chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: 14 days after vaccine I started severe diarrhea; severe joint aches; Coughing; 4 Days after I had a strange headache for 2 days; then felt fatigue; fever of 99 for an afternoon; noticed lungs seemed different as breathless, which progressed to a little pressure which I have never had before; This is a spontaneous report from a contactable consumer or other non-hcp (Patient). A 76-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection; Lot Number: EN6203) via an unspecified route of administration (age at vaccination 76-year) in right arm on 28Feb2021 at 01:15 PM as dose 1, single for COVID-19 immunization. Medical history included diverticulitis; SOD; emphysema; Known allergies: several drugs, bee/wasp stings, msg, most preservatives; all from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID); tiotropium bromide (SPIRIVA RESPIMAT); vitamin c [ascorbic acid] (VITAMIN C [ASCORBIC ACID]); vitamin d nos (VITAMIN D NOS); all taken in two weeks of COVID vaccination, for an unspecified indication, start and stop date were not reported. The patient received no COVID prior vaccination. The patient not tested COVID post vaccination. Patient received no other vaccine in four weeks. Reported facility type vaccine was Doctor's office/urgent care. The patient experienced 4 days after she had a strange headache on 04Mar2021 for 2 days; then felt fatigue, fever of 99 for an afternoon, noticed lungs seemed different as breathless, which progressed to a little pressure which she never had before, on an unspecified date in Mar2021; 14 days after vaccine she started severe diarrhea, severe joint aches, coughing, on 14Mar2021. It was reported that "She never had before though, she had emphysema. Called her physician and she said to not take scheduled second shot when scheduled on 14Mar2021. Then she was concerned of what's next." AE resulted in Doctor or other healthcare professional office/clinic visit. The patient underwent lab tests and procedures on an unspecified date which included body temperature: 99 (fever of 99). The patient received no treatment for the adverse events. The clinical outcome of the events was not resolved.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Erythema, Furuncle, Investigation, Pyrexia
Clinical narrative: boil under his right arm; boil under his right arm was reported as worsened; redness on his right arm; fever; This is a spontaneous report from a contactable consumer. This consumer reported for a 62-Year-old male patient (husband) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EN6206), via an unspecified route of administration, administered in arm right on 06Mar2021 as dose number unknown, single for COVID-19 immunization (age at vaccination: 62-Year-old). Medical history included COVID-19 from on an unspecified date in Mar2020. The patient's concomitant medications were not reported. On 07Mar2021, the patient had big red boil on his arm and fever. Stated that it has gotten worst, and it is next to the breast. Also stated that when they did the test that he had already had COVID and that he thought he had the flu, and it was COVID. It was reported that he found out two months later when he had the test. Timeframe between vaccination and starting of symptoms was 01 day. The patient did not receive any treatment for the adverse events. The patient underwent lab tests and procedures which included blood test: unknown results (stated that they take his blood out every three months because it is heavy) and test included: COVID (stated that when they did the test that he had already had COVID). The patient recovered from fever on 07Mar2021. The outcome of events boil under his right arm, boil under his right arm was reported as worsened and redness on his right arm was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Gait disturbance, Heart rate, Heart rate increased, Oral herpes
Clinical narrative: Dizziness; Rapid Heartbeat; tremors; vertigo; inability to walk well; cold sores around nose; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in Arm Right on 22Feb2021 11:00 (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included heart disease, neurological vascular, EPI, degenative disc disease from an unknown date and unknown if ongoing, known allergy: Penicillin, Iodine dye from an unknown date and unknown if ongoing. Concomitant medication(s) included clonazepam (KLONOPIN); atorvastatin (LIPITOR [ATORVASTATIN]); warfarin sodium (COUMADIN); omeprazole (PROTONIX [OMEPRAZOLE]) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), all taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). Facility where COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Post vaccination, the patient had not been tested for COVID-19. On 22Feb2021 11:15, patient experienced dizziness, rapid heartbeat, tremors, vertigo, inability to walk well, cold sores around nose. Patient visited doctor or other healthcare professional office/clinic, emergency room/department or urgent care for adverse events. The patient underwent lab tests and procedures which included heartbeat: rapid on 22Feb2021. The clinical outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Tremor, Vertigo
Clinical narrative: Dizziness; Rapid Heartbeat; tremors; vertigo; inability to walk well; cold sores around nose; This is a spontaneous report from a contactable consumer (patient). A 65-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot Number: EN6198), dose 1 via an unspecified route of administration, administered in Arm Right on 22Feb2021 11:00 (at the age of 65-year-old) as dose 1, single for COVID-19 immunization. Medical history included heart disease, neurological vascular, EPI, degenative disc disease from an unknown date and unknown if ongoing, known allergy: Penicillin, Iodine dye from an unknown date and unknown if ongoing. Concomitant medication(s) included clonazepam (KLONOPIN); atorvastatin (LIPITOR [ATORVASTATIN]); warfarin sodium (COUMADIN); omeprazole (PROTONIX [OMEPRAZOLE]) and cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), all taken for an unspecified indication, start and stop date were not reported (Other medications in two weeks). Facility where COVID-19 vaccine was administered at hospital. The patient did not receive any other vaccine in 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient diagnosed with COVID-19 was unknown. Post vaccination, the patient had not been tested for COVID-19. On 22Feb2021 11:15, patient experienced dizziness, rapid heartbeat, tremors, vertigo, inability to walk well, cold sores around nose. Patient visited doctor or other healthcare professional office/clinic, emergency room/department or urgent care for adverse events. The patient underwent lab tests and procedures which included heartbeat: rapid on 22Feb2021. The clinical outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Rash pruritic
Clinical narrative: itchy red rash on my chest and arms; very red, hot face; very red, hot face; This is a spontaneous case received from a contactable consumer (patient herself). A 34-year-old female patient received first dose of bnt162b2 (BNT162B2, PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection, lot number: EN6205) via an unspecified route of administration in left arm on 11Mar2021 17:40 (age at vaccination 34-year-old) as DOSE 1, SINGLE for COVID-19 immunisation. The patient was not pregnant at the time of vaccination. The patient's medical history included thrombocytopenia and 3 months postpartum/breastfeeding. Concomitant medications included aminobenzoic acid, biotin, calcium pantothenate, choline bitartrate, cyanocobalamin, folic acid, inositol, nicotinamide, pyridoxine hydrochloride, riboflavin, thiamine mononitrate (B COMPLEX [AMINOBENZOIC ACID, BIOTIN, CALCIUM PANTOTHENATE, CHOLINE BITARTRATE, CYANOCOBALAMIN, FOLIC ACID, INOSITOL, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE MONONITRATE]), SELENIUM, VITAMIN C [ASCORBIC ACID], VITAMIN D NOS, ZINC, GoatsRue, Shatavari. The patient had known allergies with sulfa drugs, apple/pear and diary. Other vaccine administered in four weeks was reported as none. COVID prior vaccination and COVID tested post vaccination was reported as none. On 12Mar2021 09:10, the patient stated that she received the vaccine at 5:45 PM on Thursday, at Friday morning at 9:10 AM had a very red, hot face. Ten minutes later she had an itchy red rash on her chest and arms. No fever, she could breath find and it went away after an hour or so. No treatment was taken for the events. Outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information was expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Swelling
Clinical narrative: Patient received vaccine and felt neck swelling and chest tightness.; Patient received vaccine and felt neck swelling and chest tightness.; This is a spontaneous report from a contactable Health Care Professional. A 60-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection, Batch/Lot Number: EN6203), dose 1 intramuscularly on 26Feb2021 at 15:30 (at the age of 60-years-old) as a DOSE 1, SINGLE for covid-19 immunisation at Health Clinic facility. The patient medical history included rhinitis allergic, hypersensitivity, glucose tolerance impaired, headache, hyperlipidaemia, food allergy (fish and seeds/nuts) and gastroesophageal reflux disease all from an unknown date and unknown if ongoing. Concomitant medications included albuterol [salbutamol] (ALBUTEROL [SALBUTAMOL]) 90 ug, TID (Three times a day) (albuterol 90 mcg/inh inhalation aerosol) 4 puff), fexofenadine hydrochloride (ALLEGRA), naproxen sodium (ALEVE) 220 mg, once a day orally, biotin (BIOTIN) as needed orally, colecalciferol (VITAMIN D 3) once a day, epinephrine (EPINEPHRINE) (EpiPen 2-Pak 0.3 mg injectable kit) 1 each (0.3 mg) Intramuscularly, garlic [allium sativum] (GARLIC [ALLIUM SATIVUM]) orally (garlic oral capsule), lisinopril (LISINOPRIL) (lisinopril 10 mg oral tablet; 1 tab 10 mg) orally, lysine (LYSINE) 1000 mg, once a day orally and probiotics (PROBIOTICS) once a day (3-10 billion CFUs) orally, all were taken for an unspecified indication, start and stop date were not reported. It was unknown if the patient received other vaccine in four weeks. It was unknown If patient had covid prior vaccination and If tested for covid post vaccination. The patient received vaccine and felt neck swelling and chest tightness on 26Feb2021 at 15:45. It was reported that, 1538 Patient received vaccine and felt neck swelling and chest tightness. Patient received treatment for the event which was reported as, patient refused Benadryl and stated it knocks her out. Patient took 2 puffs of her prescribed Albut. Outcome of the event was resolved in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Body temperature, Chest X-ray, Chest pain, Chills
Clinical narrative: Woke up this morning with debilitating pain across middle of back; Every breath caused severe pain; low grade fever (100.7); chills; This is a spontaneous report from a contactable consumer or other non hcp.   A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 10:30 (age at vaccination 42 years old) (Batch/Lot Number: EN6203) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history was not reported. There were no concomitant medications. Historical Vaccine BNT162B2 product=COVID 19, lot unknown=False, dose number=1 age at vaccination 42 years old, for COVID-19 immunisation. on 09Mar2021 01:00 The patient experienced woke up this morning with debilitating pain across middle of back Every breath caused severe pain. Went to ER and received Toradol. Came home and developed low grade fever (100.7) and chills. AE treatment with Toradol and Tylenol.  The patient underwent lab tests and procedures which included body temperature: 100.7 Fahrenheit on 09Mar2021 developed low grade fever (100.7), chest x-ray: negative on 09Mar2021 Chest X-rays negative. Therapeutic measures were taken as a result of woke up this morning with debilitating pain across middle of back (back pain), every breath caused severe pain (chest pain), low grade fever (100.7) (pyrexia), chills (chills). Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Woke up this morning with debilitating pain across middle of back; Every breath caused severe pain; low grade fever (100.7); chills; This is a spontaneous report from a contactable consumer or other non hcp.   A 42-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 03Mar2021 10:30 (age at vaccination 42 years old) (Batch/Lot Number: EN6203) as DOSE 2, SINGLE for covid-19 immunisation.  The patient medical history was not reported. There were no concomitant medications. Historical Vaccine BNT162B2 product=COVID 19, lot unknown=False, dose number=1 age at vaccination 42 years old, for COVID-19 immunisation. on 09Mar2021 01:00 The patient experienced woke up this morning with debilitating pain across middle of back Every breath caused severe pain. Went to ER and received Toradol. Came home and developed low grade fever (100.7) and chills. AE treatment with Toradol and Tylenol.  The patient underwent lab tests and procedures which included body temperature: 100.7 Fahrenheit on 09Mar2021 developed low grade fever (100.7), chest x-ray: negative on 09Mar2021 Chest X-rays negative. Therapeutic measures were taken as a result of woke up this morning with debilitating pain across middle of back (back pain), every breath caused severe pain (chest pain), low grade fever (100.7) (pyrexia), chills (chills). Outcome of the events was not recovered.  No follow-up attempts are possible. No further information is expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Throat tightness
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 50-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number: Unknown, and Expiration date: Unknown), via an unspecified route of administration, administered in left arm on 12Mar2021 08:30 (at the age of 50-year-old) as dose 1, single for COVID-19 immunization, at other facility. The patient medical history included fibromyalgia. Concomitant medications included gabapentin (GABAPENTIN), spironolactone (SPIRONOLACTONE), and duloxetine hydrochloride (CYMBALTA). The patient had no known allergies. The patient received no other vaccine in four weeks. The patient did not have COVID prior vaccination. The patient was not tested for COVID post vaccination. On 12Mar2021 08:30, the patient experienced chest and throat tightness along with dizziness. No treatment was given for the events. The outcome of the events was reported as not resolved. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Arthralgia, Asthenia, Fatigue, Gastrooesophageal reflux disease
Clinical narrative: Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; This is a spontaneous report from a non-contactable other hcp (patient). A 27-year-old (non-pregnant) female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Mar2021 14:30 (at the age of 27-year-old) at dose number unknown, single for covid-19 immunisation. Medical history included Chronic migraines, GERD. Patient had no known allergies. Patient did not have covid prior vaccination. Patient has not tested for covid-19 post vaccination. Patient did not have other vaccine in four weeks. Concomitant medications were not reported. On 05Mar2021 the patient experienced Extreme fatigue, weakness, drowsiness, joint pains, Myalgia's, GERD, sweats, ABD pain. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment for the adverse events. Outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Myalgia, Somnolence
Clinical narrative: Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; Extreme fatigue, weakness, drowsiness, joint pains, myalgias, GERD, sweats , abd pain; This is a spontaneous report from a non-contactable other hcp (patient). A 27-year-old (non-pregnant) female patient received bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 MRNA VACCINE; Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on 05Mar2021 14:30 (at the age of 27-year-old) at dose number unknown, single for covid-19 immunisation. Medical history included Chronic migraines, GERD. Patient had no known allergies. Patient did not have covid prior vaccination. Patient has not tested for covid-19 post vaccination. Patient did not have other vaccine in four weeks. Concomitant medications were not reported. On 05Mar2021 the patient experienced Extreme fatigue, weakness, drowsiness, joint pains, Myalgia's, GERD, sweats, ABD pain. Adverse events resulted in doctor or other healthcare professional office/clinic visit. Patient received treatment for the adverse events. Outcome of the events was not resolved.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Neck mass
Clinical narrative: I noticed a lump closer to my neck than my shoulder; This is a spontaneous report from a contactable consumer (patient) reported for herself that. A 65-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 13Mar2021 09:30 (Batch/Lot Number: EN6206) as DOSE 2 SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. The History of all previous immunization with the Pfizer vaccine First dose of the product was administered on 14Feb2021. The patient did not receive any other vaccine within 4 weeks prior to covid-19 vaccination. The patient Received her second dosage on Saturday morning and states she has developed a lump near my neck, left, between my shoulder and her neck, closer to her neck on 14Mar2021.  It's real swollen and it's tender to the touch and it's on the same side she had her shot.  Caller wants to know if that is one of the side effects, could it possibly be one, has anyone else had one, or is it something else. Caller states she tried contacting her doctor first, but he is completely booked for the week. The event outcome was not recovered.  Follow-up attempts are completed. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Eye swelling, Hypersensitivity, Nasal oedema, Pruritus
Clinical narrative: cheeks and nose turning red and was warm to the touch, by that evening, the redness spread but was there was no swelling; cheeks and nose turning red and was warm to the touch, by that evening, the redness spread but was there was no swelling; cheeks and nose turning red and was warm to the touch, by that evening, the redness spread but was there was no swelling; my face was red with hives very warm to the touch itchy and extremely swollen especially around cheeks and eyes.; my face was red with hives very warm to the touch itchy and extremely swollen especially around cheeks and eyes.; my face was red with hives very warm to the touch itchy and extremely swollen especially around cheeks and eyes.; having an allergic reaction; This is a spontaneous report from a contactable consumer. This 43-year-adult female consumer reported that.  A 43-year-old (non-pregnant) female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 14Mar2021 11:45 (at the age of 43-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Peanuts allergy from an unspecified date and unknown ongoing and concomitant medications includes Metronidazole and Minerals Nos, Quercetin, Thioctic Acid, Vitamins Nos (EMERGEN-C). On 14Mar2021, 4 hours after the vaccination, the patient experienced cheeks and nose turning red and was warm to the touch, by that evening, the redness spread but was there was no swelling. When patient woke up in the morning, face was red with hives very warm to the touch itchy and extremely swollen especially around cheeks and eyes. ER DR confirmed was having an allergic reaction. Received a few shots and medication to take as treatment. Patient was not diagnosed with covid prior vaccination and covid was not tested post vaccination. The outcome of the events was recovering.  No follow-up attempts possible. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: cheeks and nose turning red and was warm to the touch, by that evening, the redness spread but was there was no swelling; cheeks and nose turning red and was warm to the touch, by that evening, the redness spread but was there was no swelling; cheeks and nose turning red and was warm to the touch, by that evening, the redness spread but was there was no swelling; my face was red with hives very warm to the touch itchy and extremely swollen especially around cheeks and eyes.; my face was red with hives very warm to the touch itchy and extremely swollen especially around cheeks and eyes.; my face was red with hives very warm to the touch itchy and extremely swollen especially around cheeks and eyes.; having an allergic reaction; This is a spontaneous report from a contactable consumer. This 43-year-adult female consumer reported that.  A 43-year-old (non-pregnant) female patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: unknown, Expiration date: unknown), via unspecified route, administered on 14Mar2021 11:45 (at the age of 43-year-old) as dose 1, single for COVID-19 immunization. The patient medical history includes Peanuts allergy from an unspecified date and unknown ongoing and concomitant medications includes Metronidazole and Minerals Nos, Quercetin, Thioctic Acid, Vitamins Nos (EMERGEN-C). On 14Mar2021, 4 hours after the vaccination, the patient experienced cheeks and nose turning red and was warm to the touch, by that evening, the redness spread but was there was no swelling. When patient woke up in the morning, face was red with hives very warm to the touch itchy and extremely swollen especially around cheeks and eyes. ER DR confirmed was having an allergic reaction. Received a few shots and medication to take as treatment. Patient was not diagnosed with covid prior vaccination and covid was not tested post vaccination. The outcome of the events was recovering.  No follow-up attempts possible. No further information expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Herpes zoster, Inflammation, Pain in extremity, Tenderness
Clinical narrative: The nerve on the backside of my leg was inflamed to the back of my knee; Outbreak of herpes; Tenderness in the nerve on the left side of my face; Occasional pain in my left ear; Sore arm; This is a spontaneous report received from a contactable consumer or other non-health care professional (patient reported for herself). A 69-years-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 05Mar2021 14:15 (at the age of 69-years-old) as dose 1, single for COVID-19 immunisation. Medical history included lumbar discectomy, low back pain with bilateral sciatica, degenerative disc from an unknown date and unknown if ongoing degenerative disc. The patient concomitant medications were not reported. Patient not had Known allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Since the vaccination, did not patient been tested for COVID-19. The patient did not receive other medications in two weeks of vaccination. Other than a sore arm on 05Mar2021, I had no reaction on the Friday that I received the shot. I also have herpes which breaks out in the hairline of my forehead and on the back side of my right buttocks. The day after the vaccine on Saturday, On 06Mar2021 the nerve on the backside of my leg was inflamed to the back of my knee, I also had an outbreak of herpes in both areas and tenderness in the nerve on the left side of my face with occasional pain in my left ear. The nerve pain in my leg and face subsided by Monday, the bilateral sciatic pain thru my buttocks area on both sides has not dissipated as of yet. Patient visited doctor or other healthcare professional office/clinic visit. Treatment was received for the events (recommendation to hear, stretch and elevate). The outcome of the events was reported as recovering.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Mildly sore arm after the first and second shot; This is a spontaneous report from a contactable consumer. A contactable consumer (patient) reported for a himself. A male patient of an unspecified age received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; solution for injection, Lot Number: UNKNOWN), dose 1 via an unspecified route of administration on an unspecified date as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient experienced mildly sore arm after the first and second shot on an unspecified date. No medical questions about side effects at this time. Outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: I got my shot 2 weeks ago today and i have metallic taste in my mouth.; This is a spontaneous report from a contactable consumer or other non-health care professional (patient). A 76-years-old female patient received 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 01Mar2021 as dose number unknown, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On an unspecified date in Mar2021, the patient experienced I got my shot 2 weeks ago today and i have metallic taste in my mouth. It started about 1 week ago. Is that a side effect. The clinical outcome of the events was reported as unknown.  Follow-up attempts completed. No further information expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Insomnia, Oropharyngeal pain, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 84-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 10Mar2021 (at the age of 84-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller mentioned that she received the 1st dose of the vaccine on 10Mar2021 and had a lot of problems since she got that shot. She mentioned that on the day she received it, she was okay and just had a sore arm. She mentioned that a day after, she had a headache for 6 days, was tired that she was on and off her couch, had chills, and could not eat because her mandibular joint on the right side of her jaw hurt. She could not chew, not even toast, so she resulted to drinking coffee and sipping soup. She had no good sleep because of it. She did not had a temperature or any dental problems. She said that her mouth was still hurting, she still had a sore throat. It was so bad that she would not wish it on her worst enemy. Because of this, she was very worried about the 2nd dose. She was asking what to expect of it and would it be similar. she was due for it on 31Mar2021. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: This is a spontaneous report from a contactable consumer (patient herself). A 84-years-old female patient received first dose of bnt162b2 (Pfizer-BioNTech Covid-19 Vaccine, Solution injection; Batch/Lot number was not reported), via an unspecified route of administration on 10Mar2021 (at the age of 84-years-old) as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. Caller mentioned that she received the 1st dose of the vaccine on 10Mar2021 and had a lot of problems since she got that shot. She mentioned that on the day she received it, she was okay and just had a sore arm. She mentioned that a day after, she had a headache for 6 days, was tired that she was on and off her couch, had chills, and could not eat because her mandibular joint on the right side of her jaw hurt. She could not chew, not even toast, so she resulted to drinking coffee and sipping soup. She had no good sleep because of it. She did not had a temperature or any dental problems. She said that her mouth was still hurting, she still had a sore throat. It was so bad that she would not wish it on her worst enemy. Because of this, she was very worried about the 2nd dose. She was asking what to expect of it and would it be similar. she was due for it on 31Mar2021. The outcome of the events was unknown. Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: She reports a swollen lymph node on the same side as injection; This is a spontaneous report from a contactable consumer (patient herself). A 49-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number: unknown, expiry date: unknown) via unspecified route of administration on 22Feb2021, as dose 1, single for covid-19 immunisation. Patients medical history and concomitant medications were not reported. Patient reported noticing a swollen lymph node on her collar bone on the same side that she received the vaccine on 04Mar2021. She was due for her second shot, today, but her HCP told her to wait another week to see if the swelling in her lymph node will go down. Do we have information about duration of swollen lymph nodes? Lymphadenopathy is a commonly reported AE in the clinical trials, but the frequencies we have reported are from the 7 days post either dose. No information for duration. The outcome of event was unknown.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Blood urine present, Malaise, Renal disorder
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 55-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 2021 as dose 1, single for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced as, she felt "really sick, kidney damage, blood in her urine, her stomach is "really bad on 2021. Reported as, Patient got the first dose of Pfizer vaccine 2 weeks ago, does not remember exact day. She felt "really sick", it looks like she had kidney damage, she had blood in her urine, she had a "very bad" reaction. The last two weeks she has been to 5 different hospitals, because they know nothing about the vaccine o how to help her. She was prescribed antibiotics, her stomach was "really bad", she still has kidney problems. On Wednesday, she was scheduled for the second dose. Treatment were given for the adverse event. Outcome of the event kidney damage was not recovered and unknown for other events. No follow up attempts are possible. Information about Lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: he had a sore arm for a couple of days; This is a spontaneous report from a contactable consumer (patient). This male consumer reported for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection. Batch/Lot number was not reported), dose 1 via an unspecified route of administration on 08Mar2021 as DOSE 1, SINGLE for COVID-19 immunization. Medical history included skin ulcer from an unknown date and unknown if ongoing ulcer on his leg. Concomitant medication included valaciclovir hydrochloride (VALTREX) taken for skin ulcer (for an ulcer on his leg) start and stop date were not reported. The patient experienced a sore arm for a couple of days. Patient wanted to know, patient took Valtrex daily and prophylactically, for an ulcer on leg, and it will affect the efficacy of the vaccine. Response: no drug interactions listed in the fact sheet (Sect 10). Provided the two classes of medication that are contraindicated in the attached document. The outcome of the event was unknown.    Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm for 2-3 days; This is a spontaneous report from a contactable consumer reported for a 86-year-old male consumer (patient) that received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced sore arm for 2-3 days. What were the titer cut off levels during the trial. Caller got an antibody test with a reference point of .8 and a measurement of 250. What does this mean. Caller received second dose of Pfizer vaccine on 10Feb2021 and experienced no side effects. The clinical outcome of event was unknown. Information on the lot/batch number has been requested. Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: she is on a blood thinner and received the first dose of the Pfizer-BioNTech COVID-19 vaccine; Severe Diarrhea; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient reported for herself). A 74-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: EN6208), dose 1 via an unspecified route of administration, administered in right arm on 11Mar2021 at 11:00 (at the age of 74-year-old) as dose 1, single for COVID-19 immunisation at other facility. Medical history included hypertension from an unknown date and unknown if ongoing, irritable bowel syndrome from an unknown date and unknown if ongoing. The patient's concomitant medications within 2 weeks of vaccination included blood pressure (BP) medications and blood thinner. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not diagnose with COVID-19 prior to vaccination. The patient had not been tested for COVID-19 since the vaccination. On 13Mar2021 at 13:00, the patient experienced severe diarrhea. It was reported that the patient stated she was on a blood thinner and received the first dose of the Pfizer-BioNTech COVID-19 vaccine. She explained she was told after the fact that she should tell the vaccination provider about being on a blood thinner. The event had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. No treatment was received for the event. Not allowed to contact healthcare professional. No product quality complaint was present. Expiration date has been requested. The outcome of the event was reported as resolving.  Follow-up attempts completed. No further information expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain, Eye irritation, Nasal congestion, Nasopharyngitis
Clinical narrative: Mild headache around sinuses and back of head; cold symptoms (very mild congestion, mild eyes burning); cold symptoms (very mild congestion, mild eyes burning); cold symptoms (very mild congestion, mild eyes burning); mild chest discomfort (similar to acid reflux/GERD which I have a history of).; chest pain (thought was related to my GERD condition); This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 25Feb2021 13:45 (Lot number was not reported) (at the age of 54-years-old) as dose 1, single for covid-19 immunisation. Medical history included gastroesophageal reflux disease (GERD), mild mitral valve prolapse. There were no concomitant medications received within two weeks of vaccination. The patient did not receive any other vaccine in four weeks of vaccination. The patient did not have covid-19 prior to vaccination and was tested for covid-19 post vaccination. On 04Mar2021, the patient experienced mild headache around sinuses and back of head and cold symptoms, very mild congestion, mild eyes burning and mild chest discomfort similar to acid reflux/GERD which she had a history of. The symptoms began about a week after first vaccine dose and were present 1.5 weeks later. The patient was preoccupied with possibly having caught COVID during that time and the chest pain in Mar2021, she thought was related to her GERD condition. The patient had polymerase chain reaction (PCR) test by nasal swab on 10Mar2021 and the result was negative. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The outcome of chest pain was unknown and outcome of all other events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinus headache
Clinical narrative: Mild headache around sinuses and back of head; cold symptoms (very mild congestion, mild eyes burning); cold symptoms (very mild congestion, mild eyes burning); cold symptoms (very mild congestion, mild eyes burning); mild chest discomfort (similar to acid reflux/GERD which I have a history of).; chest pain (thought was related to my GERD condition); This is a spontaneous report from a contactable consumer (patient). A 54-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 25Feb2021 13:45 (Lot number was not reported) (at the age of 54-years-old) as dose 1, single for covid-19 immunisation. Medical history included gastroesophageal reflux disease (GERD), mild mitral valve prolapse. There were no concomitant medications received within two weeks of vaccination. The patient did not receive any other vaccine in four weeks of vaccination. The patient did not have covid-19 prior to vaccination and was tested for covid-19 post vaccination. On 04Mar2021, the patient experienced mild headache around sinuses and back of head and cold symptoms, very mild congestion, mild eyes burning and mild chest discomfort similar to acid reflux/GERD which she had a history of. The symptoms began about a week after first vaccine dose and were present 1.5 weeks later. The patient was preoccupied with possibly having caught COVID during that time and the chest pain in Mar2021, she thought was related to her GERD condition. The patient had polymerase chain reaction (PCR) test by nasal swab on 10Mar2021 and the result was negative. The adverse event resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive treatment for the events. The outcome of chest pain was unknown and outcome of all other events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Eye irritation, Eye pain, Eye pruritus, Eye swelling
Clinical narrative: swollen; little tumor on the eyelid; pain in her eye; eye was irritated; left eye tumor red and itching; left eye tumor red and itching; This is a spontaneous report from a contactable consumer (patient). A 80-years-old female patient received second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EN6205), via an unspecified route on 11Mar2021 at 09:30 (at the age of 80-years) as dose 2, single in the left arm for covid-19 immunisation. The patient medical history included anxiety diagnosed a long time ago, diabetes from 1958 to ongoing, blood pressure high diagnosed 10 or 13 years ago, high cholesterol diagnosed since the caller was in her 40's and got the shingles vaccine before, family history her mother had glaucoma. The patient concomitant medications were not reported. The patient historical vaccine included BNT162b2 Covid 19 shot (Batch/lot number: EN9267) and experienced eye was very red and itchy and swollen, very dry tongue and mouth and used refresh eye drops for her eyes but she stopped using them and got a Flu shot last Sep. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 11Mar2021, the patient experienced left eye tumour red and itching. Patient received the first shot and she got strong side effects in her right eye, she doesn't know if it's the shot. The patient eye was very red and itchy and swollen. The patient also had a very dry tongue and mouth. The patient was planning on going to the pharmacy in a little while to ask for something for her eye. The patient first shot was 17Feb2021 and then on the right eye it looked like a small tumour, that is severe. Today 11Mar2021 the patient went for her second shot and on the other eye, her left eye, it's like a little tumour on the eyelid, red and very itchy and has to keep from scratching it all the time. The patient was going to the pharmacy right now to get something for her eye. The patient other eye, the right eye, was clear already, she's hoping her left eye will clear up like this. After the second dose the side effect is her left eye, sometimes she feels pain in her eye and sometimes she doesn't, if she closes it or applies pressure she feels pain. The itch is worse, than when the patient got the shot she didn't have the itch and now it started itching when she got home. The patient eye was irritated. The patient got blood test about 2.5 months ago but that was before she received the vaccines. Patient did not visit to Emergency room or Physician's office. Lately the patient had been suffering from her eyes, she had some condition where she thought her eyes were closed but they weren't but this was from a medication which she stopped taking and it hadn't happened since, she was given the wrong medication for her illness. The outcome of the events left eye tumour red and itching was not recovered and other events was unknown.  No follow up attempts are possible. No further information is expected.