chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Eye haemorrhage, Injection site pruritus, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: 3 eye blood capyllaries had exploded; itchy in the site of injection; swelling and warm; Felt local pain in the other arm; swelling and warm; A spontaneous report was received from a consumer who was also a patient who received Moderna's Covid-19 vaccine (mRNA-1273) and experienced 3 eye blood capillaries had exploded, pain the in other arm, and itchy, swelling and warm in the site of injection.  The patient's medical history included hyperthyroidism. Products known to have been used by the patient, within two weeks prior to the event, included thiamazole, glucomannan and celecoxib.  The patient received their first of two planned doses of mRNA-1273 (Lot number: 026L20A) on 04 Jan 2021 in the left arm intramuscuarly in for prophylaxis of COVID-19 infection.   A consumer who is the patient called to report she received the Moderna COVID-19 vaccine on 04 Jan 2021. She reported the injection site itched, had swelling and was warm. The patient also reported she felt local pain on the opposite arm that was vaccinated.   On 05 Jan 2021, the patient stated her doctor told her that she had 2 or 3 eye blood capillaries that had exploded. The patient reported it was better, did not have any pain, and it was not itchy.    Treatment for the event included paracetamol.  Action taken with mRNA-1273 in response to the events was not provided.   The outcome of the events, pain the in other arm, and itchy, swelling and warm in the site of injection, was unknown. The outcome of the event, 3 eye blood capillaries had exploded, was recovering.; Reporter's Comments: This case concerns a 33-year-old, female, patient, who experienced a serious unexpected event of eye hemorrhage and non-serious unexpected events of injection site warmth, pain in extremity and non-serious expected event of injection site swelling and injection site pruritus. The event of injection site pruritus, injection site warmth, pain in extremity, and injection site swelling occurred 1 day (same day) after first dose of mRNA-1273, lot # 026L20A. The event of eye hemorrhage occurred 2 days after first dose of mRNA-1273, lot # 026L20A. Treatment included Panadol. The subject's concomitant medications included Tapazole, Propol, Celexa. Based on the current available information and temporal association between the use of the product and onset of the events a causal relationship cannot be excluded.
Age: 43.0
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactoid reaction
Clinical narrative: Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning a, 43-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms.  The patient's medical history included breast cancer. The patient had no history of allergies or prior vaccine reactions. No concomitant medications were reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a 43-year-old patient with medical history of breast cancer, who received their first of two planned doses of mRNA-1273 (Lot 041L20A), and who experienced the serious unlisted event of anaphylaxis-like symptoms.  Based on the current available information and temporal association between the use of the product and the onset of event on the day of vaccination, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Flushing, Pruritus
Clinical narrative: Vaccine was administered at 9:20 AM by public health at the Community Center; patient was observed for 30 minutes without problems; patient reports she left after 30 minutes of observation and was on her way home when she started to feel itchy and scratched under her chin; around 10:15 AM she had more itching and redness to her skin and was flushed in her cheeks so she took a dose of over the counter Benadryl. by mouth; she continued to have itching throughout the day and reports she took another dose of Benadryl at 4:00 p.m. and again at around 2:00 a.m..
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactoid reaction
Clinical narrative: Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning, 60-year-old, patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms.  The patient's medical history included rheumatoid arthritis, hypertension and allergies to diphenhydramine and meperidine.  No concomitant medications were reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a  60-year-old patient who received their first of two planned doses of mRNA-1273 (Lot 041L20A), and who experienced the serious unlisted event of anaphylaxis-like symptoms.  Very limited information regarding this event has been provided at this time. Based on the current available information and temporal association between the use of the product and the onset of event on the day of vaccination, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Age: 23.0
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactoid reaction
Clinical narrative: Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning a, 23-year-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms.   The patient's medical history included allergy to soy.  No concomitant medications were reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a 23-year-old patient who experienced a serious, unexpected event of Anaphylactoid reaction. The event occurred same day (exact time not provided) after the first dose of mRNA-1273 (Lot number: 041L20A) administration. The treatment included EpiPen injection. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactoid reaction
Clinical narrative: Anaphylaxis-like symptoms; A spontaneous report was received from a physician concerning a 56-year-old patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced anaphylaxis-like symptoms.    The patient's medical history was not reported. No concomitant medications were reported.  On 13 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.  On 13 Jan 2021, the patient experienced anaphylaxis-like symptoms that included, anaphylaxis, angioedema, shortness of breath, itching, swelling of eyes, and sleepiness. The patient was treated with epinephrine injections and taken to the emergency department.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, anaphylaxis-like symptoms, was unknown.; Reporter's Comments: This case concerns a 56-year-old patient . The patient's medical history was not reported. The patient experienced a serious, unexpected event of Anaphylactoid reaction. The event occurred the day the patient  received the first dose of mRNA-1273 (Lot number: 041L20A) at an unspecified time. 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: Product administered to patient of inappropriate age
Clinical narrative: Hospital accidently gave the Moderna vaccine to 16 years old; A spontaneous report  was received from a healthcare professional concerning a 16-year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273).  The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received their first dose of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the 16 year old patient was accidentally given the Moderna vaccine rather than the Pfizer vaccine. She was told to restart the vaccine series with the Pfizer vaccine. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The event, hospital accidently gave the Moderna vaccine to 16 years old, was considered resolved on an unknown date.; Reporter's Comments: This case concerns a 16 year old female patient who was accidentally given the Moderna vaccine rather than the Pfizer vaccine. There were no reported adverse events associated with this event of product administered to patient of inappropriate age.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Breast tenderness, Chills, Injection site erythema
Clinical narrative: The first dose was given on 12/30/20 with site soreness and slight redness.  Redness was gone in about three days and the soreness was gone after two weeks. The second dose was given 1/27/21. About 12 hours after given the 2nd vaccine, I woke up from a sleep with chills, temp of 99.2, muscle and joint aches, breast tenderness, site soreness, slight redness.  These symptoms were expected and my temperature was normal after taking a shower and drinking some water.  The chills persisted and I checked my temp a few times to make sure I didn't have a temperature.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Myalgia
Clinical narrative: The first dose was given on 12/30/20 with site soreness and slight redness.  Redness was gone in about three days and the soreness was gone after two weeks. The second dose was given 1/27/21. About 12 hours after given the 2nd vaccine, I woke up from a sleep with chills, temp of 99.2, muscle and joint aches, breast tenderness, site soreness, slight redness.  These symptoms were expected and my temperature was normal after taking a shower and drinking some water.  The chills persisted and I checked my temp a few times to make sure I didn't have a temperature.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypersomnia, Nausea, Pain
Clinical narrative: Chills, Body Aches , Fever, Headache, Nausea,   Slept for 36 Hours, then felt fine.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills, Body Aches , Fever, Headache, Nausea,   Slept for 36 Hours, then felt fine.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dizziness, Impaired work ability, Mobility decreased, Muscular weakness
Clinical narrative: Night of vaccination: Extreme pain and stiffness in left arm. Unable to move fingers on left hand. Morning after vaccination: Unable to stand without feeling faint. Got sent home from work because I felt like I was going to pass out. Soreness in right chest, just below collarbone. Day three: sore spot is swollen and hurting worse.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity, Swelling
Clinical narrative: Night of vaccination: Extreme pain and stiffness in left arm. Unable to move fingers on left hand. Morning after vaccination: Unable to stand without feeling faint. Got sent home from work because I felt like I was going to pass out. Soreness in right chest, just below collarbone. Day three: sore spot is swollen and hurting worse.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Skin warm, Throat irritation
Clinical narrative: Pt returned to the pharmacy 10 or 15 following administration of her 2nd dose stating her throat was getting itchy.  (pt was waiting in hallway)  Pt was given oral a Diphenhydramine 50mg capsule at 9:25am.  Pulse was 118.  Pt was still red faced and reporting that she was hot at 9:30am.  Pt was given 10ml Diphenhydramine 12.5/5ml at 9:33.  Paramedics arrived at 9:45.  O2 sats were 100%.  Breath sounds were good.  Pt choose to go to hospital b/c she would be alone at home.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Anticonvulsant drug level therapeutic, Blood culture negative, Chest X-ray normal, Culture urine negative, Seizure
Clinical narrative: He had a generalized seizure just over 48 hours from the administration of the second dose in the series. He has a longstanding seizure history with periodic seizures. He was hospitalized for two days which infection was ruled out and he had returned to baseline. There was no attribution of the seizure to the vaccine by the hospital team.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: no side effects  2nd dose given too soon
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: headache, bone and muscle aches on left side (collar bone, shoulder blade, rib cage, neck, back), fever (99.5-100.5 for 1+ days), nausea (5+ days)
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Immunoglobulin therapy, Injection site rash, Noninfective gingivitis
Clinical narrative: Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days.  By Saturday, her symptoms began to improve.  On Monday 1/25/21, the patient developed a petechial rash around the injection site and noticed sores on her gums and the patient went to OR.  Evaluation at outside ED showed a platelet count of 2,000 with a normal H/H.  Patient was transferred to our hospital for increased level of care, hematology consult and platelet transfusions.  Significant hematology workup with a clinical picture thought to be consistent with ITP.  Patient started on dexamethasone 40mg and received IVIG x 3 doses and platelet counts have started to improve
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Petechiae, Platelet count decreased
Clinical narrative: Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days.  By Saturday, her symptoms began to improve.  On Monday 1/25/21, the patient developed a petechial rash around the injection site and noticed sores on her gums and the patient went to OR.  Evaluation at outside ED showed a platelet count of 2,000 with a normal H/H.  Patient was transferred to our hospital for increased level of care, hematology consult and platelet transfusions.  Significant hematology workup with a clinical picture thought to be consistent with ITP.  Patient started on dexamethasone 40mg and received IVIG x 3 doses and platelet counts have started to improve
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Apparent life threatening event, Dizziness, Erythema, Full blood count abnormal, Headache
Clinical narrative: Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days.  By Saturday, her symptoms began to improve.  On Monday 1/25/21, the patient developed a petechial rash around the injection site and noticed sores on her gums and the patient went to OR.  Evaluation at outside ED showed a platelet count of 2,000 with a normal H/H.  Patient was transferred to our hospital for increased level of care, hematology consult and platelet transfusions.  Significant hematology workup with a clinical picture thought to be consistent with ITP.  Patient started on dexamethasone 40mg and received IVIG x 3 doses and platelet counts have started to improve
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Oral mucosal eruption, Oral mucosal erythema, Platelet count decreased, Platelet transfusion, Rash
Clinical narrative: Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days.  By Saturday, her symptoms began to improve.  On Monday 1/25/21, the patient developed a petechial rash around the injection site and noticed sores on her gums and the patient went to OR.  Evaluation at outside ED showed a platelet count of 2,000 with a normal H/H.  Patient was transferred to our hospital for increased level of care, hematology consult and platelet transfusions.  Significant hematology workup with a clinical picture thought to be consistent with ITP.  Patient started on dexamethasone 40mg and received IVIG x 3 doses and platelet counts have started to improve
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Thrombocytopenia, Tongue eruption, Tongue erythema
Clinical narrative: Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days.  By Saturday, her symptoms began to improve.  On Monday 1/25/21, the patient developed a petechial rash around the injection site and noticed sores on her gums and the patient went to OR.  Evaluation at outside ED showed a platelet count of 2,000 with a normal H/H.  Patient was transferred to our hospital for increased level of care, hematology consult and platelet transfusions.  Significant hematology workup with a clinical picture thought to be consistent with ITP.  Patient started on dexamethasone 40mg and received IVIG x 3 doses and platelet counts have started to improve
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fatigue, Headache, Immune thrombocytopenia, Immunoglobulin therapy, Injection site rash
Clinical narrative: Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days.  By Saturday, her symptoms began to improve.  On Monday 1/25/21, the patient developed a petechial rash around the injection site and noticed sores on her gums and the patient went to OR.  Evaluation at outside ED showed a platelet count of 2,000 with a normal H/H.  Patient was transferred to our hospital for increased level of care, hematology consult and platelet transfusions.  Significant hematology workup with a clinical picture thought to be consistent with ITP.  Patient started on dexamethasone 40mg and received IVIG x 3 doses and platelet counts have started to improve
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Injection site reaction, Oral mucosal eruption, Petechiae, Platelet count decreased, Platelet transfusion
Clinical narrative: Patient received vaccine Thursday 1/21/21 and experienced headache and fatigue for two days.  By Saturday, her symptoms began to improve.  On Monday 1/25/21, the patient developed a petechial rash around the injection site and noticed sores on her gums and the patient went to OR.  Evaluation at outside ED showed a platelet count of 2,000 with a normal H/H.  Patient was transferred to our hospital for increased level of care, hematology consult and platelet transfusions.  Significant hematology workup with a clinical picture thought to be consistent with ITP.  Patient started on dexamethasone 40mg and received IVIG x 3 doses and platelet counts have started to improve
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Headache, Nasal congestion, Pain
Clinical narrative: This is a spontaneous report from a contactable other health professional.  A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EV0140, via an unspecified route of administration in the left arm on 03Jan2021 13:00 at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. Patient was not pregnant at vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Concomitant medication included Simvastatin, Gabapentin, Flonase, Claritin and multi (not specified). The patient previously took codeine and experienced allergy. Within two days (on 05Jan2021), patient experienced headaches, body aches, fatigue, nasal congestion. Strength not yet fully recovered ten days out. The outcome of events was recovering. Patient did not receive any treatment for the events. No follow-up attempts are possible. No further information is expected. Information on the lot/batch number has been obtained.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arthralgia, Chills, Ear discomfort, Headache, Pain in extremity
Clinical narrative: knees kegs ache head ache about 20 pist injection . then around 4 pm joint pain worsen. at 2am got chills headache. an arm started hurting down my arm an up into my clavical. still head ache an my joints hurt very bad. at 1220 pm friday in bed  hurtying  feels very much like  my shingling vaccination.  my ears are starding to burn.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose fluctuation, Chills, Discomfort, Dizziness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: Apr2021), via an unspecified route of administration on 12Jan2021 08:00 at a single dose on left arm for COVID-19 immunization. Medical history included diabetes, stent, and cholesterol. Concomitant medication included metformin for diabetes, atorvastatin from 2009 (also reported as Jan2020) for cholesterol, ticagrelor (BRILINTA, NDC: 01860776-60, LOT: MM0189, EXP: Apr2023), saxagliptin hydrochloride (ONGLYZA, NDC: 0310-6105-90, LOT: MJ0731, EXP: Feb2023) for diabetes, and terbinafine. The patient experienced felt bad the first day, chills, wooziness/ woozy, felt wobbly all on 12Jan2021. Then experienced feeling like has a big weight on him, blood sugar has been lower than normal, it is usually normal at 110-120, it is lower today at 96/ checked his blood sugar again later and it was 153, which is not through the roof on 14Jan2021, and he is real tired on Jan2021. Patient says he got the Pfizer vaccine, clarified to Pfizer BioNTech COVID-19 vaccine, a couple days ago and the first day he felt bad and had chills and felt wobbly and woozy. He says yesterday (13Jan2021) he felt pretty good, and even worked out. He says he also worked out today, but he has had chills and feels like he has a big weight walking on him, he doesn't know the right word. He says he is also a diabetic, and he noticed today that his blood sugar has been lower than normal, it is usually normal at 110-120, it is lower today at 96. He says he is careful with his diet and eats the same thing. He says he hasn't taken his meds today, and he checked his blood sugar again later and it was 153, which is not through the roof, even without his medication so he would like to know does the vaccine affect your blood sugar? He says he got his first dose of the vaccination on Tuesday at 08:00AM, in his left arm. He clarifies that he has had chills today and then feels like there is a big heavy weight on him, he is real tired and his sugar is low, that was odd. The outcome of the events was unknown.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Gait disturbance
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 60-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: Apr2021), via an unspecified route of administration on 12Jan2021 08:00 at a single dose on left arm for COVID-19 immunization. Medical history included diabetes, stent, and cholesterol. Concomitant medication included metformin for diabetes, atorvastatin from 2009 (also reported as Jan2020) for cholesterol, ticagrelor (BRILINTA, NDC: 01860776-60, LOT: MM0189, EXP: Apr2023), saxagliptin hydrochloride (ONGLYZA, NDC: 0310-6105-90, LOT: MJ0731, EXP: Feb2023) for diabetes, and terbinafine. The patient experienced felt bad the first day, chills, wooziness/ woozy, felt wobbly all on 12Jan2021. Then experienced feeling like has a big weight on him, blood sugar has been lower than normal, it is usually normal at 110-120, it is lower today at 96/ checked his blood sugar again later and it was 153, which is not through the roof on 14Jan2021, and he is real tired on Jan2021. Patient says he got the Pfizer vaccine, clarified to Pfizer BioNTech COVID-19 vaccine, a couple days ago and the first day he felt bad and had chills and felt wobbly and woozy. He says yesterday (13Jan2021) he felt pretty good, and even worked out. He says he also worked out today, but he has had chills and feels like he has a big weight walking on him, he doesn't know the right word. He says he is also a diabetic, and he noticed today that his blood sugar has been lower than normal, it is usually normal at 110-120, it is lower today at 96. He says he is careful with his diet and eats the same thing. He says he hasn't taken his meds today, and he checked his blood sugar again later and it was 153, which is not through the roof, even without his medication so he would like to know does the vaccine affect your blood sugar? He says he got his first dose of the vaccination on Tuesday at 08:00AM, in his left arm. He clarifies that he has had chills today and then feels like there is a big heavy weight on him, he is real tired and his sugar is low, that was odd. The outcome of the events was unknown.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Facial pain, Fatigue, Inappropriate schedule of product administration, Influenza
Clinical narrative: This is a spontaneous report from a contactable nurse (patient herself). A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date not reported), via an unspecified route of administration in the left deltoid on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing ulcerative colitis from 2009 and exposure to a positive COVID patient on 08Jan2021. The patient also had a sinus drainage down the back of her throat. It went away but started back up on 09Jan2021. It is the same since last night but had improved from over the weekend. Concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EH9899, expiry date not reported) on 21Dec2020 at single dose for COVID-19 immunisation. The patient had her second COVID19 Vaccine dose last Saturday and reported having a "weird reaction". She had already gone to urgent care and was told to call. She experienced rash from Monday evening in the knees and elbows which spread to face and joint areas (knees, ankles, toe, hip, wrist), which occurred as splotches of red; some were raised bumps with symptoms relieved with Benadryl. Patient said that she was not sure if she was having a reaction or not to the Pfizer COVID Vaccine. She was just in urgent care that morning and was going to primary care that afternoon. Urgent care thought she was having a reaction. She got her second dose of the vaccine on Saturday morning, 09Jan2021. That night she had the typical immune response.  She had chills, sore muscles, sore throat, fatigue, and facial pain from sinus pressure, which lasted through Sunday. She took Sudafed PE and Monday when she woke up, she felt normal. She experienced rash from Monday evening in the knees and elbows which spread to face and joint areas (knees, ankles, toe, hip, wrist, fingers, feet, face, upper arms), rash which occurred as splotches of red; some were raised bumps with symptoms relieved with Benadryl. Benadryl helped it get better, but after it wears off the rash comes back and it gets worse. It had spread to different areas. Sometimes, it will be really bad on her knees, then other times really bad on her elbows or hips. Her hips were bad last night. Now it is on the bottom of her feet and on her knees again. She asked if these were something that have been previously reported. All of these symptoms, besides the rash, she felt like she had the flu. It knocked her on her ass it was pretty terrible. But it went away and she felt better. It was a typical immune response so she would say it was not serious. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Jan2021. Clinical outcome of events chills, sore muscles, sore throat, fatigue, and facial pain from sinus pressure was recovered on 11Jan2021, while for the other events was not recovered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Paranasal sinus discomfort, Rash, Rash macular
Clinical narrative: This is a spontaneous report from a contactable nurse (patient herself). A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date not reported), via an unspecified route of administration in the left deltoid on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing ulcerative colitis from 2009 and exposure to a positive COVID patient on 08Jan2021. The patient also had a sinus drainage down the back of her throat. It went away but started back up on 09Jan2021. It is the same since last night but had improved from over the weekend. Concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EH9899, expiry date not reported) on 21Dec2020 at single dose for COVID-19 immunisation. The patient had her second COVID19 Vaccine dose last Saturday and reported having a "weird reaction". She had already gone to urgent care and was told to call. She experienced rash from Monday evening in the knees and elbows which spread to face and joint areas (knees, ankles, toe, hip, wrist), which occurred as splotches of red; some were raised bumps with symptoms relieved with Benadryl. Patient said that she was not sure if she was having a reaction or not to the Pfizer COVID Vaccine. She was just in urgent care that morning and was going to primary care that afternoon. Urgent care thought she was having a reaction. She got her second dose of the vaccine on Saturday morning, 09Jan2021. That night she had the typical immune response.  She had chills, sore muscles, sore throat, fatigue, and facial pain from sinus pressure, which lasted through Sunday. She took Sudafed PE and Monday when she woke up, she felt normal. She experienced rash from Monday evening in the knees and elbows which spread to face and joint areas (knees, ankles, toe, hip, wrist, fingers, feet, face, upper arms), rash which occurred as splotches of red; some were raised bumps with symptoms relieved with Benadryl. Benadryl helped it get better, but after it wears off the rash comes back and it gets worse. It had spread to different areas. Sometimes, it will be really bad on her knees, then other times really bad on her elbows or hips. Her hips were bad last night. Now it is on the bottom of her feet and on her knees again. She asked if these were something that have been previously reported. All of these symptoms, besides the rash, she felt like she had the flu. It knocked her on her ass it was pretty terrible. But it went away and she felt better. It was a typical immune response so she would say it was not serious. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Jan2021. Clinical outcome of events chills, sore muscles, sore throat, fatigue, and facial pain from sinus pressure was recovered on 11Jan2021, while for the other events was not recovered.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable nurse (patient herself). A 28-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176, expiry date not reported), via an unspecified route of administration in the left deltoid on 09Jan2021 at single dose for COVID-19 immunisation. Medical history included ongoing ulcerative colitis from 2009 and exposure to a positive COVID patient on 08Jan2021. The patient also had a sinus drainage down the back of her throat. It went away but started back up on 09Jan2021. It is the same since last night but had improved from over the weekend. Concomitant medications were not reported. The patient previously took first dose of bnt162b2 (lot number: EH9899, expiry date not reported) on 21Dec2020 at single dose for COVID-19 immunisation. The patient had her second COVID19 Vaccine dose last Saturday and reported having a "weird reaction". She had already gone to urgent care and was told to call. She experienced rash from Monday evening in the knees and elbows which spread to face and joint areas (knees, ankles, toe, hip, wrist), which occurred as splotches of red; some were raised bumps with symptoms relieved with Benadryl. Patient said that she was not sure if she was having a reaction or not to the Pfizer COVID Vaccine. She was just in urgent care that morning and was going to primary care that afternoon. Urgent care thought she was having a reaction. She got her second dose of the vaccine on Saturday morning, 09Jan2021. That night she had the typical immune response.  She had chills, sore muscles, sore throat, fatigue, and facial pain from sinus pressure, which lasted through Sunday. She took Sudafed PE and Monday when she woke up, she felt normal. She experienced rash from Monday evening in the knees and elbows which spread to face and joint areas (knees, ankles, toe, hip, wrist, fingers, feet, face, upper arms), rash which occurred as splotches of red; some were raised bumps with symptoms relieved with Benadryl. Benadryl helped it get better, but after it wears off the rash comes back and it gets worse. It had spread to different areas. Sometimes, it will be really bad on her knees, then other times really bad on her elbows or hips. Her hips were bad last night. Now it is on the bottom of her feet and on her knees again. She asked if these were something that have been previously reported. All of these symptoms, besides the rash, she felt like she had the flu. It knocked her on her ass it was pretty terrible. But it went away and she felt better. It was a typical immune response so she would say it was not serious. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Jan2021. Clinical outcome of events chills, sore muscles, sore throat, fatigue, and facial pain from sinus pressure was recovered on 11Jan2021, while for the other events was not recovered.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dry skin, Paraesthesia, Skin warm
Clinical narrative: 1115 resident w hx congenital weakness to R arm reporting R arm tingling sensation after Moderna COVID 19 injection at 1100. On assessment, injection site without bleeding or edema, R arm warm, dry, pink, cap refill <2 sec in R hand. R hand grip 4/5. Continue to monitor. 1130: sensation resolving, physical exam unchanged. 1140: sensation completely resolved. Resident to report any new or worsening. Report in VAERS.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm was only slightly sore; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that the patient's arm was only slightly sore on an unspecified date. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: Low grade fever; Chills; Rash; This is a spontaneous report from a contactable healthcare professional. A 75-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), intramuscular on 10Jan2021 at single dose for COVID-19 immunization. Medical history included urinary tract infection (UTI). Patient stated she was on an antibiotic for a UTI before having the vaccine. No other vaccine in four weeks. No COVID prior vaccination.  The patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. Patient stated that she broke out with a rash across chest and legs approximately 24 hours (on 11Jan2021) after having the vaccine. Patient states she had a low grade fever and chills 4 days post covid-19 vaccination (on 14Jan2021).  The events resulted in doctor or other healthcare professional office/clinic visit  The patient received treatment for the events. The patient was given a steroid shot by dermatologist. Patient was tested for COVID test post vaccination (covid test type: Nasal Swab) which showed negative result. The outcome of the events was not recovered.  Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid-19 (asymptomatic); tested positive for Covid-19 (asymptomatic); This is a spontaneous report from a contactable pharmacist. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were unknown), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient tested positive for Covid-19 (asymptomatic) on 13Jan2021. The pharmacist wanted to know if a person who was administered with the first dose of the Covid-19 vaccine on  administered on 04Jan2021 and on 13Jan2021 tested positive for Covid-19 (asymptomatic) and needs to quarantine can proceed with the second dose of the vaccine or if it's contraindicated. The pharmacist also wanted to know if it was okay to give the second dose as long as 90 days if a person with Covid-19 is deferred after recovering, and also asked when the second dose can be received if somebody did not recover fully from Covid. The outcome of the event was unknown.   Information on the batch/lot number has been requested.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be excluded for reported "tested positive for Covid-19".
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Nodule, Rash
Clinical narrative: knot in arm, slight rash
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chest discomfort, Chills, Dyspnoea
Clinical narrative: heaviness in chest with right flank pain; lots of phlegm; Pulse oximeter 89%; difficulty breathing heaviness in chest/Shortness of breath; difficulty breathing heaviness in chest/ heaviness in chest with right flank pain; Chills; Sensitive skin; Super Thirsty; Fever 100.7/Low grade fever 99.9/ Low grade fever 99.0; Joint Pain; Congestion; Right arm injection site severe pain; This is a spontaneous report from a contactable other healthcare professional (Patient). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration on 06Jan2021 10:30 at single dose in Right arm for COVID-19 immunization.  Medical history included hypertension. Concomitant medication included benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL/HCTZ, 10-12.5 MG Tablet), ascorbic acid, biotin, boron, calcium, calcium pantothenate, chlorine, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine hydrochloride, tocopherol, vanadium, zinc (CENTRUM SILVER).  The patient previously took codeine and experienced allergy. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. The patient did not have covid-19 tested post vaccination. On 06Jan2021 20:00, the patient experienced Fever 100.7, Joint Pain, Congestion, Right arm injection site severe pain. On 07Jan2021, the patient experienced Chills, Fever 100.7, Sensitive skin, Super Thirsty. On 08Jan2021, the patient had Temperature 98.8, No Chills, Thirsty. On 09Jan2021, the patient was Some relief, no fever, no chills, no joint pain. On 10Jan2021, the patient experienced low grade fever 99.9, Pulse oximeter 89%, difficulty breathing heaviness in chest. On 11Jan2021, oxygen was 92%, Low grade fever 99.0. On 12Jan2021, vital signs stable no fever 97.7, oxygen 96%. On 13Jan2021, Vital Signs stable. On 14Jan2021, the patient experienced Shortness of breath, heaviness in chest with right flank pain, lots of phlegm, Temperature 98.0, Oximeter 96%. Coricidin HBP taken to relieve Congestion. Therapeutic measures were taken as a result of all reported events. The outcome of event chills was recovered on 08Jan2021, outcome of event Fever (event onset date: 06Jan2021 20:00) was recovered on 09Jan2021, outcome of event Low grade fever (event onset date: 10Jan2021) was recovered on 12Jan2021, outcome of event Joint Pain was recovered in Jan2021. The outcome of the other events was recovering.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Flank pain, Nasal congestion, Oxygen saturation, Oxygen saturation decreased, Productive cough
Clinical narrative: heaviness in chest with right flank pain; lots of phlegm; Pulse oximeter 89%; difficulty breathing heaviness in chest/Shortness of breath; difficulty breathing heaviness in chest/ heaviness in chest with right flank pain; Chills; Sensitive skin; Super Thirsty; Fever 100.7/Low grade fever 99.9/ Low grade fever 99.0; Joint Pain; Congestion; Right arm injection site severe pain; This is a spontaneous report from a contactable other healthcare professional (Patient). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration on 06Jan2021 10:30 at single dose in Right arm for COVID-19 immunization.  Medical history included hypertension. Concomitant medication included benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL/HCTZ, 10-12.5 MG Tablet), ascorbic acid, biotin, boron, calcium, calcium pantothenate, chlorine, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine hydrochloride, tocopherol, vanadium, zinc (CENTRUM SILVER).  The patient previously took codeine and experienced allergy. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. The patient did not have covid-19 tested post vaccination. On 06Jan2021 20:00, the patient experienced Fever 100.7, Joint Pain, Congestion, Right arm injection site severe pain. On 07Jan2021, the patient experienced Chills, Fever 100.7, Sensitive skin, Super Thirsty. On 08Jan2021, the patient had Temperature 98.8, No Chills, Thirsty. On 09Jan2021, the patient was Some relief, no fever, no chills, no joint pain. On 10Jan2021, the patient experienced low grade fever 99.9, Pulse oximeter 89%, difficulty breathing heaviness in chest. On 11Jan2021, oxygen was 92%, Low grade fever 99.0. On 12Jan2021, vital signs stable no fever 97.7, oxygen 96%. On 13Jan2021, Vital Signs stable. On 14Jan2021, the patient experienced Shortness of breath, heaviness in chest with right flank pain, lots of phlegm, Temperature 98.0, Oximeter 96%. Coricidin HBP taken to relieve Congestion. Therapeutic measures were taken as a result of all reported events. The outcome of event chills was recovered on 08Jan2021, outcome of event Fever (event onset date: 06Jan2021 20:00) was recovered on 09Jan2021, outcome of event Low grade fever (event onset date: 10Jan2021) was recovered on 12Jan2021, outcome of event Joint Pain was recovered in Jan2021. The outcome of the other events was recovering.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Sensitive skin, Thirst, Vaccination site pain
Clinical narrative: heaviness in chest with right flank pain; lots of phlegm; Pulse oximeter 89%; difficulty breathing heaviness in chest/Shortness of breath; difficulty breathing heaviness in chest/ heaviness in chest with right flank pain; Chills; Sensitive skin; Super Thirsty; Fever 100.7/Low grade fever 99.9/ Low grade fever 99.0; Joint Pain; Congestion; Right arm injection site severe pain; This is a spontaneous report from a contactable other healthcare professional (Patient). A 63-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL1284), via an unspecified route of administration on 06Jan2021 10:30 at single dose in Right arm for COVID-19 immunization.  Medical history included hypertension. Concomitant medication included benazepril hydrochloride, hydrochlorothiazide (BENAZEPRIL/HCTZ, 10-12.5 MG Tablet), ascorbic acid, biotin, boron, calcium, calcium pantothenate, chlorine, chromium, colecalciferol, copper, cyanocobalamin, folic acid, iodine, magnesium, manganese, molybdenum, nickel, nicotinamide, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, silicon dioxide, thiamine hydrochloride, tocopherol, vanadium, zinc (CENTRUM SILVER).  The patient previously took codeine and experienced allergy. There were no other vaccines received in four weeks. The patient did not have covid-19 prior vaccination. The patient did not have covid-19 tested post vaccination. On 06Jan2021 20:00, the patient experienced Fever 100.7, Joint Pain, Congestion, Right arm injection site severe pain. On 07Jan2021, the patient experienced Chills, Fever 100.7, Sensitive skin, Super Thirsty. On 08Jan2021, the patient had Temperature 98.8, No Chills, Thirsty. On 09Jan2021, the patient was Some relief, no fever, no chills, no joint pain. On 10Jan2021, the patient experienced low grade fever 99.9, Pulse oximeter 89%, difficulty breathing heaviness in chest. On 11Jan2021, oxygen was 92%, Low grade fever 99.0. On 12Jan2021, vital signs stable no fever 97.7, oxygen 96%. On 13Jan2021, Vital Signs stable. On 14Jan2021, the patient experienced Shortness of breath, heaviness in chest with right flank pain, lots of phlegm, Temperature 98.0, Oximeter 96%. Coricidin HBP taken to relieve Congestion. Therapeutic measures were taken as a result of all reported events. The outcome of event chills was recovered on 08Jan2021, outcome of event Fever (event onset date: 06Jan2021 20:00) was recovered on 09Jan2021, outcome of event Low grade fever (event onset date: 10Jan2021) was recovered on 12Jan2021, outcome of event Joint Pain was recovered in Jan2021. The outcome of the other events was recovering.