chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a healthcare student refers to a 67 years old male patient with benign prostatic hyperplasia (BPH), elevated cholesterol, gynecomastia, Gastrooesophageal reflux disease (GERD), hypertension, diabetes, bilateral renal cysts. Patient's drug reactions/allergies included TORADOL and STADOL. The patient was intramuscularly vaccinated with PNEUMOVAX 23 (lot# 672781/1706AA, exp 03-OCT-2013) on 13-JUL-2012. Concomitant medications included TRICOR (unspecified), LIPITOR, FLOMAX (unspecified), levothyroxine, ARICEPT, multivitamins (unspecified), fish oil, baby aspirin, vitamin E, alprazolam, SEROQUEL, CLARITIN, EFFEXOR, lisinopril (manufacturer unknown) and NAMENDA. On 14-JUL-2012, "the following day" of vaccination, the patient developed rash. The patient also stated that his arm was warm, painful, and tender and he felt drowsy. On 26-JUL-2012 the patient called the office and mentioned he felt tingling and pain in his right hand. No treatment was given for the events. No lab diagnostic was performed. The outcome of patient was reported as recovering/resolving. The patient sought unspecified medical attention. Additional information has been requested.
Patient was given vaccine on 6/5/08.  Mother and father brought in child to ED on 6/7/08 for concerns of 5 days of tactile fevers (reportedly before vaccine was given, unknown to MD), 2 days of emesis after feeds, abdominal pain, and one episode of bloody stool.  At ED, MD noted multiple bilious emesis, abdominal pain, bloody mass in rectum, and palpated a "sausage-shaped" RLQ mass; patient was also noted to look tired and dehydrated with decrease in urine output, but had no other symptoms.  Patient was found to have an ileocolic intussusception upon fluoroscopy and air contrast enema, and was reduced.  After over 24 hours of observation and on Flagyl and Rocephin, patient has not had recurrence of symptoms and is tolerating bottle formula, doing well.  It is unclear that patient's intussusception was due to Rotavirus vaccine administration, as patient was febrile prior to administration.  08/08/2008 MR received for DOD 6/7-9/2008 with D/C DX: Intussusception.  Pt seen in ER for fever and vomiting 1 day prior to vax admin.  Returned 6/7/08 twice with fever and vomiting and inability to maintain po intake. With 2nd visit new onset of bloody stool. Dx with gastroenteritis and again D/c home. Later requested to return to hospital with concern for Intussusception. Pt had continued to vomit multiple times now bilious and green. On PE a sausage shaped abd mass noted. Transfered to higher level of care. Upon arrival US confirmed IS, NG tube placed and pt given barium enema which was successful at reduction. did well post procedure and d/c home next day.
Pt reports tingling and decreased sensation in left arm following COVID-19 vaccine.  Recommended follow up with Neurology.
pentacel was administered to a 5 year old instead of the intended kinrix with no reported adverse event; pentacel given to a 5 year old patient with no reported adverse event; Initial information received on 14-Jul-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 5 years old female patient for whom vaccine Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] was administered instead of the intended kinrix with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Measles Vaccine, Mumps Vaccine, Rubella Vaccine, Varicella Zoster Vaccine for Immunisation.  On 14-Jul-2023, the patient of 5 year old received a dose of 0.5 ml (frequency: once) of standard strength dose 5 of suspect Diphtheria/Tetanus/5 Hybrid AC pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (Vero)] suspension for injection (lot: UJ851AA, Expiry date: 01-Apr-2024) via intramuscular route in the left thigh for Immunization, instead of the intended kinrix with no reported adverse event (wrong product administered) (product administered to patient of inappropriate age) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown for both the events.  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 guidelines. 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.
Does not have full use of arm....such big pain; throbbing pain in arm / arm is sore; inappropriate schedule of vaccine administration; cant lift arm; still having problems with her right arm; Does not have full use of the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (throbbing pain in arm / arm is sore), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration), LIMB DISCOMFORT (cant lift arm; still having problems with her right arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Does not have full use of the arm) and PAIN (Does not have full use of arm....such big pain) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 003A21A) for COVID-19 vaccination.     No medical history was reported.    On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced PAIN IN EXTREMITY (throbbing pain in arm / arm is sore), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration), LIMB DISCOMFORT (cant lift arm; still having problems with her right arm) and VACCINATION SITE MOVEMENT IMPAIRMENT (Does not have full use of the arm). On an unknown date, the patient experienced PAIN (Does not have full use of arm....such big pain). On 03-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (inappropriate schedule of vaccine administration) had resolved. At the time of the report, PAIN IN EXTREMITY (throbbing pain in arm / arm is sore), LIMB DISCOMFORT (cant lift arm; still having problems with her right arm), VACCINATION SITE MOVEMENT IMPAIRMENT (Does not have full use of the arm) and PAIN (Does not have full use of arm..such big pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Patient reported she had an appointment with orthopedic doctor on 10-May-2021.  Treatment of events was not reported. Concomitant medications as reported by patient included blood thinner, included blood thinner, cholesterol medication and cholesterol medication and blood pressure medication blood pressure medication.   This case was linked to MOD-2021-033836 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Event outcome updated (to not recovered )and new event (pain aggravated) was added On 14-May-2021: Non-significant Follow accepted on 17 May 2021; Sender's Comments:  MOD-2021-033836:First dose
This spontaneous report as received from a pharmacist refers to 3 patients of unknown age and gender. The patient's pertinent medical history, drug reactions and allergies and concomitant medications were not reported. On an unknown date the patients were vaccinated with improperly stored ZOSTAVAX (dose and route were not reported), lot # M030140 and expiry date: 18-AUG-2017. There were no adverse events reported. No further information was provided. There was no product quality complaint involved. Additional information has been requested.
Severe left arm pain for 2 weeks after injection. Left lateral numbness on the outside of left leg just above, through, and below the knee.
He received tdap 3/17/21; he denies pain at time of injection. He had mild soreness the few days following injection as to be expected with TDAP but it never resolved and arm pain has worsened/progressed over the past few months. Shoulder hurts, pain radiates to elbow and forearm and now to wrist and hand. He has some weakness and sensory changes to his hand, primarily thumb and first 2 digits; he has trouble grabbing things or holding items such as a coffee mug. He cannot sleep on his right arm due to pain but is otherwise sleeping fine. Point tenderness at the site of injection is overall improved/nearly resolved but does have some mild tenderness to palpation. He feels the most pain to his forearm near his elbow
lt deltoid warm to touch & swollen & red w/firmness 7cm x 7cm in size;t99.3 E;
This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 31-AUG-2016, the patient was vaccinated with an expired dose of RECOMBIVAX HB injection 2.5/0.5 lot # K008334, expiration date 09-JUN-2016 (exact dose and route of administration were not provided). There were no concomitant medications reported. There were no adverse effects reported and no product quality complain was involved. Additional information has been requested.
first vaccine she was a little tired about 5 hours later from the first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (first vaccine she was a little tired about 5 hours later from the first vaccine) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Jan-2021, the patient experienced FATIGUE (first vaccine she was a little tired about 5 hours later from the first vaccine). At the time of the report, FATIGUE (first vaccine she was a little tired about 5 hours later from the first vaccine) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment information was provided.   This case was linked to MOD-2021-314586, MOD-2021-314934.   Most recent FOLLOW-UP information incorporated above includes: On 16-Sep-2021: Significant follow up received contain Significant information (Patient pregnancy status)
Tremendous pain in the left arms where the vaccine injection was given. Terrible (unbearable) headache with a high fever. Burning sensation on eyes. So, I require immediate medical assistance for my health.
This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 65-year-old female patient who received SHINGRIX for prophylaxis. On 27th July 2018, the patient received the 1st dose of SHINGRIX. On 27th July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site itching. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site itching were recovered/resolved. It was unknown if the reporter considered the injection site erythema, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were reported as follows: The patient developed puffiness at the injection site after receiving SHINGRIX. The symptoms lasted for three days in July 2018. The reporter did not have lot number of the vaccine.
Information has been received from a physician via a company representative referring to a 12 year old female patient. The patient's medical history, concurrent conditions and concomitant medication were not reported. On an unknown date in January 2016 the patient was vaccinated with the second dose of GARDASIL 9 (dose, lot# and expiration date unknown, intramuscular) and experienced leg tingling and weakness in leg (unspecified which leg). On 12-MAY-2016 the patient was vaccinated with the third dose of GARDASIL 9 (dose, lot# and expiration date unknown, intramuscular). On the same day the patient experienced severe leg tingling and lower back pain (unspecified which leg). On 13-MAY-2016 the patient went to emergency room at hospital A. It was reported that the patient was not admitted to hospital. Outcome of the events was unknown. Additional information has been requested.
This spontaneous report was received from a family nurse practitioner via a company representative and refer to three one-year-old patients of unknown gender. There was no information about the patients' pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. On an unknown date in May 2017, the patients were vaccinated with an expired dose of M-M-R II which expiration date was in April 2017 (strength, dose, frequency, route of administration, anatomical location, and lot number were not provided) for prophylaxis. No adverse events were reported. There was no product quality complaint involved. Additional information has been requested.
Pt. presented with a fever starting the night of immunization. The next morning the pt. awoke with a swollen (L) eye. Treatment was encouragement of OTC MOTRIN and TYLENOL.
Narrative:  90yo male pt had passed away at home on 12/8/2021. He had been  at hospital after an accident where he broke his neck, had a forehead laceration and  bleeding on the brain. He was discharged from hospital with  home hospice. Pt had received vaccines on 1/20/21 & 2/27/21 from a medical provider. This death is not related to vaccine.
Rash - Itch - using Benadryl and hydrocortisone cream.
Chills; tiredness/fatigue; pain in his right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Apr2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st Dose, Anatomical location: Right Arm), for COVID-19 IMMUNISATION. The following information was reported: CHILLS (non-serious) with onset 08Apr2021, outcome "unknown", described as "Chills"; FATIGUE (non-serious) with onset 08Apr2021, outcome "unknown", described as "tiredness/fatigue"; PAIN IN EXTREMITY (non-serious) with onset 07Apr2021, outcome "unknown", described as "pain in his right arm".  Additional information: On 08Apr that when he received his second shot in his left arm, he felt a pain in his right arm where the first shot had been given.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Pt had his Pfizer COVID vaccinations at Medical Center on 2/23/21 and 3/16/21. on 6/8/21 he presented to the office for an apt for Pulsatile tinnitus in right ear x 2 weeks. Pt was examined and Doctor ordered a CBC and MRI with constrast, ENT referral to be scheduled. Pt to start Fluticasone nasal spray. :Pt referred to Neuroradiology
Gave two doses of an expired vaccine to two patients for their Booster on the 29 Mar 2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Gave two doses of an expired vaccine to two patients for their Booster on the 29 Mar 2022) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059h21a) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: JANSSEN COVID-19 VACCINE (Primary series from Johnson and Johnson) on 05-Apr-2021. Past adverse reactions to the above products included No adverse event with JANSSEN COVID-19 VACCINE. Concurrent medical conditions included Penicillin allergy.    On 29-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Gave two doses of an expired vaccine to two patients for their Booster on the 29 Mar 2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Gave two doses of an expired vaccine to two patients for their Booster on the 29 Mar 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient height was reported as 66 inches. No concomitant medications were reported. The patient had not received any other vaccines prior to Moderna vaccine. Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions. The patient did not have any symptoms and did not seek medical care. No treatment medications were reported.   This case was linked to MOD-2022-526971 (Patient Link).
He suddenly was week and dizzy and his legs buckled beneath him and then when I got him standing back up and walking he turned white a sheet and then threw up. The doctors office offered (after I called back from home) that this was an anxiety induced reaction (they see it in a third of patients-yet have NEVER told me this) and to give him more fluids because his blood pressure bottomed out (which caused him to turn white). I administered pedialite and rest... and am still keeping watch to see if there are any long term effects.
1 hr after vaccine noted swollen tongue, sensation of something stuck in throat and sore mouth. Lasted 2-3 days. Did not seek treatment.
Left arm starting itching  on 04/07/2021 then 4 bumps appear should I take benadry
This spontaneous report was received from a medical assistant and refers to a female patient of an unknown age. There was no information about the patient's pertinent medical history, concurrent conditions, concomitant therapies, and drug reactions or allergies. The reporter stated that on 07-APR-2017, the patient was vaccinated with an expired dose of GARDASIL 9 intramuscularly, lot number reported as: L039066, expiration date: 19-MAR-2017 (strength, anatomical location, dose, and frequency were not provided) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
This is in follow-up to report(s) previously submitted on 5/14/2004. Information has been received from a RN concerning a first grade 6 year old  female pt who on 04/16/98 was vaccinated with a dose of varicella virus vaccine live (lot #622850/0537E). Concomitant therapy included a fourth dose in the left deltoid of Hib conj vaccine (OMPC) (lot #626030/003H), a fourth dose IM in the right deltoid diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid (lot #F451-495), a first dose SQ in the right arm of measles virus vaccine live (+) mumps virus vaccine live (+) rubella virus vaccine live (lot #625228/1596N) and a third dose PO of poliovirus vaccine inactivated (unspecified) (lot #F0786C). On 17-Jan-2004, the patient developed chickenpox. There was no relevant diagnostic tests and or laboratory data, no illness at the time of vaccination, and no past medical history. It was noted that the patient recovered. There was no product quality complaint involved. No further information is avaiable. It was noted that pt's from the same source had a similar experience (WAES # 0403USA02088, 0403USA02109, 0403USA02110, 0403USA02111, 0403USA02112, 0403USA02113, 0403USA02115).
N17.9 - Acute kidney failure, unspecified D69.6 - Thrombocytopenia, unspecified
Administration Error:  Patient arrived at this drive-thru vaccination site.  The patient reported verbally she was here for her 2nd dose of Moderna.  She was routed forward for the vaccination where she received a Moderna dose.  Following administration, her chart documentation was completed and it was discovered at that time that her first dose was Pfizer (on 4/6/21, lot# EW0151, left deltoid).  Patient was counseled on error and informed no repeat doses would be needed.  No adverse events were detected in the immediate observation period, and the patient has not reported any further issues to her provider/team.  The clinic team coached to complete documentation prior to administration, especially our step to validate past vaccine history.
injection site pain; injection site warmth; arm pain; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 68-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number K5F5R, expiry date 3rd April 2021) for prophylaxis.   On 16th July 2019, the patient received Boostrix. On 22nd July 2019, 6 days after receiving Boostrix, the patient experienced injection site pain, injection site warmth and pain in arm. On an unknown date, the outcome of the injection site pain, injection site warmth and pain in arm were recovering/resolving.   It was unknown if the reporter considered the injection site pain, injection site warmth and pain in arm to be related to Boostrix.  Additional details were provided as follows: The patient received Boostrix on unknown arm. On 22 July 2019, the patient developed pain in arm, injection site pain, and injection site was warm to the touch. The all events were reported as ongoing. The reporter was consented to follow up. For all events onset date 21st July 2019 were updated as per source document event column, however in narrative it was reported as 22 July 2019.
Pain at injection site; fatigue; Slight swelling at injection site - dose 1; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 10Mar2021 15:15 (Batch/Lot number: unknown) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergies to medications, food, or other products: yes" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ROSUVASTATIN; IBUPROFEN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Pain at injection site"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigue"; VACCINATION SITE SWELLING (non-serious) with onset 2021, outcome "unknown", described as "Slight swelling at injection site - dose 1". Therapeutic measures were not taken as a result of vaccination site pain, fatigue, vaccination site swelling.  Additional information: Facility where the most recent COVID-19 vaccine was administered: withheld. The patient receive no any other vaccines within 4 weeks prior to the COVID vaccine. The patient not diagnosed with COVID-19 Prior to vaccination. The patient not tested for COVID-19 Since the vaccination.  No follow-up attempts are possible. No further information is expected.