chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Blood iron normal, Blood test, Fatigue
Clinical narrative: extreme joint aches; stiffness; weak and tired; weak and tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administration date 17Oct2021 (Lot number: FF2590) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart attack" (unspecified if ongoing), notes: Verbatim: Heart attack, The heart attack was on his 60th birthday.; "Aflutter" (unspecified if ongoing), notes: Verbatim: Aflutter; "AFib" (unspecified if ongoing), notes: Verbatim: AFib; "ablation" (unspecified if ongoing), notes: Verbatim: ablation; "hemochromatosis" (ongoing), notes: He has hemochromatosis. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (2nd dose, lot number: EL9264), administration date: 07Jul2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "first dose: given on 12Jan2021/second dose: given on 07Jul2021"; Bnt162b2 (1st dose, lot number: EL0142), administration date: 12Jan2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "first dose: given on 12Jan2021/second dose: given on 07Jul2021". The following information was reported: ARTHRALGIA (non-serious) with onset 17Oct2021, outcome "unknown", described as "extreme joint aches"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 17Oct2021, outcome "unknown", described as "stiffness"; ASTHENIA (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "unknown" and all described as "weak and tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was reported that patient and his wife had the full series of the Pfizer Covid Vaccine and the booster dose, and he and his wife had no adverse events with the first two doses but had many side effects with the booster dose and a retired Pharmaceutical Operation Officer, who want information on the device that monitors the temperature of the shipper the Pfizer Covid Vaccine was shipped in.   Follow-up attempts are completed. No further information is expected.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness
Clinical narrative: extreme joint aches; stiffness; weak and tired; weak and tired; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old male patient received bnt162b2 (BNT162B2), administration date 17Oct2021 (Lot number: FF2590) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Heart attack" (unspecified if ongoing), notes: Verbatim: Heart attack, The heart attack was on his 60th birthday.; "Aflutter" (unspecified if ongoing), notes: Verbatim: Aflutter; "AFib" (unspecified if ongoing), notes: Verbatim: AFib; "ablation" (unspecified if ongoing), notes: Verbatim: ablation; "hemochromatosis" (ongoing), notes: He has hemochromatosis. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (2nd dose, lot number: EL9264), administration date: 07Jul2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "first dose: given on 12Jan2021/second dose: given on 07Jul2021"; Bnt162b2 (1st dose, lot number: EL0142), administration date: 12Jan2021, when the patient was 67 years old, for COVID-19 immunization, reaction(s): "first dose: given on 12Jan2021/second dose: given on 07Jul2021". The following information was reported: ARTHRALGIA (non-serious) with onset 17Oct2021, outcome "unknown", described as "extreme joint aches"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 17Oct2021, outcome "unknown", described as "stiffness"; ASTHENIA (non-serious), FATIGUE (non-serious) all with onset 2021, outcome "unknown" and all described as "weak and tired". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: It was reported that patient and his wife had the full series of the Pfizer Covid Vaccine and the booster dose, and he and his wife had no adverse events with the first two doses but had many side effects with the booster dose and a retired Pharmaceutical Operation Officer, who want information on the device that monitors the temperature of the shipper the Pfizer Covid Vaccine was shipped in.   Follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Pain in extremity, Tremor
Clinical narrative: Right arm hurts, after booster; Tremors, shakes in right hand, only in the morning, after  booster; Weakness in right arm, from shoulders to fingers, after booster.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 23Oct2021 (Lot number: FP25Q) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Psoriatic arthritis" (unspecified if ongoing). Concomitant medication(s) included: MELOXICAM taken for psoriatic arthropathy (ongoing); HYDROXYCHLOROQUINE; OTEZLA; FLU VACCINE VII, start date: 13Oct2021, stop date: 13Oct2021. Vaccination history included: Bnt162b2 (Dose: 01, Time: 10:00 AM, Anatomical site of injection: Left arm, Batch number: ER8733, Exp: Jul2021), administration date: 26Mar2021, when the patient was 62 years old, for COVID-19 immunization; Bnt162b2 (Dose: 02, Time: 10:00 AM, Anatomical site of injection: Left arm, Batch number: EW0158, Exp: Jul2021), administration date: 16Apr2021, when the patient was 62 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Oct2021, outcome "recovering", described as "Right arm hurts, after booster"; TREMOR (non-serious) with onset 2021, outcome "recovering", described as "Tremors, shakes in right hand, only in the morning, after booster"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "recovering", described as "Weakness in right arm, from shoulders to fingers, after booster."  Additional information: It was reported that, lot number FP25Q or it could be FPCSQ. No emergency room, AE(s) following prior vaccinations, relevant tests and physician office. Family medical history relevant to AE(s) was not provided. The A/E was going away. Not an issue now. It was constant on and off since injection. Seems to be subsiding now.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: tinnitus; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date Mar2021 (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: TINNITUS (non-serious) with onset 2021, outcome "unknown", described as "tinnitus".  Additional information: The reporter enquired that Patient ok to restart series now, and go through both doses or should he look into the booster. If the Moderna vaccine is available, is it ok to get the Moderna vaccine or should he stick with Pfizer Covid vaccine. Has there been any link or heard of reports with tinnitus or ringing in the ear.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort
Clinical narrative: These symptoms were unlike what was experienced for the first and second doses resulting in much discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 58 years 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: DISCOMFORT (non-serious), outcome "unknown", described as "These symptoms were unlike what was experienced for the first and second doses resulting in much discomfort".  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information was expected.
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Mechanical urticaria
Clinical narrative: receiving the 1st dose of the vaccine the patient developed urticaria dermatographia on the left hip; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 23Nov2021 17:00 (Lot number: FH8027) at the age of 15 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Past drug history included: No. The following information was reported: MECHANICAL URTICARIA (non-serious) with onset 29Nov2021 19:00, outcome "not recovered", described as "receiving the 1st dose of the vaccine the patient developed urticaria dermatographia on the left hip". Therapeutic measures were not taken as a result of mechanical urticaria.  Additional information:: 6 days after receiving the 1st dose of the vaccine the patient developed urticaria dermatographia on the left hip. adverse event start date 29Nov2021. adverse event start time 07:00 PM  No follow-up attempts are possible. No further information is expected.
Age: 7.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Pyrexia, Vomiting
Clinical narrative: vomiting; Stomach ache; low grade fever (99F); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 7 year-old female patient received bnt162b2 (COMIRNATY), intramuscular, administration date 29Nov2021 18:45 (Lot number: FL0007) at the age of 7 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLUCELVAX QUADRIVALENT, administration date 21Nov2021. Vaccination history included: Comirnaty (1st dose, Time: 17:15, Lot Number: FK5127, Route: Intramuscular, Anatomical Location: Right Arm), administration date: 09Nov2021, when the patient was 7 years old, for COVID-19 immunization.  The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 30Nov2021 13:30, outcome "unknown", described as "Stomach ache"; VOMITING (non-serious) with onset 30Nov2021 15:00, outcome "unknown", described as "vomiting"; PYREXIA (non-serious) with onset 30Nov2021, outcome "unknown", described as "low grade fever (99F)". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Relevant tests and Specific Relevant tests for thromboembolic events with thrombocytopenia were None. Upon temperature check, patient had a low-grade fever of 99F on 30Nov021.  Follow-up attempts are completed. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: After receiving the 2nd dose, the cough and the lethargy were gone and he hasn't had them since. Also, his taste never went away completely; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Apr2021 (Lot number: EW0172) at the age of 48 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "COVID", start date: Dec2020 (unspecified if ongoing), notes: he got Covid in Dec2020, about 2 weeks before Christmas, so it was probably around 16Dec2020, on a Sunday. States that he woke up that morning and suddenly felt like he was going to die. He was only sick for 2 days, so by Monday night he was fine. However, he continued to have a cough and was lethargic.; "Lethargy" (unspecified if ongoing), notes: the next morning after receiving the 2nd dose, the cough and the lethargy were gone; "cough" (unspecified if ongoing), notes: the next morning after receiving the 2nd dose, the cough and the lethargy were gone. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot: EW0153, Both injections in left arm), administration date: 07Apr2021, for COVID-19 Immunization. The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 30Apr2021, outcome "unknown", described as "After receiving the 2nd dose, the cough and the lethargy were gone and he hasn't had them since. Also, his taste never went away completely".  Additional information: he got Covid in Dec2020, about 2 weeks before Christmas, so it was probably around 16Dec2020, on a Sunday. States that he woke up that morning and suddenly felt like he was going to die. He was only sick for 2 days, so by Monday night he was fine. However, he continued to have a cough and was lethargic. His taste never went away completely when he had Covid but it was greatly reduced. After getting the 2nd dose of the vaccine, his taste has come back too. When he went to get his booster today, the nurse recommended that he call and report the positive effect of the vaccine because it cleared his cough and lethargy. States that he felt like he was a new human being. His first thought was, man I love this Pfizer vaccine. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no adverse event following prior vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Bruising on legs; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 35 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Oct2021 (Lot number: FF2589) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Low Potassium" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Cipro, reaction(s): "Allergy: Cipro". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: UJ724AA, Location of injection: Arm Left), administration date: 02Oct2021, when the patient was 35 years old, for Covid-19 Immunization. The following information was reported: CONTUSION (non-serious) with onset 15Nov2021, outcome "recovered" (2021), described as "Bruising on legs". It was unknown if therapeutic measures were taken as a result of contusion. Additional information: The patient not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient had not been tested for COVID-19.  No follow-up at tempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache
Clinical narrative: Headache; Chills; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 56 year-old female patient received bnt162b2 (BNT162B2), administration date 21Feb2021 (Lot number: EN5318) at the age of 56 years as dose 2, single and administration date 31Jan2021 (Lot number: EL3247) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Pulmonary embolism" (unspecified if ongoing), notes: Recurrent Pulmonary embolism. Concomitant medication(s) included: XARELTO taken for pulmonary embolism. The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "unknown", described as "Headache"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "Chills".  Additional information: Prior vaccinations (within 4 weeks): none.  No follow-up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s) : US-PFIZER INC-202101699575 same patient/drug, different event (Booster dose).
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Nasal congestion, Pain, Pyrexia
Clinical narrative: Flu like symptoms including; Fever; Aches; Chills; Congestion that lasted 1-2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administration date 17Feb2021 (Lot number: EN5318) at the age of 35 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anxiety" (ongoing), notes: Verbatim: Anxiety. Concomitant medication(s) included: RISPERDAL taken for anxiety (ongoing). Vaccination history included: Bnt162b2 (1st dose , Lot: EN5318,, His first 2 doses were administered at the local hospital), administration date: 27Jan2021, when the patient was 35 years old, for COVID-19 Immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Flu like symptoms including"; PYREXIA (non-serious) with onset 2021, outcome "recovered" (2021), described as "Fever"; PAIN (non-serious) with onset 2021, outcome "recovered" (2021), described as "Aches"; CHILLS (non-serious) with onset 2021, outcome "recovered" (2021), described as "Chills"; NASAL CONGESTION (non-serious) with onset 2021, outcome "recovered" (2021), described as "Congestion that lasted 1-2 days".  No follow-up attempts are possible. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: A bit of pain in both of his leg one in particular from his thigh all the way down to his calf; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 8 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 15:30 (Lot number: FK5127) at the age of 8 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose: 1, Lot number: FK5618, Anatomical site: was on his left arm below his shoulder.), administration date: 08Nov2021, when the patient was 8 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 29Nov2021, outcome "not recovered", described as "A bit of pain in both of his leg one in particular from his thigh all the way down to his calf". Therapeutic measures were not taken as a result of pain in extremity.  Additional Information: Reporter stated, My son had his second Pfizer shot today at about what time was it, probably about 3:30 today and he is now having quite a bit of pain in both of his leg one in particular from his thigh all the way down to his calf and that is it. So, I am calling to report. When paraphrased the concern, reporter stated, "Yes, one in particular is very painful and he is 8 years old. still experiencing the problem, reporter stated, as Yes. Outcome of Event (Worsened, improved, persisting): Reporter stated, It I just same not worse it's just kind of holding. Prior vaccination (Within four weeks) Reporter stated as No.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Pneumonitis
Clinical narrative: Having inflammation in her lungs; difficulty breathing; 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 female patient in her 70's received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "metastatic breast cancer" (unspecified if ongoing), notes: 70's and has metastatic breast cancer that is in her lungs along with  other places. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 01), for COVID-19 immunization; Bnt162b2 (Dose 02), for COVID-19 immunization. The following information was reported: PNEUMONITIS (non-serious), outcome "unknown", described as "Having inflammation in her lungs"; DYSPNOEA (non-serious), outcome "unknown", described as "difficulty breathing".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 64.0
Sex: F
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 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 04May2021 (Lot number: EW0167) at the age of 64 years as dose 1, single and administered in arm left, administration date 25May2021 09:00 (Lot number: EW0185) 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) with onset May2021, outcome "unknown", described as "Sore arm".  Additional Information: Patient was not taken any other vaccination in four weeks. Patient had not tested for COVID-19 before and after vaccination.  No follow-up attempts are possible. No further information is expected.  Follow-Up (02Dec2021): Follow-up attempts are completed. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: fatigue; H/A; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Apr2021 14:30 (Lot number: EB8733, Expiration Date: 31Jul2021) at the age of 65 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "hyperthyroidism" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hyperthyroidism, start date: Oct2002 (ongoing). Vaccination history included: Bnt162b2 (First dose-, Lot/batch no: EL9267, administration time=13:30, vaccine_location= left upper arm, Route- intramuscular, Expiry date - 31May2021, NDC: 59267-1000-1), administration date: 15Mar2021, for COVID-19 immunization. The following information was reported: FATIGUE (non-serious) with onset 08Apr2021, outcome "unknown", described as "fatigue"; HEADACHE (non-serious) with onset 08Apr2021, outcome "unknown", described as "H/A".  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Glycosylated haemoglobin increased, Illness, Limb discomfort, Nodule
Clinical narrative: Elevated A1C; COVID arm; Sick for like 3 weeks; Knot in her arm for 3 weeks; COVID arm with swelling; Fever; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 08Nov2021 15:00 (Lot number: FH8027) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing); "obesity" (unspecified if ongoing); "prediabetic" (unspecified if ongoing), notes: she has been prediabetic for several years now. She said her numbers were at a 6 for several years. There were no concomitant medications. The following information was reported: GLYCOSYLATED HAEMOGLOBIN INCREASED (non-serious) with onset 09Nov2021, outcome "not recovered", described as "Elevated A1C"; LIMB DISCOMFORT (non-serious) with onset 09Nov2021, outcome "unknown", described as "COVID arm"; ILLNESS (non-serious) with onset 09Nov2021, outcome "recovered" (Nov2021), described as "Sick for like 3 weeks"; NODULE (non-serious) with onset 09Nov2021, outcome "recovered" (2021), described as "Knot in her arm for 3 weeks"; PERIPHERAL SWELLING (non-serious) with onset 09Nov2021, outcome "unknown", described as "COVID arm with swelling"; PYREXIA (non-serious) with onset Nov2021, outcome "unknown", described as "Fever". The events "elevated a1c", "covid arm", "sick for like 3 weeks", "knot in her arm for 3 weeks", "covid arm with swelling" and "fever" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: A caller stated that she had her first dose of covid adult vaccine on 08Nov at her left arm. She had COVID arm with swelling, she had a fever and was sick for like 3 weeks. She had a knot in her arm for 3 weeks. She went to the doctor, and he checked her blood work. Her A1C levels were elevated was the only thing he could find. They have been monitoring it for the last 5 years. She is calling about the COVID vaccine. The first dose was on 08Nov2021, given in her Left arm, around 3pm. Her second one was given 30Nov2021 with lot FF2593, in her left arm, around 2pm. She didn't get it for any particular reason. After the first dose is when she experienced all of these side effects. Her A1C is still elevated. 54-year-old female said she has been prediabetic for several years now. She said her numbers were at a 6 for several years. Then after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, her A1C levels became elevated. Patient wants to know if this is normal.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Elevated A1C; COVID arm; Sick for like 3 weeks; Knot in her arm for 3 weeks; COVID arm with swelling; Fever; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 54 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 08Nov2021 15:00 (Lot number: FH8027) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergies" (unspecified if ongoing); "obesity" (unspecified if ongoing); "prediabetic" (unspecified if ongoing), notes: she has been prediabetic for several years now. She said her numbers were at a 6 for several years. There were no concomitant medications. The following information was reported: GLYCOSYLATED HAEMOGLOBIN INCREASED (non-serious) with onset 09Nov2021, outcome "not recovered", described as "Elevated A1C"; LIMB DISCOMFORT (non-serious) with onset 09Nov2021, outcome "unknown", described as "COVID arm"; ILLNESS (non-serious) with onset 09Nov2021, outcome "recovered" (Nov2021), described as "Sick for like 3 weeks"; NODULE (non-serious) with onset 09Nov2021, outcome "recovered" (2021), described as "Knot in her arm for 3 weeks"; PERIPHERAL SWELLING (non-serious) with onset 09Nov2021, outcome "unknown", described as "COVID arm with swelling"; PYREXIA (non-serious) with onset Nov2021, outcome "unknown", described as "Fever". The events "elevated a1c", "covid arm", "sick for like 3 weeks", "knot in her arm for 3 weeks", "covid arm with swelling" and "fever" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: A caller stated that she had her first dose of covid adult vaccine on 08Nov at her left arm. She had COVID arm with swelling, she had a fever and was sick for like 3 weeks. She had a knot in her arm for 3 weeks. She went to the doctor, and he checked her blood work. Her A1C levels were elevated was the only thing he could find. They have been monitoring it for the last 5 years. She is calling about the COVID vaccine. The first dose was on 08Nov2021, given in her Left arm, around 3pm. Her second one was given 30Nov2021 with lot FF2593, in her left arm, around 2pm. She didn't get it for any particular reason. After the first dose is when she experienced all of these side effects. Her A1C is still elevated. 54-year-old female said she has been prediabetic for several years now. She said her numbers were at a 6 for several years. Then after receiving the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine, her A1C levels became elevated. Patient wants to know if this is normal.  No follow-up attempts are possible. No further information is expected.
Age: 8.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 8 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 29Nov2021 07:00 (Lot number: FL0007) at the age of 8 years as dose 2 (tris), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 13Nov2021. Vaccination history included: Bnt162b2 (dose 1 (tris), single, administration time=07:00, vaccine location=Left arm, lot number=FK5127), administration date: 08Nov2021, when the patient was 8 years old, for COVID-19 immunization. The following information was reported: VOMITING (non-serious) with onset 01Dec2021 07:00, outcome "recovering", described as "Vomiting". The event "vomiting" was evaluated at the physician office visit. Therapeutic measures were taken as a result of vomiting.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 48 hours after vaccination child was vomiting. Doctor prescribed nausea meds as treatment for the adverse event.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Nausea
Clinical narrative: This is a spontaneous report received from a noncontactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A female patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Jan 2021, single dose, for COVID-19 immunisation. Medical history included patient had difficulty breathing prior to the vaccine (unspecified if ongoing). The patient's concomitant medications not reported. Onset 2021,  patient had fatigue (tiredness), dyspnea (SOB), with outcome of unknown; dyspnea (trouble breathing), with outcome of not recovered; and nausea (queasy stomach), with outcome of unknown. Additional information: Patient received the Pfizer COVID-19 vaccine Jan 2021 and looking for a copy of the vaccination card (she wanted a replacement). Patient had difficulty breathing prior to the vaccine. She had some side effects from the vaccine she received in January. Stated she had been queasy on the stomach and not sure if that was associated with the vaccine. She also had difficulty breathing after walking and becomes winded. For the last few months, she had trouble breathing. This occurs especially when she was exerting herself, such as raking leaves, walking or walking any distance like in the mall. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Upper arm got red and itchy immediately after; Upper arm got red and itchy immediately after; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 17 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 27Nov2021 12:00 (Lot number: Fh8030) at the age of 17 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known Allergies: Latex" (unspecified if ongoing); "COVID-19" (unspecified if ongoing). Concomitant medication(s) included: LEVOXYL; ADDERALL; PROZAC. The following information was reported: ERYTHEMA (non-serious), PRURITUS (non-serious) all with onset 27Nov2021 12:00, outcome "recovered" (2021) and all described as "Upper arm got red and itchy immediately after". Therapeutic measures were not taken as a result of erythema, pruritus.  Additional information: The patient had not received any other vaccine within 4 weeks prior to the vaccine, and not tested COVID post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Bone pain, Chills, Feeling abnormal, Head discomfort
Clinical narrative: chills; every bone in her body is aching; head is plugged up (head congestion); stomach is cramping really bad; eyes are puffy; She was miserable; 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 54 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 26Nov2021 02:30 (Lot number: 330308D) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing); "Thyroid issue" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 27Nov2021, outcome "unknown", described as "chills"; BONE PAIN (non-serious) with onset 27Nov2021, outcome "unknown", described as "every bone in her body is aching"; HEAD DISCOMFORT (non-serious) with onset 27Nov2021, outcome "unknown", described as "head is plugged up (head congestion)"; ABDOMINAL PAIN UPPER (non-serious) with onset 27Nov2021, outcome "unknown", described as "stomach is cramping really bad"; PERIORBITAL SWELLING (non-serious) with onset 27Nov2021, outcome "unknown", described as "eyes are puffy"; FEELING ABNORMAL (non-serious) with onset 27Nov2021, outcome "unknown", described as "She was miserable".  Additional info: Patient stated she had never been so miserable in her life. The caller's symptoms started Saturday, the day after she got the vaccine. Then on Saturday and Sunday the caller stayed in the bed all day. The caller went to work Monday and dragged through it. Yesterday the caller had a doctors appointment so she went to that. Then today the caller couldn't even get out of bed.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Periorbital swelling
Clinical narrative: chills; every bone in her body is aching; head is plugged up (head congestion); stomach is cramping really bad; eyes are puffy; She was miserable; 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 54 year-old female patient received bnt162b2 (COMIRNATY), administered in arm right, administration date 26Nov2021 02:30 (Lot number: 330308D) at the age of 54 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Mitral valve prolapse" (unspecified if ongoing); "Thyroid issue" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 27Nov2021, outcome "unknown", described as "chills"; BONE PAIN (non-serious) with onset 27Nov2021, outcome "unknown", described as "every bone in her body is aching"; HEAD DISCOMFORT (non-serious) with onset 27Nov2021, outcome "unknown", described as "head is plugged up (head congestion)"; ABDOMINAL PAIN UPPER (non-serious) with onset 27Nov2021, outcome "unknown", described as "stomach is cramping really bad"; PERIORBITAL SWELLING (non-serious) with onset 27Nov2021, outcome "unknown", described as "eyes are puffy"; FEELING ABNORMAL (non-serious) with onset 27Nov2021, outcome "unknown", described as "She was miserable".  Additional info: Patient stated she had never been so miserable in her life. The caller's symptoms started Saturday, the day after she got the vaccine. Then on Saturday and Sunday the caller stayed in the bed all day. The caller went to work Monday and dragged through it. Yesterday the caller had a doctors appointment so she went to that. Then today the caller couldn't even get out of bed.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breakthrough pain
Clinical narrative: breakthrough; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 64 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: CORTISONE. Vaccination history included: Bnt162b2 (Dose: 1), for COVID-19 Immunization. The following information was reported: BREAKTHROUGH PAIN (non-serious), outcome "unknown", described as "breakthrough".  Additional information: Caller was a patient/consumer. Pfizer covid 19 vaccine confirmed. Caller shared that she received her first two doses of the Pfizer covid 19 vaccine. Caller decided to receive the Moderna booster dose. Caller wanted to know if she was covered by her booster dose since it equals 0.25mL and the Moderna booster dose is 0.3mL? Shared that the Pfizer booster dose was the same vaccine as the Pfizer two dose primary series, referencing the PI (LAB-#, Revised: 19Nov2021). The caller was referred to Moderna; Referred to Pharmacist. Caller shared that she got a "breakthrough" case after receiving her Pfizer second vaccine dose. Caller declined to be transferred because she said her case may be a "one-off" case as she had recently received a cortisone shot in her knee close to the time of receiving her second Pfizer dose and shortly thereafter visited a "beauty salon" wear people were not masking.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Balance disorder, Dizziness, Fall, Illness
Clinical narrative: throwing up; off balance; dizzy; falling; he got really sick; feeling sick to stomach; 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 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Nov2021 (Lot number: 32030BD) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sick to his stomach" (unspecified if ongoing), notes: Stated that he has been getting sick to his stomach for the last 40 years.; "lost some weight" (unspecified if ongoing), notes: Stated that he lost some weight. Stated that he gradually lost weight before the Covid vaccine. There were no concomitant medications. The following information was reported: ILLNESS (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "he got really sick"; ABDOMINAL DISCOMFORT (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "feeling sick to stomach"; VOMITING (non-serious) with onset 05Nov2021, outcome "recovered" (Nov2021), described as "throwing up"; BALANCE DISORDER (non-serious) with onset 05Nov2021, outcome "recovered" (2021), described as "off balance"; DIZZINESS (non-serious) with onset 05Nov2021, outcome "recovered" (Nov2021), described as "dizzy"; FALL (non-serious) with onset 05Nov2021, outcome "unknown", described as "falling". Therapeutic measures were not taken as a result of illness, abdominal discomfort, vomiting, balance disorder, dizziness, fall.  Additional information: Patient was Stated he had the first dose of the pfizer covid vaccine on 03Nov. Reports 1-2 days after his first shot, he got really sick. Reports feeling sick to stomach; throwing up; dizzy ; off balance. He was scheduled for his 2nd shot on 24Nov but cancelled as he did not want to be sick for holiday. wanting to reschedule his appt/find out where he can. Stated that he cancelled it because it was the day before holiday and he did not know if he would get sick or not. Stated that some of his friends got sick off the first and second shots. Stated that they got sick to their stomach and nauseated. Declined to complete reports at this time. Stated that he lost some weight. Stated that he gradually lost weight before the Covid vaccine. Wanted to know if it would be safe to get the second shot. Patient was stated that 1-2 days after the shot that he got sick to his stomach for about two days. Recovered completely. Stated that he has been getting sick to his stomach for the last 40 years. Stated that two days after the shot that he was throwing up for about 2-3 days. Recovered completely. Stated that he was dizzy and off balance two days after the shot. Stated that every now and then that he will raise out of bed and like he was falling.   Follow-up attempts are completed. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: throwing up; off balance; dizzy; falling; he got really sick; feeling sick to stomach; 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 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Nov2021 (Lot number: 32030BD) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "sick to his stomach" (unspecified if ongoing), notes: Stated that he has been getting sick to his stomach for the last 40 years.; "lost some weight" (unspecified if ongoing), notes: Stated that he lost some weight. Stated that he gradually lost weight before the Covid vaccine. There were no concomitant medications. The following information was reported: ILLNESS (non-serious) with onset Nov2021, outcome "recovered" (2021), described as "he got really sick"; ABDOMINAL DISCOMFORT (non-serious) with onset Nov2021, outcome "recovered" (Nov2021), described as "feeling sick to stomach"; VOMITING (non-serious) with onset 05Nov2021, outcome "recovered" (Nov2021), described as "throwing up"; BALANCE DISORDER (non-serious) with onset 05Nov2021, outcome "recovered" (2021), described as "off balance"; DIZZINESS (non-serious) with onset 05Nov2021, outcome "recovered" (Nov2021), described as "dizzy"; FALL (non-serious) with onset 05Nov2021, outcome "unknown", described as "falling". Therapeutic measures were not taken as a result of illness, abdominal discomfort, vomiting, balance disorder, dizziness, fall.  Additional information: Patient was Stated he had the first dose of the pfizer covid vaccine on 03Nov. Reports 1-2 days after his first shot, he got really sick. Reports feeling sick to stomach; throwing up; dizzy ; off balance. He was scheduled for his 2nd shot on 24Nov but cancelled as he did not want to be sick for holiday. wanting to reschedule his appt/find out where he can. Stated that he cancelled it because it was the day before holiday and he did not know if he would get sick or not. Stated that some of his friends got sick off the first and second shots. Stated that they got sick to their stomach and nauseated. Declined to complete reports at this time. Stated that he lost some weight. Stated that he gradually lost weight before the Covid vaccine. Wanted to know if it would be safe to get the second shot. Patient was stated that 1-2 days after the shot that he got sick to his stomach for about two days. Recovered completely. Stated that he has been getting sick to his stomach for the last 40 years. Stated that two days after the shot that he was throwing up for about 2-3 days. Recovered completely. Stated that he was dizzy and off balance two days after the shot. Stated that every now and then that he will raise out of bed and like he was falling.   Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Inappropriate schedule of product administration, Movement disorder, Pain
Clinical narrative: first dose of the Pfizer Biontech COVID19 vaccine (purple cap) on 06Oct2021 and her second dose was administered on 15Oct2021 which is only 9 days apart; body was really achy, like she had aches and pains; was hard to move around; was a little stuffy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 31 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 15Oct2021 (Lot number: FF2588) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Lot Number: FF8839 , Anatomical Location: left arm, unknown expiry date), administration date: 06Oct2021, when the patient was 31 years old, for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 15Oct2021, outcome "unknown", described as "first dose of the Pfizer Biontech COVID19 vaccine (purple cap) on 06Oct2021 and her second dose was administered on 15Oct2021 which is only 9 days apart"; PAIN (non-serious) with onset 15Oct2021, outcome "recovered" (18Oct2021), described as "body was really achy, like she had aches and pains"; MOVEMENT DISORDER (non-serious) with onset 15Oct2021, outcome "recovered" (18Oct2021), described as "was hard to move around"; FEELING ABNORMAL (non-serious) with onset 15Oct2021, outcome "recovered" (18Oct2021), described as "was a little stuffy".  Additional information: Reporter Subtype: Pharmacist. Caller was a pharmacy technician calling for herself. Caller had her first dose of the Pfizer Biontech COVID19 vaccine (purple cap) on 06Oct2021 and her second dose was administered on 15Oct2021 which is only 9 days apart. Caller was asking for information regarding re-vaccination. She did have an adverse reaction from the 2nd dose that let her out of work for 2 days. Her body was really achy, like she had aches and pains, it was hard to move around and she was a little stuffy as well. The body aches was the major thing. It began that night of her vaccination, 15Oct2021 and it ended on 18Oct2021. No prior Vaccinations within 4 weeks.  No follow-up attempts are possible. No further information is expected.