chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Pt reported to the Medical Group approximately 45-60 minutes after receiving the influenza vaccine. Pt reported that his left arm "is asleep" where he received the injection. Bilateral palms of hand had mottled appearance. Redness and flushing of the skin noted on bilateral arms and neck. Patient also reported having a "scratchy" throat but attributed it to quitting smoking three weeks ago. 25mg Benadryl PO was administered at 1510. Pt denies having any chest tightness, SOB, difficulty breathing, inability to swallow own saliva, and other severe adverse reaction signs. Capillary refill <2 seconds. Vital signs stable. Pt was kept for observation until 1550. Mottling of the palms resolved. Flushing of the skin resolved as well. Pt was directed to see his primary care provider tomorrow morning to report symptoms and to also receive evaluation for the left arm numbness and tingling.
7 days after severe tinnitus in right ear. Very high pitched tone; This is a spontaneous report from contactable consumer, the patient. This 49-year-old male patient reported that he received his first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/lot number: ER8727) via an unspecified route in the left arm in Mar2021 at 11:00 (at the age of 49-years-old) as a single dose for COVID-19 immunization. Medical history was not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included phenytoin (DILANTIN) and atorvastatin. The patient reported that 7 days after, on 27Mar2021, he experienced severe tinnitus in the right ear. He described it as a very high pitched tone occurring constantly 24 hours a day and still there today. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Treatment was received for the adverse event which included prednisone and a hearing aid. The outcome of the event was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
I received my Covid-19 vaccine on 09/09/2022. On 09/10/2022 I woke up around 01:00AM with a headache and sore arm. The next day I began having loose stool. On 09/12/2022 I started having diarrhea that lasted for the next 5 days. On 09/17/2022 I saw the doctor and was prescribed ZOFRAN and LOMOTIL as well put on a strict diet called BRAT. The diarrhea stopped after taking medication that same day. Have not had symptoms since.
Patient states she "blacked out" approx. 25 mins after vaccines given. She was sitting, regained consciousness on her own. Pt feels weak and shaky after.
Developed rash on arm near injection site that spread to face. Rash consisted of urticaria and VARIVAX like vesicles.
Sore left shoulder, tingling/numbness in left fingers, rash at injection site developed over several days.
2.5 inch lump on left arm and 0.5 inches tall, toward the inside of the upper arm (not exactly at the injection site, higher up). Lump is hard, not red or warm or itchy or painful. Started 5/16 in the evening.
t105 fever x 2 days; rash over body, spotty face; no other rxn to shots;
Pt recvd DTP/HIB 23JAN92 & was fussy that noc 2 hrs crying spell & following AM felt very hot & had brief limp, unrresponsive spell w/tremor; irritable but otherwise nl in office; slept quite a bit rest of day; parent felt febrile seizure;
Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2014, the patient was inoculated with the ZOSTAVAX vaccine as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. In 2015, the patient was treated at a medical center for a persistent and severe vesicular rash, which was diagnosed as herpes zoster or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Initially patient was quite irritable and slept a lot, maybe for the first three days.  The worst symptoms I suspect come from the rotateq vaccine, since it works by creating a "mild" intestinal infection.  Patient has had horrible intestinal cramping that keeps us both up all night, and keeps patient from sleeping during the day as well; it also seems to interfere with his eating.  I can actually hear his intestines gurgling loudly since he received the vaccine.  The pain and gurgling then result in voluminous, forceful, watery diarrhea at least once a day.
WOKE UP WITH SWOLLEN UPPER ARM, RED, HOT TO TOUCH, RASHY.
This case was reported by a nurse and described the occurrence of extensive swelling of vaccinated limb in an unspecified number of patients who received MENVEO. Co-suspect products included BEXSERO. On an unknown date, the patients received MENVEO and BEXSERO at an unknown dose. On an unknown date, an unknown time after receiving MENVEO and BEXSERO, the patients experienced extensive swelling of vaccinated limb, injection site induration, injection site redness and injection site warmth. On an unknown date, the outcome of the extensive swelling of vaccinated limb, injection site induration, injection site redness and injection site warmth were unknown. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site induration, injection site redness and injection site warmth to be related to MENVEO and BEXSERO. Additional details were provided as follows: In the morning of reporting date, the sales representative called the office nurse and at this visit they discussed that there were a high number of patients with severe local reactions to the MENVEO and BEXSERO vaccines. These patients were returning to reporter's office with very large, reddened, swollen, hardened, warm induration at the injection site and the surrounding area, many times measuring 6 inches or more from the injection site. the physician had prescribed oral antibiotics for most of these patients. the reporter had tried several different methods of mixing the vaccine (letting it sit, administering it immediately, etc), but none had proved effective in reducing reaction rates. the reporter requested for suggestions on how they could possibly reduce the potential for a local reactions. Also, they inquired if there had been any problems with certain lot numbers of the vaccine, so that they could compare those numbers to the vaccines which they administered to their parents. This case has been linked to 5 other cases (MENVEO vaccine), reported by the same reporter.
C/O swelling, redness, tenderness, pain in R delt. Parent reports no fever, no NVD, no decrease in appet and states, "she is normal except her sore shoulder." Client examined by RN. All axillary, submandibular and submental lymph nodes nonpalpable. Client reports pain to touch.  Advised cool pack and Tylenol per manufacturers direction and to seek immediate tx at Hospital is S/S worsen. All questions answered.
Patient felt she had rapid heart rate after vaccination. Patient moved to exam room. 11:45 HR 74, BP 132-55. 11:50 HR 65, BP 120-72. Vital signs within normal limits. Left at noon.
Drug ineffective; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71-year-old female patient received BNT162b2 (BNT162B2 NOS), on 01Sep2022 at 12:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: COVID-19 (medically significant) with onset 2023, outcome "unknown", described as "COVID 19 Treatment"; DRUG INEFFECTIVE (medically significant) with onset 2023, outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical Course: The patient had no known allergies. Patient received Paxlovid as treatment of COVID-19 from 05Mar2023 to 09Mar2023. Patient also received Acetaminophen from 05Mar2023 to 07Mar2023.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300116551 Same patient, different product and event;
Employee presented to employee health office around 1:50pm after receiving vaccine approx 12:30pm today. Employee was pale, diaphoretic, c/o being lightheaded, dizzy, heavy breathing, and fatigued. Employee called PCP but then decided to go to the ER.
Mother could not remember start of symptoms, pruritic rash. Client and mother came to clinic 9/15/15, was referred to urgent care. Went to urgent care 9/15/15 and started on prednisone 20mg pack x 7 days and hydroxyzine 25mg 1 tab daily. On 9/17/15, mother reported improvement from rash.
Red spot where he received the injection; mild soreness; This spontaneous case was reported by an other and describes the occurrence of INJECTION SITE ERYTHEMA (Red spot where he received the injection) and INJECTION SITE PAIN (mild soreness) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (Red spot where he received the injection) and INJECTION SITE PAIN (mild soreness). At the time of the report, INJECTION SITE ERYTHEMA (Red spot where he received the injection) and INJECTION SITE PAIN (mild soreness) outcome was unknown.
Abdominal pain, diarrhea and fever starting 48 hours after injection. Lasted 4 days. Required treatment with antibiotics.
Pt has swelling,pain and redness on upper right arm. Redness and swelling extend from shoulder to elbow area, extended entire circumference of the arm. Pt was evaluated by provider and was started on antibiotics.
patient received a dose of ADACEL that was later found to have been expired with no adverse event; pregnant, at 28 weeks gestation with no reported adverse event; Initial information was received on 22-Apr-2022 regarding an unsolicited valid  non-serious case received from other health professional.  This case involves a 34years old female patient who was exposed to vaccine Diphtheria-2/Tetanus/5 AC Pertussis Vaccine [Adacel] in context of patient received a dose of Adacel that was later found to have been expired with no adverse event and pregnant, at 28 weeks gestation with no reported adverse event.   Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported patient received a dose of ADACEL that was later found to have been expired with no adverse event, pregnant and at 28 weeks gestation with no reported adverse event occurred at 28 weeks of pregnancy.  The date of last menstrual period, estimated due date were not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had unknown previous pregnancy/ies.  Concomitant medications included COVID-19 Vaccine (COVID-19 Vaccine) for Immunisation.  On 21-Apr-2022, the patient received 0.5 ml dose of suspect Diphtheria-2/Tetanus/5 AC Pertussis Vaccine (batch/lot number: U6539AA) via intramuscular route in the left deltoid (strength, formulation, expiration date: unknown) for immunization.   On 21-Apr-2022, the patient received a dose of adacel that was later found to have been expired with no adverse event (expired product administered) and pregnant, at 28 weeks gestation with no reported adverse event (exposure during pregnancy) (latency: same day) following the administration of Diphtheria-2/Tetanus/5 AC Pertussis Vaccine.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events (expired product administered and exposure during pregnancy).  Additionally, at time of reporting, the outcome of the pregnancy is unknown.   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.
Acute saddle pulmonary embolism. S/p pulmonary embolectomy. Spent 3 days in ICU + 2 days recovering at the Hospital
Joint swelling (right knee) with pain, a week after flu shot which was on Oct.21. Now, 3 weeks later, knee is fairly pain-free unless in use, but left shoulder (site of shot) quite painful and lifting left arm over head is difficult.  As I have many allergies, I believe most of the symptoms will disappear within 5 weeks, as other reactions have in the past. At least, I hope they disappear!
Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: numbess and tingling in legs difficult to move, went away in AM
Soreness in the left arm for a few days. Then developed hives and swollen lips a few days after the shot. I?ve been having hives all over my body, swollen eye lids and lips everyday since 1/07/2022. I?ve been taking over the counter allergy medicine everyday at least twice a day. It?s affecting my ability to function 100% in graduate school. My pcp gave me prednisolone(steroid pills) I took for 10 days but didn?t help.
Narrative:  A 61yo male who presented to the ER on January 31. 2022, with complains of eye irritation (swollen, stinging and tearing RT eye) x 3 days. Physician's post assessment /examination diagnosis was right eye corneal abrasion. The patient was discharged with naproxen, ofloxacin ophthalmic drop and e-mycin ophthalmic ointment for night time use and with discharge instruction. The ER nurse reported the patient had a historical ADR of influenza vaccine induced anaphylaxis updating his allergy information. No other detailed information regarding the influenza vaccine was provided. i.e. who administered the vaccine, when and where received, mfg, lot#, severity of reaction etc. Unable to find patient's medication history on profile.
Soreness at injection site; Bacterial infection; Throat infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 22 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03May2021 17:00 (Lot number: EW0173) at the age of 21 years as dose 2, single and intramuscular, administered in arm left, administration date 12Apr2021 17:00 (Lot number: EW0158) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Appendectomy", start date: 2004 (unspecified if ongoing), notes: other medical history: Appendectomy in 2004. Oral herpes., Seasonal allergies.; "Oral Herpes" (unspecified if ongoing), notes: other medical history: Appendectomy in 2004. Oral herpes., Seasonal allergies.; "Seasonal allergies" (unspecified if ongoing), notes: other medical history: Appendectomy in 2004. Oral herpes., Seasonal allergies.; "Appendicitis", start date: 01Sep2004, stop date: 01Sep2004, notes: Appendectomy performed same day due to rupture of appendix; "COVID-19 infection", start date: 14Jan2021, stop date: 25Jan2021, notes: Symptoms began on onset date, test confirmed on 16Jan2021. Concomitant medication(s) included: MG [MAGNESIUM] taken for supplementation therapy, start date: 13Nov2021 (ongoing); ZINC taken for supplementation therapy, start date: 13Nov2021 (ongoing); ASHWAGANDHA ROOT taken for disturbance in attention, start date: 13Nov2021 (ongoing); VITAFUSION VITAMIN C taken for supplementation therapy, start date: 13Nov2021 (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Soreness at injection site"; BACTERIAL INFECTION (non-serious) with onset 21Oct2021, outcome "recovered" (28Oct2021), described as "Bacterial infection"; PHARYNGITIS (non-serious) with onset 21Oct2021, outcome "recovered" (28Oct2021), described as "Throat infection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of bacterial infection, pharyngitis.  Follow-up (22Dec2021): Follow-up attempts are completed. No further information is expected.  Follow-up (04Jan2022): This is a spontaneous follow-up report received from the same contactable Other-HCP.
L arm- raised red mark around injection site. Warm to the touch. Area was itchy for pt. Seen by Dr. in office on 10/24/08. Benedryl 12mg every 6hrs as needed.
I started with a tingling in my left arm, which lasted about a month and then turned into severe pain. Later the pain disappeared but moved to the left arm, after about 2 weeks the pain in the arm stopped but moved to the upper back where it lasted about 3 weeks and after which the pain returned to the arms. At that time, my left buttock began to hurt simultaneously, then it spread to the thigh of my left leg. I have received physiotherapy, treatment only with heat because with the cold the pain became more intense. I have received massages, rubs with ointments and done exercises guided by the Physiotherapist. None of that worked and I stopped after about a month because the manipulation aggravated the pain. I went to a pain management doctor, who had to inject the painful area on my left buttock. Only the injection has relieved the pain in the left buttock a lot, but it still does not go away completely, still being of moderate intensity only in the presence of certain movements. Today, 10 months after these symptoms began, the pain has been decreasing. I no longer have pain in my upper back, but there is still a slight pain in both arms. The pain in the left buttock still persists, it is not permanent but it is moderate with many movements (such as lifting the leg for example to climb stairs). I have also noticed a tendency to cramp my arms, hands and legs with an ease and frequency that I did not have before.
Pfizer-BioNTech COVID-19 Vaccine   Approximately 9-10 hours after receiving the vaccination: Woke up in bed after about 3 hours of sleep hyperventilating (was not able to slow down breathing or shorten breaths) with tachycardia and a powerful bounding pulse. Extreme joint stiffness and soreness alongside body aches and painful headache. Was not able to return to sleep but breathing returned to normal and heart rate mostly steadied by morning. Was very dizzy and disoriented in the morning.
having a lot of itching since getting the Booster; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (having a lot of itching since getting the Booster) 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 an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (having a lot of itching since getting the Booster). At the time of the report, VACCINATION SITE PRURITUS (having a lot of itching since getting the Booster) outcome was unknown.            Concomitant medication was not reported. Treatment information was not reported.
Client complained of nausea and vomiting x 2 episodes after vaccination, vitals stable, symptoms resolved after 30 min observation period and client reports return to baseline
patient stated she had chest pain while in observation area, patient was alert and oriented, patient stated that she was nervous, emergency services were called and patient was taken to ED
Fever, T 101.9, called nurse 1 day after vaccination.  Then 2 days later hard nodule formed and grew.  Mom called nurse again 19 days after vaccination because nodule had become warm and slightly red. Pt was seen by physician 20days after vaccination and a nontender, erythematous nodule was noted in the left thigh. Pt was then seen again about 54 days after vaccination with acutely increased redness to vaccine site, swelling, tenderness, and oozing. Pt was treated with antitbiotics at that point.
Patient reported itching after injection. Her arm was sore later that evening. Her arm started to swell and turned red that evening. The red area surrounding the injection site increased in size over a 24 hour period. She developed a bruise from injection. She went to doctor and was prescribed KEFLEX 500 mg twice daily for 1 week. Her arm remains sore 1 week after administration.
Warm to touch; Hives reaction similar to the reaction from a bee stung; Red line which is swelled on the site of injection; Like an egg; itchy; injection site turn red / A line and the area turned a little pink; Tingly; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingly), VACCINATION SITE WARMTH (Warm to touch), INJECTION SITE MASS (Like an egg), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE URTICARIA (Hives reaction similar to the reaction from a bee stung) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE for Hypothyroidism.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced PARAESTHESIA (Tingly) and VACCINATION SITE ERYTHEMA (injection site turn red / A line and the area turned a little pink ). On 12-Mar-2021, the patient experienced INJECTION SITE MASS (Like an egg) and VACCINATION SITE PRURITUS (itchy). On 17-Mar-2021, the patient experienced VACCINATION SITE WARMTH (Warm to touch), VACCINATION SITE URTICARIA (Hives reaction similar to the reaction from a bee stung) and VACCINATION SITE SWELLING (Red line which is swelled on the site of injection). At the time of the report, PARAESTHESIA (Tingly), VACCINATION SITE WARMTH (Warm to touch), INJECTION SITE MASS (Like an egg), VACCINATION SITE PRURITUS (itchy), VACCINATION SITE URTICARIA (Hives reaction similar to the reaction from a bee stung), VACCINATION SITE ERYTHEMA (injection site turn red / A line and the area turned a little pink ) and VACCINATION SITE SWELLING (Red line which is swelled on the site of injection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment was reported for the events.