chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood pressure measurement, Body temperature, Body temperature decreased, Hiccups
Clinical narrative: Severe Inflamation. 7 day onset.Hand/Feet swelling; Severe Inflamation. 7 day onset.Hand/Feet swelling; Nerve pain in neck; Stomach cramping; Hiccups; lower than normal blood pressure (99/65 one night same as low temp); lower than normal temperature (95.3F one night); 1-4 Bubbles under skin in back of mouth after eating; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:00 (at the age of 54-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included horrible seasonal allergies, mild asthma, mild Reynod's. The patient had known allergies to NSAIDs (Thought Corn was the cause of the bubbles in mouth, but since the 1st vaccination everything I ate caused it), Dodecyl Gallate, Gentamicin, Neomycin, Nickel, Polymyxin B, Thimerosal, Indium, Manganese, Stannous Chloride, Bee Venom, Hops, Rye, Chocolate, (Thought Corn was the cause of the bubbles in mouth, but since the 1st vaccination everything she ate caused it). Concomitant medication(s)/other medications the patient received within 2 weeks of vaccination included fluticasone, azelastine, famotidine and montelukast. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021 at the patient had severe inflamation. 7-day onset. Hand/Feet swelling, Nerve pain in neck, Stomach cramping (no nausea or diarrhea), Hiccups, lower than normal blood pressure (99/65 one night same as low temp), lower than normal temperature (95.3F one night), Diminished by day 17 after 1st injection. 1-4 Bubbles under skin in back of mouth after eating. As a result of event patient required visit to Doctor or other healthcare professional office/clinic visit. No treatment for the events. The outcome of the events was recovered on an unspecified date in 2021.  No follow up attempts are needed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotension, Neck pain, Peripheral swelling, Skin disorder
Clinical narrative: Severe Inflamation. 7 day onset.Hand/Feet swelling; Severe Inflamation. 7 day onset.Hand/Feet swelling; Nerve pain in neck; Stomach cramping; Hiccups; lower than normal blood pressure (99/65 one night same as low temp); lower than normal temperature (95.3F one night); 1-4 Bubbles under skin in back of mouth after eating; This is a spontaneous report from a contactable consumer or other non-HCP (Patient). A 54-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6199), dose 1 via an unspecified route of administration, administered in Arm Left on 23Mar2021 13:00 (at the age of 54-years-old) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included horrible seasonal allergies, mild asthma, mild Reynod's. The patient had known allergies to NSAIDs (Thought Corn was the cause of the bubbles in mouth, but since the 1st vaccination everything I ate caused it), Dodecyl Gallate, Gentamicin, Neomycin, Nickel, Polymyxin B, Thimerosal, Indium, Manganese, Stannous Chloride, Bee Venom, Hops, Rye, Chocolate, (Thought Corn was the cause of the bubbles in mouth, but since the 1st vaccination everything she ate caused it). Concomitant medication(s)/other medications the patient received within 2 weeks of vaccination included fluticasone, azelastine, famotidine and montelukast. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 30Mar2021 at the patient had severe inflamation. 7-day onset. Hand/Feet swelling, Nerve pain in neck, Stomach cramping (no nausea or diarrhea), Hiccups, lower than normal blood pressure (99/65 one night same as low temp), lower than normal temperature (95.3F one night), Diminished by day 17 after 1st injection. 1-4 Bubbles under skin in back of mouth after eating. As a result of event patient required visit to Doctor or other healthcare professional office/clinic visit. No treatment for the events. The outcome of the events was recovered on an unspecified date in 2021.  No follow up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Nausea, Pain
Clinical narrative: Through out the night, she was nauseous; Through out the night, she had chills; She has pain in her ride side and hip; She has pain in her ride side and hip; She was shaking all over really bad; Headache; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734) via intramuscular route of administration, administered in Arm Right on 07Apr2021 09:45 (at the age of 80 years old) as dose 2, single for COVID-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date (her and her husband had covid in Nov 2020). There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration, administered in Arm Right on 17Mar2021 at 2:30PM (at the age of 80 years old) as single for COVID-19 immunisation and experienced had a back ache and Her neck and shoulder ached. The patient experienced she has pain in her ride side and hip on 07Apr2021, through out the night, she had chills, through out the night, she was nauseous on 08Apr2021, headache, she was shaking all over really bad on Apr2021. Reported as, She received her second dose of the covid vaccine on 07Apr 2021. Her second dose caused her to have chills in the night. Through out the night, she had chills and was nauseous. She also had pain in her ride side and hip. She was wondering. Now all of her symptoms are gone. Her headache was gone as of this morning. She still has pain in her right side and hip. She was wondering, if because she still has symptoms, is still contagious to others. She was shaking all over really bad. Her chills have completely resolved now. The chills stopped by the time she got up. Outcome of the event through out the night, she had chills, through out the night, she was nauseous recovered on 08Apr2021 and other event recovered on Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Through out the night, she was nauseous; Through out the night, she had chills; She has pain in her ride side and hip; She has pain in her ride side and hip; She was shaking all over really bad; Headache; This is a spontaneous report from a contactable consumer (patient). A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734) via intramuscular route of administration, administered in Arm Right on 07Apr2021 09:45 (at the age of 80 years old) as dose 2, single for COVID-19 immunisation. Medical history included covid-19 from Nov2020 to an unknown date (her and her husband had covid in Nov 2020). There were no concomitant medications. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via unspecified route of administration, administered in Arm Right on 17Mar2021 at 2:30PM (at the age of 80 years old) as single for COVID-19 immunisation and experienced had a back ache and Her neck and shoulder ached. The patient experienced she has pain in her ride side and hip on 07Apr2021, through out the night, she had chills, through out the night, she was nauseous on 08Apr2021, headache, she was shaking all over really bad on Apr2021. Reported as, She received her second dose of the covid vaccine on 07Apr 2021. Her second dose caused her to have chills in the night. Through out the night, she had chills and was nauseous. She also had pain in her ride side and hip. She was wondering. Now all of her symptoms are gone. Her headache was gone as of this morning. She still has pain in her right side and hip. She was wondering, if because she still has symptoms, is still contagious to others. She was shaking all over really bad. Her chills have completely resolved now. The chills stopped by the time she got up. Outcome of the event through out the night, she had chills, through out the night, she was nauseous recovered on 08Apr2021 and other event recovered on Apr2021.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 41-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration, on 18Mar2021 (Batch/Lot number was unknown; Expiry date was unknown) as dose 1, single for covid-19 immunisation (at the age of 41-year-old). The patient medical history included autoimmune disorder from an unknown date and unknown if ongoing. The concomitant medication included pyridostigmine bromide (MESTINON) taken for an unspecified indication, start and stop date were not reported. On 18Mar2021, within couple of minutes of vaccination, patient experienced a slight reaction to it. It was not a big reaction, just had some itching and she was tried to figure it out. The patient does not wish for second shot because of the itching. She was enquired about the event as considered as a side effect or is that considered to be a reaction. The patient took Benadryl for the treatment of events. The outcome of the events was unknown.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Chills, Nasopharyngitis, Pain, Peripheral vascular disorder
Clinical narrative: Arm Swells Up; poor hand circulation; Felt like she had a slight cold; Lost sense of taste; Body Aches throughout body, especially in legs; Chills; This is a spontaneous report from a contactable consumer (patient) or other non hcp.  A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: ER8730 via an unspecified route of administration, administered in Deltoid Left on 26Mar2021 (at the age of 63-years-old) as dose 1, single for COVID-19 immunisation. Medical history included high blood pressure, ongoing. Concomitant medication included influenza vaccine (FLU) taken for an unspecified indication, start and stop date were not reported. No investigation assessment was performed. No prior vaccinations (within 4 weeks). On an unspecified date in Mar2021, the patient felt like she had a slight cold, lost sense of taste, body aches throughout body, especially in legs, chills and poor hand circulation. On an unspecified date, the patient's arm swells up. The patient was due for her second dose on 16Apr2021 and was asking if she would be able to take the second dose on that day. The outcome of the events felt like she had a slight cold, lost sense of taste, body aches throughout body, especially in legs, chills and poor hand circulation was recovering. The outcome of the event arm swells up was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure measurement, Cough, Epistaxis, Feeling abnormal, Nasopharyngitis
Clinical narrative: FEELS BAD FOR COUPLE OF DAYS; HE WAS COLD; COUGH; THROAT IS VERY UNCOMFORTABLE WHEN HE TALKS; BLOOD FROM HIS NOSE; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: EC-2021-089076), for bnt162b2. A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Apr2021 as dose number unknown, single for COVID-19 immunization. Medical history included type 2 diabetes with diabetic nephropathy, diabetic nephropathy, hyperglycaemia and Unspecified cirrhosis of the liver. Concomitant medications included lenvatinib mesilate (LENVIMA) taken for Liver cell Carcinoma; Ibuprofen (IBUPROFEN) taken for an unspecified indication and canagliflozin (INVOKANA [CANAGLIFLOZIN]), sitagliptin (JANUVIA [SITAGLIPTIN]), tenofovir alafenamide fumarate (VEMLIDY), carvedilol (CARVEDILOL), glipizide (GLIPIZIDE), simethicone (SIMETHICONE) and pravastatin sodium (PRAVASTATIN SODIUM), all were taken for an unspecified indication from an unknown start and stop date. Patient wife reported that, patient received covid vaccine last Friday on 09Apr2021 and on an unspecified date in Apr2021 feels bad for couple of days. He was cold but getting better, sometimes he coughs and his Throat was very uncomfortable when he talks and also he talks he has blood from his nose. She stated blood pressure little higher since starting on Lenvima. Physician was aware. The patient underwent lab tests and procedures which included blood pressure measurement results with little higher. Outcome of he was cold was recovering and outcome of other events was unknown.  No follow-up attempts needed. No further follow-up information expected.
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort
Clinical narrative: FEELS BAD FOR COUPLE OF DAYS; HE WAS COLD; COUGH; THROAT IS VERY UNCOMFORTABLE WHEN HE TALKS; BLOOD FROM HIS NOSE; This is a spontaneous report from a contactable consumer, based on information received by Pfizer (manufacturer control number: EC-2021-089076), for bnt162b2. A male patient of an unspecified age received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 09Apr2021 as dose number unknown, single for COVID-19 immunization. Medical history included type 2 diabetes with diabetic nephropathy, diabetic nephropathy, hyperglycaemia and Unspecified cirrhosis of the liver. Concomitant medications included lenvatinib mesilate (LENVIMA) taken for Liver cell Carcinoma; Ibuprofen (IBUPROFEN) taken for an unspecified indication and canagliflozin (INVOKANA [CANAGLIFLOZIN]), sitagliptin (JANUVIA [SITAGLIPTIN]), tenofovir alafenamide fumarate (VEMLIDY), carvedilol (CARVEDILOL), glipizide (GLIPIZIDE), simethicone (SIMETHICONE) and pravastatin sodium (PRAVASTATIN SODIUM), all were taken for an unspecified indication from an unknown start and stop date. Patient wife reported that, patient received covid vaccine last Friday on 09Apr2021 and on an unspecified date in Apr2021 feels bad for couple of days. He was cold but getting better, sometimes he coughs and his Throat was very uncomfortable when he talks and also he talks he has blood from his nose. She stated blood pressure little higher since starting on Lenvima. Physician was aware. The patient underwent lab tests and procedures which included blood pressure measurement results with little higher. Outcome of he was cold was recovering and outcome of other events was unknown.  No follow-up attempts needed. No further follow-up information expected.
Sex: U
Vaccine: COVID19
Symptoms: Facial pain, Swelling face
Clinical narrative: developed diffuse swelling of the face, painful to the touch; developed diffuse swelling of the face, painful to the touch; This is a spontaneous report from a non-contactable other healthcare professional. A patient of unknown age and gender received second dose of bnt162b2 (BNT162B2, solution for injection, Batch/lot number: not reported, expiry date: not reported) via an unknown route of administration on an unknown date as dose 2, single for covid-19 immunization. The patient medical history was not reported. Concomitant medications included hyaluronic acid, lidocaine (JUVEDERM ULTRA 3) dose 3cc in the nasolabial fold (a month after JUVERDERM ULTRA 3), marionettes and tear trough taken for an unspecified indication. The patient previously received first dose of bnt162b2 (BNT162B2, solution for injection, Batch/Lot number: not reported, expiry date: not reported) via an unspecified route of administration on an unknown date as dose 1, single for covid-19 immunization. On an unknown date, the patient developed diffuse swelling of the face, painful to the touch (next day of vaccination). Telfast and Aerius (Desloratadine) Tabs were given as therapeutic measure for the events. HCP advised, there was a significant improvement a day later. Clinical outcome of the events was reported as recovering.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Pain, Rash pruritic, Swelling
Clinical narrative: itchy bumps in the Botox injection sites on her forehead, pain, swelling and redness for 12 hours; itchy bumps in the Botox injection sites on her forehead, pain, swelling and redness for 12 hours; itchy bumps in the Botox injection sites on her forehead, pain, swelling and redness for 12 hours; itchy bumps in the Botox injection sites on her forehead, pain, swelling and redness for 12 hours; This is a spontaneous report received from a non-contactable consumer. A patient of an unspecified age and gender received Botulinum toxin type A (BOTOX) to the forehead on 17Jan2021 and bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch no/Lot number: not reported) via an unspecified route of administration on 19Jan2021 as dose number unknown, single for COVID-19 immunization. On an unspecified date in Jan2021 (reported as 30 hours later) patient returned to the clinic with itchy bumps in the Botox injection sites on her forehead, pain, swelling and redness for 12 hours. Treatment was not received for the events. Outcome of the events was recovered without treatment on an unspecified date in 2021.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Swelling, Vaccination site pain
Clinical narrative: experience swelling; pain at the injection sites; This is a spontaneous report from a non-contactable physician. A patient of unspecified age and gender received BNT162B2, via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included lidocaine hcl  and hyaluronic acid, both for an unspecified indication. The patient was injected approx. 10 months prior with Juvederm VOLUMA with Lidocaine and Juvederm  VOLBELLA with Lidocaine and 11 months prior with Juvederm VOLUMA with Lidocaine and Juvederm  VOLITE. On an unspecified date, after the second dose, patient experienced swelling and pain at the injection sites. Patient was treated with Telfast and betacorten steroidal ointment. Symptoms resolved. The outcome of the events was recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: 2 days later the patient complained of major swelling of all cheeks and lips area; 2 days later the patient complained of major swelling of all cheeks and lips area; This is a spontaneous report from a non-contactable other hcp. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Concomitant medications included hyaluronic acid (VOLUMA T1 1ml). 2 days later of second dose the patient complained of major swelling of all cheeks and lips area. Patient started 40 mg prednisone for 5 days and fexofenadine for 7 days. At the time of reporting, patient's symptoms improved but still ongoing. The clinical outcome of the events was recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: major swelling of all cheeks and lips area; major swelling of all cheeks and lips area; This is a spontaneous report received from AbbVie from non contactable other Healthcare professional. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that the patient had received 3 ml of VOLITE in lips area, cheeks CK45. After 4 months on an unknown date, the patient had received COVID-19 2nd vaccination. After 2 days following vaccination on an unspecified date, the patient had complained of major swelling of all cheeks and lips area. Therapeutic measures were taken because of major swelling of all cheeks and lips area and included 40 mg prednisone for 5 days and fexofenadine for 7 days. The patient symptoms had improved and were ongoing. The outcome of all events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Lip swelling, Swelling face
Clinical narrative: 2 days later the patient complained of major swelling of all cheeks and lips area; 2 days later the patient complained of major swelling of all cheeks and lips area; This is spontaneous report received from a HCP reporter. A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration on an unspecified date as SINGLE DOSE for covid-19 immunisation; hyaluronic acid, route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history and concomitant medications were not reported. It was reported that, 4 months later patient had COVID19 2nd vaccination, 2 days later the patient complained of major swelling of all cheeks and lips area. Patient started 40 mg prednisone for 5 days and fexofenadine for 7 days. Patient symptoms have improved. Update that HCP feels event is not device related. Symptoms on going. The outcome of the events was resolving.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Lip pain, Lip swelling
Clinical narrative: patient received the Pfizer vaccine and noticed lip swelling and tenderness 48 hours later; patient received the Pfizer vaccine and noticed lip swelling and tenderness 48 hours later; This is a spontaneous report from a non-contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication included hyaluronic acid (HYALURONIC ACID) taken for an unspecified indication, start and stop date were not reported. Patient reports lip injection with 1 syringe of JUVEDERM VOLBELLA. The following month patient received the Pfizer vaccine and noticed lip swelling and tenderness 48 hours later. Patient took Benadryl. No diagnostic testing was administered. The events reported were non serious. The symptoms outcome was resolved 3 days later. No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Inappropriate schedule of product administration, Pain
Clinical narrative: Patient had received first dose of Pfizer Covid-19 vaccine one month prior to filler injection and second dose two weeks prior to filler injection; pain; redness; This is a spontaneous report from a non-contactable other hcp. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included hyaluronic acid (JUVEDERM ULTRA) taken for an unspecified indication, start and stop date were not reported. The patient experienced patient had received first dose of Pfizer covid-19 vaccine one month prior to filler injection and second dose two weeks prior to filler injection on an unspecified date, pain on an unspecified date, redness on an unspecified date. The outcome of the events inappropriate schedule of product administration, pain, erythema was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Swelling, Swelling face
Clinical narrative: facial swelling post receiving a Covid vaccine/chin [is] uncomfortable/swelling in these areas; swelling/hard and lumpy; This is a spontaneous report from a non-contactable other- healthcare professional (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Lot Number: UNKNOWN), via an unspecified route of administration as dose number unknown, single for COVID-19 immunization; hyaluronic acid (JUVEDERM), into the pre-jowl area, route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient's medical history was not reported. Concomitant medication included thyroid (ARMOUR THYROID), 180 mg and fortnightly injections of TNF therapy taken for an unspecified indication, start and stop date were not reported. On an unspecified date, the patient presented with swelling in these areas (pre-jowl area)3 weeks post COVID-19 vaccine. The cheeks were said to be not too bad but the chin [was] uncomfortable and persistent. Treatment started with antihistamines. The area then became lumpy so treatment with Prednisolone started. Patient was still hard and lumpy. The clinical outcome for the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Eye swelling
Clinical narrative: This is a spontaneous report received from a non-contactable HCP (Physician) reported for multiple patients. One in that a patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/lot number: was not reported) via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication(s) included hyaluronic acid, lidocaine hydrochloride (JUVEDERM VOLBELLA WITH LIDOCAINE) taken for an unspecified indication, start and stop date were not reported. The patient experienced swelling under the eyes on an unspecified date. Clinical course was reported as Injecting Physician reported that two days after the second Pfizer Covid-19 vaccine, the patient experienced swelling under the eyes. Patient received Unknown Juvederm® VOLBELLA prior to the vaccine. The patient received treatment with Telfast Tabs for 5 days and Beta Corten ointment for the adverse events. The clinical outcome of the event was recovered. Therapeutic measures were taken as a result of swelling under the eyes.  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Eyelid oedema, Oedema
Clinical narrative: edema on chin and lower eyelids; edema on chin and lower eyelids; This is a spontaneous report from a non-contactable consumer. This consumer reported for an other HCP (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was injected with 1ml Voluma in temples, 3 ml Voluma cheeks, 1 ml Volift midface, 1 ml Volbella tear trough and 3 ml Volux in chin. Two months later patient also received 0.5 ml non-Allergan dermal filler in lips and a small correction of 0.1 ml in the left tear trough. Following month, patient received a covid19 vaccine. Next morning, patient woke up in the morning with edema on chin and lower eyelids. The outcome of the events were not recovered (symptoms on going).  No follow-up attempts are possible. Information related to batch/lot number could not be requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: She has pain at the injection site; low grade fever; She's been feeling fatigued; His wife has not been feeling well; This is a spontaneous report received from a contactable consumer (patient husband). A female patient [reporter wife] of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 08Apr2021, as single dose for COVID-19 immunization. Medical history, concomitant medications or past drug history of the patient were not reported. On an unspecified date in Apr2021, after receiving vaccination, patient experienced pain at the injection site, low grade fever, feeling fatigued and not feeling well. Reporter asked what to do about those side effects. Outcome of the events were unknown.  No follow-up attempts are needed. Information on lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Rash erythematous, Urticaria
Clinical narrative: My stomach is full of I want to say hives, it's red, it's burning, it's full of rash; My stomach is full of I want to say hives, it's red, it's burning, it's full of rash; My stomach is full of I want to say hives, it's red, it's burning, it's full of rash; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown), via an unspecified route of administration on 07Apr2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Apr2021, after vaccination, the patient experienced stomach was full of, the patient wants to say hives, it's red, it's burning, it's full of rash. It was reported that the patient was calling with a question and a concern that the patient took 1st dose of the Pfizer shot yesterday and stomach was full of, the patient wants to say hives, it's red, it's burning, it's full of rash. The patient wanted to know is that normal or any recommendations that the patient can use to take away that symptom or is it a normal 'allergy'. Consumer was unwilling to share further information hence product details and other details were unknown. Limited information was available over the call. The outcome of events was unknown.  Information about batch/lot number cannot be obtained. No further information is expected
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Feeding disorder, Feeling hot
Clinical narrative: fatigue; basically unable to eat or even drink; Pain on under her shoulder; she got chills; severe shaking; Nausea, nauseous; feel still hot; This is a spontaneous report from a contactable consumer (patient's parent). A 23-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: Unknown), via an unspecified route of administration on 14Mar2021 (at the age of 23-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included autoimmune conditions, colitis ulcerative, connective tissue disorder/lupus, inflammatory problems; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took antibiotics for 10 years for one disease, naltrexone, mesalamine, loxoprofen for anxiety. The reporter stated that her daughter (patient) was 23 years old and had taken medications for autoimmune conditions, the patient had ulcerative colitis and connective tissue disorder/lupus and had got both those condition because she was on unspecified antibiotics for 10 years for one disease and then she ended up with lot of inflammatory problems. So, she was on Naltrexone, Mesalamine and Loxoprofen for anxiety. The patient took the first shot of bnt162b2 on 14Mar2021 and had severe effects after 20 minutes, she got chills and severe shaking and nausea and she felt still hot that they went to the emergency room, her shaking was subsided, the reporter stated might be after 3 to 5 minutes, so basically the patient got Zofran as treatment for her nausea and came home and in the next two days she was nauseous and fatigue and basically unable to eat or even drink and had pain on under her shoulder which was not a big deal. The reporter questioned if the patient should take the second shot because she had received like a pretty strong response to the first and will the 2nd shot create any Inflammatory disorder that she didn't have at that point or do you have any information or worse. Further she stated, basically a quick question so what causes that chill and shaking, was that a shock kind of response or was that vaccine reaction. Therapeutic measures were taken as a result of nausea. The outcome of all the events was unknown while shaking was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tremor
Clinical narrative: fatigue; basically unable to eat or even drink; Pain on under her shoulder; she got chills; severe shaking; Nausea, nauseous; feel still hot; This is a spontaneous report from a contactable consumer (patient's parent). A 23-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported, Expiry date: Unknown), via an unspecified route of administration on 14Mar2021 (at the age of 23-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included autoimmune conditions, colitis ulcerative, connective tissue disorder/lupus, inflammatory problems; all from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient previously took antibiotics for 10 years for one disease, naltrexone, mesalamine, loxoprofen for anxiety. The reporter stated that her daughter (patient) was 23 years old and had taken medications for autoimmune conditions, the patient had ulcerative colitis and connective tissue disorder/lupus and had got both those condition because she was on unspecified antibiotics for 10 years for one disease and then she ended up with lot of inflammatory problems. So, she was on Naltrexone, Mesalamine and Loxoprofen for anxiety. The patient took the first shot of bnt162b2 on 14Mar2021 and had severe effects after 20 minutes, she got chills and severe shaking and nausea and she felt still hot that they went to the emergency room, her shaking was subsided, the reporter stated might be after 3 to 5 minutes, so basically the patient got Zofran as treatment for her nausea and came home and in the next two days she was nauseous and fatigue and basically unable to eat or even drink and had pain on under her shoulder which was not a big deal. The reporter questioned if the patient should take the second shot because she had received like a pretty strong response to the first and will the 2nd shot create any Inflammatory disorder that she didn't have at that point or do you have any information or worse. Further she stated, basically a quick question so what causes that chill and shaking, was that a shock kind of response or was that vaccine reaction. Therapeutic measures were taken as a result of nausea. The outcome of all the events was unknown while shaking was recovering.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthma, Pain in extremity
Clinical narrative: missed the second dose of the Covid 19 vaccine; Arm hurt; asthma attack; This is a spontaneous report from a contactable pharmacist reported for a male consumer. A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation. Medical history included severe asthma from an unknown date and unknown if ongoing (Verbatim: severe asthma). Concomitant medications were not reported. On an unspecified date the patient experienced missed the second dose of the covid 19 vaccine, arm hurt, asthma attack. Report 1 of 3. Reporter is a pharmacist calling regarding the Pfizer Covid 19 Vaccine. Reporter stated that she has several patients who have taken the first dose of the vaccine. For different medical reasons, these patients had between 10 and 60 days between the first and requesting the second shot. Reporter has several patients that have missed the second dose of the Covid 19 vaccine. Reporter asking at what point would they restart the series. Do they have to restart the series. Within what period of time. Do they have to do this with Covid. Is there any documentation or literature on this subject. Has one patient who has severe asthma got the first shot and had an attack. This patient is over the age of 65. Stated that he started having an attack and was given a high dose of steroids and was off of them in 10 days. Reporter that none of these patients reported any side effects from the vaccine except their arm hurt. Reporter confirmed she does not have any lot information on her to provide. Outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021398935 same reporter/drug/AE, different patient
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Drug hypersensitivity, Oedema, Swelling, Urticaria
Clinical narrative: strong allergic reaction; developed the strongest oedema in the chin; patient had also presented with swelling in other places where they had over the years; developed an urticarial rash on their shins; RN 2345521 and LRN 2346395.  This is a spontaneous report from health care professional.  A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Lot number were not provided, Expiration date were not provided), via an unspecified route of administration as unknown dose number, single for covid-19 immunisation. The patient's medical history included swelling in other places. Concomitant medication was not reported. On an unspecified date, the patient experienced strong allergic reaction to [the Pfizer COVID-19 vaccine] in places where they had been injected with Juvederm six days after the vaccination. The patient developed the strongest oedema in the chin where they had the most recent Juvederm injection with Juvederm VOLBELLZ with Lidocaine. The patient had also presented with swelling in other places where they had over the years been treated with [unspecified] fillers in the nasolabial line and between the eyes. The patient has now also developed an urticarial rash on their shins. The swelling had got worse throughout the day. The patient received treatment included dose of allergy medications. This record captures events relating to Juvederm VOLBELLA with Lidocaine. Complaint Dermal. At the time of reporting, the outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Swelling of vycross fillers; This is a spontaneous report received from a non-contactable other HCP.   A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Six days after receiving the vaccination, patient developed swelling of vycross fillers 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.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: swelling; This is a spontaneous report based on information received by Pfizer from regulatory authority. A contactable Physician reported for a patient of unspecified age and gender received Unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Physician reported that patient was injected with Juvederm Voluma Xc. Two years later, the patient received the Pfizer COVID-19 vaccine and experienced swelling. The patient was treated with Lisinopril twice. Outcome of the event was Recovered.  No follow up attempts are possible; information about lot number/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaginal haemorrhage
Clinical narrative: vaginal bleeding; This is a spontaneous report from a contactable female patient who reported for herself and her sister. This report is for her sister:  A 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: Unknown), via an unspecified route of administration on unspecified date as a single dose for COVID-19 immunization. The patient medical history and concomitant medication were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection Lot Number: Unknown) via unspecified route of administration on unspecified date as a single dose for COVID-19 immunization. On 10Apr 2021 the patient experienced vaginal bleeding. Caller states her sister is experiencing vaginal bleeding, states that she started bleeding on Saturday, 10Apr2021 and has not stopped, states she knows there have been reports of this being a possible side effect of the vaccine. Caller wants to know if this is a side effect of the vaccine. How long this may last. The outcome of the reported event was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021401446 same reporter/drug/AE, different patients
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: had some itchiness on her neck; This is a spontaneous report from a contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (COMIRNATY, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 12Mar2021 as Dose 1, Single and via an unspecified route of administration on 02Apr2021 as Dose 2, Single for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient stated that she had experienced some itchiness on her neck after the 1st dose (12Mar2021) and continuously happening until now. She had her second dose (last 2nd of April). The outcome of the event itchiness on her neck was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Migraine, Nasal dryness, Oropharyngeal pain, Pyrexia
Clinical narrative: Severe migraine; dry nose; sore throat; fever (spike at 102.8F); This is a spontaneous report from a contactable consumer (patient reported for himself). A male patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: Unknown), via an unspecified route of administration on 08Apr2021 approximately at 14:40 as a dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medication were not reported. On 09Apr2021 approximately at 11:00 the patient experienced severe migraine, dry nose, sore throat and fever (spike at 102.8F). Outcome of all the reported events was recovered on 10Apr2021 approximately at 16:30.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 82.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Pain
Clinical narrative: weak and tired, cannot get out of bed/hard to raise her head she is so weak; weak and tired, cannot get out of bed; slight shortness of breath; body aches but they have been worse; This is a spontaneous report from a contactable nurse. This 82-year-old female nurse (patient) reported.  An 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: ER8734), dose 2 via an unspecified route of administration, administered in Right arm on 31Mar2021 (at the age of 82-years-old) as dose 2, single for covid-19 immunisation. Medical history included rods in back from an unknown date and unknown if ongoing. The patient concomitant medications were not reported. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number: EN6206), dose 1 via an unspecified route of administration, on 10Mar2021 (at the age of 82-years-old) as dose 1, single for covid-19 immunisation and felt her arm was going to explode, Tired and shortness of breath after first dose of vaccine, she had a rotator cuff in her right arm that needed to be repaired which was an issue prior to the vaccine, and that was probably why it hurt so badly and had gotten better. Exact details were not provided. On an unknown date in Apr2021, the patient experienced weak and tired, cannot get out of bed, slight shortness of breath and body aches but they have been worse. The reporter stated that she had her shots last month, clarifies the Pfizer Covid vaccines, states 31Mar2021 was her second dose, first dose was 10Mar2021, states she felt fine until this past weekend. On an unspecified date on Apr2021, the patient stated that she has slight shortness of breath, is very tired and weak, cannot stay out of bed, has a hard time getting up. Her appetite is great, no nausea or vomiting or anything. States her symptoms started this week, no exact dates provided. The reporter stated she has rods in her back so maybe that is why she cannot get out of bed, she needs help, states it is hard to raise her head she is so weak, has to use her hands, states she typically deals with body aches but they have been worse this week. The reporter states that all of her symptoms have just been persisting since they started this week. The outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.