chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Cardiovascular disorder, Herpes zoster, Meningitis, Pneumonia
Clinical narrative: meningitis; pneumonia; cardiovascular event; congestive heart failure; postherpetic neuralgia; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about 27-JUL-2016, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date after the vaccination, the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, meningitis, pneumonia, cardiovascular event and congestive heart failure. As a result of these symptoms, patient was seen and treated by medical providers and was still under their care. As a result of vaccine live(ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient also had incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of above events was considered as not recovered. The reporter considered the events to be disable and related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, meningitis, pneumonia and congestive heart failure were determined to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: meningitis; pneumonia; cardiovascular event; congestive heart failure; postherpetic neuralgia; multiple outbreaks of herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unspecified age and gender. Information about the patient's concurrent condition, concomitant medication or medical history was not provided. On or about 27-JUL-2016, the patient was inoculated with zoster vaccine live(ZOSTAVAX) (strength, dose, route, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unspecified date after the vaccination, the patient suffered multiple outbreaks of herpes zoster, postherpetic neuralgia, meningitis, pneumonia, cardiovascular event and congestive heart failure. As a result of these symptoms, patient was seen and treated by medical providers and was still under their care. As a result of vaccine live(ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The patient also had incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of above events was considered as not recovered. The reporter considered the events to be disable and related to Zoster Vaccine Live(ZOSTAVAX).  Upon internal review, meningitis, pneumonia and congestive heart failure were determined to be medically significant.
Sex: F
Vaccine: PPV
Symptoms: Periarthritis
Clinical narrative: Received "23 pneumonia vaccine" with an underlying autoimmune condition resulted in frozen shoulder; This spontaneous report was received from a health care professional via Pfizer regarding a female patient of unknown age. The patient's current conditions included an autoimmune disorder. Her medical history included facial paralysis. The patient's drugs reactions or allergies and concomitant medications were not reported.  On an unknown date, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, frequency, route of administration, anatomical injection site, lot number, and expiration date were not reported) as prophylaxis. At the vaccination time, the patient had an underlying autoimmune condition resulted in frozen shoulder (periarthritis).  The outcome of the event was unknown.  The causal relationship between periarthritis and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not provided
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional adverse event reported; temperature excursion for PROQUAD/doses were administered following the excursion; This spontaneous report was received from a physician referring to a 4 year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 29-DEC-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 milliliter for prophylaxis, lot number reported as T021642 and expiration date as 21-DEC-2020 (vaccination scheme, anatomical location, and route of administration were not provided) (product storage error). No additional adverse event reported.     The administered dose of the vaccine experienced a temperature excursion of max. 16.2 Fahrenheit (F) for a timeframe of 2 hours and 28 minutes, as recorded by a digital data logger. It was also reported there was not a previous temperature excursion.
Age: 11.0
Sex: U
Vaccine: HPV9, UNK
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported.; GARDASIL9 was administered during a temperature excursion; Information has been received from a medical assistant, referring to a 11 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 18-DEC-2020, the patient was vaccinated with an improperly stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # S033308, expiration date on 08-APR-2022, 0.5 milliliter (administration route and anatomical location were not reported)for prophylaxis.  The reporting medical assistant stated that the dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was administered during a temperature excursion that was later found supported. No additional adverse events reported. The temperature excursion was 8.5 Celsius degrees (C), during a time frame of 3 minutes. It was confirmed that no previous temperature excursions occurred and no digital data logger was involved. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S033308; expirationdate: 08-APR-2022; 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 suggest a causal association with the device or device constituent
Sex: U
Vaccine: VARZOS
Symptoms: Pemphigoid
Clinical narrative: bullous pemphigoid; This case was reported by a physician via sales rep and described the occurrence of bullous pemphigoid in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the bullous pemphigoid was unknown.   It was unknown if the reporter considered the bullous pemphigoid to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected adult as per vaccine indication. The patient developed bullous pemphigoid after receiving the Shingrix vaccine. The permission to follow up was denied. This case has been linked with US2021AMR001850, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR001850:same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Pemphigoid
Clinical narrative: bullous pemphigoid; This case was reported by a physician via sales rep and described the occurrence of bullous pemphigoid in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced bullous pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the bullous pemphigoid was unknown.   It was unknown if the reporter considered the bullous pemphigoid to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was not reported but it was selected adult as per vaccine indication. The patient developed bullous pemphigoid after receiving the Shingrix vaccine. The permission to follow up was denied. This case has been linked with US2021AMR001842, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR001842:same reporter
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Gastroenteritis viral, Insomnia
Clinical narrative: Chills; Fever; Loss of consciousness x 2; GI upset; Diarrhea; Difficulty sleeping; Pallor; Stomach flu; A spontaneous report was received from a nurse concerning a 31-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of consciousness (LOC) x 2, gastrointestinal (GI) upset, diarrhea, difficulty sleeping, pallor, stomach flu, chills and fever.   The patient's medical history, as provided by the reporter, included allergy to cefaclor and hereditary hemorrhagic telangiectasia. Concomitant medications reported included desvenlafaxine succinate, gabapentin and dexlansoprazole.   On 23 Dec 2020 at 11:30 am, approximately six hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On the morning of 23 Dec 2020, prior to receiving mRNA-1273, the patient felt "achy".  At 5:30 pm, the patient experienced chills, fever to 102, GI upset and diarrhea. At 11:00 pm, the patient reported difficulty sleeping, GI upset, LOC x 2 and pallor. The patient was transported to the emergency room via ambulance.  A COVID-19 polymerase chain reaction test and routine labs were collected; however, results were not provided. Treatment for the events included paracetamol, unspecified intravenous (IV) medications, ondansetron and ketorolac tromethamine. The emergency room discharge diagnosis was stomach flu.  Action taken with mRNA-1273 in response to the events was not reported.   The events, loss of consciousness (LOC) x 2, GI upset, diarrhea, difficulty sleeping, pallor, stomach flu, chills and fever, were considered resolved on 24 Dec 2020.; Reporter's Comments: This case concerns a 31-year-old, male subject with a medical history of hereditary hemorrhagic telangiectasia, who experienced the unexpected events of loss of consciousness (LOC) x 2, gastrointestinal (GI) upset, diarrhea, difficulty sleeping, pallor, and stomach flu, and the expected events of chills and fever. The events of chills, fever occurred approximately 6 hrs. and the events of GI upset, loss of consciousness, difficulty sleeping occurred after 12 hrs. after the first dose of Moderna COVID-19 Vaccine. The time to onset for the events of GI upset and diarrhea were unknown. The reporter did not provide the causality assessment for the events. Due to the temporal association between the LOC and the administration of the vaccine, a causal relationship cannot be excluded, however, the subject's medical history of hereditary hemorrhagic telangiectasia and other concurrent conditions of GI upset, diarrhea, and stomach flu remain as confounders.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of consciousness, Pallor, Pyrexia
Clinical narrative: Chills; Fever; Loss of consciousness x 2; GI upset; Diarrhea; Difficulty sleeping; Pallor; Stomach flu; A spontaneous report was received from a nurse concerning a 31-year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of consciousness (LOC) x 2, gastrointestinal (GI) upset, diarrhea, difficulty sleeping, pallor, stomach flu, chills and fever.   The patient's medical history, as provided by the reporter, included allergy to cefaclor and hereditary hemorrhagic telangiectasia. Concomitant medications reported included desvenlafaxine succinate, gabapentin and dexlansoprazole.   On 23 Dec 2020 at 11:30 am, approximately six hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On the morning of 23 Dec 2020, prior to receiving mRNA-1273, the patient felt "achy".  At 5:30 pm, the patient experienced chills, fever to 102, GI upset and diarrhea. At 11:00 pm, the patient reported difficulty sleeping, GI upset, LOC x 2 and pallor. The patient was transported to the emergency room via ambulance.  A COVID-19 polymerase chain reaction test and routine labs were collected; however, results were not provided. Treatment for the events included paracetamol, unspecified intravenous (IV) medications, ondansetron and ketorolac tromethamine. The emergency room discharge diagnosis was stomach flu.  Action taken with mRNA-1273 in response to the events was not reported.   The events, loss of consciousness (LOC) x 2, GI upset, diarrhea, difficulty sleeping, pallor, stomach flu, chills and fever, were considered resolved on 24 Dec 2020.; Reporter's Comments: This case concerns a 31-year-old, male subject with a medical history of hereditary hemorrhagic telangiectasia, who experienced the unexpected events of loss of consciousness (LOC) x 2, gastrointestinal (GI) upset, diarrhea, difficulty sleeping, pallor, and stomach flu, and the expected events of chills and fever. The events of chills, fever occurred approximately 6 hrs. and the events of GI upset, loss of consciousness, difficulty sleeping occurred after 12 hrs. after the first dose of Moderna COVID-19 Vaccine. The time to onset for the events of GI upset and diarrhea were unknown. The reporter did not provide the causality assessment for the events. Due to the temporal association between the LOC and the administration of the vaccine, a causal relationship cannot be excluded, however, the subject's medical history of hereditary hemorrhagic telangiectasia and other concurrent conditions of GI upset, diarrhea, and stomach flu remain as confounders.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Dysarthria, Dysphagia, Dysphonia
Clinical narrative: Sharp shooting pain up my arm, upper chest, the shoulder, above my brest; Trouble swallowing, slurred speech, red across the chest and hoarse/raspy voice; A report was received from a consumer concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced sharp shooting pain up my arm, upper chest, the shoulder, above my brest, trouble swallowing - could not swallow my saliva, slurry speech, red across my chest, and hoarse/raspy voice.   The patient's medical history included diphenhydramine hydrochloride allergy, shellfish allergy, and latex allergy. Concomitant medications included salbutamol sulfate.    The patient received their first dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection in their right arm on 26 Dec 2020.  Five minutes following administration of the vaccine, the patient felt sharp shooting pains up her arm, upper chest, the shoulder, above the breast. Five to 10 minutes after, the patient had trouble swallowing and began to have slurred speech. The patient was administered epinephrine in her right thigh. Following this, she began to experience redness across the chest and was administered another dose of epinephrine. She also experienced hoarse/raspy voice. The patient was then transported to the emergency room in an ambulance, where she received intravenous fluids and solumedrol after which she began feeling better. The patient was observed in the hospital for several hours and discharged on the same day.    Action taken with mRNA-1273 in response to the event was not reported.    The outcome of the event, sharp shooting pain up my arm, upper chest, the shoulder, above my brest, was unknown. The event, trouble swallowing - could not swallow my saliva, was considered resolved on 26 Dec 2020. The outcome of the event, slurry speech, was unknown. The outcome of the event, red across my chest, was unknown. The outcome of the event, hoarse/raspy voice, was unknown.  The reporter did not provide an assessment for the events, sharp shooting pain up my arm, upper chest, the shoulder, above my brest, trouble swallowing - could not swallow my saliva, slurry speech, red across my chest, or hoarse/raspy voice.; Reporter's Comments: This case concerns a female patient with a medical history of diphenhydramine hydrochloride allergy, shellfish allergy, and latex allergy who experienced the events of pains up her arm, upper chest, the shoulder, hypersensitivity reaction with symptoms of trouble swallowing, slurred speech, erythema of the chest  and hoarse/raspy voice, occurring between five and ten minutes following administration of the first dose of mRNA-1273 vaccine. The patient was treated with 2 shots of epinephrine, was transported to the hospital and received and IV solumedrol, after which symptoms improved. Based on the information provided and temporal association, the event is assessed as possibly related to mRNA-1273. The patient's medical history of multiple allergies could have contributed to the event. Further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pain in extremity
Clinical narrative: Sharp shooting pain up my arm, upper chest, the shoulder, above my brest; Trouble swallowing, slurred speech, red across the chest and hoarse/raspy voice; A report was received from a consumer concerning a patient who was participating in the mRNA-1273 Emergency Use Program and who experienced sharp shooting pain up my arm, upper chest, the shoulder, above my brest, trouble swallowing - could not swallow my saliva, slurry speech, red across my chest, and hoarse/raspy voice.   The patient's medical history included diphenhydramine hydrochloride allergy, shellfish allergy, and latex allergy. Concomitant medications included salbutamol sulfate.    The patient received their first dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection in their right arm on 26 Dec 2020.  Five minutes following administration of the vaccine, the patient felt sharp shooting pains up her arm, upper chest, the shoulder, above the breast. Five to 10 minutes after, the patient had trouble swallowing and began to have slurred speech. The patient was administered epinephrine in her right thigh. Following this, she began to experience redness across the chest and was administered another dose of epinephrine. She also experienced hoarse/raspy voice. The patient was then transported to the emergency room in an ambulance, where she received intravenous fluids and solumedrol after which she began feeling better. The patient was observed in the hospital for several hours and discharged on the same day.    Action taken with mRNA-1273 in response to the event was not reported.    The outcome of the event, sharp shooting pain up my arm, upper chest, the shoulder, above my brest, was unknown. The event, trouble swallowing - could not swallow my saliva, was considered resolved on 26 Dec 2020. The outcome of the event, slurry speech, was unknown. The outcome of the event, red across my chest, was unknown. The outcome of the event, hoarse/raspy voice, was unknown.  The reporter did not provide an assessment for the events, sharp shooting pain up my arm, upper chest, the shoulder, above my brest, trouble swallowing - could not swallow my saliva, slurry speech, red across my chest, or hoarse/raspy voice.; Reporter's Comments: This case concerns a female patient with a medical history of diphenhydramine hydrochloride allergy, shellfish allergy, and latex allergy who experienced the events of pains up her arm, upper chest, the shoulder, hypersensitivity reaction with symptoms of trouble swallowing, slurred speech, erythema of the chest  and hoarse/raspy voice, occurring between five and ten minutes following administration of the first dose of mRNA-1273 vaccine. The patient was treated with 2 shots of epinephrine, was transported to the hospital and received and IV solumedrol, after which symptoms improved. Based on the information provided and temporal association, the event is assessed as possibly related to mRNA-1273. The patient's medical history of multiple allergies could have contributed to the event. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: patient received half of dose from vaccine due to making movement; A spontaneous report was received from a physician concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced incorrect dose administered.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 24 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011j20a)intramuscularly for prophylaxis of COVID-19 infection.   On 24 Dec 2020, during vaccine administration, the patient experienced incorrect dose administered. The physician reported the patient moved while being given the vaccine and about half of the dose was injected and the other half was not. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The event, incorrect dose administered, was considered resolved on 24 Dec 2020.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot 011j20A), reporting Incorrect dosage administered without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Received a subcutaneous injection; A spontaneous report was received from a healthcare professional concerning a patient who was who received Moderna's COVID-19 vaccine and received a subcutaneous injection.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On an unreported date in Dec 2020, the patient received their first of two planned doses of mRNA-1273 subcutaneously for prophylaxis of COVID-19 infection.  On an unreported date in Dec 02020, the patient received a subcutaneous injection. No treatment information was provided.  Action taken with mRNA-1273 in response to the event, received a subcutaneous injection, was not reported.  The event, received a subcutaneous injection, was considered resolved on an unreported date in Dec 2020.  The reporter did not provide an assessment for the event, received a subcutaneous injection.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date not provided), who experienced an unexpected event of wrong route of administration. The patient details and time to onset for the events was unknown. The reporter did not provide the causality assessment for the events. However, wrong route of administration is more of a human error and it was unlikely related to Moderna COVID-19 Vaccine.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest pain, Dyspnoea, Erythema, Fatigue
Clinical narrative: generalized itchiness; woke up with headache; feeling fatigued; anaphylactic reaction; right arm started going numb; right arm was tingling; A spontaneous report was received from a 26-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, right arm numbness and tingling, headache, fatigue, and generalized itchiness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: OU520A/011520A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 23 Dec 2020, within minutes of receiving the vaccine, the patient experienced an anaphylactic reaction and was rushed to the emergency room (ER). When transported to the ER she began to experience throat swelling, redness of arms and chest, trouble breathing with lower chest pain shooting into lungs, and numbness with tingling in her right arm. Treatment for the event included epinephrine, steroids, and diphenhydramine.  She was released from the ER on 23 Dec 2020.  On 24 Dec 2020 patient awoke with a headache, fatigue, and generalized itchiness. Treatment for the event included ibuprofen and diphenhydramine.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, anaphylactic reaction, right arm numbness and tingling, were reported as resolved on 23 December 2020. The events of headache, fatigue, and generalized itchiness were considered resolving.; Reporter's Comments: This case concerns a 26-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot OU520A/011520A), and who experienced the unlisted events of anaphylactic reaction, right arm numbness and tingling, and generalized itchiness, and the listed events of headache and fatigue.  The events were considered to be possibly related to the vaccine due to the temporal relationship with onset on the day of vaccination.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia, Pain, Paraesthesia, Pharyngeal swelling
Clinical narrative: generalized itchiness; woke up with headache; feeling fatigued; anaphylactic reaction; right arm started going numb; right arm was tingling; A spontaneous report was received from a 26-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, right arm numbness and tingling, headache, fatigue, and generalized itchiness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: OU520A/011520A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 23 Dec 2020, within minutes of receiving the vaccine, the patient experienced an anaphylactic reaction and was rushed to the emergency room (ER). When transported to the ER she began to experience throat swelling, redness of arms and chest, trouble breathing with lower chest pain shooting into lungs, and numbness with tingling in her right arm. Treatment for the event included epinephrine, steroids, and diphenhydramine.  She was released from the ER on 23 Dec 2020.  On 24 Dec 2020 patient awoke with a headache, fatigue, and generalized itchiness. Treatment for the event included ibuprofen and diphenhydramine.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, anaphylactic reaction, right arm numbness and tingling, were reported as resolved on 23 December 2020. The events of headache, fatigue, and generalized itchiness were considered resolving.; Reporter's Comments: This case concerns a 26-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot OU520A/011520A), and who experienced the unlisted events of anaphylactic reaction, right arm numbness and tingling, and generalized itchiness, and the listed events of headache and fatigue.  The events were considered to be possibly related to the vaccine due to the temporal relationship with onset on the day of vaccination.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pulmonary pain
Clinical narrative: generalized itchiness; woke up with headache; feeling fatigued; anaphylactic reaction; right arm started going numb; right arm was tingling; A spontaneous report was received from a 26-year-old, female consumer who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, right arm numbness and tingling, headache, fatigue, and generalized itchiness.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 23 Dec 2020 prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: OU520A/011520A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.     On 23 Dec 2020, within minutes of receiving the vaccine, the patient experienced an anaphylactic reaction and was rushed to the emergency room (ER). When transported to the ER she began to experience throat swelling, redness of arms and chest, trouble breathing with lower chest pain shooting into lungs, and numbness with tingling in her right arm. Treatment for the event included epinephrine, steroids, and diphenhydramine.  She was released from the ER on 23 Dec 2020.  On 24 Dec 2020 patient awoke with a headache, fatigue, and generalized itchiness. Treatment for the event included ibuprofen and diphenhydramine.  Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome for the events, anaphylactic reaction, right arm numbness and tingling, were reported as resolved on 23 December 2020. The events of headache, fatigue, and generalized itchiness were considered resolving.; Reporter's Comments: This case concerns a 26-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot OU520A/011520A), and who experienced the unlisted events of anaphylactic reaction, right arm numbness and tingling, and generalized itchiness, and the listed events of headache and fatigue.  The events were considered to be possibly related to the vaccine due to the temporal relationship with onset on the day of vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood potassium decreased, Chest discomfort, Dysgeusia, Headache
Clinical narrative: Anaphylactic reaction; Chest pressure; Rash (on neck,belly and arm); Metallic taste in mouth; Hot flashes; Headaches; A spontaneous report  was received from a 49-year-old female nurse, who was also a patient, who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headaches.  The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 22 Dec 2020, at 7:00 pm, approximately 15 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 22 Dec 2020, approximately 15 minutes after the mRNA-1273 vaccination, the patient experienced anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headaches. She was taken immediately to the emergency room. Laboratory values included a negative troponin level and low potassium at 3.3. All other laboratory results were normal. Treatment included prednisone for five days, diphenhydramine hydrochloride, famotidine and paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events, anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headaches was not reported   The causality assessment for the events, anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headache was not reported.; Reporter's Comments: This case concerns a 49-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), reporting an unexpected event of anaphylactic reaction, chest pressure, rash, metallic taste in mouth, hot flush and an expected event of headache. The events occurred the same day, 15 minutes after vaccine administration. The reporter did not provide the causality assessment for the events. Due to the temporal association between the events and administration of the vaccine, a causal relationship cannot be excluded, and the events are assessed as possibly related to vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Rash, Troponin normal
Clinical narrative: Anaphylactic reaction; Chest pressure; Rash (on neck,belly and arm); Metallic taste in mouth; Hot flashes; Headaches; A spontaneous report  was received from a 49-year-old female nurse, who was also a patient, who received Moderna's COVID-19 vaccine and experienced anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headaches.  The patient's medical history was not provided.  No relevant concomitant medications were reported.  On 22 Dec 2020, at 7:00 pm, approximately 15 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 22 Dec 2020, approximately 15 minutes after the mRNA-1273 vaccination, the patient experienced anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headaches. She was taken immediately to the emergency room. Laboratory values included a negative troponin level and low potassium at 3.3. All other laboratory results were normal. Treatment included prednisone for five days, diphenhydramine hydrochloride, famotidine and paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events, anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headaches was not reported   The causality assessment for the events, anaphylactic reaction, chest pressure, rash (on neck, belly and arm), metallic taste in mouth, hot flashes and headache was not reported.; Reporter's Comments: This case concerns a 49-year-old, female patient who received their first of two planned doses of mRNA-1273 (Lot-# and expiration date -unknown), reporting an unexpected event of anaphylactic reaction, chest pressure, rash, metallic taste in mouth, hot flush and an expected event of headache. The events occurred the same day, 15 minutes after vaccine administration. The reporter did not provide the causality assessment for the events. Due to the temporal association between the events and administration of the vaccine, a causal relationship cannot be excluded, and the events are assessed as possibly related to vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered
Clinical narrative: Did not receive the full dose; Vaccine leaked on arm; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and did not receive the full dose and vaccine leaked on arm.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot #025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.   On 23 Dec 2020, during vaccine administration, the pharmacist reported that the vaccine leaked on the patient's arm and that the patient did not receive the full dose. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The events, did not receive the full dose and vaccine leaked on arm, were considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns a patient of unreported age and sex. The subject medical history is not provided. The patient experienced an unexpected event of not receiving the full dose and vaccine leaked on arm.  The event occurred on 23 Dec 2020 during administration of the first dose of the  mRNA-1273 (Lot #025J20-2A). The event is considered not related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactoid reaction
Clinical narrative: Anaphylactic type of reaction; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced an anaphylactic type of reaction.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, after receiving the Moderna vaccine, patient reported that she had some adverse side effects and believed she needed an Epi-pen before getting a second dose due to the anaphylactic type of reaction she had. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, anaphylactic type of reaction, was not reported.; Reporter's Comments: This case concerns a female patient of unreported age.  The patient's medical history is not provided. The patient experienced an unexpected event of anaphylactic type of reaction.  The event occurred on an unknown date and unknown duration after receiving the first dose of mRNA-1273. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the event, a causal relationship cannot be excluded. Additional information about the event details are required for further assessment.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: itching in her arms, face, neck and her trunk; redness of the skin; This is a spontaneous report from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). A contactable physician reported that a 23-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from Dec2020 at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  It was reported that this patient was given the first dose of COVID-19 vaccine within the last week.  The patient experienced itching in her arms, face, neck and her trunk, redness of the skin with no airway problem after her first dose (Dec2020). Patient took Benadryl for the symptoms and they went away completely within minutes. The patient was told that they cannot get the second shot. So the doctor wanted to find out if that information was true or not; if they could get that second shot. Outcome of events was recovered.  No follow-up attempts possible. No further information expected. The following information on the batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I developed symptoms on 29Dec2020 and test obtained on 30Dec2020. My results are back today and I'm positive.; I developed symptoms on 29Dec2020 and test obtained on 30Dec2020. My results are back today and I'm positive.; This is a spontaneous report from a contactable other HCP (healthcare professional) who reported for himself. A male patient of unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on 16Dec2020 (at an unspecified age) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient tested positive for coronavirus on 30Dec2020. It was reported that the patient obtained his first Pfizer vaccine dose on 16Dec2020. The patient reported that he was a physician assistant and worked in a dedicated COVID patient care area. The patient developed symptoms on 29Dec2020, and a test was obtained on 30Dec2020. The patient's results were back "today" and he was positive. The patient was scheduled for his second dose of the vaccine on 06Jan2021. He reported that he would cancel that because he would still be in his 10-day isolation period. Given those circumstances, the patient inquired as to "when would be the most ideal time to obtain my second dose of the vaccine? When should I take my second dose of the vaccine if I contracted COVID after receiving the first dose?" The clinical outcome of the event "I developed symptoms on 29Dec2020, and test obtained on 30Dec2020. My results are back today and I'm positive" was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on a compatible temporal asociation, a causal relationship between event "patient developed symptoms on 29Dec2020 and test obtained on 30Dec2020. was positive" (coded to Drug ineffective / COVID-19) and BNT162B2 vaccine cannot be completely excluded.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event, SARS-CoV-2 test positive
Clinical narrative: person then became symptomatic and tested positive within 7 days of receiving the vaccine; person then became symptomatic and tested positive within 7 days of receiving the vaccine; This is a spontaneous report from a contactable pharmacist.  A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE lot number and expiration date unknown) via an unspecified route of administration on an unspecified date (at an unknown age) at an unknown dose for COVID-19 vaccination. The patient's medical history was not reported. The patient's concomitant medications were not reported. The patient became symptomatic and tested positive within seven (7) days of receiving the COVID-19 vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The clinical outcome was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Based on the information available, a possible contributory role of the suspect products cannot be excluded for the reported event of positive for corona virus infection for the lack of efficacy of the vaccine. However, based on the mechanism of action of the vaccine, it is unlikely the patient would have fully developed immunity for the vaccine to be effective, due to the number of days passed since the vaccine is given. Case will be reevaluated based on follow-up information
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: Complete loss of smell and taste; Complete loss of smell and taste; This is a spontaneous report from a contactable physician reported for herself. A 37-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; brand: PfizerbioNtech, lot number: EH9888) intramuscularly at left arm on 17Dec2020 at 03:00 PM at a single dose (dose number: 1) for COVID-19 immunization. Medical history was reported as none. No known allergies (no allergies to medications, food, or other products). The patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Facility where the most recent COVID-19 vaccine was administered was at hospital. The patient experienced adverse event complete loss of smell and taste on 19Dec2020 at 07:00 AM. The event was considered as serious due to resulted in disability or permanent damage. No treatment received for the event. The outcome of event was not resolved. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.; Sender's Comments: Based on the current available information and the plausible drug-event temporal association, a possible contributory role of the suspect product BNT162B2 to the development of events complete loss of smell and taste cannot be totally excluded.  The case will be reassessed if additional information becomes 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.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Gastrointestinal disorder
Clinical narrative: Stomach cramps; frequent loose stools; GI issues; This is a spontaneous report from a contactable physician, the patient. A 37-year-old female received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), intramuscular in the left arm on 16Dec2020 at 12:00 (at the age of 37-years-old) as a single dose for COVID-19 immunization. Medical history and concomitant medications were reported as none. The patient had no known allergies to medications, food, or other products. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. On 16Dec2020 at 21:30 the patient experienced gastrointestinal issues, stomach cramps and frequent loose stools reported as beginning several hours after the vaccination and lasting until the next day. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the gastrointestinal issues, stomach cramps and frequent loose stools was resolved on 17Dec2020.  Information on the Lot/Batch number has been requested