chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus
Clinical narrative: bruise about injection site and red spot underneath; bruise about injection site and red spot underneath; bruise right about injection site which she is not comfortable about; she got the booster; it is about 5 inches by 1 inch and is just getting bigger, wants to know if this is norma/bruise that is slightly above the injection site and a red spot that is getting worse; itchy/itches below the injection site that is painful; itchy/itches below the injection site that is painful; 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 71 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 19Nov2021 (Lot number: 33030BD) as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Second dose, LOT-ER8731), administration date: 22Apr2021, for Covid-19 immunization, reaction(s): "tired", "sore arm"; Bnt162b2 (First dose, LOT-ER8735), administration date: 01Apr2021, for Covid-19 immunization. The following information was reported: VACCINATION SITE BRUISING (non-serious), VACCINATION SITE ERYTHEMA (non-serious) all with onset 20Nov2021, outcome "not recovered" and all described as "bruise about injection site and red spot underneath"; VACCINATION SITE PAIN (non-serious) with onset Nov2021, outcome "unknown", described as "itchy/itches below the injection site that is painful"; VACCINATION SITE PRURITUS (non-serious) with onset Nov2021, outcome "unknown", described as "itchy/itches below the injection site that is painful "; VACCINATION SITE DISCOMFORT (non-serious) with onset 20Nov2021, outcome "not recovered", described as "bruise right about injection site which she is not comfortable about"; CONDITION AGGRAVATED (non-serious) with onset Nov2021, outcome "not recovered", described as "it is about 5 inches by 1 inch and is just getting bigger, wants to know if this is norma/bruise that is slightly above the injection site and a red spot that is getting worse"; IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "she got the booster".  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Immunisation, Peripheral swelling
Clinical narrative: just a little red and swollen/ there is redness underneath the Tape; just a little red and swollen/ her arm is a little swollen; she got the booster yesterday; 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 female patient received bnt162b2 (BNT162B2), administration date 22Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, she did not have any side effects when she received the first two doses of Pfizer BioNTech covid vaccine), for Covid-19 immunization; Bnt162b2 (Dose 2, she did not have any side effects when she received the first two doses of Pfizer BioNTech covid vaccine), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "she got the booster yesterday"; ERYTHEMA (non-serious) with onset 23Nov2021, outcome "unknown", described as "just a little red and swollen/ there is redness underneath the Tape"; PERIPHERAL SWELLING (non-serious) with onset 23Nov2021, outcome "unknown", described as "just a little red and swollen/ her arm is a little swollen".   Additional information: It was reported that the patient received booster shot yesterday. and this morning she has noted that her arm is a little swollen and there is redness underneath the Tape. she wants to know if these are normal reactions as she did not have any side effects when she received the first two doses of Pfizer BioNtech covid vaccine. She also asked is that anything to be concerned about. She states she never had any reactions. When patient was directed to physician for additional guidance, she mentioned that she was not worried at all, and she will wait for a couple of days for it to subside and she just wanted to know if these are reported side effects? In the response of the patient's questions, it was reported as in general local side effects such as the redness and swelling of the injection side are considered mild to moderate side effects that are expected to subside within 1-2 days after receiving the dose.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 64.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Product preparation error
Clinical narrative: This is a spontaneous report received from a contactable other HCP. A 64-year-old male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), at the age of 64, 2021, 0.3mL, single dose, for COVID-19 immunisation; and received unknown dose number of  mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# unknown), 2021, 0.3mL, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient reported booster/immunization/product preparation error, onset 2021, with outcome of unknown. Described as "drew up 1.8mLs of the Moderna vaccine and used it as diluent in the COVID-19 adult formula vaccine vial." The lot number for BNT162B2 not provided and will be requested during follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Immunisation, Pain in extremity, Peripheral swelling
Clinical narrative: booster; feeling great pain in her left leg and could not even walk, her leg was feeling hard; feeling great pain in her left leg and could not even walk, her leg was feeling hard; her left leg is swollen and painful; 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 (BNT162B2), administered in arm left, administration date 21Nov2021 10:30 (Batch/Lot number: unknown) as dose 3 (booster), single 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; Bnt162b2 (dose 2), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Nov2021, outcome "unknown", described as "booster"; PAIN IN EXTREMITY (non-serious) with onset 21Nov2021, outcome "not recovered", GAIT DISTURBANCE (non-serious) with onset 21Nov2021, outcome "unknown" and all described as "feeling great pain in her left leg and could not even walk, her leg was feeling hard"; PERIPHERAL SWELLING (non-serious) with onset Nov2021, outcome "not recovered", described as "her left leg is swollen and painful". Therapeutic measures were taken as a result of pain in extremity, gait disturbance, peripheral swelling.  Clinical course: It was stated she received Pfizer COVID-19 vaccination booster (3rd dose) on Sunday 21Nov2021 at 10:30 AM, in her left arm. After one hour, or less than half an hour on the car, she started feeling great pain in her left leg and could not even walk, her leg was feeling hard. She is still feeling a lot of pain, even after taking 800 mg ibuprofen, and her left leg is swollen. She mentioned that she did not experience side effects after the 1st and 2nd doses of the vaccine. Now her left leg is swollen and painful, yesterday she went to see a stomach doctor who did not know what was going on. Caller wanted to know if someone else reported this.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pain in extremity, Peripheral swelling
Clinical narrative: The third dose of the Pfizer vaccine for Covid-19; Feel a torable pain in the left leg at the bottom/leg hurts; Leg was swollen; 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 female patient received BNT162B2, administered in arm left, on 21Nov2021 at 10:30 (Batch/Lot number: unknown) at the age of 64 years as dose 3 (booster), single for covid-19 immunization. The patient's medical history and concomitant medications were not reported. Patient previously received first and second dose of Bnt162b2, on unspecified dates for COVID-19 immunization. On 21Nov2021 10:30, patient experienced the third dose of the Pfizer vaccine for covid-19, Feel a torable pain in the left leg at the bottom/leg hurts, on an unspecified date in nov2021 Leg was swollen. Therapeutic measures were taken as a result of pain in extremity, peripheral swelling. The outcome of all events was not recovered the third dose of the Pfizer vaccine for covid-19 was unknown.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Blister, Herpes zoster, Immunisation, Pain, Pruritus
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 (Lot number: Ff8841) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Dibities (unspecified if ongoing); BP (unspecified if ongoing); Allergy (unspecified if ongoing). The patient took concomitant medications. Vaccination history included Moderna (Dose Number: 2, Batch/Lot No: 013L20A, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 18Jan2021, for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 016H20A, Location of injection: Arm Left, Vaccine Administration Time: 02:00 AM), administration date: 15Feb2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021, outcome unknown; RASH (non-serious), BLISTER (non-serious), PRURITUS (non-serious), PAIN (non-serious) all with onset 16Nov2021, outcome not recovered; HERPES ZOSTER (non-serious) with onset 16Nov2021, outcome not recovered. Doctor said it's singles and were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of rash, blister, pruritus, pain. Therapeutic measures were taken as a result of herpes zoster.   The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received medications for diabetics and BP within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19, Since the vaccination. Patient received 1 g vvalacyclovir for shingles.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, SARS-CoV-2 test
Clinical narrative: This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 74 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Nov2021 (Lot number: Ff8841) at the age of 74 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Dibities (unspecified if ongoing); BP (unspecified if ongoing); Allergy (unspecified if ongoing). The patient took concomitant medications. Vaccination history included Moderna (Dose Number: 2, Batch/Lot No: 013L20A, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 18Jan2021, for COVID-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 016H20A, Location of injection: Arm Left, Vaccine Administration Time: 02:00 AM), administration date: 15Feb2021, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Nov2021, outcome unknown; RASH (non-serious), BLISTER (non-serious), PRURITUS (non-serious), PAIN (non-serious) all with onset 16Nov2021, outcome not recovered; HERPES ZOSTER (non-serious) with onset 16Nov2021, outcome not recovered. Doctor said it's singles and were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of rash, blister, pruritus, pain. Therapeutic measures were taken as a result of herpes zoster.   The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient received medications for diabetics and BP within 2 weeks of vaccination. The patient was not diagnosed with COVID-19 prior to vaccination. The patient has not been tested for COVID-19, Since the vaccination. Patient received 1 g vvalacyclovir for shingles.
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Vomiting
Clinical narrative: Booster dose; Gastrointestinal side effects/vomiting; This is a spontaneous report received from contactable reporter(s) (Other HCP and Physician) from medical information team. The reporter is the parent. Other Case identifier(s):PFIZER INC-202101647307 (Pfizer).  A 16 year-old female patient received bnt162b2 (BNT162B2), administration date 22Nov2021 (Batch/Lot number: unknown) at the age of 16 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:01), when the patient was 16 years old, for COVID-19 immunization; Bnt162b2 (Dose:02), when the patient was 16 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021, outcome "unknown", described as "Booster dose"; VOMITING (non-serious) with onset 2021, outcome "unknown", described as "Gastrointestinal side effects/vomiting".  Additional Information: Question: Practice manager said she has a patient who is concerned that her 16-year-old daughter received the booster dose of the Pfizer-BioNTech Covid-19 Vaccine. She said she is worried because the booster has not been approved for individuals 16 years of age yet. She said the daughter is having the regular side effects. She wants to confirm if the booster dose is really not approved for individuals 16 years of age. I was about to provide her the information, but after I got back on the line, I couldn't hear anything anymore. I waited for a few minutes but to no avail. I said I would hang up and call her back. A single booster dose of the vaccine may be administered at least 6 months after completion of a primary series to individuals 18 years of age and older. I would tell her that there is no information about the booster dose being administered to patients below 18 years of age. Question: Call initiated by practice supervisor. She put the doctor on the phone. Do you have information on a 16 year old receiving a booster dose of the vaccine? Etransmitting possible duplicate/additional AE info. HCP states that a healthy 16 year old patient received a booster dose of the Pfizer COVID 19 vaccine at a pharmacy and is experiencing gastrointestinal side effects. She's vomiting. Response: Spoke from SRD: COMIRNATY and the Pfizer-BioNTech COVID-19 Vaccine (purple or gray cap) are authorized for use under from FDA to provide a third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise and as a single booster dose in individuals 18 years of age and older who have completed a primary series with Pfizer-BioNTechCOVID-19 Vaccine or COMIRNATY Faxing SRD, per request.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation, Migraine
Clinical narrative: Booster; Booster sparked a severe migraine episode; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Got a more severe reaction than the initial two. I had Botox injected a little over a month ago for migraines), for COVID-19 Immunization, reaction(s): "Got a more severe reaction than the initial two"; Covid-19 vaccine (Dose: 2, Got a more severe reaction than the initial two. I had Botox injected a little over a month ago for migraines), for COVID-19 Immunization, reaction(s): "Got a more severe reaction than the initial two". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; MIGRAINE (non-serious), outcome "unknown", described as "Booster sparked a severe migraine episode". The event "booster sparked a severe migraine episode" was evaluated at the emergency room visit.  The patient recently took the booster shot and got a more severe reaction than the initial two. The patient had Botox injected a little over a month ago for migraines and the booster sparked a severe migraine episode that had to go to the ER. Please do some research on this so other migraine sufferers with Botox treatment are aware. Perhaps the serum can be altered to avoid this reaction.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: Swelling in the lymph nodes under her arm; Where she got the shot is itching, red and sore; Where she got the shot is itching, red and sore; Where she got the shot is itching, red and sore; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 63 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 21Nov2021 (Lot number: FH8030) at the age of 63 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Diabetes", start date: 2000 (ongoing), notes: Verbatim: Diabetes. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (First vaccine: , NDC/expiration: unknown/31Jul2021, Lot: ER8727, Site: unknown), administration date: 01Apr2021, when the patient was 62 years old, for COVID-19 Immunization; Covid-19 vaccine (Second vaccine: , NDC/expiration: 31Aug2021, Lot: EW0170, Site: unknown), administration date: 22Apr2021, when the patient was 62 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 21Nov2021, outcome "unknown", described as "Booster"; LYMPHADENOPATHY (non-serious) with onset 22Nov2021, outcome "not recovered", described as "Swelling in the lymph nodes under her arm"; VACCINATION SITE PRURITUS (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 21Nov2021, outcome "not recovered" and all described as "Where she got the shot is itching, red and sore"; VACCINATION SITE ERYTHEMA (non-serious) with onset 22Nov2021, outcome "not recovered".  The patient didn't taken prior vaccinations list any other vaccinations within four weeks prior to the first administration date of the suspect vaccine  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Rash
Clinical narrative: She broke in a crazy rash; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; RASH (non-serious), outcome "not recovered", described as "She broke in a crazy rash". Clinical course: This report is not related to a study or programme. Reporter does not know the patient personally. Reporter is a Pharmacy Technician. Caller stated that she has a girlfriend, who has a neighbour across the street that got the booster, and she broke in a crazy rash which went away but then would come back on a Monday go away Tuesday, come back Wednesday, and this happened for months. When probed for the Lot and Expiry date of the Covid Booster for this neighbour's experience, caller stated that she doesn't know her, it's her friends neighbour, she did not have a lot or expiry.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Tongue discomfort
Clinical narrative: Booster; She has no feeling on the upper part of her tongue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer Unknown), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; TONGUE DISCOMFORT (non-serious) with onset 2021, outcome "not recovered", described as "She has no feeling on the upper part of her tongue".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Axillary pain, Cough, Fatigue, Immunisation, Influenza like illness
Clinical narrative: Flu like symptoms; horrific cough; Feverish; I was so fatigue I could not get out of it; runny nose; I am blowing a lot, it is nothing but a clear mucous; armpit very bad soreness under the ''shot arm'' and it actually traced over to my right arm, which was not the ''shot arm''; soreness really bad on to my left armpit; got the Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 60-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: 320308D, Expiration Date: 28Feb2022) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation; dulaglutide (TRULICITY), subcutaneous (Batch/Lot number: unknown) as 1.5 mg, weekly. Relevant medical history included: "Type II Diabetic" (unspecified if ongoing), notes: Verbatim: Type II Diabetic. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Mar2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "I had no issue"; Bnt162b2 (Dose: 2), administration date: Mar2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "I had no issue"; Flu shot (I got the Flu shot (Unspecified Flu shot) yeah in Oct2021.), administration date: Oct2021, when the patient was 60 years old, for Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "got the Pfizer booster"; AXILLARY PAIN (non-serious) with onset 18Nov2021, outcome "recovering", described as "armpit very bad soreness under the ''shot arm'' and it actually traced over to my right arm, which was not the ''shot arm''; soreness really bad on to my left armpit"; INFLUENZA LIKE ILLNESS (non-serious) with onset 19Nov2021, outcome "recovering", described as "Flu like symptoms"; COUGH (non-serious) with onset 19Nov2021, outcome "recovering", described as "horrific cough"; PYREXIA (non-serious) with onset 19Nov2021, outcome "recovering", described as "Feverish"; FATIGUE (non-serious) with onset 19Nov2021, outcome "recovering", described as "I was so fatigue I could not get out of it"; RHINORRHOEA (non-serious) with onset 19Nov2021, outcome "recovering", described as "runny nose; I am blowing a lot, it is nothing but a clear mucous". Therapeutic measures were taken as a result of axillary pain, influenza like illness, cough, pyrexia, fatigue, rhinorrhoea.  Additional information: Patient had received Robitussin cough syrup as treatment for the cough.  Follow-up attempts are completed. No further information is expected.
Age: 60.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Flu like symptoms; horrific cough; Feverish; I was so fatigue I could not get out of it; runny nose; I am blowing a lot, it is nothing but a clear mucous; armpit very bad soreness under the ''shot arm'' and it actually traced over to my right arm, which was not the ''shot arm''; soreness really bad on to my left armpit; got the Pfizer booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 60-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Nov2021 (Lot number: 320308D, Expiration Date: 28Feb2022) at the age of 60 years as dose 3 (booster), single for covid-19 immunisation; dulaglutide (TRULICITY), subcutaneous (Batch/Lot number: unknown) as 1.5 mg, weekly. Relevant medical history included: "Type II Diabetic" (unspecified if ongoing), notes: Verbatim: Type II Diabetic. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1), administration date: Mar2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "I had no issue"; Bnt162b2 (Dose: 2), administration date: Mar2021, when the patient was 59 years old, for Covid-19 immunization, reaction(s): "I had no issue"; Flu shot (I got the Flu shot (Unspecified Flu shot) yeah in Oct2021.), administration date: Oct2021, when the patient was 60 years old, for Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 17Nov2021, outcome "unknown", described as "got the Pfizer booster"; AXILLARY PAIN (non-serious) with onset 18Nov2021, outcome "recovering", described as "armpit very bad soreness under the ''shot arm'' and it actually traced over to my right arm, which was not the ''shot arm''; soreness really bad on to my left armpit"; INFLUENZA LIKE ILLNESS (non-serious) with onset 19Nov2021, outcome "recovering", described as "Flu like symptoms"; COUGH (non-serious) with onset 19Nov2021, outcome "recovering", described as "horrific cough"; PYREXIA (non-serious) with onset 19Nov2021, outcome "recovering", described as "Feverish"; FATIGUE (non-serious) with onset 19Nov2021, outcome "recovering", described as "I was so fatigue I could not get out of it"; RHINORRHOEA (non-serious) with onset 19Nov2021, outcome "recovering", described as "runny nose; I am blowing a lot, it is nothing but a clear mucous". Therapeutic measures were taken as a result of axillary pain, influenza like illness, cough, pyrexia, fatigue, rhinorrhoea.  Additional information: Patient had received Robitussin cough syrup as treatment for the cough.  Follow-up attempts are completed. No further information is expected.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Chills, Immunisation, Pain in extremity, Tremor
Clinical narrative: Booster; I started to get chills and shake; this is uncontrollable for 2 hours uncontrol I mean I could not hold glass of water I was shaking so bad; I started to get chills and shake; this is uncontrollable for 2 hours uncontrol I mean I could not hold glass of water I was shaking so bad; My arm is too sore; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Nov2021 (Batch/Lot number: unknown) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing), notes: Verbatim: High blood pressure. Concomitant medication(s) included: LOSARTAN taken for hypertension. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Lot# for second shot: Consumer stated, "EW0172", Date of second shot: 26Apr2021, AE=I got really nauseous), administration date: 26Apr2021, when the patient was 61 years old, for COVID-19 immunization, reaction(s): "I got really nauseous", "low blood pressure"; Bnt162b2 (DOSE 1, SINGLE), for COVID-19 IMMUNIZATION; Flu vaccine (I had a flu vaccine (Unspecified Vaccine). I think I have that 2 weeks prior to this vaccine.). The following information was reported: IMMUNISATION (non-serious) with onset 20Nov2021, outcome "unknown", described as "Booster"; CHILLS (non-serious), TREMOR (non-serious) all with onset Nov2021, outcome "unknown" and all described as "I started to get chills and shake; this is uncontrollable for 2 hours uncontrol I mean I could not hold glass of water I was shaking so bad"; PAIN IN EXTREMITY (non-serious) with onset Nov2021, outcome "unknown", described as "My arm is too sore". The patient underwent the following laboratory tests and procedures: blood pressure measurement: low, notes: drop in blood pressure probably like 74 over 54. Therapeutic measures were taken as a result of tremor.  Additional information: Treatment for Adverse Event: Consumer stated, took like rice pack and warm them up in the microware so they could be like heat pack  put around  to help stop shaking. Consumer stated, had a flu vaccine (Unspecified Vaccine). think had at 2 week prior to this vaccine.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Discomfort, Immunisation, Pain, Sleep disorder
Clinical narrative: titanium parts - right hip, fusion site to lumbar/sacral spine and cardiac stents became extremely pain-filled; I could not function, sleep, sit without major discomfort; I could not function, sleep, sit without major discomfort; Got booster on 19Nov2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (005570). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 19Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid-19" (unspecified if ongoing), notes: Quick background - had Covid twice before Jan2021. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Received vaccine in Feb2021. 1st injection - mild reaction, 2nd injection put me down for about 36 hours), administration date: Feb2021, for COVID-19 immunization, reaction(s): "mild reaction", "put me down for about 36 hours".The following information was reported: IMMUNISATION (non-serious) with onset 19Nov2021, outcome "unknown", described as "Got booster on 19Nov2021"; PAIN (non-serious), outcome "unknown", described as "titanium parts - right hip, fusion site to lumbar/sacral spine and cardiac stents became extremely pain-filled"; SLEEP DISORDER (non-serious), DISCOMFORT (non-serious), outcome "unknown" and all described as "I could not function, sleep, sit without major discomfort". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Diarrhoea, Feeling abnormal, Headache, Immunisation
Clinical narrative: diarrhea; headaches; brain fog; Anxiety; Booster Dose; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old patient received bnt162b2 (BNT162B2), administration date 30Oct2021 (Lot number: EN0151) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Seizure Disorder", start date: Jan1982 (ongoing), notes: Head Injury. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:2nd, AE equired visit to : Physician Office, AE outcome: Recovered, Treatment: Did the event require the initiation of new medication/ other treatment/procedure?: No), administration date: 15Apr2021, for COVID-19 immunization; Bnt162b2 (Dose:1), for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 30Oct2021, outcome "unknown", described as "Booster Dose"; DIARRHOEA (non-serious) with onset Nov2021, outcome "recovering", described as "diarrhea"; HEADACHE (non-serious) with onset Nov2021, outcome "recovering", described as "headaches"; FEELING ABNORMAL (non-serious) with onset Nov2021, outcome "recovering", described as "brain fog"; ANXIETY (non-serious) with onset Nov2021, outcome "recovering", described as "Anxiety". The events "diarrhea", "headaches", "brain fog" and "anxiety" were evaluated at the physician office visit.  Additional information: In the previous form sent in months ago the reported the details following second shot how it may have been an actual covid infection or some other infection with similar symptoms (5 days in bed, severe headache, fever, horrible sinus get cough, brain fog, 3 months of tiredness). Received the Booster a few week ago and it was not good. A week of diarrhea, headache put me noticeable fever. But there was a brain fog a kind of anxiety, like an extreme level of caffeine, that had lasted a few week was now getting better. I would not do that again. Pt rarely sick had exercised everyday (handwriting not understandable. Was in great shape.  The lot number for the vaccine BNT162B2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: booster; the lymph node under his arm had discomfort and is swollen; the lymph node under his arm had discomfort and is swollen; 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 male patient received bnt162b2 (BNT162B2), administration date 21Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single 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; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious) with onset Nov2021, outcome "unknown", IMMUNISATION (non-serious), outcome "unknown" and all described as "booster"; LYMPHADENOPATHY (non-serious), outcome "unknown", described as "the lymph node under his arm had discomfort and is swollen". The lot number for bnt162b2 was not provided and will be requested during follow up.  Additional information  Caller is a consumer that was calling about the Covid-19 Booster that he received on 21Nov2021. Caller said that he noticed maybe 24 hours afterward, he thinks his lymph node under his right arm has some discomfort and noticed today that it feels swollen in that area. He said that he feels fine other than that. Caller said that he does not remember having this issue with the other 2 doses.   No Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Rash, Varicella
Clinical narrative: Booster; Chicken pox like outbreak; Rash; This is a spontaneous report received from contactable reporter(s) (Other HCP).  A female patient in her 50's received bnt162b2 (COMIRNATY), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 Immunization; Bnt162b2 (Dose 2), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 2021, outcome "unknown", described as "Booster"; VARICELLA (non-serious) with onset 2021, outcome "unknown", described as "Chicken pox like outbreak"; RASH (non-serious) with onset 2021, outcome "unknown", described as "Rash".   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Vaccination site pain
Clinical narrative: injection site was very sore; fatigued; Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 44-year-old male patient received BNT162B2 ((PFIZER-BIONTECH COVID-19 VACCINE, formulation: Solution for injection) (Batch/Lot number: unknown) as dose number unknown (booster), single for COVID-19 immunisation. The patient relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (DOSE 1), for COVID-19 Immunization, BNT162B2 (DOSE 2), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "injection site was very sore"; FATIGUE (non-serious), outcome "unknown", described as "fatigued"; IMMUNISATION (non-serious), outcome "unknown", described as "Booster".  The lot number for BNT162B2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain, Vaccination site pain
Clinical narrative: Booster; body aches; soreness at the injection site; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 23Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (dose 1, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (dose 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 23Nov2021, outcome "unknown", described as "Booster"; PAIN (non-serious) with onset 23Nov2021, outcome "recovering", described as "body aches"; VACCINATION SITE PAIN (non-serious) with onset 23Nov2021, outcome "recovering", described as "soreness at the injection site"; FATIGUE (non-serious) with onset 23Nov2021, outcome "recovering", described as "fatigue".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Interchange of vaccine products, Migraine, Off label use
Clinical narrative: Pt has had the COVID vaccine at least the first one, it was Moderna, uh she started in February, um she had booster of Pfizer, uh no indication of another vaccine; had the COVID vaccine at least the first one, it was Moderna, uh she started in Feb; Pt has had the COVID vaccine at least the first one, it was Moderna, uh she started in February, um she had booster of Pfizer, uh no indication of another vaccine; she went 2 days without the medication and had a migraine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): AGN278931 (Allergan).  A female patient received bnt162b2 (BNT162B2), administration date 2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; atogepant (ATOGEPANT), since Oct2021 (ongoing) (Lot number: W05836, Expiration Date: Nov2023). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Moderna covid 19 vaccine (COVID vaccine at least the first one, it was Moderna, uh she started in February), administration date: Feb2021, for Covid-19 Immunization; Covid-19 vaccine (Primary Immunization series complete but unknown manufacturer), for Covid-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), IMMUNISATION (non-serious) all with onset 2021, outcome "unknown" and all described as "Pt has had the COVID vaccine at least the first one, it was Moderna, uh she started in February, um she had booster of Pfizer, uh no indication of another vaccine"; INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 2021, outcome "unknown", described as "had the COVID vaccine at least the first one, it was Moderna, uh she started in Feb"; MIGRAINE (non-serious) with onset 2021, outcome "unknown", described as "she went 2 days without the medication and had a migraine". The action taken for atogepant was dosage not changed.  Additional information: Her issue was she was on the Qulipta, this is for Qulipta, uh she was taking the Qulipta for 12 days, and then um she uh she started in mid october, she went 2 days without the medication and had a migraine. She's now been back on it for 1 week. The lot number is W05836 and the exp date is Nov2023, 2023. Patient had the COVID vaccine at least the first one, it was Moderna, uh she started in February, um she had booster of Pfizer, uh no indication of another vaccine. It was unknown whether the patient was pregnant and breastfeeding. The patient did not hospitalized or was hospitalization prolonged as a result of the adverse events.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Immunisation, Pain, Vaccination site pain
Clinical narrative: Sore at injection site; mild achiness; fatigue; dose number=3; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient. A 48-year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 22Nov2021 18:15 (Lot number: FH8030) at the age of 48 years as dose 3 (booster dose), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Prev dose product Covid 19, prev dose brand Pfizer, prev dose brand unknown False, prev dose lot number unknown EN6203, prev dose lot unknown reason False, prev dose administration date 01Mar2021, prev dose number 2, prev dose vaccine location Right arm), administration date: 01Mar2021, when the patient was 47 years old, for Covid-19 immunization; Bnt162b2 (Prev dose product Covid 19, prev dose brand Pfizer, prev dose brand unknown False, prev dose lot number unknown EN9581, prev dose lot unknown reason False, prev dose administration date 08Feb2021, prev dose number 1, prev dose vaccine location Right arm), administration date: 08Feb2021, when the patient was 47 years old, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 22Nov2021 18:15, outcome "unknown", described as "dose number=3"; VACCINATION SITE PAIN (non-serious) with onset 23Nov2021 13:00, outcome "recovered", described as "Sore at injection site"; PAIN (non-serious) with onset 23Nov2021 13:00, outcome "recovered", described as "mild achiness"; FATIGUE (non-serious) with onset 23Nov2021 13:00, outcome "recovered", described as "fatigue". Therapeutic measures were not taken as a result of vaccination site pain, pain, fatigue.  Additional information: Patient didn't received other vaccines with 4 weeks prior to vaccination. Patient didn't had covid-19 prior to vaccination. Patient was not tested with Covid-19 to post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alanine aminotransferase, Aspartate aminotransferase, Autoimmune hepatitis, Biopsy liver, Blood alkaline phosphatase
Clinical narrative: seronegative AIH or drug induced AIH;   Herein, the authors present a patient with drug-induced AIH with possible relation to Pfizer-BioNTech COVID-19 vaccine. Case Description/Methods: A 38-year-old female with a history of Helicobacter pylori treated with amoxicillin and pantoprazole three months ago and recent COVID-19 vaccination presented with two weeks of right upper quadrant pain and diarrhea. Patient received second dose of vaccination two weeks prior to symptom onset. Five days post-symptom onset, she developed a pruritic rash with vomiting and yellowing of her skin. Physical examination was notable for normal mentation, scleral icterus, jaundice, and a maculopapular rash. Initial blood workup showed international normalized ratio 2.4, alkaline phosphatase 212 U/L, ALT 3769 U/L, AST 1572 U/L and total bilirubin of 23.8 mg/ dL. Viral hepatitis serologies, chronic liver disease workup and autoimmune serologies were normal. Imaging demonstrated no intra- or extra-hepatic biliary ductal dilation. Liver biopsy showed portal inflammation with interface activity, diffuse lobular inflammation, and perivenulitis with abundant lymphocytes and plasma cells consistent with seronegative AIH or drug induced AIH. The patient developed altered mental status meeting the criteria of acute liver failure, she was started on corticosteroids as well as supportive care with resolution of encephalopathy and was discharged home on prednisone. Discussion: Several etiologies of drug-induced AIH are well-established, however cases secondary to COVID-19 vaccination have been minimally reported. Common adverse events for COVID-19 vaccination have been noted such as fever, chills, fatigue, headache, and muscle pain. Several rare side effects have occurred including immune thrombocytopenia and one other suspected case of Pfizer- BioNTech COVID-19 vaccination-induced AIH reported in the literature. In that case the patient developed symptoms within one week of the first dose. This case serves to report a potential association and not necessarily causation between the Pfizer-BioNTech COVID-19 vaccination and AIH.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event autoimmune hepatitis and the suspect drug BNT162B2 cannot be excluded. The case will be reassessed once new information is available.