chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Peripheral swelling
Clinical narrative: severe pain; Right arm swelling; redness; hand numbness and tingling; hand numbness and tingling; right axillary lymph node enlargement; insomnia due to pain; insomnia due to pain; severe fatigue; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 14Feb2022 04:30 (Lot number: FJ6369) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Arthritis" (unspecified if ongoing); "tachycardia" (unspecified if ongoing); "GERD" (unspecified if ongoing). No known allergies. Concomitant medication(s) included: PROTONIX [OMEPRAZOLE]; PROPRANOLOL; VITAMIN D [COLECALCIFEROL]. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: E43246, Location of injection: Arm Left), administration date: 13Jan2021, when the patient was 48 years old, for Covid-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EH9899, Location of injection: Arm Left), administration date: 23Dec2020, when the patient was 48 years old, for Covid-19 immunization. No other vaccine in four weeks. The following information was reported: PAIN (medically significant) with onset 15Feb2022 07:00, outcome "recovering", described as "severe pain"; PERIPHERAL SWELLING (non-serious) with onset 15Feb2022 07:00, outcome "recovering", described as "Right arm swelling"; ERYTHEMA (non-serious) with onset 15Feb2022 07:00, outcome "recovering", described as "redness"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 15Feb2022 07:00, outcome "recovering" and all described as "hand numbness and tingling"; LYMPHADENOPATHY (non-serious) with onset 15Feb2022 07:00, outcome "recovering", described as "right axillary lymph node enlargement"; INSOMNIA (non-serious), PAIN (non-serious) all with onset 15Feb2022 07:00, outcome "recovering" and all described as "insomnia due to pain"; FATIGUE (non-serious) with onset 15Feb2022 07:00, outcome "recovering", described as "severe fatigue". Due to the events the patient missed 2 days of work so far. No covid prior vaccination. No covid tested post vaccination. Therapeutic measures were taken as a result of pain, peripheral swelling, erythema, hypoaesthesia, paraesthesia, lymphadenopathy, insomnia, pain, fatigue included Tylenol , Ibuprofen, Benadryl ice packs.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on current available information, there is reasonable possibility of causal association between the event pain and the suspect drug BNT162B2
Sex: F
Vaccine: COVID19
Symptoms: Illness, Malaise
Clinical narrative: Not feeling good; Patient is not healthy; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MALAISE (hospitalization), outcome "unknown", described as "Not feeling good"; ILLNESS (non-serious), outcome "unknown", described as "Patient is not healthy". Therapeutic measures were not taken as a result of malaise. Additional information: the reporter (patient's daughter) stated that the doctor cannot give the patient the treatment, the patient was not healthy and she just not feeling good right now.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: received the adult formulation purple cap Pfizer BioNTech Covid-19 vaccine past the 31 days; received the adult formulation purple cap Pfizer BioNTech Covid-19 vaccine past the 31 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 16Feb2022 (Batch/Lot number: unknown, Expiration Date: 14Feb2022) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown" and all described as "received the adult formulation purple cap Pfizer BioNTech Covid-19 vaccine past the 31 days".  Additional information: Caller is in purchasing working for a health care facility calling regarding the adult formulation purple cap Pfizer BioNTech Covid-19 vaccine and the expiration. Caller states that some undiluted vaccine vials were in the fridge past the 31 days which was on 14Feb2022. Caller states the vaccine was accidentally administered to a total of 6 patients, 3 patients on 15Feb2022 and 3 patients on 16Feb2022. Caller states the vaccines were stored undiluted in a refrigerator at around 4 to 5 degrees C. Caller would like some information. Caller states he does not have any additional information as he was only told to obtain this information. Caller states to contact the number (Phone number withheld) at a later time to obtain additional information, which would be the person who will be handling the paperwork. A total of 6 patients have received the adult formulation purple cap Pfizer BioNTech Covid-19 vaccine past the 31 days allowable time in the refrigerator.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Computerised tomogram, Echocardiogram, Investigation, Magnetic resonance imaging head
Clinical narrative: Right thalamic stroke; This is a spontaneous report received from contactable reporter (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03Feb2021 (Lot number: EL3247) at the age of 57 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Heart murmur" (unspecified if ongoing); "Environmental allergies" (unspecified if ongoing); "Allergic to Penicillin" (unspecified if ongoing); "dyslipidemia" (unspecified if ongoing); "hypertension" (unspecified if ongoing); "Bronchial asthma" (unspecified if ongoing); "COVID 19" (unspecified if ongoing), notes: recently recovered. There were no concomitant medications. Vaccination history included: Bnt162b2 (Vaccine Name: First dose, Lot Number / Expiry Date: EL0140/ Unknown , ), administration date: 13Jan2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported: CEREBROVASCULAR ACCIDENT (hospitalization) with onset 11Feb2021, outcome "unknown", described as "Right thalamic stroke". The patient was hospitalized for cerebrovascular accident (start date: 11Feb2021, discharge date: 15Feb2021, hospitalization duration: 5 days). The event "right thalamic stroke" was evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: computerised tomogram: (11Feb2021) unknown result; echocardiogram: (11Feb2021) unknown result; (11Feb2021) unknown result; investigation: (11Feb2021) unknown results; magnetic resonance imaging head: (11Feb2021) unknown result. Therapeutic measures were taken as a result of cerebrovascular accident.  The caller found the note the Cardiologist had written and it said "female with a past medical history of dyslipidemia and hypertension presented with a right thalamic stroke with symptoms of gait instability and slurred speech thought to be related to small vessel disease.  Follow up information has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Herpes zoster, Immune system disorder, Neuralgia
Clinical narrative: Weakened my immune system; Shingles; The nerve pain has been debilitating; The nerve pain has been debilitating; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 46 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNE SYSTEM DISORDER (hospitalization), outcome "unknown", described as "Weakened my immune system"; HERPES ZOSTER (hospitalization), outcome "unknown", described as "Shingles"; NEURALGIA (hospitalization), ASTHENIA (hospitalization), outcome "unknown" and all described as "The nerve pain has been debilitating".  Clinical information: The patient was hospitalized after receiving a Covid vaccine. Patient reported that the vaccine weakened her immune system and she got shingles. Patient was out of medication and taking every other day to save pills until approval. Patient is on Xeljanz XR 11 mg.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: had a stroke from Pfizer's vaccine; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant), outcome "unknown", described as "had a stroke from Pfizer's vaccine". Clinical course: The patient had a stroke because of Pfizer's vaccine. This was the second time he had called. He previously spent 20 minutes giving information before the call was disconnected. Caller was recording this call because he thought Pfizer was hiding something and didn't want people to report this. He was getting really frustrated because he couldn't call and speak to anybody. He was supposed to be sent information and never did. He thought it was a cover up. He thought something was getting covered up. He had a stroke and caller mentioned somebody else had a stroke, but unable to clarify who this person was.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myocarditis
Clinical narrative: She has inflammation around her heart and has been seeing a doctor for about a month now.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient (unknown if pregnant) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant), outcome "not recovered", described as "She has inflammation around her heart and has been seeing a doctor for about a month now.". The event "she has inflammation around her heart and has been seeing a doctor for about a month now." was evaluated at the physician office visit. Therapeutic measures were taken as a result of myocarditis. It was unknown that, if other vaccine received or not in four weeks. It was unknown that, other medications received in two weeks. It was unknown that patient had covid prior vaccination and covid tested post vaccination or not. It was unknown patient had allergies.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Aortic valve incompetence, Cardiac disorder, Pain
Clinical narrative: have my Aortic Valve replaced because of the slush and everything that was brought into my heart and caused my heart to pump like it is not supposed to pump; pain; My heart is not going good today; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 79 year-old female patient received bnt162b2 (BNT162B2), administration date 01Mar2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: AORTIC VALVE INCOMPETENCE (medically significant), outcome "unknown", described as "have my Aortic Valve replaced because of the slush and everything that was brought into my heart and caused my heart to pump like it is not supposed to pump"; PAIN (non-serious), outcome "unknown", described as "pain"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "My heart is not going good today". The events "have my aortic valve replaced because of the slush and everything that was brought into my heart and caused my heart to pump like it is not supposed to pump" and "pain" were evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of aortic valve incompetence. Clinical course: On 01Mar2021, patient received vaccination from Pfizer. It was reported that patient had a really bad reaction to it. It has been a horrific problem. Patient was in so much pain, she didn't know what was going on. Patient went to the doctors and told them what was happening. She had so many doctors. She even had to have her Aortic Valve replaced because of the slush and everything that was brought into the heart and caused the heart to pump like it was not supposed to pump. She had a new Aortic Valve replacement thing. Patient was in so much pain, there wasn't much she could do or say. There was a Dr. (name withheld) that verified or she said that she knew or that it was the Pfizer Vaccine that was causing me the trouble. So they had to send her to a pain solution person to see if they could stop the pain but it was directly into the nerve system. Patient needed to go to the hospital this morning, but now just can't go.  The patient was having difficulty paying her medical bills. Patient had to go to the Emergency Room twice because Pfizer said they were going to help her with that. It was then reported that heart was not going good today, and that she missed visit to the doctor.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, COVID-19, Drug ineffective, Fatigue, Inflammation
Clinical narrative: sore arm; tired; She has been fully vaccinated and boosted/ she was diagnosed with the COVID Omicron variant in Jan2022; She has been fully vaccinated and boosted/ she was diagnosed with the COVID Omicron variant in Jan2022; she's had ongoing inflammation of her hips and shoulders; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jan2022, outcome "unknown" and all described as "She has been fully vaccinated and boosted/ she was diagnosed with the COVID Omicron variant in Jan2022"; INFLAMMATION (non-serious) with onset Jan2022, outcome "not recovered", described as "she's had ongoing inflammation of her hips and shoulders"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "tired". The events "she has been fully vaccinated and boosted/ she was diagnosed with the covid omicron variant in jan2022" and "she's had ongoing inflammation of her hips and shoulders" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) provided the inflammation markers; (14Feb2022) inflammation marker is even more elevated; sars-cov-2 test: (Jan2022) positive. Therapeutic measures were taken as a result of covid-19, inflammation.  Clinical course: Investigations: states they did quite a bit of bloodwork which provided the inflammation markers and did more blood work this past Monday and the inflammation marker is even more elevated from the last blood work and they decided to put her back on Prednisone and mild pain medication. States that they put her on the medication on Wednesday and she is feeling relief with the prednisone he would think is what is giving the relief. Caller states if it's not authorized his question is it legal for her to get the 2nd booster shot or anything to stop her from getting the 2nd booster and could her doctor order a 2nd booster and she could get it.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: sore arm; tired; She has been fully vaccinated and boosted/ she was diagnosed with the COVID Omicron variant in Jan2022; She has been fully vaccinated and boosted/ she was diagnosed with the COVID Omicron variant in Jan2022; she's had ongoing inflammation of her hips and shoulders; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program.  A 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset Jan2022, outcome "unknown" and all described as "She has been fully vaccinated and boosted/ she was diagnosed with the COVID Omicron variant in Jan2022"; INFLAMMATION (non-serious) with onset Jan2022, outcome "not recovered", described as "she's had ongoing inflammation of her hips and shoulders"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm"; FATIGUE (non-serious), outcome "unknown", described as "tired". The events "she has been fully vaccinated and boosted/ she was diagnosed with the covid omicron variant in jan2022" and "she's had ongoing inflammation of her hips and shoulders" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: (unspecified date) provided the inflammation markers; (14Feb2022) inflammation marker is even more elevated; sars-cov-2 test: (Jan2022) positive. Therapeutic measures were taken as a result of covid-19, inflammation.  Clinical course: Investigations: states they did quite a bit of bloodwork which provided the inflammation markers and did more blood work this past Monday and the inflammation marker is even more elevated from the last blood work and they decided to put her back on Prednisone and mild pain medication. States that they put her on the medication on Wednesday and she is feeling relief with the prednisone he would think is what is giving the relief. Caller states if it's not authorized his question is it legal for her to get the 2nd booster shot or anything to stop her from getting the 2nd booster and could her doctor order a 2nd booster and she could get it.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Headache, Occipital neuralgia, SARS-CoV-2 test, Trigeminal neuralgia
Clinical narrative: Continual 24/7 head pain; neuralgia in occipital and trigeminal areas of the head.; neuralgia in occipital and trigeminal areas of the head.  Debilitating.; Debilitating.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Apr2021 11:45 (Lot number: EW0164) at the age of 59 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Diabetes" (unspecified if ongoing); "Pulmonary Embolisms" (unspecified if ongoing); "pneumonia" (unspecified if ongoing); "Known allergies: Mushrooms" (unspecified if ongoing), notes: Known allergies: Mushrooms, aloe, iodine MRI solution; "Known allergies: aloe" (unspecified if ongoing), notes: Known allergies: Mushrooms, aloe, iodine MRI solution; "Known allergies: iodine MRI solution" (unspecified if ongoing), notes: Known allergies: Mushrooms, aloe, iodine MRI solution. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EP7543, Location of injection: Arm Left, Vaccine Administration Time: 04:45 PM), administration date: 28Mar2021, for COVID-19 immunization. No other vaccines were given within 4 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. The following information was reported: HEADACHE (disability), outcome "not recovered", described as "Continual 24/7 head pain"; OCCIPITAL NEURALGIA (disability), outcome "not recovered", described as "neuralgia in occipital and trigeminal areas of the head."; TRIGEMINAL NEURALGIA (disability), outcome "not recovered", described as "neuralgia in occipital and trigeminal areas of the head. Debilitating."; ASTHENIA (disability), outcome "not recovered", described as "Debilitating.". The events "continual 24/7 head pain", "neuralgia in occipital and trigeminal areas of the head." and "neuralgia in occipital and trigeminal areas of the head. debilitating." were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (04Jun2021) negative, notes: nasal Swab. Therapeutic measures were taken as a result of headache, occipital neuralgia, trigeminal neuralgia, asthenia.  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Herpes zoster
Clinical narrative: Shingles on left side of chest from the front to the middle of my back.; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Dec2021 09:00 (Lot number: FG3527) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Prostatomegaly" (unspecified if ongoing). Concomitant medication(s) included: FINASTERIDE; TERAZOSIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0150, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 06Apr2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ERV620, Location of injection: Arm Left, Vaccine Administration Time: 08:30 AM), administration date: 16Mar2021, for COVID-19 immunization. The following information was reported: HERPES ZOSTER (non-serious) with onset 27Dec2021 04:00, outcome "recovering", described as "Shingles on left side of chest from the front to the middle of my back.". The event "shingles on left side of chest from the front to the middle of my back." was evaluated at the physician office visit and emergency room visit. Therapeutic measures were taken as a result of herpes zoster.  Additional information: Facility type vaccine: Hospital. Known allergies: No. Other vaccine in four weeks: No and Other medications in two weeks reported in concomitant drugs section. Covid prior vaccination: No. Covid tested post vaccination: No. AE treatment: Valacyclovir.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Rash, SARS-CoV-2 test
Clinical narrative: chills; headache; fatigue; pink rash on body; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 08Mar2021 (Lot number: EN6205) at the age of 71 years as dose 2, single and intramuscular, administered in arm left, administration date 14Feb2021 (Lot number: EL9269) as dose 1, single for covid-19 immunisation. Relevant medical history included: "allergic to penicillin (rash)" (unspecified if ongoing), notes: I am allergic to penicillin (rash). The patient's concomitant medications were not reported. The following information was reported: CHILLS (non-serious) with onset 23Sep2021, outcome "recovered" (28Sep2021), described as "chills"; HEADACHE (non-serious) with onset 23Sep2021, outcome "recovered" (28Sep2021), described as "headache"; FATIGUE (non-serious) with onset 23Sep2021, outcome "recovered" (28Sep2021), described as "fatigue"; RASH (non-serious) with onset 23Sep2021, outcome "recovered" (28Sep2021), described as "pink rash on body". Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: Stroke; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: CEREBROVASCULAR ACCIDENT (medically significant) with onset Jan2022, outcome "recovering", described as "Stroke". During report about himself this consumer reported information about his sister. Caller's sister was the patient in this report. Caller's sister had a stroke 3 weeks ago and she had the Pfizer. She was recuperating.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Patient who received the 2nd Pfizer dose a week earlier for the COVID; Patient who received the 2nd Pfizer dose a week earlier for the COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 15 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Patient who received the 2nd Pfizer dose a week earlier for the COVID".  Clinical course: Reporter stated, they had a patient who received the 2nd Pfizer dose a week earlier for the COVID, they were (Age withheld) (Further clarification was unknown), didn't know what the risk of that or repeating the dose or what and don't know we had reported it but just wanted the recommendations. When again probed for the concern, reporter stated, "they had already reported this, (Age withheld) year old who got the 2nd dose of the COVID vaccine a week 'earlier'. So curious about the clinical ramifications, repeating the dose thing and immunity stuff like that. Reporter stated, don't have LOT information unfortunately. QR comment: Patient count was unspecified over the call.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary mass, Back pain, Limb mass
Clinical narrative: my back, my lower back has a stabbing pain in it; in my arm there is lumps now;  Like lump in my armpit near towards my breast tissue; also on my left 'wrist' and then in my arm there is lumps now; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1), for COVID-19 immunization. The following information was reported: BACK PAIN (hospitalization), outcome "unknown", described as "my back, my lower back has a stabbing pain in it"; AXILLARY MASS (non-serious), outcome "unknown", described as "in my arm there is lumps now;  Like lump in my armpit near towards my breast tissue"; LIMB MASS (non-serious), outcome "unknown", described as "also on my left 'wrist' and then in my arm there is lumps now".  Clinical course: Patient was fine during the first dose, the patient had not side effects and then patient got the second dose and then patient experienced back lower back has stabbing pain. Patient had received second dose of the pfizer vaccine and patient back, and lower back has a stabbing pain in it now. Patient went to the hospital and further not clarified but patient was perfectly fine, before patient had not received any vaccine and they told to patient they don't know when it is gonna subside and then also on patient left 'wrist' and then in patient arm there is lumps now, they told that it should go away. Patient had an like armpit lump near towards patient breast tissue. Patient stated, she is perfectly healthy, there is really nothing wrong with her at all and has not been and then after patient got the vaccine and then patient back is having the worst pain ever. LOT#: Patient stated, "No, my vaccine card is in the car so I would have to go in the trunk and get it real quick." The patient had no received medications and any lab work. The patient had not received treatment. The patient had not received within 4 weeks prior to the vaccination.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: the booster put her away; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE) (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: COVID-19 vaccine (Dose 1; MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "no problems"; COVID-19 vaccine (Dose 2; MANUFACTURER UNKNOWN), for COVID-19 Immunization, reaction(s): "no problems". The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "the booster put her away".  Additional Information: The reporter stated that she felt depleted after her booster dose and had to drag herself out of bed the next day and that she knows someone who also had no problems with the first two doses, and then the booster put her away.  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Heart rate, Heart rate increased, Nausea, Overdose
Clinical narrative: Gave them a full vial of the COVID Vaccine without diluting; Gave them a full vial of the COVID Vaccine without diluting; My oldest is currently in the hospital experiencing dizziness, nausea and her heart rate is up; My oldest is currently in the hospital experiencing dizziness, nausea and her heart rate is up; My oldest is currently in the hospital experiencing dizziness, nausea and her heart rate is up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A child female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ERROR (hospitalization), OVERDOSE (hospitalization), outcome "unknown" and all described as "Gave them a full vial of the COVID Vaccine without diluting"; DIZZINESS (hospitalization), NAUSEA (hospitalization), HEART RATE INCREASED (hospitalization), outcome "unknown" and all described as "My oldest is currently in the hospital experiencing dizziness, nausea and her heart rate is up". The patient underwent the following laboratory tests and procedures: heart rate: heart rate is up. Clinical course: Patient had a nurse administer the wrong dose of vaccine to the child. She was supposed to dilute it, it was supposed to be something like 0.02ml and instead she gave them (as reported, not further specified) a full vial of the COVID Vaccine without diluting and the reporter's oldest was currently in the hospital experiencing dizziness, nausea and her heart rate was up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Gave them a full vial of the COVID Vaccine without diluting; Gave them a full vial of the COVID Vaccine without diluting; My oldest is currently in the hospital experiencing dizziness, nausea and her heart rate is up; My oldest is currently in the hospital experiencing dizziness, nausea and her heart rate is up; My oldest is currently in the hospital experiencing dizziness, nausea and her heart rate is up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A child female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (tris), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PRODUCT PREPARATION ERROR (hospitalization), OVERDOSE (hospitalization), outcome "unknown" and all described as "Gave them a full vial of the COVID Vaccine without diluting"; DIZZINESS (hospitalization), NAUSEA (hospitalization), HEART RATE INCREASED (hospitalization), outcome "unknown" and all described as "My oldest is currently in the hospital experiencing dizziness, nausea and her heart rate is up". The patient underwent the following laboratory tests and procedures: heart rate: heart rate is up. Clinical course: Patient had a nurse administer the wrong dose of vaccine to the child. She was supposed to dilute it, it was supposed to be something like 0.02ml and instead she gave them (as reported, not further specified) a full vial of the COVID Vaccine without diluting and the reporter's oldest was currently in the hospital experiencing dizziness, nausea and her heart rate was up.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Haemoptysis, Investigation, Pneumonia
Clinical narrative: bi-lateral pneumonia; coughing blood; heart issue/Heart inflammation; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date Feb2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PNEUMONIA (medically significant) with onset 2021, outcome "unknown", described as "bi-lateral pneumonia"; HAEMOPTYSIS (non-serious) with onset 2021, outcome "unknown", described as "coughing blood"; CARDIAC DISORDER (non-serious) with onset 2021, outcome "unknown", described as "heart issue/Heart inflammation". The events "bi-lateral pneumonia", "coughing blood" and "heart issue/heart inflammation" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: investigation: (2021) did not contract covid but heart was affected.  Clinical information: It was reported that it was also ruled out the possibility of having gene prone to a heart issue.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Hypoaesthesia, Neuralgia, Neuropathy peripheral, Pain in extremity, SARS-CoV-2 test
Clinical narrative: neuropathy flared up; My feet started hurting; Had Numb fingers; Also since the Vaccine my Tinnitus has flared up.; nerve pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2021 (Lot number: EL1685) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sinusitis" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: NEUROPATHY PERIPHERAL (non-serious) with onset 08Jan2021, outcome "not recovered", described as "neuropathy flared up"; PAIN IN EXTREMITY (non-serious) with onset 08Jan2021, outcome "not recovered", described as "My feet started hurting"; HYPOAESTHESIA (non-serious) with onset 08Jan2021, outcome "not recovered", described as "Had Numb fingers"; TINNITUS (non-serious) with onset 08Jan2021, outcome "not recovered", described as "Also since the Vaccine my Tinnitus has flared up."; NEURALGIA (non-serious) with onset 08Jan2021, outcome "not recovered", described as "nerve pain". The events "neuropathy flared up", "my feet started hurting", "had numb fingers", "also since the vaccine my tinnitus has flared up." and "nerve pain" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: Other; negative, notes: Nasal Swab; negative, notes: Nasal Swab; negative, notes: Unknown. Therapeutic measures were not taken as a result of neuropathy peripheral, pain in extremity, hypoaesthesia, tinnitus, neuralgia.  Additional information: Patient did not receive other vaccine in four weeks. Patient received other medications in two weeks. Patient did not have covid prior vaccination. Patient had no known allergies. Patient received second dose bnt162b2, administered in arm left, administration date 254Jan2021 (Lot number: EJ1284) as dose 2, single for covid-19 immunisation.   Follow-up attempts were completed. No further information was expected.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: neuropathy flared up; My feet started hurting; Had Numb fingers; Also since the Vaccine my Tinnitus has flared up.; nerve pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 60 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Jan2021 (Lot number: EL1685) at the age of 60 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sinusitis" (unspecified if ongoing); "Neuropathy" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: NEUROPATHY PERIPHERAL (non-serious) with onset 08Jan2021, outcome "not recovered", described as "neuropathy flared up"; PAIN IN EXTREMITY (non-serious) with onset 08Jan2021, outcome "not recovered", described as "My feet started hurting"; HYPOAESTHESIA (non-serious) with onset 08Jan2021, outcome "not recovered", described as "Had Numb fingers"; TINNITUS (non-serious) with onset 08Jan2021, outcome "not recovered", described as "Also since the Vaccine my Tinnitus has flared up."; NEURALGIA (non-serious) with onset 08Jan2021, outcome "not recovered", described as "nerve pain". The events "neuropathy flared up", "my feet started hurting", "had numb fingers", "also since the vaccine my tinnitus has flared up." and "nerve pain" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: negative, notes: Other; negative, notes: Nasal Swab; negative, notes: Nasal Swab; negative, notes: Unknown. Therapeutic measures were not taken as a result of neuropathy peripheral, pain in extremity, hypoaesthesia, tinnitus, neuralgia.  Additional information: Patient did not receive other vaccine in four weeks. Patient received other medications in two weeks. Patient did not have covid prior vaccination. Patient had no known allergies. Patient received second dose bnt162b2, administered in arm left, administration date 254Jan2021 (Lot number: EJ1284) as dose 2, single for covid-19 immunisation.   Follow-up attempts were completed. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased, Blood pressure increased, Blood pressure measurement, Chronic obstructive pulmonary disease
Clinical narrative: copd; High blood pressure; High cholesterol; Covid; came down with covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic Bronchitis" (unspecified if ongoing), notes: I have had years of chronic Bronchitis. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Covid"; SUSPECTED COVID-19 (medically significant) with onset 29Dec2021, outcome "recovered", described as "came down with covid"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "recovered", described as "copd"; BLOOD PRESSURE INCREASED (non-serious), outcome "recovered", described as "High blood pressure"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "recovered", described as "High cholesterol". The patient underwent the following laboratory tests and procedures: blood cholesterol: high; blood pressure measurement: high.  Clinical information: The patient came down with Covid 29Dec2021. The patient was fully vaccinated three shots at the age of 51. The patient believed patent had the Omicron variant. Patient was down for four days, but after that felt good. Patient do believe without the vaccine patient would have been in the ICU..  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: copd; High blood pressure; High cholesterol; Covid; came down with covid; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Chronic Bronchitis" (unspecified if ongoing), notes: I have had years of chronic Bronchitis. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 29Dec2021, outcome "unknown", described as "Covid"; SUSPECTED COVID-19 (medically significant) with onset 29Dec2021, outcome "recovered", described as "came down with covid"; CHRONIC OBSTRUCTIVE PULMONARY DISEASE (non-serious), outcome "recovered", described as "copd"; BLOOD PRESSURE INCREASED (non-serious), outcome "recovered", described as "High blood pressure"; BLOOD CHOLESTEROL INCREASED (non-serious), outcome "recovered", described as "High cholesterol". The patient underwent the following laboratory tests and procedures: blood cholesterol: high; blood pressure measurement: high.  Clinical information: The patient came down with Covid 29Dec2021. The patient was fully vaccinated three shots at the age of 51. The patient believed patent had the Omicron variant. Patient was down for four days, but after that felt good. Patient do believe without the vaccine patient would have been in the ICU..  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Internal haemorrhage, Ovarian cyst, Ultrasound scan vagina
Clinical narrative: It had burst and bled in my abdomen; I had a good sized ovarian cyst in my right ovary rupture; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date 19May2021 (Lot number: Er8735) at the age of 41 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Possible iodine allergy" (unspecified if ongoing), notes: Verbatim: Possible iodine allergy; "Seasonal allergies" (unspecified if ongoing), notes: Verbatim: Seasonal allergies; "Chronic pain" (unspecified if ongoing); "PVC's" (unspecified if ongoing), notes: Verbatim: PVC's; "PTSD" (unspecified if ongoing), notes: Verbatim: PTSD. The patient's concomitant medications were not reported. Past drug history included: Epinephrine for Numbing Medicine, reaction(s): "Known allergy: Reaction to numbing medicine with epinephrine", notes: Verbatim: Known allergy: Reaction to numbing medicine with epinephrine. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8734), administration date: 28Apr2021, when the patient was 40 years old, for COVID-19 Immunization. The following information was reported: INTERNAL HAEMORRHAGE (medically significant) with onset 20May2021, outcome "recovered with sequelae", described as "It had burst and bled in my abdomen"; OVARIAN CYST (medically significant) with onset 20May2021, outcome "recovered with sequelae", described as "I had a good sized ovarian cyst in my right ovary rupture". The events "it had burst and bled in my abdomen" and "i had a good sized ovarian cyst in my right ovary rupture" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: ultrasound scan vagina: (20May2021) it had burst and bled in my abdomen. Therapeutic measures were taken as a result of internal haemorrhage, ovarian cyst.  Additional information: patient reported that A Day after her second covid 19 shot, she had a good sized ovarian cyst in my right ovary rupture that she had no idea she has. She had to go to the ER and get an ultrasound transvaginal. It had burst and bled in her abdomen. She was fine now but have another cyst and just got her 3rd Pfizer covid-19 vaccine. No covid prior vaccination. No covid tested post vaccination.Therapeutic measured included check ups and  observations with pain meds and rest.  No follow-up attempts are possible. No further information is expected.