chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This case was reported by a healthcare professional and described the occurrence of injection site tenderness in a 53-year-old male subject who was vaccinated with TWINRIX (GlaxoSmithKline), TYPHIM VI. There were no concurrent medications. On 3 June 2008, the subject received unspecified dose of Typhoid vaccine in the right deltoid. At an unspecified time after vaccination with typhoid vaccine, the subject developed some injection site tenderness. The outcome of the event was not reported. On 4 June 2008, at 13:15, the subject received 1st dose of TWINRIX at 1.0 ml in the left arm. On 4 June 2008, approximately 2 hours after vaccination with TWINRIX, the subject developed a low grade fever and later that evening, mild injection site tenderness. At the time of reporting, the events were improved. In the reporter's opinion, the event of injection site tenderness was probably related to treatment with TWINRIX. The relationship of the fever to TWINRIX was not known. Follow-up information received on 08 July 2008, indicated that the onset of low grade fever and injection site tenderness began on 05 June 2008, 1 day following administration of TWINRIX. All of the events were resolved by 12 June 2008. The events were related to treatment with suspect vaccines, Typhoid and TWINRIX. It was noted that TWINRIX had been administered intramuscularly and the 2nd dose had not been given yet.
Patient with history of stroke, diabetes, and CAD.  She was brought to the ED by EMS from her nursing home on 11/7 with fever, productive cough, body aches, and weakness for the past day and a half. She tested positive for COVID-19 by PCR in the ED. Ultimately, she was admitted to the hospital 11/7 - 11/9. Discharge diagnosis included sepsis secondary to complicated ESBL E. coli cystits versus COVID-19 infection. During admission, she did not require steroids or any therapeutic interventions for COVID-19 infection other than supportive care. Patient has received the COVID-19 primary vaccine series and two boosters.
prolonged high-pitched crying x 4-6 hrs beginning aprox 3 hrs p/inject unable to console;
While nurse was injecting vaccine into pt arm, the needle separated from the syringe causing the vaccine to spray all over arm.  Estimating less than 50% of vaccine was injected into pt.1st  Pt was administered another does of 0.5 ml immediately with pt consent.
arm vaccine was injected into hurting really bad; itching in arm, chest, and back; This is a spontaneous report from a contactable consumer (patient herself). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) via an unspecified route of administration on 12Mar2021 (Batch/Lot number was not reported) as Dose1, Single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date in 2021, the patient had experienced bad itching. She added that on arm vaccine was injected into was hurting really bad for a few days and had itching in arm, chest, and back. She wanted to know what this itching could be and then it dawned on her that when talking to somebody else who had adverse reaction to a different shot that this could be a reaction to this shot. She added that she lives alone, and nobody had been in her house in a year, and she only goes to her mothers. She stated it had to be a reaction to the shot. She enquired whether she could take Benadryl or if she should visit her physician. She was a retired principal and had been secluded in her home for a year. She added that this was not bed lice and not scabies and that she had not been to a hotel. Patient stated that itching started on her back. Her arm hurt really bad, and it was in pain. After 3 or 4 days then her arm stopped hurting and the itching began. Itching was not as prominent on her arm as it was on her chest. She queried if anybody had experienced the same side effect. At the time of this report, the outcome of event arm vaccine was injected into hurting really bad was recovered on an unknown date in 2021 and itching in arm, chest, and back was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
extreme fatigue,  ringing in the ears,  mouth ulcers,  stomach pain,   chronic prolonged headaches,  vertigo, nausea, loss appetite, change in menstrual cycle, drop in blood placets, unable to resume normal life
A report was received from a health professional on 29 November 2001 regarding a 76 year old female patient who experienced systemic rash on 28 November 2001 after receiving fluvirin vaccine on 27 November 2001.  On 28 November 2001, the patient developed a rash approximately 24 hours after vaccination.  It was raised, pruritic and located on the trunk, scalp and face.  The patient was treated with Atarax.  The patient had a history of coronary artery disease, hypertension, osteoporosis and hyperlipidemia.  At the, time of reporting the patient had recovered.   The reporter has assessed the relationship of the study medication to the event as probable.
Patient, 65 year old male, PMH TBI/SC injury to C7, Tracheostomy dependent quadriplegic admitted with increasing oxygen requirements. Treating acute on chronic respiratory failure secondary to COVID-19 pneumonia/aspiration pneumonia. Acute on chronic hypoxic respiratory failure, Aspiration pneumonia, COVID-19 Pneumonia-polymicrobial bacteremia, Initially ICU admission ventilated, Currently on O2 at 10 LPM, Continue dexamethasone decreased dose to 4 mg daily, taper dose, Blood cultures with enterococci and staph, TEE negative for endocarditis, ID following. Recommending 7-day course of ampicillin given rapid improvement, completed antibiotics on 1/11/2020. Bacteremia likely transient. Appreciate ID input, Patient has increased secretions, started on cefepime on 1/14, ID was re-consulted. Chest x-ray showed multiple infiltrates, CT chest without contrast showed left lower lobe consolidation, mild bilateral pleural effusions. Sputum cultures grew Pseudomonas, pansensitive, continue cefepime for now, change antibiotics as per ID. Consulted pulmonology for evaluating the need for bronchoscopy/mucous plugging, seen appreciate input. Patient has no fevers, low procalcitonin, Pseudomonas likely colonization. Patient appears to be volume up, continue Lasix diuresis, adjust as needed. Hypernatremia, improved, AKI - likely prerenal, Improving, Baseline normal creatinine, continue to monitor, Steroid-induced hyperglycemia, Insulin-dependent DM2, Remains hyperglycemic, Continue NPH 30 U q8h, Glargine 20 U QAM/15 U at bedtime. History of spinal cord injury with quadriplegia, History of traumatic brain injury, Schizoaffective disorder, Continue valproic acid, Latuda, clonazepam, Dyslipidemia, History of coronary artery disease, Continue Lipitor, aspirin. CODE STATUS: Full DVT prophylaxis: Heparin sub Q. Discharge plan: Plan to discharge back to group home when stable, needs hypoxia improvement, currently on 10 L of oxygen, baseline at 5 L.
Initial unsolicited report received from a consumer on 15 July 2015. A female patient, whose medical history and concomitant medications were not reported, had received a dose of DTaP (batch number, route and site of administration were not reported) on unspecified date 11 years ago. On unspecified date after vaccination, the patient had an extreme reaction. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was not reported. Documents held by sender: none.
Tendinitis and Bursitis in the R shoulder joint. Student is unable to dress herself due to pain. Has not seen a MD but is using ice and ibuprofen for pain. Reported to me following a discussion between another student with similar symptoms. Instructed to make appointment with MD for steroids.
SYMPTOMS, NASAL PAIN, THEN HEADACHE LATE THE EVENING OF 04/16/22, THEN 04/17/22 SUNDAY, WOKE FEELING POORLY, FEVER, HEADACHE, LEFT ARM PAIN, REDNESS, SWELLING IN ARM ONLY.  THIS LASTED ALL DAY, MONDAY 04/18/22 ARM STILL SORE, RED, SWOLLEN, STILL NOT FEELING WELL, FATIGUED.  LATE MONDAY 04/18/22 NOTICED THAT ARM WAS HOT SWOLLEN RED, AND FELT WORSE THAN BEFORE, TUESDAY AM 04/19/22, SWELLING IN ARM, SHOULDER AND LOWER NECK ON LEFT SIDE, WENT TO PRIVATE PCP WHO GAVE STERIOD INJECTION, ADVISED TO ICE AND TAKE ANTI INFLAMATORY.  TODAY 04/20/22 ARM STILL RED, SWOLLEN AND PAINFUL, BUT NOT AS BAD AS ON TUESDAY.
Patient had fever of approx 101 on eve of date received vaccines, then had an episode described as eyes staring off and whole body going limp for 5 sec followed by all 4 extremity stiffening that lasted couple of seconds. He then returned to normal with total episode time ~10 sec. He then had another similar episode the following afternoon with return to normal. The eve following receiving vaccination mom heard loud scream from child's room. She picked up child who was awake, alert. He then had another episode of eyes staring followed by going limp. This time he did not return to baseline and stopped breathing. EMS was called. Patient was in cardiac arrest. Required chest compressions upon arrival to ED. Patient coded for 35 min. To pediatric ICU, vent dependent with severe neurological impairment s/p prolonged cardiopulmonary arrest. Patient was terminally extubated.
broke out in hives; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4912695 (RA).  A 42-year-old female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple sclerosis" (ongoing); "Allergic to eucalyptus" (ongoing), notes: If exposed she breaks out in a rash, gets bright red and flaming hot; "rash" (unspecified if ongoing); "gets bright red" (unspecified if ongoing); "gets flaming hot" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: URTICARIA (non-serious) with onset Jun2021, outcome "unknown", described as "broke out in hives".  Additional information: She found out she was allergic to the Pfizer covid vaccine when she broke out in hives in Jun2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Moderna COVID- 19 Vaccine EUA: patient reported a small, raised, and hard area at the injection site 14 days after vaccination that started 11 days after vaccination. During clinic visit 15 days after vaccination lymphadenopathy, erythema, and itching documented and patient reported symptom improvement. Eight days later at annual wellness visit no symptoms reported.
Dizziness, Vertigo, light-headedness which has lasted into 4 weeks post 2nd vaccine
2 weeks after receiving 1st vaccine large, itchy rash appeared at injections site. Caused no pain or side effects other than slight swelling , redness, and itch
MULTIPLE SUBSEGMENTAL PULMONARY EMBOLI WITHOUT ACUTE COR PULMONALE
25 min after shot, my tongue swelled up and mouth was numb for 5 min. Next morning my tongue is still swollen and itchy and little rash on my chin.
Client called office to report lip swelling and shortness of breath.  Took Benadryl with good relief.
shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 77 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2006, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Serious headache in back of head, pain in armpit on left side of body (where injection was). Chills, fever, fatigue.
No adverse event; incorrectly administered a monovalent vaccine to an 11 year old patient instead of the bivalent booster dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (incorrectly administered a monovalent vaccine to an 11 year old patient instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) in an 11-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR4504B) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE (1st dose) on 08-Nov-2021 and COVID-19 VACCINE (2nd dose) on 29-Nov-2021. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE and COVID-19 VACCINE.    On 11-Nov-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 11-Nov-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced WRONG PRODUCT ADMINISTERED (incorrectly administered a monovalent vaccine to an 11 year old patient instead of the bivalent booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (incorrectly administered a monovalent vaccine to an 11 year old patient instead of the bivalent booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (incorrectly administered a monovalent vaccine to an 11 year old patient instead of the bivalent booster dose).    No concomitant medication was provided.  Nurse reported that they incorrectly administered a monovalent vaccine to an 11 year old patient instead of the bivalent booster dose on 11-Nov-2022. Believed that patient got their primary series outside. The dose that was given was at 0.25 ml of the monovalent vaccine (the one for 6-11 years old with the FOR BOOSTER ONLY label). Patient had not reported any adverse event post vaccination.   Treatment medication was not provided by the reporter.
Patient reported feeling of itching in her throat approximately 25 minutes after receipt of her vaccine.  Pulse ox applied: SPO2: 99% HR: 88 w/o signs of distress, SOB, or AMS.  She was able to converse and describe her symptoms.  She was given 50mg PO Benadryl and a medic was assigned to observe her closely for an additional 15 minutes.  Patient's vitals remained normal and she had resolution of symptoms prior to departure from site.
Mom noticed red area on if upper arm the day after vaccinations. Took child to MD the next day 10/24/08. 5cm circular area on Lt upper arm with blanching. Warm to touch. Tender. No fever. Continue to monitor.
This spontaneous report as received from a health care worker refers to an unspecified patients of unknown age and gender. It was reported that since 03-DEC-2014, the patients was vaccinated with RECOMBIVAX HB (dose and route was unknown) for prophylaxis which was improperly stored. No adverse effects were reported. No product quality complaint (PQC) was involved. No additional information was provided by this reporter. Additional information is not expected.
Fever 100.6, headache, muscle ache, and fatigue for 2 days, soreness at the injection site for 3 days
From information received via the telephone at manufacturer on 3/8/02, it was reported that 2 children, a 15 month old and an 18 month old, developed large, local reddened areas at injection site after being vaccinated with Tripedia. The reddened areas were hot and warm to the touch. Both patient were treated symptomatically. One of the patients was treated with Keflex for possible cellulitis; however, the patient's identity was not specified. Reportedly both patients improved. This case is linked to U200200285.
Dose received: 3; Swollen lymph under armpit next to left breast; This is a spontaneous report from a non-contactable reporter (other HCP). The reporter is the patient.  A 28 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date an unknown date in Dec2021 (Lot number: unknown) at the age of 28 years as dose 3 (booster), single for COVID-19 immunisation. Relevant medical history included: "Obesity" (unspecified if ongoing) and "Penicillin allergy" (unspecified if ongoing), notes: Known allergies: penicillin. Concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot number: UNKNOWN), administration date: an unknown date in Feb2021, when the patient was 27 years old, for COVID-19 immunisation and Bnt162b2 (DOSE 2, SINGLE, Lot number: UNKNOWN), administration date: an unknown date in Feb2021, when the patient was 27 years old, for COVID-19 immunisation.  The following information was reported: IMMUNISATION (non-serious) with onset an unknown date in Dec2021, outcome "unknown", described as "Dose received: 3"; LYMPHADENOPATHY (non-serious) with onset an unknown date in Dec2021, outcome "recovering", described as "Swollen lymph under armpit next to left breast". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Lightheadedness, pounding headache, overall body soreness, feeling hot and/cold, sweating when hot, chills when cold, extreme fatigue and weariness. As of the writing of this form, I am still experiencing some lightheadedness, and this morning, I felt very warm, but I overall feel much better.
This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old female patient who received Flu Seasonal QIV Dresden for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. Previously administered products included ZOSTAVAX (dose received in 2009, no any adverse events). On 19th September 2018, the patient received Influenza vaccine Quadrivalent 2018-2019 season (intramuscular) and the 1st dose of SHINGRIX (intramuscular). On 19th September 2018, not applicable after receiving Influenza vaccine Quadrivalent 2018-2019 season and immediately after receiving SHINGRIX, the patient experienced injection site pain and injection site movement impairment. On 20th September 2018, the patient experienced red blotches, erythema and skin warm. On an unknown date, the outcome of the injection site pain and injection site movement impairment were recovered/resolved and the outcome of the red blotches, erythema and skin warm were recovering/resolving. It was unknown if the reporter considered the red blotches, erythema and skin warm to be related to Influenza vaccine Quadrivalent 2018-2019 season and SHINGRIX. It was unknown if the reporter considered the injection site pain and injection site movement impairment to be related to SHINGRIX. Additional information received as follows: The patient received Influenza vaccine on the left arm. Around 1:30 pm, the patient received SHINGRIX on the right deltoid and she immediately felt pain at the injection site and the area was stiff. The pain started to resolve the next day, however, she reported that she experienced a bright red blotch that appeared below the injection site that was about 2 inches wide and it spread in an odd pattern on the side of her arm above the elbow. The area was bright red and hot for a couple of days. By one day before reporting date, she could move her arm without pain and the red area was mildly warm and mostly resolved. She only had a light stain on her arm at the time of reporting.
Migraine started 11 hours after 2nd dose. Migraine has only gotten worse now 60 hours later. Ibuprofen is the only treatment used thus far to combat the migraines.
Culture confirmed pertussis; 1st dose in sereis was DTP on 4NOV92; 3rd dose of vax was Lederle Tetraimmune given 11AUG93; hospitalized on 14AUG93 & discharged on 20AUG93; no contact case identified; No other siblings;
pt did an at home COVID test on 7/30/21 and it was positive; sx included SOB, cough, diarrhea, anorexia, body aches; pt got a Z-pak from her oncology office; at home O2 saturation showed 78% on RA; pt taken to ED where she was given O2 supplementation and did test positive for COVID; given dexamethasone, remdesivir, Lovenox; Vapotherm; worsening hypotension and respiratory distress; transferred to ICU where she was intubated; DNR; eventually made comfort care and died in the hospital
Lip numbness more on left, but bilateral.  Onset 3 hr after injection, worsen over 6 hours.  Improved after 12 hours but did not resolve after 1 month.
Patient reported not feeling well after receiving the vaccine for approximately five nights after vaccination patient reports feeling hot and cold waking her up at night,  a bruise about the size of an orange at injection site, and loss of appetite.
Face feels sore; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Face feels sore) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced FACIAL PAIN (Face feels sore). At the time of the report, FACIAL PAIN (Face feels sore) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was provided  No treatment medication was provided.
Sore Arm After the First Shot; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm After the First Shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01B21A and 048B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm After the First Shot). On 25-Mar-2021, PAIN IN EXTREMITY (Sore Arm After the First Shot) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       no concomitant medications are provided. treatment to the events not reported. patient not experienced any side effects after second dose.
Infant broke out in hives all over body. Began an hour after the vaccinations and still continues through the present time a week later. Infant receiving Benadryl.
Pt called to say injection site was red, itchy and slightly painful. Pt is taking BENADRYL and will contact PCP.