chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Malaise, Pain, Palpitations, Sleep disorder
Clinical narrative: heart was racing and pounding and her breathing was labored; She decided to go to bed as she wasn't feeling well; but was unable to sleep well that night as she kept waking up every 2 hours; heavy breathing; got "achy"; This is a spontaneous report from a contactable consumer (patient) received from a initiative; CEP 159558. A 67-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), via an unspecified route of administration on an unspecified date as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Enquired, caller received the first Pfizer covid vaccination in the morning and that night about 8 PM experienced side effects, after first dose her heart was racing and pounding and her breathing was labored. She decided to go to bed as she wasn't feeling well but was unable to sleep well that night and got achy as she kept waking up every 2 hours. These symptoms subsided on their own, without intervention. The caller was scheduled to receive her second dose tomorrow but was worried about these side effects happening again and being more pronounced as this will be the second dose. The caller wanted to know whether the side effects would be worse in the second shot. Stated that, she heard that people have worse side effects after the second dose. The caller stated that, her physician had the Moderna COVID vaccine (she was fairly sure as this was the only one her family physician's office was offering) and couldn't sleep the night after he received it. She wanted guidance from Pfizer as to whether she should receive the second dose and when she needed to seek medical attention if the side effects occur again. Any unaddressed medical questions referred or forwarded to Medical Information was reported as yes. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot been obtained.
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Atelectasis, Costochondritis, Dyspnoea, Pneumothorax
Clinical narrative: Costal chrondritis; Atelectasis; Dyspnea; Her husband has partially collapsed lungs.; This is a spontaneous report from contactable consumer (patient) reported for himself. A 43-year-old male patient received second dose of bnt162b2 (Pfizer/BioNTech Covid-19 vaccine, Solution for injection, Lot/ Batch number: en6204), via an unspecified route in the left arm on 19Mar2021 (age at vaccination: 43-year-old) at 12:15, as a single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included first dose of bnt162b2 (Pfizer/BioNTech Covid-19 vaccine, Solution for injection, Lot/ Batch number: el9267) via an unspecified route in the left arm on 26Feb2021 at 12:15, as a single dose for covid-19 immunization. There were no reported allergies to medications, food, or other products. Patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Patient did not receive any other medications within two weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 20Mar2021 at 12:00, after getting the 2nd dose, patient experienced costal chrondritis, atelectasis and dyspnea. Adverse events resulted in doctor or other healthcare professional office/clinic visit. On an unknown date in Mar2021, patient had partially collapsed lungs. It was unknown if patient received any treatment for adverse events. The clinical outcome of partially collapsed lungs was unknown and costal chrondritis, atelectasis and dyspnea was not recovered at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy, Pain in extremity
Clinical narrative: Sore arm; Pregnant at the time of vaccination?: Yes; This is a spontaneous report from a contactable consumer (Patient). This consumer or other non hcp reported information for both mother and fetus/baby.  This is a {enter maternal or fetus/baby} report.  A 35-years-old female Pregnant patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number EN6208), via an unspecified route of administration on 22Mar2021 at 14:30 (at the age of 35-years-old) into left arm as a single dose for COVID-19 immunization. Medical history included pregnancy from an unknown date and unknown if ongoing Gestation period: 18 weeks. The patient's concomitant medications were not reported. The patient previously took morphine and experienced allergies. 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 had allergies to food, or other products. On 22Mar2021 at 14:30, The patient was Pregnant at the time of vaccination. On 22Mar2021 at 15:30, the patient experienced sore arm. The mother was 18 Weeks pregnant at the onset of the event.  The mother was due to deliver on 23Aug2021. No treatment medication was given for sore arm. The outcome of the event was recovering for sore arm and unknown for another event.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate increased
Clinical narrative: rapid heartbeat; dizziness; This is a spontaneous report from a contactable consumer or other non-health care professional (patient herself).   A 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6200) via an unspecified route of administration, administered in left arm on 19Mar2021 09:00 (at the age 35-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included ongoing Allergy to Amoxicillin from an unknown date in Jan 2015- She had not officially been diagnosed, but she was prescribed it at that time and had been taking it for several days. She broke out in a rash all over her body and had dryness or tightness in her throat. Her doctor said it sounded like she was having an allergic reaction and to stop taking it. No NDC/lot/expiry was reported for Amoxicillin. She was also breastfeeding. The patient concomitant medications were not reported. Family Medical History Relevant to AE(s) included as her mother also got the vaccine on Wednesday and she had the same reaction of rapid heart and dizziness on Wed 24 2021. The patient Prior Vaccinations within 4 weeks was reported as none and no AE(s) following prior vaccinations. No previous immunization with the Pfizer vaccine considered as suspect and no additional Vaccines administered on Same Date of the Pfizer Suspect. It was reported that Patient received her 1st dose of the Pfizer COVID19 Vaccine on 19Mar2021 and experienced a couple side effects. After vaccination on 19Mar2021, during 15 minutes observation window, she experienced rapid heart-beat and dizziness and these symptoms seemed to have faded by time the 15 minute observation window was up. AE did not cause to visit Emergency Room or Physician Office. No Investigation Assessment was reported. She was looking back on the sheet and those symptoms are listed as a severe allergic reaction according to the fact sheet that was given before getting the injection and asked to confirm if it was safe for her to get the second dose. Relevant tests were none. Seriousness was reported as No. The outcome of both events was recovered on 19Mar2021.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021336494 Same reporter/drug/event, different patient.;US-PFIZER INC-2021351470 same drug/reporter, different patient.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Hypoacusis, Palpitations
Clinical narrative: Woke up 3/27 left ear feels clogged hard to hear; Woke up 3/27 left ear feels clogged hard to hear; Woke up 3am heart racing; This is a spontaneous report from a contactable Nurse (patient). A 52-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: En6199) via unknown route of administration on 25Mar2021 01:15 PM (age at vaccination 52-year-old) as dose 2 single in left arm for COVID-19 immunization at Other. Medical history included migraine and COVID-19. Allergies to medications, food, or other products included Sulfa allergy. Patient was not pregnant at time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication received within 2 weeks of vaccination included ascorbic acid (VIT C), ergocalciferol (VIT D) and montelukast sodium (SINGULAIR). Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was reported that patient woke up 3am heart racing on 27Mar2021 03:00 AM and Woke up 3/27 left ear feels clogged hard to hear on 27Mar2021 04:30. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. It was unknown whether patient received treatment received for the adverse events. The outcome of event heart racing was recovered in 2021, while for others was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Ear pain, Head discomfort, Headache, Heart rate
Clinical narrative: racing and irregular heart rate/irregular heartbeat; dizziness; vomiting; locked jaw and internal ear pain also sensitive to touch; locked jaw and internal ear pain also sensitive to touch; locked jaw and internal ear pain also sensitive to touch; painful pressure in head (sensitive to touch)/severe pressure in her head/Feels like her head will explode; very severe headache/pain at the top of the head; wakes her up in the night; This is a spontaneous report from a non-contactable consumer or other non hcp. A 49-year-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL1283) via an unspecified route of administration in Arm Right on 05Feb2021 16:30 (age at vaccination was 49-year-old) as dose 1, single for COVID-19 immunization (at doctor's office). Patient was not pregnant at the time of vaccination. Patient didn't receive other vaccines within 4weeks prior to vaccination, patient received other medications rizatriptan within 2weeks prior to vaccination. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medications included rizatriptan (RIZATRIPTAN) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies, patient was not diagnosed with covid prior to vaccination, patient was not tested for covid to post vaccination. On 05Feb2021 16:30 the patient experienced racing and irregular heart rate/irregular heartbeat, dizziness, vomiting, locked jaw and internal ear pain also sensitive to touch, locked jaw and internal ear pain also sensitive to touch, locked jaw and internal ear pain also sensitive to touch, racing and irregular heart rate, painful pressure in head /severe pressure in her head/feels like her head will explode, very severe headache/pain at the top of the head, wakes her up in the night. Patient had physician office visits for the events. No therapeutic measures were taken for the events but labs ordered a heart monitor and used a heart monitor. The events were non-serious (not resulted in death, not life threatening, no hospitalization required or prolonged, no Disabling/Incapacitating and no Congenital anomaly/birth defect was reported). The outcome of the events heart rate irregular, dizziness, vomiting, trismus, ear pain, hyperaesthesia, heart rate increased, sensitive to touch, head discomfort, headache, middle insomnia was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate irregular, Hyperaesthesia, Middle insomnia, Trismus, Vomiting
Clinical narrative: racing and irregular heart rate/irregular heartbeat; dizziness; vomiting; locked jaw and internal ear pain also sensitive to touch; locked jaw and internal ear pain also sensitive to touch; locked jaw and internal ear pain also sensitive to touch; painful pressure in head (sensitive to touch)/severe pressure in her head/Feels like her head will explode; very severe headache/pain at the top of the head; wakes her up in the night; This is a spontaneous report from a non-contactable consumer or other non hcp. A 49-year-old non-pregnant female patient received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: EL1283) via an unspecified route of administration in Arm Right on 05Feb2021 16:30 (age at vaccination was 49-year-old) as dose 1, single for COVID-19 immunization (at doctor's office). Patient was not pregnant at the time of vaccination. Patient didn't receive other vaccines within 4weeks prior to vaccination, patient received other medications rizatriptan within 2weeks prior to vaccination. Medical history included migraine from an unknown date and unknown if ongoing. Concomitant medications included rizatriptan (RIZATRIPTAN) taken for an unspecified indication, start and stop date were not reported. Patient had no known allergies, patient was not diagnosed with covid prior to vaccination, patient was not tested for covid to post vaccination. On 05Feb2021 16:30 the patient experienced racing and irregular heart rate/irregular heartbeat, dizziness, vomiting, locked jaw and internal ear pain also sensitive to touch, locked jaw and internal ear pain also sensitive to touch, locked jaw and internal ear pain also sensitive to touch, racing and irregular heart rate, painful pressure in head /severe pressure in her head/feels like her head will explode, very severe headache/pain at the top of the head, wakes her up in the night. Patient had physician office visits for the events. No therapeutic measures were taken for the events but labs ordered a heart monitor and used a heart monitor. The events were non-serious (not resulted in death, not life threatening, no hospitalization required or prolonged, no Disabling/Incapacitating and no Congenital anomaly/birth defect was reported). The outcome of the events heart rate irregular, dizziness, vomiting, trismus, ear pain, hyperaesthesia, heart rate increased, sensitive to touch, head discomfort, headache, middle insomnia was not recovered.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Fast heart rate; This is a spontaneous report received from a contactable consumer (Patient) via Pfizer sponsored program. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 22Mar2021 as single dose for covid-19 immunisation. The patient medical history was not reported. There were no concomitant medications. On an unspecified date in Mar2021, the patient experienced fast heart rate. She got her 1st dose of the vaccine on 22Mar2021. She called about the side effects of the vaccine. She said she experienced a fast heart rate after getting the 1st dose of the vaccine. The outcome of event was unknown.   Follow-up attempts completed. No further information expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: He explained he then gets "dizzy when [he] gets up and when [he] moves too fast."/ Dizziness; This is a spontaneous report from a contactable consumer (patient). A 36-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER2613) via an unspecified route of administration on 24Mar2021(age at vaccination 35-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller stated that Pfizer vaccine that he got 24Mar, he confirms the COVID 19 vaccine. He stated that on 26Mar2021 (2 days after) he got the shot, he got dizzy whenever he gets up or sits down and Dizziness was reported as worsened. caller wanted to know if there was anything, he should do about it because it has been 8 days already. He wanted to speak with someone in medical information because he was supposed to get the other shot and he does not know what to do about that. The outcome of the event was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Heart pounding; This is a spontaneous report from a contactable consumer (patient). A 54-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: ER8732), via an unspecified route of administration in left arm on 25Mar2021 at 16:30 (at the age of 54-year-old) as dose 1, single for covid-19 immunisation in clinic. Medical history included left bundle branch block from 2017 and ongoing (She was diagnosed in either 2017 or 2018. She clarifies that she was diagnosed in 2017), acid reflux from an unknown date and unknown if ongoing, heart Condition from 2018 to an unknown date. Concomitant medications included omeprazole taken for acid reflux taking for about three and a half years and ongoing. The patient did not receive any other vaccines within four weeks prior to the vaccination. It was reported that she was called about the first dose of the Pfizer COVID vaccine. She has been tried to call this number. She has also been trying to call the place that she received the first dose of the COVID vaccine and has not gotten a return phone call. She has been on hold for forever. She received her first dose of the covid vaccine on 25Mar2021. That same night, her heart was racing for four hours, and pumping very hard. She does not know if she should get the second dose of the covid vaccine. She was supposed to get it on 15Apr2021. She was worried that her heart may do this again because it was pretty severe. She was asking if she does not get the second dose of the COVID vaccine on 15Apr2021, because she needs to wait, how was that going to effect her. She was asked does it cancel it out or will she have to start over. She does not have a primary care physician. She states she should have gone to the doctor. Her heart was racing for four hours and pumping very hard. She received the first dose of the covid vaccine about 4:30PM. Her heart started pumping about 10:00PM. Her heart started pumping really hard about 10:30PM, it was beating really hard. She guesses that it was a little after 2:00AM that her heart started to go back to normal. She was terrified if it was part of that or what it could be. "She was diagnosed with a heart condition in 2018. She only has to take a medication for acid reflux. She does not have to take anything else; she was healthy. The outcome of the event was resolved on 26Mar2021.  No follow-up attempts are possible. No further information is expected.  Follow-up (02Apr2021): This follow-up contains no new medically significant information.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Heart rate, Heart rate increased, Palpitations
Clinical narrative: fast heart rate/it has been high every day; fast heart rate/it has been high every day; heart palpitations; This is a spontaneous report from a contactable consumer other non-health professional (Patient). A female patient unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number, Expiry date: Unknown), via an unspecified route of administration on 10Mar2021 as dose 1, single for COVID-19 immunisation. The patients medical history was high blood pressure since Jan2021 and got a machine to keep track of it and noticed in Feb2021 it was up 5-6 times. Fast heartbeat since Feb2021, prior to vaccine. The concomitant medications were not reported. On unspecified date in Mar2021, patient experienced fast heart rate/it has been high every day, heart palpitations. The patient stated that she was about to go for her second shot today at 9AM and she was leaving in half an hour, that she was reading about the side effects that could happen with the Pfizer vaccine, stated she has a fast heartbeat, up to 94 to 100s, stated that she was trying to deal with it with her doctor, she has had a fast heart beat since Feb2021, prior to vaccine, she had it a few times like 5-6 times in Feb, states she got the first shot on 10Mar2021 form 15Mar2021-23Mar2021 it was high about 4 times, and since 24Mar2021 it has been high every day 86, 106, 94, today it was 88. Stated one or two times it palpitated so much that it was hard to sleep, felt like it was going to beat out of her pajamas. Patient was wondering if it was connected to the vaccine. Patient wanted to know if she should get the vaccine and needs an answer within 20 minutes. Patient declined report, states she does not have time because she has to get to the appointment for her second dose and has to level low in 20 minutes. The report was not related to a study or programme. The outcome of the events was Unknown.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: covid_test_result=Positive/flu like symptoms; covid_test_result=Positive/flu like symptoms; This is a spontaneous report from a contactable physician. A 69-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 26Jan2021 at 11:00 (at the age of 68-year-old) and the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via intramuscular route of administration in the right arm on 05Jan2021 at 11:00 (at the age of 68-year-old) as a single dose for COVID-19 immunisation. Medical history included hypothyroidism and had multiple allergies to medications. Patient did not have any other medications within two weeks of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 03Apr2021 at 10:00, the patient experienced flu like symptoms. On 06Apr2021, the patient underwent covid test (nasal swab test) and the result was positive. The event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the reported event. The clinical outcome of the events was recovering at the time of this report.  Information on lot/batch number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product BNT162B2 or comirnaty to the reported event vaccination failure and covid-19 cannot be ruled out.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Fibromyalgia, Hypertonia, Pain
Clinical narrative: Relapse of Fibromyalgia; Bad balance lasted 3 days; muscles in my legs are tense and tight; A lot of pain walking and standing; This is a spontaneous report from a contactable consumer. A 73-year-old male patient received BNT162B2 (solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 18Mar2021 10:45 (Batch/Lot Number: Er2613) as dose 2, single for covid-19 immunisation. Medical history included fibromyalgia once in 1980, once in 2000. Concomitant medication included diazepam (VALIUM); ibuprofen (MOTRIN [IBUPROFEN]); alprazolam (XANAX) taken for an unspecified indication, start and stop date were not reported. The patient previously took BNT162B2 for covid-19 immunisation on 12Feb2021 at the age of 73-year-old, neurontin and experienced Allergy, quinine sulfate and experienced Allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested for COVID-19. The patient did receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had severe Fibromyalgia conditions twice before, once in 1980, once in 2000 and now after 2nd Pfizer Vaccine. Patient have short relapses for a few days every so often, but symptoms do go away. His bad side effects had him grabbing on to walls and furniture to walk. Bad balance lasted 3 days. The muscles in his legs are tense and tight. A lot of pain walking and standing. It was going on to 3 weeks since my 2nd Vaccine and was still hurting. He was taking the only medications that have a beneficial effect on his body. The patient did not receive treatment for the adverse events. Outcome for the events was not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Herpes zoster, Muscle spasms, Pain
Clinical narrative: Contracted Shingles 2 days after vaccine in left armpit; Experienced whole body aches 1 day after vaccine; pain in back felt like a charlie horse; had back pain in between left shoulder blade and spin/ Pain in back got worse; This is a spontaneous report from a contactable consumer (patient) via Covid-19 Adverse Event Self-Reporting Solution (COVAES ). A 34-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in arm right on 19Mar2021 at 15:45 (lot number: EN6208; expiry date: unknown) as dose 1, single, for COVID-19 immunization. The patient had no relevant medical history. The patient had no allergies to medications, food, or other products.The patient was not diagnosed with COVID prior vaccination. There were no concomitant medications. The patient was not pregnant at the time of vaccination. The vaccine was administered in the hospital. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The patient did not receive other medications within two weeks of vaccination. On 20Mar2021 (1 day after vaccine), at 12:00, the patient experienced whole body aches, back pain in between left shoulder blade and spine, pain in back got worse; whole body aches subsided. Pain in back felt like a Charlie horse for 5 days.  She couldn't get out of bed; she was in extreme pain. On 21Mar2021, 2 days after vaccine, the patient contracted shingles in left armpit. Dr. stated that pain in back was connected to shingles. Patient was put on steroids and nerve blockers then pain subsided. Patient took antivirals (Valtrex) for shingles. Shingles rash subsiding. The events resulted to doctor or other healthcare professional office/clinic visit as well as Emergency room/department or urgent care. The events were considered serious, medically significant. Outcome of the event shingles was recovering, while for the other events was recovered on unspecified date in 2021. The patient has not been tested for COVID-19 since vaccination.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Suicidal ideation
Clinical narrative: thought about suicide; Severe Depression after both doses; This is a spontaneous report received from a contactable consumer, the patient. A 45-year-old [non-pregnant] adult female received COVID-19 immunization with the first dose of intramuscular BNT162B2 (solution for injection; batch/lot and expiry information not provided) as single dose in the left arm on 08Mar2021 at 08:00 (at 44-years-old); and the second dose of intramuscular BNT162B2 (solution for injection; batch/lot and expiry information not provided) as single dose in the right arm on 07Apr2021 at 10:45 (at 44-years-old). Relevant medical history included high blood pressure and penicillin allergy. Concomitant medications sans indication, posology and therapy dates included amlodipine; benazepril; and nebivolol hydrochloride (BYSTOLIC). The patient was not pregnant at the time of vaccination. The patient denied receiving any other vaccine within four weeks prior to this vaccine. The patient reported that she experienced severe depression after both doses. The patient explained that on an unspecified date in Mar2021, reported as about three days after the first dose of the vaccine, the patient experienced severe depression. The patient reported that on 07Apr2021, around eight hours after the second dose of the vaccine, the patient experienced severe depression. The patient reported that she thought about suicide as well. There was no treatment received. The outcome of the events severe depression and thought about suicide was not recovered.    The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dizziness, Migraine, Pain
Clinical narrative: Got dizzy; Pain in right arm and shoulder; Pain in right arm and shoulder; Low grade fever; Chills; Migraine; Aches; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 05Apr2021 at 12:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to tree nuts and COVID-19 from unknown dates. Concomitant medications included buspirone (MANUFACTURER UNKNOWN) and multivitamins (unspecified) for unknown indications from unknown dates and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 12:45, immediately after the vaccination, the patient got dizzy and had pain in her right arm and shoulder. That night and continuing into the following day, the patient had a low-grade fever, chills, aches and migraine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events got dizzy, pain in right arm and shoulder, low grade fever, chills, aches, migraine were resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Got dizzy; Pain in right arm and shoulder; Pain in right arm and shoulder; Low grade fever; Chills; Migraine; Aches; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0150) via an unspecified route of administration in the right arm on 05Apr2021 at 12:30 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included allergy to tree nuts and COVID-19 from unknown dates. Concomitant medications included buspirone (MANUFACTURER UNKNOWN) and multivitamins (unspecified) for unknown indications from unknown dates and unknown if ongoing. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 05Apr2021 at 12:45, immediately after the vaccination, the patient got dizzy and had pain in her right arm and shoulder. That night and continuing into the following day, the patient had a low-grade fever, chills, aches and migraine. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events got dizzy, pain in right arm and shoulder, low grade fever, chills, aches, migraine were resolving at the time of the report.  No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Inflammation, Pain in extremity, X-ray limb
Clinical narrative: Inflammation and throbbing in hands; Inflammation and throbbing in hands; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6204), via an unspecified route of administration in the left arm on 11Mar2021 at 05:15 (at the age of 60-year-old), as a single dose for COVID-19 immunisation. Medical history included thyroid disease - Hashimoto and thyroid (thyroid disorder NOS). The patient had a history of allergy to penicillin. Concomitant medications included levothyroxine sodium (LEVOXYL) from an unknown date for thyroid (thyroid disorder NOS). The patient previously received sulfur on an unknown date and experienced allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 14Mar2021, the patient experienced inflammation and throbbing in hands. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were taken as a result of events and included the process of X-ray of right hand and blood work. On an unknown date in 2021, the patient underwent lab tests and procedures which included X-ray of right hand, blood work and the results were unknown. The clinical outcome of the events inflammation and throbbing in hands was not resolved at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia, Vaccination site bruising, Vaccination site swelling
Clinical narrative: Fever in excess of 102; Body aches; Swelling at injection site; Bruising at injection site; This is a spontaneous report from a contactable consumer, the patient. A 55-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 15Mar2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. Medical history included depression and cholesterol. The patient was allergic to to mycin drugs. The patient had received unspecified concomitant medications within 2 weeks of vaccination. The patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 05Apr2021 at 14:00 (at the age of 55-years-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 16Mar2021 at 00:00, reportedly experienced fever in excess of 102 for over two days, body aches, swelling and bruising at injection site. Caused me to miss work both times I had the immunization. Therapeutic measures were not taken as a result of these events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. On 16Mar2021 at 00:00, the patient underwent body temperature and the result was 102. The clinical outcome of the event of fever was recovered on 18Mar2021, with the duration of two days. The clinical outcome of the events of body aches swelling at vaccination site and bruising at vaccination site was recovered on an unknown date in 2021.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Fatigue, Palpitations
Clinical narrative: heart palpitation; Just a little tired; This is a spontaneous report received from a contactable consumer (patient herself). An unspecified aged female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 05Apr2021 as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date in Mar2021 for COVID-19 immunization and experienced with fever, achy, allergic reaction, face swelling and hives. Lad data includes patient went to her family doctor and had an EKG, which didn't show any palpitations on an unspecified date. She received her second dose on 05Apr2021. She felt great on Monday and yesterday, just a little tired. However, last night (06Apr2021) at about 10:30 she started getting heart palpitations. She felt like her heart is dancing in her chest. She called the Health Department this morning. Stated they have heard of that as a Pfizer side effect. She stated that they heard the palpitation. She was put on a 3 day Holter monitor and the doctor never heard of this as a COVID vaccine side effect. She has not had heart issues before. Outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Chest discomfort, Feeling hot, Heart rate increased, Hyperventilation
Clinical narrative: A couple minutes after the vaccine, it felt like left side of chest felt tight; Heart rate was high; Oxygen showed that the patient was hyperventilating; Felt hot; Anxiety; This is a spontaneous report from a contactable consumer, the patient. A 51-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER 8733) via an unspecified route of administration in the left arm on 02Apr2021 at 18:00 (at the age of 51-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma, anxiety, acid reflux and allergy to sulfa. Concomitant medications included escitalopram oxalate (LEXAPRO), gliclazide (CLARITIN), ibuprofen (MANUFACTURER UNKNOWN) and omeprazole (MANUFACTURER UNKNOWN); all from unknown dates and for unknown indications. The patient previously the received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6208) via an unspecified route of administration in the left arm on 12Mar2021 at 18:00 (at the age of 51-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.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 02Apr2021 at 18:00, a couple minutes after the vaccination, the patient experienced tightness in left side of her chest, then it was like she could felt the vaccine going through her veins and then immediately after that felt like she was hypoglycemic times 1000. It was like it affected her glucose levels. The pharmacist tried to tell her it was anxiety. The patient knew that it was 100% not anxiety. The paramedics came and also said it was anxiety and they stated oxygen showed that the patient was hyperventilating. The patient felt like her heart rate was high and she was hot and again felt hypoglycemic. But it was not the hypoglycemia that she had felt before, she did not feel like she needed to eat to take it away. They told her since the patient was not wheezing or had any sort of rash that she could leave. The patient actually sat in the car for a half hour and therapeutic measures were taken as a result of anxiety which included treatment with ATIVAN 0.5 (unspecified units) just in case and to help herself calm down. If this was anxiety, the ATIVAN would have completely taken away the symptoms. But it did not and the patient still felt "off" two hours later. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. The clinical outcome of the events a couple minutes after the vaccine, it felt like left side of chest felt tight, heart rate was high, oxygen showed that the patient was hyperventilating, felt hot and anxiety were resolving at the time of this report.  No follow-up attempts are needed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pain in extremity
Clinical narrative: extremely severe fatigue; feeling terrible; arm pain; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration, administered in arm right on 23Mar2021 09:30 (at the age of 31 years) (Batch/Lot Number: ER2613) as a single dose for COVID-19 immunization. Medical history included blood thyroid stimulating hormone high, NSAID allergies, and Hashimoto's. Patient was not pregnant at the time of vaccination. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Patient has not been tested for COVID-19 since the vaccination. Concomitant medications (other medications in two weeks) included levothyroxine sodium (SYNTHROID) and liothyronine sodium (CYTOMEL). On 24Mar2021, the next morning, the patient could not get out of bed. She had extremely severe fatigue and missed class that whole week. The fatigue has not gone away or gotten much better and she was very concerned about getting dose 2. This is concerning because she was feeling fine and had tons of energy before the vaccine. The patient that this caused an autoimmune response as she felt like she did when her TSH was high years ago. The patient stated that it was not normal to be in bed for weeks feeling terrible after a vaccine. She went to a clinic to get an IV with vitamins on Friday, 26Mar2021 (cocktail and zinc) and felt mildly better but still not close to being better. Patient also had the normal arm pain but that resolved in 48 hours. Treatment received included: IV vitamins and saline. Outcome of the event arm pain was recovered on 26Mar2021 and of the other events was not recovered.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pain in extremity, Retching, Vomiting
Clinical narrative: aggressively heave; full body sweating; Intense nausea; pain and soreness in the arm that received the vaccination; Incapacitated with violent vomiting continued to aggressively heave and would vomit yellow bile; This is a spontaneous report from a contactable consumer, the patient. A 29-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7533) via an unspecified route of administration in the arm left on 06Apr2021 at 16:00 (at the age of 29-year-old) as a single dose for COVID-19 immunisation. Medical history included anxiety, depression on unknown dates. The patient was allergic to avocado (fruit allergy) and cinnamon (spice allergy). Concomitant medications included paracetamol (ACETAMINOPHEN), bupropion (BUPROPION XL), ethinylestradiol, norgestrel (CRYSELLE) and chlorcyclizine hydrochloride, pseudoephedrine hydrochloride (STAHIST AD) all taken from unknown date for unknown indication. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 07Apr2021 at 13:00 the patient experienced intense nausea to the point of being incapacitated with violent vomiting, after vomiting everything in the stomach, the patient continued to aggressively heave and vomited yellow bile, movement of any sort would trigger intense nausea and eventually vomiting, any solid, bland food was unable to stay down for longer than 5 minutes, vomiting was coupled with full body sweating despite having no fever and other negative effects included pain and soreness in the arm that received the vaccination. Severe symptoms lasted at least 12 hours, and less severe nausea continues. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. No therapeutic measures were taken as a result of the events. The clinical outcome of the events Intense nausea (nausea) to the point of being incapacitated with violent vomiting (vomiting). After vomiting everything in her stomach, she continued to aggressively heave (retching) and would vomit yellow bile (vomiting). Vomiting was coupled with full body sweating(hyperhidrosis) despite having no fever. Severe symptoms lasted at least 12 hours, and less severe nausea continues. Other negative effects included pain and soreness in the arm (pain in extremity) that received the vaccination were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Unevaluable event
Clinical narrative: spread of disease; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date (at the age of 60-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. Concomitant medications were not reported. The patient did not have allergies to medications, food, or other products. The patient did not receive any other medications within 2 weeks of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On an unknown date, the patient had experienced spread of disease. The adverse event did not result in doctor or other healthcare professional office/clinic visit/ emergency visit. The patient did not receive any treatment for the event. The clinical outcome of the event spread of disease was unknown at the time of this report.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.