chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Overdose, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: fever; The reporter was under the impression that patient received covid 19 gray cap, monovalent instead of the omicron booster vaccine. pharmacy was adamant that her daughters received the correct vaccine; The reporter was under the impression that patient received covid 19 gray cap, monovalent instead of the omicron booster vaccine. pharmacy was adamant that her daughters received the correct vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 9-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 as dose 4 (booster), single (Lot number: GJ3275) 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: PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (non-serious), OVERDOSE (non-serious) all with onset 18Oct2022, outcome "unknown" and all described as "The reporter was under the impression that patient received covid 19 gray cap, monovalent instead of the omicron booster vaccine. pharmacy was adamant that her daughters received the correct vaccine"; PYREXIA (non-serious), outcome "unknown", described as "fever".  Additional Information: The reporter was under the impression her daughters, 9-year-old and 8-year-old daughters received covid 19 gray cap, monovalent instead of the omicron booster vaccine. She called the pharmacy, and the pharmacy was adamant that her daughters received the correct vaccine and asked what vaccine was this, based on Lot number recorded. Reporter stated that reporter's daughter received the monovalent Covid-19 vaccine as their booster dose. Patient was supposed to have been receiving the Bivalent booster dose (lot number: GJ3275). Reporter didn't think it was the new Omicron booster that her daughters received and didn't know if it was the pediatric dose or what. Her daughters were having side effects, but they had side effects with the other vaccines as well, so she's not really worried about that. But, when she found out they didn't get the right booster dose, it made her concerned. Pharmacy insisted that her daughters received the bivalent booster vaccine yesterday (18Oct2022). Reporter asked if someone can look up the lot number and tell her which vaccine that LOT was for. She trusted Pfizer over the pharmacy, so she wants to check the lot number first.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201243364 same reporter/ drug/ event for different patients;
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose, Blood glucose decreased, Dyspnoea, Loss of personal independence in daily activities
Clinical narrative: when I take a walk I would get real winded/ I am breathing harder; I felt like my blood sugar was dropping; I am panicking; almost could not get home that happened 3 or 4 times; I got weak; I am not feeling good; This is a spontaneous report received from a 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: DYSPNOEA (non-serious), outcome "unknown", described as "when I take a walk I would get real winded/ I am breathing harder"; BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "I felt like my blood sugar was dropping"; PANIC DISORDER (non-serious), outcome "unknown", described as "I am panicking"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "almost could not get home that happened 3 or 4 times"; ASTHENIA (non-serious), outcome "unknown", described as "I got weak"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling good". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient has been hearing on the news and some of the people, patient cousin says they do not know what's wrong with her, has something to do with the valve but they do not what it was and the other person today said it has to do with one of his heart valves. So, patient panicked and wondering if the Pfizer test if that was the side effect, if people were starting to have breathing problems and if it has done damage to hearts and do not know if your lab have that.  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-202201244654 same reporter/drug/event, different patients.;
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Panic disorder
Clinical narrative: when I take a walk I would get real winded/ I am breathing harder; I felt like my blood sugar was dropping; I am panicking; almost could not get home that happened 3 or 4 times; I got weak; I am not feeling good; This is a spontaneous report received from a 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: DYSPNOEA (non-serious), outcome "unknown", described as "when I take a walk I would get real winded/ I am breathing harder"; BLOOD GLUCOSE DECREASED (non-serious), outcome "unknown", described as "I felt like my blood sugar was dropping"; PANIC DISORDER (non-serious), outcome "unknown", described as "I am panicking"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious), outcome "unknown", described as "almost could not get home that happened 3 or 4 times"; ASTHENIA (non-serious), outcome "unknown", described as "I got weak"; MALAISE (non-serious), outcome "unknown", described as "I am not feeling good". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The patient has been hearing on the news and some of the people, patient cousin says they do not know what's wrong with her, has something to do with the valve but they do not what it was and the other person today said it has to do with one of his heart valves. So, patient panicked and wondering if the Pfizer test if that was the side effect, if people were starting to have breathing problems and if it has done damage to hearts and do not know if your lab have that.  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-202201244654 same reporter/drug/event, different patients.;
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood glucose decreased, Dyspnoea, Flatulence, Malaise
Clinical narrative: when I take a walk I would get real winded, sometimes I felt like my blood sugar was dropping, I got weak and almost could not get home that happened 3 or 4 times; when I take a walk I would get real winded, sometimes I felt like my blood sugar was dropping, I got weak and almost could not get home that happened 3 or 4 times; when I take a walk I would get real winded, sometimes I felt like my blood sugar was dropping, I got weak and almost could not get home that happened 3 or 4 times; I am breathing harder; I am weak and I am not feeling good; I am panicking; 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) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FLATULENCE (non-serious), BLOOD GLUCOSE DECREASED (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "when I take a walk I would get real winded, sometimes I felt like my blood sugar was dropping, I got weak and almost could not get home that happened 3 or 4 times"; DYSPNOEA (non-serious), outcome "unknown", described as "I am breathing harder"; MALAISE (non-serious), outcome "unknown", described as "I am weak and I am not feeling good"; PANIC DISORDER (non-serious), outcome "unknown", described as "I am panicking".  Additional information: It was reported that the patient had been complaining to the doctors since Mar and finally got fed up and saw another doctor yesterday and they ordered an EKG and they send him to for an echocardiogram. Well, his cousin was having same symptoms and she was waiting to see a cardiologist and he met two people today, one who said her brother was having the same symptoms. They had been hearing on the news and some of the people he talk, his cousin says they do not know what's wrong with her, has something to do with the valve but they do not what it is. And the other person today said it has to do with one of his heart valve. So I had panicking and wondering if the Pfizer test if that was the side effect, if people were starting to had breathing problems and if it had done damage to hearts and he do not know if our lab have that.  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-202201244654 same reporter/drug/event, different patients.;
Sex: M
Vaccine: COVID19
Symptoms: Panic disorder
Clinical narrative: when I take a walk I would get real winded, sometimes I felt like my blood sugar was dropping, I got weak and almost could not get home that happened 3 or 4 times; when I take a walk I would get real winded, sometimes I felt like my blood sugar was dropping, I got weak and almost could not get home that happened 3 or 4 times; when I take a walk I would get real winded, sometimes I felt like my blood sugar was dropping, I got weak and almost could not get home that happened 3 or 4 times; I am breathing harder; I am weak and I am not feeling good; I am panicking; 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) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FLATULENCE (non-serious), BLOOD GLUCOSE DECREASED (non-serious), ASTHENIA (non-serious), outcome "unknown" and all described as "when I take a walk I would get real winded, sometimes I felt like my blood sugar was dropping, I got weak and almost could not get home that happened 3 or 4 times"; DYSPNOEA (non-serious), outcome "unknown", described as "I am breathing harder"; MALAISE (non-serious), outcome "unknown", described as "I am weak and I am not feeling good"; PANIC DISORDER (non-serious), outcome "unknown", described as "I am panicking".  Additional information: It was reported that the patient had been complaining to the doctors since Mar and finally got fed up and saw another doctor yesterday and they ordered an EKG and they send him to for an echocardiogram. Well, his cousin was having same symptoms and she was waiting to see a cardiologist and he met two people today, one who said her brother was having the same symptoms. They had been hearing on the news and some of the people he talk, his cousin says they do not know what's wrong with her, has something to do with the valve but they do not what it is. And the other person today said it has to do with one of his heart valve. So I had panicking and wondering if the Pfizer test if that was the side effect, if people were starting to had breathing problems and if it had done damage to hearts and he do not know if our lab have that.  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-202201244654 same reporter/drug/event, different patients.;
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Sore throat, lasted less than 6 hr; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 18Oct2022 at 14:15 as dose 5 (booster), single (Lot number: GJ6742) at the age of 55 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Nuts allergy" (unspecified if ongoing); "Shellfish allergy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 2, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 3, Manufacturer: Unknown), for COVID-19 immunization; Covid-19 vaccine (Dose: 4, Manufacturer: Unknown), for COVID-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 19Oct2022 at 12:00, outcome "recovered" (19Oct2022), described as "Sore throat, lasted less than 6 hr". Therapeutic measures were not taken as a result of oropharyngeal pain.  Additional Information: It was reported that patient did not received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and Since the vaccination. Device date was reported as 20Oct2022.  No follow-up attempts are possible. No further information is expected.
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Vomiting
Clinical narrative: Following morning woke up with headache and excessive vomiting; Following morning woke up with headache and excessive vomiting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 12-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 at 16:15 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 12 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, patient was diagnosed with COVID-19. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 2; Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (Dose 3; Manufacturer unknown), for COVID-19 immunization. The following information was reported: VOMITING (non-serious), HEADACHE (non-serious) all with onset 20Oct2022 at 07:15, outcome "unknown" and all described as "Following morning woke up with headache and excessive vomiting". Therapeutic measures were not taken as a result of vomiting, headache.  Additional information: Patient had no known allergies. Patient was not tested COVID post vaccination.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Mild Nausea; This is a spontaneous report received from non-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), on 19Oct2022 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 MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, SINGLE MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 3 (BOOSTER), SINGLE MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: NAUSEA (non-serious) with onset 19Oct2022, outcome "unknown", described as "Mild Nausea". It was unknown if therapeutic measures were taken as a result of nausea.  Additional Information-It was unknown if patient received any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination. Since the vaccination, patient had not been tested for COVID-19.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Body height, Crying, Decreased appetite, Feeling abnormal, Headache
Clinical narrative: headache; sleeping every day; start to lose appetite; he goes sleep with it and wakes up with it annoying for him it can't sleep in the middle of the night it bothers him; he cries for like hours; it's been really weird, like 6-7 months/ he's like in a fog; losing weight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  An 18-year-old male patient received BNT162b2 (BNT162B2), 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 series of immunization completed unknown manufacturer.), for covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "not recovered"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleeping every day"; DECREASED APPETITE (non-serious), outcome "unknown", described as "start to lose appetite"; SLEEP DISORDER (non-serious), outcome "unknown", described as "he goes sleep with it and wakes up with it annoying for him it can't sleep in the middle of the night it bothers him"; CRYING (non-serious), outcome "unknown", described as "he cries for like hours"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it's been really weird, like 6-7 months/ he's like in a fog"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "losing weight". The event "headache" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter reported that His son received the Pfizer covid-19 booster (not the new one bivalent/omicron, not verified if purple or gray) on June or May and experienced headache. He was sleeping every day, start to lose appetite, not eating. His headache continues as he goes sleep with it and wakes up with it annoying for him it can't sleep in the middle of the night it bothers him, he cries for like hours. it's been really weird, like 6-7 months, he's like in a fog (unverified, sounds like) you talked to him it's like he not even here. The headaches started after the vaccine, but they thought it would go away. Patient has been going to the doctors and he is still having it, the headaches have been going on for 6-7 months. He was crying every day.  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: Sleep disorder, Somnolence, Weight decreased
Clinical narrative: headache; sleeping every day; start to lose appetite; he goes sleep with it and wakes up with it annoying for him it can't sleep in the middle of the night it bothers him; he cries for like hours; it's been really weird, like 6-7 months/ he's like in a fog; losing weight; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  An 18-year-old male patient received BNT162b2 (BNT162B2), 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 series of immunization completed unknown manufacturer.), for covid-19 immunization. The following information was reported: HEADACHE (non-serious), outcome "not recovered"; SOMNOLENCE (non-serious), outcome "unknown", described as "sleeping every day"; DECREASED APPETITE (non-serious), outcome "unknown", described as "start to lose appetite"; SLEEP DISORDER (non-serious), outcome "unknown", described as "he goes sleep with it and wakes up with it annoying for him it can't sleep in the middle of the night it bothers him"; CRYING (non-serious), outcome "unknown", described as "he cries for like hours"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "it's been really weird, like 6-7 months/ he's like in a fog"; WEIGHT DECREASED (non-serious), outcome "unknown", described as "losing weight". The event "headache" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Reporter reported that His son received the Pfizer covid-19 booster (not the new one bivalent/omicron, not verified if purple or gray) on June or May and experienced headache. He was sleeping every day, start to lose appetite, not eating. His headache continues as he goes sleep with it and wakes up with it annoying for him it can't sleep in the middle of the night it bothers him, he cries for like hours. it's been really weird, like 6-7 months, he's like in a fog (unverified, sounds like) you talked to him it's like he not even here. The headaches started after the vaccine, but they thought it would go away. Patient has been going to the doctors and he is still having it, the headaches have been going on for 6-7 months. He was crying every day.  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: Influenza like illness, Malaise
Clinical narrative: had a flu like/sick feeling for 3 days; sick feeling for 3 days, didn't feel 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.  A 76-year-old 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: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "had a flu like/sick feeling for 3 days"; MALAISE (non-serious), outcome "unknown", described as "sick feeling for 3 days, didn't feel well". Additional information: It was reported patient received the primary series and one booster shot from Pfizer. Patient had two covid shot and had one booster back in Mar from her local Pharmacy. Patient wanted to know more about the Pfizer Bivalent vaccine and stated that she went to the pharmacist and was told there is another booster dose. She had side effects with the first two covid vaccines and 1 booster. She had a flu like/sick feeling for 3 days. Patient clarified that she was not allergic to the previous vaccine doses but 7-8 hours later she didn't feel well and a couple of days later. 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, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Oct2022 at 09:15 as dose 5 (booster), single (Batch/Lot number: unknown), 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: "sarcoidosis" (unspecified if ongoing); "COPD" (unspecified if ongoing). The patient took concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: tested positive again; Positive, notes: indication=Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient received other medication in 2 weeks.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Costochondritis, Lymphadenopathy, Menstrual disorder, Swelling
Clinical narrative: chest pain that she describes as severe, constant, in the breast tissue, hard to move, hard to pick things up, hurt constantly; chest swelling; monthly cycles have been very effected and are still 'pretty bad'.; chest swelling that her doctor thought might be relayed to lymph node issues and under her arm lymph nodes; chest swelling that her doctor thought might be relayed to lymph node issues and under her arm lymph nodes; 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 34-year-old female patient received BNT162b2 (BNT162B2), on 07Dec2021 as dose 3 (booster), single (Lot number: FH8027) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 01, Lot number: unknown), administration date: Apr2021, for COVID-19 immunization, reaction(s): "chest pain that she describes as severe, constant, in the breast tissue, hard to move, hard to pick things up, hurt constantly", "chest swelling might be relayed to lymph node issues and under her arm lymph nodes", "monthly cycles have been very effected and are still 'pretty bad'", "chest swelling might be relayed to lymph node issues and under her arm lymph nodes"; Bnt162b2 (DOSE: 02, Lot number: unknown), administration date: May2021, for COVID-19 immunization, reaction(s): "chest pain that she describes as severe, constant, in the breast tissue, hard to move, hard to pick things up, hurt constantly", "chest swelling might be relayed to lymph node issues and under her arm lymph nodes", "monthly cycles have been very effected and are still 'pretty bad'", "chest swelling might be relayed to lymph node issues and under her arm lymph nodes". The following information was reported: CHEST PAIN (medically significant), outcome "unknown", described as "chest pain that she describes as severe, constant, in the breast tissue, hard to move, hard to pick things up, hurt constantly"; COSTOCHONDRITIS (non-serious), outcome "unknown", described as "chest swelling"; MENSTRUAL DISORDER (non-serious), outcome "unknown", described as "monthly cycles have been very effected and are still 'pretty bad'."; SWELLING (non-serious), LYMPHADENOPATHY (non-serious), outcome "unknown" and all described as "chest swelling that her doctor thought might be relayed to lymph node issues and under her arm lymph nodes".
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Rash
Clinical narrative: Rash; heart issues; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 65-year-old 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. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series completed; Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: RASH (non-serious), outcome "unknown"; CARDIAC DISORDER (non-serious), outcome "unknown", described as "heart issues". The event "rash" required physician office visit.  Additional information: Clarified she was not 100% sure if it was Pfizer, it could have been Moderna or Pfizer, she just heard it was the bivalent covid vaccine. She overheard someone talked about the adverse event at the grocery store. She does not know the name or any contact details of the reporter. The person at the grocery store mentioned that a 65-year-old patient developed a rash, and then went to the doctor and now that patient has heart issues supposedly. She does not know what number dose this was for the patient. She does not have any patient details to provide except the age. Confirms she had no further information to provide. The same person at the grocery store also mentioned a pharmacist that vaccinates patients with covid vaccines, that got cancer. The pharmacist thought the cancer was due to vaccinating patients and not wearing gloves. Unknown gender or any patient details for pharmacist, therefore additional report not created. Caller does not know the manufacturer this pharmacist was using to vaccinate patients with the covid vaccine, manufacturer was not specified. Unknown product details. No lot, ndc, or expiration date to provide. Confirms she has no further information to provide.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunodeficiency
Clinical narrative: immunocompromised; 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 parent.  A 12-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 1, single (Batch/Lot number: unknown) and in 2021 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: IMMUNODEFICIENCY (medically significant), outcome "unknown", described as "immunocompromised".  Clinical Course: Patient took Comirnaty, Pfizer-BioNTech COVID-19 Vaccine [Monovalent] and/or Bivalent, Gray cap, Original (Monovalent), greater than or equal to 12 years - 30 mcg/dose, do not dilute. Caller was calling for her daughter 12-year-old in primary series a year ago and now he would like to know which vaccine she should get for the booster dose since she was immunosuppressed. Confirmed above information with caller. Caller was a caregiver that states his 12-year-old daughter was immunocompromised. The caller stated she completed a primary series a year ago and that this primary series consisted of two doses only, not three. Caller requests information on which vaccine should be indicated to her daughter, if the monovalent third primary series or the bivalent booster. Caller was a caregiver that requests the differences between the Pfizer-BioNTech COVID-19 vaccine for 12 years and older (gray cap) and the Pfizer-BioNTech COVID-19 vaccine, Bivalent (Original and Omicron BA.4/BA.5) booster dose for 12 years of age and older (gray cap). Caller was a caregiver that asks whether the Pfizer-BioNTech COVID-19 vaccine, Bivalent (Original and Omicron BA.4/BA.5) booster dose for 12 years of age and older (gray cap) would be more effective than the Pfizer-BioNTech COVID-19 vaccine for 12 years and older (gray cap) in protecting her daughter who was immunocompromised and only received a primary series of two doses instead of three.  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: COVID-19, Drug ineffective
Clinical narrative: had covid before/her previous covid vaccines were of Pfizer's; had covid before/her previous covid vaccines were of Pfizer's; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team and product quality group. The reporter is the patient.  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: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2022, outcome "unknown" and all described as "had covid before/her previous covid vaccines were of Pfizer's". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: Patient was currently taking Xeljanz and was thinking of getting the flu shot and the bivalent covid vaccine. She mentioned that she had covid before and was taking Paxlovid for it. She added that she took her last dose of Paxlovid in the morning of 30Jul2022. She also added that her previous covid vaccines were of (withheld). She is wondering how long does she need to wait to get the bivalent vaccine after having covid. Caller also asked as follow-up, since she took Paxlovid during her covid infection, she wanted to know if how long she should also wait before getting the bivalent vaccine if her last dose was on 30Jul2022.  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: Cough, Nausea, Vomiting
Clinical narrative: coughing; nauseous; throwing up; 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 69-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (unspecified if ongoing); "COPD" (unspecified if ongoing); "COVID" (unspecified if ongoing), notes: She had COVID and was in a hospital for almost 2 weeks. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary immunization series completed (MANUFACTURER UNKNOWN)), for COVID-19 immunization. The following information was reported: COUGH (non-serious), outcome "unknown", described as "coughing"; NAUSEA (non-serious), outcome "unknown", described as "nauseous"; VOMITING (non-serious), outcome "unknown", described as "throwing up".  Additional information: She mentioned that she was diabetic and had COPD. She also mentioned that she had COVID and was in a hospital for almost 2 weeks. The reporter had the Bivalent vaccine (Gray cap, Original/Omicron BA.4/BA.5 (Bivalent), greater than and equal to 12 years, 15/15 mcg per dose) yesterday and experienced adverse reaction, she was nauseous, coughing and throwing up. She wanted to know if that was normal and know if these were reported side effects from the vaccine. Hence reporter asked if the symptoms she had could be caused by the vaccine or by the infection of COVID that she had. The case was reported as Non-serious.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma
Clinical narrative: The caller stated his wife has asthma. She has had all the Pfizer COVID shots; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 63-year-old female patient received BNT162b2 (BNT162B2), 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) at the age of 63 years for covid-19 immunisation. The patient's relevant medical history included: "weak immune system" (unspecified if ongoing), notes: he stated they have always thought she had a weak immune system. The patient's concomitant medications were not reported. The following information was reported: ASTHMA (non-serious), outcome "unknown", described as "The caller stated his wife has asthma. She has had all the Pfizer COVID shots". Therapeutic measures were taken as a result of asthma.  Additional information: Patient had asthma. Patient received all the doses of the vaccine and the reporter wanted to know if his wife can get the booster dose since his wife was taking Fasenra injection every month. He wanted to know if there was waiting time before taking the new booster dose. She had all the Pfizer COVID shots, the original two Pfizer COVID vaccines and two boosters, and was about to go in for the BA4/BA5 variants, Pfizer BioNTech COVID-19 Bivalent adult booster (gray cap). She also took an injection every other month for asthma, Fasenra and had the last one last Sunday. He wanted to know if there is a period of time she should wait after that injection before getting the COVID booster. They called AstraZeneca since they make that product to check on it for that product. After providing information about immunocompetence he stated they have always thought she had a weak immune system but did not know that she has ever been officially diagnosed as immunocompromised and not on any medication for that condition (altered immunocompetence). She did not had another appointment planned with her doctor for a couple months. His HCP recommended he get the flu shot first, which he did in her office yesterday and then wait two weeks before getting the COVID vaccine. He was not sure why their recommendations would be different than CDC recommendations and wanted to know Pfizer's stance.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Interchange of vaccine products, Rash, Rash papular
Clinical narrative: here was a rash around her neck that feels like fire ants; it started it was burning red bumps, little teeny, tiny red bumps; it's burning; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 74-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Oct2022 as dose 5 (booster), single (Lot number: GJ2524) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid-19 vaccine (Primary immunization series completed), for COVID-19 immunization; Moderna covid-19 vaccine (Dose 3 (Booster)), for COVID-19 immunization; Moderna covid-19 vaccine (Dose 4 (Booster)), for COVID-19 immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 19Oct2022, outcome "unknown"; RASH (non-serious) with onset 20Oct2022, outcome "unknown", described as "here was a rash around her neck that feels like fire ants"; RASH PAPULAR (non-serious) with onset 20Oct2022, outcome "unknown", described as "it started it was burning red bumps, little teeny, tiny red bumps"; BURNING SENSATION (non-serious) with onset 20Oct2022, outcome "unknown", described as "it's burning".  Additional information: Patient stated that, She had the "biochrome" formulation of the Pfizer BioNTech Covid 19 vaccine as a booster. (She could not 100% confirm that it was the new omicron bivalent gray cap booster). She was noticed there was a rash around her neck that feels like fire ants. Before she had two primary doses of the Moderna Covid 19 vaccine and then two boosters of the Moderna. Her physician told her it didn't matter if she could mix and match the booster and she got the Pfizer one because all they had was Pfizer. This was her third booster. She was just wondering how to got rid of it. She noticed it this morning, when it started it was burning red bumps, little teeny, tiny red bumps. She only had the rash, no other symptoms; no swelling of the throat or difficulty breathing. With the Moderna vaccines she had no side effects, she had nothing with the other ones.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: Had a flu like/sick feeling for 3 days; Had a flu like/sick feeling for 3 days/Didn't feel well; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A 76-year-old 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, Had a flu like/sick feeling for 3 days), for COVID-19 immunisation, reaction(s): "Had a flu like/sick feeling", "Had a flu like/sick feeling"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunisation, reaction(s): "Didn't feel well". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Had a flu like/sick feeling for 3 days"; MALAISE (non-serious), outcome "recovered", described as "Had a flu like/sick feeling for 3 days/Didn't feel well".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Malaise
Clinical narrative: Had a flu like/sick feeling for 3 days; Had a flu like/sick feeling for 3 days/ Didn't feel well; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A 76-year-old female patient received BNT162b2 (BNT162B2), in Mar2022 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. Vaccination history included: Bnt162b2 (DOSE 1), for COVID-19 Immunization, reaction(s): "Had a flu like/sick feeling for 3 days", "Feeling unwell", "Had a flu like/sick feeling for 3 days"; Bnt162b2 (DOSE 2), for COVID-19 Immunization, reaction(s): "Had a flu like/sick feeling for 3 days", "Didn't feel well", "Had a flu like/sick feeling for 3 days". The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "recovered", described as "Had a flu like/sick feeling for 3 days"; MALAISE (non-serious), outcome "unknown", described as "Had a flu like/sick feeling for 3 days/ Didn't feel well".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: her right leg turns purple due to her heart; her right leg turns purple due to her heart; affected it kidneys and heart after getting Omicron; affected it kidneys and heart after getting Omicron; She felt like passing out; wanted to sleep and sleep and sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 44-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "EDS" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: CONTUSION (hospitalization), CARDIAC DISORDER (hospitalization), outcome "unknown" and all described as "her right leg turns purple due to her heart"; RENAL DISORDER (hospitalization), CARDIAC DISORDER (hospitalization), outcome "unknown" and all described as "affected it kidneys and heart after getting Omicron"; LOSS OF CONSCIOUSNESS (medically significant), outcome "unknown", described as "She felt like passing out"; SOMNOLENCE (non-serious), outcome "unknown", described as "wanted to sleep and sleep and sleep". The patient underwent the following laboratory tests and procedures: Blood test: put a damper on her heart and kidneys, notes: Omicron put a damper on her heart and kidneys that showed up on bloodwork. Therapeutic measures were taken as a result of contusion, cardiac disorder.  Clinical course: During the report caller stated that the patient had a lot of problems. The patient had kidney and heart problems and having 4 kids. The patient got Omicron variety and had gotten all her shots except the 2nd booster. Omicron put a damper on patient's heart and kidneys that showed up on bloodwork. The reporter originally called and asked why it would bother her kidneys so bad, it made her hurt more. The patient had the Pfizer Covid 19 vaccines but not the last one because they told her to wait. The reporter did not know if it was because she got Covid. The patient had so much built up and she had Omicron really bad. The patient felt like passing out and wanted to sleep and sleep and sleep. The patient's right leg turns purple due to her heart, and they did blood work. The patient went to the hospital when she had Covid and the tests found it was affecting her heart and kidneys and showed damage to both heart and kidneys. Caller does not have Pfizer Covid 19 vaccine details to include dates, NDC, lot or expiry but she reported those previously.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201246575 same patient, different vaccine dose/events;
Sex: F
Vaccine: COVID19
Symptoms: Blood immunoglobulin M, Blood immunoglobulin M increased, Coagulopathy
Clinical narrative: coagulation; IgM was at 94.5; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP and Other HCP). Other Case identifier(s): 2022NVX-US-000003731.  A female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: BNT162b2 (Dose 1), administration date: 14Mar2021, for Covid-19 immunization; Bnt162b2 (Dose 2, after the first series the IgM went to 58), for Covid-19 immunization, reaction(s): "IgM went to 58"; Bnt162b2 (Dose 3 (Booster)), for Covid-19 immunization. The following information was reported: COAGULOPATHY (non-serious), outcome "unknown", described as "coagulation"; BLOOD IMMUNOGLOBULIN M INCREASED (non-serious), outcome "unknown", described as "IgM was at 94.5". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: On 05Oct2022, it was reported that a patient started treatment on 14Mar2021 with Pfizer BioNTech Covid-19 vaccine at an unspecified dose/frequency for Covid-19 immunization. It was reported the patient experienced the following: after the first series the IgM went to 58, and after the 4th booster the IgM was at 94.5 and they reported it should be around 10. They reported the mRNA was causing coagulation.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.