chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Gave diluent portion only; Gave diluent portion only; Gave diluent portion only and a replacement dose; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 49NM5, expiry date 6th April 2023) for prophylaxis.   On 23rd January 2022, the patient received the 1st dose of Shingrix. On 23rd January 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication, inappropriate dose of vaccine administered and underdose. On an unknown date, the outcome of the inappropriate preparation of medication, inappropriate dose of vaccine administered and underdose were unknown.  Additional details were provided as follows: The age at vaccination was not reported. On 23rd January 2022, reporter gave by error Shingrix diluent portion only ,which led to inappropriate preparation of medication and inappropriate dose of vaccine administered  After this, she gave other shot of a correctly reconstituted Shingrix vaccine on the same day,which led to underdose. This was patient´s Shingrix first dose. The reporter did not consent to follow-up.
Patient developed blotchy red rash on chest and abdomen the following day in the afternoon.  No treatment. States it went away on its own in about 2 days .
Woke up and everything blurry, dizziness, finger tips turned bright red & blue capillaries on fingertips, fatigue, and shortness of breath with heart palpitations. About week later ankles became red and hot.
Swelling and tenderness (approximately 2 inches in diameter) at injection site lasting 7 days after the injection. No pain.
Painful arm, swollen with a rash from a hand's width above the elbow up and over the shoulder. She was exhausted, chills, body muscle weakness for a total of 5 days.
had a stiffness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of MUSCULOSKELETAL STIFFNESS (had a stiffness) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (had a stiffness). At the time of the report, MUSCULOSKELETAL STIFFNESS (had a stiffness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided by reporter.
Patient went to sleep shortly after his vaccination. At approximately 1:30 PM he started crying inconsolably. At approximately 3:30 PM he became lethargic, minimally responsive to noxious stimuli, and extremely pale. His respirations were shallow with no cyanosis present. This lasted for about a minute, then his color started returning, and he was more easily arousable, albeit lethargic. Over the course of the next two hours patient returned to normal. I called the Dr office and they stated that it could have been from adrenalin secondary to crying.
Tired headache sore arm no energy diarrhea and not sure if this is just a coincidence but my mouth swelling on April 8th about 2 in the morning.
Pt. had swelling and erythema from upper arm to area just above elbow. About 7 inches circumference 9 inches. Occasional pruritus. He was given BENADRYL & MOTRIN.
17OCT94 flu shot rt deltoid pneumovax lt deltoid 18OCt93 sore, red, warm lt deltoid below inject site 10 x 8 cm area;
Pharmacist is submitted VAERS report about a vaccine administration error. Patient was indicated for Prevnar13, but due to pharmacist dispensing error, patient was given Pneumovax23 instead. It is believed that patient received Pneumovax23 in 2018, so she was not indicated for Pneumovax23 until 2023.  Patient experienced a sore arm after the vaccine. Patient did not report any additional side effects to the vaccine. Patient is concerned about the vaccine schedule for the pneumonia shot, since she received a second Pneumovax23 vaccine before the 5 year gap that is recommended in vaccine guidelines.
This case was reported by a nurse via sales rep and described the occurrence of pain in arm in a female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and activities of daily living impaired. On an unknown date, the outcome of the pain in arm and activities of daily living impaired were unknown. It was unknown if the reporter considered the pain in arm and activities of daily living impaired to be related to SHINGRIX. Additional details reported as follows: The patient was approximately 55 years at the time of reporting. The age at vaccination was not reported. However, it could be 54 or 55 years. The patient received SHINGRIX in mid of May 2018. The patient experienced very sore arm that impeded daily activities. The reporter did not agree to be followed up.
Patient reported no adverse reaction but was administered a vaccine that was beyond its BUD of 05/12/23
I experienced two episodes of heart palpitations while at rest, not something I have experienced regularly before. During both events I was seated at rest, once at a desk, and once in a car driving. In both cases, my heart rate elevated unexpectedly to around 130+ BPM, and included a general feeling of heart beats being out of sync. The beat simply felt wrong or incorrect. The elevated heart rate lasted about 10 minutes, but anxiety and strange feeling of heart beat at closer to normal rate continued for 45 - 60 minutes. In both cases heart activity appeared to return to normal approximately an hour after onset. No shortness of breath, light headedness, dizziness, or other symptoms were experienced. In neither case was further medical attention sought. I would describe the frequency of the condition as mild, but the symptoms as moderate.
Telephone call from mom at 4 PM on 4-25-12 reporting patient had fever last evening after vaacines of 101.6(ax). Dosed with Tylenol. Today patient spiked a temp of 105(AX-Reported by mom). When she called the PCP asked that she bring child in to be checked. On arrival temp was 99.8(AX)Child smiling and mother reports no other symptoms noted at home.No problems with first vaccines.
Itchy palms and feeling on fire, then 48 hours later developed urticaria over body and sense of tight chest.  Swollen lips on 11/12/09.  12/10/09 PCP medical records received. Service date 11/14/09 Assessment: Idiopathic urticaria that could be related to H1N1 vaccine or black tea. Patient presents with rash all over body. Awoke with itchy palms and feeling of being on fire. Was drinking black tea. Entire body with hives, bottom lip swelled. Went to ER tx with steroid injection. Now urticarial rash on forearms, arms, legs, torso.   12/11/09 ED records received. Service dates 9/29/09 to 11/12/09. Assessment: Allergic Reaction Patient presents with rash, hives, lower lip swelling. Angioedema. Skin rash with erythema. Not feeling well. IV Steroids.
Case number PHEH2012US017153, is an initial spontaneous report received from a health care professional on 28 Aug 2012. This report refers to a 49 year old patient (unknown gender). The patient was vaccinated with MENVEO (batch number: M10047), intramuscularly on 27 Aug 2012. The patient had difficulty in withdrawing a full dose of MENVEO from two different vials after reconstitution; therefore they mixed MENVEO from two different vials after reconstitution to administer a 0.5 ml dose to the patient. No adverse event was reported.
chills, headache, fever, nausea ,delirious ,arm swollen and sore
Oral pain, swelling of tongue and oral mucosa, dysphagia/odynophagia symptoms started 1.5 days after vaccination. Treated with BENADRYL.
Approx. 9:00 pm on 6/15/2021 I was relaxing and sitting on my couch for about 2 hours. I was scrolling through my phone reading when I had a gradual onset of confusion to the written word. I recognized that I was struggling to comprehend, so I tried to verbalize the words. I was unable to formulate words and my speech was slurred and garbled. I summoned help and my son drove over to my home. He proceeded to take my blood pressure and heart rate and asses the situation. The symptoms subsided after approximately 5 minutes. I regained my ability to speak and communicate. I went to the hospital the following morning and was admitted for testing. All subsequent scans and blood work all came back normal with no indication of neuro-vascular irregularities. I was diagnosed with a Transient Eschemic Attack or a mini stroke with no known cause. Continuing care will include a baby aspirin and a statin drug to prevent any further strokes.
Chest Pain; Acid Reflux; Weakness; Severe pain under ribcage; Clammy; Warm; Large blood pressure variations going as high 203/98 at peak; Aching; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest Pain), GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), ASTHENIA (Weakness), MUSCULOSKELETAL CHEST PAIN (Severe pain under ribcage) and COLD SWEAT (Clammy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Blood pressure fluctuation (Patient had blood pressure instability issue . Patient had been "in and out" of the emergency room  in the past.).    On 16-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, the patient experienced CHEST PAIN (Chest Pain), GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), ASTHENIA (Weakness), MUSCULOSKELETAL CHEST PAIN (Severe pain under ribcage), COLD SWEAT (Clammy), FEELING HOT (Warm), BLOOD PRESSURE FLUCTUATION (Large blood pressure variations going as high 203/98 at peak), MYALGIA (Aching), HEADACHE (Headache) and NAUSEA (Nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CALCIUM CARBONATE (TUMS [CALCIUM CARBONATE]) at an unspecified dose and frequency. On 20-Mar-2021, GASTROOESOPHAGEAL REFLUX DISEASE (Acid Reflux), ASTHENIA (Weakness), MUSCULOSKELETAL CHEST PAIN (Severe pain under ribcage), COLD SWEAT (Clammy), FEELING HOT (Warm), BLOOD PRESSURE FLUCTUATION (Large blood pressure variations going as high 203/98 at peak), MYALGIA (Aching), HEADACHE (Headache) and NAUSEA (Nausea) had resolved. At the time of the report, CHEST PAIN (Chest Pain) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Mar-2021, Blood pressure measurement: 203/98 (High) Large blood pressure variations going as high 203/98 at peak.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication including Vitamins and supplements was reported.
The patient was given 2 doses of YF-vax one IM and one under the skin. The IM was given by mistake instead of Typhim as he was getting both at the same time. The other YF-VAx was supposed to be for the father who was in the vaccination room with him. We observed the patient for any  adverse effects for 30 mins. He was doing ok. We also checked on pateint the next day as a follow up and he is doing good. The parents were understanding and were ok.
The mother who is an 18 yr old female, with no significant past medical history, and no history of past pregnancies, had received an IM injection of Menactra, lot number 61656AC, on 15Feb06. It was not known that the pt was pregnant at the time of vaccination. The pt was originally evaluated in the physician's office on 15Feb06 for breast tenderness after cheerleader practice. The pregnancy was confirmed at a later date. The date of the pt's last menstrual period was reported as 25Dec05. An ultrasound was completed on 27Jun06 at 20 weeks gestation revealing that the fetus had a mild ventriculomegally versus hydrocephalus. No further information was provided at the time of this report. Per the reporter, the mother has not experienced any adverse events. The information for the mother is reported in the report 200601359.
This spontaneous report as received from a pharmacist refers to a 53 year old female patient with allergy to erythromycin, biaxin and penicillin. On 11-OCT-2014 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot# not reported), 0.5 ml, subcutaneous under the upper left arm. No concomitant medication was reported. Pharmacist stated client was at the pharmacy now with red, swollen, bruised left arm, and client had chills post vaccination. Pharmacist stated client's treatment would be over the counter oral BENADRYL and Ibuprofen. The outcome was reported as not recovered/not resolved. Additional information is not expected since the reporter is not happy to do follow up.
SNEEZING, NASAL CONGESTION, FACIAL PRESSURE, HEADACHE, FATIGUE
Bad body aches; Headache; Pain in the arm that received the vaccine; This spontaneous case was reported by an other and describes the occurrence of MYALGIA (Bad body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain in the arm that received the vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 06-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Bad body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain in the arm that received the vaccine). At the time of the report, MYALGIA (Bad body aches), HEADACHE (Headache) and VACCINATION SITE PAIN (Pain in the arm that received the vaccine) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. No treatment information was provided.  Case comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.   Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: No new information; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
On the 7th day after first dose of covid moderna vaccine I woke up at 8:30 am with a super itchy arm right where I got the shot.  After a couple of hours itchiness continues to occur with some hard swelling circle like around the shot area. The area seems very hard to the touch and is itchy.
On 4/17/2021 I got extreme dizziness and could not walk because I was so unsteady and the room was spinning.  Also tinnitus, nausea tired.
massive seizure; Shoulder popped out; light headed; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SEIZURE (massive seizure), JOINT DISLOCATION (Shoulder popped out) and DIZZINESS (light headed) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus.   On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-May-2021, the patient experienced SEIZURE (massive seizure) (seriousness criteria hospitalization prolonged and medically significant), JOINT DISLOCATION (Shoulder popped out) (seriousness criterion hospitalization prolonged) and DIZZINESS (light headed) (seriousness criterion hospitalization prolonged). On an unknown date, the patient experienced MYALGIA (sore arm). The patient was hospitalized from 02-May-2021 to 05-May-2021 due to SEIZURE, then for 4 days due to DIZZINESS and JOINT DISLOCATION. On 05-May-2021, SEIZURE (massive seizure) had resolved. At the time of the report, JOINT DISLOCATION (Shoulder popped out), DIZZINESS (light headed) and MYALGIA (sore arm) outcome was unknown.            Concomitant product use was not provided by the reporter.   No treatment information was provided. It was noted that the patient never experienced a seizure before. He was treated with Physical therapy and undergone surgery.  Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.   This case was linked to (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Voice loss - Occurred next day after injection  No hx of smoking/chewing/drinking  CPAP machine prescribed 2 days before injection  No rxn to injection day of. No redness/swelling  Spoke with patient on 04/14/2021. Patient stated voice was 'altered' - voice loss by the end of the day each day. PCP visit, no allergy/irritation doctor could find. Prescribed Zyrtec. 2 weeks later, patient still claims voice loss/'altered'.  Describes as 'tickle' in throat
"I" received the second Pfizer vaccine on April 29.On the evening of Saturday May 1, "I" noticed a rash beginning to form around "my" right nipple; A small lump under "my" right nipple.; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EWO172) via an unspecified route of administration in the left arm on 29Apr2021 at 11:30(at the age of 55-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history and no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ERB729) via an unspecified route of administration in the left arm on 08Apr2021 at 14:00(at the age of 55-years-old) as a single dose for COVID-19 immunisation. On 01May2021 at 20:00, in the evening, the patient noticed a rash which began to form around his right nipple and small lump under his right nipple. By 03May2021, the rash and the lump had tripled in size, on 05May2021, the rash and lump had begun to subside. On 06May2021, patient met with his doctor for a physical. The doctor said that was possible the rash and lump were a side effect of the vaccine. On 07May2021, the rash and the lump are almost gone. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events rash beginning to form around the right nipple and a small lump under right nipple was recovering at the time of this report.  No follow-up attempts are needed. No further information is expected.
Patient had completed the VAR form prior to the clinic. Staff was aware that only ages 18 and over could get immunization. They allowed her to have the shot with parental approval, which we as the vaccinators did not notice or approve of.
Recvd vaccines on 3/29/13 and on 3/30/13 rash and itchiness on arm, spread down arm and on back. Rash was colorless, but very itchy.
Patient received vaccine after published expiration date. Moderna Company analyzed vaccine and advised lot 007B21A maintained activity necessary to protect against covid 19 on date vaccine was administered. Also patient did not call in to complain of adverse events. This is administrative error without adverse event.
-Pt reported sore arm after Injection, and claimed she experienced heart palpitations -8/30/21 she still has sore arm, limited range of motion, spasm in left arm from neck down to elbow.
Pain in left deltoid within 3 hours; lasted 72 hours. Slight headache within 6 hours; lasted 48 hours.
11/17/08- Received Tdap (+) BACTRIM (1st time) and developed headache, fatigue, nausea, upset stomach, rash. 11/24/08- BACTRIM discontinued. 11/25/08- Returned to clinic- received Prednisone and Hydroxyzine. Symptoms resolved in 24 hours.
lost sense of smell; Initial information received from the regulatory agency on 18-Jan-2022 regarding an unsolicited valid  non-serious case received from a physician.  This case involves patient  of unknown demographics who had lost sense of smell while receiving vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE  Suspension for injection (strength, formulation, frequency, route, lot number and expiry date was unknown) in unknown administration site for prophylactic vaccination. Information for the batch and expiry date was requested.  On an unknown date the patient developed a non-serious event "lost sense of smell" (anosmia) (unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Action taken with DIPHTHERIA, TETANUS AND ACELLULAR PERTUSSIS VACCINE (ADACEL) was not applicable.  It was not reported if the patient received a corrective treatment for the event (lost sense of smell).  At time of reporting, the outcome was Unknown for the event lost sense of smell.  Reporter causality: related