chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fatigue, Nausea, Pain, Palpitations
Clinical narrative: body aches; Nausea; Tiredness; Palpitations; breathing heavy; vomited once; This is a spontaneous report from a Pfizer sponsored program via a contactable male consumer (patient) reported for himself. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced side effects which included body aches, nausea and tiredness, stated right after the vaccine he had some palpitations and was breathing heavy, he had vomited once and had body aches. The patient asked if those side effects were normal and if they would be up until the second dose. The patient wanted to know how long those symptoms were going to last. He stated if they were going to last until the 21 days until the second dose, he may not get the second dose because he did not like the way he was feeling. He also wanted to know how effective the vaccine was if he only gets the one dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vomiting
Clinical narrative: body aches; Nausea; Tiredness; Palpitations; breathing heavy; vomited once; This is a spontaneous report from a Pfizer sponsored program via a contactable male consumer (patient) reported for himself. A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on an unspecified date (age at vaccination was unknown) as dose 1, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced side effects which included body aches, nausea and tiredness, stated right after the vaccine he had some palpitations and was breathing heavy, he had vomited once and had body aches. The patient asked if those side effects were normal and if they would be up until the second dose. The patient wanted to know how long those symptoms were going to last. He stated if they were going to last until the 21 days until the second dose, he may not get the second dose because he did not like the way he was feeling. He also wanted to know how effective the vaccine was if he only gets the one dose. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Dizziness, Fatigue, Gait inability, Headache
Clinical narrative: Dizziness; Bone pain; Fever; Headache; barely able to walk; terrible pain in the arm; tired; sleepy; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that:  A 44-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0161), via an unspecified route of administration, administered in Arm Right on 24Apr2021 09:00 (At the age of 44 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included intervertebral dislocated disc and migraine from an unknown date and unknown if ongoing. Patient was allergies to Sulfa and Bactrim when queried for Lot number of bactrim, they found out she was allergic to bactrim at 16 years old, her face was like burned with water blisters in the face, that was almost 30 years ago. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient's concomitant medication no because she is not taking medication, she is taking Tylenol. Patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8737), via an unspecified route of administration, administered in Arm Right on 03Apr2021 (At the age of 44 years) as DOSE 1, SINGLE for covid-19 immunisation. Patient had no issues with vaccine in the past, every year she gets the flu vaccine when it is cold season and has no problems. On the evening of 24Apr2021, patient was feeling terrible pain in the arm, tired, sleepy. On25Apr2021, the patient had experienced fever, bone pain, headache, dizziness, patient basically wasn't able to move, till yesterday, before yesterday she was barely able to walk with even little tasks, she was barely able to walk. Treatment Tylenol. Yesterday she started to take Motrin.On29Apr2021, the outcome of the event fever was recovered. At the time of reporting, the events bone pain, dizziness and barely able to walk were resolving, event headache was not recovered whereas the outcome of the events terrible pain in the arm, tired and sleepy were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Somnolence
Clinical narrative: Dizziness; Bone pain; Fever; Headache; barely able to walk; terrible pain in the arm; tired; sleepy; This is a spontaneous report from a contactable consumer. This consumer (patient) reported that:  A 44-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EW0161), via an unspecified route of administration, administered in Arm Right on 24Apr2021 09:00 (At the age of 44 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included intervertebral dislocated disc and migraine from an unknown date and unknown if ongoing. Patient was allergies to Sulfa and Bactrim when queried for Lot number of bactrim, they found out she was allergic to bactrim at 16 years old, her face was like burned with water blisters in the face, that was almost 30 years ago. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The patient's concomitant medication no because she is not taking medication, she is taking Tylenol. Patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8737), via an unspecified route of administration, administered in Arm Right on 03Apr2021 (At the age of 44 years) as DOSE 1, SINGLE for covid-19 immunisation. Patient had no issues with vaccine in the past, every year she gets the flu vaccine when it is cold season and has no problems. On the evening of 24Apr2021, patient was feeling terrible pain in the arm, tired, sleepy. On25Apr2021, the patient had experienced fever, bone pain, headache, dizziness, patient basically wasn't able to move, till yesterday, before yesterday she was barely able to walk with even little tasks, she was barely able to walk. Treatment Tylenol. Yesterday she started to take Motrin.On29Apr2021, the outcome of the event fever was recovered. At the time of reporting, the events bone pain, dizziness and barely able to walk were resolving, event headache was not recovered whereas the outcome of the events terrible pain in the arm, tired and sleepy were unknown.  No follow-up attempts are needed. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Cough, Haemoptysis, Lacrimation increased, Rhinorrhoea, Wheezing
Clinical narrative: wheezing; coughing; bringing up blood when coughing; nose is running; eyes are running and it never stops and makes it hard for him to see; This is a spontaneous report from a contactable consumer reporting for her husband. A 77-Years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EP7533; Expiration date: Unknown) on 27Apr2021 at 13:05 via an unspecified route of administration as DOSE 1, single for covid-19 immunisation (age at vaccination: 77-Years-old). The patient medical history includes While probing for the patient weight it was reported that his weight was fluctuating. He used to be 250lbs about 7 months ago, now he was about 185 lbs. In the last 2 years patient had two heart surgeries, four heart stents, and underwent chemotherapy for six months. Patient had colon cancer, liver cancer and lung cancer from an unknown date and unknown if it was ongoing. He got rid of the colon cancer and now the lung cancer was getting treated. He used to be a type 2 diabetic but after he lost all the weight the diabetes was gone. The patient was allergic to Penicillin. He swelled up like a balloon and turned bright red and his allergic reaction happened in 1965. The reporter does not have the NDC/Lot/Expiry for Penicillin. The patient was not taking any concomitant medication of concern. The patient did not receive any other vaccine on same date with the Pfizer vaccine. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccination. The patient did not have any AE (s) prior vaccination. On 27Apr2021, the patient experienced wheezing, coughing, bringing up blood when coughing, nose was running, eyes are running, and it never stops and makes it hard for him to see. The reporter mentioned that the blood that patient bringing up when coughing was not a lot of blood but it's still a concern. The reporter was trying to give him a lot of water because that's what the paperwork says to do. The reporter and her husband were scheduled for their second Covid 19 vaccines on 18May2021. The patient did not visit emergency room or physician office due to events. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Myalgia, Pain in extremity, Weight
Clinical narrative: Pain in her finger, in the muscles and bone and finger joint; Pain in her finger, in the muscles and bone and finger joint; Pain in her finger, in the muscles and bone and finger joint; Pain in her finger, in the muscles and bone and finger joint; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received second dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EL9269, Expiry Date: Unknown), dose 2 via an unspecified route of administration on 09Feb2021 (at the age of 63-year-old) as dose 2, single for COVID-19 immunisation. Medical history included thyroid for many years. Concomitant medication(s) included trazodone and melatonin taken for thyroid from an unspecified date. The patient's historical vaccine included first dose of bnt162b2 (BNT162B2, solution for injection, Lot Number: EL3747 or it could be EV3747, Expiry Date: Unknown), dose 1 via an unspecified route of administration on 19Jan2021, as dose 1, single for COVID-19 immunisation. The patient experienced pain in her finger, in the muscles and bone and finger joint on an unspecified date. Patient was called about the Pfizer Corona virus vaccine. She obviously has something, in the bone sometimes and sometimes in the muscle it is painful, it is a pain that never happened before, so she thinks the vaccine is the reason, but the pain is very soon and sudden and then it is gone. it is in the bone and muscles in her finger, in the bone and it is painful. It comes very fast and then it is gone. Sometimes she sits down for a while and the pain comes and then it's gone comes on soon and is fast to disappear. She stated weighs more now she has gained 10 pounds, she has never had such weight, never. The pain is in the muscles, and it is gone fast, a sudden pain and then it's gone, it is in her finger. She clarifies it is in the joint, the finger. It happens more often, it happens every day, she did not pay attention to when it started, it just got her attention, it is painful in the joint. She clarifies she does not know when it started but it happens every day. She asked does she need to make a blood test to see anything gas changed or something like that. The patient underwent lab tests and procedures which included weight: 105 or 107 on an unspecified date, (before she weighed 105 or 107 now, she weighs 116 or 117) and weight: 116 or 117 on an unspecified date. (Increase- before she weighed 105 or 107 now, she weighs 116 or 117). The clinical outcome of the events was reported as not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Bronchial secretion retention, Pain in extremity, Pharyngitis
Clinical narrative: Infection in my throat; I have pain in my shoulders, arms and legs; back pain; I have pain in my shoulders, arms and legs; back pain; I have pain in my shoulders, arms and legs; back pain; I have mucus in my chest; This is a spontaneous report from a contactable consumer (patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 28Apr2021 (at the age of 78-years-old) as dose 1, single for covid-19 immunization. The patient medical history was not reported. Concomitant medication included levothyroxine sodium (SYNTHROID, 88 mg) taken for thyroid disorder, from an unknown date. It was reported that patient got her vaccine (clarified as Pfizer Covid vaccine) and on 29Apr2021 experiencing some infection in her throat, other than she is okay but she should say she have pain in her shoulders, arms and legs but it's not severe but she do have the side effects from shot it's my back arms and legs but its not severe. It's not severe, she is able to do her work but its very uncomfortable but not severe. Another reason is that she have mucus in her chest, this is first she notice. She got the shot the other day, the day after the shot she have back pain, arm and legs, she can work, she can cook she can do everything but she have pain. She is concerned about the mucus. The outcome of the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on her back and jaw; This is a spontaneous report from a Pfizer sponsored program via a contactable consumer (Patient).  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via an unspecified route of administration on 23Apr2021 as Dose 1, single for COVID-19 immunization. Medical history and family history was not reported. The patient's concomitant medications were not reported. On 23Apr2021 (2 hours later of Vaccine), the patient broke out in hives on her back and jaw. She was scheduled for her 2nd dose on 10May2021. Outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nasal congestion, Nasopharyngitis, Pain in extremity
Clinical narrative: sore arm; headache; full week of head cold (sneezing, runny nose, congestion); full week of head cold (sneezing, runny nose, congestion); full week of head cold (sneezing, runny nose, congestion); full week of head cold (sneezing, runny nose, congestion); fatigue; This is a spontaneous report from a non-contactable 32-year-old -female consumer(patient) reported for herself.  A 32-year-old female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EP7533, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 01Apr2021 at 16:00 as dose 1, single for COVID-19 immunization. Medical history included known allergies Sulfa. Concomitant medication(s) included etonogestrel (NEXPLANON), spironolactone (SPIRONOLACTONE), bupropion (BUPROPION) and citalopram (CITALOPRAM). Patient did not have covid prior vaccination and has not been tested covid post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced sore arm, headache, full week of head cold, full week of head cold (sneezing, runny nose, congestion), and fatigue. It was reported that after First Shot: sore arm, headache, fatigue, full week of head cold (sneezing, runny nose congestion). The patient did not receive any treatment for the events. The outcome of events were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: sore arm; headache; full week of head cold (sneezing, runny nose, congestion); full week of head cold (sneezing, runny nose, congestion); full week of head cold (sneezing, runny nose, congestion); full week of head cold (sneezing, runny nose, congestion); fatigue; This is a spontaneous report from a non-contactable 32-year-old -female consumer(patient) reported for herself.  A 32-year-old female patient (not pregnant at the time of vaccination) received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: EP7533, Expiry date: unknown) via an unspecified route of administration, administered in left arm on 01Apr2021 at 16:00 as dose 1, single for COVID-19 immunization. Medical history included known allergies Sulfa. Concomitant medication(s) included etonogestrel (NEXPLANON), spironolactone (SPIRONOLACTONE), bupropion (BUPROPION) and citalopram (CITALOPRAM). Patient did not have covid prior vaccination and has not been tested covid post vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On an unspecified date, the patient experienced sore arm, headache, full week of head cold, full week of head cold (sneezing, runny nose, congestion), and fatigue. It was reported that after First Shot: sore arm, headache, fatigue, full week of head cold (sneezing, runny nose congestion). The patient did not receive any treatment for the events. The outcome of events were unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Inflammation, Lip swelling, Pain in extremity
Clinical narrative: Lip is huge; Right arm is in so much pain; Feels like her body is inflamed; Her elbow hurts; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date in Apr2021 as dose 2, single for COVID-19 immunization. Medical history included Crohn's disease, Ganglion cyst and immunocompromised from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: unspecified), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced body ache, fast heart rate, sneezing and joint pain. Patient stated she was on day 9 of the second vaccine, she had Crohn's disease, so she was already immunocompromised. She stated but then after the second vaccine, on an unspecified date in 2021, her lip was huge, her right arm was in so much pain which she has had a Ganglion Cyst in her wrist, but she felt like her body was inflamed and her elbow hurts because she thought the cyst is pressing on it. The clinical outcome for the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Bronchitis, Cough, Influenza, Product dose omission issue
Clinical narrative: couldn't get their 2nd dose.; Flu; coughing; bronchitis; This is a spontaneous report from a contactable consumer (patient's wife) re-ported for a 82-year-old male patient (reporter's husband) received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: PFEN6207 and expiry date was not reported), via an unspecified route of administration, in Arm Right, on 18Mar2021 at 11:30 (age at vaccination: 82 years), as dose 1, single dose for COVID-19 immunization. The patient's medical history included ongoing diabetes mellitus (diagnosed at 35 years old), high blood pressure (diagnosed approximately in 1960), and Blood cholesterol (diagnosed approximately in 1960). Concomitant medications were not reported. The patient did not receive any vaccine prior vaccinations (within 4 weeks). The reporter reported that on an unspecified date, the patient got sick with flu and bronchitis. The patient had coughing already and got checked out and were ok. The reporter clarified that the patient got sick with flu and couldn't get their 2nd dose. The reporter did not know the date the 2nd dose was supposed to be given. The events did not require a visit to emergency room and physician office. There were not relevant tests. Outcome of the event coughing was recovered on an unspecified date and for other events, it was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Eating disorder, Hyperhidrosis, Hyperventilation, Malaise
Clinical narrative: I suddenly woke up, not feeling well and sweating; I suddenly woke up, not feeling well and sweating; Breathing heavy; Can't finish going to bathroom and it's burning up; Can't eat; This is a spontaneous report from a contactable consumer (patient, self-reported).   A 64-year-old male patient received a dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW861 and expiry date was not reported), via an unspecified route of administration, on an unspecified date, as dose number unknown, single for COVID-19 immunization. The patient's medical history included diabetes. Concomitant medications were not reported (he did not have a list at that moment, might be in his wallet). The patient stated that he needed to report the side effect and asked was this only for severe side effects. On an unknown date, the patient stated he suddenly woke up, not feeling well and sweating, a kind of breathing heavy, cannot finish going to the bathroom. He still not feeling well, and it was burning up. He tried to eat, cannot eat, now can eat he just finish eating. he thinks it was very mild thing and thinks he could report this. The patient stated sometimes from side effects he gets from diabetes medication (unspecified medication) he guessed. Same was the side effects of this. He had diabetes. Sometimes he has the exact (side effects) it seems almost like same but not really. The patient did not receive any treatment for the events. Outcome of the events were unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Experienced low grade fever; This is a spontaneous report from a contactable consumer.  A 21-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration on 05May2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. On unspecified date patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced low grade fever on May2021. At the time of reporting, the outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia
Clinical narrative: headache; chills; fever; This is a spontaneous report received from a contactable consumer (patient). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 04May2021 as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history included Covid 19. The patients concomitant medications were not reported. It was reported he received the Pfizer COVID-19 vaccine on 04May2021. He was experiencing some symptoms it is been two days headache chills and fever in May2021. He stated he had COVID and received the antibody infusion. A lot of people of ask him why he was getting vaccinated since he had the antibodies. The clinical outcome of the events was unknown.  No follow attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Chills, Dysstasia, Fatigue, Flushing
Clinical narrative: equilibrium "way off", chills, "flushing" but no fever, "excessive" headaches, fatigue; equilibrium "way off", chills, "flushing" but no fever, "excessive" headaches, fatigue; equilibrium "way off", chills, "flushing" but no fever, "excessive" headaches, fatigue; Excessive" headaches; Fatigue; she can't stand; This is a spontaneous report from a contactable consumer(patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 01May2021 as Dose 1, Single for Covid-19 immunization. The patient's medical history included COVID-19. The patient's concomitant medications were not reported. On 01May2021, the patient stated that it had been 5 days since and she had still experiencing side effects. She had experienced equilibrium "way off", chills, "flushing" but no fever, "excessive" headaches, fatigue, but no problems with breathing, vomiting, or diarrhea. She stated she was starting to feel better but, the equilibrium was creating a problem where she can't stand or lay for lengths of time without "literally having to close her eyes." She stated that her daughter was currently in the hospital, and she wanted to visit her, but wanted to know if it was recommended, she go if she was experiencing these side effects. The outcome of events equilibrium "way off" was not recovering and the outcome of other events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: equilibrium "way off", chills, "flushing" but no fever, "excessive" headaches, fatigue; equilibrium "way off", chills, "flushing" but no fever, "excessive" headaches, fatigue; equilibrium "way off", chills, "flushing" but no fever, "excessive" headaches, fatigue; Excessive" headaches; Fatigue; she can't stand; This is a spontaneous report from a contactable consumer(patient). A 69-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 01May2021 as Dose 1, Single for Covid-19 immunization. The patient's medical history included COVID-19. The patient's concomitant medications were not reported. On 01May2021, the patient stated that it had been 5 days since and she had still experiencing side effects. She had experienced equilibrium "way off", chills, "flushing" but no fever, "excessive" headaches, fatigue, but no problems with breathing, vomiting, or diarrhea. She stated she was starting to feel better but, the equilibrium was creating a problem where she can't stand or lay for lengths of time without "literally having to close her eyes." She stated that her daughter was currently in the hospital, and she wanted to visit her, but wanted to know if it was recommended, she go if she was experiencing these side effects. The outcome of events equilibrium "way off" was not recovering and the outcome of other events was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasal disorder, Pain
Clinical narrative: He had the nasal and the cough; He had the nasal and the cough; Aching all over; This is a spontaneous report from a contactable consumer (Patient's father). A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration on an unspecified date in 2021 as dose 2, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. On an unspecified date in 2021, the patient had the nasal and the cough, and aching all over. The reporting father stated that his son got it and his second one really hit him hard. He missed a days work and he never misses a day work and his second shot bothered him and his first shot did not. He did not run a temperature, but he had the nasal and the cough and the aching all over and he was still dealing with it (on 2021) and he had his second shot Monday or Friday but he was getting better. The outcome for the events was recovering.  No follow-up attempts are possible. information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Decreased appetite, Illness, Nausea
Clinical narrative: achy joints; chills; fever; nausea; no appetite; Would like to know why she was sick for so long; This is a spontaneous report from a Pfizer sponsored program from a non contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included she was sick at the beginning of the pandemic from an unknown date. Patient previously took bnt162b2 (Pfizer Covid-19 Vaccine, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced marginal side effects. The patient concomitant medications were not reported. On an unspecified date, the patient experienced achy joints, chills, fever, nausea, no appetite, she was sick for so long. The clinical outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: achy joints; chills; fever; nausea; no appetite; Would like to know why she was sick for so long; This is a spontaneous report from a Pfizer sponsored program from a non contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (Pfizer Covid-19 Vaccine, solution for injection, Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunisation. Medical history included she was sick at the beginning of the pandemic from an unknown date. Patient previously took bnt162b2 (Pfizer Covid-19 Vaccine, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization and experienced marginal side effects. The patient concomitant medications were not reported. On an unspecified date, the patient experienced achy joints, chills, fever, nausea, no appetite, she was sick for so long. The clinical outcome of the events was reported as unknown.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea, Pyrexia, Urticaria, Vomiting
Clinical narrative: fatigue; minor fever; nausea; vomiting; hives returned on both hands and feet; This is a spontaneous report received from a contactable consumer. This 51-year-old consumer (patient) reported for herself that,  A female patient of 51-year-old received bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot Number: EN6200) (at the age of 51 year old), dose 2 intramuscular, administered in deltoid right on 17Feb2021 08:00 as dose 2, single for covid-19 immunisation. Historical vaccine, the patient took first dose bnt162b2 (BNT162B2, Formulation: Solution for injection, Batch/Lot number: EN5318), dose 1 intramuscular, administered in deltoid right on 30Jan2021 08:00 as dose 1, single for covid-19 immunisation, the patient experienced, Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it)/Swell occurred 5 days post injection and remained for several days and Very enlarged lymph nodes on right, backside of neck up to the ear (1 protruding quarter sized, with little lumps above it) with corresponding ear ache and rough throat. Medical history included, psoriatic arthropathy from an unknown date and unknown if ongoing, systemic lupus erythematosus from Jun2019 to an unknown date Onset date: 10 years  Pertinent details: Onset after a reaction to a biologic (Humera), benzodiazepine derivatives from 2007 to an unknown date. Concomitant medication(s) included guselkumab (TREMFYA) taken for an unspecified indication from an unspecified start date and ongoing. It was reported on an unspecified date patient experienced fatigue, minor fever, nausea, vomiting on day 3 and hives returned on both hands and feet. The outcome for the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 1st dose from a different facility on 21Apr2021 and she is experiencing fever for the past 4 days.; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for herself.   A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH covid-19 mRna vaccine, solution for injection), dose 1 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the patient received first dose from a different facility on 21Apr2021 and she experienced fever for the past 4 days on unknown date in Apr2021. Her 17 years old son was to receive the 2nd dose of vaccine tomorrow on 05May2021. She asked for the phone number of the facility because she misplaced the calling card for it. She doesn't remember when her son received the 1st dose (might missed second dose). At the time of this report, the outcome of event was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Rash
Clinical narrative: I had rash on both arms and later spread to both of my legs; Sore Arm; This is a spontaneous report from a contactable consumer (reported for himself). A 72-year-old male patient received first dose of BNT162B2 (BNT162B2, Solution for injection, Lot number: EW0172), via an unspecified route of administration on 29Apr2021 as dose 1, single (at the age of 72-year-old) for COVID-19 immunization. Medical history included hypertension from an unknown date and unknown if ongoing, prostate cancer from an unknown date and unknown if ongoing (patient took medication for prostate). Concomitant medications included lisinopril and amlodipine, both taken for hypertension, start and stop date were not reported; dutasteride and tamsulosin, both taken for an unspecified indication, start and stop date were not reported. On 30Apr2021 (also reported as Friday about mid-morning), the patient started getting sore arm and that lasted for a day but that was not for patient was calling. On 01May2021 (also reported as Yesterday morning), the patient looked at his arms and had a rash on both arms and later in the afternoon, it spread to both of his legs, unusual side effects. Treatment was not received for events. No la tests since January. Patient called because people gave him the vaccine said him that if he had any unusual side effects, he had to let them know because may be he can't take the second shot. So he needed to get the answer to that that question should he keep his appointment to the 20May or not keep it. Seriousness for events was not specified. Outcome of the events was not recovered.   No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Feeling hot, Feeling of body temperature change
Clinical narrative: Second dose: chills; Second dose: muscle aches in his knees; Second dose: warm and cold at the same time; Second dose: throwing up; Second dose: constant headache; Second dose: he's not really eating either, he's not that hungry; Second dose: he was hot; Second dose: fever; This is a spontaneous report from a contactable consumer (patient's mother) reported for her son (patient).  A 16-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER2613, Expiry date: not reported), via an unspecified route of administration, administered in left arm on 03May2021 at 17:15 (Age at vaccination: 16-years-old) as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER2613, Expiry date: not reported), via an unspecified route of administration, administered in left arm on 12Apr2021 at 16:30 (Age at vaccination: 16 years old) as dose 1, single for covid-19 immunization and Patient's mother reported patient was a little tired and had a tiny bit of soreness in his arm at the injection site. Patient's mother thought the soreness in his arm was because he doesn't like to get shots and doesn't like needles. With the first dose, his side effects started the day after receiving the first vaccine on 13Apr2021. His side effects only lasted that day on 13Apr2021, by the next day, 14Apr2021, he was fine. Patient received his second Covid 19 vaccine yesterday, 03May2021. There was no prior vaccination within 4 weeks, no additional vaccines administered. Patient didn't have that bad a reaction with the first Covid 19 vaccine, but for second dose patient had fever and chills at the same time. On 04May2021 He had muscle aches in his knees and that's weird. He was a little warm last night after he received the vaccine, patient's mother thought it was nothing. This morning, 04May2021, he was a little warm. Patient went to school, and she received a call from his school that he was feeling warm and cold at the same time. His temperature was taken at school today, 04May2021, and he didn't have a fever, but he is throwing up. Patient came home after getting his second Covid 19 vaccine, ate dinner, and later on that night on 03May2021 he said he was hot. He was also having headaches. He has a constant headache. Patient's mother reported that he doesn't ever really get sick. Patient's mother reported that he's not really eating either, he's not that hungry. That started today, 04May2021 because he did eat dinner last night, 03May2021. Events didn't required visit to physician office or emergency room. Outcome of the event fever was unknown and for all events outcome was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pyrexia, Vomiting
Clinical narrative: Second dose: chills; Second dose: muscle aches in his knees; Second dose: warm and cold at the same time; Second dose: throwing up; Second dose: constant headache; Second dose: he's not really eating either, he's not that hungry; Second dose: he was hot; Second dose: fever; This is a spontaneous report from a contactable consumer (patient's mother) reported for her son (patient).  A 16-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER2613, Expiry date: not reported), via an unspecified route of administration, administered in left arm on 03May2021 at 17:15 (Age at vaccination: 16-years-old) as dose 2, single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER2613, Expiry date: not reported), via an unspecified route of administration, administered in left arm on 12Apr2021 at 16:30 (Age at vaccination: 16 years old) as dose 1, single for covid-19 immunization and Patient's mother reported patient was a little tired and had a tiny bit of soreness in his arm at the injection site. Patient's mother thought the soreness in his arm was because he doesn't like to get shots and doesn't like needles. With the first dose, his side effects started the day after receiving the first vaccine on 13Apr2021. His side effects only lasted that day on 13Apr2021, by the next day, 14Apr2021, he was fine. Patient received his second Covid 19 vaccine yesterday, 03May2021. There was no prior vaccination within 4 weeks, no additional vaccines administered. Patient didn't have that bad a reaction with the first Covid 19 vaccine, but for second dose patient had fever and chills at the same time. On 04May2021 He had muscle aches in his knees and that's weird. He was a little warm last night after he received the vaccine, patient's mother thought it was nothing. This morning, 04May2021, he was a little warm. Patient went to school, and she received a call from his school that he was feeling warm and cold at the same time. His temperature was taken at school today, 04May2021, and he didn't have a fever, but he is throwing up. Patient came home after getting his second Covid 19 vaccine, ate dinner, and later on that night on 03May2021 he said he was hot. He was also having headaches. He has a constant headache. Patient's mother reported that he doesn't ever really get sick. Patient's mother reported that he's not really eating either, he's not that hungry. That started today, 04May2021 because he did eat dinner last night, 03May2021. Events didn't required visit to physician office or emergency room. Outcome of the event fever was unknown and for all events outcome was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Headache, Pyrexia
Clinical narrative: Woke up with a headache; Chills; Low grade fever; Start cough a little bit; This is spontaneous report received from a contactable consumer (patient) reported for himself that:  A 27-years-old male patient received BNT162B2 (BioNTech/Pfizer vaccine solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 01May2021 (Batch/Lot Number: ER8786) as DOSE 2, SINGLE for covid-19 immunization (Age at vaccination 27 years). The patient past medical history included Blood pressure high from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient received the first 1st dose of COVID-19 Vaccine via an unspecified route of administration, administered in Arm Left 08Apr2021(Batch/Lot Number: EW0150 as DOSE 1, SINGLE for covid-19 immunization. Consumer stated, I am having some side effects after taking the 2nd dose of Pfizer today I woke up with a headache, I got chills and I have low grade fever and I have start cough a little bit on an unspecified date. No treatment was received. The event outcome was unknown for all the events.  No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash all over body; This is a spontaneous report from a contactable consumer. This consumer (patient's daughter) reported (reporter's mother) that:  A 80-years-old female patient received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration, administered in Arm on 20Feb2021 15:00 (At the age of 80 years) as DOSE 2,SINGLE for covid-19 immunisation. The patient medical history was not reported. Patient was allergic to penicillin from an unknown date and unknown if ongoing. Patient had not taken any prior vaccination within 4 weeks. The patient's concomitant medications were not reported. On unspecified date, patient previously received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: was not reported), via an unspecified route of administration (At the age of 80 years) as DOSE 1, SINGLE for covid-19 immunisation.The patient experienced rash all over body on an unspecified date. At the time of reporting, the outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Nasal congestion, Pyrexia
Clinical narrative: Fever; congestion; got sick with flu; This is a spontaneous report from a contactable consumer (husband). A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via an unspecified route of administration on an unspecified date (at the age of 35-year-old) as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient got sick with flu, fever and congestion on Tuesday of last week (27Apr2021). She will be having her second dose. Wanted to know if it was okay to take the vaccine on Wednesday. The outcome of all events was unknown.  No follow-up attempts are needed. No further information is expected.