chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Product preparation error
Clinical narrative: Received shot, vial (with) ice crystals in it; A spontaneous report was received from a consumer concerning a 68 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced received shot, vial (with) ice crystals in it.   The patient's medical history was not reported.  Relevant concomitant medications were reported included Cholesterol medication.  On 28th Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 010M20A) intramuscularly for prophylaxis of COVID-19 infection. The vaccine was administered from a vial with ice crystals that supervisor said was no good. Patient noted she has had no side effects or sore arm after administration. No treatment information was provided.    Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the event vaccine was administered from a vial with ice crystals that supervisor said was no good was considered resolved on 28 Jan 2021.; Reporter's Comments: This report refers to a case of product preparation issue for mRNA-1273 (lot # unknown)  with no associated AEs reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure systolic, Computerised tomogram, Dizziness, Echocardiogram
Clinical narrative: Heart was pounding and racing; Blood pressure was erratic; Dizziness; Bilateral weakness in my legs; Sore arm; A spontaneous report  was received from a heath care professional concerning a 56 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm/pain in extremity, dizziness, heart was pounding and racing/ palpitations, bilateral weakness in legs/muscular weakness and blood pressure was erratic/blood pressure fluctuation.  The patient's medical history included COVID-19. No relevant concomitant medications were reported.    On 21 Jan 2021, 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced sore arm that lasted for 2 days.  On 24 Jan 2021, at 2 PM the patient had dizziness and her heart was pounding and racing. She stood up and felt like she was going to fall due to bilateral weakness in her legs and was taken by ambulance to the hospital. She was given medication to control her BP because it was erratic.   On 27 Jan 2021, the patient was released from the hospital.  Laboratory details as reported by the reporter include systolic blood pressure (BP) of 215, electrocardiogram (ECG), echocardiogram, computerized tomography scan (CT), magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) to check for transient ischemic attack (TIA), depleted oxygen to the brain, and circulation problems. All tests performed came back as normal.  Treatment for the events included unspecified blood pressure medication.    Action taken with mRNA-1273 in response to the events was not reported.   The event, sore arm, was considered resolved on 24 Jan 2021. The events, dizziness, heart was pounding and racing, bilateral weakness in legs and blood pressure was erratic, were considered resolved on 27 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Electrocardiogram, Magnetic resonance imaging, Muscular weakness, Pain in extremity, Palpitations
Clinical narrative: Heart was pounding and racing; Blood pressure was erratic; Dizziness; Bilateral weakness in my legs; Sore arm; A spontaneous report  was received from a heath care professional concerning a 56 year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm/pain in extremity, dizziness, heart was pounding and racing/ palpitations, bilateral weakness in legs/muscular weakness and blood pressure was erratic/blood pressure fluctuation.  The patient's medical history included COVID-19. No relevant concomitant medications were reported.    On 21 Jan 2021, 1 day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch: 012L20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On 22 Jan 2021, the patient experienced sore arm that lasted for 2 days.  On 24 Jan 2021, at 2 PM the patient had dizziness and her heart was pounding and racing. She stood up and felt like she was going to fall due to bilateral weakness in her legs and was taken by ambulance to the hospital. She was given medication to control her BP because it was erratic.   On 27 Jan 2021, the patient was released from the hospital.  Laboratory details as reported by the reporter include systolic blood pressure (BP) of 215, electrocardiogram (ECG), echocardiogram, computerized tomography scan (CT), magnetic resonance imaging (MRI) and magnetic resonance angiography (MRA) to check for transient ischemic attack (TIA), depleted oxygen to the brain, and circulation problems. All tests performed came back as normal.  Treatment for the events included unspecified blood pressure medication.    Action taken with mRNA-1273 in response to the events was not reported.   The event, sore arm, was considered resolved on 24 Jan 2021. The events, dizziness, heart was pounding and racing, bilateral weakness in legs and blood pressure was erratic, were considered resolved on 27 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.  Further information has been requested.
Sex: U
Vaccine: COVID19
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Syringe came apart; Suspension ran down arm; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a syringe issue and incomplete dose.    The patient's medical history was not reported. No Relevant concomitant medications were reported.  On 26th Jan 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 intramuscularly for prophylaxis of COVID-19 infection.   On date 26th Jan 2021, during administration one of the syringes came apart and some of the suspension ran down the patient's arm. Vaccine leaked and patient didn't receive much of the 2nd dose possibly.    No treatment information was provided.    The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable.   The outcome of the event syringe issue and incomplete dose administered was considered Recovered/Resolved on 26 Jan 2021.; Reporter's Comments: This report refers to a case of syringe issue (comes apart during vaccine administration), and incomplete dose for mRNA-1273, (lot # not provided)  with no associated AEs.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Vaccination site mass, Vaccination site pain, Vaccination site swelling
Clinical narrative: Swollen at the injection site; Lump on Left Arm; Left arm was painful /it was painful to the touch/it more like a numb dull pain; This is a spontaneous report from a contactable consumer, the patient. A 78-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 MRNA VACCINE; Lot Number EL3246; Expiration Date 28Jan2021), via an unspecified route of administration in the left arm on 26Jan2021 12:15 (at the age of 78-years) as a single dose for COVID-19 immunization. There was a no medical history. The patient's concomitant medications were not reported. The patient received the vaccine on 26Jan2021 and in the evening her left arm was painful, she could not sleep on the arm. On 27Jan2021, before she took a bath, she still had the band aid on and it was still hurting a little, the area was swollen at the injection site, it was painful to the touch, she could feel a lump on the left arm, she still could not sleep on the arm. On 28Jan2021 the swelling went down and was still painful, but it was not a sharp pain, it more like a numb dull pain, she was calling to ask if that is normal. The patient treated herself with paracetamol (TYLENOL) prophylactically 2 hours prior to vaccination and on an unspecified date rubbed some alcohol on the injection site. The swelling was reported as just a little. The lump was completely gone but she still felt the dull pain. The clinical outcome of the event left arm was painful and swollen at the injection site was recovering; and lump on the left arm was recovered on 27Jan2021.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Decreased appetite, Headache, Hyperhidrosis
Clinical narrative: decreased appetite; Sweats; Chills; fever (101.3); headache; Body aches; This is a spontaneous report from a contactable Other-HCP (patient) and another other-HCP. This 26-year-old female received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL0142, intramuscular in left arm on 11Jan2021 at 07:00 as single dose (at the age of 26 years) for Covid-19 Immunization.  Relevant medical history was reported as none and concomitant medication was not reported.  The patient had historical vaccine on 21Dec2020 at the age of 26 years of BNT162B2 for Covid-19 immunization and experienced Onset of body aches 12 hours after vaccination and lasted for 24 hours. (Lot Number/Expiry Date: EH9899, Route: intramuscular).  The patient experienced Body aches, headache, fever, chills, sweats on 11Jan2021 18:00 and recovered on 13Jan2021. Patient received Tylenol extra strength 100mg on 11Jan2021 for symptoms.  Patient experienced decrease appetite on unspecified date with outcome of unknown.  The other HCP consider the Pfizer product had a causal effect to the adverse event.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: decreased appetite; Sweats; Chills; fever (101.3); headache; Body aches; This is a spontaneous report from a contactable Other-HCP (patient) and another other-HCP. This 26-year-old female received dose 2 of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) Lot number EL0142, intramuscular in left arm on 11Jan2021 at 07:00 as single dose (at the age of 26 years) for Covid-19 Immunization.  Relevant medical history was reported as none and concomitant medication was not reported.  The patient had historical vaccine on 21Dec2020 at the age of 26 years of BNT162B2 for Covid-19 immunization and experienced Onset of body aches 12 hours after vaccination and lasted for 24 hours. (Lot Number/Expiry Date: EH9899, Route: intramuscular).  The patient experienced Body aches, headache, fever, chills, sweats on 11Jan2021 18:00 and recovered on 13Jan2021. Patient received Tylenol extra strength 100mg on 11Jan2021 for symptoms.  Patient experienced decrease appetite on unspecified date with outcome of unknown.  The other HCP consider the Pfizer product had a causal effect to the adverse event.
Sex: U
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: slightly sore arm; Initial information received on 15-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-healthcare professional via social media.  This case is linked to case 2020SA292550 (same reporter).  This case involves patient (unknown demographics) who experienced slightly sore arm (pain in extremity), while he/she received vaccine INFLUENZA VACCINE.  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided. The patient had no medical history, concomitant disease or risk factor.   On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious slightly sore arm (pain in extremity) (unknown latency) following the administration of INFLUENZA VACCINE.  Patient is reporting that That is definitely a myth. Nothing in INFLUENZA VACCINE to give the flu.  It is unknown if the patient experienced any additional symptoms/events.  There were no lab data/results available.   It was not reported if the patient received a corrective treatment.  The event outcome was unknown for pain in extremity.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Every time patient take flu shot he/she got the flu; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious social media case from a consumer via.  This case involves an adult patient who got the flu (influenza), while he/she received vaccine INFLUENZA VACCINE.  Medical history, past medical treatments, past vaccinations, 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 expiration date were not reported) via unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient got a non-serious flu (influenza), (unknown latency) following the administration of INFLUENZA VACCINE.  The reporter asked that Why? Every time he/she take it he/she get the flu, worse then if did not take.  Laboratory data was not reported.  It was not reported if the patient received any corrective treatment or not.  The outcome of the event was unknown at the time of reporting.  There will be no information on the batch number for this case.
Sex: M
Vaccine: FLUX
Symptoms: COVID-19, Malaise, SARS-CoV-2 test positive
Clinical narrative: feeling ill; tested positive for COVID; Initial information received on 10-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional via social media.  This case involves male patient (age not reported) who experienced feeling ill (malaise) and tested positive for (Covid-19) , while he received vaccine INFLUENZA VACCINE.  The patient's past medical treatment, vaccination, concomitant medication and family history were not provided. It is unknown if the patient had any medical history, concomitant disease or risk factor.    On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious feeling ill (malaise) and tested positive for (Covid-19) (unknown latency) following the administration of INFLUENZA VACCINE.  Relevant laboratory test results included: SARS-CoV-2 test - On an unknown date: Positive  It is unknown if there were lab data/results available.  It was not reported if the patient received a corrective treatment.  The event outcome was unknown for both the events.  There will be no information available on the batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Peripheral swelling
Clinical narrative: flu shot cause my arm swell; Initial information was received on 14-Oct-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional via social media (under reference number: US-SA-SAC20210219000557).  This case involves an adult patient who experienced flu shot cause my arm swell (peripheral swelling), 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 flu shot cause my arm swell (peripheral swelling) unknown latency following the administration of INFLUENZA VACCINE.  Details of laboratory data were not reported.  It was not reported if the patient received a corrective treatment.  At the time of reporting, the event outcome is unknown.  There will be no information on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Rhinorrhoea, Vaccine positive rechallenge
Clinical narrative: sniffles every time; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional via social media.  This case involves a patient of unknown age and gender who experienced sniffles every time (rhinorrhoea), while he/she received vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor and the patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported.   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 non-serious sniffles every time (rhinorrhea) (Unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events. Medication details and reason for taking the medicine: Product Name: Product name was not provided. Since this was a public post it was assumed the consumer was referring to the Sanofi flu vaccine.  Details of laboratory data were not reported.  Patient was treated with mild antibiotic.  At the time of reporting, outcome of the event was unknown.  Result of assessment was not reported.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Malaise, Peripheral swelling
Clinical narrative: arm was swell; sick; Initial information was received on 15-Oct-2020 regarding an unsolicited valid non-serious case received from a consumer or non-health care professional via media.  This case is linked with case 2020SA292550.  This case involves an adult patient exact age unknown and gender unspecified whose arm was swell (peripheral swelling) and sick for two weeks (illness), while he/she received vaccine INFLUENZA VACCINE.  It was unknown if the patient had any medical history, concomitant disease or risk factor and the patient's past medical treatment(s), vaccination(s), family history and concomitant medication were not reported   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 in 2002, the patient's arm was swell (peripheral swelling) and sick for two weeks (illness) (Unknown latency) following the administration of INFLUENZA VACCINE.  It was unknown if the patient experienced any additional symptoms/events. Medication details and reason for taking the medicine: Product Name: Product name was not provided. Since this was a public post on the Sanofi flu shot campaign it was assumed that the consumer was referring to the Sanofi flu vaccine.   Details of laboratory data were not reported.  It was not reported if the patient received any corrective treatment.  On an unknown date, patient had recovered from the events.  There will be no information available on batch number for this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza, Vaccine breakthrough infection
Clinical narrative: patient only had the flu a few years back; Initial information received on 21-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/ non-health care professional via social media.  This case involved a patient of unknown age who got the flu (influenza), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (few years back), patient got the flu (influenza), (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown.  There will be no information available regarding batch number in this case.
Sex: U
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: patient got the flu really bad; Initial information received on 23-Feb-2021 regarding an unsolicited valid non-serious case received from a consumer/ non-health care professional via media.  This case involved a patient of unknown age who got the flu really bad (influenza), while patient received vaccines INFLUENZA VACCINE.  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications were not reported.  On an unknown date, the patient received INFLUENZA VACCINE [lot number: unknown and expiration date: unknown] at an unknown dose via unknown route in an unknown administration site for prophylactic vaccination.  On an unknown date (20 years ago), patient got the flu really bad (influenza), (latency: unknown) following the administration of suspect vaccine.  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  Outcome of the events were unknown.  There will be no information available regarding batch number in this case.
Sex: F
Vaccine: FLU3
Symptoms: Depressed mood
Clinical narrative: down; Initial information regarding an unsolicited valid non-serious case was received from a consumer/non-healthcare via inbound (reference number-00481707) and transmitted to Sanofi on 18-Feb-2021.  This case involves a female patient (age unspecified) who was down (depressed mood), while she received INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient was down (depressed mood) (unknown latency) following the administration of INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE, for 14 weeks.  The reporter wanted to know the ingredients of the 2016 formulation of FLUZONE HD (high dose)  No laboratory data was reported.  It was not reported if the patient received a corrective treatment.  On an unknown date, the event recovered.  There will be no information available on the batch number for this case.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Syncope, Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Additional Details: Patient fainted for a brief moment after he received the COVID vaccine. Called 911 to have him checked out.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Myalgia
Clinical narrative: Severe muscle aches and fatigue for 48 hours
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Chills, Dysphagia, Dyspnoea, Flushing
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Hypersensitivity, Nausea, Tachycardia, Throat tightness
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Systemic: Allergic: Anaphylaxis-Medium, Systemic: Allergic: Difficulty Breathing-Mild, Systemic: Allergic: Difficulty Swallowing, Throat Tightness-Mild, Systemic: Chills-Mild, Systemic: Flushed / Sweating-Medium, Systemic: Nausea-Medium, Systemic: Shakiness-Medium, Systemic: Tachycardia-Medium
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling hot, Flushing, Hyperhidrosis, Hypotension, Syncope
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: @~1415 HR 63 BP 118/58; @~1430 BP128/92; @~1445 HR 71 BP: 127/87; Pt had gotten up to walk around store (stated she hadn't had an allergic reaction or fainted with a vaccine before), came back within 5 min and stated she was feeling hot, temp was 96.8. I asked pt to sit down and on her way over she fainted; denied hitting her head, only her arm. Responded almost immediately, proceeded to take vitals and monitored.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Fainting / Unresponsive-Mild, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild, Additional Details: @~1415 HR 63 BP 118/58; @~1430 BP128/92; @~1445 HR 71 BP: 127/87; Pt had gotten up to walk around store (stated she hadn't had an allergic reaction or fainted with a vaccine before), came back within 5 min and stated she was feeling hot, temp was 96.8. I asked pt to sit down and on her way over she fainted; denied hitting her head, only her arm. Responded almost immediately, proceeded to take vitals and monitored.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Mobility decreased, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Muscular soreness in upper arm traveling up to shoulder and back of neck.  No swelling or rash but it's too the point where I can't lift my arm.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Error: Wrong Dose of Vaccine - Too High
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Headache  Fever Loss of Appetite  Lethargic  Neausea Swelling at injection site Pain at injection site
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia
Clinical narrative: Headache  Fever Loss of Appetite  Lethargic  Neausea Swelling at injection site Pain at injection site
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Flushing, Hyperhidrosis, Hypotension, Syncope
Clinical narrative: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Unresponsive to stimuli
Clinical narrative: Systemic: Allergic: Anaphylaxis-Mild, Systemic: Fainting / Unresponsive-Medium, Systemic: Flushed / Sweating-Mild, Systemic: Hypotension-Mild
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Diarrhoea
Clinical narrative: Sore shoulder that day, next day in afternoon started having diarrhea for two days in a row.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: "63 yo female with 1 week h/o skin lesions as described below. Received 2nd SHINGRIX vaccine on 2/15. All symptoms have resolved except for rashes. Itchy lesion on L thigh, size of palm of hand. Also involved hand and 3 areas on face. No breathing difficulty or facial/throat swelling."
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pain of skin, Peripheral swelling, Pruritus
Clinical narrative: Approx 12 days after receiving my first dose of the vaccine my right arm was sore to the touch, a little itching. By 2/28 it is hot to the touch, swollen, red and hurts. I will be going into the doctor to have them take a look at it since it has been 2 weeks since I received the vaccine as of today 3/1.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Skin warm
Clinical narrative: Approx 12 days after receiving my first dose of the vaccine my right arm was sore to the touch, a little itching. By 2/28 it is hot to the touch, swollen, red and hurts. I will be going into the doctor to have them take a look at it since it has been 2 weeks since I received the vaccine as of today 3/1.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: headache, chills, fever, muscle aches, slowly reducing over three days
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Mobility decreased, Pain
Clinical narrative: Rather severe back ache (lumbar & thoracic) to the point that I could not bend over, twist to either side or even cough without a severe stabbing pain and then general soreness.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Incorrect route of product administration
Clinical narrative: WHILE ADMINISTRING THE VACCINE THE LIQUID SHOT FROM AROUND THE NEEDLE OF THE SYRINGE AND SOME OF THE LIQUID WENT INTO THE PATIENT AND NURSES EYE. IT APPEARED NONE OF THE VACCINE WAS ENTERED INTO THE MUSCLE. MODERNA CONTACTED AND WAS TOLD TO REFER TO OUR PHYSICAN PROTOCAL .  PER OUR PHYSICAN WE WERE TO RE ADMINISTER THE VACCINE TO THE PATIENT.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Electromyogram, Guillain-Barre syndrome, Lumbar puncture, Magnetic resonance imaging, Magnetic resonance imaging spinal
Clinical narrative: Guillain Barre Syndrome
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Nerve conduction studies
Clinical narrative: Guillain Barre Syndrome
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ear pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: Woke morning after the shot with pain alone right side of the body from head to hip, worst in arm,  low grade fever and earache right side only.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Pain in shot area, Fatigue and exhaustion, headaches, physical bodily pains throughout entire body and today diarrhea and vomiting
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Pain in shot area, Fatigue and exhaustion, headaches, physical bodily pains throughout entire body and today diarrhea and vomiting
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Eye irritation, Fatigue, Injection site pain, Pyrexia
Clinical narrative: Dizziness; uncontrolled head shaking; low grade fever; burning eyes; pain in injection site; fatigue.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: Dizziness; uncontrolled head shaking; low grade fever; burning eyes; pain in injection site; fatigue.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Dry mouth, Dysphagia, Feeling cold
Clinical narrative: Perfectly fine until about 25 minutes after the injection.  Then, nausea and dizziness started, followed by burning and itching on both sides of tongue.  Then the back of the throat started hurting, and it became hard to swallow, followed by becoming very cold, chills, and dry mouth.  Finally the skin area around mouth and lips and up through the cheek/jawline became very itchy.       It was not anaphylaxis because my breathing was okay.  We drove home, and I took two Benedryl (50 mg) upon arriving home.  Within 2 hours all symptoms subsided with the exception of a nasty headache.  Today, I am fine, but just have a sore arm at the site.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Lip pruritus, Nausea, Oral pruritus, Oropharyngeal pain
Clinical narrative: Perfectly fine until about 25 minutes after the injection.  Then, nausea and dizziness started, followed by burning and itching on both sides of tongue.  Then the back of the throat started hurting, and it became hard to swallow, followed by becoming very cold, chills, and dry mouth.  Finally the skin area around mouth and lips and up through the cheek/jawline became very itchy.       It was not anaphylaxis because my breathing was okay.  We drove home, and I took two Benedryl (50 mg) upon arriving home.  Within 2 hours all symptoms subsided with the exception of a nasty headache.  Today, I am fine, but just have a sore arm at the site.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tongue discomfort, Tongue pruritus
Clinical narrative: Perfectly fine until about 25 minutes after the injection.  Then, nausea and dizziness started, followed by burning and itching on both sides of tongue.  Then the back of the throat started hurting, and it became hard to swallow, followed by becoming very cold, chills, and dry mouth.  Finally the skin area around mouth and lips and up through the cheek/jawline became very itchy.       It was not anaphylaxis because my breathing was okay.  We drove home, and I took two Benedryl (50 mg) upon arriving home.  Within 2 hours all symptoms subsided with the exception of a nasty headache.  Today, I am fine, but just have a sore arm at the site.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms
Clinical narrative: Muscle spasms
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Lymph node pain, Lymphadenopathy, Tremor
Clinical narrative: Cold chills, shakes, sore and swollen lymph nodes
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhage, Injection site erythema, Injection site induration, Injection site swelling, Pruritus
Clinical narrative: Unusual amount of blood dropped down my arm immediately after the injection (seemed strange for an injection in the upper arm). Redness and swelling at injection site that  progressed over night and the next days becoming a hard red lump. Very itchy on the same day of the injection and following days.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Increased viscosity of upper respiratory secretion, Oropharyngeal discomfort
Clinical narrative: Patient notified nurse within in 1 minute of vaccine administration of feeling of thickness in throat area. Patient monitored for 30 minutes in Covid Vaccine Clinic. Thickness in throat area started at 0850 and at 0910, patient stated of no longer having symptoms. Patient discharged from clinic.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Nausea, Vomiting
Clinical narrative: nausea, headache, threw up entire meals for 2 days by the third day I was feeling better.  Tiredness still lingers.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac monitoring, Diplopia, Palpitations
Clinical narrative: Vaccine may have caused flare in Graves Disease symptoms.  4 days after the vaccination, I started having heart palpitations.  6 days after the vaccination, I started having double vision in the morning.  I have never had heart palpitations from Graves before, although it is a common problem with it I have not had double vision since my eye surgery 5 years ago.  Am wondering whether to proceed with second dose of the Moderna vaccine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Back pain, Depression, Feeling abnormal, Headache
Clinical narrative: Moderate to severe pain in arm, shoulder, back started about one hour after shot. Lasted until next morning. No medication taken. Moderate headache lasting through next morning, general grumpiness for 2 days, brain fog beginning following morning - forgetfulness, depression. Still continued through today (Monday, March 1, 2021). Symptoms are not severe, but are acute enough that they are impacting quality of life.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Impaired quality of life, Memory impairment, Mood altered, Pain in extremity
Clinical narrative: Moderate to severe pain in arm, shoulder, back started about one hour after shot. Lasted until next morning. No medication taken. Moderate headache lasting through next morning, general grumpiness for 2 days, brain fog beginning following morning - forgetfulness, depression. Still continued through today (Monday, March 1, 2021). Symptoms are not severe, but are acute enough that they are impacting quality of life.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Hypoaesthesia oral, Paraesthesia, Paraesthesia oral
Clinical narrative: Tingling in hands bilaterally began at 15min mark post vaccination. Approx 15min later tingling traveled down to legs bilat. Approx 15min after that, tingling traveled into face around cheeks and lips bilaterally. Patient noted numbness around face and lips. Pulse 70, Resp 14, no BP taken due to equipment failure.  Recommended patient seek further medical observation by ER or Urgent Care, patient verbalized understanding.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site pruritus, Injection site rash, Injection site reaction
Clinical narrative: Some soreness at site of injection immediately but of no concern. About 1 week later itching at the site and red rash around injection site and upper arm descending to and around arm
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash erythematous
Clinical narrative: Some soreness at site of injection immediately but of no concern. About 1 week later itching at the site and red rash around injection site and upper arm descending to and around arm
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chills, Mobility decreased, Pain, Pyrexia
Clinical narrative: Unable to get out of bed, fever, chills, INTENSE body aches and weakness
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Burning sensation, Chills, Eye pain
Clinical narrative: 11 hours after the shot I got intense chills. My entire body was in pain, I had a headache, my eyes hurt and were on fire. After Tylenol, I was soaking wet but the body aches, joint pain, exhaustion continued. My left arm (injection site)was hard to lift and the injection point very sore. The following day 2/28- I was depleted of energy, my body was achy. I still had chills but to a much lesser degree. Throughout the night of 2/28-3/1 I had on and off chill/ sweats. This morning, 3/1, My chills and headache are gone. I still have injection site pain with a red circle and the arm is hard to lift. The body aches have lessened. I am still very lethargic.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hyperhidrosis, Injection site pain, Lethargy, Mobility decreased
Clinical narrative: 11 hours after the shot I got intense chills. My entire body was in pain, I had a headache, my eyes hurt and were on fire. After Tylenol, I was soaking wet but the body aches, joint pain, exhaustion continued. My left arm (injection site)was hard to lift and the injection point very sore. The following day 2/28- I was depleted of energy, my body was achy. I still had chills but to a much lesser degree. Throughout the night of 2/28-3/1 I had on and off chill/ sweats. This morning, 3/1, My chills and headache are gone. I still have injection site pain with a red circle and the arm is hard to lift. The body aches have lessened. I am still very lethargic.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: 11 hours after the shot I got intense chills. My entire body was in pain, I had a headache, my eyes hurt and were on fire. After Tylenol, I was soaking wet but the body aches, joint pain, exhaustion continued. My left arm (injection site)was hard to lift and the injection point very sore. The following day 2/28- I was depleted of energy, my body was achy. I still had chills but to a much lesser degree. Throughout the night of 2/28-3/1 I had on and off chill/ sweats. This morning, 3/1, My chills and headache are gone. I still have injection site pain with a red circle and the arm is hard to lift. The body aches have lessened. I am still very lethargic.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Rash
Clinical narrative: Swollen arm and rash that has lasted 12 days
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Nausea, Pain
Clinical narrative: Chills, body aches beginning at around 3:30 AM Sunday 2/28. Felt like low fever but I don?t have a thermometer. Fatigue all day Sunday with aches and chills, no appetite. I took Tylenol every 6 hours.  Then around 1:00 AM Monday 3/1 I began vomiting every half hour or so until 3:30 AM. Feeling fatigue and nausea still at this time.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: Chills, body aches beginning at around 3:30 AM Sunday 2/28. Felt like low fever but I don?t have a thermometer. Fatigue all day Sunday with aches and chills, no appetite. I took Tylenol every 6 hours.  Then around 1:00 AM Monday 3/1 I began vomiting every half hour or so until 3:30 AM. Feeling fatigue and nausea still at this time.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Depression, Disturbance in attention, Headache, Mood altered
Clinical narrative: Daily headaches continue since second vaccine.  Significant change in mood and concentration/depression from aproximately 1-2 wks post vaccine,
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Throat tightness
Clinical narrative: Throat tightness, chest tightness-cleared by EMS
Age: 67.0
Sex: U
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus, Rash erythematous
Clinical narrative: COVID arm.....big red circle and rash, swelling, itching
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chills, Discomfort, Heart rate increased, Inflammation
Clinical narrative: At roughly 2:30pm, started with nausea and chills,  went home went to bed.   Severe muscles cramping and soreness.  Went to ER for this was perscribed naproxen for inflammation.   Still nothing helped.  Went back to ER with elevated heart rate and BP due to the discomfort was accused of being a pill seeker.   I just want the pain and muscle cramps to stop.  I hurt from head to toe.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Muscle spasms, Myalgia, Nausea, Pain
Clinical narrative: At roughly 2:30pm, started with nausea and chills,  went home went to bed.   Severe muscles cramping and soreness.  Went to ER for this was perscribed naproxen for inflammation.   Still nothing helped.  Went back to ER with elevated heart rate and BP due to the discomfort was accused of being a pill seeker.   I just want the pain and muscle cramps to stop.  I hurt from head to toe.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Myalgia, Pain, Pain in extremity
Clinical narrative: Initially I had large red areas around my upper arm which was not painful. This redness lasted several days and finally went away. My arm has remained very sore. After the first injection it was sore for a few days and went away. This soreness has not gone away.  It feels like a very sore muscle and is painful with certain range of motion. It has of today been over 6 weeks since the 2nd injection.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Palpitations
Clinical narrative: Palpitations, weakness-cleared by EMS
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Feeling cold, Headache, Injection site erythema, Injection site pain
Clinical narrative: Fever, Nausea, Muscle and Join pain, headache, fatigue, chills, large red welt around injection site hot and painful to touch. It also itches. Took Tylenol and slept the symptoms out. Back to mostly normal Sunday 2/28, but on Monday 3/1 still feeling  headache, some aches,  chills, and nausea, but can tell it is starting to taper off.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site warmth, Myalgia, Nausea, Pyrexia, Urticaria
Clinical narrative: Fever, Nausea, Muscle and Join pain, headache, fatigue, chills, large red welt around injection site hot and painful to touch. It also itches. Took Tylenol and slept the symptoms out. Back to mostly normal Sunday 2/28, but on Monday 3/1 still feeling  headache, some aches,  chills, and nausea, but can tell it is starting to taper off.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Dizziness, Fatigue, Headache, Rash
Clinical narrative: Mild rash over entire  body.  Headache.  Cough that developed and worsened over several days similar to an asthmatic  cough following bronchitis.  Severe fatigue.  Sluggish focus Slight dizziness.  Slight difficult if reading after a brief time of reading.  Slight nausea.  Swelling over entire body.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Sluggishness, Swelling
Clinical narrative: Mild rash over entire  body.  Headache.  Cough that developed and worsened over several days similar to an asthmatic  cough following bronchitis.  Severe fatigue.  Sluggish focus Slight dizziness.  Slight difficult if reading after a brief time of reading.  Slight nausea.  Swelling over entire body.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, body  ache, low grade fever
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Developed chills; Fever; This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (1st dose received on an unknown date,refer case US2021AMR001133). Concomitant products included valaciclovir hydrochloride (Valtrex).   On 2nd January 2021, the patient received the 2nd dose of Shingrix. On 3rd January 2021, 1 days after receiving Shingrix, the patient experienced chills and fever. The patient was treated with paracetamol (Tylenol). On 3rd January 2021, the outcome of the chills was recovered/resolved. On 4th January 2021, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the chills and fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The age at vaccination was not reported. The patient developed chills and a fever.  On 03 January 2021, the patient was treated with tylenol  for chills and fever. The reporter stated that on 4th January 2021 she had a slight fever that has resolved. The reporter refused to provide any additional information and hunged up abruptly. The reporter did not consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR001133:Same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Pyrexia
Clinical narrative: palpitations; fever of 102.; This case was reported by a consumer via call center representative and described the occurrence of palpitation in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced palpitation and fever. On an unknown date, the outcome of the palpitation and fever were unknown.   It was unknown if the reporter considered the palpitation and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received dose of Shingrix and experienced palpitations and fever of 102 degree fahrenhiet. The reporter did not consent to follow up. Limited demographics and details due to caller's refusal to provide information for safety report.