chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Scar, Vaccination failure
Clinical narrative: suspected vaccination failure; got a horrible case of shingles on my right leg; scar on leg; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine (receive Shingles vaccine on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. In SEP-2023, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got a horrible case of shingles on my right leg) and scar (Verbatim: scar on leg). The outcome of the vaccination failure and shingles were not reported and the outcome of the scar was not resolved.   It was unknown if the reporter considered the vaccination failure, shingles and scar to be related to Shingrix and Shingrix.     The company considered the vaccination failure to be related to Shingrix and Shingrix. It was unknown if the company considered the shingles and scar to be related to Shingrix and Shingrix.   Additional Information: GSK Receipt Date: 22-SEP-2024 This case was reported by the patient via interactive digital media. The patient got the shingles shot two times. The first one was only one shot then later he/she got the Shingrix shot with the two shots. In the last September patient got a horrible case of shingles on him right leg and he/she still had scars all down him leg and it doesn't like they are going away. This case was considered as suspected vaccination failure as details regarding, time to onset, laboratory details and shingles were known at a time of reporting.; Sender's Comments: Vaccination failure is a listed event which is considered related to GSK vaccine Shingrix.
Sex: U
Vaccine: RVX
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: injection site swelled about the size of a walnut; Injection site red; sore at injection site; injection site still swollen and now itchy; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site swelling in a patient who received RSVPreF3 adjuvanted (RSV vaccine) for prophylaxis.   On an unknown date, the patient received RSV vaccine. On an unknown date, an unknown time after receiving RSV vaccine, the patient experienced injection site swelling (Verbatim: injection site swelled about the size of a walnut), injection site erythema (Verbatim: Injection site red), injection site pain (Verbatim: sore at injection site) and injection site itching (Verbatim: injection site still swollen and now itchy). The outcome of the injection site swelling and injection site itching were not resolved and the outcome of the injection site erythema and injection site pain were not reported.   It was unknown if the reporter considered the injection site swelling, injection site erythema, injection site pain and injection site itching to be related to RSV vaccine.     It was unknown if the company considered the injection site swelling, injection site erythema, injection site pain and injection site itching to be related to RSV vaccine.   Additional Information: GSK Receipt Date: 16-SEP-2024 The patient self-reported this case. The patient got the RSV vaccine and his/her injection site swelled up about the size of walnut, red, sore and it was still swollen and now it was itchy. He/she hope it was better tomorrow and it keeps him/her from getting RSV.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Malaise
Clinical narrative: red mark; Sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included immune system disorder.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: Sick) and erythema (Verbatim: red mark). The outcome of the sickness was resolved (duration 4 months) and the outcome of the erythema was not resolved.   It was unknown if the reporter considered the sickness and erythema to be related to Shingrix.     It was unknown if the company considered the sickness and erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-SEP-2024 The case was received from the patient interactive digital media.  The patient did not know the patient had immunity problem and was sick for four months because of getting one dose of the vaccine. The patient also got a red mark. The patient could not had a vaccine for protection against shingles. The patient could not had any of those shots for protection, everybody talk to their physician first.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: feel sick; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Family history included shingles (patient watched both his/her in-laws suffer through shingles).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced sickness (Verbatim: feel sick). The outcome of the sickness was resolved (duration 2 days).   It was unknown if the reporter considered the sickness to be related to Shingrix.     It was unknown if the company considered the sickness to be related to Shingrix.   Additional Information: GSK Receipt Date: 17-SEP-2024 This case was reported by a patient via interactive digital media. The patient was never so happy to get his/her shots of Shingrix vaccine though they made him/her felt sick. It was only lasted 2 days and minimal compared to shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Allergy to vaccine
Clinical narrative: allergic to shingles vaccine; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of allergy to vaccine in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced allergy to vaccine (Verbatim: allergic to shingles vaccine). The outcome of the allergy to vaccine was not reported.   It was unknown if the reporter considered the allergy to vaccine to be related to Shingles vaccine.     It was unknown if the company considered the allergy to vaccine to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-SEP-2024 This case was reported by a patient via interactive digital media. The patient discovered he/she was highly allergic to the shingles vaccine. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: she experienced soreness of the injected arm after the first dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: she experienced soreness of the injected arm after the first dose). The outcome of the injection site pain was not reported.   It was unknown if the reporter considered the injection site pain to be related to Shingrix.     It was unknown if the company considered the injection site pain to be related to Shingrix.   Linked case(s) involving the same patient:  US2024116140   Additional Information: GSK Receipt Date: 18-SEP-2024  The patient self-reported this case for herself. The patient reported that she experienced soreness of the injected arm after the first dose of Shingrix. For tolerance of second dose refer case US2024116140.; Sender's Comments:  US-GSK-US2024116140:Same patient 1st dose
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Diarrhoea, Eye disorder, Injection site pain
Clinical narrative: low energy; fever; chills; diarrhea; pain at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had in March 2024) and exanthema facial (had rash on right side of face). Previously administered products included Varicella zoster vaccine (received in 2009).   On 12-SEP-2024, the patient received the 1st dose of Shingrix (right arm). On 12-SEP-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site). On 13-SEP-2024, the patient experienced energy decreased (Verbatim: low energy), fever (Verbatim: fever), chills (Verbatim: chills) and diarrhea (Verbatim: diarrhea). The outcome of the injection site pain, energy decreased, fever, chills and diarrhea were resolved.   It was unknown if the reporter considered the injection site pain, energy decreased, fever, chills and diarrhea to be related to Shingrix.     It was unknown if the company considered the injection site pain, energy decreased, fever, chills and diarrhea to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-SEP-2024 This case was self-reported by patient. The reporter states she had a dose of a shingles vaccine in 2009.  She reports having shingles in March of 2024, rash on right side of face and it affected her right eyes as well. The patient received Shingrix dose 1st on 12th September 2024 and had pain at injection site that was right arm. The next day she had low energy, fever, chills, dirrhoea 2 episodes and states that she was afraid to get dose 2nd.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Rash
Clinical narrative: low energy; fever; chills; diarrhea; pain at injection site; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had in March 2024) and exanthema facial (had rash on right side of face). Previously administered products included Varicella zoster vaccine (received in 2009).   On 12-SEP-2024, the patient received the 1st dose of Shingrix (right arm). On 12-SEP-2024, less than a day after receiving Shingrix, the patient experienced injection site pain (Verbatim: pain at injection site). On 13-SEP-2024, the patient experienced energy decreased (Verbatim: low energy), fever (Verbatim: fever), chills (Verbatim: chills) and diarrhea (Verbatim: diarrhea). The outcome of the injection site pain, energy decreased, fever, chills and diarrhea were resolved.   It was unknown if the reporter considered the injection site pain, energy decreased, fever, chills and diarrhea to be related to Shingrix.     It was unknown if the company considered the injection site pain, energy decreased, fever, chills and diarrhea to be related to Shingrix.   Additional Information: GSK Receipt Date: 16-SEP-2024 This case was self-reported by patient. The reporter states she had a dose of a shingles vaccine in 2009.  She reports having shingles in March of 2024, rash on right side of face and it affected her right eyes as well. The patient received Shingrix dose 1st on 12th September 2024 and had pain at injection site that was right arm. The next day she had low energy, fever, chills, dirrhoea 2 episodes and states that she was afraid to get dose 2nd.
Age: 76.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Product administered to patient of inappropriate age, Pruritus
Clinical narrative: 76-years-old patient received Bexsero vaccine; redness all over her upper body; itching; This non-serious case was reported by a consumer via call center representative and described the occurrence of generalized erythema in a 76-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included splenectomy.   On 10-JUL-2024, the patient received the 2nd dose of Bexsero. On 10-JUL-2024, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: 76-years-old patient received Bexsero vaccine). In JUL-2024, the patient experienced generalized erythema (Verbatim: redness all over her upper body) and pruritus (Verbatim: itching). The outcome of the generalized erythema, pruritus and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the generalized erythema and pruritus to be related to Bexsero and Bexsero Pre-Filled Syringe Device.     It was unknown if the company considered the generalized erythema and pruritus to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   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: 16-SEP-2024 The patient self-reported this case. The reporter reported that she had received Bexsero vaccine and after 50 minutes of vaccination she developed redness all over her upper body and itching. The reporter provided information about her health and noted that she had a splenectomy and believed that to be the reason for the reaction to the vaccine. 76-years-old patient received Bexsero vaccine later than the given age, which led to an inappropriate age at vaccine administration.
Age: 67.0
Sex: M
Vaccine: RSV
Symptoms: Fatigue, Single component of a two-component product administered, Vertigo
Clinical narrative: one of them only received the adjuvant portion of the vaccine and they do not know which one it is; one of them only received the adjuvant portion of the vaccine; Fatigue; Vertigo; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 02-AUG-2024, the patient received Arexvy. On 02-AUG-2024, an unknown time after receiving Arexvy, the patient experienced inappropriate preparation of medication (Verbatim: one of them only received the adjuvant portion of the vaccine and they do not know which one it is) and inappropriate dose of vaccine administered (Verbatim: one of them only received the adjuvant portion of the vaccine). In AUG-2024, the patient experienced fatigue (Verbatim: Fatigue) and vertigo (Verbatim: Vertigo). In AUG-2024, the outcome of the fatigue and vertigo were resolved (duration 2 days). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   It was unknown if the reporter considered the fatigue and vertigo to be related to Arexvy.     It was unknown if the company considered the fatigue and vertigo to be related to Arexvy.   Additional Information: GSK Receipt Date: 16-SEP-2024 The reporter was the wife of the patient. The reporter and her husband (patient) went to the pharmacy to get the RSV vaccine.  The reporter did not have any identifying numbers for either of the suspect RSV vaccines.  The patient was told on the telephone by a pharmacist that the RSV vaccine was GSK brand.  The reporter stated that when she went home, she received a call from the pharmacist. The pharmacist told her that one of them only received the adjuvant portion of the vaccine and they did not know which one it was, which led to an inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter stated that, her husband (patient) had fatigue and vertigo 2 hours after receiving suspect vaccine that resolved in 2 days. The reporter reported that she reported this adverse event to Vaccine Adverse Event Reporting System (VAERS). This case had been linked with US2024114969, reported by the same reporter.; Sender's Comments:  US-GSK-US2024114969:Same reporter,Different patient
Age: 5.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Engerix-B adult dose was given to a 5 year old patient inadvertently; an Engerix-B adult dose was given to a 5 year old patient inadvertently; This non-serious case was reported by a other health professional via call center representative and described the occurrence of overdose in a 5-year-old female patient who received HBV (Engerix B adult) (batch number 9LA2G, expiry date 21-AUG-2026) for prophylaxis.   On 16-SEP-2024, the patient received Engerix B adult. On 16-SEP-2024, an unknown time after receiving Engerix B adult, the patient experienced overdose (Verbatim: Engerix-B adult dose was given to a 5 year old patient inadvertently) and adult product administered to child (Verbatim: an Engerix-B adult dose was given to a 5 year old patient inadvertently). The outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK Receipt Date: 17-SEP-2024 The other health professional report that an Engerix-B adult dose was given to a 5 year old patient inadvertently which led to overdose and adult product administered to child.  The Vaccine Administration Facility was the same as Primary Reporter.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR
Symptoms: Decreased appetite, Pain
Clinical narrative: low grade fever (99.9 degrees); overall body pain; loss of appetite; This non-serious case was reported by a consumer via call center representative and described the occurrence of low grade fever in a 4-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included MMR (MMR vaccine) (batch number 5h95b, expiry date 16-FEB-2026) for prophylaxis.   On 16-SEP-2024, the patient received Kinrix (left arm) and MMR vaccine (right arm). In SEP-2024, an unknown time after receiving Kinrix and MMR vaccine, the patient experienced low grade fever (Verbatim: low grade fever (99.9 degrees)), general body pain (Verbatim: overall body pain) and appetite lost (Verbatim: loss of appetite). The outcome of the low grade fever, general body pain and appetite lost were unknown.   It was unknown if the reporter considered the low grade fever, general body pain and appetite lost to be related to Kinrix, Kinrix Pre-Filled Syringe Device, MMR vaccine and Priorix Pre-Filled Syringe Device.     It was unknown if the company considered the low grade fever, general body pain and appetite lost to be related to Kinrix, Kinrix Pre-Filled Syringe Device, MMR vaccine and Priorix Pre-Filled Syringe Device.   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: 17-SEP-2024 Reporter was the patient's mother. The patient received a dose of Kinrix yesterday (day before reporting) at the same time as an MMR vaccine (unknown manufacturer).  The Kinrix was administered in the patient's left arm and the MMR vaccine in the back of the patient's right arm.  The patient was experiencing loss of appetite, overall body pain, and a low grade fever of 99.9 degrees. Did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: The diluent was administered without the vaccine Shingrix; The diluent was administered without the vaccine Shingrix; This non-serious case was reported by a pharmacist 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: The diluent was administered without the vaccine Shingrix) and inappropriate dose of vaccine administered (Verbatim: The diluent was administered without the vaccine Shingrix). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receive date: 17-SEP-2024 Pharmacist did not have much information. Pharmacist was called to got bands to kept the powder and diluent together to avoid the administration of only the diluent. The patient received only adjuvant of Shingrix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: Priorix was administered as intramuscular injection; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate route of vaccination in a 33-year-old female patient who received MMR (Priorix) (batch number 47e32, expiry date 01-NOV-2024) for prophylaxis.   On 17-SEP-2024, the patient received Priorix (intramuscular). On 17-SEP-2024, an unknown time after receiving Priorix, the patient experienced inappropriate route of vaccination (Verbatim: Priorix was administered as intramuscular injection). The outcome of the inappropriate route of vaccination 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: 17-SEP-2024 The Priorix was administered as intramuscular injection to a patient, which led to inappropriate route of vaccination.
Age: 74.0
Sex: F
Vaccine: COVID19, FLUX, RSV
Symptoms: Extra dose administered, Fatigue
Clinical narrative: very fatigued after 24 hours; Arexvy already received earlier; This non-serious case was reported by a consumer via call center representative and described the occurrence of fatigue in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis and COVID-19 VACCINE for prophylaxis.   Previously administered products included Arexvy (1st dose received on 21st September 2023).   On 08-SEP-2024, the patient received Arexvy (intramuscular), INFLUENZA VACCINE and COVID-19 VACCINE. On 08-SEP-2024, an unknown time after receiving Arexvy, the patient experienced extra dose administered (Verbatim: Arexvy already received earlier). On 09-SEP-2024, the patient experienced fatigue (Verbatim: very fatigued after 24 hours). On 10-SEP-2024, the outcome of the fatigue was resolved (duration 1 day). The outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the fatigue to be related to Arexvy.     It was unknown if the company considered the fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 17-SEP-2024 The reporter was the wife. Reporter stated she and her spouse were leaving to go out of the country and the pharmacy told them to go ahead and get the Covid Vaccine, Arexvy vaccine and the flu vaccine after the licensed pharmacy technician gave the 3 vaccines the reporter realized she had the Arexvy already on 21st September 2023 which led to extra dose administered. Reporter stated the only thing that changed was being very fatigued after 24 hours.  This Adverse event did subside after 48 hours. It was unknown if the company considered the fatigue to be related to Influenza vaccine and Covid 19 vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: The patient knows a lot of people, this neighbor, who is going to the same clinic to measure the IgG-4 levels as they are becoming sick; This spontaneous case was reported by a non-health professional and describes the occurrence of ILLNESS (The patient knows a lot of people, this neighbor, who is going to the same clinic to measure the IgG-4 levels as they are becoming sick) in a patient of an unknown age and gender 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 (The patient knows a lot of people, this neighbor, who is going to the same clinic to measure the IgG-4 levels as they are becoming sick). At the time of the report, ILLNESS (The patient knows a lot of people, this neighbor, who is going to the same clinic to measure the IgG-4 levels as they are becoming sick) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-774396 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774396:neighbor case
Sex: F
Vaccine: COVID19
Symptoms: Neoplasm malignant, Thrombosis
Clinical narrative: severe blood clots; cancer; This spontaneous case was reported by a patient family member or friend and describes the occurrence of THROMBOSIS (severe blood clots) and NEOPLASM MALIGNANT (cancer) in a female patient of an unknown age 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 THROMBOSIS (severe blood clots) (seriousness criterion medically significant) and NEOPLASM MALIGNANT (cancer) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (severe blood clots) and NEOPLASM MALIGNANT (cancer) had not resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. Caller stated that her family member that had severe blood clots. The family member she was talking about was going through cancer treatments and this was after the family member got her shots.  Company Comment: This is a Spontaneous case reported by a patient family member or friend, concerning a female patient of unknown age, with no medical history reported, who experienced the unexpected and serious (due to medically significant) events of Thrombosis (AESI) and Neoplasm malignant, which occurred on an unknown date after an unspecified dose of SPIKEVAX COVID-19 VACCINE NOS. Since no vaccination nor event dates were provided, temporal association and latency cannot be properly assessed.  No information disclosed about diagnostic tests performed, clinical course or treatments received. The benefit-risk relationship of SPIKEVAX COVID-19 VACCINE NOS is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-724709 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-724709:Same reporter (Family member case)
Age: 7.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: COVID-19
Clinical narrative: tired, chills, body aches (about an hour); This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (tired, chills, body aches (about an hour)) in a 7-decade-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU VACCINE VII) for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1), Pfizer vaccine (Dose 3 Booster) and Pfizer vaccine (Dose 2). Past adverse reactions to the above products included No adverse effect with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine.   On 20-Sep-2024, the patient received fourth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU VACCINE VII) (unknown route) 1 dosage form. On 21-Sep-2024, the patient experienced COVID-19 (tired, chills, body aches (about an hour)). At the time of the report, COVID-19 (tired, chills, body aches (about an hour)) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2024, COVID-19: Positive. On 24-Sep-2024, COVID-19: Negative.         Patient was very healthy. No concomitant medication was reported.  On 21-SEP-2024 around 8:00 PM local time, caller reported that she started to feel tired, chills, body aches (about an hour). That night, caller reported needing help getting out of bed the first time. Caller self-tested for Covid, and test was positive. Caller called the PCP that night, reported no fever, nausea nor vomiting. PCP offered medicines but, caller refused. On 22-SEP-2024, caller reported having no more chills but reported no energy and no appetite. On 24-SEP-2024, caller reported feeling better but tired and tested negative for Covid-19.   No treatment information was reported.   Reporter did not allow further contact
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Chills, Gastritis, Headache
Clinical narrative: I have gastritis which got worse after receiving the vaccine/stomach pain/nauseous/not able to eat; got extreme pain in left shoulder and low back where I have chronic injuries.; still very sick from this vaccine; extreme pain in my right shoulder where I got the injection; also got extreme pain in left shoulder and low back where I have chronic injuries; chills; head ache; This spontaneous case was reported by a patient and describes the occurrence of GASTRITIS (I have gastritis which got worse after receiving the vaccine/stomach pain/nauseous/not able to eat), BACK PAIN (got extreme pain in left shoulder and low back where I have chronic injuries.), MALAISE (still very sick from this vaccine), VACCINATION SITE PAIN (extreme pain in my right shoulder where I got the injection) and ARTHRALGIA (also got extreme pain in left shoulder and low back where I have chronic injuries) in an 80-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (reaction was worse than when patient caught omicron over a year ago).    On 23-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 23-Sep-2024, the patient experienced GASTRITIS (I have gastritis which got worse after receiving the vaccine/stomach pain/nauseous/not able to eat), BACK PAIN (got extreme pain in left shoulder and low back where I have chronic injuries.), MALAISE (still very sick from this vaccine), VACCINATION SITE PAIN (extreme pain in my right shoulder where I got the injection), ARTHRALGIA (also got extreme pain in left shoulder and low back where I have chronic injuries), CHILLS (chills) and HEADACHE (head ache). At the time of the report, GASTRITIS (I have gastritis which got worse after receiving the vaccine/stomach pain/nauseous/not able to eat), BACK PAIN (got extreme pain in left shoulder and low back where I have chronic injuries.), MALAISE (still very sick from this vaccine), VACCINATION SITE PAIN (extreme pain in my right shoulder where I got the injection), ARTHRALGIA (also got extreme pain in left shoulder and low back where I have chronic injuries), CHILLS (chills) and HEADACHE (head ache) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter causality was not reported. Patient thinks that he need to take a reduced dose when he get a covid vaccine as he had too strong of a reaction to the dose.  It was unknown if the patient experienced any additional symptoms/events.  Treatment medications were not provided.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Vaccination site pain
Clinical narrative: I have gastritis which got worse after receiving the vaccine/stomach pain/nauseous/not able to eat; got extreme pain in left shoulder and low back where I have chronic injuries.; still very sick from this vaccine; extreme pain in my right shoulder where I got the injection; also got extreme pain in left shoulder and low back where I have chronic injuries; chills; head ache; This spontaneous case was reported by a patient and describes the occurrence of GASTRITIS (I have gastritis which got worse after receiving the vaccine/stomach pain/nauseous/not able to eat), BACK PAIN (got extreme pain in left shoulder and low back where I have chronic injuries.), MALAISE (still very sick from this vaccine), VACCINATION SITE PAIN (extreme pain in my right shoulder where I got the injection) and ARTHRALGIA (also got extreme pain in left shoulder and low back where I have chronic injuries) in an 80-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 (reaction was worse than when patient caught omicron over a year ago).    On 23-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 23-Sep-2024, the patient experienced GASTRITIS (I have gastritis which got worse after receiving the vaccine/stomach pain/nauseous/not able to eat), BACK PAIN (got extreme pain in left shoulder and low back where I have chronic injuries.), MALAISE (still very sick from this vaccine), VACCINATION SITE PAIN (extreme pain in my right shoulder where I got the injection), ARTHRALGIA (also got extreme pain in left shoulder and low back where I have chronic injuries), CHILLS (chills) and HEADACHE (head ache). At the time of the report, GASTRITIS (I have gastritis which got worse after receiving the vaccine/stomach pain/nauseous/not able to eat), BACK PAIN (got extreme pain in left shoulder and low back where I have chronic injuries.), MALAISE (still very sick from this vaccine), VACCINATION SITE PAIN (extreme pain in my right shoulder where I got the injection), ARTHRALGIA (also got extreme pain in left shoulder and low back where I have chronic injuries), CHILLS (chills) and HEADACHE (head ache) had not resolved.        For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use), the reporter did not provide any causality assessments.   No concomitant medications were reported. Reporter causality was not reported. Patient thinks that he need to take a reduced dose when he get a covid vaccine as he had too strong of a reaction to the dose.  It was unknown if the patient experienced any additional symptoms/events.  Treatment medications were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: last time she took the vaccine as it was in her arm, she felt a pain, as the needle went right down to the painful area of her arm; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (last time she took the vaccine as it was in her arm, she felt a pain, as the needle went right down to the painful area of her arm) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     The patient's past medical history included Accident NOS (she had an accident which affected both her arms) and Arm injury.    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 VACCINATION SITE PAIN (last time she took the vaccine as it was in her arm, she felt a pain, as the needle went right down to the painful area of her arm). At the time of the report, VACCINATION SITE PAIN (last time she took the vaccine as it was in her arm, she felt a pain, as the needle went right down to the painful area of her arm) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown.  It was reported that last time she took the vaccine as it was in her arm, she felt a pain, as the needle went right down to the painful area of her arm. Reporter causality was not reported. Treatment information was not provided   Reporter did not allow further contact
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Soreness, swelling and redness with heat at the site of administration; Soreness, swelling and redness with heat at the site of administration; Soreness, swelling and redness with heat at the site of administration; Soreness, swelling and redness with heat at the site of administration; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE WARMTH (Soreness, swelling and redness with heat at the site of administration), VACCINATION SITE PAIN (Soreness, swelling and redness with heat at the site of administration), VACCINATION SITE SWELLING (Soreness, swelling and redness with heat at the site of administration) and VACCINATION SITE ERYTHEMA (Soreness, swelling and redness with heat at the site of administration) in a 39-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.     No Medical History information was reported.    On 23-Sep-2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Intramuscular use) 1 dosage form. On 24-Sep-2024, the patient experienced VACCINATION SITE WARMTH (Soreness, swelling and redness with heat at the site of administration), VACCINATION SITE PAIN (Soreness, swelling and redness with heat at the site of administration), VACCINATION SITE SWELLING (Soreness, swelling and redness with heat at the site of administration) and VACCINATION SITE ERYTHEMA (Soreness, swelling and redness with heat at the site of administration). At the time of the report, VACCINATION SITE WARMTH (Soreness, swelling and redness with heat at the site of administration), VACCINATION SITE PAIN (Soreness, swelling and redness with heat at the site of administration), VACCINATION SITE SWELLING (Soreness, swelling and redness with heat at the site of administration) and VACCINATION SITE ERYTHEMA (Soreness, swelling and redness with heat at the site of administration) had not resolved.            No concomitant and treatment medication were reported. The patient did not experience any additional symptoms/events. The patient had no medical history, concomitant disease or risk factor. There were no lab data/results available.
Age: 14.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Peripheral swelling, Pruritus, Rash
Clinical narrative: bright red rashes on the hands and feet and it was itchy; bright red rashes on the hands and feet and it was swollen; Rashes on his hands and feet; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRURITUS (bright red rashes on the hands and feet and it was itchy), PERIPHERAL SWELLING (bright red rashes on the hands and feet and it was swollen) and RASH (Rashes on his hands and feet) in a 14-year-old male patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    Previously administered products included for Product used for unknown indication: Pfizer vaccine (Dose 1) on 18-Nov-2021, Pfizer vaccine (Dose 2) on 09-Dec-2021 and Pfizer vaccine (Dose 3) on 09-May-2022. Past adverse reactions to the above products included No adverse effect with Pfizer vaccine, Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included Egg allergy (as a baby but outgrew at 6 years old and eats eggs all the time.).   On 19-Sep-2024, the patient received fourth dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) .5 milliliter and dose of INFLUENZA VACCINE (unknown route) 1 dosage form. On 23-Sep-2024, the patient experienced PRURITUS (bright red rashes on the hands and feet and it was itchy), PERIPHERAL SWELLING (bright red rashes on the hands and feet and it was swollen) and RASH (Rashes on his hands and feet). The patient was treated with CORTISONE (topical) for Itchy, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Itchy, at an unspecified dose and frequency and MAGNESIUM SULFATE (EPSOM SALT) from 24-Sep-2024 to 25-Sep-2024 for Itchy, at an unspecified dose and frequency. At the time of the report, PRURITUS (bright red rashes on the hands and feet and it was itchy), PERIPHERAL SWELLING (bright red rashes on the hands and feet and it was swollen) and RASH (Rashes on his hands and feet) was resolving.            Patient have received other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported. Patient's primary care doctor stated patient took pictures of the affected area as advised and showed it to them.   This case was linked to US-MODERNATX, INC.-MOD-2024-774430 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-774430:Same reporter different patient
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Flushing, Illness, Malaise
Clinical narrative: just was sick; I got very ill; weak; Sick to my stomach; flushed; I got very nauseous; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (just was sick), ILLNESS (I got very ill), ASTHENIA (weak), ABDOMINAL DISCOMFORT (Sick to my stomach) and FLUSHING (flushed) in an 82-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Visual impairment (disability - visually impaired) and COVID-19. Previously administered products included for Product used for unknown indication: COVID-19 VACCINE in November 2023. Past adverse reactions to the above products included No adverse effect with COVID-19 VACCINE.    In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In September 2024, the patient experienced MALAISE (just was sick), ILLNESS (I got very ill), ASTHENIA (weak), FLUSHING (flushed) and NAUSEA (I got very nauseous). September 2024, the patient experienced ABDOMINAL DISCOMFORT (Sick to my stomach). In September 2024, FLUSHING (flushed) had resolved. At the time of the report, MALAISE (just was sick), ILLNESS (I got very ill), ASTHENIA (weak), ABDOMINAL DISCOMFORT (Sick to my stomach) and NAUSEA (I got very nauseous) had not resolved.            The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. The patient had a Moderna shot COVID on September the fourth (patient initially stated 4Sep2024 but also mentioned it could have been 5Sep2024) and about maybe five to six hours later, the patient got very ill and was ill for two weeks and it was the same side effects as when the patient had COVID without the respiratory problem. It's been five weeks, but patient was definitely ill for about two weeks. The patient still didn't feeling that great but not deafly ill like the patient was at the beginning but still feeling nauseous. It was either at 11 or midnight or one o'clock in the morning. But it was, when the patient was in the middle of sleep she woke up and was very ill. So it was either the fourth or the fifth of September. She got the shot about 11:30 in the morning and so it wasn't until the evening, like, probably after 8:08 p.m, the patient got very nauseous and just was sick and in the middle of the night was just sick. Sick to the stomach, nauseous and very, very weak. The patient didn't had a fever but was flushed and that continued on for approximately 2 weeks. it dissipated but still feel nauseous slightly. The patient didn't throw up or anything but just didn't felt it just really strange. Treatment information was not provided.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: just was sick; I got very ill; weak; Sick to my stomach; flushed; I got very nauseous; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (just was sick), ILLNESS (I got very ill), ASTHENIA (weak), ABDOMINAL DISCOMFORT (Sick to my stomach) and FLUSHING (flushed) in an 82-year-old female patient who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Visual impairment (disability - visually impaired) and COVID-19. Previously administered products included for Product used for unknown indication: COVID-19 VACCINE in November 2023. Past adverse reactions to the above products included No adverse effect with COVID-19 VACCINE.    In September 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form. In September 2024, the patient experienced MALAISE (just was sick), ILLNESS (I got very ill), ASTHENIA (weak), FLUSHING (flushed) and NAUSEA (I got very nauseous). September 2024, the patient experienced ABDOMINAL DISCOMFORT (Sick to my stomach). In September 2024, FLUSHING (flushed) had resolved. At the time of the report, MALAISE (just was sick), ILLNESS (I got very ill), ASTHENIA (weak), ABDOMINAL DISCOMFORT (Sick to my stomach) and NAUSEA (I got very nauseous) had not resolved.            The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant product use was not provided by the reporter. Suspect vaccine dosage text was reported as unknown. The patient had a Moderna shot COVID on September the fourth (patient initially stated 4Sep2024 but also mentioned it could have been 5Sep2024) and about maybe five to six hours later, the patient got very ill and was ill for two weeks and it was the same side effects as when the patient had COVID without the respiratory problem. It's been five weeks, but patient was definitely ill for about two weeks. The patient still didn't feeling that great but not deafly ill like the patient was at the beginning but still feeling nauseous. It was either at 11 or midnight or one o'clock in the morning. But it was, when the patient was in the middle of sleep she woke up and was very ill. So it was either the fourth or the fifth of September. She got the shot about 11:30 in the morning and so it wasn't until the evening, like, probably after 8:08 p.m, the patient got very nauseous and just was sick and in the middle of the night was just sick. Sick to the stomach, nauseous and very, very weak. The patient didn't had a fever but was flushed and that continued on for approximately 2 weeks. it dissipated but still feel nauseous slightly. The patient didn't throw up or anything but just didn't felt it just really strange. Treatment information was not provided.