chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypoaesthesia, Skin discolouration
Clinical narrative: Dizzy, light headed,and left arm numb.  Laid down, felt better after laying down Monitored heart rate 68 , no shortness of breath and color was pink.  once symptoms were gone, was released and informed if any further symptoms to go to ER.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Myalgia, Pharyngeal swelling
Clinical narrative: while in the observation period stated that her tongue felt thick and that it felt like her throat was swollen. Received .5ml epinepherine im and oxygen by nasal cannula. EMS summoned. Refused transport to hospital and declination signed with the EMS agency.Left the clinic in no acute distress.
Age: 36.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pharyngeal swelling, Tongue disorder
Clinical narrative: while in the observation period stated that her tongue felt thick and that it felt like her throat was swollen. Received .5ml epinepherine im and oxygen by nasal cannula. EMS summoned. Refused transport to hospital and declination signed with the EMS agency.Left the clinic in no acute distress.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anxiety, Burning sensation, Flushing
Clinical narrative: received vaccine and within 10 minutes felt flushed all over body and felt she was going to pass out. Was given Benadryl. had a similar episode 10 minutes after and continued to feel off until 4 hours had passed. Has not had any more symptoms after.
Age: 37.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Flushing
Clinical narrative: received vaccine and within 10 minutes felt flushed all over body and felt she was going to pass out. Was given Benadryl. had a similar episode 10 minutes after and continued to feel off until 4 hours had passed. Has not had any more symptoms after.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Hypoacusis, Hypoaesthesia oral, Palpitations
Clinical narrative: blurred vision, dampened hearing, sweating, clenched hands, tongue swelling, tightened muscles in arms and legs, difficulty breathing. EpiPen was given into left leg. Tongue swelling went down and breathing went back to normal after a few minutes. Clenched muscles went away after approximately 15 minutes after EpiPen was administered.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Panic attack, Paraesthesia, Swollen tongue, Tremor, Tunnel vision
Clinical narrative: blurred vision, dampened hearing, sweating, clenched hands, tongue swelling, tightened muscles in arms and legs, difficulty breathing. EpiPen was given into left leg. Tongue swelling went down and breathing went back to normal after a few minutes. Clenched muscles went away after approximately 15 minutes after EpiPen was administered.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Hyperhidrosis, Impaired healing, Muscle spasms, Muscle tightness
Clinical narrative: blurred vision, dampened hearing, sweating, clenched hands, tongue swelling, tightened muscles in arms and legs, difficulty breathing. EpiPen was given into left leg. Tongue swelling went down and breathing went back to normal after a few minutes. Clenched muscles went away after approximately 15 minutes after EpiPen was administered.
Age: 28.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swollen tongue, Vision blurred
Clinical narrative: blurred vision, dampened hearing, sweating, clenched hands, tongue swelling, tightened muscles in arms and legs, difficulty breathing. EpiPen was given into left leg. Tongue swelling went down and breathing went back to normal after a few minutes. Clenched muscles went away after approximately 15 minutes after EpiPen was administered.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Erythema, Hypoaesthesia, Paraesthesia
Clinical narrative: Instant headache, blurred vision/dizzy, waves of tingling, felt like couldn?t breath. Red chest per nurse report. Given Epinephrine, monitored at hospital for 4 hours following Epinephrine.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Erythema, Headache, Paraesthesia
Clinical narrative: Instant headache, blurred vision/dizzy, waves of tingling, felt like couldn?t breath. Red chest per nurse report. Given Epinephrine, monitored at hospital for 4 hours following Epinephrine.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Vision blurred
Clinical narrative: Instant headache, blurred vision/dizzy, waves of tingling, felt like couldn?t breath. Red chest per nurse report. Given Epinephrine, monitored at hospital for 4 hours following Epinephrine.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain in jaw, Toothache
Clinical narrative: Headache, fever, body pain
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Headache, fever, body pain
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction
Clinical narrative: Within 10 min of receiving dose #2 of Pfizer covid vaccine, Patient (MD) developed diffuse itching followed by SOB, chest tightness, bronchospasms, 'barky' cough, warmth and itching ears, throat lips.  She was taken to ED for stabilization.  She was later admitted to the ICU where she was cared for for about 24 hours.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bronchospasm, Chest discomfort, Cough, Dyspnoea, Ear pruritus
Clinical narrative: Within 10 min of receiving dose #2 of Pfizer covid vaccine, Patient (MD) developed diffuse itching followed by SOB, chest tightness, bronchospasms, 'barky' cough, warmth and itching ears, throat lips.  She was taken to ED for stabilization.  She was later admitted to the ICU where she was cared for for about 24 hours.
Age: 56.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Intensive care, Lip pruritus, Pruritus, Skin warm, Throat irritation
Clinical narrative: Within 10 min of receiving dose #2 of Pfizer covid vaccine, Patient (MD) developed diffuse itching followed by SOB, chest tightness, bronchospasms, 'barky' cough, warmth and itching ears, throat lips.  She was taken to ED for stabilization.  She was later admitted to the ICU where she was cared for for about 24 hours.
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Fatigue, Full blood count, Headache, Metabolic function test
Clinical narrative: Patient is a 26-year-old female who presents today with symptoms including migraine, "brain fog", fatigue, low grade fevers, and dizziness that began 6 days ago following receiving her first dose of COVID-19 vaccine. Pt. States she was tested for COVID 3 days prior to vaccine and this was negative. Pt. Says she had been sick for 6-7 days prior to taking vaccine and believes her immune system might of been weak from this.  She received Moderna COVID vaccine at hospital. Her symptoms were more persistent and with more intensity for the first 3-4 days but now the symptoms are more "off and on."  Her headache is posterior and the dizziness is also "more intermittent than before." Her headache is rated 4/10 at this time. She has taken OTC NSAIDS without much relief. The "dizziness" seems to occur randomly and is not aggravated by rapid positional changes. She does ingest moderate amounts of caffeine to boost her energy level while at work. She denies visual changes/focal weakness/discoordination/nausea/vomiting/abd pain/shortness of breath/wheezing. Pt. Reports that she has been very concerned about making sure she takes the right measures to help prevent getting COVID infection. She has researched the COVID vaccines, how they are made, and which are "more potent."
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pyrexia
Clinical narrative: Patient is a 26-year-old female who presents today with symptoms including migraine, "brain fog", fatigue, low grade fevers, and dizziness that began 6 days ago following receiving her first dose of COVID-19 vaccine. Pt. States she was tested for COVID 3 days prior to vaccine and this was negative. Pt. Says she had been sick for 6-7 days prior to taking vaccine and believes her immune system might of been weak from this.  She received Moderna COVID vaccine at hospital. Her symptoms were more persistent and with more intensity for the first 3-4 days but now the symptoms are more "off and on."  Her headache is posterior and the dizziness is also "more intermittent than before." Her headache is rated 4/10 at this time. She has taken OTC NSAIDS without much relief. The "dizziness" seems to occur randomly and is not aggravated by rapid positional changes. She does ingest moderate amounts of caffeine to boost her energy level while at work. She denies visual changes/focal weakness/discoordination/nausea/vomiting/abd pain/shortness of breath/wheezing. Pt. Reports that she has been very concerned about making sure she takes the right measures to help prevent getting COVID infection. She has researched the COVID vaccines, how they are made, and which are "more potent."
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Eosinophil percentage decreased, Fatigue, Feeling abnormal, Glomerular filtration rate normal
Clinical narrative: Patient is a 26-year-old female who presents today with symptoms including migraine, "brain fog", fatigue, low grade fevers, and dizziness that began 6 days ago following receiving her first dose of COVID-19 vaccine. Pt. States she was tested for COVID 3 days prior to vaccine and this was negative. Pt. Says she had been sick for 6-7 days prior to taking vaccine and believes her immune system might of been weak from this.  She received Moderna COVID vaccine at hospital. Her symptoms were more persistent and with more intensity for the first 3-4 days but now the symptoms are more "off and on."  Her headache is posterior and the dizziness is also "more intermittent than before." Her headache is rated 4/10 at this time. She has taken OTC NSAIDS without much relief. The "dizziness" seems to occur randomly and is not aggravated by rapid positional changes. She does ingest moderate amounts of caffeine to boost her energy level while at work. She denies visual changes/focal weakness/discoordination/nausea/vomiting/abd pain/shortness of breath/wheezing. Pt. Reports that she has been very concerned about making sure she takes the right measures to help prevent getting COVID infection. She has researched the COVID vaccines, how they are made, and which are "more potent."
Age: 26.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Haematocrit normal, Headache, Migraine, Pyrexia, White blood cell count
Clinical narrative: Patient is a 26-year-old female who presents today with symptoms including migraine, "brain fog", fatigue, low grade fevers, and dizziness that began 6 days ago following receiving her first dose of COVID-19 vaccine. Pt. States she was tested for COVID 3 days prior to vaccine and this was negative. Pt. Says she had been sick for 6-7 days prior to taking vaccine and believes her immune system might of been weak from this.  She received Moderna COVID vaccine at hospital. Her symptoms were more persistent and with more intensity for the first 3-4 days but now the symptoms are more "off and on."  Her headache is posterior and the dizziness is also "more intermittent than before." Her headache is rated 4/10 at this time. She has taken OTC NSAIDS without much relief. The "dizziness" seems to occur randomly and is not aggravated by rapid positional changes. She does ingest moderate amounts of caffeine to boost her energy level while at work. She denies visual changes/focal weakness/discoordination/nausea/vomiting/abd pain/shortness of breath/wheezing. Pt. Reports that she has been very concerned about making sure she takes the right measures to help prevent getting COVID infection. She has researched the COVID vaccines, how they are made, and which are "more potent."
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Bone disorder, Bone pain, Chills, Fatigue
Clinical narrative: pain in the left armpit; a small protrusion in the area of the left collarbone which hurts to the touch; a small protrusion in the area of the left collarbone which hurts to the touch; feeling headache; tiredness; chills; bnt162b2 first dose on 15Dec2020 at 14:30 and then second dose on 04Jan2021 at 15:30; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK4176), intramuscularly on 04Jan2021 at 15:30 on Arm Left at single dose for COVID-19 immunization in hospital. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. No concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, nor any other medications within two weeks of vaccination. The patient previous took acetylsalicylic acid (ASPIRIN) and experienced allergy; first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 15Dec2020 at 14:30 on Arm Left at single dose for COVID-19 immunization and had pain in her left arm where it was administered the vaccine on 15Dec2020 at 15:00, the next day (16Dec2020) the area was red and inflamed, the redness and the inflammation lasted three days. The patient experienced hours after receiving the second dose of the vaccine she began feeling headache, tiredness and chills on 04Jan2021 at 21:00. The next day of the vaccine on 05Jan2021 she began feeling pain in the left armpit and she had a small protrusion in the area of the left collarbone which hurts to the touch. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Inappropriate schedule of product administration
Clinical narrative: pain in the left armpit; a small protrusion in the area of the left collarbone which hurts to the touch; a small protrusion in the area of the left collarbone which hurts to the touch; feeling headache; tiredness; chills; bnt162b2 first dose on 15Dec2020 at 14:30 and then second dose on 04Jan2021 at 15:30; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received second dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, batch/lot number: EK4176), intramuscularly on 04Jan2021 at 15:30 on Arm Left at single dose for COVID-19 immunization in hospital. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. No concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, nor any other medications within two weeks of vaccination. The patient previous took acetylsalicylic acid (ASPIRIN) and experienced allergy; first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: EH9899) on 15Dec2020 at 14:30 on Arm Left at single dose for COVID-19 immunization and had pain in her left arm where it was administered the vaccine on 15Dec2020 at 15:00, the next day (16Dec2020) the area was red and inflamed, the redness and the inflammation lasted three days. The patient experienced hours after receiving the second dose of the vaccine she began feeling headache, tiredness and chills on 04Jan2021 at 21:00. The next day of the vaccine on 05Jan2021 she began feeling pain in the left armpit and she had a small protrusion in the area of the left collarbone which hurts to the touch. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events was not recovered. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site inflammation, Vaccination site pain
Clinical narrative: have pain in my left arm where it was administered the vaccine/the area was red and inflamed; have pain in my left arm where it was administered the vaccine/the area was red and inflamed; pain in my left arm where it was administered the vaccine; This is a spontaneous report from a contactable nurse (patient). A 29-year-old female patient (not pregnant) received first dose of bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE, Batch/lot number: EH9899), via an unspecified route of administration on 15Dec2020 at 14:30 on Arm Left at single dose for COVID-19 immunization in hospital. The patient medical history was not reported. Prior to vaccination, patient was not diagnosed with COVID-19. No concomitant medications. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine, nor any other medications within two weeks of vaccination. The patient previous took acetylsalicylic acid (ASPIRIN) and experienced allergy. The patient experienced started to have pain in her left arm where it was administered the vaccine on 15Dec2020 at 15:00. The next day (16Dec2020) the area was red and inflamed. The redness and the inflammation lasted three days. Since the vaccination, patient had not been tested for COVID-19. No treatment was received for the events. The outcome of the events 'redness and the inflammation' was recovered on 19Dec2020, outcome of the other event was unknown. The report was reported as non-serious, with seriousness criteria-Results in death: No; Life threatening: No; Caused/prolonged hospitalization: No; Disabling/Incapacitating: No; Congenital anomaly/birth defect: No.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: No additional AE information provided; Caller reported temperature excursion/Temperature -13.3C; This spontaneous report was received from a registered nurse concerning to a 5-year-old patient of unknown gender. The patient's medical history, historical drugs, allergies, concurrent conditions and concomitant therapies were not provided.   On 23-NOV-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 0.5 milliliter (ml) for prophylaxis, lot number reported as T021642 and expiration date as 21-DEC-2021 (vaccination scheme, route of administration and anatomical site of vaccination were not provided).   The administered vaccine had a temperature excursion of -13.3 degrees Celsius (°C) for a time frame of 4 hours and 15 minutes (product storage error) on an unspecified date, and the data was recorded by a digital data logger. It was also reported there was not a previous temperature excursion. No additional adverse events were reported.    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2012USA013501: US-009507513-2012USA013584: US-009507513-2012USA013596:
Age: 70.0
Sex: U
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: Bell's palsy; Information has been received from a lawyer and an elderly patient of unknown age and gender, regarding a case in litigation. Information about concurrent condition, medical history and concomitant medication was not reported. In or about 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, lot#, expiration date and route unknown) for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a healthcare provider for the following injuries resulting from zoster vaccine live (ZOSTAVAX): Bell's palsy. The outcome of the event was unknown.   Upon internal review, Bell's palsy was determined to be medically significant.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Injury
Clinical narrative: SHINGLES; Information has been received regarding a case in litigation from a lawyer referring to a currently 65 years old patient of unknown gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In or about 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) in a hospital for the long-term prevention of shingles and zoster-related conditions. Subsequently, the patient was treated by a provider for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles. The outcome of the event shingles was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no other AE ocurred; VARIVAX was administered to a patient after improper storage/temperature excursion; This spontaneous report was received from a customer who was a medical assistant and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, or allergies were not reported.  On 06-JAN-2021, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection dose 1, (strength, dose, vaccination scheme, anatomical site of injection and route of administration were not reported; lot number T017686, expiration date: 21-MAY-2022) as prophylaxis. The vaccine administered experienced a temperature excursion of minus 12.5 degrees Celsius (C) for 11 hours and 10 minutes (product storage error), as recorded by a data logger. No other adverse effect (AE) occurred. Previous temperature excursion of minus 14 degree Celsius to minus 10 degree Celsius (minus 12 degree Celsius) for 2 hours and 30 minutes was reported.   .
Sex: M
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: The patient did not experience any adverse event during or aftere the injection; Patient who received a dose of MMRII on 06-JAN-2021 and it was realized later that the dose he received had expired 24-OCT-2020; This spontaneous report was received from a pharmacist concerning a 21 year old male patient. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided.      On 06-JAN-2021, the patient was vaccinated with an expired vaccine of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (expired product administered) for prophylaxis ( lot # R030812 had been determined to be a valid lot number measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live, expiration date reported and establish as 24-OCT-2020) (strength, dose, route of administration and anatomical location were not provided).  No adverse event reported.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Inappropriate schedule of product administration, Injection site pain
Clinical narrative: yesterday I had my follow-up 2nd shot; minor soreness at the injection site; I´ve been feeling tired all day / tiredness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in December 2019).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional information was provided as follows: The age at vaccination was not applicable. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination. The patient had been unable to receive second dose Shingrix. The reporter consented to follow up. Consumer declined to provide mailing address and consumer declined to provide further information for safety report.   Follow up information received from consumer on 9th December 2020: On 8th December 2020, the patient received the 2nd dose of Shingrix later than the recommended interval, which led to lengthening of vaccination schedule. In December 2020, the patient experienced minor injection site soreness and feeling of tiredness all day which was unusual for the patient.  The reporter wanted to know was tiredness a possible side effect and how long should it lasts. It was unknown if the reporter considered the injection site pain and tiredness to be related to Shingrix.
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site papule
Clinical narrative: Redness at site of injection; Papule / persistent light pink 5x7cm rectangular papule; This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 4-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd October 2020, the patient received the 1st dose of Fluarix Tetra 2020-2021 season (intramuscular). On an unknown date, the patient started Fluarix Tetra Pre-Filled Syringe Device. On 29th October 2020, 6 days after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced injection site erythema and papule. On an unknown date, the outcome of the injection site erythema and papule were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema and papule to be related to Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Fluarix QIV and several days later, could not be specified by reporter, the patient presented a papule (5 by 7 cm) and some redness at site of injection it was not itchy.  The papule was persistent and had not cleared up. The reporter consented to follow up. This case US2020230710 is duplicate of case US2020230712 and all information submitted in case US2020230710.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020230712:FU1 deleted
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Migraine
Clinical narrative: worsening migraines since receiving her first Shingrix vaccine; This case was reported by a pharmacist via call center representative and described the occurrence of migraine aggravated in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included migraine.   On 11th November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced migraine aggravated. On an unknown date, the outcome of the migraine aggravated was not recovered/not resolved.   It was unknown if the reporter considered the migraine aggravated to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced worsening migraines since receiving her 1st Shingrix vaccine. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein increased
Clinical narrative: Results showing elevated / C-reactive protein; Results showing elevated sedimentation rate; This case was reported by a consumer via call center representative and described the occurrence of c-reactive protein increased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19th December 2020, the patient received the 1st dose of Shingrix. On 21st December 2020, 2 days after receiving Shingrix, the patient experienced c-reactive protein increased and elevated sedimentation rate. On an unknown date, the outcome of the c-reactive protein increased and elevated sedimentation rate were unknown.   It was unknown if the reporter considered the c-reactive protein increased and elevated sedimentation rate to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced increased level of C-reactive protein and sedimentation rate. The reporter mentioned that, patient did previous test and results were normal. No additional information provided. The reporter did not consent to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Feeling hot
Clinical narrative: redness of the shoulder / redness is about 5 inches by 3 inches; shoulder that is hot to the touch; This case was reported by a consumer via call center representative and described the occurrence of localized erythema in a 73-year-old male patient who received Herpes zoster (Shingrix) (batch number 4BA4A, expiry date 29th January 2022) for prophylaxis.   On 21st December 2020 09:00, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In December 2020, less than a week after receiving Shingrix, the patient experienced localized erythema and feeling hot. On an unknown date, the outcome of the localized erythema and feeling hot were not recovered/not resolved.   It was unknown if the reporter considered the localized erythema and feeling hot to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right deltoid and experienced redness of shoulder 5 inches by 3 inches and shoulder was hot to touch. The reporter mentioned that, events were still not resolved at the time of reporting. The reporter stated that the primary care physician had been seeing had retired, and that he currently has not had a primary care physician. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Did not get full dose; A spontaneous report was received from a pharmacist concerning a 61-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, did not get full dose.    The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 27 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 011J20A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 27 Dec 2020, during vaccine administration, a portion of the vaccine dripped on the patient's arm due to an issue with the needle and the syringe, and the patient did not get full dose of vaccine. Treatment for the event was not provided.  Action taken with mRNA-1273 in response to the event was not provided.   The event, did not get full dose, was considered resolved on 27 Dec 2020.; Reporter's Comments: This report refers to a case of Incorrect dose administered for mRNA-1273, lot # 011J20A. There were no reported AEs associated with this case of Incorrect dose administered.
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 0.3mL; A spontaneous report was received from pharmacist concerning a 49-year-old female patient who received Moderna's COVID-19 vaccine and the patient received 0.3mL.   The patient's medical history was not provided. No relevant concomitant medications were reported.   On 28 Dec 2020, the patient received her first of two planned doses of mRNA-1273 (Lot number: 039K20-2A) intramuscularly in the left deltoid for prophylaxis of COVID-19 infection.   On 28 Dec 2020, the patient was given 0.3 ml dose of the vaccine instead of 0.5 ml. No treatment information was provided. The patient had no adverse reactions.  Action taken with mRNA-1273 in response to the event was not reported.   The event, patient received 0.3mL, was considered resolved on 28 Dec 2020.; Reporter's Comments: This case concerns a 49 year-old, female patient, who experienced an event of incorrect dose administered after receiving her first dose of COVID-19 vaccine. No adverse events were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: employees vaccinated from a vial that was punctured more than 6 hours ago; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, expired product administered.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 011J20A) intramuscularly for prophylaxis of COVID-19 infection.  The reporter stated that the Moderna COVID-19 vaccine was given out this week with doses from a vial that had been punctured for more than 6 hours instead of being discarded. She stated that the punctured vials were placed in the fridge or on top of an ice pack or in the carton and used beyond 6 hours after it was first punctured. No other specific details were provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The event, expired product administered, was considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns a patient who received their first of two planned doses of mRNA-1273 (Lot-# 011J20A; expiration date- unknown), reporting an expired product administered. The event occurred the same day of vaccine administration. The reporter did not provide the causality assessment. The event of expired product administered was assessed as not related to Moderna COVID-19 Vaccine.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: employees were vaccinated from a vial that was punctured more than 6 hours ago; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine and who experienced an expired product administered.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 22 Dec 2020, a vial containing the Moderna COVID-19 vaccine was punctured.  Instead of being discarded, the vial was placed in cold storage.  On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (LOT number 011J20A) for prophylaxis of COVID-19 infection.   On 27 Dec 2020, the nurse reported that the patient had received the mRNA-1273 vaccine from the vial that was punctured more than 6 hours before administration.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The event, expired product administered, was considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns an unidentified patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Expired product administered without any associated adverse events.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Employees were vaccinated from a vial that was punctured more than 6 hours ago; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 Vaccine and who experienced an expired product administered.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 22 Dec 2020, a vial containing the Moderna COVID-19 vaccine was punctured.  Instead of being discarded, the vial was placed in cold storage.  On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (LOT number 011J20A) for prophylaxis of COVID-19 infection.   On 27 Dec 2020, the nurse reported that the patient had received the mRNA-1273 vaccine from the vial that was punctured more than 6 hours before administration.  Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.  The event, expired product administered, was considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns a patient, who experienced an event of expired product administered after receiving the first dose of mRNA-1273 vaccine. No adverse events were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Employees vaccinated from a vial that was punctured more than 6 hours ago; A spontaneous report was received from a nurse concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event, expired product administered.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.   On 23 Dec 2020, the patient received their first of two planned doses of mRNA-1273 (Lot # 011J20A) for prophylaxis of COVID-19 infection.  On 27 Dec 2020, the nurse reported that the Moderna COVID-19 vaccine was given out on 23 Dec 2020 and 24 Dec 2020 with doses from a vial that had been punctured for more than 6 hours instead of being discarded. She stated that the punctured vials were placed in the fridge or on top of an ice pack or in the carton and used beyond 6 hours after it was first punctured. No other specific details were provided. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not provided.   The event, expired product administered, was considered resolved on 23 Dec 2020.; Reporter's Comments: This case concerns an unidentified patient who received their first of two planned doses of mRNA-1273 (Lot 011J20A), reporting Expired product administered without any associated adverse events.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Loss of consciousness
Clinical narrative: Passed out twice; Pain in the injection site; Slight headache; A spontaneous report was received from a consumer concerning a 24-year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the events, passed out twice, pain in the injection site, and slight headache.   The patient's medical history was not reported. No concomitant medications were reported.   On 26 Dec 2020 at 1:58 pm, approximately three hours prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 026L2DA) intramuscularly for prophylaxis of COVID-19 infection.   On 26 Dec 2020, at 5:00 pm, the patient passed out. She also had pain in the injection site and a slight headache.   On 27 Dec 2020, at 8:30 am, the patient passed out again. No treatment information was provided.  The Action taken with mRNA-1273 in response to the events was not reported.  The outcome for the events, passed out twice, pain in the injection site, and slight headache was unknown.; Reporter's Comments: This case concerns a 24 year old female patient, who experienced a serious unexpected event of loss of consciousness and non-serious expected event of injection site pain and headache. The event occurred apparently few hours after first dose of mRNA-1273 (Lot # 026L2DA) administration. 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.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Chest discomfort, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Shortness of breath; Tingling; Numbness of body, face, neck; Tachycardia at 144; Palpitation; Elevated BP at 140/90; Chest tightness; Dizziness; Flushing of face; A spontaneous report was received from a physician, who was a 34-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness of body, face, and neck, tingling, tachycardia at 144, palpitation, elevated blood pressure (BP) at 140/90, chest tightness, shortness of breath, dizziness, and flushing of face.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.     On 27 Dec 2020, three to four minutes after receiving the mRNA-1273 vaccine, the patient experienced numbness of body, face, and neck, tingling, tachycardia at 144, palpitation, elevated BP at 140/90, chest tightness, shortness of breath, dizziness, and flushing of face. The patient reported the elevated BP was not her usual blood pressure. She underwent an electrocardiogram (EKG)unknown results and was given oxygen for the events. No other treatments were administered.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events, numbness of body, face, and neck, tingling, tachycardia at 144, palpitation, elevated BP at 140/90, chest tightness, shortness of breath, dizziness, and flushing of face, was considered resolving.; Reporter's Comments: This case concerns a 34 year old female patient, who experienced a serious unexpected event of hypoesthesia and paraesthesia and non serious unexpected events of dyspnea, tachycardia, palpitations, blood pressure increased, chest discomfort, dizziness and flushing. The event occurred within 3-4 min after first dose of mRNA-1273 (Lot# 025J20-2A) vaccine administration. The patient was treated with oxygen and no medication was administered. 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.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Flushing, Hypoaesthesia, Palpitations, Paraesthesia, Tachycardia
Clinical narrative: Shortness of breath; Tingling; Numbness of body, face, neck; Tachycardia at 144; Palpitation; Elevated BP at 140/90; Chest tightness; Dizziness; Flushing of face; A spontaneous report was received from a physician, who was a 34-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced numbness of body, face, and neck, tingling, tachycardia at 144, palpitation, elevated blood pressure (BP) at 140/90, chest tightness, shortness of breath, dizziness, and flushing of face.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 27 Dec 2020, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number: 025J20-2A) intramuscularly for prophylaxis of COVID-19 infection.     On 27 Dec 2020, three to four minutes after receiving the mRNA-1273 vaccine, the patient experienced numbness of body, face, and neck, tingling, tachycardia at 144, palpitation, elevated BP at 140/90, chest tightness, shortness of breath, dizziness, and flushing of face. The patient reported the elevated BP was not her usual blood pressure. She underwent an electrocardiogram (EKG)unknown results and was given oxygen for the events. No other treatments were administered.  Action taken with mRNA-1273 in response to the events was not reported.    The outcome of the events, numbness of body, face, and neck, tingling, tachycardia at 144, palpitation, elevated BP at 140/90, chest tightness, shortness of breath, dizziness, and flushing of face, was considered resolving.; Reporter's Comments: This case concerns a 34 year old female patient, who experienced a serious unexpected event of hypoesthesia and paraesthesia and non serious unexpected events of dyspnea, tachycardia, palpitations, blood pressure increased, chest discomfort, dizziness and flushing. The event occurred within 3-4 min after first dose of mRNA-1273 (Lot# 025J20-2A) vaccine administration. The patient was treated with oxygen and no medication was administered. 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.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Soreness injection site; The initial case was missing the following minimum criteria: unspecified product and adverse event. Upon receipt of follow-up information on 04Jan2021, this case now contains all required information to be considered valid.  This is a spontaneous report from a contactable healthcare professional, the patient, from a Pfizer sponsored program. A 63-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN), via an unspecified route of administration in the arm on 23Dec2020 (at the age of 63-years-old) as a single dose for COVID-19 immunization.   Medical history included penicillin allergy and anaphylaxis to a penicillin type drug. The patient's concomitant medications were not reported.  The patient previously took ampicillin (MANUFACTURER UNKNOWN) from an unknown date to an unknown date for an unknown indication and experienced drug allergy.  On 23Dec2020, the patient experienced soreness at injection site. The patient did not receive any treatment for the event. The clinical outcome of the soreness at injection site was recovered in Dec2020 after about 48 hours. The reporter considered that there was a reasonable possibility that the soreness at the injection site was related to the vaccine.   The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Erythema, Vaccination site induration, Vaccination site pain, Vaccination site warmth
Clinical narrative: site soreness; arm is starting to get red with an induration under the injection site; arm is starting to get red with an induration under the injection site; The site was warm; This is a spontaneous report from a contactable other health professional.  A male patient of an unspecified age received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), Batch/lot number: EL0140, via an unspecified route of administration in the right deltoid from 23Dec2020 at a SINGLE DOSE for covid-19 immunization. The patient's medical history was not reported.  Concomitant medication included atorvastatin (LIPITOR).  The patient experienced site soreness. He also indicated that his arm was starting to get red with an induration under the injection site. The site was warm. Outcome of events was unknown. No treatment was required/received due to events.  No follow-up attempts possible. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Odynophagia, Oropharyngeal pain, Throat irritation
Clinical narrative: my throat is extremely painful; it hurts to swallow; my throat started feeling a little scratchy 2 hours after receiving the vaccine; This is a spontaneous report from a contactable consumer (patient).  A 45-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), via an unspecified route of administration into the left deltoid on 02Jan2021 at 10:00 as singe dose for covid-19 immunization.  The patient's medical history and concomitant medications were not reported.  The patient reported  " my throat is extremely painful "  on 02Jan2021 with outcome of unknown; " it hurts to swallow on 02Jan2021 with outcome of unknown;  " my throat started feeling a little scratchy 2 hours after receiving the vaccine "  on 02Jan2021 with outcome of unknown.  The events were detailed as follows:  patient received her 1st vaccine, then described the following:  I feel ok but my throat is extremely painful and it hurts to swallow. My throat started feeling a little scratchy 2 hours after receiving the vaccine. Therapeutic measures were taken as a result of the events and included ibuprofen (ADVIL) 400 mg orally at 2:30 pm, helped some and was also reported as hurting more now because she needed to take more medicine. The outcome of events was unknown.   The batch/lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up .