chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Neck pain, Pulse abnormal
Clinical narrative: Over the next week, BP low 90/62; Pulse 58 intermittently; lightheadedness; difficulty breathing; red flush to skin on the face; left neck & shoulder pain; left neck & shoulder pain/ hip pain; fatigue; Very disoriented; BP 182/98, elevated for me; Felt extremely unwell; This is a spontaneous report from a contactable other HCP reported for self. This 71-year-old female patient (No pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 28Jan2021 14:00 on Arm left at single dose (Lot # EK4176) for covid-19 immunisation. Medical history included Codeine experienced upset stomach only, Osteoporosis, nothing else ongoing. No covid prior vaccination. No other medications in two weeks. No other vaccine in four weeks. Within 6 minutes of injection had lightheadedness & difficulty breathing. This was followed by red flush to skin on the face. Within the next hour, left neck & shoulder pain, hip pain and fatigue. Very disoriented and BP 182/98, elevated for the patient, felt extremely unwell all on 28Jan2021. Over the next week, BP low 90/62 Pulse 58 intermittently in Feb2021. Doctor or other healthcare professional office/clinic visit, Prolongation of existing hospitalization. No covid tested post vaccination. No treatments received. Outcome of the events was not recovered.; Sender's Comments: Considering the plausible drug-event temporal association, a contributory role of the suspect product bnt162b2 (COMIRNATY) to the reported events cannot be excluded. 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.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Disease recurrence, Feeding disorder, Macule, Malaise
Clinical narrative: pneumonia; something wrong with his kidneys; dry heaves; he won't eat; had dots all over his back like it had exploded; rash; got sick; rash/ got sick; This is a spontaneous report from a contactable consumer. This consumer (wife) reported for a male patient (husband) that a male patient of an unspecified age received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 and got sick and rash. The reporter's husband had second shot and she knew he broke out in a red rash all over. He had the first one and got sick eight days later. He had been in the hospital. He saw his primary doctor when he got out of the hospital. He had dry heaves and he won't eat. He didn't want to drink any liquid. She was trying to make him drink. He didn't have a fever. His temp was 97.2. He might have had the rash with both doses. When he came home from the hospital he had a rash, but yesterday he was broken out all over. He got sick and had a test and didn't have it. It was on the twenty eighth when she put him in the hospital and he had pneumonia and something wrong with his kidneys. He was on an antibiotic. He got a rash anytime of the year. When he came home he had dots all over his back like it had exploded. She wanted to know if he could be allergic to this. The patient was hospitalized for the events pneumonia and something wrong with his kidneys. Treatment was received for the events pneumonia and something wrong with his kidneys. The outcome of the events was unknown.  Information about Lot/Batch number is requested.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia, Rash, Renal disorder, Retching
Clinical narrative: pneumonia; something wrong with his kidneys; dry heaves; he won't eat; had dots all over his back like it had exploded; rash; got sick; rash/ got sick; This is a spontaneous report from a contactable consumer. This consumer (wife) reported for a male patient (husband) that a male patient of an unspecified age received second dose of bnt162b2 (BNT162B2), via an unspecified route of administration, on an unspecified date at single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient previously received first dose of BNT162B2 and got sick and rash. The reporter's husband had second shot and she knew he broke out in a red rash all over. He had the first one and got sick eight days later. He had been in the hospital. He saw his primary doctor when he got out of the hospital. He had dry heaves and he won't eat. He didn't want to drink any liquid. She was trying to make him drink. He didn't have a fever. His temp was 97.2. He might have had the rash with both doses. When he came home from the hospital he had a rash, but yesterday he was broken out all over. He got sick and had a test and didn't have it. It was on the twenty eighth when she put him in the hospital and he had pneumonia and something wrong with his kidneys. He was on an antibiotic. He got a rash anytime of the year. When he came home he had dots all over his back like it had exploded. She wanted to know if he could be allergic to this. The patient was hospitalized for the events pneumonia and something wrong with his kidneys. Treatment was received for the events pneumonia and something wrong with his kidneys. The outcome of the events was unknown.  Information about Lot/Batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Cataract
Clinical narrative: cataract surgery; This is a spontaneous report from a contactable consumer via a Pfizer Sponsored program. A female patient of an unspecified age started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from an unspecified date to an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient scheduled next week for the 2nd dose of the vaccine on Friday. Will have a cataract surgery that needs Pre-Covid Test 2 days after the 2nd dose. Outcome was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea haemorrhagic
Clinical narrative: Diarrhea with bloody discharge; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer. A male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Feb2021 at SINGLE DOSE for Covid vaccine. The patient medical history and concomitant medications were not reported. The patient experienced diarrhea with bloody discharge. The outcome was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Narcolepsy, Pain
Clinical narrative: also suffers from Narcolepsy; fatigue; moderate body aches; This is a spontaneous report from a contactable consumer reported for self. This 23-year-old female consumer (patient) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose for covid-19 immunisation. She experienced fatigue and moderate body aches. She also suffers from Narcolepsy and takes Xywav nightly. Outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Deafness
Clinical narrative: Sudden never hearing loss; This is a spontaneous report from a contactable other healthcare professional (patient). A 33-year-old female patient received the first dose of bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: EJ1685), via an unspecified route of administration at the left arm on 20Jan2021 10:00 at single dose for COVID-19 immunization. The vaccine was administered in the hospital. The patient medical history was not reported. The patient was not pregnant. There was no other vaccine in four weeks. Prior to vaccination the patient had no COVID. The patient has not tested for COVID post vaccination. Concomitant medication included fluoxetine hydrochloride (PROZAC) and hctz. On 21Jan2021, the patient experienced sudden never hearing loss. It was reported that the event resulted to doctor or other healthcare professional office/clinic visit and Disability or permanent damage. The patient received an oral steroid as treatment. The outcome of the event was not recovered.; Sender's Comments: Based on the compatible temporal association and in absence of strong confounding factors, a possible contributory role of the suspect BNT162B2 in triggering the onset of sudden never hearing loss cannot be excluded. Additional information regarding relevant medical history, etiologic and diagnostic work-up will aid in comprehensive assessment of the case. 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.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Loss of consciousness, Malaise, Paraesthesia
Clinical narrative: Lost consciousness; possibly had a seizure; tingling in his hands; unable to speak; felt dizzy; was tired afterwards; felt sick; This is a spontaneous report from a contactable physician.  A 27-year-old male patient started to received dose 2 bnt162b2 (UNSPECIFIED TRADE NAME), via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient received BNT162B2 first dose on unspecified date with unspecified lot and expiration date.   The patient reported at 4:30 after second dose of vaccine lost consciousness for 15 seconds on an unspecified date, possibly had a seizure on an unspecified date, tingling in his hands on an unspecified date at 9:00 in the evening, unable to speak on an unspecified date for 15 seconds, felt dizzy on an unspecified date, was tired afterwards for about 2 hours on an unspecified date, and felt sick on an unspecified date.  Outcome of event Lost consciousness was recovered, possibly had a seizure was unknown, tingling in his hands recovered, unable to speak was recovered, felt dizzy was unknown, was tired afterwards recovered, and felt sick was unknown.  Information on the 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 seizure, LOC and other reported events 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 Head CT/MRI, serum toxicology screen, chemistry panel and EEG, 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.
Sex: M
Vaccine: COVID19
Symptoms: Seizure, Speech disorder
Clinical narrative: Lost consciousness; possibly had a seizure; tingling in his hands; unable to speak; felt dizzy; was tired afterwards; felt sick; This is a spontaneous report from a contactable physician.  A 27-year-old male patient started to received dose 2 bnt162b2 (UNSPECIFIED TRADE NAME), via an unspecified route of administration from an unspecified date to an unspecified date at SINGLE DOSE for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient received BNT162B2 first dose on unspecified date with unspecified lot and expiration date.   The patient reported at 4:30 after second dose of vaccine lost consciousness for 15 seconds on an unspecified date, possibly had a seizure on an unspecified date, tingling in his hands on an unspecified date at 9:00 in the evening, unable to speak on an unspecified date for 15 seconds, felt dizzy on an unspecified date, was tired afterwards for about 2 hours on an unspecified date, and felt sick on an unspecified date.  Outcome of event Lost consciousness was recovered, possibly had a seizure was unknown, tingling in his hands recovered, unable to speak was recovered, felt dizzy was unknown, was tired afterwards recovered, and felt sick was unknown.  Information on the 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 seizure, LOC and other reported events 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 Head CT/MRI, serum toxicology screen, chemistry panel and EEG, 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: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure
Clinical narrative: Tonic clonic seizure; This is a spontaneous report from a contactable physician. A 41-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date unknown), via an unspecified route of administration on 01Feb2021 14:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tonic clonic seizure on 01Feb2021, the same day. The patient received the dose at 14:00 and had the seizure around 19:00. Patient has recovered from the event on an unspecified date. No treatment was received for the event.   Information about lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported tonic clonic seizure and the administration of the COVID-19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.   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 RA, IEC, as appropriate.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: does have a compromised immune system and he is given Bivigam via IV on a monthly basis; This is a spontaneous report from a contactable consumer (patient). An 81-year-old male patient receive BNT162B2 (reported as COVID-19 vaccine, unspecified manufacture, lot/batch number and expiration date were unknown) via an unspecified route of administration on 03Feb2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. He got to a second and noticed something. He had a compromised immune system and he was given immunoglobulins human normal (Bivigam) via intravenous on a monthly basis. Patient wondering if this is okay with the vaccine. The outcome of event was unknown.  Pfizer is a marketing authorization holder of BNT162B2 in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of BNT162B2 has submitted the same report to the regulatory authorities.  Information on batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Haematochezia
Clinical narrative: Blood in stool; Stomach discomfort; This is a spontaneous report from a contactable consumer reporting for herself. A 65-year-old female patient received the 1st dose of bnt162b2 (BNT162B2, Manufacturer Pfizer BioNTech, Lot# FL9264), via an unspecified route of administration, on 04Feb2021 at 13:00, at single dose, for COVID-19 immunisation. Medical history was none. Concomitant medications were not reported. Patient did not have vaccinations within 4 weeks prior. The patient experienced blood in stool and stomach discomfort both on 05Feb2021 with outcome of recovering.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Arrhythmia, Heart rate, Tachycardia
Clinical narrative: Arrhythmia; Tachycardia, BP 103/min; This is a spontaneous report from a contactable other HCP.   A 25-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9264) on 05Feb2021 at single dose via an unspecified route of administration on left arm for COVID-19 immunization. The patient received first dose of BNT162B2 on 14Jan2021 at 03:45 pm on left arm. Concomitant medications were not reported. On 05Feb2021 at 15:00 the patient experienced Tachycardia with BP 103/min and Arrhythmia. No treatment was given for reported events. At the time of the reporting the patient had not yet recovered from the events.   The information on the lot/batch number has been requested.; Sender's Comments: Based on the temporal relationship, the association between the event arrhythmia with BNT162b2 can not be completely excluded.  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.
Sex: U
Vaccine: FLUX
Symptoms: Allergy to vaccine
Clinical narrative: Allergic to vaccine; Initial information was received on 08-Feb-2021 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional (patient).  This case involves a patient (unknown demographics) who was allergic to vaccine (allergy to vaccine), while he/she received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), concomitant medications and family history were not provided.  It was unknown if the patient had any medical history, concomitant disease or risk factor  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (produced by unknown manufacturer) (batch number and expiry date not reported) via an unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient was allergic to vaccine (allergy to vaccine) (unknown latency) following the administration of INFLUENZA VACCINE. The event was non-serious.  It was unknown if the patient experienced any additional symptoms/events.   The details of medication and reason for taking the medicine were not provided.  There were no lab data/results available.   At the time of reporting, the outcome was unknown for the event.  There will be no information available on batch number for this case.
Age: 1.42
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Expired product administered
Clinical narrative: the patient received an expired dose of vaccine, no AE; Initial information regarding an unsolicited valid non-serious case was received from a other health care professional via Medical Information (Reference number- 00459652) and transmitted to Sanofi on 03-Feb-2021.  This case is linked to case 2021SA045576 (same reporter).  This case involves a 17 months old male patient who received 0.5 ml fourth dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ21AAA, expiry date: 21-Oct-2020) via intramuscular route in the left deltoid for prophylactic vaccination on 26-Jan-2021 (Expired product administered)  The patient's past vaccination(s) included PENTACEL on 30-Oct-2019 (first dose) for prophylactic vaccination.  Medical history, medical treatment(s) and family history were not provided.  Concomitant medications included HEPATITIS A VACCINE for prophylactic vaccination  It was a case of an actual medication error due to Expired vaccine used (latency same day).  The reporter stated that 2 patients have received expired doses of Pentacel and asked if they need to re-dose second patient who received expired Pentacel by mistake.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Rash with a bump underneath at the injection site that occurred 8 days after injection. Rash decreased after taking hydroxazine, bump was still present at time of this reporting.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Skin warm
Clinical narrative: Rash, itchiness, very hot to the touch
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Blood pressure normal, Eye movement disorder, Loss of consciousness, Myoclonus
Clinical narrative: 15 year old, received Flu vaccine in nurses room, walked to room and 7 minutes later had syncope,  70 seconds later while sitting had loss of conscious and activity myoclonic in arms, head rolling back and eyes, seizure type activity, lasted 10-20 seconds.  BP and POCT glucose were normal-
Age: 15.0
Sex: F
Vaccine: FLU4
Symptoms: Seizure, Syncope, Vertigo
Clinical narrative: 15 year old, received Flu vaccine in nurses room, walked to room and 7 minutes later had syncope,  70 seconds later while sitting had loss of conscious and activity myoclonic in arms, head rolling back and eyes, seizure type activity, lasted 10-20 seconds.  BP and POCT glucose were normal-
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Generalised tonic-clonic seizure, Loss of consciousness, Urinary incontinence, Vomiting
Clinical narrative: Grand mal seizure.  Lasting 4 minutes , unconscious for 10/12 minutes. Transported to hospital via ambulance.   Vomiting and loss of bladder.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Fatigue several hours after shot.  Muscle soreness the day after the shot lasting for about 2 days. The fatigue would come and go for up to 5 days after the shot. I felt fine for a while then suddenly felt completely exhausted and had to lay down. The fatigue was the worst symptom. I did not seek treatment but rested. After five days, all symptoms were gone, and I returned to feeling well and normal function.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Migraine, Nausea
Clinical narrative: Migraine type headache, lethargic, nausea . Duration just one 12 hour period.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Erythema, Limb mass, Pain, Pruritus
Clinical narrative: Raised red ring appeared approx 7 days after the injection.  It was itchy and very painful. The lump on my arm is still there and the are remains slight bruised looking.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Raised red ring appeared approx 7 days after the injection.  It was itchy and very painful. The lump on my arm is still there and the are remains slight bruised looking.
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Epistaxis, Full blood count, Platelet count decreased
Clinical narrative: I developed nose bleeds after taking COVID shot and saw on the news that I?m the vaccine could cause thrombocytopenia. I had my doctor order a CBC on 2/17 and platelets came back at 89.  I did have a past history of thrombocytopenia throughout my pregnancy from 07/2019-01/2020.  Thrombocytopenia went away after delivering my baby and I haven?t had an issue since. Last CBC was 10/16/20 and at that time platelets were 156. Last abnormal platelet level was on 1/9/20 and level was 132.  As of now Dr. is monitoring me and will have me repeat CBC in 2 weeks.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Contusion, Full blood count, Immune thrombocytopenia, Pain in extremity
Clinical narrative: Appears that ITP has come back.  I have significant bruising on my left triceps, right triceps, and left hand.  I have not sustained any significant trauma that would have caused this type of bruising.  In addition, my right foot is very sore around the metatarsals.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Feeling cold, Feeling hot, Induration, Malaise
Clinical narrative: had severe pain in arm... hard hot spot from shoulder to elbow. went to bed woke up just after midnight shaking/very cold/burning up   felt like I was going to be sick ended up have violent diarrhea and throwing up, all the while shaking uncontrollably. went on until almost 5am
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Tremor, Vomiting
Clinical narrative: had severe pain in arm... hard hot spot from shoulder to elbow. went to bed woke up just after midnight shaking/very cold/burning up   felt like I was going to be sick ended up have violent diarrhea and throwing up, all the while shaking uncontrollably. went on until almost 5am
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Insomnia
Clinical narrative: Chills, headache, sweating, fatigue, can?t sleep
Age: 42.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Alopecia
Clinical narrative: 3 weeks later I'm noticing hair loss on both legs that has no other likely cause.  V-safe check-in app does not allow me to add this 3 weeks after vaccine, but I wanted to share it.  I did not find this listed on side effects and want to know if this is a concern and if I should get checked out by physician.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever chills achy
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills, fever, headache, body ache.  Three Advil. Symptoms went away after  about 9 hours
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: My left arm is hot like on fire and with extreme itching. It?s very hard around the area of injection and is very red.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Angiogram, Computerised tomogram thorax, Phlebitis, Ultrasound scan
Clinical narrative: L external cephalic phlebitis
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial test negative, Epstein-Barr virus antibody positive, HIV test negative, Pain, Vaginal ulceration
Clinical narrative: Vaginal (lipschutz) Ulcers developed 48 hours after administration. went to the urgent care 36 hours later. Provider prescribed 3%  lidocaine gel and 0.05% steroid cream and told to follow up with OBGYN. Next day OBGYN swabbed the ulcers for BV, HIV,  and viral culture. All results were negative. 2 days later, pain was significantly worse, saw the OBGYN again. Diagnosis of Lipschutz ulcers given. Perscribed 5% lidocaine ointment, 8 day oral steriod, tylenol and motrin for pain and witch hazel pads. Examination of by provider showed covers of ulcers coming off.  Dr. learned of association of lipschutz ulcers and EBV. Got tested for EBV 8 days after developing symptoms. EBV nuclear IgG positive, but no active EBV. Complete healing of ulcers 3 weeks after receiving the vaccine.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Viral test negative
Clinical narrative: Vaginal (lipschutz) Ulcers developed 48 hours after administration. went to the urgent care 36 hours later. Provider prescribed 3%  lidocaine gel and 0.05% steroid cream and told to follow up with OBGYN. Next day OBGYN swabbed the ulcers for BV, HIV,  and viral culture. All results were negative. 2 days later, pain was significantly worse, saw the OBGYN again. Diagnosis of Lipschutz ulcers given. Perscribed 5% lidocaine ointment, 8 day oral steriod, tylenol and motrin for pain and witch hazel pads. Examination of by provider showed covers of ulcers coming off.  Dr. learned of association of lipschutz ulcers and EBV. Got tested for EBV 8 days after developing symptoms. EBV nuclear IgG positive, but no active EBV. Complete healing of ulcers 3 weeks after receiving the vaccine.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Redness, pain, swelling itching at injection site, lasting at least 2 days so far, treated with ice, benadryl and ibuprofen with minimal effect
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth, Rash erythematous
Clinical narrative: Rash at injection site that showed up seven days after the shot. Currently on day four and the rash has spread every day. Currently covering about one third of upper left arm. Rash has been red, swollen, and hot, with occasionally itchiness. Rash is about four inches tall and wraps around most of the upper arm.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Pallor
Clinical narrative: Complaint of chest pain with no other signs and symptoms.  Denied shortness of breathe.  Vitals assessed.  Patient became pale in color and continued to have chest pain.  Given Benadryl and sent to local clinic for evaluation.   Clinic reported additional services at local emergency room.  No additional health outcome diagnosed or treated.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Mass, Pain, Pruritus, Swelling
Clinical narrative: It became red, swollen w/a big lump, achy. Then it went away. On 2/17 it came back again only covered a bigger area & was very itchy.  I was concerned that I got a 2d reaction a week after the first reaction. As of 12:50 a.m.  2/19 it is still reacting.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose #1 given 1/15/2021  Dose #2 was given too early on 2/6/2021 (day 22)
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Allergy to vaccine, Anaphylactic reaction, Asthma, Chest discomfort, Dizziness
Clinical narrative: She is a nurse and received her vaccine outside at the Vaccine Site. She had an immediate reaction to her first dose of the Pfizer Covid vaccine with acute hives within 15 minutes on 12/26.  She had hives on her neck, arms chest, headache arm pain and mild dizziness.  Symptoms resolved with Benadryl   She received her second dose of the Covid vaccine 12/26 with immediate symptoms within 30 minutes of respiratory symptoms, shortness of breath, hives, dizziness, fainting with treatment of epinephrine on site at the Vaccine Site by ambulance to the ER.  She reports she was hypoxic with O2 sat 70 to 75%. Went to hospital and received 3 doses of epinephrine, IV Benadryl, IV fluids, Pepcid, and 7 days of prednisone. 1/26: c/o chest tightness had video visit with primarily MD, continued diphenhydramine and refer to allergy. She does have a history of vaccine reaction in the past to Gardasiln (contains polysorbate 80)  given at age 16 with delayed hives 24 hours later. Allergist assessment: Covid vaccine 19 mRNA anaphylaxis with 2nd dose and acute hives with 1st dose of Pfizer vaccine S/p repeated doses of epipen   With ongoing asthma, dizziness, light headed , nausea  and fast heart rate 1.5 weeks after anaphylaxis but normotensive With prior history of delayed hives with gardisil  --may be sensitive to polysorbate 80 in both vaccines. Added COVID vaccine to allergy list
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Headache, Heart rate increased, Hypoxia, Nausea
Clinical narrative: She is a nurse and received her vaccine outside at the Vaccine Site. She had an immediate reaction to her first dose of the Pfizer Covid vaccine with acute hives within 15 minutes on 12/26.  She had hives on her neck, arms chest, headache arm pain and mild dizziness.  Symptoms resolved with Benadryl   She received her second dose of the Covid vaccine 12/26 with immediate symptoms within 30 minutes of respiratory symptoms, shortness of breath, hives, dizziness, fainting with treatment of epinephrine on site at the Vaccine Site by ambulance to the ER.  She reports she was hypoxic with O2 sat 70 to 75%. Went to hospital and received 3 doses of epinephrine, IV Benadryl, IV fluids, Pepcid, and 7 days of prednisone. 1/26: c/o chest tightness had video visit with primarily MD, continued diphenhydramine and refer to allergy. She does have a history of vaccine reaction in the past to Gardasiln (contains polysorbate 80)  given at age 16 with delayed hives 24 hours later. Allergist assessment: Covid vaccine 19 mRNA anaphylaxis with 2nd dose and acute hives with 1st dose of Pfizer vaccine S/p repeated doses of epipen   With ongoing asthma, dizziness, light headed , nausea  and fast heart rate 1.5 weeks after anaphylaxis but normotensive With prior history of delayed hives with gardisil  --may be sensitive to polysorbate 80 in both vaccines. Added COVID vaccine to allergy list
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Syncope, Urticaria
Clinical narrative: She is a nurse and received her vaccine outside at the Vaccine Site. She had an immediate reaction to her first dose of the Pfizer Covid vaccine with acute hives within 15 minutes on 12/26.  She had hives on her neck, arms chest, headache arm pain and mild dizziness.  Symptoms resolved with Benadryl   She received her second dose of the Covid vaccine 12/26 with immediate symptoms within 30 minutes of respiratory symptoms, shortness of breath, hives, dizziness, fainting with treatment of epinephrine on site at the Vaccine Site by ambulance to the ER.  She reports she was hypoxic with O2 sat 70 to 75%. Went to hospital and received 3 doses of epinephrine, IV Benadryl, IV fluids, Pepcid, and 7 days of prednisone. 1/26: c/o chest tightness had video visit with primarily MD, continued diphenhydramine and refer to allergy. She does have a history of vaccine reaction in the past to Gardasiln (contains polysorbate 80)  given at age 16 with delayed hives 24 hours later. Allergist assessment: Covid vaccine 19 mRNA anaphylaxis with 2nd dose and acute hives with 1st dose of Pfizer vaccine S/p repeated doses of epipen   With ongoing asthma, dizziness, light headed , nausea  and fast heart rate 1.5 weeks after anaphylaxis but normotensive With prior history of delayed hives with gardisil  --may be sensitive to polysorbate 80 in both vaccines. Added COVID vaccine to allergy list
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Genital blister, Headache, Myalgia, Pain
Clinical narrative: Fever, headache, muscle pain, abdominal pain and what really worries me is that all these symptoms have disappeared. But I have a kind of blister on my genitals and that has not disappeared. All the symptoms appeared the same day I received the second dose of the vaccine (in the first dose I received I did not have any problems or strange symptoms), except for the blister that appeared two days later.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, headache, muscle pain, abdominal pain and what really worries me is that all these symptoms have disappeared. But I have a kind of blister on my genitals and that has not disappeared. All the symptoms appeared the same day I received the second dose of the vaccine (in the first dose I received I did not have any problems or strange symptoms), except for the blister that appeared two days later.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash on back of right arm, left arm, left thigh, right thigh, both feet and arms.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Neck pain, Pain, Pyrexia
Clinical narrative: Vaccinated on February 13, 2021. About 2 hours after the vaccine Left  shoulder  started to get sore. The next day at around 3:00 AM body aches, neck pain, severe head ache and fever started to rise. The highest temperature noted was 101.7 Fahrenheit. On February  17,2021 around noon time,  hives or  itchy rashes started to appear on the neck, body and arms. Up to this day there are still hives or rashes present. Headaches is starting to diminish and less intense in nature and no Fever anymore.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Vaccinated on February 13, 2021. About 2 hours after the vaccine Left  shoulder  started to get sore. The next day at around 3:00 AM body aches, neck pain, severe head ache and fever started to rise. The highest temperature noted was 101.7 Fahrenheit. On February  17,2021 around noon time,  hives or  itchy rashes started to appear on the neck, body and arms. Up to this day there are still hives or rashes present. Headaches is starting to diminish and less intense in nature and no Fever anymore.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Pyrexia
Clinical narrative: Weakness, dizziness, fever
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: First dose: just a little itchy arm day 2. Second dose: 26 hours post dose very tired, sore muscles,chills,headache,insomnia. 42 hours post dose left arm at injection site very red 6inches by 4 inches, hot to touch, painful, itchy
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pruritus, Injection site warmth, Insomnia, Myalgia, Pruritus
Clinical narrative: First dose: just a little itchy arm day 2. Second dose: 26 hours post dose very tired, sore muscles,chills,headache,insomnia. 42 hours post dose left arm at injection site very red 6inches by 4 inches, hot to touch, painful, itchy
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Erythema, Eye pruritus, Eye swelling
Clinical narrative: a hx of Hashimoto Thyroiditis and Monoarthritis of the left knee received Covid Moderna Vaccine on 1/13/21. Developed chills, then joint pain, headaches and on 1/15 swelling around face and eyes. 1/19/21 Eyes are still itchy and had been taking Benadryl for it. Had video visit with MD, changed to Zyrtec and also refresh tears to the eyes but sx's not getting better with redness and itchiness.  Pt put hydrocortisone cream under her eyes and SX's got better.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Swelling face
Clinical narrative: a hx of Hashimoto Thyroiditis and Monoarthritis of the left knee received Covid Moderna Vaccine on 1/13/21. Developed chills, then joint pain, headaches and on 1/15 swelling around face and eyes. 1/19/21 Eyes are still itchy and had been taking Benadryl for it. Had video visit with MD, changed to Zyrtec and also refresh tears to the eyes but sx's not getting better with redness and itchiness.  Pt put hydrocortisone cream under her eyes and SX's got better.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Chills, Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: Injection on 1/27-- On 1/28 chills, no temp, pain in left arm including injection site, underarm and left chest, extreme fatigue and though intake was limited excessive urination was noted. 2/11 heart noted to be above 120 at home to ER where heart rate was over 110.Shortness of air with increased heart rate.  2/15 Resting heart rate remained elevated and left side chest and arm pain.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Pain in extremity, Pollakiuria
Clinical narrative: Injection on 1/27-- On 1/28 chills, no temp, pain in left arm including injection site, underarm and left chest, extreme fatigue and though intake was limited excessive urination was noted. 2/11 heart noted to be above 120 at home to ER where heart rate was over 110.Shortness of air with increased heart rate.  2/15 Resting heart rate remained elevated and left side chest and arm pain.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Acute CVA
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Pain in extremity
Clinical narrative: Arm soreness , myalgia, fatigue, headaches
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction, Rash erythematous, Skin warm, Swelling
Clinical narrative: Baseball sized red circular rash appeared at the site of injection 2 days after 2nd vaccine.  The area is reddish, a little swollen and warm to the touch.  The shot was given to the right arm.     The same type of rash appeared at the site of injection a week after the 1st vaccine dose.  (Moderna Lot 029L20A) It took about 6 days for the rash to disappear after the first vaccine dose.  The first vaccine was also given in the right  arm.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphonia, Dysstasia, Feeling drunk, Headache
Clinical narrative: 10:18 am pt reported feeling dizzy and developing a headache. PT was monitored for a period of time, around 10:55 pt complained of tickle in throat and feeling drunk.  At 11:00am pt complained of tingling in hands and feet,  had difficulty standing  without swaying, her voice became raspy, she complained of some tightness in the throat. At this point Epinephrine 0.3 mg (epi-pen) was given. Patient was transferred to the hospital via ambulance.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Throat irritation, Throat tightness
Clinical narrative: 10:18 am pt reported feeling dizzy and developing a headache. PT was monitored for a period of time, around 10:55 pt complained of tickle in throat and feeling drunk.  At 11:00am pt complained of tingling in hands and feet,  had difficulty standing  without swaying, her voice became raspy, she complained of some tightness in the throat. At this point Epinephrine 0.3 mg (epi-pen) was given. Patient was transferred to the hospital via ambulance.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Disturbance in attention, Dizziness, Dysphonia, Dyspnoea
Clinical narrative: 10:18 am pt reported feeling dizzy and developing a headache. PT was monitored for a period of time, around 10:55 pt complained of tickle in throat and feeling drunk.  At 11:00am pt complained of tingling in hands and feet,  had difficulty standing  without swaying, her voice became raspy, she complained of some tightness in the throat. At this point Epinephrine 0.3 mg (epi-pen) was given. Patient was transferred to the hospital via ambulance.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Feeling drunk, Immediate post-injection reaction, Magnetic resonance imaging, Paraesthesia
Clinical narrative: 10:18 am pt reported feeling dizzy and developing a headache. PT was monitored for a period of time, around 10:55 pt complained of tickle in throat and feeling drunk.  At 11:00am pt complained of tingling in hands and feet,  had difficulty standing  without swaying, her voice became raspy, she complained of some tightness in the throat. At this point Epinephrine 0.3 mg (epi-pen) was given. Patient was transferred to the hospital via ambulance.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness, X-ray
Clinical narrative: 10:18 am pt reported feeling dizzy and developing a headache. PT was monitored for a period of time, around 10:55 pt complained of tickle in throat and feeling drunk.  At 11:00am pt complained of tingling in hands and feet,  had difficulty standing  without swaying, her voice became raspy, she complained of some tightness in the throat. At this point Epinephrine 0.3 mg (epi-pen) was given. Patient was transferred to the hospital via ambulance.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dysphonia, Dysstasia, Feeling drunk, Headache
Clinical narrative: tingling hands and feet within 3 min of injection dizzy with in 5 min of injection loss of concentration within 10 min of injection overall feeling of being drugged or drunk with in 10min of injection  throat tightening and voice change hard to breathe   (15 to 20 min after injection) epi pen injection and transport to emergency room via ambulance ( 30-45min after injection)
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Paraesthesia, Throat irritation, Throat tightness
Clinical narrative: tingling hands and feet within 3 min of injection dizzy with in 5 min of injection loss of concentration within 10 min of injection overall feeling of being drugged or drunk with in 10min of injection  throat tightening and voice change hard to breathe   (15 to 20 min after injection) epi pen injection and transport to emergency room via ambulance ( 30-45min after injection)
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Disturbance in attention, Dizziness, Dysphonia, Dyspnoea
Clinical narrative: tingling hands and feet within 3 min of injection dizzy with in 5 min of injection loss of concentration within 10 min of injection overall feeling of being drugged or drunk with in 10min of injection  throat tightening and voice change hard to breathe   (15 to 20 min after injection) epi pen injection and transport to emergency room via ambulance ( 30-45min after injection)
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Feeling drunk, Immediate post-injection reaction, Magnetic resonance imaging, Paraesthesia
Clinical narrative: tingling hands and feet within 3 min of injection dizzy with in 5 min of injection loss of concentration within 10 min of injection overall feeling of being drugged or drunk with in 10min of injection  throat tightening and voice change hard to breathe   (15 to 20 min after injection) epi pen injection and transport to emergency room via ambulance ( 30-45min after injection)
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Throat tightness, X-ray
Clinical narrative: tingling hands and feet within 3 min of injection dizzy with in 5 min of injection loss of concentration within 10 min of injection overall feeling of being drugged or drunk with in 10min of injection  throat tightening and voice change hard to breathe   (15 to 20 min after injection) epi pen injection and transport to emergency room via ambulance ( 30-45min after injection)
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Headache, Myalgia
Clinical narrative: diarrhea, chills, headache, myalgias for 3 weeks post vaccination
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Blood pressure increased, Cardiac monitoring normal, Chest X-ray normal, Chest discomfort
Clinical narrative: Received vaccine at 5:05pm and waited allotted 15 minutes. Twenty minutes after receiving vaccine,  developed palpitations, chest pressure, feeling flushed and anxious, nausea, tingling on left side of body and face, elevated blood pressure, and slight dizziness while driving home. Was seen at ER a few hours later;  cardiac workup was done with CXR, bloodwork, EKG and heart monitoring and was treated with Benadryl IV. Was sent home for 2 days out of work and instructed to take Benadryl as needed.