chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Rash, Skin burning sensation, Urticaria
Clinical narrative: on her lower back four more little red welts; it doesn't burn, though once in a while it does; she is worried about the rash; This is a spontaneous report from a contactable consumer or other non hcp (patient self reported).  A 74-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Batch/Lot Number: EM9810; Expiration Date: Jun2021), via an unspecified route of administration in Arm Left on 12Feb2021 (11:00) as a single dose for COVID-19 immunization. The patient medical history was not reported. The patient previously received the first dose of BNT162b2(Batch/Lot Number: ENS318, Expiration Date: May2021) in her left arm on 22Jan2021 (about 11:00AM) for COVID-19 immunisation and experienced patch on her back and red welt the size of a quarter. Concomitant medications included: reported stated that says that she was only on one medication and takes magnesium calcium, curcuma longa- turmeric; vitamin c- ascorbic acid, ergocalciferol- Vit D, the basics, taken for an unspecified indication, start and stop date were not reported. No further information provided about her medication or vitamins.  The reporter says after her second shot on 23Jan2021, she developed on her lower back four more little red welts, and she doesn't know if they could be from the vaccine. Reporter says that her welts have stayed about the same, she hasn't gotten any more, it is the same basic ones. She says that the first one looks like it is going away, and the others are smaller that appeared after the second dose, they are the size of a dime. She says she was putting Aloe Vera Clear Gel on it since it is unscented and has no smell or nothing. She says that this product is an old one, but is still clear and didn't turn colors or anything. Aloe Vera Clear Gel UPC number. LOT/EXP: Unknown, caller says this product doesn't have this information to provide. She says the bottle says healing therapy, apply liberally to sunburn or irritated skin as needed. Reporter stated that she was concerned because her sister looked at the welts and asked her if she thought she got shingles from it, and she was like no, it doesn't burn, though once in a while it does, and sometimes it doesn't itch, it is not something that bothers her, it's just there. No Investigation Assessment was reported. Outcome of the reported events were unknown.   Follow-up attempts are completed. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a non-contactable consumer.  A 27-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 07Feb2021 at single dose for COVID-19 immunization at the age of 27-year-old. Medical history and concomitant medications were unknown. On 08Feb2021, the patient experienced soreness at injection site; no treatment given for the event. The patient recovered from the event. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Nausea, Paraesthesia, Peripheral coldness, Urticaria
Clinical narrative: This is a spontaneous report from a contactable other HCP (Pfizer colleague). This other HCP (patient) reported the following: A 35-years-old female patient received the first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration in left arm on 22Feb2021 at 03:30 PM as a single dose for COVID-19 immunization. The patient medical history allergies to bee/wasp and to medication including Naprosyn/Naproxen. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient stated that on 22Feb2021, within 30 minutes after vaccination, she was aware of hives and within 1 hour after vaccination, her had epidermis had a burning sensation all over body. The patient reported that an hour after her COVID-19 injection, she began to experience itching all over her body from head to toe, hives, a burning sensation under her skin, nausea, and a tingling sensation in her extremities. Also, they became cold to the touch. Also, the pain at the injection site was more severe the 2nd day than the 1st. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events including Benadryl (antihistamine). The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable other HCP (Pfizer colleague). This other HCP (patient) reported the following: A 35-years-old female patient received the first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration in left arm on 22Feb2021 at 03:30 PM as a single dose for COVID-19 immunization. The patient medical history allergies to bee/wasp and to medication including Naprosyn/Naproxen. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient had not been tested for COVID-19. Concomitant medications were not reported. The patient stated that on 22Feb2021, within 30 minutes after vaccination, she was aware of hives and within 1 hour after vaccination, her had epidermis had a burning sensation all over body. The patient reported that an hour after her COVID-19 injection, she began to experience itching all over her body from head to toe, hives, a burning sensation under her skin, nausea, and a tingling sensation in her extremities. Also, they became cold to the touch. Also, the pain at the injection site was more severe the 2nd day than the 1st. The events resulted in doctor or other healthcare professional office/clinic visit. The patient received treatment for the events including Benadryl (antihistamine). The outcome of the events was unknown. No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: Arm that received the vaccination became red, itchy and swollen on the injection site; Arm that received the vaccination became red, itchy and swollen on the injection site; Arm that received the vaccination became red, itchy and swollen on the injection site; This is a spontaneous report from a contactable consumer (patient).    A 47-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1, via an unspecified route of administration, administered in arm, on 18Feb2021, as single dose, for COVID-19 immunisation. The patient medical history was and concomitant medications were not reported. The patient stated that the arm that received the vaccination became red, itchy and swollen on the injection site. Due to the events, the patient went to the doctor and was given a steroid cream and diphenhydramine (BENADRYL).  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Eye swelling, Joint swelling, Urticaria
Clinical narrative: Hives all over my body; Swollen eyes; Swollen knees elbows; Chills; This is a spontaneous report from a contactable Other Health Professional. A 41-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9266, expiry date was not reported), dose 2 via an unspecified route of administration, administered in Arm Right on 22Feb2021 14:30, 2ND DOSE, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient had no allergies. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19, prior vaccination and since the vaccination. Historical vaccine includes BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264, expiry date was not reported), dose 1 via an unspecified route of administration, administered in Arm Right on 31Jan2021 13.00, Single for COVID-19 immunization. The patient experienced Hives all over my body, swollen eyes, swollen knees elbows, chills on 22Feb2021 14:30. Patient was treated with Dosepk 4 MG. Adverse events resulted in Emergency room/department or urgent care. The clinical outcome of the events were not recovered.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives on neck and stomach; This is a spontaneous report from a contactable consumer (Patient). A 24-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date: not reported), dose 1 via an unspecified route of administration, in Arm Left on 23Feb2021 at 16:30  as single for Covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient previously took benzalkonium chloride and experienced drug allergies. Patient was not diagnosed with COVID, prior vaccination. Patient has not been tested for COVID, post vaccination. Patient did not take other vaccine in four weeks and other medications in two weeks. On 23Feb2021 18:00, the patient had experienced hives on neck and stomach. Treatment medication was Benadryl. The outcome of event was unknown.  No follow-up attempts are possible. Information about the lot/batch number cannot be obtained. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain in extremity
Clinical narrative: Extreme tired; Chills; Arm pain; This is a spontaneous report from a contactable consumer (patient) . A 54-year-old male patient received the first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EN5318) via an unspecified route of administration in left arm on 01Feb2021 at 07:30 (at 54 years) at single dose for covid-19 immunisation. Medical history included kidney donor.No known allergy. There were no concomitant medications. On 01Feb2021 at 10:00 the patient was extreme tired and experienced chills and arm pain.No treatment given and patient recovered from the events in Feb2021.No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021201495 same patient, different drug/AE
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Two days after the shot I had a large bruise on my right leg. I don't remember bumping my leg.; This is a spontaneous report from a contactable consumer (patient).   A 50-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on 15Feb2021 10:00 (Lot Number: EL9266) (at the age of 50) as single dose for covid-19 immunisation. Medical history included high blood pressure. No known allergies. Concomitant medications included amlodipine, boron, calcium, cimicifuga racemosa extract, folic acid, glycine max extract, magnolia officinalis, nicotinic acid, pyridoxine hydrochloride, riboflavin, selenium, thiamine, tocopherol, vitamin b12 nos (ESTROVEN) taken. No other vaccine in four weeks. The patient experienced two days after the shot 'i had a large bruise on my right leg. i don't remember bumping my leg' on 17Feb2021 07:45. No treatment received. No covid prior vaccination. No covid tested post vaccination. The event outcome was unknown.    No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness (same side as injection)  to her cheek, jaw, and side of throat that resolved the same day; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), on 03Feb2021 (at the age of 75-years-old) at 1st dose, single for COVID-19 immunisation. Medical history and concomitant medications were not reported. On 03Feb2021, the patient experienced numbness (same side as injection) to her cheek, jaw, and side of throat that resolved the same day. The event was reported as non-serious. The patient was calling to ask if she should get the second dose. Her medical doctor (MD) was recommending that she not receive it. The patient had recovered from the event on 03Feb2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male consumer received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 21Feb2021 at single dose for COVID-19 immunisation at the age of 68-year-old. Medical history and concomitant medications were unknown. On 22Feb2021, the patient experienced fatigue. The patient did not recover from the event. No follow-up attempts are possible; information about lot/batch number cannot been obtained
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness and tingling in my face, it's around my chin; Numbness and tingling in my face, it's around my chin /I felt kind of weird but I definitely felt tingling; I felt kind of weird but I definitely felt tingling; This is a spontaneous report received from a contactable consumer (patient). A 61-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EL9264), on 03Feb2021 as 1st dose, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. Patient asking if she should get her second dose of Pfizer's COVID vaccine the day of the present report, 24Feb2021, if she experienced numbness and tingling in her face after the first dose on 03Feb2021. Patient asked if getting only the 1st shot protected her in any way. Patient also stated that she was supposed to get her second shot the day of the present report (24Feb2021) and when she had her first shot, she should had contacted when she had it but she didn't and at the time of this report she was like worried, but she had a lot of numbness and tingling in her face, it was around her chin and they did not know, her daughter was looking up and she said she did not think she should get the second shot which she mean she felt fine otherwise, she felt kind of weird but she definitely felt tingling she was almost going to get back in (clarification unknown) but she decided to go home but it was like 15 minutes after. In response to further probing, patient stated that she did not know if she should get the second shot that was why she was asking, should she get the second dose. The events were reported as non-serious. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: headache; This is a spontaneous report from a contactable consumer reporting for herself.  A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 23Feb2021 at single dose via an unspecified route of administration for COVID-19 immunization.  Relevant medical history and concomitant medications were not reported. The patient informed she received second dose of vaccine on 23Feb2021 and woke up with a headache. She was wondering if she can take Tylenol or Aleve. AT the time of the reporting event outcome was unknown.   Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Extreme lower back pain. Started approx 2 hours after injection. Haven't decided to go to Dr. about it. Not sure if from vaccine or coincidental. However I have no history of back issues/pain.; This is a spontaneous report from a contactable other healthcare professional (patient) who reported for herself.   A 46-year-old non-pregnant (at the time of vaccination) female patient received first dose ofBNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Batch/Lot Number: EN6202), via an unspecified route of administration, administered in left arm on 23Feb2021 at 13:45 (46-year-old at the time of vaccination) as single dose for covid-19 immunization. Patient medical history was none. Concomitant medications included sertraline and chlorphenamine maleate (CHLORPHENIRAMINE C). Patient had no known allergies. No other vaccinations within four weeks prior to the first administration date of the suspect vaccine. Patient had no Covid prior vaccination; Patient was not tested for Covid post vaccination. On 23Feb2021 at 15:45, the patient experienced extreme lower back pain that started approx. 2 hours after injection, and she has not decided to go to doctor about it as she was not sure if from vaccine or coincidental. However, she had no history of back issues/pain. Patient did not receive any treatment for event. The Outcome of the event was not recovered.  Follow-up attempts completed. No further information expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: body aches; chills; Low grade fever/low grade temp; Headache; she had like a little bubble in that shot area/a little swollen area; This is a spontaneous report from a contactable consumer (patient's husband).  A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EL9267), via an unknown route, on 23Feb2021 (at the age of 64-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided) administered on unknown date for COVID-19 immunisation. The patient did not have a relevant medical history and concomitant medications.  On 23Feb2021, the patient had body aches, chills, and low grade fever/low grade temp. Then, the patient developed headache. When she got the shot, she had like a little bubble in that shot area, he was not sure if that is common or not. He confirmed like a little swollen area. The patient took paracetamol (TYLENOL) that didn't work so she asked if could take acetylsalicylic acid (ASPIRIN). The patient was recovering from chills and had not recovered from headache. The outcome of the remaining events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: body aches; chills; Low grade fever/low grade temp; Headache; she had like a little bubble in that shot area/a little swollen area; This is a spontaneous report from a contactable consumer (patient's husband).  A 64-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number EL9267), via an unknown route, on 23Feb2021 (at the age of 64-year-old) at single dose for COVID-19 immunisation. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not provided) administered on unknown date for COVID-19 immunisation. The patient did not have a relevant medical history and concomitant medications.  On 23Feb2021, the patient had body aches, chills, and low grade fever/low grade temp. Then, the patient developed headache. When she got the shot, she had like a little bubble in that shot area, he was not sure if that is common or not. He confirmed like a little swollen area. The patient took paracetamol (TYLENOL) that didn't work so she asked if could take acetylsalicylic acid (ASPIRIN). The patient was recovering from chills and had not recovered from headache. The outcome of the remaining events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise
Clinical narrative: she felt ill; headache; This is a spontaneous report from a contactable consumer (patient), received via Pfizer. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 16Feb2021 (Batch/Lot number was not reported) as unknown, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient felt ill and had a headache on 23Feb2021. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash; itchy; This is a spontaneous report from a contactable consumer.  A 69-year-old male patient received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on 11Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.  Patient experienced rash on chest and back that was itchy and consulted his doctor in which they stated to put hydrocortisone cream on it. Patient stated that his doctor said to go ahead and get the second dose, but to let the vaccination provider know about the reaction and let them make the decision there.  The reported events were rash (non-serious) on Feb2021 with outcome of not recovered , itchy (non-serious) on Feb2021 with outcome of unknown.  Therapeutic measures were taken as a result of rash and  itchy.   No follow-up attempts are possible. Information about lot/batch cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Musculoskeletal discomfort
Clinical narrative: shoulder pain; shoulder discomfort/Developed discomfort in shoulder; bilateral knee pain/Right knee and left knee have been very painful when I bend it, when I change position; This is a spontaneous report from a contactable consumer or other non hcp.  A 66-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL9267 Expiration date: unknown), dose 1 via an unspecified route of administration on 17Feb2021 as1ST DOSE, SINGLE for covid-19 immunisation.  Medical history included high blood pressure, blood cholesterol increased, diabetes mellitus, knee arthroplasty, knee replacement in both knees. Concomitant medication included insulin (INSULIN) taken for diabetes mellitus, simvastatin (SIMVASTATIN) taken for unspecified indication, losartan (LOSARTAN) taken for unspecified indication and oxybutynin hydrochloride (OXYBUTYNIN CHLORIDE) taken for unspecified indication. The patient previously took tylenol and experienced drug ineffective. The patient experienced Musculoskeletal discomfort /Developed discomfort in shoulder, bilateral knee pain/Right knee and left knee have been very painful when I bend it, when I change position on an unspecified date in 2021 and shoulder pain on 17Feb2021. It was reported that the patient received first Pfizer Covid vaccine dose on 17Feb2021. She had since experienced shoulder discomfort and bilateral knee pain. She had a history of knee replacements in both knees - her right knee was replaced in Jan2021 and the left in 2020. and she also has a history of a knee replacement in both of those knees and she feels that it might be related to that somehow. The shoulder pain was later that afternoon on the 17th and she is not totally sure about knee pain. It was probably that day or the next day. She is still experiencing with the events in the knee and not in the shoulder. Consumer stated that the outcome has probably gotten worse. She has been icing it and taking Tylenol and neither one seems to do a whole lot. As long as she is holding her knees still, it's fine, it's when she bend it, when she change position. She stated that she was just hoping to get some information on how long this pain is going to last. The discomfort in shoulder was reported as worsened. Upon on 24Feb2021, it was reported that the patient do not just need to report a side effect with the Covid vaccine but she has a enquired about how long side effect generally last. She asks if there are some websites she can go to for that information or if she can get that from Pfizer. Patient also reported her Weight: 89.81 kg and height : 160 cm. NDC and UPC number was not provided. Outcome of the events were not recovered. Follow up (24Feb2021): This is a follow up spontaneous report from a contactable female consumer new information included suspect product detail, medical history, concomitant medication.  Follow up (24Feb2021): This is a follow up spontaneous report from a contactable consumer.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dizziness, Headache, Hypersensitivity, Hypoaesthesia
Clinical narrative: 1st dose of bnt162b2 on 03Feb2021/ 2nd dose on 18feb2021; Start Date/Time:18Feb2021 01:00 PM; Start Date/Time: 03Feb2021 12:45 PM; numbness came back stronger from head to toe; feel sizzy; not very well; severe allergy; severe allergy sneezing; headache; full body numbness; This is a spontaneous report from a contactable consumer (reporting for herself). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 13:00 (Batch/Lot number was not reported) as 2NDDOSE, SINGLE for covid-19 immunisation. Medical history included gall bladder removed, kidney stones and hysterectomy. concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 03Feb2021 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks. The patient not received other medication within 2 weeks. Prior to vaccination, the patient was not diagnosed with covid. Post vaccination, the patient not tested for covid. The patient was vaccinated with second short after 5 hours full body numbness occurred on 18Feb2021. By next morning it was gone. On 19Feb2021 then severe allergy sneexing and headach that I have never had before it took 3 antihistimines to settle it down some. On 20Feb2021 to 22Feb2021 feel sizzy at times and not very well. On 23Feb 2021 numbness came back stronger from head to toe. I am in emergency room now and they gave me steriods and are checking my blood. The events was assessed as serious (medically significant). Treatment was received for events. The outcome of the event body numbness was recovered and remaining all events were not recovered.  Information about lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Malaise, Off label use, Sneezing
Clinical narrative: 1st dose of bnt162b2 on 03Feb2021/ 2nd dose on 18feb2021; Start Date/Time:18Feb2021 01:00 PM; Start Date/Time: 03Feb2021 12:45 PM; numbness came back stronger from head to toe; feel sizzy; not very well; severe allergy; severe allergy sneezing; headache; full body numbness; This is a spontaneous report from a contactable consumer (reporting for herself). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in Arm Left on 18Feb2021 13:00 (Batch/Lot number was not reported) as 2NDDOSE, SINGLE for covid-19 immunisation. Medical history included gall bladder removed, kidney stones and hysterectomy. concomitant medications were not reported. The patient previously took first dose of bnt162b2 on 03Feb2021 for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks. The patient not received other medication within 2 weeks. Prior to vaccination, the patient was not diagnosed with covid. Post vaccination, the patient not tested for covid. The patient was vaccinated with second short after 5 hours full body numbness occurred on 18Feb2021. By next morning it was gone. On 19Feb2021 then severe allergy sneexing and headach that I have never had before it took 3 antihistimines to settle it down some. On 20Feb2021 to 22Feb2021 feel sizzy at times and not very well. On 23Feb 2021 numbness came back stronger from head to toe. I am in emergency room now and they gave me steriods and are checking my blood. The events was assessed as serious (medically significant). Treatment was received for events. The outcome of the event body numbness was recovered and remaining all events were not recovered.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Malaise, Pyrexia
Clinical narrative: She feels slightly feverish; not feeling well; tired; This is a spontaneous report from a contactable consumer reporting for herself  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on an unspecified date at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On an unspecified date patient reported she feels slightly feverish and not feeling well. She was not sure if she has COVID,  recorded  a temperature of  97F. Patient also mentioned that if she was over tired she always feels feverish. It was also mentioned that she was scheduled to have her 2nd dose of vaccination on 25Feb2021. At the time of the reporting event outcome was unknown.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Palpitations, Paraesthesia
Clinical narrative: heart palpitations; tingling in his arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as 1st dose, single for COVID-19 immunisation. Medical history included anxiety. The patient's concomitant medications were not reported.  The Thursday after receiving his first dose of the vaccine, on 11Feb2021, the patient started experiencing tingling in his arm and heart palpitations. He was seen in the Emergency Room and he had a full cardiac work up completed. He was cleared by cardiology and was given the diagnosis of heart palpitations. He has spoken with his HCP and Cardiologist about the safety of receiving the second dose of the Pfizer COVID-19 vaccine and if these palpitations could have been a result from receiving the first dose. Both of his doctors agree that he should proceed with receiving the second dose of the vaccine. The caller states that he was not sure if this event happened because of receiving the vaccine or because of anxiety. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Nausea, Pyrexia
Clinical narrative: chills; nausea; low grade fever (99-100 F); This is a spontaneous report from a non-contactable e consumer (patient).  A 42-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 2 via an unspecified route of administration, administered in Arm Right on 23Feb2021 09:30 (Batch/Lot Number: EL3247), age at vaccination of 42-years-old, as single dose, for covid-19 immunisation.  The patient medical history was not reported. The patient had no allergy. The patient was not pregnant and was not pregnant at the time of vaccination.There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient experienced chills, nausea, low grade fever (99-100F), all on 24Feb2021 at 11:00 AM. No treatments were given. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease
Clinical narrative: She currently reports a copd flareup; This is a spontaneous report from a contactable consumer reporting for herself.  A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 19Feb2021 at single dose via an unspecified route of administration for COVID-19 immunization. Relevant medical history included COPD. Concomitant medications included prednisone as needed for COPD for flareup. Patient informed she had been off prednisone for a month prior to the first dose of the vaccine. She currently reported a COPD flareup and was prescribed a dose of prednisone. Patient was also asking if the prednisone could have interference with effectiveness of vaccine.  At the time of the reporting events outcome was unknown.   No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia
Clinical narrative: sharp muscle and joint pain; sharp muscle and joint pain; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation.  The patient medical history was not reported. The patient's concomitant medications were not reported.   The patient experienced sharp muscle and joint pain after her first and second shot of the vaccine.  The patient experienced sharp muscle and joint pain (myalgia) (non-serious) on an unspecified date with outcome of unknown, sharp muscle and joint pain (arthralgia) (non-serious) on an unspecified date with outcome of unknown.     Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Vaccination site pain
Clinical narrative: diarrhea; dizziness; chills; pain at injection site; This is a spontaneous report from a contactable consumer. This 66-year-old female consumer (patient) reported for herself.  A 66-year-old non-pregnant female patient (not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number and Expiration date was unknown), via an unspecified route of administration in left arm, on 23Feb2021 at 09:00 Am (patient was 66-year-old at the time of vaccination) at a single dose for covid-19 immunization (at the age of 66 years). The patient's medical history included allergy to penicillin. The patient's concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. She did not receive any other medications in two weeks. Neither the patient had covid-19 prior to vaccination, nor tested for covid post vaccination. On 23Feb2021 at 06:00 Pm, the patient experienced pain at injection site, chills, dizziness, and diarrhoea. Patient did not receive any treatment for events. The outcome of events were recovering.  Information about Lot/Batch number has been requested. Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lethargy
Clinical narrative: lethargy; Tired; This is a spontaneous report from a non-contactable consumer. An 80-years-old male patient received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine via an unspecified route of administration on 28Jan2021 (Batch/Lot Number: EL9262) as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, about 2 to 3 days after vaccination, the patient experienced lethargy and tiredness which stayed for about 2 to 3 days. The events outcome was unknown at the time of the report.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tooth infection
Clinical narrative: he noticed that the infection came/tooth infection; This is a spontaneous report from a non-contactable consumer (patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 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 tooth infection from an unknown date to an unknown date (prescribed with antibiotics for it). The patient's concomitant medications were not reported. The patient noticed that the tooth infection came back on an unspecified date after 1st dose of BNT162B2 . Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This is a spontaneous report from a contactable consumer (caregiver) who reported on behalf of her father.  A 85-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration on 06Feb2021 at single dose for covid-19 immunisation  .  The patient medical history and concomitant medications were not reported. Patient received the first dose of the vaccine on 06Feb2021. 3 days after vaccination (Feb2021), he experienced "strong symptoms" including fever and muscle pain, he tested positive for COVID-19 in Feb2021. The second dose was scheduled for 27Feb2021. It was asked if patient should receive his second vaccination if he tested positive for COVID-19 after his first dose. The outcome was unknown.No follow-up attempts are possible, information about batch number cannot be obtained
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypersensitivity, Pain
Clinical narrative: aching; allergies; This is a spontaneous report from a contactable consumer.     A 73-years-old female patient received first bnt162b2 (BNT162B2), via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not reported) as single dose for covid-19 immunisation. Patient scheduled on Saturday 27Feb2021 for second dose. Medical history included arthritis from an unknown date and unknown if ongoing inflammation from arthritis and take ibuprofen for inflammation. The patient's concomitant medications were not reported.  The patient experienced aching on an unspecified date with outcome of unknown, allergies (hypersensitivity) on an unspecified date with outcome of unknown.    Information about Lot/Batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site hypoaesthesia
Clinical narrative: I had like numbness in my face and along the left where I had the injection, like the left hand side on my body; I had like numbness in my face and along the left where I had the injection, like the left hand side on my body; This is a spontaneous report from a contactable consumer (patient).   A 70-years-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE),  via an unspecified route of administration in Feb2021 (reported as 3 weeks ago) (Batch/Lot number was not reported) single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced 'i had like numbness in my face and along the left where i had the injection, like the left hand side on my body' on Feb2021. The event outcome was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Malaise
Clinical narrative: didn't eat; didn't feel well; This is a spontaneous report from a contactable consumer (patient's herself) via Pfizer-sponsored program COVAX US Support. This 76-year old female patient received her second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 21Feb2021 (at the age of 76-year old) at single dose for COVID-19 immunization at the hospital. Relevant medical history included broken of tooth when she fell "on Oct3rd" for which an implant will be inserted and antibiotic therapy will be required. Concomitant medications were not reported. After the second dose the patient had gone all day without eating. The next day (Monday morning) she was fine but by the afternoon she didn't feel well but she didn't eat. The outcome of the events was unknown.   Follow-up attempts completed. Information about lot/batch number cannot be obtained.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: chills; Fever of 103 degrees Fahrenheit; Exhaustion; This is a spontaneous report from a contactable consumer.  A 29-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number was not reported), via an unspecified route of administration, in right arm on 23Feb2021 at 16:45 (at 29 years) at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. No known allergies. Previously on  02Feb2021 at 04:45 PM (at 29 years) patient took the first dose of the vaccine in right arm for covid-19 immunisation.On 24Feb2021at  01:00 am (also reported as approximately 12 hours after receiving the vaccination) the patient displayed symptoms of chills, exhaustion and a fever of 103 degrees Fahrenheit.No treatment given an outcome of the events was not recovered. No follow-up attempts are possible, information about batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; This is a spontaneous report from a contactable consumer (patient). A 65-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), dose 1 via an unspecified route of administration, administered in Arm Left on 26Jan2021 14:45 (Batch/Lot Number: EL9264) as single dose for COVID-19 immunisation. The patient had no medical history. The patient's concomitant medications were not reported. No other vaccine in four weeks. On 27Jan2021 08:00 AM, the patient experienced headache. She took Ibuprofen for headache. No covid prior vaccination and not tested post vaccination. Outcome of the event was recovered.  No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report from a contactable consumer (patient reported herself). A 62-year-old non-pregnant female patient received first dose of BNT162B2 (COVID 19, Pfizer, Solution for injection) via an unspecified route of administration to her right arm on 15Feb2021 11:30 AM (Lot number: el9267) as single dose for Covid-19 immunization. Facility type vaccine: School or Student Health Clinic. No other vaccine received in four weeks. The patient's medical history included known allergies: sulfa. Vaccine facility, ethnicity and race information were available. Concomitant medication included dimenhydrinate (DRAMAMINE, other medications in two weeks). On 22Feb2021 09:00 PM, the patient experienced hives. AE resulted in Doctor or other healthcare professional office/clinic visit. COVID was not tested prior or post vaccination. The events were assessed as non-serious. The patient received prednisone shot as a treatment for the event. Outcome of the event was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: broke out in hives; when my left side of my neck began itching; This is a spontaneous report from a contactable consumer (Patient). A 68-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection; Lot Number: EM9809) via an unspecified route of administration in Left Arm on 11Feb2021 11:00 am as 1st dose, SINGLE for COVID-19 immunization. Medical history included high blood pressure, hypothyroid, known allergies: penicillin, other allergies to unknown substances (known allergies: penicillin, other allergies to unknown substances). Patient's concomitant medications were not reported. Facility type vaccine: Other. On 11Feb2021 21:00, the patient experienced broke out in hives and when my left side of my neck began itching. Patient reported: I received the vaccination at 11:15 a.m. All went well, until 9:00 p.m. that night, when my left side of my neck began itching, I broke out in hives. I have a photo of the hives. Took two benedryl, hives eventually went away that night. AE resulted in: [Doctor or other healthcare professional office/clinic visit. If treatment AE: Yes, AE treatment: took benedryl followed up with office visit. if covid prior vaccination: No. If covid tested post vaccination: No. The clinical outcome of event broke out in hives was recovered on an unspecified date and for another event outcome was unknown.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: Within 4 hours I broke out in hives starting on scalp, then stomach. Next day both legs, then up stomach, include breasts. On arms. On day 3 my upper chest area, up neck and face; This is a spontaneous report received from a contactable Consumer (patient). A 71-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN5318, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 19Feb2021 13:00 (at the age of 71-year-old) as single dose for COVID-19 immunisation. The patient medical history included asthma and Guillain-Barre syndrome (in 1972). The patient had no allergies. Concomitant medication included omeprazole, cetirizine, fluticasone propionate, salmeterol (WIXELA INHUB) and montelukast sodium (SINGULAIR). The patient did not any other vaccine in four weeks. The patient did not have COVID prior to vaccination. The patient was not tested for COVID post vaccination. The patient reported that she took first dose of COVID vaccine on 19Feb2021 at 13:00 and within 4 hours (at 17:00) she broke out in hives starting on her scalp and then her stomach. Next day both legs, then up her stomach to include her breasts. On her arms and on day 3 my upper chest area up her neck and face. The patient visited the physician office. The patient received Cetirizine 4x day and Pepic 20 mg 4x day as treatment. The outcome of the event was reported as recovering.