chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Feb-2022 at 1:01 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 06-Feb-2022 at 1:01 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) and PRODUCT STORAGE ERROR (Received vaccine past its 30-days Exp date Vaccines went into 2-8 C thaw state on or about 24-Dec-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Date and time of vaccine administered provided as 06-FEB-2022 13:01:12. Patient received booster dose. The patient received Moderna vaccine past its 30 day of expiry date. Vaccine went into 2 to 8 degree Celsius thaw state on or about 24-Dec-2021. This vaccine was administered up until its manufacturing expiry date of 04-Apr-2022 and they no longer possess this lot number.  No treatment medications were reported.
patient received FLUBLOK that was under the age of 18 with no reported adverse event; Initial information received  on 22-Mar-2022 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 16 years old male patient who received flublok that was under the age of 18 with no reported adverse event while receiving vaccine influenza quadrivalent recombinant vaccine [Flublok QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Mar-2022, the patient received a dose of suspect influenza quadrivalent recombinant vaccine 0.5 ml Single-dose prefilled syringe at a dose of 0.5 ml total once (lot : QFAA2126; expiry date: 30-Jun-2022) via intramuscular route in the left deltoid for Immunization.  On 01-MAR-2022, the patient received influenza quadrivalent recombinant vaccine that was under the age of 18 with no reported adverse event (off label use) (latency: same day).  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event.
Patient received Nasal H1N1 vaccine Mon 11/2. Reports 6 hrs later developed cough and fever at time of visit on 11/4/09 (2d later) T 99.9 rest of physical. No distress mild nasal congestion.
Urticaria present on abdomen about 1 1/2 hrs after receiving today's vaccines. No shortness of breath. No skin reaction at site of immunizations symptoms improved s/p BENADRYL.
4-20-07 Mother called stating "Patient had a bad case of chickenpox. I called doctor. He prescribed Benadryl. She has spots all over her face, hands, arms she's covered. No fever."
Muscle pain, limiting L arm ROM, soreness  Pt seen 12/3/21 given Methylprednisolone and advised to take Ibuprofen, pt declined xray, and advised if not better in 3-4 days to make a follow up visit.
Tingly from head to toe; Short of breath; Chest is like tight; Pains in intestine; Tired; Headache; This spontaneous case was reported by a patient and describes the occurrence of PARAESTHESIA (Tingly from head to toe), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest is like tight), GASTROINTESTINAL PAIN (Pains in intestine), FATIGUE (Tired) and HEADACHE (Headache) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced PARAESTHESIA (Tingly from head to toe) (seriousness criterion medically significant), DYSPNOEA (Short of breath) (seriousness criterion medically significant), CHEST DISCOMFORT (Chest is like tight) (seriousness criterion medically significant), GASTROINTESTINAL PAIN (Pains in intestine) (seriousness criterion medically significant), FATIGUE (Tired) (seriousness criterion medically significant) and HEADACHE (Headache) (seriousness criterion medically significant). At the time of the report, PARAESTHESIA (Tingly from head to toe), DYSPNOEA (Short of breath), CHEST DISCOMFORT (Chest is like tight), GASTROINTESTINAL PAIN (Pains in intestine), FATIGUE (Tired) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Side effects started after 20 minutes of receiving the shot. Patient went to the hospital. Patient stated that she was sleeping well and drinking lots of water.  Concomitant product use was not provided by the reporter.  Treatment for the event included ibuprofen.  Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Caller reported vaccine administered after temperature excursion; This spontaneous report was received from a medical assistance referring to a patient of unknown age and gender. Relevant medical history, drug reactions/allergies and concomitant medication for the patient involved were not reported.  On 04-NOV-2022, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live(PROQUAD) rHa, 0.5 ml, subcutaneously, lot number: W004026 (expiration date: 02-AUG-2023) for prophylaxis.   The storage characteristics were the following: - Temperature -11.7C - Time frame 6 hours and 17 minutes - Previous temperature excursion? No  No adverse effects were reported.; Sender's Comments:  US-009507513-2211USA002447:
This spontaneous report was received from a nurse practitioner (N.P.) concerning a 17 year old female patient. The patient had no pertinent concurrent conditions, medical history or drug reactions. On 20-AUG-2015, the patient was vaccinated with the first dose of GARDASIL 9 as well as a dose of MENACTRA both in the left deltoid (dose, Lot No. and route of administration were not reported). Concomitant medications included unspecified topical acne medication. The patient called the office and complained of a "grade size mass" in the left deltoid which appear in approximately 2015 on an unknown day. No laboratory diagnostics were conducted. The patient would visit the office on 15-SEP-2015, reported as "today" for an assessment. The outcome of injection site mass was unknown. This is one of several reports received from the same source. Additional information has been requested.
pt recvd vax & exp t103 gave APAP advised cold baths-called about 4PM advised to give another dose of APAP & recheck temp; to ER if temp not dec, pt to ER t103
This spontaneous report as received from a registered nurse refers to a 4 month old patient. The patient's concurrent conditions, medical history and drug allergies were not reported. On 19-DEC-2016, the patient was vaccinated with improperly stored ROTATEQ, oral, (dose not reported) from lot # M007311 (expiry date: unspecified) for prophylaxis. Concomitant medications were not reported. The vaccine was exposed to a temperature of 34.5 Fahrenheit for 100 minutes. Data logger was involved. There were no previous excursions. No adverse events were reported. Product quality complaint was not involved. This is one of the several reports received from the same reporter. Additional information is not expected as all correspondence has been received. Follow-up information indicated that suspect product with the lot# M007311 had not actually involved in the previously reported temperature excursion. Therefore, case # 1612USA012714 is being deleted from our files on generic rotavirus vaccine, live, oral, pentavalent. This is an amended report, as corrected. The reference type for the E2B number US-009507513-1610USA014706 has been changed from E2B Company Number to E2B Linked Report.; Sender's Comments: US-009507513-1610USA008140: US-009507513-1610USA014705: US-009507513-1610USA014706:
I started having fever cough sneezing, and chest congestion it lasted for two days and days three I got tested. I started having headaches and it was causing nausea upon calling my doctor and getting a positive test I was prescribed something for nausea. During the next four days I started to improve.
Statement of Incident:  A partially used vial of Moderna was returned to the refrigerator instead of being discarded on 30 Dec 2020.  On 4 Jan 2021, the partially used vial was used to vaccinate at least six patients. On 5 Jan 2021, the Immunizations Team was discussing wasted vaccines and was reminded of the 6 hour expiration timeframe once a vial is punctured.  One of the members realized that they used the above mentioned open vial on 4 Jan 2021 well beyond the 6 hour timeframe. In addition, once a vial is punctured and brought to room temperature, placing the vial back into the refrigerator will invalidate the vial and make it unusable.  Mission Impact: A minimum of six patients received invalidated vaccine. Consultation with program concurred the doses given from this vial should be considered invalid and recommend that all patients who received vaccine from this vial be revaccinated. Corrective Action Required/Taken: The clinic, Medical Staff and the office were notified to report the patient safety error.  The team identified ten patients who did or possible did receive the invalid vaccine.  After consulting with AFMRA Risk Management, the NCR Market Healthcare Resolution Specialist and program, all ten patients were contacted, received full disclosures, and were recommended to receive repeat Dose 1 as soon as possible.  Eight patients were revaccinated on 6 Jan 2021.  Two declined revaccination and plan to get Dose 2 as previously scheduled.  A Concise Incident Analysis (mini- Root Cause Analysis) is being conducted to determine root causes and ensure effective process improvements are implemented.  Note: this patient was one of two who declined a second dose.
Information has been received from a registered nurse (hematology case manager) concerning a 14 year old male with sickle cell anaemia who on 01-JUN-2006 was vaccinated subcutaneously with a dose of Pneumovax 23. Subsequently, on 02-JUN-2006, the patient developed pain, redness and swelling from the shoulder to the elbow. The child was referred to a hospital emergency department. At the time of this report, the outcome of the events was unknown. Additional information has been requested.
Patient noticed a tender lymph node at her left clavicle the morning after her flu vaccination. She saw her doctor.  The doctor was uncertain whether or not the tender node was related to the vaccination.
expired vaccine given to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041J21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients). On 29-Dec-2021, EXPIRED PRODUCT ADMINISTERED (expired vaccine given to patients) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication use was reported.   This case was linked to MOD-2021-435992.
Next day post vax, the pt developed swelling at injection site. Symptoms progressed to include itching, more swelling at injection site, peripheral paresthesias in injection arm, myalgias, headaches, tinnitus. No dyspnea or throat discomfort. No other rashes. Naprosyn initiated but unhelpful. Treated with prednisone and Allegra.
Patient presented with on 5/12/21 with headache, nausea and vomiting, malaise, and decreased responsiveness. Headache and malaise had been present on/off since late April after patient had received the second dose of Moderna COVID-19 vaccine. Head CT in ED revealed venous sinus thrombosis. MR venogram with near complete occlusion of the superior sagittal sinus, right transverse and sigmoid sinuses, right internal jugular vein), possible mastoiditis on the right side. Started on heparin drip, unasyn, and transferred to neurosurgical ICU. 5/13/21 underwent mechanical thrombectomy; of the superior sagittal sinus, bilateral transverse and sigmoid sinuses and the right vein of Labbe  - flow has been restored. Partial clots remained in right internal jugular vein. Heparin drip was changed to antiXa goal 0.3-0.7. HNS consult - no strong evidence of mastoiditis. 5/14/21 repeat MRI/MRV - thrombus within the right transverse sinus, sigmoid sinus and right jugular bulb, no thrombi in the dominant left transverse sinus or SSS - anticoagulation was changed from heparin to enoxaparin 1 mg/kg every 12 hours 5/15/21 patient was observed in the ICU  5/16/21 discharged home in stable condition
Seen on 10/11 with widespread rash on body starting 1 week after influenza injection; rash itchy, bleeding on buttocks from scratching. Diagnosis: Gianotti-Crosti syndrome. Parent reassurance: may take 8-12 weeks to resolve.
Slight chills, increasing chills & hot flashes, severe chills, high fever, loss of orientation, obscure(?) cramps, 14 hrs later fever, less chills, woke every 30-45 mins. Heavy sweating.
No fever. 30 Eruptions-Chicken Pox like "heads: had been scratched off. Exam otherwise normal.
bloody nose; spit from his mouth and there was blood; This is a spontaneous report from a contactable consumer (wife). A 67-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL8982), via an injection in the left arm on 20Jan2021 at 14:00 (at the age of 67-years-old) as a single dose for Covid-19 immunization. Medical history included diabetic from 2009 and unknown if ongoing. The patient had not had any other recent vaccinations or new medications. Concomitant medications included clopidogrel bisulfate (PLAVIX) from an unknown date (taken for about 10 years) at 75mg daily for blood thinner. On 21Jan2021, the patient experienced bloody nose and he spit from his mouth and there was blood. Reporter stated that the blood was coming from his nose and dripping out. No treatment was given for the events. The clinical outcome of the epistaxis was not recovered; for mouth hemorrhage was unknown.
I am sure they gave me every vaccine under the sun.  I suffered a severe swelling in my lymph node, under the arm at which was my injection site for the smallpox vaccines, which was just a day after my vaccine. I could not even put my arms down to my side, it was so swollen. I went to clinic to have it looked at, but the Clinic stated that they were not concerned and did not even do anything except look at swelling. No Tests were performed.  I still suffer from mysterious 'pockets' of unknown material and origin under my skin, primarily across my abdominal area. Once again, Medical was largely unconcerned with even assessing the ailments.
Persistent leg pain; Persistent muscle pain; 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 PAIN IN EXTREMITY (Persistent leg pain) and MYALGIA (Persistent muscle pain) in a patient of an unknown age and gender 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Persistent leg pain) and MYALGIA (Persistent muscle pain). At the time of the report, PAIN IN EXTREMITY (Persistent leg pain) and MYALGIA (Persistent muscle pain) outcome was unknown.            Concomitant medications were not reported  Treatment medication information was not provided
reaction to MENINGOCOCCAL MCV4P  - influenza vaccine placed on other arm and no swelling noted                   - soft ball size swelling  - wide as his arm  - 3 inches diameter  - swelling is not sticking out but arm is hot  - feels hot to the touch
This spontaneous report was received from a nurse refers to a patient of unknown age and gender. medical history was not reported. The nurse informed that on 25-JUN-2014 the patient was vaccinated with M-M-R II (strength, doses and route were not reported) lot number: J008728, expiration date: 26-JUL-2015. That may had been improperly exposed since February 2014. The thermometer battery ran out in February 2014, so the refrigerator temperature was not able to be confirmed to be within recommended storage temperature since then. The highest temperature the M-M-R II could had been exposed was 70F. Also stated that was no way to determine what the exact temperature was at any given time after 01-FEB-2014 since the battery in the thermometer stopped working. No adverse effects reported. This is one of several reports received from the same reporter. Additional information has been requested.
A report has been received from a Pharmacist concerning a 50 year old, female subject, who had been receiving FLUMIST Intranasal) FLUMIST (Intranasal) started on an unknown date. It was reported by the pharmacist that on 17-Oct-2013, they administered FLUMIST to the patient who is 50 years old. The patient did not experience any adverse symptoms. The outcome of the event of INADVERTENTLY ADMINISTERED FLUMIST is unknown. The report was considered to be non-serious by reporter. Summary of insignificant follow-up information received by AstraZeneca/MedImmune on 27-Feb-2014 from pharmacist: Start date for the suspect product FLUMIST added. Form completed date updated. Narrative updated. Corrected report on 20-Apr-2014: Patient initials added. Event onset date added. Reporter information corrected. Positive rechallenge, dechallenge information corrected.
This spontaneous report as received from a nurse practitioner refers to a 38 days old patient. The patient was vaccinated with the first dose of PEDVAXIB (Lot # not reported) on 09-JAN-2013 "too soon". No symptoms were reported. Additional information has been requested.
Vomiting, diarrhea, severe abdominal cramps, bad headache, low grade fever(99°), muscle and joint pain.
I have a rash that looks like shingles but does not itch or burn. There is an ache in the muscle in the shoulder opposite where I received the vaccine.  This did not begin until 7 days after I received the vaccine
At 07:30 patient approached this writer and stated he was feeling lightheaded and sweaty and felt as though she may faint.  This writer instructed her to sit down.  This writer then requested assistance from RN.  As RN approached where patient was sitting, patient stated "yeah I'm going to faint" she then fell forward from her chair onto the floor, with the top of her head hitting the floor first.  RN instructed staff to call the Rapid Response Team who was unavailable.  This writer gathered the anaphylaxis/reaction supplies that were on hand.  Patient's body postured and at that time RN rolled her onto her side.  Patient quickly regained consciousness.  Vitals were taken and stable. Patient was given the opportunity to be seen in the ED multiple times but she declined.   She stated that her lips felt "tingly" and was given 50mg/20mL Diphenhydramine oral solution.  She remained in the COVID vaccination clinic at Medical Center for observation for 40 minutes, at which time her husband retrieved her and escorted her home.
Information has been received on 16-JAN-2018 regarding a case in litigation from a lawyer and a female consumer of unknown age. The patient's concurrent conditions, medical history and concomitant medications are unknown. On or about 03-JUN-2014, the patient was inoculated with ZOSTAVAX (lot number and expiration unknown) subcutaneous, as recommended for routine adult health maintenance and for the prevention of shingles. The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 23-MAR-2015, the patient was treated for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient has been prescribed valacyclovir hydrochloride (VALTREX) and prednisone for management of her painful condition. 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. Additional information has been requested.
Pharmacy error: The Moderna vaccine batch/lot #003C21A sent on 11/24/2021 to our clinic should have the absolute expiration date of 12/17/2021, not 12/24/2021.