chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Affective disorder, Chest discomfort, Nausea, Rash
Clinical narrative: nausea; her daughter has the same tightness; very irritated yesterday; it was not tangible like a rash; This is a spontaneous report from a contactable consumer. This consumer (patient Mother) reported for a female patient. A female patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose number unknown, single for covid-19 immunisation. Medical history included asthma. The patient's concomitant medications were not reported. Consumer reported that, on an unspecified date, her daughter has the same tightness and was okay, she does not indicate that she had the akathisia - but she had it too with the same drugs. Caller adds she had not talked to her today, which she needs to. Her daughter got very, very irritated yesterday. She had to take her daughter's son who was 2. Her daughter was like okay mom I noticed I am getting uptight and this thing they get, it was not tangible like a rash. There are no symptoms on the body, like okay, it was more of a mental reaction if you want to rip an IV out or move weird to get out of a room, moving weird. Caller clarifies that this was something bother and her daughter get. Reglan was when it happens to caller. They do not have antipsychotics, they take nausea that they have with it and are also given Phenergan with that. Her daughter gets very, very irritated with the same things like that, she has the same thing that happens with the drugs that do that. It was certain antibiotics that do this. She noticed yesterday that her daughter was the same way, hostile. Caller adds that her daughter was the same way, hostile. It was weird in the hospital, they are pacing and talking like how she was talking now. They have to get stuff in the IV that calms them down. If they make a mistake or have a reaction, they tell us where they can see it, moving feet on the bed, and they have to give them something to use. Genetically, they have the same reaction. The outcome of the events was unknown.  Information on Lot/Batch information has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy test, Hypersensitivity, SARS-CoV-2 test, Urticaria
Clinical narrative: Severe allergic reaction with hives; Severe allergic reaction with hives / Allergic urticaria; This is a spontaneous report from a contactable consumer (patient) and physician. A 32-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), second dose via an unspecified route of administration in the left arm on 16Jan2021 at 16:30 (Batch/Lot Number: BMG az nw pod, at the age of 32-year-old at vaccination) as a single dose for COVID-19 immunisation.  Medical history was reported as none. The patient has no known allergies. The patient did not receive any other vaccine within four weeks of the vaccination. There were no concomitant medications. Historical vaccine information included the patient received the first dose of BNT162B2 on 29Dec2020 at 16:30 PM (Batch/Lot number: BMG nw pod, at the age of 32-year-old at vaccination) as a single dose for COVID-19 immunisation. On 16Jan2021 at 16:30 the patient received the second dose of the BNT162B2 vaccine. On 29Jan2021 at 07:00, "right after" the vaccination, the patient developed a severe allergic reaction with hives. He went to 3 different allergist and it was not found to be a food allergy. The patient stated he has reason to believe the vaccine caused the reaction since it's a possible reaction. It has been 4 months and he was miserable. The antihistamines were not working. Steriods help 80% but he feels horrible from taking them. The event has resulted in doctor or other healthcare professional office/clinic visit. On 18Apr2021, the patient had a televisit follow up. On 18Apr2021, the patient had a food allergy lab test with unknown results. On 03May2021, the physician saw the patient for allergic urticaria. The physician saw the patient several months after the reaction. The physician reported discrepant therapy dates for the BNT162B2 vaccine (the first dose was received on 07Jan2021 and the second dose was received 21Jan2021). The patient has not tested positive for COVID-19 post vaccination. Post vaccination: PCR COVID-19 SARS-CoV-2 test was negative on 30May2021. The reporting physician considered that the causal effect to the adverse event with the BNT162B2 vaccine was possible. The outcome of the event severe allergic reaction with hives / allergic urticaria was not recovered.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: numbness in left hand, middle, index finger, thumb, and ring finger; pain along inner arm; This is a spontaneous report from a contactable physician (who is also the patient). A 78-years-old male patient received bnt162b2 (BNT162B2, formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left, left deltoid on 21Jan2021 6:30pm (Batch/Lot Number: EL9267) as 1ST DOSE, SINGLE for covid-19 immunisation (preventative). Patient Age at Time of Vaccination in Months: or Years: 78 years. Medical history included diabetes mellitus, coronary artery disease, high blood pressure, prostate cancer and a little arthritis. Concomitant medication(s) included metformin (METFORMIN), metformin hydrochloride, sitagliptin (JANUMET), ramipril (RAMIPRIL), amlodipine (AMLODIPINE), atorvastatin (ATORVASTATIN), metoprolol (METOPROLOL) and aspirin [acetylsalicylic acid] (ASPIRIN) taken for an unspecified indication from an unspecified start date and ongoing. The patient experienced pain along inner arm on 03Feb2021 and numbness in left hand, middle, index finger, thumb, and ring finger on 04Feb2021. He developed pain in the arm, not at the injection site, but along the inner arm. The next day he developed numbness in the left side of the hand, in the middle and ring finger. A couple of days later he developed teh same thing on the thumb and index finger. A few days later, he woke up in the night and had wrist drop in the left hand. He recovered most strength of muscles and was able to lift the fingers. Within the next few days, he recovered his strength in his muscles. The numbness continued to be there but, slowly showing some improvement. He still has little patches of it. The outcome of the event pain in extremity was unknown and hypoaesthesia was recovering. Communication: The caller was provided with phone number of , option 3, for COVID-19 vaccine inquiries.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Contusion, Decreased appetite, Feeling abnormal
Clinical narrative: My daughter states that she has lower spine pain that is constant.; She says the pain feels like a bruise, "like ouch, I don't want to move; 101 fever; Loss of appetite; Headache; Nausea; Weakness; Shaking; Slight and stuffy nose; She says the pain feels like a bruise, "like ouch, I don't want to move; This is a spontaneous report from a contactable consumer (patient's parent). A 13-years-old non pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 03Jun2021 15:15 (at the age of 13 years) (Batch/Lot Number: EW0217) as dose 2, single for covid-19 immunisation. Medical history included none. Known allergies was none. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Patient did not receive any other medications within 2 weeks of vaccination. The patient historical vaccine included, patient received BNT162B2 via an unspecified route of administration, administered in Arm Left on 13May2021 03:15PM (at the age of 13 years) (Lot Number: ER8729) as dose 1, single for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered at pharmacy or drug Store. Reported Event: My daughter states that, on 04Jun2021 at 10:00 she has lower spine pain that was constant. She says the pain feels like a bruise, "like ouch, I don't want to move" Withheld also has to lay in a semi fetal position to feel most comfortable. This symptom is the most concerning of the other symptoms, 101 fever, loss of appetite, headache, nausea, weakness, shaking, slight and stuffy nose. Since the vaccination, patient had not tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 101 on 04Jun2021. Treatment received for the events was unknown. The outcome of the events was not recovered.   Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nasal congestion, Nausea, Pyrexia, Spinal pain
Clinical narrative: My daughter states that she has lower spine pain that is constant.; She says the pain feels like a bruise, "like ouch, I don't want to move; 101 fever; Loss of appetite; Headache; Nausea; Weakness; Shaking; Slight and stuffy nose; She says the pain feels like a bruise, "like ouch, I don't want to move; This is a spontaneous report from a contactable consumer (patient's parent). A 13-years-old non pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 03Jun2021 15:15 (at the age of 13 years) (Batch/Lot Number: EW0217) as dose 2, single for covid-19 immunisation. Medical history included none. Known allergies was none. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Patient did not receive any other medications within 2 weeks of vaccination. The patient historical vaccine included, patient received BNT162B2 via an unspecified route of administration, administered in Arm Left on 13May2021 03:15PM (at the age of 13 years) (Lot Number: ER8729) as dose 1, single for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered at pharmacy or drug Store. Reported Event: My daughter states that, on 04Jun2021 at 10:00 she has lower spine pain that was constant. She says the pain feels like a bruise, "like ouch, I don't want to move" Withheld also has to lay in a semi fetal position to feel most comfortable. This symptom is the most concerning of the other symptoms, 101 fever, loss of appetite, headache, nausea, weakness, shaking, slight and stuffy nose. Since the vaccination, patient had not tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 101 on 04Jun2021. Treatment received for the events was unknown. The outcome of the events was not recovered.   Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: My daughter states that she has lower spine pain that is constant.; She says the pain feels like a bruise, "like ouch, I don't want to move; 101 fever; Loss of appetite; Headache; Nausea; Weakness; Shaking; Slight and stuffy nose; She says the pain feels like a bruise, "like ouch, I don't want to move; This is a spontaneous report from a contactable consumer (patient's parent). A 13-years-old non pregnant female patient received bnt162b2 (BNT162B2), via an unspecified route of administration, administered in Arm Left on 03Jun2021 15:15 (at the age of 13 years) (Batch/Lot Number: EW0217) as dose 2, single for covid-19 immunisation. Medical history included none. Known allergies was none. Prior to vaccination, patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient's concomitant medications were not reported. Patient did not receive any other medications within 2 weeks of vaccination. The patient historical vaccine included, patient received BNT162B2 via an unspecified route of administration, administered in Arm Left on 13May2021 03:15PM (at the age of 13 years) (Lot Number: ER8729) as dose 1, single for Covid-19 immunization. Facility where the most recent COVID-19 vaccine was administered at pharmacy or drug Store. Reported Event: My daughter states that, on 04Jun2021 at 10:00 she has lower spine pain that was constant. She says the pain feels like a bruise, "like ouch, I don't want to move" Withheld also has to lay in a semi fetal position to feel most comfortable. This symptom is the most concerning of the other symptoms, 101 fever, loss of appetite, headache, nausea, weakness, shaking, slight and stuffy nose. Since the vaccination, patient had not tested for COVID-19. The patient underwent lab tests and procedures which included body temperature: 101 on 04Jun2021. Treatment received for the events was unknown. The outcome of the events was not recovered.   Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: little sore arm; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on 04Apr2021 (Batch/Lot number was not reported) as UNKNOWN, SINGLE for covid-19 immunisation; estrogens conjugated (PREMARIN), route of administration, start and stop date, batch/lot number and dose were not reported for an unspecified indication. The patient medical history and concomitant medications were not reported. Patient called in seeking assistance with the medication Premarin. During the call patient stated." I'm a little bit dumb. Patient later stated on the call." I just got the Pfizer vaccine too 04Apr two of them all I had was a little sore arm." The outcome of the event was unknown.  Information about lot/batch number has been requested.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Pain in extremity, Pyrexia
Clinical narrative: Chills, fever, severe pain in arm, aches all over, tired; Chills, fever, severe pain in arm, aches all over, tired; Chills, fever, severe pain in arm, aches all over, tired; Chills, fever, severe pain in arm, aches all over, tired; Chills, fever, severe pain in arm, aches all over, tired; This is a spontaneous report from a contactable consumer. A 63-Year-old male consumer (patient) reported that patient received Bnt162b2 (BNT162B2; Formulation: Solution for injection; LOT#: ew0183) via unknown route of administration from 20May2021 09:30 2nd dose on left arm for COVID-19 immunization, and Bnt162b2 (BNT162B2; Formulation: Solution for injection; LOT#: ew0175) via unknown route of administration from 29Apr2021 09:45 1st dose on left arm for COVID-19 immunization. Patient's medical history includes stroke 36 years ago, and no known allergies reported. Facility type vaccine includes doctor's office/urgent care. If covid prior vaccination no, no if covid tested post vaccination. It was reported that Chills, fever, severe pain in arm, aches all over, tired and no treatment received. The outcome of the events was recovered.  Follow-Up (12Jul2021): Follow-up attempts are completed. No further information is expected.  Follow-Up (27Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Rash, Swelling
Clinical narrative: Painful swelling and rash in left armpit and chest; Painful swelling and rash in left armpit and chest; Painful swelling and rash in left armpit and chest; Painful swelling and rash in left armpit and chest; This is a spontaneous report from a contactable consumer reported for himself. A 40-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration administered in left arm on 07Jun2021 at 13:30 (at age of 40-years-old)  as dose 2, single for COVID-19 Immunisation. Patient medical history  and concomitant medications  were not reported. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number & Expiry date not reported) via unspecified route of administration, administered in left arm on 17May2021 at 13:30 (at age of 40-years-old) as dose 1, single for COVID-19 Immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within two weeks. The patient was not diagnosed with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 08Jun2021 at 7:00 ( 1 days after vaccination) Patient experienced painful swelling and rash in left armpit and chest. No treatment received by patient to events. The Outcome of events was not Recovered   Follow-up (14Jul2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to HCP letter sent via telephonic follow-up activity that included:  No information was obtained.  Information on the Batch/Lot number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: Muscle Aches; Headache; This is a spontaneous report from a contactable consumer. This 56-year-old (age at vaccination) female consumer reported in response to Non-HCP follow-up letter sent that included that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection lot number; ER8735) via an intramuscular route of administration on 19Apr2021 at 10:00 in left arm for covid-19 immunisation. Vaccine facility type was reported as Pharmacy or drug store. Patient's medical history and relevant tests was reported as none. Concomitant medications was reported as none. Prior vaccination within 4 weeks was none. Patient took second dose of BNT162B2, Batch/Lot number: EW0167 via an intramuscular route of administration on 10May2021 at 10 am in left arm for covid-19 immunisation. Patient experienced muscle aches, headache on 20Apr2021 at 03:00 am. Treatment was given for the AE (Aleve). Patient experienced rash on 20May2021 at 08:00 pm. Seriousness criteria for the events was provided as non serious. Treatment given for the AE was Benadryl for seven days. Autopsy information was not provided. The outcome of event myalgia and headache was recovered on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Dyspnoea, Palpitations
Clinical narrative: Heart palpitations; congestion; Hard time breathing; This is a spontaneous report from a Pfizer- sponsored program. A contactable 66-year-old- male patient (consumer) received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Right on 26Apr2021 11:30 (at the age of 66 years) (Lot Number: EW0169) as dose 2, single for covid-19 immunisation. Medical history included ongoing blood cholesterol (He has had about a year). History of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available) was None. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. Family Medical History Relevant to adverse events was none. The patient's concomitant medications were not reported. Patient historical vaccine included, on 05Apr2021 at 11:30 received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection), via an unspecified route of administration, administered in Arm Right (Lot Number: EW0150) as dose 1, single for covid-19 immunisation and experienced heart palpitations, hard time breathing. Warm transfer from (name withheld) from Pfizer. Transfer agent provided zip code as (withheld) Later caller verified zip code as correct. Transfer agent stated that the caller had side effects after getting the Pfizer Covid-19 vaccine. He had heart palpitations, congestion and a hard time breathing. Caller said that he was congested and he never had this before. He said it was hard to breathe. When caller was asked when he had the vaccine, he said about 2 months ago. Facility: Caller stated he got the shot at the University of (name withheld) when they were handing them out. It was a drive-thru clinic. Caller did not have an address or phone number to provide. Events: Caller stated that the events happened after the first shot all at the same time. Then he said the congestion was after the second shot. The congestion was persisting. Caller said that he couldnt remember if the hard time breathing happened after both shots, but it is still happening. It is persisting. When he was up and walking around, it was happening on and off. Caller clarified that the congestion and hard time breathing were related to each other. Relevant Tests was none.  Communication: Advised caller that this safety report would be submitted and then he might be contacted. Advised caller that he might receive something in the mail. The outcome of the events was not resolved.  Follow-up attempts are needed. Further information is expected.  Follow-Up (20Jul2021): Follow-up attempts are completed. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Groin pain, Pain in extremity
Clinical narrative: her arm pain was more so with the first dose but felt arm pain with the second dose as well; pain in groin; the top of her right leg was in pain; This is a spontaneous report from a Pfizer sponsored program.  A 63-years-old female patient received bnt162b2 (BNT162B2, Solution for injection), dose 1 intramuscular, administered in Arm Right on 15Apr2021 15:30 (Batch/Lot Number: EL9265) as 1ST DOSE, SINGLE DOSE, dose 2 intramuscular on 06May2021 (Batch/Lot Number: EL3247) as 2ND DOSE, SINGLE DOSE for covid-19 immunisation. Age at vaccination was 63 years. The patient medical history and concomitant medications were not reported. It took a day after the second vaccine, she understands arm pain is normal. She accepts the pain in arm as territory when getting a shot, she heard her arm will hurt. Clarifies her arm pain was more so with the first dose but felt arm pain with the second dose as well. She wants to jump to the major issue. She explains that last Saturday evening, which was almost a month to the day after her second dose, she got a severe pain in her right groin, very intense to the point she can no longer walk that well and cannot do too many things. She has been on extra strength Tylenol since Saturday. She has tried to do everything she can to alleviate the pain and it is wearing her out, she is tired and at one point she felt really cold, the top of her right leg was in pain and now it went back to the groin. It is very severe and she is trying not to take Tylenol. Tylenol helps but she does not like being on Tylenol. Therapeutic measures were taken as a result of her arm pain was more so with the first dose but felt arm pain with the second dose as well (pain in extremity). The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Mass
Clinical narrative: golf ball size round mas; This is a spontaneous report from a non-contactable consumer or other non hcp.    A patient of unspecified age and gender received bnt162b2 (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 Jan2021 as 1st dose, single dose for covid-19 immunisation.  Medical history included joint swelling from Aug2020 to an unknown date swelling on my Left knee Aug2020. The patient's concomitant medications were not reported. It was Reported that, My experience is good regarding Pfizer vaccine felt on my knees and had a huge swelling on my Left knee Aug2020. For several months could felt pain on that part of my knee but there was no swelling. In Jan2021 had my first Pfizer vaccine. Within 48 hours there was a golf ball size round mass on the area. Non tender but was scared. It persisted until my second dose. However, within 48 hours the mass disappeared, and my knee was back to normal. I have no more pain no stiffness on the area.  The event golf ball size round mass on an unspecified date with outcome of unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained
Sex: U
Vaccine: COVID19
Symptoms: Illness, Pain
Clinical narrative: I got really sick; I am still feeling like body pain; This is a spontaneous report from a contactable consumer. A patient of an unspecified age and gender patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: unknown, Expiration date: unknown), via unspecified rout of administration on an unspecified date as unknown dose number, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that "I have a little bit of concern I got the Pfizer on Saturday and I got really sick on Saturday night so I am still pretty kind of sick. I don't know if I should feel this way." The patient got really sick and had body pain on an unspecified date. The patient wanted to know if should stay here on the house or keep drinking traitor like was still feeling like body pain. Outcome of event was not recovered.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspnoea, Fatigue, Feeling abnormal, Headache
Clinical narrative: fatigue/tired; weakness; numbness/feels numbness in her arms, in her shoulders even while sitting, sleeping, even when she wakes up; shortness of breath; low fevers; miserable condition; permanent headaches; pain; This is a spontaneous report from a contactable consumer (patient husband). A consumer (patient husband) reported for patient (wife) that: A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0180), via an unspecified route of administration, administered in Arm Left on 07Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration, administered in Arm Left on 20May2021 as single dose for covid-19 immunisation and experienced the events Headache, fever, shortness of breath, pain in the arms and shoulder, numbness and weakness. Reporter stated, we both had our both doses, my wife took her second dose was on 07Jun2021 and on 10Jun2021 both of us especially my wife has been going through a lot of fatigue, weakness, numbness, I mean shortness of breath, everything that is possible is going on with her, I mean heart beat and I mean she feels numbness in her arms, in her shoulders even while sitting, sleeping, even when she wakes up she is tired, going to bed she is tired, during the day especially after, in the afternoon. As far as I remember almost every day, we have been getting temperatures. We have like low fevers and especially her she is in kind of miserable condition because of shortness of breath. We take some stairs up to our apartment and she has to sit down for like 5 minutes to catch up her breath and pain, she has permanent headaches almost for the past two weeks. Specially After the second dose she is experiencing a very bad kind of reactions. Reporter stated his wife especially after second dose it has been since 10Jun2021 and ever since that day. I mean her condition is, and she is experiencing the same kind of symptoms every day. Therapeutic measures were taken as a result of the events with Ibuprofen. The outcome of the events was reported as not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain, Pyrexia
Clinical narrative: fatigue/tired; weakness; numbness/feels numbness in her arms, in her shoulders even while sitting, sleeping, even when she wakes up; shortness of breath; low fevers; miserable condition; permanent headaches; pain; This is a spontaneous report from a contactable consumer (patient husband). A consumer (patient husband) reported for patient (wife) that: A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0180), via an unspecified route of administration, administered in Arm Left on 07Jun2021 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient's historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: EW0187), via an unspecified route of administration, administered in Arm Left on 20May2021 as single dose for covid-19 immunisation and experienced the events Headache, fever, shortness of breath, pain in the arms and shoulder, numbness and weakness. Reporter stated, we both had our both doses, my wife took her second dose was on 07Jun2021 and on 10Jun2021 both of us especially my wife has been going through a lot of fatigue, weakness, numbness, I mean shortness of breath, everything that is possible is going on with her, I mean heart beat and I mean she feels numbness in her arms, in her shoulders even while sitting, sleeping, even when she wakes up she is tired, going to bed she is tired, during the day especially after, in the afternoon. As far as I remember almost every day, we have been getting temperatures. We have like low fevers and especially her she is in kind of miserable condition because of shortness of breath. We take some stairs up to our apartment and she has to sit down for like 5 minutes to catch up her breath and pain, she has permanent headaches almost for the past two weeks. Specially After the second dose she is experiencing a very bad kind of reactions. Reporter stated his wife especially after second dose it has been since 10Jun2021 and ever since that day. I mean her condition is, and she is experiencing the same kind of symptoms every day. Therapeutic measures were taken as a result of the events with Ibuprofen. The outcome of the events was reported as not recovered.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Heart rate, Heart rate increased
Clinical narrative: blood "gushing" internally; heart began to pump at a rate well above normal; This is a spontaneous report from a contactable consumer (patient). A 51-year-old non-pregnant female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0182, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 12May2021 14:30 as dose 2, single for covid-19 immunisation administered at Pharmacy or Drug Store. The patient medical history and concomitant medications were not reported. The historical vaccine includes bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: ER8736, Expiry date: unknown), via an unspecified route of administration, administered in Arm Left on 21Apr2021 14:30 as dose 1, single for covid-19 immunisation. Other vaccine in four weeks was none. Covid was not tested prior to and post vaccination. No Known allergies. On 06Jun2021 08:00 PM, the patient reported, she was walking to a convenience store in a hurry. She picked up her pace and her heart began to pump at a rate well above normal. As a former runner, she would say it felt like she was running fast. She slowed down, her heart did not. She could feel her heart pumping blood like crazy, even after sitting. It took almost an hour of non-motion before her heart/pulse rate went back to normal. This has happened several times since though she had slowed down considerably and not "let" her heart/pulse rate increase beyond a certain level. Subsequent events feel like an instant increase of heart/pulse rate. Not running levels but, sudden fast pumping and she could feel her blood "gushing" internally. Even just moving at a leisurely pace. Patient did not received treatment for events. The outcome of the events was not recovered.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Malaise, Nausea
Clinical narrative: I had upset stomach; diarrhea; Nausea; I don't feel well; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection, Lot number: EW0185) via unspecified route of administration on 25Jun2021 as dose 2 single for COVID-19 immunization. Medical history and Concomitant medications were not reported. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Lot number: EW0161) on 04Jun2021 for COVID-19 immunization. It was reported that patient had a couples of side effects four days later. I had upset stomach, diarrhea for 1 day in Jun2021 and then 8 days later Saturday it began with yesterday in particular and today a lot of nausea in 2021 and you know, yeah and I am taking something over the counter stuff called Tauzin (Treatment) which may be helpful little bit." I want to know if that's okay. Consumer stated "I don't feel well in 2021. It's hard for now." The outcome of event diarrhea recovered in Jun2021, while for other events was unknown.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cough, Oropharyngeal pain, Pain in extremity, Rhinorrhoea, Sneezing
Clinical narrative: Cough; Sore throat; Sneezing; Runny nose; Sore Arm; This is a spontaneous report from a contactable consumer (patient). A female patient of unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number: unknown, Expiration date: unknown), via unspecified route of administration on 05May2021 as dose 2, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 on 14Apr2021 as Dose1, SINGLE for covid-19 immunization and had no adverse events. The patient experienced cough, sore throat, sneezing, runny nose and sore arm on an unspecified date after vaccination. The patient stated that, I had after my shot, I had the first shot on 14Apr and second one on 05May. I had no problem at all, all I had was a sore arm but now it started like, I got this little cough but I don't have it right now but I have the cough and now I got the runny nose and this cough a little bit sneezing. I mean but what I am trying to talk about its try to find out, I mean I do not feel sick and all like that but like probably having the shot and somebody said you probably got a back again and I thought I rather call you all to find out, What is going on. I mean it probably goes away but I would like to feel more sure, If I am sick and all and you all could tell me you know, Is it ok right. The outcome of the events cough, sneezing and runny nose was not recovered and the outcome of the rest of the events was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Chest pain, Dyspepsia
Clinical narrative: Some people are experiencing you know heart burn maybe I am only that's getting heartburn; it is like substernal chest pain; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received bnt162b2 (Covid 19 Vaccine; formulation: solution for injection; manufacturer: Unspecified; Lot number and Expiry Date: Unknown), via an unspecified route of administration on an unspecified date as unknown dose, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient reported that ''I am actually a health care provider and actually have a question, few people just mentioned, I mean not at all the warming side effect, nothing adverse effect anything like that, I had mentioned the side effects of heart burn on an unknown date. Just the heart burn in suggestion, it is like substernal chest pain, following the covid vaccination on an unknown date and the first couple of people who asked me about it. I have heard that and obviously you know one really have any answers for the kind of that trend continue and I was surprised only when I got the vaccine, I have the same side effects, so, I guess I have multi heart question. So I guess its curiosity. Trying to find out more information to pass that information to the patient when they ask." The outcome of the events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Feeling hot
Clinical narrative: his chest is all red, his chest and his face and his forehead all like burning red and feels very hot; his face got all red, his chest is all red, his chest and his face and his forehead all like burning red and feels very hot; This is a spontaneous report from a contactable consumer Submitted by Call Center. This consumer reported for the patient(son). A 52-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/lot number, expiration date and NDC number were unknown) via an unspecified route of administration, administered on 01Jul2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The reporter stated that my son took the Pfizer vaccine 4 days ago, yesterday (04Jul2021) his face got all red, his chest is all red, his chest and his face and his forehead all like burning red and feels very hot, he has no fever, he has no other symptoms so burning is this is 4 days after the vaccine and questioned have you heard anything like that form your vaccine? It was white like it was retaining something. Vital signs were normal. When we take Benadryl it seemed to help. The patient took treatment for all the events. The outcome of all the events was unknown.   Information about lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Rash
Clinical narrative: Have a rash on my legs, it's just my lower legs; Saw the rash today; Leg started itching; Hurt a little bit; This is a spontaneous report received from a contactable consumer (patient herself). A 53-year-old-female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EW0177 and expiry date: Aug2021) via an unspecified route of administration in left arm on 02Jul2021 13:45 as single dose for COVID-19 immunization. Patient medical history included Hashimoto, Epstein Bar and Asthma. Concomitant Medications were reported as none. Patient stated that "she got vaccinated on 02Jul2021and she just wanted to report that she has a rash on her legs, it's just her lower legs on 05Jul2021". She got the shot on Friday and her leg started itching Saturday on 03Jul2021 and then she saw the rash today, she had issues with 'Asthma' in the past (intent of medical history). On an unspecified date in Jul2021 patient stated, "she took Just like a regular shot, she doesn't really know, she mean it hurt a little bit." Time of Administration of vaccine was reported as patient stated that "the time, so like it was around 01:30, it might have been closer to 2, she is thinking that her appointment was at 01:30 and she got it about it quarter to 2 is what she is thinking, yes she got it at 1:45 in afternoon". Outcome of events was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Nasopharyngitis, Rhinorrhoea, Sneezing
Clinical narrative: bad cough; runny nose; sneezing; cold like illness; This is a spontaneous report from a contactable consumer or other non hcp.   A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 06Jun2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date in 2021, the patient experienced bad cough, runny nose, sneezing and cold like illness. The patient wanted to reschedule the second dose, he stated that he had running nose and he was advised to call vaccine provider or the site for assistance and he also wanted to know if there was a specific waiting period he needs to wait after cancelling the appointment or a timeline. The outcome of the cough, rhinorrhoea, sneezing, nasopharyngitis was unknown.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Lymphadenopathy, Neck pain, Nodule, Pain
Clinical narrative: I had severe back pain like achiness, like the flu but it wasn't that's all, it was not, it went to my neck down to my waist that is very bad.; I had severe back pain like achiness, like the flu but it wasn't that's all, it was not, it went to my neck down to my waist that is very bad.; large node on her neck; she felt very achy and just the day, she noticed that, there is a large node on her neck, above her clavicle and she also mentioned that, it's like, size of two fingers.; Swelling on lymph node; This is a spontaneous report from a contactable consumer or other non hcp. A 63-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection, Batch/Lot Number: unknown), via an unspecified route of administration in left upper arm on 04Jul2021 as dose 1, single for COVID-19 immunisation.  Medical history included thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included Levothyroxine (Levothyroxine):(103 mcg, one tablet is 100, well, 0.100 mg); taken for thyroid disorder, start and stop date were not reported.  The patient stated she got the vaccine 3 days ago and this is the first dose and after the first dose she felt very achy and just the day, she noticed that, there is a large node on her neck, above her clavicle and she also mentioned that, it's like, size of two fingers on 05Jul2021, swelling on lymph node on 05Jul2021, Patient had severe back pain like achiness, like the flu but it wasn't that's all, it was not, it went to her neck down to waist that was very bad on 06Jul2021. Consumer stated, "Just, she just want to know, Is that normal to have that swelling on lymph node. Consumer stated, "Yesterday, she had severe back pain like achiness, like the flu but it wasn't that's all, it was not, it went to her neck down to waist that is very bad. Yesterday 4 o' clock on and then today, about around 6 o clock her back started hurting again and then patient putting hands on neck, she noticed that was big one for neck." Therapeutic measures were taken with Ibuprofen and Naproxen 220 milligrams took last night 200 milligrams as a result of event she felt very achy and just the day, she noticed that, there is a large node on her neck, above her clavicle and she also mentioned that, it's like, size of two fingers, swelling on lymph node, patient had severe back pain like achiness, like the flu but it wasn't that's all, it was not, it went to her neck down to waist that is very bad. No prior to vaccinations (within 4 week). The outcome of events was unknown.  Information about lot/Batch was requested.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm has been really sore; This is a spontaneous report from a contactable consumer or other non hcp.   A 61-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), via an unspecified route of administration, administered in Arm Left on 08Jul2021 08:00 (Batch/Lot Number: EW0158) as dose 2, single (age at vaccination 61-year-old) for covid-19 immunisation. Medical history included, she had bubbles, like pockets in her arm from an unknown. The patient's concomitant medications were not reported. Patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/lot number EW0165), via on an unspecified routed of administration, administered at left arm on 17Jun2021, administration site (age at vaccination 61-year-old) for covid-19 Immunization and patient did not have a reaction with the first dose. It was reported, Caller received her second dose of the Pfizer COVID vaccine on 08Jul2021. Caller states after receiving the second dose her arm has been really sore. Caller would like to know how long this tends to last. Caller would like to know what she should do if the pain gets really bad? Caller states she had no issues with the first dose, and everything was fine. Caller would like to know if because in the past she got pockets that had encapsulated from other vaccines if she should have gotten the Pfizer COVID vaccine both doses in the same arm? Caller states she received both doses in her left arm and they were given in the same spot. She had the second dose in the same arm. Caller was unsure if she should have it in the same arm. She had vaccines and it was like she had bubbles under her skin. It had encapsulated under the skin. This was a long time ago when you had booster shots. She can still feel the knots. The outcome for event was unknown.  Follow-up actions are needed. Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: numbness in hands and legs; 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), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported), dose number unknown, at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced numbness in hands and legs on an unspecified date. The event outcome was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.