chrisvoncsefalvay/vaers-outcomes huggingface dataset:
84 Y/O male received one vaccine IM injection into Left deltoid muscle at 1 PM on 1/27/18 and the following signs and symptoms occurred: Initial soreness at injection site associated with reduced range of motion in raising Left arm from 180 degrees or full elevation to less than 30 degrees over 4 hour period. This was followed by a syncopal episode at 5 PM where upon patient collapsed to floor of bathroom. There was no head trauma. Immediately prior to episode no chest pain, SOB. Period of unresponsiveness approx 4 minutes. Shortly thereafter had second unwitnessed LOC and tumble into bathtub. Again denies no head trauma. Report had recent PMD exam. No health problem IE elevated BP, EKG problems, CNS trouble. Visited private provider and scheduled for vein surgery next month. Patient's concern was reduced ROM and Syncopal episodes and possible relationship to vaccine.
Side effects with first shot; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effects with first shot) in a male patient of an unknown age 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Side effects with first shot). At the time of the report, ADVERSE EVENT (Side effects with first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.   Reporter did not allow further contact
A 16-year-old patient was inadvertently given the Johnson & Johnson COVID-19 vaccine approved for 18-years-old and older.  No adverse reactions were notes at time of vaccination or during observation time.
On 3/4, pt had some chills.  On 3/5 his R knee swelled significantly.  He had a replacement 2005 and a revision in Nov 2020 that was uneventful.  He had no trauma to the R knee, he just woke to have it swollen and painful.
Confirmed that no symptomatic adverse event was reported / No additional AE; Inbound call from nurse calling to report TE for MMR-II. Caller states product was administered to patient on 7/26/2023; This spontaneous report has been received from a registered nurse, concerning a patient of unknown age and gender.  The patient's medical history, concurrent conditions, historical drugs, and concomitant therapies were not reported.  On 26-JUL-2023, the patient was vaccinated with an improperly stored dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, rHA (recombinant Human albumin) (M-M-R II) injection, 0.5 milliliter/once (lot number U031359 was verified to be valid, expiration date reported and confirmed as 07-OCT-2023), administered as prophylaxis (route of administration and anatomical location were not provided). The vaccine administered had had a temperature excursion of 9.6 degree Celsius (C), during a time frame of 16 minutes, and had a previous temperature excursion during 14 minutes with high of 8.6C. (Product storage error). No symptomatic adverse event was reported.
Swelling - Near Injection Site; Soreness - Near Injection Site; Fever - Temperature of 100.0F; Headache; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE PAIN (Soreness - Near Injection Site), PYREXIA (Fever - Temperature of 100.0F), HEADACHE (Headache) and MYALGIA (Body aches) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE PAIN (Soreness - Near Injection Site), PYREXIA (Fever - Temperature of 100.0F), HEADACHE (Headache) and MYALGIA (Body aches). At the time of the report, VACCINATION SITE SWELLING (Swelling - Near Injection Site), VACCINATION SITE PAIN (Soreness - Near Injection Site), PYREXIA (Fever - Temperature of 100.0F), HEADACHE (Headache) and MYALGIA (Body aches) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications reported. no treatment details reported.
This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history. In 2014, the patient was inoculated with ZOSTAVAX at the pharmacy as recommended for routine adult health maintenance for the prevention of shingles (dose, route, and lot # not provided). The vaccine did not prevent shingles as intended and the patient subsequently contracted a persistent strain condition of herpes zoster or shingles. On or about 06-JUN-2016, the patient was treated by the physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Four days after the booster I took my dog on a walk.  I began to have fast heart rate.  The next several days I had the same feeling even without exercise.  I started to not feel good and very tired over the next few days.  On October 14, 2022, my sons called the ambulance because I was unable to speak.  I was also struggling with my words and recognition.  I went to the hospital and was diagnosed with ischemic stroke.   Although the tests did not indicate a stroke, they treated me as if I had one.  They gave me Tenecteplase and then I was able to speak after that.
Initial report was received from a health care professional on 05 October 2011. A six month-old female patient had received the following vaccines on 27 September 2011 an intramuscular left thigh injection of PENTACEL, lot number C3951AA; an intramuscular left thigh injection of FLUZONE, lot number UT4119AA and a right thigh injection of PREVNAR, lot number F13779 (route of administration not reported). On 29 September 2011, the patient experienced shaking, shivering, monoclonic jerks of extremities and head jerking. The symptoms lasted for "moments" at a time and reoccurred through the day over a 12 hour period and then resolved. The patient was afebrile and not fussy. No further information was available at the time of the report. The outcome was reported as recovered. Documents held by sender: none.
Two weeks after my Bivalent, I was in a store and I started seeing rapid flashing lights to the left of my vision. So I couldn't see to the left. When I was in the parking lot, it took up my entire field of vision. Went back into the store and sat down, they gave me water and started looking stiff and convulsed rapidly for about a minute or two. Paramedics took me to the ER. By the time I got there, it had worn off and told me to stop taking the meds and that's where I stand now. I cannot drive for 90 days and I am seeing a neurologist due to the episode.
Got shot in right arm. Sat in waiting area and within 5 - 7 min felt sick and faint. Dropped to the floor and I could not move. I heard people wanting to sit me up to get me in a chair but I could not move on my own. They lifted me and then I went out completely. I remember dreaming and then within seconds, that is what I was told, I could hear them. I then was taken to an area that they  checked my pulse, BP, and sugar. Blood pressure, I believe was around 92. I usually run around 120 but can run lower. They called an ambulance because I was unresponsive for a bit while on the floor. I was given IV fluids because of concern with BP. I was aware the rest of the time. I felt nauseous, shaky, cold, thirsty, and very weak. I went to the hospital and they did a CBC and differential as well as a chest xray. All were very good. They also did an EKG which was ok. I started to feel better and the doctor said I could drink and since I felt hungry and had a small protein bar. I was discharged around 12:15p. I continued to feel very weak, some nausea, some diarrhea and a slight headache. I woke in the morning very dizzy and off balance with a sore arm, a little nausea and weak. On 4/8/21 I woke up feeling very weak in my limbs. Headache, sore arm and nausea were gone.  By the end of the day the weakness was a bit improved. By 4/9/21 the weakness in my limbs was much better.  Still get a little dizzy if I bend over.
Drug dose administration interval too long; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) (batch number AS7168B) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 11th April 2019 with lot number 477Z7).   On 16-MAR-2023, the patient received the 2nd dose of Shingrix. On 16-MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Drug dose administration interval too long).  The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 30-Aug-2023 The nurse reported he patient had their initial Shingrix vaccine on11 April 2019 then completed the series on 16 March 2023, which led to lengthening of vaccination schedule. The follow-up could not be possible as no contact details were available.
05/09/20/21 I have had a headache all the time, mostly a dull tension in my head. Sometimes it is so bad I cannot focus to see things, walk, concentrate, or balance.
tingling in left side of face and in left fingers. Paresthesia; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Jul2021 13:00 (Batch/Lot number: unknown) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "cavernoma" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing); "Covid-19" (unspecified if ongoing), notes: if covid prior vaccination: Yes; "a few other antibiotics allergy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: PARAESTHESIA (non-serious) with onset 26Jul2021, outcome "not recovered", described as "tingling in left side of face and in left fingers. Paresthesia". It was unknown if therapeutic measures were taken as a result of paraesthesia.  Additional information: The patient not tested for Covid post vaccination. No any other vaccine in four weeks. Unspecified medications took in two weeks. Facility type Vaccine: Pharmacy or Drug Store  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
temperature; This case was reported by a nurse via call center representative and described the occurrence of body temperature increased in a 75-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, 12 hrs after receiving Shingrix, the patient experienced body temperature increased. On an unknown date, the outcome of the body temperature increased was unknown.   It was unknown if the reporter considered the body temperature increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's body temperature was 100.8 degree Fahrenheit, 12 hours after receiving Shingrix. The reporter asked was this an expected side effect.      Lab Comments: Lab test performed on unknown date
I experienced right afterwards fatigue and really bad headaches and body aches for one day. A few weeks later started getting cramps in my legs. I also got abdominal pain and I saw my doctor who did exams and I was told I had a right ovarian cyst. To this day I still have the abdominal pain, it comes and goes. The legs cramps are not present today.
Not received 2nd dose as patient forgot; weight loss; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not received 2nd dose as patient forgot) and WEIGHT DECREASED (weight loss) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for Reflux esophagitis.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not received 2nd dose as patient forgot) and WEIGHT DECREASED (weight loss). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Not received 2nd dose as patient forgot) had resolved and WEIGHT DECREASED (weight loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication was not reported.  It was reported that patient experienced weight loss before dose 1.
Patient reports resolving erythema, burning, rash, and inflammation to R arm at injection site. Ibuprofen reported as effective for R arm. Patient also reports half of  L pinky finger is blue  on the  "underside." Denies  numbness,  tingling, and injury.
Child with GM, sitting on chair and eating, started shaking all over and staring into space, unresponsive to name, episode lasted 45 sec-1 minute. GM noted tactile fever and gave TYLENOL laid down after episode and seemed fine. Seen in clinic on 7-23-10 for Neuro exam. (N) findings.
She thought she was going to die this morning at 6am, her whole body was on fire inside and out/ hot flashes; She thought she was going to die this morning at 6am, her whole body was on fire inside and out/ hot flashes; This is a spontaneous report from a contactable consumer (patient). An 85-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot numbers and expiration dates were not reported), first dose, single in Apr2021 and second dose, single on an unspecified date; both via unspecified routes of administration for COVID-19 immunization. The patient also received estrogens conjugated, medroxyprogesterone acetate (PREMPRO; lot number: DY4344; expiration date: Jan2022; NDC number: 0046-1107-11), oral from an unspecified date in 1991 at 0.625/2.5mg tablet once a day by mouth for an unspecified indication. Medical history and concomitant medications were not reported. The patient reported that she has been taking estrogens conjugated, medroxyprogesterone acetate for 30 years (from 1991) and she has been happy taking for all these years until around Christmas time when she started having horrible, awful hot flashes. At the time of report (27May2021), the patient asked what she should do because she thought she was going to die this morning at 6am, her whole body was on fire inside and out. She read the insert that came with medication and it talked about interactions, she thought it was strange that it said if having problems to stop taking. She asked if she should she stop taking her estrogen. She got her vaccine and asked if there was any chance that there was some connection between the COVID vaccine and the hot flashes starting. She confirmed she received both doses of the Pfizer COVID-19 vaccine. She was trying to avoid estrogens conjugated, medroxyprogesterone acetate in the morning; the doctor just increased her dose for the second time. She stated that she will just take it when she goes to bed and will call an ambulance if it happened again. She did not recall the previous dose she was taking when the hot flashes started and has discarded the package. She jokingly stated that she was 85 and can barely keep it alive. The action taken in response to the events for estrogens conjugated, medroxyprogesterone acetate was dose increased. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Vaccine administered after more than 1 temperature excursion; Vaccine administered after more than 1 temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Apr-2021 at 11:17 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 15-Apr-2021 at 11:17 AM, the patient experienced POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Vaccine administered after more than 1 temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Vaccine administered after more than 1 temperature excursion) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The age of patient was provided as 36.46. Concomitant products were not provided. On 15-Apr-2021, Excursion time was 09 AM temperature was 34 total doses given for the day was 188, condition of vaccine prior to administration was not frozen, vaccine was moved to fridge on 06-Apr-2021 and vial was moved to clinic on 15-Apr-2021. 18 vials were sent to clinic. Vaccine BUD date was 09-May-2021. On 15-Apr-2021, vials were stored in cooler 1, at following time and temperature respectively, 8 AM: 32, 9 AM: 34, 10 AM: 36, 11 AM: 38, 12 AM: 39, 1PM: 43, 2 PM: 44, 3 PM: 44, 4 PM: 42 and 5 PM: 42. 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 Fisher brand 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 during 33 weeks in 2021. The HCP explained that each time a vial was put into a cooler, there was a period of 1 hour or 1 and half hour approximately, when the temperature data logger registered 34 or 35 degree F. Treatment medications were not reported.
I was given the "new" (2nd) shingles vaccine; an injection in the right arm, in the doctor's office. The injection was painful and my arm was immediately sore. The arm stayed sore for the next three days. On the second day, a red rash appeared down my arm in the vicinity of the injection. The rash remained for four days.
patient received moderna vaccine 9/9/22. BUD of vaccine was 8/31/22
Friday started a bad headache that started behind his left eye. Saturday woke up with a blood shot and swollen eye that gradually got worse throughout the day. Moving left eye causes sharp pain.  Lymph notes are very swollen on the side of injection.
Had bumps all over body. Not itchy but bright red. Doctor said from MMR. Lasted 3 days.
Progress Notes        Subjective Patient is a 61 y.o. female who was seen at COVID vaccine clinic today for her first  dose of the COVID 19 vaccination.    She was given the Pfizer vaccination in the left deltoid muscle.   During her 15 minute waiting period after the injection, the patient began to experience left arm paresthesia and aching.  She denied rash, hives, SOA.   This provider was notified of patient reaction and she was then assessed in the emergency bay area.   Monitored patient for severe reaction symptoms, including but not limited to skin changes.   . Pt received injection to LUE, developed paresthesia to LUE, distal to injection site. ROS/PE unremarkable. No red flag findings to warrant further intervention. Clinically, superficial skin nerve involvement. Dismissed after period of observation.       Previous Reactions: none    Objective    Vitals Vitals:   03/16/21 0843 BP: 121/84 Pulse: 74 Resp: 18 SpO2: 100%            Physical Exam Vitals reviewed.  Constitutional:      General: She is not in acute distress.    Appearance: She is not ill-appearing, toxic-appearing or diaphoretic.  HENT:     Nose: Nose normal.     Mouth/Throat:     Mouth: Mucous membranes are moist.  Cardiovascular:     Rate and Rhythm: Normal rate.     Pulses: Normal pulses.     Heart sounds: Normal heart sounds.  Pulmonary:     Effort: Pulmonary effort is normal.     Breath sounds: Normal breath sounds. No stridor.  Musculoskeletal:        General: Normal range of motion.     Cervical back: Normal range of motion.  Skin:    General: Skin is warm and dry.     Findings: No rash.     Comments: No injection site erythema, rash  Neurological:     Mental Status: She is alert.     Sensory: Sensory deficit present.     Motor: No weakness.     Comments: Paresthesia, mild without weakness  Psychiatric:        Mood and Affect: Mood normal.        Behavior: Behavior normal.        Thought Content: Thought content normal.        Judgment: Judgment normal.         Assessment/Plan  Treatment included: no therapy Follow up response to treatment: excellent. Patient discharge: Stable to go home and follow up with PCP.  Differential Diagnosis: Local reaction (arm pain, bleeding/bruising, mechanical irritation, localized rash)    Pt received injection to LUE, developed paresthesia to LUE, distal to injection site. ROS/PE unremarkable. No red flag findings to warrant furhter intervention. Clinically, superficial skin nerve involvement. Dismissed after period of observation.
patient felt dizzy a few minutes after the receiving the vaccine. He was sitting and fainted and fell off the chair and onto the floor. Pt was shaken and got up immediately. Patient hit his head during the fall but did not fall unconscious. Patient had gatorade and felt better within minutes. Pt was asked if there was anyone should be called and he said no. He called his significant other on cellphone to inform her what happened.  Pt stayed at the pharmacy for 30minutes to make sure he felt okay. Patient was called on 3/26 by witnessing pharmacist and informed her that he was okay and felt fine throughout the rest of the day.
Pt was positive at facility on 11/19. Came to ED on 12/26 for ongoing symptoms. Will report breakthrough just in case facility didn't.
Pt reported that they were admin hep B vax in 1988. 3 wks p/ recving the 3rd dose devel pain & swelling in joints. @ time of the report, the sxs persisted & the pt had not recovered. No further details provided.