chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Got the first dose of the vaccine on 23Dec2020, this week the patient was tested positive for COVID; Got the first dose of the vaccine on 23Dec2020, this week the patient was tested positive for COVID; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect from a contactable other healthcare professional (HCP) (patient). A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 23Dec2020 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient got the first dose of the vaccine on 23Dec2020, this week the patient was tested positive for COVID in Jan2021. The outcome of the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: The reported tested positive for COVID  after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: she tested positive in the middle; she tested positive in the middle; This is a spontaneous report from a contactable female consumer (patient) via a Pfizer-sponsored program . A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 16Dec2020 at first single dose for COVID-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. Caller was asking if it was safe for her to get the second dose, she had the 1st dose on the 16Dec2020 and scheduled for the second dose today (reported on 06Jan2021), however she tested positive in the middle. Outcome of the event was unknown.  information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report from a contactable healthcare professional (HCP) reporting for himself via a Pfizer-sponsored program Pfizer First Connect. A male patient of an unspecified age received the first single dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number and expiry date not reported) via an unspecified route of administration on 21Dec2020 for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient was tested positive for COVID-19 on 28Dec2020 and he was wondering if he was still able to receive the second dose of the vaccine. The outcome of the event was unknown.  Information on the lot/ batch number has been requested.; Sender's Comments: The reported tested positive for COVID-19 after COVID-19 immunization is considered ineffective of BNT162B2, and the Company cannot completely exclude the possible causality between the reported event and BNT162B2 administration.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: some arm soreness in the injected arm; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on arm, via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported he had already received his first dose of the Pfizer covid-19 vaccine and tolerated it well, but he did experience some arm soreness in the injected arm. The outcome of event was recovered.  Information on the Lot/Batch number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: some rashes on her face; This is a spontaneous report from a Pfizer-sponsored program, from a contactable consumer (patient). A female patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 04Jan2021 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had some rashes on her face on 06Jan2021. She would like to know if it's okay to take diphenhydramine hydrochloride (BENADRYL). The outcome of event was unknown.  Information on the lot/batch number has been requested
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Diarrhoea
Clinical narrative: diarrhea; loss of smell and taste; loss of smell and taste; This is a spontaneous report from a non-contactable pharmacist. A 72-year-old male patient received BNT162B2 (Pfizer/ BioNTech Covid-19 vaccine) at a single dose on an unspecified date for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. After the vaccination, the patient experienced diarrhea and loss of smell and taste. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Myalgia, Pyrexia
Clinical narrative: I still feel little bit fatigue during the day but nothing compared to the evening hours; Joint pain; Muscle pain; Fever only last about only 2 hours and then it goes away; This is a spontaneous report from a contactable consumer (patient).  A 38-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 31Dec2020 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported.  The patient reported that: "during the day I feel almost like 80%, I still feel little bit fatigue during the day but nothing compared to the evening hours, in the evening hours and in the early morning, I am getting like severe joint pain, muscle pain and I also come down with fever from last two nights but the fever only last about only 2 hours and then it goes away". The patient outcome of fever was recovered, the outcome of the other events was unknown.  Information on Lot/Batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Rhinalgia, Rhinorrhoea
Clinical narrative: Pain; I never had a sinus effect but it feels like stuffy and painful in my nose and running a little bit; I never had a sinus effect but it feels like stuffy and painful in my nose and running a little bit; I never had a sinus effect but it feels like stuffy and painful in my nose and running a little bit; This is a spontaneous report from a contactable consumer (patient).  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number Unknown, via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient reported that was okay for an hour and then suddenly the patient on an unspecified date experienced pain and felt like stuffy and painful in patient nose and running a little bit.  The patient was treated with BENADRYL. The outcome of the events was recovering.  Information on the lot/batch number has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Chills, Pain
Clinical narrative: I am running my temperature 100.1; Chills; Body is still painful; my body achy, my back hurts; every joints hurt in me; Body is still painful; my body achy, my back hurts; every joints hurt in me; Body is still painful; my body achy, my back hurts; every joints hurt in me; This is a spontaneous report from a contactable consumer (patient) and a contactable other health professional.  A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. On Jan2021, the patient reported that: "I am running my temperature 100.1, chills in my body and my body is still painful. I don't have shortness of breath, but I am very painful. I took 2 TYLENOL. I woke with chills, I have my body achy, my back hurts. I am in pain, every joint hurt in me. I took my temperature and I realized it was 100.1". The patient outcome of fever and chills was unknown, the outcome of the other events was not recovered.   Information on Lot/Batch has been requested.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: I am running my temperature 100.1; Chills; Body is still painful; my body achy, my back hurts; every joints hurt in me; Body is still painful; my body achy, my back hurts; every joints hurt in me; Body is still painful; my body achy, my back hurts; every joints hurt in me; This is a spontaneous report from a contactable consumer (patient) and a contactable other health professional.  A 54-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 04Jan2021 at single dose for COVID-19 immunization. The patient medical history was none. There were no concomitant medications. On Jan2021, the patient reported that: "I am running my temperature 100.1, chills in my body and my body is still painful. I don't have shortness of breath, but I am very painful. I took 2 TYLENOL. I woke with chills, I have my body achy, my back hurts. I am in pain, every joint hurt in me. I took my temperature and I realized it was 100.1". The patient outcome of fever and chills was unknown, the outcome of the other events was not recovered.   Information on Lot/Batch has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Middle insomnia, Sleep disorder
Clinical narrative: I have had since then sleeping disturbances which means I woke several times in the night; I have had since then sleeping disturbances which means I woke several times in the night; This is a spontaneous report from a non-contactable physician who reported for themselves. A patient of unspecified age and unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) via an unspecified route of administration on an unspecified date (at an unspecified age) as a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient experienced "I have had since then sleeping disturbances which means I woke several times in the night" on an unspecified date. The patient called and stated that they were a family doctor and had a question about the COVID-19 vaccine. The patient reported that they "got this vaccine about a week ago and I have had since then sleeping disturbances which means I woke several times in the night. The question is if the company has experienced any complaints for it." The patient was informed about the Pfizer Medical Information department and as department was closed the telephone number was provided. The clinical outcome of the event "I have had since then sleeping disturbances which means I woke several times in the night" was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Neuropathy peripheral, Paraesthesia
Clinical narrative: Peripheral neuropathy. Needles and tingling from finger tips to shoulder - bilateral. More pronounced in left arm where vaccine was administered. Sensation lasted about 30 minutes and then subsequently subsided. No treatment needed. No further symptoms the following day besides injection site soreness.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Chills, Cough, Headache
Clinical narrative: Coughing; chills; she is feeling like a headache, might be from all the coughing; she threw up a yellow stuff, I think the yellow mucous or acid; Fever; This is a spontaneous report from a contactable consumer (patient's spouse) via a Pfizer-Sponsored Program, Pfizer First Connect. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EL1284) via an unspecified route of administration on 04Jan2021 (at the age of 33-years-old) as a single dose for COVID-19 immunization. Medical history was reported as "none". Concomitant medications were not reported. The patient experienced "coughing", "chills", "she is feeling like a headache, might be from all the coughing", "she threw up a yellow stuff, I think the yellow mucous or acid" and "fever", all on unspecified dates. It was reported that "the reporter called concerned about his wife who got the Pfizer BioNTech COVID-19 vaccine "yesterday" and then she started coughing and experienced a fever." The reporter stated "she was coughing a lot and she threw up a yellow stuff, I think the yellow mucous or acid or whatever. She had a fever that peaked till 100. I gave her Aspirin, it dropped down to 98 at the moment, but she was still having chills." The reported stated that "I just gave Aspirin for the fever. She said at the back of her neck you know she said that she is feeling like a headache, might be from all the coughing." The patient underwent lab tests reported as "got blood work for allergies and stuff like that". When inquired regarding the indication, the reporter stated, "she was caring for my uncle who is 65 and older". The reported stated "I feel that it is recovering, it's getting better".  The clinical outcome of the event "chills" was not recovered/not resolved whereas the clinical outcomes of the events "coughing", "she is feeling like a headache, might be from all the coughing", "she threw up a yellow stuff, I think the yellow mucous or acid" and "fever" were all unknown.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Coughing; chills; she is feeling like a headache, might be from all the coughing; she threw up a yellow stuff, I think the yellow mucous or acid; Fever; This is a spontaneous report from a contactable consumer (patient's spouse) via a Pfizer-Sponsored Program, Pfizer First Connect. A 33-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot #: EL1284) via an unspecified route of administration on 04Jan2021 (at the age of 33-years-old) as a single dose for COVID-19 immunization. Medical history was reported as "none". Concomitant medications were not reported. The patient experienced "coughing", "chills", "she is feeling like a headache, might be from all the coughing", "she threw up a yellow stuff, I think the yellow mucous or acid" and "fever", all on unspecified dates. It was reported that "the reporter called concerned about his wife who got the Pfizer BioNTech COVID-19 vaccine "yesterday" and then she started coughing and experienced a fever." The reporter stated "she was coughing a lot and she threw up a yellow stuff, I think the yellow mucous or acid or whatever. She had a fever that peaked till 100. I gave her Aspirin, it dropped down to 98 at the moment, but she was still having chills." The reported stated that "I just gave Aspirin for the fever. She said at the back of her neck you know she said that she is feeling like a headache, might be from all the coughing." The patient underwent lab tests reported as "got blood work for allergies and stuff like that". When inquired regarding the indication, the reporter stated, "she was caring for my uncle who is 65 and older". The reported stated "I feel that it is recovering, it's getting better".  The clinical outcome of the event "chills" was not recovered/not resolved whereas the clinical outcomes of the events "coughing", "she is feeling like a headache, might be from all the coughing", "she threw up a yellow stuff, I think the yellow mucous or acid" and "fever" were all unknown.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Headache, Loss of personal independence in daily activities, Malaise
Clinical narrative: I just need to lay down I can barely sit up; Headache; I wasn't feeling good; My body is sore; Fever of a 101°F; Diarrhea; I threw up a little bit in the bathroom; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 31Dec2020 for Covid-19 immunisation.  Medical history included Covid-19 in Aug2020. Concomitant medications were not reported.  The patient stated that, on 04Jan2021 developed headache, I wasn't feeling good, my body is sore, fever of a 101°F, diarrhea, I threw up a little bit in the bathroom. The patient also reported that "I just need to lay down I can barely sit up on an unspecified date. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vomiting
Clinical narrative: I just need to lay down I can barely sit up; Headache; I wasn't feeling good; My body is sore; Fever of a 101°F; Diarrhea; I threw up a little bit in the bathroom; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration at single dose on 31Dec2020 for Covid-19 immunisation.  Medical history included Covid-19 in Aug2020. Concomitant medications were not reported.  The patient stated that, on 04Jan2021 developed headache, I wasn't feeling good, my body is sore, fever of a 101°F, diarrhea, I threw up a little bit in the bathroom. The patient also reported that "I just need to lay down I can barely sit up on an unspecified date. The outcome of events was unknown.  Information on the lot/batch number has been requested.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Itching 2 days after it was given.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I am having bad rash all over; I started getting in middle in my back and now it just everywhere; This is a spontaneous report from a contactable consumer reporting for herself.  A 48-years-old female patient received bnt162b2 ((PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration in the right arm on 03Jan2021 at single dose for COVID-19 immunization. Medical history was none. There were no concomitant medications. The patient experienced bad rash all over; she started getting in middle in her back and now it just everywhere on 03Jan2021 shortly after vaccination with outcome of unknown. The patient was doing anti-histamine and hydrocortisone cream as treatment.  Information on the Batch/Lot number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives; Itching like a crazy person; This is a spontaneous report from a contactable other health professional (Nurse Practitioner). A 39-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EK5730), intramuscular on 22Dec2020 at single dose on left arm for COVID-19 immunization. Medical history included heavy (Other medical conditions: Consumer stated, "No, I'm healthy other than being a little heavy"). There were no concomitant medications. Patient stated, "I filled out the 'app' after I got my Pfizer Vaccine the first one on 22Dec (Clarification Unknown) but I believe that I have been having a reaction to the vaccination and wanted some kind of guidance on moving forward with the booster and kind of what I should do?" The patient experienced hives and itching like a crazy person when she got the vaccine, 22Dec2020. Treatment in response to treatment, patient stated, "I have taken a lot. It's hives and itching like a crazy person. So I have been take Ibuprofen, and antihistamines like Claritin, Zyrtec and Benadryl." The outcome of the events was recovering ("I would say may be persistent, may be slight improvement"). The events were related to suspect drug as per reporter.
Sex: U
Vaccine: COVID19
Symptoms: Malaise, Pain, Pain in extremity, Pyrexia
Clinical narrative: Bad fever; Body ache; can't get up with arm, really sore; really not feeling good; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0140), via an unspecified route of administration, on 04Jan2021 as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced bad fever, body ache, can't get up with arm, really sore, and really not feeling good. The clinical outcome of  bad fever, body ache, can't get up with arm, really sore, and really not feeling good was unknown.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspepsia, Pain in extremity, Somnolence
Clinical narrative: MODERNA COVID-19 VACCINE EUA After the vaccine felt sleepy all day but could conduct my daily life. Left arm became sore during the night. Heartburn during the night, had trouble sleeping due to heartburn. Heartburn was stronger than my usual GERD.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chest discomfort, Dizziness, Dyspnoea, Erythema
Clinical narrative: Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness; Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient.   A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization.   There were no known medical history or concomitant medications.  The patient previously received the first dose of BNT162B2 on 18Dec2020 (Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10 minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN).  Later on 08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen (MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Headache, Hyperhidrosis, Rash, Tachycardia
Clinical narrative: Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness; Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient.   A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization.   There were no known medical history or concomitant medications.  The patient previously received the first dose of BNT162B2 on 18Dec2020 (Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10 minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN).  Later on 08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen (MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Anaphylactic reaction; Flushed; Diaphoretic; redness and rash; hives on chest; Tachycardia; shortness of breath; Chest tightness; Dizziness; Headache; This is a spontaneous report from a contactable nurse, the patient.   A 47-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1283), via an unspecified route of administration on 08Jan2021 at 08:49 (at the age of 47-years-old) as a single dose for COVID-19 immunization.   There were no known medical history or concomitant medications.  The patient previously received the first dose of BNT162B2 on 18Dec2020 (Lot Number: EK5730) for COVID-19 immunization and experienced nausea, headache, and fatigue. On 08Jan2021, about 5-10 minutes after the second dose, the patient experienced anaphylactic reaction, flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness, reported as life-threatening. She reported that these events occurred within less than 10 minutes of receiving the vaccine. She went to the emergency room and was treated with methylprednisolone (SOLUMEDROL), diphenhydramine hydrochloride (BENADRYL), famotidine (PEPCID), and epinephrine (MANUFACTURER UNKNOWN). She was sent home and prescribed methylprednisolone and epinephrine (EPI-PEN).  Later on 08Jan2021, she experienced dizziness and headache, which were consistent. She stated she would most likely take ibuprofen (MOTRIN) as treatment (not specified if taken). The clinical outcomes of the flushed, diaphoretic, redness and rash, hives on chest, tachycardia, shortness of breath, and chest tightness were recovered on 08Jan2021; while the outcomes of the dizziness and headache were not recovered and that of the anaphylaxis was reported as recovering.; Sender's Comments: The reported information is limited. Based on the close temporal relationship and the description of the events, there is a reasonable possibility that the events are related to BNT162 vaccine. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Laboratory test, Myalgia, Neck pain
Clinical narrative: Head hurting really bad; Bad muscle pain all across shoulder and neck; Bad muscle pain all across shoulder and neck; some other joint pain too; This is a spontaneous report from a contactable consumer, regarding the reporter's mother. An 89-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot number: EL0140; Expiration date: 31Mar2021), via an unspecified route of administration, on 29Dec2020 (at the age of 89-years-old) at a single dose for COVID-19 immunization. Medical history included blood pressure, heart problems, back issues, hip issues, and kidney problems. The patient's concomitant medications were not reported. The patient experienced head hurting really bad, bad muscle pain all across shoulder and neck, and some other joint pain too on an unspecified date. The clinical course was reported as follows: The reporter called regarding their mother, who was vaccinated on 29Dec2020. The patient's head was hurting really bad, which she never has a headache and was having bad muscle pain all across her shoulder and neck. The patient was given paracetamol (TYLENOL ARTHRITIS) 650 mg and heat pad. She was having some other joint pain too and the fever was fine. The patient underwent lab tests and procedures which included lab work: unknown results on an unspecified date. Therapeutic measures were taken as a result of the events as aforementioned. The clinical outcome of head hurting really bad, bad muscle pain all across shoulder and neck, and some other joint pain too was unknown.  The batch/lot number for the vaccine, BNT162B2, was provided, but will be confirmed/requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy, Muscle spasms
Clinical narrative: glands in throat really swollen; muscles in right leg started spasming; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced glands in throat really swollen and muscles in right leg started spasming on an unspecified date. The clinical course was reported as: The patient received the vaccine and woke up with glands really swollen and, in the evening, muscles in legs started spasming in right leg. The muscle spasms persisted over the last day or so. The clinical outcome of glands in throat really swollen and muscles in right leg started spasming was unknown.  The batch/lot number for the vaccine, BNT162B2, was not provided and has been requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Injection site  swelled , was sore, became itchy, and was hot to the touch. It began the evening of 1/8/21 as tenderness and itchy but increased in size, temperature, and increased tenderness and itch the evening of 1/9/21. I took 3 ibuprofen and iced for 30 minutes. By morning, swelling was down and not as sore. Site still remains itchy at times.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pre-existing condition improved, Therapeutic response unexpected
Clinical narrative: when they put the vaccine into the patient's deltoid, it helped the patient's shoulder have more range of motion just a little bit; when they put the vaccine into the patient's deltoid, it helped the patient's shoulder have more range of motion just a little bit; This is a spontaneous report from a contactable consumer (EMT, Emergency Medical Technician).  A 59-year-old female patient received the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number and Expiration Date: unknown), via an unspecified route of administration in the deltoid on 30Dec2020 at 59-years-old at a single dose for COVID-19 immunization. Medical history included bad shoulder from an unknown date and unknown if ongoing. Concomitant medications included vitamins from an unspecified date to an unspecified date. On an unspecified date, the patient experienced: when they put the vaccine into the patient's deltoid, it helped the patient's shoulder have more range of motion just a little bit. The clinical course was reported as follows: The patient stated, "so everybody is talking about the negative, the adverse reactions, but I would like to perhaps report a positive reaction." The patient had a bad shoulder for 10 or 15 years. The administrating professional put the vaccine into the patient's deltoid ("my shoulder muscle"). The patient stated, "I don't know, maybe it helped my shoulder have more range of motion just a little bit."  The clinical outcome of the events: unexpected therapeutic effect and pre-existing condition improved, was unknown.   No follow-up attempts are needed; information about batch/lot number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This is a spontaneous report from a contactable consumer (patient 's wife).  A male patient of unknown age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 03Jan2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. The patient was having some issues, he says he keeps getting dizziness. Outcome is unknown. Information on the lot/batch number has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills; Fever; Body ache; This is a spontaneous report from a contactable consumer, the patient.  A 44-year-old female patient  received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration on 03Jan2021 (at the age of 44-year-old) as a single dose for COVID-19 immunization. Medical history included already tested positive for COVID.  There were no concomitant medications. On 04Jan2021 the patient experienced chills, fever, and body ache. Therapeutic measures taken as a result of chills, fever, and body ache included Tylenol 500 mg. The clinical outcome of the events chills, fever, and body ache was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Twelve hours after dose: headache, diarrhea, myalgia, cervical lymphadenopathy, nausea, fatigue. Side effects improved by 48 hours after injection and completely resolved by 72 hours after injection.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Twelve hours after dose: headache, diarrhea, myalgia, cervical lymphadenopathy, nausea, fatigue. Side effects improved by 48 hours after injection and completely resolved by 72 hours after injection.
Sex: U
Vaccine: HEPA, UNK
Symptoms: Hepatitis A immunisation, Product storage error, Prophylaxis
Clinical narrative: a VAQTA vaccine which had been improperly stored was administered to a patient.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information about medical history, concurrent conditions and concomitant therapies was not provided.    On 28-DEC-2020, the patient was vaccinated with improperly stored hepatitis a vaccine, inactivated(VAQTA) (lot # T013204, expiration date 03-DEC-2021, 1 injection) for prophylaxis (product storage error). The temperature excursion was supported, at below 36 Fahrenheit degree (32.1 Fahrenheit degree) for 5 hours and 40 minutes. There were no previous excursions, and a data logger was used. combinationproductreport: Yes; brandname: VAQTA SYRINGE (DEVICE); commondevicename: Hepatitis A Vaccine, Inactivated; productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: T013204; expirationdate: 03-DEC-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Age: 67.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Asthenia, Feeling hot, Muscular weakness, Pain, Pain in extremity
Clinical narrative: arm sore / pain in right arm; weakness in right arm; Today patient was in a lot of pain / worse during lateral movements or / raises her arm above her head; weakness are worse during lateral movements / raises her arm above her head; right arm was hot for 3  days; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number MT7C9, expiry date unknown) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Previously administered products included Pneumonia vaccine (got last year). Concurrent medical conditions included ileo-anal pouch (J pouch) and colon cancer.   On 11th September 2020, the patient received the 1st dose of Shingrix and Influenza vaccine Quadrivalent 2020-2021 season. On 24th November 2020, 74 days after receiving Shingrix and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced pain and weakness. On an unknown date, the patient experienced pain in arm, weakness of arms and extremities hot feeling of. On an unknown date, the outcome of the pain in arm and weakness of arms were not recovered/not resolved and the outcome of the extremities hot feeling of was recovered/resolved and the outcome of the pain and weakness were unknown.   It was unknown if the reporter considered the pain in arm, weakness of arms, extremities hot feeling of, pain and weakness to be related to Shingrix. It was unknown if the reporter considered the pain and weakness to be related to Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient received 1st dose of Shingrix in her right arm deltoid and a flu shot at the same time in her left arm deltoid. The patient reported right arm sore and hot for 3 days then resolved. The patient reported continued weakness and pain in right arm. The patient does arm exercise reps at the gym with 10 to 12 pound weights and did so last night. On 24th November 2020, the patient was in a lot of pain. The patient stated that the pain and weakness were worse during lateral movements or when she raises her arm above her head. The reporter did not consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Neuropathy peripheral
Clinical narrative: Neuropathy / is going to receive Shingrix´s 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of neuropathy in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced neuropathy (serious criteria GSK medically significant). The patient was treated with immunoglobulin human normal (Gammagard). On an unknown date, the outcome of the neuropathy was not recovered/not resolved.   It was unknown if the reporter considered the neuropathy to be related to Shingrix.  Additional information was provided as follows: The reporter stated that a patient who was currently receiving Gammagard because of a neuropathy and the patient was going to receive Shingrix 2nd dose. No other information about the patient´s medical condition was provided and did not have any vaccine information. The reporter consented to follow up. No further information was available.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate increased
Clinical narrative: After the vaccine was administered, she decided to check her pulse and see that was a little high, get scared.  She was evaluated by the Fire Rescue at 10:30 am and was released home at 10:45 am.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pruritus, Injection site rash, Injection site warmth, Rash erythematous
Clinical narrative: Large local red rash at the injection site. Hot to the touch, very itchy. Applied cortisone topical and took PO Benadryl  for a few days. The rash started to improve after three days of taking Benadryl.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site pain, Nausea, Pain
Clinical narrative: Nausea  Body aches Fatigue Headache Injection site soreness
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Muscle soreness in left arm, fever at 99.6 degrees starting 6 hours after injection. Fever went to 100.5 degrees at 1am, 11 hours after injection, and stayed at over 100 degrees  until 6:30am, (100.4) when I took Tylenol as recommended by the nurse who administered the injection.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Injection site pain
Clinical narrative: Headache, nausea, vomiting, dizziness, body aches, pain at injection site, chills,fatigue
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Headache, nausea, vomiting, dizziness, body aches, pain at injection site, chills,fatigue
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Pain, Pyrexia
Clinical narrative: I felt close to passing out as my first  symptom after receiving the booster.  Since I had not heard this as a reaction, I thought I should report it.  I felt faint numerous times up to 90 hours afterward.  Then complete resolution.  I also had 101 fever for 24 hours, chills, body aches, but these symptoms have been listed as common.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: Muscle/joint aches, low grade fever, chills happens every 4 hours.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: After the vaccine, the wife verbalized her husband felt lightheaded and dizzy.  He was evaluated by Fire Rescue and released home at 2:32 pm.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Nausea, Pyrexia
Clinical narrative: I developed headache, low grade fever, and nausea at approximately 11:59 PM 1/11/2021. As of 05:42 AM 1/12/2021 these symptoms persist. Headache reduced via ibuprofen, fever and nausea did not respond.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nightmare, Pain
Clinical narrative: Uncontrollable chills, achiness, headache, nightmares
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Headache, Injection site pain, Nausea
Clinical narrative: Nausea, headache, vomiting, chills, body aches, pain at injection, dizzy
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vomiting
Clinical narrative: Nausea, headache, vomiting, chills, body aches, pain at injection, dizzy
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain
Clinical narrative: I had body aches, headaches, and just felt tired. I took Tylenol extra strength every 6 hours for a 24 hour period. After that I felt fine.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Nausea, Pyrexia
Clinical narrative: Fever, shortness of breath, nausea
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Insomnia, Pain in extremity, Peripheral swelling
Clinical narrative: Can barely move her arm / Difficult to raise her arm; Cannot sleep at night because of the pain; quite painful /  aches at night/SORENESS IN THE LEFT ARM/Soreness in the left arm / "it puts me over the floor"; Swollen in the arm muscle halfway between the elbow and shoulder; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix. On 20th October 2020, 1 days after receiving Shingrix, the patient experienced pain in arm and swelling arm. On an unknown date, the patient experienced injected limb mobility decreased and sleeplessness. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the pain in arm, injected limb mobility decreased, swelling arm and sleeplessness were not recovered/not resolved.   It was unknown if the reporter considered the pain in arm, injected limb mobility decreased, swelling arm and sleeplessness to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose pretty high in her left arm. The patient stated that the lot number and expiration date of vaccine were not available. The patient experienced soreness in the left arm and difficult to raise her arm.  The patient still had swelling, aches at night and could barely move her arm (moving her arm would cause it to ache more). The patient reported, she could not sleep at night because of the pain and it puts her over the floor. The patient described that the pain was not at the injection site and it was swollen in the arm muscle halfway between the elbow and shoulder of the left arm. The patient reported a pain medication was prescribed but it did not help at all and the pain has not resolved.  The patient gave permission to follow up with her doctor. This case had been linked with US2020231854, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020231854:same reporter US-GLAXOSMITHKLINE-US2020239794:Same reporter. From FU1 deleted
Sex: F
Vaccine: FLUX
Symptoms: Anaphylactic reaction
Clinical narrative: anaphylactic reaction to an influenza vaccine; Initial information regarding an unsolicited valid serious case was received from a consumer/non-health care professional (Reference number- 00416355) and transmitted to Sanofi on 05-Jan-2021.  This case involves female patient of an unknown age who experienced anaphylactic reaction, while she received INFLUENZA VACCINE.  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a serious anaphylactic reaction, (unknown latency) following the administration of INFLUENZA VACCINE. This event was assessed as medically significant.  Reporter was told that the reaction was due to the egg content and informed about components of Flublok.  Details of laboratory data not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.  Information on the batch number was requested.; Sender's Comments: This case concerns female patient of an unknown age who had anaphylactic reaction, after vaccination with INFLUENZA VACCINE (unknown manufacturer). The time to onset is unknown. The patent has a history of egg allergy. Additional information regarding patient's medical history, condition at the time of vaccination, lab data excluding other etiologies would be needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.