chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Disorientation, Dizziness, Myalgia, Tremor
Clinical narrative: dizzy; disoriented; sore muscles; chills; shaking all over; This case was reported by a consumer and described the occurrence of dizziness in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 24th September 2020, 1 hr after receiving Shingrix, the patient experienced dizziness, disorientation, muscle soreness, chills and tremor. On an unknown date, the outcome of the dizziness, disorientation, muscle soreness, chills and tremor were recovered/resolved.   It was unknown if the reporter considered the dizziness, disorientation, muscle soreness, chills and tremor to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. One hour after receiving 1st dose of Shingrix, patient experienced chills, shaking all over, sore muscle, disoriented and dizziness. The reporter stated that the events were resolved. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR254620:same reporter
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Mild case of Shingles; This case was reported by a consumer and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 months after receiving Shingrix and an unknown time after starting acyclovir, the patient experienced shingles. The patient was treated with acyclovir. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of Shingrix and experienced shingles. The patient was treated with acyclovir. The reporter did not consen to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: New onset Afib; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced new onset Afib.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 14 Jan 2021, 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 the evening of 15 Jan 2021, the patient was hospitalized for new onset Afib. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, new onset Afib, was not reported.; Reporter's Comments: This spontaneous report refers to a case of female patient who experienced a serious event of new onset Afib on the same day after administration of the first dose of mRNA-127 (lot unknown, Exp date-unknown). Based on temporal the information provided and the absence of any other etiology factors, a causal association cannot be excluded
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Chills, Delirium, Ear discomfort
Clinical narrative: High pulse rate at rest - over a 100; I feel it in my right ear-Swishing sound; Couldn't sleep; Afraid to go to sleep, and afraid to not wake up; Felt delirious; High fever 100.5° - 101.1°; Chills; A spontaneous report was received from a 58-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) felt delirious and experienced high fever 100.5 - 101.1, chills, high pulse rate at rest - over a 100, I feel it in my right ear - swishing sound, couldn't sleep until 3 am, afraid to go to sleep, and afraid to not wake up.  The patient's medical history, as provided by the reporter, included menopause and high blood pressure. Concomitant product use included valsartan and bumetanide.   On 15 Jan 2021 between 7:15  7:30 AM, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 15 Jan 202 between 4:30 - 5 PM, the patient experienced symptoms of high fever 100.5 - 101.1 degrees Fahrenheit, chills, and felt delirious.  On 18 Jan 2021, the patient reported a high pulse rate at rest, in her right ear she felt a swishing sound. Additionally, the patient, could not sleep, she was afraid to go to sleep and afraid to not wake up. Treatment for the events included a cold compress and paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, high fever 100.5  101.1, was considered resolved. The outcome for the events, high pulse rate at rest - over a 100, in her right ear she felt  swishing sound, couldn't sleep, afraid to go to sleep, and afraid to not wake up was considered not resolved. The outcome for the events, chills and felt delirious, was unknown.; Reporter's Comments: This spontaneous report refers to a case of a male patient with medical history of high blood pressure, who experienced a serious event of felt delirious and non-serious events of high fever 100.5 - 101.1, chills, high pulse rate at rest - over a 100. "I feel it in my right ear"  swishing sound, couldn't sleep until 3 am, afraid to go to sleep, and afraid to not wake up. The events of fever, chills and delirium developed on the same day after the administration of the mRNA-1273 vaccine (lot # unknown, expiration date-unknown).  The other couldn't sleep, felt swishing sound in ear, afraid to go to sleep and afraid to not wake up and high pulse rate occurred 3 days after the vaccine administration. Treatment administered include cold compress and paracetamol. The events of fever and chills are listed in safety profile of the vaccine and based on the information provided which includes a temporal association, a causal association between the reported events and the administration of the vaccine cannot be excluded.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Insomnia, Pyrexia
Clinical narrative: High pulse rate at rest - over a 100; I feel it in my right ear-Swishing sound; Couldn't sleep; Afraid to go to sleep, and afraid to not wake up; Felt delirious; High fever 100.5° - 101.1°; Chills; A spontaneous report was received from a 58-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) felt delirious and experienced high fever 100.5 - 101.1, chills, high pulse rate at rest - over a 100, I feel it in my right ear - swishing sound, couldn't sleep until 3 am, afraid to go to sleep, and afraid to not wake up.  The patient's medical history, as provided by the reporter, included menopause and high blood pressure. Concomitant product use included valsartan and bumetanide.   On 15 Jan 2021 between 7:15  7:30 AM, the patient received her first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 15 Jan 202 between 4:30 - 5 PM, the patient experienced symptoms of high fever 100.5 - 101.1 degrees Fahrenheit, chills, and felt delirious.  On 18 Jan 2021, the patient reported a high pulse rate at rest, in her right ear she felt a swishing sound. Additionally, the patient, could not sleep, she was afraid to go to sleep and afraid to not wake up. Treatment for the events included a cold compress and paracetamol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, high fever 100.5  101.1, was considered resolved. The outcome for the events, high pulse rate at rest - over a 100, in her right ear she felt  swishing sound, couldn't sleep, afraid to go to sleep, and afraid to not wake up was considered not resolved. The outcome for the events, chills and felt delirious, was unknown.; Reporter's Comments: This spontaneous report refers to a case of a male patient with medical history of high blood pressure, who experienced a serious event of felt delirious and non-serious events of high fever 100.5 - 101.1, chills, high pulse rate at rest - over a 100. "I feel it in my right ear"  swishing sound, couldn't sleep until 3 am, afraid to go to sleep, and afraid to not wake up. The events of fever, chills and delirium developed on the same day after the administration of the mRNA-1273 vaccine (lot # unknown, expiration date-unknown).  The other couldn't sleep, felt swishing sound in ear, afraid to go to sleep and afraid to not wake up and high pulse rate occurred 3 days after the vaccine administration. Treatment administered include cold compress and paracetamol. The events of fever and chills are listed in safety profile of the vaccine and based on the information provided which includes a temporal association, a causal association between the reported events and the administration of the vaccine cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Facial paralysis
Clinical narrative: Facial paralysis; A spontaneous report was received from a pharmacist concerning a patient between 51 to 55 years of age, who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed facial paralysis.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 04 Jan 2021, approximately two days 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 06 Jan 2021, the patient began having symptoms of facial paralysis and the symptoms got progressively worse.  On 08 Jan 2021, the patient sought medical attention where they received an official diagnosis of facial paralysis. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, facial paralysis, was unknown.; Reporter's Comments: This case concerns a patient between 51 to 55 years of age of unknown gender. The medical history is not provided. The patient experienced a medically significant and unexpected event of Facial paralysis approximately two days after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Ultrasound Doppler
Clinical narrative: DVT blood clot; A spontaneous report was received from a 60-year-old male consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and developed deep vein thrombosis (DVT) blood clot.    The patient's medical history, as provided by the reporter, included factor V Leiden, enlarged prostate, DVT, pulmonary embolism and hypertension. Concomitant medications reported included valsartan, alfuzosin, and acetylsalicylic acid.   On 07 Jan 2021, approximately four days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.   On 11 Jan 2021, the patient developed DVT blood clot and experienced leg pain so intense that he could not walk. A doppler exam showed the DVT was from the top of the calf to mid-thigh. Treatment for the event included a rivaroxaban starter pack with dose tapering.   Action taken with mRNA-1273 in response to the event deep vein thrombosis (DVT) blood clot was not reported.  The outcome of the event, DVT blood clot, was unknown.; Reporter's Comments: This case concerns a 60-year-old male patient with a relevant medical history of factor V Leiden, DVT, pulmonary embolism and hypertension who received their first of two planned doses of mRNA-1273 (Lot number: 011J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. Patient experienced the medically significant unlisted event of Deep vein thrombosis approximately four days after administration of vaccine. Treatment for the event included rivaroxaban. Based on the temporal association between the use of the product and the event occurring after receiving the vaccine, a causal relationship cannot be excluded and the event of Deep vein thrombosis is possibly related to the product. Of note, the patient's underlying Factor V Leiden which predispose to developing abnormal blood clots, and prior medical history of DVT with pulmonary embolism are considered risk factors to the occurrence of the event.
Sex: F
Vaccine: COVID19
Symptoms: Cardiac arrest, Diarrhoea, Facial bones fracture, Feeling hot, Head discomfort
Clinical narrative: Passed out from cardiac arrest (her head feeling really full and really hot, and felt as if she was going to pass out, then she passed out).; Passed out; fractured her face; Head really hot; Head full; Diarrhea; heart rate dropped; platelets dropped; A spontaneous report was received from a consumer concerning a 75-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced head feeling really full and really hot, passed out from cardiac arrest, heart rate dropped, platelets dropped, fractured her face and diarrhea.  The patient's medical history was not provided. Concomitant medication included atenolol.   On 13 Jan 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: Unknown) in her arm for prophylaxis of COVID-19 infection.   On 15 Jan 2021, the patient complained her head was feeling full and hot. Felt as she was going to pass out, then she passed out from cardiac arrest and fractured her face. After passing out she got diarrhea.  On 15 Jan 2021, the patient was hospitalized. The patient's heart rate decreased to 22 beats/minute three times and to 15 beats/minutes twice, and her platelet count dropped.  The second dose of mRNA-1273 was discontinued in response to the events.  The outcome for the events, head feeling really full and really hot, passed out from cardiac arrest, heart rate dropped, platelets dropped, fractured her face and diarrhea, and diarrhea, was unknown.; Reporter's Comments: This spontaneous report concerning a 75-year-old, female subject who experienced unexpected events of passed out from cardiac arrest and fractured her face, head feeling really full and really hot, and felt as if she was going to pass out, then she passed out, and got diarrhea, heart rate dropped down to 22, platelets also dropped, after the first dose of the Vaccine (mRNA-1273) (Lot number: unknown, expiration date: unknown). The events developed 2 days after vaccine administration. The patient was hospitalized. Treatment and outcome are unknown.'  Based on the information which includes a temporal association and the absence of any other etiology, a causal association cannot be excluded. However, there is inadequate information in that the patient's medical history is lacking and event is also confounded by patient's advanced age.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate decreased, Loss of consciousness, Platelet count, Platelet count decreased
Clinical narrative: Passed out from cardiac arrest (her head feeling really full and really hot, and felt as if she was going to pass out, then she passed out).; Passed out; fractured her face; Head really hot; Head full; Diarrhea; heart rate dropped; platelets dropped; A spontaneous report was received from a consumer concerning a 75-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced head feeling really full and really hot, passed out from cardiac arrest, heart rate dropped, platelets dropped, fractured her face and diarrhea.  The patient's medical history was not provided. Concomitant medication included atenolol.   On 13 Jan 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot number: Unknown) in her arm for prophylaxis of COVID-19 infection.   On 15 Jan 2021, the patient complained her head was feeling full and hot. Felt as she was going to pass out, then she passed out from cardiac arrest and fractured her face. After passing out she got diarrhea.  On 15 Jan 2021, the patient was hospitalized. The patient's heart rate decreased to 22 beats/minute three times and to 15 beats/minutes twice, and her platelet count dropped.  The second dose of mRNA-1273 was discontinued in response to the events.  The outcome for the events, head feeling really full and really hot, passed out from cardiac arrest, heart rate dropped, platelets dropped, fractured her face and diarrhea, and diarrhea, was unknown.; Reporter's Comments: This spontaneous report concerning a 75-year-old, female subject who experienced unexpected events of passed out from cardiac arrest and fractured her face, head feeling really full and really hot, and felt as if she was going to pass out, then she passed out, and got diarrhea, heart rate dropped down to 22, platelets also dropped, after the first dose of the Vaccine (mRNA-1273) (Lot number: unknown, expiration date: unknown). The events developed 2 days after vaccine administration. The patient was hospitalized. Treatment and outcome are unknown.'  Based on the information which includes a temporal association and the absence of any other etiology, a causal association cannot be excluded. However, there is inadequate information in that the patient's medical history is lacking and event is also confounded by patient's advanced age.
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bell's palsy stage 4/partial face paralysis; A spontaneous report was received from a female consumer who received Moderna's COVID-19 vaccine and diagnosed with Bell's palsy stage 4.  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 intramuscularly for prophylaxis of COVID-19 infection.   On 25 Dec 2020, after receiving the vaccine the patient was diagnosed with stage 4 Bell's palsy. She has a partial face paralysis. Treatment for the event was not provided.   Action taken with the mRNA-1273 in response to the event was not reported.   The outcome for the event was Not recovered/Not resolved.; Reporter's Comments: This case concerns a female patient of unknown age. The medical history is not provided. The patient experienced a medically significant and unexpected event of Facial paralysis approximately two days after receiving their first of two planned doses of mRNA-1273 (Lot unknown). Very limited information regarding this event has been provided at this time. However, based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chills, Hot flush, Paraesthesia, Paraesthesia oral
Clinical narrative: Face feels like a dry mud mask on it; Tongue tingling; Inconsistent chills; Red hot flushed skin; Anaphylactic response; Pin pricks all over her body; A report was received from a consumer who was a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the serious adverse event of an anaphylactic reaction, body paresthesia, facial rigidity, tingling tongue, chills, and red, hot flushed skin.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 042L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Jan 2021 the patient reported that she received the Moderna vaccine . It took 35 minutes to have a systemic reaction of anaphylactic response which started with tightness in the throat, swelling tongue, itching, that became tighter and tighter along with body paresthesia. The paresthesia continued and felt like pin pricks all over her body except for her face which felt like it had a dry mud mask on it. She reported that she had no temperature but did have red, hot flushed skin. Her tongue was tingling and irritated, and she had inconsistent chills. The paresthesia and tingling tongue were "driving her nuts." Treatment for the event included diphenhydramine hydrochloride.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, anaphylactic reaction, body paresthesia, facial rigidity, tingling tongue, chills, and red, hot flushed skin, was unknown/not reported.; Reporter's Comments: Company Comment: This case concerns a patient who experienced unexpected serious systemic reaction of anaphylactic response and non-serious reactions of body paresthesia, facial rigidity, tingling tongue, chills, and red, hot flushed skin. The events occurred 35 minutes after the first dose and only dose of the vaccine mRNA-1273 vaccine (lot # 042L20A, expiration date-unknown).  Based on the information provided which includes a strong temporal association, for all reported events, a causal association cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Reduced facial expression
Clinical narrative: Face feels like a dry mud mask on it; Tongue tingling; Inconsistent chills; Red hot flushed skin; Anaphylactic response; Pin pricks all over her body; A report was received from a consumer who was a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced the serious adverse event of an anaphylactic reaction, body paresthesia, facial rigidity, tingling tongue, chills, and red, hot flushed skin.    The patient's medical history was not provided. No relevant concomitant medications were reported.   On 16 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number 042L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 16 Jan 2021 the patient reported that she received the Moderna vaccine . It took 35 minutes to have a systemic reaction of anaphylactic response which started with tightness in the throat, swelling tongue, itching, that became tighter and tighter along with body paresthesia. The paresthesia continued and felt like pin pricks all over her body except for her face which felt like it had a dry mud mask on it. She reported that she had no temperature but did have red, hot flushed skin. Her tongue was tingling and irritated, and she had inconsistent chills. The paresthesia and tingling tongue were "driving her nuts." Treatment for the event included diphenhydramine hydrochloride.    Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, anaphylactic reaction, body paresthesia, facial rigidity, tingling tongue, chills, and red, hot flushed skin, was unknown/not reported.; Reporter's Comments: Company Comment: This case concerns a patient who experienced unexpected serious systemic reaction of anaphylactic response and non-serious reactions of body paresthesia, facial rigidity, tingling tongue, chills, and red, hot flushed skin. The events occurred 35 minutes after the first dose and only dose of the vaccine mRNA-1273 vaccine (lot # 042L20A, expiration date-unknown).  Based on the information provided which includes a strong temporal association, for all reported events, a causal association cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: The vaccine was administered to the patient with a subq needle; A spontaneous report was received from a pharmacist concerning 65-year old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) administered with a 5/8-inch (subcutaneous) needle.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot#026L20A) for prophylaxis of COVID-19 infection.   On an unknown date, the patient was administered a vaccine using a 5/8-inch (subcutaneous) needle. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The event, vaccine administered with a 5/8-inch (subcutaneous) needle, was considered recovered/resolved.; Reporter's Comments: This report refers to a case of Product administration error (administered with a 5/8-inch needle) for mRNA-1273, lot # 026L20A.  There were no reported AEs associated with this case of Product administration error. The reported event is unlisted and company causality was assessed s not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Pyrexia
Clinical narrative: fever; vaccinated after the 6 hour mark; A spontaneous report was received from a hospital office manager concerning a patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a fever and was vaccinated after the 6 hour mark.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 06 Jan 2021, it was reported that the facility was delivered 3 vials of the vaccine, with no documentation, from the Department of Public Health. Some vaccines were left out more than 6 hours punctured but were refrigerated. The vaccines were used to vaccinate staff and patients, approximately 20 people. Of the 20 people vaccinated at least 10 were vaccinated after the 6 hours mark.  On 06 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection and received vaccine that from a vial that had been punctured more than 6 hours previously.  On an undisclosed date, the patient also experienced a fever after receiving the vaccine.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the event, fever, was not reported. The outcome of the event, was vaccinated after the 6 hour mark, was considered resolved on 06 Jan 2021.; Reporter's Comments: This report refers to a case of product administration error for mRNA, where the vaccine was administered from a vial punctured more than 6 hours. The event of pyrexia was associated with this case of out of specification product use.
Sex: F
Vaccine: COVID19
Symptoms: Blindness unilateral, Retinal artery occlusion, Thrombosis
Clinical narrative: blindness in left eye; stroke in back of the eye; blood clot; A spontaneous report was received from a consumer concerning an 83-year-old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced blindness in left eye, blood clot, and stroke in back of the eye.  The patient's medical history was not provided. Concomitant medications reported included comerdol, losartan, hydrocortisone, meloxicam, and unspecified stomach pills.  On 14 Jan 2021 at 10:15 am, approximately 3 hours and 45 minutes prior to the onset of the events, the patient received a dose of mRNA-1273 (Lot number: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 14 Jan 2021 around 2:00 pm, the patient lost sight in her left eye as a result of a blood clot and stroke in the back of her eye. No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, blindness in left eye, blood clot, and stroke in back of eye, was unknown.; Reporter's Comments: This case concerns an 83-years-old female patient, who experienced a serious unexpected event of blindness unilateral, retinal artery occlusion, and thrombosis. The event of blindness unilateral and retinal artery occlusion occurred 3 hrs. after first dose of mRNA-1273, lot # 013L20A.  The event of thrombosis occurred on an unspecified date after first dose of mRNA-1273, lot # 013L20A. Treatment included details were not provided. Concomitant medications included Comerdol, Losartan for blood pressure, Hydrocortisone, Meloxicam and stomach pills. Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and onset of the event a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: Needle slipped and some of the content was lost on her arm; needle slipped and some of the content was lost on her arm; A spontaneous report was received from a nurse concerning a female patient who received Moderna's COVID-19 vaccine and received less than a full dose due to the needle slipping and some of the content was lost on the patient's arm.  The patient's medical history was not included. Products known to have been used by the patient, were not provided.  On 26 Jan 2021, prior to the onset of the events, the patient received one of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection.    On 26 Jan 2021, after she received the mRNA-1273 vaccination, the nurse notes that the patient did not receive the full dose as the needle slipped and some of the content was lost on her arm. Treatment information was not provided.   Action taken with the second dose of mRNA-1273 in response to the event was not reported.    The outcome of the event, not receiving a full dose due to the needle slipping and some of the content was lost on her arm, was considered resolved.; Reporter's Comments: This case concerns a female patient of unknown age who received one of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection and after she received the vaccination, the nurse notes that the patient did not receive the full dose as the needle slipped and some of the content was lost on her arm. There were no reported adverse events associated with this case of device connection issue and incorrect dose administered
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure via skin contact, Incorrect dose administered
Clinical narrative: Vaccine dripping down her arm; Vaccine dripping down her arm; A spontaneous report was received from a consumer who was a 22-year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccine dripping down her arm.   The patient's medical history was not reported. Concomitant product use reported included unspecified birth control.   On 15 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013Z20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 15 Jan 2021, the patient experienced vaccine dripping down her arm during vaccine administration. The nurse administering the vaccine did not have the needle pushed in all the way into the patient's arm.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The event, vaccine dripping down arm, was considered resolved on 15 Jan 2021.; Reporter's Comments: This report refers to a case of incorrect dose administered and exposure through skin contact for COVID-19 vaccine mRNA-1273, lot # 013Z20A. There were no reported AEs associated with this case of incorrect dose administered and exposure through skin contact .
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Loss of hearing in his right ear; A spontaneous report was received from a 73-year-old, male, patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced hearing loss in right ear.    The patient's medical history, as provided by the reporter, included ventriculoperitoneal (VP) shunt in his head. Concomitant product use was not provided by the reporter.   On 12 Jan 2021, approximately two days 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 14 Jan 2021, the patient had dental work done where four crowns were prepped and temporaries were put in, he then lost hearing in his right ear. Treatment information was not provided. He thinks that the loss of hearing might be due to this dental procedure as they were drilling for hours. He states that he has a VP shunt in this head which needs readjustments occasionally. He is seeing his neurosurgeon for the readjustment.  Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event, hearing loss in right ear, was unknown.; Reporter's Comments: This case concerns a 73 year-old, male patient with history of ventriculoperitoneal (VP) shunt in his head, who experienced event of hearing loss in right ear. The event occurred 2 days after the first and last dose of mRNA-1273 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 and the event is assessed as possibly related.  However, on the same day and prior to the onset of the event, the patient had extensive dental procedures done which may provide an alternative explanation for the event.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Injection site erythema, Injection site streaking, Injection site swelling
Clinical narrative: injection site swelling (size of dime); TThe one at the injection site itself, was an injection site swelling about the size of a dime, "a red area"/at the site where the shot was administered he has some red streaks; red streaks running from the site up to his neck and shoulder. It is very small. It looks like if he took a ball point pin and drew some lines; This is a spontaneous report from the Medical Information Team. A contactable consumer reported that a 72-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: ELO142, via an unspecified route of administration from 13Jan2021 11:00 at SINGLE DOSE for COVID-19 immunization. Medical history included haemochromatosis diagnosed in the mid 90's and wa reported as hereditary it was too much iron in the blood, he goes once a month for therapeutic phlebotomy to reduce the iron in the blood; very rare bacterial infection called Arupense from an unknown; he has a slight case of asthma but mentioned that it was related to living on the coast with the mold and moisture and also has a little wheezing. Concomitant medications included ethambutol, montelukast, pravastatin, amlodipine; hydrochlorothiazide, lisinopril; colecalciferol (VITAMIN D), acetylsalicylic acid (ASPIRIN (E.C.) and rifampin for infection and blood pressure medications.  Patient had the first dose of the vaccine yesterday 13Jan2021. He has no discomfort, but at the site where the shot was administered, he has some red streaks running from the site up to his neck and shoulder. It was very small. It looks like if he took a ball point pin and drew some lines. However, the patient's wife said it was bigger than a ball point pen. It was jagged lines. The one at the injection site itself, the injection site swelling was about the size of a dime, a red area. He only discovered the red streaks about an hour ago on 14Jan2021, so there has not been no radical change. Patient has concerns; he wanted to know if he should seek medical advice. "Is it just a rash?", he asked. His doctor doesn't know about this yet.   No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Exposure to SARS-CoV-2, Fatigue, Pyrexia
Clinical narrative: been in contact with someone who is Covid-19 positive; Chest tightness; Low grade fever; Vomiting; Cough; has been sick since getting the vaccine; tired and fatigue; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 11Jan2021 at a single dose for front line worker (covid-19 immunization). Medical history included ongoing HIV since 2015. There were no concomitant medications. The patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for front line worker (covid-19 immunization). The patient reported that he received his second dose of the Pfizer-BioNTech Covid-19 Vaccine last Monday (11Jan2021) between 8:00 am and 8:30 am, and since then he has been sick and has been experiencing some side effects. He mentioned that he has been in contact with someone who is Covid-19 positive on an unspecified date. He works at the front desk registration in a hospital. He has been tired and fatigued, has had a low-grade fever, vomiting, headache, cough and chest tightness. He added that on Monday evening (11Jan2021), he became tired and fatigued. He had an on and off fever on Tuesday (12Jan2021). He started vomiting while coughing on 12Jan2021. He went to the doctor last night (13Jan2021) and he said he got tested for Covid-19 on 13Jan2021, but the results came out negative. The physician said that it would. However, his physician said that it was too early to tell if he has been infected since he has just been exposed last Monday. Normally, they like to have a 5 day turn around for a true reading. He said his physician told him he just needed to quarantine. He mentioned that his chest feels tight when he coughs on 13Jan2021. When he had to take deep breaths while the doctor was listening to him breath his chest was tight. He had blood work drawn at the doctor's office, but he does not have any results to provide. The patient wanted to know what he needs to do about this. He was inquiring if there any recommendations. He is probably negative because he is symptomatic. His employer said it may be a reaction from the shot. The outcome of the events sickness and exposure to COVID-19 were unknown, as for the event vomiting was recovered on 12Jan2021 while the outcome of the other events was not recovered.    The following information on the batch/lot number has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Vomiting
Clinical narrative: been in contact with someone who is Covid-19 positive; Chest tightness; Low grade fever; Vomiting; Cough; has been sick since getting the vaccine; tired and fatigue; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received his second dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration left arm on 11Jan2021 at a single dose for front line worker (covid-19 immunization). Medical history included ongoing HIV since 2015. There were no concomitant medications. The patient received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for front line worker (covid-19 immunization). The patient reported that he received his second dose of the Pfizer-BioNTech Covid-19 Vaccine last Monday (11Jan2021) between 8:00 am and 8:30 am, and since then he has been sick and has been experiencing some side effects. He mentioned that he has been in contact with someone who is Covid-19 positive on an unspecified date. He works at the front desk registration in a hospital. He has been tired and fatigued, has had a low-grade fever, vomiting, headache, cough and chest tightness. He added that on Monday evening (11Jan2021), he became tired and fatigued. He had an on and off fever on Tuesday (12Jan2021). He started vomiting while coughing on 12Jan2021. He went to the doctor last night (13Jan2021) and he said he got tested for Covid-19 on 13Jan2021, but the results came out negative. The physician said that it would. However, his physician said that it was too early to tell if he has been infected since he has just been exposed last Monday. Normally, they like to have a 5 day turn around for a true reading. He said his physician told him he just needed to quarantine. He mentioned that his chest feels tight when he coughs on 13Jan2021. When he had to take deep breaths while the doctor was listening to him breath his chest was tight. He had blood work drawn at the doctor's office, but he does not have any results to provide. The patient wanted to know what he needs to do about this. He was inquiring if there any recommendations. He is probably negative because he is symptomatic. His employer said it may be a reaction from the shot. The outcome of the events sickness and exposure to COVID-19 were unknown, as for the event vomiting was recovered on 12Jan2021 while the outcome of the other events was not recovered.    The following information on the batch/lot number has been requested.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Painful Lymphadenopathy in the vaccinated arm and same side of the neck; This is a spontaneous report from a contactable physician (patient). A 37-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL3246) intramuscular in the left arm on 12Jan2021 07:15 AM at a single dose as Covid vaccine. The patient had no medical history. She has no known allergies. Concomitant medications were not reported. The patient had her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EJ1685) intramuscular in the left arm on 22Dec2020 12:45 AM as Covid vaccine. She had no other vaccine in four weeks. She experienced painful lymphadenopathy in the vaccinated arm and same side of the neck that started 24hrs post vaccine on 13Jan2021 07:15 AM. Treatment was not received for the event. She has no Covid prior to vaccination. She did not have Covid tested post vaccination. The outcome of the event was recovering.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: I had a bowel movement and lots of blood; This is a spontaneous report from a contactable consumer (patient). A 49-year-old female patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJI686), via an unspecified route of administration in the right arm on 11Jan2021 at 12:45 as a single dose for COVID-19 immunization. Medical history included arthritis and migraines. The patient had no other vaccines within four weeks and did not have COVID prior to the vaccination. Concomitant medications (reported as other medications in two weeks) included fexofenadine hydrochloride (ALLEGRA) and paracetamol (TYLENOL). On 13Jan2021 at 12:00 AM, the patient had a bowel movement and lots of blood and also on 15Jan2021, she had a bowel movement with blood. The patient was not treated for the event. The patient had not tested positive for COVID post vaccination. Outcome of the event was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Acute asthma attack; This is a spontaneous report from a contactable pharmacist. A 46-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK9231), intramuscular in the left arm on 15Jan2021 07:45 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced acute asthma attack on 15Jan2021 08:00. This adverse event resulted in emergency room/department or urgent care. Therapeutic measures were taken as a result of acute asthma attack and included treatment with albuterol inhaler. Outcome of the event was recovering.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test negative, SARS-CoV-2 test positive
Clinical narrative: tested positive for covid on 12Jan, is asymptomatic, and tested negative after two days; tested positive for covid on 12Jan, is asymptomatic, and tested negative after two days; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 30Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient received the first dose of the COVID vaccine on 30Dec2020 and was supposed to take the next dose on 20Jan2021. However he tested positive for COVID on 12Jan2021 and was asymptomatic, and tested negative after two days on 14Jan2021. He wanted to know if he can take the second dose even if he tested positive. The outcome of the event was recovered on 14Jan2021.   Information on the lot/ batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: I received the first dose of the Pfizer vaccine on 30Dec2020 and got covid on 04Jan2021 via positive nasal swab test; I received the first dose of the Pfizer vaccine on 30Dec2020 and got covid on 04Jan2021 via positive nasal swab test; This is a spontaneous report from a from a Pfizer-sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age received first dose of BNT162B2 (Lot number and Expiration date not provided), via an unspecified route of administration on 30Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications was not reported. The patient had her first dose of COVID vaccine on 30Dec2020. She had a positive COVID test via Nasal swab test on 04Jan2021. She will be off of quarantine on 18Jan2021. For some reason her second dose of COVID Vaccine is not scheduled until 29Jan2021. She asked if she is COVID positive when should she get that next dose; and also the second dose scheduled her out 30 days which is a long time which she was questioning that as well. The outcome of the events was unknown.  Information on Lot/Batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Respiration abnormal, Skin tightness
Clinical narrative: Not feeling great; Slight headache; Breathing is heavier; Below her breast line is a tightness she can't really describe; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: SL3246), via an unspecified route of administration in right arm, on 12Jan2021 at 10:45, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient previously took varicella zoster vaccine (SHINGLES VACCINE) for immunization and had a little reaction but just the normal things. On Tuesday morning, the patient got the COVID-19 shot and was fine. This morning (15Jan2021), the patient was not feeling great, has a slight headache, her breathing is heavier, and below her breast line is a tightness she can't really describe. The patient asked if these were a side effect of the COVID-19 vaccine and wondering if this is normal. As a treatment for the events, the patient took paracetamol (TYLENOL). The patient asked if she can or should get a test, a COVID-19 test. It has been so many days since having the vaccine, 4 days later, she is wondering if she might have COVID-19. The patient isn't sure and is just asking a question. It is confirmed that she has not had a test or tested positive for COVID-19. The outcome of "Not feeling great" was unknown. The patient had not recovered from the remaining events.