chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Hot flush, Increased viscosity of bronchial secretion, Lung disorder, Pharyngeal swelling
Clinical narrative: 9-10min after getting the shot, my lungs felt like I was running a marathon; chest pain; my ears and face flushed red & hot; my ears and face flushed red & hot; coughing; choking; couldn't breathe; My throat was swelling up so fast and filling with a thick mucous; My throat was swelling up so fast and filling with a thick mucous; she was not coherent enough to remember it; This is a spontaneous report from a contactable consumer (patient).   A 33-year-old female patient received the 1st dose of bnt162b2 (BNT162B2) at single dose at left arm on 17Feb2021 15:00 for Covid-19 immunisation, administered at hospital. Medical history included asthma, gastrooesophageal reflux disease (GERD), endometriosis, adenomyosis, polycystic ovaries (PCOS), anaphylactic reaction Known allergies: fried chicken/fast food unknown preservative (anaphylactic). Patient was not pregnant. The patient had not experienced Covid-19 prior vaccination. Concomitant medication in 2 weeks included: levonorgestrel (MIRENA), omeprazole (OMEPRAZOLE), paracetamol (TYLENOL). No other vaccine in 4 weeks. The patient previously took cyclobenzaprine and experienced dust allergy, metronidazole and experienced drug hypersensitivity, cephalexin and experienced drug hypersensitivity, tramadol and experienced anaphylactic reaction.   On 17Feb2021 03:15 PM, 9-10 min after getting the shot, her lungs felt like she was running a marathon. She told the observer and before she finished describing her chest pain, her ears and face flushed red & hot. She called for a stretcher and she started coughing. They got her on a stretcher & ran her to the ER down the hallway. She was coughing and choking and couldn't breathe. Her throat was swelling up so fast and filling with a thick mucous. Patient received treatment with an epinephrine shot, solumedrol shot, Benadryl shot & started an iv steroid that started with a V sound (between choking/epinephrine/Benadryl, she was not coherent enough to remember it). Within a few minutes her coughing subsided and she was able to breathe normally. She received an albuterol treatment at that point. She was kept under observation for 5 hours. At about the 4 hour mark she had another albuterol treatment. She has continued albuterol treatments every 4 hrs. Oral Prednisone, oral Benadryl. It's hills immediately after meds, valleys between. Patient was not tested for covid post vaccination. AEs resulted in: doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care, Life threatening illness (immediate risk of death from the event. Reactions were ongoing. The outcome of events was recovering.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus, Tryptase, Urticaria
Clinical narrative: This 21 yo corpsman advised 1/15/2021 she received her first COVID Pfizer vaccine with complaints of elev heart rate sensation and feeling hot immediately after her first COVID vaccine that did resolve within a few moments on it's own.  She reports a sore, red, hot are at injection site that lasted for 3-4 days and resolved on own.  She reported being in good health until mid February when she noticed sinus/facial pressure, nasal congestion w/nasal voice (no throat issues, just nasal muffling).  She denied any fever, sob, cp, rash, ha, or other systemic symptoms and a HCP placed her on Augmentin.  She completed her AB on 2/20, 2 days before her 2nd covid vaccine.   -------  On 2/22/2021 she received her 2nd Pfizer Covid vaccine to left arm and went back to ER (where she works) for observation.  She reported she again had sense of elevated heart rate, feeling hot and now itched all over (now about 30 min post vaccine).  She reported symptoms to RN who noted onset of "hives" to midthoracic area on her back and recommended she be seen by ER.  She was treated by ER MD approximately 1 hour post vaccination with MD noting a 1x1cm red raised hive to T1 region on back and no other lesions or skin rashes.  She denied any SOB, cp, ha, fever, difficult swallowing-speaking, no oral swelling, no angioedema, no recent exposures-insect bites, no new food groups, soaps, detergents, lotions, cloths, etc.  She was treated with I liter NS bolus, IV Benadryl, Solu-Medrol, and Pepcid.  HR was 81 w/rr 16 and 100% O2 sats on arrival.  Afebrile.  She was released home on Prednisone, pepcid, atarax, and prn benadryl.  ----- On 2/14/2021 follow up, she advised hive has resolved, she still feels itchy on and off but not taking any medications.  She c/o "weird ringing sensation to bilateral ears described as a muffled sensation with some pressure.  Again s/s similar to previous sinus infection except for ringing sensation.  She also has a sore site, again to left arm that looks bruised and is still warm to touch (no swelling, less redness vs 2 days ago).    She reports a similar red flushed vaccine site when 13 yo and receipt of first HPV vaccine (name, lot #, details unknown).  She does not recall any other s/s except her mother said she was not going to get the rest of the series.  Since then she has had a "nodule" in her left deltoid.  She has received many other vaccines to both deltoids w/o issues.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Discomfort, Erythema, Feeling hot, Heart rate increased
Clinical narrative: This 21 yo corpsman advised 1/15/2021 she received her first COVID Pfizer vaccine with complaints of elev heart rate sensation and feeling hot immediately after her first COVID vaccine that did resolve within a few moments on it's own.  She reports a sore, red, hot are at injection site that lasted for 3-4 days and resolved on own.  She reported being in good health until mid February when she noticed sinus/facial pressure, nasal congestion w/nasal voice (no throat issues, just nasal muffling).  She denied any fever, sob, cp, rash, ha, or other systemic symptoms and a HCP placed her on Augmentin.  She completed her AB on 2/20, 2 days before her 2nd covid vaccine.   -------  On 2/22/2021 she received her 2nd Pfizer Covid vaccine to left arm and went back to ER (where she works) for observation.  She reported she again had sense of elevated heart rate, feeling hot and now itched all over (now about 30 min post vaccine).  She reported symptoms to RN who noted onset of "hives" to midthoracic area on her back and recommended she be seen by ER.  She was treated by ER MD approximately 1 hour post vaccination with MD noting a 1x1cm red raised hive to T1 region on back and no other lesions or skin rashes.  She denied any SOB, cp, ha, fever, difficult swallowing-speaking, no oral swelling, no angioedema, no recent exposures-insect bites, no new food groups, soaps, detergents, lotions, cloths, etc.  She was treated with I liter NS bolus, IV Benadryl, Solu-Medrol, and Pepcid.  HR was 81 w/rr 16 and 100% O2 sats on arrival.  Afebrile.  She was released home on Prednisone, pepcid, atarax, and prn benadryl.  ----- On 2/14/2021 follow up, she advised hive has resolved, she still feels itchy on and off but not taking any medications.  She c/o "weird ringing sensation to bilateral ears described as a muffled sensation with some pressure.  Again s/s similar to previous sinus infection except for ringing sensation.  She also has a sore site, again to left arm that looks bruised and is still warm to touch (no swelling, less redness vs 2 days ago).    She reports a similar red flushed vaccine site when 13 yo and receipt of first HPV vaccine (name, lot #, details unknown).  She does not recall any other s/s except her mother said she was not going to get the rest of the series.  Since then she has had a "nodule" in her left deltoid.  She has received many other vaccines to both deltoids w/o issues.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Pain, Pruritus, Skin warm, Tinnitus
Clinical narrative: This 21 yo corpsman advised 1/15/2021 she received her first COVID Pfizer vaccine with complaints of elev heart rate sensation and feeling hot immediately after her first COVID vaccine that did resolve within a few moments on it's own.  She reports a sore, red, hot are at injection site that lasted for 3-4 days and resolved on own.  She reported being in good health until mid February when she noticed sinus/facial pressure, nasal congestion w/nasal voice (no throat issues, just nasal muffling).  She denied any fever, sob, cp, rash, ha, or other systemic symptoms and a HCP placed her on Augmentin.  She completed her AB on 2/20, 2 days before her 2nd covid vaccine.   -------  On 2/22/2021 she received her 2nd Pfizer Covid vaccine to left arm and went back to ER (where she works) for observation.  She reported she again had sense of elevated heart rate, feeling hot and now itched all over (now about 30 min post vaccine).  She reported symptoms to RN who noted onset of "hives" to midthoracic area on her back and recommended she be seen by ER.  She was treated by ER MD approximately 1 hour post vaccination with MD noting a 1x1cm red raised hive to T1 region on back and no other lesions or skin rashes.  She denied any SOB, cp, ha, fever, difficult swallowing-speaking, no oral swelling, no angioedema, no recent exposures-insect bites, no new food groups, soaps, detergents, lotions, cloths, etc.  She was treated with I liter NS bolus, IV Benadryl, Solu-Medrol, and Pepcid.  HR was 81 w/rr 16 and 100% O2 sats on arrival.  Afebrile.  She was released home on Prednisone, pepcid, atarax, and prn benadryl.  ----- On 2/14/2021 follow up, she advised hive has resolved, she still feels itchy on and off but not taking any medications.  She c/o "weird ringing sensation to bilateral ears described as a muffled sensation with some pressure.  Again s/s similar to previous sinus infection except for ringing sensation.  She also has a sore site, again to left arm that looks bruised and is still warm to touch (no swelling, less redness vs 2 days ago).    She reports a similar red flushed vaccine site when 13 yo and receipt of first HPV vaccine (name, lot #, details unknown).  She does not recall any other s/s except her mother said she was not going to get the rest of the series.  Since then she has had a "nodule" in her left deltoid.  She has received many other vaccines to both deltoids w/o issues.
Age: 21.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: This 21 yo corpsman advised 1/15/2021 she received her first COVID Pfizer vaccine with complaints of elev heart rate sensation and feeling hot immediately after her first COVID vaccine that did resolve within a few moments on it's own.  She reports a sore, red, hot are at injection site that lasted for 3-4 days and resolved on own.  She reported being in good health until mid February when she noticed sinus/facial pressure, nasal congestion w/nasal voice (no throat issues, just nasal muffling).  She denied any fever, sob, cp, rash, ha, or other systemic symptoms and a HCP placed her on Augmentin.  She completed her AB on 2/20, 2 days before her 2nd covid vaccine.   -------  On 2/22/2021 she received her 2nd Pfizer Covid vaccine to left arm and went back to ER (where she works) for observation.  She reported she again had sense of elevated heart rate, feeling hot and now itched all over (now about 30 min post vaccine).  She reported symptoms to RN who noted onset of "hives" to midthoracic area on her back and recommended she be seen by ER.  She was treated by ER MD approximately 1 hour post vaccination with MD noting a 1x1cm red raised hive to T1 region on back and no other lesions or skin rashes.  She denied any SOB, cp, ha, fever, difficult swallowing-speaking, no oral swelling, no angioedema, no recent exposures-insect bites, no new food groups, soaps, detergents, lotions, cloths, etc.  She was treated with I liter NS bolus, IV Benadryl, Solu-Medrol, and Pepcid.  HR was 81 w/rr 16 and 100% O2 sats on arrival.  Afebrile.  She was released home on Prednisone, pepcid, atarax, and prn benadryl.  ----- On 2/14/2021 follow up, she advised hive has resolved, she still feels itchy on and off but not taking any medications.  She c/o "weird ringing sensation to bilateral ears described as a muffled sensation with some pressure.  Again s/s similar to previous sinus infection except for ringing sensation.  She also has a sore site, again to left arm that looks bruised and is still warm to touch (no swelling, less redness vs 2 days ago).    She reports a similar red flushed vaccine site when 13 yo and receipt of first HPV vaccine (name, lot #, details unknown).  She does not recall any other s/s except her mother said she was not going to get the rest of the series.  Since then she has had a "nodule" in her left deltoid.  She has received many other vaccines to both deltoids w/o issues.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood potassium decreased, Blood sodium decreased, Dizziness, Dry mouth, Dyspnoea
Clinical narrative: Roughly 30 minutes after administration of vaccine patient endorsed weakness, dizziness and shortness of breath.  His blood pressure and heart rate increased during the event.  He was treated with epinephrine 0.3mg IM due to concern for anaphylaxis and transferred to the ER via EMS.  In the ER his vitals were stable and he was observed in the ER for 3 hours, with improvement in his symptoms.  During the course of his stay he was treated with Benadryl, dexamethasone and albuterol.  He presented with no hives, pharyngeal edema, wheezing, hypoxia or nausea/vomiting/diarrhea.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Troponin normal, White blood cell count normal
Clinical narrative: Roughly 30 minutes after administration of vaccine patient endorsed weakness, dizziness and shortness of breath.  His blood pressure and heart rate increased during the event.  He was treated with epinephrine 0.3mg IM due to concern for anaphylaxis and transferred to the ER via EMS.  In the ER his vitals were stable and he was observed in the ER for 3 hours, with improvement in his symptoms.  During the course of his stay he was treated with Benadryl, dexamethasone and albuterol.  He presented with no hives, pharyngeal edema, wheezing, hypoxia or nausea/vomiting/diarrhea.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood pressure increased, Blood sodium decreased, Chest X-ray normal, Dizziness
Clinical narrative: Roughly 30 minutes after administration of vaccine patient endorsed weakness, dizziness and shortness of breath.  His blood pressure and heart rate increased during the event.  He was treated with epinephrine 0.3mg IM due to concern for anaphylaxis and transferred to the ER via EMS.  In the ER his vitals were stable and he was observed in the ER for 3 hours, with improvement in his symptoms.  During the course of his stay he was treated with Benadryl, dexamethasone and albuterol.  He presented with no hives, pharyngeal edema, wheezing, hypoxia or nausea/vomiting/diarrhea.
Age: 45.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Heart rate increased, Troponin normal
Clinical narrative: Roughly 30 minutes after administration of vaccine patient endorsed weakness, dizziness and shortness of breath.  His blood pressure and heart rate increased during the event.  He was treated with epinephrine 0.3mg IM due to concern for anaphylaxis and transferred to the ER via EMS.  In the ER his vitals were stable and he was observed in the ER for 3 hours, with improvement in his symptoms.  During the course of his stay he was treated with Benadryl, dexamethasone and albuterol.  He presented with no hives, pharyngeal edema, wheezing, hypoxia or nausea/vomiting/diarrhea.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Borrelia test negative, Ear discomfort, Facial paralysis, Lacrimation increased
Clinical narrative: PT reports vaccine on a Tuesday morning at 930, at 6PM> 9 hours after injection L ear fullness/pain/pressure. Wednesday, L eye watery and pain behind L ear. Thursday dribbled when drinking water when working overnight shift. upon awakening Friday afternoon, speech was "off" noted L side of face drooped and unable to close L eye. went to Urgent care and referred to ED for suspected stroke due to High BP> member stopped HTN meds 8/2020. Seen at Holy Redeemer Hospital ED and dx Bell's palsy. now on steroids, eye ointment and metoprolol.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Barotrauma, Drooling, Dysarthria, Ear pain, Facial paralysis
Clinical narrative: PT reports vaccine on a Tuesday morning at 930, at 6PM> 9 hours after injection L ear fullness/pain/pressure. Wednesday, L eye watery and pain behind L ear. Thursday dribbled when drinking water when working overnight shift. upon awakening Friday afternoon, speech was "off" noted L side of face drooped and unable to close L eye. went to Urgent care and referred to ED for suspected stroke due to High BP> member stopped HTN meds 8/2020. Seen at Holy Redeemer Hospital ED and dx Bell's palsy. now on steroids, eye ointment and metoprolol.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hypoacusis, Hypoaesthesia oral, Lacrimation increased, Lagophthalmos
Clinical narrative: PT reports vaccine on a Tuesday morning at 930, at 6PM> 9 hours after injection L ear fullness/pain/pressure. Wednesday, L eye watery and pain behind L ear. Thursday dribbled when drinking water when working overnight shift. upon awakening Friday afternoon, speech was "off" noted L side of face drooped and unable to close L eye. went to Urgent care and referred to ED for suspected stroke due to High BP> member stopped HTN meds 8/2020. Seen at Holy Redeemer Hospital ED and dx Bell's palsy. now on steroids, eye ointment and metoprolol.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cytokine test, Dyspnoea, Full blood count, Laboratory test, Lip swelling
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test, Palpitations, SARS-CoV-2 antibody test, Swollen tongue
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Discomfort, Pain
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chest discomfort, Discomfort, Dysphagia, Dyspnoea
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye swelling, Fatigue, Lethargy, Mouth swelling, Pain
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling face, Swollen tongue, Tachycardia, Throat tightness, Tremor
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cytokine test, Dyspnoea, Full blood count, Laboratory test, Lip swelling
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Metabolic function test, Palpitations, SARS-CoV-2 antibody test, Swollen tongue
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Discomfort, Pain
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Chest discomfort, Discomfort, Dysphagia, Dyspnoea
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye swelling, Fatigue, Lethargy, Mouth swelling, Pain
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Swelling face, Swollen tongue, Tachycardia, Throat tightness, Tremor
Clinical narrative: Systemic: Allergic: Anaphylaxis-Severe, Systemic: Allergic: Difficulty Breathing-Severe, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Severe, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Chest Tightness / Heaviness / Pain-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: epipen was administered at 1:02 PM by, benadryl 50 mg po, and O2 inhalation, and patient was transported to ED at 1:08 PM. patient was given a second dose of epipen in the ambulance and at 2:48 PM, patient is stable and improving-Severe, Systemic: Shakiness-Severe, Systemic: Tachycardia-Severe, Systemic: Weakness-Severe, Additional Details: at 12:20 PM, recieved the pfizer bointech covid vaccine- 1st dose. lot:el9269 exp:05/21 which was mixed by employee and injected by employee. prior to getting the vaccine, patient told employee that she recueves cortisone injections in her elbow, unknown frequency, and due for her next injection on the following day 02-24-2021 and employee told her that she can double check with her doctor and consented to recieving the vaccine. at 12:30 PM
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Fever, acute hypoxic respiratory failure, altered mental status
Age: 86.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Mental status changes, Pyrexia, Respiratory failure
Clinical narrative: Fever, acute hypoxic respiratory failure, altered mental status
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low
Age: 35.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Underdose
Clinical narrative: Error: Wrong Dose of Vaccine - Too Low
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Eye swelling, Rash erythematous
Clinical narrative: Hives/swelling/puritis (of head/face, neck, chest, arms) and elevated blood pressure. IM Benadryl at vaccination site IM steroid and prescription for steroids in ED
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Pruritus, Swelling, Urticaria
Clinical narrative: Hives/swelling/puritis (of head/face, neck, chest, arms) and elevated blood pressure. IM Benadryl at vaccination site IM steroid and prescription for steroids in ED
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Fatigue
Clinical narrative: Patient received vaccine on 2/13/21 and on 2/14/21 started to notice he felt very tired and then developed to severe fatigue when patient was seen virtually by the clinic on 2/28/21. Patient has had a negative PCR test and no otherreason noted for fatigue.
Age: 66.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Fatigue, Laboratory test, Polymerase chain reaction
Clinical narrative: Patient received vaccine on 2/13/21 and on 2/14/21 started to notice he felt very tired and then developed to severe fatigue when patient was seen virtually by the clinic on 2/28/21. Patient has had a negative PCR test and no otherreason noted for fatigue.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tryptase, Urticaria
Clinical narrative: Within 5 minutes of receiving vaccine, patient developed purplish hands, red blotches on her arms, generalized itching. She felt thirsty, dry throat and a little bit of fullness in her throat.  Throat did not actually close.  She felt like she was looking through a fog.  She was given oral zyrtec and IM benadryl. Symptoms resolved.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dry throat, Erythema, Pruritus, Rash macular, Sensation of foreign body
Clinical narrative: Within 5 minutes of receiving vaccine, patient developed purplish hands, red blotches on her arms, generalized itching. She felt thirsty, dry throat and a little bit of fullness in her throat.  Throat did not actually close.  She felt like she was looking through a fog.  She was given oral zyrtec and IM benadryl. Symptoms resolved.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Skin discolouration, Thirst
Clinical narrative: Within 5 minutes of receiving vaccine, patient developed purplish hands, red blotches on her arms, generalized itching. She felt thirsty, dry throat and a little bit of fullness in her throat.  Throat did not actually close.  She felt like she was looking through a fog.  She was given oral zyrtec and IM benadryl. Symptoms resolved.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Hypoaesthesia, Injection site hypersensitivity, Injection site pain, Injection site swelling
Clinical narrative: experienced on her left arm from the injection site to elbow a black and blue swelling; soreness at the injection; Sensitivity at injection site; on the entire right side of the body had a tingling; on the entire right side of the body had a burning sensation/ it was burning; insensitive; right side from the scalp all the way down to her legs had a weird sensation; soreness, sensitivity, and swelling at the injection site that prevented her from sleeping/ Trouble sleeping; experienced on her left arm from the injection site to elbow a black and blue swelling; This case was reported by a pharmacist and described the occurrence of extensive swelling of vaccinated limb in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number DP95H, expiry date 15th April 2022) for prophylaxis.   Previously administered products included Pneumonia vaccine (received on an unknown date), Flu vaccine (received on an unknown date) and TDap vaccine (received on an unknown date).   On 16th June 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 16th June 2020, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site hypersensitivity, tingling, burning sensation skin, numbness, weird feeling, difficulty sleeping and skin discoloration. On 19th June 2020, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site hypersensitivity, tingling, burning sensation skin, numbness, weird feeling, difficulty sleeping and skin discoloration were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site hypersensitivity, tingling, burning sensation skin, numbness, weird feeling, difficulty sleeping and skin discoloration to be related to Shingrix.  Additional details were provided as follows:  The patient had received other vaccines (pneumonia, TDap, and flu) without any problems.  The 1st dose was given in the patient's left arm.  The right side from the scalp all the way down to her legs had a weird sensation. It was burning and tingling. The patient had soreness, sensitivity and swelling at the injection site that prevented her from sleeping, as well as a black and blue discoloration along with swelling of the skin that went from the injection site to the elbow.  These reactions lasted about 3 days, with the second day being the worst.  The reporter consented to follow up. The reporter provided the contact information and did not have an email to provide.; Sender's Comments:  US- GLAXOSMITHKLINE-US2020251615:same reporter
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Paraesthesia, Peripheral swelling, Skin burning sensation, Skin discolouration
Clinical narrative: experienced on her left arm from the injection site to elbow a black and blue swelling; soreness at the injection; Sensitivity at injection site; on the entire right side of the body had a tingling; on the entire right side of the body had a burning sensation/ it was burning; insensitive; right side from the scalp all the way down to her legs had a weird sensation; soreness, sensitivity, and swelling at the injection site that prevented her from sleeping/ Trouble sleeping; experienced on her left arm from the injection site to elbow a black and blue swelling; This case was reported by a pharmacist and described the occurrence of extensive swelling of vaccinated limb in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number DP95H, expiry date 15th April 2022) for prophylaxis.   Previously administered products included Pneumonia vaccine (received on an unknown date), Flu vaccine (received on an unknown date) and TDap vaccine (received on an unknown date).   On 16th June 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 16th June 2020, less than a day after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, injection site pain, injection site hypersensitivity, tingling, burning sensation skin, numbness, weird feeling, difficulty sleeping and skin discoloration. On 19th June 2020, the outcome of the extensive swelling of vaccinated limb, injection site pain, injection site hypersensitivity, tingling, burning sensation skin, numbness, weird feeling, difficulty sleeping and skin discoloration were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, injection site hypersensitivity, tingling, burning sensation skin, numbness, weird feeling, difficulty sleeping and skin discoloration to be related to Shingrix.  Additional details were provided as follows:  The patient had received other vaccines (pneumonia, TDap, and flu) without any problems.  The 1st dose was given in the patient's left arm.  The right side from the scalp all the way down to her legs had a weird sensation. It was burning and tingling. The patient had soreness, sensitivity and swelling at the injection site that prevented her from sleeping, as well as a black and blue discoloration along with swelling of the skin that went from the injection site to the elbow.  These reactions lasted about 3 days, with the second day being the worst.  The reporter consented to follow up. The reporter provided the contact information and did not have an email to provide.; Sender's Comments:  US- GLAXOSMITHKLINE-US2020251615:same reporter
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Delirium, Dysphagia, Night sweats
Clinical narrative: Fever of 101 degrees F that is on and off/100.7 F; Wasn't not able to swallow or eat at all; Severe red sore throat with white points; Very sweaty especially at night; a little bit of delirious; Severe chills where his teeth were chattering; Sore throat/In agony with a sore throat; Sore arm; When he first got the vaccine he said "Boy you can really feel something going on in there"; A spontaneous report was received from a consumer regarding her son, a 30-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a little bit delirious/delirious, sore throat, sore arm/vaccination site pain, chills, fever/pyrexia, when first receiving the vaccine he stated "boy you can really feel something going on in there"/ vaccination site dysathesia, swallowing difficult/dysphagia, severe red sore throat with white points/throat infection, and very sweaty at night/night sweats.  The patient's medical history was not included. Products known to have been used by the patient were Vitamin D3, Creatine monohydrate and Fish Oil.  On 11 January 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.    On 12 January 2021, the patient reported a sore throat, and sore arm, took 2 ibuprofen, which patient reported as helped.  On 14 January 2021, the patient reported chills, sore throat in agony with sore throat, and fever. Patient took ibuprofen, which he reported as helping and was able to sleep. The soreness in the arm was reported as gone.  On 17 January 2021, the patient's mother reported he was still having fever and was a little bit delirious.   On 18 January 2021, the patient reported fever, sweaty at night, severe red sore throat with white points, unable to eat or swallow. Treatment information included ibuprofen every 6 hours, which was reported to not be helping.  Consent to contact was provided.  Action taken with mRNA-1273 was not reported.  The outcome of the event, sore arm, was considered unresolved.  The outcome of the events, sore throat, fever, sweaty at night, severe red sore throat with white points, being unable to eat or swallow, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events , a causal relationship cannot be excluded.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pharyngitis, Pyrexia, Vaccination site dysaesthesia, Vaccination site pain
Clinical narrative: Fever of 101 degrees F that is on and off/100.7 F; Wasn't not able to swallow or eat at all; Severe red sore throat with white points; Very sweaty especially at night; a little bit of delirious; Severe chills where his teeth were chattering; Sore throat/In agony with a sore throat; Sore arm; When he first got the vaccine he said "Boy you can really feel something going on in there"; A spontaneous report was received from a consumer regarding her son, a 30-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a little bit delirious/delirious, sore throat, sore arm/vaccination site pain, chills, fever/pyrexia, when first receiving the vaccine he stated "boy you can really feel something going on in there"/ vaccination site dysathesia, swallowing difficult/dysphagia, severe red sore throat with white points/throat infection, and very sweaty at night/night sweats.  The patient's medical history was not included. Products known to have been used by the patient were Vitamin D3, Creatine monohydrate and Fish Oil.  On 11 January 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 025L20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.    On 12 January 2021, the patient reported a sore throat, and sore arm, took 2 ibuprofen, which patient reported as helped.  On 14 January 2021, the patient reported chills, sore throat in agony with sore throat, and fever. Patient took ibuprofen, which he reported as helping and was able to sleep. The soreness in the arm was reported as gone.  On 17 January 2021, the patient's mother reported he was still having fever and was a little bit delirious.   On 18 January 2021, the patient reported fever, sweaty at night, severe red sore throat with white points, unable to eat or swallow. Treatment information included ibuprofen every 6 hours, which was reported to not be helping.  Consent to contact was provided.  Action taken with mRNA-1273 was not reported.  The outcome of the event, sore arm, was considered unresolved.  The outcome of the events, sore throat, fever, sweaty at night, severe red sore throat with white points, being unable to eat or swallow, were considered unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events , a causal relationship cannot be excluded.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Multiple doses were administered out of vials that had been punctured for more than 6 hours; A spontaneous report was received from a physician concerning approximately 50 patients who received Moderna's COVID-19 vaccine (mRNA-1273) administered from vials that had been punctured more than 6 hours.   The patients' medical history was not provided. Concomitant product use was not provided by the reporter.   Between 24 Dec 2020 and 08 Feb 2021, patients received their first of two planned doses of mRNA-1273 (Batch number 026L20A and 027L20A) intramuscularly for prophylaxis of COVID-19 infection.   Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided/unknown.  The event, vaccine administered from vials that had been punctured more than 6 hours, was considered resolved on 08 Feb 2021.  Treatment, action taken with RNA-1273 in response to the event  and the outcome of the event were unknown; Reporter's Comments: This report refers to a case of expired product administered for mRNA-1273, batch number 027L20A. 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.
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Syringe issue, Underdose
Clinical narrative: Few drops of the dose dripped out as the nurse was administering; vaccine pen was faulty; Received another dose as a result; A spontaneous report was received from a health care professional, concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and reported the patient had received the product and a few drops of the dose dripped out during administration and subsequently received another dose with no associated adverse events.  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 04-FEB-2021, the patient received their second of two planned doses of mRNA-1273 (Lot number:004M20A ) for prophylaxis of COVID-19 infection.  On 04-FEB-2021, during vaccine administration, the vaccine pen was faulty and a few drops of the dose dripped out as the nurse was administering. The patient received another dose as a result. There was no reported adverse events with the product administration error.  No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events, few drops of the dose dripped out as the nurse was administering and received another dose as a result, was considered resolved.; Reporter's Comments: This report refers to a case of vaccine underdose, syringe issue, and extra dose administered for mRNA-1273, lot # 004M20A with no associated AEs.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Chills, Fatigue, Lymphadenopathy
Clinical narrative: Peripheral neuropathy, tingling in arms and feet; Burning sensation in legs; Could not sleep well; Swellng in lymph node on right side; Sore Arm; Fatigue; Chills; Body Aches; Debilitating; A spontaneous report received from Healthcare Professional concerning, 40-year-old female patient who received dose of Moderna COVID-19 vaccine experienced sore arm, fatigue, chills, and body aches. /MedDRA PT: [Sore Arm]   The patient's medical history was not included. Patient's concomitant was not included.    On 05-JAN-2021 date, the patient received their first dose of the two planned doses of mRNA-1273 in right arm (Batch #: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.   Patient who is a Pharmacist received the 1st Moderna vaccine on 05Jan2021 in her right upper arm. Patient stated initially she had a sore arm, fatigue, chills, and body aches. Patient stated 5 days later she had redness and swelling in her lymph node on her right side. Patient stated 10 days later she had peripheral neuropathy and tingling in arms and feet. Patient stated she then developed a burning sensation in her legs. Patient stated that the MD did a full workup on her. Patient stated that all tests came back negative. Patient stated that the MD gave her gabapentin. Patient stated she could not sleep well due to tingling sensation and pain. Patient would like to know if this has been reported. Patient stated today she feels fine. Patient stated this was a scary episode for her and 1st dose of the Moderna COVID-19 vaccine was very debilitating. Patient stated that she has not received the 2nd dose and does not want to receive the 2nd dose of the Moderna COVID 19 vaccine.   Patient was treated with Gabapentin by an MD.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported event, a causal relationship cannot be excluded. Chills fatigue and lymphadenopathy are consistent with the known safety profile of the vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Neuropathy peripheral, Pain, Pain in extremity, Poor quality sleep
Clinical narrative: Peripheral neuropathy, tingling in arms and feet; Burning sensation in legs; Could not sleep well; Swellng in lymph node on right side; Sore Arm; Fatigue; Chills; Body Aches; Debilitating; A spontaneous report received from Healthcare Professional concerning, 40-year-old female patient who received dose of Moderna COVID-19 vaccine experienced sore arm, fatigue, chills, and body aches. /MedDRA PT: [Sore Arm]   The patient's medical history was not included. Patient's concomitant was not included.    On 05-JAN-2021 date, the patient received their first dose of the two planned doses of mRNA-1273 in right arm (Batch #: 011J20A) intramuscularly for prophylaxis of COVID-19 infection.   Patient who is a Pharmacist received the 1st Moderna vaccine on 05Jan2021 in her right upper arm. Patient stated initially she had a sore arm, fatigue, chills, and body aches. Patient stated 5 days later she had redness and swelling in her lymph node on her right side. Patient stated 10 days later she had peripheral neuropathy and tingling in arms and feet. Patient stated she then developed a burning sensation in her legs. Patient stated that the MD did a full workup on her. Patient stated that all tests came back negative. Patient stated that the MD gave her gabapentin. Patient stated she could not sleep well due to tingling sensation and pain. Patient would like to know if this has been reported. Patient stated today she feels fine. Patient stated this was a scary episode for her and 1st dose of the Moderna COVID-19 vaccine was very debilitating. Patient stated that she has not received the 2nd dose and does not want to receive the 2nd dose of the Moderna COVID 19 vaccine.   Patient was treated with Gabapentin by an MD.  Action taken with mRNA-1273 in response to the event was not provided/unknown.   The outcome of the event was unknown/not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the reported event, a causal relationship cannot be excluded. Chills fatigue and lymphadenopathy are consistent with the known safety profile of the vaccine.