chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Soreness and headache; Soreness and headache; Two clusters of blister rashes appeared 5 days after itch started along chest nerve line.; Not painful- assumed mild case of shingles.; Itchy back and right side of chest.; This is a spontaneous report from a contactable consumer (patient).   A 36-year-old non-pregnant female patient second dose of received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8736), via an unspecified route of administration, administered in arm left on 03May2021 10:00 (at the age of 36 years old) as 2nd dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. No known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, Batch/Lot Number: ER8731), dose 1 via an unspecified route of administration, administered in Arm Left on 12Apr2021 10:00 as 1st dose, single dose for COVID-19 immunization. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. On 11May2021, the patient experienced itchiness on back and right side of chest. Not painful- assumed mild case of shingles. Followed by blister rash on 15May2021 in same places. Two clusters of blister rashes appeared 5 days after itch started along chest nerve line. All right side of body. Patient also had Soreness and headache. The treatment received for the not painful- assumed mild case of shingles, itchy back and right side of chest, two clusters of blister rashes appeared 5 days after itch started along chest nerve line was Clobetasol and valacyclovir. The patient underwent lab tests and procedures which included Nasal Swab PCR test: negative on 14Apr2021. The clinical outcome of the events not painful- assumed mild case of shingles, itchy back and right side of chest, two clusters of blister rashes appeared 5 days after itch started along chest nerve line was resolving and events soreness and headache was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Headache, SARS-CoV-2 test
Clinical narrative: headache; This is a spontaneous report from a Pfizer-sponsored program, reported by a contactable consumer (patients wife). A male patient (reporter's husband) received his first dose of BNT162B2 (PFIZER-BIOTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: not reported), unspecified route of administration on 25Apr2021 as 1st dose, single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The reporter and her husband got the first dose last 25Apr2021 and second dose was scheduled on 16May2021. On an unspecified date after the first dose, they took the rapid test and results came back negative. On an unspecified date for a week, the patient had a headache. The reporter was asking if the patient should hold the second dose until the symptoms disappear. The outcome of the event was unknown.   No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at injection site; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age received BNT162B2 (COVID-19 VACCINE - MANUFACTURER UNKNOWN, Solution for injection; Batch/Lot number and Expiration date were not reported), via an unspecified route of administration on an unspecified date as unknown, single dose for COVID-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced soreness at injection site on an unspecified date. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: patient had patch of hives on thigh; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection; trade name reported as "Comirnaty"), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as 1st dose, single dose for COVID-19 immunization. Medical history included allergic reactions (has had allergic reactions before). The patient's concomitant medications were not reported. On an unspecified date, post first Pfizer vaccine for COVID, the patient had patch of hives on thigh with outcome of unknown.   Information on the batch/lot number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Pain; This is a spontaneous report from a Patient Program. A contactable other health care professional and consumer reported that a 60-year-old female patient 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 UNKNOWN, SINGLE DOSE for covid-19 immunisation; tofacitinib citrate (XELJANZ), oral from Jan2021 (Batch/Lot number was not reported) and ongoing, at 5 mg, twice a day for an unspecified indication. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced pain. The outcome of the event was recovered. The action taken in response to the event for tofacitinib citrate was unknown.  Information on the lot/batch number has been requested. Follow up letter has been generated for further information.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 47-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number: ERB 730), via an unspecified route of administration in left arm on 24Apr2021 at 10:45 (at the age of 47-years-old) as 1st dose single dose for COVID-19 immunization. The medical history of patient was reported as no. The patient had no known allergies. The patient concomitant medications were not reported. Patient did not received any other vaccine in four weeks and no other medications in two weeks.. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient not been tested with COVID-19. It was reported that since vaccination the patient was feeling pain in the arm that had been escalating and the arm gets numb and with tingles like it was no circulation on 24Apr2021 at 11:00. The patient reported that he left it over because according to given information, any adverse symptom should disappear in a few days, but up until today it was not, it really worries him since before vaccination he did not have anomalies in his arm, the patient scheduled an appointment at the clinic for next Wednesday to get his arm revised because this was happening for almost a month. It was reported that no treatment was taken as a result of adverse events. The outcome of events was not recovered.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Fatigue, Feeling abnormal, Headache
Clinical narrative: a rise on her blood pressure; nausea; headache; tiredness; sleepiness; neck cramps; Feels the medication in her mouth and nose; she was sick all week for almost 7 days; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179), via an unspecified route of administration on 01May2021 at 12:00 (at the age of 62-year-old), as 1st dose, single dose in left arm for COVID-19 immunization at pharmacy/drug store. The patient's medical history included ongoing diabetes, high blood pressure, ongoing hypothyroidism, COVID-19 in Jan2021, ongoing high cholesterol and her nose had allergies before. Concomitant medications included Vitamin D NOS, Ferrous sulfate, Losartan 12.5 mg once a day, Levothyroxine 100ug once a day for thyroid, Metformin for diabetes, Glimepiride 0.25 half morning and half at night for diabetes, Atorvastatin once a day. The patient's historical vaccine included tetanus vaccine taken long time ago and experienced sore arm. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021, 12 hours after vaccination, the patient experienced a rise on her blood pressure and took Losartan as treatment medication. On the fifth day, she went to physician's office and doctor advised her to take Amlodipine 2.5mg. After the medication she doesn't feel it very much and therefore, doctor added new medication. Then the patient had done her blood pressure measurement, which showed low 114 or something. Patient was not okay and she checked it every 3-4 hours and it was high. On 02May2021, 12 hours after vaccination, the patient also experienced nausea, headache, tiredness, sleepiness, and neck cramps. Patient took medication for nausea problem. On 01May2021, the patient was sick all week for almost 7 days and felt that the medication was in her mouth and nose. These events stopped on 08May2021 after a duration of 7 days. The patient stated that neck cramps and headache kept coming and going. The patient was so scared to take the second dose. The patient was tested positive for COVID on Jan2021, and she waited 3 months before getting the first dose of vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: very high on 02May2021 and 114 after new medication on an unspecified date; SARS-CoV-2 test: positive on an unspecified date in Jan2021. The clinical outcome of the event nausea was resolved on an unspecified date and outcome of the event feels the medication in her mouth and nose was resolved on 08May2021. The clinical outcome of the event neck cramps was resolving and outcome of the event she was sick all week for almost 7 days was unknown. The clinical outcome of all other events was not resolved.  Follow up item are needed. Further information is excepted.  No Follow-up attempts completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Muscle spasms, Nausea, SARS-CoV-2 test, Somnolence
Clinical narrative: a rise on her blood pressure; nausea; headache; tiredness; sleepiness; neck cramps; Feels the medication in her mouth and nose; she was sick all week for almost 7 days; This is a spontaneous report from a contactable consumer (patient). A 62-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0179), via an unspecified route of administration on 01May2021 at 12:00 (at the age of 62-year-old), as 1st dose, single dose in left arm for COVID-19 immunization at pharmacy/drug store. The patient's medical history included ongoing diabetes, high blood pressure, ongoing hypothyroidism, COVID-19 in Jan2021, ongoing high cholesterol and her nose had allergies before. Concomitant medications included Vitamin D NOS, Ferrous sulfate, Losartan 12.5 mg once a day, Levothyroxine 100ug once a day for thyroid, Metformin for diabetes, Glimepiride 0.25 half morning and half at night for diabetes, Atorvastatin once a day. The patient's historical vaccine included tetanus vaccine taken long time ago and experienced sore arm. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 02May2021, 12 hours after vaccination, the patient experienced a rise on her blood pressure and took Losartan as treatment medication. On the fifth day, she went to physician's office and doctor advised her to take Amlodipine 2.5mg. After the medication she doesn't feel it very much and therefore, doctor added new medication. Then the patient had done her blood pressure measurement, which showed low 114 or something. Patient was not okay and she checked it every 3-4 hours and it was high. On 02May2021, 12 hours after vaccination, the patient also experienced nausea, headache, tiredness, sleepiness, and neck cramps. Patient took medication for nausea problem. On 01May2021, the patient was sick all week for almost 7 days and felt that the medication was in her mouth and nose. These events stopped on 08May2021 after a duration of 7 days. The patient stated that neck cramps and headache kept coming and going. The patient was so scared to take the second dose. The patient was tested positive for COVID on Jan2021, and she waited 3 months before getting the first dose of vaccine. The patient underwent lab tests and procedures which included blood pressure measurement: very high on 02May2021 and 114 after new medication on an unspecified date; SARS-CoV-2 test: positive on an unspecified date in Jan2021. The clinical outcome of the event nausea was resolved on an unspecified date and outcome of the event feels the medication in her mouth and nose was resolved on 08May2021. The clinical outcome of the event neck cramps was resolving and outcome of the event she was sick all week for almost 7 days was unknown. The clinical outcome of all other events was not resolved.  Follow up item are needed. Further information is excepted.  No Follow-up attempts completed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles on back after second dose; This is a spontaneous report from a contactable consumer (patient). A 62-years-old female patient received BNT162B2(PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8732), dose 2 via an unspecified route of administration, administered in left arm on 01May2021 12:00 as 2nd dose, single dose (at the age of 62-years-old); and previously received BNT162B2(Lot Number: EW0150), dose 1 via an unspecified route of administration, administered in left arm on 10Apr2021 14:00 as 1st dose, single dose for COVID-19 immunization. No history of any previous vaccinations within 4 weeks. The patient's medical history and concomitant medications were not reported. Patient reported some people in her family had Chicken-pox. On 18May2021, after second dose, the patient experienced shingles on back which is ongoing at the time of report. Patient developed Shingles and did not think it was related to the vaccine. And patient does not think it is a coincidence that other people are developing Shingles, and maybe the vaccine is activating something inside of their body. No Investigation Assessment. Patient reports she was taking medication for shingles. Patient had a video doctor's visit. The outcome of event was unknown.  Follow up needed, further information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021576867 same reporter/drug/event, different patient;US-PFIZER INC-2021576866 same reporter/drug/event, different patient
Sex: U
Vaccine: COVID19, UNK
Symptoms: Lethargy, Pain
Clinical narrative: Lethargic; tremendously achy/ body pain; This is spontaneous report from a contactable consumer (patient). A patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunisation and methotrexate sodium for Rheumatoid arthritis. Medical history included Rheumatoid arthritis. Concomitant medications were unknown. The patient experienced lethargy, tremendously achy/ body pains on unknown date. The outcome of the events was unknown. Follow up are needed. Information about lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021577670 same reporter/drug/event, diff patients
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Breast swelling, Chills, Insomnia, Migraine
Clinical narrative: The 2nd shot very bad migraine; chills; sore arm; swollen armpit; swollen breast all right side, very painful; swollen breast all right side, very painful; couldn't sleep; constance ache and shooting pain to my nipple on this right side; back swollen; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0170), dose 2 via an unspecified route of administration, administered in Arm Right on 27Apr2021 14:00 (at the age of 56-year) as 2nd dose, 0.3 ml single dose for COVID-19 immunization. Medical history was none provided (Patient history: No). Concomitant medication(s) included LISINOPRIL, OMEPRAZOLE; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and LORATADINE taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). The patient previously received first dose of BNT162B2 (Batch/Lot Number: EW0158) via an unspecified route of administration, administered in Arm left on Apr2021 02:00 PM (at the age of 56-year), 0.3 ml for COVID-19 immunization and experienced migraine, sore arm on the left side the 1st shot. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient stated, both shots very bad migraine a mile sore arm on the left side the 1st shot. The 2nd shot very bad migraine chills and sore arm (29Apr2021 at 12:00) Wednesday the day after. Thursday morning 2nd shot swollen armpit, swollen breast all right side, very painful all day Thursdays all night thursday couldn't sleep (29Apr2021 12:00). Friday the swelling had my right side to the center of my back swollen (2021). Call my doctor went in that friday afternoon she stated it was a reaction to the shot my lymph Nodes. that Saturday and Sunday I couldn't put my bra on due to the swelling. The medication I was giving help some with the swelling and pain. On Monday the next the swelling is not the same but as of today I am still swollen and have a different pain it's more of a constance ache and shooting pain to my nipple on this right side (2021). armpit and breast very swollen. Treatment (Medication) was used for adverse events. Patient visited Doctor or other healthcare professional office/clinic for events. Therapeutic measures were taken as a result of the 2nd shot very bad migraine, chills, sore arm, swollen armpit, swollen breast all right side, very painful , couldn't sleep, constance ache and shooting pain to my nipple on this right side, back swollen. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nipple pain, Pain in extremity, Swelling
Clinical narrative: The 2nd shot very bad migraine; chills; sore arm; swollen armpit; swollen breast all right side, very painful; swollen breast all right side, very painful; couldn't sleep; constance ache and shooting pain to my nipple on this right side; back swollen; This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0170), dose 2 via an unspecified route of administration, administered in Arm Right on 27Apr2021 14:00 (at the age of 56-year) as 2nd dose, 0.3 ml single dose for COVID-19 immunization. Medical history was none provided (Patient history: No). Concomitant medication(s) included LISINOPRIL, OMEPRAZOLE; fluticasone propionate (FLONASE [FLUTICASONE PROPIONATE]) and LORATADINE taken for an unspecified indication, start and stop date were not reported (received within 2 weeks of vaccination). The patient previously received first dose of BNT162B2 (Batch/Lot Number: EW0158) via an unspecified route of administration, administered in Arm left on Apr2021 02:00 PM (at the age of 56-year), 0.3 ml for COVID-19 immunization and experienced migraine, sore arm on the left side the 1st shot. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was other. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient stated, both shots very bad migraine a mile sore arm on the left side the 1st shot. The 2nd shot very bad migraine chills and sore arm (29Apr2021 at 12:00) Wednesday the day after. Thursday morning 2nd shot swollen armpit, swollen breast all right side, very painful all day Thursdays all night thursday couldn't sleep (29Apr2021 12:00). Friday the swelling had my right side to the center of my back swollen (2021). Call my doctor went in that friday afternoon she stated it was a reaction to the shot my lymph Nodes. that Saturday and Sunday I couldn't put my bra on due to the swelling. The medication I was giving help some with the swelling and pain. On Monday the next the swelling is not the same but as of today I am still swollen and have a different pain it's more of a constance ache and shooting pain to my nipple on this right side (2021). armpit and breast very swollen. Treatment (Medication) was used for adverse events. Patient visited Doctor or other healthcare professional office/clinic for events. Therapeutic measures were taken as a result of the 2nd shot very bad migraine, chills, sore arm, swollen armpit, swollen breast all right side, very painful , couldn't sleep, constance ache and shooting pain to my nipple on this right side, back swollen. The outcome of events was not recovered.  No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity, Tenderness
Clinical narrative: Upper arm is extremely tender; Upper arm is extremely painful; cannot lift it above shoulder height due to pain; This is a spontaneous report from a contactable consumer (patient). A 38-years-old male patient received first dose of bnt162b2 (Pfizer BioNTech, formulation: solution for injection, Lot Number: EW0167), via an unspecified route of administration, administered in right arm on 20May2021 11:30 (at the age of 38-years-old) as single dose for COVID-19 immunisation. Medical history included ongoing SSRI discontinuation syndrome which would come back whenever he was sick and apparently also from the vaccine and ongoing electric brain zaps when he would get sick or have a temperature ever since he was a child and was taken off of paroxetine cold turkey which induced electric brain zaps and they went away at that time but continued having them lifelong whenever he would get sick, and also in response to this vaccine which felt like a jolt of electricity in the brain. The patient had no other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient was not COVID tested post vaccination. The patient had no known allergies. Concomitant medications included lorazepam; diazepam; paroxetine and bisoprolol. The patient previously took paroxetine. On 21May2021 at 01:00, the patient experienced upper arm was extremely tender, painful and could not lift it above shoulder height due to pain. It was unknown if the patient received treatment for the events. Outcome of the events was unknown.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This is a spontaneous report from a contactable consumer via company representative. A patient of an unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced flu like symptoms post first dose. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from contactable other Hcp (Pharmacist) from a Pfizer sponsored program . A 25-years-old female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: Unknown), via an unspecified route on May2021 as 1st dose, single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient did not took other products. On unspecified date, the patient experienced shingles. She is on an oral antiviral treatment for shingles. She mentioned that the shingles was already on the peak when the patient consulted with the doctor and was only prescribed the regimen recently. She is asking for how long should they wait before giving the COVID vaccine. Reporter wants to knew when would be a good time for the patient to receive her second dose because the patient is on oral antiviral treatment for shingles due to being on antiviral for another 4 days. Reporter stated that the shingles infection happened between the first dose and the second dose and he couldn't confirm when the patient received the first dose and when the shingles exactly happened. The reporter mentioned that the patient was already taking those oral antivirals at the peak of the infection because the infection was already going on before she consulted with her doctor and was prescribed with the oral antiviral treatment. Reporter stated that what she does know is that the patient was further along in the virus, it was not the beginning of the shingles. Reporter unsure of when patient received the first dose, stating it was sometime in the beginning of May2021 she would think and states she was scheduled for the second dose on 24May2021. The outcome of event was unknown.   Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Activated partial thromboplastin time prolonged, Contusion, Haematoma, Viral infection
Clinical narrative: virus; hematomas; huge bruise; This is a spontaneous report received from a contactable consumer via Medical Information Team. A 80-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as single dose for Covid-19 immunization. The patient's medical history and concomitant medications were not reported. Reporter stated her mother had virus, hematomas and huge bruise. 80Y. Mentioned to the hematologist. Health care professional declined association with vaccination. The patient had test with clotting factors similar to Heparin/Warfarin. A month and a half post vaccination, partial thromboplastin time (PTT), numbers were elevated. The reporter was really concerned and spoke with someone at medical team. The reporter stated that infection better have immunity than vaccination and stated that people who had a previous infection do not need to be vaccinated. The reporter stated that not susceptible to malaria and knew genetically speaking some people are susceptible. Referred to HCP. Attempted to warm transfer to DSU. Caller stated she did not have information. No PQC present. Outcome of the events was unknown.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: mild soreness at the injection site; This is a spontaneous report from a contactable consumer (patients mother). A 14-year-old male patient received BNT162B2 (formulation: solution for injection, Lot number: Unknown) via an unspecified route of administration on an unspecified date as unknown dose number, single dose for covid-19 immunization. The patient's medical history and concomitant medications were not reported. It was reported that patient received the Pfizer vaccine that afternoon on an unknown date and developed mild soreness at the injection site. The outcome of event was unknown.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes, Rash, Toothache
Clinical narrative: got full on mouth cold sores; severe face rash; teeth hurting; This is a spontaneous report from a contactable consumer.   A 51-year-old non pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 mRNA vaccine, Formulation: Solution for injection, Lot number: EW0168 and expiration date were not reported) dose 2, via an unspecified route of administration in left arm, on 14May2021 at 09:15 AM (at the age of 51-year-old) as single dose for COVID-19 immunization. The patient medical history included jaw rewired 20 years ago. Concomitant medications were received (unspecified). The patient previously received first dose of BNT162B2 (COMIRNATY; Solution for injection; Lot number: EW0171) unspecified route of administration, administered in left arm on 22Apr2021 at 11:15 AM as single dose for COVID-19 immunization experienced her lower jaw and lower teeth began to hurt and legs got hives for a couple of days. The patient did not receive other vaccine in four weeks. The patient did not take vaccination prior to covid and not tested covid post vaccination. In May2021, the patient got full on mouth cold sores. She never got them in warm months, abreva always tamps it out in a day. But the cold sore so much bigger. Then a week later, she got and still have severe face rash. She never had this kind of rash in her life. The patient's cold sore and face rash and teeth hurting are still ongoing. The patient did not take any treatment for the events. The outcome o the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Stated the first shot hurt but that was it; This is a spontaneous report from a non-contactable female consumer (the patient) from a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE, lot number not provided), via an unspecified route of administration on an unspecified date as a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient got her first dose and was supposed to get her second dose tomorrow; she wanted to know if she should make an appointment. She stated the first shot hurt, but that was it. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymphadenopathy, Musculoskeletal stiffness, Neoplasm, Pyrexia
Clinical narrative: Stiffness of the muscles of the back, legs and arms, fever, chills, swollen glands, lumps in the neck.; Stiffness of the muscles of the back, legs and arms, fever, chills, swollen glands, lumps in the neck.; Stiffness of the muscles of the back, legs and arms, fever, chills, swollen glands, lumps in the neck.; Stiffness of the muscles of the back, legs and arms, fever, chills, swollen glands, lumps in the neck.; Stiffness of the muscles of the back, legs and arms, fever, chills, swollen glands, lumps in the neck.; This is a spontaneous report from a contactable consumer (patient) or other non hcp. A 38-years-old non-pregnant female patient received first dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot Number: ER8733) via an unspecified route of administration, administered in arm left on 01May2021 13:15 as 1st dose, single dose and patient also received other vaccination on the same day as dose 2 via an unspecified route of administration, administered in arm left on 01May2021 13:15 (Batch/Lot Number: EP5733) as 2nd dose, single dose for covid-19 immunization. Medical history and concomitant medications were not reported. Patient had no known allergies. Patient did not take any other medications in two weeks. Patient did not receive any other vaccine within 4 weeks. Patient neither diagnosed with COVID-19 prior to vaccination nor been tested for COVID-19 after the vaccination. On 04May2021 02:00, the patient experienced stiffness of the muscles of the back, legs and arms, fever, chills, swollen glands and lumps in the neck. Patient was not received any treatment for the events. The outcome of the events was not recovered.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Rash
Clinical narrative: developed a rash on my chest and one arm; headache; chills; Second dose administered on 11May2021 (First dose on 30Apr2021); This is a spontaneous report from a contactable consumer (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), second dose at the age of 56-years-old via an unspecified route of administration, administered in arm left on 11May2021 (Batch/Lot Number: 0167) as 2nd dose, single dose for covid-19 immunisation. The patient's medical history was not reported. The patient did not have covid prior to vaccination. Concomitant medications included levothyroxine sodium; simvastatin (SIMVASTIN); biotin and ubidecarenone (COQ10), all taken for an unspecified indication, start and stop date were not reported. The patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) at the age of 56-years-old on 30Apr2021 10:00 (batch/lot number: 8735) administered in left arm for covid-19 immunisation. The patient reported that the day after her second shot on 11May2021, she had a headache and chills on 12May2021 which went away after 12 hours after taking Aleve. Then on 19May2021, she developed a rash on her chest and one arm. Pharmacist has recommended Benadryl to resolve situation. Therapeutic measures were taken as a result of the events which included Aleve and Benadryl. The patient recovered from headache and chills on an unspecified date (reported as 12 hours after taking Aleve) while the patient was recovering from rash on her chest and one arm. The patient was not tested post vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: joint pain/ pain in right shoulder; my right upper arm was very sore; This is a spontaneous report from a contactable consumer or other non hcp (patient). A patient of unspecified age and gender received first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine, Formulation: solution for injection, Batch/Lot Number unspecified, expiration date unspecified), via an unspecified route of administration, administered in Arm Left on 15Feb2021 as 1ST DOSE, SINGLE DOSE for covid-19 immunization. The patient medical history and concomitant medications were not reported. On 16Jan2021, post vaccination next day the patient right upper arm was very sore. On an unknown date the patient had joint pain/ pain in right shoulder. The outcome of the events was reported as unknown at the time of report.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Loss of personal independence in daily activities, Pain, Vomiting
Clinical narrative: terrible diarrhea; terrible throwing up; pain started, right shoulder, left shoulder, right shoulder so painful couldn't lift arm to move the mouse on my laptop without the help of my left hand, bicep, knees wrist, left hand; pain started, right shoulder, left shoulder, right shoulder so painful couldn't lift arm to move the mouse on my laptop without the help of my left hand, bicep, knees wrist, left hand; I had exhaustion and could not lift either arm; This is a spontaneous report from a contactable consumer or other non hcp. A patient of unspecified age and gender received second dose of bnt162b2 (BNT162B2, Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 08Mar2021 as second dose, single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On Mar2021 the patient experienced terrible diarrhoea, terrible throwing up, the pain started, right shoulder, left shoulder, right shoulder so painful I couldn't lift my arm to move the mouse on my laptop without the help of my left hand, then it went to other areas, bicep, knees wrist, left hand so painful I couldn't play, I had exhaustion and could not lift either arm. It is been 10 weeks and still having side effects. The outcome of the events was unknown.  Information about batch/lot number has been requested.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Pain in extremity, Ultrasound thyroid, Weight
Clinical narrative: Sore arm; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection; lot number: EW0168), via an unspecified route of administration, administered in the left arm on 05May2021 (at the age of 68-years-old) as 1st dose, single dose for COVID-19 immunization. Medical history included ongoing hyperthyroidism, heart racing up from 23Apr2021 and ongoing, fast heartbeat from 23Apr2021 and ongoing, high blood pressure increased from 23Apr2021 and ongoing, weight loss, tremor from 23Apr2021 and ongoing, hospitalization from 24Apr2021 to 25Apr2021. Concomitant medications included ongoing methimazole taken for heart racing up and fast heartbeat ongoing; and clonidine taken for high blood pressure. The patient previously took propranolol, atenolol, and metoprolol and experienced drug intolerance with all three drugs. In Mar2021, the patient was diagnosed with hyperthyroidism. She had been diagnosed previously with hyperthyroidism over 30 years ago. The patient lost weight in February or March, she lost 20-something pounds in a short time. On 23Apr2021 23:00, the patient had her heart racing up, her blood pressure has been up, had an irregular fast heartbeat, and tremors. The racing heartbeat was on and off. She took a medicine for it. Her heart in the morning was 100 beats per minute. Her blood pressure shot up really high which went down to normal after 30 minutes, and she got tremors when it happened. It happened at night, it didn't happen every night, but once or twice. The tremors didn't last long and were a little better after the start of the medicine. They were less frequent. The patient's blood pressure goes up once a while. She stays away from salt. She has some Clonidine she had taken a few times when her blood pressure went really high. Her blood pressure was pretty much stable otherwise. The patient went to the emergency room as she thought she was having a heart attack. She was kept in the ER until about 01:00 of 24Apr2021 and was admitted to the hospital from 24Apr2021 to 25Apr2021. In the hospital, thyroid ultrasound was performed with unknown result. The patient has been to the physician's office several times since. The patient did not receive any other vaccinations within four weeks prior to the COVID-19 vaccination. On 05May2021, in the afternoon (reported as 13:00 or 13:30), the patient received her first dose of BNT162B2. Afterwards, all she experienced was a sore arm. The patient wanted to know if she should hold off getting the 2nd dose until her hyperthyroidism and other symptoms (fast heartbeat, high blood pressure, tremors, and weight loss) are under control - the patient had all these before the 1st dose and was still experiencing them. The outcome of the event was unknown.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Energy increased, Feeling abnormal, Illness, Neck pain
Clinical narrative: The knee and his neck are still in pain; The knee and his neck are still in pain; sick; his neck had always caused him grief; his energy level increased; Unexpected therapeutic benefit.; This is a spontaneous report from a contactable consumer (patient). A 68-year-old-male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9269, Expiry Date and NDC number: unknown), via intramuscular in left arm on 12Feb2021, as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6205, Expiry Date: Unknown, NDC number unknown), via an unspecified route of administration in right arm on an unspecified date, as 2ND DOSE, SINGLE DOSE on 05Mar2021 for COVID-19 immunization. The patient underwent a knee surgery in Dec2020. Patient received the Pfizer BioNTech COVID-19 vaccine (30 days after contracting the virus) after testing negative for the virus. Patient mentioned that the virus attacked his joints but did not alter his taste and smell. Concomitant medications were not reported. After receiving the Pfizer BioNTech COVID-19 vaccine, patient stated that some side effects from the virus minimized, improvement was noticed, joints did not hurt as bad and energy level increased. Patient's experience after receiving the Pfizer BioNTech COVID-19 vaccine had been pretty positive. Patient was healing well, but once he caught the virus everything, they did to fix his knee turned bad. Patient had to have a complete knee replacement now because of the COVID-19 Virus. While he was sick, he had just had knee surgery and his neck had always caused him grief, and the virus exacerbated all of that. The knee and his neck were still in pain. After he got the vaccine, some of those effects from the virus had reduced, they were not gone entirely, but there was an improvement. Patient felt an improvement, but he still had residual symptoms from the virus. Pfizer BioNTech COVID-19 vaccine helped alleviate some symptoms from the COVID virus. The outcome of all events was recovering. Investigation Assessment: No  Follow-up attempts are completed. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative, Therapeutic response unexpected
Clinical narrative: The knee and his neck are still in pain; The knee and his neck are still in pain; sick; his neck had always caused him grief; his energy level increased; Unexpected therapeutic benefit.; This is a spontaneous report from a contactable consumer (patient). A 68-year-old-male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EL9269, Expiry Date and NDC number: unknown), via intramuscular in left arm on 12Feb2021, as 1ST DOSE, SINGLE DOSE for COVID-19 immunization. The patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot Number: EN6205, Expiry Date: Unknown, NDC number unknown), via an unspecified route of administration in right arm on an unspecified date, as 2ND DOSE, SINGLE DOSE on 05Mar2021 for COVID-19 immunization. The patient underwent a knee surgery in Dec2020. Patient received the Pfizer BioNTech COVID-19 vaccine (30 days after contracting the virus) after testing negative for the virus. Patient mentioned that the virus attacked his joints but did not alter his taste and smell. Concomitant medications were not reported. After receiving the Pfizer BioNTech COVID-19 vaccine, patient stated that some side effects from the virus minimized, improvement was noticed, joints did not hurt as bad and energy level increased. Patient's experience after receiving the Pfizer BioNTech COVID-19 vaccine had been pretty positive. Patient was healing well, but once he caught the virus everything, they did to fix his knee turned bad. Patient had to have a complete knee replacement now because of the COVID-19 Virus. While he was sick, he had just had knee surgery and his neck had always caused him grief, and the virus exacerbated all of that. The knee and his neck were still in pain. After he got the vaccine, some of those effects from the virus had reduced, they were not gone entirely, but there was an improvement. Patient felt an improvement, but he still had residual symptoms from the virus. Pfizer BioNTech COVID-19 vaccine helped alleviate some symptoms from the COVID virus. The outcome of all events was recovering. Investigation Assessment: No  Follow-up attempts are completed. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: very tired; sore arm; This is a spontaneous report from a non-contactable other healthcare professional. A male patient of an unspecified age received BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Lot/batch no: unknown) via unspecified route, as unknown, single dose on 22Mar2021 for COVID-19 immunization (at the age of 36-years). Medical history included chronic myeloid leukaemia, pancreatitis acute, Chronic Idiopathic urticaria, MALS released post op complications (bleeding), hepatic ischaemia, cholecystectomy, VATS decussation bil lungs, plurex bil lungs and ongoing idiopathic urticaria. The patient's concomitant medications were not reported. On unspecified date it was reported that patient experienced very tired & Sore arm. The clinical outcome for the event was unknown.  Follow up needed, further information has been requested.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Allergy to vaccine, Drug hypersensitivity, Erythema, Face oedema, Joint swelling
Clinical narrative: extremely congested; right wrist and forearm swollen; red and swollen; allergic reaction to the vaccine/histamine reaction; left side of his face swollen and puffy in lips, chin and cheek; left side of his face swollen and puffy in lips, chin and cheek; left hand swollen and itchy/forearm swollen; left hand swollen and itchy; allergic reaction to the vaccine/histamine reaction; This is a spontaneous report from a contactable consumer (patient). A 45-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 23May2021 12:50 (at age of 45 year old, reported as "was Given: 12:50pm, right before 1:00pm", Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient not had medical history and family medical history. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration, administered in left arm on 02May2021 12:50 (at age 45 years old, reported as "was Given: 12:50pm, right before 1:00pm", Batch/Lot number was not reported) as single dose for covid-19 immunization.  Patient had the second dose of the Pfizer COVID-19 vaccine last Sunday (23May2021). Since then, he thinks he had an allergic reaction to the vaccine. On 26May2021 (Wednesday late morning, early afternoon), he woke up and the left side of his face was all swollen and puffy in the lips, chin and cheek. It started out in the lower cheek and then kind of spread through out the day. It eventually went down to the lower lip on the left side and moved up to the upper lip on the left side. His face was still swollen but to a much less degree. He took Benadryl and it kind of went away and was getting better. His left hand was all swollen and itchy now. It started after but was simultaneous with the face swelling. On 27May2021, he woke up this morning and his right wrist and forearm was swollen. Not really a rash but was red and swollen, and looks like a histamine reaction. Right wrist and forearm swollen was reported as worsened. He had been extremely congested the past 2 days. Was extremely congested with 99 percent blockage. He took Afrin which knocked it out. It was better but he was still very congested. No physician office visited. He was at Urgent Care right now. The outcome of the events "left side of his face swollen and puffy in lips, chin and cheek; extremely congested" was recovering. The outcome of other events was unknown.  Information on lot/batch number has been requested.