chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: DTPPVHBHPB
Symptoms: Product storage error
Clinical narrative: HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.; This spontaneous non -serious safety report, with reference number 02475849 (Interaction number 02475710) was received by a partner on 20-SEP-2023 and forwarded on 21-SEP-2023, from a HCP.  The causal relationship between Vaxelis and the reported event "HCP calling to report AE for VAXELIS PFS and ROTATEQ. Vaccines administered experienced a temperature excursion. No side effects reported.Temperature:8.74 C, Time frame:35min." was assessed as not applicable due to the nature of the event.  Further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Pain in extremity, Vaccination site pain
Clinical narrative: Interchange of vaccine products; On this injection it was a little sore for a couple of days but nothing like the last time/She had this injection and arm was sore for a couple of days, but not like the last time/Vaccination site pain; On this injection it was a little sore for a couple of days but nothing like the last time/She had this injection and arm was sore for a couple of days, but not like the last time/Pain in arm; 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 female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Lot number: HH7595) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (DOSE 3 (BOOSTER), SINGLE), administration date: 10May2022, for COVID-19 immunisation, reaction(s): "her first two Covid vaccines were the J&J", "she couldn't move her left arm at all/ her right arm was also extremely painful and could not move this one either", "her back was extremely painful and the pain radiated into right arm", "right arm was extremely painful and she couldn't move it either", "She had to stay in bed.", "injection it was a little sore for a couple of days"; Johnson and johnson covid vaccine (DOSE 1, SINGLE), for COVID-19 immunisation; Johnson and johnson covid vaccine (DOSE 2 (BOOSTER), SINGLE), for COVID-19 immunisation. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "On this injection it was a little sore for a couple of days but nothing like the last time/She had this injection and arm was sore for a couple of days, but not like the last time/Vaccination site pain"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "On this injection it was a little sore for a couple of days but nothing like the last time/She had this injection and arm was sore for a couple of days, but not like the last time/Pain in arm".  Additional information: She had the most recent Comirnaty 2023-2024 updated vaccine for adults, she did not provide the date received.  She had this injection and arm was sore for a couple of days, but not like the last time.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300305571 same patient, same product, different events (Dose 3);
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature increased, Headache, Neck pain, Pain
Clinical narrative: he got a "wicked" headache; He feels quite a bit of achy; joint achiness/a lot of achiness/pain in joints, both elbows, knee, neck.; joint achiness/a lot of achiness/pain in joints, both elbows, knee, neck.; Just had slightly elevated temperature; 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 64-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 7 (booster), single (Lot number: HG4629) intramuscular, in left deltoid for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: bnt162b2, bnt162b2 omi ba.4-5 (DOSE 5, NDC, lot, expiry: GJ6739, Time: 12:30PM, Anatomical Site of injection: Left arm), administration date: 07Oct2022, for COVID-19 immunization; bnt162b2, bnt162b2 omi ba.4-5 (DOSE 6, Pfizer bivalent, NDC, lot, expiry: GL0447, Time: 04:15PM, Anatomical Site of injection: Unknown), administration date: 27Jan2023, for COVID-19 immunization; Moderna covid vaccine (DOSE 1), administration date: Mar2021, for COVID-19 immunization; Moderna covid vaccine (DOSE 2), administration date: Apr2021, for COVID-19 immunization; Moderna covid vaccine (DOSE 3), administration date: Oct2021, for COVID-19 immunization; Moderna covid vaccine (DOSE 4), administration date: May2022, for COVID-19 immunization; Flu shot (Caller doesn't feel great/just feels yucky), reaction(s): "Caller doesn't feel great/just feels yucky"; Flu shot (classic achiness), reaction(s): "classic achiness/aching"; Flu shot, reaction(s): "a little bit of fever"; Flu shot (really doesn't feel like getting up and moving), reaction(s): "really doesn't feel like getting up and moving". The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset Sep2023, outcome "unknown", described as "Just had slightly elevated temperature"; PAIN (non-serious) with onset 20Sep2023, outcome "not recovered", described as "He feels quite a bit of achy"; HEADACHE (non-serious) with onset 20Sep2023, outcome "not recovered", described as "he got a "wicked" headache"; ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset 20Sep2023, outcome "not recovered" and all described as "joint achiness/a lot of achiness/pain in joints, both elbows, knee, neck.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pain, arthralgia, neck pain, body temperature increased.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: he got a "wicked" headache; He feels quite a bit of achy; joint achiness/a lot of achiness/pain in joints, both elbows, knee, neck.; joint achiness/a lot of achiness/pain in joints, both elbows, knee, neck.; Just had slightly elevated temperature; 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 64-year-old male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 7 (booster), single (Lot number: HG4629) intramuscular, in left deltoid for COVID-19 immunisation. The patient's relevant medical history was not reported. The patient took concomitant medications. Vaccination history included: bnt162b2, bnt162b2 omi ba.4-5 (DOSE 5, NDC, lot, expiry: GJ6739, Time: 12:30PM, Anatomical Site of injection: Left arm), administration date: 07Oct2022, for COVID-19 immunization; bnt162b2, bnt162b2 omi ba.4-5 (DOSE 6, Pfizer bivalent, NDC, lot, expiry: GL0447, Time: 04:15PM, Anatomical Site of injection: Unknown), administration date: 27Jan2023, for COVID-19 immunization; Moderna covid vaccine (DOSE 1), administration date: Mar2021, for COVID-19 immunization; Moderna covid vaccine (DOSE 2), administration date: Apr2021, for COVID-19 immunization; Moderna covid vaccine (DOSE 3), administration date: Oct2021, for COVID-19 immunization; Moderna covid vaccine (DOSE 4), administration date: May2022, for COVID-19 immunization; Flu shot (Caller doesn't feel great/just feels yucky), reaction(s): "Caller doesn't feel great/just feels yucky"; Flu shot (classic achiness), reaction(s): "classic achiness/aching"; Flu shot, reaction(s): "a little bit of fever"; Flu shot (really doesn't feel like getting up and moving), reaction(s): "really doesn't feel like getting up and moving". The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset Sep2023, outcome "unknown", described as "Just had slightly elevated temperature"; PAIN (non-serious) with onset 20Sep2023, outcome "not recovered", described as "He feels quite a bit of achy"; HEADACHE (non-serious) with onset 20Sep2023, outcome "not recovered", described as "he got a "wicked" headache"; ARTHRALGIA (non-serious), NECK PAIN (non-serious) all with onset 20Sep2023, outcome "not recovered" and all described as "joint achiness/a lot of achiness/pain in joints, both elbows, knee, neck.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of headache, pain, arthralgia, neck pain, body temperature increased.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.
Age: 29.0
Sex: F
Vaccine: COVID19, FLUC4
Symptoms: Cough, Epistaxis, Fatigue, Pain
Clinical narrative: body aches; fatigue; slight cough; bloody nose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 29-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 19Sep2023 at 07:15 as dose 1, single (Lot number: HF9275) at the age of 29 years intramuscular, in left arm for covid-19 immunisation; influenza vaccine inact sag 4v (FLUCELVAX QUAD), on 19Sep2023 as dose 1, single (Lot number: 944457), in right arm for influenza immunisation. The patient's relevant medical history included: "Sulfa" (unspecified if ongoing), notes: Sulfa based medication - Steven-Johnsons Syndrome as a result of allergy; "COVID-19", start date: 2022, stop date: 2022, notes: Treatment of COVID-19 with Paxlovid from 21Jun2022 to 26Jun2022. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 4 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: EPISTAXIS (non-serious) with onset Sep2023, 30 hrs after the suspect product(s) administration, outcome "recovered" (Sep2023), described as "bloody nose"; PAIN (non-serious) with onset 19Sep2023 at 21:00, outcome "recovered" (Sep2023), described as "body aches"; FATIGUE (non-serious) with onset 19Sep2023 at 21:00, outcome "recovered" (Sep2023); COUGH (non-serious) with onset 19Sep2023 at 21:00, outcome "recovered" (Sep2023), described as "slight cough". Therapeutic measures were not taken as a result of pain, fatigue, cough, epistaxis.  Additional information: Approximately 14 hours after receiving both the Flu and Covid Vaccines, patient experienced body aches and fatigue and a slight cough that lasted roughly 24 hours. Then 30 hours after vaccination, patient experienced a bloody nose. No treatment was received. The patient did not COVID tested post vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Fatigue, Headache, Inappropriate schedule of product administration
Clinical narrative: Swelling at injection site; temperature of 101.7; Bad Chills; Achy Muscles; Headache; Fatigue; Date of start of drug 21Sep2023 , dose number: 4/Date of start of drug 21Sep2023 , dose number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 64-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 01:45 as dose 4 (booster), single (Lot number: HF9275) at the age of 64 years intramuscular, in right arm for covid-19 immunisation; bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2023 as dose 3 (booster), single (Lot number: GJ6742), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergic to peaches, cashews" (unspecified if ongoing); "Allergic to silver and nickel" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, start date: 19Sep2023, stop date: 19Sep2023. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Sep2023, outcome "unknown", described as "Date of start of drug 21Sep2023 , dose number: 4/Date of start of drug 21Sep2023 , dose number: 3"; MYALGIA (non-serious) with onset 22Sep2023 at 12:45, outcome "not recovered", described as "Achy Muscles"; CHILLS (non-serious) with onset 22Sep2023 at 12:45, outcome "not recovered", described as "Bad Chills"; FATIGUE (non-serious) with onset 22Sep2023 at 12:45, outcome "not recovered"; HEADACHE (non-serious) with onset 22Sep2023 at 12:45, outcome "not recovered"; INJECTION SITE SWELLING (non-serious) with onset 22Sep2023 at 12:45, outcome "not recovered", described as "Swelling at injection site"; PYREXIA (non-serious) with onset 22Sep2023 at 12:45, outcome "not recovered", described as "temperature of 101.7". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of injection site swelling, pyrexia, chills, myalgia, headache, fatigue.  Additional information: Swelling at injection site, temperature of 101.7, bad chills, achy muscles, headache, fatigue. No covid prior vaccination, no covid tested post vaccination.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Swelling at injection site; temperature of 101.7; Bad Chills; Achy Muscles; Headache; Fatigue; Date of start of drug 21Sep2023 , dose number: 4/Date of start of drug 21Sep2023 , dose number: 3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 64-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 at 01:45 as dose 4 (booster), single (Lot number: HF9275) at the age of 64 years intramuscular, in right arm for covid-19 immunisation; bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 21Sep2023 as dose 3 (booster), single (Lot number: GJ6742), in right arm for covid-19 immunisation. The patient's relevant medical history included: "Allergic to peaches, cashews" (unspecified if ongoing); "Allergic to silver and nickel" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII taken for immunisation, start date: 19Sep2023, stop date: 19Sep2023. Vaccination history included: Covid-19 vaccine (DOSE 1, Manufacturer unknown), for COVID-19 immunization; Covid-19 vaccine (DOSE 2, Manufacturer unknown), for COVID-19 immunization. The following information was reported: INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 21Sep2023, outcome "unknown", described as "Date of start of drug 21Sep2023 , dose number: 4/Date of start of drug 21Sep2023 , dose number: 3"; MYALGIA (non-serious) with onset 22Sep2023 at 12:45, outcome "not recovered", described as "Achy Muscles"; CHILLS (non-serious) with onset 22Sep2023 at 12:45, outcome "not recovered", described as "Bad Chills"; FATIGUE (non-serious) with onset 22Sep2023 at 12:45, outcome "not recovered"; HEADACHE (non-serious) with onset 22Sep2023 at 12:45, outcome "not recovered"; INJECTION SITE SWELLING (non-serious) with onset 22Sep2023 at 12:45, outcome "not recovered", described as "Swelling at injection site"; PYREXIA (non-serious) with onset 22Sep2023 at 12:45, outcome "not recovered", described as "temperature of 101.7". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of injection site swelling, pyrexia, chills, myalgia, headache, fatigue.  Additional information: Swelling at injection site, temperature of 101.7, bad chills, achy muscles, headache, fatigue. No covid prior vaccination, no covid tested post vaccination.
Sex: M
Vaccine: COVID19
Symptoms: Pruritus
Clinical narrative: Got some itch/ really itching; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID.  A male patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "allergy to yeast" (ongoing). The patient's concomitant medications were not reported. The following information was reported: PRURITUS (non-serious), outcome "unknown", described as "Got some itch/ really itching".  Additional information: A caller said they got the comirnaty vaccine and her husband got some itch and wanted to know if there was wheat for the ingredients. Comirnaty and/or Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) | COVID-19 Vaccine, mRNA does not contain Gluten. Pfizer used controlled manufacturing processes that meet quality standards of the pharmaceutical industry.  He had an allergy to yeast, and she was trying to look up the ingredients in the shot. She wanted to know if the shot had any yeast in it.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Rash, Syncope
Clinical narrative: Interchange of vaccine products; fainted; broke out in a full body rash/terrible rash; 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 66-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 21Sep2023 as dose 5 (booster), single (Batch/Lot number: unknown) at the age of 66 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna (Dose 1, Single), for COVID-19 immunisation; Moderna (Dose 2, Single), for COVID-19 immunisation; Moderna (Dose 3 (Booster), Single), for COVID-19 immunisation; Moderna (Dose 4 (Booster), Single), for COVID-19 immunisation. The following information was reported: RASH (non-serious) with onset Sep2023, outcome "unknown", described as "broke out in a full body rash"; SYNCOPE (medically significant) with onset Sep2023, outcome "unknown", described as "fainted"; INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 21Sep2023, outcome "unknown". Clinical course: Caller calling about new Pfizer vaccine, she broke out with full body rash and fainted she's asking if these are side effect and what to do. Patient trying to figure out if she should go to the emergency room and patient have a terrible rash from the vaccine. Advised caller to contact the emergency her doctor or go room if experiencing severe allergic reactions to the vaccine. Caller stated that she called about the new Pfizer Vaccine. Had the vaccine last night. Just broke out in a full body rash about 06:00pm. Wanted to know if this a side effect and what to do. Had the other vaccine for Moderna and this was her first Pfizer. Mentioned that she also fainted today and was tried to find out if she should be going to the emergency room. Does not have the product name as it appears on the label or the lot number this was her first Pfizer and had the four others of Moderna.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: RSV
Symptoms: Alopecia, Hypoaesthesia, Injection site pain, Joint range of motion decreased, Malaise
Clinical narrative: 3 days ago, she had Pulmonary embolism; violently sick; losing her hair; Pain in the Injection site; feels that her arm is numb down to fingers and she can't hardly lift her arm; feels that her arm is numb down to fingers and she can't hardly lift her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 05Sep2023 as dose 1, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid vaccine (Dose 1), for COVID-19 immunization; Pfizer covid vaccine (Dose 2), for COVID-19 immunization; Pfizer covid vaccine (Dose 3), for COVID-19 immunization, reaction(s): "falling hair", "violently sick", "pulmonary embolism". The following information was reported: PULMONARY EMBOLISM (medically significant) with onset Sep2023, outcome "unknown", described as "3 days ago, she had Pulmonary embolism"; VACCINATION SITE PAIN (non-serious) with onset Sep2023, outcome "not recovered", described as "Pain in the Injection site"; JOINT RANGE OF MOTION DECREASED (non-serious), HYPOAESTHESIA (non-serious) all with onset Sep2023, outcome "unknown" and all described as "feels that her arm is numb down to fingers and she can't hardly lift her arm"; ALOPECIA (non-serious) with onset Sep2023, outcome "unknown", described as "losing her hair"; MALAISE (non-serious) with onset Sep2023, outcome "unknown", described as "violently sick".  Clinical course details: The case was reported as non-serious. The caller mentioned that she got the RSV vaccine Abrysvo last 05Sep and has a reaction. The patient was currently experiencing pain in the injection site. She also added that she also feels that her arm was numb down to the fingers and she can't hardly lift her arm. She said her arm had no mark or redness, but it hurts on the injection site and it's going on for three weeks since she had it. She was asking if there was anything she can do to get rid of the pain. In addition, her pharmacy advised her to inform us about that she got violently ill when she had her third Pfizer COVID vaccine. According to the patient, she had a terrible reaction to the Covid vaccine where she received 3 shots. She added that 3 days ago, she had pulmonary embolism, she was losing her hair, and she was violently sick. She would also like to know what she could do about this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: RSV
Symptoms: Pulmonary embolism
Clinical narrative: 3 days ago, she had Pulmonary embolism; violently sick; losing her hair; Pain in the Injection site; feels that her arm is numb down to fingers and she can't hardly lift her arm; feels that her arm is numb down to fingers and she can't hardly lift her arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A female patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), on 05Sep2023 as dose 1, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Pfizer covid vaccine (Dose 1), for COVID-19 immunization; Pfizer covid vaccine (Dose 2), for COVID-19 immunization; Pfizer covid vaccine (Dose 3), for COVID-19 immunization, reaction(s): "falling hair", "violently sick", "pulmonary embolism". The following information was reported: PULMONARY EMBOLISM (medically significant) with onset Sep2023, outcome "unknown", described as "3 days ago, she had Pulmonary embolism"; VACCINATION SITE PAIN (non-serious) with onset Sep2023, outcome "not recovered", described as "Pain in the Injection site"; JOINT RANGE OF MOTION DECREASED (non-serious), HYPOAESTHESIA (non-serious) all with onset Sep2023, outcome "unknown" and all described as "feels that her arm is numb down to fingers and she can't hardly lift her arm"; ALOPECIA (non-serious) with onset Sep2023, outcome "unknown", described as "losing her hair"; MALAISE (non-serious) with onset Sep2023, outcome "unknown", described as "violently sick".  Clinical course details: The case was reported as non-serious. The caller mentioned that she got the RSV vaccine Abrysvo last 05Sep and has a reaction. The patient was currently experiencing pain in the injection site. She also added that she also feels that her arm was numb down to the fingers and she can't hardly lift her arm. She said her arm had no mark or redness, but it hurts on the injection site and it's going on for three weeks since she had it. She was asking if there was anything she can do to get rid of the pain. In addition, her pharmacy advised her to inform us about that she got violently ill when she had her third Pfizer COVID vaccine. According to the patient, she had a terrible reaction to the Covid vaccine where she received 3 shots. She added that 3 days ago, she had pulmonary embolism, she was losing her hair, and she was violently sick. She would also like to know what she could do about this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction only to covid vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  An 11-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), in Dec2021 as dose 1, single (Batch/Lot number: unknown) at the age of 11 years for covid-19 immunisation. There were no relevant medical history and no concomitant medications.  The following information was reported: HYPERSENSITIVITY (non-serious), outcome "unknown", described as "Allergic reaction only to covid vaccine".  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-202300309430 same reporter/patient, different dose/AE;
Sex: M
Vaccine: RSV
Symptoms: Influenza like illness
Clinical narrative: Pharmacist stated that pt had "flu-like symptoms"; This is a spontaneous report received from contactable reporter(s) (Pharmacist) from a sales representative.  A male patient received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Batch/Lot number: unknown) for immunisation; for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious), outcome "unknown", described as "Pharmacist stated that pt had "flu-like symptoms"". Additional information: The pharmacist stated that the patient had flu-like symptoms.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Feeling hot, Pruritus
Clinical narrative: having a hot, red, itching upper arm; having a hot, red, itching upper arm; having a hot, red, itching upper arm; 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.  An 80-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), 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: PRURITUS (non-serious), FEELING HOT (non-serious), ERYTHEMA (non-serious), outcome "unknown" and all described as "having a hot, red, itching upper arm". The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.  Additional information: Patient wanted to know if having a hot, red, itching upper arm is a normal side effect. She said it seems to be worsening in the last 4 or 5 days from when she got it and was wondering if that's normal and how long to expect it. She also asked about anything that can be done like put ice, Benadryl or heat.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Decreased appetite, Diarrhoea, Lethargy, Nausea
Clinical narrative: Nausea; weakness; lethargy; sore arm; vomiting; diarrhea; no appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Sep2023 at 13:45 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: NAUSEA (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering"; DIARRHOEA (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering", described as "diarrhea"; LETHARGY (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering", described as "no appetite"; PAIN IN EXTREMITY (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering", described as "sore arm"; VOMITING (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering"; ASTHENIA (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering", described as "weakness". Therapeutic measures were not taken as a result of nausea, asthenia, lethargy, pain in extremity, vomiting, diarrhoea, decreased appetite.  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.
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Nausea; weakness; lethargy; sore arm; vomiting; diarrhea; no appetite; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 02Sep2023 at 13:45 as dose 1, single (Batch/Lot number: unknown) at the age of 67 years, in right arm for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ROSUVASTATIN. The following information was reported: NAUSEA (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering"; DIARRHOEA (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering", described as "diarrhea"; LETHARGY (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering"; DECREASED APPETITE (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering", described as "no appetite"; PAIN IN EXTREMITY (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering", described as "sore arm"; VOMITING (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering"; ASTHENIA (non-serious) with onset 24Sep2023 at 16:00, outcome "recovering", described as "weakness". Therapeutic measures were not taken as a result of nausea, asthenia, lethargy, pain in extremity, vomiting, diarrhoea, decreased appetite.  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: Condition aggravated, Neuropathy peripheral, Nightmare, Pain, Urine analysis abnormal
Clinical narrative: neuropathy is terrible, extremely painful, my feet is much much worse; It has never been this bad, very painful; I had a little neuropathy and it is much worse, correct. It has never been this bad; I am having an unusual terrible reaction; unbelievably horrible nightmares; Nightmares are unbelievably horrific; Seems to be affecting my urine; neuropathy is terrible, extremely painful, my feet is much much worse; It has never been this bad, very painful; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult patient received bnt162b2 omi xbb.1.5 (BNT162B2 OMI XBB.1.5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "I had a little neuropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: NEUROPATHY PERIPHERAL (medically significant), PAIN (non-serious), outcome "unknown" and all described as "neuropathy is terrible, extremely painful, my feet is much much worse; It has never been this bad, very painful"; CONDITION AGGRAVATED (medically significant), outcome "unknown", described as "I had a little neuropathy and it is much worse, correct. It has never been this bad"; NIGHTMARE (non-serious), outcome "unknown", described as "I am having an unusual terrible reaction; unbelievably horrible nightmares; Nightmares are unbelievably horrific"; URINE ANALYSIS ABNORMAL (non-serious), outcome "unknown", described as "Seems to be affecting my urine". The patient underwent the following laboratory tests and procedures: Urine analysis: It seems to be affecting my urine. Clinical course: Consumer stated, I just took the COVID vaccine and I am having an unusual terrible reaction. I am having unbelievably horrible nightmares. It seems to be affecting my urine. I also have an advance case of neuropathy and my neuropathy is all terrible, extremely painful and they said the dreams, the nightmares are unbelievably horrific. I have never had any like this in my life. When paraphrased the above concern, consumer stated, Neuropathy, my feet is much much worse. I had a little neuropathy and it is much worse, correct. It has never been this bad, very painful and the nightmares on the other hand, horrific nightmares.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Bone pain, Chills, Fatigue, Headache
Clinical narrative: within a few hours, chills, pain in joints and bone and muscles, fatigue, headache; within a few hours, chills, pain in joints and bone and muscles, fatigue, headache; within a few hours, chills, pain in joints and bone and muscles, fatigue, headache; within a few hours, chills, pain in joints and bone and muscles, fatigue, headache; within a few hours, chills, pain in joints and bone and muscles, fatigue, headache; within a few hours, chills, pain in joints and bone and muscles, fatigue, headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: CHILLS (non-serious), ARTHRALGIA (non-serious), BONE PAIN (non-serious), MYALGIA (non-serious), FATIGUE (non-serious), HEADACHE (non-serious), outcome "recovering" and all described as "within a few hours, chills, pain in joints and bone and muscles, fatigue, headache". Therapeutic measures were not taken as a result of chills, arthralgia, bone pain, myalgia, fatigue, headache. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Sep2023, the patient received BNT162 OMICRON (XBB 1.5) within four weeks to the previous COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: within a few hours, chills, pain in joints and bone and muscles, fatigue, headache; within a few hours, chills, pain in joints and bone and muscles, fatigue, headache; within a few hours, chills, pain in joints and bone and muscles, fatigue, headache; within a few hours, chills, pain in joints and bone and muscles, fatigue, headache; within a few hours, chills, pain in joints and bone and muscles, fatigue, headache; within a few hours, chills, pain in joints and bone and muscles, fatigue, headache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 41-year-old female patient (not pregnant) received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), 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: CHILLS (non-serious), ARTHRALGIA (non-serious), BONE PAIN (non-serious), MYALGIA (non-serious), FATIGUE (non-serious), HEADACHE (non-serious), outcome "recovering" and all described as "within a few hours, chills, pain in joints and bone and muscles, fatigue, headache". Therapeutic measures were not taken as a result of chills, arthralgia, bone pain, myalgia, fatigue, headache. Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. On 20Sep2023, the patient received BNT162 OMICRON (XBB 1.5) within four weeks to the previous COVID vaccine.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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. 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 "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  The information on the batch/lot number for bnt162b2 omi xbb.1.5, 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-202300305697 same patient, different dose/event.;
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough
Clinical narrative: tested positive; tested positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 20Sep2023 as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (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. 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 "tested positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive.  The information on the batch/lot number for bnt162b2 omi xbb.1.5, 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-202300305697 same patient, different dose/event.;
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: she gets a cough every time she gets a Covid shot or vaccine; 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), in 2022 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): "she gets a cough every time she gets a Covid shot or vaccine". The following information was reported: COUGH (non-serious) with onset 2022, outcome "unknown", described as "she gets a cough every time she gets a Covid shot or vaccine".  Additional information: the reporter states she also has a weird cough, states she gets a cough every time she gets a Covid shot or vaccine.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19, COVID19, COVID19
Symptoms: Cough
Clinical narrative: she gets a cough every time she gets a Covid shot or vaccine; 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), in 2022 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): "she gets a cough every time she gets a Covid shot or vaccine". The following information was reported: COUGH (non-serious) with onset 2022, outcome "unknown", described as "she gets a cough every time she gets a Covid shot or vaccine".  Additional information: the reporter states she also has a weird cough, states she gets a cough every time she gets a Covid shot or vaccine.   The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain, Vaccination site pain
Clinical narrative: Sore injection site; Body aches; Headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 22Sep2023 at 13:00 as dose 4 (booster), single (Batch/Lot number: unknown), in right arm for covid-19 immunisation; influenza vaccine (FLU [INFLUENZA VACCINE]), on 22Sep2023 as dose number unknown, single (Batch/Lot number: unknown) for influenza immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: STOOL SOFTENER. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunisation; Covid-19 vaccine (DOSE 3 (BOOSTER); MANUFACTURER UNKNOWN), for COVID-19 immunisation. The following information was reported: PAIN (non-serious) with onset 22Sep2023 at 22:00, outcome "not recovered", described as "Body aches"; HEADACHE (non-serious) with onset 22Sep2023 at 22:00, outcome "not recovered"; VACCINATION SITE PAIN (non-serious) with onset 22Sep2023 at 22:00, outcome "not recovered", described as "Sore injection site". Therapeutic measures were not taken as a result of vaccination site pain, pain, headache.  Additional information: Patient had not have covid prior to vaccination and not tested covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: with the first two vaccines, they pinched up her skin to give the vaccine and it hurt really bad; 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 76-year-old female patient received bnt162b2 (BNT162B2 NOS), as dose 2, single (Batch/Lot number: unknown), in arm 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): "with the first two vaccines, they pinched up her skin to give the vaccine and it hurt really bad". The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "with the first two vaccines, they pinched up her skin to give the vaccine and it hurt really bad".  Additional information: Patient stated that she states she has had 4 covid vaccines in the past, all Pfizer and with the first two vaccines, they pinched up her skin to give the vaccine and it hurt really bad. The 1st and 2nd hurt really bad at injection site, but she noticed it was when nurse pinched up skin to give injection. The 3rd and 4th she asked them not to do that and it didn't hurt. Her husband had the same experience. She thinks that's why her arm was so sore and thought she would pass it on if it would help. It just came up in the conversation because she remembers how her whole arm hurt.    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-202300309739 same patient, different dose, different event;
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site swelling, Vomiting
Clinical narrative: Swollen injection site for multiple days; Vomiting; Fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 24-year-old female patient (not pregnant) received bnt162b2 omi xbb.1.5 (COVID-19 VACCINE OMI XBB.1.5 - MANUFACTURER UNKNOWN), as dose 3 (booster), single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "COVID-19" (unspecified if ongoing), notes: If COVID prior vaccination: Yes, covid treatment: Yes; "Beta Thalassemia" (unspecified if ongoing). The patient took concomitant medications. Vaccination history included: Covid -19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 Immunisation; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN, Anatomical location: Right arm), for COVID-19 Immunisation. The following information was reported: VACCINATION SITE SWELLING (non-serious), outcome "recovering", described as "Swollen injection site for multiple days"; VOMITING (non-serious), outcome "recovering"; PYREXIA (non-serious), outcome "recovering", described as "Fever". Therapeutic measures were not taken as a result of vaccination site swelling, vomiting, pyrexia.  Additional information: Patient did not receive other vaccine in four weeks. She had other medications in two weeks. She had not tested for covid post vaccination.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.