chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Dehydration, Dizziness
Clinical narrative: real light headed; she could be dehydrated; This is a spontaneous report received from contactable consumer. The reporter is the patient.  A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the left arm, administration date 23Mar2021 15:30 (Lot number: EN6207) at the age of 59 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "asthma" (unspecified if ongoing); "diabetic" (not ongoing), notes: she was told she is no longer diabetic; "allergies" (unspecified if ongoing); "for stomach" (unspecified if ongoing). Concomitant medications included: SINGULAIR taken for hypersensitivity; NEXIUM [ESOMEPRAZOLE SODIUM] taken for gastric disorder; ASPIRIN [ACETYLSALICYLIC ACID]; VITAMIN B COMPLEX; ZINC; TURMERIC [CURCUMA LONGA]; VITAMIN D [ERGOCALCIFEROL]; SYMBICORT; SPIRIVA; B12 SHOT, start date: 19Mar2021, stop date: 19Mar2021. The following information was reported: DIZZINESS (non-serious) with onset 24Mar2021, outcome "recovering", described as "real light headed"; DEHYDRATION (non-serious) with onset 24Mar2021, outcome "unknown", described as "she could be dehydrated". The events "real light headed" and "she could be dehydrated" were evaluated at the physician office visit. Therapeutic measures were taken as a result of dizziness, dehydration.  Additional information: Additional concomitant medications included cholesterol pill, multivitamin, and probiotics. The patient stated the next day (on 24Mar2021) she was fine until she was out exercising outside her house on a walk and she felt light headed and it was scary. She stated she was still light headed and it has been bothering her for 5 days. She called her doctor and was told to drink lots of water and that she could be dehydrated and they would see her on Wednesday (not further specified) if it still persisted for blood pressure and blood work.   No follow-up attempts are possible. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Fatigue
Clinical narrative: milder fatigue; strong metal taste in mouth/tastes like nickel; This is a spontaneous report received from a contactable reporter nurse. The reporter is the patient.  A 76 year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 22Feb2021 13:30 (batch/lot number: EN6202) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "HBP" (unspecified if ongoing); "osteoporosis" (unspecified if ongoing); "pneumonia" (unspecified if ongoing); "valley fever" (unspecified if ongoing); "DOE" (unspecified if ongoing); "skin reaction to nickel in jewelry" (unspecified if ongoing), notes: long standing. Concomitant medication included: LOSARTAN; AMLODIPINE; IRON; VITAMIN D [COLECALCIFEROL]; VITAMIN B12 [CYANOCOBALAMIN]; BIOTIN. Past drug history included: Macrodantin, reactions: "allergies", "fever". Vaccination history included: Bnt162b2 (dose 1; administered in the left arm; batch/lot number EL9263), administration date: 29Jan2021, when the patient was 76 years old, for COVID-19 immunisation, reactions: "painful joints lasting 5 days", "fatigue". The following information was reported: FATIGUE (non-serious) with onset Mar2021, outcome "not recovered", described as "milder fatigue"; DYSGEUSIA (non-serious) with onset Mar2021, outcome "not recovered", described as "strong metal taste in mouth/tastes like nickel". Therapeutic measures were not taken as a result of fatigue, dysgeusia.  Additional information: The patient informed that she had a strong metal taste in mouth and the patient had been attributing to some recent dental work until today. The reporter considered "strong metal taste in mouth/tastes like nickel" not related to bnt162b2.   No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported event Fatigue cannot be ruled out. Event Metallic taste is assessed as Unrelated.,Linked Report(s) : US-PFIZER INC-2021339126 same reporter/patient/product, different dose/event
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: slightly sore arm; This is a spontaneous report received from a contactable reporter(s) (Nurse). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date Mar2021 (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: BNT162B2 (DOSE 1, SINGLE), for COVID-19 immunisation. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "slightly sore arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Headache
Clinical narrative: headache; tired with first dose; foggy; 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 received bnt162b2 (BNT162B2), administered in arm right, administration date 16Feb2021 10:30 (Batch/Lot number: unknown) at the age of 36 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: HEADACHE (non-serious) with onset 16Feb2021, outcome "recovered" (18Feb2021), described as "headache"; FATIGUE (non-serious) with onset 16Feb2021, outcome "recovered" (18Feb2021), described as "tired with first dose"; FEELING ABNORMAL (non-serious) with onset 16Feb2021, outcome "recovered" (18Feb2021), described as "foggy".  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 glucose, Blood glucose decreased, Dizziness
Clinical narrative: sugar dropped; was a little dizzy; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the parent.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (1st dose), for Covid-19 immunization. The following information was reported: BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "sugar dropped"; DIZZINESS (non-serious), outcome "unknown", described as "was a little dizzy". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The mother was asking if these are normal side effects.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: not feeling right; This is a spontaneous report received from contactable reporter (Consumer). The reporter is the patient.  A 71-year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Mar2021 (Batch/Lot number: unknown) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Peripheral Neuropathy" (unspecified if ongoing). Concomitant medication included: LYRICA taken for neuropathy peripheral. The following information was reported: FEELING ABNORMAL (non-serious) with onset 04Mar2021, outcome "recovered" (06Mar2021), described as "not feeling right".  Additional Information: After the first dose, she started not feeling right on Thursday, 04Mar2021, and she was better on Saturday (06Mar2021). It only lasted for a couple of days. The patient did not receive additional vaccines on same date of the Pfizer suspect. Adverse event did not require visit to emergency room or physician office.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021358435 Same patient and drug but different dose and events
Sex: F
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: Chronic back pain worsened; 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 female patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "chronic back pain" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious) with onset Mar2021, outcome "unknown", described as "Chronic back pain worsened".  Additional information: The patient was asking if she can take Tylenol and her second dose was scheduled on 31Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Skin disorder
Clinical narrative: patch of red purple breakout in my left shoulder and another on my breast and by day end it turned dark; 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 83 year-old patient received bnt162b2 (BNT162B2), administration date 18Feb2021 (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: SKIN DISORDER (non-serious) with onset 19Feb2021, outcome "unknown", described as "patch of red purple breakout in my left shoulder and another on my breast and by day end it turned dark". The event "patch of red purple breakout in my left shoulder and another on my breast and by day end it turned dark" was evaluated at the physician office visit. Therapeutic measures were taken as a result of skin disorder.  Additional Information: The patient reported that some hydrocortisone cream was used and an appointment was made with a dermatologist and was given 3 bottles of rx's and 2 made the patient so nauseated so it was thrown away. When the patient saw the primary doctor, he said to just use cream.  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: Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Arm tingling/tingling is going down to her hand; Arm soreness/pain and soreness in injected arm/lot of pain in the left arm; Swollen arm; This is a spontaneous report received from contactable reporter (nurse) from medical information team for a Pfizer sponsored program. The reporter is the patient. Other Case identifier: US-PFIZER INC-2021364320 (Pfizer).  A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 27Mar2021 14:30 (Lot number: 5R8734) at the age of 58 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Blood pressure high" (ongoing), notes: Diagnosed at age 34; takes Nifidene 30mg everyday; "High cholesterol" (ongoing), notes: Diagnosed at age 34; takes Simvastatin 20mg once per day by mouth; "Back pain" (unspecified if ongoing). Concomitant medications included: SIMVASTATIN taken for blood cholesterol increased (ongoing); NIFEDINE taken for blood pressure high; ALEVE taken for back pain; NAPROXEN. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Mar2021, outcome "recovering", described as "Arm soreness/pain and soreness in injected arm/lot of pain in the left arm"; PERIPHERAL SWELLING (non-serious) with onset 27Mar2021, outcome "recovering", described as "Swollen arm"; PARAESTHESIA (non-serious) with onset 02Apr2021, outcome "recovering", described as "Arm tingling/tingling is going down to her hand". Therapeutic measures were not taken as a result of pain in extremity, paraesthesia.  Additional information: She was scheduled to have the 2nd dose of the vaccine on 24Apr2021. No additional vaccines administered on same date of the Pfizer Suspect. The events did not require a visit to ER or MD office. No prior Vaccinations (within 4 weeks). No family medical history relevant to the events and no relevant tests.  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headache; 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 (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Mar2021 13:30 (Lot number: EN6207) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "PCOS" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Asa, reaction(s): "allergies", notes: Known allergies: ASA. The following information was reported: HEADACHE (non-serious) with onset Mar2021, outcome "recovered" (Mar2021), described as "Headache".  Additional information: No other vaccine in four weeks. No covid prior to vaccination. Not covid tested post vaccination. Headache 1st shot lasting 3 days.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021355973 Same reporter/patient/vaccine, different dose/event
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Illness, Nausea, Oropharyngeal pain
Clinical narrative: developing a sore throat; got very nauseous / was sick with nausea for another week; was sick with nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 68 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 07Feb2021 (Lot number: EL9267) at the age of 68 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing), notes: probably 2009 before that high blood pressure, don't know the exact; "breast cancer" (unspecified if ongoing), notes: had breast cancer but in Remission. Concomitant medication(s) included: GLIMEPIRIDE; GLIPIZIDE; AMLODIPINE BESYLATE; LISINOPRIL; LEVOXYL; SIMVASTATIN. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "recovered", described as "developing a sore throat"; NAUSEA (non-serious), outcome "unknown", described as "got very nauseous / was sick with nausea for another week"; ILLNESS (non-serious), outcome "unknown", described as "was sick with nausea". The event "developing a sore throat" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of oropharyngeal pain. Additional information: Clinical course: The patient took the first shot on 07Feb 2021, the patient developed a sore throat on second week and saw her doctor on 22Feb2021 and was given with a Zyrtec for sore throat. The patient got rid of the sore throat with antibiotics. On an unspecified date (reported as 2 days later), patient got very nauseous and was sick with nausea for another week. Ondansetron 4mg I can take 4-3 hours 1 tablet as needed was the treatment given for the event nausea. It was reported that the patient just changed her diabetic medication and she thought it was the time of the first shot she was still taking. The patient reported that she was taking "Amlokinda" but the insurance couldn't pay for it and they put her on "Fericita"; and reported that the insurance Insurance wanted her to take "Fericita" somewhere between first and second shot.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Sick; 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), administration date 25Mar2021 (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: ILLNESS (non-serious) with onset 26Mar2021, outcome "recovering", described as "Sick".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I have an abundance of energy and I feel like my inflammation has been significantly reduced.; 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 patient (no qualifiers provided) received BNT162B2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Lupus SLE" (unspecified if ongoing); "thallasemia beta minor" (unspecified if ongoing). The patient's concomitant medications were not reported.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I have an abundance of energy and I feel like my inflammation has been significantly reduced.".  Additional information: The patient has lupus SLE and thalassemia beta minor. The patient had both Pfizer COVID-19 vaccines and after each shot he/she feel great. The patient had an abundance of energy and felt like that his/her inflammation has been significantly reduced.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: Got sick; Not feeling well; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Lot number: ER2613) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Cancer" (ongoing). The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Got sick"; MALAISE (non-serious), outcome "unknown", described as "Not feeling well".  Additional information: The patient had chemo next day after the vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Dizzy; Slept all day; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 26Mar2021 (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: FATIGUE (non-serious) with onset 26Mar2021, outcome "unknown", described as "Slept all day"; DIZZINESS (non-serious) with onset 27Mar2021, outcome "unknown", described as "Dizzy".  Additional information: The patient and his wife got the shot yesterday (at the time of reporting) and then woke up, yesterday they came home and slept all day. The patient was asking if that was normal but then this morning when he got up, he was very dizzy. The patient was asking if that was normal and if it was a side effect.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: slept all day; This is a spontaneous report received from a contactable consumer.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 26Mar2021 (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: FATIGUE (non-serious) with onset 26Mar2021, outcome "unknown", described as "slept all day".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: had medicinal taste; 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 female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection) (Batch/Lot number: unknown) 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, SINGLE), for COVID-19 immunisation. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "had medicinal taste".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Malaise, Nasopharyngitis
Clinical narrative: felt like cold coming on; chills; malaise; headache same day as vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 22Mar2021 09:30 (Lot number: EP6955) at the age of 66 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Rheumatoid arthritis" (unspecified if ongoing); "COVID-19" (unspecified if ongoing); "allergies" (unspecified if ongoing). Concomitant medication(s) included: HYDROXYCHLOROQUINE. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 23Mar2021, outcome "recovered" (Mar2021), described as "felt like cold coming on"; HEADACHE (non-serious) with onset 22Mar2021, outcome "recovered" (Mar2021), described as "headache same day as vaccine"; CHILLS (non-serious) with onset 23Mar2021, outcome "recovered" (Mar2021), described as "chills"; MALAISE (non-serious) with onset 23Mar2021, outcome "recovered" (Mar2021), described as "malaise". Therapeutic measures were not taken as a result of nasopharyngitis, headache, chills, malaise.  Additional information: The patient was not pregnant at the time of vaccination. Concomitant medications also included an unspecified multivitamin. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccine. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.    No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diarrhea" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea". Therapeutic measures were taken as a result of diarrhoea. Additional information: The patient wants to know if she can resume taking antibiotics for her Diarrhea. She is taking antibiotics every two weeks but hasn't taken it yet. Patient has an appointment for the second dose of the Covid19 this Wednesday 31Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, SARS-CoV-1 test
Clinical narrative: Chills; Headache; Body pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 22Mar2021 (Lot number: EP6955) 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: CHILLS (non-serious) with onset 27Mar2021, outcome "unknown", described as "Chills"; HEADACHE (non-serious) with onset 27Mar2021, outcome "unknown", described as "Headache"; PAIN (non-serious) with onset 27Mar2021, outcome "unknown", described as "Body pain". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: ache in the arm; This is a spontaneous report received from a contactable reporter (Consumer).  A 65-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 01Feb2021 09:15 (Batch/Lot number: unknown) at the age of 65 years as dose 2, single for covid-19 immunisation. Illness at vaccination included: "Illness At Vacc." (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot No. EK9231, Administration Site: Left Arm.), administration date: 13Jan2021, for Covid-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 02Feb2021, outcome "recovered" (03Feb2021), described as "ache in the arm". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: The patient has not received any other products. When sharing her experience with the Covid 19 vaccine she reported she and her husband both had an ache in the arm after receiving their Covid 19 vaccines. She and her husband both had their vaccines in the left arms. She reported the ache started the day after the injection and only lasted about 24 hours. She reported the ache in his arm began the next day after the vaccine and also lasted about 24 hours. It was resolved the next day. She confirmed the dates of the vaccines and the lot numbers for her and her husband were the same. They both had their Covid 19 vaccines at the same place and at the same time. Her husband went with her to get the Covid 19 test. Her husband had the Covid 19 test also and his was negative also. The patient has history of previous immunization with first Covid 19 vaccine. The patient has no additional administered vaccine on the same date with COVID-19 Vaccine. The adverse event did not require emergency room nor physician office visit. The patient has no prior vaccination within 4 weeks and has no adverse events following prior vaccinations.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021349683 Same Reporter, Different Patient.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Fatigue, Headache
Clinical narrative: headache; fatigue; blood pressure has gone up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 26Mar2021 (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: BLOOD PRESSURE INCREASED (non-serious) with onset 27Mar2021, outcome "unknown", described as "blood pressure has gone up"; HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "fatigue". 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: Feeling abnormal
Clinical narrative: Said vaccine drove her completely crazy; This is a spontaneous report received from a contactable reporter (Consumer) for a sponsored program (159558). The reporter is the patient.  A 82 year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (Dose 1, Bach/Lot number: unknown), for covid-19 immunization, reaction: "drove her completely crazy". The following information was reported: FEELING ABNORMAL (non-serious), outcome "unknown", described as "Said vaccine drove her completely crazy".  Additional information: Patient had both doses of covid vaccine and had reaction both times after vaccine. She said that vaccine drove her completely crazy.   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: Balance disorder, Dizziness, Fatigue, Headache, Malaise
Clinical narrative: Super tired; Kind of dizzy, had dizzy spells ringing in my ears; There is still ringing in my ear so it makes you kind of nauseous; There is still ringing in my ear so it makes you kind of nauseous; I am off balance; Headache; I still don't feel right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: EP7534) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Unspecified allergies" (unspecified if ongoing); "Feel like there was fluid or something in my ear" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity, ear discomfort (ongoing). The following information was reported: MALAISE (non-serious) with onset 19Mar2021, outcome "unknown", described as "I still don't feel right"; FATIGUE (non-serious) with onset 20Mar2021, outcome "recovering", described as "Super tired"; DIZZINESS (non-serious) with onset 20Mar2021, outcome "not recovered", described as "Kind of dizzy, had dizzy spells ringing in my ears"; TINNITUS (non-serious), NAUSEA (non-serious) all with onset 20Mar2021, outcome "recovering" and all described as "There is still ringing in my ear so it makes you kind of nauseous"; BALANCE DISORDER (non-serious) with onset 20Mar2021, outcome "unknown", described as "I am off balance"; HEADACHE (non-serious) with onset 20Mar2021, outcome "unknown", described as "Headache". Therapeutic measures were taken as a result of headache.  Additional information: The patient went to a chiropractor hoping that will help a bit for the dizziness part and it did help a little. The patient took TYLENOL for headache.   No follow-up attempts are possible. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Tinnitus
Clinical narrative: Super tired; Kind of dizzy, had dizzy spells ringing in my ears; There is still ringing in my ear so it makes you kind of nauseous; There is still ringing in my ear so it makes you kind of nauseous; I am off balance; Headache; I still don't feel right; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 64 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Mar2021 (Lot number: EP7534) at the age of 64 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Unspecified allergies" (unspecified if ongoing); "Feel like there was fluid or something in my ear" (unspecified if ongoing). Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE] taken for hypersensitivity, ear discomfort (ongoing). The following information was reported: MALAISE (non-serious) with onset 19Mar2021, outcome "unknown", described as "I still don't feel right"; FATIGUE (non-serious) with onset 20Mar2021, outcome "recovering", described as "Super tired"; DIZZINESS (non-serious) with onset 20Mar2021, outcome "not recovered", described as "Kind of dizzy, had dizzy spells ringing in my ears"; TINNITUS (non-serious), NAUSEA (non-serious) all with onset 20Mar2021, outcome "recovering" and all described as "There is still ringing in my ear so it makes you kind of nauseous"; BALANCE DISORDER (non-serious) with onset 20Mar2021, outcome "unknown", described as "I am off balance"; HEADACHE (non-serious) with onset 20Mar2021, outcome "unknown", described as "Headache". Therapeutic measures were taken as a result of headache.  Additional information: The patient went to a chiropractor hoping that will help a bit for the dizziness part and it did help a little. The patient took TYLENOL for headache.   No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Malaise
Clinical narrative: Fatigue; Malaise; Mild headache; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A 66-year-old female patient received BNT162B2 (BNT162B2), intramuscular, administered in arm left, administration date 04Mar2021 13:45 (Lot number: EN6205) at the age of 66 years as dose 2, single for COVID-19 immunization. Relevant medical history included: "Osteoporosis", start date: 2018 (ongoing); "Benign palpitations", start date: 1985 (ongoing). Family history included: "Herpes simplex 1", start date: 16Feb2021, stop date: 24Feb2021. Concomitant medication included: METOPROLOL SUCCINATE taken for palpitations, start date: 2011 (ongoing). Vaccination history included: Prevnar 13 (DOSE 1; arm), administration date: 08Jan2021, when the patient was 66 years old, for Immunization; Bnt162b2 (DOSE 1; Lot Number: EM9809; 14:30; left arm), administration date: 11Feb2021, when the patient was 66 years old, for COVID-19 immunization, reaction: "Herpes simplex 1". The following information was reported: FATIGUE (non-serious) with onset 05Mar2021 08:00, outcome "recovered" (06Mar2021), described as "Fatigue"; MALAISE (non-serious) with onset 05Mar2021 08:00, outcome "recovered" (06Mar2021), described as "Malaise"; HEADACHE (non-serious) with onset 05Mar2021 08:00, outcome "recovered" (06Mar2021), described as "Mild headache". Therapeutic measures were not taken as a result of fatigue, malaise, headache.  Additional Information: With the patient's second vaccine, she instead had a mild headache and malaise upon waking on the day after her second dose, which resolved within a day. The events were considered non-serious. The patient provided information to the healthcare professional regarding the reported adverse events with the use of the product. The reporting healthcare professional considers that the Pfizer product had a causal effect to the adverse events.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021193300 Same patient and product; different events and dose
Sex: U
Vaccine: COVID19
Symptoms: Nodule
Clinical narrative: developed a nodule; This is a spontaneous report received from contactable reporter (other healthcare professional).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Past drug history included: Restylane defyne, notes: 6 months ago. The following information was reported: NODULE (non-serious), outcome "unknown", described as "developed a nodule".  Additional information: Reported patient had Restylane Defyne 6months ago and had a Covid-19 vaccine recently and developed a nodule. HCP was not sure which Covid-19 vaccine the patient received.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Injection site extravasation, Underdose
Clinical narrative: patient was given the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine but only got 0.1 ml of the dose, instead of the full dose.; patient was given the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine but only got 0.1 ml of the dose, instead of the full dose.; the rest of the dose ran down the patient's arm.; This is a spontaneous report received from a non-contactable reporter(s) (Pharmacist) from medical information team.  A female patient received bnt162b2 (BNT162B2), administered in arm (Batch/Lot number: unknown) as dose 1, 0.1 ml single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), UNDERDOSE (non-serious), outcome "unknown" and all described as "patient was given the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine but only got 0.1 ml of the dose, instead of the full dose."; INJECTION SITE EXTRAVASATION (non-serious), outcome "unknown", described as "the rest of the dose ran down the patient's arm.".  Additional Information: Pharmacist reported, patient was given the 1st dose of the Pfizer-BioNTech Covid-19 Vaccine but only got 0.1 ml of the dose, instead of the full dose. Reporter stated that the rest of the dose was ran down the patient's arm. She wanted to know what was the best practice to obtain the additional 0.2 ml and she also wanted to know, if they should get a brand new vial and administer the 0.2 ml or use the contents of another vial that had an excess amount of the 0.2 ml they dropped.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: ask if not feeling is the side effects from her second dose of the covid-19 vaccine which she got yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 26Mar2021 (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: BNT162B2 (dose 1), administration date: 04Mar2021, for COVID-19 immunisation. The following information was reported: HYPOAESTHESIA (non-serious) with onset Mar2021, outcome "unknown", described as "ask if not feeling is the side effects from her second dose of the covid-19 vaccine which she got yesterday".  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
Clinical narrative: needs to take pain medication after the covid-19 vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PAIN (non-serious), outcome "unknown", described as "needs to take pain medication after the covid-19 vaccine".  Additional Information: Patient had a familiar who need to take pain medication, she stated this was not related to a side-effect of the vaccine. They would like to know why immunity last longer in people who had Covid-19 than in people who only received the Pfizer-BioNTech Covid-19 vaccine. They stated that anything documents if they were going to have a booster (a third dose). She hadn't had the vaccine yet because there are many rumors. They stated that people who had covid-19 prior to the vaccine were protected up to 9 months or a year and people who received the vaccine but didn't have covid-19 prior to vaccination have a shorter protection time against Covid-19 (3 months), she also said that people who had Covid-19 and then the vaccine were getting very sick sand this were not happening with people who did not have covid-19 and received the vaccine. They said a familiar needs to take pain medication after the covid-19 vaccine however this were not related to a side effect of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: she is now experiencing light headedness; This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient.  A female patient 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: DIZZINESS (non-serious), outcome "unknown", described as "she is now experiencing light headedness".  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: experiencing pain when lifting his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 15Mar2021 (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: PAIN IN EXTREMITY (non-serious) with onset Mar2021, outcome "unknown", described as "experiencing pain when lifting his arm".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea
Clinical narrative: This is a spontaneous report received from a contactable reporter (Consumer) for a Pfizer sponsored program. The reporter is the patient. A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported.The following information was reported: RHINORRHOEA (non-serious) with onset 29Mar2021, outcome "unknown", described as "runny nose"; NASOPHARYNGITIS (non-serious) with onset 29Mar2021, outcome "unknown", described as "colds". Additional information: Caller was scheduled to have her second dose today (29Mar2021). She has no fever but she was experiencing runny nose. Her daughter had a cold last week that's why she was about to have it as well. Wanted to know if she still needed to get the second dose. She forgot the exact date for her first dose but it was in the 1st week of March. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: I was sick for three days; 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-2021349331 (Pfizer). A male patient 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: ILLNESS (non-serious), outcome "unknown", described as "I was sick for three days".  Aditional information: it was reported that the patient had to take off for three days of work because he was sick for three days. He commented what kind of vaccine makes you sick for three days.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Aphasia
Clinical narrative: one of his friends lost their speech after receiving a COVID vaccine; 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: APHASIA (non-serious), outcome "unknown", described as "one of his friends lost their speech after receiving a COVID vaccine".  Additional Information: Reporter stated he did not know which COVID vaccine they received and his friends wife was really upset about it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: feeling tired; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program. The reporter is the parent.  A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 26Mar2021 (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: FATIGUE (non-serious) with onset 26Mar2021, outcome "unknown", described as "feeling tired".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (159558). A male patient received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine, solution for injection, batch/lot# unknown), on Mar 26, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. Vaccination history included the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), for COVID-19 immunisation. The patient had lymphadenopathy/swollen lymph nodes, onset Mar 2021, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.