chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Information has been received from a licensed practical nurse concerning a 15 month old male who on 02-JUL-1996 was vaccinated with a first dose of MMR. Subsequently, the patient developed hives "following the vaccination". Unspecified medical attention was sought. It was also reported that on 25-APR-2000 the patient was vaccinated with a dose of Varicella. Then on 01-MAY-2000 the patient was vaccinated with a second dose of MMR at a different office. No problems were reported with the second dose of MMR. No further information was available. There was no product quality complaint involved. Additional information has been requested.
This spontaneous report as received from registered nurse refers to her 21 years old son with no pertinent medical history and no drug reactions or allergies. The patient was vaccinated with the first and the second dose of GARDASIL (dose, route and lot number not reported) on an unknown date and on 29-JUN-2012, respectively. No other co-suspects were reported. No concomitant medications were reported. Nurse reported that her sone on unknown date, had experienced slight tenderness and swelling at the injection site after his first dose of GARDASIL. Nurse also reported that on an approximated 29-JUN-2012, her son developed 3 red, raised, itchy areas, softball size on his right arm, after receiving his second dose of GARDASIL. Nurse stated that he developed slight redness and swelling at the injection site that day (on 29-JUN-2012). It was also reported that by 11-JUl-2012, the redness, swelling, and itching had become worse and included 2 additional areas of softball size redness, swelling and itching, one just above his right elbow and the other on his right wrist. No lab studies were performed. Treatment for the patient's event that occurred after second dose of GARDASIL included BENADRYL, IVYSTAT, hydrocortisone cream (manufacturer unknown) and prednisone (manufacturer unknown). At the time of report, the patient's outcome regarding to slight tenderness and swelling at the injection site after his first dose of GARDASIL was unknown and outcomes regarding to all other patient's events that occurred after the second dose were not recovered. The relatedness for GARDASIL was not reported. Reporting nurse considered severe itching to be disabling (interfering with school). Follow-up information has been received from registered nurse refers to her 22 years old son who indicated that there was only slight reaction (as indicated in circular) after the 1st dose of GARDASIL (date not reported). Registered nurse also reported that with 2nd dose of GARDASIL, the reaction was disabling. Lot numbers were not reported. It was reported that a present (25-JUL-2012), the patient was not symptomatic but did still had three raised areas ranging in size from three to five centimeters. The patient did not seek medical attention, but did receive prednisone from health care professional contact of the mother. The relatedness for GARDASIL was not reported. Reporting nurse considered reaction with 2nd dose (previously reported as "3 red, raised, itchy areas, softball size on his right arm") to be disabling. Additional information has been requested.
Presented via EMS w/ SOB, AMS from nrsg. home. Reported recent Covid+. Tx w/ Decadron, O2
MMR titer drawn 6/7/11-resulted in negative measles antibody IgG K1A: therefore, plan to revaccinate initiated. 7/26/11-Reported seeing stars and then tunnel vision after standing immediately following MMR administration. Resolved <10 minutes with sitting & cool drink. 7/27/11-AM called & reported onset of weakness elbows & below and knees & below shortly after leaving health dept. 7/26/11. Also reported swelling bilateral hands & feet, worse (R) hand, vomiting last pm & night and vision changes (reading using over the counter eye glasses). 7/28/11- Nausea, swelling & vision resolved. Residual bilateral upper extremity weakness persisting.
Had a slightly sore arm after vaccine; This is a spontaneous report from a contactable Consumer via Pfizer sales representative. This Consumer reported about a patient of unknown age and gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number/Exp. date unknown) on unknown date via unknown route of administration at single dose for covid-19 immunization. Relevant medical history and concomitant medication were not provided. On unknown date, the patient reported of having a slightly sore arm after vaccine. The outcome of the event was unknown. It was unknown if patient received any treatment for the event.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
pt recvd vax & devel chicken pox p/the vax; No further details were provided;
Patient received vaccine and five minutes after injection he began to see dots, slowly progressed to the floor and passed out. Patient reports hitting his head. After recovering patient states he woke up with healthcare personnel making sure he was ok. He describes his experience as taking deep breaths, he felt chills, sweats and nausated.  He refused further treatment.
ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/29/2023 HTN (HYPERTENSION) CRITICAL ILLNESS POLYNEUROPATHY 4/6/2023 HTN (HYPERTENSION) ACUTE HYPOXEMIC RESPIRATORY FAILURE 4/29/2023 NONTRAUMATIC ACUTE KIDNEY INJURY CRITICAL ILLNESS POLYNEUROPATHY 4/6/2023 NONTRAUMATIC ACUTE KIDNEY INJURY
Bradycardia; Chest pain; Shortness of breath; Sinus bradycardia; Symptomatic sinus bradycardia
Pt recvd 3 doses of Engerix-B & titer test results indicated that pt did not seroconvert; booster doses will be given;
Chills Redness at site Fever 100-101 degrees Aches Headache Loss of appetite
Vesicular eruption c/u varicella Zoster - S/p ZOSTAVAX.
This spontaneous report was received from a registered nurse referring to a female patient of unknown age. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unknown date, the patient was vaccinated with M-M-R II rHA lot number N009799 and expiration date of 24-MAR-2019, subcutaneously for prophylaxis. The nurse reported that the patient only received a half of the recommended dose of M-M-R II vaccine due to half of the vaccine sprayed out of the syringe during administration. No adverse effects were reported. A Product quality complaint was filed for this defect.
MENACTRA at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes, with no adverse event; menactra one dose was administered post excursion, with no adverse event; Initial information received on 06-Sep-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to cases 2022SA373167, 2022SA372581 and 2022SA372123.  This case involves a 17 years old male patient who received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] and it was found out that menactra at a low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes, with no adverse event and menactra one dose was administered post excursion, with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 29-Aug-2022, the patient received a  dose of 0.5 ml of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE (formulation, strength: unknown) lot U7492AB, expiration date: 26-Oct-2023, via intramuscular route in the left arm as Immunisation.  On 29-AUG-2022 the menactra one dose was administered post excursion, with no adverse event (poor quality product administered) same day following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE. This situation was reported as a medication error due to administering dose post temperature excursion outside acceptable guidelines per stability standard.  On an unknown date the menactra at a low of negative 5.1c out of range for 12 minutes and a low of 1.3c out of range for 10 minutes, with no adverse event (product storage error) (unknown latency) following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events (MENACTRA at a low of negative 5.1C out of range for 12 minutes and a low of 1.3C out of range for 10 minutes, with no adverse event, menactra one dose was administered post excursion, with no adverse event).  At time of reporting, the outcome was Unknown for the all.  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.
On 11/04/2022 it started off with a headache, sneezing, scratchy throat and fatigue. I tested positive on 11/05/2022 for COVID-19. I had a telehealth visit on 11/06/2022 and the provider prescribed Paxlovid.
patient waited his 15 minutes for observation.  he walked out of the vaccination clinic about 12:23 & returned at 12:25 due to feeling like his tongue was numb.  he also felt shaky & dizzy
At some time after my 3rd injection, I would say about 4 months afterwards, I got very weak and I did not want to get out of bed. My blood tests show a decrease in B Lymphocytes.  I am sick with colds and other viral illnesses frequently. In fact, I believe that if a virus is 10-miles away, It knows to contact RN first. Basically, I am often sick. I also began having trouble with my bowels.  I have uncontrolled diarrhea and am now incontinent of urine at times. Of course I do understand that there exists a genetic component to my health problems;  the decline in my general health and overall weakness began to accelerate after getting this vaccination.
Raised, firm, swollen red patch at injection site. Painful to the touch for 3 days after injection. Patch remains sames size 1 week after injection and has become itchy.
Why am I having an allergic reaction to the vaccine?; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Why am I having an allergic reaction to the vaccine?".  Additional information: Why am I having an allergic reaction to the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
high dose flu shot usually reacts on me; Initial information received on 07-Oct-2021 regarding an unsolicited valid Social Media non-serious case from a consumer/non-health care professional.  This case involves a patient (unknown age and gender) whom high dose flu shot usually reacted (vaccination complication) after receiving INFLUENZA VACCINE.  The patient's medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious high dose flu shot usually reaction (vaccination complication) (unknown latency) following the administration of vaccine.  It was unknown if the patient experienced any additional symptoms/events  There were no laboratory data/results available.  It was not reported if the patient received a corrective treatment.  It was reported "Going to wait until after my grandson's wedding Oct 16th. The high dose flu shot usually reacts on me."  At time of reporting, the outcome was unknown for the event.  There will be no information on the batch number for this case.
Administered vaccine that was stored at temperature between -80 degree F to -84 degree F; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 16-Nov-2021 at 4:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F). At the time of the report, PRODUCT STORAGE ERROR (Administered vaccine that was stored at temperature between -80 degree F to -84 degree F) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product information was not provided. Patient received vaccine which was stored in an ultra-cold freezer at minus 82 degrees Fahrenheit. Treatment information was not provided.   This case was linked to MOD-2021-402935 (Patient Link).
Information has been received from a consumer referring to her 17 year old daughter. Concurrent condition and medical history were not reported. On unknown dates, the patient was vaccinated with 2 doses of GARDASIL (lot number, dose and route were unknown). On 09-DEC-2010 the patient was vaccinated with the third dose of GARDASIL (lot number, dose and route were unknown). Concomitant therapies were not reported. On an unknown date, after completing her series of the GARDASIL vaccine, the patient had contracted an unspecified strain of Human papilloma virus (HPV). The outcome and causality of the event was unknown. Additional information is not expected because there's no contact information provided.
Patient instructed to wait in waiting room chair for 10 -15 min after receiving vaccine. Patient stood up within 5 min after sitting down and fainted. Patient came to within 1 min and was sat up in chair, given cool cloth and orange juice to drink due to patient feeling warm and skin clammy. Window opened for cool breeze. Patient remained seated for 1/2 hour before leaving.
At midnight following the vaccine injection I awoke and felt flu like symptoms, including sweating, nausea and chills. I felt like I may vomit for several hours. I was ill for the next week with no energy or appetite. I was in bed and could not leave the house for a week.    The first four days following the injection were the worst. I was sweating through all my clothes, had body aches,  no appetite or energy. My arm was sore, but the concern was the swollen lymph in my left armpit (same arm that received the injection). The first day the gland was swollen to the size of a golf ball which increased to the size of a tennis wall. It was painful but I could not even put my arm at my side due the swelling of the lymph node. It eventually a week later returned to a golf ball and then a grape. The gland only returned to normal size around June 14th. I read that 10% of the clinical trials experienced my symptoms, so I did seek medical care.
Patient developed ASCUS PAP and high risk HPV detected following 3 GARDASIL vaccines given 2008/2009.
Progressive weakness & episodes of dizziness/fall, septic shock from unknown source, acute renal failure secondary to septic shock, metabolic acidosis, mild DKA, SIADH, newly diagnosed diabetes
Information has been received from a physician concerning a 25 year old female who on 22-MAY-2010, Saturday, was vaccinated with GARDASIL from a different Physician. On 27-MAY-2010, Thursday, the patient presented with hives on her body and some swelling (onset date also reported as 22-MAY-2010). The patient saw her original physician and was prescribed ZYDOL. Later that evening the patient fainted and went to the emergency room. While at the emergency room the patient was given prednisone and BENADRYL. Later that evening the patient had severe swelling among the face and she was admitted to the emergency room again and was hospitalized. On Sunday, 30-MAY-2010, the patient saw the reporter with severe pain in her abdomen and vaginal bleeding. At the time of the reporting, the patient's status was unknown. Additional information has been requested.
Chills, Fever, Nausea, Vomiting, Body Aches, Fatigue
This spontaneous report was received from a pharmacist refers to a female patient of unknown age. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (lot # J000853 and expiration date 23-APR-2013) injected into her left deltoid. Her relevant medical history, concomitant medications and past drug history were unknown. On 22-MAY-201e the patient experienced rash around the injection site which "hurts like a bee sting". There was no relevant lab data. The outcome of hurts like a bee sting and rash around the injection site was unknown. As of 25-MAY-2013, it was unknown if she would continue to receive ZOSTAVAX or if she experienced a rash. This is second of the two reports received from the same source. Additional information has been requested.
a 6 year old patient was given FLUBLOK with no AE; 6 year old inadverntly got the FLUBLOK instead of Fluzone Quadrivalent with no reported AE; Initial information regarding an unsolicited valid non-serious case was received from physician via agency (Reference number- 00802581) and transmitted to Sanofi on 07-Oct-2021.  This case involves a 6-year-old male patient who experienced 6 year old inadverntly got the flublok instead of fluzone quadrivalent (wrong product administered and product administered to patient of inappropriate age) while receiving INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient medical history, medical treatment(s), vaccination(s), concomitant medication, and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [lot number and expiry date not reported] via an unknown route in unknown administration site for prophylactic vaccination.  On 03-Oct-2021, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [lot number and expiry date not reported] via an intramuscular route in the left deltoid for prophylactic vaccination.  It was a case of actual medication error due to wrong product administered (On 03-Oct-2021) and product administered to patient of inappropriate age [Latency: on the same day].  Details of laboratory data not reported.  It was not reported if the patient received any corrective treatment for the events.  At time of reporting, the outcome was unknown for 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 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.  There will be no information available on the batch number for this case.
Information has been received from a registered medical assistant referring to a 20 years old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies and concomitant medication were not reported. On 08-JUL-2016, the patient inadvertently administered a pediatric dose of RECOMBIVAX HB (lot # M000442 with expiry date 31-MAR-2016, intramuscular). No adverse effect was reported. Additional information has been requested.
Initial unsolicited report received from a non- healthcare professional on 15 March 2016. This case involves a 27-year-old female patients who were vaccinated with first dose of ADACEL (batch number: U5298AA, expiry date, dose, dose in series, site of administration was not reported) intramuscularly on 11-Mar-2016 (reported as last week). Illness at the time of vaccination was reported as and pre-existing physician diagnosed allergies, birth defects, medical conditions were unknown. Concomitant medications were not reported. The patient was not vaccinated with any other vaccinations 4 weeks prior to the event onset. On an unknown date (reported as last week) following the vaccination, the patient's had developed redness and swelling at the injection site and had fever. The patients required doctor visit. The patient's laboratory data and corrective treatment was not reported. On an unknown date, the patient was recovered from the events. Follow-up report received from a non- healthcare professional on 21-Jul-2018. The patient's age was reported and number of patient was updated from two to one as (based upon the updated narrative). The patient's vaccination history was reported. The patient's details about concomitant history was reported. The event outcome was updated. It was reported that patient only had a doctor visit despite of emergency room visit. List of documents held by sender: none.
Approximately 2 hours after IM flu shot, developed wet cough, dyspnea, chest pressure and inability to expand lung volume. Seen at ER for anaphylaxis. Inhaled epi, long acting B2 were palliative.
This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On 21-AUG-2015, the patient was vaccinated with an improperly stored dose of VAQTA (lot # L009445, exp. date: 01-JUN-2017) (strength, dose and route were not reported). There were no adverse effects reported. This is one of several reports received from the same source. Additional information has been requested.
5 x 10cm erythematous lesion at injection site on post. right arm. (+) warm to touch with reported; itchiness. Onset 24 hours after injection; No reaction to varicella vac 31
Large red itchy blotch on site of injection about 1 week after first dose. Blotch about 3-4 inches in length and 2 inches in diameter
First day of injection 2/23/2021 left upper arm  was sore to touch,  2nd day (2/24/2021)  I had 3 dizzy spells that passed after I took motion sickness BONINE pill.   3rd day (2/25/2021) I had nausea + 1 dizzy spell.  Saw Primary Care Dr on 3/1/2021, She advised to take OTC Benadryl + Zyrtec or Claritin for Hives. As needed.  Dr. took photograph of 2 hives on left shoulder .  She noted all hives were in vicinity of the left shoulder near where the shot was given,, about 3 to 6 inches away from point of injection.).
patient got vaccine at 13:34, went thru observation period, went back to work. Returned to vaccination clinic for complaints of right hand swelling and right arm was the site of vaccination.  Patient had elastic wristband on right wrist.  Patient does not report loss of sensation in hand, grips equal, no shortness of breath, no swelling of tongue or difficulty swallowing. bp 127/90, hr 108, o2 sat 98%. Benadryl 25 mg liq and Pepcid 20 mg tab administered. 15:20 bp 124/88, hr 112, o2 sat 97%, patient reports that hand was less swollen. and she feels better. 16: 10 patient reorts she feels much better, cap refill < 3 secs, grips equal, decrease swelling of hand, no shortness of breath, no racing of heart, no swelling of tongue or difficulty breathing.  16:30 patient reports they feel fine and left clinic
PATIENT REPORTS LINGERING ARM PAIN THAT INTERFERES WITH SOME DAILY ACTIVITIES.