chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Having sore throat for last 24 hours and wondering to get the second dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 2021, outcome "unknown", described as "Having sore throat for last 24 hours and wondering to get the second dose".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Vaccination site pain
Clinical narrative: Blisters; pain in the area of the shoulder on the area of the shoulder of the arm that I received this shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administration date 08May2021 (Batch/Lot number: unknown) at the age of 47 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure. Concomitant medication(s) included: AMLODIPINE taken for blood pressure measurement. The following information was reported: BLISTER (non-serious), outcome "unknown", described as "Blisters"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain in the area of the shoulder on the area of the shoulder of the arm that I received this shot". Therapeutic measures were taken as a result of vaccination site pain.  Additional Information: Patient stated, Yesterday he had taken the Pfizer vaccine shot, wich was the first one, he had taken  yesterday (confirmed as 8May2021) and today, patient had experienced pain in the area of the shoulder on the area of the shoulder of the arm that he had received vaccine shot, but he had blister afternoon ago but he was just wondering if that was normal to have blister in all the area also too." Patient stated, "No, well the pain was diminished a little bit because  he had taken a Tylenol for pain, extra strength Tylenol, and yes some of the pain got diminished,  as he was in pain so  had taken a pill for pain."  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 29.0
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: tingling feeling in my buttock; leg kind of got sore; arm soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 29-year-old patient received bnt162b2 (BNT162B2) (Lot number: EW0173, Expiration Date: Aug2021) at the age of 29 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "acne" (unspecified if ongoing); "Birth control" (unspecified if ongoing). Concomitant medication(s) included: SPIRONOLACTONE taken for acne (ongoing); LOESTRIN taken for contraception (ongoing). Past drug history included: Amox-clav, notes: I was taking it once in the morning and once in the evening. I am not on it anymore I just took it for only 5 days prior to the vaccine. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "tingling feeling in my buttock"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "leg kind of got sore"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm soreness". Therapeutic measures were taken as a result of pain in extremity.  Additional information: The patient got the first dose of the Pfizer vaccine yesterday morning and didn't have the arm soreness until last night but it did start probably like 30 minutes after vaccine administered and had like tingling feeling in the buttock and throughout the day, the patient's leg kind of got sore and didn't know it sounds like a normal thing because it was on the same side of the body of the vaccine like where patient got the shot. The patient took Tylenol and then also just got off antibiotic like a day before the vaccine, but the patient was clear that would be ok to take the vaccine could give the name of the antibiotic too. So the abbreviation is Amoxicillin, Amox-clav. The patient was taking it once in the morning and once in the evening and that was for what the patient thought was a reoccurring cyst. The patient was not on that anymore although. It was Amoxicillin and then it was Amoxycillin/Clavulanic acid. The patient was not on it anymore and just took it for only 5 days prior to the vaccine. The patient received another prescription medicine too that was on and off. The patient took Valacyclovir. It's not every day, that the patient took it. It was a Herpes simplex virus pill. HSV-2.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed, Ovulation delayed
Clinical narrative: After 1st dose, delayed ovulation and period by 1 week; After 1st dose, delayed ovulation and period by 1 week; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 05Apr2021 (Batch/Lot number: unknown) at the age of 27 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: OVULATION DELAYED (non-serious), MENSTRUATION DELAYED (non-serious) all with onset 30Apr2021, outcome "recovered" (2021) and all described as "After 1st dose, delayed ovulation and period by 1 week". Therapeutic measures were not taken as a result of ovulation delayed, menstruation delayed.  Additional information: The Lot unknown reason was unable to locate or read the details. The facility type vaccine was school or student health clinic. No vaccine was administered to patient in four weeks. Patient did not take any other medications in two weeks. After 1st dose, delayed ovulation and period by 1 week. No change to daily routine. Patient did not have Covid prior and post vaccination. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Goitre, Illness
Clinical narrative: Thyroid glands, that is been swollen; I am sick; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: GOITRE (non-serious), outcome "not recovered", described as "Thyroid glands, that is been swollen"; ILLNESS (non-serious), outcome "unknown", described as "I am sick".  Additional information: Patient was  calling regarding the swollen glands, side effects. Patient had her/his thyroid glands, that was been swollen for 2 days and this does not seem to go away.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: left side aches; Swollen lymph nodes; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 27 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 (Batch/Lot number: unknown) at the age of 27 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose number=1, date=05Apr2021), administration date: 05Apr2021, when the patient was 27 years old, for Covid-19 Immunisation, reaction(s): "Ovulation delayed". The following information was reported: PAIN (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "left side aches"; LYMPHADENOPATHY (non-serious) with onset 30Apr2021, outcome "recovered" (2021), described as "Swollen lymph nodes". Therapeutic measures were not taken as a result of pain, lymphadenopathy.  Additional information: Swollen lymph nodes and left side aches 12 hours after 2 nd dose. After 1st dose, delayed ovulation and period by 1 week. No change to daily routine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. Patient had no known allergies. There were no other vaccines administered in four weeks and no other medications taken in two weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 30 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 24Apr2021 08:00 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Dandelions allergy" (unspecified if ongoing), notes: Dandelions allergy; "Shrimp" (unspecified if ongoing), notes: Shrimp. There were no concomitant medications. The following information was reported: DIZZINESS (non-serious) with onset 02May2021 07:00, outcome "not recovered", described as "Dizziness". Therapeutic measures were not taken as a result of dizziness.  Additional information: Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient didn't take any other medication in two weeks. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Peripheral swelling
Clinical narrative: Headache; Swelling in my arm; Some fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "Headache"; PERIPHERAL SWELLING (non-serious), outcome "recovered", described as "Swelling in my arm"; FATIGUE (non-serious), outcome "recovered", described as "Some fatigue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Gastrointestinal disorder, Parosmia, SARS-CoV-2 test negative
Clinical narrative: GI issues; an unusual smell (off and on); This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 37-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Apr2021 15:00 (Lot number: EW0171) at the age of 37 years as dose 2, single for covid-19 immunization. Relevant medical history included: "Some chronic GI issues" (unspecified if ongoing), notes: Some chronic GI issues, nothing formally diagnosed. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (lot number=ER8732, administration date=31Mar2021, administration time=02:00 PM, dose number=1, vaccine location=Left arm), administration date: 31Mar2021, when the patient was 36 years old, for COVID-19 immunization, reaction(s): "Within 8 hours of the first dose I experience GI issues loss of appetite lasting about 5 days.", "Within 8 hours of the first dose I experience GI issues loss of appetite lasting about 5 days.". The following information was reported: GASTROINTESTINAL DISORDER (non-serious) with onset 2021, outcome "recovering", described as "GI issues"; PAROSMIA (non-serious) with onset 2021, outcome "recovering", described as "an unusual smell (off and on)". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of gastrointestinal disorder, parosmia.  Additional information: The patient did not receive any other vaccine in four weeks of covid vaccine. The patient received other medications in two weeks. The patient was neither diagnosed with covid prior vaccination. The patient got tested for covid post vaccination. The patient has no known allergies. Within 6 days of the 2nd dose, the patient experienced GI issues lasting 4 days and still ongoing. Also, have experienced an unusual smell (off and on) during the same time frame. Events were recovering.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune hepatitis, Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, chills, body aches, headache x 36 hours. Onset of autoimmune hepatitis on 1/24/22. I was told to report this to VAERS.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Upper respiratory tract infection
Clinical narrative: Fever, chills, body aches, headache x 36 hours. Onset of autoimmune hepatitis on 1/24/22. I was told to report this to VAERS.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Hyperhidrosis, Immediate post-injection reaction, Nausea
Clinical narrative: Patient lost color in his face and felt very dizzy/lightheaded immediately following vaccination. Patient displayed symptoms of sweating and physical chills. He also complained of slight nausea intermittently.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pallor
Clinical narrative: Patient lost color in his face and felt very dizzy/lightheaded immediately following vaccination. Patient displayed symptoms of sweating and physical chills. He also complained of slight nausea intermittently.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity
Clinical narrative: HEADACHE. FATIGUE. ARM PAIN
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Anxiety, Biopsy skin, Fatigue, Feeling abnormal
Clinical narrative: High Fever, body aches, fatigue, headache.  extreme hair loss, mental fog, anxiety
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Full blood count, Headache, Pain, Pyrexia
Clinical narrative: High Fever, body aches, fatigue, headache.  extreme hair loss, mental fog, anxiety
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Severe tinnitus in both ears.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Chills, Discomfort, Dizziness, Headache
Clinical narrative: Janssen COVID-19 Vaccine EUA From the time I was given the vaccine, I have had pressure on the left side of my chest, including my left arm pit, left side of clavicle, left breast, and throat.  I've had dizziness, chills, and a headache.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Breast discomfort, Chest discomfort, Chills, Dizziness
Clinical narrative: Janssen COVID-19 Vaccine EUA From the time I was given the vaccine, I have had pressure on the left side of my chest, including my left arm pit, left side of clavicle, left breast, and throat.  I've had dizziness, chills, and a headache.
Age: 4.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Limb discomfort, Oropharyngeal discomfort
Clinical narrative: Janssen COVID-19 Vaccine EUA From the time I was given the vaccine, I have had pressure on the left side of my chest, including my left arm pit, left side of clavicle, left breast, and throat.  I've had dizziness, chills, and a headache.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Nausea; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 06May2021 (Lot number: EW0171) at the age of 63 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (ongoing), notes: States she was diagnosed 7 years ago. . Concomitant medication(s) included: BABY ASPIRIN taken for hypertension. The following information was reported: NAUSEA (non-serious) with onset 06May2021, outcome "unknown", described as "Nausea".  Additional Information: The patient stated for concomitant Product baby aspirin she did not took one every day, she just took it sometimes. She did not had high blood pressure all the time. She stated there was times it flares up. concomitant Products baby aspirin took for blood pressure. she called because she got her first dose of the COVID-19 vaccine yesterday and had nausea on and off since then. The caller was wondering how long the nausea would last and when could she take aspirin again. she was wondering when she could take anything over the counter medications or her prescription medication she had for nausea. She stated she had Reglan and Zofran and wanted to know if she could take any of those. Caller stated that the nausea started around 5 or 6 pm on the 06May2016 and had experienced it off and on since then. She stated that when she first made this phone call, she was experiencing nausea and now she was not. She states that she had a prescription medication for it and wanted to know if she could take it and when could she start taking aspirin again for her blood pressure. She stated that she takes the low dose aspirin from time to time. She also wanted to know if there were any other products she shouldn't be taking, because she did not want to decrease the effectiveness of the vaccination. she stated that she could not take a narcotic medication. No prior vaccination within 4 weeks No AE(s) following prior vaccinations.  No follow-up attempts are possible. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chills, Decreased appetite, Diarrhoea, Fatigue
Clinical narrative: Muscle pain, lymph node swelling/pain, back pain, neck pain, neck muscles shortened (I was stuck looking at the ceiling), headache, nausea, loss of appetite, vomiting, diarrhea, runny nose, sinus congestion, fatigue, insomnia, severe chills and hot flashes.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hot flush, Insomnia, Lymph node pain, Lymphadenopathy
Clinical narrative: Muscle pain, lymph node swelling/pain, back pain, neck pain, neck muscles shortened (I was stuck looking at the ceiling), headache, nausea, loss of appetite, vomiting, diarrhea, runny nose, sinus congestion, fatigue, insomnia, severe chills and hot flashes.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle contracture, Myalgia, Nausea, Neck pain, Rhinorrhoea
Clinical narrative: Muscle pain, lymph node swelling/pain, back pain, neck pain, neck muscles shortened (I was stuck looking at the ceiling), headache, nausea, loss of appetite, vomiting, diarrhea, runny nose, sinus congestion, fatigue, insomnia, severe chills and hot flashes.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Sinus congestion, Vomiting
Clinical narrative: Muscle pain, lymph node swelling/pain, back pain, neck pain, neck muscles shortened (I was stuck looking at the ceiling), headache, nausea, loss of appetite, vomiting, diarrhea, runny nose, sinus congestion, fatigue, insomnia, severe chills and hot flashes.
Age: 92.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fall
Clinical narrative: Patient presented to the ED on 10/22 following a fall at home. Prior to ED, patient was very weak and family was worried about a stroke. Patient was fully vaccinated with Pfizer vaccinations on 1/27, 2/16, and 10/21. Further workup warranted. Patient was admitted 10/22/21 and discharged 11/2/21.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chest pain, Diarrhoea, Headache, Myalgia
Clinical narrative: Chest pain, heart palpitations, crippling joint pain, muscle pain and daily fever (from 103.5 first 3 days to 101 daily since). Headaches won't go away even with Imitrex. Diarrhea. No treatments given. I'm scheduled for blood work and EKG next week. I was told to go to hospital if it escalates prior to my appointment. My rheumatologist was upset I got the vaccine, because I am so sensitive to all vaccines. I had COVID-19 1 month ago. PCP didn't want me to get booster. As of today, I received the vaccination. I had to decide between this outcome or losing my job. Now vaccination not mandated. And now I'm ignored because it's just a side effect.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia
Clinical narrative: Chest pain, heart palpitations, crippling joint pain, muscle pain and daily fever (from 103.5 first 3 days to 101 daily since). Headaches won't go away even with Imitrex. Diarrhea. No treatments given. I'm scheduled for blood work and EKG next week. I was told to go to hospital if it escalates prior to my appointment. My rheumatologist was upset I got the vaccine, because I am so sensitive to all vaccines. I had COVID-19 1 month ago. PCP didn't want me to get booster. As of today, I received the vaccination. I had to decide between this outcome or losing my job. Now vaccination not mandated. And now I'm ignored because it's just a side effect.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Death
Clinical narrative: Hospitalized with COVID while fully vaccinated. Patient expired from COViD
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: The vaccine was given one day past the beyond use date. no reactions reported by patient
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: patient received moderna dose  #1 - 9/21/22 at another location and then given pfizer as their second dose in the series  on 1/21/22
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Feet are swollen and she has some purple color marks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PERIPHERAL SWELLING (non-serious), outcome "unknown", described as "Feet are swollen and she has some purple color marks".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Illness, Stress
Clinical narrative: I had a very bad time, I am fatigue, tired and sick; it's very stressful, I felt worst and stayed in bed; I had a very bad time, I am fatigue, tired and sick; it's very stressful, I felt worst and stayed in bed; I had a very bad time, I am fatigue, tired and sick; it's very stressful, I felt worst and stayed in bed; I had a very bad time, I am fatigue, tired and sick; it's very stressful, I felt worst and stayed in bed; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 73 year-old female patient received bnt162b2 (BNT162B2), administration date 2021 (Lot number: ER8736) at the age of 73 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1ST DOSE, SINGLE), when the patient was 73 years old, for Covid-19 immunization, reaction(s): " first one was fine". The following information was reported: FATIGUE (non-serious), ILLNESS (non-serious), STRESS (non-serious), FEELING ABNORMAL (non-serious), outcome "unknown" and all described as "I had a very bad time, I am fatigue, tired and sick; it's very stressful, I felt worst and stayed in bed".  Additional information:Patient had his Pfizer second shot on Wednesday but the first one was fine, she didn't feel anything on the site (vaccination center) but after the second one had a very bad time, she was fatigue, tired and got up and feel the same way again. he just took an Aspirin (treatment) is this anything else he can do Patient added, patient 73 Years old but she never been sick, she take care of her husband and it's very stressful but she don't know what is wrong with her because the first one was fine." Patient said that she was fine till the first morning as woke up and after this second dose, felt this worst that she felt today and just stayed in bed and didn't "make dinner or nothing" (not clarified)."  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021532129 same reporter/drug/event different patient
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm/Ver, very little pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 (Lot number: ER8733, Expiration Date: 31Jul2021) at the age of 69 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gall bladder out" (unspecified if ongoing), notes: Had his gall bladder out 3 or 4 years ago; "Depression" (ongoing); "Cholesterol" (ongoing). Concomitant medication(s) included: BUPROPION taken for depression (ongoing); SERTRALINE taken for depression (ongoing); SIMVASTATIN taken for blood cholesterol (ongoing). Vaccination history included: Bnt162b2 (Drug(s) Information:, Characterization of drug role: Suspect, Proprietary medicinal product name: Pfizer Covid vaccine, Batch/lot number: EN6208  Expiry Date: 30Jun2021, Dosage text: First dose; upper left arm), administration date: 16Mar2021, when the patient was 69 years old, for COVID-19 Immunization, reaction(s): "Loose bowels/Diarrhea", "excess gas", "sore arm". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Apr2021, outcome "recovered" (Apr2021), described as "Sore arm/Ver, very little pain". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: The patient's sore arm did not last long lasted maybe 12 hours. Very little pain. It was the next day. The concomitant Products Bupropion XL, Simvastatin had been taken a couple of years, Sertraline Just started taking within the last year. No additional vaccines administered on same date of the Pfizer suspect.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Feeling abnormal, Hypoaesthesia, Paraesthesia, Paraesthesia oral
Clinical narrative: I have had like though out like my body; I am like tingling, prickliness with my leg was falling asleep; my foot is falling asleep; it comes and goes and it just kind of leave throughout; I have had like though out like my body; I am like tingling, prickliness with my leg was falling asleep; my foot is falling asleep; it comes and goes and it just kind of leave throughout; Feels like little pinching needles issue in my lips as well; I almost feel like you know like a body part is falling asleep and all of a sudden it starts to come back; Mild type numb feeling; Feels like little pinching needles issue in my lips as well; I almost feel like you know like a body part is falling asleep and all of a sudden it starts to come back; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization. The following information was reported: PARAESTHESIA (non-serious), FEELING ABNORMAL (non-serious) all with onset 2021, outcome "unknown" and all described as "I have had like though out like my body; I am like tingling, prickliness with my leg was falling asleep; my foot is falling asleep; it comes and goes and it just kind of leave throughout"; PARAESTHESIA ORAL (non-serious), DISCOMFORT (non-serious) all with onset 2021, outcome "unknown" and all described as "Feels like little pinching needles issue in my lips as well; I almost feel like you know like a body part is falling asleep and all of a sudden it starts to come back"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "unknown", described as "Mild type numb feeling".  Additional Information: Patient stated just received second dose of Pfizer an hour and about 20 minutes ago and since then patient have had like a though out like my body, patient like tingling, prickliness with leg was falling asleep and foot is falling asleep. But it comes and goes and it just kind of leave throughout. Kind of sometimes feels like little pinching needles issue in lips as well. Patient almost feel like a body part is falling asleep and then all of a sudden it starts to come back and kind of have like it. Mild type numb feeling but then it comes back after it, like coming and falling asleep. So feeling that all throughout but it just leaves the way out different parts of the body.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Noticed the swelling at the site, kind of warmth and redness; Noticed the swelling at the site, kind of warmth and redness; Noticed the swelling at the site, kind of warmth and redness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 05May2021 (Lot number: Unknown) as dose 2,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (1st dose), for Covid-19 immunization. The following information was reported: VACCINATION SITE SWELLING (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE WARMTH (non-serious), outcome "unknown" and all described as "Noticed the swelling at the site, kind of warmth and redness". Additional information:Reason for no lot number: of COVID-19 Vaccine: Complainant hung up abruptly/transfer incomplete. Consumer stated, I am sorry. I am having trouble understanding you. Lady on the recording and you also. What did you want, my phone number. Where are you located? Okay, just a simple question. I am looking at the paper, they gave us for me I got the vaccine. I got my second shot on Wednesday the 5th, okay? And I realized it takes 2-3 days for any side effects, mild side effects to go away. Okay, I noticed the swelling at the site, kind of warmth and redness. And is that a minor thing or should I be concerned about it?While requesting for permission to probe questions for a safety report, consumer abruptly hung up the call.Further probing could not be done as the consumer abruptly hung up the call. Hence, limited information was available over the call.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Headache
Clinical narrative: Headache; Diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 05May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious) with onset 07May2021, outcome "unknown", described as "Headache"; DIARRHOEA (non-serious) with onset 07May2021, outcome "unknown", described as "Diarrhea".  Additional information: It was reported that the reporter's husband (consumer) and her had Pfizer first shot on Wednesday but her (Husband) got headache yesterday and also diarrhea which he had all overnight, it seems. Now he is just wondering if that is possibly a side effect.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Dizziness, Headache, Lymphadenopathy, Nausea
Clinical narrative: sore throat; swollen glands; burning/aching lungs; burning/aching lungs; headache; nausea; dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01May2021 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: IRON; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Covid-19 (COVID vaccine details: (Product= COVID 19), brand=Pfizer, Lot number= EW0151, Lot unknown= False, Administration date= 10Apr2021,, administration time=10:30AM, dose number= 1), administration date: 10Apr2021, when the patient was 16 years old, for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "not recovered", described as "sore throat"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "swollen glands"; PULMONARY PAIN (non-serious), outcome "not recovered", BURNING SENSATION (non-serious), outcome "unknown" and all described as "burning/aching lungs"; FATIGUE (non-serious) with onset 11Apr2021, outcome "not recovered", described as "extreme fatigue"; HEADACHE (non-serious), outcome "not recovered", described as "headache"; NAUSEA (non-serious), outcome "not recovered", described as "nausea"; DIZZINESS (non-serious), outcome "not recovered", described as "dizziness". The events "sore throat", "swollen glands", "burning/aching lungs", "burning/aching lungs", "extreme fatigue", "headache", "nausea" and "dizziness" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of oropharyngeal pain, lymphadenopathy, pulmonary pain, fatigue, headache, nausea, dizziness.  Additional information: No other vaccine in four weeks. Other medications in two weeks was multi vitamin, iron, Zyrtec. Covid prior vaccination was yes. Covid tested post vaccination was no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Pulmonary pain
Clinical narrative: sore throat; swollen glands; burning/aching lungs; burning/aching lungs; headache; nausea; dizziness; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 16 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 01May2021 (Batch/Lot number: unknown) at the age of 16 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing). Concomitant medication(s) included: IRON; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Covid-19 (COVID vaccine details: (Product= COVID 19), brand=Pfizer, Lot number= EW0151, Lot unknown= False, Administration date= 10Apr2021,, administration time=10:30AM, dose number= 1), administration date: 10Apr2021, when the patient was 16 years old, for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "not recovered", described as "sore throat"; LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "swollen glands"; PULMONARY PAIN (non-serious), outcome "not recovered", BURNING SENSATION (non-serious), outcome "unknown" and all described as "burning/aching lungs"; FATIGUE (non-serious) with onset 11Apr2021, outcome "not recovered", described as "extreme fatigue"; HEADACHE (non-serious), outcome "not recovered", described as "headache"; NAUSEA (non-serious), outcome "not recovered", described as "nausea"; DIZZINESS (non-serious), outcome "not recovered", described as "dizziness". The events "sore throat", "swollen glands", "burning/aching lungs", "burning/aching lungs", "extreme fatigue", "headache", "nausea" and "dizziness" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of oropharyngeal pain, lymphadenopathy, pulmonary pain, fatigue, headache, nausea, dizziness.  Additional information: No other vaccine in four weeks. Other medications in two weeks was multi vitamin, iron, Zyrtec. Covid prior vaccination was yes. Covid tested post vaccination was no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Mobility decreased, Pain, Vaccination site pain
Clinical narrative: Arm soreness at injections site, 2nd dose; Fatigue/very tired; achy all over the body; hard to raise her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 27Apr2021 09:30 (Lot number: EW0171) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Arthritis in her knees" (unspecified if ongoing), notes: Diagnosed about 5 years ago.; "migraines" (unspecified if ongoing). Concomitant medication(s) included: ALEVE taken for headache. Vaccination history included: Bnt162b2 (LOT: EW0150, Dose: 1, Anatomical location: left arm), administration date: 06Apr2021, when the patient was 55 years old, for COVID-19 immunization, reaction(s): "Arm soreness at injections site, 1st dose". The following information was reported: VACCINATION SITE PAIN (non-serious) with onset Apr2021, outcome "recovered" (29Apr2021), described as "Arm soreness at injections site, 2nd dose"; FATIGUE (non-serious) with onset Apr2021, outcome "recovered" (29Apr2021), described as "Fatigue/very tired"; PAIN (non-serious) with onset Apr2021, outcome "recovered" (29Apr2021), described as "achy all over the body"; MOBILITY DECREASED (non-serious) with onset Apr2021, outcome "recovered" (29Apr2021), described as "hard to raise her arm". Therapeutic measures were taken as a result of vaccination site pain, fatigue, pain, mobility decreased.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not had vaccines before but, she was not sure if they were Pfizer. Mild side effects right after the vaccine: The patient experienced fatigue, all over body aches, very tired and was hard to raise her arm but, it did not last but, 24 hours maybe. It started in the evening of day of the vaccine and she felt achy the next day after. It was gone on 29Apr2021. She reports she was able to work through it, she works from home. Caller reports the arm soreness was to be expected and went away a few days after getting the shot. The soreness was in the arm is to be expected, she was assuming, right.   No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Insomnia, Pain in extremity
Clinical narrative: sore arm; unable to sleep well; tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 16Apr2021 (Lot number: EWO153) at the age of 58 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "enlarged thyroid" (unspecified if ongoing), notes: enlarged thyroid. The patient took concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 07May2021 11:00, outcome "not recovered", described as "sore arm"; INSOMNIA (non-serious) with onset 07May2021 11:00, outcome "not recovered", described as "unable to sleep well"; FATIGUE (non-serious) with onset 07May2021 11:00, outcome "not recovered", described as "tired". Therapeutic measures were not taken as a result of pain in extremity, insomnia, fatigue.  Additional information: Other medications in two weeks included dietary supplements and herbal remedies. No other vaccine in four weeks. Adverse event: 1st dose: major sore arm resulting in unable to sleep well, tired. No covid prior vaccination and no covid tested post vaccination. No known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu-like symptoms; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Flu-like symptoms".   Additional information: Reported she had 4 more friends with flu like symptoms. She clarified every women she talked to about the COVID-19 Vaccine, all had the same type of symptoms after the first COVID-19 Vaccine dose. She said she didn't remember the rest of the women, or have any information on what COVID-19 Vaccine they had.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021522956 same reporter/SD/AE, different patient.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: My reaction to the first needle it was terrible; I never felt so bad in all my life like I did last Friday; that's why I am refusing the second shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2 (BNT162B2), administration date 04May2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FEELING ABNORMAL (non-serious) with onset 07May2021, outcome "unknown", described as "My reaction to the first needle it was terrible; I never felt so bad in all my life like I did last Friday; that's why I am refusing the second shot".  Additional information: The patient had an appointment on 25May2021 for second shot and she had the severe effect/ bad reaction from the first shot last Friday so she was not taking the second shot. She just want to tell them that they can give her space to somebody else on 25May2021. Her reaction to the first needle was terrible and she will not, she was an older lady, she will be 95 in June She never felt so bad in all her life. She was informed about the Pfizer Medical Information and provided with the number as # requested to dial the option 3 and informed about timings as 8 AM to 8 PM from Monday to Friday and for Saturday and Sunday timings are 9 AM to 3 PM as per EST.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Vaccination site pain
Clinical narrative: First dose: a little tired; First dose: left arm was sore; First dose: felt the pinch when she received the vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 16Apr2021 14:00 (Lot number: EP7534) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Migraine" (ongoing), notes: Verbatim: Migraine; "She ate a piece of the candy." (unspecified if ongoing), notes: Verbatim: Her friend had traveled overseas and brought back foreign candy and she ate a piece of the candy. Within 20 minutes of eating the candy her eyes started to get itchy and the hives started. The patient's concomitant medications were not reported. Past drug history included: Keflex for Drug allergy, reaction(s): "diarrhoea", notes: Verbatim: She reports she's allergic to Keflex. She got really bad diarrhea when she took Keflex. This happened about 3 or 4 years ago. NDC/Lot/Expiry not known for Keflex. The following information was reported: FATIGUE (non-serious) with onset 17Apr2021, outcome "recovered" (Apr2021), described as "First dose: a little tired"; PAIN IN EXTREMITY (non-serious) with onset 17Apr2021, outcome "recovered" (Apr2021), described as "First dose: left arm was sore"; VACCINATION SITE PAIN (non-serious) with onset 16Apr2021, outcome "recovered" (Apr2021), described as "First dose: felt the pinch when she received the vaccine".  Additional Information: When probing for information regarding her side effects with the Covid 19 vaccines she reports Patient received the first Covid 19 vaccine on 16Apr2021 and with the first dose patient was a little tired and her left arm was sore. Patient felt the pinch when she received the vaccine. It was the next day she noticed, on 17Apr2021, her tiredness and her arm soreness. The arm soreness only lasted about 2 days. The tiredness only lasted for a day. When probing medical history and concomitant medications, Patient reports she takes migraine medicine when patient needs to but she did not get a migraine with the Covid 19 vaccines. Patient declines to provide the name of the medication. No, prior vaccinations within 4 weeks and No, AE following prior vaccination. No AE require a visit to emergency room and physician office. No prior vaccinations (within 4 weeks).  No follow-up attempts are possible. No further information is expected.