chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Rash, Rash erythematous
Clinical narrative: face and next rash, app. 15 minutes post injection; heat in face; flat red rash on forehead, cheeks, nose, chin, neck; This is a spontaneous report from a contactable consumer (patient).  A 58-year-old non pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EN6199, expiration date was not reported), via an unspecified route of administration, administered in left arm on 23Mar2021 13:30 (at the age of 58-years-old) as dose 1, single for covid-19 immunization at hospital. The patient medical history included fibromyalgia, hypothyroidism, CFS, osteoarthritis, asthma, known_allergies: morphine, known_allergies: tree pollens, known_allergies: drinking alcohol. The patient was allergic to morphine, tree pollens, drinking alcohol. Concomitant medications included benazepril, zolpidem, fluticasone propionate, salmeterol xinafoate (ADVAIR), levothyroxine, liothyronine (NP THYROID), bupropion hydrochloride (WELLBUTRIN), all taken for unknown indications from an unknown date. List of other medications the patient received within 2 weeks of vaccination included Benazapril, Zolpidem, Advair, NP Thyroid, Wellbutr. 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 has not been tested for COVID-19. It was reported that, on 23Mar2021 at 01:45 AM the patient experienced face and next rash, app. 15 minutes post injection, no throat swelling, heat in face, flat red rash on forehead, cheeks, nose, chin, neck. No treatment was received for the adverse event. The reporter assessed the seriousness as non-serious. The outcome of the events was recovered on an unspecified date of 2021.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea, Illness
Clinical narrative: sickness for 48 hours; my system is totally aired out; This is a spontaneous report from a contactable consumer or other non hcp (patient) received from Pfizer RxPathways. A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date the patient experienced sickness for 48 hours, my system is totally aired out. Verbatim and Event Description: Phone call received from the patient regarding Pfizer-BioNTech COVID-19 Vaccine. During the call, the patient stated After first dose my system is totally aired out, miserable, sickness for 48 hours after first dose. Date the event description was reported: 23MAR2021. Outcome of the events was unknown.   Information on the lot/batch number has been requested.  Follow-up (06Apr2021): Follow-up attempts are completed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Axillary arm pain on side of administration of second dose; Itchy on arms and side; This is a spontaneous report from a contactable other hcp (patient). A 41-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 25Mar2021 at 09:15 AM (at the age of 41-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient had no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications received within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm left on 04Mar2021 at 09:15 AM as dose 1, single for COVID-19 immunization and experienced diarrhea. On an unspecified date in Mar2021, the patient experienced axillary arm pain on side of administration of second dose, itchy on arms and side. Verbatim and Event description: axillary arm pain on side of administration of second dose, itchy on arms and side. First dose diarrhea. The patient did not receive treatment for the events. Outcome of the events was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Lethargy, Pain in extremity, Pyrexia
Clinical narrative: Upper arm soreness; intense headache; fever; general feeling of lethargy and a feeling of being spaced out; This is a spontaneous report from a contactable consumer (reported for himself). A 52-years-old male patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: 3248/Batch number was not reported), dose 2 via an unspecified route of administration, administered in arm left on 24Mar2021 at 15:00 (at the age of 52-years-old) as dose 2, single for covid-19 immunisation at Workplace clinic. Medical history included covid-19 from an unknown date and unknown if ongoing (Prior to vaccination, was the patient diagnosed with COVID-19: Yes). The patient concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to the vaccination, the patient has been diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient has no reported allergies. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot/Batch number was not reported), dose 1 via an unspecified route of administration on 03Mar2021 at 15:00 (at the age of 52-years-old) as dose 1, single for covid-19 immunisation at Workplace clinic. On 25Mar2021 at 09:00, the patient experienced upper arm soreness, intense headache, fever and general feeling of lethargy and a feeling of being spaced out. No treatment was given for the events. The outcome of the events was resolved on an unspecified date in 2021.  Follow-up attempts completed. No further information expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Nail discolouration, Pain in extremity
Clinical narrative: Pain in the arm for 2 days; Tightness of chest on 2nd day after 2nd shot; black spot about the size of a pencil eraser appear under his nail; This is a spontaneous report from a contactable consumer. A 60-years-old male patient received bnt162b2 (Formulation: Solution for injection; Batch/Lot Number: EL 3249), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Unknown if had allergies. The patient previously received first dose of bnt162b2 on an unspecified date for covid-19 immunisation. Unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. Unknown if the patient received any other medications within 2 weeks of vaccination. On 11Feb2021 patient experienced Pain in the arm for 2 days.  Tightness of chest on 2nd day after 2nd shot. One week after 2nd dose, patient had black spot about the size of a pencil eraser appear under his nail.  It lasted 3 weeks until an antibiotic was taken. The problem resolves, but nail is weak and fragile. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment with doxycycline 100mg. Prior to vaccination, unknown if the patient diagnosed with COVID-19. Since the vaccination, unknown if the patient has been tested for COVID-19. The outcome of the events was recovered with sequelae.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Headache, Pain in extremity
Clinical narrative: Sore arm, headache, brain fog; Sore arm, headache, brain fog; Sore arm, headache, brain fog; This is a spontaneous report from non-contactable consumer (patient). A 36-years-old male patient received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: not reported), dose 1 via unspecified route of administration in the arm left on 23Mar2021 at 9:00AM as DOSE 1, SINGLE for covid-19 immunization (at age of 36 years) at hospital. The patient medical history and concomitant medications were not reported. The patient had not any known history of allergies to food medications, food, or other products. The patient had not diagnosed with COVID-19 prior to vaccination and patient not been tested for COVID-19, since the vaccination. It was reported that patient did not take any vaccine within 4 weeks prior to Covid vaccine. On 23 Mar2021,at 11:00AM the patient had experienced sore arm, headache and brain fog. The patient did not received any treatment for the adverse event. The patient was not hospitalised. The outcome of the events was recovered in 2021.     No follow up attempts are possible; information about lot number/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Inflammation, Rash pruritic, Skin exfoliation
Clinical narrative: I received the vaccine 3/24/21 around 3:45pm. I had a soar arm which was expected but then I woke up on 3/26/21 at 7am with a hot, bright red and itchy rash under my breasts and between them. The skin; I received the vaccine 3/24/21 around 3:45pm. I had a soar arm which was expected but then I woke up on 3/26/21 at 7am with a hot, bright red and itchy rash under my breasts and between them. The skin; I received the vaccine 3/24/21 around 3:45pm. I had a soar arm which was expected but then I woke up on 3/26/21 at 7am with a hot, bright red and itchy rash under my breasts and between them. The skin; The skin was red and peeling/flaking; This is a spontaneous report from a contactable other hcp (patient). A 26-year-old non pregnant female patient received first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: ER8733), via an unspecified route of administration, administered in Arm Right on 24Mar2021 (age at the vaccination 26-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received Vitamin D3 and birth Control medication within 2 weeks of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. patient received the vaccine on 24Mar2021 around 3:45pm. she had a soar arm which was expected but then she woke up on 26Mar2021 at 7am with a hot, bright red and itchy rash under her breasts and between them. The skin was red and peeling/flaking. Anything touching it caused irritation ie skin, fabrics. The patient did not receive any other treatment for the events. The outcome of the events was not recovered.  No follow-up attempts are possible; Information related to batch/lot number could not be requested.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Chills, Dizziness, Hypoaesthesia
Clinical narrative: I immediately had dizziness and felt weak and nauseous. 5 minutes later the roof of my mouth started numbing and my left arm started hurting. I waited 30 min before leaving the pharmacy. Next day I h; I immediately had dizziness and felt weak and nauseous. 5 minutes later the roof of my mouth started numbing and my left arm started hurting. I waited 30 min before leaving the pharmacy. Next day I h; I immediately had dizziness and felt weak and nauseous. 5 minutes later the roof of my mouth started numbing and my left arm started hurting. I waited 30 min before leaving the pharmacy. Next day I h; I immediately had dizziness and felt weak and nauseous. 5 minutes later the roof of my mouth started numbing and my left arm started hurting. I waited 30 min before leaving the pharmacy. Next day I h; severe pain in my arm; Chills and fever.; Chills and fever.; Panic attack due to severe anxiety; Panic attack due to severe anxiety; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6204 6/21), via an unspecified route of administration in arm left on 18Mar2021 (at the age of 26-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history and concurrent conditions were reported as none. The patient's concomitant medications received within 2 weeks of vaccination included Vitamin C, Tylenol. It was reported that, the patient was not pregnant at time of vaccination. Allergies to medications, food or other products was reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On 18Mar2021 at 16:00, the patient immediately had dizziness and felt weak and nauseous. 5 minutes later the roof of her mouth started numbing and her left arm started hurting. Stated that, she waited 30 min before leaving the pharmacy. Stated that, next day, had severe pain in her arm. Chills and fever. A panic attack due to severe anxiety that lasted about an hour. Treatment received for the events included self-treated with Tylenol, Theraflu and Aspirin. The outcome of the events was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity, Panic attack, Pyrexia
Clinical narrative: I immediately had dizziness and felt weak and nauseous. 5 minutes later the roof of my mouth started numbing and my left arm started hurting. I waited 30 min before leaving the pharmacy. Next day I h; I immediately had dizziness and felt weak and nauseous. 5 minutes later the roof of my mouth started numbing and my left arm started hurting. I waited 30 min before leaving the pharmacy. Next day I h; I immediately had dizziness and felt weak and nauseous. 5 minutes later the roof of my mouth started numbing and my left arm started hurting. I waited 30 min before leaving the pharmacy. Next day I h; I immediately had dizziness and felt weak and nauseous. 5 minutes later the roof of my mouth started numbing and my left arm started hurting. I waited 30 min before leaving the pharmacy. Next day I h; severe pain in my arm; Chills and fever.; Chills and fever.; Panic attack due to severe anxiety; Panic attack due to severe anxiety; This is a spontaneous report from a contactable consumer (patient). A 26-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6204 6/21), via an unspecified route of administration in arm left on 18Mar2021 (at the age of 26-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history and concurrent conditions were reported as none. The patient's concomitant medications received within 2 weeks of vaccination included Vitamin C, Tylenol. It was reported that, the patient was not pregnant at time of vaccination. Allergies to medications, food or other products was reported as no. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On 18Mar2021 at 16:00, the patient immediately had dizziness and felt weak and nauseous. 5 minutes later the roof of her mouth started numbing and her left arm started hurting. Stated that, she waited 30 min before leaving the pharmacy. Stated that, next day, had severe pain in her arm. Chills and fever. A panic attack due to severe anxiety that lasted about an hour. Treatment received for the events included self-treated with Tylenol, Theraflu and Aspirin. The outcome of the events was recovered on an unspecified date in 2021.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Rash, Vaccination site pain
Clinical narrative: Extreme exhaustion; chills; minor rash; sore at injection site; dizziness; mild bump at injection site; This is a spontaneous report from a contactable consumer. A 19-Year-old female patient received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: En6201, Expiration date: Unknown, Solution for injection), on 17Mar2021 around 12:00 PM on left Arm as Dose 1 single for covid 19 immunization (age at vaccination:19-Year-old). Medical history was reported as unknown. Concomitant medications included Pantoprazole, Junelfe within 2 weeks. Other medications in two weeks included Multivitamin and Probiotic medications. The patient had not received any other vaccine in four weeks. The patient had not affected with covid19 before or after vaccination. On 17Mar2021 around 01:30 PM patient experienced Extreme exhaustion, chills, minor rash, sore at injection site, dizziness and mild bump at injection site. It was reported that patient was not pregnant at the time of vaccination. The patient had not involved in any prolonged hospitalisation. No therapeutic treatments were received. On an unspecified date the outcome of the events was reported as recovering/resolving.   Follow-up attempts completed. No further information expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: Extreme exhaustion; chills; minor rash; sore at injection site; dizziness; mild bump at injection site; This is a spontaneous report from a contactable consumer. A 19-Year-old female patient received Pfizer Covid 19 (BNT162B2) (Batch/Lot number: En6201, Expiration date: Unknown, Solution for injection), on 17Mar2021 around 12:00 PM on left Arm as Dose 1 single for covid 19 immunization (age at vaccination:19-Year-old). Medical history was reported as unknown. Concomitant medications included Pantoprazole, Junelfe within 2 weeks. Other medications in two weeks included Multivitamin and Probiotic medications. The patient had not received any other vaccine in four weeks. The patient had not affected with covid19 before or after vaccination. On 17Mar2021 around 01:30 PM patient experienced Extreme exhaustion, chills, minor rash, sore at injection site, dizziness and mild bump at injection site. It was reported that patient was not pregnant at the time of vaccination. The patient had not involved in any prolonged hospitalisation. No therapeutic treatments were received. On an unspecified date the outcome of the events was reported as recovering/resolving.   Follow-up attempts completed. No further information expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass, Limb discomfort
Clinical narrative: Mine is still red all the way across my arm and hot to the touch; Underneath it had a lump; I would say it was as big as a baseball but now today it is down to about the size of a golf ball/lump as big as the size of a baseball, swelled up; This is a spontaneous report received from a contactable consumer or other non hcp. A 72-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: EL9265) via an unspecified route of administration in Arm Left on an unspecified date (age at vaccination 72years old) as single dose for covid-19 immunisation. Medical history included diabetes mellitus, pernicious anaemia, vitamin k deficiency, hyperparathyroidism, all from an unknown date and unknown if ongoing. The patient experienced mine is still red all the way across my arm and hot to the touch, underneath it had a lump; i would say it was as big as a baseball but now today it is down to about the size of a golf ball/lump as big as the size of a baseball, swelled up on an unspecified date. The clinical course was reported as I got my Pfizer Covid shot Thursday the 18th and I read what the possible side effects would be and one of them is possible that there could be a little bit of swelling and redness but mine is still red all the way across my arm and hot to the touch and underneath it, it had a lump, I would say it was as big as a baseball but now today it is down to about the size of a golf ball and it's been 6 days. When paraphrased the concern, Consumer stated, "It was my 2nd shot. It didn't start the very 1st day. It started the next day and it had a lump up until yesterday and it had lump as big as the size of a baseball, swelled up you could see it just by looking at it. Now today it is still red and hot but now it about the size of a golf ball. The patient received treatment for events with Tylenol. The clinical outcome of the event mine is still red all the way across my arm and hot to the touch was not recovered and other event was recovering. Therapeutic measures were taken as a result of mine is still red all the way across my arm and hot to the touch (limb discomfort), underneath it had a lump; i would say it was as big as a baseball but now today it is down to about the size of a golf ball/lump as big as the size of a baseball, swelled up (injection site mass).  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: I felt light headed and had a headache most of the day on the first day that night I developed a slight fever. The day after I was nauseous and exhausted. I was tired for an additional two days but no; I felt light headed and had a headache most of the day on the first day that night I developed a slight fever. The day after I was nauseous and exhausted. I was tired for an additional two days but no; I felt light headed and had a headache most of the day on the first day that night I developed a slight fever. The day after I was nauseous and exhausted. I was tired for an additional two days but no; I felt light headed and had a headache most of the day on the first day that night I developed a slight fever. The day after I was nauseous and exhausted. I was tired for an additional two days but no; I felt light headed and had a headache most of the day on the first day that night I developed a slight fever. The day after I was nauseous and exhausted. I was tired for an additional two days but no; I was tired for an additional two days but nothing too extreme there; This is a follow up spontaneous report received from a contactable consumer (patient ). This is a 34-years old non pregnant female consumer received bnt162b2 (COMIRNATY, Solution for injection, Lot Number: unknown), dose 1 on an unspecified route on 11Mar2021 10:00 AM as DOSE 1, SINGLE in left arm for covid-19 immunization (at age of 34 years)at health vaccination centre in movie theatre. The patient medical history included Undefined connective tissue disorder and fibromyalgia. The patient concomitant medications included : Hydroxychloroquine, levothyroxine (LEVOTHYROXINE SODIUM), bupropion xl, bc within 2 weeks of vaccination. It was reported that patient did not take any vaccine within 4 weeks prior to Covid vaccine. The patient had not diagnosed with COVID-19 prior to vaccination and patient not been tested for COVID-19, since the vaccination and no allergies to medications, food, or other products. On 11Mar2021 at 11:30 AM the patient had experienced I felt lightheaded and had a headache most of the day on the first day that night and developed a slight fever. The day after She was nauseous and exhausted. She was tired for an additional two days but nothing too extreme there. The patient did not received any treatment for the adverse events. The outcome of the events were recovered.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood test, Fatigue, Gait inability
Clinical narrative: Continued chronic joint pain, shoulders, left more than right, hip pain/weakness, hand, finger joints, stiff / sore.  Chronic hip / shoulder weakness.  General malaise, tired, feverish, arm pain for 2; Continued chronic joint pain, shoulders, left more than right, hip pain/weakness, hand, finger joints, stiff / sore.  Chronic hip / shoulder weakness.  General malaise, tired, feverish, arm pain for 2; Continued chronic joint pain, shoulders, left more than right, hip pain/weakness, hand, finger joints, stiff / sore.  Chronic hip / shoulder weakness.  General malaise, tired, feverish, arm pain for 2; General malaise; tired; feverish; arm pain; not being able to walk down a flight of stairs without her hips giving out with a loose painful, weakness; Extended worsening chronic painful left shoulder, muscle, arm pain; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 54 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK4176) via an unspecified route, administered in Arm Left on 26Jan2021 at 12:00 (54-year-old at vaccination) as a Dose 2, Single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included asthma, allergic to Sulfa drug, Sumatriptan. The patient's concomitant medications included albuterol sulfate inhaler within 2 weeks of vaccination. The patient previously took sumatriptan, sulfa drug and experienced allergy. The most recent COVID-19 vaccine facility was administered was reported as Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccine within four weeks prior to vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK4176) via an unspecified route of administration in Right arm on 09Jan2021 at 20:00 (54-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. On 26Jan2021 at 12:00, the patient had experienced continued chronic joint pain, shoulders, left more than right, hip pain/weakness, hand, finger joints, stiff / sore. Chronic hip / shoulder weakness. General malaise, tired, feverish, arm pain for 2 days post vaccine. Extended worsening chronic painful left shoulder, muscle, arm pain. She was being able to run 2 plus miles and workout to not being able to walk down a flight of stairs without her hips giving out with a loose painful, weakness. It's like it set off a subtle weakness in all her joints. These adverse events resulted the patient to doctor or other healthcare professional office/clinic visit. The patient underwent lab test and procedure which included blood work and imaging: result not reported. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Imaging procedure, Joint stiffness, Malaise, Myalgia, Pain in extremity
Clinical narrative: Continued chronic joint pain, shoulders, left more than right, hip pain/weakness, hand, finger joints, stiff / sore.  Chronic hip / shoulder weakness.  General malaise, tired, feverish, arm pain for 2; Continued chronic joint pain, shoulders, left more than right, hip pain/weakness, hand, finger joints, stiff / sore.  Chronic hip / shoulder weakness.  General malaise, tired, feverish, arm pain for 2; Continued chronic joint pain, shoulders, left more than right, hip pain/weakness, hand, finger joints, stiff / sore.  Chronic hip / shoulder weakness.  General malaise, tired, feverish, arm pain for 2; General malaise; tired; feverish; arm pain; not being able to walk down a flight of stairs without her hips giving out with a loose painful, weakness; Extended worsening chronic painful left shoulder, muscle, arm pain; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 54 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK4176) via an unspecified route, administered in Arm Left on 26Jan2021 at 12:00 (54-year-old at vaccination) as a Dose 2, Single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included asthma, allergic to Sulfa drug, Sumatriptan. The patient's concomitant medications included albuterol sulfate inhaler within 2 weeks of vaccination. The patient previously took sumatriptan, sulfa drug and experienced allergy. The most recent COVID-19 vaccine facility was administered was reported as Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccine within four weeks prior to vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK4176) via an unspecified route of administration in Right arm on 09Jan2021 at 20:00 (54-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. On 26Jan2021 at 12:00, the patient had experienced continued chronic joint pain, shoulders, left more than right, hip pain/weakness, hand, finger joints, stiff / sore. Chronic hip / shoulder weakness. General malaise, tired, feverish, arm pain for 2 days post vaccine. Extended worsening chronic painful left shoulder, muscle, arm pain. She was being able to run 2 plus miles and workout to not being able to walk down a flight of stairs without her hips giving out with a loose painful, weakness. It's like it set off a subtle weakness in all her joints. These adverse events resulted the patient to doctor or other healthcare professional office/clinic visit. The patient underwent lab test and procedure which included blood work and imaging: result not reported. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Continued chronic joint pain, shoulders, left more than right, hip pain/weakness, hand, finger joints, stiff / sore.  Chronic hip / shoulder weakness.  General malaise, tired, feverish, arm pain for 2; Continued chronic joint pain, shoulders, left more than right, hip pain/weakness, hand, finger joints, stiff / sore.  Chronic hip / shoulder weakness.  General malaise, tired, feverish, arm pain for 2; Continued chronic joint pain, shoulders, left more than right, hip pain/weakness, hand, finger joints, stiff / sore.  Chronic hip / shoulder weakness.  General malaise, tired, feverish, arm pain for 2; General malaise; tired; feverish; arm pain; not being able to walk down a flight of stairs without her hips giving out with a loose painful, weakness; Extended worsening chronic painful left shoulder, muscle, arm pain; This is a spontaneous report from a contactable other healthcare professional (patient herself). A 54 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK4176) via an unspecified route, administered in Arm Left on 26Jan2021 at 12:00 (54-year-old at vaccination) as a Dose 2, Single for COVID-19 immunization. The patient was non-pregnant at time of vaccination. The patient's medical history included asthma, allergic to Sulfa drug, Sumatriptan. The patient's concomitant medications included albuterol sulfate inhaler within 2 weeks of vaccination. The patient previously took sumatriptan, sulfa drug and experienced allergy. The most recent COVID-19 vaccine facility was administered was reported as Hospital. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient had not received any other vaccine within four weeks prior to vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EK4176) via an unspecified route of administration in Right arm on 09Jan2021 at 20:00 (54-year-old at vaccination) as a Dose 1, single for COVID-19 immunization. On 26Jan2021 at 12:00, the patient had experienced continued chronic joint pain, shoulders, left more than right, hip pain/weakness, hand, finger joints, stiff / sore. Chronic hip / shoulder weakness. General malaise, tired, feverish, arm pain for 2 days post vaccine. Extended worsening chronic painful left shoulder, muscle, arm pain. She was being able to run 2 plus miles and workout to not being able to walk down a flight of stairs without her hips giving out with a loose painful, weakness. It's like it set off a subtle weakness in all her joints. These adverse events resulted the patient to doctor or other healthcare professional office/clinic visit. The patient underwent lab test and procedure which included blood work and imaging: result not reported. The outcome of the events was not recovered.  Follow-up attempts completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea; vomiting; severe diarrhea; fever; tiredness; This is a spontaneous report from a contactable consumer, the patient. A 43-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: ER8732), via an unspecified route of administration in the arm right on 25Mar2021 15:30 as dose 2, single (at the age of 43-years-old) for covid-19 immunization. Medical history included copd, acid reflux, depression and allergies to medications, food and other products. Concomitant medication included omeprazole. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6199), via an unspecified route of administration in the arm right on 04Mar2021 15:45 as dose 1, single for covid-19 immunization. On 26Mar2021 21:00, the patient experienced nausea, vomiting, severe diarrhea, fever and tiredness. The patient did not receive any treatment for the events. The patient did not diagnose with COVID-19 prior to vaccination and since the vaccination, the patient did not test for COVID-19. The outcome of the events was not recovered.  No follow-up attempts were possible; information about lot/batch number could not be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Cough, Dysgeusia, Pain in extremity, Parosmia
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 31-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: BIN - 201), via an unspecified route of administration (at the age of 31-years), administered in arm left on 25Mar2021 at 12:00 as dose 1, single for COVID-19 immunization. Medical history included covid-19 and none from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The most recent COVID-19 vaccine was administered in pharmacy or drug store. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unspecified date, the patient experienced terrible smell with most all foods, terrible taste similar to the smell. On 28Mar2021, experienced sore arm moving into armpit and cough. It was further stated that terrible smell with most all foods lingering terrible taste similar to the smell , sore arm moving into armpit day 3, day 3 feels like I am beginning to get a cough. The treatment was not received for all the events. The clinical outcome for the events was reported as not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Dyspnoea exertional, Heart rate, Heart rate increased
Clinical narrative: began to have difficulty breathing ONLY with activity; Elevated BP and HR accompanied; Elevated BP and HR accompanied; This is a spontaneous report from a contactable consumer (patient). A 29-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP7534, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 21Mar2021 at 12:30 hours as dose 1, single for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) from an unknown date and unknown if ongoing and childhood asthma from an unknown date to unknown date. Concomitant medication(s) received within 2 weeks of vaccination included nabumetone, desogestrel, ethinylestradiol (Isibloom), mentha x piperita oil (Ibgard); D-mannose, vaccinium oxycoccos (Dmannosa) and cranberry (all taken for an unspecified indication, start and stop date were not reported). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no allergies to medications, food, or other products. Patient was not diagnosed with COVID-19, prior to vaccination. On 22Mar2021, at 07:45 hours, following Monday, patient had difficulty breathing only with activity. Patient had asthma as a child, went away with adulthood. Elevated blood pressure (BP) and Heart rate (HR) was accompanied. Patient had doctor or other healthcare professional office/clinic visit for the events. On 24Mar2021, patient had been tested for the COVID-19 by nasal swab and result was negative. Therapeutic measures were taken as a result of all the events and treatment included albuterol inhaler. All the events were reported as non-serious by the patient. The outcome of all the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: began to have difficulty breathing ONLY with activity; Elevated BP and HR accompanied; Elevated BP and HR accompanied; This is a spontaneous report from a contactable consumer (patient). A 29-years-old non-pregnant female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EP7534, Expiration date was not reported), via an unspecified route of administration, administered in left arm on 21Mar2021 at 12:30 hours as dose 1, single for COVID-19 immunisation. Medical history included irritable bowel syndrome (IBS) from an unknown date and unknown if ongoing and childhood asthma from an unknown date to unknown date. Concomitant medication(s) received within 2 weeks of vaccination included nabumetone, desogestrel, ethinylestradiol (Isibloom), mentha x piperita oil (Ibgard); D-mannose, vaccinium oxycoccos (Dmannosa) and cranberry (all taken for an unspecified indication, start and stop date were not reported). Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient had no allergies to medications, food, or other products. Patient was not diagnosed with COVID-19, prior to vaccination. On 22Mar2021, at 07:45 hours, following Monday, patient had difficulty breathing only with activity. Patient had asthma as a child, went away with adulthood. Elevated blood pressure (BP) and Heart rate (HR) was accompanied. Patient had doctor or other healthcare professional office/clinic visit for the events. On 24Mar2021, patient had been tested for the COVID-19 by nasal swab and result was negative. Therapeutic measures were taken as a result of all the events and treatment included albuterol inhaler. All the events were reported as non-serious by the patient. The outcome of all the events was recovering.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Blood test, Chest pain, Dyspnoea
Clinical narrative: developing weakness on my back; developing mucous in the back; severe breathing, like shortness of breath; pains underneath my chest or the heart; pain on my back; This is a spontaneous report received from a contactable consumer (Patient). This 71-year-old patient reported for own-self.  A 71-year-old patient with unspecified gender received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered on Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history includes Large intestine benign neoplasm, Visual impairment and vision problems after an accident from an unspecified date to unknown date and concomitant medications were not reported. In Mar2021, after the vaccination, the patient experienced pain underneath his chest or the heart. Patient had pain on his back and had severe breathing, like shortness of breath and developing weakness over back. Patient is also experiencing mucous development over the back but patient cough it out and blow out from his nose. right now, patient is feeling like there is mucous coming into his back. Also, weakness over the back. Its almost 3 weeks now and patient scared to take the second dose. The events assessed as non-serious. The patient lab data includes blood test with unknown results on an unspecified date. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (17May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Secretion discharge
Clinical narrative: developing weakness on my back; developing mucous in the back; severe breathing, like shortness of breath; pains underneath my chest or the heart; pain on my back; This is a spontaneous report received from a contactable consumer (Patient). This 71-year-old patient reported for own-self.  A 71-year-old patient with unspecified gender received a dose of BNT162B2 (BNT162B2, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via intramuscular, administered on Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history includes Large intestine benign neoplasm, Visual impairment and vision problems after an accident from an unspecified date to unknown date and concomitant medications were not reported. In Mar2021, after the vaccination, the patient experienced pain underneath his chest or the heart. Patient had pain on his back and had severe breathing, like shortness of breath and developing weakness over back. Patient is also experiencing mucous development over the back but patient cough it out and blow out from his nose. right now, patient is feeling like there is mucous coming into his back. Also, weakness over the back. Its almost 3 weeks now and patient scared to take the second dose. The events assessed as non-serious. The patient lab data includes blood test with unknown results on an unspecified date. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.  Follow-up (PRD/SRD (17May2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Flushing, Liver function test
Clinical narrative: Blood pressure spiked; I flush every day; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 60-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6207; Expiration Date: 31Jul2021), via an unspecified route of administration on 16Mar2021 (at the age of 60-years-old) as dose number unknown, single for covid-19 immunisation. The patient's medical history included rheumatoid arthritis. The patient's concomitant medication(s) included etanercept (ENBREL) and unspecified vitamin supplement. The patient stated on the 16Mar2021 of this month, he got his shot and 2 days after on 18Mar2021 10:00 he got it his blood pressure spiked to 168/105 and he got real flushed and since then his blood pressure has hung in there in the 140's 150's over 80's over 90's. He flush every day and he want to know if there was, he had read out and he cannot see anywhere where it says blood pressure. It could be a side effect. He was kind of concerned with this. Laboratory work: he stated, "Yes, he actually did, just like a month because he goes like every 6 months to go and check his liver function and while on the Enbrel he has to take. He has to do it twice a year, but he did it like a month ago." He stated event started two days later so, it was like 48 hours later almost exact because he had my appointment at 10 and he woke up and he felt flushed and took his blood pressure it was like 160/105. Treatment: he stated, "No, he had called his doctor and they have told me to call you guys to see if there have been any side effects. Really, he has done nothing. He eat clean. He was a vegetarian. So, his blood pressure has always been right around 120's/70's." The patient required physician office visit. The patient not received treatment for the event. The outcome of the events was unknown.   No follow-up attempts are possible; no further information expected.