chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: sick as a dog with a fever; sick as a dog with a fever; headache; couldn't get out of bed; The patient got an equivalent of 6 doses of very concentrated mRna vaccine.; patient received 0.3 mls of undiluted vaccine; This is a spontaneous report from a contactable pharmacist via from a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: En6199; Expiration Date: 30Jun2021) via an unspecified route of administration on 05Mar2021 as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient received 0.3 ml of undiluted vaccine. Patient receiving a full undiluted vial of the covid-19 vaccine, patient received 6 doses of the vaccine, States that one of his pharmacists did not dilute the vial, and drew a dose and gave it to a patient; so the patient received 0.3mL of undiluted vaccine. The patient got an equivalent of 6 doses of very concentrated mRna vaccine. On 06Mar2021, she was sick as a dog with a fever, headache, and she couldn't get out of bed. She was not on any other medication and confirmed she had no other vaccines 4 weeks prior to receiving the Covid vaccine. The reporter also confirmed that the dose drawn was .3mL and not the full .45ml in the undiluted vial. No Prior vaccinations. The outcome of event was recovered on unspecified date 2021  No follow up attempts are possible. No further information is expected.
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rash erythematous, Rash pruritic
Clinical narrative: Vivid red itchy rash  both legs; Vivid red itchy rash  both legs; fevers; chills; This is a spontaneous report received from a contactable consumer or other non hcp.A elderly 83 years old female patient received bnt162b2 (COMIRNATY,Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 21Feb2021 09:00,at the age of 83 years old, as Dose number unknown,single for covid-19 immunization.Medical history included atrial fibrillation and hypertension from an unknown date and unknown if ongoing.Concomitant medication(s) included atenolol,diltiazem and irbesartan taken for an unspecified indication,start and stop date were not reported.The patient experienced vivid red itchy rash both legs, fever and chills on 02Mar202118:00. Therapeutic measures were taken as a result of vivid red itchy rash both legs,fever and chills.Treatment received for adverse event was Prednisone 20mg 1 pill per day 7days.The patient was not diagnosed with covid prior vaccination and not tested for covid post vaccination.The patient reported no allergies.The patient had not received any other vaccine within 4 weeks.The outcome of the events was recovering.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Pallor, Swelling face, Throat irritation
Clinical narrative: itchy throat; facial swelling; my mouth felt flushed and strange/face became flushed; pale; This is a spontaneous report from a contactable consumer (patient) reported that: A 36-years-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in left arm, on 02Mar2021 at 09: 15 AM, as dose 1 single for COVID-19 immunization at hospital. The patient medical history included hip surgery. Concomitant medication included Cerebrex, acetaminophen, vit d, and b complex. The patient did not have any known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID prior vaccination. The patient was not tested for COVID post vaccination. On 02Mar2021 09:30 itchy throat, facial swelling, my mouth felt flushed and strange, face became flushed and pale. She explained within few minutes post vaccination she experienced an itchy throat, and 10 minutes later she had facial swelling. She added 30 minutes post-vaccination, her symptoms were resolved, and she was able to go home. She asked if her symptoms were reported as a side effect to the vaccine. She experienced throat itchiness 1 minute after administration then followed by mouth flushing. 15 minutes later, she experienced face flush, but it went away after. She wanted to know if these reactions are common and if other people experience it and how they handled it. Second dose was due on 23Mar2021. Within a couple of minutes of getting my first vaccine, my throat became itchy, and my mouth felt flushed and strange. Ten minutes later my face became flushed. 15 minutes later I became very pale and was instructed to sit and was given water, crackers, and chocolate. After 30 minutes, the symptoms went away, and I went home. The patient did not receive any treatment for the events. Outcome of the event was recovered on unspecified date.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Blood urine present, Dysuria, Insomnia
Clinical narrative: blood in her urine/bloody pee; she has difficulty in sleeping; difficulty to pee; This is a spontaneous report from a contactable consumer (patient) via Pfizer-sponsored program COVAX US Support. A 65-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 05Feb2021 as Dose 2, Single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 15Jan2021 as Dose 1, Single for COVID-19 immunization. The reporter stated that after the first dose she was fine, and no adverse events experienced. But after the second dose on an unknown date in Feb2021, she experienced on Saturday and Sunday night at 11:30 PM blood in her urine. Monday morning, she went to doctor and had a prescribed medication and took blood bladder control and antibiotic for the urinary infection 2x a day for 7 day. No bad feeling after taking the medication. She was afraid may be the medication would interfere with the vaccine. She had difficulty in sleeping, difficulty to pee and she experienced bloody pee that was when she needs to go to the clinic and to the hospital. They prescribed penicillin and other medication. She was asked if penicillin will affect the vaccine effectivity. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: tightness in her chest; This is a spontaneous report from a contactable consumer (patient). A 58-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 02Mar2021 (lot number and expiry date: unknown) at the age of 58-years-old, as dose 1, single, for Covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced tightness in her chest on 02Mar2021. This patient was administered with the first dose of Pfizer-BioNTech COVID-19 Vaccine on 02Mar2021. She remained under monitoring on site for 30 minutes following the vaccine administration. She left the site and about 15 minutes later, she had onset of tightness of chest. By the end of 02Mar2021 the event was better, by 03Mar2021 it was a lot better and by 04Mar2021 event went away. She was now concerned if this event is going to happen again with the second dose. The patient recovered from the event on 04Mar2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria
Clinical narrative: Whole body itching; Welts; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL9264, Expiration date: not reported), via an unspecified route of administration in arm left on 19Feb2021 at 14:15 (at the age of 59-year-old) as a dose 2, single for COVID-19 immunization. The patient's medical history included diabetes. The patient had no known allergies. The patient's concomitant medication in two weeks included metformin, taken for an unspecified indication. Historical vaccine included BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number: EL8982, Expiration date: not reported), via an unspecified route of administration in arm left on 29Jan2021 at 16:15 (at the age of 59-year-old) as a dose 1, single for COVID-19 immunization. It was reported that, the patient was not pregnant at time of vaccination. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 20Feb2021 at 02:30 AM, the patient experienced whole body itching for 2 weeks. Welts developed on body after scratching a lot. Took benedrayl for relief. Treatment was received for the events. The outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Myalgia, Paraesthesia, Pyrexia, Vaccination site rash
Clinical narrative: Rash on my arm.  3" long at injection site; Fever on day 2 of 101.1; muscle aches; Tingling; This is a spontaneous report from a contactable consumer (patient). A 62-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL9266) via an unspecified route of administration, administered in Arm Left on 23Feb2021 18:00 (at the age of 62 years old) as dose 2, single for COVID-19 immunisation. Medical history included eggplant allergy, penicillin allergy. The patient's concomitant medications were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3302) via an unspecified route of administration, administered in Arm Left on 05Feb2021 18:00 (at the age of 62 years old) as single for COVID-19 immunisation. Patient did not received other vaccine within four weeks of COVID vaccine. Patient did not have COVID prior to vaccination. The patient experienced as, "rash on my arm. 3" long at injection site", fever on day 2 of 101.1, muscle aches, tingling on 24Feb2021 08:00. Event reported as, Rash on patient arm. 3" long at injection site. Appeared 2 days after injection. Lasted for 3 days. Fever on day 2 of 101.1, muscle aches and tingling. No treatment were given for the adverse events. The patient underwent lab tests and procedures which included body temperature: 101.1 on 24Feb2021. Patient did not tested for COVID post vaccination. Outcome of all the events were resolved on 2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dermatitis
Clinical narrative: a slight outbreak of topical dermatitis; This is a spontaneous report from a Pfizer-sponsored program. A female reporter reported for herself.  A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number, Expiry date was not reported), dose 2 via an unspecified route of administration on 03Mar2021 as dose 2, single for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was previously received first doseBNT162B2 (PFIZER BIONTECH Covid 19 Vaccine, Solution for injection, Lot Number: unknown), via unknown route on an unknown date as dose 1, single for covid-19 immunisation. On an unspecified date 2021, the patient had slight outbreak of topical dermatitis. The patient would like to take antibiotics as she had a slight outbreak of topical dermatitis. The patient also enquired about the drug dupixent is an immunosuppressant as she consulted with her doctor. The clinical outcome of the event was unknown at the time of report.   Follow-up(5Mar2021): This is a follow-up spontaneous report from a Pfizer sponsored program. A contactable consumer reported: The patient experienced an event under suspect product bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE). Clinical information was added.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Magnetic resonance imaging, Spinal osteoarthritis
Clinical narrative: thoraco-lumbar inflammation; pain in the thoracic part of my back; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number not reported), via an unspecified route of administration on Jan2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162b2 in Dec2020 for covid-19. On an unspecified date, the patient started to experience some pain in the thoracic part of her back and the Doctor sent her an MRI showing that she have a thoraco-lumbar inflammation. Patient had never suffered from back pains before. Now patient have had to take injections and take oral medications. Patient heard that it could possibly be effects from the vaccine. Outcome of the events was unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Vaccination site pain
Clinical narrative: Pain at the injection sight; Muscle soreness; Headache; This is a spontaneous report from a contactable consumer (patient). A 31-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number: EL3247), via an unspecified route of administration in left arm on 03Mar2021 15:00 (at the age of 31-years-old) as dose 1, single for COVID-19 immunization. The patient's medical history was not reported. Concomitant medication included sertraline. Prior to vaccination, the patient was not diagnosed with COVID-19, did not receive any vaccines within four weeks and was not pregnant. Patient does not have any known allergies. The patient experienced pain at the injection sight, muscle soreness and headache on 03Mar2021 15:30. Since the vaccination, patient has not been tested for COVID-19. No treatment was received for the event. Outcome of events was resolved on an unspecified date.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal discomfort, Renal pain, Swollen tongue
Clinical narrative: Within minutes, my throat started to close; tongue swell.; There was a pain that traveled from my rt kidney area to the left; This is a spontaneous report from a contactable consumer or other non hcp (patient reported for herself). A 52-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration, administered in arm right on 05Mar2021 at 14:00 (02:00 PM) (at the age of 52-year-old) as dose 1, single for COVID-19 immunization. Medical history included guillain-barre syndrome, known allergies: yes, both from an unknown date and unknown if ongoing. The patient received unspecified concomitant medications. The patient did not receive any other vaccine in four weeks. Patient was not diagnosed with COVID prior vaccination. Patient had not been COVID tested post vaccination. On 05Mar2021 at 14:00 (02:00 PM), the patient experienced within minutes, my throat started to close, tongue swell, there was a pain that traveled from my rt kidney area to the left. Adverse event: Within minutes, my throat started to close and tongue swell. There was a pain that traveled from my right kidney area to the left. Swelling decreased by half within 30 minutes and now (2 hours later) I feel nearly back to normal. The patient did not receive treatment for the events. Outcome of all the events was recovering.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Fatigue, Myalgia
Clinical narrative: cough; feeling tired; chills; muscle pain; fatigue; This is a spontaneous report from a Pfizer sponsored program. This is a spontaneous report from a contactable consumer or other non hcp. A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported and expiry date: unknown), dose 2 via an unspecified route of administration on 25Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced chills, muscle pain and fatigue on 26Feb2021, cough and feeling tired on an unspecified date. Therapeutic measures were taken as a result of muscle pain (She added that she took 2 pills of painkillers). Outcome of all the events was unknown except muscle pain which was recovering.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site erythema, Vaccination site inflammation, Vaccination site pain, Vaccination site pruritus
Clinical narrative: inflammation; redness; bruising; itching; warm and it hurts to the touch; warm and it hurts to the touch; This is a spontaneous report from a contactable consumer (patient). A 29 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route, administered in Left Arm on 03Mar2021 at 16:45 (29-year-old at vaccination) as Dose 1, single for Covid-19 immunization. Facility type vaccination was reported as Pharmacy. The patient had not received any other vaccine with in four weeks prior vaccination. The patient was non-pregnant at time of vaccination. The patient's medical history included Herniated discs, POCS (Polycystic ovaries). No allergies. The patient's concomitant medication(s) included JUNEL FE in two weeks of vaccination. The patient was not diagnosed for Covid prior vaccination. The patient was not tested for Covid post vaccination. On 04Mar2021 at 07:00 the patient at site of the injection had developed inflammation, redness, bruising, itching. It was warm and it hurts to the touch. No treatment received for resulted events. The outcome of the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: inflammation; redness; bruising; itching; warm and it hurts to the touch; warm and it hurts to the touch; This is a spontaneous report from a contactable consumer (patient). A 29 years old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route, administered in Left Arm on 03Mar2021 at 16:45 (29-year-old at vaccination) as Dose 1, single for Covid-19 immunization. Facility type vaccination was reported as Pharmacy. The patient had not received any other vaccine with in four weeks prior vaccination. The patient was non-pregnant at time of vaccination. The patient's medical history included Herniated discs, POCS (Polycystic ovaries). No allergies. The patient's concomitant medication(s) included JUNEL FE in two weeks of vaccination. The patient was not diagnosed for Covid prior vaccination. The patient was not tested for Covid post vaccination. On 04Mar2021 at 07:00 the patient at site of the injection had developed inflammation, redness, bruising, itching. It was warm and it hurts to the touch. No treatment received for resulted events. The outcome of the events was not recovered.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: I have a splotchy rash on my stomach and sides and back; This is a spontaneous report from a contactable consumer (patient). A 19-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: not reported), dose 1 via an unspecified route of administration, administered in Arm Left on 27Feb2021 at 10:00 (at the age of 19-years-old) as a DOSE 1, SINGLE for covid-19 immunisation. The patient medical history was not reported. Concomitant medication received in two weeks included finasteride (FINASTERIDE) taken for an unspecified indication, start and stop date were not reported. The patient previously took D-tap vaccine and experienced drug hypersensitivity. The patient did not receive any other vaccine in four weeks. The patient did not have COVID prior vaccination and was not tested for covid post vaccination. The patient reported that, I have a splotchy rash on my stomach and sides and back on 28Feb2021 at 11:00. He said, it has been here for 5 days and started a day after I got the vaccine. The patient did not receive any treatment for the event. Event resulted in the Doctor or other healthcare professional office/clinic visit. Outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Fatigue, Feeling cold
Clinical narrative: terrible chills; joint pain; headache; muscle pain; feeling achy; tiredness; diarrhea; freezing; feeling unwell; shaking; she took two Tylenol to help her sleep and at exactly 2:00AM; This is a spontaneous report from a contactable consumer (Patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 02Mar2021 as single dose for covid-19 immunisation. Medical history included covid-19 (very mild). The patient's concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced terrible chills joint pain, headache, muscle pain, feeling achy, tiredness, diarrhea, freezing, feeling unwell, she took two Tylenol to help her sleep and at exactly 2:00AM and shaking. Patient stated, starting yesterday and last night, she started feeling unwell with terrible chills, joint pain, headache, and muscle pain. She states that she has been getting the chills and feeling achy with tiredness. Also reported having diarrhea. She stated that she took two Tylenol to help her sleep and at exactly 2:00AM she woke up shaking and thought she was having an attack of some kind. She reported that she could not get warm and was freezing. She said she was never had a reaction like this and felt like a zombie. She also reported that she had a case of COVID-19 previously in November, describing it was a very mild case. She wanted to know if, because of these symptoms, should she not get her second dose. Therapeutic measure were taken to help her sleep. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Insomnia, Malaise, Myalgia, Pain
Clinical narrative: terrible chills; joint pain; headache; muscle pain; feeling achy; tiredness; diarrhea; freezing; feeling unwell; shaking; she took two Tylenol to help her sleep and at exactly 2:00AM; This is a spontaneous report from a contactable consumer (Patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 02Mar2021 as single dose for covid-19 immunisation. Medical history included covid-19 (very mild). The patient's concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced terrible chills joint pain, headache, muscle pain, feeling achy, tiredness, diarrhea, freezing, feeling unwell, she took two Tylenol to help her sleep and at exactly 2:00AM and shaking. Patient stated, starting yesterday and last night, she started feeling unwell with terrible chills, joint pain, headache, and muscle pain. She states that she has been getting the chills and feeling achy with tiredness. Also reported having diarrhea. She stated that she took two Tylenol to help her sleep and at exactly 2:00AM she woke up shaking and thought she was having an attack of some kind. She reported that she could not get warm and was freezing. She said she was never had a reaction like this and felt like a zombie. She also reported that she had a case of COVID-19 previously in November, describing it was a very mild case. She wanted to know if, because of these symptoms, should she not get her second dose. Therapeutic measure were taken to help her sleep. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: terrible chills; joint pain; headache; muscle pain; feeling achy; tiredness; diarrhea; freezing; feeling unwell; shaking; she took two Tylenol to help her sleep and at exactly 2:00AM; This is a spontaneous report from a contactable consumer (Patient). A 78-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), Solution for injection, via an unspecified route of administration on 02Mar2021 as single dose for covid-19 immunisation. Medical history included covid-19 (very mild). The patient's concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced terrible chills joint pain, headache, muscle pain, feeling achy, tiredness, diarrhea, freezing, feeling unwell, she took two Tylenol to help her sleep and at exactly 2:00AM and shaking. Patient stated, starting yesterday and last night, she started feeling unwell with terrible chills, joint pain, headache, and muscle pain. She states that she has been getting the chills and feeling achy with tiredness. Also reported having diarrhea. She stated that she took two Tylenol to help her sleep and at exactly 2:00AM she woke up shaking and thought she was having an attack of some kind. She reported that she could not get warm and was freezing. She said she was never had a reaction like this and felt like a zombie. She also reported that she had a case of COVID-19 previously in November, describing it was a very mild case. She wanted to know if, because of these symptoms, should she not get her second dose. Therapeutic measure were taken to help her sleep. The outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash on top of both hands, extending to a couple fingers.; Itchy rash; This is a spontaneous report from a contactable Consumer. This 47-Year-old Female Consumer (patient) reported. A 47-year-old non-pregnant female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: EL9263), dose 1 via an unspecified route of administration, administered in Arm Left on 04Feb2021 16:45 (at the age of 47-years-old) as a single dose for covid-19 immunization. Medical history included none. Concomitant medication(s) in two weeks included zinc; elderberry [sambucus nigra] (ELDERBERRY [SAMBUCUS NIGRA]); curcuma longa (TURMERIC [CURCUMA LONGA]); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]). The patient did not have any allergies. The patient had no other vaccine within four weeks. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 06Feb2021, the patient experienced rash on top of both hands, extending to a couple fingers. After 1st dose, about 2 days after the vaccine, the rash showed up on top of both hands. it's raised bumps, some larger, and all itchy. It lasted about a week. The patient did not receive any treatment. Outcome of the event was not recovered, at the time of this report. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling cold, Headache, Illness, Nausea
Clinical narrative: sick with chills; sick with chills; nausea; headache; aching all over; fever; inside out chills/feels like she is about to freeze/freezing; hurting all over; This is a spontaneous report from a contactable consumer (patient).   A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 04MAR2021 12:30 as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. It reported that the patient take Tylenol to help with the symptoms that she was experiencing after her second dose of the Pfizer BioNTech COVID-19 vaccine. Caller reported that after taking second dose yesterday around 12:30 the patient was sick with chills, nausea, headache and aching all over and about an hour ago started running a fever. The patient described that inside out chills where she did not get warm and feels like she was about to freeze. Also describes that hurting all over and that feels like her arm was going to fall off. The caller reports that the patient had no trouble after the first dose of the vaccine but they state that she had trouble with the shingles vaccine in the past where it caused her to be in bed for 3 days (details unspecified). The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: sick with chills; sick with chills; nausea; headache; aching all over; fever; inside out chills/feels like she is about to freeze/freezing; hurting all over; This is a spontaneous report from a contactable consumer (patient).   A 70-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: not reported), via an unspecified route of administration on 04MAR2021 12:30 as dose 2, single for covid-19 immunization. The patient medical history was not reported. The patient concomitant medications were not reported. It reported that the patient take Tylenol to help with the symptoms that she was experiencing after her second dose of the Pfizer BioNTech COVID-19 vaccine. Caller reported that after taking second dose yesterday around 12:30 the patient was sick with chills, nausea, headache and aching all over and about an hour ago started running a fever. The patient described that inside out chills where she did not get warm and feels like she was about to freeze. Also describes that hurting all over and that feels like her arm was going to fall off. The caller reports that the patient had no trouble after the first dose of the vaccine but they state that she had trouble with the shingles vaccine in the past where it caused her to be in bed for 3 days (details unspecified). The outcome of the events were unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Breast pain, Breast tenderness, Condition aggravated
Clinical narrative: experienced tinnitus, hip pain, tenderness under her breast; experienced tinnitus, hip pain, tenderness under her breast; experienced tinnitus, hip pain, tenderness under her breast; Tinnitus has been louder since the vaccine/It is her left hip into the leg and a little in the butt area. It got progressively worse then it stayed the same.; She thinks they said it could be lymph nodes.; burning or tenderness in the arm pit area and in the breast on left side; pain in the hip that his radiating to the back; overall tiredness; This is a spontaneous report from a contactable consumer (Patient). A 55-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Expiry date: 30Jun2021), via an unspecified route of administration (at the age of 55-years), administered in left arm on 18Feb2021 as dose 1, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient asked whether she could move her scheduled second dose of the bnt162b2 vaccine to a later date, what vitamins she could take after getting the second dose of the vaccine that won't interfere with the vaccine's effectivity, whether she could take TYLENOL after getting the bnt162b2 vaccine. Patient was wondering how current the information is, she supposed to get the shot next Thursday. If she wanted to move the date out five days because she has a personal commitment and doesn't want to be sick the day after. Some people say to hydrate before the vaccine. Are there any tips for the day before to prepare the body to not have such a reaction after the vaccine? No other additional vaccines administered on same date of the bnt162b2 vaccination. No prior vaccination within 4 weeks. The patient did not experience adverse events prior vaccination. On unspecified date, patient experienced, patient has tinnitus, but it has been an increase in volume. It is usually a much milder form. Tinnitus has been louder since the vaccine. Pain in the hip that his radiating to the back. Burning or tenderness in the arm pit area and in the breast on left side. It feels like a hot pinch in there sometimes. Patient thinks it could be lymph nodes. It has been two weeks; she has over all tiredness. Patient started to experience the side effects within a day or so. It was her left hip into the leg and a little in the butt area. It got progressively worse than it stayed the same. At the time of reporting, it may have gotten a little better. There were a couple of days it has been really terrible. She has been trying to rest it more. She has been a little achy, but then to get out of chair the weight hurts. She feels sore when she puts pressure on it. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Lymphadenopathy, Tinnitus
Clinical narrative: experienced tinnitus, hip pain, tenderness under her breast; experienced tinnitus, hip pain, tenderness under her breast; experienced tinnitus, hip pain, tenderness under her breast; Tinnitus has been louder since the vaccine/It is her left hip into the leg and a little in the butt area. It got progressively worse then it stayed the same.; She thinks they said it could be lymph nodes.; burning or tenderness in the arm pit area and in the breast on left side; pain in the hip that his radiating to the back; overall tiredness; This is a spontaneous report from a contactable consumer (Patient). A 55-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EN6201, Expiry date: 30Jun2021), via an unspecified route of administration (at the age of 55-years), administered in left arm on 18Feb2021 as dose 1, 0.3 ml single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Patient asked whether she could move her scheduled second dose of the bnt162b2 vaccine to a later date, what vitamins she could take after getting the second dose of the vaccine that won't interfere with the vaccine's effectivity, whether she could take TYLENOL after getting the bnt162b2 vaccine. Patient was wondering how current the information is, she supposed to get the shot next Thursday. If she wanted to move the date out five days because she has a personal commitment and doesn't want to be sick the day after. Some people say to hydrate before the vaccine. Are there any tips for the day before to prepare the body to not have such a reaction after the vaccine? No other additional vaccines administered on same date of the bnt162b2 vaccination. No prior vaccination within 4 weeks. The patient did not experience adverse events prior vaccination. On unspecified date, patient experienced, patient has tinnitus, but it has been an increase in volume. It is usually a much milder form. Tinnitus has been louder since the vaccine. Pain in the hip that his radiating to the back. Burning or tenderness in the arm pit area and in the breast on left side. It feels like a hot pinch in there sometimes. Patient thinks it could be lymph nodes. It has been two weeks; she has over all tiredness. Patient started to experience the side effects within a day or so. It was her left hip into the leg and a little in the butt area. It got progressively worse than it stayed the same. At the time of reporting, it may have gotten a little better. There were a couple of days it has been really terrible. She has been trying to rest it more. She has been a little achy, but then to get out of chair the weight hurts. She feels sore when she puts pressure on it. The outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Cough, Productive cough, Throat irritation
Clinical narrative: experienced cough; phlegm; chest was squeezed; throat irritation; This is a spontaneous report from a contactable consumer (patient). A 66-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 05Mar2021 as dose 1, single for covid-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that, a 66-year-old patient received her first dose of COVID-19 vaccine from Pfizer-BioNTech today, a couple of hours ago (between 10:15 am and 12:00 pm local time). Patient have experienced cough, she have phlegm, she feel as if her chest was squeezed, throat irritation, the patient was constantly coughing and was hard for her to talk, after this call she was going to call her doctor. The outcome of the events was unknown.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Ear swelling, Eye swelling, Peripheral swelling, Pharyngeal swelling, Pruritus
Clinical narrative: swollen itchy toes; facial swelling on right eye; facial swelling on ear, ear canal; facial swelling on cheek; facial swelling on throat; swollen itchy toes; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6203, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 04Mar2021 15:45 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization, at workplace clinic. The patient medical history included Post traumatic knee arthritis, Ear tubes as a child, surgery for cholesteatoma removal, hospitalization for mononucleosis, seasonal allergies, erythema multiforme, mild psoriasis, anxiety, and tubal ligation. The patient had known allergies of penicillin and soy. The patient previously took ibuprofen and had allergy. Concomitant medications included venlafaxine HCL (VENLAFAXINE HCL) and fexofenadine HCL (FEXOFENADINE HCL). The patient received no other vaccination in four weeks. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. On 04Mar2021 21:00, the patient experienced swollen itchy toes, facial swelling on right eye, facial swelling on ear, ear canal, facial swelling on cheek, and facial swelling on throat (facial swelling on right eye, ear, ear canal, cheek and throat). The patient received no treatment for the events. The outcome of the events was reported as resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: swollen itchy toes; facial swelling on right eye; facial swelling on ear, ear canal; facial swelling on cheek; facial swelling on throat; swollen itchy toes; This is a spontaneous report from a contactable consumer (patient). A 34-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EN6203, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 04Mar2021 15:45 (at the age of 34-year-old) as dose 1, single for COVID-19 immunization, at workplace clinic. The patient medical history included Post traumatic knee arthritis, Ear tubes as a child, surgery for cholesteatoma removal, hospitalization for mononucleosis, seasonal allergies, erythema multiforme, mild psoriasis, anxiety, and tubal ligation. The patient had known allergies of penicillin and soy. The patient previously took ibuprofen and had allergy. Concomitant medications included venlafaxine HCL (VENLAFAXINE HCL) and fexofenadine HCL (FEXOFENADINE HCL). The patient received no other vaccination in four weeks. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. On 04Mar2021 21:00, the patient experienced swollen itchy toes, facial swelling on right eye, facial swelling on ear, ear canal, facial swelling on cheek, and facial swelling on throat (facial swelling on right eye, ear, ear canal, cheek and throat). The patient received no treatment for the events. The outcome of the events was reported as resolving.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Fatigue, Myalgia
Clinical narrative: Fatigue; tiredness; muscle pain; chills; joint pain; This is a spontaneous report received from a contactable consumer or other non HCP. A 66-years-old female patient received 1st dose of  bnt162b2 (COMIRNATY, Batch/Lot number was not reported),via an unspecified route of administration, administered in Arm Left on 28Feb2021 11:00,at the age of 66 years old, as Dose 1,single for covid-19 immunization.Medical history included renal disorder from an unknown date and unknown if ongoing other Kidney disease stage III.The patient previously took codeine,morphine and experienced drug hypersensitivity.The patient experienced fatigue, tiredness, muscle pain, chills and joint pain on 28Feb2021 12:00.The outcome of the events was recovered.The patient had not received any vaccine within 4 weeks.The patient was not diagnosed with covid prior vaccination and not tested for covid post vaccination.The patient didn't receive any treatment for the event.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pyrexia, Vaccination site pain
Clinical narrative: Soreness at injection site; fever; chills; Soreness at injection site, fever, chills, hopfatigue and weakness; weakness; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 68-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 03Mar2021 12:00 (at the age of 68 years) (Batch/Lot Number: EM9809) as DOSE 1, SINGLE for covid-19 immunisation at Pharmacy. The patient was not pregnant at the time of vaccination. Medical history included Possible Parkinson's Disease in process of being determined from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient had known allergies to brand triple antibiotic ointment. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. 04Mar2021, the patient experienced Soreness at injection site, fever, chills, fatigue, and weakness. The patient did not receive any treatment for the events. The clinical outcome of the events was recovering at the time of vaccination. No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye pruritus, Pruritus, Urticaria
Clinical narrative: itching all over face, eyes, ears, hair; itching all over face, eyes; itching all over face, eyes, ears, hair; hives all over bidy; Lightheaded; This is a spontaneous report from a contactable consumer. A 47-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for Injection, Batch/Lot number: Unknown) via an unspecified route of administration, administered in Arm Left on 05Mar2021 13:15 as DOSE 1, SINGLE (at the age of 47-year-old) for covid-19 immunisation. Medical history included hypersensitivity. Concomitant medications included metoprolol; buprenorphine hydrochloride (BELBUCA); baclofen; omeprazole; cefixime (FLEXERIL [CEFIXIME]). The patient previously took codeine, morphine, amoxicillin, lexapro. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 05Mar2021 at 13:45, patient experienced lightheaded; itching all over face, eyes, ears, hair; hives all over body. Therapeutic measures were taken as a result of events. Patient received the treatment of 2 Benadryl, 1 chewable antacid. The outcome of the events was recovered with lasting effects on an unspecified date.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: rash on trunk; This is a spontaneous report from a contactable consumer or other non hcp.  A 57-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 07:30 (Batch/Lot Number: EN6202) as DOSE 2, SINGLE for covid-19 immunisation.  Medical history included thyroid disorder from an unknown date and unknown if ongoing. Concomitant medication(s) included levothyroxine (LEVOTHYROXINE) taken for an unspecified indication, start and stop date were not reported.  The patient previously took bnt162b2 for covid-19 immunisation, ibuprofen. Historical Vaccine BNT162B2 on 10Feb2021 COVID-19 immunisation. on 05Mar2021 the patient experienced rash on trunk. Covid prior vaccination was no covid tested post vaccination was no. Outcome of the event was not recovered.   No follow-up attempts are needed. No further information is expected.