chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia, Photophobia, Vaccination site pain
Clinical narrative: Injection site pain; muscle pain; joint pain; tingling; headache; sensitivity to light and sound; chest tightness; body aches; This is a spontaneous report from a non-contactable consumer, patient. A 31-year-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: En6204), via an unspecified administrated in the left arm on 27Mar2021 at 10:45 hours as a single dose for COVID-19 immunisation (at the age of 31-years-old). Medical history not provided. Concomitant medications included metformin (MANUFACTURER UNKNOWN), spironolactone (MANUFACTURER UNKNOWN), sertraline (MANUFACTURER UNKNOWN) for an unknown indication. Previously patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6205), via an unspecified administrated in the left arm on 4March2021 as a single dose for COVID-19 immunisation (at the age of 31-years-old). The patient did not receive any other vaccines within 4 weeks prior to the vaccine. Since the vaccination, the patient was not tested for COVID-19. On 27March2021, at 12:45 hours patient experienced injection site pain, muscle pain, joint pain, tingling, headache, sensitivity to light and sound, chest tightness, body aches. Prior to vaccination, the patient was not diagnosed with COVID-19. Therapeutic measures were not taken as a result of the event. Clinical outcome of the Injection site pain, muscle pain, joint pain, tingling, headache, sensitivity to light and sound, chest tightness, body aches was recovering at the time of reporting. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram, Cough, Myalgia, Pain, Skin irritation
Clinical narrative: skin irritation.; felt like a pulled muscle under my left rib cage about 1 hour after the shot.  Thought I just pulled a muscle some how but the next day I sneezed and the pain was incredible.; I'm in severe pain.; cough; sneeze; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732, Expiration date: Not reported), via an unspecified route of administration, administered in right arm on 26Mar2021 18:30 (at the age of 60-years-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included diabetes, asthma, glaucoma, tinnitus, Known Allergies: raw apples make my mouth itch. Concomitant medication(s) and received within 2 weeks of vaccination included solifenacin, losartan, tadalafil, atorvastatin. The patient had allergies with raw apples makes mouth itch. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient filed this information in the initial report but got the vaccine on 26Mar2021 Friday and maybe 1-2 hours after that he thought he pulled a muscle somehow under his ribcage area and the next day on Saturday he still felt it but it was not a big deal. States then he sneezed while he was driving his car and almost crashed and the pain was incredible and was one of the most painful things he has had happen. States he couldn't believe this and then when he went home and bought Salon Pas which are those heat things that heat up and he is using so many of them but they are causing skin irritation. States he went to the emergency room on Monday but according to him people showed no interest and was not quite alarmed of the situation even though they do not know what is it specifically. His physician, prescribed him with the cough syrup because if he coughs or sneezes was when it really really hurts him and hurts more when he sneezes and oxycodone for the pain which he didn't took. He also mentioned that physician requested for a CAT Scan which didn't show anything on the results Normal. He is also scheduled for his second shot tomorrow. The adverse event resulted in emergency room/department or urgent care visit. The patient did not receive any treatment. Outcome of the event skin irritation was unknown, while that for other events was not recovered, at the time of this report.  Information about lot/batch number cannot be obtained. No follow-up attempts are needed. No further information is expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Sneezing
Clinical narrative: skin irritation.; felt like a pulled muscle under my left rib cage about 1 hour after the shot.  Thought I just pulled a muscle some how but the next day I sneezed and the pain was incredible.; I'm in severe pain.; cough; sneeze; This is a spontaneous report from a contactable consumer, the patient. A 60-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732, Expiration date: Not reported), via an unspecified route of administration, administered in right arm on 26Mar2021 18:30 (at the age of 60-years-old) as DOSE 1, SINGLE for covid-19 immunization. Medical history included diabetes, asthma, glaucoma, tinnitus, Known Allergies: raw apples make my mouth itch. Concomitant medication(s) and received within 2 weeks of vaccination included solifenacin, losartan, tadalafil, atorvastatin. The patient had allergies with raw apples makes mouth itch. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient filed this information in the initial report but got the vaccine on 26Mar2021 Friday and maybe 1-2 hours after that he thought he pulled a muscle somehow under his ribcage area and the next day on Saturday he still felt it but it was not a big deal. States then he sneezed while he was driving his car and almost crashed and the pain was incredible and was one of the most painful things he has had happen. States he couldn't believe this and then when he went home and bought Salon Pas which are those heat things that heat up and he is using so many of them but they are causing skin irritation. States he went to the emergency room on Monday but according to him people showed no interest and was not quite alarmed of the situation even though they do not know what is it specifically. His physician, prescribed him with the cough syrup because if he coughs or sneezes was when it really really hurts him and hurts more when he sneezes and oxycodone for the pain which he didn't took. He also mentioned that physician requested for a CAT Scan which didn't show anything on the results Normal. He is also scheduled for his second shot tomorrow. The adverse event resulted in emergency room/department or urgent care visit. The patient did not receive any treatment. Outcome of the event skin irritation was unknown, while that for other events was not recovered, at the time of this report.  Information about lot/batch number cannot be obtained. No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: Experienced menstrual cycle after vaccine shot; This is a spontaneous report from a non-contactable consumer (patient) via. This is a First of two reports. A 4-decade-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced menstrual cycle after vaccine shot. She did not know how soon after the vaccine it occurred. She reported it was just unexpected. As per the report, the information was from third party from (social media site group name). Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021288751 Same reporter, drug and event, different patient
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dysgeusia, Fatigue, Nausea, Regurgitation
Clinical narrative: problems with her stomach; She has a bit of fluid coming back and acid and a bitter taste in her mouth.; She has a bit of fluid coming back and acid and a bitter taste in her mouth.; she has fatigue, she is so tired she can't get up; she has fatigue, she is so tired she can't get up; nausea; This is a spontaneous report received from a contactable consumer or other non hcp. A elderly female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number was not reported) via an unspecified route of administration on 26Mar2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced her first Pfizer covid vaccine on 26Mar2021. She had a little nausea for the first three days, but it was fine. Now on the 6th and 7th day, she has fatigue, she is so tired she can't get up and what worries her more is problems with her stomach. She is not bringing food down. She has a bit of fluid coming back and acid and a bitter taste in her mouth. She has not been eating anything spicy or salty and has had the same diet. She is worried about her liver. Is this related to the vaccine Age 66 unit attempted transfer to safety, but all agents were busy. The clinical outcome of the event nausea recovered and other was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Colonoscopy, Ear congestion, Erythema, Hypersensitivity, Lymphadenopathy
Clinical narrative: Mild allergic reaction in first 30 mintues; swollen glands; ears clogging; puffy eyes; sore throat; itchy skin random spot and at injection spot; turned red all over; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, Solution for Injection, Batch/Lot number: EN6284), via an intramuscular route in arm left on 17Mar2021 at 17:30 (at the age of 34-year-old), as a single dose for covid-19 immunization at Health Department. The patient medical history included appendix removed, surgery in 2004, gall bladder removed, surgery in 2003, colon polyps, surgery colonoscopy in 2015 and acid reflux, slow emptying emptying test (2000) at the age of 12 (ongoing). Allergies to medications, food, or other products: Shellfish, leviquinn, augmentine, environmental, drug and food allergies for which patient has taken allergies shots 1997 to 2000 and prescribe treatment of meds, allergies that induce asthma, no glad bladder and appendix acid reflux Ibs, reaction to vaccine and allergy. Concomitant medications included Ibuprofen for tooth pain, fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR), Inhaler for reaction to vaccine and allergies, everyday (No inhaler unless needed), orally and all were ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 17Mar2021, the patient experienced mild allergic reaction (reaction to shot) in first 30 minutes (reported as onset time: 20mins, 24 hours after), swollen glands, ears clogging, puffy eyes, turned red all over, sore throat, itchy skin random spots and at injection spot. She had allergic responses to both shots given. Therapeutic measures taken as a result of the events included doctor onsite advised dosing with 3 bendryls, through mouth 1 dose before and 2 after given shot stayed 30mins and monitored her. The most side effect became less after 1 hour and dosing with 3 bendryls 1 dose before and 2 after given shot. Patient had all side effects reported and were severe. Lasting 4 days after 1 shot. The outcome of the events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Periorbital swelling, Pruritus
Clinical narrative: Mild allergic reaction in first 30 mintues; swollen glands; ears clogging; puffy eyes; sore throat; itchy skin random spot and at injection spot; turned red all over; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received the first dose of BNT162B2 (Pfizer BioNTech COVID-19 vaccine, Solution for Injection, Batch/Lot number: EN6284), via an intramuscular route in arm left on 17Mar2021 at 17:30 (at the age of 34-year-old), as a single dose for covid-19 immunization at Health Department. The patient medical history included appendix removed, surgery in 2004, gall bladder removed, surgery in 2003, colon polyps, surgery colonoscopy in 2015 and acid reflux, slow emptying emptying test (2000) at the age of 12 (ongoing). Allergies to medications, food, or other products: Shellfish, leviquinn, augmentine, environmental, drug and food allergies for which patient has taken allergies shots 1997 to 2000 and prescribe treatment of meds, allergies that induce asthma, no glad bladder and appendix acid reflux Ibs, reaction to vaccine and allergy. Concomitant medications included Ibuprofen for tooth pain, fexofenadine hydrochloride (ALLEGRA), montelukast sodium (SINGULAIR), Inhaler for reaction to vaccine and allergies, everyday (No inhaler unless needed), orally and all were ongoing. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. On 17Mar2021, the patient experienced mild allergic reaction (reaction to shot) in first 30 minutes (reported as onset time: 20mins, 24 hours after), swollen glands, ears clogging, puffy eyes, turned red all over, sore throat, itchy skin random spots and at injection spot. She had allergic responses to both shots given. Therapeutic measures taken as a result of the events included doctor onsite advised dosing with 3 bendryls, through mouth 1 dose before and 2 after given shot stayed 30mins and monitored her. The most side effect became less after 1 hour and dosing with 3 bendryls 1 dose before and 2 after given shot. Patient had all side effects reported and were severe. Lasting 4 days after 1 shot. The outcome of the events was recovered on an unspecified date in Mar2021.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypersensitivity, Vaccination site pain
Clinical narrative: Had allergic responses to both shots given; So far 2nd shot is only hurting at injection site and joint pain.; So far 2nd shot is only hurting at injection site and joint pain.; This is a spontaneous report from a contactable consumer or other non hcp. A 34-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: ER8729 and Expiration date was not reported), via intramuscular route of administration, in Arm Right, on 09Apr2021 at 18:00 (at the age of 34 years) as a single dose for covid-19 immunisation. The patient medical history included allergy that induce asthma from an unknown date and unknown if ongoing, cholecystectomy from 2003 to an unknown date, appendix removed from 2004 to an unknown date, ongoing acid reflux slow emptying Onset age:12 Emptying test: 2000, tooth pain from an unknown date and unknown if ongoing, vaccine reaction, environmental drug allergies and food from an unknown date and unknown if ongoing (Allergic shot to 1997to2000+ prescribe treatment of meds), colon polyps from 2015 to an unknown date Surgery colonoscopy's and no gallbladder. Known allergies included shellfish, leviquinn, augmentine, environmental allergies. Concomitant medications included ibuprofen taken for toothache, loratadine (CLARITINE ALLERGY); diphenhydramine hydrochloride (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) taken for reaction to preservatives from 09Apr2021 to an unspecified stop date; cetirizine hydrochloride (ALEGRA) taken for reaction to preservatives from an unspecified start date and ongoing; montelukast sodium (SINGULAIR). The patient previously took Levaquin for hypersensitivity, augmentine [amoxicillin sodium; clavulanate potassium] for hypersensitivity. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: EN6284 and Expiration date was not reported), via intramuscular route of administration, in arm left, on 17Mar2021 at 5:30 PM, as a single dose for covid-19 immunisation and experienced puffy eyes, turned red all over, sore throat, itchy skin random spots, Ears clogging and swollen glands. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior vaccination patient had no COVID. Since the vaccination, patient has not been tested for COVID-19. On 09Apr2021, the patient had experienced only hurting at injection site and joint pain; On an unknown date, had allergic responses to both shots given. Patient was received treatment for events. Treatments include Benadryl 2 after shot stayed 30 min and Benadryl 4 pills+ inhaler 2 before 2 after stayed 40min. Doctor on site advised Benadryl and monitored patient. No relevant lab test was performed. The clinical outcome of all events was recovered on an unspecified date in 2021. The seriousness was reported as non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Menstruation irregular
Clinical narrative: Early period; Breast sensitivity; This is a spontaneous report from a contactable consumer (patient).   A 21-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8729), dose 2 via an unspecified route administration, administered in left arm on 13Apr2021 as dose 2, single for covid-19 immunization (at the age of 21years). Patient's historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP6955), dose 1 via an unspecified route administration, administered in left arm on 23Mar2021 as dose 1, single for covid-19 immunization. The patient medical history included birth control. The patient's concomitant medications were included ethinylestradiol, ferrous fumarate, norethisterone acetate (AUROVELA 24 FE) taken for birth control. Patient was not diagnosed with COVID-19 prior to the COVID vaccine and since the vaccination. Patient did not receive other vaccine within 4 weeks prior to the COVID vaccine. The patient had mild spotting after first dose. This was abnormal as she has been perfect on birth control pills for 6 months. The patient had not taken any treatment for reported events. The patient experienced early period and breast sensitivity start after second dose on an unspecified date in Apr2021. The outcome of the events was recovered on an unspecified date in Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular, Vaginal haemorrhage
Clinical narrative: Menstrual cycle irregularities; Mild spotting after first dose; This is a spontaneous report from a contactable consumer (patient). A 21-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration on 23Mar2021 (at the age of 21-year-old), as dose 1, single in left arm for COVID-19 immunisation at hospital. The patient's medical history was reported as none. Patient had no known allergies. Concomitant medication received within 2 weeks of vaccination included Aurovela Fe for duration of 6 months, taken as birth control pills, start and stop dates were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in 2021, the patient experienced menstrual cycle irregularities and mild spotting after first dose. This was abnormal as she had been perfect on birth control pills for 6 months. The patient did not receive any treatment for the events. The patient had no COVID prior vaccination and was not tested COVID post vaccination. The clinical outcome of the events was resolved in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: had their 1st dose on 29Mar2021 and are supposed to return on 19Apr2021, however, they were tested positive for Covid-19 virus on that day; Covid-19; This is a spontaneous report from a Pfizer-sponsored program. A contactable female consumer or other non-health care professional (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Expiry Date: unknown, Batch/Lot number: unknown), via an unspecified route of administration on 29Mar2021, as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated she and his husband had their 1st dose on 29Mar2021 and are supposed to return on 19Apr2021, however, they were tested positive for Covid-19 virus on that day so they weren't able to receive the 2nd shot. Now, she is calling to ask how to set up an appointment for their second dose. The patient underwent lab tests and procedures which included Covid-19 virus test: positive on an unspecified date. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021455010
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Pharyngitis streptococcal, SARS-CoV-2 test, Sinusitis
Clinical narrative: tested positive for Covid; tested positive for Covid; Had What I believed to be a sinus infection or strep throat; Had What I believed to be a sinus infection or strep throat; ringing in my ears; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient) reported that an unspecified age and gender patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 14Mar2021 as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 Immunization. Patient stated that Had my 2nd Pfizer shot 14Mar2021. I believed to be a sinus infection or strep throat on an unspecified date in 2021 and on 11Apr2021 went to doctor tested positive for COVID. Also have a ringing in my ears cannot say exactly if it is from the shots or not. On a good note had sinus like symptoms for only three days and that was the worst of it so apparently the Pfizer vaccine worked. Outcome of events vaccination failure, COVID-19 and Ringing in ears was unknown and for other events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tested positive for Covid; tested positive for Covid; Had What I believed to be a sinus infection or strep throat; Had What I believed to be a sinus infection or strep throat; ringing in my ears; This is a spontaneous report from a Pfizer sponsored program. A non-contactable consumer (patient) reported that an unspecified age and gender patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection) via an unspecified route of administration on 14Mar2021 as single dose for COVID-19 immunization. Patient medical history and concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 Immunization. Patient stated that Had my 2nd Pfizer shot 14Mar2021. I believed to be a sinus infection or strep throat on an unspecified date in 2021 and on 11Apr2021 went to doctor tested positive for COVID. Also have a ringing in my ears cannot say exactly if it is from the shots or not. On a good note had sinus like symptoms for only three days and that was the worst of it so apparently the Pfizer vaccine worked. Outcome of events vaccination failure, COVID-19 and Ringing in ears was unknown and for other events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. Information about lot or batch number cannot be obtained.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: Significant increase in menstrual bleeding in first period post vaccine. Period occurred within 3 week waiting period for 2nd dose; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: unknown), dose 1 intramuscular, administered in Arm Right on 12Apr2021 12:45 as DOSE 1, SINGLE for covid-19 immunisation administered at Pharmacy or Drug Store. Medical history included goitre. No known allergies. The concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination was Thyroid medication (unspecified). The patient experienced significant increase in menstrual bleeding in first period post vaccine. period occurred within 3 week waiting period for 2nd dose on an unspecified date in Apr2021. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The patient did not receive any treatment for the event. Covid was not tested prior vaccination or post vaccination. Outcome of event was recovered on an unspecified date in 2021.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Chest discomfort, Dysphagia, Dyspnoea, Heart rate increased
Clinical narrative: asthma-like conditions; tightness in her chest; tingling in her shoulders and right arm and across her chest; rapid heartbeat; nausea; tightness in her throat; she couldn't breathe; Asthma attacks; There were a couple nights where she was wide awake for 24 hrs; She is being treated for a severe allergic reaction; her throat was paralyzed; she couldn't swallow; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 13Mar2021 (at the age of 59-years-old) (Batch/Lot Number: EM9809) as 0.3ML single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that the initial thing was about 30 minutes after the vaccine and she couldn't swallow, her throat was paralyzed. She was at the hospital for 4 hours. She had nausea and covid symptoms and tightness in her throat but it was not super severe. It didn't feel like she couldn't breathe. There were a couple nights where she was wide awake for 24 hrs. She stated at first it was manageable but as time went on it started getting stronger. She stated she had seen a doctor about this. The patient had the second dose of the vaccine on 13mar2021 and since then had been having asthma-like conditions. She was being treated for a severe allergic reaction. The patient has had tightness in her chest, kind of tingling in her shoulders and right arm and across her chest. She had a rapid heartbeat which she had no control over and it comes on and goes away. She was trying to see if there was a pattern but in the morning she had the sharp hot things through shoulder and back and that brings on tightness in her chest and then asthma and this follows the same pattern every 3 days. She stated she had 2 days of nothing and then the night before [before the third day] she had a rapid heartbeat and the next morning had the hot tingling things, and then an asthma attack. She asked what it is that she might be having an allergic reaction to? The patient stated she already had a list of ingredients. She stated she will reach out to her doctor to discuss this further. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Insomnia, Nausea, Paraesthesia, Paralysis
Clinical narrative: asthma-like conditions; tightness in her chest; tingling in her shoulders and right arm and across her chest; rapid heartbeat; nausea; tightness in her throat; she couldn't breathe; Asthma attacks; There were a couple nights where she was wide awake for 24 hrs; She is being treated for a severe allergic reaction; her throat was paralyzed; she couldn't swallow; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 13Mar2021 (at the age of 59-years-old) (Batch/Lot Number: EM9809) as 0.3ML single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that the initial thing was about 30 minutes after the vaccine and she couldn't swallow, her throat was paralyzed. She was at the hospital for 4 hours. She had nausea and covid symptoms and tightness in her throat but it was not super severe. It didn't feel like she couldn't breathe. There were a couple nights where she was wide awake for 24 hrs. She stated at first it was manageable but as time went on it started getting stronger. She stated she had seen a doctor about this. The patient had the second dose of the vaccine on 13mar2021 and since then had been having asthma-like conditions. She was being treated for a severe allergic reaction. The patient has had tightness in her chest, kind of tingling in her shoulders and right arm and across her chest. She had a rapid heartbeat which she had no control over and it comes on and goes away. She was trying to see if there was a pattern but in the morning she had the sharp hot things through shoulder and back and that brings on tightness in her chest and then asthma and this follows the same pattern every 3 days. She stated she had 2 days of nothing and then the night before [before the third day] she had a rapid heartbeat and the next morning had the hot tingling things, and then an asthma attack. She asked what it is that she might be having an allergic reaction to? The patient stated she already had a list of ingredients. She stated she will reach out to her doctor to discuss this further. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: asthma-like conditions; tightness in her chest; tingling in her shoulders and right arm and across her chest; rapid heartbeat; nausea; tightness in her throat; she couldn't breathe; Asthma attacks; There were a couple nights where she was wide awake for 24 hrs; She is being treated for a severe allergic reaction; her throat was paralyzed; she couldn't swallow; This is a spontaneous report from a contactable consumer (patient). A 59-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Right on 13Mar2021 (at the age of 59-years-old) (Batch/Lot Number: EM9809) as 0.3ML single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that the initial thing was about 30 minutes after the vaccine and she couldn't swallow, her throat was paralyzed. She was at the hospital for 4 hours. She had nausea and covid symptoms and tightness in her throat but it was not super severe. It didn't feel like she couldn't breathe. There were a couple nights where she was wide awake for 24 hrs. She stated at first it was manageable but as time went on it started getting stronger. She stated she had seen a doctor about this. The patient had the second dose of the vaccine on 13mar2021 and since then had been having asthma-like conditions. She was being treated for a severe allergic reaction. The patient has had tightness in her chest, kind of tingling in her shoulders and right arm and across her chest. She had a rapid heartbeat which she had no control over and it comes on and goes away. She was trying to see if there was a pattern but in the morning she had the sharp hot things through shoulder and back and that brings on tightness in her chest and then asthma and this follows the same pattern every 3 days. She stated she had 2 days of nothing and then the night before [before the third day] she had a rapid heartbeat and the next morning had the hot tingling things, and then an asthma attack. She asked what it is that she might be having an allergic reaction to? The patient stated she already had a list of ingredients. She stated she will reach out to her doctor to discuss this further. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: I am one of the 1% to contracted COVID; I am one of the 1% to contracted COVID; This is a spontaneous report from a contactable consumer (patient) forwarded as an adverse event by the Team. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCIN), 1st dose on an unspecified date as single dose, 2nd dose on an unspecified date as single dose; via an unspecified route of administration (Batch/Lot number was not reported) for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient reported that "I am one of the 1% to contracted COVID" on an unspecified date. The patient underwent lab tests and procedures which included COVID: contracted COVID on an unspecified date. The patient was one of the 1% to contracted COVID after being fully vaccinated with the Pfizer vaccine for over 6 weeks. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure diastolic, Blood pressure diastolic increased, Blood pressure systolic, Blood pressure systolic increased, Cough
Clinical narrative: runny nose; Lymph nodes in my left armpit are sore; diastolic blood pressure has gone up and it is now mostly around 100, and systolic ranges from 130 to 160; diastolic blood pressure has gone up and it is now mostly around 100, and systolic ranges from 130 to 160; I have been generally not feeling well compared to before the vaccination; cough; head congestion; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that a 51-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: 59267-1000-01/EW0161), via an unspecified route of administration in left arm on 19Apr2021 12:00 (at the age of 51-years-old) as single dose for COVID-19 immunisation at pharmacy or drug store. The patient's medical history and concomitant medications were not reported. The patient neither received other vaccine in four weeks nor other medications in two weeks. He had no known allergies. It was unknown if covid prior vaccination. Not tested covid post vaccination. It was unknown, if the patient was diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had been not tested for COVID-19. The device date was 02May2021. On 19Apr2021 12:00, the patient experiencing some health issues after taking the first dose of the Pfizer COVID-19 vaccine. Not sure if he should go for the second dose scheduled for 10May21. He took the first dose on 19Apr2021, since 19Apr2021 12:00 (then) he had been generally not feeling well compared to before the vaccination, did experience cough, head congestion, and runny nose. On 19-APR-2021 12:00, lymph nodes in his left armpit were sore, he was vaccinated in the left arm. It was getting better but not his normal self. Typically, when he was physically active his blood pressure stayed under control, but he noticed that his diastolic blood pressure had gone up and it was now mostly around 100, and systolic ranges from 130 to 160 (start date: 19-APR-2021 12:00) whenever he took readings at home after the vaccination. The patent had started taking AMLODIPINE 2.5MG tablet since 01May2021 but it was not helping much (corrective for blood pressure up). No treatment for all other events. The outcome for all the adverse events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Lymph node pain, Malaise, Rhinorrhoea
Clinical narrative: runny nose; Lymph nodes in my left armpit are sore; diastolic blood pressure has gone up and it is now mostly around 100, and systolic ranges from 130 to 160; diastolic blood pressure has gone up and it is now mostly around 100, and systolic ranges from 130 to 160; I have been generally not feeling well compared to before the vaccination; cough; head congestion; This is a spontaneous report from a contactable consumer. This consumer (patient) reported for himself that a 51-years-old male patient received first dose of BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, batch/lot number: 59267-1000-01/EW0161), via an unspecified route of administration in left arm on 19Apr2021 12:00 (at the age of 51-years-old) as single dose for COVID-19 immunisation at pharmacy or drug store. The patient's medical history and concomitant medications were not reported. The patient neither received other vaccine in four weeks nor other medications in two weeks. He had no known allergies. It was unknown if covid prior vaccination. Not tested covid post vaccination. It was unknown, if the patient was diagnosed with COVID-19 prior to vaccination and since the vaccination, the patient had been not tested for COVID-19. The device date was 02May2021. On 19Apr2021 12:00, the patient experiencing some health issues after taking the first dose of the Pfizer COVID-19 vaccine. Not sure if he should go for the second dose scheduled for 10May21. He took the first dose on 19Apr2021, since 19Apr2021 12:00 (then) he had been generally not feeling well compared to before the vaccination, did experience cough, head congestion, and runny nose. On 19-APR-2021 12:00, lymph nodes in his left armpit were sore, he was vaccinated in the left arm. It was getting better but not his normal self. Typically, when he was physically active his blood pressure stayed under control, but he noticed that his diastolic blood pressure had gone up and it was now mostly around 100, and systolic ranges from 130 to 160 (start date: 19-APR-2021 12:00) whenever he took readings at home after the vaccination. The patent had started taking AMLODIPINE 2.5MG tablet since 01May2021 but it was not helping much (corrective for blood pressure up). No treatment for all other events. The outcome for all the adverse events was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Intermenstrual bleeding
Clinical narrative: The first dose has brought my period on very early. My last cycle ended on 20Apr2021, seven days before the first dose. I started bleeding again on 30Apr2021.; This is a spontaneous report received from a contactable consumer(patient) reported that.   A 38-years-old female (Pregnant Not) patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EW0171), dose 1 via an unspecified route of administration, administered in Arm Left on 27Apr2021, (Age at vaccination:38 years)  as DOSE 1 SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient experienced the first dose has brought her period on very early her last cycle ended on 20Apr2021, seven days before the first dose she started bleeding again on 30Apr2021. The event outcome recovered on same day 30Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Dizziness, Dyspnoea, Fatigue, Feeling of body temperature change
Clinical narrative: arm sore (could not lift); tight shoulders; tight neck; fingers numb; fingers feel swollen; forearms heavy; dizzy; fatigued; unwell feeling; bright lights bother my eyes; achy bones; a little difficult breathing; I feel hot then cold back & forth; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received the second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EW0150) via intramuscular route of administration in right arm on 14Apr2021 at 7:45 am (at the age of 56 years old) as single dose, for COVID-19 immunization. The patient's medical history was not reported. Historical vaccine included the first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EN6207), via intramuscular route of administration in right arm on 24Mar2021 at 07:30 (at the age of 56 years old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any known allergies. Patient did not receive any other vaccines within 4 weeks. It was reported that on 24Apr2021 at 07:30 AM patient experienced arm sore (could not lift), tight shoulders, tight neck, fingers numb, fingers feel swollen, forearms heavy, dizzy fatigued, unwell feeling, bright lights bother his eyes, achy bones, a little difficult breathing, he was feeling hot then cold back & forth. The patient did not receive any treatment for the events. Outcome of the events was resolved on unspecified date.   Follow up attempts are needed. Further information is expected.  Follow-up (14Jun2021): New information reported from a contactable consumer includes: Aanatomical site of first and second dose injection updated from left arm to right arm, route of administration for both doses, date of the second vaccine dose and first dose changed from suspect dose to historical vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Joint stiffness, Limb discomfort, Malaise, Muscle tightness
Clinical narrative: arm sore (could not lift); tight shoulders; tight neck; fingers numb; fingers feel swollen; forearms heavy; dizzy; fatigued; unwell feeling; bright lights bother my eyes; achy bones; a little difficult breathing; I feel hot then cold back & forth; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received the second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EW0150) via intramuscular route of administration in right arm on 14Apr2021 at 7:45 am (at the age of 56 years old) as single dose, for COVID-19 immunization. The patient's medical history was not reported. Historical vaccine included the first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EN6207), via intramuscular route of administration in right arm on 24Mar2021 at 07:30 (at the age of 56 years old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any known allergies. Patient did not receive any other vaccines within 4 weeks. It was reported that on 24Apr2021 at 07:30 AM patient experienced arm sore (could not lift), tight shoulders, tight neck, fingers numb, fingers feel swollen, forearms heavy, dizzy fatigued, unwell feeling, bright lights bother his eyes, achy bones, a little difficult breathing, he was feeling hot then cold back & forth. The patient did not receive any treatment for the events. Outcome of the events was resolved on unspecified date.   Follow up attempts are needed. Further information is expected.  Follow-up (14Jun2021): New information reported from a contactable consumer includes: Aanatomical site of first and second dose injection updated from left arm to right arm, route of administration for both doses, date of the second vaccine dose and first dose changed from suspect dose to historical vaccine.  Follow-up attempts are completed. No further information is expected.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling, Photophobia
Clinical narrative: arm sore (could not lift); tight shoulders; tight neck; fingers numb; fingers feel swollen; forearms heavy; dizzy; fatigued; unwell feeling; bright lights bother my eyes; achy bones; a little difficult breathing; I feel hot then cold back & forth; This is a spontaneous report from a contactable consumer (patient). A 56-years-old male patient received the second dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EW0150) via intramuscular route of administration in right arm on 14Apr2021 at 7:45 am (at the age of 56 years old) as single dose, for COVID-19 immunization. The patient's medical history was not reported. Historical vaccine included the first dose of BNT162B2 (BNT162B2, PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: EN6207), via intramuscular route of administration in right arm on 24Mar2021 at 07:30 (at the age of 56 years old) as single dose for COVID-19 immunization. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not have any known allergies. Patient did not receive any other vaccines within 4 weeks. It was reported that on 24Apr2021 at 07:30 AM patient experienced arm sore (could not lift), tight shoulders, tight neck, fingers numb, fingers feel swollen, forearms heavy, dizzy fatigued, unwell feeling, bright lights bother his eyes, achy bones, a little difficult breathing, he was feeling hot then cold back & forth. The patient did not receive any treatment for the events. Outcome of the events was resolved on unspecified date.   Follow up attempts are needed. Further information is expected.  Follow-up (14Jun2021): New information reported from a contactable consumer includes: Aanatomical site of first and second dose injection updated from left arm to right arm, route of administration for both doses, date of the second vaccine dose and first dose changed from suspect dose to historical vaccine.  Follow-up attempts are completed. No further information is expected.