chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: low grade fever; myalgia; This is a spontaneous report from a contactable physician (patient). A 35-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, batch/lot number and expiration date were unknown), via an unspecified route of administration on 22Dec2020 at a single dose on left deltoid for COVID-19 immunization. Medical history included asthma exercise induced. There were no concomitant medications. The patient experienced low grade fever and myalgia on unspecified date. Outcome of the events was unknown.   Information about lot/batch number has been requested.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling abnormal, Pharyngeal swelling
Clinical narrative: I woke and wasn't feeling good at all; Chills; My throat is little swollen and I have cough; My throat is little swollen and I have cough; This is a spontaneous report from a contactable consumer reporting for himself. A 71-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 IMMUNIZATION. Relevant medical history was none. Concomitant medication was not provided. On an unknown date, the next day after receiving the vaccination, the patient woke up and wasn't feeling good at all and had chills. On an unknown date, the patient reported that his throat was a little swollen and he has a cough. The patient received treatment for the events cough and throat swelling which included ibuprofen and oral septic for his throat. The outcome of the events wasn't feeling good at all and chills was not recovered. The outcome of the events throat is a little swollen and cough was unknown.  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Upper respiratory tract congestion, Urticaria
Clinical narrative: Experiencing like stuffy nose with her sinuses; Developed form of hive on her nose and her sinuses; feel like stuffy head; This is a spontaneous report from a contactable consumer (patient). An 82-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EL3248), via an unspecified route of administration on 18Jan2021 at single dose for covid-19 immunization. The patient medical history was not reported. Concomitant drugs includes levothyroxine sodium which reported as generic for Synthroid. The patient experienced like stuffy nose with her sinuses, developed form of hive on her nose and her sinuses; seems like her sinuses; she felt like stuffy head. The patient wanted to know is that a side effects or a normal reaction. Therapeutic measures were taken as a result of experiencing like stuffy nose with her sinuses includes like Tylenol. The outcome of the events was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Influenza like illness, Night sweats, Pain, Pyrexia
Clinical narrative: Flu like symptoms including chills, fever, night sweats, body aches; Flu like symptoms including chills, fever, night sweats, body aches; Flu like symptoms including chills, fever, night sweats, body aches; Flu like symptoms including chills, fever, night sweats, body aches; Flu like symptoms including chills, fever, night sweats, body aches; This is a spontaneous report from a contactable consumer via Sales Representative. A patient of unspecified age and gender received the second dose 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 was not reported.  The patient's concomitant medications were not reported.  The patient previously took the first dose BNT162B2 and experienced lot of arm pain. The patient experienced flu like symptoms including chills, fever, night sweats, body aches after 8 hours received vaccine. The outcome of events was unknown.  No follow-up attempts are possible, information about lot/batch number cannot be obtained.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Contacted Covid after their first vaccine; Contacted Covid after their first vaccine; This is a spontaneous report from a contactable consumer from a Pfizer-sponsored program IBCC (Inbound Call Center for HCPs). This consumer reported similar events for two patients. This is the first of two reports.  A patient (reported as: healthcare professional) of unspecified age and gender received the first dose of the bnt162b2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization.  The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced: contacted COVID after their first vaccine (medically significant). The clinical outcome of the events, drug ineffective and COVID-19, was unknown.  The batch/lot numbers for the vaccine, PFIZER-BIONTECH COVID-19 MRNA VACCINE, were not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021082538 same reporter, drugs and events.; different patient.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: On my left arm bothers me it is not a pain that I cannot tolerate but it is lot more than I had first day; This is a spontaneous report from a contactable consumer (patient). A patient of unspecified age and gender received BNT162B2 (unspecified if Pfizer product), via an unspecified route of administration at left arm in Jan2021 at single dose for COVID-19 immunization. Patient had the vaccine (unspecified vaccine) on Friday on his/her left arm it didn't bother her/him that much very little. patient knew it was there, but nothing happened but after last night patient knew have like it bothers her/him it was not a pain that she/he cannot tolerate but it was lot more than she/he had first day (Jan2021). Patient was taking paracetamol (TYLENOL). Outcome of the event was unknown.  Pfizer is a marketing authorization holder of COVID-19 VACCINE in the country of incident or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of COVID-19 VACCINE has submitted the same report to the regulatory authorities.  Information about batch/lot number has been requested.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: an excruciating headache; This is a spontaneous from a contactable consumer (patient). This 49-year-old female patient received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/lot number: EK9231), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunisation. The patient's medical history included severe chronic migraine. The patient's concomitant medications were not reported. Patient stated she got her second COVID vaccine on 18Jan2021 and she has gotten an excruciating headache in Jan2021. She has taken paracetamol (TYLENOL) and 800 mg ibuprofen on 18Jan2021 and it was actually getting worse. When probed for any treatment for the problem, patient stated yes, her headache, all she had taken for 18Jan2021 so far was paracetamol, diphenhydramine hydrochloride (BENADRYL) (if might have taken for headache) and ibuprofen. Outcome of the event was unknown. No investigation assessment.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive, X-ray
Clinical narrative: tested positive for COVID-19; tested positive for COVID-19; This is a spontaneous report from a contactable consumer, the spouse of the patient.  A 62-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EL1284), via an unspecified route of administration in the left arm on 28Dec2020 (at the age of 62-years-old) as a single dose for COVID-19 immunization.   Medical history included ongoing lupus from an unknown date. Concomitant medications included unspecified medications for her Lupus.   On 08Jan2021, the patient tested positive for COVID-19. On 18Jan2021, the patient had an X-ray with unknown results. Therapeutic measures were taken as a result of testing positive for COVID-19 and included an unspecified infusion. The clinical outcome of tested positive for COVID-19 was unknown.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site discomfort, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Right arm, where the vaccine was given, swelled up to the soft ball size; It is a reaction, hardness, warm at the patch, redness and it kept expanding; Right arm, where the vaccine was given, swelled up to the soft ball size; It is a reaction, hardness, warm at the patch, redness and it kept expanding; Right arm, where the vaccine was given, swelled up to the soft ball size; It is a reaction, hardness, warm at the patch, redness and it kept expanding; Right arm, where the vaccine was given, swelled up to the soft ball size; It is a reaction, hardness, warm at the patch, redness and it kept expanding; This is a spontaneous report from a contactable nurse (patient).   A 55 years old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EL0142/expiration date: MAR-2021) on an unspecified date  at single dose via an unspecified route of administration on deltoid Right for COVID-19 immunization.  Relevant medical history and concomitant medications were not reported. The patient reported that since an unspecified date right arm, where the vaccine was given, swelled up to the soft ball size; It was a reaction, hardness, warm at the patch, redness and it kept expanding. The patient did not receive treatment for the events. At the time of the reporting events outcome was unknown.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Tested positive after taking the first shot of the vaccine; Tested positive after taking the first shot of the vaccine; This is a spontaneous report from a Pfizer-sponsored program COVAX US Support. A Non contactable male consumer reported that a male patient of an unspecified age  received bnt162b2 (BNT162B2, Covid-19 Vaccine from Pfizer), via an unspecified route of administration on an unspecified date at SINGLE DOSE for covid-19 immunisation. The patient's medical history and concomitant medications were not reported.  The patient experienced tested positive after taking the first shot of the vaccine on an unspecified date with outcome of unknown. He wanted  to know if he can still take the second dose. He really need to know as he had been scheduled to receive his send dose tomorrow. He really need to know whether to show up or not. The patient underwent lab tests which included sars-cov-2 test: positive on unknown date.    No follow up attempts are possible. Information about Lot/ Batch could not be obtained.; Sender's Comments: Based on the information currently available, lack of efficacy of the suspected vaccine BNT162B2 cannot be completely excluded. However, individuals may not be protected until at least 7 days after their second dose of the vaccine. It is unlikely that the patient would have fully developed immunity due to the very short time lag between the first vaccine dose and the event onset.
Sex: F
Vaccine: COVID19
Symptoms: Rash vesicular
Clinical narrative: Developed a vesicular rash; This is a spontaneous report from a contactable Other HCP. A female patient of an unspecified age received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 11Jan2021 at single dose for COVID-19 vaccination. The patient's medical history and concomitant medications were not reported. The patient experienced developed a vesicular rash on 17Jan2021, it was described as 'the patient developed a vesicular rash on day 6. This was the second vaccine. It's not a diffused drug reaction like rash, it's the vesicular'. The outcome of the event was unknown. Information on the Lot/Batch number has been requested.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Contusion
Clinical narrative: Left eye is like somebody hit me on the eye; it is all bruise purple and black all over right between inside the corner of nose of the eye; This is a spontaneous report from a contactable consumer (patient). A 75-year-old male patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EK9231), via an unspecified route of administration on 18Jan2021 at single dose for COVID-19 immunization. Medical history included cholesterol. The patient was taking cholesterol medication. Nothing special other than what you get when you get older. The patient stated that he woke up this morning (19Jan2021), his left eye was like somebody hit him on the eye. It was not the eye but above the eye. It was all bruise purple and black all over right between inside the corner of nose of the eye and all away cross the top of it. He has no idea that come from. There was no treatment for the event. The outcome of the event was not recovered.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Teeth started chattering in the middle of the night; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 14Jan2021 at single dose for COVID-19 immunization. Medical history reported as none. There were no concomitant medications. The patient experienced teeth started chattering in the middle of the night in Jan2021. The patient did not receive any treatment from event. The outcome of event was unknown.  Information on the lot/batch number has been requested.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Oral pruritus
Clinical narrative: Area around her mouth is a little red and it felt itchy; Area around her mouth is a little red and it felt itchy; This is a spontaneous report from a contactable consumer (patient). A 74-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE; Lot Number and Expiration Date were not reported), via an unspecified route of administration, on 18Jan2021 at 09:15, at a single dose, for COVID-19 immunization. The patient had no medical history and concomitant medications. Yesterday morning (18Jan2021) at 9:15, the patient got her vaccine, and around 04:00 PM (also reported as 04:30 PM), yesterday afternoon, the patient started to rub the area around her mouth. And when she looked it in the mirror, it was a little red and it felt itchy. The patient took diphenhydramine hydrochloride (BENADRYL) which helped a little, just one. And the patient put some diphenhydramine hydrochloride topical cream on it also. The patient was able to sleep last night and woke up this morning and the redness is gone. It's not itchy. The patient seemed to be fine, but she doesn't know if it's from the vaccine or not. It's not one of the typical side effects. The patient asked if it is safe for her to get the vaccine (second dose) or if she needs to ask them. The patient's second dose of vaccine is scheduled on 08Feb2021. The patient recovered from the events on 19Jan2021.  Information about lot number and expiration date for the suspect product will be requested in follow-up attempts.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Hypersensitivity
Clinical narrative: Allergic reaction; She just looks all daze out; This is a spontaneous report from a contactable consumer reporting for her daughter. A female patient of an unspecified age received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on an unknown date as a single dose for COVID-19 IMMUNIZATION. Relevant medical history was not provided. Concomitant medication included she was on several medications (unspecified medications).  On an unknown date, the patient experienced an allergic reaction and she just looks all daze out. The outcome of the events allergic reaction and she just looks all daze out was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: had some dragging after the first dose; This is a spontaneous report from a contactable other-HCP (Patient)   A 56-year-old female patient received first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number: EJ1685) on 23Dec2020 at single dose intramuscular in left deltoid  for COVID-19 immunization. The patient didn't have relevant medical history or concomitant drugs. Patient reported that she may have had some dragging after the first dose, but it was after the holidays and she was laying around anyway, so if she did, it was not of note to her at the time (as reported). At the time of the reporting event outcome was unknown.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021056967 same patient/drug, different event separated with time
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: soreness at the site, more soreness than after her first shot.; This is a spontaneous report from a contactable consumer reporting for a female patient (nephew's fiance). A female patient of an unspecified age received the second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE) (lot number/expiration date: not provided), via an unspecified route of administration, on 17Jan2021 as a single dose in the left arm for COVID-19 vaccination. Relevant medical history and concomitant medication were not provided. The patient previously received the first dose of BNT162B2 on 27Dec2020 and experienced soreness at the site, fatigue, and numbness in the left pinky finger (same arm as vaccination). On an unspecified date in Jan2021, the patient experienced soreness at the site, more soreness than after her first shot. The outcome of the event soreness at the site was unknown.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort
Clinical narrative: Tightness in right side of my chest; This is a spontaneous report from a contactable consumer (patient). This 48-year-old male patient received a dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Lot number EJ1695 or EL1695 and Expiration date 31Mar2021) on 06Jan2021 (at 48 years of age) as single dose for COVID-19 immunisation.  Medical history and concomitant medication were not reported. The patient experienced tightness in right side of chest on an unspecified date. Patient called to see if this was a common event as patient was going to the hospital shortly to be sure nothing was wrong.  Outcome of event tightness in right side of chest was unknown.   The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: He felt tired and he said what he had taken; This is a spontaneous report from a contactable consumer. A male patient of an unspecified age received second dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient previously received first dose of BNT162B2 for COVID-19 immunization. It was reported that the patient talked about his experience with the first and second doses, and how the second dose affected him a bit more. He did not have a temperature, but he felt tired and he said what he had taken. The outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: M
Vaccine: COVID19
Symptoms: Headache, Myalgia
Clinical narrative: headache; some mild myalgia; This is a spontaneous report from a non-contactable physician (patient). A male patient of an unspecified age received 2nd dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on 19Jan2021 at single dose for covid-19 immunisation. The patient medical history and concomitant medications were not reported.  Patient was experiencing headache and some mild myalgia post second vaccine administration today (19Jan2021). Outcome of the event was unknown.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity
Clinical narrative: Minor headache; Sore arm; This is a spontaneous report from a contactable Other-HCP.   A  43-year-old female patient received second dose of  BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection, lot number/expiration date unknown) on 08Jan2021 at 15:30 at single dose on left deltoid/arm  via an unspecified route of administration  for COVID-19 immunization. Patient was instructed by head of infectious DZ Dept hospital to premedicate with Tylenol and Benadryl. On an unspecified date she experienced  minor headache and sore arm, without other response to second dose. At the time of the reporting event outcome was unknown.  Information about lot/batch number has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Pericarditis
Clinical narrative: pericarditis; Initial information regarding an unsolicited valid serious case was received from a other healthcare professional via Agency (Reference number- 00438099) and transmitted to Sanofi on 20-Jan-2021.  This case involves patient (unknown demographics) who experienced pericarditis, while he/she received vaccine INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE [FLUZONE].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE (lot number: UH478AC 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 serious pericarditis (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B SUBVIRION VACCINE. This event was assessed as medically significant.  Laboratory details were not reported.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pericarditis.; Sender's Comments: The patient (unknown demographics) who presented with pericarditis after vaccination with FLUZONE. The time to onset is unknown. Medical history, concomitant medication, lab data ruling out alternative etiologies would be needed for complete assessment of the case. Based upon reported information role of vaccine cannot be assessed.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site rash, Rash erythematous
Clinical narrative: arm pain at injection site & small comma rash at bottom of injection site two weeks later now have red rash area size of baseball   no pain
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain, Rash
Clinical narrative: Achy body chills headache rash on neck
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lymphadenopathy
Clinical narrative: Moderate injection site pain followed by lymphadenopathy
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Nausea, Rash
Clinical narrative: Severe Nausea as well as a sore arm was persistent for 3 days following the injection.  In addition, a rash appeared on the left side of my back and left thigh.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Amnesia, Cough, Decreased appetite, Depression, Diarrhoea
Clinical narrative: Full blown flu symptoms. Fever, aches, cough, head conjestion, exhaustion, memory loss, depression, loss of appetite, diarrhea. Missed 5 days of work
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Head discomfort, Impaired work ability, Pain, Pyrexia
Clinical narrative: Full blown flu symptoms. Fever, aches, cough, head conjestion, exhaustion, memory loss, depression, loss of appetite, diarrhea. Missed 5 days of work
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Full blown flu symptoms. Fever, aches, cough, head conjestion, exhaustion, memory loss, depression, loss of appetite, diarrhea. Missed 5 days of work
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Incorrect route of product administration, Pain in extremity, Peripheral swelling, Skin mass
Clinical narrative: Back side of arm has been progressively getting redder; Swollen; Painful; A big raised lump on back of her arm; Thinks she received the vaccine subcutaneously; A spontaneous report was received from a pharmacist concerning a female patient who received Moderna's Covid-19 vaccine (mRNA-1273) and thinks she received the vaccine subcutaneously, back side of arm has been progressively getting redder, swollen, and painful and a big raised lump on back of her arm.  The patient's medical history was not provided. Concomitant product use was not provided.  On 08 J an 2021 The patient received their first of two planned doses of mRNA-1273 for prophylaxis of COVID-19 infection Lot # 012L20A.   On an unknown date the patient's back of arm was progressively getting redder, swollen and painful. The pharmacist stated, "it looks like a big raised lump on back of her arm". Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was not provided.   The event, thinks she received the vaccine subcutaneously, was considered resolved on 08 Jan 2021.  The events, back side of arm has been progressively getting redder, swollen, and painful and a big raised lump on back of her arm, was considered unknown.; Reporter's Comments: This regulatory report concerns a female patient who experienced thinks she received the vaccine subcutaneously (inappropriate route of vaccine administered), back side of arm has been progressively getting redder, swollen, and painful and a big raised lump on back of her arm.  The event occurred following the administration of the first dose of the vaccine mRNA-1273 vaccine (Lot #: 012L20A, expiration date-unknown). Treatment administered was not reported and outcome was unknown. Based on the information provided which includes a strong temporal association and the absence of any other etiology,  the events of  back side of arm has been progressively getting redder, swollen, and painful and a big raised lump on back of her arm, a causal association with the vaccine administration cannot be excluded.  The event of inappropriate route of vaccination is considered not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Syringe issue
Clinical narrative: A needle went into the arm of a patient and needle fell off the syringe; A spontaneous report was received from a nurse, concerning a patient of an unspecified age and gender who received Moderna's COVID-19 vaccine (mRNA-1273) and the needle went into the arm of a patient and the needle fell off the syringe  There were no medical history and concomitant medications provided.  On an unknown date, the patient received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection.   The reporter stated that a needle went into the patient's arm and the needle fell off the syringe. Both the needle and syringe were discarded, and the patient was vaccinated with a new needle a syringe. Treatment information was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The outcome of the event, a needle went into the arm of a patient and needle fell off the syringe was considered resolved.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot number: not provided) for prophylaxis of COVID-19 infection and a needle went into the arm of a patient and the needle fell off the syringe. There we no reported adverse events after the vaccine was administered in this case of syringe issue.; Sender's Comments:
Sex: F
Vaccine: COVID19
Symptoms: Incorrect route of product administration
Clinical narrative: Got the vaccine subcutaneous/intradermaly; A spontaneous report was received from a 52-year old, female nurse who received Moderna's COVID-19 vaccine (mRNA-1273) subcutaneously/intradermally.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 20 Jan 2021, the patient received their first dose of two planned doses of MRNA-1273 (Lot Number: 039K20A) subcutaneously/intradermally in the right deltoid zone for prophylaxis of COVID-19 infection.  On 20 Jan 2021, the nurse received the mRNA-1273 vaccine subcutaneously/intradermally. No treatment for the event was provided.  Action taken with mRNA-1273 in response to the event was not reported.  The outcome of the event, she got the vaccine subcutaneously/intradermally was considered resolved on 20 Jan 2021.; Reporter's Comments: This case concerns a 52 year old female nurse who received her first dose of two planned doses of MRNA-1273 (Lot Number: 039K20A) subcutaneously/intradermally in the right deltoid zone for prophylaxis of COVID-19 infection. There were no reported adverse events associated with the event of incorrect route of product administration.
Sex: F
Vaccine: COVID19
Symptoms: Device connection issue, Incorrect dose administered
Clinical narrative: Patient was receiving the 1st dose and the needle broke away from the syringe; Vaccine leaked on the floor, not sure if patient received any vaccine; A report was received from a pharmacist concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and the needle breaking away from the syringe and vaccine leaking on the floor.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 25 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection.   The reporter that they vaccinated a patient with the first dose and the needle broke away from the syringe, the vaccine leaked on the floor, and they were not sure if the patient received any vaccine. No treatment information was provided.   Action taken with mRNA-1273 in response to the event was not reported.   The outcome of the event was considered resolved.; Reporter's Comments: This case a concerns a patient who received the first of two planned doses of mRNA-1273 (Lot number unknown) intramuscularly for prophylaxis of COVID-19 infection and experienced the needle broke away from the syringe, the vaccine leaked on the floor, and they were not sure if the patient received any vaccine. There we no reported adverse events after vaccine was administered.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered
Clinical narrative: Vial was punctured for over two weeks; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 Vaccine (mRNA-1273) after the vial was punctured for over two weeks.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On an unknown date, the patient received the second of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection.   On the unknown date, the vaccine administration facility had administered the second dose of the Moderna COVID-19 vaccine to the patient. After they administered the dose, the facility realized that the same COVID-19 vaccine vial had not been properly stored or disposed of after it was previously punctured. The vial had been expired for about 2 weeks. No treatment information was provided.   The patient received both scheduled doses of mRNA-1273 prior to the event, therefore action taken with the drug in response to the event was not applicable.   The event, vial was punctured for over two weeks, was considered resolved.; Reporter's Comments: This case concerns a patient who received the second of two planned doses of mRNA-1273 (Lot number: 041L20A) intramuscularly for prophylaxis of COVID-19 infection and vial was punctured for over two weeks. There were no reported adverse events after the vaccine was administered associated with the event of out of specification product use.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Epistaxis
Clinical narrative: nose bleed; This is a spontaneous report from a contactable consumer (patient's daughter). An elderly 79 years old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot/batch number and expiry date were not provided) solution for injection, via an unspecified route of administration on 17Jan2021 at a single dose for Covid-19 immunization. The patient's medical history was not reported. Concomitant medications includes Aspirin. The reporter informed that her father (patient) received the first dose of the COVID-19 vaccine yesterday (17Jan2021) and today (18Jan2021), he experienced nose bleed. The patient had a nose bleed which lasted for a pretty long time. The patient just tried to stop it in a regular way. Just pinching the nose and stuff like that. The reporter did not know if there is any other medication that he takes only the Aspirin. The reporter just wanted to know if this was normal side effect. Outcome of the event was unknown.  Information on the lot/batch number has been requested.  Follow-up (18Jan2021): New information received from a contactable consumer (patient's daughter) included: concomitant drug, event details.   Information on the lot/batch number has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: A patient has received the first dose of the vaccine and his second dose is due tomorrow. 4 days ago the patient tested positive and is nonsymptomatic; A patient has received the first dose of the vaccine and his second dose is due tomorrow. 4 days ago the patient tested positive and is nonsymptomatic; This is a spontaneous report from a contactable nurse. A patient of unspecified age and gender received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) lot number and expiration date unknown, via an unspecified route of administration on an unspecified date at a single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. The patient has received the first dose of the vaccine and his second dose was due tomorrow (19Jan2021). 4 days ago (14Jan2021), the patient tested positive for Covid test and was not symptomatic. The doctor asked to call the company to see if it was alright to give the second dose. The outcome of the event was unknown.  Information on the Batch/Lot number has been requested.; Sender's Comments: A causal association between BNT162B2 and the reported events cannot be excluded based on a compatible temporal relation. However, full immunity is only expected 2 weeks after the second dose.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Fall, Haemorrhage, Head injury
Clinical narrative: hit was head and it was bleeding; hit was head and it was bleeding; dizzy; fell; Nauseous; This is a spontaneous report from a contactable consumer (Husband). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 18:00 on Arm left at single dose (Lot # EL3249) for covid-19 immunisation. Medical history and concomitant medications were none. He did fine right after, his arm wasn't sore, he felt fine. The next day he had nothing, no soreness, nothing, he felt great the next day. Dizziness started in the morning 17Jan2021 when he got up he said good morning and then said he would bring her back a cup coffee then he became very dizzy and leaned against the wall for support and then he fell, he was okay but he fell. He did go the emergency room because he fell and hit was head and it was bleeding. They told him it was not related to the vaccine but it is one of the things that are on the form that could happen. She says it was okay if it caused it she is just looking for a reason.  Now today (18Jan2021) he feels fine she wants to know what causes that side effect. She says she is supposed to be getting her vaccine too. He had one bad dizzy spell and then it went away, and she thinks he got kind of nauseous with it. It says this can happen, it said it could happen right after but in his case it did not, it happened within probably 34 hours or something. Outcome of the event dizziness has recovered completely at this point. Outcome of other events was unknown.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: hit was head and it was bleeding; hit was head and it was bleeding; dizzy; fell; Nauseous; This is a spontaneous report from a contactable consumer (Husband). An 81-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 15Jan2021 18:00 on Arm left at single dose (Lot # EL3249) for covid-19 immunisation. Medical history and concomitant medications were none. He did fine right after, his arm wasn't sore, he felt fine. The next day he had nothing, no soreness, nothing, he felt great the next day. Dizziness started in the morning 17Jan2021 when he got up he said good morning and then said he would bring her back a cup coffee then he became very dizzy and leaned against the wall for support and then he fell, he was okay but he fell. He did go the emergency room because he fell and hit was head and it was bleeding. They told him it was not related to the vaccine but it is one of the things that are on the form that could happen. She says it was okay if it caused it she is just looking for a reason.  Now today (18Jan2021) he feels fine she wants to know what causes that side effect. She says she is supposed to be getting her vaccine too. He had one bad dizzy spell and then it went away, and she thinks he got kind of nauseous with it. It says this can happen, it said it could happen right after but in his case it did not, it happened within probably 34 hours or something. Outcome of the event dizziness has recovered completely at this point. Outcome of other events was unknown.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Gastrooesophageal reflux disease, Headache, Pain
Clinical narrative: cannot hold anything down her stomach/ what she did eat came back up; bad headaches; bad aches; This is a spontaneous report from a contactable consumer (patient). A 29-years-old female patient started to receive the 1st dose BNT162B2 (PFIZER-BIONTECH COVID-19, lot number: EH9899), via an unspecified route of administration at right arm muscle on 12Jan2021 in the morning about 9:30AM or 10:00AM at single dose for COVID-19 immunization. Medical history was reported as none. The patient's concomitant medications were not reported. The patient had not had a vaccine before vaccination. The patient was experiencing bad aches in Jan2021, bad headaches started 15Jan2021 about 17:30, Friday evening when she got off work and cannot hold anything down her stomach when she got up about 8:00 on 16Jan2021. What could she take to settle her stomach. She didn't each much at all, but what she did eat came back up. She was scared to eat something at the moment. She was just lost. She went to the Emergency Room on 16Jan2021, but it was a long wait so she went home. The outcome of events bad headaches and cannot hold anything down stomach was not recovered, of the other event was unknown. She wanted to know what she should take for these side effects and if the 2nd dose was optional. She wanted to know if she would feel better after the 2nd dose of the vaccine. She also wants to know if it was possible for her kids to get the virus if she was having the side effects, how long does the Pfizer-BioNTech Covid-19 Vaccine remain in the system. It was not reported as serious.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Lymphangitis
Clinical narrative: Lymphangitis of left underarm, swollen out to size of softball; administration date=16Jan2021/ 31Dec2020; This is a spontaneous report from a contactable other HCP(patient).  A 37-year-old male patient received second dose BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot: EK4176), via an unspecified route of administration at left arm on 16Jan2021 16:45 at single dose for COVID-19 immunization.  Medical history included gastrooesophageal reflux disease(GERD), insomnia. There was no Known allergies.  Concomitant medication included zolpidem tartrate (AMBIEN), pantoprazole sodium sesquihydrate (PROTONIX). There was no other vaccine in four weeks. Patient previously first dose BNT162B2(lot number=EK5730) on 31Dec2020, 19:00 at Left arm at single dose for COVID-19 immunization.   The patient experienced Lymphangitis of left underarm, swollen out to size of softball on 18Jan2021 10:00, occupational health advised to get seen,went to Emergency room, urgent care recommended paracetamol (TYLENOL)for swelling and no anti-inflammatories that may hinder the immune process. Treatment paracetamol was received. Outcome of the event was recovering. There was no covid tested post vaccination.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "Lymphangitis of left underarm, swollen out to size of softball" and the administration of COVID 19 vaccine, BNT162B2, based on the reasonable temporal association and lacking alternative explanations.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Product substitution issue
Clinical narrative: Received a Moderna vaccine at another clinic 12/30/20. 1/27/2021 he received a Pfizer vaccine at clinic
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Dysentery, Hyperhidrosis, Malaise, Pyrexia
Clinical narrative: Fever to 101.7 body weakness sweats dysentery feeling of malaise, duration ran 48 hours
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Injection site erythema, Paraesthesia
Clinical narrative: Intermittent tingling/numbness to left arm after vaccine x 8 days after.   Intermittent tingling/numbness to left leg after vaccine x 8 days after.   Noticed small erythematic area 3 cm x 3 cm around injection site.  ED MD noted, no cellulitis.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vertigo positional
Clinical narrative: For informational purposes, I am a health care provider myself. I have been experiencing severe episodes of vertigo, starting approximately 1 week after receiving my first dose of the Pfizer vaccine, and only when lying in bed. They occur a few times per night, and have occurred essentially every night since they started. They are very intense, but also very short in duration, of about 3-5 seconds. When I called my primary care physician to see if she had any thoughts, or suggestions, or if she thought it could be due to the vaccine, she informed me that she also had the same reaction, severe vertigo, while lying in bed, at about the same time period, 1 week after her first injection, although she just had 2 isolated episodes of it, and she had the Moderna vaccine. Neither of us have seen any published information listing this as a side effect of the vaccine.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: bilateral hip joint pain
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: ?Moderna COVID-19 Vaccine EAU?  Fever and chills for 1 day and sore arms for 3-4 days  Took tylenol for the fever  and cold compress for the sore arms.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: 8 days after my 1st vaccination, I woke up to the injection site being swollen, hot, red & extremely itchy.  The swelling is about 2-3 inches in diameter.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Death, Posture abnormal
Clinical narrative: passed away; cough; This is a spontaneous report from a contactable consumer, the patient's daughter.  A 92-year-old female patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the left arm on 13Jan2021 at 11:00 (at the age of 92-years-old) as a single dose for COVID-19 immunization.   Ongoing medical history included nursing home resident, admitted to hospice on 13Jan2021 (prior to vaccination), and oxygen supplementation (due to low oxygen levels) from a few days prior to the vaccine (Jan2021). Other relevant medical history included congestive heart failure from Dec2020 and sulfa allergy. Prior to the vaccination, the patient was tested numerous times (as reported) for COVID-19 and was negative.  There were no concomitant medications. The patient did not receive any other vaccines within four weeks prior to the vaccination. A few days before the vaccination, her oxygen level had gone down, and she had been placed on oxygen. Prior to receiving the vaccine, the patient was reported as being 'fine'. On 13Jan2021, the patient received the vaccine at 11:00. The patient coughed maybe 5 or 6 times and then dropped her head. Resuscitation was not performed as patient had a do not resuscitate (DNR) order. The patient passed away on 13Jan2021 at 13:05. The cause of death was not reported. An autopsy was not performed. The clinical outcome of the cough was unknown at the time of death.     The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.; Reported Cause(s) of Death: passed away
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Diarrhoea, Dizziness, Feeling abnormal, Syncope
Clinical narrative: faint; dizzy; funny taste in mouth; urine issues; diarrhea; upset stomach; feeling abnormal; This is a spontaneous report from a contactable consumer. This consumer reported same events for two patients (one is patient self). This is the second of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced faint, dizzy, funny taste in mouth, urine issues, diarrhea, upset stomach, feeling abnormal. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021044692 Same reporter/ vaccine/ AEs, different patient
Sex: U
Vaccine: COVID19
Symptoms: Taste disorder, Urinary tract disorder
Clinical narrative: faint; dizzy; funny taste in mouth; urine issues; diarrhea; upset stomach; feeling abnormal; This is a spontaneous report from a contactable consumer. This consumer reported same events for two patients (one is patient self). This is the second of two reports. A patient of unspecified age and gender received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), via an unspecified route of administration on an unspecified date in Jan2021 at single dose for COVID-19 immunization. The patient's medical history and concomitant medications were not reported. In Jan2021, the patient experienced faint, dizzy, funny taste in mouth, urine issues, diarrhea, upset stomach, feeling abnormal. The outcome of event was unknown.  Information on the lot/batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021044692 Same reporter/ vaccine/ AEs, different patient