chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Insomnia, Nausea, Pain, Vaccination site pain
Clinical narrative: Felt immense pain as fluid was injected; hit a nerve or injured the cartilage surrounding the humerus and went into the radial, and ulnar and stopped/Discomfort remained fixed in the right chest, and the pain in the shoulder; Unable to sleep longer than 2 hours; Nausea; hot watering mouth; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An 80-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 03Nov2023 as dose 1, single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Heart Disease" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: METOPROLOL, start date: 03Jul2015; LEVOTHYROXINE, start date: 03Jul2015; ALLOPURINOL, start date: 03Jul2015; FERROUS SULFATE, start date: 03Jul2015; SPIRONOLACTON, start date: 03Jul2015. Vaccination history included: bnt162b2 (DOSE 1), administration date: 29Aug2019, for COVID-19 immunization; bnt162b2 (DOSE 2), administration date: 20Aug2020, for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER)), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 03Nov2023 at 13:30, outcome "recovering", described as "Felt immense pain as fluid was injected"; NAUSEA (non-serious) with onset 03Nov2023 at 13:30, outcome "recovering"; INSOMNIA (non-serious) with onset 03Nov2023 at 13:30, outcome "recovering", described as "Unable to sleep longer than 2 hours"; PAIN (non-serious) with onset 03Nov2023 at 13:30, outcome "recovering", described as "hit a nerve or injured the cartilage surrounding the humerus and went into the radial, and ulnar and stopped/Discomfort remained fixed in the right chest, and the pain in the shoulder"; BURNING SENSATION (non-serious) with onset 03Nov2023 at 13:30, outcome "recovering", described as "hot watering mouth". Therapeutic measures were taken as a result of vaccination site pain, pain, insomnia, nausea, burning sensation. Additional information: there was no redness at the injection site. The patient felt "immense pain as fluid was injected, like it hit a nerve or injured the cartilage surrounding the humerus and went into the radial, and ulnar and stopped." The patient was unable to sleep longer than two hours, and it progressively worsened. The patient also experienced nausea, hot watering mouth, and pain from the injection site radiating from the right arm to the back area through upper scapula and around to the right upper chest area. Discomfort remained fixed in the right chest, and the pain in the shoulder was subdued with "500mg x 2, per four hours." Tylenol relieved the pain, and the patient felt more comfortable.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscle spasms
Clinical narrative: muscle cramps through-out my body, arms, stomach, thigh, back fingers, etc; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE SPASMS (muscle cramps through-out my body, arms, stomach, thigh, back fingers, etc) in a 64-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058877) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 04-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced MUSCLE SPASMS (muscle cramps through-out my body, arms, stomach, thigh, back fingers, etc). On 07-Nov-2023, MUSCLE SPASMS (muscle cramps through-out my body, arms, stomach, thigh, back fingers, etc) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.   It was unknown if the patient experienced any additional symptoms/events.
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: vertigo; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (vertigo) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Fall (she fell 3 weeks before.) and Concussion (needed some stitches, but she does not know if it is correlated to vertigo). Concomitant products included INFLUENZA VACCINE for an unknown indication.    On 07-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 08-Nov-2023, the patient experienced VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) had not resolved.            It was reported that patient received other vaccines in the 4 weeks prior to covid-10 vaccine.  Patient receives 1st dose of moderna covid-19 vaccine on 04-Feb-2021, 2nd dose on 04-Mar-2021, 3rd dose on 28-Apr-2021 and 4th dose on 07-Nov-2021.  It was reported that 24 hours after getting the vaccine, she started experiencing vertigo and this was still ongoing at the time of reporting.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-749082 (Linked Report). This case was linked to MOD-2023-749082 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749082:SPIKEVAX NOS case
Age: 68.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vertigo
Clinical narrative: vertigo; This spontaneous case was reported by a patient and describes the occurrence of VERTIGO (vertigo) in a 68-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included Fall (she fell 3 weeks before.) and Concussion (needed some stitches, but she does not know if it is correlated to vertigo). Concomitant products included INFLUENZA VACCINE for an unknown indication.    On 07-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 08-Nov-2023, the patient experienced VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) had not resolved.            It was reported that patient received other vaccines in the 4 weeks prior to covid-10 vaccine.  Patient receives 1st dose of moderna covid-19 vaccine on 04-Feb-2021, 2nd dose on 04-Mar-2021, 3rd dose on 28-Apr-2021 and 4th dose on 07-Nov-2021.  It was reported that 24 hours after getting the vaccine, she started experiencing vertigo and this was still ongoing at the time of reporting.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-749082 (Linked Report). This case was linked to MOD-2023-749082 (Patient Link).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749082:SPIKEVAX NOS case
Age: 73.0
Sex: F
Vaccine: COVID19-2, VARZOS, COVID19, VARZOS
Symptoms: Chills, Hallucination, Headache, Pyrexia, Vomiting
Clinical narrative: About 12 hours after vaccination patient experienced "chills, fever, headache and hallucination". Symptoms resolved "a few hours" after appearing and patient reports complete resolution of symptoms with no long-term effects.
Age: 73.0
Sex: F
Vaccine: COVID19-2, VARZOS, COVID19, VARZOS
Symptoms: Chills, Hallucination, Headache, Pyrexia
Clinical narrative: About 12 hours after vaccination patient experienced "chills, fever, headache and hallucination". Symptoms resolved "a few hours" after appearing and patient reports complete resolution of symptoms with no long-term effects.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Myocardial infarction, Pericarditis
Clinical narrative: Heart attack; Pericarditis; Stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Heart attack"; PERICARDITIS (medically significant), outcome "unknown"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "Stroke". The patient suffered heart attack, pericarditis and stroke too close to vaccine and stated it was not likely coincidence in healthy senior.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-PV202300185454 different patient, same drug and AEs;
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Myocardial infarction, Pericarditis
Clinical narrative: Heart attack; Pericarditis; stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID:.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: MYOCARDIAL INFARCTION (medically significant), outcome "unknown", described as "Heart attack"; PERICARDITIS (medically significant), outcome "unknown"; CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "stroke".  Clinical course: My family will never get another Covid shot. Husband and myself suffered heart attack, pericarditis and stroke too close to vaccines. Not likely coincidence in healthy seniors.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : UM-PFIZER INC-PV202300185453 Same drug and AE different patient;
Sex: F
Vaccine: MMRV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: no adverse event; HCP calling to report AE for patient that was given additional dose of PROQUAD instead of VAQTA.  Administered dose was on 10/13 but MNSC notified today.  Confirmed VAQTA not administered to patient, just PROQUAD.  No adverse reactions noted.  No add; HCP calling to report AE for patient that was given additional dose of PROQUAD.; This spontaneous report has been received from a nurse, referring to a 13-year-old female patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 13-OCT-2023, the patient received an additional dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) injection, single dose, lot #X009130, expiration date: 24-SEP-2024, administered for prophylaxis (strength, and route of administration were not provided) instead of hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (wrong product administered, extra dose administered).   It was confirmed that hepatitis a vaccine, inactivated (VAQTA)was not administered to patient, just measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) dose. No adverse reactions noted. No additional adverse events (No adverse event).
Sex: U
Vaccine: HIBV, PNC15
Symptoms: Product storage error
Clinical narrative: administered supported TE for PEDVAX HIB and VAXNEUVANCE; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported.  On 02-NOV-2023, the patient was vaccinated with improperly stored doses (product storage error) of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection, single dose, lot # reported and confirmed as: X002099, expiration date reported and confirmed as: 14-JUN-2025 (exact dose, site and route of administration were not provided); and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) in pre-filled syringe, single dose, lot # reported and confirmed as: X005583, expiration date reported and confirmed as: 10-DEC-2024 (exact dose, site and route of administration were not provided). Both vaccines were administered for prophylaxis by a health professional. Temperature excursion details: 33.9 degree Fahrenheit for 42 hours 5 minutes, no previous excursions.  This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2311USA002025:Associated AE Cases: 02503187 // 02503225
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; The nurse is reporting that a patient received improperly stored vaccine.  No additional AEs were reported, no further information provided.  Names of vaccines involved (including lot/exp) PROQUAD (x019553   1/19/2025) Temperature and Time frame: -9.; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 06-NOV-2023, the patient was vaccinated with 1 dose of an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (recombinant Human albumin) (PROQUAD) lot #X019553, expiration date: 19-JAN-2025 (exact dose, route of administration and anatomical location were not reported) for prophylaxis.   Administered dose of vaccine was exposed to the temperature excursion of -9.2 degrees Celsius for 7 minutes, and -11.2 degrees Celsius for 31 minutes (product storage error). No previous temperature excursion had occurred. There were no additional adverse events reported (no adverse event).  Lot number [X019553] has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD), therapy type rHA.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No other AE and no PQC; HBP calling to report an inadvertent administration of PROQUAD and VARIVAX to a patient on the same day.  HBP reporting a patient received both vaccines on 10/31/2023.  This was the first dose of both vaccines for this patient.; This spontaneous report has been received from a nurse, regarding a 12-month-old patient of unknown gender. The patient's pertinent medical history, previous drug reactions or allergies and concomitant medications were not reported.  On 31-OCT-2023, the patient was inadvertently vaccinated with the first dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) injection (lot number: W038809, which was determined to be valid, with an expiration date on 04-JUN-2024) and the first dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number: W031813, which was determined to be valid, with an expiration date on 05-OCT-2024), both as prophylaxis (strengths, doses, routes and anatomical locations of administration, lot numbers and expiration dates were not reported) (Accidental overdose).  No additional adverse event was provided.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Patient received 2 doses of Shingrix and was diagnosed with Shingles/suspected vaccination failure; Patient received 2 doses of Shingrix and was diagnosed with Shingles; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a male 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: Patient received 2 doses of Shingrix and was diagnosed with Shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Patient received 2 doses of Shingrix and was diagnosed with Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   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: 07-NOV-2023 The reported stated patient received 2 doses of Shingrix within appropriate time frame. The patient was diagnosed with shingles after completion of Shingrix vaccine. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Pain, Product preparation issue
Clinical narrative: Hip pain; body aches; administered x2 vials of liquid Arexvy adjuvant rather then one; administered x2 vials of liquid Arexvy adjuvant rather then one; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of pain in hip in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 31-OCT-2023, the patient received the 1st dose of Arexvy. On 31-OCT-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: administered x2 vials of liquid Arexvy adjuvant rather then one) and inappropriate dose of vaccine administered (Verbatim: administered x2 vials of liquid Arexvy adjuvant rather then one). On an unknown date, the patient experienced pain in hip (Verbatim: Hip pain) and general body pain (Verbatim: body aches). The outcome of the pain in hip and general body pain were not resolved and the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   The reporter considered the pain in hip and general body pain to be related to Arexvy.  The company considered the pain in hip and general body pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 03-NOV-2023 This report was submitted via the online direct entry reporting system.  The hip pain and body aches were reported as worsened. The patient was administered with two vials of liquid Arexvy adjuvant rather than x1 lyophilized powder reconstituted with x1 vial adjuvant, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The volume administered was more than 0.5 mL but the exact was unknown.  The reporter of ADE said no other adjuvanted vaccines were given recently.  No additional patient information was known. The reporter would get patient information and details would update when those were received.  The VAERS report might had already been submitted (unsure). This was not related to an existing case. The reporter consented to follow up.
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Malaise
Clinical narrative: General fatigue; feeling unwell; This non-serious case was reported by a consumer and described the occurrence of fatigability generalized in a 62-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy (unknown arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced fatigability generalized (Verbatim: General fatigue) and feeling unwell (Verbatim: feeling unwell). The outcome of the fatigability generalized and feeling unwell were resolved (duration 2 days).   The reporter considered the fatigability generalized to be related to Arexvy. It was unknown if the reporter considered the feeling unwell to be related to Arexvy.     The company considered the fatigability generalized to be related to Arexvy. It was unknown if the company considered the feeling unwell to be related to Arexvy.   Additional Information: GSK Receipt Date: 28-OCT-2023 The patient took first dose of Arexvy and experienced general fatigue and felt unwell for 1 to 2 days. Consumer reported seriousness for fatigue as not serious. Arexvy manufacturer, expiry date of Arexvy was unspecified. The reporter denied the consent to follow up.
Age: 87.0
Sex: F
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: patient who received an extra dose of Boostrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 87-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 7Z07L, expiry date 09-DEC-2023) for prophylaxis.   Previously administered products included boostrix (on 19th September 2023 received 1st dose.).   On 31-OCT-2023, the patient received the 2nd dose of Boostrix. On 31-OCT-2023, an unknown time after receiving Boostrix, the patient experienced extra dose administered (Verbatim: patient who received an extra dose of Boostrix). The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt date: 01-NOV-2023 An HCP requests data on potential adverse effects or risks to patient who received an extra dose of Boostrix which led to extra dose administered. The reporter Consented to follow up.
Age: 56.0
Sex: M
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 56 year-old patient received the Arexvy; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 56-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 01-NOV-2023, the patient received Arexvy (intramuscular). On 01-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: a 56 year-old patient received the Arexvy). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 03-NOV-2023 A pharmacist called to ask for information regarding the use of Arexvy in patients younger than 60 years of age.  The reporter reported that patient received the Arexvy vaccine and wanted to know if there was safety information concerning this situation. The reporter did not provide patient's initials nor information about the dose given (lot number, expiry date). The reporter consented to follow up. The patient received a dose of Arexvy at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate scheduling of vaccine/only had dose 1; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 15th May 2018). Concomitant products included fluticasone furoate + umeclidinium bromide + vilanterol trifenatate (Trelegy).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Inappropriate scheduling of vaccine/only had dose 1). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 03-NOV-2023 The patient called pharmacy and they said she only had dose 1 of Shingrix and referred her to call GlaxoSmithKline regarding dose 2. The reporter and her husband also took Trelegy and she wanted to find out about savings card, transferred to PA Team. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: RSV
Symptoms: Blister, Oral mucosal blistering
Clinical narrative: blisters on the mouth and fingertips; blisters on mouth; This non-serious case was reported by a physician via call center representative and described the occurrence of blister in a 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 blister (Verbatim: blisters on the mouth and fingertips) and blistering of mouth (Verbatim: blisters on mouth). The outcome of the blister and blistering of mouth were resolving.   It was unknown if the reporter considered the blister and blistering of mouth to be related to Arexvy.     It was unknown if the company considered the blister and blistering of mouth to be related to Arexvy.   Additional Information: GSK receipt date: 03-NOV-2023 The employee called on behalf of an HCP (MD).  The reporter reported that approximately 1 month ago, a patient received AREXVY. The 5 days later, the patient went to the HCP's office with blisters on the mouth and fingertips.  At the time of the call the blisters had subsided, and the HCP was still monitoring the patient.  The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: COVID19-2
Symptoms: Feeling abnormal, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient felt wiped out the next day but not as bad as the first two Moderna Covid-19 vaccine booster doses; I also had pain, redness, and a little swelling at the injection site; I also had pain, redness, and a little swelling at the injection site.; I also had pain, redness, and a little swelling at the injection site.; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Patient felt wiped out the next day but not as bad as the first two Moderna Covid-19 vaccine booster doses), INJECTION SITE PAIN (I also had pain, redness, and a little swelling at the injection site), INJECTION SITE ERYTHEMA (I also had pain, redness, and a little swelling at the injection site.) and INJECTION SITE SWELLING (I also had pain, redness, and a little swelling at the injection site.) in a 68-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7644C) for COVID-19 prophylaxis.     No Medical History information was reported.    On 20-Jul-2023, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In July 2023, the patient experienced INJECTION SITE PAIN (I also had pain, redness, and a little swelling at the injection site), INJECTION SITE ERYTHEMA (I also had pain, redness, and a little swelling at the injection site.) and INJECTION SITE SWELLING (I also had pain, redness, and a little swelling at the injection site.). On 21-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced FEELING ABNORMAL (Patient felt wiped out the next day but not as bad as the first two Moderna Covid-19 vaccine booster doses). At the time of the report, FEELING ABNORMAL (Patient felt wiped out the next day but not as bad as the first two Moderna Covid-19 vaccine booster doses), INJECTION SITE PAIN (I also had pain, redness, and a little swelling at the injection site), INJECTION SITE ERYTHEMA (I also had pain, redness, and a little swelling at the injection site.) and INJECTION SITE SWELLING (I also had pain, redness, and a little swelling at the injection site.) outcome was unknown.            Concomitant medication not reported.   Treatment medication not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748680, US-MODERNATX, INC.-MOD-2023-748686, US-MODERNATX, INC.-MOD-2023-748682 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: She reports that she received 6 previous Moderna COVID-19 vaccine and she had some side effects.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (She reports that she received 6 previous Moderna COVID-19 vaccine and she had some side effects.) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 030G22B and AS7165B) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 (had COVID Disease at the end of the year 2020.) in 2020.   On 13-Oct-2022, the patient received sixth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Mar-2023, received seventh dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (She reports that she received 6 previous Moderna COVID-19 vaccine and she had some side effects.). At the time of the report, IMMUNISATION REACTION (She reports that she received 6 previous Moderna COVID-19 vaccine and she had some side effects.) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. She reports that she received 6 previous Moderna COVID-19 vaccine and she had some side effects. But after receiving Spikevax she had such severe side effects that was worst than COVID disease that she had in 2020 prior to vaccination. Had side effects. worst than COVID Disease. She had  Flu shot on Aug 2023. No treatment medication reported.   This case was linked to MOD-2023-748689, MOD-2023-748694, MOD-2023-748694 (Patient Link).
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Illness, Palpitations
Clinical narrative: each time had gotten sick; had felt the palpitations; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (each time had gotten sick) and PALPITATIONS (had felt the palpitations) in a 37-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (each time had gotten sick) and PALPITATIONS (had felt the palpitations). At the time of the report, ILLNESS (each time had gotten sick) and PALPITATIONS (had felt the palpitations) outcome was unknown.            No concomitant medication was reported.  Patient had taken Moderna shots before and each time had gotten sick and had felt the palpitations.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-749030 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749030:Same patient, different dose
Age: 45.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Malaise, Vaccination site pain
Clinical narrative: General malaise; Injection site soreness; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (General malaise), VACCINATION SITE PAIN (Injection site soreness) and FATIGUE (Fatigue) in a 45-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 04-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 05-Nov-2023, the patient experienced MALAISE (General malaise), VACCINATION SITE PAIN (Injection site soreness) and FATIGUE (Fatigue). At the time of the report, MALAISE (General malaise), VACCINATION SITE PAIN (Injection site soreness) and FATIGUE (Fatigue) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Reported that all symptoms resolved within the following 24-48 hours. Patient was administered at a pharmacy without a treating physician. Treatment medication name was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-749069, US-MODERNATX, INC.-MOD-2023-749070, US-MODERNATX, INC.-MOD-2023-749071 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749069:Same Reporter US-MODERNATX, INC.-MOD-2023-749070:Same Reporter US-MODERNATX, INC.-MOD-2023-749071:Same Reporter
Age: 16.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Malaise, Vaccination site pain
Clinical narrative: general malaise; All experienced similar symptoms, primarily the next day, including injection site soreness; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (general malaise), VACCINATION SITE PAIN (All experienced similar symptoms, primarily the next day, including injection site soreness) and FATIGUE (fatigue) in a 16-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On 04-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 05-Nov-2023, the patient experienced MALAISE (general malaise), VACCINATION SITE PAIN (All experienced similar symptoms, primarily the next day, including injection site soreness) and FATIGUE (fatigue). At the time of the report, MALAISE (general malaise), VACCINATION SITE PAIN (All experienced similar symptoms, primarily the next day, including injection site soreness) and FATIGUE (fatigue) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  Patient was vaccinated with COVID booster 2023 on 04-Nov-2023 and received a Flu vaccine at the same time.    Primarily the next day experienced injection site soreness, fatigue and general malaise. All symptoms were resolved within the following 24-48 hours.  It was reported that administered at a pharmacy without a treating physician.  Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-749068, US-MODERNATX, INC.-MOD-2023-749070, US-MODERNATX, INC.-MOD-2023-749071 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749068:Same Reporter  US-MODERNATX, INC.-MOD-2023-749070:Same reporter  US-MODERNATX, INC.-MOD-2023-749071:Same reporter
Age: 13.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Malaise, Vaccination site pain
Clinical narrative: general malaise; All experienced similar symptoms, primarily the next day, including injection site soreness; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (general malaise), VACCINATION SITE PAIN (All experienced similar symptoms, primarily the next day, including injection site soreness) and FATIGUE (fatigue) in a 13-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On 04-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 05-Nov-2023, the patient experienced MALAISE (general malaise), VACCINATION SITE PAIN (All experienced similar symptoms, primarily the next day, including injection site soreness) and FATIGUE (fatigue). At the time of the report, MALAISE (general malaise), VACCINATION SITE PAIN (All experienced similar symptoms, primarily the next day, including injection site soreness) and FATIGUE (fatigue) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  Patient was vaccinated with COVID booster 2023 on 04-Nov-2023 and received a Flu vaccine at the same time.    Primarily the next day experienced injection site soreness, fatigue and general malaise. All symptoms were resolved within the following 24-48 hours.  It was reported that administered at a pharmacy without a treating physician.  Treatment medication use information was not provided by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-749068, US-MODERNATX, INC.-MOD-2023-749069, US-MODERNATX, INC.-MOD-2023-749071 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749068:Same Reporter  US-MODERNATX, INC.-MOD-2023-749069:Same reporter  US-MODERNATX, INC.-MOD-2023-749071:Same reporter
Age: 13.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Injection site pain, Malaise
Clinical narrative: general malaise; All experienced similar symptoms, primarily the next day, including injection site soreness; fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of MALAISE (general malaise), INJECTION SITE PAIN (All experienced similar symptoms, primarily the next day, including injection site soreness) and FATIGUE (fatigue) in a 13-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On 04-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 05-Nov-2023, the patient experienced MALAISE (general malaise), INJECTION SITE PAIN (All experienced similar symptoms, primarily the next day, including injection site soreness) and FATIGUE (fatigue). At the time of the report, MALAISE (general malaise), INJECTION SITE PAIN (All experienced similar symptoms, primarily the next day, including injection site soreness) and FATIGUE (fatigue) had resolved.      For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Patient was vaccinated COVID booster 2023 on 04-Nov-2023 and received a flu vaccine at the same time. Primarily the next day experienced injection site soreness, fatigue and general malaise. All symptoms resolved within the following 24-48 hours.  It was reported that administered at a pharmacy without a treating physician.   This case was linked to US-MODERNATX, INC.-MOD-2023-749068, US-MODERNATX, INC.-MOD-2023-749069, US-MODERNATX, INC.-MOD-2023-749070 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749068:Same Reporter  US-MODERNATX, INC.-MOD-2023-749069:Same reporter  US-MODERNATX, INC.-MOD-2023-749070:Same reporter
Age: 3.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: On 31Oct2023 she noticed that she had a welted red marks while she was in the tub; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (On 31Oct2023 she noticed that she had a welted red marks while she was in the tub) in a 3-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 14-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 31-Oct-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced URTICARIA (On 31Oct2023 she noticed that she had a welted red marks while she was in the tub). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and LEVOCETIRIZINE DIHYDROCHLORIDE (ALLEGRA [LEVOCETIRIZINE DIHYDROCHLORIDE]) at a dose of UNK, bid. At the time of the report, URTICARIA (On 31Oct2023 she noticed that she had a welted red marks while she was in the tub) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  On 31Oct2023 patient's mother noticed that patient had a welted red mark while she was in the tub. But reporter later noticed that they will disappear only to reappear in some other areas of patient's body - from her eyelids to the bottom of her feet and on her buns. Patient's mother gave her Benadryl initially but she noticed that there was no improvement after 2 days so she shifted to Allegra giving her 2x a day.  Patient had received any other vaccines in the 4 weeks prior to COVID-19 vaccine.   This case was linked to US-MODERNATX, INC.-MOD-2023-748711 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748711:different patient case
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, COVID-19 immunisation, Dizziness, Interchange of vaccine products, Vomiting
Clinical narrative: was having problems with her stomach; She states she has had mostly Pfizer; she had one Moderna; She states she has had mostly Pfizer; she had one Moderna; vomiting; dizziness; This spontaneous case was reported by a patient and describes the occurrence of ABDOMINAL DISCOMFORT (was having problems with her stomach), VOMITING (vomiting), DIZZINESS (dizziness), COVID-19 IMMUNISATION (She states she has had mostly Pfizer; she had one Moderna) and INTERCHANGE OF VACCINE PRODUCTS (She states she has had mostly Pfizer; she had one Moderna) in an 81-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer. Past adverse reactions to the above products included No adverse event with Pfizer.    On 08-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 09-Nov-2023, the patient experienced VOMITING (vomiting) and DIZZINESS (dizziness). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (was having problems with her stomach), COVID-19 IMMUNISATION (She states she has had mostly Pfizer; she had one Moderna) and INTERCHANGE OF VACCINE PRODUCTS (She states she has had mostly Pfizer; she had one Moderna). On 09-Nov-2023, VOMITING (vomiting) and DIZZINESS (dizziness) had resolved. At the time of the report, ABDOMINAL DISCOMFORT (was having problems with her stomach) had resolved and COVID-19 IMMUNISATION (She states she has had mostly Pfizer; she had one Moderna) and INTERCHANGE OF VACCINE PRODUCTS (She states she has had mostly Pfizer; she had one Moderna) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. Treatment information was not provided.   The patient confirmed contact information. She had very bad symptoms, felt very dizzy and was having problems with her stomach. She threw up. She states she is better now, but it was bad when she had it in the morning. The patient states she has been getting the COVID vaccines regularly. The last one was a year ago in November. The dates and vaccines are unknown. She states she has had mostly Pfizer; she had one Moderna. The patient was not sure if she received Spikevax yesterday, but she did get a COVID19 vaccine yesterday 8 Nov 2023.   Most recent FOLLOW-UP information incorporated above includes: On 09-Nov-2023: Significant live follow-up received. Reporter details, event details , LRN added.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Feeding disorder, Headache, Musculoskeletal stiffness
Clinical narrative: I haven't been able to eat anything because I am super Nauseous; Im in Just total pain; dizziness; I haven't been able to eat anything because I am super Nauseous; Fever of 102; Excruciating headaches; body aches; Extreme stiffness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Extreme stiffness), FEEDING DISORDER (I haven't been able to eat anything because I am super Nauseous), PAIN (Im in Just total pain), DIZZINESS (dizziness) and NAUSEA (I haven't been able to eat anything because I am super Nauseous) in a  patient of an unknown age and gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 08-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 08-Nov-2023, the patient experienced MUSCULOSKELETAL STIFFNESS (Extreme stiffness), PAIN (Im in Just total pain), DIZZINESS (dizziness), NAUSEA (I haven't been able to eat anything because I am super Nauseous), PYREXIA (Fever of 102), HEADACHE (Excruciating headaches) and MYALGIA (body aches). On an unknown date, the patient experienced FEEDING DISORDER (I haven't been able to eat anything because I am super Nauseous). At the time of the report, MUSCULOSKELETAL STIFFNESS (Extreme stiffness), FEEDING DISORDER (I haven't been able to eat anything because I am super Nauseous), DIZZINESS (dizziness), NAUSEA (I haven't been able to eat anything because I am super Nauseous), PYREXIA (Fever of 102), HEADACHE (Excruciating headaches) and MYALGIA (body aches) had not resolved and PAIN (Im in Just total pain) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown Route) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown Route), the reporter did not provide any causality assessments.   Concomitant medication was not reported. Patient got Moderna vaccine on 08-Nov-2023 and had severe side effects to it. Excruciating headaches, body aches, Dizziness. Extreme Stiffness. Patient haven't Left since yesterday. Patient haven't been able to eat anything because patient was super Nauseous. Patient was in just total pain and had a fever of 102. Treatment medication was not reported.   Reporter did not allow further contact