chrisvoncsefalvay/vaers-outcomes huggingface dataset:
Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge; No adverse event; 40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005c21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 31-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored), PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (40 patients received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored) and PRODUCT STORAGE ERROR (Patient received the moderna monovalent vaccines (1st & 2nd doses) after being more than 30 days stored in the fridge).    Concomitant product use was not provider by the reporter.  The vaccines were stored in the fridge on 30-Jun-2021. Best used date was reported as 30-Jul-2021. Doses were administered between 02-Aug-2021 and 20-Sep-2021. Patient did not report any side effects.  Treatment information was not provided. This case included information for patient 23 out of 31.   This case was linked to US-MODERNATX, INC.-MOD-2023-698994.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-698994:Master case
Sharp,  stabbing pain in chest. Difficulty breathing deeply due to pain. Woke up from the pain. Lasted approximately 4 hours.
This case was reported by a pharmacist via call center representative and described the occurrence of chills in a 55-year-old male patient who received SHINGRIX for prophylaxis. On 27th February 2018, the patient received the 1st dose of SHINGRIX  (intramuscular). On 27th February 2018, less than a day after receiving SHINGRIX , the patient experienced chills, night sweats and fever. On an unknown date, the outcome of the chills, night sweats and fever were recovered/resolved. The reporter considered the chills, night sweats and fever to be related to SHINGRIX. Additional details were provided as follows: The patient received the SHINGRIX vaccine at around 1:00 PM in the left arm. The same day, at night, the patient experienced fever, chills, and night sweats which resolved that night. The suspect vaccine lot number and expiry date was not available. For tolerance after the 2nd dose of SHINGRIX, refer case US2018GSK111482. This case is one of the 5 cases, reported by the same reporter.
some of the dose did not go into the patient's arm and leaked out, no AE; Initial information regarding an unsolicited valid non-serious case was received from pharmacist (Reference number- 00715961) and transmitted on 09-Aug-2021.  This case involves a 54-year-old female patient who received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] from which some of the dose did not go into the patient's arm and leaked out (underdose).  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  On 09-Aug-2021, the patient received 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ686AA and expiry date: 30-Jun-2022) via an intramuscular route in the arm for prophylactic vaccination from which some of the dose did not go into the patient's arm and leaked out (underdose).  It was reported that "Pharmacist wanted to know what the protocol should be."  This was a case of actual medication error due to vaccine underdose (latency same day).  At time of reporting, no adverse events were reported.  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.
Suspected Vaccination Failure; had the shingles shot and got it anyway; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by the consumer for himself/herself. The age at vaccination was not reported. The reporter stated that, he/she had the Shingles shot and got shingles anyway. This case was considered as suspected vaccination failure, since the details regarding the completion of primary vaccination schedule, time to onset for event and laboratory confirmation for shingles were not provided.
1/7/2021: Struggled with major fatigue, severe chills, and body ache during the day, left arm moderate pain, and a temperature of 100.8 measured in the afternoon. 1/8/2021, Severe headache early in the morning throughout the day, almost immobilizing. Moderate left arm pain. 1/9/2021: Mild headache, moderate to mild left arm pain. 1/10/2021: Mild left arm pain. Most symptoms were alleviated with Tylenol and Motrin.
Chest tightness, throat felt like it was closing, throat itching/sore, dizziness.
Information has been received from a licensed practical nurse concerning a 55 year old female patient with allergic to aspirin, statins, NIACIN and REMERON who on 15-OCT-2009 was vaccinated IM in the right deltoid with 'one dose" of PNEUMOVAX 23. Concomitant therapy included FOSAMAX, SPIRIVA, hydrocodone, VALTREX and LOVAZA. On 16-OCT-2009 the patient experienced redness, heat, and swelling at the injection site. The patient sought unspecified medical attention. No lab diagnostic study was performed. On unspecified date, the patient recovered. Additional information has been requested.
stuffy nose; flu-like symptoms; headache; muscle ache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASAL CONGESTION (non-serious), outcome "recovered", described as "stuffy nose"; INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "flu-like symptoms"; HEADACHE (non-serious), outcome "recovered"; MYALGIA (non-serious), outcome "recovered", described as "muscle ache".  Additional information: With vaccine, patient ended up showing flu-like symptoms (headache, muscle ache, stuffy nose, etcetera) within 24 hours of receiving the vaccine. The symptoms went away within a day.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received. Sender's Comments: Linked Report(s): PFIZER INC-202201363305 same patient/event, different vaccine dose number; PFIZER INC-202201363306 same patient/event, different vaccine dose number;
arm pain; Fever; vomiting; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain), PYREXIA (Fever), VOMITING (vomiting) and NAUSEA (nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm pain), PYREXIA (Fever), VOMITING (vomiting) and NAUSEA (nausea). At the time of the report, PAIN IN EXTREMITY (arm pain), PYREXIA (Fever), VOMITING (vomiting) and NAUSEA (nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.5.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.; Sender'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.
Pt complained of deltoid region with 5" diameter "tenderness" with daily "stinging" like pain. No redness, no nodule, no warmth or edema. Also, pt complained of shooting pain "sciatic nerve" pain radiating left from hip to foot, a few weeks after Anthrax vax. Leg pain, weakness without limp until walking 15-20 steps.
Fever: 0100AM Chills: 0100AM - Temp 103.6 oral; Taken to ER at 0230. While in ER was given; Two bags of IV fluids. Motrin 400mg and Zofram 2mg
While standing, patient felt faint and almost collapsed. Patient then sat down. Patient reported increased heart rate and dizziness,. Blood pressure was elevated when checked via manual blood pressure. She was given water and advised to remain seated. Advised to go to the hospital, but patient refused. Patient was then observed for 20min. After 20min, patient reported a decrease in symptoms and was able to stand on her own. Before leaving, patient's blood pressure was checked again manually. Second manual blood pressure check revealed a decrease in previously high blood pressure.
Fever, NauseaVomiting, CHILLS, INJECTION SITE PAIN AND SWELLING Narrative:
The patient received a dose of the vaccine following temperature excursions on unknown dates; No adverse event; This spontaneous report as received from a medical assistant refers to a current 1-year-old patient of unknown gender.  The patient's concurrent conditions, medical history and concomitant medications were not provided.   On an unknown date, the rotavirus vaccine, live, oral, pentavalent (ROTATEQ)  (lot # S013439 with expiration date 03-MAR-2021, lot # S013436 with expiration date 30-JAN-2021, and lot # S006050 with expiration date 12-DEC-2020) underwent a temperature excursion.   Temperature Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) Time frame 7 hours 30 minutes Previous temperature excursion? yes, Total Time and LOWEST Temperature BELOW 36°F/2°C (0C) for 8 hours 30 minutes Was call because of a "data logger"? yes  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) at a dose of 2 ml (route not provided) as prophylaxis. No adverse events were reported.  This is one of several reports received from the same reporter  This spontaneous report as received from a other health professional refers to a patient of unknown age.    On an unknown date the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # S006050, 2 milliliter for prophylaxis.       On an unknown date the patient experienced product storage error and no adverse event.    The outcome of product storage error and no adverse event is unknown.   The reporter considered product storage error and no adverse event to be not assessed to Rotavirus Vaccine, Live, Oral, Pentavalent(ROTATEQ).     {Additional information has been requested. / Additional information is not expected.}; Sender's Comments:  US-009507513-2005USA003382: US-009507513-2005USA004950: US-009507513-2005USA004951: US-009507513-2005USA004952: US-009507513-2005USA004953: US-009507513-2005USA004954: US-009507513-2005USA004955: US-009507513-2005USA004956: US-009507513-2005USA004957: US-009507513-2005USA004958: US-009507513-2005USA004959: US-009507513-2005USA004960: US-009507513-2005USA004961: US-009507513-2005USA004962: US-009507513-2005USA004963: US-009507513-2005USA004964: US-009507513-2005USA004965: US-009507513-2005USA004966: US-009507513-2005USA004967: US-009507513-2005USA004968: US-009507513-2005USA004969: US-009507513-2005USA004970: US-009507513-2005USA004971: US-009507513-2005USA004972: US-009507513-2005USA004973: US-009507513-2005USA004974: US-009507513-2005USA004975: US-009507513-2005USA004976: US-009507513-2005USA004977: US-009507513-2005USA004978: US-009507513-2005USA004979: US-009507513-2005USA004980: US-009507513-2005USA004981: US-009507513-2005USA004982: US-009507513-2005USA004983: US-009507513-2005USA004984: US-009507513-2005USA004985: US-009507513-2005USA004986: US-009507513-2005USA004987: US-009507513-2005USA004988: US-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
Vaccines administered after being in stored in fridge past 30 days; Patient that received first dose of primary series of Moderna Bivalent vaccine; Vaccines administered after being in stored in fridge past 30 days; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event) in an 81-year-old patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine), PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccines administered after being in stored in fridge past 30 days), WRONG PRODUCT ADMINISTERED (Patient that received first dose of primary series of Moderna Bivalent vaccine) and PRODUCT STORAGE ERROR (Vaccines administered after being in stored in fridge past 30 days).    No concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-730541 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-730541:same reporter
Patient was given HPV vaccine.  Within a few minutes, parent came out of room and advised that child was not responsive.  When provider and staff entered room,  patient was listless.  911 was called. Pt was sent to Hospital and transferred to Medical Center.
Narrative: COVID infection following COVID vaccine series 05/03 Janssen, dose #1 (non-Facility) 08/01 pt cc: cough, headache, sore throat, nasal congestion, headache, exposure: unknown 08/06/ COVID swab, result: detected 08/12 SARS-COV-2 LINEAGE B.1.617.2 08/12 SARS-COV-2 CLADE 21A DELTA
more than 42 days for administration of second dose; patient younger than 18 years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient younger than 18 years of age) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose) in a 12-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient younger than 18 years of age). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose). In June 2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (patient younger than 18 years of age) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (more than 42 days for administration of second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. No treatment drug details was reported.
pt has a large red warm swollen rash travelling down arm below injection site- pt also has felt feverish but not running a fever
started on 8/12/21, cough (productive); diarrhea, fever 101.7
41/2 months after receiving the vaccine I began having chronic dizziness. After seeing Dr. I was told that a virus had "killed"/attacked my acoustic nerve in my left ear. I did not have a cold, flu or other conditions at the time of the vaccine or at the onset of the dizziness. I have had the dizziness for 41/2 years everyday. I have been treated with medication, antihistamines, physical therapy and acu puncture.
States received Pfizer Bivalent Booster on 9/19/2022, for several days noticed (L) arm was sore with some redness and inflammation to area of site. Then on 9/21/2022 woke up around 0400 with arm numbness and tingling sensation that radiated down (L) arm into fingers and palm of hand and felt as if were unable to grasp/grip anything or open/close hand properly, patient felt was due to possibly slept wrong and went back to sleep.  Patient then woke up around 0630 and states some of the numbness/tingling had subsided but continued to have numbness to (L) ring/pinky fingers and palm of hand, denies any type of slurred speech or any other symptoms that occurred with this event.  She reported to the unit at 0900 with the complaints, observation by RN is slight inflammation and slight erythema at site, no swelling or abnormalities to the any other part of the (L) arm, appears as a local adverse reaction as could be a potential from any other vaccination.   Instructed to have further evaluation by PCP for possible other health related issues and contact after evaluation with outcome.  Does not have any slurred speech
Dose administered >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017f21a) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Dec-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Dec-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture). On 07-Dec-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication information was reported. No Treatment medications were provided.
pt recvd vax; Lt arm became sore & swollen 20oct94 more than expected; swollen upper arm; taken to ER; ER said nothing to be done; warm to the touch & red also;  when went to ER 22oct94 sxs have now resolved;
ADULT OBSTRUCTIVE SLEEP APNEA, MILD ACUTE HYPOXEMIC RESPIRATORY FAILURE HYPOXIA
I don't feel so good; This is a spontaneous report from a non-contactable consumer, the patient. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unknown date as a single dose for COVID-19 vaccination. Medical history was unknown. The patient's concomitant medications were not reported. On an unknown date, the patient reported "I don't feel so good and I don't want to go to the hospital." The clinical outcome of " don't feel so good" was unknown.    No follow-up attempts are possible. Information on the lot/batch number cannot be obtained.
lymph nodes are swollen; headaches; nausea; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (lymph nodes are swollen), HEADACHE (headaches) and NAUSEA (nausea) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph nodes are swollen), HEADACHE (headaches) and NAUSEA (nausea). At the time of the report, LYMPHADENOPATHY (lymph nodes are swollen) had not resolved and HEADACHE (headaches) and NAUSEA (nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided by the reporter Concomitant medications were not provided. Patient race included.
Severe pain and limited motion in in left arm following tetanus shot. Arm could not be extended above head from 12/31 until 1/8. This resulted in another visit to clinic on 1/7. At this time a medrol dose pack and ultrasound therapy were administered. Symtoms were alleviated on 1/8/10.