chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Severe muscle fatigue in arms and legs; numbness and tingling started in feet and hands; tingling started in feet and hands, tingling in thighs; vibration in chest replaced by pain in same spot; painful joints, wrists; short lived headaches on right temple; This is a spontaneous report from a contactable consumer (patient). A 41-year-old non-pregnant female patient received bnt162b2 (BNT162B2, Solution for injection, lot number: EW0182) via an unspecified route of administration, administered in Arm Right on 19May2021 at 11:45 (at the age of 41-year-old) as dose 1, single for COVID-19 immunisation. The patient had no medical history. The patient's concomitant medications included Multi vitamin, vitamin D, B12, C and probiotic (other medications within 2 weeks of vaccination). Allergies to medications, food, or other products were reported as no. The patient was not pregnant at the time of vaccination. 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. On 22May2021 at 10:00, the patient experienced severe muscle fatigue in arms and legs on day 4 after shot and on an unknown date May2021 (reported as 10 days after shot), the patient experienced numbness and tingling started in feet and hands, tingling in thighs, vibration in chest replaced by pain in same spot, painful joints and wrists, short lived headaches on right temple. The patient did not receive treatment for the adverse events. Since the vaccination the patient was not tested for COVID-19. Outcome of the events were recovering.  Follow-up attempts completed. No further information expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia
Clinical narrative: Very sore shoulder after the vaccine and still dealing with it.; Slight weakness; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old male 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 24-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. It was unknown whether the patient received any other vaccines within four weeks prior to the vaccination. On an unknown date, the patient experienced very sore shoulder after the vaccine and still was dealing with it and slight weakness was also present. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events very sore shoulder after the vaccine and still dealing with it and slight weakness were recovered with sequelae.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Sore throat; Sniffles; She got sick the next day; This is a spontaneous report from a contactable consumer(reporter's sister).  A female patient of an unspecified age received 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 immunisation.  The patient medical history and concomitant medications were not reported. The caller states she has another sister with health conditions. Her sister with health issues got the vaccine and her arm wasn't even sore. She got sick the next day. Caller clarifies her sister was sick for a couple days with a sore throat and sniffles and that, but her arm wasn't sore at all because she laughed at the caller.  Information about Lot/batch number has been requested.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Chest discomfort for 3 weeks after first shot; This is a spontaneous report from a contactable physician. A 40-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on 15Apr2021 (at the age of 40-years-old), as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was unknown if the patient received any other vaccines within four weeks prior to the vaccination. On 15Apr2021, the patient experienced chest discomfort for 3 weeks after first shot. The event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event chest discomfort was 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.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I'm sick and need to reschedule.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received bnt162b2 (BNT162B2, Formulation: solution for injection, Lot number: not reported), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported that I was sick and need to reschedule on an unspecified date. The outcome of the event was unknown.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Compulsive hoarding, Crying, Head banging, Neuropsychiatric syndrome, Obsessive-compulsive disorder
Clinical narrative: Neuropsychiatric; OCD; Crying; Withholding food; Headbanging the same she has had after infections; This is a spontaneous report from a contactable consumer, the patient. A 15-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0181), via an unspecified route of administration on 17Jun2021 at 14:00 (at the age of 15-years-old), as a single dose for COVID-19 immunisation. Medical history included postural orthostatic tachycardia syndrome, paediatric acute onset neuropsychiatric syndrome and mast cell activation syndrome. The patient had known allergies to red dye. Concomitant medications included ivabradine hydrochloride (CORLANOR), pyridostigmine bromide (MESTINON), cromoglicate sodium (GASTROCROM), escitalopram oxalate (LEXAPRO) and clonidine (MANUFACTURER UNKNOWN); all from unknown dates for unknown indications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0180), via an unspecified route of administration on 27May2021 at 14:00 (at the age of 14-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 17Jun2021 at 20:00, the patient experienced neuropsychiatric, obsessive-compulsive disorder (OCD), crying, withholding food and headbanging, the same she has had after infections. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events which included treatment with NSAIDS and antihistamines. The clinical outcome of the events neuropsychiatric, obsessive-compulsive disorder (OCD), crying, withholding food and headbanging were resolving at the time of this report.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: Asthma/almost every night she has attacks; This is a spontaneous report from a contactable consumer (patient's father). A 13-year-old female patient received bnt162b2 (COMIRNATY, Solution for injection, Batch/Lot Number: Unknown), dose 2 via an unspecified route of administration on 18Jun2021 (last Friday) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included history of genetic asthma which she got from caller and has not had any recent attacks. No concomitant medications were reported. Caller stated since the second dose, almost every night she has attacks and the medicines Advair she is using daily and Albuterol does not seem to help, the attacks are more constant. Caller stated he does not hear hissing when he listens to her back/chest. Caller wanted to know if this is a reported side effect. Therapeutic measures were taken as a result of Asthma. Outcome of the event was not recovered.  Information about lot/batch number has been requested. Additional information has been requested.  Follow-up (20Aug2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 69-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0162) via an unspecified route of administration in the left arm on 13Apr2021 at 14:30 (at the age of 69-year-old) as a single dose for COVID-19 immunisation. Medical history included hypertension, coronary heart disease, lactose intolerant, IBD. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient took other medication in two weeks, but unspecified. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN6207) via an unspecified route of administration in the left arm on 22Mar2021 at 15:15 as a single dose for COVID-19 immunisation. 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 13Apr2021 the patient experienced tinnitus - ringing in both ears with high pitch which prolonged for 24 hours per day/ 7 days per week. No therapeutic measures were taken as a result of the event tinnitus. The clinical outcome of the event tinnitus was not resolved, at the time of this report.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on scalp area; This is a spontaneous report from a contactable consumer, the patient. A 41-year-old non-pregnant female 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 21Jun2021 at 10:30 (at the age of 41-years-old), as a single dose for COVID-19 immunisation. Medical history included migraine. Concomitant medications included unspecified off the counter pills for migraine from an unknown date. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 31May2021 at 10:30 (at the age of 41-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. The patient did not have any allergies to medications, food or other products. On 22Jun2021 at 06:00, the patient experienced hives on scalp area, 20 hours after the second vaccine shot. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. The clinical outcome of the event hives on scalp area was recovering at the time of this report.   The batch/lot numbers for, BNT162b2, were not provided and will be requested during follow up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: I am having numbness and tingling effect in my left arm where I had the shot. But only happen about 5 days ago. Its more than a month since the shot.; I am having numbness and tingling effect in my left arm where I had the shot. But only happen about 5 days ago. Its more than a month since the shot.; This is a spontaneous report from a contactable consumer, the patient. A 48-year-old male patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173) via an unspecified route of administration in the left arm on 17May2021 at 09:00 (at the age of 48-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. It was not reported if the patient received any other vaccines within four weeks prior to the vaccination. On 15Jun2021, the patient was having numbness and tingling effect in his left arm where he had the shot. But only happened about five days before the report. It was more than a month since the shot. 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 having numbness and tingling effect in left arm where the patient had the shot was not resolved at the time of this report.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Back disorder, Inflammation
Clinical narrative: One week after the second dose he had surgery for a "really bad issue" with his back; received two days of IV Decadron and a 10 day course of oral Decadron post surgery for inflammation; This is a spontaneous report from a contactable physician. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19-19 mRNA VACCINE, Formulation: Solution for injection, (Batch/Lot number was not reported)), dose 2 via an unspecified route of administration on Jan2021 as dose 2, single for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication, start and stop date were not reported. The patient experienced one week after the second dose he had surgery for a "really bad issue" with his back, received two days of iv Decadron and a 10-day course of oral Decadron post-surgery for inflammation. The patient underwent lab tests and procedures which included antibody test was negative on Jun2021. Therapeutic measures were taken as a result of one week after the second dose he had surgery for a "really bad issue" with his back (back disorder), received two days of iv Decadron and a 10-day course of oral Decadron post-surgery for inflammation (inflammation). The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: running a little fever; This is a spontaneous report from a contactable female consumer. This 86-Year-old female patient reported for herself.  An 86-Year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via unspecified rout on 21Jun2021 at 11:00 as dose 1, single for COVID-19 immunisation. The patient's medical history was not reported and concomitant medications included warfarin. On 22Jun2021, the patient was running a little fever. It was reported that "yesterday she got her vaccine, the Pfizer, and today she is running a little fever. Caller states she sees that's a little side effect, but they didn't say what to take. The fever is 100, it has decreased she believed a little bit. The patient was just concerned because she took the vaccine and saw that's one of the side effects. She wanted to know should she take Tylenol, it wasn't on the sheet they gave her. She doesn't see where they suggest any kind of medication and also reported that she is also on warfarin a blood thinner and she is allowed to take Tylenol but not ibuprofen. The patient underwent laboratory test included fever resulted 100 F. The outcome of the event was not resolved.  Follow-up attempts are completed. No further information is expected.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: Caller states after her and her dad received the vaccine they could no longer speak in a high tone.; This is a spontaneous report from a contactable consumer or other non hcp. An 83-years-old male patient received bnt162b2 dose 1 via an unspecified route of administration on an unspecified date (batch/lot number was not reported) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date patient reported that after she and her dad received the vaccine they could no longer speak in a high tone (dysphonia). The outcome of event unknown.    Follow-up (22Jun2021): This is a follow-up spontaneous report from a contactable consumer. The consumer reported for a 83-year-old male patient that.   Additional note:  The report is cross referenced to report ID: We all got it in January and February and then she got to march and we couldnt hit high notes. Her dad is the same way.    Follow-up attempts are completed. Information regarding the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021758858 same reporter/drug/AE, different patient.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea
Clinical narrative: Extreme fatigue; Headache; Severe joint pain; severe nausea; This is a spontaneous report from a contactable consumer, the patient. A 45-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0187) via an unspecified route of administration in the right arm on 15Jun2021 at 18:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation. Medical history included Takayasu arteritis. The patient did not have any allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included acetylsalicylic acid (MANUFACTURER UNKNOWN), calcium/ colecalciferol (CALCIUM D), multi-vitamins and vitamin d nos (MANUFACTURER UNKNOWN), all for unknown indication from an unknown date taken within 2 weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE: Lot Number: EW0176) via an unspecified route of administration in the right arm on 25May2021 at 18:00 (at the age of 45-year-old) as a single dose for COVID-19 immunisation.  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 15Jun2021 at 21:00 Within 3 hours of vaccination experienced severe nausea that needed medication. Approx. 24 hours post injection, on 16Jun2021 experienced extreme fatigue, headache, and severe joint pain that was so intense that she was unable to move without being in excoriating pain. Since the vaccination the patient had not been tested for COVID-19. Therapeutic measures were taken as a result of the reported events nausea, fatigue, headache and severe joint pain with zofran 8 mg and ibuprofen 500mg. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event severe nausea and headache was recovered on unknown date in Jun2021. The clinical outcome of the event extreme fatigue was recovered on 19Jun2021, 72 hours post onset. The clinical outcome of the event severe joint pain was recovered on 17Jun2021, 24 hours post onset.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Condition aggravated, Decreased activity, Depression, Mental disorder
Clinical narrative: ringing in ears; anxiety; depression; been detrimental to her mental health; hasn't been able to do anything, very inactive, and his getting worse; hasn't been able to do anything, very inactive, and his getting worse; This is a spontaneous report from a Contactable consumer (Patients husband).   A 60-year-old female patient received first dose of BNT162B2 (Solution for injection, lot number: unknown) via an unspecified route of administration around 06Mar2021 (reporter was unsure of the exact date patient received the first dose, but he says it was around 06Mar2021) at the age of 60-year-old, Time the Vaccination Was Given: in the early morning around 9AM, as dose 1, single for Covid-19 immunization. The patient did not have any medical history and concomitant medications. She had No other history with this product. It was stated that 2 days after first dose, the patient experienced ringing in her ears it was a reaction and it hasn't gone away. It has been detrimental to her mental health. She has had anxiety and depression, the ringing doesn't go away. She has been going to therapy but it doesn't go away. She has been taking medication to calm her down but it still doesn't. No further information provided. Reporter wanted to know if they know anything about it, if there is anyway to undo the vaccine or if Pfizer has found anything that is useful because at this point she is going through a lot and he is going to have to take her to the hospital. The patient didn't take the second dose because of the ringing in the ears. It was stated that she had not just ringing in her ears but anxiety and depression". She hasn't been able to do any-thing, very inactive, and getting worse. They have the potential of going to the hospital emergency. Reporter stated they "will continue to work with the physicians, trying to manage how we can handle this". Reporter also stated that the patient have talked with people (privacy) and they have experienced similar symptoms. The patient did not undergo any investigation assessment. There was not any additional Vaccines Administered on Same Date of the Pfizer Suspect: None, Prior Vaccinations (within four weeks prior to the first administration date of the suspect vaccine). The event did not lead to Emergency Room visit however lead to visit to a Physician Office. The outcome of the events was unknown.   Additional Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: ringing in ears; anxiety; depression; been detrimental to her mental health; hasn't been able to do anything, very inactive, and his getting worse; hasn't been able to do anything, very inactive, and his getting worse; This is a spontaneous report from a Contactable consumer (Patients husband).   A 60-year-old female patient received first dose of BNT162B2 (Solution for injection, lot number: unknown) via an unspecified route of administration around 06Mar2021 (reporter was unsure of the exact date patient received the first dose, but he says it was around 06Mar2021) at the age of 60-year-old, Time the Vaccination Was Given: in the early morning around 9AM, as dose 1, single for Covid-19 immunization. The patient did not have any medical history and concomitant medications. She had No other history with this product. It was stated that 2 days after first dose, the patient experienced ringing in her ears it was a reaction and it hasn't gone away. It has been detrimental to her mental health. She has had anxiety and depression, the ringing doesn't go away. She has been going to therapy but it doesn't go away. She has been taking medication to calm her down but it still doesn't. No further information provided. Reporter wanted to know if they know anything about it, if there is anyway to undo the vaccine or if Pfizer has found anything that is useful because at this point she is going through a lot and he is going to have to take her to the hospital. The patient didn't take the second dose because of the ringing in the ears. It was stated that she had not just ringing in her ears but anxiety and depression". She hasn't been able to do any-thing, very inactive, and getting worse. They have the potential of going to the hospital emergency. Reporter stated they "will continue to work with the physicians, trying to manage how we can handle this". Reporter also stated that the patient have talked with people (privacy) and they have experienced similar symptoms. The patient did not undergo any investigation assessment. There was not any additional Vaccines Administered on Same Date of the Pfizer Suspect: None, Prior Vaccinations (within four weeks prior to the first administration date of the suspect vaccine). The event did not lead to Emergency Room visit however lead to visit to a Physician Office. The outcome of the events was unknown.   Additional Information on lot/batch number has been requested.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Hiccups, Insomnia
Clinical narrative: Got hiccups for a few days after each dose; Loss of sleep; This is a spontaneous report from a contactable consumer or other non hcp (Patient).  A 74-years-old male patient received second dose of bnt162b2 (BNT162B2, PFIZER-BIOTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8730), via an unspecified route of administration in left upper arm on 01Apr2021 (Age at vaccination: 74-years-old) as single dose and first dose via an unspecified route of administration on 11Mar2021 (Age at vaccination: 74-years-old) (Batch/Lot Number: EP7534) as single dose for covid-19 immunization. Vaccination facility: Indoor Athletic Facility put on by county health department. No medical history and no concomitant medications was reported. vaccine was not Vaccine Administered at Military Facility. Did not receive Additional Vaccines on Same Date of the Pfizer Suspect. Did not receive any other vaccine within 4 weeks of covid-19 vaccine. It was reported that patient got both doses of the Pfizer BioNTech Covid-19 vaccine and he got hiccups for a few days after each dose. he was wondering if that has been reported. He shared that a friend had asked him if he had any side effects from vaccine, and he said no. Then said her brother had hiccups and is in his mid 80s, was bedridden for awhile. He had gotten the Moderna vaccine, though. Stated that there are reports on TV about a booster in the fall. Would he possibly have the same effects if he got a booster. Upon date 22Jun2021 it was reported that About 5 to 6 days after first dose he got the hiccups which lasted for 3 or 4 days. After second dose, something similar happened (hiccups), and he did not think much about it. Reports a loss of sleep since hiccups did not stop. Hiccups ended after the second dose around 08Apr2021 or 09Apr2021. The outcome for the event got hiccups for a few days after each dose was resolved on 2021 and for event loss of sleep outcome was reported as unknown at the time of this report.   Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Swelling and small lump on the neck; lump pains; This is a spontaneous report from a contactable consumer, the patient. A 38-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: Ew0182) via an unspecified route of administration in the left arm on 10May2021 at 10:00 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number:- EW0171) via an unspecified route of administration in the left arm on 19Apr2021 (at the age of 38-year-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date the patient experienced swelling and small lump on the neck. It appeared after vaccine dose 2, taken on 10th May 2021. The lump had been on the neck for more than 4 weeks then and not reducing. The lump pains when pressed hard. The event resulted in doctor or other healthcare professional office/clinic visit. The clinical outcome of the event swelling and small lump on the neck and lump pains was not recovered at the time of report.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Influenza, Pyrexia
Clinical narrative: flu symptoms; fever; headache; This is a spontaneous report from a contactable consumer.   This male consumer (patient) of unspecified age reported for himself that he received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: UNKNOWN) dose unspecified, via an unspecified route of administration on 07Jun2021 as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date in Jun2021, he patient experienced flu symptoms, fever and headache. He had his Covid Vaccine Pfizer on 07Jun2021 and has had flu symptoms, fever, headache for 5 days. Outcome was resolved on an unspecified date in Jun2021 for all the events. No additional information was provided and if you require additional information, please contact the reporter directly.   Information on Lot/Batch information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Irritability
Clinical narrative: After the first dose the caller got sick and really mean and irritable and out of character; After the first dose the caller got sick and really mean and irritable and out of character; This is a spontaneous report from a contactable other hcp (patient). A 56-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on 01Apr2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included regular aging stuff like sore shoulders and sore hips from an unknown date and unknown if ongoing, arthralgia from an unknown date and unknown if ongoing. The patients concomitant medications were not reported. The patient experienced after the first dose got sick and really mean and irritable and out of character on an unspecified date in Apr2021. This happened 2 or 3 days after the first dose which was on 01Apr2021. Patient could not be around people because she was so sick. It went away within a couple of days. The outcome of the events was recovered on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient's husband) reported for a 77-year-old female patient that:    A 77-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 2 via an unspecified route of administration on 24Mar2021 09:00 am (at the age of 77-years-old) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included breast cancer from an unknown date and unknown if ongoing 15 years ago, breast conserving surgery from an unknown date and unknown if ongoing, Is seen yearly and has been clean, metabolic surgery from an unknown date and unknown if ongoing, 10 years ago, diabetes mellitus from an unknown date and unknown if ongoing, caller is unsure if she still is since having gastric bypass surgery, tobacco user from an unknown date and unknown if ongoing. She quit 25 years ago. She is a cancer survivor.  The patient's concomitant medications were not reported.  The patient previously received bnt162b2 (BNT162B2, Solution for injection), dose 1 via an unspecified route of administration on 03Mar2021 (at the age of 77-years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. None any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s).  AE(s) did not require a visit to emergency room and physician office. The patient experienced sore arm on 24Mar2021.  The clinical course as follows, while reporting on self caller mentioned that his wife also got the vaccine and experienced a sore arm. Caller is not sure which arm his wife received the vaccine in.  His wife received the second dose on 24Mar2021. Her arm was sore on 24Mar2021 lasting until 25Mar2021. She recovered completely.  Caller states he and his wife went together to get the vaccine. None relevant test reported. The outcome of event recovered on 25Mar2021  This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Heat exhaustion
Clinical narrative: some possible increase in heat exhaustion; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported), via an unspecified route of administration on 06Jun2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On Jun2021, patient experienced some possible increase in heat exhaustion. Patient experienced some difficulty in carrying out usual exercises as compared to before. Physician mentioned some possible increase in heat exhaustion, but he was not positive that it was caused by the vaccine. Physician would like to have some information in regards to precaution that may be aware of regarding an increase in heat exhaustion after "x" amount of days after getting the vaccine. The outcome of the event was unknown.  Follow-up attempts are needed. Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021757388 Same reporter/ drug/ AE, different patient;US-PFIZER INC-2021757389 Same reporter/ drug/ AE, different patient;US-PFIZER INC-2021757390 Same reporter/ drug/ AE, different patient;US-PFIZER INC-2021755866 Same reporter/ drug/ AE, different patient
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Impaired work ability, Nausea, Tendon rupture
Clinical narrative: Not able to work/function past 03 PM; Ruptured Achilles tendon; Severe nausea; Extreme Fatigue/ exhaustion; The initial safety information received was reporting only non-serious adverse drug reactions. Upon receipt of follow-up information on 03Aug2021, this case now contains serious adverse reactions. Information processed together.   This is a spontaneous report from a contactable consumer, the patient. This 42-year-old female patient reported that she received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: Unknown) via intramuscular route in the left shoulder on 15Apr2021 at 15:30 (at the age of 42-years-old) as a single dose for COVID-19 immunization. Medical history included likely had COVID in Feb2020. The patient had no known allergies, no relevant family history, and no concomitant medications. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot: Unknown) via intramuscular route in the left shoulder on 17Mar2021 at 10:30 (at the age of 42-years-old) as a single dose for COVID-19 immunization. On 16Apr2021, the patient experienced extreme nausea and extreme fatigue, both reported as serious for disability. Patient had severe nausea and exhaustion for 13 days. Patient further described extreme nausea & fatigue resulting in inability to work functionally or care for children for 2 weeks; she was rendered useless by 3 pm each day, earlier on others. On 19Apr2021, patient had a ruptured Achilles tendon and experienced exhaustion. There was no treatment received for the events. The clinical outcome of extreme nausea and extreme fatigue/exhaustion was recovered on 30Apr2021, of ruptured Achilles tendon was not recovered, of not able to work/function past 3 PM was unknown. The patient was not COVID tested post vaccination.   The lot/batch number for the vaccine, BNT162b2, was not provided and will be requested during follow-up.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Breast enlargement, Breast pain
Clinical narrative: Breasts extremely sore and enlarged.; Breasts extremely sore and enlarged.; This is a spontaneous report from a contactable consumer (patient). An 18-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number and expiration date: Not reported), via an unspecified route of administration on 15Jun2021 (age at vaccination: 18-years-old) as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On an unknown date in Jun2021, the patient breasts extremely sore and enlarged. It was going on day 7 of pain and treated with Ice packs and Tylenol. Outcome of the events was recovering.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Genital rash
Clinical narrative: Development of a rash on and around genitals; This is a spontaneous report from a contactable consumer, the patient. A 46-year-old male patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0158) via an unspecified route of administration in the left arm on 17Jun2021 at 10:30 (at the age of 46-years-old), as a single dose for COVID-19 immunisation. Medial history and concomitant medications were not reported. 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. It was unknown if the patient had allergies to medications, food, or other products. On 18Jun2021 at 01:00, the patient had development of a rash on and around genitals. The event resulted in doctor or other healthcare professional office/clinic visit. It was unknown whether therapeutic measures were taken as a result of the event. The clinical outcome of the event development of a rash on and around genitals was not recovered at the time of this report.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Hypoaesthesia, Pain in extremity
Clinical narrative: Numbness and pain in entire right arm, right side of head; Pain in entire right arm,; Pain right side of head,; Severe exhaustion for 3 days post vaccination; This is a spontaneous report from a contactable consumer. A 39-year-old non-pregnant female patient received unknown dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the right arm on an unknown date in Apr2021(at the age of 39-years-old) as a single dose for COVID-19 immunisation. Other medical history not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was unknown weather the patient had received any other vaccines within four weeks prior to the vaccination. On an unknown date in 2021, the patient experienced numbness and pain at entire right arm, right side of head, and severe exhaustion for three days post vaccination. 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 numbness and pain in entire right arm, right side of head, and severe exhaustion for three days post vaccination was recovered on unknown date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pyrexia
Clinical narrative: Chills; Fever; Sweats; Severe headache; This is a spontaneous report from a non-contactable consumer, the patient. A 28-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0196) via an unspecified route of administration in the left arm on 21Jun2021 at 11:00 (at the age of 28-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications taken within two weeks of vaccination were not reported. The patient previously took first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ew0191) via an unspecified route of administration in the left arm on 01Jun2021 (at the age of 28-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 an unknown date in Jun2021, the patient experienced chills, fever, sweats, severe headache. The clinical outcome of the events chills, fever, sweats, severe headache was not resolved at the time of report.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain in extremity, Vomiting
Clinical narrative: Very hurtful arm, barely moving; Throwing up; Teeth were chattering/Chills; Feeling very weak; This is a spontaneous report from a contactable consumer or other non-healthcare professional. This case is for reporter's husband. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unspecified date, the patient experienced very hurtful arm, barely moving, throwing up, chills/teeth were chattering and feeling very weak. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021758715 Same reporter/drug/AE, different patient;US-PFIZER INC-2021758769 Same reporter/drug/AE, different patient
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Pain in extremity, Vomiting
Clinical narrative: Very hurtful arm, barely moving; Throwing up; Chills/Teeth were chattering; Feeling very weak; This is a spontaneous report from a contactable consumer. This case is for reporter's daughter. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization and experienced no adverse event. On an unspecified date, the patient experienced very hurtful arm, barely moving, throwing up, chills/teeth were chattering and feeling very weak. The outcome of the events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021758768 Same reporter/drug/AE, different patient;US-PFIZER INC-2021758715 Same reporter/drug/AE, different patient
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus in both ears in the form of ringing.; This is a spontaneous report from a contactable consumer, the patient. A 40-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWO180) in the left arm on 24May2021 at 18:30 (at the age of 40-years-old) as a dose for COVID-19 immunisation and patient also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EWO217) in the left arm on 14Jun2021 at 18:45 (at the age of 40-years-old) as a dose for COVID-19 immunisation. Medical history included sulfonamide allergy. Concomitant medications included mefenamic acid (ADVIL); for unknown indication from unknown date and unknown if ongoing. 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 28May2021 at 21:00, the patient experienced tinnitus in both ears in the form of ringing. The event 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 event. The clinical outcome of the event tinnitus in both ears in the form of ringing was not recovered at the time of this report.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: had blood spew out of the injection site; This is a spontaneous report from a contactable consumer or other non-healthcare professional. This consumer reported for 3 patients, this is 2 of the 3 reports. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Pfizer Covid-19 Vaccine, Solution for injection), dose 2, via an unspecified route of administration on 23Jan2021 (Batch/Lot number: E19126 and Expiry date was not reported) as DOSE 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 23Jan2021, the patient experienced had blood spew out of the injection site. It was explained that the bleeding lasted about an hour, it was not a lot but shot right out of the puncture, where the jab was at the injection site. The reporter wanted to know if he should get a third dose of the vaccine. It was reported that when he received the 2nd dose the patient lost a lot of blood, there was excess bleeding at the injection site. The caller stated that the tech put the needle in and afterward states that he was the 3rd patient that had blood spew out of the injection site. No other information provided for this statement as the caller declined to complete the report. The clinical outcome of the event was unknown.  Information on Lot/Batch number was available. Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021760093 same reporter/product/event, different patient