chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash
Clinical narrative: platelet count was elevated above 400; sores on roof of mouth; immediate itching & rash on arm at site of injection; immediate itching & rash on arm at site of injection; mild asthma; This is a spontaneous report from a contactable consumer (Patient). A 49-year-old non-pregnant female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation solution for injection, Batch/Lot Number: ER8731) via an unspecified route of administration, administered in left arm on 24Apr2021 at 05:00 PM (at the age of 49-years-old) as dose 2, single for COVID-19 immunization in a clinic. Medical history included known allergies to seseme seeds and codeine. Prior to vaccination the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID-19 vaccination. Concomitant medication(s) included levothyroxine sodium (SYNTHROID, 100 mg); ergocalciferol (VIT D); tocopherol (VIT E), multivitamins and Tuna Oil; all were taken for an unspecified indication, start and stop date were not reported. The patient previously received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: ER8732) via an unspecified route of administration, administered in left arm on 03Apr2021 at 05:00 PM, as dose 1, single for COVID-19 immunization. On 24Apr2021 at 5:00 PM (after second shot), patient experienced sores on roof of mouth, platelet count was elevated above 400, immediate itching & rash on arm at site of injection for 7 days, mild asthma for 24 hours. The event platelet count was elevated above 400 was Serious (Medically Significant). The patient underwent lab test which included platelet count: elevated above 400 on 24Apr2021. Patient did not receive any treatment for the events. The outcome of the events was recovered.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Chest pain
Clinical narrative: Chest pain; discomfort in her chest; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (patient) reported that a 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration, administered in left arm on 03May2021 (Batch/Lot number was not reported) (at the age of 63 years old) as dose 2, single for COVID-19 immunisation. There were no patient's medical history and concomitant medications. The patient previously received BNT162B2 via unspecified route of administration, administered in left arm on 12Apr2021 (Batch/Lot Number: EW0162) as dose 1, single for COVID-19 immunisation. The patient reported that after second shot of the COVID vaccine she experienced a lot of chest pain. She had chest pain on 03May2021, the night after the shot. She had to have a stent put in her heart. The event required visit to Emergency Room and Physician Office. She went to the doctor trying to understand the discomfort in her chest. She went to urgent care and then lead her to the ER and to being admitted. The patient was hospitalized from the 29May2021 to the 03Jun2021, five days. No prior vaccinations (within 4 weeks). The outcome of the events was unknown.  No follow-up attempts are needed; information on Batch/Lot number cannot be obtained.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Autoimmune disorder, Blood test, Inflammation, Myalgia, Pain
Clinical narrative: Polymyalgia; inflammation of the muscles throughout the body/ all systems in the body, Her arm, leg, torso, everything; this is so dramatic and so painful; an autoimmune attack on her body; This is a spontaneous report from a contactable consumer or other non hcp. An 81-years-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: Unknown), via an unspecified route of administration, administered in Arm Left on 28Mar2021 (at the time of vaccination 81-years-old), as a SINGLE DOSE for COVID-19 immunization. The patient previously received first dose of BNT162B2 via an unspecified route of administration, administered in Arm Left on 07Mar2021 (at the time of vaccination 81-years-old), as a SINGLE DOSE for COVID-19 immunization. The patient's medical history included Guillain-Barre; when she was 19 years old, she was paralyzed; she has never been able take a flu vaccine until about two years ago she had her first one and a year ago she had her second one; and compromised immune status. The patient's concomitant medications were not reported. The patient did not have any vaccine prior vaccination within 4 weeks. On 20May2021, the patient experienced polymyalgia, and inflammation of the muscles throughout the body/ all systems in the body, her arm, leg, torso, everything; on an unspecified date 2021, this is so dramatic and so painful, and an autoimmune attack on her body. The patient underwent lab tests and procedures which included blood test: unremarkable on 28May2021, and blood test: sedimentation rate went down on 04Jun2021. The outcome of the events polymyalgia, inflammation of the muscles throughout the body/ all systems in the body, her arm, leg, torso, everything was not recovered; this is so dramatic and so painful, and an autoimmune attack on her body was unknown.  VACCINE SUPPLEMENTAL FORM: Details coded in narrative.  Information on the lot/batch number has been requested.  No follow-up attempts are completed; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Exposure via breast milk, Growth failure
Clinical narrative: Breastfeeding my 2 month old at the time; My milk supply significantly lowered so much that my child wasn't growing enough; This is a spontaneous report from a contactable consumer or other non hcp(patient's mother). A 2-months-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for Injection, Lot Number: ER8731), via unspecified route of administration, administered in Arm Left on 15Apr2021 13:15 as single dose for covid-19 immunization. The patients medical history was not reported. Concomitant medication(s) included sertraline (SERTRALINE) taken for an unspecified indication, start and stop date were not reported. The reporter reported that after receiving her first dose, inexperienced intense cramping and her period started the next day. She was breastfeeding her 2-month-old at the time and her milk supply significantly lowered so much that her/his child wasn't growing enough and had to switched to formula. When she breastfed her first child, she didn't get a period for 8 months, so she definitely think that it was related to the vaccine. This time she was only 2 months post pregnancy and although she was happy to get her vaccine this has been very hard for them and her postpartum depression. The outcome of the events was unknown.  Additional information has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021691747 mother/baby case
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: In Apr the patient had COVID, so the patient tested positive; In Apr the patient had COVID, so the patient tested positive; This is a spontaneous report from the Pfizer-sponsored program from a contactable pharmacist. A female patient of an unspecified age received BNT162B2, dose 1 via an unspecified route of administration on 26Mar2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The pharmacist reported that they have a patient who got the first dose of Pfizer COVID-19 vaccine last 26Mar2021, however in Apr2021 the patient had COVID, so the patient tested positive and the patient didn't get the second dose yet and they wanted to know when they should get the second dose? The pharmacist wanted to know when should be the second dose for the patient? Because the patient got COVID in Apr2021 and until now she didn't get the second dose. Because when she got COVID, she was in hospital for 2 weeks, so it was not a mild case of COVID that she had, The pharmacist would say it was probably a stronger case. The patient underwent lab tests and procedures which included Covid-19 test positive in Apr2021. The outcome of the events was unknown.    Information on Lot/ Batch number has been requested.; Sender's Comments: Based on narrative given in the case there is reasonable possibility of causal association between the event Drug ineffective, COVID-19 and the suspect product BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Inflammation, Uveitis, Vision blurred
Clinical narrative: the patient experienced Panuveitis flare up; the patient experienced Panuveitis flare up; blurred vision; inflammation; This is a solicited report from a non-Pfizer sponsored program received from a contactable consumer (patient), based on information received by Pfizer from Manufacturer Control Number: 21K-163-3939945-00).  A 59-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), dose 1 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose; dose 2 intramuscular on an unspecified date (Batch/Lot number was not reported) as single dose for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous from an unspecified date  and ongoing, at citrate free (as reported) for non-infectious intermediate, posterior and panuveitis.  The patient medical history and concomitant medications were not reported. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The patient experienced panuveitis flare up, blurred vision, inflammation. The reporter's causality for the event of Panuveitis flare up with Humira (adalimumab) was a reasonable possibility. The action taken in response to the events for adalimumab was dose not changed. The outcome of the events was not recovered.  No follow-up attempts are possible; information about batch/ lot number cannot be obtained.; Sender's Comments: Reported events are likely intercurrent and unrelated to BNT162B2.
Sex: F
Vaccine: COVID19
Symptoms: Hallucination, Headache, Lethargy
Clinical narrative: slight hallucination; headache; lethargy; This is a spontaneous report received from a contactable consumer. A adult female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date (Batch/Lot number unknown) as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunisation. Patient was not pregnant. The patient medical history and concomitant medications were not reported. 48 hours the patient experienced slight hallucination, headache, lethargy on an unspecified date with outcome of recovered on an unknown date. Treatment for adverse event was No. The events were reported as non-serious.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Malaise, Nausea, Paraesthesia oral, Pharyngeal swelling
Clinical narrative: Tired; Feeling ill/Not feeling well; My lips became tingly; Throat got swollen; Nausea; Tightness; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 40-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6198 and  Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 05Mar2021 at 09:40 as dose 1, single for covid-19 immunisation. Medical history included eczema (I had little bit of eczema but it is not bad.) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced throat got swollen, nausea on 05Mar2021 and tired, not feeling well and feeling ill on an unspecified date, tightness and my lips became tingly on 05Mar2021 at 09:45. The reporter stated, she had the first Pfizer shot on 05Mar2021 and within 5 minutes his throat got a bit swollen, her breathing was fine able to eat and drink with no problem and then at 9:45am within an hour her lips became tingly about 12:30PM she took some Motrin, and symptoms went away. Took Motrin the first time and then it happened again about 6 hours later that evening and took Benadryl and Motrin (treatment) and it gone away. She had the first shot at 9:40 AM and then at 12:30 took Motrin and that helped his throat and the lip at 18:00 both symptoms came back again and took Benadryl and Motrin and that help and 06Mar2021 and 07Mar2021 had regular symptoms feeling ill, not really unwell no more sore throat. That evening about 6pm -7pm my throat began to feel tight and her lips tingly at the same time, took Benadryl and Motrin, it went away, on March 6 and 7th had regular usual side effects, nausea, tired, and overall not feeling well and no other reactions. Consumer stated, That was the first shot. Didn't get the second shot. She took Benadryl and Motrin as a treatment for event. Therapeutic measures were taken as a result of event tightness, my lips became tingly. The outcome of the event were recovered  on an unspecified date and rest of the event were unknown.  Information on the lot/batch number has been requested.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Throat tightness
Clinical narrative: Tired; Feeling ill/Not feeling well; My lips became tingly; Throat got swollen; Nausea; Tightness; This is a spontaneous report from a contactable consumer or other non hcp (patient herself). A 40-year-old female patient received bnt162b2 (BNT162B2, Formulation: Solution for injection, Lot Number: EN6198 and  Expiry date was not reported) via an unspecified route of administration, administered in Arm Left on 05Mar2021 at 09:40 as dose 1, single for covid-19 immunisation. Medical history included eczema (I had little bit of eczema but it is not bad.) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced throat got swollen, nausea on 05Mar2021 and tired, not feeling well and feeling ill on an unspecified date, tightness and my lips became tingly on 05Mar2021 at 09:45. The reporter stated, she had the first Pfizer shot on 05Mar2021 and within 5 minutes his throat got a bit swollen, her breathing was fine able to eat and drink with no problem and then at 9:45am within an hour her lips became tingly about 12:30PM she took some Motrin, and symptoms went away. Took Motrin the first time and then it happened again about 6 hours later that evening and took Benadryl and Motrin (treatment) and it gone away. She had the first shot at 9:40 AM and then at 12:30 took Motrin and that helped his throat and the lip at 18:00 both symptoms came back again and took Benadryl and Motrin and that help and 06Mar2021 and 07Mar2021 had regular symptoms feeling ill, not really unwell no more sore throat. That evening about 6pm -7pm my throat began to feel tight and her lips tingly at the same time, took Benadryl and Motrin, it went away, on March 6 and 7th had regular usual side effects, nausea, tired, and overall not feeling well and no other reactions. Consumer stated, That was the first shot. Didn't get the second shot. She took Benadryl and Motrin as a treatment for event. Therapeutic measures were taken as a result of event tightness, my lips became tingly. The outcome of the event were recovered  on an unspecified date and rest of the event were unknown.  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram, Electrocardiogram abnormal, Myocarditis
Clinical narrative: Myocarditis,with abnormal EKG-they said this is just inflammation; Abnormal EKG; This is a spontaneous report from a contactable consumer (patient). This is report 1 of 3. A female patient of an unspecified age was reporting for herself that she was received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0176, NDC/Expiry: Not provided), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was received first dose of BNT162B2 on an unspecified date for Covid-19 immunization and no reaction on previous exposure to vaccine. On an unspecified date, the patient experienced myocarditis, abnormal Electrocardiogram (EKG) and inflammation. Additional context reported as the patient was consumer also patient for this report who got second dose of Pfizer Covid Vaccine and had adverse event of Myocarditis with onset 7 days after second dose-ended up in urgent care with abnormal EKG-they said this is just inflammation and it took 4 weeks to go away for her. Patient had first dose of Pfizer Covid Vaccine with different Lot number and had no problem after that first dose. The patient knows they are only talking about that with 19-year-old. They are all fine, but it might be an issue of bad batches of Lot numbers of Pfizer Covid Vaccine. They all recovered. The patient underwent lab tests and procedures which included EKG: abnormal on an unspecified date. Therapeutic measures were taken as a result of myocarditis, abnormal EKG. Outcome of the events was recovered.  Follow up attempts are needed. Additional information has been requested.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest pain, Myocarditis
Clinical narrative: Myocarditis,with abnormal EKG-they said this is just inflammation; Abnormal EKG; This is a spontaneous report from a contactable consumer (patient). This is report 1 of 3. A female patient of an unspecified age was reporting for herself that she was received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: EW0176, NDC/Expiry: Not provided), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient was received first dose of BNT162B2 on an unspecified date for Covid-19 immunization and no reaction on previous exposure to vaccine. On an unspecified date, the patient experienced myocarditis, abnormal Electrocardiogram (EKG) and inflammation. Additional context reported as the patient was consumer also patient for this report who got second dose of Pfizer Covid Vaccine and had adverse event of Myocarditis with onset 7 days after second dose-ended up in urgent care with abnormal EKG-they said this is just inflammation and it took 4 weeks to go away for her. Patient had first dose of Pfizer Covid Vaccine with different Lot number and had no problem after that first dose. The patient knows they are only talking about that with 19-year-old. They are all fine, but it might be an issue of bad batches of Lot numbers of Pfizer Covid Vaccine. They all recovered. The patient underwent lab tests and procedures which included EKG: abnormal on an unspecified date. Therapeutic measures were taken as a result of myocarditis, abnormal EKG. Outcome of the events was recovered.  Follow up attempts are needed. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from contactable consumer (patient) via Pfizer sponsored program. A female patient of an unspecified age received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine, Formulation: Solution for injection, Lot Number/Expiration Date: Unknown), via an unspecified route of administration on Mar 19, 2021 as dose 1, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient did not have an allergic reaction to the first dose. She reported that she got her first dose of the vaccine on Mar 19, 2021 and tested positive for COVID on Apr 2, 2021. She had a monoclonal antibody infusion on Apr 3, 2021 as treatment. She stated on Jul 3, 2021, it would be 90 days since she had the infusion. She was calling to ask if it was ok to take the second dose, or if she needs to start over again. At the time of report, outcome of events was unknown. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report from a contactable consumer, the patient. A 46-years-old male patient received bnt162b2 (Pfizer-BioNTech COVID-19 vaccine; formulation: solution for injection, Lot number was not reported), dose 1 via an unspecified route of administration on Mar 23, 2021, as dose 1, single, for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient stated that, after his 1st vaccine dose he went out of the country. Six weeks after his 1st Pfizer vaccine dose, he tested positive for COVID-19 and after 14 days of quarantine and medication, he then tested negative for COVID-19. He was also tested again before flying home and was still negative for COVID-19. He believed that the 1st Pfizer vaccine dose only covered him for certain strains, and being out of the country, he was exposed to another strain. The outcome of the events was recovered. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: His stroke started on 07Jun; This is a spontaneous report from a Pfizer sponsored program. consumer (patient) reported for himself that a 61-years-old male patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), dose 2 via an unspecified route of administration on 07May2021 (Age at Vaccination was 61 years) (Batch/Lot number was not reported) as DOSE 2, SINGLE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection), at single dose for COVID-19 im-munisation on 16Apr2021 and did not feel any symptoms with her first dose (Age at Vaccination was 61 years). Patient experienced stroke (medically significant) started on 07Jun2021 and is 99% sure due to the COVID vaccine. He mentions that he was an athlete and a pilot. He states that he was in excellent condition and have no family history of stroke. He also said that doctors did not know about anything. Caller wants to know if it can recur again in the future. Outcome of the event was unknown.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Bell's palsy, Facial paralysis
Clinical narrative: Bell's Palsy symptoms; facial paralysis right side of face; Loss of taste right side of tongue; This is a spontaneous report from a contactable consumer (the patient, reported for herself). A 26-year-old non-pregnant female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: EW0168 and expiry dates was unknown), via unspecified route of administration, in the right arm on 16Jun2021 12:15 PM (at the age of 26-year-old) as single dose for COVID-19 immunization at school or student health clinic. Medical history included bell's palsy (before), known allergies to penicillin, nuts, avocados and bananas. Concomitant medications were not reported. On an 17Jun2021 at 10:15 PM, patient experienced bell's palsy symptoms, facial paralysis right side of face and loss of taste right side of tongue. All the events resulted in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Patient was received treatment in response to the adverse events (Medication for the symptoms). Patient was not diagnosed with COVID-19 prior to vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine and did not receive any other medications within 2 weeks of vaccination. Patient has not been tested for COVID-19, post vaccination. Outcome for all the events was not recovered.   Follow-up attempts are needed. Further information is requested.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: received his first Pfizer Covid 19 Vaccine on 10March2021. The patient tested positive for Covid on 23March2021.; received his first Pfizer Covid 19 Vaccine on 10March2021. The patient tested positive for Covid on 23March2021.; This is a spontaneous report from a contactable Pharmacist. A 66-year-old male received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/lot number: unknown and Expire Date: unknown) via unspecified route of administration on 10Mar2021, as 1st dose single, for Covid-19 immunisation. Patient's medical history and concomitant medications were not reported. The patient tested positive for Covid on 23March2021. While in the hospital he received the monoclonal antibodies. He was advised by the MD that he would need to start the vaccination series over. Caller asked if the information is correct for restarting the vaccination. The patient underwent lab test which included Covid test as positive on 23Mar2021. The outcome of the events was unknown.   Information about batch/lot number has been requested.; Sender's Comments: Based on known drug safety profile, there is reasonable possibility of causal association between the Lack of efficacy, COVID-19 and BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE)
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID after getting both vaccines; Tested positive for COVID after getting both vaccines; This is a spontaneous report from a non-contactable consumer. A 23-years-old male patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 1 via an unspecified route of administration on 28Jan2021 (Batch/Lot Number: EN5318; Expiration Date: 31May2021) as DOSE 1, SINGLE for covid-19 immunization and BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE; Solution for injection), dose 2 via an unspecified route of administration on 17Feb2021 (Batch/Lot Number: EN5318; Expiration Date: 31May2021) as DOSE 2, SINGLE for covid-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tested positive for Covid after getting both vaccines on 14Jun2021. The patient underwent lab tests and procedures which included sars-cov-2 test on 14Jun2021 and found positive. It was reported that the patient's SARS-CoV2 antibodies at diagnosis were unknown. Patient was not patient hospitalized or admitted to an intensive care unit. Patient's clinical signs at rest indicative of severe systemic illness were unknown. The Patient did not require supplemental oxygen (including high flow or ECMO) or receive mechanical ventilation. Patient did not experience any new or worsened symptoms/signs or multiorgan failure during the COVID-19 illness experienced. The Patient did not require any additional therapies or initiation of new medication or other treatment or procedure for COVID-19. The patient did not provide any medical history or chronic illness. Patient's smoking habits or routinely medication was unknown. The patient's pre-existing diseases worsened during the SARS-CoV2 infection or patient been treated with immunomodulating or immunosuppressing medications or received any other vaccines around the time of COVID-19 vaccination were not provided. The sample of the product available to be returned, if requested and Packaging sealed, and intact information was not provided. The outcome of events was recovering.  Follow-up attempts are needed. Further information been requested
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood cholesterol, Erythema, Feeling abnormal, Full blood count, Peripheral swelling
Clinical narrative: I felt my legs like swelling; I had raised rash and both of them on both legs; they were red/I had scratchy redness on my arms; I had scratchy redness on my arms; raised rash; they just felt weird; This is a spontaneous report from a contactable consumer (patient).   A 49-years-old female patient received of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0191), via an intramuscular route on 21Jun2021 (at the age of 49-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included allergy. Patient allergic to medicines she don't take medicine because she always had a reaction to it like, like Morphine, Oxycodone, Ibuprofen, Tylenol. Patient don't took narcotics. The patient concomitant medications included cetirizine hydrochloride (ZYRTEC) tablet with dose 10 mg for allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jun2021 (5 minutes after vaccination), the patient experienced felt her legs like swelling that they just felt weird and within that 15 minutes after having the shot leg down and her legs, she had raised rash and both of them on both legs and they were red like red and so then, She had scratchy redness on my arms it's a reaction that she get when she take medicines and she had allergic reaction to them. Patient stated that wanted to have check up she had it last week. It's just the Blood test standard blood panel like CBC all the things just the mix of Cholesterol all that, Annual Blood work and said Yes everything was good. Patient took Diphenhydramine HCL (BENADRYL) tablet 25 mg as treatment. About 25 minutes after she got with the Pharmacist and he finally can get a thing It was about 25 minutes after the shot is when she got the Benadryl and it took about 30 minutes from the Benadryl 20-30 minutes that the redness is at least went down, she still had the raised rash but her legs were not red like red they were and now she was at home and it's pretty much subsided the reaction, she don't have the scratchiness and stuff she had few little spots here and there but not anything. The outcome of the events was recovering.  Time (24hr) of vaccination: Consumer stated, "My appointment was at 2:30 but I think it was about 2:35 time I got it I don't know about 2:35, 2:40 something central time."  Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash, Rash papular, Scratch
Clinical narrative: I felt my legs like swelling; I had raised rash and both of them on both legs; they were red/I had scratchy redness on my arms; I had scratchy redness on my arms; raised rash; they just felt weird; This is a spontaneous report from a contactable consumer (patient).   A 49-years-old female patient received of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0191), via an intramuscular route on 21Jun2021 (at the age of 49-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included allergy. Patient allergic to medicines she don't take medicine because she always had a reaction to it like, like Morphine, Oxycodone, Ibuprofen, Tylenol. Patient don't took narcotics. The patient concomitant medications included cetirizine hydrochloride (ZYRTEC) tablet with dose 10 mg for allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jun2021 (5 minutes after vaccination), the patient experienced felt her legs like swelling that they just felt weird and within that 15 minutes after having the shot leg down and her legs, she had raised rash and both of them on both legs and they were red like red and so then, She had scratchy redness on my arms it's a reaction that she get when she take medicines and she had allergic reaction to them. Patient stated that wanted to have check up she had it last week. It's just the Blood test standard blood panel like CBC all the things just the mix of Cholesterol all that, Annual Blood work and said Yes everything was good. Patient took Diphenhydramine HCL (BENADRYL) tablet 25 mg as treatment. About 25 minutes after she got with the Pharmacist and he finally can get a thing It was about 25 minutes after the shot is when she got the Benadryl and it took about 30 minutes from the Benadryl 20-30 minutes that the redness is at least went down, she still had the raised rash but her legs were not red like red they were and now she was at home and it's pretty much subsided the reaction, she don't have the scratchiness and stuff she had few little spots here and there but not anything. The outcome of the events was recovering.  Time (24hr) of vaccination: Consumer stated, "My appointment was at 2:30 but I think it was about 2:35 time I got it I don't know about 2:35, 2:40 something central time."  Additional information has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Peripheral swelling, Urticaria
Clinical narrative: I felt my legs like swelling; I had raised rash and both of them on both legs; they were red/I had scratchy redness on my arms; I had scratchy redness on my arms; raised rash; they just felt weird; This is a spontaneous report from a contactable consumer (patient).   A 49-years-old female patient received of BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Lot Number: EW0191), via an intramuscular route on 21Jun2021 (at the age of 49-years) as dose 1, single in the left arm for covid-19 immunisation. The patient medical history included allergy. Patient allergic to medicines she don't take medicine because she always had a reaction to it like, like Morphine, Oxycodone, Ibuprofen, Tylenol. Patient don't took narcotics. The patient concomitant medications included cetirizine hydrochloride (ZYRTEC) tablet with dose 10 mg for allergy. The patient did not receive any other vaccines within four weeks prior to the vaccination. On 21Jun2021 (5 minutes after vaccination), the patient experienced felt her legs like swelling that they just felt weird and within that 15 minutes after having the shot leg down and her legs, she had raised rash and both of them on both legs and they were red like red and so then, She had scratchy redness on my arms it's a reaction that she get when she take medicines and she had allergic reaction to them. Patient stated that wanted to have check up she had it last week. It's just the Blood test standard blood panel like CBC all the things just the mix of Cholesterol all that, Annual Blood work and said Yes everything was good. Patient took Diphenhydramine HCL (BENADRYL) tablet 25 mg as treatment. About 25 minutes after she got with the Pharmacist and he finally can get a thing It was about 25 minutes after the shot is when she got the Benadryl and it took about 30 minutes from the Benadryl 20-30 minutes that the redness is at least went down, she still had the raised rash but her legs were not red like red they were and now she was at home and it's pretty much subsided the reaction, she don't have the scratchiness and stuff she had few little spots here and there but not anything. The outcome of the events was recovering.  Time (24hr) of vaccination: Consumer stated, "My appointment was at 2:30 but I think it was about 2:35 time I got it I don't know about 2:35, 2:40 something central time."  Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Immobile, Mobility decreased, Pain in extremity, Shoulder injury related to vaccine administration
Clinical narrative: has no mobility; the injection was given incorrectly; experiencing severe pain in arm; her shoulder started hurting; has sirva; she has no mobility in the arm; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, administered in left arm on 20Mar2021 at 02:15 (age at the vaccination was 63 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included sore arm, flu, shingle and pneumonia; all were from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient was received first dose of BNT162B2 (Expiry Date, NDC number: unknown, Batch/lot number: U6202) in left arm on 27Feb2021 for covid-19 immunisation and no reaction experienced. On 20Mar2021, the patient experienced has no mobility, severe pain in arm was reported as worsened, her shoulder started hurting and has sirva (shoulder injury related to vaccine administration). Additional context was received as, the patient had the second shot on 20MAR2021, a couple hours after, patient started experiencing a severe pain in her arm, and patient figured it was a reaction from the shot, but it continued for way beyond normal recommendation, and patient shoulder started hurting, patient has no mobility, and patient son is a physician, and he examined patient and said patient had sirva, patient looked it up and it's exactly what patient has, the injection was given incorrectly, now has a problem with her shoulder. The patient was talking to her son, the pain was really bad, and patient has no mobility in the arm, she can only raise it so high, and patient spoke to her son yesterday, who gave her a check up and said a lot of times if injections are injected wrong, it goes into the shoulder capsule rather than deltoid muscle, and patient has all the symptoms of it, it's very painful, she can't do what she can do with the other arm, with the left arm, and she has had injections before, the flu, the first COVID, the pneumonia, the shingles, and that is usually just a sore arm and everything, but this is a problem. The patient thought it would go away, then a week went by, then another week went by, and therapeutic measures were taken as a result of pain in arm, shoulder pain, shoulder injury related to vaccine administration and took Advil (expiry is OCT 2022, lot: DF0846, they are 350 coated tablets and 200mg), patient would take two and it wouldn't do anything, and she has a high tolerance of pain, and it's getting worse. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior was none. Outcome of the events was not recovered.  Additional Information has been requested. Further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong technique in product usage process
Clinical narrative: has no mobility; the injection was given incorrectly; experiencing severe pain in arm; her shoulder started hurting; has sirva; she has no mobility in the arm; This is a spontaneous report from a contactable consumer (patient). A 63-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, Batch/Lot Number: ER8727), via an unspecified route of administration, administered in left arm on 20Mar2021 at 02:15 (age at the vaccination was 63 years) as DOSE 2, SINGLE for covid-19 immunisation. Medical history included sore arm, flu, shingle and pneumonia; all were from an unknown date and unknown if ongoing. Concomitant medications were not reported. The patient was received first dose of BNT162B2 (Expiry Date, NDC number: unknown, Batch/lot number: U6202) in left arm on 27Feb2021 for covid-19 immunisation and no reaction experienced. On 20Mar2021, the patient experienced has no mobility, severe pain in arm was reported as worsened, her shoulder started hurting and has sirva (shoulder injury related to vaccine administration). Additional context was received as, the patient had the second shot on 20MAR2021, a couple hours after, patient started experiencing a severe pain in her arm, and patient figured it was a reaction from the shot, but it continued for way beyond normal recommendation, and patient shoulder started hurting, patient has no mobility, and patient son is a physician, and he examined patient and said patient had sirva, patient looked it up and it's exactly what patient has, the injection was given incorrectly, now has a problem with her shoulder. The patient was talking to her son, the pain was really bad, and patient has no mobility in the arm, she can only raise it so high, and patient spoke to her son yesterday, who gave her a check up and said a lot of times if injections are injected wrong, it goes into the shoulder capsule rather than deltoid muscle, and patient has all the symptoms of it, it's very painful, she can't do what she can do with the other arm, with the left arm, and she has had injections before, the flu, the first COVID, the pneumonia, the shingles, and that is usually just a sore arm and everything, but this is a problem. The patient thought it would go away, then a week went by, then another week went by, and therapeutic measures were taken as a result of pain in arm, shoulder pain, shoulder injury related to vaccine administration and took Advil (expiry is OCT 2022, lot: DF0846, they are 350 coated tablets and 200mg), patient would take two and it wouldn't do anything, and she has a high tolerance of pain, and it's getting worse. Prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior was none. Outcome of the events was not recovered.  Additional Information has been requested. Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 antibody test
Clinical narrative: getting Covid after Covid shots; The patient confirmed that she did have coronavirus after getting both Covid; This is a solicited report from a non-Pfizer sponsored program (marketing program name not available) from a contactable consumer, based on information received by Pfizer (manufacturer control number: US-AMGEN-USASL2021088374). The case was split from master case 2021688566 for a female patient taking BNT162B2 and experienced COVID-19 and Vaccination failure.  A female patient of an unspecified age received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and Expiration date was not reported) via an unspecified route of administration on an unspecified date as dose 1, single, dose 2 via an unspecified route of administration on an unspecified date as dose 2, single for COVID-19 immunization. Medical history included ongoing rheumatoid arthritis current medical condition. Concomitant medication included etanercept (ENBREL) taken for rheumatoid arthritis. The patient experienced getting covid after covid shots, the patient confirmed that she did have coronavirus after getting both covid. This non-serious solicited report (USASL2021088374) was reported to Amgen on 07Jun2021 by a consumer from a commercial program (PSP00180b) and involves a female patient who experienced coronavirus antibodies and results came back positive, [PT: sars-cov-2 antibody test positive] while receiving Enbrel. No historical medical condition was reported. The patient concomitant medications included Covid-19 (corona virus disease-2019) Vaccine. No co-suspect medications were reported. The patient began Enbrel on an unknown date. On an unknown date, the patient stated that she was concerned about Coronavirus and taking Enbrel. On an unknown date, the patient stated that she just went in to give blood at rheumatologist and was checked for coronavirus antibodies and results came back positive. The patient stated that she knows Enbrel would wear down immune system. The patient would like to know, if Enbrel was result of getting Covid after Covid shots. Action taken with Enbrel was reported as unknown for the event sars-cov-2 antibody test positive. The causal relationship between the event sars-cov-2 antibody test positive and Enbrel was not provided by the consumer. The patient underwent lab tests and procedures which included sars-cov-2 antibody test was positive. No treatment information was received. The outcome of events was unknown.   Follow up has been requested.  The reporter's assessment of the causal relationship of the events with the suspect product was not provided at the time of this report. Since no determination has been received, the case is managed based on the company causality assessment.  Causality Assessment: Event SARS-CoV-2 antibody test positive as per Company were assessed to be non-serious and unrelated to etanercept, whereas causality of event Covid after Covid shots was unknown.  No follow-up attempts possible. No further information expected
Age: 1.0
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event, Wrong product administered
Clinical narrative: Pentacel and Acthib on the same day in error due to the wrongfully pulling the ActHib vaccine. with no reported adverse event; Pentacel and Acthib on the same day in error due to the wrongfully pulling the ActHib vaccine. with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from other health care professional via physician. (Reference number- 00647951) and transmitted to Sanofi on 18-Jun-2021.  This case involves a 1 year old female patient administered DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (Lot number: U6899AB and expiry date: 17-amy-2022) and 0.50ml dose of HIB (PRP/T) VACCINE [ACT-HIB] standard once (Lot number: UJ398AAA and expiry date: 06-Aug-2021) via intramuscular route in left thigh for prophylactic vaccination on 18-Jun-2021 on the same day in error due to the wrongfully pulling the ACT-HIB vaccine (wrong product administered and extra dose administered)  Relevant medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MEASLES, MUMPS AND RUBELLA VACCINE) for prophylactic vaccination.  It was a case of an actual medication error due to wrong vaccine administered and extra dose administered (latency same day).  At the time of report, no adverse event was reported.  At the time of reporting, the outcome of both events were unknown.  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 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
Age: 32.0
Sex: M
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: A 32 years old was administered Typhim vaccine that was expired on 31-May-2021 with no reported adverse event; Initial information regarding an unsolicited valid non-serious case was received from a physician via other health care professional via Global Medical Information (GMI) (Reference number- 00650245) and transmitted to Sanofi on 21-Jun-2021.  This case involves a 32 years old male patient was administered 0.5 ml dose of TYPHOID VI POLYSACCHARIDE VACCINE [TYPHIM VI] (lot R2A301M, expiry date: 31-May-2021) via intramuscular route in the left deltoid for prophylactic vaccination on 21-Jun-2021 (Expired product administered)  Medical history, medical treatment(s), vaccination(s) and family history were not provided. The patient had no concomitant medications  It was a case of an actual medication error due to Expired vaccine used (latency same day).  At the time of report, no adverse event was reported.  Medical Assistant stated that an expired Typhim was given to a patient and wanted to find out about the next steps.  At the time of report, the outcome of event was unknown.  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.