chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Nausea, Pain, Pyrexia, Vaccination site pain
Clinical narrative: not feel well; headache; nauseous; fever-elevated temperature; fatigue; body aches; her arm was sore after receiving the vaccine; daughter also felt very anxious; Felt like she had the flu; she experienced flu like symptoms; This is a spontaneous report from a contactable consumer or other non hcp.    A 37-years-old female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection (Batch/Lot Number: EN6200), dose 1 via an unspecified route of administration on 23Feb2021 as 1st dose, single for covid-19 immunisation. Medical history included ongoing tobacco user, covid-19 from an COVID-19 symptoms started on 08Dec2020, she tested positive for COVID on 10Dec2020. Concomitant medication(s) included ascorbic acid (VIT-C); ergocalciferol (VIT D). The patient previously took Lexapro for anxiety. It was reported that, The patient experienced she experienced flu like symptoms on 23Feb2021 with outcome of unknown, nauseous on 24Feb2021 with outcome of recovered , body aches on 23Feb2021 with outcome of recovered , fever-elevated temperature on 24Feb2021 with outcome of recovered , fatigue on 24Feb2021 with outcome of unknown , not feel well on an unspecified date with outcome of unknown , headache on 24Feb2021 with outcome of recovered , her arm was sore after receiving the vaccine on 23Feb2021 with outcome of unknown , daughter also felt very anxious on 23Feb2021 with outcome of unknown , felt like she had the flu on 23Feb2021 with outcome of recovered.  The patient underwent lab tests and procedures which included covid-19: positive on 10Dec2020.   No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Tinnitus
Clinical narrative: ringing in ears/tinnitus; they did it wrong, states that she had bruising because the person giving it to her was standing instead of sitting; This is a spontaneous report from a contactable consumer (patient).  A 49-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via unknown route at deltoid right on 19Feb2021 at 13:20 (lot number: EN6201) (age at vaccination 49-year-old) as dose 2, single for COVID-19 immunisation in hospital. The patient medical history included non-alcoholic fatty liver, obesity, restless leg syndrome, arthritis, chronic ear infections (as a kid), scarring, two sets of tubes put in and once a ruptured ear drum from an unknown date and ongoing. The patient received flu vaccine on 08Jan2021 within four weeks prior to the first administration date of the suspect vaccine. List all vaccines administered on same date with the Pfizer vaccine considered as suspect was reported as none. The patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via unknown route at arm right on 22Jan2021 around 09:00 in the morning (lot number: EL8982) (age at vaccination 49-year-old) as dose 1, single for COVID-19 immunisation. The patient concomitant medications included for mirapex for restless leg syndrome since years and voltaren for arthritis maybe from 4 months ago. The patient family medical history relevant to adverse events and relevant tests was none. The patient had experienced ringing in ears/tinnitus and they did it wrong, states that she had bruising because the person giving it to her was standing instead of sitting. The patient did not required to attend the physician office and emergency room. Treatment received was reported as none. The outcome of the event ringing in ears/tinnitus was not recovered and the event bruising was recovered on an unknown date.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Fatigue, Feeling of body temperature change, Headache, Increased upper airway secretion
Clinical narrative: a lot of mucus in her nose/constantly blowing nose/mucous coming out; phlegm in nose/a lot of flem/flem was beige; mucous in her throat with beige black spots; headache; feels like a flu; coughing a lot; feeling "tired, and cold and hot".; feeling "tired, and cold and hot".; This is a spontaneous report from a contactable consumer (patient). The reporter also reports on her husband and her mother and husband's brother.   A 65-year-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration and NDC number date was not reported), via an unspecified route of administration on 01Mar2021 as dose 1, single (at the age of 65-year-old) for COVID-19 immunisation. Medical history included spinal fusion (last year) from 2020 to an unknown date. The family history included husband was diabetic, has heart problems, Chronic Obstructive Pulmonary disease (COPD), and overweight. Historical vaccine included patient received flu shot (Influenza vaccine) (54 when she had to get the flu shot) on an unknown date for immunisation. The patient's concomitant medications were not reported. Patient was not a sickly person. On Mar2021, a week later, patient had chills, mucous coming out/a lot of mucus in her nose, phlegm in nose/phlegm in nose/a lot of flem/flem was beige and still has it, mucous in her throat with beige black spots, feeling tired, and cold and hot.  Patient adds that she has not had any chills.  On an unspecified date of 2021, patient had a headache, was probably coughing and feels like a flu. Phlegm was still coming out, mucous was still there. Patient was constantly blowing her nose and constantly hacking mucous. Patient does not have a primary care doctor, she does not go around, she keeps her mask on, and stays in the house. Patient adds that she thinks the thing was that she was scheduled to see her neurosurgeon today (19Mar2021), this morning but was going to cancel because even if this was a cold she does not want to go in there or give anybody anything.  Patient adds that she does not have a fever, she just does not know.  Patient talked to the secretary at the physician's office and did not want to go there and give them anything. Patient was scheduled for her second vaccination dose on Monday (22Mar2021) and she hopes that nobody tells her not to go because that means that her first dose will not work and she would have to start all over again. Patient adds that she would like to speak to somebody about if she should take the second vaccine. She adds it took her 50 years to get her flu shot, she was 54 when she had to get the flu shot. She did not want something to happen to her and then her family will not take the vaccine.  She just wanted to know if something happens to her. The outcome of phlegm in nose/a lot of flem/flem was beige was not recovered and unknown for rest of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Productive cough, Rhinorrhoea
Clinical narrative: a lot of mucus in her nose/constantly blowing nose/mucous coming out; phlegm in nose/a lot of flem/flem was beige; mucous in her throat with beige black spots; headache; feels like a flu; coughing a lot; feeling "tired, and cold and hot".; feeling "tired, and cold and hot".; This is a spontaneous report from a contactable consumer (patient). The reporter also reports on her husband and her mother and husband's brother.   A 65-year-old female patient received BNT162b2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number, Expiration and NDC number date was not reported), via an unspecified route of administration on 01Mar2021 as dose 1, single (at the age of 65-year-old) for COVID-19 immunisation. Medical history included spinal fusion (last year) from 2020 to an unknown date. The family history included husband was diabetic, has heart problems, Chronic Obstructive Pulmonary disease (COPD), and overweight. Historical vaccine included patient received flu shot (Influenza vaccine) (54 when she had to get the flu shot) on an unknown date for immunisation. The patient's concomitant medications were not reported. Patient was not a sickly person. On Mar2021, a week later, patient had chills, mucous coming out/a lot of mucus in her nose, phlegm in nose/phlegm in nose/a lot of flem/flem was beige and still has it, mucous in her throat with beige black spots, feeling tired, and cold and hot.  Patient adds that she has not had any chills.  On an unspecified date of 2021, patient had a headache, was probably coughing and feels like a flu. Phlegm was still coming out, mucous was still there. Patient was constantly blowing her nose and constantly hacking mucous. Patient does not have a primary care doctor, she does not go around, she keeps her mask on, and stays in the house. Patient adds that she thinks the thing was that she was scheduled to see her neurosurgeon today (19Mar2021), this morning but was going to cancel because even if this was a cold she does not want to go in there or give anybody anything.  Patient adds that she does not have a fever, she just does not know.  Patient talked to the secretary at the physician's office and did not want to go there and give them anything. Patient was scheduled for her second vaccination dose on Monday (22Mar2021) and she hopes that nobody tells her not to go because that means that her first dose will not work and she would have to start all over again. Patient adds that she would like to speak to somebody about if she should take the second vaccine. She adds it took her 50 years to get her flu shot, she was 54 when she had to get the flu shot. She did not want something to happen to her and then her family will not take the vaccine.  She just wanted to know if something happens to her. The outcome of phlegm in nose/a lot of flem/flem was beige was not recovered and unknown for rest of the events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Mass, Vaccination site induration, Vaccination site pain, Vaccination site swelling
Clinical narrative: I have a large bump on my arm from my 2nd civic vaccination; Injection site is still hard and swollen and pain all way; Injection site is still hard and swollen and pain all way/pain running all the way down to my finger tips.; Injection site is still hard and swollen and pain all way; This is a spontaneous report from a contactable consumer or other non hcp (patient) received from a Pfizer.com-General Company Information (CEP ID 3110). A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on an unspecified date at dose 1, single for covid-19 immunisation. Medical history and concomitant medications were not reported. On an unspecified date customer Verbatim: I have a large bump on my arm from my 2nd civic vaccination and pain running all the way down to my finger tips. Started shortly after injection and on day 4 sti the same. Injection site is still hard and swollen and pain all way down. Please advise. Cannot find any info on this anywhere. Outcome of the events was unknown.  Information on the lot/batch number has been requested.  Follow-up (13May2021): Follow-up attempts completed. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: covered in hives/ broke out in hives everywhere/hives developed the same day that the vaccine was given; This is a spontaneous report from a contactable consumer (patient). A 69-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EN6198, Expiration date not reported), via an unspecified route of administration on 26Feb2021 (at the age of 69 years old) as dose 1, single for COVID-19 immunization. The patient medical history included hands stinging and burning on 25Feb2021, on Thursday night (night before getting 1st dose of vaccine). Patient had no other medical history and received no concomitant medications. On 26Feb2021, same day after taking vaccine, the patient was covered in hives/broke out in hives everywhere. It was reported that, patient went to the emergency room and with the hives she did not think she got hives from the shot because she had the feeling coming on her hands that night before. Patient received treatment with steroids for the hives. At the time of reporting, the hives were gone and did not appear at all, but patient had to take steroids. Patient reported that, the doctor at the ER told her they didn't think it was from the shot itself, but she was concerned if she should take that next shot on 20Mar2021. The outcome of event was resolved on an unknown date in 2021.  No follow-up attempts are needed. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: had a little rashes in her lower eye that going to her cheek; This is a spontaneous report from a contactable consumer (patient). This is a report received from a Pfizer-sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported), via an unspecified route of administration on 18Feb2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient informed that she was fine after the 1st dose of the vaccine last 18Feb2021 and was scheduled for the 2nd dose tomorrow 11Mar2021. On an unspecified date, the patient experienced had a little rashes in her lower eye that going to her cheek. Outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Body temperature, Cough, Diarrhoea, Dyspnoea
Clinical narrative: Fever; Fatigue; Abdominal cramps; Diarrhoea; Sweating; shortness of breath came with the cough; shortness of breath came with the cough; elevated heart rate; cramping; This is a spontaneous report from a contactable consumer or other non-HCP.   A 73-years-old female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EN6203) via intramuscular route of administration on 03Mar2021, as a single dose for COVID-19 immunization. The patient's relevant medical history included Parkinsons disease and Generic of Parcopa from an unspecified date. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced Fever, Fatigue, Abdominal cramps, Diarrhoea, Sweating, shortness of breath came with the cough and elevated heart rate. Additional Information: The reporter stated that she was actually calling about for husband. Well, the debate was the reporter wanted to get some advice about husband getting the second dose of the Pfizer vaccine for the COVID-19. She confirmed that it was the Covid19 vaccine of Pfizer. When probed for side effects, she stated that yes, began on the second day from the vaccine, the husband experienced fever, fatigue, abdominal cramps, diarrhea, sweating and also he had cough. Associated with the cough, had shortness of breath. He was sitting and not coughing he was okay, but the shortness of breath came with the cough. Also, he had somewhat elevated heart rate, it was not over a 100 but it was around 99 to a 100 and she did mentioned that, he had a fever right. She stated that he did not had any treatment. She stated that expiration date was not listed on their card. It just list the day that they received it but it did not have an expiration. She also stated that they did went and had the COVID-19 test, the nose swab that was negative. The patient underwent lab tests and medical procedures on an unspecified date which included Body temperature with unknown results and Covid-19 Nasal Swab Test which showed negative result. The clinical outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. .
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Heart rate increased, Hyperhidrosis, Muscle discomfort, Pyrexia
Clinical narrative: Fever; Fatigue; Abdominal cramps; Diarrhoea; Sweating; shortness of breath came with the cough; shortness of breath came with the cough; elevated heart rate; cramping; This is a spontaneous report from a contactable consumer or other non-HCP.   A 73-years-old female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EN6203) via intramuscular route of administration on 03Mar2021, as a single dose for COVID-19 immunization. The patient's relevant medical history included Parkinsons disease and Generic of Parcopa from an unspecified date. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced Fever, Fatigue, Abdominal cramps, Diarrhoea, Sweating, shortness of breath came with the cough and elevated heart rate. Additional Information: The reporter stated that she was actually calling about for husband. Well, the debate was the reporter wanted to get some advice about husband getting the second dose of the Pfizer vaccine for the COVID-19. She confirmed that it was the Covid19 vaccine of Pfizer. When probed for side effects, she stated that yes, began on the second day from the vaccine, the husband experienced fever, fatigue, abdominal cramps, diarrhea, sweating and also he had cough. Associated with the cough, had shortness of breath. He was sitting and not coughing he was okay, but the shortness of breath came with the cough. Also, he had somewhat elevated heart rate, it was not over a 100 but it was around 99 to a 100 and she did mentioned that, he had a fever right. She stated that he did not had any treatment. She stated that expiration date was not listed on their card. It just list the day that they received it but it did not have an expiration. She also stated that they did went and had the COVID-19 test, the nose swab that was negative. The patient underwent lab tests and medical procedures on an unspecified date which included Body temperature with unknown results and Covid-19 Nasal Swab Test which showed negative result. The clinical outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. .
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Fever; Fatigue; Abdominal cramps; Diarrhoea; Sweating; shortness of breath came with the cough; shortness of breath came with the cough; elevated heart rate; cramping; This is a spontaneous report from a contactable consumer or other non-HCP.   A 73-years-old female received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was EN6203) via intramuscular route of administration on 03Mar2021, as a single dose for COVID-19 immunization. The patient's relevant medical history included Parkinsons disease and Generic of Parcopa from an unspecified date. The patient's concomitant medications were not reported. On an unspecified date, the patient experienced Fever, Fatigue, Abdominal cramps, Diarrhoea, Sweating, shortness of breath came with the cough and elevated heart rate. Additional Information: The reporter stated that she was actually calling about for husband. Well, the debate was the reporter wanted to get some advice about husband getting the second dose of the Pfizer vaccine for the COVID-19. She confirmed that it was the Covid19 vaccine of Pfizer. When probed for side effects, she stated that yes, began on the second day from the vaccine, the husband experienced fever, fatigue, abdominal cramps, diarrhea, sweating and also he had cough. Associated with the cough, had shortness of breath. He was sitting and not coughing he was okay, but the shortness of breath came with the cough. Also, he had somewhat elevated heart rate, it was not over a 100 but it was around 99 to a 100 and she did mentioned that, he had a fever right. She stated that he did not had any treatment. She stated that expiration date was not listed on their card. It just list the day that they received it but it did not have an expiration. She also stated that they did went and had the COVID-19 test, the nose swab that was negative. The patient underwent lab tests and medical procedures on an unspecified date which included Body temperature with unknown results and Covid-19 Nasal Swab Test which showed negative result. The clinical outcome of all the events was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. .
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pain
Clinical narrative: Body pain; Joint pain; This is a spontaneous report from a contactable consumer (patient) via the Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (lot number and expiry date: unknown) as dose 1, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, after first dose, the patient experienced body pain and joint pain. She was scheduled for the second dose today however she's was still experiencing the body pain. She then asked if she needs time or if she needs to consult a dose for today. Outcome of the event body pain was not recovered, while for joint pain was unknown.  No follow-up attempts are possible; information on lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache
Clinical narrative: headaches; fatigue; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation; tofacitinib citrate (XELJANZ XR), via an unspecified route of administration from an unspecified date at 11 mg for an unspecified indication. The patient medical history and concomitant medications were not reported. During inbound call from the patient, the patient stated "I just got the COVID vaccine but I've been having headaches and fatigue". During inbound call from the patient, the patient has medical inquiry: If she should take the Xeljanz medication after getting the COVID-19 Vaccine. The action taken in response to the events for tofacitinib citrate was unknown. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Pyrexia
Clinical narrative: fatigue; Very low grade fever 99.8; headache; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection; Batch/Lot Number, and Expiration Date not reported) via an unspecified route of administration on an unspecified date, as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced fatigue, very low grade fever 99.8, and headache on an unspecified date. It was reported that the events took place after use of product. The patient underwent lab tests and procedures which included body temperature: 99.8 fahrenheit on an unspecified date. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia, Vaccination site discomfort
Clinical narrative: Approximately 12 hours after 2nd dose, I developed the chills; Approximately 12 hours after 2nd dose, I developed the chills and a 101.8 temperature; had discomfort at the injections site; This is a spontaneous report from a contactable consumer (Patient).  A 42-years-old male patient received second dose of bnt162b2 (BNT162B2, solution for injection; Batch/Lot Number: EL3248), dose 2 via an unspecified route of administration, administered in Arm Left on 16Mar2021 10:30 as dose 2, single (At the age of 42-years) for covid-19 immunisation. Historical vaccine included received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/Lot Number: EL3247), via an unspecified route of administration, administered in Arm Left on 24Feb2021 11:00 (at the age of 42-years-old) as single for COVID-19 immunization. Medical history was reported as none. Allergies to medications, food, or other products were reported as none. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication(s) included amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL) taken for an unspecified indication, start and stop date were not reported and Rainbow Light Mens One multivitamin. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 16Mar2021 22:00 approximately 12 hours after 2nd dose, the patient developed the chills and a 101.8 temperature, had discomfort at the injections site. Since the vaccination, the patient was not tested for COVID-19. On 16Mar2021 the patient underwent lab tests and procedures which included body temperature: 101.8. The patient did not receive any treatment for the events. The outcome of the events was recovering.   Follow up #1(PRD 20Mar2021) This is a follow up spontaneous report in response to mail trail sent regarding the confirmation of below mentioned query. This reported included that.  The awareness date was 16Mar21.  No follow-up attempts are needed. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Pain, Swelling
Clinical narrative: sore underarm; swelling; mild aches; This is a spontaneous report from a contactable Nurse (patient) reported for herself. A 57-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection and Lot Number: EN6203) via an unspecified route of administration, administered in right arm on 10Mar2021 15:00 (at the age of 57-years-old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included escitalopram oxalate (LEXAPRO) and Multivitamin taken for an unspecified indication, start and stop date were not reported. Patient previously took first dose of BNT162B2 (at the age of 57-years-old) (lot number: EL3247, vaccine location: Left arm) on 19Feb2021 23:45 for covid-19 immunisation. The patient had no known allergies. It was reported that on 11Mar2021 07:00 the patient woke up with a sore underarm the next morning after receiving second dose vaccination. When looking in the mirror, it was noted a swelling. The event went away in 3 days. She also had mild aches but took 3 advil and felt good. The patient did not received treatment for the events. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Patient did not receive any other vaccines within 4 weeks to the COVID vaccine. The outcome of all the events was recovered on an unspecified date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia
Clinical narrative: her muscles and joints hurt like hell/Muscles and joints hurt; her muscles and joints hurt like hell/ Muscles and joints hurt; head pounding, later confirmed as headache/Heading pounding, headache; This is a spontaneous report from a contactable consumer (patient). A 75-year-old female patient received second dose of bnt162b2 (PFIZER-BIOINTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EN6205) via unknown route of administration on 16Mar2021 (at the age of 75 years old) as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history included arthritis (from unknown date and ongoing), pain, anxiety and depression (from unknown date and unknown if ongoing). The concomitant medication included clonazepam (KLONOPIN) 1 mg at night once a day and fluoxetine hydrochloride (PROZAC) 20 mg at night once a day with ongoing for anxiety and depression and ongoing diclofenac (VOLTAREN) apply on legs and bottom of feet for pain. The patient historical vaccine included first dose of bnt162b2 PFIZER-BIOINTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number: EN6205, Expiration Date: 30Jun2021) via unknown route of administration in Left top of shoulder on 23Feb2021 (at the age of 75 years old) as DOSE 1, SINGLE for covid-19 immunisation. The patient received B12 shots every month prior Vaccinations within 4 weeks. No additional vaccines administered on same date of the Pfizer vaccine. She got her second dose yesterday (16Mar2021) and on 17Mar2021, this morning she woke up with her head pounding, later confirmed as headache, and her muscles and joints hurt like hell. The patient did not visit emergency room and physician office due to the events. At the time of this report the outcome of the event was not recovered.  No follow-up attempts were possible. No further information was expected.
Age: 88.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion, Pain in extremity, Rash erythematous, Skin reaction
Clinical narrative: little red dots about 4 inch wide; skin reaction.; bruising on the arm from shoulder to outer arm and biceps; arm soreness; This is a spontaneous report from a contactable consumer or other non-Health Care Professional. A 88-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number : EN6199 and Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Left on 09Mar2021 as DOSE 1, SINGLE for covid-19 immunization. Medical history included , ongoing hypersensitivity Verbatim: X-Ray Dye , ongoing dust allergy Verbatim: Dust , ongoing dyspnoea Verbatim: Breathing problems , ongoing atrial fibrillation Verbatim: A-Fib , ongoing asthma Verbatim: Asthma , ongoing diabetes mellitus Verbatim: Diabetes , ongoing implantable defibrillator insertion Verbatim: has a defibrillator , neoplasm malignant from an unknown date and unknown if ongoing Verbatim: Cancer , ongoing hypersensitivity. There is no vaccinations Prior Vaccinations within 4 weeks, mentioned patient gets a shot in his hip due to have Stage IV Cancer. He gets this shot every six months. The last time was 03Mar2021, it is a hormone shot. Concomitant medication included folic acid taken for cardiac arrest from an unspecified start date and ongoing; carvedilol taken for cardiac disorder from an unspecified start date and ongoing; digoxin taken for cardiac disorder from an unspecified start date and ongoing; metolazone taken for fluid retention from an unspecified start date and ongoing; acetylsalicylic acid (ASPIRIN (E.C.)) taken for an unspecified indication from an unspecified start date and ongoing; sertraline; potassium taken for an unspecified indication from an unspecified start date and ongoing; gabapentin (GABAPENTIN) taken for restless legs syndrome from an unspecified start date and ongoing; losartan taken for cardiac disorder from an unspecified start date and ongoing; warfarin; niacin taken for an unspecified indication from an unspecified start date and ongoing; insulin (INSULIN) taken for an unspecified indication from Mar2021 to Mar2021; ammonium lactate taken for dry skin from an unspecified start date and ongoing; ketoconazole; magnesium ;ascorbic acid (VIT-C); calcium citrate ; mometasone furoate taken for an unspecified indication from an unspecified start date and ongoing; mometasone furoate (ASMANEX) taken for asthma from an unspecified start date and ongoing; torsemide; cholecalciferol (VIT D3) taken for an unspecified indication, start and stop date were not reported.The patient previously took tramadol and experienced hypersensitivity. On 09Mar2021 the patient experienced arm soreness. on 15Mar2021 the patient experienced bruising on the arm from shoulder to outer arm and biceps. on an unspecified date the patient experienced little red dots about 4 inch wide, skin reaction. The outcome of event was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Myalgia, Skin discolouration
Clinical narrative: muscle is still a little tender in that spot; It is black and blue; developed a large bruise on left arm; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 76-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Lot number :EN6200 and Expiration date:30Jun2021), via an unspecified route of administration, administered in left arm on 24Feb2021 13:30 (at the age of  vaccination 76-year-old) as dose 1, single for covid-19 immunization. The second dose was scheduled for 24Mar2021. Medical history included gastrooesophageal reflux disease from an unknown date and unknown if ongoing. Concomitant medication(s) included metoprolol, aspirin , rosuvastatin taken for anticoagulant therapy , famotidine taken for gastrooesophageal reflux disease Aug2020 to an unspecified stop date, ticagrelor taken for anticoagulant therapy, start and stop date were not reported. The patient did not take additional vaccine on same date or within 4 weeks. On 26Feb2021, the patient reported that within 2 days of first dose she developed a large bruise on left arm and tenderness, was concerned about it because it was still there. It is two inches down from where the injection went in and also looks like somebody punched her in the arm. The patient does not know if bruise is because of the Brilinta. She knows she did not bruise herself by bumping her arm. On an unspecified date, the  patient had the muscle was still a little tender in that spot. It was black and blue. The mark was still there when she rubs her arm. Bruise was still visually there. Bruise had improved. It was fading, but still there and visible. The outcome of event Bruise and Skin discolouration were recovering, while the outcome of the event Muscle pain was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Gingival discomfort, Gingival swelling, Mastication disorder, Pain
Clinical narrative: Discomfort in my gums they kind of like swollen; Discomfort in my gums they kind of like swollen; Its still painful, its still hard to chew and eat; Its still painful, its still hard to chew and eat; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (PFIZER BIONTECH COVID-19 MRNA VACCINE Solution for injection Lot number was not reported) via an unspecified route of administration on an unspecified date as dose number unknown, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced discomfort in my gums they kind of like swollen. Its still painful, its still hard to chew and eat. It was reported that got my Pfizer shot last Wednesday and may be Thursday, Friday, started feeling like discomfort in my gums they kind of like swollen. So thats why calling you up. So, they got swollen and its still painful, its not as painful as it was Saturday but its still hard to chew and eat so I dont know if that was the side effect of the vaccine or something I need to check out with my dentist to do something because its on both sides. The clinical outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea, Pyrexia, Vertigo
Clinical narrative: About 3:30 am woke up with headache; slight fever; nauseous; Dizziness/vertigo; Dizziness/vertigo; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 61-years-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection) via an unspecified route of administration on 24Feb2021 at 15:00 pm (Batch/Lot Number: e19265) as dose number unknown, single for covid-19 immunization (at the age of 61-years-old). Medical history included stiff person syndrome, myasthenia gravis, Sjogren's, antiphospholipid protein syndrome, hashimoto's, autonomic dysfunction and chronic lymphocytic leukemia stage, all were from an unknown date and unknown if ongoing. Concomitant medication(s) included aspirin [acetylsalicylic acid]; liothyronine sodium (CYTOMEL); diazepam (VALIUM) and levothyroxine sodium (SYNTHROID) taken for an unspecified indication, start and stop date were not reported. The patient previously took propranolol and experienced allergy. Facility where the most recent Covid-19 vaccine was administered was reported as other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with Covid-19. Since the vaccination, the patient has not been tested for Covid-19. It was reported by the patient that on 24Feb2021 at 15:00 pm she received the first dose of vaccine and on 25Feb2021 about 3:30 am she woke up with headache, slight fever, nauseous and dizziness/vertigo. She mentioned that she got dizzy 12 hours after the covid vaccine. She further mentioned that by the morning, everything went away except for vertigo sometimes slight, sometimes more intense. It never lasted a really last time, but it was still happening. The events resulted in doctor or other healthcare professional office/clinic visit. Patient did not receive any treatment for the events. The patient was not recovered from the event of vertigo and was recovered form rest of all other events in Feb2021.   No follow-up attempts are needed. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Pyrexia, Vaccination site pain
Clinical narrative: moderate pain on the injection site; feverish; feeling unwell; tiredness; This is a spontaneous report received from a contactable other healthcare professional (patient). A 55-years-old male patient received BNT162B2 (Pfizer-BioNTech Covid-19 mRNA Vaccine, Solution for injection, Batch/Lot number: EL3247 and Expiration date was not reported), via an unspecified route of administration, administered in left arm on 15Mar2021 at 13:45 hours as dose number unknown, single (at the age of 55-years-old) for COVID-19 immunisation. Medical history included hypertension and hyperlipidaemia (both from an unknown date and unknown if ongoing). Concomitant medication(s) within 2 weeks of vaccination included nebivolol hydrochloride (Bystolic) and atorvastatin (both taken for an unspecified indication, start and stop date were not reported). Patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Patient was not diagnosed with COVID-19, prior to vaccination and had not been tested for COVID-19, since the vaccination. Patient had no known allergies to medications, food, or other products. On 16Mar2021, patient experienced moderate pain on the injection site; feverish, feeling unwell and tiredness. Patient received no treatment received for all the events. The outcome of all the events was recovering.  No follow-up attempts are needed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Body temperature, Headache, Neck pain
Clinical narrative: Temperature of 100.4; Headache; Neck pain; back pain; pain with shoulder blades; Tenderness in arm; This is a spontaneous report from a contactable consumer(patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Deltoid Left on 04Mar2021 (Batch/Lot Number: EN6205) as Dose 1,Single for COVID-19 immunization. Medical history included Type II diabetic, Adult Asthma. Concomitant Medications included she takes a lot of medications, but does not feel like she needs to list them.  Historical vaccine included for flu shot INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED). No Prior Vaccinations taken within 4 weeks. The patient experienced tenderness in arm on 05Mar2021, headache, neck pain, back pain, pain with shoulder blades on 10Mar2021, temperature of 100.4 on 10Mar2021 17:00.  The patient underwent lab tests and procedures which included body temperature: 100.4 on 10Mar2021. Therapeutic measures were taken. Outcome of the events was tenderness in arm, headache, temperature of 100.4 was recovered on Mar2021.Outcome of the events neck pain, back pain, pain with shoulder blades was recovering.  No follow up attempts are possible. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Temperature of 100.4; Headache; Neck pain; back pain; pain with shoulder blades; Tenderness in arm; This is a spontaneous report from a contactable consumer(patient). A 61-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Deltoid Left on 04Mar2021 (Batch/Lot Number: EN6205) as Dose 1,Single for COVID-19 immunization. Medical history included Type II diabetic, Adult Asthma. Concomitant Medications included she takes a lot of medications, but does not feel like she needs to list them.  Historical vaccine included for flu shot INFLUENZA VACCINE (SPLIT VIRION, INACTIVATED). No Prior Vaccinations taken within 4 weeks. The patient experienced tenderness in arm on 05Mar2021, headache, neck pain, back pain, pain with shoulder blades on 10Mar2021, temperature of 100.4 on 10Mar2021 17:00.  The patient underwent lab tests and procedures which included body temperature: 100.4 on 10Mar2021. Therapeutic measures were taken. Outcome of the events was tenderness in arm, headache, temperature of 100.4 was recovered on Mar2021.Outcome of the events neck pain, back pain, pain with shoulder blades was recovering.  No follow up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Body temperature decreased, Discomfort, Headache
Clinical narrative: low temperature; headache; pain around the left arm injection site; pain/discomfort to her whole body including arms, legs, and feet; pain/discomfort to her whole body including arms, legs, and feet; generalized joint pain; This is a spontaneous report from a contactable consumer. This 77-year-old female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP7534), via an unspecified route of administration on 17Mar2021 11:30 (at the age of 77-year-old) at dose 1, single in left arm for COVID-19 immunisation. Medical history included COVID (2.5 months ago), broke her back in Jul2020, stroke in Jan1997 (takes aspirin 325 mg each day), mold allergy, grass allergy and iodine allergy. The concomitant medication included warfarin sodium (COUMADIN SODIUM). The patient previously received penicillin. It was reported that she received first Pfizer Covid vaccine dose on 17Mar2021. Since start of therapy (17Mar2021), she experienced headache, pain around the left arm injection site, and pain/discomfort to her whole body including arms, legs, and feet. Also reports generalized joint pain. She states she has had a stroke in Jan1997 and takes aspirin 325 mg each day. She reports her symptoms are improved but wants to know if she would be contagious after receiving the vaccine. The patient reports having the Covid virus and she reports her son had the Covid virus and continues to have a "rash" from the infection. She had her first shot yesterday, Pfizer Covid vaccine, states she thinks she came down with the flu now. She had the Covid about 2.5 months ago, came down with it new years day so her doctor made her wait for the vaccine since she had Covid before. She was fine when she got home yesterday, got shot at 11:30 AM, states around 7:30 PM and must have fallen asleep, when she woke up and her bones, had bad joint pain, feels much better today, has a low temperature, its down to 96.6. She broke her back in Jul2020 which is why she has gained some weight. She had a major stroke over 20 years ago, affected her right side so she got the shot in her left arm. She has a lot of allergies and is on coumadin- allergic to iodine big time, states it might kill her and also to penicillin, also to grass and mold. She has a problem with her stomach, and on medication but does not take it every day, no further information provided. All prior to vaccine. On 18Mar2021, the patient underwent lab test and procedure included body temperature: 96.6. Outcome of the events generalized joint pain and low temperature was not resolved and for other events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site pain
Clinical narrative: low temperature; headache; pain around the left arm injection site; pain/discomfort to her whole body including arms, legs, and feet; pain/discomfort to her whole body including arms, legs, and feet; generalized joint pain; This is a spontaneous report from a contactable consumer. This 77-year-old female consumer reported for herself that she received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EP7534), via an unspecified route of administration on 17Mar2021 11:30 (at the age of 77-year-old) at dose 1, single in left arm for COVID-19 immunisation. Medical history included COVID (2.5 months ago), broke her back in Jul2020, stroke in Jan1997 (takes aspirin 325 mg each day), mold allergy, grass allergy and iodine allergy. The concomitant medication included warfarin sodium (COUMADIN SODIUM). The patient previously received penicillin. It was reported that she received first Pfizer Covid vaccine dose on 17Mar2021. Since start of therapy (17Mar2021), she experienced headache, pain around the left arm injection site, and pain/discomfort to her whole body including arms, legs, and feet. Also reports generalized joint pain. She states she has had a stroke in Jan1997 and takes aspirin 325 mg each day. She reports her symptoms are improved but wants to know if she would be contagious after receiving the vaccine. The patient reports having the Covid virus and she reports her son had the Covid virus and continues to have a "rash" from the infection. She had her first shot yesterday, Pfizer Covid vaccine, states she thinks she came down with the flu now. She had the Covid about 2.5 months ago, came down with it new years day so her doctor made her wait for the vaccine since she had Covid before. She was fine when she got home yesterday, got shot at 11:30 AM, states around 7:30 PM and must have fallen asleep, when she woke up and her bones, had bad joint pain, feels much better today, has a low temperature, its down to 96.6. She broke her back in Jul2020 which is why she has gained some weight. She had a major stroke over 20 years ago, affected her right side so she got the shot in her left arm. She has a lot of allergies and is on coumadin- allergic to iodine big time, states it might kill her and also to penicillin, also to grass and mold. She has a problem with her stomach, and on medication but does not take it every day, no further information provided. All prior to vaccine. On 18Mar2021, the patient underwent lab test and procedure included body temperature: 96.6. Outcome of the events generalized joint pain and low temperature was not resolved and for other events was unknown.  No follow-up attempts are possible. No further information is expected.