chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Substance use
Clinical narrative: Patient suffered cardiac arrest, though most likely result of illicit substance use; patient had been feeling unwell with nausea and GI discomfort after receiving the vaccine 36 hours prior to; patient had been feeling unwell with nausea and GI discomfort after receiving the vaccine 36 hours prior to; patient had been feeling unwell with nausea and GI discomfort after receiving the vaccine 36 hours prior to; Patient suffered cardiac arrest, though most likely result of illicit substance use; This is a spontaneous report from a contactable physician. A 33-years-old male patient received bnt162b2 (BNT162B2, lot unknown), intramuscular on 14Jan2021 at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient suffered cardiac arrest 17Jan2021 11:15, though most likely result of illicit substance use since Jan2021, though patient had been feeling unwell with nausea and GI discomfort on 15Jan2021 23:15 after receiving the vaccine 36 hours prior to his arrest. The events were serious due to Life threatening illness (immediate risk of death from the event) and Disability or permanent damage. The patient had no COVID prior vaccination. COVID test type post vaccination=Nasal Swab on16Jan2021, test result was Negative. COVID test name post vaccination=Roche Cobas. The event outcome was not recovered. No treatment was received to events.  No follow-up attempts are possible; information on lot/batch number cannot be obtained.; Sender's Comments: Based on temporal association, the causal relationship between bnt162b2 and the events cardiac arrest, substance abuse, abdominal discomfort, malaise and nausea cannot be excluded. The information available in this report is limited and does not allow a medically meaningful assessment. This case will be reassessed once additional information becomes 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: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pyrexia
Clinical narrative: Nauseous; Fever; Chills; Headache; This is a spontaneous report from a contactable consumer (patient). A 46-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration on 08Jan2021 at single dose for covid-19 immunization. Medical history was none. The patient's concomitant medications were not reported. The patient supposed to be calling after she get vaccine to report any side effects. The patient just nauseous, fever, chills, headache. The patient had started symptoms on 09Jan2021 and still had her symptoms today (10Jan2021). The outcome of the events was not recovered.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Chills, Inappropriate schedule of product administration, Pain
Clinical narrative: Chills/shivering; Very slight fever 99.2; Felt a little achy; due date for the next shot: 26Jan2021; This is a spontaneous report from a contactable consumer. This 73-year-old male consumer (patient) reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 08Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure, cholesterol and acid reflux. Concomitant drugs included hydrochlorothiazide for blood pressure, pravastatin sodium (PRAVACHOL) for cholesterol, omeprazole for acid reflux and famotidine (PEPCID) for acid reflux. Patient stated he had chills, shivering, a very slight fever 99.2, and felt a little achy yesterday afternoon (09Jan2021) with outcome of recovered in Jan2021. Patient had blood work with unknown results. Patient took a couple of paracetamol (TYLENOL) as treatment. Patient stated he was told that the side effects would be within 24 hours but this was 2 days later (not confirmed appropriately). It was reported the due date for the next shot: 26Jan2021.  Information on the lot/batch number has been requested.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Chills/shivering; Very slight fever 99.2; Felt a little achy; due date for the next shot: 26Jan2021; This is a spontaneous report from a contactable consumer. This 73-year-old male consumer (patient) reported that he received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 08Jan2021 at single dose for COVID-19 immunization. Medical history included blood pressure, cholesterol and acid reflux. Concomitant drugs included hydrochlorothiazide for blood pressure, pravastatin sodium (PRAVACHOL) for cholesterol, omeprazole for acid reflux and famotidine (PEPCID) for acid reflux. Patient stated he had chills, shivering, a very slight fever 99.2, and felt a little achy yesterday afternoon (09Jan2021) with outcome of recovered in Jan2021. Patient had blood work with unknown results. Patient took a couple of paracetamol (TYLENOL) as treatment. Patient stated he was told that the side effects would be within 24 hours but this was 2 days later (not confirmed appropriately). It was reported the due date for the next shot: 26Jan2021.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This is a spontaneous report from a  non contactable consumer reporting for self.  A patient of unspecified age and gender received bnt162b2 (BNT162B2) vaccine , via an unspecified route of administration on an unspecified date at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced allergic reaction on an unspecified date with outcome of unknown.    No follow-up attempts are possible. No further information is expected. Information about Lot/Batch Number cannot be obtained.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Hypersensitivity
Clinical narrative: allergic reaction; entire forearm turn red; allergic reaction; entire forearm turn red; This is a spontaneous report from a contactable consumer(patient). The 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL2346), Intramuscular (shot in the arm) on 07Jan2021 at single dose for covid-19 immunisation.  The patient medical history included AFib(Atrial fibrillation) and Blood pressure (abnormal), problem with Afib that's pretty under control, blood pressure that's also under control (further not clarified).  Concomitant medication included apixaban (ELIQUIS) and couple of different blood pressure medications.  The patient experienced allergic reaction; entire forearm turned red on 07Jan2021 about 2 hours afterwards vaccination, hydrocortisone as treatment for it, topical rubbed, for about an 1 hour up to. Patient stated that he was not experiencing it and it was the short term thing he had allergic reaction.  Outcome of events was recovered in Jan2021.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Illness, Movement disorder, Nausea, Pain in extremity
Clinical narrative: allergic reaction; Side effects in arm; hurts very badly; Can barely lift my arm; Nausea; really sick like bedridden for 2 days; it's continuing to increase in size and it is red and swollen and hard now; it's continuing to increase in size and it is red and swollen and hard now; it's continuing to increase in size and it is red and swollen and hard now; it's huge and it's purple; This is a spontaneous report from a contactable Other HCP (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142) , via an unspecified route of administration on 10Jan2021 10:30 to at single dose at arm for covid-19 immunisation .  Medical history included spot on arm.  The patient's concomitant medications were not reported.  The patient experienced side effects in my arm and it hurts very badly on 10Jan2021. The patient can barely lift arm. The patient got vaccinated 10Jan2021 around 10:30 and it came up on around 3:30 or 4 o' clock this afternoon. The patient got nauseated but no fever. The Vaccine made patient really sick like bedridden for 2 days. But the spot on arm where patient got the vaccine, it was probably 4 days ago that patient got it and it's continuing to increase in size and it is red and swollen and hard now. The patient reported that this is not like a normal injection site reaction, it's huge and it's purple and red and it feels like bee sting, it feels like an allergic reaction. The outcome of events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Skin discolouration, Vaccination site erythema, Vaccination site induration, Vaccination site swelling
Clinical narrative: allergic reaction; Side effects in arm; hurts very badly; Can barely lift my arm; Nausea; really sick like bedridden for 2 days; it's continuing to increase in size and it is red and swollen and hard now; it's continuing to increase in size and it is red and swollen and hard now; it's continuing to increase in size and it is red and swollen and hard now; it's huge and it's purple; This is a spontaneous report from a contactable Other HCP (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL0142) , via an unspecified route of administration on 10Jan2021 10:30 to at single dose at arm for covid-19 immunisation .  Medical history included spot on arm.  The patient's concomitant medications were not reported.  The patient experienced side effects in my arm and it hurts very badly on 10Jan2021. The patient can barely lift arm. The patient got vaccinated 10Jan2021 around 10:30 and it came up on around 3:30 or 4 o' clock this afternoon. The patient got nauseated but no fever. The Vaccine made patient really sick like bedridden for 2 days. But the spot on arm where patient got the vaccine, it was probably 4 days ago that patient got it and it's continuing to increase in size and it is red and swollen and hard now. The patient reported that this is not like a normal injection site reaction, it's huge and it's purple and red and it feels like bee sting, it feels like an allergic reaction. The outcome of events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: it hurt a little, not much; This is a spontaneous report from a contactable consumer (patient). A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route on 10Jan2021 at single dose for COVID-19 immunization. Concomitant medications and past drug/medical history were not reported. Patient was wondering how long to keep this band aid on this. Patient had done (receiving the Covid-19 vaccine at the hospital) earlier today (10Jan2021) and it was fine and now patient was trying to exercise because it was a problem, it hurt a little, not much on 10Jan2021. Outcome of event was unknown.  Information on the Lot/Batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Eye pain, Headache, Neck pain, Pain
Clinical narrative: Shoulder pain; Body hurting; Headache; Area around my neck hurts really "bad"; My eye hurts; This is a spontaneous report from a contactable consumer (a Certified Nurse Assistant) reporting for herself.  A 36-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Jan2021 at 07:30 at single dose for covid-19 immunisation. Medical history and concomitant medication were none. Patient received the vaccine on 07Jan2021 at around 7:30 in the morning. On an unspecified date in Jan2021, she started developing like really bad shoulder pain and like her body was hurting, and she had like a severe headache and area around her neck hurt really 'bad' (not clarified). She had been taking Tylenol but did not work, nothing seemed improving and what else she could can take for it. Patient stated it was really bad. It didn't even help that much but she was taking. Patient further added she was taking '550 mg' (not clarified) per tablet and it was not working. When probed if still having the problems the patient stated they was just getting worst, and her eye hurt too (Jan2021). Final outcome of the events was reported as not recovered. Second dose of the vaccine was scheduled on 28Jan2021. Information on the Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: arm soreness; This is a spontaneous report from a contactable nurse for brother. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history and concomitant mediations not provided. The patient didn't experience anything else other than the soreness, arm soreness but didn't experience those symptoms (further clarification unknown). The outcome of event was not reported.   Information about lot/batch number has been requested.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: worst case of Hives; Itching all over; This is a spontaneous report from a contactable consumer (patient). A 73-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number: EH9899, Expiry Date: 31Mar2021), via an unspecified route of administration on 09Jan2021 at single dose for covid-19 immunization. Medical history included blood pressure abnormal, thyroid disorder.  Concomitant medication included atenolol for blood pressure, hydrochlorothiazide for blood pressure, levothyroxine for thyroid problems.On 09Jan2021, the patient broke out and got the worst case of hives to the Covid 19 vaccination, she was just itching all over and all over. The patient took diphenhydramine hydrochloride (BENADRYL) and everything and nothing was helping. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Pain, Pyrexia
Clinical narrative: Tired; had fever like 100, I checked around 11:30 I had 99/again in the afternoon I had 100 fever; Body and joints hurts; body ache; This is a spontaneous report from a contactable other HCP (Respiratory therapist, patient). This 50-year-old female patient received 2nd dose of BNT162B2 (COVID-19 Vaccine, Batch/lot number: EL0140) on 08Jan2021 at 9:30 in the morning on Upper Arm Deltoid for COVID-19 immunization. Medical history was Thyroid cancer. Concomitant drug was Levothyroxine for Thyroid cancer. Historical Vaccine was 1st dose of Covid-19 vaccine (Details: LOT#EK5723, Expiration date: Mar2021 (Pfizer). Patient experienced Tired; Body and joints hurts; Body ache, Had fever 100. Consumer stated, "Second one (vaccine) is the one which gave me reaction. (Pfizer)." Event details: I had Covid Vaccination, I did on Friday around 9:30 in the morning and I just want to report that I had a side effect yesterday like a Friday night itself I feel like little bit body ache and yesterday morning. I was so tired body hurts joints are hurting and by afternoon I had fever like 100, I checked around 11:30 I had 99, so I didn't want to take any medication. When I checked again in the afternoon I had 100 fever so I took some Motrin, I just want to report that. Outcome of the event tired was recovering, for other events was recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, on an unspecified date in Dec2020 at single dose for COVID-19 immunisation. Medical history included shingles. Concomitant medications were not reported. Patient got the first COVID Vaccine three weeks ago (Dec2020). Patient supposed to get the second dose tomorrow (11Jan2021). Patient had a previous history of shingles. Patient had shingles that broke out in the meantime. Patient didn't necessarily think it was from vaccine but patient wondered if he/she needed to delay getting the second dose or it is okay to take valaciclovir hydrochloride (VALTREX) and get the dose. When probed for confirmation if got shingles after taking the COVID Vaccine, patient stated, Yes, but it was about two and a half weeks after that he/she started having symptoms (Jan2021), after he/she got the first dose. So, patient did not know if it is from the vaccine or not. Patient had to take the second dose tomorrow and patient just wanted to know if it's safe or if it is not safe then can he/she took valaciclovir hydrochloride and get the vaccine. Patient didn't want to mess up the efficacy or anything. Patient said he/she is a healthcare worker but he/she just couldn't get the information. Patient didn't want to report adverse event, just needed to ask. Patient didn't think it was from the shot, just need to know if it was safe. Outcome of the event was unknown.   Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for COVID; Tested positive for COVID; This is a spontaneous report from a contactable consumer.  A male patient  of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in Dec2020 at single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient tested positive for COVID in Jan2021.  Details were as follows: the patient received the vaccine in Dec2020 (reported as about 14 days or 15 days ago),  and then he tested positive for COVID in Jan2021. Therapeutic measures were taken as a result of the event.  On 09Jan2021, he went and got the monoclonic infusion. The outcome of tested positive for COVID was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Feeling abnormal, Feeling drunk, Head discomfort
Clinical narrative: Weird, strange, unexpected symptoms; Light-headed; Lose headed; Headache; Neck ache; Not feeling well; Very tired; sleeping a lot; if he tried to walk he was like he was going to fall down, like you are just drunk and unable to do anything like that/ Like you are just drunk; unable to do anything like that; This is a spontaneous report from two contactable consumer (patient and patient's wife). A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. Medical history included cardiac failure congestive (CHF), blood pressure problems, Diabetes. The patient's concomiatant medications were not reported. Consumer stated he got the COVID shot on Thursday at (facility name) Hospital in (city name) and he developed some rather weird, strange, unexpected symptoms in Jan2021. He got these symptoms that he was light-headed, lose headed and if he tried to walk he was like he was going to fall down, like you are just drunk and unable to do anything like that. Also he got a bad headache and a neck ache in Jan2021. Consumer's wife stated, he was not feeling well in Jan2021. Wife stated no treatment received, the patient had also been very tired and sleeping a lot and then when he got up, he was like, it's like when you wake up from being drunk but he didn't even drink. He hadn't drank in years. Investigation Assessment was No. The outcome of the events was unknown.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Hypersomnia, Malaise, Neck pain
Clinical narrative: Weird, strange, unexpected symptoms; Light-headed; Lose headed; Headache; Neck ache; Not feeling well; Very tired; sleeping a lot; if he tried to walk he was like he was going to fall down, like you are just drunk and unable to do anything like that/ Like you are just drunk; unable to do anything like that; This is a spontaneous report from two contactable consumer (patient and patient's wife). A 73-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK5730), via an unspecified route of administration on 07Jan2021 at single dose for COVID-19 immunization. Medical history included cardiac failure congestive (CHF), blood pressure problems, Diabetes. The patient's concomiatant medications were not reported. Consumer stated he got the COVID shot on Thursday at (facility name) Hospital in (city name) and he developed some rather weird, strange, unexpected symptoms in Jan2021. He got these symptoms that he was light-headed, lose headed and if he tried to walk he was like he was going to fall down, like you are just drunk and unable to do anything like that. Also he got a bad headache and a neck ache in Jan2021. Consumer's wife stated, he was not feeling well in Jan2021. Wife stated no treatment received, the patient had also been very tired and sleeping a lot and then when he got up, he was like, it's like when you wake up from being drunk but he didn't even drink. He hadn't drank in years. Investigation Assessment was No. The outcome of the events was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Frequent bowel movements, Muscle spasms, Paraesthesia
Clinical narrative: severe cramps/bunch of spasms with legs and arms; quick stools; Wake up probably about an hour, hour and a half then I still feel tired I ended up going back to sleep for another 4 hours; almost like pin pricking; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142) via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included blood pressure, thyroid disorder and hormone level abnormal. Previous vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1685) via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunisation, with no side effects. The concomitant medications was reported Levothyroxine at 5 ug 1x/day for thyroid; atenolol, chlorthalidone (ATENOLOL AND CHLORTHALIDONE) 50/ 25 for Blood pressure; estradiol (ESTRACE) at once a day For hormones. blood pressure management. Patient had second shot on Friday (08Jan2021), she was fine until about 09Jan2021 2:30 in the morning then patient woke up with severe cramps and quick stools, she had about 4 dumps throughout the day she was trying to work and then by 4:30, 5 O'clock patient was having enough drinking water and a whole lot of fluids, stools along with a lot of severe cramping, so she ended up calling in today for work which was definitely not her. Then patient went ahead and she have slept 'many parts of today' (not clarified), she slept like, wake up probably about an hour, hour and a half then she still feel tired ended up going back to sleep for another 4 hours. Patient worked only 3, 3 and a half hours a day because of her health, she had 7 or 8 round so don't normally sleep long but she was healthy. 'Problem is' (voice feeble), now that patient had gotten herself a little more relaxed patient was having a bunch of spasms with legs and arms and almost like pin pricking, so said just to call and let you know she tried but couldn't do it online." Treatment was received for events, took the Tylenol 500 (unit not probed) 1 tablet, took that at 4 O'clock.. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Swelling
Clinical narrative: swelling over my left clavicle; having some swelling over my left clavicle, two lymph nodes; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (lot number: EK5730), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. After patient had a COVID vaccine, a reaction and patient even didn't if it was a reaction, patient was having some swelling over the left clavicle, two lymph nodes which the doctor did analyze. And it was (incomplete sentence), they were not certain with etiology where it was coming from. Patient was supposed to have the second shot this Tuesday, 12Jan2021 (later confirmed) and was a little eerie to have it because of that. Outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Eye haemorrhage
Clinical narrative: Broken blood vessel in eye; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received the 1st dose of bnt162b2 (BNT162B2) at single dose on 21Dec2020 for Covid-19 immunisation.   The patient medical history and concomitant medications were not reported.  The patient experienced broken blood vessel in eye on 27Dec2020. The outcome of events was unknown. The reporter considered there was not a reasonable possibility that the event broken blood vessel in eye was related to the vaccine.  He was supposed to get second dose, but he did not know whether to get itor not.  Information on the lot/ batch number has been requested.; Sender's Comments: There is not a reasonable possibility that event broken blood vessel in eye is related to BNT162B2.  The event is most likely intercurrent medical condition.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Body started itching; This is a spontaneous report from a contactable consumer (patient).  A 55-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient medical history was none.  The patient's concomitant medications were not reported. On Jan2021, the patient reported that: "my body started itching but I didn't have any rash or anything like that. I am still itching some but not as much. I have been taking BENADRYL, 50 mg". The patient outcome of the event was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Rhinorrhoea
Clinical narrative: congestion and runny nose; congestion and runny nose; This is a spontaneous report from a contactable consumer (patient's wife). This consumer reported similar events for two patients (herself and her husband). This is the second of two reports. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced congestion and runny nose on an unspecified date. The clinical outcome of congestion and runny nose  was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021042569 same drug/events/reporter, different patient
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Injection site bruising
Clinical narrative: She got bruise on the injection site about the size of a half dollar; Headache; This is a spontaneous report from a contactable consumer.  An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 07Jan2021 at single dose for COVID-19 immunisation. About lot, the reporter doesn't know if it is an L or a C, 3249, and thinks it is a C. Age at vaccination was 80-years-old. Medical history included blood pressure high. Concomitant medications included lisinopril for blood pressure high plus an unspecified long list. When she got the shot, she got bruise on the injection site about the size of a half dollar. She has headache too, first two days. Onset of headache was reported as 8th or 9th day after vaccination (Jan2021). The patient is supposed to go back on the 29th. The patient was still experiencing headache, slightly but not as bad, while outcome of bruise on the injection site was unknown. Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Disease recurrence, SARS-CoV-2 test
Clinical narrative: 2nd vaccine dose administered on 08Jan, with a new increase of blood pressure; 2nd vaccine dose administered on 08Jan, with a new increase of blood pressure; This is spontaneous report from a contactable Other Healthcare Professional (patient). A 40-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Lot number: unknown, via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunisation. Medical history included Symptomatic PVC's, Tachycardia, Bradycardia, CVA (Cerebrovascular accident) in 2018, Asthma, adhesive allergy, rhythm. Concomitant medication included flecainide, metoprolol for rhythm, spironolactone. The patient previously took hydrocodone bitartrate, paracetamol (VICODIN), eletriptan and experienced drug allergy; received the first dose of BNT162B2 on 16Dec2020 03:00 PM in Left arm for COVID-19 immunisation, and experienced Hypertensive Emergency (BP 219/114) with no previous blood pressure issues, radiating chest pain, left arm pain, and jaw pain on 22Dec2020, admitted to the hospital. The patient received the 2nd vaccine dose administered on 08Jan2021, with a new increase of blood pressure. The patient underwent lab tests and procedures which included blood pressure measurement: new increase of blood pressure on an unspecified date; blood pressure 219/114 on 22Dec2020; Curative-SARS-Cov-2 Assay RT-PCR: negative on 01Jan2021. The outcome of the event was not recovered.  Information on the Lot/Batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Dyspepsia, Fatigue, Inappropriate schedule of product administration
Clinical narrative: severe heartburn; Soreness at injection site; Fatigue; Fever up to 101.8; achenes and weakness; achenes and weakness; first dose of BNT162B2 on 20Dec2020/second dose on 06Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 59-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) intramuscular at left arm on 06Jan2021 13:00 at single dose for COVID-19 immunization. Medical history included diabetes and hypertension. no allergies to medications, food, or other products.  other medications in two weeks included hydrochlorothiazide, lisinopril, atorvastatin, metformin and colecalciferol (D3) and fish oil, tocopherol (OMEGA 3 [FISH OIL;TOCOPHEROL]). the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took first dose of BNT162B2 (brand=Pfizer, Lot number: EJ1685) on 20Dec2020 04:00 PM via intramuscular at left arm at single dose for COVID-19 immunization (59 years old) and had muscle soreness at greater injection site. Patient experienced soreness at injection site, Fatigue, Fever up to 101.8, severe heartburn, achenes and weakness, all on 07Jan202101:00 AM. Prior to vaccination, the patient was not diagnosed with COVID19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the events. Patient was recovering from the events. It was non serious case. Not results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating nor congenital anomaly/birth defect.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site pain
Clinical narrative: severe heartburn; Soreness at injection site; Fatigue; Fever up to 101.8; achenes and weakness; achenes and weakness; first dose of BNT162B2 on 20Dec2020/second dose on 06Jan2021; This is a spontaneous report from a contactable other healthcare professional (HCP, patient). A 59-year-old female patient (pregnant: no) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3246) intramuscular at left arm on 06Jan2021 13:00 at single dose for COVID-19 immunization. Medical history included diabetes and hypertension. no allergies to medications, food, or other products.  other medications in two weeks included hydrochlorothiazide, lisinopril, atorvastatin, metformin and colecalciferol (D3) and fish oil, tocopherol (OMEGA 3 [FISH OIL;TOCOPHEROL]). the patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient previously took first dose of BNT162B2 (brand=Pfizer, Lot number: EJ1685) on 20Dec2020 04:00 PM via intramuscular at left arm at single dose for COVID-19 immunization (59 years old) and had muscle soreness at greater injection site. Patient experienced soreness at injection site, Fatigue, Fever up to 101.8, severe heartburn, achenes and weakness, all on 07Jan202101:00 AM. Prior to vaccination, the patient was not diagnosed with COVID19. Since the vaccination, the patient has not been tested for COVID-19. No treatment received for the events. Patient was recovering from the events. It was non serious case. Not results in death, Life threatening, caused/prolonged hospitalization, Disabling/Incapacitating nor congenital anomaly/birth defect.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: First dose was only arm soreness; This is a spontaneous report from a non-contactable consumer. A male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot and expiration date unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced arm soreness on an unspecified date. The outcome of the event was unknown.    No follow-up attempts are possible. No further information is expected. Information about Lot/Batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Neoplasm malignant
Clinical narrative: diagnosed with cancer after the first dose; patient received her first dose of Shingrix in August of 2019; This case was reported by a pharmacist via call center representative and described the occurrence of cancer in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced cancer (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the cancer and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the cancer to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient receoved 1st dose of Shingrix and some point after vaccination diagnosed with cancer. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. This case was linked with case US2020202323, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020202323:same reporter
Age: 24.0
Sex: M
Vaccine: YF
Symptoms: No adverse event, Product preparation issue
Clinical narrative: administered the YF-Vax vaccine mixed with sterile diluent water instead of sodium chloride with no adverse event; Initial information regarding an unsolicited valid non-serious case received from the other health professional.  This case involved a 24-year old male patient who experienced administered the YELLOW FEVER VACCINE - US [YF-VAX] mixed with sterile diluent water instead of sodium chloride with no adverse event (Product preparation issue).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  At the time of the event, the patient had ongoing typhoid.  On 17-Dec-2020, the patient received a dose of suspect YELLOW FEVER VACCINE - US (lot number: UJ091AA, expiry date: unknown) via an unknown route of administration in the right arm for prophylactic vaccination.  It was an actual medication error due to inappropriate reconstitution technique.  On an unknown date, it was reported that reporter noticed that there was a vial of the diluent saline from the Yellow Fever Vaccine. Reporter became aware that the sterile water was used as a diluent with the Yellow Fever instead of the normal saline and yellow fever (Product preparation issue). No adverse events were reported. No treatments were needed. Prescriptions were not written in these cases.   At the time of reporting, 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 holders 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: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: vaccine inj site reaction on 1/10 after Moderna vaccine on 1/3 Welt at injection site, hot and itchy. expanded through out the 10th started at 1-2 inches and got to about 4 inches saw an MD and has been taking benedryl.  still swollen and red and warm but has improved.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: vaccine inj site reaction on 1/10 after Moderna vaccine on 1/3 Welt at injection site, hot and itchy. expanded through out the 10th started at 1-2 inches and got to about 4 inches saw an MD and has been taking benedryl.  still swollen and red and warm but has improved.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Nausea, Pruritus
Clinical narrative: Itchy started within 3-5 minutes after injection. Started in scalp this time and then moved throughout body down to feet. After 45 minutes of it not going away, received a shot of Benadryl in left hip. Itching started to subside within 30 minutes of getting the Benadryl shot. Nauseous feelings and joint pain started about 3.5 hours after vaccine was administered.
Age: 46.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pruritus
Clinical narrative: Itchy started within 3-5 minutes after injection. Started in scalp this time and then moved throughout body down to feet. After 45 minutes of it not going away, received a shot of Benadryl in left hip. Itching started to subside within 30 minutes of getting the Benadryl shot. Nauseous feelings and joint pain started about 3.5 hours after vaccine was administered.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Fatigue, Myalgia, Neck pain
Clinical narrative: Left arm soreness, fatigue, tactile fever, muscle aches (neck/shoulders/back)
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Left arm soreness, fatigue, tactile fever, muscle aches (neck/shoulders/back)
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Hyperhidrosis, Nausea, Vomiting
Clinical narrative: Received vaccine at 10:00am. Once in observation pt complained of diaphoresis, nausea and vomited twice. She also complained of heartburn. She chose to go to the hospital in a private vehicle.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pain, Rhinorrhoea, Sneezing
Clinical narrative: Runny nose, sneezing, general malaise, achiness
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Headache, Injection site erythema, Injection site pruritus
Clinical narrative: 20 minutes after receiving the vaccine 1/11/21 I had a skin reaction on the left side of my face also felt a little dizzy. I took Benadryl for my skin and was fine after about a hour. Exactly a week later the injection site was red/hot and itchy. The next day which is 1/19/21 same thing the injection site was hot red and itchy. I also felt chest tightness, headache, nausea and dizziness. I spoke with my doctor over the phone and she prescribed me Albuterol which helped with the chest tightness. I also took Benadryl for my arm which helped. The very next night 1/20/21 the same thing happened to my arm again. It got red and itchy and I felt nauseous.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Nausea, Skin reaction
Clinical narrative: 20 minutes after receiving the vaccine 1/11/21 I had a skin reaction on the left side of my face also felt a little dizzy. I took Benadryl for my skin and was fine after about a hour. Exactly a week later the injection site was red/hot and itchy. The next day which is 1/19/21 same thing the injection site was hot red and itchy. I also felt chest tightness, headache, nausea and dizziness. I spoke with my doctor over the phone and she prescribed me Albuterol which helped with the chest tightness. I also took Benadryl for my arm which helped. The very next night 1/20/21 the same thing happened to my arm again. It got red and itchy and I felt nauseous.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: Fever (unmeasured, but after fever improved temp was still 99.4F).  Myalgias, arthralgias, headache that started over the several days prior to the fever, but the fever was the most severe reaction.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site rash, Pain, Pain in extremity
Clinical narrative: Jan 18:  noticed soreness in arm and twinges of pain when moving arm.   (Arm already compromised by rotator cuff surgery in 2012) Jan 20:  Noticed rash and redness about 4 cm in diameter at site of needle penetration.
Sex: U
Vaccine: COVID19
Symptoms: Lacrimation increased, Seborrhoea
Clinical narrative: Very oily forehead, slightly oily nose, watery left eye, a little watery right eye.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Dizziness, Headache, Myalgia
Clinical narrative: Elevated T of 100.3, body muscle/joint pain; severe headache, nausea, dizziness
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, SARS-CoV-2 test positive
Clinical narrative: Elevated T of 100.3, body muscle/joint pain; severe headache, nausea, dizziness
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Fatigue, Headache, Impaired work ability, Malaise
Clinical narrative: 0715 shot was doing gray all day Had a wine at 7pm watching tv! Then 10:30 hit me! Body and back aches headache fatigue slight nausea heart face then better feeling like poop. 11:23Took Tylenol 1 gm 81 asa and 200 mg Motrin Had taken Tylenol 1 gm at 2pm had taken Motrin 600 mg at 6 pm.  Will call in sick to work due to these symptoms :(
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: 0715 shot was doing gray all day Had a wine at 7pm watching tv! Then 10:30 hit me! Body and back aches headache fatigue slight nausea heart face then better feeling like poop. 11:23Took Tylenol 1 gm 81 asa and 200 mg Motrin Had taken Tylenol 1 gm at 2pm had taken Motrin 600 mg at 6 pm.  Will call in sick to work due to these symptoms :(
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Rash macular, Rash pruritic
Clinical narrative: Four hours after first dose, headache and fatigue. Ten hours after first dose (around 12am same day), splotchy red and slightly itchy rash on right leg, partly on left. Diminished in severity over two days' time.
Age: 11.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Family of 4 (two parents and two minors) made 4 appointments for vaccine.  Parents presented a letter re being caregivers for developmentally disabled kids as verification for registering all 4 for vaccine and were allowed to enter.  Vaccinator vaccinated parents and this child when a supervisor saw the minor and stopped the process.  However this minor received Moderna vaccine.    Parents were upset that the 2nd child was not vaccinated and upset at process that "they were told it was ok".   MD on site was informed and confirmed that no one under the age of 18 is permitted vaccine and informed family that it was not allowed.  They protested and wanted to talk to "someone who approved the letter".  It was confirmed that letter supported parental vaccination.  Nonetheless, BOTH children had been registered and one vaccinated.    Needs reporting to VAERS and I recommend risk management.  Lot # 042L20A    All registration personnel were reminded that no one under age of 18 is to be registered for vaccine, and nurse was educated.  Vaccination education will include age limitations as well going forward.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Vaccination site reaction, Vaccination site warmth
Clinical narrative: Vaccination site red, itchy, warm to touch. About 5x5in area in size. Tried taking Zyrtec and put hydrocortisone on it. Put some Hydrocortisone on it. Areas is about 5x5 cm.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: 48 hours post-injection thumb on opposite side of the injection became swollen and stiff. There was no trauma to the thumb. No other joints are swollen or stiff. The joint is more swollen, stiff and painful 1 week later (1/20/21), leading to a video visit with PCP who recommended alternating heat and ice, and continued use of NSAID as needed.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Chills, Cognitive disorder, Headache, Hyperhidrosis
Clinical narrative: Severe lethargy, extensive myalgia, arthritis, headache, drenching sweats, chills, cognitive change, fevers, severe arm pain, nausea.  Severe for 4 days. Lethargy and arm pain for total of ten days.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Severe lethargy, extensive myalgia, arthritis, headache, drenching sweats, chills, cognitive change, fevers, severe arm pain, nausea.  Severe for 4 days. Lethargy and arm pain for total of ten days.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: After vaccine next day have rash itching
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Loss of consciousness, Pain, Pyrexia
Clinical narrative: Fever of 105.0, chills, headache,  body aches and passing out.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Injection site erythema, Injection site rash, Rash erythematous, Skin warm
Clinical narrative: Late on day 7 post vaccine,  I noticed a small red rash about 3 inches below the site of injection. On day 8 the red rash doubled in size, was bright red and hot to the touch. I made an appt with urgent care and they put me on Keflex and told me to follow up with my primary.