chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Vision blurred
Clinical narrative: The one on May 5th he had quite a bit of reaction, the achy muscles, headache, nausea and even a little bit of the blurry vision; The one on May 5th he had quite a bit of reaction, the achy muscles, headache, nausea and even a little bit of the blurry vision; The one on May 5th he had quite a bit of reaction, the achy muscles, headache, nausea and even a little bit of the blurry vision; The one on May 5th he had quite a bit of reaction, the achy muscles, headache, nausea and even a little bit of the blurry vision; This is a spontaneous report received from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 05May2021 as 1st dose, single dose and received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 27May2021 as 2nd dose, single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient's wife stated that her husband and she herself received the Pfizer Vaccine, their first one on 05May2021 and second one on 27May2021. Now her husband when had the one on 05May2021 he had, quite a bit of reaction, the achy muscles headache nausea and even a little bit of the blurry vision. And within a day, she would say probably in 2 days he was feeling better. Now on the 27May2021, the second dose that they got, he had a little bit less the first couple of days achy muscles but it then, they were going on 11 days now since that shot and today (07Jun2021) he is starting to feel very nauseated, achy muscles again, headache chills. The outcome of the events was recovering.   Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Nausea
Clinical narrative: The second dose, he had a little bit less the first couple of days achy muscles, 11 days now since that shot and today he is starting to feel very nauseated, achy muscles again, headache, chills; The second dose, he had a little bit less the first couple of days achy muscles, 11 days now since that shot and today he is starting to feel very nauseated, achy muscles again, headache, chills; The second dose, he had a little bit less the first couple of days achy muscles, 11 days now since that shot and today he is starting to feel very nauseated, achy muscles again, headache, chills; The second dose, he had a little bit less the first couple of days achy muscles, 11 days now since that shot and today he is starting to feel very nauseated, achy muscles again, headache, chills; This is a spontaneous report from a contactable consumer or other non-healthcare professional.   A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on 27May2021, as a single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Historical vaccine given to patient previously was dose 1 received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05May2021, as a single dose for COVID-19 immunisation and had achy muscles, headache, nausea and even a little bit of the blurry vision. It was reported that patient and reporter both received the Pfizer vaccine, they received first dose on 05May2021, and the second one on 27May2021. On 27May2021, after the second dose, the patient had a little bit less the first couple of days achy muscles but it then, they are going on 11 days, since that shot and today, he started to feel very nauseated, achy muscles again, headache, chills. The reported asked "Is that a normal thing even after 11 days after the shot. The outcome of the events was reported as not recovered.  Information on the lot/batch number has been requested
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Chills, Heart rate increased, Pyrexia
Clinical narrative: discomfort chest pain; rapid heart rate; fever; chills; This is a spontaneous report from a contactable consumer (patient). This 14-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EW0180), via an unspecified route of administration on 04Jun2021 into left arm as a 2nd dose, single dose for covid-19 immunization. The medical history and concomitant medications were not reported. Historical vaccine includes first dose of BNT162B2 (lot number: EW0182) on 14May2021 in to left arm for covid-19 immunization and experienced discomfort chest pain on 08Jun2021. The patient reported, he had fever and chills, but those went away. He has experienced not severe chest pain, but discomfort chest pain. And for the past few days, he had a rapid heart rate. The first day he got his second dose, he took some Ibuprofen but that's really about it. He states well he's sitting down so he's not having it anymore but when he stands up or is in a weird position, it kind of comes back. States it's about the same, caller confirms its persisting. Prior to vaccination (within 4 weeks), the patient was not diagnosed with COVID-19. The outcome of the events was not recovered for discomfort chest pain, unknown for rapid heart rate and recovered for rest all the events.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Gait disturbance, Mobility decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: Its beginning to show has side effect pain in arm some of it got; Its beginning to show has side effect pain in arm some of it got; most part of muscle pain, so the pain is real bad; he really can't walk very well; Its beginning to show has side effect pain in arm some of it got; most part of muscle pain, so the pain is real bad; he really can't walk very well; This guy is really in pain, he have the bad muscle pain in his arm and it's like the unbearable pain; he can't even move his arm right now; This guy is really in pain, he have the bad muscle pain in his arm and it's like the unbearable pain; he can't even move his arm right now; This is a spontaneous report from a contactable consumer. This consumer reported for a patient (reporter's uncle), that a male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8737, Expiry Date: Unknown), via an unspecified route of administration on 07JUN2021 as an UNKNOWN, SINGLE DOSE for COVID-19 immunisation. Patient's medical history and concomitant medications were not reported. Reporter mentioned that, took just got the vaccine today Its beginning to show had side effect pain in arm some of it got; (on 07JUN2021) most part of muscle pain, so the pain was real bad; and reporter was afraid since, patient really can't walk very well. He also mentioned that this guy was really in pain, he had the bad muscle pain in his arm and it was like the unbearable pain; he can't even move his arm right now (date unspecified). Reporter further stated that, "And reporter don't hear some would do at this point and this guy (patient) was really in pain he don't know he drove back to car, what he can do to relieve the pain because he had the bad muscle pain in his arm and It was like the unbearable pain, he knew it was part of the symptoms when you get shot but he didn't know how hard the symptoms will be before he got the help or way need to see the help. Reporter asked So what he was supposed to do he was pain how to handle that he was in pain, and he don't know what to do. Reporter seriousness for the events was Unspecified. Outcome of all the events were Not resolved.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Magnetic resonance imaging, X-ray
Clinical narrative: I began experiencing swelling around bone on outside of left wrist bone and after that increasing pain in that area and around the thumb on same hand. After x-ray and MRI on that hand confirmed arthri; This is a spontaneous report from a contactable consumer. A 81-years-old male consumer (patient) reported for himself that he received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: EL9264) via an unspecified route of administration on 13Feb2021 at 11:45 in left arm as a single dose for covid-19 immunization at hospital. Medical history included arthritis in neck, psoriasis and irritable bowel syndrome all from an unknown date and unknown if ongoing, left knee replacement in 2014. The patient previously took celebrex for drug hypersensitivity. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient had not been tested for COVID-19. The patient historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine; Lot Number: EL3249) on 23Jan2021 at 10:00 in left arm for COVID-19 immunization. Concomitant medications received in two weeks included finasteride (FINASTERIDE), gabapentin (GABAPENTIN), levothyroxine (LEVOTHYROXINE) and magnesium (MAGNESIUM) all taken for an unspecified indication, start and stop date were not reported. On an unspecified date in Mar2021, the patient experienced swelling around bone on outside of left wrist bone and after that pain increased in that area and around the thumb on same hand. X-ray and MRI confirmed arthritis that hadn't been evident before Covid-19 jabs. He also experienced some pain in left elbow and outside bone on right wrist and left hip bone discomfort had intensified into sharp pain at times. Bone density test showed normal range. Therapeutic measures were taken, and patient was treated with steroid injection in left wrist (zero help). The patient underwent lab tests and procedures which included magnetic resonance imaging and x-ray which confirmed arthritis and bone density test showed normal range. The events resulted in Doctor or other healthcare professional office/clinic visit. The outcome of the event was not recovered.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Blood cholesterol, Burning sensation, Chest pain, Restlessness
Clinical narrative: Chest pain in the upper right chest; Restlessness; Upper right shoulder pain; burning sensation; This is a spontaneous report from a contactable consumer (patient). This is Report 1 of 2. A 52-years-old male patient received second dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection; Lot number: EW0179, expiration date: unknown), via an unspecified route of administration, administered in right upper arm on 20May2021 as 2nd dose, single dose; and previously took first dose of BNT162B2(Lot number: EW0172), via an unspecified route of administration, administered in left upper arm on 29Apr2021 as 1st dose, single dose for COVID-19 immunization. Medical history included Depression diagnosed at 4 years old as he was adopted and everything, and had Previously heart attack on 23Oct2003, high cholesterol, and a finger cut off. Patient states it was work related and accidental, he put his hand in the wrong spot, the actuator came down, and took his finger off. States that was years ago, they were able to stitch it back on. Patient reported him and his wife are allergic to cottonwood and he don't know what treatment to take. Patient also reported after forty there is two things that happen, one you start losing your memory, and second you can not remember the other one, and that is exactly what happened to him. Concomitant medications included FLUOXETINE, 40 mg, 2 capsules once a day, every morning, he thinks he takes for cholesterol; ATORVASTATIN, 20 mg daily, he thinks he takes for depression; AMITRIPTYLINE HCL, 25 mg. Takes 3 at night which helps him sleep; LISINOPRIL, 20 mg tablet once daily, taken for an unspecified indication; since 1.5 years and start and stop date of all concomitant medications were not reported. No prior Vaccinations within 4 weeks of vaccination. The patient on an unknown date in May2021, woke up in the middle of the night, he was experiencing restlessness, and not really chest pain, almost like a shoulder pain, up in the shoulder, not like a heart attack or anything and chest pain in the upper right chest which is bearable, but annoying. Patient stated pain comes and goes. Chest pain is still persisting, and started about 2-3 days of second vaccination and has not improved, it is still steady, a burning sensation, and always in the upper right shoulder, above the male breast, up above that, up in the clavicle. The patient underwent lab tests and procedures which included blood cholesterol: only two points up. No investigation assessment. No Emergency Room or Physician Office visits. The outcome of chest pain in the upper right chest was not recovered, upper right shoulder pain was recovering; restlessness and burning sensation was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Hypersensitivity, Lymphadenopathy, Malaise, Nausea
Clinical narrative: Respiratory reaction right away; Sore throat; Swollen glands; Nauseous; Sick; lungs ached; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 04Jun2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for COVID-19 immunisation. The patient received her second dose of the Pfizer COVID 19 Vaccine Friday (04Jun2021) afternoon and very shortly after getting the vaccine she got sick. Friday night (04Jun2021) her lungs ached, and she had never felt like that before in her life. She stated she definitely had a respiratory reaction right away; sore throat, swollen glands, and she felt nauseous. She had difficulty breathing last night (Jun2021). The patient was still sick and its a little concerning with some of the things she had experienced over the past few days. She wanted to know if she should go to a health care professional and wanted to know what she should do. The patient was advised that she should contact her HCP. Outcome of event sick was not recovered and other events was unknown.  Information about lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pulmonary pain
Clinical narrative: Respiratory reaction right away; Sore throat; Swollen glands; Nauseous; Sick; lungs ached; difficulty breathing; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration on 04Jun2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) for COVID-19 immunisation. The patient received her second dose of the Pfizer COVID 19 Vaccine Friday (04Jun2021) afternoon and very shortly after getting the vaccine she got sick. Friday night (04Jun2021) her lungs ached, and she had never felt like that before in her life. She stated she definitely had a respiratory reaction right away; sore throat, swollen glands, and she felt nauseous. She had difficulty breathing last night (Jun2021). The patient was still sick and its a little concerning with some of the things she had experienced over the past few days. She wanted to know if she should go to a health care professional and wanted to know what she should do. The patient was advised that she should contact her HCP. Outcome of event sick was not recovered and other events was unknown.  Information about lot/batch number has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Antinuclear antibody, Cough, Malaise, Muscular weakness, Pain in extremity
Clinical narrative: Extreme weakness in her arms and legs; Really bad cough; painful in arms and legs; not been feeling well; This is a spontaneous report received from a contactable consumer (Parent). A 14-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration in right shoulder on 23May2021 14:00 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. Family history was reported as none, they were basically a healthy family. Patient was not vaccinated within 4 weeks and no additional Vaccines administered on same Date of the Pfizer Suspect. On 23May2021, the patient experienced extreme weakness in her arms and legs, really bad cough, on an unspecified date in May2021, she had severe pain in her legs and on an unspecified date in 2021, she was not been feeling well. Patient's father called on behalf of his 14-year-old daughter who received the first dose of the Pfizer COVID-19 vaccine about two weeks ago and had extreme weakness in arms and legs, 2 weeks ago, on Sunday 23May2021. She had not been to school since then, she went for a couple hours and then they send her back. His daughter also said that it had been painful but caller states that he does not know exactly what his daughter means by that, she said that her legs hurt her, that started probably 24May2021 or 25May2021 with the bad cough also and not been feeling well. Had all leveled out the past 10 days. Had blood work and the results came back Friday. Thought there was an outside chance based on the blood work that it was strep related. Her doctor had suggested that the parents call Pfizer to see if this type of reaction had been reported in her age group after receiving the Pfizer COVID-19 vaccine. She never really had a fever. This started the day after the vaccine, and they are not sure if it was related to the vaccine or not. A couple of results were off. The Streptolysins were 468. The antinuclear antibodies were 1 to 160, which was off. Everything else was negative. The patient underwent lab tests and procedures which included antinuclear antibody: 1 to 160, streptococcus test: 468. Patient received therapeutic measure to treat adverse events, they tried Amoxicillin, which had no impact, they thought maybe it was just a virus. They also tried Tylenol and Advil, which also had no impact. Stated that the Amoxicillin was 875mg twice a day and that the Tylenol and Advil were from different packages lying around the house. Patient was scheduled for the second dose this coming Sunday but they were holding off until she was better. The outcome of events was unknown.    Information on the lot/batch number has been requested.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Streptococcus test
Clinical narrative: Extreme weakness in her arms and legs; Really bad cough; painful in arms and legs; not been feeling well; This is a spontaneous report received from a contactable consumer (Parent). A 14-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, via an unspecified route of administration in right shoulder on 23May2021 14:00 (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. Medical history was reported as none. There were no concomitant medications. Family history was reported as none, they were basically a healthy family. Patient was not vaccinated within 4 weeks and no additional Vaccines administered on same Date of the Pfizer Suspect. On 23May2021, the patient experienced extreme weakness in her arms and legs, really bad cough, on an unspecified date in May2021, she had severe pain in her legs and on an unspecified date in 2021, she was not been feeling well. Patient's father called on behalf of his 14-year-old daughter who received the first dose of the Pfizer COVID-19 vaccine about two weeks ago and had extreme weakness in arms and legs, 2 weeks ago, on Sunday 23May2021. She had not been to school since then, she went for a couple hours and then they send her back. His daughter also said that it had been painful but caller states that he does not know exactly what his daughter means by that, she said that her legs hurt her, that started probably 24May2021 or 25May2021 with the bad cough also and not been feeling well. Had all leveled out the past 10 days. Had blood work and the results came back Friday. Thought there was an outside chance based on the blood work that it was strep related. Her doctor had suggested that the parents call Pfizer to see if this type of reaction had been reported in her age group after receiving the Pfizer COVID-19 vaccine. She never really had a fever. This started the day after the vaccine, and they are not sure if it was related to the vaccine or not. A couple of results were off. The Streptolysins were 468. The antinuclear antibodies were 1 to 160, which was off. Everything else was negative. The patient underwent lab tests and procedures which included antinuclear antibody: 1 to 160, streptococcus test: 468. Patient received therapeutic measure to treat adverse events, they tried Amoxicillin, which had no impact, they thought maybe it was just a virus. They also tried Tylenol and Advil, which also had no impact. Stated that the Amoxicillin was 875mg twice a day and that the Tylenol and Advil were from different packages lying around the house. Patient was scheduled for the second dose this coming Sunday but they were holding off until she was better. The outcome of events was unknown.    Information on the lot/batch number has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Migraine, Neck pain, Pyrexia
Clinical narrative: also been experiencing a migraine which doesn't seem to be going away/ Intractable migraine, pain in his head; pain in his head and neck; Fever; chills; This is a spontaneous report from a contactable consumer (patient's mother). A 16-years-old male patient received second dose of bt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0181), via an unspecified route of administration, administered in deltoid left on 04Jun2021 at 10:25 (at the age of 16-years-old) as single dose for COVID-19 immunization. The patient did not had ant medical history. The patient's concomitant medications were not reported. The patient previously received the first dose of bt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: EW0182), administered in left deltoid muscle on 14May2021 as single dose for COVID-19 immunization. The patient did not receive any other vaccine within four weeks prior to the first administration date of the suspect vaccine. The patient did not administer any additional vaccines on same date of the Pfizer suspect. On 04Jun2021 at 18:25 (within 8 hours of being administered the second dose of Pfizer Covid-19 Vaccine), the patient experienced fever and chills. On 05Jun2021 at 20:00, the patient been experiencing a migraine which doesn't seem to be going away/ intractable migraine, pain in his head, and pain in his neck. The patient received treatment for the fever and chills which included Tylenol. The patient was also treated for the migraine and pain in his head and neck. Duration of the fever and chills was about 36 hours, after which patient recovered completely. The consumer explained that the fever and chills were the normal, expected side effect. The intractable migraine, pain in head and neck was persistent. The patient did not require a visit to emergency room or physician office but they were waiting to hear back from his doctor. The patient was not hospitalized and did not underwent relevant tests. The consumer wanted to know if that was normal and how long she should expect the headache to last. The outcome of the events fever and chills was resolved on 06Jun2021, and migraine and pain in his head and neck was not resolved.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: Fever; She woke up before 6 in the morning feeling bad; when she stand up she felt weak; She woke up before 6 in the morning feeling bad; when she stand up she felt weak; This is a spontaneous report from a contactable consumer (patient's mother). A 12-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on 07Jun2021 14:45 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had received other products. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) on 17May2021 for COVID-19 immunization. Reporter stated, Exactly 3 weeks before second dose patient took 1st dose of vaccine. Reporter stated that, On 08Jun2021 patient woke up before 6 in the morning feeling bad and she had a fever and so they gave her Ibuprofen an hour ago and currently she still had the fever over 101 and she still feeling pretty badly like she did not like when she stand up she felt weak. Reporter was just wondering at what point they should get an alarmed the sheet said that a fever was a side effect but like at what point for a fever should be they worried; she enquired. Reporter further added, 'The sheet she received says that if experience severe reaction Call 911 but it's hard to know what is severe reaction is, you know. Reporter was informed about Pfizer Medical information department and was provided with the number. Therapeutic measures were taken as a result of fever, she woke up before 6 in the morning feeling bad; when she stand up she felt weak, she woke up before 6 in the morning feeling bad; when she stand up she felt weak as Ibuprofen was given to patient. The outcome of all events was unknown.  Information on Lot/Batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Influenza, Insomnia, Nausea
Clinical narrative: feels that his "heart rate is higher than normal; the minor symptoms a person gets with the flu; pain in the arm; Typical Tiredness; nausea; difficulty sleeping and getting rested, he feels like he is trying to sleep; This is a spontaneous report from a contactable consumer. This 63-year-old male patient reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0180) via an unspecified route of administration on 01Jun2021 at 18:00 hours (at 63-years-old) on left arm as 2nd dose, single dose for COVID-19 immunization. Medical history of the patient included ongoing high blood pressure for over 20 years. The concomitant medications of the patient included losartan at a dose of 100 mg, 1x/day, amlodipine at a dose of 5 mg, 1x/day and hydrochlorothiazide at a dose of 12.5 mg, 1x/day, the patient had been taking these for at least 20 years for high blood pressure. Historical vaccine of the patient included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0182) via an unspecified route of administration on 11May2021 (at 63-years-old) on left arm as 1st dose, single dose for COVID-19 immunization. The caller mentioned that he does not recall getting any vaccines as an adult, but his parents had him vaccinated as a child. It was mentioned that the patient did not require visit to emergency room and physician office and prior vaccinations within 4 weeks were reported as none. On 01-Jun-2021, the same day the patient experienced typical side effects of pain in the arm, tiredness, nausea. The patient also has difficulty sleeping as well as feels that his heart rate was higher than normal. Caller was asking if similar side effects have been reported. The patient states he is calling about his Second Shot of the Pfizer BioNTech Covid Vaccine. He had it a week ago and he is still having a side effect from it, it was on Tuesday a week ago from today. Caller states the main side effects are he feels like he has a rapid heart beat and he has difficulty sleeping and getting rested, he feels like he is trying to sleep at grand central station, his body won't rest. Caller asking if anyone else has reported symptoms similar to this. The treatment received was reported as none, the patient wanted to wait and see if they would go away.  On 02Jun2021 the event of typical tiredness, nausea and the minor symptoms a person gets with the flu recovered. On 03Jun2021 the event of pain in the arm recovered. The event of difficulty sleeping and getting rested, he feels like he is trying to sleep and feels that his heart rate is higher than normal had not recovered.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: feels that his "heart rate is higher than normal; the minor symptoms a person gets with the flu; pain in the arm; Typical Tiredness; nausea; difficulty sleeping and getting rested, he feels like he is trying to sleep; This is a spontaneous report from a contactable consumer. This 63-year-old male patient reported for herself that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0180) via an unspecified route of administration on 01Jun2021 at 18:00 hours (at 63-years-old) on left arm as 2nd dose, single dose for COVID-19 immunization. Medical history of the patient included ongoing high blood pressure for over 20 years. The concomitant medications of the patient included losartan at a dose of 100 mg, 1x/day, amlodipine at a dose of 5 mg, 1x/day and hydrochlorothiazide at a dose of 12.5 mg, 1x/day, the patient had been taking these for at least 20 years for high blood pressure. Historical vaccine of the patient included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0182) via an unspecified route of administration on 11May2021 (at 63-years-old) on left arm as 1st dose, single dose for COVID-19 immunization. The caller mentioned that he does not recall getting any vaccines as an adult, but his parents had him vaccinated as a child. It was mentioned that the patient did not require visit to emergency room and physician office and prior vaccinations within 4 weeks were reported as none. On 01-Jun-2021, the same day the patient experienced typical side effects of pain in the arm, tiredness, nausea. The patient also has difficulty sleeping as well as feels that his heart rate was higher than normal. Caller was asking if similar side effects have been reported. The patient states he is calling about his Second Shot of the Pfizer BioNTech Covid Vaccine. He had it a week ago and he is still having a side effect from it, it was on Tuesday a week ago from today. Caller states the main side effects are he feels like he has a rapid heart beat and he has difficulty sleeping and getting rested, he feels like he is trying to sleep at grand central station, his body won't rest. Caller asking if anyone else has reported symptoms similar to this. The treatment received was reported as none, the patient wanted to wait and see if they would go away.  On 02Jun2021 the event of typical tiredness, nausea and the minor symptoms a person gets with the flu recovered. On 03Jun2021 the event of pain in the arm recovered. The event of difficulty sleeping and getting rested, he feels like he is trying to sleep and feels that his heart rate is higher than normal had not recovered.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammatory marker decreased, Inflammatory marker test, Therapeutic response unexpected
Clinical narrative: Some of her symptoms started to dissipate and her inflammation markers are coming down/unexpected benefit: inflammation markers have started to come down and symptoms are starting to dissipate; Some of her symptoms started to dissipate and her inflammation markers are coming down/unexpected benefit: inflammation markers have started to come down and symptoms are starting to dissipate; This is a spontaneous report from a contactable consumer (Husband). Follow-up received on 08Jun2021 from a contactable consumer was processed together along with initial information.   A 60-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER2613, Expiration date: unspecified), via unspecified route, administered in right arm on 23Mar2021 02:40pm (at the age of 60-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history includes rheumatoid arthritis and covid-19 positive in Jan2020. It was reported that before getting covid, her hands would sweat, but after having covid they stopped sweating. Concomitant medications include Prednisolone which started from Jan2021 and started with a dose of 15mg which is then reduced to 10mg and 5 mg. Lab investigation includes inflammatory markers which is 2 on unspecified date and 0.8 on unspecified date. History of all previous immunization with the Pfizer is none. On an unspecified date in Mar2021, after the vaccination, the patient had unexpected benefit where her inflammation markers have started to come down and her symptoms are starting to dissipate. The inflammation markers started going down after the first Pfizer vaccine. She had an appointment with her doctor at the end of the month. Her marker level was 2 then it went down to 0.8. Caller reported an unexpected benefit from the Pfizer Covid vaccine. She usually has a lot of inflammation of her joints and typically had sweaty hands. After her covid infection in jan2020 her sweating in hand stopped. Because of the joint inflammation she was tested for rheumatoid arthritis which was negative. After second dose the doctor wants to start her on Xeljanz still thinking it is RA but before she does, she needs to get her Shingrix vaccines. All his family got the Pfizer covid vaccine and no one had any major side effects. Reporter also asked about whether the prednisone reduce the efficacy of the vaccine. The events did not result in emergency room/physician office visit. And Will being on Xeljanz reduce the efficacy of the vaccine. The outcome of event was unknown.      Follow-up attempts are needed. Further information is requested.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Peripheral swelling, Pruritus, Vaccination site swelling
Clinical narrative: a little swollen little knot under her arm and it's sore; a little swollen little knot under her arm and it's sore; she had swelling where she got the shot; itching; under arm is swollen its like a little knot in there and its sore/swollen lymph nodes under the arm; This is a spontaneous report from a contactable consumer (patient). A female 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 an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. The patient experienced a little swollen little knot under her arm and it's sore, she had swelling where she got the shot and it just kept getting bigger and bigger and it was itching, and swollen arms and swollen lymph nodes under the arm on an unspecified date. She asked regarding to put ice or heat on it. She also already consulted her doctor and was advised to take Tylenol. Outcome of all the events were unknown.Information about lot/batch number cannot be obtained.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Bone disorder, Hypoaesthesia, Pain in extremity, Scab
Clinical narrative: Funny bone feeling on the whole arm; He had pain on the whole left arm and left shoulder; He had pain on the whole left arm and left shoulder; Numbness; He had a scab, on his left arm.; Almost like its trying to fall asleep; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient himself). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on Feb2021 as 2nd dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient didn't had any reactions. The patient previously took first dose of BNT162B2 on Jan2021 via unspecified route of administration for COVID-19 immunisation and experienced no reaction on previous exposure to vaccine. On an unspecified date, the patient experienced that he had the following side effects in his left arm, which is the arm that received the injection: funny bone feeling on the whole arm, at the site of injection, it felt like his shirt was snagging on something, and noticed he had a scab, on his left arm later on he had pain on the whole left arm and left shoulder. He stated that it was almost like its trying to fall asleep. Some pain related but mostly kind of a numbness. Patient stated that a search of the PI contains no information regarding his side effects as being reported from the vaccine. The clinical outcome for the events was reported as unknown.  Follow-up attempts are needed; Information on the lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Funny bone feeling on the whole arm; He had pain on the whole left arm and left shoulder; He had pain on the whole left arm and left shoulder; Numbness; He had a scab, on his left arm.; Almost like its trying to fall asleep; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient himself). A 74-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported) via an unspecified route of administration on Feb2021 as 2nd dose, single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Patient didn't had any reactions. The patient previously took first dose of BNT162B2 on Jan2021 via unspecified route of administration for COVID-19 immunisation and experienced no reaction on previous exposure to vaccine. On an unspecified date, the patient experienced that he had the following side effects in his left arm, which is the arm that received the injection: funny bone feeling on the whole arm, at the site of injection, it felt like his shirt was snagging on something, and noticed he had a scab, on his left arm later on he had pain on the whole left arm and left shoulder. He stated that it was almost like its trying to fall asleep. Some pain related but mostly kind of a numbness. Patient stated that a search of the PI contains no information regarding his side effects as being reported from the vaccine. The clinical outcome for the events was reported as unknown.  Follow-up attempts are needed; Information on the lot/batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site vesicles, Rash macular
Clinical narrative: she noticed a "bright red blotchy spot" where she received the vaccine; she noticed a "bright red blotchy spot" where she received the vaccine; her arm got a big red spot/blotch; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN0167, Expiration date: Unknown), via an unspecified route of administration in the left arm, on 04Jun2021 at 14:30 (at the age of 50-year-old) as 2 ND DOSE, SINGLE DOSE for COVID-19 immunisation. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8730, Expiration date: Unknown), via an unspecified route of administration in the left arm, on 12May2021 (at the age of 50-year-old) as 1 ST DOSE, SINGLE DOSE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. History of all previous immunization with the Pfizer vaccine considered as suspect was unknown.  Additional vaccines administered on same date of the pfizer suspect was none. Prior vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. The patient started that she got the vaccine, both of them, and nothing happened for the first couple days. On 06Jun2021, the patient experienced bright red blotchy spot and the area where it was red and blotchy had some warmth to it. The patient stated that she did not have this type of side effect when she received her first dose. She also reported that when the pharmacist gave her second dose of injection, he squeezed her arm and she was not sure if this was what could have caused her arm to get red at the injection site or if the redness was a possible side effect from the vaccine. She stated that she got the second vaccine on friday at walgreens and the location she received the vaccination was fine, until a day later. She stated that she thinks on Sunday her arm got a big red spot and she does not know if it was from him holding/squeezing her arm and then giving the shot and releasing her arm. She stated that there is one big red blotch on her arm now and she is trying to see if that is normal. The caller states that there is nothing else is going on with her but she wants to make sure that nothing happens as a result of this. She also stated that she did not felt sick or anything and she had no side effects with her first shot so she just wanted to know if this could be a side effect or not. The patient stated that there was nothing else was going on with her but she wanted to make sure that nothing happens as a result of this. The patient treatment was not provided. The outcome of the events injection site erythema and injection site blisters was unknown. The outcome of the event macular rash was not recovered.  Information about lot/batch number is available. Follow-up attempts are needed
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hypoaesthesia oral, Insomnia, Nerve compression, Pain
Clinical narrative: chills; I woke on and off; feeling achy and feverish; feeling achy and feverish; Also I bit my tongue; she feels her tongue acting like its weird/ Its like acting weird, she feels like its numb, not flexible; Ache; Pinch; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 05Jun2021 (at the age of 52-years-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Patient historical vaccine includes received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), 1st dose via an unspecified route of administration, administered in on unspecified date as 1st DOSE, SINGLE DOSE for covid-19 immunization. The first shot no reaction whatsoever. The reaction was only the pinch. The patient medical history was not reported.  There were no concomitant medications. On an unspecified date the patient experienced chills, i woke on and off, feeling achy and feverish, also i bit my tongue, she feels her tongue acting like its weird/ its like acting weird, she feels like its numb, not flexible, ache, pinch. Therapeutic measures were taken as a result of feeling achy and feverish, feeling achy and feverish. The outcome of events was unknown.  Information about lot/batch number is requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swollen tongue
Clinical narrative: chills; I woke on and off; feeling achy and feverish; feeling achy and feverish; Also I bit my tongue; she feels her tongue acting like its weird/ Its like acting weird, she feels like its numb, not flexible; Ache; Pinch; This is a spontaneous report from a contactable consumer or other non-Health Care Professional.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), dose 2 via an unspecified route of administration, administered in Arm Right on 05Jun2021 (at the age of 52-years-old) as 2ND DOSE, SINGLE DOSE for covid-19 immunization. Patient historical vaccine includes received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiry date: Unknown), 1st dose via an unspecified route of administration, administered in on unspecified date as 1st DOSE, SINGLE DOSE for covid-19 immunization. The first shot no reaction whatsoever. The reaction was only the pinch. The patient medical history was not reported.  There were no concomitant medications. On an unspecified date the patient experienced chills, i woke on and off, feeling achy and feverish, also i bit my tongue, she feels her tongue acting like its weird/ its like acting weird, she feels like its numb, not flexible, ache, pinch. Therapeutic measures were taken as a result of feeling achy and feverish, feeling achy and feverish. The outcome of events was unknown.  Information about lot/batch number is requested.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: experienced some fatigue after the first injection; This is a spontaneous report from a contactable consumer or other non hcp (patient's mother) Pfizer sponsored program.  A 12-years-old male patient received BNT162B2, (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: was not reported) via an unspecified route of administration on an unspecified date as 1st dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced some mild fatigue after the first injection on an unspecified date. The reporter wanted to know why the Pfizer covid-19 vaccine dose was being used in kids only 10 mcg while the dose used in 1215-year-old is the same as the adult dose, 30 mcg. The outcome of the event was unknown.   No further information was provided or obtained.