chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever; A spontaneous report was received from a consumer, concerning a female patient who was administered Moderna's COVID-19 vaccine (mRNA-1273) and experienced fever.   The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 30-DEC-2020, the patient received their first of two planned doses of mRNA-1273 (batch unknown) intramuscularly for prophylaxis of COVID-19 infection.   On an unspecified date, after vaccination the patient had experienced fever. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.   Outcome of the event fever was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk
Clinical narrative: Breast feeding 6 months old son; breast feeding 3-month-old son; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 31-Dec-2020 and was forwarded to Moderna on 04-Jan-2021.    This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of EXPOSURE VIA BREAST MILK (breast feeding 3-month-old son) and EXPOSURE VIA BREAST MILK (Breast feeding 6 months old son) in a 3-month-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    MEDICAL HISTORY (Parent): The mother's past medical history included Gestational hypertension. Concurrent medical conditions included Alcohol use (occasional glass of wine) and Maternal exposure during breast feeding.    MEDICAL HISTORY (Patient): The patient's past medical history included Fetal growth restriction (IUGR). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and FISH OIL (OMEGA 3 FISH OILS) for an unknown indication.    On 24-Dec-2020 at 7:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary) 1 dosage form. On 24-Dec-2020, the patient experienced EXPOSURE VIA BREAST MILK (breast feeding 3-month-old son). On 25-Mar-2021, the patient experienced EXPOSURE VIA BREAST MILK (Breast feeding 6 months old son). On 24-Dec-2020, EXPOSURE VIA BREAST MILK (breast feeding 3-month-old son) had resolved. On 25-Mar-2021, EXPOSURE VIA BREAST MILK (Breast feeding 6 months old son) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Transmammary), the reporter did not provide any causality assessments.   Concomitant medications were not reported  This is a case of product exposure during breastfeeding with no associated AEs. The mother of the child will continue to be contacted for further monitoring of AEs in the child.    This case was linked to MOD-2020-041455, MOD-2020-041455, MOD-2020-001985 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Mar-2021: No specific follow-up information recorded. On 25-Mar-2021: No specific follow-up information recorded. On 25-Mar-2021: No specific follow-up information recorded.; Sender's Comments: This is a case of product exposure during breastfeeding with no associated AEs. The mother of the child will continue to be contacted for further monitoring of AEs in the child.
Age: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Body temperature, Chills, Diarrhoea
Clinical narrative: Diarrhea; Fever of 101 F; Lightheadedness; Migraine; Back Pain; Arm Pain; Chills; Whole body weakness; Legs are weak cannot stand up; A spontaneous report was received from a consumer concerning a 34 year old male patient,  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of arm pain, migraine, diarrhea, fever of 101F, chills, back pain, whole body weakness, lightheadedness and leg weakness that he feels he cannot stand up.  The patient's medical history was not provided. No concomitant medications were reported.  On 30 Dec 2020, the patient received his first of two planned doses of mRNA-1273 (Lot number unknown).   On 31 Dec 2020, the patient experienced arm pain, migraine, diarrhea, fever of 101F, chills, back pain, whole body weakness, lightheadedness and leg weakness that he  feels he cannot stand up. The treatment information included paracetamol and excedrin.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, arm pain, migraine, diarrhea, fever of 101F, chills, back pain, whole body weakness, lightheadedness and legs are weak he feels he cannot stand up was considered as not resolved.; 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: 34.0
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Migraine, Muscular weakness, Pyrexia, Vaccination site pain
Clinical narrative: Diarrhea; Fever of 101 F; Lightheadedness; Migraine; Back Pain; Arm Pain; Chills; Whole body weakness; Legs are weak cannot stand up; A spontaneous report was received from a consumer concerning a 34 year old male patient,  who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced multiple events of arm pain, migraine, diarrhea, fever of 101F, chills, back pain, whole body weakness, lightheadedness and leg weakness that he feels he cannot stand up.  The patient's medical history was not provided. No concomitant medications were reported.  On 30 Dec 2020, the patient received his first of two planned doses of mRNA-1273 (Lot number unknown).   On 31 Dec 2020, the patient experienced arm pain, migraine, diarrhea, fever of 101F, chills, back pain, whole body weakness, lightheadedness and leg weakness that he  feels he cannot stand up. The treatment information included paracetamol and excedrin.  The Action taken with mRNA-1273 in response to the events was unknown.  The outcome for the events, arm pain, migraine, diarrhea, fever of 101F, chills, back pain, whole body weakness, lightheadedness and legs are weak he feels he cannot stand up was considered as not resolved.; 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: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Insomnia, Nasopharyngitis, Pain in extremity, SARS-CoV-2 test
Clinical narrative: Not feeling okay; Feel like I have a cold; Arm extremely sore; Received vaccine while actively infected with COVID-19; Problems sleeping; A spontaneous report was received from a 75 year old, female, consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and received the vaccine while actively infected with COVID-19, and experienced arm extremely sore, problems sleeping, not feeling okay, and feel like I have a cold.   The patient's medical history included a COVID-19 test taken on 21 Dec 2020 with a positive result on 30 Dec 2020 at 20:00. Concomitant medications reported included levothyroxine sodium, vitamins, allergy medication (not specified), omega-3 fatty acids and calcium.   On 30 Dec 2020, several hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient reported that on 21 Dec 2020, she underwent COVID-19 testing and received positive test results, several hours after receiving the Moderna COVID vaccine on 30 Dec 2020. She also reported that her arm was extremely sore, problems sleeping, not feeling okay, and feeling like she had a cold. Treatment reported included oxymetazoline hydrochloride, pyrilamine / mepyramine / chlophedianol, and sulfamethoxazole / trimethoprim.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, received vaccine while actively infected with COVID-19, arm extremely sore, problems sleeping, not feeling okay, and feel like I have a cold, were not reported.; Reporter's Comments: This case concerns a 75-year-old female who experienced NS events of unexpected SARS-CoV-2 test positive, feeling abnormal, nasopharyngitis, insomnia, and pain in extremity.  Event onset occurred the same day as the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event of extremely sore arm, insomnia and feeling unwell,  like having a cold, a causal relationship cannot be excluded.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Not feeling okay; Feel like I have a cold; Arm extremely sore; Received vaccine while actively infected with COVID-19; Problems sleeping; A spontaneous report was received from a 75 year old, female, consumer who received Moderna's COVID-19 vaccine (mRNA-1273) and received the vaccine while actively infected with COVID-19, and experienced arm extremely sore, problems sleeping, not feeling okay, and feel like I have a cold.   The patient's medical history included a COVID-19 test taken on 21 Dec 2020 with a positive result on 30 Dec 2020 at 20:00. Concomitant medications reported included levothyroxine sodium, vitamins, allergy medication (not specified), omega-3 fatty acids and calcium.   On 30 Dec 2020, several hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 011L20A) intramuscularly for prophylaxis of COVID-19 infection.   On 31 Dec 2020, the patient reported that on 21 Dec 2020, she underwent COVID-19 testing and received positive test results, several hours after receiving the Moderna COVID vaccine on 30 Dec 2020. She also reported that her arm was extremely sore, problems sleeping, not feeling okay, and feeling like she had a cold. Treatment reported included oxymetazoline hydrochloride, pyrilamine / mepyramine / chlophedianol, and sulfamethoxazole / trimethoprim.   Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events, received vaccine while actively infected with COVID-19, arm extremely sore, problems sleeping, not feeling okay, and feel like I have a cold, were not reported.; Reporter's Comments: This case concerns a 75-year-old female who experienced NS events of unexpected SARS-CoV-2 test positive, feeling abnormal, nasopharyngitis, insomnia, and pain in extremity.  Event onset occurred the same day as the first dose of mRNA-1273. Based on the current available information and temporal association between the use of the product and the start date of the event of extremely sore arm, insomnia and feeling unwell,  like having a cold, a causal relationship cannot be excluded.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, No adverse event, Product administered to patient of inappropriate age, Product preparation issue, Wrong product administered
Clinical narrative: On 09AUG 2021 a vial of Janssen was mistake to be Pfizer. Janssen vial was given 1.8ml of Pfizer diluent and then 0.3ml of diluted Janssen was given to 16 year old female (instead of scheduled second Pfizer dose).  Family notified immediately and reported no symptoms.  Family offered evaluation in hospital's which they declined. Per CDC Administration Error guideline, no further doses should be given.  will discuss with state covid team to see if diluted Janssen should be then followed by Pfizer vaccination.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Ultrasound scan
Clinical narrative: Neck Lymph nodes inflammation. Being tested for a posible lymphoma
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Retinal detachment
Clinical narrative: I experienced a retina detachment six months after my second shot of the Moderna vaccine. I am reporting this as a possible side effect because several others in my area have experienced the same condition after receiving the Moderna vaccine.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Dry mouth
Clinical narrative: Dry mouth
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Hypotension, Nausea, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium, Systemic: Hypotension-Medium, Systemic: Nausea-Medium
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Paraesthesia, Pruritus, Pyrexia
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Fever-Mild, Systemic: Flushed / Sweating-Severe, Additional Details: Patient experienced tingling in left arm and subsequent itching. She then became flushed and sweating. Emergency services were called and she was brought to hospital for further evaluation
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Medium
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: Sore arm for 3 days. On the 4th day, I experienced numbness in hands and feet. Bottoms of feet were burning. Numbness went into my thighs. Dizziness and faintness. Lasted all day and numbness in hands stayed until the following day which accompanied a headache that lasted all that next day.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope
Clinical narrative: Sore arm for 3 days. On the 4th day, I experienced numbness in hands and feet. Bottoms of feet were burning. Numbness went into my thighs. Dizziness and faintness. Lasted all day and numbness in hands stayed until the following day which accompanied a headache that lasted all that next day.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Medium, Systemic: Allergic: Rash Generalized-Medium, Systemic: Numbness (specify: facial area, extremities)-Medium
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Malaise, Peripheral swelling
Clinical narrative: My upper left arm is waa swollen and felt like it's on fire. It's still swollen but not burning anymore. Can't keep anything down, Everytime I eat I get sick.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Fatigue, Flushing
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Lethargy, Pain, Pyrexia
Clinical narrative: Systemic: Body Aches Generalized-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fever-Medium, Systemic: Flushed / Sweating-Medium
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Extra dose administered, Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Throat tightness, Tremor
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Shakiness-Mild, Additional Details: EMS was called, pt said she was feeling fine and didn't want to go with EMS.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chest pain, Dysphagia, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Shakiness-Mild, Additional Details: EMS was called, pt said she was feeling fine and didn't want to go with EMS.
Age: 50.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Throat tightness
Clinical narrative: Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Shakiness-Mild, Additional Details: EMS was called, pt said she was feeling fine and didn't want to go with EMS.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 64.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Chest pain, Tinnitus
Clinical narrative: Ringing in my ears which has not gotten better, I also have experienced some minor chest pains, and I have experienced joint pains.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Head injury, Hyperhidrosis, Nausea
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Patient fainted briefly after getting Pfizer vaccine.  She bumped her head on the wall when she passed out.  She was alert and awake by the time I came out of the pharmacy.  Mom was there to make sure she did not fall on the ground and also mentioned she has anxiety with vaccinations.  I monitored her for 30 minutes after the incident.  I gave her water, a granola bar, and an ice pack to help with sysmptoms.  She was alert and okay when the family left the pharmacy.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Nausea-Mild, Additional Details: Patient fainted briefly after getting Pfizer vaccine.  She bumped her head on the wall when she passed out.  She was alert and awake by the time I came out of the pharmacy.  Mom was there to make sure she did not fall on the ground and also mentioned she has anxiety with vaccinations.  I monitored her for 30 minutes after the incident.  I gave her water, a granola bar, and an ice pack to help with sysmptoms.  She was alert and okay when the family left the pharmacy.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Exposure during pregnancy, Palpitations, Vertigo
Clinical narrative: I was 37 weeks at the time of my moderna vaccine with an estimated due date of 8/26/21. I was talking to the pharmacist and the room spinned around for a few seconds when I looked  straight. I was felt dizzy for a few seconds. Within 30 minutes and on and off throughout the first day I had heart palpitations. I rested when I got home which felt better for me. But after waking up the heart palpitations returned on and off. I'm on day 3 post vaccine and from day 2 until now I feel better. I just wanted to share my experience as a pregnant mom if it helps.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site bruising, Injection site erythema, Injection site indentation, Injection site pain
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Customer states immunizer injected at angle, once injected, syringe was straigtened at 90 degrees, felt pain and muscle ache.  Husband and Mom witnessed and questioned immunizer if thats normal he said "no" according to customer.  Customer has tried numerous home remedies including tylenol and ibuprofen no relief.  Stated site is hard and painful like "muscle torn"
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Limb injury, Paraesthesia
Clinical narrative: Site: Bruising at Injection Site-Mild, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Joint Pain-Medium, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-, Additional Details: Customer states immunizer injected at angle, once injected, syringe was straigtened at 90 degrees, felt pain and muscle ache.  Husband and Mom witnessed and questioned immunizer if thats normal he said "no" according to customer.  Customer has tried numerous home remedies including tylenol and ibuprofen no relief.  Stated site is hard and painful like "muscle torn"
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia
Clinical narrative: Headache, Fever, sore arm, tiredness.  Fever only breaking ~3:30 AM Monday Morning (8/9/2021).
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Face injury, Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted after receipt of vaccine and hit his face on the ground resulting into bruising. He immediate regained consciousness. EMS was called and pt taken to ER for monitoring.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: 6 syringes were drawn up @ 9:07 AM on 8/3/21 and marked with an expiration sticker with the time of 3:07pm.  Vaccine was inadvertently given @ 4:12 pm.   Patient was contacted and informed and reports no side effects.  Advised that we would contact Pfizer to find out the next steps and to see if he will need to start the series over again..  Will  contact patient once we hear back from Pfizer about validity of vaccine.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Systemic: postive for COVID-Mild, Additional Details: pt tested positive for covid.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Nasal congestion, Rhinorrhoea, Sneezing, Throat tightness
Clinical narrative: Runny/stuffy nose, constant sneezing, cough, tightness in throat since April.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle twitching, Syncope, Tremor, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Shakiness-Mild, Additional Details: Patient fainted twice while at the pharmacy vaccine waiting area. Her mother held her while she was fainting. She experienced twitching/shakiness during the times of fainting. Gave her juice, water, and cookies. She laid down for about 20 mins. Overall time of watching patient was 1 hr. Her mom refused epipen and 911. Left feeling better. Patient does have hx of fainting from vaccines and was disclosed at time of vaccination.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Enlarged and painful axillary lymph nodes
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Hypoaesthesia, Injection site pain, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Diarrhea-Mild, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypertension, Tachycardia
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Headache-Medium, Systemic: Hypertension-Medium, Systemic: Tachycardia-Medium, Additional Details: Patients original BP was 146/97 and HR 102. Second reading 5 minutes later was 142/93 and HR 98. Patient wanted to go home and rest. She had a pretty bad headache after the 2nd injection. She was advised to take tylenol.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Flushing, Hyperhidrosis, Injection site erythema, Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Diarrhea-Medium, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy, Nausea, Pain, Pyrexia
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Diarrhea-Medium, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash Generalized-Medium, Systemic: Body Aches Generalized-Medium, Systemic: Diarrhea-Medium, Systemic: Fever-Severe, Systemic: Flushed / Sweating-Medium, Systemic: Lymph Node Swelling-Medium, Systemic: Nausea-Medium
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Abdominal distension, Back pain, Diarrhoea, Dysmenorrhoea, Intermenstrual bleeding
Clinical narrative: My first periods after both vaccine shots came a week earlier than usual (unusual for me), had odd spotting/bleeding/cramping (compared to normal), and accompanied by lower back pain (sometimes too stiff to stand straight), bloating that doesn?t go away, and my first period without the shot came two weeks late, was shorter than usual, and accompanied by the same unusual symptoms as the periods after the shots (odd spotting, bleeding, and cramping). The back pain is not as bad after some time, but it comes and goes, and some days I still cannot stand straight without pain. The bloating has also been consistent since vaccination; it doesn?t go away (where before vaccination I only bloated during my period).
Age: 22.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Menstrual disorder, Musculoskeletal stiffness, Nausea
Clinical narrative: My first periods after both vaccine shots came a week earlier than usual (unusual for me), had odd spotting/bleeding/cramping (compared to normal), and accompanied by lower back pain (sometimes too stiff to stand straight), bloating that doesn?t go away, and my first period without the shot came two weeks late, was shorter than usual, and accompanied by the same unusual symptoms as the periods after the shots (odd spotting, bleeding, and cramping). The back pain is not as bad after some time, but it comes and goes, and some days I still cannot stand straight without pain. The bloating has also been consistent since vaccination; it doesn?t go away (where before vaccination I only bloated during my period).
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus "hissing" in both ears.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dizziness, Dyspnoea, Hypoacusis
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient was nervous upon arrival.  Stated did not eat breakfast or any foods.  After administration, waited, then walked around to get Tylenol.  Felt dizzy, "distant muffle" hearing, shortness of breath, chest tightness.  911 was called.  Emergency service responded.  Patient felt better and left store when Emergency service responders left the store.  Pharmacist called to follow up.  Patient reported feeling fine.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Hypoaesthesia, Limb discomfort
Clinical narrative: Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Weakness-Medium, Additional Details: He stated that his left arm went numb (the arm that he received the injection in) and that it then felt heavy. He told me this 15 minutes after he had received the vaccination. I did give him the pharmacy phone number if he had any further issues, he did not call the next day.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Injection site erythema, Injection site pruritus
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: PATIENT RECEIVED HER FIRST DOSE OF MODERNA TODAY ON 8/8/2021 AND AFTER 5 MINUTES HAD A RASH/ITCHING SO PHARMACIST TOLD HER TO WAIT FOR 30 MINUTES AND GAVE HER BENADRYL. PATIENT FELT BETTER AND DECIDED TO LEAVE. PATIENT CALLED PHARMACY BACK AND STATED AFTER 90 MINUTES LEAVING THE PHARMACY THAT SHE FELT A TIGHTNESS IN HER CHEST AND DIFFICULTY BREATHING. SHE WENT TO URGENT CARE LIKE THE PHARMACIST TOLD HER TO IF NEEDED. THE URGENT CARE GAVE HER A DOSE OF EPIPEN AND SHORTLY AFTER SHE LEFT.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Difficulty Breathing-Medium, Systemic: Chest Tightness / Heaviness / Pain-Medium, Additional Details: PATIENT RECEIVED HER FIRST DOSE OF MODERNA TODAY ON 8/8/2021 AND AFTER 5 MINUTES HAD A RASH/ITCHING SO PHARMACIST TOLD HER TO WAIT FOR 30 MINUTES AND GAVE HER BENADRYL. PATIENT FELT BETTER AND DECIDED TO LEAVE. PATIENT CALLED PHARMACY BACK AND STATED AFTER 90 MINUTES LEAVING THE PHARMACY THAT SHE FELT A TIGHTNESS IN HER CHEST AND DIFFICULTY BREATHING. SHE WENT TO URGENT CARE LIKE THE PHARMACIST TOLD HER TO IF NEEDED. THE URGENT CARE GAVE HER A DOSE OF EPIPEN AND SHORTLY AFTER SHE LEFT.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Flushing, Myalgia, Paraesthesia, Pruritus
Clinical narrative: Tingling in Extremities; Flushing; Desperate Itch All Over Body/developed itching; Muscle Aching After Rest; Temperature of 100 degrees F; This spontaneous case was reported by a nurse and describes the occurrence of PARAESTHESIA, FLUSHING, PRURITUS, MYALGIA, and PYREXIA in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Itching all over.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced PARAESTHESIA, FLUSHING, PRURITUS, MYALGIA, and PYREXIA. At the time of the report, PARAESTHESIA, FLUSHING, PRURITUS, MYALGIA, and PYREXIA outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 100 °F (Borderline).     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.   Treatment for the event included periactin three times per day.  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. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Tingling in Extremities; Flushing; Desperate Itch All Over Body/developed itching; Muscle Aching After Rest; Temperature of 100 degrees F; This spontaneous case was reported by a nurse and describes the occurrence of PARAESTHESIA, FLUSHING, PRURITUS, MYALGIA, and PYREXIA in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Itching all over.    On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced PARAESTHESIA, FLUSHING, PRURITUS, MYALGIA, and PYREXIA. At the time of the report, PARAESTHESIA, FLUSHING, PRURITUS, MYALGIA, and PYREXIA outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 100 °F (Borderline).     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.   Treatment for the event included periactin three times per day.  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. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Inflammation, Lymphadenopathy, Pain in extremity
Clinical narrative: Inflamation on the left side of the neck; Pain at the injection site; Swelling; Pain in the axillary; Swelling in the axillary nodes; Chills; Pain in the arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY, INFLAMMATION, VACCINATION SITE PAIN, VACCINATION SITE SWELLING, and AXILLARY PAIN in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. OJ20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CALCIUM for Prophylaxis.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Dec-2020, the patient experienced PAIN IN EXTREMITY, VACCINATION SITE PAIN, VACCINATION SITE SWELLING, AXILLARY PAIN, LYMPHADENOPATHY, and CHILLS. On 28-Dec-2020, the patient experienced INFLAMMATION. At the time of the report, PAIN IN EXTREMITY, INFLAMMATION, VACCINATION SITE PAIN, VACCINATION SITE SWELLING, AXILLARY PAIN, LYMPHADENOPATHY, and CHILLS 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.   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. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Inflamation on the left side of the neck; Pain at the injection site; Swelling; Pain in the axillary; Swelling in the axillary nodes; Chills; Pain in the arm; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY, INFLAMMATION, VACCINATION SITE PAIN, VACCINATION SITE SWELLING, and AXILLARY PAIN in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. OJ20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event (No reported medical history). Concomitant products included CALCIUM for Prophylaxis.    On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Dec-2020, the patient experienced PAIN IN EXTREMITY, VACCINATION SITE PAIN, VACCINATION SITE SWELLING, AXILLARY PAIN, LYMPHADENOPATHY, and CHILLS. On 28-Dec-2020, the patient experienced INFLAMMATION. At the time of the report, PAIN IN EXTREMITY, INFLAMMATION, VACCINATION SITE PAIN, VACCINATION SITE SWELLING, AXILLARY PAIN, LYMPHADENOPATHY, and CHILLS 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.   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. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: Gout Breakout; This spontaneous report was received from a consumer on 04JAN2021 refers to a female patient who received the Moderna COVID-19 vaccine and experienced a "gout breakout".  The patient's medical history was not provided. Concomitant medications were not reported.   On 02JAN2021, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 intramuscularly (Lot number: not provided). Two days later on 04JAN2021, the patient developed a gout flare, reporting, gout breakout.  The patient agreed to safety follow-up as she stated that she has not taken the medicine for the gout, fearing a potential drug interaction.  The action taken for Moderna COVID-19 Vaccine was not reported. The outcome of the event, gout breakout, was not reported. Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded. However, interruption of medicine for the gout is considered a confounder.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Injection site pain, Injection site swelling, Nightmare, Panic attack
Clinical narrative: Nightmare; Panic attack; Anxiety; pain at the injection site; swollen arm; This spontaneous report was received from a consumer which refers to a 68-year-old female Nurse patient who received the Moderna COVID-19 vaccine and experienced arm swelling and pain at the injection site, a nightmare, panic attack and anxiety.  The patient's medical history was not provided. Concomitant medications were not reported.   On 03 JAN 2021, prior to the onset of the symptoms, the patient received her first of two planned doses of mRNA-1273 intramuscularly (Lot number: not provided).   The patient had the first Moderna COVID-19 Vaccine on 03 JAN 2021 and reported, experienced swollen arm and pain at the injection site. On 04 JAN 2021 she experienced a nightmare, panic attack and anxiety. All symptoms are ongoing. The patient was advised to follow-up with her healthcare provider for decisions on symptoms management.  The action taken for Moderna COVID-19 Vaccine was not reported.   The outcome of the events, swollen arm and pain at the injection site, nightmare, panic attack and anxiety was not reported.; Reporter's Comments: This case concerns a 68-year-old female who experienced NS events of unexpected nightmare, panic attack, anxiety and expected injection site pain, injection site swelling.  Event onset occurred the same day as the first dose of mRNA-1273. Treatment not reported. Events ongoing. 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: Feeling exhausted; Still did not feel good; Lost range of motion in right arm; Shaking; Restless; Could not stop chilling; Achy all over; Fever; Injection hurt more than any other IM injection including but not limited to the influenza vaccine; had a terrible headache following vaccination; This spontaneous report was received from a nurse concerning a 61 year old female patient who experienced achy all over (pain),  lost range of motion in right arm (joint range of motion decreased),  shaking (tremor), still did not feel good (malaise),  had a terrible headache following vaccination (headache), could not stop chilling (chills), fever (pyrexia), injection hurt more than any other IM injection including but not limited to the influenza vaccine (injection site pain), restless (restlessness) and feeling exhausted (fatigue).  The patient's medical history included COVID 19. Concomitant medications were not reported.   On 03 JAN 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot 039K20-2A) intramuscularly in the right deltoid.  On 03 Jan 2021, the patient experienced injection hurt more than any other IM injection including but not limited to the influenza vaccine, a diminished range of motion in her right arm, which got worse through the night. Within two hours, after vaccination, she began to feel achy all over. She was chilling and shaking and stated that her pain level increased from one to seven and she was restless with the pain overnight. Her temperature went up to 102 degrees F, and day after receiving vaccine she used Tylenol which brought it down to 100, but she still did not feel good. All symptoms that she attributes to the vaccine started fast and she felt like she actually had COVID 19. She had terrible headache, following vaccination, and chills. When she was diagnosed with  COVID, could not taste or smell, and her sense of smell and taste is still touch and go, but she does not believe it was related to the vaccine. Symptoms are no longer ongoing.  Treatment for the events included Tylenol.   Action taken with  mRNA-1273 in response to the events was not applicable. Second dose was scheduled for 29 JAN 2021.   The events of achy all over (pain),  lost range of motion in right arm (joint range of motion decreased),  shaking (tremor), still did not feel good (malaise), had a terrible headache following vaccination (headache), could not stop chilling (chills), fever (pyrexia), injection hurt more than any other IM injection including but not limited to the influenza vaccine (injection site pain), restless (restlessness) and feeling exhausted (fatigue) were considered recovered.; 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: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Malaise, Pain, Pyrexia, Restlessness
Clinical narrative: Feeling exhausted; Still did not feel good; Lost range of motion in right arm; Shaking; Restless; Could not stop chilling; Achy all over; Fever; Injection hurt more than any other IM injection including but not limited to the influenza vaccine; had a terrible headache following vaccination; This spontaneous report was received from a nurse concerning a 61 year old female patient who experienced achy all over (pain),  lost range of motion in right arm (joint range of motion decreased),  shaking (tremor), still did not feel good (malaise),  had a terrible headache following vaccination (headache), could not stop chilling (chills), fever (pyrexia), injection hurt more than any other IM injection including but not limited to the influenza vaccine (injection site pain), restless (restlessness) and feeling exhausted (fatigue).  The patient's medical history included COVID 19. Concomitant medications were not reported.   On 03 JAN 2021, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Lot 039K20-2A) intramuscularly in the right deltoid.  On 03 Jan 2021, the patient experienced injection hurt more than any other IM injection including but not limited to the influenza vaccine, a diminished range of motion in her right arm, which got worse through the night. Within two hours, after vaccination, she began to feel achy all over. She was chilling and shaking and stated that her pain level increased from one to seven and she was restless with the pain overnight. Her temperature went up to 102 degrees F, and day after receiving vaccine she used Tylenol which brought it down to 100, but she still did not feel good. All symptoms that she attributes to the vaccine started fast and she felt like she actually had COVID 19. She had terrible headache, following vaccination, and chills. When she was diagnosed with  COVID, could not taste or smell, and her sense of smell and taste is still touch and go, but she does not believe it was related to the vaccine. Symptoms are no longer ongoing.  Treatment for the events included Tylenol.   Action taken with  mRNA-1273 in response to the events was not applicable. Second dose was scheduled for 29 JAN 2021.   The events of achy all over (pain),  lost range of motion in right arm (joint range of motion decreased),  shaking (tremor), still did not feel good (malaise), had a terrible headache following vaccination (headache), could not stop chilling (chills), fever (pyrexia), injection hurt more than any other IM injection including but not limited to the influenza vaccine (injection site pain), restless (restlessness) and feeling exhausted (fatigue) were considered recovered.; 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.