chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain
Clinical narrative: she began experiencing neck and shoulder pain; she began experiencing neck and shoulder pain; This is a spontaneous report from a contactable consumer (Patient). A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot Number: Unknown, Expiration date: Unknown) via an unspecified route of administration in Right Arm on 02Jun2021 at 16:10 (Age at vaccination 43-year) as single dose for COVID-19 immunization. Medical history included gout from Jan2021 if ongoing. The patient's concomitant medications were not reported. The patient received first dose of BNT162B2(Batch/Lot Number: Unknown, Expiration date: Unknown) administered on 07May2021 13:30 in right shoulder for COVID-19 immunization. The patient states she took the vaccine for her mother because her mother is 72 and had kidney cancer. Patient states she lives at home with her mother. The patient also states her mother has arthritis and she has problems with degenerative discs in her back. On 06Jun2021 the patient reported she began experiencing neck and shoulder pain. The seriousness of the events was reported as non-serious. The clinical outcome of the events was not recovered.  Follow-up attempts are needed; information about lot/batch number is requested.
Sex: U
Vaccine: COVID19
Symptoms: Cystitis, Pain, Urinary tract infection
Clinical narrative: I have whole long UTI or bladder infection/Bladder or urinary infection; I have a full grown infection; It really hurts; I have whole long UTI or bladder infection/Bladder or urinary infection; I have a full grown infection; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 02Jun2021 as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took 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 as 1st dose, single dose for COVID-19 immunization. It was reported that the patient had second vaccination on 02Jun2021 and prior to that and during that time, patient had no urinary tract infection symptoms or bladder irritation of any kind and now had whole long urinary tract infection or bladder infection on an unspecified date in Jun2021. The patient wondering because now had a full-grown infection. The patient asked was that a side effect anyone had reported previously. The patient wanted to find out if that was associated. The patient stated that need to get taken care of because it really hurts. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Migraine, Pain, Pyrexia
Clinical narrative: 24 hours after injection I have gotten a 102F+ fever, uncontrollable body chills, body aches, horrible pounding migraine half a day for 2nd dose; 24 hours after injection I have gotten a 102F+ fever, uncontrollable body chills, body aches, horrible pounding migraine half a day for 2nd dose; 24 hours after injection I have gotten a 102F+ fever, uncontrollable body chills, body aches, horrible pounding migraine half a day for 2nd dose; 24 hours after injection I have gotten a 102F+ fever, uncontrollable body chills, body aches, horrible pounding migraine half a day for 2nd dose; This is a spontaneous report from a contactable consumer or other non hcp. A 35-years-old adult male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number:EW0168; Expiry date: unknown),via an unspecified route of administration, in the Left Arm on 15May2021 at 13:00 as a single dose for COVID-19 immunization. The patient's medical history included disability due to back injury and nerve damage in both legs. The patient reported No allergies. The patient's concomitant medications included buprenorphine (BUPRENORPHINE); oxycodone (OXYCODONE), etodolac (ETODOLAC); baclofen (BACLOFEN). The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19 since the vaccination. On 06Jun2021 at 12:00, the patient reported for both doses, 24 hours after injection I have gotten a 102F+ fever, uncontrollable body chills, body aches, horrible pounding migraine that lasted 2 days for 1st dose, and so far, half a day for 2nd dose. No treatment was received for the events. The clinical outcome for the events was not recovered/not resolved.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Bone marrow disorder, Fatigue, Headache
Clinical narrative: fever 104F/the second day her fever was 100-98 degrees; nausea; sweats; vertigo; arthritic joint pain; headache; skin irritation; bone marrow pain; tiredness after the first dose; body aches; This is a spontaneous report from a contactable consumer (patient).   A 67-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0182, Expiration date: unknown), dose 1 via an unspecified route of administration, administered in arm left on 18May2021 as 1st dose, single dose for COVID-19 immunization. Medical history included Covid infection in January that lasted approximately 3.5 weeks. The patient's concomitant medications included ongoing Vitamins. No history of all previous immunization with the Pfizer vaccine considered as suspect and no Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks. No relevant family history. On 19May2021 (Next day morning), the patient experienced 104 degree Fahrenheit fever, nausea, sweats, vertigo, arthritic joint pain, headache, skin irritation, bone marrow pain, body ache, tiredness because when she was sick tired, and she felt like she got the Covid all over again; and on 29May2021, the second day her fever was 100-98 degrees Fahrenheit. She reports that her symptoms post vaccination were mild compared to Covid infection and she was the only one she knows of that developed these symptoms post vaccination. Patient normal body temperature was reported as 97.7 degrees Fahrenheit. Skin irritation was explained as flashes of skin irritation where she didn't want anything to be touching her skin; her skin was irritated by clothes, sheets, and the floor. States her whole skin reacted. No visit to Emergency Room or Physician Office. Therapeutic measures were taken with 2 Tylenol. No relevant tests done. No Investigation Assessment. The patient underwent lab tests and procedures which included body temperature: 104 Fahrenheit on 19May2021, and 100-98 Fahrenheit on 20May2021. Patient reported she didn't have an allergic reaction. The outcome of event was recovered on 22May2021.  Follow up needed, further information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021669700 same reporter/ product, different patient.;US-PFIZER INC-2021667900 same reporter/ product, different patient.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Nausea, Pain, Pyrexia, Skin irritation
Clinical narrative: fever 104F/the second day her fever was 100-98 degrees; nausea; sweats; vertigo; arthritic joint pain; headache; skin irritation; bone marrow pain; tiredness after the first dose; body aches; This is a spontaneous report from a contactable consumer (patient).   A 67-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0182, Expiration date: unknown), dose 1 via an unspecified route of administration, administered in arm left on 18May2021 as 1st dose, single dose for COVID-19 immunization. Medical history included Covid infection in January that lasted approximately 3.5 weeks. The patient's concomitant medications included ongoing Vitamins. No history of all previous immunization with the Pfizer vaccine considered as suspect and no Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks. No relevant family history. On 19May2021 (Next day morning), the patient experienced 104 degree Fahrenheit fever, nausea, sweats, vertigo, arthritic joint pain, headache, skin irritation, bone marrow pain, body ache, tiredness because when she was sick tired, and she felt like she got the Covid all over again; and on 29May2021, the second day her fever was 100-98 degrees Fahrenheit. She reports that her symptoms post vaccination were mild compared to Covid infection and she was the only one she knows of that developed these symptoms post vaccination. Patient normal body temperature was reported as 97.7 degrees Fahrenheit. Skin irritation was explained as flashes of skin irritation where she didn't want anything to be touching her skin; her skin was irritated by clothes, sheets, and the floor. States her whole skin reacted. No visit to Emergency Room or Physician Office. Therapeutic measures were taken with 2 Tylenol. No relevant tests done. No Investigation Assessment. The patient underwent lab tests and procedures which included body temperature: 104 Fahrenheit on 19May2021, and 100-98 Fahrenheit on 20May2021. Patient reported she didn't have an allergic reaction. The outcome of event was recovered on 22May2021.  Follow up needed, further information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021669700 same reporter/ product, different patient.;US-PFIZER INC-2021667900 same reporter/ product, different patient.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: fever 104F/the second day her fever was 100-98 degrees; nausea; sweats; vertigo; arthritic joint pain; headache; skin irritation; bone marrow pain; tiredness after the first dose; body aches; This is a spontaneous report from a contactable consumer (patient).   A 67-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0182, Expiration date: unknown), dose 1 via an unspecified route of administration, administered in arm left on 18May2021 as 1st dose, single dose for COVID-19 immunization. Medical history included Covid infection in January that lasted approximately 3.5 weeks. The patient's concomitant medications included ongoing Vitamins. No history of all previous immunization with the Pfizer vaccine considered as suspect and no Additional Vaccines Administered on Same Date of the Pfizer Suspect. No Prior Vaccinations within 4 weeks. No relevant family history. On 19May2021 (Next day morning), the patient experienced 104 degree Fahrenheit fever, nausea, sweats, vertigo, arthritic joint pain, headache, skin irritation, bone marrow pain, body ache, tiredness because when she was sick tired, and she felt like she got the Covid all over again; and on 29May2021, the second day her fever was 100-98 degrees Fahrenheit. She reports that her symptoms post vaccination were mild compared to Covid infection and she was the only one she knows of that developed these symptoms post vaccination. Patient normal body temperature was reported as 97.7 degrees Fahrenheit. Skin irritation was explained as flashes of skin irritation where she didn't want anything to be touching her skin; her skin was irritated by clothes, sheets, and the floor. States her whole skin reacted. No visit to Emergency Room or Physician Office. Therapeutic measures were taken with 2 Tylenol. No relevant tests done. No Investigation Assessment. The patient underwent lab tests and procedures which included body temperature: 104 Fahrenheit on 19May2021, and 100-98 Fahrenheit on 20May2021. Patient reported she didn't have an allergic reaction. The outcome of event was recovered on 22May2021.  Follow up needed, further information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021669700 same reporter/ product, different patient.;US-PFIZER INC-2021667900 same reporter/ product, different patient.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: His grandfather tested positive in early March/received first dose of the vaccine and immediately after, tested positive for covid; His grandfather tested positive in early March/received first dose of the vaccine and immediately after, tested positive for covid; This is a spontaneous report from a Pfizer sponsored program support. A contactable consumer (patient's Grandson) reported that a 66-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: Unknown, Expiry date: Unknown) via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunisation. The patient's family medical history included his mom tested positive for Covid-19 and eventually passed it on. The patient's concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced, tested positive in early March/received first dose of the vaccine and immediately after, tested positive for COVID. Caller states a week after that, they decided for him to get a monoclonal antibody infusion. Agent states he read something about a ninety-day interval for patients who received antibody infusion before receiving the second dose, and since ninety days has passed, he wants to know if his grandfather can get the second dose, or if the antibodies are enough. Agent states he also wants to know was he still needs the second dose and will it be effective since so much time has passed or if he needs to start the whole vaccination periods all over again. The patient underwent lab tests and procedures which included sars-cov-2 test: positive on an unspecified date. The outcome of events was unknown.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Axillary pain, Fatigue, Insomnia, Malaise
Clinical narrative: He developed achiness on both sides under his arm pit extending primarily to pectoral muscles and deltoid; He developed achiness on both sides under his arm pit extending primarily to pectoral muscles and deltoid; He couldnt sleep because of the pain; Also reports stomach discomfort; Experienced fatigue; Feeling  under the weather and restless; Restlessness; This is a spontaneous report from a contactable consumer (patient's mother).Follow-up (06Jun2021) and Follow up (07Jun2021) received from previously reported consumer were processed together along with initial information.  A 23-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0187; Expiration Date: 31Aug2021), via an unspecified route of administration on 03Jun2021 (at an age of 23-year-old during vaccination) as a 2nd dose, single dose for COVID-19 immunisation. The patient's medical history included multiple allergic reactions (including drug allergies) after having his wisdom teeth out and had chest muscle pain. The patient's concomitant medications were not reported. The reporter stated that, the patient was not related to any study or programme. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on unspecified date as a 1st dose, single dose for COVID-19 immunisation. On 03Jun2021, the reporter stated that the patient experienced fatigue, feeling under the weather and restlessness. On Sunday early morning, the patient developed achiness on both sides under his arm pit extending primarily to pectoral muscles and deltoid, he could not sleep because of the pain and stomach discomfort. The reporter stated that as of last evening that it was kind of the same. No investigational assessment was reported. The reported wanted to know if her son chest muscles pain was normal or not. The reporter worried if her son needed medical care right away. The reporter concerned about lot number whether there was any issue involved with lot number. The reported stated that, the pharmacist did not follow proper procedure while with the administration of the vaccine however she was unable to identify a specific concern. The reporter was informed to provide information about side effects and to refer to doctor about side effects if there continue. The outcome of the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Myalgia, Restlessness
Clinical narrative: He developed achiness on both sides under his arm pit extending primarily to pectoral muscles and deltoid; He developed achiness on both sides under his arm pit extending primarily to pectoral muscles and deltoid; He couldnt sleep because of the pain; Also reports stomach discomfort; Experienced fatigue; Feeling  under the weather and restless; Restlessness; This is a spontaneous report from a contactable consumer (patient's mother).Follow-up (06Jun2021) and Follow up (07Jun2021) received from previously reported consumer were processed together along with initial information.  A 23-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: EW0187; Expiration Date: 31Aug2021), via an unspecified route of administration on 03Jun2021 (at an age of 23-year-old during vaccination) as a 2nd dose, single dose for COVID-19 immunisation. The patient's medical history included multiple allergic reactions (including drug allergies) after having his wisdom teeth out and had chest muscle pain. The patient's concomitant medications were not reported. The reporter stated that, the patient was not related to any study or programme. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration on unspecified date as a 1st dose, single dose for COVID-19 immunisation. On 03Jun2021, the reporter stated that the patient experienced fatigue, feeling under the weather and restlessness. On Sunday early morning, the patient developed achiness on both sides under his arm pit extending primarily to pectoral muscles and deltoid, he could not sleep because of the pain and stomach discomfort. The reporter stated that as of last evening that it was kind of the same. No investigational assessment was reported. The reported wanted to know if her son chest muscles pain was normal or not. The reporter worried if her son needed medical care right away. The reporter concerned about lot number whether there was any issue involved with lot number. The reported stated that, the pharmacist did not follow proper procedure while with the administration of the vaccine however she was unable to identify a specific concern. The reporter was informed to provide information about side effects and to refer to doctor about side effects if there continue. The outcome of the events was unknown.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Dysarthria, Epistaxis, Pain, Pyrexia
Clinical narrative: difficult to speak; nose bleed; fever; body aches; This is a spontaneous report from a contactable consumer (patient). A 30-years-old female patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient received bnt162b2 (PFIZER- BIONTECH COVID- 19 VACCINE, Solution for injection), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for covid-19 immunisation. On 04Jun2021, the patient experienced fever and body aches. On 07Jun2021, she experienced nosebleed and on an unspecified date she experienced difficult to speak. The patient stated she received her second Pfizer covid vaccine on Friday. Over the weekend she had fever and body aches. On 07Jun2021, morning she developed a nose bleed. She wanted to know how to what to do about her nose bleed specifically. She was calling for treatment advice and  agent referred her to her doctor. Agent asked if patient would like to complete a safety report based on the adverse events she has been experiencing. Patient stated if it is quickly, she could not speak more, and she would like to rest. Patient stated the fever has gone and she still has body aches. Patient stated did not had history and investigations, she was all good. Therapeutic measures were taken as a result of fever. The outcome of the event fever was recovered on 06Jun2021. The outcome of the event body aches was not recovered and unknown for nosebleed and difficult to speak.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: His son had a weepy nose (runny nose)/A lot of sniffing; This is a spontaneous report from a contactable consumer (parent). A 13-year-old male patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: UNKNOWN), via an unspecified route on 07Jun2021 (at the age of 13-years-old) as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2, via an unspecified route on unspecified date as 1st dose, single dose for covid-19 immunisation. On 07Jun2021, the patient experienced a weepy nose (runny nose)/a lot of sniffing. Caller advised that her 13 year old soon to 14 year son got his second dose today and he is okay but he has a runny nose and a lot of sniffing and she wanted to know if it would be alright to give him Benadryl. The clinical outcome of the his son had a weepy nose (runny nose)/a lot of sniffing was unknown.  Information about batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache, Somnolence
Clinical narrative: headache; Tiredness; slept all day; really draggy; This is a spontaneous report received from a consumer (patient) via other company. A patient of an unspecified age and gender received (Pfizer Covid 19 Vaccine, Solution for injection) via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that, "after the Covid vaccine, patient had headache and tiredness was really draggy, and slept all day Pfizer Covid 19 vaccine". Reported of ADRS where the initial reporter identified the suspected drug as one marketed by another applicant, should be forwarded to that applicant. Outcome of the events was unknown.  Information on lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Pain, Somnolence
Clinical narrative: so sore everywhere and coulden't stay awake; coulden't stay awake; This is a spontaneous report from a non-contactable consumer (patient).  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number was not reported, Expiration Date was not reported), via an unspecified route of administration on 12May2021 as 2nd dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  The patient historical vaccine included first dose of BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE; Formulation: Solution for injection Batch/Lot number/Expiration Date was not reported), via an unspecified route of administration on unspecified date for COVID-19 immunization. Patient reported that his second Pfizer COVID shot was on 12May2021. Patient reported he was so sore everywhere & couldn't stay awake after the shot. Patient said those symptoms from the shot lasted for about 24 hours. The outcome of the events was unknown.  No further follow up attempts are possible. no further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: Developed a rash in her vaccinated arm; This is a spontaneous report from a contactable consumer (patient). A 69-year-old female patient reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown) via an unspecified route of administration on an unspecified date in May2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that the patient got her first dose of the vaccine mid of May2021 and was set to get her 2nd dose this weekend, but she developed a rash in her vaccinated arm on an unspecified date. The patient wanted to know if there were reports regarding delayed rash reactions in the vaccinated arm 2-3 weeks after getting the first dose of the Pfizer BioNTech COVID-19 Vaccine. She also wanted to know if it would be safe to take the second dose while experiencing rash. The outcome of the event was unknown.  Follow up attempts are needed. Information on lot/batch number is requested.
Sex: M
Vaccine: COVID19
Symptoms: Head discomfort, Paraesthesia, Tinnitus
Clinical narrative: he had a "pretty significant tinnitus" from the skull; he also had pressure at the base of the skull, he had pressure at the occipital region and sides of his head just above the soft tissues at the temporal area,; nerves tingling in his skull; This is a spontaneous report from a contactable consumer (patient himself). A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number: not reported), via an unspecified route of administration on an unspecified date as 1st dose, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced he had a "pretty significant tinnitus" from the skull, he also had pressure at the base of the skull, he had pressure at the occipital region and sides of his head just above the soft tissues at the temporal area and nerves tingling in his skull. The adverse events started 3-4 days after getting the first dose of the vaccine. He said it got worse after the second dose of the vaccine. He has already visited his physician, acupuncturist, and neurologist. The outcome of the events was unknown. There was not product quality complaint (PQC) present.  Information about Lot Batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Throat tightness; This is a spontaneous report from a contactable pharmacist. A 64-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), via an unspecified route of administration on 17May2021 as SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that the patient was resulted in throat tightness 15 minutes after dose in May2021. Asking for recommendation on whether patient should receive second dose. Outcome of the event was unknown.  Follow-up attempts are needed. Further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site mass
Clinical narrative: I have a patient with a lump at the injection site; This is a spontaneous report from a contactable pharmacist. A 43-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: not reported) via an unspecified route of administration on 25May2021 (at the age of 43-year-old) at a 2ND DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient previously took first dose of BNT162B2 for covid-19 immunisation. On an unspecified date in May2021 the patient experienced a hard lump underneath the skin at the injection site. The lump is not painful, but it is not going away and it bothers the patient that the lump is still there. Outcome of the event was unknown.  Information on Lot/Batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Migraine, Pain in extremity
Clinical narrative: mild migraine; sore arm; Caller stated she noticed that she is constipated; This is a spontaneous report received from a contactable consumer (patient). A 40-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: EW0191), via an unspecified route of administration, on Arm Left on 05Jun2021, as a 1st dose single for COVID-19 immunization. The patient medical history included ongoing irritable bowel syndrome (She does take a homeopathic pill, but she hasn't been taking it) and gallbladder removed. The patient's concomitant medications were reported as none. It was reported that, the patient got her first Pfizer COVID vaccine on 05Jun2021 (Saturday). On the same day (05Jun2021), when she got home, she had a mild migraine and sore arm. The same thing yesterday (06Jun2021) and today (07Jun2021). The migraine was only on the left side of her head, and it started 2 to 3 hours after the COVID vaccine. It went away 8-9 hours later. She took a small nap to help the migraine, and when she woke up, she felt the soreness. The sore arm started that night. She still has a little arm soreness. She got the shot in her left arm, and the soreness was in her left arm. Then, today she noticed that she has been constipated since the shot. She has IBS (irritable bowel syndrome), and normally when she has to go. She doesn't take medication for IBS because she doesn't have insurance. She does take a homeopathic pill, but she hasn't been taking it because she went on vacation. She noticed the constipation because after the vaccine she went and got her family breakfast. She always goes after eating. She ate three meals a day and still hasn't went. She has had her gallbladder removed, so she always goes. This was not like her, and she went fine on Friday. It was further stated that, she hasn't been taking the homeopathic pill for about a week and a half to two weeks now because she was on vacation. It was an IBS therapy pill (by Manufacturer TRP). The outcome of the event mild migraine was recovered on 05Jun2021, whereas not recovered from other events.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash; This is a spontaneous report from a non-contactable consumer (patient's mother). A 15-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on an unspecified date as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On unspecified date the patient experienced, the reporter stated that her son was due for his second dose of the Pfizer COVID-19 vaccine at place on 09Jun2021, but they plan to go and receive his second dose one day early and she was informed by the Pharmacist at her place that the vaccine can be refrigerated for a longer period of time now. She called to verify if this information was accurate. She stated that she thought the vaccine could only be stored in the refrigerator for 3-5 days, however, the Pharmacist told her that it can now be stored for 30 days. The reporter stated that her son received the first dose of the Pfizer COVID-19 vaccine around 19May2021, she was not entirely sure of the exact date, however she reported that he did develop a rash on the tops of both of his arms. She stated that it had mostly resolved but it was still slightly visible, and she can still barely feel it when she rubs his skin. She stated that he had very sensitive skin and he put on a shirt at his grandmother's house the night that he received his first dose, and he received a haircut that night as well. The patient's mother was not sure if the rash that appeared was associated with the shirt that he wore and the detergent that it was washed in or if it had to do with the Pfizer COVID-19 vaccine. The patient's mother wanted to know if side effects with the second dose of the Pfizer COVID-19 vaccine could be worse than with the first. She stated that her son did not really have any side effects with the first dose other than the potential rash that occurred. The patient's mother stated that she specifically had concerns about diarrhea with the second dose. The clinical outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Got ill; This is a spontaneous report from Pfizer Sponsored Program. A contactable consumer reported for a 63-year-old female patient (reporter's mother) via medical information team. A 63-year-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and expiration date: Unknown), via an unspecified route of administration on an unknown date in Jan2021 (at the age of 63-year-old) as  single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. Reporter said that patient received her first dose of the Pfizer COVID-19 vaccine in Jan2021 while living in PRIVACY and then "got ill" on an unknown date and moved to PRIVACY and she was unable to get her second dose to due age restrictions and availability and was able to get her second dose now. Reporter was wondered if her mother needed to repeat the series or just get the second dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: got the 1st dose in last march but after a week she tested positive with COVID virus; This is a spontaneous report from a contactable consumer (patient) from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EN6198), dose 1 via an unspecified route of administration on 02Mar2021 as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 08Mar2021, after a week later the patient tested positive with COVID virus got diagnosed with Covid-19 and had light symptoms. On 10Mar2021, Patient received monoclonal antibodies for the Covid-19. she undergo a with an body fluid infusion that was advised by her doctor, and when she ask about the 2nd dose when will be getting that she was informed not to get it for 3 months. and right now she want to know if she can go ahead and do that with facility where she got the 1st dose or she will be stating all over again? The patient underwent lab tests and procedures which included Covid test: positive on 08Mar2021. Therapeutic measures were taken with monoclonal antibodies and body fluid infusion as a result of covid-19. The outcome of event was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Rash
Clinical narrative: Broken out in a rash, felt extremely tired and fatigued, and brain fog; Broken out in a rash, felt extremely tired and fatigued, and brain fog; Broken out in a rash, felt extremely tired and fatigued, and brain fog; This is a spontaneous report from a contactable consumer (patient). A 56-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Lot Number: EW0178), via an unspecified route of administration on 27May2021 as 1st dose, single dose for COVID-19 immunization. Patient's medical history included osteoporosis, lung disease but it is very mild. It was reported that, a few months ago, on 28Mar2021, patient had a series of shingle shot and with the second shingle shot, patient also broke out in the same type of rash but this time, the first time with the shingle, patient had a rash on arms, legs, and chest but that cleared up. Patient waited longer than they told me to before getting the COVID-19 vaccine, the rash got cleared up, patient waited probably two to three more weeks, then patient got COVID-19 vaccine. Concomitant medications included prolia taken for osteoporosis from 14May2021, protonix (pantoprazole) and Valtrex. The patient experienced broken out in a rash, felt extremely tired and fatigued, and brain fog on 31May2021. The patient mentioned that she started noticing it 4 days after getting the first dose. The rash was still present, not getting any better; seem to be getting worse and was now being treated with cortisone. So, now the rashes are back, and patient just have a concern about getting second dose and asked what to do about that. Patient looking for some assistance and some support or advice. Patient shared that, would be travelling to the state of (withheld) and is required to have a COVID-19 Test just a few days after getting the COVID-19 vaccine. Patient mentioned the test is scheduled on 17Jun2021, and flight would be on 21Jun2021. The patient was not recovered from rash and the outcome of the events felt extremely tired and fatigued and brain fog was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Glycosylated haemoglobin, Glycosylated haemoglobin increased, Hypersomnia
Clinical narrative: Slept for 15 hours a day; Extreme fatigue; A1C is 8.4/HAC1 were at 8.4 post-vaccination; This is a spontaneous report from a contactable consumer (nurse). This consumer reported for 89-year-old female patient (reporters godmother).  A 89-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 19May2021 (at the age of 89-year-old) as 1st dose, single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. Reported stated that patient received the first dose of the Pfizer-BioNTech COVID-19 vaccine 19May2021. The reporter stated that patient HAC1 were at 8.4 (2021) post-vaccination and she has been experiencing extreme fatigue on an unknown date on 2021. She described her godmother as 'active' and explained 'she works out, attends her physical therapies, and swims'. Reporter asked for the efficacy of a single dose of the Pfizer-BioNTech COVID-19 vaccine. Reporter again stated, she had extreme fatigue, her A1C is 8.4 and she doesn't have side effects listed. She slept for 15 hours a day (2021). She was scheduled for her next injection on Wednesday and they were concerned about the second injection. They didn't know if they could postpone it and if they did, does it affect the effectiveness. She wants to know the percentage of coverage after the first injection and how long she can wait. The events were reported as non-serious. The patient underwent lab tests and procedures which included A1C: 8.4 on 2021. The outcome of events were unknown.  Information on Lot/Batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Illness, Pyrexia
Clinical narrative: In bed with a fever; Chills; Tiredness; felt sick for two days; This is a spontaneous report from a contactable Nurse (Mother). A male patient of an unspecified age received BNT162B2 (Formulation: Solution for injection; Batch/Lot number: unknown), via an unspecified route of administration on an unspecified date as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date caller was reporting on herself, she mentioned her son got the Pfizer covid vaccine and for two days he was in bed with a fever and chills and everything. She states he had tiredness, fever, chills and felt sick for two days. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Feeling cold, Nasopharyngitis
Clinical narrative: slight cold/feeling a cold; slight cold/feeling a cold; This is a spontaneous report from a Pfizer-sponsored program A non-contactable consumer (patient) reported that a male patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number: Unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient had slight cold/ feeling a cold. He asked whether he should get the second dose the next day and did the vaccine contain live virus. The outcome of the events was unknown.  No follow up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain
Clinical narrative: little bit of weird pain on his arm pit; This is a spontaneous report received from a contactable consumer (Patient). A male patient of an unspecified age received BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, (Batch/Lot number was not reported, Solution for injection), via an unspecified route of administration on 24May2021 as unknown, single dose for covid-19 immunization. The patient medical history and concomitant medications were not reported.  On an unspecified date, the patient experienced little bit of weird pain on his arm pit. He was vaccinated on 24May2021, and he still had a little bit of a weird pain on his arm pit. His kids and wife were feeling better, he wanted to know how long this will last. The outcome was not recovered. Information on the lot/batch number has been requested.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Influenza, Malaise, Sluggishness
Clinical narrative: Wasn't feeling great after first vaccine; sluggish; This is a spontaneous report from a contactable consumer (patient's wife).  A 47-years-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Lot Number: EP7533; Expiration Date: Jul2021), via intramuscular route of administration in Arm Left on 11Apr2021, as 1st dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient doesn't take any medication, doesn't drink or do drugs, he was a very healthy person. Patient has nothing and that's what was so strange, Patient was a tall, healthy person. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. It was reported that he wasn't feeling great after first vaccine and sluggish. The patient underwent lab tests and procedures which included covid-19: and influenza: negative on 25May2021. The outcome of the events was unknown.  Information on Lot/Batch number is available; Further information has been requested.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood pressure measurement, Joint swelling
Clinical narrative: my left ankle was lightly swollen yesterday and it's still swollen today; This is a spontaneous report from a contactable consumer (reported for himself). A 65-year-old male patient received second dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection, Batch/lot number and Expiration date were not reported), via an intramuscular route on the right arm on 01Jun2021 (age at vaccination: 65-year-old) as a single dose for covid-19 immunization. Medical history included high cholesterol and high blood pressure. Concomitant medications included amlodipine Besylate 10 mg for high blood pressure and atorvastatin, 30mg tablet for cholesterol. Historical vaccine included first dose of BNT162B2 (Pfizer covid-19 vaccine, Solution for Injection) as a single dose for covid-19 immunization. Family history included swollen ankle of patient father who is 95-year-old. Patient did not receive any other vaccine after the covid vaccine. On 05Jun2021 yesterday, patient mentioned that his left ankle was lightly swollen yesterday, and it's still swollen today. He wanted to know if that is something he should worry about as the side effect. The patient underwent lab test and procedure which included blood work up and it all came out good, his cholesterol was low, and his blood pressure was good. The clinical outcome of the left ankle was not recovered.  Information on the lot/batch number has been requested.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm hurt a little; This is a spontaneous report from a contactable consumer.   A 62-years-old male consumer (patient) reported for himself that he received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number, expiry date and NDC number were not reported) via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. Medical history, other products, investigation assessment and concomitant medications were not reported. On an unknown date, the patient reported that his arm hurt a little bit after first shot of vaccine. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, Chest pain, Fatigue
Clinical narrative: Felt tired; Back hurts; Pop in neck and back; Pop in neck and back; Headache; Cramps, sometimes in his legs and hands; Feels weak sometimes; Has a little bit of pain in his chest; Body hurt, reclarified, joints hurt; This is a spontaneous report from a contactable male consumer reported for himself. A 62-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot Number: unknown, Expiration date: unknown), via unspecified route, on 03May2021 (at the age of 62-year-old) as 2nd dose, single dose for COVID-19 immunization. Patient previously received the first dose of BNT162B2 vaccine on an unspecified date (lot/batch and expiry date unknown). The patient medical history and concomitant medications were not reported. On 03May2021, after the vaccination, the first day patient felt tiredness, later (unspecified date in May2021) the patient explained his body hurt- reclarified as joints hurt, back hurts, pop in his neck and back, headache, cramps sometimes his legs and hands, feels weak sometimes, little bit of pain in his chest. Caller stated he has waited for his effects to go away, but it has been a month. Caller stated his body hurt, reclarified as joints hurt, and it was not going away (not recovered). The outcome of the other events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.