chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Covid positive; Covid positive; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect via a contactable consumer reported for patient (husband). This reporter reported similar events for 2 patients (reporter and reporter's husband). This is 2nd of 2 reports reported for reporter's husband. A male patient of an unspecified age received BNT162B2 via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The reporter and her husband both had vaccine on Friday and they discovered that they both are Covid positive on Monday. Reporter does not have symptoms but her husband (patient) does, the question is wants to know whether they should still get the second shot? Events outcome was unknown.  Information on the batch/lot number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021049653 Same reporter, same drug/event, different patient
Sex: M
Vaccine: PNC13
Symptoms: Drug hypersensitivity
Clinical narrative: Allergic to the vaccine; This is a spontaneous report from a Pfizer-sponsored program from a contactable consumer (patient's wife). A 76-year-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (unknown manufacturer), via an unspecified route of administration, on an unspecified date, at single dose, for immunisation.  The patient's medical history was not reported. Concomitant medications were none. The patient was allergic to the vaccine on an unspecified date with outcome of unknown.    No follow-up attempts are possible; information about lot/batch number cannot be obtained.  Pfizer is a Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) in the reporter's country. This may be a duplicate report if another Marketing Authorization Holder of pneumococcal 13-val conj vac (dipht crm197 protein) has submitted the same report to the regulatory authorities.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: Low grade fever; Chills; This is a spontaneous report from a contactable consumer reported for self. This female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) at single dose (Reason for no lot number: don't know if it is F179899) for covid-19 immunisation. She had low grade fever she mentioned 99.8, and she had chills. Outcome of the events was unknown.  Information on Lot/Batch has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Nausea, Vomiting
Clinical narrative: Nauseous; Throwing up; Severe stomach pains; This is a spontaneous report from a contactable consumer. A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number unknown) via unspecified route of administration on 08Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. The patient experienced nauseous, throwing up, severe stomach pains on 13Jan2021. The reporter described that the patient received the vaccine on 08Jan2021 and on 13Jan2021 he was nauseous, throwing up and had severe stomach pains. The reporter wondered if 5 days is too long to consider a side effect or not. The outcome of the events was unknown.   Information about lot/batch number has been requested.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain in extremity
Clinical narrative: some severe nausea to the point started on the 11Jan2021 that was very hard for her to talk to people; Soreness in my arm; Headache; This is a spontaneous report from a contactable consumer reported for self. This 35-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 06Jan2021 at single dose for covid-19 immunisation. Medical history and concomitant medications were none. And right after the vaccine the patient was okay. Into the next day (07Jan2021) the patient had soreness in her arm, and headache which was known as a common side effect of the vaccination. But as of Monday, had been experiencing some severe nausea to the point started on the 11Jan2021 that was very hard for her to talk to people. Because she was almost gag in. Every time she talked she felt like she was going to throw up just if she was upright she felt like she had to throw up. So, she reached out to her employee health services and they asked her to reach out to you guys. She just wanted to add that she didn't experience this portion right away, it took some days for her to feel this. No treatments received for the event nausea. Outcome of the event nausea was not recovered. Outcome of other events was unknown.  information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: fatigue; This is a spontaneous report from a contactable nurse(patient) via a sales representative.  A patient of unspecified age and gender received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunization .  The patient medical history and concomitant medications were not reported. Patient previously first dose BNT162B2 for COVID-19 immunization and experienced headache and arm pain.  The patient experienced fatigue after use of product, it was reported that it "laid me out for one day" described as fatigue as well.  Outcome was unknown.    Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: Headache; Muscle pain; Tiredness; This is a spontaneous report from a contactable consumer(patient). A patient of unspecified age and gender received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: Unknown), via an unspecified route of administration on 12Jan2021 14:00 at single dose for COVID-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced headache, muscle pain and tiredness in Jan2021. The outcome of events was unknown.    Information about lot/batch number has been requested.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Decreased appetite, Dysgeusia, Headache, Migraine
Clinical narrative: Nausea; vomiting; Metallic taste; Headache; migraine; didn't have an appetite; lost taste, lost the sense of taste; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported a 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176) via unspecified route single dose for COVID-19 immunization on 08Jan2021, 10 am, at 38-year-old. Medical history was not reported. Concomitant medication included: celecoxib (CELEXA) 10 mg for an anti-depressant; alprazolam (XANAX) 0.25mg three times a day. Once the patient took that second vaccine, she had the metallic taste and had some headache and migraine at that time (08Jan2021). When the patient got the vaccine, within one minute, she started getting her usual migraine on the right side of head (08Jan2021), that was pretty much instantly. She didn't have an appetite (Jan2021), she only vomited when she ate. She had nausea and vomiting, it was about 2 o'clock that afternoon (08Jan2021, 2 pm). Every time she ate, she vomited and lost taste, lost the sense of taste. The patient was still nauseated (Hence, ongoing checked for nausea) and she hadn't tasted anything. She hadn't drink or ate anything yet this morning but last night her taste was starting to come back. But she still couldn't identify something. No treatment received. Action taken for BNT162B2 was not applicable. Outcome of the event nausea was not resolved, outcome of the other events was unknown.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nausea; vomiting; Metallic taste; Headache; migraine; didn't have an appetite; lost taste, lost the sense of taste; This is a spontaneous report from a Pfizer-sponsored program Pfizer First Connect. A contactable consumer (patient) reported a 38-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK4176) via unspecified route single dose for COVID-19 immunization on 08Jan2021, 10 am, at 38-year-old. Medical history was not reported. Concomitant medication included: celecoxib (CELEXA) 10 mg for an anti-depressant; alprazolam (XANAX) 0.25mg three times a day. Once the patient took that second vaccine, she had the metallic taste and had some headache and migraine at that time (08Jan2021). When the patient got the vaccine, within one minute, she started getting her usual migraine on the right side of head (08Jan2021), that was pretty much instantly. She didn't have an appetite (Jan2021), she only vomited when she ate. She had nausea and vomiting, it was about 2 o'clock that afternoon (08Jan2021, 2 pm). Every time she ate, she vomited and lost taste, lost the sense of taste. The patient was still nauseated (Hence, ongoing checked for nausea) and she hadn't tasted anything. She hadn't drink or ate anything yet this morning but last night her taste was starting to come back. But she still couldn't identify something. No treatment received. Action taken for BNT162B2 was not applicable. Outcome of the event nausea was not resolved, outcome of the other events was unknown.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Headache, Pain, Pyrexia
Clinical narrative: body pain/ Soreness; Headache; Fever up to 101.7; Shivers; This is a spontaneous report from a contactable consumer (patient's husband). A 62-year-old female patient received first dose BNT162B2 of (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL3246, expiration date: Apr2021), via an unspecified route of administration on left arm on 14Jan2021 10:00 at SINGLE DOSE for COVID-19 immunization (patient is a medical worker). There were no medical history and concomitant medication. The patient noticed about 21:00 on 14Jan2021, she was having body pain and a headache. The patient's husband took her upstairs and took her temperature and she had a fever and then she got the shivers which went on for quite a while. The hot bath seemed to help. She has had no other treatment. The patient's husband stated that his wife and he both got inoculated at the local hospital. He was fine but his wife has a fever up to 101.7 and he was asking if she take ibuprofen as she has a roaring headache and she was sore. The patient has been taking baths to relieve the soreness. No prior vaccinations (within 4 weeks). No additional vaccines administered on same date of the Pfizer vaccine. No event required a visit to physician or emergency room. There were currently no vaccines available for the second dose, but she is planning to get the second dose 31Jan2021. The outcome of the event Shivers was recovered on 14Jan2021 and the outcome of the other events were not recovered.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache
Clinical narrative: joint pains; headaches; This is a spontaneous report from a contactable other health professional. A 66-year-old female patient received the second dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number: EL3246), intramuscularly on 11Jan2021 at 10:00 at a single dose for COVID-19 immunization.  Medical history included pre-diabetic from an unknown date and unknown if ongoing, high cholesterol from an unknown date and unknown if ongoing; known allergies: no. The patient previously received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; first dose-lot number: EJ1685, intramuscularly, in the left arm at 19:30) for COVID-19 immunization on 22Dec2020. Concomitant medications included calcium (MANUFACTURER UNKNOWN), metformin (MANUFACTURER UNKNOWN), vitamin d (MANUFACTURER UNKNOWN), simvastatin (ZOCOR); all taken for an unspecified indication from an unspecified date to an unspecified date. On 12Jan2021 at 03:00, the patient experienced: joint pains and headaches; no treatment was reached.  The clinical outcome of the events was recovered in Jan2021. There were no other vaccines within four weeks of the suspected vaccine. The patient did not have COVID prior to the vaccination. The patient was not tested for COVID post vaccination.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia oral
Clinical narrative: numb tongue; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received bnt162b2 (PFIZER- BIONTECH COVID-19 VACCINE) via an unspecified route of administration on an unspecified date at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported. The patient experienced numb tongue on an unspecified date. Event took place after use of product. The outcome of event was unknown.  Information on the Lot/Batch number has been requested.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness (intermittent); This is a spontaneous report from a contactable consumer (patient). An 84-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; lot number and expiry date: not reported), via an unspecified route of administration on 07Jan2021 at 16:00 at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously took ciprofloxacin (CIPRO) and experienced allergies. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. On 08Jan2021 at 07:00, the patient experienced dizziness (reported as intermittent for 5 days). Patient was given an unspecified treatment for the event. Since the vaccination, the patient has not been tested for COVID-19. The patient was not pregnant at the time of vaccination. The outcome of the event was recovering.  Information on the lot/batch number has been requested.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Fatigue, Headache, Inappropriate schedule of product administration, Nausea
Clinical narrative: Nausea; vomiting; Fever of 101.7; Body aches all over; Headache; Fatigue; Swelling and bruising at injection site; Swelling and bruising at injection site; dose number 1 on 27Dec2020/dose number 2 on 13Jan2021; This is a spontaneous report from a contactable consumer (patient herself). A 23-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3302, expiry date May2021), via an unspecified route of administration, on 13Jan2021 08:45 am, at single dose, on the left arm, for covid-19 immunization. Medical history included GERD, asthma, and allergies: kiwi fruit. The patient's concomitant medications were not reported. The patient previously took hyoscyamine and experienced allergies; and previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EJ1685, expiry date May2021) on 27Dec2020 09:15 am, for covid-19 immunization at the age of 23-years-old with vaccination location on the left arm. The patient experienced nausea with vomiting, fever of 101.7, body aches all over, headache, fatigue, swelling and bruising at injection site - all on 13Jan2021 at 15:45 (reported as 03:45 pm). No treatment was received for these events except for fever (with acetometaphine and ibuprofen in system). The patient had no COVID prior vaccination, had no other vaccines received in four weeks and, had not been COVID tested post-vaccination. The outcome of event dose number 1 on 27Dec2020/dose number 2 on 13Jan2021 was unknown; while the outcome of all the other remaining events was recovering.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Vaccination site bruising, Vaccination site swelling, Vomiting
Clinical narrative: Nausea; vomiting; Fever of 101.7; Body aches all over; Headache; Fatigue; Swelling and bruising at injection site; Swelling and bruising at injection site; dose number 1 on 27Dec2020/dose number 2 on 13Jan2021; This is a spontaneous report from a contactable consumer (patient herself). A 23-year-old female patient (not pregnant) received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EL3302, expiry date May2021), via an unspecified route of administration, on 13Jan2021 08:45 am, at single dose, on the left arm, for covid-19 immunization. Medical history included GERD, asthma, and allergies: kiwi fruit. The patient's concomitant medications were not reported. The patient previously took hyoscyamine and experienced allergies; and previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, lot number EJ1685, expiry date May2021) on 27Dec2020 09:15 am, for covid-19 immunization at the age of 23-years-old with vaccination location on the left arm. The patient experienced nausea with vomiting, fever of 101.7, body aches all over, headache, fatigue, swelling and bruising at injection site - all on 13Jan2021 at 15:45 (reported as 03:45 pm). No treatment was received for these events except for fever (with acetometaphine and ibuprofen in system). The patient had no COVID prior vaccination, had no other vaccines received in four weeks and, had not been COVID tested post-vaccination. The outcome of event dose number 1 on 27Dec2020/dose number 2 on 13Jan2021 was unknown; while the outcome of all the other remaining events was recovering.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Dissociation, Fatigue, Feeling drunk, Lymph node pain
Clinical narrative: a bunch of swollen lymph nodes/lymph node was now larger/ a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary; a bunch of swollen lymph nodes/lymph node was now larger/ a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary; feelings of like disconnection; Feelings of like of being drunk; another larger bulge under her right axillary and that one was causing off and on under the armpit, she was getting some shooting pain; Fatigue; This is a spontaneous report from a contactable Nurse. This 48-year-old female Nurse (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via unspecified route at left upper arm on 11Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension. Concomitant drugs included lisinopril for blood pressure/hypertension, omeprazole and vitamin supplements. Historical vaccine included the first dose of BNT162B2 (lot# EK5730) on 21Dec2020 for COVID-19 immunization and having a swollen lymph node along her collar bone on the left side which was on the side where she got the shot and it didn't really change much, it just kind of stayed the same size and it remained there for whole three weeks. Nurse stated then she got the second dose of the vaccine and thought that what she was having were a bunch of swollen lymph nodes, and that lymph node was now larger and she had a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary (12Jan2021) and that one was causing off and on under the armpit, she was getting some shooting pain and her lymph node was larger now as well, the lymph node along her collar bone. Nurse further stated she also had some intermittent fatigue that she expected and also off and on feelings of like disconnection or feelings of like of being drunk. But that's not very bothersome, that's just once in a while since 11Jan2021. But she was concerned about the swelling of lymph nodes. No treatment was received for events. Outcome of events was not recovered. Nurse believed that swollen lymph nodes, fatigue and feeling drunk were due to the Covid 19 Vaccine.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: a bunch of swollen lymph nodes/lymph node was now larger/ a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary; a bunch of swollen lymph nodes/lymph node was now larger/ a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary; feelings of like disconnection; Feelings of like of being drunk; another larger bulge under her right axillary and that one was causing off and on under the armpit, she was getting some shooting pain; Fatigue; This is a spontaneous report from a contactable Nurse. This 48-year-old female Nurse (patient) reported that she received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EJ1686), via unspecified route at left upper arm on 11Jan2021 at single dose for COVID-19 immunization. Medical history included hypertension. Concomitant drugs included lisinopril for blood pressure/hypertension, omeprazole and vitamin supplements. Historical vaccine included the first dose of BNT162B2 (lot# EK5730) on 21Dec2020 for COVID-19 immunization and having a swollen lymph node along her collar bone on the left side which was on the side where she got the shot and it didn't really change much, it just kind of stayed the same size and it remained there for whole three weeks. Nurse stated then she got the second dose of the vaccine and thought that what she was having were a bunch of swollen lymph nodes, and that lymph node was now larger and she had a really big bulge like above the collar bone and going towards her neck and then another larger bulge under her right axillary (12Jan2021) and that one was causing off and on under the armpit, she was getting some shooting pain and her lymph node was larger now as well, the lymph node along her collar bone. Nurse further stated she also had some intermittent fatigue that she expected and also off and on feelings of like disconnection or feelings of like of being drunk. But that's not very bothersome, that's just once in a while since 11Jan2021. But she was concerned about the swelling of lymph nodes. No treatment was received for events. Outcome of events was not recovered. Nurse believed that swollen lymph nodes, fatigue and feeling drunk were due to the Covid 19 Vaccine.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: When I got my first half of vaccine I did have a swollen lymph node along my collar bone on the left side; This is a spontaneous report from a contactable nurse. This 47-year-old female nurse reported that she received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, LOT#: EK5730) at single dose in the left upper arm for vaccination on 21Dec2020. Relevant history included Hypertension. Relevant concomitant drug included Lisinopril 10 mg daily for blood pressure, Omeprazole 20 mg daily,  Vitamin Supplements. The nurse stated, " When I got my first dose of vaccine I did have a swollen lymph node along my collar bone on the left side which is on the side where I got the shot and it didn't really change much. It just kind of stayed the same size and it remained there for whole three weeks.  This small one along my collar bone that started right after the first vaccine and that has stayed the whole time. But got bigger after my second."  No treatment was received. The outcome of event was not resolved. The patient believed the swollen lymph nodes were due to the Covid 19 Vaccine.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea, Oropharyngeal pain, Pain
Clinical narrative: Nausea; chills; fever; tiredness; sore throat; body aches; This is a spontaneous report from a non-contactable healthcare professional. A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. On an unspecified date, the patient experienced nausea, chills, fever, tiredness, sore throat, and body aches. No treatment was received for the adverse events. Clinical outcome of the events was recovering.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Nausea; chills; fever; tiredness; sore throat; body aches; This is a spontaneous report from a non-contactable healthcare professional. A 25-year-old female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number and expiry date not reported), via an unspecified route of administration on an unspecified date at single dose for COVID-19 immunisation. Medical history was none. The patient was not pregnant at the time of vaccination. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, the patient has not been tested for COVID-19. The patient had no allergies to medications, food, or other products. Concomitant medications were not reported. On an unspecified date, the patient experienced nausea, chills, fever, tiredness, sore throat, and body aches. No treatment was received for the adverse events. Clinical outcome of the events was recovering.  No follow up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac disorder, Chest pain, Headache
Clinical narrative: Headache with the first COVID-19 Vaccine; A little bit of chest pain; Heart Troubles; This is a spontaneous report from a contactable consumer. This 56-year-old female consumer reported that she the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ1685) at single dose for vaccination on 22Dec2020. Relevant medical history included Rheumatoid, Asthma, Artery disease, Gastroparesis.  Relevant concomitant drugs were unknown. The patient had a headache with the first COVID-19 Vaccine and a little bit of chest pain. Stated she has heart troubles. Outcome of events was unknown.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Sinus congestion, Weight
Clinical narrative: She is now feeling little congestion like sinus; Tightness in chest; This is a spontaneous report from a Pfizer-sponsored program. A contactable 47-year-old female Consumer (patient) reported that she received first dose of bnt162b2 (BNT162B2), via an unspecified route of administration on Jan2021 at single dose for covid-19 immunisation. The patient medical history was not reported. The patient's concomitant medications were not reported. The patient reported she is now feeling little congestion like sinus and tightness in chest in Jan2021 with outcome of unknown. She was not sure if it's from the vaccine. No treatment was received. The patient underwent lab tests and procedures which included weight: was like 200 pounds lbs on an unknown date.    information on the batch/lot number has been requested.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, SARS-CoV-2 test positive
Clinical narrative: Felt tired; Headache; Arm sore; patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything; patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything; This is a spontaneous report from a contactable consumer reported for self. This 57-year-old female patient received the first dose of BNT162B2 (Lot number ELD140, Expiry Date Mar2021) via unspecified route of administration on an unspecified date at single dose, and second dose of BNT162B2 (maybe the same Lot/ Expiry date as the first dose) via unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient medical history and concomitant medications were not reported. It was reported that patient tested positive and had the second dose of the vaccine; patient didn't have any chills or anything. The patient clarified that she was tested positive at work. The patient had the nose swab 12Jan2021 at job and the patient had the second dose of the shot (vaccine). The patient stated that she felt tired in the morning and had headache and arm was sore, other than that the patient felt she was fine. The patient didn't have any chills or anything. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Chills; Body ache; Fever; Headache; This is a spontaneous report from a non-contactable consumer (patient). A patient of unspecified age and gender received first dose of BNT162B2 (batch/lot number was EL1284, expiration date was unknown) via an unspecified route of administration on 12Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. On 12Jan2021, patient was fine and then today (on 13Jan2021), this morning, patient had the symptoms of having the chills, body ache, fever and headache. The outcome of events was unknown.  No follow-up attempts are possible. No further information is expected.
Age: 1.25
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth
Clinical narrative: red warm welt at injection site; red warm welt at injection site; welt at injection site; This is a spontaneous report from a contactable nurse via a Pfizer sponsored program. This contactable nurse reported same event for two patients. This is the second of two reports. A 15-month-old patient of an unspecified gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Solution for injection in pre-filled syringe, 0.5 ml, lot number: DL2971, expiry date: 30Nov2022, NDC number of Prevnar 13: 0000519-71-02) via intramuscular route in right thigh on 12Jan2021 at 0.5 mL, single for immunization. Patient had no medical history. Concomitant medications were not reported. It was reported that, she is calling about Prevnar 13, states she just opened a new Lot of the Prevnar and the first two doses administered, both patients had adverse reactions. States that she was no longer going to use that Lot number at this time for fear that it may continue. Agent state the product information is: Patient was 27lb 8 ounces at time of injection. Gender not provided, Patient received vaccine on 12Jan2021, on 14Jan2021 a warm red welt at the injection site was reported. Reporter considered events as non-serious. Treatment was a cool compress to the site and the welt resolved in a couple of days. Outcome of events was recovered on 16Jan2021. The relatedness of event red warm welt at injection site was unknown. Relatedness of drug to reaction(s)/event(s) for Red warm welt at injection site at Source of assessment was Primary Source Reporter and Method of assessment was Global Introspection.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021058499 same reporter/drug/event, different patient
Age: 44.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure increased, Dizziness
Clinical narrative: Elevated blood pressure (180/116 highest recorded); dizziness; weakness lasting several hours; This is a spontaneous report from a contactable consumer (patient).  A 44-years-old male patient received the first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration in the left arm on 20Jan2021 14:15 at single dose for COVID-19 immunisation at Public Health Clinic/Veterans Administration facility. The patient medical history was not reported. Concomitant medication included atorvastatin (LIPITOR), 40 mg daily, butalbital, caffeine, paracetamol (FIORICET). The patient experienced elevated blood pressure (180/116 highest recorded), dizziness and weakness lasting several hours on 20Jan2021 14:30 with outcome of recovering. The events were considered life-threating (immediate risk of death from the event) and resulted in Doctor or other healthcare professional office/clinic visit, Emergency room/department or urgent care visit. No treatment was performed. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: tested positive for COVID via nasal swab; tested positive for COVID via nasal swab; This is a spontaneous report from a contactable healthcare professional. A 51-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ165), via an unspecified route of administration at left arm on 17Nov2020 18:45 at single dose for covid-19 immunisation. The patient's medical history and concomitant medications were not reported. The patient tested positive for COVID via nasal swab on 27Dec2020. The outcome of the events was unknown.; Sender's Comments: The 51-year-old male received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EJ165), on 17Nov2020 and tested positive for COVID via nasal swab on 27Dec2020. It was unknown whether he received second dose.   Based on the information currently available, a lack of efficacy with the suspected vaccine BNT162B2 in this patient cannot be completely excluded.  Further information is needed for full meaningful medical assessment.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Every year has an allergic reaction to the flu vaccine; Initial information regarding this unsolicited valid non-serious case received from a consumer via other company and transmitted to Sanofi on 30-Dec-2020.  The case involves a 36 year old female patient who had allergic reaction (hypersensitivity) every year, while she received INFLUENZA VACCINE (flu vaccine).  The patient's past vaccination included Pertussis vaccine for prophylactic vaccination as a kid and she had a severe allergic reaction which was described as almost anaphylactic (anaphylactic reaction).   Medical history, concomitant medication, past medical treatment 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 expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, it was reported that, the patient developed a non-serious allergic reaction (hypersensitivity), every year, unknown latency following the administration of INFLUENZA VACCINE.  Relevant laboratory test was not reported.  DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL) was given as a corrective treatment.  It was reported that recently the patient had already been diagnosed twice with COVID-19, she has not received the vaccine yet.  At the time of reporting, the outcome was unknown for the reported event.  There would be no information available on batch number for this case.
Age: 86.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: products were exposed to a temperature of 9.4 degrees Celsius and were out of range for a total of  76 hours  due to malfunction of refrigerator with no adverse event; Initial information regarding an unsolicited valid non-serious case received from a nurse via phone at a call center from The Agency on 06-Jan-2021.  This case involved a 86-year old female patient who was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which was exposed to a temperature of 9.4 degrees Celsius and were out of range for a total of  76 hours  due to malfunction of refrigerator with no adverse event (Product storage error).  Medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 05-Jan-2021, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE 0.7 mL pre-filled syringe (lot number: UJ469AA, expiry date: 30-Jun-2021) via intramuscular route in the left deltoid for prophylactic vaccination.  On 05-Jan-2021, it was reported that the patient was vaccinated with INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which was exposed to a temperature of 9.4 degrees Celsius and were out of range for a total of  76 hours  due to malfunction of refrigerator with no adverse event (Product storage error).   It was an actual medication error due to product storage error.  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 holders 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: U
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: allergic reaction; Initial information was received on 11-Jan-2021 regarding an unsolicited valid non-serious from other health care professional.  This case involves a patient of unknown age who experienced allergic reaction (hypersensitivity), 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 experienced allergic reaction (hypersensitivity).  No laboratory data was reported.  Outcome of the events was reported as unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: gets the flu; 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 experienced flu, while being received  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 experienced flu.  No laboratory data was reported.  It was not reported if the patient received any corrective treatment.  Outcome of the events was reported as unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: sick in bed; Initial information was received on 20-Jan-2021 regarding an unsolicited valid non-serious from a consumer/ non-heath care professional.  This case involves a 76-year old patient who got sick (illness), while being received vaccine INFLUENZA VACCINE.  Past medical history, medical treatment(s), past vaccination(s) and family history were not provided.  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 sick in bed (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: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: given a double dose of the Fluzone Quadrivalent, first dose given on 09Nov2020 and second dose given 06Jan2021 with no adverse event; Initial information regarding an unsolicited valid non-serious case received on 06-Jan-2021 from other health professional (Nurse) via call center.  This case involved a 71 year old male patient who received a 0.5 ml first dose of vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (lot number- UJ476AA and expiry date- 30-Jun-2021), via unknown route at unknown administration site, on 09-Nov-2020 and second dose given 06-Jan-2021 (Extra dose administered).  The patient's medical history, medical treatments, vaccinations, concomitant medications and family history were not provided.  It was an actual medication error given a double dose of the Fluzone Quadrivalent, first dose given on 09-Nov-2020 and second dose given 06-Jan-2021 (Extra dose administered)..    At the time of reporting, the patient had no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB
Symptoms: Product storage error
Clinical narrative: received a dose of Pentacel after it 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- 00418447) and transmitted to Sanofi on 06-Jan-2021.  This case is linked with 2021SA005526, 2021SA006645 (same reporter).  This case involved a 2 months old male patient who received a 0.5 ml first dose of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot: UJ382AA, expiration date: 01-Oct-2021) once via unknown route at left vastus lateral 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 reason documented in that case for the temperature excursion was a technical malfunction of the refrigerator. The reporter wanted to know how they should proceed and if they should revaccinate the patient. Doctor/emergency room visit on 05-Jan-2021.  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.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: a patient received a Pentacel vaccine which was exposed at the actual temperature of 22.7 degrees Fahrenheit, which rendered it unsuitable for use with no Adverse event; Initial information regarding an unsolicited valid non-serious case received on 06-Jan-2021 from the other health care professional.  This case involves a 4 months old female patient who received a 0.5 ml second dose of QUADRIVALENT INFLUENZA VACCINE [FLUZONE] which was exposed at the actual temperature of 22.7 degrees Fahrenheit (lot number: UJ559AB, expiry date: 14-May-2021), via an unknown route at left vastus lateral on 29-DEC-2020 (Product storage error).  The patient's medical history, medical treatments, vaccinations and family history were not provided.  List concomitant or no other vaccines not asked.  It was an actual medication error due to product storage error temperature too low (latency: same day).   At the time of reporting, the patient had no adverse event.  Description: Caller advised previously reported temperatures on inquiry: 00408503 were incorrect. The lowest temperature reached was 22.7 degrees F. Also advised PENTACEL was given to patient, wants to know how they should proceed. Should we re-vaccinate the patient who received Pentacel. He provides Adverse Event (AE) information: It is noted that 408503 did not contain AE information, as the reason documented in that case for the temperature excursion was a technical malfunction of the refrigerator.  Additional Description of event: The facility initially reported a temperature excursion of 32.5 degrees Fahrenheit and were cleared to immunize based on that temperature. However, on further review, it was discovered they made a mistake and the actual temperature the vaccines were exposed to was 22.7 degrees Fahrenheit. During that time period, three patients received vaccines that were actually unsuitable for use. The patient received a dose of Pentacel after the vaccine was exposed to a temperature excursion of 22.7 degrees Fahrenheit, which rendered it unsuitable for use.   Emergency Room/Doctor visit and date 29-Dec-2020. Administering physician Vaccine was administered by a nurse. Product used: Used. First time product used: No and Still using product: No.  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.