chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin E increased, Blood magnesium normal, Breast enlargement, C-reactive protein increased, C-reactive protein normal
Clinical narrative: Injection site pain persisted, without fading, from 4/29/21 to present.  R arm. Elevated sed rate >50 (details in item #19) 7/19/21 - developed severe nerve pain (C8 dermatome - dorsal pain from R scapula to 4th and 5th digit).   Small rash on ventral surface, 2-3" below R collarbone without pain but some itching.  Assumed to be normal breakouts from brassiere friction (I have macromastia) 8/2/21 - diagnosed as shingles with ventral small rash (7-10 healing pustules).  Rx'd valtrex 1 g tid x 14 d.  Severe nerve pain in C8/ulnar nerve that had worsened since  7/19/21 began to fade.  Some loss of grip strength when holding a fork.  Can still type. 8/9/21 - pain fading but now with weakness in 4th and 5th digits of R hand, further loss of grip strength and now some numbing.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count normal, Grip strength decreased, Herpes zoster, Hypoaesthesia, Implant site pustules
Clinical narrative: Injection site pain persisted, without fading, from 4/29/21 to present.  R arm. Elevated sed rate >50 (details in item #19) 7/19/21 - developed severe nerve pain (C8 dermatome - dorsal pain from R scapula to 4th and 5th digit).   Small rash on ventral surface, 2-3" below R collarbone without pain but some itching.  Assumed to be normal breakouts from brassiere friction (I have macromastia) 8/2/21 - diagnosed as shingles with ventral small rash (7-10 healing pustules).  Rx'd valtrex 1 g tid x 14 d.  Severe nerve pain in C8/ulnar nerve that had worsened since  7/19/21 began to fade.  Some loss of grip strength when holding a fork.  Can still type. 8/9/21 - pain fading but now with weakness in 4th and 5th digits of R hand, further loss of grip strength and now some numbing.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Metabolic function test normal, Muscular weakness, Neuralgia, Pruritus
Clinical narrative: Injection site pain persisted, without fading, from 4/29/21 to present.  R arm. Elevated sed rate >50 (details in item #19) 7/19/21 - developed severe nerve pain (C8 dermatome - dorsal pain from R scapula to 4th and 5th digit).   Small rash on ventral surface, 2-3" below R collarbone without pain but some itching.  Assumed to be normal breakouts from brassiere friction (I have macromastia) 8/2/21 - diagnosed as shingles with ventral small rash (7-10 healing pustules).  Rx'd valtrex 1 g tid x 14 d.  Severe nerve pain in C8/ulnar nerve that had worsened since  7/19/21 began to fade.  Some loss of grip strength when holding a fork.  Can still type. 8/9/21 - pain fading but now with weakness in 4th and 5th digits of R hand, further loss of grip strength and now some numbing.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Red blood cell sedimentation rate increased, Red blood cell sedimentation rate normal
Clinical narrative: Injection site pain persisted, without fading, from 4/29/21 to present.  R arm. Elevated sed rate >50 (details in item #19) 7/19/21 - developed severe nerve pain (C8 dermatome - dorsal pain from R scapula to 4th and 5th digit).   Small rash on ventral surface, 2-3" below R collarbone without pain but some itching.  Assumed to be normal breakouts from brassiere friction (I have macromastia) 8/2/21 - diagnosed as shingles with ventral small rash (7-10 healing pustules).  Rx'd valtrex 1 g tid x 14 d.  Severe nerve pain in C8/ulnar nerve that had worsened since  7/19/21 began to fade.  Some loss of grip strength when holding a fork.  Can still type. 8/9/21 - pain fading but now with weakness in 4th and 5th digits of R hand, further loss of grip strength and now some numbing.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Neck mass, Oedema peripheral
Clinical narrative: My armpit is swollen(right side), and there is a lump on my neck (right side)
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Asthma, Dyspnoea
Clinical narrative: I have been having shortness of breath weakness asthma like symptoms
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Ventricular extrasystoles
Clinical narrative: Premature Ventricular Contractions
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Limb discomfort
Clinical narrative: Dizziness, Light-headedness, Fatigue, heaviness in legs, all increasing in severity each day. No treatment sought yet at this time.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: developed COVID disease 8/3/21
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Contraception, Heavy menstrual bleeding, Intermenstrual bleeding, Polymenorrhoea
Clinical narrative: Second dose was April 7, 2021.  Had menstruations April 12, for about 7 days.  April 24 took dose of Take Action Levonorgestrel 1.5mg., and started menstruations/spotting April 30- May 10. Had menstruations again May 17-May 23.  May 29 took another does of Take Action Levonorgestrel 1.5mg., Had menstruations for 2 weeks,  June 4-June 19th, with heavy flow and discharge on June 15th only, and with upset stomach last day.  Normal period July 17-24.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vaginal discharge
Clinical narrative: Second dose was April 7, 2021.  Had menstruations April 12, for about 7 days.  April 24 took dose of Take Action Levonorgestrel 1.5mg., and started menstruations/spotting April 30- May 10. Had menstruations again May 17-May 23.  May 29 took another does of Take Action Levonorgestrel 1.5mg., Had menstruations for 2 weeks,  June 4-June 19th, with heavy flow and discharge on June 15th only, and with upset stomach last day.  Normal period July 17-24.
Age: 1.0
Sex: M
Vaccine: MMR, MMR
Symptoms: Autism spectrum disorder
Clinical narrative: Autism
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Heavy menstrual bleeding, Menstruation delayed
Clinical narrative: Although I felt super tired the day I got the shot, I experienced few other side effects until a month later. I've just had one of the worst periods of my life - the headache was unbearable and the cramps were near crippling. My period was a week late. Although these are not life-threatening side effects, they did handicap me for an entire day to the point where all I could do was sit on the couch; this is highly unusual for my menstrual cycle, so I thought I'd report it.   I realize that women's cycles are hard to analyze because of stress, diet, and other irregularities that make it difficult to pinpoint sudden changes; but my cycles have been mostly predictable to the point where this is memorable in a long line of unmemorable periods. I was not going through any extra stress (physical or emotional) in the weeks before my period, had not eaten anything strange, met new people, or even had sex in the month prior to my period.   The first three days of my 7-day cycle (which is now complete) were utterly devastating. The headache started as a migraine, which is not unusual for me, but it progressed to my ENTIRE HEAD and down to the top of my shoulders (double-sided migraine, which I've never had before). My cramps were powerful, relentless, and left me gasping for breath. My flow was extra heavy and lasted. much longer than normal.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Muscle spasms
Clinical narrative: Although I felt super tired the day I got the shot, I experienced few other side effects until a month later. I've just had one of the worst periods of my life - the headache was unbearable and the cramps were near crippling. My period was a week late. Although these are not life-threatening side effects, they did handicap me for an entire day to the point where all I could do was sit on the couch; this is highly unusual for my menstrual cycle, so I thought I'd report it.   I realize that women's cycles are hard to analyze because of stress, diet, and other irregularities that make it difficult to pinpoint sudden changes; but my cycles have been mostly predictable to the point where this is memorable in a long line of unmemorable periods. I was not going through any extra stress (physical or emotional) in the weeks before my period, had not eaten anything strange, met new people, or even had sex in the month prior to my period.   The first three days of my 7-day cycle (which is now complete) were utterly devastating. The headache started as a migraine, which is not unusual for me, but it progressed to my ENTIRE HEAD and down to the top of my shoulders (double-sided migraine, which I've never had before). My cramps were powerful, relentless, and left me gasping for breath. My flow was extra heavy and lasted. much longer than normal.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymp nobe under left arm pit was enlarged and  painful for 4 days
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Depression, Mood altered, Self-injurious ideation
Clinical narrative: severe depression, gloom, anxiety, including unsafe thoughts
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Epistaxis, Heavy menstrual bleeding, Platelet count decreased
Clinical narrative: Daily nose bleeds, generalized bruising, and heavy menstrual cycle
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Brain natriuretic peptide, Chest pain, Dyspnoea, Troponin increased
Clinical narrative: chest pain, shortness of breath, elevated troponin and BNP values
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in armpit
Age: 15.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Rash
Clinical narrative: While at a UVAX event, a client was scheduled to have his second dose of the Pfizer vaccine. While interviewing the client, he reported experiencing a linear rash on the abdominal area and slight difficulty breathing during the first dose of the Pfizer vaccine on 7/16/21. We edited our records, gave the 2nd dose of the vaccine, and monitored the patient for 30 minutes for any anaphylactic reactions. The patient did not report having any allergic signs and symptoms during and after the 30 minute monitor time. The patient mother verbalized understanding instructions.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Vaccination site rash, Vaccination site warmth
Clinical narrative: Pt had first Moderna covid vaccine on 7/29/2021 with no initial reaction. Since 8/5/2021 with the beginning of symptoms., pt has noticed a erythematous rash around possible vaccine site of left deltoid region. Not pruritic. Little more than 2 cm in height and width. It can feel warm at times.   Never had a reaction to any vaccine prior  COVID ARM
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Balance disorder, Dizziness, Electrocardiogram, Flushing
Clinical narrative: As soon as vaccine given by the nurse I had a strong smell of aluminum in my nose (masked) and my face, chest, hands, and underarms felt very flushed. My heart rate jumped to 150 then dropped into 80s-110s, accompanied by a sense of panic, dizziness, and blurry vision. My chest, underarms, and forehead burned exceptionally bad like on fire, alternating between hot fire and cold fire.  My pulse rate stabilized within a half hour.  I had a meeting with the doctor before leaving. I was told to go home, take Benadryl, relax, and to go to the ER if I had throat issues.   I returned to feeling very sick on my short five to ten minutes ride home. At home the burning intensified, the dizziness  increased, my pulse rate was spiking to the 140s then dropping to 70s-80s. My throat started to hurt. I took Benadryl and swallowing was hard and painful. That combined with the other symptoms I decided to go to the ER.  In triage I had a very hard time sitting still for an EKG because my nerves were jumping so bad, especially in my legs. As I understand my oxygen rate was okay and my pulse was fast. I was told the Benadryl probably had kicked in to help.   I had about a two to three hour wait at the ER before I was taken back. As long as I stayed very still I felt mostly okay except being very hot. If I tried to walk such as a short distance to the restroom I has very dizzy and had bad balance.   At one point in the waiting, having been sitting still, I thought I was okay to go home. But as soon as I got outside I was very dizzy and had to sit down on the ground. The ER intake staff came and got me with a wheelchair.   One I was taken to a room in the ER I was feeling better than I did two-three hours before, but was still yo-yoing with dizziness, burning pain in my chest and back. It still felt like my heart was racing some.  The doctor prescribed a steroid allergy medicine to treat allergies. After about one hour I started feeling a lot better. The burning sensation went away and I was able to walk without being dizzy. I still felt sick and my chest felt like it was very severely bruised.   After about five hours in the ER I started getting very anxious, overhearing the covid and trauma patients. I was treated for that then discharged.  Once home by about 9:00 pm I felt very achy and bruised in some places, but overall better. At about midnight the chest pain and burning returned and I had a small headache. I took more Benadryl.   It is now after 2:30 am and my chest is still cold and burning and the nerves in my legs are very jumpy. I have low to moderate pain in my muscles and joints, especially jaw, wrists, and hips.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased, Malaise, Myalgia, Oropharyngeal pain, Pain in jaw
Clinical narrative: As soon as vaccine given by the nurse I had a strong smell of aluminum in my nose (masked) and my face, chest, hands, and underarms felt very flushed. My heart rate jumped to 150 then dropped into 80s-110s, accompanied by a sense of panic, dizziness, and blurry vision. My chest, underarms, and forehead burned exceptionally bad like on fire, alternating between hot fire and cold fire.  My pulse rate stabilized within a half hour.  I had a meeting with the doctor before leaving. I was told to go home, take Benadryl, relax, and to go to the ER if I had throat issues.   I returned to feeling very sick on my short five to ten minutes ride home. At home the burning intensified, the dizziness  increased, my pulse rate was spiking to the 140s then dropping to 70s-80s. My throat started to hurt. I took Benadryl and swallowing was hard and painful. That combined with the other symptoms I decided to go to the ER.  In triage I had a very hard time sitting still for an EKG because my nerves were jumping so bad, especially in my legs. As I understand my oxygen rate was okay and my pulse was fast. I was told the Benadryl probably had kicked in to help.   I had about a two to three hour wait at the ER before I was taken back. As long as I stayed very still I felt mostly okay except being very hot. If I tried to walk such as a short distance to the restroom I has very dizzy and had bad balance.   At one point in the waiting, having been sitting still, I thought I was okay to go home. But as soon as I got outside I was very dizzy and had to sit down on the ground. The ER intake staff came and got me with a wheelchair.   One I was taken to a room in the ER I was feeling better than I did two-three hours before, but was still yo-yoing with dizziness, burning pain in my chest and back. It still felt like my heart was racing some.  The doctor prescribed a steroid allergy medicine to treat allergies. After about one hour I started feeling a lot better. The burning sensation went away and I was able to walk without being dizzy. I still felt sick and my chest felt like it was very severely bruised.   After about five hours in the ER I started getting very anxious, overhearing the covid and trauma patients. I was treated for that then discharged.  Once home by about 9:00 pm I felt very achy and bruised in some places, but overall better. At about midnight the chest pain and burning returned and I had a small headache. I took more Benadryl.   It is now after 2:30 am and my chest is still cold and burning and the nerves in my legs are very jumpy. I have low to moderate pain in my muscles and joints, especially jaw, wrists, and hips.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Parosmia, Vision blurred
Clinical narrative: As soon as vaccine given by the nurse I had a strong smell of aluminum in my nose (masked) and my face, chest, hands, and underarms felt very flushed. My heart rate jumped to 150 then dropped into 80s-110s, accompanied by a sense of panic, dizziness, and blurry vision. My chest, underarms, and forehead burned exceptionally bad like on fire, alternating between hot fire and cold fire.  My pulse rate stabilized within a half hour.  I had a meeting with the doctor before leaving. I was told to go home, take Benadryl, relax, and to go to the ER if I had throat issues.   I returned to feeling very sick on my short five to ten minutes ride home. At home the burning intensified, the dizziness  increased, my pulse rate was spiking to the 140s then dropping to 70s-80s. My throat started to hurt. I took Benadryl and swallowing was hard and painful. That combined with the other symptoms I decided to go to the ER.  In triage I had a very hard time sitting still for an EKG because my nerves were jumping so bad, especially in my legs. As I understand my oxygen rate was okay and my pulse was fast. I was told the Benadryl probably had kicked in to help.   I had about a two to three hour wait at the ER before I was taken back. As long as I stayed very still I felt mostly okay except being very hot. If I tried to walk such as a short distance to the restroom I has very dizzy and had bad balance.   At one point in the waiting, having been sitting still, I thought I was okay to go home. But as soon as I got outside I was very dizzy and had to sit down on the ground. The ER intake staff came and got me with a wheelchair.   One I was taken to a room in the ER I was feeling better than I did two-three hours before, but was still yo-yoing with dizziness, burning pain in my chest and back. It still felt like my heart was racing some.  The doctor prescribed a steroid allergy medicine to treat allergies. After about one hour I started feeling a lot better. The burning sensation went away and I was able to walk without being dizzy. I still felt sick and my chest felt like it was very severely bruised.   After about five hours in the ER I started getting very anxious, overhearing the covid and trauma patients. I was treated for that then discharged.  Once home by about 9:00 pm I felt very achy and bruised in some places, but overall better. At about midnight the chest pain and burning returned and I had a small headache. I took more Benadryl.   It is now after 2:30 am and my chest is still cold and burning and the nerves in my legs are very jumpy. I have low to moderate pain in my muscles and joints, especially jaw, wrists, and hips.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, itching, pain and redness at the injection site within an hour of injection. Developed a nodule in left deltoid lasting more than 10 days. Swelling is decreasing but still present at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Erythema, Injection site pruritus, Vaccination site induration, Vaccination site warmth
Clinical narrative: Hardness; Warm to touch; Redness on top and underneath her arm the size of grapefruit; Itching at the injection site; Soreness from the elbow to shoulder; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION, VACCINATION SITE WARMTH, ERYTHEMA (Redness on top and underneath her arm the size of grapefruit), INJECTION SITE PRURITUS (Itching) and ARTHRALGIA (Soreness from the elbow to shoulder) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE INDURATION, VACCINATION SITE WARMTH, ERYTHEMA (Redness on top and underneath her arm the size of grapefruit), INJECTION SITE PRURITUS (Itching), and ARTHRALGIA (Soreness from the elbow to shoulder). At the time of the report, VACCINATION SITE INDURATION, VACCINATION SITE WARMTH, ERYTHEMA (Redness on top and underneath her arm the size of grapefruit), INJECTION SITE PRURITUS (Itching) and ARTHRALGIA (Soreness from the elbow to shoulder) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.  No concomitant medication was provided.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: swollen lymph node on his left arm and left armpit; This spontaneous case was reported by a consumer and describes the occurrence of in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment included paracetamol.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: a welt on the injection site that is warm to the touch; a welt on the injection site that is about the size of a half dollar; a welt on the injection site that is itchy; a welt on the injection site that is red; sore at the sight of injection for 3-4 days; chills; low grade temperature of 99.1; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH, VACCINATION SITE URTICARIA, VACCINATION SITE PRURITUS, VACCINATION SITE ERYTHEMA (a welt on the injection site that is red) and VACCINATION SITE PAIN (sore at the sight of injection for 3-4 days) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included ACIPHEX, MULTIVITAMINS, VITAMIN D3, PROBIOTICS, VITAMIN B12, ELDERBERRY, and FLONASE ALLERGY RELIEF for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN, CHILLS, and PYREXIA. On 19-Jan-2021, the patient experienced VACCINATION SITE WARMTH, VACCINATION SITE URTICARIA, VACCINATION SITE PRURITUS, and VACCINATION SITE ERYTHEMA. At the time of the report, VACCINATION SITE WARMTH, VACCINATION SITE URTICARIA, VACCINATION SITE PRURITUS, and VACCINATION SITE ERYTHEMA outcome was unknown and VACCINATION SITE PAIN, CHILLS, and PYREXIA had resolved.        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.   Treatment details were not reported by the reporter.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site urticaria, Vaccination site warmth
Clinical narrative: a welt on the injection site that is warm to the touch; a welt on the injection site that is about the size of a half dollar; a welt on the injection site that is itchy; a welt on the injection site that is red; sore at the sight of injection for 3-4 days; chills; low grade temperature of 99.1; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH, VACCINATION SITE URTICARIA, VACCINATION SITE PRURITUS, VACCINATION SITE ERYTHEMA (a welt on the injection site that is red) and VACCINATION SITE PAIN (sore at the sight of injection for 3-4 days) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No reported medical history.  Concomitant products included ACIPHEX, MULTIVITAMINS, VITAMIN D3, PROBIOTICS, VITAMIN B12, ELDERBERRY, and FLONASE ALLERGY RELIEF for an unknown indication.    On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN, CHILLS, and PYREXIA. On 19-Jan-2021, the patient experienced VACCINATION SITE WARMTH, VACCINATION SITE URTICARIA, VACCINATION SITE PRURITUS, and VACCINATION SITE ERYTHEMA. At the time of the report, VACCINATION SITE WARMTH, VACCINATION SITE URTICARIA, VACCINATION SITE PRURITUS, and VACCINATION SITE ERYTHEMA outcome was unknown and VACCINATION SITE PAIN, CHILLS, and PYREXIA had resolved.        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.   Treatment details were not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swelling around injection site; redness around injection site; This spontaneous case was reported by a pharmacist and describes the occurrence of INJECTION SITE SWELLING and INJECTION SITE ERYTHEMA (redness around injection site) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING and INJECTION SITE ERYTHEMA (redness around injection site). At the time of the report, INJECTION SITE SWELLING and INJECTION SITE ERYTHEMA (redness around injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.  Concomitant product use was not provided by the reporter. No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Gastrooesophageal reflux disease, Nausea, Vomiting
Clinical narrative: felt like acid reflux; nausea; vomiting; felt pain between shoulder blades; A Spontaneous report was received from consumer concerning a 66-year-old female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced acid reflux nausea then vomited, felt pain between shoulder blades.  The patient's medical history and concomitant medical history reported unknown.  On 20 Jan 2021 at 01:30 PM, the patient received their one dose of the two planned doses of COVID-19 Vaccine (mRNA-1273) intramuscularly in the right arm for prophylaxis of COVID-19 infection and experienced acid reflux and on 21 Jan 2021 felt nausea then vomited and pain Between Shoulder Blades.  No laboratory tests were provided.   No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event is unknown. Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Pain, Poor quality sleep
Clinical narrative: Didn't feel good; started running fever, its spiking up to 101 deg F; Headache; Shooting pain above ears; Felt achy; Didn't sleep well; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA, MALAISE, PYREXIA (started running fever, its spiking up to 101 deg F), POOR QUALITY SLEEP, and HEADACHE in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO medical history information was reported.  Concomitant products included LEVOTHYROXINE and SIMVASTATIN for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced POOR QUALITY SLEEP. On 19-Jan-2021, the patient experienced MYALGIA. On 20-Jan-2021, the patient experienced MALAISE, PYREXIA, HEADACHE, and PAIN (Shooting pain above ears). The patient was treated with TYLENOL at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA (Felt achy), MALAISE, PYREXIA, POOR QUALITY SLEEP (Didn't sleep well), HEADACHE, and PAIN (Shooting pain above ears) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Pyrexia: 101 Degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was received via an unknown source (no reference has been entered for a health authority) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA, MALAISE, PYREXIA, POOR QUALITY SLEEP, and HEADACHE in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO medical history information was reported.  Concomitant products included LEVOTHYROXINE and SIMVASTATIN for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced POOR QUALITY SLEEP (Didn't sleep well). On 19-Jan-2021, the patient experienced MYALGIA (Felt achy). On 20-Jan-2021, the patient experienced MALAISE, PYREXIA (started running fever, its spiking up to 101 deg F), HEADACHE and PAIN (Shooting pain above ears). The patient was treated with TYLENOL at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA, MALAISE, PYREXIA, POOR QUALITY SLEEP, HEADACHE, and PAIN (Shooting pain above ears) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Pyrexia: 101 Degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Didn't feel good; started running fever, its spiking up to 101 deg F; Headache; Shooting pain above ears; Felt achy; Didn't sleep well; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA, MALAISE, PYREXIA (started running fever, its spiking up to 101 deg F), POOR QUALITY SLEEP, and HEADACHE in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO medical history information was reported.  Concomitant products included LEVOTHYROXINE and SIMVASTATIN for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced POOR QUALITY SLEEP. On 19-Jan-2021, the patient experienced MYALGIA. On 20-Jan-2021, the patient experienced MALAISE, PYREXIA, HEADACHE, and PAIN (Shooting pain above ears). The patient was treated with TYLENOL at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA (Felt achy), MALAISE, PYREXIA, POOR QUALITY SLEEP (Didn't sleep well), HEADACHE, and PAIN (Shooting pain above ears) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Pyrexia: 101 Degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was received via an unknown source (no reference has been entered for a health authority) on 22-Jan-2021 and was forwarded to Moderna on 22-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA, MALAISE, PYREXIA, POOR QUALITY SLEEP, and HEADACHE in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     NO medical history information was reported.  Concomitant products included LEVOTHYROXINE and SIMVASTATIN for an unknown indication.    On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Jan-2021, the patient experienced POOR QUALITY SLEEP (Didn't sleep well). On 19-Jan-2021, the patient experienced MYALGIA (Felt achy). On 20-Jan-2021, the patient experienced MALAISE, PYREXIA (started running fever, its spiking up to 101 deg F), HEADACHE and PAIN (Shooting pain above ears). The patient was treated with TYLENOL at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. At the time of the report, MYALGIA, MALAISE, PYREXIA, POOR QUALITY SLEEP, HEADACHE, and PAIN (Shooting pain above ears) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Jan-2021, Pyrexia: 101 Degree F.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Flatulence
Clinical narrative: Stomach cramps and loose stool, fatigue. Still cramps and gassiness continue
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood test, Computerised tomogram, Decreased appetite, Dizziness
Clinical narrative: 18 days after 2nd shot- Polymyalgia rbeumatica attack, extreme muscle weakness, dizziness 2 trips to the ER, in bed for 30 days, too weak to get off of the sofa or eat much for 30 days. I was very "unwell" had to hire someone to stay in my home with me in the mornings 8am until 12 noon. I lost 20 lbs, both arms feel very heavy with a very stiff neck, trembling hands and anxiety due to immobility.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Immobile, Limb discomfort, Loss of personal independence in daily activities, Malaise, Mobility decreased
Clinical narrative: 18 days after 2nd shot- Polymyalgia rbeumatica attack, extreme muscle weakness, dizziness 2 trips to the ER, in bed for 30 days, too weak to get off of the sofa or eat much for 30 days. I was very "unwell" had to hire someone to stay in my home with me in the mornings 8am until 12 noon. I lost 20 lbs, both arms feel very heavy with a very stiff neck, trembling hands and anxiety due to immobility.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Muscular weakness, Musculoskeletal stiffness, Polymyalgia rheumatica, Tremor, Weight decreased
Clinical narrative: 18 days after 2nd shot- Polymyalgia rbeumatica attack, extreme muscle weakness, dizziness 2 trips to the ER, in bed for 30 days, too weak to get off of the sofa or eat much for 30 days. I was very "unwell" had to hire someone to stay in my home with me in the mornings 8am until 12 noon. I lost 20 lbs, both arms feel very heavy with a very stiff neck, trembling hands and anxiety due to immobility.
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site erythema, Pruritus
Clinical narrative: injection site redness 4-5 inches; itchiness; feels warm; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site redness 4-5 inches), PRURITUS (itchiness) and FEELING HOT in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included Pain since an unknown date. Concomitant products included MINERALS, VITAMINS, CALCIUM, CRANBERRY, and TYLENOL for an unknown indication.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site redness 4-5 inches), PRURITUS (itchiness) and FEELING HOT. At the time of the report, INJECTION SITE ERYTHEMA (injection site redness 4-5 inches), PRURITUS (itchiness) and FEELING HOT outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 23-Jan-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE ERYTHEMA (injection site redness 4-5 inches), PRURITUS (itchiness) and FEELING HOT in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization.     The patient's past medical history included Pain since an unknown date. Concomitant products included MINERALS, VITAMINS, CALCIUM, CRANBERRY, and TYLENOL for an unknown indication.    On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (injection site redness 4-5 inches), PRURITUS (itchiness) and FEELING HOT. At the time of the report, INJECTION SITE ERYTHEMA (injection site redness 4-5 inches), PRURITUS (itchiness) and FEELING HOT outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment details were reported.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Platelet count, Platelet count decreased, Vaccination site pain
Clinical narrative: Platelets dropped; Could not get out of bed; Arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PLATELET COUNT DECREASED, FATIGUE (Could not get out of bed), and VACCINATION SITE PAIN in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     The patient's past medical history included Platelets increased since an unknown date. Concurrent medical conditions included Platelets decreased. Concomitant products included HYDROXYUREA for Platelet count low, VITAMIN D, VITAMIN B COMPLEX, PRESERVISION AREDS 2, BABY ASPIRIN, and ATORVASTATIN for an unknown indication.    In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PLATELET COUNT DECREASED, FATIGUE (Could not get out of bed), and VACCINATION SITE PAIN. At the time of the report, PLATELET COUNT DECREASED, FATIGUE (Could not get out of bed), and VACCINATION SITE PAIN outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Platelet count: 406.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination.     Concurrent medical conditions included Anxiety depression. Concomitant products included PRENATAL MULTIVITAMIN + DHA for Pregnancy, ZOLOFT for an unknown indication.    On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was in August 2020 and the estimated date of delivery was 10-May-2021. On 01-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  ninth month of the pregnancy.  On 01-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications also included Iron supplement. No treatment information was provided. Previous pregnancy end date was on 28 Apr 2021 resulted into live birth.   Most recent FOLLOW-UP information incorporated above includes: On 11-Feb-2021: Follow up received and added concomitant medications.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Chills, Decreased appetite, Headache
Clinical narrative: Low Grade Fever/ 100F and lower; Bad Headache/ Intense headache varying in intensity; Chills off and on throughout day; Lack of appetite; weakness; Nausea/ Intense nausea. One instance of vomit; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE, ASTHENIA (weakness), NAUSEA, PYREXIA (Low Grade Fever / 100F and lower), and HEADACHE (Intense headache varying in intensity) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included B-12 and VITAMIN D 2000 for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced DECREASED APPETITE, ASTHENIA (weakness), NAUSEA, HEADACHE (Intense headache varying in intensity), and CHILLS. On an unknown date, the patient experienced PYREXIA (Low Grade Fever/ 100F and lower). At the time of the report, DECREASED APPETITE, ASTHENIA (weakness), NAUSEA, PYREXIA (Low Grade Fever/ 100F and lower), HEADACHE (Intense headache varying in intensity), and CHILLS outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 100f (normal) 100F.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was considered to be not applicable.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Patient demographics, lab data, and concomitant medications were updated. Two events were added (chills and loss of appetite). On 19-Apr-2021: additional information received on 19-APR-2021 and does not contain any new information
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Low Grade Fever/ 100F and lower; Bad Headache/ Intense headache varying in intensity; Chills off and on throughout day; Lack of appetite; weakness; Nausea/ Intense nausea. One instance of vomit; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE, ASTHENIA (weakness), NAUSEA, PYREXIA (Low Grade Fever / 100F and lower), and HEADACHE (Intense headache varying in intensity) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included B-12 and VITAMIN D 2000 for an unknown indication.   On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Feb-2021, the patient experienced DECREASED APPETITE, ASTHENIA (weakness), NAUSEA, HEADACHE (Intense headache varying in intensity), and CHILLS. On an unknown date, the patient experienced PYREXIA (Low Grade Fever/ 100F and lower). At the time of the report, DECREASED APPETITE, ASTHENIA (weakness), NAUSEA, PYREXIA (Low Grade Fever/ 100F and lower), HEADACHE (Intense headache varying in intensity), and CHILLS outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2021, Body temperature: 100f (normal) 100F.         The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was considered to be not applicable.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Patient demographics, lab data, and concomitant medications were updated. Two events were added (chills and loss of appetite). On 19-Apr-2021: additional information received on 19-APR-2021 and does not contain any new information
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 22-May-2021. On 22-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported. Patient was 25 weeks pregnant at the time of vaccination.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: Maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination.     No medical history information reported.  Concomitant products included PRENATAL VITAMIN for an unknown indication.   On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 08-Oct-2021. On 30-Dec-2020, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY had not resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Treatment information was not provided.