chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: some aches; This is a spontaneous report from a contactable consumer. This female (patient) consumer reported that: A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Patient reported that she had some aches and stuff after the first dose on an unspecified date. 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 on 09Feb2021 as single dose for covid-19 immunisation and experienced the events headache, nausea, body aches, muscle aches and chills. The outcome of the event was reported as unknown.  Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Diarrhoea, Headache, Malaise
Clinical narrative: patient experienced Fever 102.6; chills; malaise; sore throat; headache; diarrhea; nausea; fever blisters; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9264) dose 1 via an unspecified route of administration in left arm on 06Feb2021 12:00 PM (at the age of 68-year-old) as single dose for COVID-19 Immunization at military base. Medical history included type 2 diabetes, hypertension, breast cancer from 2015. No known allergies. Concomitant medications included metformin, irbesartan (AVAPRO), metoprolol succinate (TOPROL XL), glipizide, methenamine hippurate (UREX), all received in two weeks. No other vaccine received in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Feb2021 02:00 PM the patient experienced fever 102.6, chills, malaise, sore throat, headache, diarrhea, nausea, fever blisters. No treatment received for AE. The outcome of events was recovering.  Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Oral herpes, Oropharyngeal pain, Pyrexia
Clinical narrative: patient experienced Fever 102.6; chills; malaise; sore throat; headache; diarrhea; nausea; fever blisters; This is a spontaneous report from a contactable nurse (patient). A 68-year-old female non-pregnant patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: EL9264) dose 1 via an unspecified route of administration in left arm on 06Feb2021 12:00 PM (at the age of 68-year-old) as single dose for COVID-19 Immunization at military base. Medical history included type 2 diabetes, hypertension, breast cancer from 2015. No known allergies. Concomitant medications included metformin, irbesartan (AVAPRO), metoprolol succinate (TOPROL XL), glipizide, methenamine hippurate (UREX), all received in two weeks. No other vaccine received in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. On 09Feb2021 02:00 PM the patient experienced fever 102.6, chills, malaise, sore throat, headache, diarrhea, nausea, fever blisters. No treatment received for AE. The outcome of events was recovering.  Follow-up attempts completed. No further information expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypersensitivity, Lymphadenopathy, Pain, Pyrexia
Clinical narrative: skin hypersensitivity; High fever; severe body aches; severe headache; Large, painful, swollen lymph nodes; This is a spontaneous report from a contactable nurse (patient). A 45-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; Batch/Lot number was not reported) via an unspecified route of administration on 09Feb2021 at 08:30 (at the age of 45-years-old) in left arm as a single dose for covid-19 immunization. The patient's medical history was reported as none and concomitant medications were not reported. The patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. He had no known allergies. The patient's historical vaccine included first dose of BNT162B2 (COVID Pfizer vaccine) on an unspecified date in Jan2021 at 10:00 in right arm for covid-19 immunization. The patient experienced high fever that took 3-4 hours to break with alternating Tylenol and Motrin, severe body aches, skin hypersensitivity, severe headache, and large, painful, swollen lymph nodes on 09Feb2021 at 16:30. The patient was treated with Tylenol and Motrin for high fever and did not received any treatment for other events. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness near injection site for 24 hours post immunization; This is a spontaneous report received from a contactable consumer (Patient). A 25-years-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EL3247), Solution for injection, via an unspecified route of administration, administered in Arm Left on 09Feb2021 15:30 (at the age of 25-years-old) as single dose for covid-19 immunisation. Medical history was reported as none. The patient's concomitant medications were not reported. Patient had no known allergies. Patient did not receive any other vaccine within four weeks of COVID-vaccine. Patient did not receive any other medication with two weeks. Patient was not diagnosed with COVID-19 prior to vaccination she was not tested for COVID -19 since vaccination. Patient historic vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE for COVID-19 immunisation. On 09Feb2021, the patient experienced soreness near injection site for 24 hours post immunization. No treatment was received to treat adverse events. The event was recovered on an unspecified date in Feb2021.   Follow-up attempts completed. No further information expected.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: really bad stiff neck; sore left arm; This is a spontaneous report from a contactable Nurse reported for herself. A 29-year-old female patient (nurse) received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot number was not reported), dose 1 intramuscular, Administered in Arm Left on 24Jan2021 12:00 (age 29-year-old at the time of vaccination) as DOSE 1, SINGLE for Covid-19 immunisation. There were no medical history and concomitant medications were involved. The patient experienced sore left arm on 24Jan2021 and had a really bad stiff neck on 26Jan2021. Therapeutic measures were taken as Tylenol for both the events. Vaccine was not administered at military facility. Any AE did not required visit to emergency room and physician office. Prior to vaccinations within 4 weeks patient got sore arm with unspecified flu shot, and she did not have the name or lot number of flu shot to provide. The outcome of events for really bad stiff neck was recovered in Jan2021 and for the event sore left arm was recovered in 25Jan2021.  Information about Lot/Batch number has been requested.  Follow-up (11May2021): Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Feeling abnormal, Pyrexia
Clinical narrative: running a fever of 101; felt really bad this morning; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on 09Feb2021 as dose 2, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient previously took bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unknown date as dose 1, single for COVID-19 immunisation. Investigation assessment was not provided. It was reported that she got her second covid shot yesterday, 09Feb2021. She was running a fever "today" (10Feb2021) of 101. She was feeling really bad "this" morning, but now she was feeling much better. She still has a fever. She was supposed to get her grandson "today". She was wondering if it is safe to get him. She does not want to complete a report. She would like to get over to Medical Information. She said her doctor said to treat it like COVID. The patient underwent lab tests and procedures which included fever: 101 (unknown units) on 10Feb2021. The outcome of the events was reported on resolving.  Information on the lot/batch number has been requested.  Follow-up (12May2021): Follow-up attempts completed. No further information expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dry mouth, Dysphagia
Clinical narrative: Issues with swallowing and would always have to swallow; Mouth dry; This is a spontaneous report from a contactable consumer (patient herself). A 76-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL8982; Expiration Date: 20May2021), via an unspecified route of administration, administered in left arm (shoulder) on 22Jan2021 12:00 (age at vaccination: 76 years) as DOSE 1, SINGLE for covid-19 immunisation. The patient's medical history included ongoing rheumatoid arthritis diagnosed 2 to 3 years ago, Blood pressure high from 1980 and ongoing, blood cholesterol, oropharyngeal discomfort. She stated she already has an issue/problem with her throat, gastrooesophageal reflux disease. She has acid reflux on one side of her throat and the other side has a post nasal drop on the other side. At times she would have to swallow. While sleeping at night she had to swallow a lot. She was up throughout the night. She was scared because she had to keep swallowing. Her mouth was also dry and she had to drink a lot of water, upper-airway cough syndrome. Concomitant medication(s) included losartan 25mg once a day taken for blood pressure abnormal from an unspecified start date and ongoing; amlodipine besilate (NORVASC) 5mg once a day, taken for blood pressure abnormal; hydroxychloroquine phosphate (PLAQUENIL), 200mg once a day taken for rheumatoid arthritis and ongoing; atorvastatin (LIPITOR) 10mg once a day, taken for blood cholesterol from an unspecified start date and ongoing. The patient also takes nasal sprays for nasal congestion. The patient did not have any history of previous immunizations with the Pfizer Vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. On 23Jan2021, the patient experienced issues with swallowing and would always have to swallow, mouth was dry at 6am or 7am and may be she was dehydrated. On an unknown date, the patient's blood pressure measurement was high. At first when she got the vaccine she did not feel anything at all. The whole night she was fine. Then she started to have issues overnight. She is due to take the second shot on Friday. She wanted to know if she should drink more water or something. There was no prior vaccinations within 4 weeks. The patient did not require a visit to emergency room or physician's office. The outcome of the events was unknown.  Follow-up attempts are completed. No further information is expected.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: fever; Chills; Headache; fatigue; sore body; This is a spontaneous report from a contactable consumer or other non hcp. A 32-years-old male patient received second dose BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/lot number: EL3247) via an unspecified route of administration in Arm Left on 09Feb2021 14:00 (age at vaccination 32years old) as single dose for covid-19 immunisation. Medical history included food allergy from an unknown date and unknown if ongoing known allergies: Shellfish. The patient had historical of BNT162B2 (COMIRNATY, formulation: Solution for injection, Batch/lot number: EL3247) via an unspecified route of administration in Arm Left on 19Jan2021 14:00 (age at vaccination 32years old) as single dose for covid-19 immunisation. The patient's concomitant medications were not reported. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, the patient had not been tested positive for COVID-19. On 10Feb2021 the patient experienced fever, chills, headache, fatigue, sore body. The patient did not receive any treatment for the adverse events. The clinical outcome of the event was recovering.  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Joint range of motion decreased, Myalgia, Pain in extremity
Clinical narrative: Muscle and joint pain in the right arm; Muscle and joint pain in the right arm from the elbow to the shoulder felt; limited range of motion in arm in all directions; the muscle was being twisted very sore/painful to touch/ arm was tender after injection; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot number: EL9266), via an unspecified route of administration in arm right on 04Feb2021 at 16:00 (at the age of 68-year-old) as a dose 1, single for COVID-19 immunization. The patient's medical history was not reported. The patient's concomitant medication in two weeks included vitamin d [vitamin d nos] and multi vitamins. Other vaccine in four weeks was reported as no. No covid prior vaccination and no covid tested post vaccination. On 08Feb2021 at 17:00, the patient experienced muscle and joint pain in the right arm from the elbow to the shoulder felt as the muscle was being twisted very sore/painful to touch limited range of motion in arm in all directions arm was tender after injection and the symptoms listed above began on 08Feb2021 in the evening, did not start to lesson until 11Feb2021. Treatment was not received for the events. The outcome of the events was recovering.  Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Headache, Myalgia, Swelling
Clinical narrative: Axillary swelling or tenderness; Axillary swelling or tenderness; Headache; Chills; Muscle ache; Pain at the injection site; This is a spontaneous report from a non-contactable consumer or other non HCP (patient). A 47-year-old non pregnant female patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 14:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE (at the age of 47-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The medical history was none and no known allergies. Concomitant medications included fish oil (OMEGA 3 [FISH OIL]) and zinc (ZINC) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included the patient received first dose of bnt162b2 (dose number: 1, administration time: 10:00 AM, vaccine location: Left arm) for covid-19 immunisation on 16Jan2020. The patient experienced pain at the injection site, axillary swelling or tenderness, headache, chills and muscle ache on 10Feb2021 at 04:00. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was reported as recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Axillary swelling or tenderness; Axillary swelling or tenderness; Headache; Chills; Muscle ache; Pain at the injection site; This is a spontaneous report from a non-contactable consumer or other non HCP (patient). A 47-year-old non pregnant female patient received bnt162b2 (BNT162B2, formulation; Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 09Feb2021 14:00 (Batch/Lot number was not reported) as DOSE 2, SINGLE (at the age of 47-year-old) for covid-19 immunisation. The patient was not pregnant at the time of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. The medical history was none and no known allergies. Concomitant medications included fish oil (OMEGA 3 [FISH OIL]) and zinc (ZINC) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Historical vaccine included the patient received first dose of bnt162b2 (dose number: 1, administration time: 10:00 AM, vaccine location: Left arm) for covid-19 immunisation on 16Jan2020. The patient experienced pain at the injection site, axillary swelling or tenderness, headache, chills and muscle ache on 10Feb2021 at 04:00. Since the vaccination, the patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was reported as recovering.  No follow-up attempts are possible. Information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal pain upper, Gastric disorder, Insomnia
Clinical narrative: Bad stomach problem; stomach was hurting; I wasn't able to sleep all night; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on 10Feb2021 at 11:00 (Batch/Lot number were not reported) as dose number unknown, single for COVID-19 immunization. The patient's medical history included food poisoning (after the patient went clean up his system for hours he was fine) Concomitant medication were not reported. On 10Feb2021 at 19:30, the patient experienced bad stomach problem and stomach was hurting. He wasn't able to sleep all night on 10Feb2021. It was reported that on 10Feb2021 about 19:30, the patient started to have bad stomach problem and when he went to the bathroom it was a blood but then there was an interval between that. The patient wasn't able to sleep all night. He reported that he had same experience before when he had food poisoning (similar experience but then after he went clean up his system for hours the patient was fine). It was stated that he done a probably couple of times with blood but this time it looks like it has been 24 hours on my system. The patient was not sure whether or not it was the effect of the medicine or he have another food poisoning. The patient do not know why his stomach was hurting and he was curious if whether or not somebody had reported the same situation as him. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: She said she had a little bit of injection site pain with her first COVID-19 Vaccine shot.; This is a spontaneous report from a contactable consumer (patient). A 76-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247) via intramuscular route of administration in Arm Left on 16Jan2021 17:15 (at the age of 76 years old) as dose 1, single for COVID-19 immunisation. Medical history reported as none. There were no concomitant medications. Patient historical vaccine included Flu shot on an unspecified date and experienced flu for a day (about 10 years ago she had a flu shot, and she had a reaction that felt like she got the flu for a day. No further details provided). The patient experienced as, she said she had a little bit of injection site pain with her first covid-19 vaccine shot on an unspecified date on Jan2021. Outcome of the event was recovered on Jan2021.  Follow-up attempts completed. No further information expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: sore and swollen arm; Fever; headache; nausea; sore and swollen arm; This is a spontaneous report from a contactable non-Consumer. This 68-year-old non-pregnant female consumer reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 11Feb2021 at 04:45 PM on left arm (at 68-year-old), as dose 2, single for COVID-19 immunization. Medical history of the patient included Cholesterols from an unknown date and unknown if ongoing, gastrooesophageal reflux disease from an unknown date and unknown if ongoing, depression from an unknown date and unknown if ongoing and sulfonamide allergy from an unknown date and unknown if ongoing. It was mentioned that no other vaccine was received in four weeks. The patient received other medications in two weeks. The patient did not have covid prior vaccination and was not tested for covid post vaccination. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection; Lot number: unknown) via an unspecified route of administration on 21Jan2021 at 02:45 PM on left arm (at 68-year-old) as dose 1, single for COVID-19 immunization. On 12Feb2021 at 12:00PM the patient experienced fever, headache. slight nausea, sore and swollen arm. No treatment was received for events. The patient was recovering.  No follow up attempts were possible. No further information was expected.
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia, Tremor
Clinical narrative: shaking; Fevers; chills; headache; achiness; This is a spontaneous report from a non-contactable consumer or other non hcp. A 25-years-old male patient received second dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration in Arm Left on 10Feb2021 as DOSE 2, SINGLE for covid-19 immunisation. Patient didn't receive other vaccines within 4 weeks prior to vaccination, patient didn't had covid-19 prior to vaccination. Medical history included drug hypersensitivity(penicillin) from an unknown date and unknown if ongoing, food allergy(seafood) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. Patient was not tested to covid-19 to post vaccination. Patient previously received first dose bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number not reported) via unspecified route of administration in Arm left on 20Jan2021(age at vaccination 25 Years) as DOSE 1, SINGLE for covid-19 immunisation. On 11Feb2021 the patient experienced shaking, fevers, chills, headache, achiness. No therapeutic measures were taken for the events. The outcome of the events tremor, pyrexia, chills, headache, pain was not recovered.  No follow up attempts are possible. Information about lot/batch has been requested. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Fever (100.0F); total body aches; chills; fatigue; This is a spontaneous report from a contactable consumer (patient). A 31-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247) via an unspecified route of administration in Arm Left on 09Feb2021 10:00 (at the age of 31 years old) as dose 2, single for COVID-19 immunisation. The patient medical history was not reported. Concomitant medication(s) taken within two weeks included fluoxetine hydrochloride (PROZAC), colecalciferol (VITAMIN D [COLECALCIFEROL]), linum usitatissimum seed oil (FLAX SEED OIL), and multivitamin, all taken for an unspecified indication, start and stop date were not reported. Patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: EL3247) via an unspecified route of administration in Arm Left on 19Jan2021 10:00 (at the age of 31 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 fever, total body aches, chills, fatigue on 09Feb2021 23:00. No treatment was given for the adverse events. Patient did not tested for COVID post vaccination. The patient underwent lab tests and procedures which included body temperature: 100.0 fahrenheit on 09Feb2021. Outcome of all the events were recovered on Feb2021.  No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Headache; Pain in arm; This is a spontaneous report from a non-contactable consumer (patient). An adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration, administered in the right arm on 11Feb2021 at 12:30 (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation.  Medical history included Graves' disease. The patient has known allergies to penicillin and erythromycin. The patient was not pregnant at the time of the events. The patient did not have COVID prior to vaccination. No other vaccines in four weeks. Concomitant medication(s) included ascorbic acid (VITAMIN C), sambucus nigra fruit (ELDERBERRY), and multi vitamins. On 11Feb2021 at 13:30, the patient experienced headache and pain in arm. No treatment was received for the events. The patient had not been tested for COVID post- vaccination. The outcome of the events was not recovered/not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Nausea, Pyrexia
Clinical narrative: Headaches; High fever; Nausea; This is a spontaneous report received a contactable consumer (patient himself). A male patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 06Feb2021 (Batch/Lot number was not provided) as single dose for COVID-19 immunisation. Medical history included COVID from 2020 to 2020 (Previously had COVID last year). The patient's concomitant medications were not reported. The patient took the first dose of the covid vaccine on Saturday. The patient had reactions of high fever, some nausea, and headaches on an unspecified date in Feb2021 and then that passed. He declined to complete a report. The patient underwent lab tests and procedures which included body temperature: high on Feb2021. Outcome of events was recovering.  Information on the lot/batch number has been requested.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: Had light headache; nausea; pain in left hand; This is a spontaneous report from a contactable consumer (patient herself). A 33-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: EL1283, expiry date: unknown) via unspecified route of administration, administered in left arm on 23Jan2021 (age at vaccination: 33-years) as dose 1, single for Covid-19 immunisation. Patient medical history and concomitant medications were not reported. Patient reported she saw the form, someone gave her the form and she saw Pfizer's number on it to call to report she was having side effects from the Covid vaccine. She had the second shot yesterday and has come down with side effects so bad and she coundnt go to the emergency room due to no insurance. She was unable to provide primary care provider details, had no insurance and needed new provider. After first dose, on an unspecified date, patient experienced as reported: had light headache, nausea, pain in left hand. Patient had no history of problems with vaccines in past. Mentioned she had already missed work and looked to see what Pfizer can do to help her with side effects, looked for medical advice. Talked about a form she saw with help for medical care. Recommended caller for further medical advice to seek medical care, Pfizer was unable to provide medical advice. Vaccination facility type was clinic. No additional vaccines was administered on same date of the Pfizer suspect. There was no history of all previous immunisation with the Pfizer vaccine considered as suspect. The outcome of the events was unknown.   Follow-up (07May2021): Follow-up attempts completed. No further information expected
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Myalgia, Pain in extremity
Clinical narrative: Sore arm; fatigue; sore muscles; This is a spontaneous report from a non-contactable consumer (patient). A 68-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number: EN620159267100002, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 10Feb2021 at 13:00 as dose 2, single for COVID-19 immunisation. Medical history included heart pacemaker installed and known allergies: sulfa, inhibitors penicillin. The patient didn't receive any other vaccines within 4 weeks prior to COVID vaccine. Prior to vaccination, the patient has not been diagnosed with COVID-19. Concomitant medications included amiodarone and levothyroxine sodium (LEVOTHYROXIN) both taken for an unspecified indication, start and stop date were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number: EL324659267100002, Expiration date was not reported), via an unspecified route of administration (administered on the left arm) on 21Jan2021 at 14:00 for COVID-19 immunisation. On 11Feb2021, the patient experienced sore arm, fatigue, and sore muscles. No treatment was received for the events. Since the vaccination the patient has not been tested for COVID-19. The outcome of the events was recovered on an unspecified date in Feb2021.  No follow-up attempts are possible. No further information expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Myalgia, Pain in extremity
Clinical narrative: Muscle pain; Pain in my joints and my lower extremities; Pain in my joints and my lower extremities; This is a spontaneous report from a contactable consumer (patient). A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EL3302, NDC number and Expiration date: Unknown), via an unspecified route of administration, administered in Arm Right on 01Feb2021 (at the age of 74-years-old) as DOSE 1, SINGLE for covid-19 immunisation. Medical history and concomitant medication were not reported. On an unspecified date in Feb2021, the patient experienced muscle pain and pain in my joints and my lower extremities. The patient reported as, "I have had first vaccination with the Pfizer vaccine and that was on Monday like nine days ago and first couple of days I didn't have any reaction but then from last three or four days, I have had muscle pain and pain in my joints and my lower extremities, on an unspecified date in Feb2021. I was just wondering, do you have any idea how long people are reporting that they have these pain and the aches in their legs from the Pfizer." The patient was taking unspecified medication but did not have any chronic problem. The reported stated as, 'Now, the thing is I am only having muscle and joint pain and pain in my lower extremities in my legs not anything else.' No investigation assessment reported. Treatment included Ibuprofen, Tylenol and cannabidiol (CBD) oil as anti-inflammatory medication. Outcome of the events was unknown.  Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Pain, Pain in extremity
Clinical narrative: extremely tired/extremely tired; extremely exhausted; foggy headed; sore arm; fever; chilling; Very achy; This is a spontaneous report from a contactable consumer (patient herself). A 70-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9265), via an unspecified route of administration, administered in right arm on 09Feb2021 10:00 (age at vaccination: 70 years) as Dose 2, SINGLE DOSE for covid-19 immunisation. The patient's medical history included low thyroid, high cholesterol and allergies. The patient previously took Ceclor and penicillin experienced drug hypersensitivity. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261) administered in right arm on 19Jan2021 10:00.  On 09Feb2021 12:00, the patient with in few hours was extremely exhausted, foggy headed, sore arm, fever, chilling and was very achy.  The patient had to sleep most of the day. On 11Feb2021, the patient was extremely tired/extremely tired  On an unknown date (reported as overnight), the patient's pyrexia was 99-101. On 11Feb2021 (reported as Thursday), brain fog lifted and felt able to think again. Also most soreness gone. on 12Feb2021 (reported as today) feel almost back to normal, was very tired. The patient did not have any other vaccine in four weeks. The patient did not receive any treatment for the adverse event. The patient did not have covid prior vaccination nor was tested for covid post vaccination. The outcome of the event fatigue was not recovered, pain was unknown and all the other events were recovered on an unknown date in 2021.  Follow-up attempts completed. No further information expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: extremely tired/extremely tired; extremely exhausted; foggy headed; sore arm; fever; chilling; Very achy; This is a spontaneous report from a contactable consumer (patient herself). A 70-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EL9265), via an unspecified route of administration, administered in right arm on 09Feb2021 10:00 (age at vaccination: 70 years) as Dose 2, SINGLE DOSE for covid-19 immunisation. The patient's medical history included low thyroid, high cholesterol and allergies. The patient previously took Ceclor and penicillin experienced drug hypersensitivity. The patient historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9261) administered in right arm on 19Jan2021 10:00.  On 09Feb2021 12:00, the patient with in few hours was extremely exhausted, foggy headed, sore arm, fever, chilling and was very achy.  The patient had to sleep most of the day. On 11Feb2021, the patient was extremely tired/extremely tired  On an unknown date (reported as overnight), the patient's pyrexia was 99-101. On 11Feb2021 (reported as Thursday), brain fog lifted and felt able to think again. Also most soreness gone. on 12Feb2021 (reported as today) feel almost back to normal, was very tired. The patient did not have any other vaccine in four weeks. The patient did not receive any treatment for the adverse event. The patient did not have covid prior vaccination nor was tested for covid post vaccination. The outcome of the event fatigue was not recovered, pain was unknown and all the other events were recovered on an unknown date in 2021.  Follow-up attempts completed. No further information expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Dry mouth, Dysgeusia, Dyspnoea
Clinical narrative: Fever; spitting up phlegm; weak/no stamina; Short of breath; kidneys hurt a bit; mouth was so dry; appetitive was gone; bad taste in his mouth; This is a spontaneous report from a contactable consumer or other non-hcp (patient). A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 11:00 (at the age of 74 years), (Lot Number: EK4170) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD). There were no concomitant medications. Patient said he got a COVID-19 shot two weeks ago today on 27Jan2021 and was still having stuff. He said he had the regular little stuff like a fever and all that went away, he had a cold and was spitting up phlegm and stuff. He was supposed to get another shot a week from today, but he was not recovered enough from this to get another one, he was weak with no stamina, and was short of breath. Patient also reported his kidneys hurt a bit, which might go away for a little bit, but it came back because his mouth was so dry, he was drinking Gatorade along with water to combat that, his appetitive was gone, and if it did not pick up, he was going to be losing a lot of weight, he eats like a little girl right now. Patient reported to please excuse the expression, but had bad taste in his mouth, there was no way he was going to be recovered enough to take the second dose next week, he was afraid it would kill him. He said he has got COPD, but he regularly goes walking and dancing, and did yard work and all the other stuff. He said he was 74, but right now he feels 95 and ready for the nursing home. He was hoping it will wear off him, but there was no way he could get the shot next week. He had a fever for a little while, but that was gone now. It was just his breathing and stamina, he was not feeling as strong as he usually does. Therapeutic measures were taken as a result of mouth is so dry. The clinical outcome of the events fever was recovered on an unknown date in 2021 and was unknown for other events.   Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Pyrexia, Renal pain
Clinical narrative: Fever; spitting up phlegm; weak/no stamina; Short of breath; kidneys hurt a bit; mouth was so dry; appetitive was gone; bad taste in his mouth; This is a spontaneous report from a contactable consumer or other non-hcp (patient). A 74-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in Arm Left on 27Jan2021 11:00 (at the age of 74 years), (Lot Number: EK4170) as DOSE 1, SINGLE for covid-19 immunisation. Medical history included chronic obstructive pulmonary disease (COPD). There were no concomitant medications. Patient said he got a COVID-19 shot two weeks ago today on 27Jan2021 and was still having stuff. He said he had the regular little stuff like a fever and all that went away, he had a cold and was spitting up phlegm and stuff. He was supposed to get another shot a week from today, but he was not recovered enough from this to get another one, he was weak with no stamina, and was short of breath. Patient also reported his kidneys hurt a bit, which might go away for a little bit, but it came back because his mouth was so dry, he was drinking Gatorade along with water to combat that, his appetitive was gone, and if it did not pick up, he was going to be losing a lot of weight, he eats like a little girl right now. Patient reported to please excuse the expression, but had bad taste in his mouth, there was no way he was going to be recovered enough to take the second dose next week, he was afraid it would kill him. He said he has got COPD, but he regularly goes walking and dancing, and did yard work and all the other stuff. He said he was 74, but right now he feels 95 and ready for the nursing home. He was hoping it will wear off him, but there was no way he could get the shot next week. He had a fever for a little while, but that was gone now. It was just his breathing and stamina, he was not feeling as strong as he usually does. Therapeutic measures were taken as a result of mouth is so dry. The clinical outcome of the events fever was recovered on an unknown date in 2021 and was unknown for other events.   Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigued; This is a spontaneous report from a non-contactable nurse (patient). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on 12Feb2021 as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously vaccinated with the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19, Solution for injection; Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date for COVID-19 immunisation and experienced events which included broke my tooth and infection in gums. The patient was put on antibiotic (amoxicillin) due to infection in gums. The patient experienced fatigued on 12Feb2021. It was reported that the patient felt better after getting the 2nd dose than she did after the 1st dose. The outcome of the event was recovering.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: body ache; headache; This is a spontaneous report from a non-contactable healthcare professional (nurse). A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as dose 1, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced body ache and headache on an unspecified date. The outcome of events was unknown. The patient also received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on an unspecified date for COVID-19 immunisation and experienced leg cramp, body ache, headache and she was not feeling good at all.  No follow up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Muscle spasms, Pain
Clinical narrative: leg cramp; body ache; headache; not feeling good at all; This is a spontaneous report from a non-contactable nurse (patient's colleague) via the Medical Information Team. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), via an unspecified route of administration, on an unspecified date (Batch/Lot number was not reported) as dose 2, single for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient was previously administered the first dose of BNT162B2 on an unspecified date, single for COVID-19 immunisation. The patient experienced leg cramp, body ache, headache, and not feeling good at all on an unspecified date after receiving the second dose. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: redness, heat, tenderness and swelling over the injected area; redness, heat, tenderness and swelling over the injected area; redness, heat, tenderness and swelling over the injected area; swelling over the injected area; This is a spontaneous report from a contactable other hcp based on information received by Pfizer from Galderma. A 53-year-old female patient received second dose of bnt162b2 (PFIZ-ER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 26Jan2021 (at the age of 53-year-old) at dose 2, single for covid-19 immunisation; hyaluronic acid, lidocaine (RESTYLANE L), via an unspecified route of administration from 11Jan2021 to 11Jan2021, at 0.25 mL, via an unspecified route of administration from 26Jan2021 to 26Jan2021, at 0.25 mL, lot number is 17766 (Exp: 31Oct2022) for an unspecified indication. Medical history and concomitant medications were not reported. On 27Jan2021 the patient experienced redness, heat, tenderness and swelling over the injected area. Patient is a 53-year-old female that presented on 11Jan2021 for tear trough filler 0.25 ml of Restylane-L was injected in her bilateral tear troughs. Patient did not have any complaints following that injection. She followed up on 26Jan2021 and had an additional 0.25 ml (the rest of her 0.5 ml syringe) injected in her tear troughs. On the afternoon of 26Jan2021 the patient had her 2nd Covid-19 vaccine. She contacted our office on 28Jan2021 with reports of redness, heat, tenderness and swelling over the injected area. She reports that these symptoms started on 27Jan2021. A Medrol dose pak was prescribed. The patient reports that she only took one day of the medication and symptoms started to resolve. She did not continue the prescription after her first dose. At this point in time (01Feb2021) she is significantly improved and does not seem to have any residual side effects. Action taken with Restylane-L was unknown. Outcome of the events was resolved on an unspecified date in 2021.  Information on the lot/batch number has been requested.  Follow-up (14May2021): Follow-up attempts completed. No further information expected.