chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Product use issue, Rash, Rash papular
Clinical narrative: Severe joint pain; Wrist pain; Knee and elbow pain; Knee and elbow pain; Raised rash on hands and shin; Raised rash on hands and shin; Raised rash on hands and shin; condition has not improved and seems to be getting worse; Patient is currently breastfeeding; Patient is currently breastfeeding; This is a spontaneous report from a contactable Health Care Professional. A 30-year-old female patient who is currently breastfeeding received the first dose of BNT162B2 (Pfizer-Biontech Covid-19 Vaccine) at single dose, on an unspecified date, for COVID-19 immunisation. Relevant medical history and concomitant medications were unknown. On an unspecified date, 3 weeks after the vaccination, the patient experienced severe joint pain, wrist pain, knee and elbow pain (10 out of 10 knee and elbow pain), raised rash on hands and shin. Bloodwork were done in order to clarify that there were no underlying conditions, but patient stated pain was still severe a couple days later. Patient initially went to the emergency room thinking it was bladder infection and mastitis and that was not the case since her condition did not improve and seem to be getting worse. The patient did not recover from the events at time of this report.   Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021037719 Parent/fetus cases
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Feeling hot, Hot flush, Illness
Clinical narrative: sick; With the first dose he got tired and had malaise, and body aches for two days; With the first dose he got tired and had malaise, and body aches for two days; With the first dose he got tired and had malaise, and body aches for two days; felt warmth in the arm; hot flash; just got really hot; This is a spontaneous report from a contactable consumer (patient himself).  This 52-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ELO140), via an unknown route, on 23Dec2020 (at 06:00 AM), at single dose in the left upper arm on 23Dec2020 for COVID-19 immunization, administered at hospital. The patient had COVID-19 from 17Jul2020 to 14Aug2020 for which he was not hospitalized but he was pretty sick and had circulations issues; he had a little of numbing and tingling in his left three fingers after COVID virus. The patient clarified left three fingers as his middle finger, index finger, and ring finger. He had numbing and tingling in his toes as well. Relevant concomitant medications included ubidecarenone (COQ-10), rosuvastatin calcium (CRESTOR OD), monascus purpureus (RED YEAST RICE PLUS), and acetylsalicylic acid (BABY ASPIRIN). With the first dose he got tired and had malaise, and body aches for two days: He got the vaccine after working that night (He works in the intensive care unit). He got it at 6:00 AM. He felt warmth in the arm. It went all the way down the left arm. He got a hot flash. He stayed there for 15 minutes and was fine, but just got really hot. He finished his shift and didn't have any other reactions. He went to sleep and woke up in the afternoon on the 23Dec2020 and went to work. He didn't feel anything at that time. He was working six or seven days in a row. When he was working that night was when he started feeling body aches and fatigue. He didn't even put two and two together that it was from the vaccine. He felt like he needed to take something. His body temp was normally 97 and when he checked it was 98. He took a little ibuprofen (MOTRIN) and felt a lot better after taking it. He slept when he got home and had body aches and fatigue for a couple of days. He cancelled going away for a couple of days. By noon on 25Dec2020 he was feeling like he was getting back to normal. He continued to lay around all day and didn't do much. He was sick with the first and was expecting to be more sick with this one. He wanted to give himself an extra day before he had to go back to work. The patient had recovered from the event 'with the first dose he got tired and had malaise, and body aches for two days' on 25Dec2020 while the outcome of the remaining events was unknown.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pain, Vaccination site warmth
Clinical narrative: sick; With the first dose he got tired and had malaise, and body aches for two days; With the first dose he got tired and had malaise, and body aches for two days; With the first dose he got tired and had malaise, and body aches for two days; felt warmth in the arm; hot flash; just got really hot; This is a spontaneous report from a contactable consumer (patient himself).  This 52-year-old male received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number ELO140), via an unknown route, on 23Dec2020 (at 06:00 AM), at single dose in the left upper arm on 23Dec2020 for COVID-19 immunization, administered at hospital. The patient had COVID-19 from 17Jul2020 to 14Aug2020 for which he was not hospitalized but he was pretty sick and had circulations issues; he had a little of numbing and tingling in his left three fingers after COVID virus. The patient clarified left three fingers as his middle finger, index finger, and ring finger. He had numbing and tingling in his toes as well. Relevant concomitant medications included ubidecarenone (COQ-10), rosuvastatin calcium (CRESTOR OD), monascus purpureus (RED YEAST RICE PLUS), and acetylsalicylic acid (BABY ASPIRIN). With the first dose he got tired and had malaise, and body aches for two days: He got the vaccine after working that night (He works in the intensive care unit). He got it at 6:00 AM. He felt warmth in the arm. It went all the way down the left arm. He got a hot flash. He stayed there for 15 minutes and was fine, but just got really hot. He finished his shift and didn't have any other reactions. He went to sleep and woke up in the afternoon on the 23Dec2020 and went to work. He didn't feel anything at that time. He was working six or seven days in a row. When he was working that night was when he started feeling body aches and fatigue. He didn't even put two and two together that it was from the vaccine. He felt like he needed to take something. His body temp was normally 97 and when he checked it was 98. He took a little ibuprofen (MOTRIN) and felt a lot better after taking it. He slept when he got home and had body aches and fatigue for a couple of days. He cancelled going away for a couple of days. By noon on 25Dec2020 he was feeling like he was getting back to normal. He continued to lay around all day and didn't do much. He was sick with the first and was expecting to be more sick with this one. He wanted to give himself an extra day before he had to go back to work. The patient had recovered from the event 'with the first dose he got tired and had malaise, and body aches for two days' on 25Dec2020 while the outcome of the remaining events was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Rhinorrhoea, Vaccination site pain
Clinical narrative: Arm pain at injection site; Runny nose; Lightheaded; This is a spontaneous report from a non-contactable physician, the patient.  A 36-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 22Dec2020 (at the age of 36-years-old) as a single dose for COVID-19 immunization.  Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19.  There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination.  On an unknown date, the patient experienced arm pain at injection site, runny nose, and lightheaded. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcomes of arm pain at injection site, runny nose, and lightheaded were unknown.    No follow-up attempts are possible; information about lot number cannot be obtained.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Swelling face
Clinical narrative: Red, swollen and warm face, left side; Red, swollen and warm face, left side; Red, swollen and warm face, left side; This is a spontaneous report from a contactable nurse and a contactable physician.  A 39-year-old patient of an unspecified gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), intramuscular at left arm on an unspecified date at single dose for COVID-19 immunization. The patient medical history included anxiety, depression, cough, pain, paranasal sinus congestion, infection, hypertension, diarrhea, nausea and vomiting, constipation, type 2 diabetes mellitus, skin rash, erythema of skin, anemia, muscle spasm, asthma, hypercholesterolemia, allergy disorder, acute otitis media, gastroesophageal reflux disease, intellectual disability, acne vulgaris, otitis media, hypersensitivity condition, bacterial infection, dental disease, infective otitis externa, generalized ache or pain, allergies to cotton and thistle, each from an unknown date and unknown if ongoing. The patient's concomitant medications included paracetamol (TYLENOL), atorvastatin, cetirizine, cyclobenzaprine, esomeprazole magnesium (ESOMEPRA), ferrous sulfate, lisinopril, loperamide, metformin, venlafaxine, all from an unknown date and unknown if ongoing. On 14Jan2021 at 10:15, the patient experienced red, swollen and warm face, left side. Therapeutic measures were taken as a result of the events and included treatment with BENADRYL. The patient outcome of the events was recovering.   The information on the batch number has been requested.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: rash all over her stomach; a little pain at injection site; This is a spontaneous report from a contactable nurse (patient).  A 64-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 13Jan2021 at 15:00 at single dose for COVID-19 immunization.  The patient medical history and concomitant medications were not reported. On 13Jan2021, the patient experienced rash all over her stomach (7 hours after vaccination) and a little pain at injection site. The patient outcome of the events was unknown.   The information on the batch number has been requested.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Headache, Inappropriate schedule of product administration, Myalgia, Nausea
Clinical narrative: Headache; myalgia; nausea; diarrhea; second dose received on 14Jan2021; This is a spontaneous report from a contactable Physician.  A 31-year-old female Physician (patient) reported that received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number unknown), intramuscular at single dose into the left arm on 13Jan2021 at 01:15 PM for COVID-19 immunization. The patient had received the first dose on 13Dec2020 at 01:15 PM Intramuscular in Left arm. Medical history included migraines. On 14Jan2021 at 12:00 PM, the patient experienced headache, myalgia, nausea and diarrhea.  The patient was not Covid tested post vaccination. At the time of reporting the patient was recovering  Information about batch/lot number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin G, Body mass index, Body temperature, Chills, Headache
Clinical narrative: headache; fever to 101F; chills; body aches; congestion; This is a spontaneous report from a contactable physician. This physician reported for a 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Dec2020 at single dose for COVID-19 immunization. The patient's medical history included diagnosed with COVID on 10Jul2020 and 11 weeks of prolonged illness. The patient's concomitant medications were not reported. Patient with no significant risk factors except for a BMI of 34. On day 33 (13Aug2020) post diagnosis she was PCR and IgG positive. On 01Dec2020, patient had the first Pfizer Covid vaccine dose. The first 2-5 days (Dec2020) were described as very bad, fever to 101F, chills, headache, body aches, congestion. The week after she was somewhat better but didn't feel better until day 9 post vaccination. Outcome of the events was unknown.  Information on the Lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Pain, Polymerase chain reaction, Pyrexia
Clinical narrative: headache; fever to 101F; chills; body aches; congestion; This is a spontaneous report from a contactable physician. This physician reported for a 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 01Dec2020 at single dose for COVID-19 immunization. The patient's medical history included diagnosed with COVID on 10Jul2020 and 11 weeks of prolonged illness. The patient's concomitant medications were not reported. Patient with no significant risk factors except for a BMI of 34. On day 33 (13Aug2020) post diagnosis she was PCR and IgG positive. On 01Dec2020, patient had the first Pfizer Covid vaccine dose. The first 2-5 days (Dec2020) were described as very bad, fever to 101F, chills, headache, body aches, congestion. The week after she was somewhat better but didn't feel better until day 9 post vaccination. Outcome of the events was unknown.  Information on the Lot/batch number has been requested.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: got a shot of vaccine today but after that she tested positive; got a shot of vaccine today but after that she tested positive; This is a spontaneous report from a contactable nurse reported for self via Pfizer-sponsored program Pfizer First Connect. A 29-year-old female patient received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899), via an unspecified route of administration on 11Jan2021 at single dose for covid-19 immunisation. Medical history was not reported. The patient's concomitant medications were not reported. The patient already got a shot of vaccine today but after that she tested positive on 11Jan2021. Outcome of events was unknown.; Sender's Comments: No effect of the suspect vaccine BNT162B2 could be reasonably achieved to protect from the targeted infection/ disease due to the very short time lag. Instead, the positive test represents the pre-existing infection prior to vaccine use. Further information like confirmative COVID 19 nucleic acid/ PCR test together with any associated symptoms are needed for full medical assessment.
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: I tested positive yesterday for Covid 19; I tested positive yesterday for Covid 19; This is a spontaneous report from a contactable Other-HCP (patient). A 32-years-old male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number EH9899) , via an unspecified route of administration on 31Dec2020 at single dose for covid-19 immunisation.  Medical history reported as none.  There were no concomitant medications.  The patient tested positive for covid 19 on 09Jan2021. No treatment for the events.  The outcome of events was unknown.; Sender's Comments: Based on available information, a possible contributory role of BNT162B2 cannot be completely excluded for reported "tested positive for Covid 19".
Sex: U
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Nausea; Fever; This is a spontaneous report from a contactable consumer. A patient of unspecified age and gender received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number unknown) via unspecified route of administration on 11Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant mediations were not reported. This patient experienced fever and nausea on unspecified date in Jan2021. The outcome of events was not provided.   Information on the Lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Feeling abnormal, Malaise, SARS-CoV-2 test positive
Clinical narrative: Felt bad; Not feeling well; tested positive for COVID; Diagnosed with Covid; This is a spontaneous report from a contactable consumer (Patient) from a Pfizer-sponsored program Pfizer First Connect. This female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 05Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. Patient took the COVID-19 vaccine last Tuesday on the 05Jan2021, after she took it she felt bad in that evening, she was not feeling well. Patient tested COVID positive and diagnosed with COVID on an unspecified date in Jan2021. Patient inquired that can she still get the second dose that was supposed to have on 26th. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral
Clinical narrative: my first covid vaccine caused tingly lips; This is a spontaneous report from a contactable Health Professional reporting for herself. A 53-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number not provided, expiry date unknown) via an unspecified route of administration in the left arm at single dose on 23Dec2020 at 15:30 for COVID-19 immunization. The patient had allergy to codeine. Concomitant medications included metformin, atorvastatin, vortioxetine hydrobromide (TRINTELLIX), insulin glargine/lixisenatide (SOLIQUA). The patient reported that her first dose of the vaccine caused tingly lips. Onset date and outcome of the event were not reported.  Information about lot/batch number has been requested.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Body temperature, Chills, Fatigue, Feeling abnormal
Clinical narrative: Body aches; Chills; temperature was up to a 101; pains/she said she can't even move because it hurt; Fatigue; Felt horrible/felt very bad; This is a spontaneous report from a contactable Physician.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Jan2021 at single dose for COVID prevention. Medical history included breast cancer, rheumatoid arthritis. The patient's concomitant medications were not reported. The patient said that she felt horrible, she had body ache, pains and chills and that was just horrible. she felt very bad you know body aches and chills. She was a doctor, she wasn't even able to go to the work. She was not going to go to work tomorrow and her temperature was up to a 101 and she said she can't even move because it hurt when she move. Body aches, chills, fever, fatigue, she just said she just felt horrible. She did have some blood work done about three weeks ago from her oncologist. The outcome of events was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021044872 Same reporter, same drug, different patient
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Body aches; Chills; temperature was up to a 101; pains/she said she can't even move because it hurt; Fatigue; Felt horrible/felt very bad; This is a spontaneous report from a contactable Physician.  A female patient of an unspecified age received second dose of bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 11Jan2021 at single dose for COVID prevention. Medical history included breast cancer, rheumatoid arthritis. The patient's concomitant medications were not reported. The patient said that she felt horrible, she had body ache, pains and chills and that was just horrible. she felt very bad you know body aches and chills. She was a doctor, she wasn't even able to go to the work. She was not going to go to work tomorrow and her temperature was up to a 101 and she said she can't even move because it hurt when she move. Body aches, chills, fever, fatigue, she just said she just felt horrible. She did have some blood work done about three weeks ago from her oncologist. The outcome of events was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021044872 Same reporter, same drug, different patient
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Pain, Pyrexia
Clinical narrative: temperature was up to a 101 / fever; she could not even move because it hurt when she moved; felt very bad / Feels horrible; Body ache; Chills; fatigue; This is a spontaneous report from a non-contactable consumer (patient).  A 55-year-old female patient of an unspecified age received the 2nd dose of bnt162b2 (BNT162B2) at single dose on 11Jan2021 for covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  On 11Jan2021 night she felt very bad with body aches and chills but then on 12Jan2021 she was not even able to go to the work. She was not going to go to work on 13Jan2021 and her temperature was up to a 101 and she could not even move because it hurt when she moved. Body aches, chills, fever, fatigue, she just said she just feels horrible. She took two Ibuprofen maybe 200 mg, so probably total of 400 mg of Ibuprofen. The outcome of events was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling abnormal, Pain, Pyrexia
Clinical narrative: Fever; body ache; Miserable; Tired; This is a spontaneous report from a contactable consumer. This consumer reported same events for 2 patients. This is 2nd of 2 report. A patient of unknown age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on unknown date at single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient had fever, body ache, couldn't even lay in bed, the patient was miserable. The patient was tired. The outcome of all the events was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021044957 same reporter/drug/event, different patient.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular
Clinical narrative: Systemic rash all over the back, chest, stomach and thighs; Some spots on arms and legs; This is a spontaneous report from a contactable Nurse (patient). A 56-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number EL3248), via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation.  Medical history was none.  The patient's concomitant medications were not reported.  The patient stated, "I got my first dose yesterday at 4:30 and then everything was fine and then at about 10:30 that night, I got a systemic rash all over my back, my chest, my stomach and my thighs and there were some spots on my arms and my legs. So, I went ahead and had took some Benadryl and I just monitored the rash and made sure it wasn't going to my face, or my eyes or my throat. I never had any difficulty in breathing or anything but it definitely was a reaction to something that was in the vaccine." Treatment: Consumer stated, "I took Benadryl last night. It was a capsule, 25 mg. Indication: Consumer stated, "I work at a hospital and right now the hospital that I work at is not requiring that we get it but they just advised that we should. But they left it to us if we want to get it or not and they said that they just have the first doses available." The outcome of the events was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report from a non-contactable nurse (patient).  A female patient of an unspecified age received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at singled dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced sore arm on an unspecified date with outcome of unknown. The patient took ibuprofen after the first dose. She took 800mg of ibuprofen right before the second dose since her arm was sore.  No follow-up attempts are possible; Information about batch/lot number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Dizziness, Hypertension
Clinical narrative: Felt dizzy; Her BP shot up high; This is a spontaneous report from a Pfizer-sponsored program from a contactable Nurse. A female patient of an unspecified age received first dose bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at SINGLE DOSE for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient felt dizzy and her BP shot up high. The outcome of the events was unknown. Information on the lot/batch number has been requested.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Cholecystectomy, Pancreatitis acute, SARS-CoV-2 test negative, Sepsis
Clinical narrative: Acute pancreatitis with sepsis; Acute pancreatitis with sepsis; This is a spontaneous report from a contactable pharmacist, the patient.  A 48-year-old non-pregnant female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EK5730), via an unspecified route of administration on 17Dec2020 at 15:00 (at the age of 48-years-old) as a single dose for COVID-19 immunization.  Medical history included penicillin allergy. Prior to the vaccination, the patient was not diagnosed with COVID-19.  Concomitant medications included fexofenadine (MANUFACTURER UNKNOWN).  The patient did not receive any other vaccines within four weeks prior to the vaccination. On 28Dec2020, the patient experienced acute pancreatitis with sepsis, which were reported as serious for hospitalization and being life threatening. The patient had gone to the emergency room due to the event and was hospitalized for a total of 6 days.  On 29Dec2020 and 31Dec2020, the patient had COVID-19 nasal swabs performed and both results were negative. Therapeutic measures were taken as a result of acute pancreatitis with sepsis and included gall bladder removal. The clinical outcome of acute pancreatitis with sepsis was recovering.; Sender's Comments: Based on the temporal relationship, the association between the events pancreatitis with sepsis with BNT162b2 can not be completely excluded.  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: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: severe pain; This is a spontaneous report from a Pfizer-sponsored program. A contactable consumer (pharmacy intern) reported similar events for 2 patients. This is 1st of 2 reports.   A patient of unspecified age and gender received bnt162b2 (BNT162B2) at single dose on an unspecified date for Covid-19 immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced severe pain (not specified) on an unspecified date. The action outcome of event was unknown.  Information on lot/batch has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021057811 same reporter, different patient
Sex: U
Vaccine: FLUX
Symptoms: Influenza like illness, Vomiting
Clinical narrative: flu symptoms; vomited for 4 straight hours; Initial and additional information was received on 14-Dec-2020 regarding an unsolicited valid non-serious case from the non-healthcare professional via social media.  This case involved an unknown demographic patient who vomited (vomiting) and had flu symptoms (influenza), after the patient received INFLUENZA VACCINE.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.  On an unknown date (last year), the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer (batch number and other dosing details were not reported) for prophylactic vaccination.  On an unknown date, the patient vomited (vomiting) and had flu symptoms (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  Physician had advised the patient to avoid flu shot also the patient had suspected that he/she had reaction to something in that solution.  It was reported that, the flu can be life-threatening for people above 65year old with heart disease and preventive care could make a difference and these events labeled as type 1-B adverse event.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the outcome was not reported for influenza and after 4 hours duration (on an unknown date), the patient had recovered from vomiting.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: patient got sick; Initial information was received on 16-Jan-2021 regarding an unsolicited valid serious from a consumer/ non-heath care professional.  This case involves a patient of unknown age who got sick (illness), while being received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (batch number and other dosing details were not reported) at an unknown dose via unknown route and unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient got sick (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was reported as unknown.  There will be no information available regarding batch number in this case.
Sex: M
Vaccine: FLUX
Symptoms: Illness, Malaise
Clinical narrative: still ill after the double dose flu shot; ill; Initial information was received on 16-Jan-2021 regarding an unsolicited valid serious case received from a consumer  This case involved adult male patient who was still ill after the double dose flu shot (illness) and ill (malaise), while he received INFLUENZA VACCINE.  The patient's medical history, medical treatment(s), vaccination(s), concomitant medication (s) and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number and expiration date not reported via unknown route at unknown administration site for prophylactic vaccination.  On an unknown date, the patient was still ill after the double dose flu shot (illness) and ill (malaise), unknown latency following the administration of INFLUENZA VACCINE.   The patient was hospitalized (caused or prolonged) for this event.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for both the events.  There will be no information available on the batch number for this case.; Sender's Comments: This case concerns adult male patient who was still ill after the double dose flu shot and ill after vaccination with INFLUENZA VACCINE. It was unknown if the time to onset was compatible. However, concomitant medications,  patient's medical condition and laboratory tests ruling out alternate etiologies. Moreover, vaccination preceded the events. Based upon the reported information, the role of vaccine cannot be assessed.
Sex: M
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: he was out sick for 2 weeks; Initial information was received on 15-Jan-2021 regarding an unsolicited valid serious from a consumer/ non-heath care professional.  This case involves a patient of unknown age who was out sick for 2 weeks (illness), while being received vaccine INFLUENZA VACCINE.  Medical history, past medical treatment, vaccination, family history and concomitant medication were not reported.  Concomitant medications were not reported.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (batch number and other dosing details were not reported) at an unknown dose via unknown route and unknown administration site for prophylactic vaccination.  On an unknown date, (latency: unknown) after starting the suspect vaccine therapy, patient was out sick for 2 weeks (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was reported as unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Last flu shot patinet got made me sick; Initial information was received on 18-Jan-2021 regarding an unsolicited valid serious from a consumer/ non-heath care professional.  This case involves a patient of unknown age who got sick (illness), while being received vaccine INFLUENZA VACCINE.  Past vaccination(s) included INFLUENZA VACCINE.  Medical history, past medical treatment, family history and concomitant medication were not reported.  Concomitant medications were not reported.  On an unknown date in 1980, the patient received a dose of suspect INFLUENZA VACCINE (batch number and other dosing details were not reported) at an unknown dose via unknown route and unknown administration site for prophylactic vaccination.  On an unknown date in 1980, (latency: unknown) after starting the suspect vaccine therapy, patient who last flu shot an became sick (illness).  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  Outcome of the event was reported as unknown.  There will be no information available regarding batch number in this case.
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Product storage error
Clinical narrative: patient received a dose of Menactra after the vaccine was exposed to a temperature excursion of 22.7°F with no AE; Initial information regarding this unsolicited valid non-serious case was received from Other Healthcare Professional via Medical Information (Reference number- 00418272) and transmitted to Sanofi on 06-Jan-2021.  This case is linked with 2021SA005526, 2021SA006661(same reporter).  This case involves an 18 year old male patient who received a 0.5 ml second dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] (lot: U6827BA, expiration date: 18-Feb-2022) once via unknown route at right deltoid for prophylactic vaccination on an unknown date which was exposed to a temperature excursion of 22.7 degree Fahrenheit (product storage error).  The patient's medical history, medical treatments, vaccinations and family history were not provided. Concomitant therapies were not asked.  It was an actual medication error due to product storage error temperature too low.  The reporter stated that the facility initially reported temperature excursion of 32.5 degree Fahrenheit and were cleared to immunize based on that temperature. However, on further review, it was discovered facility made a mistake and the actual temperature the vaccines were exposed to was 22.7 degree Fahrenheit. During that time period, three patients received vaccines that were actually unsuitable for use. The reporter wanted to know how they should proceed and if they should revaccinate the patient.  No adverse event reported to the patient at the time of reporting.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: MNQ
Symptoms: Infant, Wrong product administered
Clinical narrative: gave a Menactra instead of an MMR yesterday with no AE; Initial information regarding this unsolicited valid non-serious case from Regulatory Authority (Reference number- 00421820) was received from Pharmacist and transmitted to Sanofi on 08-Jan-2021.  This case involved a 7 months old male patient who received a 0.5 ml dose of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA] instead of MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE [MMR] (lot: U6575AA, expiration date: 08-May-2021),  gave a Menactra instead of an MMR yesterday with no AE (Wrong vaccine administered). The dose was given in the left deltoid via intramuscular route.  Past vaccination included meningococcal vaccine(unknown brand) 2 years ago. The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was a actual medication error due to wrong vaccine administered (Wrong product administered).  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Fatigue, Somnolence
Clinical narrative: tired; sleeping; 18 year old who received 2 doses of MENACTRA  within minutes of each other; Initial information regarding this unsolicited valid non-serious case via Medical Information  (Reference number-00422339) was received from a Other Healthcare Professional and transmitted to Sanofi on 08-Jan-2021.  This case involved a 18 year old female patient who was tired (fatigue), sleeping (somnolence) and for whom 18 year old who received 2 doses of menactra  within minutes of each other (extra dose administered) was, while she received MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient's medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medication included HPV VACCINE; and VARICELLA ZOSTER VACCINE (VARICELLA VACCINE).  On an unknown date, the patient received a dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number and expiration date not reported via intramuscular route at the left arm for prophylactic vaccination.  On 07-Jan-2021, the patient was tired (fatigue), sleeping (somnolence) and for whom 18 year old who received 2 doses of menactra  within minutes of each other (extra dose administered) was reported, unknown latency following the administration of MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE.  No relevant laboratory data was reported.   It was not reported if the patient received a corrective treatment.  The event outcome was reported as unknown for tired and somnolence.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Disclaimer: Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  There will be no information available on the batch number for this case.
Sex: M
Vaccine: VARZOS
Symptoms: Acute respiratory distress syndrome, Acute respiratory failure, Endotracheal intubation, Hypoxia, Pneumonia
Clinical narrative: acute respiratory distress syndrome/ acute respiratory failure with hypoxia; pneumonia of the lower lobe; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not reported. On or about 15-NOV-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and the prevention of shingles (herpes zoster). On an unknown date, shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered acute respiratory distress syndrome, requiring hospitalization and intubation. He remained hospitalized for 16 days and was diagnosed with acute respiratory failure with hypoxia and pneumonia of the lower lobe. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to vaccination. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of pneumonia of the lower lobe and acute respiratory distress syndrome/ acute respiratory failure with hypoxia were determined to be disabling.  Upon internal review, the events of pneumonia of lower lobe and acute respiratory distress syndrome/ acute respiratory failure with hypoxia were considered to be medically significant.
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Deafness, Eczema, Herpes zoster, Post herpetic neuralgia
Clinical narrative: bilateral hearing loss; postherpetic neuralgia; intrinsic eczema; herpes zoster; This spontaneous report has been received from a lawyer, regarding a case in litigation and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant medications were not reported. On or around 18-OCT-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) vaccine (dose, route of administration, anatomical location, lot # and expiry date were not provided) for routine health maintenance and for the prevention of shingles (herpes zoster). On an unknown, date shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered shingles rashes on his lower back and mid left back, muscular lower back pain and loss of hearing. He was diagnosed with herpes zoster, postherpetic neuralgia, intrinsic eczema and bilateral hearing loss. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms resulted in physical limitations not present prior to using the vaccine. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment, and injury. As a direct and proximate result, the patient suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events was considered to be not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).   The events were determined to be disabling.  Upon internal review, the event of bilateral hearing loss was considered to be medically significant.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling cold, Paraesthesia, Vomiting
Clinical narrative: Tingling of the arms / Intermittent tingling in the leg opposite of the left arm; Vomiting; Cold/shivers; Cold/shivers; This case was reported by a pharmacist via call center representative and described the occurrence of tingling of extremity in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 5C29J, expiry date 25th March 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of chills (1st dose was received on an unknown date, refer linked case US2020AMR255397).   On 22nd December 2020 16:15, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 23rd December 2020, 1 days after receiving Shingrix, the patient experienced tingling of extremity, vomiting, cold and shivers. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the tingling of extremity, vomiting, cold and shivers were not recovered/not resolved.   It was unknown if the reporter considered the tingling of extremity, vomiting, cold and shivers to be related to Shingrix.  Additional details were provided as follows: The second dose of vaccine was administered day before the reporting date at 4:15pm at the pharmacy; which was given intramuscularly in the left deltoid. The patient had experienced tingling of the arms, vomiting, and intermittent tingling in the leg opposite of the left arm (where the injection was given) from the 2nd dose of the Shingrix vaccine.  The patient had also experienced colds/shivers. The reporter also stated that the patient did not experience swelling, shortness of breath, paralysis, or anything like that. The reporter consented to follow-up and provided contact information.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR255397:Same reporter, same suspect, same patient, diferent dose (1st dose)