chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE/PQC; inadvertent administration of an extra dose of GARDASIL 9 to a 16-year-old patient who already completed the two-dose regimen of GARDASIL 9.; This spontaneous report was received from a nurse and refers to a 16-year-old patient.  The patient's medical history, concurrent conditions, previous drugs reactions or allergies and concomitant therapies were not reported.  On an unknown date in 2020, when the patient had approximately 14 years old, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, at a dose of  0.5ml  (strength, lot #, expiry date, and route of administration were not provided), on an unknown date in 2021, the patient received the 2nd dose at a dose of 0,5ml (strength, lot #, expiry date, and route of administration were not provided); on 14-NOV-2024, at the age of 16 years old, the patient inadvertent received an extra dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) at a dose of 0.5ml  (strength, lot #, expiry date, and route of administration were not provided) when the patient  already completed the two-dose regimen (extra dose administered); all doses as prophylaxis. No additional adverse event was reported.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: The patient received first dose of Jynneos intramuscularly instead subcutaneously; Case reference number US-BN-2024-002635 is a spontaneous case initially received from pharmacist via Communications (reference number: USBAV24-2676) on 10-Oct-2024 and concerns a patient of unspecified age and gender.  The patient's medical history and concomitant medication details were not provided.  On an unspecified date, the patient was vaccinated with a first dose of Jynneos (batch number: unknown), at an unknown dose, intramuscularly, on the arm for unknown indication (explicitly coded as 'incorrect route of product administration').  On 09-Oct-2024, reported as yesterday, unknow amount of time after the first dose, the patient was vaccinated with the second dose of Jynneos (batch number: unknown), an unknown dose, subcutaneously at unknown site of administration.  At the time of the initial report, it was unknown if the patient experienced any adverse event due to the Jynneos vaccination.  No further information was provided.; Reporter's Comments: A patient of unspecified age and gender was vaccinated with a first dose of Jynneos, at an unknown dose, intramuscularly, on the arm for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to the Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unspecified age and gender was vaccinated with a first dose of Jynneos, at an unknown dose, intramuscularly, on the arm for unknown indication which is considered as inappropriate route of vaccination. Incorrect route of product administration is considered listed per company convention. At this point, it was unknown if the patient experienced any adverse event due to the Jynneos vaccination. The patient's medical history and concomitant medication details were not provided. Causality is assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: The patient received first and second dose of Jynneos intramuscularly instead of subcutaneously; Case reference number US-BN-2024-002659 is a spontaneous case initially received from a pharmacist via Communications (reference number: USBAV24-2749) on 17-Oct-2024 and concerns a 20-year-old patient of unspecified gender.  The patient's medical history and concomitant medication details were not provided.  On 11-Sep-2024, the patient was vaccinated with the first dose of Jynneos (batch number: unknown), at an unknown dose or site of administration, intramuscularly, for unknown indication (explicitly coded as 'inappropriate route of vaccination').  On 09-Oct-2024, 28 days after vaccination with first dose of Jynneos vaccine, the patient was vaccinated with the second dose of Jynneos (batch number: unknown at an unknown dose or site of administration, intramuscularly (explicitly coded as 'inappropriate route of vaccination').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine.  No further information was provided.; Reporter's Comments: A 20-year-old patient of unspecified gender was vaccinated with the first and with the second dose of Jynneos, intramuscularly, for unknown indication, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to Jynneos vaccine. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A 20-year-old patient of unspecified gender was vaccinated with the first and with the second dose of Jynneos, intramuscularly, for unknown indication, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to Jynneos vaccine. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Product storage error
Clinical narrative: Patient received one dose of Jynneos, when the vaccine was placed from the fridge to the freezer and removed from freezer; Patient received one dose of Jynneos, when the vaccine was placed from the fridge to the freezer and removed from freezer; Case reference number US-BN-2024-002672 is a spontaneous case initially received from nurse via agency (reference number: USBAV24-2789) on 22-Oct-2024 and concerns a male patient of unknown age.  The patient's medical history and concomitant medication details were not provided.  As reported vaccines were received at 40-degree Fahrenheit, as soon as they arrived, they were placed in the freezer. The vials were placed in the freezer from 09-Oct-2024 to 18-Oct-2024. On the 18-Oct-2024, the same vials were removed from the freezer and placed in the fridge.   On unspecified date, the patient received one dose of Jynneos (batch number: unknown) at an unknown dose, route and site of administration for unknown indication, when the vaccine was placed from the fridge to the freezer (explicitly coded as 'product storage error' and 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos.  No further information was provided.; Reporter's Comments: A male patient was vaccinated with a dose of Jynneos, which had been received at a temperature of 40 deg F (approximately 4.44 deg C), subsequently stored in a freezer for 9 days, and then placed in a fridge. This is considered product storage error and product administration error, which are listed special situations as per company convention. No associated adverse events were reported. Medical history was unknown. Product storage error and product administration error are not related to Jynneos, but to technical error. The case is non-serious.; Sender's Comments: A male patient was vaccinated with a dose of Jynneos, which had been received at a temperature of 40 deg F (approximately 4.44 deg C), subsequently stored in a freezer for 9 days, and then placed in a fridge. This is considered product storage error and product administration error, which are listed special situations as per company convention. No associated adverse events were reported. Medical history was unknown. Product storage error and product administration error are not related to Jynneos, but to technical error. The case is non-serious.
Sex: U
Vaccine: SMALLMNK
Symptoms: Product storage error
Clinical narrative: The JYNNEOS vaccine was given after being held at two to eight degree Celsius for five weeks and according to new package insert it could be held at two to eight degree Celsius for four weeks.; The JYNNEOS vaccine was given after being held at two to eight degree Celsius for five weeks and according to new package insert it could be held at two to eight degree Celsius for four weeks.; Case reference number US-BN-2024-002733 is a spontaneous case initially received from a consumer via agency(reference number: USBAV24-2909) on 04-Nov-2024 and concerns a patient of unknown gender and age.  The patient's medical history and concomitant medication details were not provided.  On unspecified date, the patient was vaccinated with a dose of Jynneos (batch number: unknown), at an unknown dose, route or site of administration, for unknown indication. As reported, the Jynneos vaccine was given after being held at two to eight degrees Celsius for five weeks and according to new package insert it could be held at two to eight degrees Celsius for four weeks (explicitly coded as 'product storage error' and 'product administration error').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos.  No further information was provided.; Reporter's Comments: A patient of unknown gender and age was vaccinated with a dose of Jynneos, at an unknown dose, route or site of administration, for unknown indication. Reportedly, the Jynneos vaccine was given after being held at two to eight degrees Celsius for five weeks and according to new package insert it could be held at two to eight degrees Celsius for four weeks which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.; Sender's Comments: A patient of unknown gender and age was vaccinated with a dose of Jynneos, at an unknown dose, route or site of administration, for unknown indication. Reportedly, the Jynneos vaccine was given after being held at two to eight degrees Celsius for five weeks and according to new package insert it could be held at two to eight degrees Celsius for four weeks which is considered as product storage error and product administration error. Product storage error and product administration error are both considered listed per company conventions. At this point, it was unknown if the patient experienced any adverse event due to Jynneos. The patient's medical history and concomitant medication details were not provided. Product storage error and product administration error are both assessed as not related to suspect product but to human factor. The case is non-serious.
Sex: M
Vaccine: SMALLMNK
Symptoms: Incorrect route of product administration
Clinical narrative: The patient recieved first dose of Jynneos vaccine intramuscularly; Case reference number US-BN-2024-002741 is a spontaneous case initially received from other health care professional via agency (reference number: USBAV24-2932) on 06-Nov-2024 and concerns a male patient of unspecified age.   The patient's medical history and concomitant medication details were not provided.  On 06-Nov-2024, the patient was vaccinated with a first dose of Jynneos (batch number: unknown and expiration date: unknown), at an unknown dose, intramuscularly at unknown site of administration, for an unknown indication (explicitly coded as 'inappropriate route of vaccination').  At the time of the initial report, it was unknown if the patient experienced any adverse event due to Jynneos vaccine.   No further information was provided.; Reporter's Comments: A male patient of unspecified age was vaccinated with the first dose of Jynneos, intramuscularly, for an unknown indication, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to Jynneos vaccine. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.; Sender's Comments: A male patient of unspecified age was vaccinated with the first dose of Jynneos, intramuscularly, for an unknown indication, which is considered as inappropriate route of vaccination. It was unknown if the patient experienced any adverse event due to Jynneos vaccine. Incorrect route of product administration is considered as listed per company convention. The patient's medical history and concomitant medication details were not provided. Incorrect route of product administration is not related to the suspect vaccine, but to a human factor. This case is considered as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered, No adverse event
Clinical narrative: I Received HEPLISAV-B in October Last Year, and then I Got the Second Dose In Nov-2024; Initial report received on 01-Nov-2024.  A consumer reported that she, a female (age, race, and ethnicity not provided), received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization in Oct- 2023 and received the second dose on 01-Nov-2024.  No relevant medical history or concomitant medications were reported.    In Oct-2023, the patient received the first dose of a hepatitis B vaccine [HEPLISAV-B (lot number, expiration date, NDC number, route, and site not reported)].  On 01-Nov-2024, the patient received the second dose of HEPLISAV-B (lot number, expiration date, and NDC number not reported) intramuscularly. The patient called medical information to see if she needed to receive another dose of HEPLISAV-B.  No adverse events were reported.    No additional information was provided.    Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness, Insomnia
Clinical narrative: Had flu like symptoms after the 2nd one; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of influenza-like symptoms in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st dose on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced influenza-like symptoms (Verbatim: Had flu like symptoms after the 2nd one). The outcome of the influenza-like symptoms was not reported.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingles vaccine.     It was unknown if the company considered the influenza-like symptoms to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 21-OCT-2024 The case was received from the patient via interactive digital media. The patient received Shingles vaccine. The reporter reported that his/her dad did not sleep through the night for 6 weeks when he got shingles. He was up and down every night, all night. After seeing what he went through the patient got the shots. The patient had flu like symptoms after the 2nd one, but the patient figure it was a small price to pay. 5 years later, and so far so good, no shingles.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: No 2nd dose due to COVID pandemics, 1st dose in FEB2020; This non-serious case was reported by a consumer via call center representative and described the occurrence of social problem in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose in FEB-2020).   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 social problem (Verbatim: No 2nd dose due to COVID pandemics, 1st dose in FEB2020). The outcome of the social problem was unknown.   Additional Information: GSK receipt date: 26-OCT-2024 The patient received his/her first dose of Shingrix in February 2020. Then Covid happened and, with all that was going on, he/she completely forgot about getting the second dose. The reporter asked questioned did he/she start the series again given it had been almost 5 years or did he/she just need to get the second dose.
Sex: U
Vaccine: RVX
Symptoms: Illness, Respiratory disorder
Clinical narrative: respiratory issues/Finally getting over respiratory issues; Sicker; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of respiratory disorder 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 respiratory disorder (Verbatim: respiratory issues/Finally getting over respiratory issues) and sickness (Verbatim: Sicker). The outcome of the respiratory disorder was resolving and the outcome of the sickness was not reported.   It was unknown if the reporter considered the respiratory disorder and sickness to be related to RSV vaccine.     It was unknown if the company considered the respiratory disorder and sickness to be related to RSV vaccine.   Additional Information: GSK receipt date: 31-OCT-2024 The patient had respiratory syncytial virus vaccine and the patient was sicker been in a long time. The patient reported his/her respiratory issues was finally getting over.
Sex: U
Vaccine: RSV
Symptoms: Back pain, Breast pain, Injection site pain
Clinical narrative: Pain at injection site left arm; Pain at injection site left arm & breast & back; Pain at injection site left arm & breast & back; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy (left arm). On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: Pain at injection site left arm), breast pain (Verbatim: Pain at injection site left arm & breast & back) and back pain (Verbatim: Pain at injection site left arm & breast & back). The outcome of the injection site pain, breast pain and back pain were not reported.   It was unknown if the reporter considered the injection site pain, breast pain and back pain to be related to Arexvy.     It was unknown if the company considered the injection site pain, breast pain and back pain to be related to Arexvy.   Additional Information: GSK receipt date: 30-OCT-2024 This case was reported by a patient via interactive digital media. Reporter reported the pain at injection site left arm, breast & back. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: RSV
Symptoms: Hypertension
Clinical narrative: hypertension; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of hypertension in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced hypertension (Verbatim: hypertension). The outcome of the hypertension was not reported.   It was unknown if the reporter considered the hypertension to be related to Arexvy.     It was unknown if the company considered the hypertension to be related to Arexvy.   Additional Information: GSK receipt date: 31-OCT-2024 This case was reported by a patient via interactive digital media. The patient self reported this case he/she reported that he/she received Arexvy vaccine and after vaccination patient experienced hypertension.
Sex: U
Vaccine: RSV
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Pain
Clinical narrative: Can't move left vaccinated arm over my left shoulder/can't sleep on my left; hurts to tie my shoe or to button buttons; Can't move my left vaccinated arm over my left shoulder/hurts to tie my shoe/; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injected limb mobility decreased in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injected limb mobility decreased (Verbatim: Can't move left vaccinated arm over my left shoulder/can't sleep on my left), pain (Verbatim: hurts to tie my shoe or to button buttons) and activities of daily living impaired (Verbatim: Can't move my left vaccinated arm over my left shoulder/hurts to tie my shoe/). The outcome of the injected limb mobility decreased, pain and activities of daily living impaired were not reported.   It was unknown if the reporter considered the injected limb mobility decreased, pain and activities of daily living impaired to be related to Arexvy.     It was unknown if the company considered the injected limb mobility decreased, pain and activities of daily living impaired to be related to Arexvy.   Additional Information: GSK receipt date: 31-OCT-2024 The patient reported he/ she could not move left vaccinated arm over left shoulder, could not sleep on left for more couple of hours. The reporter reported hurts to tie shoe or to button. Not real easy to put shorts.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Oral herpes zoster, Vaccination failure
Clinical narrative: Suspected Vaccination Failure; shingles in my mouth; Shingles; 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 (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Varicella zoster vaccine (I had the original vaccine in 2016).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Suspected Vaccination Failure) (serious criteria GSK medically significant), oral herpes zoster (Verbatim: shingles in my mouth) and shingles (Verbatim: Shingles). The outcome of the vaccination failure and shingles were not reported and the outcome of the oral herpes zoster was resolved.   It was unknown if the reporter considered the vaccination failure, oral herpes zoster and shingles to be related to Shingles vaccine and Shingles vaccine.     The company considered the vaccination failure to be unrelated to Shingles vaccine and Shingles vaccine. It was unknown if the company considered the oral herpes zoster and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 10-NOV-2024 The reporter reported that he/she had shingles in his/her mouth for the last 7 weeks.  It had been a living hell. He/she had the original vaccine in 2016 and the newer double vaccine in 2022.  He/she still got shingles. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.; Sender's Comments: Vaccination failure is a listed event which, due to the following criteria (insufficient information provided about details regarding time to onset for shingles and laboratory confirmation regarding shingles) is considered unrelated to GSK vaccine Shingrix(Dose 1 and 2).
Sex: F
Vaccine: RSV
Symptoms: Headache, Pain in extremity
Clinical narrative: arm  pounding where vaccine was administered; tremendous headache; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 19-OCT-2024, the patient received the 1st dose of Arexvy. In OCT-2024, less than a week after receiving Arexvy, the patient experienced pain in arm (Verbatim: arm  pounding where vaccine was administered) and headache (Verbatim: tremendous headache). The outcome of the pain in arm and headache were unknown.   It was unknown if the reporter considered the pain in arm and headache to be related to Arexvy.     It was unknown if the company considered the pain in arm and headache to be related to Arexvy.   Additional Information: GSK Receipt Date: 23-OCT-2024 Consumer was the reporter who stated that she had Arexvy administered on 19th October 2024. Consumer stated that she had a tremendous headache and her arm was pounding where she received the vaccine. Her head hurted mostly on the same side as the vaccine was injected. She was taking Tylenol, which was not helping the headache, and applying ice to her arm for the pain. No further information was known including date of birth, demographics.
Age: 25.0
Sex: F
Vaccine: RSV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Arexvy was administered to a 25 year old patient; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 25-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: Arexvy was administered to a 25 year old patient). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 29-OCT-2024 Healthcare professional reported Arexvy was administered to a 25 year old patient which led to inappropriate age at vaccine administration.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: swelling at the injection site; pain at the injection site; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 4BN95, expiry date 26-OCT-2024) for prophylaxis.   On 16-OCT-2024, the patient received the 1st dose of Arexvy (intramuscular, left deltoid). On 16-OCT-2024, less than a day after receiving Arexvy, the patient experienced injection site swelling (Verbatim: swelling at the injection site) and injection site pain (Verbatim: pain at the injection site). The outcome of the injection site swelling and injection site pain were not resolved.   It was unknown if the reporter considered the injection site swelling and injection site pain to be related to Arexvy.     It was unknown if the company considered the injection site swelling and injection site pain to be related to Arexvy.   Additional Information: GSK receipt date: 29-OCT-2024 The reporter called on behalf of the patient that the patient had received the Arexvy vaccine and experienced pain and swelling at the injection site.
Sex: F
Vaccine: CHIK
Symptoms: Pain, Pyrexia
Clinical narrative: Temperature of 101.5 F (38.6 degree Celsius); She was aching all over; The following information was received from a consumers husband on 14 Sep 2024.  A female of unknown age received one dose of IXCHIQ (Chikungunya virus vaccination(CHIKV), batch number not provided) on an unknown date.  On an unknown date she experienced temperature of 101.5 F (38.6 degree Celsius) and it was reported that she was aching all over.  An outcome was not provided.; Sender's Comments: Causality assessed as possibly related as Pyrexia and Generalized pain (most likely in the sense of muscle pain) is well known for IXCHIQ, indicative of a systemic vaccination reaction. Due to the lack of more information, a detailed assessment is not possible at the moment.
Sex: F
Vaccine: CHIK
Symptoms: Arthralgia, Headache, Malaise, Myalgia
Clinical narrative: Joint/muscle pain; Joint/muscle pain; Headache; General malaise; The following information was received from a nurse on 17 Oct 2024.  A female vaccinee received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV), batch number not reported) on an unknown date.   Four days after vaccination she experienced joint and muscle pain, headache, general malaise and she felt ill.  The events lasted for two days.  This case is linked with case US-INTERCELLP-6523 (husband with same events); Sender's Comments: Causality assessed as possibly related, as time to onset is plausible (4 days past vaccination) and as all events are well known for IXCHIQ, also Malaise by medical concept of feeling ill/abnormal/unwell, indicative of a systemic vaccination reaction. Confounding factors were not reported.
Sex: M
Vaccine: CHIK
Symptoms: Arthralgia, Headache, Malaise, Myalgia
Clinical narrative: Joint/muscle pain; Joint/muscle pain; Headache; General malaise; The following information was received from a nurse on 17 Oct 2024.  A male vaccinee received one dose of IXCHIQ (prevention of disease caused by chikungunya virus (CHIKV), batch number not reported) on an not reported date.   Four days after vaccination he experienced joint and muscle pain, headache, general malaise and he felt ill.  The events lasted for two days.  This case is linked with case US-INTERCELLP-6522 (wife with same events); Sender's Comments: Causality assessed as possibly related, as time to onset is plausible (4 days past vaccination) and as all events are well known for IXCHIQ, also Malaise by medical concept of feeling ill/abnormal/unwell, indicative of a systemic vaccination reaction. Confounding factors were not reported.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: general aches and pains.; fever; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PAIN (general aches and pains.) and PYREXIA (fever) in an 81-year-old female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fifth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, received fourth dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, third dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form, second dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form and first dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (general aches and pains.) and PYREXIA (fever). At the time of the report, PAIN (general aches and pains.) and PYREXIA (fever) outcome was unknown.            No concomitant medications were provided. Patient had received 5 prior dose of Moderna Covid-19 vaccine and/booster since 2021. She typically had fever, general aches and pains following each dose. No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2024-776825 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 08-Nov-2024: Significant follow-up received. Updated suspect product from Unspecified vaccine to Spikevax NOS. Deleted the classification of invalid. Action taken for suspect product updated from unknown to not applicable. Updated reporter occupation. Updated narrative.; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-776825:Master case
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pains; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pains) in an elderly patient of an unknown 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pains). At the time of the report, CHEST PAIN (chest pains) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medication was reported.  Patient experienced chest pains after receiving COVID vaccine. It was unknown if the patient experienced any additional symptoms/events.  No treatment medication was reported.  This case contains information for the 2nd of 3 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-776965 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-776965:Patient 2
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: chest pains; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pains) in an elderly patient of an unknown 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (chest pains). At the time of the report, CHEST PAIN (chest pains) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.       No concomitant medication was reported.  Patients experienced chest pains after receiving COVID vaccine. It was unknown if the patient experienced any additional symptoms/events.  No treatment medication was reported.  This case contains information for the 3rd of 3 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-776965 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-776965:Patient 3
Sex: U
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Chest pains; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pains) in an elderly patient of an unknown 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) (Intramuscular use) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pains). At the time of the report, CHEST PAIN (Chest pains) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Intramuscular use) was unknown.     No concomitant medications were reported. Reporter causality was not provided. It was reported that the patient experienced chest pains after receiving the COVID vaccine.  It was unknown if the patient experienced any additional symptoms/events.  No treatment medications were reported.  This case contains information for the 01 of 03 patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2024-776971, US-MODERNATX, INC.-MOD-2024-776977 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-776971:Patient 2 US-MODERNATX, INC.-MOD-2024-776977:Patient 3
Age: 55.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Body temperature, Chills, Fatigue, Headache, Myalgia
Clinical narrative: myalgia; fever; chills; exhaustion; headache; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (myalgia), PYREXIA (fever), CHILLS (chills), FATIGUE (exhaustion) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine inact split 3v (Fluarix) for an unknown indication.    Concurrent medical conditions included Lupus vulgaris, SLE (Lupus (SLE)), Hashimoto's disease, Sjogren's syndrome and Asthma.   In November 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and dose of Influenza vaccine inact split 3v (Fluarix) (unknown route) 1 dosage form. In November 2024, the patient experienced MYALGIA (myalgia). November 2024, the patient experienced PYREXIA (fever), CHILLS (chills), FATIGUE (exhaustion) and HEADACHE (headache). The patient was treated with Paracetamol (Tylenol) (oral use) in November 2024 for Fever, at a dose of Acetaminophen - 2 doses of Extra Strength Tylenol. In November 2024, PYREXIA (fever), CHILLS (chills), FATIGUE (exhaustion) and HEADACHE (headache) had resolved. At the time of the report, MYALGIA (myalgia) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2024, Body temperature: 103.1 degrees.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Day after administration of both Spikevax and Fluarix, patient had a fever of 103.1 degrees, chills, exhaustion and a terrible headache. Symptoms resolved within 24 hours with treatment with acetaminophen. Day 2 following administration, patient had full-body myalgia. Second medication name was unknown.  The patient did not experience any additional symptoms/events. The patient did not have any additional medical history, concomitant disease, or risk factor.
Age: 55.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Pyrexia
Clinical narrative: myalgia; fever; chills; exhaustion; headache; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (myalgia), PYREXIA (fever), CHILLS (chills), FATIGUE (exhaustion) and HEADACHE (headache) in a female patient of an unknown age who received mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) for COVID-19 prophylaxis.    Co-suspect product included non-company product Influenza vaccine inact split 3v (Fluarix) for an unknown indication.    Concurrent medical conditions included Lupus vulgaris, SLE (Lupus (SLE)), Hashimoto's disease, Sjogren's syndrome and Asthma.   In November 2024, the patient received dose of mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (unknown route) 1 dosage form and dose of Influenza vaccine inact split 3v (Fluarix) (unknown route) 1 dosage form. In November 2024, the patient experienced MYALGIA (myalgia). November 2024, the patient experienced PYREXIA (fever), CHILLS (chills), FATIGUE (exhaustion) and HEADACHE (headache). The patient was treated with Paracetamol (Tylenol) (oral use) in November 2024 for Fever, at a dose of Acetaminophen - 2 doses of Extra Strength Tylenol. In November 2024, PYREXIA (fever), CHILLS (chills), FATIGUE (exhaustion) and HEADACHE (headache) had resolved. At the time of the report, MYALGIA (myalgia) was resolving.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Nov-2024, Body temperature: 103.1 degrees.     For mRNA-1273.712 (SPIKEVAX 2024-2025 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  Day after administration of both Spikevax and Fluarix, patient had a fever of 103.1 degrees, chills, exhaustion and a terrible headache. Symptoms resolved within 24 hours with treatment with acetaminophen. Day 2 following administration, patient had full-body myalgia. Second medication name was unknown.  The patient did not experience any additional symptoms/events. The patient did not have any additional medical history, concomitant disease, or risk factor.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis, Tinnitus
Clinical narrative: Hearing Loss: Left ear has ringing, feels full and is significantly reduced normal hearing ability in that ear. Estimate that hearing  is reduced to only 30-40% of my normal hearing ability. Cleaned ear after realizing issue this morning and was unable to recover hearing by popping ears by yawning, blowing nose etc. Only a very small amount of residual wax was removed when I cleaned them.
Age: 42.0
Sex: F
Vaccine: COVID19, FLU3
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Child given adult Covid dose instead of child dose
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Back pain, Decreased appetite, Diarrhoea, Disorientation
Clinical narrative: Approx. 12 hrs. Later I could not sleep. I had a headache, my neck was spasming and my lower back hurt. In the morning, I was very fatigued with a headache and body aches. This progressed through out the day and by the evening I was dizzy, stumbling and felt very disoriented. I hurt all over and could not get get rid of my headache and pain. This has continued through today though I was able to eat last night for the first time and the diarrhea has stopped as of today. I am still very fatigued with stomach cramping.  I was given Zofran and Prednisone via my doctor and took Tylenol every 8 -10 hours.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Gait disturbance, Headache, Insomnia
Clinical narrative: Approx. 12 hrs. Later I could not sleep. I had a headache, my neck was spasming and my lower back hurt. In the morning, I was very fatigued with a headache and body aches. This progressed through out the day and by the evening I was dizzy, stumbling and felt very disoriented. I hurt all over and could not get get rid of my headache and pain. This has continued through today though I was able to eat last night for the first time and the diarrhea has stopped as of today. I am still very fatigued with stomach cramping.  I was given Zofran and Prednisone via my doctor and took Tylenol every 8 -10 hours.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Pain, SARS-CoV-2 test negative
Clinical narrative: Approx. 12 hrs. Later I could not sleep. I had a headache, my neck was spasming and my lower back hurt. In the morning, I was very fatigued with a headache and body aches. This progressed through out the day and by the evening I was dizzy, stumbling and felt very disoriented. I hurt all over and could not get get rid of my headache and pain. This has continued through today though I was able to eat last night for the first time and the diarrhea has stopped as of today. I am still very fatigued with stomach cramping.  I was given Zofran and Prednisone via my doctor and took Tylenol every 8 -10 hours.
Age: 1.25
Sex: F
Vaccine: DTAPIPV, FLU3
Symptoms: Extra dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: There was no adverse event reported for this vaccine.   Dtap was ordered and child received Kinrix. Child received an extra dose of polio.   No adverse event occurred.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis, Chills, Fatigue, Full blood count normal, Hyperhidrosis
Clinical narrative: Started with flu-like symptoms within hours of the vaccine on 11/12/24 (fatigue, body aches). By the next day,  By 24 hours after the vaccine, the injection site was severely red, hot, swollen and painful and she was experiencing sweats, chills, severe fatigue/malaise. She went to the ER on day 4 (11/16/24) due to no improvement of flu-like symptoms and redness/swelling extending down her arm. ER gave her a diagnosis of cellulitis and provided 2g Rocephin IV in the ER. ER discharged her to home and prescribed oral Keflex and Doxycycline x 10 days.  She was seen by PCP for follow-up on 11/18/24. She reported compliance with prescribed medications and still reported having severe fatigue, sweats, chills, pain in the arm, but the redness/swelling had improved slightly. She as advised to add Tylenol 650mg q4-6 hours as needed for fevers, pain, body aches.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Influenza like illness, Influenza virus test negative, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Started with flu-like symptoms within hours of the vaccine on 11/12/24 (fatigue, body aches). By the next day,  By 24 hours after the vaccine, the injection site was severely red, hot, swollen and painful and she was experiencing sweats, chills, severe fatigue/malaise. She went to the ER on day 4 (11/16/24) due to no improvement of flu-like symptoms and redness/swelling extending down her arm. ER gave her a diagnosis of cellulitis and provided 2g Rocephin IV in the ER. ER discharged her to home and prescribed oral Keflex and Doxycycline x 10 days.  She was seen by PCP for follow-up on 11/18/24. She reported compliance with prescribed medications and still reported having severe fatigue, sweats, chills, pain in the arm, but the redness/swelling had improved slightly. She as advised to add Tylenol 650mg q4-6 hours as needed for fevers, pain, body aches.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: Injection site warmth, Malaise, Metabolic function test normal, Pain, Pain in extremity
Clinical narrative: Started with flu-like symptoms within hours of the vaccine on 11/12/24 (fatigue, body aches). By the next day,  By 24 hours after the vaccine, the injection site was severely red, hot, swollen and painful and she was experiencing sweats, chills, severe fatigue/malaise. She went to the ER on day 4 (11/16/24) due to no improvement of flu-like symptoms and redness/swelling extending down her arm. ER gave her a diagnosis of cellulitis and provided 2g Rocephin IV in the ER. ER discharged her to home and prescribed oral Keflex and Doxycycline x 10 days.  She was seen by PCP for follow-up on 11/18/24. She reported compliance with prescribed medications and still reported having severe fatigue, sweats, chills, pain in the arm, but the redness/swelling had improved slightly. She as advised to add Tylenol 650mg q4-6 hours as needed for fevers, pain, body aches.
Age: 56.0
Sex: F
Vaccine: PNC20
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Started with flu-like symptoms within hours of the vaccine on 11/12/24 (fatigue, body aches). By the next day,  By 24 hours after the vaccine, the injection site was severely red, hot, swollen and painful and she was experiencing sweats, chills, severe fatigue/malaise. She went to the ER on day 4 (11/16/24) due to no improvement of flu-like symptoms and redness/swelling extending down her arm. ER gave her a diagnosis of cellulitis and provided 2g Rocephin IV in the ER. ER discharged her to home and prescribed oral Keflex and Doxycycline x 10 days.  She was seen by PCP for follow-up on 11/18/24. She reported compliance with prescribed medications and still reported having severe fatigue, sweats, chills, pain in the arm, but the redness/swelling had improved slightly. She as advised to add Tylenol 650mg q4-6 hours as needed for fevers, pain, body aches.
Age: 55.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Malaise
Clinical narrative: I don?t think it was adverse event. I am just sick and the questions were about my symptoms.
Age: 62.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia
Clinical narrative: Severe joint pain all over for 2 weeks