chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chest discomfort, Limb discomfort, Lymphadenopathy
Clinical narrative: Swollen lymph nodes under her arm pit; Discomfort under her arm; Discomfort under her arm pit; Chest discomfort; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received bnt162b2 ( (PFIZER BIONTECH COVID19 VACCINE), via an unspecified route of administration in arm left on 29Mar2021 at age of 73-year-old as dose 2, single for COVID-19 immunization.  The patient's medical history was not reported. The patient's concomitant medication included antibiotics, sulfamethoxazole, trmethoprim (reported as SULFA TMP or BACTRIM) for antibiotic therapy. On an unspecified date, the patient previously received bnt162b2 as dose 1, single for COVID-19 immunization.  After her first shot, the patient had nothing. On 30Mar2021, the patient experienced swollen lymph nodes under her armpit, discomfort under her arm, discomfort under her arm pit and chest discomfort. Around 3:00 or 4:00 pm on 30Mar2021, the patient had discomfort under her arm and arm pit. The patient suspected lymph nodes under her armpit that were bothering on 30Mar2021. It was not very comfortable. The patient didn't feel it on 29Mar2021.That was the reaction that the patient had swollen lymph nodes. Her shot was in a straight line to her arm pit. The patient had an appointment with her primary on Monday. The patient wanted to know how long this would last and whether had any information. Swollen lymph nodes which generally resolved within 10 days was likely to have resulted from a robust vaccine-elicited immune response. The patient stated that this arm pit thing bothered her, and she did not recall what they said at the site where she got the shot and she did not know if she should keep a watch on it and then if it lasted a few days whether call her doctor or not. The patient stated it started under her arm and it was spreading towards her chest, it was not comfortable at all and she did not know how long this might last. The patient stated that she had done none, it just started happening an hour ago, and she didn't know if she should do anything. She stated whether she were to apply cold to armpit area since it was in direct line with vaccine site so cold could make the vaccine congeal, and she used heat it could make vaccine dissipate, so she was not sure about doing this. She stated it was on the same side where she got the vaccine, and if she presses where she got the vaccine it was a direct line to under her armpit. The outcome of these events was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vaccination site bruising
Clinical narrative: headache; ran down and tired; left arm on her injection site felt like it was bruised; nauseated; This is a spontaneous report from a contactable consumer (patient) received via medical information team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Lot number was not reported), via an unspecified route of administration, administered in left arm, on 26Mar2021 as dose 1, single for COVID-19 immunization. The patient's medical history included being immunocompromised, neck surgery (pretty intensive and took a long time to heal) on May2020, stage 1 melanoma cancer and was removed on 03Dec2020, chronic pains and arthritis. The patient's concomitant medications were not reported. The patient's historical vaccine included flu shot. On Mar2021, the patient experienced headache; ran down and tired, left arm on her injection site felt like it was bruised (like somebody punched it) and nauseated. It was reported that the patient mentioned that this felt like the flu shot but worse. The patient was very wary of getting the 2nd dose because she might experience these side effects again. The patient heard that the 2nd dose might give worse side effects and would like to clarify that. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021362558 same reporter and drug, different patient and event
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After receiving 2nd dose of Pfizer's vaccine, had pain relief as well, short term.; This is a spontaneous report from a contactable healthcare professional, the patient. A 38-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL3302) via an unspecified route of administration in the left arm on 26Jan2021 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. Medical history included GERD, allergies, bee sting hypersensitivity (bees), contrast media allergy (contrast dye), chronic pain, injury at the age of 16 and COVID-19 in Oct2020. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included ibuprofen (MANUFACTURER UNKNOWN), cetirizine hydrochloride (ZYRTEC) and omeprazole (MANUFACTURER UNKNOWN); all taken for unknown indications from unknown dates and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL0140) via intramuscular route of administration in the left arm on an unknown date in Jan2021 at 14:00 (at the age of 38-years-old) as a single dose for COVID-19 immunisation. On 26Jan2021 at 14:00, the patient had short term pain relief. The patient had lived with chronic pain for 22 plus years of life due to an injury at age 16. She actually had COVID-19 in October 2020 and about 6-7 days into it, had chronic pain relief for about 1 week. She felt no every day pain. After receiving the second dose of Pfizer's vaccine, she had pain relief as well, short term. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the reported event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event lived with chronic pain for 22 plus years of life due to an injury at age 16 and after receiving 2nd dose of Pfizer's vaccine, pain relief as well, short term was recovered on an unknown date in 2021.   No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction; This is a spontaneous report from a contactable nurse (patient). A patient of an unspecified age and gender received bnt162b2 (COMIRNATY; formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 28Mar2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced allergic reaction to COVID-19 vaccine on an unspecified date in 2021. The event took place after the use of product. The clinical outcome for the event was unknown.  Information on the lot/batch number has been requested.  One follow-up attempt was completed; information about batch/lot cannot be obtained.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Feeling abnormal, Headache
Clinical narrative: chills so bad; Muscle pain; felt so bad; headaches really bad; fatigued; Dry cough; This is a spontaneous report from a contactable consumer (patient) (phlebotomist). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6202 and expiration date not reported), via an unspecified route of administration, administered in Arm Left on 13Mar2021 09:30 (at the age of 51-year-old), as dose 1, single, for COVID-19 immunisation in hospital. Medical history included one kidney and high blood pressure. Concomitant medications included losartan (50mg once a day) taken for one kidney and high blood pressure; clobetasol (0.6mg tablet by mouth daily) taken for high blood pressure; furosemide (LASIX [FUROSEMIDE] (40 mg once a day) taken for high blood pressure all from an unspecified start date from last 4 to 5 years or maybe longer and was ongoing. No prior vaccinations within 4 weeks of COVID vaccine. No additional vaccines were administered on same date of the Pfizer suspect. On the 22Mar2021, the patient started getting sick. The patient had so bad chills and muscle pain, felt so bad, had really bad headaches, fatigued and dry cough. On 26Mar2021, the muscle pain, headache and chills were better. She was still having the fatigue and cough. It was reported that 26Mar2021 was the first day out of bed since 22Mar2021. The patient called her physician because she was really concerned. Her physician said that it was from the vaccine and to take Tylenol and rest. The outcome of chills, muscle pain, headaches and fatigued was recovering; the outcome of felt so bad was unknown while the outcome of dry cough was not recovered.   No follow up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: chills so bad; Muscle pain; felt so bad; headaches really bad; fatigued; Dry cough; This is a spontaneous report from a contactable consumer (patient) (phlebotomist). A 51-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; lot number: EN6202 and expiration date not reported), via an unspecified route of administration, administered in Arm Left on 13Mar2021 09:30 (at the age of 51-year-old), as dose 1, single, for COVID-19 immunisation in hospital. Medical history included one kidney and high blood pressure. Concomitant medications included losartan (50mg once a day) taken for one kidney and high blood pressure; clobetasol (0.6mg tablet by mouth daily) taken for high blood pressure; furosemide (LASIX [FUROSEMIDE] (40 mg once a day) taken for high blood pressure all from an unspecified start date from last 4 to 5 years or maybe longer and was ongoing. No prior vaccinations within 4 weeks of COVID vaccine. No additional vaccines were administered on same date of the Pfizer suspect. On the 22Mar2021, the patient started getting sick. The patient had so bad chills and muscle pain, felt so bad, had really bad headaches, fatigued and dry cough. On 26Mar2021, the muscle pain, headache and chills were better. She was still having the fatigue and cough. It was reported that 26Mar2021 was the first day out of bed since 22Mar2021. The patient called her physician because she was really concerned. Her physician said that it was from the vaccine and to take Tylenol and rest. The outcome of chills, muscle pain, headaches and fatigued was recovering; the outcome of felt so bad was unknown while the outcome of dry cough was not recovered.   No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Pyrexia
Clinical narrative: exhaustion; joint pain; fever; This is a spontaneous report from a contactable consumer reported for a patient (Cousin's wife). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced exhaustion, joint pain and fever. Reported need to report two instances of adverse side effects that was told by a family member that received the 2nd dose of the Covid-19 vaccination. Reporter cousin's wife received the 2nd dose in (State name). Reporter cousin let reporter know that his wife, who had MS, experienced: exhaustion, joint pain and fever. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Balance disorder, Blepharospasm, Bronchitis, Decreased appetite, Depression
Clinical narrative: Lump in throat; Pressure in sinuses and head; Pressure in sinuses and head; clogged ears; pain under left rib cage; off balance; tinnitus; brain fog; severe depression; anorexia; hot flashes; left eye twitch on and off; sore arm; bad cold symptoms; a low grade fever; bronchitis symptoms; Phelgm; post nasal drip; indigestion; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6208, Expiration date was not reported), via an unspecified route of administration in arm left on 10Mar2021 at 11:30 AM (at the age of 56-year-old) as a dose number unknown, single for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease and known allergies: penicillin. The patient's concomitant medications received within 2 weeks of vaccination was reported as yes. It was reported that, the patient was not pregnant at the time of vaccination. 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, has the patient been tested for COVID-19 was reported as yes. On 10Mar2021 at 11:30 AM, the patient experienced lump in throat, pressure in sinuses and head, clogged ears, pain under left rib cage, off balance, tinnitus, brain fog, severe depression, anorexia, hot flashes, left eye twitch on and off, sore arm. Then, she had bad cold symptoms for 4 days and then a low-grade fever with bronchitis symptoms for going on 12 days and not cleared up yet. Stated that, phelgm has been clear though so she thinks that was a reaction to the vaccine. Stated that, four days after vaccine, the patient used a saline nasal spray and it caused postnasal drip and indigestion on an unspecified date in 2021 and she was on for over 24 hours because of having to clear her throat. The reporter considered the seriousness of the events as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events postnasal drip and indigestion while for the other events was unknown. On 17Mar2021, the patient underwent lab tests and procedures which included Nasal Swab/PCR (SARS-CoV-2 test), resulted as negative on 23Mar2021, Nasal Swab/PCR (SARS-CoV-2 test), resulted as negative, covid test name post vaccination was PCR. The outcome of the events was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Ear discomfort, Feeling abnormal, Head discomfort, Hot flush
Clinical narrative: Lump in throat; Pressure in sinuses and head; Pressure in sinuses and head; clogged ears; pain under left rib cage; off balance; tinnitus; brain fog; severe depression; anorexia; hot flashes; left eye twitch on and off; sore arm; bad cold symptoms; a low grade fever; bronchitis symptoms; Phelgm; post nasal drip; indigestion; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6208, Expiration date was not reported), via an unspecified route of administration in arm left on 10Mar2021 at 11:30 AM (at the age of 56-year-old) as a dose number unknown, single for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease and known allergies: penicillin. The patient's concomitant medications received within 2 weeks of vaccination was reported as yes. It was reported that, the patient was not pregnant at the time of vaccination. 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, has the patient been tested for COVID-19 was reported as yes. On 10Mar2021 at 11:30 AM, the patient experienced lump in throat, pressure in sinuses and head, clogged ears, pain under left rib cage, off balance, tinnitus, brain fog, severe depression, anorexia, hot flashes, left eye twitch on and off, sore arm. Then, she had bad cold symptoms for 4 days and then a low-grade fever with bronchitis symptoms for going on 12 days and not cleared up yet. Stated that, phelgm has been clear though so she thinks that was a reaction to the vaccine. Stated that, four days after vaccine, the patient used a saline nasal spray and it caused postnasal drip and indigestion on an unspecified date in 2021 and she was on for over 24 hours because of having to clear her throat. The reporter considered the seriousness of the events as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events postnasal drip and indigestion while for the other events was unknown. On 17Mar2021, the patient underwent lab tests and procedures which included Nasal Swab/PCR (SARS-CoV-2 test), resulted as negative on 23Mar2021, Nasal Swab/PCR (SARS-CoV-2 test), resulted as negative, covid test name post vaccination was PCR. The outcome of the events was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal chest pain, Nasopharyngitis, Pain in extremity, Paranasal sinus discomfort, Productive cough
Clinical narrative: Lump in throat; Pressure in sinuses and head; Pressure in sinuses and head; clogged ears; pain under left rib cage; off balance; tinnitus; brain fog; severe depression; anorexia; hot flashes; left eye twitch on and off; sore arm; bad cold symptoms; a low grade fever; bronchitis symptoms; Phelgm; post nasal drip; indigestion; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6208, Expiration date was not reported), via an unspecified route of administration in arm left on 10Mar2021 at 11:30 AM (at the age of 56-year-old) as a dose number unknown, single for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease and known allergies: penicillin. The patient's concomitant medications received within 2 weeks of vaccination was reported as yes. It was reported that, the patient was not pregnant at the time of vaccination. 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, has the patient been tested for COVID-19 was reported as yes. On 10Mar2021 at 11:30 AM, the patient experienced lump in throat, pressure in sinuses and head, clogged ears, pain under left rib cage, off balance, tinnitus, brain fog, severe depression, anorexia, hot flashes, left eye twitch on and off, sore arm. Then, she had bad cold symptoms for 4 days and then a low-grade fever with bronchitis symptoms for going on 12 days and not cleared up yet. Stated that, phelgm has been clear though so she thinks that was a reaction to the vaccine. Stated that, four days after vaccine, the patient used a saline nasal spray and it caused postnasal drip and indigestion on an unspecified date in 2021 and she was on for over 24 hours because of having to clear her throat. The reporter considered the seriousness of the events as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events postnasal drip and indigestion while for the other events was unknown. On 17Mar2021, the patient underwent lab tests and procedures which included Nasal Swab/PCR (SARS-CoV-2 test), resulted as negative on 23Mar2021, Nasal Swab/PCR (SARS-CoV-2 test), resulted as negative, covid test name post vaccination was PCR. The outcome of the events was not recovered.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, SARS-CoV-2 test, Sensation of foreign body, Tinnitus, Upper-airway cough syndrome
Clinical narrative: Lump in throat; Pressure in sinuses and head; Pressure in sinuses and head; clogged ears; pain under left rib cage; off balance; tinnitus; brain fog; severe depression; anorexia; hot flashes; left eye twitch on and off; sore arm; bad cold symptoms; a low grade fever; bronchitis symptoms; Phelgm; post nasal drip; indigestion; This is a spontaneous report received from a contactable consumer (patient). A 56-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EN6208, Expiration date was not reported), via an unspecified route of administration in arm left on 10Mar2021 at 11:30 AM (at the age of 56-year-old) as a dose number unknown, single for COVID-19 immunization. The patient's medical history included chronic obstructive pulmonary disease and known allergies: penicillin. The patient's concomitant medications received within 2 weeks of vaccination was reported as yes. It was reported that, the patient was not pregnant at the time of vaccination. 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, has the patient been tested for COVID-19 was reported as yes. On 10Mar2021 at 11:30 AM, the patient experienced lump in throat, pressure in sinuses and head, clogged ears, pain under left rib cage, off balance, tinnitus, brain fog, severe depression, anorexia, hot flashes, left eye twitch on and off, sore arm. Then, she had bad cold symptoms for 4 days and then a low-grade fever with bronchitis symptoms for going on 12 days and not cleared up yet. Stated that, phelgm has been clear though so she thinks that was a reaction to the vaccine. Stated that, four days after vaccine, the patient used a saline nasal spray and it caused postnasal drip and indigestion on an unspecified date in 2021 and she was on for over 24 hours because of having to clear her throat. The reporter considered the seriousness of the events as non-serious. The adverse events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of the events postnasal drip and indigestion while for the other events was unknown. On 17Mar2021, the patient underwent lab tests and procedures which included Nasal Swab/PCR (SARS-CoV-2 test), resulted as negative on 23Mar2021, Nasal Swab/PCR (SARS-CoV-2 test), resulted as negative, covid test name post vaccination was PCR. The outcome of the events was not recovered.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: moderate soreness at injection site 12 hours after; mild achy joints (knees, hips) 24 hours after; redness/tenderness/heat at injection site 48 hours after; redness/tenderness/heat at injection site 48 hours after; redness/tenderness/heat at injection site 48 hours after; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 30-years-old non-pregnant female patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Lot number: ER8732), via an unknown route of administration in left arm on 26Mar2021 at 11:00 (at the age of 30-years-old) as dose 2, single for COVID-19 immunization. The patient's medical history was not reported. She had no known allergies. Concomitant medication included escitalopram (ESCITALOPRAM) for an unknown indication from an unknown date. No other vaccine in four weeks. Other medications in two weeks were birth control, escitalopram and multivitamin. The patient received BNT162B2 (Pfizer-Biontech COVID-19 Vaccine, solution for injection, Lot number: EN6199), via an unknown route of administration in left arm on 05Mar2021 at 13:00 as historical vaccine (at the age of 30-years-old) as dose 1, single for COVID-19 immunization and experienced very mild soreness at injection site. On 27Mar2021 at 04:00, the patient experienced moderate soreness at injection site 12 hours after, mild achy joints (knees, hips) 24 hours after and redness/tenderness/heat at injection site 48 hours after. No COVID prior vaccination. No COVID tested post vaccination. No treatment for events. The outcome of the events was not recovered.  No follow up attempts are possible. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Eye disorder, Headache, Mydriasis
Clinical narrative: Severe headache, within a couple of minute of vaccine. It turned to a dull headache in about 5 min; Eye sensitivity; "My" eyes feel as if I had them dilated at the dr's; This is a spontaneous report from a contactable consumer, the patient. A 49-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8732) via an unspecified route of administration in the left arm on 30Mar2021 at 11:00 (at the age of 49-year-old), as a single dose for COVID-19 immunisation. Medical history included chronic migraine, allergy to sulfa and wheat. 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 COVID vaccine. Concomitant medications included levothyroxine (MANUFACTURER UNKNOWN), lamotrigine (MANUFACTURER UNKNOWN), estradiol (MANUFACTURER UNKNOWN), clonidine (MANUFACTURER UNKNOWN), erenumab (AIMOVIG), botulinum toxin type a (BOTOX), rizatriptan (MANUFACTURER UNKNOWN), ibuprofen (MANUFACTURER UNKNOWN) and unspecified epidural; all taken for unknown indication from unknown dates and unknown if ongoing. On 30Mar2021 at 12:00, the patient experienced severe headache, within a couple of minutes of vaccine. It turned to a dull headache in about 5 minutes and had continued for all day. The patient also experienced eye sensitivity and felt as if had eyes dilated at the doctors. This started about an hour after the vaccine and continued to feel that way about 9 hours later. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events severe headache, dull headache, eye sensitivity and eyes felt as if dilated was not recovered at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Pyrexia, Urticaria, Vaccination site pain
Clinical narrative: itching from her waist down to knees and on her elbows, and it almost looks like welts or hives; itching from her waist down to knees and on her elbows, and it almost looks like welts or hives; Injection site ache on left arm/injection site pain; Low grade fever; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6203), via an unspecified route of administration in the left arm on 22Mar2021 at 13:00 (at the age of 68-year-old), dose 2, single for COVID-19 immunisation. Medical history included ongoing high blood pressure and ongoing high cholesterol (started 15 years ago maybe). The patient had no family history. The patient did not receive any concomitant medications. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EN6201) administered via an unspecified route of administration on 01Mar2021 (at the age of 68-year-old), dose 1, single for COVID-19 immunisation. The patient did not administer any additional vaccine on the same day of COVID-19 vaccine and did not experience any adverse events. On 22Mar2021 afternoon the patient had the usual injection site pain. The patient stated the left arm was more of an ache than a pain and she still have it but it was getting better.  On the same day in the evening, the patient had a low-grade fever that only lasted for twenty-four hours and then it was gone. The patient stated that she started itching on 25Mar2021 at 11:00 from her waist down to knees and on her elbows, and it almost looks like welts or hives. The patient stated that she put some Eucerin cream on it and it has subsided a bit with the cream. The patient stated that the paper said she may get a rash, but this was not all over her body. The patient was asking if this could be from the vaccine. The patient stated that she was wondering if she could take some Benadryl to help.  The events did not result in emergency room visit or physician office visit. The outcome of the event low grade fever was recovered on 23Mar2021 and outcome of other events was recovering.  No follow-up attempts are possible; No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis, Pain, Pyrexia
Clinical narrative: Headaches; Fever; Intermittent sweating; Chills; Body aches; This is a spontaneous report from a non-contactable consumer (patient). This report was received via a sales representative. A male patient of an unspecified age (Age: 53; Unit: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 2 via an unspecified route of administration on 17Mar2021 10:00 as DOSE 2, SINGLE for covid-19 immunization. Patient medical history included high blood pressure and type 2 diabetes from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Historical vaccine included received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, SINGLE for covid-19 immunization. On 18Mar2021 02:00, the patient experienced headaches, fever, intermittent sweating, chills and body aches. It was reported that the events took place after use of the product. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Nausea, Pain
Clinical narrative: Nausea; body ache; fatigue; joint pain; This is a spontaneous report from a contactable consumer (patient) via a Sales Representative. A 50-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiration date were not reported), via an unspecified route of administration on an unspecified date, dose 2, single for COVID-19 immunisation. Medical history included controlled multiple sclerosis. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced nausea, body ache, joint pain and fatigue. The outcome of the events was unknown.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Blood pressure measurement, Fatigue, Feeling abnormal
Clinical narrative: Very Noticeable Decline in Blood Pressure; Tiredness; felt funky; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on 26Mar2021 at 10:10 (Batch/Lot number was not reported) (at the age of 69 years old) as dose 2, single for COVID-19 immunisation in a hospital. Medical history included systolic hypertension from 2008 and ongoing (high blood pressure/ systolic hypertension); ongoing arrhythmia; ongoing blood thinner use. Concomitant medications included metoprolol taken for high blood pressure on 2015 and ongoing (for 5-6 years); amlodipine taken for high blood pressure and arrhythmia on 2019 and ongoing (for 2 years); apixaban (ELIQUIS) taken as blood thinner on 2019 and ongoing (for 2 years); flecainide taken for arrhythmia on 2019 and ongoing (for 2 years). The patient was previously administered the first dose of BNT162B2, via an unspecified route of administration, administered in right arm, on 05Mar2021 (Batch/Lot number was EN6206, however also reported as EL9265) (at the age of 69 years old) as dose 1, single for COVID-19 immunisation. The patient experienced very noticeable decline in blood pressure, tiredness and felt funky on 26Mar2021. Clinical course of events was as follow: On an early evening of 26Mar2021, the patient experienced a very noticeable decline in her blood pressure. It was 99/39 while on medications for high blood pressure which was an abnormally low reading. The patient waited for 15 minutes and felt fine but felt funky on her drive home but not terrible. The patient was tired after the second shot but didn't think anything of that and stated that it was spotty now, she was back to her normal cleaning and yard work, it has improved. Treatment included adjusted dose of blood pressure medications, reduced by half, then fourth and then none today; cetirizine for a couple of days and sipped electrolyte water. The patient spoke to an urgent care on a call last night (29Mar2021) because her blood pressure was 99/41 to ask if she should make a trip to emergency room due to low blood pressure. They told her to drink electrolyte water and if it further decrease, to go to general practitioner, but if it was staying stable, she was okay. The events did not lead to emergency room or physician office visit. The patient underwent lab tests and procedures which included very noticeable decline in blood pressure: 99/39 on 26Mar2021; 104/46 on 29Mar2021; 99/41 on 29Mar2021. The outcome of events very noticeable decline in blood pressure and tiredness was recovering; the event felt funky was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Joint range of motion decreased, Vaccination site movement impairment, Vaccination site pain
Clinical narrative: Excruciating pain in R arm; Shoulder was immobile; Shooting pain bone deep radiating down R arm; R arm still has limited mobility; This is a spontaneous report from a contactable consumer (patient). A 50-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number:  EN6202, Expiration Date: not reported) via an unspecified route of administration, administered in right arm on 27Mar2021 at 08:30 (at the age of 50 years old) as dose 1, single for COVID-19 immunisation. Medical history included mitral valve stenosis and GERD (gastrooesophageal reflux disease), both from an unknown date. The patient has no known allergies and prior to vaccination the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC) and esomeprazole sodium (NEXIUM), both taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 27Mar2021 at 08:30, the patient experienced excruciating pain in right arm and patient's shoulder was immobile. Furthermore, the patient also experienced shooting pain bone deep radiating down right arm on the same day. The pain was so extreme the patient had to go to the emergency room. The pain increased throughout the day despite ibuprofen and naproxen sodium. The pain started on 27Mar2021 at 08:30 with the injection and the immobilization of the patient's right arm remained for 2 days after ER visit. The patient's right arm still has limited mobility. Treatment was given in response to the events which included ibuprofen, naproxen sodium, lidocaine patch, paracetamol (TYLENOL), hydrocodone bitartrate;paracetamol (NORCO) and diazepam (VALIUM). Since vaccination, the patient has not been tested for COVID-19. Events resulted to doctor or other healthcare professional office/clinic visit and Emergency room/department or urgent care. Outcome of all events was recovering.  No follow up attempts are possible. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: had pain in her knees while sitting, walking/the pain is consistent and has not left; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 63-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EL9269, expiration date: 31May2021), via an unspecified route of administration, administered in arm right on 11Feb2021 as dose 1, single (at the age of 63-year-old) and second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, lot number: EN6203, expiration date: Jun2021), via an unspecified route of administration, administered in arm right on 04Mar2021 as dose 2, single for covid-19 immunization. Medical history included ongoing hypertension from 2006 (diagnosed about 15 years ago), knee replacement surgery from 2015 (surgery was 6 years ago) and ongoing blood cholesterol increased from 2006 (diagnosed about 15 years ago). Concomitant medications included meloxicam and tramadol both taken for knee pain from an unspecified start date and ongoing. On 12Feb2021, the patient experienced pain in her knees while sitting, walking. The pain was consistent and had not left. The patient had both Pfizer Covid vaccines, first dose was 11Feb2021, second dose was 04Mar2021, caller states she has experienced knee pain after the first dose, states she has had knee replacement surgery but had no issues until that first vaccine, states the pain is in both knees, the replaced knee, and the other knee, states it has been persistent since the first dose through the second dose. States it does not matter what she is doing, walking, standing, climbing moving, it is always there, nothing makes it worse.  Patient wanted to know if this could be a side effect of the vaccine. The outcome of the event was not recovered.  No follow-up attempts were needed. No further information was expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Hypersensitivity, Nervousness
Clinical narrative: Difficulty in swallowing; Nervous; allergies are kind of heightened right now; This is a spontaneous report from a contactable consumer (Patient).A 59-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Lot Number: EN6207; Expiration Date: 31Jul2021), via intramuscular route of administration, administered in Arm Left on 13Mar2021 as dose 1, 30ug single (at the age of 59-years) for COVID-19 immunization. Medical history included Allergy, breast cancer, allergy to pollens, allergy to grass, allergy to dogs, cats, weeds and trees. Patient took allergy shot once a month and Zyrtec as needed. Concomitant medications included tamoxifen (TAMOXIFEN) taken for breast cancer (It's for the follow up therapeutic type of drug probably) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) taken for an unspecified indication, 10 mg as needed. On an unspecified date in 2021, the patient experienced allergy and on 13Mar2021, 20 minutes after she had the shot, she had the difficulty in swallowing. So, did take an allergy pill immediately and symptoms start to subsided but she was getting nervous. The patient stated it's just she do have regular allergies. She got allergy shots as well. So, her allergies are kind of heightened right now. The patient stated she already reported her side effects. She was scheduled for another dose on Saturday 03Apr2021. So, she wanted to see, also she doesn't know if can say, can she take a allergy pill before she get it, should she take the 2nd dose or do check with someone else. She was scheduled to have her second dose 03Apr2021 and was wondering if she should continue with the second dose if she had side effects after the first dose. Therapeutic measures were taken as a result of event allergy and Swallowing difficult. The outcome of allergy was unknown and patient was recovering from difficulty in swallowing and nervousness.  Follow-up attempts completed. No further information expected.
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: His right eye looks very red; This is a spontaneous report from a contactable consumer or other non-HCP (patient himself). A 44-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6207, Expiry Date-UNKNOWN) via an unspecified route of administration in right arm on 28Mar2021 10:00 as dose 1, single (at the age of 44 years-old) for COVID-19 immunization (patient taking Pfizer COVID-19 vaccine (Verbatim) due to possible overweight). Patient Medical History (including any illness at time of vaccination) was none. There were no concomitant medications (other Products). Family medical history relevant to ae was none. Vaccination facility type was other (pop up clinic) and vaccine administered at military facility. the facility name address was unknown. Additional vaccines administered on same date of the pfizer suspect additional administered vaccines if applicable, list all vaccines administered on same date with the pfizer vaccine considered as suspect reported as none. History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was none. Prior Vaccinations (within 4 weeks), list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine was none. The patient recently experienced that his right eye looks very red on 31Mar2021. It was reported that action taken with drug was unknown. The report is not related to a study or programme. Patient questions about if this could have been caused by the COIVD-19 vaccine. Investigation Assessment reported as none. It was reported that patient doesn't have a doctor, didn't go see a doctor. Patient was not visited to emergency room and physician office. No therapeutic measures were taken for event. The clinical outcome of event was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Exposure to SARS-CoV-2, Fatigue, Feeling cold, Headache
Clinical narrative: Feeling of coldness; Nausea; Severe headache; Tiredness/fatigue/super tired; Felt like she had the flu; chills; Muscle pain; The caller was exposed to covid last Saturday; Body ache; Didn't feel well at all; This is a spontaneous report received from a contactable consumer. A 60-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: not reported) via an unspecified route of administration on 15Mar2021 as Dose 1,Single for COVID-19 immunization. The patient's medical history included Blood pressure high diagnosed about 5 years ago. The patient reported that a day after the 2nd dose of vaccine on 16Mar2021 at 1:00am she had very bad side effects like feeling of coldness, nausea, severe headache tiredness felt like she had the flu,chills and fatigue. The patient experienced body ache, muscle pain and didn't feel well at all on an unspecified date. All of this lasted for 36 hours. She took extra strength Tylenol after 24 hours and it helped. She asked if she is going to get the same or more severe symptoms because I heard that it is worse with the second dose and if she is not able to take her second dose in 21 days, because they are having an outbreak there, how long should it be before she should get the second dose. The patient was exposed to covid last Saturday and she was only exposed for about 7 hours. The patient's friend tested positive 2 weeks after the vaccine. And received the vaccine on the same day as the patient. The reporter also wants to know how long to wait to get the second dose if you test positive for covid after the first dose. The outcome of the events were recovered on 17Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza, Malaise, Myalgia, Nausea, Pain
Clinical narrative: Feeling of coldness; Nausea; Severe headache; Tiredness/fatigue/super tired; Felt like she had the flu; chills; Muscle pain; The caller was exposed to covid last Saturday; Body ache; Didn't feel well at all; This is a spontaneous report received from a contactable consumer. A 60-year-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Lot number: not reported) via an unspecified route of administration on 15Mar2021 as Dose 1,Single for COVID-19 immunization. The patient's medical history included Blood pressure high diagnosed about 5 years ago. The patient reported that a day after the 2nd dose of vaccine on 16Mar2021 at 1:00am she had very bad side effects like feeling of coldness, nausea, severe headache tiredness felt like she had the flu,chills and fatigue. The patient experienced body ache, muscle pain and didn't feel well at all on an unspecified date. All of this lasted for 36 hours. She took extra strength Tylenol after 24 hours and it helped. She asked if she is going to get the same or more severe symptoms because I heard that it is worse with the second dose and if she is not able to take her second dose in 21 days, because they are having an outbreak there, how long should it be before she should get the second dose. The patient was exposed to covid last Saturday and she was only exposed for about 7 hours. The patient's friend tested positive 2 weeks after the vaccine. And received the vaccine on the same day as the patient. The reporter also wants to know how long to wait to get the second dose if you test positive for covid after the first dose. The outcome of the events were recovered on 17Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pain
Clinical narrative: Body ache; This morning I was like short of breath; This is a spontaneous report from a contactable consumer. A 50-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number and expiration date were not reported), via an unspecified route of administration on 25Mar2021 (at the 50-years-old) at unknown dose number single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced body ache, short of breath on 25Mar2021. She wanted to know if she could take any Tylenol or Aspirin or other medicines. The outcome of the events was unknown.  No Follow up attempts are possible, information about lot/batch number cannot be obtained.