chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: U
Vaccine: MNQ
Symptoms: Incorrect route of product administration
Clinical narrative: Menveo was administered by subcutaneous route; This non-serious case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a 19-year-old patient who received Men ACWY-CRM NVS (Menveo) (batch number AMA7928) for prophylaxis.   On an unknown date, the patient received Menveo (subcutaneous). On an unknown date, an unknown time after receiving Menveo, the patient experienced intramuscular formulation administered by other route (Verbatim: Menveo was administered by subcutaneous route).  The outcome of the intramuscular formulation administered by other route was unknown.   Additional Information: GSK Receipt Date: 06-OCT-2023 The nurse reported that Menveo was administered by subcutaneous route which led to intramuscular formulation administered by other route. The reporter consented to follow up via email. The vaccine administration facility is the same as primary reporter.
Age: 93.0
Sex: M
Vaccine: RSV
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: patient received his first dose on 3-OCT-2023 and the second dose today 6-OCT-2023; supposed to receive a COVID-19 vaccine today but was accidently given the AREXVY; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 93-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number nm5g5, expiry date 05-MAR-2025) for prophylaxis.   Concomitant products included RSV VACCINE PROT. SUBUNIT PREF3 (AREXVY).   On 06-OCT-2023, the patient received the 2nd dose of Arexvy. On 06-OCT-2023, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: patient received his first dose on 3-OCT-2023 and the second dose today 6-OCT-2023) and wrong vaccine administered (Verbatim: supposed to receive a COVID-19 vaccine today but was accidently given the AREXVY). The outcome of the extra dose administered and wrong vaccine administered were unknown.   Additional Information: GSK receipt date: 06-OCT-2023 The reporter stated that a patient accidently received 2 doses of Arexvy vaccine, which led to extra dose administered.  The patient received his first dose on 03-OCT-2023 and the second dose today (on the day of reporting). He was supposed to receive a COVID-19 vaccine today but was accidently given the Arexvy, which led to wrong vaccine administered. Both doses had the same lot number and expiration date. The consent to follow up granted.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Inappropriate schedule of vaccine; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received 2 years prior to the reporting).   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 schedule of vaccine).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 06-OCT-2023 It was reported that patient received the 1st dose of a shingles vaccine (she could not confirm if the vaccine was Shingrix-manufacturer unknown), might be 2 years prior to the reporting, and till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination. The patient went to her pharmacy, and they could not find her vaccination record. The patient has no further information to provide about this event, no lot/expiry, no route of administration, and cannot remember the location of administration. I have reported the adverse event as Shingrix based on the patient being told to call us by her pharmacy, that she knew she should have gotten a 2nd dose, and per content if GSK manufactures a vaccine for the reported disease state, enter product name as GSK brand name and list as manufacturer unknown in comments. Consent to follow up with HCP was obtained. The vaccine administration facility is same as primary reporter for 1st dose.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: patient was administered only the adjuvant component of Shingrix.; patient was administered only the adjuvant component of Shingrix.; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: patient was administered only the adjuvant component of Shingrix.) and inappropriate dose of vaccine administered (Verbatim: patient was administered only the adjuvant component of Shingrix.).  The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 06-OCT-2023 Pharmacy student reports a patient was administered only the adjuvant component of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter consented to follow up. This happened at a nursing home not at the pharmacy and  HCP had no information about the patient or when it happened  follow-up was ok at the address above and it could be send it to ATTN: pharmacist in charge.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Heart rate increased
Clinical narrative: Pulse changes; This non-serious case was reported by a consumer via call center representative and described the occurrence of pulse increased in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cardiac pacemaker insertion.   On 14-SEP-2023, the patient received the 1st dose of Shingrix (left arm). On 16-SEP-2023, 2 days after receiving Shingrix, the patient experienced pulse increased (Verbatim: Pulse changes).  The outcome of the pulse increased was not resolved.   It was unknown if the reporter considered the pulse increased to be related to Shingrix.     It was unknown if the company considered the pulse increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 06-OCT-2023 Reporter was a patient that reports that she received the 1st dose of Shingrix in her left arm and starting on, her pulse, which is normally in the 60's to low 70's, is all over the place, with readings of 100, 99, and 98 on the 16th of September 2023. Patient reports she was still having this problem as of last night, 5th October 2023, when her pulse went from 60's to 100, while she was sitting down. Patient reports she has a pace maker which she got November 2022 (pre existing Shingrix vaccine). Patient also reports her physician has put her on a low salt diet; but, if she eats something with salt, it does not seem to affect her pulse. Consent to follow up with HCP was obtained.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB
Symptoms: Incorrect dose administered
Clinical narrative: Pediarix and Pentacel administered on same day (overdose of DTap and IPV); This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 4-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number 39KS9, expiry date 07-SEP-2025) for prophylaxis.   Co-suspect products included PENTACEL for prophylaxis.   Previously administered products included Pediarix (received 1st dose on an unknown date ).   On 06-OCT-2023, the patient received the 2nd dose of Pediarix and PENTACEL. On 06-OCT-2023, an unknown time after receiving Pediarix, the patient experienced overdose (Verbatim: Pediarix and Pentacel administered on same day (overdose of DTap and IPV)).  The outcome of the overdose 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 6 Oct 2023 Director stated that a CMA administered Pediarix and Pentacel to a patient on the day of reporting. The patient initially started the Pediarix series and this is the 2nd dose administered today along with the Pentacel, which led to overdose of DTaP and IPV. The reporter consented to follow up.  The vaccine administration facility was the same as primary reporter.
Age: 74.0
Sex: M
Vaccine: RSV
Symptoms: Dizziness, Euphoric mood, Feeling abnormal, Feeling drunk, Vertigo
Clinical narrative: felt drunk or high; he felt drunk; felt dizzy; thought he might fall; head spinning; This non-serious case was reported by a consumer via call center representative and described the occurrence of feeling high in a 74-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) (batch number y2j2b, expiry date 29-JAN-2025) for prophylaxis.   On 19-SEP-2023, the patient received the 1st dose of Arexvy (left arm). On 19-SEP-2023, 30 min after receiving Arexvy, the patient experienced feeling high (Verbatim: felt drunk or high), feeling drunk (Verbatim: he felt drunk), dizziness (Verbatim: felt dizzy), feeling abnormal (Verbatim: thought he might fall) and head spinning (Verbatim: head spinning). The outcome of the feeling high, feeling drunk, dizziness, feeling abnormal and head spinning were resolved (duration 2 hrs).   It was unknown if the reporter considered the feeling high, feeling drunk, dizziness, feeling abnormal and head spinning to be related to Arexvy.     It was unknown if the company considered the feeling high, feeling drunk, dizziness, feeling abnormal and head spinning to be related to Arexvy.  Additional Information: GSK Receipt Date: 06-OCT-2023 The patient received a dose of Arexvy and approximately 30 minutes after the injection he felt drunk or high, dizzy and thought he might fall, and his head was spinning. This lasted for about 2 hours and then all symptoms resolved. The reporter consented to follow up.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: inadvertently administered a third dose on 05Oct2023.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 68-year-old female patient who received Herpes zoster (Shingrix) (batch number EB4E4) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 29th March 2023, from batch 29EY3) and Shingrix (2nd dose received on 31st May 2023, from batch 34EC5).   On 05-OCT-2023, the patient received the 3rd dose of Shingrix. On 05-OCT-2023, an unknown time after receiving Shingrix, the patient experienced extra dose administered (Verbatim: inadvertently administered a third dose on 05Oct2023.).  The outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 06-OCT-2023 Pharmacist reports a patient inadvertently administered a third dose of Shingrix doses, which led to extra dose administered. The vaccine administration facility is the same as primary reporter. The reporter gave permission for follow-up.
Age: 74.0
Sex: F
Vaccine: RVX
Symptoms: Dizziness, Headache, Immediate post-injection reaction, Injection site pain, Loss of consciousness
Clinical narrative: soreness at the injection site; Headache; Felt like going to faint; Dry heaves; Passed out; Nauseous; This serious case was reported by a consumer via call center representative and described the occurrence of passed out in a 74-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   The patient's past medical history included fainting (fainted on airplanes and at dentist) and low blood pressure. Previously administered products included Flu vaccine with an associated reaction of vertigo (15 years ago, experienced Vertigo). Concomitant products included COVID-19 VACCINE (COVID VACCINE).   On 02-OCT-2023, the patient received RSV vaccine (left arm). On 02-OCT-2023, immediately after receiving RSV vaccine, the patient experienced injection site pain (Verbatim: soreness at the injection site) and headache (Verbatim: Headache). In OCT-2023, the patient experienced passed out (Verbatim: Passed out) (serious criteria GSK medically significant), nausea (Verbatim: Nauseous), felt faint (Verbatim: Felt like going to faint) and dry heaves (Verbatim: Dry heaves).  The outcome of the passed out, injection site pain, headache, felt faint and dry heaves were resolved and the outcome of the nausea was resolved (duration 2 days).   It was unknown if the reporter considered the passed out, injection site pain, headache, nausea, felt faint and dry heaves to be related to RSV vaccine.     It was unknown if the company considered the passed out, injection site pain, headache, nausea, felt faint and dry heaves to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 09-OCT-2023 The reporter was a patient. The reporter reported that she received RSV GSK vaccine vaccine in the early afternoon of vaccination day. Shortly after vaccination the patient felt soreness at the injection site, and a headache. Around midnight of vaccination day, patient felt nauseous, and got up to use the bathroom, the patient felt like she was going to faint, and then laid herself down on the bathroom floor, the patient passed out, and  when she came to, went back to bed and experienced dry heaves. The patient experienced nausea for 2 days. The patient experienced vertigo from a FLU vaccine (undisclosed manufacturer) 15 years ago. The reporter received a COVID vaccine (Pfizer) in the right arm 2 weeks prior to receiving the AREXVY vaccine. The reporter did not state that she received AREXY by name, but stated it was the GSK RSV vaccine. The patient had fainted on airplanes and while at the dentist the patient describes the fainting as fainting from low blood pressure. The patient did not take her blood pressure during reporting time. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: RVX
Symptoms: Nausea, Retching
Clinical narrative: soreness at the injection site; Headache; Felt like going to faint; Dry heaves; Passed out; Nauseous; This serious case was reported by a consumer via call center representative and described the occurrence of passed out in a 74-year-old female patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   The patient's past medical history included fainting (fainted on airplanes and at dentist) and low blood pressure. Previously administered products included Flu vaccine with an associated reaction of vertigo (15 years ago, experienced Vertigo). Concomitant products included COVID-19 VACCINE (COVID VACCINE).   On 02-OCT-2023, the patient received RSV vaccine (left arm). On 02-OCT-2023, immediately after receiving RSV vaccine, the patient experienced injection site pain (Verbatim: soreness at the injection site) and headache (Verbatim: Headache). In OCT-2023, the patient experienced passed out (Verbatim: Passed out) (serious criteria GSK medically significant), nausea (Verbatim: Nauseous), felt faint (Verbatim: Felt like going to faint) and dry heaves (Verbatim: Dry heaves).  The outcome of the passed out, injection site pain, headache, felt faint and dry heaves were resolved and the outcome of the nausea was resolved (duration 2 days).   It was unknown if the reporter considered the passed out, injection site pain, headache, nausea, felt faint and dry heaves to be related to RSV vaccine.     It was unknown if the company considered the passed out, injection site pain, headache, nausea, felt faint and dry heaves to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 09-OCT-2023 The reporter was a patient. The reporter reported that she received RSV GSK vaccine vaccine in the early afternoon of vaccination day. Shortly after vaccination the patient felt soreness at the injection site, and a headache. Around midnight of vaccination day, patient felt nauseous, and got up to use the bathroom, the patient felt like she was going to faint, and then laid herself down on the bathroom floor, the patient passed out, and  when she came to, went back to bed and experienced dry heaves. The patient experienced nausea for 2 days. The patient experienced vertigo from a FLU vaccine (undisclosed manufacturer) 15 years ago. The reporter received a COVID vaccine (Pfizer) in the right arm 2 weeks prior to receiving the AREXVY vaccine. The reporter did not state that she received AREXY by name, but stated it was the GSK RSV vaccine. The patient had fainted on airplanes and while at the dentist the patient describes the fainting as fainting from low blood pressure. The patient did not take her blood pressure during reporting time. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hasn't received a second dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose two years ago).   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: hasn't received a second dose yet).  The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 9-Oct-2023 Pharmacist had no records of the first dose of Shingrix, so no exact vaccination date or lot number was reported. The reporter did not consent to follow-up. Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Alopecia, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: redness at injection site; pain at injection site; swelling at injection site; injection site was very hot; hair is falling out in clumps; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14-SEP-2023, the patient received the 1st dose of Shingrix (intramuscular, left arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site erythema (Verbatim: redness at injection site), injection site pain (Verbatim: pain at injection site), injection site swelling (Verbatim: swelling at injection site), injection site warmth (Verbatim: injection site was very hot) and hair loss (Verbatim: hair is falling out in clumps). The patient was treated with non-drug therapy (Ice Pack (No Medication)). The outcome of the injection site erythema, injection site pain, injection site swelling and injection site warmth were resolved and the outcome of the hair loss was not resolved.   It was unknown if the reporter considered the injection site erythema, injection site pain, injection site swelling, injection site warmth and hair loss to be related to Shingrix.     It was unknown if the company considered the injection site erythema, injection site pain, injection site swelling, injection site warmth and hair loss to be related to Shingrix.   Additional Information: GSK receipt date: 06-SEP-2023 The patient experienced pain, redness, swelling at injection site hours after receiving that lasted for about a week.  The patient also said injection site was very hot, where she had to use ice packs, that lasted about a week as well.  She reported her hair was falling out in clumps, started about a week ago and it had not resolved.  Phone number provided. The reporter consented to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site pain, Myalgia
Clinical narrative: soreness at the injection site; Arthralgia; Myalgia; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-OCT-2023, the patient received the 2nd dose of Shingrix (left arm). In OCT-2023, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: soreness at the injection site), arthralgia (Verbatim: Arthralgia) and myalgia (Verbatim: Myalgia).  In OCT-2023, the outcome of the injection site pain was resolved. The outcome of the arthralgia and myalgia were not resolved.   It was unknown if the reporter considered the injection site pain, arthralgia and myalgia to be related to Shingrix.     It was unknown if the company considered the injection site pain, arthralgia and myalgia to be related to Shingrix.   Additional Information: GSK receipt date: 9-Oct-2023 GlaxoSmithKline employee who received second dose of Shingrix vaccine and according to the reporting, she had soreness at the injection site that went away then developed myalgia and arthralgia that persisted on the day of reporting. Did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 2459T, expiry date 08-OCT-2023) for prophylaxis.   On 09-OCT-2023, the patient received Shingrix. On 09-OCT-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: Expired dose given).  The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 9-Oct-2023 A registered nurse called in to request information about how to proceed after a patient received a dose of Shingrix.  The reporter provided partial information about the event, patient and vaccine. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow-up. The patient received an expired dose of Shingrix, which led to expired vaccine used.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chemotherapy, Colon cancer
Clinical narrative: Colon Cancer; This serious case was reported by a pharmacist via call center representative and described the occurrence of colon cancer in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 08-OCT-2022, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced colon cancer (Verbatim: Colon Cancer) (serious criteria GSK medically significant).  The outcome of the colon cancer was unknown.   It was unknown if the reporter considered the colon cancer to be related to Shingrix.     It was unknown if the company considered the colon cancer to be related to Shingrix.   Additional Information: GSK Receipt Date: 11-OCT-2023 The pharmacist requested data on the administration of 2nd dose of Shingrix following completion of chemotherapy for colon cancer. The healthcare professional stated that patient had 1st Shingrix vaccine on 08th October 2022 and started chemotherapy in January 2023 and completed chemotherapy July 2023. The reporter consented to follow up.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Allergy to vaccine
Clinical narrative: Allergic to Moderna and everything in it; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (Allergic to Moderna and everything in it) in a 74-year-old patient of an unknown gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Autoimmune disorder.    In November 2022, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (Allergic to Moderna and everything in it). At the time of the report, ALLERGY TO VACCINE (Allergic to Moderna and everything in it) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       No concomitant medications were reported.  Patient had the bivalent 1 year ago last November. Stated had a rare auto immune disease, stated they need to adjust medication before takes the shot. Patient stated cannot take the Moderna at all and was allergic to everything in it, and Pfizer has been wonderful as it was the only safe brand patient can take.  No treatment medications were provided.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (Flu) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 064H21A and 027A2119) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA (Flu). At the time of the report, INFLUENZA (Flu) had resolved.            Concomitant medications were not reported. Patient had the rough time with Moderna vaccine. In May2022, patient received Pfizer vaccine batch lot no GJ3274 and on Sep2022, patient received Pfizer vaccine batch lot no FN2908. The last two Pfizer's doses patient had been completely fine, like hardly anything. Patient received Comirnaty vaccine in Nov2022 (dose: 0.3 milliliters, batch lot no HG4628, left arm). Patient had been so sick and such evicted to vaccines, patient still little worried. Patient had 102.5 fever, felt nauseous, threw up a few times, horrible body ache, patient sinus was literally killing, excruciating headache, no appetite, felt exhausted and then woke up with hives. In Jun2023, patient received Flucelvax Quad vaccine (batch lot no 9424O9). On 30Sep2023, patient had some improvement in hive, but again patient had some hive which was new. Patient still had a headache and fever which has been improved it now like about 100, it was 102.5 and patient not throwing up now. Patient had no energy, no appetite, sinuses were killing patient, but they do better when patient was up right. So, it was literally ever thing under the sun like patient experienced, like everything. Patient took a COVID test make sure that not had Covid and not have Covid. And the symptoms started patient took that around 11 and then at 3 o'clock patient started getting a headache, 6 o'clock patient started getting a body ache and then 8 o'clock patient had the terrible fever. Patient took Tylenol 325 milligrams and then took one medication and then patient had taken two other one of those. The patient again took Tylenol 325 milligrams.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This spontaneous case was reported by a patient and describes the occurrence of HERPES ZOSTER (shingles) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On 24-Dec-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HERPES ZOSTER (shingles). At the time of the report, HERPES ZOSTER (shingles) outcome was unknown.            No concomitant medication information was reported.  Patient stated that after receiving the Moderna COVID-19 booster vaccine, she developed shingles.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site; She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site) and INJECTION SITE SWELLING (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson and Johnson Vaccine (Dose 1) on 09-Mar-2021 and Johnson and Johnson Vaccine (Dose 2) on 30-Oct-2021. Past adverse reactions to the above products included Bruise with Johnson and Johnson Vaccine; and No adverse event with Johnson and Johnson Vaccine.    On 09-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site) and INJECTION SITE SWELLING (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site). At the time of the report, INJECTION SITE PAIN (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site) and INJECTION SITE SWELLING (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745104, US-MODERNATX, INC.-MOD-2023-745188 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745104:Master case for SPIKEVAX 2023-2024 PFS US-MODERNATX, INC.-MOD-2023-745188:Bivalent Dose
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site.; She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site.; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE PAIN (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site.) and INJECTION SITE SWELLING (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site.) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Johnson and Johnson Vaccine (Dose 1) since 09-Mar-2021 and Johnson and Johnson Vaccine (Dose 2) on 30-Oct-2021. Past adverse reactions to the above products included Bruise with Johnson and Johnson Vaccine; and No adverse event with Johnson and Johnson Vaccine.    On 20-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site.) and INJECTION SITE SWELLING (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site.). At the time of the report, INJECTION SITE PAIN (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site.) and INJECTION SITE SWELLING (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site.) 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 concomitant medications were reported. The patient didn't receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-745104, US-MODERNATX, INC.-MOD-2023-745185 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745104:Master case for SPIKEVAX 2023-2024 PFS US-MODERNATX, INC.-MOD-2023-745185:Monovalent dose
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got sick; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Got sick) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    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 (Got sick). At the time of the report, ILLNESS (Got sick) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       It was reported that it was over a year since the patient got last booster vaccination. The patient was having some difficult time in figuring out where to get the new vaccine. The patient got sick upon taking Moderna vaccine one time however, the Pfizer vaccine did well. Hence the patient wanted to take Pfizer vaccine again. The patient queried if in the pharmacy, they were administering the old vaccine or offering the new 2023-24 formula dose. The patient was informed that the patient might have a possible drug interaction since the patient received both the Moderna and Pfizer vaccines.  Treatment information was not provided.
Age: 65.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Breakthrough COVID-19, SARS-CoV-2 test positive
Clinical narrative: got breakthrough COVID after receiving the vaccine/covid 19; This spontaneous case was reported by a patient and describes the occurrence of BREAKTHROUGH COVID-19 (got breakthrough COVID after receiving the vaccine/covid 19) in a 65-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3030368) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Patient had no allergy, concomitant diseases and risk factor. COVID-19 history reported as none.  Previously administered products included for COVID-19 prophylaxis: Moderna Covid-19 vaccine (Dose 1, Lot # 045A21A) on 24-Mar-2021, Moderna Covid-19 vaccine (Dose 2, Lot # 002C21A) on 21-Apr-2021, Moderna Covid-19 vaccine (Dose 3, Lot # 058H21A) on 06-Jan-2022, MODERNA COVID-19 VACCINE (Dose 4, Lot # 004M21A) on 07-May-2022, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5) (Dose 5 and Lot # 059F22A) on 18-Nov-2022. Past adverse reactions to the above products included No adverse reaction with MODERNA COVID-19 VACCINE, MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5), Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine.   In September 2023, the patient received dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 16-Sep-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 01-Oct-2023, the patient experienced BREAKTHROUGH COVID-19 (got breakthrough COVID after receiving the vaccine/covid 19). At the time of the report, BREAKTHROUGH COVID-19 (got breakthrough COVID after receiving the vaccine/covid 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2023, SARS-CoV-2 test: Positive.     For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  Reported that patient received flu shot a week after Spikevax 2023-2024.   This case was linked to US-MODERNATX, INC.-MOD-2023-745332 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 12-Oct-2023: Live significant follow up received. Reference numbers added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745332:husband case
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Nausea
Clinical narrative: chills; nausea/she felt like vomiting all night; It was awful; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (It was awful), CHILLS (chills) and NAUSEA (nausea/she felt like vomiting all night) in an 83-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3031283) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 in January 2023. Previously administered products included for COVID-19 vaccination: Moderna Covid-19 vaccine (Dose Number: 1, Batch/Lot No: 026L20A) on 01-Jan-2021, Moderna Covid-19 vaccine (Dose Number: 2, Batch/Lot No: 029L20A) on 08-Feb-2021, Moderna Covid-19 vaccine (Dose Number: 3 and Batch/Lot No: 037F21A) on 18-Nov-2021. Past adverse reactions to the above products included No adverse event with Moderna Covid-19 vaccine, Moderna Covid-19 vaccine and Moderna Covid-19 vaccine. Concurrent medical conditions included Penicillin allergy and Drug allergy (Percocet and a medication for pain (did not remember name)).    On 02-Oct-2023, the patient received fourth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. On 02-Oct-2023, the patient experienced FEELING ABNORMAL (It was awful) and NAUSEA (nausea/she felt like vomiting all night). On 02-Oct-2023 at 7:00 PM, the patient experienced CHILLS (chills). At the time of the report, FEELING ABNORMAL (It was awful), CHILLS (chills) and NAUSEA (nausea/she felt like vomiting all night) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided.  Patient received Spikevax on 02-Oct-2023 at the morning. By 10:00 PM she was so chilled she could not even hold anything. She went to bed and could sleep for 2 hours. She got up with such nausea and felt like she was going to vomit until 5 AM. Patient fell asleep and woke up after noon. It was not mild, she felt like vomiting all night. She was really sick. Patient reported that her arm was perfect, she did not even have a sore arm. She never experienced something like this for past Moderna vaccine doses.  Treatment information was not reported.
Age: 54.0
Sex: F
Vaccine: UNK
Symptoms: Asthenia, Feeling of body temperature change, Gait disturbance, Myalgia, Throat irritation
Clinical narrative: she can barely walk; scratchy throat; feel weak; feeling warm and cold; sore muscles; This spontaneous case was reported by a patient and describes the occurrence of GAIT DISTURBANCE (she can barely walk), THROAT IRRITATION (scratchy throat), ASTHENIA (feel weak), FEELING OF BODY TEMPERATURE CHANGE (feeling warm and cold) and MYALGIA (sore muscles) in a 54-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Influenza vaccine. on 07-Sep-2023. Past adverse reactions to the above products included No adverse event with Influenza vaccine.    On 08-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 09-Oct-2023, the patient experienced GAIT DISTURBANCE (she can barely walk), THROAT IRRITATION (scratchy throat), ASTHENIA (feel weak), FEELING OF BODY TEMPERATURE CHANGE (feeling warm and cold) and MYALGIA (sore muscles). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (she can barely walk), THROAT IRRITATION (scratchy throat), ASTHENIA (feel weak) and MYALGIA (sore muscles) had not resolved and FEELING OF BODY TEMPERATURE CHANGE (feeling warm and cold) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.  It was reported that patient has received doses of the Moderna COVID-19 vaccines in the order: MAR of unknown unknown year 2 Months later got the second one on Mother's Day same year. Last year went to local pharmacy and got a booster shot (2022). Last year (2022) got another vaccine that was the same thing as the previous dose. The symptoms were started this morning when patient woke's up.
Age: 76.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Headache, Pyrexia, Vomiting
Clinical narrative: dizziness; vomiting; blinding headache; slight fever of 99.3 F; This spontaneous case was reported by a patient and describes the occurrence of DIZZINESS (dizziness), VOMITING (vomiting), HEADACHE (blinding headache) and PYREXIA (slight fever of 99.3 F) in a 76-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna (Dose number 1, lot number is 030L20A) on 15-Jan-2021, Moderna (Dose number 2, lot number is 024M20A) on 12-Feb-2021, Moderna (Dose number 3, lot number is 019F21A/039F21A) on 03-Nov-2021, Moderna (Dose number 4, lot number is 004M21A) on 05-May-2022, Moderna (Dose number 5, lot number is 057F22A) on 02-Oct-2022, Moderna (Dose number 6 and lot number is AF7184B) on 06-Sep-2023; for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included No adverse event with Flu shot, Moderna, Moderna, Moderna, Moderna, Moderna and Moderna. Concurrent medical conditions included Vertigo.    On 23-Sep-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced HEADACHE (blinding headache) and PYREXIA (slight fever of 99.3 F). On 29-Sep-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced DIZZINESS (dizziness) and VOMITING (vomiting). At the time of the report, DIZZINESS (dizziness), VOMITING (vomiting), HEADACHE (blinding headache) and PYREXIA (slight fever of 99.3 F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2023, Body temperature: 99.3 F.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site paraesthesia, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Every once and a while she gets tingles, itches; she gets tingles; She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site; swelling at the injection site/with a small, red, warm swelling; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Every once and a while she gets tingles, itches), INJECTION SITE PARAESTHESIA (she gets tingles), VACCINATION SITE PAIN (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site/with a small, red, warm swelling) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 709F23A) for COVID-19 prophylaxis.     The patient's past medical history included Clot blood.    On 07-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) 1 dosage form. In 2023, the patient experienced INJECTION SITE PRURITUS (Every once and a while she gets tingles, itches), INJECTION SITE PARAESTHESIA (she gets tingles), VACCINATION SITE PAIN (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site/with a small, red, warm swelling). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and MEFENAMIC ACID (ADVIL [MEFENAMIC ACID]) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PRURITUS (Every once and a while she gets tingles, itches), INJECTION SITE PARAESTHESIA (she gets tingles), VACCINATION SITE PAIN (She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site) and VACCINATION SITE SWELLING (swelling at the injection site/with a small, red, warm swelling) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  She has received 5 doses COVID-19 vaccines on 9-MAR-2021, received Johnson and Johnson Vaccine. Had a big bruise after that one. On 30-OCT-2021 Moderna, 9-APR-2022 Moderna, 20-SEP-2022 Moderna. On 7-OCT-2023 Spikevax PFS, lot number 709F23A She usually gets pain after receiving a vaccine with tenderness and swelling at the injection site.  Following her most recent dose she had the same thing with a small, red, warm swelling, in her left upper arm. Sunday, Monday, and today the size of where the shot was has gotten bigger. It was now 3 in x 3 in. Every once and a while she gets tingles, itches, and more pain.   This case was linked to US-MODERNATX, INC.-MOD-2023-745185, US-MODERNATX, INC.-MOD-2023-745188 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-745188:Bivalent dose US-MODERNATX, INC.-MOD-2023-745185:Monovalent dose
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in an 83-year-old male patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch nos. ASKU, ASKU and ASKU) for COVID-19 prophylaxis.     The patient's past medical history included Cancer (NOS) (survivor). Concurrent medical conditions included Type 2 diabetes mellitus.   On an unknown date, the patient received first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) had resolved.        For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were provided.   Reporter did not allow further contact