chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Swelling
Clinical narrative: swelling; redness; This case was reported by a consumer and described the occurrence of swelling in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced swelling and erythema. On an unknown date, the outcome of the swelling and erythema were unknown.   It was unknown if the reporter considered the swelling and erythema to be related to Shingrix.  Additional details were provided as follows: The age group was not reported but was captured as adult as per the vaccine indication. After receiving Shingrix, the patient had swelling and redness. The patient was asking what could he/she took to help reduce this reaction, Benadryl.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Skin warm
Clinical narrative: I go the vaccine A couple days later I had redness on my arm that went away 5 days later, a week later my arm  rash was more severe and hot to the touch, from shoulder down to my elbow, I contacted the Dr which thought it was a sterile abcess and prescribed ibuprofen and went away after another week
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Discomfort, Dizziness, Feeling cold, Herpes zoster
Clinical narrative: almost passed out; felt discomfort; He was very cold; chills; This case was reported by a consumer and described the occurrence of chills in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced chills, presyncope, discomfort and cold. On an unknown date, the outcome of the chills, presyncope, discomfort and cold were recovered/resolved.   It was unknown if the reporter considered the chills, presyncope, discomfort and cold to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received his 2nd dose a month ago from the date of reporting.   He was very cold and had chills on the day of administration that lasted for 24 hours.  He almost passed out the day after administration.  He reported that he felt discomfort for 2 weeks.   He was not able provide specific details regarding the discomfort feeling. Did not consent to follow-up.
Age: 91.0
Sex: M
Vaccine: VARZOS
Symptoms: Presyncope, Prophylaxis
Clinical narrative: almost passed out; felt discomfort; He was very cold; chills; This case was reported by a consumer and described the occurrence of chills in a 91-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced chills, presyncope, discomfort and cold. On an unknown date, the outcome of the chills, presyncope, discomfort and cold were recovered/resolved.   It was unknown if the reporter considered the chills, presyncope, discomfort and cold to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received his 2nd dose a month ago from the date of reporting.   He was very cold and had chills on the day of administration that lasted for 24 hours.  He almost passed out the day after administration.  He reported that he felt discomfort for 2 weeks.   He was not able provide specific details regarding the discomfort feeling. Did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased, Myalgia, Neuropathy peripheral, Pain in extremity
Clinical narrative: neuropathy in foot and calf.; muscle pain; joint pain in the hip, knee and ankle.; is having trouble sitting because of the pain; This case was reported by a consumer via call center representative and described the occurrence of peripheral neuropathy in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd January 2021, the patient received the 1st dose of Shingrix. On 3rd January 2021, 1 days after receiving Shingrix, the patient experienced peripheral neuropathy (serious criteria GSK medically significant), muscle pain, joint pain and mobility decreased. On an unknown date, the outcome of the peripheral neuropathy, muscle pain and joint pain were not recovered/not resolved and the outcome of the mobility decreased was unknown.   It was unknown if the reporter considered the peripheral neuropathy, muscle pain, joint pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving Shingrix, the patient had some complications.  The next day after receiving Shingrix, the patient had muscle pain and joint pain in the hip, knee and ankle.  She was having trouble sitting because of the pain and neuropathy in foot and calf. The reporter did not consent to follow-up.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer.  An adult (18-64 Years) male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date at SINGLE DOSE for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient experienced slightly sore arm muscle on an unspecified date. The outcome of event was recovered. Patient did not received any treatment for the event. No follow-up attempts are possible. Information on lot/batch cannot be obtained. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia, Pyrexia
Clinical narrative: Fever 100.6F, joint ache, myalgia, fatigue, chills.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ecchymosis, Immune thrombocytopenia, Petechiae, Platelet count decreased
Clinical narrative: Immune Thrombocytopenia Purpura; the only feature that was new to her was the vaccination provided 23Dec2020 and 09Jan2021 to complete her COVID series; This is a spontaneous report from a contactable physician. A 31-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunization. Medical history included eczema, no known allergies. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular on 23Dec2020 at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was seen in the ED for petechiae and ecchymoses on 15Jan2021. She had not taken any recent medication or had any illness previous to this event. The only feature that was new to her was the vaccination provided 23Dec2020 and 09Jan2021 to complete her COVID series. Lab assessment showed platelet count decreased to 22,000 cells per cubic microliter (normal over 140,000). She had no other findings to describe cause of her decreased platelet count by lab or clinical exam. Provided a diagnosis of immune thrombocytopenia purpura, in the ED setting, she started pulse dexamethasone 40 mg/day for four consecutive days with a follow blood count showing resolution on day 4 of her treatment with a platelet count of 230,000 cells per cubic microliter. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received Steroids as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of event immune thrombocytopenia purpura was recovered in Jan2021.  Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of immune thrombocytopenia purpura due to temporal relationship. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including platelet count at baseline and during therapy with subject drug, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Differential white blood cell count, Full blood count, Petechiae
Clinical narrative: Immune Thrombocytopenia Purpura; the only feature that was new to her was the vaccination provided 23Dec2020 and 09Jan2021 to complete her COVID series; This is a spontaneous report from a contactable physician. A 31-year-old female patient (not pregnant) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunization. Medical history included eczema, no known allergies. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via Intramuscular on 23Dec2020 at single dose for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was seen in the ED for petechiae and ecchymoses on 15Jan2021. She had not taken any recent medication or had any illness previous to this event. The only feature that was new to her was the vaccination provided 23Dec2020 and 09Jan2021 to complete her COVID series. Lab assessment showed platelet count decreased to 22,000 cells per cubic microliter (normal over 140,000). She had no other findings to describe cause of her decreased platelet count by lab or clinical exam. Provided a diagnosis of immune thrombocytopenia purpura, in the ED setting, she started pulse dexamethasone 40 mg/day for four consecutive days with a follow blood count showing resolution on day 4 of her treatment with a platelet count of 230,000 cells per cubic microliter. The events resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The patient received Steroids as treatment. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient was not been tested for COVID-19. The outcome of event immune thrombocytopenia purpura was recovered in Jan2021.  Information on lot/batch number has been requested.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of immune thrombocytopenia purpura due to temporal relationship. There is limited information provided in this report.  Additional information is needed to better assess the case, including complete medical history, diagnostics including platelet count at baseline and during therapy with subject drug, counteractive treatment measures and concomitant medications.  This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: LEFT SHOULDER JOINT PAIN ONSET WITHIN ONE DAY AFTER INJECTION. PRESENTATION CONSISTENT WITH Shoulder Injury Related to Vaccine Administration,.  Pain. decreased tolerance for exertion/lifting, persisting for over 40 days.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Muscular weakness, Paraesthesia, Rash
Clinical narrative: Patient received COVID vaccine Pfizer first dose in vaccine clinic.  Her symptoms started 5 min after injection, lasted 10-15 min and resolved.  She started feeling tingly in her arms, then noticed a red, raised, blotchy rash on her arms.  She felt hot and a little weak in the legs.  No oral swelling, throat tightening, shortness of breath, nausea, vomiting, diarrhea.  Symptoms onset 5 min after vaccine, symptoms resolved spontaneously within 15 min.  Patient transferred to ED.  No symptoms in ED.  Patient given Benadryl in ED.  Observed, no further symptoms.  Dc home with Epi pen
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular, Rash papular
Clinical narrative: Patient received COVID vaccine Pfizer first dose in vaccine clinic.  Her symptoms started 5 min after injection, lasted 10-15 min and resolved.  She started feeling tingly in her arms, then noticed a red, raised, blotchy rash on her arms.  She felt hot and a little weak in the legs.  No oral swelling, throat tightening, shortness of breath, nausea, vomiting, diarrhea.  Symptoms onset 5 min after vaccine, symptoms resolved spontaneously within 15 min.  Patient transferred to ED.  No symptoms in ED.  Patient given Benadryl in ED.  Observed, no further symptoms.  Dc home with Epi pen
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose increased, Cyanosis, Eye movement disorder, Metabolic function test, Myoclonus
Clinical narrative: Seizure - onset approximately 1 hour after vaccination administration. No medical history of seizures. Duration estimated 3 min - myoclonic head jerking, eyes rolled back, cyanosis
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Seizure
Clinical narrative: Seizure - onset approximately 1 hour after vaccination administration. No medical history of seizures. Duration estimated 3 min - myoclonic head jerking, eyes rolled back, cyanosis
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Headache, Pain
Clinical narrative: Burning and stinging in head as soon as I woke up the day after getting the vaccine. Feels like my brain is being pricked by needles. It?s been 4 hours and hasn?t stopped yet.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes to back of head, and neck x 5
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Erythema, Peripheral swelling, Skin warm, Staphylococcal infection
Clinical narrative: Patient called us on 1/30/21,  and said she may have had a reaction to Moderna COVID-19 shot on 1/18/21.  She said after ~3 days (1/21/21), her right arm become hot, red, swollen down to above her elbow.  She went to Urgent Caremon 1/30/21, and they told her it appeared to be cellulitis (staph infection) and would treat it accordingly.  She got an antibiotic shot and a steroid shot and was to pick up some other meds at her other pharmacy.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lip swelling
Clinical narrative: Patient developed swelling of previously injected dermal filler in her upper lip. Swelling developed  the morning of 1/29. It was almost completely resolved by 1/30. Patient was treated with  oral antihistamines (Benadryl and Xyzal).  She had Vobella injected into her upper lip in Februrary 2020 and Restylane Kysse injected into both upper and lower lip in September 2020. Since swelling was only noted on the upper lip, I suspect reaction to the Vobella product.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: The injection site got red and swollen, very itchy lasting 48 hrs.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Given quadracel and proquad as part of 5 year well visit. (1st time for proquad, had MMR and Varicella) Within a few minutes, patient developed an urticarial rash on his left arm and spreading to his chest. No trouble breathing or wheezing. No facial or tongue swelling. Was given Benadryl and monitored in the office for 30 minutes.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain, Pain in extremity, Tenderness
Clinical narrative: "left arm increased redness and pain and 4 inches in circumferernce, with soreness and pain with movement or touch"
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Nausea, Vaccine positive rechallenge, Visual impairment, Vomiting
Clinical narrative: 1225- Patient reported nausea, visual spots, and fatigue after receiving second dose of vaccine to the Nurse. She also reported that she had the same symptoms after receiving the first Pfizer vaccine.  Vitals were taking and patient was monitored. Patient later starting vomiting in clinic. EMS was called and patient left via ambulance. Methodist ED contacted prior to the patient arriving.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Nausea, Tremor, Visual impairment, Vomiting
Clinical narrative: 1225- Patient reported nausea, visual spots, and fatigue after receiving second dose of vaccine to the Nurse. She also reported that she had the same symptoms after receiving the first Pfizer vaccine.  Vitals were taking and patient was monitored. Patient later starting vomiting in clinic. EMS was called and patient left via ambulance. Methodist ED contacted prior to the patient arriving.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: 8 days after injection I woke with a very itchy, red and swollen arm where the injection had been given
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Arthralgia, Chills, Fatigue, Headache
Clinical narrative: I felt a little fatigued all day after the shot, but nothing more. As soon as 10pm (02/01/2021) came around I had a pounding headache. The most intense headache of my life. I also got an intense stomachache and it felt like I had an ulcer. That progressed to a low grade fever, chills, myalgia, and arthralgia. The myalgia and arthralgia were so intense that moving to stretch my legs was incredibly painful. I was also very nauseous. The intensity of the arthralgia and myalgia subsided around 8am on 02/01/2021. All my other symptoms continued until around 11am on 2/2/2021. I still have a headache and some muscle pain, but they are manageable.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: I felt a little fatigued all day after the shot, but nothing more. As soon as 10pm (02/01/2021) came around I had a pounding headache. The most intense headache of my life. I also got an intense stomachache and it felt like I had an ulcer. That progressed to a low grade fever, chills, myalgia, and arthralgia. The myalgia and arthralgia were so intense that moving to stretch my legs was incredibly painful. I was also very nauseous. The intensity of the arthralgia and myalgia subsided around 8am on 02/01/2021. All my other symptoms continued until around 11am on 2/2/2021. I still have a headache and some muscle pain, but they are manageable.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Left arm, near injection site started to itch. About eight days after vaccination. The area got very red and swollen.  The area was approximately 3 inches by 5 inches.  It was not specifically painful, more uncomfortable and annoying it continued to be very itchy!  The redness,swelling and itchin began to subside after about 4 days and basically completely gone after a week from its first inception.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Localized itching, erythema, swelling at site of injection and below (upper arm only), approx 12 days after vaccine.  No other known source
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Sleep disorder
Clinical narrative: Headache and fatigue.  Difficulty sleeping   Took naproxen?s for headache.  Gone but still fatigued
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Excruciating headache one hour after receiving vaccine. Headache is the worse I have ever had in my life. The pain was focused on both sides of my head. After 15 hours, I took Naproxen. It did not help. I stayed in bed because I didn't want to move my head. Headache resolved after 22 hours.  I had no other symptoms!
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Chest X-ray abnormal, Condition aggravated, Fibrosis, Hypoxia
Clinical narrative: Vaccination date: 1/30/21. Nausea, vomiting & abdominal pain started 1/31/21, day after vaccination.   Presented to emergency room 2/1/21. found to be hypoxic 85% (pt. had not been on supplemental 02). chest x-ray showed some patchy opacities likely COVID-19 induced fibrosis (per MD progress notes)
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Lung opacity, Nausea, Vomiting
Clinical narrative: Vaccination date: 1/30/21. Nausea, vomiting & abdominal pain started 1/31/21, day after vaccination.   Presented to emergency room 2/1/21. found to be hypoxic 85% (pt. had not been on supplemental 02). chest x-ray showed some patchy opacities likely COVID-19 induced fibrosis (per MD progress notes)
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dysuria, Headache, Myalgia
Clinical narrative: Fever to 105.6 (infrared device), severe myalgias and arthralgias, chills, Headaches, dysuria and testicular pain.  Improvement with Ibuprofen and acetaminophen.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Testicular pain
Clinical narrative: Fever to 105.6 (infrared device), severe myalgias and arthralgias, chills, Headaches, dysuria and testicular pain.  Improvement with Ibuprofen and acetaminophen.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, SARS-CoV-2 test positive, Vomiting
Clinical narrative: Resident developed uncontrolled coughing and vomiting. sent to ER resident tested positive for COVID-19 however resident originally tested positive  on 12/04/20
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Cough, Diarrhoea, Feeling abnormal, Hypersomnia
Clinical narrative: On Saturday the 30th well I started off I didn't feel good. I noticed that I had a temperature of around 99.6 and I normally don't get a fever. As it got later I aching, a bad cough and diarrhea. During the night I temperature of around 101. The next morning I called my son and he came over and he called an urgent care who advised him that is was probably a reaction to the vaccine and to give me Tylenol. I got better and my temperature went down yesterday (Monday). I still didn't feel good on Monday and slept all day.  I still feel a little washed out today.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: On Saturday the 30th well I started off I didn't feel good. I noticed that I had a temperature of around 99.6 and I normally don't get a fever. As it got later I aching, a bad cough and diarrhea. During the night I temperature of around 101. The next morning I called my son and he came over and he called an urgent care who advised him that is was probably a reaction to the vaccine and to give me Tylenol. I got better and my temperature went down yesterday (Monday). I still didn't feel good on Monday and slept all day.  I still feel a little washed out today.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: RECIEVED VACCINE ON THURSDAY, ON SUNDAY PATIENT REPORTS THAT SHE STARTED HAVING SHOOTING PAIN FROM LEFT THIGHT DOWN TO FEET, ON SCALE OF 1-10 PATIENT RATES PAIN AT 8.  SHE REPORTS THAT PAIN IS ABOUT THE SAME TODAY
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Joint swelling, Nausea, Pain
Clinical narrative: 3 days after taking 2nd dose of covid vaccine developed chills, headache, nausea, vomiting, bodyache, joint swelling, rash and itching all over body.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Vomiting
Clinical narrative: 3 days after taking 2nd dose of covid vaccine developed chills, headache, nausea, vomiting, bodyache, joint swelling, rash and itching all over body.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: on 2/1/21 had extreme body aches, headache, fatigue, around 1:30 pm body chills and fever developed, i went to sleep and at 8 pm woke up with fever 101.2,
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Throat closing in feeling ~24 hours after vaccine, lasting ~48 hours. Antihistamine needed.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Chills, Fatigue, Oropharyngeal pain
Clinical narrative: After first dose; chills, aches, sore throat, congestion, fatigue, loss of smell and taste
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Respiratory tract congestion, SARS-CoV-2 test positive
Clinical narrative: After first dose; chills, aches, sore throat, congestion, fatigue, loss of smell and taste
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Erythema, Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Nine days after the injection was received an area 2 inches wide and 3 inches long around the injection site became raised, red, hard and very itchy. Patient used Benadryl to treat it. 2 days later the raised effect and hardness had gone away, however the redness spread over most of the shoulder area, and 2 days after that had spread halfway down her upper arm. The itch remained. Patient went to a previously scheduled appointment with our primary care physician who said that she had had a DAR (delayed anaphylactic reaction) and should not get the second dose of the vaccine.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling
Clinical narrative: Nine days after the injection was received an area 2 inches wide and 3 inches long around the injection site became raised, red, hard and very itchy. Patient used Benadryl to treat it. 2 days later the raised effect and hardness had gone away, however the redness spread over most of the shoulder area, and 2 days after that had spread halfway down her upper arm. The itch remained. Patient went to a previously scheduled appointment with our primary care physician who said that she had had a DAR (delayed anaphylactic reaction) and should not get the second dose of the vaccine.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: under age administration.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site rash, Injection site warmth, Rash papular
Clinical narrative: Red, raised rash on left arm near injection site. Warm and sensitive to touch.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Woke up this morning with a large red circle around the injection site approximately the size of a tea cup saucer with warmth and slight amount of swelling noted.  Nurse advising to contact PCP for further treatment.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation
Clinical narrative: patient developed A-fib after receiving Moderna Vaccine
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus, Rash macular
Clinical narrative: Pt states that her left deltoid, site of injection, began to swell "the size of a softball", was red and itchy, one week after vaccine administration on 1/25/2021; Pt states that she also began noticing "red-raised, blotchy spots" on her bilateral upper legs, torso and chest, bilateral arms,  lower back that were itchy; both lasted about one week and started to resolve; Pt states she spoke with her PCP, and took Claritin, which she stated helped with the itching.  Pt called to report this side effect today, 2/2/21, and states all side effects resolved, excepted for "some faded blotches" on her body.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular
Clinical narrative: Pt states that her left deltoid, site of injection, began to swell "the size of a softball", was red and itchy, one week after vaccine administration on 1/25/2021; Pt states that she also began noticing "red-raised, blotchy spots" on her bilateral upper legs, torso and chest, bilateral arms,  lower back that were itchy; both lasted about one week and started to resolve; Pt states she spoke with her PCP, and took Claritin, which she stated helped with the itching.  Pt called to report this side effect today, 2/2/21, and states all side effects resolved, excepted for "some faded blotches" on her body.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia oral, Lip swelling
Clinical narrative: After 15 min had no reaction 25 min later my upper lip swelled slightly and had numbness feeling around my mouth
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Sudden swelling and redness around injection site. Initial swelling/redness had subsided significantly, then I woke up to a very painful swelling/redness. The swelling/redness was approximately 4 inches wide & 4 inches tall - expanding from the injection site. This lasted from Jan. 20th-Jan. 24th then subsided suddenly. As of Jan. 25th, the swelling/redness is gone. I did not seek treatment for this.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Injection site bruising
Clinical narrative: Burning  sensation in abdomen  & upper track lasted for approx 3 hours.   Bruise (black & blue) on the  injection site (right arm).
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: My arm was severely sore for two days
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Injection site rash, Pain in extremity, Pruritus, Rash
Clinical narrative: Per husband: "Wife developed severe chicken pox all over body. Wife got shock- for two days, she had sore shoulder, on the 3rd/4th day she starting developing rash on site where she got the shot. Then rash spread to her other side and now rash has spread all over the body. Thought it would go away in a day or two, but hasn't. She has had the rash for 8 days."   Further investigation on interview: It started approximately 3-4 hours after vaccination. First a sore arm then it felt itchy. She then noticed red raised spots. This rash has resolved slowly but "almost back to normal" as of Feb. 1. She still wants to get her second dose on Feb. 2 as scheduled.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Rash papular, Shock, Varicella
Clinical narrative: Per husband: "Wife developed severe chicken pox all over body. Wife got shock- for two days, she had sore shoulder, on the 3rd/4th day she starting developing rash on site where she got the shot. Then rash spread to her other side and now rash has spread all over the body. Thought it would go away in a day or two, but hasn't. She has had the rash for 8 days."   Further investigation on interview: It started approximately 3-4 hours after vaccination. First a sore arm then it felt itchy. She then noticed red raised spots. This rash has resolved slowly but "almost back to normal" as of Feb. 1. She still wants to get her second dose on Feb. 2 as scheduled.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Bruxism, Hypoaesthesia, Hypoaesthesia eye, Hypoaesthesia oral, Stress
Clinical narrative: About one hour after injection developed left facial numbness while I was on my way home. Not full numbness, but felling as if coming out of a novocaine shot. Left side chin, lips, cheek extending up to ear/eye. No sign of swelling, droop, redness. Has lasted 2 weeks + and has improved over time but not fully resolved. Now is more an occasional numb feeling mostly in L cheek/lips/corner of L eye. I grind my teeth during stressful times and grind more on my left side so was thinking it could be related to that. Sought medical attention from my doctor who felt said most likely not Bell's palsy related.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pruritus, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Itchy/red rash across my chest, neck, and arms and headache.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Flank pain, Herpes zoster, Rash
Clinical narrative: During the evening of the day that the vaccine was given, patient had pain in right flank.  Pain lessened the next day.  That second night at about 3:00 AM, she was awakened by severe pain in the same area.  The next day, she went to her physician.  By that time, she had a rash in the right flank area.  Her physician diagnosed shingles and  prescribed Valtrex.   The Valtrex , along with ice, subdued her pain. and after 2 weeks, her symptoms resolved.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Magnetic resonance imaging, Mobility decreased
Clinical narrative: Severe and prolonged injection site pain in left deltoid, affecting range of motion.   Still persists as of 2/2/2021.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Bone pain, Chills, Diarrhoea, Headache
Clinical narrative: Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On 1/25/21 I also had fever (highest was 101.4), chills, weakness, and aching bones.  I also had a terrible headache that started 1/20 and lasted until 1/ 28 or 1/29.  There was the normal injection site soreness on the evening of the first day.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Late (11 pm ish) on 1/24/21 severe diarrhea started, lasted through early (8 am ish) on 1/26/21. On 1/25/21 I also had fever (highest was 101.4), chills, weakness, and aching bones.  I also had a terrible headache that started 1/20 and lasted until 1/ 28 or 1/29.  There was the normal injection site soreness on the evening of the first day.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Pruritus, Rash
Clinical narrative: I received the 2nd vaccine a week ago (01/26/2021), and I had a rash on my arm which cause swelling, pain in the area and itchy it last for 3 days.
Age: 94.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Mobility decreased, Ultrasound scan
Clinical narrative: Long lasting pain in injection site starting several hours after shot and progressively has gotten worse over the last 4 months causing limited mobility of left arm.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Injection site reaction, Pruritus, Skin warm, Urticaria
Clinical narrative: below injection site is a 3 inch wide welt, wrapped around inner arm itchy red hot
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Basophil count normal, Basophil percentage decreased, Blood potassium decreased, Decreased appetite, Diarrhoea
Clinical narrative: Hypereosinophilia with fever and enteritis. Anorexia presented within 24-48 hours of injection, first episode of diarrhea 48-72 hours, becoming severe and requiring rehydration and potassium replacement at walk-in clinic on 1/26/21. Labs drawn at visit showed hypereosinophilia (14%, 1700). Patient started 3 day course of 30 mg prednisone daily; Lab redraw on 1/29 showed eosinophils at 16%, 2600, fever (intermittent to 102 F) and diarrhea continuing. No other household members sick. After telemedicine appoitment with Allergist, patient started on methylprednisolone dose pack, diarrhea and fever resolving.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Enteritis, Eosinophil count increased, Eosinophil percentage increased, Eosinophilia, Haematocrit increased
Clinical narrative: Hypereosinophilia with fever and enteritis. Anorexia presented within 24-48 hours of injection, first episode of diarrhea 48-72 hours, becoming severe and requiring rehydration and potassium replacement at walk-in clinic on 1/26/21. Labs drawn at visit showed hypereosinophilia (14%, 1700). Patient started 3 day course of 30 mg prednisone daily; Lab redraw on 1/29 showed eosinophils at 16%, 2600, fever (intermittent to 102 F) and diarrhea continuing. No other household members sick. After telemedicine appoitment with Allergist, patient started on methylprednisolone dose pack, diarrhea and fever resolving.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Haemoglobin normal, Lymphocyte count increased, Lymphocyte percentage decreased, Monocyte count increased, Monocyte percentage increased
Clinical narrative: Hypereosinophilia with fever and enteritis. Anorexia presented within 24-48 hours of injection, first episode of diarrhea 48-72 hours, becoming severe and requiring rehydration and potassium replacement at walk-in clinic on 1/26/21. Labs drawn at visit showed hypereosinophilia (14%, 1700). Patient started 3 day course of 30 mg prednisone daily; Lab redraw on 1/29 showed eosinophils at 16%, 2600, fever (intermittent to 102 F) and diarrhea continuing. No other household members sick. After telemedicine appoitment with Allergist, patient started on methylprednisolone dose pack, diarrhea and fever resolving.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Neutrophil count normal, Neutrophil percentage decreased, Pyrexia, Red blood cell count increased, White blood cell count increased
Clinical narrative: Hypereosinophilia with fever and enteritis. Anorexia presented within 24-48 hours of injection, first episode of diarrhea 48-72 hours, becoming severe and requiring rehydration and potassium replacement at walk-in clinic on 1/26/21. Labs drawn at visit showed hypereosinophilia (14%, 1700). Patient started 3 day course of 30 mg prednisone daily; Lab redraw on 1/29 showed eosinophils at 16%, 2600, fever (intermittent to 102 F) and diarrhea continuing. No other household members sick. After telemedicine appoitment with Allergist, patient started on methylprednisolone dose pack, diarrhea and fever resolving.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Angioedema, Erythema, Eye pruritus, Pruritus
Clinical narrative: Angioedema type of reaction: Itching of both eyes. Itching , redness, and slight swelling  of cheeks, elbows, knees, knuckles of both hands about 48 hours post vaccine.  I have had this type of reaction previously - unknown trigger, not related to a vaccine. I took one benadryl dose, and called my PCP office. The nurse took the info, and advised me to take another benadryl if needed, and to call her back in 1 hr.  I called her back reporting that the reaction had subsided. She game the same advise and told to make sure to call back if needed.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have tiny little bumps all over my face, chest, hands and arms. I am not sure that is is related by the vaccine is the only thing different I have done/had over the last 10 days.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: SYMPTOMS BEGAN 1/29/21, FEVER 102, CHILLS, JOINT PAINS, RED RASH TO LEFT DELTOID AREA TO LEFT ELBOW WITH HARD SWELLING TO INJECTION SITE PER PATIENT.  PT CALLED HER PRIMARY PROVIDER. NOT SEEN IN PER BY PROVIDER. PT HAVE BEEN TAKING TYLENOL  /    SPOKE WITH PT ON 2/2/21 , SHE INDICATED THAT SHE IS DOING MUCH BETTER. RASH, SWELLING AND  FEVER RESOLVED.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: SYMPTOMS BEGAN 1/29/21, FEVER 102, CHILLS, JOINT PAINS, RED RASH TO LEFT DELTOID AREA TO LEFT ELBOW WITH HARD SWELLING TO INJECTION SITE PER PATIENT.  PT CALLED HER PRIMARY PROVIDER. NOT SEEN IN PER BY PROVIDER. PT HAVE BEEN TAKING TYLENOL  /    SPOKE WITH PT ON 2/2/21 , SHE INDICATED THAT SHE IS DOING MUCH BETTER. RASH, SWELLING AND  FEVER RESOLVED.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest pain, Chills, Feeling abnormal, Hypoaesthesia oral
Clinical narrative: Patient had  a covid vaccine at 9:25am.  Please note the patient has no history of anaphylaxis, panic attacks, or heart issues.  She started saying her lips were feeling numb and kind of strange and her back hurting. 50mg of benadryl was given at 940am.  Patient continued to decline. She complained of chills, chest pain, and n/v. She was visibly shaking. BP was 168/137 HR 99 and oxygen 96%. 911 was called at 9:45am. AMR arrived at 9:55am and took over. Patient was taken to ER.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tremor, Vomiting
Clinical narrative: Patient had  a covid vaccine at 9:25am.  Please note the patient has no history of anaphylaxis, panic attacks, or heart issues.  She started saying her lips were feeling numb and kind of strange and her back hurting. 50mg of benadryl was given at 940am.  Patient continued to decline. She complained of chills, chest pain, and n/v. She was visibly shaking. BP was 168/137 HR 99 and oxygen 96%. 911 was called at 9:45am. AMR arrived at 9:55am and took over. Patient was taken to ER.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Laboratory test, Palpitations, Paraesthesia
Clinical narrative: Palpitations with numbness and tingling of extremities.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Facial asymmetry, Facial paralysis, Rash, Swelling face
Clinical narrative: Facial swelling and temporary paralysis to left side of face started 1/10/21. Swelling lasted two days. Facial paralysis 24 hrs, and facial symmetry still not corrected as of 2/2/2021. Entire facial rash started 1/21/2021. Rash started on face and moved down neck and chest. I took Benadryl for three days, which didn?t help. I then started a steroid regimen. 40 mg for three days. 20 mg for three days. I took last dose on Friday, 1/29/21. Rash was resistant to steroid until day three of regimen. Mild shortness of breath occurred 1/23/21, and lasted no more than an hour.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Heart rate irregular
Clinical narrative: Heartbeat irregularities & "thumps" and intense headache -- both starting 6-8 hrs after injection and lasting  36 hours. Also chills but no fever.  Fatigue. I stayed in bed the entire next day.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Mobility decreased
Clinical narrative: "Left arm. I do not have full range of motion."
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: Within 15-minutes of vaccination, the patient reported a "scratchy" sensation in their throat. They were monitored on-site by EMS. No documentation provided suggesting allergic reaction that needed treatment.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Abdominal pain upper, Chills, Cholecystitis, Computerised tomogram abdomen abnormal
Clinical narrative: On 21st -22nd morning started having severe vomiting x 8-10 episodes with nausea, chills, and headache. On Sunday 1/24/21-1/26 started with severe epigastric sharp upper abdominal pain, never had before. Was getting worse. Went to virtua ER on 1/26/21 evening, had ct scan with contrast showing fluid around galbladder and ultrasound showed wall thickening to 11mm, positive Murphy?s sign and fluid around galbladder. I was admitted overnight and surgeon had recommended removal due to ejection fraction of 12% from hida scan done on  1/27. Endoscopy was done also and was negative. Cholecysitis was the presumed diagnosis, with normal LFTS. I left and returned to ER where they did repeat ct scan showing distention , pain continued. Admitted for 1 night.  Pain was improving on Friday 1/29 , when I was discharged after repeated ultrasound showed resolved fluid. No history of any previous GI issues and no gallstones were noted on any imaging. I consume a healthy diet. Now having continued epigastric pain but improving.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram abnormal, Endoscopy normal, Gallbladder enlargement, Headache, Hepatobiliary scan
Clinical narrative: On 21st -22nd morning started having severe vomiting x 8-10 episodes with nausea, chills, and headache. On Sunday 1/24/21-1/26 started with severe epigastric sharp upper abdominal pain, never had before. Was getting worse. Went to virtua ER on 1/26/21 evening, had ct scan with contrast showing fluid around galbladder and ultrasound showed wall thickening to 11mm, positive Murphy?s sign and fluid around galbladder. I was admitted overnight and surgeon had recommended removal due to ejection fraction of 12% from hida scan done on  1/27. Endoscopy was done also and was negative. Cholecysitis was the presumed diagnosis, with normal LFTS. I left and returned to ER where they did repeat ct scan showing distention , pain continued. Admitted for 1 night.  Pain was improving on Friday 1/29 , when I was discharged after repeated ultrasound showed resolved fluid. No history of any previous GI issues and no gallstones were noted on any imaging. I consume a healthy diet. Now having continued epigastric pain but improving.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hepatobiliary scan abnormal, Laboratory test, Liver function test normal, Nausea, Pain
Clinical narrative: On 21st -22nd morning started having severe vomiting x 8-10 episodes with nausea, chills, and headache. On Sunday 1/24/21-1/26 started with severe epigastric sharp upper abdominal pain, never had before. Was getting worse. Went to virtua ER on 1/26/21 evening, had ct scan with contrast showing fluid around galbladder and ultrasound showed wall thickening to 11mm, positive Murphy?s sign and fluid around galbladder. I was admitted overnight and surgeon had recommended removal due to ejection fraction of 12% from hida scan done on  1/27. Endoscopy was done also and was negative. Cholecysitis was the presumed diagnosis, with normal LFTS. I left and returned to ER where they did repeat ct scan showing distention , pain continued. Admitted for 1 night.  Pain was improving on Friday 1/29 , when I was discharged after repeated ultrasound showed resolved fluid. No history of any previous GI issues and no gallstones were noted on any imaging. I consume a healthy diet. Now having continued epigastric pain but improving.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Ultrasound abdomen abnormal, Vomiting
Clinical narrative: On 21st -22nd morning started having severe vomiting x 8-10 episodes with nausea, chills, and headache. On Sunday 1/24/21-1/26 started with severe epigastric sharp upper abdominal pain, never had before. Was getting worse. Went to virtua ER on 1/26/21 evening, had ct scan with contrast showing fluid around galbladder and ultrasound showed wall thickening to 11mm, positive Murphy?s sign and fluid around galbladder. I was admitted overnight and surgeon had recommended removal due to ejection fraction of 12% from hida scan done on  1/27. Endoscopy was done also and was negative. Cholecysitis was the presumed diagnosis, with normal LFTS. I left and returned to ER where they did repeat ct scan showing distention , pain continued. Admitted for 1 night.  Pain was improving on Friday 1/29 , when I was discharged after repeated ultrasound showed resolved fluid. No history of any previous GI issues and no gallstones were noted on any imaging. I consume a healthy diet. Now having continued epigastric pain but improving.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Immediate post-injection reaction, Metabolic function test, Muscular weakness, Pallor, Urine organic acid test
Clinical narrative: patient appeared pale immediately after shot, then 24 hours later mom felt he was pale and a bit limp
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: swelling in arm redness in arm  sore
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Erythema, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: swelling in arm redness in arm  sore
Age: 78.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: swelling in arm redness in arm  sore