chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Pain, Vaccination site discolouration, Vaccination site pain
Clinical narrative: intense headache; body aches; nausea; black, blue, tender at injection site; black, blue, tender at injection site; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient received BNT162b2 (BNT162B2), on 11Apr2022 at 14:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: sulpha" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization completed but manufacturer unknown), for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), VACCINATION SITE DISCOLOURATION (non-serious) all with onset 11Apr2022, outcome "recovering" and all described as "black, blue, tender at injection site"; PAIN (non-serious) with onset 11Apr2022, outcome "recovering", described as "body aches"; HEADACHE (non-serious) with onset 11Apr2022, outcome "recovering", described as "intense headache"; NAUSEA (non-serious) with onset 11Apr2022, outcome "recovering". Therapeutic measures were taken as a result of headache, pain, nausea, vaccination site pain, vaccination site discolouration.  Additional information: Facility type vaccine was pharmacy or Drug Store. There was no other vaccine in four weeks. There adverse event treatment was Tylenol. There was no covid prior vaccination. There was no covid tested post vaccination. Known allergies was sulpha.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Vaccination site pain
Clinical narrative: tiredness; Soreness at injection site; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 58-year-old female patient received BNT162b2 (BNT162B2), in Apr2022 as dose 4 (booster), single (Lot number: FM0698) at the age of 58 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Allergic to Sulfa drug" (unspecified if ongoing), notes: Allergic to Sulfa drug. Concomitant medication(s) included: ATORVASTATIN; LEVOTHYROXINE; CALCIUM WITH VITAMIN D [CALCIUM CARBONATE;COLECALCIFEROL]; FIBER THERAPY. Past drug history included: Aspirin, reaction(s): "Aspirin: Drug allergy". Vaccination history included: Bnt162b2 (Dose 3, Batch/Lot number: FT8762, Location of injection/shot: Left arm, Route of administration: Intramuscular), administration date: Dec2021, when the patient was 58 years old, for Covid-19 immunization; Bnt162b2 (Dose 2, Batch/Lot number: EP6955, Location of injection/shot: Left arm, Route of administration: Intramuscular), administration date: Apr2021, when the patient was 57 years old, for Covid-19 immunization; Bnt162b2 (Dose 1, Batch/Lot number: EP6955, Location of injection/shot: Left arm, Route of administration: Intramuscular), administration date: Mar2021, when the patient was 57 years old, for Covid-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 11Apr2022 at 19:30, outcome "recovering", described as "Soreness at injection site"; FATIGUE (non-serious) with onset 12Apr2022 at 16:30, outcome "recovering", described as "tiredness". Therapeutic measures were taken as a result of vaccination site pain, fatigue.  Additional information:Adverse event information: Adverse event date: 11Apr2022.Adverse event time: 07:30 PM. The patient Treatment  received with ice applied at injection site and Tylenol.Prior to vaccination, the patient was not diagnosed with Covid-19.Since the vaccination, the patient has not been tested for covid-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Cough, Gastrooesophageal reflux disease
Clinical narrative: cough sometimes feels like a "gerd cough"; Prolonged Cough/Dry Cough; This is a spontaneous report received from contactable reporter(s) (Other HCP and Consumer or other non HCP), Program ID.  A 55-year-old male patient received BNT162b2 (BNT162B2), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; tofacitinib citrate (XELJANZ XR), since 01May2020. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series complete, MANUFACTURER: UNKNOWN, ), for Covid-19 Immunization. The following information was reported: COUGH (non-serious) with onset 2021, outcome "unknown", described as "Prolonged Cough/Dry Cough"; GASTROOESOPHAGEAL REFLUX DISEASE (non-serious), outcome "unknown", described as "cough sometimes feels like a "gerd cough"". The action taken for tofacitinib citrate was unknown. Therapeutic measures were not taken as a result of cough, gastrooesophageal reflux disease.  Additional information: Patient reports adverse event of prolonged cough. Symptoms include: dry cough since Oct2021/Nov2021. Patient unsure if it was due to COVID booster that he got. Patient had spoken with his doctor and has an appointment later this week. 3 months ago patient was on z-pack from the cough as he had yellow mucus as an additional symptom from the cough. Patient stated cough sometimes feels like a "gerd cough". Patient had not tried any OTC meds for relief.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 13.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Pharyngitis, Viral infection
Clinical narrative: Acute pharyngitis; Viral syndrome; Asthma; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 14-year-old female patient received BNT162b2 (BNT162B2), on 24Jun2021 as dose 2, single (Lot number: EW0181) at the age of 13 years for covid-19 immunisation. The patient's relevant medical history included: "GERD", start date: 19Mar2020 (ongoing). The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose: 01, Batch number: EW015), administration date: 02Jun2021, when the patient was 13-year-old, for COVID-19 Immunization. The following information was reported: ASTHMA (non-serious) with onset 23Dec2021, outcome "not recovered"; VIRAL INFECTION (non-serious) with onset 25Feb2022, outcome "recovered" (28Feb2022), described as "Viral syndrome"; PHARYNGITIS (non-serious) with onset 01Mar2022, outcome "recovered" (16Mar2022), described as "Acute pharyngitis". Additional information Prior vaccinations were none. Concomitant drugs were Unknown. Relevant tests were none. Specific relevant test for thromboembolic events with thrombocytopenia was none. Patient age at the time of vaccination was 14 Years. Dose details: 03 Date/Time: 24Mar2022 15:08 Site and Route of injection Anatomical site of injection: Left Arm Route of administration: Intramuscular Batch number: FK9729. Comments/Narrative: Grey top Covid 0.3mI dose given after expiration (refrigeration date of 10 weeks. Accidentally went with the expiration date entered MCIR thinking it was still good after 10-week Storage. was informed that was the manufacturer expiration date and the 10-week date is still Correct There has been no side effects or concerns from patient of parents.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Aphonia, Swelling
Clinical narrative: Loss of voice; major swelling under left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FL3197, Expiration Date: 30Jun2022) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:3, Expiration date: 31Mar2022, Lot no.: FF2589), for Covid-19 Immunization, reaction(s): "Dizzy", "Change of voice", "Dose received: 3", "lymphadenopathy", "Swelling under right armpit"; Bnt162b2 (Dose:2, Expiration date: May2021, Lot no.: EL3247), for Covid-19 Immunization, reaction(s): "loss of voice", "lymphadenopathy", "fever", "swelling under her right armpit"; Bnt162b2 (Dose:1, Expiration date: May2021, Lot no.: EL3247), for Covid-19 Immunization, reaction(s): "right clavicle pain", "right clavicle was swollen", "soreness of her right arm".  The following information was reported: SWELLING (non-serious) with onset 09Apr2022, outcome "recovered" (11Apr2022), described as "major swelling under left arm"; APHONIA (non-serious) with onset 11Apr2022, outcome "not recovered", described as "Loss of voice". Therapeutic measures were not taken as a result of aphonia, swelling.  Additional information: Stated that this was after her fourth dose. that there was a loss of voice. Previously reported that her right clavicle was swollen, right clavicle pain and soreness of her right arm for the first dose. Stated that she reported previously that she had swelling under her right armpit with the second dose. Stated that she reported previously that she had swelling under right armpit and loss of voice and referenced that she thought she reported it also with the second dose. For your forth dose, event major swelling under left arm" reported with start ate was 09Apr2022. But this report L7VU8YZ5 was submitted on 12Apr2022. The awareness date for the swelling was April 9 and submitted along with the Voice issue.  No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Loss of voice; major swelling under left arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), on 08Apr2022 as dose 4 (booster), single (Lot number: FL3197, Expiration Date: 30Jun2022) at the age of 52 years, in left arm for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose:3, Expiration date: 31Mar2022, Lot no.: FF2589), for Covid-19 Immunization, reaction(s): "Dizzy", "Change of voice", "Dose received: 3", "lymphadenopathy", "Swelling under right armpit"; Bnt162b2 (Dose:2, Expiration date: May2021, Lot no.: EL3247), for Covid-19 Immunization, reaction(s): "loss of voice", "lymphadenopathy", "fever", "swelling under her right armpit"; Bnt162b2 (Dose:1, Expiration date: May2021, Lot no.: EL3247), for Covid-19 Immunization, reaction(s): "right clavicle pain", "right clavicle was swollen", "soreness of her right arm".  The following information was reported: SWELLING (non-serious) with onset 09Apr2022, outcome "recovered" (11Apr2022), described as "major swelling under left arm"; APHONIA (non-serious) with onset 11Apr2022, outcome "not recovered", described as "Loss of voice". Therapeutic measures were not taken as a result of aphonia, swelling.  Additional information: Stated that this was after her fourth dose. that there was a loss of voice. Previously reported that her right clavicle was swollen, right clavicle pain and soreness of her right arm for the first dose. Stated that she reported previously that she had swelling under her right armpit with the second dose. Stated that she reported previously that she had swelling under right armpit and loss of voice and referenced that she thought she reported it also with the second dose. For your forth dose, event major swelling under left arm" reported with start ate was 09Apr2022. But this report L7VU8YZ5 was submitted on 12Apr2022. The awareness date for the swelling was April 9 and submitted along with the Voice issue.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Erythema
Clinical narrative: had redness on his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown), in arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: ERYTHEMA (non-serious), outcome "unknown", described as "had redness on his arm".  Additional information: Caller stated she was calling about the Pfizer vaccine for coronavirus and stated they had a little bit of confusion and she called her husband's internist office and inquired whether or not he should get the 2nd booster vaccine and the last one he had was his 2nd booster and that was in September; stated she asked because the patient had an appointment with his endocrinologist so she called the endocrinologist because he has two physicians and the endocrinologist called her back and said the patient could wait for the 2nd booster dose or until there was a surge to get the 2nd booster or he could get it now. Caller stated she heard what the endocrinologist said and that HCP managed the patient's health and the internist's office got back to her yesterday and said that yes the patient should go ahead and get the 2nd booster now and because there was a surge now and the question they have also was when the office got back to her and said the patient should request the new FDA approved vaccine, she was not sure and the patient called his pharmacy this morning and she wanted to ascertain does someone have a new vaccine out for the 2nd booster as it was approved by the EUA and now the FDA; caller clarified the patient has not gotten the 2nd booster vaccine yet. Caller awared that Pfizer unable to offer medical advice or treatment recommendations. Caller stated her husband also said he had redness on his arm after the vaccine and she told him well everyone has redness on their arm. Caller stated she would have to go get the vaccine cards as it was not with her at this time and asked if she could do the reports online at a later time.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Bone pain, Bone swelling, Pain in extremity
Clinical narrative: right clavicle was swollen; right clavicle pain; soreness of her right arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52-year-old female patient received BNT162b2 (BNT162B2), as dose 1, single (Lot number: EL3247) for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: BONE SWELLING (non-serious), outcome "unknown", described as "right clavicle was swollen"; BONE PAIN (non-serious), outcome "unknown", described as "right clavicle pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "soreness of her right arm".  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: under arm lymph node swelling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), on 14Jan2021 at 11:30 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "under arm lymph node swelling".  Clinical course- The patient experienced under arm lymph node swelling after 1st vaccine and booster and had a mammogram, 3 breast exams, and an ultrasound 5 months after booster. All proved nothing, but under arm still felt swollen enough to bother day and night. Now 6 months after booster, feeling was gone.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy
Clinical narrative: Bells Palsy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 20May2021 as dose 2, single (Lot number: EWO171) at the age of 28 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). There were no concomitant medications. The patient didn't received other vaccine in four weeks. The patient didn't received other medications in two weeks. Vaccination history included: BNT162b2 (dose 1, single, lot number: EWO153, vaccine location: Left arm), administration date: 29Apr2021, when the patient was 28-year-old, for Covid-19 immunization. The following information was reported: BELL'S PALSY (medically significant) with onset Oct2021, outcome "recovering", described as "Bells Palsy". The event "bells palsy" required physician office visit and emergency room visit. Therapeutic measures (Steroids medication) were taken as a result of bell's palsy. The patient visited the urgent care in Oct2021 following sudden loss of feeling/ drooping of right side of face. The patient got diagnosed with Bells Palsy on 09Oct2021 and was still dealing with the fallout/ effects of healing from it. The patient didn't test Covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Back pain, Intervertebral disc protrusion
Clinical narrative: back pain; herniated disc; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown"; INTERVERTEBRAL DISC PROTRUSION (non-serious), outcome "unknown", described as "herniated disc".  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Intervertebral disc protrusion
Clinical narrative: back pain; herniated disc; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BACK PAIN (non-serious), outcome "unknown"; INTERVERTEBRAL DISC PROTRUSION (non-serious), outcome "unknown", described as "herniated disc".  The lot number for the vaccine, BNT162B2, was not provided and will be requested during follow-up
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding
Clinical narrative: extra heavy periods; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "extra heavy periods".  Additional Information: Male patient himself does not want to be contacted about this by Pfizer. He shared that he experienced back pain and herniated disc after Pfizer COVID vaccine and his wife had extra heavy periods after her COVID vaccine. Yes this happened after Pfizer vaccine Pfizer COVID vaccine   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Dyspepsia, Endoscopy, Hot flush, Oesophageal pain
Clinical narrative: flares of heat in odd spots on body, mostly chest and upper back, sometomes in face, sometimes the bottom of feet; severe burning in esophagus and into stomach; severe burning in esophagus and into stomach; chest pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient (unknown if pregnant) received BNT162b2 (BNT162B2), on 15Dec2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete;  unknown manufacturer), for Covid-19 immunization. The following information was reported: CHEST PAIN (non-serious) with onset 17Dec2021, outcome "unknown"; OESOPHAGEAL PAIN (non-serious), DYSPEPSIA (non-serious) all with onset 19Dec2021, outcome "unknown" and all described as "severe burning in esophagus and into stomach"; HOT FLUSH (non-serious), outcome "unknown", described as "flares of heat in odd spots on body, mostly chest and upper back, sometomes in face, sometimes the bottom of feet". The events "flaresm of heat in odd spots on body, mostly chest and upper back, sometomes in face, sometimes the bottom of feet" required physician office visit. The events "chest pain" and "severe burning in esophagus and into stomach" required physician office visit and emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: No one could figure out what had happened to the patient. She had seen a GI (gastrointestinal) and had an endoscopy.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Bladder spasm
Clinical narrative: severe lower back pain; spasm like bladder spasm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) (patient's child).  An 86-year-old female patient received BNT162b2 (BNT162B2), on 12Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, single), for COVID-19 Immunization; Covid-19 vaccine (dose 2, single), for COVID-19 Immunization; Covid-19 vaccine (dose 3, single), for COVID-19 Immunization. The following information was reported: BACK PAIN (non-serious) with onset Apr2022, outcome "unknown", described as "severe lower back pain"; BLADDER SPASM (non-serious) with onset Apr2022, outcome "unknown", described as "spasm like bladder spasm". Additional information: the reporter was taking care of the patient.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID: The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2 (BNT162B2), in Nov2021 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; Unknown manufacturer), for COVID-19 immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "pain at the injection site".  Additional information included: Customer Verbatim: I received my booster shot in Nov2021 and still have pain at the injection site. I don't believe 5 months would be considered normal. I am trying to find the right doctor to assess, but wanted to reach out to first inform of this side effect and to see if you may offer some guidance.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Hypoacusis
Clinical narrative: Also he seems not to hear completely well; 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.  An adult male patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HYPOACUSIS (non-serious), outcome "unknown", described as "Also he seems not to hear completely well". The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested COVID positive; tested COVID positive; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative.  A 55-year-old male patient (weight was lean to average) received BNT162b2 (COMIRNATY), in Feb2021 as dose 1 single (Batch/Lot number: unknown), in Mar2021 as dose 2, single (Batch/Lot number: unknown) and in Sep2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: COVID-19 (medically significant), DRUG INEFFECTIVE (medically significant) all with onset 11Apr2022, outcome "unknown" and all described as "tested COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (11Apr2022) Positive. Symptoms were mild and did not require hospitalization. The patient traveled very frequently.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Migraine, Pain, Vaccination site pain
Clinical narrative: Felt sore at site in the morning; gradually got more body soreness; got a migraine headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 58-year-old female patient received BNT162b2 (BNT162B2), on 11Apr2022 at 18:00 as dose 4 (booster), single (Lot number: FK9894) at the age of 58 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (dose number: 3, lot number: Ff2590, administrator route: Intramuscular, administration date: 08Oct2021, vaccine location: Left arm), administration date: 08Oct2021, when the patient was 58-year-old, for Covid-19 immunization; Covid-19 vaccine (Dose 2, Manufacturer Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose 1, Manufacturer Unknown), for Covid-19 immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 12Apr2022, outcome "recovering", described as "Felt sore at site in the morning"; MIGRAINE (non-serious) with onset 12Apr2022, outcome "recovered" (Apr2022), described as "got a migraine headache"; PAIN (non-serious) with onset 12Apr2022, outcome "recovered" (Apr2022), described as "gradually got more body soreness". Therapeutic measures were not taken as a result of vaccination site pain. Therapeutic measures were taken as a result of pain, migraine.  Additional information: If covid prior vaccination: No. If covid tested post vaccination: No. Got vaccine at 6PM on 11Apr2022. Felt sore at site in the morning of 12Apr2022, gradually got more body soreness and took Advil at 10AM with good results. At 5PM soreness gradually came back and got a migraine headache. Took Advil at 8PM and slept through the night. Only experiencing site soreness on morning of 13Apr2202 and went to work.   No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Vaccination site injury
Clinical narrative: that is causing her daughter issues with her college; had trouble with the second vaccine/ second vaccine hit her daughter pretty hard; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 18-year-old female patient received BNT162b2 (BNT162B2), on 17Jul2021 as dose 2, single (Lot number: EW175) at the age of 18 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (Dose 1, Lot Number: EW175), administration date: 22Jun2021, when the patient was 17-year-old, for Covid-19 immunization.  The following information was reported: VACCINATION SITE INJURY (non-serious) with onset 17Jul2021, outcome "unknown", described as "had trouble with the second vaccine/ second vaccine hit her daughter pretty hard"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "that is causing her daughter issues with her college".  Additional Information: After reporting on her own events with the vaccine the caller provides information about her daughter. Caller states that her and her girls had their vaccines at the same time. States that her second daughter had trouble with the second vaccine and also does not want to get the booster. Caller states that is causing her daughter issues with her college. Caller states that the second vaccine hit her daughter pretty hard. Caller states that her daughter received her first dose of the vaccine on 22Jun2021; lot number reported and verified with the caller as being EW175. Caller states that her daughter's second dose of the vaccine was 17Jul2021 and states that it had the same lot number as her daughter's first dose; EW175.  No follow-up attempts are possible; No further information is expected.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Vaccination site pain
Clinical narrative: Chills; soreness at the injection site on left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58-year-old male patient received BNT162b2 (BNT162B2), on 30Oct2021 as dose 3 (booster), single (Lot number: FH8028, Expiration Date: 31May2022) at the age of 58 years, in left arm for covid-19 immunisation, prophylaxis. The patient's relevant medical history included: "High blood pressure" (ongoing), notes: About 20 years ago; "High Cholesterol" (ongoing), notes: About 20 years ago; "Sarcoidosis" (ongoing), notes: diagnosed maybe 12 years ago, Pertinent Details: He sees a respiratory therapist for this condition. There were no concomitant medications. Vaccination history included: BNT162b2 (First dose, Lot: E88732, Expiry: 31Jul2021, NDC: Unknown, not on the CDC vaccine record card., Dose: Unknown strength/volume/dose injection to he thinks left arm), administration date: 27Mar2021, when the patient was 57-year-old, for COVID-19 Immunization; BNT162b2 (Second dose, Lot: ER8731, Expiry: 31Jul2021, NDC: Unknown, not on the CDC vaccine record card., Dose: Unknown strength/volume/dose injection to he thinks left arm), administration date: 17Apr2021, when the patient was 57-year-old, for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Oct2021, outcome "recovered" (Nov2021), described as "soreness at the injection site on left arm"; CHILLS (non-serious), outcome "recovered".   Additional information: He also mentioned having chills and soreness at the injection site on left arm after his first booster shot of Pfizer Covid-19. There was no prior Vaccinations (within 4 weeks) If applicable, list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine(s). There was no AE(s) following prior vaccinations. Family Medical History Relevant to AE. Relevant Tests was none.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: MEN, MNQ
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: received a dose of menomune when he was 11 years old, then a second dose of menveo (non-sanofi product) one year after when he was 12 years old with no adverse event; Initial information received on 29-Mar-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 12-year-old male patient who received a dose of menomune when he was 11 years old, then a second dose of menveo (non-sanofi product) one year after when he was 12 years old with no adverse event after receiving meningococcal vaccine a/c/y/w conj (crm197) (Menveo) and meningococcal a-c-y-w135 vaccine [Menomune].   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a dose of suspect Menveo not produced by Sanofi Pasteur and received a dose of suspect Menomune lot number not reported via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date the patient developed a non-serious event as received a dose of menomune when he was 11 years old, then a second dose of menveo (non-sanofi product) one year after when he was 12 years old with no adverse event (inappropriate schedule of product administration) (unknown latency). The Caller stated that patient is now 16 years old and want to know if he needs a booster or not since he already received two doses.   Action taken was not applicable.  Outcome was Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: M
Vaccine: IPV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: given expired dose of IPOL vaccine with no reported adverse event; Initial information received on 05-Apr-2022 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 8 years old male patient who was given expired dose of ipol vaccine with no reported adverse event while receiving vaccine ipv (vero) [Ipol].     The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included measles vaccine, mumps vaccine, rubella vaccine (MMR) for Prophylactic vaccination.  On 05-Apr-2022, the patient received a  dose of 05.ml of suspect ipv (vero) formulation and strength unknown lot R1F972M via intramuscular route once in the left arm for Prophylactic vaccination.  On 05-APR-2022, same day, the patient was given expired dose of ipol vaccine with no reported adverse event (expired product administered). Site director is calling to ask for anything to watch out for in a pediatric patient who was given expired dose of IPOL vaccine. Site director mentioned that she knows that the vaccine should be repeated but wants to know any other details to provide to the parents and what to do moving forward.    Action taken: Not Applicable.  It was not reported if the patient received a corrective treatment for the event (given expired dose of IPOL vaccine with no reported adverse event).  At time of reporting, the outcome was Unknown for the event given expired dose of ipol vaccine with no reported adverse event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 0.17
Sex: M
Vaccine: DTAP
Symptoms: Crying
Clinical narrative: uncontrollable crying; Initial information received on 06-Apr-2022 regarding an unsolicited valid non-serious case received from other health care professional via call center.  This case involves a 2 months old male patient who experienced uncontrollable crying while receiving vaccine Diphtheria-15/Tetanus/5 AC pertussis vaccine [Daptacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 16-Jun-2021, the patient received a Dose 1, 0.5 ml total of suspect Diphtheria-15/Tetanus/5 AC pertussis vaccine (formulation, route: unknown) (lot C5765BA, expiry date unknown) via unknown route in unknown administration site for Immunization.  On an unknown date the patient developed a non-serious uncontrollable crying (crying) (unknown latency) following the administration of Diphtheria-15/Tetanus/5 AC pertussis vaccine.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (uncontrollable crying).  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event uncontrollable crying.
Age: 5.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Wrong product administered
Clinical narrative: administered a dose of PENTACEL instead of Kinrix to a 5 year old patient with no reported adverse event; Initial information received on 07-Apr-2022 regarding an unsolicited valid non-serious case received from other health professional.  This case involves a 5years old patient of unknown gender who was administered a dose of pentacel instead of kinrix to a 5 year old patient with no reported adverse event while receiving vaccine Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine [Pentacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received a dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine (formulation, strength, dose, route, indication, administration site, batch/lot number, expiration date: unknown).  On an unknown date, the patient was administered a dose of pentacel instead of kinrix to a 5 year old patient with no reported adverse event (wrong product administered) (unknown latency) following the administration of Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(MRC5)/HIB(PRP/T) Vaccine.  Action Taken: not applicable  At time of reporting, the outcome was Unknown for the event (wrong product administered).  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the guidelines. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 19.0
Sex: M
Vaccine: IPV
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: RN accidentally administered 1mL of IPOL in error instead of 0.5mL with no adverse event; Initial information received on 08-Apr-2022 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 19 years old male patient who experienced rn accidentally administered 1ml of ipol in error instead of 0.5ml with no adverse event after receiving vaccine IPV (VERO) (IPOL).   The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included YELLOW FEVER VACCINE LIVE (17D-204) (YF-VAX) for Prophylactic vaccination; TYPHOID VACCINE POLYSACCH VI (Typhim VI) for Prophylactic vaccination; and DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for Prophylactic vaccination.  On 08-Apr-2022, the patient received a dose of suspect IPV (VERO) at a dose of 1 ml with lot U1C571M via subcutaneous route in right arm for Immunization (incorrect dose administered) (latency: same day).  Reportedly she is asking if there is anything that they should do. She verifies that there are no adverse effects observed at the time.   Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (RN accidentally administered 1mL of IPOL in error instead of 0.5mL with no adverse event).  At time of reporting, the outcome was Unknown for the event rn accidentally administered 1ml of ipol in error instead of 0.5ml with no adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: DTAP
Symptoms: Medication error, No adverse event, Poor quality product administered, Product storage error
Clinical narrative: patient may have received a non-viable dose of DAPTACEL after the excursion with no reported adverse event; temperature excursion lasted for 80 hours and the highest temperature reached was 59.1F with no adverse event; Initial information received on 08-Apr-2022 regarding an unsolicited valid non-serious case received from a other health professional.   This case involves adult and unknown gender patient who may have received a non-viable dose of daptacel after the excursion with no reported adverse event and temperature excursion lasted for 80 hours and the highest temperature reached was 59.1f with no adverse event while receiving vaccine diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel].   The patient's past medical history, medical treatment(s), concomitant medication, vaccination(s) and family history were not provided.    On an unknown date, the patient received suspect diphtheria-15/tetanus/5 AC pertussis vaccine at an unknown dose (lot 5RM39, expiry date, strength, form) via unknown route in unknown administration site for immunisation.  On an unknown date the patient may have received a non-viable dose of daptacel after the excursion with no reported adverse event (poor quality product administered) and temperature excursion lasted for 80 hours and the highest temperature reached was 59.1f with no adverse event (product temperature excursion issue) (unknown latency) following the administration of diphtheria-15/tetanus/5 AC pertussis vaccine. Caller stated that the nurses were not pressing the reset button but this had been corrected. Caller does not have any information available at this time regarding the patient that potentially received daptacel after the excursion but can be contacted if additional information was needed.  Action taken: not applicable.  Corrective treatment: not reported.  Outcome was Unknown.    This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: It is reported as a medication error due to administration of the vaccine after expiry (with no adverse event); Initial information was received on 08-APR-2022 regarding an unsolicited valid non-serious case received from a non-health care professional via call center.   This case involves an unknown age and unknown gender patient who experienced it is reported as a medication error due to administration of the vaccine after expiry (with no adverse event) while receiving vaccine HIB (PRP/T) vaccine [ACT-HIB].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.    On an unknown date, the patient received a  dose of suspect HIB (PRP/T) vaccine (lot UJ357AAA and expiry- 26-JUL-2021) (strength, formulation, dose, route, batch number and expiry date: unknown) in unknown administration site for immunization.   On an unknown date the patient developed a non-serious "it is reported as a medication error due to administration of the vaccine after expiry (with no adverse event)" (expired product administered)  following the administration of HIB (PRP/T) vaccine. Action taken:  not applicable.  Action taken:  not applicable.  Outcome: unknown     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.