chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Fatigued; Have a lot of pain in their left calf of their leg - very sore to the touch; This is a spontaneous report received from a contactable consumer (patient's husband).  An adult female patient received BNT162B2 (BNT162B2), administered in arm right, administration date 19Mar2021 13:45 (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: FATIGUE (non-serious) with onset 22Mar2021 12:00, outcome "not recovered", described as "Fatigued"; PAIN IN EXTREMITY (non-serious) with onset 22Mar2021 12:00, outcome "not recovered", described as "Have a lot of pain in their left calf of their leg - very sore to the touch". Therapeutic measures were not taken as a result of fatigue, pain in extremity.  Additional Information: The patient and her husband both had the first Pfizer COVID-19 vaccine dose last Friday. They were both very fatigued and have a lot of pain in their left calf of their leg - very sore to the touch. These symptoms started on Monday of this week (22Mar2021).  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2021351681 Same reporter, product, and event; different patient
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue
Clinical narrative: Very Dizzy; Exhausted; 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 female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 18Mar2021 13:15 (Lot number: EN6208) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hypophosphatasia", start date: Apr2018 (unspecified if ongoing), notes: rare genetic disease; was born with this but was diagnosed in the spring; "slipped and fell" (unspecified if ongoing), notes: couple of days before Covid shot, was starting to feel better and was up and about stuff; "I hit my head in the back" (unspecified if ongoing), notes: couple of days before Covid shot, was starting to feel better and was up and about stuff; "mild concussion" (unspecified if ongoing), notes: recuperating; couple of days before Covid shot, was starting to feel better & was up & about stuff; "allergic reaction to the treatment for my rare disease" (unspecified if ongoing). Concomitant medication(s) included: BENADRYL taken for drug hypersensitivity; STRENSIQ taken for hypophosphatasia. The following information was reported: DIZZINESS (non-serious) with onset 19Mar2021 08:30, outcome "not recovered", described as "Very Dizzy"; FATIGUE (non-serious) with onset 19Mar2021 08:30, outcome "not recovered", described as "Exhausted". Therapeutic measures were not taken as a result of dizziness, fatigue. Additional information: When probed if the events were worsened, improved or persisting, consumer stated, "It's worsened I would say, I would have said persisting maybe couple of days ago and it's really honestly getting worst.". Date for the second vaccination was due on "08Apr.".  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: she developed a lump in her lymph node under her right armpit; This is a spontaneous report received from non-contactable reporter(s) (Consumer or other non HCP) from a sales representative. The reporter is the patient.  A 59 year-old female patient received bnt162b2 (BNT162B2), administered in arm right (Lot number: ER8732) as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Covid-19 vaccine (Dose 1, Manufacturer unknown), for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), outcome "unknown", described as "she developed a lump in her lymph node under her right armpit". Clinical course: Within 24 hours after receiving what was her second Pfizer Covid-19 shot, she developed a lump in her lymph node under her right armpit. This was also the same arm that she was injected. The patient did not experience this with her first COVID-19 shot. She was on no concomitant medications and has no underlying conditions.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Body temperature, Body temperature increased
Clinical narrative: Have a slight rise in temperature; 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), administered in arm left, administration date 25Mar2021 08:00 (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 (1st dose), administration date: 04Mar2021, for covid-19 immunisation. The following information was reported: BODY TEMPERATURE INCREASED (non-serious) with onset 25Mar2021 11:15, outcome "unknown", described as "Have a slight rise in temperature". The patient underwent the following laboratory tests and procedures: body temperature: (25Mar2021) slight rise, notes: at 11:15.  Additional information: Patient felt fine and was not dizzy or anything else, just the rise in temperature.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arms swelled up more; Little sore arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received BNT162B2 (BNT162B2), administered in arm right, administration date 20Mar2021 (Lot number: EN6202) as dose 2, single for COVID-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162B2 (dose 1, single; site: right arm), administration date: 27Feb2021, for COVID-19 immunization. The following information was reported: PERIPHERAL SWELLING (non-serious) with onset 2021, outcome " unknown", described as "Arms swelled up more"; PAIN IN EXTREMITY (non-serious) with onset 2021, outcome "unknown", described as "Little sore arm". Therapeutic measures were taken as a result of peripheral swelling, pain in extremity.  Additional information: The patient reported she and her husband both received the second dose on 20Mar2021. They got the first one on 27Feb2021 which they very little to no reaction. The patient's husband had nothing. The patient had a little sore arm, she put ice on it and that was the end of it. But the second time, not that it was anything dramatic that she needed medical care, but her arms swelled up more and it was the first time. She put ice on it. It did not bother her at all. She was able to lift her arm and stuff like that. She received both doses in her right arm. The patient mentioned that when they had the first dose it was a little lower/down to the arm. The second shot was higher up. She doesn't know if that made a difference on that.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: sickness; 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 female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "sickness". Additional information: Patient experienced sickness symptoms and she is asking if she can still get the second dose.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Pain
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient), for a Pfizer sponsored program (005570). A 70-year-old patient received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Feb 7, 2021; and received the 2nd dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Feb 27, 2021, single dose, for COVID-19 immunisation. Medical history included allergic to cats (unspecified if ongoing). The patient took concomitant medications. The patient reported pain (local soreness for a couple of days), with outcome of recovered. Additional information: There was no problem except local soreness for a couple of days. The patient regularly takes steroid inhalant for reactive airway disease. The patient would like to know whether taking steroid inhalant (before and after administration of vaccine)/if this steroid (in particular) changes antibody generation or other response to COVID-19. No follow-up attempts  possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A patient (no qualifiers provided) received the 1st dose of BNT162B2 (Comirnaty, batch/lot# unknown), on Mar 23, 2021, single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient developed illness/became really sick (non-serious), with outcome of unknown. Additional information: Patient had the Pfizer vaccine the COVID-19 vaccine on Tuesday. It was the patient's first dose, and has been really sick since Wednesday. The patient believed people didn't really get much of a reaction after the first dose; but people really got sick with the second dose. Patient was concerned and didn't know if this was normal. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: blurred vision; This is a spontaneous report received from a contactable reporter (Physician) for a Pfizer sponsored program (159558).  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE) (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: VISION BLURRED (non-serious), outcome "unknown", described as "blurred vision".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: Fatigue; This is a spontaneous report received from a contactable reporter (Nurse). A 75-year-old male patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date Feb2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious) with onset 28Feb2021, outcome "recovered", described as "Fatigue". Therapeutic measures were not taken as a result of fatigue.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient) for a Pfizer sponsored program (159558). A male patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), on Jan 29, 2021; and received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, solution for injection, batch/lot# unknown), on Feb 26, 2021; both single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient had lymphadenopathy/swollen lymph nodes, with outcome of unknown. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Condition aggravated
Clinical narrative: Monitor blood sugar, it gave me reading of 166, checked it again and it said 196, checked it back to back it said 202 and third time it said 187; Monitor blood sugar, it gave me reading of 166, checked it again and it said 196, checked it back to back it said 202 and third time it said 187; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received BNT162B2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE, solution for injection), administration date 27Mar2021 09:00 (Batch/Lot number: unknown) as dose 2, single for COVID-19 immunisation. Relevant medical history included: "diabetic" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (First Dose), for Covid-19 immunisation. The following information was reported: BLOOD GLUCOSE INCREASED (non-serious), CONDITION AGGRAVATED (non-serious) all with onset 28Mar2021, outcome "unknown" and all described as "Monitor blood sugar, it gave me reading of 166, checked it again and it said 196, checked it back to back it said 202 and third time it said 187". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information:  The only one thing that the patient did noticed, was, the patient was diabetic but do not take any medication for this, mostly keep it under control with diet. Monitor blood sugar every morning, it was 107 which is okay for me. And then when the patient ate some food at 3-o-clock, normally do not check it twice a day but have eaten something not nothing sweet but a lot of chips. So at 3-o-clock the patient just ate that food. So, like 7, the patient decided to check it again because the patient was getting hungry, reading of 166 which was okay, that did not concern so much, it is just 4 hours and it will most probably come down soon to in a way to 108 to 90. But this is what the patient did not understand after that 166 the patient waited another hours and checked it again and it said 196, so that kind of warned the patient, not experience that but it was for the patient, there was a time at evening that the patient checked it back to back and the second time, it said 202. And checked it third time, checked machine to make sure the reading was right and the third time it said 187 and the patient was like I had not eaten anything for like 5 hours when I checked at 8-o-clock. So now have you had any report of this vaccine raising people the blood sugar level?"  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Breast discolouration, Feeling abnormal, Mammogram, Ultrasound testes
Clinical narrative: discoloration on her breast; immediately felt the vaccine in their arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2), administered in arm (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: BREAST DISCOLOURATION (non-serious), outcome "not recovered", described as "discoloration on her breast"; FEELING ABNORMAL (non-serious), outcome "unknown", described as "immediately felt the vaccine in their arm". The event "discoloration on her breast" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section.  Additional Information : The patient (Age: 74, Unit: Unknown) reported that, after the first dose that patient received on a Friday, that Monday when patient was getting dressed, noticed discoloration on her breast and it was on opposite side on where patient got the injection. Patient saw a gynecologist in which they did a mammogram and an ultrasound, but did not see any lumps. The patient reported that the gynecologist did not think it was anything, but the "discoloration is still there, had not changed, other than faded some. The patient reported that her and her husband (74-year-old, male) immediately felt the vaccine in their arm with the first dose, but felt nothing with the second injection.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Vertigo
Clinical narrative: Vertigo; I start to get a little dizzy on the right side of my ear specially when I lay down; This is a spontaneous report received from a contactable reporter (consumer). The reporter is the patient.  A 72 year-old female patient received BNT162b2 (PFIZER-BIONTECH COVID-19 VACCINE) administration date 09Feb2021 (Batch/Lot number: unknown) at the age of 72 years as dose 1, single and administration date 02Mar2021 (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: VERTIGO (non-serious) with onset Feb2021, outcome "unknown", described as "Vertigo"; DIZZINESS (non-serious) with onset Feb2021, outcome "unknown", described as "I start to get a little dizzy on the right side of my ear specially when I lay down".  Additional information: The patient noticed that after she got the first one, may be a week later she thought it was vertigo. She said that "the first one, may be after 2 weeks I start to get a little dizzy on the right side of my ear specially when I lay down and it's like vertigo because I had this before in the year of the beginning in January. About 2 weeks after February, I started feeling of little dizziness when I was lying down." The patient added that when she took the second vaccine in March, she still has it when she lay down on the bed when turning on right side and it lasted about 5 seconds.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Mass, Muscle spasms, Nasopharyngitis
Clinical narrative: Shaking; terribly cold; very bad Chills; I have extreme fatigue which I still kind of have right now; have been sleeping like all day and night like all week, I didn't go down from bed, I am just really tired; I have my cheeks were very pink, pink like rash on the cheeks it's down half way down my arm; so I have a knot in my arm; Cramp; 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 70 year-old female patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Lot number: EV8723) as dose 2, single and administration date 18Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Respiratory failure" (unspecified if ongoing), notes: Verbatim: Respiratory failure, Yes I am on oxygen 24 hours a day from last 3 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: EN6205, expiration: Jun21, after the 1st vaccination I had less fatigue), administration date: 25Feb2021, when the patient was 70 years old, for COVID-19 immunization, reaction(s): "after the 1st vaccination I had less fatigue". The following information was reported: TREMOR (non-serious) with onset 2021, outcome "unknown", described as "Shaking"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "terribly cold"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "very bad Chills"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "I have extreme fatigue which I still kind of have right now"; SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "have been sleeping like all day and night like all week, I didn't go down from bed, I am just really tired"; RASH (non-serious) with onset 2021, outcome "unknown", described as "I have my cheeks were very pink, pink like rash on the cheeks it's down half way down my arm"; MASS (non-serious) with onset 2021, outcome "unknown", described as "so I have a knot in my arm"; MUSCLE SPASMS (non-serious) with onset 2021, outcome "unknown", described as "Cramp". Therapeutic measures were not taken as a result of tremor, nasopharyngitis, chills, fatigue, somnolence, rash, mass.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Somnolence, Tremor
Clinical narrative: Shaking; terribly cold; very bad Chills; I have extreme fatigue which I still kind of have right now; have been sleeping like all day and night like all week, I didn't go down from bed, I am just really tired; I have my cheeks were very pink, pink like rash on the cheeks it's down half way down my arm; so I have a knot in my arm; Cramp; 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 70 year-old female patient received bnt162b2 (BNT162B2), administration date 25Mar2021 (Lot number: EV8723) as dose 2, single and administration date 18Oct2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Respiratory failure" (unspecified if ongoing), notes: Verbatim: Respiratory failure, Yes I am on oxygen 24 hours a day from last 3 years. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Lot: EN6205, expiration: Jun21, after the 1st vaccination I had less fatigue), administration date: 25Feb2021, when the patient was 70 years old, for COVID-19 immunization, reaction(s): "after the 1st vaccination I had less fatigue". The following information was reported: TREMOR (non-serious) with onset 2021, outcome "unknown", described as "Shaking"; NASOPHARYNGITIS (non-serious) with onset 2021, outcome "unknown", described as "terribly cold"; CHILLS (non-serious) with onset 2021, outcome "unknown", described as "very bad Chills"; FATIGUE (non-serious) with onset 2021, outcome "not recovered", described as "I have extreme fatigue which I still kind of have right now"; SOMNOLENCE (non-serious) with onset 2021, outcome "unknown", described as "have been sleeping like all day and night like all week, I didn't go down from bed, I am just really tired"; RASH (non-serious) with onset 2021, outcome "unknown", described as "I have my cheeks were very pink, pink like rash on the cheeks it's down half way down my arm"; MASS (non-serious) with onset 2021, outcome "unknown", described as "so I have a knot in my arm"; MUSCLE SPASMS (non-serious) with onset 2021, outcome "unknown", described as "Cramp". Therapeutic measures were not taken as a result of tremor, nasopharyngitis, chills, fatigue, somnolence, rash, mass.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: I am not feeling well at all, this is hard for me even to reach out for help right now; I don''t feel well, I don''t feel good; 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 (COMIRNATY), administration date 06Jan2022 (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: Covid-19 vaccine (Manufacturer: Unknown, Dose number: 1), for Covid-19 immunization. The following information was reported: MALAISE (non-serious) with onset 06Jan2022, outcome "unknown", described as "I am not feeling well at all, this is hard for me even to reach out for help right now; I don''t feel well, I don''t feel good".  Additional information: Consumer stated, "I am trying to figure out if I need to go to the ER, I got my second COVID shot today its a Pfizer shot, I am not feeling well at all and I never get sick. So this is hard for me even to reach out for help right now." Consumer was suggested to contact the nearest Pharmacy or Clinic in case of emergency.   No follow-up attempts are completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Tinnitus
Clinical narrative: Had strong ringing in my ears; Very tired; This is a spontaneous report received from a contactable reporter(s) (other healthcare professional). The reporter is the patient. A 62-year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 06Jan2022 08:15 (Lot number: 33025BD) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Being treated from a bad fall which had several surgeries as a result from falls." (Unspecified if ongoing), "Being treated from a bad fall which had several surgeries as a result from falls." (Unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN, CARISOPRODOL, HYDROCODONE/IBUPROFEN, ATORVASTATIN, TRAZODONE, DICLOFENAC SODIUM. Vaccination history included: Bnt162b2 (Dose number: 1, Lot number: EH9899, Route: Intramuscular, Vaccine location: Right arm) administration date: 29Dec2020 for COVID-19 immunisation, Bnt162b2 (Dose number: 2, Lot number: EL1284, Route: Intramuscular, Vaccine location: Right arm) administration date: 19Jan2021 for COVID-19 immunisation. The following information was reported: TINNITUS (non-serious) with onset 06Jan2022 12:30, outcome "recovering", described as "Had strong ringing in my ears", FATIGUE (non-serious) with onset 06Jan2022 12:30, outcome "recovering", described as "Very tired". Therapeutic measures were not taken as a result of tinnitus, fatigue.  Additional information: Prior to vaccination, was the patient did not diagnosed with COVID-19. Since the vaccination, patient has been tested for COVID-19 was unknown. Patient not had known allergies. Patient adverse event started with in four and half hours after the third dose patient became very tired, had strong ringing in my ears. Had to go home from work.  Follow-Up (18Jan2022): Follow-up attempts are completed. No further information is expected.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Vomiting
Clinical narrative: vomiting; Headache; dizziness; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 47 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 16Dec2021 12:30 (Lot number: 33130BA) at the age of 47 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Migraines" (unspecified if ongoing); "Dysphonia" (unspecified if ongoing); "Vertigo (vestibular disorder)" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Known allergies: dilantin, reaction(s): "Known allergies: Dilantin"; Known allergies: venlafaxine, reaction(s): "Known allergies: Venlafaxine". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: ER8730, Location of injection: Arm Left, Vaccine Administration Time: 02:15 PM), administration date: 30Mar2021, when the patient was 46 years old, for COVID-19 immunization. The following information was reported: VOMITING (non-serious) with onset 17Dec2021 02:30, outcome "unknown", described as "vomiting"; HEADACHE (non-serious) with onset 17Dec2021 02:30, outcome "unknown", described as "Headache"; DIZZINESS (non-serious) with onset 17Dec2021 02:30, outcome "unknown", described as "dizziness". Therapeutic measures were not taken as a result of vomiting, headache, dizziness.  Additional information: Patient was not received other vaccine in four-weeks. The patient did not receive any other medications in two-weeks. Patient was not diagnosed with covid-19 prior to vaccination. The patient not tested COVID post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Condition aggravated, Tinnitus
Clinical narrative: ringing is extreme/tinnitus; I have problems with tinnitus but now it is turned up in volume 10 fold; 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) (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 but unknown manufacturer), for Covid-19 immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Pfizer booster"; TINNITUS (non-serious), outcome "not recovered", described as "ringing is extreme"; TINNITUS (non-serious), outcome "not recovered", described as "tinnitus"; CONDITION AGGRAVATED (non-serious), outcome "not recovered", described as "I have problems with tinnitus but now it is turned up in volume 10 fold". Additional information: Customer Verbatim: I am experiencing very loud tinnitus since my Pfizer booster. I have problems with tinnitus but now it is turned up in volume 10 fold. Are there others that are experiencing this? Please advise on steps to take to fix this as it is making my life miserable. The ringing is extreme.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Interchange of vaccine products, Limb discomfort, Off label use, Pain
Clinical narrative: her first two doses were the Moderna COVID vaccines; her first two doses were the Moderna COVID vaccines; "throbbing, constant pain" in her left arm, specifically "in the shoulder; in the shoulder, like the rotator cuff; Her arm has a throbbing, constant pain; the arm she took it in, and she can't raise it; Her arm has a throbbing, constant pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 24Oct2021 (Lot number: FF2593) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL; ALENDRONATE SODIUM. Vaccination history included: Moderna covid vaccines (Dose no :1, Lot Number: 010M2OA), administration date: 29Jan2021, when the patient was 66 years old, for Covid-19 Immunization, reaction(s): "Fever", "headache", "fatigue", "pain at the injection site"; Moderna covid vaccines (Dose no: 2, Lot Number: 014M2OA), administration date: 28Feb2021, when the patient was 66 years old, for Covid-19 Immunization, reaction(s): "Fever", "headache"; Moderna covid vaccines (Dose no: 2, Lot Number: 014M2OA), for Covid-19 Immunization, reaction(s): "fatigue", "pain at the injection site".  The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "her first two doses were the Moderna COVID vaccines"; ARTHRALGIA (non-serious), outcome "not recovered", described as ""throbbing, constant pain" in her left arm, specifically "in the shoulder"; ROTATOR CUFF SYNDROME (non-serious), outcome "not recovered", described as "in the shoulder, like the rotator cuff"; LIMB DISCOMFORT (non-serious) with onset Oct2021, outcome "not recovered", described as "the arm she took it in, and she can't raise it"; PAIN (non-serious) with onset Oct2021, outcome "not recovered", PAIN IN EXTREMITY (non-serious), outcome "not recovered" and all described as "Her arm has a throbbing, constant pain". Therapeutic measures were taken as a result of arthralgia, rotator cuff syndrome, limb discomfort, pain, pain in extremity.  Additional information: it was reported that patient received Tylenol, bio freeze, artic cream and the hemp oil as a result of treatment for adverse events.  No follow-up attempts are possible. No further information is expected.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Rotator cuff syndrome
Clinical narrative: her first two doses were the Moderna COVID vaccines; her first two doses were the Moderna COVID vaccines; "throbbing, constant pain" in her left arm, specifically "in the shoulder; in the shoulder, like the rotator cuff; Her arm has a throbbing, constant pain; the arm she took it in, and she can't raise it; Her arm has a throbbing, constant pain; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 67 year-old female patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 24Oct2021 (Lot number: FF2593) at the age of 67 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: LISINOPRIL; ALENDRONATE SODIUM. Vaccination history included: Moderna covid vaccines (Dose no :1, Lot Number: 010M2OA), administration date: 29Jan2021, when the patient was 66 years old, for Covid-19 Immunization, reaction(s): "Fever", "headache", "fatigue", "pain at the injection site"; Moderna covid vaccines (Dose no: 2, Lot Number: 014M2OA), administration date: 28Feb2021, when the patient was 66 years old, for Covid-19 Immunization, reaction(s): "Fever", "headache"; Moderna covid vaccines (Dose no: 2, Lot Number: 014M2OA), for Covid-19 Immunization, reaction(s): "fatigue", "pain at the injection site".  The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown" and all described as "her first two doses were the Moderna COVID vaccines"; ARTHRALGIA (non-serious), outcome "not recovered", described as ""throbbing, constant pain" in her left arm, specifically "in the shoulder"; ROTATOR CUFF SYNDROME (non-serious), outcome "not recovered", described as "in the shoulder, like the rotator cuff"; LIMB DISCOMFORT (non-serious) with onset Oct2021, outcome "not recovered", described as "the arm she took it in, and she can't raise it"; PAIN (non-serious) with onset Oct2021, outcome "not recovered", PAIN IN EXTREMITY (non-serious), outcome "not recovered" and all described as "Her arm has a throbbing, constant pain". Therapeutic measures were taken as a result of arthralgia, rotator cuff syndrome, limb discomfort, pain, pain in extremity.  Additional information: it was reported that patient received Tylenol, bio freeze, artic cream and the hemp oil as a result of treatment for adverse events.  No follow-up attempts are possible. No further information is expected.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Dysphonia, Hypoaesthesia, Inappropriate schedule of product administration, Mass
Clinical narrative: nose run; ears are still humming and ringing; numbness in fingers; developed lump on her  pinky finger / a lump on her left foot (toe), lump on right side of her stomach; raspy voice; developed lump on her  pinky finger / a lump on her left foot (toe), lump on right side of her stomach; she felts 'these pains'; diarrhea; Her employer made her get the 2nd shot 45 days later; 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 56 year-old female patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 56 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "fingers and toes numb", "fingers and toes numb", "ringing/humming in ears". The following information was reported: RHINORRHOEA (non-serious), outcome "not recovered", described as "nose run"; TINNITUS (non-serious), outcome "not recovered", described as "ears are still humming and ringing"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "numbness in fingers"; MASS (non-serious), STOMACH MASS (non-serious), outcome "unknown" and all described as "developed lump on her pinky finger / a lump on her left foot (toe), lump on right side of her stomach"; DYSPHONIA (non-serious), outcome "unknown", described as "raspy voice"; PAIN (non-serious), outcome "unknown", described as "she felts 'these pains'"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 27Dec2021, outcome "unknown", described as "Her employer made her get the 2nd shot 45 days later". The events "nose run", "ears are still humming and ringing", "numbness in fingers", "developed lump on her pinky finger / a lump on her left foot (toe), lump on right side of her stomach", "raspy voice", "developed lump on her pinky finger / a lump on her left foot (toe), lump on right side of her stomach", "she felts 'these pains'" and "diarrhea" were evaluated at the physician office visit.  Additional information: The patient received the 2nd shot of Pfizer COVID vaccine on 27Dec2021 and reports that it made her nose run and was ongoing, ears were still humming and ringing, numbness in fingers remains and now she developed lump on her pinky finger, a lump on her left foot (toe), lump on right side of her stomach. Stated she felts 'these pains' and started rubbing it and was a lump. Also reports having had diarrhea and an ongoing raspy voice. Stated she knows it was from the vaccine. Stated she went to her HCP but her HCP doesn't know what to do. Asking for recommendations on how to get rid of humming and ringing noise in ears and the lumps on her body.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rhinorrhoea, Stomach mass, Tinnitus
Clinical narrative: nose run; ears are still humming and ringing; numbness in fingers; developed lump on her  pinky finger / a lump on her left foot (toe), lump on right side of her stomach; raspy voice; developed lump on her  pinky finger / a lump on her left foot (toe), lump on right side of her stomach; she felts 'these pains'; diarrhea; Her employer made her get the 2nd shot 45 days later; 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 56 year-old female patient received bnt162b2 (COMIRNATY), administration date 27Dec2021 (Batch/Lot number: unknown) at the age of 56 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s): "fingers and toes numb", "fingers and toes numb", "ringing/humming in ears". The following information was reported: RHINORRHOEA (non-serious), outcome "not recovered", described as "nose run"; TINNITUS (non-serious), outcome "not recovered", described as "ears are still humming and ringing"; HYPOAESTHESIA (non-serious), outcome "not recovered", described as "numbness in fingers"; MASS (non-serious), STOMACH MASS (non-serious), outcome "unknown" and all described as "developed lump on her pinky finger / a lump on her left foot (toe), lump on right side of her stomach"; DYSPHONIA (non-serious), outcome "unknown", described as "raspy voice"; PAIN (non-serious), outcome "unknown", described as "she felts 'these pains'"; DIARRHOEA (non-serious), outcome "unknown", described as "diarrhea"; INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (non-serious) with onset 27Dec2021, outcome "unknown", described as "Her employer made her get the 2nd shot 45 days later". The events "nose run", "ears are still humming and ringing", "numbness in fingers", "developed lump on her pinky finger / a lump on her left foot (toe), lump on right side of her stomach", "raspy voice", "developed lump on her pinky finger / a lump on her left foot (toe), lump on right side of her stomach", "she felts 'these pains'" and "diarrhea" were evaluated at the physician office visit.  Additional information: The patient received the 2nd shot of Pfizer COVID vaccine on 27Dec2021 and reports that it made her nose run and was ongoing, ears were still humming and ringing, numbness in fingers remains and now she developed lump on her pinky finger, a lump on her left foot (toe), lump on right side of her stomach. Stated she felts 'these pains' and started rubbing it and was a lump. Also reports having had diarrhea and an ongoing raspy voice. Stated she knows it was from the vaccine. Stated she went to her HCP but her HCP doesn't know what to do. Asking for recommendations on how to get rid of humming and ringing noise in ears and the lumps on her body.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Axillary mass, Pain
Clinical narrative: developing a small lump under my left arm that hurts, in the armpit, If I lay on it with my arm up high, it hurts; developing a small lump under my left arm that hurts, in the armpit, If I lay on it with my arm up high, it hurts; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 13Dec2021 (Lot number: 33130BA) as dose 3(booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose:1, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization; Covid-19 vaccine (Dose: 2, Primary Immunization series complete but unknown manufacturer), for COVID-19 Immunization. The following information was reported: AXILLARY MASS (non-serious), PAIN (non-serious), outcome "unknown" and all described as "developing a small lump under my left arm that hurts, in the armpit, If I lay on it with my arm up high, it hurts". No follow-up attempts are needed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, Blood cholesterol increased
Clinical narrative: This is a spontaneous report received from a contactable other-HCP (patient). A female patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), single  dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient reported increased blood cholesterol (her cholesterol has elevated by 80 right after she received product), with outcome of unknown. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: Patient stated she received the vaccine, including booster. Patient stated her cholesterol was elevated by 80 right after she received product. Patient indicated it has been steady for years and since May has elevated. Patient was asking for information on this topic. No follow-up attempts possible. Information about batch/lot number cannot be obtained. No further information expected.
Sex: U
Vaccine: COVID19
Symptoms: Alopecia, Immunisation, Interchange of vaccine products, Off label use
Clinical narrative: was vaccinated against COVID-19 in March2021 with the Johnson & Johnson vaccine; I was vaccinated against COVID-19 in March 2021 with the Johnson & Johnson vaccine; Within 3 weeks the hair on my head started to fall out/I had significant hair loss; received my booster shot , by Pfizer on 20Dec2021; 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 57 year-old patient received bnt162b2 (BNT162B2), administration date 20Dec2021 (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Janssen covid-19 vaccine (I had zero side effects.), administration date: Mar2021, for COVID-19 Immunization, reaction(s): "No adverse effect". The following information was reported: IMMUNISATION (non-serious) with onset 20Dec2021, outcome "unknown", described as "received my booster shot , by Pfizer on 20Dec2021"; OFF LABEL USE (non-serious), outcome "unknown", described as "was vaccinated against COVID-19 in March2021 with the Johnson & Johnson vaccine"; INTERCHANGE OF VACCINE PRODUCTS (non-serious), outcome "unknown", described as "I was vaccinated against COVID-19 in March 2021 with the Johnson & Johnson vaccine"; ALOPECIA (non-serious), outcome "not recovered", described as "Within 3 weeks the hair on my head started to fall out/I had significant hair loss".  Additional information: Patient was vaccinated against COVID-19 in Mar2021 with the Johnson & Johnson vaccine and had zero side effects. Patient received booster shot , by Pfizer on 20Dec2021. Within 3 weeks the hair on head started to fall out. Upon showering , patient had significant hair loss, and hair loss still continues to this day 09Jan2022. Patient have always had a full & healthy head of hair, whole life, and believes this hair loss is a direct result of the PFIZER booster.  The lot number for bnt162b2 was not provided and will be requested during follow up
Sex: M
Vaccine: COVID19
Symptoms: Energy increased, Therapeutic response unexpected
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP). A male patient received unknown dose number of BNT162B2 (Comirnaty, batch/lot# unknown), single dose, for COVID-19 immunisation. The patient's medical history and concomitant medications not reported. The patient experienced an unexpected therapeutic response: increased energy (her boyfriend felt energy boost after booster dose), with outcome of unknown. The lot number for BNT162B2 not provided and will be requested during follow-up.