chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: VARlVAX was improperly stored and administered; This spontaneous report was received from other health professional referring to a 1-year-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 04-JAN-2021, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T021824, expiration date 25-JUN-2022 for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).    The vaccine was stored in a temperature of 16.1 degree Fahrenheit (°F) for 1 hour and 45 minutes as recorded by a data logger. There was no previous temperature excursion reported.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Product storage error
Clinical narrative: No additional adverse events reported; A dose of MMRlI and VARIVAX was given to a patient during a temperature excursion; This spontaneous report was received from a medical assistant concerning to a 3-days-old patient (discrepant information) of an unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.         On 04-JAN-2020 (discrepant information), the patient was vaccinated with improperly stored doses of measles (+) mumps (+) rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II), 0.5 milliliter (ml) for prophylaxis, lot number reported as S029456 and expiration date as 19-SEP-2021 (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided); and varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter for prophylaxis, lot number reported as T020650 and expiration date as 16-JUN-2022 (formulation, strength, vaccination scheme, route of administration and anatomical site of vaccination were not provided). No additional adverse events were reported.  The administered vaccines had a temperature excursion of 5.6 degrees Celsius (°C) for a time frame of 16 hours and 20 minutes later found supported. There was not a digital data logger involved. It was also reported there was not a previous temperature excursion.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; doses were administered following the excursion; This spontaneous report was received from a physician referring to a 4-year-old patient. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.     On 14-DEC-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) lot # T021642, expiration date 21-DEC-2021, at a dose of 0.5 milliliter for prophylaxis (vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported).   The vaccine was stored in a temperature of 16.2 degree Fahrenheit (°F) for 1 hour 14 minutes as recorded by a data logger. There was no previous temperature excursion reported.
Age: 31.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: dose of MMRlI was administered to a patient yesterday 01/06/2021 (Expiration Date: 10/24/2020); No additional adverse events reported; This spontaneous report was received from a pharmacist, referring to a 31-year-old patient of unknown gender.   Information regarding the patient's medical history, concurrent conditions or concomitant medications was unknown.  On 06-JAN-2021 the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) 0.5 milliliter (strength, route of administration, and anatomical location were not reported; lot number R030812 and expiration date 24-OCT-2020).   No additional adverse events reported.  The outcome of expired dose administered was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Varivax was administered to a patient after improper storage; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender.     The patient's concurrent conditions, medical history and concomitant therapies were not provided.  On an unknown date, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) (dose, route, and anatomical location unknown) lot # T017686, expiration date 21-MAY-2022, 1 dosage form, for prophylaxis.     On 06-JAN-2021, it was noticed the patient had been vaccinated with an inappropriately stored varicella virus vaccine live (oka/merck)(VARIVAX) vaccine.  The vaccine was stored at a temperature of -12°C for 11 hours and 10 min. Also, there was a previous temperature excursion of -14°C to 10°C for 2 hours and 30 minutes. The error was noticed due to a data logger. The patient did not have an adverse event.
Sex: U
Vaccine: VARZOS
Symptoms: Rheumatoid arthritis, Synovial cyst
Clinical narrative: rheumatoid arthritis; ganglion cysts; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 28-JAN-2014, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: rheumatoid arthritis, and ganglion cysts (synovial cyst).  The patient claimed damages as result of injury to themselves, and economic losses.The outcome of the events was not provided. Therefore, the causality for the events was related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of rheumatoid arthritis was considered to be medically significant.
Sex: U
Vaccine: VARZOS
Symptoms: Cardiac failure congestive, Dyspnoea, Rash
Clinical narrative: congestive heart failure; rashes; shortness of breath; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 13-AUG-2012, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: rashes, shortness of breath (dyspnea), and congestive heart failure (cardiac failure congestive). The patient claimed damages as result of injury to themselves, and economic losses.The outcome of the events was not provided. Therefore, the causality for the events was related to zoster vaccine live (ZOSTAVAX).  Upon internal review, the event of cardiac failure congestive was considered to be medically significant.
Sex: U
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Received the first dose of Heplisav-B, then received 2nd dose with Engerix; Initial Report Received on 24-Nov-2020  A registered nurse reported that a 44-year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for the first dose of hepatitis B immunization and received ENGERIX-B as the second dose.  The patient has no reported know drug allergies.   No concomitant medications were reported.  On 28-Oct-2020, the first dose of HEPLISAV-B (Lot # 933837, expiration date 08-May-2021, Serial # 375853594193) was administered to the left deltoid.    On 24-Nov-2020, the second dose of a hepatitis B vaccine, Engerix-B (Lot # 5L27A, expiration date 11-Feb-2022), was administered to the left deltoid.    At the time of report, no adverse reactions to either injections had been noted.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Heplisav-B given for first dose, Engerix-B was given for second dose; Initial Report Received on 04-Dec-2020  A pharmacy manager reported that a 63 year-old male (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for the first dose of hepatitis B immunization and received ENGERIX-B for the second dose.  No medical history included penicillin allergy.  No concomitant medications were reported.  On 08-Oct-2020, the patient received the first dose of HEPLISAV-B (Lot # 934259, expiration date 25-Sep-2021 and NDC # not reported) to the left deltoid at the pharmacy.  On onset 19-Nov-2020, the patient was given ENGERIX-B (Lot # 5NY2K, expiration date 29-May-2022 and MDC # not reported) to the right deltoid at his doctor's office.  The patient did not report any adverse reactions to either vaccination.  No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered to Newborn; Vaccine administered at inappropriate site; Initial Report Received on 15-Dec-2020  A pharmacist reported that a newborn female (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history or known drug allergies were reported.   No concomitant medications were reported.  On 09-Dec-2020, on the day of birth, the patient received a dose of HEPLISAV-B (Lot # 933839, expiration date 28-Feb-2021 and NDC # not reported) to the right thigh.  At the time of report, no adverse reactions had been reported.  No additional information was reported.    Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Administered to Newborn; Vaccine administered at inappropriate site; Initial Report Received on 15-Dec-2020  A pharmacist reported that a newborn female patient (race and ethnicity not provided) received HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  No medical history or known drug allergies were reported.   No concomitant medications were reported.  On 09-Dec-2020, on the day of birth, the patient received a dose of HEPLISAV-B (Lot # 933839, expiration date 28-Feb-2021 and NDC # not reported) to the left thigh.  At the time of report, no adverse reactions had been reported.  No additional information was reported.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Wrong product administered
Clinical narrative: Received Engerix-B for Second Injection; Initial Report Received on 31-Dec-2020  A registered nurse, reported that that a 60-year-old female, received HEPLISAV-B for hepatitis B immunization.  The patient has a medical history significant for allergies to Demerol (meperidine), scopolamine patches, sulfa, contrast dye, cats, dogs, dust mites, mold, ragweed trees, weeds and sunflower seeds.  On 11-Nov-2020, the patient received dose 1 of HEPLISAV-B in the left deltoid (Lot #934598, expiration date 25-Feb-2022, serial number not available).  On 30-Dec-2020, the patient received dose 2 of a hepatitis B vaccine but was administered Engerix-B (Lot # and expiration date not available).    The patient reported no adverse reactions to either injection.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Given a first dose of the Moderna vaccine of 1ml instead of .5 ml; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was given a first dose of the Moderna vaccine of 1 mL instead of 0.5 mL.   The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 29 Dec 2020 intramuscularly for prophylaxis of COVID-19 infection. During the administration, the pharmacist stated that the patient was given a first dose of the vaccine of 1.0 ml instead of 0.5 ml. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event was not reported.; Reporter's Comments: This case concerns a male patient who received their first of two planned doses of mRNA-1273 (Lot 011L20A), reporting Incorrect dosage administered without any associated adverse events.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Hypertension, Malaise, Pallor, Throat tightness
Clinical narrative: Throat tightness; not feeling well; Upper chest pressure; A spontaneous report was received from a pharmacist concerning a 52-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced throat tightness, upper chest pressure and was not feeling well.  The patient did not have any relevant medical history. The patient denied any previous history of adverse reactions to vaccines. No relevant concomitant medications were reported.  On 23 Dec 2020 at 09:40 am, approximately five minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the arm for prophylaxis of COVID-19 infection.   On 23 Dec 2020 at 9:45 am, the patient experienced throat tightness and not feeling well. The patient was pale and hypertensive. She was carried on a stretcher and placed on oxygen. Rapid response team was called in and treatment with intravenous (iv) fluids including iv push of famotidine at a dose of 20 mg was initiated. Patient was transported to the Emergency Department (ED) for further evaluation. Additionally, the patient received iv treatment with methylprednisolone succinate at a dose 125 mg and diphenhydramine at a dose of 25 mg. Throat tightness and upper chest pressure were reported to be relieved. The patient was discharged with prescriptions for oral prednisone, famotidine, and diphenhydramine to be taken as needed for recurrent symptoms.  Action taken with mRNA-1273 in response to the events of  throat tightness, upper chest pressure, and not feeling well was not reported.   The events, throat tightness, upper chest pressure, and not feeling well were considered resolved on an unknown date.; Reporter's Comments: This case concerns a 52-year-old, female subject who received their first of two planned doses of mRNA-1273 (Lot 039K20A), experienced the unexpected events of not feeling well; upper chest pressure and not feeling well. The onset of events occurred 5 min after the first dose of vaccine administration. The reporter causality assessment for the events was not provided. Due to the temporal association between the events and the administration of vaccine, a causal relationship cannot be excluded, and the events are assessed as possibly related to vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered
Clinical narrative: Some of the liquid came out of arm when they removed the needle after vaccine administration; Did not have any reaction on the skin that was exposed to the vaccine; A report was received from a nurse concerning male patient of unknown age who received Moderna's COVID-19 vaccine and experienced some of the liquid came out of arm when they removed the needle after vaccine administration and did not have any reaction on the skin that was exposed to the vaccine.  The patient's medical history was not provided. No relevant concomitant medications were reported.   The patient received their first of two planned doses of mRNA-1273 on 27 Dec 2020.   On 27 Dec 2020, just prior to onset of the events, the patient received their first of the two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 27 Dec 2020, the reporter stated that some of the liquid came out of the arm when they removed the needle after administration of the vaccine. It was reported that the patient did not have any reaction on the skin that was exposed to the vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The events, some of the liquid came out of arm when they removed the needle after vaccine administration and did not have any reaction on the skin that was exposed to the vaccine, were considered resolved on 27 Dec 2020.; Reporter's Comments: This case concerns a male patient who received their first of two planned doses of mRNA-1273 (Lot 037K20A), reporting Incomplete dose administered and exposure via skin contact without any associated adverse events. Both the events occurred same day after the first dose of Moderna COVID-19 Vaccine. The reporter did not provide the causality assessment for the events.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Muscle rigidity, Muscle tightness
Clinical narrative: Rigidity all over; All muscles were clenched up; BP was 170; Heart rate elevated; A spontaneous report was received from a pharmacist concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced rigidity all over, all muscles were clenched up, BP was 170, and heart rate elevated.  The patient's medical history, as provided by the reporter, was unremarkable with no history of allergies or seizures/epilepsy. No relevant concomitant medications were reported.   On 28 Dec 2020, ten minutes prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 28 Dec 2020, ten minutes after vaccination, the patient had rigidity all over and all her muscles were noted to be clenched up.  There was no loss of consciousness and the patient claimed that she was still able to hear the people around her. Her blood pressure at the time was 170 and her heart rate was noted to be elevated. Her temperature was 98 degree Fahrenheit. Treatment for the event included oral diphenhydramine which caused her condition to subside. After an unspecified period of time, the rigidity recurred and the patient was taken to the emergency room.   Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, rigidity all over, all muscles were clenched up, BP was 170, and heart rate elevated were not reported.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), and who experienced the serious unlisted events of Muscle rigidity and Muscle tightness and the non-serious unlisted events of BP was 170 and heart rate elevated.  The events occurred 10 minutes after vaccination and treatment with oral diphenhydramine was administered.  Based on temporal association between the use of the product and the onset of events, a causal relationship cannot be excluded and the events are considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Injection site pain, Product selection error
Clinical narrative: During vaccination, some vaccine leaked out; Nurse said she drew up more than the recommended dose, to allow for leak; Pain in injection site and tenderness; A spontaneous report was received from a physician who was a 55 year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced during vaccination, some vaccine leaked out; nurse said she drew up more than the recommended dose, to allow for leak; and pain in injection site and tenderness.    The patient's medical history was not provided. Concomitant product use was not provided.   On 26 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 039K20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 26 Dec 2020, during the vaccination, some vaccine leaked out, but the administering nurse said she drew up more than the recommended dose, to allow for the leak. The patient believed she received 0.45 - 0.48 ml of the dose. She also experienced pain in the injection site and tenderness and the symptoms went away the same day. No treatment was reported.   Action taken with mRNA-1273 in response to the events was not reported.   The events, during vaccination, some vaccine leaked out; nurse said she drew up more than the recommended dose, to allow for leak; and pain in injection site and tenderness, were considered resolved on 26 Dec 2020.; Reporter's Comments: This report refers to a case of incorrect dose administered and product selection error for mRNA-1273 (Lot number: 039K20A) and concerns a 55 year-old, female patient, who experienced the event of injection site pain. The event occurred the same day after the first dose of mRNA-1273 vaccine administration. Based on the current available information and temporal association between the use of the product and the start of the event, a causal relationship cannot be excluded.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Device use issue
Clinical narrative: Some dose came out of needle attached to syringe when injecting; A spontaneous report was received from a nurse concerning a 44-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, some dose came out of the needle attached to the syringe while injecting the vaccine.  The patient's medical history was not provided. Concomitant product use was not reported.  On 29 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot number: 037K20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.  On 29 Dec 2020, while the vaccine was being administered, some dose came out of the needle attached to the syringe. It was unknown how much vaccine was administered or how much was spilled. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the event, some dose came out of the needle attached to the syringe while injecting the vaccine, was considered resolved on 29 Dec 2020.; Reporter's Comments: This report refers to a case of 44- year-old female patient who experienced event of administered, some dose came out of the needle attached to the syringe  for mRNA-1273, lot # 037K20A. There were no reported AEs associated with this case of some dose came out of the needle attached to the syringe .
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Some of the vaccine leaked out and dripped on her arm; A spontaneous report was received from a 45-year-old, female patient who is an occupational therapist who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, incorrect dose administered.   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 (Lot number:B11J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 29 Dec 2020, during the administration of the vaccine, the administrator used the pinch method and some of the vaccine leaked out and dripped on her arm. The reporter stated they are still determining if she received the full dose or less than the full dose. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, incorrect dose administered, was considered resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a 45-year-old female patient who received their first of two planned doses of mRNA-1273 (Lot B11J20A), reporting Incorrect dose administered without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered 1mL doses instead of 0.5mL dose; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered 1mL dose instead of 0.5mL dose.  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 29 Dec 2020, after vaccine administration, the nurse called to report that the patient had been administered a 1mL dose instead of 0.5mL dose of the vaccine. No side effects were reported due to the event. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, administered 1mL dose instead of 0.5mL dose, was considered resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a patient of unknown age and gender The patient's medical history is not provided. The patient experienced an unexpected event of inappropriate dose of vaccine administered (1ml instead of recommended 0.5ml).  The event occurred on 29 Dec 2020 during the administration of first dose of mRNA-1273. The patient did not have any side effects. The sponsor considered the event as not related to mRNA-1273.
Sex: F
Vaccine: COVID19
Symptoms: Device use issue, Exposure via skin contact
Clinical narrative: Device use issue; Needle popped off and some vaccine leaked on arm; A spontaneous report was received from a surgical technician who was a 48-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the needle popped off and some vaccine leaked on her arm and not sure if she got the full dose.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received ther first of two planned doses of mRNA-1273 intramuscularly in her left arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, during administration of the vaccine, the needle popped off and some of the vaccine leaked on her arm. She thought that the needle was not on tight and she was not sure if she got the full dose. There was no reaction on her arm and her healthcare provider was not aware of the incident. Her provider told her to come back for the second dose in one month. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, the needle popped off and some vaccine leaked on her arm and not sure if she got the full dose, were resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a 48 year old female subject  who experienced an unexpected event of not sure if she got the full dose.  The event occurred on 29 Dec 2020 during administration of the first dose of the mRNA-1273 vaccine .  There were no reported AEs associated with this case of not sure if she got the full dose.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Facial paralysis, Grip strength decreased, Headache, Hemiplegia
Clinical narrative: complete paralysis on the left side of her body and felt like it was bell's palsy; complete paralysis of the left side of her body and felt like it was bell's palsy; forearm, thumb, and pointer finger feels tingly; can't get a grip on things; Chills; headache; A spontaneous report was received from a 51-year-old, female consumer, who was also the patient, who received Moderna's COVID-19 vaccine and experienced the events, complete paralysis on the left side of her body and felt like it was bell's palsy, forearm, thumb and pointer finger feels tingly, can't get a grip on things, chills, and headache.   The patient reported a history of anaphylactic shock, but had not experienced an episode in about 10 years. Concomitant product use was not reported.    On 27 Dec 2020, approximately two hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Dec 2020, about two hours after receiving the vaccine, the patient felt chills and had a headache. The patient went to sleep and woke up to complete paralysis on the left side of her body and felt like it was bell's palsy. Since 27 Dec 2020, the patient's forearm, thumb, and pointer finger have felt tingly and she can't get a grip on things. Treatment for the events included ibuprofen.   Action taken with mRNA-1273 in response to the event was unknown.   The events forearm, thumb and pointer finger feels tingly and can't get a grip on things were considered not resolved. The outcome for the events, complete paralysis on the left side of her body and felt like it was bell's palsy, chills, and headache was unknown.; Reporter's Comments: This case concerns a 51-year-old, female subject with medical history of anaphylactic shock, who experienced a serious, unexpected events of hemiplegia and facial paralysis; and non-serious, unexpected events of paresthesia, motor dysfunction; and non-serious, expected events of chills and headache. The events of hemiplegia, facial paralysis, paresthesia, and motor dysfunction occurred same day of mRNA-1273 (lot # unknown) administration. The event of chills and headache occurred 2 hours after the vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Motor dysfunction, Paraesthesia
Clinical narrative: complete paralysis on the left side of her body and felt like it was bell's palsy; complete paralysis of the left side of her body and felt like it was bell's palsy; forearm, thumb, and pointer finger feels tingly; can't get a grip on things; Chills; headache; A spontaneous report was received from a 51-year-old, female consumer, who was also the patient, who received Moderna's COVID-19 vaccine and experienced the events, complete paralysis on the left side of her body and felt like it was bell's palsy, forearm, thumb and pointer finger feels tingly, can't get a grip on things, chills, and headache.   The patient reported a history of anaphylactic shock, but had not experienced an episode in about 10 years. Concomitant product use was not reported.    On 27 Dec 2020, approximately two hours prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 27 Dec 2020, about two hours after receiving the vaccine, the patient felt chills and had a headache. The patient went to sleep and woke up to complete paralysis on the left side of her body and felt like it was bell's palsy. Since 27 Dec 2020, the patient's forearm, thumb, and pointer finger have felt tingly and she can't get a grip on things. Treatment for the events included ibuprofen.   Action taken with mRNA-1273 in response to the event was unknown.   The events forearm, thumb and pointer finger feels tingly and can't get a grip on things were considered not resolved. The outcome for the events, complete paralysis on the left side of her body and felt like it was bell's palsy, chills, and headache was unknown.; Reporter's Comments: This case concerns a 51-year-old, female subject with medical history of anaphylactic shock, who experienced a serious, unexpected events of hemiplegia and facial paralysis; and non-serious, unexpected events of paresthesia, motor dysfunction; and non-serious, expected events of chills and headache. The events of hemiplegia, facial paralysis, paresthesia, and motor dysfunction occurred same day of mRNA-1273 (lot # unknown) administration. The event of chills and headache occurred 2 hours after the vaccine administration. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Drug administered in wrong device, Incorrect route of product administration
Clinical narrative: Person giving me the injection gave it to me in behind my arm, above elbow in the triceps area I know it was subQ; They said it was a 30 gauge needle; A spontaneous report was received from a female nurse who was also the patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and person giving me the injection gave it to me in behind my arm, above elbow in the triceps area I know it was subQ and they said it was a 30 gauge needle.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 29 Dec 2020, the patient received her first of two planned doses of mRNA-1273 subcutaneously in the arm for prophylaxis of COVID-19 infection.  On 29 Dec 2020, the patient stated she was given the vaccine injection behind her arm, above the elbow, in the triceps area, subcutaneously.  She was also suspicious of the size of the needle used. She was told it was a 30-gauge needle that was supplied by Moderna. The patient stated she was a nurse practitioner and had given over hundreds of injections during her career and was certain her injection was not intramuscular. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The events, person giving me the injection gave it to me in behind my arm, above elbow in the triceps area I know it was subQ and they said it was a 30 gauge needle, were considered resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a female patient who received their first of two planned doses of mRNA-1273 (Lot unknown), reporting Incorrect route of product administration and Drug administration in wrong device without any associated adverse events.
Sex: F
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy; A spontaneous report was received from a nurse, who was a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Bell's palsy.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date, within three days after vaccine administration, the reporter stated that she went to the doctor because she had problems with the whole left side of her face. The patient reported she has Bell's palsy now, she cannot smile. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, Bell's palsy, was unknown.  The reporter assessed the event, Bell's palsy, as related to mRNA-1273.; Reporter's Comments: This case concerns a female patient, who experienced a serious unexpected event of facial paralysis. The event of facial paralysis occurred approximately 3 days after the first dose of mRNA-1273 (Lot# unknown) administration. Very limited information regarding this event has been provided at this time.  Based on temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Administered 1mL doses instead of 0.5mL dose; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and was administered 1mL dose instead of 0.5mL dose.   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 29 Dec 2020, after vaccine administration, the nurse called to report that the patient had been administered a 1mL dose instead of 0.5mL dose of the vaccine. No side effects were reported due to the event. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, administered 1mL dose instead of 0.5mL dose, was considered resolved on 29 Dec 2020.; Reporter's Comments: This case concerns a patient of unknown age and gender The patient's medical history is not provided. The patient experienced an unexpected event of inappropriate dose of vaccine administered (1ml instead of recommended 0.5ml).  The event occurred on 29 Dec 2020 during the administration of first dose of mRNA-1273. The patient did not have any side effects. The sponsor considered the event as not related to mRNA-1273.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swollen L clavicular lymph node 3 x 2 cm; This is a spontaneous report from a contactable healthcare professional (patient). A 20-year-old female patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EJ1685; Expiration date was not reported) on 28Dec2020 (08:30) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included asthma; allergies with raw fruits and vegetables; allergies with almonds; and allergies with shellfish. Concomitant medications included venlafaxine; and ethinylestradiol, norgestimate (ORTHO TRI-CYCLEN). On 03Jan2021, the patient had swollen left clavicular lymph node (3x2 cm). The adverse event resulted in doctor/healthcare professional office/clinic visit and emergency room/department or urgent care. The patient did not receive any treatment for the adverse event. The patient was not diagnosed with COVID-19 prior to vaccination. COVID test was negative on 01Jan2021. The outcome of the event, swollen left clavicular lymph node (3x2 cm), was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pain in extremity, Pyrexia
Clinical narrative: pain in her arm; a little headache; low grade temperature; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on 05Jan2021 at a single dose (2nd dose) for Covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took her first dose of bnt162b2 for Covid-19 immunization on an unspecified date. On 05Jan2021, yesterday,  the patient received her 2nd dose of the vaccine. She has pain in her arm, a little headache and low grade temperature on an unspecified date in Jan2021. The patient was asking if there is any contra-indication with acetaminophen (TYLENOL). Outcome of the events was unknown.  Information about lot/batch number has been requested.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Sore left arm for 24 hours. Ache body and headache for 12 hours.; Sore left arm for 24 hours. Ache body and headache for 12 hours.; Sore left arm for 24 hours. Ache body and headache for 12 hours.; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899), via an unspecified route of administration at the left arm on 29Dec2020 18:45 at a single dose for COVID-19 immunization. Medical history included anxiety, asthma, seasonal allergies, known_allergies: PCN and dairy allergy. Concomitant medication included celecoxib (CELEXA, 40 mg) and cetirizine hydrochloride (ZYRTEC, 10 mg). On 30Dec2020, the patient experienced sore left arm for 24 hours. Additionally, she had ache body and headache for 12 hours. The events were assessed as non-serious, did not result in death, not life threatening, did not cause/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the adverse events. The vaccine was administered in a hospital. The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient had Nasal Swabs for COVID-19 on 05Jan2021 and 06Jan2021, both results were negative. The outcome of the events was recovered on an unspecified date in Dec2020.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Chest discomfort, Chills, Dyspnoea
Clinical narrative: pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of upper extremities/tingling; sore throat; shortness of breath; anxiety; malaise; This is a spontaneous report from a contactable Nurse (patient).  A 48-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: EL1284), via an unspecified route of administration in left arm on 04Jan2021 05:15 at single dose for COVID-19 immunization. Medical history included the patient was diagnosed with COVID-19 prior to vaccination. The patient had no Known allergies. Concomitant medication included zinc, vitamin d3, quercetin and sambucus nigra (ELDERBERRY) received within 2 weeks of vaccination. The patient reported that 12 hours after the injection she experienced severe headache, nausea, chills, temp 102, tingling of upper extremities, sore throat, shortness of breath, pressure in her chest on 04Jan2021 17:15. The fever/chills lasted about 12hrs. Chest discomfort, tingling and shortness of breath were transient (possibly anxiety related). Day 2 post vaccine in Jan2021 moderate to severe HA (headache) persisted and malaise. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The events were reported as non-serious. The patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Nausea, Oropharyngeal pain, Paraesthesia
Clinical narrative: pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of upper extremities/tingling; sore throat; shortness of breath; anxiety; malaise; This is a spontaneous report from a contactable Nurse (patient).  A 48-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: EL1284), via an unspecified route of administration in left arm on 04Jan2021 05:15 at single dose for COVID-19 immunization. Medical history included the patient was diagnosed with COVID-19 prior to vaccination. The patient had no Known allergies. Concomitant medication included zinc, vitamin d3, quercetin and sambucus nigra (ELDERBERRY) received within 2 weeks of vaccination. The patient reported that 12 hours after the injection she experienced severe headache, nausea, chills, temp 102, tingling of upper extremities, sore throat, shortness of breath, pressure in her chest on 04Jan2021 17:15. The fever/chills lasted about 12hrs. Chest discomfort, tingling and shortness of breath were transient (possibly anxiety related). Day 2 post vaccine in Jan2021 moderate to severe HA (headache) persisted and malaise. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The events were reported as non-serious. The patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: pressure in my chest/Chest discomfort; severe headache; nausea; chills; temp 102/fever; tingling of upper extremities/tingling; sore throat; shortness of breath; anxiety; malaise; This is a spontaneous report from a contactable Nurse (patient).  A 48-years-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: EL1284), via an unspecified route of administration in left arm on 04Jan2021 05:15 at single dose for COVID-19 immunization. Medical history included the patient was diagnosed with COVID-19 prior to vaccination. The patient had no Known allergies. Concomitant medication included zinc, vitamin d3, quercetin and sambucus nigra (ELDERBERRY) received within 2 weeks of vaccination. The patient reported that 12 hours after the injection she experienced severe headache, nausea, chills, temp 102, tingling of upper extremities, sore throat, shortness of breath, pressure in her chest on 04Jan2021 17:15. The fever/chills lasted about 12hrs. Chest discomfort, tingling and shortness of breath were transient (possibly anxiety related). Day 2 post vaccine in Jan2021 moderate to severe HA (headache) persisted and malaise. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment received for the events. The events were reported as non-serious. The patient was not pregnant at the time of vaccination. The most recent COVID-19 vaccine was administered in hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was recovering.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Heart rate, Heart rate increased, Hyperhidrosis
Clinical narrative: mouth sores; Nausea; vomiting; stomach cramps; sweats; joint pain; elevated heart rate; This is a spontaneous report from a contactable other HCP (Patient).  A 21-year-old female patient received her first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE) Lot #EL0140, via an unspecified route of administration on 29Dec2020 12:00 at single dose at Left arm for COVID-19 immunisation.  Medical history included Behcets, dysautonomia, Irritable bowel syndrome (IBS), and COVID-19.  The patient's concomitant medications included unspecified products within two weeks of vaccination.  The patient previously took amoxicillin, MELOXICAM (MOBIC) minocycline and all experienced drug hypersensitivity.  On 30Dec2020 12:00 the patient experienced mouth sores, nausea, vomiting, stomach cramps, sweats, joint pain and elevated heart rate. There was no other vaccine in four weeks. The patient was not pregnant. Prior to vaccination, the patient was diagnosed with COVID-19 and  since the vaccination, the patient has not been tested for COVID-19. The reporter considered all the events are non-serious and stated no treatment was received. The events outcome was not resolved.