chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Throat irritation
Clinical narrative: sore arm; like a cold coming on; congestion like a head cold and nose running and my throat is kind of flamed up a little bit; little runny nose; drainage in throat; Little aches and chills; It is hard for me to stay warm; Little aches and chills; It is hard for me to stay warm; fatigued, little tired; flu symptoms; little headache; itchy throat; This is a spontaneous report from a contactable consumer (patient, reported for self). A 75-year-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number and Expiry date: unknown), via an unspecified route of administration, administered in arm right on 26Feb2021 12:30 (at the age of 75-year-old) as dose 1, single for COVID-19 immunisation at Pharmacy. Medical history included ongoing prostate problems, prostate cancer, allergic reaction to penicillin (He had an allergic reaction to penicillin. He had something they gave him penicillin for when he was around 14 years old. It made him pass out). Concomitant medications included dutasteride (AVODART) oral 0.5 mg gel cap one a day: morniflumate (FLOMAX) oral 0.4 mg capsule one a day both taken for prostate infection from unspecified date(s) and ongoing. No history of any previous immunization with the Pfizer vaccine considered as suspect. No additional vaccines administered on same date of the Pfizer suspect. No vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine. No Adverse events following prior vaccinations. On 27Feb2021 the patient experienced congestion like a head cold and nose was running, and his throat was kind of flamed up a little bit. Little aches and chills. It was hard for him to stay warm, little tired. Patient was having flu symptoms. He got a little headache, little runny nose, and little symptoms in his glands in his throat, he clarified his glands did not feel swollen, he just had throat drainage. He had a sore arm for a day maybe a day and a half (unspecified date). He was also fatigued. His throat it itched (itchy throat), like a cold coming on or like the flu. Adverse event did not require a visit to Emergency Room/Physician Office. No investigation assessment. Therapeutic measures were taken as a result of the event(headache). Patient has been taking over the counter medicine and wants to know if its ok. He's been taking daytime and nighttime Nyquil and he took Aleve for his headache. Patient has been taking the recommended dosage for Nyquil because it comes with that little cup. He's taken Aleve when his headache gets kind of bad, he takes 1 pill, they are 220 milligrams. The events were non-serious. The outcome of the event sore arm was unknown and that of other events was reported as not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Vomiting
Clinical narrative: extreme nausea; vomiting; headache; general body aches; This is a spontaneous report from a contactable consumer (patient). A 26-years-old non pregnant female patient received BNT162B2 (PFIZER BIONTECH COVID-19 vaccine, Formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route, administered in Left Arm on 02Mar2021 at 10:00 (age at vaccination 26-year-old, non-pregnant) as dose 1, single for covid-19 immunisation. Medical history included drug hypersensitivity allergy of sulpha drugs, food allergy shellfish allergy. Concomitant medication(s) included etonogestrel (NEXPLANON). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not diagnosed with COVID-19 post vaccination. The patient previously took iodine and experienced drug hypersensitivity, pepto bismol [bismuth subsalicylate; calcium carbonate] and experienced drug hypersensitivity. Workplace facility type was clinic. Within 1.5 hours of receiving the vaccine on 02Mar2021 at 11:30 the patient experienced extreme nausea, vomiting, headache and general body aches. This lasted through the following 24 hours.  No treatment was received. The outcome of the events were recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Got my 1st shot arm sore not much; a little tired but not bad; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, Batch/ Lot number: Not available) via an unspecified route of administration on unspecified date as dose 1, single for COVID-19 immunization. The patients medical history and concomitant medications were not reported. On unspecified date the patient got her 1st shot arm sore not much, a little tired but not bad. Get her 2nd one on the 14th. The patient is scheduled to get her second dose tomorrow 06May2021 and unable to attend her second dose appointment due to power outage in her location. she received her second dose last 14Apr2021.Read FAQ's second dose and refer to the facility to reschedule her appointment. The outcome of the events was unknown.  Follow-up (05May2021): This is a spontaneous report from an Agency. A contactable female consumer (patient) reported.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vaccination site erythema, Vaccination site mass, Vaccination site swelling, Vaccination site warmth
Clinical narrative: dizzy; her arm where she got the injection, was a little red about a half inch and it has continued to get bigger; her arm where she got the injection, was a little red about a half inch and it has continued to get bigger; it is swollen, red and holding heat; it is swollen, red and holding heat; This is a spontaneous report from a contactable consumer.  A 76-year-old female patient 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 Mar2021 as dose 1, single for COVID-19 immunization. Medical history and concomitant medications were not reported. On Mar2021 the patient experienced dizzy, her arm where she got the injection, was a little red about a half inch and it has continued to get bigger, her arm where she got the injection, was a little red about a half inch and it has continued to get bigger, it is swollen, red and holding heat, it is swollen, red and holding heat.  The outcome of the events were unknown.  No follow up attempts are possible; Information about Lot/batch number cannot be obtained.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain, Lymph node pain, Pyrexia
Clinical narrative: Hours after the injection, soreness at the spot of the injection that has subsuded. Sore lymph nodes beginning on the side of the injection around 3pm the next day. 100.3 fever two nights after the injection.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pharyngeal swelling, Speech disorder
Clinical narrative: Throat started swelling and could not hardly talk; Throat started swelling and could not hardly talk; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 58-year-old non pregnant female patient received second dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: ER8730) via an unspecified route of administration, administered in right arm on 29Mar2021 (at the age of 58-year-old) at single dose for COVID-19 immunisation. Patient was not pregnant at the time of vaccination. The patient's medical history included chronic obstructive pulmonary disease from an unknown date and unknown if ongoing and Penicillin allergy. The patient's concomitant medications were not reported. The patient's historical vaccine included first dose of bnt162b2 (BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection, Batch/Lot Number: EN6199) via an unspecified route of administration, administered in left arm on 01Mar2021 at 08:15 AM (at the age of 58-year-old) at single dose for COVID-19 immunisation. Facility where the most recent COVID-19 vaccine was administered was reported as other and the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, patient was not diagnosed with COVID-19 and since the vaccination, patient had not been tested for COVID-19. Vaccine Facility information was available at the time of report. On 29Mar2021 at 08:45, the patient experienced throat started swelling and could not hardly talk. The patient did not receive any treatment for the events. The adverse event did not result in anything. The clinical outcome of events was reported as recovered with sequelae (lasting effects).  No follow-up attempts are needed. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2  vaccination's  3 weeks apart
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Nausea, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Fever of 101, nausea, asthma attack (probably not related, but I don?t want to leave it out just in case). All symptoms began approximately 17 hours post-injection
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Eye swelling, Lip swelling, Pharyngeal swelling, Type IV hypersensitivity reaction
Clinical narrative: Delayed anaphylaxis: swelling of eyes, lips, throat
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pain
Clinical narrative: Extreme pain in Right Knee; Severe body aches; chills; This is a spontaneous report from a contactable consumer (patient). A 70-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN 6207) via an unspecified route of administration in the right arm on 11Mar2021 14:45 (at the age of 70-years-old) as DOSE 1, SINGLE for COVID-19 immunization. The patient's medical history included fibromyalgia and urinary tract infection (UTI) from an unknown date and unknown if ongoing. Concomitant medications included mirabegron (MYRBETRIQ) for UTI from 02Mar2021 to 15Mar2021 and nitrofurantoin (MACROBID) for UTI from 06Mar2021 to 12Mar2021. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID-19 vaccine. On 12Mar2021 20:00, the patient experienced severe body aches and chills which were lasted approximately 24 hours and stopped. On 13Mar2021 at 17:00, she had extreme pain in right knee, she could not put any weight on it and had severe pain for 10 days. Her pain slowly went away after 2 weeks. The events resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of events included chiropractic muscle massage and steam. The clinical outcome of the events chills and severe body aches was recovered on an unspecified date in Mar2021, while the outcome of the event extreme pain in right knee was recovered on an unspecified date in 2021.   No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Body temperature, Chills, Diarrhoea, Muscle spasms
Clinical narrative: intense stomach pain; aches; chills; fever or 100.6; extreme nausea; vomiting; Diarrhea; severe body cramping, small seizures; severe body cramping, small seizures; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 08Apr2021 at 09:45 (at the age of 41 years old) (Batch/Lot Number: Er8729) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Ibs-d (irritable bowel syndrome) and PCOS. Concomitant medication(s) included celecoxib (CELEXA [CELECOXIB]); montelukast sodium (SINGULAIR); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and omeprazole (PRILOSEC [OMEPRAZOLE]), all taken for an unspecified indication, start and stop dates were not reported. Known allergies included Darvocet, Vicodin, tramadol. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 18Mar2021 at 16:30 (at the age of 41 years old) (Batch/Lot Number: Er2613) as DOSE 1, SINGLE for covid-19 immunisation and experienced aches and nausea. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Patient was not pregnant at the time of vaccination. With the second shot, on 09Apr2021 at 22:00, patient had aches, chills, a fever or 100.6, extreme nausea/vomiting and diarrhea. After 6 hours of vomiting and diarrhea she had to go to the ER to be hydrated. On 10Apr2021, at 4:00, she had intense stomach pain that also required medical review. The intense vomiting and diarrhea came and went within the first 48 hours. The fever broke after 50 hours of the shot. breathing, severe body cramping, small seizures (unspecified date in Apr2021). Events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of all the events (IV hydration, anti nausea medicine and anti diarrh). The patient underwent lab tests and procedures which included body temperature: 100.6 on 09Apr2021. The outcome of intense vomiting and diarrhea was recovered on 11Apr2021 and all other events were recovering.  No follow-up attempts are needed. No further information is expected.
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Pyrexia, Seizure, Vomiting
Clinical narrative: intense stomach pain; aches; chills; fever or 100.6; extreme nausea; vomiting; Diarrhea; severe body cramping, small seizures; severe body cramping, small seizures; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 41-years-old non-pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration, administered in left arm on 08Apr2021 at 09:45 (at the age of 41 years old) (Batch/Lot Number: Er8729) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Ibs-d (irritable bowel syndrome) and PCOS. Concomitant medication(s) included celecoxib (CELEXA [CELECOXIB]); montelukast sodium (SINGULAIR); cetirizine hydrochloride (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) and omeprazole (PRILOSEC [OMEPRAZOLE]), all taken for an unspecified indication, start and stop dates were not reported. Known allergies included Darvocet, Vicodin, tramadol. Historical vaccine included bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection), dose 1 via an unspecified route of administration, administered in left arm on 18Mar2021 at 16:30 (at the age of 41 years old) (Batch/Lot Number: Er2613) as DOSE 1, SINGLE for covid-19 immunisation and experienced aches and nausea. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination, the patient had not been tested for COVID-19. Patient was not pregnant at the time of vaccination. With the second shot, on 09Apr2021 at 22:00, patient had aches, chills, a fever or 100.6, extreme nausea/vomiting and diarrhea. After 6 hours of vomiting and diarrhea she had to go to the ER to be hydrated. On 10Apr2021, at 4:00, she had intense stomach pain that also required medical review. The intense vomiting and diarrhea came and went within the first 48 hours. The fever broke after 50 hours of the shot. breathing, severe body cramping, small seizures (unspecified date in Apr2021). Events resulted in Emergency room/department or urgent care. Therapeutic measures were taken as a result of all the events (IV hydration, anti nausea medicine and anti diarrh). The patient underwent lab tests and procedures which included body temperature: 100.6 on 09Apr2021. The outcome of intense vomiting and diarrhea was recovered on 11Apr2021 and all other events were recovering.  No follow-up attempts are needed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, Fatigue, Headache
Clinical narrative: Covid infection; Covid infection; Fatigue; Really bad headache; Shakes; Fever of 101 F.; This is a spontaneous report from a contactable consumer.   A 66-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 05Apr2021 at 07:00 AM, as 2nd single dose, for COVI-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had received the 1st dose of BNt162b2 on an unspecified date and had experienced a short period of dizziness (less than 30 seconds). After getting the 2nd dose, the patient experienced no symptoms for about 20 hours. But then, 20 hours later, which was around 02:00 AM on 06Apr2021, the patient woke up with shakes and fever of 101 Fahrenheit. The patient took 3 Advil to fall asleep, then woke up at about 05:00 AM with a really bad headache that lasted about 24 hours. On 07Apr2021, the patient woke up at 02:00 AM with no headache or any other symptoms except from some fatigue which was still present as of 08Apr2021. The patient was the diagnosed with a breakthrough Covid infection on 10Oct2021. The patient recovered from shakes, fever, and headache on 07Apr2021, while the outcome of the remaining events at the time of the last reporting on 18Oct2021 was not specified.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021401210 Same reporter/drug/patient, different dose/event
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Covid infection; Covid infection; Fatigue; Really bad headache; Shakes; Fever of 101 F.; This is a spontaneous report from a contactable consumer.   A 66-year-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration, on 05Apr2021 at 07:00 AM, as 2nd single dose, for COVI-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient had received the 1st dose of BNt162b2 on an unspecified date and had experienced a short period of dizziness (less than 30 seconds). After getting the 2nd dose, the patient experienced no symptoms for about 20 hours. But then, 20 hours later, which was around 02:00 AM on 06Apr2021, the patient woke up with shakes and fever of 101 Fahrenheit. The patient took 3 Advil to fall asleep, then woke up at about 05:00 AM with a really bad headache that lasted about 24 hours. On 07Apr2021, the patient woke up at 02:00 AM with no headache or any other symptoms except from some fatigue which was still present as of 08Apr2021. The patient was the diagnosed with a breakthrough Covid infection on 10Oct2021. The patient recovered from shakes, fever, and headache on 07Apr2021, while the outcome of the remaining events at the time of the last reporting on 18Oct2021 was not specified.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021401210 Same reporter/drug/patient, different dose/event
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, SARS-CoV-2 test
Clinical narrative: Loss of smell; Loss of taste; This is a spontaneous report from a contactable consumer or other non hcp. This consumer reported for female patient. A 66-years-old non pregnant elderly female patient received (not pregnant at the time of vaccination) bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 2 via an unspecified route of administration, administered in arm right on 27Mar2021 16:30 (Batch/Lot number was not reported) (at the age of 66-years-old) as dose 2, single for covid-19 immunisation. Medical history included non-small cell lung cancer from an unknown date and unknown if ongoing, emphysema from an unknown date and unknown if ongoing, hypertension from an unknown date and unknown if ongoing, hypothyroidism from an unknown date and unknown if ongoing. The patient not had allergies to medication, food, or other products. The patient received medication within 2 weeks of vaccination. The patient had previously received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA vaccine, Solution for injection), dose 1 via an unspecified route of administration, on an unknown date (Batch/Lot Number: unknown) as dose 1, single for covid-19 immunization. The patient did not receive any other vaccines within 4 weeks prior to the covid 19 vaccine. The patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. On 30Mar2021 07:30 AM, the patient experienced Loss of smell and Loss of taste 4 days later. The patient not received treatment for the event. The patient underwent lab tests and procedures which included nasal swab (sars-cov-2 test): negative on 04Apr2021. The outcome of the events was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face
Clinical narrative: "my face got swollen for days"; This is a spontaneous report from a contactable consumer (patient). A 34-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 03Apr2021 at 11:00 (at the age of 34-year-old) (Lot Number: ER8134) as dose 1, single for covid-19 immunisation. Medical history included arrhythmia. Concomitant medications included iron, magnesium, prenatal vitamins and probiotics medications in two weeks. The patient previously experienced known allergies for penicillin, cephalopods, shellfish, pollens and Fruit allergy (Allergy to apple). The patient reported event described as my face got swollen for days from 03Apr2021 at 11:30. It was reported that within 30 minutes (including 15minutes of wait after vaccination) my face got swollen for days. Allergic to many things. However my husband who IS allergic to nothing got his face swollen too after vaccination. Patient did not receive any other vaccines within 4 weeks to the COVID vaccine. The patient was not tested positive for covid 19 prior to vaccination and had not been tested post vaccination. Patient did not receive treatment post onset of event. Outcome of the event was recovered with sequelae.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021407191 same drug/AE, different patient
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Dizziness, Nausea, Pyrexia
Clinical narrative: dizziness; chills; fever; nausea; diarrhea; This is a spontaneous report from a contactable Consumer (patient). A 31-year-old non pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 14Apr2021 16:45 as dose 2, single for COVID-19 immunization (Age at Vaccination was 31years). The patient medical history included depression from an unknown date and unknown if ongoing. There were no concomitant medications. It was reported that, the patient did not receive any other vaccine in four weeks and any other medications in two weeks prior COVID vaccination. Prior to the vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Patient had no known allergies. Patient was not a pregnant at the time of vaccination. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Right on 23Mar2021 16:45 as dose 1, single for COVID-19 immunisation (Age at Vaccination was 31years). On 15Apr2021 02:00, the patient experienced dizziness, chills, fever, nausea and diarrhea. Therapeutic measures were taken as a result of events include Tylenol. The outcome of the events was not recovered.  No follow-up attempts are possible. Information on the lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rash, Vaccination site pain
Clinical narrative: Normal soreness around injection site/ tenderness at the injection site; 5-6 days post injection a small rash; soreness in the entire arm developed; This is a spontaneous report from a contactable other hcp (Patient). A 47-year-old non-pregnant female patient received BNT162B2 (Pfizer COVID-19 Vaccine, Batch/Lot Number: EP7533 Expiration Date: Unknown) via an unspecified route of administration, administered in Left Arm on 05Apr2021 02:45 (at the age of 47-year old) as DOSE 1, SINGLE for COVID-19 immunization. Medical history :None. concomitant medications were not reported. 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 received 1st dose of COVID-19 vaccine on 05Apr2021 02:45 AM. On 09Apr2021 01:00 The patient experienced normal soreness around injection site occurred 1-2 days after the injection. 5-6 days post injection a small rash the size of a penny was seen on the arm that received the injection. The rash went away in 2-3 days. Soreness in the entire arm developed. There was mild pain with movement and injection site was very sore to touch. 10 days post injection, soreness in the arm subsided substantially and tenderness at the injection site subsided as well. Patient did not receive any treatment. Outcome of all events was recovered.   No follow up attempts are possible. No further information is expected.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Diarrhoea, Skin erosion
Clinical narrative: Joint pain, hips; Chills; Diarrhea - feels like hot fire water coming out, to the point my skin is raw around my anus; Diarrhea - feels like hot fire water coming out, to the point my skin is raw around my anus; Joint pain, hips; Chills; Diarrhea - feels like hot fire water coming out, to the point my skin is raw around my anus; Diarrhea - feels like hot fire water coming out, to the point my skin is raw around my anus; This is a spontaneous report from a contactable healthcare professional (patient). A 65-years-old (non-pregnant) female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Batch/Lot Number: ER8727), dose 1 via an unspecified route of administration on 22Mar2021 at 15:00 (at the age of 65-years-old) as dose 1, single and dose 2 via an unspecified route of administration on 12Apr2021 (at the age of 65-years-old) (Batch/Lot Number: ER8729) as dose 2, single for COVID-19 immunisation. Medical history included atrial fibrillation (AFib), blood pressure, known allergies includes, penicillin allergy and allergy to sulfur drugs from unspecified dates. Concomitant medications/other medications the patient received within 2 weeks of vaccination included menthol, thymol (SOTOL), rivaroxaban (XARELTO), trazodone, sertraline and valsartan all taken for unspecified indication, start and stop dates were not reported (MANUFACTURER UNKNOWN). Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within four weeks prior to the vaccination. On an unspecified date in 2021, after the first dose, the patient experienced joint pain, hips, chills, diarrhea - felt like hot fire water coming out to the point her skin was raw around anus. On 15Apr2021 at 12:00, the patient experienced joint pain, hips, chills, diarrhea - felt like hot fire water coming out to the point her skin was raw around anus. It was reported that the patient didn't put two and two together until the today (the day of reporting). The patient reported stating the very same thing happened after first vaccine (on an unspecified date in 2021). The patient thought it was a bug. This lasted 24 hours before. Trying to stay hydrated. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events joint pain, hips, chills and diarrhea - feels like hot fire water coming out, to the point my skin is raw around my anus had recovered on unspecified date (lasted 24 hours); events occurred on 15Apr2021 at 12:00 was reported as recovering at the time of this report.   No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Salivary hypersecretion
Clinical narrative: itching; mild rash; excessive mouth watering; This is a spontaneous report from a contactable consumer or other non hcp. A 62-years-old non-pregnant female patient 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, administered in Arm Left on 23Mar2021 at 09:00 (at the age of 62-years-old) as dose 1, single for covid-19 immunisation. Medical history included coronary artery disease, known allergies: Penicillin and known allergies: Latex. Concomitant medication included celecoxib (CELEXA [CELECOXIB]), pravastatin sodium (PRAVACHOL), clonazepam (KLONOPIN), hydroxyzine (ATARAX [HYDROXYZINE]) and famotidine (PEPCID [FAMOTIDINE]). The patient previously took keflex [cefalexin] and experienced drug hypersensitivity, clindamycin and experienced drug hypersensitivity. The patient previously took Keflex and experienced known allergies: Keflex. The patient previously took Clindamycin and experienced known allergies: Clindamycin. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On an unknown date the patient experienced itching, mild rash and excessive mouth watering. The outcome of all the events was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Pain, Pyrexia
Clinical narrative: headache; injection site pain; body pain; fatigue; fever; chills; This is a spontaneous report from a non-contactable consumer (patient). A 20-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 04Apr2021 (at the age of 20-years-old) as dose 2, single for covid-19 immunization at hospital. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 14Mar2021 08:00 am (at the age of 20-years-old) as dose 1, single for covid-19 immunization at hospital and experienced injection site pain for 3 day. Patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 04Apr2021 09:00pm the patient experienced injection site pain, body pain, fatigue, fever, chills for 3 days. headache for 5 days. The patient took some ibuprofen as treatment. Therapeutic measures were taken as a result of headache, injection site pain, body pain, fatigue, fever, chills. The outcome of the event headache was recovered on 09Apr2021 and outcome of events injection site pain, body pain, fatigue, fever, chills was recovered on 07Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: headache; injection site pain; body pain; fatigue; fever; chills; This is a spontaneous report from a non-contactable consumer (patient). A 20-year-old non pregnant female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration on 04Apr2021 (at the age of 20-years-old) as dose 2, single for covid-19 immunization at hospital. The patient medical history and concomitant medications were not reported. The patient historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, formulation: solution for injection, lot number was not reported, expiration date was not reported), via an unspecified route of administration, administered in left arm on 14Mar2021 08:00 am (at the age of 20-years-old) as dose 1, single for covid-19 immunization at hospital and experienced injection site pain for 3 day. Patient did not receive any other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. It was reported that on 04Apr2021 09:00pm the patient experienced injection site pain, body pain, fatigue, fever, chills for 3 days. headache for 5 days. The patient took some ibuprofen as treatment. Therapeutic measures were taken as a result of headache, injection site pain, body pain, fatigue, fever, chills. The outcome of the event headache was recovered on 09Apr2021 and outcome of events injection site pain, body pain, fatigue, fever, chills was recovered on 07Apr2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: fatigue; fever; chills; This is a spontaneous report from a contactable consumer (patient) reported for self. A 71-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EN6208), via an unspecified route of administration, administered in arm left on 16Mar2021 at 12:00 (at the age 71-year-old) as dose 1, single, and second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot Number: EW0151), via an unspecified route of administration, administered in arm left on 08Apr2021 12:00 (at the age 71-year-old) as dose 1, single for COVID-19 immunization (Hospital). Medical history included COVID-19 in mid Dec2020. Patient had no known allergies. Concomitant medications included simvastatin; and hydrochlorothiazide, triamterene (TRIAMTERENE/HCTZ). Patient had covid prior vaccination. Patient had not been covid tested post vaccination. Patient has not received any other vaccines in four weeks. On 12Apr2021 at 12:00, the patient experienced fatigue, fever, and chills. It was reported that approximately 4 days after both inoculations patient experienced events which were very similar to symptoms while suffering from COVID-19. Therapeutic measures were taken as a result of events included Ibuprofen, Tylenol. The outcome of the events was recovered on an unknown date in 2021.  No follow-up attempts are possible. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Erythema, Fatigue, Headache, Myalgia
Clinical narrative: exhaustion; my arm became red and swollen; my arm became red and swollen; chills; muscle ache; headache; racing heart; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0151), via an unspecified route of administration, administered in arm left on 10Apr2021 as dose 2, single for covid-19 immunization. Patient relevant medical history includes high blood pressure and bee sting allergies. The patient known allergies hydrocodone and levequin. The patient concomitant medications includes Hydrochlorothiazide (Hctz 25mg). The patient was not pregnant at the time of vaccination. Patient receive other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: Er8727), dose 1, administered in arm left on 03Mar2021 11.00 Am for covid-19 immunization. The first dose the patient had only a sore arm but a couple of weeks later, was severely fatigued. With the 2nd dose, her arm became red and swollen the next day on 11Apr2021 and on 11Apr2021, the patient also experienced chills, muscle ache, headache, racing heart and total exhaustion. After 4 days, arm was still red, swollen and itchy. Still exhausted with racing heartrate. The patient did not received any treatment for adverse event. The patient did not had covid prior to vaccination. The patient did not tested for covid post vaccination. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Peripheral swelling
Clinical narrative: exhaustion; my arm became red and swollen; my arm became red and swollen; chills; muscle ache; headache; racing heart; This is a spontaneous report from a contactable consumer (patient). A 60-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0151), via an unspecified route of administration, administered in arm left on 10Apr2021 as dose 2, single for covid-19 immunization. Patient relevant medical history includes high blood pressure and bee sting allergies. The patient known allergies hydrocodone and levequin. The patient concomitant medications includes Hydrochlorothiazide (Hctz 25mg). The patient was not pregnant at the time of vaccination. Patient receive other vaccines within 4 weeks prior to the COVID vaccine. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, batch/lot number: Er8727), dose 1, administered in arm left on 03Mar2021 11.00 Am for covid-19 immunization. The first dose the patient had only a sore arm but a couple of weeks later, was severely fatigued. With the 2nd dose, her arm became red and swollen the next day on 11Apr2021 and on 11Apr2021, the patient also experienced chills, muscle ache, headache, racing heart and total exhaustion. After 4 days, arm was still red, swollen and itchy. Still exhausted with racing heartrate. The patient did not received any treatment for adverse event. The patient did not had covid prior to vaccination. The patient did not tested for covid post vaccination. The outcome of the events was recovering.   No follow-up attempts are possible; information about lot/batch number cannot been obtained.  No follow-up attempts are possible; information about lot/batch number cannot been obtained.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Pruritus
Clinical narrative: blister like, itchy bumps on my arms that then spread to my legs; blister like, itchy bumps on my arms that then spread to my legs; This is a spontaneous report from a contactable Other Health Care Professional (Patient).  A 47-years-old non pregnant 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 02Apr2021 08:00 (at the age of 47-years-old) (Batch/Lot Number: EP6955) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included Diabetes, blood pressure, asthma, depression, anxiety and covid-19 prior vaccination, all from an unknown date and unknown if ongoing. Concomitant medication included alprazolam 25mg, acetylsalicylic acid 81mg (ASPRIN) and cranberry 500mg all drugs were taken for an unspecified indication, start and stop date were not reported. Patient had known allergies to statins, estrogen and Lisinopril. Patient previously took first dose of bnt162b2 (Lot number: EN6206) administered in Left arm on 12Mar2021 04:00 PM (at the age of 47-years-old) for covid-19 immunisation. Patient did not have pregnancy at time of vaccination. Patient did not receive any other vaccine in four weeks. The patient experienced blister like, itchy bumps on my arms that then spread to my legs on 09Apr2021 08:00, 1 week after second shot. It was reported that, she tried Benadryl first and that did not work then cortisone 10 and that didn't work. She even tried essential oils of lavender and teatime and that didn't work. Today (on reporting date) she went to urgent care and got a prednisone shot for the events. Post vaccination patient did not test for covid. The Outcome of events were not recovered.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: mild fever; This is a spontaneous report from a contactable consumer (patient). A 33-years-old non-pregnant female patient 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, administered in left arm on 15Mar2021 at 09:30 as dose 1, single for covid-19 immunization. The patient medical history included hypothyroidism. The concomitant medications included ibuprofen (ADVIL 12 HOUR). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. The patient was not tested for COVID-19 since the vaccination. On an unspecified date, the patient had experienced mild fever. The outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Agitation, Chills, Discomfort, Fatigue, Headache
Clinical narrative: high fever/fever 101.7F/fever 100.3F; chills; fatigue; headache; heavy feeling effecting whole head; agitated by movement; discomfort also at the neck just below the back of the head; pressure at the nose bridge, waxes and wanes in intesity; This is a spontaneous report from a contactable consumer(patient) other health care professional (HCP). A 22-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot Number: ER8734), via an unspecified route of administration in left arm on 08Apr2021 at 12:00 (at the age of 22 years old) as dose 2, single for covid-19 immunisation. Medical history included hypertension. The patient had no known allergies. Concomitant medications in two weeks included amlodipine besilate (AMLODIPINE BESILATE); duloxetine. Historical vaccine included first dose of BNT162B2 (Lot number: EP7534), via an unspecified route of administration in left arm on 18Mar2021 at 08:00 PM for covid-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has been tested for COVID-19. On 08Apr2021 at 19:00 patient experienced 4/8 evening: high fever; chills; fatigue; headache (heavy feeling effecting whole head, positional and shifting from front to rear and vice versa, agitated by movement, discomfort also at the neck just below the back of the head). This headache persists until noted 4/9 fever 101.7F; chills; fatigue; (using Ibuprofen and Acetaminophen at this point and continuing) 4/10 fever 100.3F; chills and fatigue gone; tested negative for COVID 4/11 temperature normal; started Medrol dose pack for persistent headache (headache is the only symptom at this point) 4/12 headache at 15% of the worst, now a 2-3/10 discomfort level (headache is now primarily frontal, all across the forehead from temple to temple, also pressure at the nose bridge, waxes and wanes in intesity) 4/13 Emergency Room visit for persistent headache; head CT was done-normal; received benadryl, reglan, and toradol IV which eliminated the headache 4/14 same headache as described 4/12 returns 4/15 to current: headache persists. The patient underwent lab tests and procedures which included sars-cov-2 antibody test (Nasal Swab, LUMIRADX SARS-COV-2 AG TEST): negative on 10Apr2021. Therapeutic measures were taken as a result of high fever/fever 101.7f/fever 100.3f, chills, fatigue, headache, heavy feeling effecting whole head, agitated by movement, discomfort also at the neck just below the back of the head, pressure at the nose bridge, waxes and wanes in intensity with medrol dose pack; IV benadryl, reglan, and Toradol. The patient visited emergency room for persistent headache. The outcome of events was not recovered.  No follow-up attempts are possible. No further information is expected.