chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 50 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose number unknown, manufacturer unknown), for Covid-19 immunisation. The following information was reported: HEADACHE (non-serious), outcome "recovered", described as "50 yo male with headache"; PAIN (non-serious), outcome "recovered", described as "body ache"; FATIGUE (non-serious), outcome "recovered", described as "fatigue"; CHILLS (non-serious), outcome "recovered", described as "chills". Additional information: It was reported that 50 yo male with headache, body ache, fatigue, and chills the day after booster dose. Symptoms resolved approximately 36 hours after booster Booster dose 8 months after primary series. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: severe back muscle spasms; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCLE SPASMS (non-serious), outcome "unknown", described as "severe back muscle spasms". Additional information: Patient had severe back muscle spasms post dose 1. Event took place after use of product.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered", described as "sore arm". Therapeutic measures were taken as a result of pain in extremity.  Additional information: It was reported that i took both of the Pfizer Covid shots. I experienced a sore arm after the vaccination. I  was took two Tylenol tablets and the pain went away. I am receiving my Covid booster shot today.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Injection site erythema, Neuralgia, Pain in extremity, Poor quality product administered
Clinical narrative: No side effects from the vaccines, other than her arm being sore; Nerve pain near and above the injection site, on her left arm, left elbow, and fingers of left hand and left side of her face.; Tightness on the left arm near the secondary red area; Left arm is still warm; Vaccine was out of the refrigerator for 12-13 hours before given to the caller; Vaccine was out of the refrigerator for 12-13 hours before given to the caller; Vaccine was out of the refrigerator for 12-13 hours before given to the caller; red spot at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101625221 (Pfizer).  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 11:00 (Lot number: FJ1611) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU taken for immunisation, administration date 17Nov2021. Vaccination history included: Shingrix (first dose of the Shingrix Vaccine), administration date: 22Sep2021; Bnt162b2 (Dose:1, Batch/Lot No:EW0169, Anatomical location: Left arm), administration date: 15Apr2021, when the patient was 63 years old, for Covid-19 immunization; Bnt162b2 (Dose:2, Batch/Lot No:EW0169, Anatomical location: Left arm), administration date: 06May2021, when the patient was 63 years old, for Covid-19 immunization.  The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT STORAGE ERROR (non-serious), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) all with onset 17Nov2021, outcome "unknown" and all described as "Vaccine was out of the refrigerator for 12-13 hours before given to the caller"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "No side effects from the vaccines, other than her arm being sore"; FEELING HOT (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Left arm is still warm"; NEURALGIA (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Nerve pain near and above the injection site, on her left arm, left elbow, and fingers of left hand and left side of her face."; INJECTION SITE ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "red spot at the injection site"; SKIN TIGHTNESS (non-serious) with onset 19Nov2021, outcome "unknown", described as "Tightness on the left arm near the secondary red area". The event "vaccine was out of the refrigerator for 12-13 hours before given to the caller" was evaluated at the emergency room visit.  No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Product storage error, Skin tightness, Wrong technique in product usage process
Clinical narrative: No side effects from the vaccines, other than her arm being sore; Nerve pain near and above the injection site, on her left arm, left elbow, and fingers of left hand and left side of her face.; Tightness on the left arm near the secondary red area; Left arm is still warm; Vaccine was out of the refrigerator for 12-13 hours before given to the caller; Vaccine was out of the refrigerator for 12-13 hours before given to the caller; Vaccine was out of the refrigerator for 12-13 hours before given to the caller; red spot at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101625221 (Pfizer).  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 11:00 (Lot number: FJ1611) at the age of 64 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU taken for immunisation, administration date 17Nov2021. Vaccination history included: Shingrix (first dose of the Shingrix Vaccine), administration date: 22Sep2021; Bnt162b2 (Dose:1, Batch/Lot No:EW0169, Anatomical location: Left arm), administration date: 15Apr2021, when the patient was 63 years old, for Covid-19 immunization; Bnt162b2 (Dose:2, Batch/Lot No:EW0169, Anatomical location: Left arm), administration date: 06May2021, when the patient was 63 years old, for Covid-19 immunization.  The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT STORAGE ERROR (non-serious), WRONG TECHNIQUE IN PRODUCT USAGE PROCESS (non-serious) all with onset 17Nov2021, outcome "unknown" and all described as "Vaccine was out of the refrigerator for 12-13 hours before given to the caller"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "No side effects from the vaccines, other than her arm being sore"; FEELING HOT (non-serious) with onset 17Nov2021, outcome "not recovered", described as "Left arm is still warm"; NEURALGIA (non-serious) with onset 19Nov2021, outcome "not recovered", described as "Nerve pain near and above the injection site, on her left arm, left elbow, and fingers of left hand and left side of her face."; INJECTION SITE ERYTHEMA (non-serious) with onset 2021, outcome "unknown", described as "red spot at the injection site"; SKIN TIGHTNESS (non-serious) with onset 19Nov2021, outcome "unknown", described as "Tightness on the left arm near the secondary red area". The event "vaccine was out of the refrigerator for 12-13 hours before given to the caller" was evaluated at the emergency room visit.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Facial pain, Feeling abnormal, Rash, Rash macular
Clinical narrative: Felt like acid coming out of the pores; very red and burning with spots; very red and burning with spots; sever face pain then a rash; sever face pain then a rash; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional). The reporter is the patient. A 55-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28Oct2021 07:15 (Lot number: 2590) at the age of 55 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: FACIAL PAIN (non-serious), RASH (non-serious) all with onset 30Oct2021, outcome "recovered" (04Nov2021) and all described as "sever face pain then a rash", FEELING ABNORMAL (non-serious) with onset 31Oct2021, outcome "recovered" (06Nov2021), described as "Felt like acid coming out of the pores" RASH MACULAR (non-serious), BURNING SENSATION (non-serious) all with onset 30Oct2021, outcome "recovered" (04Nov2021) and all described as "very red and burning with spots". Therapeutic measures were not taken as a result of facial pain, rash, feeling abnormal, rash macular, burning sensation.  Additional information: The patient was no COVID, prior vaccination and not tested positive for COVID post vaccination. The patient had no known allergies. The patient stated that Extreme rash on face, very red and burning with spots. she could not go out in public. Why her face got wet i.e. show, it would significantly escalate the redness and pain. It felt like acid was coming out of her pores. Patient received vaccine Facility in Doctor's office/urgent care.  Follow-up attempts are completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 73 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 18Nov2021 (Batch/Lot number: unknown) at the age of 73 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU VACCINE VII), administration date 18Nov2021 (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False,, Prev dose lot unknown=True, Prev dose lot unknown reason=Not available/provided to reporter at the time of report completion, Prev dose administration date=Mar/2021, Prev dose dose number=1), administration date: Mar2021, for Covid-19 immunization; Bnt162b2 (Prev dose product=COVID 19, Prev dose brand=Pfizer, Prev dose brand unknown=False,, Prev dose lot unknown=True, Prev dose lot unknown reason=Not available/provided to reporter at the time of report completion, Prev dose administration date=Mar/2021, Prev dose dose number=2), administration date: Mar2021, for Covid-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 21Nov2021, outcome "recovered", described as "fatigue". Therapeutic measures were not taken as a result of fatigue.  Additional information: It was unknown if patient had a covid prior vaccination. It was unknown if patient was covid tested post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be available despite the follow-up attempts made. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder
Clinical narrative: burnt rubber taste and smell (both); burnt rubber taste and smell (both); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Nov2021 14:30 (Lot number: EW0217) at the age of 36 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Endometriosis", start date: 2018 (unspecified if ongoing); "Covid" (unspecified if ongoing), notes: if_covid_prior_vaccination Yes. The patient took concomitant medications. Past drug history included: Ceclor - when i was a baby i got a rash, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0217, Location of injection: Arm Right, Vaccine Administration Time: 03:00 PM), administration date: 13Oct2021, when the patient was 36 years old, for Covid-19 immunization. The following information was reported: TASTE DISORDER (non-serious), PAROSMIA (non-serious) all with onset 12Nov2021 18:30, outcome "not recovered" and all described as "burnt rubber taste and smell (both)". Therapeutic measures were not taken as a result of taste disorder, parosmia.  Additional Information: On 12Nov the patient had a kale salad and thought it tasted strange, like rubber. At the time she thought it was just the taste of kale, because I'd never had raw kale before. But since then, she had noticed the same very weird burnt rubber taste and smell (both) whenever she had coffee, white wine, kale, turkey, and a few other foods, those were just the ones she was most certain about because she drink coffee every day and have wine a few times a week. She had never tasted or smelled this particular taste/smell before and was concerned that it was parosmia from the vaccine. It had not gone away yet as of today 21Nov2021. There was no other vaccine in four weeks. The other medications in two weeks includes women's multi vitamin, probiotic qummy, fish oil. She had covid prior vaccination. And post vaccination not tested for covid. The known allergies includes ceclor, when I was a baby I got Rash. Other medical history includes endometriosis since 2018 / UTI (I got this 16 days after the first dose of the vaccine and it took 23 days to go away also concerned that was from the vaccine)  No follow-up attempts are possible. No further information is expected
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: Achiness; Feel achy; Chills; Headache; I feel tired/fatigue; I am not having much energy as I normally would; Felt kind of really bad as if I am coming down with the flu; I felt cold; Felt kind of really bad as if I am coming down with the flu; I felt cold; Felt kind of really bad as if I am coming down with the flu; I felt cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Lot number: FH8027) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 01Nov2021. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 Immunization; Bnt162b2 (2nd Dose), for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "Achiness; Feel achy"; CHILLS (non-serious) with onset Nov2021, outcome "unknown", described as "Chills"; HEADACHE (non-serious) with onset Nov2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "I feel tired/fatigue"; ASTHENIA (non-serious) with onset Nov2021, outcome "unknown", described as "I am not having much energy as I normally would"; FEELING ABNORMAL (non-serious), INFLUENZA LIKE ILLNESS (non-serious), FEELING COLD (non-serious) all with onset Nov2021, outcome "unknown" and all described as "Felt kind of really bad as if I am coming down with the flu; I felt cold". Therapeutic measures were taken as a result of headache, fatigue.  Additional Information: The patient was calling in today because as had the Pfizer booster shot this past Friday and the patient just experiencing some side effects like achiness, chills, headache and everything as if it was coming down with the cold or flu, like tiredness, fatigue and the patient not having much energy as normally would. So, the patients husband the patient were reading that those are some side effects and you just have to just take Tylenol and see how long, if it is lasting too long, go to urgent care or something. Actually, started like on Friday, had a headache and yesterday, did go out and do some errands, The patient came back home and felt kind of really bad as if the patient was coming down with the flu and then this morning, the same thing, felt tired and just feel achy, don't feel too good, don't really look too good either.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pain
Clinical narrative: Achiness; Feel achy; Chills; Headache; I feel tired/fatigue; I am not having much energy as I normally would; Felt kind of really bad as if I am coming down with the flu; I felt cold; Felt kind of really bad as if I am coming down with the flu; I felt cold; Felt kind of really bad as if I am coming down with the flu; I felt cold; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administration date 19Nov2021 (Lot number: FH8027) at the age of 57 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII, administration date 01Nov2021. Vaccination history included: Bnt162b2 (1st Dose), for Covid-19 Immunization; Bnt162b2 (2nd Dose), for Covid-19 Immunization. The following information was reported: PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "Achiness; Feel achy"; CHILLS (non-serious) with onset Nov2021, outcome "unknown", described as "Chills"; HEADACHE (non-serious) with onset Nov2021, outcome "unknown", described as "Headache"; FATIGUE (non-serious) with onset Nov2021, outcome "unknown", described as "I feel tired/fatigue"; ASTHENIA (non-serious) with onset Nov2021, outcome "unknown", described as "I am not having much energy as I normally would"; FEELING ABNORMAL (non-serious), INFLUENZA LIKE ILLNESS (non-serious), FEELING COLD (non-serious) all with onset Nov2021, outcome "unknown" and all described as "Felt kind of really bad as if I am coming down with the flu; I felt cold". Therapeutic measures were taken as a result of headache, fatigue.  Additional Information: The patient was calling in today because as had the Pfizer booster shot this past Friday and the patient just experiencing some side effects like achiness, chills, headache and everything as if it was coming down with the cold or flu, like tiredness, fatigue and the patient not having much energy as normally would. So, the patients husband the patient were reading that those are some side effects and you just have to just take Tylenol and see how long, if it is lasting too long, go to urgent care or something. Actually, started like on Friday, had a headache and yesterday, did go out and do some errands, The patient came back home and felt kind of really bad as if the patient was coming down with the flu and then this morning, the same thing, felt tired and just feel achy, don't feel too good, don't really look too good either.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Mammogram abnormal
Clinical narrative: abnormal mammogram; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MAMMOGRAM ABNORMAL (non-serious), outcome "unknown", described as "abnormal mammogram". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone, Blood thyroid stimulating hormone increased
Clinical narrative: She has got high TSH; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent. This consumer (patient's mother) reported for a female patient (daughter) that:  A 17 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BLOOD THYROID STIMULATING HORMONE INCREASED (non-serious), outcome "unknown", described as "She has got high TSH". Relevant laboratory tests and procedures are available in the appropriate section, which included TSH, results: increase (She has got high TSH).   Additional information: Reported tried to find out information on, her daughter got the Covid vaccine and months later now, has a thyroid disorder. She was only 16 when she got it and 17 now (not clarified further), and she didn't have any problems. Now, she has got high TSH and all sort of stuff. So, she was just checking to see if there is any kind of studies or any information I can get on whether or not the vaccine, not having Covid but the vaccine may contribute to that.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: nausea; vomiting; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 7-year-old female patient received bnt162b2 (COMIRNATY), administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 7 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NAUSEA (non-serious) with onset Nov2021, outcome "unknown", described as "nausea"; VOMITING (non-serious) with onset Nov2021, outcome "unknown", described as "vomiting"; DIARRHOEA (non-serious) with onset Nov2021, outcome "unknown", described as "diarrhea".  Additional information: The reporting parent stated that her daughter received the Pfizer vaccine on Saturday and has presented vomiting and diarrhea. She vomited 4 times, diarrhea does not go away because she went to the bathroom 3 times, she has nausea and vomiting. She wants to know if these are common or normal side effects caused by the vaccine. Reporter stated that she trust what they are studying the vaccine for something good. Reporter stated that her other two children, 9 and 11 years of age, had no side effects, but daughter did have a reaction to the vaccines. She spoke more than anything because her doctor told to talk to company to see if it was normal and in response, she was suggested to visit the website  for further information about the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 9.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: Face is swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 9 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 9 years as dose number unknown (tris), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications.  The following information was reported: SWELLING FACE (non-serious) with onset 21Nov2021, outcome "unknown", described as "Face is swollen". Therapeutic measures were taken as a result of swelling face.  Additional information: Reporter stated that the patient (daughter) got a shot yesterday, she is 9-year-old and her face is swollen today. Reporter stated that patient received some Tylenol yesterday and Benadryl in case of allergic reaction before she went to bed. So, Benadryl, single tablet 25 mg and 500 mg Tylenol in case if she got like fever to it." (further clarification unknown if patient was experiencing allergic reaction and fever, hence allergic reaction and fever not captured as events).  Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: After 2nd dose, large rash on chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  An adult male patient received bnt162b2 (COMIRNATY), administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Cominarty (prev dose product: COVID 19, prev dose brand: Cominarty, prev dose brand unknown: False, prev dose lot unknown: True, prev dose lot unknown reason: Not available/provided to reporter at the time of report completion, prev dose number: 1), for Covid-19 immunization, reaction(s): "severe flu like symptoms". The following information was reported: RASH (non-serious) with onset 2021, outcome "recovered" (2021), described as "After 2nd dose, large rash on chest". It was unknown if therapeutic measures were taken as a result of rash.  Additional information: It was unknown if other vaccine within four weeks. It was unknown if covid was prior vaccination and If covid tested post vaccination.  Follow-up attempts completed. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Only had soreness which is normally the same reaction she gets with the flu shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient received bnt162b2 (BNT162B2), administration date 01Feb2021 (Lot number: NM5318) as dose 1, single and administration date 22Feb2021 (Lot number: EN6201) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing), notes: Hypothyroidism; "Blood pressure high" (unspecified if ongoing), notes: Blood pressure high; "Allergy" (unspecified if ongoing), notes: Additional Information for Other Conditions: gets hives; "COPD" (unspecified if ongoing); "Extreme arthritis/ severe arthritis in her neck" (unspecified if ongoing), notes: she has severe arthritis in her neck which started before she got any of the, doses of the vaccine; "Hives" (unspecified if ongoing), notes: Additional Information for Other Conditions: gets hives. The patient's concomitant medications were not reported. Vaccination history included: Typhoid vaccine (she had problems after having the Typhoid vaccine). The following information was reported: PAIN (non-serious) with onset Feb2021, outcome "unknown", described as "Only had soreness which is normally the same reaction she gets with the flu shot". Additional Information: The patient had the first 2 shots in Feb2021, and since she was in an area of withheld where Covid was more aggressive she wanted to get the booster, so she got it on Monday at around 1pm. States that she didn't have much of a reaction to the 1st 2 shots; she only had soreness which was normally the same reaction she gets with the flu shot.   No follow-up attempts are possible. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Gait disturbance, Headache, Myalgia
Clinical narrative: body ache; chills; tiredness; hard to walk; muscle pain; headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 17:45 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 20Nov2021 15:00, outcome "recovered" (2021), described as "body ache"; CHILLS (non-serious) with onset 20Nov2021 15:00, outcome "recovered" (2021), described as "chills"; FATIGUE (non-serious) with onset 20Nov2021 15:00, outcome "recovered" (2021), described as "tiredness"; GAIT DISTURBANCE (non-serious) with onset 20Nov2021 15:00, outcome "recovered" (2021), described as "hard to walk"; MYALGIA (non-serious) with onset 20Nov2021 15:00, outcome "recovered" (2021), described as "muscle pain"; HEADACHE (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "headaches". Therapeutic measures were taken as a result of pain, chills, fatigue, gait disturbance, myalgia, headache.  Additional information: Seriousness criteria reported as No. No structured information (Patient episode name). After 24 hours of shot patient start to have body aches, chills & tiredness, at one point it was hard to walk due to muscle pain, headaches started 48 hours after. No Hospitalization Prolonged. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient has not been tested for COVID-19. The treatment received for the adverse event was Tylenol.  Follow-up attempts completed. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: body ache; chills; tiredness; hard to walk; muscle pain; headaches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 17:45 (Batch/Lot number: unknown) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: PAIN (non-serious) with onset 20Nov2021 15:00, outcome "recovered" (2021), described as "body ache"; CHILLS (non-serious) with onset 20Nov2021 15:00, outcome "recovered" (2021), described as "chills"; FATIGUE (non-serious) with onset 20Nov2021 15:00, outcome "recovered" (2021), described as "tiredness"; GAIT DISTURBANCE (non-serious) with onset 20Nov2021 15:00, outcome "recovered" (2021), described as "hard to walk"; MYALGIA (non-serious) with onset 20Nov2021 15:00, outcome "recovered" (2021), described as "muscle pain"; HEADACHE (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "headaches". Therapeutic measures were taken as a result of pain, chills, fatigue, gait disturbance, myalgia, headache.  Additional information: Seriousness criteria reported as No. No structured information (Patient episode name). After 24 hours of shot patient start to have body aches, chills & tiredness, at one point it was hard to walk due to muscle pain, headaches started 48 hours after. No Hospitalization Prolonged. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination patient has not been tested for COVID-19. The treatment received for the adverse event was Tylenol.  Follow-up attempts completed. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tired after second vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 67-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 (Batch/Lot number: unknown) at the age of 67 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "oral surgery", start date: Mar2020, stop date: Mar2020, notes: oral surgery in Mar2020 and was not able to eat because of the surgery. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, Lot: EN6199, Expiry Date of Covid vaccine: Unknown, Site: Caller thinks right arm, first vaccine she had no problem), administration date: 08Mar2021, when the patient was 67 years old, for Covid-19 Immunization, reaction(s): "No reaction on previous exposure to vaccine".  The following information was reported: FATIGUE (non-serious) with onset 2021, outcome "recovered" (2021), described as "Tired after second vaccine".  Additional information: Reporter was a lab technician, stated that first vaccine she had no problem, and the second vaccine, she was tired. Caller explained that she had elective oral surgery in Mar2020 and was not able to eat because of the surgery and could not keep up her nutrition without her original teeth. The patient was Tired after second vaccine, ended within 24 hours. Facility where patient received vaccine was Covid clinic, hospital. The patient not received vaccine at a Facility. No Additional Vaccines Administered on Same Date of the Pfizer Suspect. The patient did not require to visit Emergency Room/Physician Office. No other vaccinations administered within four weeks prior to the first administration date of the suspect vaccine. No AE(s) following prior vaccinations. The patient had no medical History (including any illness at time of vaccination). Family Medical History Relevant to AE(s) was not provided. The patient had no relevant Tests.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site pain
Clinical narrative: She had that with the first two vaccines at the injection site in the arm. With the first two vaccines she had pain in left arm.; She had that with the first two vaccines at the injection site in the arm. With the first two vaccines she had pain in left arm.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single and administered in arm left, administration date May2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "recovering" and all described as "She had that with the first two vaccines at the injection site in the arm. With the first two vaccines she had pain in left arm.". Therapeutic measures were taken as a result of vaccination site pain, pain in extremity.  Additional information: It was reported, the patient was calling about Pfizer COVID vaccine booster shot. She had it last done last Monday, 15Nov. She woke up two days later and her left toe and the bones on the front of her foot were swollen. She didn't know she would get that side effect. She had been in and out of a headache. She would have a headache for a few minutes and it would come and go. She had a swollen tongue and tightness of chest. She could hardly breathe. She had shortness of breath, runny nose, and a slight decrease in appetite. The hardest thing was the big fat swollen tongue and the swelling of left big toe and the bone structure on the front of the foot. She got severe pain in her arm at the injection site. She had that all day on Tuesday and thought it was normal. She had that with the first two vaccines at the injection site in the arm. She thought that would go away. She took tablets and was getting better. She could hardly breathe on Wednesday. Her big toe was swollen and she had wicked sore bone and joints. She is ok now and it went back to normal. In April and May caller got the first two vaccines.  Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dental discomfort, Oropharyngeal discomfort, Pain in jaw
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. A 70 year-old female patient received bnt162b2 (BNT162B2), administration date 07Oct2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE NUMBER UNKNOWN, "Primary Immunization series complete. Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: PAIN IN JAW (non-serious), DENTAL DISCOMFORT (non-serious), OROPHARYNGEAL DISCOMFORT (non-serious), outcome "unknown" and all described as "Pressure/She was having the same symptoms of her jaw, teeth, and throat". Clinical course: The patient received the booster dose on 07Oct2021 and since then she was not seen a well day since. Caller stated she has experienced pressure in the neck area very close to the Eustachian tube in the top of the mouth and it comes and last three minutes and then it will slowly dissipate and sometimes it will be followed by another episode immediately. She experienced the pressure within a week after the booster. It was all over the place. It rises and builds. She could feel it in the back of the throat. Caller stated that 99% of people she spoke to do not have anything more than a sore arm after receiving the vaccine and she only heard of two other people that have had side effects similar to hers. Caller stated she has been to three doctors and they don't know what was going on or what to do about it and this was serious because she doesn't know what to do. Caller also stated she was allergic. Caller stated she had a reaction to the withheld over 20 years ago. Caller stated her reaction for the withheld included a lot muscle aches where she couldn't even walk without holding on to stuff throughout the house and she had a fine rash on both arms. No information in PI regarding episodes of pressure in neck that comes and goes. Caller states she was not sure if there is something in the booster dose that contains these. Caller states her doctors will not take the time to compare the ingredients. Informed caller that actin is not listed as an ingredient in the PI and Boniva is not manufactured by Pfizer but I can send her a list of ingredients of the vaccine and she can take them to her pharmacist or doctor to have them compare the ingredients to the medication she is allergic to see if any ingredients crossover. She has been to numerous doctors that say it sounds like the shot. She was having the same symptoms of her jaw, teeth, and throat. Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort
Clinical narrative: Periencing pressure in the neck area; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MUSCULOSKELETAL DISCOMFORT (non-serious), outcome "unknown", described as "Periencing pressure in the neck area".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives/ left arm, part of her outer knee area of her left leg, and back left side of neck broke out with little tiny hives; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 57 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 03Nov2021 17:30 (Batch/Lot number: unknown) at the age of 57 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported.  The following information was reported: URTICARIA (non-serious) with onset Nov2021, outcome "recovering", described as "Hives/ left arm, part of her outer knee area of her left leg, and back left side of neck broke out with little tiny hives".  Additional information: The caller confirms she was not a healthcare professional but she works at (Withheld) Pharmaceuticals. The caller was calling in regards to her COVID-19 vaccination, the first one. She mentions she had spoke with the lady who was going to give the caller her second vaccination and asked if she had heard anybody who broke out with hives after the vaccine. The caller explains her left arm and part of her outer knee area of her left leg broke out with little tiny hives. She also broke out on her arms. Within the last 5 days, she started getting hives on the back left side of her neck. Now, they are starting to go away. The caller asks if she can go ahead and get the second dose. She mentions her work gave her a deadline of 08Dec2021 to be fully vaccinated before they get rid of people. Healthcare Professional: Declined, stating she already spoke to her about it and her doctor said it probably could have been attributed to the vaccine, but she couldn't give a 100% confirmation. The caller clarifies she developed hives about a week after receiving the first dose, like 5 days after maybe. She confirms the hives are improving. She verifies she did have her vaccine record card but the person at (Withheld) took her card and she currently doesn't have it at the time of the call. Caller verifies she has not received her second dose yet.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Decreased appetite, Nasopharyngitis, Pain
Clinical narrative: running fever; Upset stomach; Cold chills; Cold chills; Loss of appetite; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 12:00 (Batch/Lot number: unknown) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: MIRALAX. The following information was reported: PYREXIA (non-serious) with onset 21Nov2021 01:15, outcome "not recovered", described as "running fever"; ABDOMINAL DISCOMFORT (non-serious) with onset 21Nov2021 01:15, outcome "not recovered", described as "Upset stomach"; NASOPHARYNGITIS (non-serious), CHILLS (non-serious) all with onset 21Nov2021 01:15, outcome "not recovered" and all described as "Cold chills"; DECREASED APPETITE (non-serious) with onset 21Nov2021 01:15, outcome "not recovered", described as "Loss of appetite"; PAIN (non-serious) with onset 21Nov2021 01:15, outcome "not recovered", described as "Body aches". The events "running fever", "upset stomach", "cold chills", "cold chills", "loss of appetite" and "body aches" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pyrexia, abdominal discomfort, nasopharyngitis, chills, decreased appetite, pain.  Additional information: No other vaccine in four weeks. other medications in two weeks: toddler multivitamin. No covid tested post vaccination.  Follow-up attempts completed. No further information is expected. The lot/batch number is not available despite the follow-up attempts made.
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: running fever; Upset stomach; Cold chills; Cold chills; Loss of appetite; Body aches; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 6 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 12:00 (Batch/Lot number: unknown) at the age of 6 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: MIRALAX. The following information was reported: PYREXIA (non-serious) with onset 21Nov2021 01:15, outcome "not recovered", described as "running fever"; ABDOMINAL DISCOMFORT (non-serious) with onset 21Nov2021 01:15, outcome "not recovered", described as "Upset stomach"; NASOPHARYNGITIS (non-serious), CHILLS (non-serious) all with onset 21Nov2021 01:15, outcome "not recovered" and all described as "Cold chills"; DECREASED APPETITE (non-serious) with onset 21Nov2021 01:15, outcome "not recovered", described as "Loss of appetite"; PAIN (non-serious) with onset 21Nov2021 01:15, outcome "not recovered", described as "Body aches". The events "running fever", "upset stomach", "cold chills", "cold chills", "loss of appetite" and "body aches" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pyrexia, abdominal discomfort, nasopharyngitis, chills, decreased appetite, pain.  Additional information: No other vaccine in four weeks. other medications in two weeks: toddler multivitamin. No covid tested post vaccination.  Follow-up attempts completed. No further information is expected. The lot/batch number is not available despite the follow-up attempts made.