chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19, UNK
Symptoms: Rheumatoid arthritis
Clinical narrative: Rheumatoid arthritis flare up; This is a solicited report based on the information received by Pfizer from AbbVie Inc. (Mfr. Control No.: 21K-163-3954437-00) from a contactable consumer (patient).  Solicited report from the USA by a consumer of an adult male with an event of non-serious RHEUMATOID ARTHRITIS FLARE with HUMIRA (ADALIMUMAB). There was no reported medical history. On an unknown date, the patient experienced RHEUMATOID ARTHRITIS FLARE. PFIZER  BIONTECH COVID-19 VACCINE (TOZINAMERAN) was also considered suspect.   A 45-year-old male patient received BNT162B2 (Lot Number unknown), intramuscular on an unknown date at single dose for covid-19 immunisation, adalimumab (HUMIRA), subcutaneous from an unspecified date at unspecified dose with unspecified frequency(Citrate free) for Moderate to severe Rheumatoid arthritis. The patient's medical history was not reported.Concomitant medication included prednisone from Jun2021. The patient experienced rheumatoid arthritis flare up on an unknown date. The action taken in response to the event for adalimumab was unknown. The outcome of the event was recovering.  Causality for HUMIRA(ADALIMUMAB): The reporter's causality for the event of RHEUMATOID ARTHRITIS FLARE with HUMIRA(ADALIMUMAB) was a reasonable possibility.  Causality for PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN): The reporter's causality for the event of RHEUMATOID ARTHRITIS FLARE with PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN) was probable.  No follow-up attempts are needed; information about lot/batch number cannot be obtained; Sender's Comments: Based on the information available, a possible contributory role of the suspect BNT162B2 can be excluded for the reported rheumatoid arthritis flare up. The concomitant suspect product adalimumab might provide an alternative explanation of the reported event.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: I was diagnosed with 2 DVT in my left leg on 19Jun2021; This is a spontaneous report from a contactable consumer (patient). A 29-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration, administered in left arm on 20Apr2021 at 18:00 (at age of 29 years old, Lot Number: EW0161) as a single dose for covid-19 immunization. No known allergies and no other medical history. The patient's concomitant medications were not reported. The patient was diagnosed with 2 DVT in left leg on 17Jun2021 at 21:00. The event resulted in Emergency room/department or urgent care. Treatment received, currently on Blood Thinners. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the event was recovering.
Sex: M
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: blemish blood clot on the leg; This is a spontaneous report from a contactable consumer (patient) reported for himself. A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration on an unspecified date (at unknown age) as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. Caller states that he is calling about the Pfizer Covid vaccine. He has concerns as well as he would like to find out information. After he got the vaccine, he got a blemish blood clot on the leg. Caller states that he was calling Informing that the vaccine produces a mixture of the proteins and not the ones we want. He has a blood clot in the leg but it didn't kill him. Caller states that he would like to finish that the modified messenger produces modified proteins that Pfizer never said anything about. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Rash, Rash pruritic, Vaccination site rash
Clinical narrative: It's so itchy; I had some rash underneath the vaccinated area and on my lower thigh which got worse; I had some rash underneath the vaccinated area and on my lower thigh which got worse; sleepless nights; This is a spontaneous report from a contactable consumer (patient). A non-pregnant 50-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0171), via an unspecified route of administration, administered in Arm Left on 12Jun2021 13:30 (at age of 50 years old) as single dose for COVID-19 immunisation. Medical history was none. The patient's concomitant medications were none. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. No other vaccine in four weeks. No other medications in two weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: EW0180), administered in Arm Left at 50 years old for COVID-19 immunisation with no reaction. Got 2nd dose on the 12Jun2021 and 2 days after (14Jun2021) patient had some rash underneath the vaccinated area and on lower thigh which got worse until few days later. It's so itchy, though patient has been taking anti-allergy (Allegra) and tried over the counter anti-itch lotion, the itch didn't go away. Until today, it's still itchy and it reached down legs now which caused sleepless nights (Jun2021). AE resulted in: Doctor or other healthcare professional office/clinic visit. Treatment received (still have to visit clinic for the itch). The outcome of the events was Not recovered.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: She received the Pfizer COVID-19 Vaccine 1st dose on April 17 since then she had 9 allergic reactions which are severe and she's been back and forth to the emergency; This is a spontaneous report from a Pfizer sponsored program. A non-contactable female consumer (patient) reported that a female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection), via an unspecified route of administration on 17Apr2021 (Batch/Lot number was not reported) as a single dose for covid-19 immunization. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient received the Pfizer COVID-19 Vaccine 1st dose on 17Apr2021 since then she had 9 allergic reactions which are severe and she's been back and forth to the emergency. She had medical bills that reached to thousand dollars and she was asking for compensation and she was also advised not to take the 2nd dose of the Pfizer COVID vaccine. The outcome of the event was not recovered.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Blindness, Hyperhidrosis, Pallor, Tremor
Clinical narrative: temporary loss of vision; sweating; pale skin; shacking; This is a spontaneous report from a non-contactable pharmacist. A 27-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: Unknown), intramuscularly, administered in left deltoid on 20Jun2021 15:00 (at 27-year-old) as dose 1, single, for COVID-19 immunization. The patient had no medical history. No unknown allergy. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medication included cannabis. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 20Jun2021 at 15:00, the patient experienced temporary loss of vision, sweating, pale skin, and shacking. The events resulted in emergency room/department or urgent care. It was unknown whether treatment was received. The outcome of the events was unknown. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible, information about batch/lot number cannot be obtained.; Sender's Comments: Based on the temporal relation, the association between the event blindness and vaccination cannot be completely ruled out.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.
Age: 57.0
Sex: U
Vaccine: COVID19
Symptoms: Dysphagia, Hypersensitivity, Paraesthesia oral, Rash, Swollen tongue
Clinical narrative: allergic reaction; Tingling on tongue and it swells up; Tingling on tongue and it swells up; Hard to swallow; have a rash on my neck, it was on my face and all over up to my chest; This is a spontaneous report from a contactable consumer (patient). A 57-year-old patient of an unspecified gender received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot Number: ER8737), via an unspecified route of administration, administered in Arm Left on 18Jun2021 (at age of 57 years old) as single dose for COVID-19 immunization. Medical history included Discoid lupus erythematosis, Hypothyroidism. Concomitant medications included levothyroxine sodium (SYNTHROID); famotidine (PEPTID); vitamin d [vitamin d nos]; vitamin b nos; calcium; calcium carbonate, sodium fluoride (FLORICAL).  No Prior vaccination (Within 4 weeks). Consumer stated, I got the vaccine on Friday and I had an allergic reaction. I had tingling on my tongue and it swells up and it was hard to swallow and I had to go to the emergency room. Consumer stated, I have a rash on my neck, it was on my face and all over up to my chest. (Not clarified further), All on 18Jun2021 5:30 pm and were medically significant. Treatment for event (went to the ER and they gave Benadryl and Prednisone). Patients outcome of the events was unknown.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Vertigo
Clinical narrative: I was sitting there eating with family and all of a sudden felt like I was going to tip over out of my seat. I lost sense of up and down for approximately 15 seconds.; I have been struck with 3 bouts of what I think are vertigo.; This is a spontaneous report from a contactable consumer or other non hcp (patient). A 35-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), dose 1 at age of 35 years via an unspecified route of administration, administered in Arm Left on 16May2021 09:30 (Lot Number: EW0185) as single dose, dose 2 via an unspecified route of administration, administered in Arm Left at age of 35 years on 06Jun2021 16:30 (Lot Number: EW0217) as single dose for covid-19 immunisation. Medical history included semi-rough bout of covid in early Dec2020. The patient's concomitant medications were none. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No any other medications the patient received within 2 weeks of vaccination. Between the time of the first shot (since May2021) and post-second shot (most recent event was at breakfast on 13Jun2021), patient had been struck with 3 bouts of what he thought was vertigo. Have not had that issue before. Patient didn't have allergies. The worst of them was that morning at breakfast, Patient was sitting there eating with family and all of a sudden felt like he was going to tip over out of my seat. He lost sense of up and down for approximately 15 seconds. Had this happened while he was driving not sure what may have occurred. No treatment received. Since the vaccination, the patient has not been tested for COVID-19. The outcome of the events was recovered in Jun2021.  Information on Lot/Batch number was available. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Electrocardiogram, Tachycardia, Tinnitus
Clinical narrative: Tachycardia; tinnitus in both ears; This is a spontaneous report from a contactable consumer (patient). A 55-year-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number was not reported), via an unspecified route of administration, administered in Arm on 23Mar2021 (reported Age at Vaccination was 55 years old) as single dose for COVID-19 immunization. The patient medical history was not reported. There were no concomitant medications. The patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/lot number: EN6202) on 02Mar2021 (at 55 years old) as single dose for COVID-19 immunisation, No reaction on previous exposure to vaccine. Caller states he is experiencing since 10May2021, tinnitus in both ears, states he found out that it is being reported that people are experiencing this side effect after the Pfizer Covid vaccine so he wants to report it. States he got the first dose of the Pfizer vaccine on 02Mar2021 and second dose on 23Mar2021. States the tinnitus started on 10May2021, states it first got a little better but over the last couple of days it has gotten worse. States when he had the second vaccine, 9 minutes after the second dose he had tachycardia they rushed him to the ED (emergency department) and they kept him there for 2 hours, did an EKG and he seemed to be doing okay, states the next evening it happened again, ambulance came to his home the next evening, had a  rapid heart beat again, took him to the same hospital, the ED and they let him go in a few hours later and it completely resolved and has not happened again. States he got injections in both his left and right arms, does not clarify which injection went in which arm. The patient was hospitalized for Tachycardia on unknown date. Emergency room visit for Tachycardia. The outcome of the event Tachycardia was recovered on 24Mar2021, for other event was not recovered.  information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Gait disturbance, Haemorrhage subcutaneous, Headache, Heart rate irregular
Clinical narrative: Irregular heart beats; I could barely move; exhausted/didn't had any energy/tired; stressed out; Blood spots, just a small section of leg leading to the skin.; Headache; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 24May2021 (Lot Number: EW0168; Expiration Date: 31Aug2021) as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included Pre-diabetic. Concomitant medication(s) included ergocalciferol (VIT D); calcium (CALCIUM).  But she didn't take any when she was taking the vaccine shot like for like a week. The patient experienced headache on 25May2021, she had a headache for two and half weeks continuously then after that for another week later, she had often on and off for another week even then the next week it's still little bit of handle for at least like 5 minutes and hour then but couldn't better but it took her quite a while to get better. Irregular heart beats for 4 days from an unspecified date, her heart was jumping so much, it's kind of get out of her, she thought she was going to die. Because it was so much and she felt so exhausted. She didn't have any energy. She could barely move, this was her heart jumping so much and she was just feel so tired and so stressed out. She started getting some blood spot and leading to the skin, just a small section of her leg on an unspecified date. No treatment received for events. The outcome of events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Stress
Clinical narrative: Irregular heart beats; I could barely move; exhausted/didn't had any energy/tired; stressed out; Blood spots, just a small section of leg leading to the skin.; Headache; This is a spontaneous report from a contactable consumer (patient). This 63-year-old female patient received bnt162b2 (BNT162B2), dose 1 via an unspecified route of administration, administered in left arm on 24May2021 (Lot Number: EW0168; Expiration Date: 31Aug2021) as DOSE 1, SINGLE for COVID-19 immunisation.  Medical history included Pre-diabetic. Concomitant medication(s) included ergocalciferol (VIT D); calcium (CALCIUM).  But she didn't take any when she was taking the vaccine shot like for like a week. The patient experienced headache on 25May2021, she had a headache for two and half weeks continuously then after that for another week later, she had often on and off for another week even then the next week it's still little bit of handle for at least like 5 minutes and hour then but couldn't better but it took her quite a while to get better. Irregular heart beats for 4 days from an unspecified date, her heart was jumping so much, it's kind of get out of her, she thought she was going to die. Because it was so much and she felt so exhausted. She didn't have any energy. She could barely move, this was her heart jumping so much and she was just feel so tired and so stressed out. She started getting some blood spot and leading to the skin, just a small section of her leg on an unspecified date. No treatment received for events. The outcome of events was unknown.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Haemorrhagic stroke, Thrombotic stroke, Visual impairment
Clinical narrative: Two hemorrhagic strokes; Clotting stroke; Experienced vision impairment in one eye; This is a spontaneous report from a non-contactable consumer. This non-contactable consumer reported for an adult female patient received bnt162b2 (PFIZER COVID-19 VACCINE), via an unspecified route of administration in 2021 (Batch/Lot number was not reported) as single dose for COVID-19 immunisation; eptacog alfa (activated) (NOVOSEVEN RT), intravenous from an unspecified date (Batch/Lot number was not reported) at unspecified dose for factor VII deficiency. Medical history included ongoing factor VII deficiency. The concomitant medications were not reported. In 2021, the patient receiving therapy with NOVOSEVEN RT stated that she was advised to get the NOVOSEVEN RT infusion 48 hours prior to getting the PFIZER COVID-19 vaccine. The patient waited for 15 min after getting the COVID-19 vaccine for observation and was fine. However, as soon as the patient left she experienced two hemorrhagic strokes and one clotting stroke. The patient was hospitalized for the events. The patient experienced vision impairment in one eye due to the events. The action taken in response to the events for NOVOSEVEN RT was unknown. The outcome of the events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for COVID; tested positive for COVID; This is a spontaneous report from a contactable consumer. This consumer (patient) of unspecified age and gender received bnt162b2 (BNT162B2), dose 2 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose, dose 1 via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as single dose for COVID-19 immunisation. Medical history included tested positive for COVID twice over six months and immunodeficiency. The concomitant medications included corticosteroids. The patient tested positive for COVID twice over six months and the second time was more than a month after two Pfizer vaccines. The patient do take corticosteroids so am immunocompromised. The outcome of the event was unknown..   Information on the lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Hallucination
Clinical narrative: Hallucinations: they happen sometimes, not all the time, and only when he is anxious, after first vaccine.; when his anxiety is high; This is a spontaneous report from a contactable consumer (patient himself). A 51-year-old male patient received BNT162b2 (PFIZER BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Lot number- EW0187) via an unspecified route of administration in right upper arm (as reported) on 20Jun2021 10:35 as dose 1, single (at the age of 51-years-old) for COVID-19 immunization.  Vaccination Facility Type was reported as pharmacy. Vaccine was not administered at Military Facility. Patient medical history included ongoing high blood pressure from about 20 years ago, ongoing depression from 1996, ongoing anxiety from 1996, ongoing obsessive-compulsive disorder from about 3.5 years ago. The concomitant medications included ongoing citalopram oral tablet at a dose of 40 mg from 1996 taken for antidepressant therapy, ongoing trifluoperazine oral tablet at a dose of 5 mg from 1996 taken for antipsychotic therapy, ongoing clonezapan oral tablet at a dose of 0.5 mg taken for anxiety, started about 5 years ago, ongoing lisinopril oral tablet taken for high blood pressure started about 15 years ago. On an unspecified date in Jun2021, patient stated his hallucinations began after the vaccine, stated they happened sometimes, not all the time, and only when he was anxious after 1st vaccine. Patient stated the hallucinations were somewhat better. The adverse events did not result in physician office visit or emergency room visit. The outcome of the events was recovering.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Crohn's disease
Clinical narrative: crohn's flare up and was out of work for a month; Joint pain; This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for Injection, Batch/Lot Number: EP6955; Expiration Date: 30Jun2021), via an unspecified route of administration on 24Mar2021 (at the age of 54-years-old) as dose 1, single for COVID-19 immunization. The patient medical history included crohn's disease (diagnosed over 20 years ago), acid reflux (esophageal). The patient concomitant medications included mesalazine (LIALDA) (MANUFACTURER UNKNOWN), via an unspecified route of administration at unspecified date at 1.2 g, daily (per day) for crohn's disease; omeprazole (PRILOSEC) (MANUFACTURER UNKNOWN), via an unspecified route of administration at unspecified date at 20 mg, once a day for acid reflux (esophageal). On an unspecified date, the patient experienced crohn's flare up and was out of work for a month, joint pain. The patient is calling about the covid vaccine. The patient was weaning off some of the medications with the doctor permission, Lialda. The patient can't remember when symptoms started to return but it closely corresponded with when the patient was vaccinated. The patient had a Crohn's flare up and was out of work for a month. Lialda lot, NDC, and expiration date not probed as it is not a Pfizer product. The patient has been seeing his GI doctor for the treatment of his flare up. The patient is getting close to getting his Crohn's back into remission, his blood work yesterday showed that it is almost there. Event: The patient is unsure when the symptoms started coming on. The joint pain started right around the first dose and then he got the second shot in the middle of April. The symptoms were getting increasingly worse at the end of May and then the middle of May is when they started changing up the mediations. The patient also had blood work on 27May2021. The clinical outcome of the joint pain was unknown and crohn's flare up and was out of work for a month was recovering.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site haemorrhage
Clinical narrative: lost a lot of blood, there was excess bleeding at the injection site; This is a spontaneous report from a contactable consumer (wife). A 73-year-old male patient (husband) received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: E19126, Expiration date: unknown) via an unspecified route of administration on 23Jan2021 (at the age of 73-year-old) as dose 2, single for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 23Jan2021, patient experienced lost a lot of blood, there was excess bleeding at the injection site. Reporter called for her husband reporting on the Covid 19 vaccine and who wants to know if he should get a third dose of the vaccine. Reported that when he received the 2nd dose the patient lost a lot of blood, there was excess bleeding at the injection site. Because of this, she was questioning if he needs a third dose. Reporter stated that the tech put the needle in and afterward states that he was the 3rd patient that had blood spew out of the injection site. No other information provided for this statement as the reporter declined to complete the report. It was explained the bleeding lasted about an hour, it was not a lot but shot right out of the puncture, where the jab was at the injection site. There was no investigation assessment provided. The outcome of event was recovered on 23Jan2021.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood iron, Blood iron decreased
Clinical narrative: Patient got a blood transfusion on 17May2021 due to low iron.; This is a spontaneous report from a contactable pharmacist. A 56-year-old female patient received first dose of BNT162B2 (Pfizer-biontech covid-19 vaccine, Solution for Injection), via an unspecified route on an unknown date as a dose 1 single for covid-19 immunization. The patient medical history and concomitant medications were not reported. Patient got a blood transfusion on 17MAY2021 due to low iron. Patient wanted to know if there will be a potential contraindication for a blood transfusion patient to get the 2nd dose of the BNT162B2 (Pfizer BioNTech Covid-19 Vaccine). Patient underwent for lab test and procedure which included iron test result was low. The clinical outcome of the event was unknown. Information on the lot/batch number has been requested. Follow-up attempts not completed; information about lot/batch number cannot be obtained. No further information expected. ; Sender's Comments: Based on current information available, the event low iron mostly represented intercurrent condition in this patient with advanced age, unrelated to Bnt162b2. Relevant medical history and concurrent disease are missing for a medically meaningful assessment.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RAs, Ethics Committees, and Investigators, as appropriate
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Cough, Diarrhoea, Hyperpyrexia
Clinical narrative: it was 106 fever; She is just very sick; Cough; Nausea; I vomited twice; Diarrhea; Muscle pain; Weakness; cold; she was not well; This is a spontaneous report from contactable consumer (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) via unknown route of administration on 23Jun2021 as dose 2 single for COVID-19 immunization. Medical history and Concomitant medications were not reported. It was reported that patient was very sick now. She had the second Pfizer, she had bad reaction. It was 106 fever all night and she was not well. Patient was vomiting a lot yesterday when she came back and since then fever went up till 104 and she was taking Tylenol to put her cold down. Patient turned to develop the symptoms. patient had cough, fever, nausea, vomited twice, diarrhoea, muscle pain everywhere, had weakness all in 2021 and then you know by the time I am going to bed the fever was 102.7 so I took Tylenol and then I kept checking my temperature. The outcome of events was unknown.   Information about batch/lot number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise, Myalgia, Nasopharyngitis, Nausea
Clinical narrative: it was 106 fever; She is just very sick; Cough; Nausea; I vomited twice; Diarrhea; Muscle pain; Weakness; cold; she was not well; This is a spontaneous report from contactable consumer (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) via unknown route of administration on 23Jun2021 as dose 2 single for COVID-19 immunization. Medical history and Concomitant medications were not reported. It was reported that patient was very sick now. She had the second Pfizer, she had bad reaction. It was 106 fever all night and she was not well. Patient was vomiting a lot yesterday when she came back and since then fever went up till 104 and she was taking Tylenol to put her cold down. Patient turned to develop the symptoms. patient had cough, fever, nausea, vomited twice, diarrhoea, muscle pain everywhere, had weakness all in 2021 and then you know by the time I am going to bed the fever was 102.7 so I took Tylenol and then I kept checking my temperature. The outcome of events was unknown.   Information about batch/lot number has been requested
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: it was 106 fever; She is just very sick; Cough; Nausea; I vomited twice; Diarrhea; Muscle pain; Weakness; cold; she was not well; This is a spontaneous report from contactable consumer (patient). A 53-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-119 VACCINE, Solution for injection) via unknown route of administration on 23Jun2021 as dose 2 single for COVID-19 immunization. Medical history and Concomitant medications were not reported. It was reported that patient was very sick now. She had the second Pfizer, she had bad reaction. It was 106 fever all night and she was not well. Patient was vomiting a lot yesterday when she came back and since then fever went up till 104 and she was taking Tylenol to put her cold down. Patient turned to develop the symptoms. patient had cough, fever, nausea, vomited twice, diarrhoea, muscle pain everywhere, had weakness all in 2021 and then you know by the time I am going to bed the fever was 102.7 so I took Tylenol and then I kept checking my temperature. The outcome of events was unknown.   Information about batch/lot number has been requested
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Inappropriate schedule of product administration
Clinical narrative: the patient got COVID and didn't got the second dose. The patient went back on 06Jun and got another dose.; Had her first dose 29Dec2020 and a week or two later got Covid; Had her first dose 29Dec2020 and a week or two later got Covid; This is a spontaneous report from a contactable pharmacist. An unspecified age female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 29Dec2020 as single dose for COVID-19 immunization. Medical history and concomitant medication were not reported. The patient had her first does on 29Dec2020 and a week or two later got COVID and didn't got the second dose. The patient went back on 06Jun2021 and received another dose of BNT162B2 via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The reporter stated: the patient was here in currently day to got the second dose from the Jun2021 series. And the reporter wanted to known whether that dose could be given. The outcome of COVID and drug ineffective was recovered in 2021 and the outcome of inappropriate schedule of vaccine administration was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: As there is limited information in the case provided, the causal association between the events drug ineffective, COVID-19 and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Cardiac flutter, Fatigue, Headache, Nausea
Clinical narrative: Heart fluttering; Severe headache neck pain shoulder pain jaw pain; Severe headache neck pain shoulder pain jaw pain; Severe headache neck pain shoulder pain jaw pain/Joint pain; Severe headache neck pain shoulder pain jaw pain; Teeth pain tingling in left fingers; Teeth pain tingling in left fingers; Fatigue; lot of pain; Nausea; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. No concomitant medications were reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization and experienced no events. On an unspecified date after second COVID vaccine, the patient experienced heart fluttering, severe headache, neck pain, shoulder pain, jaw pain, teeth pain, tingling in left fingers, joint pain, fatigue and nausea. Patient reported that it was the first day and patient felt well enough to do anything after receiving the vaccination. Patient had a lot of pain with the vaccine. Events took place after use of product. The clinical outcome of the events was reported as unknown.   Information on the Batch/lot number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Neck pain, Pain, Pain in jaw, Paraesthesia, Toothache
Clinical narrative: Heart fluttering; Severe headache neck pain shoulder pain jaw pain; Severe headache neck pain shoulder pain jaw pain; Severe headache neck pain shoulder pain jaw pain/Joint pain; Severe headache neck pain shoulder pain jaw pain; Teeth pain tingling in left fingers; Teeth pain tingling in left fingers; Fatigue; lot of pain; Nausea; This is a spontaneous report from a contactable consumer (patient). A patient of an unspecified age and gender received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unspecified date as DOSE 2, SINGLE for COVID-19 immunization. Medical history included rheumatoid arthritis from an unknown date and unknown if ongoing. No concomitant medications were reported. Patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Batch/Lot number unknown), via an unspecified route of administration on an unspecified date as DOSE 1, SINGLE for COVID-19 immunization and experienced no events. On an unspecified date after second COVID vaccine, the patient experienced heart fluttering, severe headache, neck pain, shoulder pain, jaw pain, teeth pain, tingling in left fingers, joint pain, fatigue and nausea. Patient reported that it was the first day and patient felt well enough to do anything after receiving the vaccination. Patient had a lot of pain with the vaccine. Events took place after use of product. The clinical outcome of the events was reported as unknown.   Information on the Batch/lot number has been requested.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Crohn's disease
Clinical narrative: Crohn's flare including severe bloating and constipation; This is a spontaneous report from a contactable consumer(patient). A 39-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19  VACCINE, Solution for injection; lot number: EW0177 and expiration date: not reported), via an unspecified route of administration, on Left Arm, on 03Jun2021 at 11:00 (at the age of 39-year-old), as DOSE NUMBER UNKNOWN, SINGLE for covid-19 immunization at Pharmacy or Drug Store. Medical history included ongoing Crohn's disease. No past drug event has been reported. Concomitant medication included hydrochlorothiazide. The patient was not pregnant at the time of vaccination. Patient doesn't have any allergies. Prior to vaccination, the patient was not diagnosed with COVID-19 and after the vaccination patient has not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. On 13Jun2021 (10 days post vaccine), the patient experienced Crohn's flare including severe bloating and constipation and lasted for approximately 2 weeks. The outcome of the events was recovered on Jun2021.
Sex: M
Vaccine: FLU3, UNK, VARZOS
Symptoms: Disability, Gait disturbance, Walking aid user
Clinical narrative: can not walk yet without walker; Initial information was received on 21-Jun-2021 regarding an unsolicited valid serious case from a consumer or non-healthcare professional. This case involves an elderly male patient who can not walk yet without walker (gait inability) after he received FLUVIRIN [INFLUENZA VACCINE INACT SAG 3V], ZOSTAVAX and INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect ZOSTAVAX not produced by Sanofi Pasteur [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient received a dose of suspect FLUVIRIN [INFLUENZA VACCINE INACT SAG 3V] not produced by Sanofi Pasteur [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a serious cannot walk yet without walker (gait inability) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, ZOSTAVAX and FLUVIRIN [INFLUENZA VACCINE INACT SAG 3V]. This event was assessed as medically significant and was leading to disability.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment for the events.  At the time of reporting, the event outcome was unknown.  Information on batch number is requested.; Sender's Comments: This case involves an elderly male patient who experienced gait inability (unknown latency) after vaccination with FLUZONE HIGH DOSE, ZOSTAVAX (not produced by Sanofi Pasteur) and FLUVIRIN (not produced by Sanofi Pasteur). The time to onset was unknown. Further information regarding concurrent condition during vaccination, previous vaccination and tolerance, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of the suspect vaccines cannot be assessed.
Sex: M
Vaccine: HIBV
Symptoms: Vaccination complication
Clinical narrative: Slight reaction to type HIB vaccine just a mild one; Initial information was received on 25-Jun-2021 regarding an unsolicited valid non-serious case received from a patient.  This case involves a male patient (unknown age) who experienced slight reaction to type HIB vaccine just a mild one (vaccination complication) while receiving vaccine HIB (PRP/T) VACCINE [ACT-HIB].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided   On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE [lot number not reported, and expiry date not provided] via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious slight reaction to type HIB vaccine just a mild one (vaccination complication) (unknown latency) following the administration of HIB (PRP/T) VACCINE.  The reporter wants to know that if he can get the Pfizer vaccine and if any common ingredients with type B HIB vaccine. It is unknown if patient's physician provided consent to be contacted.  It was unknown if the patient experienced any additional symptoms/events.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: MMR, MMRV, VARCEL
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No additional adverse events reported; the student had received MMRV/PROQUAD; the student is missing their MMR; This spontaneous report was received from a nurse referring to her student of unknown age and gender. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On 18-SEP-2008, the patient was vaccinated with the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # reported as 0392X but upon internal validation established as  660654/0392X, expiration date was reported as unknown, but upon internal validation established as  05-MAR-2010, 0.5 milliliter) subcutaneously for prophylaxis.    The patient was missing the measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (0.5 ml, subcutaneous; strength, lot# and expiration date were not reported) vaccine on the document (product dose omission issue). It was reported that the dose of varicella virus vaccine live (oka/merck)(VARIVAX) should have been received with the vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) on the same date. It was unknown if documented incorrectly and the patient had received measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) or measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (strength, dose, route, lot# and expiration date were not reported) (wrong product administered). No additional adverse events were reported.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Poor quality product administered, Product container seal issue
Clinical narrative: multiple doses of ROTATEQ had partially sealed foil pouches/ 1 dose of ROT ATEQ that experienced PQC was administered to a patient on 18JUN2021; No additional information provided; 1 dose of ROT ATEQ that experienced PQC was administered to a patient on 18JUN2021; This spontaneous report was received from a nurse referring to a 4-month old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/allergies were not reported.  On unknown dates, it was noticed that multiple doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) had partially sealed foil pouches. There were 19 doses of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# T033634, expiration date 16-MAR-2022) were affected.  On 18-JUN-2021, one dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot# T033634, expiration date 16-MAR-2022, 1 dosage form; strength and dose detail were not reported) that experienced product quality complaint was administered to the patient orally as routine vaccination (product container seal issue and poor quality product administered). No additional information was reported. The product was available for return.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; VARlVAX that underwent a temperature excursion was administered; This spontaneous report as received from a pharmacist and refers to a patient of unknown age and gender. There was no information about the patients concurrent conditions, concomitant therapies or medical history provided.  On 23-JUN-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # T035400, was confirmed to be valid, expiration date 16-OCT-2022 (strength, exact dose, route of administration and anatomical location were not reported). There was no adverse effect reported. Administered dose of vaccine was stored in 42.9 degrees Fahrenheit for 216h. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: I got both my shingles shots / I've had horrible pain in my arm / My arm hasn't been the same since; This case was reported by a consumer via media and described the occurrence of pain in arm in a 50-year-old patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.   Additional details were reported as follows: This case was reported by the patient. The patient received 1st dose of Shingles vaccine and experienced horrible pain in arm. This case has been linked with US2021AMR140659,reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR140659:
Sex: M
Vaccine: COVID19
Symptoms: Chills, Dyspnoea, Sensory loss
Clinical narrative: SHORTNESS OF BREATHE; LOSS OF SENSATION LEFT SIDE; STRONG SHIVER; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 203A21A, and expiry: UNKNOWN) dose was not reported, administered on 24-MAY-2021 for prophylactic vaccination. No concomitant medications were reported.  On 24-MAY-2021, the subject experienced strong shiver. On 28-JUN-2021, the subject experienced shortness of breathe. On 28-JUN-2021, the subject experienced loss of sensation left side. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from strong shiver, and was recovering from shortness of breathe, and loss of sensation left side. This report was non-serious.; Sender's Comments: V0. Medical assessment comment not required as per standard procedure as the case was assessed as non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Disorientation, Dizziness, Dyspnoea, Headache, Vision blurred
Clinical narrative: DIZZINESS/LIGHT HEADEDNESS; BLURRY VISION; DIFFICULTY BREATHING; DISORIENTATION; HEADACHE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 30-JUN-2021 15:35 for prophylactic vaccination. The batch number is unknown and has been requested. No concomitant medications were reported. On an unspecified date, the subject experienced dizziness/light headedness, blurry vision, difficulty breathing, disorientation, and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the dizziness/light headedness, blurry vision, difficulty breathing, headache and disorientation was not reported. This report was non-serious.