chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Panic attack, Paraesthesia, Vaccination site bruising, Vaccination site pain
Clinical narrative: tingling in the arm at site of injection; slight bruising an pain at injection site.; slight bruising an pain at injection site.; panic attack; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 53 year-old female patient received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine) (Batch/Lot number: unknown), in the arm, as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PARAESTHESIA (non-serious), outcome "unknown", described as "tingling in the arm at site of injection"; PANIC ATTACK (non-serious), outcome "recovered", described as "panic attack"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE BRUISING (non-serious), outcome "unknown" and all described as "slight bruising and pain at injection site.".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hepatic enzyme increased
Clinical narrative: This is a spontaneous report received from a contactable other HCP, who reported similar events for 3 patients. This report is for 2nd patient. An adult patient received unknown dose number of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history not reported. There were no concomitant medications. The patient had increased hepatic enzymes (elevated liver enzymes), onset May 10, 2021, with outcome of not recovered. Relevant laboratory tests and procedures available in the appropriate section. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: after getting her second dose of COVID vaccine was sick; This is a spontaneous report from a contactable consumer, based on the information received by Pfizer (manufacturer control number: US-AMGEN-USASP2021081162).  A 61 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Gastroesophageal reflux disease" (ongoing); "Rheumatoid arthritis" (ongoing). Concomitant medication(s) included: ENBREL taken for gastrooesophageal reflux disease, rheumatoid arthritis; TRAZODONE HCL; OMEPRAZOLE; PANTOPRAZOLE; GABAPENTIN; PANTOPRAZOLE SODIUM; PLAVIX; NICODERM CQ; ALCOHOL SWABS [ETHANOL]; VICODIN. Vaccination history included: Bnt162b2 (1st Dose), for COVID-19 immunization.  The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "after getting her second dose of COVID vaccine was sick".  Additional information: This non-serious spontaneous report involves an approximately 62 year old (as reported) female patient who missed a dose of her Enbrel due to developing flu like symptoms [PT: influenza like illness] and after getting her second dose of COVID vaccine was sick [PT: illness] while receiving Enbrel, Single Dose Prefilled Autoinjector. No historical medical condition was reported. No co-suspect medications were reported. The patient began Enbrel with Single Dose Prefilled Autoinjector on an unknown date. On an unknown date, the patient missed a dose of her Enbrel due to developing flu like symptoms. On an unknown date, after getting her second dose of COVID vaccine, she was sick and decided not to take Enbrel. Patient stated she has already spoken about it with her physician. No treatment information was received. Action taken with Enbrel and Single Dose Prefilled Autoinjector was temporarily withheld for the event influenza like illness. The causal relationship between the events influenza like illness, illness and Enbrel with Single Dose Prefilled Autoinjector was not provided by the consumer. The reporter declined consent for follow up.    No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Flushing, Food allergy, Lymphadenopathy, Sinusitis
Clinical narrative: After 2nd Vax sensitivity turned into full blown allergic reaction to ALL meat product; Immediate flush reaction in face.; Sinuses and lymph nodes swell up; Sinuses and lymph nodes swell up; 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 male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 03May2021 (Batch/Lot number: unknown) at the age of 47 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "shellfish" (unspecified if ongoing), notes: Shellfish; "Meat" (unspecified if ongoing), notes: Seemed to have a sensitivity to meat. The patient took concomitant medications. Vaccination history included: Bnt162b2 (product=COVID 19, brand=Phizer, lot number=EW0151, lot unknown=False, administration date=12Apr2021, administration time=09:30 AM, dose number=1, vaccine location=Left arm, No appetite for two weeks on 1st Vax), administration date: 12Apr2021, when the patient was 47 years old, for Covid-19 immunization, reaction(s): "No appetite for two weeks on 1st Vax". The following information was reported: FOOD ALLERGY (non-serious) with onset 04May2021 07:00, outcome "not recovered", described as "After 2nd Vax sensitivity turned into full blown allergic reaction to ALL meat product"; FLUSHING (non-serious) with onset 04May2021 07:00, outcome "not recovered", described as "Immediate flush reaction in face."; LYMPHADENOPATHY (non-serious), SINUSITIS (non-serious) all with onset 04May2021 07:00, outcome "not recovered" and all described as "Sinuses and lymph nodes swell up".  Additional information: No other vaccine was given in four weeks. Allergy Medication was taken in two weeks. Attempted Vegan/vegetarian food for the last 4 weeks since second dose. Although a major life adjustment, has not had any reactions. Had tested once a week with various meat. Same result. The patient got the instant vegan shot. No covid prior vaccination taken. Not tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Abdominal distension, Swelling
Clinical narrative: underarm swelling (from day of first injection continuing still); stomach bloating and discomfort about 10 days after second dose; stomach bloating and discomfort about 10 days after second dose; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient (not pregnant) received BNT162B2 (Pfizer-BioNTech COVID-19 mRNA vaccine), administered in arm right, administration date 10Mar2021 09:15 (Lot number: EN6204) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing); "depression" (unspecified if ongoing); "Sulfa" (unspecified if ongoing). Concomitant medication(s) included: ACIPHEX; CRESTOR; DESVENLAFAXINE; LEVOTHYROXINE. Past drug history included: Azithromycin, reaction(s): "Allergies: Azithromycin"; Xanax, reaction(s): "Allergies: Xanax". Vaccination history included: Bnt162b2 (LotEL9266, time09:30AM, location Right arm, Dose1, fatigue resulting in sleeping 14 hrs+/day for 3 days), administration date: 17Feb2021, when the patient was 72 years old, for Covid-19 immunisation, reaction(s): "fatigue resulting in sleeping 14 hrs =/day for 3 days", "fatigue resulting in sleeping 14 hrs =/day for 3 days", "Muscle pain", "Joint pain", "underarm swelling". The following information was reported: SWELLING (non-serious), outcome "not recovered", described as "underarm swelling (from day of first injection continuing still)"; ABDOMINAL DISTENSION (non-serious), ABDOMINAL DISCOMFORT (non-serious) all with onset Mar2021, outcome "not recovered" and all described as "stomach bloating and discomfort about 10 days after second dose". Therapeutic measures were not taken as a result of swelling, abdominal distension, abdominal discomfort. Clinical course: Patient reported underarm swelling (from day of first injection continuing still), stomach bloating and discomfort about 10 days after second dose, continuing still. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Facility where the most recent COVID-19 vaccine was administered was at a Public Health facility. Since the vaccination, the patient has not been tested for COVID- 19.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: U
Vaccine: COVID19
Symptoms: Cough, Respiratory tract congestion
Clinical narrative: chest congestion; severe cough; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 71 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 26Jul2021 (Lot number: FA7485) at the age of 71 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "'otoro' hysterectomy", start date: 1978 (unspecified if ongoing); "Hypothyroid" (unspecified if ongoing); "allergic to iodine" (unspecified if ongoing); "allergic" (unspecified if ongoing), notes: I am allergic to a lot of things (further clarifications unknown). Concomitant medication(s) included: SYNTHROID taken for hypothyroidism, start date: 1979 (ongoing); DELESTROGEN taken for hysterectomy (ongoing). The following information was reported: RESPIRATORY TRACT CONGESTION (non-serious) with onset 11Aug2021, outcome "recovered" (Aug2021), described as "chest congestion"; COUGH (non-serious) with onset 11Aug2021, outcome "recovered" (Aug2021), described as "severe cough".  Additional information: The concomitant medications included Delestrogen and Synthroid which the patient was taking that for almost 50 years. The patient was vaccinated at on 26Jul2021 and on 11Aug2021, 12Aug2021 and 13Aug2021 developed chest congestion with severe cough, but they subsided. Prior vaccination (Within 4 weeks) was none.  No follow-up attempts are possible. No further information is expected.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, SARS-CoV-2 test
Clinical narrative: severe arm and leg pain on left side.; severe arm and leg pain on left side.; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17Sep2021 (Batch/Lot number: unknown) at the age of 43 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE taken for immunisation, administration date 17Sep2021. The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 17Sep2021, outcome "recovered" (2021) and all described as "severe arm and leg pain on left side.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, pain in extremity.  Additional information- It was reported that Prior to vaccination,  the patient was not diagnosed with COVID-19 and Since the vaccination,  the patient had been tested for COVID-19   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity, SARS-CoV-2 test, Swelling
Clinical narrative: severe arm and leg pain on left side.; severe arm and leg pain on left side.; numbness in both arm; numbness/leg on left side; Left side of my face went numb; I also developed a large lump on the left side of my neck that lasted for 6 weeks; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 08Oct2021 (Batch/Lot number: unknown) at the age of 43 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, administration date 17Sep2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left), administration date: 17Sep2021, when the patient was 43 years old, for Covid-19 Immunization, reaction(s): "severe arm and leg pain on left side", "severe arm and leg pain on left side". The following information was reported: PAIN IN EXTREMITY (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 2021, outcome "recovered" (2022) and all described as "severe arm and leg pain on left side."; HYPOAESTHESIA (non-serious) with onset 2021, outcome "recovered" (2022), described as "numbness in both arm"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "recovered" (2022), described as "numbness/leg on left side"; HYPOAESTHESIA (non-serious) with onset 2021, outcome "recovered" (2022), described as "Left side of my face went numb"; SWELLING (non-serious) with onset 2021, outcome "recovered" (2022), described as "I also developed a large lump on the left side of my neck that lasted for 6 weeks". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, pain in extremity, hypoaesthesia, hypoaesthesia, hypoaesthesia, swelling. Reported Event: After both the first and second dose severe arm and leg pain on left side.  After second shot along with the severe pain numbness in both arm and leg on left side as well as the left side of her face went numb for about 24 hours. The patient also developed a large lump on the left side of her neck that lasted for 6 weeks.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Pyrexia, Vaccination site pain
Clinical narrative: Mild fever; Pain at the injection site; General malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 15 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. 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: PYREXIA (non-serious), outcome "recovered", described as "Mild fever"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Pain at the injection site"; MALAISE (non-serious), outcome "unknown", described as "General malaise". Therapeutic measures were taken as a result of pyrexia, vaccination site pain, malaise.  Additional information: Reporter son developed the expected side effects of mild fever, pain at the injection site, and general malaise after receiving his 3rd shot. treated with Advil and fever resolved. withheld is a healthy 15-year-old with no underlying conditions. Takes a daily multivitamin. Reporter wasn't sure how long or what other side effects/adverse events my kids might develop, so  wasn't sure of the best time to report.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever; Chills; Ache; 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 (COMIRNATY), administration date 07Jan2022 (Lot number: PL03198) 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: PYREXIA (non-serious) with onset 08Jan2022, outcome "unknown", described as "Fever"; CHILLS (non-serious) with onset 08Jan2022, outcome "unknown", described as "Chills"; PAIN (non-serious) with onset 08Jan2022, outcome "unknown", described as "Ache". No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Nasal congestion
Clinical narrative: congestion; but believes it to be allergies; This is a spontaneous report received from a contactable reporter (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASAL CONGESTION (non-serious), outcome "unknown", described as "congestion"; HYPERSENSITIVITY (non-serious), outcome "unknown", described as "but believes it to be allergies". Additional information: The reporter was a patient who was scheduled to receive her booster dose of the Pfizer-BioNTech COVID-19 vaccine, the day after the initial report. The patient reported having had "congestion for a couple of months" but believed it to be allergies. The patient noted that her daily activities were not limited, "I still go golfing and go to work".  The patient wanted to know if she could still receive the booster dose with the symptom. The patient noted that her original vaccination series was also Pfizer.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Malaise, Mobility decreased, Musculoskeletal stiffness, Pain
Clinical narrative: had experienced long term pain; can't lift her left arm up above her head; can't move her arm to the left or to the right; arm hurts, in constant pain; stiffness up in her neck; She is not feeling too well with her left arm being like this; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Lot number: FC3183) at the age of 60 years as dose 2, single and administered in arm left, administration date 13Sep2021 (Lot number: FD8448) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN (non-serious), outcome "unknown", described as "had experienced long term pain"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "can't lift her left arm up above her head; can't move her arm to the left or to the right"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm hurts, in constant pain"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiffness up in her neck"; MALAISE (non-serious), outcome "unknown", described as "She is not feeling too well with her left arm being like this". The events "had experienced long term pain", "can't lift her left arm up above her head; can't move her arm to the left or to the right", "arm hurts, in constant pain", "stiffness up in her neck" and "she is not feeling too well with her left arm being like this" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller mentions she takes thyroid medicine, but she has been taking thyroid medicine for the past 5 years. The caller confirms her arm was doing fine before she took the shot. Now, she is having stiffness up in her neck. She is not feeling too well with her left arm being like this. Dose 2 time of vaccination: it was after 12 she knows, and then she had to stay in the store for like 10 minutes. Caller states she did go see the doctor and told the doctor her arm was hurting really, really bad. The caller explains she had a knot and was rubbing it and stuff, but nothing's gone away. Prior Vaccinations (within 4 weeks/within four weeks prior to the first administration date of the suspect vaccine was none. Never had adverse event prior vaccination. No illness at time of vaccination. She hasn't had x-rays or anything like that on her left arm. She didn't fall or didn't do anything to it.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had experienced long term pain; can't lift her left arm up above her head; can't move her arm to the left or to the right; arm hurts, in constant pain; stiffness up in her neck; She is not feeling too well with her left arm being like this; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 60 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Oct2021 (Lot number: FC3183) at the age of 60 years as dose 2, single and administered in arm left, administration date 13Sep2021 (Lot number: FD8448) as dose 1, single for covid-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. The following information was reported: PAIN (non-serious), outcome "unknown", described as "had experienced long term pain"; MOBILITY DECREASED (non-serious), outcome "unknown", described as "can't lift her left arm up above her head; can't move her arm to the left or to the right"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "arm hurts, in constant pain"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "unknown", described as "stiffness up in her neck"; MALAISE (non-serious), outcome "unknown", described as "She is not feeling too well with her left arm being like this". The events "had experienced long term pain", "can't lift her left arm up above her head; can't move her arm to the left or to the right", "arm hurts, in constant pain", "stiffness up in her neck" and "she is not feeling too well with her left arm being like this" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The caller mentions she takes thyroid medicine, but she has been taking thyroid medicine for the past 5 years. The caller confirms her arm was doing fine before she took the shot. Now, she is having stiffness up in her neck. She is not feeling too well with her left arm being like this. Dose 2 time of vaccination: it was after 12 she knows, and then she had to stay in the store for like 10 minutes. Caller states she did go see the doctor and told the doctor her arm was hurting really, really bad. The caller explains she had a knot and was rubbing it and stuff, but nothing's gone away. Prior Vaccinations (within 4 weeks/within four weeks prior to the first administration date of the suspect vaccine was none. Never had adverse event prior vaccination. No illness at time of vaccination. She hasn't had x-rays or anything like that on her left arm. She didn't fall or didn't do anything to it.
Sex: U
Vaccine: COVID19
Symptoms: Muscular weakness
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP. A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced muscular weakness/arm weakness, with outcome of unknown. Additional information: Patient experienced arm weakness within 24 hours of 1st shot of Pfizer vaccine. The batch/lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Sinus congestion, Upper respiratory tract congestion
Clinical narrative: nose, throat and sinus congestion; nose, throat and sinus congestion; nose, throat and sinus congestion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient. A female patient received BNT162b2 (BNT162B2) (Batch/Lot number: unknown) 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, Lot number: unknown), for COVID-19 immunization. The following information was reported: NASAL CONGESTION (non-serious), SINUS CONGESTION (non-serious), UPPER RESPIRATORY TRACT CONGESTION (non-serious), outcome "not recovered" and all described as "nose, throat and sinus congestion". Additional information: The patient called to ask if it was OK to take the booster dose next week. She was currently experiencing nose, throat and sinus congestion. Two doses of the COVID vaccine had been taken.  The lot number for BNT162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Poor quality product administered, Product administration error
Clinical narrative: the vaccine was administered after it was stored for 3 days past the 31 days that are labeled; the vaccine was administered after it was stored for 3 days past the 31 days that are labeled; the vaccine was administered after it was stored for 3 days past the 31 days that are labeled; This case is considered as invalid as RA-unidentifiable patient: no patient identifiers reported.  This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 11Jan2022 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious), POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT ADMINISTRATION ERROR (non-serious) all with onset 11Jan2022 and all described as "the vaccine was administered after it was stored for 3 days past the 31 days that are labeled".  Additional information: Caller is a Pharmacist calling on behalf of a (withheld). She called to ask for guidance of an administration of the Pfizer Biontech COVID 19 vaccine adult formulation (purple cap) after improper handling and storage. Caller stated that in one of the clinics the vaccine was administered after it was stored for 3 days past the 31 days that are labeled. Caller stated 5 patients were involved, however she did not mentioned genders nor ages. Type of dose (first, second or booster) was unknown. She mentioned she assumes the vaccines were administered yesterday 11Jan2022.Responded as per attached document. Under Table 1. Summary of Data to Support Inadvertent Excursions to the Labeled Storage Condition for Frozen or Thawed, Undiluted Vaccine1,3,4. 2 degree C to 8 degree C (35 degree F to 46 degree F). Total time: 32 days = 31 days labeled time described in the Prescribing Information plus 1 day excursion time. No information to support excursion.   Follow-up attempts are completed. No further information is expected.  Amendment: This follow up report is being submitted to amend previously reported information: removed age group "Adult" and reassessed the case as invalid.
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Overdose
Clinical narrative: headache; received all "6 doses" of the Pfizer COVID 19 vaccine, Grey cap, already diluted vial/She confirmed the patient received the full vial as the dose administered and not just 0.3mL; This is a spontaneous report received from a contactable reporter(s) (Pharmacist) from medical information team.  A 17 year-old male patient received bnt162b2 (COMIRNATY), administration date 11Jan2022 (Batch/Lot number: unknown) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1, SINGLE, Manufacturer Unknown), for Covid-19 Immunization. The following information was reported: OVERDOSE (non-serious) with onset 11Jan2022, outcome "unknown", described as "received all "6 doses" of the Pfizer COVID 19 vaccine, Grey cap, already diluted vial/She confirmed the patient received the full vial as the dose administered and not just 0.3mL"; HEADACHE (non-serious) with onset 12Jan2022, outcome "unknown", described as "headache". The event "received all "6 doses" of the pfizer covid 19 vaccine, grey cap, already diluted vial/she confirmed the patient received the full vial as the dose administered and not just 0.3ml" was evaluated at the emergency room visit.  Additional information: The patient believed he got the entire vial of the Grey Cap Covid Vaccine for his dose. The nurse that administered the vaccine made a mistake and drew up the entire vial and administered it to the patient. Pharmacy usually drew it up and sent the prepared syringes to the doctor's office, but this time the doctor's office had the vials and filled the syringe themselves and made the dosage error. The patient reported a headache the next day but no temperature changes or GI changes were there.  Follow-up (04Feb2022): New information from a contactable Pharmacist included: vaccination facility type , new event headache added, suspect drug detail (dose: 3). Event off-label use was deleted as booster is approved for grey cap vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Rash
Clinical narrative: rash; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Feb2021 (Lot number: 9262, Expiration Date: May2021) at the age of 70 years as dose 1, 30 ug single and administration date 09Mar2021 (Lot number: EN6201, Expiration Date: Jun2020) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Verbatim: Blood pressure" (unspecified if ongoing), notes: Verbatim: Blood pressure; "Verbatim: Stage 3 kidney disease" (unspecified if ongoing), notes: Verbatim: Stage 3 kidney disease. Concomitant medication(s) included: FLU. The following information was reported: RASH (non-serious) with onset 2021, outcome "unknown", described as "rash". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: on an unknown date, the patient's body scan was no infection and nothing looks loose.  No follow-up attempts are possible. No further information is expected.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: After second shot I had extended menstrual; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 26Mar2021 (Lot number: Er8732) at the age of 51 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Muscle spasms" (unspecified if ongoing); "Anemia" (unspecified if ongoing); "mitral valve prolapse" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D3; BACLOFEN; TYLENOL; ZINC. Past drug history included: Flagyl, reaction(s): "Allergy: Flagyl". Vaccination history included: Bnt162b2 (dose number-1, lot number- En6204, vaccine location-Right arm), administration date: 05Mar2021, when the patient was 51 years old, for Covid-19 Immunization. The following information was reported: OLIGOMENORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "After second shot I had extended menstrual".  Follow-up attempts are completed. No further information is expected.
Age: 12.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Rash
Clinical narrative: her face is very red; rash all over her face; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from medical information team. The reporter is the parent.  A 12-year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 10Jan2022 15:45 (Lot number: 33036BD) at the age of 12 years as dose 1, 0.3 ml single for covid-19 immunisation. Relevant medical history included: "Asthma" (ongoing). There were no concomitant medications. The following information was reported: RASH (non-serious) with onset 10Jan2022 21:15, outcome "not recovered", described as "rash all over her face"; ERYTHEMA (non-serious) with onset 12Jan2022, outcome "unknown", described as "her face is very red". Therapeutic measures were taken as a result of rash, erythema.  Additional information: The reporter who was a pharmacist stated that she gave her daughter the first dose of the Comirnaty vaccine in left arm on Monday 10Jan2022 and that the rash started on same day and by Tuesday 11Jan2022 her daughter's entire face was covered, and today 12Jan2022 her face was very red. She said that she treated her daughter's rash with Benadryl gel and said that the rash keeps changing and that was what concerning to her. It was really red and almost like it was white heads all over her face now. She said that she has never seen this reaction before. The reporting parent asked about any information on reports of children 12 years and older that developed a rash on the face following administration of COMIRNATY and what was the percentage. Dates for Comirnaty: (10Jan2022). NDC number of Comirnaty: 59267100002 and confirmed this was the adult dose of the Comirnaty vaccine. Vaccination Facility Type: Pharmacy. No history of all previous immunization with the Pfizer vaccine considered as suspect (or patient age at first and subsequent immunizations if dates of birth or immunizations are not available). No additional Vaccines Administered on Same Date of the Pfizer Suspect. The start time of the event was unknown but noticed it when she got home from work at about 2115 10Jan2022. The events did not require a visit to Emergency Room or Physician Office. Prior Vaccinations (within 4 weeks) was none. AE(s) following prior vaccinations was none. Family Medical History Relevant to AE(s) was none. Relevant Tests were none, she has just been monitoring her daughter herself.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Discomfort, Musculoskeletal stiffness, Pain, Vaccination site pain, Vaccination site reaction
Clinical narrative: Discomforts subside; General stiffness; Mild aches; Soreness and stiffness at injection site; Soreness and stiffness at injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 12Jan2022 10:15 (Lot number: FL3197) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE; Lot Number: EL3247; Administration Time: 13:00; Anatomical Location: Right leg; Route of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 58 years old, for COVID-19 immunisation, reaction(s): "Vaccine administered at inappropriate site"; Bnt162b2 (DOSE 2, SINGLE; Lot Number: EP6955; Administration Time: 11:00; Anatomical Location: Right arm; Route of Administration: Intramuscular), administration date: 26Mar2021, when the patient was 58 years old, for COVID-19 immunisation. The following information was reported: MUSCULOSKELETAL STIFFNESS (non-serious) with onset 12Jan2022 19:00, outcome "recovered" (13Jan2022 12:00), described as "General stiffness"; PAIN (non-serious) with onset 12Jan2022 19:00, outcome "recovered" (13Jan2022 12:00), described as "Mild aches"; VACCINATION SITE PAIN (non-serious), VACCINATION SITE REACTION (non-serious) all with onset 12Jan2022 19:00, outcome "recovered" and all described as "Soreness and stiffness at injection site"; DISCOMFORT (non-serious) with onset 13Jan2022 19:00, outcome "recovered", described as "Discomforts subside". Therapeutic measures were taken as a result of musculoskeletal stiffness, pain, vaccination site pain, vaccination site reaction, discomfort.  Additional Information: The patient had no known allergies. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctors or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Prior vaccinations (within 4 weeks) was none. Specific relevant test for thromboembolic events with thrombocytopenia was none. Only treatment (13Jan) was 400 mg Advil.  No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: intermittent right arm/elbow pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): NVSC2021US144922_NS.  A 68 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 68 years as dose number unknown (booster), single for covid-19 immunisation. 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "intermittent right arm/elbow pain". Additional information: Relationship to patient: self. Event : The patient stated that he received Covid-19 Vaccine and Covid Booster and since then had experienced intermittent right arm/elbow pain.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: cold; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), outcome "not recovered", described as "cold". Additional information:  He got the vaccine, and 2 months later, he had a cold that lasted for 2 months, then let up for about 10 days, and came back again. He attributed this to the vaccine modifying spike proteins.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Bone pain
Clinical narrative: bones have been hurting since taking the shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 54 year-old male patient received bnt162b2 (BNT162B2), administration date 12Dec2021 (Batch/Lot number: unknown) as dose number unknown (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 2,Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 1,Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: BONE PAIN (non-serious) with onset Dec2021, outcome "unknown", described as "bones have been hurting since taking the shot". Addition information: Patient took the booster 12Dec and his bones have been hurting since taking the shot. Reporter did not want him to take the booster but he took it and now he was in pain.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Bladder disorder, Bladder prolapse, Investigation, Pain
Clinical narrative: Bladder comes down when she goes to the bathroom and hurts like hell; bladder disorder scheduled for surgery; Bladder comes down when she goes to the bathroom and hurts like hell; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 80 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, single and (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "bladder disorder" (ongoing), notes: (She had it before but it was not affecting her like now). The patient's concomitant medications were not reported. The following information was reported: BLADDER PROLAPSE (medically significant), PAIN (non-serious), outcome "not recovered" and all described as "Bladder comes down when she goes to the bathroom and hurts like hell"; BLADDER DISORDER (medically significant), outcome "not recovered", described as "bladder disorder scheduled for surgery". She was having surgery on Tuesday on her bladder. She had it before but it was not affecting her like now. They put something on her, but it kept coming down. They were going to cut in the middle and try to fix it. It started 3-4 months ago. The patient later had booster dose of BNT162B2 on an unspecified date on her arm. The patient underwent the following laboratory tests and procedures: investigation: unknown results. The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Penis disorder
Clinical narrative: getting yellow green puss coming out of his penis; 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 (COMIRNATY) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PENIS DISORDER (non-serious), outcome "unknown", described as "getting yellow green puss coming out of his penis".  Additional information: Clinical course: It was reported that ever since the patient took the Pfizer Comirnaty vaccine, he was getting yellow green puss coming out of his penis. Patient wants to know is this a common side should the patient scrape some off and send it to Pfizer for us to look at. The patient wife thinks that he was having an affair on her because of this. The patient had to go to get Comirnaty because it was not offered in that country. Patient wants to know could Pfizer tell his wife that this is a side effect of the vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: Had an allergic reaction; Itch; Hives; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 60 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "Ulcerative (chronic) pancolitis without complications" (unspecified if ongoing); "Primary generalized (Osteo)arthritis" (unspecified if ongoing); "Idiopathic urticaria" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Humira, reaction(s): "Allergy", notes: Verbatim: allergy: HUMIRA. The patient's concomitant medications were not reported. Past drug history included: Humira, reaction(s): "Allergy", notes: Verbatim: allergy: HUMIRA. The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Had an allergic reaction"; PRURITUS (non-serious), outcome "unknown", described as "Itch"; URTICARIA (non-serious), outcome "unknown", described as "Hives".  Additional information: She said she took xeljanz for 30 days, missed 3 weeks of medication. she was now out of remission. She said due to pharmacy switch. Counselled on missed doses. She said prescriber was aware. She was taking Xeljanz for ulcerative colitis. Not eligible for adherence program. She said she was previously on Humira, it was discontinued because she had an allergic reaction, itch and hives. She got first dose of the COVID vaccine around the same time, didn't mention a brand for the Covid vaccine. She mentions Humira helped with arthritis, believes it was osteoarthritis. She said her arthritis was hurting now. Patient mentions she gets a shot in her neck for arthritis, believes it was a steroid, but didn't know the name.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.