chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Chills, Fatigue, Vaccination site pain
Clinical narrative: vaccination site pain; Chills; Fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; janssen covid-19 vaccine (JANSSEN COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 2, single for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "vaccination site pain"; CHILLS (non-serious), outcome "recovered" (2022), described as "Chills"; FATIGUE (non-serious), outcome "recovered" (2022), described as "Fatigue".  Additional information: The patient's height and weight were not reported. On an unspecified date, patient had significant side effects. Patient had fatigue and chills for day and fatigue for three (both events with dose number series 2). Patient had never had significant side effects from a vaccine before. Causality for events Fatigue and Chills  as per reporter (Drug/Vaccine) and Mfr was Possible.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Body temperature, Pain, Pyrexia
Clinical narrative: feverish and achy for 1-2days; feverish and achy for 1-2days; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 20 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Jan2022 (Lot number: FK9896) at the age of 20 years as dose 3 (booster), single for covid-19 immunisation; oxymetazoline hydrochloride (CLARITIN ALLERGIC), from 28Jan2022 (Batch/Lot number: unknown) to 28Jan2022 at 10 mg. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0170, Location of injection: Arm Left), administration date: 26Apr2021, when the patient was 20 years old, for COVID-19 immunization, reaction(s): "rash"; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8729, Location of injection: Arm Left), administration date: 01Apr2021, when the patient was 20 years old, for COVID-19 immunization, reaction(s): "rash". The following information was reported: PYREXIA (non-serious), PAIN (non-serious) all with onset 2022, outcome "recovered" (2022) and all described as "feverish and achy for 1-2days". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for oxymetazoline hydrochloride was unknown. Therapeutic measures were not taken as a result of pyrexia, pain.  Additional information: patient states he developed a rash on his torso 24hrs after his 1st and 2nd pfizer covid vaccines states symptoms/rash cleared on its own after couple days or so. Patient was given Claritin 10mg tab prior to his Pfizer covid 'booster' and watched for 30min, no problems, I called patient today 31Jan2022 to see if any rash developed over the weekend and he said NO. no rash developed this time however states he did feel feverish and achy for 1-2days (feels fine now).  No follow-up attempts are possible. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Joint range of motion decreased, Limb discomfort, Pain, SARS-CoV-2 test, Sleep disorder
Clinical narrative: Left arm constant discomfort; pain in the injection area; Interrupted sleep; Thropping pain at times; not a good range of motion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jan2022 12:15 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 18Jan2022, outcome "not recovered", described as "Left arm constant discomfort"; VACCINATION SITE PAIN (non-serious) with onset 18Jan2022, outcome "not recovered", described as "pain in the injection area"; SLEEP DISORDER (non-serious) with onset 18Jan2022, outcome "not recovered", described as "Interrupted sleep"; PAIN (non-serious) with onset 18Jan2022, outcome "not recovered", described as "Thropping pain at times"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 18Jan2022, outcome "not recovered", described as "not a good range of motion". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of limb discomfort, vaccination site pain, sleep disorder, pain, joint range of motion decreased.  Additional information: There was no other vaccine in four weeks and other medication in two weeks. Treatment included orthopedic visit Steriod/muscle relaxer. There was covid prior vaccination. Covid tested post vaccination. covid test name post vaccination was saliva. Known allergies was no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Left arm constant discomfort; pain in the injection area; Interrupted sleep; Thropping pain at times; not a good range of motion; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Jan2022 12:15 (Batch/Lot number: unknown) at the age of 59 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. The following information was reported: LIMB DISCOMFORT (non-serious) with onset 18Jan2022, outcome "not recovered", described as "Left arm constant discomfort"; VACCINATION SITE PAIN (non-serious) with onset 18Jan2022, outcome "not recovered", described as "pain in the injection area"; SLEEP DISORDER (non-serious) with onset 18Jan2022, outcome "not recovered", described as "Interrupted sleep"; PAIN (non-serious) with onset 18Jan2022, outcome "not recovered", described as "Thropping pain at times"; JOINT RANGE OF MOTION DECREASED (non-serious) with onset 18Jan2022, outcome "not recovered", described as "not a good range of motion". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of limb discomfort, vaccination site pain, sleep disorder, pain, joint range of motion decreased.  Additional information: There was no other vaccine in four weeks and other medication in two weeks. Treatment included orthopedic visit Steriod/muscle relaxer. There was covid prior vaccination. Covid tested post vaccination. covid test name post vaccination was saliva. Known allergies was no.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Nausea
Clinical narrative: extreme fatigue; nausea; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 78 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Lot number: FK9729) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "glaucoma" (unspecified if ongoing). Concomitant medication(s) included: ATORVASTATIN; AMLODIPINE; IBANDRONATE SODIUM; COSOPT. Past drug history included: Neurotin, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Previous dose details: , Prev dose product: COVID 19, Prev dose brand: pfizer, Prev dose brand unknown: False, Prev dose lot number: Pfizer, Prev dose lot unknown: False, Prev dose administration date: 10Sep2021, Prev dose administration time: 04:00 PM , Prev dose dose number: 2, Prev dose vaccine location: Right arm), administration date: 10Sep2021, when the patient was 78 years old, for COVID-19 Immunization; Bnt162b2 (Prev dose product: COVID 19, Prev dose brand: pfizer, Prev dose brand unknown: False, Prev dose lot number: EW0173, Prev dose lot unknown: False, Prev dose administration date: 20Aug2021, Prev dose administration time: 04:00 PM , Prev dose dose number: 1, Prev dose vaccine location: Right arm), administration date: 20Aug2021, when the patient was 78 years old, for covid 19 immunization. The following information was reported: FATIGUE (non-serious) with onset Feb2022, outcome "recovered", described as "extreme fatigue"; NAUSEA (non-serious) with onset Feb2022, outcome "recovered", described as "nausea". Therapeutic measures were not taken as a result of fatigue, nausea.  Additional information: Administration time: 11:00 AM. Facility type vaccine: Public Health Clinic/ Administration facility. patient did not receive other vaccine in four weeks. Other medications in two weeks: atorvastatin, amloipine, ibandronate sodium, cosop. Patient had no covid prior vaccination. Post vaccination, patient was not tested for COVID.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Lip pain
Clinical narrative: This is a spontaneous report received from contactable physician. Other case identifier: GL-020322-2775. A female patient received the 1st and 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), Apr 2021 and Mar 2021; both single dose, for COVID-19 immunisation. Patient also received Restylane (hyaluronic acid) injection, on Jan 21, 2022 (batch/lot# unknown). Medical history and concomitant medications not reported. The patient experienced erythema (redness), felt hot (warmth) and lip pain (painful to touch lip), onset 2022, with outcome of recovering. No therapeutic measures taken as a result of erythema, feeling hot and lip pain. Additional information included: Patient injected in the lips with Restylane Jan 21, 2022. The events persisted for 2 weeks and resolving at the time of report. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Pyrexia, Rash
Clinical narrative: Rash; Felt bad; Fever; This is a spontaneous report received from contactable consumer.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization.The following information was reported: RASH (non-serious), outcome "unknown", described as "Rash"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Felt bad"; PYREXIA (non-serious), outcome "unknown", described as "Fever".  Additional information: Pfizer employee reported that his sister in law had adverse events after the booster; he believes it was the Pfizer covid vaccine. His sister in law said she had a rash and also felt bad. Pfizer employee thinks she had a fever but he doesn't know when she got booster, he is pretty sure it was Pfizer's covid vaccine. Pfizer employee does not know the dates of the first, second or booster dose, and does not have any Lot numbers.   The lot number for BNT162B2 was not provided and will be requested during follow up.
Age: 36.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Autonomic nervous system imbalance, Postural orthostatic tachycardia syndrome
Clinical narrative: Re-emergence of dysautonomia/POTS symptoms.; Re-emergence of dysautonomia/POTS symptoms.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 28Oct2021 (Lot number: 320308D) at the age of 36 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA), administration date 28Oct2021 (Batch/Lot number: unknown) as dose number unknown, single. Relevant medical history included: "Crohns disease" (unspecified if ongoing), notes: I have crohn's disease; "Interchange of vaccine products" (unspecified if ongoing). Family history included: "Dysautonomia/POTS symptoms." (Unspecified if ongoing), notes: -Originally dx at age 17 with POTS but have not had tachycardia or needed medication for it in the last 10 years., -My sister developed a severe case of dysautonomia/ POTS.; "Autoimmune Issues" (unspecified if ongoing), notes: Have family history of autoimmune issues. Concomitant medication(s) included: APRISO; WELLBUTRIN; LOESTRIN; VIT D [COLECALCIFEROL]. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 007M20A), administration date: 29Jan2021, when the patient was 35 years old, for COVID-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: 037K20A), administration date: 01Jan2021, when the patient was 35 years old, for COVID-19 Immunization. The following information was reported: AUTONOMIC NERVOUS SYSTEM IMBALANCE (non-serious), POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious) all with onset 04Nov2021, outcome "not recovered" and all described as "Re-emergence of dysautonomia/POTS symptoms.". Therapeutic measures were not taken as a result of autonomic nervous system imbalance, postural orthostatic tachycardia syndrome.  Additional information: Seriousness criteria was no according Results in death, not Life threatening, did not Caused/prolonged no hospitalization, no Disabling/Incapacitating, no Congenital anomaly/birth defect. the patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Reported Event: Re-emergence of dysautonomia/POTS symptoms. Originally dx at age 17 with POTS but have not had tachycardia or needed medication for it in the last 10 years. Began having symptoms again shortly after booster. Has not resolved. Have family history of autoimmune issues. I have Crohn's disease. My sister developed a severe case of dysautonomia/ POTS in Apr after completing Moderna vaccines. My other sister has a history of Guillain-Barre. No Known allergies. Prior to vaccination, the patient did not diagnose with COVID-19. Since the vaccination, the patient did not get tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 5.0
Sex: U
Vaccine: COVID19, UNK
Symptoms: Poor quality product administered, Product administration error, Vaccination site reaction
Clinical narrative: injection site reaction; new bottle of diluent but it was expired, it was listed as 10 days after the manufacture date; new bottle of diluent but it was expired, it was listed as 10 days after the manufacture date; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from product quality group for a Pfizer sponsored program.  A 5 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Feb2022 12:35 (Lot number: FL0007) at the age of 5 years as dose 2, single for covid-19 immunisation; sodium chloride (SODIUM CHLORIDE), from 12Feb2022 12:35 (Batch/Lot number: unknown, Expiration Date: 01Feb2022) to 12Feb2022 12:35 at unk (diluent). The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Lot: FL0007, Anatomical site of injection: Left arm, Route of administration: Intramuscular), administration date: 22Jan2022, when the patient was 5 years old, for COVID-19 Immunization. The following information was reported: PRODUCT ADMINISTRATION ERROR (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious) all with onset 12Feb2022 12:35, outcome "unknown" and all described as "new bottle of diluent but it was expired, it was listed as 10 days after the manufacture date"; VACCINATION SITE REACTION (non-serious), outcome "unknown", described as "injection site reaction". The action taken for sodium chloride was unknown.  Additional Information: Caller clearly stated that, the vaccine was dilated with correct amount from a fresh bottle of sodium chloride on Saturday 12Feb2022 which was expired on 01Feb2022. It was a new bottle but it was expired, it was listed as 10 days after the manufacture date. It was a fresh new pop top sealed vial. Caller called to clarify if the patients need to be revaccinated. The second dose the patients have already received. It has been 21 days,  23 days on Wednesday since the first dose. Parents are concerned because this is a child dose. and there is a high rate of myocarditis with large doses, and wanted to know if they were  putting the children at risk. NDC number of BNT162B2 (dose 1 and dose 2) was 59267105501. Additional vaccines administered on same date were none. Prior Vaccinations (within 4 weeks) were and unknown hence, adverse events following prior vaccinations were unknown. Relevant tests were unknown. The patient provide information to you regarding the reported adverse event with the use of product was no and specific relevant test for thromboembolic events with thrombocytopenia were none. Did it affect the patient with clinical consequences: not as far as we have been made aware yet; sever-al check in calls have been made with the patient's guardian and no adverse effects have surfaced at this time.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200268460 same reporter/product/event, diff patients
Sex: F
Vaccine: PNC20
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site rash, Vaccination site swelling
Clinical narrative: pain redness and swelling at the injection site; pain redness and swelling at the injection site; pain redness and swelling at the injection site; A rash on the injection sight arm; This is a spontaneous report received from contactable reporter (Pharmacist) from a sales representative.  A 66-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20), administered in arm (Batch/Lot number: unknown) as dose number unknown, single for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE ERYTHEMA (non-serious), VACCINATION SITE SWELLING (non-serious), outcome "unknown" and all described as "pain redness and swelling at the injection site"; VACCINATION SITE RASH (non-serious), outcome "recovered", described as "A rash on the injection sight arm". Therapeutic measures were taken as a result of vaccination site rash. Additional information: the 66-year-old female patient who was the mother of the reporter received PNEUMOCOCCAL 20-VAL CONJ VAC (DIPHT CRM197 PROTEIN) and had pain, redness, and swelling at the injection site. The patient experienced a rash on the injection sight arm five days after receiving the vaccine. The patient reported the rash lasted for two days and was resolved after taking diphenhydramine hydrochloride (BENADRYL).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Abdominal discomfort, Nausea
Clinical narrative: sick at my stomach; sick at my stomach; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 21Feb2022 (Batch/Lot number: unknown) as dose 3 (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: 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: NAUSEA (non-serious), ABDOMINAL DISCOMFORT (non-serious) all with onset Feb2022, outcome "unknown" and all described as "sick at my stomach". Additional information: The patient stated, "Yes, I am calling about some of the side effects that I am having to see if that is was it is?" The patient then stated, "I had the, I took my booster, I had the, I am fully vaccinated, and I took my booster shot Monday." (Clarified the product name as Pfizer COVID-19 Vaccine).  When clarified if the patient was experiencing side effects after taking the booster of Pfizer COVID-19 Vaccine, the patient stated, "Yes, that's what I want to." The patient stated, "Yes, I have a doctor my primary doctor. I don't understand you. I'm not getting the straight of it. Well, listen thank you for helping me and I will try to get in touch with them tomorrow. I have been sick at my stomach (incomplete sentence)."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: PNC20, PPV
Symptoms: Circumstance or information capable of leading to medication error, Drug interaction, Incorrect dose administered
Clinical narrative: received Prevnar 20 as well as Pneumovax 23 and now wants to get Prevnar 20; received Prevnar 20 as well as Pneumovax 23 and now wants to get Prevnar 20; received Prevnar 20 as well as Pneumovax 23 and now wants to get Prevnar 20; This is a spontaneous report received from a contactable reporter (Pharmacist) from medical information team for a Pfizer sponsored program (004756).  A 52-year-old female patient received pneumococcal 20-val conj vac (dipht crm197 protein) (PREVNAR 20) (Batch/Lot number: unknown) as dose number unknown, single for immunization; pneumococcal vaccine polysacch 23v (PNEUMOVAX 23) (Batch/Lot number: unknown) as dose number unknown, single for immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INCORRECT DOSE ADMINISTERED (non-serious), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious), DRUG INTERACTION (non-serious), outcome "unknown" and all described as "received Prevnar 20 as well as Pneumovax 23 and now wants to get Prevnar 20". Additional information: The pharmacist was calling regarding a patient (52-year-old female) who had received pneumococcal 20-val conj vac (dipht crm197 protein) as well as pneumococcal vaccine polysacch 23v and now wanted to get pneumococcal 20-val conj vac (dipht crm197 protein). The pharmacist wanted to know what the "protocol" for doing so.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Breast mass, Breast swelling, Lymphadenopathy, Vaccination site pain
Clinical narrative: She reports lots of pain in her left arm where she got it; The whole breast on the left side was swollen."; Yesterday she found a "huge lump" in her left breast; I have been having pain in my left armpit; swollen lymph nodes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 44 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Breast implant" (unspecified if ongoing), notes: Patient history: Breast implant (From: Unspecified To: Unspecified). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "She reports lots of pain in her left arm where she got it"; BREAST SWELLING (non-serious), outcome "unknown", described as "The whole breast on the left side was swollen.""; BREAST MASS (non-serious), outcome "unknown", described as "Yesterday she found a "huge lump" in her left breast"; AXILLARY PAIN (non-serious), outcome "unknown", described as "I have been having pain in my left armpit"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "swollen lymph nodes".  Additional information: LOT number was reported as, could not see, it was small like F or E and then K9895, the label was cut at the bottom, so did not know. Also reported she had appointment with the Gynaecologist, but they did not have any open appointment something like in 2-3 months, so could not wait that long, this was crazy, and this was scary.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: HCP states she "has a patient who received their 1st dose of the PBCV on 21Sep2021 and then 90 days ago had Covid-19."; HCP states she "has a patient who received their 1st dose of the PBCV on 21Sep2021 and then 90 days ago had Covid-19."; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 21Sep2021 (Batch/Lot number: unknown) as dose 1, single 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) all with onset 02Dec2021, outcome "unknown" and all described as "HCP states she "has a patient who received their 1st dose of the PBCV on 21Sep2021 and then 90 days ago had Covid-19."".  Clinical information: HCP stated she "has a patient who received their 1st dose of the PBCV on 21Sep2021 and then 90 days ago had Covid-19." Does the patient now get the second dose or restart the PBCV series? HCP has no patient demographics available.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Based on the information in the case report and a plausible temporal relationship, a possible causal association between the events and suspect drug BNT162B2 cannot be excluded.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: A 42-year-old female who received the pediatric orange top vaccination; they had a tech administer the children Pfizer COVID vaccine to an adult, they gave the full 1 mL dose; This is a spontaneous report received from a contactable other healthcare professional from medical information team.  A 42-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 02Mar2022 (Lot number: FK5127) at the age of 42 years as dose 1, 1 ml single for COVID-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: A 42-year-old female received the orange top vaccination on 02Mar2022. They had a tech administer the wrong Pfizer COVID vaccine to an adult, they gave the full 1 mL dose. The reporter stated that the patient was not experiencing any side effects (as of report date). The reporter needed guidance on what to do. For the seriousness, the reporter mentioned that she was between the 2rd and 3rd options, medically significant and life-threatening, just because she didn't know, but maybe it is more the 2nd one, medically significant.; Sender's Comments: As there is limited information in the case provided, the causal association between the reported events and the suspect drug cannot be excluded. The case will be reassessed once new information is available.   The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Inappropriate schedule of product administration, Pericarditis, SARS-CoV-2 test
Clinical narrative: I got pericarditis; rare heart disease and this set me up bsically for failure; Inappropriate schedule of vaccine administered; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administered in arm left, administration date 13Jul2021 (Lot number: EW0191) at the age of 23 years as dose 2, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, SINGLE (Lot Number: EW0196) administered in left arm.), administration date: 03Mar2021, when the patient was 23 years old, for COVID-19 Immunization.  The following information was reported: PERICARDITIS (hospitalization, disability), outcome "not recovered", described as "I got pericarditis"; CARDIAC DISORDER (hospitalization, disability), outcome "not recovered", described as "rare heart disease and this set me up bsically for failure"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 13Jul2021, outcome "unknown", described as "Inappropriate schedule of vaccine administered ". The patient was hospitalized for pericarditis, cardiac disorder (hospitalization duration: 1 day(s)). The events "i got pericarditis" and "rare heart disease and this set me up bsically for failure" were evaluated at the physician office visit and emergency room visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (01Mar2022) negative, notes: Unknown. It was unknown if therapeutic measures were taken as a result of pericarditis, cardiac disorder.  Additional information: The patient got pericarditis. The patient has not gotten better since the second shot. The patient did not receive other vaccine in four weeks. The patient did not have COVID prior vaccination.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Diarrhoea, Dizziness, Dyspepsia, Ear pain
Clinical narrative: Numbness; tingling; dizziness; vertigo; diarrhea; heartburn; head pain; ear pain; tinnitus; joint pain; flushing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 13:30 (Lot number: EW0153) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TAMOXIFEN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (dose 1, lot number: ER2613, administration time: 01:30PM , vaccine location: Left arm), administration date: 24Mar2021, when the patient was 47 years old, for COVID-19 immunization. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: HYPOAESTHESIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "Numbness"; PARAESTHESIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "tingling"; DIZZINESS (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "dizziness"; VERTIGO (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "vertigo"; DIARRHOEA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "diarrhea"; DYSPEPSIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "heartburn"; HEADACHE (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "head pain"; EAR PAIN (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "ear pain"; TINNITUS (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "tinnitus"; ARTHRALGIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "joint pain"; FLUSHING (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "flushing". The events "numbness", "tingling", "dizziness", "vertigo", "diarrhea", "heartburn", "head pain", "ear pain", "tinnitus", "joint pain" and "flushing" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) negative. Therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, dizziness, vertigo, diarrhoea, dyspepsia, headache, ear pain, tinnitus, arthralgia, flushing on an unspecified date in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Flushing, Headache, Hypoaesthesia, Paraesthesia, SARS-CoV-2 test
Clinical narrative: Numbness; tingling; dizziness; vertigo; diarrhea; heartburn; head pain; ear pain; tinnitus; joint pain; flushing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 13:30 (Lot number: EW0153) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TAMOXIFEN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (dose 1, lot number: ER2613, administration time: 01:30PM , vaccine location: Left arm), administration date: 24Mar2021, when the patient was 47 years old, for COVID-19 immunization. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: HYPOAESTHESIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "Numbness"; PARAESTHESIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "tingling"; DIZZINESS (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "dizziness"; VERTIGO (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "vertigo"; DIARRHOEA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "diarrhea"; DYSPEPSIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "heartburn"; HEADACHE (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "head pain"; EAR PAIN (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "ear pain"; TINNITUS (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "tinnitus"; ARTHRALGIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "joint pain"; FLUSHING (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "flushing". The events "numbness", "tingling", "dizziness", "vertigo", "diarrhea", "heartburn", "head pain", "ear pain", "tinnitus", "joint pain" and "flushing" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) negative. Therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, dizziness, vertigo, diarrhoea, dyspepsia, headache, ear pain, tinnitus, arthralgia, flushing on an unspecified date in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Tinnitus, Vertigo
Clinical narrative: Numbness; tingling; dizziness; vertigo; diarrhea; heartburn; head pain; ear pain; tinnitus; joint pain; flushing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 13:30 (Lot number: EW0153) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TAMOXIFEN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (dose 1, lot number: ER2613, administration time: 01:30PM , vaccine location: Left arm), administration date: 24Mar2021, when the patient was 47 years old, for COVID-19 immunization. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: HYPOAESTHESIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "Numbness"; PARAESTHESIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "tingling"; DIZZINESS (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "dizziness"; VERTIGO (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "vertigo"; DIARRHOEA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "diarrhea"; DYSPEPSIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "heartburn"; HEADACHE (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "head pain"; EAR PAIN (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "ear pain"; TINNITUS (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "tinnitus"; ARTHRALGIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "joint pain"; FLUSHING (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "flushing". The events "numbness", "tingling", "dizziness", "vertigo", "diarrhea", "heartburn", "head pain", "ear pain", "tinnitus", "joint pain" and "flushing" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) negative. Therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, dizziness, vertigo, diarrhoea, dyspepsia, headache, ear pain, tinnitus, arthralgia, flushing on an unspecified date in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Acoustic stimulation tests, Allergy test, Antinuclear antibody, Arthritis, Blood glucose
Clinical narrative: Numbness; tingling; dizziness; vertigo; diarrhea; heartburn; head pain; ear pain; tinnitus; joint pain; flushing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 13:30 (Lot number: EW0153) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TAMOXIFEN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (dose 1, lot number: ER2613, administration time: 01:30PM , vaccine location: Left arm), administration date: 24Mar2021, when the patient was 47 years old, for COVID-19 immunization. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: HYPOAESTHESIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "Numbness"; PARAESTHESIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "tingling"; DIZZINESS (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "dizziness"; VERTIGO (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "vertigo"; DIARRHOEA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "diarrhea"; DYSPEPSIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "heartburn"; HEADACHE (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "head pain"; EAR PAIN (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "ear pain"; TINNITUS (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "tinnitus"; ARTHRALGIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "joint pain"; FLUSHING (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "flushing". The events "numbness", "tingling", "dizziness", "vertigo", "diarrhea", "heartburn", "head pain", "ear pain", "tinnitus", "joint pain" and "flushing" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) negative. Therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, dizziness, vertigo, diarrhoea, dyspepsia, headache, ear pain, tinnitus, arthralgia, flushing on an unspecified date in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood test, Computerised tomogram, Diarrhoea, Dizziness, Dyspepsia
Clinical narrative: Numbness; tingling; dizziness; vertigo; diarrhea; heartburn; head pain; ear pain; tinnitus; joint pain; flushing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 13:30 (Lot number: EW0153) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TAMOXIFEN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (dose 1, lot number: ER2613, administration time: 01:30PM , vaccine location: Left arm), administration date: 24Mar2021, when the patient was 47 years old, for COVID-19 immunization. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: HYPOAESTHESIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "Numbness"; PARAESTHESIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "tingling"; DIZZINESS (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "dizziness"; VERTIGO (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "vertigo"; DIARRHOEA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "diarrhea"; DYSPEPSIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "heartburn"; HEADACHE (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "head pain"; EAR PAIN (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "ear pain"; TINNITUS (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "tinnitus"; ARTHRALGIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "joint pain"; FLUSHING (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "flushing". The events "numbness", "tingling", "dizziness", "vertigo", "diarrhea", "heartburn", "head pain", "ear pain", "tinnitus", "joint pain" and "flushing" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) negative. Therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, dizziness, vertigo, diarrhoea, dyspepsia, headache, ear pain, tinnitus, arthralgia, flushing on an unspecified date in May2021.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Ear pain, Electronystagmogram, Headache, Inflammatory marker test, Laboratory test
Clinical narrative: Numbness; tingling; dizziness; vertigo; diarrhea; heartburn; head pain; ear pain; tinnitus; joint pain; flushing; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 14Apr2021 13:30 (Lot number: EW0153) at the age of 47 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TAMOXIFEN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (dose 1, lot number: ER2613, administration time: 01:30PM , vaccine location: Left arm), administration date: 24Mar2021, when the patient was 47 years old, for COVID-19 immunization. Patient had no known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19; and since the vaccination, has been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  The following information was reported: HYPOAESTHESIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "Numbness"; PARAESTHESIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "tingling"; DIZZINESS (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "dizziness"; VERTIGO (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "vertigo"; DIARRHOEA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "diarrhea"; DYSPEPSIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "heartburn"; HEADACHE (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "head pain"; EAR PAIN (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "ear pain"; TINNITUS (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "tinnitus"; ARTHRALGIA (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "joint pain"; FLUSHING (disability) with onset 26Apr2021 10:00, outcome "not recovered", described as "flushing". The events "numbness", "tingling", "dizziness", "vertigo", "diarrhea", "heartburn", "head pain", "ear pain", "tinnitus", "joint pain" and "flushing" were evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (21Jan2022) negative. Therapeutic measures were taken as a result of hypoaesthesia, paraesthesia, dizziness, vertigo, diarrhoea, dyspepsia, headache, ear pain, tinnitus, arthralgia, flushing on an unspecified date in May2021.  No follow-up attempts are possible. No further information is expected.