chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Incomplete course of vaccination, Transplant
Clinical narrative: Transplant; received 2 doses of Twinrix in 2010 / 2 doses of 3; This case was reported by a pharmacist via call center representative and described the occurrence of transplant in a male patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in 2010).   On an unknown date, the patient received the 2nd dose of Twinrix, Twinrix Pre-Filled Syringe Device, the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced transplant and incomplete course of vaccination. On an unknown date, the outcome of the transplant and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the transplant to be related to Twinrix and Twinrix Pre-Filled Syringe Device.   This report is made without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported for 2nd dose and was not applicable for 3rd dose. The reporter stated that the patient might have received 2 doses of Twinrix in 2010. He was not sure if the patient received Twinrix or other vaccine (in the chart said the patient a Hepatitis combo vaccine and 2 doses of 3, so pharmacist thought that it was Twinrix). Till the time of reporting, the patient did not receive the 3rd dose of the vaccine, which led to incomplete course of vaccination. The patient received a transplant afterwards (reporter was not sure of which type of transplant). The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Intensive care, Swelling, Urticaria
Clinical narrative: Hives; swelling; A spontaneous report was received from a pharmacist concerning a female patient participating who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the serious event of swelling and hives.   The patient's medical history, as provided by the reporter, included an "extensive history of allergies" and history of taking diphenhydramine prior to influenza vaccination. No relevant concomitant medications were reported.   On 27 Dec 2020, approximately 7 minutes prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 27 Dec 2020, the patient was admitted to the hospital with swelling and hives occurring 7 minutes after the injection. She was admitted to the intensive care unit (ICU) overnight and stayed approximately 24 hours. She did not require intubation. Treatment for the event included an epinephrine drip.  On 30 Dec 2020, the hives and swelling returned. The patient planned to go to the hospital, but she was not sure if she would be admitted.   Action taken with mRNA-1273 in response to the events was not reported.   The events, swelling and hives, were considered not resolved.   The reporter did not provide assessment for the events of swelling and hives.; Reporter's Comments: This case concerns a female patient with an extensive history of allergies, who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), who experienced unexpected events of urticaria and swelling and hives on the same day, approximately 7 minutes after vaccination. The reporter did not provide the causality assessment for the events. Due to the temporal association between the events (urticaria and swelling) and the administration of the vaccine, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Out of specification product use
Clinical narrative: We inadvertently administered the moderna vaccine past the 6 hours to a few clients of ours today; A spontaneous report was received from a nurse concerning two patients who were administered Moderna's COVID-19 vaccine inadvertently past the six hours.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an undisclosed date, prior to the onset of the event, the two patients received their first of the two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. The patients were inadvertently administered the Moderna vaccine past the six hour window; the healthcare providers thought that it was a new vial that had just been opened. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, inadvertently administered the Moderna vaccine past the 6 hours, was resolved.; Reporter's Comments: This report refers to a case of a patients of unknown gender who experienced non-serious event of was administered vaccine inadvertently past the six hours (out of specification product use) for mRNA-1273, (Lot # unknown, expiration date-unknown). There were no reported AEs associated with this case of vaccine inadvertently administered past the six hours.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: did not receive the full 2nd dose of the Moderna Covid-19 Vaccine; some vaccine was leaking out from the syringe; A spontaneous report  was received from a pharmacist concerning a patient (unknown age, unknown gender) who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced some vaccine leaking out of the syringe (vaccine underdose/syringe connection issue) and did not receive the full 2nd dose of the Moderna Covid-19 Vaccine.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On 29 Jan 2021 the pharmacist called to report that, prior to the onset of events, the patient received their second of two planned doses of mRNA-1273 (Batch number: not provided) for prophylaxis of COVID-19 infection.  On 29 Jan 2021 the pharmacist called and stated that a patient may not have received the full second dose of the Moderna COVID-19 vaccine as some vaccine was leaking out from the syringe.  Treatment for the event was unknown.  The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event is not applicable.  The event of some vaccine leaking out of the syringe (vaccine underdose/syringe connection issue) and did not receive the full 2nd dose of the Moderna Covid-19 Vaccine was considered resolved.; Reporter's Comments: This report refers to a case of incorrect dose administered and syringe issue for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of incorrect dose administered and syringe issue.
Sex: U
Vaccine: COVID19
Symptoms: Product administered at inappropriate site
Clinical narrative: Administered the Moderna COVID-19 vaccine below the deltoid  and more anterior towards the front; A spontaneous report was received from a healthcare professional concerning an unknown aged and unknown gender patient who received Moderna's COVID-19 vaccine (mRNA-1273) below the deltoid and more anterior towards the front.  The patient's medical history was not provided.  No relevant concomitant medications were reported.  On an unspecified date, the patient received a dose of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.  The patient was administered the mRNA-1273 below the deltoid and anterior towards the front. No treatment information was provided.   Action taken with the mRNA-1273 was not reported.  The event, product administered at inappropriate site, was considered resolved on an unspecified date.; Reporter's Comments: This report refers to a case of product administered at inappropriate site for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Product administered at inappropriate site, Vaccination site pruritus, Vaccination site rash
Clinical narrative: Developed rash a inch and a half diameter; Also Itchy; Also Itchy and warm; Injection was given in the tricepes area half way between the shoulder and elbow; A spontaneous report was received from a consumer concerning an 80-year-old, female patient who was administered Moderna's COVID-19 mRNA-1273 vaccine in the triceps area half way between the shoulder and elbow, later she developed a rash a inch and a half diameter, also itchy and warm .   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Jan 2021, patient received 1st dose of the Moderna vaccine mRNA-1273 (Lot number: 032L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  The patient was administered mRNA-1273 vaccine in right arm slightly lower than where she should receive it, she states it was given in the triceps area half way between the shoulder and elbow. On 31 Jan 2021, approximately 8 days after vaccine administration, patient developed a rash of an inch and a half diameter, which was also itchy and warm. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not reported.  The event,  "vaccine in the triceps area half way between the shoulder and elbow" was considered resolved on 23 Jan 2021. The outcome of the events vaccine site rash, itchiness, and warmth was considered as unknown.; Reporter's Comments: This case concerns 80-year-old, female patient  experienced non-serious events of  Vaccine administered at inappropriate site (Injection was given in the triceps area half way between the shoulder and elbow) for 1st dose of the Moderna vaccine mRNA-1273 (Lot number: 032L20A).Additionally, eight days later patient experienced  Vaccination site rash, Vaccination site pruritus and Vaccination site warmth. The events of Vaccine administered at inappropriate site and Vaccination site warmth are unexpected, Vaccination site rash is expected, and Vaccination site pruritus is expected for SmPC and Swiss SmPC. The company causality for reported event of Vaccine administered at inappropriate site is not applicable all other events were assessed as possibly related to Moderna vaccine mRNA-1273.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: One of my coworkers gave a Moderna vaccine to someone under the age of 18; A spontaneous report  was received from a healthcare professional concerning a 17-year-old patient, who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (lot number: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, one of the reporter's coworkers gave a Moderna vaccine to someone who was under the age of 18. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The event, "one of my coworkers gave a Moderna vaccine to someone who is under the age of 18", was considered resolved on an unknown date.; Reporter's Comments: This case concerns a 17 year old patient who received their first of two planned doses of mRNA-1273 (lot number: unknown) for prophylaxis of COVID-19 infection. There were no reported adverse events after the vaccine was administered in the case of product administered to patient of inappropriate age.
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year old received vaccine; A spontaneous report was received from a Pharmacist concerning a 16-year-old, male patient with unknown race who was administered Moderna's COVID-19 mRNA-1273 vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, patient received a dose of the Moderna vaccine mRNA-1273 (Lot number: unknown) by injection for prophylaxis of COVID-19 infection.  On unknown date, a minor patient received the mRNA-1273 vaccine at mass vaccination site.   Action taken with mRNA-1273 in response to the event was not reported.   The event, "16 year old received vaccine" was considered as resolved on an unknown date.; Reporter's Comments: This case concerns a 16-year-old male patient who received their first of two planned doses of mRNA-1273 (Lot: unknown), reporting Product administered to patient of inappropriate age.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: not properly injected, they've missed the deltoid; A spontaneous report was received from a physician concerning a 71-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) which was not injected properly and missed the deltoid.  The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.  On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273  (Lot number: unknown) for the prophylaxis of COVID-19 infection.  The physician reported that a patient was not injected properly with the Moderna COVID-19 vaccine, and missed her muscle and the vaccine was injected nowhere near the deltoid. Treatment for the event was not provided.  Action taken with mRNA-1273 in response to the events was not reported.  The event, vaccine was not injected properly and missed the deltoid was considered resolved on an unknown date.; Reporter's Comments: This case concerns a 71-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot: unknown), reporting Incorrect route of product administration.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Needle issue
Clinical narrative: Needle broke; Did not receive the full dose; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced did not receive full dose and needle broke.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection. During vaccine administration, the needle broke, and the patient did not get the full dose. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, did not receive full dose and needle broke, were considered resolved on 22 Jan 2021.; Reporter's Comments: A spontaneous report from a consumer concerning a female patient who experienced non-serious events of did not receive full dose (Incomplete dose administered) and needle broke for administration of mRNA-1273 (Lot number: unknown expiration date-unknown).  There were no reported AEs associated with this case of did not receive full dose and needle broke.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Deafness unilateral, Ear discomfort, Erythema, Hypoaesthesia
Clinical narrative: her arm was red, swollen, and growing; her arm was red, swollen, and growing; She had numbness in parts of the ear and is now able to feel parts of the ear, but she is not sure if the numbness will go away; Caller mentioned that she can feel her ear "closing up" and by Saturday-Sunday had lost hearing on the right ear; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A 68-year-old female patient received her 1st bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Batch/lot number: EK9231) single dose on 22Jan2021 10:45 AM at right arm for COVID-19 immunization. Medical history included COVID on 05Nov2020 but was mild only and she was not hospitalized; No medications aside from over-the-counter drugs. The patient was given a Z-pack and vitamin C and immune stuff like Zinc. Concomitant drugs included high blood pressure medication. Around 6:00 PM on 22Jan2021, the patient can feel her ear "closing up" and by Saturday-Sunday had lost hearing on the right ear - the same side of her arm she received the vaccine. The patient stated it was better on 25Jan2021 but still not 100 percent. The patient tried calling the emergency room and has read up and no one can give her any answers. She made an appointment this morning with her doctor to see what was going on, states not being able to hear messes with her equilibrium. The patient was supposed to have another dose on 12Feb2021 and wanted to know if she should. The patient currently still had partial hearing loss and was prescribed a Prednisone that she took for 5 days. Her arm did not hurt Friday through Sunday, however, on Monday, her arm was red, swollen, and growing. She was able to get partial hearing back after taking Prednisone. She had numbness in parts of the ear and was now able to feel parts of the ear, but she was not sure if the numbness will go away. The outcome of hearing loss was resolving, of other events was unknown.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: her arm was red, swollen, and growing; her arm was red, swollen, and growing; She had numbness in parts of the ear and is now able to feel parts of the ear, but she is not sure if the numbness will go away; Caller mentioned that she can feel her ear "closing up" and by Saturday-Sunday had lost hearing on the right ear; This is a spontaneous report from a contactable consumer via Pfizer sponsored program. A 68-year-old female patient received her 1st bnt162b2 (Pfizer-Biontech Covid-19 Vaccine; Batch/lot number: EK9231) single dose on 22Jan2021 10:45 AM at right arm for COVID-19 immunization. Medical history included COVID on 05Nov2020 but was mild only and she was not hospitalized; No medications aside from over-the-counter drugs. The patient was given a Z-pack and vitamin C and immune stuff like Zinc. Concomitant drugs included high blood pressure medication. Around 6:00 PM on 22Jan2021, the patient can feel her ear "closing up" and by Saturday-Sunday had lost hearing on the right ear - the same side of her arm she received the vaccine. The patient stated it was better on 25Jan2021 but still not 100 percent. The patient tried calling the emergency room and has read up and no one can give her any answers. She made an appointment this morning with her doctor to see what was going on, states not being able to hear messes with her equilibrium. The patient was supposed to have another dose on 12Feb2021 and wanted to know if she should. The patient currently still had partial hearing loss and was prescribed a Prednisone that she took for 5 days. Her arm did not hurt Friday through Sunday, however, on Monday, her arm was red, swollen, and growing. She was able to get partial hearing back after taking Prednisone. She had numbness in parts of the ear and was now able to feel parts of the ear, but she was not sure if the numbness will go away. The outcome of hearing loss was resolving, of other events was unknown.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Delirium, Discomfort, Head discomfort, Headache
Clinical narrative: Delirium; headache; body chills; nausea; strong pressure felt in head and neck; strong pressure felt in head and neck; blurred vision; This is a spontaneous report from a contactable consumer (patient).  A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9261, expiry date not reported) via an unspecified route of administration at left arm, on 22Jan2021 10:45, single dose, for COVID-19 immunization.  Medical history included neoplasm malignant and hypersensitivity. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccine in the last four weeks. It was unknown if the patient has COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medication included alprazolam (XANAX) and doxycycline hyclate. On 22Jan2021 14:00, the patient experienced delirium, headache, body chills, nausea, strong pressure felt in head and neck, and blurred vision. Outcome of the events was not recovered.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vision blurred
Clinical narrative: Delirium; headache; body chills; nausea; strong pressure felt in head and neck; strong pressure felt in head and neck; blurred vision; This is a spontaneous report from a contactable consumer (patient).  A 32-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EL9261, expiry date not reported) via an unspecified route of administration at left arm, on 22Jan2021 10:45, single dose, for COVID-19 immunization.  Medical history included neoplasm malignant and hypersensitivity. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccine in the last four weeks. It was unknown if the patient has COVID prior vaccination. The patient was not tested for COVID post vaccination. Concomitant medication included alprazolam (XANAX) and doxycycline hyclate. On 22Jan2021 14:00, the patient experienced delirium, headache, body chills, nausea, strong pressure felt in head and neck, and blurred vision. Outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Conversion disorder, Fatigue, Hallucination, Lethargy, Mental status changes
Clinical narrative: Hallucinations; extremely tired/extremely lethargic; extremely tired/extremely lethargic; she wasn't making any sense; UTI; This is a spontaneous report from a contactable consumer.  A 88-years-old female patient (mother) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: unknown), via an unspecified route of administration on 23Jan2021 at single dose for COVID-19 immunization. Medical history included dementia. The patient's concomitant medications were not reported. Reporter was asking if Hallucinations are a side effect of the vaccine. Her mother (patient) got the first dose of the covid vaccine on 23Jan2021. She reported that after getting the vaccine her mother was initially extremely tired but she was still able to carry on regular conversation until this morning when she wasn't making any sense. Reporter stated that this may be due to a possible UTI but she just wanted to see if older people with dementia were having hallucinations after getting the vaccine. It was reported that patient was extremely lethargic and having hallucinations. Reporter was wondering if this could be a reaction to the vaccine. All event from Jan2021. The outcome of the events was unknown.   Information on batch number has been requested.; Sender's Comments: Based on a compatible temporal relationship, contributory role of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) to event hallucinations cannot be completely excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Hypothermia, Peripheral coldness
Clinical narrative: hypothermia; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age (reported as 48, unknown unit) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration on 15Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced hypothermia after receiving the 1st dose of the COVD-19 vaccine last 15Jan2021. She wanted to check if there are reported cases for hypothermia, coldness of hands and feet and recorded body temperature was 95.7 F; all on an unknown date in Jan2021 and unknown outcome. The patient was advised that there was no information available about hypothermia after getting the 1st dose.  Information on Lot/Batch number has been requested.; Sender's Comments: A possible contributory effect of suspect BNT162B2 on reported hypothermia cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate decreased, Hypotension, Loss of consciousness, Vision blurred
Clinical narrative: felt herself losing consciousness; Low blood pressure following event (50/20); My vision went blurry first; This is a spontaneous report from a contactable consumer (patient). A 24-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 25Jan2021 at 09:30 at a single dose in the workplace clinic for COVID-19 immunization. Medical history included asthma and history of vasovagal syncope following vaccinations; this adverse reaction to the vaccination directly aligns with other episodes that have occurred to her following vaccinations/interactions with needles (ie. blood draws). The patient had no COVID prior to vaccination. The patient is not pregnant. Concomitant medication included levonorgestrel (MIRENA). On 25Jan2021 at 09:30 (after getting the vaccine), the patient felt herself losing consciousness, her vision went blurry first and she was able to brace herself by lying down against a wall, and low blood pressure following event (50/20). Blood pressure and pulse rose over the next 25 minutes. 15 minutes more of observation was completed. The patient did not receive treatments for the events. The patient was not tested for COVID post vaccination. The patient recovered from the events.  Information on the Batch/Lot number has been requested.
Age: 75.0
Sex: U
Vaccine: COVID19
Symptoms: Atrial fibrillation, Cardiac monitoring abnormal, Condition aggravated, Palpitations
Clinical narrative: atrial fibrillation; heart palpitations; This is a spontaneous report from a contactable consumer (patient). A 75-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EL3248) via an unspecified route of administration on 21Jan2021 15:00 at single dose for COVID-19 immunization. Medical history included palpitations years ago. The patient's concomitant medications were not reported. Patient received the vaccine at 15:00 on 21Jan2021 and around 20:00, patient started getting heart palpitations. Years ago patient did have palpitations at times but had not had them like this that did not go away. Patient went to ER and the heart monitor showed patient had atrial fibrillation. Patient was sent home to follow up with primary care physician. Patient would be seeing her this coming Thursday. This was the fourth day after patient shot and patient was still bothered by them. No treatment received. Patient asked if it was the vaccine that started these palpitations up. No covid prior vaccination. No covid tested post vaccination. The patient underwent lab tests and procedures which included heart monitor showed atrial fibrillation in Jan2021. The outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Pericardial effusion, Viral pericarditis
Clinical narrative: fluid on her heart caused by a virus; fluid on her heart caused by a virus; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unspecified route of administration on (lot number and expiry date unknown) at single dose for Covid-19 immunization. Medical history included low fever from 01Jan2021 (negative for covid on 01Jan2021). The patient's concomitant medications were not reported. On 14Jan2021, the patient was hospitalized for fluid on her heart caused by a virus on unspecified date. The patient was scheduled to take her second dose of the vaccine on Saturday (unspecified date). The patient would like to know if she would be able to get her second dose of the Pfizer Covid vaccine after the side effects she experienced post-vaccination on the first dose. Her family doctor has told her to wait 90 days. She was also scheduled to visit her cardiologist tomorrow. The outcome of the events fluid on her heart caused by a virus was unknown.  Follow-up activities are possible, information on the batch number has been requested.
Sex: M
Vaccine: FLUX
Symptoms: Flatulence, Gait inability, Mobility decreased
Clinical narrative: ill with gas; can't walk; can't move arms; Initial information received on 14-Dec-2020 regarding an unsolicited valid serious case received from a consumer or non-healthcare professional via media.  This case involves a 69-years-old male patient who experienced ill with gas (flatulence), can't walk (gait inability) and can't move arms (limb immobilisation), while he received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) lot number not reported via an unknown route at an unknown administration site for professional.  On an unknown date, the patient was ill with gas (flatulence), can't walk (gait inability) and can't move arms (limb immobilisation) (unknown latency) following the administration of INFLUENZA VACCINE. The patient was hospitalized these events for duration of three months, rest home over a month.  It is unknown if the patient experienced any additional symptoms/events.  Medication details and reason for taking the medicine was unknown.  Patient's wife took the low dose while husband got the double dose of the INFLUENZA VACCINE.  There were no lab data/results available.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for gait inability and limb immobilisation.  At the time of this report, outcome of the flatulence was not recovered (going on since 5-months).  Batch number has been requested for suspect product for this case.; Sender's Comments: This poorly documented media case concerns a 69-years-old male who suffered from flatulence, gait inability and limb immobilisation after vaccination with INFLUENZA VACCINE (produced by unknown manufacturer). The time to onset was unknown. However, patient's medical condition at the time of vaccination, lab tests ruling out alternate etiologies were not reported. Based upon the reported information, the role of the vaccine cannot be assessed.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; incorrect product storage; This spontaneous report was received from an unspecified report and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 18-DEC-2020, the patient was vaccinated with improperly stored doses of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) lot # T007790 with expiration date 03-DEC-2021, 0.5 milliliter for prophylaxis. No other adverse event (AE) was reported. The vaccine experimented Temperature of 31.2 F for 30 minutes. No Previous temperature excursión. Digital data logger was involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T007790; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: headache; soreness; This case was reported by a consumer and described the occurrence of headache in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced headache and pain. On an unknown date, the outcome of the headache and pain were unknown.   The reporter considered the headache and pain to be related to Shingrix.  Additional details were provide as follow: The case was reported by patient. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient had headaches and soreness from Shinglrex vaccine also asked could the patient take Advil or Tylenol.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Headache, Incorrect route of product administration, Inflammation
Clinical narrative: Inflammatory reaction; Pain in her shoulder; Tingling in fingers; Diarrhea; Headache; Nausea; Inflammatory reaction with swelling, redness and heat; Inflammatory reaction with swelling, redness and heat; Induration to her arm; Sub q injection; A spontaneous report was received from a physician assistant concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sub q injection, nausea, headache, diarrhea, significant swelling, redness and induration in her arm, inflammatory reaction, pain in her shoulder and tingling in her fingers.   The patient's medical history was not provided. No concomitant product use was reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) for prophylaxis of COVID-19 infection.   On 13 Jan 2021, the patient was given the injection in the posterior lateral arm and it appeared to have been given subcutaneously.  On 14 Jan 2021, the patient was nauseated, had a headache, diarrhea, and significant swelling with redness and induration to her arm. The skin reaction resolved on day 8, however it returned on day 9 at which point she visited her family practice.   On 22 Jan 2021, she had an inflammatory reaction with swelling, redness and heat for which she was given diphenhydramine and loratadine. The patient also complained of pain in her shoulder and tingling in her fingers.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, sub q injection, was considered resolved on 13 Jan 2021. The outcome of the events, nausea, headache, diarrhea, significant swelling, redness and induration in her arm, inflammatory reaction, pain in her shoulder and tingling in her fingers, was unknown.; Reporter's Comments: This case concerns a female patient of unknown age. The medical history is not provided. The patient experienced non-serious unexpected events of Incorrect route of product administration, Paraesthesia, Diarrhea, Inflammation, and non-serious expected events of Injection site induration, Injection site swelling, Injection site erythema, Arthralgia, Headache and Nausea. The events of Injection site induration, Injection site swelling, Injection site erythema, Diarrhea, Headache and Nausea occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot #041L20A).  The events of Inflammation, Paresthesia and Arthralgia approximately nine days after receiving their first of two planned doses of mRNA-1273 (Lot #041L20A). Treatment included diphenhydramine and loratadine. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Nausea, Paraesthesia
Clinical narrative: Inflammatory reaction; Pain in her shoulder; Tingling in fingers; Diarrhea; Headache; Nausea; Inflammatory reaction with swelling, redness and heat; Inflammatory reaction with swelling, redness and heat; Induration to her arm; Sub q injection; A spontaneous report was received from a physician assistant concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sub q injection, nausea, headache, diarrhea, significant swelling, redness and induration in her arm, inflammatory reaction, pain in her shoulder and tingling in her fingers.   The patient's medical history was not provided. No concomitant product use was reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) for prophylaxis of COVID-19 infection.   On 13 Jan 2021, the patient was given the injection in the posterior lateral arm and it appeared to have been given subcutaneously.  On 14 Jan 2021, the patient was nauseated, had a headache, diarrhea, and significant swelling with redness and induration to her arm. The skin reaction resolved on day 8, however it returned on day 9 at which point she visited her family practice.   On 22 Jan 2021, she had an inflammatory reaction with swelling, redness and heat for which she was given diphenhydramine and loratadine. The patient also complained of pain in her shoulder and tingling in her fingers.   Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the event, sub q injection, was considered resolved on 13 Jan 2021. The outcome of the events, nausea, headache, diarrhea, significant swelling, redness and induration in her arm, inflammatory reaction, pain in her shoulder and tingling in her fingers, was unknown.; Reporter's Comments: This case concerns a female patient of unknown age. The medical history is not provided. The patient experienced non-serious unexpected events of Incorrect route of product administration, Paraesthesia, Diarrhea, Inflammation, and non-serious expected events of Injection site induration, Injection site swelling, Injection site erythema, Arthralgia, Headache and Nausea. The events of Injection site induration, Injection site swelling, Injection site erythema, Diarrhea, Headache and Nausea occurred approximately one day after receiving their first of two planned doses of mRNA-1273 (Lot #041L20A).  The events of Inflammation, Paresthesia and Arthralgia approximately nine days after receiving their first of two planned doses of mRNA-1273 (Lot #041L20A). Treatment included diphenhydramine and loratadine. Based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: syringe is leaking out some of the content in the syringe; did not get all that he suppose to get; A spontaneous report  was received from a reporter concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced syringe leaking contents while administration and did not get all that he was supposed to.   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 28 Jan 2021, the patient received their first of two planned doses of mRNA-1273(Lot number: 010M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 28 Jan 2021, while receiving the vaccine the patient experienced syringe leaking contents and did not get all that he was supposed to. Patient was referred to his health care professional.  Action taken with mRNA-1273 in response to the events was not reported  The events syringe leaking contents while administration and did not get all that he was supposed to, was considered resolved on 28 Jan 2021.; Reporter's Comments: This report refers to a case of Incorrect dose administered and syringe issue for mRNA-1273, lot # 010M20A.  There were no reported AEs associated with this case of Incorrect dose administered and syringe issue.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: liquid started dripping into patient's arm; A spontaneous report was received from a consumer concerning a 42-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced "liquid started dripping into patient's arm".  The patient's medical history, as provided by the reporter included migraine, weight loss and cholesterol. No concomitant medications were reported.  On 01 Feb 2021, the patient received her first dose of mRNA-1273 (Lot number 012M204) for prophylaxis of COVID-19 infection.   The patient stated that while she was receiving her dose, the syringe broke while the nurse was pushing the needle into her arm.  The liquid started dripping into her arm and made a puddle on the table.  The nurse first told her that she administered half of the dose.  The nurse called Moderna to ask if what occurred was fine, and she was told to send the patient home. Treatments of this event are unknown.  Action taken with mRNA-1273 in response to the event was not reported.  The event "liquid started dripping into patient's arm" considered as resolved on 01 Feb 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered for mRNA-1273.  There were no reported adverse events associated with this case.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: patient is 17 and got vaccinated; A spontaneous report was received from a consumer concerning a 17-year old, male patient who received Moderna's COVID-19 vaccine (mRNA-1273).    The patient's medical history was not provided.  Concomitant product use was not provided by the reporter.    On an unknown date, the patient received mRNA-1273 (Lot number: unknown) intramuscularly for prophylaxis of COVID-19 infection.    On an unknown date, the patient, who was 17-years old, was vaccinated.   Action taken with mRNA-1273 in response to the event was not reported.  The event "patient is 17 and was vaccinated" was considered recovered / resolved on an unknown date.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273, lot # unknown.  There were no reported AEs associated with this case of product administered to patient of inappropriate age.
Sex: U
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine is mistakenly administered to a 16yo patient; A spontaneous report  was received from a healthcare professional concerning a 16 year old unknown gender patient who received Moderna's COVID-19 vaccine (mRNA-1273) mistakenly at 16 year old.  The patient's medical history was not provided.  No relevant concomitant medication was reported.  On an unspecified date, the patient was administered a dose of mRNA-1273 (lot number unknown) for prophylaxis of COVID-19 infection.  The patient was 16 years old at the time of administration of the vaccine.  No treatment information was provided.  Action taken with the mRNA-1273 was not reported.  The event, "vaccine is mistakenly administered to a 16yo patient", was considered resolved on an unspecified date.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age for mRNA-1273.  There were no reported adverse events associated with this case.
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 17 year old received vaccine; A spontaneous report was received from a consumer concerning a 17-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 27 Jan 2021, the reporter stated that the vaccine provider refused to administer the second dose since the patient was 17 years old. No treatment information was provided.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.   The outcome of the event, 17-year-old received vaccine, was considered resolved on 27 Jan 2021.; Reporter's Comments: This report refers to a case of product administered to patient of inappropriate age (17 year old female received vaccine) for mRNA-1273, lot # unknown. There were no reported AEs associated with this case of product administered to patient of inappropriate age. The reported event is unlisted and company causality was assessed s not applicable.
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Fatigue, Headache, Pain
Clinical narrative: Body ache; Headache; Fatigue; Two doses; A spontaneous report  was received from a consumer concerning a male patient of unknown age, unknown race and ethnicity, who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced body ache, headache, fatigue and administered two doses of vaccine.  The patient's medical history was not provided. No concomitant medications were reported.  On 27 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (batch number: 09L20A), for prophylaxis of COVID-19 infection.  On the same day, the patient was administered two doses of COVID-19 vaccine.  On 28 Jan 2021, the patient experienced body aches, headache and fatigue after received the COVID-19 vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, body aches, headache and fatigue was not reported and that of extra dose administered was considered as recovered on 27 Jan 2021.; Reporter's Comments: This case concerns a male patient, who experienced an event of extra dose administered and  non-serious expected events of Pain (body ache) , headache, fatigue . There were no AEs associated with event of extra dose administered (two  doses on the same day).The events of Pain (body ache), headache, fatigue occurred 2 days  after two doses of mRNA-1273, lot # 025L20A administered on the same day.  Based on the current available information and temporal association between the use of the product and onset of the events ,  a causal relationship cannot be excluded.