chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Hypoaesthesia, Paraesthesia
Clinical narrative: pain in arm pit; numbness and tingling in right arm; numbness and tingling in right arm; This is a spontaneous report from a contactable other hcp.    A 32-years-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot Number: EM9810 expiry date was not reported) dose 1 via an unspecified route of administration at Arm Right on 06Feb2021 at 09:30 as a single dose for covid-19 immunisation. Medical history included polycystic ovaries (PCOS). Concomitant medication included levonorgestrel (MIRENA). The patient did not have known allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Feb2021 at 19:30, patient experienced pain in arm pit, numbness and tingling in right arm. The patient did not receive any treatment for adverse events. The outcome of the events was unknown.  Follow-up attempts completed. No further information expected.  Follow-up attempts completed. No further information expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: itchy; hives; rash on my lower body from hips to ankles.; This is a spontaneous report from a contactable consumer. This 49-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) (Lot number& Expiry date not reported) via unspecified route of administration in Left arm on 04Feb2021 9:00 (at age of 49-years-old) as single dose for COVID-19 Immunization. Patient medical history include type 2 diabetes, seasonal allergies. Patient concomitant medication includes Metformin, dulaglutide (TRULICITY), Losartan, cetirizine hydrochloride (ZYRTEC) used for unspecified indication from unknown date and unknown if ongoing. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (Lot number& Expiry date not reported) via unspecified route of administration on unspecified date as single dose for COVID-19 Immunization. On 08Feb2021 at 6:30 (4 days after vaccination), patient reported it has been 4 days since my 2nd dose of the Pfizer vaccine. This morning I woke up with itchy hives/rash on my lower body from hips to ankles. No treatment received for events. The outcome of events was not recovered.  Information on Lot/Batch number has been requested.  Follow-up (11MAY2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: head cold; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiration date and NDC number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of 2021, patient had head cold. Patient is due to get a second COVID shot on Wednesday (10Feb2021), but she had a head cold. Patient just wanted to know if she can get the second shot. The outcome of the event was unknown.  Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer. A 73-year-old male patient (husband) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/lot number: Unknown, Expiration Date: unknown), dose 1 via an unspecified route of administration on 04Jan2021 (at the age of 73-year-old) as dose 1, single for COVID-19 immunization. Medical history included prostate cancer (He is winning a battle against prostate cancer) and sensitive with food sometimes from an unknown date and unknown if ongoing. There were no concomitant medications (Other Products: No). He was winning a battle against prostate cancer. He had been doing well. Reporter stated, on Saturday he ate a piece of fish. He was sensitive with food sometimes. If there were bacteria, he gets a nausea feeling and he had to dry heave sort of. Well, he had to do that a little bit on Saturday when he ate this fish. He had paused and then kept eating. So, reporter was wondering if this onset was from that. It would have been 48 hours after. It could be possible. He had the dry heaving for about 3-4 mins. Then he kept eating. Normally that feeling was acute and will not eat. But he did not feel it again. On 04Jan2021, patient experienced exhaustion. Reporter stated, after his first dose he was exhausted for about a day. He did not get the vaccine in his providers office, he got it from the staff where they were giving the vaccine. The hospital was giving them. He only experienced the exhaustion for one day and recovered completely. No treatment received for the event. There was no investigation assessment. The outcome of event was recovered on 05Jan2021.  Information on the lot/batch number has been requested.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Right below his waist and that was a rash was reported as worsened; This is a spontaneous report from a contactable consumer (patients wife). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection; Batch/Lot number: unknown), dose 1 via an unspecified route of administration on 01Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. For Lot number, reporter stated that she didn't see a number like that, it was a number, she got the card and it said the date when he was supposed to get his second shot but she didn't see any number. Reporter (wife) stated, patient had the vaccine for COVID 19 on Feb 1st. And everything was fine until Friday when he took a shower, he noticed something on the back, right below his waist and that was a rash. And it was kind of not little, tiny dots but a big red, it kind of looks like applicator skin only that it was red. And it was wrapped around into the, around the thigh and up and around his leg. And it just got worst now, from Saturday, and Sunday. But it does not itch, it doesn't bothers breathing. And she was tried to get help at the clinic and no body returns the call. So, she was of lost right now. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever and chills; This is a spontaneous report from a contactable consumer or other non hcp.   A 70-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 26Jan2021 (Batch/Lot Number: E19262) as 2ND DOSE, SINGLE for covid-19 immunization. The patient medical history and concomitant medication was not reported. On 06Feb2021, After the second dose the patient experienced fever of almost 104 degrees and chills, they do not know the reason for it. He did not feel sick before. He had not been in contact with anyone with COVID. The fever, to be exact, was 103.5 all night. It broke early the next morning after taking Tylenol. He has not had it since then. they both went to get tested for COVID. They both had a rapid COVID test, and they were both negative. Their daughter was saying that maybe he had a delayed reaction to the vaccine. The patient experienced fever and chills on 06Feb2021 with outcome of recovered.  The patient lab tests included body temperature: 103.5(Almost 104 degrees/The fever, to be exact, was 103.5 all night) on 06Feb2021 and Sars-cov-2 test: negative on 08Feb2021. The event outcome is recovered on 07Feb2021.  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: Fever; Joint pain; Muscle pain; Chills; This is a spontaneous report from a contactable consumer. A 72-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EL9261), via an unspecified route of administration, administered in arm on an unspecified date as dose number unknown, single for covid-19 immunisation. Medical history none and concomitant medications were not reported.  On an unspecified date, she was calling about the shot Saturday morning 10 am. She confirmed it was the Pfizer COVID 19 vaccine. She stated that she doesn't have any other reason to all. She had some joint pain, fever and muscle pain and she got at 10 o'clock Saturday (on an unkown date) and she also has chills. She asked is that normal are they going to tell normal how do she is woman not many patients. She does not know how much they gave she only knows that they stuck her in the arm. She said that nothing else to add. There was nothing until today. She confirmed she means that the symptoms started today. Outcome of the event was unknown.    Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Conjunctivitis, Diarrhoea, Dry eye
Clinical narrative: Stomach cramping and spasming below naval; Diarrhea all day; vomiting bile x3 in morning; Chills but no fever; headache; very sore body; I woke up feeling like I had pinkeye; No crust but a little redness; Eyes felt dry and tired by the end of the day.; Day 1 - No problem. Arm got sore.; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6201 and Expiration date not reported), (at the age of 56-Year-old) via an unspecified route of administration on 13Feb2021 at 14:30 on left arm as single dose for COVID-19 immunisation. The patient's medical history was not reported. He was allergic to dust, grass, english plantain and iodine dye. Concomitant medications were Losartan potassium 25 mg and Rosuvastatin calcium 10 mg. No other vaccine received in four weeks. On 15Feb2021 at 07:00, the patient experienced "Day 1 - No problem. Arm got sore". On 16Feb2021, he noticed eyes felt dry and tired by the end of the day and arm still very sore. On 17Feb2021, he woke up feeling like he had pinkeye and no crust but a little redness. It annoyed him all day. On 18Feb2021, he had lubricating eye drops so that helped. Stay developed on lower left lid. He used the drops in the morning. Otherwise, ok. On 20Feb2021, He informed that eyes still dry. Stomach cramping and spasming below naval. Diarrhea all day and vomiting bile x3 in morning. Chills but no fever. Headache and very sore body. Slept on and off all day. On 21Feb2021, he started with diarrhea x3 at 4am. Slept until 10:30. More diarrhea x3. Still fatigued but feeling better. Took Imodium to slow things down. Lost 4 pounds. He was thinking he would be 100% by Sunday. Not looking forward to second shot. The patient treated himself for adverse event. The patient tested COVID neither prior vaccination nor post vaccination. The outcome of the events was not recovered.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Headache, Pain, Pain in extremity, Vomiting
Clinical narrative: Stomach cramping and spasming below naval; Diarrhea all day; vomiting bile x3 in morning; Chills but no fever; headache; very sore body; I woke up feeling like I had pinkeye; No crust but a little redness; Eyes felt dry and tired by the end of the day.; Day 1 - No problem. Arm got sore.; This is a spontaneous report from a contactable consumer (patient, self-reporting). A 56-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6201 and Expiration date not reported), (at the age of 56-Year-old) via an unspecified route of administration on 13Feb2021 at 14:30 on left arm as single dose for COVID-19 immunisation. The patient's medical history was not reported. He was allergic to dust, grass, english plantain and iodine dye. Concomitant medications were Losartan potassium 25 mg and Rosuvastatin calcium 10 mg. No other vaccine received in four weeks. On 15Feb2021 at 07:00, the patient experienced "Day 1 - No problem. Arm got sore". On 16Feb2021, he noticed eyes felt dry and tired by the end of the day and arm still very sore. On 17Feb2021, he woke up feeling like he had pinkeye and no crust but a little redness. It annoyed him all day. On 18Feb2021, he had lubricating eye drops so that helped. Stay developed on lower left lid. He used the drops in the morning. Otherwise, ok. On 20Feb2021, He informed that eyes still dry. Stomach cramping and spasming below naval. Diarrhea all day and vomiting bile x3 in morning. Chills but no fever. Headache and very sore body. Slept on and off all day. On 21Feb2021, he started with diarrhea x3 at 4am. Slept until 10:30. More diarrhea x3. Still fatigued but feeling better. Took Imodium to slow things down. Lost 4 pounds. He was thinking he would be 100% by Sunday. Not looking forward to second shot. The patient treated himself for adverse event. The patient tested COVID neither prior vaccination nor post vaccination. The outcome of the events was not recovered.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Prolonged Nausea; vomiting; diarrhea; This is a spontaneous report from a contactable nurse (the patient, reported for self). This 39-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, Lot number: EL8982 & Expiration date: Not reported), via an unspecified route of administration in Left arm on 28Jan2021 at 8:00 (at age of 39-years-old) as single dose for COVID-19 immunization. Patient medical history includes Ulcerative colitis, Latent TB infection both from an unspecified date and unknown if ongoing. Patient concomitant medications include adalimumab (HUMIRA), Isoniazid, vitamin b6, iron, multivitamins used for used for unspecified indication from unknown date and unknown ongoing. Patient did not have any known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 02Feb2021 (5ays after vaccination), Patient experienced prolonged nausea, vomiting, diarrhea starting on day 5 after receipt of vaccine and continuing until present. Treatment received for events with Zofran given for prolonged nausea and vomiting. Post vaccination, the patient was not tested for COVID. The outcome of events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Agitation, Arthralgia, Ear pain, Fatigue, Lymph node pain
Clinical narrative: Hyper feeling for an hour or 2; Sore throat; Muscle sore this morning; Lymph node, it was sore; I think no matter what you say I think I am going to go get the culture because I think it is strep I had it before although now I have not had strep in 10- 15 years; When I swallow it hurts; Tired; I had one joint that hurt; ear was sore on the left side; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) dose 1 via an unspecified route of administration on 08Feb2021 as dose 1, single for covid-19 immunization. The patient medical history was strep. The patient's concomitant medications were not reported. On Feb2021, the patient stated that, I had my Covid vaccine on Monday and you know I had couple minor side effects, tired, I had one joint that hurt you know, I have other people say that (Not further clarified hence split case was not made) and kind of a hyper feeling for an hour or two, different symptoms come and go, I went and I felt pretty good, I just felt wonderful, up until last night, at 11 O'clock last night when was thinking I was going to bed then I started to have a sore throat and I can see on one side back of my sore throat it looks goofy, that's the only place in the back of my throat that hurts it's that one area and it looks like 3 bumps and I called my clinic because I said well I think it was strep, I should come for culture because I had the Covid vaccine protocol was for a person to first call you guys before you go in  urgent care to report if this could be a side effect, I still think it was strep myself because of the fact that I got the shot on Monday 08Feb2021 and on Thursday 11Feb2021 I was tired. Lymph node, it was sore, not in the joint but like muscle sore this morning, that was letting up as I am moving around and everything, but defiantly I can't, you know it hurts almost when I don't swallow, but when I swallow it hurts and I can see it there in one area, but a size of a nickel probably that's goofy, that gland was sore and that ear was sore on the left side, now I think no matter what you say I think I am going to go get the culture because I think it was strep I had it before although now I have not had strep in 10- 15 years. So why I got this I don't know because I stay isolated because from everybody so I don't know how I could have gotten that, so what do you think. Consumer stated, in other words, are you going to tell me, or should I just go get the throat culture, so what was the number you were giving me. Consumer stated, so the problem was I don't know if this was vaccine related, this was probably strep, should not I go and find out if it was strep and if they say, I don't know I just, forget it. The outcome of all events as an unknown.
Sex: U
Vaccine: COVID19
Symptoms: Myalgia, Odynophagia, Oropharyngeal pain, Streptococcal infection
Clinical narrative: Hyper feeling for an hour or 2; Sore throat; Muscle sore this morning; Lymph node, it was sore; I think no matter what you say I think I am going to go get the culture because I think it is strep I had it before although now I have not had strep in 10- 15 years; When I swallow it hurts; Tired; I had one joint that hurt; ear was sore on the left side; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6201; Expiration Date: 30Jun2021) dose 1 via an unspecified route of administration on 08Feb2021 as dose 1, single for covid-19 immunization. The patient medical history was strep. The patient's concomitant medications were not reported. On Feb2021, the patient stated that, I had my Covid vaccine on Monday and you know I had couple minor side effects, tired, I had one joint that hurt you know, I have other people say that (Not further clarified hence split case was not made) and kind of a hyper feeling for an hour or two, different symptoms come and go, I went and I felt pretty good, I just felt wonderful, up until last night, at 11 O'clock last night when was thinking I was going to bed then I started to have a sore throat and I can see on one side back of my sore throat it looks goofy, that's the only place in the back of my throat that hurts it's that one area and it looks like 3 bumps and I called my clinic because I said well I think it was strep, I should come for culture because I had the Covid vaccine protocol was for a person to first call you guys before you go in  urgent care to report if this could be a side effect, I still think it was strep myself because of the fact that I got the shot on Monday 08Feb2021 and on Thursday 11Feb2021 I was tired. Lymph node, it was sore, not in the joint but like muscle sore this morning, that was letting up as I am moving around and everything, but defiantly I can't, you know it hurts almost when I don't swallow, but when I swallow it hurts and I can see it there in one area, but a size of a nickel probably that's goofy, that gland was sore and that ear was sore on the left side, now I think no matter what you say I think I am going to go get the culture because I think it was strep I had it before although now I have not had strep in 10- 15 years. So why I got this I don't know because I stay isolated because from everybody so I don't know how I could have gotten that, so what do you think. Consumer stated, in other words, are you going to tell me, or should I just go get the throat culture, so what was the number you were giving me. Consumer stated, so the problem was I don't know if this was vaccine related, this was probably strep, should not I go and find out if it was strep and if they say, I don't know I just, forget it. The outcome of all events as an unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Blood prolactin, Body temperature, Breast pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection, Batch/Lot Number: EL3249), via intramuscular route of administration, administered in Arm Left on 28Jan2021 13:30 as 2ND DOSE SINGLE for covid-19 immunisation. Patient didn't received other vaccination with in 4weeks prior to vaccination patient didn't had any illness at the time of vaccination. Medical history reported as gastritis from an unknown date and unknown if ongoing Gastritis, constipation from an unknown date and unknown if ongoing IBS with Constipation, irritable bowel syndrome from an unknown date and unknown if ongoing, abdominal discomfort from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole (PANTOPRAZOLE) taken for abdominal discomfort from an unspecified start date and ongoing; citalopram (CITALOPRAM) taken for abdominal discomfort from an unspecified start date and ongoing; clonazepam (CLONAZEPAM) taken for anxiety from an unspecified start date and ongoing. The patient underwent lab tests and procedures which included blood pressure measurement low on 11Feb2021, blood prolactin 62.1 ng/ml on 27Jan2021, body temperature 103 on spiked to 101 on 28Jan2021, then went up to about 103 for the next few days. States that it has improved but has levelled out to be a constant 100-100.5. This morning her temperature was 100.9, body temperature: 101 on 28Jan2021 spiked to 101 on 28Jan2021, then went up to about 103 for the next few days. States that it has improved but has levelled out to be a constant 100-100.5. This morning her temperature was 100.9, chest x-ray: normal on 11Feb2021, electrocardiogram normal on 11Feb2021, sars-cov-2 test: negative on 11Feb2021, sars-cov-2 test: negative on 17Feb2021, scan brain: unknown results on unspecified date. The patient experienced low grade fever on 28Jan2021, headache on 29Jan2021, sweats on 29Jan2021, chills on 29Jan2021, diarrhoea on an unspecified date, body aches on 29Jan2021, breast lactation on Jan2021, low blood pressure on 11Feb2021, breast pain on Jan 2021, dizziness on 11Feb2021, joint pain on 29Jan2021 patient was required to visit the emergency room for the events dizziness and hypotension. Therapeutic measures were taken as a result of, body aches (pain), low blood pressure (hypotension), joint pain (arthralgia). The outcome of the events hyperhidrosis, chills was unknown pyrexia, headache, Arthralgia,pain was recovering, diarrhoea, galactorrhoea,breast pain was not recovered, dizziness and hypotension was recovered on 11 Feb 2021. Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chest X-ray, Chills, Diarrhoea, Dizziness, Electrocardiogram
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection, Batch/Lot Number: EL3249), via intramuscular route of administration, administered in Arm Left on 28Jan2021 13:30 as 2ND DOSE SINGLE for covid-19 immunisation. Patient didn't received other vaccination with in 4weeks prior to vaccination patient didn't had any illness at the time of vaccination. Medical history reported as gastritis from an unknown date and unknown if ongoing Gastritis, constipation from an unknown date and unknown if ongoing IBS with Constipation, irritable bowel syndrome from an unknown date and unknown if ongoing, abdominal discomfort from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole (PANTOPRAZOLE) taken for abdominal discomfort from an unspecified start date and ongoing; citalopram (CITALOPRAM) taken for abdominal discomfort from an unspecified start date and ongoing; clonazepam (CLONAZEPAM) taken for anxiety from an unspecified start date and ongoing. The patient underwent lab tests and procedures which included blood pressure measurement low on 11Feb2021, blood prolactin 62.1 ng/ml on 27Jan2021, body temperature 103 on spiked to 101 on 28Jan2021, then went up to about 103 for the next few days. States that it has improved but has levelled out to be a constant 100-100.5. This morning her temperature was 100.9, body temperature: 101 on 28Jan2021 spiked to 101 on 28Jan2021, then went up to about 103 for the next few days. States that it has improved but has levelled out to be a constant 100-100.5. This morning her temperature was 100.9, chest x-ray: normal on 11Feb2021, electrocardiogram normal on 11Feb2021, sars-cov-2 test: negative on 11Feb2021, sars-cov-2 test: negative on 17Feb2021, scan brain: unknown results on unspecified date. The patient experienced low grade fever on 28Jan2021, headache on 29Jan2021, sweats on 29Jan2021, chills on 29Jan2021, diarrhoea on an unspecified date, body aches on 29Jan2021, breast lactation on Jan2021, low blood pressure on 11Feb2021, breast pain on Jan 2021, dizziness on 11Feb2021, joint pain on 29Jan2021 patient was required to visit the emergency room for the events dizziness and hypotension. Therapeutic measures were taken as a result of, body aches (pain), low blood pressure (hypotension), joint pain (arthralgia). The outcome of the events hyperhidrosis, chills was unknown pyrexia, headache, Arthralgia,pain was recovering, diarrhoea, galactorrhoea,breast pain was not recovered, dizziness and hypotension was recovered on 11 Feb 2021. Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Galactorrhoea, Headache, Hyperhidrosis, Hypotension, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection, Batch/Lot Number: EL3249), via intramuscular route of administration, administered in Arm Left on 28Jan2021 13:30 as 2ND DOSE SINGLE for covid-19 immunisation. Patient didn't received other vaccination with in 4weeks prior to vaccination patient didn't had any illness at the time of vaccination. Medical history reported as gastritis from an unknown date and unknown if ongoing Gastritis, constipation from an unknown date and unknown if ongoing IBS with Constipation, irritable bowel syndrome from an unknown date and unknown if ongoing, abdominal discomfort from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole (PANTOPRAZOLE) taken for abdominal discomfort from an unspecified start date and ongoing; citalopram (CITALOPRAM) taken for abdominal discomfort from an unspecified start date and ongoing; clonazepam (CLONAZEPAM) taken for anxiety from an unspecified start date and ongoing. The patient underwent lab tests and procedures which included blood pressure measurement low on 11Feb2021, blood prolactin 62.1 ng/ml on 27Jan2021, body temperature 103 on spiked to 101 on 28Jan2021, then went up to about 103 for the next few days. States that it has improved but has levelled out to be a constant 100-100.5. This morning her temperature was 100.9, body temperature: 101 on 28Jan2021 spiked to 101 on 28Jan2021, then went up to about 103 for the next few days. States that it has improved but has levelled out to be a constant 100-100.5. This morning her temperature was 100.9, chest x-ray: normal on 11Feb2021, electrocardiogram normal on 11Feb2021, sars-cov-2 test: negative on 11Feb2021, sars-cov-2 test: negative on 17Feb2021, scan brain: unknown results on unspecified date. The patient experienced low grade fever on 28Jan2021, headache on 29Jan2021, sweats on 29Jan2021, chills on 29Jan2021, diarrhoea on an unspecified date, body aches on 29Jan2021, breast lactation on Jan2021, low blood pressure on 11Feb2021, breast pain on Jan 2021, dizziness on 11Feb2021, joint pain on 29Jan2021 patient was required to visit the emergency room for the events dizziness and hypotension. Therapeutic measures were taken as a result of, body aches (pain), low blood pressure (hypotension), joint pain (arthralgia). The outcome of the events hyperhidrosis, chills was unknown pyrexia, headache, Arthralgia,pain was recovering, diarrhoea, galactorrhoea,breast pain was not recovered, dizziness and hypotension was recovered on 11 Feb 2021. Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Scan brain
Clinical narrative: This is a spontaneous report from a contactable consumer or other non hcp. A 44-years-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Solution for injection, Batch/Lot Number: EL3249), via intramuscular route of administration, administered in Arm Left on 28Jan2021 13:30 as 2ND DOSE SINGLE for covid-19 immunisation. Patient didn't received other vaccination with in 4weeks prior to vaccination patient didn't had any illness at the time of vaccination. Medical history reported as gastritis from an unknown date and unknown if ongoing Gastritis, constipation from an unknown date and unknown if ongoing IBS with Constipation, irritable bowel syndrome from an unknown date and unknown if ongoing, abdominal discomfort from an unknown date and unknown if ongoing, anxiety from an unknown date and unknown if ongoing. Concomitant medications included pantoprazole (PANTOPRAZOLE) taken for abdominal discomfort from an unspecified start date and ongoing; citalopram (CITALOPRAM) taken for abdominal discomfort from an unspecified start date and ongoing; clonazepam (CLONAZEPAM) taken for anxiety from an unspecified start date and ongoing. The patient underwent lab tests and procedures which included blood pressure measurement low on 11Feb2021, blood prolactin 62.1 ng/ml on 27Jan2021, body temperature 103 on spiked to 101 on 28Jan2021, then went up to about 103 for the next few days. States that it has improved but has levelled out to be a constant 100-100.5. This morning her temperature was 100.9, body temperature: 101 on 28Jan2021 spiked to 101 on 28Jan2021, then went up to about 103 for the next few days. States that it has improved but has levelled out to be a constant 100-100.5. This morning her temperature was 100.9, chest x-ray: normal on 11Feb2021, electrocardiogram normal on 11Feb2021, sars-cov-2 test: negative on 11Feb2021, sars-cov-2 test: negative on 17Feb2021, scan brain: unknown results on unspecified date. The patient experienced low grade fever on 28Jan2021, headache on 29Jan2021, sweats on 29Jan2021, chills on 29Jan2021, diarrhoea on an unspecified date, body aches on 29Jan2021, breast lactation on Jan2021, low blood pressure on 11Feb2021, breast pain on Jan 2021, dizziness on 11Feb2021, joint pain on 29Jan2021 patient was required to visit the emergency room for the events dizziness and hypotension. Therapeutic measures were taken as a result of, body aches (pain), low blood pressure (hypotension), joint pain (arthralgia). The outcome of the events hyperhidrosis, chills was unknown pyrexia, headache, Arthralgia,pain was recovering, diarrhoea, galactorrhoea,breast pain was not recovered, dizziness and hypotension was recovered on 11 Feb 2021. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis contact
Clinical narrative: a potential reaction to surgical adhesive; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 02Feb2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date of 2021, after the first dose, patient had gall bladder surgery and had a potential reaction to the oxycodone and surgical adhesive. Patient asked that if it was okay to take the vaccine, as she was scheduled to receive the second dose tomorrow (24Feb2021). The outcome of the event was unknown.  Information on lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.   No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Chills, Diarrhoea, Eye swelling
Clinical narrative: Rash to face and left arm; swollen lymph node to right arm; febrile and flushed; febrile and flushed; sweats and chills; sweats and chills; nausea; vomiting; diarrhea; muscle and joint pain; muscle and joint pain; severe headache; generalized weakness; swollen eyes; insomnia; This is a spontaneous report from a non-contactable other hcp (Nurse). A 31-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via intramuscular, administered in arm right on 07Jan2021 14:15 (age of vaccination: 31-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient previously received first dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient tested covid post vaccination. The patient has non known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), naproxen (NAPROXEN) and paracetamol (TYLENOL). The patient experienced rash to face and left arm, swollen lymph node to right arm, febrile and flushed, sweats and chills, nausea vomiting diarrhea, muscle and joint pain, severe headache, generalized weakness, swollen eyes, insomnia on 07Jan2021 at 07:00 PM. Treatment received otc medications, prednisone rescue regimen and muscle relaxants. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Jan2021. The outcome of all the events was recovered with lasting effects on unspecified date.  No follow-up attempts are possible. Information on batch/lot number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Hyperhidrosis, Insomnia, Lymphadenopathy
Clinical narrative: Rash to face and left arm; swollen lymph node to right arm; febrile and flushed; febrile and flushed; sweats and chills; sweats and chills; nausea; vomiting; diarrhea; muscle and joint pain; muscle and joint pain; severe headache; generalized weakness; swollen eyes; insomnia; This is a spontaneous report from a non-contactable other hcp (Nurse). A 31-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via intramuscular, administered in arm right on 07Jan2021 14:15 (age of vaccination: 31-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient previously received first dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient tested covid post vaccination. The patient has non known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), naproxen (NAPROXEN) and paracetamol (TYLENOL). The patient experienced rash to face and left arm, swollen lymph node to right arm, febrile and flushed, sweats and chills, nausea vomiting diarrhea, muscle and joint pain, severe headache, generalized weakness, swollen eyes, insomnia on 07Jan2021 at 07:00 PM. Treatment received otc medications, prednisone rescue regimen and muscle relaxants. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Jan2021. The outcome of all the events was recovered with lasting effects on unspecified date.  No follow-up attempts are possible. Information on batch/lot number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia, Rash, SARS-CoV-2 test
Clinical narrative: Rash to face and left arm; swollen lymph node to right arm; febrile and flushed; febrile and flushed; sweats and chills; sweats and chills; nausea; vomiting; diarrhea; muscle and joint pain; muscle and joint pain; severe headache; generalized weakness; swollen eyes; insomnia; This is a spontaneous report from a non-contactable other hcp (Nurse). A 31-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via intramuscular, administered in arm right on 07Jan2021 14:15 (age of vaccination: 31-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient previously received first dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient tested covid post vaccination. The patient has non known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), naproxen (NAPROXEN) and paracetamol (TYLENOL). The patient experienced rash to face and left arm, swollen lymph node to right arm, febrile and flushed, sweats and chills, nausea vomiting diarrhea, muscle and joint pain, severe headache, generalized weakness, swollen eyes, insomnia on 07Jan2021 at 07:00 PM. Treatment received otc medications, prednisone rescue regimen and muscle relaxants. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Jan2021. The outcome of all the events was recovered with lasting effects on unspecified date.  No follow-up attempts are possible. Information on batch/lot number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Rash to face and left arm; swollen lymph node to right arm; febrile and flushed; febrile and flushed; sweats and chills; sweats and chills; nausea; vomiting; diarrhea; muscle and joint pain; muscle and joint pain; severe headache; generalized weakness; swollen eyes; insomnia; This is a spontaneous report from a non-contactable other hcp (Nurse). A 31-years-old non pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiry date was not reported) via intramuscular, administered in arm right on 07Jan2021 14:15 (age of vaccination: 31-years-old) as dose 2, single for COVID-19 immunization. The patient medical history was not reported. The patient previously received first dose for COVID-19 immunization. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient tested covid post vaccination. The patient has non known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included diphenhydramine hydrochloride (BENADRYL), naproxen (NAPROXEN) and paracetamol (TYLENOL). The patient experienced rash to face and left arm, swollen lymph node to right arm, febrile and flushed, sweats and chills, nausea vomiting diarrhea, muscle and joint pain, severe headache, generalized weakness, swollen eyes, insomnia on 07Jan2021 at 07:00 PM. Treatment received otc medications, prednisone rescue regimen and muscle relaxants. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 13Jan2021. The outcome of all the events was recovered with lasting effects on unspecified date.  No follow-up attempts are possible. Information on batch/lot number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Fatigue, Headache, Pain in extremity
Clinical narrative: metalic taste; throat tightened up; tachycardia 130-140 x 20 min; dizzyness; fatigue; headache; sore arm; This is a spontaneous report from a contactable consumer(patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID 19 Vaccine, Solution for injection, Lot number: EL1283, Expiration date: Not reported), intramuscular administered in arm right on 07Jan2021 12:00 (at a age of 57-year-old) as dose 2 single and recevied BNT162B2 (PFIZER-BIONTECH COVID 19 VaccineLot number: EH9899, Expiration date: Not reported) intramuscular administered in arm right on 07Dec2020 19:00 as dose 1 singel, for COVID-19 immunisation. Patient previously took the medication included were Loratab, Losartan, Amlodipine. Once received loratab patient become itchy, feels like bugs crawling all over. No significant relevant family history, No there predisposing factors, no was a culture performed. Concomitant medication included paracetamol (TYLENOL, Strength: 160 mg) at 160 mg taken from 07Jan2021 11:00; diphenhydramine hydrochloride (BENADRYL, Strength: 50mg) at 50mg from 07Jan2021 11:00. It was reported that the on 07Jan2021 at 12.00 patient experienced metallic taste, throat tightened up, tachycardia (130-140 within 20 min), dizziness, fatigue. Epipen was available at the time of 2nd injection did not need it. This all happened with in 1st 1 min of receiving the vaccine. No nausea or loose stools did have headache and sore arm lasted 2 days. No treatment needed. The events were considered as non serious. The outcome of the events were recovered, headache and sore arm were recovered on 09Jan2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia, Throat tightness
Clinical narrative: metalic taste; throat tightened up; tachycardia 130-140 x 20 min; dizzyness; fatigue; headache; sore arm; This is a spontaneous report from a contactable consumer(patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID 19 Vaccine, Solution for injection, Lot number: EL1283, Expiration date: Not reported), intramuscular administered in arm right on 07Jan2021 12:00 (at a age of 57-year-old) as dose 2 single and recevied BNT162B2 (PFIZER-BIONTECH COVID 19 VaccineLot number: EH9899, Expiration date: Not reported) intramuscular administered in arm right on 07Dec2020 19:00 as dose 1 singel, for COVID-19 immunisation. Patient previously took the medication included were Loratab, Losartan, Amlodipine. Once received loratab patient become itchy, feels like bugs crawling all over. No significant relevant family history, No there predisposing factors, no was a culture performed. Concomitant medication included paracetamol (TYLENOL, Strength: 160 mg) at 160 mg taken from 07Jan2021 11:00; diphenhydramine hydrochloride (BENADRYL, Strength: 50mg) at 50mg from 07Jan2021 11:00. It was reported that the on 07Jan2021 at 12.00 patient experienced metallic taste, throat tightened up, tachycardia (130-140 within 20 min), dizziness, fatigue. Epipen was available at the time of 2nd injection did not need it. This all happened with in 1st 1 min of receiving the vaccine. No nausea or loose stools did have headache and sore arm lasted 2 days. No treatment needed. The events were considered as non serious. The outcome of the events were recovered, headache and sore arm were recovered on 09Jan2021.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Oxygen saturation, Oxygen saturation decreased, Pyrexia
Clinical narrative: oxygen levels went down; fever; chills; This is a spontaneous report from a contactable consumer or other non hcp. A 35-years-old male patient received bnt162b2 (BNT162B2, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Right on 03Feb2021 (35-years-old at the time of vaccination) (Batch/Lot Number: EL9264) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included gout, Sjogren's syndrome from an unknown date and unknown if ongoing, covid-19 from Mar2020 to an unknown date (when I had COVID in Mar2020), coma (This is what initially sent me to the hospital for COVID which ended up with 22 days in a coma and on a ventilator) from an unknown date and unknown if ongoing. The patient previously took quinolones and experienced drug hypersensitivity. Patient was allergic to Barley. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Historical vaccine included (BNT162B2, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on13Jan2021 09:45 AM (Batch/Lot Number: EL8982) as DOSE 1, SINGLE for covid-19 immunisation. Concomitant medication included allopurinol, apixaban (ELIQUIS), fluoxetine hydrochloride (FLUOXET), clonazepam (KLONOPIN), gabapentin (NEURONTIN) taken for an unspecified indication, start and stop date were not reported. Patient stated that on 03Feb2021 06:00 PM, A few hours after his second injection, he started to have the same symptoms as when he had COVID in Mar2020. His oxygen levels went down (to 91) and he had fever and chills. This was what initially sent him to the hospital for COVID which ended up with 22 days in a coma and on a ventilator (2020). The patient underwent lab tests and procedures which included oxygen saturation: 91 on 03Feb2021 oxygen levels went down (to 91). Patient did not receive any treatment. The seriousness of the reported event oxygen levels went down was assessed as serious medically significant. The clinical outcome of the events was recovered in 2021.  No follow-up attempts are needed. No further information is expected.