chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: hearing sounds in his ear that sound "like water falling"; This is a spontaneous report from a contactable consumer or other non hcp. A 78-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration on 16Feb2021 (at the age of: 78-years-old) as dose 2, single for COVID-19 immunization. Medical history included earaches (needing eardrops for wax build-up), COVID-19 from Mar2020 to an unknown date, pneumonia. It was reported that that the patient had COVID back in 2020 and COVID pneumonia he had cleared his self of that but when it came time for him to go to take his semi annual physical, he saw his doctor and he complained of having ear aches and she recommend some ear drops and he put it in and it worked a little bit. There were no concomitant medications. The patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EK4176), via an unspecified route of administration on 27Jan2021 (at the age of 78-years-old) as dose 1, single for covid-19 immunization. On an unspecified date, the patient experienced hearing sounds in his ear that sound "like water falling". It was reported that the patient got the second dose and everything was going okay then last week he got in the bed and all of a sudden he started feeling little tingling in his ears. He wondered this could be something that the organization had received as a complaint of ear effects or if he might have a cold in his ear or water in his ear but he hears tingling right now. He just thought it may have been coming from the radiator then it was just in his head and still ongoing. It has stayed about the same, sometimes it will be a little lower and he will think it is going away then it comes back. It sounds like water falling. He does not report any headache, fever, chills, or anything. His medical history includes problems with earaches, needing eardrops for wax build-up, and he also had Covid19 back in Mar2020. He stated may be the antibodies are acting up and causing problems. He did have a problem with his ears. No further information provided. But lately last week he does not know whether he has a cold, they have had a lot of cold weather or if he had water in it or if it is a problem with the side effect. He had not had any other side effect, no swelling or nothing so he wanted to see if they had heard any other complaints or reports about this. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Described as a "minor thing" and pointed at arm; This is a spontaneous report from a contactable consumer or other non hcp. A male 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 an unspecified date as DOSE UNKNOWN, SINGLE for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient described as a minor thing and pointed at arm on an unspecified date. The event outcome was reported as recovered.    No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Influenza like illness, Overdose, Pain
Clinical narrative: typical soreness; flu like symptoms; weak; tired; he administered the Pfizer-BioNTech COVID-19 Vaccine second dose to 3 Patients but he has drawn more than the required volume (0.5mL instead of 0.3mL).; This is a spontaneous report from a contactable pharmacist. This Pharmacist reported similar events for 3 patients. This report is for 1st of 3 patients. A 30-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EL3302; Expiration Date: 28May2021), via an unspecified route of administration on 26Feb2021 as DOSE 2, 0.5 ML SINGLE, on 05Feb2021 (Batch/Lot Number: EL3302; Expiration Date: 28Mar2021) as DOSE 1, SINGLE for covid-19 immunisation. No prior vaccination within 4 weeks. The patient medical history was not reported. There were no concomitant medications. On 26Feb2021 the patient experienced he administered the pfizer-biontech covid-19 vaccine second dose to 3 patients but he has drawn more than the required volume (0.5ml instead of 0.3ml), weak, tired, on an unspecified date typical soreness, flu like symptoms. On an unknown date in 2021 the outcome of other events were recovered. The outcome of he administered the pfizer-biontech covid-19 vaccine second dose to 3 patients but he has drawn more than the required volume (0.5ml instead of 0.3ml) was unknown.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021223835 Same reporter/drug/event, different patient.;US-PFIZER INC-2021223836 Same reporter/drug/event, different patient.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Chills; Headaches; Very tiredness; Body aches; This is a spontaneous report from a contactable consumer (patient).  A 25-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration, administered in left arm on 25Feb2021 (Lot Number: EL3247, at the age of 25-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), via an unspecified route of administration on 05Feb2021 (Lot Number was not reported, at the age of 25-year-old) as dose 1, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. On 25Feb2021 at 22:00 (after about 10 hours following vaccination), the patient had experienced chills, headaches, very tiredness and body aches. The patient did not receive any treatment for the events. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. The outcome of the events tiredness and body aches was recovered on the morning of 27Feb2021, and the other events was recovered on an unspecified date.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Lymphadenopathy
Clinical narrative: This is a spontaneous report from a contactable other-HCP (patient). A 55-year-old male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, batch/lot# EN6202), at the age 55, via an unspecified route of administration, in left arm, on Feb 25, 2021, single dose, for COVID-19 immunization. The patient's medical history not reported. Historical vaccine included received the first dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# EL9262), at the age 55, via an unspecified route of administration, in left arm, on Jan 27, 2021, at 08:30, single dose, for COVID-19 immunization. The patient has no known allergies. The patient did not received any other vaccines within 4 weeks. Reportedly, patient took other medications in two weeks of vaccination. Prior to the vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19. On Feb 26, 2021, patient developed tender and swollen lymph nodes in left arm pit, fatigue and slight dizziness. The patient did not received any treatment for the events. The outcome of events: recovering. Follow-up attempts completed. No further information expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash
Clinical narrative: 8 days after vaccine, woke up and injection site was bright red and the size of a dime. Area was incredibly itchy and there was about a 5 inch rash around the injection site; 8 days after vaccine, woke up and injection site was bright red and the size of a dime. Area was incredibly itchy and there was about a 5 inch rash around the injection site; 8 days after vaccine, woke up and injection site was bright red and the size of a dime. Area was incredibly itchy and there was about a 5 inch rash around the injection site; This is a spontaneous report from a contactable other healthcare professional (Patient).   A 33-Year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH m-RNA COVID-19 VACCINE, formulation: Solution for injection, Lot number and expiry date was not reported), via Intramuscular route into left arm on 22Jan2021 at 02:15 pm as dose 1, single (Age at vaccination: 33-year-old) for Covid-19 immunization. Medical history included: Poly cystic ovarian syndrome. The patient had no Known allergies. The patient had not received any other vaccine within 4 weeks. The patient was not pregnant at the time of vaccination. The patient neither had covid prior vaccination and nor tested for covid post vaccination. Concomitant medications in two weeks included: semaglutide (OZEMPIC), spironolactone, ergocalciferol (VIT D) and birth control medicine (unspecified). On 30Jan2021 at 08:00 AM (8 days after vaccine), the patient woke up and injection site was bright red and the size of a dime. Area was incredibly itchy and there was about a 5-inch rash around the injection site. The patient did not receive any treatment for adverse events. Outcome of events was recovered on an unspecified date.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Vaccination site pain
Clinical narrative: he hadn't informed the vaccination provider about being on Xarelto; had soreness on the injection site/he had soreness on the injection site that lasted for a day after getting the vaccine; This is a spontaneous report from a contactable consumer (patient). A 64-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: not reported) via an unspecified route of administration on 26Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication included rivaroxaban (XARELTO). The patient explained when reading the fact sheet after vaccination, he got concerned when he realized he had not informed the vaccination provider about being on Xarelto on an unspecified date. The patient added the vaccination provider did not ask him about allergies or his medical conditions. He asked why you should you tell the vaccination provider about all of your medical conditions, including if you have a bleeding disorder or on a blood thinner. He also asked if the combination of the two, the Xarelto and the COVID-19 vaccine can cause him to have side effects; and if so, which ones should he look at for. The patient had no bruising or bleeding after vaccination. He also reported that he had soreness on the injection site that lasted for a day after getting the vaccine. The sore was already little and not painful on an unspecified date in Feb2021. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. The lot number for BNT162B2, was not provided and will be requested during follow up.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: Approx. 12 hours after 2nd dose of vaccine, woke up with chills that lasted-3 hours.; Rest of the day only symptoms were fatigue and aches; Rest of the day only symptoms were fatigue and aches; This is a spontaneous report from a contactable consumer. A 23-year-old female patient received second dose of BNT162B2 (Pfizer COVID 19 Formulation: Solution for Injection Batch/Lot Number: EL3247 Expiration Date: Unknown) via an unspecified route of administration, administered in Arm Left on 25Feb2021 11:00 (at the age of 23-year-old) as single dose for COVID-19 immunization. Patient previously received first dose of Pfizer COVID 19 vaccine (lot number: EL3247) on 04Feb2021 11:00 administered in left arm. The patients medical history and concomitant medications were not reported. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received Birth Control medication within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19 and Since the vaccination patient has not been tested for COVID-19. On 26Feb2021 12:00 Approx. 12 hours after 2nd dose of vaccine, patient woke up with chills that lasted for approximately 3 hours. No temperature was taken. Rest of the day only symptoms were fatigue and aches. Outcome of all the event chills was recovered on 26Feb2021 15:00 and rest all events was recovered on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain in extremity
Clinical narrative: sore arm; she's feeling nauseous (slightly queasy, come and go); This is a spontaneous report from a contactable consumer (patient). A female patient of an unknown age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number and expiry date: unknown) via unspecified route of administration on 19Feb2021 as DOSE 2, SINGLE for COVID-19. The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, batch/lot number and expiry date: unknown) via unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19. It was reported that the patient clarified she had her second shot on 19Feb2021 and this morning (01Mar2021) she was feeling slightly nauseated. She suspects it was not connected. Caller asks the call handler as a nurse in her professional opinion, could it be related to the vaccine this long after. The caller states the only reaction she had to the vaccine was a sore arm. 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: Inappropriate schedule of product administration, Tendonitis
Clinical narrative: tendonitis; received BNT162B2 first dose on 03Jan2021 and second dose on 21Feb2021; This is a spontaneous report from a contactable consumer (Patient). A female patient of unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EN6202) via an unspecified route of administration on 21Feb2021 as dose 2, single for COVID-19 immunization. Medical history included allergy from an unspecified date and unknown if ongoing. Concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: EL3249) via an unspecified route of administration on 03Jan2021 as dose 1, single for COVID-19 immunization and steroid shots (Lot number: unknown) via an unspecified route of administration on an unspecified date as dose number unknown, single for flare ups. It was reported that on an unspecified date patient experienced tendonitis. Patient wanted to know when she can have the steroid for her tendonitis in her hands. She also added that she is going to have steroids put into the hands, the lady also told her she cant have her allergy shots. She would get the steroid shots before the covid vaccine, when she would have flare ups, she gets it a couple times a year. She also has been getting the Allergy shots for about 30 years now she has not had an allergy shot in 5 weeks. Reporter also stated when getting the shot she was told that she should not get a mammogram and would have to wait for a month. The Mammogram was initially scheduled on 25Feb2021, and she rescheduled and couldn't get in till 19May2021.Reporter wanted to know when she schedules this appointment after having had the covid vaccine. RA was not present. Outcome of the event tendonitis was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Slight Soreness at Site of Injection; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 73-years-old female patient (patient was not pregnant at the time of vaccination) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6203, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 24Feb2021 at 10:30 am (age at vaccination was 73 years) as dose 1, single for COVID-19 immunization. The patient's medical history included 2 bowel obstruction surgeries and COVID-19 from an unknown date. Concomitant medications and other medications the patient received within 2 weeks of vaccination included multivitamins [vitamins NOS], ascorbic acid (VIT C), ergocalciferol, retinol (VITAMIN A & D [ERGOCALCIFEROL; RETINOL]) and zinc all taken for an unspecified indication. The patient previously took eritrovis [erythromycin] and experienced allergies to it. The facility where the most recent COVID-19 vaccine was administered was Public Health Clinic. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 24Feb2021 at 17:00 pm, the patient experienced slight soreness at site of injection. No treatment was received for the adverse event. 2 weeks from dose 1 date there were no side effects to report. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EP7534, Expiration date: unknown) via an unspecified route of administration, administered in left arm on 17Mar2021 at 10:15 am (age at vaccination was 73 years) as dose 2, single for COVID-19 immunization. The outcome of the event was resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Vaccination site pain
Clinical narrative: arm was sore; Headache; Lightheadedness; Fatigue; This is a spontaneous report from a contactable consumer (patient herself). A 70-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number: EN6202; Expiration date: unknown) via an unspecified route of administration on 23Feb2021 (at the age of 70-years-old) as DOSE 2, SINGLE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient had previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, lot number and expiration date was not reported) via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization. It was reported that patient received her second shot of the Pfizer BioNTech COVID-19 vaccine last week and on the way to the vaccination appointment, she reported she took one Tylenol. She stated it was then about a half hour later that she received her vaccine and would like to know if this affected her vaccine in any way. Caller did report after her second shot on an unspecified date her arm was sore "for maybe an hour" and then went away. She received 2nd dose of vaccine. Was stuck in traffic and got a headache so she popped an Tylenol not thinking about vaccine. So when she got shot, arm was little sore in the beginning like when she was walking back to her car and then it went away. She didn't have any symptoms other than lightheadedness and little fatigue. She was so scared that she knocked out the second shot with that one Tylenol. She was thinking as - What did I do? Did I ruin the second shot by taking that Tylenol? I get that some time, I feel protected. Therapeutic measures were taken as a result of headache as patient took Tylenol. The outcome of arm was sore was resolved on an unspecified date while it was unknown for all other events.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021580889 same patient/drug, different dose/event.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Movement disorder, Tremor
Clinical narrative: He is now not able to move the arm; Lightheaded episodes; Severe shakes; This is a spontaneous report from a contactable consumer. This consumer reported for a male patient (Husband) of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration, administered in unspecified Arm on 01Mar2021 as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine include dose 1 bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number was not reported, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. On an unspecified date of 2021 it was reported that patient was not able to move the arm he got the injection in without being in severe pain, having lightheaded episodes where patient has to sit down and severe shakes. The case was assessed as non serious. The outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Pain in extremity, Vaccination site pain
Clinical narrative: injection site pain; arm pain; headache; fatigue; her glands on the left side of throat are swollen; This is a spontaneous report from a contactable consumer. This 54-year-old female consumer (Patient) reported that:  A 54-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID -19 VACCINE, solution for injection, Lot Number: not reported, Expiry date: unknown) via an unspecified route of administration, on 12Feb2021 (54-years-old at the time of vaccination) as dose 1, single for COVID-19 immunization. Medical history included tonsil issues from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. On an unspecified date in Feb2021, the patient experienced injection site pain, arm pain, headache, fatigue and her glands on the left side of throat are swollen. Patient stated that received first dose of Pfizer Covid vaccine 12Feb2021. It was reported that the patient experienced injection site pain, arm pain, headache, and fatigue within the first 24 hours of receiving the vaccine. On an unspecified date on 2021, a week later, she started to experience left neck sided lymph node gland swelling which has continued for 2 weeks. She has an appointment with her ENT MD soon to discuss further. She is due to receive her second dose this Friday 05Mar2021. She wants to know if there is any information on this side effect. After 1st dose, her glands on the left side of throat are swollen and she is wondering if she should take 2nd dose. The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: dizziness; arm pain; This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: FL9261), via an unspecified route of administration, administered in Arm Right on 26Jan2021 (at the age of 84-year-old) as single dose for COVID-19 immunization. Medical history included flu (The patient went to (place) for winter. Last year when they both got home, they were really sick. Both patient and her husband, had to go to the Emergency room. Were sick for 3-4 weeks. Believes they had the COVID virus. Can't say for sure if it was COVID but was told they both had the Flu. Patient mentioned this to the doctor and some say she and her husband might have had the COVID virus. Confirmed this was a year ago, prior to receiving the COVID vaccines). Concomitant medication included heart pills and a blood pressure pill (unspecified). She takes two pills a day. The patient did not receive additional vaccines on same date of Pfizer suspect. The patient did not receive prior vaccinations within 4 weeks and had no AEs follow prior vaccinations. The patient had no family medical history. The patient received first dose of the Pfizer Covid vaccine on 26Jan2021. She experienced dizziness after the first dose and arm pain. The patient had no relevant tests. Outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Myalgia, Pain, Pain in extremity
Clinical narrative: all over sore/like all over my body; my lower back pain; my leg, my thigh pain; muscle pain; my arm pain; This is a spontaneous report from a contactable consumer (Patient). A 74-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EM9809), dose 1 intramuscular, administered in Arm Right on 12Feb2021 17:00 (age at vaccination 74-year-old) as dose 1, single for covid-19 immunization. The patients medical history and concomitant medications were none. On an unspecified date, the patient experienced all over sore, her arm, her lower back, her leg, her thigh pain, like all over her body and muscle pain and ache in back. The patient was tried exercising and it does not go away. This was patient first dose and she was getting her second dose on Friday (unspecified date). The patient assessed the events as non-serious. No adverse event following prior vaccinations. The outcome of the events was not recovered.  No follow up attempts are needed. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph nodes were swollen/she has swollen lymph nodes under her arm and in her groin; This is a spontaneous report from a contactable consumer. A 53-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE: Solution for injection; Batch/Lot Number: EM9809; Expiration Date: Jun2021), dose 1 via an unspecified route of administration, administered in Arm Right on 11Feb2021 18:30 as dose 1, single for covid-19 immunisation (at the age of 53-year-old). Medical history included was none. The patient's concomitant medications were not reported. Caller states that she called earlier and spoke to someone about her Pfizer BioNTech COVID-19 vaccination and a side effect that she is experiencing. Caller states that she received her first dose and the very next day noticed her lymph nodes were swollen. Caller states that she did read that swollen lymph nodes is one of the side effects. She is due to receive her second dose on Thursday and states that it has gotten better but still a little swollen. Caller would like to know if she should expect this to get any worse. The caller said that right after her vaccination, she noticed swollen lymph nodes. She said that it is a listed side effect on the paperwork that she received. It is contraindicated for her to get the second dose with still having swollen lymph nodes. The caller said that she has swollen lymph nodes under her arm and in her groin the day after the vaccination. She said that she noticed more swollen lymph nodes on the left side of her body. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event was recovering.  No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 30-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EP6955), via an unspecified route of administration, administered in Arm Right on 23Mar2021 11:45 (at the age of 30-year-old) as dose 2, single and received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3247) via an unspecified route of administration, administered in left arm on 01Mar2021 10:30 (at the age of 30-year-old) as dose 1, single for COVID-19 immunization at Workplace clinic. The patient medical history was not reported. Patient had no allergies. Concomitant medication(s) within 2 weeks included ethinylestradiol, norgestimate (NORGESTIMATE AND ETHINYL ESTRADIOL). The patient was not pregnant at time of vaccination. The patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. On 01Mar2021 13:00 The patient experienced injection site pain. The patient had injection site pain approximately 2-3 hours after vaccine. Patient did not received any treatment for the event. The outcome of the event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 80.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain
Clinical narrative: feeling achy; This is a spontaneous report received from a contactable consumer reporting for a patient. An 80-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: unknown), via an unspecified route of administration on 26Feb2021 14:00 at the age of 80-years-old as dose 1, single for covid-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history and concomitant medications were not reported. It was unknown if the patient received any other vaccines within 4 weeks prior to the COVID vaccine. It was unknown if the patient was diagnosed with COVID-19 prior to vaccination. It was unknown if the patient has been tested for COVID-19 since the vaccination. On 27Feb2021, the patient experienced feeling achy, a day after receiving her first Pfizer Covid19 vaccine shot. It was unknown if the patient received treatment for adverse event. Adverse event resulted in none of the above. The outcome of event was recovered on an unspecified date in 2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: She had mild side effects to the first vaccine; This is a spontaneous case received from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of age 90 (units unspecified) received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported), via an unspecified route of administration, administered on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration, administered on an unspecified date for Covid-19 immunization. On an unspecified date, the patient reported that she had mild side effects to the first vaccine. The outcome of the event was unknown.  No follow-up attempts are needed, information about lot/batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: injection site being a little sore; This is a spontaneous report from a contactable consumer (patient). A 73-years-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6198, Expiration date: 30Jun2021), via an unspecified route on 28Feb2021 (at the age of 73-years) as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN5318, Expiration date: May2021), via an unspecified route on unspecified date as dose 1, single for covid-19 immunisation. The patient experienced injection site being a little sore on unspecified date. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Fatigue; This is a spontaneous report from a Pfizer sponsored program . A contactable 63-years-old male consumer (patient) reported to received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. It was reported that first dose about 3 weeks ago, second dose due to 03Mar2021. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm, fatigue. Patient requested information regarding antibodies testing or T-cells tests to assess for immunity/effectiveness after vaccination. Patient asked if he use antipyretics before or after vaccination with the Pfizer-BioNTech COVID-19 vaccine. The outcomes of events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site discomfort
Clinical narrative: sore arm; wondering if you have discomfort in the injection site after the first dose, and no; This is a spontaneous report from a contactable physician (patient). A 54-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously took Shingrix and experienced sore arm. The patient received both doses of Pfizer's COVID vaccine 22 days apart. The reporter stated that she had a mild response to the first vaccine with a sore arm, but had no fever nor headache and for her second dose, she had no symptoms whatsoever. Caller asked what statistics do you have in having less adverse reactions of the second dose compared to the first dose, How likely is it that a vaccine recipient would have injection site soreness after dose 1, but no symptoms/no reaction after dose 2. Would there be any concern that the second dose had been mishandled and this was ineffective. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Hypotonia, Motor dysfunction, Walking aid user
Clinical narrative: she uses a walker all the time now; She said that her legs were floppy; she lost the use of her legs; This is a spontaneous report from a contactable consumer (patient). A 86-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EL3248), via an unspecified route of administration, administered in arm right on 11Feb2021 (at the age of 86-years) as dose 2, single for covid-19 immunization. Patient had no relevant medical history. The patient concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch number: EL0140) at the age of 86-years, dose 1, on 28Dec2020 in right arm for covid-19 immunization. The patient got first vaccine 28Dec2020 and then got the second vaccine on 11Feb2021 on a Thursday, states the next day 12Feb2021, the patient had no use of legs, they were flopping all over. The patient wants to know why this happened, the patient was wondering why did her legs go bopping around, states it improved a couple of days later but the patient uses a walker all the time now. The outcome of had no use of her legs was recovering and outcome of other events was unknown.   No follow up attempts are needed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Limb discomfort, Pain in extremity
Clinical narrative: she has an inflammatory/rheumatologic disease and she had a flare just this week/relapsing polychondritis flare; sore right arm; Arm discomfort; This is a spontaneous report from a contactable consumer(patient). A 59-year-old female had received bnt162b2 (Pfizer-biontech covid-19 vaccine, Solution for injection, Batch/lot number: EM9809) via an unspecified route of administration into arm right on 13Feb2021 08:30 (age at vaccination 58 Years) as DOSE 1, SINGLE for covid-19 immunization. The patient medical history was Relapsing polychondritis, (she was diagnosed with about 7 years ago. she has an inflammatory/rheumatologic disease). Concomitant medications:None. The patient was reported that she was diagnosed with polychondritis about 7 years ago and clarified about 1 in 1,000,000 people are diagnosed with the disease . It was reported that patient did not take any vaccine within 4 weeks prior to vaccination. On Feb2021the patient had experienced she had a sore right arm for several days after receiving her first dose of the COVID-19 Vaccine, arm discomfort and an inflammatory/rheumatologic disease and she had a flare just this week/relapsing polychondritis flare because of that, she decided that she is no longer going to get the 2nd dose this weekend(06Mar2021). She wants to know the efficacy rate of the vaccine with just 1 dose. Therapeutic measures were taken for the AE inflammatory/rheumatologic disease and she had a flare just this week/relapsing polychondritis flare and treatment was given with Colchicine 0.6mg 1 to 2 times daily and was taking Ibuprofen 400mg daily.She said her doctor was considering putting her on other medication because the Colchicine 0.6mg doesn't work as good as it used to. The clinical outcome of the events inflammatory/rheumatologic disease and she had a flare just this week/relapsing polychondritis flare was not recovered and sore right arm, arm discomfort was recovered on Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dizziness, Nausea, Off label use, Palpitations
Clinical narrative: heart palpitations; chills; nauseous; dizzy; previous steroids shot was given on 20Feb2021; previous steroids shot was given on 20Feb2021; This is a spontaneous report from a contactable nurse. A 82-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EP7534, Expiry date: unknown) (age at the time of vaccination was 82 years), administered in Arm Left on 24Feb2021 at 12:57 as dose 2, single for COVID-19 immunization. The patient's medical history included neck problem received 6 or 7 cortisone injections, for a nerve rubbing a bone, heart palpitations. Historical vaccine included shingles vaccine had a slight reaction to the shingles vaccine that took last summer. The patient's concomitant medication was not reported. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3249), administered in Arm Left on 20Jan2021 at 12:40 as dose 1, single for COVID-19 immunization. The patient had sore arm/numb arm while taking first dose. The patient was really happy, but had some side effects. On 20Feb2021, the patient received steroids shot given in between vaccine doses. The patient had chills after getting second dose of the vaccine. The patient was fairly dizzy and kind of nauseous the first night. The patient know that chills were part of the Covid-19 vaccine, but wants to know how long would expect to have the chills before it goes away. Where patient first came home he was very excited and also had heart palpitations. The patient had heart palpitations before vaccine also. Got through the night alright. The patient was concerned about it. Once patient get under covers he was ok. Thought the chills would gradually go away would be less each day. The outcome of the events was unknown.  No follow-up attempts were possible. No further information was expected.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Product use issue
Clinical narrative: heart palpitations; chills; nauseous; dizzy; previous steroids shot was given on 20Feb2021; previous steroids shot was given on 20Feb2021; This is a spontaneous report from a contactable nurse. A 82-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, lot number: EP7534, Expiry date: unknown) (age at the time of vaccination was 82 years), administered in Arm Left on 24Feb2021 at 12:57 as dose 2, single for COVID-19 immunization. The patient's medical history included neck problem received 6 or 7 cortisone injections, for a nerve rubbing a bone, heart palpitations. Historical vaccine included shingles vaccine had a slight reaction to the shingles vaccine that took last summer. The patient's concomitant medication was not reported. The patient did not take any other vaccine in four weeks prior COVID -19 vaccine. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot Number: EL3249), administered in Arm Left on 20Jan2021 at 12:40 as dose 1, single for COVID-19 immunization. The patient had sore arm/numb arm while taking first dose. The patient was really happy, but had some side effects. On 20Feb2021, the patient received steroids shot given in between vaccine doses. The patient had chills after getting second dose of the vaccine. The patient was fairly dizzy and kind of nauseous the first night. The patient know that chills were part of the Covid-19 vaccine, but wants to know how long would expect to have the chills before it goes away. Where patient first came home he was very excited and also had heart palpitations. The patient had heart palpitations before vaccine also. Got through the night alright. The patient was concerned about it. Once patient get under covers he was ok. Thought the chills would gradually go away would be less each day. The outcome of the events was unknown.  No follow-up attempts were possible. No further information was expected.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diarrhea; This is a spontaneous report from a contactable consumer. This 35-year-old Male consumer (Patient) reported that who received bnt162b2 (BNT162B2) solution for injection, dose 1 (Batch/Lot Number: EN6203) via an unspecified route of administration, administered in arm left on 28Feb2021 09:30 (at the age of 35-years-old) as dose 1 single for covid-19 immunisation. Medical history included from an unknown date and unknown if ongoing other_medical_history: No. Concomitant medication(s) included amoxicillin (AMOXICILLIN) taken for an unspecified indication, start and stop date were not reported. Prior to the vaccination the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. Patient did not have known allergies. No treatment was received for the adverse events. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. On 01Mar2021 09:00 the patient experienced diarrhoea. Outcome of the event was recovered on an unspecified date.    Follow-up (12MAY2021): Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: sore arm/muscle; sore arm/muscle; This is a spontaneous report from a contactable consumer (patient). A male patient (Age 73; units: Unspecified) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution of injection, Lot Number was not reported) via an unspecified route of administration on an unspecified date as dose 1, single for COVID-19 immunization. The patient medical history and the concomitant medications were not reported. On an unspecified date the patient experienced sore arm/muscle. The reporter reported that 3 and 1/2 weeks ago the patient took the first shot, everything went good and it felt like it was kicking in and it went well. The patient didn't have any allergy or reactions. The patient had a sore arm/muscle for a little while and then felt good. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 71-year-old female received the second dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# not reported, expiration date: unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization. The patient's medical history and concomitant medications not reported. The patient previously received the first dose of BNT162B2 (Comirnaty, solution for injection, batch/lot# not reported, expiration date: unknown), via an unspecified route of administration, on an unspecified date, single dose, for COVID-19 immunization and had a headache. On an unspecified date, patient had fatigue; with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: he wasn't feeling really well; chills; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: not reported), via an unspecified route of administration on 15Feb2021 as dose number unknown, single for covid-19 immunization. Medical history included the patient has a pacemaker. The patient concomitant medications were not reported. The patient reported that he got the shot first shot 15Feb2021. He confirms the Pfizer COVID 19 vaccine. He felt good for quite a while then he started getting chills. He may have had some chills before but he was supposed to go up this morning to the drug store and have them run a test to see if had the COVID or if he does not have it. He asked would that test tell him if had the COVID or if this was a reaction from the shot. He has not had fever, he was not sure if he had chills before the vaccine or after but about week after had the vaccine, maybe a little less, he was not feeling really well, he just does not feel up to par. It just so happens he has a pacemaker and he was going to see his doctor for a check up on Thursday of this week and he told them he was not feeling well and they said okay they told him they were going to have him go into the pharmacy this morning and have them run a test to see if he has the COVID virus. He said his main concern was he was going in week from next Monday for the second shot. He asked was there any chance that they will tell him not to get the second shot because he would be due to have the other shot so if he gets that he wanted to know if he would have the same reactions or little bit less. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained. No further information is expected.