chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Magnetic resonance imaging brain
Clinical narrative: numbing on right side of face/numbness in my right arm; hard time swallowing; dizziness; fogginess; disorientation; hard of hearing; right ear felt very clogged; This is a spontaneous report from a contactable healthcare professional. A male patient of an unspecified age (reported as 43 with unspecified units) received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE and also reported as covid vaccine; unknown lot number and expiration date), via an unspecified route of administration on 11Jan2021 at a single dose for covid-19 immunization. The patient's concomitant medications and medical history were not reported. The patient reported that he received the covid vaccine on Monday late afternoon on 11Jan2021. He reported side effects of numbing on right side of face, hard time swallowing and numbness in his right arm on Jan2021. On Jan2021, he had initial symptoms of dizziness, fogginess and disorientation and then went to bed and woke up with additional symptoms (what he mentioned earlier). The patient added that his right ear felt very clogged and was hard of hearing at the time, but now it has resolved (that was the last thing that went away). The patient inquired if he should get the second dose. He mentioned that all the symptoms cleared up and he inquired as to what are the recommendation. The outcome of the events was recovered on Jan2021.  The following information on the batch/lot number has been requested.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: red and blotchy spots to the arm of injection site; This is a spontaneous report from a contactable consumer. An 83-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EL1283), via an unspecified route of administration on 13Jan2021 13:00 at SINGLE DOSE at arm right for COVID-19 immunization. Medical history included Chronic Lymphomatic Leukemia (CLL), and Heart attack in 2016. The patient's concomitant medications were not reported. The patient had the vaccine 4 hours ago and her whole arm down to the fingers is blotchy red as well as where the injection was given, it's her whole arm, just blotchy red dots. She received the First Dose at 1PM Eastern Time and probably about 2 and a half hours later is when the blotchiness appeared. The patient was experiencing red and blotchy spots to the arm of injection site. Redness and blotchy coloration appear to be under the skin down to her hand and wrist. She asks if this is a normal side effect. She has had no positive test for Covid Before the Vaccine. She has had No Antibody Tests. She has had No issues with vaccines in the past. The outcome of the event was not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Peripheral swelling
Clinical narrative: arm swelled up and she had a lump; arm swelled up and she had a lump; This is a spontaneous report from a contactable Pharmacist. A female patient (age: 70s) received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced arm swelled up and she had a lump on an unspecified date with outcome of unknown.  Information about Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: the rash was getting worse and she had "little bumps"; itching on her back; This is a spontaneous report from a contactable nurse. This nurse reported for self that the female patient of unknown age who received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 23Dec2021 at single dose for covid-19 immunisation. Medical history included allergies: persimmon. Concomitant medications were unknown. Prior to receiving the vaccine she had rashes on her arms which she thinks was a reaction from eating persimmons. She thinks the rash was from organic persimmon fruit since she was eating one a day. She stayed at the facility for an hour after receiving the vaccine and then went home. She states that after receiving the first dose of the vaccine she went home and took a shower and noticed that the rash was getting worse and she had 'little bumps'. On the third day the rash started getting better and now it is completely gone. She realizes that it is hard to tell if the COVID-19 vaccine caused any adverse effects because she already had the skin rash prior to receiving the first dose, however. she is due for the second dose of the vaccine and wants to know if she could safely proceed with getting the second dose. She was taking a shower and she noticed itching on her back and she was scratching and saw bumps. Reports the rashes were a little bit more, and it was not too much itching, and on the third day she took Benadryl. Reports it is all gone now. She was thinking to talk to her doctor and thought it must be from the persimmon fruit since she had the rashes prior to the vaccine. She is asking if she should get the second dose. The outcome of the events was recovered.   Information about Lot/Batch has been requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, SARS-CoV-2 test positive
Clinical narrative: Tested positive for Covid 19 after receiving the vaccine/illness; Tested positive for Covid 19 after receiving the vaccine/illness; This is a spontaneous report from a contactable consumer (patient) from the Pfizer-sponsored program. A 61-years-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EL0140, expiration date: 31Mar2021), via an unspecified route of administration on the upper left arm on 22Dec2020 at a single dose for COVID-19 immunization. There was no medical history and no concomitant medications. The patient received her first dose of the COVID-19 vaccine on 22Dec2020. On 31Dec2020, the patient tested positive for COVID-19. The patient was scheduled to receive her second dose and wanted to know if it is okay to get it, clarified that she was supposed to receive her second shot on 12Jan2021 (the day before the report). The doctor gave her a script that showed that she clinically recovered from illness and okay to get the second vaccine (dose). No treatment was administered for the event. The event "tested positive for COVID-19 after receiving the vaccine/illness" resolved on 13Jan2021.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Malaise, Nasal oedema, Neoplasm skin
Clinical narrative: First day-headache; second day feeling unwell; 3rd day tenderness; lymphadenopathy, right underarm.; swollen lump nose; swollen lump nose; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular in right arm on 07Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included valley fever treatment for 4 months. No known allergies. Concomitant medication included fluconazole. On 07Jan2021 18:00, the patient experienced first day-headache, second day feeling unwell, and third day tenderness/ swollen lump nose, lymphadenopathy, right underarm. Patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Treatment received for the events included TYLENOL tabs. The outcome of the events was not recovered.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Tenderness
Clinical narrative: First day-headache; second day feeling unwell; 3rd day tenderness; lymphadenopathy, right underarm.; swollen lump nose; swollen lump nose; This is a spontaneous report from a contactable nurse. A 49-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number: EL0140), intramuscular in right arm on 07Jan2021 10:30 at a single dose for COVID-19 immunization. Medical history included valley fever treatment for 4 months. No known allergies. Concomitant medication included fluconazole. On 07Jan2021 18:00, the patient experienced first day-headache, second day feeling unwell, and third day tenderness/ swollen lump nose, lymphadenopathy, right underarm. Patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. Treatment received for the events included TYLENOL tabs. The outcome of the events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Developed "a hive" within 24 hours; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, 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. Patient received the first dose of the COVID 19 vaccine and developed "a hive" within 24 hours. Is it safe for them to get a second dose? He has no other information on the patient. The outcome of the event was unknown.   Information on lot/batch number has been requested.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder
Clinical narrative: she felt like her heart was cold; This is a spontaneous report from a contactable consumer (patient) via Medical information team. A 72-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: CL0142), via an unspecified route of administration in left arm on 09Jan2021 at single dose for COVID-19 immunization. Medical history included stage 3 kidney disease and high blood pressure from an unknown date and unknown if ongoing. The patient was asking, "Does the vaccine stay cold in your body? Since the vaccine has to be kept at such a cold temperature in storage when it is injected does it have to stay cold. Is it ok to take the medicine that the doctor has given me along with the vaccine, should I stop or hold some of my medicine?" Is it normal to have a "cold feeling in her heart after getting the vaccine?" The patient stated that she felt like her heart was cold on 12Jan2021 so "I put my hand there to keep it warm". She stated, "Is this normal after getting the vaccine? The patient received her first vaccine dose on Saturday and yesterday she felt like her heart was cold. The patient saw her primary care in Dec2020 for her annual check up and they recommended that she get the vaccine. She is only on her normal medications. She called her doctor to ask if any of her medications could have reacted with the vaccine, but they said to take her medication like usual. The patient stated, "this feeling lasted about an hour." The outcome of the event was recovered on 12Jan2021. No treatment was given to the patient for the event.
Sex: M
Vaccine: COVID19
Symptoms: Neck pain, Pain in extremity, Sleep disorder
Clinical narrative: my arm is hurting; cause his neck to hurt. It is hurting.; might have slept wrong; This is a spontaneous report from a contactable consumer (patient). A male patient of an unspecified age (reported as 66 [units unspecified]) received his first dose of bnt162b2 (BNT162B2 reported as PFIZER-BIONTECH COVID-19 VACCINE; unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient reported that he got the first dose of the vaccine yesterday and his arm was hurting and wondering if it could cause his neck to hurt. It is hurting. He might have slept wrong. The outcome of the events was unknown.  The following information on the batch/lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: he started to have a low grade fever (99F); This is a spontaneous report from a contactable other hcp (patient) reported that a male patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 12Jan2021 at a single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. On Jan2021, the patient stated that he started to have a low grade fever (99F) that has lasted about 25 hours. He wanted to know if this is an expected side effect and how long to expect it. The outcome of the event was unknown.   Information on the Batch/Lot number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Intervertebral disc protrusion, Magnetic resonance imaging, Movement disorder
Clinical narrative: crawling up the stairs on my hands and knees and getting out of bed in agony; bulging disk; severe lower back pain; This is a spontaneous report from a contactable physician (patient). A 62-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The physician (who is also the patient), was asking about the Pfizer COVID19 vaccine for any reports of back pain or back problems/issues. The patient stated: "I got the Pfizer COVID-19 vaccine and got the second dose on Friday (08Jan2021). Over the weekend in Jan2021, I had pretty severe lower back pain that has continued. I had an MRI yesterday morning (12Jan2021) and it showed a bulging disk. I have had issues on and off over the years but nothing like this, ie: I am crawling up the stairs on my hands and knees and getting out of bed in agony. What's interesting is, I called a friend of mine and she had a similar reaction. She has a horrific neck issue and a history of minor lower back issues. She also got the second dose of the Pfizer COVID19 vaccine on Friday and over the weekend she was crawling on her hands and knees as well. That raises a red flag for me. I am trying to determine best treatment options for my back issue, either an epidural steroid or surgery or continue on this 'conservative stuff' (undefined) that's not working. I am meeting with my neurosurgeon tomorrow. Once I mentioned this connection to another person I know, he said he had someone complain of unbelievably severe back pain that lasted a few days." The physician (who is also the patient), also asked about the Pfizer COVID19 vaccine regarding any data on use with steroids and impact on mounting an immune response? If a systemic or local steroid is given, after the vaccine, will it inhibit the body's ability to mount immune response? The patient also asked about concomitant corticosteroids and if "Inhaled (except in Phase 1), topical, or localized injections of corticosteroids (e.g., intraarticular or intrabursal administration) were permitted. What were the percentage of patients on corticosteroids that were included in trials and any assessment off outcomes specifically for this group?" The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on 12Jan2021 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient received the first dose of the Pfizer covid 19 vaccine on 12Jan2021. He wants to verify the Pfizer dose is 3 weeks apart and who can he contact to change his appointment. All of the websites are shut down because there are no appointments available. His second dose is scheduled for 29 days out. Wanted to know if that is okay. Mentioned that he had a sore arm on an unspecified date. Clarified that in the beginning that they were scheduling for Moderna vaccine. They did not have Moderna so they gave him the Pfizer Covid 19 vaccine. He was told that his second one should be in 21 days. The Moderna would have been 28 days. Later clarified that his second dose is scheduled for 30 days later. His is scheduled for 11Feb2021. He cannot get in to schedule anything. No one he asked has the correct answer. Patient does not want to take the vaccine and not have the right scheduling. The outcome of the event sore arm was unknown.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Headache, SARS-CoV-2 test positive
Clinical narrative: The patient developed symptoms on 25Dec2020, tested positive on 31Dec2020; She was supposed to receive second vaccine on 06Jan2021, but put it off; The patient developed symptoms on 25Dec2020, tested positive on 31Dec2020; This is a spontaneous report from a other HCP. A female patient (Age: 45, Unit: Unknown) received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date were not reported), via an unspecified route of administration on 16Dec2020 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported.  The patient developed symptoms on 25Dec2020, tested positive on 31Dec2020. She was supposed to receive second vaccine on 06Jan2021, but put it off because she was told by Pfizer she had to wait 90 days. She was calling for guidance because her hospital was telling her she was eligible to receive the vaccine. She already filed a report with safety when she initially developed symptoms that included loss of smell, taste and headaches. The outcome of the event was unknown.  Information about lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a lack of efficacy with BNT162B2 in this patient cannot be completely excluded.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: worse than the swine flu; This is a spontaneous report from a contactable consumer. A female patient of unspecified age received the second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiration date: unknown), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) for COVID-19 immunization. The patient received the second dose of the vaccine and the side effects was reported as 'worse than the swine flu.' The nurse reported that the side effects lasted 24 hours. The outcome of the event was unknown.   Information about lot/batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Malaise, Pain
Clinical narrative: horrible headache; felt really bad; 102 fever; achy; fatigued; This is a spontaneous report from a contactable other health professional reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 12Jan2021 11:15 AM, at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Medical history included known allergies to penicillin and COVID. The patient had COVID prior to vaccination. Concomitant medications included lisinopril and escitalopram; these are the other medications the patient received in two weeks. The patient previously took betadine and experienced allergies. On 13Jan2021 02:30 AM (as reported), the patient experienced a horrible headache, felt really bad, 102 fever, achy, and fatigued. The patient woke up at about 2:30 am and had a horrible headache. Got out of bed at 4:30 and felt really bad. She had 102 fever. She was still running 100 at 5:42 pm. She was achy, still have a headache and am very fatigued at the time of report. She asked if she can take something for the fever and headache. The patient was not tested for COVID post vaccination. The patient did not receive any treatment for the reported adverse events. Outcome of the events was not recovered.  Information on the Lot/Batch number has been requested.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: horrible headache; felt really bad; 102 fever; achy; fatigued; This is a spontaneous report from a contactable other health professional reporting for herself. A 60-year-old female patient received the first dose of bnt162b2 (BNT162B2, lot number and expiry date were not reported), via an unspecified route of administration, on 12Jan2021 11:15 AM, at a single dose on the left arm for COVID-19 immunization. The vaccine was administered at a hospital. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not pregnant at time of vaccination. Medical history included known allergies to penicillin and COVID. The patient had COVID prior to vaccination. Concomitant medications included lisinopril and escitalopram; these are the other medications the patient received in two weeks. The patient previously took betadine and experienced allergies. On 13Jan2021 02:30 AM (as reported), the patient experienced a horrible headache, felt really bad, 102 fever, achy, and fatigued. The patient woke up at about 2:30 am and had a horrible headache. Got out of bed at 4:30 and felt really bad. She had 102 fever. She was still running 100 at 5:42 pm. She was achy, still have a headache and am very fatigued at the time of report. She asked if she can take something for the fever and headache. The patient was not tested for COVID post vaccination. The patient did not receive any treatment for the reported adverse events. Outcome of the events was not recovered.  Information on the Lot/Batch number has been requested.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, SARS-CoV-2 test
Clinical narrative: my face became numb from the nose down; This is a spontaneous report from a contactable consumer (patient). A 32-year-old female patient received first single dose of BNT162B2 (Solution for injection, lot number: EL3246, exp date not reported), via an unspecified route of administration (vaccine location: right arm) on 11Jan2021 12:30 for COVID-19 immunization. Facility type vaccine: Hospital. The patient had allergies: any sulfa medication. The patient was not pregnant. The patient did not have covid prior vaccination. There were no other vaccine/s in four weeks. Other medications in two weeks include: ethinylestradiol, ferrous fumarate, norethisterone acetate (Blisovi 24 FE), citalopram and lamotrigine. On 11Jan2021 12:45, also reported as 'after 20 minutes of receiving the vaccine,' the patient's face became numb from the nose down. Within three hours, the right side of her face had feeling again. Then, another three hours later she began to have feeling in her nose. She went to bed, and the next morning she had complete feeling in the face. No treatment was received for the event. On 01Jun2020, nasal swab: negative. The patient recovered from the event on 12Jan2021.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: exhausted/ tired; Fever; Chills/she had off and on chills; headache; This is a spontaneous report from a non-contactable nurse. A 29-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, from 11Jan2021 10:00 at a single dose, for covid-19 immunization. The patient has no other relevant medical history (reported as none). There were no concomitant medications used. The patient received her first dose of BNT162B2 on an unspecified date for covid-19 immunization. It was reported that she had an immune response to her 2nd COVID-19 vaccine received on 11Jan2021. She has had a fever, chills and headache during the night (11Jan2021). During the day on 12Jan2021, she had off and on chills and was exhausted. Today, (13Jan2020) patient reported she was feeling better, but still tired. Patient did not received treatment due to events. outcome of events fever, chills and headache was recovering. Outcome of event exhausted/tired was not recovered.   No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Diarrhoea, Eating disorder, Feeling abnormal
Clinical narrative: has not been herself; bad diarrhea; chills; could not eat; feeling "very, very sick; general weakness; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 11Jan2021 to 11Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. It was reported that the patient has not been herself and having bad diarrhea, chills, and general weakness. It was also reported that the patient could not eat and was feeling very, very sick. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: has not been herself; bad diarrhea; chills; could not eat; feeling "very, very sick; general weakness; This is a spontaneous report from a contactable consumer. An 89-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration from 11Jan2021 to 11Jan2021 at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. It was reported that the patient has not been herself and having bad diarrhea, chills, and general weakness. It was also reported that the patient could not eat and was feeling very, very sick. The outcome of the events was unknown.  Information on lot/batch number has been requested.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Allodynia, Headache, Off label use, Product use issue, Vaccination site pain
Clinical narrative: persistent headache; even touching her head hurts/hurts to the touch; with this shot her arm really hurt when getting it/pain in the arm the shot was given/uncomfortable pain/in their arm after receiving the injection; insist on giving the next dose in 4 weeks; insist on giving the next dose in 4 weeks; This is a spontaneous report from a contactable consumer (patient). This consumer reported similar events for two patients. This is the first of two reports.  A 71-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot EL1283) via an unspecified route of administration in the left upper arm on 06Jan2021 09:40 at a single dose as COVID vaccine. The patient had no medical history. Concomitant medications noted as on other medications but nothing new. She previously got the shingle shot for immunization then her arm hurt a few days. She had no other reaction to vaccines in the past. She received no vaccine on the day of or in the prior 4 weeks. Last Wednesday on 06Jan2021, the patient took the vaccine and has had a headache since; even touching her head hurts. She had a persistent headache that started the day after the vaccine and has continued since. The next day on 07Jan2021 was when the headache started. She took regular Motrin (lot OFE3249A, expiry: May2022) and Tylenol extra strength (lot: LMA051, expiry: Jul2019, perhaps not working anymore) sometimes but they didn't really seem to help. She felt the best when she was standing up or laying down, and she would rather be laying down. She asked "Is this a normal side effect, am I dying? I am not a headache kind of person, I take a Motrin, it goes away and I do not have one for months. It actually hurts to the touch." Should she be worried? She did call the clinic about the headache and was told if it got serious to go to the emergency room, she didn't think it was that serious. It was just persistent. She could leave with the pain if it kept her from getting COVID but the fact it was persistent worried her. It was also reported that on 06Jan2021 with this shot her arm really hurt when getting it and that day but that was all (pain in the arm the shot was given), the next night there was no pain. Her and her husband both oooo'd and ahhhh'd with the pain in the arm but that was it (a very uncomfortable pain they experienced in their arm after receiving the injection). She asked how long a side effect lasts after the vaccine? She also stated that on Jan2021, they insist on giving the next dose in 4 weeks. Asked if the vaccine was given a week later would the efficacy be lower? The outcome of persistent headache was not recovered; of vaccination site pain was recovered on 07Jan2021; and of the other events was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021036651 same reporter and drug, different patient and AE
Age: 95.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Headache, Hypoacusis, Memory impairment
Clinical narrative: he has a hearing and memory problem; he has a hearing and memory problem; Very bad headache; Fatigue; Dizziness; This is a spontaneous report from a contactable consumer. A 95-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), via an unspecified route of administration on 11Jan2021 at a single dose for Covid-19 immunization.  The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient has a hearing and memory problem. He later clarified the main thing is he wanted to know if he can continue with getting the second COVID vaccination. He wanted to continue but wanted to know if these symptoms will prevent him from continuing with getting the COVID vaccination. He confirmed he has no problems around the injection site. However, this is the second day and in Jan2021, he had dizziness. On 11Jan2021, last night he had a very bad headache and fatigue. This morning he is feeling better, but he still has slight dizziness. He is still three weeks away from getting the next vaccine. He wanted to know if he would be able to still take it. He wanted to be immune and to know if there would be any reason why he cannot take the second dose of the vaccine. He then mentioned these symptoms that he is speaking of are general symptoms and he assumed other people have reported them along with him because it is listed on the information sheet. Outcome of the events of dizziness, fatigue and headache was recovering, other events was unknown.    Information about batch/lot number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Urticaria
Clinical narrative: hives from head to toe/Her Hives are on her ears, lips, neck, going all the way down to her toes/Hives are worse; first dose on 21Dec2021, second dose on 08Jan2021; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received the second dose of BNT162b2 (Lot: EL3246), via an unspecified route of administration in right arm on 08Jan2021 08:45 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant medication included meloxicam. The patient previously received the first dose of BNT162b2 (Lot: EK5730), at the age of 58-year-old, via an unspecified route of administration in right arm on 21Dec2020 at single dose for covid-19 immunization. She is not allergic to anything at all. She got the 2nd shot on Friday (08Jan2021) 8:45 and then on Sunday (10Jan2021) she had hives from head to toe. She has not tried anything new, no food, products, or detergents. She has no hives at the injection site. Her Hives are on her ears, lips, neck, going all the way down to her toes. At 4 o'clock on 10Jan2021 if when the hives began and by 6 the hives had exploded. Her Hives are worse now. She has had No Positive tests for Covid prior to the vaccine. She has had no antibody test prior to the vaccine. She has had No issues with vaccines in the past. She is using Benadryl to treat her Hives, however it puts her to sleep in 30 minutes and so she cant do that at work. The patient received the first dose on 21Dec2021, second dose on 08Jan2021. The outcome of the event hives was not recovered.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain
Clinical narrative: swollen lymph node under her arm; Pain; This is a spontaneous report from a contactable consumer (patient). A 23-years-old female patient received second dose of bnt162b2 (COVID-19 Vaccine, lot# EL1283), via an unspecified route of administration on 08Jan2021 at single dose on right arm for covid-19 immunisation. Medical history was none. There were no concomitant medications. The patient previously received first dose of COVID-19 Vaccine for COVID-19 immunisation on 18Dec2020. On 09Jan2021, she noticed she had a swollen lymph node under her arm that hadn't gone away. It had gotten more swollen and had spread. The pain had gotten more intense. The pain started as an ache then it was sharp and was now painful to touch. Both conditions were reported as worsen. The event outcome was not recovered.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: Chills; Fever; Diarrhea; This is a spontaneous report from a contactable nurse (patient). A 34-year-old male patient received the second dose of BNT162b2 (Lot/batch number and Expiration date were not provided), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunization. There were no medical history and concomitant medications. The patient experienced fever, chills, and diarrhea on 12Jan2021. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Body height, Chills, Fatigue, Insomnia, Pain
Clinical narrative: tiredness; Chills; Fever; generalized aches; could hardly sleep through the night; This is a spontaneous report from a contactable Physician (patient). A 64-year-old male patient reported received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176  and expiry date: Mar2021) via an unspecified route of administration on 10Jan2021 08:45 at a single dose for COVID-19 immunization. Medical history bypass surgery (10.5 years ago, in June it will be 11 years ago) and hard of hearing. Patient said he used to be 5'7" but right now he is 5'6" or 5'5". He says that change in his height happened before he got the vaccine, that is effects of being short. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and simvastatin. It was reported that the patient had been healthy all his life, he doesn't have any medical conditions which could have contributed to side effects. He does not think they would have contributed but he takes Simvastatin and Baby Aspirin. The patient got the vaccination, the first one (BNT162B2 for COVID-19 immunization, on unspecified date) he did not have anything happen, no side effects or nothing. It was as if he didn't receive any vaccine. The second dose he received it at 8:45 AM on Sunday (10Jan2021) and Sunday night he began experiencing tiredness and then chills, fever, generalized aches and could hardly sleep through the night. It was reported as the worst night in his life and then, fortunately during the day on Monday, gradually, the intensity and severity of the symptoms began to subside but he was not able to do any of his normal functions. Then last night Monday night (11Jan2021) he slept well and today on Tuesday (12Jan2021) he was okay, this morning everything was fine. On Tuesday night he took Acetaminophen for pain, he clarified that was Sunday night after he had gotten the vaccine he took Acetaminophen and he still had the problems then Monday night he thought it would be the same so he put the medicine next to the bed on the night stand but he did not need to take it. He slept and woke up this morning and his back to work. Now it is like nothing has happened. He has recovered completely from all effects. The outcome of the event could hardly sleep through the night was recovered on 11Jan2021 and all the other events recovered on 12Jan2021.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: tiredness; Chills; Fever; generalized aches; could hardly sleep through the night; This is a spontaneous report from a contactable Physician (patient). A 64-year-old male patient reported received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EK4176  and expiry date: Mar2021) via an unspecified route of administration on 10Jan2021 08:45 at a single dose for COVID-19 immunization. Medical history bypass surgery (10.5 years ago, in June it will be 11 years ago) and hard of hearing. Patient said he used to be 5'7" but right now he is 5'6" or 5'5". He says that change in his height happened before he got the vaccine, that is effects of being short. Concomitant medications included acetylsalicylic acid (BABY ASPIRIN) and simvastatin. It was reported that the patient had been healthy all his life, he doesn't have any medical conditions which could have contributed to side effects. He does not think they would have contributed but he takes Simvastatin and Baby Aspirin. The patient got the vaccination, the first one (BNT162B2 for COVID-19 immunization, on unspecified date) he did not have anything happen, no side effects or nothing. It was as if he didn't receive any vaccine. The second dose he received it at 8:45 AM on Sunday (10Jan2021) and Sunday night he began experiencing tiredness and then chills, fever, generalized aches and could hardly sleep through the night. It was reported as the worst night in his life and then, fortunately during the day on Monday, gradually, the intensity and severity of the symptoms began to subside but he was not able to do any of his normal functions. Then last night Monday night (11Jan2021) he slept well and today on Tuesday (12Jan2021) he was okay, this morning everything was fine. On Tuesday night he took Acetaminophen for pain, he clarified that was Sunday night after he had gotten the vaccine he took Acetaminophen and he still had the problems then Monday night he thought it would be the same so he put the medicine next to the bed on the night stand but he did not need to take it. He slept and woke up this morning and his back to work. Now it is like nothing has happened. He has recovered completely from all effects. The outcome of the event could hardly sleep through the night was recovered on 11Jan2021 and all the other events recovered on 12Jan2021.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Auditory nerve disorder, Chills, Migraine, Nasal congestion
Clinical narrative: nuchal rigidity; migraine; photosensitivity; auditory sensitivity; arthralgia; lethargy chills/ rigors; nasal stuffiness; chest congestion; wet cough; This is a spontaneous report from a contactable physician. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1283), intramuscular on 08Jan2021 17:00 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient had the first dose last 18Dec2020 (lot number=EJ1685). The patient experienced nuchal rigidity, migraine, photosensitivity, auditory sensitivity, arthralgia, lethargy chills, rigors, nasal stuffiness, chest congestion, wet cough on 09Jan2021 05:00. The outcome of the event nuchal rigidity was not recovered while other events were recovered with sequelae.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Nuchal rigidity, Photosensitivity reaction, Productive cough, Respiratory tract congestion
Clinical narrative: nuchal rigidity; migraine; photosensitivity; auditory sensitivity; arthralgia; lethargy chills/ rigors; nasal stuffiness; chest congestion; wet cough; This is a spontaneous report from a contactable physician. A 40-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number:EL1283), intramuscular on 08Jan2021 17:00 at a SINGLE DOSE for covid-19 immunisation. The patient's medical history was not reported. There were no concomitant medications. The patient had the first dose last 18Dec2020 (lot number=EJ1685). The patient experienced nuchal rigidity, migraine, photosensitivity, auditory sensitivity, arthralgia, lethargy chills, rigors, nasal stuffiness, chest congestion, wet cough on 09Jan2021 05:00. The outcome of the event nuchal rigidity was not recovered while other events were recovered with sequelae.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Lymph node pain, Lymphadenopathy
Clinical narrative: Enlarged lymph nodes on the left side of her neck and under the left armpit; Flu like symptoms; The lymph nodes are also a little painful.; This is a spontaneous report from a contactable consumer (patient). A 29-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL0142), via an unspecified route of administration on 06Jan2021 at single dose by injection in the left arm for covid-19 immunization. The patient had no medical history. There were no concomitant medications. The patient experienced flu like symptoms on 10Jan2021, enlarged lymph nodes on the left side of her neck and under the left armpit on 11Jan2021, the lymph nodes are also a little painful in Jan2021, this is on the same side that she received the vaccine, on the left. The outcome of the events was not recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Tinnitus, Upper respiratory tract congestion
Clinical narrative: sinus infection; stuffy head; I do have tinnitus, and noticed that both injections made that worse; This is a spontaneous report from a contactable nurse (patient).  A 63-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date not reported), intramuscular on the left arm, on 18Dec2020 at 11:30 at a single dose for Covid-19 immunization.  Medical history included at one time a severe allergic reaction to pecans have since eaten small amts without problems and tinnitus.  The patient has no Covid prior to vaccination. The patient is not pregnant. The patient's concomitant medications were not reported. No other vaccines in four weeks and no other medication in two weeks. In Dec2020, the patient stated that she does have tinnitus, and noticed that both injections made that worse, it is not yet subsiding since last injection the only other signs and symptoms (s/s) she had from the 1st injection, second day after, about 2 hrs of feeling like she had a sinus infection, stuffy head, wanted to go to bed and rest. The patient was treated with naproxen sodium (ALEVE), paracetamol (TYLENOL), and diphenhydramine hydrochloride (BENADRYL) for the events. The patient was not Covid tested post vaccination. The outcome of the event of tinnitus was not recovered, while other events were unknown.   Information on lot/batch number has been requested.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold symptoms; This is a spontaneous report from a contactable consumer patient. This 55-year old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248) shot at single dose on 11Jan2021 via an unknown route at left arm Covid-19 vaccination. Medical history and concomitant drug were reported as "none".  Patient stated that she got a shot yesterday (11Jan2021) and had cold symptoms today (12Jan2021), and further stated that the cold symptoms come and go.  No investigation assessment performed. No treatment performed.  Outcome of the event was resolving.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Chills, Decreased appetite, Feeling of body temperature change, Pain in extremity
Clinical narrative: arm got sore instantly; I have no feeling in fingertips; chills; shakes; fever; hot cold; itchy out of control; no appetite is forcing food; is drinking a lot, can't get enough liquid in me; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# el1283), 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. Caller reported that she was supposed to get the shot, got to her vaccination provider was told she was getting the Pfizer shot. She reported that she was on antibiotics and had blood work done the week before, was told that was fine. She reported that she took the shot and stated her arm got sore instantly. She went to leave she was asked how she was and reported, she had no feeling in fingertips and reported that they said that was ok. Caller reported that Monday night she started having chills, shakes and fever, hot cold, now since yesterday and all day today she was itchy out of control. Caller stated she was not going back for the second shot. Caller went on to report she had no appetite was forcing food and was drinking a lot, can't get enough liquid in her. Outcome of events were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Polydipsia, Pruritus, Pyrexia, Sensory loss, Tremor
Clinical narrative: arm got sore instantly; I have no feeling in fingertips; chills; shakes; fever; hot cold; itchy out of control; no appetite is forcing food; is drinking a lot, can't get enough liquid in me; This is a spontaneous report from a contactable consumer (patient herself). A 65-year-old female patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# el1283), 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. Caller reported that she was supposed to get the shot, got to her vaccination provider was told she was getting the Pfizer shot. She reported that she was on antibiotics and had blood work done the week before, was told that was fine. She reported that she took the shot and stated her arm got sore instantly. She went to leave she was asked how she was and reported, she had no feeling in fingertips and reported that they said that was ok. Caller reported that Monday night she started having chills, shakes and fever, hot cold, now since yesterday and all day today she was itchy out of control. Caller stated she was not going back for the second shot. Caller went on to report she had no appetite was forcing food and was drinking a lot, can't get enough liquid in her. Outcome of events were unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Headache, Hypertension
Clinical narrative: Dizziness within 15 minutes of receiving vaccine; headache; high blood pressure; This is a spontaneous report from a contactable other health care professional. A 29-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; lot number: EK5730), intramuscular on 24Dec2020 08:00 at SINGLE DOSE at right arm for COVID-19 immunization. Medical history included allergic to nuts and peaches.  There were no concomitant medications. On 24Dec2020 08:15, the patient experienced Dizziness within 15 minutes of receiving vaccine; couple of hours after patient reported headache and high blood pressure x2 days. After 2 days both headache and high blood pressure subsided. The patient received treatment for the event headache (Tylenol). It was reported that the patient had a physician office visit. The outcome of the event dizziness was recovered on an unspecified date, while the events headache and hypertension was recovered on 26Dec2020.