chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylactic shock; A spontaneous report was received from a consumer who is also a 71-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced anaphylaxis.  The patient's medical history was not included. Products known to have been used by the patient were not provided.  On 27 Jan 2021, prior to the onset of the events, the patient received the first of two planned doses of mRNA-1273 (Lot number: 029L20A) intramuscularly for prophylaxis of COVID-19 infection.    On 27 Jan 2021, after the mRNA-1273 vaccine was being given, the patient noted anaphylaxis symptoms, was rushed to the hospital and hospitalized for 24 hours.  Treatment information included hospitalization, epinephrine and breathing treatments.   Action taken with mRNA-1273 will be discussed with her physician.  The outcome of the event anaphylaxis was unknown.; Reporter's Comments: This case concerns a 71-year-old female patient. The medical history is not provided. The patient experienced a serious unexpected event of Anaphylactic reaction on the same day after receiving their first of two planned doses of mRNA-1273 (Lot # 029L20A). Treatment included epinephrine and breathing treatments. Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded and the event is considered possibly related to the vaccine.
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fall, Hip fracture, SARS-CoV-2 test positive
Clinical narrative: Broke Hip at Assisted Living; Fell; Tested positive for COVID-19; A spontaneous report was received from a daughter concerning a 88-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and fell and fractured hip, and tested positive for COVID-19.  The patient's medical history, as provided by the reporter, included Alzheimer's and behavioral problems. The patient's medical history was not provided. No relevant concomitant medications were reported.   On 12 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 23 Jan 2021, the patient fell and fractured her hip at her assisted living facility, and was hospitalized. Treatment for hip fracture was not provided.  On 29 Jan 2021, at the hospital, she subsequently tested positive for COVID-19. Treatment included oxygen through 30 Jan 2021. On 01 Feb 2021, it was reported that the patient was not on a ventilator.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of the events fell and fractured hip and tested positive for COVID-19 were unknown at the time of this report.; Reporter's Comments: This case concerns a 88 year old female with medical history of Alzheimer's and behavioral problems, who experienced a serious unexpected events of fall and hip fracture 12 days after the first dose of mRNA-1273. Information on treatment not provided.  On 29-Dec-2021, she had a serious unexpected event of COVID-19 18 days after mRNA-1273, requiring supplemental oxygen. Based on the current available information and temporal association between the of the product and the start date of the events, a causal relationship cannot be excluded.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Death, SARS-CoV-2 test positive
Clinical narrative: Passed away; Positive result; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and developed COVID-19 and passed away.    The patient's medical history was not provided. Concomitant product use was not reported.  On 05 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On 08 Jan 2021, the patient had a positive COVID-19 test.  On 18 Jan 2021, the patient passed away. No treatment information was provided.   Action taken with mRNA-1273 in response to the events was not applicable.  The patient died on 18 Jan 2021. The cause of death was not reported.; Reporter's Comments: This spontaneous report concerns a female patient who experienced COVID-19 and passed away. The event of COVID-19 occurred 4 days after the first and only dose of the mRNA-1273 vaccine administered and death occurred 14 days after administration of the mRNA-1273 vaccine.  Based on the information provided and the known etiology of  COVID-19, it is unlikely to be associated with mRNA-1273 vaccine administration. With no definite information on the clinical details of the death, it is difficult to adequately assess a causal association with mRNA vaccine.  Main field defaults to possibly related'; Reported Cause(s) of Death: unknown cause of death
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Lip swelling, Myalgia, Nausea
Clinical narrative: Severe lip swelling; Body rash; Chills, rigors; Muscle aches; Nausea; Generalized weakness; This is a spontaneous report from a contactable physician (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Arm Left on 11Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: EK5730. Medical history and concomitant medications were not provided. Patient had no known allergies. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at Left arm for COVID-19 immunisation, lot number: ELO142. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 14Jan2021 at 04:00 PM patient experienced severe lip swelling, body rash, chills, rigors, muscle aches, nausea, generalized weakness. The events were treated with fexofenadine hydrochloride (ALLEGRA), diphenhydramine hydrochloride (BENADRYL) and presnosone. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient had not tested for COVID-19 since having the vaccine. Patient was recovering from the events, at the time of the report.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Severe lip swelling; Body rash; Chills, rigors; Muscle aches; Nausea; Generalized weakness; This is a spontaneous report from a contactable physician (patient). A 52-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration Arm Left on 11Jan2021 at 01:00 PM as a single dose for COVID-19 immunisation, lot number: EK5730. Medical history and concomitant medications were not provided. Patient had no known allergies. Patient received first vaccine dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 22Dec2020 at Left arm for COVID-19 immunisation, lot number: ELO142. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 14Jan2021 at 04:00 PM patient experienced severe lip swelling, body rash, chills, rigors, muscle aches, nausea, generalized weakness. The events were treated with fexofenadine hydrochloride (ALLEGRA), diphenhydramine hydrochloride (BENADRYL) and presnosone. Events resulted in Doctor or other healthcare professional office/clinic visit. Patient had not tested for COVID-19 since having the vaccine. Patient was recovering from the events, at the time of the report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Pain
Clinical narrative: Fever of 102 degrees; Chills/rigors; Fatigue; Headache; Body aches; Injection site redness; Injection site pain; Injection site swelling; This is a spontaneous report from a contactable healthcare professional. A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9262, via an unspecified route of administration at left arm on 22Jan2021 13:00 at a single dose for COVID-19 immunisation. Medical history included allergy to metals, cervix carcinoma from 2014, hysterectomy from 2014, chemotherapy from 2014, radiotherapy from 2014, Lyme disease from 1991 and mononucleosis from 1980's. Concomitant medication included bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]). The patient previously took codeine and experienced allergy. Historical vaccine included first dose of bnt162b2 on 22Dec2020. On 23Jan2021, the patient experienced fever of 102 degrees, chills, rigors, fatigue, headache, body aches, injection site redness, injection site pain and injection site swelling. The patient took ibuprofen as rest as treatment. The outcome of the events was recovering.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Fever of 102 degrees; Chills/rigors; Fatigue; Headache; Body aches; Injection site redness; Injection site pain; Injection site swelling; This is a spontaneous report from a contactable healthcare professional. A 50-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) lot number: EL9262, via an unspecified route of administration at left arm on 22Jan2021 13:00 at a single dose for COVID-19 immunisation. Medical history included allergy to metals, cervix carcinoma from 2014, hysterectomy from 2014, chemotherapy from 2014, radiotherapy from 2014, Lyme disease from 1991 and mononucleosis from 1980's. Concomitant medication included bifidobacterium lactis (PROBIOTIC [BIFIDOBACTERIUM LACTIS]). The patient previously took codeine and experienced allergy. Historical vaccine included first dose of bnt162b2 on 22Dec2020. On 23Jan2021, the patient experienced fever of 102 degrees, chills, rigors, fatigue, headache, body aches, injection site redness, injection site pain and injection site swelling. The patient took ibuprofen as rest as treatment. The outcome of the events was recovering.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received their first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date not reported), via an unspecified route of administration on 06Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient experienced shingles on an unspecified date. Therapeutic measures were taken as a result of shingles which included treatment with acyclovir. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Chills, Fatigue, Headache
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number unknown), via an unspecified route of administration on 22Jan2021 at 14:00 (at the age of 65-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included Covid in Mar2020 during which the patient suffered with symptoms and fever for 17 days followed by several weeks of feeling weak. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jan2021 at 19:00, after taking the first dose,  the patient experienced tiredness, joint pain, headache, muscle pain, chills, fever of 101.5, and nausea, which the patient stated were the same symptoms the patient had experienced when the patient was diagnosed with COVID-19 in Mar2020. The patient did not receive any treatment for the events. The patient sated these symptoms lasted 2 1/2 days until temp was normal and symptoms started to fade. The clinical outcome of fever was recovered on an unknown date in 2021.The clinical outcomes of tiredness, joint pain, headache, muscle pain, chills, nausea were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 65-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot number unknown), via an unspecified route of administration on 22Jan2021 at 14:00 (at the age of 65-years-old) as a single dose in the left arm for COVID-19 immunization. Medical history included Covid in Mar2020 during which the patient suffered with symptoms and fever for 17 days followed by several weeks of feeling weak. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unknown date in Jan2021 at 19:00, after taking the first dose,  the patient experienced tiredness, joint pain, headache, muscle pain, chills, fever of 101.5, and nausea, which the patient stated were the same symptoms the patient had experienced when the patient was diagnosed with COVID-19 in Mar2020. The patient did not receive any treatment for the events. The patient sated these symptoms lasted 2 1/2 days until temp was normal and symptoms started to fade. The clinical outcome of fever was recovered on an unknown date in 2021.The clinical outcomes of tiredness, joint pain, headache, muscle pain, chills, nausea were recovering. It was also reported that since the vaccination, the patient had not been tested for COVID-19.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, SARS-CoV-2 test
Clinical narrative: started menstrual cycle after not having it for 8+ years; This is a spontaneous report from a contactable Healthcare Professional, the patient. A 59-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3302), via an unspecified route of administration in the left arm on 18Jan2021 at 10:00 (at the age of 59-years) as a single dose for COVID-19 immunization. Medical history included asthma, diabetic, and known allergies to all penicillin's and macadamia nuts. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included dulaglutide (TRULICITY), metformin, bupropion hydrochloride (WELLBUTRIN), trazodone, terbinafine hydrochloride (LAMATER). The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 21Jan2021 at 16:00, the patient reported her menstrual cycle started after not having it for 8+ years. Post vaccination, on 25Jan2021 the patient was tested for COVID-19 via nasal swab with an unknown result. The clinical outcome of the event, menstrual cycle started after not having it for 8+ years, was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Malaise, Oropharyngeal pain
Clinical narrative: This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on 24Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient received 1st dose of the COVID-19 vaccine "yesterday" (24Jan2021) and developed severe sore throat in the middle of the night (Jan2021). The patient woke up last night with a severe sore throat, and "today" (25Jan2021), about 18 hours after getting the vaccine, the patient developed headache and malaise, also reported as "body malaise," and generally didn't feel well. The outcome of the events severe sore throat, headache, malaise/body malaise, and generally didn't feel well was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Joint effusion, Lymphadenopathy, Peripheral swelling
Clinical narrative: The left calf is swollen 3/4 inch; Left knee effusion/ she got the Bakers cyst test, the fluid leaked into the area that formed into this area; swollen cervical and supraclavicular lymph nodes on the left side/ swollen axillary lymph nodes on both sides; This is a spontaneous report from a contactable healthcare professional (Physician Assistant) reporting for self. A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), Lot# EL0142, Dose 1, intramuscularly on 07Jan2021 07:15 (at the age of 48 years old) as a single dose in left arm for COVID-19 immunization.  Medical history included ongoing undifferentiated spondyloarthropathy diagnosed more than 10 years ago.  Concomitant medication included golimumab (SIMPONI), 0.5mg subcutaneous injection once a month for undifferentiated spondyloarthropathy.  There were no prior vaccinations in the past 4 weeks. There were no adverse events with prior vaccinations. Two days after the vaccine on 09Jan2021 she experienced swollen cervical and supraclavicular lymph nodes on the left side. On 12Jan2021 by 09:00 she developed left knee effusion and swollen axillary lymph nodes on both sides. It was worse "now" (as of Jan252021); she states she got the Bakers cyst test, the fluid leaked into the area that formed into this area. On an unspecified date, the left calf was swollen 3/4 inch. The events did not require a visit to the Emergency Room. The events did require a visit to her rheumatologist on Friday, 22Jan2021. There reporter declined having had treatment for the events. The outcome of the left knee effusion was not recovered; left knee effusion was reported as worsened. The outcome of swollen on axillary lymph nodes on both sides, swollen cervical and supraclavicular lymph nodes on the left side was recovering. The outcome of left calf was swollen 3/4 inch was unknown. Her rheumatologist was asking if he can drain it or send fluid for any studies prior to any treatment, and for any advice or if any special markers need to be drawn in case Pfizer would like more information on this.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Nausea, Pain in extremity, Vaccination site pain
Clinical narrative: back pain/soreness in his lower back/had bad lower back pain; injection site pain on his arm that traveled to his shoulder; joint pain/injection site pain on his arm that traveled to his shoulder; nausea; had a sore left arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiration date not provided), via an unspecified route of administration in his left arm on 19Jan2021 at single dose for COVID-19 immunization. Medical history included PTSD (Post-traumatic stress disorder), anxiety, is a disabled veteran, has had different cancers, had stage III lung cancer, brain surgery and brain cancer before the Covid vaccine. The patient's concomitant medications reported as he had great medicines and was doing good that. The patient reported that on 23Jan2021 he started having a lot of back pain/soreness in his lower back. He stated on the day he received the injection, he experienced injection site pain on his arm on 19Jan2021 that traveled to his shoulder. He also reported having nausea and joint pain since the vaccine on 19Jan2021. Patient stated that his arm was sore where he got the shot, had a sore left arm on 19Jan2021. Stated day before yesterday (23Jan2021) noticed travelled down arm. Stated that he had bad lower back pain, he never had back pain before. Stated that it hit him all at once the day before yesterday (23Jan2021). The outcome of the events was unknown. Serious reported as no.  Information on the lot/batch number has been requested.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Skin disorder
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for her husband. A 65-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 24Jan2021 at 05:44 PM or 05:45 PM (at the age of 65 years old) as a single dose in the arm for COVID-19 IMMUNIZATION. Relevant medical history was not provided. The concomitant medication included acetylsalicylic acid (ECOTRIN) 81mg, potassium chloride (KLOR-CON M10) 750 mg, 2x/day, olmesartan 40-25 mg, 1x/day, rosuvastatin calcium 5mg and other non-prescribed supplements. On 24Jan2021, the patient experienced bump in his arm and was a little stiff and sore. The patient did not receive any treatment for these events. The outcome of the events bump in his arm and was a little stiff and sore was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Underdose, Vaccination site pain
Clinical narrative: she stated that the injection hurt; coughing a lot; when the nurse pulled out the needle she continued to shoot out some vaccine left in the syringe; from a Pfizer-sponsored program. A contactable consumer (patient). This 41-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on an unspecified date for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that the injection hurt and when the nurse pulled out the needle she continued to shoot out some vaccine left in the syringe, coughing a lot on an unspecified date with outcome of unknown. She is asking if she should get a third vaccine.   Information of lot/batch number has been requested.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Asthma, Cough, Dyspnoea, Fatigue
Clinical narrative: awoke to not being able to breathe; coughing in my sleep most of the night; I ended up having to go sit up in a chair until my wheezing stopped; I was very fatigued; my insides hurt, my stomach was nauseated; my insides hurt, my stomach was nauseated; asthma; I had a headache; I felt sick; This is a spontaneous report from a contactable consumer, the patient. This 47- year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248),  dose  1 , single dose via an unspecified route of administration in the right arm on 21Jan2021 at 01:45 PM (at the age of 47- years-old) for COVID-19 vaccination.  Medical history included asthma, seasonal allergies, allergy to general anesthetic and melon and hiatal hernia. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included albuterol inhaler and pantoprazole. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 21Jan2021 at 07:00 PM the patient had a headache. She went to bed and the next day, (Friday 22Jan2021) was very fatigued, had a pounding headache,  insides hurt, stomach was nauseated and had trouble with asthma. In the early morning hours of Saturday, 23Jan2021 at 2:30am, she awoke to not being able to breathe. She  had to use her rescue inhaler 3 times & her husband said she was coughing in her sleep most of the night. She ended up having to go sit up in a chair until the wheezing stopped and she could breathe again. She had to drink a Tea to help clear her lungs. She felt sick until Saturday afternoon, 23Jan2021. Treatment received for asthma  and not being able to breathe included a rescue inhaler. The clinical outcome of  asthma, not able to breathe, headache, fatigued, insides hurt, stomach was nauseated,  wheezing and coughing was recovered on an unknown date in Jan2021 and recovered on 23Jan2021 for sick. Treatment was not received for events headache, fatigued, insides hurt, stomach was nauseated, sick, wheezing and coughing.  It was also reported that since the vaccination, the patient had not  been tested for COVID-19.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Illness, Nausea, Wheezing
Clinical narrative: awoke to not being able to breathe; coughing in my sleep most of the night; I ended up having to go sit up in a chair until my wheezing stopped; I was very fatigued; my insides hurt, my stomach was nauseated; my insides hurt, my stomach was nauseated; asthma; I had a headache; I felt sick; This is a spontaneous report from a contactable consumer, the patient. This 47- year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EL3248),  dose  1 , single dose via an unspecified route of administration in the right arm on 21Jan2021 at 01:45 PM (at the age of 47- years-old) for COVID-19 vaccination.  Medical history included asthma, seasonal allergies, allergy to general anesthetic and melon and hiatal hernia. The patient was not pregnant at the time of vaccination.  Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included albuterol inhaler and pantoprazole. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. On 21Jan2021 at 07:00 PM the patient had a headache. She went to bed and the next day, (Friday 22Jan2021) was very fatigued, had a pounding headache,  insides hurt, stomach was nauseated and had trouble with asthma. In the early morning hours of Saturday, 23Jan2021 at 2:30am, she awoke to not being able to breathe. She  had to use her rescue inhaler 3 times & her husband said she was coughing in her sleep most of the night. She ended up having to go sit up in a chair until the wheezing stopped and she could breathe again. She had to drink a Tea to help clear her lungs. She felt sick until Saturday afternoon, 23Jan2021. Treatment received for asthma  and not being able to breathe included a rescue inhaler. The clinical outcome of  asthma, not able to breathe, headache, fatigued, insides hurt, stomach was nauseated,  wheezing and coughing was recovered on an unknown date in Jan2021 and recovered on 23Jan2021 for sick. Treatment was not received for events headache, fatigued, insides hurt, stomach was nauseated, sick, wheezing and coughing.  It was also reported that since the vaccination, the patient had not  been tested for COVID-19.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Inappropriate schedule of product administration, Lethargy
Clinical narrative: This is a spontaneous report received from a contactable physician (who is also the patient). A 33-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm, on 18Jan2021 08:00 (lot number: el3248, expiry date: unknown), at single dose; and received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular in the left arm, on 18Jan2021 14:00 (lot number: EL0140, expiry date: unknown), at single dose, for covid-19 immunization, at the hospital (this was also reported as received the first dose on 18Jan2021 14:00 and the second dose on 18Jan2021 08:00, pending clarification). The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the BNT162B2 vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination. The patient experienced shoulder tenderness, joint pain, chills and lethargy on 18Jan2021 at 17:30. No treatment was given for the events. The patient recovered from the events on an unspecified date. The events were assessed as non-serious.  No follow-ups attempts are possible. No further information is expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Pruritus, Rash
Clinical narrative: Cough; itchy; getting rashes; This is a spontaneous report from a contactable consumer. An 84-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL9261), via an unspecified route of administration on 22Jan2021 at single dose at arm right for COVID-19 immunization. Medical history included Reflux, and fatty tumor. Concomitant medication included pantoprazole from 11Jan2021 and ongoing for reflux. On 24Jan2021, the patient experienced itchy, getting rashes. On an unspecified date, the patient experienced cough. The outcome of the event cough was not recovered while unknown for the other events. Therapeutic measures were taken as a result of itchy (pruritus), getting rashes (rash), cough (cough).
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Dysphagia, Ear pain, Headache, Pharyngeal swelling, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer. A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: 31May2021), via an unspecified route of administration on 21Jan2021, 09:30 at a single dose on left arm for COVID-19 immunization. Medical history included oesophageal dilation procedure from 11Jan2021 to an unknown date and had trouble swallowing from an unknown date and unknown if ongoing. There were no concomitant medications. The patient received the first dose of the vaccine on 21Jan2021 and everything was pretty good. Nothing bothered her until yesterday, Sunday morning. Her throat is not sore but swollen. She feels it is in her tonsils, like her tonsils are swollen. When she gets ready to swallow it is hard sometimes, she can swallow but it feels like something is in the back of her throat like her tonsils are swollen. She has had headaches off and on. She asked if these were normal symptoms after the vaccine. Reported her second COVID-19 Vaccine is scheduled for 11Feb2021 at 9:30AM. Reported she had 3 negative COVID-19 virus tests before. She said each time she had the COVID-19 virus test done was before a scheduled procedure. She said her last negative COVID-19 virus test was on 08Jan2021 before a procedure on 11Jan2021. She clarified she had trouble swallowing and had an esophageal dilation on 11Jan2021. She said she was put to sleep for the procedure. Clarified she has had an off and on headache, a sore throat that feels like her tonsils are swollen, and a pain that shoots through her ear occasionally. She said all her symptoms started late on Saturday (23Jan2021) or early Sunday (24Jan2021). Reported she took 1 Tylenol Extra Strength 500mg capsule yesterday evening (24Jan2021). She said she does not have the box with the UPC number for the Tylenol Extra Strength 500mg capsule, providing: Lot Number: PBA023, and Expiration Date: Dec2022. Reported she left her COVID-19 vaccine paperwork at her daughter's house. She said her daughter read some of the COVID-19 vaccine side effects over the phone to her, but sore throat wasn't one of the listed vaccine side effects. She said she was calling Pfizer to find out if a sore throat was a side effect of the COVID-19 vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Jan2021. More information available (Y/N): No. Therapeutic measures were taken as a result of throat is not sore but swollen, headaches off and on and pain that shoots through her ear occasionally. The outcome of the event "throat is not sore but swollen", "headaches off and on" and "pain that shoots through her ear occasionally" was not recovered while of the other events was unknown.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Tonsillar hypertrophy
Clinical narrative: This is a spontaneous report from a contactable consumer. A 91-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3249, expiry date: 31May2021), via an unspecified route of administration on 21Jan2021, 09:30 at a single dose on left arm for COVID-19 immunization. Medical history included oesophageal dilation procedure from 11Jan2021 to an unknown date and had trouble swallowing from an unknown date and unknown if ongoing. There were no concomitant medications. The patient received the first dose of the vaccine on 21Jan2021 and everything was pretty good. Nothing bothered her until yesterday, Sunday morning. Her throat is not sore but swollen. She feels it is in her tonsils, like her tonsils are swollen. When she gets ready to swallow it is hard sometimes, she can swallow but it feels like something is in the back of her throat like her tonsils are swollen. She has had headaches off and on. She asked if these were normal symptoms after the vaccine. Reported her second COVID-19 Vaccine is scheduled for 11Feb2021 at 9:30AM. Reported she had 3 negative COVID-19 virus tests before. She said each time she had the COVID-19 virus test done was before a scheduled procedure. She said her last negative COVID-19 virus test was on 08Jan2021 before a procedure on 11Jan2021. She clarified she had trouble swallowing and had an esophageal dilation on 11Jan2021. She said she was put to sleep for the procedure. Clarified she has had an off and on headache, a sore throat that feels like her tonsils are swollen, and a pain that shoots through her ear occasionally. She said all her symptoms started late on Saturday (23Jan2021) or early Sunday (24Jan2021). Reported she took 1 Tylenol Extra Strength 500mg capsule yesterday evening (24Jan2021). She said she does not have the box with the UPC number for the Tylenol Extra Strength 500mg capsule, providing: Lot Number: PBA023, and Expiration Date: Dec2022. Reported she left her COVID-19 vaccine paperwork at her daughter's house. She said her daughter read some of the COVID-19 vaccine side effects over the phone to her, but sore throat wasn't one of the listed vaccine side effects. She said she was calling Pfizer to find out if a sore throat was a side effect of the COVID-19 vaccine. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 08Jan2021. More information available (Y/N): No. Therapeutic measures were taken as a result of throat is not sore but swollen, headaches off and on and pain that shoots through her ear occasionally. The outcome of the event "throat is not sore but swollen", "headaches off and on" and "pain that shoots through her ear occasionally" was not recovered while of the other events was unknown.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: This is a spontaneous report from a contactable healthcare professional, the patient. A 49-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number EL3246), via an unspecified route of administration on 18Jan2021 at 09:00 (at the age of 49-years-old) as a single dose in the right arm for COVID-19 vaccination. Medical history included high blood pressure and tachycardia. The patient does not have allergies to medications, food, or other products. The vaccination was administered to the patient in a hospital. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient had not received any other vaccines within four weeks prior to the COVID vaccine. The patient's historical vaccinations include the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot number Unknown) on an unspecified date. Concomitant medications were not reported. On 18Jan2021 at 15:00 (reported as six hours after the shot), the patient experienced a headache. On 18Jan2021 at 21:00 (reported as twelve hours post shot) the patient experienced chills. The patient did not receive any treatment for the events. The clinical outcomes of headache and chills were reported as not recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus, Rash, Urticaria
Clinical narrative: This is a spontaneous report from a contactable nurse (patient). A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot EL1283, expiration date 30Apr2021), via an unspecified route of administration on 21Jan2021 14:00 at single dose for COVID-19 immunization. The patient had no medical history and no concomitant medications. Patient stated she took the first dose of the vaccine on 21Jan2021 at 14:00 and she felt fine, no problem at all. On 21Jan2021, her arm felt "a little sore" after and then at 21:00 she experienced a lower back rash and itching that resulted in a 1/4-inch-high welt that was about 3 inches long. Her back was itchy and it was just like lower back and she looked in the mirror and had a little bit of a rash back there and just like kind of like one small welt. Her husband (physician), said that it looks like she have a little bite there but she do not think she had a bite. Patient was trying to decide that possibly and that was many hours later from 2-9, she noticed that and it was odd to get a rash on lower back as allergic reaction as it was usually on the trunk and forearms. The patient described welt as a raised area something like rash. There was like one small welt and then there was an area kind of raised and red and itchy. She took Benadryl to treat the symptom and was asking if she should go ahead and take the second dose of the vaccine. Patient was asking if she can pre-medicate with Benadryl for her second dose of the vaccine. Outcome of events was unknown.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Nausea, Pain in extremity
Clinical narrative: Left arm shoulder pain and severe nausea began about 12 hours afer vaccine and lasted for approx another 16 hours; Left arm shoulder pain and severe nausea began about 12 hours afer vaccine and lasted for approx another 16 hours; Severe Burning from neck, through arm, and down side immediately after injection lasting about 20 minutes; Left arm shoulder pain and severe nausea began about 12 hours afer vaccine and lasted for approx another 16 hours; This is a spontaneous report from a contactable other health care professional, the patient.  A non-pregnant 44-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EL1283), intramuscular  in the left arm on 20Jan2021 at 09:30 AM (at the age of 44-year-old) as a single dose for COVID-19 immunization. The patient medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication taken within two weeks of vaccination included hydroxyzine pamoate and multivitamins. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On 20Jan2021 at 09:30 AM, the patient experienced severe burning from neck, through arm, and down side immediately after injection lasting about 20 minutes. Left arm shoulder pain and severe nausea began about 12 hours after vaccine and lasted for approximately another 16 hours. The events were reported as non-serious. The patient did not receive any treatment for the events. The clinical outcome of severe burning from neck, through arm, and down side immediately after injection lasting about 20 minutes, Left arm shoulder pain and severe nausea began about 12 hours after vaccine and lasted for approximately another 16 hours was recovered. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Lip swelling, Swelling face
Clinical narrative: allergic reaction; severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip; severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip; This is a spontaneous report from a contactable consumer (patient). A 48-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration, first dose on 30Dec2020 at 09:00 (Lot number: EL0140) in the right arm and second dose on 20Jan2021 (Lot number: EL3246) in the left arm, both at the age of 48-years-old at a single dose for COVID-19 immunization. Medical history included low vitamin D, hypothyroid, Von Willebrand's, and idiopathic anaphylaxis (years ago, outgrew). The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included unspecified medications within two weeks of vaccination. The patient previously received botulinum toxin type A (BOTOX) in the forehead years ago. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip and allergic reaction on 31Dec2020. The events were reported as non-serious. The clinical course was reported as: The patient woke up with severe lip/facial swelling on left side of face and top lip. The patient went to doctor and they thought it was allergic reaction, but not sure if it was the vaccine. After the patient received the second dose, she had swelling two days later on right bottom side of face and lip. The patient had no lip/facial filler. The patient did not receive any treatment for the events. The clinical outcome of severe lip/facial swelling on left side of face and top lip/swelling two days later on right bottom side of face and lip and allergic reaction was recovered in Jan2021. It was also reported that since the vaccination, the patient had not been tested for COVID-19.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus/ringing in ears; This is a spontaneous report from a contactable consumer (patient). A 72-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: ELI284; Expiration date was not reported) on 14Jan2021 (10:00) at a single dose on the left arm, with route of administration unspecified, for COVID-19 immunization at the hospital. Medical history included Sjogren's syndrome. The patient's concomitant medications included unspecified vitamins. The patient previously took codeine, and had drug allergy. On 16Jan2021 (02:00), the patient had tinnitus/ringing in ears which had not gone away after ten days. The patient did not receive any treatment for the reported event. The outcome of the event, tinnitus/ringing in ears, was not recovered. The patient was not diagnosed with COVID-19 prior to the vaccination, and had not been tested since the vaccination.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site swelling
Clinical narrative: Swelling and tenderness at vaccine site; Swelling and tenderness at vaccine site; This is a spontaneous report from a contactable non-healthcare professional reported for herself that. This 33-year-old female patient received the 1st dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL 3247) via an unspecified route of administration at left arm on 22Jan2021 02:00 PM at single dose for COVID-19 immunization. Medical history included hypothyroidism and seasonal allergies. The patient had no allergies to medications, food, or other products. Concomitant medications included levothyroxine sodium (SYNTHROID), BUSPIRONE HYDROCHLORIDE (BUSPAR), fluticasone propionate (FLONASE), cetirizine hydrochloride (ZYRTEC), and birth control. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at the time of vaccination. The patient experienced swelling and tenderness at vaccine site on 23Jan2021 06:00 AM. No treatment was received for the adverse events.  Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Outcome of the events was recovering. Seriousness criteria was reported as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable Nurse. A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 14Jan2021 04:45 at a single dose for COVID-19 immunization. The patient's medical history included heart attack, a history of diabetes and hypertension. Concomitant medications were not reported. On 18Jan2021, the patient experienced chills and temperature 100.1. The outcome of the event was recovering.  Information on the Lot/Batch number has been requested.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Feeling abnormal, Headache, Malaise
Clinical narrative: tightening and swelling in her throat; tightening and swelling in her throat; slight swelling of the tongue; panicky, uncomfortable feeling; panicky, uncomfortable feeling; headache; Sore throat; Extreme tiredness; achy joints; sore muscles; generally feeling sick/unwell; This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration at right arm on 23Jan2021 13:30 at a single dose for  COVID-19 immunization.  Medical history included ongoing hypothyroidism (has had for 15 years or so). The patient's concomitant medications were not reported. The patient previously took glycerin and had allergy (has been allergic to glycerin for at least ten years). The patient received the Covid-19 vaccine on Saturday. About 10-15 seconds after receiving it, she felt like it was moving up her arm. She also had a headache and sore throat on the same day. About 20 minutes later at 13:50, she had a tightening and swelling in her throat. It was a panicky, uncomfortable feeling. She reported a "narrowing of my airway" and slight swelling of the tongue/back-of throat. She was unsure if she should wait or go to the emergency room. She took some deep breaths and waited it out. It went away 40 minutes later. She also reported feeling extreme tiredness, achy joints, sore muscles, a headache, and generally feeling sick/unwell in Jan2021. The events did not require a visit to Emergency Room and Physician Office. No prior vaccinations (within 4 weeks). The outcome of the event headache and sore throat was recovering; event tightening and slight swelling of the tongue/swelling of throat was recovered/resolved with sequel on 23Jan2021; and unknown outcome for the other events.  Information on the lot/ batch number has been requested.