chrisvoncsefalvay/vaers-outcomes huggingface dataset:
This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. On 21-OCT-2014, an unspecified number of patients were vaccinated with improperly stored PEDVAXHIB lot # J014279, expiration date: 16-SEP-2016 (dose and route of administration were not reported). No symptoms were reported. This is one of several reports from the same reporter. Additional information has been requested.
During a routine count of vaccine amounts administered, it was noted that a vial of Moderna had been punctured over the recommended 20 times, and all 8 "over-puncture" doses had been administered. No health concerns noted from any clients during the clinic day related to this med error. We are uncertain of which 8 people on our vaccinated list would have received those 8 doses, so the birthdate given is a best guess of one of those 8 people. Moderna has been notified.
This spontaneous report was received from a registered nurse and refers to an unknown number of patients of an unknown age and gender. The patients' pertinent medical history, drug reactions/allergies and concomitant medications was not reported. On an unspecified dates in April 2016, (reported as since 16-APR-2016), the patients might had been vaccinated with improperly stored GARDASIL 9 (lot # L043213, expiration date: 28-AUG-2017; dose and route of administration were not provided). The vaccine was exposed to temperature 6 degrees Fahrenheit for 7 hours. No previous excursion was reported. No adverse effects were reported. There was no product quality complaint. This is one of several reports received from the same reporter. Additional information has been requested.
Loose bowels; Tingling on the right hand, like in the fingers/ tingling down in both arms, wasn't real high; Itching on arms and forehead; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on arms and forehead) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PRURITUS (Itching on arms and forehead). The patient was treated with CORTISONE for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching on arms and forehead) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: patient's email address was updated
pt recv vax 16OCT97 & same day exp erythema @ the inj site;
Conjunctive hemorrhage followed by eye pressure and extensive puss; Conjunctive hemorrhage followed by eye pressure and extensive puss; This is a spontaneous report from a contactable consumer (reporting for herself). A 51-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 02Mar2021 at 17:15 (Batch/Lot Number: EN6198) as single dose for COVID-19 immunization. Medical history included bee stings. The patient's concomitant medications were not reported. On 11Mar2021 at 15:00, the patient experienced conjunctive hemorrhage followed by eye pressure and extensive puss treated with antibiotic and anti-inflammatory. The outcome of the events was recovered on an unspecified date. The patient did not had COVID prior to vaccination and did not tested post vaccination.
Vomiting, indegestion, lack of appetite, weightloss, dizziness, abdominal pain, fever, fainting, listlessness and nausea.  This lasted from date of vaccine in January until end of March.She went to the Pediatrician three times, the Pediatric Gastroenteroligist, a Chiropractor and a surgeon.  She underwent two blood tests, had a stool sample, an ultrasound and a Endosopy with no results found.  She took several anti nausea vmiting medicines, took over the counter medications for her nausea and indigestion. 5/5/05 Records received DOS 1/7/09 to 3/7/09. Includes immunization records. FINAL DIAGNOSIS:  Post vaccination: Flu-like symptoms, fever, chills, nausea and vomiting. Diarrhea. Later developed epigastric pain. Foul smelling flatus. LABS: MCV low, Abdominal Ultrasound WNL  5/11/09 Gastroenterology records received DOS 2/9/09 to 2/19/09. FINAL DIAGNOSIS: Abdominal pain, nausea, vomiting Post vaccination: Flu-like symptoms, fever, chills, nausea and vomiting which subsided, followed one week later with recurrence of nausea, and development of epigastric abdominal pain, diarrhea. Progressed to persistant vomiting, epigastric pain, and severe nausea. Frequent foul smelling flatus.
Received vaccine on 3/2/21. On 3/11/21, noticed my right arm (at injection site) had a raised rash, bumpy and slightly swollen and red. No itching or pain. Applied Hydrocortisons cream 1mg. Today, 3/12 not bumpy but slightly warm to touch and slightly red. I thought that was strange since it's been 9 days since I had first vaccine! Due for next vaccine on 3/30. What do you advise?
After vaccination patient waited 15 minutes and then reported that she was very itchy (chest, abdomen, arms). Skin on chest appeared red and blotchy. Patient was given oral Benadryl, momentary shortness of breath and ill feeling that passed shortly. Patient was monitored for an additional 20-30 minutes before leaving the pharmacy. Still having itchiness at that time but feeling physically better.
Information has been received from a home health nurse concerning an 80's year old female patient with "some kind of chronic respiratory problem" who was vaccinated with the first 0.5ml dose of PNEUMOVAX 23 approximately 11 months ago. On 24-SEP-2009 the patient was vaccinated with the second 0.5ml dose of PNEUMOVAX 23 (lot# 661577/1161X) IM in the right deltoid. Concomitant therapy included a dose of influenza virus vaccine (unspecified) in left arm and COUMADIN. On 25-SEP-2009 the patient's right arm was swollen, red, warm to touch and tender. Unspecified medical attention was sought. The patient was given TYLENOL and moist pack. There were no laboratory diagnostic studies performed. At the time of the report, the patient had not recovered. No further information is available.
I am WELL PAST the second dose for Shingrix; This case was reported by a consumer via interactive digital media and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in July 2021).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 11-MAY-2022 Reporters comment: The patient self-reported the case via interactive digital media. The patient was well past the second dose of Shingrix. The patient stated that, he/she never received a reminder and enquired if he/she should bother. Additional supportive information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. Follow up would not be possible as no contact details were provided.
Faint red rash on right and left arms. Maybe 5 or 6 roughly circular patches about 1 inch in diameter on each arm.
Information has been received from a physician concerning a 9 year old patient who "at a younger age" was vaccinated with a dose of Varivax. Subsequently the patient developed full blown varicella, it was reported that the patient no fever. Subsequently, the patient recovered. Additional information has been requested.
Arm became very tender and Swollen and warm to touch x 6 days muscle strength reduced x 2-3 days
Global myalgias, arthralgias, Ibuprofen 600 mg TID prn.
Pain in left shoulder  Saw a Physical Therapist-said it was bursitis from the flu shot
Sore arm; This s a spontaneous report received from a contactable physician (physician reported for himself). A 65 year old male patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot Number: EN6203; Expiration Date: unknown), via an unspecified route of administration in arm left on 11Mar2021 14:00 (at the age of 65-year-old) as 2nd DOSE, SINGLE for covid-19 immunization at workplace clinic. Patient had received first dose of vaccine Pfizer BNT162B2 (formulation: solution for injection, lot number: EL3247, Expiration Date: unknown) on 19Feb2021 11:00 via an unspecified route of administration in right arm as 1st dose, single for covid-19 immunization. The patient medical history included increased cholesterol and past history of reactive arthritis. The patient's concomitant medications were Atorvastatin, ASA received within 2 weeks. Patient had no allergies to medications, food, or other products. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 11Mar2021 15:00, patient experienced Sore arm for 3 to 4 days. No treatment was given for the event. Patient did not have covid prior to vaccination. The patient was not tested for covid post vaccination. Outcome of the event was recovered.  Information on Lot/Batch number was available. Additional information has been requested.
pt recvd vax 18MAY92 & devel visual problems that were described ashaving serial streaks a/eyes; pt also devel flu-like illness characterized by hot flashes, achy feeling, tiredness & an anxious feeling;
large red welt entire anterior thigh @ site of inj- ice; unconsolable crying >3hrs-APAP
Severe Diarrhea and vomiting x 2 days.  Continued gastroenteritis symptoms x greater than 2 weeks.
Chills, fever, dizziness, fatigue, nausea, unsteadiness -- Chills began at 10 pm, sweating and dizziness and nausea discovered at 1:30 am when rose to go to bathroom, brief loss of consciousness while seated on toilet, need for assistance to return to bed.  Sweating ended within 20 minutes.  Dizziness, nausea, fatigue, and unsteadiness  continued, though gradually decreased, until 12 noon on 2/6/2021.
0430 12/14/21 Patient found with O2 sats in 70s, patient placed on 2L NC and NRB. Sats continued in the 80s, not responding to voice nor sternal rub.  C/V: rapid rate. No murmur. Resp: CTA without wheeze, rales or rhonchi. Abd: soft to palpitation. Ext: No edema. Hands and feet at times were twitching.  A/P hypoxemia with unresponsiveness
COVID vaccine first shot april 21, 2021. Left shoulder. Sore arm next day. Better in less than 3 days. Rolled over in bed early am on April 30 to extreme pain on shot site. Same left upper arm. Swollen, hot to touch red, developed rash on left wrist soon after. Now May 1st, red area at shot site is still hot swollen and getting larger in length down same arm rash is now on both arms and hands. Kinda itchy all over.
Within 15 minutes after receiving the Covid-19 vaccine my son started making a strange sound with his throat. He was repeatedly making a throat clearing sound. I called his pediatrician and asked if this was normal and the woman said yes. He does have a severe peanut allergy and I was concerned that he was having an anaphylaxis event. This throat clearing went on for 2 weeks and he did it constantly. When the throat clicking stopped, both of his eyes began twitching excessively. They are hard tics and have yet to disappear. He also began having extreme pain in both of his legs. He has difficulty walking at times. The pain lasts all day and night. I've tried motrin and Tylenol, but they have zero effect on the pain. I've taken him to his pediatrician, a neurologist, an ophthalmologist, optometrist and an orthopedic. He's scheduled to see a rheumatologist next week. The ophthalmologist recommended I try giving him eye drops for the twitching and see a rheumatologist. The neurologist recommended that he see a rheumatologist as well. The pediatrician sent him to have bloodwork done. The orthopedic had him get xrays and bloodwork done this morning.
Face got puffy; burning sensation on chest and neck, feels like needles; neck area is slightly red about 4-5 inches area; Eyes got puffy; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Face got puffy), BURNING SENSATION (burning sensation on chest and neck, feels like needles), ERYTHEMA (neck area is slightly red about 4-5 inches area) and PERIORBITAL SWELLING (Eyes got puffy) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) 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 19-Mar-2021, the patient experienced SWELLING FACE (Face got puffy), BURNING SENSATION (burning sensation on chest and neck, feels like needles), ERYTHEMA (neck area is slightly red about 4-5 inches area) and PERIORBITAL SWELLING (Eyes got puffy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency. At the time of the report, SWELLING FACE (Face got puffy), BURNING SENSATION (burning sensation on chest and neck, feels like needles), ERYTHEMA (neck area is slightly red about 4-5 inches area) and PERIORBITAL SWELLING (Eyes got puffy) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant Medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Significant FU- Outcome of events provided
Caught a cold; Cough; This spontaneous case was reported by a non-health professional and describes the occurrence of NASOPHARYNGITIS (Caught a cold) and COUGH (Cough) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced NASOPHARYNGITIS (Caught a cold) and COUGH (Cough). At the time of the report, NASOPHARYNGITIS (Caught a cold) and COUGH (Cough) outcome was unknown.            No concomitant drug details were reported.  No treatment details were reported.
injection site pian; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (injection site pian) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Arthritis. Concomitant products included PARACETAMOL (TYLENOL) for Arthritis.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (injection site pian). At the time of the report, VACCINATION SITE PAIN (injection site pian) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not reported.
This person NEVER received a Smallpox Vaccination.  He believes that he was inoculated by a fellow soldier on 07/03/2010.  He was given written and verbal instructions on how to care for the site and bandages.  Verbalized understanding.  Also seen by provider.
Extreme pain and swelling at injection site as well as lymph nodes in armpit - fever, nausea, shortness of breath
3.27:  my left foot was swollen when i woke up 3.28 by 7 pm:  i had hives all over my body, i was itchy everywhere and my throat began to close - i took two benadryl and when to bed 3.29 7 am:  I woke up and my hives weren't as bad - only on stomach and back - continued benadryl 3.30 7 am:  Same as day before - hives on stomach and back - continued benadryl, i threw up due to nausia twice and had diarrhea 3.30 8pm:  I had a fever of 101 3.31 8 am:  I woke up with a few hives on my stomach and back and a fever of between 100-101, i threw up from nausia.
Two days post vax the pt developed an allergic rash on her chest and cheeks and swelling under her eyes.
Systemic: Allergic: Anaphylaxis-Mild, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe
This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A patient (no qualifiers provided) received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYALGIA (non-serious), outcome "unknown", described as "Muscle pain"; CHILLS (non-serious), outcome "unknown", described as "Chills"; ARTHRALGIA (non-serious), outcome "unknown", described as "Joint pain"; PYREXIA (non-serious), outcome "unknown", described as "Slight fever"; VACCINATION SITE SWELLING (non-serious), outcome "unknown", described as "Injection site swelling"; MALAISE (non-serious), outcome "unknown", described as "Feeling little unwell other than arm pain"; BLOOD PRESSURE MEASUREMENT (non-serious), PARANASAL SINUS DISCOMFORT (non-serious), outcome "unknown" and all described as "blood pressure, sinus pressure as well (voice not clear) that have been reoccurring". Additional information: Additional information: Consumer stated that have been experiencing some muscle pain, some chills, joint pain, slight fever, and injection site swelling, just feeling little unwell other than arm pain. They thought those are all the possible side effects that 'normally occur blood pressure, sinus pressure as well (voice not clear) that have been reoccurring'. And hung up the call abruptly. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Patient stood up, fell back in exam chair, eyes rolled back, had some tremors and leaned to side. Event lasted less then 30 seconds. Patients VS taken immediately after and were within normal ranges, patient given water and a candy sucker, patient sat and waited approx 30 minutes after even and VS taken again and were normal. Patient was escorted to parking lot, walked and felt fine. Had no complaints when left facility.
1st dose; arm soreness, body ache and tiredness for 3 days. 2nd dose; arm soreness, body ache and tiredness first two days. Third day, left arm fully sore up to the armpit. Arm swollen area where shot was done. Full body ache, weak, dizziness. Diarrhea from 4am to 7pm. Cloudy mind, heart palpitations.
Right face going numb; Tingling; Numbness in her left arm, through her left breast and armpits.; through her left breast and armpits; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 041L70A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.).   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Feb-2021, the patient experienced PARAESTHESIA (Tingling). On 13-Feb-2021, PARAESTHESIA (Tingling) had resolved.            This case was linked to MOD-2021-015162, MOD-2021-041709, MOD-2021-015162 (Patient Link).
administered a dose of expired pentacel had expired on 16Sep2023 with no reported adverse event; Initial information received on 05-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves male patient of an unknown age and administered a dose of expired diphtheria/tetanus/5 hybrid ac pertussis/IPV(Vero)/HIB(PRP/T) vaccine [Pentacel (Vero)] had expired on 16sep2023 with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 04-Oct-2023, the patient received a expired dose of 0.5 ml of suspect /tetanus/5 hybrid ac pertussis/IPV(Vero)/HIB(PRP/T) vaccine (strength and lot number: not reported; expiry date: 16-Sep-2023) via unknown route in unknown administration site as immunization (expired product administered) (same day latency). Information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.   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.
1. Severe bone pain throughout body (i.e. pain in femur, tibia, extremities, and joints).  Still occurring, 2+ days. 2. Neck pain. 2 days. 3. Headache.  2 days. 4. Severe/moderate testicular pain. Still occurring, 2+ days. 5. Flu symptoms (fever, chills, skin sensitivity). 1-2 days. 6. Eye pain. 2 days. 7. Fatigue. Still occurring, 2+ days. 8. Shooting pains in random locations (ankle, shoulder, knee, chest, etc.), lasting 1-2 minutes. 2 days.
Patient started w/pain in her elbow and wrist which has progressed to monoplegia on her right side.
Headache, Arthralgia, Fever, Diarrhea, fatigue Narrative:  Headache, arthralgia, diarrhea, low grade temp, fatigue; Aleve taken.
After 15 minutes of administration of PREVNAR (PCV-13) given by the pharmacist (I wrote the Rx). Pt developed diplopia and his intermittent ophthalmoplegia.
The patient was given vaccination at 0828 and remained in clinic for 15minutes before departing. Approximately 1 hour later the error was discovered that the vial had been diluted incorrectly. It was diluted with only 0.13 mL instead of the intended amount of 1.3 mL.  The parents were notified and the child returned to clinic at approximately 1052 same day and met with a pediatrician of the clinic. The child has had cough and congestion since having Covid-19 the previous month, but no new complaints since the vaccine was given.  Patient is to take acetaminophen 10ml every 6 hours for 24 hours and a follow-up virtual call is scheduled for next day.
Weakness all over.  Flu like symptoms, fever, shakes, nausea for 24 hours. Too weak to move from bed.
Patient came into clinic for a covid bivalent booster and was given the  covid monovalent vaccine instead. Health department contacted, states no adverse reaction to the patient,  can have the bivalent booster in 2 months per Pfizer policy. Patient called and notified, voices understanding.