for immunization.  On an unknown date, the patient developed a serious event brain swelling (brain oedema) (unknown latency) following the administration of Influenza USP Trival A-B Subvirion vaccine. This event was assessed as medically significant.  On an unknown date, the patient developed a non-serious event patient had localized reaction (vaccination site reaction) (unknown latency) following the administration of Influenza USP Trival A-B Subvirion vaccine.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (patient had localized reaction, brain swelling).  At time of reporting, the outcome was Unknown for the event patient had localized reaction and was Unknown for the event brain swelling.; Sender's Comments: Sanofi company comment dated 19-Apr-2023: This case involves a 9 months old female patient who experienced brain swelling and patient had localized reaction after receiving vaccine Influenza USP Trival A-B Subvirion Vaccine [Fluzone]. The clinical course of the event was not provided. Furthermore, information regarding condition at the time of vaccination, role of medical history, lab data excluding other predisposing etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Started with chest pain the evening of 6/11/21. Also reported  tachycardia the night of 6/11/21 with a heart rate of 120 BPM. Tachycardia resolved by the morning of 6/12/21 and chest pain resolved on 6/13/21.  Started with diarrhea, fever(101), and nausea 24 hours after receiving the vaccine and that lasted 2 days.   No treatments were done due to patient not being seen by doctor for side effects.
mom went to check on pt 330AM 8JAN95 & pt was not breathing-mom dialled 911-paramedics did not attempt CPR, they said pt had been dead a while;-pt was a twin brother; coroner's office state COD poss SIDS;
Swelling rt eye by 12OCT91 swollen shut; "water blisters" on eyebrow, forehead & scalp; 15OCT91 seen by MD @ ER dx probable flu reaction;
Irritation and swelling at injection site, swelling of entire left arm, irritability and stopped using left arm for several hours due to pain and would not play. After giving motrin and icing the arm the pain eventually went away, but the arm remained swollen for a few weeks and the injection site was still red and bruised.
Hands and forearms went numb. Numbness worsening closer to my hands and very numb from wrists to finger tips; This is a spontaneous report from a non-contactable nurse, the patient. A 42-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 09Aug2021 at 17:00 (at the age of 42-years-old) as a single dose for COVID-19 immunisation. Medical history included known allergies to pollen, cats and dust. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 10Aug2021 at 10:00, the patient's hands and forearms went numb, numbness was worsening closer to hands and very numb from wrists to finger tips. The event resulted in doctor or other healthcare professional office/clinic visit. Since the vaccination, the patient had not been tested for COVID-19. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event hands and forearms went numb, numbness was worsening closer to hands and very numb from wrists to finger tips was unknown at the time of this report.  No follow-up attempts are possible. No further information is expected.
Headache, Myalgia, Arthralgia, Fever, fatigue, chills Narrative:
Starting at 4:00 am on 11-14-21 Hives on head, arms, wrists, chest, stomach, back, and angioedema -severely swollen lower lip, swollen ears, swollen wrists, swollen eyes, swollen face.
Received Tdap in left upper arm. Received Influenza in right upper arm. Received PPSV23 in mid right arm.  Approx 7-8 hours after vaccinations, the site around the PPSV23 became very firm and warm to touch.  On night of October 5th, experienced unusual dreams, restless sensation and profuse sweating.  On morning of October 6th, I experienced intense flu-like symptoms (felt cold, but sweating, headache) and PPSV23 injection site appeared bruised (4-5cm in diameter) with raised bumps. By 8:00pm, I experienced body temperature of 101.2 F and became photophobic and nauseated.   On October 7th , rash around PPSV23 injection site was dark red- purple in color, with raised bumps and measured 7cm in diameter. However body temperature down to around 99.5 F but still felt clammy, with cold sweats and headache.  Upon waking on October 8th, experienced a headache but felt fine otherwise.  Raised circle around PPSV2 injection site dissipated over approx. two weeks and felt itchy at site for an additional week.
weakness; dizziness; headache; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), lot number not reported, via an unspecified route of administration from an unspecified date as SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was experiencing weakness, dizziness and headache after receiving her first dose of COVID-19 Vaccine. The outcome of the event was not recovered at the time of report.  Information on lot/batch number has been requested.
Arm sore, fatigue, difficulty sleeping the night of the vaccination.  Next morning, worsening of arm sore, chills, fatigue, nausea.  Fever over 102 lasted a day in half. Took Tynelol twice before it came down to 100 the next morning. Was totally fine again by 1/29, 3 days after vaccine.
chest pain; pain under arm pits; pain under arm pits, up neck, and down her arms; dizziness; pain is now in hands, elbows; pain is now in face; Pain in neck and throat; pain is now in upper pallet; different taste in her mouth; lips, tongue, and mouth numbness; tingling; shortness of breath; pain in her joints/elbows; This is a spontaneous report received from a contactable other HCP (Nurse, patient). This female patient of unspecified age reported that she received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration on 11Jan2021 as a single dose for COVID-19 vaccination. The Patient was completely healthy before this with no history. The concomitant medications included zoloft, steroids, tylenol and protonix. On 9Feb2021 she began having the following symptoms: chest pain, pain under arm pits, up neck, and down her arms. She had visited the physician several times and everything was normal. symptoms got worse with dizziness, pain is now in hands, elbows, face, upper pallet, neck and throat. It did not go away. She has a different taste in her mouth. She has lips, tongue, and mouth numbness and tingling that comes and goes. She has shortness of breath and pain in her joints. At one point she was admitted to the hospital for 6 days- all labs, scans, xrays, MRI's were normal. She would see a rheumatologist and getting out lab tests done. She said her Rheumatologist was treating another nurse that now has paralysis due to the vaccine. The patient receive treatment for the events. The outcomes of events are unknown.  Information on Batch number/Lot number can not be obtained.; Sender's Comments: Based on the information provided and plausible temporal association, the causality between the suspect drug and the events cannot be completely excluded.  This impact of this report on the benefit/risk profile of  the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Patient received the Pfizer booster on his right arm. He felt numbness and tingling on his arm immediately after vaccination. He returned to vaccination clinic at 3:20PM complaining of decreased strength in his right arm, numbness and tingling. He mentioned that the feeling was similar to when he pinched a nerve in his arm 20 years ago. His blood pressure was measured and was recorded at 149/92. He was advised by pharmacist to go to the emergency department if the symptoms worsen or do not subside.
Generalized vaccinia to small pox vaccine approx 3 wks after administration. Chicken pox on hands, elbows, feet, knees.
Tinnitus in both ears began 5 days after vaccine, went to PCP on 3/4/21 do a closed as ear infection prescribed amox-clav, but got worse and not better. Saw ENT on 3/12/21. And could not find any physical cause for tinnitus. Had hearing test, nothing.
Pain, redness, warm at injection site and Itching x 5 days. Tylenol helped to sleep at night.
Patient developed severe headache with nausea and vomiting.  Went to ER and they decided to keep her overnight for monitoring since she continued to have these symptoms.  She said it took about a week to get to full recovery.
pt recv vax & no problems noted until following day 24hr p/vax given became irritable, screamed for 5min;fell asleep & devel jerking during sleep;also did it asleep;pt seen in ped office & sent to neuro;
Local area of inflammation around injection site, approximately 3 1/2 inches long and 1 inch wide.  There was a darker red, swollen area within the inflamed area that was 2 1/2 inches long and 1 inch wide.  Reaction resolved without treatment by 11/25/15.  Pt reported reaction to me.
No other AE; Incorrect product storage; This spontaneous report was received from an office manager referring to unknown number patients of unknown age and gender. The patients' concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On unknown dates, the patients were vaccinated with improperly stored of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1637651, expiration date 09-JUN-2022; dose and route were not reported) for prophylaxis (product storage error).    The administered doses of the vaccines experienced a temperature excursion of above 47 Fahrenheit (F) (48.98 F) for 3 hours 30 minutes (also reported as 49 F). There was no previous temperature excursion. The digital data logger was involved. No other AE was reported. Device was not available for evaluation (obtain was false).  This case was non-valid due to no patient identifiers.  Follow-up information has been received from the office manager on 21-JAN-2021.  The patient was 11-year-old male. He was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) on 18-NOV-2020 at a private doctor's office/ hospital. The vaccine was purchased with public funds. There was a power outage and the temperature was out of range for 3.5 hours. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: 1637651; expirationdate: 09-JUN-2022; deviceage and unit: 0 ; malfunction: Unknown; productavailableforevaluation: No; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
The spontaneous report has been received from a physician via company representative and refers to a patient of unknown age and gender. Information on medical history was not reported. On an unknown date the patient received the full series of Hepatitis B Vaccine (Recombinant) vaccine (manufacturer unknown) (lot #, expiry date not reported) (dose number, dose, strength, route, frequency not reported), it was reported that hepatitis B vaccine (recombinant) (RECOMBIVAX HB) could not be rule out. Information on concomitant medication was not reported. On unspecified dates the patient underwent serological testing for immunology resulting in hepatitis B titers as negative and patient was then administered  another dose of Hepatitis B Vaccine (Recombinant) vaccine (manufacturer unknown) (lot # expiry date not reported) (dose number, dose, strength, route, frequency not reported) and again the titers were negative. The outcome of the adverse events was unknown. The reporter did not assess the relationship between the Hepatitis B Vaccine (Recombinant) vaccine (manufacturer unknown) and the adverse events. Additional information is not expected.
I was on my computer and I felt a burst in my left hand. My  left hand had swelled to the size of baseball bat and it hurt really bad. I called my doctor and couldn't get ahold of him and went to ER. From wrist to knuckles had turned completely black. They lowered my blood thinner - from two doses of Brilinta to one dose of the generic form of Epient. I had a follow up visit with cardiologist - he is the one that changed my medication. Note: I'm estimating the dates of the vaccines for COVID and my second dose of the Shingles vaccine - I had it Pharmacy-and it was three weeks after the first dose of the COVID vaccine; and three weeks before the 2nd dose of the vaccine.
Soreness in my arm like some flu shot; Pain; After she received the first dose she experienced an achy sore arm on the injection site.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 28 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11May2021 (Lot number: EW0182) at the age of 28 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ARIPIPRAZOLE taken for contraception. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Soreness in my arm like some flu shot"; PAIN (non-serious), outcome "unknown", described as "Pain"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "After she received the first dose she experienced an achy sore arm on the injection site.".  Additional information: second dose is scheduled on 01Jun2021. After she received the first dose she experienced an achy sore arm on the injection site. She was asking as well if it was okay to take medication or Tylenol.  No follow-up attempts are possible. No further information is expected.
Caller reports her husband had Covid last August; 1st one: 04Feb2021 2nd dose: 26Oct2021 Next one: 04Mar2022 Next one: 01Apr2022; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Caller reports her husband had Covid last August) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st one: 04Feb2021 2nd dose: 26Oct2021 Next one: 04Mar2022 Next one: 01Apr2022) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No medical history information were reported by the reporter.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st one: 04Feb2021 2nd dose: 26Oct2021 Next one: 04Mar2022 Next one: 01Apr2022). In August 2022, the patient experienced COVID-19 (Caller reports her husband had Covid last August). At the time of the report, COVID-19 (Caller reports her husband had Covid last August) had resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st one: 04Feb2021 2nd dose: 26Oct2021 Next one: 04Mar2022 Next one: 01Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication details not reported by the reporter. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that patient workouts for 2 hours in the morning and very healthy. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-733107, US-MODERNATX, INC.-MOD-2023-733118 (Linked Report). This case was linked to MOD-2023-733102 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733107:Same Reporter US-MODERNATX, INC.-MOD-2023-733118:Same Reporter
muscle pain; This is a spontaneous report from a contactable Consumer or other non-health care professional. Caller was reporting for her Husband. A male patient of an unspecified age received BNT162B2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch no/Lot number/Expiry date: Unknown) via unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Patient's medical history and concomitant medications were not reported. On an unknown date, patient experienced Muscle pain after first shot. Seriousness was reported as No. Outcome for the event was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected
This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (feel crummy) 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 23-May-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-May-2022, the patient experienced ILLNESS (feel crummy). At the time of the report, ILLNESS (feel crummy) outcome was unknown. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter. Reporter did not allow further contact
Patient received her second dose / powder was reconstituted with sterile water; Patient received her second dose / powder was reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 51-year-old female patient who received Herpes zoster (Shingrix) (batch number E9C7K, expiry date 14th October 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (1st dose received on 22nd December 2020).   On 25th May 2021, the patient received the 2nd dose of Shingrix. On 25th May 2021, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.  Additional details were reported as follows: The patient received 2nd dose of Shingrix but the powder was reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. No further events were reported at the time of the phone call. The reporter consented to follow up via an email.
Mother reported pt's eye (Right) started to become crossed within 24 hours of vaccine administration. Did not report to office until next well check 6 months later. Referred->oph. Dx. Strabismic Amblyopia of right eye (high hyperopia).
This case was reported by a nurse and described the occurrence of an injection site reaction in a 4 yr old female subject who was vaccinated with diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (Infanrix) for prophylaxis.  On 29Aug05 the subject received the 5th dose of Infanrix in the left arm (lot AC14A006BA). On 29Aug05 the subject was also vaccinated with measles, mumps and rubella virus vaccine (MMRII) and inactivated poliomyelitis virus vaccine (Ipol) at unspecified sites of administration. On 30Aug05, 1 day after vaccination with Infanrix, the subject experienced an injection site reaction characterized as redness, swelling, pain and warmth. The injection site reaction resolved on an unspecified date on or after 30Aug05 and on or before 06Sep05. The nurse considered the injection site reaction to probably be related to vaccination with Infanrix.
Muscle tightness/knot/cramping in calf, neck, abdominal. Unusual because in all my years of being active; this has never happen before. Needed physical therapy and are currently under chiropractic care to solve this issue.
Fever of about 104.9, hand where vaccine was adminstered was swollen the size of a golfball
vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F lowon 4Jan2022; Vaccine administered to 45 patients past 30-day use by date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F lowon 4Jan2022) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F lowon 4Jan2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to 45 patients past 30-day use by date) and PRODUCT STORAGE ERROR (vaccines were stored in a standard freezer but temperature 2 degrees F high -1 degrees F lowon 4Jan2022) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided.  Vaccine was initially stored in refrigerator on 4Jan2022 and beyond used date for the product was 2Apr2022.  No treatment drug information was provided. Case is reported for the sixth out of 45 patients who had received expired vaccine as reported by the reporter.
Horrendous head pain, feeling like my brain was being split apart, so intense I couldn?t walk, reoccurring each time after the vaccines. Went for an MRI with nothing unusual found. Mysteriously went away. Came down with Covid in February and pain started again 11 days after first symptoms appeared of Covid.