chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Intensive care, Neuropathy peripheral, Pain
Clinical narrative: Neuropathy from the bottom of her feet to her bra line / Admitted into the ICU for three days; Fatigue; Pain; This case was reported by a consumer via call center representative and described the occurrence of neuropathy in a female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   In September 2015, the patient received Boostrix (intramuscular) and Boostrix Pre-Filled Syringe Device. In September 2015, 1 day after receiving Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced neuropathy (serious criteria hospitalization and GSK medically significant), fatigue (serious criteria hospitalization) and pain (serious criteria hospitalization). The patient was treated with morphine iv drip and pregabalin (Lyrica). On an unknown date, the outcome of the neuropathy, fatigue and pain were unknown.   It was unknown if the reporter considered the neuropathy, fatigue and pain to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   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 reported as follows: The age at vaccination was not reported. On Friday, the patient received Boostrix and by Saturday, fatigue had started and by Tuesday, she had Neuropathy from the bottom of her feet to her bra line. The patient was admitted into the ICU for three days. The patient was in such Pain, Morphine IV did not help. She was then prescribed Lyrica, and within three hours, she was able to be discharged. All information was not available. The reporter did not consent to follow-up.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Loss of consciousness, Malaise, Pain
Clinical narrative: while taking blood pressure patient passed out; not feel well; fever; aches; headache; chills; A spontaneous report was received from a nurse concerning a 66-year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, aches, headache, chills, did not feel well and passed out.  The patient's medical history included atrial fibrillation following symptoms of feeling sick, headache and chest discomfort in September 2020. Current conditions included elevated blood pressure (BP) and a shrimp/shellfish allergy. Concomitant medications included apixaban, carvedilol, lisinopril and vitamin D.  On 04 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 013M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 05 Feb 2021, one day after receiving the vaccine, the patient experienced fever, aches, headache and chills. She took paracetamol and felt better. On that same day at approximately 1330, 24 hours after the vaccine, the patient was preparing a sandwich and was not feeling well. She sat in a chair to take her blood pressure and passed out.  At some point, it was reported that patient was admitted to the hospital for a five-day stay.  (admission/discharge dates not reported).  Treatment for the events included paracetamol.  There was not change planned to the dosing schedule of mRNA-1273 in response to the events as it is known that on 05 Mar 2021, the patient received the second of two planned doses of mRNA-1273 (Batch Number: 002A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  The outcome of the events, fever, aches, headache, chills, not feel well and passed out,  was considered recovered/resolved on an unspecified date.; 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.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: while taking blood pressure patient passed out; not feel well; fever; aches; headache; chills; A spontaneous report was received from a nurse concerning a 66-year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever, aches, headache, chills, did not feel well and passed out.  The patient's medical history included atrial fibrillation following symptoms of feeling sick, headache and chest discomfort in September 2020. Current conditions included elevated blood pressure (BP) and a shrimp/shellfish allergy. Concomitant medications included apixaban, carvedilol, lisinopril and vitamin D.  On 04 Feb 2021, the patient received the first of two planned doses of mRNA-1273 (Batch Number: 013M20A) intramuscularly in left arm for prophylaxis of COVID-19 infection. On 05 Feb 2021, one day after receiving the vaccine, the patient experienced fever, aches, headache and chills. She took paracetamol and felt better. On that same day at approximately 1330, 24 hours after the vaccine, the patient was preparing a sandwich and was not feeling well. She sat in a chair to take her blood pressure and passed out.  At some point, it was reported that patient was admitted to the hospital for a five-day stay.  (admission/discharge dates not reported).  Treatment for the events included paracetamol.  There was not change planned to the dosing schedule of mRNA-1273 in response to the events as it is known that on 05 Mar 2021, the patient received the second of two planned doses of mRNA-1273 (Batch Number: 002A21A) intramuscularly in left arm for prophylaxis of COVID-19 infection.  The outcome of the events, fever, aches, headache, chills, not feel well and passed out,  was considered recovered/resolved on an unspecified date.; 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.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Balance disorder, Chest pain, Fatigue, Influenza like illness
Clinical narrative: Flue like symptoms; Little off balance; Severe mid chest pain; Fatigue; Arrhythmia a couple of times; Tremors a couple of times; Itching all over the body; A spontaneous report  was received from a consumer concerning a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itching all over the body/pruritus, fatigue, flue like symptoms/influenza like illness, little off balance/balance disorder, tremors and arrhythmia(intervention/medically important) a couple of times and severe mid chest pain/ chest pain.   The patient's medical history as provided by the reporter included cochlear implant. Concomitant medications reported included domperidone.  On 09 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 12 Feb 2021, the patient experienced itching all over the body. On an unspecified date, the patient experienced fatigue, flue like symptoms, little off balance, tremors and arrhythmia a couple of times and severe mid chest pain.  Lab details were not provided by the reporter.  Treatment for the events included ibuprofen.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of the events, itching all over the body, fatigue, flue like symptoms, little off balance, tremors and arrhythmia a couple of times and severe mid chest pain were unknown.; Reporter's Comments: events of unexpected influenza-like illness, chest pain, tremor, balance disorder,  pruritus,  and expected fatigue.  Event onset occurred Day 4 after the first dose of mRNA-1273. Treatment with ibuprofen. Event outcomes unknown. 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tremor
Clinical narrative: Flue like symptoms; Little off balance; Severe mid chest pain; Fatigue; Arrhythmia a couple of times; Tremors a couple of times; Itching all over the body; A spontaneous report  was received from a consumer concerning a 65-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itching all over the body/pruritus, fatigue, flue like symptoms/influenza like illness, little off balance/balance disorder, tremors and arrhythmia(intervention/medically important) a couple of times and severe mid chest pain/ chest pain.   The patient's medical history as provided by the reporter included cochlear implant. Concomitant medications reported included domperidone.  On 09 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013M20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 12 Feb 2021, the patient experienced itching all over the body. On an unspecified date, the patient experienced fatigue, flue like symptoms, little off balance, tremors and arrhythmia a couple of times and severe mid chest pain.  Lab details were not provided by the reporter.  Treatment for the events included ibuprofen.  Action taken with mRNA-1273 in response to the events were not reported.   The outcome of the events, itching all over the body, fatigue, flue like symptoms, little off balance, tremors and arrhythmia a couple of times and severe mid chest pain were unknown.; Reporter's Comments: events of unexpected influenza-like illness, chest pain, tremor, balance disorder,  pruritus,  and expected fatigue.  Event onset occurred Day 4 after the first dose of mRNA-1273. Treatment with ibuprofen. Event outcomes unknown. 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Asthenia, Blood pressure measurement, Dizziness, Feeling abnormal
Clinical narrative: Extremely dizzy; Don't remember nothing; Felt like she was going to died; Felt so sick; Completely unconscious/passed out; High blood pressure 215 over 156; Vomiting for 1 hour constantly/threw up; Nauseate; Headache like someone is pressure her brain; Fast heartbeat; Weak; A spontaneous report was received from a consumer concerning a 73-year-old, female patient who received the Moderna COVID-19 (mRNA-1273) vaccine and experienced the following:  completely unconscious/passed out(loss of consciousness), dizziness, vomiting for 1 hour constantly/threw up (vomiting), don't remember nothing (amnesia), felt like she was going to died (feeling abnormal), high blood pressure 215 over 156 (hypertension), felt so sick (malaise), headache like someone is pressure her brain (headache), fast heartbeat (tachycardia), nauseate (nausea) and weak (asthenia).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin, bupropion hydrochloride, cetirizine hydrochloride, anxiety medicines, clonazepam, metformin,  metoprolol, and trazodone.  On 01 Mar 2021, the patient received the first dose of two planned doses of mRNA-1273 (Batch number: unknown) and 45 minutes later was extremely dizzy. At home one hour later she started to vomit for one hour constantly, became completely unconscious, didn't remember anything, and was really scared. The last thing she remembered was telling her husband: you need to call somebody because she felt like she was going to die. The patient was taken by ambulance to the hospital and while in the ambulance, the patient was administered medicines for nausea and blood pressure. The blood pressure measurement taken in the ambulance was 215 over 156.  The patient didn't know her address or anything else.  She was released to go home after a few hours, but still felt so sick.  On Sunday night (07-Mar-2021), the patient threw up again.  On an unspecified date, she had a headache like someone was putting pressure on her brain; she also had a fast heartbeat.  Since the vaccine, the patient reported feeling really nauseous and remembering nothing about it.  She is still weak. Treatment information included ondansetron medicine for nausea.  Action taken with mRNA-1273 in response to the events was unknown.   At the time of reporting, the outcome of the event, weak, was considered not recovered/not resolved. The outcome of the events, completely unconscious/ passed out, dizziness, vomiting for 1 hour constantly/threw up, don't remember nothing, felt like she was going to died, high blood pressure 215 over 156 , felt so sick, headache like someone is pressure her brain, fast heartbeat, and nauseate 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 event, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Loss of consciousness, Malaise, Nausea
Clinical narrative: Extremely dizzy; Don't remember nothing; Felt like she was going to died; Felt so sick; Completely unconscious/passed out; High blood pressure 215 over 156; Vomiting for 1 hour constantly/threw up; Nauseate; Headache like someone is pressure her brain; Fast heartbeat; Weak; A spontaneous report was received from a consumer concerning a 73-year-old, female patient who received the Moderna COVID-19 (mRNA-1273) vaccine and experienced the following:  completely unconscious/passed out(loss of consciousness), dizziness, vomiting for 1 hour constantly/threw up (vomiting), don't remember nothing (amnesia), felt like she was going to died (feeling abnormal), high blood pressure 215 over 156 (hypertension), felt so sick (malaise), headache like someone is pressure her brain (headache), fast heartbeat (tachycardia), nauseate (nausea) and weak (asthenia).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin, bupropion hydrochloride, cetirizine hydrochloride, anxiety medicines, clonazepam, metformin,  metoprolol, and trazodone.  On 01 Mar 2021, the patient received the first dose of two planned doses of mRNA-1273 (Batch number: unknown) and 45 minutes later was extremely dizzy. At home one hour later she started to vomit for one hour constantly, became completely unconscious, didn't remember anything, and was really scared. The last thing she remembered was telling her husband: you need to call somebody because she felt like she was going to die. The patient was taken by ambulance to the hospital and while in the ambulance, the patient was administered medicines for nausea and blood pressure. The blood pressure measurement taken in the ambulance was 215 over 156.  The patient didn't know her address or anything else.  She was released to go home after a few hours, but still felt so sick.  On Sunday night (07-Mar-2021), the patient threw up again.  On an unspecified date, she had a headache like someone was putting pressure on her brain; she also had a fast heartbeat.  Since the vaccine, the patient reported feeling really nauseous and remembering nothing about it.  She is still weak. Treatment information included ondansetron medicine for nausea.  Action taken with mRNA-1273 in response to the events was unknown.   At the time of reporting, the outcome of the event, weak, was considered not recovered/not resolved. The outcome of the events, completely unconscious/ passed out, dizziness, vomiting for 1 hour constantly/threw up, don't remember nothing, felt like she was going to died, high blood pressure 215 over 156 , felt so sick, headache like someone is pressure her brain, fast heartbeat, and nauseate 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 event, a causal relationship cannot be excluded.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Vomiting
Clinical narrative: Extremely dizzy; Don't remember nothing; Felt like she was going to died; Felt so sick; Completely unconscious/passed out; High blood pressure 215 over 156; Vomiting for 1 hour constantly/threw up; Nauseate; Headache like someone is pressure her brain; Fast heartbeat; Weak; A spontaneous report was received from a consumer concerning a 73-year-old, female patient who received the Moderna COVID-19 (mRNA-1273) vaccine and experienced the following:  completely unconscious/passed out(loss of consciousness), dizziness, vomiting for 1 hour constantly/threw up (vomiting), don't remember nothing (amnesia), felt like she was going to died (feeling abnormal), high blood pressure 215 over 156 (hypertension), felt so sick (malaise), headache like someone is pressure her brain (headache), fast heartbeat (tachycardia), nauseate (nausea) and weak (asthenia).  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included atorvastatin, bupropion hydrochloride, cetirizine hydrochloride, anxiety medicines, clonazepam, metformin,  metoprolol, and trazodone.  On 01 Mar 2021, the patient received the first dose of two planned doses of mRNA-1273 (Batch number: unknown) and 45 minutes later was extremely dizzy. At home one hour later she started to vomit for one hour constantly, became completely unconscious, didn't remember anything, and was really scared. The last thing she remembered was telling her husband: you need to call somebody because she felt like she was going to die. The patient was taken by ambulance to the hospital and while in the ambulance, the patient was administered medicines for nausea and blood pressure. The blood pressure measurement taken in the ambulance was 215 over 156.  The patient didn't know her address or anything else.  She was released to go home after a few hours, but still felt so sick.  On Sunday night (07-Mar-2021), the patient threw up again.  On an unspecified date, she had a headache like someone was putting pressure on her brain; she also had a fast heartbeat.  Since the vaccine, the patient reported feeling really nauseous and remembering nothing about it.  She is still weak. Treatment information included ondansetron medicine for nausea.  Action taken with mRNA-1273 in response to the events was unknown.   At the time of reporting, the outcome of the event, weak, was considered not recovered/not resolved. The outcome of the events, completely unconscious/ passed out, dizziness, vomiting for 1 hour constantly/threw up, don't remember nothing, felt like she was going to died, high blood pressure 215 over 156 , felt so sick, headache like someone is pressure her brain, fast heartbeat, and nauseate 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 event, a causal relationship cannot be excluded.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Fall, Feeling abnormal, Haemorrhage, Headache
Clinical narrative: It was weird again; Turning into a bruise; Felt crappy; A couple of bad breakthrough bleeding episodes; Menstrual cycle was interrupted; Felt off; In her right leg raised hive; Headache; A spontaneous report was received from a consumer concerning a 21-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a couple of bad breakthrough bleeding episodes, Menstrual cycle was interrupted, Felt crappy, Felt off, In her right leg raised hive, Headache, Turning into a bruise and It was weird again.  The patient's medical history was reported as migraines. Concomitant medications were not reported.  On 27 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013A21A) intramuscularly in the right thigh for prophylaxis of COVID-19 infection.   On 27 FEB 2021, the patient experienced Raised hive (Urticaria) about the size of a half dollar, after that she "felt off" (fall) had a headache (Headache) and Felt crappy (Malaise), and she had a couple of bad breakthrough bleeding episodes (Hemorrhage) which was assessed as medically significant, and the patient also experienced interrupted Menstrual cycle (Menstrual disorder). On 07 MAR 2021, the patient experienced Turning into a bruise (Contusion) and on 08 MAR 2021 it was weird again (Feeling abnormal).  Laboratory details were not provided.  Treatment medication was provided as Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events Hemorrhage, Menstrual disorder, Contusion, Malaise, Feeling abnormal, Fall, Urticaria and Headache was considered as 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.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Menstrual disorder, Urticaria
Clinical narrative: It was weird again; Turning into a bruise; Felt crappy; A couple of bad breakthrough bleeding episodes; Menstrual cycle was interrupted; Felt off; In her right leg raised hive; Headache; A spontaneous report was received from a consumer concerning a 21-year-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a couple of bad breakthrough bleeding episodes, Menstrual cycle was interrupted, Felt crappy, Felt off, In her right leg raised hive, Headache, Turning into a bruise and It was weird again.  The patient's medical history was reported as migraines. Concomitant medications were not reported.  On 27 Feb 2021, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: 013A21A) intramuscularly in the right thigh for prophylaxis of COVID-19 infection.   On 27 FEB 2021, the patient experienced Raised hive (Urticaria) about the size of a half dollar, after that she "felt off" (fall) had a headache (Headache) and Felt crappy (Malaise), and she had a couple of bad breakthrough bleeding episodes (Hemorrhage) which was assessed as medically significant, and the patient also experienced interrupted Menstrual cycle (Menstrual disorder). On 07 MAR 2021, the patient experienced Turning into a bruise (Contusion) and on 08 MAR 2021 it was weird again (Feeling abnormal).  Laboratory details were not provided.  Treatment medication was provided as Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events Hemorrhage, Menstrual disorder, Contusion, Malaise, Feeling abnormal, Fall, Urticaria and Headache was considered as 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure increased, Blood pressure measurement, Fatigue, Injection site pain
Clinical narrative: Syncope; things went dark; almost passed out twice; BP spikes; left arm pain at the site of the injection; fatigue; A spontaneous report was received from a Consumer concerning a  71 Years-old female patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and experienced  almost fainted/presyncope, Fainting/Syncope, Blackout/Loss of consciousness, Injection site pain, BP spikes and Fatigue.  The patient's medical history was provided as Atrial Fibrillation, Syncope and Diabetes (borderline). Relevant concomitant medications were reported as Warfarin, Cimetidine, Carvedilol, Spironolactone, Glipizide, Magnesium, MiraLAX, Probiotics, Stool softener and Clonidine PRN.    On 26 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route in the left arm for prophylaxis of COVID-19 infection. On 26 Feb 2021, after receiving the first Moderna Covid -19 Vaccine the patient experienced dizziness, increased heart rate, left arm pain at injection site. She reported of "almost passed out, and things went dark" on day 4 (02FEB2021) and day 5 (03FEB2021) after the vaccination. She reported that she had one syncopal episode 02FEB2021 while she was standing around the stove, and 2nd syncopal episode occurred on 03FEB2021 while she was getting out of shower. She also has mild fatigue since the vaccination. Fainting and Blackout were medically significant.  Laboratory details were provided by her BP readings which are as follows:  BP reading on 02MAR2021 -- 102/56, 168/69, 103/54 BP reading on 03MAR2021 -- 180/90, 193/75, 201/91, 215/115 (took Clonidine) BP reading on 04MAR2021 -- 176/81, 200/87 BP reading on 06MAR2021 -- 200/90, 220/92 (took Clonidine) She checked her blood glucose levels daily, and its "within normal" limits. Treatment details was provided as Clonidine PRN.   Action taken with mRNA-1273 in response to the events was unknown.  On unspecified date, the outcome of the events injection site pain was Recovered/Resolved. At the time of this report the outcome of the events Fainting, Blackout and Fatigue were unknown.; Reporter's Comments: Based on the information provided, the established safety profile of mRNA-1273 vaccine and a strong temporal association between the reported events and the administration of mRNA-1273 vaccine, a causal association cannot be excluded. Injection site pain and Fatigue are consistent with the safety profile of the vaccine.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Presyncope, Syncope
Clinical narrative: Syncope; things went dark; almost passed out twice; BP spikes; left arm pain at the site of the injection; fatigue; A spontaneous report was received from a Consumer concerning a  71 Years-old female patient who received Moderna 's COVID-19 vaccine (mRNA-1273) and experienced  almost fainted/presyncope, Fainting/Syncope, Blackout/Loss of consciousness, Injection site pain, BP spikes and Fatigue.  The patient's medical history was provided as Atrial Fibrillation, Syncope and Diabetes (borderline). Relevant concomitant medications were reported as Warfarin, Cimetidine, Carvedilol, Spironolactone, Glipizide, Magnesium, MiraLAX, Probiotics, Stool softener and Clonidine PRN.    On 26 Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) unknown route in the left arm for prophylaxis of COVID-19 infection. On 26 Feb 2021, after receiving the first Moderna Covid -19 Vaccine the patient experienced dizziness, increased heart rate, left arm pain at injection site. She reported of "almost passed out, and things went dark" on day 4 (02FEB2021) and day 5 (03FEB2021) after the vaccination. She reported that she had one syncopal episode 02FEB2021 while she was standing around the stove, and 2nd syncopal episode occurred on 03FEB2021 while she was getting out of shower. She also has mild fatigue since the vaccination. Fainting and Blackout were medically significant.  Laboratory details were provided by her BP readings which are as follows:  BP reading on 02MAR2021 -- 102/56, 168/69, 103/54 BP reading on 03MAR2021 -- 180/90, 193/75, 201/91, 215/115 (took Clonidine) BP reading on 04MAR2021 -- 176/81, 200/87 BP reading on 06MAR2021 -- 200/90, 220/92 (took Clonidine) She checked her blood glucose levels daily, and its "within normal" limits. Treatment details was provided as Clonidine PRN.   Action taken with mRNA-1273 in response to the events was unknown.  On unspecified date, the outcome of the events injection site pain was Recovered/Resolved. At the time of this report the outcome of the events Fainting, Blackout and Fatigue were unknown.; Reporter's Comments: Based on the information provided, the established safety profile of mRNA-1273 vaccine and a strong temporal association between the reported events and the administration of mRNA-1273 vaccine, a causal association cannot be excluded. Injection site pain and Fatigue are consistent with the safety profile of the vaccine.
Sex: M
Vaccine: COVID19
Symptoms: Renal impairment
Clinical narrative: Kidney function worse; A spontaneous report was received from a consumer concerning a male patient of an unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced renal impairement.  The patient's medical history includes diagnosis of COVID-19 infection on an unknown date in October 2020, which required admission to the ICU for 5 days, and chronic kidney disease stage III.  On 27-Feb-2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number:unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unknown date in March 2021 at the patient's physical, his primary care physician informed him of worsening kidney function. Patient inquired if his health condition had any relation with the Moderna COVID-19 vaccine.   Action taken with mRNA-1273 in response to the events was reported as unknown.   The outcome of the event worse kidney function was considered 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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis, Cardiac stress test, Cardiovascular symptom, Chest discomfort, Computerised tomogram
Clinical narrative: cardiovascular event; Tightness in chest; Difficulty Breathing; Bronchitis; A Spontaneous report  was received from a health care professional concerning a 79 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Cardiovascular symptom, Chest discomfort, Dyspnea, Bronchitis.  The patient's medical history as provided by the reporter included Neuropathy of feet, elevated Cholesterol, Osteoarthritis, Aortic aneurysm. Concomitant medication included Levothyroxine sodium, Sumatriptan, Rosuvastatin, Piroxicam and Vitamin D  On 11 Feb 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch N0: MOD012M20A ) intramuscularly in the right arm for prophylaxis of covid 19 infection.  On 12 Feb 2021, the patient had tightness in chest and difficulty in breathing. Went to local urgent care and ambulance called to transport her to hospital as was feared a cardiovascular event. Admitted to hospital on 12 Feb 2021 and  discharged on 13 Feb 2021. She had stress test, echo, CT and x-rays all were normal. She followed up with her PCP on 15 Feb 2021 and was told that she might have starting of something like bronchitis. The events caused hospitalization and was serious.  Treatment included  antibiotics and steroid shot and prescribed inhaler.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, Cardiovascular symptom, Chest discomfort, Dyspnea, considered recovered on 13 Feb 2021 and outcome of the event Bronchitis considered recovered on an unknown date.; 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.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram abnormal, X-ray abnormal
Clinical narrative: cardiovascular event; Tightness in chest; Difficulty Breathing; Bronchitis; A Spontaneous report  was received from a health care professional concerning a 79 year old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced Cardiovascular symptom, Chest discomfort, Dyspnea, Bronchitis.  The patient's medical history as provided by the reporter included Neuropathy of feet, elevated Cholesterol, Osteoarthritis, Aortic aneurysm. Concomitant medication included Levothyroxine sodium, Sumatriptan, Rosuvastatin, Piroxicam and Vitamin D  On 11 Feb 2021, prior to the onset of events the patient received first dose of their two planned doses of mRNA-1273 (Batch N0: MOD012M20A ) intramuscularly in the right arm for prophylaxis of covid 19 infection.  On 12 Feb 2021, the patient had tightness in chest and difficulty in breathing. Went to local urgent care and ambulance called to transport her to hospital as was feared a cardiovascular event. Admitted to hospital on 12 Feb 2021 and  discharged on 13 Feb 2021. She had stress test, echo, CT and x-rays all were normal. She followed up with her PCP on 15 Feb 2021 and was told that she might have starting of something like bronchitis. The events caused hospitalization and was serious.  Treatment included  antibiotics and steroid shot and prescribed inhaler.  Action taken with mRNA-1273 in response to the events was unknown.  The outcome of events, Cardiovascular symptom, Chest discomfort, Dyspnea, considered recovered on 13 Feb 2021 and outcome of the event Bronchitis considered recovered on an unknown date.; 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: Liver disorder
Clinical narrative: something wrong with the liver; A spontaneous report was received from a consumer concerning patients of unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and were dying after second shot and something wrong with the liver (liver disorder).  The patients' medical histories were not provided. No relevant concomitant medications were reported.  Dates of vaccination were not reported. The reported heard on the news that "people are dying after the second shot" and apparently one of the patients had something wrong with the liver after getting the shot.  The reporter said the patients received Moderna's mRNA-vaccine.  On an unknown date, the patient experienced the event(s) people are dying after second shot,   No treatment information was provided.  The action taken with the vaccine in response to the events was not applicable.  The cause of death for "one of the patients was had something wrong with the liver".; Reporter's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested; Reported Cause(s) of Death: liver disorder; death unknown cause
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Patient got full blown flu whey used live virus now he doesn't; Initial information was received on 08-Oct-2020 regarding an unsolicited valid social media case from a consumer via social media.  This case involves male patient who experienced full blown flu (whey used live virus now he doesn't) (influenza), while he received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, past vaccinations, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer, lot number and expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious patient full blown flu (whey used live virus now he doesn't) (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Face injury, Fall, Head injury, Oxygen saturation
Clinical narrative: About 15 min after receiving the vaccine, patient started to stand after sitting in a chair for 10 min and fainted, falling with his head hitting the ground.  He sustained a laceration above one eyebrow that required stitches to be placed.  He was assessed by a medic on site, vitals taken, and oxygen administered.  His blood sugar was in the 70s.  Patient admitted to fear of needles, not eating much all day, and hx of similar episode after receiving an IM injection of a muscle relaxant about 10 yrs ago.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Physical examination, Skin laceration, Syncope, Vital signs measurement
Clinical narrative: About 15 min after receiving the vaccine, patient started to stand after sitting in a chair for 10 min and fainted, falling with his head hitting the ground.  He sustained a laceration above one eyebrow that required stitches to be placed.  He was assessed by a medic on site, vitals taken, and oxygen administered.  His blood sugar was in the 70s.  Patient admitted to fear of needles, not eating much all day, and hx of similar episode after receiving an IM injection of a muscle relaxant about 10 yrs ago.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Dizziness, Hyperhidrosis
Clinical narrative: cough, dizziness, and diaphoretic; transported to ED
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Feeling abnormal, Paraesthesia, Tongue disorder
Clinical narrative: Respiratory. Labored breathing, felt strange, little tingling in hands, tongue felt thick a little layet
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain, Pyrexia, Rash
Clinical narrative: Fever (101.5 F), body aches, headaches, rash, lethargy. Fever lasted 3 days, headaches and lethargy are  continuing.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Hot flush, Nausea
Clinical narrative: Hot flash 5 minutes after shot. Due date april 26th 2021. No adverse reactions to baby known at this time. Nausea 40 minutes after shot
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site induration, Injection site rash, Pain in extremity
Clinical narrative: My left arm was sore the day after vaccination but soreness went away quickly. 8 days after vaccination, a rash formed on my left bicep about the size of a quarter. Today, (Day 9 post vaccination), the rash is about the sized of a plum and is very hot to the touch.  I have not sough any medical treatment at this time. I read about Covid arm but am reporting these symptoms as the rash is on the same arm where i received the vaccination but not the same location.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness
Clinical narrative: At about four weeks after my second (Moderna) Covid vaccine I started having dizziness and light-headedness on and off which has persisted. It causes balance issues which I have never had before. I am a retired Nurse Practitioner.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Blood glucose decreased, Cerebral atrophy, Chronic inflammatory demyelinating polyradiculoneuropathy, Computerised tomogram normal
Clinical narrative: Patient  had vaccine 1/28/2021. Two days later developed left sided abdominal pain that was severe enough to warrant multiple ER visits, one admission, multiple negative tests including but not limited to CT scan and endoscopy. He lost 30 pounds. In the beginning of March he began noticing tingling and numbness in arms and legs which has progressed to paralysis of his bilateral lower extremities. He is now hospitalized for same and has a working diagnosis of CIDP (chronic inflammatory demyelinating polyneuropathy).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Culture negative, Cytology normal, Diplegia, Endoscopy normal, Hypoaesthesia
Clinical narrative: Patient  had vaccine 1/28/2021. Two days later developed left sided abdominal pain that was severe enough to warrant multiple ER visits, one admission, multiple negative tests including but not limited to CT scan and endoscopy. He lost 30 pounds. In the beginning of March he began noticing tingling and numbness in arms and legs which has progressed to paralysis of his bilateral lower extremities. He is now hospitalized for same and has a working diagnosis of CIDP (chronic inflammatory demyelinating polyneuropathy).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Lumbar puncture, Magnetic resonance imaging head, Magnetic resonance imaging spinal abnormal, Paraesthesia, Protein total increased
Clinical narrative: Patient  had vaccine 1/28/2021. Two days later developed left sided abdominal pain that was severe enough to warrant multiple ER visits, one admission, multiple negative tests including but not limited to CT scan and endoscopy. He lost 30 pounds. In the beginning of March he began noticing tingling and numbness in arms and legs which has progressed to paralysis of his bilateral lower extremities. He is now hospitalized for same and has a working diagnosis of CIDP (chronic inflammatory demyelinating polyneuropathy).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Spinal flattening, Spinal stenosis, Weight decreased, White blood cell count normal
Clinical narrative: Patient  had vaccine 1/28/2021. Two days later developed left sided abdominal pain that was severe enough to warrant multiple ER visits, one admission, multiple negative tests including but not limited to CT scan and endoscopy. He lost 30 pounds. In the beginning of March he began noticing tingling and numbness in arms and legs which has progressed to paralysis of his bilateral lower extremities. He is now hospitalized for same and has a working diagnosis of CIDP (chronic inflammatory demyelinating polyneuropathy).
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram abnormal, Lip swelling, Moaning, Sinus tachycardia
Clinical narrative: PT WAS AT CHCKOUT. PT LEANED OVER GRASPING HIS CHEST. PT PLACED INTO OBSERVATION CHAIR AND IMMEDIATELY BROUGHT TO OBSERVATION ROOM WHERE HE WAS ASSESED BY STAFF NURSES, MEDICAL PROVIDER, EMT'S. . PT MASK REMOVED UPPER LUP SWOLLEN. AIRWAY PATENT, NO S/S OF RESPIRATORY DISTRESS NOTED. PT GRASPING CHEST, MOANING IN PAIN. 12 LEAD EKG PERFORMED SINUS TACH. 18 GUAGE SL PLACED TO RT HAND, ATTEMPT X 1 PT TOLERATED WELL.  BENADRYL 50MG IM X 1 DETHAMEXASONE 10MG IMX 1 CHEWABLE ASPIRIN 324MG PO X1 12:45 PT HR TACHY AT 132, RR20,  B/P136/82 12:49 PT HR 125, RR20, B/P 138/88 12:54 PT HR 119, RR 19, BP 159/83 1300: RESCUE ARRIVED, CARE TAKEN OVER FROM THERE.  PT REMAINS STATUS REMAINS FAIR AND STABLE UPN D/C
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: The site of injection was swollen, red and tender for a couple days.  Then it stayed red and itchy until March 23.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Dysgeusia, Headache, Pain
Clinical narrative: Headache, fever, sore body, weakness, strange taste in my mouth after eating, light headed ness
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Headache, fever, sore body, weakness, strange taste in my mouth after eating, light headed ness
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Pain in extremity, Urticaria
Clinical narrative: First dose 3/2/21 chills and sore arm.  Second dose 3/23/21 sore arm, achy muscles and joints, headache, hives Allergist Dr. recommended Allegra
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Contusion, Laboratory test
Clinical narrative: Spontaneous bruising of both legs, back and hip soreness and pain.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site hypoaesthesia, Injection site pain, Injection site pruritus
Clinical narrative: On 3/23/2021 at 9pm my injection site started itching furiously and I noticed that there was a painful, red, raised lesion where I received my vaccination. Right after I got the vaccine, my site was numb and stayed bruised for a week, but the bruise, while noted, wasn?t anything alarming or worth reporting. However, the delayed itchy, red skin lesion I thought should be reported to you since it is known as a rare skin reaction that may not be as rare as it is being released in the news in people with a known history eczema.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site reaction, Injection site swelling, Skin lesion
Clinical narrative: On 3/23/2021 at 9pm my injection site started itching furiously and I noticed that there was a painful, red, raised lesion where I received my vaccination. Right after I got the vaccine, my site was numb and stayed bruised for a week, but the bruise, while noted, wasn?t anything alarming or worth reporting. However, the delayed itchy, red skin lesion I thought should be reported to you since it is known as a rare skin reaction that may not be as rare as it is being released in the news in people with a known history eczema.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Angioedema, Dizziness, Dyspnoea, Hypoaesthesia oral, Lip swelling
Clinical narrative: Developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone Pepcid, and Allegra, after about 2 hours of observation in ED with gradual decrease in swelling of her lips. No shortness of breath at discharge.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral
Clinical narrative: Developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone Pepcid, and Allegra, after about 2 hours of observation in ED with gradual decrease in swelling of her lips. No shortness of breath at discharge.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia oral, Throat tightness
Clinical narrative: Developed lip swelling, mouth numbness/tingling, dizziness, and difficulty breathing within 30 minutes of receiving the vaccine. In light of the lip swelling (angioedema), she was given Benadryl and epipen at the clinic and transferred to ED for further evaluation. She received Solumedrol and Pepcid. Discharged on prednisone Pepcid, and Allegra, after about 2 hours of observation in ED with gradual decrease in swelling of her lips. No shortness of breath at discharge.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash
Clinical narrative: Pt reports reaction started several days after the injection.  She reported a rash starting around right hip and traveling up her torso.  It then started around right wrist and moved up arm to vaccine site area.  Pt had pictures of injection site as well as the  swelling of her arm.   Site was a deep red, that appeared to be width of her upper arm,  with a darker red edge.  Swelling of arm visible in picture also. She reported calling an office and was told to take Benadryl for several days.  Seven days after injection she called her PCP and a Medrol Dose Pak was prescribed.  Unknown as to whether she was seen in office or not.  We were not notified of reaction until pt came for 2nd Covid injection.  Pt was advised to seek advise of PCP as to whether she should get vaccine or not, and return to vaccine site if PCP was in agreement to get 2nd dose.  Pt did not return.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test normal, Computerised tomogram head, Computerised tomogram neck, Dizziness, Headache
Clinical narrative: I was doing my normal morning jog four days after the 1st vac and a few block in I got a sudden, staggering, lighting-bolt-like headache for about 20 seconds. Nausea. Dizzy. then the headache moved to a painful ache that spread across the back of my head. As that happened, deep in my neck where the spine meets the scull there was a hobbling pain/cramp/spasm. I went to the ER.