chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Chills, Computerised tomogram, Decreased appetite, Deep vein thrombosis, Fatigue
Clinical narrative: July 23 Received vaccine 400 pm July 30 symptoms  started 600 am with uncontrollable shaking low grade fever 99.2, lower back pain, vomiting, severe headache. Blood pressure increased to 170/100  Continued thru the weekend - extreme abdominal pain, a feeling of impending death he said. Saturday, July 31 set up with teledoc appointment. Sunday 8am went to get Covid test at clinic in town.  Monday remained in extreme pain severe headache. Increased blood pressure. Tuesday had labs drawn(these were already scheduled) and they came back with platelets extremely low .   He  went to have rapid Covid test and antibody test. These came back negative. Continued with  with symptoms  they the week that was progressively getting worse. On Monday, aug 9 went back to  have labs drawn. Labs had improved slightly and thought he would try to work. Around 10am severe abdominal pain and came to ER. Labs, ct scans etc was done which showed bilateral multiple blood clots in the lungs, right leg and ischemic mesentery of the small loop bowel..  being followed by hematologist, surgery, GI and pcp. All tests have confirmed it is TTS -thrombosis with thrombocytopenia syndrome which is related to the j and j vaccine. He was in ICU from Aug 9 - Aug 13. Still in hospital on blood thinners, Oxygen, just now on liquids. And we don?t know what tomorrow brings
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Haemorrhage, Headache, Intestinal ischaemia, Lethargy, Magnetic resonance imaging
Clinical narrative: July 23 Received vaccine 400 pm July 30 symptoms  started 600 am with uncontrollable shaking low grade fever 99.2, lower back pain, vomiting, severe headache. Blood pressure increased to 170/100  Continued thru the weekend - extreme abdominal pain, a feeling of impending death he said. Saturday, July 31 set up with teledoc appointment. Sunday 8am went to get Covid test at clinic in town.  Monday remained in extreme pain severe headache. Increased blood pressure. Tuesday had labs drawn(these were already scheduled) and they came back with platelets extremely low .   He  went to have rapid Covid test and antibody test. These came back negative. Continued with  with symptoms  they the week that was progressively getting worse. On Monday, aug 9 went back to  have labs drawn. Labs had improved slightly and thought he would try to work. Around 10am severe abdominal pain and came to ER. Labs, ct scans etc was done which showed bilateral multiple blood clots in the lungs, right leg and ischemic mesentery of the small loop bowel..  being followed by hematologist, surgery, GI and pcp. All tests have confirmed it is TTS -thrombosis with thrombocytopenia syndrome which is related to the j and j vaccine. He was in ICU from Aug 9 - Aug 13. Still in hospital on blood thinners, Oxygen, just now on liquids. And we don?t know what tomorrow brings
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Malaise, Mesenteric vein thrombosis, Platelet count, Platelet count decreased, Portal vein thrombosis
Clinical narrative: July 23 Received vaccine 400 pm July 30 symptoms  started 600 am with uncontrollable shaking low grade fever 99.2, lower back pain, vomiting, severe headache. Blood pressure increased to 170/100  Continued thru the weekend - extreme abdominal pain, a feeling of impending death he said. Saturday, July 31 set up with teledoc appointment. Sunday 8am went to get Covid test at clinic in town.  Monday remained in extreme pain severe headache. Increased blood pressure. Tuesday had labs drawn(these were already scheduled) and they came back with platelets extremely low .   He  went to have rapid Covid test and antibody test. These came back negative. Continued with  with symptoms  they the week that was progressively getting worse. On Monday, aug 9 went back to  have labs drawn. Labs had improved slightly and thought he would try to work. Around 10am severe abdominal pain and came to ER. Labs, ct scans etc was done which showed bilateral multiple blood clots in the lungs, right leg and ischemic mesentery of the small loop bowel..  being followed by hematologist, surgery, GI and pcp. All tests have confirmed it is TTS -thrombosis with thrombocytopenia syndrome which is related to the j and j vaccine. He was in ICU from Aug 9 - Aug 13. Still in hospital on blood thinners, Oxygen, just now on liquids. And we don?t know what tomorrow brings
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Post thrombotic syndrome, Pulmonary embolism, Pyrexia, SARS-CoV-2 test, Splenic vein thrombosis
Clinical narrative: July 23 Received vaccine 400 pm July 30 symptoms  started 600 am with uncontrollable shaking low grade fever 99.2, lower back pain, vomiting, severe headache. Blood pressure increased to 170/100  Continued thru the weekend - extreme abdominal pain, a feeling of impending death he said. Saturday, July 31 set up with teledoc appointment. Sunday 8am went to get Covid test at clinic in town.  Monday remained in extreme pain severe headache. Increased blood pressure. Tuesday had labs drawn(these were already scheduled) and they came back with platelets extremely low .   He  went to have rapid Covid test and antibody test. These came back negative. Continued with  with symptoms  they the week that was progressively getting worse. On Monday, aug 9 went back to  have labs drawn. Labs had improved slightly and thought he would try to work. Around 10am severe abdominal pain and came to ER. Labs, ct scans etc was done which showed bilateral multiple blood clots in the lungs, right leg and ischemic mesentery of the small loop bowel..  being followed by hematologist, surgery, GI and pcp. All tests have confirmed it is TTS -thrombosis with thrombocytopenia syndrome which is related to the j and j vaccine. He was in ICU from Aug 9 - Aug 13. Still in hospital on blood thinners, Oxygen, just now on liquids. And we don?t know what tomorrow brings
Age: 54.0
Sex: M
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Ultrasound scan, Vomiting, Weight decreased, X-ray
Clinical narrative: July 23 Received vaccine 400 pm July 30 symptoms  started 600 am with uncontrollable shaking low grade fever 99.2, lower back pain, vomiting, severe headache. Blood pressure increased to 170/100  Continued thru the weekend - extreme abdominal pain, a feeling of impending death he said. Saturday, July 31 set up with teledoc appointment. Sunday 8am went to get Covid test at clinic in town.  Monday remained in extreme pain severe headache. Increased blood pressure. Tuesday had labs drawn(these were already scheduled) and they came back with platelets extremely low .   He  went to have rapid Covid test and antibody test. These came back negative. Continued with  with symptoms  they the week that was progressively getting worse. On Monday, aug 9 went back to  have labs drawn. Labs had improved slightly and thought he would try to work. Around 10am severe abdominal pain and came to ER. Labs, ct scans etc was done which showed bilateral multiple blood clots in the lungs, right leg and ischemic mesentery of the small loop bowel..  being followed by hematologist, surgery, GI and pcp. All tests have confirmed it is TTS -thrombosis with thrombocytopenia syndrome which is related to the j and j vaccine. He was in ICU from Aug 9 - Aug 13. Still in hospital on blood thinners, Oxygen, just now on liquids. And we don?t know what tomorrow brings
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: pt did not report adverse event. just wanted to report pt got Janssen prior to getting Moderna vaccine
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, Interchange of vaccine products
Clinical narrative: pt did not report adverse event. just wanted to report pt got Janssen prior to getting Moderna vaccine
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Aphasia, Balance disorder, Blood test normal, Computerised tomogram head normal, Disturbance in attention
Clinical narrative: fAfter recieving the first dose of the vaccination I was experiencing sweating and excessive hydration requirements.  It was the second does that I experienced more symptoms with.  After recieving my second dose of the vaccine I was experiencing ringing of my ears, dizziness, light headness, unbalanced, confused, dry eyes, slurred speech, head aces, short term memory loss, loss in apetite, poor concentration, blurry vision, achey body.   I am still currently experiencing all of these symptoms.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dry eye, Hyperhidrosis, Tinnitus
Clinical narrative: fAfter recieving the first dose of the vaccination I was experiencing sweating and excessive hydration requirements.  It was the second does that I experienced more symptoms with.  After recieving my second dose of the vaccine I was experiencing ringing of my ears, dizziness, light headness, unbalanced, confused, dry eyes, slurred speech, head aces, short term memory loss, loss in apetite, poor concentration, blurry vision, achey body.   I am still currently experiencing all of these symptoms.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Amnesia, Balance disorder, Blood test, Confusional state, Decreased appetite
Clinical narrative: fAfter recieving the first dose of the vaccination I was experiencing sweating and excessive hydration requirements.  It was the second does that I experienced more symptoms with.  After recieving my second dose of the vaccine I was experiencing ringing of my ears, dizziness, light headness, unbalanced, confused, dry eyes, slurred speech, head aces, short term memory loss, loss in apetite, poor concentration, blurry vision, achey body.   I am still currently experiencing all of these symptoms.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Disturbance in attention, Dizziness, Dry eye, Dysarthria, Headache
Clinical narrative: fAfter recieving the first dose of the vaccination I was experiencing sweating and excessive hydration requirements.  It was the second does that I experienced more symptoms with.  After recieving my second dose of the vaccine I was experiencing ringing of my ears, dizziness, light headness, unbalanced, confused, dry eyes, slurred speech, head aces, short term memory loss, loss in apetite, poor concentration, blurry vision, achey body.   I am still currently experiencing all of these symptoms.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Scan, Tinnitus, Vertigo, Vision blurred
Clinical narrative: fAfter recieving the first dose of the vaccination I was experiencing sweating and excessive hydration requirements.  It was the second does that I experienced more symptoms with.  After recieving my second dose of the vaccine I was experiencing ringing of my ears, dizziness, light headness, unbalanced, confused, dry eyes, slurred speech, head aces, short term memory loss, loss in apetite, poor concentration, blurry vision, achey body.   I am still currently experiencing all of these symptoms.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test normal, Chest X-ray normal, Chest pain, Dizziness, Dyspnoea
Clinical narrative: Patient reports numbness in her arm from elbow to hand for 2 days. She started experiencing such symptoms within the 15 minute observation period, but they did not go away. She also experienced dizziness, light headedness, and chest pain for 2 days after vaccination. In addition, she fainted 3 days after vaccinations and had to go to the hospital.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Electrocardiogram normal, Fibrin D dimer normal, Hypoaesthesia, Loss of consciousness, Paraesthesia
Clinical narrative: Patient reports numbness in her arm from elbow to hand for 2 days. She started experiencing such symptoms within the 15 minute observation period, but they did not go away. She also experienced dizziness, light headedness, and chest pain for 2 days after vaccination. In addition, she fainted 3 days after vaccinations and had to go to the hospital.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling
Clinical narrative: Patient reports numbness in her arm from elbow to hand for 2 days. She started experiencing such symptoms within the 15 minute observation period, but they did not go away. She also experienced dizziness, light headedness, and chest pain for 2 days after vaccination. In addition, she fainted 3 days after vaccinations and had to go to the hospital.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Angina pectoris, Blood test normal, Chest pain, Chills, Dizziness
Clinical narrative: Patient reports numbness in her arm from elbow to hand for 2 days. She started experiencing such symptoms within the 15 minute observation period, but they did not go away. She also experienced dizziness, light headedness, and chest pain for 2 days after vaccination. In addition, she fainted 3 days after vaccinations and had to go to the hospital.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Fear, Headache, Hypoaesthesia
Clinical narrative: Patient reports numbness in her arm from elbow to hand for 2 days. She started experiencing such symptoms within the 15 minute observation period, but they did not go away. She also experienced dizziness, light headedness, and chest pain for 2 days after vaccination. In addition, she fainted 3 days after vaccinations and had to go to the hospital.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Influenza like illness, Loss of consciousness, Malaise, Muscle spasms, Oesophageal spasm
Clinical narrative: Patient reports numbness in her arm from elbow to hand for 2 days. She started experiencing such symptoms within the 15 minute observation period, but they did not go away. She also experienced dizziness, light headedness, and chest pain for 2 days after vaccination. In addition, she fainted 3 days after vaccinations and had to go to the hospital.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, Pain in extremity, Paraesthesia, Presyncope, Pyrexia
Clinical narrative: Patient reports numbness in her arm from elbow to hand for 2 days. She started experiencing such symptoms within the 15 minute observation period, but they did not go away. She also experienced dizziness, light headedness, and chest pain for 2 days after vaccination. In addition, she fainted 3 days after vaccinations and had to go to the hospital.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: X-ray normal
Clinical narrative: Patient reports numbness in her arm from elbow to hand for 2 days. She started experiencing such symptoms within the 15 minute observation period, but they did not go away. She also experienced dizziness, light headedness, and chest pain for 2 days after vaccination. In addition, she fainted 3 days after vaccinations and had to go to the hospital.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dizziness, Hypoaesthesia, Syncope
Clinical narrative: Patient reports numbness in her arm from elbow to hand for 2 days. She started experiencing such symptoms within the 15 minute observation period, but they did not go away. She also experienced dizziness, light headedness, and chest pain for 2 days after vaccination. In addition, she fainted 3 days after vaccinations and had to go to the hospital.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash erythematous, Rash macular, Rash pruritic
Clinical narrative: Rash on his back and is slighlty pruritic; rash went from appearing as a four by four red blotch; Ten or twelve smaller red spots; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC, RASH MACULAR, and RASH ERYTHEMATOUS in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A. and 039K20A) for COVID-19 vaccination.     Concurrent medical conditions Grass allergy, Dust allergy, Hypertension, Hypercholesteraemia, and Cancer. Concomitant products included LOSARTAN, AMLODIPINE, and ZEBETA for Blood pressure high, CRESTOR for High cholesterol.   On 16-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2021 at 9:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Mar-2021, the patient experienced RASH PRURITIC. 06-Mar-2021, the patient experienced RASH MACULAR and RASH ERYTHEMATOUS. The patient was treated with TRIAMCINOLONE ACETONIDE for Rash, at a dose of 0.1%; PEPCID for Adverse event, at an unspecified dose and frequency and BENADRYL for Adverse event, at an unspecified dose and frequency. On 10-Apr-2021, RASH PRURITIC, RASH MACULAR, and RASH ERYTHEMATOUS had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   At the annual physical appointment on 18Mar2021, he received the second dose of the Shingrix vaccine series and  treated the rash with Pepcid during the day and Benadryl at night and also Triamcinolone cream. Serious patch of rash 4x4 inch on left shoulder blade, much pain, was treated with Triamcinolone Acetonide 0.1% for two weeks before rash started to wane, remnants remains for another month.   Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to US-MODERNATX, INC MOD-2021-069973, US-MODERNATX, INC MOD-2021-069767, MOD21-071085.   Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: Added patient demographics such as height, weight, race and ethnicity were updated. Other relevant history was added. Second dose date was changed and event onset date was changed as well. Event outcome was updated to recovered. Concomitant medications were updated. Treatment information was added. On 28-May-2021: Follow-up received on 28 May 2021 included no new information. On 16-Jul-2021: Updated reporter details and event details were provided.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling abnormal, Nausea, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp (patient). A 30-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EW0196), via an unspecified route of administration on an unspecified date (at the age of 30-year-old) as dose 1, single; dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot Number: FA74842) as dose 2, single, both doses for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced chills, fever, nausea, vomiting/feels like throwing up, feeling very bad, all on an unspecified date. Patient is a consumer. Patient had both doses of the Pfizer COVID 19 vaccine. Patient wants to know how long these symptoms will last and should she go to the emergency room. Patient went to the bathroom because she experienced nausea and vomiting. The patient was experiencing chills, fever, nausea, and vomiting. Patient says she was told if her symptoms of vaccine last more than 24 hours to call. Patient says she has had her second dose of Pfizer COVID-19 vaccine. Patient provides LOT for first dose EW0196 from her vaccine card, and second dose LOT FA74842, unable to clarify further. Patient says she may have to leave suddenly as she is feeling very bad and feels like throwing up. When call is joined unknown gentleman says patient has nausea right now, and chills, and fever and she wants to know is there something she can do to avoid it. Outcome of the events was unknown.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE's; Temperature excursion / temperature 6.134 F; This spontaneous report was received from licensed vocational nurse and refers to a 12 months old patient of unknown gender. There was no information regarding their medical history, concurrent conditions nor concomitant therapies provided.  On 08-AUG-2021, a dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) dose/frequency reported as 1 (units not provided), lot # T029535, expiration date 01-SEP-2022 was stored improperly in a temperature of 6.134 degree Fahrenheit (F) for 30 minutes and on 09-AUG-2021 (described also as this morning), it was administered to the patient (exact dose, route of administration and anatomical location were not provided) for prophylaxis. No previous temperature excursion was reported. The patient was asymptomatic and no adverse event was reported.  This is one of two reports from the same reporter.; Sender's Comments:  US-009507513-2108USA002735:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE reported.; expired dose of VAQTA was administered to a patient; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 06-AUG-2021, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) lot # T018670, expiration date 11-JUL-2021 (dose, route of administration and anatomical location were not reported) for prophylaxis. No additional adverse event was reported.
Age: 0.17
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: The patient not experienced any adverse event associated with the vaccination / No additional AE reported.; 2 month old patient was administered Varivax accidently.; This spontaneous report was received from a nurse and refers to a 2-month-old patient of an unknown gender. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided.  On 09-AUG-2021, the 2-month-old patient was accidently vaccinated with varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml, lot # T035401 was confirmed to be valid, expiration date 16-OCT-2022, (route and site of administration were not reported) for prophylaxis (Inappropriate age at vaccine administration). The patient did not experience any adverse event associated with the vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blood clots in both her legs.; This is a spontaneous report from a contactable consumer (patient's daughter-in-law) based on information received by Pfizer from agency (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-075012), license party for apixaban (ELIQUIS).   A 91-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), on an unspecified date (lot number and expiry date: unknown) as dose number unknown, single for Covid-19 immunisation; and apixaban (ELIQUIS), oral from an unspecified date (Lot Number: 1795397; Expiration Date: Aug2023) to an unspecified date, at 2.5 mg, 2x/day (BID), then oral from an unspecified date (lot number and expiry date: unknown) to an unspecified date, at 5 mg, 2x/day (BID) for deep vein thrombosis (DVT)/ blood clots. The patient's medical history and concomitant medications were not reported. Patient was on Eliquis for blood clots. The patient received the COVID vaccine and within few weeks, she developed blood clots in both her legs. The reporter did not provide causality assessment. The clinical outcome of the event was unknown. Action taken with apixaban was dose increased.  No follow-up attempts are possible. Information on lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: BMS medical evaluation comment: This 91-year-old patient had leg thrombosis after receiving apixaban therapy and COVID vaccine. Elderly age and underlying thrombotic risk are significant contributory factors for leg thrombosis in this patient and hence it is considered not related to apixaban. Additionally, COVID vaccine could be a confounding factor for the reported event.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Maternal exposure during breast feeding, Pyrexia
Clinical narrative: Diarrhoea; Chills; Pyrexia; Exposure during breastfeeding; This case was received  (Reference number: 0936865) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE DURING BREASTFEEDING (Exposure during breastfeeding), DIARRHOEA (Diarrhoea), CHILLS (Chills) and PYREXIA (Pyrexia) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Peanut allergy, Allergy to nuts (Allergic to pecan), Allergy to nuts (Allergic to nuts) and Stomach flu. Concomitant products included SERTRALINE for an unknown indication.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING BREASTFEEDING (Exposure during breastfeeding). On 09-Jan-2021, the patient experienced DIARRHOEA (Diarrhoea), CHILLS (Chills) and PYREXIA (Pyrexia). At the time of the report, MATERNAL EXPOSURE DURING BREASTFEEDING (Exposure during breastfeeding) outcome was unknown and DIARRHOEA (Diarrhoea), CHILLS (Chills) and PYREXIA (Pyrexia) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient reported that she experienced symptoms of chills, pyrexia, diarrhea and exposure during breastfeeding.  No treatment information was provided.   This case was linked to MOD-2021-249287 (Parent-Child Link).   See case MOD-2021-249287 for details regarding the child case.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: unevaluable event; This case was received via United States FDA VAERS (Reference number: 0937243) on 06-Apr-2021 and was forwarded to Moderna on 06-Apr-2021.    This spontaneous case was reported by an other health care professional and describes the occurrence of UNEVALUABLE EVENT (unevaluable event) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (unevaluable event). At the time of the report, UNEVALUABLE EVENT (unevaluable event) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The  concomitant medications on use were not provided. No laboratory data was provided. No treatment information was provided.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 16 year-old-patient inadvertently received the Moderna Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old-patient inadvertently received the Moderna Vaccine) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported.) and Product administered to patient of inappropriate age.    On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Apr-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old-patient inadvertently received the Moderna Vaccine). On 08-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year-old-patient inadvertently received the Moderna Vaccine) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jun-2021: Accepted VAERS ICSR as Follow-Up, likely NNI, there was no new info in the SD
Sex: U
Vaccine: TDAP
Symptoms: Neurological symptom
Clinical narrative: SEVERE neurological complications; This case was reported by a consumer via interactive digital media and described the occurrence of neurological symptom in a patient who received DTPa (Reduced antigen) (Tdap Vaccine) for prophylaxis.   On an unknown date, the patient received Tdap Vaccine. On an unknown date, unknown after receiving Tdap Vaccine, the patient experienced neurological symptom. On an unknown date, the outcome of the neurological symptom was unknown.   It was unknown if the reporter considered the neurological symptom to be related to Tdap Vaccine.  Additional details were provided as follows: This case was reported by patient himself/herself. The age at vaccination was not reported. The patient received Tdap vaccine and experience severe neurological complications.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; shingles illness; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient himself/ herself. The age at vaccination was not reported. The patient received the vaccine in February and just finished a week of severe shingles illness. The patient stated Shingrix was 85 percent effective. Unfortunately, it did not prevent or lessen shingles for the patient. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the shot and still got shingles 6 more times \ Suspected Vaccination failure; got shingles 6 more times; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The physician told the reporter that she had Shingles shot and still got shingles 6 more times. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming herpes zoster were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had two shots doesn't work for me/suspected vaccination failure; doesn't work for me; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provide are as follows: The case was reported by patient himself/herself. The age at vaccination was not reported. The patient received 2 shots of Shingles vaccines and they did not work for the patient. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia, Vision blurred
Clinical narrative: double vision; blurry vision; This case was reported by a consumer via call center representative and described the occurrence of double vision in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had a first outbreak of Shingles 1st July 2021 on his left side affecting his eyes and eyebrows). Concurrent medical conditions included diabetes. Concomitant products included famciclovir.   On 11th July 2021, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In July 2021, less than a week after receiving Shingrix, the patient experienced double vision and blurred vision. On an unknown date, the outcome of the double vision and blurred vision were not recovered/not resolved.   It was unknown if the reporter considered the double vision and blurred vision to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. The patient went to his patient care physician (PCP) and was prescribed famciclovir 500 mg bid.  On 11th July 2021, patient went back to his primary care physician office and his famciclovir order was extended and he received the first dose of Shingrix.  Three to four days later he had blurry vision and double vision, both were unresolved.  The patient went to an eye doctor that said his vision should clear up in 4 to 5 months and to cover one eye while driving. The reporter consented to follow up.
Sex: U
Vaccine: MENB
Symptoms: Incorrect route of product administration
Clinical narrative: A first dose / was given Sub q; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received the 1st dose of Bexsero (subcutaneous) and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details provided were as follows: Age at vaccination was not reported. The nurse reported that, the patient received 1st dose of Bexsero subcutaneously which led to intramuscular formulation administered by other route. The reporter did not share any other information. The reporter did not consent to follow-up.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Amblyopia, Chills, Hypoaesthesia, Hypotonia, Migraine
Clinical narrative: MIGRAINE REACTIONS TO SOUNDS; REGURGITATION; LAZY EYE ON THE LEFT SIDE; LEFT SIDE FACE MUSCLE LOOSE; NUMBNESS IN HANDS AND LEGS ARE PREDOMINATELY ON THE RIGHT SIDE; CHILLS; FEVER; This spontaneous report received from a consumer concerned a 79 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and patient had no lifestyle changes prior to high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose was not reported,1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient visited the hospital for high blood pressure and while there, he was offered the Covid-19 vaccine, a few days later started to experience the symptoms, the patient experienced vertigo, nausea, chills, fever, regurgitates, spells of dizziness, blurred vision, migraine reactions to sounds. Patient experienced numbness in hands and legs are predominately on the right side, left side face muscle loose. Neurologist stated patient had severe headaches. Cardiologist stated that his heart was okay. Patient visited eye and ear infirmary specialist, doctor administered Botox injections into his ear. After a week of symptoms began seeking medical advice and had three exams KKG and two others. Neurologist stated points to a rare form of migraine. Treatment medications (dates unspecified) included: botulinum toxin type a. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from regurgitation, migraine reactions to sounds, lazy eye on the left side, numbness in hands and legs are predominately on the right side, left side face muscle loose, fever, and chills. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210817357- Covid-19 vaccine ad26.cov2.s- Migraine reactions to sounds. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Regurgitation
Clinical narrative: MIGRAINE REACTIONS TO SOUNDS; REGURGITATION; LAZY EYE ON THE LEFT SIDE; LEFT SIDE FACE MUSCLE LOOSE; NUMBNESS IN HANDS AND LEGS ARE PREDOMINATELY ON THE RIGHT SIDE; CHILLS; FEVER; This spontaneous report received from a consumer concerned a 79 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: high blood pressure, and patient had no lifestyle changes prior to high blood pressure. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown and expiry: UNKNOWN) dose was not reported,1 total, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient visited the hospital for high blood pressure and while there, he was offered the Covid-19 vaccine, a few days later started to experience the symptoms, the patient experienced vertigo, nausea, chills, fever, regurgitates, spells of dizziness, blurred vision, migraine reactions to sounds. Patient experienced numbness in hands and legs are predominately on the right side, left side face muscle loose. Neurologist stated patient had severe headaches. Cardiologist stated that his heart was okay. Patient visited eye and ear infirmary specialist, doctor administered Botox injections into his ear. After a week of symptoms began seeking medical advice and had three exams KKG and two others. Neurologist stated points to a rare form of migraine. Treatment medications (dates unspecified) included: botulinum toxin type a. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from regurgitation, migraine reactions to sounds, lazy eye on the left side, numbness in hands and legs are predominately on the right side, left side face muscle loose, fever, and chills. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210817357- Covid-19 vaccine ad26.cov2.s- Migraine reactions to sounds. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: MEDICAL HISTORY
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: BLOOD CLOT; This spontaneous report received from a consumer concerned multiple patients. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patients experienced blood clot. The action taken with covid-19 vaccine ad26.cov2.s was not reported. The outcome of blood clot was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20210815176.; Sender's Comments: V0: 20210819161-COVID-19 VACCINE AD26.COV2.S-blood clot. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Musculoskeletal stiffness
Clinical narrative: SUSPECTED STROKE; UNABLE TO MOVE NECK; This spontaneous report received from a female patient of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, 1 total, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. Patient got the Janssen COVID-19 vaccine shot in JUN-2021. She reported that she had a stroke because after she got exposed to the sun, her hands got stiff and she could not move her neck. She said it was not diagnosed as stroke, she was advised to go to the hospital but she did not went to the hospital. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected stroke and unable to move neck was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210819994-Covid-19 vaccine ad26.cov2.s -Suspected stroke. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort, Pruritus, Rash macular, Swelling
Clinical narrative: 4 years old. She stated that 8 or 9 days after receiving the vaccine, her arm started hurting and she developed a big red blotchy area that itched and swelled up; Patient developed a big red blotchy area; Itchy; Swelling; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (4 years old. She stated that 8 or 9 days after receiving the vaccine, her arm started hurting and she developed a big red blotchy area that itched and swelled up), RASH MACULAR (Patient developed a big red blotchy area), PRURITUS (Itchy) and SWELLING (Swelling) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M2A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced SWELLING (Swelling). On 15-Feb-2021, the patient experienced LIMB DISCOMFORT (4 years old. She stated that 8 or 9 days after receiving the vaccine, her arm started hurting and she developed a big red blotchy area that itched and swelled up), RASH MACULAR (Patient developed a big red blotchy area) and PRURITUS (Itchy). At the time of the report, LIMB DISCOMFORT (4 years old. She stated that 8 or 9 days after receiving the vaccine, her arm started hurting and she developed a big red blotchy area that itched and swelled up), RASH MACULAR (Patient developed a big red blotchy area), PRURITUS (Itchy) and SWELLING (Swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The patient took some Tylenol and used 1% hydrocortisone cream to help treat it.
Sex: F
Vaccine: COVID19
Symptoms: Coronavirus test, Coronavirus test positive
Clinical narrative: Tested positive for COVID; A spontaneous report  was received from consumer, concerning herself, a female patient who received Moderna's covid-19 vaccine (mRNA-1273) and tested positive for COVID.  The patient's medical history and concomitant medication was not provided.  On an unknown date the patient received first of two planned doses of mRNA-1273 (lot number unknown) for prophylaxis of covid-19 infection.  On an unknown date the patient tested positive for COVID (Coronavirus test positive).  Action taken with mRNA-1273 in response to the event was unknown.   The outcome of the event coronavirus test positive was unknown.; Reporter's Comments: Although limited information has been provided, based on the known etiology of the disease and known profile of the vaccine, the event is assessed as unlikely related to mRNA-1273 vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: Big itchy rash at injection site; Injection site hot to touch; itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Big itchy rash at injection site), VACCINATION SITE WARMTH (Injection site hot to touch) and VACCINATION SITE PRURITUS (itchy) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, the patient experienced VACCINATION SITE RASH (Big itchy rash at injection site), VACCINATION SITE WARMTH (Injection site hot to touch) and VACCINATION SITE PRURITUS (itchy). At the time of the report, VACCINATION SITE RASH (Big itchy rash at injection site), VACCINATION SITE WARMTH (Injection site hot to touch) and VACCINATION SITE PRURITUS (itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.