chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Breast pain, Headache, Vaccination site pain
Clinical narrative: Headache; injection site pain; has pain in her arm that has kind of moved toward her armpit and it is a struggle there in the underarm area; has pain in her arm that has kind of moved toward her armpit up to her elbow; has pain in her arm that has kind of moved toward her armpit and spread to her left breast; This is a spontaneous report from a contactable consumer (patient). A 33-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 18Mar2021 10:00 (Lot Number: EP7534; Expiration Date: 31Jul2021) (at the age of 33-years-old) as dose 1, single for covid-19 immunisation. Medical history included polycystic ovaries (PCOS autoimmune disease) diagnosed when she was a teenager at age 16 years. There were no concomitant medications. There were no prior vaccinations within 4 weeks of COVID-19 vaccine. Adverse event following prior vaccinations included maybe she gets injection site soreness or a 24-hour cold but not every time, once in a blue moon, patient stated it's like the flu shot and patient does not have name, dose of the vaccinations. Patient stated she wanted to report a symptom she was having. She got the 1st shot on 18Mar2021 and she did have a 24-hour headache that went away. The headache started within 2 hours after the shot on 18Mar2021 and was gone by the end of the day 19Mar2021. She had injection site pain from the get-go on 18Mar2021 and would say she noticed it first closer to maybe her left breast, that she was wearing a sports bra and thought it may be too tight. She had pain in her arm that has kind of moved toward her armpit and it was a struggle there in the underarm area in Mar2021. It was her armpit up to her elbow and spread to her left breast in Mar2021. Patient stated that was maybe 3 days after and the arm injection site was still hurting, that she didn't feel underarm until 3 days later. The pain was up to her elbow and she noticed that about a week later, that it traveled into her armpit and out to the side of her arm to her elbow about a week later. This was all on the left side which was where she got the shot. The events did not require emergency room and physician office visit. During supplemental form patient stated she read an article that said all the symptoms should clear within 6 weeks and if it persists to see somebody and she was holding out, but she was a little nervous as the symptoms are the same as breast cancer. She stated then again it pretty much followed the shot and she was just hoping it was a side effect from the shot. Patient just wanted to report this, and she read an article back in January and was wondering if there have been other reports of swollen lymph nodes. The outcome of the event headache was recovered in 19Mar2021 and outcome of all other events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain, Pyrexia
Clinical narrative: body aches; feeling pretty miserable; Fever; worn out; This is a spontaneous report from a contactable consumer. A 80-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date was not reported), via an unspecified route of administration in right arm on 30Mar2021 11:30 (at the age of 80-years-old) at dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date was not reported), via an unspecified route of administration in arm right on 09Mar2021 11:30 (at the age of 80-years-old) at dose 1, single for covid-19 immunization. The patient experienced body aches, felt pretty miserable, fever and worn out on 30Mar2021. Patient was taking Tylenol for the events. The outcome of the event fever was recovered, outcome of the event worn out was unknown outcome of rest of the events was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021366575 same reporter/drug/similar events, different patient.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Hypersensitivity, Malaise, Nausea
Clinical narrative: First COVID-19 vaccine: tired; did not feel good; First COVID-19 vaccine: felt so sick, felt like she was going throw up; First COVID-19 vaccine: little diarrhea; First COVID-19 vaccine: allergies were triggered; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: ER7833), via an unspecified route of administration on 08Mar2021 08:40 (at the age of 56-years-old) as dose 1, single for COVID-19 immunization. Medical history included compromised immune system, seasonal allergy, allergic reactions to things like smells, bites or stings, super hypersensitive. The patient's concomitant medications were not reported. The patient felt so sick, felt like she was going throw up on 10Mar2021, allergies were triggered on 09Mar2021, little diarrhea on 10Mar2021, tired on 11Mar2021 and did not feel good on 10Mar2021. The outcome of all events was recovered on 18Mar2021 or 19Mar2021.   No follow-up attempts are possible. No further information is expected.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: I noticed tingling down my arm and into my 4th and 5th fingers; I noticed aching in my wrists, more on the left than the right; This is a spontaneous report from a contactable Nurse (patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EJ1685 and expiration date: not reported), via an unspecified route of administration, in Left Arm, on 22Dec2020 (at the age of 39-year-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included hypothyroidism. The patient had no known allergies. Concomitant medications included vortioxetine hydrobromide (TRINTELLIX), lamotrigine and levothyroxine sodium (SYNTHROID). 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 been tested since the vaccination. On 22Dec2020, the patient experienced tingling down on arm and into 4th and 5th fingers and noticed aching in wrists, more on the left than the right. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 02Feb2021. It was reported that adverse events resulted in Doctor or other healthcare professional office/clinic visit. Therapeutic measures (unspecified) were taken as a result of events. The outcome of the event Tingling feet/hands was recovered in 22Dec2020 and Wrist pain was recovered on an unspecified date.  No follow up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Second COVID-19 vaccine: Rash on right hand; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: ER7833, expiration date was not reported) via an unspecified route of administration, in left arm, on 29Mar2021 09:30 (at the age of 56-year-old) at dose 2, single for covid-19 immunization. Medical history included ongoing compromised immune system, hypersensitive and has allergic reactions to things like smells, bites, or stings and her seasonal allergies are horrible. There were no concomitant medications. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, lot number: EN6203, expiration date was not reported) via an unspecified route of administration, on 08Mar2021 08:40 (at the age of 56-year-old) at dose 1, single for covid-19 immunization and felt so sick, felt like she was going throw up, allergies were triggered, little diarrhea and tired. The patient did not receive any other vaccines within 4 weeks prior to the covid-19 vaccine. No additional vaccines administered on same date of vaccination. On 29Mar2021, three or four hours after second covid-19 vaccine, the patient had rash on right hand (weird strawberry looking); she clarified that she received the vaccine in her left arm and the rash is on her right hand. The event resulted in physician office visit. There were no investigation assessments. Therapeutic measures were taken included: Doxycycline Hyclate, antibiotics. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dyspnoea, Hyperhidrosis, Nausea, Pain
Clinical narrative: Arm pain; Sleepiness; Sweating and low pressure sensation; Sweating and low pressure sensation; Nausea; Shortness of breath; A never-felt pain in veins and arteries by several parts of the body: left arm, right ankle, anterior skull, left armpit, heart, several points in the lungs.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection; Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 23Mar2021 at 16:15 (at the age of 62-years-old) as dose 1, single for COVID-19 immunization. Medical history included mononucleosis from 2011 to an unknown date and hemorrhagic dengue from 2014 to an unknown date. Concomitant medications were not reported. Patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccine within 4 weeks and other medications in two weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 26Mar2021, after first vaccination, the patient experienced arm pain, sleepiness, sweating and low pressure sensation, nausea, shortness of breath and a never-felt pain in veins and arteries by several parts of the body: left arm, right ankle, anterior skull, left armpit, heart, several points in the lungs. Patient did not receive any treatment for the events. Outcome of all events were not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Somnolence
Clinical narrative: Arm pain; Sleepiness; Sweating and low pressure sensation; Sweating and low pressure sensation; Nausea; Shortness of breath; A never-felt pain in veins and arteries by several parts of the body: left arm, right ankle, anterior skull, left armpit, heart, several points in the lungs.; This is a spontaneous report from a contactable consumer (patient). A 62-years-old non pregnant female patient received first dose of BNT162B2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection; Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 23Mar2021 at 16:15 (at the age of 62-years-old) as dose 1, single for COVID-19 immunization. Medical history included mononucleosis from 2011 to an unknown date and hemorrhagic dengue from 2014 to an unknown date. Concomitant medications were not reported. Patient did not have any allergies to medications, food, or other products. The patient had not received any other vaccine within 4 weeks and other medications in two weeks. Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 26Mar2021, after first vaccination, the patient experienced arm pain, sleepiness, sweating and low pressure sensation, nausea, shortness of breath and a never-felt pain in veins and arteries by several parts of the body: left arm, right ankle, anterior skull, left armpit, heart, several points in the lungs. Patient did not receive any treatment for the events. Outcome of all events were not recovered at the time of report.   No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Joint swelling, Nausea, Pain in extremity
Clinical narrative: Felt nauseated; Headache; Pain visible swelling in right hand; Swelling in right hand; Joint swelling in left knee; Pain in left knee; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 14Mar2021 16:00 (at the age of 45-year-old) (Lot Number: EN6208) as dose 1, single for COVID-19 immunization, The patient was not pregnant at the time of vaccination. Medical history included Bechet's disease, Ehlers Danlos syndrome, chronic migraine, celiac disease, and asthma. Concomitant medication(s) included apermilast (OTEZLA), meloxicam (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and levothyroxine sodium (SYNTHROID), all taken for an unspecified indication, start and stop dates were not reported. The patient previously received pneumococcal vaccine polysacch (PNEUMOVAX VACCIN) on an unknown date for an unknown indication and experienced serious adverse reactions including prolonged high fever and erythema nodosum. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021 at 19:00, the patient experienced visible joint swelling and pain in the left knee with no injury. The patient reported that symptoms had lessened since 14Mar2021. On 15Mar2021, the patient woke up at 03:00 due to pain and visible swelling in the right hand. The left knee and right hand had continued swelling periodically during that time, usually in the late afternoon-evening. On 17Mar2021, for three days following the first dose, the patient felt nauseated and had a headache that felt different from usual migraines. The adverse events resulted in a visit to the doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of felt nauseated, headache, joint swelling in left knee, pain in left knee, pain visible swelling in right hand, and swelling in right hand was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Felt nauseated; Headache; Pain visible swelling in right hand; Swelling in right hand; Joint swelling in left knee; Pain in left knee; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in left arm on 14Mar2021 16:00 (at the age of 45-year-old) (Lot Number: EN6208) as dose 1, single for COVID-19 immunization, The patient was not pregnant at the time of vaccination. Medical history included Bechet's disease, Ehlers Danlos syndrome, chronic migraine, celiac disease, and asthma. Concomitant medication(s) included apermilast (OTEZLA), meloxicam (MANUFACTURER UNKNOWN), montelukast (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and levothyroxine sodium (SYNTHROID), all taken for an unspecified indication, start and stop dates were not reported. The patient previously received pneumococcal vaccine polysacch (PNEUMOVAX VACCIN) on an unknown date for an unknown indication and experienced serious adverse reactions including prolonged high fever and erythema nodosum. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021 at 19:00, the patient experienced visible joint swelling and pain in the left knee with no injury. The patient reported that symptoms had lessened since 14Mar2021. On 15Mar2021, the patient woke up at 03:00 due to pain and visible swelling in the right hand. The left knee and right hand had continued swelling periodically during that time, usually in the late afternoon-evening. On 17Mar2021, for three days following the first dose, the patient felt nauseated and had a headache that felt different from usual migraines. The adverse events resulted in a visit to the doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. The clinical outcome of felt nauseated, headache, joint swelling in left knee, pain in left knee, pain visible swelling in right hand, and swelling in right hand was resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Vaccination site erythema
Clinical narrative: Tired; Muscle ache; Redness marks on the skin near the vaccine area; This is a spontaneous report from a contactable consumer, the patient. A 33-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 24Mar2021 at 12:00 (at the age of 33-years-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not take concomitant medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 24Mar2021, the patient experienced tired, muscle ache, redness marks on the skin near the vaccine area. The events did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events tired, muscle ache, redness marks on the skin near the vaccine area was recovered on an unknown date in 2021.   No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: I am experiencing a lot of pain in my hip like muscle. I am experiencing a lot of pain in my hip like muscle. This is a spontaneous report from a contactable consumer. This consumer (patient) of unknown gender reported for self that he/she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 30Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unknown date the patient experienced a lot of pain in his/her hip like muscle. The patient was wondering if I could take Tylenol or Aspirin or something maybe that it help relieve it. The event outcome was unknown.  No follow-up attempts were possible; Information about lot/batch number could not be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swollen lymph node in under arm on side of vaccination; This is a spontaneous report from a non-contactable consumer, the patient. A 29-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 30Mar2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 09Mar2021 (at the age of 29-years-old) as a single dose for COVID-19 immunisation. On 31Mar2021, the patient experienced swollen lymph node in under arm on side of vaccination. No therapeutic measures were taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event Swollen lymph node in under arm on side of vaccination was unknown at the time of this report.   No follow-up attempts are possible. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat; This is a spontaneous report from a non-contactable healthcare professional, the patient. A 19-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the left arm on 31Mar2021 at 08:30 (at the age of 19-year-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the vaccination. The patient did not receive any other medications within two weeks of vaccination. On 01Apr2021 at 07:00, the patient experienced sore throat. The event did not result in doctor or other healthcare professional office/clinic, emergency room/department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event sore throat was recovering at the time of report.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Chest X-ray, Cough, Eye irritation, Rhinorrhoea, Throat irritation
Clinical narrative: nose is running; back of throat is itching; coughing a lot; eyes are burning; This is a spontaneous report from a contactable consumer (patient). A 59-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration, administered on the left arm on 25Mar2021 08:00 (Lot Number: NE6208) (at the age of 59 years old) as dose 1, single for COVID-19 immunisation. The vaccine was administered in a Hospital facility. The patient's medical history included ongoing high blood pressure (diagnosed 10 or 12 years ago) and surgery (had surgery ten years ago). The patient takes his normal medications every day. On 26Mar2021, the patient experienced nose is running, back of throat is itching, coughing a lot, and eyes are burning. The patient stated that his "nose is running" has dried up now, but in a little bit, it'll start running again soon. The patient underwent lab tests and procedures which included an x-ray of his chest: unknown result on an unspecified date. The patient started taking dextromethorphan hydrobromide;doxylamine succinate;ephedrine sulfate;ethanol;paracetamol (NYQUIL), paracetamol (TYLENOL), guaifenesin (ROBITUSSIN), eucalyptus globulus oil;menthol (HALLS), and hot tea but the events keep on persisting. The patient has not recovered from the events.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable consumer or other non-healthcare professional. A patient, of unspecified age and gender, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# and expiry date not reported), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date, patient had a rash. Patient stated, "I have a rash and it's now 5 weeks. My dermatologist has got me on a program of steroids (unspecified steroids). I am wondering if there is any advice that you have or someone to give me that is the right program to be on?" Patient also stated, "It is from the COVID-19 vaccine. It happened after my first shot. I went to my dermatologist and my general practitioner and they said well it's a rash; go take the second shot because that is more important and we can resolve the rash. Well that was 5 weeks ago, now I want to know how get these things clean down." The outcome of the event: unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Sensory disturbance, Vaccination site discomfort, Vaccination site reaction
Clinical narrative: left shoulder bothered/ feeling of bother in the morning had been going on for over a week and was getting a little bit worse; got a pulsating feeling where the vaccine was given; got a pulsating feeling where the vaccine was given; muscle in left arm got a little sore; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6207), via an unspecified route of administration, administered in the left arm (reported as left upper shoulder) on 17Mar2021 (between 13:30 and 13:45, as reported) as dose 1, single for COVID-19 immunisation. The patient has no medical history and concomitant medications. The patient did not receive any other vaccines within four weeks of vaccination. The patient reported that he received the vaccine on 17Mar2021 and the first week he was fine but in the previous weekend he was not. In the morning (on an unspecified date in 2021), his left shoulder bothered. The patient reported that he received the vaccine in his left shoulder and he sometimes slept on his left shoulder. In the morning, it bothered the caller and this bother did go away later on. This feeling of bother in the morning had been going on for over a week and was getting a little bit worse. On an unspecified date in 2021, the patient also got a pulsating feeling where vaccine given. He was working in the yard for about an hour and a half, after he got a pulsating feeling where the vaccine was given. The patient stated that it didn't bother him for a long time, it was just annoying and kept occurring every day. He called the county where he was located after receiving the vaccine and was told by a nurse to massage it and take paracetamol (TYLENOL) if symptoms continued. The patient took paracetamol and stated it did go away on its own. In the morning when caller awakened (on an unspecified date in 2021), it bothered him, not a lot but it was annoying. The patient wanted to know how long the symptoms is going to go on, and what to do to get rid of them. He was told when he goes back to receive his second dose vaccine to make sure it was given in his other arm. The patient also reported that some days the left shoulder bothered a little bit more than other days. This depended on how much pressure, the patient was lying in bed in the morning (on an unspecified date) and leaned down on elbow and the muscle in left arm got a little sore. The patient stated that it was not real, real, painful but it was there. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Blood test normal, Pruritus, Swelling
Clinical narrative: Caller states in early Feb2021 or late Jan2021, she had the pneumonia shot. She had some swelling and itchiness; Caller states in early Feb2021 or late Jan2021, she had the pneumonia shot. She had some swelling and itchiness; This is a spontaneous report from a contactable consumer (patient).  An 83-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, lot unknown), via an unspecified route of administration on an unspecified date in 2021 (early Feb2021 or late Jan2021) at unknown dose, single for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced some swelling and itchiness on unknown date in 2021. She took Benadryl and it went away. The patient underwent laboratory test on unspecified date which included blood test: good, everything was fine. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Chills, Electrocardiogram, Headache, Injection site pain
Clinical narrative: Have pain at the site; Slight headache; Muscle pain; Chills; Have severe itching all over my body; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6205, Expiry date was not reported) via intramuscular route of administration, administered in Arm Left on 17Mar2021 (at the age of 68 years old) as DOSE 2, SINGLE for covid-19 immunisation. Also, the patient has received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: GL9266, Expiry date was not reported) via intramuscular route of administration, administered on 24Feb2021 as DOSE 1, SINGLE for covid-19 immunisation which leads to pain at the site. The patient medical history included cholesterol and acid reflux from an unknown date and unknown if ongoing. The reporter stated that, I do not know what I wanted to tell you about myself as far as medical conditions. I do not have anything that should affect this, I normally every year get the flu shot for instance, I have Pneumonia shot, I have Shingles shot, so I get all my inoculations as far as others. Concomitant medication(s) included atorvastatin (ATORVASTATIN) taken for blood cholesterol abnormal from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for gastroesophageal reflux disease, start and stop date were not reported, saccharomyces boulardii (FLORASTOR SACCHAROMYCES BOULARDII) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. On 28Mar2021 the patient experienced have severe itching all over my body. On an unspecified date the reporter stated that, he has pain at the site from both shots (COVID Shot), the second was worse than the first, he did have the second time slight headache and muscle pain for about a day. He also has chills but that was only for an hour. The patient underwent lab tests and procedures which included blood test with results as normal on unspecified date, electrocardiogram with results as normal on unspecified date, weight 200, actually it is 199 I was rounding it up on unspecified date. The outcome for the event, have severe itching all over my body was not recovered and the outcome for the events have pain at the site, slight headache, muscle pain, chills was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pruritus, Weight
Clinical narrative: Have pain at the site; Slight headache; Muscle pain; Chills; Have severe itching all over my body; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EN6205, Expiry date was not reported) via intramuscular route of administration, administered in Arm Left on 17Mar2021 (at the age of 68 years old) as DOSE 2, SINGLE for covid-19 immunisation. Also, the patient has received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: GL9266, Expiry date was not reported) via intramuscular route of administration, administered on 24Feb2021 as DOSE 1, SINGLE for covid-19 immunisation which leads to pain at the site. The patient medical history included cholesterol and acid reflux from an unknown date and unknown if ongoing. The reporter stated that, I do not know what I wanted to tell you about myself as far as medical conditions. I do not have anything that should affect this, I normally every year get the flu shot for instance, I have Pneumonia shot, I have Shingles shot, so I get all my inoculations as far as others. Concomitant medication(s) included atorvastatin (ATORVASTATIN) taken for blood cholesterol abnormal from an unspecified start date and ongoing; omeprazole (OMEPRAZOLE) taken for gastroesophageal reflux disease, start and stop date were not reported, saccharomyces boulardii (FLORASTOR SACCHAROMYCES BOULARDII) taken for an unspecified indication, start and stop date were not reported; vitamin d3 (VITAMIN D3) taken for an unspecified indication, start and stop date were not reported. On 28Mar2021 the patient experienced have severe itching all over my body. On an unspecified date the reporter stated that, he has pain at the site from both shots (COVID Shot), the second was worse than the first, he did have the second time slight headache and muscle pain for about a day. He also has chills but that was only for an hour. The patient underwent lab tests and procedures which included blood test with results as normal on unspecified date, electrocardiogram with results as normal on unspecified date, weight 200, actually it is 199 I was rounding it up on unspecified date. The outcome for the event, have severe itching all over my body was not recovered and the outcome for the events have pain at the site, slight headache, muscle pain, chills was recovered.  No follow-up attempts are possible. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; Fever (102 Fahrenheit); Headache; Body aches; This is a spontaneous report from a contactable consumer (patient). A 23-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EP6955), via an unspecified route of administration in the left arm on 30Mar2021 at 09:00 (at the age of 23-year-old), dose 2, single for COVID-19 immunisation. Medical history included migraines. Concomitant medication included propranolol. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL3247) administered via an unspecified route of administration in the left arm on 09Mar2021 at 09:00 (at the age of 23-year-old), dose 1, single for COVID-19 immunisation. On 30Mar20221, the patient experienced chills, fever (102 Fahrenheit), headache, body aches. No treatment was received for the event. The outcome of the event chills was recovered on an unspecified date and outcome of other events was recovered on 01Apr2021.  No follow-up attempts are possible; No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site erythema
Clinical narrative: Extreme fatigue; Minor redness at injection site; This is a spontaneous report from a non-contactable pharmacist. A 35-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 31Mar2021 as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced Patient reported extreme fatigue starting around 20 hours post vaccination. No other side effects to vaccine besides minor redness at injection site. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care.Since the vaccination, the patient had not been tested for COVID-19. No therapeutic measures were taken as a result of the reported events The clinical outcome of the event extreme fatigue and minor redness at injection site was resolved on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itchy; This is a spontaneous report from a contactable consumer (patient). An 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number: EM9809), via an unspecified route of administration, administered in left arm (reported as left upper arm), on 25Feb2021 at 11:30 (age at vaccination was 80-year-old) as dose 1, single for COVID-19 immunization. The patient's medical history included allergies to sulfa and penicillin. The patient's concomitant medications were reported as none. The patient previously took nitrofurantoin (MACROBID) and experienced allergy. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. On Mar2021, the patient experienced itchy. It was further reported that four or five days later after the vaccine, patient had itchy (no rash), just itchy. The patient's dermatologist prescribed triamcinolone acetonide cream 0.1% in the tube for 3-4 times a day as needed and was reported that it helped a little bit (it worked), but then it didn't work. It was reported that itchy had sort of tapered off, wasn't gone but had tapered off. The outcome of the event was recovering.  No follow up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Insomnia, Joint range of motion decreased, Pain in extremity, Pyrexia
Clinical narrative: legs were aching; fever was 100.8 degrees; could not sleep; could not lift her leg; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EN6205; Expiration Date: Jun2021 at 10:20), via an unspecified route of administration, administered in left arm on 31Mar2021 (age at vaccination was 77-year-old) as dose 2, single for COVID-19 immunization. The patient's medical history included allergies, compromised immune status, respiratory illness, genetic /chromosomal abnormalities, endocrine abnormalities, diabetes and obesity. There was no concomitant medications. The patient previously took aspirin [acetylsalicylic acid]. The patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot Number: EL9254; Expiration Date: May2021), via an unspecified route of administration, administered in left arm on 09Mar2021 (age at vaccination was 77-year-old) as dose 1, single for COVID-19 immunization. The patient did not receive any other vaccine within 4 weeks prior to COVID-19 vaccine. On 31Mar2021, the patient experienced fever was 100.8 degrees at 08:57, legs were aching at 10:21, could not sleep and could not lift her leg. It was further reported that the patient woke up and her legs were aching. It was reported that it felt like someone was stabbing her with a butcher knife in her legs and she could not sleep. It got worse and better and at the report date it was a little better. The patient's fever was 100.8 degrees and at time of report it was under 100 degrees. She can lift her leg a little now since she could not before. The patient would like to know if she can take an aspirin or paracetamol (TYLENOL), 24 hours after having the second vaccine. The patient underwent lab tests and procedures which included body temperature of 100.8 degrees (fever) on 31Mar2021 at 08:57 and  under 100 degrees on an unspecified date of 2021. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Blood glucose abnormal, Blood glucose decreased, Headache
Clinical narrative: I am also having the side effects; this hurts me really bad; The tissue inside around the bones and in joints it just 'baffled'; I have so much pain I can't move my foot; I have pain in my hip bone; I have pain in my back; I can't hear well; Headache; Ankles swollen; It makes my sugar drop; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EN6204), via an unspecified route of administration on an unspecified date (at the age of 72-years) as dose 1, single for covid-19 immunization. Patient had relevant medical history. The patient did not had concomitant medications. The patient also had the side effects from the first shot (Covid Vaccine by Pfizer), this hurts her really bad, the tissue inside around the bones and in joints it just baffled and the patient had so much pain. The patient did not move her foot, had pain in her hip bone and pain in her back. The patient did not hear well and had headache and her ankles was swollen. The patient had the shot for long time and it makes her sugar drop that was common or not. The pain started after a week. The patient should go ahead or not for the second dose that was main thing that the patient want to know. The patient was informed about the Pfizer Medical Information and provided with the (number withheld) and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday and for Saturday and Sunday timings are 9 AM to 3 PM as per EST. The patient stated, 15Mar2021 and scheduled for second dose on 05Apr2021. Other medications: the patient stated, she took a lot of medications, about 20, she did not know and they need to know where the patient took the vaccine at the place. The patient went lab test: Blood glucose abnormal: drop. The outcome of the events was unknown.   QR Comment: Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Joint swelling, Limb discomfort, Pain
Clinical narrative: I am also having the side effects; this hurts me really bad; The tissue inside around the bones and in joints it just 'baffled'; I have so much pain I can't move my foot; I have pain in my hip bone; I have pain in my back; I can't hear well; Headache; Ankles swollen; It makes my sugar drop; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received bnt162b2 (COMIRNATY, solution for injection, Batch/Lot Number: EN6204), via an unspecified route of administration on an unspecified date (at the age of 72-years) as dose 1, single for covid-19 immunization. Patient had relevant medical history. The patient did not had concomitant medications. The patient also had the side effects from the first shot (Covid Vaccine by Pfizer), this hurts her really bad, the tissue inside around the bones and in joints it just baffled and the patient had so much pain. The patient did not move her foot, had pain in her hip bone and pain in her back. The patient did not hear well and had headache and her ankles was swollen. The patient had the shot for long time and it makes her sugar drop that was common or not. The pain started after a week. The patient should go ahead or not for the second dose that was main thing that the patient want to know. The patient was informed about the Pfizer Medical Information and provided with the (number withheld) and requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday and for Saturday and Sunday timings are 9 AM to 3 PM as per EST. The patient stated, 15Mar2021 and scheduled for second dose on 05Apr2021. Other medications: the patient stated, she took a lot of medications, about 20, she did not know and they need to know where the patient took the vaccine at the place. The patient went lab test: Blood glucose abnormal: drop. The outcome of the events was unknown.   QR Comment: Reason of delay: Daily spike of incoming calls due to COVID19 vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dyspnoea, Pyrexia
Clinical narrative: a high fever; Persistent dry cough; shortness of breath; This is a spontaneous report from a non-contactable other healthcare professional (nurse). A 61-years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EP7534), via an unspecified route of administration, administered in left arm on 18Mar2021 (at the age of 61-years) as dose 1, single for covid-19 immunization at a Pharmacy or Drug Store. The patient medical history included asthma since 4yo, under control; high cholesterol. The patient had known allergies to drug Penicillin, Floxin, Singulaire. The patient's concomitant medications included budesonide, formoterol fumarate (SYMBICORT); hctz (HCTZ); simvastatin (SIMVASTATIN) taken for unspecified indication, start/stop date not reported. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccine within 4 weeks. The patient had been diagnosed with COVID-19 prior to vaccination on an unspecified date in Mar2021. One week following vaccination on 26Mar2021, the patient had persistent dry cough, shortness of breath. On 28Mar2021, the patient had high fever for 24 hours. The patient did not receive any treatment for the events. The patient had not been tested for COVID-19 since the vaccination. The outcome of the event high fever was recovered while the other events was recovering.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.