chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Poor quality sleep
Clinical narrative: headache; chills; warm forehead; sore left arm; second shot on 21Apr2021; he has not been able to get good sleep; tiresome.; This is a spontaneous report from a contactable consumer (patient). A 58-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: ER8729), via an unspecified route of administration in Arm Left on 21Apr2021 as single dose (at the age of 58-year-old) for precautionary measures. Medical history included left eye surgery for cataracts on 20Apr2021 and cataracts, had for over a year. The patient's concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EW0158), on 09Apr2021 as single dose for precautionary measures and experienced Sore left arm. Reported that patient had second vaccine shot from Pfizer yesterday. Was on way to work and was tiresome. Stated that he has not been able to get good sleep. Stated that he woke up at 3am with a headache and warm forehead. On 28Apr2021, the patient had chills. Stated that he had no effects from first vaccine but a left sore arm. Stated that his left arm is sore from the second one. Later clarified as Pfizer Covid 19. Stated that he had cataracts before the vaccines. Stated that when he picks something up, strains or moves his left arm that its sore. Stated that the first time he had a sore left arm that it went away in 4-5 days. Stated that he did not take Ourezel and Besivence today. Started using Ourezel and Besivence on 18 Apr or 19 Apr. The outcome of events headache, chills, warm forehead, sore left arm was not recovered, and for other events it was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: She was positive to Covid-19; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date: not reported), via an unspecified route of administration on 27Apr2021 as a dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, the caller called to say that received the vaccine last Tuesday on 27Apr2021 and on the same day, she got the PCR test. She was positive to Covid-19. She wanted to know whether she could proceed to get her second dose on 18May2021 or does she need to wait for 90 days. On 27Apr2021, the patient underwent lab tests and procedures which included PCR test, resulted as positive. The outcome of the event was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive for Covid; This is a spontaneous report from a Pfizer-sponsored program. Two contactable consumers reported for a 30-year-old male patient (boss) that he received BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration on 21Apr2021 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and patient's concomitant medications were not reported. The reporter was reporting for her boss who was in other country currently. Stated he received his first dose of the Pfizer covid vaccine on 21Apr2021 and he was tested positive for Covid on 27Apr2021 and wanted to know if she can take his second dose as scheduled or he needs to wait. No patient identifiers were provided but the reporter had firsthand knowledge of the patient and was reporting on a specific patient. The reporter was calling on behalf of Boss who received first vaccine 21Apr2021, was later diagnosed with COVID-19, asked if we can provide any medical advice in regard to receiving second dose. Transferred to vaccine. The patient underwent lab test which included COVID (COVID-19 virus test): positive on 27Apr2021. The outcome of the event was unknown.    No follow up attempts are possible. Information about lot/batch number cannot be requested.
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Dysgeusia
Clinical narrative: loss of taste /lost all taste; metallic taste in mouth/metal taste; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer reported that a male patient of an unspecified age received bnt162b2 (PFIZER COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8736), dose 1 via an unspecified route of administration on 28Apr2021 as 1ST DOSE, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 28Apr2021 patient experienced loss of taste /lost all taste, metallic taste in mouth/metal taste. (Withheld) received Pfizer Covid-19 vaccine first dose on 28Apr2021 and experienced side effects but he doesn't want to tell what kind of side effects. (Withheld) disconnected from the call and created a manual AE form. Caller has questions about side effects he is experiencing such as loss of taste and a metallic taste in mouth. He was speaking to someone prior to me, but call got disconnected. Declined isi. faxed ae. Cold transferred. Patient called about the Pfizer COVID Vaccine and states he has a question about the side effects of the vaccine; states 5 minutes after he had the 1st dose of the Pfizer COVID Vaccine he had a really strong metal taste and that is all he could taste and then he lost all taste and the taste progressively is going away; asks should he get a covid test and states he asked his HCP and the HCP has not yet called him back yet. Caller asked how long the report would take and declined to complete the report and requested transfer to and states if he has time after he speaks with he may do the report then. PC filed. Full report details not obtained due to caller declined to complete report; caller was provided the contact information for option #3; caller was placed on hold; due to larger than normal call volumes for, the caller agreed to be placed into the queue for the next available agent. Is there a Product Complaint: Yes. The outcome for the events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular
Clinical narrative: She has missed her menstrual cycle this month; Has not got period; This is a spontaneous report from a contactable consumer (patient). A 25-year-old Non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EW0 or O 173), dose 2 via an unspecified route of administration, administered in Arm Left on 29Apr2021 16:45 as 2ND DOSE, SINGLE for covid-19 immunisation (at the age of 25-years). The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. The patient previously took BNT162B2 on 07Apr2021 for Covid-19 Immunization, Vaccine Lot Number: first dose: it says EW then either 0 or O then 162, expiry unknown. Time the Vaccination was Given:16:30. Anatomical Location of Administration of Pfizer vaccine considered as suspect: first dose: thinks right arm. No prior vaccinations within 4 weeks and adverse events following prior vaccinations. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. On Apr2021 patient experienced she has missed her menstrual cycle this month, has not got period. Patient has received both the Pfizer Covid vaccine shots is reporting that she has missed her menstrual cycle this month and wants to know if vaccine affects the female cycle. Patient took both doses and by end of Apr2021 both at 16:30 to 16:45, and is calling bc she doesn't know if normal, she has not got period, she is 100% not pregnant, always gets on time, wonder is COVID vaccine has something related. Her period should have come on 01May2021, and she is wondering if the vaccine affects menstrual cycles or female health. The patient did not visited emergency room and physician office. The outcome for the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Eyelid infection, Pain in extremity, Underdose
Clinical narrative: knee; increased pain to her knees, hands (mostly the thumbs); Increased pain to her knees, hands (mostly the thumbs), and back; holding her xeljanz for about two weeks in total; eyelid infection; This is a spontaneous report from a Caremark Xeljanz C&P Program. A 63-year female consumer (patient) received Bnt162b2 (BNT162B2; Formulation: Solution for injection), via unknown route of administration, as Unknown SINGLE DOSE for COVID-19 immunization. Product use error. Patient reported holding her xeljanz for about two weeks in total for her covid vaccine (1 week before each injection). she reported while off her xeljanz having increased pain to her knees, hands (mostly the thumbs), and back. since she got back on her xeljanz, her pain is still present but has decreased to a tolerable level. patient also reported back in november, 2020 being hospitalized for 2-3 days because of a kidney stone. she was not sure if she was on xeljanz at the time and unsure if her rheumatologist was aware of the hospitalization. she also reported currently fighting an eyelid infection which she is being prescribed 3 months of doxycycline. rheumatologist is aware and wants her to continue with her xeljanz. no additional information provided.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Menstrual disorder, Pain, Platelet count increased, SARS-CoV-2 antibody test
Clinical narrative: Since 2nd shot I haven't had my menstrual cycle. Pre vaccine had it every month; My platelets has increased quite a bit since my 2nd shot. I normally have high platelets but they increased a lot; Chills; achiness; This is a spontaneous report from a contactable consumer (patient). A 47-years non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN5318 and expiry date: unknown), dose 2 via an unspecified route of administration, administered in Arm Left on 16Feb2021 11:30 as DOSE 2, SINGLE for covid-19 immunisation (at the age of 47-years). Medical history included essential thrombocythaemia. List of any other medications the patient received within 2 weeks of vaccination: Baby aspirin stopped 4 days prior to both shots. The patient was not pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received 1 dose of bnt162b2 on 26Jan2021 (lot number: EL3302, Anatomical Location: Arm Left). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. The patient experienced Since 2nd shot the patient haven't had my menstrual cycle. Pre vaccine had it every month. The patient platelets has increased quite a bit since the 2nd shot. The patient normally have high platelets but they increased a lot. 14 hrs after 2nd shot had chills and achiness for about a day. The event resulted in doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures which included sars-cov-2 antibody test: negative on an unknown date (Nasal Swab)(Get tested weekly (Tuesdays) as I'm a caregiver for my mom in a nursing home). Outcome of the events Since 2nd shot I haven't had my menstrual cycle. Pre vaccine had it every month and My platelets has increased quite a bit since my 2nd shot. I normally have high platelets but they increased a lot was Not recovered, Chills and achiness was Recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Menstruation irregular
Clinical narrative: COVID vax both doses taken. No periods anymore; This is a spontaneous report from a contactable consumer (patient). 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 a DOSE 2, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medications included oral contraceptives (unspecified) from an unspecified date and unknown if was ongoing. Patient previously received 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 a DOSE 1, SINGLE for covid-19 immunisation. The patient reported that, she experienced covid vax both doses taken and no periods anymore (menstruation irregular) on an unspecified date. She reported that, she was on oral contraceptives, so there should be no reason periods are not regular. Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Both doses of Pfizer COVID vaccine. On IUD no periods prior after vax, period back; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), 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 medication was not reported. The patient previously took dose 1 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 1 via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient experienced both doses of pfizer covid vaccine. on IUD (Intrauterine device) no periods prior after vax, period back on an unspecified date (Patient on IUD - not normal to have any menstrual bleeding) (Event took place after use of product). Outcome of the event was unknown.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested positive; This is a spontaneous report from a contactable consumer via Pfizer-sponsored program. A female patient of an unspecified age received first dose of 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 27Apr2021, as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 09May2021, patient was tested positive. Patient was schedule for the second dose of the vaccine on 18May2021. Patient wanted to know if she needs to go to the facility on that schedule. The outcome of the event of tested positive was unknown.  No follow-up attempts were needed. Information about lot/batch number could not be required. No further information was expected.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: tested COVID-19 positive; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A male patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- unknown) via an unspecified route of administration on 28Apr2021 as dose 1 single for COVID-19 immunization. Medical history and concomitant medications were not reported. Patient stated that he received the 1st dose of COVID-19 vaccine last 28Apr2021. but tested COVID-19 positive today, 10May2021. He had his 2nd dose scheduled on 19May (exactly 21 days apart) but requesting that to be moved due to his current situation. The patient underwent lab tests and procedures which included COVID-19: positive on 10May2021. The outcome of the event was unknown.  No follow-up attempts are possible. Information about lot/ batch no cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Ear pain, Headache, Pain
Clinical narrative: chills; headache; ear pain; body pain; This is a spontaneous report from a contactable consumer. A 54-year-old (non-pregnant) female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number and Expiration date was not reported) via unspecified route, administered in left arm on 10May2021 13:30 (at the age of 54-year-old) dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. No other vaccines taken in four weeks. Patient was not positive for covid prior vaccination and not tested post vaccination. No known allergies. On 11May2021, after the vaccination at 12:00 am, the patient experienced chills, headache, ear pain and body pain. No treatments were given. The events assessed as non-serious. The outcome of the events was unknown.  No follow-up attempts possible. No further information expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Underdose
Clinical narrative: First started to do it by numbing her and keeping her awake but her blood pressure went up to high; she states that dose in the syringe was "less than half the syringe full; This is a spontaneous report from a contactable 63-year-old female consumer (patient herself). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration, administered in left arm on 31Mar2021 (age at vaccination: 63) as dose 1, single for Covid-19 immunisation. Patient's medical history included a new Pacemaker put in on 14Apr2021 which was originally attempted to be placed with local anesthesia only, however, due to elevated blood pressure they placed it under light sedation, and ongoing kidney failure which started years ago on an unspecified date. Concomitant medications were none. When patient received her first dose by the Pharmacist, she stated that dose in the syringe was less than half the syringe full and then when she went back to receive the second dose she states that it was given to her by "the clerk" instead of a Pharmacist because the Pharmacist was not available that day. On 14Apr2021, she got new pacemaker put in, was put under anesthesia, and first started to do it by numbing her and keeping her awake but her blood pressure went up to high and so they lightly sedated her. The outcome of the events was unknown.  Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Vaccination site pain
Clinical narrative: has migraine and arm pain; has migraine and arm pain; This is a spontaneous report received from Pfizer sponsored program. A contactable consumer reported for female patient.  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot number: unknown), via an unspecified route of administration on 16May2021 as dose 1, single for COVID-19 immunization. No medical and concomitant medication history were reported. The patient experienced has migraine and arm pain. Wanted to know if patient can take Tylenol and also wanted to know if tylenol can affect the effectiveness of the vaccine. Outcome for the events was unknown.  Information on the Lot/Batch number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Feeling cold, Nausea, Peripheral swelling
Clinical narrative: Her feet feels like they are swollen; Dizziness; Nausesation; weird feeling from her knees down. It is like a coldness, it feels like she has wet socks on. She feels it down to her ankles; weird feeling from her knees down. It is like a coldness, it feels like she has wet socks on. She feels it down to her ankles; This is a spontaneous report from a contactable consumer. A 57-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot Number: EW0173; Expiration Date: Aug2021), dose 1 via an unspecified route of administration, administered in Deltoid Right on 05May2021 around 2'clock or 3'clock  (57 years age at the time of vaccination) as dose 1, 0.3 mL single for COVID-19 immunisation at Other- Stadium. Medical history included ongoing Pseudo Tumor (Has a VP shut for this), Kewari-1 (Commented this is a congenital birth defect), ongoing Renal dysplasia (Commented she has a stent in her kidney for this), ongoing all her valves are leaking, Tethered spinal cord (Had surgery for this years ago). Concomitant medications included blood pressure pills and a water pill, but no additional details provided. Patient reported that after first dose patient has had a weird feeling from her knees down. It is like a coldness, it feels like patient has wet socks on. Patient felt it down to her ankles. Patient was wondering if patient should get the second dose on 26May2021. Weird Feeling from knees down: It started that night on 05May2021. Patient was having issues with her shoes. Patient feet felt like they are swollen. Patient mentioned she does takes a water pill and has a VP Shunt. Her shoes feel tight on her. It is like Patient was retaining water. Patient was having swollen ankles and her feet were swollen. When probed for outcome and if event was still ongoing patient stated it was coming and going. Patient also later added Patient was having dizziness. It was periodically. Clarified it started the next day, 06May2021 . When probed for outcome patient sated it was like patient gets period of it. It was like a little vertigo. It comes and goes. Patient later clarified and confirmed outcome as it was getting better. Nauseation started the following day, on 06May2021. Patient initially stated it was pretty much going away. Later clarified and confirmed it has gone away. Patient had a little bit yesterday, but now Patient has recovered completely. The outcome of event Dizziness was recovering, for Nausesation was recovered on 16May2021 and for all rest events was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swelling in her lymph nodes / swollen lymph nodes; This is a spontaneous report from a contactable consumer or other non-hcp (patient).  A 70-years-old female patient 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 on 16Feb2021 (at the time of vaccination 70-years-old), as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced swelling in her lymph nodes/ swollen lymph nodes. It was reported that the caller got the first dose of the vaccine on 16Feb2021 and noticed swelling in her lymph nodes after the first dose but got the second dose 3 weeks later and is still having this swelling. She stated she talked to the doctor when it didn't go away for a month and he said give it a week or two. After that he said to send pictures and said give it another month but now it has been 3 months. She stated that everyone else she talked to that experienced this had it resolve in a couple weeks. She stated this is not comfortable. She asked how long is swollen lymph nodes supposed to last. Caller reports that she got her first dose of the Pfizer COVID Shot on 16Feb2021, and either that night or the next morning, the lymph nodes under her left arm were swollen. Caller thought they would just go away and she can't remember if it started on just the left side or on both sides, but anyway, three weeks after that. Caller states that the lymph nodes have not gone down as of now. The outcome of the event was unknown.  Additional information has been requested. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021564906 Same reporter/ drug/ event for different patients.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Did get a sore arm with her 1st dose; This is a spontaneous report from a contactable consumer (patient). A 44-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0158) via an unspecified route of administration in left arm on 07Apr2021 at 14:00 (at the age of 44-year-old) as single dose for COVID-19 immunization. Medical history of the patient was not reported. Concomitant medication included multivitamins [besides a multivitamin patient does not take anything on a regular basis and sees the HCP once a year; states she does not get sick often and was pretty healthy, eats well, takes vitamins and has an occasional glass of wine]. Patient previously received flu vaccine for immunization and has soreness in her arm. On an unspecified date in 2021, the patient experienced a sore arm with her 1st dose, the arm soreness was for a couple of days or so and was gone. It was reported that she has no name of the flu vaccine she had a sore arm with and no lot number, expiry date or NDC to provide and states the flu shot tends to cause soreness the same day and then she is fine and the Pfizer COVID19 1st dose she was sore a couple of days but it did not prohibit her from doing anything and was just noticeable. AE's does not require a visit to: Emergency Room, Physician Office. No Prior Vaccinations (within 4 weeks) administered. Outcome of the event was resolved on an unspecified date in 2021.  Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Fatigue, Headache, Menstruation irregular, Skin disorder
Clinical narrative: started seeing spots on a part of body after about a month; Early/ irregular periods started after the vaccination,; change in body shape; abdominal pain; headache; fatigue; This is a spontaneous report from a contactable consumer. This 38-years old non-pregnant female consumer (patient) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8731, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date in Apr2021 (at the age of 38-year-old) as dose 2, single for COVID-19 immunization, at pharmacy or drug store. The patient medical history was not reported. The concomitant medication included unspecified multi vitamin (only once in a while). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19, prior to vaccination. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EP6955, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date as single dose for COVID-19 immunization. It was reported that, on an unspecified date in 2021, the patient experienced early/ irregular periods started after the vaccination, abdominal pain n change in body shape, headache, fatigue, started seeing spots on a part of body after about a month (on an unspecified date in May2021). The device date was reported as 18May2021. The outcome of the events was reported as not resolved.  Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Weight fluctuation
Clinical narrative: started seeing spots on a part of body after about a month; Early/ irregular periods started after the vaccination,; change in body shape; abdominal pain; headache; fatigue; This is a spontaneous report from a contactable consumer. This 38-years old non-pregnant female consumer (patient) reported for herself that she received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: ER8731, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date in Apr2021 (at the age of 38-year-old) as dose 2, single for COVID-19 immunization, at pharmacy or drug store. The patient medical history was not reported. The concomitant medication included unspecified multi vitamin (only once in a while). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19, prior to vaccination. Previously the patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EP6955, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on an unspecified date as single dose for COVID-19 immunization. It was reported that, on an unspecified date in 2021, the patient experienced early/ irregular periods started after the vaccination, abdominal pain n change in body shape, headache, fatigue, started seeing spots on a part of body after about a month (on an unspecified date in May2021). The device date was reported as 18May2021. The outcome of the events was reported as not resolved.  Follow-Up (05Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Limb deformity, Pain, Product dose omission issue
Clinical narrative: No second dose of the Pfizer vaccine for COVID-19 received at 3 weeks after the first dose.; pains; couldn't lift her arms; extreme lethargy; body aches/tremendously achy; This is a spontaneous report from a contactable consumer or other non hcp. A 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot number was not reported) via an unspecified route of administration, administered in Arm Left on 03Feb2021 at 16:00 (about 4:00 in the afternoon) as DOSE 1, SINGLE for covid-19 immunisation. She has not taken her second dose yet and she wants to know if it is ok to take it now, 3.5 months after the first dose. caller says her mother was not sick at the time of vaccination, no allergies and no surgeries. She is as healthy as a horse. Medical history included ongoing rheumatoid arthritis probably about 10 years. Concomitant medications included methotrexate taken for rheumatoid arthritis, start and stop date were not reported; has been taking this a long time, like 10 years. She got the first COVID shot and the side effects she suffered they believe was due to the fact that she was on Methotrexate. She was lethargic and achy for about 10 days after she got the shot. She says they went to her doctor and rheumatologist and they heard of 2 other patients on methotrexate to treat rheumatoid arthritis that have experienced side effects. She got the first shot back in Feb2021 so can she go back and get the second shot as long as she's off the methotrexate before she goes. The patient experienced no second dose of the pfizer vaccine for covid-19 received at 3 weeks after the first dose, On 04Feb2021, extreme lethargy on 04Feb2021, body aches/tremendously achy (pain), pains, couldn't lift her arms (limb deformity) (non-serious) on an unspecified date. Her MD stated he felt it was because she was on Methotrexate and he advised her to stop taking this medication before resuming the vaccine series. She says they were going to go back to get the second shot, but her mother did not want the second shot because of the side effects. The caller says her mother didn't tell her about the side effects at first. She says they lasted 10 days, later confirmed it ended 13Feb2021. All the events started at the same time: first thing in the morning the next day. The outcome of the event (lethargy, pain) was recovered on 13Feb2021 and remaining events were unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pain
Clinical narrative: shingles; She says that the pain was unbearable; This is a spontaneous report from a contactable consumer. This 47-year-old female consumer reported for herself that she received bnt162b2 (BNT162B2, Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 30Apr2021 10:30 as DOSE 1, SINGLE for covid-19 immunisation (age at time of vaccination 47 years). Medical history included blood cholesterol abnormal (Caller says this was diagnosed about a year ago), hypertension (Caller says this was diagnosed about two years ago), Prediabetes (Caller says this was diagnosed about a year ago) Caller says that she is prediabetic about a year ago told about this month tests again came out the same way. No PQC Present. She did not get any other vaccines the same day as the Pfizer COVID-19 vaccine or in the four weeks beforehand. She says that the only medications she takes are cholesterol and high blood pressure, which she was taking previously. On an unspecified date in May2021 the patient experienced shingles, on 2021 she says that the pain was unbearable. She has an appointment to get the second dose on Friday, she don't know if she should receive it or if she should wait. Therapeutic measures were taken as a result of events. She says that for her shingles treatment she is taking pills now, caller provides no further information about the pills. The outcome for event shingles was unknown for pain it was recovering.   Information about lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Dizziness, Headache, Pyrexia, Rash
Clinical narrative: Rash; Swelling on my collar bone; High Fever; Dizziness; Headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0177, Expiration Date was not reported), via an unspecified route of administration, administered in Deltoid Left on 16May2021 (at the age of 60-year-old) as single dose for COVID-19 immunisation. Anatomical site of vaccination was left shoulder. The patient medical history included thyroid. Concomitant medications included levothyroxine (LEVOTHYROXINE); acetylsalicylic acid (ASPIRIN (E.C.), 81mg); metoprolol (METOPROLOL). The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. It was reported that, patient stated that she was calling because she had her second shot on Sunday, she had a reaction to the shot which was normal, which was the high fever and dizziness and a headache but today she had rash and it was swelling on her collar bone. She did not know if that was another reaction to that, she knew the rash was normal, but she did not know about the swelling on her collarbone. Patient was asking was that okay or there was something she should do. Consumer stated, she just was wondering about the swelling on the collarbone was that something she need to worry about, or should she just take some like Benadryl or something for allergic reactions to it or what she should do. Events still experiencing includes the rashes and swelling on the collar bone. Consumer stated, just today, she got her blood work done. She did not know it was just her thyroid check and her cholesterol check. The patient underwent lab tests and procedures which included blood test: unknown on 18May2021. Consumer stated, "Rosuvastatin" (Not appropriately clarified hence, not captured in tab). No treatment received. The outcome of the event swelling on her collar bone was not resolved and unknown for other events.  Information on lot/batch number was available. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Rash; Swelling on my collar bone; High Fever; Dizziness; Headache; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number: EW0177, Expiration Date was not reported), via an unspecified route of administration, administered in Deltoid Left on 16May2021 (at the age of 60-year-old) as single dose for COVID-19 immunisation. Anatomical site of vaccination was left shoulder. The patient medical history included thyroid. Concomitant medications included levothyroxine (LEVOTHYROXINE); acetylsalicylic acid (ASPIRIN (E.C.), 81mg); metoprolol (METOPROLOL). The patient historical vaccine included first dose of BNT162B2 for COVID-19 immunization. It was reported that, patient stated that she was calling because she had her second shot on Sunday, she had a reaction to the shot which was normal, which was the high fever and dizziness and a headache but today she had rash and it was swelling on her collar bone. She did not know if that was another reaction to that, she knew the rash was normal, but she did not know about the swelling on her collarbone. Patient was asking was that okay or there was something she should do. Consumer stated, she just was wondering about the swelling on the collarbone was that something she need to worry about, or should she just take some like Benadryl or something for allergic reactions to it or what she should do. Events still experiencing includes the rashes and swelling on the collar bone. Consumer stated, just today, she got her blood work done. She did not know it was just her thyroid check and her cholesterol check. The patient underwent lab tests and procedures which included blood test: unknown on 18May2021. Consumer stated, "Rosuvastatin" (Not appropriately clarified hence, not captured in tab). No treatment received. The outcome of the event swelling on her collar bone was not resolved and unknown for other events.  Information on lot/batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hypoaesthesia
Clinical narrative: numbness; headache; dizziness; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA 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 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced numbness, headache and dizziness on an unspecified date. It was reported that, The caller was a pharmacist who reported an adverse event regarding her sister. The pharmacist stated that her sister received the Pfizer COVID-19 vaccine and then developed symptoms similar to that of the pharmacist when she received the Moderna COVID-19 vaccine. The pharmacist stated that she personally developed numbness in her body, a headache, and dizziness following the Moderna COVID-19 vaccine and that her sister had developed the same symptoms following the Pfizer COVID-19 vaccine. Adverse Event regarding pharmacist's Moderna COVID-19 side effects already reported. Consent obtained for Safety Team follow up. The outcome of the events were unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Accident
Clinical narrative: got into an accident after the 1st dose; This is a spontaneous report from a contactable consumer or other non-HCP (Patient) via Pfizer sponsored Program. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 03May2021 (Batch/Lot number was not reported) as dose 1, single for covid-19 immunisation. The second dose was scheduled on 24May2021. The patient medical history and concomitant medications were not reported. On an unspecified date, got into an accident after the 1st dose. The patient was having some transportation issue going to the vaccination facility. He wanted to know if getting into an accident and being wounded after the first dose, will that have any effect with the vaccine. Outcome of the event was unknown.  Information about lot/batch number cannot be obtained. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Malaise
Clinical narrative: I got very severe pain in my right knee; after that very severe pain in my right knee and my left shoulder; the pain in the right knee was so bad; I couldn't walk like 4 days; I also had the chills for number of days; the pain in the left shoulder, very bad pain; not feeling well; This is a spontaneous report from a contactable consumer (patient) or other non HCP.   A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: unknown, Expiration date: unknown) dose 1 via an unspecified route of administration in Arm Right on 14May2021 (at the age of 69 years old) as dose 1 single for COVID-19 immunisation. Medical history included arthritis from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. On an unspecified date the patient experienced as, he got very severe pain in my right knee; after that very severe pain in my right knee and my left shoulder; the pain in the right knee was so bad; he couldn't walk like 4 days, he also had the chills for number of days, the pain in the left shoulder, very bad pain, not feeling well. Consumer stated that, he had  first Pfizer Covid-19 shot on 14May and for the first two days, he didn't have any symptoms but then he started, he got very severe pain in his right knee. After that very severe pain in his right knee and left shoulder. he got the vaccination on right shoulder but the pain in the right knee was so bad. he couldn't walk for like 4 days and its better now but he have and he have arthritis it normally gets pain like that chills the vaccine. he have arthritis but he don't get normally get pain like that, its better now. he also had the chills for number of days. The pain in the left shoulder, very bad pain. he stated from 3rd day he started experiencing sever right knee pain ( lasted 5 days) and unable to walk, left shoulder pain (received vaccine in the right arm) lasted about 2 days, chills and not feeling well. he stated he has ostomy and gets dehydrate easily. He stated he scared to deat to take second dose. patient received treatment some pain medication. Outcome of the event knee pain was recovered, while outcome of other events was unknown.  Information about lot/batch number has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Hypoaesthesia, Mobility decreased, Myalgia, Pain in extremity
Clinical narrative: Muscle pain, joints pain in my hands and toes; Hands are like numb and they are getting like lazy and I can't touch paper; like shaking together; Muscle pain, joints pain in my hands and toes; Muscle pain, joints pain in my hands and toes; Hands are like numb and they are getting like lazy and I can't touch paper; Toes are not moving like they use to; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. This 30-year-old female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172 and Expiry date: Aug2021), via an unspecified route of administration, administered in Left arm on 26Apr2021 (at the age of 32-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported.The patient's concomitant medications were not reported. On an unspecified date, the patient stated, "I called because I had side effects from this vaccine. Now I am having side effects that I never had before and the side effect that I had muscle pain, joints pain in my hands and toes, my hands are like numb and they were getting like lazy and I could not touch paper, now its my toes, my toe I am not moving, I got muscle pain and numbness and they were like shaking together, toes were not moving like they use to and I had muscle pain in my arm that I got the shot on 26th April, I had minor complications. Consumer further stated that I  still in pain right now. The patient underwent to emergency room and they gave Ibuprofen 600 mg tablet. The outcome of event was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sensitive skin, Tremor
Clinical narrative: Muscle pain, joints pain in my hands and toes; Hands are like numb and they are getting like lazy and I can't touch paper; like shaking together; Muscle pain, joints pain in my hands and toes; Muscle pain, joints pain in my hands and toes; Hands are like numb and they are getting like lazy and I can't touch paper; Toes are not moving like they use to; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. This 30-year-old female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172 and Expiry date: Aug2021), via an unspecified route of administration, administered in Left arm on 26Apr2021 (at the age of 32-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported.The patient's concomitant medications were not reported. On an unspecified date, the patient stated, "I called because I had side effects from this vaccine. Now I am having side effects that I never had before and the side effect that I had muscle pain, joints pain in my hands and toes, my hands are like numb and they were getting like lazy and I could not touch paper, now its my toes, my toe I am not moving, I got muscle pain and numbness and they were like shaking together, toes were not moving like they use to and I had muscle pain in my arm that I got the shot on 26th April, I had minor complications. Consumer further stated that I  still in pain right now. The patient underwent to emergency room and they gave Ibuprofen 600 mg tablet. The outcome of event was unknown.
Age: 30.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Autoimmune disorder, Computerised tomogram, Constipation, Depressed mood
Clinical narrative: Muscle pain, joints pain in my hands and toes; Hands are like numb and they are getting like lazy and I can't touch paper; like shaking together; Muscle pain, joints pain in my hands and toes; Muscle pain, joints pain in my hands and toes; Hands are like numb and they are getting like lazy and I can't touch paper; Toes are not moving like they use to; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. This 30-year-old female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0172 and Expiry date: Aug2021), via an unspecified route of administration, administered in Left arm on 26Apr2021 (at the age of 32-years-old) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization. The patient medical history was not reported.The patient's concomitant medications were not reported. On an unspecified date, the patient stated, "I called because I had side effects from this vaccine. Now I am having side effects that I never had before and the side effect that I had muscle pain, joints pain in my hands and toes, my hands are like numb and they were getting like lazy and I could not touch paper, now its my toes, my toe I am not moving, I got muscle pain and numbness and they were like shaking together, toes were not moving like they use to and I had muscle pain in my arm that I got the shot on 26th April, I had minor complications. Consumer further stated that I  still in pain right now. The patient underwent to emergency room and they gave Ibuprofen 600 mg tablet. The outcome of event was unknown.