chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a nurse via sales rep and described the occurrence of allergic reaction in a 17-year-old female patient who received BEXSERO (batch number 157501, expiry date 31st August 2017. The patient's past medical history included attention deficit/hyperactivity disorder (experienced in July 2014). Concomitant products included amfetamine aspartate + amfetamine sulfate + dexamfetamine sulfate +dexotroamphetamine saccharate (ADDERALL) and ethinyloestradiol + levonorgestrel (SEASONIQUE). On 20th July 2016, the patient received the 1st dose of BEXSERO .5 ml. In July 2016, less than a week after receiving BEXSERO, the patient experienced injection site swelling. On 20th July 2016, the patient experienced allergic reaction, injection site lump, injection sit induration, injection site pain, injection site warmth. On an unknown date, the outcome of the allergic reaction, injection site warmth and injection site swelling were unknown and the outcome of the injection site lump and injection site duration were not recovered/not resolved and the outcome of the injection site pain was recovering/resolving. The reporter considered the allergic reaction, injection site lump, injection site induration, injection site pain, injection site warmth and injection site swelling to be related to BEXSERO. Additional details were provided as follows: This case was not previously reported to anyone. The patient experienced an allergic reaction at the injection site (left deltoid) including a hard knot that was painful and sore, hot to touch and looked similar to a shoulder pad. In the night, several hours after the vaccination, the patient started to feel pain then the swelling started. At the time of reporting, pain was not as bad but hard knot was still huge.
Patient called on 03/16/2023 at 9:15am stating that she is experiencing redness, swelling after injection on 03/13/23 but warmness and itching the site of injection today 03/16/2023. Asked patient to put on ice pack and contact her doctor, patient informed me that she left a message for her primary care doctor already.
5-10 minutes post injection, pt reported "I don't feel well"  States feels hot/nauseous/weak.  Assisted to chair.  Had brief (15-20 second) episode of stiffening, apnea, dusky coloring, arched back with stiff extremeties and shaking and loss of consciousness.  Spontaneous respirationss returned when stiffness/arching ended, with slow return of pale/pink skin coloring.  Able to converse.  Remained dizzy, diaphoretic.  During event pulse thread and fast.  BP 84/42 post return of consciousness.  911 called.  Patient transferred via EMS to ER.
pt recvd vax 2OCT92 & exp dizziness & was feeling unbalanced; sx resolved p/3 days; No further details were provided;
Sore muscles; Injection site pain; This is a spontaneous report from a non-contactable consumer, the patient. A 31-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 11:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included allergy to nuts and COVID-19. Prior to the vaccination, the patient was diagnosed with COVID-19. Concomitant medications included ascorbic acid (VITAMIN C), zinc (MANUFACTURER UNKNOWN) and sitosterol (CHOLEST-OFF); all from unknown date for unknown indication and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 09Apr2021 the patient experienced sore muscles and injection site pain. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events sore muscles and injection site pain were not resolved at this time of report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Needle puncture site remained purple - no associated edema, no erythema, no pain. On 9/17/2018, solid white substance was expressed from the injection site. Area around the puncture site remains purple. Injection site appears to have formed a granuloma.
Initial unsolicited report received from the literature on 14 September 2015. This case is linked to 2015SA146032, 2015SA146043, 2015SA146044, 2015SA146045, 2015SA146046, 2015SA146047, 2015SA146048, 2015SA146049, 2015SA146050, 2015SA146051, 2015SA146052, 2015SA146053, 2015SA146054, 2015SA146055, 2015SA146056, 2015SA146057, 2015SA146058, 2015SA146059, 2015SA146060, 2015SA146061, 2015SA146062, 2015SA146063, 2015SA146064, 2015SA146065 and 2015SA146067 (Same literature). The following is verbatim from the article: Background. Reporting of adverse events (AEs) following vaccination can help identify rare or unexpected complications of immunizations and aid in characterizing potential vaccine safety signals. We developed an open-source, generalizable clinical decision support system called Electronic Support for Public Health-Vaccine Adverse Event Reporting System (ESP-VAERS) to assist clinicians with AE detection and reporting. Methods. ESP-VAERS monitors patients' electronic health records for new diagnoses, changes in laboratory values and new allergies following vaccinations. When suggestive events are found, ESP-VAERS sends the patient's clinician a secure electronic message with an invitation to affirm or refute the message, add comments, and submit an automated, prepopulated electronic report to VAERS. High-probability AEs are reported automatically if the clinician does not respond. We implemented ESP-VAERS in December 2012 throughout an integrated healthcare system. We queried the VAERS database to determine the healthcare system's baseline reporting rates from January 2009 to March 2012 and then assessed changes in reporting rates with ESP-VAERS. Results. In the 8 months following implementation, 91 622 vaccinations were given. ESP-VAERS sent 1385 messages to responsible clinicians describing potential AEs. Clinicians opened 1304 (94.2 percent) messages, responded to 209 (15.1 percent), and confirmed 16 for transmission to VAERS. An additional 16 high-probability AEs were sent automatically. Reported events included seizure, pleural effusion, and lymphocytopenia. The odds of a VAERS report submission during the implementation period were 30.2 (95 percent confidence interval, 9.52-95.5) times greater than the odds during the comparable preimplementation period. Conclusions. An open-source, electronic health record-based clinical decision support system can increase AE detection and reporting rates in VAERS. This case involves a patient (age and gender not reported), who was vaccinated with a dose of HIB (Manufacturer: unknown), a dose of DTAP-HEPATITIS B-IPV (Manufacturer: other), a dose of PCV13 (Manufacturer: other) and a dose of Rotavirus (Manufacturer: other) (batch number, route, dose in series and site of administration were not reported) on unspecified date. Medical history and concomitant medications were not reported. On unspecified date following the vaccination, the patient experienced fever. Lab tests and corrective treatments were not reported. Outcome of event was not reported. Documents held by sender: none. Follow-up information received from physicianon 19 October 2015. No additional information provided.
I was very tired, extremely cold, I had a fever, small cough, drainage, and congested, my throat hurt a little, I had a headache.  I went to the clinic so they could test me for both COVID-19 and Influenza A and B. They used a rapid PCR COVID-19 test that came back positive and tested me for Influenza A and B that came back negative. I was prescribed the Paxlovid, halfway through the dose pack I started to feel better, the taste was horrible. I did get rebound COVID. It took a total of three weeks before I finally tested negative.
Shortly after receiving the vaccine, my mother started to suffer from  numbness/ loss of feeling  in what started in her arms then quickly spread to her legs and feet. She was later diagnosed with neuropathy   She found a neurologist in December of 2021 that was willing to her help her but sadly she died on January 18th 2022
body stiff, eye rolled up, grunting, noises, urinated on self, lasting approx 1min;
Patient developed febrile seizure and vomiting. He was taken to the ER and given IV fluids. A UA and CT of head were performed. He was started on antibiotics.
patient received the first dose of Twinrix on 12Jun2023, and the second dose today on 10Nov2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old male patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix (could have received the 1st dose of Twinrix in May 2023).   On 10-NOV-2023, the patient received the 2nd dose of Twinrix. On 10-NOV-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: patient received the first dose of Twinrix on 12Jun2023, and the second dose today on 10Nov2023.). The outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 10-NOV-2023 The pharmacist reported that the patient had received 2 doses of Twinrix. At the end of the call pharmacist stated that it was possible that the patient started the series in his physician's office and could have received the first dose in May 2023. The patient received second dose of Twinrix later than the recommended interval, which led to drug dose administration too long. The reporter consented to follow up.
a lot of rash on his back and shoulder; hives on his back and shoulders; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 38 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 12Jul2021 14:00 (Batch/Lot number: unknown) at the age of 38 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Type 2 diabetes" (ongoing), notes: diagnosed 3 years ago. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Anatomical location: Arm left), administration date: 02Jun2021, when the patient was 38 years old, for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset 13Jul2021, outcome "not recovered", described as "a lot of rash on his back and shoulder"; URTICARIA (non-serious) with onset 13Jul2021, outcome "not recovered", described as "hives on his back and shoulders".  Additional information: Reporter stated that about a month and a half ago she and her family received the Pfizer Covid-19 vaccine, the day after receiving the second dose of the vaccine, her husband began to experience an allergy in the back and shoulders, he had many hives. Reporter stated that this reaction did not present with the first dose and the other members of her family did not have this reaction either. Reporter stated that patient had (not every day) a lot of rashes on his back and big hives on his back and shoulders. The next day after the second dose of the vaccine, he had an allergic reaction. Reporter stated that patient was still experiencing this reaction. Reporter stated that patient had rash and hives showed up the next day after the second dose and had been putting rubbing alcohol on his hives and rash, and they went away. But they keep going away and coming back. It is not constant. They keep coming and going.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
facial tic/tics have slowed down to once a minute; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL SPASM (facial tic/tics have slowed down to once a minute) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history provided.     On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FACIAL SPASM (facial tic/tics have slowed down to once a minute). At the time of the report, FACIAL SPASM (facial tic/tics have slowed down to once a minute) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication provided. No concomitant medication provided.
This spontaneous report has been received from a healthcare worker concerning unspecified number of patients of unknown age and gender. Patients concomitant medication, pertinent medical history and drug reactions/allergies were not reported. On unknown dates the patients were vaccinated with doses of improperly stored RECOMBIVAX HB (strength, unit, frequency and route not reported, lot # L038018 with Exp. date 13-SEP-2017 and lot # L027733 with Exp. date 13-SEP-2017. Temperature that the vaccine exposed to was 34.81 F to 34.84 F with time frame 32 hours (non-consecutive). No adverse effects were reported. This is one of several reports received from the same reporter. Additional information is not expected because of no consent to contact the physician.
The patient experience tightness of her chest. She was hook up to be monitored. Her BP was 185/91. Her heart rate was 122. Her O2 level was 100. The nusre notice swelling at the area of the site with mild erythema (redness).
Immediately after removing the injection from auto-retract method pt's arm began to bleed and a bump formed. I must have hit a blood vessel. I encouraged pt to apply cool compresses and take TYLENOL for discomfort if any and call us w/any problems.
No adverse event noted; The vial that this dose was withdrawn from was diluted with Sodium Chloride 23% instead of 0.9%. Contacted Pfizer and they stated that no info was available regarding this scenario and referred me to recommendation of revaccinating this individual.
B Cell Lymphoma; Foam in her lungs; brain injury; pain; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non healthcare professional) from medical information team for a Pfizer sponsored program.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHOMA (medically significant), outcome "unknown", described as "B Cell Lymphoma"; PULMONARY OEDEMA (medically significant), outcome "unknown", described as "Foam in her lungs"; BRAIN INJURY (medically significant), outcome "unknown", described as "brain injury"; PAIN (non-serious), outcome "unknown", described as "pain". The patient underwent the following laboratory tests and procedures: investigation: negative. Therapeutic measures were not taken as a result of lymphoma, pulmonary oedema, brain injury, pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Day 0: hot left arm, blood to surface of skin on inner arm, two inches below injection site, size of dime (resolved Day 3); Day 0: Pain at injection site (resolved Day 3); Diarrhea (resolved Day 3); Fatigue (resolved Day 12); Dizzy (resolved 90% by Day 29).  Day 1: Insomnia (resolved Day 17), nerve pain on left eye, ear, leg, and foot, and headache (resolved Day 6); Tinnitus (not resolved); hypervigilance, feel like I am speeding, high anxiety during normal routines (resolved Day 17)  Day 8: Brain fog, unable to concentrate, immediate memory impaired, feel like I am getting dimentia (like covd patients say (resolved 80% by day 29)
Arm went dead for 5 minutes. Could have cut it off and I wouldn't have known. The sensation came back shortly, but I was very scared during that time.; This spontaneous case was reported by a patient and describes the occurrence of HYPOAESTHESIA (Arm went dead for 5 minutes. Could have cut it off and I wouldn't have known. The sensation came back shortly, but I was very scared during that time.) in a male patient of an unknown age 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.    In October 2022, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Arm went dead for 5 minutes. Could have cut it off and I wouldn't have known. The sensation came back shortly, but I was very scared during that time.). At the time of the report, HYPOAESTHESIA (Arm went dead for 5 minutes. Could have cut it off and I wouldn't have known. The sensation came back shortly, but I was very scared during that time.) had resolved.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was reported that patient had the 2 original Moderna shots and 3 boosters. He had the bivalent last October. He was about to take the new one. Patient knew that the bivalent vaccine was different. He was eft handed, so took shot in right arm. His arm went dead for 5 minutes and could had cut it off and wouldn't have known. The sensation came back shortly, but he was very scared during that time.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-020830, US-MODERNATX, INC.-MOD-2021-362014 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-020830:Dose 1 US-MODERNATX, INC.-MOD-2021-362014:Dose 2
Consent form completed stating client had not received any COVID vaccines. 1st Moderna dose was administered. When entering the vaccine information in, it was discovered that the client had already received two doses of Pfizer, 1st dose on January 2, 2021 and 2nd dose on January 23,  2021. At this time no adverse reactions have been reported. The nursing home that the resident lives at was immediately notified.
No significant reaction to first dose.  On receipt of second dose, localized pain felt.  Within 24 hours, patient noted an increase in pre-existing anxiety disorder, significant insomnia, longer than normal sleep once sleep was achieved, and other psychological effects including worry, fight-or flight tendencies, and impulsiveness.  Lorazepam administration was doubled in frequency and quadrupled in dosage from pre-vaccination levels.  Medical log available for review if needed.  At no point have anxiety symptoms resulted in either suicidal ideation nor any actual attempts.  Social and physical environment have not changed.  News and social media have been turned off by patient's own actions.
Balance problems; ringing in my ears; This spontaneous case was reported by a consumer and describes the occurrence of BALANCE DISORDER (Balance problems) and TINNITUS (ringing in my ears) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019821A and 032M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BALANCE DISORDER (Balance problems) and TINNITUS (ringing in my ears). At the time of the report, BALANCE DISORDER (Balance problems) and TINNITUS (ringing in my ears) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.
Pt reported that he had a seizure at night on the same day he received the Fluzone HD vaccination. He reported that he went to the ER but that he is okay now. He has had this same vaccination multiple times in past with no reaction.
Runny nose started next day also felt out of sorts and gravly next day. 3 days after shot started having chest pain, pain in back and achy all over, denies cough.
11-20-07 One day after IM Tdap given - pt states last p.m. had episode of tingling around mouth and feeling of tightness arm and mouth - felt like lips swelled - observers said no. Face/head became very hot. She took 2 Benadryl and recovered. Now has red, hot, swollen knot at 50 cent piece size on (L) deltoid.
Arm swelled up; Lymph nodes swelled up; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelled up) and LYMPHADENOPATHY (Lymph nodes swelled up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced PERIPHERAL SWELLING (Arm swelled up) and LYMPHADENOPATHY (Lymph nodes swelled up). At the time of the report, PERIPHERAL SWELLING (Arm swelled up) had resolved and LYMPHADENOPATHY (Lymph nodes swelled up) had not resolved.            Patient arm swelled up- 3 days later his lymph nodes swelled up and up. Patient arm swelling went away but lymph nodes are still swollen. Patient declined to share any other information.  No concomitant medications were provided. No treatment medications were provided   Reporter did not allow further contact
Vomiting x 6; nausea; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the arm left on 05May2021 at 14:15 (at the age of 24-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient was allergic to crab. The patient received unknown birth control within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05May2021 at 02:15 (as mentioned in the source document), the patient experienced vomiting and nausea. The adverse events did not result in doctor or other healthcare professional office or clinic visit and emergency room or department or urgent care. It was unknown if the patient received any treatment for adverse event. The clinical outcomes of the events vomiting and nausea was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
pt called from out of town c/o itchy rash, very sore, swollen neck glands, very sore throat, malaise;
Received PNEUMOVAX Rt deltoid 10-26-10. Awoke 10-27-10 with crescent shaped blister, yellowish drainage, slight tenderness at site, temp 99 degrees, dizziness; chills/sweats, nausea; no wheezing or SOB advised BENADRYL Q6hrs, call prn.
It started on 3Jan2022 with sinus headache, the next morning chills and sore throat and nasal congestion. Started coughing. I took a home text and it was negative on 5 Jan2022 and then went to get PCR and got positive. I was fatigued for 2 to 3 weeks. Had to take my nebulizer helped with congestion and wheezing.