chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Rash papular, Rash pruritic
Clinical narrative: Itchy patch on neck Thursday, by Friday afternoon, upper body covered with itchy rash / Rash gone by Monday evening; No blisters, just raised areas; The patient received the third/booster dose of BNT162b2; This is a spontaneous report from a non-contactable consumer, the patient. A 73-year-old non-pregnant female patient received the third (booster) dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 08Nov2021 at 10:45 (at the age of 73-years-old) as a single dose for COVID-19 immunisation. The patient had no medical history. The patient did not take any concomitant medications. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient previously received nitrofurantoin (MACRODANTIN) and experienced drug allergy. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in right arm on 05Mar2021 at 12:00 (at the age of 72-years-old) and also received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 26Mar2021 at 11:00 (at the age of 72-years-old) as a single dose for COVID-19 immunisation. On 11Nov2021 at 18:00 (Thursday), after the third shot on 08Nov2021 (Monday), the patient experienced itchy patch on neck, by 12Nov2021 (Friday) afternoon, her upper body was covered with itchy rash. There were no blisters, just raised areas. The rash was gone by 15Nov2021 (Monday) evening. 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. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events itchy patch on neck, upper body covered with itchy rash and no blisters, just raised areas was resolved on 15Nov2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Thrombosis
Clinical narrative: I got a Blood clot in the bottom of my foot and I am very concerned; This is a spontaneous report from a contactable consumer.  A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) dose 2 via an unspecified route of administration on 24Apr2021 (Batch/Lot Number: EW0167; Expiration Date: Aug2021) as dose 2, single for COVID-19 immunisation.  The patient medical history and concomitant medications were not reported. The patient previously took BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection) dose 1 on unspecified date for COVID-19 immunisation.  The patient stated, "I am calling because my Pharmacist suggested that I call and I have been in a "quarantine" (further not clarified) for 8 months. I had my Pfizer vaccine, I had my second (dose) Pfizer vaccine on 24Apr2021 and then next day (25Aug2021), I got a blood clot in the bottom of my foot and I have seen my Doctor and had series blood test and I am trying to feel what is going on. I have the history of good health and no never had a blood clot, never had any issue before taken that vaccine for my life, I never had any issues. Now I am just like, if I am not going to booster vaccine but I am very concerned about what to do next, I don't know about taking the Booster shot (Covid-19 Vaccine) that concerns me. You guys are Pharmacist suggest me, you guys maybe having some ideas or something." The outcome of the event was unknown.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Eating disorder, Head discomfort, Insomnia, Vertigo
Clinical narrative: Has a little bit of vertigo, also had vertigo about 15 years ago; maybe the vertigo came from not really eating properly; Head sort of feels cloudy or stuffy; He didn't really eat very good yesterday; Dizzy; Light headedness; He didn't sleep really good last night; This is a spontaneous report from a contactable consumer. This consumer reported for male patient that: A 74-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; solution for injection, Lot Number: EN6200), via an unspecified route of administration, in left arm on 25Feb2021 (at the age of 74-year-old) as a dose 1, single for COVID-19 immunization. The patient medical history included chronic obstructive pulmonary disease and vertigo (also had vertigo about 15 years ago). The concomitant medication of the patient included tiotropium bromide (SPIRIVA), budesonide, formoterol fumarate (SYMBICORT) and albuterol sulfate (ALBUTEROL SULFATE) all for chronic obstructive pulmonary disease. On an unspecified date the patient experienced a little bit of vertigo, also had vertigo about 15 years ago; maybe the vertigo came from not really eating properly, head sort of feels cloudy or stuffy, didn't really eat very good yesterday, dizzy, light headedness and didn't sleep really good last night. The reporter stated that patient had a little bit of vertigo it started around say 11 o'clock morning. Patient head sort of feels cloudy or stuffy. The reporter and the patient did not know whether it either of those could be those symptoms from the shot or might be something else. Patient had not really eaten very good yesterday and, also had vertigo about 15 years ago. Reporter was thinking maybe the vertigo came from not really eating properly and reported that patient still having some lightheadedness and dizzy. Reporter stated, patient did not take any treatment, he took only his normal medication. Reporter was provided with the number of Pfizer medical information. The outcome for all the reported events was unknown. No follow up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Rhinorrhoea, Secretion discharge
Clinical narrative: This is a spontaneous report from a contactable consumer (reported for a female) via Pfizer sponsored program support.A female patient of an unspecified age received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot number was not reported) via an unspecified route of administration on 23Feb2021 as DOSE 1, SINGLE for COVID-19 immunisation. The patient medical history was not reported. Concomitant medications included dextromethorphan hydrobromide, doxylamine succinate, ephedrine sulfate, ethanol, paracetamol (Nyquil) taken for an unspecified indication from 15Mar2021 to an unspecified date. On an unspecified date, patient experienced cold, mucus or nasal discharge (secretion discharge, rhinorrhoea) and congestion. Caller stated that his fiance and himself received their first dose on 23Feb2021. They have colds and mucus or nasal discharge; inquired as if they should continue to get second dose on 16Mar2021. Therapeutic measures were taken as a result of events which included treatment with Nyquil for congestion on 15Mar2021. The outcome of events was unknown.No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Sinus congestion, Sinusitis
Clinical narrative: sinus congestion and stuff; sinus infection occurred 4 days ago from today; This is a spontaneous report from a contactable consumer or other non-healthcare professional (Patient). A 24-years-old male patient received bnt162b2 (COMIRNATY PFIZER-BIONTECH COVID-19 VACCINE Formulation: Solution for injection, Batch No. not available/lot Number: unknown, Expiration Date: unknown), via an unspecified route, administered in left arm on 25Feb2021 at 15:00 (at the age of 24 years old), as DOSE 1, SINGLE for covid-19 immunization. The patient medical history and concomitant medications were not reported. Prior vaccinations within 4 weeks were none. Additional vaccines administered on same Date of the Pfizer suspect was none. The reporter stated that, he was calling about the Pfizer COVID Vaccine and had some general questions and stated that he had the 1st dose of the Pfizer COVID Vaccine and then as of 4 days ago he got a sinus infection and got a covid test to make sure he was not positive, and the test came back negative. Stated that he was now wondering if it was ok to get the 2nd dose of the vaccine as he was currently taking Azithromycin and has no fever or anything. The reporter stated that, he got the 1st dose of the Pfizer COVID Vaccine 3 weeks ago from today and it was administered on 25Feb2021, and the sinus infection occurred 4 days ago from today and began on 14Mar2021 and stated that the sinus infection was ongoing and was about the same as when it began. The reporter stated that for treatment he was taking Azithromycin 250mg one tablet per day by mouth and is taking Mucinex but does not know the dosage of the Mucinex and stated that he had no lot numbers, expiry dates or NDC numbers for the Azithromycin or the Mucinex with him at this time to provide. The reporter stated that, he had some sinus congestion and stuff, and it was not related to the vaccine itself but more related to his seasonal allergies that he always gets and always gets a sinus infection around this time of year. The reporter stated that, he did go to see a HCP virtually to get the medication for the sinus infection but did not go to a physical HCP office. He had a COVID test yesterday 17Mar2021 and stated that it was negative for COVID. Therapeutic measures were taken as a result of the event. The outcome of the event was not resolved at the time of this report. No follow up attempts are possible. Information about lot/batch number cannot been obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Lymphadenopathy, Mental fatigue, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 40-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 26Apr2021 at 16:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no allergies to medications, food, or other products. Concomitant medication included spironolactone (SPIRONOLACTON) from an unknown date, for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 05Apr2021 at 16:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 27Apr2021, the next day of vaccination at 09:00, the patient experienced site soreness, fatigue (physical and mental) and swollen lymph node around left side collar bone; on the following evening, the patient experienced fever 100 (body temperature). The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. On 27Apr2021, body temperature for the patient was 100 (unit not specified). The clinical outcome of the events site soreness, fatigue (physical and mental), fever 100 and swollen lymph node around left side collar bone was recovering.No follow-up attempts are needed; information about lot/batch number cannot be obtained.Amendment: This follow-up report is being submitted to amend previously reported information: updated laboratory data (Body temperature date updated to be 27Apr2021), onset date for Fever updated to be 27Apr2021 and narrative data amended.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 40-years-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 26Apr2021 at 16:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. The patient did not have any medical history. The patient had no allergies to medications, food, or other products. Concomitant medication included spironolactone (SPIRONOLACTON) from an unknown date, for unspecified indication. The patient previously received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: unknown) via an unspecified route of administration in the left arm on 05Apr2021 at 16:00 (at the age of 40-years-old) as a single dose for COVID-19 immunisation. 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 vaccination. On 27Apr2021, the next day of vaccination at 09:00, the patient experienced site soreness, fatigue (physical and mental) and swollen lymph node around left side collar bone; on the following evening, the patient experienced fever 100 (body temperature). The events resulted in doctor or other healthcare professional office/clinic visit. The patient did not receive any treatment for the events. On 27Apr2021, body temperature for the patient was 100 (unit not specified). The clinical outcome of the events site soreness, fatigue (physical and mental), fever 100 and swollen lymph node around left side collar bone was recovering.No follow-up attempts are needed; information about lot/batch number cannot be obtained.Amendment: This follow-up report is being submitted to amend previously reported information: updated laboratory data (Body temperature date updated to be 27Apr2021), onset date for Fever updated to be 27Apr2021 and narrative data amended.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea
Clinical narrative: a little harder to breathe; some chest heaviness; This is a spontaneous report from a contactable consumer (patient) reported herself.   A 25-years-old non-pregnant female patient received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, Solution for injection, Batch/Lot number: ER8737) via an unspecified route of administration in left arm on 20Apr2021 at 11:00 (age at vaccination 25 years and non-pregnant at the time of vaccination) as dose 2, single for COVID-19 immunisation. The patient's medical history included hypothyroidism from an unknown date and unknown if ongoing. Concomitant medications included levothyroxine sodium (SYNTHROID) and paracetamol (TYLENOL); both were taken for an unknown indication from an unknown date to unknown if ongoing. The patient previously took z-pak and experienced drug allergy. The patient previously received bnt162b2 (Pfizer-BioNTech COVID-19 Vaccine, solution for injection, Batch/Lot number: EN6205) via an unspecified route of administration in left arm on 15Mar2021 at 14:00 as dose 1, single for COVID-19 immunisation and experienced lot more joint pain since first dose (achy, throbbing, tingling in hands, feet, arms, knees). On an unknown date in Apr2021, the patient woke up night of 2nd dose noticed it was a little harder to breathe, this really has not gone away and some chest heaviness. There was no COVID prior vaccination. There was no COVID tested post vaccination. Adverse events resulted in doctor or other healthcare professional office/clinic visit. There was no received any treatment. The outcome of events was reported as not recovered. No follow-up attempts are possible. No further information was expected.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Nausea, Pain
Clinical narrative: Random sharp pains through out my body; Random sharp pains through out body, foot, leg, hand, arm.; Random finger pain at joint; Nausea; Fatigue; Bad headache/Bad sharp pains in the back of head; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 03May2021 at 14:45 (at the age of 24-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient reported as shellfish, peanuts in past drugs. Concomitant medications included salbutamol (VENTOLIN), montelukast sodium (SINGULAIR) and cetirizine hydrochloride (ZYRTEC), all started on unknown date within 2 weeks of vaccination for an unknown indication. 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 vaccination. On 03May2021 at 15:30, the patient experienced random sharp pains throughout body, foot, leg, hand, arm bad sharp pains in the back of head and random finger pain at joint that developed after shot, hurts to the touch, nausea, fatigue and bad headache. The clinical outcome of the events random sharp pains throughout body, foot, leg, hand, arm bad sharp pains in the back of head and random finger pain at joint that developed after shot, hurts to the touch, nausea, fatigue and bad headache was not recovered.   The adverse events did not result in doctor or other healthcare professional office/clinic visit or emergence room. No treatment received  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported  1. known_allergies: Shellfish, peanuts captured as RMH 2. Treatment Received updated to NO for all AEs 3.  "The adverse events did not result in doctor or other healthcare professional office/clinic visit or emergence room. No treatment received" added in narrative
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Random sharp pains through out my body; Random sharp pains through out body, foot, leg, hand, arm.; Random finger pain at joint; Nausea; Fatigue; Bad headache/Bad sharp pains in the back of head; This is a spontaneous report from a contactable consumer, the patient. A 24-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 03May2021 at 14:45 (at the age of 24-year-old), as a single dose for COVID-19 immunisation. Medical history included asthma. The patient reported as shellfish, peanuts in past drugs. Concomitant medications included salbutamol (VENTOLIN), montelukast sodium (SINGULAIR) and cetirizine hydrochloride (ZYRTEC), all started on unknown date within 2 weeks of vaccination for an unknown indication. 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 vaccination. On 03May2021 at 15:30, the patient experienced random sharp pains throughout body, foot, leg, hand, arm bad sharp pains in the back of head and random finger pain at joint that developed after shot, hurts to the touch, nausea, fatigue and bad headache. The clinical outcome of the events random sharp pains throughout body, foot, leg, hand, arm bad sharp pains in the back of head and random finger pain at joint that developed after shot, hurts to the touch, nausea, fatigue and bad headache was not recovered.   The adverse events did not result in doctor or other healthcare professional office/clinic visit or emergence room. No treatment received  No follow-up attempts are needed; information about lot/batch number cannot be obtained.  Amendment: This follow-up report is being submitted to amend previously reported  1. known_allergies: Shellfish, peanuts captured as RMH 2. Treatment Received updated to NO for all AEs 3.  "The adverse events did not result in doctor or other healthcare professional office/clinic visit or emergence room. No treatment received" added in narrative
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Migraine, Nausea
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 30Apr2021 16:45 as DOSE 2, SINGLE for COVID-19 immunisation. Patient's Medical history and concomitant medications were not reported.The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 16:45 as DOSE 1, SINGLE for COVID-19 immunisation. On 01May2021 03:00, the patient experienced i woke up at 3 am the next morning with a severe migraine, feeling very fatigued/i was very tired all day, nauseous, chills, low grade fever, i would describe the migraine as a throbbing pain in my frontal lobe, i was sensitive to any light, On 01May2021 21:00, When the patient tried to go to bed that night around 9 pm i laid down and began to feel very nauseous and when i got up to go to the bathroom i began throwing up. i vomited until 1 am the next morning, On 02May2021, i felt weak the whole day.Therapeutic measures were taken as a result of i woke up at 3 am the next morning with a severe migraine, feeling very fatigued/i was very tired all day, nauseous, chills, low grade fever, i would describe the migraine as a throbbing pain in my frontal lobe, i was sensitive to any light included treatment herself with paracetamol (TYLENOL). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.The patient took 1000 mg of Tylenol every 4 hours until she reached 4000 mg and her migraine never went away. when she tried to sleep, she could feel the migraine still.The Tylenol and sleep did not help the migraine at all. Every time the patient thought she was done and she would lay back down and try to sleep her stomach kept turning and she kept getting up to vomit and finally the patient was able to fall asleep at 1:30. On 03May2021, the patient was tired, but okay.The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown, if the patient received treatment for the throwing up/vomited and felt weak the whole day. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events that night around 9 PM I laid down and began to feel very nauseous and when I got up to go to the bathroom I began throwing up. I vomited until 1 AM the next morning, I felt weak the whole day were resolved on 02May2021 at 01:00 and other events were resolved on an unspecified date in 2021.No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Photophobia, Pyrexia, Vomiting
Clinical narrative: This is a spontaneous report from a non-contactable consumer (patient). A 25-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE,Solution for injection,Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm Left on 30Apr2021 16:45 as DOSE 2, SINGLE for COVID-19 immunisation. Patient's Medical history and concomitant medications were not reported.The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration in the left arm on 09Apr2021 at 16:45 as DOSE 1, SINGLE for COVID-19 immunisation. On 01May2021 03:00, the patient experienced i woke up at 3 am the next morning with a severe migraine, feeling very fatigued/i was very tired all day, nauseous, chills, low grade fever, i would describe the migraine as a throbbing pain in my frontal lobe, i was sensitive to any light, On 01May2021 21:00, When the patient tried to go to bed that night around 9 pm i laid down and began to feel very nauseous and when i got up to go to the bathroom i began throwing up. i vomited until 1 am the next morning, On 02May2021, i felt weak the whole day.Therapeutic measures were taken as a result of i woke up at 3 am the next morning with a severe migraine, feeling very fatigued/i was very tired all day, nauseous, chills, low grade fever, i would describe the migraine as a throbbing pain in my frontal lobe, i was sensitive to any light included treatment herself with paracetamol (TYLENOL). Prior to vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine.The patient took 1000 mg of Tylenol every 4 hours until she reached 4000 mg and her migraine never went away. when she tried to sleep, she could feel the migraine still.The Tylenol and sleep did not help the migraine at all. Every time the patient thought she was done and she would lay back down and try to sleep her stomach kept turning and she kept getting up to vomit and finally the patient was able to fall asleep at 1:30. On 03May2021, the patient was tired, but okay.The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. It was unknown, if the patient received treatment for the throwing up/vomited and felt weak the whole day. Since the vaccination, the patient had not been tested for COVID-19. The outcome of events that night around 9 PM I laid down and began to feel very nauseous and when I got up to go to the bathroom I began throwing up. I vomited until 1 AM the next morning, I felt weak the whole day were resolved on 02May2021 at 01:00 and other events were resolved on an unspecified date in 2021.No follow-up attempts are required; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives; This is a spontaneous report based on the information received by Pfizer (Reference ID: NVSC2021US101382_NS) from a contactable Other HCP. A patient of unspecified age and gender received Unknown dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported) via unspecified route of administration and on unspecified date as dose number unknown, single for covid 19 immunisation. The medical history and concomitant medications were not reported. Few weeks later upon receiving the Pfizer vaccine the patient experienced hives. Outcome of the event was unknown. No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: After first dose I developed 3 small raised hives 0.5 mm in size on face; This is a spontaneous report from a contactable consumer, the patient. This is the first of two reports. A 61-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6203) via an unspecified route of administration in the left arm on 06Apr2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. Medical history included sulfonamide allergy. The patient did not receive any medication within two weeks of vaccination. The patient previously received MACROBID for unknown indication and experienced drug allergy. 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 vaccination. On 06Apr2021, after first dose, the patient developed 3 small raised hives 0.5 mm in size on face. The event resulted in doctor or other healthcare professional office/clinic visit. No therapeutic measures were taken as a result of the event. The clinical outcome of the event "after first dose the patient developed 3 small raised hives 0.5 mm in size on face" was not recovered at the time of this report. The patient received the second dose BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: EN6204) via an unspecified route of administration in the left arm on 27Apr2021 (at the age of 61-years-old) as a single dose for COVID-19 immunisation. No follow-up attempts are needed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Arthritis, Gout
Clinical narrative: Arthritic attacks in both hands, wrists,right elbow and left shoulder; gout; This is a spontaneous report from a contactable consumer. This 62-year-old male consumer (patient) reported for himself. A 62-year-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: ER8734), via an unspecified route of administration, administered in left arm on 13Apr2021 at 13:00 (at the age of 62-year-old) as a single dose for covid-19 immunisation. Medical history included coronary stents (2010) and gout flares (none in the past five years). The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and received other medications within 2 weeks of vaccination (unspecified medications). Patient had not been diagnosed with COVID-19 prior to vaccination and had not been tested since the vaccination. Patient had no known allergies. Historical vaccine included first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Solution for injection; Lot Number: EP7534), via an unspecified route of administration, administered in left arm on 23Mar2021 at 12:30 (at the age of 62-year-old) as a single dose for covid-19 immunisation. On 15Apr2021, patient experienced Arthritic attacks in both hands, wrists, right elbow and left shoulder and gout on an unspecified date in 2021. The attacks would migrate from place to place. The adverse event resulted in doctor or other healthcare professional office/clinic visit. Therapeutic measures were taken as a result of arthritis and gout included treatment with steroids. At the time of this report, the outcome of event arthritis was recovering, and gout was unknown.  No follow-up attempts are needed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Inflammation, Insomnia, Tinnitus
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 49-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0173), via an unspecified route of administration in the left arm on 14May2021 at 12:00 (at the age of 49-years-old), as a single dose of COVID-19 immunisation. The patient did not have any other medical history. The patient had no known allergies. The patient did not receive any other medications within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the right arm on 23Apr2021 at 12:00 (at the age of 49-years-old), as a single dose for COVID-19 immunisation and experienced tinnitus. 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 vaccination. On 15May2021 at 04:00, the patient experienced tinnitus in left ear, extremely difficult to sleep. This is 2nd night with rigging in ears and it was hard to take. Praying it gets better when inflammation decreases. Therapeutic measures were not taken as a result of the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the events tinnitus in left ear, 2nd night rigging in ears and it's hard to take, extremely difficult to sleep and it gets better when inflammation decreases were not resolved at the time of this report. No follow-up attempts are needed. No further information expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash
Clinical narrative: an itchy rash on the torso; an itchy rash on the torso; This is a spontaneous report from a contactable consumer, the patient. A 43-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EN5318) in the left arm on 25Mar2021 at 09:30 (at the age of 43-years-old) as a dose for COVID-19 immunisation. Medical history included allergy to metals (non-precious metals). Patient had no food or medication allergies. The patient did not receive any medication within two weeks of 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. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 25Mar2021, the patient experienced an itchy rash on the torso in the evening after receiving the first COVID vaccine that morning The patient did not receive any treatment for the events. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. The clinical outcome of the event itchy rash on the torso was unknown. No follow-up attempts are needed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Headache, Pyrexia, Vaccination site pain
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 38-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration in left arm on an unspecified date (at the age of 38 years-old) as dose 2, single for covid-19 immunization. Patient medical history was not reported. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with covid-19. Post vaccination, the patient had not been tested for covid-19. No other vaccine in four weeks. Concomitant medications included echinacea (ECHINACEA) and multivitamin [vitamins nos] (MULTIVITAMIN [VITAMINS NOS]) both taken for an unspecified indication, start and stop date were not reported. Historical vaccine included first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: not reported) via an unspecified route of administration in left arm on an 23Apr2021 at 10:00 (at the age of 38 years-old) as dose 1, single for COVID-19 immunization and reported that the injected arm was very sore to lift above shoulder level. On 15May2021 at 01:00, the patient reported that the injected arm was sore again, but not as bad. Possibly due to moving the arm more to prevent it from being sore, she had 102 temperature about 12 plus hours after the shot, accompanied with a headache and 24 hours after, she had about 100 temperature and 2 days later she felt better. The patient underwent lab tests and procedures which included body temperature: 102 degree (degree, about 12 plus hours after the shot) and body temperature: 100 degree (after 24 hours) on an unspecified date. Therapeutic measures were taken, and patient took 2 Advil to relieve the pain and it helped. The clinical outcome of all the events was resolved on an unspecified date in May2021. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Inappropriate schedule of product administration, Off label use
Clinical narrative: Sharp chest pain/Just began after 2nd dose. Pain more stabbing this time.; administration date: 27Mar2021, dose number: 1, administration date: 12May2021, dose number: 2; administration date: 27Mar2021, dose number: 1, administration date: 12May2021, dose number: 2; This is a spontaneous report from a non-contactable consumer or other non hcp(patient). A 19-years-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration, administered in Arm Left on 12May2021 at 19:15 (at the age of 19-years-old) as dose 2, single for covid-19 immunisation. The patient medical history was not reported. Patient has no known allergies. Other medical history was none. Patient was non pregnant at the time of vaccination. Other medications in two weeks was BCP (birth control pills). The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not having covid prior vaccination and has not been covid tested post vaccination. Patient previously received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number: not reported) via an unspecified route of administration, administered in Arm Right on 27Mar2021 19:15 (at the age of 19-years-old) as dose 1, single for covid-19 immunisation. 12May2021 19:15 patient experienced off label use and inappropriate schedule of vaccine administered. Patient experienced Sharp chest pain beginning 4 days on 16May2021 after vaccine. Happened after 1st dose as dull aching in chest, but resolved in 2 hrs. Just began after 2nd dose. Pain more stabbing this time. The outcome of the event Chest pain was not recovered.No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Disorientation, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: headache; Very dizzy- I feel like room is spinning- disoriented; Very dizzy- I feel like room is spinning- disoriented; chest pain; numbness in left arm; fatigue; brain fog; This is a spontaneous report from a contactable consumer (Patient). A 48-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8735, Expiry date was not reported), via an unspecified route of administration on 15May2021 12:30 (at the age of 48-year-old) in left arm as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. Concomitant medication(s) in two weeks included fluoxetine hydrochloride (PROZAC); bupropion hydrochloride (WELLBUTRIN); ketorolac tromethamine (TORADOL); prednisone; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); calcium citrate malate, colecalciferol (MALACAL) all taken for an unspecified indication, start and stop date were not reported. The Patient was not pregnant at the time of vaccination. The patient had no known allergies. The patient was not diagnosed with COVID prior vaccination. The patient was not tested COVID post vaccination. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: ER8734 and Expiry date was not reported), via an unspecified route of administration on 24Apr2021 12:30 (at the age of 48-year-old) right arm as dose 1, single for COVID-19 immunization. On 15May2021 20:00, the patient experienced headache, very dizzy- I feel like room is spinning- disoriented, chest pain, numbness in left arm, fatigue and brain fog. The patient did not receive treatment for the events. The outcome for the events was not recovered. Sender's Comments: Linked Report(s) : -PFIZER INC-2021516068 similar report from same reporter.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypoaesthesia
Clinical narrative: headache; Very dizzy- I feel like room is spinning- disoriented; Very dizzy- I feel like room is spinning- disoriented; chest pain; numbness in left arm; fatigue; brain fog; This is a spontaneous report from a contactable consumer (Patient). A 48-year-old non pregnant female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Batch/Lot Number: ER8735, Expiry date was not reported), via an unspecified route of administration on 15May2021 12:30 (at the age of 48-year-old) in left arm as dose 2, single for COVID-19 immunization at Pharmacy or Drug Store. The patient medical history was not reported. Concomitant medication(s) in two weeks included fluoxetine hydrochloride (PROZAC); bupropion hydrochloride (WELLBUTRIN); ketorolac tromethamine (TORADOL); prednisone; amfetamine aspartate, amfetamine sulfate, dexamfetamine saccharate, dexamfetamine sulfate (ADDERALL); calcium citrate malate, colecalciferol (MALACAL) all taken for an unspecified indication, start and stop date were not reported. The Patient was not pregnant at the time of vaccination. The patient had no known allergies. The patient was not diagnosed with COVID prior vaccination. The patient was not tested COVID post vaccination. Previously patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: solution for injection, Batch/Lot Number: ER8734 and Expiry date was not reported), via an unspecified route of administration on 24Apr2021 12:30 (at the age of 48-year-old) right arm as dose 1, single for COVID-19 immunization. On 15May2021 20:00, the patient experienced headache, very dizzy- I feel like room is spinning- disoriented, chest pain, numbness in left arm, fatigue and brain fog. The patient did not receive treatment for the events. The outcome for the events was not recovered. Sender's Comments: Linked Report(s) : -PFIZER INC-2021516068 similar report from same reporter.
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Patient received a FLUZONE QUADRIVALENT that was later noted to have expired with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-health care professional via Global Medical Information (Reference number- 00855893) and transmitted to Sanofi on 12-Nov-2021.  This case involves a female patient (age unknown) who had received an expired INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED [FLUZONE] (expired product administered).  The patient's medical history, medical treatment(s), past vaccination(s), concomitant medications and family history were not provided.   On 28-Oct-2021, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED produced by Sanofi Pasteur (lot number: UJ477AA and expiry date: 30-Jun-2021) via intramuscular route in unknown administration site for prophylactic vaccination.  It was a case of an actual medication error due to expired vaccine used (latency same day).  It was reported "Staffer is calling back to provide name of an expired vaccine June 2021, that was given to another staffer on October 28. The staffer wants to know if she needs to get another shot. She is unsure if it was with or without preservatives. health care professional (HCP) states that on 10/28/2021, an employee at one of their sites received a FLUZONE QUADRIVALENT vaccine that was later noted to have expired. Caller states that she was not present, does not know if vaccine was from a multi-dose vial or single dose presentation. She also does not know the national drug code (NDC) or the injection site. Telephone connection was very bad, incomplete patient specifics collected. Treatment-will be repeated".  No adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: ended up getting sicker than a dog; Initial information received on 08-Nov-2021 regarding an unsolicited case received from a consumer or non-healthcare professional.  This case involves adult patient (unknown demographic) who had ended up getting sicker than a dog (illness) after receiving INFLUENZA VACCINE.  The patient had no medical history, concomitant disease or risk factor.  The patient medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious ended up getting sicker than a dog (illness)  (illness) (unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events.  It was reported "The one and only time I got a flu shot was like 20 years ago, and I ended up getting sicker than a dog. Haven't gotten one since, and I'm rarely ever sick. I'll stick with that."  There were no lab data/results available.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: very sore arm for 2 to 3 days this time; Initial information received on 08-Nov-2021 regarding an unsolicited valid non-serious case from a consumer/non-health care professional via social media.  This case involves a patient (unknown age and gender) who had very sore arm for 2 to 3 days (pain in extremity), after receiving INFLUENZA VACCINE.  The patient's past vaccination(s) included Influenza vaccine and coronavirus disease 2019 (COVID-19) vaccine.  It was unknown if the patient had any other medical history, concomitant disease or risk factor.   Medical treatment(s), concomitant medication(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (lot number and expiration date were not reported) via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious very sore arm for 2 to 3 days this time (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  It was reported "why hidden didn't say anything bad, other years shot was not as sore in arm, i get stronger dose senior, i don't due shots well don't have fat arms, covid shots were less pain. got mine a week ago, very sore arm for 2-3 days this time."  It was unknown if the patient experienced any additional symptoms/events.  It was unknown if there were laboratory data/results available.   It was not reported if the patient received a corrective treatment.  At time of reporting, the outcome was unknown for the reported event.  There will be no information available on the batch number for this case.