chrisvoncsefalvay/vaers-outcomes huggingface dataset:
expired dose was given; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 2-month-old male patient who received DTPa-HBV-IPV (Pediarix) (batch number 23YL4, expiry date 4th April 2022) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 13th June 2022, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 13th June 2022, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was recovered/resolved.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 13-June-2022 Reporter's comment: The nurse reported that an expired dose of Pediarix was given to a patient on the day of reporting. The reporter consented to follow up. Additional Supportive Information: The patient received Pediarix which was already expired which led to expired vaccine used.
Initial adverse event was severe sickness the day after the vaccine.  I was extremely ill for 3-4 days after the vaccine with flu like symptoms.  Fever, chills, body aches, head ache.  1-2 weeks after that I developed extreme joint pain in two specific areas.  My left index finger knuckle, and my right knee.  My index finger had extreme pain, was sensitive to touch, and would lock into position as I slept requiring me to gradually wiggle it (painfully) to gain function in the morning.    My right knee became very sore to the point that it was hard to walk my dog, and the knee felt unstable and painful with any twisting or torquing moves.  The two conditions persisted for 2 months before worsening.  The specific pain moved from the middle knuckle of my index figure to the base knuckle, the pain in my knee also spread to a sharp pain in my ankle, and I developed a specific pain (exact location) in my head that would hurt when I coughed, bent over or clenched (like when peeing).  At that point I went to the doctor to be checked out.
This case was reported by a consumer via call center representative and described the occurrence of shivering in a 65-year-old female patient who received SHINGRIX. Concurrent medical conditions included chickenpox, measles (twice as a child) and rash (diagnosed a couple of months ago). Concomitant products included Vitamin B12, vitamin D, vitamin E, aspirin, calcium, bupropion XL and nystatin. On 29th January 2018, the patient received the 1st dose of SHINGRIX. On 29th January 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, tremor and nocturnal awakening. On 30th January 2018, the patient experienced feeling of warmth, muscle pain, flu symptoms, pain in arm, general body pain and injection site pain. In January 2018, the outcome of the tremor was recovered/resolved. On 29th January 2018, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the feeling of warmth, muscle pain, flu symptoms and pain in arm were not recovered/not resolved and the outcome of the nocturnal awaking, general body pain and injection site pain were unknown. The reporter considered the shivering, feeling of warmth, muscle pain, flu symptoms, tremor and pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the nocturnal awakening, general body pain and injection site pain to be related to SHINGRIX. Additional details were reported as follows: Yesterday at 1:48 PM, the patient received the first dose of SHINGRIX and woke up in the middle of the night and was shivering and shaking uncontrollably. One day after vaccination, the patient experienced feeling of warmth, muscle pain, flu symptoms, pain in arm, general body pain and injection site pain. The patient said that everything felt warm and the shaking and shivering lasted a good 45 minutes before it resolved. On 30th January 2018 the day of reporting, she had a sore right arm and aching all over which she described as flu like aching. The patient's muscles hurt and everything aches. She also experienced a sore right arm at the injection site. The reporter related the symptoms to the SHINGRIX vaccine. Reporter was surprised by her response because she only had two medications that did not agree with her which include Codeine and Lidocaine over the years.
after receipt of TWO doses of above named vaccine in the SAME day- 3hrs following vaccination, pt began experiencing anxiety, vomiting, chills and hypertension
Doses administered after 30-day use by date; Date the vial was initially stored in the refrigerator: 17Dec2021/Date of administration of vaccine: 21Feb2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 17Dec2021/Date of administration of vaccine: 21Feb2022) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 17Dec2021/Date of administration of vaccine: 21Feb2022). On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 17Dec2021/Date of administration of vaccine: 21Feb2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported. Treatment medications were not reported. On 17 DEC 2021 vial was initially stored in the refrigerator.
Baseball size redness, feels very hot, itchy and firm to touch on injection site, on day 8 since the vaccination
56 adults patients received doses after its expiration date Jul 13, 2022; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 004m21a) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (56 adults patients received doses after its expiration date Jul 13, 2022).    This case was created for 29th patient of 56 patients involved. Concomitant medication was not provided. It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Doses were administered after 30-day Use By Date or after manufacturer date of expiry. It was unknown to HCP when the vials were stored in the refrigerator and when the doses were administered. The vial had not underwent temperature excursion. Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-701125 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-701125:Master case
Wheezing, chest tightness, dizziness, stomach cramps, nausea
Persistent headache (5 weeks) - Extra Strength Tylenol Persistent nausea - untreated Persistent bloatedness - untreated Lack of appetite - untreated Sleep disturbance - untreated Chills - untreated Exhaustion - untreated Inability to work for first three of the five weeks
No adverse event at this time.  Due to the medical failure to check both the patients immunization record and the vaccine registry, the patient received two different manufacturer mRNA vaccines.  Monderna on 03/23/21 and Pfizer on 06/08/21.  The patient did no-show two appointments for the second Monderna vaccine on both 04/23/21 and 05/21/21.
Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information has been received regarding the patient's past medical history, concurrent conditions, or concomitant medication. In 2013, the patient was inoculated with ZOSTAVAX vaccine (lot number, dosage and route of administration not provided), administered at a medical center (by an unspecified healthcare professional) as recommended for routine adult health maintenance for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, also known as shingles and other complications. On or about 02-JUL-2016, the patient was treated (by an unspecified healthcare professional) at a medical center for a blistering vesicular outbreak, which was diagnosed as severe herpes zoster or shingles. As a direct and proximate result of ZOSTAVAX vaccine, and or despite receiving ZOSTAVAX for the long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a direct and proximate result of these malfunctions, 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 reporter considered the events to be related to ZOSTAVAX. The outcome of the events is unknown. Additional information has been requested.
Fever; Migraine; Nausea; Throwing up; This is a spontaneous report from a contactable healthcare professional (patient). A 32-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot: EL3247), intramuscular on the left arm (at the age of 32years) on 27Jan2021 at 14:00 at single dose for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Medical history included migraines, kidney stones and high cholesterol. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not tested for COVID-19. The reported adverse events were fever, migraine, nausea, and throwing up on 31Jan2021 with no treatment received on all events. The patient considered the events as non-serious. Did not results in death, non- life threatening, did not cause/prolong hospitalization, non-disabling/incapacitating and no congenital anomaly/birth defect. The outcome of the events was unknown.
High fever.  Aches chills.  Sob.  4 days.  Passed on 1/27/2021
Pt recvd a series of Engerix-B on 13MAR91; 15APR91 & 11SEP91 & upon completion of series pt was discovered to have not responded;
Baby gagging, choking, and not breathing, went limp, pale - this lasted about 5 minutes.  After this he started moaning as if in pain and this lasted over an hour.  Baby seemed dazed as if in a trance lasting on into the evening. I had no way to the hospital and was sure he would get better as the doctor assured me these vaccines were safe.  He was given 6 shots at one time.
Arm Pain - Near Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm Pain - Near Injection Site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 011L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (Arm Pain - Near Injection Site). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (Arm Pain - Near Injection Site) outcome was unknown. Not Provided          Action taken with mRNA-1273 related to the event was not applicable. Concomitant medication details was not reported by the reporter.
High fever; Body aches; Stomach upset; Nausea; Diarrhea; This is a spontaneous report from a contactable consumer (patient). A 52-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiry date not reported) via an unspecified route of administration on 25Jan2021 at 18:30, Unknown, SINGLE dose for COVID-19 immunisation. The patient medical history included epilepsy, asthma, migraines, diabetes. The patient was allergic to tetracycline and cinnamon. The patient's concomitant medication (s) included topiramate (TROKENDI), oxcarbazepine (TRILEPTAL), verapamil (VERAPAMIL), fluoxetine hydrochloride (PROZAC), Pentobarbital sodium (NEMBUTAL). The patient did not received any other vaccines within four weeks prior to COVID vaccine. The patient did not have COVID before vaccine and no COVID test was done after COVID vaccine. On 27Jan2021 at 13:00, the patient experienced high fever, body aches, stomach upset, nausea, diarrhea. The patient did not received any treatment for this events. All the events were non-serious. The outcome of all the events were recovering.   Follow-up attempts have been completed and no further information is expected.  Follow-up (16Apr2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
He received 2 shots in R/deltoid. Today he is c/o muscle spasms & pain in that shoulder since he has received the injections.
Report received from a nurse on 21-Dec-2009.  A 34 year-old female patient received H1N1 vaccination (lot 00349611A) via intra-muscular injection into the left deltoid on 13-Nov-2009 (pm).  The patient has a medical history of asthma.  At the time of vaccination, patient had no illnesses.  Concomitant medications are unknown.  On 13-Nov-2009, the day of H1N1 vaccination, the patient developed a headache.  On 14-Nov-2009, the patient reported feeling lethargic without a headache.  On 15-Nov-2009, the patient reported feeling unwell, had increased lethargy, was congested, and had an irritated throat.  On 16-Nov-2009, the patient awoke with dyspnoea and chest heaviness.  The employee went to her physician and received breathing treatments, steroid pack, Ceftriaxone injection and was diagnosed with a right ear infection.  The patient outcome is not yet recovered.  Awaiting further information.  Information derived from this AE report does not change the current safety profile of the product.  Batch review request received for 00349611A on 29-DEC-2009.  On completion of this investigation, it has been determined that all deviations related to the manufacture of this lot were assessed as having no impact on product quality.  All QC testing was satisfactory with no out of specification results reported.  There are no outstanding issues related to this lot that would potentially affect product quality.  In conclusion, there has been no assignable cause drawn from this investigation that would indicate any association with the adverse event reported.  Follow-up information received on 28-DEC-2009.  The patient was not pregnant and outcome is completely recovered.
Developed myocarditis.  I take 25mg of Metrprolol daily. Immediately after vaccination I felt violently ill. From May until September I had consistent dizzy spells, almost fainting, high blood pressure, and chest tightness. Body temperature changed as I was always very hot.
Student was given an expired dose (1 week expired) prior to documentation & medical assistant did not check expiration prior to giving injection. Sanofi was notified & advised to give repeat dose, which was given same day as initial booster dose.  Patient reported no adverse reactions in subsequent follow-ups x1 week.
I have had tingling feelings all over body for 21/2 weeks now ..... I am very scared and have been to the ER twice and they won?t do a lumbar puncture to check for Gillian Barre because my symptoms aren?t bad enough - I don?t want to wait ! This is Very scary
Patient is fully vaccinated. COVID + 2/2/2022 on admission to hospital. Patient admitted with neck pain ans shoulder pain.  The patient also described left-sided vague chest pain, while still in emergency room patient developed severe tachycardia. Labs: cr 2.12, Hg 8.7, Plts 119, Troponin elevated. CXR: Mild nonspecific prominence of the interstitium may be related to pulmonary vascular congestion or less likely infiltrates. assessment:  CHF, afib iwth RVR, chronic kidney disease. Medications:  heparin, antibiotics, insulin, linezolid. Pt went into shock, ventilator, patient expired.
This spontaneous report was received from a pharmacist concerning unspecified number of patients of unknown age and gender. No concurrent conditions or medical history were reported. On 10-SEP-2015, unspecified patients were vaccinated with unspecified doses of improperly stored PNEUMOVAX 23 (Lot # K008409 Expiration date: 04-MAR-2016) (dose, route and anatomical location of administration were not reported). No concomitant therapy was provided. No adverse effects were reported. No Product Quality Complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
patient had 2 episodes of seizure-like activity, second episode lasting 20 minutes.  patient went to ER and had full sepsis workup over 4 days, CSF, urine, and blood cx negative at 48 hours.  patient still continuously febrile after 5 days. Patient was transferred to our facility for continuing care, with neurology and infectious disease specialists consulted.  8/21/09 MR received for DOS 7/21-23/09 with dx: Sepsis under evaluation. Pt presented with fever, seizures, irritability. T'=103.1 despite anti-pyretics. Began with upper extremity jerking and pallor which resolved.  Later had episode of whole body shaking, unresponsiveness, vomiting and diaphoresis. Admitted with dx: Seizure, R/O Meningitis. R/O Bacteremioa. Transferred to higher level of care on 7/23/09.  9/21/09 Hospital records received DOS 7/23/09 to 7/26/09. Assessment: Aseptic Meningitis. Patient transferred from another facility with history of seizure. Arm began to shake, then entire body, unresponsive and staring. Vomiting. Fever.   ICD-9 Codes: 038.9 Septicemia NOS, 047.9 Viral Meningitis NOS.
Fatigue, headache, muscle aches, fever, chills.  Lasted right at 24 hours.  Involved resting and sleeping for about 16 hours during that time.
Gave undiluted vaccine to patient. Did not realize second bottle in bag was diluent until after vaccine was administered. Notified team lead of event, who in turn notified the chief as well as patient. Through recommendation, patient was asked to stay a total of 45 minutes instead of the usual 15 minutes. Patient has no history of vaccine reactions based on vaccine pre-assessment sheet. No symptoms throughout 45 minutes of wait time. Patient was provided water during wait. Initially assessed for any signs of reaction; given instructions to notify staff if he experienced any emergent symptoms. He remained stable throughout the wait. He was notified if he experienced severe muscle aches in the next 48 hours, he can forego second dose in series, and that event is recorded in incident report in facility. Recommended patient to call nurse advice line if he experienced symptoms in the next 48 hours after vaccination.
fever a week after first shot; headache a week after first shot; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever a week after first shot) and HEADACHE (headache a week after first shot) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    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 PYREXIA (fever a week after first shot) and HEADACHE (headache a week after first shot). At the time of the report, PYREXIA (fever a week after first shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No Concomitant information  provided. No Treatment information  provided
patient was only given the liquid portion (DTaP-IPV component) of Pentacel and the powdered component (ActHIB vaccine) was not given, no adverse event; Initial information was received on 19-Jun-2020 regarding an unsolicited valid non-serious case from the other healthcare professional.  This case involves a five month old female patient who was vaccinated with a 0.5 ml second dose of vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ315AA and expiration date 03-Apr-2021) via an intramuscular route in the left thigh on 05-Jun-2020 for prophylactic vaccination.  The patient's medical history, medical treatment, vaccination and family history were not provided.  The patient's concomitant vaccinations included PNEUMOCOCCAL VACCINE and ROTAVIRUS VACCINE received on an unknown date for prophylactic vaccination.  It was an actual medication error case due to active ingredient not added to diluent (product preparation error) as the patient was only given the liquid portion (Dtap-Ipv component) of pentacel and the powdered component (ACTHIB vaccine) was not given.  No adverse event occurred following immunisation.  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 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.
I contracted COVID-19 on 12/16/2021 with symptoms of fever of 101 for 2 to 3 days, cough, scratchy throat, runny nose, congestion, chest congestion. I felt better within a week although my lingering cough continued. My cough became a wheezing cough that my doctor prescribed a Symbicort inhaler for me to continue to use until the lingering wheezing cough resolved. I went in for my normal checkup in February or March of 2022 and my doctor ordered a chest x-ray that came back normal. I am still experiencing the lingering cough and wheezing; although the Symbicort inhaler is managing it fairly well for me. I received my Moderna dose 3 COVID-19 15 days after my bout of COVID-19.
Left upper arm swollen and red and warm to touch (localized cellulitis), afebrile.