chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 84.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Body temperature, Decreased appetite, Pyrexia
Clinical narrative: my temperature and it's at 99.3 F/a little fever; weak; I didn't have appetite; This is a spontaneous report from a contactable consumer (patient). An 84-year-old male patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot number: EL9264) via an unspecified route of administration on the left arm on 08Feb2021 at a single dose for COVID-19 immunization and apixaban (ELIQUIS) via an unspecified route of administration from an unspecified date and ongoing at an unspecified dose and frequency for an unspecified indication. Medical history included afib and heart rate (abnormal). Concomitant medication included propranolol hydrochloride (MANOPROLOL) for afib. The patient previously received first dose of BNT162B2 on 18Jan2021 for COVID-19 immunization (lot: EL1283 on the left arm) and experienced a little bit of soreness at the injection site. The patient took his temperature and it was at 99.3 F. Patient asked, "Is that within range? Can I take Tylenol?" The patient stated that when he first got his shot of the Pfizer Covid Vaccine at the (Hospital name) in (City name) he didn't have any problems or didn't experience any side effects. Then after receiving his 2nd shot on 08Feb2021, he mentioned that he started having trouble. On 10Feb2021, he started to experience some side effects and stated, "I was as weak as I could be, I didn't have appetite and I had a little fever. I just feel super weak but not like if you have corona. Now, I can sleep under oxygen and it doesn't bother me anymore and when I get up I don't need oxygen anymore and I can breathe freely." Wanted to know how long will his symptoms last. He was as weak as a rag, has a little fever that comes and goes, does not go over 101, stated he was taking Eliquis does not know if that was important or not, slept with oxygen but has not had any trouble breathing. Wondering if this was standard. The action taken for apixaban was unknown. Outcome of the event 'didn't have appetite' was unknown and not recovered for the other events.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Decreased appetite, Fatigue, Headache
Clinical narrative: Raised swollen lump at injection site; muscle and joint aches; muscle and joint aches; fatigue; headache; nausea; lack of appetite and energy; lack of appetite and energy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 10Feb2021 13:00 at a single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, High blood pressure, arthritis, obese, anxiety, depression. Concomitant medication included lamotrigine, duloxetine hydrochloride (CYMBALTA), ropinirole hydrochloride (REQUIP) and unspecified blood pressure meds. On 12Feb2021, the patient experienced raised swollen lump at injection site, muscle and joint aches, fatigue, headache and nausea, lack of appetite and energy. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has been tested for COVID-19, nasal swab on 04Dec2020: negative. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, SARS-CoV-2 test, Vaccination site mass
Clinical narrative: Raised swollen lump at injection site; muscle and joint aches; muscle and joint aches; fatigue; headache; nausea; lack of appetite and energy; lack of appetite and energy; This is a spontaneous report from a contactable consumer (patient). A 53-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE lot/batch number and expiration date not reported) via an unspecified route of administration on the left arm on 10Feb2021 13:00 at a single dose for COVID-19 immunization. Medical history included known allergies: Sulfa, High blood pressure, arthritis, obese, anxiety, depression. Concomitant medication included lamotrigine, duloxetine hydrochloride (CYMBALTA), ropinirole hydrochloride (REQUIP) and unspecified blood pressure meds. On 12Feb2021, the patient experienced raised swollen lump at injection site, muscle and joint aches, fatigue, headache and nausea, lack of appetite and energy. No treatment was received for the events. Events were reported as non-serious: did not result in death, was not life-threatening, did not cause/prolonged hospitalization, was not disabling/incapacitating and did not cause congenital anomaly/birth defect. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not pregnant. Since the vaccination, the patient has been tested for COVID-19, nasal swab on 04Dec2020: negative. Prior to vaccination, the patient was not diagnosed with COVID-19. Outcome of the events was not recovered.   Information on the lot/batch number has been requested.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Petechiae, Rash macular
Clinical narrative: I saw bright red dots &dot clusters on both legs; Petechiae; This is a spontaneous report from a contactable consumer reported for herself.  A 58-years-old female patient (not pregnant at the time of vaccination) received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), lot number: EL9262, via an unspecified route of administration on 02Feb2021 13:30 in left arm at single dose for covid-19 immunisation.  Medical history included known allergies: Amoxicillin (all penicillin family), she had AT III deficiency (a hereditary blood clotting disorder) that she had been taking warfarin for 23 years never any issues or clots since.  she had never had a reaction to any vaccines before. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19.  Concomitant medication included warfarin for AT III deficiency and 1 multi vitamin.  The patient previously took amoxicillin and experienced allergies.  On 02Feb2021 the patient got the vaccine at 1:30pm. At 5:30 pm, she saw bright red dots and dot clusters on both legs (not sure when it started, reported as 02Feb2021 05:00 PM) all dots were under the surface of her skin. They didn't itch nor hurt and were not detectable by touch. She took a few pictures. Next day they were still there and hadn't increased or decreased. The next day Thursday, she went to her PCP Dr (Name) got blood work and results came back normal. He thought it to be petechiae but not sure why. Each day the red dot/clusters turned more purple and within 5-7 days had faded away.  Dr. (Name). said if with the second vaccine dose, she got worse dot/clusters that worry her, she was to come back.  On 12Feb2021 she had an appt with her hematologist Dr (Name), after discussing and looking at the pictures (knowing that she had never had this before) she said it was not related to her medical condition-AT3 deficiency, it didn't look like petechiae. She said it was a reaction to the vaccine, to report it and get advice from you folks before got the second dose. There was no treatment received. Since the vaccination, the patient had not been tested for COVID-19. The outcome of the events was resolved in Feb2021. The events were reported as non-serious by the reporter.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling cold, Influenza like illness, Vaccination site pain
Clinical narrative: Painful left arm (where vaccinated); flu like aches; feeling cold; This is a spontaneous report from a contactable consumer reporting for herself. A 30-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), via an unspecified route of administration on 10Feb2021 at single dose in Left arm for COVID-19 immunisation. Medical history included coeliac disease from an unknown date. There were no Allergies to medications, food, or other products. The patient was not Pregnant at the time of vaccination. The patient's concomitant medications were not reported. The patient previously received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3248), on 20Jan2021 at the age of 30-year-old at single dose in Left arm for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient experienced Painful left arm (where vaccinated). She experienced flu like aches the day after vaccination as well as feeling cold on 11Feb2021. Since the vaccination, the patient had not been tested for COVID-19There was no treatment received for the adverse event. The outcome of events was recovered. The events were reported as non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Cognitive disorder, Irritability, Lymphadenopathy
Clinical narrative: swollen lymph node the size of an egg under my left arm; temp of 100.8; chills; body aches; can't comprehend conversations (needing to ask the person talking to me to repeat 2 times); getting snappy almost because they repeated it; Felt a few times while standing/walking I could all the sudden fall asleep; This is a spontaneous report received from a contactable consumer (patient).  A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264, expiry date unknown), via an unspecified route of administration on the left arm, on 09Feb2021, at single dose, for COVID-19 immunisation, at a nursing home. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC), budesonide, formoterol fumarate (SYMBICORT), and ethinylestradiol, norethisterone (ALYACEN). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EV3247, expiry date: unknown) received at age 49 years, via an unspecified route of administration on the left arm, on 19Jan2021 10:30, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 11Feb2021 at 08:00, the patient experienced "swollen lymph node the size of an egg under my left arm, I had a temp of 100.8, chills and body aches. I have felt like I can't comprehend conversations (needing to ask the person talking to me to repeat 2 times, then getting snappy almost because they repeated it) and felt a few times while standing/walking I could all the sudden fall asleep but then few minutes later I feel normal and alert again." The patient had no headache or foggy head feelings. No treatment was given for the events. The outcome of somnolence was resolved, outcome for the rest events was not resolved. The reporter assessed the events as non-serious.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Somnolence
Clinical narrative: swollen lymph node the size of an egg under my left arm; temp of 100.8; chills; body aches; can't comprehend conversations (needing to ask the person talking to me to repeat 2 times); getting snappy almost because they repeated it; Felt a few times while standing/walking I could all the sudden fall asleep; This is a spontaneous report received from a contactable consumer (patient).  A 43-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9264, expiry date unknown), via an unspecified route of administration on the left arm, on 09Feb2021, at single dose, for COVID-19 immunisation, at a nursing home. The patient medical history was not reported. The patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID-19 since the vaccination. The patient was not pregnant at the time of vaccination. Concomitant medication included cetirizine hydrochloride (ZYRTEC), budesonide, formoterol fumarate (SYMBICORT), and ethinylestradiol, norethisterone (ALYACEN). Historical vaccine included the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EV3247, expiry date: unknown) received at age 49 years, via an unspecified route of administration on the left arm, on 19Jan2021 10:30, for COVID-19 immunisation. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 11Feb2021 at 08:00, the patient experienced "swollen lymph node the size of an egg under my left arm, I had a temp of 100.8, chills and body aches. I have felt like I can't comprehend conversations (needing to ask the person talking to me to repeat 2 times, then getting snappy almost because they repeated it) and felt a few times while standing/walking I could all the sudden fall asleep but then few minutes later I feel normal and alert again." The patient had no headache or foggy head feelings. No treatment was given for the events. The outcome of somnolence was resolved, outcome for the rest events was not resolved. The reporter assessed the events as non-serious.
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Testicular pain
Clinical narrative: Pain in left testicle; This is a spontaneous report from a contactable consumer or other non hcp.   A 52-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot# unknown), via an unspecified route of administration left arm single dose on 11Feb2021 16:30 for covid-19 immunisation. No other vaccine was received in four weeks.  Medical history was none. The patient's concomitant medications were not reported. The patient experienced pain in left testicle on 12Feb2021 16:45. No treatment received. The outcome was not recovered.   Information on the lot/batch number has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Dizziness, Fatigue, Myalgia
Clinical narrative: burning pain in my left armpit/burning pain in both armpits; extreme fatigue; muscle pain; dizziness; This is a spontaneous report from a contactable consumer (patient) reported for herself. A 56-years-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number: EN9581) via an unspecified route of administration on 11Feb2021 09:00 at single dose in left arm for COVID-19 immunisation. She received the first dose BNT162B2 (lot number: EL8982) in Left arm on 22Jan2021 06:00 PM for COVID-19 immunisation. Medical history included depression, high blood pressure, thyroid disorder, obesity. The patient was allergic to codeine and pennicilian. The patient was not pregnant at the time of vaccination. Concomitant medication included fluoxetine hydrochloride (PROZAC), lisinopril, levothyroxine, bupropion hydrochloride (WELLBUTRIN), omeprazole (OMEP). The patient previously took the first dose of Shingrix (lot number: 5816001912) 50 mcg on Dec2020 in left arm for immunisation. On 12Feb2021 09:00, 24 hrs post 2nd vaccine BNT162B2, the patient experienced extreme fatigue, muscle pain, dizziness and 36 hrs after the second vaccine (12Feb2021 21:00) she also started having burning pain in her left armpit, and the next morning also burning pain in both armpits. No treatment received for the adverse event. Events outcome was recovering. Since the vaccination, the patient has not been tested for COVID-19.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: tiredness; chills; headache; achiness of joints; congestion(hard to breathe); This is a spontaneous report from a contactable consumer (patient). A 37-years-old female patient received the second dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot # EL-3247, in Workplace clinic, via an unspecified route of administration on 11Feb2021 at 23:30 (at 37 years of age) at single dose in left arm for COVID-19 immunization. The patient's medical history was not reported. The patient didn't receive any concomitant medication. The patient was not pregnant at the time of vaccination. She had received the first dose of BNT162B2 Pfizer-BioNTech COVID-19 mRNA Vaccine, Lot # EL-3247, via an unspecified route of administration on 21Jan2021 at 23:30 (at 37 years of age) at single dose in left arm for COVID-19 immunization. She was not diagnosed with COVID-19 prior to vaccination and has not been tested for COVID-19 since the vaccination. On 11Feb2021 at 20:00 (to be clarified) the patient experienced tiredness, chills, headache, achiness of joints and congestion (hard to breathe). The patient didn't receive any treatment. The reported events were resolving at the time of the report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Body temperature, Feeling abnormal, Headache
Clinical narrative: Fever 101.9; severe headache; muscle aches; joint pain; weakness; brain fog; lethargy; nausea; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at 10:30 at single dose in right arm for COVID-19 immunisation at the age of 73-year-old. Lot number was EM9810. The patient was not pregnant at the time of vaccination. Medical history included asthma, psoriasis, psoriatic arthritis, cardiac arrhythmia. Past drug history included allergy to Tetracycline. Concomitant medications included metaprolol, montelukast sodium (SINGULAR), simethicone (PEPSID), clonixin lysinate (SKELAXIN), Vitamin D. On 04Feb2021, the patient experienced fever 101.9, severe headache, muscle aches, joint pain, weakness, brain fog, lethargy, nausea. Fever and headache continue 9 days after the injection. On 11Feb2021, Covid test at one week was negative (nasal swab). The patient was treated with Tylenol.  The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has been tested for COVID-19.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Myalgia, Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: Fever 101.9; severe headache; muscle aches; joint pain; weakness; brain fog; lethargy; nausea; This is a spontaneous report from a contactable nurse (patient). A 73-year-old female patient received first dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 04Feb2021 at 10:30 at single dose in right arm for COVID-19 immunisation at the age of 73-year-old. Lot number was EM9810. The patient was not pregnant at the time of vaccination. Medical history included asthma, psoriasis, psoriatic arthritis, cardiac arrhythmia. Past drug history included allergy to Tetracycline. Concomitant medications included metaprolol, montelukast sodium (SINGULAR), simethicone (PEPSID), clonixin lysinate (SKELAXIN), Vitamin D. On 04Feb2021, the patient experienced fever 101.9, severe headache, muscle aches, joint pain, weakness, brain fog, lethargy, nausea. Fever and headache continue 9 days after the injection. On 11Feb2021, Covid test at one week was negative (nasal swab). The patient was treated with Tylenol.  The patient did not recover from the events. Prior to vaccination, the patient was not diagnosed with COVID-19; since the vaccination, the patient has been tested for COVID-19.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: BCG vaccine site/mark became red on 14Feb2021 after 2nd dose.; This is a spontaneous report from a contactable other hcp (patient). A 44-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (lot number EL9265), via an unspecified route of administration on 12Feb2021 16:45 at single dose for covid-19 immunization. Vaccine location was left arm and it was the second dose. Patient received the first dose of vaccine on 21Jan2021 05:00 PM at left arm at age of 44 years old with lot number EL1283. Patient is not pregnant at the time of vaccination. The facility type vaccine was Doctor's office/urgent care. The patient medical history was not reported. No known allergies. Patient was not diagnosed with COVID-19 prior to vaccination nor tested for COVID-19 since the vaccination. The patient didn't receive any other vaccines within 4 weeks prior to the COVID vaccine. Concomitant medication included omeprazole, levothyroxine, montelukast sodium (SINGULAIR). The patient experienced BCG vaccine site/mark became red on 14Feb2021 after 2nd dose. No itching as of now. Did not happen after 1st dose. It's been red for few hours now. There was no treatment received for the adverse event. The outcome of event was unknown. The event was reported as non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Pneumonia; This is a spontaneous report from a contactable consumer (patient) Pfizer-sponsored program. A male consumer of unknown age received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 09Feb2021 at single dose for COVID-19 immunisation. Medical history and concomitant medications were unknown. It was reported that on 02Mar2021 patient was scheduled for second shot and he will also receive Novocaine for pneumonia. The outcome of the event was unknown. Information on the lot/batch number has been requested.
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Headache, Pain, Peripheral swelling, Rash
Clinical narrative: swelled my arm up; big rash; Headaches; Aches/sore; This is a spontaneous report from a contactable consumer (patient). A 66-years-old female patient received Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) (lot# unknown) on an unspecific date at single dose for immunization. varicella zoster vaccine rge (cho) (SHINGRIX) on the same unspecific date for immunization. Medical history and concomitant drug were not reported.  Patient stated got shingrix and both pneumonia shots. One of those really swelled her arm up and gave her a big rash. She usually get sore, Headaches and aches. Outcome of the event was unknown.  Pfizer is a marketing authorization holder of [Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein)] in the country of incidence or the country where the product was purchased (if different). 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.  No follow-up attempts are needed. No further information is expected.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Headache, Rash, Vaccination site pain
Clinical narrative: chills; moderate shoulder pain at injection site/shoulder pain; severe headache for 28 hours; axillary rash under armpit/painful armpit rash; burning on injection on left arm; This is a spontaneous report from a contactable other healthcare professional (who is also the patient). A 48-year-old female patient received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL9266, expiry date unknown), intramuscular on the left arm, on 12Feb2021 16:00, at single dose, for COVID-19 immunization, at the pharmacy/drug store. The patient medical history and concomitant medications were not reported. The patient was not pregnant at the time of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. There were no allergies to medications, food, or other products. Historical vaccine includes the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EL3247, expiry date: unknown) received at age 48 years, intramuscular on the left arm, on 22Jan2021 15:45, for COVID-19 immunization and the patient experienced moderate shoulder pain on injection arm. The patient did not receive any other vaccines within 4 weeks prior to BNT162B2 vaccine. On 12Feb2021 at 16:00, the patient experienced burning on injection on left arm. On 12Feb2021 at 19:45, the patient experienced moderate shoulder pain at injection site for 24 hours and there was no shoulder pain 36 hours after the injection 14Feb2021 at 04:00; severe headache for 28 hours; and axillary rash under armpit/painful armpit rash which was still present 45 hours after the injection. On 13Feb2021 at 20:00 (reported as 28 hours after injection), the patient experienced chills which lasted for 2 hours. The patient was not tested for COVID-19 since the vaccination. No treatment was given for the events. The patient recovered from chills on 13Feb2021 at 22:00, severe headache on 13Feb2021 at 23:45, and moderate shoulder pain at injection site/shoulder pain on 14Feb2021 at 04:00. The outcome of burning on injection on left arm, axillary rash under armpit/painful armpit rash was not recovered.
Sex: U
Vaccine: FLUX
Symptoms: Malaise
Clinical narrative: Get sicker then before; Initial information was received on 14-Feb-2021 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional (under reference number: US-SA-SAC20210217000583).  This case involves an adult patient who get sicker than before (illness), while the patient received INFLUENZA VACCINE.  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious get sicker than before (illness) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  At the time of reporting, the event outcome is unknown.  There will be no information on batch number for this case.
Sex: M
Vaccine: FLUR4
Symptoms: No adverse event, Off label use
Clinical narrative: Patient is 15 and received Flublok in 2020 with no adverse event reported; Initial information received on 27-Jan-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 15 years old male patient who received flublok in 2020 with no adverse event reported (off label use), while he received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient's past vaccination includes FLUBLOK (not coded) which he received in 2019.   It was a case of actual medication error due to off label use.   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.  Information on batch number will not be available.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Incorrect dose administered
Clinical narrative: two year old male patient was inadvertently administered QUADRACEL, no AE; Initial information received on 09-Feb-2021 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a two years old male patient who inadvertently received DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] (product administered to patient of inappropriate age).  Medical history, medical treatment, concomitant medication, vaccination and family history were not provided.  On 09-Feb-2021, the patient received a 0.5 ml fourth dose of suspect DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE (lot C5772AA and expiry date: 17-Sep-2022) (Frequency: once) via an intramuscular route in the left thigh for prophylactic vaccination.  It was a case of actual medication error inappropriate age at vaccine administration (latency on same day).  Reporter relationship: health care professional (HCP) Product used: used  At the time of report 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: RAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient received second shot of Imovax 12 to 15 day later/with no AE; Initial information regarding an unsolicited valid non-serious case was received from a health Care Professional via Agency (Reference number- 00467936) and transmitted to Sanofi on 09-Feb-2021.  This case involves adult female patient who received second shot of RABIES (HDC) VACCINE [IMOVAX RABIES] 12 to 15 day later [Inappropriate schedule of product administration].  Medical history, medical treatment, vaccination, concomitant medication and family history were not provided.   On 25-Jan-2021, the patient received a first dose of suspect RABIES (HDC) VACCINE [lot number and expiry date not reported] via an unknown route at an unknown administration site for prophylactic vaccination.  This was a case of actual medication error due to Inappropriate schedule of vaccine administered (latency was on same day).  It was reported that, patient received prophylactic vaccine and had deviated from schedule. Patient who is received second pre-exposure vaccine today after having received first dose on 25-Jan -2021. Health care professional stated she had to went disconnected.  Product used : Used, Still using product : Yes.  At the time of report, no adverse event 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.  There will be no information available on the batch number for this case.
Age: 1.33
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient was vaccinated with expired vaccine ACT-HIB/No AE; Initial information regarding an unsolicited valid non-serious case received from an other health professional via Information (Reference number: 00467939) and transmitted to Sanofi on 09-Feb-2021.  This case involves a 16 month old patient who patient who received an 0.5 mL expired dose of vaccine HIB (PRP/T) VACCINE [ACT-HIB] [lot UJ28AA and expiry date: 07-Feb-2021] via an unknown route in the right thigh for prophylactic vaccination on 08-Feb-2021 [Expired product administered].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for prophylactic vaccination.; HEPATITIS A VACCINE (HEPATITIS A VACCINE) for prophylactic vaccination.; and INFLUENZA VACCINE (INFLUENZA VACCINE) for prophylactic vaccination.  It was a case of actual medication error due to expired vaccine used [Latency: on the same day].  Product used : Used.  Still using product : No.   At the time of report, 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.
Age: 0.33
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 4 month child was given the flu vaccine intended for an over 6 month child, no AE; Initial information regarding an unsolicited valid non-serious case was received from physician via Global Medical Information (Reference number- 00473707) and transmitted to Sanofi on 12-Feb-2021.  This case involves a 4 months old patient was given the INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] via unknown route in unknown administration site for prophylactic vaccination. On an unknown date (product administered to patient of inappropriate age)  Medical history, medical treatment(s), past vaccination(s) concomitant medication and family history were not provided.   It was a case of an actual medication error due to inappropriate age at vaccine administration (latency same day).  The consumer had not experienced any adverse reactions and that he was aware of and wanted to know if there were any studies about possible effects later on. He would be  needing to do an Impact Study before contacting the parents as this even though occurred 2 months ago it was just brought to his attention.  At the time of reporting, 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.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Eczema
Clinical narrative: eczema; Initial information received on 17-Feb-2021 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves female patient of an unknown age who experienced eczema, while she received vaccine DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL].  Medical history, medical treatment, vaccination and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and ROTAVIRUS VACCINE (ROTAVIRUS VACCINE) for Immunisation.  On an unknown date, the patient received a standard dose of suspect DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE (lot UJ191AAA and expiry date: 22-Feb-2022) via an unknown route in the left thigh for prophylactic vaccination.  On an unknown date, the patient developed a non-serious eczema (unknown latency) following the administration of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE.  Details of laboratory data not reported.   It was not reported if the patient received a corrective treatment.  At the time of reporting, the outcome of event was reported as unknown.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect route of product administration, No adverse event, Wrong product administered
Clinical narrative: patient was provided the vaccine intradermally or subcutaneously with no reported adverse event; Initial information was received on 18-Feb-2021 regarding an unsolicited valid non-serious case from a consumer or other non-professional via vaccine compensation program.   This case involves a patient with unknown demographics who was provided the INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE], [lot number: UI692AB, expiry date: Apr-2017] via an intradermal or a subcutaneously route at an unknown administration site on an unknown date for prophylactic vaccination (incorrect route of product administration). (Latency: on the same day)  Medical history, medical treatment, vaccination family history and concomitant medication were not reported.  It was a case of actual medication error due to inappropriate route of vaccination.  At the time of report, 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.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain, Vomiting
Clinical narrative: Severe vomiting, chills, fatigue, body aches and shakes lasting 7 days
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Welts on abdomen, upper thighs
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dry mouth, Dry throat, Dysphonia, Exposure during pregnancy
Clinical narrative: Within minutes after the vaccine I felt hot, removed my jacked but then I got chilled, my right hand begin itching which moved to the left hand.  I was taken to the ER and was administed benedryl.  I was transported to the hospital via ambulance because my mouth and throat was extremely dry and my voice got hardened.  During the ride I regurgiatated because my stomach got queezy and was administered Zofran.  My right hand turned completely white and I was administered another med to help turn my hand back right.  My baby was checked and she was fine and was released after about 3 hrs.  At that time I was 31 week gestation.  Until about 3 days ago my body was still very very itchy all over which seemed to worsen when I was sleep.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Nausea, Pruritus, Skin discolouration
Clinical narrative: Within minutes after the vaccine I felt hot, removed my jacked but then I got chilled, my right hand begin itching which moved to the left hand.  I was taken to the ER and was administed benedryl.  I was transported to the hospital via ambulance because my mouth and throat was extremely dry and my voice got hardened.  During the ride I regurgiatated because my stomach got queezy and was administered Zofran.  My right hand turned completely white and I was administered another med to help turn my hand back right.  My baby was checked and she was fine and was released after about 3 hrs.  At that time I was 31 week gestation.  Until about 3 days ago my body was still very very itchy all over which seemed to worsen when I was sleep.
Age: 82.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Chills, Fatigue, Pyrexia
Clinical narrative: weak, chills, fatigue, low-grade fever; feels worse than when he had COVID in March 2020
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Nausea, Pain
Clinical narrative: Extremely sore arm Body aches all over Severe chills  Headache Nausea Fatigue
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Extremely sore arm Body aches all over Severe chills  Headache Nausea Fatigue
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Echocardiogram, Insomnia, Laboratory test, Pain
Clinical narrative: pt stated that a couple of days after the vax he was headed to get lab work done at the hospital for a upcoming  procedure when he started having shortness of breath.  He was only able to walk about 20-30 yards and was gasping for air.  He had the procedure and went home but was not able to sleep without sitting up.   He has a C-PAP machine but has not been able to use due to having excessive mucus.  He also had some body aches and pains that have since subsided.  Pt went to the Hospital on 2/16/2021.  He was given a chest XRAY,  took blood work and was given O2.   Pt was discharged and told to FU w/ PCP and Cardiologist ASAP.  Pt took Covid Test on 2/19/2021 and is waiting for results. Pt has an appt w/ his Cardiologist on 3/17/2021 where they will and echo cardio- gram and he has also has an order to take a chest XRAY due to his SOB symptoms.  Pt starts radiation on 3/1/2021 for prostrate cancer.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Secretion discharge, X-ray
Clinical narrative: pt stated that a couple of days after the vax he was headed to get lab work done at the hospital for a upcoming  procedure when he started having shortness of breath.  He was only able to walk about 20-30 yards and was gasping for air.  He had the procedure and went home but was not able to sleep without sitting up.   He has a C-PAP machine but has not been able to use due to having excessive mucus.  He also had some body aches and pains that have since subsided.  Pt went to the Hospital on 2/16/2021.  He was given a chest XRAY,  took blood work and was given O2.   Pt was discharged and told to FU w/ PCP and Cardiologist ASAP.  Pt took Covid Test on 2/19/2021 and is waiting for results. Pt has an appt w/ his Cardiologist on 3/17/2021 where they will and echo cardio- gram and he has also has an order to take a chest XRAY due to his SOB symptoms.  Pt starts radiation on 3/1/2021 for prostrate cancer.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: 12 days after vaccine: intense hives on both upper arms, chest, both sides of face.  lasted 2 days .   Hives went away after day 14  but now have red itchy rash over body.  Hives and burning itch persist day 23 after vaccine.  My dr. referred me to dermatologist  who examined me on 2/23/21, viewed pictures of my hives, and examined my back rash.  She advised me to start double dosing on Zyrtec and to proceed with Moderna booster but to report to this site.   Zyrtec does not seem to relieve my ongoing itchy rash symptoms
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Pregnant, due date 03/27/2021; adverse event included localized reaction at site of injection, started out as dime sized red spot around site that grew to approximately 2" in diameter.  It was very itchy and painful, required Benadryl, Tylenol and cortisone cream for treatment, and lasted approximately 2 weeks after injection.  Only occurred after initial dose.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye irritation, Eye pruritus, Headache, Hyperhidrosis, Nausea
Clinical narrative: Within 30 minutes of getting vaccine I had a burning, itchy rash on arms, face and chest. I was sweating with no fever. Had a headache. My jaw hurt. My eyes burned and itched.  When standing was a little nauseous. I was seen by the Rescue EMTS  at the site.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in jaw, Rash, Rash pruritic, Skin burning sensation
Clinical narrative: Within 30 minutes of getting vaccine I had a burning, itchy rash on arms, face and chest. I was sweating with no fever. Had a headache. My jaw hurt. My eyes burned and itched.  When standing was a little nauseous. I was seen by the Rescue EMTS  at the site.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Burning sensation, Erythema, Eye irritation, Eye pruritus, Headache
Clinical narrative: Within 30 minutes of getting vaccine I had a burning, itchy rash on arms, face and chest. I was sweating with no fever. Had a headache. My jaw hurt. My eyes burned and itched.  When standing was a little nauseous. I was seen by the Rescue EMTS  at the site.
Age: 53.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hyperhidrosis, Pain in jaw, Pruritus, Rash macular
Clinical narrative: Within 30 minutes of getting vaccine I had a burning, itchy rash on arms, face and chest. I was sweating with no fever. Had a headache. My jaw hurt. My eyes burned and itched.  When standing was a little nauseous. I was seen by the Rescue EMTS  at the site.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Noticed my right arm became hot to the touch. Upon examination I noticed that it was swollen and red. Now it has started itching. Pu ice on it.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Exposure via skin contact, Needle issue, Underdose
Clinical narrative: A "few drops" of Moderna COVID 19 vaccine leaked onto patients arm due to needle and syringe not tightened enough.  RN states a few drops, a few times during administration.  Confirmed that less than 0.1 ml leaked out.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Constipation, Epistaxis, Fatigue, Nausea, Pain
Clinical narrative: Patient was tired and slept for two days after vaccine.  Then had nausea and general "blah" feeling for the next 2 1/2 weeks and had nose bleeds.  On Day 4 she did vomit.   After second shot, she complained of constipation and aching on over.  She vomited twice.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Patient was tired and slept for two days after vaccine.  Then had nausea and general "blah" feeling for the next 2 1/2 weeks and had nose bleeds.  On Day 4 she did vomit.   After second shot, she complained of constipation and aching on over.  She vomited twice.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site erythema, Injection site warmth, Pain
Clinical narrative: Redness and warmth around the injection site measuring about 2 inches in diameter persisting through 2/26/21. Fatigue, body aches all over body.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Food allergy, Joint stiffness, Pruritus, Rash, Swelling face
Clinical narrative: I received the first dose on 12/30/20 and the 2nd dose on 1/20/21.  I started have an allergic reaction after eating walnuts on 1/30/21.  I have never had reactions to nuts before.  I had swelling, itching and rash on my face.  I took Benadryl and after 32 hours, my symptoms improved. I have since avoided tree nuts.  I have also been  having wrist and finger "tightness" in both hands since 2/10. and it seems to wax and wane.  Both hands feel stiff. Prior to the vaccinations, I have had no health conditions.   I have an appointment w/ my PCP later in the month.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: very swollen lymph nodes in axilla area, very painful, took several days for swelling to go down
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Injection site pain, Nausea, Pain
Clinical narrative: soreness in injection site, body aches, tired, nausea
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Headache, chills, fever, body aches
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure decreased, Palpitations
Clinical narrative: Vaccine given in afternoon.  Patient felt heart palpitations during that night.  Blood pressure was 95/53; low for this patient.  Two hours later everything was fine.   Moderna Lot #016M20A
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue lasting about 8 hours.