chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Second shot rash; This is a spontaneous report from a contactable consumer(patient). A 78-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201; Expiration Date: Jun2021), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications was not reported. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EL3302, Expiration Date: May2021), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation and experienced some pain around the shot area. The patient experienced second shot rash on 12Feb2021. The outcome of the event was recovered on Feb2021.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: rash all over chest, neck and back that is not not solid rash but splotchy; itching; This is a spontaneous report from a contactable consumer (patient). A 68-year-female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Mar2021 as single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient got the second dose of the Pfizer covid 19 vaccine on Friday (19Mar2021) and had some itching yesterday (21Mar2021) but she did not pay attention to it. Today (22Mar2021), she noticed after a shower that she had rash all over chest, neck and back that was not solid rash but splotchy. She thought that it could be because of the vaccine since she did not recall getting something else. She was 68 years old. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: itching; severe pain in the arm; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on 12Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history was not reported. The patient concomitant medication was not reported. PQC was not provided.  On an unspecified date the patient experienced severe pain in the arm and itching. Reporter stated that she knows some people have had different side effects. She wanted to know if there have been reports of itching and should she take Benadryl or go to HCP. Reporter wanted to know how long should the itching last/how long should that be before she goes to HCP. The clinical outcome of the events severe pain in the arm was resolved on an unspecified date and itching was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: had a side effect of a rash; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE for covid-19 immunization. Medical history included allergic to Nickel and allergic to Gold. The patient's concomitant medications were not reported. The patient previously took Bactrim and experienced drug allergy. On an unspecified date, after the vaccination she had a side effect of a rash. Caller asking if this was because she is allergic to bactrim, nickel and gold. At the time of this report, the outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Petechiae
Clinical narrative: petechial rash to both lower legs; This is a spontaneous report from a contactable other healthcare professional. A 27-years-old female patient received bnt162b2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Batch/Lot number was unknown), dose 1 via an unspecified route of administration on an unspecified date in Mar2021, 3 weeks before the time of reporting, as DOSE 1, SINGLE (at the age of 27-years-old) for COVID-19 immunisation. The patient's medical history included vitamin B 12 deficiency from an unknown date and unknown if ongoing. There were no concomitant medications. The patient has had no other recent vaccinations or started any new medications that the reporter knows of. The patient experienced petechial rash to both lower legs on 17Mar2021, 5 days before the time of report. The reporter would like to know whether this has been reported before. The patient was due to her second dose of the vaccine the next day of reporting (i.e., 23Mar2021) but reporter would tell her to hold. The reporter said that the rash sounds pretty persistent, patient said they had it since 17Mar2021, and has done no treatment, and no medicine for it. The patient underwent lab tests and procedures which included lab test: results not provided on an unspecified date. The reporter stated that for the rash they were waiting on labs, but there was potential to be serious, unknown at that time. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Heart rate, Heart rate increased, Myalgia
Clinical narrative: Muscle pain; muscle soreness; Shortness of breath; Increased heart rate; This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number was not reported), via an unspecified route of administration, on 23Feb2021, as dose 1, single, for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received his first dose of Pfizer-BioNTech COVID-19 vaccine on 23Feb2021 and was originally scheduled for his second dose 23Mar2021. In 2021, the patient has been experiencing symptoms such as muscle pain, shortness of breath, and increased heart rate. Lots of muscle soreness comes. The patient asked if it was okay to take it. The patient has already rescheduled his second dose for 41 days after the first. The patient wanted to know what he should do about receiving the second dose. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot or batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: breaking out with a rash under her breasts, back, side of the arm, thighs, stomach; This is a spontaneous report from a contactable consumer (patient) via Medical Information Team. A female patient of an unspecified age (Age: 68; Units: Unknown) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on 07Mar2021 (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that two days later on the 09Mar2021, she began breaking out with a rash under her breasts, back, side of the arm, thighs, stomach. She spoke with her doctor virtually yesterday (on an unspecified date) and was prescribed Presdnisone and clotrimazole/betamethsone cream. The doctor said to wait until these side effects subside until she received the second dose which was scheduled for 07Apr2021, and the patient asked should she receive the second dose. The event outcome was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Allergy to arthropod bite, Eye swelling, Lip swelling, Lymphadenopathy, Paraesthesia oral
Clinical narrative: My tongue was swelling; my mouth was tingly; my face was swelling; lips were swelling; my glands under my chin was swollen; I had a rash on my neck; eyes were pretty swollen; I had a spider bite; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on 12Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Mar2021, the patient experienced my tongue was swelling, my mouth was tingly, my face was swelling, lips were swelling, my glands under my chin were swollen, patient had a rash on her neck, eyes were pretty swollen, patient thought she had a spider bite. Therapeutic measures were taken which include Benadryl for every 4 hours. The next day patient cut down Benadryl the next day, but still have to take during certain times a day. This went over the weekend. Yesterday, patient took just one dose. But patient tongue was swollen and fingers were tingly. The patient received treatment for the events. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash, Swelling face, Swollen tongue
Clinical narrative: My tongue was swelling; my mouth was tingly; my face was swelling; lips were swelling; my glands under my chin was swollen; I had a rash on my neck; eyes were pretty swollen; I had a spider bite; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 63-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on 12Mar2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On 18Mar2021, the patient experienced my tongue was swelling, my mouth was tingly, my face was swelling, lips were swelling, my glands under my chin were swollen, patient had a rash on her neck, eyes were pretty swollen, patient thought she had a spider bite. Therapeutic measures were taken which include Benadryl for every 4 hours. The next day patient cut down Benadryl the next day, but still have to take during certain times a day. This went over the weekend. Yesterday, patient took just one dose. But patient tongue was swollen and fingers were tingly. The patient received treatment for the events. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: head started to itch; hives all over her scalp that travelled to her chin, neck, and back down to shoulder blades; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). A 45-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered anatomical location not reported, on 09Mar2021 16:00 (at the age of 45-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. On 09Mar2021 19:00, the patient head started to itch, patient had hives all over her scalp that travelled to her chin, neck, and back down to shoulder blades. The patient stated she took BENADRYL to treat with no relief and then took another BENADRYL 20 minutes later and the symptoms finally began to subside. The patient wanted to know if she should get the second dose. The patient asked if it is okay to delay the second dose of the vaccine and what if she waits a whole year to get the second dose. The outcome of the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Pharyngeal swelling
Clinical narrative: She could not swallow; throat swelled up; This is a spontaneous report from a contactable consumer (patient) via a Pfizer-sponsored program Support. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 27Feb2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 27Feb2021, the patient experienced throat swelled up/swollen throat. She could not swallow. She took her second dose of the vaccine on 22Mar2021 as scheduled. She experienced throat swelling after second dose as well as first dose. She had difficulty swallowing after first dose, but not second dose. The reporter added that the throat swelling was not visually verified by HCP. She was monitored at vaccination site both times by HCP and throat swelling resolved on its own within 30 minutes without need for intervention. The outcome of the event she could not swallow was unknown. The outcome of the event was throat swelling was recovered.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain, Rash, Swelling, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A female patient, of unspecified age, received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine), via an unspecified route of administration, on Mar 14, 2021, single dose, for COVID-19 immunisation. Medical history and concomitant medications not reported. She received the 1st dose on Mar 14, 2021. On Thursday, Mar 18, 2021, there was swelling and a weltering rash on the outside of her neck. She had an extreme sore throat on Mar 2021. She asked how she can treat these. She was still experiencing these side effects. The outcome of events: not recovered. No follow-up attempts possible. Information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Dysgeusia, Headache, Hypersensitivity, Inflammation
Clinical narrative: the shot "felt warm" when injected; metallic taste in her mouth; itchiness in her nose, ears, and throat; rash at the injection site; severe headache; hands and feet swelled; she doesn't feel comfortable; inflammation; I had delayed allergic reaction; I have chronic issue with inflammation and respiratory to begin with; I'm a little bit nervous; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: unknown), dose 1 in the left arm on 04Mar2021 as Dose 1 SINGLE for covid-19 immunization (Age at vaccination was 65-Years-old). The patient medical history included she had sinuses and inflammation. On an unspecified date the patient had Injection site warmth, metallic taste in her mouth, itchiness in her nose, ears, and throat, rash at the injection site, severe headache, hands and feet swelled, discomfort, inflammation, allergic reaction. The reporter reported that she talked to her doctor's office this morning, so she had this first injection of Pfizer one almost 3 weeks ago and she was scheduled to have the second one on Thursday. she had delayed allergic reaction about 5 hours later. It had been what she considered she had allergies on her life and primarily medication (Captured as Unspecified medication) but she was considered moderate. she didn't have breathing issues, but she had the nose and the itchy eyes, ears and throat then she got the mouth reaction like on the warm parts on her arm you know like. So they didn't affect her breathing. Then the next day she had swelling in my left side in my arm, the whole way end to her back, even her hands were swollen for 2 days. The patient reported that for 3 days she had got inflammation. She worked for agency. she was responders. So she had lot more sensitivities from work you know at a site (Intent: History). So she had chronic issue with inflammation and respiratory to begin with. So she called her doctor today to see if maybe she should do some Benadryl or something before, she went. she was nervous about taking the second shot because she had such a moderate reaction to the first shot (Further not confirmed hence captured as unspecified shot). The outcome of the events was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash, Injection site warmth, Malaise, Nervousness, Peripheral swelling
Clinical narrative: the shot "felt warm" when injected; metallic taste in her mouth; itchiness in her nose, ears, and throat; rash at the injection site; severe headache; hands and feet swelled; she doesn't feel comfortable; inflammation; I had delayed allergic reaction; I have chronic issue with inflammation and respiratory to begin with; I'm a little bit nervous; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: unknown), dose 1 in the left arm on 04Mar2021 as Dose 1 SINGLE for covid-19 immunization (Age at vaccination was 65-Years-old). The patient medical history included she had sinuses and inflammation. On an unspecified date the patient had Injection site warmth, metallic taste in her mouth, itchiness in her nose, ears, and throat, rash at the injection site, severe headache, hands and feet swelled, discomfort, inflammation, allergic reaction. The reporter reported that she talked to her doctor's office this morning, so she had this first injection of Pfizer one almost 3 weeks ago and she was scheduled to have the second one on Thursday. she had delayed allergic reaction about 5 hours later. It had been what she considered she had allergies on her life and primarily medication (Captured as Unspecified medication) but she was considered moderate. she didn't have breathing issues, but she had the nose and the itchy eyes, ears and throat then she got the mouth reaction like on the warm parts on her arm you know like. So they didn't affect her breathing. Then the next day she had swelling in my left side in my arm, the whole way end to her back, even her hands were swollen for 2 days. The patient reported that for 3 days she had got inflammation. She worked for agency. she was responders. So she had lot more sensitivities from work you know at a site (Intent: History). So she had chronic issue with inflammation and respiratory to begin with. So she called her doctor today to see if maybe she should do some Benadryl or something before, she went. she was nervous about taking the second shot because she had such a moderate reaction to the first shot (Further not confirmed hence captured as unspecified shot). The outcome of the events was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: the shot "felt warm" when injected; metallic taste in her mouth; itchiness in her nose, ears, and throat; rash at the injection site; severe headache; hands and feet swelled; she doesn't feel comfortable; inflammation; I had delayed allergic reaction; I have chronic issue with inflammation and respiratory to begin with; I'm a little bit nervous; This is a spontaneous report from a contactable consumer. A 64-years-old female patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Strength: unknown, Batch/Lot Number: unknown), dose 1 in the left arm on 04Mar2021 as Dose 1 SINGLE for covid-19 immunization (Age at vaccination was 65-Years-old). The patient medical history included she had sinuses and inflammation. On an unspecified date the patient had Injection site warmth, metallic taste in her mouth, itchiness in her nose, ears, and throat, rash at the injection site, severe headache, hands and feet swelled, discomfort, inflammation, allergic reaction. The reporter reported that she talked to her doctor's office this morning, so she had this first injection of Pfizer one almost 3 weeks ago and she was scheduled to have the second one on Thursday. she had delayed allergic reaction about 5 hours later. It had been what she considered she had allergies on her life and primarily medication (Captured as Unspecified medication) but she was considered moderate. she didn't have breathing issues, but she had the nose and the itchy eyes, ears and throat then she got the mouth reaction like on the warm parts on her arm you know like. So they didn't affect her breathing. Then the next day she had swelling in my left side in my arm, the whole way end to her back, even her hands were swollen for 2 days. The patient reported that for 3 days she had got inflammation. She worked for agency. she was responders. So she had lot more sensitivities from work you know at a site (Intent: History). So she had chronic issue with inflammation and respiratory to begin with. So she called her doctor today to see if maybe she should do some Benadryl or something before, she went. she was nervous about taking the second shot because she had such a moderate reaction to the first shot (Further not confirmed hence captured as unspecified shot). The outcome of the events was unknown.  Follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Discoloured vomit, Dizziness, Faeces discoloured, Pyrexia
Clinical narrative: This is a spontaneous repot from a contactable consumer (patient's wife). A male patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date were unknown), on 19Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was vomiting black substance, having a black stool, fever, feeling dizzy and weak. Symptoms started on 22Mar2021. Asking if black stool and vomiting black substance was part of side effects of the vaccine and if he will be eligible for the 2nd dose. The outcome of the events was unknown.  No follow-up attempts are Possible. Information about lot/batch number cannot been obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: arm pain at the injection site; The injection site itched; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 69-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Mar2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 08Mar2021, patient received the first dose of the Pfizer COVID 19 vaccine and still having arm pain at the injection site. How long does the pain usually last. The injection site itched for a couple days after the shot. Patient was 69 years old. And asking Should he get the 2nd dose. The outcome of the event the injection site itched was unknown. The outcome of the event arm pain at the injection site was not recovered.  No follow-up attempts are possible; No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea, Headache, Influenza like illness, Muscle spasms
Clinical narrative: diarrhea; cramping; joint pain; nausea; achy all over; flu-like symptoms; headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient (Age 72; units: Unspecified) received first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number and Expiry date was not reported) via an unspecified route of administration on 17Mar2021 as dose 1, single for COVID-19 immunization. Medical history included asthma and diabetes mellitus. The patient concomitant medications were not reported. On 17Mar2021, patient had a slight headache, the next day (18Mar2021) she had a terrible headache, joint pain and nausea, she felt achy all over (flu-like symptoms) and she took Tylenol. On Friday she was fine but from Saturday until today (3 days) she had diarrhea and cramping. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain
Clinical narrative: diarrhea; cramping; joint pain; nausea; achy all over; flu-like symptoms; headache; This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient (Age 72; units: Unspecified) received first dose of bnt162b2(PFIZER-BIONTECH COVID -19 VACCINE, Solution for injection, Lot Number and Expiry date was not reported) via an unspecified route of administration on 17Mar2021 as dose 1, single for COVID-19 immunization. Medical history included asthma and diabetes mellitus. The patient concomitant medications were not reported. On 17Mar2021, patient had a slight headache, the next day (18Mar2021) she had a terrible headache, joint pain and nausea, she felt achy all over (flu-like symptoms) and she took Tylenol. On Friday she was fine but from Saturday until today (3 days) she had diarrhea and cramping. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Gout, X-ray limb
Clinical narrative: Left foot joint pain (gout) several days after receiving 1st vaccine shot; Left foot joint pain (gout) several days after receiving 1st vaccine shot; This is a spontaneous report from a contactable consumer (patient). A 48-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN 5318), via an unspecified route of administration, administered in Arm Left on 24Feb2021 15:30 (at the age of 48-year-old) as dose 1, single for COVID-19 immunization. The patient medical history was not reported. The patient had no allergies to medications, food, or other products. There were no concomitant medications. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and any other medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced left foot joint pain (gout) several days after receiving 1st vaccine shot. The patient had started to notice the adverse event on left foot on Monday, 01Mar2021. Monday, 01Mar2021 was when he had first noticed the adverse event (joint pain) on his left foot after he had received the 1st dose of Pfizer vaccine on Wednesday, 24Feb2021. The adverse event resulted in Doctor or other healthcare professional office/clinic visit and received treatment. The patient was prescribed Colchicine. The patient underwent lab test an procedure X-ray left foot on an unspecified date. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was not recovered.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: itch/itching after receiving the vaccine; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient).  A female patient of age 63 (units unknown) received bnt162b2 (COMIRNATY, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 20Mar2021 12:00 as dose 1, single for covid-19 immunization. Medical history and concomitant medications were not reported. Patient known allergies included as included penicillin allergy from an unknown date and unknown if ongoing. It is reported that, patient got Pfizer's covid vaccine on 20Mar2021 at noon and sat for the half hour to be monitored after the vaccine. On the same date 20Mar2021 at 5 pm, about 5 hours later, she had a slight itch and it was very mild. Outside of the itch, she has had no other symptoms and also stated it was now 48 hours after her first vaccination and the itching was very mild but she still has it. She does not know if the itch was related to the vaccine, it was not a side effect from what she understands. She did not have itching before the vaccine but has it after. Patient was asking that if she get the second one, as she heard the side effects could be worse with the second shot. She was not seeking medical advise but wanted to know if itching was a side effect of the vaccine. No Investigation Assessment was provided. The outcome of the event was not recovered.   No follow up attempts are possible. Information about Lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: face was all swollen up; This is a spontaneous report received from a contactable consumer. A 52-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot number and expiry date was not reported) via intramuscular, administered in Arm Right on 19Mar2021 11:45 as dose 1, single for covid-19 immunisation. The patient medical history and concomitant medication was not reported. On 20Mar2021 10:00, patient experienced Face swelled up. Patient wanted to know if facial swelling be an allergic reaction to the vaccine or is it something else. Patient went back to work and worked that night and went to bed and woke up the next day with his face totally swollen. He read the literature and it said facial swelling could be an effect. He is not on any other medications. Vaccination facility type was Hospital. NO ER or physician's office required. Patient did not received any vaccine Prior Vaccinations.. Outcome of the event was recovering.  Information about batch/lot number has been requested.  Follow-up (22Mar2021): This is a Follow-up spontaneous report from a contactable consumer. This male consumer (patient) reported that: Route of administration, Time of vaccination and time of AE was added. Case summary added.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Circumstance or information capable of leading to medication error, Pain, Pyrexia, SARS-CoV-2 antibody test
Clinical narrative: Scheduled for the second Pfizer Covid vaccine on 25March2021, caller canceled the appointment due to traveling; Body aches; Fever; Chills; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 04Mar2021 as 1st dose, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On 05Mar2021 the patient experienced body aches, fever, chills. scheduled for the second pfizer covid vaccine on 25march2021, patient canceled the appointment due to traveling. The following morning caller experienced body aches, fever & chills. Caller voiced that he previous spoke with someone about the symptoms, he needed to know about scheduling. Per caller he noticed in New York Times that if you have tested positive for Covid in the past you only need one vaccine. Asking if he only needs the one Pfizer Covid vaccine or both. The caller got the first dose last 04Mar and second dose was on 25Mar, however he wants to move his second dose to later date because he needs to be somewhere, more so he tested positive last year April of Covid and after his first shot he experienced the same symptoms of Covid like fever chills and body ache for 24 hours .The patient underwent lab tests and procedures which included sars-cov-2 antibody test: positive on he tested positive last year Apr of Covid. The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Chills
Clinical narrative: joint pain; chilling; This is a spontaneous report from a contactable consumer (patient's friend). A patient of unspecified age and gender received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose number unknown, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced joint pain and chilling on an unspecified date. Outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Influenza, Loss of personal independence in daily activities
Clinical narrative: I was so congested I thought I was getting a very bad cold or Flu.; I was so congested I thought I was getting a very bad cold or Flu.; I was so congested I thought I was getting a very bad cold or Flu.; And then for the next 9-days I had a very high fever; chills, body aches and So tired; chills, body aches and So tired; chills, body aches and So tired; my arm was sore; but was too sick to go to the doctors; I still do not feel back to my normal self; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old non-pregnant female patient received BNT162B29 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration in left arm on 05Mar2021 02:00 PM (at the age of 64-years-old) as dose 1, single for covid-19 immunization. The patients medical history include High Blood Pressure, Sinuses constantly, Chronic Pain. The patient concomitant medications (medications in two weeks) include buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE), methylphenidate hydrochloride (RITALIN), Lisinopril, Hydrochloride, drospirenone, ethinylestradiol (DIVA). Patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and was tested to COVID post vaccination. On 12Mar2021 patient had undergone with Nasal Swab test which resulted as negative. Patient had the 1st shot on Friday 05Mar2021, she was fine, Saturday 06Mar2021, her arm was sore, then Sunday 07Mar2021 09:30 AM when she woke up she could barely talk and she was so congested she thought she was getting a very bad cold or Flu. And then for the next 9-days she had a very high fever, chills, body aches and so tired she would have to sit down on the stairs in her house, and it just kept going on with no relief. she made a doctor appointment for 18Mar2021 but was too sick to go to the doctors. Patient still do not feel back to her normal self. She was afraid to get the 2nd shot on 26Mar2021, she called the health department in which where she received her 1st shot and was told to go to the appointment and let them know. And made a decision then, but she already know that she can't go through the side effects. Patient had not received any treatment for the events I was so congested I thought I was getting a very bad cold or Flu, chills, body aches and So tired, And then for the next 9-days I had a very high fever, my arm was sore. Outcome of events I was so congested I thought I was getting a very bad cold or Flu, chills, body aches and So tired, And then for the next 9-days I had a very high fever, my arm was sore recovering and for the events I still do not feel back to my normal self was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Pain, Pain in extremity, Pyrexia
Clinical narrative: I was so congested I thought I was getting a very bad cold or Flu.; I was so congested I thought I was getting a very bad cold or Flu.; I was so congested I thought I was getting a very bad cold or Flu.; And then for the next 9-days I had a very high fever; chills, body aches and So tired; chills, body aches and So tired; chills, body aches and So tired; my arm was sore; but was too sick to go to the doctors; I still do not feel back to my normal self; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old non-pregnant female patient received BNT162B29 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration in left arm on 05Mar2021 02:00 PM (at the age of 64-years-old) as dose 1, single for covid-19 immunization. The patients medical history include High Blood Pressure, Sinuses constantly, Chronic Pain. The patient concomitant medications (medications in two weeks) include buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE), methylphenidate hydrochloride (RITALIN), Lisinopril, Hydrochloride, drospirenone, ethinylestradiol (DIVA). Patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and was tested to COVID post vaccination. On 12Mar2021 patient had undergone with Nasal Swab test which resulted as negative. Patient had the 1st shot on Friday 05Mar2021, she was fine, Saturday 06Mar2021, her arm was sore, then Sunday 07Mar2021 09:30 AM when she woke up she could barely talk and she was so congested she thought she was getting a very bad cold or Flu. And then for the next 9-days she had a very high fever, chills, body aches and so tired she would have to sit down on the stairs in her house, and it just kept going on with no relief. she made a doctor appointment for 18Mar2021 but was too sick to go to the doctors. Patient still do not feel back to her normal self. She was afraid to get the 2nd shot on 26Mar2021, she called the health department in which where she received her 1st shot and was told to go to the appointment and let them know. And made a decision then, but she already know that she can't go through the side effects. Patient had not received any treatment for the events I was so congested I thought I was getting a very bad cold or Flu, chills, body aches and So tired, And then for the next 9-days I had a very high fever, my arm was sore. Outcome of events I was so congested I thought I was getting a very bad cold or Flu, chills, body aches and So tired, And then for the next 9-days I had a very high fever, my arm was sore recovering and for the events I still do not feel back to my normal self was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: I was so congested I thought I was getting a very bad cold or Flu.; I was so congested I thought I was getting a very bad cold or Flu.; I was so congested I thought I was getting a very bad cold or Flu.; And then for the next 9-days I had a very high fever; chills, body aches and So tired; chills, body aches and So tired; chills, body aches and So tired; my arm was sore; but was too sick to go to the doctors; I still do not feel back to my normal self; This is a spontaneous report from a contactable consumer (patient).  A 64-year-old non-pregnant female patient received BNT162B29 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number: not reported), dose 1 via an unspecified route of administration in left arm on 05Mar2021 02:00 PM (at the age of 64-years-old) as dose 1, single for covid-19 immunization. The patients medical history include High Blood Pressure, Sinuses constantly, Chronic Pain. The patient concomitant medications (medications in two weeks) include buprenorphine hydrochloride, naloxone hydrochloride (SUBOXONE), methylphenidate hydrochloride (RITALIN), Lisinopril, Hydrochloride, drospirenone, ethinylestradiol (DIVA). Patient had no known allergies. The patient was not pregnant at the time of vaccination. The patient had not received any other vaccines within 4 weeks prior to the COVID vaccine and was tested to COVID post vaccination. On 12Mar2021 patient had undergone with Nasal Swab test which resulted as negative. Patient had the 1st shot on Friday 05Mar2021, she was fine, Saturday 06Mar2021, her arm was sore, then Sunday 07Mar2021 09:30 AM when she woke up she could barely talk and she was so congested she thought she was getting a very bad cold or Flu. And then for the next 9-days she had a very high fever, chills, body aches and so tired she would have to sit down on the stairs in her house, and it just kept going on with no relief. she made a doctor appointment for 18Mar2021 but was too sick to go to the doctors. Patient still do not feel back to her normal self. She was afraid to get the 2nd shot on 26Mar2021, she called the health department in which where she received her 1st shot and was told to go to the appointment and let them know. And made a decision then, but she already know that she can't go through the side effects. Patient had not received any treatment for the events I was so congested I thought I was getting a very bad cold or Flu, chills, body aches and So tired, And then for the next 9-days I had a very high fever, my arm was sore. Outcome of events I was so congested I thought I was getting a very bad cold or Flu, chills, body aches and So tired, And then for the next 9-days I had a very high fever, my arm was sore recovering and for the events I still do not feel back to my normal self was unknown.   No follow-up attempts are needed. Information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Dyspnoea, Fatigue
Clinical narrative: dizziness; tiredness; headaches; body pains; muscle aches and pain; chills; fever; nausea; some vomiting; rapid heart beats; breathing problems; Soreness in arm; This is a spontaneous report from a contactable consumer or other non hcp (patient himself) via medical information team and Pfizer- sponsored program  Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on 17Mar2021 16:30, as dose 1, single for COVID-19 immunization. Medical history included Seasonal asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 19Mar2021, the patient experienced tiredness, headaches, body pains, muscle aches and pain, chills, fever, nausea, some vomiting, rapid heartbeats, breathing problems, on an unspecified date in Mar2021, experienced soreness in arm and on an unspecified date, experienced dizziness. The caller went to work Thursday and Friday and there were no problems. Friday night it started going downhill. The patient underwent lab tests and procedures which included body temperature: 102 on unspecified date in Mar2021 and it came down to 98. The outcome for tiredness, body pains, chills, fever, nausea, some vomiting, rapid heartbeats, breathing problems, soreness in arm and dizziness was unknown. The outcome of events headaches, muscle aches and pain were not recovered. The outcome for fever was recovered on unspecified date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021316682 same reporter/drug/event, diff patients
Sex: M
Vaccine: COVID19
Symptoms: Headache, Heart rate increased, Myalgia, Nausea, Pain
Clinical narrative: dizziness; tiredness; headaches; body pains; muscle aches and pain; chills; fever; nausea; some vomiting; rapid heart beats; breathing problems; Soreness in arm; This is a spontaneous report from a contactable consumer or other non hcp (patient himself) via medical information team and Pfizer- sponsored program  Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on 17Mar2021 16:30, as dose 1, single for COVID-19 immunization. Medical history included Seasonal asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 19Mar2021, the patient experienced tiredness, headaches, body pains, muscle aches and pain, chills, fever, nausea, some vomiting, rapid heartbeats, breathing problems, on an unspecified date in Mar2021, experienced soreness in arm and on an unspecified date, experienced dizziness. The caller went to work Thursday and Friday and there were no problems. Friday night it started going downhill. The patient underwent lab tests and procedures which included body temperature: 102 on unspecified date in Mar2021 and it came down to 98. The outcome for tiredness, body pains, chills, fever, nausea, some vomiting, rapid heartbeats, breathing problems, soreness in arm and dizziness was unknown. The outcome of events headaches, muscle aches and pain were not recovered. The outcome for fever was recovered on unspecified date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021316682 same reporter/drug/event, diff patients
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Pyrexia, Vomiting
Clinical narrative: dizziness; tiredness; headaches; body pains; muscle aches and pain; chills; fever; nausea; some vomiting; rapid heart beats; breathing problems; Soreness in arm; This is a spontaneous report from a contactable consumer or other non hcp (patient himself) via medical information team and Pfizer- sponsored program  Support. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number was not reported, Expiry date: Unknown) via an unspecified route of administration on 17Mar2021 16:30, as dose 1, single for COVID-19 immunization. Medical history included Seasonal asthma from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On 19Mar2021, the patient experienced tiredness, headaches, body pains, muscle aches and pain, chills, fever, nausea, some vomiting, rapid heartbeats, breathing problems, on an unspecified date in Mar2021, experienced soreness in arm and on an unspecified date, experienced dizziness. The caller went to work Thursday and Friday and there were no problems. Friday night it started going downhill. The patient underwent lab tests and procedures which included body temperature: 102 on unspecified date in Mar2021 and it came down to 98. The outcome for tiredness, body pains, chills, fever, nausea, some vomiting, rapid heartbeats, breathing problems, soreness in arm and dizziness was unknown. The outcome of events headaches, muscle aches and pain were not recovered. The outcome for fever was recovered on unspecified date in Mar2021.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.; Sender's Comments: Linked Report(s) : -PFIZER INC-2021316682 same reporter/drug/event, diff patients