chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Bone pain, Chills, Fatigue
Clinical narrative: Soreness on the injection site; Body aches/ Severe bone aching from head to toe/ too painful to even move my legs or hands; Body aches/ Severe bone aching from head to toe/ too painful to even move my legs or hands; Severe Headache; Fatigue; Body aches/ Severe bone aching from head to toe/ too painful to even move my legs or hands; Chills; Fever of 98.7 F; Body aches; Sweating; This is a spontaneous report from a contactable other hcp (Nurse, the patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3248), via an unspecified route of administration, administered in Arm Left on 17Mar2021 10:45 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 24Feb2021 as dose 1, single for COVID-19 immunisation and experienced no adverse events. The patient experienced body aches on and sweating on 17Mar2021 15:00; severe headache, fatigue, body aches/ severe bone aching from head to toe/ too painful to even move my legs or hands, chills and fever of 98.7 F on 18Mar2021, soreness on the injection site on 19Mar2021. It was reported that (18Mar2021) the patient woke up with severe headache, fatigue and body aches. Severe bone aching from head to toe, it was too painful to even move patient's legs or hands. Therapeutic measures were taken, which includes: Theraflu. By noon patient was having chills and fever of 98.7o F. Took Tylenol.  Symptoms all through the night. (19Mar2021): Woke up with no body aches or fever, only soreness on the injection site. The patient underwent lab tests and procedures which included body temperature: 98.7 F on 18Mar2021. Therapeutic measures taken as a result of the events included Theraflu and Tylenol. The outcome of the events body aches, body aches/ severe bone aching from head to toe/ too painful to even move my legs or hands and fever of 98.7 F were recovered on 19Mar2021, the outcome of other events were unknown.  No follow-up attempts are possible; No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Joint range of motion decreased, Pain, Pyrexia
Clinical narrative: Soreness on the injection site; Body aches/ Severe bone aching from head to toe/ too painful to even move my legs or hands; Body aches/ Severe bone aching from head to toe/ too painful to even move my legs or hands; Severe Headache; Fatigue; Body aches/ Severe bone aching from head to toe/ too painful to even move my legs or hands; Chills; Fever of 98.7 F; Body aches; Sweating; This is a spontaneous report from a contactable other hcp (Nurse, the patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3248), via an unspecified route of administration, administered in Arm Left on 17Mar2021 10:45 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 24Feb2021 as dose 1, single for COVID-19 immunisation and experienced no adverse events. The patient experienced body aches on and sweating on 17Mar2021 15:00; severe headache, fatigue, body aches/ severe bone aching from head to toe/ too painful to even move my legs or hands, chills and fever of 98.7 F on 18Mar2021, soreness on the injection site on 19Mar2021. It was reported that (18Mar2021) the patient woke up with severe headache, fatigue and body aches. Severe bone aching from head to toe, it was too painful to even move patient's legs or hands. Therapeutic measures were taken, which includes: Theraflu. By noon patient was having chills and fever of 98.7o F. Took Tylenol.  Symptoms all through the night. (19Mar2021): Woke up with no body aches or fever, only soreness on the injection site. The patient underwent lab tests and procedures which included body temperature: 98.7 F on 18Mar2021. Therapeutic measures taken as a result of the events included Theraflu and Tylenol. The outcome of the events body aches, body aches/ severe bone aching from head to toe/ too painful to even move my legs or hands and fever of 98.7 F were recovered on 19Mar2021, the outcome of other events were unknown.  No follow-up attempts are possible; No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness on the injection site; Body aches/ Severe bone aching from head to toe/ too painful to even move my legs or hands; Body aches/ Severe bone aching from head to toe/ too painful to even move my legs or hands; Severe Headache; Fatigue; Body aches/ Severe bone aching from head to toe/ too painful to even move my legs or hands; Chills; Fever of 98.7 F; Body aches; Sweating; This is a spontaneous report from a contactable other hcp (Nurse, the patient). A patient of unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3248), via an unspecified route of administration, administered in Arm Left on 17Mar2021 10:45 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL3247) via an unspecified route of administration, administered in Arm Left on 24Feb2021 as dose 1, single for COVID-19 immunisation and experienced no adverse events. The patient experienced body aches on and sweating on 17Mar2021 15:00; severe headache, fatigue, body aches/ severe bone aching from head to toe/ too painful to even move my legs or hands, chills and fever of 98.7 F on 18Mar2021, soreness on the injection site on 19Mar2021. It was reported that (18Mar2021) the patient woke up with severe headache, fatigue and body aches. Severe bone aching from head to toe, it was too painful to even move patient's legs or hands. Therapeutic measures were taken, which includes: Theraflu. By noon patient was having chills and fever of 98.7o F. Took Tylenol.  Symptoms all through the night. (19Mar2021): Woke up with no body aches or fever, only soreness on the injection site. The patient underwent lab tests and procedures which included body temperature: 98.7 F on 18Mar2021. Therapeutic measures taken as a result of the events included Theraflu and Tylenol. The outcome of the events body aches, body aches/ severe bone aching from head to toe/ too painful to even move my legs or hands and fever of 98.7 F were recovered on 19Mar2021, the outcome of other events were unknown.  No follow-up attempts are possible; No further information expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Insomnia
Clinical narrative: Massive headache; Fatigue; sore muscles; Slight fever (99.8); Chills that were so bad that I could not drink out of a water bottle; woke up feeling sore and couldn't get back to sleep/ general body aches; woke up feeling sore and couldn't get back to sleep; Slight nausea; This is a spontaneous report received from a contactable consumer (patient). This is the first of two reports. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3277) via an unspecified route of administration in right arm on 22Mar2021 at 12:00, (at the age of 37 years) as dose 2, single, for COVID-19 immunisation. Medical history included depression and COVID-19 on unknown dates. The patient had no allergies to medications, food, or other products. The patient received bupropion hydrochloride (WELLBUTRIN) for an unknown indication on unknown dates in two weeks of vaccination. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration on left arm on 02Mar2021 at 13:45, as a single dose, for COVID-19 immunisation and experienced sore arm and slight fatigue 24hours after vaccination on 03Mar2021. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Post vaccination, the patient had not been tested for COVID-19. On 22Mar2021, about 6 hours after injection, the patient experienced slight nausea. On 23Mar2021 at about 04:00 (16hrs after vaccination) the patient woke up feeling sore and could not get back to sleep. On 23Mar2021 at about 05:00, the patient came down with chills that were so bad that he could not drink out of a water bottle. He put on extra clothes and sat by fire and chills went away in about an hour on 23Mar2021. On 23Mar2021 at 07:00, the patient had massive headache, general body aches, fatigue, sore muscles and slight fever 99.8 (units not specified). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the events. The outcome of event chills was recovered and of other events was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain, Pyrexia
Clinical narrative: Massive headache; Fatigue; sore muscles; Slight fever (99.8); Chills that were so bad that I could not drink out of a water bottle; woke up feeling sore and couldn't get back to sleep/ general body aches; woke up feeling sore and couldn't get back to sleep; Slight nausea; This is a spontaneous report received from a contactable consumer (patient). This is the first of two reports. A 37-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3277) via an unspecified route of administration in right arm on 22Mar2021 at 12:00, (at the age of 37 years) as dose 2, single, for COVID-19 immunisation. Medical history included depression and COVID-19 on unknown dates. The patient had no allergies to medications, food, or other products. The patient received bupropion hydrochloride (WELLBUTRIN) for an unknown indication on unknown dates in two weeks of vaccination. The patient previously received her first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL3247) via an unspecified route of administration on left arm on 02Mar2021 at 13:45, as a single dose, for COVID-19 immunisation and experienced sore arm and slight fatigue 24hours after vaccination on 03Mar2021. The patient had not received any other vaccines within 4 weeks prior to the vaccine. Post vaccination, the patient had not been tested for COVID-19. On 22Mar2021, about 6 hours after injection, the patient experienced slight nausea. On 23Mar2021 at about 04:00 (16hrs after vaccination) the patient woke up feeling sore and could not get back to sleep. On 23Mar2021 at about 05:00, the patient came down with chills that were so bad that he could not drink out of a water bottle. He put on extra clothes and sat by fire and chills went away in about an hour on 23Mar2021. On 23Mar2021 at 07:00, the patient had massive headache, general body aches, fatigue, sore muscles and slight fever 99.8 (units not specified). The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. No treatment was received for the events. The outcome of event chills was recovered and of other events was recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: UNK
Symptoms: Abdominal distension, Discomfort, Pharyngeal swelling, Swelling face
Clinical narrative: There is interaction with Plavix; I felt like I had a gumball on my jaw with my cheek and that felt real heavy; My tongue filled up the whole roof my mouth; I had cloudiness like when you get out of the swimming pool, you have a powder around your eyes and I had that; I could not walk; I have fallen numerous times; My legs they feel really heavy; fallen numerous times since the injection; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunization. Patient was also taking clopidogrel bisulfate (PLAVIX), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. On an unspecified date the patient felt like they had a gumball on their jaw with their cheek that felt really heavy. The patient thought their tongue swelled up but that's the throat so maybe that's just the throat, patient doesn't know. All patient knows was that their tongue filled up the whole roof their mouth. Patient had cloudiness described as when you get out of the swimming pool, you have a powder around your eyes. The patient called their family doctor the other day and the doctor asked the patient not to stand out, so the patient didn't get out of the car and stand out. When the patient got home, they could not walk to their front door on their own and their legs are still like that. The patient has fallen numerous times since the injection and it just their legs they feel really heavy and they are just giving down. The other thing is the patients nurse told the patient that there is interaction with Plavix. The patient couldn't put Plavix down because everybody over 50 or 60 at the most are all on blood thinners. Patient did not receive any treatment for the events. Outcome of tongue swelled and cloudiness was not recovered (patient mentioned they are still having this). For the rest of the events, it was unknown.   No follow-up attempts are possible; information about lot/batch cannot be obtained.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Fatigue
Clinical narrative: Heavy Fatigue; Dizziness; Chest tightness; Shortness of breath; This is a spontaneous report received from a contactable consumer (patient). A 46-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 20Mar2021 at 11:00 (at the age of 46 year old) as dose 1, single for COVID-19 immunisation. Medical history included COVID-19. The patient did not have any allergies to food, medications, or other products. Concomitant therapies included turmeric, zinc, omega 3, vitamin D and queracin all for an unspecified date. Prior to vaccination, the patient was diagnosed with COVID-19 and did not receive any other vaccines within 4 weeks. The patient was not pregnant at the time of vaccination. On 20Mar2021 at 14:30, the patient experienced heavy fatigue, dizziness, chest tightness and shortness of breath. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken for the events. The outcome of events heavy fatigue, dizziness, chest tightness and shortness of breath was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate, Heart rate increased, Illness
Clinical narrative: Very sick; Flu like symptoms; fast heartbeat; aching whole body; Slight headache; Strange (no pain) swirling sensation 1/2 hr after shot; fatigue; Slight sore arm; fever; malaise; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EP7534 and expiry date was not reported), via an unspecified route of administration, administered in Arm Right, on 21Mar2021 12:30 (at the age of 62-year-old), as dose 1, single, for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included obesity, BPPV, mild colitis, high BP, high lipids, prediabetes, congestion and COVID in Mar2020. Concomitant medications included bisoprolol (5 mg); atorvastatin (40mg); calcium (600mg); atorvastatin (LIPITOR [ATORVASTATIN]); paracetamol (TYLENOL) taken for nasal congestion.  The patient previously took codeine and experienced itching (sensitivity). Patient was not tested for Covid post vaccination. On 21Mar2021 13:00, the patient experienced strange (no pain) swirling sensation 1/2 hr after shot followed by fatigue. An hour later, the patient experienced flu like symptoms beginning with fast heartbeat and aching whole body, slight headache. The patient also experienced slight sore arm, body aches, fever, malaise and very sick. It was reported that, the patient felt like 50% of original covid 19 symptoms, but was very short lived, (only a few hours). No treatment received for the events.  The patient recovered from slight sore arm, body aches, fever and malaise after 2 days and the outcome for other events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: Very sick; Flu like symptoms; fast heartbeat; aching whole body; Slight headache; Strange (no pain) swirling sensation 1/2 hr after shot; fatigue; Slight sore arm; fever; malaise; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EP7534 and expiry date was not reported), via an unspecified route of administration, administered in Arm Right, on 21Mar2021 12:30 (at the age of 62-year-old), as dose 1, single, for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included obesity, BPPV, mild colitis, high BP, high lipids, prediabetes, congestion and COVID in Mar2020. Concomitant medications included bisoprolol (5 mg); atorvastatin (40mg); calcium (600mg); atorvastatin (LIPITOR [ATORVASTATIN]); paracetamol (TYLENOL) taken for nasal congestion.  The patient previously took codeine and experienced itching (sensitivity). Patient was not tested for Covid post vaccination. On 21Mar2021 13:00, the patient experienced strange (no pain) swirling sensation 1/2 hr after shot followed by fatigue. An hour later, the patient experienced flu like symptoms beginning with fast heartbeat and aching whole body, slight headache. The patient also experienced slight sore arm, body aches, fever, malaise and very sick. It was reported that, the patient felt like 50% of original covid 19 symptoms, but was very short lived, (only a few hours). No treatment received for the events.  The patient recovered from slight sore arm, body aches, fever and malaise after 2 days and the outcome for other events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: Very sick; Flu like symptoms; fast heartbeat; aching whole body; Slight headache; Strange (no pain) swirling sensation 1/2 hr after shot; fatigue; Slight sore arm; fever; malaise; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number EP7534 and expiry date was not reported), via an unspecified route of administration, administered in Arm Right, on 21Mar2021 12:30 (at the age of 62-year-old), as dose 1, single, for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. Medical history included obesity, BPPV, mild colitis, high BP, high lipids, prediabetes, congestion and COVID in Mar2020. Concomitant medications included bisoprolol (5 mg); atorvastatin (40mg); calcium (600mg); atorvastatin (LIPITOR [ATORVASTATIN]); paracetamol (TYLENOL) taken for nasal congestion.  The patient previously took codeine and experienced itching (sensitivity). Patient was not tested for Covid post vaccination. On 21Mar2021 13:00, the patient experienced strange (no pain) swirling sensation 1/2 hr after shot followed by fatigue. An hour later, the patient experienced flu like symptoms beginning with fast heartbeat and aching whole body, slight headache. The patient also experienced slight sore arm, body aches, fever, malaise and very sick. It was reported that, the patient felt like 50% of original covid 19 symptoms, but was very short lived, (only a few hours). No treatment received for the events.  The patient recovered from slight sore arm, body aches, fever and malaise after 2 days and the outcome for other events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Body aches; Mild fever; Chills; This is a spontaneous report from a contactable consumer (patient). A 41-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: UNKNOWN) via an unspecified route of administration on 13Mar2021 15:30 (at the age of 41-year-old) in the left arm, as dose 1, single for COVID-19 immunization. Medical history was not reported. The patient was allergic to meloxicam. The patient did not receive any other vaccines within four weeks prior to COVID-19 vaccination. The patient was not tested for COVID-19, prior to the vaccination. Concomitant medications included atorvastatin (MANUFACTURER UNKNOWN), CENTRUM MULTIVITAMIN started on an unknown date for an unknown indication. The past drug history included meloxicam (MANUFACTURER UNKNOWN) started on unknown date for unknown indication. On 22Mar2021, at 07:00 after 9 days of vaccination, the patient experienced body aches which increased through the day, that night the patient developed mild fever and chills. It lasted one more day and then symptoms disappeared. These events resulted in doctor or other healthcare professional office/clinic visit. On 23Mar2021, the patient underwent a nasal swab and PCR test just to rule out any possibility and the result was negative. TYLENOL (paracetamol) was taken as treatment for the events body aches, mild fever and chills. The clinical outcomes of the events body aches, mild fever and chills were resolved on 23Mar2021 (lasted for one day as reported).  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Eczema, Hypersensitivity, Rash, Skin reaction
Clinical narrative: Developed an allergic reaction;  reaction I had sort of looked like eczema, was a skin reaction; Rash up and down my both legs from my hip to my ankle; Developed an allergic reaction;  reaction I had sort of looked like eczema, was a skin reaction; Developed an allergic reaction;  reaction I had sort of looked like eczema, was a skin reaction; This is a spontaneous report from a contactable consumer or other non hcp. A 68-years-old male patient received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 05Mar2021 as DOSE 1, SINGLE for covid-19 immunisation; bromocriptine mesilate (BROMIDINE), via an unspecified route of administration from an unspecified date (Batch/Lot number was not reported) to an unspecified date, at UNKOWN for glaucoma. Medical history included hypertension from an unknown date and unknown if ongoing, Blood pressure high, blood cholesterol from an unknown date and unknown if ongoing, Cholesterol, glaucoma from an unknown date and unknown if ongoing Verbatim: Glaucoma. Concomitant medications included losartan (LOSARTAN) taken 100 mg for hypertension, start and stop date were not reported; rosuvastatin (ROSUVASTATIN) taken 10 mg for blood cholesterol, start and stop date were not reported; nebivolol hydrochloride (BYSTOLIC) taken 5mg for an unspecified indication, start and stop date were not reported; timolol (TIMOLOL) 2mg,  Brimonidine taken Two mg for glaucoma, start and stop date were not reported. The patient experienced developed an allergic reaction; reaction I had sort of looked like eczema, was a skin reaction on 05Mar2021 with outcome of unknown, rash up and down my both legs from my hip to my ankle on 05Mar2021 with outcome of unknown, developed an allergic reaction;  reaction i had sort of looked like eczema, was a skin reaction on 05Mar2021 with outcome of unknown , developed an allergic reaction;  reaction i had sort of looked like eczema, was a skin reaction on 05Mar2021 with outcome of unknown, rash up and down my both legs from my hip to my ankle on 05Mar2021 with outcome of unknown, rash up and down my both legs from my hip to my ankle on 05Mar2021 with outcome of unknown. Therapeutic measures were taken as a result the events. Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Headache, Lymphadenopathy, Pain
Clinical narrative: wheezing; Entire body aches; coughing; lymph nodes in the left arm out are swollen; head hurts; Exhausted; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, in the right arm on 22Mar2021 at 18:15 (at the age of 47-year-old) as dose 1, single  for COVID-19 immunization. Medical history included COVID-19. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021 at 07:00, the patient's lymph nodes in her left arm out were swollen. The patient had entire body aches. The patient was wheezing and coughing. Her head was hurting and was exhausted. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events . The outcome of the events was not recovered at the time of the report..   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: wheezing; Entire body aches; coughing; lymph nodes in the left arm out are swollen; head hurts; Exhausted; This is a spontaneous report from a contactable consumer (patient). A 47-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, in the right arm on 22Mar2021 at 18:15 (at the age of 47-year-old) as dose 1, single  for COVID-19 immunization. Medical history included COVID-19. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other medications within two weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 23Mar2021 at 07:00, the patient's lymph nodes in her left arm out were swollen. The patient had entire body aches. The patient was wheezing and coughing. Her head was hurting and was exhausted. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events . The outcome of the events was not recovered at the time of the report..   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: itchy rash on left shin and calf; After second dose, rash continued in these areas and spread to left forearmand hand, right hand, behind bothknees, chest, lower back; This is a spontaneous report from a consumer (patient). A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EN6199) via an unspecified route of administration in the left arm on 11Mar2021 at 09:45 (at the age of 65-year-old) as dose 2, single for COVID 19 immunisation. Medical history included hypertension and fibromyalgia. Concomitant medication included atenolol, simvastatin and diphenhydramine Hydrochloride, all for an unknown indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; lot number: EL9269) via an unspecified route of administration in the left arm on 15Feb2021 at 09:45 (at the age of 65-year-old) as single dose for COVID 19 immunisation and experienced diffuse bumpy intensely itchy rash on left shin and calf where her rash continued to spread right leg. The patient had history of allergy to erythromycin. Prior to the vaccination,the patient was not diagnosed with COVID-19 and did not receive any other vaccine within four weeks. The patient was not pregnant at the time of vaccination. After taking the second dose, on an unspecified date in Mar2021, the patient had experienced itchy rash on left shin and calf and spread to left forearm and hand, right hand, behind both knees, chest, lower back. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient was not tested positive for COVID-19 since the vaccination. Therapeutic measures in response to the events included, topical and oral steroids. The outcome of the events was not resolved at the time of report.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 70-year-old male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# EN6204), at  the age of 70, via an unspecified route of administration, left arm, on Mar 3, 2021, at 12:30, single dose, for COVID-19 immunisation. Patient also took oral amoxicillin 500mg 2x/day (batch/lot# not reported) from Mar 12, 2021 to Mar 15, 2021, for swollen gums. No medical history or concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. No additional vaccines administered on same date of the Pfizer suspect. On Mar 16, 2021, at 22:00, patient experienced itching on sides of stomach/back (from lower back to shoulders), mild rash and very minor redness. Patient stated he took the vaccine on Mar 3, 2021 and it didn't seem like he had any side effects. He stated last week around Mar 16, 2021 (almost 2 weeks after the shot), he started itching a lot. Mar 16, 2021 through yesterday, he stated he had a mild, itchy rash; with itching on his sides and back. Patient stated he had never had a problem with amoxicillin before. On Mar 15, 2021, his doctor switched him to azithromycin 250mg pill by mouth. Therapeutic measures taken as a result of events included Cortisone, lotion, and Gold-Bond powder. The events did not result in physician office or emergency room visit. The outcome of the events: recovering. No follow-up attempts possible. No further information expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Insomnia, Myalgia, Pyrexia
Clinical narrative: Fever running upwards to 100.; Muscle aches; Could not sleep night of shot; This is a spontaneous report from a contactable other healthcare professional (patient). A 69-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 22Mar2021 at 12:30 (at the age of 69-year-old) as dose 2, single for COVID-19 immunisation. The patient had no medical history and did not have any allergies to food, medications, or other products. The patient did not take any concomitant medications. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration in the left arm on 01Mar2021 at 12:30 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19 and did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 22Mar2021 at 20:00, the patient experienced fever and muscle aches. Fever was running upwards to 100 (unspecified units) and the patient could not sleep at night of shot. The adverse event did not result in a visit to the doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care.  Since the vaccination, the patient had not been tested for COVID-19.  No treatment was received for the reported events. The outcome of the events could not sleep at night of shot, fever and muscle aches was not resolved at the time of this report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Bone densitometry, Bone scan, Computerised tomogram
Clinical narrative: minor pain on left shoulder; severe pain in wrist,shoulders and left clavicle.; there is severe arthritis throughout his body; he is experiencing lethargic feelings; he wants to sleep all day; constantly tired; he lost a few pounds; He has low appetite; This is a spontaneous report received from a contactable consumer. This 73-year-old male consumer received 2nd dose of Pfizer COVID vaccine (Batch/Lot Number: EN9581),intramuscular on 18Feb2021,at the age of 73 years old,as Dose 2,single for covid-19 immunization.Medical history included prostate cancer from an unknown date and unknown if ongoing He had Prostate cancer for many years and is being treated by hormone therapy.That is consisting of an injection of a hormonal drug called Lupron and arthritis from an unknown date and unknown if ongoing The Tylenol for Arthritis is 650 mg. He took 2. Lot SJ8033, expiration Jul2023. Count size 24 caplets.It was sealed.He had arthritis before with just minor back pain.Concomitant medication(s) included leuprorelin acetate (LUPRON) taken for prostate cancer from 11Apr2016 to an unspecified stop date.The patient previously took lupron for prostate cancer and experienced therapeutic response shortened, bnt162b2 for covid-19 immunisation and experienced pain in extremity.The patient experienced severe pain in wrist,shoulders and left clavicle there is severe arthritis throughout his body,he is experiencing lethargic feelings, he wants to sleep all day,constantly tired on Feb2021, he lost a few pounds, he has low appetite on Feb2021 and minor pain on left shoulder on 28Feb2021.The patient underwent lab tests and procedures which included bone densitometry: unknown results on 02Mar2021 She said the good news, is the  cancer did not spread to any part of his body. It did not go to his bones and his PSA dropped  tremendously. Bad news is that there is severe arthritis throughout his body,bone scan: unknown results on a bone mineral density,computerised tomogram: unknown results on 10Mar2021 She said the good news, is the cancer did not spread to any part of his body.It did not go to his bones and his PSA dropped  tremendously. Bad news is that there is severe arthritis throughout his body, prostatic specific antigen: 5.07 on 16Dec2020. Therapeutic measures were taken as a result of there is severe arthritis throughout his body.Patient asked the doctor if the vaccine injection could cause a flare up of his arthritis.The doctor could not tell him if there were a reports because the studies were not conclusive yet.The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Injection site pain, Lethargy, Prostatic specific antigen
Clinical narrative: minor pain on left shoulder; severe pain in wrist,shoulders and left clavicle.; there is severe arthritis throughout his body; he is experiencing lethargic feelings; he wants to sleep all day; constantly tired; he lost a few pounds; He has low appetite; This is a spontaneous report received from a contactable consumer. This 73-year-old male consumer received 2nd dose of Pfizer COVID vaccine (Batch/Lot Number: EN9581),intramuscular on 18Feb2021,at the age of 73 years old,as Dose 2,single for covid-19 immunization.Medical history included prostate cancer from an unknown date and unknown if ongoing He had Prostate cancer for many years and is being treated by hormone therapy.That is consisting of an injection of a hormonal drug called Lupron and arthritis from an unknown date and unknown if ongoing The Tylenol for Arthritis is 650 mg. He took 2. Lot SJ8033, expiration Jul2023. Count size 24 caplets.It was sealed.He had arthritis before with just minor back pain.Concomitant medication(s) included leuprorelin acetate (LUPRON) taken for prostate cancer from 11Apr2016 to an unspecified stop date.The patient previously took lupron for prostate cancer and experienced therapeutic response shortened, bnt162b2 for covid-19 immunisation and experienced pain in extremity.The patient experienced severe pain in wrist,shoulders and left clavicle there is severe arthritis throughout his body,he is experiencing lethargic feelings, he wants to sleep all day,constantly tired on Feb2021, he lost a few pounds, he has low appetite on Feb2021 and minor pain on left shoulder on 28Feb2021.The patient underwent lab tests and procedures which included bone densitometry: unknown results on 02Mar2021 She said the good news, is the  cancer did not spread to any part of his body. It did not go to his bones and his PSA dropped  tremendously. Bad news is that there is severe arthritis throughout his body,bone scan: unknown results on a bone mineral density,computerised tomogram: unknown results on 10Mar2021 She said the good news, is the cancer did not spread to any part of his body.It did not go to his bones and his PSA dropped  tremendously. Bad news is that there is severe arthritis throughout his body, prostatic specific antigen: 5.07 on 16Dec2020. Therapeutic measures were taken as a result of there is severe arthritis throughout his body.Patient asked the doctor if the vaccine injection could cause a flare up of his arthritis.The doctor could not tell him if there were a reports because the studies were not conclusive yet.The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Weight decreased
Clinical narrative: minor pain on left shoulder; severe pain in wrist,shoulders and left clavicle.; there is severe arthritis throughout his body; he is experiencing lethargic feelings; he wants to sleep all day; constantly tired; he lost a few pounds; He has low appetite; This is a spontaneous report received from a contactable consumer. This 73-year-old male consumer received 2nd dose of Pfizer COVID vaccine (Batch/Lot Number: EN9581),intramuscular on 18Feb2021,at the age of 73 years old,as Dose 2,single for covid-19 immunization.Medical history included prostate cancer from an unknown date and unknown if ongoing He had Prostate cancer for many years and is being treated by hormone therapy.That is consisting of an injection of a hormonal drug called Lupron and arthritis from an unknown date and unknown if ongoing The Tylenol for Arthritis is 650 mg. He took 2. Lot SJ8033, expiration Jul2023. Count size 24 caplets.It was sealed.He had arthritis before with just minor back pain.Concomitant medication(s) included leuprorelin acetate (LUPRON) taken for prostate cancer from 11Apr2016 to an unspecified stop date.The patient previously took lupron for prostate cancer and experienced therapeutic response shortened, bnt162b2 for covid-19 immunisation and experienced pain in extremity.The patient experienced severe pain in wrist,shoulders and left clavicle there is severe arthritis throughout his body,he is experiencing lethargic feelings, he wants to sleep all day,constantly tired on Feb2021, he lost a few pounds, he has low appetite on Feb2021 and minor pain on left shoulder on 28Feb2021.The patient underwent lab tests and procedures which included bone densitometry: unknown results on 02Mar2021 She said the good news, is the  cancer did not spread to any part of his body. It did not go to his bones and his PSA dropped  tremendously. Bad news is that there is severe arthritis throughout his body,bone scan: unknown results on a bone mineral density,computerised tomogram: unknown results on 10Mar2021 She said the good news, is the cancer did not spread to any part of his body.It did not go to his bones and his PSA dropped  tremendously. Bad news is that there is severe arthritis throughout his body, prostatic specific antigen: 5.07 on 16Dec2020. Therapeutic measures were taken as a result of there is severe arthritis throughout his body.Patient asked the doctor if the vaccine injection could cause a flare up of his arthritis.The doctor could not tell him if there were a reports because the studies were not conclusive yet.The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug hypersensitivity, Swelling
Clinical narrative: hypersensitivity; swelling; This is a spontaneous report from a contactable consumer (patient) via Sales Rep originating from a Nursebased on information received by Pfizer(Mfr. Control number: 21121474US).   A female patient of an unspecified age 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 15Mar2021 as dose 1, single for COVID-19 immunization. Patient also received botulinum toxin type a (BOTOX COSMETIC, Powder for injection), 10 UNITS to forehead and 10 UNITS to glabella on 12Mar2021 (Lot Number: C6736, Expiration Date: 30Nov2023), at 10 iU, single for skin wrinkling. The patient medical history and concomitant medications were not reported. On 16Mar2021 the patient experienced swelling and allergic reaction/hypersensitivity. The patient was going on vacation and was treated with Medrol Dose Pack to relieve the swelling on 16Mar2021. At the time of the report, the outcomes of hypersensitivity and swelling were reported as unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Paraesthesia, Skin irritation
Clinical narrative: The area where the cyst was became very agitated/much more agitated. It feels like a bad sunburn that you cannot see, shocks up my arm; The shoulder and armpit on that side also became sore and tingly; The shoulder and armpit on that side also became sore and tingly; The shoulder and armpit on that side also became sore and tingly/like someone is tingling my armpit; This is a spontaneous report from a contactable consumer (patient). A 57-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration, in Arm, on an unspecified date in 2021 (at the age of 57-year-old) as DOSE 1, SINGLE and  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number and expiration date: not reported), via an unspecified route of administration on 19Mar2021 at 19:00 as DOSE 2, SINGLE, both for covid-19 immunization. Medical history included cyst and that cyst removed from back in the fall and type 2 diabetes (controlled by diet and exercise). Concomitant medications included Inositol supplement, fish oil, vitamins. The patient had no Allergies to medications, food, or other products. No known allergies. The patient was not pregnant at time of vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID -19 vaccine. The Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The patient stated that, on an unspecified date in 2021, after both doses, the area where the patient had cyst was became very agitated. The shoulder and armpit on that side also became sore and tingly.  That side that was agitated became much more agitated.  It felt like a bad sunburn that cannot see, shocks up the arm, randomly like someone is tingling on her armpit.  The patient's health provider said to just let it go and that it is just a reaction to the shot.  They examined patient but the ironic part is there is nothing to see--no rash, etc. It is over a week now and patient becoming concerned and plan to call doctor again today. The events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of the events was not recovered at time of report.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Lethargy, Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Slept most of the day; very lethargic; low fever (99.9); arm sore; This is a spontaneous report from a non-contactable consumer, the patient. A 30-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration, on 25Mar2021 at 13:15 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no concomitant medications. Previously, the patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: Unknown) via an unspecified route of administration, on 04Mar2021 (at the age of 30-years-old) as a single dose for COVID-19 immunisation. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 26Mar2021, the patient experienced arm sore the day of the second vaccine. The next day the patient had a low fever (99.9) and felt very lethargic, slept most of the day with an on and off fever. However, the next morning the patient felt fine and no longer had a fever. The patient did not receive treatment for the reported events. The events neither resulted in doctor or other healthcare professional office/clinic visit nor emergency room/department or urgent care. The clinical outcome of the events arm sore, low fever, very lethargic and slept most of the day were recovered on an unknown date at the time of report.    No follow-up attempts are possible. No further information is expected.  Amendment: This follow-up report is being submitted to amend previously reported information: Vaccination Facility Country added.  No follow-up attempts are needed. No further information is expected.