chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test normal, Tinnitus, Tremor
Clinical narrative: dizzy; felt like I was going to pass out; shaky; ringing in ears; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via intramuscular route of administration on the left arm on 30Dec2020 17:00 at a single dose for COVID-19 immunization at hospital facility. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks, or any other medications within 2 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported "almost immediately, dizzy, felt like I was going to pass out, shaky, and ringing in ears" on 30Dec2020 17:00. Events were reported as non-serious but resulted in visit to the Emergency room/department or urgent care. Ondansetron (ZOFRAN) was given as treatment for nausea and meclizine. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "dizzy, felt like I was going to pass out, shaky, and ringing in ears" and the administration of COVID 19 vaccine, BNT162B2, based on the plausible temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Tinnitus, Tremor
Clinical narrative: dizzy; felt like I was going to pass out; shaky; ringing in ears; This is a spontaneous report from a contactable nurse (patient herself). A 63-year-old non-pregnant female patient received her first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, lot number: unknown), via intramuscular route of administration on the left arm on 30Dec2020 17:00 at a single dose for COVID-19 immunization at hospital facility. The patient had no relevant medical history and no known allergies. The patient's concomitant medications were not reported. The patient did not receive any other vaccines within 4 weeks, or any other medications within 2 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. The patient reported "almost immediately, dizzy, felt like I was going to pass out, shaky, and ringing in ears" on 30Dec2020 17:00. Events were reported as non-serious but resulted in visit to the Emergency room/department or urgent care. Ondansetron (ZOFRAN) was given as treatment for nausea and meclizine. The outcome of the events was not recovered. Since the vaccination, the patient had not been tested for COVID-19.  Information on the lot/batch number has been requested.; Sender's Comments: The Company cannot completely exclude the possible causality between the reported "dizzy, felt like I was going to pass out, shaky, and ringing in ears" and the administration of COVID 19 vaccine, BNT162B2, based on the plausible temporal association.   The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to RA, IEC, as appropriate.
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea
Clinical narrative: instant severe nausea lasting until mid morning on 1/8 1 hr later swelling of the eye lids and lips 25mg Benadryl taken before the shot and after the onset of the swelling of eyes and lips
Age: 63.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Lip swelling, Nausea
Clinical narrative: instant severe nausea lasting until mid morning on 1/8 1 hr later swelling of the eye lids and lips 25mg Benadryl taken before the shot and after the onset of the swelling of eyes and lips
Sex: F
Vaccine: PPV, UNK
Symptoms: Anaphylactic reaction, Cyst, Cyst removal
Clinical narrative: anaphylactic reaction; cyst develop on her arm from the pneumonia vaccine; This is a spontaneous report from a contactable healthcare professional (patient herself). A female patient of an unspecified age (reported patient age: 68, unit unspecified) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date in 2011 (reported as '10 years ago') at a single dose for immunization. Medical history included being allergic to tomato, potato, eggplant, cayenne, chili pepper, paprika, whole wheat, and egg albumin; multiple sclerosis, and being immunocompromised (taking immunosuppressants). The patient's concomitant medications were not reported. The patient previously took aluminum, diphenhydramine (BENADRYL), albendazole (BENZOL), and clindamycin and was allergic. She also took interferon beta-1a (AVONEX). The patient reported that she received a pneumonia vaccine, 10 years ago, in which she had an anaphylactic reaction to that resulted in self medicating with an antihistamine. She stated that she had a cyst develop on her arm from the pneumonia vaccine that had to be surgically removed. She also stated that she cannot take the normal flu vaccine. The outcome of events was unknown.   Information regarding the batch/lot number has been requested.; Sender's Comments: Based on the implied time association, the possible contribution of suspect pneumococcal 13-valent conjugate vaccine injection to the events anaphylactic reaction and vaccination site cyst cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: PPV, UNK
Symptoms: Anaphylactic reaction, Cyst removal, Vaccination site cyst
Clinical narrative: anaphylactic reaction; cyst develop on her arm from the pneumonia vaccine; This is a spontaneous report from a contactable healthcare professional (patient herself). A female patient of an unspecified age (reported patient age: 68, unit unspecified) received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein, lot number and expiry date were not reported), via an unspecified route of administration on an unspecified date in 2011 (reported as '10 years ago') at a single dose for immunization. Medical history included being allergic to tomato, potato, eggplant, cayenne, chili pepper, paprika, whole wheat, and egg albumin; multiple sclerosis, and being immunocompromised (taking immunosuppressants). The patient's concomitant medications were not reported. The patient previously took aluminum, diphenhydramine (BENADRYL), albendazole (BENZOL), and clindamycin and was allergic. She also took interferon beta-1a (AVONEX). The patient reported that she received a pneumonia vaccine, 10 years ago, in which she had an anaphylactic reaction to that resulted in self medicating with an antihistamine. She stated that she had a cyst develop on her arm from the pneumonia vaccine that had to be surgically removed. She also stated that she cannot take the normal flu vaccine. The outcome of events was unknown.   Information regarding the batch/lot number has been requested.; Sender's Comments: Based on the implied time association, the possible contribution of suspect pneumococcal 13-valent conjugate vaccine injection to the events anaphylactic reaction and vaccination site cyst cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site cellulitis, Vertigo
Clinical narrative: On the afternoon/evening of 1/7/2021 my arm became sore around the injection site. It was also a little red. On 1/8/2021 @ 1:30am I woke up with nausea,  chills and my arm was swollen, red, hot to touch. I took tylenol and went back to sleep. When I got up around 6am that morning my symptoms were worse. I went to the emergency room at this time. I was treated there for cellulitis with IV ceftriaxone and prescribed a 10 day course of cefdinir. It is slowly getting better, however, I had to return to urgent care yesterday due to increase in redness and have now been presribed prednisone and will also finish antibiotics.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cellulitis, Chills, Condition aggravated, Injection site erythema, Injection site pain
Clinical narrative: On the afternoon/evening of 1/7/2021 my arm became sore around the injection site. It was also a little red. On 1/8/2021 @ 1:30am I woke up with nausea,  chills and my arm was swollen, red, hot to touch. I took tylenol and went back to sleep. When I got up around 6am that morning my symptoms were worse. I went to the emergency room at this time. I was treated there for cellulitis with IV ceftriaxone and prescribed a 10 day course of cefdinir. It is slowly getting better, however, I had to return to urgent care yesterday due to increase in redness and have now been presribed prednisone and will also finish antibiotics.
Age: 40.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site swelling, Injection site warmth, Laboratory test, Nausea, X-ray
Clinical narrative: On the afternoon/evening of 1/7/2021 my arm became sore around the injection site. It was also a little red. On 1/8/2021 @ 1:30am I woke up with nausea,  chills and my arm was swollen, red, hot to touch. I took tylenol and went back to sleep. When I got up around 6am that morning my symptoms were worse. I went to the emergency room at this time. I was treated there for cellulitis with IV ceftriaxone and prescribed a 10 day course of cefdinir. It is slowly getting better, however, I had to return to urgent care yesterday due to increase in redness and have now been presribed prednisone and will also finish antibiotics.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Eye swelling, Fatigue, Peripheral swelling, Swelling face
Clinical narrative: wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling and pain  thursday night-more dyspnea, joint pain, general swelling, joint pain (took tylenol worked shift as nurse) friday-fatigue, joint swelling, general swelling, dyspnea blanching (took tylenol and ibuprofen worked shift as nurse) saturday-extreme fatigue, joint pain and swelling, general swelling, dyspnea sunday, facial swelling, petichiae on legs and back, joint,  pain and swelling, fatigue requiring visit to hospital
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, C-reactive protein, Chest X-ray, Dyspnoea, Fatigue
Clinical narrative: wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling and pain  thursday night-more dyspnea, joint pain, general swelling, joint pain (took tylenol worked shift as nurse) friday-fatigue, joint swelling, general swelling, dyspnea blanching (took tylenol and ibuprofen worked shift as nurse) saturday-extreme fatigue, joint pain and swelling, general swelling, dyspnea sunday, facial swelling, petichiae on legs and back, joint,  pain and swelling, fatigue requiring visit to hospital
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Joint swelling, Laboratory test, Pallor, Petechiae, Swelling
Clinical narrative: wednesday-dyspnea on exertion(took tylenol worked shift as nurse) thursday morning-joint swelling and pain  thursday night-more dyspnea, joint pain, general swelling, joint pain (took tylenol worked shift as nurse) friday-fatigue, joint swelling, general swelling, dyspnea blanching (took tylenol and ibuprofen worked shift as nurse) saturday-extreme fatigue, joint pain and swelling, general swelling, dyspnea sunday, facial swelling, petichiae on legs and back, joint,  pain and swelling, fatigue requiring visit to hospital
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Flushing, Heart rate increased, Peripheral swelling, Swelling
Clinical narrative: Immediately felt "strange" after receiving the vaccination.  Developed hypertension, muscle aches, extremity swelling.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Feeling abnormal, Hypertension, Myalgia, Peripheral swelling
Clinical narrative: Immediately felt "strange" after receiving the vaccination.  Developed hypertension, muscle aches, extremity swelling.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Facial paralysis, Fatigue, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: DESCRIBED " FIRST SHOT ON 01/08/2021-GOT A SORE ARM AND FATIGUE-BUT STARTING ON SATURDAY I NOTICED MY FACE WOULD BE TINGLY AND NUMB FEELING-THEN ON SUNDAY HAD DROOPING OF RIGHT EYE LID WHEN I WAS TIRED-I NOW HAD SOME DROOPING OF MY MOUTH, ONLY SMOETIMES, AND MY EYE LID WHEN I AM TIRED. THE NUMB FEELING IS STILL THERE.:
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Extraocular muscle paresis, Facial paralysis, Fatigue, Hypoaesthesia
Clinical narrative: DESCRIBED " FIRST SHOT ON 01/08/2021-GOT A SORE ARM AND FATIGUE-BUT STARTING ON SATURDAY I NOTICED MY FACE WOULD BE TINGLY AND NUMB FEELING-THEN ON SUNDAY HAD DROOPING OF RIGHT EYE LID WHEN I WAS TIRED-I NOW HAD SOME DROOPING OF MY MOUTH, ONLY SMOETIMES, AND MY EYE LID WHEN I AM TIRED. THE NUMB FEELING IS STILL THERE.:
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Muscular weakness, Paraesthesia
Clinical narrative: DESCRIBED " FIRST SHOT ON 01/08/2021-GOT A SORE ARM AND FATIGUE-BUT STARTING ON SATURDAY I NOTICED MY FACE WOULD BE TINGLY AND NUMB FEELING-THEN ON SUNDAY HAD DROOPING OF RIGHT EYE LID WHEN I WAS TIRED-I NOW HAD SOME DROOPING OF MY MOUTH, ONLY SMOETIMES, AND MY EYE LID WHEN I AM TIRED. THE NUMB FEELING IS STILL THERE.:
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Injection site urticaria, Oropharyngeal pain, Pain
Clinical narrative: Hives around injection site on evening of 1/7.  I was tired with a head ache on 1/8.  1/9 I had hives on my back and stomach starting around noon.  I took Benadryl.  I was extremely fatigued and have been since. I have since developed flu/ COVID like symptoms (headache, body ache, runny nose, extreme fatigue, sore throat) I was tested on 1/11 for COVID.  It came back negative.  I had hives again 1/12 and took benadryl.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Respiratory tract congestion, Rhinorrhoea, SARS-CoV-2 test, Urticaria
Clinical narrative: Hives around injection site on evening of 1/7.  I was tired with a head ache on 1/8.  1/9 I had hives on my back and stomach starting around noon.  I took Benadryl.  I was extremely fatigued and have been since. I have since developed flu/ COVID like symptoms (headache, body ache, runny nose, extreme fatigue, sore throat) I was tested on 1/11 for COVID.  It came back negative.  I had hives again 1/12 and took benadryl.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Injection site urticaria, Oropharyngeal pain
Clinical narrative: Hives around injection site on evening of 1/7.  I was tired with a head ache on 1/8.  1/9 I had hives on my back and stomach starting around noon.  I took Benadryl.  I was extremely fatigued and have been since. I have since developed flu/ COVID like symptoms (headache, body ache, runny nose, extreme fatigue, sore throat) I was tested on 1/11 for COVID.  It came back negative.  I had hives again 1/12 and took benadryl.
Age: 32.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain, Rhinorrhoea, SARS-CoV-2 test negative
Clinical narrative: Hives around injection site on evening of 1/7.  I was tired with a head ache on 1/8.  1/9 I had hives on my back and stomach starting around noon.  I took Benadryl.  I was extremely fatigued and have been since. I have since developed flu/ COVID like symptoms (headache, body ache, runny nose, extreme fatigue, sore throat) I was tested on 1/11 for COVID.  It came back negative.  I had hives again 1/12 and took benadryl.
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Paraesthesia, Pruritus, Throat irritation, Tongue pruritus
Clinical narrative: Right arm tingling, right hand itching, left hand itching. Frontal headache. Tongue, facial itching, "something catching in throat"
Age: 25.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Paraesthesia, Pruritus, Throat tightness, Tongue pruritus
Clinical narrative: Right arm tingling, right hand itching, left hand itching. Frontal headache. Tongue, facial itching, "something catching in throat"
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Rash
Clinical narrative: Per pt Peg allergy; contacted Moderna prior to vaccination, Moderna advised to pre-dosed with Benadryl 30 prior to vaccination.  In evening after vaccination feeling itching on back of arms.  Sunday night to Monday AM, full body rash   1/10/21 - 1/11/21 on thighs,  knees, elbow, chest and top back of arms and all joint swelling red and hot; rash was intense red sunburn like. shooting pain in thigh; swollen joints and extremities, intensified and symptoms worsen. On Monday 1/11/21  , Pt returned for med treatment , because of heat from joints pt was then sent via car transportation to  ER -- Epipen prescribed and prednisone, also Benadryl
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Joint swelling, Pruritus, Rash, Skin warm
Clinical narrative: Per pt Peg allergy; contacted Moderna prior to vaccination, Moderna advised to pre-dosed with Benadryl 30 prior to vaccination.  In evening after vaccination feeling itching on back of arms.  Sunday night to Monday AM, full body rash   1/10/21 - 1/11/21 on thighs,  knees, elbow, chest and top back of arms and all joint swelling red and hot; rash was intense red sunburn like. shooting pain in thigh; swollen joints and extremities, intensified and symptoms worsen. On Monday 1/11/21  , Pt returned for med treatment , because of heat from joints pt was then sent via car transportation to  ER -- Epipen prescribed and prednisone, also Benadryl
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Eye swelling, Flushing, Throat tightness
Clinical narrative: after vaccine felt flush with throat tightness, quickly resolved then repeat episode at 30 minutes, given Benadryl 25mg PO and observed for another 30 minutes, at 4pm eyes were swollen, given another 25mg PO and paramedics were called, sent to Hospital.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Antibody test, Conjunctivitis allergic, Disease recurrence, Feeling abnormal, Fungal infection
Clinical narrative: increased respiratory infection; Allergic reaction; Yeast infection; Non-diagnosed allergic conjunctivitis; seasonal allergies; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs), from a contactable nurse (patient) reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was having an allergic reaction and had a yeast infection. She was supposed to get the next dose soon (on 12Jan2021) but she was worried about getting the second dose. The patient stated so she had some increased (incomplete sentence).The patient stated she had a non-diagnosed allergic conjunctivitis followed by a yeast infection, followed by increased respiratory infection and she did make a report of the seasonal allergies that I did not used to get at this time of year. So, she did not report the conjunctivitis because it was not diagnosed and did not report the yeast infection because she handled it herself. The outcome of events was unknown.   Information about Lot/Batch number is requested.; Sender's Comments: Based solely on a compatible temporal association causality between reported events and BNT162B2 vaccine cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Irritability postvaccinal, SARS-CoV-2 test, Seasonal allergy, Skin test
Clinical narrative: increased respiratory infection; Allergic reaction; Yeast infection; Non-diagnosed allergic conjunctivitis; seasonal allergies; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs), from a contactable nurse (patient) reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was having an allergic reaction and had a yeast infection. She was supposed to get the next dose soon (on 12Jan2021) but she was worried about getting the second dose. The patient stated so she had some increased (incomplete sentence).The patient stated she had a non-diagnosed allergic conjunctivitis followed by a yeast infection, followed by increased respiratory infection and she did make a report of the seasonal allergies that I did not used to get at this time of year. So, she did not report the conjunctivitis because it was not diagnosed and did not report the yeast infection because she handled it herself. The outcome of events was unknown.   Information about Lot/Batch number is requested.; Sender's Comments: Based solely on a compatible temporal association causality between reported events and BNT162B2 vaccine cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Conjunctivitis allergic, Fungal infection, Hypersensitivity, Respiratory tract infection
Clinical narrative: increased respiratory infection; Allergic reaction; Yeast infection; Non-diagnosed allergic conjunctivitis; seasonal allergies; This is a spontaneous report from a Pfizer-sponsored program, IBCC (Inbound Call Center for HCPs), from a contactable nurse (patient) reported for herself. A female patient of an unspecified age received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) via an unspecified route of administration on 22Dec2020 at a single dose for COVID-19 immunization. Medical history and concomitant medications were not reported. The patient was having an allergic reaction and had a yeast infection. She was supposed to get the next dose soon (on 12Jan2021) but she was worried about getting the second dose. The patient stated so she had some increased (incomplete sentence).The patient stated she had a non-diagnosed allergic conjunctivitis followed by a yeast infection, followed by increased respiratory infection and she did make a report of the seasonal allergies that I did not used to get at this time of year. So, she did not report the conjunctivitis because it was not diagnosed and did not report the yeast infection because she handled it herself. The outcome of events was unknown.   Information about Lot/Batch number is requested.; Sender's Comments: Based solely on a compatible temporal association causality between reported events and BNT162B2 vaccine cannot be excluded. The case will be reevaluated should additional information become available. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Back pain, Chest pain, Grip strength decreased, Hypoaesthesia
Clinical narrative: Left arm sore, redness, swelling, numbness, tingling, decrease grip strength, painful,ollen glands in arm pit.  Insomnia
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Oedema peripheral, Sleep disorder
Clinical narrative: Left arm sore, redness, swelling, numbness, tingling, decrease grip strength, painful,ollen glands in arm pit.  Insomnia
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Axillary pain, Erythema, Grip strength decreased, Hypoaesthesia, Insomnia
Clinical narrative: Left arm sore, redness, swelling, numbness, tingling, decrease grip strength, painful,ollen glands in arm pit.  Insomnia
Age: 29.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Left arm sore, redness, swelling, numbness, tingling, decrease grip strength, painful,ollen glands in arm pit.  Insomnia
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypertension, Tachycardia, Throat tightness
Clinical narrative: Was unable to swallow, breathing was not affected.  Throat muscles felt weaken.   Was given a Benadryl, symptoms resolved soon after.
Age: 42.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dysphagia, Dyspnoea, Muscular weakness
Clinical narrative: Was unable to swallow, breathing was not affected.  Throat muscles felt weaken.   Was given a Benadryl, symptoms resolved soon after.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Pruritus
Clinical narrative: Redness, rash, and itching on face, chest, neck, shoulders within 10 mins of injection.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Injection site rash, Pruritus
Clinical narrative: Redness, rash, and itching on face, chest, neck, shoulders within 10 mins of injection.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Rash
Clinical narrative: Redness, rash, and itching on face, chest, neck, shoulders within 10 mins of injection.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Malaise, Throat irritation, Throat tightness
Clinical narrative: Patient checked in at observation area at 1247pm first dose Moderna post COVID-19 vaccine. Went in to check at patient at 1259pm sitting on chair on tripod position. I asked her how she is feeling. She said her throat feels itchy. Took patient to gurney to lay down and afterwards started saying that her throat feels like it is closing up. Called for RRT, Epi was given at 1300 and O2 provided. Ptient started yelling "Oh my god I am not feeling well" MD at bedside doing assessment. RRT at arrived, hand off given. Patient was taken down to ED via wheelchair by RRT nurse at 1315.  Vital signs as follows:  13:05- BP=145/84, HR=135, RR=26, O2 sats 100 at 15li/FM then switch to room air.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Throat irritation, Throat tightness
Clinical narrative: Patient checked in at observation area at 1247pm first dose Moderna post COVID-19 vaccine. Went in to check at patient at 1259pm sitting on chair on tripod position. I asked her how she is feeling. She said her throat feels itchy. Took patient to gurney to lay down and afterwards started saying that her throat feels like it is closing up. Called for RRT, Epi was given at 1300 and O2 provided. Ptient started yelling "Oh my god I am not feeling well" MD at bedside doing assessment. RRT at arrived, hand off given. Patient was taken down to ED via wheelchair by RRT nurse at 1315.  Vital signs as follows:  13:05- BP=145/84, HR=135, RR=26, O2 sats 100 at 15li/FM then switch to room air.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Flushing, Paraesthesia oral
Clinical narrative: 5-7 min after injection began feeling burning sensation over entire body. Followed by dizziness, tingling lips and tongue swelling. Became foggy feeling and sense of ?impending doom?
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Anxiety, Burning sensation, Dizziness, Feeling abnormal, Hypersensitivity
Clinical narrative: 5-7 min after injection began feeling burning sensation over entire body. Followed by dizziness, tingling lips and tongue swelling. Became foggy feeling and sense of ?impending doom?
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia oral, Swollen tongue
Clinical narrative: 5-7 min after injection began feeling burning sensation over entire body. Followed by dizziness, tingling lips and tongue swelling. Became foggy feeling and sense of ?impending doom?
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Abdominal pain, Anxiety, Burning sensation, Diarrhoea, Dizziness
Clinical narrative: 5-7 min after injection began feeling burning sensation over entire body. Followed by dizziness, tingling lips and tongue swelling. Became foggy feeling and sense of ?impending doom?
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Feeling abnormal, Paraesthesia oral, Swollen tongue
Clinical narrative: 5-7 min after injection began feeling burning sensation over entire body. Followed by dizziness, tingling lips and tongue swelling. Became foggy feeling and sense of ?impending doom?
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Pain in extremity, Rhinorrhoea, Throat irritation, Throat tightness
Clinical narrative: Nauseated & on verge of vomiting, went to ER and received Epinepheline. Symptoms resolved within a few hours
Age: 31.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: Nauseated & on verge of vomiting, went to ER and received Epinepheline. Symptoms resolved within a few hours
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthma, Brain natriuretic peptide normal, Chest X-ray abnormal, Dyspnoea, Full blood count normal
Clinical narrative: Patient noted periorbital swelling about 1 hr after the vaccine and was sent to ED.  She had some mild asthma symptoms earlier in the day (before vaccination) and these did not worsen after the vaccination.  She did not have throat tightness, chest pain, dizziness, rash, itching.  She has hx asthma, GERD.  She has allergy to sulfa and cipro (Rash) and Prozac (psychosis).  In ED, patient was given IV benadryl and famotidine and discharged with Rx methylprednisolone and epipen.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Metabolic function test, Periorbital swelling, Troponin normal, Urticaria
Clinical narrative: Patient noted periorbital swelling about 1 hr after the vaccine and was sent to ED.  She had some mild asthma symptoms earlier in the day (before vaccination) and these did not worsen after the vaccination.  She did not have throat tightness, chest pain, dizziness, rash, itching.  She has hx asthma, GERD.  She has allergy to sulfa and cipro (Rash) and Prozac (psychosis).  In ED, patient was given IV benadryl and famotidine and discharged with Rx methylprednisolone and epipen.
Age: 54.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Periorbital swelling
Clinical narrative: Patient noted periorbital swelling about 1 hr after the vaccine and was sent to ED.  She had some mild asthma symptoms earlier in the day (before vaccination) and these did not worsen after the vaccination.  She did not have throat tightness, chest pain, dizziness, rash, itching.  She has hx asthma, GERD.  She has allergy to sulfa and cipro (Rash) and Prozac (psychosis).  In ED, patient was given IV benadryl and famotidine and discharged with Rx methylprednisolone and epipen.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: After my first dose, the only symptom I had was soreness at the injection site lasting 1 day. 12 hours after my second vaccine, I developed muscle aches and chills that were gone the following morning when I woke up. 3 days after receiving my second dose, I developed hives and swelling on my entire body that progressed over 2 days. I also started to have some swelling in my throat by 4 days after the second dose and ended up going to immediate care for a steroid injection which began to provide relief by the next morning.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Myalgia, Pharyngeal swelling, Swelling, Urticaria
Clinical narrative: After my first dose, the only symptom I had was soreness at the injection site lasting 1 day. 12 hours after my second vaccine, I developed muscle aches and chills that were gone the following morning when I woke up. 3 days after receiving my second dose, I developed hives and swelling on my entire body that progressed over 2 days. I also started to have some swelling in my throat by 4 days after the second dose and ended up going to immediate care for a steroid injection which began to provide relief by the next morning.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills at night; Tiredness; This is a spontaneous report from a contactable physician (patient). A 48-year-old male patient received the first dose of BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) on 16Dec2020 (Lot number and expiration date were not reported), and the second dose on 05Jan2021 (Lot number: EL3246; Expiration date was not reported), both at a single dose, with route of administration unspecified, for COVID-19 immunization. Medical history included ongoing hypertension and ongoing hypercholesterolaemia; both diagnosed more than 10 years ago. There were no concomitant medications. On 06Jan2021, the patient had chills at night and tiredness. The outcome of the events, chills at night and tiredness, was recovered on 06Jan2021.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Tiredness; This is a spontaneous report from a contactable physician (patient). A 48-year-old male patient received the first dose of bnt162b2 (also reported as COVID 19 vaccine, lot number and expiry date were unknown), via an unspecified route of administration on 16Dec2020 at single dose for Covid-19 immunization. Medical history included hypertension and hypercholesterolaemia; both were diagnosed more than 10 years ago and ongoing. There were no concomitant medications. The patient received his first dose of bnt162b2 on 16Dec2020. He doesn't have the lot number for that one. With his first dose he experienced tiredness on unspecified date, but the second dose was worse. The hospital staff get the vaccine. He is always in contact with patients with COVID. The outcome of the event was unknown.  Information on the lot/batch number has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Several patients were administered PROQUAD during this temperature excursion.; This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.  On 04-DEC-2020, the patient was vaccinated with an improperly stored Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) 0.5 milliliter (route of administration was not reported), lot number T021302 rHA and expiration date 19-DEC-2021 administered as prophylaxis.  The improperly stored dose of the suspect vaccine experienced a temperature excursion of -5 degree Celsius (°C) for 20 hours; no previous temperature excursion were reported.  The call was made due to a digital data logger.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: Several patients were administered PROQUAD during this temperature excursion; This spontaneous report was received from a register nurse referring to patient of unknown age and gender. Information regarding the patient's concomitant therapies, concurrent conditions, medical history and historical drugs was not provided.   On an unspecified date in 2020, the patient was vaccinated with 0.5 ml of an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (rHA) (PROQUAD) lot # T021302, expiration date 19-DEC-2021 for prophylaxis  (frequency and route of administration were not reported) (product storage error).  The improperly stored suspect vaccine experienced one temperature excursion of - 5 Celsius degrees (°C) for 20 hours. The call was made due to a digital data logger. No previous temperature excursion was reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE/PQCs reported; administration of improperly stored PROQU AD.; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 24-AUG-2020, the patient was vaccinated with an improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rha) (PROQUAD) lot # T015598, expiration date 02-NOV-2021 for prophylaxis (dose, vaccination scheme frequency, route of administration and anatomical site of vaccination were not reported). No additional adverse events reported.   The vaccine was stored in a temperature of 20.5 degree Fahrenheit (°F) for 1 hour 54 minutes as recorded by a data logger. There was a previous temperature excursion of 6°F to 14°F (12.3F) for 23 hours reported.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: No additional AE reported; expired MMR II was administered, to a patient. The HCP stated that the vaccine expired 10/3/2020.; This spontaneous report was received from a nurse and a medical assistant and refers to a 4 year old patient of unknown gender. No information about the patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions or allergies was provided.  On 20-DEC-2020, the patient was vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) albumin status rHA, 0.5 ml , lot # R028381 with expiration date of 03-OCT-2020, for prophylaxis (route of administration was not provided). No adverse event occurred.    No temperature excursions occurred.
Age: 5.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE details available at this time; Temperature excursion; This spontaneous report has been received from a registered nurse concerning a 5 years-old patient. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.       On 11-DEC-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml,  Lot # T021638, expiration date reported as 21-FEB-2021 but upon internal validation established as 21-DEC-2021 for prophylaxis.  The temperature was reported to had been at  -13.3°Celsius(C) for a period of 4 hours and 15 minutes.  No other adverse events details were available at this time.  There was digital data logger involved and  no previous temperature excursion was reported.
Age: 1.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE details available at this time; Temperature excursion; This spontaneous report has been received from a registered nurse concerning a 12 months old patient of unknown gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.       On 11-DEC-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml,  Lot # T017688, expiration date 21-MAY-2022 for prophylaxis.  The temperature was reported to had been at -13.3°Celsius(C) for a period of 4 hours and 15 minutes.  No other adverse events details were available at this time.  There was digital data logger involved and no previous temperature excursion was reported.
Age: 4.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other AE details available at this time; Temperature excursion; This spontaneous report has been received from a registered nurse concerning a 4 years-old patient of unknown gender. The patient's concurrent conditions, historical drugs, medical history and concomitant therapies were not reported.       On 04-DEC-2020, the patient was vaccinated with an improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD) 0.5 ml,  Lot # T021638, expiration date reported as 21-FEB-2021 but upon internal validation established as 21-DEC-2021 for prophylaxis.  The temperature was reported to had been at -13.3°Celsius(C) for a period of 4 hours and 15 minutes.  No other adverse events details were available at this time.  There was digital data logger involved and no previous temperature excursion was reported.
Age: 1.42
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccine administered; This spontaneous report as received from a registered nurse refers to a 17-month-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 23-FEB-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: T017688, expiration date: 21-MAY-2022), 0.5 ml (route of administration was not provided). The vaccine was stored in temperature -13.3 degrees Celsius for 4 hours and 15 minutes. There was no previous temperature excursion. Digital data lodger was involved.  This is one of 23 reports from the same reporter.; Sender's Comments:  US-009507513-2012USA013093: US-009507513-2012USA013095: US-009507513-2012USA013524: US-009507513-2012USA013532: US-009507513-2012USA013533: US-009507513-2012USA013584: US-009507513-2012USA013585: US-009507513-2012USA013592: US-009507513-2012USA013594: US-009507513-2012USA013596: US-009507513-2012USA013598: US-009507513-2012USA013601: US-009507513-2012USA013603: US-009507513-2101USA000121: US-009507513-2101USA000122: US-009507513-2101USA000144: US-009507513-2101USA000214: US-009507513-2101USA000235: US-009507513-2101USA000261: US-009507513-2101USA000265: US-009507513-2101USA000266: US-009507513-2101USA000307:
Age: 0.17
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccine administered; age at vaccine administration: 11 weeks; This spontaneous report as received from a registered nurse refers to a 11-week-old patient of unknown gender. Pertinent medical history, drug reactions, allergies and concomitant medications were not reported.  On 03-FEB-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot number: T017688, expiration date: 21-MAY-2022), 0.5 ml (route of administration was not provided) (inappropriate age at vaccine administration). The vaccine was stored in temperature -13.3 degrees Celsius for 4 hours and 15 minutes. There was no previous temperature excursion. Digital data lodger was involved.  This is one of 23 reports from the same reporter.; Sender's Comments:  US-009507513-2012USA013093: US-009507513-2012USA013095: US-009507513-2012USA013524: US-009507513-2012USA013532: US-009507513-2012USA013533: US-009507513-2012USA013584: US-009507513-2012USA013585: US-009507513-2012USA013592: US-009507513-2012USA013594: US-009507513-2012USA013596: US-009507513-2012USA013598: US-009507513-2012USA013601: US-009507513-2012USA013603: US-009507513-2101USA000121: US-009507513-2101USA000122: US-009507513-2101USA000144: US-009507513-2101USA000214: US-009507513-2101USA000235: US-009507513-2101USA000261: US-009507513-2101USA000265: US-009507513-2101USA000266: US-009507513-2101USA000304:
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: the vaccine was administered to patient during the excursion; This spontaneous report was received from a nurse referring to a patient of unknown age. Information regarding the patient's pertinent medical history, historical drugs, concurrent conditions, concomitant therapies, and previous drug reactions or allergies was not reported.      On 21-DEC-2020, the patient was vaccinated with an improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) lot # 1658255, expiration date 07-FEB-2021, at a dose of 2 milliliter, orally for prophylaxis (vaccination scheme frequency not reported). No additional details reported.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: No additional AE; Improperly Stored ROTATEQ was administered to patient; This spontaneous report was received from a nurse referring to a 6-month-old patient of unknown gender. The patient's medical history, historical drugs, concurrent conditions and concomitant medications were not provided.       On 06-JAN-2021, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) 1 dosage form, orally, lot number 1691133 and expiration date 28-NOV-2021 for prophylaxis. No additional adverse events were reported.  The vaccine underwent a temperature excursion of 35.2 degrees Fahrenheit (°F) for 45 minutes (occurred at 1:30 am). There were no previous temperature excursions. The call was due to digital data logger.  This is one of 2 cases reported by the same nurse; Sender's Comments:  US-009507513-2101USA003974:
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Her 18 y/o son who received the 2nd dose of GARDASIL 9 one month later; This spontaneous report was received from a nurse referring to her son, a 18 year old male patient. The patient's pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not provided.      Approximately in September 2020, the patient received the first dose of  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strenght, dose, route of administration, anatomical location, lot # and expiration date were unknown). Then, one month later, probably in October 2020 (as the patient's mother was not certain), the patient was vaccinated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (strenght, dose, route of administration, anatomical location, lot # and expiration date were unknown).