chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oropharyngeal pain, Panic reaction, Pharyngeal swelling, Swollen tongue
Clinical narrative: tightening and swelling in her throat; tightening and swelling in her throat; slight swelling of the tongue; panicky, uncomfortable feeling; panicky, uncomfortable feeling; headache; Sore throat; Extreme tiredness; achy joints; sore muscles; generally feeling sick/unwell; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration at right arm on 23Jan2021 13:30 at a single dose for  COVID-19 immunization.  Medical history included ongoing hypothyroidism (has had for 15 years or so). The patient's concomitant medications were not reported. The patient previously took glycerin and had allergy (has been allergic to glycerin for at least ten years). The patient received the Covid-19 vaccine on Saturday. About 10-15 seconds after receiving it, she felt like it was moving up her arm. She also had a headache and sore throat on the same day. About 20 minutes later at 13:50, she had a tightening and swelling in her throat. It was a panicky, uncomfortable feeling. She reported a "narrowing of my airway" and slight swelling of the tongue/back-of throat. She was unsure if she should wait or go to the emergency room. She took some deep breaths and waited it out. It went away 40 minutes later. She also reported feeling extreme tiredness, achy joints, sore muscles, a headache, and generally feeling sick/unwell in Jan2021. The events did not require a visit to Emergency Room and Physician Office. No prior vaccinations (within 4 weeks). The outcome of the event headache and sore throat was recovering; event tightening and slight swelling of the tongue/swelling of throat was recovered/resolved with sequel on 23Jan2021; and unknown outcome for the other events.  Information on the lot/ batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: tightening and swelling in her throat; tightening and swelling in her throat; slight swelling of the tongue; panicky, uncomfortable feeling; panicky, uncomfortable feeling; headache; Sore throat; Extreme tiredness; achy joints; sore muscles; generally feeling sick/unwell; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration at right arm on 23Jan2021 13:30 at a single dose for  COVID-19 immunization.  Medical history included ongoing hypothyroidism (has had for 15 years or so). The patient's concomitant medications were not reported. The patient previously took glycerin and had allergy (has been allergic to glycerin for at least ten years). The patient received the Covid-19 vaccine on Saturday. About 10-15 seconds after receiving it, she felt like it was moving up her arm. She also had a headache and sore throat on the same day. About 20 minutes later at 13:50, she had a tightening and swelling in her throat. It was a panicky, uncomfortable feeling. She reported a "narrowing of my airway" and slight swelling of the tongue/back-of throat. She was unsure if she should wait or go to the emergency room. She took some deep breaths and waited it out. It went away 40 minutes later. She also reported feeling extreme tiredness, achy joints, sore muscles, a headache, and generally feeling sick/unwell in Jan2021. The events did not require a visit to Emergency Room and Physician Office. No prior vaccinations (within 4 weeks). The outcome of the event headache and sore throat was recovering; event tightening and slight swelling of the tongue/swelling of throat was recovered/resolved with sequel on 23Jan2021; and unknown outcome for the other events.  Information on the lot/ batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature, Bone pain, Chills, Cold sweat, Fatigue
Clinical narrative: 103.5 degree Fahrenheit fever while taking Acetaminophen every 6 hrs; extreme fatigue bedridden; chills; cold sweats; bone pain/aching; administration date=11Jan2021, dose number=2/administration date=30Dec2020, dose number=1; This is a spontaneous report from a contactable other health professional (patient). This 36-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular at left arm on 11Jan2021 11:15 AM at single dose for COVID-19 immunization. Medical history was unknown. The patient had no allergies to medications, food, or other products. Concomitant medications included venlafaxine hydrochloride (EFFEXOR XR). The patient previous received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular at left arm on 30Dec2020 09:15 AM at 36-year old for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 103.5 degree Fahrenheit fever while taking Tylenol every 6 hrs, extreme fatigue bedridden, chills and cold sweats, bone pain/aching on 12Jan2021 04:00 AM. No treatment was received for the adverse even. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered with sequel. Seriousness criteria was reported as non-serious.   Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Inappropriate schedule of product administration, Pyrexia
Clinical narrative: 103.5 degree Fahrenheit fever while taking Acetaminophen every 6 hrs; extreme fatigue bedridden; chills; cold sweats; bone pain/aching; administration date=11Jan2021, dose number=2/administration date=30Dec2020, dose number=1; This is a spontaneous report from a contactable other health professional (patient). This 36-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular at left arm on 11Jan2021 11:15 AM at single dose for COVID-19 immunization. Medical history was unknown. The patient had no allergies to medications, food, or other products. Concomitant medications included venlafaxine hydrochloride (EFFEXOR XR). The patient previous received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular at left arm on 30Dec2020 09:15 AM at 36-year old for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 103.5 degree Fahrenheit fever while taking Tylenol every 6 hrs, extreme fatigue bedridden, chills and cold sweats, bone pain/aching on 12Jan2021 04:00 AM. No treatment was received for the adverse even. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered with sequel. Seriousness criteria was reported as non-serious.   Information on the lot/batch number has been requested.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Body temperature increased
Clinical narrative: 103.5 degree Fahrenheit fever while taking Acetaminophen every 6 hrs; extreme fatigue bedridden; chills; cold sweats; bone pain/aching; administration date=11Jan2021, dose number=2/administration date=30Dec2020, dose number=1; This is a spontaneous report from a contactable other health professional (patient). This 36-year-old female patient received the 2nd dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular at left arm on 11Jan2021 11:15 AM at single dose for COVID-19 immunization. Medical history was unknown. The patient had no allergies to medications, food, or other products. Concomitant medications included venlafaxine hydrochloride (EFFEXOR XR). The patient previous received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via intramuscular at left arm on 30Dec2020 09:15 AM at 36-year old for COVID-19 immunization. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced 103.5 degree Fahrenheit fever while taking Tylenol every 6 hrs, extreme fatigue bedridden, chills and cold sweats, bone pain/aching on 12Jan2021 04:00 AM. No treatment was received for the adverse even. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovered with sequel. Seriousness criteria was reported as non-serious.   Information on the lot/batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Ear disorder, Hypoacusis, Lymphadenopathy, Pain
Clinical narrative: It felt like there was water in the ear; The right cheek was swollen; lymph nodes were swollen; He felt a pressure in the right ear; It impaired his hearing due to the pressure/trouble hearing; The face felt achy with hives; The face felt achy with hives; This is a spontaneous report from a contactable pharmacist (patient's wife).   A 63-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EL9262), via an unspecified route of administration injection in the left upper arm on at a single dose on 21Jan2021,10:00 for covid-19 immunization. Relevant medical history included blood pressure (unspecified), diabetes, stomach acidity, lipid lowering all from an unknown date and unknown if ongoing. Ongoing concomitant medications included irbesartan blood pressure, metformin for diabetes, famotidine for stomach acidity, atorvastatin for lipid lowering colecalciferol (vitamin D) for unknown indication. The patient experienced lymph nodes were swollen, felt a pressure in the right ear, felt like there was water in the ear, right cheek was swollen on 21Jan2021 17:00; impaired hearing due to the pressure/trouble hearing, face felt achy with hives on 21Jan2021. The events were mild, thought it would go away by itself. The events did not require a visit to emergency room and physician's office. It was further reported that around 5-6 hours after getting the vaccine, in the evening, he started to have the lymph nodes on the right side of his face swelling. Along with that he had trouble hearing. It was like swimming and lots of water got in the ear and that water could not come out. He also had hives. He had hives under his eye. It was like on his cheek between his eye. It was red and about the size if a finger nail. She would like to speak to someone about him taking the second dose. She wanted to know if there was any concern in him getting the second dose. The issues with trouble hearing is getting better, he is almost back to normal. When he touches his ear it still feels sensitive. The hives is still there, but it is like paler, but still there. It is like weaker at this point . Outcome of the event lymph nodes were swollen, impaired hearing due to the pressure/trouble hearing, face felt achy with hives was recovering, while unknown outcome for the event pressure in the right ear, felt like there was water in the ear, right cheek was swollen was unknown.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: It felt like there was water in the ear; The right cheek was swollen; lymph nodes were swollen; He felt a pressure in the right ear; It impaired his hearing due to the pressure/trouble hearing; The face felt achy with hives; The face felt achy with hives; This is a spontaneous report from a contactable pharmacist (patient's wife).   A 63-year-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot:EL9262), via an unspecified route of administration injection in the left upper arm on at a single dose on 21Jan2021,10:00 for covid-19 immunization. Relevant medical history included blood pressure (unspecified), diabetes, stomach acidity, lipid lowering all from an unknown date and unknown if ongoing. Ongoing concomitant medications included irbesartan blood pressure, metformin for diabetes, famotidine for stomach acidity, atorvastatin for lipid lowering colecalciferol (vitamin D) for unknown indication. The patient experienced lymph nodes were swollen, felt a pressure in the right ear, felt like there was water in the ear, right cheek was swollen on 21Jan2021 17:00; impaired hearing due to the pressure/trouble hearing, face felt achy with hives on 21Jan2021. The events were mild, thought it would go away by itself. The events did not require a visit to emergency room and physician's office. It was further reported that around 5-6 hours after getting the vaccine, in the evening, he started to have the lymph nodes on the right side of his face swelling. Along with that he had trouble hearing. It was like swimming and lots of water got in the ear and that water could not come out. He also had hives. He had hives under his eye. It was like on his cheek between his eye. It was red and about the size if a finger nail. She would like to speak to someone about him taking the second dose. She wanted to know if there was any concern in him getting the second dose. The issues with trouble hearing is getting better, he is almost back to normal. When he touches his ear it still feels sensitive. The hives is still there, but it is like paler, but still there. It is like weaker at this point . Outcome of the event lymph nodes were swollen, impaired hearing due to the pressure/trouble hearing, face felt achy with hives was recovering, while unknown outcome for the event pressure in the right ear, felt like there was water in the ear, right cheek was swollen was unknown.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Abnormal faeces, Diarrhoea, Frequent bowel movements
Clinical narrative: chronic case of diarrhea- the loose stool had a strong chemical stench; chronic case of diarrhea- the loose stool had a strong chemical stench; I did about 7 bowel movements all night until next morning; This is a spontaneous report from a contactable consumer (reported for himself). An 86-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: E19262; expiry date: not known), via an unspecified route of administration in the right arm on 23Jan2021 13:30 at single dose for COVID-19 immunization. Medical history included 2 heart surgeries- 1 triple and 1 double. Concomitant medications included lisinopril, metoprolol, and tamsulosin. The patient did not receive any other vaccines within 4 weeks prior to COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 24Jan2021 01:00 (reported as 'Sunday evening past midnight'; pending clarification), the patient had to get up and run to the bathroom with a chronic case of diarrhea- the loose stool had a strong chemical stench. He did about 7 bowel movements all night until next morning. The patient asked if it was a reaction to the COVID-19 (vaccination). The reported events were assessed as non-serious. The outcome of the events was recovering.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: started to throw up, was vomiting; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information team. A 75-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; batch/lot number and expiration date were unknown), via an unspecified route of administration on the left arm (reported as left upper arm) on 23Jan2021 at 11:00 at a single dose for COVID-19 immunization. The vaccination facility type was reported as the clinic. The patient had no medical history. She had no family medical history relevant to the adverse event (AE). The patient's concomitant medications were not reported. The patient did not receive any other vaccines that day. She did get a flu shot maybe a month prior reporting or longer and again mentioned she had no problems with vaccines in the past. She did remember getting a pneumonia shot and another one that she did not remember the name of. She got flu shots every year. The patient had no history of previous immunization with a Pfizer vaccine. The patient explained she experienced vomiting 12 hours after the injection of the first dose of the COVID-19 vaccine. She asked if her symptom was a reported side effect for the vaccine. She also asked how to avoid this experience after the second dose of the vaccine. It was further reported that on 23Jan2021 at about 23:00, when she went to bed, she felt like going to the bathroom. She sat down and started to throw up, she was vomiting, and it came so fast without warning. She made a mess and had to take another shower. This was 12 hours after getting the vaccine and the first time she had ever had this happen. She got a flu vaccine every year, since her husband was a nurse and told her to get vaccinated, but she had never had this to happen with any other vaccine in past. This was her first reaction to anything. The patient was asking if this happens to other people. She had been fine since that had happened, but she didn't have any warning and didn't feel nauseous. She had the sheet and it said you could experience nausea, but she didn't. She even checked with her daughter, son-in-law, and grandson who she ate dinner with and no one else was sick and so they think it's the vaccine and didn't come from something they ate. She had to go back in 3 weeks and was given the sheets/paperwork. The patient also reported that she did wait there at least 15 minutes after getting it to make sure no bad reactions occurred immediately afterwards and she didn't and she figured she wouldn't. The patient thought this one was different. The AE did not require any visit to an emergency room or a physician office. The patient had no relevant tests or investigation assessment. The patient was recovering from the event.  Information on the batch/lot number has been requested.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Heart rate, Laboratory test, Pain in extremity
Clinical narrative: My blood pressure was a little elevated, high for me / elevated blood pressure; Arm sore; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: FL3246, expiry date not reported), via an unspecified route of administration in the left arm on 23Jan2021 at single dose for COVID-19 immunization. Medical history included ongoing thyroid disorder. Concomitant medication included hctz. The patient experienced that her blood pressure was a little elevated, high for her/elevated blood pressure on an unspecified date. On 25Jan2021, the patient experienced arm sore. The patient underwent lab tests and procedures which included blood pressure measurement: 160/88 on an unspecified date, blood pressure measurement: normal (reported as normally around 130, 135, 138, normally runs 140/35-38), heart rate: 85 on an unspecified date, laboratory test: unknown result on an unspecified date. Clinical outcome of arm sore was recovering, while for blood pressure increased was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dizziness
Clinical narrative: lightheaded; elevated blood pressure; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 21Jan2021 at SINGLE DOSE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 21Jan2021, the patient experienced lightheaded, and elevated blood pressure. The patient underwent lab tests and procedures which included blood pressure measurement: elevated. The outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program. A contactable physician reported that a 59-year-old female patient received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number requested), intramuscular on 11Jan2021 at a single dose for COVID-19 immunization.  Medical history included obesity from an unknown date and unknown if ongoing and ongoing stress.  There were no concomitant medications. It was reported that the patient developed Shingles on 16Jan2021, which was 5 days after receiving the first dose of the COVID-19 vaccine, on 11Jan2021. The patient received Valtrex as treatment for the event. The physician stated that she wants to say that it was not serious but she is not sure but reported that the patient is ok. This was the first time the patient was diagnosed with shingles. The physician added that the patient's lesions are getting better but she still has nerve pain and was prescribed gabapentin. It was also reported that the patient stated that there are other reasons such as stress as to why she developed shingles, like loss of a family member and loss of her client. It was clarified that the patient is stressed since she works for a senior care facility and co-workers and clients have lost their lives. She lost her mom last year and stated that she basically has stress in her life.  The patient is scheduled for her second dose on 01Feb2020 and asked the physician if she could get the second dose. The physician doesn't see any reason why the patient wouldn't be able to receive it. The physician did not think it was a problem but she called Pfizer to ask if the patient should get the second dose and asked for recommendations on administering the second dose to her patient. The outcome of the event was recovering.   Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Lymphadenopathy
Clinical narrative: Enlarged lymph node; soreness above left clavicle; This is a spontaneous report from a contactable other health professional (patient). A 50-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date unknown), via an unspecified route of administration on 21Jan2021 08:00 at a single dose on left arm for COVID-19 immunization. The patient medical history were not reported. There were no concomitant medications. The patient previously took keflex [cefalexin monohydrate] and experienced allergies. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: ELO142), via an unspecified route of administration on 31Dec2020 13:00 at a single dose on left arm for COVID-19 immunization. The patient experienced enlarged lymph node and soreness above left clavicle on 21Jan2021 20:00. No treatment received for the events. The outcome of the events was not recovered. The events were considered as non-serious. The patient was not pregnant. No other vaccines within 4 weeks prior to the COVID vaccine. Not diagnosed with COVID prior vaccination. Not COVID tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was at the Hospital.  Information on the lot/batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Pruritus, Rash macular, Weight
Clinical narrative: Little red spot here and there; He woke up with itching all over; This is a spontaneous report from a contactable consumer. A 75-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL9261), via an unspecified route of administration on 21Jan2021 at 0.3 mL, single for COVID-19 immunization. Medical history included Heart disease, Diabetes, Atrial fibrillation (AFib), Gastrooesophageal reflux disease (GERD), shellfish allergy, heart surgery, quadruple bypass, allergic reactions and hives. Concomitant medications included apixaban (ELIQUIS) for AFib, clopidogrel bisulfate (PLAVIX) as blood thinner, metformin hydrochloride (METFORMIN ER) for Diabetes, Atorvastatin, Metoprolol Succinate (ER), pantoprazole sodium sesquihydrate (PROTONIX) for GERD, and Losartan potassium to protect kidneys from diabetes. The patient had an anaphylactic shock reaction in past and requires an epi pen for the past 30 years but was unsure what he was allergic to. During his allergic reactions, he usually has hives but with this reaction he has no hives, no difficulty. The patient got the Pfizer vaccine (COVID-19 Vaccine) on 21Jan2021, last Thursday. He had no symptoms, no problems that evening. The next night at 1 in the morning he woke up with itching all over. He took some Benadryl and did not go away. Took a little more Benadryl, finally he was up about 2 hours with this itching and then he went to bed and slept quite a while because he had taken Benadryl. The next day he seemed okay, during the day. Then again during the night at 1 'O clock or so he then woke up again with itching all overtook Benadryl again. So, that was on Saturday night. So, Friday night, Saturday night and then Sunday he had the same thing again. The doctor stated that it has been 3 days of itching, so he put him on Medrol Dosepak which the patient got today, so he has just started that. Previously, 30 years ago, he had anaphylactic shock and they were never able to figure out exactly ran all kind of tests, never found out what exactly was he had the allergic reaction to. He had in the past but not quite a few years now. He would kind of just break out in hives and that. But during this time he really did not get hives, he got today 25Jan2021 a little red spot here and there, that he would be itching. He has no red spots or anything by the site of the injection but there is concern that now he has got to take a Medrol Dosepak (treatment) and kind of hopefully not wake up again tonight with this itching. So, the concern is the next shot. The patient's weight was "199, 200 pounds" (Reporter was not sure). The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dyspnoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: shortness of breath; tiredness; slight headache; joint pain; neck pain; She said she felt terrible and felt as if "somebody beat her with a stick or run her over with a car."; She said she felt unwell; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included an unspecified blood thinner. She mentioned that she experienced side effects after receiving the vaccine on Friday (22Jan2021). She experienced shortness of breath, tiredness, slight headache, joint pain and neck pain. She mentioned that she felt terrible and felt as if "somebody beat her with a stick or run her over with a car." She said she felt unwell. She also mentioned that yesterday, she felt a little better, but still felt tired. The patient inquired if these side effects are normal, and if she should still get the 2nd dose despite experiencing these side effects. She also mentioned that she is on a blood thinner, but said that prior to getting the vaccine, she told the vaccination provider about it. The outcome of the event feeling unwell was unknown while the outcome of the other events was recovering.  The following information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Neck pain
Clinical narrative: shortness of breath; tiredness; slight headache; joint pain; neck pain; She said she felt terrible and felt as if "somebody beat her with a stick or run her over with a car."; She said she felt unwell; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on 22Jan2021 at a single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included an unspecified blood thinner. She mentioned that she experienced side effects after receiving the vaccine on Friday (22Jan2021). She experienced shortness of breath, tiredness, slight headache, joint pain and neck pain. She mentioned that she felt terrible and felt as if "somebody beat her with a stick or run her over with a car." She said she felt unwell. She also mentioned that yesterday, she felt a little better, but still felt tired. The patient inquired if these side effects are normal, and if she should still get the 2nd dose despite experiencing these side effects. She also mentioned that she is on a blood thinner, but said that prior to getting the vaccine, she told the vaccination provider about it. The outcome of the event feeling unwell was unknown while the outcome of the other events was recovering.  The following information on the batch/lot number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: soreness in site of injection; fatigue; This is a spontaneous report from a contactable consumer (patient). A 32-year-old non-pregnant female patient received bnt162b2 (BNT162B2 reported as PFIZER COVID-19 VACCINE; lot number: EL9262; expiration date: unknown), via an unspecified route of administration left arm on 24Jan2021 11:45 at a single dose for covid-19 immunisation. Medical history included IBS (irritable bowel syndrome) and hypercholesterolaemia. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included rosuvastatin calcium (CRESTOR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had soreness in site of injection and fatigue on 24Jan2021 14:00. The events were reported as non-serious. No treatment was received for the adverse event. The patient has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: Facial numbness around right eye; This is a spontaneous report from a contactable physician (patient). A 58-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular first dose (lot number: EH9899) on the left arm on 26Dec2020 07:15 and the second dose (lot number: EL1283) on the left arm on 25Jan2021 07:15 at a single dose for COVID-19 immunization. Medical history included allergies, high cholesterol; known allergies: dust, pollen, trees, grasses. Concomitant medication included ubidecarenone (COQ10 [UBIDECARENONE]), colecalciferol (VITAMIN D [COLECALCIFEROL]), fexofenadine, atorvastatin calcium (ATORVASTIN), montelukast and multivitamins. The patient experienced facial numbness around right eye and migrating 11 hours after injection. Similar sensation 2 weeks after first vaccination in Jan2020. No treatment was received for the event. 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. Post vaccination, the patient has not been tested for COVID-19. Outcome of the event was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Chills, Confusional state, Fatigue
Clinical narrative: Severe myalgia; severe arthralgia; severe Headache; rigors; extreme fatigue; chest pain; palpitations; tachycardia; Confusion; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) intramuscular on the right arm on 12Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included arthritis, B12 deficiency and Allergies: Wasp venom. The patient previously received first dose of BNT162B2 on an 21Dec2020 for COVID-19 immunization (first dose, intramuscular, right arm). Concomitant medication included paracetamol (TYLENOL) and cyanocobalamin (B 12). On 12Jan2021 19:00 PM, the patient experienced severe myalgia, severe arthralgia, severe Headache, rigors, extreme fatigue, chest pain, palpitations, tachycardia. Confusion. Fatigue began approx 6 hours post injection. Other symptoms culminated at around 12 hours post injection. Severe symptoms lasted approx 24 hrs with moderate symptoms following for another 48 hours, followed by mild symptoms for another 12 hours. No treatment was received for the events. Events were reported as non-serious: did not result in death, not life-threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a hospital. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Palpitations, Tachycardia
Clinical narrative: Severe myalgia; severe arthralgia; severe Headache; rigors; extreme fatigue; chest pain; palpitations; tachycardia; Confusion; This is a spontaneous report from a contactable nurse (patient). A 44-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) intramuscular on the right arm on 12Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included arthritis, B12 deficiency and Allergies: Wasp venom. The patient previously received first dose of BNT162B2 on an 21Dec2020 for COVID-19 immunization (first dose, intramuscular, right arm). Concomitant medication included paracetamol (TYLENOL) and cyanocobalamin (B 12). On 12Jan2021 19:00 PM, the patient experienced severe myalgia, severe arthralgia, severe Headache, rigors, extreme fatigue, chest pain, palpitations, tachycardia. Confusion. Fatigue began approx 6 hours post injection. Other symptoms culminated at around 12 hours post injection. Severe symptoms lasted approx 24 hrs with moderate symptoms following for another 48 hours, followed by mild symptoms for another 12 hours. No treatment was received for the events. Events were reported as non-serious: did not result in death, not life-threatening, did not caused/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The facility where the vaccine was administered was in a hospital. Patient was not pregnant. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient has not been tested for COVID-19. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was recovered on an unspecified date.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. A female patient of an unspecified age received bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, Lot number: Unknown), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient medical history includes knee pain. Concomitant medication included ibuprofen (ADVIL), paracetamol (TYLENOL) for knee pain. On an unspecified date, the patient experienced arm pain. She took paracetamol and ibuprofen which for her knee pain. Someone told her that she should not take it. The patient would like to know if that would affect the effectivity of the vaccine. The outcome of the event was unknown.   Information about Lot/Batch has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph nodes; This is a spontaneous report from a contactable other healthcare professional (HCP, patient herself). A 52-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EL3246, expiration date was unknown), via an unspecified route of administration on the left arm on 13Jan2021 at 10:30 at a single dose for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was at the hospital. The patient's medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 24Jan2021 at 10:00, the patient experienced swollen lymph nodes, which was considered non-serious. The adverse event did result in a doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the adverse event. The patient was not recovered from the event.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Stridor, Urticaria
Clinical narrative: Hives on face and neck worsening to stridorous breath sounds.; Hives on face and neck worsening to stridorous breath sounds.; This is a spontaneous report from a contactable nurse. A 47-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247), via an unspecified route of administration in left arm on 21Jan2021 10:15 at a single dose for COVID-19 immunization. Vaccination was done in a hospital. Medical history included asthma, ulcerative colitis, sub clinical Hashimotos, and known allergies to eggs and dairy.  Concomitant medication included mesalamine (MESALAMINE), levocetirizine dihydrochloride (XYZAL), budesonide, formoterol fumarate (SYMBICORT), procaterol hydrochloride (PRO-AIR), and montelukast sodium (SINGULAIR).  The patient previously received the first dose of bnt162b2 on 31Dec2020 09:30 in left arm(lot number: EL0142) for COVID-19 immunization. The patient experienced hives on face and neck worsening to stridorous breath sounds on 22Jan2021 12:00. The outcome of the events was recovering.  The event resulted in an emergency room/department or urgent care.  Treatment included Epinephrine, Benadryl, Prednisone. The patient did not have CVOID-prior to vaccination and was not tested for COVID-19 post vaccination.; Sender's Comments: Based on currently known drug safety profile, a causal association between the reported events hives on face and neck worsening to stridorous breath sounds and bnt162b2 cannot be excluded. The patient's underlying risk factors/predisposing condition asthma is considered as a risk factor to develop the event stridorous breath sounds.  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: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, SARS-CoV-2 test
Clinical narrative: soreness returned to both quads again/ entire right quad was sore and then it settled proximal & lateral; This is a spontaneous report from a contactable other healthcare professional (patient). A 56-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number CZ3302), via an unspecified route of administration (left arm), on 20Jan2021, at a single dose, for covid-19 immunization. Medical history included GERD, osteoarthritis, spinal stenosis, allergies: penicillin, covid prior vaccination, and covid-tested post vaccination of the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via nasal swab PCR and Rapid tests on 06Jan2021 with results of negative. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number ELO140) on 30Dec2020 14:00 intramuscularly on the left arm for covid-19 immunization at the age of 55 years and experienced on 31Dec2020 08:00 waking up with muscle soreness in both quads (4/10 pain) that lasted for 24 hours in the left and since 31Dec2020, still having in the right quad - initially it was the entire muscle and then it settles proximal and lateral to hip - the pain level was 2/10. The vaccine was received at the nursing home/senior living facility. The patient's concomitant medications were not reported. The patient stated that after the 2nd dose, on 20Jan2021 the soreness returned to both quads again. Today, 25Jan2021, it continued in right. The patient woke up and the entire right quad was sore and then it settled proximal & lateral. The outcome of the adverse event was unknown. The patient had no other vaccines in four weeks.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Shoulder soreness; This is a spontaneous report from a contactable healthcare professional (patient). A 30-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EK4176; Expiration date was not reported) on 07Jan2021 at a single dose on the right arm, with route of administration unspecified, for COVID-19 immunization at the workplace clinic. The patient had no relevant medical history. The patient's concomitant medications were not reported. The patient had previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EH9899; Expiration date was not reported), intramuscularly on the left arm on 16Dec2020 (when the patient was 30 years old) for COVID-19 immunization. On 07Jan2021, the patient had shoulder soreness. The patient did not receive any treatment for the event. The outcome of the event, shoulder soreness, was recovered on 09Jan2021. The patient was not diagnosed with COVID-19 prior to vaccination, and had not been tested since the vaccination.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Area where injection happened was sore the next day; This is a spontaneous report from a contactable consumer.  A 42-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in the left arm on 25Jan2021, at 10:30 as single dose for covid-19 immunization.  Medical history was reported as none. The patient's concomitant medications were not reported. No allergies to medications, food, or other products were noted.  The patient experienced area where injection happened was sore the next day on 26Jan2021, which was non-serious.  No other vaccines were received within 4 weeks prior to the COVID vaccine. The outcome of event was recovering without treatment. Prior to vaccination, the patient was not  diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. The outcome of area where injection happened was sore the next day was recovering.    No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: chills; general body aches; fatigue; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received first single dose of BNT162B2 (Solution for injection, lot number: el9262, exp date not reported), via an unspecified route of administration (Vaccine location: Left arm) on 22Jan2021 15:00 for COVID-19 immunization. Facility where the most recent COVID-19 vaccine was administered: Other (not specified). Prior to vaccination, the patient was diagnosed with COVID-19. The patient was not pregnant at the time of vaccination and was not pregnant at the time of reporting. The patient had no allergies to medications, food, or other products. There were other medications patient received within 2 weeks of vaccination (not specified). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Jan2021, the patient experienced severe chills lasting for another 24 hrs; then general body aches and fatigue lasting for 3 days. The events were considered as non-serious by the reporter. No treatment was received for the adverse events. Since the vaccination, the patient has not been tested for COVID-19. The patient recovered from the events on an unspecified date in Jan2021.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Loss of personal independence in daily activities
Clinical narrative: to not being able to get from his bed to the bathroom without help/to not being able to manage a phone call; From walking from one end of that enormous facility several times, to not being able to get from his bed to the bathroom without help; This is a spontaneous report from a contactable consumer (patient). An 85-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration in Left arm on 05Jan2021 at 03:00 PM as a single dose, for COVID-19 immunization, lot number: unknown. Medical history was not provided. Patient had no allergies to medications, food, or other products. Prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications in two weeks prior to the vaccination included amlodipine besylate, finasteride, hydrochlorothiazide. Patient did not receive other vaccine in four weeks prior to the COVID vaccine. On 08Jan2021 at 08:00 AM (3 days after the vaccine) patient experienced a drastic decline. From walking from one end of that enormous facility several times, to not being able to get from his bed to the bathroom without help. From still driving his own car, to not being able to manage a phone call. Events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown if patient was treated for the events. Since the vaccination patient had not been tested for COVID-19. Outcome of the events was unknown.  Information on the lot/batch number has been requested.