chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: her husband has underlying medical conditions; and got COVID before he got the vaccine; and had heart problems after the infection.; This is a spontaneous report from a contactable consumer (patient's wife). A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included underlying medical conditions and got COVID before he got the vaccine. The patient's concomitant medications were not reported. It was reported that the patient had underlying medical conditions; and got COVID before he got the vaccine; and had heart problems after the infection. Outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Age: 67.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Feeling abnormal, Illness
Clinical narrative: I was not super sick; A little off; This is a spontaneous report from a contactable consumer from a 67-year-old patient of unspecified gender received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; lot number unknown) via an unspecified route of administration on an unknown date (at the age of 67-years-old) as a single dose for COVID-19 immunisation; and started to receive estrogens conjugated (PREMARIN) via an unspecified route of administration from an unknown date at an unknown dosage for an unknown indication. Medical history and concomitant medications were not reported. The patient called to obtain a refill for their estrogens conjugated and stated they had received their Pfizer vaccine and they were not super sick, but a little off, but didn't get the flu or bad symptoms; further reporting other people did. The action taken with estrogens conjugated and the outcomes of the events were unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: patient had a reaction at that site; This is a spontaneous report from a contactable pharmacist. This Pharmacist reported for a patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 vaccine, formulation: solution for injection; Lot number and expiration date 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 was not reported. The patient's concomitant medications were not reported. The reporter reported that they have a patient that was seen by a different organization and on an unspecified date, the patient had a reaction at that site. The allergist would like to start by administering 10% of the dose. The reporter enquired about any information on further dilution so that we could accurately measure that dose. The outcome of the event was unknown.  Information on the Lot/Batch number has been requested.  Follow-up (28Jun2021): This follow-up is being submitted to notify that the batch/lot number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 12.0
Sex: U
Vaccine: COVID19
Symptoms: Overdose, Pain in extremity
Clinical narrative: The 6 Patients received full vial or 6 doses each of the Pfizer COVID Vaccine; Sore Arm; This spontaneous report from a contactable nurse reporting same events under the same suspect product for six patients. This is one of six reports. A 12-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0191 and expiration date was not provided), via an unspecified route of administration, administered in Arm Right on 20May2021 at 09:16 (at the age of 12-year-old) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0183 and expiration date was not provided) for covid-19 immunization. The patient received full vial or full doses of the Pfizer COVID vaccine on 20May2021 and had sore arm. Caller was a Registered Nurse and a Clinic Manager at a Medical facility. They had a dosage error involving 6 patients. The 6 Patients received full vial or 6 doses each of the Pfizer COVID Vaccine. Patients were 12, 16, 17, 18 and 32 years old and still waiting for additional information of the last patient. She currently didn't had data on the genders of the patients. She agreed to be called back for additional AE reporting. Outcome of the event sore arm was recovered on an unknown date in 2021.  Information on the lot/batch number has been requested.  Follow-up (27May2021): This is a spontaneous report from a Non-clinical study report form via a contactable Nurse included that: Therapy dates of the suspect product updated, anatomical location where the vaccine was administered (right arm), Batch/Lot number updated, added new event (sore arm), onset date of the event, outcome of the event.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.   Follow-up (16Jun2021): New information received from a Non-clinical study report form via a contactable nurse included that: No new adverse events were reported by the patient.   Follow-up attempts are completed. No further information is expected.  Follow-up (01Jul2021): This is a spontaneous report from a Non-clinical study report form via a contactable Nurse included that: No new adverse events were reported by the patient. New information included as patient received their 2nd dose today. Lot/ batch number: EW0183  Follow-up attempts are completed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021616982 Same reporter/product/event, different patient;US-PFIZER INC-2021617272 Same reporter/product/event, different patient;US-PFIZER INC-2021617273 Same reporter/product/event, different patient;US-PFIZER INC-2021617274 Same reporter/product/event, different patient;US-PFIZER INC-2021617275 Same reporter/product/event, different patient
Age: 77.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Vitreous floaters
Clinical narrative: floaters; achy all over; Exhausted; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 77-year-old patient of an unspecified gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Expiry Date: unknown, Batch/Lot number: EL9267), via an unspecified route of administration, administered in arm right on 19Feb2021 11:00 (at the age of 77years) as single dose for covid-19 immunisation. Medical history included gluten allergy from 2009 to an unknown date, lesion in pancreas from 2009 to an unknown date. The patient's concomitant medications were not reported.  Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection; Lot number: EL8982), via an unspecified route of administration, administered in the right arm on 29Jan2021 14:00 (at the age of 77years) as single dose for COVID-19 immunisation. No additional vaccines administered on same date of the Pfizer Suspect. No prior vaccinations (within 4 weeks). On 19Feb2021 at 15:00, the patient experienced exhausted, floaters, achy all over. No physician room or emergency room visits. The outcome of events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash, Sunburn
Clinical narrative: She experience the rashes after taking the 2nd dose; I had a small bumps around on my neck; it look like a sun burn, redness; I had a small bumps around on my neck; it look like a sun burn, redness; This is a spontaneous report from a contactable consumer (patient herself) reported that a female patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EW0185) via an unspecified route of administration on 15May2021 as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 27Apr2021 for COVID-19 immunization. It was reported as patient stated that on 20May2021 she experienced rashes after taking the 2nd dose on and "she took 2nd vaccine on Saturday on 15May2021 and yesterday she had a small bumps around on her neck, toady she noticed and it look like a sun burn, redness so she is saying that it might be the side effect of the vaccine or it might be something else and she is allergic too, but she haven't had been experience allergy before". The outcome of the events was unknown.  No Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Exposure to SARS-CoV-2, Illness
Clinical narrative: She always has allergies but this seems to be more serious; little more sick than usual; This is a spontaneous report from a contactable consumer. This consumer reported for a patient  that a 13-years-old female patient received bnt162b2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: unspecified), via an unspecified route of administration on unspecified date as single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. She had allergy (not specified).  about seven days ago and he has Covid 19 right now, tomorrow my  was supposed to get her Pfizer shot (It was not clarified whether the shot was first or second shot) and I was wondering should I take her and have her do the quick overnight Covid test first to see if she has the Covid thing and also can you take the Covid vaccination if you were already sick. She seems to be little more sick than usual. She always has allergies, but this seems to be more serious. The outcome of the events was unknown.Follow-up (21May2021): This follow-up contains no new medically significant information.  Follow-up (21May2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported for a patient that: COVID 19 exposure between doses of the Pfizer Covid Vaccine. No follow-up attempts are possible; information about lot batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Pain, Pain in extremity
Clinical narrative: Little bit of a sore arm; Body achiness; I realized after I left the nurse gave my injection subcutaneously; This is a spontaneous report from a contactable consumer (patient herself). A 38-year-old female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine; formulation: solution for injection; Lot Number: ER8736; NDC number, UPC number and Expiry Date : Unknown), dose 2 via an unspecified route of administration administered in left arm on 20May2021 at 10:00 AM (at the age of 38 years) as dose 2, single for covid-19 immunisation. Medical history included migraine; patient stated that she had migraine since she was 13. So, probably like 25 years ago, 1995 or 96. Concomitant medication included propranolol taken for an unspecified indication at 10 mg twice a day from an unknown date and patient mentioned that she was on a really low dose. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EW0179) on 29Apr2021 (at the age of 38-years-old), as a dose 1, single for COVID-19 immunisation and there was no reaction on previous exposure to vaccine. Patient reported that she got the second dose of the Covid vaccine yesterday, she realized after she left the nurse gave her injection subcutaneously on 20May2021. She also reported that she had her vaccination done yesterday at 10 'O' clock. The body achiness about 2 am last night, the only, she has a sore arm, a little bit of a sore arm and then she had very mild just little bit of aching today but that's all. So, just normal kind of expected reaction to vaccine on 21May2021. There is no PQC reported. No therapeutic measures were taken as a result of the events. The patient has not received any treatment. The outcome of the events little bit of a sore arm and body achiness was not recovered and the event ''I realized after I left the nurse gave my injection subcutaneously'' was unknown at the time of the report.  Follow-up attempts are needed. Further information is requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain lower, Asthenia, Cough, Ear discomfort, Malaise
Clinical narrative: last night her ear glands that are under her ear at the neck area hurt her which is close to jaw bone meets her ear; feels achy all over her body; Sore throat; Cough; do not have any strength; intestines feels like she is cramping; feeling very sick; This is a spontaneous report from a Pfizer sponsored program (patient). A 67-year-old consumer female reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0170) via an unspecified route of administration on 19May2021 at 10:00 hours (at age of 67-year-old female), in right arm as dose 2, single for COVID-19 immunization. Medical history of the patient included hysterectomy (start date and ongoing status unknown). It was mentioned that there was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines were administered and had no relevant family history. The patient did not receive any prior vaccines within 4 weeks. No adverse event following prior vaccinations. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0153) via an unspecified route of administration on 28Apr2021 (at age of 67-year-old female) in right upper arm as dose 1, single for COVID-19 immunization. On 19May2021 patient felt sick. Caller was wondering since her grandchildren would visit her today and wanted to know if her grandchildren would be contagious since she was sick. The same day about 6 hours after the shot is when it started caller stated she had a sore throat. She had cough, ten hours after the shot she felt achy all over her body, did not have any strength, her intestines felt like she was cramping, caller stated she knew that they were not menstrual cramps since she had a hysterotomy. On 20May2021 her ear glands that were under her ear at the neck area hurt her which was close to jaw bone meets her ear. Caller inquired if it was ok to call her family doctor would they know the answer. Caller stated she would just call her doctor The patient received treatment with Tylenol. She did not require any emergency room and physician office visit. No relevant test was reported. The outcome of felt sick was unknown and for intestines feels like she is cramping was recovered on 20May2021 and the other events had not recovered. Additional information was requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pain
Clinical narrative: last night her ear glands that are under her ear at the neck area hurt her which is close to jaw bone meets her ear; feels achy all over her body; Sore throat; Cough; do not have any strength; intestines feels like she is cramping; feeling very sick; This is a spontaneous report from a Pfizer sponsored program (patient). A 67-year-old consumer female reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0170) via an unspecified route of administration on 19May2021 at 10:00 hours (at age of 67-year-old female), in right arm as dose 2, single for COVID-19 immunization. Medical history of the patient included hysterectomy (start date and ongoing status unknown). It was mentioned that there was no history of all previous immunization with the Pfizer vaccine considered as suspect and no additional vaccines were administered and had no relevant family history. The patient did not receive any prior vaccines within 4 weeks. No adverse event following prior vaccinations. There were no concomitant medications. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: EW0153) via an unspecified route of administration on 28Apr2021 (at age of 67-year-old female) in right upper arm as dose 1, single for COVID-19 immunization. On 19May2021 patient felt sick. Caller was wondering since her grandchildren would visit her today and wanted to know if her grandchildren would be contagious since she was sick. The same day about 6 hours after the shot is when it started caller stated she had a sore throat. She had cough, ten hours after the shot she felt achy all over her body, did not have any strength, her intestines felt like she was cramping, caller stated she knew that they were not menstrual cramps since she had a hysterotomy. On 20May2021 her ear glands that were under her ear at the neck area hurt her which was close to jaw bone meets her ear. Caller inquired if it was ok to call her family doctor would they know the answer. Caller stated she would just call her doctor The patient received treatment with Tylenol. She did not require any emergency room and physician office visit. No relevant test was reported. The outcome of felt sick was unknown and for intestines feels like she is cramping was recovered on 20May2021 and the other events had not recovered. Additional information was requested.
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: Had a fast heartbeat; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EW0158 and Expiration Date: unknown), via an unknown route of administration, administered in left arm on 19May2021 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On 19May2021, the patient received vaccine and about 3 hours after she had a shot. She had a fast heartbeat and then the following day on 20May2021 it happened again and she had a fast heartbeat about 12:45 in the afternoon. When she talked to the nurse, nurse said that the second dose was a little stronger. Outcome of event was recovered on an unspecified date in May2021.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia, Sensitive skin
Clinical narrative: Fever, chills, sensitive skin, extremely tired; Fever, chills, sensitive skin, extremely tired; Fever, chills, sensitive skin, extremely tired; Fever, chills, sensitive skin, extremely tired; This is a spontaneous report from a contactable consumer.   A 46-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 21May2021 10:00 (age at vaccination 46-year-old) as dose 2, single for covid-19 immunisation in pharmacy or drug Store. The patient was not pregnant at the time of vaccination. Medical history included crohn's disease and allergy to chemicals (Sulfate). Concomitant medications included levocetirizine dihydrochloride (XYZAL), sertraline hcl and omeprazole (PROTONIX [OMEPRAZOLE]) for an unspecified indication received within 2 weeks of vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 30Apr2021 as dose 1, single for covid-19 immunisation. 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 08:00, the patient experienced fever, chills, sensitive skin and extremely tired . Since the vaccination, the patient was not tested for COVID-19. No treatment medication was received for the adverse events. The outcome of the events was not resolved.  Information about batch/lot is requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy, Herpes zoster, Intermenstrual bleeding, Menstruation irregular, Ultrasound scan
Clinical narrative: got my period again; got my period again; Shingles; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 71-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via intramuscular, administered in Arm Left (she thinks) on 26Feb2021 as DOSE 2, SINGLE for covid-19 immunisation (possibly received second shot at 28 days). The first shot of bnt162b2 was received 28 days before dose 2. The patient medical history and concomitant medications were not reported (When probed for any concomitant products and medical conditions, the caller states she didn't change anything, every thing was the same). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not having any other event. The patient all of a sudden got period again on an unknown date. The patient also reported also got shingles about a week ago on 16May2021 (Right after the shot, she had gynecological problems. She is 71 years old and all of a sudden, she got her period again. A week ago, she got shingles. She just wanted to confirm if  things like this has occurred with other people). Biopsies were taken and they were negative. She also had a sonogram done (When probed for results of this testing, the caller states she was told she has a very thin lining and if she starts bleeding again, she may have to have surgery). She was informed if her period started again, she might have to have surgery. She confirms she is not bleeding at this point. Right now, everything is okay. It's just that she is 71 years old and all of sudden, she got her period again. She still has the shingles but she is not contagious as she took viral medication and just finished it. She explains she went to an urgent care. She clarifies Sunday, 16May2021, she woke up and all the shingles were on the left hand side of her face. She had a visit with her primary care physician for the event (got my period again). Outcome of all the events was unknown.  Information on the lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Anal pruritus, Oral pruritus, Pruritus, Pruritus allergic, Vulvovaginal pruritus
Clinical narrative: Itching inside nose, mouth, vagina , rectum and then skin; Itching inside nose, mouth, vagina , rectum and then skin; Itching inside nose, mouth, vagina , rectum and then skin; Itching inside nose, mouth, vagina , rectum and then skin; Itching inside nose, mouth, vagina , rectum and then skin; This is a spontaneous report from a contactable other health care professional (patient) reported that a 55-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6204), via intramuscular, administered in left arm on 19Mar2021 at 08:00 AM as DOSE 1, SINGLE for covid-19 immunisation. Medical history included hypertension, psoriasis; both were from an unknown date and unknown if ongoing. known allergies includes sulfa. At Hospital facility where the most recent COVID-19 vaccine was administered. The patient was not receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medications included losartan taken via oral at 50 mg for hypertension from an unspecified start date and ongoing; loratadine (CLARITINE) taken for an unspecified indication, start and stop date were not reported, which were received by the patient within 2 weeks of vaccination. On 19Mar2021 at 05:00 PM, the patient experienced itching inside nose, mouth, vagina, rectum and then skin. Prior to vaccination, the patient was not diagnosed with COVID-19, since the vaccination, the patient was not tested for COVID-19. Therapeutic measures were taken as a result of the events with Benadryl. The report seriousness was non serious. Outcome of the events was recovered on an unspecified date in 2021.
Sex: U
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: 18 teens in the State, had suffered "heart inflammation"; This case has been considered invalid ICH- Reporter with no first-hand knowledge  This is a spontaneous report from a Pfizer sponsored Program. A non-contactable consumer reported for 18 adolescents approx 12-15 years old, unspecified gender patients that :  Suspect Product(s):  Name:  Pfizer Covid Vaccine (BNT162B2)  Verbatim and event description: Please be aware I heard on yesterdays 11:00 o clock pm News Program with PRIVACY and PRIVACY a statement concerning receipt of Pfizer BioNtech COVID-19 vaccine. Among adolescents 12-15 years old who have received Pfizer-BioNtech COVID - 19 vaccine (not sure 1 or 2 doses), 18 teens in the State had suffered "heart inflammation" I have no further information, there was no other background information provided, and I have no first hand knowledge of any of the teens who suffered this adverse event.  No follow-up attempts are possible. Information about batch number cannot be obtained.  Follow-up (30May2021): This case remains invalid since since the reporter cannot be identified for direct/private contact (internet source)  This is a spontaneous report from a Pfizer sponsored Program. A non-contactable consumer of unspecified age or gender reported that:  Suspect Product(s):  Name:  Pfizer Covid Vaccine (BNT162B2) Verbatim and event description:  Could also be caused by an experimental gene therapy "vaccine"  No follow-up attempts are possible. Information about batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Viral infection
Clinical narrative: Shingles; Mom has some kind of virus on her body; This is a spontaneous report from a non-contactable consumer or other non hcp via Pfizer sponsored Program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 10May2021 (Batch/Lot number was not reported) as first dose, single for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced shingles on an unspecified date in May2021 and had some kind of virus on her body on an unspecified date in 2021. The reporter stated that her mother received her first vaccine on 10May2021 and developed shingles afterwards and wanted to know if she can take the second vaccination, scheduled on 31st, the next Monday. At the time of reporting, patient was receiving like a viral medication (Unspecified Medication; Intent: Treatment). Reporter did not know what it does to the shingles. Patient had a seven days prescription plus she had another months of the medication for this. Reporter mentioned that patient never had these things before, reporter did not want to say that was caused by the vaccine. Patient went to the Doctor yesterday and they find out that there was shingles. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Headache, Otic examination, Pyrexia, Tinnitus
Clinical narrative: Ringing in both ear persistent and painful; my chronic tinnitus in the right ear, which was a low volume nuisance, got louder and continues to this day/Extreme Ringing right ea/Ringing Left ear/Ringing in both ear persistent and painful; Had low grade fever; Headache; The initial safety information received was reporting only non-serious adverse drug reactions, Upon receipt of follow-up information on 12Jul2021, this case now contains serious adverse reaction. Information processed together.  This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) (at 69 years of age), dose 2 via an unspecified route of administration, administered in arm right on 17Mar2021 14:00 (Batch/Lot Number: EL9267) as DOSE 2, SINGLE for COVID-19 immunisation. Medical history included hypothyroidism and known allergies to Steri-strips. Concomitant medications included levothyroxine sodium (LEVOTHYROXIN) and atorvastatin calcium (LIPITOR [ATORVASTATIN CALCIUM]). The patient was not pregnant. Historical vaccine included BNT162B2 (at 69 years of age), dose 1 (lot number: EL9269) on 24Feb2021 02:00 PM, administered in right arm for COVID-19 immunization with no reaction. The patient had no other vaccine in four weeks and no prior vaccinations. She had no covid prior to vaccination. She had not been tested post vaccination. The patient experienced chronic tinnitus in the right ear, which was a low volume nuisance, got louder and continues to this day on 18Mar2021 with outcome of not recovered; had low grade fever and headache on 18Mar2021 with outcome of recovered. It was reported that after the 2nd dose, the patient had chronic tinnitus in the right ear, which was a low volume nuisance, got louder and continues to this day. She mentioned that it was unbearable at different times of the day. Her left ear started experiencing tinnitus after the 2nd dose. Prior to that, that ear never had tinnitus. It was mentioned that the patient had extreme ringing in right ear started 24 hours after 2nd vaccine had low grade fever and headache also but that went away in 2 days. Ringing in both ear persistent and painful. The patient underwent lab test and procedure wherein a primary doctor checked the ears and found no inventions or blockage. The event Extreme Ringing right ear/Ringing Left ear are reported serious- Persistent/ significant/ disability/Incapacity. No treatment received for the events. The outcome of tinnitus and ear pain was not recovered; while low grade fever and headache recovered on 20Mar2021.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Decreased appetite, Fatigue, Insomnia, Migraine
Clinical narrative: hair loss; migraine; Nausea; Fatigue; increase weight gain; no appetite; shooting pain in the muscles; Insomnia for 9 days; This is a spontaneous report from a contactable nurse. A 57-year-old female nurse (patient) reported for herself.  A 57-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0183, Expiration date: Unknown), via intramuscular route, administered in left arm (deltoid) on 20May2021 16:00 (at the age of 57-years-old) as dose 2, single for covid-19 immunisation in public health clinic/veterans administration facility. Medical history included known allergies. The concomitant medications were none. 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. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0179, Expiration date: Unknown), via intramuscular route, administered in deltoid on 29Apr2021 (at the age of 57-years-old) as dose 1, single for covid-19 immunisation and no problem with first injection. On 20May2021 at 02:00 Am, the patient experienced insomnia for 9 days. On 21May2021 at 02:00, the patient experienced, hair loss, migraine, nausea For 4 weeks, fatigue, increase weight gain, no appetite, shooting pain in the muscles. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of insomnia for 9 days, migraine with smudging with SAGE disease and Tylenol 500 mg respectively. The event Insomnia and nausea were reported as Persistent/ Significant disability/ Incapacity, Important medical event, migraine was reported as Persistent/ Significant disability/ Incapacity, and hair loss was reported as Important medical event. The outcome of the event migraine was resolved on an unspecified date in 2021 and nausea was resolved on 15Jun2021, hair loss was not resolved and other events were resolving.  Follow-up attempts are needed. Further information is requested.  Follow-up: This is a follow up-spontaneous report from a contactable other HCP (nurse). This other HCP (nurse) reported in response to HCP letter via follow-up letter:; Sender's Comments: Considering a plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported Insomnia, hair loss and Migraine cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Weight increased
Clinical narrative: hair loss; migraine; Nausea; Fatigue; increase weight gain; no appetite; shooting pain in the muscles; Insomnia for 9 days; This is a spontaneous report from a contactable nurse. A 57-year-old female nurse (patient) reported for herself.  A 57-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0183, Expiration date: Unknown), via intramuscular route, administered in left arm (deltoid) on 20May2021 16:00 (at the age of 57-years-old) as dose 2, single for covid-19 immunisation in public health clinic/veterans administration facility. Medical history included known allergies. The concomitant medications were none. 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. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EW0179, Expiration date: Unknown), via intramuscular route, administered in deltoid on 29Apr2021 (at the age of 57-years-old) as dose 1, single for covid-19 immunisation and no problem with first injection. On 20May2021 at 02:00 Am, the patient experienced insomnia for 9 days. On 21May2021 at 02:00, the patient experienced, hair loss, migraine, nausea For 4 weeks, fatigue, increase weight gain, no appetite, shooting pain in the muscles. Since the vaccination, the patient has not been tested for COVID-19. Therapeutic measures were taken as a result of insomnia for 9 days, migraine with smudging with SAGE disease and Tylenol 500 mg respectively. The event Insomnia and nausea were reported as Persistent/ Significant disability/ Incapacity, Important medical event, migraine was reported as Persistent/ Significant disability/ Incapacity, and hair loss was reported as Important medical event. The outcome of the event migraine was resolved on an unspecified date in 2021 and nausea was resolved on 15Jun2021, hair loss was not resolved and other events were resolving.  Follow-up attempts are needed. Further information is requested.  Follow-up: This is a follow up-spontaneous report from a contactable other HCP (nurse). This other HCP (nurse) reported in response to HCP letter via follow-up letter:; Sender's Comments: Considering a plausible temporal relationship, a possible contributory role of suspect product BNT162B2 to the reported Insomnia, hair loss and Migraine cannot be excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Face was on fire/ Chin burning; This is spontaneous report received from a contactable consumer (patient mother reported for her daughter). A 13-year-old female patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 18May2021 as dose 1, single (at the age 13-years-old) for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Mother had 3 teenagers. 2 teens got the Covid vaccine last Tuesday (18May2021). The 16-year-old and 13-year-old both had substantial side effects. She did not seem to be hearing about them. She did not make the connection to the vaccine until her daughter had the same symptoms the night of her vaccine. They both had the same effects.  Her daughter experienced it even worse than her son. She had 3 teenagers. One is 16, and he got the vaccine approximately 2 weeks ago. The other 2 teens got the vaccine last Tuesday (18May2021). The 16-year-old and 13-year-old both had substantial side effects. She did not seem to be hearing about them. She was concerned about whether they should get the second dose based on their reaction. She asked what Pfizer recommended. She was a social worker. Her son had severe allergies, and they knew that when he went in there. They were watching him. Upon getting it, 15 minutes later his chin was burning. It was not significant and did not get any worse. Then for the next 4 days his face was on fire to the point where he could not even use soap or moisturize because it was really painful. She did not make the connection until her daughter had the same symptoms the night of her vaccine on 18May2021. They both had the same effects. Her son had his first dose of the vaccine on 12May2021. The burning in his chin went away. She was not sure when it went away. It did not last that long. His face started the night he got the vaccine. It lasted for about 4 days. It has totally gone away. She was just wondering, she was pretty savvy in terms of reading and she has not seen this reaction publicized. Both her 16-year-old and her 13-year-old were in the later stage of puberty. That was the only other correlation between her two kids that she can imagine. They did not have the vaccine on the same day, so it was not the batch. Her daughter experienced it even worse than her son. She hoped Pfizer is figuring all of this out. The adverse event did not result emergency room or physician office visit. The outcome of the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation
Clinical narrative: Chin burning/ face on fire; This is a spontaneous report from a contactable consumer. A 16-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch Number/Lot: EW0162; Expiration Date: 31Jul2021), dose 1 via an unspecified route of administration, administered in Arm Left on 12May2021 as single dose for COVID-19 immunisation. Medical history included ongoing asthma. The patients concomitant medications were not reported. The patient not received any other vaccinations within four weeks prior to the COVID-19 vaccine. The patient experienced chin burning/ face on fire on 12May2021. She has 3 teenagers. One is 16, and he got the vaccine approximately 2 weeks ago. The other 2 teens got the vaccine last Tuesday. The 16 year old and 13 year old both had substantial side effects. She does not seem to be hearing about them. They both received their vaccines at the same medical facility. She is concerned about whether they should get the second dose based on their reaction. She asks what Pfizer recommends. Reporter stated that her son has severe allergies and they knew that when he went in there. They were watching him. Upon getting it, 15 minutes later his chin was burning. It was not significant and did not get any worse. Then for the next 4 days his face was on fire to the point where he could not even use soap or moisturize because it was really painful. She did not make the connection until her daughter had the same symptoms the night of her vaccine. The burning in his chin went away. She is not sure when it went away. It did not last that long and face on fire His face started the night he got the vaccine. It lasted for about 4 days. It has totally gone away. The patient did not visited Emergency Room and Physician Office. The outcome of the event was recovered.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: very tired; This is a spontaneous report received from a contactable other health care professional and a contactable consumer. A 58-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), dose 1 via an unspecified route of administration on 21May2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient reports that continues taking IBRANCE 125 mg daily (with faslodex) but md changed to 2 weeks on then 1 week off (off label dosing per md, change in frequency due to ongoing low blood count and schedule of 2nd dose of COVID-19 vaccine to coincide while she was on the week off - 11Jun2021, 1st dose given on - 21May2021) and then she will resume frequency of 21 days on then 7 days off as prescribed. states "very tired" after 1st dose of COVID-19 vaccine but has resolved. reports since start of therapy, low platelet count has improved; mild nosebleed (present prior) has resolved since last report. md aware of all. no other information provided. (previous dose: 125 mg daily for 21 days on then 7 days off- 09Dec2020 to May2021).  Information on the lot/batch number has been requested.  Follow-up (02Jul2021): 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 completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Hypokinesia
Clinical narrative: hard for him to get up; This is a spontaneous report from a contactable consumer (patient). Report 2 of 2. A male patient of unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on 14Feb2021 as single dose for covid-19 immunisation. The patient medical history included Parkinson's disease and was diagnosed 6 or 7 years ago and back problems when he was a kid. The patient concomitant medications were not reported. On unspecified date, the patient experienced hard for him to get up. His wife and him got the first dose of the vaccine on 14 Feb2021. The second shot did not bother him but his wife was in the ER 8 hours later and was on a ventilator and died. The outcome of the event was unknown.  Information about batch/lot number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dyspnoea, Feeling hot, Limb discomfort, Pain in extremity
Clinical narrative: dizziness; shortness of breath; her throat is tight; Sore Arm; Swollen; Warm/Hot; Painful; has a sore arm with swelling and warmth; has a sore arm with swelling and warmth; Sore Arm; Swollen; Warm/Hot; Painful; This is a spontaneous report from a contactable consumer reporting for herself. A 42-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 27May2021 10:00 (Batch/Lot number was not reported) as single dose (age at vaccination 42 years) for covid-19 immunization. Medical history included covid-19 from Jan2021 to Jan2021. The patient did not administer additional vaccines on same date of the Pfizer Suspect. Family Medical History Relevant to adverse events (AEs), AEs following prior vaccinations and Prior Vaccinations (within 4 weeks) was reported as none. There were no concomitant medications. It was reported that, got 1st dose and on 27May2021 at 19:00. she has dizziness and Shortness of Breath feels like she was kind of holding her breath; feels breathing pressure. It feels like when she has a food allergy. Her throat was tight. She has a sore arm with swelling and warmth. Also reported as Sore Arm; Swollen; Warm/Hot; Painful. Patient stated, she was concerned, and she knows she has to report it, but most people have common things like arm pain and fever. Caller asking if this is a normal reaction of if she should be concerned, she has had Covid before and this feels worse. Caller states she was also concerned because her kids were getting their shots next week and she doesn't want them to feel like this. Caller states when she feels breathing pressure, she starts freaking out. Treatment: None. Caller states she opened the windows and laid back to try and open the airway. Caller states she doesn't know if she should go to the hospital or not. Caller states she was searching for information, but it didn't seem to be a common side effect. Caller states is feels like she is kind of holding her breath. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jan2021. The patient did not visit Emergency Room for AE. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, SARS-CoV-2 test, Throat tightness
Clinical narrative: dizziness; shortness of breath; her throat is tight; Sore Arm; Swollen; Warm/Hot; Painful; has a sore arm with swelling and warmth; has a sore arm with swelling and warmth; Sore Arm; Swollen; Warm/Hot; Painful; This is a spontaneous report from a contactable consumer reporting for herself. A 42-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 27May2021 10:00 (Batch/Lot number was not reported) as single dose (age at vaccination 42 years) for covid-19 immunization. Medical history included covid-19 from Jan2021 to Jan2021. The patient did not administer additional vaccines on same date of the Pfizer Suspect. Family Medical History Relevant to adverse events (AEs), AEs following prior vaccinations and Prior Vaccinations (within 4 weeks) was reported as none. There were no concomitant medications. It was reported that, got 1st dose and on 27May2021 at 19:00. she has dizziness and Shortness of Breath feels like she was kind of holding her breath; feels breathing pressure. It feels like when she has a food allergy. Her throat was tight. She has a sore arm with swelling and warmth. Also reported as Sore Arm; Swollen; Warm/Hot; Painful. Patient stated, she was concerned, and she knows she has to report it, but most people have common things like arm pain and fever. Caller asking if this is a normal reaction of if she should be concerned, she has had Covid before and this feels worse. Caller states she was also concerned because her kids were getting their shots next week and she doesn't want them to feel like this. Caller states when she feels breathing pressure, she starts freaking out. Treatment: None. Caller states she opened the windows and laid back to try and open the airway. Caller states she doesn't know if she should go to the hospital or not. Caller states she was searching for information, but it didn't seem to be a common side effect. Caller states is feels like she is kind of holding her breath. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on Jan2021. The patient did not visit Emergency Room for AE. The outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.