chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Incomplete course of vaccination, Injection site rash, Injection site swelling, Rash erythematous
Clinical narrative: Incomplete course of vaccination; Developed a raised / rash; Developed a / hot / rash; Developed a / hot / rash; Developed a / very red rash; This case was reported by a consumer via call center representative and described the occurrence of raised rash in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) for prophylaxis.   In November 2019, the patient received the 1st dose of Menveo. On an unknown date, the patient received the 2nd dose of Menveo. On an unknown date, 2 days after receiving Menveo and not applicable after receiving Menveo, the patient experienced raised rash, rash, hot feeling in hand, red rash and incomplete course of vaccination. On an unknown date, the outcome of the raised rash, rash, hot feeling in hand and red rash were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the raised rash, rash, hot feeling in hand and red rash to be related to Menveo.  Additional details were provided as follows: The case was reported by patient's mother. Post vaccination the patient developed a raised, hot, very red rash from the shoulder to the elbow.  The exact onset date was not known but the mother said she discovered it 2 days after and it seemed to have already started to heal.  The events took a week to resolve.  The patient did not receive the 2nd dose of Menveo which led to incomplete course of vaccination. The reporter was unable to recall which arm. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Pt received the Shingrix  vaccine first dose 2 years ago; This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on unknown date, 2 years prior to reporting).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The reported stated that do they need to start over with the two vaccines. The reporter stated that the first dose was not administered at their facility, no vaccine details available (lot,exp, exact date). No date of birth available. The reporter consented to follow up
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Pt received 2nd dose less than 2 months; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too short in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number 9472F, expiry date 14th October 2022) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 25th March 2021, the patient received the 2nd dose of Shingrix. On 25th March 2021, unknown after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient received 1st dose on 16th February 2021, batch number 4FN5F, expiry date 4th October 2022. Pharmacist reported that patient received 2nd dose less than 2 months, which led to shortening of vaccination schedule. The question was asked, did the patient need to be revaccinated? The reporter consent to follow up.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Wrong product administered
Clinical narrative: Patient received the Pediarix instead of the Dtap- Infanrix; Patient received a fourth dose of Pediarix / 4 doses of the Hep-b; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number K7TF9, expiry date unknown) for prophylaxis.   Co-suspect products included dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 15th July 2020, the patient received Pediarix and Pediarix Pre-Filled Syringe Device. On 15th July 2020, unknown after receiving Pediarix and Pediarix Pre-Filled Syringe Device, the patient experienced wrong vaccine administered and extra dose administered. On an unknown date, the outcome of the wrong vaccine administered and extra dose administered were 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 were provided as follows: The reporter stated that, the patient received  Pediarix instead of the Dtap- Infanrix, which led to wrong vaccine administered. The patient received 4the dose of Pediarix, which led to extra dose administered of hepatitis B component. No reactions reported. The reporter consented to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Near death experience
Clinical narrative: I almost died from a flu vaccine in 2007; This case was reported by a consumer and described the occurrence of near death experience in a patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced near death experience (serious criteria GSK medically significant and life threatening). On an unknown date, the outcome of the near death experience was unknown.   The reporter considered the near death experience to be related to Influenza vaccine.  Additional details were provided as follows: Age at vaccination was not reported. The patient almost died from a flu vaccine in 2007. It was reported that the patient would never forget that.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Dysstasia, Muscle mass, Peripheral swelling
Clinical narrative: couldn't stand on feet; has a large swollen area/swollen twice the normal size/hardness belowhis elbow; has a knot in his arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (has a large swollen area/swollen twice the normal size/hardness belowhis elbow) and DYSSTASIA (couldn't stand on feet) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030C20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No medical history reported).    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, the patient experienced MUSCLE MASS (has a knot in his arm). On 02-Feb-2021, the patient experienced PERIPHERAL SWELLING (has a large swollen area/swollen twice the normal size/hardness belowhis elbow) (seriousness criterion hospitalization). On an unknown date, the patient experienced DYSSTASIA (couldn't stand on feet) (seriousness criterion hospitalization). The patient was hospitalized for 10 days due to DYSSTASIA and PERIPHERAL SWELLING. At the time of the report, PERIPHERAL SWELLING (has a large swollen area/swollen twice the normal size/hardness belowhis elbow), DYSSTASIA (couldn't stand on feet) and MUSCLE MASS (has a knot in his arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case concerns a 76-year-old male was hospitalized with serious unexpected events of dysstasia and peripheral swelling, and nonserious unexpected muscle mass. Based on 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.   Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Email address of primary reporter was added, peripheral swelling was updated as serious due to hospitalization, new event "couldn't stand on feet" and duration of hospitalization was updated.; Sender's Comments: This case concerns a 76-year-old male was hospitalized with serious unexpected events of dysstasia and peripheral swelling, and nonserious unexpected muscle mass. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose abnormal, Blood pressure measurement, Headache, Heart rate, Hyperglycaemia
Clinical narrative: High blood pressure of 188/98; High Blood sugar 283; Headache; A spontaneous report was received from a consumer concerning a 68 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced high blood pressure, high blood sugar level, headache and high heart rate.  The patient's medical history was not provided by the reporter. Concomitant product use was not reported.   On 11 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. After receiving the mRNA-1273 vaccine, patient experienced high blood pressure, high blood sugar level, headache and high heart rate.  Treatment details for events were metoprolol and cavitrol and symptoms improved a little.  Action taken with the drug in response to the event is not provided.  The  outcome of the event, high blood pressure, high blood sugar level, headache and high heart rate was considered to be recovering/resolving at the time of this report.; Reporter's Comments: This case concerns a 68 Y/O M with a serious unexpected event of hypertension, and nonserious unexpected hyperglycemia, and expected headache.  Event onset on day 2 after first dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Hypertension
Clinical narrative: High blood pressure of 188/98; High Blood sugar 283; Headache; A spontaneous report was received from a consumer concerning a 68 year old male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced high blood pressure, high blood sugar level, headache and high heart rate.  The patient's medical history was not provided by the reporter. Concomitant product use was not reported.   On 11 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. After receiving the mRNA-1273 vaccine, patient experienced high blood pressure, high blood sugar level, headache and high heart rate.  Treatment details for events were metoprolol and cavitrol and symptoms improved a little.  Action taken with the drug in response to the event is not provided.  The  outcome of the event, high blood pressure, high blood sugar level, headache and high heart rate was considered to be recovering/resolving at the time of this report.; Reporter's Comments: This case concerns a 68 Y/O M with a serious unexpected event of hypertension, and nonserious unexpected hyperglycemia, and expected headache.  Event onset on day 2 after first dose mRNA-1273. Events resolving. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blindness transient
Clinical narrative: Lost sight in left eye for 30-45 sec; A spontaneous report was received from a consumer concerning a 69-years-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced lost sight in her left eye for 30-45 sec/ blindness transient.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 31 Jan 2021, prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 012M20A) in the left arm for prophylaxis of COVID-19 infection.  On 31 Jan 2021, around 8 pm, the patient experienced a medically significant event lost sight in her left eye for 30-45 sec when she got home. On 01 Feb 2021, twice the patient lost sight again. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.  The outcome of the event, lost sight in her left eye for 30-45 sec was not reported.; Reporter's Comments: 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. Further information has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort, Neuromyopathy, Pyrexia, Sciatica
Clinical narrative: Had neuromuscular issues; Sciatica; Cant put a lot of pressure on his left foot; Low grade fever of 100; A spontaneous report was received from a consumer, concerning a 69- year-old, male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced, neuromuscular issues (Neuromyopathy), Sciatica (Sciatica), Can't put a lot of pressure on his left foot (Limb discomfort) and Low grade fever of 100 (Pyrexia)  The patient's medical history was stiff lower back provided by the reporter. It was reported that, patient tested positive for the antibodies in August. Patient said he never tested positive for the virus and he said that he tested negative but had symptoms. Concomitant medications was not included by the reporter.   On 14 FEB 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 006M20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 15 Feb 2021, the patient experienced neuromuscular issues (Neuromyopathy), Sciatica (Sciatica), Can't put a lot of pressure on his left foot (Limb discomfort) and Low grade fever of 100 (Pyrexia). The event, neuromuscular issues (Neuromyopathy) was medically significant. Treatment details were not reported.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, neuromuscular issues (Neuromyopathy), Sciatica (Sciatica), Can't put a lot of pressure on his left foot (Limb discomfort) and Low grade fever of 100 (Pyrexia) were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Incomplete course of vaccination, Pruritus, Rash, Urticaria, Vaccination site swelling
Clinical narrative: hives on buttocks; outbreak on scalp; little bit itchy; worm and hot; swollen arm; incomplete course of vaccination; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives on buttocks) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PRURITUS (little bit itchy), VACCINATION SITE WARMTH (worm and hot) and VACCINATION SITE SWELLING (swollen arm). On 08-Feb-2021, the patient experienced URTICARIA (hives on buttocks) (seriousness criterion hospitalization). On 18-Feb-2021, the patient experienced RASH (outbreak on scalp). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination). On 08-Feb-2021, PRURITUS (little bit itchy), VACCINATION SITE WARMTH (worm and hot) and VACCINATION SITE SWELLING (swollen arm) had resolved. On 23-Feb-2021, URTICARIA (hives on buttocks) and RASH (outbreak on scalp) had resolved. At the time of the report, INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Hives on buttock cheeks that was severe and was hospitalized and given treatment for the hives included Doxycycline, Prednisone, and Benadryl  Patient then kept postponing the second shot of the vaccine due to the symptoms experienced. Now patient is scheduled to take the second shot on 27Feb2021.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of incomplete course of vaccination (second dose) for mRNA-1273, lot # unknown  with associated AEs vaccination site swelling, vaccination site warmth, rash,prurits, and urticaria.     Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: hives on buttocks; outbreak on scalp; little bit itchy; worm and hot; swollen arm; incomplete course of vaccination; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (hives on buttocks) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PRURITUS (little bit itchy), VACCINATION SITE WARMTH (worm and hot) and VACCINATION SITE SWELLING (swollen arm). On 08-Feb-2021, the patient experienced URTICARIA (hives on buttocks) (seriousness criterion hospitalization). On 18-Feb-2021, the patient experienced RASH (outbreak on scalp). On an unknown date, the patient experienced INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination). On 08-Feb-2021, PRURITUS (little bit itchy), VACCINATION SITE WARMTH (worm and hot) and VACCINATION SITE SWELLING (swollen arm) had resolved. On 23-Feb-2021, URTICARIA (hives on buttocks) and RASH (outbreak on scalp) had resolved. At the time of the report, INCOMPLETE COURSE OF VACCINATION (incomplete course of vaccination) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Hives on buttock cheeks that was severe and was hospitalized and given treatment for the hives included Doxycycline, Prednisone, and Benadryl  Patient then kept postponing the second shot of the vaccine due to the symptoms experienced. Now patient is scheduled to take the second shot on 27Feb2021.   Reporter did not allow further contact; Sender's Comments: This report refers to a case of incomplete course of vaccination (second dose) for mRNA-1273, lot # unknown  with associated AEs vaccination site swelling, vaccination site warmth, rash,prurits, and urticaria.     Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Angioedema, Peripheral swelling, Rash
Clinical narrative: Angioedema; Both legs were swollen from knee to ankles/ hands were swollen; rash on both legs; A spontaneous report was received from a consumer concerning a 74-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced hands, both legs were swollen from knee to ankles, rash on both legs, and angioedema.  The patient's medical history was not provided. Concomitant medications reported were atorvastatin, lisinopril, amlodipine and clonazepam.  On 20 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: 031M20A) in the right arm for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced hands, both legs were swollen from knee to ankles, rash on both legs. The patient went to his doctor and the doctor thought it to be angioedema. Treatment details included antihistamine.  Action taken with mRNA-1273 in response to the events was not applicable.   The outcome of events hands, both legs were swollen from knee to ankles, rash on both legs and angioedema were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain, Palpitations
Clinical narrative: Rapid Heart Beat; Heart rate pounding for hours; Full Body aches; Nausea; Headache; Fever; Chills; A spontaneous report was received from other concerning 77-year-old female patient who developed Rapid Heart Beat, Heart rate pounding for hours, Full Body aches, Chills, Nausea, Headache and Fever.   The patient's medical history included Cardiac issues in 2016 and 2018. Concomitant medication included Motoporal for heart issues.   The patient received their first of two planned doses of mRNA-1273 (Batch number:001AZ10 ) on 26/2/2021 Intramuscularly and suppose to have second dose on 26/3/2021, for prophylaxis of COVID-19 infection.    On 26 Feb 2021, the patient took the shot and experienced fever, chills, full body aches, nausea and headaches. The patient also had very fast heart rate that was pounding for hours, she had the fast heart rate for 24 to 30 hours. The patient also said that she had Covid in Dec 2020 and Jan 2021 for 6 weeks with the same symptoms. The patient was supposed to have her second dose on 26 Mar 2021.  Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events Rapid Heart Beat, Heart rate pounding for hours, Full Body aches, Chills, Nausea, Headache and Fever were resolved on 28 Feb 2021.; Reporter's Comments: This case concerns a 77 Y/O F with a serious unexpected event of tachycardia, and nonserious unexpected palpitations, and expected pyrexia, chills, headache, pain, and nausea.  Event onset the same days as first dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia
Clinical narrative: Rapid Heart Beat; Heart rate pounding for hours; Full Body aches; Nausea; Headache; Fever; Chills; A spontaneous report was received from other concerning 77-year-old female patient who developed Rapid Heart Beat, Heart rate pounding for hours, Full Body aches, Chills, Nausea, Headache and Fever.   The patient's medical history included Cardiac issues in 2016 and 2018. Concomitant medication included Motoporal for heart issues.   The patient received their first of two planned doses of mRNA-1273 (Batch number:001AZ10 ) on 26/2/2021 Intramuscularly and suppose to have second dose on 26/3/2021, for prophylaxis of COVID-19 infection.    On 26 Feb 2021, the patient took the shot and experienced fever, chills, full body aches, nausea and headaches. The patient also had very fast heart rate that was pounding for hours, she had the fast heart rate for 24 to 30 hours. The patient also said that she had Covid in Dec 2020 and Jan 2021 for 6 weeks with the same symptoms. The patient was supposed to have her second dose on 26 Mar 2021.  Treatment information was not provided/unknown.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events Rapid Heart Beat, Heart rate pounding for hours, Full Body aches, Chills, Nausea, Headache and Fever were resolved on 28 Feb 2021.; Reporter's Comments: This case concerns a 77 Y/O F with a serious unexpected event of tachycardia, and nonserious unexpected palpitations, and expected pyrexia, chills, headache, pain, and nausea.  Event onset the same days as first dose mRNA-1273. Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Confusional state, Dysstasia, Gait disturbance, Glomerular filtration rate
Clinical narrative: SORE ARM; ITCHY ARM; FEVER OF 103.7 F; QUEASY; VOMITING; CHILLS; BLACKED OUT AND ASKED WHERE HER CLOTHES WERE FROM AFTER HER DAUGHTER CHANGED HER CLOTHES; SHE COULDNT FOLLOW THE INSTRUCTIONS TO STAND UP/ KNEES BUCKLING; SHE GOT CONFUSED AND LOST HER ABILITY TO WALK AND SIT DOWN; LOST HER ABILITY TO WALK AND SIT DOWN; A spontaneous report was received from a consumer, a 75-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of consciousness, chills, queasy, vomiting, fever of 103.7F, sore and itchy arms, confusion, lost ability to walk and sit down, knees were buckling, blacked out.   The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the events were quetiapine, atorvastatin 10mg, tramadol, hydrocodone/APAP 5/325mg, gabapentin 300mg, Tylenol PM 500mg, Voltaren cream, Miralax.  On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030M20A) intramuscularly in the right deltoid muscle for prophylaxis of COVID-19 infection.   On 11 Feb 2021, next day after exposure to the first dose, the patient experienced, chills, queasy, vomiting, fever of 103.7F which went down to 100F. On 12 Feb 2021 (Friday) the patient had sore and itchy arms and lost the ability to walk and sit down to extend that was carried to the bathroom. The patient got confusion, knees were buckling and even blacked out. Lab exam performed were reported as GRF-21%. Treatment  for the event included Aleve and Nyquil.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, chills, queasy, vomiting, fever of 103.7F, sore and itchy arms, confusion, lost ability to walk and sit down, knees were buckling and black out was considered to be recovered/ resolved.; Reporter's Comments: This case concerns a 75-year-old female who had serious unexpected loss of consciousness, dysstasia, gait disturbance, confusional state and nonserious expected pyrexia, chills, nausea, vomiting, injection site pain, injection site pruritus.  Event onset 3 days after first dose mRNA-1273. Treatment with naproxen. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Loss of consciousness, Nausea, Pyrexia
Clinical narrative: SORE ARM; ITCHY ARM; FEVER OF 103.7 F; QUEASY; VOMITING; CHILLS; BLACKED OUT AND ASKED WHERE HER CLOTHES WERE FROM AFTER HER DAUGHTER CHANGED HER CLOTHES; SHE COULDNT FOLLOW THE INSTRUCTIONS TO STAND UP/ KNEES BUCKLING; SHE GOT CONFUSED AND LOST HER ABILITY TO WALK AND SIT DOWN; LOST HER ABILITY TO WALK AND SIT DOWN; A spontaneous report was received from a consumer, a 75-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of consciousness, chills, queasy, vomiting, fever of 103.7F, sore and itchy arms, confusion, lost ability to walk and sit down, knees were buckling, blacked out.   The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the events were quetiapine, atorvastatin 10mg, tramadol, hydrocodone/APAP 5/325mg, gabapentin 300mg, Tylenol PM 500mg, Voltaren cream, Miralax.  On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030M20A) intramuscularly in the right deltoid muscle for prophylaxis of COVID-19 infection.   On 11 Feb 2021, next day after exposure to the first dose, the patient experienced, chills, queasy, vomiting, fever of 103.7F which went down to 100F. On 12 Feb 2021 (Friday) the patient had sore and itchy arms and lost the ability to walk and sit down to extend that was carried to the bathroom. The patient got confusion, knees were buckling and even blacked out. Lab exam performed were reported as GRF-21%. Treatment  for the event included Aleve and Nyquil.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, chills, queasy, vomiting, fever of 103.7F, sore and itchy arms, confusion, lost ability to walk and sit down, knees were buckling and black out was considered to be recovered/ resolved.; Reporter's Comments: This case concerns a 75-year-old female who had serious unexpected loss of consciousness, dysstasia, gait disturbance, confusional state and nonserious expected pyrexia, chills, nausea, vomiting, injection site pain, injection site pruritus.  Event onset 3 days after first dose mRNA-1273. Treatment with naproxen. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: SORE ARM; ITCHY ARM; FEVER OF 103.7 F; QUEASY; VOMITING; CHILLS; BLACKED OUT AND ASKED WHERE HER CLOTHES WERE FROM AFTER HER DAUGHTER CHANGED HER CLOTHES; SHE COULDNT FOLLOW THE INSTRUCTIONS TO STAND UP/ KNEES BUCKLING; SHE GOT CONFUSED AND LOST HER ABILITY TO WALK AND SIT DOWN; LOST HER ABILITY TO WALK AND SIT DOWN; A spontaneous report was received from a consumer, a 75-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced loss of consciousness, chills, queasy, vomiting, fever of 103.7F, sore and itchy arms, confusion, lost ability to walk and sit down, knees were buckling, blacked out.   The patient's medical history was not provided. Concomitant products known to have been used by the patient, within two weeks prior to the events were quetiapine, atorvastatin 10mg, tramadol, hydrocodone/APAP 5/325mg, gabapentin 300mg, Tylenol PM 500mg, Voltaren cream, Miralax.  On 10 Feb 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 030M20A) intramuscularly in the right deltoid muscle for prophylaxis of COVID-19 infection.   On 11 Feb 2021, next day after exposure to the first dose, the patient experienced, chills, queasy, vomiting, fever of 103.7F which went down to 100F. On 12 Feb 2021 (Friday) the patient had sore and itchy arms and lost the ability to walk and sit down to extend that was carried to the bathroom. The patient got confusion, knees were buckling and even blacked out. Lab exam performed were reported as GRF-21%. Treatment  for the event included Aleve and Nyquil.  Action taken with mRNA-1273 in response to the events was unknown.   The outcome of the events, chills, queasy, vomiting, fever of 103.7F, sore and itchy arms, confusion, lost ability to walk and sit down, knees were buckling and black out was considered to be recovered/ resolved.; Reporter's Comments: This case concerns a 75-year-old female who had serious unexpected loss of consciousness, dysstasia, gait disturbance, confusional state and nonserious expected pyrexia, chills, nausea, vomiting, injection site pain, injection site pruritus.  Event onset 3 days after first dose mRNA-1273. Treatment with naproxen. Events resolved. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Eye infection bacterial, Eye pain
Clinical narrative: Muscle ache; eye infection; Chills; Nausea; swollen and closed eye; eye that was numb; itching in the eye; eye painful; Loss of appetite; Headache; Pain in the right shoulder; swelling in the right arm that was similar like a baseball; pain in right arm; weakness in right arm; A spontaneous/solicited report was received from a consumer who is 74 year female who experienced a  weakness in right arm, pain in right arm, swelling in the right arm that likened to a baseball, pain in right shoulder, and a swollen eye which resulted in an eye infection.  The patient's medical history was not provided. Concomitant product use provided was Lamotrigine 100 mg,  On 22-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 23-FEB-2021, the patient states she started experiencing  weakness in right arm, pain in right arm, swelling in the right arm that likened to a baseball, and pain in the right shoulder. On 24-FEB-2021, she woke up with swollen and closed eye that was numb, itching and painful, Additionally she was experiencing nausea, loss of appetite, headache, chills. Patient states that she made an appointment with eye Dr to get her eye checked up. The eye Dr ended up diagnosed her with an eye infection and prescribed an eye drop called Erythromycin. Patient said her symptoms continue on and on Friday she had muscle ache, muscle pain, pain went from right side to left side. On Saturday, the pain was left arm and going back forth between left and right arm, itching, and chills. On Sunday and Monday, experienced the same symptoms until Monday afternoon or evening started felling better.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events,  weakness in right arm, pain in right arm, swelling in the right arm that likened to a baseball, pain in right shoulder, and a swollen eye which resulted in an eye infection is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events and a causal relationship cannot be excluded. Very limited information regarding the event (Eye infection bacterial, hypoaesthesia eye, eye pruritus, and eye pain,) has been provided at this time. Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pruritus, Eye swelling, Headache, Hypoaesthesia eye, Muscular weakness
Clinical narrative: Muscle ache; eye infection; Chills; Nausea; swollen and closed eye; eye that was numb; itching in the eye; eye painful; Loss of appetite; Headache; Pain in the right shoulder; swelling in the right arm that was similar like a baseball; pain in right arm; weakness in right arm; A spontaneous/solicited report was received from a consumer who is 74 year female who experienced a  weakness in right arm, pain in right arm, swelling in the right arm that likened to a baseball, pain in right shoulder, and a swollen eye which resulted in an eye infection.  The patient's medical history was not provided. Concomitant product use provided was Lamotrigine 100 mg,  On 22-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 23-FEB-2021, the patient states she started experiencing  weakness in right arm, pain in right arm, swelling in the right arm that likened to a baseball, and pain in the right shoulder. On 24-FEB-2021, she woke up with swollen and closed eye that was numb, itching and painful, Additionally she was experiencing nausea, loss of appetite, headache, chills. Patient states that she made an appointment with eye Dr to get her eye checked up. The eye Dr ended up diagnosed her with an eye infection and prescribed an eye drop called Erythromycin. Patient said her symptoms continue on and on Friday she had muscle ache, muscle pain, pain went from right side to left side. On Saturday, the pain was left arm and going back forth between left and right arm, itching, and chills. On Sunday and Monday, experienced the same symptoms until Monday afternoon or evening started felling better.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events,  weakness in right arm, pain in right arm, swelling in the right arm that likened to a baseball, pain in right shoulder, and a swollen eye which resulted in an eye infection is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events and a causal relationship cannot be excluded. Very limited information regarding the event (Eye infection bacterial, hypoaesthesia eye, eye pruritus, and eye pain,) has been provided at this time. Further information has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Vaccination site pain, Vaccination site swelling
Clinical narrative: Muscle ache; eye infection; Chills; Nausea; swollen and closed eye; eye that was numb; itching in the eye; eye painful; Loss of appetite; Headache; Pain in the right shoulder; swelling in the right arm that was similar like a baseball; pain in right arm; weakness in right arm; A spontaneous/solicited report was received from a consumer who is 74 year female who experienced a  weakness in right arm, pain in right arm, swelling in the right arm that likened to a baseball, pain in right shoulder, and a swollen eye which resulted in an eye infection.  The patient's medical history was not provided. Concomitant product use provided was Lamotrigine 100 mg,  On 22-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the right arm for prophylaxis of COVID-19 infection.    On 23-FEB-2021, the patient states she started experiencing  weakness in right arm, pain in right arm, swelling in the right arm that likened to a baseball, and pain in the right shoulder. On 24-FEB-2021, she woke up with swollen and closed eye that was numb, itching and painful, Additionally she was experiencing nausea, loss of appetite, headache, chills. Patient states that she made an appointment with eye Dr to get her eye checked up. The eye Dr ended up diagnosed her with an eye infection and prescribed an eye drop called Erythromycin. Patient said her symptoms continue on and on Friday she had muscle ache, muscle pain, pain went from right side to left side. On Saturday, the pain was left arm and going back forth between left and right arm, itching, and chills. On Sunday and Monday, experienced the same symptoms until Monday afternoon or evening started felling better.  Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The outcome of the events,  weakness in right arm, pain in right arm, swelling in the right arm that likened to a baseball, pain in right shoulder, and a swollen eye which resulted in an eye infection is unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events and a causal relationship cannot be excluded. Very limited information regarding the event (Eye infection bacterial, hypoaesthesia eye, eye pruritus, and eye pain,) has been provided at this time. Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (COVID-19) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included METFORMIN, ATORVASTATIN and INSULIN for an unknown indication.    On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization). At the time of the report, COVID-19 (COVID-19) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication include blood pressure medication. Treatment for the event COVID-19 include antibody infusion.  Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related.; Sender's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Headache, Heart rate, Vaccination site pain
Clinical narrative: A fib; sore arm; Headache; A Spontaneous  report was received from a consumer concerning a 70 Years old male patient,  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Atrial Fibrillation, Headache, Vaccination site pain.  The patient's medical history was not provided. No relevant concomitant medications were reported. No information on allergies were provided. The reported stated that the patient was physically and mentally healthy before vaccination   On 29 Jan   2021 , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011M20A)  via unknown route into her left arm for prophylaxis of COVID-19 infection .   On 30 Jan 2021  Patient experienced events such as Atrial Fibrillation, Headache, Vaccination site pain .Investigations include his heart rate which was rapid. Cardioversion procedure was followed to restore the heart rhythm.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome for the event Atrial Fibrillation was recovered on same date with the treatment procedure. The outcome of events Headache, Vaccination site pain were considered unknown.; Reporter's Comments: This case concerns a 70 Y/O M with a serious unexpected event of atrial fibrillation, and nonserious expected vaccination site pain and headache. Event onset on Day 2 after first dose mRNA-1273. Treatment included cardioversion.  Atrial fibrillation resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Died; A spontaneus report was received from a consumer concerning a male patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and died.   The patient's medical history was not provided.  No relevant concomitant medications were reported.     On an unknown date, prior to onset of the event, the patient received their dose of mRNA-1273 (lot/batch number: unknown) for prophylaxis of COVID-19 infection.  On an unknown date, the patient died.  Action taken with mRNA-1273 in response to the event was not applicable.  The patient died on an unspecified date. The cause of death was unknown. Plans for an autopsy were unknown.; Reporter's Comments: Very limited information regarding the event has been provided at this time and is insufficient for causality assessment. The cause of death was unknown. Plans for an autopsy were unknown.  Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Neutropenia, White blood cell count
Clinical narrative: Tired; Aches all over the body; Neutropenia; A spontaneous report was received from a consumer (patient) concerning a 70-year-old, female patient was who received Moderna's COVID-19 Vaccine (mRNA-1273) and had neutropenia (neutropenia), tired (fatigue), aches all over the body (myalgia).  The patient's medical history included leukemia. No concomitant medications were reported.   On 01 Feb 2021, five days before the onset of events, the patient received their second of the two planned doses of mRNA-1273 (Batch number: 012M20A), intramuscularly for the prophylaxis of COVID-19 infection.  On 05 Feb 2021, the patient had a low count white cells (neutropenia). On 12 Feb 2021, she repeated the blood test and the white cells were perfect. On 02 Mar 2021, the patient was tired and had aches all over the body.  No treatment information was provided.  The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event is not applicable.   The event, neutropenia was considered recovered/resolved on 12 Mar 2021.  The outcome of the events, tired (fatigue) and aches all over the body (myalgia), was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Bad rash all over body; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of RASH (Bad rash all over body) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date (several days after the vaccination), the patient experienced RASH (Bad rash all over body) (seriousness criterion hospitalization). At the time of the report, RASH (Bad rash all over body) outcome was unknown. 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.