chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Insomnia, Pain, Palpitations
Clinical narrative: Chills; Fever; Heart racing; ached from head to toe/body soreness; FLU LIKE FEELING; Could not sleep and mind was racing; her mind was racing; Soreness at the injection site; Tension headache with pressure; This is a spontaneous report from a contactable consumer reported for herself. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on left arm on 20Jan2021 12:30 at SINGLE DOSE for covid-19 immunisation. Medical history included none.  There were no concomitant medications. The patient received the vaccine on Wednesday, 20Jan2021. This was her first dose. She had the vaccine at 12:30 PM. Right after the vaccine she waited her 15-20 minutes and was fine. These things did not start till later. She was not sick prior to getting the vaccine. 8 hours after, around 8:30 PM she had a tension headache with pressure that went all through the night and let up around 21Jan2021 10 AM. Around 12 AM Thursday morning on 21Jan2021, she had chills, fever, and a racing heart. She ached from head to toe/body soreness. It was a flu like feeling. Then they all got better around the same time 21Jan2021 evening. The racing heart was not enough to need 911. It worried her but was not enough. She also could not sleep and her mind was racing. She thinks it was because what was going on with her racing heart. It was making her head pound. She finally was able to sleep last night on 21Jan2021 around 8:30 PM and slept until 4:30 AM this morning on 22Jan2021. The doctors said if she was not better by tomorrow they would work her in to see her. But she is much better today. She also had soreness at the injection site on 20Jan2021. She knew that was normal though. She is still sore but overall is better. It felt like there was an invasion in her body. She is a little scared now for the second dose. She is unsure if she wants to get it. She asks, do you recommend getting the second dose after she had all of these side effects? It worries her. The heart is the main thing. That worried her the most. Outcome of the event tension headache with pressure, chills, fever, heart racing, ached from head to toe/body soreness, flu like feeling was recovered on 21Jan2021, outcome of the event could not sleep and mind was racing was recovered on 22Jan2021, outcome of the event soreness at the injection site was not recovered.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachyphrenia, Tension headache, Vaccination site pain
Clinical narrative: Chills; Fever; Heart racing; ached from head to toe/body soreness; FLU LIKE FEELING; Could not sleep and mind was racing; her mind was racing; Soreness at the injection site; Tension headache with pressure; This is a spontaneous report from a contactable consumer reported for herself. A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on left arm on 20Jan2021 12:30 at SINGLE DOSE for covid-19 immunisation. Medical history included none.  There were no concomitant medications. The patient received the vaccine on Wednesday, 20Jan2021. This was her first dose. She had the vaccine at 12:30 PM. Right after the vaccine she waited her 15-20 minutes and was fine. These things did not start till later. She was not sick prior to getting the vaccine. 8 hours after, around 8:30 PM she had a tension headache with pressure that went all through the night and let up around 21Jan2021 10 AM. Around 12 AM Thursday morning on 21Jan2021, she had chills, fever, and a racing heart. She ached from head to toe/body soreness. It was a flu like feeling. Then they all got better around the same time 21Jan2021 evening. The racing heart was not enough to need 911. It worried her but was not enough. She also could not sleep and her mind was racing. She thinks it was because what was going on with her racing heart. It was making her head pound. She finally was able to sleep last night on 21Jan2021 around 8:30 PM and slept until 4:30 AM this morning on 22Jan2021. The doctors said if she was not better by tomorrow they would work her in to see her. But she is much better today. She also had soreness at the injection site on 20Jan2021. She knew that was normal though. She is still sore but overall is better. It felt like there was an invasion in her body. She is a little scared now for the second dose. She is unsure if she wants to get it. She asks, do you recommend getting the second dose after she had all of these side effects? It worries her. The heart is the main thing. That worried her the most. Outcome of the event tension headache with pressure, chills, fever, heart racing, ached from head to toe/body soreness, flu like feeling was recovered on 21Jan2021, outcome of the event could not sleep and mind was racing was recovered on 22Jan2021, outcome of the event soreness at the injection site was not recovered.
Sex: M
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: stated that her husband has asthma, less well controlled; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 17Jan2021 at single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient has asthma, less well controlled on an unspecified date with outcome of unknown. It stated that he was fine.  Information on the Batch/Lot number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Vertigo; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received second dose bnt162b2, via an unspecified route of administration on 21Jan2021 11:00 at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced vertigo on an unspecified date. Caller stated that she had the second dose of Covid booster yesterday at 11:00. Stated that at 2 AM she woke up with vertigo that she never had before. Wanted to know what she can take for it. Stated that she works at the hospital. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Malaise, Nausea
Clinical narrative: Feeling unwell and lousy; Feeling warm; Nausea; This is a spontaneous report from a contactable consumer (patient). A 31-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686), intramuscular at left arm on 21Jan2021 at 12:30 single dose for COVID-19 immunization. The patient medical history included asthma (diagnosed 11 years ago, family history of asthma on mother's side) and pain, both from an unknown date and unknown if ongoing. The patient's concomitant medication included methadone at 75 mg once a day for pain. On 21Jan2021, the patient experienced nausea at 19:00, feeling unwell and lousy and feeling warm at 21:00. The patient's outcome of the events was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, visual
Clinical narrative: Visual hallucinations /I began to hallucinate colors on phone; This is a spontaneous report from a non-contactable consumer.  A 22-year-old female consumer reported that she received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number EN5318), at single dose on an unknown date for COVID-19 immunization. Medical history and concomitant drugs were unknown. The patient reported that immediately after receiving the vaccine she went on her phone in the area where patients had to be held for 15 minutes to be monitored for severe reactions.    She began to hallucinate colors on her Smartphone that she knew don't belong. She was seeing purple and light blue outlines around the (messaging app name) bubbles and they looked real. This lasted for about 30 minutes.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Severe case of diarrhea; This is a spontaneous report from a contactable consumer(reporter's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient had the shot one week ago and he has severe case of diarrhea today a week later on Jan2021. Outcome of event was unknown.    Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: they tested another one and it was positive; they tested another one and it was positive; This is a spontaneous report from a contactable consumer living in a residence of assisted living. A patient of unspecified age and gender received COVID-19 Vaccine (unsure if BNT162B2 Pfizer-BioNTech or Moderna vaccine), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, on an unknown date after vaccination, the patient was tested for COVID-19 and was positive. The event onset date and outcome were unknown at the time of the report.  Information on lot/batch number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, X-ray
Clinical narrative: her face got swollen something like that; This is a spontaneous report. A contactable consumer (patient) reported that a 77-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 16Jan2021 at a single dose for COVID-19 immunization. Medical history included tooth canal/a tooth it's going bad on Jan2021. Concomitant medication included celecoxib (CELEBREX), and levothyroxine sodium (SYNTHROID). The patient took the first vaccine and what happened is that she had a tooth canal then right after. The first dose happened on the 16Jan2021 which is last Saturday then after that it seems that the effect that her face got swollen something like that on an unspecified date in Jan2021. The patient stated, "Yes, but it has nothing to do with the vaccine or an allergic reaction. It's just a tooth it's going bad. So I needed to go to the dentist and probably get an antibiotic (Unspecified medication captured as suspect) for it but I wanted to make sure that's not going to negate the strings of my vaccine. I didn't know what it would do to that. No, it's not because of the vaccine. I had actually had it X-rayed on the 13th and he didn't see anything that looked bad but it's gotten worse and it has pores, two pores it has nothing to do with the vaccine. I just I am concern about getting an antibiotic because I don't want it to affect my vaccine. As I said before the vaccine has nothing to do with my problem." The patient underwent lab tests and procedures which included X-ray: didn't see anything that looked bad but it's gotten worse and it has pores, two pores on 13Jan2021. The outcome of the event was unknown.; Sender's Comments: Face swelling is not related to the vaccine use but due to the underlying tooth canal issue.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Electrocardiogram normal, Feeling abnormal, Headache, Nausea
Clinical narrative: feeling funny; anxiety attacks; nervous; Headache; Nauseous; This is a spontaneous report from a contactable consumer(patient).  A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. Patient experienced feeling funny, anxiety attacks and nervous on 16Jan2021, and went to emergency room due to feeling funny, anxiety attacks and nervous, patient also experienced headaches, went to physician office visit and a little nauseous in Jan2021. It was reported that patient received the first shot on 16Jan2021. Immediately after the shot went in(16Jan2021), patient started feeling funny. So, patient was right in the hospital anyway, patient just went to the emergency room and they checked patient up and they just gave patient prednisone, patient do not know why they gave patient Prednisone thinking patient was having anxiety attacks or something and they did an Electrocardiogram(EKG) said patient was fine. Patient took the Prednisone a couple of days because it made patient nervous but patient was still having headaches and a little nauseous and its since Saturday, last Saturday. Treatment received for all events. Outcome of headache and nauseous was not recovered, of other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Nervousness
Clinical narrative: feeling funny; anxiety attacks; nervous; Headache; Nauseous; This is a spontaneous report from a contactable consumer(patient).  A patient of unspecified age and gender received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL1283), via an unspecified route of administration on 16Jan2021 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. Patient experienced feeling funny, anxiety attacks and nervous on 16Jan2021, and went to emergency room due to feeling funny, anxiety attacks and nervous, patient also experienced headaches, went to physician office visit and a little nauseous in Jan2021. It was reported that patient received the first shot on 16Jan2021. Immediately after the shot went in(16Jan2021), patient started feeling funny. So, patient was right in the hospital anyway, patient just went to the emergency room and they checked patient up and they just gave patient prednisone, patient do not know why they gave patient Prednisone thinking patient was having anxiety attacks or something and they did an Electrocardiogram(EKG) said patient was fine. Patient took the Prednisone a couple of days because it made patient nervous but patient was still having headaches and a little nauseous and its since Saturday, last Saturday. Treatment received for all events. Outcome of headache and nauseous was not recovered, of other events was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Body height, Body temperature, Chills, Pyrexia, SARS-CoV-2 test
Clinical narrative: chills; feverish; shakes; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EH9899), via an unspecified route of administration on 21Jan2021 11:00 at SINGLE DOSE for covid-19 immunisation. Medical history included Blood pressure, Acid reflux, urinary tract. Concomitant medication included enalapril (ENALAPRIL) for Blood pressure, omeprazole (OMEPRAZOLE) for Acid reflux, and took another pill (Unspecified Medication) for urinary tract (Not clarified), 10 mg a day. The consumer reported she had the COVID vaccine 22Jan2021 11:00, was great all day, had no reaction, felt fine, ate, was active and then about 8:15 at night all of a sudden, she started to get the shakes and the chills and was feverish and she guessed it was an adverse reaction to the vaccine or side effect she did not know. Right now she was normal, slept okay but she was just wondering was this a normal. She took 2 Tylenol every night 4-5 hours, 500 mg took 2. The consumer meaned they don't even say this on the form if you get this reaction what you could take so she took it myself and it did help, the fever reducer. The patient underwent lab tests and procedures which included body height was 5 foot 5 and a quarter on an unknown date; body temperature was 101.2 on 21Jan2021, and 98.6 in Jan2021, Swab test on Tuesday (unknown date) with unknown result, didn't get the result yet. The event outcome was recovered in Jan2021.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: chills; feverish; shakes; This is a spontaneous report from a contactable consumer (patient). A 70-years-old female patient received first dose of bnt162b2 (BNT162B2, lot number: EH9899), via an unspecified route of administration on 21Jan2021 11:00 at SINGLE DOSE for covid-19 immunisation. Medical history included Blood pressure, Acid reflux, urinary tract. Concomitant medication included enalapril (ENALAPRIL) for Blood pressure, omeprazole (OMEPRAZOLE) for Acid reflux, and took another pill (Unspecified Medication) for urinary tract (Not clarified), 10 mg a day. The consumer reported she had the COVID vaccine 22Jan2021 11:00, was great all day, had no reaction, felt fine, ate, was active and then about 8:15 at night all of a sudden, she started to get the shakes and the chills and was feverish and she guessed it was an adverse reaction to the vaccine or side effect she did not know. Right now she was normal, slept okay but she was just wondering was this a normal. She took 2 Tylenol every night 4-5 hours, 500 mg took 2. The consumer meaned they don't even say this on the form if you get this reaction what you could take so she took it myself and it did help, the fever reducer. The patient underwent lab tests and procedures which included body height was 5 foot 5 and a quarter on an unknown date; body temperature was 101.2 on 21Jan2021, and 98.6 in Jan2021, Swab test on Tuesday (unknown date) with unknown result, didn't get the result yet. The event outcome was recovered in Jan2021.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Paranasal sinus hypersecretion, Sneezing
Clinical narrative: Cold symptoms; Congestion and sneezing and some sinus drainage, I feel like I have cold; Sneezing, congestion and drainage like common cold.; Congestion and sneezing and some sinus drainage, I feel like I have cold; Sneezing, congestion and drainage like common cold.; Congestion and sneezing and some sinus drainage, I feel like I have cold; Sneezing, congestion and drainage like common cold.; This is a spontaneous report from a contactable consumer reporting for himself.   A 69-years-old male patient received bnt162b2 (BNT162B2; Lot # EL1283) vaccine , via an unspecified route of administration on 21Jan2021 08:30 at single dose for Covid-19 immunisation .  The patient medical history and concomitant medications were not reported.  The patient experienced cold symptoms  on 22Jan2021 with outcome of unknown , congestion and sneezing and some sinus drainage, i feel like i have cold on 22Jan2021 with outcome of unknown. The patient used nasal spry of fluticasone as a treatment.  Follow up information has been requested
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: I did have a low grade fever this morning of 101; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot/batch number and expiry date were not provided), via an unspecified route of administration on 21Jan2021 16:00 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  When probed for the concern, consumer stated, patient had a vaccine yesterday (21Jan2021) afternoon about 4 o'clock, patient had got the sheet about the side effects and some of those you know patient was not concerned about but patient did have a low grade fever this morning of 101 on 22Jan2021, patient's HR person has asked if patient would call to find out if that should be something that we should be alarmed of, if patient should not be at work or is that just a side effect from that, from the vaccine that should not be a concern.".  The outcome of the event was unknown.  Information about Lot/Batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; Fever; Aching; Horrible headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249), 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 chills, fever, aching, horrible headache all on an unspecified date with outcome of unknown.  The patient wanted to know if could take Tylenol.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fungal infection
Clinical narrative: Yeast infection; This is a spontaneous report from a contactable consumer (patient). A 74-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL3249), via an unspecified route of administration on 20Jan2021 at single dose for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medications included lots of medication but none of them ever bother him to take them all of the time. The patient previously took Jardiance and experienced yeast infection. The patient experienced yeast infection from the virus injection. Consumer stated It started yesterday, he was trying to treat it. Treatment included Triamcinolone acetonide cream, Ketoconazole that's a cream and he mix it up with Milk of magnesia, from his Dermatologist. The outcome of the event was not recovered.
Age: 73.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain, Vaccination site paraesthesia
Clinical narrative: All I felt was a real tingling pain where I got the vaccine; All I felt was a real tingling pain where I got the vaccine; This is a spontaneous report from a contactable consumer (patient). A 73-year-old patient of unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Patient received first dose of the Pfizer COVID vaccine yesterday (21Jan2021). Patient had some severe symptoms after receiving the vaccine. It was not bad at first right after when he/she got the vaccine. After he/she got the vaccine he/she sat in the area of the hospital for 15 minutes. All he/she felt was a real tingling pain where he/she got the vaccine but when he/she came home the pain stopped (21Jan2021). So patient knows it is related to the vaccine and 'none of them like but patient' and they are getting better and patient just wanted to report it to Pfizer because when patient left the hospital they gave him/her this fact sheet where he/she could call Pfizer and he/she could call other places when he/she have severe symptoms. Outcome of the events was recovered on 21Jan2021.   Information about batch/lot number requested.
Age: 73.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Injection site pain, Mobility decreased, Musculoskeletal stiffness, Neck pain, Pain
Clinical narrative: All I felt was a real tingling pain where I got the vaccine; All I felt was a real tingling pain where I got the vaccine; This is a spontaneous report from a contactable consumer (patient). A 73-year-old patient of unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Patient received first dose of the Pfizer COVID vaccine yesterday (21Jan2021). Patient had some severe symptoms after receiving the vaccine. It was not bad at first right after when he/she got the vaccine. After he/she got the vaccine he/she sat in the area of the hospital for 15 minutes. All he/she felt was a real tingling pain where he/she got the vaccine but when he/she came home the pain stopped (21Jan2021). So patient knows it is related to the vaccine and 'none of them like but patient' and they are getting better and patient just wanted to report it to Pfizer because when patient left the hospital they gave him/her this fact sheet where he/she could call Pfizer and he/she could call other places when he/she have severe symptoms. Outcome of the events was recovered on 21Jan2021.   Information about batch/lot number requested.
Age: 73.0
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: All I felt was a real tingling pain where I got the vaccine; All I felt was a real tingling pain where I got the vaccine; This is a spontaneous report from a contactable consumer (patient). A 73-year-old patient of unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Patient received first dose of the Pfizer COVID vaccine yesterday (21Jan2021). Patient had some severe symptoms after receiving the vaccine. It was not bad at first right after when he/she got the vaccine. After he/she got the vaccine he/she sat in the area of the hospital for 15 minutes. All he/she felt was a real tingling pain where he/she got the vaccine but when he/she came home the pain stopped (21Jan2021). So patient knows it is related to the vaccine and 'none of them like but patient' and they are getting better and patient just wanted to report it to Pfizer because when patient left the hospital they gave him/her this fact sheet where he/she could call Pfizer and he/she could call other places when he/she have severe symptoms. Outcome of the events was recovered on 21Jan2021.   Information about batch/lot number requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Parosmia
Clinical narrative: Medicinal sensation up in the upper palate of mouth about 3 or 4 minutes same sensation in the back of throat when I would breathe in I would feel; Almost like I could smell it; Medicinal sensation up in the upper palate of mouth about 3 or 4 minutes same sensation in the back of throat when I would breathe in I would feel; Almost like I could smell it; This is a Spontaneous report from a contactable consumer (patient).  A 71-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3249), via an unspecified route of administration on 17Jan2021 at single dose for COVID-19 immunisation. Medical history included breast cancer. The patient's concomitant medications were not reported. The patient experienced medicinal sensation up in the upper palate of mouth about 3 or 4 minutes same sensation in the back of throat when she would breathe in she would feel; almost like she could smell it on 17Jan2021 with outcome of recovered on the same day. The patient reported that it didn't taste like anything that she could identify but it was just a medicinal taste. It wasn't metallic. It was just a sensation of an odd presence, an odd breath, an odd air or something in the back of her throat and up in her upper palate and it lasted for about 10 minutes and then it went away. The patient was not treated due to the events.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site mass, Vaccination site pruritus, Vaccination site swelling, Vaccination site warmth
Clinical narrative: I have got a knot on my shoulder; it's swollen; it's real hot and itches real bad; it's real hot and itches real bad; This is a spontaneous report from a contactable consumer (patient).  An 83-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231, expiry date: 30Apr2021), via an unspecified route of administration on 19Jan2021 at single dose for COVID-19 immunization. The patient medical history included blood pressure high from an unknown date and unknown if ongoing. The patient's concomitant medications included losartan for blood pressure high. On Jan2021, the patient reported that: "I have got a knot on my shoulder; it's swollen, it's real hot and itches real bad". The patient outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back ache/back has been bothering me for over a week now; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2, 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. Patient got a back ache from the vaccine. Patient's back had been bothering for over a week now almost (Incomplete sentence). Patient didn't know it didn't seem to go away and took paracetamol (TYLENOL) and it didn't help and patient was wondering if that could be something that the vaccine would cause. Patient was just curious if it would affect back. Outcome of the event was unknown.  Information about Lot/Batch number is requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hypoaesthesia, Oropharyngeal pain, Pruritus
Clinical narrative: I was taken to the ER because I started with numbness in my face and itching; I was taken to the ER because I started with numbness in my face and itching; Terrible headache; Sore throat; Chills; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3302), via an unspecified route of administration at site of left arm on an unspecified date at single dose for COVID-19 immunization. Medical history included blood pressure high and thyroid problems. Concomitant medication included levothyroxine sodium (SYNTHROID) for thyroid problems, spironolactone. The patient just had side effects from the Covid Vaccine (clarified as Pfizer BioNTech Covid Vaccine). Actually when the patient had the shot she was taken to the ER because she started with numbness in face and itching on unknown date but now since that was on Tuesday 19th, so today the patient had a terrible headache, she had sore throat and today she started with chills on unknown date. Before the patient had blood drawn latest before she got shot. The patient was in the hospital, she was given Benadryl, Pepcid and steroid through the IV. The patient had been treating in home with either Tylenol, Ibuprofen, Excedrin Migraine, Aleve, she mean, trying to relief the headache and it's not helping. The outcome of events was unknown.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. 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 RAs, Ethics Committees, and Investigators, as appropriate.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Hypoaesthesia, Impaired work ability, Injected limb mobility decreased
Clinical narrative: Local nerve injury/significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work; At the time of vaccination he experienced discomfort in left deltoid which was the injection site; Cannot lift his arm greater than 45 degrees; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; This is a spontaneous report from a contactable pharmacist.  A 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular n deltoid left on 09Jan2021 at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  At the time of vaccination he experienced discomfort in left deltoid which was the injection site, cannot lift his arm greater than 45 degrees, local nerve injury, systemic fatigue ,myalgia and other arthralgia for 24-36 hours, developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work or task, all in Jan2021 with outcome of unknown.  He called the employee health on 17Jan2021 and 19Jan2021 he saw a neurosurgeon. The neurosurgeon didn't think it was a cervical spine injury rather a local nerve injury related to the injection itself and he was prescribed a steroids taper, unclear whether if it was a temporary or permanent issue. Because this was like 10 days after the vaccine and he didn't really describe how much this issue affected his ability to perform usual work or task but he was a surgeon. The outcome of the events were unknown.; Sender's Comments: Based on the compatible time association, the peripheral nerve injury is possibly related to the injection technique, not vaccine BNT162B2. 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: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site discomfort, Injection site muscle weakness, Injection site nerve damage, Local reaction, Loss of personal independence in daily activities
Clinical narrative: Local nerve injury/significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work; At the time of vaccination he experienced discomfort in left deltoid which was the injection site; Cannot lift his arm greater than 45 degrees; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; This is a spontaneous report from a contactable pharmacist.  A 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular n deltoid left on 09Jan2021 at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  At the time of vaccination he experienced discomfort in left deltoid which was the injection site, cannot lift his arm greater than 45 degrees, local nerve injury, systemic fatigue ,myalgia and other arthralgia for 24-36 hours, developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work or task, all in Jan2021 with outcome of unknown.  He called the employee health on 17Jan2021 and 19Jan2021 he saw a neurosurgeon. The neurosurgeon didn't think it was a cervical spine injury rather a local nerve injury related to the injection itself and he was prescribed a steroids taper, unclear whether if it was a temporary or permanent issue. Because this was like 10 days after the vaccine and he didn't really describe how much this issue affected his ability to perform usual work or task but he was a surgeon. The outcome of the events were unknown.; Sender's Comments: Based on the compatible time association, the peripheral nerve injury is possibly related to the injection technique, not vaccine BNT162B2. 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: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Mobility decreased, Muscular weakness, Myalgia, Nerve injury, Peripheral nerve injury
Clinical narrative: Local nerve injury/significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work; At the time of vaccination he experienced discomfort in left deltoid which was the injection site; Cannot lift his arm greater than 45 degrees; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Systemic fatigue ,myalgia and other arthralgia for 24-36 hours; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; Developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle; This is a spontaneous report from a contactable pharmacist.  A 45-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EK9231), intramuscular n deltoid left on 09Jan2021 at single dose for COVID-19 immunization.  The patient medical history was not reported.  The patient's concomitant medications were not reported.  At the time of vaccination he experienced discomfort in left deltoid which was the injection site, cannot lift his arm greater than 45 degrees, local nerve injury, systemic fatigue ,myalgia and other arthralgia for 24-36 hours, developed significant numbness and weakness in his upper extremities specifically in his left deltoid muscle, affects his ability to perform usual work or task, all in Jan2021 with outcome of unknown.  He called the employee health on 17Jan2021 and 19Jan2021 he saw a neurosurgeon. The neurosurgeon didn't think it was a cervical spine injury rather a local nerve injury related to the injection itself and he was prescribed a steroids taper, unclear whether if it was a temporary or permanent issue. Because this was like 10 days after the vaccine and he didn't really describe how much this issue affected his ability to perform usual work or task but he was a surgeon. The outcome of the events were unknown.; Sender's Comments: Based on the compatible time association, the peripheral nerve injury is possibly related to the injection technique, not vaccine BNT162B2. 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: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood potassium, Blood test, Gait disturbance
Clinical narrative: Pneumonia; She increasingly today has not been able to take straight steps forward, she walks like she is drunk; This is a spontaneous report from a contactable consumer. A 73-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# EL8982), via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunization, pregabalin (LYRICA, Pfizer product), phenytoin sodium (DILANTIN, Pfizer product), levetiracetam (KEPPRA, non-Pfizer product), all via an unspecified route of administration from an unspecified date at unspecified dose for an unspecified indication.   Medical history included Major Epilepsy issues from an unknown date and unknown if ongoing. Concomitant medication included sertraline hydrochloride (Generic of Zoloft). The patient got the shot, she had no pain or anything like that but she increasingly today has not been able to take straight steps forward, she walks like she is drunk. She is on Lyrica, she is on Dilantin and she is on Keppra and the reporter was wondering if there is any relationship between the actions we are seeing from her today from the shot and concerned if that could be a reaction. The patient did not have the second dose yet. The patient had pneumonia in Dec so she was checking for potassium levels but the reporter didn't know if the patient did a CBC or what other. Treatment: Reporter stated, "It just started today." The patient underwent lab tests and procedures which included potassium levels and blood work with unknown results. The action taken in response to the events for pregabalin, phenytoin sodium and levetiracetam was unknown. The outcome of all the events was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Nasopharyngitis, Pain in extremity, Respiratory disorder, Rhinorrhoea
Clinical narrative: He had some drainage I guess his nose, it was flowing; I woke up with a lot of drainages like allergies/ scratchy nose; Left arm was sore; Light-headed; Blurry vision; He has a scratchy throat like a sinus or a head cold symptoms; He has a scratchy throat like a sinus or a head cold symptoms; He has a scratchy throat like a sinus or a head cold symptoms; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on left arm muscle on 18Jan2021 at single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFib, had a pace maker), Kidney problems (It was stage III on kidneys functioning about 45 percent. patient also saw a Urologist because the patient did have a Cyst, he thought in one of his kidneys, they kept a close eye on to see how it was progressing), Pulmonary problems, blood thinner which the patient share with them before he got the shot. Concomitant medication included warfarin sodium (COUMADIN) as blood thinner which he share with them before he got the shot and unspecified medication. The day of the vaccination on 18Jan2021, he felt light headed, blurry vision, it lasted for 30 minutes and it subsided. Day 2 Tuesday on 19Jan2021, his total left arm was sore where they gave him the vaccine all the way down. Day 3 on 20Jan2021, he had some drainage the patient guessed his nose, it was flowing until he took some Benadryl medication which helped him over night. He said the same thing today but he said he had a scratchy throat like a sinus or a head cold symptoms. The only thing she could find was sometime allergic condition that were called like allergy in the throat scratchiness but she didn't say anything about any drainage so he didn't think that really what he was having. The outcome of events light-headed, blurry vision, runny nose was recovering. The outcome of rest events was unknown.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation, Vision blurred
Clinical narrative: He had some drainage I guess his nose, it was flowing; I woke up with a lot of drainages like allergies/ scratchy nose; Left arm was sore; Light-headed; Blurry vision; He has a scratchy throat like a sinus or a head cold symptoms; He has a scratchy throat like a sinus or a head cold symptoms; He has a scratchy throat like a sinus or a head cold symptoms; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received his first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL0142), via an unspecified route of administration on left arm muscle on 18Jan2021 at single dose for COVID-19 immunization. Medical history included atrial fibrillation (AFib, had a pace maker), Kidney problems (It was stage III on kidneys functioning about 45 percent. patient also saw a Urologist because the patient did have a Cyst, he thought in one of his kidneys, they kept a close eye on to see how it was progressing), Pulmonary problems, blood thinner which the patient share with them before he got the shot. Concomitant medication included warfarin sodium (COUMADIN) as blood thinner which he share with them before he got the shot and unspecified medication. The day of the vaccination on 18Jan2021, he felt light headed, blurry vision, it lasted for 30 minutes and it subsided. Day 2 Tuesday on 19Jan2021, his total left arm was sore where they gave him the vaccine all the way down. Day 3 on 20Jan2021, he had some drainage the patient guessed his nose, it was flowing until he took some Benadryl medication which helped him over night. He said the same thing today but he said he had a scratchy throat like a sinus or a head cold symptoms. The only thing she could find was sometime allergic condition that were called like allergy in the throat scratchiness but she didn't say anything about any drainage so he didn't think that really what he was having. The outcome of events light-headed, blurry vision, runny nose was recovering. The outcome of rest events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Malaise, Myalgia, Pyrexia
Clinical narrative: I woke up this morning not feeling great; I don't feel well; Joint pain; Muscle pain; Fever; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# FL3247 or EL3247) via an unspecified route of administration on 21Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient had no problems in the evening of 21Jan2021. The patient woke up this morning on 22Jan2021 and was not feeling great. The patient had some muscle pain, little more intense during the day, joint pain and muscle pain and now the patient had a fever. The patient had thermometer and it said 101.2. The outcome of events was unknown.  Information on Lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Hypoaesthesia, Neck pain
Clinical narrative: I feel little tired and stuff; Shoulder pain; Neck pain; my arm look like it's getting numb; I have my left side of my head is feeling like pain; Pain on my arm is getting so bad; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at 15:00 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On 22Jan2021, the patient reported that: " in morning I wasn't bad I feel little tired and stuff, but afternoon I am experiencing a very huge shoulder pain, neck pain and my arm look like it's getting numb. I have my left side of my head is feeling like pain. Pain on my arm is getting so bad". The patient outcome of the events was unknown.  The information on the batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: I feel little tired and stuff; Shoulder pain; Neck pain; my arm look like it's getting numb; I have my left side of my head is feeling like pain; Pain on my arm is getting so bad; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Jan2021 at 15:00 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On 22Jan2021, the patient reported that: " in morning I wasn't bad I feel little tired and stuff, but afternoon I am experiencing a very huge shoulder pain, neck pain and my arm look like it's getting numb. I have my left side of my head is feeling like pain. Pain on my arm is getting so bad". The patient outcome of the events was unknown.  The information on the batch number has been requested.