chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: swollen lymph nodes; This is a spontaneous report from a contactable consumer (patient). 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 as 2nd dose, single for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2, on an unknow date for covid-19 immunisation. On an unspecified date, the patient experienced swollen lymph nodes, which was generally resolved within 10 days, and likely to have resulted from a robust vaccine-elicited immune response. Outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Product administered at inappropriate site, Vaccination site induration, Vaccination site swelling
Clinical narrative: there was a bump and bubble on his arm and it started to get hard; there was a bump and bubble on his arm and it started to get hard; the needle bent/it went into the fat of the arm and not the muscle; This is a spontaneous report from a contactable consumer (patient) and a non-contactable consumer (patient's girlfriend).   A 29-years-old male patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration on arm on 27May2021 as second dose, single for COVID-19 immunisation (at the age of 29-year-old). The patient medical history and concomitant medications were not reported. Previous, patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot number and expiration was not reported), via an unspecified route of administration on unspecified date as first dose, single for COVID-19 immunisation. The patient was a 29-year-old male patient who received his second dose of the Pfizer BioNTech COVID-19 vaccine on 27May2021 at a vaccination site and when he was being administered the Pfizer BioNTech COVID-19 vaccine, the needle bent. The nurse and pharmacist both said it was ok and that it went into the fat of the arm and not the muscle (start date: 27May2021). The patient also mentioned that there was a bump and bubble on his arm, and it started to get hard (start date: 27May2021). Patient would like to know if there was any guidance about what he experienced, if he received the right dose and if it will affect the efficacy. The outcome for all the events was unknown.  Information on the lot/batch number has been requested.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Muscle swelling
Clinical narrative: ankle was swollen; muscle being swollen; This is a spontaneous report from a contactable consumer (patient). A 64-years-old male patient received first dose of bnt162b2 (BNT162B2 PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on an unspecified date as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient medical history and concomitant medications was not reported. The patient 4 days later he experienced ankle was swollen, He had a walk on the park and he had felt his muscle being swollen too on an unspecified date. He mentioned that he was afraid that side effects after his 2nd dose would be much worse. In line with this, he would like to know if he needs to reschedule his second dose following the side effects he experienced. Response received as Spoke from FAQ-COVID-19 Vaccine-receiving second dose after side effect from first dose (v1.0). As noted in the Fact Sheet for Recipients, you should not get the Pfizer-BioNTech COVID-19 Vaccine if you had a severe allergic reaction after a previous dose of the vaccine or if you had a severe allergic reaction to any ingredient of the vaccine. The decision to receive the second dose for any other reason cannot be made by Pfizer. We refer you to speak to your healthcare provider about the risks of the vaccine compared to the risks of potentially not being fully protected against COVID-19 infection. Your healthcare provider knows your health situation and has access to information that can better help inform this decision. He also wanted to know How long side effects last final (v3.0) for the following points, Side effects that have been reported with the Pfizer-BioNTech COVID-19 Vaccine include: muscle pain, joint pain. The Centers for Disease Control and Prevention (CDC) provides information regarding "Possible Side Effects After Getting a COVID-19 Vaccine". The response below was copied on 23Apr2021. COVID-19 vaccination will help protect you from getting COVID-19. You may have some side effects, which are normal signs that your body is building protection. These side effects may affect your ability to do daily activities, but they should go away in a few days. Some people have no side effects. 3 If you received a second shot Side effects after your second shot may be more intense than the ones you experienced after your first shot. These side effects are normal signs that your body is building protection and should go away within a few days. Referred to HCP for further clinical recommendations. Also, mentioned that should they decide to re-schedule their 2nd dose, they would need to contact the vaccination center where they had the first dose. The outcome of both event was unknown.  Information on the lot/batch number has been requested.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: a little bit of a sore arm; This is a spontaneous report from a non-contactable consumer or other non HCP. A 13-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection) via an unspecified route of administration on 27May2021 (13-years age at the time of vaccination) as 1ST DOSE, SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. It was reported that, On 27May2021, took Pfizer COVID 19 vaccine about 30 minutes ago. She forgot to ask if she could give her medicine like Tylenol if she started having symptoms like body aches and fever. She was not having any side effects except a little bit of a sore arm. The outcome of event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: sore arm; aching; This is a spontaneous report received from a contactable consumer (patient) via a Pfizer sponsored program. A female patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection) via an unspecified route of administration on 23Apr2021 (Lot Number: ER8736; Expiration Date: 31Jul2021) as first dose, single and then via an unspecified route of administration on 14May2021 (Lot Number: EW0168; Expiration Date: 31Aug2021) as second dose single for COVID-19 immunization. Medical history included ongoing asthma and certain allergies. The patient's concomitant medications was taking medications for asthma. The patient had first dose on 23Apr2021 and second dose on 14May2021 and experienced a sore arm and aching after both doses on an unspecified date in 2021. Stated was taking medications for asthma and certain allergies in between the COVID doses for her pre-existing conditions that started way before having the Pfizer vaccine. It was confirmed she had been taking these medications because of her pre-existing conditions for about 40 years. Stated tomorrow will be two weeks since she got her second shot. The outcome of the events was unknown.  Information on Lot/Batch number was available. Additional information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This is spontaneous report received from a non-contactable other health care professional. A patient of an unspecified age and gender 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 1ST DOSE, SINGLE for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm. Felt like someone punched me pretty hard. That went away after about twenty-four hours. The outcome of events was recovered. Causality: Related  No follow-up attempts are possible; information about lot/batch number cannot be obtained
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chromaturia
Clinical narrative: pampers were grey, like grey pee; This is a spontaneous report from a contactable consumer (patients mother). A 39-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number: EWO171 Expiry date: Unknown), dose 1 via an unspecified route of administration, administered in Arm Right on 25May2021 as 1st dose, single dose for covid-19 immunization. Medical history included quadriplegic cerebral palsy (she was born with this), heart beats fast; she has always had this. Concomitant medications included vitamin c:ascorbic (500); buspirone(200 mg) taken for pain; ibuprofen. The patient experienced pampers were grey, like grey pee on May2021. Caller stated that she was calling about her daughter. Caller confirms she was calling about the Pfizer Covid-19 Vaccine. The day before yesterday, her daughter got the Pfizer vaccine and she had quadriplegic cerebral palsy and did not walk or sit. Caller noticed that her daughter wears pampers and it was grey. It was grey, like pee, or whatever. The Pamper was grey. There was no blood or anything, it was just greyish. States she has nothing else to add to the report and that her daughter just told her, ma, you and people to the bathroom and pee. Adds that she, the caller, took the shot and nothing happened to her and her friends but her daughter said that they were peeing in the bathroom and do not look at their urine to see if it was grey and when it was in the water. It was noticeable because her daughter was in a Pamper, she uses Pampers and not the bathroom. Stated that her daughter had been on these for years. Caller just wants to make sure this was reported, because she was so scared and said maybe people urinate in the bathroom and they do not notice because it goes into the water. The outcome of event was not recovered.   Information on lot/batch number was available. Additional information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a contactable consumer (Patient). A 43-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Formulation: Solution for injection, Lot Number: not reported), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. On an unknown date, the patient experienced sore arm from the vaccine. The outcome of the event sore arm was unknown. Information regarding lot/batch number has been requested.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging, Neck pain, Nerve compression, Nerve injury, Neuralgia
Clinical narrative: Pain neck; Nerve problem in my neck as a result of getting the first COVID-19 Vaccination shot; Nerve in my neck is causing the problem; They have called pinched nerve; I also had that shot and It's inspires a little nerve problem in my neck.; This is a spontaneous report from a contactable consumer or other non hcp(patient himself). A 59-years-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Batch/Lot Number: ER8727; Expiration Date: 31Jul2021) via an unspecified route of administration, administered in left arm on 21Mar2021(not clarified further) as 1ST DOSE, SINGLE for COVID-19 immunization. The patient previously received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, LOT number ER8729, Expiration date: 31Jul2021) in right arm on 11Apr2021 for COVID-19 immunization. The patient's medical history. On 27May2021, it was reported that he was prescribed Gabapentin, 400mg, by mouth 3 times a day .Three days after having the shot, he started having pain in the neck, so upon then he went to his primary care physician, scheduled an MRI as suggested, to see where the pain or what was causing the pain came from and it comes back out, he had a nerve problem in his neck as a result of getting the first COVID-19 Vaccination shot. On 27May2021, it was reported he had little problem in his neck on unspecified date and was called as pinched nerve. He wanted to know if he is the only one experiencing this nerve problem from getting the COVID-19 Vaccination shot. On 27May2021, it was reported that Because when I received this shot after complaint the pain in the neck 2 days after he received the shot and it has not, one away today(27May2021) so as if today(27May2021) when It happened he (word not clear) Primary care to suggest me have a MRI and it administered a little problem in my neck. Reporter seriousness for I also had that shot and Its inspires a little nerve problem in my neck and this is little problem in my neck, They have called pinched nerve: Unspecified. Investigation Assessment: Yes. The patient underwent lab tests and procedures which included magnetic resonance imaging on 05May2021: unknown. The outcome of pain neck , nerve problem in neck as a result of getting the first covid-19 vaccination shot; nerve in my neck is causing the problem, they have called pinched nerve, also had that shot and it's inspires a little nerve problem in my neck was unknown.   Follow-up (27May2021): New information received from contactable consumer(patient himself) which included: Concomitant medication, Investigation and Date of Vaccine: It was the 3rd March, the 03Mar2021, 21 day of the 3rd March 2021 of this year (date is not further clarify, Hence not captured in tab).  No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia, Influenza like illness, Pain in extremity
Clinical narrative: flu-like symptoms; little soreness in her arm; metal taste continued. Caller stated "it was like I ate hot soup".; This is a spontaneous report from a contactable consumer (patient's mother)  A 36-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration as single dose for COVID-19 immunization. The patient medical history was included had a diagnosis of MS (multiple sclerosis) and takes Ocrevus. Concomitant medication of patient included ocrelizumab (Ocrevus). Patient previously received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported) via an unspecified route of administration as single dose for COVID-19 immunization. With the first vaccine she experienced a metal taste in her mouth as soon as she received the vaccine, flu-like symptoms and soreness in her arm. On an unknown date, after second dose of vaccination she experienced a little soreness in her arm and the metal taste continued. Reporter voiced that her daughter had flu-like symptoms with both doses of vaccine. The reporter stated that her HCP was upset that she received the Pfizer Covid-19 vaccine while taking the immunosuppressant. Per reporter her daughter's MD voiced that the vaccines didn't take because her immune system was wiped out. Caller asking if Pfizer has information on individuals with MS or taking immunosuppressants?. At the time of this report event outcome was unknown.   Information on the lot/batch number has been requested
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Eyelid rash, Rash
Clinical narrative: Rash on eyelids and arms after 2nd Pfizer COVID vaccine; Rash on eyelids and arms after 2nd Pfizer COVID vaccine; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer (patient's friend) reported for a 65-year-old-male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported), dose2 via unspecified route of administration, on an unspecified date (at the age of 65-years-old) as single dose for COVID-19 immunization. Patient previously took first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Solution for injection, Lot number: not reported), via unspecified route of administration, on an unspecified date, at a single dose for COVID-19 immunization. The patient's medical history included leukemia as a child and had not had a reaction to a vaccine before. Patient's concomitant medications were not reported. On an unspecified date, the patient experienced rash on eyelids and arms after 2nd Pfizer COVID vaccine. He had been to allergist who provided a steroid cream for arm and said not to put on eyelids. The reporter stated that this occurred close to 3 months ago and still has not resolved. He has a dermatologist appointment on 03Jun2021. The outcome of events was not recovered.  No follow-up attempts are needed; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient was given the second dose of the Pfizer Covid 19 vaccine after two weeks; This is a spontaneous report from a contactable pharmacist. A 53-years-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Formulation: Solution for injection, Lot number was not reported) via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. Previously patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number was not reported) via unspecified date for covid-19 immunization.It was reported that patient was given the second dose of the Pfizer Covid 19 vaccine after two weeks instead of three weeks. It has already been reported via agency, but caller does not have the report number. Patient was concerned about potential harm. The outcome of event was unknown.  Follow up needed, further information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Local reaction, Overdose, Pain in extremity
Clinical narrative: patient was inadverently given 0.6mL of the Pfizer-Biontech Covid19 vaccine, instead of the recommended 0.3mL; the recipients experienced more local reactions with very painful arms being reported; the recipients experienced more local reactions with very painful arms being reported; This is a spontaneous report from a contactable Pharmacist. This pharmacist reported for a 25-year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) dose 1 via unspecified route of administration on unspecified date (Batch/Lot number: Not reported) as single dose for COVID-19 Immunisation. The patient's medical history and concomitant medication was not reported. Patient was inadvertently given 0.6mL of the PFIZER-BIONTECH COVID-19 VACCINE, instead of the recommended 0.3mL the recipients experienced more local reactions with very painful arms being reported. The clinical outcome of the events was unknown.  it was also reported that "If a person is given more than the recommended dose, they should be monitored and treated for any symptoms as required. The second dose of vaccine should still be given as per the recommended schedule "  Information on the lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Diarrhoea
Clinical narrative: diarrhea; chills; cough; This is a spontaneous report received from a contactable consumer. A 58-year-old female patient received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot Number and expiration date: was not reported), via an unspecified route of administration on an unspecified date as 2ND DOSE, single dose for covid-19 immunisation. The patient historical vaccine includes received first dose of BNT162B2, via unspecified route of administration on an unspecified date as single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. It was reported that 3 weeks after getting the vaccine patient experienced diarrhea, chills, cough on an unspecified date. The events were considered as non-serious. It was also stated that patient wanted to know if taking non-steroid shot for cough would have a negative effect after being administered the 2nd shot of Pfizer BioNTech Covid-19 Vaccine, Stated that no information is available specifically for Non-steroidal shots for cough to have a potential interaction with Pfizer BioNTech Covid-19 Vaccine. The outcome of the events was unknown.  Information on the lot/batch number has been requested.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia
Clinical narrative: hands were tingling; her heart was racing; This is a spontaneous report from a contactable consumer (mother). A 42-years-old female patient received first dose of BNT162B2 (COMIRNATY, solution for injection, lot number: unknown), via an unspecified route of administration on an unspecified date as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient experienced tingling in hands and her heart was racing on an unspecified date. Outcome of the events was unknown.   Information on the lot/batch number has been requested.
Age: 57.0
Sex: M
Vaccine: UNK
Symptoms: Lymphadenopathy
Clinical narrative: he was taking psychiatric medications and thought maybe this may have had a reactions with the vaccine and caused the swollen lymph nodes; developed swollen lymph nodes on his neck and his stomach; This is a spontaneous report from a contactable pharmacist (daughter). A 57-years-old male patient received bnt162b2 (BNT162B2), via an unspecified route of administration on an unspecified date (Batch/Lot number was not reported) as UNKNOWN, SINGLE DOSE for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications included psychiatric medications (unspecified). She stated that within 48 hours after having the vaccine he developed swollen lymph nodes on his neck and his stomach. There swollen lymph node are still present which was causing the caller concern. She stated that he was taking psychiatric medications and thought maybe this may have had a reactions with the vaccine and caused the swollen lymph nodes. She stated that he had called a number before reaching Agency that had give her this number to call but she was not sure who she talked to other that that it was a pharmacist. She was requesting any documentations on participants who have had swollen lymph nodes as a adverse effect be emailed to her. Spoked from attached document regarding participants in the clinical trials that experienced lymphadenopathy. Relayed to caller that I was not able to send medical information regarding each individual that experienced the swollen lymph nodes and their other medications or medical history. Stated that currently there has been no known link between psychiatric medication and swollen lymph nodes after the Pfizer COVID 19 vaccine. Referred to HCP regarding side effects for evaluation and treatment. Sharing document via email per caller request. The outcome of the events were unknown  Information on the lot/batch number has been requested
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Blister, Burns second degree, Chills, Cough, Fatigue
Clinical narrative: Tickling in Throat/ My throat is on fire like my brain/ My Throat hurts; Tickling in Throat/ My throat is on fire like my brain/ My Throat hurts; Arm burn blister below injection site, I can't lift my arm, like fishy infection, I can't even lay on that arm; Arm burn blister below injection site, I can't lift my arm, like fishy infection, I can't even lay on that arm; Headache; I am tired; Chills; Cough; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0167), dose 1 via an unspecified route of administration on 22May2021 (at the age of 53-years-old) as a 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included depression and mitral valve prolapse from an unknown date and unknown if ongoing. Patient also stated that she has allergy (unspecified) once in a year. Patient had a plate in neck. Concomitant medication(s) included amitriptyline (AMITRIPTYLINE) 25 mg daily once taken for depression from an unspecified start date and ongoing and sertraline hydrochloride (ZOLOFT) 50 mg taken for depression, start and stop date were not reported. On 23May2021 at 03:00 the patient experienced cough and chills. Patient reported that after my first shot she had like a little tickling in her throat now and then she has an arm blister like below the (injection) site, and she did not know if anybody have that. She cannot lift her arm to do and that gave her headache. Patient was tired and wanted to know if this should last that long and why did she get the burn blister. Patient stated that her throat was on fire like her brain and her throat and headache. She wanted to know if anybody else got burnt blister, an arm blister said which was like fishy infection. She could not even lay on that arm. She had chills, cough 3 o clock in the morning. Patient had visited hospital for blister and now blister disappeared. Patient also stated that she still had headache, tiredness and her throat hurts. As a result of headache, fatigue, chills and cough, patient took paracetamol (Tylenol) and since she did not take it then (today) it gotten worse, and so she would take it now. The outcome of the event burnt blister was resolved and outcome of the events headache, fatigue and throat pain was not resolved. The outcome of all other events was unknown.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain, Throat irritation
Clinical narrative: Tickling in Throat/ My throat is on fire like my brain/ My Throat hurts; Tickling in Throat/ My throat is on fire like my brain/ My Throat hurts; Arm burn blister below injection site, I can't lift my arm, like fishy infection, I can't even lay on that arm; Arm burn blister below injection site, I can't lift my arm, like fishy infection, I can't even lay on that arm; Headache; I am tired; Chills; Cough; This is a spontaneous report from a contactable consumer (patient). A 53-years-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot Number: EW0167), dose 1 via an unspecified route of administration on 22May2021 (at the age of 53-years-old) as a 1ST DOSE, SINGLE DOSE for covid-19 immunisation. Medical history included depression and mitral valve prolapse from an unknown date and unknown if ongoing. Patient also stated that she has allergy (unspecified) once in a year. Patient had a plate in neck. Concomitant medication(s) included amitriptyline (AMITRIPTYLINE) 25 mg daily once taken for depression from an unspecified start date and ongoing and sertraline hydrochloride (ZOLOFT) 50 mg taken for depression, start and stop date were not reported. On 23May2021 at 03:00 the patient experienced cough and chills. Patient reported that after my first shot she had like a little tickling in her throat now and then she has an arm blister like below the (injection) site, and she did not know if anybody have that. She cannot lift her arm to do and that gave her headache. Patient was tired and wanted to know if this should last that long and why did she get the burn blister. Patient stated that her throat was on fire like her brain and her throat and headache. She wanted to know if anybody else got burnt blister, an arm blister said which was like fishy infection. She could not even lay on that arm. She had chills, cough 3 o clock in the morning. Patient had visited hospital for blister and now blister disappeared. Patient also stated that she still had headache, tiredness and her throat hurts. As a result of headache, fatigue, chills and cough, patient took paracetamol (Tylenol) and since she did not take it then (today) it gotten worse, and so she would take it now. The outcome of the event burnt blister was resolved and outcome of the events headache, fatigue and throat pain was not resolved. The outcome of all other events was unknown.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Pericardial effusion, Pericarditis
Clinical narrative: pericarditis; a large pericardial effusion; This is a spontaneous report from a contactable physician. An 18-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), at the age of 18 years old, at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The reporter explained the only probable trigger to the 18-year-old male patient developing pericarditis and a large pericardial effusion was the receipt of the first dose of BNT162B2, 2-3 weeks before the diagnosis. The reporter added he read through the CDC website, about increased cases of myocarditis and pericarditis after getting the second dose of BNT162B2. The reporter asked if the second dose was contraindicated after such adverse reaction to the first dose. The outcome of events 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 of Pericarditis and Pericardial Effusion and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.  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.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: Ever since then he's been having pain on that's developed in the opposite shoulder and but its been a week; This is a spontaneous report from a contactable consumer. A 54-year-old male patient (reporter's husband) received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported), via an unspecified route of administration on 21May2021, as single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously had first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number and Expiration date was not reported) via an unspecified route of administration, on an unknown date for COVID-19 immunization. Reporter stated her husband received the Pfizer second shot Covid 19 immunization on 21May2021 and ever since then he's been having pain on that's developed in the opposite shoulder and but it's been a week, a day and a week after the immunization and they were playing golf today and he was in excruciating a pain and he equivalates it to be broken, like a broken arm but it was his shoulder and we have tried phoning, several different places all they say is if you want Covid vaccine we can help you but they cannot help us with the side effect and so this is extremely alarming to us and we want to know what's going on. Was this something to be concerned about. He was a healthy in shape and a 54 year old man and never had any issues with his shoulder until after the shot and we were just trying to see what was going on. Outcome of the event was reported as not recovered.  Information about batch/lot number has been requested.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Arm pain; This is a spontaneous report from a contactable consumer (patient). A 59-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0167) at health department, via an unspecified route of administration, administered in left arm on 05May2021 at 13:05 (at the age of 59-year-old), as 1st dose, single dose for covid-19 immunisation. Reportedly, patient took second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection, Lot number: EW0185) at health department via an unspecified route of administration, administered in left arm on 26May2021 at 13:05 (at the age of 59-years-old), as single dose for covid-19 immunisation. Patient was right-handed so she had them both in her left arm. Patient did not know a dosage for either dose. Patient thought it was good to have it. The patient medical history was none. The patient did not take any other products. The family medical history relevant to adverse events was none. No other vaccinations received by the patient within four weeks prior to the first administration date of the suspect vaccine. After the first dose of vaccination, the patient experienced arm pain on 05May2021. It started to hurt that evening (05May2021) and lasted probably for four days. The patient stated that with her first dose she had no other side effects. No relevant tests performed. There were no adverse events following prior vaccinations. There were no additional vaccines administered on same date with the Pfizer vaccine considered as suspect. The Patient did not visit emergency room and Physician office as well. No Investigation assessment or relevant tests were performed. This report was not related to a study or programme. The outcome of the event was resolved on an unspecified date in May2021.   Information on Lot/Batch number was available. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: After her first COVID-19 Vaccine, she had a sore left arm; after her first COVID-19 Vaccine, she had a low level headache; This is a spontaneous report received from a contactable consumer or other non hcp (patient herself). A 44-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE solution for injection, Batch/Lot Number: EW0176) via intramuscular route of administration, administered in left arm on 05May2021 as 1st dose, single for covid-19 immunization. The patient's medical history was reported as none and concomitant medications were not reported. On 05May2021 after her first covid-19 vaccine, she had a sore left arm that didn't hurt as much as other vaccines she had received, and a low level headache. The patient did not visited Emergency Room or Physician Office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient took Tylenol 500 mg tablet and was fine afterwards. The patient said she was very happy when she only had a sore arm after her first COVID-19 Vaccine because she always kind of got sick with vaccines .The outcome of the events was recovered on an unspecified date in May2021.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Body mass index, Lymph node pain
Clinical narrative: Painful, swollen lymph nodes on right neck; This is a spontaneous report from a contactable Nurse. This 37-year-old female nurse reported in response to HCP letter sent in a cross-referenced case. A 37-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection, Batch/Lot number: EL1283) via intramuscularly in the arm right on 14Jan2021 14:00 2nd dose, single dose for COVID-19 immunisation. Medical history included obesity BMI:37.4, hypertension taking Norvasc 5mg once daily, depression taking Wellbutrin 150 mg once daily and Xanax 0.25 mg BID, arthritis taking Vol-taren 50 mg BID, anxiety taking Wellbutrin 150 mg once daily and Xanax 0.25 mg BID, breast cancer, sarcoma. All medical history from an unknown date and unknown if ongoing, painful swol-len lymph node in left axilla from 25Dec2020 to 05Jan2021 Time: 14:00, Batch/Lot# and expira-tion date: EL0140, outcome was recovered. Concomitant medication(s) included amlodipine be-silate (NORVASC) taken for hypertension from 05Dec2019 to an unspecified stop date (hyperten-sion (5 mg PO once daily taken at night); bupropion hydrochloride (WELLBUTRIN XL) taken for depression from 03Dec2019 to an unspecified stop date (150 mg PO once daily taken in morn-ing); alprazolam (XANAX) taken for anxiety from 03Dec2019 to an unspecified stop date anxiety (0.25 mg PO BID or as needed, takes one in AM and one PM); diclofenac (VOLTAREN [DICLO-FENAC]) taken for arthritis from 03Dec2019 to an unspecified stop date (50 mg PO BID, takes one in AM and one PM). Historical vaccine includes bnt1622 (Lot Number: EL0140, Time the vac-cination was given: 14:00, arm Left: 1st Dose route of Administration: IM) COVID-19 immunisation. Prior vaccination within 4week and adverse event was none. On 14Jan2021, 14:00 the patient experienced painful swollen lymph node on right neck. Causal Relationship: Is there a reasonable possibility that the event is related to Suspect products: Yes. The clinical outcome of the event was not recovered.  No follow up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Incredible Dizziness; Vertigo; This is a spontaneous report from a contactable consumer reported for self. A patient with unspecified age and gender received first dose of BNT162B2 (Pfizer Covid-19 Vaccine, Batch/lot number: unknown, Expiration date: Unknown), via an unspecified route in the left arm on Monday, 24May2021 at 16:15 as a single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. On 30May2021 today at 13:00, patient experienced various side effects which included incredible dizziness and patient can barely keep eyes open. When paraphrased the concern, patient stated vertigo. It's been 7 days since patient had the first vaccine. Patient wanted to know if it can be a late side effect. It was unknown if the patient received any treatment for the events. The clinical outcome of the events was unknown.  Information on the lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pain, Vaccination site pain
Clinical narrative: Having lot of pain in left arm; Chills; He is been in a lot of pain; This is a spontaneous report received from a contactable consumer (patient's wife). A male patient of an unspecified age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/Lot number was not reported), via an unspecified route of administration in left arm on 29May2021 14:00 as single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced having lot of pain in left arm, he has chills, he is been in a lot of pain on May2021. The clinical outcome of the events was unknown.   Information about lot/batch number cannot be obtained. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia
Clinical narrative: I wake up I have numbness, no circulation  on the bottom of my leg/numbness of the leg; This is a spontaneous report from a contactable 61-years-old female patient who reported for herself that she received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; formulation: Solution for injection; Lot number: EW0182) via an unspecified route of administration on 28May2021 (at the age of 61-years-old) in left arm as 1st dose, single dose for COVID-19 immunization. The patient medical history was none. The patient's concomitant medication included paracetamol (Tylenol 8 hour). On an unspecified date, in the evening around 3 after the vaccine, patient took a Tylenol right after and when she get home, she took a Tylenol again and went to bed everything was fine. On 30May2021, (Its yesterday morning early) and she had vaccine on Friday(28May2021) , when she woke up she had numbness, no circulation on the bottom of my leg. The patient received Motrin as treatment for event. There was no Investigation Assessment. Consumer was informed and provided the number of Medical Information. Second dose was scheduled on 19Jun2021. When probed for still experiencing the problem, Patient stated as Yes but not as much but it was still there. The outcome of event was not recovered.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: ADMINISTRATION ERROR PATIENT UNDER  18 YEARS
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspnoea, Pain in extremity, Palpitations
Clinical narrative: heart palpitation, shortness of breath (did not require hospitalization, pain on right side of chest and arm. Felt like I had to take a deep breath every 15 minutes for about five-seven days. Heart palpitations were mostly on 4/18/21
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Pyrexia, Unresponsive to stimuli
Clinical narrative: Fever, dizziness, labored breathing, shortness of breath, unresponsive
Age: 20.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea
Clinical narrative: Fever, dizziness, labored breathing, shortness of breath, unresponsive
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: ADMIN ERROR PT UNDER 18 YEARS
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, Product administered to patient of inappropriate age, Underdose
Clinical narrative: no adverse event; expired ROTATEQ inadvertently adminsitered to a child; ROTATEQ administered to a child; ROTATEQ 0.5 ml was administered; This spontaneous report was received from an unspecified reporter (provider) referring to a child patient. The patient's pertinent medical history, concomitant therapies, drug reactions/allergies were not reported.  In the morning of 06-MAY-2021, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (0.5 ml, once, lot # 1660666 has been verified to be a valid lot number and expiration date was 22-MAR-2021), taken orally for prophylaxis (expired product administered, inappropriate age at vaccine administration, and underdose). The dose never had a temperature excursion and was supported per the post-expiry memo. No product quality complaints or additional adverse events were reported, and no further information was provided.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; temperature excursion for PROQUAD; This spontaneous report has been received from a medical assistant referring to a 4 years old male patient. The patient's concomitant medications, pertinent medical history, drug reactions or allergies were not reported.  On 25-MAY-2021, the patient was vaccinated with the improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant Human albumin (rHA)) (PROQUAD) (strength, route of administration and anatomical location were not provided; lot # T018275, expiration date reported as 23-NOV-2021) 0.5 ml for prophylaxis (product storage error). The vaccine underwent temperature excursion of max 80 Fahrenheit (F) for total 23 hours. It was reported that there were no previous temperature excursions. The digital data logger was involved in recording excursion details. At the time of report, there was no additional adverse event (AE).
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/ PQC reported atthis time.; Nurse called in to reporta temperature excursion. / Caller reported this patient received ROTATEQ,; This spontaneous report was received from a nurse and refers to a 6-month-old patient of unknown gender. The patient's pertinent medical history, concomitant medication, previous drug reactions, and allergies were not reported.       On 10-MAR-2021, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) (lot number 1742460, which has been verified to be valid, the expiration date was reported and validated as 16-NOV-2021), as prophylaxis (dose, dose number, and route of administration were not provided) (product storage error).  The reporter stated the vaccine was exposed to a temperature between 2 to 8 degrees Celcius (C) (9 degrees C) for a time frame of 0 hours 30 minutes 0 seconds, as recorded by digital data logger in a temperature excursion that took place on 09-MAR-2021. There were no previous temperature excursion and no additional adverse events were reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2105USA007003: US-009507513-2105USA007015:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: no other AE; Patient received doses of GARDASIL 9 outside recommended administration schedule.; This spontaneous report was received from medical assistant concerning a 13 years old patient. No concurrent condition, medical history or concomitant therapy was reported.       On 03-OCT-2019, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (at the dose of 1 injection; lot# T007024, expiration date 23-APR-2022) as prophylaxis. The second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was received on 26-MAY-2021 (at the dose of 1 injection; lot# T007024, expiration date 23-APR-2022) as prophylaxis. The patient received doses of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) outside recommended administration schedule. The interval between the first dose and the second dose was long (inappropriate schedule of product administration). No other adverse event (AE) was reported. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); devicelotnumber: T007024; expirationdate: 23-APR-2022; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet criteria for reportability
Age: 19.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product dose omission issue
Clinical narrative: No additional AE  information reported; a patient was administered the first dose of VARlVAX at 19 years old, but never received the second dose; This spontaneous report was received from a pharmacist referring to a 19 years old female patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.         In approximately 2018 (reported as approximately 2-3 years ago), the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) (0.5 ml; strength, route, anatomical location, lot# and expiration date were not reported) for prophylaxis, but the patient never received the second dose (inappropriate schedule of vaccine administered). The reporter inquired if the patient needed to receive the second dose. No additional adverse event was reported.