chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: RSV, RSV
Symptoms: Tinnitus, Tremor, Vertigo, Vomiting
Clinical narrative: The injection site had peeled and healed with scar; The injection site had peeled and healed with scar; Redness and swelling turned into blister/burn and rash; Redness and swelling turned into blister/burn and rash; Redness and swelling turned into blister/burn and rash; Redness and swelling turned into blister/burn and rash; rash/still have a rash on my body; This non-serious case was reported by a consumer and described the occurrence of injection site exfoliation in a 61-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 79T9F) for prophylaxis.   On 05-DEC-2023, the patient received Arexvy. On 07-DEC-2023, 2 days after receiving Arexvy, the patient experienced erythema (Verbatim: Redness and swelling turned into blister/burn and rash), swelling (Verbatim: Redness and swelling turned into blister/burn and rash), blister (Verbatim: Redness and swelling turned into blister/burn and rash), burn (Verbatim: Redness and swelling turned into blister/burn and rash) and rash (Verbatim: rash/still have a rash on my body). On an unknown date, the patient experienced injection site exfoliation (Verbatim: The injection site had peeled and healed with scar) and injection site scar (Verbatim: The injection site had peeled and healed with scar). The outcome of the injection site exfoliation was resolved and the outcome of the injection site scar was not reported and the outcome of the erythema, swelling, blister, burn and rash were not resolved.   It was unknown if the reporter considered the injection site exfoliation, injection site scar, erythema, swelling, blister, burn and rash to be related to Arexvy.     It was unknown if the company considered the injection site exfoliation, injection site scar, erythema, swelling, blister, burn and rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 05-JAN-2024 The patient reported that she had received Arexvy vial 10pk kit and had redness and swelling and its turned into the blister, burn and rash. The patient visited primary care physician and received cream for rash over, but the doctor said needed it to work its way through her system.  The injection site had peeled and healed with a scar, but she still have a rash on her body. The patient reported that the symptoms were treated. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Incorrect dose administered, Myalgia, Somnolence
Clinical narrative: Muscle soreness; Tired all the time; Drug overdose; Sleepiness; Headache dull; This non-serious case was reported by a consumer and described the occurrence of sleepiness in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number 47P9H) for prophylaxis.   Concurrent medical conditions included arrhythmia, bronchial asthma, hypothyroidism, osteoarthritis, depression, gout, gastroesophageal reflux disease, diuretic therapy, electrolyte replacement and allergy. Concomitant products included flecainide, bisoprolol, fluticasone furoate, vilanterol trifenatate (Breo Ellipta), levothyroxine sodium (Levothroid), celecoxib, escitalopram, montelukast, pantoprazole, torsemide and potassium.   On 09-JAN-2024, the patient received Shingrix 1 ml. On 09-JAN-2024, 141 days after receiving Shingrix, the patient experienced sleepiness (Verbatim: Sleepiness), headache dull (Verbatim: Headache dull), tired all the time (Verbatim: Tired all the time) and drug overdose (Verbatim: Drug overdose). On an unknown date, the patient experienced myalgia (Verbatim: Muscle soreness). The outcome of the sleepiness, headache dull, tired all the time and drug overdose were not resolved and the outcome of the myalgia was not reported.   It was unknown if the reporter considered the sleepiness, headache dull, myalgia, tired all the time and drug overdose to be related to Shingrix.     It was unknown if the company considered the sleepiness, headache dull, myalgia, tired all the time and drug overdose to be related to Shingrix.   Additional Information: GSK Receipt date: 10-JAN-2024 The reporter was a patient. The reporter expected some side effects with her second dose was supposed to be 0.5ml and she was given 1 ml, which led to overdose. Patient was wondering what to expect. Dose was given by pharmacist. The all symptoms were not treated. Patient received Allupurinol for gout. The reporter requested to consent to follow-up.
Sex: M
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient was given Bexsero instead of Engerix B (which is for Hep B); This non-serious case was reported by a other health professional via patient support programs and described the occurrence of wrong vaccine administered in a 47-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   On 11-JAN-2024, the patient received Bexsero. On 11-JAN-2024, an unknown time after receiving Bexsero, the patient experienced wrong vaccine administered (Verbatim: Patient was given Bexsero instead of Engerix B (which is for Hep B)). The outcome of the wrong vaccine administered was unknown.   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: 11-JAN-2024 This report was submitted via the online direct entry reporting system.  The reporter stated that the patient was given Bexsero instead of Engerix B (which is for Hep B) and wanted to know if there would be any side effects.  The reporter consented to follow up. The patient received Bexsero instead of Engerix-B, which led to wrong vaccine administered.
Sex: U
Vaccine: RSV
Symptoms: Injection site discolouration, Injection site pain, Pruritus
Clinical narrative: arm itch; Sight back and blue; Very little pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of itchy upper limbs in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 7 days after receiving Arexvy, the patient experienced itchy upper limbs (Verbatim: arm itch), skin discoloration (Verbatim: Sight back and blue) and pain (Verbatim: Very little pain). The outcome of the itchy upper limbs and pain were not reported and the outcome of the skin discoloration was not resolved.   It was unknown if the reporter considered the itchy upper limbs, skin discoloration and pain to be related to Arexvy.     It was unknown if the company considered the itchy upper limbs, skin discoloration and pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 06-JAN-2024 The reporter stated that the arm itch so bad 7 days after RSV shot. The sight was still back and blue and very little pain.
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: administered an unapproved vaccine while pregnant; I was administered an unapproved vaccine while pregnant; Arexvy administered to 33 years old patient; This non-serious prospective pregnancy case was reported by a consumer via interactive digital media and described the occurrence of vaccine exposure during pregnancy in a 33-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced vaccine exposure during pregnancy (Verbatim: administered an unapproved vaccine while pregnant), wrong vaccine administered (Verbatim: I was administered an unapproved vaccine while pregnant) and inappropriate age at vaccine administration (Verbatim: Arexvy administered to 33 years old patient). The outcome of the vaccine exposure during pregnancy, wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 09-JAN-2024 This case was reported by consumer via interactive digital media. The patient was 36 weeks and 3 days pregnant. The patient was happy to saw the Abrysvo RSV vaccine was now approved for pregnant women up to 36 weeks. The patient got prescription from her doctor and brought it into a pharmacy. The patient verbally confirmed with the pharmacy technician that she would be receiving Abrysvo and they confirmed as yes. After the pharmacist administered the shot to patient, she looked on his desk and saw the box said Arexvy, which led to wrong vaccine administered. Now Arexvy had not been approved in pregnant women. The current formulation (an adjuvanted version) was not ever tested in pregnant women. The had a clinical trial of an unadjuvanted version that was ended early due to possible increased risk of preterm birth. Reporter did not know what needs to be done. The patient asked question that if their any trial was for the unadjuvanted version, it was possible that she was the only pregnant woman ever to receive the adjuvanted Arexvy RSV vaccine. The patient asked question that how concerned she should be. The patient below than the recommended age limit received Arexvy vaccine, which led to inappropriate age at vaccine administration. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: fever and muscle aches; fever and muscle aches; This non-serious case was reported by a consumer via call center representative and described the occurrence of fever in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, less than a day after receiving Shingrix, the patient experienced fever (Verbatim: fever and muscle aches) and muscle pain (Verbatim: fever and muscle aches). The outcome of the fever and muscle pain were resolved (duration 1 day).   It was unknown if the reporter considered the fever and muscle pain to be related to Shingrix.     It was unknown if the company considered the fever and muscle pain to be related to Shingrix.   Additional Information: GSK Receipt date: 08-JAN-2024 The reporter was a patient. Reporter reported that he received the Shingrix vaccine about 18 months ago, in unknown arm. Reporter reported that he felt feverish and had muscle aches the day he received vaccine. Reporter reported that the symptoms resolved the next day of vaccination. The reporter did not consent to follow-up. For tolerance of 2nd dose refer case US2024003317, reported by same reporter.; Sender's Comments:  US-GSK-US2024003317:2nd dose case
Sex: F
Vaccine: VARZOS
Symptoms: Exposure via skin contact, Injection site discharge, Underdose
Clinical narrative: dose leaked out of arm; patient felt like the dose of Shingrix leaked out of her arm after administration; patient felt like the dose of Shingrix leaked out of her arm after administration; patient felt like the dose of Shingrix leaked out of her arm after administration; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site leaking in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site leaking (Verbatim: dose leaked out of arm), inadvertent exposure to vaccine (Verbatim: patient felt like the dose of Shingrix leaked out of her arm after administration), exposure via skin contact (Verbatim: patient felt like the dose of Shingrix leaked out of her arm after administration) and incomplete dose administered (Verbatim: patient felt like the dose of Shingrix leaked out of her arm after administration). The outcome of the injection site leaking, inadvertent exposure to vaccine, exposure via skin contact and incomplete dose administered were unknown.   It was unknown if the reporter considered the injection site leaking to be related to Shingrix.     It was unknown if the company considered the injection site leaking to be related to Shingrix.   Additional Information: GSK receipt date: 05-JAN-2024 The pharmacist reported a patient felt like the dose of Shingrix leaked out of her arm after administration, which led to inadvertent exposure to vaccine, exposure via skin contact and incomplete dose administered. The reporter did not had any patient demographics, lot number, or expiration date to provide. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The patient received his second dose of Shingrix late; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingrix) (batch number LC757, expiry date 21-AUG-2024) for prophylaxis.   Previously administered products included shingrix (received first dose on 22nd October 2020).   On 06-NOV-2023, the patient received the 2nd dose of Shingrix. On 06-NOV-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: The patient received his second dose of Shingrix late). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 08-JAN-2024 The registered Pharmacist reported that a patient received his second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. The patient's doctor of medicine was telling him to ignore the first dose and get another dose. The reporter consented to follow up. This case had been link with US2024003324, reported by the same reporter.; Sender's Comments:  US-GSK-US2024003324:Same reporter, 2nd patient
Age: 8.0
Sex: M
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: 5 days after the expiration date; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 8-year-old male patient who received HBV (Engerix B) (batch number 77X47, expiry date 22-DEC-2023) for prophylaxis.   On 27-DEC-2023, the patient received Engerix B. On 27-DEC-2023, an unknown time after receiving Engerix B, the patient experienced expired vaccine used (Verbatim: 5 days after the expiration date). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 09-JAN-2024 The reporter reported that a patient received expired Engerix-B, which led to expired vaccine used. The reporter consented to follow up via email.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Doctor administered to this patient a Shingrix possible second late dose; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 54-year-old male patient who received Herpes zoster (Shingrix) (batch number CR5XF, expiry date 23-AUG-2025) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix in 2019).   On 13-OCT-2023, the patient received the 2nd dose of Shingrix. On 13-OCT-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Doctor administered to this patient a Shingrix possible second late dose). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 09-JAN-2024. The doctor had a not immunocompromised patient who believes that Shingrix first dose occurred on 2019, even though the doctor did not agree with this. The doctor administered to this patient a Shingrix possible second late dose, which led to lengthening of the vaccination schedule. No further information about possible Shingrix first dose from 2019 was available.  The reporter consented to follow up
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus
Clinical narrative: patient has itching at the injection site and around the injection site area of her left arm; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 87-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-NOV-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injection site itching (Verbatim: patient has itching at the injection site and around the injection site area of her left arm). The outcome of the injection site itching was not resolved.   It was unknown if the reporter considered the injection site itching to be related to Shingrix.     It was unknown if the company considered the injection site itching to be related to Shingrix.   Additional Information: GSK Receipt Date: 09-Jan-2024 The reporter was the daughter of the patient. The reporter reported that the patient received Shingrix vaccine and experienced itching at the injection site and around the injection site area of her left arm.  The reporter stated that the itching comes and goes and gets worse at night and the patient still had this itching today. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Device connection issue, Exposure via skin contact, Syringe issue, Underdose
Clinical narrative: the needle was not screwed on all the way so most of the vaccine leaked down the patient's arm. She estimates the patient received less than half of the vaccine; the needle was not screwed on all the way so most of the vaccine leaked down the patient's arm.; the needle was not screwed on all the way so most of the vaccine leaked down the patient's arm.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number C5M4M, expiry date 30-SEP-2025) for prophylaxis.   On 10-JAN-2024, the patient received the 2nd dose of Shingrix. On 10-JAN-2024, an unknown time after receiving Shingrix, the patient experienced accidental underdose (Verbatim: the needle was not screwed on all the way so most of the vaccine leaked down the patient's arm. She estimates the patient received less than half of the vaccine), inadvertent exposure to vaccine (Verbatim: the needle was not screwed on all the way so most of the vaccine leaked down the patient's arm.) and exposure via skin contact (Verbatim: the needle was not screwed on all the way so most of the vaccine leaked down the patient's arm.). The outcome of the accidental underdose, inadvertent exposure to vaccine and exposure via skin contact were unknown.   Additional Information: GSK Receipt Date: 10-JAN-2024 The pharmacist reported that the patient had administered a dose of Shingrix patient on 10Jan2024, but the needle was not screwed on all the way so most of the vaccine leaked down the patient's arm, which led to accidental underdose, inadvertent exposure to vaccine and exposure via skin contact. The reported that she estimated the patient received less than half of the vaccine. The pharmacist reported that the patient's second dose in the series.  The reported that at the time of reporting, the dose has not been repeated.  The reporter consented to follow up.  The reported that the Vaccine administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination failure; patient had received Shingrix but had a  (mild) shingles episode a year later; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected Vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: patient had received Shingrix but had a  (mild) shingles episode a year later). 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 Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 09-JAN-2024 The reporter was physician. The reporter asked that if patient had received Shingrix but had a (mild) shingles episode a year later, should they get revaccinated with shingrix. What was the data on patients that had shingles after Shingrix and does they have multiple shingles outbreaks. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: U
Vaccine: HEP
Symptoms: Underdose
Clinical narrative: An adult patient received a half dose of Engerix-B today.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a adult patient who received HBV (Engerix B) for prophylaxis.   On 10-JAN-2024, the patient received Engerix B. On 10-JAN-2024, an unknown time after receiving Engerix B, the patient experienced underdose (Verbatim: An adult patient received a half dose of Engerix-B today.). The outcome of the underdose was unknown.   Additional Information: GSK Receipt Date: 10-Jan-2024 The reporter reported that the patient received a half dose of Engerix-B which led to underdose. The reporter declined to provide any more details. The reporter did not consent to follow up.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Malaise, Myalgia, Pyrexia
Clinical narrative: Mild malaise/ feeling sick and no interference with activity; Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement); Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Moderate muscle pain with some interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/ feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Moderate muscle pain with some interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/ feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Moderate muscle pain with some interference with activity). At the time of the report, MALAISE (Mild malaise/ feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Moderate muscle pain with some interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: Mild fever (100.4 to 101.2 Degree F).         No concomitant medication was reported.   Patient had experienced malaise, vaccination site pain, pyrexia, fatigue and myalgia anytime during the 2 days after COVID-19 vaccination, which occurred on Saturday, 16 Dec 2023 and Sunday, 17 Dec 2023.       No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Patient 5
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild malaise/ feeling sick and no interference with activity; Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement); Mild fever (100.4 to 101.2 °F); Mild fatigue and no interference with activity; Moderate muscle pain with some interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Mild malaise/ feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Moderate muscle pain with some interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Mild malaise/ feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Moderate muscle pain with some interference with activity). At the time of the report, MALAISE (Mild malaise/ feeling sick and no interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/ Moderate injection site tenderness (tenderness with movement)), PYREXIA (Mild fever (100.4 to 101.2 °F)), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Moderate muscle pain with some interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: Mild fever (100.4 to 101.2 Degree F).         No concomitant medication was reported.   Patient had experienced malaise, vaccination site pain, pyrexia, fatigue and myalgia anytime during the 2 days after COVID-19 vaccination, which occurred on Saturday, 16 Dec 2023 and Sunday, 17 Dec 2023.       No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Patient 5
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise, Myalgia, Vaccination site pain
Clinical narrative: Moderate malaise/feeling sick present with some interference with activity; Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Mild injection site swelling; Mild fatigue and no interference with activity; Moderate muscle pain with some interference with activity; Headache that interfered with activity OR required repeated use of a nonprescription pain reliever; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Moderate muscle pain with some interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) and HEADACHE (Headache that interfered with activity OR required repeated use of a nonprescription pain reliever). At the time of the report, MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) and HEADACHE (Headache that interfered with activity OR required repeated use of a nonprescription pain reliever) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication was not reported.  Patient had headache that interfered with activity OR required repeated use of a nonprescription pain reliever.  Treatment medication was not reported..  Patient experienced vaccination site pain, vaccination site swelling, Fatigue, Malaise, Myalgia, Headache events anytime during the 2 days after vaccination which occurred on 17-Dec-2023 and 18-Dec-2023.      This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Patient no 20
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Moderate malaise/feeling sick present with some interference with activity; Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Mild injection site swelling; Mild fatigue and no interference with activity; Moderate muscle pain with some interference with activity; Headache that interfered with activity OR required repeated use of a nonprescription pain reliever; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity) and MYALGIA (Moderate muscle pain with some interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) and HEADACHE (Headache that interfered with activity OR required repeated use of a nonprescription pain reliever). At the time of the report, MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), FATIGUE (Mild fatigue and no interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) and HEADACHE (Headache that interfered with activity OR required repeated use of a nonprescription pain reliever) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       Concomitant medication was not reported.  Patient had headache that interfered with activity OR required repeated use of a nonprescription pain reliever.  Treatment medication was not reported..  Patient experienced vaccination site pain, vaccination site swelling, Fatigue, Malaise, Myalgia, Headache events anytime during the 2 days after vaccination which occurred on 17-Dec-2023 and 18-Dec-2023.      This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Patient no 20
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Malaise, Myalgia
Clinical narrative: Moderate malaise/feeling sick present with some interference with activity; Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Mild injection site swelling; Mild fever (100.4 to 101.2 degree F); Moderate fatigue with some interference with activity; Moderate muscle pain with some interference with activity; Joint pain with some interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 degree F)) and FATIGUE (Moderate fatigue with some interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 degree F)), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) and ARTHRALGIA (Joint pain with some interference with activity). At the time of the report, MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 degree F)), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) and ARTHRALGIA (Joint pain with some interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: Mild fever (100.4 to 101.2 degree F).           Concomitant medication was not reported.  Patient experienced Malaise, Vaccination site pain, Vaccination site swelling, Pyrexia, Fatigue, Myalgia, Arthralgia events anytime during the 2 days after vaccination which occurred on 18-Dec-2023 and 19-Dec-2023.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Master case
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain, Vaccination site swelling
Clinical narrative: Moderate malaise/feeling sick present with some interference with activity; Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch); Mild injection site swelling; Mild fever (100.4 to 101.2 degree F); Moderate fatigue with some interference with activity; Moderate muscle pain with some interference with activity; Joint pain with some interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 degree F)) and FATIGUE (Moderate fatigue with some interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 degree F)), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) and ARTHRALGIA (Joint pain with some interference with activity). At the time of the report, MALAISE (Moderate malaise/feeling sick present with some interference with activity), VACCINATION SITE PAIN (Moderate injection site pain interfering with activity/Mild injection site tenderness (tender to touch)), VACCINATION SITE SWELLING (Mild injection site swelling), PYREXIA (Mild fever (100.4 to 101.2 degree F)), FATIGUE (Moderate fatigue with some interference with activity), MYALGIA (Moderate muscle pain with some interference with activity) and ARTHRALGIA (Joint pain with some interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: Mild fever (100.4 to 101.2 degree F).           Concomitant medication was not reported.  Patient experienced Malaise, Vaccination site pain, Vaccination site swelling, Pyrexia, Fatigue, Myalgia, Arthralgia events anytime during the 2 days after vaccination which occurred on 18-Dec-2023 and 19-Dec-2023.  Treatment medication was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-756177 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756177:Master case
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia, Vaccination site erythema
Clinical narrative: Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch); Mild injection site redness; Mild fever (100.4 to 101.2 degree F); Mild fatigue and no interference with activity; Headache and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), PYREXIA (Mild fever (100.4 to 101.2 degree F)), FATIGUE (Mild fatigue and no interference with activity) and HEADACHE (Headache and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), PYREXIA (Mild fever (100.4 to 101.2 degree F)), FATIGUE (Mild fatigue and no interference with activity) and HEADACHE (Headache and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), PYREXIA (Mild fever (100.4 to 101.2 degree F)), FATIGUE (Mild fatigue and no interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: Mild fever (100.4-to-101.2-degree F).         Concomitant medications were not reported.  The patient experienced events anytime during the 2 days after COVID-19 vaccination, which occurred on Tuesday, 19-Dec-2023 and Wednesday, 20-Dec-2023.  No treatment information was provided.      This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Same reporter (Patient 59 out of 87)
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch); Mild injection site redness; Mild fever (100.4 to 101.2 degree F); Mild fatigue and no interference with activity; Headache and no interference with activity; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), PYREXIA (Mild fever (100.4 to 101.2 degree F)), FATIGUE (Mild fatigue and no interference with activity) and HEADACHE (Headache and no interference with activity) in a patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In December 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In December 2023, the patient experienced VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), PYREXIA (Mild fever (100.4 to 101.2 degree F)), FATIGUE (Mild fatigue and no interference with activity) and HEADACHE (Headache and no interference with activity). At the time of the report, VACCINATION SITE PAIN (Mild injection site pain and no interference with activity/ Mild injection site tenderness (tender to touch)), VACCINATION SITE ERYTHEMA (Mild injection site redness), PYREXIA (Mild fever (100.4 to 101.2 degree F)), FATIGUE (Mild fatigue and no interference with activity) and HEADACHE (Headache and no interference with activity) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2023, Body temperature: Mild fever (100.4-to-101.2-degree F).         Concomitant medications were not reported.  The patient experienced events anytime during the 2 days after COVID-19 vaccination, which occurred on Tuesday, 19-Dec-2023 and Wednesday, 20-Dec-2023.  No treatment information was provided.      This case was linked to US-MODERNATX, INC.-MOD-2024-756099 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-756099:Same reporter (Patient 59 out of 87)
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, SARS-CoV-2 test
Clinical narrative: Lower energy level for about a month after; Felt tired for a day or two but no fever or arm soreness ever; This spontaneous case was reported by a non-health professional and describes the occurrence of ASTHENIA (Lower energy level for about a month after) and FATIGUE (Felt tired for a day or two but no fever or arm soreness ever) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch nos. 037F21A, 022M204 and 029L20A) for COVID-19 prophylaxis.     The patient's past medical history included Breast cancer (Lumpectomy of right breast) from 26-Aug-2014 to 19-Nov-2022 and Lumpectomy (Lumpectomy of right breast) on 06-May-2015. Concurrent medical conditions included Hypothyroidism since 2017. Concomitant products included LEVOTHYROXINE from 01-Nov-2017 to an unknown date for Hypothyroidism.   On 20-Jan-2021, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular use) 1 dosage form. On 17-Feb-2021, received second dose of mRNA-1273 (Spikevax) (Intramuscular use) dosage was changed to 1 dosage form. On 03-Nov-2021, received third dose of mRNA-1273 (Spikevax) (Intramuscular use) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA (Lower energy level for about a month after) and FATIGUE (Felt tired for a day or two but no fever or arm soreness ever). At the time of the report, ASTHENIA (Lower energy level for about a month after) outcome was unknown and FATIGUE (Felt tired for a day or two but no fever or arm soreness ever) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Nov-2023, SARS-CoV-2 test: Positive. On 19-Nov-2023, SARS-CoV-2 test: Negative. On 23-Nov-2023, SARS-CoV-2 test: Positive. On 26-Nov-2023, SARS-CoV-2 test: Positive. On 28-Nov-2023, SARS-CoV-2 test: Positive. On 30-Nov-2023, SARS-CoV-2 test: Negative. On 01-Dec-2023, SARS-CoV-2 test: Negative.         Treatment information was not provided.  On 13-Sep-2022, the patient received fourth dose from Pfizer bivalent vaccine. Lot no: GJ2524, left deltoid.  The patient received paxlovid for rebound covid-19 symptoms. The patient had ongoing sinus symptoms and prescribed with amoxiclav 875/125 on 28-Nov-2023.