chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: Extreme fatigue; This non-serious case was reported by a consumer and described the occurrence of fatigue in a 50-year-old female 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 fatigue (Verbatim: Extreme fatigue). The outcome of the fatigue was resolved.   It was unknown if the reporter considered the fatigue to be related to Shingrix.     It was unknown if the company considered the fatigue to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-MAR-2023 The reporter was patient itself. The patient was non-healthcare professional. This report was submitted via the online direct entry reporting system.  The event extreme fatigue was not treated. The reporter consented to follow up. The vaccination start date was 19th October 2019 and end date was 27th August 2021 however only one suspect was coded in the case with no vaccination date and dose number. As dose numbers was not clearly mentioned for the reported start and end date of the vaccine administration thus we could not assume if the end date was second dose of Shingrix. Also the onset date was not given in the source document and as it was not clear after which dose fatigue was occurred the suspect was retained only in one case. The drug dose administration interval too long was not considered as it was not stated how many doses of Shingrix patient had received in between as no dose number reference was provided.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Site pain to the arm; Erythema; This non-serious case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22-JUN-2022, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced injection site pain (Verbatim: Site pain to the arm) and injection site erythema (Verbatim: Erythema). The outcome of the injection site pain and injection site erythema were not reported.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.     It was unknown if the company considered the injection site pain and injection site erythema to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-MAR-2023 Patient had a wellness visit on 13-MAR-2023 and reported to erythema and site pain to the arm (unknown which arm). Patient received 1st and only dose of Shingrix at local drugstore so lot number, expiration date and other data is unknown to staff. Phone number for store was as stated above, was open to GlaxoSmithKline follow-up via email but data reported here was all they had to submit.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Second shot kicked my butt; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of feeling unwell in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles (patient's father had shingles).   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 feeling unwell (Verbatim: Second shot kicked my butt). The outcome of the feeling unwell was resolved (duration 18 hrs).   It was unknown if the reporter considered the feeling unwell to be related to Shingles vaccine.   It was unknown if the company considered the feeling unwell to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The reporter stated that no idea but he/she would said the shingles shot kicked his/her butt for about 18 hours. The reporter further stated that still better than witnessing his/her father had shingles. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: Sore arm; Some aches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Flu vaccine with an associated reaction of pain in extremity (received on an unknown date, refer linked case US2023AMR049564). Family history included shingles (grandmother).   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Sore arm) and pain (Verbatim: Some aches). The outcome of the pain in arm and pain were resolved.   It was unknown if the reporter considered the pain in arm and pain to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm and pain to be related to Shingles vaccine.   Linked case(s) involving the same patient:  US2023AMR049564   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine after hearing the horror stories about the shingles and he or she pray for anyone who had or has the shingles. The patient stated that his or her grandmother had shingles and it took 3 months to fully recover from it and the pain was unbearable. The patient stated that go and get the shingles vaccine it was just like getting a flu vaccine sore arm and some aches for a day we shall worth from the vaccine. Follow-up would not possible as no contact details were available.; Sender's Comments:  US-GSK-US2023AMR049564:Same reporter
Sex: U
Vaccine: FLUX
Symptoms: Pain, Pain in extremity
Clinical narrative: sore arm; some aches; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Flu unspecified (Flu vaccine) for prophylaxis.   Family history included shingles (grandmother had shingles).   On an unknown date, the patient received Flu vaccine. On an unknown date, an unknown time after receiving Flu vaccine, the patient experienced pain in arm (Verbatim: sore arm) and pain (Verbatim: some aches). The outcome of the pain in arm and pain were resolved.   It was unknown if the reporter considered the pain in arm and pain to be related to Flu vaccine.     It was unknown if the company considered the pain in arm and pain to be related to Flu vaccine.   Linked case(s) involving the same patient:  US2023AMR049524   Additional Information: GSK Receipt Date: 15-MAR-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she received Shingles vaccine after hearing the horror stories about the shingles and he or she pray for anyone who had or has the shingles. The patient stated that his or her grandmother had shingles and it took 3 months to fully recover from it and the pain was unbearable. The patient stated that go and get the shingles vaccine it was just like getting a flu vaccine sore arm and some aches for a day we shall worth from the vaccine. Follow-up would not possible as no contact details were available. This case is linked with US2023AMR049524, reported by same reporter.; Sender's Comments:  US-GSK-US2023AMR049524:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Alanine aminotransferase increased, Blood test abnormal, Hepatic enzyme increased
Clinical narrative: Elevate your liver enzymes; ALT (Alanine transaminase) was high or elevated; This non-serious case was reported by a consumer via call center representative and described the occurrence of elevated liver enzymes in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced elevated liver enzymes (Verbatim: Elevate your liver enzymes) and alanine aminotransferase increased (Verbatim: ALT (Alanine transaminase) was high or elevated). The outcome of the elevated liver enzymes and alanine aminotransferase increased were unknown.   It was unknown if the reporter considered the elevated liver enzymes and alanine aminotransferase increased to be related to Shingrix.     It was unknown if the company considered the elevated liver enzymes and alanine aminotransferase increased to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-MAR-2023 The case was reported to GSK via interactive digitial media regarding Shingrix. The reporter was the patient.  Patient asked GlaxoSmithKline that could vaccine elevate liver enzymes. While outbound call was made to answer the question, patient indicated that she had the second dose of Shingrix and then had blood work done which showed that her Liver function enzymes (LFT-Liver Function Test)  specifically ALT (Alanine transaminase) high/elevated.  The reporter consented to follow up but did not provided her email address.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Cardiac stress test, Formication, Inappropriate schedule of product administration, Paraesthesia
Clinical narrative: Tingling on shoulder and arm; 1st dose in 2019, 2nd in 2023; This non-serious case was reported by a consumer via call center representative and described the occurrence of tingling of extremity in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2019). Concurrent medical conditions included carpal tunnel syndrome.   In FEB-2023, the patient received the 2nd dose of Shingrix (right side). In FEB-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose in 2019, 2nd in 2023). On an unknown date, the patient experienced tingling of extremity (Verbatim: Tingling on shoulder and arm). The outcome of the tingling of extremity was not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the tingling of extremity to be related to Shingrix.     It was unknown if the company considered the tingling of extremity to be related to Shingrix.   Additional Information: GSK Receipt Date: 22-MAR-2023 The patient reported that he/she received a dose of Shingrix about 1 month ago. The patient reported that he was experiencing tingling on the same side of his body that he received the vaccine in (right). The reporter describes the tingling as ants crawling on him which starts at the top of his shoulder and down his arm. The tingling comes and goes. The patient reports that also about 1 month ago he received an IV solution for a Stress Test. The patient believes that the Shingrix vaccine he received last month was his second dose. He believes he received the first dose in 2019  The reporter consented to follow up. The reporter gave consent to follow up with HCP (healthcare profesional) (pharmacy). 1st dose taken on 2019 and 2nd dose on 2023 which lead to Drug dose administration interval too long.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Breast pain, Pyrexia
Clinical narrative: fever; breast pain; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of fever in a 28-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number H242K, expiry date 09-JUN-2025) for prophylaxis.   On 16-MAR-2023, the patient received Boostrix (intramuscular, unknown arm) .5 ml. On 16-MAR-2023, less than a day after receiving Boostrix, the patient experienced fever (Verbatim: fever) and breast pain (Verbatim: breast pain). The outcome of the fever and breast pain were not resolved.   It was unknown if the reporter considered the fever and breast pain to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the fever and breast pain to be related to Boostrix and Boostrix 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: 23-MAR-2023 A pharmacist reported that a patient received Boostrix one week ago and that day she developed a fever and breast pain.  The reporter consented to follow up.  The Vaccine Administration Facility was the same as Primary Reporter.
Sex: U
Vaccine: DTAPIPV
Symptoms: Extra dose administered
Clinical narrative: received an extra dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in an unspecified number of patients who received DTPa-IPV (Kinrix) for prophylaxis.   On an unknown date, the patient received Kinrix. On an unknown date, an unknown time after receiving Kinrix, the patient experienced extra dose administered (Verbatim: received an extra dose). The outcome of the extra dose administered was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 28-Mar-2023 The reporter reported that anonymous report made about numerous patients getting an extra dose of kinrix. The reporter denied to follow-up. The patients received an extra dose of Kinrix, which led to extra dose administered.
Age: 0.17
Sex: F
Vaccine: RV1
Symptoms: Incorrect route of product administration
Clinical narrative: Dose administered IM in patient's left thigh; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate route of vaccination in a 2-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number T399L, expiry date 17-FEB-2025) for prophylaxis.   On 28-MAR-2023, the patient received the 1st dose of Rotarix lyophilized formulation (intramuscular, left thigh). On 28-MAR-2023, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced inappropriate route of vaccination (Verbatim: Dose administered IM in patient's left thigh). 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: 28-Mar-2023 The nurse reported that another staff member inadvertently administered a dose of Rotarix intramuscularly instead of orally to a patient. The vaccine administration facility was the same as primary reporter. The reporter gave permission for follow-up. The patient received a dose of Rotarix intramuscularly in left thigh instead of orally, which led to inappropriate route of vaccination.
Age: 65.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 20-oct-2022, 2nd dose 29-nov-2022, 3rd 23-feb-2023; 1st dose 20-oct-2022, 2nd dose 29-nov-2022; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 65-year-old male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 23-FEB-2023, the patient received the 3rd dose of Twinrix. On 29-NOV-2022, the patient received the 2nd dose of Twinrix. On 29-NOV-2022, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose 20-oct-2022, 2nd dose 29-nov-2022). On 23-FEB-2023, the patient experienced drug dose administration interval too short (Verbatim: 1st dose 20-oct-2022, 2nd dose 29-nov-2022, 3rd 23-feb-2023). The outcome of the drug dose administration interval too long and drug dose administration interval too short were 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: 28-Mar-2023 A pharmacist reported that the vaccines were given at the reporting clinic. The reporter did not had the lot or expiry date at the time of report. The late 2nd dose was discovered during the escalated call to another agent. No symptom were reported. The reporter consented to follow-up via email. The patient received 2nd dose of Twinrix later than the recommended interval and 3rd dose of Twinrix earlier than the recommended interval, which led to lengthening of vaccine schedule and shortening of vaccine schedule. The facility type was captured as clinic as in reported information it was reported that the patient got the vaccines at the reporting clinic and for the same query was raised.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose on 26Aug2019, 2nd not received; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 55-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 26th August 2019).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: 1st dose on 26Aug2019, 2nd not received). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date:28-Mar-2023 The pharmacist stated that the patient has not yet received second dose, though she did receive a prescription for it from this patient's provider.   At the time of reporting, the reporter did not had the lot number or expiration date of the first dose available. The reporter gave permission for follow-up. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose on 21Sep2020, 2nd dose 2 days ago; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 21st September 2020).   On 28-MAR-2023, the patient received the 2nd dose of Shingrix (intramuscular). On 28-MAR-2023, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose on 21Sep2020, 2nd dose 2 days ago). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 28-Mar-2023 and 30-Mar-2023 The patient received 2 days ago from the reporting date. The reporter consented to follow-up. The patient received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule. The case was linked with case US2023046729, reported by same reporter.; Sender's Comments:  US-GSK-US2023046729:Same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 21Sep2020, 2nd not yet; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose on 21st September 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 incomplete course of vaccination (Verbatim: 1st dose 21Sep2020, 2nd not yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 28-Mar-2023 The reporter consented to follow-up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The case was linked with case US2023046728, reported by same reporter.; Sender's Comments:  US-GSK-US2023046728:Same reporter
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Pruritus, Skin discolouration, Vaccination failure
Clinical narrative: 6 months after 2nd shot, got shingles6 months after 2nd shot, got shingles/ suspected vaccination failure; Shingles on arm - 1st outbreak; Dark marks; Burning; Itching; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Additional patient notes included No prior history of shingles..   On 24-FEB-2022, the patient received the 2nd dose of Shingrix. On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 6 months after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced vaccination failure (Verbatim: 6 months after 2nd shot, got shingles6 months after 2nd shot, got shingles/ suspected vaccination failure) (serious criteria GSK medically significant), herpes zoster (Verbatim: Shingles on arm - 1st outbreak), skin discoloration (Verbatim: Dark marks), burning sensation (Verbatim: Burning) and pruritus (Verbatim: Itching). The outcome of the vaccination failure was unknown and the outcome of the herpes zoster, burning sensation and pruritus were resolved and the outcome of the skin discoloration was not resolved.   The reporter considered the vaccination failure, herpes zoster, skin discoloration, burning sensation and pruritus to be related to Shingrix and Shingrix.     The company considered the vaccination failure, herpes zoster, skin discoloration, burning sensation and pruritus to be related to Shingrix and Shingrix.   Linked case(s) involving the same patient:  US2023AMR047695   Additional Information: GSK receipt date: 29-MAR-2023 The reporter was the patient's husband.  She had both Shingrix shot 1 and shot 2.  The reporter did not have the exact date of Shingrix shot 1 but received toward the end of 2021. The reporter provided the pharmacy name and phone number where the shots were administered as the pharmacy would have the date of administration on file as well as the lot number, site, and route of administration.  He reported that after about 6 months (after the second shot) she got the shingles on her arm.  It sort of went away except the dark marks and all but most of the burning and itching went away.  The reporter confirmed that this was his wife's first shingles outbreak. No prior history of shingles previous to this. The wife was in the room and did not object to her husband giving her MD contact information. The reporter consented to follow up. This case was considered as suspected vaccination failure since details regarding laboratory confirmation of shingles was not reported.; Sender's Comments:  US-GSK-US2023AMR047695:same reporter
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: SAME SYMPTOMS; This spontaneous report received from a consumer concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced same symptoms. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of same symptoms was not reported. This report was non-serious. This case, from the same reporter is linked to 20230406811.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold
Clinical narrative: has chills and she is cold all of the time and she has never had that before.; This spontaneous case was reported by a patient and describes the occurrence of FEELING COLD (has chills and she is cold all of the time and she has never had that before.) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 065F21A and 011J20A) for COVID-19 vaccination.     No medical history information was provided.  Concomitant products included ESTROGENS CONJUGATED (PREMARIN) for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2022, the patient experienced FEELING COLD (has chills and she is cold all of the time and she has never had that before.). At the time of the report, FEELING COLD (has chills and she is cold all of the time and she has never had that before.) had not resolved.      The patient stated that she had been getting chills for about a year at the time of report and was thinking it was just because of she was getting old but wondered if it could be connected. Also reported she doesn't know whether to take more boosters or not because she suffers with that chill. She just (at the time of report) had knee surgery she was moving slowly.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction, Vaccination site pain
Clinical narrative: Patient got a minor reaction (did not specify); Injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (Patient got a minor reaction (did not specify)) and VACCINATION SITE PAIN (Injection site pain) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Patient got a minor reaction (did not specify)) and VACCINATION SITE PAIN (Injection site pain). At the time of the report, IMMUNISATION REACTION (Patient got a minor reaction (did not specify)) and VACCINATION SITE PAIN (Injection site pain) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. The DOB of the patient was reported as 1970 (partial date) No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Nightmare, Palpitations
Clinical narrative: Racing heart; Sleeplessness; Nightmares; Fatigue; This spontaneous case was reported by a non-health professional and describes the occurrence of PALPITATIONS (Racing heart), INSOMNIA (Sleeplessness), NIGHTMARE (Nightmares) and FATIGUE (Fatigue) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PALPITATIONS (Racing heart), INSOMNIA (Sleeplessness), NIGHTMARE (Nightmares) and FATIGUE (Fatigue). At the time of the report, PALPITATIONS (Racing heart), INSOMNIA (Sleeplessness), NIGHTMARE (Nightmares) and FATIGUE (Fatigue) had resolved.     Year of birth at vaccination was reported as 1981.  Concomitant medications were not reported.  Patient received moderna booster in late 2021/early 2022 and experienced side effects. It was reported that patient got knocked out. Symptoms were improved within 12 hours and were subsided entirely within 48 hours. Patient did not had Covid.  Treatment information was not reported.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pyrexia, Vaccination failure, Wrong product administered
Clinical narrative: Fever; wrong vaccine administered; Lack of effect; Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION FAILURE (Lack of effect), PYREXIA (Fever), COVID-19 (Covid-19) and WRONG PRODUCT ADMINISTERED (wrong vaccine administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown whether patient had any allergies to  vaccines, medication and food.  Previously administered products included for Product used for unknown indication: pfizer vaccine (side effects experienced with their Pfizer vaccine doses.). Past adverse reactions to the above products included Vaccination adverse reaction with pfizer vaccine.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2022, the patient experienced VACCINATION FAILURE (Lack of effect) and COVID-19 (Covid-19). On an unknown date, the patient experienced PYREXIA (Fever) and WRONG PRODUCT ADMINISTERED (wrong vaccine administered). At the time of the report, VACCINATION FAILURE (Lack of effect), COVID-19 (Covid-19) and WRONG PRODUCT ADMINISTERED (wrong vaccine administered) outcome was unknown and PYREXIA (Fever) had resolved.            The year of birth of patient reported as 1974.  Concomitant products were not reported.It was reported that patient had received one Moderna booster and described a side effect of fever with the Moderna booster that "lasted slightly longer" than any side effects experienced with the Pfizer vaccine doses. The fever experienced following their Moderna booster was described as mild and subsided within half a day. Patient also had been infected with COVID (September 2022). Experience of symptoms with COVID was also described as mild, limited mostly to fever and cough. It was unknown if the event cause the patient to seek medical care.  Treatment medications were not reported.  Company comment: This spontaneous case concerns a male patient of unknown age with no medical history reported, who experienced the unexpected non serious event of COVID-19 in the context of booster dose of mRNA-1273 vaccination. Additionally, Vaccination failure was also reported. Latency cannot be assessed since exact vaccination date and event onset date were not disclosed.  Patient experienced fever after booster vaccination which was mild subsided in half a day and also had mild cough.  No further information on risk factors, investigations, treatment of the events, details of previous doses was available in the report. The outcome of the event covid-19 was unknown. Current pandemic situation of COVID 19 may remain as confounder to the event Covid -19. The benefit-risk relationship mRNA-1273 vaccination is not affected by this report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Covid arm/ pain/ intense itchiness/ stiffnes; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE REACTION (Covid arm/ pain/ intense itchiness/ stiffnes) in a 6-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Patient had no known allergies to vaccines, medications, food and other products.     On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION SITE REACTION (Covid arm/ pain/ intense itchiness/ stiffnes). At the time of the report, VACCINATION SITE REACTION (Covid arm/ pain/ intense itchiness/ stiffnes) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient age was reported as mid 50s.   No concomitant medication was provided.  It was reported that in 2021, patient had experienced covid arm after received the moderna vaccine dose and symptoms reported included pain and intense itchiness, stiffness that lasted for more than 2 weeks before subsided.   It was unknown that the event caused the patient to seek medical care.   Treatment medication was not provided by the reporter.
Age: 0.5
Sex: M
Vaccine: COVID19
Symptoms: Ear infection
Clinical narrative: Bilateral otitis; This spontaneous case was reported by a health care professional and describes the occurrence of EAR INFECTION (Bilateral otitis) in a 9-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AS1412B and AS1412B) for COVID-19 prophylaxis.     No Medical History information was reported.   On 07-Nov-2022 at 8:20 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 10-Dec-2022 at 3:37 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 01-Feb-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EAR INFECTION (Bilateral otitis). On 10-Feb-2023, EAR INFECTION (Bilateral otitis) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  The patient had never been diagnosed with/tested positive for COVID-19.   This case was linked to MOD-2023-713290 (Patient Link).
Age: 1.42
Sex: M
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: Influenza A; This spontaneous case was reported by an other health care professional and describes the occurrence of INFLUENZA (Influenza A) in a 17-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR9237B and AR9237B) for COVID-19 prophylaxis.     Patient had no known allergies.  Patient had no chronic or long-standing health condition. The patient never been diagnosed with/ tested positive for COVID-19.  Concomitant products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) and HEPATITIS A VACCINE INACT (VAQTA) for an unknown indication.   On 06-Sep-2022 at 3:22 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 04-Oct-2022 at 3:23 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 06-Jan-2023, the patient experienced INFLUENZA (Influenza A). At the time of the report, INFLUENZA (Influenza A) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment drug was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-713298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-713298:Bivalent dose case
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: cramp; This spontaneous case was reported by an other health care professional and describes the occurrence of MUSCLE SPASMS (cramp) in a 2-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. AR237B and AR237B) for COVID-19 prophylaxis.     Patient had never been tested positive or diagnosed with COVID-19. The patient had no chronic or long standing health conditions.    On 02-Aug-2022 at 11:12 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter. On 31-Aug-2022 at 8:55 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 13-Jan-2023, the patient experienced MUSCLE SPASMS (cramp). At the time of the report, MUSCLE SPASMS (cramp) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2023-713292 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: the patient had a serious reaction to her Moderna vaccination (second shot); This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (the patient had a serious reaction to her Moderna vaccination (second shot)) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 immunisation.     No Medical History information was reported.    On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (the patient had a serious reaction to her Moderna vaccination (second shot)) (seriousness criterion medically significant). At the time of the report, IMMUNISATION REACTION (the patient had a serious reaction to her Moderna vaccination (second shot)) outcome was unknown.            Concomitant medication of the patient was not reported.  No treatment medications were reported by the reporter.  Company comment: This is a spontaneous case regarding a female patient of an unknown age, with no reported medical history, who experienced unexpected and medically significant event of immunisation reaction after receiving the second dose of mRNA-1273 vaccine. Vaccination date and onset date of the event were not provided, latency cannot be assessed. It was reported that the patient had a serious reaction; no further details regarding clinical course, diagnostic tests, or treatment performed were disclosed. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.   Reporter did not allow further contact
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Patient received first dose on 19Jan2021 and second dose on 27Feb2021; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 19Jan2021 and second dose on 27Feb2021) and NO ADVERSE EVENT (No adverse event) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A, 014M20A, 058H21A and 051B22A) for COVID-19 prophylaxis.     Patient didn't had any drug allergy.  Concurrent medical conditions included Diabetes, Thyroid disorder and Blood pressure abnormal. Concomitant products included LISINOPRIL, LEVOTHYROXINE SODIUM (SYNTHROID), COLESEVELAM HYDROCHLORIDE (WELCHOL), DULAGLUTIDE (TRULICITY), LEVOFLOXACIN (LEVOXL), METFORMIN, ATORVASTATIN, ALLOPURINOL and FENOFIBRATE for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 19Jan2021 and second dose on 27Feb2021). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received first dose on 19Jan2021 and second dose on 27Feb2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            It was reported that the patient took Paxlovid from 20Mar2023 to 25Mar2023 for treatment of COVID-19.  Patient had tested negative for COVID-19 test on 29Mar2023. However, on 31Mar2023, patient started to experience symptoms again and on 1Apr2023, patient tested positive for COVID-19. For COVID-19 the outcome was provided as not recovered and patient was neither hospitalized nor received any treatment for it.   Treatment medication information was not provided.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; Date the vial was initially stored in the refrigerator was 23-Dec-2022.; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 23-Dec-2022.) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 23-Dec-2022.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 23-Dec-2022.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 23-Dec-2022.).    No concomitant medications were reported.  It was Unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. It was reported that 42 doses of 6M-5Y vaccine were administered after 30 day use by date to patients. Vial size was reported as 0.4 ml per vial. The vial was initially stored in the refrigerator on 23-Dec-2022. The vaccine was administered on 26-Jan-2023, 27-Jan-2023, 30-Jan-2023, 31-Jan-2023, 02-Feb-2023,06-Feb-2023, 08-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023, 21-Feb-2023. The vial did not undergo any temperature excursions.  No treatment details were reported. This case was reported for patient 11 out of 42 Patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD; 42 Dose administered after 30-day use by date; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (42 Dose administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD). an unknown date, the patient experienced PRODUCT STORAGE ERROR (42 Dose administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD), PRODUCT STORAGE ERROR (42 Dose administered after 30-day use by date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (pediatric nurse practitioner states they gave some pediatric 6m-5y after the BUD) and PRODUCT STORAGE ERROR (42 Dose administered after 30-day use by date).    Concomitant medication details not reported by the reporter. Vial size was reported as 0.4 ml per vial. Vial was initially stored in refrigerator on 23-DEC-2022. Vial did not undergo any temperature excursion. Treatment details was not reported by the reporter. This case contains information about patient 19th out of 42 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Patient 1 (Master Case)