chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling hot, Flushing, Head discomfort, Paraesthesia
Clinical narrative: Allergic reaction:  About 5 minutes after the shot I started feeling flush and I turned blotchy red on my face, neck, chest, and arms. That flushing was followed quickly by mild shortness of breath, an overwhelming feeling of being so hot, a heavy-headed feeling, chest tightness, face and scalp tingling, confusion, hand tremors, and tightness in my throat. This all started during the 15-minute observation period. I raised my hand to report my symptoms, and the onsite nurses took me to a private area to monitor me. My heart rate was quite high (tachycardia) and my blood pressure was very elevated at 184/116. They gave me 50mg of benadryl and continued to check my heart rate and blood pressure. After 30 more minutes, my vitals still weren't really improving nor were my other symptoms, so the decision was made to call paramedics and have me transported to the emergency department for further evaluation/observation. After 30mg zyrtec, 50mg benadryl, 40mg famotidine, and 3 hours, I was feeling much better. My blood pressure was still elevated and my pulse pressure was quite wide, but my heart rate and other symptoms were improved so I was discharged to home, where I pretty quickly fell into a 3-hour deep slumber. I awoke still feeling shakey and confused. The confusion continued throughout the next day. It has finally subsided on day 3.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pulse pressure increased, Rash macular, Tachycardia, Throat tightness, Tremor
Clinical narrative: Allergic reaction:  About 5 minutes after the shot I started feeling flush and I turned blotchy red on my face, neck, chest, and arms. That flushing was followed quickly by mild shortness of breath, an overwhelming feeling of being so hot, a heavy-headed feeling, chest tightness, face and scalp tingling, confusion, hand tremors, and tightness in my throat. This all started during the 15-minute observation period. I raised my hand to report my symptoms, and the onsite nurses took me to a private area to monitor me. My heart rate was quite high (tachycardia) and my blood pressure was very elevated at 184/116. They gave me 50mg of benadryl and continued to check my heart rate and blood pressure. After 30 more minutes, my vitals still weren't really improving nor were my other symptoms, so the decision was made to call paramedics and have me transported to the emergency department for further evaluation/observation. After 30mg zyrtec, 50mg benadryl, 40mg famotidine, and 3 hours, I was feeling much better. My blood pressure was still elevated and my pulse pressure was quite wide, but my heart rate and other symptoms were improved so I was discharged to home, where I pretty quickly fell into a 3-hour deep slumber. I awoke still feeling shakey and confused. The confusion continued throughout the next day. It has finally subsided on day 3.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neuropathy peripheral
Clinical narrative: diabetic peripheral neuropathy which was hitting her hard right now; diabetic peripheral neuropathy which was hitting her hard right now; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunisation. Medical history included ongoing diabetic peripheral neuropathy. Concomitant medication included calcium mefolinate, pyridoxine hydrochloride, vitamin b12 nos (METANX) from unspecified date and ongoing for diabetic peripheral neuropathy. The patient previously received first single dose of BNT162B2 on an unspecified date for COVID-19 immunisation. It was reported that she just had her second dose on 08Feb2021 Monday. She was wondering if she could now take her METANX which was a diabetic medication. She said she didn't stop the medication, hadn't needed it for a long time, it was for her diabetic peripheral neuropathy which was hitting her hard right now. She would like to take a pill if it wouldn't hurt the vaccine. Outcome of the event was unknown.   Information on lot /batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Diabetic neuropathy
Clinical narrative: diabetic peripheral neuropathy which was hitting her hard right now; diabetic peripheral neuropathy which was hitting her hard right now; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that a female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 08Feb2021 at single dose for COVID-19 immunisation. Medical history included ongoing diabetic peripheral neuropathy. Concomitant medication included calcium mefolinate, pyridoxine hydrochloride, vitamin b12 nos (METANX) from unspecified date and ongoing for diabetic peripheral neuropathy. The patient previously received first single dose of BNT162B2 on an unspecified date for COVID-19 immunisation. It was reported that she just had her second dose on 08Feb2021 Monday. She was wondering if she could now take her METANX which was a diabetic medication. She said she didn't stop the medication, hadn't needed it for a long time, it was for her diabetic peripheral neuropathy which was hitting her hard right now. She would like to take a pill if it wouldn't hurt the vaccine. Outcome of the event was unknown.   Information on lot /batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chalazion, Fatigue, Headache, Injection site erythema, Injection site induration
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Weakness-Mild
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site swelling, Neuralgia, Swelling of eyelid
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Weakness-Mild
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dizziness, Headache, Injection site bruising, Injection site erythema
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Weakness-Mild
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Pain, Pruritus
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Weakness-Mild
Age: 72.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling face, Swollen tongue
Clinical narrative: Site: Bruising at Injection Site-Severe, Site: Itching at Injection Site-Severe, Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Swelling of Face / Eyes / Mouth / Tongue-Severe, Systemic: Body Aches Generalized-Severe, Systemic: Dizziness / Lightheadness-Severe, Systemic: Headache-Severe, Systemic: Weakness-Mild
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dry mouth, Dyspepsia, Fatigue, Taste disorder
Clinical narrative: I've had too much stomach upset; Severe heartburn; Persistent mouth dryness; The taste in my mouth changed; Extreme fatigue; This is a spontaneous report from contactable healthcare professional. A 35-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date unspecified), via an unspecified route of administration on 27Jan2021 09:15 at single dose (left arm) for COVID-19 immunization. The patient medical history was not reported. The patient had no known allergies. The patient was not pregnant. There were no concomitant medications. The patient had no other vaccine in other 4 weeks. On 28Jan2021, at 12:00, the patient experienced too much stomach upset, severe heartburn, persistent mouth dryness, the taste in mouth changed and extreme fatigue. The patient received therapy for the events included household medication and natural treatment. The patient did not have covid prior vaccination and was not covid tested post vaccination. Outcome of events was not recovered.   Information on the batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Fatigue; muscle aches; headache; This is a spontaneous report from a contactable consumer (the patient). A patient of an unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date (age at vaccination unknown) as a single dose for COVID-19 immunization. On an unspecified date after the second dose, the patient experienced fatigue, muscle aches, and headache. The clinical outcome of fatigue, muscle aches, and headache was unknown.   No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Weight
Clinical narrative: Dizziness; This is a spontaneous report from a contactable consumer, based on information received by Pfizer from Bristol-Myers Squibb (manufacturer control number: US-BRISTOL-MYERS SQUIBB COMPANY-BMS-2021-016013), license party for apixaban (ELIQUIS).  This case was received via Pfizer Inc (Reference number: 2021162914) on 15-Feb-2021 and was forwarded to BMS on 16-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of dizziness in 65-year-old male patient who received apixaban (ELIQUIS) for venous thromboembolism. Co-suspect products included covid-19 vaccine for covid-19 immunisation. Patient weight was reported as approximately between 185-190 (Units not specified). The patient's past medical history included Open heart surgery (had two open heart surgeries. Believes first one was 2002 or 2004, second was 5 years ago, sometime in 2016) and COVID-19 in November 2020. Concurrent medical conditions included Diabetes and Coronary artery disease in 2002. In November 2020, the patient started ELIQUIS (unknown route), 5 milligrams twice a day. On 14-Feb-2021, the patient started covid-19 vaccine (unknown route). On the same day, the patient experienced dizziness. The dose of ELIQUIS (unknown) was not changed. At the time of the report, dizziness did not resolve. For ELIQUIS (unknown), the reporter did not provide any causality assessments. About three hours after getting covid shot patient felt dizziness. It was like he was disoriented or something. It was like his equilibrium was off. He was off balance with it. He is not 100 percent balanced. Patient got Flu Shot, Pneumonia shot previously. No prior vaccinations within 4 weeks. Further follow up was not performed, as sufficient data reported.  Causality Assessment: Drug: ELIQUIS Dizziness Per Reporter = No Information Per Company (Bristol-Myers Squibb) = Related
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypoxia
Clinical narrative: increased need for oxygen; difficulty breathing; A spontaneous report was received from a consumer concerning a 85 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events needing additional oxygen (PT: Hypoxia) and difficulty breathing (PT: Dyspnoea).  The patient's medical history was not provided. No relevant concomitant medications were reported.     On 30 Jan 21, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for the COVID-19 infection prophylaxis.   On an unknown date, the patient experienced increase difficulty breathing and increased need for oxygen. Treatment included oxygen.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the events, needing additional oxygen and difficulty breathing, were unknown/not reported.; Reporter's Comments: This case concerns an 85-year-old female who experienced a serious unexpected event of HYPOXIA along with a nonserious unexpected event of DYSPNOEA.  The events occurred with unknown latency after the first dose of mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Adrenocortical insufficiency acute
Clinical narrative: acute adrenal crisis; A spontaneous report was received from a Physician regarding his son who received second dose of Moderna Covid-19 vaccine and have experienced acute adrenal crisis.  The patient's medical history was not provided. His concomitant medications were not provided. No information on allergies.   On 11-FEB-2021, prior to the onset of events, the patient received second of two planned doses of Covid-19 vaccine for the prophylaxis of Covid-19 infection. Patient lives in a group home. On an unspecified date, he seemed to be confused, disoriented and unable to talk. Father met him at Emergency department where the patient had an acute adrenal crisis , and after ruling out stroke ,he was diagnosed with Addison's disease(loss of adrenal function). He was admitted and discharged after two days. Post discharge, he seemed totally normal.  Action taken with the vaccine is not applicable as the patient received both the doses.  The outcome of the event acute adrenal crisis is considered recovered at the time of report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: Sepsis; A spontaneous report was received from a consumer of unknown age and gender, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sepsis.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On an unknown date, the patient received a dose (first or second dose not specified) of mRNA-1273 (Batch number not provided) for prophylaxis of COVID-19 infection.  On an unknown date, the patient  was reportedly rushed to the hospital for sepsis (details not provided). Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, sepsis was not reported.; Reporter's Comments: Very limited information regarding the events has been provided at this time and is insufficient for causality assessment.
Sex: U
Vaccine: COVID19
Symptoms: Polymyalgia rheumatica, Vaccination complication
Clinical narrative: Developed PMR; negative effect; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events( vaccination complication i.e., polymyalgia rheumatica) list.  The patient's medical history was not provided. No relevant concomitant medications were reported.  on unknown date, prior to the onset of the events, the patient received mRNA vaccine for prophylaxis of COVID-19 infection.  on unknown date, the patient experienced the events list (polymyalgia rheumatica) with seriousness criteria.  Laboratory details are not provided.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  The outcome of the event was not reported.; Reporter's Comments: Very limited information regarding these events has been provided at this time.  Further information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Haematochezia
Clinical narrative: bloody stools; A spontaneous report was received from an unknown reporter concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273), experienced bloody stools for 2 days.  The patient's medical history was not provided. Concomitant product use was not provided/unknown by the reporter.    On 05-JAN-2021, the patient received their first of two planned doses of mRNA-1273 (Batch number: 025L20A) for prophylaxis of COVID-19 infection.     Patient reported to the nurse at his second Moderna vaccine appointment that he had bloody stools for 2 days, and then the bloody stools stopped. Treatment information was not provided/unknown.    Action taken with mRNA-1273 in response to the event(s) was not provided/unknown.  The event, blood stools for 2 days , was recovered/resolved on an unknown date.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Loss of consciousness, Malaise, Nausea, Vaccination site pain
Clinical narrative: Passed out and fell on the bathroom floor; didn't feel well; Passed out and fell on the bathroom floor; Nauseated; Arm was sore; A spontaneous report was received from a consumer concerning a 68-years-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) experienced arm was sore, nauseated, didn't feel well, passed out and fell on the bathroom floor.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 12 Feb 2021, approximately one day prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On 13 Feb 2021, the patient experienced sore arm, not feeling well, nausea, passed out and fell on the bathroom floor. Treatment information was not provided.    Action taken with mRNA-1273 in response to the events was not provided.  The outcome of the events arm was sore, nauseated, didn't feel well, passed out and fell on the bathroom floor were unknown.; Reporter's Comments: This case concerns a 68-year-old female who experienced serious unexpected events of Loss of consciousness, along with nonserious unexpected malaise and fall and NS expected vaccination site pain and nausea.  The events occurred 2 days after the first dose of mRNA-1273. Treatment not reported. Event outcome unknown.  Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Headache, Heart rate increased, Hypertension, Rash pruritic
Clinical narrative: Blood pressure 170/120; Fast heart rate; Rash on her arm that spread across her body, rash felt itchy and hot; Rash felt itchy and hot; Headache; A spontaneous report was received from a consumer concerning, a 48-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced fast heart rate, BP:170/120, rash spread from arm to her body, rash felt hot and headache.  The patient's medical history was not provided. No relevant concomitant medications were reported.   On 22 Jan 2021, 1 day prior to onset of the events fast heart rate, BP:170/120, rash spread from arm to her body, rash felt hot and headache, patient received their dose of mRNA-1273 (lot/batch: 029L420A) intramuscularly for prophylaxis of COVID-19 infection.    On 22 Jan 2021, the patient had medically significant events of increased heart rate, BP:170/120, rash spread from arm to her body, rash felt itchy and hot and non serious event of headache.  The patient stayed at the ER (emergency room) for 3 hours.  Treatment included diphenhydramine.   Action taken with mRNA-1273 in response to the events was not reported.     The outcome of events increased heart rate, BP:170/120, rash spread from arm to her body, rash felt itchy and hot was recovered on 22 Jan 2021. The outcome of the event headache was not recovered.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; A spontaneous report was received from a Consumer and Other HCP  concerning a  84Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced event like Stroke.      The patient's medical history provided no adverse event. Relevant concomitant medications were reported like atorvastatin calcium, ezetimibe, niacin, metoprolol, acetylsalicylic acid, levothyroxine sodium, and iron supplement.  On 4th Feb 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 038k20a) intramuscularly in the left arm for prophylaxis of COVID-19 infection.   On date 5th Feb 2021, The patient experienced the event like Stroke, which required hospitalization. It was noted the patient's speech was getting better, but the left side of his body was still paralyzed. There was no treatment information provided  There were no laboratory details provided.   Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event is unknown.; Reporter's Comments: Although a temporal association exit, provided information is not adequate to assess the causal association between the event and mRNA-1273.  Critical details such as the medical history and diagnostic report is lacking. Causality is also confounded by the patient's advanced age and suspected cardiac related condition (patient is on antihypertensive noted in conmed)
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Body temperature, COVID-19, COVID-19 pneumonia, Hypotension
Clinical narrative: Blood pressure dropped to 94/34; Covid related pneumonia; Covid-19; A spontaneous report was received from a consumer concerning 90 year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, blood pressure dropped to 94/34 (hypotension), COVID-19 (Covid-19), and COVID related pneumonia (COVID-19 pneumonia).  The patient's medical history was not provided. No relevant concomitant medications were reported.    On 23-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 032L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection.  On 04-Feb-2021, the patient experienced the events, blood pressure dropped to 94/34 (hypotension), body temperature was 101.0 0F (Fever), COVID-19 (Covid-19), and COVID related pneumonia (COVID-19 pneumonia).The patient was hospitalized on the same day (04-Feb-2021) and discharged on 12-Feb-2021 post treatment. Blood pressure dropped to 94/34 mmHg and body temperature was 101.0 0F during hospital admission on 04-Feb-2021. Treatment for the event included remdesivir, ceftriaxone, azithromycin, and oxygen therapy.  Action taken with mRNA-1273 in response to the events was not reported.   At the time of this report, the outcome of the events, blood pressure dropped to 94/34, COVID-19, and COVID related pneumonia, were considered resolved on 12-Feb-2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Swollen and painful lymph nodes in the left arm where the shot was received.; Swollen and painful lymph nodes in the left arm where the shot was received.; This is a spontaneous report from a contactable healthcare professional (patient). A 20-year-old female patient started received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration at the left arm on 07Jan2021 12:30 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient experienced swollen and painful lymph nodes in the left arm where the shot was received on 09Jan2021 13:00. Happened after the first dose and the second dose and have not left. The patient did not received any treatment for the events. The patient underwent lab tests and procedures which included COVID-19 test Nasal Swab: unknown results on 30Jan2021. The outcome of the events was not recovered.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Urticaria
Clinical narrative: Hives all over my body; Severe abdominal pain; This is a spontaneous report from a contactable other healthcare professional (patient). A 35-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, lot/batch number and expiry date unknown), intramuscular on 06Jan2021 13:00 at a single dose for COVID-19 immunization. The patient's medical history was reported as none. The patient's concomitant medications were not reported. The patient experienced hives all over her body and severe abdominal pain on 07Jan2021. The patient received treatment for the events. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. The outcome of the events were recovered on an unspecified date. The events were reported as non-serious. No seriousness criteria provided. The facility where the most recent COVID-19 vaccine was administered was in the hospital.  Information on the lot/batch number has been requested.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site soreness; This is a spontaneous report from a contactable consumer (Patient).  A 44-year-old (also age at vaccination) male patient receive the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EL1283), via an unspecified route of administration at the left arm on 09Jan2021 (reported as 29Jan2021; pending clarification) 08:30 at SINGLE DOSE for covid-19 immunization. Medical history included that prior to vaccination the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had no allergies to medications, food, or other products. The patient was vaccinated at a workplace clinic. The patient's concomitant medications were not reported. It was reported that the patient experienced injection site soreness on 30Jan2021 (as reported date: pending clarification). The outcome of the event was recovering. The treatment received is Diclofenac 100mg. Case was not considered serious (for any criteria).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Lymphadenopathy, Myalgia
Clinical narrative: Significant swelling in left axillary lymph node; fever up to 102.7 F/low grade temp in low-mid 100s; Severe chills; fatigue; Moderate muscle aches; This is a spontaneous report from a contactable nurse (patient).  A 28-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date unknown) in the hospital, via an unspecified route of administration on 28Jan2021 at 15:00 on the left arm at a single dose for COVID-19 immunization. Medical history included allergies to penicillin and sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol, norgestimate (ESTARYLLA) for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 (lot number: EL1284, expiry date unknown) on 06Jan2021 at 12:00 PM on the left arm for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient experienced fever up to 102.7 F lasting from 05:00 on 29Jan2021 to 01:00 on 30Jan2021. The patient took 3 doses of 1000 mg Tylenol during this time period which would bring temp down to high 100s for an hour or two. After 01:00 on 30Jan2021, the patient had low grade temp in low-mid 100s until the afternoon. The patient also experienced severe chills, fatigue, moderate muscle aches on 29Jan2021 at 05:00. The patient had significant swelling in left axillary lymph node starting on the evening of 30Jan2021.  The patient received treatment for the event fever but did not receive treatment for the other events. The outcome of the events was recovering. The events were reported as non-serious.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Significant swelling in left axillary lymph node; fever up to 102.7 F/low grade temp in low-mid 100s; Severe chills; fatigue; Moderate muscle aches; This is a spontaneous report from a contactable nurse (patient).  A 28-year-old female patient received the second dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EL3248, expiry date unknown) in the hospital, via an unspecified route of administration on 28Jan2021 at 15:00 on the left arm at a single dose for COVID-19 immunization. Medical history included allergies to penicillin and sulfa drugs. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included ethinylestradiol, norgestimate (ESTARYLLA) for birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received the first dose of BNT162B2 (lot number: EL1284, expiry date unknown) on 06Jan2021 at 12:00 PM on the left arm for COVID-19 immunization. Since the vaccination, the patient has not been tested for COVID-19. It was reported that the patient experienced fever up to 102.7 F lasting from 05:00 on 29Jan2021 to 01:00 on 30Jan2021. The patient took 3 doses of 1000 mg Tylenol during this time period which would bring temp down to high 100s for an hour or two. After 01:00 on 30Jan2021, the patient had low grade temp in low-mid 100s until the afternoon. The patient also experienced severe chills, fatigue, moderate muscle aches on 29Jan2021 at 05:00. The patient had significant swelling in left axillary lymph node starting on the evening of 30Jan2021.  The patient received treatment for the event fever but did not receive treatment for the other events. The outcome of the events was recovering. The events were reported as non-serious.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pruritus, Headache, Hypersensitivity, Pruritus
Clinical narrative: Moderate allergic reaction; itchy skin; itchy eyes; Headache; This is a spontaneous report from a contactable consumer. An 80-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 9263), via an unspecified route of administration in right arm on 24Jan2021 11:45 at a single dose for COVID-19 immunization. Medical history included Diabetes2, HiBloodPress and HiCholesterol. Concomitant medication included lisinopril, simvastatin, and unspecified diabetes medication. On 26Jan2021, the patient experienced moderate allergic reaction, itchy skin, itchy eyes and headache. The patient was taking antihistamines with some relief for moderate allergic reaction, itchy skin, itchy eyes. There was no treatment for headache. The outcome of the events was recovering. Prior and since the vaccination, the patient was not tested for COVID-19. The events were assessed as non-serious.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia, Vaccination site pain
Clinical narrative: Injection site pain; Fever of 101.3; Tired; Headache; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3248, expiry date: unknown), via an unspecified route of administration on 18Jan2021 20:00 (at the age of 56 years old), at a single dose in the left arm for covid-19 immunisation. Medical history included allergies: dust, mold, trees & grass; and diagnosed with covid-19 on unspecified date. Concomitant medications included escitalopram oxalate (LEXAPRO) and fexofenadine hydrochloride (ALLEGRA 24 HOUR). The patient previously took augmentin and experienced allergies. The patient is not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient has not been tested for covid-19 since the vaccination. On 19Jan2021 20:00, the patient experienced injection site pain for seven days and fever of 101.3 which lasted for 12 hours; tired and had a headache for two days. The patient did not receive any treatment for all the events. Outcome of all the events was recovered on unspecified date. The events were reported as non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood test, Dizziness
Clinical narrative: she experienced dizziness and weakness; she experienced dizziness and weakness; This is a spontaneous report from a contactable consumer (patient) via the medical information team. A 70-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot: EL9262, expiry: May2021), via an unspecified route of administration (at the age of 70years) on 27Jan2021 at single dose for covid-19 immunisation. Medical history included hypertension and Crohn's. Concomitant medications included lisinopril, estradiol, levothyroxine and adalimumab (HUMIRA) for Crohn's. The patient received the first dose of the Pfizer-BioNtech Covid-19 vaccine on Wednesday. Next morning (on 28Jan2021) from Thursday until Saturday, she experienced dizziness and weakness as stated, "when I woke I was severely dizzy and just weak and that is continued yesterday, well let's say Thursday, Friday and yesterday. I am feeling better today but I wanted to report that". The patient wanted to know if she should receive the second dose of the vaccine because these two symptoms were reported as signs of a severe allergic reaction and that's a contraindication to receive the second dose of the vaccine. The patient had some blood work done on an unspecified date. The patient took some diphenhydramine hydrochloride (BENADRYL) according to her physician. The patient further stated, "I am just, I guess concerned, it does say on the paperwork that I received that you should not take the second dose if you had a severe allergic reaction which it list the dizziness and weakness one of those included so I am assuming that I should not take the second dose." The patient considered the events as non-serious. The outcome of the events was recovering.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Cough
Clinical narrative: Coughing; loss of taste and smell; loss of taste and smell; This is a spontaneous report from a contactable consumer (reporting for himself). A 42-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Solution for injection (lot number: EL3302, expiration date unknown) via an unspecified route of administration in the left arm on 25Jan2021 (at 42 years old) at a SINGLE DOSE for COVID-19 immunization. The patient received the vaccine at a Hospital, reported as "Military Base." The patient had no medical history and had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with COVID prior to vaccination, did not receive any other vaccines within 4 weeks prior to BNT162B2, and has not been tested for COVID since the vaccination. On 26Jan2021, the patient experienced coughing, loss of taste and smell. The adverse events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if patient treatment for the adverse events. Outcome of the events was not recovered. The events were reported as non-serious.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Influenza like illness, Night sweats
Clinical narrative: flu-like symptoms; headache; aches; chills; night sweats; more fatigue than normal; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration in the left arm on 17Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included Seizure disorder, depression, anxiety, mild hyperthyroidism and Penicillin allergy. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included carbamazepine, citalopram, buspirone hydrochloride (BUSPAR), and omeprazole. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced flu-like symptoms, headache, aches, chills, night sweats, and more fatigue than normal on 17Dec2020 19:00. Treatment was not provided in response to the events. The outcome of the events was recovered on an unspecified date. The reporter assessed the events as non-serious. The patient has not been tested for COVID-19 since the vaccination.   Information on the lot/batch number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: flu-like symptoms; headache; aches; chills; night sweats; more fatigue than normal; This is a spontaneous report from a contactable nurse (patient). A 41-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not provided), via an unspecified route of administration in the left arm on 17Dec2020 16:30 at a single dose for COVID-19 immunization. Medical history included Seizure disorder, depression, anxiety, mild hyperthyroidism and Penicillin allergy. The patient was not diagnosed with COVID-19 prior to the vaccination. The patient is not pregnant at the time of vaccination. Concomitant medication included carbamazepine, citalopram, buspirone hydrochloride (BUSPAR), and omeprazole. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. The patient experienced flu-like symptoms, headache, aches, chills, night sweats, and more fatigue than normal on 17Dec2020 19:00. Treatment was not provided in response to the events. The outcome of the events was recovered on an unspecified date. The reporter assessed the events as non-serious. The patient has not been tested for COVID-19 since the vaccination.   Information on the lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Blood pressure measurement, Chest discomfort
Clinical narrative: I am an asthmatic.  Fine until 25 mins. after vaccine then tightness in chest that lasted about 45-60 mins.  Next day asthma had started.; I am an asthmatic.  Fine until 25 mins. after vaccine then tightness in chest that lasted about 45-60 mins.  Next day asthma had started.; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: LL3248, expiry date not reported), via an unspecified route of administration at the right arm on 25Jan2021 09:00 at single dose for COVID-19 immunization. Medical history included allergies, chronic asthma, immune deficiency, high blood pressure, allergic to injections and infusions. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. Concomitant medications were not reported. On 25Jan2021 09:00, the patient stated that she was an asthmatic. She was fine until 25 mins. After vaccine, she then experienced tightness in chest that lasted about 45-60 mins. On the next day, asthma had started. She had the vaccine on Monday, and called her physician and requested to come to be checked which she did. The patient underwent lab tests and procedures which included blood pressure measurement: high on an unspecified date. Therapeutic measure was taken for the events that included  Symbicort inhaler. Clinical outcome of the events was recovering.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Pyrexia
Clinical narrative: Fever; Headache; Lightheaded; This is a spontaneous report from a contactable consumer. A 27-year-old female patient received bnt162b2 PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 30Jan2021 09:00 at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced Fever, Headache, Lightheaded; all on 31Jan2021 at 05:00 AM. No treatment was received for the events.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling of the lymph nodes (mid neck/clavicle area) in the same arm as the injection.; This is a spontaneous report from a contactable nurse (patient). A 36-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported) (at 36 years of age), via an unspecified route of administration in the left arm on 23Jan2021 10:15 at a single dose for COVID-19 immunization. Medical history included multiple sclerosis (MS) and allergy to nickel. Concomitant medication included interferon beta-1a (AVONEX), buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE), colecalciferol (VITAMIN D [COLECALCIFEROL]), and bupropion hydrochloride (WELLBUTRIN). The patient previously took REGLAN [metoclopramide] and experienced allergy. Historical vaccine included PFIZER BIONTECH COVID 19 VACCINE first dose (at 36 years of age) on 02JAN2021 08:30 AM via unknown route of administration in the left arm for COVID-19 immunization. The patient was not pregnant. She had not had other vaccine in four weeks prior to covid vaccine. She had no covid prior vaccination and she was not tested for covid post vaccination. The patient experienced swelling of the lymph nodes (mid neck/clavicle area) in the same arm as the injection on 25Jan2021 with outcome of recovering. There was no treatment received for the events. The event resulted to Doctor or other healthcare professional office/clinic visit.  Information on the lot/Batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Skin mass
Clinical narrative: left side of neck was very sore; felt a swollen lump /lymph about halfway between my ear and bottom of my neck; This is a spontaneous report from a contactable consumer (Patient). A 48-year-old female patient (also the age at vaccination) received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown: Unable to locate or read the details), via an unspecified route of administration at the left arm on 23Jan2021 12:45 PM at SINGLE DOSE for Covid-19 immunization.  Medical history included Chiari Malformation (reported as other medical history). The patient has no COVID prior to vaccination, also not COVID tested post vaccination. The patient had no known allergies. The patient is not pregnant. There was no other vaccine in four weeks. It was reported that the patient had other medications in two weeks (unspecified). The patient had the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 02Jan2021 at 12:45 PM at the left arm for COVID-19 immunization (Lot number not reported: Unable to locate or read the details, facility type vaccine: Other). It was reported by the patient that: "I woke up this morning (on 31Jan2021 at 08:00 AM) and my left side of neck was very sore. I went to rub it and immediately felt a swollen lump /lymph about halfway between my ear and bottom of my neck. It is about the size of a dime. My second dose was 8 days ago (23Jan2021). I am assuming this is normal response to Pfizer vaccine, but all I read said reactions should be over 2 to 4 days after vaccine. Is this considered normal or should I contact my PCP? " No treatment was received. The outcome of the events was not recovered.   Information about Lot and batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer. A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) first dose, lot number and expiration date unknown, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization and ibuprofen (MOTRIN), via an unspecified route of administration from an unspecified date at 600 mg for an unspecified indication. The patient's medical history and concomitant medications were not reported. The patient took ibuprofen 600mg 1hr before getting 1st dose of vaccine on Wednesday. He only had a sore arm after the 1st dose. The patient read that he should not have taken medication before vaccine. He was asking for information about the vaccine efficacy since he took ibuprofen before the dose. He mentioned that maybe he should stop taking his antihistamine before the next dose. He was most concerned that he messed up the vaccine. The action taken in response to the event for ibuprofen and the outcome of the event was unknown.   Information on the lot/batch number has been requested.