chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This 13-year-old patient inadvertently received a pediatric dose of Pfizer (10 mcg/0.2 mL) which is approved for ages 5-11.  Patient was observed for the recommended 15 minutes with no adverse reactions.  This was the third dose for the patient; the first 2 doses were the Pfizer (purple cap) for 12+.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives daily, which increased in severity after receiving the second vaccine (pfizer) on 12/29/2022. Hives covered the entirety of the body. The hives would last about 24 hours, in which new ones would appear as the old ones begin to disappear. Severity ranges day to day.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Bacterial vaginosis, Fungal infection, Laboratory test
Clinical narrative: Dose 1: 12/21/20 Dose 2: 1/11/21 Booster (dose 3) 10/9/21 End of 10/21 diagnosed with bacterial vaginosis (first ever diagnosis for individual), treated with Metrogel 1/13/22 diagnosed with yeast infection (first ever diagnosis for individual), treated with Diflucan
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Deafness, Ear discomfort, Tinnitus
Clinical narrative: loss of hearing in left ear, approx 30-40 reduction, buzzing, pressure in ear
Age: 31.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Joint swelling, Pain in extremity, Rash pruritic, Urticaria
Clinical narrative: Super itchy body rash all over body. Hives/urticaria. Ongoing  for 5 days at point of filing this report(still ongoing). Swollen wrists, knees and ankles. Joint pain in fingers, wrists, knees and ankles.  Still ongoing. Prescribed allergy meds.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Blood test, Dermatologic examination, Erythema, Pruritus, Rash papular
Clinical narrative: I received my second dose of the Pfizer vaccine in April 2021 and about 3 weeks later (May 2021)  I start developing hives. Uncontrollable hives all over my body, from head to toe. The hives are completely sporadic and can appear anywhere at any time. The hives are raised bumps, red, and itchy. I have been to a dermatologist, an allergist, and a primary care doctor that cannot give me a clear explanation for my hives. The doctors asked me what has changed in my lifestyle since the hives appeared and the only thing that has changed is getting the second dose of the vaccine.  I am going on 9 months now struggling with these awful hives/itch every day with no hope in sight. The antihistamines (Zyrtec and Allegra) give me temporary relief but the hives always come back. I needed up in urgent care at one point since the hives were so severe that my foot and hands were swollen and the hives were causing me severe joint pain.
Age: 25.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Urticaria
Clinical narrative: I received my second dose of the Pfizer vaccine in April 2021 and about 3 weeks later (May 2021)  I start developing hives. Uncontrollable hives all over my body, from head to toe. The hives are completely sporadic and can appear anywhere at any time. The hives are raised bumps, red, and itchy. I have been to a dermatologist, an allergist, and a primary care doctor that cannot give me a clear explanation for my hives. The doctors asked me what has changed in my lifestyle since the hives appeared and the only thing that has changed is getting the second dose of the vaccine.  I am going on 9 months now struggling with these awful hives/itch every day with no hope in sight. The antihistamines (Zyrtec and Allegra) give me temporary relief but the hives always come back. I needed up in urgent care at one point since the hives were so severe that my foot and hands were swollen and the hives were causing me severe joint pain.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Confusional state, Dizziness, Fatigue, Headache
Clinical narrative: Fever, body aches, inability to sleep, extreme fatigue, upset stomach, dizziness, headache, confusion for about 14 hours.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Insomnia, Pain, Pyrexia
Clinical narrative: Fever, body aches, inability to sleep, extreme fatigue, upset stomach, dizziness, headache, confusion for about 14 hours.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Erythema, Fatigue, Oropharyngeal pain
Clinical narrative: Large lump with redness and warm to touch. Sore throat Heart felt heavy and pounding Shortness of breath Very fatigued
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Skin warm, Swelling
Clinical narrative: Large lump with redness and warm to touch. Sore throat Heart felt heavy and pounding Shortness of breath Very fatigued
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Urticaria
Clinical narrative: Hives, daily reoccurring, very itchy and sore continues over a week and not cleared up yet. Taking oral steroids and antihistamine.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Axillary pain, Back pain, Chest X-ray, Dyspnoea
Clinical narrative: After second vaccine - Pfizer Lot #EW0196 - I experienced Pleurisy, Shortness of breath, extreme fatigue, weakness, malaise, widespread Lymphadenopathy - Swollen lymph nodes under left armpit, left jawline and essentially a necklace of lymph nods popped out across chest and eventually both sides of neck, neck pain, headache, back pain, armpit pain, jaw pain.  This lasted for a few weeks.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Headache, Laboratory test, Lymphadenopathy, Malaise
Clinical narrative: After second vaccine - Pfizer Lot #EW0196 - I experienced Pleurisy, Shortness of breath, extreme fatigue, weakness, malaise, widespread Lymphadenopathy - Swollen lymph nodes under left armpit, left jawline and essentially a necklace of lymph nods popped out across chest and eventually both sides of neck, neck pain, headache, back pain, armpit pain, jaw pain.  This lasted for a few weeks.
Age: 43.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Neck pain, Pain in jaw, Pleurisy
Clinical narrative: After second vaccine - Pfizer Lot #EW0196 - I experienced Pleurisy, Shortness of breath, extreme fatigue, weakness, malaise, widespread Lymphadenopathy - Swollen lymph nodes under left armpit, left jawline and essentially a necklace of lymph nods popped out across chest and eventually both sides of neck, neck pain, headache, back pain, armpit pain, jaw pain.  This lasted for a few weeks.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: The patient registered her child with the birthday making the child 12 years old. She confirmed and signed that this was the patients birthday with the pharmacist and registering tech. Appointments cannot be made at our location for ages under 12 because we do not offer the pediatric vaccine. After recieiving the CDC cards the patients mother came and asked us to change the DOB to 2011 after the vaccine was given. We informed her that this was not the pediatric dose and that you cannot register at this location under 12 years old because we do not offer this dosage. The mother did not realize she had given the wrong birthday. We suggested she contact the childs pediatrician.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Palpitations.  Less severe over time mostly gone by 1-14-22
Age: 30.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pain
Clinical narrative: Severe body aches, chills, headache.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Loss of consciousness
Clinical narrative: The patient received the vaccine and I directed her and her mother to be seated for 15 minutes for observation. Shortly after that the mother approached me and asked if it was normal for a child to be dizzy and weak after the vaccine. She also said that her daughter passed out. I checked her BP and it was 74/53. Ten minutes later I checked it again and it was 84/56. Ten minutes after that it was 81/63. I recommended that we call 911 to be sure she was ok and the mother agreed. I called 911 and the fire department and then the ambulance came and took over.
Age: 55.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Hypoxia, Intensive care, Pulmonary embolism, Thrombectomy
Clinical narrative: 55 y.o. female in good health took the Moderna Vaccine & then experienced Hypoxia and a enormous saddle embolus in her lungs that had to be surgically removed. She was placed on Eliquis for lifetime. Clinic urges hospitalization into ICU & extraction of a HUGE saddle blood clot from her lungs.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event
Clinical narrative: NO ADVERSE EVENTS REPORTED
Age: 5.0
Sex: M
Vaccine: COVID19
Symptoms: Purpura, Urticaria
Clinical narrative: Hives generalized  B/L ankle purpura Central area
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus
Clinical narrative: Pain, erythema/enduration, itching at injection site Narrative:
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Myalgia, Pain
Clinical narrative: Headache, Myalgia, Chills, body aches, headache Narrative
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site erythema
Clinical narrative: Headache, Fever, Diarrhea, NauseaVomiting, injection site redness/swelling/pain/itching, fatigue Narrative:  Employee reports injection site redness/swelling/pain/itching, fatigue, headaches, chills (x 1 night, 1 week after vaccine), fatigue, and "some" nausea/vomiting/diarrhea. Notes itching was "intense." Also notes more local symptoms began 1 week AFTER vaccine. Reports all symptoms have resolved as of reporting to EOH. Of note, employee has not had a previous reaction to another vaccine, but did experience "severe reaction" when having TB skin test done.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Nausea, Pyrexia
Clinical narrative: Headache, Fever, Diarrhea, NauseaVomiting, injection site redness/swelling/pain/itching, fatigue Narrative:  Employee reports injection site redness/swelling/pain/itching, fatigue, headaches, chills (x 1 night, 1 week after vaccine), fatigue, and "some" nausea/vomiting/diarrhea. Notes itching was "intense." Also notes more local symptoms began 1 week AFTER vaccine. Reports all symptoms have resolved as of reporting to EOH. Of note, employee has not had a previous reaction to another vaccine, but did experience "severe reaction" when having TB skin test done.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Headache, Fever, Diarrhea, NauseaVomiting, injection site redness/swelling/pain/itching, fatigue Narrative:  Employee reports injection site redness/swelling/pain/itching, fatigue, headaches, chills (x 1 night, 1 week after vaccine), fatigue, and "some" nausea/vomiting/diarrhea. Notes itching was "intense." Also notes more local symptoms began 1 week AFTER vaccine. Reports all symptoms have resolved as of reporting to EOH. Of note, employee has not had a previous reaction to another vaccine, but did experience "severe reaction" when having TB skin test done.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Computerised tomogram thorax, Fatigue, Hypersomnia, Laboratory test
Clinical narrative: Patient states that on 1/8 he had low grade fever (99.8) and fatigue and he slept all day On 1/9/22 he woke up with a "baseball" sized swelling in his (L) armpit. He went to ER @ MC and was diagnosed with a superficial blood clot. Restarted on Eliquis. Inst'd to apply warm compresses up to 4x/day. States that swelling is "about the same" this morning.
Age: 53.0
Sex: M
Vaccine: COVID19
Symptoms: Oedema peripheral, Thrombosis, Ultrasound scan
Clinical narrative: Patient states that on 1/8 he had low grade fever (99.8) and fatigue and he slept all day On 1/9/22 he woke up with a "baseball" sized swelling in his (L) armpit. He went to ER @ MC and was diagnosed with a superficial blood clot. Restarted on Eliquis. Inst'd to apply warm compresses up to 4x/day. States that swelling is "about the same" this morning.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Cold sweat, Cyanosis, Nausea, Pallor, Pulse abnormal
Clinical narrative: During the prescribed waiting period the patient c/o nausea to his wife who is a Registered Nurse. She summoned staff who went to car to assess him. Pt was pale, skin cold "clammy and lips bluish. Patient was reclined in front seat of car. BP was 100/? Radial pulse not palpable. 0.1 mg Epinephrine IM in LD per RN @ 1355. EMS summoned per wife. Approximately 1357 BP 70/50, radial pulse faint & thready. EMS arrived & VS taken. O2 100% BP 108/70 Pt states he "feels a lot better" Pt transported to Medical Center per EMS.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Radial pulse abnormal
Clinical narrative: During the prescribed waiting period the patient c/o nausea to his wife who is a Registered Nurse. She summoned staff who went to car to assess him. Pt was pale, skin cold "clammy and lips bluish. Patient was reclined in front seat of car. BP was 100/? Radial pulse not palpable. 0.1 mg Epinephrine IM in LD per RN @ 1355. EMS summoned per wife. Approximately 1357 BP 70/50, radial pulse faint & thready. EMS arrived & VS taken. O2 100% BP 108/70 Pt states he "feels a lot better" Pt transported to Medical Center per EMS.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Headache, Injection site pain, Palpitations
Clinical narrative: Slight tenderness at injection site. Approximately 19 hours after booster, my hands, feet, and nose were cold and I could not warm then. Approximately 21.5 hours after booster, I went home and got into bed under several blankets. Two hours worth of shivering until I finally felt warm. One hour later, I needed to use the restroom and took my temperature. It was 102.5 but I attribute that number to being under several blankets. Took temperature one hour later just sitting in bed without all the blankets. Temperature was 101.9. Took 3 500 mg acetaminophen and temperature went down to 101.1 after approximately 20 minutes. Headache along frontal lobe Racing heart before standing, while standing going to restroom.
Age: 54.0
Sex: U
Vaccine: COVID19
Symptoms: Peripheral coldness
Clinical narrative: Slight tenderness at injection site. Approximately 19 hours after booster, my hands, feet, and nose were cold and I could not warm then. Approximately 21.5 hours after booster, I went home and got into bed under several blankets. Two hours worth of shivering until I finally felt warm. One hour later, I needed to use the restroom and took my temperature. It was 102.5 but I attribute that number to being under several blankets. Took temperature one hour later just sitting in bed without all the blankets. Temperature was 101.9. Took 3 500 mg acetaminophen and temperature went down to 101.1 after approximately 20 minutes. Headache along frontal lobe Racing heart before standing, while standing going to restroom.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: CSF culture, Computerised tomogram, Laboratory test, Magnetic resonance imaging, Myelitis transverse
Clinical narrative: Transverse Mylelitis Paralyzed waist down both sides
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Paralysis, X-ray
Clinical narrative: Transverse Mylelitis Paralyzed waist down both sides
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ectopic pregnancy, Exposure during pregnancy, Fallopian tube operation, Surgery, Uterine dilation and curettage
Clinical narrative: On October 1, 2021, I learned I had an ectopic pregnancy. I was 6 weeks pregnant. The CDC V- check system stopped checking on me after I reported being pregnant. It did not follow up to ensure I had a healthy pregnancy. I had no previous history of being at risk. I had a healthy pregnancy and delivered a healthy baby boy without pain medication in 2020, before getting the vaccine. I question if there is enough data around pregnant women and vaccinations since I received no follow up, and for a very healthy person with no prior history or risk factors, this was definitely an anomaly. The only difference from my first healthy delivery to my 2nd unsuccessful pregnancy was the vaccine.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Death, Full blood count abnormal, Neutropenic sepsis, Pulmonary embolism, Vena cava filter insertion
Clinical narrative: Unknown lot of vaccine and vaccination site - retrospective review/reporting. The patient experienced pulmonary embolism that was discovered when he was admitted for neutropenic sepsis. The patient was suffering from metastatic lung cancer. This shot was a booster dose. He had a family history of clots as well as a personal history following hip surgery. I felt the clots were more likely due to his malignancy, but I am reporting them for completeness. His blood counts did not allow the use of anticoagulation, and he has an IVC filter placed. That patient was discharged, and about a month later was readmitted and eventually passed away.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Product storage error
Clinical narrative: Booster dose: questioning lack of efficacy; Booster dose; Booster dose: administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 days; Booster dose: administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 days; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Dec2021 11:05 (Lot number: FH8030, Expiration Date: 28Feb2022) at the age of 66 years as dose number unknown (booster), 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLUZONE HIGH DOSE taken for immunisation; FLU taken for immunisation, administration date 15Dec2021. Vaccination history included: Covid-19 vaccine (1st dose, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (2nd dose, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28Dec2021 10:00, outcome "unknown", described as "Booster dose: questioning lack of efficacy"; IMMUNISATION (medically significant) with onset 22Dec2021 11:05, outcome "unknown", described as "Booster dose"; PRODUCT TEMPERATURE EXCURSION ISSUE (medically significant) with onset Dec2021, outcome "unknown", POOR QUALITY PRODUCT ADMINISTERED (medically significant) with onset 22Dec2021 11:05, outcome "unknown" and all described as "Booster dose: administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 days".  Additional information: It was reported that the vaccine was put it in freezer and it was kept between 25 degrees below Celsius and -15 degrees Celsius. Stated that it was at the normal temperature up to two weeks and was extended to 17 days. No treatment was taken for the events. History of all previous immunization with the Pfizer vaccine was none. Additional vaccines administered on same date of the pfizer suspect was none. There were no predisposing factors and a culture was not performed.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. 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.,Linked Report(s) : US-PFIZER INC-202200010841 same reporter/drug/event, different patient
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Immunisation, Poor quality product administered, Product temperature excursion issue
Clinical narrative: Booster dose: questioning lack of efficacy; Booster dose; Booster dose: administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 days; Booster dose: administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 days; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 66 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Dec2021 11:05 (Lot number: FH8030, Expiration Date: 28Feb2022) at the age of 66 years as dose number unknown (booster), 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLUZONE HIGH DOSE taken for immunisation; FLU taken for immunisation, administration date 15Dec2021. Vaccination history included: Covid-19 vaccine (1st dose, Manufacturer Unknown), for COVID-19 immunization; Covid-19 vaccine (2nd dose, Manufacturer Unknown), for COVID-19 immunization. The following information was reported: DRUG INEFFECTIVE (medically significant) with onset 28Dec2021 10:00, outcome "unknown", described as "Booster dose: questioning lack of efficacy"; IMMUNISATION (medically significant) with onset 22Dec2021 11:05, outcome "unknown", described as "Booster dose"; PRODUCT TEMPERATURE EXCURSION ISSUE (medically significant) with onset Dec2021, outcome "unknown", POOR QUALITY PRODUCT ADMINISTERED (medically significant) with onset 22Dec2021 11:05, outcome "unknown" and all described as "Booster dose: administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 days".  Additional information: It was reported that the vaccine was put it in freezer and it was kept between 25 degrees below Celsius and -15 degrees Celsius. Stated that it was at the normal temperature up to two weeks and was extended to 17 days. No treatment was taken for the events. History of all previous immunization with the Pfizer vaccine was none. Additional vaccines administered on same date of the pfizer suspect was none. There were no predisposing factors and a culture was not performed.; Sender's Comments: Based on the information in the case, a contributory effect of the vaccine BNT162B2 to the reported events cannot be ruled out. 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.,Linked Report(s) : US-PFIZER INC-202200010841 same reporter/drug/event, different patient
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 day; administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 day; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 67 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 22Dec2021 11:29 (Lot number: FH8030, Expiration Date: 28Feb2022) at the age of 67 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. Concomitant medication(s) included: INFLUENZA, administration date 10Dec2021.  The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 22Dec2021 11:29, outcome "unknown", PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 2021, outcome "unknown" and all described as "administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 day". Therapeutic measures were not taken as a result of poor quality product administered.  Additional information: NDC number of Pfizer Adult purple top vial was 59267100003 and NDC number of Influenza shot was 4928112188. Reporter clarified that the vaccine came from district health and they put it in their freezer and it is kept between 25 degrees below Celsius and and -15 degrees Celsius. Stated that it was at the normal temperature up to two weeks and was extended to 17 days per Pfizer from the other phone call. Count for which of the 8 patients received the Pfizer purple top vial pediatric dose not provided. NDC, lot number and expiration date were for both the adult and pediatric doses.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200010841 as same reporter/drug/event, different patient.
Age: 67.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 day; administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 day; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A 67 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 22Dec2021 11:29 (Lot number: FH8030, Expiration Date: 28Feb2022) at the age of 67 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. Concomitant medication(s) included: INFLUENZA, administration date 10Dec2021.  The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious) with onset 22Dec2021 11:29, outcome "unknown", PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious) with onset 2021, outcome "unknown" and all described as "administered vaccine that was supposed to be in the freezer for 14 days and was in 21 days past the 14 day". Therapeutic measures were not taken as a result of poor quality product administered.  Additional information: NDC number of Pfizer Adult purple top vial was 59267100003 and NDC number of Influenza shot was 4928112188. Reporter clarified that the vaccine came from district health and they put it in their freezer and it is kept between 25 degrees below Celsius and and -15 degrees Celsius. Stated that it was at the normal temperature up to two weeks and was extended to 17 days per Pfizer from the other phone call. Count for which of the 8 patients received the Pfizer purple top vial pediatric dose not provided. NDC, lot number and expiration date were for both the adult and pediatric doses.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200010841 as same reporter/drug/event, different patient.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Immunisation, SARS-CoV-2 test, Vaccination failure
Clinical narrative: cough; congestion; brain fog; exhaustion; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administration date 15Dec2021 13:00 (Lot number: FE3594) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 2, Prev dose brand: Pfizer, Lot no= EP6955), administration date: 26Mar2021, when the patient was 30 years old, for COVID-19 immunization; Bnt162b2 (Dose: 1, Prev dose brand: Pfizer, Lot no= EL3248), administration date: 05Mar2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 13:00, outcome "unknown", described as "booster"; COUGH (non-serious) with onset 29Dec2021, outcome "recovered", described as "cough"; NASAL CONGESTION (non-serious) with onset 29Dec2021, outcome "recovered", described as "congestion"; FEELING ABNORMAL (non-serious) with onset 29Dec2021, outcome "recovered", described as "brain fog"; FATIGUE (non-serious) with onset 29Dec2021, outcome "recovered", described as "exhaustion". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of cough, nasal congestion, feeling abnormal, fatigue.  Additional Information: The patient did not have other vaccine in four weeks. The patient had symptoms of cough, congestion, brain fog, and general exhaustion for a period of about 7 - 10 days. The patient did not have covid prior to vaccination. The patient had covid tested post vaccination. The patient do not have known allergies.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Fatigue, Feeling abnormal, Immunisation, Nasal congestion
Clinical narrative: cough; congestion; brain fog; exhaustion; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administration date 15Dec2021 13:00 (Lot number: FE3594) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 2, Prev dose brand: Pfizer, Lot no= EP6955), administration date: 26Mar2021, when the patient was 30 years old, for COVID-19 immunization; Bnt162b2 (Dose: 1, Prev dose brand: Pfizer, Lot no= EL3248), administration date: 05Mar2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 13:00, outcome "unknown", described as "booster"; COUGH (non-serious) with onset 29Dec2021, outcome "recovered", described as "cough"; NASAL CONGESTION (non-serious) with onset 29Dec2021, outcome "recovered", described as "congestion"; FEELING ABNORMAL (non-serious) with onset 29Dec2021, outcome "recovered", described as "brain fog"; FATIGUE (non-serious) with onset 29Dec2021, outcome "recovered", described as "exhaustion". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of cough, nasal congestion, feeling abnormal, fatigue.  Additional Information: The patient did not have other vaccine in four weeks. The patient had symptoms of cough, congestion, brain fog, and general exhaustion for a period of about 7 - 10 days. The patient did not have covid prior to vaccination. The patient had covid tested post vaccination. The patient do not have known allergies.
Age: 31.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: cough; congestion; brain fog; exhaustion; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received BNT162b2 (BNT162B2), administration date 15Dec2021 13:00 (Lot number: FE3594) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 2, Prev dose brand: Pfizer, Lot no= EP6955), administration date: 26Mar2021, when the patient was 30 years old, for COVID-19 immunization; Bnt162b2 (Dose: 1, Prev dose brand: Pfizer, Lot no= EL3248), administration date: 05Mar2021, when the patient was 30 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 15Dec2021 13:00, outcome "unknown", described as "booster"; COUGH (non-serious) with onset 29Dec2021, outcome "recovered", described as "cough"; NASAL CONGESTION (non-serious) with onset 29Dec2021, outcome "recovered", described as "congestion"; FEELING ABNORMAL (non-serious) with onset 29Dec2021, outcome "recovered", described as "brain fog"; FATIGUE (non-serious) with onset 29Dec2021, outcome "recovered", described as "exhaustion". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of cough, nasal congestion, feeling abnormal, fatigue.  Additional Information: The patient did not have other vaccine in four weeks. The patient had symptoms of cough, congestion, brain fog, and general exhaustion for a period of about 7 - 10 days. The patient did not have covid prior to vaccination. The patient had covid tested post vaccination. The patient do not have known allergies.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: The patient reported that his left arm has been sore every since he received his booster.  He states it is in the muscle where he received the vaccine and feels like he has over exerted his arm.  The pain is so bad that he has been taking 2 aleve per day to help the pain.
Age: 48.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Myalgia, Pain in extremity
Clinical narrative: The patient reported that his left arm has been sore every since he received his booster.  He states it is in the muscle where he received the vaccine and feels like he has over exerted his arm.  The pain is so bad that he has been taking 2 aleve per day to help the pain.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: No adverse event, Product storage error
Clinical narrative: ADMINISTRATION ERROR; This spontaneous report received from a physician concerned a 72 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, administered on 09-JAN-2022 14:45 for prophylactic vaccination. No concomitant medications were reported.  On 09-JAN-2022, the patient experienced administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration error was not reported. This report was non-serious.
Age: 72.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Poor quality product administered
Clinical narrative: ADMINISTRATION ERROR; This spontaneous report received from a physician concerned a 72 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 213D21A, expiry: 11-APR-2022) dose was not reported, administered on 09-JAN-2022 14:45 for prophylactic vaccination. No concomitant medications were reported.  On 09-JAN-2022, the patient experienced administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration error was not reported. This report was non-serious.
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Blood pressure increased, Blood test normal, Chest pain, Computerised tomogram normal
Clinical narrative: Chest pain, elevated blood pressure, fatigue/weakness, body aches, fever,
Age: 23.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Electrocardiogram normal, Fatigue, Pain, Pyrexia, X-ray normal
Clinical narrative: Chest pain, elevated blood pressure, fatigue/weakness, body aches, fever,
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Ear pain, Headache, Hyperacusis
Clinical narrative: Rash around site and blotchiness, body aches, severe nerve pain, ongoing headache, ear aches, sensitivity to sound, high blood pressure, nausea, diarrhea, dizziness.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Hypertension, Injection site rash, Nausea, Neuralgia, Pain
Clinical narrative: Rash around site and blotchiness, body aches, severe nerve pain, ongoing headache, ear aches, sensitivity to sound, high blood pressure, nausea, diarrhea, dizziness.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Rash macular
Clinical narrative: Rash around site and blotchiness, body aches, severe nerve pain, ongoing headache, ear aches, sensitivity to sound, high blood pressure, nausea, diarrhea, dizziness.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test
Clinical narrative: Soar throat with pain, chills, fever, cough
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Spontaneous Urticaria on the face began night after vaccine, just over the 24 hr mark. It has occurred every evening since the first night.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Headache, Heart rate increased, Injection site pain, Lymphadenopathy
Clinical narrative: Immediate pain at injection site. Headache. Muscle soreness in arm. Lump formed in armpit - significant lymph gland swelling in arm of injection. Pain in left breast. Next Period 7 days late. Abnormally long menstrual cycle. Increased heart rate while in bed during the days following the booster.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Oligomenorrhoea
Clinical narrative: Immediate pain at injection site. Headache. Muscle soreness in arm. Lump formed in armpit - significant lymph gland swelling in arm of injection. Pain in left breast. Next Period 7 days late. Abnormally long menstrual cycle. Increased heart rate while in bed during the days following the booster.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Dermatologic examination, Rash, Urticaria
Clinical narrative: One day after receiving my covid booster I broke into hives on my elbows, knees, and lower butt area. I visited a dermatologist the next day and was prescribed Atarax and a steroid cream. The hives will move to different parts of my body throughout the day but stay in these general areas. I have never had hives or a rash like this prior.  I am still dealing with this after 6 days.
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Blood test abnormal, Cardiomegaly, Chest pain, Electrocardiogram abnormal
Clinical narrative: Hives all over body that come and go and appear in different areas, chest pain all the time that mimics heart attack symptoms, stomach pain
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Myocardial infarction, Urticaria, White blood cell count increased
Clinical narrative: Hives all over body that come and go and appear in different areas, chest pain all the time that mimics heart attack symptoms, stomach pain
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Nausea
Clinical narrative: Dizziness occurred 5-10 min after dose administration. Lasted about 30-45 min. Mild nausea occurred around the same time.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Erythema, Loss of personal independence in daily activities, Pruritus, Sleep disorder
Clinical narrative: Chronic hives all over body and daily burning/redness of ears. Both disappear and reappear throughout the day. Constant itching when anything touches my skin: water, my hair hanging on my shoulders, clothing, my blanket touching my skin at night. Every morning when I wash my face with plain water, my face turns bright red, swells up, and break out into hives. Also if I accidentally scratch myself, it causes hives to break out all over body.  The itching disrupts my sleep and daily life.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Urticaria
Clinical narrative: Chronic hives all over body and daily burning/redness of ears. Both disappear and reappear throughout the day. Constant itching when anything touches my skin: water, my hair hanging on my shoulders, clothing, my blanket touching my skin at night. Every morning when I wash my face with plain water, my face turns bright red, swells up, and break out into hives. Also if I accidentally scratch myself, it causes hives to break out all over body.  The itching disrupts my sleep and daily life.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Eye pain, Glossodynia, Headache, Pain, Pain in extremity
Clinical narrative: 1. Huge swelling and pain under arm of injection, started about 12 hours after vaccination 2. Swelling and pain under tongue on left side, started about 24 hours after vaccination 3. Throbbing pain in left eye, started about 12 hours after vaccination 4. Headache, started about 6 hours after vaccination 5. Body aches, started after about 4 hours after vaccination
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Swollen tongue
Clinical narrative: 1. Huge swelling and pain under arm of injection, started about 12 hours after vaccination 2. Swelling and pain under tongue on left side, started about 24 hours after vaccination 3. Throbbing pain in left eye, started about 12 hours after vaccination 4. Headache, started about 6 hours after vaccination 5. Body aches, started after about 4 hours after vaccination
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Anti-GAD antibody, Anti-islet cell antibody positive, Blood glucose, Glycosylated haemoglobin, Insulin C-peptide decreased
Clinical narrative: After taking both series of vaccines of Moderna and Booster I developed Type 1 diabetes due to a decrease of vitamin D and C-Peptide, an increase of GAD-65A, and a positive Islet Cell Antibody Screen test.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Type 1 diabetes mellitus, Vitamin D decreased
Clinical narrative: After taking both series of vaccines of Moderna and Booster I developed Type 1 diabetes due to a decrease of vitamin D and C-Peptide, an increase of GAD-65A, and a positive Islet Cell Antibody Screen test.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Urticaria, Urticaria chronic
Clinical narrative: 8 days after booster experienced severe hives and itching in patches all over body that would come and go. Back of the head and neck, groin, back, arms, and hips were all particularly bad. Overall worse in the evening and if something rough was rubbing/touching that area. Chronic urticaria and pruritus ever since. Mild most of the time with some bad flare-ups every few days.
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Heart rate increased, Neck pain, Pain in extremity
Clinical narrative: PATIENT AND MPOTHER CAME TOGETHER TO GET COVID BOOSTER SHOTS  . THERE WAS ONLY 1 DOSE OF EACH MODERNA 0.25ML BOOSTER AND PFIZER 0.3ML BOOSTER LEFT WHEN THEY CAME TO PHARMACY CLINIC AT END OF DAY.  DOSES GOT SWITCHED AND 14 YEAR OLD GOT MODERNA BOOSTER AND MOM GOT PFIZER BOOSTER. BY  CLINIC NURSE GIVING  SHOTS ERROR DISCOVERED BY PHARMACY WHEN PAPERWORK WAS BEING PROCESS THE FOLLOWING WEEK.1/14/22  MOM WAS CONTACTED STATES CHILD HAD SORE ARM , FATIGUE, SLIGHT HEADACHE , FEVER AND EVEVATED HEART RATE, A FEW DAYS  AFTER BOOSTER, BUT  NOW JUST A LITTLE ARM /NECK SORENESS .DOING FINE. PER MOTHER
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: PATIENT AND MPOTHER CAME TOGETHER TO GET COVID BOOSTER SHOTS  . THERE WAS ONLY 1 DOSE OF EACH MODERNA 0.25ML BOOSTER AND PFIZER 0.3ML BOOSTER LEFT WHEN THEY CAME TO PHARMACY CLINIC AT END OF DAY.  DOSES GOT SWITCHED AND 14 YEAR OLD GOT MODERNA BOOSTER AND MOM GOT PFIZER BOOSTER. BY  CLINIC NURSE GIVING  SHOTS ERROR DISCOVERED BY PHARMACY WHEN PAPERWORK WAS BEING PROCESS THE FOLLOWING WEEK.1/14/22  MOM WAS CONTACTED STATES CHILD HAD SORE ARM , FATIGUE, SLIGHT HEADACHE , FEVER AND EVEVATED HEART RATE, A FEW DAYS  AFTER BOOSTER, BUT  NOW JUST A LITTLE ARM /NECK SORENESS .DOING FINE. PER MOTHER
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Chest discomfort, Chest pain, Computerised tomogram thorax, Electrocardiogram
Clinical narrative: I developed severe chest pain radiating to my left arm and back, palpitations, and easy fatiguability which lasted for days/weeks. EKG, CT scan and laboratory tests  were done but they were unremarkable. Prednisone was prescribed for 5 days but even after the medication course was completed, the chest discomfort and palpitations were still present. On my follow-up appointment with a FNP,  diclofenac PO was prescribed.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Palpitations, Troponin I
Clinical narrative: I developed severe chest pain radiating to my left arm and back, palpitations, and easy fatiguability which lasted for days/weeks. EKG, CT scan and laboratory tests  were done but they were unremarkable. Prednisone was prescribed for 5 days but even after the medication course was completed, the chest discomfort and palpitations were still present. On my follow-up appointment with a FNP,  diclofenac PO was prescribed.
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches nearly every day since receiving Pfizer Covid-19 Booster.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Endotracheal intubation, Hepatic pain, Low lung compliance, Mechanical ventilation, Respiratory tract infection
Clinical narrative: I WAS GIVEN  Remdesivir BY IV THERAPY. IT GAVE ME SEVERE PAIN IN AND AROUND THE AREA OF MY LIVER. IT HAS CAUSED MY LUNGS TO TEND TO FEEL STIFFER AND I GET RESPIRATORY INFECTIONS EASIER.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Dizziness, Nausea, Vertigo, Vomiting
Clinical narrative: This spontaneous report was received from a 65-year-old male patient, who was referring to himself (directly and also via Pfizer). The patient's medical history included two doses of elasomeran (COVID-19 VACCINE MODERNA) and one dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23). His concomitant therapies included unspecified cholesterol medication and a booster dose of tonzinameran (PFIZER BIONTECH COVID-19 VACCINE). He did not have any known drug reactions or allergies. On 28-DEC-2021, around 8:15 a.m., the patient was administered a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) in his right arm (formulation, dose, lot #, expiry date, and route of administration were not provided) for prophylaxis (reported as "immunizations" and "routine vaccination and age"). On 29-DEC-2021, around 3 a.m., the patient woke up feeling dizzy along with nausea and vomiting symptoms. Everything was spinning around and he felt like he could vomit but could not. On 30-DEC-2021, around 4 a.m., the events came back. The patient reported that it was ok when he was up, but when he laid down, it (dizziness) came back and that he thought that he had a side effect. The patient did not seek medical attention, no relevant laboratory diagnostics or studies were performed and no treatment was given for the events. At the time of reporting, the patient had not recovered from the events(discrepant information, also reported as recovering/resolving). The causal relationship between feeling dizzy, nausea and vomiting symptoms and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not reported.
Age: 28.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: no reported side effects; the syringe attached to the pre-filled syringe and stored in the refrigerator for 4 days. Per caller, the syringe was attached to give to a patient and the patient decided not to get it so it was placed back in the refrigerator and was accidentally u; Information has been received from a nurse, referring to a 28 year-old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  The reporting nurse stated that on 21-DEC-2021, 1 dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot number reported as "T0136442" (administration route and anatomical location were not reported) was administered to a patient after it had the syringe attached to the pre-filled syringe and stored in the refrigerator for 4 days. It was reported that the syringe was attached to give to a patient and the patient decided not to get it so it was placed back in the refrigerator and was accidently used 4 days later on 25-DEC-2021. The reporting nurse stated they have checked on patient since receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine and patient had no reported side effects.  Lot number T0136442 is an invalid lot number for [hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). Lot number T0136442  does not match any Company product as confirmed by Lot Verification team.