chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fatigue; Headache; Body Aches; Chills; Fever; Brain Fog; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 41 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: PREVACID; ASPIRIN [ACETYLSALICYLIC ACID]. Vaccination history included: Covid-19 vaccine (Primary immunization series complete; unknown manufacturer.), for COVID-19 immunization. The following information was reported: FATIGUE (non-serious), outcome "unknown", described as "Fatigue"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; PAIN (non-serious), outcome "unknown", described as "Body Aches"; CHILLS (non-serious), outcome "unknown", described as "Chills"; PYREXIA (non-serious), outcome "unknown", described as "Fever"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "Brain Fog".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 20.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Blood iron, Laboratory test
Clinical narrative: started noticing a developing bald spot that is bigger than the size of half a dollar; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 20 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 29Jul2021 (Lot number: EW0916, Expiration Date: Sep2021) at the age of 20 years as dose 2, 0.3 ml single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: IRON PILLS. Vaccination history included: Bnt162b2 (1st dose, Lot: EW0181, Expiry: Aug2021, 0.3mL by injection, Sticker also says: EUA062021.), administration date: 08Jul2021, when the patient was 20 years old, for COVID-19 immunization, reaction(s): "no adverse effect". The following information was reported: ALOPECIA (non-serious) with onset Sep2021, outcome "not recovered", described as "started noticing a developing bald spot that is bigger than the size of half a dollar". The event "started noticing a developing bald spot that is bigger than the size of half a dollar" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of alopecia.  Additional information: States that since her daughter got the vaccine in late Jul2021, got her 2nd dose 29Jul2021, she had developed a bald spot the size of a half dollar that is growing. She had visited to the doctor and they have run all kinds of tests on her. States that the doctor tested her iron level 2 weeks ago when she had the appointment, and her levels were fine. The patient noticed the bald spot the end of Sep2021, but didn't show it to the mother until Dec2021. It started out really small and now it's really big; it's rapidly worsening. Went to the doctor's office 2 weeks ago for the bald spot, but they didn't even look at it; no treatment. She goes back to the doctor again on Monday. Patient had no prior Vaccinations (within 4 weeks) prior to the first administration date of the suspect vaccine(s). The patient had no adverse event following prior vaccinations. The patient had no family Medical History.  Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Previous 2 vaccinations, no issue besides sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 50 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 15Feb2021 16:00 (Lot number: EL3248) at the age of 50 years as dose 2, single and intramuscular, administered in arm left, administration date 25Jan2021 16:00 (Lot number: EL3248) as dose 1, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Previous 2 vaccinations, no issue besides sore arm".  Additional Information: Previous 2 vaccinations no issue besides sore arm (with first two doses). She experienced slight fever, horrible headache, vomiting, Nausea which symptoms 12 hrs after injection. Had 3 days malaise, exhausted 2 other days after dose 3. She did not take a 4th vaccination. The patient did not take any other vaccine prior or within 4 week of vaccination. Her family medical history did not relevant to adverse event. She did not perform any relevant tests. Specific relevant test for thromboembolic events with thrombocytopenia were none.  No follow-up attempts are possible. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Speech disorder
Clinical narrative: After the booster, my tongue felt "different/there is a loss of feeling in part of my tongue and it has very slightly effected my speech; After the booster, my tongue felt "different/there is a loss of feeling in part of my tongue and it has very slightly effected my speech; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Oct2021 (Lot number: EW0191) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: acai berry sensitivity" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6198), administration date: 05Mar2021, when the patient was 46 years old, for Covid-19 Immunization, reaction(s): "change in smell and taste", "change in smell and taste"; Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left), administration date: 26Mar2021, when the patient was 46 years old, for Covid-19 Immunization. The following information was reported: PARAESTHESIA ORAL (non-serious), SPEECH DISORDER (non-serious), outcome "not recovered" and all described as "After the booster, my tongue felt "different/there is a loss of feeling in part of my tongue and it has very slightly effected my speech". The event "after the booster, my tongue felt "different/there is a loss of feeling in part of my tongue and it has very slightly effected my speech" and "after the booster, my tongue felt "different/there is a loss of feeling in part of my tongue and it has very slightly effected my speech" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of paraesthesia oral, speech disorder.  Additional information: About 15 minutes after the first of the three shots, she experienced a change in smell and taste. She had hoped it would go away but it has remained almost the entire year. After the booster, her tongue felt different. She realized lately that there was a loss of feeling in part of my tongue and it has very slightly effected my speech. It was tip of my tongue. The rest of her mouth was also slightly effected but she was not able to compensate by over enunciating. Patient not experienced Covid 19 before administration of vaccine and not tested positive for covid after vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got so sick; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558).  A female patient received bnt162b2 (BNT162B2) (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: ILLNESS (non-serious), outcome "unknown", described as "got so sick".  Additional information: She was calling because her daughter who has a rare blood type or disease was forced for get the Covid-19 vaccine; had the 1st shot and she got so sick (date was not specified) and is scheduled to get the 2nd dose on the 18Feb2022.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Arms sore; wrist tingling; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1 (tris), 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 "Arms sore"; PARAESTHESIA (non-serious), outcome "unknown", described as "wrist tingling".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.  Follow-up (18Mar2022): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, SARS-CoV-2 test, Vulval ulceration
Clinical narrative: Vulvar ulcers; hair loss; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 21 year-old female patient received bnt162b2 (BNT162B2) (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: VULVAL ULCERATION (non-serious), outcome "unknown", described as "Vulvar ulcers"; ALOPECIA (non-serious), outcome "unknown", described as "hair loss". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The patient was not diagnosed with COVID prior to vaccination. Patient was tested Covid post vaccination and was negative.  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, COVID19
Symptoms: Hypoaesthesia
Clinical narrative: extreme numbness on the left hand; 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 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 (Lot number: EL0142) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, NDC: unknown , LOT: EL0142 , EXP: unknown), administration date: 20Jan2021, when the patient was 49 years old, for COVID-19 immunization, reaction(s): "she felt like she was in a car accident neck down and had to Crawl to the Comfort room that lasted 2 days", "she felt like she was in a car accident neck down and had to Crawl to the Comfort room that lasted 2 days", "but every bone and everything hurt for two days", "but every bone and everything hurt for two days". The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "extreme numbness on the left hand".  Additional Information: Anatomical Location of Administration of Pfizer vaccine considered as suspect: All in left arm. The patient took no other vaccine within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200222075 Same patient/ similar drug, different AE in seperate time gap
Age: 49.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Bone pain, Discomfort, Gait disturbance, Pain
Clinical narrative: extreme numbness on the left hand; 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 50 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 11Feb2021 (Lot number: EL0142) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, NDC: unknown , LOT: EL0142 , EXP: unknown), administration date: 20Jan2021, when the patient was 49 years old, for COVID-19 immunization, reaction(s): "she felt like she was in a car accident neck down and had to Crawl to the Comfort room that lasted 2 days", "she felt like she was in a car accident neck down and had to Crawl to the Comfort room that lasted 2 days", "but every bone and everything hurt for two days", "but every bone and everything hurt for two days". The following information was reported: HYPOAESTHESIA (non-serious), outcome "unknown", described as "extreme numbness on the left hand".  Additional Information: Anatomical Location of Administration of Pfizer vaccine considered as suspect: All in left arm. The patient took no other vaccine within four weeks prior to the first administration date of the suspect vaccine.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202200222075 Same patient/ similar drug, different AE in seperate time gap
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product temperature excursion issue
Clinical narrative: Dose was in freezer 5 days too long and given accidentally; Dose was in freezer 5 days too long and given accidentally; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A 65 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid right, administration date 16Nov2021 (Lot number: 30155BA) at the age of 65 years as dose 2 (booster), single for covid-19 immunisation. Relevant medical history included: "Manufacture: Jansen/ Vaccine Name: COVID 19" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (Vaccine Name: COVID 19, Manufacture: Jansen, Batch/Lot: 1805022, Route: IM, Anatomical location: R deltoid, No. of previous dose: 0, Date: 08Mar2021), administration date: 08Mar2021, for COVID-19 immunization. The following information was reported: POOR QUALITY PRODUCT ADMINISTERED (non-serious), PRODUCT TEMPERATURE EXCURSION ISSUE (non-serious), outcome "unknown" and all described as "Dose was in freezer 5 days too long and given accidentally".  Additional information: The patient did not provide information to you regarding the reported adverse event(s) with the use of the product. Did the reporter considered Pfizer product had a casual effect to the adverse event(s) was not applicable. Vaccine administered at Military facility was no. Specific Relevant Test for thromboembolic events with thrombocytopenia was none.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: prolonged menstrual cycle; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 47 year-old female patient received bnt162b2 (COMIRNATY), administration date 26Nov2021 (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 (Primary series Manufacturer unknown), for COVID-19 Immunization. The following information was reported: OLIGOMENORRHOEA (non-serious) with onset 2021, outcome "unknown", described as "prolonged menstrual cycle".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oligomenorrhoea
Clinical narrative: Prolonged menstrual cycle; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 15 year-old female patient received bnt162b2 (COMIRNATY), administration date 10Nov2021 (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, Dose number unknown), for COVID-19 immunization. The following information was reported: OLIGOMENORRHOEA (non-serious), outcome "unknown", described as "Prolonged menstrual cycle".  Additional information: Event took place after use of product.  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
Symptoms: Dizziness
Clinical narrative: Dizziness; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): NVSC2021US176568_NS.  A 60-year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) at the age of 60 years 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: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Migraine
Clinical narrative: Had a migraine for three days; headache; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Dec2021 (Lot number: 331308A, Expiration Date: 28Feb2022) at the age of 38 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Use to get migraines quite a bit" (unspecified if ongoing), notes: The caller use to get migraines quite a bit and received Botox for this.; "Allergic to Shellfish" (ongoing), notes: The caller had the reaction when was 14 or 15 years old.; "Allergic to Iodine" (unspecified if ongoing), notes: The caller had the reaction when was 14 or 15 years old. There were no concomitant medications. Past drug history included: Botox, start date: 2020, for Migraine, notes: The caller use to get migraines quite a bit and received Botox for this. The caller hasn't had a migraine since stopped getting Botox injections. The following information was reported: MIGRAINE (non-serious) with onset 22Dec2021, outcome "recovered" (25Dec2021), described as "Had a migraine for three days"; HEADACHE (non-serious) with onset 22Dec2021, outcome "recovered" (29Dec2021), described as "headache".  Additional information: The caller used to get migraines quite a bit and received Botox for this. The last time the caller received Botox was in 2020. The caller hasn't had a migraine since stopped getting Botox injections. Then the caller got a migraine after receiving the first dose Adult Pfizer Covid Vaccine. The migraine began, 22Dec2021. The caller had a headache that lasted for a week, but the migraine was three days. The caller was completely down, no light, no sound. nothing for three days during the migraine. Additional vaccines did not administer any other vaccine on same date of the Pfizer Suspect. AE(s) did not require a visit to an emergency room or physician office. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Relevant tests were none.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: Been sick a total of 4 times; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (003110). The reporter is the patient.  A 43 year-old male patient received bnt162b2 (BNT162B2), administration date Nov2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunization. Relevant medical history included: "Cold" (unspecified if ongoing), notes: Verbatim: Cold once every 2 or 3 years; "Flu" (unspecified if ongoing), notes: Verbatim: Serious flu once every 5 or so years. The patient's concomitant medications were not reported. The following information was reported: ILLNESS (non-serious) with onset 02Feb2022, outcome "unknown", described as "Been sick a total of 4 times". Additional information: Patient was  stated that I am a healthy 43 year old male. My whole life I would get a cold once every 2 or 3 years. I would get a serious flu once every 5 or so years. Since my recent Covid-19 vaccine Nov2021 I have been sick a total of 4 times. Just recently starting on 02Feb2022.   Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Dermatitis contact
Clinical narrative: COVID Booster shot brought back poison oak rash a few weeks ago; 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.  A male patient received bnt162b2 (COMIRNATY) (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, Dose Unknown), for COVID-19 Immunization. The following information was reported: DERMATITIS CONTACT (non-serious), outcome "unknown", described as "COVID Booster shot brought back poison oak rash a few weeks ago". Additional information: COVID Booster  Rash. Do not have much information, just what was listed above. He said the booster from Pfizer. Age was reported as 60.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 53.0
Sex: U
Vaccine: COVID19
Symptoms: Bone pain, Eye pain, Headache, Pain
Clinical narrative: whole body was extreamly ache; ache felt it was in my bones; headache; Eyeballs sore/tender; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 53 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 19Jan2022 (Lot number: FJ1614) at the age of 53 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1, Time: 12:00, LOT: FJ1611, Arm right), administration date: 29Dec2021, for COVID-19 immunization, reaction(s): "Nausea", "Musculoskeletal stiffness", "Pain", "Chest discomfort", "Arthralgia", "Lymph node pain", "Lymphedenopathy". The following information was reported: PAIN (non-serious) with onset 20Jan2022 01:00, outcome "recovered" (2022), described as "whole body was extreamly ache"; BONE PAIN (non-serious) with onset 20Jan2022 01:00, outcome "recovered" (2022), described as "ache felt it was in my bones"; HEADACHE (non-serious) with onset 20Jan2022 01:00, outcome "recovered" (2022), described as "headache"; EYE PAIN (non-serious) with onset 20Jan2022 01:00, outcome "recovered" (2022), described as "Eyeballs sore/tender". Therapeutic measures were not taken as a result of pain, bone pain, headache, eye pain. Additional information: The night after the patient received the second shot and wake up at 1 am, whole body was extremely achy and the ache felt like it was in the bones not in muscles. The patient also had a headache and the eyeballs hurt, when touched the eyelid, the eyes felt tender. No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Dyskinesia, Inappropriate schedule of product administration
Clinical narrative: Uncontrolled movements that are still happening every day every 5 to 10 minutes apart; Dose Number: 1, 16Mar2021/ Dose Number:2, 04Apr2021; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 04Apr2021 15:45 (Lot number: 6203) at the age of 55 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Epilepsy" (unspecified if ongoing), notes: Controlled; "Known allergies: Penecillin" (unspecified if ongoing), notes: Known allergies: Penecillin. The patient's concomitant medications were not reported. Past drug history included: Known allergies: iodine, reaction(s): "Drug Allergy". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: 8730, Location of injection: Arm Left), administration date: 26Mar2021, when the patient was 55 years old, for COVID-19 Immunization. The following information was reported: DYSKINESIA (non-serious) with onset 01May2021, outcome "not recovered", described as "Uncontrolled movements that are still happening every day every 5 to 10 minutes apart"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 04Apr2021 15:45, outcome "unknown", described as "Dose Number: 1, 16Mar2021/ Dose Number:2, 04Apr2021". Therapeutic measures were not taken as a result of dyskinesia. Additional information: Facility where the most recent COVID-19 vaccine was administered: Other. Did the patient received any other vaccines within 4 weeks prior to the COVID vaccine: No. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No.  No follow-up attempts are possible. No further information is expected.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Headache, Pain in extremity
Clinical narrative: Sore arm; Headache; expired vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 10 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 31Jan2022 16:15 (Lot number: FK5618) at the age of 10 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: FL8095, Location of injection: Arm Left, Vaccine Administration Time: 04:15 PM), administration date: 10Jan2022, when the patient was 10 years old, for COVID-19 Immunization. The following information was reported: EXPIRED PRODUCT ADMINISTERED (non-serious) with onset 31Jan2022 16:15, outcome "unknown", described as "expired vaccine"; PAIN IN EXTREMITY (non-serious) with onset 01Feb2022, outcome "unknown", described as "Sore arm"; HEADACHE (non-serious) with onset 01Feb2022, outcome "unknown", described as "Headache". The events "expired vaccine", "sore arm" and "headache" were evaluated at the physician office visit. Therapeutic measures were taken as a result of pain in extremity, headache.  Additional information: ae treatment Tylenol. The patient was not diagnosed with COVID-19, Prior to vaccination, has not been tested for COVID, Since the vaccination, did not receive any other vaccines within 4 weeks prior to the COVID vaccine and no medication within 2 weeks of vaccination. No follow-up attempts are possible. No further information is expected.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Nausea
Clinical narrative: Chills; nausea; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 36 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 08Feb2022 (Lot number: 33025bd) at the age of 36 years as dose 3 (booster), single for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: Eic 1283), for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Eic 5730), for COVID-19 Immunization. The following information was reported: CHILLS (non-serious) with onset 09Feb2022, outcome "unknown", described as "Chills"; NAUSEA (non-serious) with onset 09Feb2022, outcome "unknown", described as "nausea"; FATIGUE (non-serious) with onset 09Feb2022, outcome "unknown", described as "fatigue". Therapeutic measures were taken as a result of chills, nausea, fatigue.  Additional information: The patient received Tylenol treatment for an AE. No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Bone pain, Limb discomfort, Pain, Pain in extremity, Vaccination site pain
Clinical narrative: Left arm pain at injection site; When you get the shot, it is a little sore/achiness started about a week or so after; aching in bone; His arm is aching and hurting; cannot hardly move his left arm and can't hardly reach his back; 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.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 06Apr2021 10:00 (Lot number: EW0151) at the age of 65 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: takes a high blood pressure pill , he was taking this prior to getting the vaccines. There were no concomitant medications. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 06Apr2021, outcome "not recovered", described as "Left arm pain at injection site"; PAIN (non-serious) with onset 2021, outcome "unknown", described as "When you get the shot, it is a little sore/achiness started about a week or so after"; BONE PAIN (non-serious) with onset 2021, outcome "unknown", described as "aching in bone"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "His arm is aching and hurting"; LIMB DISCOMFORT (non-serious) with onset 2021, outcome "unknown", described as "cannot hardly move his left arm and can't hardly reach his back". No follow-up attempts are possible. No further information is expected. Follow-Up (11Feb2022): Follow-up attempts are completed. No further information is expected.
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Arthropathy
Clinical narrative: My right arm where I recieved the injection the joint feels as if the joint is bone on bone; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 59 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03May2021 09:00 (Lot number: EWO172) at the age of 59 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EWO162, Location of injection: Arm Left, Vaccine Administration Time: 09:00 AM), administration date: 12Apr2021, when the patient was 59 years old, for COVID-19 immunization. The following information was reported: ARTHROPATHY (non-serious) with onset 13Jan2022 09:00, outcome "not recovered", described as "My right arm where I recieved the injection the joint feels as if the joint is bone on bone". Therapeutic measures were not taken as a result of arthropathy.   Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine:No. Reported Event: My right arm where I recieved the injection the joint feels as if the joint is bone on bone. Prior to vaccination, was the patient diagnosed with COVID-19?:No. Since the vaccination, has the patient been tested for COVID-19?:No. Device Date : 09Feb2022.   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Movement disorder
Clinical narrative: The pain prevent you from sitting. You can lie down but with very limited movement; Excruciating lower back 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 (BNT162B2), administered in arm right, administration date 23Feb2021 17:00 (Lot number: EN6202) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Lot/Batch number: EL9203 n 9263, Time of vaccination: 19:00, Anatomical location: Right arm, Dose no: 1), administration date: 31Jan2021, for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious) with onset 23Feb2021 06:00, outcome "recovered" (20Mar2021), described as "Excruciating lower back pain"; MOVEMENT DISORDER (non-serious), outcome "unknown", described as "The pain prevent you from sitting. You can lie down but with very limited movement". Therapeutic measures were not taken as a result of back pain.  Additional Information: Pfizer/BioNTech COVID-19 Vaccine Details: Dose no: 3, Lot/Batch number: FF2590, start date: 14Oct2021, Time of vaccination (24 hrs): 11:00, Arm left, patient age was 73.  Case narrative: Excruciating lower back pain after the 2nd shot and after the booster shot. Took about 5 weeks to recover from 2nd shot. Took 3 weeks to recover from booster shot. The pain prevents you from sitting you lie down but with very limited movement. After the booster shot, patient felt dizzy for a few hours.  Follow-up attempts are completed. No further information is expected.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I have an interesting benefit; 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 68 year-old patient received bnt162b2 (BNT162B2), administered in arm, administration date 30Sep2021 (Lot number: EW0182) as dose 3 (booster), single, administered in arm, administration date 26Feb2021 (Lot number: EN6203) as dose 2, single and administered in arm, administration date 05Feb2021 (Lot number: EM9809) as dose 1, single for covid-19 immunization.   Relevant medical history included: "Menopause" (unspecified if ongoing). Concomitant medication(s) included: ESTRADIOL taken for menopause (ongoing); PROVERA taken for menopause (ongoing).  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious), outcome "unknown", described as "I have an interesting benefit".  Additional information: The patient had been plagued by cold sores on mouth and in his/her nose for years during change of season, any stressful events, and especially during the winter months. The patient had purchase an arsenal of products to help through the upcoming cold months. In addition, patient had supplies of antiviral drugs, creams, and lip balms, Patient changed diet to never, never, never eat peanut butter, which although I love, I know can activate my cold sore issues. I have not eaten peanut butter for years.   No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, Dizziness, Dysstasia, Fatigue, Feeling abnormal
Clinical narrative: stomachache; dizziness; not puking but feels woozy; having trouble in standing up and sitting down; Caller added he felt kind of funny; Sick; shakiness; tiredness; Headache; 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 54 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 10Feb2022 09:00 (Lot number: FK9729) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "one of his kidneys not functioning right" (ongoing), notes: Verbatim: one of his kidneys not functioning right. Concomitant medication(s) included: TAMSULOSIN taken for urinary tract disorder, start date: 2021. Vaccination history included: Bnt162b2 (Dose:01), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (Dose: 02), administration date: 2021, for COVID-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 10Feb2022, outcome "not recovered", described as "stomachache"; DIZZINESS (non-serious) with onset 10Feb2022, outcome "not recovered", described as "dizziness; not puking but feels woozy"; DYSSTASIA (non-serious) with onset 10Feb2022, outcome "not recovered", described as "having trouble in standing up and sitting down"; FEELING ABNORMAL (non-serious) with onset 10Feb2022, outcome "not recovered", described as "Caller added he felt kind of funny"; TREMOR (non-serious) with onset 10Feb2022, outcome "not recovered", described as "shakiness"; FATIGUE (non-serious) with onset 10Feb2022, outcome "not recovered", described as "tiredness"; HEADACHE (non-serious) with onset 10Feb2022, outcome "not recovered", described as "Headache"; ILLNESS (non-serious) with onset 10Feb2022, outcome "not recovered", described as "Sick".  Additional information included: Patient's one of his kidneys was not functioning right and he has no idea when that medical condition began. The side effects did not start right away and began at 11:00am or after 11:00am.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Illness, Tremor
Clinical narrative: stomachache; dizziness; not puking but feels woozy; having trouble in standing up and sitting down; Caller added he felt kind of funny; Sick; shakiness; tiredness; Headache; 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 54 year-old male patient received bnt162b2 (BNT162B2), administered in deltoid left, administration date 10Feb2022 09:00 (Lot number: FK9729) at the age of 54 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "one of his kidneys not functioning right" (ongoing), notes: Verbatim: one of his kidneys not functioning right. Concomitant medication(s) included: TAMSULOSIN taken for urinary tract disorder, start date: 2021. Vaccination history included: Bnt162b2 (Dose:01), administration date: 2021, for COVID-19 Immunization; Bnt162b2 (Dose: 02), administration date: 2021, for COVID-19 Immunization. The following information was reported: ABDOMINAL PAIN UPPER (non-serious) with onset 10Feb2022, outcome "not recovered", described as "stomachache"; DIZZINESS (non-serious) with onset 10Feb2022, outcome "not recovered", described as "dizziness; not puking but feels woozy"; DYSSTASIA (non-serious) with onset 10Feb2022, outcome "not recovered", described as "having trouble in standing up and sitting down"; FEELING ABNORMAL (non-serious) with onset 10Feb2022, outcome "not recovered", described as "Caller added he felt kind of funny"; TREMOR (non-serious) with onset 10Feb2022, outcome "not recovered", described as "shakiness"; FATIGUE (non-serious) with onset 10Feb2022, outcome "not recovered", described as "tiredness"; HEADACHE (non-serious) with onset 10Feb2022, outcome "not recovered", described as "Headache"; ILLNESS (non-serious) with onset 10Feb2022, outcome "not recovered", described as "Sick".  Additional information included: Patient's one of his kidneys was not functioning right and he has no idea when that medical condition began. The side effects did not start right away and began at 11:00am or after 11:00am.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Hunger, Sluggishness
Clinical narrative: Sluggish; Tired; Hungry; 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 39 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single, (Batch/Lot number: unknown) as dose 2, single and (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: SLUGGISHNESS (non-serious), outcome "unknown", described as "Sluggish"; FATIGUE (non-serious), outcome "unknown", described as "Tired"; HUNGER (non-serious), outcome "unknown", described as "Hungry". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Feeling abnormal, Ultrasound Doppler
Clinical narrative: dizzy/ Lightheaded; grey; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 43 year-old female patient received bnt162b2 (BNT162B2), administration date 29Dec2020 (Lot number: EL0140, Expiration Date: Mar2021) at the age of 42 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Fibromyalgia" (ongoing), notes: Verbatim: Fibromyalgia; "Urticaria" (ongoing), notes: Verbatim: Urticaria, Since 5-6 Year of Age; "Raynaud's disease" (ongoing), notes: Verbatim: Raynaud''s disease; "Tested positive for markers for Scleroderma" (ongoing), notes: Verbatim: Tested positive for markers for Scleroderma; "Rash from really hot shower or really constrictive clothes gets hives" (unspecified if ongoing), notes: AE(s) following prior vaccinations: Rash from really hot shower or really constrictive clothes gets hives.; "Rash from really hot shower or really constrictive clothes gets hives" (unspecified if ongoing), notes: AE(s) following prior vaccinations: Rash from really hot shower or really constrictive clothes gets hives. . There were no concomitant medications. Vaccination history included: Flu (Flu Vaccine; Rash and Got flu 3 times that year. Doesn't always happen , Onset Age: 30s NDC, Lot, Expiration: Unknown), for Immunization, reaction(s): "Rash". The following information was reported: DIZZINESS (non-serious) with onset 29Dec2020, outcome "recovered" (29Dec2020), described as "dizzy/ Lightheaded"; FEELING ABNORMAL (non-serious) with onset 29Dec2020, outcome "recovered" (29Dec2020), described as "grey". Relevant laboratory tests and procedures are available in the appropriate section.  Follow-up attempts completed. No further information expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Irritability, Loss of personal independence in daily activities, Pain
Clinical narrative: wasn't able to stay awake, that she was tired all the time/really tired all the time and really cranky tired; aching; irritable; it is affecting her work; 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 Jan2022 (Lot number: FJ1614) 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: FATIGUE (non-serious) with onset 2022, outcome "unknown", described as "wasn't able to stay awake, that she was tired all the time/really tired all the time and really cranky tired"; PAIN (non-serious) with onset 2022, outcome "unknown", described as "aching"; IRRITABILITY (non-serious) with onset 2022, outcome "unknown", described as "irritable"; LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (non-serious) with onset 2022, outcome "unknown", described as "it is affecting her work".  Additional information: Reporter states she was calling about the Pfizer Vaccine and was really tired all the time and really cranky tired and just got the vaccine a week ago and couldn't even stay awake on the job and has an evening job and it is affecting her work.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Dysstasia
Clinical narrative: Dizziness; Difficulty standing; TThis is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): LRN4546313.  A 46 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. Relevant medical history included: "Multiple sclerosis" (unspecified if ongoing); "Eye shaking" (unspecified if ongoing), notes: Eye shaking; "Confusion" (ongoing); "Hand Tremors" (ongoing), notes: Hand Tremors; "Dizziness" (ongoing); "Difficulty standing" (ongoing), notes: Difficulty standing; "Unstable" (ongoing), notes: Unstable; "Buzzing" (ongoing), notes: Buzzing. The patient's concomitant medications were not reported. The following information was reported: DIZZINESS (non-serious), outcome "unknown", described as "Dizziness"; DYSSTASIA (non-serious), outcome "unknown", described as "Difficulty standing".  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: Blood test, Blood test abnormal
Clinical narrative: Caller says his wife's blood tests were up, until the booster vaccine.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 75 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 05Apr2021 (Lot number: EP7533) at the age of 74 years as dose 2, single and administered in arm left, administration date 15Mar2021 (Lot number: EP6955) as dose 1, single for covid-19 immunisation. Relevant medical history included: "ITP", start date: 2017 (unspecified if ongoing), notes: ITP, this was diagnosed four years ago, before she got the vaccines. There were no concomitant medications. The following information was reported: BLOOD TEST ABNORMAL (non-serious) with onset 2021, outcome "unknown", described as "Caller says his wife's blood tests were up, until the booster vaccine.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The reporter said that his wife got the vaccine because of COVID, clarified to her did not have COVID, she got it to prevent COVID. Her blood tests were up, until the booster vaccine and they seemed really, good and she had one a year apart, when they tanked.  No follow-up attempts are possible. No further information is expected.  Follow-Up (15Feb2022): Follow-up attempts are completed. No further information is expected.