chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Joint pain; Swollen lymph nodes; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration, administered in left arm on 06Feb2021 04:45 PM (age at vaccination was 31 years) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medication included fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6); Multi Vitamin taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 07Feb2021, 01:00 AM 12 hours after the vaccination the patient experienced Injection site pain, Tiredness, Headache, Muscle pain, Chills, Joint pain, and Swollen lymph nodes. No treatment was received for the event. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Joint pain; Swollen lymph nodes; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration, administered in left arm on 06Feb2021 04:45 PM (age at vaccination was 31 years) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medication included fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6); Multi Vitamin taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 07Feb2021, 01:00 AM 12 hours after the vaccination the patient experienced Injection site pain, Tiredness, Headache, Muscle pain, Chills, Joint pain, and Swollen lymph nodes. No treatment was received for the event. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Injection site pain; Tiredness; Headache; Muscle pain; Joint pain; Swollen lymph nodes; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 31-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EL9264), via an unspecified route of administration, administered in left arm on 06Feb2021 04:45 PM (age at vaccination was 31 years) as 2nd dose, single for COVID-19 immunization. The patient medical history was not reported. The patient concomitant medication included fish oil, oenothera biennis oil, tocopheryl acetate (OMEGA 3 & 6); Multi Vitamin taken for an unspecified indication, start and stop date were not reported. The patient had no known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not test COVID-19 positive prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 07Feb2021, 01:00 AM 12 hours after the vaccination the patient experienced Injection site pain, Tiredness, Headache, Muscle pain, Chills, Joint pain, and Swollen lymph nodes. No treatment was received for the event. The outcome of the events was recovered on an unspecified date in 2021.  Follow-up attempts completed. No further information expected
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Fatigue, Headache, Lymphadenopathy, Myalgia
Clinical narrative: Pain on my arm; This is a spontaneous report from a contactable consumer. A 31-year-old female (pregnant at time of vaccination: no) consumer received Bnt162b2 (BNT162B2; Formulation: Solution for injection, Lot number: L3247) via unknown route of administration from 15Jan2021 at unknown 1st single dose (01:00 PM) on left arm for unknown indication, and Bnt162b2 (BNT162B2; Formulation: Solution for injection, Lot number: EL9264) via unknown route of administration from 06Feb2021 at unknown 2nd single dose (04:45 PM) on left arm for unknown indication. Patient's history medical was reported as none. Other medications in two weeks includes multivitamin, and Omega 3. It was reported that I only had a bit of pain on my arm during the first dose. After the second dose, I started feeling side effects after 12hrs. My side effects were injection site pain, tiredness, headache, muscle pain, chills, joint pain, and swollen lymph nodes. Adverse Event start date was 07Feb2021, and adverse event start time was 01:00 AM. No treatment received for AE. No allergies reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient not diagnosed with COVID-19. Patient weather tested positive for COVID-19 since having the vaccine is unknown. The outcome of event was "recovered".  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vaccination site pain
Clinical narrative: Pain on my arm; This is a spontaneous report from a contactable consumer. A 31-year-old female (pregnant at time of vaccination: no) consumer received Bnt162b2 (BNT162B2; Formulation: Solution for injection, Lot number: L3247) via unknown route of administration from 15Jan2021 at unknown 1st single dose (01:00 PM) on left arm for unknown indication, and Bnt162b2 (BNT162B2; Formulation: Solution for injection, Lot number: EL9264) via unknown route of administration from 06Feb2021 at unknown 2nd single dose (04:45 PM) on left arm for unknown indication. Patient's history medical was reported as none. Other medications in two weeks includes multivitamin, and Omega 3. It was reported that I only had a bit of pain on my arm during the first dose. After the second dose, I started feeling side effects after 12hrs. My side effects were injection site pain, tiredness, headache, muscle pain, chills, joint pain, and swollen lymph nodes. Adverse Event start date was 07Feb2021, and adverse event start time was 01:00 AM. No treatment received for AE. No allergies reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient not diagnosed with COVID-19. Patient weather tested positive for COVID-19 since having the vaccine is unknown. The outcome of event was "recovered".  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Pain on my arm; This is a spontaneous report from a contactable consumer. A 31-year-old female (pregnant at time of vaccination: no) consumer received Bnt162b2 (BNT162B2; Formulation: Solution for injection, Lot number: L3247) via unknown route of administration from 15Jan2021 at unknown 1st single dose (01:00 PM) on left arm for unknown indication, and Bnt162b2 (BNT162B2; Formulation: Solution for injection, Lot number: EL9264) via unknown route of administration from 06Feb2021 at unknown 2nd single dose (04:45 PM) on left arm for unknown indication. Patient's history medical was reported as none. Other medications in two weeks includes multivitamin, and Omega 3. It was reported that I only had a bit of pain on my arm during the first dose. After the second dose, I started feeling side effects after 12hrs. My side effects were injection site pain, tiredness, headache, muscle pain, chills, joint pain, and swollen lymph nodes. Adverse Event start date was 07Feb2021, and adverse event start time was 01:00 AM. No treatment received for AE. No allergies reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient not diagnosed with COVID-19. Patient weather tested positive for COVID-19 since having the vaccine is unknown. The outcome of event was "recovered".  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: Neck swelling; This is a spontaneous report from a contactable nurse. A 30-year-old female received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: EK4176 and Expire Date: unknown) via unspecified route of administration on an unspecified date in Jan2021 (age at the time of vaccination: 30) as dose number unknown, single for Covid-19 immunisation. The patient was not pregnant at the time of vaccination. Facility type vaccine was Hospital. Patient's medical history was not reported. She had no known allergies. Concomitant medications included Lexapro for unknown indication, taken in two weeks. No other vaccine was administered in four weeks. Prior to and since vaccination, patient was not tested positive for Covid-19. After vaccination, the patient experienced neck swelling on 06Feb2021. The outcome of event was recovering without treatment.   Follow-up (14May2021): Follow-up attempts completed. No further information expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Oropharyngeal pain, Pain
Clinical narrative: chills; aches; sore throat with a fever of 99.9; sore throat with a fever of 99.9; As well as a headache; This is a spontaneous report from a contactable consumer. A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 07Feb2021 at 10:45 as single dose for COVID-19 immunization. Patient had no medical history or known allergies. Other medications (concomitant) in two weeks included buprenorphine hydrochloride, naloxone hydrochloride (Suboxone) taken for unspecified indication. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 17Jan2021 at 10:45 as single dose for COVID-19 immunization. On 08Feb2021 at 06:30, when patient woke up the day after his vaccination, he experienced chills, and aches. Also, a sore throat with a fever of 99.9 as well as a headache. Patient did not feel like it would get better very soon. It was unknown if the patient received any treatment in response to the events. Outcome of the events were not recovered.  Follow-up attempts completed. No further information expected.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: chills; aches; sore throat with a fever of 99.9; sore throat with a fever of 99.9; As well as a headache; This is a spontaneous report from a contactable consumer. A 29-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration in left arm on 07Feb2021 at 10:45 as single dose for COVID-19 immunization. Patient had no medical history or known allergies. Other medications (concomitant) in two weeks included buprenorphine hydrochloride, naloxone hydrochloride (Suboxone) taken for unspecified indication. Patient did not receive any other vaccine in four weeks. Patient did not have COVID prior vaccination and was not tested for COVID post vaccination. Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 17Jan2021 at 10:45 as single dose for COVID-19 immunization. On 08Feb2021 at 06:30, when patient woke up the day after his vaccination, he experienced chills, and aches. Also, a sore throat with a fever of 99.9 as well as a headache. Patient did not feel like it would get better very soon. It was unknown if the patient received any treatment in response to the events. Outcome of the events were not recovered.  Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph node under right arm; This is a spontaneous report from a contactable Other HCP (patient). A 47-years-old non-pregnant female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL9264), via an intramuscular route on 04Feb2021 at 16:00 (at the age of 47-years) as dose 2, single in the right arm for covid-19 immunisation. The patient medical history included RA, GERD. The patient had no known allergies. The patient concomitant medications included cyanocobalamin (B 12), calcium carbonate, colecalciferol (CALCIUM D3), celecoxib (CELEBREX), duloxetine hydrochloride (CYMBALTA), folic acid, methotrexate, montelukast sodium (SINGULAIR), multivitamin (not coded) from unknown dates and unknown if ongoing. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EL1285), via an intramuscular route on 14Jan2021 at 16:00 as dose 1, single in the left arm for covid-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. 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 05Feb2021 at 18:30, the patient experienced swollen lymph node under right arm. The patient did not received treatment for event. The outcome of the event was not recovered.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Pain, Pain in extremity
Clinical narrative: I felt severe back pain that moved from my back to my thigh and back again for 1 week on my left side of my body; I felt severe back pain that moved from my back to my thigh and back again for 1 week on my left side of my body; I felt severe back pain that moved from my back to my thigh and back again for 1 week on my left side of my body; This is a spontaneous report from a contactable consumer (reporting on herself). A 61-years-old Non-pregnant female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; formulation: Solution for injection, Lot number and expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 26Jan2021 14:30 as dose 1 single for COVID-19 immunization. The patient medical history was not reported. Concomitant medication(s) included apixaban (ELIQUIS) taken for an unspecified indication, start and stop date were not reported; hctz (HCTZ) taken for an unspecified indication, start and stop date were not reported; metoprolol (METOPROLOL) taken for an unspecified indication, start and stop date were not reported; potassium chloride (K+10) taken for an unspecified indication, start and stop date were not reported.  On 29Jan2021 12:00 the patient experienced she felt severe back pain that moved from her back to her thigh and back again for 1 week on her left side of her body. Patient visited physician office and received treatment for adverse events. The outcome of the events was not recovered.  Follow-up attempts have been completed and no further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Cough, Fatigue, Nausea
Clinical narrative: Swelling; pain at site; Cough; fatigue/tiredness; nausea; fever; pain in all joints; chills; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jan2021 at 13:00 (at the age of 72 years old) (Batch/Lot Number: EL 9261) as single dose for COVID-19 immunisation. Medical history included many allergies, allergy to Iodine, cscan dye. The patient previously took iodine and experienced iodine allergy. Concomitant medication included duloxetine hydrochloride (CYMBALTA). On 22Jan2021 at 01:00, the patient experienced Swelling, pain at site, Cough, fatigue, nausea, fever, pain in all joints, tiredness and chills. No treatment was received for the adverse events and the reporter considered the events as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Swelling, Vaccination site pain
Clinical narrative: Swelling; pain at site; Cough; fatigue/tiredness; nausea; fever; pain in all joints; chills; This is a spontaneous report from a contactable consumer or other non hcp. A 72-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 21Jan2021 at 13:00 (at the age of 72 years old) (Batch/Lot Number: EL 9261) as single dose for COVID-19 immunisation. Medical history included many allergies, allergy to Iodine, cscan dye. The patient previously took iodine and experienced iodine allergy. Concomitant medication included duloxetine hydrochloride (CYMBALTA). On 22Jan2021 at 01:00, the patient experienced Swelling, pain at site, Cough, fatigue, nausea, fever, pain in all joints, tiredness and chills. No treatment was received for the adverse events and the reporter considered the events as non-serious. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. The outcome of the events was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Severe diarrhea; This is a spontaneous report from a contactable consumer (patient herself).   A 61-years-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL 9265), via an unspecified route of administration in arm right on 05Feb2021 at 15:00 (at the age of 61-years-old) as a dose 1, single for COVID-19 immunisation. The patient's medical history was reported as none. The patient was not pregnant at time of vaccination. Allergies to medications, food or other products was reported as no. The patient's concomitant medications within 2 weeks of vaccination was reported as none. No other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19 was reported as no. On 07Feb2021 at 08:00 AM, the patient experienced severe diarrhea. The reporter considered the event as non-serious. Treatment was not received for the event. The outcome of the events was resolved on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pruritus
Clinical narrative: itching; joint soreness; This is a spontaneous report from a contactable consumer (patient herself). A 67-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number and Expiry date was not reported), via an unspecified route of administration on 20Jan2021 as dose 1, single for COVID-19 immunisation. Medical history included a bug sting when she goes outside in her garden, she also gets a lot of itching. The patient's concomitant medications were not reported. It was reported that she got the first dose of the Covid vaccine on 20Jan and got an appointment to get the second dose the day after. She said that she was fine. On 05Feb2021, until 3 days ago, she started lot of itching and joint soreness. She said that the temperature was changing and that might also cause her joint soreness and when she goes outside in her garden and a bug stings her, she also gets a lot of itching. She wanted to know if she should be getting her second dose. Since her doctor does not know much about this, she did not get an advise. The outcome of events was unknown  Information on lot/ batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Diarrhoea, Dysgeusia, Headache, Myalgia
Clinical narrative: muscle aches; headache; sore throat; vertigo; metallic taste; borderline fever; nausea; diarrhea; neck ache; This is a spontaneous report from a contactable consumer (patient). A 74-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration, in left arm 06Feb2021 12:45 (at the age of 74-years-old) as 1st dose, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history was not reported. The patient was allergicto medications, food, or other products, iodine, sulfa, penicillin, codeine and cephalosporins were reported. Concomitant medications received within 2 weeks of vaccination included atorvastatin, sertraline, acetylsalicylic acid (BABY ASPIRIN) and calcium all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 06Feb2021 14:45, the patient experienced muscle aches, headache, sore throat, vertigo, metallic taste, borderline fever, nausea, diarrhea and neck ache. All events reported as non-serious. The patient did not receive any treatment for the event. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Oropharyngeal pain, Pyrexia, Vertigo
Clinical narrative: muscle aches; headache; sore throat; vertigo; metallic taste; borderline fever; nausea; diarrhea; neck ache; This is a spontaneous report from a contactable consumer (patient). A 74-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9269) via an unspecified route of administration, in left arm 06Feb2021 12:45 (at the age of 74-years-old) as 1st dose, single for covid-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was hospital. Medical history was not reported. The patient was allergicto medications, food, or other products, iodine, sulfa, penicillin, codeine and cephalosporins were reported. Concomitant medications received within 2 weeks of vaccination included atorvastatin, sertraline, acetylsalicylic acid (BABY ASPIRIN) and calcium all taken for an unspecified indication, start and stop date were not reported. Prior to vaccination patient was not diagnosed with COVID-19. Since the vaccination the patient had not been tested for COVID-19. The patient did not receive any vaccines within four weeks prior to the vaccination. On 06Feb2021 14:45, the patient experienced muscle aches, headache, sore throat, vertigo, metallic taste, borderline fever, nausea, diarrhea and neck ache. All events reported as non-serious. The patient did not receive any treatment for the event. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: back spasms; This is a spontaneous report from a contactable consumer (patient herself) via Medical Information Team. A female patient of an unspecified age received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- UNKNOWN) via an unspecified route of administration on 03Feb2021 as dose 1, single for COVID-19 immunization. Patient medical history and concomitant medications were not reported. On an specified date in Feb2021, patient stated she had back spasms and when picking up methylprednisolone, pharmacist indicate had vaccine. Also, took Advair but would not be alive without it. Scheduled 24Feb2021 for second dose.  Mentioned husband also takes Advair. The outcome of the event was unknown.   Information on the lot/batch number has been requested.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Angioedema
Clinical narrative: Giant hives; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received the first dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (trade name and manufacturer were not reported; lot number and expiration date were not reported) as a 1st dose, single, with route of administration unspecified, for immunization. Medical history included primary progressive multiple sclerosis; multiple drug intolerance syndrome (with a very long list of allergies) (allergy to anticonvulsants); chronic obstructive pulmonary disease (COPD); optic neuritis; epilepsy; seizures; and pain. Concomitant medications included ibuprofen for pain; and diazepam for seizure. The patient previously took tetanus toxoid for immunization, and had anaphylaxis. On an unspecified date, the patient had giant hives. The outcome of the events was unknown.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Rash, Urticaria
Clinical narrative: Hives; Rash on my nose and below my nose and near bottom lip/ Facial rash; Back of my neck, I had a sharp little pain, stinging sensation; This is a spontaneous report from a contactable consumer (patient, self-reported). A 84-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTEC COVID-19 mRNA VACCINE, Solution for injection, lot number and expiry date were not reported), via an unspecified route of administration, in Arm Left, on 05Feb2021 at 13:30 PM (age at vaccination: 84 year), as a single dose for COVID-19 immunization at hospital or clinic. Vaccine was not administered at military facility. The patient's medical history included COPD, right sided congestive heart failure, pacemaker, AFib, and she has heart problems (she said that were usual for an old woman). Concomitant medications were not reported. The patient did not receive any other vaccine within 4 weeks prior vaccinations. There was no family medical history relevant to adverse event. The patient reported that on 07Feb2021, she had a rash on her nose and below her nose and near bottom lip. On the back of her neck, she had a sharp little pain, stinging sensation on an unspecified date in Feb2021 and she suspected it was the first sign of a rash. Not certain if there was a rash on her neck or not and asked was this a possible reaction to the shot. The patient stated that last night she noticed a scaly patch on her nose that she felt with her finger, then this morning she looked at it good and it was actually a rash, after washing her face she noticed it's not scaly it's a rash, today the rash was between the lip and nose on her face, and on the bottom part of lip, it was slightly tender, and was unusual. On 08Feb2021, she saw rash and hives on the other areas on the face. She assumed her rash was worsening as it was spreading. Her second dose was schedule for 26Feb2021. There were no relevant tests. Outcome of the events was unknown.  Information on the lot/batch number has been requested. Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysphagia, Eye swelling, Feeling abnormal, Gait disturbance
Clinical narrative: Hives; lightheadedness; nausea; throat felt like it was difficult to swallow; broke out in a rash on my chest, arms, face, with swelling around my eyes and rash around my mouth; broke out in a rash on my chest, arms, face, with swelling around my eyes and rash around my mouth; wasn't herself, felt funny; unsteady on feet; face was swollen and still had some splotches on the face the next day after shot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 54-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN5318, expiration date unspecified), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 12:30 as DOSE 1, SINGLE for covid-19 immunization at church (54 year at the time of vaccination). Medical history included hypersensitivity from an unknown date (has had history of allergic reaction), esophagogastroduodenoscopy on an unknown date in 2017. There were no concomitant medications. The patient previously took claritin allergic for seasonal allergy and experienced rash, flu and experienced myalgia, flu and experienced guillain-barre syndrome. The patient was also taking sucralfate and experienced guillain-barre syndrome for an unknown indication since an unknown date in 2017. On 03Feb2021, the patient experienced lightheadedness and nausea with 45 minutes of the dose and her "throat felt like it was difficult to swallow. The patient also reported that within 3 hours she had another episode of these symptoms, broke out in a rash on my chest, arms, face, with swelling around my eyes and rash around my mouth. The patient took Claritin and Benadryl. The next day the swelling and rash were present but diminished. The patient also reported that she wasn't herself and felt funny. The patient left after the observation of 15 minute and walked to the car and was a little unsteady on the feet and had already had a drink in car in case of nausea. The patient also reported that she took half dose of Children's Benadryl since she is susceptible to any medicine, this knocks her out so she just never takes a full adult dose. The patient was treated for the events throat felt like it was difficult to swallow and broke out in a rash on my chest, arms, face, with swelling around my eyes and rash around my mouth with Benadryl and Claritin. The outcome of the events was reported as recovering while it was reported as unknown for hives at the time of report.  Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Rash, Rash macular, Urticaria
Clinical narrative: Hives; lightheadedness; nausea; throat felt like it was difficult to swallow; broke out in a rash on my chest, arms, face, with swelling around my eyes and rash around my mouth; broke out in a rash on my chest, arms, face, with swelling around my eyes and rash around my mouth; wasn't herself, felt funny; unsteady on feet; face was swollen and still had some splotches on the face the next day after shot; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 54-years-old female patient received BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number EN5318, expiration date unspecified), dose 1 via an unspecified route of administration, administered in Arm Left on 03Feb2021 12:30 as DOSE 1, SINGLE for covid-19 immunization at church (54 year at the time of vaccination). Medical history included hypersensitivity from an unknown date (has had history of allergic reaction), esophagogastroduodenoscopy on an unknown date in 2017. There were no concomitant medications. The patient previously took claritin allergic for seasonal allergy and experienced rash, flu and experienced myalgia, flu and experienced guillain-barre syndrome. The patient was also taking sucralfate and experienced guillain-barre syndrome for an unknown indication since an unknown date in 2017. On 03Feb2021, the patient experienced lightheadedness and nausea with 45 minutes of the dose and her "throat felt like it was difficult to swallow. The patient also reported that within 3 hours she had another episode of these symptoms, broke out in a rash on my chest, arms, face, with swelling around my eyes and rash around my mouth. The patient took Claritin and Benadryl. The next day the swelling and rash were present but diminished. The patient also reported that she wasn't herself and felt funny. The patient left after the observation of 15 minute and walked to the car and was a little unsteady on the feet and had already had a drink in car in case of nausea. The patient also reported that she took half dose of Children's Benadryl since she is susceptible to any medicine, this knocks her out so she just never takes a full adult dose. The patient was treated for the events throat felt like it was difficult to swallow and broke out in a rash on my chest, arms, face, with swelling around my eyes and rash around my mouth with Benadryl and Claritin. The outcome of the events was reported as recovering while it was reported as unknown for hives at the time of report.  Follow-up attempts completed. No further information expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Fatigue, Swelling, Vaccination site pain, Vaccination site swelling
Clinical narrative: swelling was increased and spread; very minor pain in the axial area under the arm of the injection site; some minor swelling in that area; fatigue; Minor pain at the injection site; This is a spontaneous report from a contactable consumer (patient). A 36-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9269 and Expiration Date not reported) via an unspecified route of administration, administered in left arm on 05Feb2021 09:30 (at the age of 36 years old) as dose 2, single for COVID-19 immunisation at workplace clinic. The patient medical history included asthma and patient had no known allergies. The patient concomitant medication in two weeks included fluticasone; salmeterol 113/14 inhaler. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL0142 and Expiration Date not reported) via an unspecified route of administration, administered in right arm on 15Jan2021 13:00 (at the age of 36 years old) as dose 1, single for COVID-19 immunisation. The patient did not receive other vaccine in four weeks. The patient did not had covid prior to vaccination. The patient was not tested for COVID post vaccination. Reportedly, after receiving the second vaccine at 9:30 am on 05Feb2021, the patient experienced some fatigue in the evening and minor pain at the injection site. Around 05:00 the morning of the 06Feb2021, the patient noted some very minor pain in the axial area under the arm of the injection site that seemed to stem from some minor swelling in that area. On 08Feb2021, the swelling was increased and spread. The patient did not receive treatment for events. The outcome of events was not resolved.  Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: Having tingling sensation in fingertips, fingernails; general weakness in the arms; This is a spontaneous report from a contactable other healthcare professional (patient). A 45-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL3247), via an unspecified route of administration in the left arm on 27Jan2021 (at the age of 45-year-old) as single dose for COVID-19 immunisation. Medical history included COVID-19 from an unknown date and unknown if ongoing. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient's concomitant medications were not reported. On 28Jan2021, the patient experienced having tingling sensation in fingertips, fingernails and general weakness in the arms starting second day of initial dose. It has been almost 2 weeks since and symptoms not going away. The patient did not receive any treatment for the events. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was reported as not resolved.  Follow-up attempts completed. No further information expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Hyperhidrosis, Myalgia
Clinical narrative: fatigue; chills; sweating; muscle aches; fever that fluctuated up to a maximum of 100 Ffever that fluctuated up to a maximum of 100 F; This is a spontaneous report from a non-contactable consumer.  A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in Arm Left on 05Feb2021 as dose 2, single for COVID-19 immunization. Medical history included anxiety disorder and allergies to sulfa antibiotics. Concomitant medication included sertraline (SERTRALINE) and levothyroxine sodium (THYROXINE).The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 15Jan2021 as dose 1, single for COVID-19 immunization. The patient did not received any other vaccine within 4 weeks of COVID vaccine. The patient did not had COVID prior to vaccination. The patient was not tested for COVID post vaccination. On 06Feb2021, within about 24 hours of receiving the vaccine the patient experienced fatigue, chills, sweating, muscle aches and fever that fluctuated up to a maximum of 100 f. Most of the symptoms subsided within 36 hours of onset except for the fatigue which persisted for 48 hours after onset of the adverse event. The events were not treated. The patient underwent lab tests which included pyrexia: 100 Fahrenheit on 06Feb2021. The patient recovered from events in Feb2021  No follow-up attempts are possible. Information on the Lot/Batch number could not be requested. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: fatigue; chills; sweating; muscle aches; fever that fluctuated up to a maximum of 100 Ffever that fluctuated up to a maximum of 100 F; This is a spontaneous report from a non-contactable consumer.  A 40-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration in Arm Left on 05Feb2021 as dose 2, single for COVID-19 immunization. Medical history included anxiety disorder and allergies to sulfa antibiotics. Concomitant medication included sertraline (SERTRALINE) and levothyroxine sodium (THYROXINE).The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection) via an unspecified route of administration in Arm Left on 15Jan2021 as dose 1, single for COVID-19 immunization. The patient did not received any other vaccine within 4 weeks of COVID vaccine. The patient did not had COVID prior to vaccination. The patient was not tested for COVID post vaccination. On 06Feb2021, within about 24 hours of receiving the vaccine the patient experienced fatigue, chills, sweating, muscle aches and fever that fluctuated up to a maximum of 100 f. Most of the symptoms subsided within 36 hours of onset except for the fatigue which persisted for 48 hours after onset of the adverse event. The events were not treated. The patient underwent lab tests which included pyrexia: 100 Fahrenheit on 06Feb2021. The patient recovered from events in Feb2021  No follow-up attempts are possible. Information on the Lot/Batch number could not be requested. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Mammogram, Rash erythematous, Rash pruritic
Clinical narrative: Itchy red rash from neck to knees; Itchy red rash from neck to knees; This is a spontaneous report from a contactable consumer (patient). A 68-year-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: EL8982), via an unspecified route of administration in Arm Left on 26Jan2021 at 10:45 (at the age of 68-year-old) as single dose for covid-19 immunization. Medical history included Peripheral neuropathy, essential tremor, high BP and cholesterol high. Concomitant medication(s) included pregabalin (LYRICA); topiramate (TOPAMAX); rivaroxaban (XARELTO); atorvastatin (LIPITOR); spironolactone (ALDACTONE); LASIX (FUROSEMIDE), all are taken for an unspecified indication, start and stop date were not reported. The patient previously took flagyl (metronidazole benzoate) and experienced allergy. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, lot number: 6L0140), via an unspecified route of administration in Arm Left on 07Jan2021 at 11:30 (at the age of 68-year-old) as single dose for covid-19 immunization. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 04Feb2021 at 14:00 patient experienced itchy red rash from neck to knees, occurring 10 days after second vaccine. She ate a bowl of new cereal and had never eaten before on this same day, also had a mammogram 3hrs prior to starting to itch. Events were considered non-serious. Patient was not diagnosed with COVID-19 prior to vaccination and not tested for COVID-19 since vaccination. On 04Feb2021, the patient underwent lab tests and procedures which included mammogram with unknown results. Patient received treatment for reported events with Decradron inj, prednisone, benedryl, zyrtex. The outcome of reported events was not recovered.  Follow-up attempts completed. No further information expected.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Overdose, Product preparation error, Tremor
Clinical narrative: 6 individuals received a 0.3ml dose of undiluted Pfizer Covid-19 vaccine; 6 individuals received a 0.3ml dose of undiluted Pfizer Covid-19 vaccine; One individual reported a brief period of chills/shakes; One individual reported a brief period of chills/shakes; This is a spontaneous report from a non-contactable Nurse reported for a patient. An elderly male patient of an unspecified age received an unknown dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Dose: 0.3 mL, Batch/Lot number: unknown, Expiration date: unknown) via an unspecified route of administration, administered at an unspecified anatomical location on 05Feb2021 (age at vaccination was unknown) as unknown, 0.3 ml single for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The facility where the most recent COVID-19 vaccine was administered was Public Health Clinic/Veterans Administration facility. 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. It was reported that 6 individuals received a 0.3ml dose of undiluted Pfizer Covid-19 vaccine. No side effects observed/reported @ 1 hour post-vaccination. One individual reported a brief period of chills/shakes @ 24 hours that quickly resolved. No side effects/adverse effects were observed/reported @ 48 hours post vaccination. No treatment was received for the adverse event. Since the vaccination, the patient has not been tested for COVID-19. The explicit consent was reported as yes. The outcome of the events chills/shakes was resolved on an unknown date in 2021.  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-2021161826 same reporter/drug and different AE/different patient
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Skin lesion, Urticaria
Clinical narrative: Hive like rash on thigh and forehead; Very itchy scalp with bumps on head; Very itchy scalp with bumps on head; This is a spontaneous report from a contactable consumer (patient).  A 79-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration, administered in left arm on 05Feb2021 at 14:00 hours as dose 2, single (at the age of 79-years-old) for COVID-19 immunisation. (Lot unknown reason: Not available/provided to reporter at the time of report completion). Medical history included allergies to sulpha from an unknown date and unknown if ongoing. Patient had no other vaccine in four weeks. Patient had no COVID-19 prior to vaccination. The patient's concomitant medications were not reported. Patient had earlier received first dose of BNT162B2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number and Expiration date: UNKNOWN), via an unspecified route of administration, administered in left arm on 15Jan2021 at 13:00 hours as dose 1, single (at the age of 79-years-old) for COVID-19 immunisation. On 07Feb2021 at 08:00 hours, patient had very itchy scalp with bumps on head and had hive like rash on thigh and forehead. Patient had doctor or other healthcare professional office/clinic visit for all the events. Patient had not been tested for COVID-19, post vaccination. It was unknown if patient received treatment for both the events. The outcome of both the events was unknown. Lot/batch number is not available despite the follow-up attempts made. Follow-up attempts have been completed and no further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Scratch
Clinical narrative: redness; Scratches; itching; This is a spontaneous report from a Contactable Consumer (patient's spouse)   An 80-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via unspecified route of administration on 02Feb2021 as single dose for COVID-19 immunization. Medical history included cardiac arrest, cerebrovascular accident, paralysis all from an unknown date and unknown if ongoing. The patient's concomitant medication was not reported. After receiving the vaccine on 02Feb2021, about three days later on Friday, 05Feb2021 he started with itching, on 07Feb2021 afternoon he had itchy stomach and legs, redness, scratches and hurt himself, his wife has told him not to touch his face; now he has itching and redness on his chest and under his armpit. The reporter would like information to know what she could do because the second dose of his is scheduled for 23Feb2021. The itching was exasperating. The patient could not stop itching. Outcome of the events was reported as Unknown.   Information on the Batch/Lot number has been requested.   Follow-up (11May2021): Follow-up attempts completed. No further information expected.