chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea, Sinus disorder
Clinical narrative: has not been feeling well since receiving the pfizer covid vaccine; has an ongoing, non stop headache/her head really hurts; stuffy and runny nose; stuffy and runny nose; very tired and not herself; dizzy; seems like sinus issues going on; This is a spontaneous report from a contactable consumer (patient's mother) via Pfizer Medical Information department.    A 12-years-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot Number: FA6780) via an unspecified route of administration on 24Jul2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. On Jul2021 the patient experienced not been feeling well since receiving the pfizer covid vaccine, had an ongoing, non stop headache/her head really hurts, stuffy and runny nose, stuffy and runny nose, very tired and not herself, dizzy, seems like sinus issues going on. Therapeutic measures were taken as a result of has an ongoing, non stop headache/her head really hurts. The patient had an ongoing, non stop headache and was given Motrin. The patient also experienced stuffy and runny nose. The patient was very tired and not herself. The clinical outcome of the event seemed like sinus issues going on. Patient did not recover at the time of this report while other events outcome was Unknown.  QR Comment: Reporter type was not available over the call as the reporter denied answering further questions, hence reporter type captured as consumer or non-healthcare professional by default.   Follow-Up (05Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: Few minutes after vaccine indicated chest pain that passed/ she had chest pains on/off from day she received first dose; This is a spontaneous report from a contactable consumer, the patient.   A 13-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0181), dose 1 via an unspecified route of administration, administered in arm left on 07Jul2021 at 17:30 (age at vaccination 13-years-old)  as DOSE 1, SINGLE for covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Medical history included chest pains (chest pains documented when younger) and POTS (Postural orthostatic tachycardia syndrome) from an unknown date and unknown if ongoing. Patient had known allergies to scallops. There were no concomitant medications (List of any other medications the patient received within 2 weeks of vaccination: No). Prior to 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 4 weeks prior to the COVID vaccine. It was reported patient received first dose of Covid Vaccine on 07Jul2021, few minutes after vaccine indicated chest pain that passed, assumed preliminary reaction based on expected side effects.  Patient did not complain after that.  She went to beach with friend. Today 28Jul2021 she was scheduled to get second vaccine but she informed that she had continued chest pains when she was at the beach 2 weeks prior and that she had chest pains on/off from day she received first dose until day after returned from beach (17Jul2021).  She indicated she had not had them since. Due to this second dose was proceeded to be cancelled which was scheduled for today and possibly consider waiting a little to get second dose. Also it was asked if the second dose could get delayed. The event did not result in hospitalization. Patient did not receive any treatment for the event. The event was reported as non-serious. The clinical outcome of the event was recovered on 17Jul2021.  Information on the lot/ batch number is available. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac flutter, Electrocardiogram, Feeling abnormal, Inappropriate schedule of product administration, Palpitations
Clinical narrative: My heart was fluttering and pounding in ways it never had before. I felt it in my neck and chest.; My heart was fluttering and pounding in ways it never had before. I felt it in my neck and chest.; Very strange sensation and scary; Patient received bnt162b2 dose 1 and dose 2 on 10Jun2021 for covid-19 immunization.; This is a spontaneous report from a contactable consumer (patient). A 58-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 10Jun2021 (Batch/Lot Number: EW0175) as dose 1, single, and dose 2 via an unspecified route of administration, administered in Arm Left on 10Jun2021 (Batch/Lot Number: EW0180) as dose 2, single (both doses at the age of 58-year-old) for covid-19 immunization. Medical history included hypothyroid, cardiac flutter (It happened once when I was driving and I had to stop the car), palpitations (It happened once when I was driving, and I had to stop the car). Known allergies were reported as no. Concomitant medications included levothyroxine 75 mcg daily. Patient did not receive any other vaccine in four weeks. Patient did not have covid prior vaccination and was not tested post vaccination. The patient reported that on 03Jul2021, her heart was fluttering and pounding in ways it never had before. She felt it in her neck and chest. Very strange sensation and scary. It happened once when she was driving, and she had to stop the car. These symptoms occurred randomly day and night for about 10 days. The patient went to see her healthcare provider and had an EKG done, results were normal. Seriousness criteria: results in death, Life threatening, caused/prolonged hospitalization, disabling/Incapacitating, congenital anomaly/birth defect was reported as no. The patient underwent lab tests and procedures which included electrocardiogram: normal on an unspecified date of 2021. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for adverse event. Device date was provided as 28Jul2021. The outcome of events cardiac flutter, heart pounding and feeling abnormal was recovered on an unspecified date of 2021.   Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue ulceration
Clinical narrative: Tongue liaisons; This is a spontaneous report from a contactable consumer (patient herself). A 36-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8731, Expiry date: Unknown) via an unspecified route of administration in arm left on 04May2021 at 07:30, as dose 2, single for COVID-19 immunization. Medical history included, known allergies to Lactose intolerant and Amoxicillin. 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 previously took bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EW0153, Expiry date: Unknown) via an unspecified route of administration in arm left on 13Apr2021, as dose 1, single for COVID-19 immunization. On 04May2021 at 19:00, the patient experienced tongue liaisons. No corrective treatment was given for the event. The outcome of the event was not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm after first shot; This is a spontaneous report from a non-contactable consumer, the patient reported for himself/herself.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number was not reported/not available), via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. It was stated that, on an unspecified date, the patient experienced sore arm after first shot. The event was reported as non-serious. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, had not been tested for COVID-19. The outcome of the event was reported as recovered on an unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain of skin, Pruritus
Clinical narrative: My Head itches all the time and when I brush my hair it hurts my scalp.; My Head itches all the time and when I brush my hair it hurts my scalp.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old non-pregnant female patient received second dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EC8734, Expiry date: not reported, age at vaccination: 56-year-old), via an unspecified route of administration, administered in Arm Left on 28Mar2021 as dose 2, single for covid-19 immunisation administered in Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. Previously the patient received first dose of bnt162b2 (dose 1, Lot number ER8734, in Arm left on an unknown date at 03:15 PM) for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Did not receive any other medications within 2 weeks of vaccination. The patient was not diagnosed with covid-19 prior to vaccination and was not tested for covid-19 since the vaccination. On an unknown date in Jun2021, the patient's head itches all the time and when she brush her hair it hurts her scalp. No treatment was received for the events. The outcome of events was recovered on an unknown date.  Follow-up attempts are completed. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache; Chills; Mild fever; Muscle pain; Injection site swelling; Back pain; This is a spontaneous report from a contactable consumer (the patient).   A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection, Batch/Lot number and expiration date were not reported) via an unspecified route of administration, in the left arm, on 27Jul2021 09:30 (age at vaccination was 42-year-old), as a single dose, for COVID-19 immunization. The patient's medical history included diabetes. Patient previously received aspirin and ibuprofen and experienced drug allergy. Concomitant medications included metformin, glipizide, rosuvastatin and vitamins. The patient's historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number and Expiration date were not reported) via an unspecified route of administration in the left arm on 06Jul2021 09:30 (age at vaccination was 42-year-old) as a single dose, for COVID-19 immunization. On 27Jul2021 at 22:00, the patient experienced the headache, chills, mild fever, muscle pain, injection site swelling and back pain. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Patient was not tested for COVID-19, since the vaccination. Patient did not receive the any treatment for events. Outcome of the events was not recovered.    The lot number for the vaccine. (BNT162B2), was not provided and will be requested during follow-up.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: Headache; Chills; Mild fever; Muscle pain; Injection site swelling; Back pain; This is a spontaneous report from a contactable consumer (the patient).   A 42-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: solution for injection, Batch/Lot number and expiration date were not reported) via an unspecified route of administration, in the left arm, on 27Jul2021 09:30 (age at vaccination was 42-year-old), as a single dose, for COVID-19 immunization. The patient's medical history included diabetes. Patient previously received aspirin and ibuprofen and experienced drug allergy. Concomitant medications included metformin, glipizide, rosuvastatin and vitamins. The patient's historical vaccine included first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Batch/Lot number and Expiration date were not reported) via an unspecified route of administration in the left arm on 06Jul2021 09:30 (age at vaccination was 42-year-old) as a single dose, for COVID-19 immunization. On 27Jul2021 at 22:00, the patient experienced the headache, chills, mild fever, muscle pain, injection site swelling and back pain. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior to vaccination. Patient was not tested for COVID-19, since the vaccination. Patient did not receive the any treatment for events. Outcome of the events was not recovered.    The lot number for the vaccine. (BNT162B2), was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Pain in extremity
Clinical narrative: Sore in arm after shot/After second shot symptoms were worse; tired/After second shot symptoms were worse; headache/After second shot symptoms were worse; inappetance/After second shot symptoms were worse; This is a spontaneous report from a contactable consumer.   A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation was Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE and dose 2 via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE as for COVID-19 immunization. The Pregnancy at time of Vaccination was Unknown. The patient medical history included COVID-19 and the patient concomitant medication was not reported. On an unspecified date, the patient experienced sore in arm after the shot, next day very tired with dull headache and decreased appetite, following day more tired. After second shot symptoms were worse. Since the vaccination, the patient was not tested for COVID-19. The outcome of all events was recovered on an unspecified date.  The lot number for the vaccine, (BNT162B2), was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Illness, Pain
Clinical narrative: Low grade fever; Chills; Body aches; Joint pains; Headache; severely sick; This is a spontaneous report from a contactable consumer (patient). This 59-year-old female consumer (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA7484, Expiry Date, NDC Number: Unknown), via an unspecified route of administration, administered on left upper arm on 25Jul2021 at 15:30 (at the age of 59-year-old) as dose 1, single for covid-19 immunization. Medical history included Covid 19 which she had in the first part of October and had double pneumonia. She was sick a long time but got well. She was recommended to get the vaccine. The patient took Covid vaccine as per doctor recommendation since she had such a bad case of it, in dental field and a sister with chemo. No investigation assessment. The patient's concomitant medications were not reported. Patient stated that she got the Covid vaccine on 25Jul2021 (Sunday) and had been severely sick since then. She felt like she had Covid all over again. She wanted to know whether it was normal to have it this long or not. She wanted to know whether this was something she should be concerned with or not. She had a low grade fever, chills, body aches, joint pains, headache and severely sick on 26Jul2021. Stated that she took Advil for the chills, body aches. Stated that she had tried hot showers but it did not help. Stated that the Advil would break her fever and as soon as that went away it came back. Stated that all the events started at 12:01 am on Monday. She was about to overdose on Advil to make it tolerable to keep the fever down and for her body aches because they were so severe. She took four Advil every four hours. Stated that her fever came back and started climbing and the body aches were unbearable. Stated that it was just like when she had Covid last year. Stated that the first days were normal and she was not getting any better. Stated that her husband had the same shot the same day and he was fine. Stated that she did know if she could do the second one. Treatment received for all events. The outcome of all events were not recovered.   Follow-up attempts are completed. No further information is expected
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test
Clinical narrative: Low grade fever; Chills; Body aches; Joint pains; Headache; severely sick; This is a spontaneous report from a contactable consumer (patient). This 59-year-old female consumer (patient) reported for herself that she received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FA7484, Expiry Date, NDC Number: Unknown), via an unspecified route of administration, administered on left upper arm on 25Jul2021 at 15:30 (at the age of 59-year-old) as dose 1, single for covid-19 immunization. Medical history included Covid 19 which she had in the first part of October and had double pneumonia. She was sick a long time but got well. She was recommended to get the vaccine. The patient took Covid vaccine as per doctor recommendation since she had such a bad case of it, in dental field and a sister with chemo. No investigation assessment. The patient's concomitant medications were not reported. Patient stated that she got the Covid vaccine on 25Jul2021 (Sunday) and had been severely sick since then. She felt like she had Covid all over again. She wanted to know whether it was normal to have it this long or not. She wanted to know whether this was something she should be concerned with or not. She had a low grade fever, chills, body aches, joint pains, headache and severely sick on 26Jul2021. Stated that she took Advil for the chills, body aches. Stated that she had tried hot showers but it did not help. Stated that the Advil would break her fever and as soon as that went away it came back. Stated that all the events started at 12:01 am on Monday. She was about to overdose on Advil to make it tolerable to keep the fever down and for her body aches because they were so severe. She took four Advil every four hours. Stated that her fever came back and started climbing and the body aches were unbearable. Stated that it was just like when she had Covid last year. Stated that the first days were normal and she was not getting any better. Stated that her husband had the same shot the same day and he was fine. Stated that she did know if she could do the second one. Treatment received for all events. The outcome of all events were not recovered.   Follow-up attempts are completed. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Sleep disorder, Tinnitus
Clinical narrative: The Tinnitus became loud and persistent after the second dose; I cannot get into REM sleep because the Tinnutus is too loud and disturbing to sleep. Lack of sleep is ruining my quality of life.; This is a spontaneous report from a contactable consumer (patient). A 56-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EW0181; Expiration Date: Aug2021), via an unspecified route of administration in left arm on 30Jun2021 10:00 as dose 2, single for COVID-19 immunization. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection, Lot Number: EW0181), via an unspecified route of administration in right arm on 09Jun2021 10:00 as dose 1, single for COVID-19 immunization (at the age of 56-year-old). The patient medical history was not reported. There were no concomitant medications. The patient experienced the tinnitus became loud and persistent after the second dose and I cannot get into rem sleep because the tinnutus is too loud and disturbing to sleep. lack of sleep is ruining my quality of life (disability) on 30Jun2021. Reported Seriousness criteria was Persistent/significant disability/ incapacity. It was reported that, first dose caused strong reaction of tinnitus the night patient had the first dose. It subsided and there were no lasting side effects. Patient should have taken that as a warning. The tinnitus became loud and persistent after second dose. It was now 24/7. The biggest issue was sleeping. Patient could not get into REM sleep because the Tinnitus was too loud and disturbing to sleep. Lack of sleep was ruining his quality of life. Patient received treatment with Supplements (Rx) to sleep for the events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021861264 Same patient,  different dose,  different event (split)
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Hypoaesthesia, Neuralgia, Paraesthesia, Pruritus
Clinical narrative: shingles; I had severe nerve pain in my back and arms; numbness; tingling; itching; This is a spontaneous report from a non-contactable consumer (patient herself). A 49-year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), via an unspecified route of administration, administered in arm left on 31Mar2021 (Batch/Lot Number: ER8730) as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. Relevant medical history includes diabetes, fibromyalgia and known allergies to sulfa. The patient was not diagnosed with COVID- 19 prior to vaccination. The patient's concomitant medications were not reported. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient historically received flu vaccine for immunization on an unspecified date and experienced known allergies. On 01May2021, patient stated that she had severe nerve pain in my back and arms, numbness, tingling and itching on torso which then developed into shingles. The adverse event result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment for the adverse events was antiviral. The patient has not been tested for COVID-19 since the vaccination. Patient recovered with lasting effects on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Getting fully PHIZER vaxed helped relieve some of LC symptoms; This is a spontaneous report from a contactable consumer (patient). A 62-year-old patient unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not provided) via an unspecified route of administration, on an unknown date, as dose 1 and dose 2, single for COVID-19 immunization. Medical history included COVID-19, Hashimoto's disease, Lyme disease, and Epstein-Barr virus infection. Concomitant medications were not reported. It was reported that the patient was got fully vaccinated with Pfizer and helped in relieving some of Long term Covid symptoms. The patient felt like immune system can't fight off mutated virus. The patient was been almost in lockdown since Feb 2020. Hostile anti-maskers on occasions they must go out. The patient requested to please sign up for pfizer booster trial. The outcome of the events was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain, Vaccination site urticaria
Clinical narrative: Lots of site pain; a patch of hives distal to the site; shoulder muscles (rotator cuff) really sore; This is a spontaneous report from a contactable consumer (patient). A 21-years-old non-pregnant female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in Arm Left on 25Jul2021 (age at the time of vaccination was 21-year-old) (Lot Number: FA7484) as dose 1, single for covid-19 immunization. Medical history included loose ligaments, multiple left shoulder subluxations, intermittent malt and gluten sensitivity, intermittent malt and gluten sensitivity, patient diagnosed with COVID-19 (Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination the patient had not tested for COVID-19. Concomitant medications included List of any other medications the patient received within 2 weeks of vaccination: flaxseed oil [linum usitatissimum seed oil] (FLAXSEED OIL); vit d [vitamin d nos] (VIT D); zinc; ascorbic acid (VIT C) taken for an unspecified indication, start and stop date were not reported.On 26Jul2021 07:00, the patient experienced Lots of site pain; a patch of hives distal to the site; shoulder muscles (rotator cuff) really sore. The patient was not Hospitalized Prolonged. The patient does not receive any treatment for AEs. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. The most recent COVID-19 vaccine was administered in pharmacy or Drug Store. The outcome of events was recovering.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: she put in and I had pain in my arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: EL1283) via an unspecified route of administration on 21Jan2021 as single dose for covid-19 immunisation. The patient's medical history included weight abnormal, diabetes mellitus, fibromyalgia and autoimmune disorder. The patient's concomitant medications were not reported. The reporter states she put in and patient had pain in arm on an unspecified date. The outcome of the event was unknown.  No further information was reported.
Sex: U
Vaccine: COVID19, UNK, UNK
Symptoms: Cardiac disorder, Insomnia
Clinical narrative: I have a hard time sleeping anyway because of my heart condition; I have a hard time sleeping anyway because of my heart condition; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (BNT162B2, 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 number Unknown, Single for COVID-19 immunization; disopyramide phosphate (NORPACE CR), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication; disopyramide phosphate (NORPACE), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unspecified date patient experienced  have a hard time sleeping anyway because of my heart condition. The patient stated, I am taking Norpace and Norpace CR, for several years, at the request of my doctor. What I called about 3 days, 4 days ago is, is there any news on Norpace CR which has been discontinued and that is the drug that I take along with the regular Norpace. So what he did was send me 2 Norpace so that I can get up in the middle of the night and take a second one which would be like a continuous release. It is kind of hard because I have a hard time sleeping anyway because of my heart condition. It is highly effective. I just want to get the CR. I do love that drug. It is a life saver. That is the number on the letter but you listen for 10 minutes stories about Pfizer shots, which I have already had. Note: The patient is date of birth/ address was not provided on the phone call. The following information was not confirmed during the call, but retrieved from the system: Reporter phone No. The following information was not provided during the call: Patient gender. The outcome for both events 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
Symptoms: Eye disorder
Clinical narrative: Another young man in 30's in same community also reported eye problems after shot; This is a spontaneous report from a non-contactable consumer. A 4-decade-old (in his 30's) male patient received bnt162b2 (Formulation: solution for injection), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that 'another young man in 30's in same community also reported eye problems after shot' on an unknown date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Eye swelling, Hypersensitivity, Urticaria
Clinical narrative: hives; my eyes are swollen; I had a allergic reaction, it caused me to have hives; This is a spontaneous report from a contactable consumer (patient). A 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EW0185. Expiry Date: Unknown) via an unspecified route of administration, administered in Arm Left on 27Jul2021 (at the age of 55-years-old) as dose 1, single for COVID-19 immunization. Medical history included hypertension (Verbatim: High blood pressure) and diabetes mellitus (Verbatim: Diabetes) from an unknown date and unknown if ongoing. Concomitant medications included metformin (METFORMIN), metoprolol (METOPROLOL), amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported. Reporter stated that she went for unspecified laboratory Test 2 months ago. On Jul2021 the patient experienced hives, my eyes are swollen, i had an allergic reaction, it caused me to have hives (hypersensitivity). When paraphrased, consumer stated she called her doctor already, so she was waiting to hear from someone, but they wanted her to report it. Reporter stated she did not receive any other vaccine prior 4 weeks of vaccination. She stated she have been taking Benadryl. Therapeutic measures were taken as a result of hives, my eyes are swollen (eye swelling), i had a allergic reaction, it caused me to have hives (hypersensitivity). The outcome of the events was unknown on an unspecified date.  Follow-Up (06Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstruation normal
Clinical narrative: When I received my second shot a few days later I started a regular period again; I take my birth control very religiously and have been spotting/ been on my period for almost 3 weeks now which is incredibly unusual; This is a spontaneous report from a contactable consumer or other non hcp.    A 30-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection(Batch/Lot number was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 02Apr2021 as dose 2, single for covid-19 immunisation .Medical history included oligomenorrhoea, I take birth control continuously so I skip my periods and have not had my  period or any spotting for 6 months up , contraception take birth control continuously , migraine. Concomitant medication(s) included amphetamine aspartate, amphetamine sulphate, dexamphetamine saccharate, dexamphetamine sulphate; fluconazole, vitamin d. Patient previously took first dose of vaccination in right arm for covid 19 immunization.No other medications the patient received within 2 weeks of vaccination, the patient did not receive any other vaccine in four weeks. Prior to vaccination patient was not diagnosed with COVID. Post vaccination patient did not test for COVID.It was reported that take birth control continuously, so skip my periods and have not had my period or any spotting for 6 months up until a week after my first shot. When I received my second shot a few days later started a regular period again. And take my birth control very religiously and have been spotting/ been on my period for almost 3 weeks now which is incredibly unusual. My friend also mentioned the same thing happened to her after receiving the Pfizer vaccine so thought to reach out. On unknown date of Apr2021 the outcome of the event was not Recovered, and no treatment was received. The case has been assessed as non serious.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021384998 same reporter/product/event, different patient
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Ear congestion, Head discomfort, Headache, SARS-CoV-2 test
Clinical narrative: Headache pressure get worse; Headache; Pressure in my head; Ear congestion; This is a spontaneous report from a contactable consumer or other non-health care professional (Patient). A 72-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EK9231 and expiration date was not reported), second dose via an unspecified route of administration, administered in Arm Left on 06Jan2021 (at the age of 72 years) as single for covid-19 immunisation. Medical history included heart arteries, lactose intolerance from an unknown date and unknown if ongoing (Known allergy- Lactose intolerance). Concomitant medication(s) included ramipril (ALTACE, oral capsule, 1.25 mg), metoprolol tartrate (25 mg), amlodipine besilate (NORVASC, 2.5 MG), ranolazine (RANEXA, 500 mg), lactobacillus acidophilus (ACIDOPHILUS), colecalciferol (VITAMIN D [COLECALCIFEROL]), calcium , clopidogrel bisulfate (PLAVIX, 75 mg), acetylsalicylic acid (ASPIRIN EC, 325 mg), isosorbide mononitrate (ISOSORBIDE MN, 30 mg), famotidine (tablet, 40 mg) and Multi Vitamin taken for an unspecified indication, start and stop date were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Patient was not pregnant at the time of vaccination. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number and expiration date was not reported), first dose via an unspecified route of administration, on unspecified date as single for covid-19 immunisation. On 15Jan2021 the patient after second shot about a week and a half after she developed a headache that would not go away. Pressure in head and ear congestion. Headache pressures get worse when she bends down or look up. Also had been to ENT and she does not know what is going on and scheduled to see a neurologist in September. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. On unspecified date the patient underwent lab tests and procedures which included sars-cov-2 test found to be negative. Patient had been being treated with 5 doses of steroids and nothing seems to help. The outcome of the events was not recovered.   No follow-up attempts are possible. No further information is expected
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine
Clinical narrative: migraines everyday; This is a spontaneous report from a contactable consumer or other non-HCP (patient). A 30-years-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: UNKNOWN), via an unspecified route of administration on 18Jun2021 (age at the time of vaccination 30-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 vaccine on an unspecified date as a single dose for COVID-19 immunization. On an unspecified date, the patient experienced migraines everyday. Patient has already sought treatment via HCP. Wondering if others have reported this as well. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Lip swelling, SARS-CoV-2 test, Urticaria
Clinical narrative: Allergies have been bad starting about 3 weeks after vaccination.; lips are constantly swelling up; had issues with hives for about 6-8 weeks; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: ER8735) via an unspecified route of administration in the left arm on 15Apr2021 at 14:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. Medical history included food and milk allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, lot number: EP7534) via an unspecified route of administration in the left arm on 25Mar2021 at 13:00 (at the age of 31-year-old) as a single dose for COVID-19 immunisation. On 05May2021 at 20:00, 3 weeks after vaccination, the patient experienced allergies, that included new allergies that he never had it before and also an increase on those mild ones that he had before but never caused an issue. The patient lips were constantly swelling up and he had issues with hives for about 6-8 weeks. It had been somewhat manageable. The patient reported that he was using medications and completely changed his diet. He had never had any of these issues before the vaccine. He had heard others having the same issues. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of adverse events which included treatment with unspecified medications and diet change. Since the vaccination, the patient had been tested for COVID-19. On 07Jun2021, the patient underwent nasal swab and the result was negative for COVID-19. The clinical outcome of the events allergy, lips were constantly swelling up and hives was not resolved at the time of this report.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: fever; body ache; flu-like symptoms; This is a spontaneous report from a contactable other hcp (Nurse Practitioner). A 49-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 30Jun2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. Medical history included covid-19 from Jun2020 to an unknown date. The patient's concomitant medications were not reported. On an unknown date in 2021, the patient experienced fever, body ache, flu-like symptoms. It was reported that The Caller wants to check what to do with his patient since his patient got tested positive last Jun2020 and got the 1st dose of the vaccine last 30Jun2021. His Patient had a significant reaction like lymph nodes, fever, body ache and flu-like symptoms. His patient worries over the myocarditis and pericarditis side effects. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jun2020. The outcome for all events was unknown.   The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dyspnoea, Fatigue, Feeling hot, Headache
Clinical narrative: Friday the 23rd lost filling in left arm could not make a fist; Saturday 24th very fatigued; diarrhea; itching coming about the body; shortness of a breath; hives all over the body; hot to touch; hard to breathe; Itchy feeling and throat and tongue; Itchy feeling and throat and tongue; Also had bad headaches for 2 days; This is a spontaneous report from a contactable consumer (patient). A 48-Years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in Left arm on 23Jul2021 13:15 (age at the time of vaccination 48-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. Patient had no known allergies. On 23Jul2021 13:15, the patient experienced Friday the 23rd lost filling in left arm could not make a fist; Saturday 24th very fatigued; diarrhea; itching coming about the body; shortness of a breath; hives all over the body; hot to touch; hard to breathe; Itchy feeling and throat and tongue; and also had bad headaches for 2 days. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient received 2 types of medication to help with the hives as a treatment for adverse events. No covid prior vaccination. No covid tested post vaccination. The outcome for all the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Sensory loss, Throat irritation, Tongue pruritus, Urticaria
Clinical narrative: Friday the 23rd lost filling in left arm could not make a fist; Saturday 24th very fatigued; diarrhea; itching coming about the body; shortness of a breath; hives all over the body; hot to touch; hard to breathe; Itchy feeling and throat and tongue; Itchy feeling and throat and tongue; Also had bad headaches for 2 days; This is a spontaneous report from a contactable consumer (patient). A 48-Years-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: was not reported), via an unspecified route of administration, administrated in Left arm on 23Jul2021 13:15 (age at the time of vaccination 48-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No other vaccine in four weeks. Patient had no known allergies. On 23Jul2021 13:15, the patient experienced Friday the 23rd lost filling in left arm could not make a fist; Saturday 24th very fatigued; diarrhea; itching coming about the body; shortness of a breath; hives all over the body; hot to touch; hard to breathe; Itchy feeling and throat and tongue; and also had bad headaches for 2 days. Adverse events resulted in Doctor or other healthcare professional office/clinic visit. Patient received 2 types of medication to help with the hives as a treatment for adverse events. No covid prior vaccination. No covid tested post vaccination. The outcome for all the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Headache
Clinical narrative: headaches; Diarrhea; dizziness/when I am sleeping if I move my head I get dizzy; This is a spontaneous report from a contactable consumer. This 85-year-old female consumer (patient) reported for herself that she received bnt162b2 (BNT162B2 Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Right on 23Jul2021 (Batch/Lot Number: EW0179; Expiration Date: 30Aug2021) as DOSE 1, SINGLE for covid-19 immunisation.(85 years old at the age of vaccination). Medical history included salivary gland neoplasm from an unknown date and unknown if ongoing , ankle fracture from an unknown date and unknown if ongoing , hernia from an unknown date and unknown if ongoing. There were no concomitant medications. The patient experienced dizziness/when i am sleeping if i move my head i get dizzy on Jul2021 with , diarrhea on 23Jul2021, headaches on 26Jul2021. She states that she went home, ate dinner, and had diarrhea. The diarrhea cleared up on Friday but she started to get headaches and dizziness. She states that the headaches are all the time, morning, noon, and night. She is wondering if she is doing something wrong, and she is looking for guidance on the second vaccine as well. She states that she was leery to receive the first vaccine but has a very ill brother with cancer and she wants to visit him. So she felt like it was important to get the vaccine. She mentioned that she talked to someone from Pfizer earlier but they hung up on her and were very rude. She states she does not have an interaction number. Caller wants to know what does she take for these headaches and dizziness? She states she thought there was something wrong with her. She said  she gets headaches but she takes an aspirin, take Tylenol, an Excedrin and boom its gone, but this is constant morning, noon, night. She gets up to go to the bathroom in the middle of the night and headache. She said what's going on? She states is she taking something wrong? So all she does is take her excedrin and her aspirin and then after a little while it goes away but then later on it comes back again so. She states she will have to call her doctor. Therapeutic measures were taken as a result of headaches. The outcome of the event Diarrhea was resolved on 23Jul2021 and other events was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of consciousness, Road traffic accident
Clinical narrative: passed out in car and went into an accident; passed out in car and went into an accident; This is a spontaneous report from a contactable consumer (patient). A 36-year-old female non-pregnant patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unspecified route of administration, administered in the right arm on 21Jun2021 16:00 (batch/lot number and expiry date unknown) at 36 years of age as dose 1, single for covid-19 immunization in a doctor's office/urgent care facility. Medical history included malignant melanoma. The patient had no covid prior vaccination. There were no concomitant medications. The patient had no other medications in two weeks. The patient had no other vaccine in four weeks. The patient informed that on 21Jun2021 16:30, she passed out in car and went into an accident. The event resulted in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care visit. The patient has no covid tested post vaccination. The patient did not received treatment due to the events. The outcome of the events was recovered.  The lot number for the vaccine, bnt162b2, was not provided and will be requested during follow up.