chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: COVID19
Symptoms: Condition aggravated, Immunisation, Pain
Clinical narrative: This is a spontaneous report received from a 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 02Dec2021 10:00 (Lot number: FJ8762) at the age of 19 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "struggled like heart pain for most of my life" (unspecified if ongoing), notes: struggled like heart pain for most of my life. Concomitant medication(s) included: LEVOTHYROXINE; CONCERTA; FINASTERIDE. Vaccination history included: Bnt162b2 (Dose 1), administration date: 21Mar2021, when the patient was 18 years old, for COVID-19 Immunization, reaction(s): "little swelling in the arm"; Bnt162b2 (Dose 2), administration date: 05Apr2021, when the patient was 18 years old, for COVID-19 Immunization, reaction(s): "headache", "pain in my chest like left side of my chest", "body started to ache", "arm aching". The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021, outcome "unknown", described as "booster shot"; PAIN (non-serious) with onset 02Dec2021, outcome "unknown", described as "it hurts"; CONDITION AGGRAVATED (non-serious) with onset 02Dec2021, outcome "unknown", described as "it's just like it's definitely worse than when I had my second shot". Therapeutic measures were not taken as a result of pain, condition aggravated. Additional information: Prior vaccination (4 Weeks) were none. Patient stated, It might be worst, I am not saying it definitely is. It just hurts. I am just in pain right now. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthritis, Osteoarthritis, Spinal pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old female patient received bnt162b2 (BNT162B2), administration date Aug2021 (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. Relevant medical history included: "Osteoarthritis" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose: 01), for Covid-19 immunization. The following information was reported: OSTEOARTHRITIS (non-serious) with onset 2021, outcome "unknown", described as "my osteoarthritis has gotten extremely worse and it triggered a severe flare up of symptoms"; ARTHRALGIA (non-serious), SPINAL PAIN (non-serious) all with onset 2021, outcome "unknown" and all described as "I have severe pain in my knees, wrists, cervical spine and ankles"; ARTHRITIS (non-serious) with onset 2021, outcome "unknown", described as "severe flare up". Therapeutic measures were taken as a result of osteoarthritis, arthralgia, spinal pain, arthritis. Additional Information: She wanted to make aware that after her second dose in August 2021, her osteoarthritis has gotten extremely worse and it triggered a severe flare up of symptoms. She has had severe pain in her knees, wrists, cervical spine and ankles. Does not know if anyone who currently suffers from osteoporosis has reported having experienced these issues. Was being treated by a Rheumatologist, Orthopedic and pain management. She wanted to bring this to light to inform patients who have osteoarthritis her need to consider these side effects as they are life altering and debilitating. Can be reached should anyone have any questions.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Immunisation, Malaise, Myalgia, Pain in extremity
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).   A 59 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 10:00 (Lot number: FH8027) at the age of 59 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included VITAMIN D3; VITAMIN C; ATORVASTATIN. Vaccination history included Bnt162b2 (Dose Number: 2, Batch/Lot No: Pfizer EL3247, Location of injection: Arm Right, Vaccine Administration Time: 10:30 AM), administration date: 23Feb2021, when the patient was 58 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Pfizer EL3247, Location of injection: Arm Right, Vaccine Administration Time: 10:30 AM), administration date: 02Feb2021, when the patient was 58 years old, for COVID-19 immunisation.  The following information was reported IMMUNISATION (non-serious) with onset 03Dec2021 10:00, outcome unknown; PAIN IN EXTREMITY (non-serious) with onset 03Dec2021 20:00, outcome recovering; MYALGIA (non-serious) with onset 03Dec2021 20:00, outcome recovering; HEADACHE (non-serious) with onset 03Dec2021 20:00, outcome recovering; MALAISE (non-serious) with onset 03Dec2021 20:00, outcome recovering. Therapeutic measures were not taken as a result of pain in extremity, myalgia, headache, and malaise.  No other vaccine in four weeks. No covid prior vaccination. No covid tested post vaccination.  Follow-up attempts are completed. No follow-up attempts are possible. No further information is expected.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lymphadenopathy
Clinical narrative: Swollen Lymph Node; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 52 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 01Dec2021 14:45 (Lot number: FD0809) at the age of 52 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 24Mar2021, when the patient was 51 years old, for COVID-19 immunisation; Bnt162b2 (Dose Number: 1, Batch/Lot No: El3248, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 04Mar2021, when the patient was 51 years old, for COVID-19 immunisation. The following information was reported: IMMUNISATION (non-serious) with onset 01Dec2021 14:45, outcome "unknown", described as "booster"; LYMPHADENOPATHY (non-serious) with onset 02Dec2021, outcome "recovering", described as "Swollen Lymph Node". Therapeutic measures were not taken as a result of lymphadenopathy.  Additional information: The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any other medications within 2 weeks of vaccination. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Immunisation, Influenza like illness, Nausea, Pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 61 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Dec2021 10:45 (Lot number: FG3527) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER2613, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 17Mar2021, when the patient was 61 years old, for COVID-19 Immunisation; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0150, Location of injection: Arm Left, Vaccine Administration Time: 08:00 AM), administration date: 07Apr2021, when the patient was 61 years old, for COVID-19 Immunisation, reaction(s): "Rash on left Arm around shot". The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 10:45, outcome "unknown", described as "Dose Number=03"; NAUSEA (non-serious) with onset 02Dec2021 12:45, outcome "recovered" (03Dec2021 18:00), described as "Nausea"; INFLUENZA LIKE ILLNESS (non-serious) with onset 03Dec2021 02:30, outcome "recovered" (03Dec2021 18:00), described as "flu like"; PAIN (non-serious) with onset 03Dec2021 02:30, outcome "recovered" (03Dec2021 18:00), described as "body aches"; HEADACHE (non-serious) with onset 03Dec2021 02:30, outcome "recovered" (03Dec2021 18:00), described as "headache". Therapeutic measures were not taken as a result of nausea, influenza like illness, pain, headache. Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. No other medications the patient received within 2 weeks of vaccination. Hospitalization Prolonged: No known allergies. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. The device Date was 06Dec2021. No follow-up attempts are possible. No further information is expected.
Age: 18.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Immunisation, Lymphadenopathy, Night sweats, Off label use, Product use issue
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 15:30 (Lot number: FJ5787) at the age of 18 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm right, administration date 03Dec2021 (Batch/Lot number: unknown) as single for immunisation. Relevant medical history included: "Pneumonia", start date: 2015 (unspecified if ongoing), notes: hospitalized for pneumonia in 2015; "Asthma" (unspecified if ongoing), notes: Mild asthma. There were no concomitant medications. Past drug history included: Rocephin, reaction(s): "Drug allergy", notes: known allergies: Rocephin. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0182; Anatomical site: right arm; Route of administration: Unspecified), administration date: 10May2021, when the patient was 17 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE; Lot number: EN9581; Anatomical site: unspecified; Route of administration: Unspecified), administration date: 18Apr2021, when the patient was 17 years old, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 03Dec2021 15:30, outcome "unknown" and all described as "Flu shot received on 03Dec2021 and also received BNT162B2 on 03Dec2021"; IMMUNISATION (non-serious) with onset 03Dec2021 15:30, outcome "unknown", described as "Dose received: 3"; LYMPHADENOPATHY (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Swollen lymph nodes in neck and armpit"; URTICARIA (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Itchy hives on forehead, neck, legs"; NIGHT SWEATS (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Night sweats". Therapeutic measures were taken as a result of lymphadenopathy, urticaria, night sweats. Additional information: The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included unspecified oral Antihistamine, Ibuprofen and topical Cortisol. The patient also received FLU SHOT, administered in right arm, administration date: 03Dec2021 for immunization.
Age: 18.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Urticaria
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 18 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 03Dec2021 15:30 (Lot number: FJ5787) at the age of 18 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administered in arm right, administration date 03Dec2021 (Batch/Lot number: unknown) as single for immunisation. Relevant medical history included: "Pneumonia", start date: 2015 (unspecified if ongoing), notes: hospitalized for pneumonia in 2015; "Asthma" (unspecified if ongoing), notes: Mild asthma. There were no concomitant medications. Past drug history included: Rocephin, reaction(s): "Drug allergy", notes: known allergies: Rocephin. Vaccination history included: Bnt162b2 (DOSE 2, SINGLE; Lot number: EW0182; Anatomical site: right arm; Route of administration: Unspecified), administration date: 10May2021, when the patient was 17 years old, for COVID-19 immunisation; Bnt162b2 (DOSE 1, SINGLE; Lot number: EN9581; Anatomical site: unspecified; Route of administration: Unspecified), administration date: 18Apr2021, when the patient was 17 years old, for COVID-19 immunisation. The following information was reported: OFF LABEL USE (non-serious), PRODUCT USE ISSUE (non-serious) all with onset 03Dec2021 15:30, outcome "unknown" and all described as "Flu shot received on 03Dec2021 and also received BNT162B2 on 03Dec2021"; IMMUNISATION (non-serious) with onset 03Dec2021 15:30, outcome "unknown", described as "Dose received: 3"; LYMPHADENOPATHY (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Swollen lymph nodes in neck and armpit"; URTICARIA (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Itchy hives on forehead, neck, legs"; NIGHT SWEATS (non-serious) with onset 04Dec2021, outcome "not recovered", described as "Night sweats". Therapeutic measures were taken as a result of lymphadenopathy, urticaria, night sweats. Additional information: The patient did not receive any other vaccines within four weeks prior to the prior to the COVID-19 vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The events did not result in doctor or other healthcare professional office/clinic visit and emergency room/department or urgent care. Treatment included unspecified oral Antihistamine, Ibuprofen and topical Cortisol. The patient also received FLU SHOT, administered in right arm, administration date: 03Dec2021 for immunization.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Lung disorder
Clinical narrative: lung issues; booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program. The reporter is the patient.  A 82 year-old female patient received bnt162b2 (BNT162B2), administration date 02Dec2021 (Batch/Lot number: unknown) at the age of 82 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), for Covid-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021, outcome "unknown", described as "booster"; LUNG DISORDER (non-serious), outcome "unknown", described as "lung issues". The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Vaccination site pain
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 29 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Dec2021 13:00 (Lot number: FJ8762) at the age of 29 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Comirnaty (Dose 2, Batch/Lot Number: EW1071), administration date: 26Apr2021, when the patient was 28 years old, for COVID-19 immunization; Comirnaty (Dose 1, Batch/Lot Number: EW0150), administration date: 05Apr2021, when the patient was 28 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 13:00, outcome "unknown", described as "booster"; VACCINATION SITE PAIN (non-serious) with onset 06Dec2021 15:00, outcome "not recovered", described as "Pain around the injection site on the left arm, which was the site of administration". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: No other vaccine in four-weeks. No other medications in two-weeks. No covid prior vaccination. No covid tested post vaccination. No Known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pruritus, Rash
Clinical narrative: Pfizer booster; I had a rash starting all over my body and its still here; it itches, its a crazy, crazy itch; my neck, side of my face, my back, my stomach, my arms and my legs; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 58 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 02Dec2021 17:45 (Lot number: 32030BD) at the age of 58 years as dose number unknown (booster), single for covid-19 immunisation. Relevant medical history included: "No" (unspecified if ongoing), notes: Patient History: No. The patient's concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 02Dec2021 17:45, outcome "unknown", described as "Pfizer booster"; RASH (non-serious) with onset Dec2021, outcome "not recovered", described as "I had a rash starting all over my body and its still here"; PRURITUS (non-serious) with onset Dec2021, outcome "unknown", described as "it itches, its a crazy, crazy itch; my neck, side of my face, my back, my stomach, my arms and my legs". Therapeutic measures were taken as a result of rash, pruritus.  Additional Information: It was reported that I am gonna call my doctor now because I have to I thought it would go away you know I have been putting lotion on and taking a Zyrtec (Treatment) everyday but this is now that's the fourth day and so I don't know I mean I hope it goes away I just need something for the itching so I am gonna call my doctor but I wanted you guys to know because that's really the only thing that happen with can be attributed to it.". Prior vaccinations (Within 4 weeks) was reported as none. Treatment: Consumer stated, "Yes I took Zyrtec, I have been taking a Zyrtec everyday and just I am putting cream Cetaphil moisturizer, Cetaphil moisturizing cream." And then so I am gonna call my doctor just to see if she can give something to stop the itching and then I will just tell her, I had already reported this so she doesn't have to do it again right?"  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Dysgeusia, Immunisation
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a sponsored program.   A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included COVID (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included Bnt162b2 (Dose 1), for COVID-19 immunization, reaction(s) food was more sour; Bnt162b2 (Dose 2), for COVID-19 immunization, reaction(s) The second, too salty. The following information was reported IMMUNISATION (non-serious), outcome unknown; DYSGEUSIA (non-serious), outcome unknown.  The patient had some strange side-effects with all 3 shots of the Pfizer vaccine. When patient had COVID, lost sense of taste for 5 months before it came back. Each time, for between 1-3 days after getting the shot, food tasted strange. With the first shot, food was more sour, the second, too salty, and with the last one, more bitter.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoacusis, Hypoaesthesia, Immunisation, Paraesthesia, Tinnitus
Clinical narrative: side of her face started going numb and tingling/numbness, tingling, and ringing in her ear was occurring on the right side; side of her face started going numb and tingling/numbness, tingling, and ringing in her ear was occurring on the right side; Ears started ringing/ringing in her ear was occurring on the right side; She just got the Pfizer Covid-19 booster; can't hear out of her ear good and it is like it is full of water; 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 female patient received bnt162b2 (BNT162B2, Solution for injection), administered in arm left, administration date 06Dec2021 16:30 (Lot number: 320308D) at the age of 34 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Batch/Lot number: EL9267, Expiry: May2021), administration date: 19Feb2021, when the patient was 33 years old, for COVID-19 immunization; Bnt162b2 (Dose 2, single, Batch/Lot number : EN6202, Expiry date : 30Jun201), administration date: 12Mar2021, when the patient was 33 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 06Dec2021 16:30, outcome unknown, described as She just got the Pfizer Covid-19 booster; TINNITUS (non-serious) with onset 06Dec2021 16:45, outcome not recovered, described as Ears started ringing/ringing in her ear was occurring on the right side; PARAESTHESIA (non-serious), HYPOAESTHESIA (non-serious) all with onset 06Dec2021 16:50, outcome not recovered and all described as side of her face started going numb and tingling/numbness, tingling, and ringing in her ear was occurring on the right side; HYPOACUSIS (non-serious) with onset 06Dec2021, outcome not recovered, described as can't hear out of her ear good and it is like it is full of water.  Additional information: Caller is a consumer that reported that she just got the Pfizer Covid-19 booster dose at 1630 and about 15 minutes after she got it she left and was driving home and reported that her ears started ringing when she left at 1645. HCP: Caller declined.  Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Postural orthostatic tachycardia syndrome
Clinical narrative: postural orthostatic tachycardia; booster; This is a spontaneous report received from non-contactable reporter(s) (Physician) from a representative.  An adult female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date Dec2021 (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 Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer: Unknown), for Covid-19 immunization; Covid-19 vaccine (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion, Manufacturer: Unknown), for Covid-19 immunization. The following information was reported POSTURAL ORTHOSTATIC TACHYCARDIA SYNDROME (non-serious) with onset Dec2021, outcome recovered; IMMUNISATION (non-serious) with onset Dec2021, outcome recovered. The event postural orthostatic tachycardia was evaluated at the physician office visit. Therapeutic measures were taken as a result of postural orthostatic tachycardia syndrome, immunisation.  The lot number for bnt162b2 was not provided and will be requested during follow up.  Doctor's office/urgent care was facility type vaccine. Other vaccine in four weeks was unknown. The patient was on low dose beta-blocker and it was feeling much better. AE treatment was beta-blocker. Covid prior vaccination was unknown. Covid tested post vaccination was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Immunisation
Clinical narrative: the booster; blood sugar rise; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP).  A female patient received bnt162b2 (Pfizer-BioNTech COVID-19), administration date 2021 (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization, reaction(s) Blood sugar rose after they've had the shots each time; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization, reaction(s) Blood sugar rose after they've had the shots each time. The following information was reported IMMUNISATION (non-serious) with onset 2021, outcome unknown; BLOOD GLUCOSE INCREASED (non-serious) with onset 2021, outcome unknown. Relevant laboratory tests and procedures are available in the appropriate section.  No follow-up attempts are possible, information about lot/batch number cannot be obtained. No further information is expected. Linked Report(s): US-PFIZER INC-202101742491 same vaccine, and different patient; US-PFIZER INC-202101742407 same vaccine, AE, and different patient; US-PFIZER INC-202101742765 same patient, different dose/AE. US-PFIZER INC-202101744009 same vaccine, AE, and different patient; US-PFIZER INC-202101744010 same vaccine, AE, and different patient.
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood glucose increased, Immunisation
Clinical narrative: booster; blood sugar rise; This is a spontaneous report received from a non-contactable reporter (Consumer or other non HCP).  A female patient received bnt162b2 (PFIZER-BIONTECH COVID-19 VACCINE) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTUERER UNKNOWN), for COVID-19 immunization, reaction(s): "blood sugar rise"; Covid-19 vaccine (DOSE 2; MANUFACTUERER UNKNOWN), for COVID-19 immunization, reaction(s): "Blood suger rise". The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; BLOOD GLUCOSE INCREASED (non-serious), outcome "unknown", described as "blood sugar rise". Relevant laboratory tests and procedures are available in the appropriate section.  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-202101742491 same patient, vaccine, AE and different dose;US-PFIZER INC-202101741528 same vaccine, AE and different patient;US-PFIZER INC-202101744010 same vaccine, AE and different patient;US-PFIZER INC-202101744009 same vaccine, AE and different patient;US-PFIZER INC-202101742765 same vaccine, AE and different patient
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Immunisation
Clinical narrative: she had diarrhea after the booster dose; after receiving the booster dose in Aug2021.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 83 year-old female patient received bnt162b2 (COMIRNATY), administration date Aug2021 (Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included COPD (unspecified if ongoing); immune problem (unspecified if ongoing), IgG infusions. The patient's concomitant medications were not reported. Vaccination history included Bnt162b2 (DOSE 1, SINGLE), for COVID-19 Immunization; Bnt162b2 (DOSE 2, SINGLE), for Covid-19 Immunization. The following information was reported DIARRHOEA (non-serious) with onset Aug2021, outcome unknown; IMMUNISATION (non-serious) with onset Aug2021, outcome unknown.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Electrocardiogram, Fatigue, Headache, Immunisation
Clinical narrative: Booster; Pain and stiffness in injection arm; Felt feverish but temperature never rose above 98.4; stiffness in injection arm; body aches; fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2) (Lot number: 320308D, Expiration Date: 15Nov2021) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Ulcerative colitis", start date: 2005 (ongoing), notes: 4 colonoscopies; "Osteoporosis", start date: 2017 (ongoing), notes: Dexa scans lifeline screenings (Hospital name); "Heart block", start date: 2019 (ongoing), notes: One stay (Hospital name) no treatment tests done EKG ECHs etc. Concomitant medication(s) included: 6-MERCAPTOPURINE MONOHYDRATE taken for colitis ulcerative, start date: Nov2005 (ongoing); ALENDRONATE taken for osteoporosis, start date: 2017 (ongoing). Vaccination history included: Bnt162b2 (Dose 1 , Prior vaccinations: Covid-19 vaccine vial, Manufacturer: Pfizer, Anatomical Site of Injection: Left arm, No. of previous doses: 2, Date: 16Nov2021), for COVID-19 Immunization; Bnt162b2 (Dose 2, Prior vaccinations: Covid-19 vaccine vial, Manufacturer: Pfizer, Anatomical Site of Injection: Left arm, No. of previous doses: 2, Date: 16Nov2021), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Pain and stiffness in injection arm"; PYREXIA (non-serious), outcome "recovered", described as "Felt feverish but temperature never rose above 98.4"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "recovered", described as "stiffness in injection arm"; PAIN (non-serious), outcome "recovered", described as "body aches"; FATIGUE (non-serious), outcome "recovered", described as "fatigue"; HEADACHE (non-serious), outcome "recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He had no private car and take city buses 5-6 days week. Took third COVID-19 Vaccination. Felt feverish but temperature never rise above 98.4 was not disturbed during sleep this time. Pain and stiffness in injection arm body aches fatigue headache. All symptoms resolved in about 30 hours. Now ready for omicron booster.  Follow-up attempts are completed. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Musculoskeletal stiffness, Pain, Pyrexia, Vaccination site pain
Clinical narrative: Booster; Pain and stiffness in injection arm; Felt feverish but temperature never rose above 98.4; stiffness in injection arm; body aches; fatigue; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 69 year-old male patient received bnt162b2 (BNT162B2) (Lot number: 320308D, Expiration Date: 15Nov2021) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Ulcerative colitis", start date: 2005 (ongoing), notes: 4 colonoscopies; "Osteoporosis", start date: 2017 (ongoing), notes: Dexa scans lifeline screenings (Hospital name); "Heart block", start date: 2019 (ongoing), notes: One stay (Hospital name) no treatment tests done EKG ECHs etc. Concomitant medication(s) included: 6-MERCAPTOPURINE MONOHYDRATE taken for colitis ulcerative, start date: Nov2005 (ongoing); ALENDRONATE taken for osteoporosis, start date: 2017 (ongoing). Vaccination history included: Bnt162b2 (Dose 1 , Prior vaccinations: Covid-19 vaccine vial, Manufacturer: Pfizer, Anatomical Site of Injection: Left arm, No. of previous doses: 2, Date: 16Nov2021), for COVID-19 Immunization; Bnt162b2 (Dose 2, Prior vaccinations: Covid-19 vaccine vial, Manufacturer: Pfizer, Anatomical Site of Injection: Left arm, No. of previous doses: 2, Date: 16Nov2021), for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "Booster"; VACCINATION SITE PAIN (non-serious), outcome "recovered", described as "Pain and stiffness in injection arm"; PYREXIA (non-serious), outcome "recovered", described as "Felt feverish but temperature never rose above 98.4"; MUSCULOSKELETAL STIFFNESS (non-serious), outcome "recovered", described as "stiffness in injection arm"; PAIN (non-serious), outcome "recovered", described as "body aches"; FATIGUE (non-serious), outcome "recovered", described as "fatigue"; HEADACHE (non-serious), outcome "recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: He had no private car and take city buses 5-6 days week. Took third COVID-19 Vaccination. Felt feverish but temperature never rise above 98.4 was not disturbed during sleep this time. Pain and stiffness in injection arm body aches fatigue headache. All symptoms resolved in about 30 hours. Now ready for omicron booster.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Chills, Fatigue, Headache, Immunisation
Clinical narrative: chills; Pain at injection site; pain neck and armpit (lymph nodes?); tired; headache; pain neck and armpit; pain neck and armpit (lymph nodes?); Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Dec2021 09:00 (Lot number: FH8027) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included high blood pressure (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 11:45 AM, Route of Administration: Intramuscular), administration date: 30Mar2021, when the patient was 44 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 12:45 PM, Route of Administration: Intramuscular), administration date: 09Mar2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported CHILLS (non-serious) with onset 06Dec2021 21:00, outcome recovering; VACCINATION SITE PAIN (non-serious) with onset 06Dec2021 21:00, outcome recovering; NECK PAIN (non-serious), LYMPH NODE PAIN (non-serious) all with onset 06Dec2021 21:00, outcome recovering; FATIGUE (non-serious) with onset 06Dec2021 21:00, outcome recovering; HEADACHE (non-serious) with onset 06Dec2021 21:00, outcome recovering; IMMUNISATION (non-serious) with onset 06Dec2021 09:00, outcome unknown; AXILLARY PAIN (non-serious) with onset 06Dec2021 21:00, outcome recovering. Therapeutic measures were not taken as a result of chills, vaccination site pain, neck pain, fatigue, headache, axillary pain, and lymph node pain.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Neck pain, Vaccination site pain
Clinical narrative: chills; Pain at injection site; pain neck and armpit (lymph nodes?); tired; headache; pain neck and armpit; pain neck and armpit (lymph nodes?); Booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). A 45 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 06Dec2021 09:00 (Lot number: FH8027) at the age of 45 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included high blood pressure (unspecified if ongoing). There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP6955, Location of injection: Arm Left, Vaccine Administration Time: 11:45 AM, Route of Administration: Intramuscular), administration date: 30Mar2021, when the patient was 44 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3247, Location of injection: Arm Left, Vaccine Administration Time: 12:45 PM, Route of Administration: Intramuscular), administration date: 09Mar2021, when the patient was 44 years old, for COVID-19 immunization. The following information was reported CHILLS (non-serious) with onset 06Dec2021 21:00, outcome recovering; VACCINATION SITE PAIN (non-serious) with onset 06Dec2021 21:00, outcome recovering; NECK PAIN (non-serious), LYMPH NODE PAIN (non-serious) all with onset 06Dec2021 21:00, outcome recovering; FATIGUE (non-serious) with onset 06Dec2021 21:00, outcome recovering; HEADACHE (non-serious) with onset 06Dec2021 21:00, outcome recovering; IMMUNISATION (non-serious) with onset 06Dec2021 09:00, outcome unknown; AXILLARY PAIN (non-serious) with onset 06Dec2021 21:00, outcome recovering. Therapeutic measures were not taken as a result of chills, vaccination site pain, neck pain, fatigue, headache, axillary pain, and lymph node pain.  Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient did not receive any medications within 2 weeks of vaccination. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19. Patient had no known allergies.  Follow-up attempts are completed. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, Headache, Immunisation, Pain, Pain in extremity
Clinical narrative: Got struck twice with the needle during vaccination; Arm hurts bad/ her left arm hurt; It did not hurt this bad with the two primary doses/her left arm hurt was reported as worsened; Headache; Two pin pricks; Booster; 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 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 07Dec2021 17:00 (Lot number: 33030BD) at the age of 55 years as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: Bnt162b2 (1st Dose), administration date: 2021, for COVID-19 Immunization, reaction(s): "It did not hurt this bad with the two primary doses"; Bnt162b2 (2nd Dose), administration date: 2021, for COVID-19 Immunization, reaction(s): "It did not hurt this bad with the two primary doses". The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021, outcome "unknown", described as "Booster"; CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (non-serious) with onset 07Dec2021 17:00, outcome "unknown", described as "Got struck twice with the needle during vaccination"; PAIN IN EXTREMITY (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Arm hurts bad/ her left arm hurt"; PAIN (non-serious) with onset 07Dec2021, outcome "not recovered", described as "It did not hurt this bad with the two primary doses/her left arm hurt was reported as worsened"; HEADACHE (non-serious) with onset 07Dec2021, outcome "not recovered", described as "Headache"; PAIN (non-serious) with onset 07Dec2021, outcome "unknown", described as "Two pin pricks". Therapeutic measures were taken as a result of pain in extremity, pain, headache, pain.  Additional information: Patient received the booster dose of the Pfizer BioNTech Covid-19 vaccine and got struck twice with the needle during vaccination. Patient would like to know if this was okay and if she should receive another shot. Patient stated her arm hurts bad, it did not hurt this bad with the two primary doses of the Covid-19 vaccine. Patient stated when she got home she looked under the band-aid and she could see two pin pricks just above one another. Patient stated she got struck with the needle twice and it happened so fast. Stated that she had lasting effects from being stuck with the need twice of her left arm hurting. Stated that her left arm started hurting on 07Dec2021 at 5pm when she had the shot. Stated that Ibuprofen does not help. Stated that she took one dose but is going to take another dose in 6 hours. Ibuprofen strength: 200 mg.  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Immunisation, Injection site swelling
Clinical narrative: Swelling in armpit of the injection arm.; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-health care professional).  A 49-years-old male patient received third dose of bnt162b2 (BNT162B2, Batch/Lot number: Unknown) intramuscular, administered in arm left, administration date 07Dec2021 09:30 (at the age of 49 years) as DOSE 3 (BOOSTER), SINGLE for covid-19 immunization. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included Bnt162b2 (DOSE NUMBER: 2, Location of injection: Arm Left, Vaccine Administration Time: 11:15 AM, Route of Administration: Intramuscular), administration date: 16Mar2021, when the patient was 49 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Location of injection: Arm Left, Vaccine Administration Time: 08:45 AM, Route of Administration: Intramuscular), administration date: 22Feb2021, when the patient was 49 years old, for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 07Dec2021 09:30, outcome unknown; INJECTION SITE SWELLING (non-serious) with onset 08Dec2021 12:00, outcome not recovered. Therapeutic measures were not taken as a result of injection site swelling.  The patient had no known allergies. The patient did not received any other vaccines within 4 weeks prior to the COVID-19 vaccine. No other medications were received within 2 weeks. Prior to vaccination, the patient was not diagnosed with COVID-19 and since the vaccination was not tested for COVID-19.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nail discolouration, Nail discomfort
Clinical narrative: booster; There is now a purple discoloration of the nail bed of the big toes, more on the left foot than the right; About one week after the most recent vaccination, my toenails were hurting at night when I was trying to sleep.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 61 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 26Nov2021 11:45 (Lot number: FJ1620) at the age of 61 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Osteoporosis" (unspecified if ongoing); "Known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: VITAMIN D; RECLAST. Past drug history included: Ampicillin, reaction(s): "Known allergies: Ampicillin"; Erythromycin, reaction(s): "Known allergies: Erythromycin". Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: ER8727, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), administration date: 22Mar2021, when the patient was 60 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: EW0151, Location of injection: Arm Left, Vaccine Administration Time: 12:15 PM), administration date: 12Apr2021, when the patient was 60 years old, for COVID-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 26Nov2021 11:45, outcome "unknown", described as "booster"; NAIL DISCOLOURATION (non-serious) with onset Nov2021, outcome "unknown", described as "There is now a purple discoloration of the nail bed of the big toes, more on the left foot than the right"; NAIL DISCOMFORT (non-serious) with onset Nov2021, outcome "unknown", described as "About one week after the most recent vaccination, my toenails were hurting at night when I was trying to sleep.". Therapeutic measures were not taken as a result of nail discolouration, nail discomfort.  Additional information: No, covid prior to vaccination, covid was not tested to post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Pruritus, Vaccination site pain, Vaccination site swelling
Clinical narrative: Site of injection had normal pain and swelling at first; Site of injection had normal pain and swelling at first; Itchy; Booster; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).   A 58 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 04Dec2021 07:30 (Batch/Lot number: unknown) at the age of 58 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included Allergy to shellfish (unspecified if ongoing); Allergy to Grapes (unspecified if ongoing); Allergy to penicillin (unspecified if ongoing); Allergy to Iodine (unspecified if ongoing). The patient took concomitant medications. Vaccination history included Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 01:30 PM), administration date: 07May2021, when the patient was 58 years old, for COVID-19 immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right, Vaccine Administration Time: 01:30 PM), administration date: 17Apr2021, when the patient was 57 years old, for COVID-19 immunization. The following information was reported IMMUNISATION (non-serious) with onset 04Dec2021 07:00, outcome unknown; VACCINATION SITE SWELLING (non-serious), VACCINATION SITE PAIN (non-serious) all with onset 04Dec2021 23:30, outcome recovering; PRURITUS (non-serious) with onset 04Dec2021 23:30, outcome not recovered. Therapeutic measures were not taken as a result of vaccination site swelling, vaccination site pain, pruritus. Additional info-It was reported that patient did not receive any other vaccine in four weeks. Patient did not suffer from covid prior vaccination and did not underwent covid tested post vaccination. It was also reported that patient medical history list was too long. Patient had experienced Site of injection had normal pain and swelling at first. Over the next days, the swollen, hard area spread to the size of my palm and became itchy. Now it has stopped growing larger, but is still itchy (4 days later). The lot number for bnt162b2 was not provided and will be requested during follow up.