chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Computerised tomogram head, Dizziness, Headache, Nausea
Clinical narrative: I have had a persistent right sided headache after receiving the Pfizer Covid-19 vaccine. The pain is constant and never goes away.; It has become debilitating.; This headache is causing me to be dizzy; This headache is causing me to be dizzy and nauseated.; This is a spontaneous report from a non-contactable reporter (consumer or other non HCP). The reporter is the patient.   A 36-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in left arm, administration date 28Feb2022 (Lot number: unknown) at the age of 36 years as dose 1, single for COVID-19 immunisation. Relevant medical history included: "COVID-19" (unspecified if ongoing), notes: Prior to vaccination, was the patient diagnosed with COVID-19?:Yes. The patient did not receive any concomitant medications. Past drug history included: Stadol, reaction: "Drug allergy", notes: Known allergies: Stadol.  The following information was reported: HEADACHE (non-serious) with onset 01Mar2022, outcome "not recovered", described as "I have had a persistent right sided headache after receiving the Pfizer Covid-19 vaccine. The pain is constant and never goes away"; ASTHENIA (non-serious) with onset 01Mar2022, outcome "not recovered", described as "It has become debilitating"; DIZZINESS (non-serious) with onset 01Mar2022, outcome "not recovered", described as "This headache is causing me to be dizzy"; NAUSEA (non-serious) with onset 01Mar2022, outcome "not recovered", described as "This headache is causing me to be dizzy and nauseated". The events "I have had a persistent right sided headache after receiving the Pfizer Covid-19 vaccine. The pain is constant and never goes away.", "It has become debilitating.", "This headache is causing me to be dizzy" and "This headache is causing me to be dizzy and nauseated." were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of headache, asthenia, dizziness and nausea.  Additional information: Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. It was reported that the patient had to see a neurologist to get those headaches managed because OTC Motrin, Tylenol, and Excedrin did not help ease the headaches. She had to have a computerized tomography (CT) scan of head/brain to rule out Cerebral venous thrombosis (CVT) and would be having a Magnetic resonance imaging (MRI). The patient never had headaches like those before the vaccine. The patient would have had an occasional headache from time to time that was resolved with over-the-counter (OTC) medication. She had never been diagnosed with migraines. Treatment included Fioricet and Tizanidine for headache, asthenia, dizziness and nausea. Since the vaccination, the patient had not been tested for COVID-19.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infection; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 85 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2020 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Shingles vaccine (Shingles vaccine several years ago.), for immunization; Bnt162b2 (DOSE 1, SINGLE), administration date: Apr2020, for COVID-19 Immunization. The following information was reported: SINUSITIS (non-serious), outcome "recovering", described as "sinus infection". They gave her steroids and antibiotics for the Sinus Infection. Therapeutic measures were taken as a result of sinusitis. The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 18.0
Sex: M
Vaccine: COVID19
Symptoms: Otitis media
Clinical narrative: Middle Ear Infection; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 19-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 28Mar2022 13:15 (Batch/Lot number: unknown) at the age of 18 years as dose 3 (booster), single for covid-19 immunization. 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: Unknown. Unable to locate or read the details), administration date: 10Sep2021, when the patient was 18 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right), administration date: Oct2021, when the patient was 18 years old, for Covid-19 Immunization. The following information was reported: OTITIS MEDIA (non-serious) with onset 30Mar2022, outcome "unknown", described as "Middle Ear Infection". The event "middle ear infection" was evaluated at the physician office visit. Therapeutic measures were taken as a result of otitis media.  Additional information: Patient used facility where the most recent COVID-19 vaccine was administered as Pharmacy or Drug Store. The patient did not receive any other vaccines within 4 weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Reported Event: Middle Ear Infection 2 days after 3rd shot. The events did not result in doctor or other healthcare professional office/clinic visit. Treatment received for the adverse events was antibiotics. Prior to the vaccination, the patient was unknown diagnosed with COVID-19. Since the vaccination, the patient had unknown been tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: starting to get a sore throat; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 03Apr2022 (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 immunization series complete, unknown manufacturer), for Covid-19 Immunization.  The following information was reported: OROPHARYNGEAL PAIN (non-serious) with onset 03Apr2022, outcome "unknown", described as "starting to get a sore throat".  Additional information: Patient just had booster with the Pfizer vaccine (Further clarified as Pfizer COVID-19 vaccine) and patent was starting to get a sore throat. Patient was wondering could take any Ibuprofen."  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 40 year-old patient received bnt162b2 (BNT162B2) (Lot number: FK9894) at the age of 40 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: CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as  "lot of itching under my skin; I got some itching before the COVID shot very worse, it is reduce some since the COVID shot but it's still pretty bad."  Additional information: Consumer stated, I have been learning about, for artificial intelligence since been years for a long time and I'm lot of itching under my skin itself, quite a while I reported it with the last questionnaire (Further clarifications unknown) I have got from you guys but I just also got a COVID shot 'from one' and trying to help with the itching over time (Further clarifications unknown). On paraphrasing: Consumer stated, "I don't have lot of yes, I have had itching before it though too from other things (Further not clarified hence captured as unspecified product) from Pfizer (Hence manufacturer checked). I had, my dad died a few years ago (Further clarifications unknown) and I was, When was it, when was it '2000' that's the case I have, the claim I have right now but I claimed with Pfizer that's what I 'kind of like send you is to' talk somebody with artificial intelligence divisions by the way from Pfizer, so that's kind of who I was trying to talk with but alright (Further clarifications unknown)." When probed to clarify if consumer has any questions regarding it or consumer wants to report it: Consumer stated, "Yes I want to report the issue, yes I got some itching before the COVID shot very worse, it is reduce some since the COVID shot but it's still pretty bad, 'since reported' and I finally got my first one."  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dark circles under eyes
Clinical narrative: Dark circles under eyes that developed after receiving the vaccine; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An adult female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right (Lot number: EW0165) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Known allergies: Narcotics" (unspecified if ongoing). Concomitant medication(s) included: MINOCYCLINE; VITAMIN D3; ATORVASTATIN. Vaccination history included: Bnt162b2 (previous dose product: COVID 19, brand: Pfizer, lot number: EW0182, dose administration time: 02:00 PM, dose number: 2, dose vaccine location: Right arm), administration date: 02Jun2021, for Covid-19 immunization; Bnt162b2 (previous dose product: COVID 19, brand: Pfizer Covid Vaccine, lot number: EW0165, dose administration time: 12:15 PM, dose number: 1, dose vaccine location: Right arm), administration date: 05May2021, for Covid-19 immunization.  The following information was reported: DARK CIRCLES UNDER EYES (non-serious) with onset 07Jan2022, outcome "not recovered", described as "Dark circles under eyes that developed after receiving the vaccine". The event "dark circles under eyes that developed after receiving the vaccine" was evaluated at the physician office visit. Therapeutic measures were not taken as a result of dark circles under eyes.  Additional information: Patient had no other history. Patient did not receive any other vaccine in four weeks. Patient was not tested COVID positive prior and post vaccination. Event was assessed as non-serious.  Follow-up attempts are completed. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: Chills; fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional).   A 58 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 22Mar2022 21:00 (Lot number: FM0698) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 1, single, Administration time: 14:00, Anatomical site of injection: Right shoulder, Route of administration: Intramuscular, Batch/Lot number: EP6955), administration date: 30Mar2021, when the patient was 58 years old, for COVID-19 Immunization, reaction(s): "Mild nausea and body ache", "Mild nausea and body ache", "Chills", "Malaise"; Bnt162b2 (Dose: 2, single, Administration time: 14:00, Anatomical site of injection: Right shoulder, Route of administration: Intramuscular, Batch/Lot number: EP6955), administration date: 20Apr2021, when the patient was 58 years old, for COVID-19 Immunization, reaction(s): "Mild nausea and body ache", "Mild nausea and body ache", "Malaise", "Chills".  The following information was reported: CHILLS (non-serious) with onset 22Mar2022, outcome "recovered" (Mar2022), described as "Chills"; FATIGUE (non-serious) with onset 22Mar2022, outcome "recovered" (Mar2022), described as "fatigue". Therapeutic measures were not taken as a result of chills, fatigue.   Additional information: Patient age at time of vaccination: 58 years. Anatomical site of injection for dose 3: Right shoulder. Dose 3 Batch/Lot number: unable to Locate or Read the Details and Expiration: not available. Complete only if a 3rd dose was administered. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and at risk of serious covid-19 complication). Weakened immune system, If the reason is a weakened immune system, please select one of the conditions below, Current or recent cancer (including blood cancers such as Hodgkin's disease, leukemias, and myelomas), Advanced or untreated HIV infection, Use Of medications that suppress the immune System (e.g., high dose of corticosteroids, cyclosporine, methotrexate, azathioprine, and biologic therapies like rituximab and etanercept), No non-functioning, spleen or kidney failure, Other was not reported. Prior vaccinations (Within 4 weeks) and Relevant tests were none. Specific relevant test for thromboembolic events with thrombocytopenia was none.   No follow-up attempts are possible. No further information is expected.
Age: 17.0
Sex: U
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: Chills; Malaise; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 17 year-old patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 22Mar2022 19:00 (Lot number: FMO698) at the age of 17 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (dose 1, single, Time: 14:00, Anatomical location: Right shoulder, Route of administration: Intramuscular, Batch/Lot number: EP6955), administration date: 30Mar2021, for COVID-19 Immunization; Bnt162b2 (dose 2, single, Time: 14:00, Anatomical location: Right shoulder, Route of administration: Intramuscular, Batch/Lot number: EP6955), administration date: 20Apr2021, for COVID-19 Immunization.  The following information was reported: CHILLS (non-serious) with onset 23Mar2022, outcome "recovered" (2022), described as "Chills"; MALAISE (non-serious) with onset 23Mar2022, outcome "recovered" (2022), described as "Malaise". Therapeutic measures were not taken as a result of chills, malaise.  Additional information: Complete only if a 3rd dose was administered, Check one option. Booster dose due to high risk of frequent institutional or occupational exposure to coronavirus (and a risk of serious cases COVID-19 complications). Vaccination facility type Pharmacy or Drug store. Vaccine administered at military facility No. Prior vaccination None. Specific relevant test for thromboembolic events with thrombocytopenia None.   No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Nausea, Vomiting
Clinical narrative: severe chills; nauseousness; Vomiting; diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2), administration date 03Apr2022 (Batch/Lot number: unknown) as dose 4 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 immunisation, reaction(s): "No adverse reaction"; Bnt162b2 (Dose 2, Batch/Lot number: unknown), for Covid-19 immunisation, reaction(s): "chills", "feelings of nauseousness"; Bnt162b2 (Dose 3 (Booster), Batch/Lot number: unknown), for Covid-19 immunisation, reaction(s): "chills", "feelings of nauseousness". The following information was reported: CHILLS (non-serious) with onset Apr2022, outcome "recovering", described as "severe chills"; NAUSEA (non-serious) with onset Apr2022, outcome "recovering", described as "nauseousness"; VOMITING (non-serious) with onset Apr2022, outcome "recovering", described as "Vomiting"; DIARRHOEA (non-serious) with onset Apr2022, outcome "recovering", described as "diarrhea".  Additional information: The patient had 4th Pfizer shot yesterday. Shot #1 had no reaction. Shots #2 & #3, started 8-hours post-shot and included chills and feelings of nauseousness. Reaction after 4th shot was more severe: severe chills started after 8-hours, nauseousness including vomiting, diarrhea, etc. No fever. This lasted about 6-hours then began to subside. The patient was a little pooped today due to lack of rest, but all will be O.K. The patient was just trying to figure out what occurred.  The lot number of the vaccine [BNT162B2], was not provided and will be requested during follow-up.; Sender's Comments: Linked Report(s) : US-PFIZER_INC-202200516759 Same Reporter, Different Vaccine Dose
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chest pain, Pain in extremity, Peripheral swelling, Vaccination site pain
Clinical narrative: pain at injection site; extreme swelling and pain in left armpit, side of chest and down arm; Pain in left armpit, side of chest and down arm; Pain in left armpit, side of chest and down arm; Pain in left armpit, side of chest and down arm; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 34 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 01Apr2022 17:45 (Lot number: fj9946) at the age of 34 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Known allergies: Penicillin" (unspecified if ongoing); "If COVID prior vaccination: Yes" (unspecified if ongoing). Concomitant medication(s) included: IBUPROFEN. The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 01Apr2022 18:00, outcome "not recovered", described as "pain at injection site"; PERIPHERAL SWELLING (non-serious) with onset 01Apr2022 18:00, outcome "not recovered", described as "extreme swelling and pain in left armpit, side of chest and down arm"; AXILLARY PAIN (non-serious), PAIN IN EXTREMITY (non-serious), CHEST PAIN (non-serious) all with onset 01Apr2022 18:00, outcome "not recovered" and all described as "Pain in left armpit, side of chest and down arm". Therapeutic measures were not taken as a result of vaccination site pain, peripheral swelling, axillary pain, pain in extremity, chest pain.  Additional information: The patient did not received other vaccine in four weeks. Patient was not tested for Covid post vaccination.If COVID tested post vaccination: No.Facility type vaccine Pharmacy or Drug Store. If other vaccine in four weeks: No  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: swelling in her armpit; experiencing some pain in her left wrist; 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 63 year-old female patient received bnt162b2 (BNT162B2), administration date 02Apr2022 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid 19" (unspecified if ongoing), notes: She also mentioned that she has had Covid 19 two times. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization; Covid-19 vaccine (Dose 2, Primary Immunization series complete but unknown manufacturer), for Covid-19 immunization. The following information was reported: ARTHRALGIA (non-serious) with onset 03Apr2022, outcome "unknown", described as "experiencing some pain in her left wrist"; LYMPHADENOPATHY (non-serious) with onset 04Apr2022, outcome "unknown", described as "swelling in her armpit". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Serious: No. Caller received the booster shot of the Pfizer-BioNTech Covid 19 Vaccine on 02Apr2022 and yesterday she was experiencing some pain in her left wrist. She also started experiencing today some swelling in her armpit. She wants to know if these are common side effects due to the vaccine. She also mentioned that she has had Covid 19 two times.   The lot number for [BNT162B2], was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Mass, Pruritus, Rash
Clinical narrative: severe itching within 48 hours after receiving her second dose; with a little lumping; some has really bad skin rash reaction; Caller states the itching interferes with her sleep.; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from medical information team. The reporter is the patient.  A 71 year-old female patient received bnt162b2 (COMIRNATY), administration date 23Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (First dose), administration date: 02Aug2021, for COVID-19 Immunization. The following information was reported: PRURITUS (non-serious) with onset Aug2021, outcome "not recovered", described as "severe itching within 48 hours after receiving her second dose"; MASS (non-serious) with onset Aug2021, outcome "not recovered", described as "with a little lumping"; RASH (non-serious) with onset Aug2021, outcome "not recovered", described as "some has really bad skin rash reaction"; INSOMNIA (non-serious) with onset Aug2021, outcome "not recovered", described as "Caller states the itching interferes with her sleep.". The events "severe itching within 48 hours after receiving her second dose", "with a little lumping", "some has really bad skin rash reaction" and "caller states the itching interferes with her sleep." were evaluated at the physician office visit. Therapeutic measures were taken as a result of pruritus, mass, rash.  Additional information:Caller was a retired nurse reporting an adverse event for the Pfizer Covid-19 vaccine. Caller stated she received her first dose in 2August2021 and second dose of the Pfizer Covid-19 vaccine in 23August2021. Caller stated she didn't have reactions on the first injection. She experienced severe itching within 48 hours after receiving her second dose. Caller has severe itching that goes on and on with a little lumping. Caller has been prescribed with oral medication and topical cream by her Doctor and Dermatologist in August. She stated that she is still itching intermittently. Mostly at night when it's itching, it's severe. Caller wanted people to know that some has really bad skin rash reaction with the vaccine. Caller has not taken other medication that may have cause the skin rashes aside from the vaccine. Caller states the itching interferes with her sleep.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Ankle fracture, Fall, Gait inability, Muscular weakness
Clinical narrative: broke ankle; fell; Lost most of her hair, not growing back; neurological issues; could not walk; sores in her mouth; her leg gave out; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2021NBI06044.  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: ANKLE FRACTURE (non-serious) with onset 2021, outcome "unknown", described as "broke ankle"; FALL (non-serious) with onset 2021, outcome "recovered" (2021), described as "fell"; ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "Lost most of her hair, not growing back"; NEUROLOGICAL SYMPTOM (non-serious) with onset 2021, outcome "unknown", described as "neurological issues"; GAIT INABILITY (non-serious) with onset 2021, outcome "unknown", described as "could not walk"; STOMATITIS (non-serious) with onset 2021, outcome "unknown", described as "sores in her mouth"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "unknown", described as "her leg gave out".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Neurological symptom, Stomatitis
Clinical narrative: broke ankle; fell; Lost most of her hair, not growing back; neurological issues; could not walk; sores in her mouth; her leg gave out; This is a spontaneous report received from contactable reporter(s) (Other HCP). Other Case identifier(s): 2021NBI06044.  A 60 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient relevant medical history and concomitant medications were not reported. The following information was reported: ANKLE FRACTURE (non-serious) with onset 2021, outcome "unknown", described as "broke ankle"; FALL (non-serious) with onset 2021, outcome "recovered" (2021), described as "fell"; ALOPECIA (non-serious) with onset 2021, outcome "unknown", described as "Lost most of her hair, not growing back"; NEUROLOGICAL SYMPTOM (non-serious) with onset 2021, outcome "unknown", described as "neurological issues"; GAIT INABILITY (non-serious) with onset 2021, outcome "unknown", described as "could not walk"; STOMATITIS (non-serious) with onset 2021, outcome "unknown", described as "sores in her mouth"; MUSCULAR WEAKNESS (non-serious) with onset 2021, outcome "unknown", described as "her leg gave out".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: U
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: monthly headaches started after 3rd shot (1st booster) of COVID vaccine; This is a spontaneous report received from contactable reporter(s) (Other HCP) from a sales representative. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 2, Manufacture: Unknown, Primary Immunization series complete), for Covid-19 Immunization; Covid-19 vaccine (Dose: 1, Manufacture: Unknown, Primary Immunization series complete), for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "monthly headaches started after 3rd shot (1st booster) of COVID vaccine". Therapeutic measures were taken as a result of headache.  Additional Information: Reporter says monthly headaches started after 3rd shot (1st booster) of COVID vaccine.  Headaches somewhat respond to Advil or Tylenol and do seem to coincide with hormonal changes related to her period. Name of Product: 3rd shot COVID Vaccine for adult. 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: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Axillary pain, Back pain, Feeling abnormal, Flank pain, Migraine
Clinical narrative: Severe pain in legs and back; Severe pain in legs and back; extreme night sweats; brain fog; migraines; lower flank pain (kidney area); swollen and painful armpits; swollen and painful armpits; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2022 (Lot number: FK9896) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sulfur medications" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: FF2582, Location of injection: Arm Left), administration date: 22Sep2021, when the patient was 34 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: FE3592, Location of injection: Arm Left), administration date: 05Sep2021, when the patient was 34 years old, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious) all with onset 02Apr2022, outcome "not recovered" and all described as "Severe pain in legs and back"; NIGHT SWEATS (non-serious) with onset 02Apr2022, outcome "not recovered", described as "extreme night sweats"; FEELING ABNORMAL (non-serious) with onset 02Apr2022, outcome "not recovered", described as "brain fog"; MIGRAINE (non-serious) with onset 02Apr2022, outcome "not recovered", described as "migraines"; FLANK PAIN (non-serious) with onset 02Apr2022, outcome "not recovered", described as "lower flank pain (kidney area)"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 02Apr2022, outcome "not recovered" and all described as "swollen and painful armpits". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, back pain, night sweats, feeling abnormal, migraine, flank pain, swelling, axillary pain.  Additional Information: The case was not serious. Seriousness criteria (Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect) was not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Reported Event: Severe pain in legs and back, extreme night sweats, brain fog and migraines, lower flank pain (kidney area), inability to thermo regulate during the day, swollen and painful armpits. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Night sweats, Pain in extremity, SARS-CoV-2 test, Swelling
Clinical narrative: Severe pain in legs and back; Severe pain in legs and back; extreme night sweats; brain fog; migraines; lower flank pain (kidney area); swollen and painful armpits; swollen and painful armpits; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 34 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2022 (Lot number: FK9896) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Sulfur medications" (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: FF2582, Location of injection: Arm Left), administration date: 22Sep2021, when the patient was 34 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: FE3592, Location of injection: Arm Left), administration date: 05Sep2021, when the patient was 34 years old, for Covid-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious), BACK PAIN (non-serious) all with onset 02Apr2022, outcome "not recovered" and all described as "Severe pain in legs and back"; NIGHT SWEATS (non-serious) with onset 02Apr2022, outcome "not recovered", described as "extreme night sweats"; FEELING ABNORMAL (non-serious) with onset 02Apr2022, outcome "not recovered", described as "brain fog"; MIGRAINE (non-serious) with onset 02Apr2022, outcome "not recovered", described as "migraines"; FLANK PAIN (non-serious) with onset 02Apr2022, outcome "not recovered", described as "lower flank pain (kidney area)"; SWELLING (non-serious), AXILLARY PAIN (non-serious) all with onset 02Apr2022, outcome "not recovered" and all described as "swollen and painful armpits". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pain in extremity, back pain, night sweats, feeling abnormal, migraine, flank pain, swelling, axillary pain.  Additional Information: The case was not serious. Seriousness criteria (Results in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating, Congenital anomaly/birth defect) was not reported. Facility where the most recent COVID-19 vaccine was administered was Pharmacy or Drug Store. Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications received within 2 weeks of vaccination. Reported Event: Severe pain in legs and back, extreme night sweats, brain fog and migraines, lower flank pain (kidney area), inability to thermo regulate during the day, swollen and painful armpits. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, has the patient been tested for COVID-19.  Follow-up attempts are completed. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Hyperhidrosis, Palpitations, Pyrexia, Rash
Clinical narrative: High fever; sweats; chills; Heart racing/Palpitations; Rash; hives over the entire upper torso; This is a spontaneous report received from contactable reporter consumer or other non HCP. The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2022 10:45 (Lot number: FK9896) at the age of 54 years as dose 4 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 3, Batch/Lot No: FH8020, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 24Oct2021, when the patient was 54 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8731, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 23Apr2021, when the patient was 53 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 31Mar2021, when the patient was 53 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 02Apr2022 22:00, outcome "not recovered", described as "High fever"; HYPERHIDROSIS (non-serious) with onset 02Apr2022 22:00, outcome "not recovered", described as "sweats"; CHILLS (non-serious) with onset 02Apr2022 22:00, outcome "not recovered", described as "chills"; PALPITATIONS (non-serious) with onset 02Apr2022 22:00, outcome "not recovered", described as "Heart racing/Palpitations"; RASH (non-serious) with onset 02Apr2022 22:00, outcome "not recovered", described as "Rash"; URTICARIA (non-serious) with onset 02Apr2022 22:00, outcome "not recovered", described as "hives over the entire upper torso". The events "high fever", "sweats", "chills", "heart racing/palpitations", "rash" and "hives over the entire upper torso" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pyrexia, hyperhidrosis, chills, palpitations, rash, urticaria.  Additional information:-Patient had no known allergies. patient had no seriousness criteria like death, life threatening, disabling/Incapacitating, and congenital anomaly/birth defect. The patient had no other medications in two weeks. Patient does not had any other vaccine in four weeks. The patient does not had covid prior to vaccination. the patient did not taken covid test post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: High fever; sweats; chills; Heart racing/Palpitations; Rash; hives over the entire upper torso; This is a spontaneous report received from contactable reporter consumer or other non HCP. The reporter is the patient.  A 54 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 02Apr2022 10:45 (Lot number: FK9896) at the age of 54 years as dose 4 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 3, Batch/Lot No: FH8020, Location of injection: Arm Left, Vaccine Administration Time: 01:00 PM), administration date: 24Oct2021, when the patient was 54 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8731, Location of injection: Arm Left, Vaccine Administration Time: 12:00 PM), administration date: 23Apr2021, when the patient was 53 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8730, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 31Mar2021, when the patient was 53 years old, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 02Apr2022 22:00, outcome "not recovered", described as "High fever"; HYPERHIDROSIS (non-serious) with onset 02Apr2022 22:00, outcome "not recovered", described as "sweats"; CHILLS (non-serious) with onset 02Apr2022 22:00, outcome "not recovered", described as "chills"; PALPITATIONS (non-serious) with onset 02Apr2022 22:00, outcome "not recovered", described as "Heart racing/Palpitations"; RASH (non-serious) with onset 02Apr2022 22:00, outcome "not recovered", described as "Rash"; URTICARIA (non-serious) with onset 02Apr2022 22:00, outcome "not recovered", described as "hives over the entire upper torso". The events "high fever", "sweats", "chills", "heart racing/palpitations", "rash" and "hives over the entire upper torso" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pyrexia, hyperhidrosis, chills, palpitations, rash, urticaria.  Additional information:-Patient had no known allergies. patient had no seriousness criteria like death, life threatening, disabling/Incapacitating, and congenital anomaly/birth defect. The patient had no other medications in two weeks. Patient does not had any other vaccine in four weeks. The patient does not had covid prior to vaccination. the patient did not taken covid test post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Arthritis, Pain
Clinical narrative: Pain all over my body; Booster must have triggered arthritis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-healthcare professional) for a Pfizer sponsored program. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "Throat cancer" (unspecified if ongoing), notes: I have throat cancer; "Arthritis" (unspecified if ongoing), notes: Booster must have triggered arthritis. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer), for COVID-19 Immunization. The following information was reported: PAIN (non-serious), outcome "unknown", described as "Pain all over my body"; ARTHRITIS (non-serious), outcome "unknown", described as "Booster must have triggered arthritis". Therapeutic measures were taken as a result of pain, arthritis. Additional information: Forwarded as an Adverse Event by the team on 04Apr2022. Reporter provided verification of contact address on 01Apr2022. After receiving the covid booster, the patient began to experience pain all over the body. The patient's doctor said the booster must have triggered arthritis and prescribed celebrex for the pain. The patient only get 1600.00 dollars per month and the medicine was 111.00 per month. Patient tried to get some help from Pfizer but the patient was required to call after filling out the questions. The patient had throat cancer so the patient could not talk therefore the patient could not called.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Investigation, Pain in extremity
Clinical narrative: sore arm; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 76-year-old female patient received bnt162b2 (BNT162B2), administration date 29Oct2021 (Lot number: FD0809) at the age of 76 years as dose 3 (booster), single, administration date 31Mar2021 (Lot number: EW0150) as dose 2, single and administration date 10Mar2021 (Lot number: EN6208) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: LOSARTAN taken for blood pressure measurement; NORVASC taken for blood pressure measurement. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "unknown", described as "sore arm". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She reports last night but states she hasn't had any problems from her previous doses. Caller states she never had these side effects before except a sore arm that she has had before. Patient details: Caller states she thinks that she has shrunk. Caller states weight is unknown, but she is not big and fat. She states she tells the doctor she does not want to be weighed as she is not fooling with that. She states maybe 170 pounds. Caller states she has shrunk over the years and clarifies many years. Caller states the phone broke up. Caller confirms the call is about the COVID-19 vaccine. She states her vaccination card is in her purse. Caller reports the pharmacy gave her some paperwork yesterday maybe her vaccination information will be there. She states the pharmacy gave her a lot of papers. Caller reports all her COVID-19 vaccinations were Pfizer. Caller reports the date is hard to read due to the writing on her card but confirms the date is 31Mar2021. Caller states the date does not sound right. Caller asks does that sound right. Caller states the vaccination took like 3 seconds in her left arm. Indication: Caller states she saw on TV that if greater than 5 months since her last vaccination and if she is immune compromised, she should get a booster dose of the COVID-19 vaccine. She states she does not know if she is immune compromised, but she is old. She reports her granddaughter comes to her house and her granddaughter is not vaccinated. Caller states all her test results came back fine but she needs her physical this month. She reports that she hasn't had her physical since last year, but all her tests were fine last year. Caller declined to complete supplemental form as she states she has someone calling on the other line. No further details to provide.  Follow-up attempts are completed. No further information is expected.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Drug ineffective, SARS-CoV-2 test, Suspected COVID-19
Clinical narrative: A very faint line appeared but after the time limit (15 mins); A very faint line appeared but after the time limit (15 mins); This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 51 year-old male patient received bnt162b2 (BNT162B2), administration date 17Oct2021 (Lot number: FF8841) at the age of 51 years as dose 3 (booster), single, administration date 10Apr2021 (Lot number: EP6955, Expiration Date: 30Jun2021) as dose 2, single and (Lot number: EP6955, Expiration Date: 30Jun2021) 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: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant) all with onset 03Apr2022, outcome "unknown" and all described as "A very faint line appeared but after the time limit (15 mins)". The reporter was the patient's wife who stated that the patient took a rapid test for Covid on 03Apr2022 after learning his son was positive. A very faint line appeared but after the time limit (15 mins). He took another rapid test this morning and it was negative. He was awaiting results from a PCR. His daughter and his wife also fully vaccinated and boosted with the Pfizer vaccine have tested negative this morning on the rapid test. The patient underwent the following laboratory tests and procedures: sars-cov-2 test: (03Apr2022) positive, notes: A very faint line appeared but after the time limit (15 mins); (04Apr2022) negative.
Sex: F
Vaccine: COVID19, UNK
Symptoms: Uveitis
Clinical narrative: Uveitis; This is a solicited report received from contactable reporter(s) (Consumer or other non HCP) for a sponsored program. The reporter is the patient. Other Case identifier(s): 22K-163-4341965-00 (Agency).  A 43 year-old female patient received bnt162b2 (BNT162B2), intramuscular (Batch/Lot number: unknown) as dose 4 (booster), single, intramuscular, administration date Feb2022 (Batch/Lot number: unknown) as dose 3, single, intramuscular, administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and intramuscular, administration date Mar2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown). The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UVEITIS (medically significant), outcome "not recovered", described as "Uveitis". The action taken for adalimumab was dosage permanently withdrawn. Clinical course: It was unknown if patient was enrolled in a covid-19 Vaccine Trial. Event did not abate after stopping drug.  The reporter's causality for the event of UVEITIS was not provided for suspect drug humira (adalimumab). The reporter's causality for the event of UVEITIS was possible for suspect drug Pfizer Biontech COVID-19 vaccine (tozinameran).  The reporter considered "uveitis" related to bnt162b2.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: As there is limited information in the case provided, the causal association between the event Uveitis and the suspect drug cannot be excluded. The case will be reassessed once new information is available.