chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Asthma, COVID-19, Cough, Influenza, X-ray
Clinical narrative: Patient informed me via Instant Message that she had a reaction to her 2nd dose of PFE vaccine...it exacerbated her asthma.  She saw her PCP March 25, 2021 who sent her on to the ER where they ga; Patient informed me via Instant Message that she had a reaction to her 2nd dose of PFE vaccine...it exacerbated her asthma.  She saw her PCP March 25, 2021 who sent her on to the ER where they ga; This is a spontaneous report from a contactable consumer. This consumer reported for patient that. An unspecified age female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EP7534), via an unspecified route of administration on 19Mar2021 as Dose 2, SINGLE for covid-19 immunization. The patient medical included asthma from an unknown date. The patient concomitant drugs include Prednisone 60 mg start date and stop dates were unknown. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: ENG202) on 26Feb2021 for covid-19 immunisation. On 20MAR2021 the patient experienced Coughing and asthma. She used an inhaler for 5 days but it wasn't working that well. When she called her doctor, they suggested that she go to the ER. She has a past medical history of asthma but has not had an episode this bad since she was a child. At the ER on 25Mar2021 she was tested for Covid and resulted negative, Flu, and X-ray they were all in normal range. She received 60mg of prednisone in the hospital and was released on a 5-day Prednisone starting with 50mg and then going down. The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Vaccination site urticaria
Clinical narrative: itching; COVID arm; This is a spontaneous report based on the information received by Pfizer: NUS2021US039669) from a contactable consumer (patient).  A 62-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. After the 4 weeks of vaccinated on an unspecified date the patient experienced itching, and COVID arm. The patient stated she used a topical gel prescription to treat her symptoms including itching. The outcome of events unknown  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Oesophageal pain, Vomiting
Clinical narrative: Nausea; Vomiting; Headache; Burning in esophagus; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EP7534) via an unspecified route of administration in the arm left on 21Mar2021 at 17:00 (at the age of 56-years-old) as a single dose for COVID-19 immunisation. The medical history included hyperthyroidism. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The concomitant medications included lamotrigine (LAMICTAL), gabapentin (MANUFACTURER UNKNOWN), duloxetine hydrochloride (CYMBALTA), baclofen (MANUFACTURER UNKNOWN) and fluoxetine hydrochloride (PROZAC); all taken for unknown indications from unknown dates and unknown if ongoing. On 23Mar2021, the patient experienced nausea, vomiting, headache and burning in esophagus. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the reported events and included treatment with ondansetron (ZOFRAN). Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events nausea, vomiting, headache and burning in esophagus was not recovered at the time of this report.    No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Vertigo in the middle of the night andthe next morning.; Then dizzy and just off for a few more hours.; This is a spontaneous report from a contactable consumer, the patient. A 56-year-old female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8730) via an unspecified route of administration in the left arm on 26Mar2021 at 10:00 (at the age of 56-year-old) as a single dose for COVID-19 immunisation. Medical history included history of blood clots. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ASPIRIN for the indication blood clot and its ongoing. Concomitant medications also included VITAMIN C, GLUCOSAMINE, ZINC, and MAGNESIUM, all for an unknown indication from an unknown dates and unknown if ongoing. On 27Mar2021 at 03:00, the patient experienced vertigo in the middle of the night and the next morning. Then on the same day dizzy and just off for a few more hours. The events did not result in doctor or other health care professional office or clinic visit and emergency room or department or urgent care. No therapeutic measures were taken as a result of the reported events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events dizzy and vertigo were resolving at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Hypoaesthesia, Hypoaesthesia eye, Lip disorder
Clinical narrative: Loss of smell; Loss of taste; My face become numb; it was hard to manipulate my tongue; it has moved up toward my eyes are becoming numb as well.; my lips became stiff; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date not reported), via an unspecified route of administration on 22Mar2021 08:00 (at the age of 65 years) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 22Mar2021 20:00, almost exactly 12 hours later, patient lost all sense of smell and taste for about an hour, his face become numb like he went to a dentist with novacaine shot (intent: reference), his lips became stiff, and it was hard to manipulate the tongue. It was reported that, this has continued till the current date, and it has moved up toward his eyes are becoming numb as well. Patient reported that, taste and smell came back after an hour, but it comes and goes and its ability, means its sensitivity is 30% past. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tongue movement disturbance
Clinical narrative: Loss of smell; Loss of taste; My face become numb; it was hard to manipulate my tongue; it has moved up toward my eyes are becoming numb as well.; my lips became stiff; This is a spontaneous report from a contactable consumer (patient). A 65-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration date not reported), via an unspecified route of administration on 22Mar2021 08:00 (at the age of 65 years) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 22Mar2021 20:00, almost exactly 12 hours later, patient lost all sense of smell and taste for about an hour, his face become numb like he went to a dentist with novacaine shot (intent: reference), his lips became stiff, and it was hard to manipulate the tongue. It was reported that, this has continued till the current date, and it has moved up toward his eyes are becoming numb as well. Patient reported that, taste and smell came back after an hour, but it comes and goes and its ability, means its sensitivity is 30% past. The outcome of all events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chills, Pyrexia
Clinical narrative: chills; fever; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received pneumonia vaccine (manufacturer unknown), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as DOSE NUMBER UNKNOWN, SINGLE for immunisation; influenza vaccine (manufacturer unknown), via an unspecified route of administration on an unspecified date (at the same time with pneumonia vaccine) (Batch/Lot number was not reported) at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced chills and fever on an unspecified date. She told the pharmacist about the adverse effects and pharmacist told her they were not from the flu shot, it was because she got the pneumonia shot. The outcome was unknown.   Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] has submitted the same report to the regulatory authorities.  No follow-up attempts are needed. Information about lot/batch number can not be obtained.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Migraine, Vertigo
Clinical narrative: Vertigo; Migraine; Chills; This is a spontaneous report from a non-contactable consumer, the patient.  A 32-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 19Mar2021 at 12:30 (at the age of 32-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient had no known allergies to medications, food, or other products. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included vitamin d nos (VITAMIN D) and echinacea (MANUFACTURER UNKNOWN); both for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. On 28Mar2021 at 11:00, the patient experienced vertigo, migraine and chills. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events vertigo, migraine and chills was resolving at the time of this report.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: Strong metal taste in the mouth approximately 2 hours after vaccination.; This is a spontaneous report from a contactable consumer, the patient. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER2613) via an unspecified route of administration in the left arm on 25Mar2021 at 15:15 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included migraine headaches and Gastroesophageal reflux disease (GERD. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included pantoprazole (MANUFACTURER UNKNOWN) for an unknown indication from an unknown date and an unknown if ongoing. The patient previously took paracetamol / oxycodone hydrochloride / oxycodone terephthalate (PERCOCET), topiramate (TOPAMAX) and cefalexin monohydrate (KEFLEX); all for unknown indications on an unknown date and experienced drug allergy. On 25Mar2021 at 17:30, approximately 2 hours after vaccination, the patient experienced strong metal taste in mouth. It had not dissipated after 3 full days. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event strong metal taste in mouth was not resolved at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling
Clinical narrative: her arm swelled up; redness; This is a spontaneous report from a contactable consumer. This consumer reported for patient (mother) that: An 69-years-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: EN6204) via an unspecified route of administration, administered in left arm on18Mar2021 as Dose 2 SINGLE for covid-19 immunization (Age at vaccination was 69-year-old). The patient medical was none reported. The patient did not have any concomitant drugs was reported. The patient received first dose of BNT162B2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Lot number: EN6205) on 25Feb2021 for covid-19 immunisation. On an unspecified date the patient's arm swelled up and redness turned a little bit. The reporter reported that the patient had a reaction with the second shot on 18Mar2021. When probed for consumer's weight, reporter stated that was on and off 145 (Pounds). The patient received treatment for the event Swelling arm with Benadryl and capsule of Aleve. The outcome of the event swelling arm was recovering while outcome of redness was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Limb discomfort, Myalgia
Clinical narrative: if she lifted both arms up she could tell which arm had the shot; muscle pain in upper arms and thighs; Chills; joint pain in hip and knee joints; This is a spontaneous report from a contactable consumer. A 76-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Solution for injection, Lot Number: not reported), via an unspecified route of administration on 08Feb2021 17:10 as DOSE 2, SINGLE for covid-19 immunisation (at the age of 76 years). Previously patient took first dose of Covid-19 vaccination in left arm on 15Jan2021 (Batch/lot number: EL8982; expiry date: May2021) for Covid-19 immunisation. Medical history included Diabetes , High cholesterol , visual impairment. Concomitant medications included atorvastatin 10 mg, 1x/day taken for blood cholesterol increased; metformin 500 mg, 2x/day orally taken for diabetes mellitus. History of all previous immunization with the Pfizer vaccine considered as suspect was none. The patient experienced muscle pain in upper arms and thighs, chills, joint pain in hip and knee joints on 12Mar2021; if she lifted both arms up she could tell which arm had the shot on an unspecified date. It was reported that Caller received her Pfizer Covid19 vaccination second shot on 08Feb2021 at 17:10. Caller stated she was experiencing muscle pain in both thighs and upper arms, chills and joint pain. Caller stated that the main one in muscle pain, it is hard to get up and down and hard to get in and out of the car. She stated these symptoms all started around 12Mar2021. The muscle pains are not equally troublesome all the time but it never disappears. The chills come and go. The joint pain is intermittent. Caller states that the muscle pain is the main/worst one, then the chills are second and the joint pain is third in severity. She started taking two Tylenol in the morning and at night, but she just started that about 3 days ago. She clarified that she was taking Acetaminophen, 500mg caplet, takes two caplets twice per day provided NDC: 69842-484-90, as well as a number that is beside the UPC-923789, and then directly under the UPC: 5042831899. Caller stated that if she lifted both arms up she could tell which arm had the shot, but that was all.   No follow-up attempts are possible: Information about lot/batch number cannot be obtained
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Erythema, Lymphadenopathy, Myalgia, Nausea
Clinical narrative: It is itchy and red; spiked a fever of 102.1; muscle pain; body aches; She first experienced nausea in the afternoon of getting the shot; she is experiencing a swollen lymph node on her neck after she got the 1st shot of the Covid-19 vaccine; It is itchy and red; This is a spontaneous report received from Pfizer sponsored program COVAX US Support from a contactable consumer (patient).  A 52-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 at 09:45 (at the age of 52years old) (Batch/Lot Number: EP6955) as dose 1, single for covid-19 immunisation. Medical history included Covid-19 in Apr2020 fully recovered. No allergies. Concomitant medication(s) included zinc, biotin, Woman Centrum and calcium carbonates (CALTRATE [CALCIUM CARBONATE]), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, at 14:00 hrs, she first experienced nausea in the afternoon of getting the shot, at 20:00, she had muscle pain and body aches. On 24Mar2021, at 01:00 hrs in the night, she spiked a fever of 102.1. On an unspecified date in 2021, she experienced a swollen lymph node on her neck, she added that it was not painful but it was itchy and red. She wanted to know what she should do about the symptoms that she was currently experiencing. The patient underwent lab tests and procedures which included body temperature 102.1 on 24Mar2021. No treatment was received for the adverse events (nausea, fever, muscle pain and body aches). The outcome of nausea, muscle pain and body aches, fever was recovering and outcome was unknown for swollen lymph node on her neck, it was itchy and red.  Follow-up attempts are completed. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Pyrexia
Clinical narrative: It is itchy and red; spiked a fever of 102.1; muscle pain; body aches; She first experienced nausea in the afternoon of getting the shot; she is experiencing a swollen lymph node on her neck after she got the 1st shot of the Covid-19 vaccine; It is itchy and red; This is a spontaneous report received from Pfizer sponsored program COVAX US Support from a contactable consumer (patient).  A 52-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 at 09:45 (at the age of 52years old) (Batch/Lot Number: EP6955) as dose 1, single for covid-19 immunisation. Medical history included Covid-19 in Apr2020 fully recovered. No allergies. Concomitant medication(s) included zinc, biotin, Woman Centrum and calcium carbonates (CALTRATE [CALCIUM CARBONATE]), all taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 23Mar2021, at 14:00 hrs, she first experienced nausea in the afternoon of getting the shot, at 20:00, she had muscle pain and body aches. On 24Mar2021, at 01:00 hrs in the night, she spiked a fever of 102.1. On an unspecified date in 2021, she experienced a swollen lymph node on her neck, she added that it was not painful but it was itchy and red. She wanted to know what she should do about the symptoms that she was currently experiencing. The patient underwent lab tests and procedures which included body temperature 102.1 on 24Mar2021. No treatment was received for the adverse events (nausea, fever, muscle pain and body aches). The outcome of nausea, muscle pain and body aches, fever was recovering and outcome was unknown for swollen lymph node on her neck, it was itchy and red.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: Facial tingling on the left side jaw area; This is a spontaneous report from a contactable consumer, the patient. A 34-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8727) via an unspecified route of administration in the right arm on 23Mar2021 at 17:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. Medical history included Human Immunodeficiency Virus (HIV) and hyperhidrosis. The patient had no known allergies to medications, food, or other products. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included oxybutynin (MANUFACTURER UNKNOWN), emtricitabine, rilpivirine hydrochloride, tenofovir alafenamide fumarate (ODEFSEY) and doxycycline (MANUFACTURER UNKNOWN), all taken for an unspecified indication from an unknown date and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot number: EN6205) via an unspecified route of administration in the right arm on 02Mar2021 at 17:00 (at the age of 34-years-old) as a single dose for COVID-19 immunisation. On 23Mar2021 at 17:30, 20 or 30 minutes after receiving the second dose of Pfizer COVID-19 vaccine, the patient experienced facial tingling on the left side jaw area. Facial tingling reoccurred the following day, 24Mar2021 at 20:30 and was present while filling out this report. The event did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event facial tingling on the left side jaw area was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: second shot was received- rash became worse; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 63-years-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 16Mar2021 13:30 (at the age of 63-year-old) as dose 2, single for covid-19 immunisation. Medical history included allergies: Senna laxatives, breast cancer from an unknown date and unknown if ongoing, psoriasis from an unknown date and unknown if ongoing, Rosacea from an unknown date and unknown if ongoing. Concomitant medications included anastrozole (ANASTRAZOLE DENK) taken for an unspecified indication, start and stop date were not reported; levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient previously took BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: unknown) via an unspecified route of administration on 22Feb2021 (age at vaccination 63-year-old) as a single dose for COVID-19 immunization and experienced itchy rash all over body, thought it was hives. On an unspecified date in 2021, the patient experienced second shot was received- rash became worse. Clinical course: 3 days after first vaccine, itchy rash all Over body - thought it was hives, rash continued and second shot was received- rash became worse, now 2 weeks after second rash and 6 days course of steroids, Rash is still present and worse as steroids tapered. Therapeutic measures were taken as a result of second shot was received- rash became worse included Zyrtec and Steroids. The event resulted in doctor or other health care professional office/clinic visit. The outcome of the event was not recovered.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Balance disorder, Chills, Dizziness
Clinical narrative: felt very weak; nausea; joint pain in my legs; severe dizziness; that I lost balance; vomiting; chills; strong headache; This is a spontaneous report from a contactable consumer (patient).   A 57-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, solution for injection; Lot Number: EP 7534) via an unspecified route of administration, administered in arm left on 20Mar2021 at 17:15 as dose 1, single (at the age of 57-years old) for covid-19 immunisation. The patient medical history was reported as none. Patient was not pregnant at the time of vaccination. The patient did not have allergies to medications, food, or other products were reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 28Mar2021 at 04:00, on Sunday, the patient experienced severe dizziness, that she lost balance, vomiting, chills and strong headache. Patient spent the day resting, hydrating and took (colecalciferol retinol) ADVIT (2 tablets). On 29Mar2021, on Monday, the patient felt very weak and experienced nausea, headache and joint pain in her legs. Patient took another dose of (colecalciferol retinol) ADVIT (2 tablets), she continued hydration. she felt better. It was possible to have side effect after 8 days of receiving the first dose. Since the vaccination, patient has not been tested for COVID-19. Therapeutic measures was taken as a result of all events ADVIT (2 tablets) and auto medication. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vomiting
Clinical narrative: felt very weak; nausea; joint pain in my legs; severe dizziness; that I lost balance; vomiting; chills; strong headache; This is a spontaneous report from a contactable consumer (patient).   A 57-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, solution for injection; Lot Number: EP 7534) via an unspecified route of administration, administered in arm left on 20Mar2021 at 17:15 as dose 1, single (at the age of 57-years old) for covid-19 immunisation. The patient medical history was reported as none. Patient was not pregnant at the time of vaccination. The patient did not have allergies to medications, food, or other products were reported. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient did not receive other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. On 28Mar2021 at 04:00, on Sunday, the patient experienced severe dizziness, that she lost balance, vomiting, chills and strong headache. Patient spent the day resting, hydrating and took (colecalciferol retinol) ADVIT (2 tablets). On 29Mar2021, on Monday, the patient felt very weak and experienced nausea, headache and joint pain in her legs. Patient took another dose of (colecalciferol retinol) ADVIT (2 tablets), she continued hydration. she felt better. It was possible to have side effect after 8 days of receiving the first dose. Since the vaccination, patient has not been tested for COVID-19. Therapeutic measures was taken as a result of all events ADVIT (2 tablets) and auto medication. The outcome of the events was recovering.   No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Dyspnoea
Clinical narrative: Hard to breathe; Having a sharp pain in her back "where her lung was"; This is a spontaneous report from a contactable consumer or other non-health care professional (patient) reported herself.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on Saturday at noon in Mar2021 (Lot number was not reported) as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 28Mar2021 the patient experienced a sharp pain in her back where her lung was and she was hard to breathe on 29Mar2021. The patient stated that she received her first covid vaccine dose on Saturday at noon and last night she began having a sharp pain in her back 'where her lungs were'. She reported that she thought it would go away last night but when she woke up it was still there and its now hard to breathe. The outcome of the event hard to breathe was unknown. The outcome of the event having a sharp pain in her back where lung was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Chest pain, Feeling hot, Hypoaesthesia
Clinical narrative: When they administered it he felt it was burning; His palm went numb/ was feeling my left arm with pain and also that was like my arm was numb; Pain on the left side of his hand and on the joints/ I was feeling my left arm with pain and also that was like my arm was numb; It was burning like when they put the vaccine; in my body I feel burning right away in the arm, the right one.; Feel some pain like in my chest; He had muscle pain on the left side and "behind the back"/ i  feel some pain like in my chest; muscle what in the heart right there and also in my back.; He felt very hot at the site; I have little pain in my back; This is a spontaneous report received from a contactable consumer or other non hcp. A 34-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown, Expiry Date of Covid 19 Vaccine: Un-known) via an unspecified route of administration in Arm Right on 26Mar2021 (age at vaccination 34years old) as single dose for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced when they administered it, he felt it was burning, his palm went numb/ was feeling my left arm with pain and also that was like my arm was numb, pain on the left side of his hand and on the joints/ I was feeling my left arm with pain and also that was like my arm was numb, it was burning like when they put the vaccine; in my body I feel burning right away in the arm, the right one, feel some pain like in my chest, he had muscle pain on the left side and "behind the back"/ I feel some pain like in my chest; muscle what in the heart right there and also in my back, he felt very hot at the site, I have little pain in my back on Mar2021. He got the first dose of Pfizer's COVID-19 vaccine last Friday on the right arm, but when they administered it, he felt it was burning, he felt very hot at the site. Four hours later he started feeling pain on the left side of his hand and on the joints and his palm went numb. On the chest, he had muscle pain on the left side and behind the back. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site pain
Clinical narrative: When they administered it he felt it was burning; His palm went numb/ was feeling my left arm with pain and also that was like my arm was numb; Pain on the left side of his hand and on the joints/ I was feeling my left arm with pain and also that was like my arm was numb; It was burning like when they put the vaccine; in my body I feel burning right away in the arm, the right one.; Feel some pain like in my chest; He had muscle pain on the left side and "behind the back"/ i  feel some pain like in my chest; muscle what in the heart right there and also in my back.; He felt very hot at the site; I have little pain in my back; This is a spontaneous report received from a contactable consumer or other non hcp. A 34-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: unknown, Expiry Date of Covid 19 Vaccine: Un-known) via an unspecified route of administration in Arm Right on 26Mar2021 (age at vaccination 34years old) as single dose for covid-19 immunisation. Medical history included drug hypersensitivity from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced when they administered it, he felt it was burning, his palm went numb/ was feeling my left arm with pain and also that was like my arm was numb, pain on the left side of his hand and on the joints/ I was feeling my left arm with pain and also that was like my arm was numb, it was burning like when they put the vaccine; in my body I feel burning right away in the arm, the right one, feel some pain like in my chest, he had muscle pain on the left side and "behind the back"/ I feel some pain like in my chest; muscle what in the heart right there and also in my back, he felt very hot at the site, I have little pain in my back on Mar2021. He got the first dose of Pfizer's COVID-19 vaccine last Friday on the right arm, but when they administered it, he felt it was burning, he felt very hot at the site. Four hours later he started feeling pain on the left side of his hand and on the joints and his palm went numb. On the chest, he had muscle pain on the left side and behind the back. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Urticaria
Clinical narrative: cold; developed hives; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced cold and developed hives. The patient was asking if the events were normal and how long they last. The outcome of the events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Bronchitis
Clinical narrative: Bronchitis; This is a spontaneous report from a contactable consumer via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 11Mar2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was diagnosed with bronchitis on 26Mar2021. She received an antibiotic injection. She was currently taking oral antibiotics. She wanted to know if she is eligible to receive the second dose of the vaccine. The outcome of the event was unknown.   No follow-up attempts are possible. Information about batch/lot number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Nasopharyngitis, Pyrexia
Clinical narrative: chills; fever; came down with a cold; This is a spontaneous report from a contactable consumer (patient) reported himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 09Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. The patient medical history was not reported. Concomitant medications included dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (NYQUIL) and dextromethorphan hydrobromide, guaifenesin, paracetamol, pseudoephedrine hydrochloride (DAYQUIL) taken for an unspecified indication, start and stop date were not reported. Patient report that this was not from the first COVID shot, explaining that patient had chills and a fever for a couple of nights and a few things listed as the common side effects but otherwise no reaction other than those listed on the information. Patient reported that, patient came down with a cold and taking Nyquil day and night. Patient scheduled second dose of the vaccine on 30Mar2021. Patient wanted to know can still get the second shot and patient has come down with a cold and was wondering if patient can get the second dose with a cold because patient has been self dosing with Dayquil and Nyquil. The outcome of the events were unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient, of an unspecified age, received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. On an unspecified date (five days after the vaccination), patient experienced swollen lymph node in throat on the opposite side of the injection site. The patient wanted to know what to expect on the second dose of the vaccine. The outcome of the event: unknown. No follow-up attempts possible. Information about lot/batch number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I broke out with a rash, not a bad a rash. It isn't itchy. It's on my legs and hands.; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced broke out with a rash, not a bad a rash, it was not itchy, it was on her legs and hands on an unspecified date. The outcome of event was unknown. The patient asked if she do not get the 2nd dose, do she get a protection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Feeling cold, Neck pain, Vaccination site reaction
Clinical narrative: cold sensation on her left shoulder (injection site) going to her neck/ as if the coldness was travelling through her veins/ cold sensation was travelling throughout her body; cold sensation on her left shoulder (injection site) going to her neck/ as if the coldness was travelling through her veins/ cold sensation was travelling throughout her body; sharp shooting pain that travelled from her right shoulder to her neck, and then to her chest; sharp shooting pain that travelled from her right shoulder to her neck, and then to her chest; sharp shooting pain that travelled from her right shoulder to her neck, and then to her chest; This is a spontaneous report from a non-contactable consumer (patient) via Medical Information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in the left arm (reported as left shoulder) on an unspecified date in Mar2021 as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient said she received the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine 3 weeks prior. Four or five hours after receiving the 1st dose of the vaccine (on an unspecified date in Mar2021), the patient felt a cold sensation on her left shoulder (injection site) going to her neck. She said it felt as if the coldness was travelling through her veins. The patient took paracetamol (TYLENOL) to treat the symptoms, and it went away after an hour. However, 2 weeks after the 1st dose (on an unspecified date in Mar2021), she felt a sharp shooting pain that travelled from her right shoulder to her neck, and then to her chest. The patient said the cold sensation was travelling throughout her body. The patient wanted to know if this was related to the vaccine. The patient was worried because her 2nd dose is on 05Apr2021, and she did not know if she should get it. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Fatigue, Feeling abnormal, Headache
Clinical narrative: felt dizzy; had a headache; felt tired; have pain in my arm where i got the injection; Yawning; Joint pain; Achy/ liitle pain; Still feel bad/not just feeling good; legs hurt; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8732, Expiry date: Jul2021), via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received his 1st dose on Friday 26MAR2021, and Friday he was ok, but when he got home and all weekend he felt dizzy, had a headache, felt tired, and have pain in his arm where he got the injection. He had been tired and achy all over and he got a little pain. Patient further explained that, when he first got it on 26th, he felt okay. They let him sit down for few minutes, about 20 minutes then he just came home and he was just so like achy, tired dizzy, headache and he was yawning. He was still tired, achy, dizzy, his joints were, everything. He was not just feeling good. His legs hurt and he still felt bad. Patient stated he was still dizzy, he still had little headache and tired. Patient second dose was scheduled on 16Apr2021, 12:00. The clinical outcome for the events was not recovered except unknown for legs hurt and have pain in my arm where i got the injection.  No follow-up attempts are needed. No further information is expected.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site pain, Yawning
Clinical narrative: felt dizzy; had a headache; felt tired; have pain in my arm where i got the injection; Yawning; Joint pain; Achy/ liitle pain; Still feel bad/not just feeling good; legs hurt; This is a spontaneous report from a contactable consumer (patient) via Pfizer. A 54-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: ER8732, Expiry date: Jul2021), via an unspecified route of administration in the left arm on 26Mar2021 (at the age of 53-years-old) as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient received his 1st dose on Friday 26MAR2021, and Friday he was ok, but when he got home and all weekend he felt dizzy, had a headache, felt tired, and have pain in his arm where he got the injection. He had been tired and achy all over and he got a little pain. Patient further explained that, when he first got it on 26th, he felt okay. They let him sit down for few minutes, about 20 minutes then he just came home and he was just so like achy, tired dizzy, headache and he was yawning. He was still tired, achy, dizzy, his joints were, everything. He was not just feeling good. His legs hurt and he still felt bad. Patient stated he was still dizzy, he still had little headache and tired. Patient second dose was scheduled on 16Apr2021, 12:00. The clinical outcome for the events was not recovered except unknown for legs hurt and have pain in my arm where i got the injection.  No follow-up attempts are needed. No further information is expected.