chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of vaccine products; Diagnosed with Covid-19; Diagnosed with Covid-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing), notes: Comments: Diabetic. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Mar2023, outcome "unknown" and all described as "Diagnosed with Covid-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". The event "diagnosed with covid-19" required emergency room visit. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: There was no prior vaccinations (within 4 weeks) and no family medical history relevant to adverse events. Had total of 3 or 4 vaccines, 1 was Monderna, did not have dates, NDC, LOT, EXP for these vaccines with her at this time. Has information on vaccine card. Felt like they got everything, got really sick. Was sicker than a dog. Her husband, not so much. Caller declines to complete report on husband, stating everything was the same except for the degree of illness. Fully vaccinated, got primary series, boosters and, got Covid-19. Clarified that caller was diagnosed with Covid prior to taking the Paxlovid. Were both taking some meds, were told to stop taking one while on Paxlovid.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300145996 Same product and event, different patient;
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: interchange of vaccine products; Diagnosed with Covid-19; Diagnosed with Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), 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. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset 27Mar2023, outcome "unknown" and all described as "Diagnosed with Covid-19"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The caller reporting they were fully vaccinated, got primary series, boosters and, got Covid-19. They were treated with Paxlovid.Were both taking some meds, were told to stop taking one while on Paxlovid. Felt like they got everything, got really sick. Was sicker than a dog. Her husband, not so much. The caller declined to complete report on husband, stating everything was the same except for the degree of illness.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300145993 Same product and event, different patient;
Age: 59.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A 59-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Oct2022 as dose 5 (booster), single (Lot number: GJ6665) at the age of 59 years, in left arm for covid-19 immunisation; covid-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing); "Dry Eyes" (unspecified if ongoing); "Pork allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146024 Same patient, different drug, different event;
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: broke out; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for Covid-19 immunization, reaction(s): "broke out". The following information was reported: RASH (non-serious), outcome "unknown", described as "broke out".  Additional information: Patient took Pfizer COVID vaccine and "broke out" with some type of reaction. She got the first two, but she don't want the other one. She had a problem with the first two. She broke out for five months. Doctor had the Pfizer vaccine, got that one without any problem. Patient's husband had vaccine he didn't have no problem. People in the family that's allergic to Penicillin.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300063751 Same patient/event, same vaccine but different doses;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: I had a case of COVID; I had a case of COVID; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "I had a case of COVID". The event "i had a case of covid" required physician office visit. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: The doctor recommended Paxlovid for treatment of COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146282 same patient, different drug/event;
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 08Oct2022 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 38 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 11Mar2021 as dose 1, single (Batch/Lot number: unknown), in right arm, on 01Apr2021 as dose 2, single (Batch/Lot number: unknown), in right arm and on 23Apr2022 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), on 09Oct2021 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Eosinophilic esophagitis" (unspecified if ongoing); "Anxiety" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Oxycodone, reaction(s): "Drug allergy"; Hydrocodone, reaction(s): "Drug allergy". The following information was reported: COVID-19 (medically significant) with onset 22Mar2023, outcome "not recovered"; DRUG INEFFECTIVE (medically significant) with onset 22Mar2023, outcome "not recovered". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (22Mar2023) Positive; (27Mar2023) Negative; (01Apr2023) Positive; (05Apr2023) Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received treatment with Paxlovid from 22Mar2023 till 27Mar2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146806 same patient different drug/events.;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Visual impairment
Clinical narrative: little bit sore arm; little bit of the vision problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 1, 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: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "little bit sore arm"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "little bit of the vision problem".  Additional Information: It was reported that all the Pfizer COVID Vaccines up until the patient had the third one. The patient had the usual, little bit sore arm and a little bit of that. Little bit of the vision problem with printing kind of small. It was kind of hard to read the card.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146030 Same patient/drug/ different dose/event;US-PFIZER INC-202300147023 Same patient/drug/ different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Visual impairment
Clinical narrative: Little bit sore arm; Little bit of vision problem; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162b2 (BNT162B2), as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, Single), for Covid-19 immunization, reaction(s): "Little bit sore arm", "Little bit of the vision problem". The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Little bit sore arm"; VISUAL IMPAIRMENT (non-serious), outcome "unknown", described as "Little bit of vision problem".  Additional Information: It was reported that all the Pfizer COVID Vaccines up until the patient had the third one. The patient had the usual, little bit sore arm and a little bit of that. Little bit of the vision problem with printing kind of small. It was kind of hard to read the card.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146030 same patient/product, different dose/events;US-PFIZER INC-202300146971 same patient/product, different dose/events;
Sex: U
Vaccine: COVID19
Symptoms: Dysstasia, Sleep disorder
Clinical narrative: Problem with standing up and going to sleep while standing; problem with standing up and going to sleep while standing; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2 (BNT162B2 NOS), 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: DYSSTASIA (non-serious), outcome "unknown", described as "Problem with standing up and going to sleep while standing"; SLEEP DISORDER (non-serious), outcome "unknown", described as "problem with standing up and going to sleep while standing".  Additional information: Reporter had a friend who also had a problem with standing up and going to sleep while standing.     The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146105 same reporter and product, different patient and event;US-PFIZER INC-202300147134 same reporter and product, different patient and event;US-PFIZER INC-202300147135 same reporter and product, different patient and event;US-PFIZER INC-202300147136 same reporter and product, different patient and event;US-PFIZER INC-202300147137 same reporter and product, different patient and event;
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Drug ineffective; Suspected COVID-19; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: DRUG INEFFECTIVE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown".Clinical course: It was reported that her HCP said, he and his wife both took two shots and ended out with the virus. Clarified she doesn't know what the name of the two shots her HCP and his wife took. Clarified she has no product information to provide. Clarified her HCP and his wife had it two times after getting the shots. Further clarified she does not know what product her HCP or the HCP's wife took.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146105 Different patient/same product, different dose/event;US-PFIZER INC-202300147048 Different patient/same product, different dose/event;US-PFIZER INC-202300147135 Different patient/same product, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Her HCP said he and his wife both took two shots and ended out with the virus/doesn't know that the name of the two shots/had it two times after getting the shots; Her HCP said he and his wife both took two shots and ended out with the virus/doesn't know that the name of the two shots/had it two times after getting the shots; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (COVID-19 VACCINE NOS MANUFACTURER UNKNOWN), 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "Her HCP said he and his wife both took two shots and ended out with the virus/doesn't know that the name of the two shots/had it two times after getting the shots".  Clinical course: It was reported that the reporter's HCP said he and his wife both took two shots and ended out with the virus. Clarified she doesn't know what the name of the two shots her HCP and his wife took. Knows lots of people who had the shots and ended out with the virus. Clarified she has no patient information to provide or product information to provide. Clarified she may have information on her cousin she could find out about. Her cousin had taken a shot and got the virus. A lot of other people took it and had it. Clarified her HCP and his wife had it two times after getting the shots. Further clarified she does not know what product the other people, her cousin, her HCP, or the HCP's wife took. She took the booster in the early part of 2021 and had it before she went back to work.   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300147134 Different patient/same product, different dose/event;
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Drug ineffective; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female 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 included: "High cholesterol" (unspecified if ongoing); "Diabetes" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), outcome "unknown"; COVID-19 (medically significant), outcome "unknown". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: A young woman in the office did have the vaccine and, she got COVID-19, now has long COVID. She is dying to pieces right now.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300147060 same reporter, different drug/pt; Report 3 of 3;US-PFIZER INC-PV202300064867 same patient and product, different dose and event;US-PFIZER INC-PV202300064904 same patient and product, different dose and event;
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Bronchospasm, Dyspnoea, Fatigue, Feeling abnormal, Insomnia
Clinical narrative: bronchospasm; shortness of breath; brain fog; difficulty sleeping at night; extreme exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 52-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Dec2022 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) (PREVNAR 20), in Dec2022 as single dose (Batch/Lot number: unknown) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: BRONCHOSPASM (non-serious), 10 days after the suspect product(s) administration, outcome "recovering"; DYSPNOEA (non-serious), 10 days after the suspect product(s) administration, outcome "recovering", described as "shortness of breath"; FEELING ABNORMAL (non-serious), 10 days after the suspect product(s) administration, outcome "recovering", described as "brain fog"; INSOMNIA (non-serious), 10 days after the suspect product(s) administration, outcome "recovering", described as "difficulty sleeping at night"; FATIGUE (non-serious), 10 days after the suspect product(s) administration, outcome "recovering", described as "extreme exhaustion". Additional information: The patient reported being very sick after receiving the 4th COVID 19 Booster vaccine Pfizer with variant and Prevnar 20 vaccine in Dec2022. After 10 days receiving the vaccine patient reported she begun experiencing the same symptoms as she did after receiving the COVID booster injection last time (unknown date.) These symptoms include "bronchospasm, shortness of breath, brain fog, difficulty sleeping at night, and extreme exhaustion," but they are improving. Per the doctor and patient indicated that the symptoms were reaction's to the "COVID booster". Therapy was currently on hold. The last dose of Lenvima 18mg capsules once a day was on Feb2023 (unknown exact date). Unknown when to resume therapy. No hospitalization. MD is aware.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, pneumococcal 20-valent conjugate vaccine (diphtheria CRM197 protein) has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2
Symptoms: Dizziness, Vertigo
Clinical narrative: Dizzy; Everything was spinning around like 100 miles per hour or may be about 102; 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 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 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 completed, unknown manufacturer), for COVID-19 Immunization.  The following information was reported: DIZZINESS (non-serious) with onset Apr2023, outcome "unknown", described as "Dizzy"; VERTIGO (non-serious) with onset Apr2023, outcome "unknown", described as "Everything was spinning around like 100 miles per hour or may be about 102".  Additional information: It was stated that, "Yeah this afternoon, the patient got booster shot, Pfizer booster shot in afternoon maybe almost 8 hours ago. Earlier may be like 15-20 minutes ago felt dizzy. Everything was spinning around like 100 miles per hour or may be about 102". Stated, "That was a long time".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Interchange of vaccine product; Drug ineffective; COVID-19; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): MOD-2023-718100 (Moderna).  A 49-year-old male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), 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. The following information was reported: COVID-19 (medically significant) with onset Sep2022, outcome "unknown"; DRUG INEFFECTIVE (medically significant) with onset Sep2022, outcome "unknown"; INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "Interchange of vaccine product". Clinical course: Patient has received one Moderna booster (date received unknown) and described a side effect of fever with the Moderna booster that "lasted slightly longer" than any side effects experienced with their Pfizer vaccine doses. The fever experienced following their Moderna booster was described as mild and subsided within a half day. Respondent also had been infected with Covid (Sep2022). Experience of symptoms with Covid also described as mild, limited mostly to fever and cough.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Drug ineffective depends on many factors including severity of disease and patient general health condition. However on conservative basis, the possible causality cannot be excluded.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Electroencephalogram, Hypoaesthesia, Illness, Magnetic resonance imaging head
Clinical narrative: felt sick; fever; body aches; chills; numbness of bilateral distal arms and legs (forearms/hands & shins/feet); This is a spontaneous report received from contactable reporter(s) (Physician).  A 25-year-old male patient received BNT162b2 (BNT162B2), on 07Mar2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing), notes: Patient has prior Hx of possible Multiple Sclerosis; "abnormal imaging" (unspecified if ongoing), notes: Brain MRI showing some abnormal imaging 5 yrs ago; "abnormal EEG" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious) with onset 20Mar2023, outcome "recovering", described as "numbness of bilateral distal arms and legs (forearms/hands & shins/feet)"; ILLNESS (non-serious), outcome "recovered", described as "felt sick"; PYREXIA (non-serious), outcome "recovered", described as "fever"; PAIN (non-serious), outcome "recovered", described as "body aches"; CHILLS (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received his first COVID-19 vaccine 07Mar2023 and 13 days later developed severe numbness of bilateral distal arms and legs (forearms/hands & shins/feet) which dramatically improved after 10 days when he received his 2nd COVID-19 vaccination on 30Mar2023. He then only had very mild residual tingling numbness. Did have side effects and felt sick from both shots with fever, body aches, and chills lasting 24 hrs along with some nausea with 2nd vaccination. No imaging or other tests have been done yet but plans to see his Neurologist in follow up. Optional Information patient has prior Hx of possible Multiple Sclerosis with Brain MRI showing some abnormal imaging 5 yrs ago but has been stable since. Also has Hx of prior abnormal EEG. His only current medication is Omeprazole for acid reflux. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300145275 same patient/SD, different AE/dose;
Sex: M
Vaccine: COVID19
Symptoms: Pain, Pyrexia
Clinical narrative: felt sick; fever; body aches; chills; numbness of bilateral distal arms and legs (forearms/hands & shins/feet); This is a spontaneous report received from contactable reporter(s) (Physician).  A 25-year-old male patient received BNT162b2 (BNT162B2), on 07Mar2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Multiple Sclerosis" (unspecified if ongoing), notes: Patient has prior Hx of possible Multiple Sclerosis; "abnormal imaging" (unspecified if ongoing), notes: Brain MRI showing some abnormal imaging 5 yrs ago; "abnormal EEG" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: HYPOAESTHESIA (non-serious) with onset 20Mar2023, outcome "recovering", described as "numbness of bilateral distal arms and legs (forearms/hands & shins/feet)"; ILLNESS (non-serious), outcome "recovered", described as "felt sick"; PYREXIA (non-serious), outcome "recovered", described as "fever"; PAIN (non-serious), outcome "recovered", described as "body aches"; CHILLS (non-serious), outcome "recovered". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient received his first COVID-19 vaccine 07Mar2023 and 13 days later developed severe numbness of bilateral distal arms and legs (forearms/hands & shins/feet) which dramatically improved after 10 days when he received his 2nd COVID-19 vaccination on 30Mar2023. He then only had very mild residual tingling numbness. Did have side effects and felt sick from both shots with fever, body aches, and chills lasting 24 hrs along with some nausea with 2nd vaccination. No imaging or other tests have been done yet but plans to see his Neurologist in follow up. Optional Information patient has prior Hx of possible Multiple Sclerosis with Brain MRI showing some abnormal imaging 5 yrs ago but has been stable since. Also has Hx of prior abnormal EEG. His only current medication is Omeprazole for acid reflux. Event took place after use of product.  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300145275 same patient/SD, different AE/dose;
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: hand issues like swelling and pain; hand issues like swelling and pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Covid-19" (unspecified if ongoing), notes: covid-19 three times and had long cold symptoms . The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "unknown" and all described as "hand issues like swelling and pain."  Additional information: The reporter had queried on behalf of someone that he tried to help with some of their medical stuff. He said he was not a doctor. He mentioned that someone had covid-19 three times and had long cold symptoms and the bivalent helped them to get rid of the symptoms. He said he suggested that to that person but after they took the bivalent six months or five months later, they got covid again and that person has hand issues like swelling and pain. He wanted to know if they could take the bivalent booster for the second time. Also, the reporter had a query about Paxlovid. He wanted to know if you could take that after you have covid.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300148557 Same patient, samedrug, different event (split);
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Drug ineffective; Suspected COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), 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: DRUG INEFFECTIVE (medically significant), outcome "unknown"; SUSPECTED COVID-19 (medically significant), outcome "unknown". Clinical Course: It was reported that the patient was fully vaccinated. Patient got COVID, everybody at their house had COVID.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: broke out; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A female patient received BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: RASH (non-serious), outcome "unknown", described as "broke out".  Additional information: Patient reported that she got the first two, but she does not want the other one. She had a problem with the first two and broke out for five months. She had both, she had the Pfizer.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300146370 Same patient/event, same vaccine but different doses;
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Asthma, Auditory disorder, Condition aggravated
Clinical narrative: Insomnia; Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker); Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker); Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker); Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker); Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker); morning nausea; lost sense of smell; taste loss/sense of taste loss; metallic taste; vertigo; Tinnitus; dizzy; extreme (3x normal) hearing in right ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-718503 (Moderna).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 24Aug2021 as dose 1, single (Lot number: fc3183) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "childhood asthmatic" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "Smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 24Aug2021, outcome "recovering"; DIZZINESS (non-serious) with onset 24Aug2021, outcome "recovering", described as "dizzy"; AUDITORY DISORDER (non-serious) with onset 24Aug2021, outcome "recovering", described as "extreme (3x normal) hearing in right ear"; ANOSMIA (non-serious) with onset 27Aug2021, outcome "recovering", described as "lost sense of smell"; DYSGEUSIA (non-serious) with onset 27Aug2021, outcome "recovering", described as "metallic taste"; NAUSEA (non-serious) with onset 27Aug2021, outcome "recovering", described as "morning nausea"; AGEUSIA (non-serious) with onset 27Aug2021, outcome "recovering", described as "taste loss/sense of taste loss"; VERTIGO (non-serious) with onset 27Aug2021, outcome "recovering"; INSOMNIA (non-serious), outcome "recovering"; ASTHMA (non-serious), OBESITY (non-serious), HYPERTENSION (non-serious), TOBACCO USER (non-serious), CONDITION AGGRAVATED (non-serious), outcome "recovering" and all described as "Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker)". Additional information: Long-term effects to Pfizer/BioNTech - 10 mins after receiving Pfizer vaccine 1st dose, 24Aug2021, tinnitus, dizzy, extreme (3x normal) hearing in right ear. On the third morning (27Aug2021) nausea, lost sense of smell, sense of taste loss as well, metallic taste, vertigo. Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker). 20Feb2023 started training 1 hr daily and is helping with recovery.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Dysgeusia, Hypertension, Insomnia, Nausea
Clinical narrative: Insomnia; Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker); Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker); Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker); Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker); Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker); morning nausea; lost sense of smell; taste loss/sense of taste loss; metallic taste; vertigo; Tinnitus; dizzy; extreme (3x normal) hearing in right ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-718503 (Moderna).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 24Aug2021 as dose 1, single (Lot number: fc3183) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "childhood asthmatic" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "Smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 24Aug2021, outcome "recovering"; DIZZINESS (non-serious) with onset 24Aug2021, outcome "recovering", described as "dizzy"; AUDITORY DISORDER (non-serious) with onset 24Aug2021, outcome "recovering", described as "extreme (3x normal) hearing in right ear"; ANOSMIA (non-serious) with onset 27Aug2021, outcome "recovering", described as "lost sense of smell"; DYSGEUSIA (non-serious) with onset 27Aug2021, outcome "recovering", described as "metallic taste"; NAUSEA (non-serious) with onset 27Aug2021, outcome "recovering", described as "morning nausea"; AGEUSIA (non-serious) with onset 27Aug2021, outcome "recovering", described as "taste loss/sense of taste loss"; VERTIGO (non-serious) with onset 27Aug2021, outcome "recovering"; INSOMNIA (non-serious), outcome "recovering"; ASTHMA (non-serious), OBESITY (non-serious), HYPERTENSION (non-serious), TOBACCO USER (non-serious), CONDITION AGGRAVATED (non-serious), outcome "recovering" and all described as "Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker)". Additional information: Long-term effects to Pfizer/BioNTech - 10 mins after receiving Pfizer vaccine 1st dose, 24Aug2021, tinnitus, dizzy, extreme (3x normal) hearing in right ear. On the third morning (27Aug2021) nausea, lost sense of smell, sense of taste loss as well, metallic taste, vertigo. Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker). 20Feb2023 started training 1 hr daily and is helping with recovery.
Age: 58.0
Sex: M
Vaccine: COVID19
Symptoms: Obesity, Tinnitus, Tobacco user, Vertigo
Clinical narrative: Insomnia; Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker); Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker); Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker); Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker); Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker); morning nausea; lost sense of smell; taste loss/sense of taste loss; metallic taste; vertigo; Tinnitus; dizzy; extreme (3x normal) hearing in right ear; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): MOD-2023-718503 (Moderna).  A 58-year-old male patient received BNT162b2 (BNT162B2), on 24Aug2021 as dose 1, single (Lot number: fc3183) at the age of 58 years for covid-19 immunisation. The patient's relevant medical history included: "childhood asthmatic" (unspecified if ongoing); "Obesity" (unspecified if ongoing); "Blood pressure high" (unspecified if ongoing); "Smoker" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: TINNITUS (non-serious) with onset 24Aug2021, outcome "recovering"; DIZZINESS (non-serious) with onset 24Aug2021, outcome "recovering", described as "dizzy"; AUDITORY DISORDER (non-serious) with onset 24Aug2021, outcome "recovering", described as "extreme (3x normal) hearing in right ear"; ANOSMIA (non-serious) with onset 27Aug2021, outcome "recovering", described as "lost sense of smell"; DYSGEUSIA (non-serious) with onset 27Aug2021, outcome "recovering", described as "metallic taste"; NAUSEA (non-serious) with onset 27Aug2021, outcome "recovering", described as "morning nausea"; AGEUSIA (non-serious) with onset 27Aug2021, outcome "recovering", described as "taste loss/sense of taste loss"; VERTIGO (non-serious) with onset 27Aug2021, outcome "recovering"; INSOMNIA (non-serious), outcome "recovering"; ASTHMA (non-serious), OBESITY (non-serious), HYPERTENSION (non-serious), TOBACCO USER (non-serious), CONDITION AGGRAVATED (non-serious), outcome "recovering" and all described as "Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker)". Additional information: Long-term effects to Pfizer/BioNTech - 10 mins after receiving Pfizer vaccine 1st dose, 24Aug2021, tinnitus, dizzy, extreme (3x normal) hearing in right ear. On the third morning (27Aug2021) nausea, lost sense of smell, sense of taste loss as well, metallic taste, vertigo. Insomnia is accelerating symptoms (childhood asthmatic, obese, history of hbp, smoker). 20Feb2023 started training 1 hr daily and is helping with recovery.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: painful injection: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP), Program ID: The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), 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: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "painful injection".  Additional information: Age group was reported as Adult (18 to less than 65 years). Pfizer product name: Comirnaty.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: Vaccines don't work; Suspected COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP), Program ID: (RA). The reporter is the patient.  An adult female patient received BNT162b2 (BNT162B2 NOS), 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: DRUG INEFFECTIVE (medically significant), outcome "unknown", described as "Drug ineffective/ Vaccines don't work"; SUSPECTED COVID-19 (medically significant), outcome "unknown".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Heart rate, Heart rate abnormal, Wheelchair user
Clinical narrative: had an average resting heartbeat of 90 beats per minute; was wheelchair bound for four months; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received COVID-19 Vaccine - Manufacturer Unknown, 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: HEART RATE ABNORMAL (non-serious), outcome "unknown", described as "had an average resting heartbeat of 90 beats per minute"; WHEELCHAIR USER (non-serious), outcome "unknown", described as "was wheelchair bound for four months". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient was not clear in whether the AE was from the Moderna or Pfizer vaccine.  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: TDAP
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: A patient received an early dose of Adacel yesterday with no reported AE; Initial information was received on 04-Apr-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 28 years old female patient who experienced a patient received an early dose of adacel yesterday with no reported ae while receiving vaccine diphtheria-2/tetanus/5 ac pertussis vaccine [Adacel].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 03-Apr-2023, the patient received a dose of suspect diphtheria-2/tetanus/5 ac pertussis vaccine Suspension for injection at dose of 0.5 ml lot U7657AA ( route, strength, expiry date; unknown) in the left deltoid for Immunization.  On 03-Apr-2023 the patient developed a non-serious event of a patient received an early dose of adacel yesterday with no reported ae (inappropriate schedule of product administration) following the administration of diphtheria-2/tetanus/5 ac pertussis vaccine.  It was reported "A patient received an early dose of Adacel yesterday, 03Apr2021. The dose was administered in the left deltoid. A factor in the error is that the administering nurse looked at the Td vaccine in the system and saw that the last date of the Td vaccine for the patient was in 2007. The nurse did not see that the patient received a Tdap on 22Jun2021. She went by the last dose of Td and incorrectly thought the patient was due for Tdap".  Action taken with DIPHTHERIA, TETANUS and acellular pertussis vaccine (Adacel) was not applicable.  At time of reporting, the outcome was Unknown for the event a patient received an early dose of adacel yesterday with no reported ae.  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.