chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Formication, Pain, Pruritus, Rash
Clinical narrative: severe itching and pain; severe itching and pain; developed a rash on my back; stomach felt like fire ants were crawling and biting me; stomach felt like fire ants were crawling and biting me; This is a spontaneous report from a contactable other healthcare professional (patient). A 32-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL3246) via an unspecified route of administration on the left arm on 21Jan2021 13:00 at a single dose for COVID-19 immunization. Medical history included diabetes, asthma and known allergies: neutrogena products. Concomitant medication included metformin and ibuprofen (ADVIL [IBUPROFEN]). On 22Jan2021 01:20 am the patient woke up from severe itching and pain. The patient had developed a rash on her back and stomach felt like fire ants were crawling and biting her. The only thing that came to her mind was taking an oral antihistamine so she took diphenhydramine (BENADRYL), the rash and itching was gone in the morning on Friday she had a discussion with the physician she worked with to let him know what had happened, to get his opinion on if she should get the 2nd vaccine. She took another diphenhydramine the Friday night just in case no itching didn't take diphenhydramine on Saturday however the itching returned on Sunday the late afternoon approx at 4pm took another diphenhydramine but still feeling a little itching the back and stomach (no new foods lotions soaps or supplements were started so it had to be the vaccine). The facility where the vaccine was administered was in a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Prior to vaccination, the patient was not diagnosed with COVID-19. Post vaccination, the patient has not been tested for COVID-19. Outcome of the events was recovering.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Malaise, Nausea
Clinical narrative: feeling unwell; Chills; extreme body aches; joint pain; headache; nausea; fever; injection site swelling/redness/pain; injection site swelling/redness/pain; injection site swelling/redness/pain; This is a spontaneous report from a contactable other hcp.   A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 22Jan2021 16:15 for covid-19 immunisation. Medical history included hypothyroidism, drug hypersensitivity to penicillin, ceclor, bactrim, covid-19. Concomitant medications included letrozole, levothyroxine. No other vaccine was received in four weeks.  The patient experienced feeling unwell on 23Jan2021 13:30, chills on 23Jan2021 13:30, extreme body aches on 23Jan2021 13:30, joint pain on 23Jan2021 13:30, headache on 23Jan2021 13:30, nausea on 23Jan2021 13:30, fever on 23Jan2021 13:30, injection site swelling/redness/pain on 23Jan2021 13:30. No treatment received. The outcome was recovering. Information on the Lot/Batch Number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: feeling unwell; Chills; extreme body aches; joint pain; headache; nausea; fever; injection site swelling/redness/pain; injection site swelling/redness/pain; injection site swelling/redness/pain; This is a spontaneous report from a contactable other hcp.   A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration arm left single dose on 22Jan2021 16:15 for covid-19 immunisation. Medical history included hypothyroidism, drug hypersensitivity to penicillin, ceclor, bactrim, covid-19. Concomitant medications included letrozole, levothyroxine. No other vaccine was received in four weeks.  The patient experienced feeling unwell on 23Jan2021 13:30, chills on 23Jan2021 13:30, extreme body aches on 23Jan2021 13:30, joint pain on 23Jan2021 13:30, headache on 23Jan2021 13:30, nausea on 23Jan2021 13:30, fever on 23Jan2021 13:30, injection site swelling/redness/pain on 23Jan2021 13:30. No treatment received. The outcome was recovering. Information on the Lot/Batch Number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Difficult breathing; Started getting pins/needles/tingling/pain on both of my hands; Started getting pins/needles/tingling/pain on both of my hands/Pins/needles/tingling/pain throughout my body; Chest tightened; Pins/needles/tingling/pain throughout my body; This is a spontaneous report from a contactable pharmacist (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at the left arm on 22Jan2021 13:45 at single dose for COVID-19 immunization. Medical history included birth control. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included ethinylestradiol, levonorgestrel (LEVORA) for birth control. The patient previously took the first doe of BNT162B2 on 31Dec2020 administered at the left arm. The patient got the vaccination on 22Jan2021 and in less than 5 minutes she started getting pins/needles/tingling/pain on both of my hands. Then suddenly her chest tightened and had difficult breathing which lasted for 2-3 mins. Now (22Jan2021), she has pins/needles/tingling/pain throughout her body. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the events. The patient underwent lab tests and procedures which included Nasal Swab and SARS-CoV-2, RT-PCR on 21Jan2021 and both are negative. The outcome of the event general body pain was unknown and recovered for the rest of the events.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Difficult breathing; Started getting pins/needles/tingling/pain on both of my hands; Started getting pins/needles/tingling/pain on both of my hands/Pins/needles/tingling/pain throughout my body; Chest tightened; Pins/needles/tingling/pain throughout my body; This is a spontaneous report from a contactable pharmacist (patient). A 32-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3302), via an unspecified route of administration at the left arm on 22Jan2021 13:45 at single dose for COVID-19 immunization. Medical history included birth control. The patient has no known allergies. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. Concomitant medication included ethinylestradiol, levonorgestrel (LEVORA) for birth control. The patient previously took the first doe of BNT162B2 on 31Dec2020 administered at the left arm. The patient got the vaccination on 22Jan2021 and in less than 5 minutes she started getting pins/needles/tingling/pain on both of my hands. Then suddenly her chest tightened and had difficult breathing which lasted for 2-3 mins. Now (22Jan2021), she has pins/needles/tingling/pain throughout her body. The events resulted in doctor or other healthcare professional office/clinic visit. It was unknown if the patient received treatment for the events. The patient underwent lab tests and procedures which included Nasal Swab and SARS-CoV-2, RT-PCR on 21Jan2021 and both are negative. The outcome of the event general body pain was unknown and recovered for the rest of the events.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Myalgia, Paraesthesia, Sensory disturbance
Clinical narrative: Muscle pain left arm 20 hours; Left foot felt like electric shock, vibrated and was stiff and out of control for 7 times; Left foot felt like electric shock, vibrated and was stiff and out of control for 7 times; Left foot felt like electric shock, vibrated and was stiff and out of control for 7 times; This is a spontaneous report from a contactable healthcare professional (patient). A 67-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: E19262 and expiry date: unknown), via an unspecified route of administration on the left arm, on 21Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included peanut allergy. Patient was not pregnant at the time if vaccination. There were no concomitant medications. The patient experienced muscle pain left arm for 20 hours. Pain in arm muscle only when moving arm. Her left foot felt like electric shock, vibrated and was stiff and out of control for 7 times during same time as arm pain. Each episode lasting only 2 to 3 seconds. The events happened on 21Jan2021 12:00. Patient recovered from the events and had not received any treatment. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Rhinorrhoea, Vaccination site pain
Clinical narrative: runny nose with thin mucous; muscle pain in right arm; muscle pain in right arm; This is a spontaneous report from a contactable consumer (patient). A 51-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9263) solution for injection, via an unspecified route of administration in right arm on 22Jan2021 11:00 at a single dose for Covid-19 immunization. Medical history included diabetes and chronic kidney disease. Concomitant medications included calcitriol, fluoxetine hydrochloride (PROZAC), and labetalol. The patient experienced runny nose with thin mucous and muscle pain in right arm on 23Jan2021. Patient did not received any treatment for the events. Outcome of the events was recovering.  No follow-up activities are needed. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal discomfort
Clinical narrative: Muscle pains in legs like unto a lactic build up; Nose burning when inhaling, especially in cold air; This is a spontaneous report from a contactable consumer (patient). A 71-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), via an unspecified route of administration in the left arm  on 06Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history was None. Concomitant medication included escitalopram, meloxicam (MOBIC), acetylsalicylic acid (ASPIRIN (E.C.) and calcium carbonate, colecalciferol (CALCIUM D3). The patient was not pregnant. She had no other vaccines in four weeks prior covid vaccine. The patient had no covid prior vaccination. She had not tested for covid post vaccination. The patient had no known allergies. The patient experienced nose burning when inhaling, especially in cold air. She had muscle pains in legs like unto a lactic build up. These were still happening after 18 days from injection which are worse at night. The events started on 06Jan2021 at 10: 45 AM with outcome of not recovered. No treatment received for the events.  Information about Batch/Lot number has been requested.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Headache, Pain
Clinical narrative: a lot of body aches; headache; some shortness of breath; This is a spontaneous report from a contactable Other Health Professional (HCP) reported for herself. A 41-year-old female patient (pregnant: no) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via unspecified route of administration on 18Jan2021 at 12:15 at single dose for COVID-19 immunisation. The relevant medical history and concomitant medications were reported as none. The patient previously received first dose of BNT162B2 at the age of 41 years old on 28Dec2020 for COVID-19 immunisation (first dose, via intramuscular, administration time=10:00 AM, vaccine location=Left arm). After the second vaccine starting about 10 hours after it was given, the patient had a lot of body aches, headache, and some shortness of breath on 19Jan2021. No treatment received for the events. No covid prior vaccination. No covid tested post vaccination. No other vaccine in four weeks. No other medications in two weeks. The outcome of the events was recovered on an unspecified date.  Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021067674 maternal, infant cases;US-PFIZER INC-2021068772 maternal, infant cases
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Dry mouth, Enlarged uvula, Feeling hot
Clinical narrative: uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; top back roof of the mouth, uvula and tonsils felt tingly; migraine; light sensitivity; dry mouth; thirst; racing heart; felt very hot; felt dizzy, like how it felt when standing up too quickly, but she was already standing; sharp pain in her shoulder; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included chronic migraines and depression. The patient has no known allergies. Concomitant medication included erenumab aooe (AIMOVIG), clarithromycin (CLARITIN), ibuprofen (IBU), mirtazapine (REMERON), paracetamol (TYLENOL), ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient reported that "about 20 min" after receiving the vaccine, the patient's top back roof of the mouth, uvula and tonsils felt tingly. Then she started having a migraine, with light sensitivity, dry mouth, thirst, racing heart, and felt very hot. For a few seconds she felt dizzy, like how it felt when standing up too quickly, but she was already standing. Simultaneously, she had a sharp pain in her shoulder while she was dizzy. These reactions did not begin to subside until about 4 hours later. All these aforementioned adverse events happened on 31Dec2020 14:00 and the patient recovered from them on an unspecified date with lasting effects (recovered with sequel). After the tingly feeling in her mouth went away, she noticed that her uvula was dropped very low on an unspecified date. It did not look red and it was not sore, but it was so long that it touches her tongue and/or sticks to her tonsils. It has been 3 weeks later and her dropped uvula has not improved or changed. The patient did not recover from the event "uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils". She added that she tried to get her 2nd dose on 22Jan2021, but the clinic and the physician did not feel comfortable with giving her the 2nd dose because they have not heard of any cases of side effects of the tingly mouth/uvula/tonsils and continued dropped uvula. No treatment was received for all the adverse events reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the following Covid tests post-vaccination: via nasal swab on 22Jan2021 with result of negative; via nasal swab with Color on 19Jan2021 with result of negative; via nasal swab on 15Jan2021 with result of negative; via nasal swab with Color on 12Jan2021 with result of negative; via nasal swab with Color on 08Jan2021 with result of negative and; via nasal swab with Color on 06Jan2021 with result of negative.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Palpitations, Paraesthesia oral, Photosensitivity reaction, SARS-CoV-2 test
Clinical narrative: uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; top back roof of the mouth, uvula and tonsils felt tingly; migraine; light sensitivity; dry mouth; thirst; racing heart; felt very hot; felt dizzy, like how it felt when standing up too quickly, but she was already standing; sharp pain in her shoulder; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included chronic migraines and depression. The patient has no known allergies. Concomitant medication included erenumab aooe (AIMOVIG), clarithromycin (CLARITIN), ibuprofen (IBU), mirtazapine (REMERON), paracetamol (TYLENOL), ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient reported that "about 20 min" after receiving the vaccine, the patient's top back roof of the mouth, uvula and tonsils felt tingly. Then she started having a migraine, with light sensitivity, dry mouth, thirst, racing heart, and felt very hot. For a few seconds she felt dizzy, like how it felt when standing up too quickly, but she was already standing. Simultaneously, she had a sharp pain in her shoulder while she was dizzy. These reactions did not begin to subside until about 4 hours later. All these aforementioned adverse events happened on 31Dec2020 14:00 and the patient recovered from them on an unspecified date with lasting effects (recovered with sequel). After the tingly feeling in her mouth went away, she noticed that her uvula was dropped very low on an unspecified date. It did not look red and it was not sore, but it was so long that it touches her tongue and/or sticks to her tonsils. It has been 3 weeks later and her dropped uvula has not improved or changed. The patient did not recover from the event "uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils". She added that she tried to get her 2nd dose on 22Jan2021, but the clinic and the physician did not feel comfortable with giving her the 2nd dose because they have not heard of any cases of side effects of the tingly mouth/uvula/tonsils and continued dropped uvula. No treatment was received for all the adverse events reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the following Covid tests post-vaccination: via nasal swab on 22Jan2021 with result of negative; via nasal swab with Color on 19Jan2021 with result of negative; via nasal swab on 15Jan2021 with result of negative; via nasal swab with Color on 12Jan2021 with result of negative; via nasal swab with Color on 08Jan2021 with result of negative and; via nasal swab with Color on 06Jan2021 with result of negative.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst
Clinical narrative: uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils; top back roof of the mouth, uvula and tonsils felt tingly; migraine; light sensitivity; dry mouth; thirst; racing heart; felt very hot; felt dizzy, like how it felt when standing up too quickly, but she was already standing; sharp pain in her shoulder; This is a spontaneous report from a contactable healthcare professional (patient). A 40-year-old female patient (not pregnant) received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EJ1685), via an unspecified route of administration (left arm), on 31Dec2020 13:30, at single dose, for covid-19 immunization. Medical history included chronic migraines and depression. The patient has no known allergies. Concomitant medication included erenumab aooe (AIMOVIG), clarithromycin (CLARITIN), ibuprofen (IBU), mirtazapine (REMERON), paracetamol (TYLENOL), ascorbic acid (VIT C), and ergocalciferol (VIT D). The patient reported that "about 20 min" after receiving the vaccine, the patient's top back roof of the mouth, uvula and tonsils felt tingly. Then she started having a migraine, with light sensitivity, dry mouth, thirst, racing heart, and felt very hot. For a few seconds she felt dizzy, like how it felt when standing up too quickly, but she was already standing. Simultaneously, she had a sharp pain in her shoulder while she was dizzy. These reactions did not begin to subside until about 4 hours later. All these aforementioned adverse events happened on 31Dec2020 14:00 and the patient recovered from them on an unspecified date with lasting effects (recovered with sequel). After the tingly feeling in her mouth went away, she noticed that her uvula was dropped very low on an unspecified date. It did not look red and it was not sore, but it was so long that it touches her tongue and/or sticks to her tonsils. It has been 3 weeks later and her dropped uvula has not improved or changed. The patient did not recover from the event "uvula was dropped very low/it was so long that it touches her tongue and/or sticks to her tonsils". She added that she tried to get her 2nd dose on 22Jan2021, but the clinic and the physician did not feel comfortable with giving her the 2nd dose because they have not heard of any cases of side effects of the tingly mouth/uvula/tonsils and continued dropped uvula. No treatment was received for all the adverse events reported. The patient did not have COVID prior vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had the following Covid tests post-vaccination: via nasal swab on 22Jan2021 with result of negative; via nasal swab with Color on 19Jan2021 with result of negative; via nasal swab on 15Jan2021 with result of negative; via nasal swab with Color on 12Jan2021 with result of negative; via nasal swab with Color on 08Jan2021 with result of negative and; via nasal swab with Color on 06Jan2021 with result of negative.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Inappropriate schedule of product administration, Lymphadenopathy, Pain
Clinical narrative: The today (day 3) my lymph nodes, under arms, are swollen.; The next day (day 2) I experienced chills and body aches throughout the day; The next day (day 2) I experienced chills and body aches throughout the day; became suddenly tired in the afternoon; first dose was on 22Dec2020 while second dose on 22Jan2021; sore arm within a few hours of getting the shot; This is a spontaneous report from a non-contactable healthcare professional (patient). A 41-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Covid-19 vaccine; lot number: EL 3249; expiration date: unknown), intramuscular left arm on 22Jan2021 15:30 at a single dose for covid-19 immunization. Medical history included allergy to mango and passion fruit and covid prior vaccination. The patient's concomitant medications were not reported. The patient did not have other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as Covid-19 vaccine; lot number: EH 9899) at the age of 41-year-old intramuscular right arm on 22Dec2020 15:30 at a single dose for covid-19 immunization. The patient reported that on her second dose, she had sore arm within a few hours (22Jan2021) of getting the shot. The next day (day 2 [23Jan2021 11:45 AM]), she experienced chills and body aches throughout the day and became suddenly tired in the afternoon. The today [25Jan2021] (also reported as day 3 [24Jan2021]) her lymph nodes under her arms are swollen. As of now (Jan2021), she has no chills, body aches are not as bad, and her left arm isn't as sore, but her lymph nodes are still swollen. It was reported that the treatment was unknown. The patient has not been covid tested post vaccination. The outcome of the event shills was recovered in Jan2021, for the event swollen lymph nodes was not recovered, as for the events pain in arm and ache were recovering, while the outcome of the other events was unknown.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: The today (day 3) my lymph nodes, under arms, are swollen.; The next day (day 2) I experienced chills and body aches throughout the day; The next day (day 2) I experienced chills and body aches throughout the day; became suddenly tired in the afternoon; first dose was on 22Dec2020 while second dose on 22Jan2021; sore arm within a few hours of getting the shot; This is a spontaneous report from a non-contactable healthcare professional (patient). A 41-year-old non-pregnant female patient received her second dose of bnt162b2 (BNT162B2 reported as Covid-19 vaccine; lot number: EL 3249; expiration date: unknown), intramuscular left arm on 22Jan2021 15:30 at a single dose for covid-19 immunization. Medical history included allergy to mango and passion fruit and covid prior vaccination. The patient's concomitant medications were not reported. The patient did not have other vaccine in four weeks. The patient received her first dose of bnt162b2 (BNT162B2 reported as Covid-19 vaccine; lot number: EH 9899) at the age of 41-year-old intramuscular right arm on 22Dec2020 15:30 at a single dose for covid-19 immunization. The patient reported that on her second dose, she had sore arm within a few hours (22Jan2021) of getting the shot. The next day (day 2 [23Jan2021 11:45 AM]), she experienced chills and body aches throughout the day and became suddenly tired in the afternoon. The today [25Jan2021] (also reported as day 3 [24Jan2021]) her lymph nodes under her arms are swollen. As of now (Jan2021), she has no chills, body aches are not as bad, and her left arm isn't as sore, but her lymph nodes are still swollen. It was reported that the treatment was unknown. The patient has not been covid tested post vaccination. The outcome of the event shills was recovered in Jan2021, for the event swollen lymph nodes was not recovered, as for the events pain in arm and ache were recovering, while the outcome of the other events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Back pain, Chills
Clinical narrative: chills on day of site; aches on her back; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender 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. The patient medical history and concomitant medications were not reported. The patient experienced chills on day of site. Took Advil and went away within the hour. Next day (today) aches on her back and hasn't resolved. Event took place after use of product. Therapeutic measures were taken as a result of chills on day of site which included Advil. The outcome of the event chills on day of site was recovered while for aches on her back was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: only mild muscle soreness at injection site; This is a spontaneous report received from a contactable nurse. A 56-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EC324U, expiry date: unknown), via an unspecified route of administration in the left arm, on 11Jan2021 (also reported as 21Jan2021, pending clarification), at single dose, for covid-19 immunization, at the hospital. Medical history included penicillin allergy. The patient was not pregnant at the time of vaccination. Concomitant medication included daily vitamins (other medications in two weeks). The patient did not receive other vaccines in four weeks. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. On 11Jan2021, first dose, the patient only experienced mild muscle soreness at injection site. Treatment was not given for the event. The patient recovered from the event in Jan2021.
Sex: M
Vaccine: COVID19
Symptoms: Exposure via breast milk, Pain
Clinical narrative: feeling body aches; My son who is two years old and still breastfeeding; This is a spontaneous report from a contactable Other-HCP. This Other-HCP reported for two (for herself and baby). This case is for baby second dose. A 2-years-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via transmammary on 18Jan2021 12:15 PM at single dose for COVID-19 immunisation. The patient and his mother's medical history was not reported. The patient's concomitant medications were not reported. The reporter's son (patient) who is two years old and still breastfeeding, also woke up the next morning after the second vaccine feeling body aches on 19Jan2021. Events outcome was unknown.  Information on the batch number/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021066038 maternal cases;US-PFIZER INC-2021068772 baby case (1st dose)
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Pain, Vaccination site pain
Clinical narrative: sever body aches; severe under arm pain; Chills; severe injection site pain; This is a spontaneous report from a contactable nurse (patient).  A 44-year-old female patient received the second dose BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, lot number: EJ1686) in the hospital, via an unspecified route of administration on 19Jan2021 at 08:30 at a single dose on the right arm for COVID-19 immunization. The patient had no medical history nor any concomitant medications. The patient did not have any allergies.  The patient did not have COVID-19 prior to vaccination. The patient did not receive any other vaccine within 4 weeks prior to the COVID-19 vaccine and did not receive other medications within two weeks prior to the COVID vaccine. The patient received the first dose (lot number unknown) of BNT162B2 on 28Dec2020 (age at vaccination: 43 years) on the right arm for COVID-19 immunization. The patient experienced sever body aches, severe under arm pain, chills and severe injection site pain on 20Jan2021 at 02:00 AM. The patient did not receive any treatment for the events. The outcome of the events was recovered. The patient has not been tested for COVID-19 post vaccination.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: body malaise; diarrhea; runny nose; sore throat; fever; dizziness; This is a spontaneous report from a non-contactable nurse. An adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686 and expiry date: unknown), intramuscular on the left arm, on 20Jan2021 07:30 at a single dose for COVID-19 immunization. The first dose was received on 29Dec2020 07:30 (lot number: EL1284), intramuscular on the left arm. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. On 29Jan2021 11:00, the patient experienced body malaise, diarrhea, runny nose, sore throat, fever, dizziness for 3 days. Patient was recovering from the events and did not received treatment. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: body malaise; diarrhea; runny nose; sore throat; fever; dizziness; This is a spontaneous report from a non-contactable nurse. An adult female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EJ1686 and expiry date: unknown), intramuscular on the left arm, on 20Jan2021 07:30 at a single dose for COVID-19 immunization. The first dose was received on 29Dec2020 07:30 (lot number: EL1284), intramuscular on the left arm. The patient's medical history and concomitant medications were not reported. Patient was not pregnant at the time of vaccination. On 29Jan2021 11:00, the patient experienced body malaise, diarrhea, runny nose, sore throat, fever, dizziness for 3 days. Patient was recovering from the events and did not received treatment. Patient was not diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Hot flush
Clinical narrative: Hot flashes (sweating); Cold chills; Joint pain; Fatigue; This is a spontaneous report from a contactable consumer (patient). A 39-year-old male 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, at a single dose, for COVID-19 immunization. The patient's medical history was not reported. There were no concomitant medications. The patient was not diagnosed with COVID-19 prior vaccination. The patient had no known allergies. On 16Jan2021 after receiving the vaccine, the patient experienced hot flashes (sweating), cold chills, joint pain, and fatigue. The symptoms lasted roughly 7 days. No treatment was received for the adverse events. The patient has not been tested for COVID-19 post vaccination. The patient recovered from the events on 23Jan2021.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: nausea; This is a spontaneous report from a non-contactable consumer An adult female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) on an unspecified date at single dose via an unspecified route of administration  for COVID-19 immunization. Relevant medical history and concomitant medications were not reported.  On an unspecified date the patient experienced nausea. The patient recovered from the event on an unknown date.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Sleep disorder, Vaccination site pain
Clinical narrative: Terrible headache/lingering headache; Body ache; Fatigue/tiredness; Slept on and off all day; sore arm at injection site with warmth, swelling and tenderness; sore arm at injection site with warmth, swelling and tenderness; sore arm at injection site with warmth, swelling and tenderness; This is a spontaneous report from a contactable nurse reported for herself. This 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3248, vaccine location=Right arm), via an unspecified route of administration on 19Jan2021 10:15 at single dose for COVID-19 immunisation.  Medical history included Hypothyroid. No known allergies. Patient was not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID) and multivitamin 4 x week. The patient previously received first dose of BNT162B2 (lot number=EL0140, vaccine location=Right arm) on 29Dec2020 at 12:15 PM at single dose for COVID-19 immunisation. On 19Jan2021 06:00 PM (8 hours after injection until 36 hours), patient experienced terrible headache, body ache, fatigue, tiredness, slept on and off all day, sore arm at injection site with warmth, swelling and tenderness. 36-72 hours: back to baseline except lingering headache. No treatment received for events. Patient did not have COVID prior vaccination, and did not test COVID post vaccination. The outcome of events was recovered.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: Terrible headache/lingering headache; Body ache; Fatigue/tiredness; Slept on and off all day; sore arm at injection site with warmth, swelling and tenderness; sore arm at injection site with warmth, swelling and tenderness; sore arm at injection site with warmth, swelling and tenderness; This is a spontaneous report from a contactable nurse reported for herself. This 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number=EL3248, vaccine location=Right arm), via an unspecified route of administration on 19Jan2021 10:15 at single dose for COVID-19 immunisation.  Medical history included Hypothyroid. No known allergies. Patient was not pregnant. Concomitant medications included levothyroxine sodium (SYNTHROID) and multivitamin 4 x week. The patient previously received first dose of BNT162B2 (lot number=EL0140, vaccine location=Right arm) on 29Dec2020 at 12:15 PM at single dose for COVID-19 immunisation. On 19Jan2021 06:00 PM (8 hours after injection until 36 hours), patient experienced terrible headache, body ache, fatigue, tiredness, slept on and off all day, sore arm at injection site with warmth, swelling and tenderness. 36-72 hours: back to baseline except lingering headache. No treatment received for events. Patient did not have COVID prior vaccination, and did not test COVID post vaccination. The outcome of events was recovered.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Injected limb mobility decreased, Swelling, Vaccination site pain
Clinical narrative: swollen, painful left axilla area; swollen, painful left axilla area, gotten progressively worse; difficult to raise arm due pain; difficult to raise arm due pain, very tender to touch, felt like burning; This is a spontaneous report from a contactable Other HCP(patient). A 48-year-old female patient received first dose BNT162B2 (Pfizer BioNTech Covid 19 vaccine, lot number EL3248), via an unspecified route of administration at Arm Left on 16Jan2021 07:00 at the 48 years old at single dose for COVID-19 immunization.  The medical history included HTN(Hypertension), HLD(Hyperlipidemia), Migraines, Depression, Herniated Discs, Arthritis. There were concomitant medications but unspecified. The patient previously took Codeine and experienced allergy. On 22Jan2021 6 days after vaccine, the patient experienced swollen, painful left axilla area, gotten progressively worse, difficult to raise arm due to pain, very tender to touch, felt like burning had continued for 3 days. The patient taken Ibuprofen, Tylenol, and Iced area as treatment for all the events. There was no other vaccine in four weeks. There was no covid prior vaccination. There was no covid tested post vaccination. The outcome of the event was not recovered.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Decreased appetite, Disturbance in attention
Clinical narrative: body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); hot and cold flashes; hot and cold flashes; light runny nose (light, yellowish/green); extreme fatigue; inability to concentrate; loss of appetite; soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration at the left arm on 21Jan2021 at 14:00 (02:00 PM) at single dose for COVID-19 immunization, administered at other facility (as reported). The patient was not pregnant. The patient had no medical history (reported as none). The patient had no COVID prior to vaccination. The patient has no known drug allergies. Concomitant medication included tocopherol (VITAMIN E), cetirizine hydrochloride (ZYRTEC), docosahexaenoic acid, eicosapentaenoic acid (OMEGA-3), and prenatal vitamins. The patient had no other vaccine in four weeks. On 23Jan2021 at 08:00 AM, the patient experienced body aches and weakness, especially in areas that she had previous issues with (low back, ankle, and knee), hot and cold flashes, light runny nose (light, yellowish/green), extreme fatigue, inability to concentrate, loss of appetite, and soreness at injection site. The patient has not been tested for COVID post vaccination. The patient did not receive treatment for the events. The outcome of the events was recovering.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Hot flush, Pain, Rhinorrhoea
Clinical narrative: body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); hot and cold flashes; hot and cold flashes; light runny nose (light, yellowish/green); extreme fatigue; inability to concentrate; loss of appetite; soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration at the left arm on 21Jan2021 at 14:00 (02:00 PM) at single dose for COVID-19 immunization, administered at other facility (as reported). The patient was not pregnant. The patient had no medical history (reported as none). The patient had no COVID prior to vaccination. The patient has no known drug allergies. Concomitant medication included tocopherol (VITAMIN E), cetirizine hydrochloride (ZYRTEC), docosahexaenoic acid, eicosapentaenoic acid (OMEGA-3), and prenatal vitamins. The patient had no other vaccine in four weeks. On 23Jan2021 at 08:00 AM, the patient experienced body aches and weakness, especially in areas that she had previous issues with (low back, ankle, and knee), hot and cold flashes, light runny nose (light, yellowish/green), extreme fatigue, inability to concentrate, loss of appetite, and soreness at injection site. The patient has not been tested for COVID post vaccination. The patient did not receive treatment for the events. The outcome of the events was recovering.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); body aches and weakness, especially in areas that I've had previous issues with (low back, ankle, and knee); hot and cold flashes; hot and cold flashes; light runny nose (light, yellowish/green); extreme fatigue; inability to concentrate; loss of appetite; soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A 34-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL1284), via an unspecified route of administration at the left arm on 21Jan2021 at 14:00 (02:00 PM) at single dose for COVID-19 immunization, administered at other facility (as reported). The patient was not pregnant. The patient had no medical history (reported as none). The patient had no COVID prior to vaccination. The patient has no known drug allergies. Concomitant medication included tocopherol (VITAMIN E), cetirizine hydrochloride (ZYRTEC), docosahexaenoic acid, eicosapentaenoic acid (OMEGA-3), and prenatal vitamins. The patient had no other vaccine in four weeks. On 23Jan2021 at 08:00 AM, the patient experienced body aches and weakness, especially in areas that she had previous issues with (low back, ankle, and knee), hot and cold flashes, light runny nose (light, yellowish/green), extreme fatigue, inability to concentrate, loss of appetite, and soreness at injection site. The patient has not been tested for COVID post vaccination. The patient did not receive treatment for the events. The outcome of the events was recovering.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: severe allergic reaction; This is a spontaneous report from a contactable physician. A 50-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) intramuscular in the left arm on 21Jan2021at a single dose as Covid vaccine. Medical history included BPH, Meniere's disease, and known allergies to sesame oil. The patient had unspecified concomitant medications (other medications in two weeks). He had no other vaccine in four weeks. The patient experienced severe allergic reaction on an unspecified date in which resulted to emergency room/department or urgent care. Unspecified medications was provided as treatment for the event. He had no Covid prior to vaccination. He has not had Covid tested post vaccination. The outcome of the event was recovered on an unspecified date.  No follow-up attempts are possible. Information about lot/batch number cannot obtained. No further information is expected.; Sender's Comments: Based on available information, a possible contributory role of the subject product, BNT162B2 vaccine, cannot be excluded for the reported event of severe allergic reaction. There is limited information provided in this report.    This case will be reassessed once additional information is available.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Diarrhoea, Feeling abnormal, Haemorrhoids
Clinical narrative: had a feeling like taste liberty; Diarrhea; hemorrhoids; This is a spontaneous report from a contactable consumer (patient). A 77-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/lot number: unknown) via an unspecified route of administration on 22Jan2021 at a single dose for COVID-19 immunization. Medical history included diabetic. Concomitant medications were not reported. The patient stated he took the vaccine shot, Covid 19 and he suddenly got diarrhea, hemorrhoids that was on 22Jan2021 on the Friday. Then he experienced some problem with it, the next day the 23Jan2021 it was Saturday. Again he woke up this morning (on 25Jan2021) which was Monday and had a feeling like taste liberty. Asked if that was probably the side effect or a reaction to be treated. Patient stated blood work but he did not have the records right now. Patient stated he took bismuth subsalicylate (PEPTO BISMOL) and a zinc sulfate (PEPTIN, reported as Kill Peptin). He took bismuth subsalicylate Pepto Bismol. It was for the fluid of the stomach and diarrhea. It was called Pepto Bismol. He did not how to spell it. The events were considered as non-serious. The outcome of events was unknown.  Information on the lot/batch number has been requested.