chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Had headache not all the time but every once in a while; Have chills every once in a while; tired; This is a spontaneous report received from a contactable consumer or other non hcp. A 72-years-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot/Batch number: EL9265, Pfizer NTEC), via an unspecified route of administration on 02Feb2021 as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The reporter stated that she had some reactions and that is not that they were but she concerned about herself and she had headache not all the time but every once in a while, have chills every once in a while and she tired, unusually tired on an unspecified date. Therapeutic measures were taken as a result of Had headache not all the time but every once in a while, Have chills every once in a while and tired and treatment included TYLENOL. The outcome of the events was reported as recovered on an unspecified date.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: excruciating pain in her arm; can't lift or rotate her arm more than 5 degrees; This is a spontaneous report from a contactable consumer (patient). A 45-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 2 via an unspecified route of administration, administered in arm on 17Feb2021 (lot number: EM9810) as SINGLE DOSE for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. The patient previously took the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247) for COVID-19 immunization. On 17Feb2021 17:00, the patient started to feel the symptoms. The patient had an excruciating pain in her arm and can't lift or rotate her arm more than 5 degrees. Therapeutic measures were taken as a result of the events which included treatment with Advil and ice. The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: right arm is aching; This is a spontaneous report from a contactable consumer. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation Solution for injection, Lot number and expiration date was not reported) via an unspecified route of administration on 12Feb2021 as Single dose for covid-19 immunisation. The patient medical history was not reported. Concomitant medication included acetylsalicylic acid (ASPIRIN 81) taken for an unspecified indication, start and stop date were not reported. The patient experienced right arm is aching on an unspecified date. Reporter stated that just got the second dose today and asked if she could take TYLENOL because her right arm is aching and the caller mentioned she took 81mg aspirin before she got the second dose The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: left hand went numb,Left wrist and hand had numbness before going to sleep; This is a spontaneous report from a contactable consumer. A 82-Year-old male patient received First dose of bnt162b2 (PFIZER-BIONTECH COVID19 VACCINE, Solution for injection), via an unspecified route of administration, administered in Arm Left on 15Feb2021 13:30 as single dose for covid-19 immunisation.  Medical history included diabetes, hypertension, Cured cancer, hayfever allergy. Concomitant medications included Metformin HCL, Vit D3, Vit B12. No other vaccine in four weeks. The patient reported on 16Feb2021 18:30, left hand went numb. Left wrist and hand had numbness before going to sleep on 18Feb2021. No numbness on 19th. Outcome of event was recovered on 19Feb2021.  Information of lot/batch number has been requested.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Arthralgia, Condition aggravated, Decreased appetite, Fatigue
Clinical narrative: fatigued; hypersensitivity to light, sound and smells; was unable to eat; feel off with stomach; some joint pain; increasing joint pain and muscle aches; headache; Did not sleep; excessive pain in all joints( pain on the bottom of my feet)/very sore arm; This is a spontaneous report from a contactable consumer. A 70-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EM 9809) via an unspecified route of administration on left arm on 02Feb2021 11:00 AM at single dose for covid-19 immunization. Medical history included Lyme disease (I had lyme disease within the last 3 years) and Allergy. Concomitant medications were not reported. The patient reported, on 09Feb2021 08:30 PM, day after injection she had very sore arm, Wednesday, begun to feel off with stomach and some joint pain. On Thursday, she had increasing joint pain and muscle aches and a base of the skull headache and did not sleep at night. On Friday, it was full blown excessive pain in all joints (pain on the bottom of my feet) and was unable to eat, tried to stay hydrated and slept for one hour at night. On Saturday, hypersensitivity to light, sound and smells, evening all symptoms started to go away and on Sunday, patient was recovering but still fatigued. The patient did not receive any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The outcome of the event fatigue was recovering, and rest of the events was recovered.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hyperaesthesia, Insomnia, Pain in extremity
Clinical narrative: fatigued; hypersensitivity to light, sound and smells; was unable to eat; feel off with stomach; some joint pain; increasing joint pain and muscle aches; headache; Did not sleep; excessive pain in all joints( pain on the bottom of my feet)/very sore arm; This is a spontaneous report from a contactable consumer. A 70-year-old non-pregnant female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EM 9809) via an unspecified route of administration on left arm on 02Feb2021 11:00 AM at single dose for covid-19 immunization. Medical history included Lyme disease (I had lyme disease within the last 3 years) and Allergy. Concomitant medications were not reported. The patient reported, on 09Feb2021 08:30 PM, day after injection she had very sore arm, Wednesday, begun to feel off with stomach and some joint pain. On Thursday, she had increasing joint pain and muscle aches and a base of the skull headache and did not sleep at night. On Friday, it was full blown excessive pain in all joints (pain on the bottom of my feet) and was unable to eat, tried to stay hydrated and slept for one hour at night. On Saturday, hypersensitivity to light, sound and smells, evening all symptoms started to go away and on Sunday, patient was recovering but still fatigued. The patient did not receive any treatment for the event. Prior to vaccination, the patient was not diagnosed with COVID-19; Since the vaccination, the patient not been tested for COVID-19. The outcome of the event fatigue was recovering, and rest of the events was recovered.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fibrin D dimer, Fibrin D dimer increased, Heart rate, Heart rate increased
Clinical narrative: high D-dimer test result (485); rapid heart rate; This is a spontaneous report from a contactable consumer (patient). A 78-years-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: unknown) via unspecified route of administration on 11Feb2021 08:30 AM in left arm as single dose for COVID-19 immunization. The patient's medical history was not reported. There were no known allergies. Concomitant medication included (other medications in two weeks) lisinopril, simvastatin, fluticasone propionate, salmeterol xinafoate (ADVAIR), ascorbic acid, betacarotene, biotin, calcium, chromium, colecalciferol, copper, folic acid, iodine, iron, lycopene, magnesium, manganese, nicotinamide, pantothenic acid, phosphorus, phytomenadione, potassium, pyridoxine hydrochloride, retinol, riboflavin, selenium, vitamin b1 nos, vitamin b12 nos, vitamin e nos, xantofyl, zinc (CENTRUM SILVER). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any COVID prior vaccination. Since the vaccination the patient was not tested for COVID-19. The patient experienced rapid heart rate on 14Feb2021, high D-dimer test result (485) on 15Feb2021 at 7.00 PM. The patient did not receive any treatment for the events. The AE resulted in doctor or other healthcare professional office/clinic visit. The outcome of the events was recovered on an unknown date in 2021.  Information on the lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, SARS-CoV-2 test
Clinical narrative: Shingles; This is a spontaneous report from a non-contactable pharmacist.   A 35-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 2 via an unspecified route of administration, administered in Arm Left on 20Jan2021 11:00 (Batch/Lot number was not reported) as SINGLE DOSE for covid-19 immunisation.  The patient's medical history and concomitant medications were not reported. The patient received first dose of BNT162B2 on 27Jan2021 at 35 years old for COVID-19 immunisation. (Product=COVID 19, brand= Pfizer, lot unknown= False, Administration date: 27Jan2021, administration time: 11:00 AM, vaccine location=Left arm, Dose number=1). On 09Feb2021, the patient experienced shingles. The patient underwent lab tests and procedures which included sars-cov-2 test: negative on 10Feb2021. Therapeutic measures were taken as a result of shingles. The outcome of the event was recovering.   No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: gotten rash on chest and back; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 69-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: solution for injection, Batch/Lot Number: EL3248 and expiration date: Unspecified), via an unspecified route of administration, administered in Arm Left on 11Feb2021 16:45 as SINGLE DOSE for covid-19 immunisation. Facility where most recent COVID-19 vaccine was administered was other. Medical history included pancreatic neuroendocrine tumour, benign prostatic hyperplasia. Concomitant medications received with 2 weeks of vaccination included tadalafil (TADALAFIL); tamsulosin (TAMSULOSIN); terbinafine (TERBINAFINE); ascorbic acid, ergocalciferol, folic acid, nicotinamide, panthenol, retinol, riboflavin, thiamine hydrochloride (MULTIVITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;FOLIC ACID;NICOTINAMIDE;PANTHENOL;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]) taken for an unspecified indication, start and stop date were not reported. The patient did not receive any other vaccine within 4 weeks prior to the COVID vaccine. Reportedly, patient was not diagnosed with COVID-19 prior to vaccination. Patient had not been tested for COVID-19 since the vaccination. On 12Feb2021 the patient experienced rash on chest and back. Reportedly, patient had received 1st dose of covid vaccine week and half ago. After vaccine had gotten rash on chest and back. Patient wanted to know if it will be safe to get 2nd dose of vaccine. No treatment was received for the adverse event. The outcome of event was not recovered/not resolved on an unspecified date.  Follow-up attempts are completed. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain, Vaccination site swelling
Clinical narrative: Injection site pain; Injection site swelling; Tiredness; This is a spontaneous report from a contactable consumer (Patient herself). A 74-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection and Lot Number: EL3302) via an unspecified route of administration in Arm Left on 11Feb2021 at 14:30 as single dose for COVID-19 immunization. Medical history included Obese and arthritis. Concomitant medications included ergocalciferol (VITAMIN D). On 11Feb2021 at 15:30 the patient experienced injection site pain, injection site swelling and tiredness. The seriousness of the events was reported as non-serious. The outcome of the event was recovered on an unspecified date in 2021.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: Just a little woozy 5 minutes after the vaccine. Took another 5 minutes to pass; 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, Solution for injection, lot number: EL8982) via unknown route of administration on 23Feb2021 11:45 AM as single dose in left arm for COVID-19 immunization at Hospital. Medical history included known allergies to Wasps. Concomitant medications were not reported. Patient was not pregnant at the time of vaccination. No covid prior vaccination. No other vaccine in four weeks. The patient experienced little woozy 5 minutes after the vaccine on 23Feb2021 11:50 AM. Took another 5 minutes to pass. No treatment to adverse event. No covid tested post vaccination. Outcome of event was recovered on 23Feb2021.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: red swollen rash on right side of face and ear; red swollen rash on right side of face and ear; This is a spontaneous report from a contactable consumer (patient). A 68-years-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number: EL9267), via an unspecified route of administration on 17Feb2021 at 11:00 (at the age of 68-years) as 1ST DOSE, SINGLE in Arm Left for covid-19 immunization. Medical history included Shrimp allergy. The patient was diagnosed with covid-19 prior to vaccination. Patient did not receive other vaccine within 4 weeks of vaccination. The patient received unspecified other medications within 2 weeks of vaccination. On 18Feb2021 at 07:00 AM, the patient experienced red swollen rash on right side of face and ear. The patient received treatment with fluocinolone Acet 0.01% cream 15gm. The events resulted in doctor or other healthcare professional office/clinic visit. The patient was not diagnosed with covid-19 post vaccination. The outcome of events was not recovered.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: shingles; This is a spontaneous report from a contactable physician from a Pfizer-sponsored program, COVAX US Support. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The physician stated that the patient contracted shingles after first covax vaccine. The patient has second dose scheduled for 20Feb2021; physician advised patient not to get second covax vaccine. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Herpetiform (zoster) eruption localized to L upper arm at site of previous Shingrix inoculation ~ 2 years ago; This is a spontaneous report from a contactable physician (patient). A 67-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 16Feb2021 10:00 (batch/lot number and expiration date were not reported) at the age of 67 years old, as single dose for COVID-19 immunisation. The patient's medical history was not reported. Concomitant medications included losartan; amlodipine; acetaminophen; and omeprazole; all taken for an unspecified indication, start and stop date were not reported. The patient previously took amoxicillin and experienced allergies. Historical vaccination included Shingrix given 2 years ago. No other vaccines received in four weeks. On 18Feb2021 08:00, the patient experienced herpetiform (zoster) eruption localized to L (left) upper arm at site of previous Shingrix inoculation 2 years ago. No treatment was given for the event. The patient was recovering from the event. The patient was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 post vaccination.   Information on the lot/batch number has been requested.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Dizziness, Fatigue, Headache, Myalgia
Clinical narrative: Severe and extended dizziness for 5 days.; Headache and very tired so sleepy can hardly keep eyes open; Headache and very tired so sleepy can hardly keep eyes open; Headache and very tired so sleepy can hardly keep eyes open; Muscle pain around abdomen; ran fever of 102.5 for 12 hours post injection with rigors; This is a spontaneous report from a contactable nurse (patient). A 65-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200 and expiration date was not reported), via an unspecified route of administration, in left arm on 20Feb2021 at 14:30 as SINGLE DOSE for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9269 and expiration date was not reported), via an unspecified route of administration, on 03Feb2021 at 17:00, as SINGLE DOSE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. Since the vaccination, has the patient not been tested for COVID-19. The patient was allergic to medications, food, or other products. The patient medical history included autoimmune disease iritis-right eye for which she was hospitalized for 2 days. Concomitant medications were not reported. On 21Feb2021, patient experienced severe and extended dizziness for 5 days. Headache and very tired so sleepy can hardly keep eyes open. Muscle pain around abdomen, generalized, ran fever of 102.5 for 12 hours post injection with rigors. The outcome of all events was reported as not recovered.  No follow-up attempts are possible. No further information was provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Somnolence
Clinical narrative: Severe and extended dizziness for 5 days.; Headache and very tired so sleepy can hardly keep eyes open; Headache and very tired so sleepy can hardly keep eyes open; Headache and very tired so sleepy can hardly keep eyes open; Muscle pain around abdomen; ran fever of 102.5 for 12 hours post injection with rigors; This is a spontaneous report from a contactable nurse (patient). A 65-years-old non-pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EN6200 and expiration date was not reported), via an unspecified route of administration, in left arm on 20Feb2021 at 14:30 as SINGLE DOSE for COVID-19 immunization. The patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9269 and expiration date was not reported), via an unspecified route of administration, on 03Feb2021 at 17:00, as SINGLE DOSE for COVID-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and medications within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior vaccination. Since the vaccination, has the patient not been tested for COVID-19. The patient was allergic to medications, food, or other products. The patient medical history included autoimmune disease iritis-right eye for which she was hospitalized for 2 days. Concomitant medications were not reported. On 21Feb2021, patient experienced severe and extended dizziness for 5 days. Headache and very tired so sleepy can hardly keep eyes open. Muscle pain around abdomen, generalized, ran fever of 102.5 for 12 hours post injection with rigors. The outcome of all events was reported as not recovered.  No follow-up attempts are possible. No further information was provided.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: headache; sweats; Chills, so bad that my teeth were rattling; fever; muscle aches; exhaustion; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration, administered in left arm on 10Feb2021 02:15 PM (Batch/Lot number was not reported) as single dose for covid-19 immunization. Patient was non-pregnant at the time of vaccination. Medical history included neuropathy and diabetes. The patient's concomitant medications was not reported. On 11Feb2021 patient experienced chills, fever, headache, muscle aches, sweats and exhaustion which lasted until Saturday 13Feb2021 and then patient was fine for several days but on the night of 17Feb at 8PM, again with the chills, so bad that patient's teeth were rattling, headache and sweats all this lasted until 3 AM then patient had aches and exhaustion for several days". The treatment was not received for the adverse events. Outcome of headache and sweats was recovered on an unspecified date and rest of the event was recovered on 13Feb2021.  No follow up attempts are needed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: headache; sweats; Chills, so bad that my teeth were rattling; fever; muscle aches; exhaustion; This is a spontaneous report from a contactable consumer (patient). A 77-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) dose 1 via an unspecified route of administration, administered in left arm on 10Feb2021 02:15 PM (Batch/Lot number was not reported) as single dose for covid-19 immunization. Patient was non-pregnant at the time of vaccination. Medical history included neuropathy and diabetes. The patient's concomitant medications was not reported. On 11Feb2021 patient experienced chills, fever, headache, muscle aches, sweats and exhaustion which lasted until Saturday 13Feb2021 and then patient was fine for several days but on the night of 17Feb at 8PM, again with the chills, so bad that patient's teeth were rattling, headache and sweats all this lasted until 3 AM then patient had aches and exhaustion for several days". The treatment was not received for the adverse events. Outcome of headache and sweats was recovered on an unspecified date and rest of the event was recovered on 13Feb2021.  No follow up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: Diahrea with watery stools at least 5 times a day even during urination.; This is a spontaneous report from a contactable consumer (patient). A 83-year-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: EN6201,) via an unspecified route of administration administered in left arm on 10Feb2021 12:30 am at single dose for COVID-19 immunisation. Medical history included sleep apnoea syndrome, Penicilin Allergy. The patient was not tested for covid prior vaccination and post vaccination. The patient experienced diarrhea with watery stools at least 5 times a day even during urination on 10Feb2021 21:00. The treatment was not received for the event. The outcome of the event was not recovered.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal distension, Diarrhoea, Fatigue, Headache, Muscular weakness
Clinical narrative: Stomach Bloating; Headache; All over body pain; Muscle Weakness; Fatigue/Tiredness; Diarrhea; This is a spontaneous report from a contactable consumer (patient).   A 60-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration, administered in left arm on 24Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient previously administered with first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) administration date on 01Feb2021 at 9:15 AM on left arm for COVID-19 immunization and Shingrix vaccine dose first dose administered on 16Nov2020 and second dose on 23Jan2021 both in in right arm. The patient had no known allergies or other medical history. The patient did not have covid prior to vaccination. Concomitant medication included loratadine, pseudoephedrine sulfate (CLARITIN-D), ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE), colecalciferol (50m D3) and apple cider vinegar (600m Apple Cider Vine). On an unspecified date in 2021 at 08:00 AM, the patient experienced headache (lasted 2 days), all over body pain, muscle weakness, fatigue/tiredness, stomach bloating and diarrhea. The patient did not receive treatment for the events. The patient did not test for covid post vaccination. The outcome of headache was resolved and for other events it was recovering.  Information about lot/batch number has been requested.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Stomach Bloating; Headache; All over body pain; Muscle Weakness; Fatigue/Tiredness; Diarrhea; This is a spontaneous report from a contactable consumer (patient).   A 60-years-old male patient received second dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine, solution for injection, Batch/Lot Number: Not reported), via an unspecified route of administration, administered in left arm on 24Feb2021 as SINGLE DOSE for covid-19 immunisation. The patient previously administered with first dose of bnt162b2 (Pfizer-Biontech Covid-19 Vaccine) administration date on 01Feb2021 at 9:15 AM on left arm for COVID-19 immunization and Shingrix vaccine dose first dose administered on 16Nov2020 and second dose on 23Jan2021 both in in right arm. The patient had no known allergies or other medical history. The patient did not have covid prior to vaccination. Concomitant medication included loratadine, pseudoephedrine sulfate (CLARITIN-D), ascorbic acid, herbal nos, levoglutamide, lysine, magnesium, manganese, retinol, riboflavin, selenium, tocopherol, zinc (AIRBORNE), colecalciferol (50m D3) and apple cider vinegar (600m Apple Cider Vine). On an unspecified date in 2021 at 08:00 AM, the patient experienced headache (lasted 2 days), all over body pain, muscle weakness, fatigue/tiredness, stomach bloating and diarrhea. The patient did not receive treatment for the events. The patient did not test for covid post vaccination. The outcome of headache was resolved and for other events it was recovering.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Urine abnormality, Urine odour abnormal
Clinical narrative: urine is cloudy and had an unusual smell; urine is cloudy and had an unusual smell; This is a spontaneous report from a contactable consumer (patient). A female patient of an unspecified age (reported as senior) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Lot number and expiration date was not provided), via an unspecified route of administration on 25Feb2021 as single dose for covid-19 immunisation. Medical history and concomitant medications were not provided. On 25Feb2021, at night, the urine was cloudy and had an unusual smell (happened twice at night). The outcome for the events was recovered on 26Feb2021 (reported as everything was back to normal).  No follow-up attempts are possible; Information about lot/batch number cannot be obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blood test, Fatigue, Hypoaesthesia, Myalgia
Clinical narrative: numbness/ Numbness on left side of the body; joint inflammation/Swollen joints; severe tiredness; Muscle pain; Swollen lungs; This is spontaneous report from a contactable consumer via a HCP.  A 44-years-old non pregnant female patient received first dose of BNT162B2 (solution for injection, Lot number: EL3301 expiry date: unknown) via an unspecified route of administration on 29DEC2020 01:30 PM, as a single dose for Covid-19 immunization at Nursing Home/Senior Living Facility. The patient Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 The patient has no history of allergies to medications, food, or other products. On 19Jan2021, the patient experienced swollen lungs. On an unknown date, she experienced numbness on left side of the body, swollen joints, muscle pain and severe tiredness. She received treatment with Medecina, for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event of swollen lungs was not recovered, while other events was unknown.  No follow-up attempts were needed. No further information was expected. Lot number obtained.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Pneumonitis
Clinical narrative: numbness/ Numbness on left side of the body; joint inflammation/Swollen joints; severe tiredness; Muscle pain; Swollen lungs; This is spontaneous report from a contactable consumer via a HCP.  A 44-years-old non pregnant female patient received first dose of BNT162B2 (solution for injection, Lot number: EL3301 expiry date: unknown) via an unspecified route of administration on 29DEC2020 01:30 PM, as a single dose for Covid-19 immunization at Nursing Home/Senior Living Facility. The patient Medical history and concomitant medications were not reported. Prior to the vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19 The patient has no history of allergies to medications, food, or other products. On 19Jan2021, the patient experienced swollen lungs. On an unknown date, she experienced numbness on left side of the body, swollen joints, muscle pain and severe tiredness. She received treatment with Medecina, for the event. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The outcome of the event of swollen lungs was not recovered, while other events was unknown.  No follow-up attempts were needed. No further information was expected. Lot number obtained.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: Breaking out - rash on back and sides,itching; Breaking out - rash on back and sides; This is a spontaneous report from a contactable consumer (patient) via a Pfizer Sponsored Program. A 67-year-old non-pregnant female patient (at the time of vaccination) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiration date were not reported), dose 1 via an unspecified route of administration, administered in arm left on 26Feb2021 at 15:30 as single dose for COVID-19 immunization. The patient history included penicillin allergies. The patient concomitant medications were not reported. The patient had penicillin allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient did not receive any other medications within 2 weeks of vaccination. On 26Feb2021 at 19:00, the patient experienced breaking out - rash on back and sides, itching. It was reported that she called the pharmacy where she received her first dose yesterday afternoon to report the side effects she experienced after taking the vaccine but was referred back to report. According to her, she experienced itching and rash on her back and side last night and she said that Benadryl took care of it this morning and the rash was gone. The outcome of the events was recovered in on an unspecified date.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Family member developed shingles a week after 2nd dose of Covid vaccine.; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the second dose of bnt162b2 (BNT162B2, Solution for injection), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as SINGLE DOSE for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient previously received the first dose of bnt162b2 (BNT162B2), on an unspecified date (Batch/Lot number was not reported) for COVID-19 immunization. The reporter stated that a family member developed shingles a week after 2nd dose of Covid vaccine. They are calling to see if this has been reported before. Outcome of the event was unknown.   Information on lot number/batch number has been requested.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Lip swelling, Pruritus, Throat irritation, Tongue pruritus
Clinical narrative: Swollen bottom lip; Red marks under skin/Tiny red spots under skin; Tiny red spots under skin, itchy but no hives; Itchy throat and tongue; Itchy throat and tongue; This is a spontaneous report from a contactable consumer (patient).  A non-pregnant 52-year-old female received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number: EL9266 and Expiration date was not reported), via an unknown route of administration in right arm on 28Feb2021 at 09:30, as a SINGLE DOSE for COVID-19 immunization. The patient was not diagnosed with COVID-19 prior vaccination. Since the vaccination, has the patient not been tested for COVID-19. The patient medical history included high risk asthma and the patient had allergies to erythromycin, amoxicillin and penicillin. The concomitant medication included pantoprazole (patient received within 2 weeks of vaccination). On 28Feb2021 at 10:45 (same day of vaccination), the patient reported tiny red spots under skin, itchy but no hives, swollen bottom lip, itchy throat and tongue. The outcome of the event tiny red spots under skin, itchy but no hives was recovering whereas, for other events was recovered in 2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Pain, Tremor
Clinical narrative: had severe body shakes as if subjected to freezing temperatures for approx. 2 hours from 03:00 AM to 05:00AM with body temperature at 98.5 degrees farenheit and shaking stopped at 05:00 and body temperature was 101.7 degrees farenheit. Throughout the day, body temperature ranged from 98.7 degrees farenheit to 101.9 degrees farenheit. There was some slight body aches as well. By 05/09/2021 side effects went away,\.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal pain, Diarrhoea, Nausea, Vomiting
Clinical narrative: nausea and vomiting Friday night.. diarrhea and stomach upset, bad right abdominal pain lasting through Monday morning (more than 72 hours later).  After the first dose, had GI problems too, but without nausea and the pain.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthritis, Blood test, Computerised tomogram, Dehydration, Headache
Clinical narrative: About three weeks after getting the J & J vaccine, I began getting headaches, mostly on the top of my head. They have lasted a month. Within a week I went to the ER and had a battery of tests; The only thing that showed up is that I was dehydrated after several hours of not drinking water. Normally, I drink about 64 oz. of water a day. The pain sometimes radiated to my neck. An x-ray showed arthritis. I have had occasional nausea.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Neck pain, Pain, X-ray abnormal
Clinical narrative: About three weeks after getting the J & J vaccine, I began getting headaches, mostly on the top of my head. They have lasted a month. Within a week I went to the ER and had a battery of tests; The only thing that showed up is that I was dehydrated after several hours of not drinking water. Normally, I drink about 64 oz. of water a day. The pain sometimes radiated to my neck. An x-ray showed arthritis. I have had occasional nausea.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blepharitis, Cellulitis, Ecchymosis, Face oedema, Facial pain
Clinical narrative: Dear Sir or Madam: Writing to you to please refer me to VAERS for possible CVST s/p dose 2 of Moderna I am a retired APRN and just reviewed your article HPI: 57 y/o female  (not obese, no hypothyroidism) H/O travel (February1-March 1 2021) with possible SARS Cov2 exposure; possible long COVID Big supporter of public health and COVID19 vaccine campaign with Moderna dose one 2/14/21 and dose 2 on 3/14/21 Mild to moderate sx after both doses Routine ophthalmology exam 4/8/21 Approximately 4/13/21 left sided facial pain, HA and swelling-self treated for blepharitis with warm compresses 4/15/21 returned to ophthalmologist: forceful lower lid compression applied and diagnosed with pre-septal cellulitis-Rxd Augmentin 875 and steroid dose pack-on return to home experienced severe projectile vomiting x2 and awakened with massive facial edema and ecchymosis-petechial hemorrhages-terrible sinus pain Went back to ophthalmology-they said I had a chalezion and  black eye-referred back to PCP for r/o temporal arteritis. ESR and CRP neg Symptoms progressed to severe headache in left temporal lobe since 4/15/21-severe nausea, changes in speech, problems with word finding photophobia, global malaise, fatigue (seems like migraine) Went to see PCP 5/6/21 and transported via ambulance to ER for severe HA; HTN; neuro deficits, r/o stroke  CBC CMP Etc wnl with CT of Head showing no stroke or aneurysm. Physician did state there may have been Micro thrombi not detected on CT. Neurology consult with plan to treat intractable HA and rxd Zofran and Sumatriptan -I do not recall anyone asking me about COVID19 vaccine timing or side effects. No PL4   As an APRN I would say I have never had migraines-now experience left sided head pain radiating from temporal lobe to jaw; this waxes and wanes; nausea; overall rapid onset of persistent speech deficit and organizational problems also noted by spouse (since dose 2 Moderna)-symptoms poorly controlled with migraine medication  I think this needs further investigation as potential vaccine side effect
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Hypertension, Malaise, Nausea, Petechiae
Clinical narrative: Dear Sir or Madam: Writing to you to please refer me to VAERS for possible CVST s/p dose 2 of Moderna I am a retired APRN and just reviewed your article HPI: 57 y/o female  (not obese, no hypothyroidism) H/O travel (February1-March 1 2021) with possible SARS Cov2 exposure; possible long COVID Big supporter of public health and COVID19 vaccine campaign with Moderna dose one 2/14/21 and dose 2 on 3/14/21 Mild to moderate sx after both doses Routine ophthalmology exam 4/8/21 Approximately 4/13/21 left sided facial pain, HA and swelling-self treated for blepharitis with warm compresses 4/15/21 returned to ophthalmologist: forceful lower lid compression applied and diagnosed with pre-septal cellulitis-Rxd Augmentin 875 and steroid dose pack-on return to home experienced severe projectile vomiting x2 and awakened with massive facial edema and ecchymosis-petechial hemorrhages-terrible sinus pain Went back to ophthalmology-they said I had a chalezion and  black eye-referred back to PCP for r/o temporal arteritis. ESR and CRP neg Symptoms progressed to severe headache in left temporal lobe since 4/15/21-severe nausea, changes in speech, problems with word finding photophobia, global malaise, fatigue (seems like migraine) Went to see PCP 5/6/21 and transported via ambulance to ER for severe HA; HTN; neuro deficits, r/o stroke  CBC CMP Etc wnl with CT of Head showing no stroke or aneurysm. Physician did state there may have been Micro thrombi not detected on CT. Neurology consult with plan to treat intractable HA and rxd Zofran and Sumatriptan -I do not recall anyone asking me about COVID19 vaccine timing or side effects. No PL4   As an APRN I would say I have never had migraines-now experience left sided head pain radiating from temporal lobe to jaw; this waxes and wanes; nausea; overall rapid onset of persistent speech deficit and organizational problems also noted by spouse (since dose 2 Moderna)-symptoms poorly controlled with migraine medication  I think this needs further investigation as potential vaccine side effect
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Sinus pain, Speech disorder, Swelling, Vomiting
Clinical narrative: Dear Sir or Madam: Writing to you to please refer me to VAERS for possible CVST s/p dose 2 of Moderna I am a retired APRN and just reviewed your article HPI: 57 y/o female  (not obese, no hypothyroidism) H/O travel (February1-March 1 2021) with possible SARS Cov2 exposure; possible long COVID Big supporter of public health and COVID19 vaccine campaign with Moderna dose one 2/14/21 and dose 2 on 3/14/21 Mild to moderate sx after both doses Routine ophthalmology exam 4/8/21 Approximately 4/13/21 left sided facial pain, HA and swelling-self treated for blepharitis with warm compresses 4/15/21 returned to ophthalmologist: forceful lower lid compression applied and diagnosed with pre-septal cellulitis-Rxd Augmentin 875 and steroid dose pack-on return to home experienced severe projectile vomiting x2 and awakened with massive facial edema and ecchymosis-petechial hemorrhages-terrible sinus pain Went back to ophthalmology-they said I had a chalezion and  black eye-referred back to PCP for r/o temporal arteritis. ESR and CRP neg Symptoms progressed to severe headache in left temporal lobe since 4/15/21-severe nausea, changes in speech, problems with word finding photophobia, global malaise, fatigue (seems like migraine) Went to see PCP 5/6/21 and transported via ambulance to ER for severe HA; HTN; neuro deficits, r/o stroke  CBC CMP Etc wnl with CT of Head showing no stroke or aneurysm. Physician did state there may have been Micro thrombi not detected on CT. Neurology consult with plan to treat intractable HA and rxd Zofran and Sumatriptan -I do not recall anyone asking me about COVID19 vaccine timing or side effects. No PL4   As an APRN I would say I have never had migraines-now experience left sided head pain radiating from temporal lobe to jaw; this waxes and wanes; nausea; overall rapid onset of persistent speech deficit and organizational problems also noted by spouse (since dose 2 Moderna)-symptoms poorly controlled with migraine medication  I think this needs further investigation as potential vaccine side effect
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: 101.2 FEVER,  Tylenol taken, fever was gone in about 24 hours
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever; Chills; Fatigue; This is a spontaneous report from a contactable consumer.   A 78-years-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, administered in Arm Left on an unspecified date (Batch/Lot Number: EE9231) single dose for covid-19 immunisation.  Medical history included hypertension from an unknown date and unknown if ongoing, diabetes mellitus from an unknown date and unknown if ongoing, colitis ulcerative from an unknown date and unknown if ongoing. Concomitant medication included amlodipine (AMLODIPINE) taken for an unspecified indication, start and stop date were not reported; metformin (METFORMIN) taken for an unspecified indication, start and stop date were not reported; losartan (LOSARTAN) taken for an unspecified indication, start and stop date were not reported; hydrochlorothiazide (HYDROCHLOROTHIAZIDE) taken for an unspecified indication, start and stop date were not reported; mesalazine (LIALDA) taken for colitis ulcerative, start and stop date were not reported; calcium (CALCIUM) taken for an unspecified indication, start and stop date were not reported.   The patient experienced fever (non-serious) on an unspecified date with outcome of unknown, chills (non-serious) on an unspecified date with outcome of unknown, fatigue (non-serious) on an unspecified date with outcome of unknown.   No follow up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Pyrexia
Clinical narrative: shingles on the left chest, side and back; Low grade fever; This is a spontaneous report from a contactable healthcare professional. A 58-year-old female patient received of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular, administered in left arm on 26Feb2021 08:00 (at the age of 58 years old) (Lot Number: EL9267) at 2nd dose, single for covid-19 immunization. Medical history included known allergies to kiwi, penicillin and sulfa drugs; all from an unknown date and unknown if ongoing. The patient did not have covid prior vaccination. The patient was not pregnant at time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (Lot number: EL9269), intramuscular in left arm on 05Feb2021 08:00 AM for COVID-19 immunization. The patient experienced low grade fever on 28Feb2021 15:00 and shingles on the left chest, side and back on 01Mar2021 15:00. Patient had low grade fever 30 hours later that lasted for 14 hours, 24 hours later, shingles on the left chest, side and back. It was reported that this was definitely caused by the vaccine. The patient has not been tested for covid post vaccination. The events resulted in Physician Office Visit. Therapeutic measures were taken as a result of low grade fever and shingles on the left chest, side and back included Famciclovir 500 mg. tid. The outcome of the events not recovered.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Herpes zoster, X-ray
Clinical narrative: rash that was burning/diagnosed as Shingles; This is a spontaneous report from a contactable healthcare professional (patient). A non-pregnant 74-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in right arm on 23Feb2021 at 08:15 AM (at the age of 74 years old) (Lot Number: EN6200, unknown expiration) as a single dose for COVID-19 immunisation.  Medical history included high blood pressure and diabetes. The patient has unspecified concomitant medication. The patient also received first dose of BNT162B2 on 30Jan2021 at 09:15 AM (lot number: EL9264, unknown expiration) in right arm for COVID-19 immunisation. On 24Feb2021 at 08:00 AM, the patient experienced rash that was burning which was diagnosed as shingles. The patient had blood work and x-ray done with unknown results and was given prescriptions. The event resulted in doctor or other healthcare professional office/clinic and emergency room/department or urgent care visit. The patient did not receive other vaccine in four weeks.  The patient has no COVID prior to vaccination and was not tested for COVID post vaccination. The patient had not yet recovered from the event.  No follow-up attempts are possible. No further information is expected.