chrisvoncsefalvay/vaers-outcomes huggingface dataset:
7 m onth old male patient received expired dose o f PENTACEL vaccine, no AE; Initial information received on 23-Jul-2021 regarding an unsolicited non-valid non-serious case from a other health professional via physician(Reference number- 00694713).  This case involves a 7 month old male patient who was vaccinated with the expired dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included ROTAVIRUS VACCINE LIVE ORAL 1V (ROTARIX) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE CONJ (PNEUMOCOCCAL CONJUGATE VACCINE) for Prophylactic vaccination.  On 24-Jun-2021, the patient received a 0.5 ml second dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ342AAA and expiry date: 22-Jun-2021) (Frequency: once) via an  intramuscular route in the left vastus lateralis (expired product administered) for prophylactic vaccination.  It was an actual medication error case due to expired vaccine used (latency on same day).  At the time of reporting, no adverse event was reported.   It was reported that "patient Information patient age lees than one year enter as 2 month, 4month, etc. Many pediatric vaccines need month for age. Dose 0.25 mL to 2 mL for vaccines or 0.1 mL for TB (Tuberculosis) skin test-0.5ML, Strength standard for Fluzone HD-STANDARD. Pregnancy-not applicable, Last menstrual period, due date, AE (adverse event) symptoms or no AE, If baby was delivered: delivery date and if baby experienced an adverse event, Inform that they will be receiving a follow up questionnaire, If calling specifically about being added to the pregnancy registry: all pregnancy cases are added to the registry, it is an FDA (food drug administration) requirement".  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.
1.5hr-2hr after MMR given. Client complained of chills with fever ranging from 101-104 degrees. Fever of 101 on 7/28 when called. Did not see MD.
Headaches, my teeth ached, stomach upset, soreness at injection site, my skin hurt.
20-30 erythematous papules on trunk. Non-pruritic, pt nontoxic, no oral lesions, pt contacted Beale AFB last night - will follow up there 5/8/03.
Temp; Bad headache; My arm is sore; This case was reported by a consumer via interactive digital media and described the occurrence of pyrexia in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th November 2022, the patient received the 2nd dose of Shingrix. On 11th November 2022, less than a day after receiving Shingrix, the patient experienced pyrexia, headache and pain in arm. On an unknown date, the outcome of the pyrexia, headache and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the pyrexia, headache and pain in arm to be related to Shingrix.     Additional Information: GSK receipt date: 11-Nov-2022 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the second dose of Shingrix on the day of reporting. The patient experienced temp, bad headache and arm sore. The patient was asking if we could take Motrin for any side effect. Note: Motrin was not coded as no confirmation if patient taken medication or not. Additional Supportive Information: The follow up would not possible, as no contact, details were available.
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 6-month-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-009507513-2005USA004545: 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-009507513-2005USA004989: US-009507513-2005USA004990: US-009507513-2005USA004991: US-009507513-2005USA004992: US-009507513-2005USA004993:
Pt c/o nausea reported to EMT AT 1507. EMT reported to RN's on site. Pt offered adult dose of diphenhydramine. Pt denied diphenhydramine. Pt denied difficulty swallowing, unlabored breathing, denies throat pain, denies any chronic illnesses. Pt advised to wait an extra 15 minutes for further observation. Pt symptoms subsided. Pt left vaccination site at 1523 with a steady gait.
Elevated heart rate, fever over 101.0, sweating, severe shivering, headache, sleeplessness, weakness, and nausea.
Patient called and stated that after receiving vaccinations (FLUAD and PNEUMOVAX 23), she had to be hospitalized approx. 7 hours later due to "inability to stand up". She stated that the doctors were unable to determine the cause.
Adverse side effect- acute watery diarrhea, persistent  for over 3 days- and subsequent dehydration.
Passed out; She dropped; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (Passed out) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 048A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     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 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced LOSS OF CONSCIOUSNESS (Passed out) (seriousness criterion medically significant) and FALL (She dropped). At the time of the report, LOSS OF CONSCIOUSNESS (Passed out) and FALL (She dropped) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Apr-2021, Blood pressure measurement: low (Low) very low.         Concomitant medication swere not reported.  No treatment information was reported. The patient reported that the ambulance came and went to emergency room, a nd was admitted in the hospital for 3 hours. The patient had no other diseases, and was crying and asking for help about her bills, because she had no insurance and needed help.; 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.
Onset of soreness at injection site immediately following vaccination for 2 days.  Then soreness continued after the 2 days from her elbow up to her shoulder and is worse at rest. Tylenol helps relieve discomfort. No redness or swelling or tingling to extremity.
Hair loss; This case was reported by a pharmacist via call center representative and described the occurrence of hair loss in a adult male patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B at an unknown dose. On an unknown date, unknown after receiving Engerix B, the patient experienced hair loss. On an unknown date, the outcome of the hair loss was unknown.   It was unknown if the reporter considered the hair loss to be related to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced hair loss after receiving Engerix-B.  No additional details were provided. The pharmacist stated that the vaccination was not given at his pharmacy. This case has been linked to the case US2019094083, reported by same reporter for the same patient.
Patient states left arm was   swollen,    itching , and                                           hot to touch at site of injection.  This started 1 week after vaccination.
At 9:15 am I started to get sweats and chills and feel week.  9:30 started to notice throat was swelling.  9:45 am I reported to the nurse because throat was swelling to point I had no voice and felt weak.  I was given Benedryl and sat down.  My pulse was taken and blood pressure was taken.  My pulse was high and so was blood pressure.  I felt weak and dizzy.  Pulse and blood pressure remained high.   After Benedryl and 30 minutes, the swelling started to go down in throat and voice returned.  Pulse and blood pressure started to go down also. After 3 weeks I felt normal.  The weakness and dizziness, sore throat from the swelling and the blood pressure were finally back to normal.
short of breath; felt so weak; injection site she has sorta red around it and itchy; injection site "sorta red around it"; joint pain; headache; muscle pain; really bad chills; very fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (short of breath), ASTHENIA (felt so weak), VACCINATION SITE PRURITUS (injection site she has sorta red around it and itchy), CHILLS (really bad chills) and FATIGUE (very fatigue) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CHILLS (really bad chills), FATIGUE (very fatigue), ARTHRALGIA (joint pain), HEADACHE (headache) and MYALGIA (muscle pain). On 17-Jan-2021, the patient experienced ASTHENIA (felt so weak), VACCINATION SITE PRURITUS (injection site she has sorta red around it and itchy) and VACCINATION SITE ERYTHEMA (injection site "sorta red around it"). On 19-Jan-2021, the patient experienced DYSPNOEA (short of breath). On 17-Jan-2021, ARTHRALGIA (joint pain) and MYALGIA (muscle pain) had resolved. On 18-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, DYSPNOEA (short of breath), ASTHENIA (felt so weak), VACCINATION SITE PRURITUS (injection site she has sorta red around it and itchy), CHILLS (really bad chills), FATIGUE (very fatigue) and VACCINATION SITE ERYTHEMA (injection site "sorta red around it") outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication details was not reported by the reporter. Treatment included Tylenol.
Received expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired vaccine). On 07-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Received expired vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Treatment information was not provided.  The patient had no symptoms after administration. No temperature excursion episodes, vial was stored correctly.   This case was linked to MOD-2021-311017 (Patient Link).
Pain in arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at the vaccination was not reported. The case was reported by the reporter for the pharmacist. The patient received Shingrix and experienced arm pain.  No details about the patients was available at time of report. The reporter did not consent to follow up. This case linked with US2020AMR084981, US2020084176 and US2020AMR084982, reported by same reporter.
TOOK VIVOTIF THAT WAS IN A 50 DEGREE FAHRENHEIT REFRIGERATOR; This spontaneous case report (PVX2019-1969) was received from a caregiver on 30-Jul-2019. It described a 15-year-old adolescent female consumer who reported "took Vivotif that was stored out of range" (PT: Product storage error). The consumer was receiving Vivotif (lot number: 3003278) for an unknown indication.  Case report: A caregiver reported that they had kept Vivotif in a refrigerator at 46 degree Fahrenheit before leaving on a vacation.  When they returned after 10-11 days, the refrigerator was at 50 degree Fahrenheit. The Vivotif was exposed to 50 degree Fahrenheit for about 10 days.  On 30-Jul-2019, her daughter took the first dose of Vivotif.  Action taken with Vivotif was not applicable.  The clinical outcome of the event was unknown.  Company's Comment: The causality of the event "took Vivotif that was stored out of range" was considered as not applicable.; Sender's Comments: Company's Comment: The causality of the event "took Vivotif that was stored out of range" was considered as not applicable.
Patient presented to pharmacy (two days after the vaccine was administered) with complaints of redness at injection site, lack of appetite, chills and night sweats. Patient has not taken anything for treatment.
shortness of breath; 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 DYSPNOEA (shortness of breath) 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 (No adverse events were reported).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, DYSPNOEA (shortness of breath) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter did not allow further contact
1120: Drooling, Rt side facial drooping, BP: 60/30; 911 contacted; became unresponsive on toliet; shallow deep breathing; transferred to Wheelchair; EMS arrived and transferred to ED; In hospital cause of death listed Cardiac Pulmonary Arrest; Date of death 1/17/21
Had COVID Disease 3 months after 2nd Monovalent Booster; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Had COVID Disease 3 months after 2nd Monovalent Booster) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 29-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2022, the patient experienced COVID-19 (Had COVID Disease 3 months after 2nd Monovalent Booster). The patient was treated with MONOCLONAL ANTIBODY 17-1A for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (Had COVID Disease 3 months after 2nd Monovalent Booster) outcome was unknown.     No Concomitant medication was reported. Patient had had COVID and received Monoclonal antibody 3 months ago. Reporter did not allow further contact
Started to feel itchy all over body without hives within 15 minutes. Then started to feel as if her tongue was swollen but did not appear to be so within 30 minutes of administration. Shortly thereafter patient complained of lump in throat, we administered one EpiPen and called 911
IM injection of Engerix B - Glaxo Smith Kline - Lot # AHBVB845AA - Exp date 06/15/2012 - drove home after injection - felt fine - layed down - about 6:30PN, four hours after injection got up and felt weakness and parathesis in arms and legs - difficulty walking - had relative bring her to the ER - they treated her with fluids which helped but did not cure the symptoms.
Information in severe pain in legs and arms weakness and numbness in right arm and hand left thumb and forefinger weakness numbness left foot numb right foot weak on the right side. Had cervical myelopathy surgery due to inflammation emergency surgery. That did not resolve the problem the next 4 months I'm trying to find the doctors stabilize and by now the spinal cord is so inflamed that I've got this disease and every single vertebrate pain is unbelievable excruciating. I have no balance in coordination I have to use a mobility scooter now cuz I can barely walk everything falls straight through my hands and they keep looking at my spine as the problem whereas before I have the vaccine I was in perfect health.  Parsonage Turner syndrome sounds like what happened to me.
IPV given right deltoid IM. Small bandaid applied. Child developed small blisters at site. Had elevated temp to 102.7 at night on Tues (7/8/03). 7/13: 101.3. 7/14 - temp 98.3.
Student was given Tdap, Menactra and HPV. The HPV was the last to be administered. His whole body became stiff/clamped and lost consciousness for less than a minute (about 40 seconds). A little diaphoretic after the episode.
Fever 101 plus for 48 hours after onset. Headache, body aches, coughing etc...
77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.; Product storage error; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) in an adult 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. AS7140C) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.), PRODUCT STORAGE ERROR (Product storage error) and NO ADVERSE EVENT (No adverse event) outcome was unknown. Not Provided      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (77 patients received Moderna bivalent booster doses that had undergone a temperature excursion.) and PRODUCT STORAGE ERROR (Product storage error).    No concomitant medication was provided by reporter.  It was reported as 77 patients received Moderna bivalent booster doses that had undergone a temperature excursion. The doses were administered before it was known if the vaccine was ok to use after the excursion.  No treatment medication was provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-696122 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-696122:Master case