chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling, Urticaria
Clinical narrative: Itching all over/more itching/her palms of her hands are itching, both hands; Redness; Heat/warm patch area when it is flared up; It looked like hives with welts; It swells; her joints are stiff on both left and right hand; got kind of a little worse; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-year-old female patient received second dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: FA6780) via an unspecified route of administration, administered in arm right on 22Jul2021 (at the age of 48 years old) as dose 2, single for COVID-19 immunization. Medical history included brain operation from 2017 to an unknown date she had brain surgery in the past for cysts on her brain, the last was in 2017. There were no concomitant medications. The patient previously received first dose of bnt162b2 (BNT162B2, Solution for injection, Lot Number: ZW0187) via an unspecified route of administration, administered in arm right 01Jul2021 (at the age of 48 years old) as dose 1, single for COVID-19 immunization and within 1-2 days the patient experienced Itching and redness in different locations, like her shoulder, lower back, side, elbow, arm and rib cage and random patches of itching and redness in different locations. On an unspecified date in Jul2021, patient experienced itching all over/more itching/her palms of her hands are itching, both hands. On an unspecified date in 2021 patient experienced redness, heat/warm patch area when it is flared up, it looked like hives with welts, it swells, her joints are stiff on both left and right hand, after her second dose got kind of a little worse. The patient had calamine lotion as a therapeutic measure which helped with the itching. The outcome for the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Decreased appetite, Erythema, Headache, Hyperhidrosis, Lymphadenopathy
Clinical narrative: Swollen lymph nodes were obvious under breasts/inside of arms/arm pits both side and on top of rib cege/Swollen glonds/nodes were felt behind ears/on neck and around the top of my shoulders; left upper arm was sore and swollen; left upper arm was sore and swollen; shoulder to elbow raised and remained red and swollen for about 10 days; shoulder to elbow raised and remained red and swollen for about 10 days; Headache; sweats; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 44-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0186) via intramuscularly, administered in Arm Left on 30Jun2021 13:30 as DOSE 2 (age at the time of vaccination was 44-year-old), SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Hisorical vaccine included 1st Dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0173) via intramuscularly, administered in Arm Left on 08Jun2021 at 09:20 DOSE 2, SINGLE for COVID-19 immunisation and experienced event under Loss of taste and smell, Swollen bottom lips and cheeks, Sweats and headaches/migraine, Loss of appetite due to all food and liquids testing like salt or metal effects from first dose lasted 32 hours and then they stopped. On an unspecified date of 2021, the patient experienced swollen lymph nodes were obvious under breasts/inside of arms/arm pits both side and on top of rib cege/swollen glonds/nodes were felt behind ears/on neck and around the top of shoulders, left upper arm was sore and swollen, shoulder to elbow raised and remained red and swollen for about 10 days, headache, sweat and loss of appetite. Patient body appears back to its normal stages on the 27th/28th Jul2021. On an unspecified date in July 2021, the outcome of events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 44.0
Sex: U
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swollen lymph nodes were obvious under breasts/inside of arms/arm pits both side and on top of rib cege/Swollen glonds/nodes were felt behind ears/on neck and around the top of my shoulders; left upper arm was sore and swollen; left upper arm was sore and swollen; shoulder to elbow raised and remained red and swollen for about 10 days; shoulder to elbow raised and remained red and swollen for about 10 days; Headache; sweats; loss of appetite; This is a spontaneous report from a contactable consumer (patient). A 44-year-old patient of an unspecified gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0186) via intramuscularly, administered in Arm Left on 30Jun2021 13:30 as DOSE 2 (age at the time of vaccination was 44-year-old), SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Hisorical vaccine included 1st Dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0173) via intramuscularly, administered in Arm Left on 08Jun2021 at 09:20 DOSE 2, SINGLE for COVID-19 immunisation and experienced event under Loss of taste and smell, Swollen bottom lips and cheeks, Sweats and headaches/migraine, Loss of appetite due to all food and liquids testing like salt or metal effects from first dose lasted 32 hours and then they stopped. On an unspecified date of 2021, the patient experienced swollen lymph nodes were obvious under breasts/inside of arms/arm pits both side and on top of rib cege/swollen glonds/nodes were felt behind ears/on neck and around the top of shoulders, left upper arm was sore and swollen, shoulder to elbow raised and remained red and swollen for about 10 days, headache, sweat and loss of appetite. Patient body appears back to its normal stages on the 27th/28th Jul2021. On an unspecified date in July 2021, the outcome of events was recovered.  Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Condition aggravated
Clinical narrative: pain in my knee/I had the vaccine it intensified/it intensified the pain that I already had in my hip joint.; Condition aggregated; This is a spontaneous report from a contactable consumer or other non hcp.   A 65-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: FA6780, Expiry date: not reported), via an unspecified route of administration, administered in left arm on 25Jul2021 at 09:36 (Age at vaccination: 65 years old) as dose 1, single for covid-19 immunization. Medical history included: she already had the existing pain in her knee in her on the front of body above knee where the leg bones, hip bone she guessed she already had pain since an unknown date. She already had an injury where she fell on her right knee and had been in physical therapy for her left ankle for approximately about a month or month and half since an unknown date and when she fell not only she injured her left ankle but she also felt hard on her right knee so she had pain since, since then developing like over period of weeks problems with this right knee and also the same like hip joint. Concomitant medication(s) included quetiapine fumarate ER 125mg, bupropion hydrochloride 150 mg, quetiapine fumarate (SEROQUEL) and Alprazolam (expiry date: 14May2022), firstly taking higher but can't access it right now because she didn't have the right technology get with my doctor the other day. But she was supposed to take higher dosage, but she was taking three times a day half mg, medical cannabis and unspecified over the counter medications all for an unknown indication from an unknown date. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On the day of vaccination, 25Jul2021 evening, after she got the vaccine pain in my knee/I had the vaccine it intensified and there is no other explanation. It intensified the pain that I already had in my hip joint. She hasn't injured herself, she hasn't like nothing happened except for the vaccine. Regarding treatment, patient stated that she hasn't, she had requested two weeks ago she requested the name of orthopedic doctor from her health care provider who never called her back, so she called them and she got names and now have to make appointment to find out if they take her insurance from her health care company to give incorrect information. Outcome of events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: developed itching; rash; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 63-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EW0185) via an unspecified route of administration, administered in Arm Left on 26Jul2021 as DOSE 1, SINGLE for COVID-19 immunisation. Medical history included asthma from an unknown date and unknown if ongoing has had for the longest time, at least 10 years. The concomitant medications were not reported. On 30Jul2021 the patient developed itching and rash. Caller received her first dose of the Pfizer COVID-19 vaccine on 26July2021 and on Friday developed itching and a rash. Caller states she wants to know how to get rid of the itching, she is putting on lotion and it goes away for a little bit but comes back, it's in her hair, arms, legs, face. She scratches gets read, takes a shower with cold water and it goes away but comes back. Patient did not received any vaccine within 4 weeks. She went and got her first vaccine last Monday. She got a lot of itching and rash that started Friday. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: itchy; Hives; This is a spontaneous report from a contactable consumer or other non healthcare professional (patient). A 31-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: EW0198, Expiry date: unknown), via an unspecified route, administered in Arm Right on 25Jul2021 (at the age of 31-years-old) as DOSE 1, 0.3 ML SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Additional Vaccines Administered on Same Date of the Pfizer Suspect was reported as none. Patient's Medical History including any illness at time of vaccination none. Prior Vaccinations (within 4 weeks) was reported as none and Other Products was reported as no. Patient stated that she got the vaccine on 25Jul2021, her first dose and didn't have any side effects. About four days ago (31Jul2021) she got what looks like hives not under her armpit but part of her armpit and on her left and right hip. She clarified as the left side of her waist. Late afternoon 5:27 (on an unknown date) took a picture and texted her mom. She was wondering if it has been a week was that normal or concerning that she was having a reaction. It has not inhibited. It has just itchy (on an unknown date) and she puts aloe vera (treatment received for the events) on it. It has not caused pain just a little annoying. patient was not visited Emergency Room and Physician Office for the events. The outcome of event urticaria was not recovered and the other event was unknown.  Follow-up attempts are completed. No further information is expected
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Vaccination site bruising
Clinical narrative: She has experienced random numbness in her arm from the elbow down; She has 3 small black and blue marks on arm just below the injection site.; This is a spontaneous report from a contactable consumer or other non hcp. A 33-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: FA7848), dose 1 intramuscular, administered in Arm Left on 28Jul2021 (at the age of 33-years-old) as dose 1, single for covid-19 immunisation. The medical history included food allergy from an unknown date and unknown if ongoing (Allergy:Soy). The patient previously took yeast and experienced hypersensitivity and benzocaine and experienced drug hypersensitivity. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccine in four weeks of Covid-19 vaccine. The patient had other medications as oral contraceptive, in two weeks. The patient was not diagnosed with covid, prior vaccination. On 28Jul2021, the patient experienced random numbness in her arm from the elbow down and she has 3 small black and blue marks on arm just below the injection site. The patient was not tested for Covid, post vaccination. The outcome of the event she has experienced random numbness in her arm from the elbow down was recovered on 02Aug2021 and the other event was recovered on an unspecified date in 2021.  Follow-up attempts are completed. No further information is expected
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Decreased appetite, Fear, Feeling abnormal
Clinical narrative: Right Arm Pain at Injection site; whole body was pulsating; chest was super tight/chest tighten/chest tightness; lack of hunger; sinking feeling; heart speed up /heart is trying to pump really hard; like the feeling of the fear response feeling; chest pain on the left side of his chest and it radiated down his arm; stinging feeling of his stomach/was kind of painful/weird stinging feeling in the middle of his stomach,; chest was tight; This is a spontaneous report from a contactable consumer (patient).   A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FA7485, administered in Arm right on 27Jul2021 (at the age of 24-year-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. After first dose of vaccine patient experienced, chest pain on the left side of his chest and it radiated down his arm, stinging feeling of his stomach/was kind of painful/weird stinging feeling in the middle of his stomach, chest was tight, whole body was pulsating, chest was super tight/chest tighten/chest tightness, lack of hunger, sinking feeling, heart speed up /heart is trying to pump really hard, like the feeling of the fear response feeling. On 29Jul2021, patient experienced Right Arm Pain at Injection site. Treatment received for the event. The treatment was not reported for event like the feeling of the fear response feeling and others events the patient was received the treatment. On an unspecified date in 2021, lab data included, heart speed up /heart is trying to pump really hard. The Outcome of all events was not resolved.  Follow-Up (17Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate, Heart rate increased, Pain, Sensory disturbance, Vaccination site pain
Clinical narrative: Right Arm Pain at Injection site; whole body was pulsating; chest was super tight/chest tighten/chest tightness; lack of hunger; sinking feeling; heart speed up /heart is trying to pump really hard; like the feeling of the fear response feeling; chest pain on the left side of his chest and it radiated down his arm; stinging feeling of his stomach/was kind of painful/weird stinging feeling in the middle of his stomach,; chest was tight; This is a spontaneous report from a contactable consumer (patient).   A 24-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: FA7485, administered in Arm right on 27Jul2021 (at the age of 24-year-old) as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. After first dose of vaccine patient experienced, chest pain on the left side of his chest and it radiated down his arm, stinging feeling of his stomach/was kind of painful/weird stinging feeling in the middle of his stomach, chest was tight, whole body was pulsating, chest was super tight/chest tighten/chest tightness, lack of hunger, sinking feeling, heart speed up /heart is trying to pump really hard, like the feeling of the fear response feeling. On 29Jul2021, patient experienced Right Arm Pain at Injection site. Treatment received for the event. The treatment was not reported for event like the feeling of the fear response feeling and others events the patient was received the treatment. On an unspecified date in 2021, lab data included, heart speed up /heart is trying to pump really hard. The Outcome of all events was not resolved.  Follow-Up (17Aug2021): Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Feeling abnormal, Headache, Inflammation
Clinical narrative: thirsty a lot; feel a little bad; headaches; tiredness; inflammation to her hands and feet; chest pain; This is a spontaneous report from a contactable consumer (patient, reporting on herself) via medical information team. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0187 and expire Date: Unknown), via unspecified route of administration, in Arm Left, on 23July2021 (age at vaccination: 45 years), as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. patient did not provided family medical history relevant to adverse events. The patient did not receive any vaccines administered on same date with the Pfizer vaccine considered as suspect. The patient did not receive any vaccines within four weeks prior to the first administration date of the suspect vaccine. patient did not have any relevant tests results.On 23July2021 patient experienced headaches, tiredness, inflammation to her hands and feet, chest pain. on unspecified date she was thirsty a lot. she wants to know if her symptoms were normal, what she could do about the side effect and how long will they last. she felt a little bad and her primary healthcare professional is not available until september. The seriousness of the events was Unspecified. Outcome of the events headaches, tiredness, inflammation to her hands and feet, chest pain was not resolved and outcome of the event thirsty a lot, felt a little bad was unknown  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: thirsty a lot; feel a little bad; headaches; tiredness; inflammation to her hands and feet; chest pain; This is a spontaneous report from a contactable consumer (patient, reporting on herself) via medical information team. A 45-years-old female patient received BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EW0187 and expire Date: Unknown), via unspecified route of administration, in Arm Left, on 23July2021 (age at vaccination: 45 years), as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. patient did not provided family medical history relevant to adverse events. The patient did not receive any vaccines administered on same date with the Pfizer vaccine considered as suspect. The patient did not receive any vaccines within four weeks prior to the first administration date of the suspect vaccine. patient did not have any relevant tests results.On 23July2021 patient experienced headaches, tiredness, inflammation to her hands and feet, chest pain. on unspecified date she was thirsty a lot. she wants to know if her symptoms were normal, what she could do about the side effect and how long will they last. she felt a little bad and her primary healthcare professional is not available until september. The seriousness of the events was Unspecified. Outcome of the events headaches, tiredness, inflammation to her hands and feet, chest pain was not resolved and outcome of the event thirsty a lot, felt a little bad was unknown  Follow-up attempts are completed. No further information is expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Asthma, Dyspnoea, Fatigue
Clinical narrative: arm swelling; Asthma; Slight difficulty breathing; wheezing; feeling weak; Injection site pain; Site swelling; injection site redness; extreme tiredness; headache; muscle pain; joint pain; nausea; feeling unwell; itching; arm pain; This is a spontaneous report from a contactable nurse or other health care professional (patient) reported for himself. A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: FA7484; Expiration date: not provided) via an unspecified route of administration on 02Aug2021 left arm at 16:00 in left arm as dose 1, single for Covid-19 immunization at pharmacy/drug store facility. Medical history included known allergies: penicillin and no asthma incidents for several months prior to injection from an unknown date and unknown if ongoing. Other medical history was reported as none. Patient received other medications within two weeks of vaccination as concomitant medications included tamsulosin hydrochloride (FLOMAX (TAMSULOSIN HYDROCHLORIDE)); atorvastatin (ATORVASTATIN); fish oil (FISH OIL); VIT D (VITAMIN D NOS) and multivitamin all were taken for an unspecified indication, start and stop date 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 vaccines within four weeks prior to the vaccination. On 02Aug2021 17:00, patient experienced injection site pain, extreme tiredness, headache, muscle pain, joint pain, injection site redness, site swelling, arm swelling, nausea, arm pain, feeling weak and unwell, itching, asthma, slight difficulty breathing and wheezing. Therapeutic measures were reported as yes for event asthma, because he was now using his asthma albuterol inhaler and there were no asthma incidents for several months prior to injection, while for all other events reported as no. The outcome of the events was reported as not recovered.  Follow-up attempts are completed. No further information expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Malaise, Myalgia, Nausea, Pain in extremity
Clinical narrative: arm swelling; Asthma; Slight difficulty breathing; wheezing; feeling weak; Injection site pain; Site swelling; injection site redness; extreme tiredness; headache; muscle pain; joint pain; nausea; feeling unwell; itching; arm pain; This is a spontaneous report from a contactable nurse or other health care professional (patient) reported for himself. A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: FA7484; Expiration date: not provided) via an unspecified route of administration on 02Aug2021 left arm at 16:00 in left arm as dose 1, single for Covid-19 immunization at pharmacy/drug store facility. Medical history included known allergies: penicillin and no asthma incidents for several months prior to injection from an unknown date and unknown if ongoing. Other medical history was reported as none. Patient received other medications within two weeks of vaccination as concomitant medications included tamsulosin hydrochloride (FLOMAX (TAMSULOSIN HYDROCHLORIDE)); atorvastatin (ATORVASTATIN); fish oil (FISH OIL); VIT D (VITAMIN D NOS) and multivitamin all were taken for an unspecified indication, start and stop date 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 vaccines within four weeks prior to the vaccination. On 02Aug2021 17:00, patient experienced injection site pain, extreme tiredness, headache, muscle pain, joint pain, injection site redness, site swelling, arm swelling, nausea, arm pain, feeling weak and unwell, itching, asthma, slight difficulty breathing and wheezing. Therapeutic measures were reported as yes for event asthma, because he was now using his asthma albuterol inhaler and there were no asthma incidents for several months prior to injection, while for all other events reported as no. The outcome of the events was reported as not recovered.  Follow-up attempts are completed. No further information expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: arm swelling; Asthma; Slight difficulty breathing; wheezing; feeling weak; Injection site pain; Site swelling; injection site redness; extreme tiredness; headache; muscle pain; joint pain; nausea; feeling unwell; itching; arm pain; This is a spontaneous report from a contactable nurse or other health care professional (patient) reported for himself. A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: FA7484; Expiration date: not provided) via an unspecified route of administration on 02Aug2021 left arm at 16:00 in left arm as dose 1, single for Covid-19 immunization at pharmacy/drug store facility. Medical history included known allergies: penicillin and no asthma incidents for several months prior to injection from an unknown date and unknown if ongoing. Other medical history was reported as none. Patient received other medications within two weeks of vaccination as concomitant medications included tamsulosin hydrochloride (FLOMAX (TAMSULOSIN HYDROCHLORIDE)); atorvastatin (ATORVASTATIN); fish oil (FISH OIL); VIT D (VITAMIN D NOS) and multivitamin all were taken for an unspecified indication, start and stop date 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 vaccines within four weeks prior to the vaccination. On 02Aug2021 17:00, patient experienced injection site pain, extreme tiredness, headache, muscle pain, joint pain, injection site redness, site swelling, arm swelling, nausea, arm pain, feeling weak and unwell, itching, asthma, slight difficulty breathing and wheezing. Therapeutic measures were reported as yes for event asthma, because he was now using his asthma albuterol inhaler and there were no asthma incidents for several months prior to injection, while for all other events reported as no. The outcome of the events was reported as not recovered.  Follow-up attempts are completed. No further information expected.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Wheezing
Clinical narrative: arm swelling; Asthma; Slight difficulty breathing; wheezing; feeling weak; Injection site pain; Site swelling; injection site redness; extreme tiredness; headache; muscle pain; joint pain; nausea; feeling unwell; itching; arm pain; This is a spontaneous report from a contactable nurse or other health care professional (patient) reported for himself. A 69-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot number: FA7484; Expiration date: not provided) via an unspecified route of administration on 02Aug2021 left arm at 16:00 in left arm as dose 1, single for Covid-19 immunization at pharmacy/drug store facility. Medical history included known allergies: penicillin and no asthma incidents for several months prior to injection from an unknown date and unknown if ongoing. Other medical history was reported as none. Patient received other medications within two weeks of vaccination as concomitant medications included tamsulosin hydrochloride (FLOMAX (TAMSULOSIN HYDROCHLORIDE)); atorvastatin (ATORVASTATIN); fish oil (FISH OIL); VIT D (VITAMIN D NOS) and multivitamin all were taken for an unspecified indication, start and stop date 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 vaccines within four weeks prior to the vaccination. On 02Aug2021 17:00, patient experienced injection site pain, extreme tiredness, headache, muscle pain, joint pain, injection site redness, site swelling, arm swelling, nausea, arm pain, feeling weak and unwell, itching, asthma, slight difficulty breathing and wheezing. Therapeutic measures were reported as yes for event asthma, because he was now using his asthma albuterol inhaler and there were no asthma incidents for several months prior to injection, while for all other events reported as no. The outcome of the events was reported as not recovered.  Follow-up attempts are completed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast swelling, Depression, Heavy menstrual bleeding, Polymenorrhoea
Clinical narrative: Periodic sense of dread/depression not ever experienced previously. All continuing symptoms are hormonal based; ongoing breast swelling; breast soreness (very painful); menstrual cycle is now every 20/21 days vs. 28-30 days and heavier than before vaccination.; menstrual cycle is now every 20/21 days vs. 28-30 days and heavier than before vaccination.; This is a spontaneous report from a contactable consumer (patient). A 43-year-old non-pregnant female patient received BNT162B2 (COMIRNATY, Solution for injection) first dose via unspecified route in left arm on 09Apr2021 (Lot Number: EW0150) (at the age of 43-year-old) as DOSE 1, SINGLE, for covid-19 immunization and second dose via unspecified route in right arm on 30Apr2021 (Lot Number: EW0176) (at the age of 43-year-old) as DOSE 2, SINGLE for covid-19 immunization. Facility type vaccine reported as other. The patient medical history was none reported. The patient did not have any concomitant medications. The patient did not have any known allergies. No covid prior vaccination. No covid tested post vaccination. The patient did not receive any other vaccines within four weeks. No other medications in two weeks. On 16Apr2021, patient experienced ongoing breast swelling, breast soreness (very painful), menstrual cycle is now every 20/21 days vs. 28-30 days and heavier than before vaccination, Periodic sense of dread/depression not ever experienced previously. All continuing symptoms are hormonal based. No treatment received for the event. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Myalgia, Paraesthesia
Clinical narrative: now having numbness and constant tingling that worsens with movement that goes from her left shoulder all the way down to her fingers/fingers and wrist are tingly and numb; now having numbness and constant tingling that worsens with movement that goes from her left shoulder all the way down to her fingers/fingers and wrist are tingly and numb; can barely lift her left arm over her head due to muscle and joint pain; can barely lift her left arm over her head due to muscle and joint pain; This is a spontaneous report from a contactable Consumer (patient). A 62-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: FA7484) via an unspecified route of administration, administered in arm left on 03Aug2021 15:30 (at the age of 62-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient had a medical history of a birth defect in her elbow and about 20 years ago had a surgery where her nerve and muscle were moved around her left elbow. The patient had surgery like 20+ years ago to move a nerve and muscles in her arm. The patient always had nerve issues in the muscle in the arm. Concomitant medications were not reported. The patient did not have history of all previous immunization with the Pfizer vaccine. No additional vaccines administered on same date of the Pfizer suspect. No prior Vaccinations within four weeks prior to the first administration date of the suspect vaccine. No adverse event following prior vaccinations. On 03Aug2021, the patient stated that she was now having numbness and constant tingling that worsens with movement that goes from her left shoulder all the way down to her fingers and can barely lift her left arm over her head due to muscle and joint pain. Tingling and numbness are going into her wrist, thumb, pinky. The patient got the shot on 03Aug2021, the first one and asking was it common for her to have tingling and numbness in her whole arm, she knows it was put into the muscle. Tingling and numbness started as soon as she got the shot, around 3:30PM on 03 Aug 2021. She always had nerve issues in the muscle in the arm, she was wondering if this was going to take a long time to get rid of and she can barely lift her arm over head, fingers and wrist are tingly and numb, she just could not explain the sensation. The patient reported that it depends on how much she tried to move her arm of how much tingling and numbness she gets, If she tried to put her arm straight, its worst, going into wrist, thumb, pinky. The patient confirmed that it began as soon as she got the shot on 03Aug2021. Adverse event did not require visit to emergency room and physician office. The outcome of events was not recovered. The events were reported as non-serious.  Follow-up attempts are completed. No further information was expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Gait inability, Rash, Tremor
Clinical narrative: Shaking so much; Diarrhea; Rash; Unable to stand or walk; It also made him weak; This is a spontaneous report from a contactable consumer. This consumer re-ported for a 82-year-old male patient (reporter's husband) received second dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EM9809 and expiry date: 01Jun2021), via an unspecified route of administration, in Arm Right, on 12Feb2021 (age at vaccination: 82 years), as dose 2, single dose for COVID-19 immunization. Vaccine was not administered at military facility. The patient's medical history included ongoing Diabetic (he was diagnosed in his 40s, Has had for years, takes medications for diabetes constantly). Concomitant medications were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number: EL9262 and expiry date: 01May2021), via an unspecified route of administration, in Arm Right, on 22Jan2021 (age at vaccination: 82 years), as dose 1, single dose for COVID-19 immunization. The reporter was calling to report something for her husband (patient). The patient had severe shaking, it was with his nervous system. He also had diarrhea. The patient was shaking so much he was unable to stand or walk. It also made him weak on an unspecified date in Feb2021. They had no idea what it was. It went away as fast it came. It was not lasting. The patient also had a rash on the back which was something that had never occurred before. Shaking so much was a week after the last vaccination. The patient received the second dose 12Feb2021. At first they did not think it was all connected until told family of nurses who were familiar with the reaction. They told reporter (patient's wife) to report this to (Withheld). She tried to report to (Withheld), but they did not seem worried about it. She was calling us because she thought someone should know about it. She thought if more than one person had this reaction most likely a side effect and should be aware. The shaking so much lasted about 4-5 hours at a severe state. Then it got better, but it took close to 3-4 days for it to completely go away. However, after the shaking so much episodes the patient was extremely weak after that. He still has not gained his strength back. Diarrhea was began within ten minutes after the shaking started. It stopped within three days Rash was on his back and it started within a week of the second shot. It was all happening at the same time. Unable to clarify statement further. The adverse events did not require a visit to emergency room and physician office. The patient did not receive any vaccine prior vaccinations (within 4 weeks). The patient did not go to the Emergency Room or see a doctor about this. Outcome of the events shaking so much and diarrhea was recovered on an unspecified date in Feb2021, rash and unable to stand or walk was unknown and it also made him weak was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Low grade fever; This is a spontaneous report from a contactable consumer or other non hcp (patient's grandmother). A 14-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: FA7485, Expiration date: Unknown) via unspecified route of administration on 05Aug2021 as dose 2, single (at the age of 14-year-old) for COVID-19 immunization. Medical history included growth hormone therapy from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient had no prior vaccinations within four weeks. The patient previously received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot Number: unknown, Expiration date: Unknown) via unspecified route of administration on 14Jul2021 as dose 1, single (at the age of 14-year-old) for COVID-19 immunization and experienced low grade fever. On 05Aug2021, the patient experienced low grade fever. Patient was not received any treatment. On 05Aug2021, the patient underwent lab tests and procedures which included pyrexia as 99 (he started fever about 99). The outcome of the event was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; she is feeling kind of sweaty; This is a spontaneous report from a contactable consumer (patient's mother). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in Arm Left on 06Aug2021 (at the age 15-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA6780), via an unspecified route of administration, administered in Arm Left on 16Jul2021 (at the age 15-years-old) as dose 1, single for COVID-19 immunisation. There was no prior vaccination. The patient experienced tiredness, headache, muscle pain, chills, joint pain, fever and she was feeling kind of sweaty on an unspecified date in Aug2021. Consumer reported that they got their daughter her second shot yesterday morning and she was 15 almost, she would be 16 next month and she didn't have any issues with the first one and she thought this maybe normal but she just felt better if he check to know when its your child. She was suffering from some of those side effects from the paperwork like the tiredness, the headache, the muscle pain, the chills, joint pain, the fever. her husband didn't get a new battery for thermometer, so she couldn't tell exactly what her fever was but she thought its breaking because she was feeling kind of sweaty now (further clarification unknown). But she gave her a couple of Ibuprofen (treatment) to help with the aches and the fever. Reporter guesses that she would have to watch her closely or call her physician or the pharmacy where she got her. Reporter stated, she gave her Ibuprofen and plenty of fluids. It was Ibuprofen, she gave her two 200 mg tablets, so, it would be 400 mg, each capsule was 200 mg, so it would have been a total of 400 and she said that she took 3 of them last night and she did not know that (further clarification about dose of Ibuprofen was unknown). Reporter was advised to call withheld or visit nearest ER in case of any emergency. The patient underwent lab tests and procedures which included body temperature: unknown result (Fever) on an unknown date of 2021. Therapeutic measures were taken as a result of all the events included Ibuprofen (two 200 mg tablets) and plenty of fluids. The clinical outcome of all the events were unknown.  Follow-up attempts are completed. No further information is expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Tiredness; Headache; Muscle pain; Chills; Joint pain; Fever; she is feeling kind of sweaty; This is a spontaneous report from a contactable consumer (patient's mother). A 15-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA7485), via an unspecified route of administration, administered in Arm Left on 06Aug2021 (at the age 15-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: FA6780), via an unspecified route of administration, administered in Arm Left on 16Jul2021 (at the age 15-years-old) as dose 1, single for COVID-19 immunisation. There was no prior vaccination. The patient experienced tiredness, headache, muscle pain, chills, joint pain, fever and she was feeling kind of sweaty on an unspecified date in Aug2021. Consumer reported that they got their daughter her second shot yesterday morning and she was 15 almost, she would be 16 next month and she didn't have any issues with the first one and she thought this maybe normal but she just felt better if he check to know when its your child. She was suffering from some of those side effects from the paperwork like the tiredness, the headache, the muscle pain, the chills, joint pain, the fever. her husband didn't get a new battery for thermometer, so she couldn't tell exactly what her fever was but she thought its breaking because she was feeling kind of sweaty now (further clarification unknown). But she gave her a couple of Ibuprofen (treatment) to help with the aches and the fever. Reporter guesses that she would have to watch her closely or call her physician or the pharmacy where she got her. Reporter stated, she gave her Ibuprofen and plenty of fluids. It was Ibuprofen, she gave her two 200 mg tablets, so, it would be 400 mg, each capsule was 200 mg, so it would have been a total of 400 and she said that she took 3 of them last night and she did not know that (further clarification about dose of Ibuprofen was unknown). Reporter was advised to call withheld or visit nearest ER in case of any emergency. The patient underwent lab tests and procedures which included body temperature: unknown result (Fever) on an unknown date of 2021. Therapeutic measures were taken as a result of all the events included Ibuprofen (two 200 mg tablets) and plenty of fluids. The clinical outcome of all the events were unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Feels like having a fever; I have fever; I don't feel good; This is a spontaneous report from a Pfizer-sponsored program. A non-contactable female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number and Expiration date were not reported) via an unspecified route of administration, on 05Aug2021 as dose number unknown, single for COVID-19 immunization. The patient relevant medical history and concomitant medication(s) were not reported. Patient concern was that she received the Pfizer COVID 19 Vaccine this morning and she felt like having a fever she wanted to know if she could take Tylenol or Advil?" When para-phrased the concern, patient stated, "Yes, her question was in the (withheld) they said that you could take Tylenol, unfortunately she didn't have Tylenol at home she have Advil. She didn't know it was safe to take Advil or not, She have to take specifically take only Tylenol." Patient stated, "Now she have fever and she didn't feel good until tomorrow was 10 hours. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Chills, Dyspnoea, Fatigue
Clinical narrative: Shortness of breathe/S.O.B when lying down; feeling irregular heart rhythms; chest pain; chest pressure; migraine; feeling warm; arm pain; muscle pain; shivering/chills; fatigue; swollen at injection site; pain and swollen at injection site; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 21-years-old female patient (patient was not pregnant at the time of vaccination) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: FA7484, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 01Aug2021 at 12:00 pm (age at vaccination was 21 years) as dose 2, single for COVID-19 immunization. The patient's medical history included scoliosis. The patient did not have any known allergies. Concomitant medications or other medications the patient received in two weeks included melatonin and citrus aurantium, crataegus monogyna fruit, cymbopogon citratus, matricaria recutita flower, mentha spicata leaf, rosa x centifolia, rubus fruticosus leaf, tilia spp. flower (SLEEPYTIME HERB) (sleepytime tea) both taken for an unspecified indication. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0198, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 11Jul2021 (age at vaccination was 21 years) as dose 1, single for COVID-19 immunization. The facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 01Aug2021 at 14:45 pm, the patient experienced feeling warm, shivering/chills, migraine, chest pressure, chest pain, shortness of breathe/S.O.B when lying down, feeling irregular heart rhythms, fatigue, pain and swollen at injection site, muscle pain and arm pain. No treatment was received for the adverse events. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.