chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: exposure during pregnancy; had breast pain; painful swollen lymph node in my left armpit / breast area.; Flu like chills; fever fluctuated from 99-101.5 F; my body felt like it was hit by a truck; This is a spontaneous report from a contactable consumer, the patient. A 32-year-old pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727), via an unspecified route of administration in the left arm on 21Mar2021 (at the age of 32-years-old) as single dose for COVID-19 immunisation. Medical history included thalassemia minor. The patient did not have any allergies to medications, food, or other products. The patient's last menstrual date was on 18Dec2020. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included pyridoxine hydrochloride; doxylamine succinate (DICLEGIS) and glucomannan (GARDEN OF LIFE PRENATAL), for unknown indications from unknown dates. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN0202), via an unspecified route of administration in the left arm on 28Feb2021 at 14:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was pregnant during vaccination with gestational period of 13 weeks. On 22Mar2021 at 02:30, 12 hours after the second dose she had flu like chills, her body felt like it was hit by a truck and she had a fever that fluctuated from 99-101.5 F. These symptoms lasted from 02:30 on 22Mar2021 until 10:00 on 24Mar2021, when she woke up and the fever broke. On 24Mar2021, in the morning, she had breast pain and noticed a painful swollen lymph node in her left armpit/breast area. The expected delivery date was on 24Sep2021. The adverse events did not result in a visit to the doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The patient did not receive any treatment for the events chills, general body pain, breast pain, fluctuating fever and painful lymphadenopathy. The clinical outcome of the events chills and general body pain were recovered on 24Mar2021 at 10:00 while that of breast pain, fluctuating fever, painful lymphadenopathy and maternal exposure during pregnancy, first trimester was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Heart rate increased, Pain
Clinical narrative: rapid heartbeat; my heart like aches and sometimes there is shooting pain; my heart like aches and sometimes there is shooting pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, batch/lot number: not reported, expiration date: unknown) via an unspecified route of administration 12Mar2021 as dose number unknown, single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Mar2021, 2 hours after vaccination, the patient started having like a really rapid heartbeat and then the patient went home and still had a rapid heartbeat and ever since then there was something like the patient's heart like aches and sometimes there was shooting pain and the patient still have a rapid heartbeat currently. So, the patient just wanted to report that in case Pfizer had any side effects reported like that or what to do from here." The patient had provided limited information over the call. The outcome of the event rapid heartbeat was not recovered, and the outcome of other events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased, Somnolence
Clinical narrative: fast heartbeat; tiredness; drowsiness; This is a spontaneous report from a non-contactable other hcp (patient). A 41-year-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Formulation:Solution for injection, Batch/Lot Number: EL3247), dose 1 via an unspecified route of administration, administered in Arm Left on 10Mar2021 13:30 (at the age of 41-years-old) as Dose 1, Single for covid-19 immunization. Medical history included seasonal allergy, dust allergy from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient experienced fast heartbeat for a few minutes tiredness drowsiness on 10Mar2021 (at 19:00). The patient underwent lab tests and procedures which included heart rate: fast.No treatment received for the events.The outcome of events was recovered on an unspecified date in 2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood
Clinical narrative: right now she feels depressed; This is a spontaneous report from a Pfizer-sponsored program. A contactable 92-year-old female consumer reported for herself.  A 92-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 19Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history includes Depression and concomitant medications include clonazepam 0.5 mg from an unspecified date and ongoing. On 20Mar2021, 1 day after the vaccination, the patient experienced depressed mood. The caller wanted to know weather she can administer clonazepam. The outcome of the event was unknown.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Heart rate, Hypotension, Palpitations
Clinical narrative: Racing heartbeat; Low blood pressure; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 18Mar2021 as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH mRNA COVID-19 VACCINE, solution for injection; Batch/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. The patient had 2nd dose of a vaccine yesterday (18Mar2021) experienced a racing heartbeat today (19Mar2021) and low blood pressure and wanted to know what to do next. The patient underwent lab tests and procedures which included blood pressure which showed low and heart rate which showed racing heartbeats on 19Mar2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased
Clinical narrative: rapid heartbeat; dizziness; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported similar events for 2 patients. This is the 2nd of the 2 reports. This consumer (patient's daughter) reported for a female patient that:  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: unknown), via an unspecified route of administration, administered on 24Mar2021 as single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported.  The patient experienced rapid heartbeat, dizziness on 24Mar2021. Her mother also received the 1st dose of the Pfizer vaccine on Wednesday and experienced the same side effects as her and she was wondering if genetics could have played a part. The patient underwent lab tests and procedures which included heart rate: rapid. The outcome of events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021335221 Same reporter/drug/event, different patient.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Heart rate increased
Clinical narrative: Fast heart beat; shortness in breath; Fatigue; This is a spontaneous report from a contactable consumer or other non hcp(patient).   A 45-years-old female patient received bnt162b2 (Pfizer covid 19 vaccine, formulation: solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administered in Arm Left on 15Mar2021 14:00 (at the age of 45-years-ol) as DOSE 1, SINGLE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to the vaccination the patient was not diagnosed with covid19. Since the vaccination the patient had not been tested for covid 19. On 25Mar2021 08:00, the patient experienced fast heart beat, shortness in breath, fatigue. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling hot, Limb mass, Pain, Pain in extremity
Clinical narrative: arm swelling; aches; so tired; that evening her heart was racing for awhile and then stopped and was normal and the next day in the early morning it was racing again and then went back to normal; arm was hurting; arm felt hot and had a lump; arm felt hot and had a lump; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6206) via an unspecified route of administration in right arm on 10Mar2021 at 11:45 (at the age of 63-years-old) as single dose for COVID-19 immunization. Relevant medical history of the patient included arthritis and fibromyalgia. Concomitant medications included supplements (unspecified). Patient did not receive any prior Vaccinations (within 4 weeks). On 10Mar2021, patient experienced that in the evening her heart was racing for a while and then stopped and was normal and the next day in the early morning it was racing again and then went back to normal, arm was hurting, arm felt hot and had a lump. On 11Mar2021, patient experienced aches, was so tired, had arm swelling. Pain and aches she didn't mind those, but when her heart started racing, she did. Patient clarified that her arm was hurting within 10-15 minutes and it felt hot and had a lump within the hour, in the arm she got the vaccine in. She was out for shopping and decided to go home. Aches started the next day and she was so tired that next day in the afternoon 11Mar2021. It lasted until Saturday and she was fine on Sunday 14Mar2021, she was herself again, all the symptoms were gone. Events did not result in visit to Emergency Room or Physician office, but patient mentioned that if the heart racing continued, she would have to visit. Patient asked if it was ok for her to get the second shot. Patient got a reminder for next week for her 2nd shot and she was not sure if she should get it. Outcome of the event heart racing was resolved on 11Mar2021, arm was hurting, arm swelling, arm felt hot and had a lump, aches, so tired were resolved on 14Mar2021.  No follow up attempts are possible. No further information is expected
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Peripheral swelling
Clinical narrative: arm swelling; aches; so tired; that evening her heart was racing for awhile and then stopped and was normal and the next day in the early morning it was racing again and then went back to normal; arm was hurting; arm felt hot and had a lump; arm felt hot and had a lump; This is a spontaneous report from a contactable consumer (patient). A 63-year-old female patient received first dose of BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: EN6206) via an unspecified route of administration in right arm on 10Mar2021 at 11:45 (at the age of 63-years-old) as single dose for COVID-19 immunization. Relevant medical history of the patient included arthritis and fibromyalgia. Concomitant medications included supplements (unspecified). Patient did not receive any prior Vaccinations (within 4 weeks). On 10Mar2021, patient experienced that in the evening her heart was racing for a while and then stopped and was normal and the next day in the early morning it was racing again and then went back to normal, arm was hurting, arm felt hot and had a lump. On 11Mar2021, patient experienced aches, was so tired, had arm swelling. Pain and aches she didn't mind those, but when her heart started racing, she did. Patient clarified that her arm was hurting within 10-15 minutes and it felt hot and had a lump within the hour, in the arm she got the vaccine in. She was out for shopping and decided to go home. Aches started the next day and she was so tired that next day in the afternoon 11Mar2021. It lasted until Saturday and she was fine on Sunday 14Mar2021, she was herself again, all the symptoms were gone. Events did not result in visit to Emergency Room or Physician office, but patient mentioned that if the heart racing continued, she would have to visit. Patient asked if it was ok for her to get the second shot. Patient got a reminder for next week for her 2nd shot and she was not sure if she should get it. Outcome of the event heart racing was resolved on 11Mar2021, arm was hurting, arm swelling, arm felt hot and had a lump, aches, so tired were resolved on 14Mar2021.  No follow up attempts are possible. No further information is expected
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Malaise, Rash
Clinical narrative: did not feel good; she saw a body rash this morning. However, when attempted to confirm event she confirmed as body rush.; had a very high heartbeat, heartrate, then everything was gone; This is a spontaneous report from a contactable consumer or other non hcp. A 54-years-old female patient received bnt162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: ER8730, Expiration date: Jul2021) via an unspecified route of administration, in right arm on 29Mar2021 at 09:00 as first dose, single for COVID-19 immunization (Age at vaccination 54 years). Medical history and family medical history relevant to AE were reported as none. No prior vaccinations (within 4 weeks) were reported. No additional vaccines were administered on same date of the Pfizer suspect. There were no concomitant medications reported. On an unspecified date, the patient just did not feel good. On 29Mar2021, patient reported that she had 2 reactions, when the vaccine was done, for next 10 minutes she had a very high heartbeat, heartrate, then everything was gone. On 30Mar2021, when patient woke up, she saw a body rash this morning however, when attempted to confirm event she confirmed as body rush. It was reported that high heartbeat started probably sometime between 9:00-9:10 AM and it occurred like ten minutes after getting the vaccine. The patient underwent lab tests which included heart rate: very high on 29Mar2021, heart rate increased: very high on 29Mar2021. Events did not require visit to Emergency room or physician Office visit. She remarked that at least at the time of reporting, she did not have to go to an EM or physicians office. Stated right now, she just did not feel good. Patient wanted to report a reaction after the vaccine and wanted to know if it would be ok to get the second dose and if it was possible to have worse reaction if you have little reaction. She has heard that the second dose can have a worse effect that the first because body has it, she was just wondering. The outcome of event heart rate increased was recovered on an unspecified date in 2021, outcome for events rash was not recovered while the event patient just did not feel good was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bone pain, Spinal X-ray
Clinical narrative: it felt like her bones got beaten with a stick; different parts of her back were hurting; 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, Lot number, expiry date, NDC number were not reported) via an unspecified route of administration on 09Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history included osteoarthritis and compression fracture. Patient concomitant medications were not reported. The patient reported 09Feb2021; that night it felt like her bones got beaten with a stick. She said the next day she did not feel so bad. She said about a week after that (on an unspecified date in Feb2021), different parts of her back were hurting. She said she received her second COVID-19 Vaccine dose on 04Mar2021. She said 2 weeks before she received her second COVID-19 Vaccine, she was hurting real bad, she said she told the lady who was giving her the second COVID-19 Vaccine what had happened to her after the first COVID-19 Vaccine, She said the lady told her she had a reaction (unspecified) from the first COVID-19 Vaccine shot, she said after her second COVID-19 Vaccine shot, things went downhill from there, she said she had osteoarthritis her pain got so bad she went to her doctor, she told her doctor she thought she had a compression fracture, she had x-rays of her back (on an unspecified date), and her doctor told her she had degenerative joint disease, which was osteoarthritis. She said she can only take Tylenol, and she had been to a massage therapist, and had used ice packs, but was still in pain, she knew who had the COVID-19 Vaccine said they did not have any problems with pain after they got the vaccine. The patient took treatment for the events. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: I got my first shot I did have a very  fast heartbeat like my heart rate was racing for about 3 hours; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported.  It was reported that on an unspecified date, the patient got first shot and did have a very fast heartbeat like patient heart rate was racing for about 3 hours. Patient was coming up for second shot, so it said to report any side effect that patient had but also had another question, shot was scheduled for the first for this Thursday (unspecified date) and patient who said cannot make appointment or reschedule it anywhere and asked how to reschedule second shot and should does need to get the second shot. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Malaise, Palpitations, SARS-CoV-2 test
Clinical narrative: heart palpitations faster than normal; right now he is notfeeling that bad compared to a couple of days after the vaccine; heart palpitation; This is a spontaneous report from a contactable consumer (patient).   A 50-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER2613), via an unspecified route of administration, administered in Arm Left on 26Mar2021 14:45 as dose 1, single for covid-19 immunisation. The patient medical history was none. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient experienced heart palpitations faster than normal, right now he is not feeling that bad compared to a couple of days after the vaccine, and heart palpitation on an unknown date. Caller stated he has the heart question after he got the Pfizer Vaccine but and right now he is not feeling that bad compared to a couple of days after the vaccine and as the day goes it is better and better and did not have to go to the hospital and nothing was needed, stated what is going on he is healthy overall and not taking any kind of medication, is 52 years old and has a healthy lifestyle, stated for 3 days he had that happen with his heart bumping but not much of an issue and he is feeling better. Stated he looked up online the reaction he had which was heart palpitation being faster than normal and looked it up on the Pfizer website about this concern and he had no other symptoms and the heart palpitations and asks if that is normal. The patient underwent lab tests and procedures, which includes Nasal swab, SARS CoV 2 Test: Negative on 31Mar2021. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitations faster than normal; right now he is notfeeling that bad compared to a couple of days after the vaccine; heart palpitation; This is a spontaneous report from a contactable consumer (patient).   A 50-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: ER2613), via an unspecified route of administration, administered in Arm Left on 26Mar2021 14:45 as dose 1, single for covid-19 immunisation. The patient medical history was none. The patient concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient experienced heart palpitations faster than normal, right now he is not feeling that bad compared to a couple of days after the vaccine, and heart palpitation on an unknown date. Caller stated he has the heart question after he got the Pfizer Vaccine but and right now he is not feeling that bad compared to a couple of days after the vaccine and as the day goes it is better and better and did not have to go to the hospital and nothing was needed, stated what is going on he is healthy overall and not taking any kind of medication, is 52 years old and has a healthy lifestyle, stated for 3 days he had that happen with his heart bumping but not much of an issue and he is feeling better. Stated he looked up online the reaction he had which was heart palpitation being faster than normal and looked it up on the Pfizer website about this concern and he had no other symptoms and the heart palpitations and asks if that is normal. The patient underwent lab tests and procedures, which includes Nasal swab, SARS CoV 2 Test: Negative on 31Mar2021. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Heart rate increased, Malaise, Palpitations, SARS-CoV-2 test
Clinical narrative: heart palpitations after first dose; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 26Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the first 3 days after the vaccine was very hard, heart was pumping faster even while patient was sleeping, no other symptoms, patient didn't go to the hospital after that. During reporting patient was not feeling bad, but first 3-4 days were not very good, patient was a health person. Patient was not on any other medications. Wanted to know if patient get the 2nd dose. On an unspecified date, the patient experienced heart palpitations after first dose. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Palpitations
Clinical narrative: heart palpitations after first dose; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 52-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number was not reported), via an unspecified route of administration on 26Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that the first 3 days after the vaccine was very hard, heart was pumping faster even while patient was sleeping, no other symptoms, patient didn't go to the hospital after that. During reporting patient was not feeling bad, but first 3-4 days were not very good, patient was a health person. Patient was not on any other medications. Wanted to know if patient get the 2nd dose. On an unspecified date, the patient experienced heart palpitations after first dose. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed mood, Emotional disorder
Clinical narrative: General sadness; She just feels really emotional; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer reported for herself that who received first dose of BNT162B2 (BNT162B2, solution for injection) via an unspecified route of administration, administered in Arm Left on 29Mar2021 (Batch/Lot Number: ER2613; Expiration Date: 30Jul2021) (at the age of 56-year-old) as SINGLE for covid-19 immunization. Medical history included breast cancer survivor from an unknown date and unknown if ongoing. Concomitant medication included ibuprofen (ADVIL [IBUPROFEN]), cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) One tablet once a day and triamcinolone acetonide (NASACORT) Once a day in nose taken for an unspecified indication, start and stop date were not reported. On 31Mar2021, the caller was having what she thinks was a side effect from the vaccine but she was not sure, she did not see it listed on the paperwork. Its odd but the side effect was general sadness. The caller wants to know if this can be from the vaccine. The caller was not a sad person, she just feels really emotional (In Mar2021). The outcome events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Tinnitus
Clinical narrative: Hear heart beating in ears. constant beating, hissing, at times ringing. never lets up; Hear heart beating in ears. constant beating, hissing, at times ringing. never lets up; This is a spontaneous report received from a contactable consumer (patient) reported for herself. A 66-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP7533, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 25Mar2021 at 11:30 am (age at vaccination was 66 years) as dose 1, single for COVID-19 immunization. The patient did not have any medical history. The patient did not have any known allergies or allergies to medications, food, or other products. Concomitant medications the patient received in two weeks included levothyroxine sodium (SYNTHROID), acetylsalicylic acid (BABY ASPIRIN) and Zanax all taken for an unspecified indication. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 26Mar2021 at 04:00 am, the patient heard heart beating in ears. Constant beating, hissing, at times ringing. Never lets up. It was so unbearable. The adverse events resulted in Doctor or other healthcare professional office/clinic visit. No treatment was received for the adverse events. The outcome of the events was not resolved.  No follow-up attempts are needed. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dyskinesia, Headache, Nausea
Clinical narrative: Generalized neuropathic and nociceptive pain; Generalized neuropathic and nociceptive pain/generalized soreness; nausea; heart racing; palpitations; tachycardia; thirst; low-grade fever; weakness; heart pounding; pounding headache; loss of appetite; excessive drowsiness (being in and out of sleep in a somewhat unusual way) while lying down; sensitivity to light; weakness made it nearly impossible for me to move; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8733), dose 2 via an unspecified route of administration, administered in Arm Right on 01Apr2021 16:30 (at the age of 40-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history medications were not reported. The patient stated other medications in two weeks: Prenatal multivitamin. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6199), via an unspecified route of administration in Right arm on 10Mar2021 16:15 as single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01Apr2021 23:30 the patient experienced generalized neuropathic and nociceptive pain, nausea, heart racing, palpitations, tachycardia, thirst, low-grade fever, weakness, heart pounding, pounding headache, loss of appetite, excessive drowsiness, sensitivity to light and weakness made it nearly impossible for me to move. No therapeutic measure was taken. The outcome of events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Neuralgia, Pain, Palpitations, Photophobia, Pyrexia
Clinical narrative: Generalized neuropathic and nociceptive pain; Generalized neuropathic and nociceptive pain/generalized soreness; nausea; heart racing; palpitations; tachycardia; thirst; low-grade fever; weakness; heart pounding; pounding headache; loss of appetite; excessive drowsiness (being in and out of sleep in a somewhat unusual way) while lying down; sensitivity to light; weakness made it nearly impossible for me to move; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8733), dose 2 via an unspecified route of administration, administered in Arm Right on 01Apr2021 16:30 (at the age of 40-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history medications were not reported. The patient stated other medications in two weeks: Prenatal multivitamin. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6199), via an unspecified route of administration in Right arm on 10Mar2021 16:15 as single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01Apr2021 23:30 the patient experienced generalized neuropathic and nociceptive pain, nausea, heart racing, palpitations, tachycardia, thirst, low-grade fever, weakness, heart pounding, pounding headache, loss of appetite, excessive drowsiness, sensitivity to light and weakness made it nearly impossible for me to move. No therapeutic measure was taken. The outcome of events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Somnolence, Tachycardia, Thirst
Clinical narrative: Generalized neuropathic and nociceptive pain; Generalized neuropathic and nociceptive pain/generalized soreness; nausea; heart racing; palpitations; tachycardia; thirst; low-grade fever; weakness; heart pounding; pounding headache; loss of appetite; excessive drowsiness (being in and out of sleep in a somewhat unusual way) while lying down; sensitivity to light; weakness made it nearly impossible for me to move; This is a spontaneous report from a contactable consumer (patient). A 40-years-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8733), dose 2 via an unspecified route of administration, administered in Arm Right on 01Apr2021 16:30 (at the age of 40-years-old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history medications were not reported. The patient stated other medications in two weeks: Prenatal multivitamin. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EN6199), via an unspecified route of administration in Right arm on 10Mar2021 16:15 as single dose for COVID-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01Apr2021 23:30 the patient experienced generalized neuropathic and nociceptive pain, nausea, heart racing, palpitations, tachycardia, thirst, low-grade fever, weakness, heart pounding, pounding headache, loss of appetite, excessive drowsiness, sensitivity to light and weakness made it nearly impossible for me to move. No therapeutic measure was taken. The outcome of events was recovering.   No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Dizziness, Fatigue, Headache
Clinical narrative: Fast heartbeat 95-126; Dizziness; weakness; Body shaking all over; Tightness across chest shoulder to shoulder; Tightness across chest shoulder to shoulder; Headache; injection site pain (could not lift my arm for 24 hrs); Tiredness; This is a spontaneous report from a contactable other health care professional (patient).   A 51-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, in Left arm on 27Mar2021 10:30 (at the age of 51-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was none (No underlying medical conditions, was in good health). Concomitant medications were not reported. The patient previously took amoxicillin, augmentin [amoxicillin;clavulanate potassium] and zyban and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced fast heartbeat 95-126, dizziness, weakness, body shaking all over, tightness across chest shoulder to shoulder, headache, injection site pain, tiredness on 27Mar2021 11:30. The patient stated, could not lift my arm for 24 hrs. The patient underwent lab tests and procedures which included heart rate resulted 95-126, on an unknown date. Therapeutic measures were taken as a result of events, the patient was referred to cardiologist. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Joint stiffness, Tremor, Vaccination site pain
Clinical narrative: Fast heartbeat 95-126; Dizziness; weakness; Body shaking all over; Tightness across chest shoulder to shoulder; Tightness across chest shoulder to shoulder; Headache; injection site pain (could not lift my arm for 24 hrs); Tiredness; This is a spontaneous report from a contactable other health care professional (patient).   A 51-years-old (non-pregnant) female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration, in Left arm on 27Mar2021 10:30 (at the age of 51-year-old) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was none (No underlying medical conditions, was in good health). Concomitant medications were not reported. The patient previously took amoxicillin, augmentin [amoxicillin;clavulanate potassium] and zyban and experienced drug hypersensitivity. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not tested for COVID-19. The patient experienced fast heartbeat 95-126, dizziness, weakness, body shaking all over, tightness across chest shoulder to shoulder, headache, injection site pain, tiredness on 27Mar2021 11:30. The patient stated, could not lift my arm for 24 hrs. The patient underwent lab tests and procedures which included heart rate resulted 95-126, on an unknown date. Therapeutic measures were taken as a result of events, the patient was referred to cardiologist. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Supraventricular extrasystoles, Ventricular extrasystoles
Clinical narrative: Heart palpitations; PVC and PAC and was symptom free but they seemed to restart after my second vaccine; PVC and PAC and was symptom free but they seemed to restart after my second vaccine; This is a spontaneous report from a contactable consumer (patient herself). A 54-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in left arm on 23Mar2021 10:00 (age at vaccination: 54 years) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medication(s) included trazodone 50mg. The patient's historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL3247) via an unspecified route of administration, administered in left arm on 01Mar2021 09:15 as DOSE 1, SINGLE for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 23Mar2021, the patient experienced heart palpitations, pvc and pac and was symptom free but they seemed to restart after my second vaccine. The events led the patient to visit Doctor or other healthcare professional office/clinic. It was unknown if any treatment was received for the adverse event. The patient was not diagnosed with covid-19 prior to vaccination nor was tested for covid-19 since the vaccination. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine, Palpitations
Clinical narrative: Intermittent rapid heart rate; Severe migraine; Headache; This is a spontaneous report from a contactable consumer, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6201) via an unspecified route of administration in the left arm on 05Mar2021 at 07:30 (at the age of 59-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, allergies and penicillin allergy. Concomitant medications included dexlansoprazole (DEXILANT). The patient previously took clarithromycin, erythromycin (reported as arythromicin), acetaminophen (TYLENOL) and all for unknown indication on an unknown date and experienced drug allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 05Mar2021 at 19:00, in the evening after receiving the first dose the patient experienced intermittent rapid heart rate which lasted several days, headache for 2 days and severe migraine lasted for a day. The events resulted in doctor or other healthcare professional office or clinic visit. The patient did not receive any treatment for the reported events. The clinical outcome of the events was recovered on an unknown date in Mar2021.   No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Flat affect, Freezing phenomenon, Headache, Pain
Clinical narrative: 18 Hours after dose, came on super fast, achy; shaking; freezing; Slept for a couple hours; headache; flattened; Eyes hurt; Guzzling water; This is a spontaneous report from a contactable consumer. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: ER-8732), via an unspecified route of administration, administration at Arm Left on 06Apr2021 (vaccinated at the age of 51 years) as dose 2, single for covid-19 immunization. Medical history and concomitant medications were not reported. The previously received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administrated on left arm on 18Mar2021 as dose 1, single for covid-19 immunization. The patient did not received other vaccine in four weeks and not received other medications in two weeks. The patient not had covid prior to vaccination and had not tested for covid post vaccination. On 07Apr2021, 18 Hours after dose, came on super-fast, achy. Then started shaking and was freezing. Slept for a couple hours and still flattened and headache. Eyes hurt and guzzling water. The patient did not receive any medication for the events. The patient was recovering from all the events.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Somnolence, Thirst, Tremor
Clinical narrative: 18 Hours after dose, came on super fast, achy; shaking; freezing; Slept for a couple hours; headache; flattened; Eyes hurt; Guzzling water; This is a spontaneous report from a contactable consumer. A 51-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Batch/Lot Number: ER-8732), via an unspecified route of administration, administration at Arm Left on 06Apr2021 (vaccinated at the age of 51 years) as dose 2, single for covid-19 immunization. Medical history and concomitant medications were not reported. The previously received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EN6208), via an unspecified route of administration, administrated on left arm on 18Mar2021 as dose 1, single for covid-19 immunization. The patient did not received other vaccine in four weeks and not received other medications in two weeks. The patient not had covid prior to vaccination and had not tested for covid post vaccination. On 07Apr2021, 18 Hours after dose, came on super-fast, achy. Then started shaking and was freezing. Slept for a couple hours and still flattened and headache. Eyes hurt and guzzling water. The patient did not receive any medication for the events. The patient was recovering from all the events.  No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dizziness, Headache, Hypertension, Tachycardia
Clinical narrative: dizziness; anxiety; hypertensive; trembling hands; a mild headache; tachycardic; This is a spontaneous report from a contactable Pharmacist. A 46-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot Number: EN6206), dose 1 intramuscular, administered in Arm Left on 15Mar2021 as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included none. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. There were no known allergies to patient. It was unknown if patient was pregnant. The patient experienced dizziness, anxiety, trembling hands, and a mild headache. Patient was hypertensive, tachycardic, and afebrile on 15Mar2021. The patient took no other vaccine in four weeks, Patient received tylennol medications in two weeks. The patient received no treatment in response to events. The patient had no covid prior to vaccination, no covid test was performed after vaccination. The clinical outcome of all events was recovered on unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: dizziness; anxiety; hypertensive; trembling hands; a mild headache; tachycardic; This is a spontaneous report from a contactable Pharmacist. A 46-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Lot Number: EN6206), dose 1 intramuscular, administered in Arm Left on 15Mar2021 as DOSE 1, SINGLE for covid-19 immunisation.  Medical history included none. Concomitant medications included paracetamol (TYLENOL) taken for an unspecified indication, start and stop date were not reported. There were no known allergies to patient. It was unknown if patient was pregnant. The patient experienced dizziness, anxiety, trembling hands, and a mild headache. Patient was hypertensive, tachycardic, and afebrile on 15Mar2021. The patient took no other vaccine in four weeks, Patient received tylennol medications in two weeks. The patient received no treatment in response to events. The patient had no covid prior to vaccination, no covid test was performed after vaccination. The clinical outcome of all events was recovered on unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.