chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: Suffered aches for 36 hours post 3rd (booster) shot; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male 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 (Dose: 2), when the patient was 51 years old, for Covid-19 immunization; Bnt162b2 (Dose: 1), when the patient was 51 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Suffered aches for 36 hours post 3rd (booster) shot".  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: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Heart rate, Heart rate increased, Oral mucosal blistering, Vaccination site pain
Clinical narrative: Sore arm at injection site; High resting heart rate (just over 100, normal heart rate is round 60); Blisters in mouth; Fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 30Oct2021 14:15 (Batch/Lot number: unknown) at the age of 28 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Major depressive disorder" (unspecified if ongoing); "generalized anxiety disorder" (unspecified if ongoing); "bursitis of hips" (unspecified if ongoing); "PTSD" (unspecified if ongoing). Concomitant medication(s) included: SERTRALINE. Vaccination history included: Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer ,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Misplaced/discarded,, prev dose administration date=25Mar2021, prev dose dose number=2,, prev dose vaccine location=Left arm), administration date: 25Mar2021, when the patient was 28 years old, for Covid-19 Immunization; Bnt162b2 (prev dose product=COVID 19,, prev dose brand=Pfizer ,, prev dose brand unknown=False,, prev dose lot unknown=True,, prev dose lot unknown reason=Misplaced/discarded,, prev dose administration date=04Mar2021, prev dose dose number=1,, prev dose vaccine location=Left arm), administration date: 04Mar2021, when the patient was 28 years old, for Covid-19 Immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 30Oct2021, outcome "not recovered", described as "Sore arm at injection site"; HEART RATE INCREASED (non-serious) with onset 30Oct2021, outcome "not recovered", described as "High resting heart rate (just over 100, normal heart rate is round 60)"; ORAL MUCOSAL BLISTERING (non-serious) with onset 30Oct2021, outcome "not recovered", described as "Blisters in mouth"; FATIGUE (non-serious) with onset 30Oct2021, outcome "not recovered", described as "Fatigue". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of vaccination site pain, heart rate increased, oral mucosal blistering, fatigue.  Additional information: The patient not had COVID prior vaccination. The patient was not tested for COVID post vaccination. Patient had no known allergies.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain
Clinical narrative: I got the Pfizer covid vaccine I am experiencing mild to moderate chest pain getting elevated sometimes; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 48 year-old male patient received bnt162b2 (BNT162B2), administration date 25Oct2021 (Batch/Lot number: unknown) at the age of 48 years 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: CHEST PAIN (non-serious) with onset 25Oct2021 16:00, outcome "not recovered", described as "I got the Pfizer covid vaccine I am experiencing mild to moderate chest pain getting elevated sometimes". Therapeutic measures were not taken as a result of chest pain.  Additional information: Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. No other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Reported Event: From the time patient got the Pfizer covid vaccine patient had experienced mild to moderate chest pain which was getting elevated sometimes. Pt never had chest pains before in life. Reaction: Allergy. Known allergies: No. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. Device Date: 01Nov2021.  The lot number for the vaccine, [BNT162B2], was not provided and will be requested during follow up.  Follow-up (03Dec2021): 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.  No follow-up attempts are possible. No further information is expected.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Menstruation delayed
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient. A 25 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 24Sep2021 (Lot number: FF2589) at the age of 25 years as dose 2, single and intramuscular, administered in arm left, administration date 02Sep2021 (Lot number: FF2588) as dose 1, single for Covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: SPIRONOLACTONE; PRENATAL VITAMINS [ASCORBIC ACID; BETACAROTENE; CALCIUM SULFATE; COLECALCIFEROL; CYANOCOBALAMIN; FERROUS FUMARATE;- FOLIC ACID; NICOTINAMIDE; PYRIDOXINE HYDROCHLORIDE; RETINOL ACETATE; RIBOFLAVIN; THIAMINE MONONITRATE; TOCOPHERYL ACETATE; ZINC OXIDE]. The following information was reported: MENSTRUATION DELAYED (non-serious) with onset 05Sep2021, outcome "not recovered", described as "After first vaccine received on 02Sep menstrual cycle was supposed to start on 05Sep. Started on 17Sep. After second dose received on 24Sep menstrual cycle was supposed to start on 27Oct". Therapeutic measures were not taken as a result of menstruation delayed. Additional information: Facility type vaccine: Pharmacy or Drug Store. No other vaccine in four weeks. After first vaccine received on 02Sep menstrual cycle was supposed to start on 05Sep. Started on 17Sep. After second dose received on 24Sep menstrual cycle was supposed to start on 27Oct. No Covid prior vaccination. No Covid tested post vaccination. Allergies: Unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Vaccination site pain
Clinical narrative: Injection site pain; Headache; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 47 year-old female patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE, Primary Immunization series complete;  unknown manufacturer), for COVID-19 Immunization. The following information was reported: VACCINATION SITE PAIN (non-serious), outcome "unknown", described as "Injection site pain"; HEADACHE (non-serious), outcome "unknown", described as "Headache"; NAUSEA (non-serious), outcome "unknown", described as "Nausea".  additional information: experiencing headache, nausea and injection site pain the day after receiving a Pfizer Covid vaccine booster.   the lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Disturbance in sexual arousal, Dizziness, Insomnia, Muscle spasms
Clinical narrative: Body aches; chills and shivering at night but no fever; Dizziness; Back and neck muscle spasms; Back and neck muscle spasms; Sleeplessness and nightmares; Sleeplessness and nightmares; Sexual arousal at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 09:30 (Lot number: 32030bd) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR. Vaccination history included: Bnt162b2 (Dose Number: 1, prev dose lot number: fc3182, prev dose vaccine location: Left Arm), administration date: Sep2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 01Nov2021 23:30, outcome "unknown", described as "Body aches"; CHILLS (non-serious) with onset 01Nov2021 23:30, outcome "unknown", described as "chills and shivering at night but no fever"; DIZZINESS (non-serious) with onset 01Nov2021 23:30, outcome "unknown", described as "Dizziness"; MUSCLE SPASMS (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious) all with onset 01Nov2021 23:30, outcome "unknown" and all described as "Back and neck muscle spasms"; INSOMNIA (non-serious), NIGHTMARE (non-serious) all with onset 01Nov2021 23:30, outcome "unknown" and all described as "Sleeplessness and nightmares"; DISTURBANCE IN SEXUAL AROUSAL (non-serious) with onset 01Nov2021 23:30, outcome "unknown", described as "Sexual arousal at night". Therapeutic measures were not taken as a result of pain, chills, dizziness, muscle spasms, musculoskeletal discomfort, insomnia, nightmare, disturbance in sexual arousal.  Additional information: Adverse event: Body aches, chills and shivering at night but no fever.Dizziness.Back and neck muscle spasms. Sleeplessness and nightmares Sexual arousal at night. Patient did not receive any other vaccine within four weeks. Patient did not test prior to COVID vaccination and post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal discomfort, Nightmare, Pain
Clinical narrative: Body aches; chills and shivering at night but no fever; Dizziness; Back and neck muscle spasms; Back and neck muscle spasms; Sleeplessness and nightmares; Sleeplessness and nightmares; Sexual arousal at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 49 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 01Nov2021 09:30 (Lot number: 32030bd) at the age of 49 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LIPITOR. Vaccination history included: Bnt162b2 (Dose Number: 1, prev dose lot number: fc3182, prev dose vaccine location: Left Arm), administration date: Sep2021, when the patient was 49 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 01Nov2021 23:30, outcome "unknown", described as "Body aches"; CHILLS (non-serious) with onset 01Nov2021 23:30, outcome "unknown", described as "chills and shivering at night but no fever"; DIZZINESS (non-serious) with onset 01Nov2021 23:30, outcome "unknown", described as "Dizziness"; MUSCLE SPASMS (non-serious), MUSCULOSKELETAL DISCOMFORT (non-serious) all with onset 01Nov2021 23:30, outcome "unknown" and all described as "Back and neck muscle spasms"; INSOMNIA (non-serious), NIGHTMARE (non-serious) all with onset 01Nov2021 23:30, outcome "unknown" and all described as "Sleeplessness and nightmares"; DISTURBANCE IN SEXUAL AROUSAL (non-serious) with onset 01Nov2021 23:30, outcome "unknown", described as "Sexual arousal at night". Therapeutic measures were not taken as a result of pain, chills, dizziness, muscle spasms, musculoskeletal discomfort, insomnia, nightmare, disturbance in sexual arousal.  Additional information: Adverse event: Body aches, chills and shivering at night but no fever.Dizziness.Back and neck muscle spasms. Sleeplessness and nightmares Sexual arousal at night. Patient did not receive any other vaccine within four weeks. Patient did not test prior to COVID vaccination and post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Nervous system disorder
Clinical narrative: had a response in her nervous system.; 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 (COMIRNATY), administration date 02Sep2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NERVOUS SYSTEM DISORDER (non-serious), outcome "unknown", described as "had a response in her nervous system.".Original INT: Call transferred by (name) from agency, NTID: #, Reportum: #. Caller had the first dose of the Pfizer-BioNTech COVID-19 Vaccine on 02Sep2021 and had a response in her nervous system. She has very little primary healthcare but have alternative medicine HCP instead. She barely take antibiotics or any medications. She is asking if there are different variety of dosage for the vaccine for people over 65 years old as she is concerned on the dosage she received.  Follow-up (05Nov2021): This is a follow-up spontaneous report from a contactable consumer. This consumer reported in response to consumer letter sent to consumer via telephonic follow-up activity which included that: Phone-Out 12:45 PM, 1st attempt by phone to consumer to obtain mailing information. Phone answered by consumer who did not provide her e-mail address instead provided her mailing address.  Follow-up (13Dec2021): This follow-up is being submitted to notify that the lot/batch number is not available despite the follow-up attempts made.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: Eczema flare up from just a spot on my hand to my torso and legs and arms; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Oct2021 14:00 (Lot number: FF2589) at the age of 23 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "allergies" (unspecified if ongoing); "MTHFR gene mutation" (unspecified if ongoing); "covid-19" (unspecified if ongoing), notes: if covid prior vaccination- Yes; "eczema" (unspecified if ongoing). Concomitant medication(s) included: MONTELUKAST; FLONASE [FLUTICASONE PROPIONATE]; XYZAL; METHYL CPG. Past drug history included: Hydrocodone, reaction(s): "known allergies: hydrocodone", notes: known allergies: hydrocodone; High doses of steroids, reaction(s): "known allergies: High doses of steroids", notes: known allergies: High doses of steroids The following information was reported: ECZEMA (non-serious) with onset 20Oct2021, outcome "recovering", described as "Eczema flare up from just a spot on my hand to my torso and legs and arms". The event "eczema flare up from just a spot on my hand to my torso and legs and arms" was evaluated at the physician office visit. Therapeutic measures were taken as a result of eczema.  Additional information: Dose received: 2, product: COVID 19, Brand: Pfizer, brand unknown:False, lot number: 30135BA, lot unknown: False, administration date:25Oct2021, administration time:03:30 PM, dose number:2, vaccine location: Right arm. The patient did not receive any other vaccines within four weeks prior to the vaccination. AE resulted in Doctor or other healthcare professional office/clinic visit. Treatment received as Triamcinolone Acetonide Cream 0.025%. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity
Clinical narrative: Swollen lymph nodes under left arm; Painful and noticeably swollen compared to area under right arm; This is a spontaneous report from a contactable consumer. This 40-year-old female consumer (patient) reported for herself that:   Serious: (NO)     Seriousness criteria-Results in death: (NO)     Seriousness criteria-Life threatening: (NO)     Seriousness criteria-Caused/prolonged hospitalization: (NO)     Seriousness criteria-Disabling/Incapacitating: (NO)     Seriousness criteria-Congenital anomaly/birth defect: (NO)      Race ethnicity information available. patient occupation: None of the above  Start Date/Time: [Pfizer] 28Oct2021 12:30 PM  Location of injection for vaccine received same date: Flu Shot (Afluria Quad PF) - Right Arm  Dose received: 3 most_recent_dose_details: Product=COVID 19, brand=Pfizer, Brand unknown=False, lot number=320308D, lot unknown=False, Administration date=28Oct2021, Administration time=12:30 PM, dose_number=3, vaccine location=Left arm  Previous dose details: Prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EW0167, prev dose lot unknown=False, prev dose administration_date=29Apr2021,  prev dose dose number=2, prev dose vaccine location=Left  arm}, {prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=ER8732, prev dose lot unknown=False, prev dose administration date=01Apr2021,  prev dose dose number=1, prev dose vaccine location=Left arm  Other vaccine same date details: Other vaccine same date product= Flu Shot (Afluria Quad PF), other vaccine same date vaccine date=28Oct2021, other vaccine same date dose number=1, other vaccine same date vaccine location=Right Arm  facility type vaccine: Pharmacy or Drug Store facility name and address: Withheld  other medications in two weeks: D-Amphetamine, Escitalopram, Tri-Sprintec, Vit D  adverse event: Swollen lymph nodes under left arm. Painful and noticeably swollen compared to area under right arm. adverse event start date: 30Oct2021 adverse event country: US AE resulted in: None of the above if patient recovered: Recovered if treatment ae: No  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  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 : 02Nov2021 known allergies: no other medical history: no  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Illness, Nausea
Clinical narrative: got a little sick; Headache; very tired; Nauseous; 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 female patient received bnt162b2 (BNT162B2) (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: ILLNESS (non-serious), outcome "recovered" (2021), described as "got a little sick"; HEADACHE (non-serious), outcome "recovered" (2021), described as "Headache"; FATIGUE (non-serious), outcome "recovered" (2021), described as "very tired"; NAUSEA (non-serious), outcome "recovered" (2021), described as "Nauseous".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lacrimation increased, Pain in extremity
Clinical narrative: left arm is still sore and when she moves it it brings her to tears/her arm is so painful; left arm is still sore and when she moves it it brings her to tears; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 67 year-old female patient received bnt162b2 (BNT162B2), administration date 25Sep2021 (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 (First dose), for COVID-19 immunization, reaction(s): "she got hot and cold"; Bnt162b2 (Second dose), for COVID-19 immunization, reaction(s): "she got hot and cold". The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "not recovered", described as "left arm is still sore and when she moves it it brings her to tears/her arm is so painful"; LACRIMATION INCREASED (non-serious) with onset 2021, outcome "not recovered", described as "left arm is still sore and when she moves it it brings her to tears".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: kind of felt run down; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 17Mar2021 (Lot number: EM9810) at the age of 66 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "RA", start date: Feb2020 (ongoing); "autoimmune disorder", start date: Sep2005 (ongoing), notes: he would assume his diabetes is the autoimmune disorder; "Hairy Cell Leukemia", start date: 1992 (unspecified if ongoing), notes: he states this was the start of his problems, he had it twice, 1992 and then again JUL2005; "Hairy Cell Leukemia", start date: Jul2005 (unspecified if ongoing), notes: he states this was the start of his problems, he had it twice, 1992 and then again JUL2005; "Neuropathy" (ongoing); "bad knees" (ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (First Dose, LOT: EM9810, injection, left arm, unknown dosage, No events reported .), administration date: 19Feb2021, when the patient was 65 years old, for COVID-19 Immunization; Flu shot (After the Covid shot, it was almost exactly a month after he come out of it, that was only 2 weeks ago or something), for Immunization. The following information was reported: FEELING ABNORMAL (non-serious) with onset 18Mar2021, outcome "recovered" (20Mar2021), described as "kind of felt run down".  Additional information: Caller states he has an autoimmune system disorder and RA, both of which puts him in the high risk category so he got the third vaccination, the first one, nothing, second one, kind of felt run down for a couple days, the third almost killed him, he thinks anybody else would have been to the hospital but he didn't want to, he was down for 2 weeks and 3 days of that he doesn't even remember those days. No visits of Emergency Room and Physician Office (he called his doctor and that was about it). It was unknown if the patient had prior vaccinations within 4 weeks.   Follow-up attempts completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Disease recurrence
Clinical narrative: This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient. A female patient received bnt162b2 (BNT162B2), administration date 01Nov2021 (Batch/Lot number: unknown) as dose 3 (booster), single for Covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 1), for COVID-19 immunization; Bnt162b2 (DOSE: 2), for COVID-19 immunization. The following information was reported: BACK PAIN (non-serious), outcome "not recovered", described as "she had a bad back ache./back is sore"; DISEASE RECURRENCE (non-serious) with onset Nov2021, outcome "not recovered", described as "I am having a back ache that is something that reoccurring". Additional information: it was reported that, she received the booster dose yesterday and she had a bad back ache. Actually, she had a question. She was asking if she can take Tylenol (Suspect captured for query) and she already gave the number of our Pfizer medical information department as well". She got her booster shot yesterday, she was having a back ache that was something that reoccurring. It doesn't have anything to do with the vaccine or COVID or anything like that. It was something that reoccurs that she had. All she wanna know if she could take some Tylenol to help her back ache if it won't mess up with vaccine or anything. Her back was sore and she just want to take some aspirin (suspect captured for query) if she can. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Computerised tomogram, Headache
Clinical narrative: Headaches; 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 30 year-old female patient received bnt162b2 (COMIRNATY), administered in arm, administration date 18Aug2021 (Lot number: FA7484) at the age of 30 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "C-section", start date: 08Jan2014 (unspecified if ongoing), notes: she had 4 c-sections with spinal taps ; "Lost taste", start date: Jun2021 (unspecified if ongoing); "Lost taste and smell at the time", start date: Jun2021 (unspecified if ongoing); "Heart ablation", start date: 2017 (unspecified if ongoing), notes: She had heart ablation on 2017; "Gall Bladder removal", start date: 2017 (unspecified if ongoing), notes: She had Gallbladder removal on 2017; "C-section", start date: 30Dec2015 (unspecified if ongoing), notes: C-section done on 08Jan2014, 30Dec2015, 30Jun2018 and on 12Jun2020; "C-section", start date: 30Jun2018 (unspecified if ongoing), notes: C-section done on 08Jan2014, 30Dec2015, 30Jun2018 and on 12Jun2020; "C-section", start date: 12Jun2020 (unspecified if ongoing), notes: C-section done on 08Jan2014, 30Dec2015, 30Jun2018 and on 12Jun2020; "covid", start date: Jun2021 (unspecified if ongoing). There were no concomitant medications. The following information was reported: HEADACHE (non-serious) with onset Aug2021, outcome "not recovered", described as "Headaches". The event "headaches" was evaluated at the emergency room visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache.  Additional information: she had 4 C-sections with spinal taps which could be damaging to the nerves. C-section done on 08Jan2014, 30Dec2015, 30Jun2018 and on 12Jun2020. States they are different headaches and not the not the normal type of headache, it feels like it is her nerves. Thinks one dose was in left arm and other dose was in the right arm but she is not sure, she just knows it was in her arm. Headaches are every week, around 3 days a week, it is really intense, usually above or around temple. Treatment: patient takes Tylenol and Ibuprofen and they are not really working which is why she thinks it is a different kind of head pain. Confirmed she was not admitted. Patient stated she will follow up with doctor tomorrow since headaches are not going away.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Pain
Clinical narrative: general body ache; exhaustion; chills; 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) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Essential tremor" (unspecified if ongoing); "Allergy: walnuts" (unspecified if ongoing), notes: Mild oral allergy to walnuts &, eggplant; "Allergy: eggplant" (unspecified if ongoing), notes: Mild oral allergy to walnuts &, eggplant. Concomitant medication(s) included: ADVIL [IBUPROFEN]; ALEVE; LITHIUM; PROPRANOLOL; LEVOCETIRIZIN; FLUCELVAX QUADRIVALENT, administration date 30Oct2021. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: I don't have the number right now), when the patient was 54 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious), outcome "not recovered", described as "general body ache"; FATIGUE (non-serious), outcome "not recovered", described as "exhaustion"; CHILLS (non-serious), outcome "not recovered", described as "chills". It was unknown if therapeutic measures were taken as a result of pain, fatigue, chills.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications she received within 2 weeks of vaccination was Advil, Aleve, Lithium, Propranolol, Levoceterizine. She was not diagnosed with COVID-19 Prior to vaccination. Since the vaccination, she has been not tested for COVID-19. Device Date was 02Nov2021.  Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Antibody test, Discomfort, Pain in extremity
Clinical narrative: stated that he felt more uncomfortable with the first dose; had a sore arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP).  A male 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: DISCOMFORT (non-serious), outcome "unknown", described as "stated that he felt more uncomfortable with the first dose"; PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "had a sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: The report was not related to study or programme.  The reason for no lot number of Covid shot was that caller was unwilling to complete the report. Patient history was not provided.  Caller stated that her spouse had both Covid as advised. Stated that he had absolutely hardly any antibodies after 7 months. Stated that this is very discouraging. Stated that she read as much as could before she called and there was no guarantee of immunity. Caller stated that it stated that an antibody count of 2500 is advisable. Stated that her husband had 64. Later clarified that she did not complete a report on her husband. Stated that he had a sore arm with both doses and felt more uncomfortable after the first. Nurse declined to provide further details about the adverse reaction. She wanted to know why it does not know why it does not provide more antibodies. She stated that she worked for 30 years as nurse.  Follow-up attempts completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure fluctuation, Blood pressure measurement
Clinical narrative: experienced swings in blood pressure, like extremely low and also high blood pressure; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 80 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 and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1 (Manufacturer unknown)), for covid-19 immunisation; Covid-19 vaccine (Dose 2 (Manufacturer unknown)), for covid-19 immunisation. The following information was reported: BLOOD PRESSURE FLUCTUATION (non-serious), outcome "unknown", described as "experienced swings in blood pressure, like extremely low and also high blood pressure". Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information: The reporter and the father experienced side effect after getting the third booster shot for the vaccine. Patient experienced swings in blood pressure, like extremely low and also high blood pressure.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Lactation disorder, Off label use, Product use issue
Clinical narrative: After my second dose of the COVID vaccine my milk dried up almost completely in one day; vaccine took away my milk supply; Drug use in unapproved population; Off-label use; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 28Sep2021 07:00 (Lot number: 301458) at the age of 22 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 Number: 1, Batch/Lot No: FE3592, Location of injection: Leg Right, Vaccine Administration Time: 13:30), administration date: 07Sep2021, when the patient was 22 years old, for COVID-19 immunization, reaction(s): "After I received my first Covid dose I could only pump 5oz of milk", "dose 1, Location of injection: Leg Right". The following information was reported: LACTATION DISORDER (non-serious) with onset 29Sep2021 08:00, outcome "not recovered", described as "After my second dose of the COVID vaccine my milk dried up almost completely in one day; vaccine took away my milk supply"; PRODUCT USE ISSUE (non-serious) with onset 28Sep2021 07:00, outcome "unknown", described as "Drug use in unapproved population"; OFF LABEL USE (non-serious) with onset 28Sep2021 07:00, outcome "unknown", described as "Off-label use". Therapeutic measures were not taken as a result of lactation disorder.  Additional information- I was strictly breastfeeding my son who was born 25Mar2021. I pumped 2-3 bags of milk at work a day. After patients second dose of the COVID vaccine her milk dried up almost completely in one day.Her breast never became engorged and after 6 months of strictly breastfeeding she had to switch to formula because the vaccine took away her milk supply in one day. She tried to breastfeed after in hopes that she could increase the supply again but she had to stop trying after two weeks because the milk never came back. she planned on breastfeeding for two years and she was very good at pumping and supplying her son with plenty of milk.  Follow-up attempts are completed. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Feeling abnormal, Headache, Nasal congestion
Clinical narrative: body aches; nasal congestion; dazedness; chills; headache; arm pain; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 03Nov2021 18:15 (Lot number: FD0810) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 14Oct2021; PANTOPRAZOLE; CARAFATE; MILK THISTLE; D3; B12-VITAMIIN. Past drug history included: Tetracycline, reaction(s): "allergies". Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EW0169, Location of injection: Arm Right), administration date: 16Apr2021, when the patient was 31 years old, for COVID-19 Immunization; Bnt162b2 (Dose 2, Batch/Lot No: EW0183, Location of injection: Arm Right, Vaccine Administration Time: 10:15 AM), administration date: 08May2021, when the patient was 31 years old, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 03Nov2021, outcome "recovering", described as "body aches"; NASAL CONGESTION (non-serious) with onset 03Nov2021, outcome "recovering", described as "nasal congestion"; FEELING ABNORMAL (non-serious) with onset 03Nov2021, outcome "recovering", described as "dazedness"; CHILLS (non-serious) with onset 03Nov2021, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 03Nov2021, outcome "recovering", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 03Nov2021, outcome "recovering", described as "arm pain"; FATIGUE (non-serious) with onset 03Nov2021, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of pain, nasal congestion, feeling abnormal, chills, headache, pain in extremity, fatigue.  Additional information: The patient did receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pain in extremity
Clinical narrative: body aches; nasal congestion; dazedness; chills; headache; arm pain; fatigue; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 31 year-old female patient (not pregnant) received bnt162b2 (COMIRNATY), administered in arm right, administration date 03Nov2021 18:15 (Lot number: FD0810) at the age of 31 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 14Oct2021; PANTOPRAZOLE; CARAFATE; MILK THISTLE; D3; B12-VITAMIIN. Past drug history included: Tetracycline, reaction(s): "allergies". Vaccination history included: Bnt162b2 (Dose 1, Batch/Lot No: EW0169, Location of injection: Arm Right), administration date: 16Apr2021, when the patient was 31 years old, for COVID-19 Immunization; Bnt162b2 (Dose 2, Batch/Lot No: EW0183, Location of injection: Arm Right, Vaccine Administration Time: 10:15 AM), administration date: 08May2021, when the patient was 31 years old, for COVID-19 Immunization. The following information was reported: PAIN (non-serious) with onset 03Nov2021, outcome "recovering", described as "body aches"; NASAL CONGESTION (non-serious) with onset 03Nov2021, outcome "recovering", described as "nasal congestion"; FEELING ABNORMAL (non-serious) with onset 03Nov2021, outcome "recovering", described as "dazedness"; CHILLS (non-serious) with onset 03Nov2021, outcome "recovering", described as "chills"; HEADACHE (non-serious) with onset 03Nov2021, outcome "recovering", described as "headache"; PAIN IN EXTREMITY (non-serious) with onset 03Nov2021, outcome "recovering", described as "arm pain"; FATIGUE (non-serious) with onset 03Nov2021, outcome "recovering", described as "fatigue". Therapeutic measures were not taken as a result of pain, nasal congestion, feeling abnormal, chills, headache, pain in extremity, fatigue.  Additional information: The patient did receive other vaccine in four weeks. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Heavy arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A patient (no qualifiers provided) received bnt162b2 (COMIRNATY), administration date 2021 (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 2021, outcome "not recovered", described as "Heavy arm".  Additional information: Heavy arm after first dose and still that way 4 months later.  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: Fatigue, Headache, Somnolence
Clinical narrative: First dose: sleepy; Headache; Tired; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program (159558). The reporter is the patient.  A 69 year-old female patient received bnt162b2 (COMIRNATY), administration date 22Mar2021 (Lot number: EN6202) at the age of 69 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Covid", start date: Dec2020 (unspecified if ongoing), notes: Stated that she had Covid in December and waited 90 days before the inoculation. There were no concomitant medications. The following information was reported: SOMNOLENCE (non-serious) with onset 22Mar2021, outcome "recovered" (25Mar2021), described as "First dose: sleepy"; HEADACHE (non-serious) with onset 22Mar2021, outcome "recovered" (25Mar2021), described as "Headache"; FATIGUE (non-serious) with onset 2021, outcome "unknown", described as "Tired". Therapeutic measures were taken as a result of somnolence, headache, fatigue with analgesics and plenty of fluids.  Additional Information:first dose was received 90 days after having Covid.Other Products were No.No Patient History.Investigation Assessment was No.Stated thathad Covid in December and waited 90 days before the inoculation. Stated that this was before any doses. Stated that she had first dose and had a headache and was tired. Stated that her internist said that she had too many antibodies and that Covid would eventually come back and she should not take the booster shot.Treatment: Stated that she took analgesics went to bed drank plenty of fluids for first dose issues.   No follow-up attempts are possible. No further information is expected
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: I would get cold sores around my nose and mouth from one of the herpes viruses. But ever since I took Pfizer dose in February of this year, I never had any more breakouts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 2021 as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 01), administration date: Feb2021, for COVID-19 immunization; Bnt162b2 (Dose 02), administration date: Feb2021, for COVID-19 immunization.  The following information was reported: THERAPEUTIC RESPONSE UNEXPECTED (non-serious) with onset 2021, outcome "unknown", described as "I would get cold sores around my nose and mouth from one of the herpes viruses. But ever since I took Pfizer dose in February of this year, I never had any more breakouts".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, UNK
Symptoms: Blood glucose, Blood glucose increased
Clinical narrative: blood sugar increased; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from License Party. Other Case identifier(s): 20211002640.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation; semaglutide (OZEMPIC) (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for Covid-19 immunization. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "blood sugar increased". Relevant laboratory tests and procedures are available in the appropriate section. The action taken for semaglutide was unknown. Therapeutic measures were taken as a result of blood glucose increased. Additional information: A patient receiving therapy with Ozempic and Pfizer Covid vaccine reported blood sugar increased after 2nd Covid vaccine and booster, treated with increased dose of Levemir Flex Touch. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Nausea
Clinical narrative: Dizziness; Headache the night and morning after the vaccine; Nausea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 38 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 04Nov2021 10:00 (Lot number: FF8841) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE, Batch/Lot No: EL3248), administration date: 01Feb2021, when the patient was 37 years old, for COVID-19 immunization; Bnt162b2 (DOSE 1, SINGLE, Batch/Lot No: EL3248), administration date: 12Jan2021, when the patient was 37 years old, for COVID-19 immunization. The following information was reported: DIZZINESS (non-serious) with onset 04Nov2021 23:30, outcome "recovering", described as "Dizziness"; HEADACHE (non-serious) with onset 04Nov2021 23:30, outcome "recovering", described as "Headache the night and morning after the vaccine"; NAUSEA (non-serious) with onset 04Nov2021 23:30, outcome "recovering", described as "Nausea". Therapeutic measures were not taken as a result of dizziness, headache, nausea.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications were received by the patient within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The patient did not get covid tested post vaccination. The patient did not have any known allergies.  Follow-up attempts are completed. No further information is expected.