chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Initial information received on 03 October 2013 from a health care professional: Concomitant medications included cefdinir and BENADRYL started on 28 September 2013. A 11-year-old child female patient whose medical history was not reported, received in right vastus lateralis dose of MENACTRA (lot number U4583AA, expiry date unknown), ADACEL (C4385AA, expiry date unknown) in left vastus lateralis and FLUZONE (Lot # U47109AD and expiry date unknown) in right vastus lateralis on 25 September 2013. It was reported that the patient experienced right leg swollen, hard to touch, hurts to walk on 26 September 2013. On 27 September 2013, patient stated seen redness, swelling, clear blisters, mild tenderness and slightly warmer than rest of the skin. On 28 September 2013, redness bigger and swelling. Administration site reaction was not reported. List of documents held by sender: none.
This spontaneous report was received from patient's father referring to a her infant daughter. The patient did not have concomitant medications, pertinent medical history and neither drug reactions or allergies. The patient's mother took prednisone (manufacturer unknown) tablets orally (strength, dose, frequency, indication were not reported) during her entire pregnancy (reported in MARRS # 1711USA000292) and continued to take this while nursing. On 29-SEP-2017, the patient was vaccinated with the first ROTATEQ, orally (strength, dose, lot # and expiration date were not provided) for prophylaxis. Other suspect vaccines included diphtheria toxoid, pertussis acellular vaccine (unspecified), tetanus toxoid, haemophilus B conjugate vaccine (meningococcal protein conjugate)(manufacturer unknown) orally, poliovirus vaccine inactivated (unspecified), diphtheria toxoid, tetanus toxoid, and hepatitis B vaccine (recombinant) (manufacturer unknown) (strength, dose, route of administration, lot # and expiration date were not provided for the vaccines) for prophylaxis. Other suspect therapies included prednisone (manufacturer unknown). The father stated that, since that date (29-SEP-2017), she had had one assisted and two unassisted bowel movements. The outcome of gastrointestinal motility disorder was reported as not resolved. The causality assessment between suspect drugs and the event of gastrointestinal motility disorder was not provided. This is one of two reports received from the same source. Sender's Comments: US-009507513-1711USA000292.
Rash on hands, arms, face.  Also, with the first shot had a dry cough about a week after the vaccine. Feeling like i might be getting a cough now.
This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 17-year-old female patient who received BEXSERO (batch number 149001, expiry date unknown). On 7th March 2016, the patient received BEXSERO .5 ml. On 7th March 2016, less than a day after receiving BEXSERO, the patient experienced injection site pain. The patient was treated with MOTRIN. On an unknown date, the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were received as follows: This case was previously reported to a doctor. This case was reported by a certified medical assistant. The patient experienced pain at the injection site, for over 8 days. The patient had been taking over the counter MOTRIN to treat the pain. The reporter did not know the expiration date of the product. The reporter provided the 15th August 2015 as the revision date for the product.
Information has been rec'd from an investigator regarding a pt who rec'd her 3rd doses of Prevnar, Infanrix, and ActHIB vaccines on 8/22/01 as part of a post marketing safety surveillance trial. On 10/30/01, at 9 months of age the infant was found not breathing. Emergency services were called and she was seen in an ER where resuscitation efforts were unsuccessful. The results of an autopsy revealed that the cause of death was Sudden Infant Death Syndrome. The investigator believed that SIDS (expected per package insert) was not related to vaccine administration. The medical monitor's assessment of relatedness is unknown. This report of a serious, labeled event is being submitted in a 15 day time frame as requested by the FDA. Per F/U 4/17/02: Autopsy states wholly liquified blood within the cardiovascular lumens, pulmonary congestion and a benign large tracheal polyp causing 50% occlusion of the tracheal lumen. The right ovary shows the presence of a cyst. There are enlarged lymph nodes.
Itchy rash to the left arm where she got the flu shot. Complaining also of pain on the arm. No induration on needle stick site. Rash started 10/10/17.
Bell's Palsy; The patient was pregnant at the time of vaccination/Delivery date would be on 06Jun2021; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, in right arm, on 24Mar2021 (Lot Number: ER8132, at the age of 44-year-old) as single dose, for covid-19 immunization. The patient medical history was not reported. Concomitant medication included ascorbic acid, betacarotene, calcium sulfate, colecalciferol, cyanocobalamin, ferrous fumarate, folic acid, nicotinamide, pyridoxine hydrochloride, retinol acetate, riboflavin, thiamine mononitrate, tocopheryl acetate, zinc oxide (PRENATAL VITAMINS). Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in right arm on 03Mar2021 (Lot Number: EN6199, at the age of 44-year-old) as single dose for covid-19 immunization and experienced pregnant at the time of vaccination. The patient was pregnant at the time of vaccination. Gestation period was 30. Delivery date would be on 06Jun2021. The patient experienced bell's palsy on 08May2021. Patient visited doctor or other healthcare professional office/clinic, emergency room/department or urgent care due to the event. Treatment included steroid prescription. Patient did not have Covid prior vaccination and did not have Covid tested post vaccination. Patient had no other vaccine in four weeks. The outcome of the event Bell's Palsy was recovering.
3/25 3:00PM PST - Noticed itchy raised red reaction at injection site  3/26 10:00AM PST - Observed circle is no longer as raised (bumpy) but it has now expanded. New sore sensation in underarm.
10 minutes after receiving vaccination, attendee had complaints of feeling "dizzy and fuzzy" and intermittently staring off into space.  Parent,(mother), present at bedside and states staring off into space occasionally is a baseline behavior for attendee but 'seemed worse' at this time.  Vital signs at 4:10pm: blood pressure 130/90, heart rate 124, temp 99F, respirations 22. Blood glucose 93.  EMT present. At 4:20pm attendee assisted to lie down on cot. Paramedics called as attendee felt she should go to hospital. Attendee transferred to gurney at approximately 4:30pm and was looking at her phone and requesting her headphones and drink of water. Pt seemed more attentive and appeared in no acute distress. She was able to stand and move her legs to transfer to gurney. Attendee transferred to  hospital via fire station vehicle at 4:40pm.
This spontaneous report was received from a medical assistant, concerning an unspecified number of patients of unknown ages and gender. The patients' medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. The reporter informed that on an unspecified date, the patients were vaccinated with improperly stored VARIVAX injection, lot #N022986 and expiration date 23-AUG-2019 (strength, dose, frequency and route of administration were not reported) for prophylaxis and with improperly stored PROQUAD, lot #N019248 and expiration date 20-DEC-2018, for prophylaxis (strength, dose, frequency and route of administration were not reported). No adverse symptoms were reported. The temperature of excursion was reported as - 6.3 Celsius degrees during a time frame of 1 hour and 26 minutes. There was no previous temperature of excursion reported. There was a digital data logger involved. This is a non-valid case due to lack of patients' identifiers. Follow up information was received on 14-JUN-2018 from the medical assistant and it was determined that the case is valid because the patient identifier was provided. The patient was a child (greater than 12 month old) and gender was not reported. The patient received only VARIVAX on an unknown date in January 2018. The temperature of excursion was occurred on 02-JAN-2018. This is one among the several cases reported by the medical assistant. Sender's Comments: US-009507513-1806USA010174: US-009507513-1806USA010177: US-009507513-1806USA010176: US-009507513-1806USA010175: US-009507513-1806USA010173: US-009507513-1806USA010171: US-009507513-1806USA010180: US-009507513-1806USA010178: US-009507513-1806USA010179: US-009507513-1806USA010181.
pt recv vax & w/in 24hrs pt devel gen hives & angioedema;pt was hosp & treated;pt recovered from generalized hives & angioedema;
knee surgery scheduled; This spontaneous case was reported by a physician and describes the occurrence of KNEE OPERATION (knee surgery scheduled) 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 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced KNEE OPERATION (knee surgery scheduled). At the time of the report, KNEE OPERATION (knee surgery scheduled) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment and concomitant medications were reported.
small cellulite in area of injection red; pain to the touch; small cellulite in area of injection red; Saturday a little hot; after 24 hours discomfort on the body with slight punches on the skin; This is a spontaneous report from a contactable Nurse. This 51-year-old male nurse (patient) reported for himself. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: FF8841) via an intramuscular route, administered in Arm Left on an unspecified date (at the age of 51-year-old) as a single dose for COVID-19 immunisation. Medical history included Allergic rhinitis sinusitis and the patient previously received clinoril and skelaxine experienced drug hypersensitivity. Concomitant medications included influenza vaccine inact split 4v (FLUARIX QUADRIVALENT, Lot number: NDC: 58160-0887-52) taken for an unspecified indication in the left arm on 29Sep2021 and multivitamin ascorbic acid (VITAMIN C) 1000 mg and free move taken for an unspecified indication. Prior to vaccination, patient was not diagnosed with COVID-19 and patient has not been tested for COVID-19. On 21Oct2021 at 11:00, after 24 hours patient experienced discomfort on the body with slight punches on the skin and then it went away with Tylenol in the night but on the third day (unspecified date) small cellulite in area of the injection red with pain to the touch and on 23Oct2021 today Saturday a little hot, but it was already disappearing the red in the injection area only pain to the touch. Patient did not receive any treatment for the events except after 24 hours discomfort on the body with slight punches on the skin for which patient took Tylenol. The clinical outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sore arm, fever 24 hour, chills, body aches, vomiting, Loose stools, horrible heart burn
Radiating pain up back, up neck with Head Ache. Severe muscle pain, chills
8/19/08 3AM: vomiting + arm pain.  2PM: vomited.  4PM: no longer vomited=slight fever.
Runny nose, sore sinuses, eyes watering and headache. Taking BENADRYL and switching to ALLEGRA.
Autonomic dysfunction-dizzy, fainting, heart palpitations, enlarged heart, sweating, chills, muscle cramps, blurred vision, cognitive functions, shortness of breath, restless sleep,/ no sleep, chest pains
I had symptoms of fatigue for a week. My arm hurt a lot where the injection was. I was given an anti-inflammatory medication 10mg for fourteen days. My arm and shoulder are still sore and its hard to cross over. I have limited range of motion. I had double hip replacement ten years ago but after getting the vaccine, pain started to arise in that area where I had the surgery. I have to go to physical therapy now because of this.
Changes in my menstrual cycle have started. My menstrual cycle was ending as normal, but started back up as if it were starting all over again.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29May2021 11:00 (Lot number: EW0167) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies : Pencillin" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose number=1, product=COVID 19, brand=Pfizer ,lot number=Ew0175, administration time=10:45 AM,, vaccine location=Right arm), administration date: 08May2021, when the patient was 47 years old, for COVID-19 immunization. The following information was reported: MENSTRUAL DISORDER (non-serious) with onset 22Jun2021 15:15, outcome "not recovered", described as "Changes in my menstrual cycle have started. My menstrual cycle was ending as normal, but started back up as if it were starting all over again.". Therapeutic measures were not taken as a result of menstrual disorder.  Additional information: The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19, prior to vaccination. The patient not been tested for COVID-19, Since the vaccination. No any product complaint to report. No medical information request.  No follow-up attempts are possible. No further information is expected.
Information has been received from a pharmacist referring to 2 newborns. Background: Since June 2015, there had been 1645 times (30 minutes each time= 822.5 hours) that the temperature dropped below 36F. Of course, there was 144 times (30 minutes each time=72 hours) that temperature was below 32F, the lowest being 29.7F. On 04-JUL-2015, there was a low temperature of 30.2F. On 15-JUL-2015 the patients were vaccinated with the improperly stored RECOMBIVAX HB strength 2.5/0.5 (units not provided) (lot number K020216 and expiration date of 17-SEP-2016) (dose and route of administration were not reported). There was no product quality complaint (PQC). This is one of several reports received from the same reporter. Additional information has been requested.
Initial unsolicited report received from other healthcare professional on 26 Jun 2018. This case involves 11-year-old female patient (patient was not pregnant, but did not have date of last menstrual period) who was vaccinated with 0.5 ml second dose of MENACTRA (Batch number: U5917AA, expiration date: 30-Jun-2019, dose was not reported) via intramuscular route in left deltoid on an unspecified date. The patients medical history was not reported. It was reported that no other vaccines were administered concomitantly. It was an actual medication error due to incorrect product storage as it was reported that inadvertently given dose of MENACTRA that had been improperly shipped from Vaccine Shop and extra dose administered as 2nd dose was given to 11 years old. It was reported that no signs of adverse reaction were observed. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the 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. List of documents held by sender: none.
This spontaneous report was received from an physician and refers to a patient of unknown age and gender. Their concurrent conditions, medical history and concomitant therapies were not reported. On 13-FEB-2019, the patient was vaccinated with improperly stored dose of VAQTA (exact dose, dose number, route and site of administration were not reported) lot# R010369, expiry date 25-MAR-2019 for prophylaxis. The vaccine was exposed to temperature below 36 degrees Fahrenheit (33.6 degrees Fahrenheit) for 2 hours 37 minutes and digital data logger was involved. There were no previous temperature excursions reported. No adverse effects were reported.
This spontaneous report as received from a pharmacist via a company representative refers to a 67 year old female patient. On 17-SEP-2014 the patient was vaccinated with ZOSTAVAX (1 time shot, lot # K007984) subcutaneous. The pharmacist reported that on an unspecified date in 2014 the patient was hospitalized with a huge purple blister between her shoulder and elbow that was 3 inches long, 1 inch high, and 2 inches wide at the injection site after receiving ZOSTAVAX. Pharmacist did not know what hospital and for how long the patient was hospitalized. The patient was treated with unspecified intravenous antibiotic treatment. The outcome of the event was unknown. The patient sought unspecified medication attention. Additional information has been requested.
Had administered TDaP at approx. 2:00 PM. Noted left side face and jawline swelling. Left side hearing loss. Iced area all night and taking naproxen. Swelling subsided. Jaw tenderness.
Information has been received from a pharmacist student concerning a patient who was scheduled to received ZOSTAVAX (Merck) but was inadvertently vaccinated with VARIVAX (Merck) on 26-MAR-2009.  The patient did not experience any known symptoms.  Follow up information was received from a registered nurse per voice mail.  It was reported the 64 year old patient was vaccinated with VARIVAX (Merck) instead of ZOSTAVAX (Merck).  The nurse reported that "it was her carelessness that led to the incorrect vaccine administered and that it would be helpful if the boxes for VARIVAX and ZOSTAVAX were different in color."  Additional information has been requested.
Patient received adult dose of Engerix (1 mL) instead of intended dose of 0.5 mL.
Sore arm remainder of day of injection,  discomfort  (soreness)  at night
got sick; This spontaneous case was reported by an other and describes the occurrence of ILLNESS (got sick) in a 65-year-old male patient 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced ILLNESS (got sick). At the time of the report, ILLNESS (got sick) outcome was unknown.            No concomitant and treatment medications were provided   This case was linked to MOD-2021-034296 (Patient Link).
Thinning retinas I had to have 2 surgeries for torn retina and then for a detached retina on my left eye . I have an upcoming surgery for a thinning retina on my right eye.
skin rash (atopic dermatitis) on lower extremities for the next 36 hours
76 patients that received, instead of the 0.3 single dose they received the entire vial of vaccine of the Pfizer COVID-19 vaccine after dilution.; This spontaneous report from a contactable pharmacist reporting same event under the same suspect product for 76 patients. This is one of 76 reports. A patient of unspecified age and gender received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in Apr2021 (Batch/Lot number was not reported) at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The pharmacist reported that she had 76 patients received, instead of the 0.3 single dose they received the entire vial of vaccine of the Pfizer covid-19 vaccine after dilution. The pharmacist would like to know if they need to get the second dose of the vaccine. This occurred in Apr2021 (reported as 22 days before 14May2021) and was getting ready to give second dose, but wanted to see if that was still needed. The pharmacist stated age range was from 30 to over 80 years old.The patient did not provide information to the reporter regarding the reported adverse event with the use of the product. The pharmacist did not consider the Pfizer product had a causal effect to the adverse event.  Follow-up (12Aug2021): This is a follow up-spontaneous report from a contactable pharmacist included that: lot/batch number cannot be obtained.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) :PFIZER INC-2021620745 same reporter/drug/event, different patient
3 1/2" wide 2" length  swollen, redness, tenderness at injection site Lt leg turned gray and eyes rolled back into head per dad after shots. Mom has "weird" reactions when receiving anything.
Pt recvd vax on 9JUN92 & exp blotchy facial rash & skin felt tight & sensitive in the cheek area; pt devel swelling around eyes; knees were swollen w/no redness or itching; pt also c/o rt lower quad throbbing & pulsating discomfort;
The morning after getting the shingles vaccine the patient developed a swollen painful lump on her left  collar bone. It went away in a few of days and she is fine now.
Information has been received from a physician concerning a 4 year old female who 2 to 3 years ago, in approximately 2001 was vaccinated with a dose of varicella virus vaccine live.  On 04/21/2004 the patient was diagnosed with chickenpox with 10 lesions.  It was reported that the patient had a cough and cold symptoms with a slight fever prior to 04/21/2004.  It was noted that the patient was exposed to chickenpox at daycare.  Medical attention was sought, but no treatment was required.  No product quality complaint was involved.  Additional information has been requested.
Patient presented to emergency department on 1/25/2022 due to respiratory failure. She was found to be COVID-19 positive. Patient was treated with supplemental oxygen and dexamethasone. Patient was discharged home on 1/27/2022.