chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dermatitis contact, Fatigue, Vaccination site erythema, Vaccination site rash, Vaccination site swelling
Clinical narrative: arm was slightly swollen; rash around the injection site; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284, expiry date: unknown), via an unspecified route of administration on 02Jan2021 08:00 at a single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient noticed her arm was sore a few hours after vaccination on 02Jan2021. Yesterday on 03Jan2021, her arm was sore. On 04Jan2021, when getting dressed she noticed her arm was slightly swollen and there's a rash around the injection site. Outcome of the events was unknown.
Age: 77.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity, Peripheral swelling, Vaccination site rash
Clinical narrative: arm was slightly swollen; rash around the injection site; Arm soreness; This is a spontaneous report from a contactable consumer (patient). A 77-year-old female patient started to receive BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL1284, expiry date: unknown), via an unspecified route of administration on 02Jan2021 08:00 at a single dose for COVID-19 immunisation. There were no medical history and concomitant medications. The patient noticed her arm was sore a few hours after vaccination on 02Jan2021. Yesterday on 03Jan2021, her arm was sore. On 04Jan2021, when getting dressed she noticed her arm was slightly swollen and there's a rash around the injection site. Outcome of the events was unknown.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Rash maculo-papular, Rash vesicular, Skin lesion
Clinical narrative: lesions emerged on right flexar surface of forearm, then left extensor surfaces of thumb, digits 4-5.; assymetric maculopapular rash, starting C6 midline posterior cervical skin (2x3cm circular red raised plaque with vesicles in middle)/On 04Jan2021, noted similar maculopapular rash; Vesicles firm on day 1, intensly pruitic, then broke with clear serosanguinous drainage and healing; This is a spontaneous report from a contactable physician.  A 36-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EH9899), via an unspecified route of administration on 17Dec2020 17:15 at, single dose at left arm for COVID-19 immunization.  Medical history included seasonal allergy from an unknown date and unknown if ongoing.  Concomitant medications included methylcellulose (CITRUCEL), and ibuprofen. On 30Dec2020, it was noted the patient had assymetric maculopapular rash, starting C6 midline posterior cervical skin (2x3cm circular red raised plaque with vesicles in middle). Vesicles firm on day 1, intensly pruitic, then broke with clear serosanguinous drainage and healing. On 31Dec2020, lesions emerged on right flexar surface of forearm, then left extensor surfaces of thumb, digits 4-5. On 04Jan2021, noted similar maculopapular rash on lateral waist lines. No history of atopy, allergies, asthma, or any diseases whatsoever. No history of rash. No new irritants, animals, household products, foods etc. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Paraesthesia
Clinical narrative: metallic taste in the mouth; tingling sensation; This is a spontaneous report from a contactable nurse. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, via an unspecified route of administration on 22Dec2020 at single dose for covid-19 immunisation. Medical history included covid-19 from Jun2020 to an unknown date. The patient's concomitant medications were not reported. The patient received covid vaccine on 22Dec2020 and noticed around 4 days after (26Dec2020) had a metallic taste in the mouth and tingling sensation (persists until now), which according to her were similar to her symptoms when she had covid back in June. She was wondering if she can get the second dose of the vaccine which would probably be stronger. The outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: his regular COVID test came back positive; his regular COVID test came back positive; This is a spontaneous report from a contactable nurse (reporting for himself) from a Pfizer-sponsored program. A 48-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported) via an unspecified route of administration, on 23Dec2020, single dose for COVID-19 immunization. Relevant medical history and concomitant medications were not reported. On 23Dec2020, the patient received the COVID vaccine. On 28Dec2020, he had a negative rapid COVID test, and then on 01Jan2021 his regular COVID test came back positive. The patient would like to see if he should still get the second dose of the vaccine. Outcome of the events was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 cannot be excluded for the reported event SARS-CoV-2 test positive based on the known safety profile. However given the short duration of 9 days since the vaccine first dose, it is unlikely patient would have fully developed immunity.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for covid "yesterday"/asymptomatic; tested positive for covid "yesterday"/asymptomatic; This is a spontaneous report from a contactable nurse (patient). A female patient of an unspecified age received 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 21Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received the first dose of the vaccine on 21Dec2020 and was scheduled for the second on 11Jan2021. The patient tested positive for COVID yesterday, 03Jan2021 and wanted to know what to do about her second dose. The patient added that she was asymptomatic at this point and not taking any medications. Outcome of the events was unknown. The events was assessed as non-serious.  Information on the lot/batch number has been requested.; Sender's Comments: The reported positive test with Covid-19 after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Hyperhidrosis, Influenza like illness, Pain
Clinical narrative: Flu like symptoms; Low grade fever; Chills; body aches; sweating; fatigue; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 41-year-old male patient received BNT162B2 (lot ej1685) intramuscular on 29Dec2020 07:15 AM at a single dose on the left arm as COVID-19 vaccine. Medical history and concomitant medications were not reported. The patient had known allergies to sulfamethoxazole/trimethoprim (SEPTRA). The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). He did not receive other vaccines within four weeks prior to the COVID vaccine. The patient experienced flu like symptoms, low grade fever, chills, body aches, sweating, fatigue, all on 30Dec2020 12:00. The events were non-serious which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the events. He was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on 30Dec2020.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Flu like symptoms; Low grade fever; Chills; body aches; sweating; fatigue; This is a spontaneous report from a contactable other healthcare professional (HCP) (patient). A 41-year-old male patient received BNT162B2 (lot ej1685) intramuscular on 29Dec2020 07:15 AM at a single dose on the left arm as COVID-19 vaccine. Medical history and concomitant medications were not reported. The patient had known allergies to sulfamethoxazole/trimethoprim (SEPTRA). The patient was vaccinated in a hospital (facility where the most recent COVID-19 vaccine was administered). He did not receive other vaccines within four weeks prior to the COVID vaccine. The patient experienced flu like symptoms, low grade fever, chills, body aches, sweating, fatigue, all on 30Dec2020 12:00. The events were non-serious which did not result in death, not life threatening, did not caused/prolonged hospitalization, not disabling/incapacitating, did not cause congenital anomaly/birth defect. Treatment was not received for the events. He was not diagnosed with COVID-19 prior to vaccination and had not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on 30Dec2020.
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: severe anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 6 patients. This is the first of 6 reports.    A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration from an unspecified date at a single dose for vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced severe anaphylaxis, on an unspecified date. Outcome of the event was unknown.    No follow up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003208 different patient/same drug/event;US-PFIZER INC-2021003209 different patient/same drug/event;US-PFIZER INC-2021003210 different patient/same drug/event;US-PFIZER INC-2021003211 different patient/same drug/event;US-PFIZER INC-2021003212 different patient/same drug/event
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for six patients. This is third of six reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported) via an unspecified route of administration on an unspecified date at a single dose as vaccination. Medical history and concomitant medications were not reported. The patient experienced severe anaphylaxis with vaccination on an unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003207 same drug/event and different patients
Sex: U
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: severe anaphylaxis; This is a spontaneous report from a non-contactable consumer. This consumer reported similar events for 6 patients. This is 4th of six reports.   A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date not reported), via an unspecified route of administration on an unspecified date at a single dose for vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced severe anaphylaxis with vaccination on an unspecified date. Outcome of the event was unknown.  No follow up attempts are possible; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021003207 same drug/event and different patients
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mild to moderate injection site soreness 48 hours; This is a spontaneous report from a non-contactable other hcp. A 30-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number and expiry date unknown, via an unspecified route of administration on 30Dec2020 19:30 at single dose for covid-19 immunisation. Medical history included rubber sensitivity from an unknown date and unknown if ongoing. Concomitant medication included amitriptyline (AMITRIPTYLINE), fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and colecalciferol (VITAMIN D [COLECALCIFEROL]). The patient experienced mild to moderate injection site soreness for 48 hours (non-serious) on 30Dec2020 20:00 with outcome of recovered.   No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Muscle spasms, Myalgia, Neck pain, Vaccination site pain
Clinical narrative: severe neck pain; muscle pain that was almost like a horse in the muscles above her hips and in her back; muscle pain that was almost like a horse in the muscles above her hips and in her back; muscle cramping; pain in her arm; This is a spontaneous report from a contactable consumer. A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number 5K5730/expiration date unknown), dose number 1, via an unspecified route of administration on 18Dec2020 at a single dose on the left arm for COVID Prevention. The patient had no relevant medical history. Historical vaccine included flu vaccine for immunisation which caused arm pain. The patient had no concomitant medications. She had no other vaccines on the same day as the COVID vaccine. The patient received her first dose of the COVID vaccine on 18Dec2020, and at first, she just had pain in her arm. It started getting sore in the evening of 18Dec2020. She suspected that would happen, because she gets that with the flu shot too. A few days after receiving the vaccine, she had pretty severe neck pain, and at first she just thought that maybe she slept wrong, but she still had neck pain. She was sitting with hand warmer packs on her neck because the pain was at the point bad enough that she could barely turn her neck. She experienced muscle pain that was almost like a horse in the muscles above her hips and in her back. The pain in her hips and back is bad enough that it almost takes her down. The patient also experienced muscle cramping. She further stated that she had not done anything different; she did not got to the gym. She remembered that when she signed off to get the vaccine, there was something about not taking the vaccine if someone had ever had a side effect to a lipid. The outcome of the events was recovered on 20Dec2020 for pain in her arm, recovering for neck pain, not recovered for muscle pain that was almost like a horse in the muscles above her hips and in her back, unknown for muscle cramping.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Lymphadenopathy, Malaise, Myalgia
Clinical narrative: lymphadenopathy; chills; tachycardia; weakness; feeling unwell; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; fever that reach 101.5F; injection site pain; myalgia in the entire left arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 30Dec2020 18:00 at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). Patient was diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient was not pregnant at the time for vaccination. Concomitant medication included metformin, ergocalciferol (VIT D), and tretinoin cream. Right after injection, the patient had injection site pain and myalgia in the entire left arm on 30Dec2020. The second day, 31Dec2020, about 19 hours after receiving the vaccine, patient started feeling unwell. The injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches on 30Dec2020. Patient developed a fever that reach 101.5F on 30Dec2020. She also experienced chills, tachycardia, and weakness about 24hours after injection on 31Dec2020. Patient experienced lymphadenopathy during the 3rd (01Jan2021) and 4th day (02Jan2021). Patient recovered with lasting effects (recovered with sequel). TYLENOL was received as treatment for the events except for lymphadenopathy. The reporter considered the events non-serious.  Information on the Lot/Batch Number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tachycardia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: lymphadenopathy; chills; tachycardia; weakness; feeling unwell; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; fever that reach 101.5F; injection site pain; myalgia in the entire left arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 30Dec2020 18:00 at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). Patient was diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient was not pregnant at the time for vaccination. Concomitant medication included metformin, ergocalciferol (VIT D), and tretinoin cream. Right after injection, the patient had injection site pain and myalgia in the entire left arm on 30Dec2020. The second day, 31Dec2020, about 19 hours after receiving the vaccine, patient started feeling unwell. The injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches on 30Dec2020. Patient developed a fever that reach 101.5F on 30Dec2020. She also experienced chills, tachycardia, and weakness about 24hours after injection on 31Dec2020. Patient experienced lymphadenopathy during the 3rd (01Jan2021) and 4th day (02Jan2021). Patient recovered with lasting effects (recovered with sequel). TYLENOL was received as treatment for the events except for lymphadenopathy. The reporter considered the events non-serious.  Information on the Lot/Batch Number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: lymphadenopathy; chills; tachycardia; weakness; feeling unwell; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches; fever that reach 101.5F; injection site pain; myalgia in the entire left arm; This is a spontaneous report from a contactable healthcare professional (patient). A 27-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date were unknown), via an unspecified route of administration on the left arm on 30Dec2020 18:00 at single dose for COVID-19 immunization. Medical history included polycystic ovarian syndrome (PCOS). Patient was diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient was not pregnant at the time for vaccination. Concomitant medication included metformin, ergocalciferol (VIT D), and tretinoin cream. Right after injection, the patient had injection site pain and myalgia in the entire left arm on 30Dec2020. The second day, 31Dec2020, about 19 hours after receiving the vaccine, patient started feeling unwell. The injection site was red, swollen, painful, and hot to the touch with a diameter of about 2inches on 30Dec2020. Patient developed a fever that reach 101.5F on 30Dec2020. She also experienced chills, tachycardia, and weakness about 24hours after injection on 31Dec2020. Patient experienced lymphadenopathy during the 3rd (01Jan2021) and 4th day (02Jan2021). Patient recovered with lasting effects (recovered with sequel). TYLENOL was received as treatment for the events except for lymphadenopathy. The reporter considered the events non-serious.  Information on the Lot/Batch Number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site hypoaesthesia, Vaccination site paraesthesia
Clinical narrative: tingling and numbness in the injection arm (left arm); tingling and numbness in the injection arm (left arm); This is a spontaneous report from a contactable nurse (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1086, expiration date: Mar2021), via an unspecified route of administration in the left arm on 04Jan2021 at a single dose for COVID-19 immunization. There were no medical history and concomitant medications. On 04Jan2021, the patient received the COVID vaccine 30 minutes ago then the patient started having tingling and numbness in the injection arm (left arm). She wanted to know if this has been reported and how long will it last. Outcome of the events was not recovered.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Cough, Swelling
Clinical narrative: Soreness at and around the injection site on the right upper arm; Coughing; tenderness in the axillary region of the right arm; slight swelling in the axillary region of the right arm; This is a spontaneous report from a contactable healthcare professional (patient herself). A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1686, expiry date not reported), via an unspecified route of administration on the right arm on 31Dec2020 09:15 at single dose for COVID-19 immunization. Medical history included biliary dyskinesia from an unknown date and unknown if ongoing, and cholecystectomy (gallbladder surgically removed Nov2019), irritable bowel syndrome subtype C (diagnosed Jul2020), and COVID-19 on an unspecified date prior vaccination. Concomitant medications included polyethylene glycol [macrogol] and amitriptyline. The patient experienced soreness at and around the injection site on the right upper arm on 01Jan2021 10:00; tenderness in the axillary region of the right arm on Jan2021; slight swelling in the axillary region of the right arm on Jan2021; and coughing on 01Jan2021 10:00. No therapeutic measure was taken as a result of the events. Clinical outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Paraesthesia, Vaccination site pain
Clinical narrative: Prickling needles feeling soles feet bilaterally and some in palms hands; pain in hip joints; moderate leg aches bilaterally; Sore arm at injection site; This is a spontaneous report from a non-contactable nurse (patient). A 47-year-old female patient received first dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EJ1685), via an unspecified route of administration in the right arm, on 30Dec2020 at a single dose for COVID-19 immunization. The patient was 47 years old when she received the vaccine. Medical history included RSD (Reflex sympathetic dystrophy), had allergies to medications, food, or other product particularly NSAID and to contrast dye. The patient is not pregnant. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient was not diagnosed with Covid-19 prior to vaccination. She had not been tested for Covid-19 since vaccination. The patient had sore arm at injection site for 36 hours after administration (02Jan2021) with outcome of recovered in Jan2021. In day #4 (03Jan2021), she had pain in hip joints and moderate leg aches bilaterally with outcome of unknown. In day #5 (04Jan2021), she had prickling needles feeling soles feet bilaterally and some in the palms of her hands with outcome of unknown. The events were reported as non-serious.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: severe headache; muscle pain; This is a spontaneous report from a non-contactable consumer. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. On an unspecified date, the patient experienced severe headache and muscle pain. The reporter was asking if she should get her second dose of vaccine if she had experienced severe headache and muscle pain. Clinical outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Exposure to SARS-CoV-2, SARS-CoV-2 test positive
Clinical narrative: diagnosed with COVID-19; diagnosed with COVID-19; This is a spontaneous report from a contactable nurse.  A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were not reported), via an unspecified route of administration on 19Dec2020 at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient stated, "I received the first dose of the COVID-19 vaccine last 19Dec2020 and unfortunately was exposed to COVID-19 in the evening. I was diagnosed with COVID-19 on 22Dec2020 or 23Dec2020. Should I have my second dose as scheduled tomorrow considering that I have the COVID-19?". The outcome of the event was unknown.   Information on lot number has been requested.; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product bnt162b2 to the reported drug ineffective and COVID-19 cannot be ruled out.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Phlebitis, Pruritus
Clinical narrative: Headache; Itchiness; Phlebitis; Looks like little flea bites on her skin. There isn't that many, its mostly on her upper torso and they are sporadically placed.; This is a spontaneous report from a contactable nurse (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL0140; Expiration date was not reported), intramuscularly on the right deltoid, on 27Dec2020 (10:00) at a single dose for COVID-19 immunization at the hospital. Medical history included hypertension; hypothyroidism; was allergic to shellfish probably over the last 20 or 30 years; and was allergic to penicillin and sulfa "many, many years ago". Concomitant medications included HCTZ for hypertension; losartan potassium (COZAAR) for hypertension; levothyroxine sodium (SYNTHROID) for hypothyroidism; amlodipine for hypertension; omeprazole for hypertension; and ongoing lansoprazole (PREVACID). The patient previously took Fluzone Quadrivalent influenza vaccine on 17Oct2020 for vaccination, and had itchiness. On 28Dec2020, the patient had headache; itchiness; phlebitis; and had what looked like flea bites on her skin which were not that many, and was mostly on the upper torso and sporadically placed. The patient had received diphenhydramine (BENADRYL) as treatment for the events. The patient was told that since itchiness was not a part of the normal side effects, the itchiness was considered an adverse reaction and that she could not get her second shot which was scheduled for 16Jan2021. The outcome of the events was recovering for 'headache', 'pruritus' and 'phlebitis'; and was recovered on an unspecified date for 'looked like flea bites on her skin'.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, SARS-CoV-2 test
Clinical narrative: Nausea and headache still exist Day 6; Nausea and headache still exist Day 6; This is a spontaneous report from a non-contactable other healthcare professional. An adult female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284; expiry date: unknown) intramuscular (arm left) on 30Dec2020 at 11:00, at a single dose, for COVID-19 immunization. Relevant medical history included unspecified allergies. Concomitant medications were not reported. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient showed a negative result on 17Dec2020. The patient did not receive other vaccines within four weeks prior to COVID vaccination. The vaccine was administered at patient's workplace (clinic). On 30Dec2020, at 15:00, the patient experienced nausea and headache which still exist until day 6. The patient did not receive treatment for the events. Outcome of the events was not recovered. The patient has been tested post vaccination; however the results were unspecified.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Nausea
Clinical narrative: Swollen stiff arm at the site of the injection; Swollen stiff arm at the site of the injection; Nausea; Diarrhea; shivering; Sweating; Body ache; This is a spontaneous report from a contactable physician (patient). A 61-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: PFL72TRA9899), intramuscular in left arm, on 31Dec2020 at 07:00, at a single dose, for COVID-19 immunization. The patient's medical history included COVID-19 (diagnosed prior to vaccination). There were no concomitant medications. The patient had no known allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The most recent COVID-19 vaccine was administered in a hospital. On 31Dec2020 at 8 PM (also reported as after exactly 12 hours; possibly discrepant), the patient experienced swollen stiff arm at the site of the injection, severe episode of nausea, diarrhea, shivering, sweating, and severe body ache. Treatment received for the adverse events included paracetamol (TYLENOL). The events were considered non-serious. Since the vaccination, the patient has not been tested for COVID-19. The patient was recovering from the events.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Malaise, Vaccination site pain
Clinical narrative: mild pain at the injection site; tiredness; chills; headache; feeling unwell; This is a spontaneous report from a contactable nurse (patient). A 53-year-old female patient received bnt162b2 (BNT162B2; Pfizer-Biontech Covid-19 Vaccine also reported as vaccine A (Pfizer Ultracold); lot number: EH9899; expiration date: unknown), via an unspecified route of administration left arm on 22Dec2020 09:15 at a single dose for covid-19 vaccination. Medical history included anxiety and depression. The patient has no allergies to medications, food, or other products. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had other medications received within 2 weeks of vaccination. The patient most recent COVID-19 vaccine was administered a hospital. It was reported that 7 hours after vaccination (22Dec2020 04:15 PM [reported as 04:00PM]), the patient experienced mild pain at the injection site, tiredness, chills, headache, and feeling unwell. All resolved within 12 hours after sleep (23Dec2020 04:15). The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was recovered on 23Dec2020 04:15.
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: her arm started tingling/she was getting some tingling in her feet/getting all the sporadic tingling; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration, on 28Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. It was unknown if patient is pregnant at the of vaccination, if patient was diagnosed with COVID prior vaccination, and if patient received other vaccines within four weeks prior to COVID vaccination. The patient received Pfizer COVID vaccine last Monday and a few hours afterwards her arm started tingling. A few days later she was getting some tingling in her feet and she's getting all the sporadic tingling that is not going away. She's not even sure if she should get the second shot of the vaccine. Outcome of the event was not recovered. It was unknown if patient has been tested for COVID-19 since vaccination.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphoedema, Swelling
Clinical narrative: swelling is radiating to her exterior chest and the area hurts at touch; swelling is radiating to her exterior chest and the area hurts at touch; headache; body ache; swelling of the lymph nodes; lymphoedema; This is a spontaneous report from a nurse Medical information team. A female patient of an unspecified age (Age: 85; units: unknown) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 18Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient had headache and body ache next day after receiving the Pfizer COVID-19 vaccine. On 31Dec2020, the patient reported lymphoedema or swelling of the lymph nodes. The swelling was radiating to her exterior chest and the area hurts at touch. The patient received the first dose of Pfizer COVID-19 vaccine on the 18Dec2020. The nurse wanted to know if the patient can receive the second dose of Pizer Covid-19 vaccine despite her symptoms. The outcome of the events was unknown.  Information on Lot/Batch number has been requested
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Facial pain, Swelling face
Clinical narrative: Approximately 3 days later noticed facial swelling at the site of prior facial filler injection -  around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; Approximately 3 days later noticed facial swelling at the site of prior facial filler injection -  around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; Approximately 3 days later noticed facial swelling at the site of prior facial filler injection -  around nasolabial folds and tear trough areas/minimal erythema and tenderness only on palpation; This is a spontaneous report from a contactable physician (patient herself). A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were unknown) via an unspecified route of administration (arm left), on 19Dec2020, at a single dose, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received facial filler Restylane, which was injected in Sep2019. The patient is not pregnant at the time of vaccination. The patient was not diagnosed with COVID prior vaccination. The patient did not receive other vaccines within two to four weeks prior to COVID vaccination. On 22Dec2020, approximately 3 days after vaccination, patient noticed facial swelling at the site of prior facial filler injection - around nasolabial folds and tear trough areas. There was minimal erythema and tenderness only on palpation. The events resolved approximately 3-4 days later (unspecified date in Dec2020). The events did not require intervention/treatment. Outcome of the events was recovered.  Information on the lot/batch number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose abnormal, Diarrhoea, Urticaria
Clinical narrative: hard time keeping blood sugar up; diarrhea; Hives; This is a spontaneous report from a contactable nurse (patient's sister). A 39-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: expiry date: unknown) via an unspecified route of administration, in Dec2020, at a single dose, for COVID-19 immunization. Medical history included diabetic. The patient's concomitant medications were not reported. Registered nurse called regarding COVID-19 vaccine. Her sister who is also a nurse got the vaccine before she did sometime in Dec2020. About 18 hours after receiving the COVID 19 vaccine, her sister got diarrhea and was having a hard time keeping her blood sugar up. The patient did not receive treatment for events diarrhea or the blood sugar. Patient also experienced hives and used Benadryl as treatment. Nurse stated that she has not talked to her; unsure if all of these events resolved or not but thinks the diarrhea was better. Outcome of the event diarrhea was recovering, while for other events was unknown. Seriousness of the events was not provided.  No further information is provided. Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Peripheral swelling
Clinical narrative: right hand swelled and both feet and ankles; right hand swelled and both feet and ankles; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (BNT162B2), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunisation. Medical history included COVID through the end of Oct and Nov020. The patient's concomitant medications were not reported. The patient stated that her hospital would like for her to receive the Pfizer vaccine and she was told that it would boost her antibodies. She received the COVID vaccine on Friday, 18Dec2020. Afterwards, on an unspecified day in Dec2020, her right hand swelled and both feet and ankles. She called the nurse and was instructed to take Benadryl. She took the Benadryl for two days and then called her family practice physician who prescribed her a prednisone pack which helped with the swelling. The patient would like to know if she should receive the second shot, how effective the first dose would be if she doesn't receive the second shot, and what the interval is for the second dose of the Covid vaccine. Outcome of the event was recovering.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Chills, Fatigue, Peripheral swelling, Pyrexia
Clinical narrative: right hand swelled and both feet and ankles; right hand swelled and both feet and ankles; This is a spontaneous report from a contactable consumer (patient). A 65-year-old female patient received BNT162B2 (BNT162B2), via an unspecified route of administration on 18Dec2020 at a single dose for COVID-19 immunisation. Medical history included COVID through the end of Oct and Nov020. The patient's concomitant medications were not reported. The patient stated that her hospital would like for her to receive the Pfizer vaccine and she was told that it would boost her antibodies. She received the COVID vaccine on Friday, 18Dec2020. Afterwards, on an unspecified day in Dec2020, her right hand swelled and both feet and ankles. She called the nurse and was instructed to take Benadryl. She took the Benadryl for two days and then called her family practice physician who prescribed her a prednisone pack which helped with the swelling. The patient would like to know if she should receive the second shot, how effective the first dose would be if she doesn't receive the second shot, and what the interval is for the second dose of the Covid vaccine. Outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Tested positive for covid a week later after his first shot; Tested positive for covid a week later after his first shot; This is a spontaneous report from a contactable consumer. A 68-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration in the left arm on 28Dec2020 at 12:00 PM in a hospital at a single dose as a COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient had no known allergies but had other medical history (unspecified). The patient did not receive any other vaccine within four weeks prior to the COVID vaccine, had other medications in two weeks (unspecified), and was not diagnosed with COVID-19 prior to the vaccination. The patient tested positive for COVID a week later after his first shot. The test used was via nasal swab on 04Jan2021. The patient did not receive any treatment for the events. Outcome of the events was reported as recovering. The case was reported as non-serious (did not result in death, was not life-threatening, did not cause/prolong hospitalization, was not disabling/incapacitating, and did not result to any congenital anomaly/birth defect).  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Patient received Positive Covid 19 test result on 02Jan2021; Patient received Positive Covid 19 test result on 02Jan2021; This is a spontaneous report from contactable consumers. An adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: IL0140), via an unspecified route of administration on 28Dec2020 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received positive COVID 19 test result on 02Jan2021. The patient had unknown test with positive result on 31Dec2020. The case was identified as non-serious by reporter. Facility where the most recent COVID-19 vaccine was administered was in hospital. It was unknown that the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown that the treatment received for the adverse event. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, the patient had been tested for COVID-19. The outcome of event was recovering.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: body aches; running a fever; This is a spontaneous report from a contactable consumer (patient). A 32-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EH9899), via an unspecified route of administration on 03Jan2021 at 12:30 at a single dose as a Covid vaccine. Medical history included bariatric surgery three months ago. He used to have high blood pressure, but after the surgery his blood pressure went away. Concomitant medications included multivitamins and calcium to keep himself healthy. On 04Jan2021, the patient was running a fever which started at 10:30 AM and he was concerned about going to work with the fever. He also had body aches on an unspecified date, but that could be because he went hiking for three days in a row. He told his boss, but said it could be because he went hiking. The patient clarified that he works from home and at the clinic. He didn't know if he should go. He was asking if it's ok to go to work. He was taking his temperature with two different things. It was reported that his temperature was 99.7 degrees Fahrenheit. Outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia
Clinical narrative: lost her sense of smell and taste; lost her sense of smell and taste; This is a spontaneous report from a non-contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine), via an unspecified route of administration on 04Jan2021 at a single dose as COVID vaccine. The patient's medical history and concomitant medications were not reported. The patient stated that after she got the vaccine today (04Jan2021), she lost her sense of smell and taste. She asked if she can still get the vaccine and if it was normal. Outcome of the events was unknown. The case was reported as non-serious.  No follow-up attempts are possible, information about the lot/batch cannot be obtained.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Right shoulder pain; This is a spontaneous report from a contactable consumer (patient). A 25-year-old male patient received the first dose of BNT162B2 (Pfizer-BIONTECH Covid-19 Vaccine; Lot number: EJ1685), via an unspecified route of administration in the left deltoid on 22Dec2020 at a single dose as preventative and to protect the people around him. The patient had no relevant medical history and no concomitant medications. The patient stated that ever since he got the vaccine, he has had shoulder pain (onset date was on 24Dec2020). He was unsure if it was joint or muscular. When he raises it to a certain level, there was intense pain. This was only his right shoulder, he got the vaccine on his left side. The pain had stayed the same. It goes away every so often and then it comes back, that was with him helping it. He had used heat, taking Advil, and sometimes icing it. It had stayed the same and it has not gone away and it has not improved. The patient thinks his dose was 3mL, if he can recall. He stated that he did have one question. He was about to resume classes at his college and they were requesting that he took a tetanus shot and get a TB skin test. He was trying to figure out if that was okay. He remembers reading something that he should not get another vaccine at this time. If that was true, the patient was inquiring what was the time span. Outcome of the event was not recovered/not resolved.
Sex: M
Vaccine: PNC13
Symptoms: Asthma, Cough
Clinical narrative: Asthma; cough; This is a spontaneous report from a contactable consumer. A currently 73-year-old received the vaccine at 67 or 68 years old, pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein (PREVNAR 13, lot number: unknown), via an unspecified route of administration in 2013 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The reported stated that back in 2013, his brother took the vaccine and within a year and half after he took it he developed asthma, also stated that neither one of them smoke or drink alcohol, seems there possibly seems to be a connection between the DNA. The reported added that his brother is now he is on maximum steroid for the treatment of it, has a cough that is just terrible, pulmonary specialist cannot seem to figure it out. The outcome of events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.