chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Dysphonia, Nasal congestion, Nasopharyngitis, Oropharyngeal pain
Clinical narrative: Sore throat; hoarse; congestion; low grade cold; 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 male patient received bnt162b2 (BNT162B2), administration date 10Mar2021 (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: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Sore throat"; DYSPHONIA (non-serious), outcome "unknown", described as "hoarse"; NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "low grade cold".  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-2021355774 Same reporter, drug, and event; different patient
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Joint swelling, Limb discomfort, Lymphadenopathy, Peripheral swelling, Weight
Clinical narrative: might be lymph glands in the brachial; small swelling in upper arm; she went up a bit in weight; she has felt something in her upper right arm that has been uncomfortable; swelling in elbows / swelling in the elbow (size of a 25 cent piece; 3 quarters an inch); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021344901 (Pfizer).  A 95 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 13:00 (Batch/Lot number: unknown) at the age of 95 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (ongoing), notes: diagnosed about a year ago. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for blood pressure abnormal (ongoing). Vaccination history included: Bnt162b2 (1st dose), administration date: 04Feb2021, when the patient was 95 years old, for COVID-19 immunisation. The following information was reported: JOINT SWELLING (non-serious) with onset Mar2021, outcome "recovering", described as "swelling in elbows / swelling in the elbow (size of a 25 cent piece; 3 quarters an inch)"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "might be lymph glands in the brachial"; PERIPHERAL SWELLING (non-serious), outcome "recovering", described as "small swelling in upper arm"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "she went up a bit in weight"; LIMB DISCOMFORT (non-serious), outcome "recovering", described as "she has felt something in her upper right arm that has been uncomfortable". The event "swelling in elbows / swelling in the elbow (size of a 25 cent piece; 3 quarters an inch)" 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 limb discomfort.  Additional information: The events did not result to ER visit. The patient had not received any other vaccines within 4 weeks prior vaccination. The patient reported that she was using just a little heating pad type thing because at night the discomfort in her arm would keep her awake for the first week.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 95.0
Sex: F
Vaccine: COVID19
Symptoms: Weight increased
Clinical narrative: might be lymph glands in the brachial; small swelling in upper arm; she went up a bit in weight; she has felt something in her upper right arm that has been uncomfortable; swelling in elbows / swelling in the elbow (size of a 25 cent piece; 3 quarters an inch); This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-2021344901 (Pfizer).  A 95 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Feb2021 13:00 (Batch/Lot number: unknown) at the age of 95 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (ongoing), notes: diagnosed about a year ago. Concomitant medication(s) included: HYDROCHLOROTHIAZIDE taken for blood pressure abnormal (ongoing). Vaccination history included: Bnt162b2 (1st dose), administration date: 04Feb2021, when the patient was 95 years old, for COVID-19 immunisation. The following information was reported: JOINT SWELLING (non-serious) with onset Mar2021, outcome "recovering", described as "swelling in elbows / swelling in the elbow (size of a 25 cent piece; 3 quarters an inch)"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "might be lymph glands in the brachial"; PERIPHERAL SWELLING (non-serious), outcome "recovering", described as "small swelling in upper arm"; WEIGHT INCREASED (non-serious), outcome "unknown", described as "she went up a bit in weight"; LIMB DISCOMFORT (non-serious), outcome "recovering", described as "she has felt something in her upper right arm that has been uncomfortable". The event "swelling in elbows / swelling in the elbow (size of a 25 cent piece; 3 quarters an inch)" 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 limb discomfort.  Additional information: The events did not result to ER visit. The patient had not received any other vaccines within 4 weeks prior vaccination. The patient reported that she was using just a little heating pad type thing because at night the discomfort in her arm would keep her awake for the first week.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Chills, Diarrhoea, Fatigue
Clinical narrative: pain in my armpits-mainly in the armpit of the shot; High back pain; Sore arm; Chills; Sweats; Heart palpitations; Nausea; Diarrhea; Tired; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28Mar2021 08:00 (Lot number: ER8730) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Factor V" (unspecified if ongoing); "MTHFR" (unspecified if ongoing); "Hemochromatosis" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; FARXIGA; SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LEXAPRO. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Sore arm"; CHILLS (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Sweats"; PALPITATIONS (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Heart palpitations"; NAUSEA (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Nausea"; DIARRHOEA (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Diarrhea"; FATIGUE (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Tired"; HEADACHE (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Headache"; AXILLARY PAIN (non-serious) with onset 29Mar2021 08:00, outcome "unknown", described as "pain in my armpits-mainly in the armpit of the shot"; BACK PAIN (non-serious) with onset 29Mar2021 08:00, outcome "unknown", described as "High back pain". Therapeutic measures were not taken as a result of pain in extremity, chills, hyperhidrosis, palpitations, nausea, diarrhoea, fatigue, headache, axillary pain, back pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperhidrosis, Nausea, Pain in extremity, Palpitations
Clinical narrative: pain in my armpits-mainly in the armpit of the shot; High back pain; Sore arm; Chills; Sweats; Heart palpitations; Nausea; Diarrhea; Tired; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28Mar2021 08:00 (Lot number: ER8730) at the age of 37 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Factor V" (unspecified if ongoing); "MTHFR" (unspecified if ongoing); "Hemochromatosis" (unspecified if ongoing); "Diabetes" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN; FARXIGA; SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LEXAPRO. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Sore arm"; CHILLS (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Chills"; HYPERHIDROSIS (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Sweats"; PALPITATIONS (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Heart palpitations"; NAUSEA (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Nausea"; DIARRHOEA (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Diarrhea"; FATIGUE (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Tired"; HEADACHE (non-serious) with onset 28Mar2021 10:00, outcome "recovering", described as "Headache"; AXILLARY PAIN (non-serious) with onset 29Mar2021 08:00, outcome "unknown", described as "pain in my armpits-mainly in the armpit of the shot"; BACK PAIN (non-serious) with onset 29Mar2021 08:00, outcome "unknown", described as "High back pain". Therapeutic measures were not taken as a result of pain in extremity, chills, hyperhidrosis, palpitations, nausea, diarrhoea, fatigue, headache, axillary pain, back pain.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: more tired than usual/ completely wiped out/ experiencing some side effects like fatigue and joint pain; more achy/ experiencing some side effects like fatigue and joint pain; This is a spontaneous report received from a contactable consumer for a Pfizer sponsored program (159558). The reporter is the patient.  A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in the right (upper) arm, administration date 26Mar2021 11:45 (Batch/Lot number: unknown) as dose 1, single for COVID-19 immunisation. Relevant medical history included: "Rheumatoid arthritis", start date: 1981 (ongoing), notes: normally has aches and pains daily; "lower legs swell" (ongoing), notes: not lymphedema; "poor circulation" (ongoing); "tired" (unspecified if ongoing). Family history included: "stroke" (unspecified if ongoing), notes: her mom died; "emphysema" (unspecified if ongoing), notes: her dad; "heart condition" (unspecified if ongoing), notes: her dad; "Diabetes" (unspecified if ongoing), notes: runs in her family. Concomitant medications included: ASPIRIN [ACETYLSALICYLIC ACID] taken for rheumatoid arthritis; Biologic (not further specified), taken for rheumatoid arthritis, start date: 2018, ongoing.  The following information was reported: The patient has had rheumatoid arthritis for over 30 years and has been more tired than usual and more achy. She stated that she normally has aches and pains daily due to rheumatoid arthritis. She had been doing pretty good before the vaccine shot. She got the shot on the 26Mar2021 (Lot number reported as ER8732 or CR8732). She felt okay on 27Mar2021 (Saturday). She was more tired toward the evening of 27Mar2021. The tiredness started around 16:00. The achiness was all day, but it seemed to intensify toward the evening. On 28Mar2021, she was completely wiped out. The patient mentioned that she was also experiencing some side effects like fatigue and joint pain. The events were reported as non-serious by the consumer. Therapeutic measures were not taken as a result of the events. The patient has not recovered from the events.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Limb discomfort, Rhinorrhoea
Clinical narrative: Same day/evening, slight headache on left side; runny nose; tiredness; right arm strong discomfort; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 24Mar2021 15:45 (Lot number: EP6955) at the age of 61 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, Arm left, 11:45 AM), administration date: 03Mar2021, for Covid 19 immunization. The following information was reported: HEADACHE (non-serious) with onset 24Mar2021 18:00, outcome "recovered", described as "Same day/evening, slight headache on left side"; RHINORRHOEA (non-serious) with onset 24Mar2021 18:00, outcome "recovered", described as "runny nose"; FATIGUE (non-serious) with onset 24Mar2021 18:00, outcome "recovered", described as "tiredness"; LIMB DISCOMFORT (non-serious) with onset 24Mar2021 18:00, outcome "recovered", described as "right arm strong discomfort". Therapeutic measures were not taken as a result of headache, rhinorrhoea, fatigue, limb discomfort. Additional information: The facility where the most recent COVID-19 vaccine was administered in other (as reported). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient has not been tested for COVID-19. Patient had no allergies to medications, food, or other products.  No follow-up attempts are possible. No further information is expected.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Pain in extremity
Clinical narrative: A little weak; Arm was sore; 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 77 year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in right arm, administration date 26Feb2021 (Lot number: EN6200) at the age of 77 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "vertigo" (unspecified if ongoing), notes: at least 15 to 20 years ago; "Meniere's ear" (unspecified if ongoing), notes: at least 15 to 20 years ago; "endolymphatic shunt" (unspecified if ongoing), notes: at least 20 years ago. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 27Feb2021, outcome "recovered" (02Mar2021), described as "Arm was sore"; ASTHENIA (non-serious) with onset 01Mar2021, outcome "recovered" (02Mar2021), described as "A little weak". Additional information: Vaccination time was reported as around 02:45 PM to 03:00 PM.  No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.   A 37 year-old female patient (not pregnant) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administered in arm left, administration date 31Mar2021 11:00 (Lot number: EP6955) at the age of 37 years 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; lot number=EL3247; administration time=11:00 AM; vaccine location=Left arm,), administration date: 10Mar2021, when the patient was 37 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 31Mar2021 21:00, outcome "recovering", described as "Soreness in arm"; VACCINATION SITE PAIN (non-serious) with onset 31Mar2021 21:00, outcome "recovering", described as "Soreness at injection site"; PAIN (non-serious) with onset 31Mar2021 21:00, outcome "recovering", described as "Body aches all over". Therapeutic measures were not taken as a result of pain in extremity, vaccination site pain, pain.   No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Fatigue, Nasopharyngitis, Somnolence
Clinical narrative: cold; tired; stomach discomfort; sleepy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 30Mar2021 10:00 (Batch/Lot number: unknown) at the age of 56 years as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious) with onset 31Mar2021, outcome "recovering", described as "cold"; FATIGUE (non-serious) with onset 31Mar2021, outcome "recovering", described as "tired"; ABDOMINAL DISCOMFORT (non-serious) with onset 31Mar2021, outcome "recovering", described as "stomach discomfort"; SOMNOLENCE (non-serious) with onset 31Mar2021, outcome "recovering", described as "sleepy". Therapeutic measures were not taken as a result of nasopharyngitis, fatigue, abdominal discomfort, somnolence.  Additional information: Patient did not receive any other vaccines within 4 weeks prior and other medications 2 weeks prior to the COVID-19. Patient had no medical history and known allergies. No allergies to medications, food, or other products. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. The case was non serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Osteoarthritis
Clinical narrative: Swollen lymph glands in legs causing 2"swelling in both legs/a reaction of lymphatic swelling.; Osteoarthritis lumps on my fingers; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 06Feb2021 14:30 (Lot number: EN9581) at the age of 74 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Lymphadema" (unspecified if ongoing), notes: Lymphedema, no thyroid gland; "overweight" (unspecified if ongoing), notes: overweight; "Food allergy" (unspecified if ongoing), notes: Allergies to medications, food, or other products: Yes; "allergies" (unspecified if ongoing), notes: known allergies : Yes. Concomitant medication(s) included: TIROSINT SOL. Vaccination history included: Bnt162b2 (1st dose, lot: EL3248,, Time: 2:30 PM, Arm Left.), administration date: 17Jan2021, when the patient was 74 years old, for COVID-19 Immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset 15Feb2021, outcome "not recovered", described as "Swollen lymph glands in legs causing 2"swelling in both legs/a reaction of lymphatic swelling."; OSTEOARTHRITIS (non-serious) with onset 15Feb2021, outcome "not recovered", described as "Osteoarthritis lumps on my fingers". The events "swollen lymph glands in legs causing 2"swelling in both legs/a reaction of lymphatic swelling." and "osteoarthritis lumps on my fingers" were evaluated at the physician office visit. Therapeutic measures were taken as a result of lymphadenopathy, osteoarthritis.  Additional information: The patient received treatment with lymphatic therapy and Celebrex. The patient not had covid prior vaccination. The patient was not tested for covid post vaccination. Facility where the most recent COVID-19 vaccine was administered was other. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient had allergies to medications, food, or other products. The patient stated that after taking the Covid vaccine she had a reaction of lymphatic swelling. Not had covid prior vaccination and covid tested post vaccination. Facility where the most recent COVID-19 vaccine was administered was other. List of any other medications the patient received within 2 weeks of vaccination was Tirosint sol 125. The adverse event result in any of the following the doctor or other healthcare professional office/clinic visit. Prior to vaccination, was the patient diagnosed with COVID-19 and since the vaccination, has the patient been tested for COVID-19 reported as no. Allergies to medications, food, or other products reported as yes. Reporter states after taking the Covid vaccine she had a reaction of lymphatic swelling. New AE description but same as initial event term. so, follow-up received with no new AE/SD and follow up activities were already closed and completed.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: Very painful, swollen lymph nodes in the armpit and breast on the same side that the vaccine was given; Very painful, swollen lymph nodes in the armpit and breast on the same side that the vaccine was given; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 31 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Mar2021 08:45 (Batch/Lot number: unknown) at the age of 31 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Hypertension" (unspecified if ongoing); "Hashimoto's thyroiditis" (unspecified if ongoing); "Fibromyalgia" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset Mar2021, outcome "unknown" and all described as "Very painful, swollen lymph nodes in the armpit and breast on the same side that the vaccine was given".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Vaccination site pain
Clinical narrative: Very sore arm from injection; headache; body aches; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 11:45 (Lot number: EL3247) at the age of 43 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; ALAVERT; ALEVE; MULTIVITAMIN & MINERAL. Vaccination history included: Bnt162b2 (dose number:1, administration time: 10:00AM, lot number: EL3247), administration date: 10Mar2021, when the patient was 43 years old, for Covid-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 31Mar2021 22:00, outcome "recovering", described as "Very sore arm from injection"; HEADACHE (non-serious) with onset 31Mar2021 22:00, outcome "recovering", described as "headache"; PAIN (non-serious) with onset 31Mar2021 22:00, outcome "recovering", described as "body aches"; FATIGUE (non-serious) with onset 31Mar2021 22:00, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of vaccination site pain, headache, pain, fatigue.  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. Upon Follow-up on (PRD 05Apr2021) This 43-year-old female consumer (patient) responded for Query to confirm the PRD date that: this was her own adverse event to the Pfizer Covid-19 vaccine, so she is the patient. she had her second dose of the vaccine on Wed, 31Mar. she experienced these symptoms when woke up on 01Apr2021 and thats when she reported them. If they need anything else, please let her know.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: he has been having a cold for 7 days; 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), administration date 11Mar2021 (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: NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "he has been having a cold for 7 days".  Additional information: The reporter mentioned that her husband (patient) had the first dose of the Pfizer covid vaccine on 11Mar2021 and he is scheduled to get the second dose at the time of report; however, he has been having a cold for 7 days and he is scared to get the vaccine. She wonders whether he should go and get the vaccine or not.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Vertigo
Clinical narrative: Severe vertigo with nausea; Severe vertigo with nausea; Brain fog lasting into week two after second shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 12:30 (Lot number: ER8727) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: AMLODIPINE BESILATE; LEXAPRO; ROSUVASTATIN. Vaccination history included: Bnt162b2 (dose 1, product: COVID-19 , brand: Pfizer, lot number: EN6203, lot unknown: False, administration time: 12:30 PM, vaccine location: Left arm), administration date: 02Mar2021, for Covid-19 immunization. The following information was reported: VERTIGO (non-serious), NAUSEA (non-serious) all with onset 31Mar2021 20:00, outcome "recovered with sequelae" (2021) and all described as "Severe vertigo with nausea"; FEELING ABNORMAL (non-serious) with onset 31Mar2021 20:00, outcome "recovered with sequelae" (2021), described as "Brain fog lasting into week two after second shot". Therapeutic measures were not taken as a result of vertigo, nausea, feeling abnormal.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. 8 days after her second dose she experienced severe vertigo with nausea. Extreme vertigo with nausea one week after second shot. Brain fog lasting into week two after second shot. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No allergies to medications, food, or other products.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a real sore arm; This is a spontaneous report received from a non-contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), (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), outcome "recovered", described as "a real sore arm". Therapeutic measures were taken as a result of pain in extremity. Additional Information: The patient received first Pfizer COVID-19 injection and not having any side effects except for a real sore arm. She treated the sore arm by taking Tylenol but it did not help. Eventually, the soreness in the arm went away. The consumer is scheduled to get her second injection of the Pfizer covid-19 vaccine but has not received it yet. If she gets a sore arm again, she plans to take Aleve to treat it instead of Tylenol.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: robust headache; 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 52 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 31Mar2021 15:30 (Lot number: EW0150) at the age of 52 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: Verbatim: high blood pressure, caller has had for about eight years. There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset 01Apr2021, outcome "not recovered", described as "robust headache". Therapeutic measures were not taken as a result of headache.  Additional Information: The reporter wanted to known that if the event was normal or should visit the ER. The reporter also wanted to know how long was the event supposed to last. The patient said that she has never had a severe headache. The reporter confirmed that no prior vaccination were received within 4 weeks.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Facial pain, Headache, Neck pain, Sinus pain
Clinical narrative: felt pain and pressure running up the arm into the neck and side of the face; felt pain and pressure running up the arm into the neck and side of the face; pain in her head; She had the pain in her head and sinus area; chills; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 27Mar2021 (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 Immunization. The following information was reported: NECK PAIN (non-serious), FACIAL PAIN (non-serious) all with onset 30Mar2021 02:30, outcome "recovered" and all described as "felt pain and pressure running up the arm into the neck and side of the face"; HEADACHE (non-serious) with onset 30Mar2021 02:30, outcome "recovered", described as "pain in her head"; SINUS PAIN (non-serious) with onset 30Mar2021 02:30, outcome "recovered", described as "She had the pain in her head and sinus area"; CHILLS (non-serious) with onset 30Mar2021 02:30, outcome "recovered", described as "chills". Therapeutic measures were not taken as a result of neck pain, facial pain, headache, sinus pain, chills.  Additional information: The patient received any other vaccines 4 weeks prior to the COVID vaccine was unknown. The patient did not received any medication within 2 weeks of vaccination. The patient was not diagnosed with COVID-19, prior to vaccination. Since the vaccination, patient has not been tested for COVID-19. Reported as no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: She experienced soreness on her arm after the first shot, this morning she had more soreness after the second shot; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  An 85-year-old 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 (Dose 1, single (Lot Number: Not provided)), for COVID-19 Immunization, reaction: "She experienced soreness on her arm". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "She experienced soreness on her arm after the first shot, this morning she had more soreness after the second shot".  Additional Information: The patient was asking if it was true that the Pfizer's vaccine lasts up to six months.  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-2021289238 Same patient and drug; Different  dose and events
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pruritus, Rash
Clinical narrative: Site: Itching at Injection Site-Medium, Site: Redness at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Allergic: Itch Generalized-Medium, Systemic: Allergic: Rash Generalized-Medium
Age: 8.0
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: Error: Improper Storage (temperature)-
Sex: M
Vaccine: COVID19
Symptoms: Chills, Illness, Insomnia, Nasopharyngitis
Clinical narrative: chills/shivering; cold; couldn't sleep; sick as a dog; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the parent.  A 38 year-old male 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: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN, (Lot number: not provided)), for covid-19 immunization. The following information was reported: CHILLS (non-serious), outcome "unknown", described as "chills/shivering"; NASOPHARYNGITIS (non-serious), outcome "unknown", described as "cold"; INSOMNIA (non-serious), outcome "unknown", described as "couldn't sleep"; ILLNESS (non-serious), outcome "unknown", described as "sick as a dog".  Additional information: Caller stated her 38 year-old son received his second Pfizer Covid vaccine dose and experienced  "a terrible reaction all night; chills, cold, shivering, couldn't sleep and was sick as a dog."   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Systemic: Allergic: Itch (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash (specify: facial area, extremeties)-Severe, Systemic: Allergic: Rash Generalized-Severe, Systemic: ENTIRE BODY ITCHED AND HAD HIVES-Severe, Additional Details: PATIENT CAME TO PHARMACY ABOUT 15 MINUTES AFTER INJECTION COMPLAINING OF ENTIRE BODY ITCHING.  I GAVE 50MG OF BENADRYL AND SHE SAT FOR ABOUT ANOTHER 15 MINUTES WITH NO RELIEF.  I TALKED WITH  CLINIC NURSE SHE CAME OVER AND LOOKED AT PATEINT AND DETERMINED WE SHOULD CALL AN AMBULANCE.  THEY LOOKED HER OVER IN THE STORE AND SHE WALKED OUT THE DOOR WITH THEM. DON'T KNOW IF SHE WENT WITH THEM OR NOT.  I TRIED TO CALL PATIENT TO GET UPDATE BUT NO ANSWER
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose normal, Dizziness, Fatigue, Head injury, Hypophagia
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Called 911 after event occurred. Patient was standing after getting her vaccine. a couple of seconds later she passed out, hitting her head on the floor. She had no difficulty breathing; came back conscious after passing out. On arrival, EMS checked pt BG and it was normal. Patient stated to have become nauseous and light headed after getting the vaccine. Though parent said patient came to get vaccine after school and on empty stomach (that she might be hungry).
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Loss of consciousness, Nausea, Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Dizziness / Lightheadness-Severe, Systemic: Exhaustion / Lethargy-Severe, Systemic: Fainting / Unresponsive-Severe, Additional Details: Called 911 after event occurred. Patient was standing after getting her vaccine. a couple of seconds later she passed out, hitting her head on the floor. She had no difficulty breathing; came back conscious after passing out. On arrival, EMS checked pt BG and it was normal. Patient stated to have become nauseous and light headed after getting the vaccine. Though parent said patient came to get vaccine after school and on empty stomach (that she might be hungry).
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Site: Pain at Injection Site-Severe, Site: Redness at Injection Site-Severe, Site: Swelling at Injection Site-Severe, Additional Details: Pt was counseled to seek immediate medical attention at urgent care. pt urged to call back 02/12/22 to report findings from urgent care and to assure that pt is doing better. if pt fails to call, will call pt on 02/12/22
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain, Pain of skin
Clinical narrative: body aches; when you touch his arm or chest it feels like his muscles hurt and just touching the skin hurts; fatigued; when you touch his arm or chest it feels like his muscles hurt and just touching the skin hurts; 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 male patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (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 (non-serious) with onset 2021, outcome "unknown", described as "body aches"; PAIN OF SKIN (non-serious), MYALGIA (non-serious) all with onset 2021, outcome "unknown" and all described as "when you touch his arm or chest it feels like his muscles hurt and just touching the skin hurts"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "fatigued".  Additional information: The reporter stated that he had the first dose of the vaccine yesterday and feels fatigued and has body aches. He stated that when you touch his arm or chest it feels like his muscles hurt and just touching the skin hurts. He has been aching all night. He asked if this is normal? The reporter asked how long should side effects last? How long is too long for side effects to last? also asked if he should still wear a mask after getting the vaccine? Stated he is going to work tomorrow and asked if he can he give his coworkers Covid after getting the vaccine? He stated he will still be wearing a mask and social distancing. His question was less in regard to whether he is protected but more in regards to if he could get people sick from the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Pyrexia, Vomiting
Clinical narrative: Extreme dizziness, weakness, excessive vomiting, fever, 9 hours after injection.  Could not lift myself from floor for 20 hours after the weakness/dizziness began. Booster administered by pharmacy.
Sex: F
Vaccine: COVID19
Symptoms: Fall
Clinical narrative: she had a fall; 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 VACCINE), administration date 27Mar2021 (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: FALL (non-serious) with onset Mar2021, outcome "unknown", described as "she had a fall". Additional information: The reporter wanted to know if she can take Tylenol or Ibuprofen because she had a fall. First dose was given 27Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Hyperhidrosis
Clinical narrative: Systemic: Dizziness / Lightheadness-Mild, Systemic: Flushed / Sweating-Mild
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea, Pain in extremity
Clinical narrative: Nausea; Upset stomach; Arm sore; 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 48 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Mar2021 (Lot number: ER2413) at the age of 48 years 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: NAUSEA (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Nausea"; ABDOMINAL DISCOMFORT (non-serious) with onset 30Mar2021, outcome "not recovered", described as "Upset stomach"; PAIN IN EXTREMITY (non-serious) with onset 29Mar2021, outcome "recovering", described as "Arm sore".  Additional information: Patient got the first shot of Pfizer Covid vaccine on Monday morning, 29Mar2021, caller stated she has had some side effects of nausea and her stomach is so upset, this was her fourth day dealing with this and she still has it. Satated it comes in waves, cannot stop the on and off of it, has never had this problem before.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasopharyngitis, SARS-CoV-2 test
Clinical narrative: I've had a slight cold; This is a spontaneous report received from a contactable reporter (Consumer) from medical information team. The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 12Mar2021 (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: NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "I've had a slight cold". Relevant laboratory tests and procedures are available in the appropriate section. Additional Information: She received her first vaccine dose on 12Mar2021. She has had a slight cold, no covid, she took a test this week. She reported that she is scheduled for her second dose tomorrow and asked if it is ok to go in and to get it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site erythema, Vaccination site vesicles
Clinical narrative: a clear water blister on the injection site; red around the blister / on the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administration date 31Mar2021 (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: VACCINATION SITE VESICLES (non-serious) with onset 01Apr2021, outcome "unknown", described as "a clear water blister on the injection site"; VACCINATION SITE ERYTHEMA (non-serious) with onset 01Apr2021, outcome "unknown", described as "red around the blister / on the injection site".  Additional information: Patient received the second dose of the Pfizer COVID the day before (31Mar2021) and had no problems and no side effects. She mentioned that she did not remove the band aid until this morning (01Arp2021) where it got pulled off as she was changing gowns. She then found out that she had a clear water blister on the injection site. She mentioned that it was small but noticeable and has gotten bigger since she's gotten up. It was red around the blister but it was not painful. She was asking if this was common.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.