chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Adnexa uteri pain, Breast pain, Musculoskeletal chest pain, Neuralgia, Pain
Clinical narrative: pain on her breast/"shooting pain down below her boobs pulling on the nerves and around the rib cage"; shooting pain down below her boobs pulling on the nerves and around the rib cage"/ and her ovaries shooting like jump like pain; pain on her lower and upper body; shooting pain down below my boobs pulling on the nerves and around the rib cage; shooting pain down below my boobs pulling on the nerves and around the rib cage; my ovaries shooting like jump like pain; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (age: 60 (units unspecified)) received bnt162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: Not reported) via an unspecified route of administration on 21Feb2021 as Dose 1, Single for COVID-19 immunization. The patient's medical history included sensitive to medicines (she tried to stay away from medicines) lower blood count of platelets (borderline). The patient's concomitant medications were not reported. The patient's past medications included flu vaccines (she had no reaction to the flu vaccines). On 21Feb2021 (Sunday) after she received the vaccine she felt like "something happened", yesterday she experienced pain on her breast and pain on her lower and upper body for a couple hours (4 hours), she described it as a "shooting pain down below her boobs pulling on the nerves and around the rib cage", and on her lower body and her ovaries shooting like jump like pain for couple of hours was that part of the vaccine. She had no fever. She queried if she could stay only with the first vaccine and be protected. She was concerned because she's "not heavy enough" and she received the same dose of the vaccine than everyone else, she's also "sensitive to medicines" she tried to stay away from medicines. She stated she would still be using mask to protect herself; she would like to know if she should use mask after receiving the vaccine. She would like to know if the vaccine was effective against the strains of the virus. She would like to know if she can receive the second vaccine in May or later. The patient underwent lab tests and procedures which included blood count platelets: lower blood count of platelets (borderline) on an unspecified date in 2021. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Musculoskeletal stiffness, Pain
Clinical narrative: Stiff neck; Headache; Shooting pains; This is a spontaneous report from a contactable consumer or other non-healthcare professional (patient). An 80-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EC9263, Expiration date: unknown), via an unspecified route of administration in arm right on 19Feb2021 (at the age of 80-years-old) as a dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EC3247, Expiration date was not reported), via an unspecified route of administration in arm left on 29Jan2021 (at the age of 80-years-old) as a dose 1, single for COVID-19 immunization and experienced COVID-19 and sore arm. Enquired, the reporter, who was a female patient, aged 80, received second dose of Pfizer vaccine on 19Feb2021. Stated that, starting Saturday morning on 20Feb2021 and continuing into today, the patient was experiencing a stiff neck, shooting pains and a bad headache. Enquired, was this a side effect of the vaccine. Stated that, she has a very stiff neck that gives her headache and shooting pains when she moves her head at all. Stated that, with her first shot all she had was a sore arm. Stated that, the reporter wanted to know whether this was something they have heard of, related to the vaccine. The events stiff neck, headache and shooting pains when moving head were reported as worsened. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 91.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: swollen and redness at the injection site; swollen and redness at the injection site; This is a spontaneous report from a contactable consumer or other non hcp. This consumer (patient's daughter) reported for a 91-year-old female patient (mother). A 91-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch number/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 18Feb2021 (Age at vaccination 91 years), as dose 2, single for covid-19 immunization. The patient 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 number: not reported /Lot number: EK9231), via an unspecified route of administration on 28Jan2021 (Age at vaccination 91 years), as dose 1, single for covid-19 immunization. The patient experienced swollen and redness at the injection site on 19Feb2021. The caller was a consumer that was calling for her mother. She received the second dose on Thursday the 18Feb2021. She said that on Friday morning her mother had swelling and redness at the injection site. She still had the redness, but not so much the swelling anymore. She clarified that there was still some swelling, but not as much as there had been. She said that there was a 2-3 inch diameter area of redness. She asked, should they be concerned, how long does it last, and was it something that need to get checked? She was made aware of the redness and swelling on 19Feb2021 and her mother first noticed it on Friday 19Feb2021. Caller said that her mother had no allergies to anything. Timeframe between vaccination and starting of symptoms was 1 day. Outcome of the events was recovering.  No follow-up attempts are possible. Information about Lot/Batch cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a sore arm that last a day; .This is a spontaneous report from a contactable consumer or other non hcp (patient). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6198) single dose, via an unspecified route of administration on 29Jan2021 for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had a sore arm that last a day. The patient received the second dose on 19Feb2021. The outcome for the event was recovered.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills
Clinical narrative: chills; upset stomach; This is a spontaneous report from a contactable consumer or other non-health care professional (patient).  A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number was not reported) via an unspecified route of administration on 22Feb2021 as DOSE NUMBER UNKNOWN, SINGLE for COVID-19 immunization. Medical history and concomitant medications were not reported. On 23Feb2021, the patient experienced chills and upset stomach. The outcome of events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Sinusitis
Clinical narrative: sinus infection; ear ache on the left side; This is a spontaneous report from a contactable consumer (Patient). A female patient of unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot number: not reported, Expiry Date: Not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history included Type 1 diabetic. Concomitant medications were not reported. On an unspecified date, the patient experienced sinus infection, and ear ache on the left side. Patient second dose (vaccine) would be next day Wednesday (24Feb2021), don't have any cough, no fever, anything like that. Some doctors said OK, some said to wait. Reporter queried that if she had to wait to receive second dose since the doctor said to wait 1 week and would that be ok, if she gets (vaccine) when you have an infection, would it lessen the strength of the vaccine, not full protection or it could worsen symptoms. she needs to know if she should cancel that second appointment for tomorrow because if she does, she would lose her spot. Therapeutic measures were taken as a result of the event sinus infection which included an antibiotic 5 days ago. Outcome of the events was unknown.  Description of Product Complaint: Caller is calling about the Pfizer COVID 19 vaccine. She had a question; she received the first vaccine 3 weeks ago. She is a Type 1 Insulin dependent diabetic. She seen her doctor for a sinus infection, and she started an antibiotic 5 days ago and she is scheduled for a second appointment. She does not have fever just like more of an earache on the left side. She is getting mixed information because she has multiple doctors, some say yes get the vaccine and some say they are not sure about when you are on an antibiotic, she asks does it lessens the effect of the shot? She actually has another doctor appointment, and she has been on hold for 2 hours the other person told her that she was going to someone who could answer her question, only because she needs to know if she should cancel that second appointment for tomorrow because if she does, she will lose her spot. When she is transferred, is she going to be like number 27 in line again? she does not have time to wait.   No follow up attempts are possible; information on Lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: if I touched the injection site, it was very slightly tender; by the injection site only, it was such a slight amount of soreness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 48-years-old female patient received first dose of BNT162B2(PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 21Feb2021 (age at the time of vaccination 48-years-old), as a single dose for COVID-19 immunization. Medical history included epilepsy. Concomitant medications included venlafaxine hydrochloride (EFFEXOR) as 150 mg (2x every day), and 75 mg (1x every day), lithium carbonate (LITHIUM CARBONATE) as 450 mg (1x every other day), topiramate (TOPIRAMATE) as 100 mg (2x every day), cobamamide (VITAMIN B12 [COBAMAMIDE]) as 1000 mcg, biotin (BIOTIN) as 5000 mcg, vitamin d3 (VITAMIN D3) as 1000 IU, vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]) as 500 mg, and Centrum Multivitamin. On 21Feb2021, the patient experienced if I touched the injection site, it was very slightly tender, and by the injection site only, it was such a slight amount of soreness. The outcome of the events was recovered on 21Feb2021.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot
Clinical narrative: chills and getting chills again; warming back up; This is a spontaneous report from a Pfizer sponsored program reported from a contactable consumer (patient's wife).  A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), second dose via an unspecified route of administration on 08Feb2021 as single along with first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 18Jan2021 as single for covid-19 immunization. The patient medical history and concomitant medications were not reported. The reporter reported that the patient was getting chills and warming back up and getting chills again on an unspecified date of 2021. Reporter stated after each dose her husband experienced chills. The outcome was unknown for the event.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Asthenia, Breast pain, Fear, Headache
Clinical narrative: Stabbing pain; got scared; Sharp pain under the right breast; Arm hurt; Side headache; Anxiety; Felt like her chest was jumping; Felt weak; This is a spontaneous report from a contactable consumer (patient). A 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 20Feb2021 (at the age of 82-years-old) as dose 1 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 21Feb2021 on sunday the patient developed sharp pain under the right breast and got scared. On an unspecified date in Feb2021, patient arm was hurting, got a side headache, got anxiety because she felt like her chest was jumping and laid down and she felt weak. It was reported that on 22Feb2021 she got another stabbing pain but not like the other one. Patient wanted to know if she should go get checked or if it was a part of it. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Palpitations
Clinical narrative: Stabbing pain; got scared; Sharp pain under the right breast; Arm hurt; Side headache; Anxiety; Felt like her chest was jumping; Felt weak; This is a spontaneous report from a contactable consumer (patient). A 82-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 20Feb2021 (at the age of 82-years-old) as dose 1 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 21Feb2021 on sunday the patient developed sharp pain under the right breast and got scared. On an unspecified date in Feb2021, patient arm was hurting, got a side headache, got anxiety because she felt like her chest was jumping and laid down and she felt weak. It was reported that on 22Feb2021 she got another stabbing pain but not like the other one. Patient wanted to know if she should go get checked or if it was a part of it. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site erythema, Vaccination site pain
Clinical narrative: Mild pain and redness at injection site; Mild pain and redness at injection site; mild headache x 24 hours; mild achiness x 24 hrs; tiredness x 24 hrs; This is a spontaneous report from a contactable consumer (Patient). A 61-years-old non-pregnant female patient received bnt162b2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Lot Number: E13247), via an unspecified route of administration, administered in Arm Left on 22Feb2021 11:45 AM (age at vaccination was 61-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included obesity, vitamin d deficiency, Reactive Airway -all from an unknown date and unknown if ongoing. The patient did not have any known allergies. Patient was not pregnant at the time of vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Concomitant medications included montelukast (MONTELUKAST), cetirizine hydrochloride (ZYRTEC ALLERGY) biotin, cyanocobalamin, folic acid (MVI 3) ergocalciferol (VIT D) all from taken for an unspecified indication, start and stop date was not reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient experienced mild pain and redness at injection site, mild headache x 24 hours, mild achiness x 24 hrs and tiredness x 24 hrs on 22Feb2021 15:00. No treatment received for the events reported. The clinical outcome of the events was resolved on an unspecified date in 2021.  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This is a spontaneous report from a contactable consumer or other non hcp (neighbour of patient) via Pfizer sponsored program COVAX US Support.   A female patient of an unspecified age (Age:71, unit: unknown) received bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration on an unspecified date as dose 2, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Historical vaccine included bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: unknown, expiry date: unknown) via an unspecified route of administration on an unspecified date as dose 1, single for covid-19 immunization. On an unknown date, the patient experienced  flu like symptoms. Reporter stated that patient was due to get second shot on Sunday but doctor prescribed a 5 day Z-Pak for her, could she take it before the vaccine or start afterward. Reporter stated that neighbour had a reaction to the second shot with flu like symptoms and told her to take an antihistamine and Tylenol two days prior and two days after. Reported asked if it was recommended. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Pain in extremity
Clinical narrative: felt sick for 4 days/pretty sick; sore red arm; This is a spontaneous report from a contactable consumer (patient, self-reported).   A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, on 09Feb2021, as a single dose for COVID-19 immunization. The patient medical history included COVID-19 in an unspecified date in Nov2020 for 2 weeks but did not have to go to the hospital and recovered. Concomitant medications were not reported. Patient and her husband also received the Pfizer-BioNTech COVID-19 Vaccine first dose 2 weeks ago, on 09Feb2021. On an unspecified date, the patient felt sick for 4 days and had a sore red arm for a week and asked if this is normal. The patient asked is it true that if you had COVID-19, you would get more severe side effects on the vaccine and is it normal to get a pretty good reaction after this first vaccine. Patient and her husband both got pretty sick after getting the vaccine not the day of but the next day. She mentioned her arm was red and sore for about a week. Overall, it took her 4 days before she felt okay. Outcome of the events were unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: a swollen area under his left armpit which is assumed to be a lymph node/swollen area under left arm pit; This is a spontaneous report from a contactable consumer (patient) reported for himself. A 63-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9266, Expiration date: unknown), via an unspecified route of administration, administered in Arm Left on 20Feb2021 13:15 (age at vaccination was 63 years) as dose 2, single for COVID-19 immunization. The patient's medical history and concomitant medications were unknown. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: EL9264, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 30Jan2021 (age at vaccination was 63 years) as dose 1, single for COVID-19 immunization. On 21Feb2021, after second dose the patient experienced a swollen area under his left armpit which is assumed to be a lymph node/swollen area under left arm pit. He described it as being noticeable, pushing outward, significantly wide as compared to the body, and very very very tender but not painful or sore. Patient says that he has had both injections in his left arm, the last one on saturday in the early afternoon. He days on Sunday night under his arm pit area where lymph nodes are he noticed that there was a palm sized area that was wide and not sticking out, and it was still there. He says he would like to know if this was a normal reaction or if he has to run to a doctor or something. He says that the area was tender to touch, but is not horrible pain, and doesn't have any redness. He says he saw that swollen lymph nodes were listed on the paperwork that was given to him on his first visit, he was just a little concerned about if this was normal or an issue. Patient says he got his first dose of the Pfizer COVID-19 vaccine on 30Jan2021 between 01:30PM and 01:40PM, closer to 01:30PM, and it was LOT EL9264. He says he got the second dose 20Feb2021 at 01:15PM, and it was LOT EL9266. He mentioned that he needed his glasses to read handwritten vaccine card, and they did not provide NDC/EXP on it. patient says he has done no treatment to the swollen area, and if it has gone down it has been very minimal. He says tonight will have been two full days of it. He says it is not painful, it is just a wide area under his armpit going down his torso. The outcome of the event was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: sleepy; This is a spontaneous report from a Pfizer-sponsored program. A contactable other hcp reported for 58-year-old male patient (reporter son) received bnt162b2 (BNT162B2, 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. The patient medical history and concomitant medications were not reported. On an unspecified date, She reported that her son, an HCP, received his first dose of the Pfizer COVID-19 vaccine and he was sleepy. The outcome of the event was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Nausea, Vaccination site pain
Clinical narrative: Injection site soreness; headache; nausea; lymphadenopathy; This is a spontaneous report from a contactable consumer or other non hcp via medical information team.  A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration on 23Feb2021 at 11:13 as dose 1, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On 23Feb2021, the patient experienced injection site soreness, headache, nausea and lymphadenopathy. The patient took (paracetamol) TYLENOL for the events. The outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Inappropriate schedule of product administration, Myalgia
Clinical narrative: Headache; Fatigue; Achy muscles; First dose on 11Jan2021 and second dose on 22Feb2021; This is a spontaneous report from a contactable other HCP (Patient). A 46-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in right arm on 22Feb2021 at 11:00 (at the age of 46 years-old) as dose 2, single for COVID-19 immunization. The patient was not pregnant at the time of vaccination. Patient medical history included hypertension and covid-19. The patient had no known allergies. The concomitant medication included ibuprofen. Historical vaccine included BNT162b2 (COMIRNATY, Solution for injection, Lot number- Unknown) via an unspecified route of administration in right arm on 11Jan2021 at 11:00 as dose 1, single for COVID-19 immunization. The vaccination facility type reported as nursing home/senior living facility. There was no other vaccine administered in four weeks. The patient was not tested for COVID post vaccination. The patient experienced headache, fatigue, achy muscles on 23Feb2021 at 13:00 and on 22Feb2021 "First dose on 11Jan2021 and second dose on 22Feb2021". No treatment was received for adverse events. The clinical outcome of events headache, fatigue, achy muscles was recovering.  Information about lot number/batch number has been requested.  Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Dental discomfort, Gingival discomfort, Hypertonia, Oral pain
Clinical narrative: It was like his whole mouth was decayed.; cheek bones hurt; his face got all pulled together and was tingling; his face got all pulled together and was tingling; teeth aching; problems with his teeth or gums.; problems with gums.; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ENG201, Expiry date: not reported), via an unspecified route of administration on 20Feb2021 08:30 (at age of 70-years-old) as dose 1, single for covid-19 immunisation/ to prevent getting COVID virus being aged 70. The patient medical history was not reported. Concomitant medication(s) included metoprolol (METOPROLOL); lisinopril (LISINOPRIL); fluoxetine (FLUOXETINE). Three hours after the vaccine was fine, but his face got all pulled together and was tingling. Since then had been experiencing teeth aches and problems with his teeth or gums. On 20Feb2021, the patient experienced his face got all pulled together and was tingling, teeth aching, problems with his teeth or gums, problems with gum. Last night (on an unspecified date) was so bad, he didn't knew what to do. It was like his whole mouth was decayed. On 23Feb2021 in the morning, his mouth was ok, but his cheek bones hurt. If he presses on some of his rear teeth near his gums and jaw line, he can still feel it. Stated the cheek bones that went down into the jaw bone which hurt. He was getting ready to call his doctor or dentist to make sure it was not a cavity. Did not knew if this was a side effect or how long it will last. Did not knew what he should do. Description of complaint: Patient experienced teeth aches and facial tingling after COVID-19 Vaccine. Doesn't know if it could be a reaction with COVID-19 Vaccine and his Metoprolol, Fluoxetine, and Lisinopril. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Paraesthesia, Toothache
Clinical narrative: It was like his whole mouth was decayed.; cheek bones hurt; his face got all pulled together and was tingling; his face got all pulled together and was tingling; teeth aching; problems with his teeth or gums.; problems with gums.; This is a spontaneous report from a contactable consumer (patient). A 70-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: ENG201, Expiry date: not reported), via an unspecified route of administration on 20Feb2021 08:30 (at age of 70-years-old) as dose 1, single for covid-19 immunisation/ to prevent getting COVID virus being aged 70. The patient medical history was not reported. Concomitant medication(s) included metoprolol (METOPROLOL); lisinopril (LISINOPRIL); fluoxetine (FLUOXETINE). Three hours after the vaccine was fine, but his face got all pulled together and was tingling. Since then had been experiencing teeth aches and problems with his teeth or gums. On 20Feb2021, the patient experienced his face got all pulled together and was tingling, teeth aching, problems with his teeth or gums, problems with gum. Last night (on an unspecified date) was so bad, he didn't knew what to do. It was like his whole mouth was decayed. On 23Feb2021 in the morning, his mouth was ok, but his cheek bones hurt. If he presses on some of his rear teeth near his gums and jaw line, he can still feel it. Stated the cheek bones that went down into the jaw bone which hurt. He was getting ready to call his doctor or dentist to make sure it was not a cavity. Did not knew if this was a side effect or how long it will last. Did not knew what he should do. Description of complaint: Patient experienced teeth aches and facial tingling after COVID-19 Vaccine. Doesn't know if it could be a reaction with COVID-19 Vaccine and his Metoprolol, Fluoxetine, and Lisinopril. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Product storage error
Clinical narrative: 81 vaccines that were improperly cooled; arm was barely sore; This is a spontaneous report received from a contactable consumer (Patient's husband). This consumer reported for a 72-year-old female patient (wife) that. A 72-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: EZ9269) via an unspecified route of administration on 15Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that caller explained he was calling on behalf of his 72-year-old wife who received the first dose of the Pfizer-BioNTech COVID-19 on 15Feb2021. He added it was reported on the news that 81 of the vaccinated people at that location inadvertently received vaccines that were unproperly cooled, and they will get notify for revaccination. He mentioned he was trying to figure out if his wife was part of the 81 individuals who need be revaccinated and asked if we had information. He said that they have not heard anything yet, but he wants to make sure that she did not receive one of the vaccines involved. He explained he called a COVID-19 Vaccination Hotline and they were not able to further assist. He then added his wife's arm was barely sore after the first dose i.e Feb2021 and she was scheduled to receive the second dose on 8Mar2021. Caller further asked if a low reaction, or no reaction to the Pfizer-BioNTech COVID-19 vaccine implies there was no immune response to it. Outcome of event arm was barely sore was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Hyperhidrosis, Nausea
Clinical narrative: dizziness; nausea; intense sweating; This is a spontaneous report from a contactable consumer (patient).  A 68-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration, administered in arm left on 23Feb2021 at 10:00 am (Batch/Lot Number: EN6203) (age at vaccination 68-year-old) as dose 1, single for covid-19 immunisation. The patient had no known allergies. The patient medical history included asthma and lymphoma from an unknown date and unknown if ongoing. There were no concomitant medications reported. The patient did not receive any other vaccines within four weeks prior to the vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Two hours after injection, the patient experienced with dizziness and nausea, followed by intense sweating on 23Feb2021 at 12:00 pm. The patient did not received any treatment for the events. The event ended about a half hour after beginning and were recovered on 23Feb2021.  Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Fall, Gait disturbance, Nausea
Clinical narrative: she was having vertigo/it's vertigo because she notices the room was spinning, she is still having some spinning but it was not like it was before; she threw up/She had vomited just one time in the morning.; Nauseated; she couldn't even sit up; she still tried to walk across the room but then fell over; she still tried to walk across the room but then fell over; felt dizzy a couple times; sore arm; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiration date: Unknown), via an unspecified route, administered in arm left on 21Feb2021 (age at vaccination was 61 years) as DOSE 1, SINGLE for covid-19 immunization. Vaccination facility was old clinic (vaccine center). Vaccine was not administered at military facility. Patient did not have any other vaccines on the same day or in the 4-week period. Medical history included insomnia, ehlers-danlos syndrome hypermobility, PAI clotting disorder (Homozygous), spondylosis in the back, was sick for a day (She doesn't usually get any vaccines, she got the shingles vaccine before and she was sick for a day with flu like symptoms, she has no Lot number for the vaccine), flu like symptoms (she was sick for a day with flu like symptoms); all from an unknown date and unknown if ongoing. She had no relevant family medical history. There were no concomitant medications. Historical vaccine included shingles vaccine. On 22Feb2021, the patient experienced sore arm. On 23Feb2021, the patient got up in the morning and felt dizzy a couple times, she didn't thought much of it. The patient still tried to walk across the room but then fell over, she was having vertigo, she also had threw up. She couldn't even sit up and finally leaned against the wall. She tried to lay down but was nauseated, this had been going on all day, she couldn't go to work. The patient could now walk across the room but she wobbled. The patient clarified that it was not dizziness, it was vertigo because she noticed the room was spinning, and was still having some spinning but it was not like it was before. The patient had vomited just one time in the morning. The patient only called the doctor in response to that vertigo situation and did not go to the office. The patient was told to drink water for vertigo, nausea and vomiting. Therapeutic measures were taken as a result of vertigo, vomiting and nausea. The patient underwent lab tests and procedures which included blood pressure measurement: normal (She did take her blood pressure this morning, and it was normal) on 23Feb2021. No investigation assessment was reported. Outcome of the events sore arm, vertigo, nausea was recovering while event vomiting was recovered with sequel on 23Feb2021. Outcome of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Sitting disability, Vertigo, Vomiting
Clinical narrative: she was having vertigo/it's vertigo because she notices the room was spinning, she is still having some spinning but it was not like it was before; she threw up/She had vomited just one time in the morning.; Nauseated; she couldn't even sit up; she still tried to walk across the room but then fell over; she still tried to walk across the room but then fell over; felt dizzy a couple times; sore arm; This is a spontaneous report from a contactable consumer (patient) via medical information team. A 61-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported, Expiration date: Unknown), via an unspecified route, administered in arm left on 21Feb2021 (age at vaccination was 61 years) as DOSE 1, SINGLE for covid-19 immunization. Vaccination facility was old clinic (vaccine center). Vaccine was not administered at military facility. Patient did not have any other vaccines on the same day or in the 4-week period. Medical history included insomnia, ehlers-danlos syndrome hypermobility, PAI clotting disorder (Homozygous), spondylosis in the back, was sick for a day (She doesn't usually get any vaccines, she got the shingles vaccine before and she was sick for a day with flu like symptoms, she has no Lot number for the vaccine), flu like symptoms (she was sick for a day with flu like symptoms); all from an unknown date and unknown if ongoing. She had no relevant family medical history. There were no concomitant medications. Historical vaccine included shingles vaccine. On 22Feb2021, the patient experienced sore arm. On 23Feb2021, the patient got up in the morning and felt dizzy a couple times, she didn't thought much of it. The patient still tried to walk across the room but then fell over, she was having vertigo, she also had threw up. She couldn't even sit up and finally leaned against the wall. She tried to lay down but was nauseated, this had been going on all day, she couldn't go to work. The patient could now walk across the room but she wobbled. The patient clarified that it was not dizziness, it was vertigo because she noticed the room was spinning, and was still having some spinning but it was not like it was before. The patient had vomited just one time in the morning. The patient only called the doctor in response to that vertigo situation and did not go to the office. The patient was told to drink water for vertigo, nausea and vomiting. Therapeutic measures were taken as a result of vertigo, vomiting and nausea. The patient underwent lab tests and procedures which included blood pressure measurement: normal (She did take her blood pressure this morning, and it was normal) on 23Feb2021. No investigation assessment was reported. Outcome of the events sore arm, vertigo, nausea was recovering while event vomiting was recovered with sequel on 23Feb2021. Outcome of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature decreased, Faeces soft, Fatigue, Feeling abnormal, Headache
Clinical narrative: mild headaches off and on each day, they were very mild; soft bowel movement/bowels are very soft, not diarrhea but soft/soft stool; her arm was really sore more so than ever with flu shot; her hands were cold; her temperature has been below normal for days; feeling strange and tired; feeling strange and tired; This is a spontaneous report from a contactable consumer (patient herself). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6200, Expiry Date: Unknown), via an unspecified route of administration on 17Feb2021 as dose 1, single for COVID-19 immunisation (Age at Vaccination was 81 years). The patient medical history included cataract operation. She has also been on an eye drop several times per day because she had a cataract removed 12Jan2021 and also on 15Dec2020, diverticulosis (used laxative twice per day and she has not had that for 4 days). The patient previously took senior flu shot (dose number was unknown). The patient concomitant medications were not reported. It was stated that she takes different medicines, old age type medicine but nothing in particular. She usually has a lot of energy, and she still does somewhat. It was reported that, the patient did not receive any other products prior vaccination. She got shot 17Feb and she says the first few days her arm was really sore more so than ever with flu shot. Then after than she had mild headaches off and on each day, they were very mild, her hands were cold, her temperature has been below normal for days. She thinks maybe that is why her hands are cold. She also drinks 75-85 ounces of liquid per day and that makes hands cold as well as it is cold outside. On an unspecified date, the patient experienced mild headaches off and, on each day, they were very mild, soft bowel movement/bowels are very soft, not diarrhea but soft/soft stool, her arm was really sore more so than ever with flu shot, her hands were cold, her temperature has been below normal for days, feeling strange and tired (she feels kind of washed out). It was reported that she does not usually have headaches. She confirms she wants to know is headaches and soft stool associated with the product. Her second dose is due on 08Mar2021. The seriousness of the events was considered as non-serious. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral coldness
Clinical narrative: mild headaches off and on each day, they were very mild; soft bowel movement/bowels are very soft, not diarrhea but soft/soft stool; her arm was really sore more so than ever with flu shot; her hands were cold; her temperature has been below normal for days; feeling strange and tired; feeling strange and tired; This is a spontaneous report from a contactable consumer (patient herself). An 81-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6200, Expiry Date: Unknown), via an unspecified route of administration on 17Feb2021 as dose 1, single for COVID-19 immunisation (Age at Vaccination was 81 years). The patient medical history included cataract operation. She has also been on an eye drop several times per day because she had a cataract removed 12Jan2021 and also on 15Dec2020, diverticulosis (used laxative twice per day and she has not had that for 4 days). The patient previously took senior flu shot (dose number was unknown). The patient concomitant medications were not reported. It was stated that she takes different medicines, old age type medicine but nothing in particular. She usually has a lot of energy, and she still does somewhat. It was reported that, the patient did not receive any other products prior vaccination. She got shot 17Feb and she says the first few days her arm was really sore more so than ever with flu shot. Then after than she had mild headaches off and on each day, they were very mild, her hands were cold, her temperature has been below normal for days. She thinks maybe that is why her hands are cold. She also drinks 75-85 ounces of liquid per day and that makes hands cold as well as it is cold outside. On an unspecified date, the patient experienced mild headaches off and, on each day, they were very mild, soft bowel movement/bowels are very soft, not diarrhea but soft/soft stool, her arm was really sore more so than ever with flu shot, her hands were cold, her temperature has been below normal for days, feeling strange and tired (she feels kind of washed out). It was reported that she does not usually have headaches. She confirms she wants to know is headaches and soft stool associated with the product. Her second dose is due on 08Mar2021. The seriousness of the events was considered as non-serious. The outcome of the events was unknown.   No follow-up attempts are possible. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain in injection site; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 74-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), dose 1 via an unspecified route of administration on an unspecified date (at the age of 74-Years-old) (Batch/Lot number was not reported) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history was not reported. Patient's concomitant medication included blood thinner. On an unspecified date, the patient experienced pain in injection site. Patient wanted to know if he could stop his blood thinner medications before getting the second dose pfizer-biontech covid-19 mRNA vaccine. He mentioned that there was no hematoma, and he experienced no side effect aside from the pain in the injection site. At the time of this report, the outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: my arm is quite sore; This is a spontaneous report from Pfizer sponsored program. A contactable female consumer (patient) reported for herself.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number and expiry date was not reported), dose 1 via an unspecified route of administration on 22Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient's medical history included back pain from an unknown date and unknown if ongoing. The patient's concomitant medications included tramadol for back pain. On an unspecified date in Feb2021, the patient experienced my arm is quite sore. The patient was querying about how long she needs to wait before she could take Tylenol or Tramadol for pain. The patient reported "my arm is quite sore" and reported that she usually takes a tramadol daily for a history of back pain. She asked when it would be ok to take the medication. The clinical outcome for the event was unknown.  No follow up attempts are possible; information on Lot/batch number cannot be obtained.
Age: 76.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling hot, Headache, Nausea
Clinical narrative: headache; nausea; hot; This is a spontaneous report from a contactable consumer (patient herself).  A 76-year-old non pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Batch/Lot number: EL8982, Expiry date was not reported), via an unspecified route, administered in the left arm on 22Jan2021 as dose 1, single for COVID-19 immunization. The patient was not pregnant at time of vaccination. The facility type vaccine was public health department. The patient's medical history and concomitant medications were not reported. The patient felt fine all weekend unlike the first one which she had a headache and nausea on 20Feb2021 at 18:00, then the a week later it started on Saturday night very hot on Sunday headache and nausea, this tuesday she still feel bad she understand this can happen up to 1 to 2 weeks after this normal this long she still work been out for 2 days if she cannot work tomorrow she has to have a Dr excuse how long does it go on. The patient receives Pfizer in the left arm on 12Feb2021 at 12:30 (Batch/Lot number: EN6201) other vaccines within four weeks prior to the COVID vaccine. The patient did not receive any concomitant medication within two weeks of vaccination. The patient did not received treatment for the events. The clinical outcome for the events was unknown.  Follow-up attempts completed. No further information expected.