chrisvoncsefalvay/vaers-outcomes huggingface dataset:
falling a lot lately/ fallen; First dose given on 16Jul2021/ Second dose given on 02Sep2021; eyes are so bad; hit her head; She doesn't sleep. If she sleeps for two hours, she is up for 40 hours; blanked out; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administration date 02Sep2021 (Lot number: FS2580) at the age of 71 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pneumonia" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose: lot number is handwritten on the card and hard to read. Lot number: EW0186 and it was given on 16Jul2021.), administration date: 16Jul2021, when the patient was 71 years old, for COVID-19 immunization. The following information was reported: FALL (hospitalization) with onset Sep2021, outcome "unknown", described as "falling a lot lately/ fallen"; LOSS OF CONSCIOUSNESS (medically significant) with onset Sep2021, outcome "unknown", described as "blanked out"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "First dose given on 16Jul2021/ Second dose given on 02Sep2021"; EYE DISORDER (non-serious), outcome "unknown", described as "eyes are so bad"; HEAD INJURY (non-serious) with onset Sep2021, outcome "unknown", described as "hit her head"; SLEEP DISORDER (non-serious) with onset Sep2021, outcome "unknown", described as "She doesn't sleep. If she sleeps for two hours, she is up for 40 hours". The events "falling a lot lately/ fallen" and "hit her head" were evaluated at the emergency room visit. The patient underwent the following laboratory tests and procedures: magnetic resonance imaging: unknown results.  Additional information: Patient began falling a lot lately in Sep2021, shortly after getting the shots. She has fallen and hit her head maybe 12 times seriously. She has had to go to the emergency room twice. Caller keeps landing on her head. Caller is on oxygen. She her head hits left or right when she falls. She hit the nightstand and the oxygen concentrated. Another time she reached for toilet paper and fell and hit her nose, forehead, and all the way back of her head. She had to go to the hospital and get MRI. She has fallen two other times. One time was out of the chair. She has a chair in there now instead of just a bed. She dozes off. She doesn't sleep. If she sleeps for two hours, she is up for 40 hours. She was in the chair and fell over. She doesn't know what happened. She blanked out. She didn't hit her head that time, but her whole left side. She didn't know where she was or what was going on. There was no call button on that bed. The next thing she knows she was disoriented. She didn't know where her chair was. She got herself up off the floor and the chair was upside down. Caller can't write anymore.   Follow-up attempts are completed. No further information is expected.
102 fever, headache, dizziness, weak, body aches. Given Motin 200mg(1) for fever & aches.
Well basically both my wife and I both started feeling just tired, then we got nasal discharge and a slight fever of 100 degrees. We quarantined ourselves in the house for the last two weeks basically and the interesting thing is we both got Covid tests and my wife was positive and I was negative even though we were both having the same symptoms and illness. We have both just laid around the house and rested and slept.
pt recv vax; T 105.4; encephalitis, bone marrow suppression, visual disturbance, mouth sores;
Vaccine was administered by MD's office on 2/29/00. Exactly 8 hours later, the pt experienced a sudden fever of 103 degrees, pulse of 140, respirations 40, BP of 96/40. Pt was confused and restless.
Warm to the touch; Pink like sunburn; Redness maybe an1.5  inch and a half below the injection; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch), RASH ERYTHEMATOUS (Pink like sunburn), INJECTION SITE ERYTHEMA (Redness maybe an1.5  inch and a half below the injection) and HEADACHE (Headache) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced HEADACHE (Headache). On 19-Feb-2021, the patient experienced INJECTION SITE WARMTH (Warm to the touch), RASH ERYTHEMATOUS (Pink like sunburn) and INJECTION SITE ERYTHEMA (Redness maybe an1.5  inch and a half below the injection). At the time of the report, INJECTION SITE WARMTH (Warm to the touch), RASH ERYTHEMATOUS (Pink like sunburn), INJECTION SITE ERYTHEMA (Redness maybe an1.5  inch and a half below the injection) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  No treatment medication was provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: f/u received on 28 Apr 2021, new ADR updated.
Lightheaded, dizziness, then proceeded to faint. I was in a sitting position and my boyfriend said I passed out for 5 seconds. I vomited immediately after regaining consciousness.
Patient was clinically well at the time and was taking no medications when she received the immunization. She denied any new exposures to other chemicals, medications or substances. Approximately 2 hours after receiving the vaccination, she felt a "tingling that ascended from the hips to the face" over the next hour. When the tingling reached the face she states her lips began to visibly swell and she developed numbness of the tongue. She then developed a "lump in her throat" which did not affect swallowing. She denied shortness of breath, rhinitis, skin lesions or any other symptoms. She presented at the ER where she was given BENADRYL and a steroid injection. She states the symptoms resolved over the next 24 hour period and have not recurred. She received the influenza vaccine for the 1st time on 15 Sept 09 (seasonal flu) and 14 Oct 09 (H1N1) without any adverse reaction.
Severe deltoid pain onset 18hrs after injection; Decreased mobility of shoulder; Minimal bruising; This is a spontaneous report from a contactable physician. A 56-year-old non-pregnant female patient received the unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: unknown) via intramuscular route of administration, administered in the arm right on 31Mar2021 at 16:15 (at the age of 56-year-old) as dose number unknown, single for COVID-19 immunization. Medical history included latex allergy (allergic to latex). The patient concomitant medications included baclofen from an unknown date and for unknown indication. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient was not tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. On 01Apr2021, after 18 hours of injection, the patient experienced severe deltoid pain, decreased mobility of shoulder continuing 5 days post-vaccination and no skin reaction other than minimal bruising. The adverse events result in a visit to the doctors or other healthcare professional office/clinic visit. The patient received prednisolone as a treatment medication for the reported events. The clinical outcome of the events severe deltoid pain decreased mobility of shoulder, minimal bruising was not recovered at the time of this report.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment (PRD/SRD 28Jul2021): This follow-up report is being submitted to amend previously reported information: vaccination facility country added; final sentence updated to No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patient experienced shingles 1 week after receiving the first dose of Shingrix. The reporter consented to follow up.
next AM ran t101.9, h/a gave APAP; cont to run fever x 2 wks c/o h/a cont x 1 mo; appetite poor x 2 wks; refused to eat; mom called MD & instructed cont treating w/APAP; red throat & poss viral problem;
This spontaneous report was received from a pharmacist and referred to a 37 year old female patient. The patient's concurrent conditions included rhinitis allergic, iron deficiency anaemia, costochondritis, human immunodeficiency virus (HIV) infection, hyperlipidaemia, myalgia, chest pain, palpitations and osteopenia. The patient's concomitant therapies included cobicistat, elvitegravir, emtricitabine, tenofovir alafenamide fumarate (GENVOYA) and ergocalciferol. The patient's medical history included injection site reactions (reported as reactions or allergies to unspecified drug). On 25-JUL-2017, the patient was vaccinated with an unspecified dose of PNEUMOVAX23 (dose and route of administration were not reported) (lot# N010109 with expiration date: 20-NOV-2018) for pneumococcal vaccination. On the same day, reported as "within a couple of hours", the patient experienced irritation and swelling at the unknown injection site. On 25-JUL-2017, the patient returned to the doctor's office due to a low-grade fever, swelling and redness at the injection site. The patient was seen by an unspecified physician. The pharmacist reported that the patient was diagnosed with cellulitis on 25-JUL-2017 and received a prescription for an antimicrobial (unspecified). No laboratory diagnostics studies were performed. The pharmacist requested a lot check for PNEUMOVAX23. The outcome of the events was reported as recovering. The relatedness between the events and the PNEUMOVAX23 was not reported. Upon internal review, the event of cellulitis was considered to be medically significant. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1707USA011278:
Information has been received from a office nurse in a physician's office concerning a female in her late teens who was vaccinated with Gardasil. Concomitant therapy included Dtap. Subsequently the patient felt dizzy immediately after receiving the vaccine. Additional information is not expected.
Patient received in error 0.3ml of the pf Covid-19 vaccine the 17- 12yr dose vs the 11-5yr dose. Patient tolerated the vaccine well with no adverse immediate reaction.
Bruising warm to touch. Bruise site: 7 " wide 2" high.
Roughly an hour or two after having the vaccine, I began to feel very hot and itchy. I noticed red patches all over my body that where slowly spreading all over. I contacted the pharmacy who administered the vaccine and they indicated that I should take over the counter allergy medication and follow up with my primary care provider. I took Benadryl every 4 hours to stop the hives and rash from itching. I followed up with my pcp on Monday 8/30. She directed me to report the case,  and go to urgent care. I went to urgent care after work on Monday . The doctor there advised I was more than likely reacting negatively to the vaccine. Not to receive a second dose, she examined the hives and rash, gave me a steroid to take 2 times daily for the following 5 days.
Muscle Aches, Body aches, Lethargy, Headache, Lasted 24hours.
Vaginal necrotic ulcers, fever, chills, aches, lymph node swelling
Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021; This spontaneous case was reported by an other health care professional and describes the occurrence of POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 11-Jan-2021 at 10:05 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 11-Jan-2021 at 10:05 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). In 2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021). At the time of the report, POOR QUALITY PRODUCT ADMINISTERED (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) and PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered after more than 1 temperature excursion during a period of 33 weeks on 2021) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Age of patient was reported as 27.49.  No concomitant medications were reported.  On 11-Jan-2021 at 09:00 A.M., the temperature recorded was 34 degree Fahrenheit, at 02:00 P.M., the temperature recorded was 35 degree Fahrenheit and vial was initially moved to the fridge on 08-Jan-2021 and beyond use date was 07-Feb-2021. Product moved to clinic on 11-Jan-2021  The vials were only punctured right before administration and all doses were drawn from the vial due to high-pace clinic. Temperature recordings were taken using a traceable temperature monitor at every hour. After administration, the vial was returned to the freezer/refrigerator, or maintained at room temperature.  It was reported that the patient was administered with vaccines that experienced more than 1 temperature excursion for 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of time of 1 hour or 1 hour and a half approximately, when the temperature data logger registered 34 or 35 degree F.  No treatment medications were reported.   This case was linked to MOD-2022-566976 (Patient Link).
Case symptom onset was 7/21/2021 which included subjective fever, chills, runny nose, fatigue, dry cough and shortness of breath.  He was tested for Covid 19 on 7/26/2021 with a positive result with a positive result with Rapid-Quidel Nose Swab. As of 7/30/2021 case was still symptomatic.
Rt shoulder and back near shoulder-5 red, raised bumps < 15 mm diameter. Itchy. Will use ice or cold compress prn and hydrocortisone cream prn.
sick tummy; pain in the back of neck; chills; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (sick tummy), NECK PAIN (pain in the back of neck) and CHILLS (chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 17-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (sick tummy), NECK PAIN (pain in the back of neck) and CHILLS (chills). At the time of the report, ABDOMINAL PAIN UPPER (sick tummy), NECK PAIN (pain in the back of neck) and CHILLS (chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported  No treatment drugs were reported for first dose events   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Follow up received on 24 May 2021 and contains no new information On 31-May-2021: Follow-up added for second dose
Lymph node in left axillae swollen, "about the size of a lemon". Painful to the touch.
Menstrual period started 6/9/2021 while on trip with other vaccinated females whose periods started at around same time.  I have had menstruation 90% nonstop since 6/9 with moderate cramping.  BCP prevented menstruation up until 6/9/21.
inadvertently received a dose of Pentacel and VAXELIS instead of Vaxneuvance with no reported AE; Initial information received on 25-Apr-2023 regarding an unsolicited valid  non-serious case received via other health professional.  This case involves a 1 years old male patient who inadvertently received a dose of pentacel and vaxelis instead of vaxneuvance with no reported adverse event.  The patient's past medical history, medical treatment(s), concomitant(s) and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, HEPATITIS B VACCINE RHBSAG (YEAST), HIB VACCINE CONJ (MENIGOCOCCAL PROTEIN), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (VAXELIS) for Prophylactic vaccination.  On 25-Apr-2023, the patient received suspect diphtheria/tetanus/5 hybrid ac pertussis/ipv(mrc5)/hib(prp/t) vaccine at dose of 0.5 ml (lot UJ804AA, Expiry date: 07-Oct-2023) via intramuscular route in the right thigh for prophylactic vaccination (immunization).  On 25-Apr-2023 the patient inadvertently received a dose of pentacel and vaxelis instead of vaxneuvance (wrong product administered) (same day latency) with no reported adverse event.  Action taken was not applicable.  At time of reporting, the outcome was unknown  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Patient reported to the pharmacy today (6/30/19) that she started to experience pain on her right rib-case when she is breathing in and out. She feels fatigue, shivering and pain on the right side of her body.
Death  4/27/2021 Causes of death listed on death certificate: 1) ADULT RESPIRATORY DISTRESS SYNDROME WITH HYPOXIA  2) RAPID ATRIAL FIBRILLATION WITH DIASTOLIC HEART FAILURE  3) COVID-19  Other: COVID-10 ENCEPHALOPATHY, COVID-19 PNEUMONITIS, MULTIPLE MYELOMA, STAGE 3 CHRONIC KIDNEY DISEASE, TYPE 2 DIABETES MELLITUS
10/13/2019 - 12 days after flu shot, he developed numbness of face, feet, and then hands,  and "abnormal hot and cold sensations."  Taken to ER, had negative stroke work up (Head CT, MRA) and stroke ruled out so he left and went home. Next morning awoke and was having diplopia,  was paralyzed in both  his feet, was unable to walk, both hands became more numb, unable to grasp objects, areflexia, returned to ER, was diagnosed with Guillain Barré. Became confused, speech garbled, developed left facial paralysis and eyelid droop, and right sided facial weakness, was lethargic for couple days. LP showed increased number of lymphocytes, elevated protein; Was transferred to higher level of care on 10/18/2019 to Medical Center. Truncal ataxia was noted at that time, reflexes absent, unable to sit up,  still unable to walk. Had further work up,  lots of lab tests, repeat LP similar; CXR showed some old calcified nodes, so underwent bronchoscopy looking for  possible sarcoid but no granulomas were seen in specimens.  Was treated with 5 days of IVIG with signs of slight improvement over that period of time, continued to very slowly improve, , diplopia and Facial CN findings resolved, continued with numbness and weakness of all 4 extremities with very slow improvement.  Given IV steroids after the IVIG, and then switched to oral prednisone. Was hospitalized until November 6, 2019, then transferred to Skilled Nursing Facility, to receive physical therapy, continued on  prednisone.  Final diagnosis was Acute inflammatory polyneuropathy.   Still in Skilled Nursing Facility, very slow recovery of function, still unable to walk independently, somewhat slurred speech, some word finding difficulty. My impression (Not the attending )   Diagnosis is consistent with Bickenstaff's  Brainstem encephalitis with Guillain Barré following Flu shot..
Please note the patient did not receive the vaccine at this hospital so lot # is not available.  Submitting to VAERS since patient had an anaphylactic reaction and unsure if vaccination site submitted.  64 y.o. male who arrived to the emergency department for Allergic reaction.  Patient developed airway, tongue, lip swelling 5-10 minutes after receiving his second Moderna COVID vaccination today.  He was given 2 IM Epipens at site where the vaccine was administered then transferred to ED by EMS.  EMS gave him Benadryl and a DuoNeb treatment.  Patient reported mild relief.  He still reported tongue, oral floor, and throat swelling.  Discharged from ED in stable condition after 4 hours of observation
Fever of 101.1, chills, headache, dizziness, tiredness,and fast heartrate all day 07/29/2008. Advil given twice once a.m. once p.m.
Significant change in menstrual period. On cycle, Significant increase in bleeding, new (large) clotting; Significant change in menstrual period. On cycle, Significant increase in bleeding, new (large) clotting; Significant change in menstrual period. On cycle, Significant increase in bleeding, new (large) clotting; stronger pain and discomfort; stronger pain and discomfort; This is a spontaneous report from a non-contactable consumer (patient). A 44-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 15Apr2021 (Batch/Lot Number: ER8729) at age of 44-years-old as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was not pregnant. The patient experienced significant change in menstrual period. on cycle, significant increase in bleeding, new (large) clotting, stronger pain and discomfort, all on 17Apr2021 with outcome of unknown. No COVID tested post vaccination.  No follow-up attempts are possible. No further information is expected.