chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 69 patients had recieved expired vaccine / Dose administered after 30 day use by date; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine / Dose administered after 30 day use by date) in a 22-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 07-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine / Dose administered after 30 day use by date). On 07-Jan-2022, EXPIRED PRODUCT ADMINISTERED (69 patients had recieved expired vaccine / Dose administered after 30 day use by date) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided. Reported that This lot was shipped on 12/6/2021 and the new expiration date should have been 1/5/2022 due to the refrigeration of the vaccine.  The error was caught on 1/11/2022 when a new shipment was received.
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Hypoaesthesia, Paraesthesia
Clinical narrative: tingling; numb/numbness; dizziness/dizziness for 0.5 hour after the shot.; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling), HYPOAESTHESIA (numb/numbness) and DIZZINESS (dizziness/dizziness for 0.5 hour after the shot.) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 068H21A, 025B21A and 047A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2022, the patient experienced PARAESTHESIA (tingling), HYPOAESTHESIA (numb/numbness) and DIZZINESS (dizziness/dizziness for 0.5 hour after the shot.). On 13-Jan-2022, PARAESTHESIA (tingling), HYPOAESTHESIA (numb/numbness) and DIZZINESS (dizziness/dizziness for 0.5 hour after the shot.) had resolved.            It was reported that patient did not had any medication for symptom relief. Has no medical conditions and takes no medications.
Sex: U
Vaccine: COVID19
Symptoms: Rash, Swelling
Clinical narrative: some swelling /kinda looks like I got bit by a giant mosquito; a rash; This spontaneous case was reported by an other health care professional and describes the occurrence of SWELLING (some swelling /kinda looks like I got bit by a giant mosquito) and RASH (a rash) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (some swelling /kinda looks like I got bit by a giant mosquito) and RASH (a rash). At the time of the report, SWELLING (some swelling /kinda looks like I got bit by a giant mosquito) and RASH (a rash) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment drugs were reported.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Immunisation
Clinical narrative: booster dose; back pain; 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) (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 (1st dose), for COVID-19 immunisation; Bnt162b2 (2nd dose), for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster dose"; BACK PAIN (non-serious), outcome "unknown", described as "back pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Vaccination site pain
Clinical narrative: headache; tiredness and fatigue; soreness in his arm; pain injection site; This is a spontaneous report received from a contactable consumer from medical information team. The reporter is the patient.   A male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administered in arm, administration date 05Oct2021 (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, Batch/Lot number: unknown), for COVID-19 immunisation, reactions: "fatigue/ tiredness", "headache", "muscle pain", "pain at the injection site"; BNT162B2 (dose 2, Batch/Lot number: unknown), for COVID-19 immunisation, reactions: "fatigue/ tiredness", "headache", "muscle pain", "pain at the injection site". The following information was reported: HEADACHE (non-serious) with onset 06Oct2021, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset 06Oct2021, outcome "unknown", described as "tiredness and fatigue"; PAIN IN EXTREMITY (non-serious) with onset 06Oct2021, outcome "unknown", described as "soreness in his arm"; VACCINATION SITE PAIN (non-serious) with onset 06Oct2021, outcome "unknown", described as "pain injection site".  Additional information: The reporter stated that he didn't even feel it when the provider gave him the shot (booster) and he felt like he didn't even get the shot. He didn't feel anything; his arm didn't even hurt. Then the morning after the 3rd dose, he noticed some of the same side effects as last time (previous vaccinations).   Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Myalgia, Vaccination site pain
Clinical narrative: headache; fatigue; muscle pain; pain at the injection site; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; FATIGUE (non-serious), outcome "unknown", described as "fatigue"; MYALGIA (non-serious), outcome "unknown", described as "muscle pain"; VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "pain at the injection site".  Additional Information: The patient experienced the events 2-3 hours after receiving her first and second Pfizer Covid vaccines. The reporter (patient's husband) mentioned that the patient had her booster dose on 05Oct2021 and didn't feel anything.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: pain/sore in the injection site; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 69-year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Sep2021 (Batch/Lot number: unknown) at the age of 69 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "not recovered", described as "pain/sore in the injection site". Additional information: The patient reported that her arm was sore after the first dose, clarified that it lasted for days and now her arm is sore again at the injection site of the first dose and felt like she has taken it again. The patient wanted to know if it feels that way for her to be able to get the second dose.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Insomnia, Mobility decreased, Muscle spasms, Pain in extremity
Clinical narrative: tingling; pain in ankle and hands; pain in ankle and hands; not able to move due to muscle spasm; not able to move due to muscle spasm; didn't sleep and never felt sleepy; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 06Oct2021 (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, manufacturer unknown), for COVID-19 immunisation, reaction: "no adverse effect"; COVID-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunisation, reaction: "no adverse effect". The following information was reported: INSOMNIA (non-serious) with onset 07Oct2021, outcome "unknown", described as "didn't sleep and never felt sleepy"; PARAESTHESIA (non-serious) with onset 08Oct2021, outcome "unknown", described as "tingling"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 08Oct2021, outcome "unknown" and all described as "pain in ankle and hands"; MUSCLE SPASMS (non-serious), MOBILITY DECREASED (non-serious) all with onset 08Oct2021, outcome "unknown" and all described as "not able to move due to muscle spasm".  Additional information: The patient stated that this was the foreign medicine in the patient's body. The patient never had any reactions to needles to inoculation but this was the first time the patient ever had any kind of a reaction from inoculation.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Paraesthesia
Clinical narrative: tingling; pain in ankle and hands; pain in ankle and hands; not able to move due to muscle spasm; not able to move due to muscle spasm; didn't sleep and never felt sleepy; This is a spontaneous report received from a contactable consumer. The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, Solution for injection), administration date 06Oct2021 (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, manufacturer unknown), for COVID-19 immunisation, reaction: "no adverse effect"; COVID-19 vaccine (dose 2, manufacturer unknown), for COVID-19 immunisation, reaction: "no adverse effect". The following information was reported: INSOMNIA (non-serious) with onset 07Oct2021, outcome "unknown", described as "didn't sleep and never felt sleepy"; PARAESTHESIA (non-serious) with onset 08Oct2021, outcome "unknown", described as "tingling"; ARTHRALGIA (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 08Oct2021, outcome "unknown" and all described as "pain in ankle and hands"; MUSCLE SPASMS (non-serious), MOBILITY DECREASED (non-serious) all with onset 08Oct2021, outcome "unknown" and all described as "not able to move due to muscle spasm".  Additional information: The patient stated that this was the foreign medicine in the patient's body. The patient never had any reactions to needles to inoculation but this was the first time the patient ever had any kind of a reaction from inoculation.  Follow-up attempts completed; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling
Clinical narrative: I had this swelling under my arm like half of the avocado; the right arm/today I'm getting swelling under that arm; left arm; Pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date Oct2021 (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 immunisation, reaction(s): "No any reaction from the first two"; Bnt162b2 (dose 2), for COVID-19 immunisation, reaction(s): "No any reaction from the first two".  The following information was reported: PERIPHERAL SWELLING (non-serious) with onset Oct2021, outcome "unknown", described as "I had this swelling under my arm like half of the avocado; the right arm/today I'm getting swelling under that arm; left arm"; PAIN (non-serious) with onset Oct2021, outcome "unknown", described as "Pain".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Body temperature, Immunisation, Myalgia, Pharyngeal inflammation
Clinical narrative: High fever by 37.9 degrees; Some inflammation in my throat; Muscle pain; I feel physically weak now; I got the third shot of Pfizer COVID-19; 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 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 07Oct2021 14:00 (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), administration date: Apr2021, for Covid-19 immunization; Bnt162b2 (Dose 2), administration date: Apr2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Oct2021 14:00, outcome "unknown", described as "I got the third shot of Pfizer COVID-19"; PYREXIA (non-serious) with onset 08Oct2021, outcome "unknown", described as "High fever by 37.9 degrees"; PHARYNGEAL INFLAMMATION (non-serious) with onset 08Oct2021, outcome "unknown", described as "Some inflammation in my throat"; MYALGIA (non-serious) with onset 08Oct2021, outcome "unknown", described as "Muscle pain"; ASTHENIA (non-serious) with onset 08Oct2021, outcome "not recovered", described as "I feel physically weak now". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient claims to have experienced serious side effects/problems and was asking for advice.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: High fever by 37.9 degrees; Some inflammation in my throat; Muscle pain; I feel physically weak now; I got the third shot of Pfizer COVID-19; 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 (PFIZER-BIONTECH COVID-19 VACCINE, solution for injection), administration date 07Oct2021 14:00 (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), administration date: Apr2021, for Covid-19 immunization; Bnt162b2 (Dose 2), administration date: Apr2021, for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Oct2021 14:00, outcome "unknown", described as "I got the third shot of Pfizer COVID-19"; PYREXIA (non-serious) with onset 08Oct2021, outcome "unknown", described as "High fever by 37.9 degrees"; PHARYNGEAL INFLAMMATION (non-serious) with onset 08Oct2021, outcome "unknown", described as "Some inflammation in my throat"; MYALGIA (non-serious) with onset 08Oct2021, outcome "unknown", described as "Muscle pain"; ASTHENIA (non-serious) with onset 08Oct2021, outcome "not recovered", described as "I feel physically weak now". Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient claims to have experienced serious side effects/problems and was asking for advice.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: had a sore arm; This is a spontaneous report received from contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 74 year-old female patient received bnt162b2 (BNT162B2), administration date 02Mar2021 (Lot number: EM9810) at the age of 74 years as dose 2, single and administration date 09Feb2021 (Lot number: EM9810) as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LISINOPRIL taken for hypertension. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "had a sore arm".
Sex: F
Vaccine: COVID19
Symptoms: Postmenopausal haemorrhage
Clinical narrative: vaginal bleeding heavy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administration date Sep2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation, administered at Pharmacy or Drug Store.  Relevant medical history included: "I have not had my period in more than 2 years." (unspecified if ongoing), notes: I have not had my period in more than 2 years. Prior to vaccination, the patient was not diagnosed with COVID-19. There were no concomitant medications within 2 weeks of vaccination. Past drug history included: Codeine, reaction(s): "Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: Sep2021, when the patient was 54 years old, for Covid-19 Immunization, reaction(s): "Swelling of breast lymph nodes". The patient has not received any other vaccines within 4 weeks prior to the COVID vaccine. The following information was reported: POSTMENOPAUSAL HAEMORRHAGE (medically significant) with onset Sep2021, outcome "recovered" (2021), described as "vaginal bleeding heavy". The event "vaginal bleeding heavy" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of postmenopausal haemorrhage. The clinical course of events was as follows: Swelling of breast lymph nodes after first shot - left breast so much had to reschedule a breast exam. After second shot a week after she experienced vaginal bleeding heavy at times up to 10 days.  She had not had her period in more than 2 years. Since the vaccination, the patient has not been tested for COVID-19. The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Burning sensation, Gait disturbance
Clinical narrative: Caller stated her siblings experienced the same inflammatory response/inflammatory reaction specifically stating burning, back pain and difficulty walking; Caller stated her siblings experienced the same inflammatory response/inflammatory reaction specifically stating burning, back pain and difficulty walking; Caller stated her siblings experienced the same inflammatory response/inflammatory reaction specifically stating burning, back pain and difficulty walking; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 73 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 25Mar2021 (Lot number: EP7534) at the age of 73 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "multiple health challenges" (unspecified if ongoing), notes: My sister has multiple health challenges, prior. Family history included: "diabetic (Both Type 1)" (unspecified if ongoing), notes: Brother and sister who had the same response are both diabetic (Both Type 1). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Anatomical location: Left arm, Batch/Lot Number: EN6203), administration date: 04Mar2021, when the patient was 72 years old, for COVID-19 Immunization.  The following information was reported: BURNING SENSATION (non-serious), BACK PAIN (non-serious), GAIT DISTURBANCE (non-serious) all with onset 2021, outcome "unknown" and all described as "Caller stated her siblings experienced the same inflammatory response/inflammatory reaction specifically stating burning, back pain and difficulty walking".  Additional information: Patient had an inflammatory reaction specifically stating burning, back pain and difficulty walking. Patient stated the side effects are continuing 6 months later. Patient said the side effects were a functional issue affecting quality of life. Patient stated the second dose nearly incapacitated her. Patient asked if her side effects were neurological. Patient asked if they are neurological, is it going to go away. How can her HCP determine if it is long term or short term.  Patient stated her siblings experienced the same inflammatory response. Patient stated other people she has talked to experienced problems. Patient took vaccine in Public Health Clinic. No Prior vaccinations within 4 weeks. Brother and sister, who had the same response are both diabetic (Both Type 1). I am not Diabetic. Brother and I were in good health prior to the vaccine. My sister has multiple health challenges, prior.  No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Bacterial infection, Laboratory test, Pharyngitis, SARS-CoV-2 test, Vaccination site pain
Clinical narrative: Soreness at injection site; Bacterial infection; Throat infection; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 22 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 03May2021 17:00 (Lot number: EW0173) at the age of 21 years as dose 2, single and intramuscular, administered in arm left, administration date 12Apr2021 17:00 (Lot number: EW0158) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Appendectomy", start date: 2004 (unspecified if ongoing), notes: other medical history: Appendectomy in 2004. Oral herpes., Seasonal allergies.; "Oral Herpes" (unspecified if ongoing), notes: other medical history: Appendectomy in 2004. Oral herpes., Seasonal allergies.; "Seasonal allergies" (unspecified if ongoing), notes: other medical history: Appendectomy in 2004. Oral herpes., Seasonal allergies.; "Appendicitis", start date: 01Sep2004, stop date: 01Sep2004, notes: Appendectomy performed same day due to rupture of appendix; "COVID-19 infection", start date: 14Jan2021, stop date: 25Jan2021, notes: Symptoms began on onset date, test confirmed on 16Jan2021. Concomitant medication(s) included: MG [MAGNESIUM] taken for supplementation therapy, start date: 13Nov2021 (ongoing); ZINC taken for supplementation therapy, start date: 13Nov2021 (ongoing); ASHWAGANDHA ROOT taken for disturbance in attention, start date: 13Nov2021 (ongoing); VITAFUSION VITAMIN C taken for supplementation therapy, start date: 13Nov2021 (ongoing). The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Soreness at injection site"; BACTERIAL INFECTION (non-serious) with onset 21Oct2021, outcome "recovered" (28Oct2021), described as "Bacterial infection"; PHARYNGITIS (non-serious) with onset 21Oct2021, outcome "recovered" (28Oct2021), described as "Throat infection". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of bacterial infection, pharyngitis.  Follow-up (22Dec2021): Follow-up attempts are completed. No further information is expected.  Follow-up (04Jan2022): This is a spontaneous follow-up report received from the same contactable Other-HCP.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia
Clinical narrative: losing her hair; 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 81 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included COVID-19 (unspecified if ongoing), she and her son had Covid-19 and were hospitalized. She was hospitalized for 11 days. The patient's concomitant medications were not reported. The following information was reported ALOPECIA (non-serious), outcome recovered. Therapeutic measures were taken as a result of alopecia.  Consumer said her 53-year-old son has a genetic urea cycle enzyme defect wherein he gets seizures if his proteins get too high. He is epileptic and is only allowed to have 21 ounces of protein a day. She mentioned that her son did not know he had a protein problem until he was 32 years old. He was hospitalized because of a drug-induced coma. She said the seizure was so bad. They had his hair tested and found out that he was loaded with protein. With that, consumer wants to know how much protein is in the Pfizer-BioNTech Covid-19 Vaccine. She said her son has not yet received any of the doses, and that only she and her husband received the vaccine. She also mentioned that before she received the vaccine, she had Covid-19 and were hospitalized. She took a lot of vitamins, and it took 05 months before her hair grew back. She said this also happened to other people. NDC number of COVID-19 Vaccine was not provided. Expiry Date of COVID-19 Vaccine was not provided. Other Products was not provided. Investigation Assessment was not provided. Consumer states his conditions are from birth, but they never found out until he was 32 years old because they didn't have DNA testing when he was born. He was in a medically induced coma because he had 100 seizures. Stated they tested his hair and it showed her son was loaded with protein. Caller really wants to get her son the shots because of the virus that's going around. State every one of the shots has protein in it. Even the Johnson and Johnson.    No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected.  Follow up (13Dec2021) included this is a follow-up spontaneous report from a contactable consumer. This 81-year-old female consumer (patient) reported for herself that, other information was added in Narrative.
Sex: F
Vaccine: COVID19
Symptoms: Small fibre neuropathy
Clinical narrative: Small fiber neuropathy; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 57 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: SMALL FIBRE NEUROPATHY (non-serious), outcome "unknown", described as "Small fiber neuropathy". Additional information: This is report 2 of 2. As the caller was completing a report on behalf of himself in-regards to the Pfizer COVID vaccine, the caller mentions he went on the website. The caller states it was a 57-year-old women with the same exact symptoms he had. No further details were provided or obtained.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Hypoaesthesia, Limb discomfort, Movement disorder, Pain in extremity
Clinical narrative: constant numbing pain running down R Arm/Arm pain 50 min after Shot; constant numbing pain running down R Arm/Arm pain 50 min after Shot; Unable to lift arm high enough to put bra on without help due to Pain in my Shoulder; Unable to lift arm high enough to put bra on without help due to Pain in my Shoulder; my R Arm is Messed up; feeling of being swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious) with onset Nov2021, outcome "unknown", described as "my R Arm is Messed up"; SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "feeling of being swollen"; PAIN IN EXTREMITY (non-serious) with onset 15Nov2021, outcome "not recovered", HYPOAESTHESIA (non-serious) with onset Nov2021, outcome "unknown" and all described as "constant numbing pain running down R Arm/Arm pain 50 min after Shot"; MOVEMENT DISORDER (non-serious) with onset Nov2021, outcome "unknown", ARTHRALGIA (non-serious) with onset Nov2021, outcome "not recovered" and all described as "Unable to lift arm high enough to put bra on without help due to Pain in my Shoulder".  Additional information: Subject was patient assistance. Got Pfizer shot 1 on 15Nov2021 for fear of losing my jobs. Do not want shots. Work at home M-F. Since shot 1, patient R arm was messed up with feeling of being swollen, with constant numbing pain running down R arm. Unable to lift arm high enough to put bra on without help due to pain in shoulder. Arm pain 50 min after shot and had zero problems prior to shot. Still experiencing same level of arm and shoulder pain 4 weeks later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: constant numbing pain running down R Arm/Arm pain 50 min after Shot; constant numbing pain running down R Arm/Arm pain 50 min after Shot; Unable to lift arm high enough to put bra on without help due to Pain in my Shoulder; Unable to lift arm high enough to put bra on without help due to Pain in my Shoulder; my R Arm is Messed up; feeling of being swollen; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 15Nov2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: LIMB DISCOMFORT (non-serious) with onset Nov2021, outcome "unknown", described as "my R Arm is Messed up"; SWELLING (non-serious) with onset Nov2021, outcome "unknown", described as "feeling of being swollen"; PAIN IN EXTREMITY (non-serious) with onset 15Nov2021, outcome "not recovered", HYPOAESTHESIA (non-serious) with onset Nov2021, outcome "unknown" and all described as "constant numbing pain running down R Arm/Arm pain 50 min after Shot"; MOVEMENT DISORDER (non-serious) with onset Nov2021, outcome "unknown", ARTHRALGIA (non-serious) with onset Nov2021, outcome "not recovered" and all described as "Unable to lift arm high enough to put bra on without help due to Pain in my Shoulder".  Additional information: Subject was patient assistance. Got Pfizer shot 1 on 15Nov2021 for fear of losing my jobs. Do not want shots. Work at home M-F. Since shot 1, patient R arm was messed up with feeling of being swollen, with constant numbing pain running down R arm. Unable to lift arm high enough to put bra on without help due to pain in shoulder. Arm pain 50 min after shot and had zero problems prior to shot. Still experiencing same level of arm and shoulder pain 4 weeks later.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Illness, Insomnia, Neck pain
Clinical narrative: Both time i got very sick; Headache; My arm is still swollen and very painful; My arm is still swollen and very painful; The pain extends from my arm to my shoulder and neck; The pain extends from my arm to my shoulder and neck; Cannot sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, 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, reaction(s): "Headache", "Very sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Both time i got very sick"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "not recovered" and all described as "My arm is still swollen and very painful"; ARTHRALGIA (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "The pain extends from my arm to my shoulder and neck"; INSOMNIA (non-serious), outcome "unknown", described as "Cannot sleep". Therapeutic measures were taken as a result of headache, pain in extremity, arthralgia, neck pain.  Additional information: The patient got the second COVID-19 vaccine dose. Both time the patient got very sick. 5 days of headache and now with the second dose, 7 days later my arm was still swollen and very painful. The pain extended from my arm to my shoulder and neck. The patient already massaged it but it was useless. The patient have two babies under two and taking 6 pain killer every 5 hours to deal with the pain. The patient couldn't sleep.  No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Both time i got very sick; Headache; My arm is still swollen and very painful; My arm is still swollen and very painful; The pain extends from my arm to my shoulder and neck; The pain extends from my arm to my shoulder and neck; Cannot sleep; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2, 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, reaction(s): "Headache", "Very sick". The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "Both time i got very sick"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PERIPHERAL SWELLING (non-serious), PAIN IN EXTREMITY (non-serious), outcome "not recovered" and all described as "My arm is still swollen and very painful"; ARTHRALGIA (non-serious), NECK PAIN (non-serious), outcome "unknown" and all described as "The pain extends from my arm to my shoulder and neck"; INSOMNIA (non-serious), outcome "unknown", described as "Cannot sleep". Therapeutic measures were taken as a result of headache, pain in extremity, arthralgia, neck pain.  Additional information: The patient got the second COVID-19 vaccine dose. Both time the patient got very sick. 5 days of headache and now with the second dose, 7 days later my arm was still swollen and very painful. The pain extended from my arm to my shoulder and neck. The patient already massaged it but it was useless. The patient have two babies under two and taking 6 pain killer every 5 hours to deal with the pain. The patient couldn't sleep.  No follow-up attempts were possible; information about lot/batch number cannot be obtained. No further information was expected.
Sex: U
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: sleepy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. Other Case identifier(s): US-PFIZER INC-202101834543.  A 53-year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization; pregabalin (LYRICA) (Batch/Lot number: unknown).   The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: SOMNOLENCE (non-serious), outcome "unknown", described as "sleepy". The action taken for pregabalin was dosage reduced.  Additional information: The patient's doctor changed everything from 150 to 100 and he changed the doses because it made patient sleepy.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Whole arm was hurting; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "Whole arm was hurting".  Additional information- The patient was taking Covid 19 vaccine to prevent covid. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. There was no list of any other medications the patient received within 2 weeks of vaccination. The patient received chemotherapy 5 years ago for a duration of 1 year. No further details provided. All or most of her family members had been vaccinated for Covid and nobody had any issues other than pain at the injection site. Relevant tests was reported as none. She mentioned during the family history question of the vaccine supplemental form that they had experienced pain at the injection site. Caller declined as she states that there was too many of them, like 15 people had pain at the injection site and she attributes that to two things. A: how it was administered and B, it was a 1 inch needle. She also states that she had a friend girl who said her whole arm was hurting after getting the Pfizer Covid vaccine. She declined to fill out a safety report on her behalf as well. She wants to know if had the two doses makes her fully vaccinated or was she not considered vaccinated unless she gets the third dose. Patient's Medical History (including any illness at time of vaccination) reported as none   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Migraine, Pain in extremity
Clinical narrative: Booster; Migraine; pain in left arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team and a sales representative. The reporter is the patient.  A 47 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 09Dec2021 10:00 (Batch/Lot number: unknown) at the age of 47 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 (First dose: Date administered: 19Jan2021, Lot/NDC/Expiry: Unknown, Caller did not have CDC vaccine record card with him at time of the call., Dose: Unknown strength/volume/dose injection to he thinks the right arm at 12:00.), administration date: 19Jan2021, for covid 19 immunization; Bnt162b2 (Second dose: Date administered: 09Feb2021, Lot/NDC/Expiry: Unknown, Caller did not have CDC vaccine record card with him at time of the call., Dose: Unknown strength/volume/dose injection to he thinks the right arm at 13:30), administration date: 09Feb2021, for covid 19 immunization.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; PAIN IN EXTREMITY (non-serious) with onset 10Dec2021, outcome "recovered" (10Dec2021), described as "pain in left arm"; MIGRAINE (non-serious) with onset 11Dec2021, outcome "not recovered", described as "Migraine". Therapeutic measures were taken as a result of migraine.  Additional information: Normal pain in left arm: Recovered completely from this event within about 12 hours of onset. Migraine headaches: Onset time initially reported as about 36 hours after administration of booster dose; but later clarified as in the morning when he woke up, exact time unknown. At time of onset, he described waking up with migraine headaches, major migraine headaches. He thought initially that this event would be transient, but it's a week later and still persistent. During the day event is manageable, it doesn't bug him as much; but in bed, the migraine headaches seem to be at their worst in the mornings when he first wakes up, like when he gets up to go to the bathroom. Migraine headaches: Onset time initially reported as about 36 hours after administration of booster dose; but later clarified as in the morning when he woke up, exact time unknown. At time of onset, he described waking up with migraine headaches, major migraine headaches. He thought initially that this event would be transient, but it's a week later and still persistent. During the day event is manageable, it doesn't bug him as much; but in bed, the migraine headaches seem to be at their worst in the mornings when he first wakes up, like when he gets up to go to the bathroom.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Thrombophlebitis
Clinical narrative: Thrombophlebitis/Phlebitis of lower leg; This is a spontaneous report received from a non-contactable reporter (Consumer). The reporter is the patient.A 46 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05May2021 10:00 (Batch/Lot number: unknown) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: THROMBOPHLEBITIS (non-serious) with onset 18May2021 07:00, outcome "recovered" (2021), described as "Thrombophlebitis/Phlebitis of lower leg". The event "thrombophlebitis/phlebitis of lower leg" was evaluated at the physician office visit. Therapeutic measures were taken as a result of thrombophlebitis.Additional information: No other medical history. No known allergies.The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Aspirin treatment received for the adverse event. No hospitalization prolonged. The patient was not diagnosed with COVID-19 prior to vaccination or was not tested for COVID-19 since the vaccination. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest pain, Immunisation
Clinical narrative: Sore, painful: from left breast toward the middle of chest, heart area, was sore and painful.; Sore, painful: from left breast toward the middle of chest, heart area, was sore and painful.; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 15Nov2021 (Lot number: FH8020) at the age of 49 years as dose 3, (booster) single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLU. Vaccination history included: Bnt162b2 (Dose 1, Lot: EV or EN 6208, handwritten, Expiration: Jun2021, Site: right arm, First and Second: hospital vaccine site), administration date: 22Mar2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "mild temperature"; Bnt162b2 (Dose:2, Lot: looks like EW0150, handwritten, Expiration: Jul2021, Site: right arm, First and Second: hospital vaccine site), administration date: 12Apr2021, when the patient was 49 years old, for Covid-19 Immunization, reaction(s): "Tired", "achy". The following information was reported: IMMUNISATION (non-serious) with onset 15Nov2021, outcome "unknown", described as "booster"; BREAST PAIN (non-serious), CHEST PAIN (non-serious) all with onset 16Nov2021, outcome "recovered" (17Nov2021) and all described as "Sore, painful: from left breast toward the middle of chest, heart area, was sore and painful.".  Additional Information: AE(s) require a visit to Emergency Room and Physician Office  Follow-Up (04Jan2022): Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Antibody test, Antibody test abnormal, Headache, Pyrexia, Somnolence
Clinical narrative: fever; very bad headache; she slept for three days; If my levels are very high. Antibodies.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 65 year-old female patient received bnt162b2 (COMIRNATY), administration date 12Feb2021 (Batch/Lot number: unknown) as dose1,single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PYREXIA (non-serious), outcome "unknown", described as "fever"; HEADACHE (non-serious), outcome "unknown", described as "very bad headache"; SOMNOLENCE (non-serious), outcome "unknown", described as "she slept for three days"; ANTIBODY TEST ABNORMAL (non-serious), outcome "unknown", described as "If my levels are very high. Antibodies.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information- Patient had protein test antibody test. After she got the test run over 6000. Another test done, her number was greater than 20. >20 test result. She mentioned error. She retested month later but everything was still about high end.  The lot number for bnt162b2 was not provided and will be requested during follow up.