chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Fall, Pallor, Syncope
Clinical narrative: THE PATIENT WAS SITTING IN A CHAIR AFTER THE SHOT AND SLUMPED OVER TO THE SIDE. SHE WAS PALE IN THE FACE. WE RAN OVER AND WERE ABLE TO WAKE HER UP. SHE BEGAN TALKING SOON AFTER. WE ASKED IF SHE HAD ANYTHING TO EAT THAT DAY AND SHE REPLIED NO. WE PROVIDED HER WITH COLD GATORADE TO DRINK WHILE WE SAT AND TALKED TO HER. AFTER 40 MINUTES OF SITTING AND TALKING SHE WAS ABLE TO STAND UP SAFELY AND LEAVE THE PHARMACY. THE REACTION WAS CONSIDERED TO BE A FAINTING SPELL WHILE SITTING IN A CHAIR AFTER THE SHOT
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: An incident occurred where a patient of 10 years old was given the Pfizer Bivalent booster approved for 12+. This occurred while the pharmacist was occupied with resolving a customer issue. The technicians were told prior to bring the forms to the pharmacist for final verification before allowing the student to administer the vaccine. However, the techs allowed the student to administer the shot before the pharmacist perform the final verification. The mother was notified of the incident after they had left the pharmacy when the incident was discovered during batching of the shots. The mother was told to watch out for any adverse effects and to notify their doctor if anything serious occurs. The mother thanked us for notifying  her of the incident.
Age: 12.0
Sex: F
Vaccine: COVID19-2
Symptoms: Balance disorder, Ear discomfort, Hypoacusis, Tinnitus
Clinical narrative: Tinnitus and ear fullness in the ear on the same side of the body as the covid vaccination was given. Hearing reduced. Balance issues.
Age: 2.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Injection site discomfort, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: My child was given DTaP and HIB conjugate both in his right thigh. I?m unsure of the brand of the vaccines. Doctor said it was typical of DTaP to cause a reaction like this. His thigh was swollen, red and hot and felt almost fluid filled like there was a lot of pressure under the skin. It was very inflamed and he was in pain for 3 days and it?s just now starting to shrink. Still warm.
Age: 2.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Injection site warmth
Clinical narrative: My child was given DTaP and HIB conjugate both in his right thigh. I?m unsure of the brand of the vaccines. Doctor said it was typical of DTaP to cause a reaction like this. His thigh was swollen, red and hot and felt almost fluid filled like there was a lot of pressure under the skin. It was very inflamed and he was in pain for 3 days and it?s just now starting to shrink. Still warm.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder
Clinical narrative: menstrual cycle was impacted following 1st (2/11/21) and 2nd (3/11/21) doses of the Moderna Covid-19 vaccine.  Specifically, I had not had a period since approximately May 2018 following IUD insertion for contraception.   Following the vaccination, I began having active periods again.  This change lasted from March 2021 until September 2022, at which time the periods have again stopped.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Asthenia, Diarrhoea, Dizziness, Dyspnoea, Fatigue
Clinical narrative: My 14 y/o daughter got the guardasil shot on 10/10/22 & later the same day began to have side affect that worsened by morning & by later that day Shortness of breath, headache , diarrhea, dizziness , vision burry, tired , weak .. body aches , hot , but cold ... said she spit blood also , that's all her symptoms. in the morning we are going to ER.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling of body temperature change, Haemoptysis, Headache, Pain, Vision blurred
Clinical narrative: My 14 y/o daughter got the guardasil shot on 10/10/22 & later the same day began to have side affect that worsened by morning & by later that day Shortness of breath, headache , diarrhea, dizziness , vision burry, tired , weak .. body aches , hot , but cold ... said she spit blood also , that's all her symptoms. in the morning we are going to ER.
Age: 60.0
Sex: F
Vaccine: MNQ
Symptoms: Dizziness postural, Furuncle, Headache, Injection site swelling, Skin warm
Clinical narrative: i received a vacination Menquadfi inj San NDC 49281-0590 before 24 hours were over the arm was swollen around the injection site it went beyond the injection site by 3-4 inches on each side. That area was hot to the touch and where the injection went in it looked a bit like a boil heading up. on Sunday morning about 48 hours after the injection I started to become dizzy after I bent down to put on my shoes or something like that and that continued with a strong headache until sometime one Monday. I called the pharmacist on monday and he thought that I was not in an emergency situation by wednesday things began to improve, but I still has a headache off and on for about two weeks and I still have trouble with dizziness when I change my position. like laying down or getting up after being in bed for some hours at night. I was just told that I should report this to you, I am not asking you to do anything but record it.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Depressed level of consciousness, Gait inability, Lethargy, Neurological symptom, Speech disorder
Clinical narrative: After receiving the second and third COVID boosters patient had stroke like symptoms, unable to talk, stay alert, walk. She is slowly coming out of the symptoms but remains very lethargic.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure decreased, Dizziness, Heart rate decreased
Clinical narrative: blood pressure which showed 90/50, pulse 50. His normal blood pressure oscillates in the range of 140-145/80-90 with a pulse of 80-90; pulse 50; dizzy; very weak; This is a spontaneous report from a contactable consumer. A 66-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, Solution for injection, Lot number: Unknown), via an unspecified route of administration on an unspecified date in Apr2021 at 17:00 (at the age of 66-year-old), as dose 1, single for COVID-19 immunization. The patient's medical history included ulcerative colitis, few years in remission from an unknown date and unknown if ongoing. Prior to vaccination, the patient was not diagnosed with COVID-19. Concomitant medications were not reported. It was unknown that if patient had received any other vaccines within 4 weeks. Since the vaccination, patient was not tested for COVID-19. It was reported that, the reporter's brother was in country. On an unspecified date in Apr2021, the next day morning after the administration of first dose of vaccine, while at work the patient felt dizzy and very weak. The patient sat in the car for about 3 hours after which he went back home. The patient checked his blood pressure which showed 90/50, pulse 50. His normal blood pressure oscillated in the range of 140-145/80-90 with a pulse of 80-90. The patient had lunch after which went to bed and slept for about 4 hours. After the patient got up, he felt fine, and his blood pressure went back up to his levels. The patient received his 2nd vaccine on 01Jun2021 and had no reaction whatsoever. Patient had not received treatment for adverse events. The patient underwent lab tests and procedures which included blood pressure measurement: 90/50 and later showed normal level; heart rate: normal, all performed on unspecified dates. The clinical outcome of all the events was resolved on an unspecified dates.  Information on the lot/batch number has been requested.  Follow-up (02Jul2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 65.0
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine exp: Use by date = 10/7/22 8 wk after defrost Exp. Date = 10/31/2024
Age: 30.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered, Syringe issue
Clinical narrative: Administration Error: Attempted to give vaccine via ID route on Left arm. Vaccine leaked immediately. No weal noted. Needle removed from arm. Dose wasted. Vaccine re-administered on Right arm with new vaccine/needle/syringe. Rationale explained to client.
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Febrile neutropenia, Intensive care, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Narrative: Fully vaccinated, COVID positive on admission to ICU for neutropenic fever. Patient treated for septic pneumonia and COVID
Age: 89.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: Narrative: Fully vaccinated, COVID positive on admission to ICU for neutropenic fever. Patient treated for septic pneumonia and COVID
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac stress test, Chest pain, Injection site pain, Myocarditis, Pain
Clinical narrative: Narrative:  Patient had Moderna COVID vaccine administered on 10/28/21. On 11/15/21 patient presented to office unscheduled reporting "intermittent left upper chest pain radiating into next, left shoulder, left arm" starting 3 days prior (11/12/21). Patient not interested in full work up and left office AMA when provider did not perform the requested test per clinical judgement. Patient scheduled for stress test which patient cancelled due to "upper respiratory infection", no documentation scanned in regarding infection. patient with a PMH of uncontrolled GERD. Patient eventually got stress test performed 2 months later which was negative. ADR added to patient's chart as "myocarditis" and "chest pain"
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Upper respiratory tract infection
Clinical narrative: Narrative:  Patient had Moderna COVID vaccine administered on 10/28/21. On 11/15/21 patient presented to office unscheduled reporting "intermittent left upper chest pain radiating into next, left shoulder, left arm" starting 3 days prior (11/12/21). Patient not interested in full work up and left office AMA when provider did not perform the requested test per clinical judgement. Patient scheduled for stress test which patient cancelled due to "upper respiratory infection", no documentation scanned in regarding infection. patient with a PMH of uncontrolled GERD. Patient eventually got stress test performed 2 months later which was negative. ADR added to patient's chart as "myocarditis" and "chest pain"
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, COVID-19, Confusional state, Lethargy, SARS-CoV-2 test positive
Clinical narrative: Narrative: Fully vaccinated, COVID positive on admission for weakness, lethargy, and confusion. Patient was treated for sepsis and COVID.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Sepsis
Clinical narrative: Narrative: Fully vaccinated, COVID positive on admission for weakness, lethargy, and confusion. Patient was treated for sepsis and COVID.
Age: 15.0
Sex: U
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: Dose of 0.2 ml given Instead of correct dose of 0.3 ml. DPH contacted.  needs re-vaccination. Nurse to call  mom, explain, & schedule dose. Pt is in no harm.
Age: 49.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Extra dose administered, Incorrect dose administered, Injection site discharge
Clinical narrative: Attempted to give Vaccine via ID route on Left arm.  Weal was developing and vaccine started to leak out.  Removed needle upon leak.  Revaccinated on Right arm with new dose/needle/syringe.  Rationale for revaccinating explained. Client reported that he also had a flu vaccine on 09/23/2022. Was not recorded in the Immunization Registry.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Pneumonia, Respiratory distress, SARS-CoV-2 test positive
Clinical narrative: Narrative: Fully vaccinated, COVID positive on admission for respiratory distress. Patient was treated for COVID and PNA.
Age: 12.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: Patient received Bivalent for her first dose of Covid instead of the primary series for ages 12+ up. Mom notified of immunization error. DPH notified. Patient has not had a reaction.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative: Fully vaccinated, COVID positive on admission for SI.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Diabetes mellitus, Hyperglycaemia, SARS-CoV-2 test positive
Clinical narrative: Narrative: Fully vaccinated, COVID positive on admission for hyperglycemia secondary to new onset of DM. Patient was asymptomatic.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Grunting, Tachycardia
Clinical narrative: Vaccines given 9-13-22. Same day of shots till noon the next day pt had tachycardia and grunting.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Condition aggravated, Migraine, Rash
Clinical narrative: Rash  migraine Narrative:  reassurance only
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, Hyperglycaemia, SARS-CoV-2 test positive
Clinical narrative: Narrative: Fully vaccinated, COVID positive on admission for hyperglycemia. Patient was asymptomatic.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Dyspnoea, Hypoxia, SARS-CoV-2 test positive
Clinical narrative: Narrative: Fully vaccinated, COVID positive on admission for dyspnea and hypoxia. Patient received COVID treatment and continued O2 supplementation.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Asymptomatic COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative: Fully vaccinated, COVID positive on preadmission for EVAR on 09/16/2022. Patient was asymptomatic.
Age: 90.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Fall, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Narrative: Fully vaccinated, COVID positive on admission after a fall while looking for new SNF placement. Patient developed a fever.
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cough, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Narrative: Fully vaccinated, COVID positive on admission for fever and cough.
Age: 71.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine: Use by date = 10/17/2022 8 wk after defrost Exp. date = 10/31/2024
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Encephalopathy
Clinical narrative: Narrative: Hospitalization: Fully vaccinated, admitted with encephalopathy and COVID infection
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Cardiac failure, Chronic obstructive pulmonary disease, Pneumonia, SARS-CoV-2 test positive
Clinical narrative: Narrative: Fully vaccinated, COVID positive on admission. Treated for HF,COPD exacerbation, and PNA
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative: Fully vaccinated, COVID positive on admission while awaiting SNF placement.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: Narrative: Hospitalization, Fully vaccinated, COVID positive (h/o asthma with ongoing cough)
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Narrative:  At appointment for second shingrix dose, patient stated that he experienced arm and feet/ankle pains and swelling that took three days for the swelling to come down and a month to get back to his walking routine.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pneumonia
Clinical narrative: Narrative: Hospitalization, treated for CAP
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash papular, Skin warm
Clinical narrative: SkinRash, Rash, rash - minimally raised, warm to the touch Narrative:
Age: 26.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Hyperhidrosis, Thirst, Tinnitus, Vision blurred
Clinical narrative: BlurredVision diaphoresis, thirsty, tinnitus  Narrative: Reaction occurred within 5 minutes post vaccination and employee was taken to the ED, later discharged to home.
Age: 62.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine exp. use by date 10/7/22 8 weeks and defrost exp. date: 10/31/2024
Age: 45.0
Sex: U
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine exp: use by date 10/7/22 8 weeks & defrost exp. date: 10/31/2024
Age: 44.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine exp. use by date = 10/7/22 8weeks follow defrost VS. Exp. date 10/31/2024
Age: 57.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine exp. use by date = 10/7/22 8 weeks after defrost exp. date = 10/31/2024
Age: 33.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine exp: use by date 10/7/2022 8 wk after defrost Exp Date 10/31/2024
Age: 39.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine exp. use by date = 10/7/22 8 weeks follow defrost VS Exp. date 10/31/2024
Age: 63.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine exp: use by date = 10/7/22 8 wk after defrost Exp Dae 10/31/2024
Age: 26.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine exp Use by date = 10/7/2022(8wks after defrost) Exp. Date = 10/31/2024
Age: 56.0
Sex: M
Vaccine: SMALLMNK
Symptoms: Expired product administered
Clinical narrative: Vaccine exp. 10/7/2022 -(use by date) 8 weeks following - defrost VS Exp. date 10/31/2024
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test positive
Clinical narrative: He and his wife took the Pfizer vaccine, they got the Covid virus; He and his wife took the Pfizer vaccine, they got the Covid virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6207) and as dose 2, single (Lot number: ER8734) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He and his wife took the Pfizer vaccine, they got the covid virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid is only 3 Percent effective in helping with the covid virus and after he met with the cardiologist, they were going to put him and his wife in the hospital and give them and Pfizer made the vaccine, made Paxlovid and may make too and not one of those products work. Description of Product Complaint . It was reported the vaccine product had a bad batch of vaccine and he does not know if he and his wife got that bad batch or not.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201225721 similar report from same reporter.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Arterial tortuosity syndrome, Arthralgia, Arthropod bite, Atrial fibrillation, Blood pressure measurement
Clinical narrative: He and his wife took the Pfizer vaccine, they got the Covid virus; He and his wife took the Pfizer vaccine, they got the Covid virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6207) and as dose 2, single (Lot number: ER8734) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He and his wife took the Pfizer vaccine, they got the covid virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid is only 3 Percent effective in helping with the covid virus and after he met with the cardiologist, they were going to put him and his wife in the hospital and give them and Pfizer made the vaccine, made Paxlovid and may make too and not one of those products work. Description of Product Complaint . It was reported the vaccine product had a bad batch of vaccine and he does not know if he and his wife got that bad batch or not.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201225721 similar report from same reporter.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood pressure systolic, Blood test, C-reactive protein, Cardiac disorder, Cardiomyopathy
Clinical narrative: He and his wife took the Pfizer vaccine, they got the Covid virus; He and his wife took the Pfizer vaccine, they got the Covid virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6207) and as dose 2, single (Lot number: ER8734) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He and his wife took the Pfizer vaccine, they got the covid virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid is only 3 Percent effective in helping with the covid virus and after he met with the cardiologist, they were going to put him and his wife in the hospital and give them and Pfizer made the vaccine, made Paxlovid and may make too and not one of those products work. Description of Product Complaint . It was reported the vaccine product had a bad batch of vaccine and he does not know if he and his wife got that bad batch or not.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201225721 similar report from same reporter.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Carotid arteriosclerosis, Cellulitis, Cerebrovascular accident, Chest X-ray, Chest pain
Clinical narrative: He and his wife took the Pfizer vaccine, they got the Covid virus; He and his wife took the Pfizer vaccine, they got the Covid virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6207) and as dose 2, single (Lot number: ER8734) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He and his wife took the Pfizer vaccine, they got the covid virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid is only 3 Percent effective in helping with the covid virus and after he met with the cardiologist, they were going to put him and his wife in the hospital and give them and Pfizer made the vaccine, made Paxlovid and may make too and not one of those products work. Description of Product Complaint . It was reported the vaccine product had a bad batch of vaccine and he does not know if he and his wife got that bad batch or not.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201225721 similar report from same reporter.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Dizziness, Dysstasia, Electrocardiogram, Erythema, Fatigue
Clinical narrative: He and his wife took the Pfizer vaccine, they got the Covid virus; He and his wife took the Pfizer vaccine, they got the Covid virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6207) and as dose 2, single (Lot number: ER8734) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He and his wife took the Pfizer vaccine, they got the covid virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid is only 3 Percent effective in helping with the covid virus and after he met with the cardiologist, they were going to put him and his wife in the hospital and give them and Pfizer made the vaccine, made Paxlovid and may make too and not one of those products work. Description of Product Complaint . It was reported the vaccine product had a bad batch of vaccine and he does not know if he and his wife got that bad batch or not.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201225721 similar report from same reporter.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Fear of death, Full blood count, Gait disturbance, Haemorrhage, Hypertension
Clinical narrative: He and his wife took the Pfizer vaccine, they got the Covid virus; He and his wife took the Pfizer vaccine, they got the Covid virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6207) and as dose 2, single (Lot number: ER8734) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He and his wife took the Pfizer vaccine, they got the covid virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid is only 3 Percent effective in helping with the covid virus and after he met with the cardiologist, they were going to put him and his wife in the hospital and give them and Pfizer made the vaccine, made Paxlovid and may make too and not one of those products work. Description of Product Complaint . It was reported the vaccine product had a bad batch of vaccine and he does not know if he and his wife got that bad batch or not.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201225721 similar report from same reporter.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Impaired driving ability, Impaired quality of life, Mobility decreased, Muscle rupture, Myocardial infarction
Clinical narrative: He and his wife took the Pfizer vaccine, they got the Covid virus; He and his wife took the Pfizer vaccine, they got the Covid virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6207) and as dose 2, single (Lot number: ER8734) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He and his wife took the Pfizer vaccine, they got the covid virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid is only 3 Percent effective in helping with the covid virus and after he met with the cardiologist, they were going to put him and his wife in the hospital and give them and Pfizer made the vaccine, made Paxlovid and may make too and not one of those products work. Description of Product Complaint . It was reported the vaccine product had a bad batch of vaccine and he does not know if he and his wife got that bad batch or not.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201225721 similar report from same reporter.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Orthostatic hypotension, Pain, Pain in extremity, Peripheral swelling, Poor quality product administered
Clinical narrative: He and his wife took the Pfizer vaccine, they got the Covid virus; He and his wife took the Pfizer vaccine, they got the Covid virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6207) and as dose 2, single (Lot number: ER8734) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He and his wife took the Pfizer vaccine, they got the covid virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid is only 3 Percent effective in helping with the covid virus and after he met with the cardiologist, they were going to put him and his wife in the hospital and give them and Pfizer made the vaccine, made Paxlovid and may make too and not one of those products work. Description of Product Complaint . It was reported the vaccine product had a bad batch of vaccine and he does not know if he and his wife got that bad batch or not.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201225721 similar report from same reporter.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pulmonary thrombosis, Rash, Red blood cell sedimentation rate, Renal ischaemia, Scan brain
Clinical narrative: He and his wife took the Pfizer vaccine, they got the Covid virus; He and his wife took the Pfizer vaccine, they got the Covid virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6207) and as dose 2, single (Lot number: ER8734) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He and his wife took the Pfizer vaccine, they got the covid virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid is only 3 Percent effective in helping with the covid virus and after he met with the cardiologist, they were going to put him and his wife in the hospital and give them and Pfizer made the vaccine, made Paxlovid and may make too and not one of those products work. Description of Product Complaint . It was reported the vaccine product had a bad batch of vaccine and he does not know if he and his wife got that bad batch or not.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201225721 similar report from same reporter.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Skin lesion, Tachycardia, Thrombosis, Troponin, Ultrasound Doppler
Clinical narrative: He and his wife took the Pfizer vaccine, they got the Covid virus; He and his wife took the Pfizer vaccine, they got the Covid virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6207) and as dose 2, single (Lot number: ER8734) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He and his wife took the Pfizer vaccine, they got the covid virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid is only 3 Percent effective in helping with the covid virus and after he met with the cardiologist, they were going to put him and his wife in the hospital and give them and Pfizer made the vaccine, made Paxlovid and may make too and not one of those products work. Description of Product Complaint . It was reported the vaccine product had a bad batch of vaccine and he does not know if he and his wife got that bad batch or not.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201225721 similar report from same reporter.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Ultrasound scan, Vertigo, Wound secretion, X-ray
Clinical narrative: He and his wife took the Pfizer vaccine, they got the Covid virus; He and his wife took the Pfizer vaccine, they got the Covid virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6207) and as dose 2, single (Lot number: ER8734) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He and his wife took the Pfizer vaccine, they got the covid virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid is only 3 Percent effective in helping with the covid virus and after he met with the cardiologist, they were going to put him and his wife in the hospital and give them and Pfizer made the vaccine, made Paxlovid and may make too and not one of those products work. Description of Product Complaint . It was reported the vaccine product had a bad batch of vaccine and he does not know if he and his wife got that bad batch or not.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201225721 similar report from same reporter.
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: He and his wife took the Pfizer vaccine, they got the Covid virus; He and his wife took the Pfizer vaccine, they got the Covid virus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EN6207) and as dose 2, single (Lot number: ER8734) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "He and his wife took the Pfizer vaccine, they got the covid virus". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Paxlovid is only 3 Percent effective in helping with the covid virus and after he met with the cardiologist, they were going to put him and his wife in the hospital and give them and Pfizer made the vaccine, made Paxlovid and may make too and not one of those products work. Description of Product Complaint . It was reported the vaccine product had a bad batch of vaccine and he does not know if he and his wife got that bad batch or not.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201225721 similar report from same reporter.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Immunoglobulin therapy, Muscular weakness
Clinical narrative: came down with GBS in Apr after my 2nd covid booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 3 (1st booster), manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant) with onset Apr2022, outcome "unknown", described as "came down with GBS in Apr after my 2nd covid booster".  Clinical course: Description of Inquiry: Patient came down with GBS in April after 2nd covid booster.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Guillain-Barre syndrome
Clinical narrative: came down with GBS in Apr after my 2nd covid booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 3 (1st booster), manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 1, manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2, manufacturer unknown), for COVID-19 immunization. The following information was reported: GUILLAIN-BARRE SYNDROME (medically significant) with onset Apr2022, outcome "unknown", described as "came down with GBS in Apr after my 2nd covid booster".  Clinical course: Description of Inquiry: Patient came down with GBS in April after 2nd covid booster.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: U
Vaccine: DTPPVHBHPB, PNC13, RV5, RV5
Symptoms: Expired product administered
Clinical narrative: Caller is a nurse reporting that an expired dose of ROTATEQ was administered to the patient on 15SEP2022. Caller confirmed that the ROTATEQ has not been involved in a temperautre excursion through the date of administration. No additional information; No additional AE; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-SEP-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot #1741381, expiration date: 04-SEP-2022, administered orally for prophylaxis (strength was not provided). The reporting nurse stated that the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) has not been involved in a temperature excursion through the date of administration. No additional adverse events were reported.
Sex: U
Vaccine: DTPPVHBHPB, PNC13, RV5, RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: Caller is a nurse reporting that an expired dose of ROTATEQ was administered to the patient on 15SEP2022. Caller confirmed that the ROTATEQ has not been involved in a temperautre excursion through the date of administration. No additional information; No additional AE; Information has been received from a nurse, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 15-SEP-2022, the patient was vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 ml, lot #1741381, expiration date: 04-SEP-2022, administered orally for prophylaxis (strength was not provided). The reporting nurse stated that the rotavirus vaccine, live, oral, pentavalent (ROTATEQ) has not been involved in a temperature excursion through the date of administration. No additional adverse events were reported.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lymphadenopathy, Paraesthesia
Clinical narrative: had left back pain; had left shoulder pain; pain radiated down left arm; hard lump on side of chest between armpit and breast; ingrown hair; tingling in fingers and palm; pain at the injection site; swelling lymph nodes in armpits; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2022, the patient received the 1st dose of Shingrix (intramuscular). In August 2022, less than a week after receiving Shingrix, the patient experienced injection site pain and axillary lymph nodes enlarged. In September 2022, the patient experienced tingling. On an unknown date, the patient experienced back pain, shoulder pain, pain in arm, breast lump and ingrown hair. The patient was treated with antibiotics nos (Antibiotics Therapy (Unknown)). On an unknown date, the outcome of the injection site pain, back pain, shoulder pain and pain in arm were recovered/resolved and the outcome of the axillary lymph nodes enlarged and ingrown hair were unknown and the outcome of the breast lump and tingling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, axillary lymph nodes enlarged, back pain, shoulder pain, pain in arm, breast lump, ingrown hair and tingling to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-Oct-2022 Reporter's Comments: The reporter was the patient.  The patient received Shingrix dose in her left deltoid.  The patient initially had pain at the injection site and within the first week she noticed swelling to the lymph nodes in both armpits (swollen lymph nodes, unclear if resolved). The patient had left back and shoulder pain that radiated down her left arm.  The patient went to the ER (Emergency room) due to the pain and lymph node swelling. The patient developed a hard lump on the left side of her chest between her armpit and breast. The patient had regular mammograms. She saw her primary doctor who thought the lump might be an ingrown hair and prescribed an antibiotic.  The antibiotic did not resolve the lump. The patient was referred to a specialist who scheduled a mammogram.  About 3 to 5 weeks ago she experienced tingling in two fingers that was now progressing to her left palm. The patient did not have anything else to report. The reporter consent to follow up.
Age: 53.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Back pain, Breast mass, Ingrown hair, Injection site pain
Clinical narrative: had left back pain; had left shoulder pain; pain radiated down left arm; hard lump on side of chest between armpit and breast; ingrown hair; tingling in fingers and palm; pain at the injection site; swelling lymph nodes in armpits; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd August 2022, the patient received the 1st dose of Shingrix (intramuscular). In August 2022, less than a week after receiving Shingrix, the patient experienced injection site pain and axillary lymph nodes enlarged. In September 2022, the patient experienced tingling. On an unknown date, the patient experienced back pain, shoulder pain, pain in arm, breast lump and ingrown hair. The patient was treated with antibiotics nos (Antibiotics Therapy (Unknown)). On an unknown date, the outcome of the injection site pain, back pain, shoulder pain and pain in arm were recovered/resolved and the outcome of the axillary lymph nodes enlarged and ingrown hair were unknown and the outcome of the breast lump and tingling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, axillary lymph nodes enlarged, back pain, shoulder pain, pain in arm, breast lump, ingrown hair and tingling to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-Oct-2022 Reporter's Comments: The reporter was the patient.  The patient received Shingrix dose in her left deltoid.  The patient initially had pain at the injection site and within the first week she noticed swelling to the lymph nodes in both armpits (swollen lymph nodes, unclear if resolved). The patient had left back and shoulder pain that radiated down her left arm.  The patient went to the ER (Emergency room) due to the pain and lymph node swelling. The patient developed a hard lump on the left side of her chest between her armpit and breast. The patient had regular mammograms. She saw her primary doctor who thought the lump might be an ingrown hair and prescribed an antibiotic.  The antibiotic did not resolve the lump. The patient was referred to a specialist who scheduled a mammogram.  About 3 to 5 weeks ago she experienced tingling in two fingers that was now progressing to her left palm. The patient did not have anything else to report. The reporter consent to follow up.