chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Lymph Node Swelling-Mild, Additional Details: Patient had bruising on arm with blisters that were leaking fluid. Blister was worse on the day she received the vaccine and has healed slightly. Blister continuously leaks fluid.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blister
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Lymph Node Swelling-Mild, Additional Details: Patient had bruising on arm with blisters that were leaking fluid. Blister was worse on the day she received the vaccine and has healed slightly. Blister continuously leaks fluid.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blister, Burning sensation, Burns second degree, Pain, Scar
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Lymph Node Swelling-Mild, Additional Details: Patient had bruising on arm with blisters that were leaking fluid. Blister was worse on the day she received the vaccine and has healed slightly. Blister continuously leaks fluid.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Wound
Clinical narrative: Site: Bruising at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Lymph Node Swelling-Mild, Additional Details: Patient had bruising on arm with blisters that were leaking fluid. Blister was worse on the day she received the vaccine and has healed slightly. Blister continuously leaks fluid.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Pain
Clinical narrative: Systemic: Body Aches Generalized-Mild, Systemic: Chest Tightness/Heaviness/Pain-Medium, Additional Details: Patient reported chest tightness and generalized body aches beginning 2 days after receiving booster dose of Pfizer/BioNTech vaccine. Patient stated chest tightness made it difficult to take a deep breath or even yawn. She described the tightness as "crushing," but said it resolved quickly. She has continued to improve back to baseline. All adverse effects reported resolved at the time of patient report.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Flushing, Hyperhidrosis, Hyperventilation
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Systemic: Tinnitus-Medium, Systemic: Weakness-Medium, Additional Details: Patient fainted but remained responsive. Before fainting, patient complained of ringing in ears and problems with breathing (hard to breathe). Patient felt better after about 20 minutes. She didn't want to call another family member or ambulance.  She left by herself and was doing fine.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Syncope, Tinnitus, Tremor, Unresponsive to stimuli
Clinical narrative: Site: Pain at Injection Site-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hyperventilation-Medium, Systemic: Shakiness-Medium, Systemic: Tinnitus-Medium, Systemic: Weakness-Medium, Additional Details: Patient fainted but remained responsive. Before fainting, patient complained of ringing in ears and problems with breathing (hard to breathe). Patient felt better after about 20 minutes. She didn't want to call another family member or ambulance.  She left by herself and was doing fine.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Headache-Severe, Systemic: Nausea-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Limb injury, Nausea, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Headache-Severe, Systemic: Nausea-Severe, Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Altered state of consciousness, Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Severe, Additional Details: ~2 mins post shot pt became unresponsive/fainted, after ~2 mins regained consciousness, ~20 mins later was back to full awareness
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low-
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness/Lightheadedness-Severe, Additional Details: We called 911. Patient explained to my technician that all she felt was dizziness.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster given too early.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Dyspnoea
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Medium.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, 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-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Reaction started day after injection and was more severe initially.  Saw provider  Dr due to scheduled appointment who characterized the red swolled arm as an adverse reaction. No treatment given at this time.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Mild, Site: Swelling at Injection Site-Mild, Additional Details: Reaction started day after injection and was more severe initially.  Saw provider  Dr due to scheduled appointment who characterized the red swolled arm as an adverse reaction. No treatment given at this time.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong dose of vaccine - too low.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy
Clinical narrative: Site: Swelling at Injection Site-Severe, Systemic: Lymph Node Swelling-Severe
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy
Clinical narrative: Site: Swelling at Injection Site-Severe, Systemic: Lymph Node Swelling-Medium
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Pt received Moderna COVID-19 Booster dose & Fluzone Quad 2021-2022 shots in the same arm. Administered Moderna COVID-19 booster first, & then flushot 1 inch apart. After administering flushot & as I was applying the bandaid, pt fainted a little by leaning forward. I caught pt & loudly called their name, & pt came too right away. Event only lasted a few seconds. Pt then admitted to fear of needles & 2nd shot (flu shot) scared them & they fainted. Had pt sit for 30 mins & pt had no other reactions
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong dose of vaccine - too high.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Headache, Nausea, Somnolence
Clinical narrative: 7 hours after the booster dose of Moderna patient reports headache on top of head and between the eyes, nausea. Headache lasted 2 weeks, stopped for a week, then comes back. Nausea has been continuous. Fatigue and short of breath has been continuous. Sleeps for 10 hours a day.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Confusional state, Dizziness, Dysstasia
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient came in with mother. Received her vaccine first, got up and allowed mother to sit and receive her vaccine. Sooner after mother received vaccine pt (standing upright) began to fall over and lose contiousness. Mother and I were able to lower her to the ground where she regained contiousness a few seconds later. She appear very dazed and confused and could not stand up. We called 911 and the fire departmentand they arrived within minutes to check her. She was transported to ER.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Fatigue, Feeling abnormal, Lethargy, Loss of consciousness
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient came in with mother. Received her vaccine first, got up and allowed mother to sit and receive her vaccine. Sooner after mother received vaccine pt (standing upright) began to fall over and lose contiousness. Mother and I were able to lower her to the ground where she regained contiousness a few seconds later. She appear very dazed and confused and could not stand up. We called 911 and the fire departmentand they arrived within minutes to check her. She was transported to ER.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Chest Tightness / Heaviness / Pain-Medium, Systemic: Confusion-Medium, Systemic: Dizziness / Lightheadness-Medium, Systemic: Exhaustion / Lethargy-Medium, Systemic: Fainting / Unresponsive-Severe, Additional Details: Patient came in with mother. Received her vaccine first, got up and allowed mother to sit and receive her vaccine. Sooner after mother received vaccine pt (standing upright) began to fall over and lose contiousness. Mother and I were able to lower her to the ground where she regained contiousness a few seconds later. She appear very dazed and confused and could not stand up. We called 911 and the fire departmentand they arrived within minutes to check her. She was transported to ER.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Limb injury, Paraesthesia
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Abdominal pain upper, Angina pectoris, Back pain, Blood thyroid stimulating hormone
Clinical narrative: SYMPTOMS: - COUGH STARTING THE  DAY AFTER THE INJECTION FOR ABOUT 2 WEEKS - PARESTHESIS IN LEFT ARM FOR ABOUT 3 WEEKS (PARESTHESIS IS NOT PRESENT ANYMORE) - INTTERUPTION OF MENSTRUAL CYCLE THE DAY AFTER THE SHOT (3RD DAY OF CYCLE) - MENSTRUAL CYCLE IS FORTNIGHTLY SINCE (IS STILL A  PROBLEM) - PAIN LOCALISED IN LEFT SHOULDER AND BACK (AREA: T2 - T4, LEFT RHOMBOID, LEFT SUPRASPINATUS, LEFT INFRASPIANTUS) (STARTING THE DAY AFTER THE INJECTION AND IS STILL PRESENT) - CHEST PAIN LEFT SIDE (HEART) - SEVERE ABDOMINAL PAIN IN EPIGASTRIC  & LEFT HYPOCHONDRIAL AREA (PAIN IS UNDER CONTROL WITH PENTASA TREATMENT) -  DIARRHEA (TREATED WITH ENTEROL & PENTASA)
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: C-reactive protein normal, Cough, Culture stool, Diarrhoea, Faecal calprotectin
Clinical narrative: SYMPTOMS: - COUGH STARTING THE  DAY AFTER THE INJECTION FOR ABOUT 2 WEEKS - PARESTHESIS IN LEFT ARM FOR ABOUT 3 WEEKS (PARESTHESIS IS NOT PRESENT ANYMORE) - INTTERUPTION OF MENSTRUAL CYCLE THE DAY AFTER THE SHOT (3RD DAY OF CYCLE) - MENSTRUAL CYCLE IS FORTNIGHTLY SINCE (IS STILL A  PROBLEM) - PAIN LOCALISED IN LEFT SHOULDER AND BACK (AREA: T2 - T4, LEFT RHOMBOID, LEFT SUPRASPINATUS, LEFT INFRASPIANTUS) (STARTING THE DAY AFTER THE INJECTION AND IS STILL PRESENT) - CHEST PAIN LEFT SIDE (HEART) - SEVERE ABDOMINAL PAIN IN EPIGASTRIC  & LEFT HYPOCHONDRIAL AREA (PAIN IS UNDER CONTROL WITH PENTASA TREATMENT) -  DIARRHEA (TREATED WITH ENTEROL & PENTASA)
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Menstrual disorder, Monocyte count increased, Paraesthesia, White blood cell count
Clinical narrative: SYMPTOMS: - COUGH STARTING THE  DAY AFTER THE INJECTION FOR ABOUT 2 WEEKS - PARESTHESIS IN LEFT ARM FOR ABOUT 3 WEEKS (PARESTHESIS IS NOT PRESENT ANYMORE) - INTTERUPTION OF MENSTRUAL CYCLE THE DAY AFTER THE SHOT (3RD DAY OF CYCLE) - MENSTRUAL CYCLE IS FORTNIGHTLY SINCE (IS STILL A  PROBLEM) - PAIN LOCALISED IN LEFT SHOULDER AND BACK (AREA: T2 - T4, LEFT RHOMBOID, LEFT SUPRASPINATUS, LEFT INFRASPIANTUS) (STARTING THE DAY AFTER THE INJECTION AND IS STILL PRESENT) - CHEST PAIN LEFT SIDE (HEART) - SEVERE ABDOMINAL PAIN IN EPIGASTRIC  & LEFT HYPOCHONDRIAL AREA (PAIN IS UNDER CONTROL WITH PENTASA TREATMENT) -  DIARRHEA (TREATED WITH ENTEROL & PENTASA)
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site pain, Pain in extremity
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: arm pain-Severe, Systemic: Joint Pain-Severe, Additional Details: Pt called stating she thinks the vaccine was given too high, cause her immense pain and she had to visit the urgent care. Arm is now in a sling and patient is taking tylenol #3 for the pain.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Headache, Hyperhidrosis, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Systemic: Headache-Mild
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error, Product preparation issue
Clinical narrative: Error: Incorrect Reconstitution-
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Condition aggravated, Headache, Injection site rash, Pain
Clinical narrative: tremors increased, Raynauds symptoms were triggered, pain in left foot and massive headache all happened within minutes.  Went home after 45 mins.  Temperature dropped to 95 degrees and it took 3 hrs & many layers of clothes to warm up.  Arm became very painful within a couple hours.  Hurt to move or use for 2 days.  2nd day the headache continued, as did the increased tremors.  Ran a 99.9 fever for a few hours, then temp dropped to 95 degrees in evening.  This has continued every evening since.  On the 3rd day a rash developed on the injection shoulder.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Raynaud's phenomenon, Tremor
Clinical narrative: tremors increased, Raynauds symptoms were triggered, pain in left foot and massive headache all happened within minutes.  Went home after 45 mins.  Temperature dropped to 95 degrees and it took 3 hrs & many layers of clothes to warm up.  Arm became very painful within a couple hours.  Hurt to move or use for 2 days.  2nd day the headache continued, as did the increased tremors.  Ran a 99.9 fever for a few hours, then temp dropped to 95 degrees in evening.  This has continued every evening since.  On the 3rd day a rash developed on the injection shoulder.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site pain, Myalgia
Clinical narrative: Site: Pain at Injection Site-Medium, Additional Details: Husband called to say that she was still having a burning sensation and pain at the injection site a month later. He said the pain is not in the joint, but rather squarely in the mass of her deltoid muscle.  They were encouraged to see a doctor, however, he said they did not plan on seeing one.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Joint injury, Limb injury, Pain, Paraesthesia, Product administration error
Clinical narrative: Error: Shoulder Joint Injury (prolonged pain, tingling, etc.)-
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Eye swelling, Mouth swelling, Skin swelling, Swelling face
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient went to the ER on 01/172022 for a burning sensation and puffy face.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue
Clinical narrative: Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Medium, Additional Details: Patient went to the ER on 01/172022 for a burning sensation and puffy face.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Mass, Pain in extremity, Peripheral swelling
Clinical narrative: Big Lump under left arm. Swollen and painful; Big Lump under left arm. Swollen and painful; Big Lump under left arm. Swollen and painful; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Dec2021 (Lot number: 33030bd) at the age of 40 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Previous dose product: COVID 19, Previous dose brand: Pfizer , Previous dose brand unknown: False, Previous dose lot unknown: True, Previous dose lot unknown reason: Misplaced/discarded, Previous dose dose number: 2, Previous dose vaccine location: Left arm), for Covid-19 Immunization; Bnt162b2 (Previous dose product: COVID 19, Previous dose brand: Pfizer, Previous dose brand unknown: False, Previous dose lot number: 33030BD, Previous dose lot unknown: False, Previous dose dose number: 1, Previous dose vaccine location=Left arm), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 29Dec2021, outcome "unknown", described as "Booster"; MASS (non-serious), PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 02Jan2022, outcome "not recovered" and all described as "Big Lump under left arm. Swollen and painful". Therapeutic measures were not taken as a result of mass, peripheral swelling, pain in extremity.  Additional Information: other vaccine in four weeks reported as no. Ae resulted in reported as none of the above. covid prior vaccination and covid tested post vaccination reported as no.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Lymph node pain, Lymphadenopathy, Mobility decreased, Sleep disorder
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Lymph Node Swelling-Severe, Additional Details: patient described having a large goose egg form under his arm/armpit that was extremely painful and prevent him from puting his arm down and kept him from sleep for 2 nights
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Asthenia, Chest discomfort, Chest pain, Chills
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: neck swelling-Medium, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Weakness-Medium
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Hypertension, Hypoaesthesia, Injection site bruising
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: neck swelling-Medium, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Weakness-Medium
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nausea, Pain
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: neck swelling-Medium, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Weakness-Medium
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Medium, Systemic: Abdominal Pain-Mild, Systemic: Body Aches Generalized-Medium, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Chills-Severe, Systemic: Diarrhea-Mild, Systemic: Dizziness / Lightheadness-Medium, Systemic: neck swelling-Medium, Systemic: Hypertension-Mild, Systemic: Nausea-Mild, Systemic: Numbness (specify: facial area, extremities)-Mild, Systemic: Weakness-Medium
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site pain, Musculoskeletal discomfort
Clinical narrative: Site: Pain at Injection Site-Mild, Additional Details: discomfort in shoulder lasting weeks after injection, but felt immediately at injection time that something was wrong. discomfort doesn't limit range of motion, no tingling or numbness. dr advised him it might take several weeks or mothns to go away. no further follow up at this time.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Blood pressure abnormal, Chills, Dizziness
Clinical narrative: Systemic: Chills-Medium, Systemic: Dizziness / Lightheadness-Medium, Additional Details: Patient reporting having chills about 5 minutes post-booster injection. Emergency medical services (911) were dispatched. Upon arrival of the paramedics, patient's blood pressure stabilized and patient refused to be transported to the hospital. Followed up with the patient via telephone ~1 hour post-adverse event and the patient reported to be feeling better.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administration error
Clinical narrative: Error: Booster Given Too Early-
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Nausea-Mild, Additional Details: Fainted, came to immediately, sat for 10 minutes, drank water, then felt fine, paramedics cleared her
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: neuropathy
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Lymphadenopathy, Pain
Clinical narrative: Site: Swelling at Injection Site-Severe, Additional Details: Patient called to state that about 24 hours after immunization she experiencef swelling in lymph nodes in arm pit area along with stabbing pain. Patient is going to follow up with PCP
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High-
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect product formulation administered, Interchange of vaccine products, Product administration error
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Error: Booster Given Too Early-
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Error: Wrong Route (SC, IM, etc.)-
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Mild
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypotension
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Hypotension-Medium
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Dizziness, Nausea, Vomiting
Clinical narrative: Systemic: Abdominal Pain-Mild, Systemic: Dizziness / Lightheadness-Mild, Systemic: pt vomited 2 or 3 times but felt better after resting in chair. left after about 30min. tried to call at 8pm that night and no answer-Mild, Systemic: Nausea-Mild, Systemic: Vomiting-Mild, Additional Details: tried to call parents after and no answer but pt seemed fine after he threw up. he might have been a little nervous or scared from the shot
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Muscle contracture, Paraesthesia
Clinical narrative: Tingling/contraction like pains in chest, shortness of breath.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error, Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 20.0
Sex: M
Vaccine: COVID19
Symptoms: Product administration error, Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Product administration error
Clinical narrative: Error: Patient Too Young for Vaccine Administered-
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis, Skin warm, Syncope
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Medium, Additional Details: PATIENT GIVEN VACCINE AND 13 MINUTES INTO THE WAITING PERIOD AFTER ADMINISTRATION PATIENT FELT FAINT. HE WAS WARM TO TOUCH AND WAS HAVING DIFFICULTY WITH HIS VISION. PATIENT DID NOT FALL TO GROUND OR HIT HEAD. AMBULANCE WAS CALLED AND PATIENT WAS ABLE TO WALK OUT WITH NO ISSUES.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Visual Changes/Disturbances-Medium, Additional Details: PATIENT GIVEN VACCINE AND 13 MINUTES INTO THE WAITING PERIOD AFTER ADMINISTRATION PATIENT FELT FAINT. HE WAS WARM TO TOUCH AND WAS HAVING DIFFICULTY WITH HIS VISION. PATIENT DID NOT FALL TO GROUND OR HIT HEAD. AMBULANCE WAS CALLED AND PATIENT WAS ABLE TO WALK OUT WITH NO ISSUES.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Mechanical urticaria, Urticaria
Clinical narrative: She noted a flare in her urticaria and also onset of dermatographic urticaria 11 days after she received her third dose of Moderna mRNA COVID-19 vaccine which led her to present to the ER where she received treatment with H1 and H2 antihistamines and prednisone.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: Site: Pain at Injection Site-Severe
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Systemic: Lymph Node Swelling-Medium, Additional Details: per patient; lymph nodes swollen: armpit, shoulder, neck
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Acne, Rash
Clinical narrative: Systemic: acne like rash on scalp-Mild, Additional Details: Patient complained about getting acne on his scalp which has only occurred after receiving vaccine.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Hyperhidrosis, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Medium
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hypotension, Syncope, Unresponsive to stimuli, Visual impairment
Clinical narrative: Systemic: Dizziness / Lightheadness-Medium, Systemic: Fainting / Unresponsive-Medium, Systemic: Hypotension-Medium, Systemic: Visual Changes/Disturbances-Medium, Additional Details: 10 minutes post vaccination, BP 68/39, HR 50, pulse ox 100%. Visual changes noted. EMS called. 15 minutes post vaccination, BP not improved, pulse ox 68%. EMS arrived and after roughly 15 minutes of EMS monitoring, patient's symptoms had resolved and EMS cleared him for discharge
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site pain, Loss of personal independence in daily activities, Pain in extremity, Paraesthesia
Clinical narrative: Site: Pain at Injection Site-Severe, Systemic: Numbness (specify: facial area, extremities)-Medium, Systemic: Tingling (specify: facial area, extemities)-Medium, Additional Details: patient came in to get booster and said she has been having pain, numbness and tingling in her left arm since she got the 2nd covid vaccine and through all vaccines since. she wanted to get the booster to prevent covid but mentioned that it was sore and achey the days following the vaccine and it has slowly gotten worse and it affects her daily life. She does not have a primary care doctor, I encouraged her to go to urgent care.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lethargy, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Exhaustion / Lethargy-Mild, Systemic: Fainting / Unresponsive-Mild
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Cellulitis, Chest discomfort, Chest pain, Injection site erythema
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: Pt reported that she had severe neck and shoulder pain the day after the 2nd Moderna vaccine. Also reported a swollen right arm. She went to ER on 1/11/22 where she was given doxycycline and benedryl for a diagnosis of cellulitis. Pt has another appointment on 1/14/22 with a doctor regarding existing chest tightness,.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site swelling, Neck pain, Peripheral swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Additional Details: Pt reported that she had severe neck and shoulder pain the day after the 2nd Moderna vaccine. Also reported a swollen right arm. She went to ER on 1/11/22 where she was given doxycycline and benedryl for a diagnosis of cellulitis. Pt has another appointment on 1/14/22 with a doctor regarding existing chest tightness,.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: C-reactive protein, Chest pain, Echocardiogram, Electrocardiogram abnormal, Full blood count
Clinical narrative: chest pain  elevated cardiac enzymes abnormal EKG myocarditis
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Metabolic function test, Myocardial necrosis marker increased, Myocarditis, Prohormone brain natriuretic peptide, Red blood cell sedimentation rate
Clinical narrative: chest pain  elevated cardiac enzymes abnormal EKG myocarditis
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Troponin
Clinical narrative: chest pain  elevated cardiac enzymes abnormal EKG myocarditis
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect product formulation administered
Clinical narrative: Error: Wrong Vaccine Formulation  (ex. different manufact. initial and booster)-
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Pancreatitis
Clinical narrative: Systemic: Abdominal Pain-Mild, Systemic: Pancreatitis-Mild, Additional Details: Pt stated she got diagnosed with pancreasetits a few months after recieving covid vaccine. told her not a reported side effects but would submit a VAERS in case patterns are discovered. Told patient to let md know when she had her covid shot as well.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Muscle swelling, Neuralgia
Clinical narrative: Site: Pain at Injection Site-Severe, Additional Details: "popeye muscle" and intense nerve pain in left arm for the past 6 months - has still not recovered.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; Pneumovax 23 Syringe 01-OCT-2015  and 10-OCT-2019; This spontaneous report was received from an 66 year old female patient, concerning to herself from a case in litigation for zoster vaccine live (ZOSTAVAX) (1902USA008671). The patient's medical history, previous drug reactions or allergies and concomitant medications were not reported.  On  01-OCT-2015, the patient was vaccinated with Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) for prophylaxis (strength, dose, route of administration, anatomical location, lot # and expiration date were not provided). It was reported that another doses of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) was administered  ON 10-OCT-2019 (inappropriate schedule of product administration).  This is one of two reports received from the same patient. ; Sender's Comments:  US-009507513-1902USA008671:
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: postherpetic neuralgia/severe and permanent personal injuries; suffered multiple outbreaks of herpes zoster/severe and permanent personal injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation and referring to a female patient (pt) of unknown age. Information about concurrent conditions, medical history and concomitant medications was not reported. On an unknown date, the pt was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, anatomical location, lot # and expiration date were not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). On an unknown date after receiving the vaccine, the pt suffered multiple outbreaks of herpes zoster and postherpetic neuralgia. As a result of these symptoms, the pt was seen and treated by medical providers and still has been under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt's symptoms had resulted in physical limitations not present prior to using the vaccine. The pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of the pt's condition. As a result of the zoster vaccine live (ZOSTAVAX), the pt sustained severe and permanent personal injuries. Further, as a tragic consequence of the vaccine, the pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of herpes zoster and post herpetic neuralgia was not recovered. The reporter considered herpes zoster and postherpetic neuralgia to be related to zoster vaccine live (ZOSTAVAX).   The events herpes zoster and post herpetic neuralgia were considered to be disabling.
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Had not experienced any adverse effects; PEDVAXHIB administered on 16-NOV-2021 and second dose administered; administered expired PEDVAXHIB; PEDVAXHIB/35-year-old; This spontaneous report was received from a pharmacist concerning a 35-years-old female patient. Patient's concurrent condition, medical history and concomitant medications were not provided.  On 16-NOV-2021, the patient was vaccinated with an expired dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot number S000354 with expiration date on 18-OCT-2021 for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided) (expired product administered/product administered to patient of inappropriate age).  On 16-DEC-2021, the patient was vaccinated with a second unaffected dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) batch number reported as U0144484 with expiration date reported as 15-SEP-2023 for prophylaxis (strength, dose, frequency, route of administration and anatomical location were not provided) (inappropriate schedule of product administration).  It was reported that the patient was fine and had not experienced any adverse effects.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: No additional adverse events reported; missed dose of ROTATEQ; This spontaneous report was received from a medical assistant referring to a 9 month old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 2 milliliter for prophylaxis (strength, formulation, route of administration, vaccination scheme frequency, lot number and expiration date were not reported).   On 22-OCT-2021, the 9 month 2 day old patient missed a dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (product dose omission issue). No additional adverse events reported.
Age: 1.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No adverse reaction; Expired dose of MMR II that was administered; This spontaneous report was received from a nurse referring to a currently 12-month-old patient of unknown gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 13-JAN-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, Live recombinant human albumin (rHA) (M-M-R II) (dose 1, lot # T001214 and expiration date 12-JAN-2022), 0.5 milliliter, subcutaneous for prophylaxis (expired product administered).
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AEs reported; Expired MMR II vaccine administered; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. Patient's concurrent conditions, medical history and concomitant medications were not provided.  On 13-JAN-2022, the patient was vaccinated with expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, Live recombinant human albumin (rHA) (M-M-R II) (lot # T001214 and expiration date 12-JAN-2022), 0.5 milligram, subcutaneous for prophylaxis (expired product administered).
Sex: M
Vaccine: VARCEL
Symptoms: Blister, Nasopharyngitis, Pityriasis rosea, Rash, Varicella
Clinical narrative: pityriasis rosea; cold; viral infection; This spontaneous report was received from a consumer via company representative, referring to her son of unknown age.   No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.   On an unknown date, the patient received 2 doses of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).          On 14-JAN-2022, the patient was seen by pediatrician since it was noted to have vesicles with suspect chicken pox.  The patient was diagnosed pityriasis rosea (pityriasis rosea). The patient also had a cold/virus (nasopharyngitis) the previous week so rash was said to be post viral infection (viral infection).  The outcome of the events and the causal relationship between the events and therapy with varicella virus vaccine live (oka/merck) (VARIVAX) were not reported.
Sex: M
Vaccine: VARCEL
Symptoms: Viral infection
Clinical narrative: pityriasis rosea; cold; viral infection; This spontaneous report was received from a consumer via company representative, referring to her son of unknown age.   No information was provided regarding the patient's medical history, concurrent conditions, past drug history or concomitant medications.   On an unknown date, the patient received 2 doses of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported).          On 14-JAN-2022, the patient was seen by pediatrician since it was noted to have vesicles with suspect chicken pox.  The patient was diagnosed pityriasis rosea (pityriasis rosea). The patient also had a cold/virus (nasopharyngitis) the previous week so rash was said to be post viral infection (viral infection).  The outcome of the events and the causal relationship between the events and therapy with varicella virus vaccine live (oka/merck) (VARIVAX) were not reported.
Age: 1.08
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE reported; MMR II and VARIVAX that had undergone temperature excursion were administered; This spontaneous report was received from a nurse referring to a currently 13-month-old male patient. The patient's current condition, pertinent medical history and concomitant therapy were not reported.  On 14-JAN-2022, date the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (Lot # T031436 and expiration date upon internal validation was 15-SEP-2022) and varicella virus vaccine live (oka/merck)(VARIVAX) (Lot # U015845 and expiration date reported as 19-MAY-2023) that had undergone temperature excursion for prophylaxis (Product storage error). No additional AE reported. No PQC reported.
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Pneumonia
Clinical narrative: pneumonia symptoms; sore arm; This spontaneous report has been received from lawyer from a case in litigation for zoster vaccine live (ZOSTAVAX) (1810USA004176), concerning a currently 68-year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On an unspecified date in 2006, she was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (reported as "pneumonia") (manufacturer unknown) as prophylaxis (strength, dose, route of administration, anatomical location, lot number, and expiration date were not reported). Afterwards, on unknown dates, she experienced sore arm (pain in extremity) and pneumonia symptoms (pneumonia). The outcome of of both events was unknown. The causality assessment between pain in extremity and pneumonia, and the vaccine were not provided.  Upon internal review, the event pneumonia was determined to be medically significant.  This is one of two reports concerning the same patient.; Sender's Comments:  US-009507513-1810USA004176:
Sex: F
Vaccine: COVID19, UNK
Symptoms: Dehydration, Rheumatoid arthritis
Clinical narrative: This serious solicited report (USASL2022002347) was reported on 07/JAN/2022 by a consumer from a commercial program (PSP00086) and involves a 56 year old female patient who did not feel well/ vaccination made her RA (rheumatoid arthritis) worse/pigmentation/dry eye [PT: rheumatoid arthritis], dehydration [PT: dehydration] while receiving Enbrel with Single Dose Prefilled Autoinjector. No historical medical condition was reported. The patient's current medical condition included rheumatoid arthritis. No concomitant medications were provided. The patient's co-suspect medication included COVID-19 Vaccine. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. The patient states on an unknown date, she went for her eye exam the physician asked if she had rheumatoid arthritis. He states could tell because dry eyes and pigmentation that can be related to the rheumatoid arthritis or auto immune issues and dehydration. She also reports that she had the Covid vaccination, the first one went fine but she did not feel well after the second one. Since then she was not at the top of her game with energy and activity. She really does not take the booster because she feels the vaccination made her rheumatoid arthritis worse then it was been in a while and Enbrel had been a life changer for her. No treatment information was received. The outcome of the events rheumatoid arthritis, dehydration were reported as unknown. Action taken with Enbrel and Single Dose Prefilled Autoinjector was reported as unknown for the events dehydration and rheumatoid arthritis. The causal relationship between the events dehydration, rheumatoid arthritis and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. Comment: This individual case report does not change the safety profile of the product. Causality Assessment for Rheumatoid arthritis aggravated, Dehydration Per Company (Amgen): not related. The reporter's assessment of the causal relationship of the events with the suspect products was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment. Etanercept (ENBREL) is under agreement with RA. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected. Sender's Comments: The reported event of RA aggravated was assessed as possibly related to BNT162B2. The event dehydration is likely intercurrent and is not related with vaccine used. The events RA aggravated and Dehydration were unrelated with etanercept use.