chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling hot, Pruritus, Rash
Clinical narrative: Body rash appears after 33hours; feels very hot; itchy; This is a spontaneous report from a contactable consumer, the patient. This 58 year old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number: EN9581), dose 1, single dose, via an unspecified route of administration in the left arm on  08FEB-2021 at 10:45 (at the age of 58 years-old) for COVID-19 vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. There was no relevant medical history reported. Historical vaccine  included flu shot on 18Jan2021. Concomitant medications included calcium sulfate dihydrate, dryoptieris crassirhizoma rhizome, ephedra Spp, herb, forsythia suspensa, glycyrrhza glabra root, houttuynia cordata herb, isatis tinctorial root, lonicera Japonica flower, menthol, pogostemom cablin herb, prunius SPP, seed, rheum SPP, rhodiola crenulate (LIAN HUA QING WEN) capsules.  On 10Feb2021 at 15:00, the patient experienced body rash after 33 hours, was itchy and very hot. No treatment was received for body rash, itchy and very hot. The clinical outcome of body rash, itchy and very hot was not recovered. 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: Arthralgia, Joint swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Painful and swollen left knee; Painful and swollen left knee; Painful and swollen thigh after 24 hours after vaccination.; In left arm pain; little swollen in 5 hours after; This is a spontaneous report from a contactable consumer or other non hcp. A 72-year-old female patient received bnt162b2 (BNT162B2, solution for injection, Lot #: EN6201), dose 1 via an unspecified route of administration, administered in Arm Left on 12Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. On 12Feb2021, the patient experienced in left arm pain, little swollen in 5 hours after, On 13Feb2021, the patient experienced painful and swollen left knee, painful and swollen thigh after 24 hours after vaccination. The action taken in response to the event for bnt162b2 was not applicable. Therapeutic measures were taken as a result of in left arm pain (pain in extremity), little swollen in 5 hours after (peripheral swelling), painful and swollen left knee (arthralgia), painful and swollen left knee (joint swelling), painful and swollen thigh after 24 hours after vaccination. (pain in extremity). The outcome of the event was not recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Nausea, Pyrexia, Rash erythematous, Vaccination site erythema
Clinical narrative: nausea; low grade fever; chills; 4hrs after shot: redness at injection site; red rash about 3" in diameter on non vaccinated arm. Rash is not itchy or raised; This is a spontaneous report from a contactable consumer (patient). A 70-year-old female received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EL9264), via an unknown route of administration on 11Feb2021 at 16:00 (04:00 PM) in Left arm at single dose for COVID-19 immunisation at Pharmacy or Drug Store. Age at vaccination was 70 years. The patient wasn't pregnant at the time of vaccination. Patient had allergies to medications, food, or other products. Other medical history included asthma. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications the patient received within 2 weeks of vaccination included fluticasone propionate, salmeterol xinafoate (ADVAIR) at 250/50; lisinopril (LISINOPRIL) at 40 mg dose; salbutamol sulfate (VENTOLIN) Inhaler. The patient experienced redness at injection site 4hrs (at 20:00) after shot on 11Feb2021. On 12Feb2021 at 18:00 (06:00 PM), she experienced nausea, low grade fever, chills 24hrs after shot; on Feb2021 experienced red rash about 3" in diameter on non vaccinated arm 40hrs after shot. Rash was not itchy or raised. Patient didn't received treatment for the adverse event. Prior to vaccination, the patient wasn't diagnosed with COVID-19. Since the vaccination, the patient hasn't been tested for COVID-19. Serious was reported as no. Outcome of all events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous
Clinical narrative: Red rash under left breast and down side; This is a spontaneous report from a contactable consumer, the patient. A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, Lot EN9581, first dose) solution for injection intramuscular in the left arm on 02Feb2021 at 15:00 (at the age of 76-years-old) as a single dose for COVID-19 vaccination. The patient was not pregnant at the time of vaccination. Medical history included high blood pressure. Concomitant medications were not reported. Past drug history included known allergies: amoxicillin. The patient did not receive any other vaccine within 4 weeks prior to the vaccine. Prior to the vaccination, the patient was not diagnosed with COVID-19. On 02Feb2021, the patient experienced red rash under left breast and down side. No treatment was provided for the event red rash. The outcome of the event red rash was not recovered. Since the vaccination, the patient has not been tested for COVID-19.
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Pulmonary pain, Vaccination site pain
Clinical narrative: Experiencing chest/lung pain. Indicates injection site soreness.; Experiencing chest/lung pain. Indicates injection site soreness.; Experiencing chest/lung pain. Indicates injection site soreness.; This is a spontaneous report from a contactable health care professional .   A 49 year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Feb2021 (Batch/Lot number was not reported) at 11:00 as a single dose for covid-19 immunisation  .  Medical history and concomitant medications were not reported.  The patient received  the vaccine and was experiencing chest/lung pain. Indicates injection site soreness. Questions about Tylenol/Advil. The outcome of the events was not reported.  Information on the lot/batch number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site induration, Vaccination site warmth
Clinical narrative: very warm right arm with a 3D red area; very warm right arm with a 3D red area; very warm right arm with a 3D red area; This is a spontaneous report from a contactable nurse reporting for herself. A 83-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL9269/expiration date: not provided), via an unspecified route of administration, on 05Feb2021 at 15:00 (at the age of 83 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. Relevant medical history and concomitant medication were not provided. The patient had a known allergy to codeine and scopolamine. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number EL128401003592671000 231721043010EL1/expiration date: not provided), via an unspecified route of administration, on 15Jan2021 at 15:00 (at the age of 83 years old) as a single dose in the right arm for COVID-19 IMMUNIZATION. The patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 09Feb2021 at 19:00, the patient experienced very warm R arm with a 3 D red area. The patient had no pain, and no fever. The very warm R arm with a 3 D red area was gone in the morning but reappeared around 7pm the next 4 days with the reddness decreasing each day. Each morning it was gone but reappeared each evening from day 5 to day 10. The event did not require a physician office, emergency room visit or hospitalization. The patient did not receive any treatment for these events. The outcome of the event very warm R arm with a 3 D red area was recovered on an unspecified date in Feb2021. Since the vaccination, the patient had not been tested for COVID-19.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: suspected COVID-19; suspected COVID-19; This is a spontaneous report from a non-contactable consumer (patient's daughter). An 80-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection) via an unspecified route of administration on 24Jan2021 as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. It was reported that the patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine on 24Jan2021 and had contracted COVID-19. The reporter stated that the patient was supposed to receive the second dose "today"; however, since the patient contracted COVID-19 she was unable to get her second dose. The reporter wanted to know if the vaccine would still be effective if the patient waited until after she had recovered before receiving the second dose. The reporter wanted to know exactly how many days after the patient recovered from COVID-19 should she receive the second dose of the vaccine. The patient also stated that her sister suggested that their mother receive an antibody infusion and wanted to know if this would affect the Pfizer-BioNTech Covid-19 Vaccine. The clinical outcome of the event "suspected COVID-19" was unknown.    No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: positive COVID-19 test with symptoms; This is a spontaneous report from a contactable nurse (patient). A 57-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; Lot number: EL9263) via an unspecified route of administration on 03Feb2021 (at the age of 57-years-old) as a single dose for COVID-19 immunisation. Medical history and concomitant medications were not reported. The patient experienced "positive COVID-19 test with symptoms" on 11Feb2021. The clinical course was reported as follows: "On 30Jan2021 I had a negative COVID-19 test, which I got every week because my wife is terminally ill. On 03Feb2021 I had the first dose of the Pfizer vaccine with my wife as well. On 10Feb2021, 7 days later, I started to be symptomatic. On 11Feb2021, I did a lab test and on 12Feb2021 I did an instant test, both came back positive. Today, on 14Feb2021, I had a monoclonal antibody infusion (the product was Bamlanivimab monoclonal antibody infusion)." The patient was scheduled to receive the second dose of the COVID-19 vaccine on 23Feb2021 (also reported as 24Feb2021) and asked if he should receive the second dose or not. When probed if side effects were due to the COVID-19 vaccine, the patient stated, "No, there must have been a window from when I contracted it. It is just the timing was altogether. Really, the other reason I called was to check on the status for the secondary but in my opinion no" (as reported). The clinical outcome of the event "positive COVID-19 test with symptoms" was not recovered/not resolved.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Malaise, Pain in extremity
Clinical narrative: chills; sore arm; Did not feel well during the night; This is a spontaneous report from a non-contactable consumer (non-healthcare Professional reporting for a patient).   A 87-years-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number Unknown), via an unspecified route of administration, administered in Arm Left on 13Feb2021 at 13:15 (at the age of 87-years-old)  as a single doe  for covid-19 immunization  The patient medical history and concomitant medications were not reported. The patient has no known allergies.  No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. On 13Feb2021 The patient experienced chills,  sore arm and did not feel well. The clinical course is as follows the patient didn't feel good during the night and had chills during the night. Feels fine 24 hours later except for a sore arm. No treatment was given for the events. The clinical outcome of the event chills, and malaise were recovering while sore arm was not recovered.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: lymph nodes underneath the left armpit were swollen; This is a spontaneous report from a contactable other health professional (patient). A 41-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), dose 2 intramuscularly, administered in the left arm on 12Feb2021 at 08:45 (Batch/Lot Number: EL9261) at 41-years-old as a single dose for COVID-19 immunisation; administered in a hospital. The patient's medical history was reported as none; no known allergies. The patient did not have COVID prior to the vaccination. Concomitant medications were not reported. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE Lot number: EJ1686, Administration time:08:45, intramuscularly, Left arm, Dose number:1) for COVID-19 immunisation on 22Jan2021 at 41-years-old. On 13Feb2021 at 07:00, after the second dose, the patient experienced: lymph nodes underneath the left armpit were swollen (non-serious). There was no treatment provided. The clinical outcome of the event, Swollen lymph nodes, was not recovered. The patient was not tested for COVID post vaccination.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Dysgeusia, Headache
Clinical narrative: headache; Asthmatic Cough; Taste metallic/ tongue felt metallic; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 04Feb2021 11:40 (Batch/Lot Number: EL9261) (at 59-year-old) as single dose for COVID-19 immunization. Medical history included Hypertension, Gout, Allergy. She clarified that she is allergic to NSAIDS and as well has environmental and food allergies. She clarifies that her Allergies do change from time to time, she is allergic to fragrances. Wheat bothered her before, but not anymore, thats what she meant by her allergies changes. Concomitant medications was not reported. She did not take any NSAIDS because they made her wheeze. She only had her regular medication that she takes on routine schedule.  The patient previously took ibuprofen and allergy. She is Allergic to ibuprofen and had an asthmatic cough after it. The patient had first dose of the Pfizer covid vaccine a week ago Thursday, she has a question. She had that dose, and when she had the injection was fine, she did have a metallic taste in mouth (04Feb2021) but it was no issue. Then she woke up coughing on Friday (05Feb2021) and Saturday (06Feb2021), it was like an asthmatic feeling, she will feel it time to time when having an allergy to something. She had headache on Sunday (07Feb2021). She didnt know if that was an indication to a problem with the vaccine. She wanted to know if it was safe to take the second dose. It was clarified that the metallic taste started 10 minutes after the injections. The Asthmatic Cough started on Friday 05Feb2021, she woke up coughing. She clarified that the metallic taste only last just up to that afternoon. The asthmatic cough subsided Saturday. She experienced a lot of coughing on Friday, then a little on Saturday and that was last day. She was just concerned about it, she did not want it to get worse. She does not normally have metallic taste in her mouth, so she thought it could be related but she really doesn't know. She didn't know if the asthmatic cough is related, it could even be a coincidence, she hasn't experienced something like this in a year. She just wants to know if she should get the second dose. It stated that her second dose is schedule for 25Feb2021 at 11:40AM. The outcome of the event Taste metallic/ tongue felt metallic was recovered on 04Feb2021, Asthmatic Cough was recovered on 06Feb2021, and headache was unknown.
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Cough, Dysgeusia
Clinical narrative: headache; Asthmatic Cough; Taste metallic/ tongue felt metallic; This is a spontaneous report from a contactable nurse (patient). A 59-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), first dose via an unspecified route of administration, administered in Arm Left on 04Feb2021 11:40 (Batch/Lot Number: EL9261) (at 59-year-old) as single dose for COVID-19 immunization. Medical history included Hypertension, Gout, Allergy. She clarified that she is allergic to NSAIDS and as well has environmental and food allergies. She clarifies that her Allergies do change from time to time, she is allergic to fragrances. Wheat bothered her before, but not anymore, thats what she meant by her allergies changes. Concomitant medications was not reported. She did not take any NSAIDS because they made her wheeze. She only had her regular medication that she takes on routine schedule.  The patient previously took ibuprofen and allergy. She is Allergic to ibuprofen and had an asthmatic cough after it. The patient had first dose of the Pfizer covid vaccine a week ago Thursday, she has a question. She had that dose, and when she had the injection was fine, she did have a metallic taste in mouth (04Feb2021) but it was no issue. Then she woke up coughing on Friday (05Feb2021) and Saturday (06Feb2021), it was like an asthmatic feeling, she will feel it time to time when having an allergy to something. She had headache on Sunday (07Feb2021). She didnt know if that was an indication to a problem with the vaccine. She wanted to know if it was safe to take the second dose. It was clarified that the metallic taste started 10 minutes after the injections. The Asthmatic Cough started on Friday 05Feb2021, she woke up coughing. She clarified that the metallic taste only last just up to that afternoon. The asthmatic cough subsided Saturday. She experienced a lot of coughing on Friday, then a little on Saturday and that was last day. She was just concerned about it, she did not want it to get worse. She does not normally have metallic taste in her mouth, so she thought it could be related but she really doesn't know. She didn't know if the asthmatic cough is related, it could even be a coincidence, she hasn't experienced something like this in a year. She just wants to know if she should get the second dose. It stated that her second dose is schedule for 25Feb2021 at 11:40AM. The outcome of the event Taste metallic/ tongue felt metallic was recovered on 04Feb2021, Asthmatic Cough was recovered on 06Feb2021, and headache was unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature abnormal, Chills, Headache, Pain
Clinical narrative: severe headache; body pain/ aches; Chills; temperature; This is a spontaneous report from a contactable consumer (patient). A 67-year-old female patient received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3302; Expiration Date: May2021), via an unspecified route of administration, in Arm Left on 04Feb2021 around 09:00 AM as SINGLE DOSE for covid-19 immunization. The patient (age was 66-year-old) first dose was LOT: EK4176 with EXP Mar2021 and was injected 14Jan2021, in her left arm around 09:00AM for covid-19 immunization. She says she did have a flu shot in Sep (unspecified year, NDC/LOT/EXP unknown). Medical history included fibromyalgia from 2009, lyme disease and Arthritis from an unknown date; all unknown if ongoing (reported as diagnosis of fibromyalgia/Lyme disease depends on what specialist she sees, but she was diagnosed first with fibromyalgia in 2009. She says that she also has severe osteoarthritis, but not the one that does the bones, just put arthritis, since it is not the type that deteriorates the bones, it does cartilage). There were no concomitant medications. The patient says she has not had any other recent vaccinations or started any new medications. It was reported by the patient, who says she had her second vaccination on 04Feb2021 and had a pretty strong reaction for about 36 hours. She says she had a severe headache, body pain, and a temperature with no chest involvement. She says she has experienced this every 3 hours for days now after, in waves. She says she would like to know if anyone else has reported a similar thing as what is happening to her. She says she goes 3-4 hours with a headache and chills today, and aches, and she didn't know if that was typical or not. She says she has not spoken to her health care provider about this. The patient reported that she got the vaccines from pharmacists that came to the care center where her mother lives. For the treatment the patient says she took Ibuprofen last night, which seemed to give her some relief. She says that the Ibuprofen (EXP Jan2022, LOT: 63650291AA, UPC: 1387402032). She says that the Ibuprofen is 200mg and she just took one dose, one time only, she tried it yesterday. She says when it started and hit again today she thought she should call someone and talk about it. The outcome of the events was unknown.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: Chills; Fever; Pounding headache; Swollen lymph nodes on left side; This is a spontaneous report from a contactable consumer.   A 61-year-old female patient received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration, administered in Arm Left on 05Feb2021 09:45 AM (Batch/Lot Number: EL3247), at the age of 61-year-old at the time of vaccination, as SINGLE DOSE for covid-19 immunisation  .  Medical history included chronic lymphocytic leukaemia (CLL) and former breast cancer. Concomitant medication included tamoxifen 20 mg taken for an unspecified indication, start and stop date were not reported. The patient received dose 1 of vaccine on 15Jan2021 01:00 PM at left arm, lot number: EL1283. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, was the patient was not diagnosed with COVID-19. On 05Feb2021 22:00, the patient experienced chills, fever, pounding headache, swollen lymph nodes on left side. The outcome of the events was recovered. The patient took Tylenol as treatment for the events. Since the vaccination, the patient has not been tested for COVID-19.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: Drug hypersensitivity, Vaccination site rash
Clinical narrative: allergic reaction; he developed a rash on the arm in which the vaccine was received; This is a spontaneous report from a contactable consumer (patient's spouse). A 90-years-old male patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as a single dose, for covid-19 immunisation  .  Medical history and concomitant medications were not reported.  The wife stated that her husband is 90 years old and he experienced an allergic reaction after receiving the first dose of the Pfizer COVID-19 vaccine. She stated he developed a rash on the arm in which the vaccine was received, on part of his waist and below. His doctor has told him that he would be okay to receive the second dose of the vaccine. "The doctor I took him to put him on 50 mg Benadryl 3 times a day for 7 day, then they also put him on Prednisone. We did not think he had allergy but I am thinking that about 8 months ago I used the new laundry detergent."The outcome of the event was  not reported.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia
Clinical narrative: substantial hoarseness; This is a spontaneous report from a contactable physician reported that: A 73-years-old male patient received bnt162b2 (BNT162B2; PFIZER-BIONTECH COVID-19 VACCINE; solution for injection), via intramuscular on 29Jan2021 as single dose for covid-19 immunization. The patient's concomitant medications were unknown. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. Facility type Vaccine: Hospital. On 02Feb2021, patient experienced substantial hoarseness, but no other signs of allergy, no respiratory distress. Treatment received with Xyzal. Outcome of the event was not recovered.  Information on the lot/batch number has been requested.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Weight
Clinical narrative: Rash on torso/rash on bicep; This is a spontaneous report from a contactable consumer. A 70-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration in Arm Right on 02Feb2021 (Batch/Lot Number: EL9264) at single dose for covid-19 immunisation. Medical history included he contracted Covid in late Oct2020, blood clots from Nov2020 to an unknown date. Concomitant medication included apixaban (ELIQUIS) taken for blood clots from Nov2020 and ongoing. It was reported that patient received the first dose of Covid-19 vaccine 2 days ago. He has a red rash on each side of his torso and a little rash on his right bicep. This is the same type of rash he developed when he contracted Covid in late Oct2020. Typically, he has a rash when he gets a virus. Patient's weight was between 158-160lbs. The rash does not itch. He wouldn't know that he has it other than seeing it. Outcome of the event was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Antibody test negative, Blood immunoglobulin G, Blood immunoglobulin M, Drug ineffective
Clinical narrative: Antibody test came back negative; Antibody test came back negative; This is a spontaneous report from a contactable Physician. This Physician reported similar events for 2 different patients. This is 2 of second reports. A patient of an unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "caller, after asking if the agent was a physician, stated that he administered the Pfizer Covid vaccine to two patients approximately 5 weeks ago. However, their IgG/IgM antibody test came back negative, and wanted to know if these patients have developed immunity". Outcome of the events was unknown. No PQC present.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021116439 same reporter/drug, different patient
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenopia, Chills, Dizziness, Eye pruritus, Fatigue
Clinical narrative: Lightheadedness; tired; aches in her hands; corner of her eye and around it was itching really bad; started hurting and felt strained; started itching in her body; Headache; muscle aches; Nausea; Chills; This is spontaneous report from a 78-Year-old Female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9269), via an unspecified route of administration on 02Feb2021 at single dose for covid-19 immunization on arm left. The patient relevant medical history and concurrent conditions included cataracts from 2005 with ongoing, macular degeneration from 2012 with ongoing, arthritis from an unknown date and ongoing and fingers and both hands that had knots since 2010. The patient stated that she had nausea, chills, headache, and muscle aches on 02Feb2021, and on 03Feb2021, she had lightheadedness, tired, and aches in her hands where she has arthritis and all at once that the corner of her eye and around it was itching really bad and she touched it to relieve the itch and they started hurting and felt strained. The patient got Systane over the counter eye drops that she had and held hot compresses to it. She reported that it lasted for a few hours and she had cataracts and a little macular. The patient started itching in her body at 7:30 and took Benadryl and went to bed and it went away. She was concerned with second vaccine as she got through the nausea and everything else, but her eyes scared her. The patient received treatment medication for nausea and took Tylenol for Arthritis and muscle aches. The patient had an x-ray 3 years ago for her back and was diagnosed for unknown results. The outcome of the events nausea, aches in her hands, corner of her eye and around it was itching really bad, started hurting and felt strained and started itching in her body was resolved on 03feb2020, whereas the events chills, lightheadedness, tired, headache and muscle aches were resolved on 04Feb2021.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Nausea, Pain in extremity, Pruritus
Clinical narrative: Lightheadedness; tired; aches in her hands; corner of her eye and around it was itching really bad; started hurting and felt strained; started itching in her body; Headache; muscle aches; Nausea; Chills; This is spontaneous report from a 78-Year-old Female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9269), via an unspecified route of administration on 02Feb2021 at single dose for covid-19 immunization on arm left. The patient relevant medical history and concurrent conditions included cataracts from 2005 with ongoing, macular degeneration from 2012 with ongoing, arthritis from an unknown date and ongoing and fingers and both hands that had knots since 2010. The patient stated that she had nausea, chills, headache, and muscle aches on 02Feb2021, and on 03Feb2021, she had lightheadedness, tired, and aches in her hands where she has arthritis and all at once that the corner of her eye and around it was itching really bad and she touched it to relieve the itch and they started hurting and felt strained. The patient got Systane over the counter eye drops that she had and held hot compresses to it. She reported that it lasted for a few hours and she had cataracts and a little macular. The patient started itching in her body at 7:30 and took Benadryl and went to bed and it went away. She was concerned with second vaccine as she got through the nausea and everything else, but her eyes scared her. The patient received treatment medication for nausea and took Tylenol for Arthritis and muscle aches. The patient had an x-ray 3 years ago for her back and was diagnosed for unknown results. The outcome of the events nausea, aches in her hands, corner of her eye and around it was itching really bad, started hurting and felt strained and started itching in her body was resolved on 03feb2020, whereas the events chills, lightheadedness, tired, headache and muscle aches were resolved on 04Feb2021.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: X-ray
Clinical narrative: Lightheadedness; tired; aches in her hands; corner of her eye and around it was itching really bad; started hurting and felt strained; started itching in her body; Headache; muscle aches; Nausea; Chills; This is spontaneous report from a 78-Year-old Female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number: EL9269), via an unspecified route of administration on 02Feb2021 at single dose for covid-19 immunization on arm left. The patient relevant medical history and concurrent conditions included cataracts from 2005 with ongoing, macular degeneration from 2012 with ongoing, arthritis from an unknown date and ongoing and fingers and both hands that had knots since 2010. The patient stated that she had nausea, chills, headache, and muscle aches on 02Feb2021, and on 03Feb2021, she had lightheadedness, tired, and aches in her hands where she has arthritis and all at once that the corner of her eye and around it was itching really bad and she touched it to relieve the itch and they started hurting and felt strained. The patient got Systane over the counter eye drops that she had and held hot compresses to it. She reported that it lasted for a few hours and she had cataracts and a little macular. The patient started itching in her body at 7:30 and took Benadryl and went to bed and it went away. She was concerned with second vaccine as she got through the nausea and everything else, but her eyes scared her. The patient received treatment medication for nausea and took Tylenol for Arthritis and muscle aches. The patient had an x-ray 3 years ago for her back and was diagnosed for unknown results. The outcome of the events nausea, aches in her hands, corner of her eye and around it was itching really bad, started hurting and felt strained and started itching in her body was resolved on 03feb2020, whereas the events chills, lightheadedness, tired, headache and muscle aches were resolved on 04Feb2021.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling hot, Headache, Myalgia, Pyrexia
Clinical narrative: Headache and was hot; really hot at night; Really strong muscle and joint aches/pain; Really strong muscle and joint aches/pain; fever; White bump near injection site.; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL9262 and expiry date: 31May2021) via Intramuscularly to left arm on 22Jan2021 10:30 at single dose for COVID-19 immunization. Patient medical history included bladder infection, blood pressure, she has some old age stuff like blood pressure, and she had Thyroid removed and takes a thyroid pill every day and she tends toward GERD. Concomitant medications included she does take other medications, but they are not relevant. Patient previously took Shingles shot for Shingles (Had the first of the Shingles shot but it was before that. She is due for the second one but she is putting it off for the COVID second dose). Patient reported that she got the COVID vaccine and was really excited because seemingly, she had no side effects. The shot did not hurt. Ten days after she go the shot, she got really hot at night and really strong muscle and joint aches on 31Jan2021. She was up almost all night. It just kept waking her up. So, she took something, an Ibuprofen thing to reduce fever and pain. The next night she took one proactively and did not have pain. The third night, she had it again but it was a headache all night and she was hot on 02Feb2021. It only seemed to happen at night. She felt like it was from the vaccine. She was not worried she had COVID. She had no breathing problems and did not feel like she was going to pass out. They said she should wait 48 hours and take a test to see if she had COVID. She did and it was negative. She does not feel any negativity toward the vaccine. She went in for a bladder infection and it was from a doctor's appointment that she got information and they told her she could go ahead and get it. Since she got the vaccine, she got white bump in the vicinity of the vaccine like a while mole, and another in the vicinity of the area as well. It does not itch or hurt. She noticed it about a week after the shot. She does not know the date. She was still on medication for a bladder infection but it would not have done anything. When she had reaction to the vaccine, it was already 10 days after she got the shot. She had asked them at Kaiser, and they think it was unrelated to any other medication. Outcome of event fever was recovered on 01Feb2021, for white bump near injection site was not recovered and recovering for all other events.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site mass
Clinical narrative: Headache and was hot; really hot at night; Really strong muscle and joint aches/pain; Really strong muscle and joint aches/pain; fever; White bump near injection site.; This is a spontaneous report from a contactable consumer (patient herself). A 76-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, lot number: EL9262 and expiry date: 31May2021) via Intramuscularly to left arm on 22Jan2021 10:30 at single dose for COVID-19 immunization. Patient medical history included bladder infection, blood pressure, she has some old age stuff like blood pressure, and she had Thyroid removed and takes a thyroid pill every day and she tends toward GERD. Concomitant medications included she does take other medications, but they are not relevant. Patient previously took Shingles shot for Shingles (Had the first of the Shingles shot but it was before that. She is due for the second one but she is putting it off for the COVID second dose). Patient reported that she got the COVID vaccine and was really excited because seemingly, she had no side effects. The shot did not hurt. Ten days after she go the shot, she got really hot at night and really strong muscle and joint aches on 31Jan2021. She was up almost all night. It just kept waking her up. So, she took something, an Ibuprofen thing to reduce fever and pain. The next night she took one proactively and did not have pain. The third night, she had it again but it was a headache all night and she was hot on 02Feb2021. It only seemed to happen at night. She felt like it was from the vaccine. She was not worried she had COVID. She had no breathing problems and did not feel like she was going to pass out. They said she should wait 48 hours and take a test to see if she had COVID. She did and it was negative. She does not feel any negativity toward the vaccine. She went in for a bladder infection and it was from a doctor's appointment that she got information and they told her she could go ahead and get it. Since she got the vaccine, she got white bump in the vicinity of the vaccine like a while mole, and another in the vicinity of the area as well. It does not itch or hurt. She noticed it about a week after the shot. She does not know the date. She was still on medication for a bladder infection but it would not have done anything. When she had reaction to the vaccine, it was already 10 days after she got the shot. She had asked them at Kaiser, and they think it was unrelated to any other medication. Outcome of event fever was recovered on 01Feb2021, for white bump near injection site was not recovered and recovering for all other events.
Sex: U
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, SARS-CoV-2 antibody test negative
Clinical narrative: 2 patients got a result of (-) IGG and (-) IGM; This is a spontaneous report from a contactable physician. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Batch/Lot Number was not reported), dose 2 via an unspecified route of administration on an unspecified date as 0.3 mL, (SINGLE DOSE) for COVID-19 immunization. The patient medical and concomitant medications were not reported. Physician stated that he has 3 patients who received their Pfizer Covid vaccine and had their antibody tests done. 1 patient got a result of (-) IGG and (+) IGM and didn't receive the 2nd dose of the vaccine while the other 2 patients got a result of (-) IGG and (-) IGM which was taken 3 weeks after their 2nd dose. The outcome of the event was unknown.   Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021162118 same reporter/drug/event, different patients;US-PFIZER INC-2021116299 same reporter, drug and event/different patient
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Tooth infection
Clinical narrative: tooth got infected; felt worst every day; This is a spontaneous report from a contactable consumer. A 92-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown), dose 1 via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient stated that, she had her first Covid shot Wednesday a week ago yesterday. Stated the following Saturday her tooth got infected. Called dentist on Sunday who called pharmacy and got some medication. Stated yesterday had to cut tooth out which was not bothering her. Stated had felt worst every day. Wanted to know if the shot had any effect on the antibiotics that she was taking. The patient was taking Cephalexin. Wanted to know if she was going to get better or does she need to stop taking the antibiotic. The patient experienced tooth got infected and felt worst every day on an unspecified date. Outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: SARS-CoV-2 test positive; SARS-CoV-2 test positive; This is a spontaneous report from a contactable Nurse. This Nurse reported similar events for 3 patients. This is 3rd of 3 reports. A 75-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3302, expiry date: unknown), via an unspecified route of administration, in arm on 20Jan2021 (at the age of 84-years-old) at single dose for covid-19 immunisation. The patient medical history was none. Concomitant medications were not reported. The patient was positive for covid on 03Feb2021. The contactable nurse calling about COVID vaccine. She was director at an Assisted Living, and pharmacy administered vaccines to residents on 20Jan2021, and they just had 3 residents, who were positive for COVID, so she wanted to report it in case there was data to look at, to see if they got a bad batch, or was this something that was happening frequently. The second dose scheduled 30 days after the first. The patient underwent lab tests and procedures which included Covid test: positive on 03Feb2021. Outcome of the events was not recovered.  information on the Lot/Batch number has been requested. ; Sender's Comments: Considering a plausible temporal relationship and known product safety profile, a possible contributory role of suspect product comirnaty  to the reported 'COVID 19' cannot be excluded.,Linked Report(s) : US-PFIZER INC-2021162208 same drug and event, different patients;US-PFIZER INC-2021162196 same drug and event, different patients
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: positive for COVID; positive for COVID; This is a spontaneous report received from a contactable Nurse. This Nurse reported similar events for 3 patients. This is 1st of 3 reports. An 80-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL3302), via an unspecified route of administration, administered in Arm on 20Jan2021 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The contactable nurse calling about COVID vaccine. She was director at an Assisted Living, and pharmacy administered vaccines to residents on 20Jan2021, and they just had 3 residents, who were positive for COVID, so she wanted to report it in case there was data to look at, to see if they got a bad batch, or was this something that was happening frequently. The patient experienced positive for COVID on 03Feb2021. The outcome of the events was reported as not recovered.  The information on the Lot/Batch number has been requested.; Sender's Comments: Based on immunization history,patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) on 20Jan2021 at single dose for covid-19 immunization.patient experienced positive for covid on 03Feb2021, which is the 14nth day from dose 1.Resulting in lack of efficacy of given vaccination.The patient becoming COVID positive is most likely an intercurrent condition. However, based on the temporal association, the association between the event Covid positive and the vaccination cannot be completely ruled out.,Linked Report(s) : US-PFIZER INC-2021162196 same drug and event, different patients;US-PFIZER INC-2021162159 same drug and event, different patients
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Pain in extremity
Clinical narrative: After I received my 1st dose i began to have shortness of breath on and off every once in a while; Had very very sore arm; This is a spontaneous report from a contactable consumer (patient).   A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as single dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient reported  after I received my 1st dose I began to have shortness of breath on and off every once in a while and had very sore arm.  The outcome of events was unknow.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Condition aggravated, Feeling cold, Nausea, Tremor
Clinical narrative: she has been freezing since receiving her second COVID-19 Vaccine dose; She said the last 2 days she has been very nauseous. She said she was nauseous all day Thursday, 04Feb2021; Chills; Shaking; She clarified she is always cold, but her coldness seems to be worse at night.; This is a spontaneous report from a contactable consumer. A 82-Year-old female consumer receive second dose of COVID-19 Vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,lot no: EL9262, formulation; solution for injection), via an unspecified route of administration on 03Feb2021, 10:30AM  as single dose at arm left for covid-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot no: EL1284) on Jan2021 for covid-19 immunisation. The patients' Medical history included Partial knee replacement on 16Nov2020, ongoing Diabetes and Spinal stenosis. The patients concomitant medication was not reported.On 03 Feb 2021, the patient had been freezing since receiving her second COVID-19 Vaccine dose, she was nauseous all day , had chills and was shaking.  The patient took Extra Strength Tylenol 500mg. the outcome of event shaking was not recovered, chills and nausea was recovered on 03 Feb 2021.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Weight
Clinical narrative: she has been freezing since receiving her second COVID-19 Vaccine dose; She said the last 2 days she has been very nauseous. She said she was nauseous all day Thursday, 04Feb2021; Chills; Shaking; She clarified she is always cold, but her coldness seems to be worse at night.; This is a spontaneous report from a contactable consumer. A 82-Year-old female consumer receive second dose of COVID-19 Vaccine BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE,lot no: EL9262, formulation; solution for injection), via an unspecified route of administration on 03Feb2021, 10:30AM  as single dose at arm left for covid-19 immunisation. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot no: EL1284) on Jan2021 for covid-19 immunisation. The patients' Medical history included Partial knee replacement on 16Nov2020, ongoing Diabetes and Spinal stenosis. The patients concomitant medication was not reported.On 03 Feb 2021, the patient had been freezing since receiving her second COVID-19 Vaccine dose, she was nauseous all day , had chills and was shaking.  The patient took Extra Strength Tylenol 500mg. the outcome of event shaking was not recovered, chills and nausea was recovered on 03 Feb 2021.