chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Spinal pain, Vaccination site pain
Clinical narrative: headache; bilateral burning of ears; spinal pain from mid back to neck; numbness and tingling in the injection arm; numbness and tingling in the injection arm; pain at injection site; Booster; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP). The reporter is the patient.  A 38 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 10Jan2022 (Lot number: FD00809) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Asthma" (unspecified if ongoing); "latex allergy" (unspecified if ongoing); "PCN allergy" (unspecified if ongoing); "sulfa allergy" (unspecified if ongoing); "bee venom allergy" (unspecified if ongoing); "seasonal allergies" (unspecified if ongoing); "almonds allergy" (unspecified if ongoing). Concomitant medication(s) included: FLUCONAZOLE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; LOESTRIN. Past drug history included: Cefazolin, reaction(s): "Known allergies: cefazolin"; Midrin, reaction(s): "Known allergies: Midrin". Vaccination history included: Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EM9810, prev dose lot unknown=False, prev dose administration date=12Feb2021, prev dose dose number=2), administration date: 12Feb2021, when the patient was 38 years old, for COVID-19 immunization, reaction(s): "headache", "bilateral burning of ears", "spinal pain from mid back to neck", "numbness and tingling in the injection arm", "numbness and tingling in the injection arm"; Bnt162b2 (prev dose product=COVID 19, prev dose brand=Pfizer, prev dose brand unknown=False, prev dose lot number=EL3249, prev dose lot unknown=False, prev dose administration date=22Jan2021, prev dose dose number=1), administration date: 22Jan2021, when the patient was 38 years old, for COVID-19 immunization, reaction(s): "headache", "bilateral burning of ears", "spinal pain from mid back to neck", "numbness and tingling in the injection arm", "numbness and tingling in the injection arm". The following information was reported: IMMUNISATION (non-serious) with onset 10Jan2022, outcome "unknown", described as "Booster"; HEADACHE (non-serious) with onset 10Jan2022 14:00, outcome "unknown", described as "headache"; EAR DISCOMFORT (non-serious) with onset 10Jan2022 14:00, outcome "unknown", described as "bilateral burning of ears"; SPINAL PAIN (non-serious) with onset 10Jan2022 14:00, outcome "unknown", described as "spinal pain from mid back to neck"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 10Jan2022 14:00, outcome "unknown" and all described as "numbness and tingling in the injection arm"; VACCINATION SITE PAIN (non-serious) with onset 10Jan2022 14:00, outcome "unknown", described as "pain at injection site". It was unknown if therapeutic measures were taken as a result of headache, ear discomfort, spinal pain, hypoaesthesia, paraesthesia, vaccination site pain. No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Fatigue, Off label use, Pain, Product use issue, Rhinorrhoea
Clinical narrative: he received his Pfizer Covid-19 booster vaccine and an influenza vaccine (manufacturer unknown by the reporter) on Wednesday; sneezy achy fatigue had sniffles; sneezy achy fatigue had sniffles; sneezy achy fatigue had sniffles; sneezy achy fatigue had sniffles; he received his Pfizer Covid-19 booster vaccine and an influenza vaccine (manufacturer unknown by the reporter) on Wednesday; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 29Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administration date 29Dec2021 (Batch/Lot number: unknown). 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: PRODUCT USE ISSUE (non-serious) with onset 29Dec2021, outcome "unknown", SNEEZING (non-serious), PAIN (non-serious), FATIGUE (non-serious), RHINORRHOEA (non-serious) all with onset 30Dec2021, outcome "unknown" and all described as "sneezy achy fatigue had sniffles"; OFF LABEL USE (non-serious), outcome "unknown", described as "he received his Pfizer Covid-19 booster vaccine and an influenza vaccine (manufacturer unknown by the reporter) on Wednesday". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Sneezing
Clinical narrative: he received his Pfizer Covid-19 booster vaccine and an influenza vaccine (manufacturer unknown by the reporter) on Wednesday; sneezy achy fatigue had sniffles; sneezy achy fatigue had sniffles; sneezy achy fatigue had sniffles; sneezy achy fatigue had sniffles; he received his Pfizer Covid-19 booster vaccine and an influenza vaccine (manufacturer unknown by the reporter) on Wednesday; This is a spontaneous report received from contactable reporter(s) (Physician). The reporter is the patient.  A male patient received bnt162b2 (BNT162B2), administration date 29Dec2021 (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA VACCINE), administration date 29Dec2021 (Batch/Lot number: unknown). 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: PRODUCT USE ISSUE (non-serious) with onset 29Dec2021, outcome "unknown", SNEEZING (non-serious), PAIN (non-serious), FATIGUE (non-serious), RHINORRHOEA (non-serious) all with onset 30Dec2021, outcome "unknown" and all described as "sneezy achy fatigue had sniffles"; OFF LABEL USE (non-serious), outcome "unknown", described as "he received his Pfizer Covid-19 booster vaccine and an influenza vaccine (manufacturer unknown by the reporter) on Wednesday". The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: She stated she is sicker than a dog; 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 58 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose1, Manufacturer Unknown), for COVID-19 Immunization; Covid-19 vaccine (Dose2, Manufacturer Unknown), for COVID-19 Immunization. The following information was reported: ILLNESS (non-serious), outcome "unknown", described as "She stated she is sicker than a dog".  Additional information: The reporter stated that she received a Pfizer Covid vaccine booster dose and was having a reaction. She stated she was sicker than a dog. She wants to know what she should do about her reaction to manage it. She was going to follow up with treating hcp for medical advice. The reporter was provided with response: Pfizer was unable to make treatment recommendations and was referred to treating hcp/vaccinator and/or local Emergency Dept. Doctor/healthcare provider was in the best position to advise about the appropriate action to take as doctor/healthcare provider are most familiar with medical condition, clinical history, how treatment has been conducted and any relevant information to specific case.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Hyperhidrosis, Oropharyngeal pain
Clinical narrative: sore throat; sweating; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non-HCP) for a Pfizer sponsored program. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunization. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, single), for Covid-19 immunization; Covid-19 vaccine (Dose 2, single), for Covid-19 immunization. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "sore throat"; HYPERHIDROSIS (non-serious), outcome "unknown", described as "sweating".  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Dysgeusia
Clinical narrative: The third dose she had a metallic taste from the first dose; 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 42 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single, (Batch/Lot number: unknown) as dose 2, single and (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. The following information was reported: DYSGEUSIA (non-serious), outcome "unknown", described as "The third dose she had a metallic taste from the first dose".  Additional Information: The Product is PAXLOVID.Caller started her Paxlovid medication on 11Jan2022 and is having side effects. Caller states that she is in a lot of stress and is having black stool and feeling very weak. In the first couple of days she feels better, very good and just a little tired. On the third dose she had a metallic taste from the first dose. Caller is stopping her medication today. Caller states that she is taking a lot of food supplements and has a weak liver. She mentioned that her HCP never told her that she can't take supplements. Caller wants to go cold turkey on her medication. Caller is most concerned if "black stool" is a reported side effect of her medication.  Follow up attempts were closed. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea
Clinical narrative: booster; nauseous; This is a spontaneous report received from contactable reporter(s) (Other HCP) for a Pfizer sponsored program (141003).  A 53 year-old female patient received COVID-19 Vaccine - Manufacturer Unknown, (Batch/Lot number: unknown) as dose number unknown (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Manufacturer unknown), for COVID-19 immunization.  The following information was reported: IMMUNISATION (non-serious), outcome "unknown", described as "booster"; NAUSEA (non-serious), outcome "recovered", described as "nauseous".  The lot number for COVID-19 Vaccine - Manufacturer Unknown was not provided and will be requested during follow up.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Memory impairment, Vaccination site discomfort
Clinical narrative: he had some discomfort around the injection site.; he thinks it is he that is getting affected when he was providing his address because he had trouble remembering his address and Zip code; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 51 year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 12Jan2022 (Batch/Lot number: unknown) at the age of 51 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: Covid-19 vaccine (Dose 1, MANUFACTURER UNKNOWN), for Covid-19 Immunization; Covid-19 vaccine (Dose 2, MANUFACTURER UNKNOWN), for Covid-19 Immunization. The following information was reported: VACCINATION SITE DISCOMFORT (non-serious) with onset Jan2022, outcome "unknown", described as "he had some discomfort around the injection site."; MEMORY IMPAIRMENT (non-serious) with onset Jan2022, outcome "unknown", described as "he thinks it is he that is getting affected when he was providing his address because he had trouble remembering his address and Zip code".  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Blood urea increased, Dysuria, Full blood count, Glomerular filtration rate, Glomerular filtration rate decreased
Clinical narrative: I had the vaccine I urinated in my sleep; my urea nitrogen was high; I had excess protein in my urine; GFR decreased; my kidneys are having some issues; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Dec2021 (Lot number: FL3197) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "immune compromise issues" (unspecified if ongoing), notes: I still don't have a diagnosis.I just have seen a lot of doctor I just have some immune issues some sort, I have had some problems like other viruses like Epstein-Barr virus really severely complications because its my immune system. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: 30Apr2021, when the patient was 33 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2), administration date: 21May2021, when the patient was 33 years old, for Covid-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 26Dec2021, outcome "unknown", described as "booster"; DYSURIA (non-serious), outcome "not recovered", described as "I had the vaccine I urinated in my sleep"; BLOOD UREA INCREASED (non-serious), outcome "not recovered", described as "my urea nitrogen was high"; PROTEIN URINE PRESENT (non-serious), outcome "not recovered", described as "I had excess protein in my urine"; GLOMERULAR FILTRATION RATE DECREASED (non-serious), outcome "not recovered", described as "GFR decreased"; RENAL DISORDER (non-serious), outcome "not recovered", described as "my kidneys are having some issues". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysuria, blood urea increased, protein urine present, glomerular filtration rate decreased, renal disorder.  Follow-Up (19Jan2022):Follow-up attempts are completed. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Metabolic function test, Protein urine present, Renal disorder
Clinical narrative: I had the vaccine I urinated in my sleep; my urea nitrogen was high; I had excess protein in my urine; GFR decreased; my kidneys are having some issues; booster; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 33 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 26Dec2021 (Lot number: FL3197) at the age of 33 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "immune compromise issues" (unspecified if ongoing), notes: I still don't have a diagnosis.I just have seen a lot of doctor I just have some immune issues some sort, I have had some problems like other viruses like Epstein-Barr virus really severely complications because its my immune system. There were no concomitant medications. Vaccination history included: Bnt162b2 (Dose 1), administration date: 30Apr2021, when the patient was 33 years old, for Covid-19 Immunization; Bnt162b2 (Dose 2), administration date: 21May2021, when the patient was 33 years old, for Covid-19 Immunization.  The following information was reported: IMMUNISATION (non-serious) with onset 26Dec2021, outcome "unknown", described as "booster"; DYSURIA (non-serious), outcome "not recovered", described as "I had the vaccine I urinated in my sleep"; BLOOD UREA INCREASED (non-serious), outcome "not recovered", described as "my urea nitrogen was high"; PROTEIN URINE PRESENT (non-serious), outcome "not recovered", described as "I had excess protein in my urine"; GLOMERULAR FILTRATION RATE DECREASED (non-serious), outcome "not recovered", described as "GFR decreased"; RENAL DISORDER (non-serious), outcome "not recovered", described as "my kidneys are having some issues". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of dysuria, blood urea increased, protein urine present, glomerular filtration rate decreased, renal disorder.  Follow-Up (19Jan2022):Follow-up attempts are completed. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Blood pressure measurement, Chest pain, Eye pain, Fatigue
Clinical narrative: hypertension upon standing (up to 165/120) which can resolve upon sitting; eye pain; tingling in hands and feet; ringing in her ears; crushing chest pain; pain in her neck; pain in her back; pain in her hands and feet; lymphadenopathy in her neck on the same side as the injection; lymphadenopathy in her neck on the same side as the injection, which is painful to touch; headache; fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP). A female patient received bnt162b2 (BNT162B2), administration date 06Jan2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hyperadrenergic POTS" (unspecified if ongoing), notes: living for years with Hyperadrenergic POTS (Postural tachycardia syndrome); "Thoracic Outlet Syndrome" (unspecified if ongoing), notes: living for years with Thoracic Outlet Syndrome. The patient's concomitant medications were not reported. The following information was reported: ORTHOSTATIC HYPERTENSION (non-serious) with onset Jan2022, outcome "unknown", described as "hypertension upon standing (up to 165/120) which can resolve upon sitting"; EYE PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "eye pain"; PARAESTHESIA (non-serious) with onset Jan2022, outcome "unknown", described as "tingling in hands and feet"; TINNITUS (non-serious) with onset Jan2022, outcome "unknown", described as "ringing in her ears"; CHEST PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "crushing chest pain"; NECK PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "pain in her neck"; BACK PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "pain in her back"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "pain in her hands and feet"; LYMPHADENOPATHY (non-serious) with onset Jan2022, outcome "unknown", described as "lymphadenopathy in her neck on the same side as the injection"; LYMPH NODE PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "lymphadenopathy in her neck on the same side as the injection, which is painful to touch"; HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset Jan2022, outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She received the Pfizer Covid Vaccine for the first time about a week ago (06Jan2022). Post-vaccine (ranging times of onset) she developed symptoms. She reported that some symptoms started within 3-4 days of the vaccine, and some started earlier. She was obviously quite upset and was in tears on the call.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, Neck pain, Orthostatic hypertension
Clinical narrative: hypertension upon standing (up to 165/120) which can resolve upon sitting; eye pain; tingling in hands and feet; ringing in her ears; crushing chest pain; pain in her neck; pain in her back; pain in her hands and feet; lymphadenopathy in her neck on the same side as the injection; lymphadenopathy in her neck on the same side as the injection, which is painful to touch; headache; fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP). A female patient received bnt162b2 (BNT162B2), administration date 06Jan2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hyperadrenergic POTS" (unspecified if ongoing), notes: living for years with Hyperadrenergic POTS (Postural tachycardia syndrome); "Thoracic Outlet Syndrome" (unspecified if ongoing), notes: living for years with Thoracic Outlet Syndrome. The patient's concomitant medications were not reported. The following information was reported: ORTHOSTATIC HYPERTENSION (non-serious) with onset Jan2022, outcome "unknown", described as "hypertension upon standing (up to 165/120) which can resolve upon sitting"; EYE PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "eye pain"; PARAESTHESIA (non-serious) with onset Jan2022, outcome "unknown", described as "tingling in hands and feet"; TINNITUS (non-serious) with onset Jan2022, outcome "unknown", described as "ringing in her ears"; CHEST PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "crushing chest pain"; NECK PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "pain in her neck"; BACK PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "pain in her back"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "pain in her hands and feet"; LYMPHADENOPATHY (non-serious) with onset Jan2022, outcome "unknown", described as "lymphadenopathy in her neck on the same side as the injection"; LYMPH NODE PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "lymphadenopathy in her neck on the same side as the injection, which is painful to touch"; HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset Jan2022, outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She received the Pfizer Covid Vaccine for the first time about a week ago (06Jan2022). Post-vaccine (ranging times of onset) she developed symptoms. She reported that some symptoms started within 3-4 days of the vaccine, and some started earlier. She was obviously quite upset and was in tears on the call.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Paraesthesia, Tinnitus
Clinical narrative: hypertension upon standing (up to 165/120) which can resolve upon sitting; eye pain; tingling in hands and feet; ringing in her ears; crushing chest pain; pain in her neck; pain in her back; pain in her hands and feet; lymphadenopathy in her neck on the same side as the injection; lymphadenopathy in her neck on the same side as the injection, which is painful to touch; headache; fatigue; This is a spontaneous report received from contactable reporter(s) (Other HCP). A female patient received bnt162b2 (BNT162B2), administration date 06Jan2022 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "Hyperadrenergic POTS" (unspecified if ongoing), notes: living for years with Hyperadrenergic POTS (Postural tachycardia syndrome); "Thoracic Outlet Syndrome" (unspecified if ongoing), notes: living for years with Thoracic Outlet Syndrome. The patient's concomitant medications were not reported. The following information was reported: ORTHOSTATIC HYPERTENSION (non-serious) with onset Jan2022, outcome "unknown", described as "hypertension upon standing (up to 165/120) which can resolve upon sitting"; EYE PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "eye pain"; PARAESTHESIA (non-serious) with onset Jan2022, outcome "unknown", described as "tingling in hands and feet"; TINNITUS (non-serious) with onset Jan2022, outcome "unknown", described as "ringing in her ears"; CHEST PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "crushing chest pain"; NECK PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "pain in her neck"; BACK PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "pain in her back"; PAIN IN EXTREMITY (non-serious) with onset Jan2022, outcome "unknown", described as "pain in her hands and feet"; LYMPHADENOPATHY (non-serious) with onset Jan2022, outcome "unknown", described as "lymphadenopathy in her neck on the same side as the injection"; LYMPH NODE PAIN (non-serious) with onset Jan2022, outcome "unknown", described as "lymphadenopathy in her neck on the same side as the injection, which is painful to touch"; HEADACHE (non-serious) with onset Jan2022, outcome "unknown", described as "headache"; FATIGUE (non-serious) with onset Jan2022, outcome "unknown", described as "fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She received the Pfizer Covid Vaccine for the first time about a week ago (06Jan2022). Post-vaccine (ranging times of onset) she developed symptoms. She reported that some symptoms started within 3-4 days of the vaccine, and some started earlier. She was obviously quite upset and was in tears on the call.   The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; fatigue; body aches; sore arm; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Jan2022 15:00 (Lot number: FJ5682) at the age of 16 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 (Dose Number: 2, Batch/Lot No: EW0187, Route of Administration: Intramuscular), administration date: 13Jun2021, when the patient was 15 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0178, Route of Administration: Intramuscular), administration date: 23May2021, when the patient was 15 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 13Jan2022, outcome "not recovered", described as "Fever"; FATIGUE (non-serious) with onset 13Jan2022, outcome "not recovered", described as "fatigue"; PAIN (non-serious) with onset 13Jan2022, outcome "not recovered", described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 13Jan2022, outcome "not recovered", described as "sore arm"; HEADACHE (non-serious) with onset 13Jan2022, outcome "not recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, fatigue, pain, pain in extremity, headache.  Additional information: The patient did not received any other vaccine with 4 weeks prior to vaccine. The patient did not received any other vaccine with 2 weeks prior to vaccine. The patient did not had COVID prior to vaccine. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Fever; fatigue; body aches; sore arm; headache; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 16 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 12Jan2022 15:00 (Lot number: FJ5682) at the age of 16 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 (Dose Number: 2, Batch/Lot No: EW0187, Route of Administration: Intramuscular), administration date: 13Jun2021, when the patient was 15 years old, for COVID-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0178, Route of Administration: Intramuscular), administration date: 23May2021, when the patient was 15 years old, for COVID-19 immunization. The following information was reported: PYREXIA (non-serious) with onset 13Jan2022, outcome "not recovered", described as "Fever"; FATIGUE (non-serious) with onset 13Jan2022, outcome "not recovered", described as "fatigue"; PAIN (non-serious) with onset 13Jan2022, outcome "not recovered", described as "body aches"; PAIN IN EXTREMITY (non-serious) with onset 13Jan2022, outcome "not recovered", described as "sore arm"; HEADACHE (non-serious) with onset 13Jan2022, outcome "not recovered", described as "headache". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of pyrexia, fatigue, pain, pain in extremity, headache.  Additional information: The patient did not received any other vaccine with 4 weeks prior to vaccine. The patient did not received any other vaccine with 2 weeks prior to vaccine. The patient did not had COVID prior to vaccine. No known allergies.  No follow-up attempts are possible. No further information is expected.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Off label use, Swelling
Clinical narrative: Swelling around collarbone area and under left arm; Dose:1 and Dose:2 Moderna, Dose:3 Pfizer; Dose:1 and Dose:2 Moderna, Dose:3 Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 11Jan2022 09:00 (Lot number: Fl3197) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "known allergies: Penicillin" (unspecified if ongoing); "known allergies: Sulfa" (unspecified if ongoing). Concomitant medication(s) included: CITALOPRAM. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Right), administration date: 08Apr2021, when the patient was 65 years old, for COVID-19 Immunization; Moderna (Dose Number: 1, Batch/Lot No: 001B21A, Location of injection: Arm Right), administration date: 11Mar2021, when the patient was 65 years old, for COVID-19 Immunization. The following information was reported: OFF LABEL USE (non-serious), INTERCHANGE OF VACCINE PRODUCTS (non-serious) all with onset 11Jan2022 09:00, outcome "unknown" and all described as "Dose:1 and Dose:2 Moderna, Dose:3 Pfizer"; SWELLING (non-serious) with onset 13Jan2022 12:00, outcome "not recovered", described as "Swelling around collarbone area and under left arm". The event "swelling around collarbone area and under left arm" was evaluated at the physician office visit. It was unknown if therapeutic measures were taken as a result of swelling.  Additional information: Other vaccine in four weeks was reported as no. Patient was not covid prior vaccination and did not test for covid post vaccination.   No follow-up attempts are possible. No further information is expected.
Age: 37.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, SARS-CoV-2 test, Scab
Clinical narrative: Rash and itching at the injection site which is still present after 4 weeks, as well as scabbing.; Rash and itching at the injection site which is still present after 4 weeks, as well as scabbing.; Rash and itching at the injection site which is still present after 4 weeks, as well as scabbing.; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 37 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 (Lot number: FH8027) at the age of 37 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Hypothyroidism" (unspecified if ongoing); "Allergies: Cephalosporins" (unspecified if ongoing); "Allergies: wasp sting" (unspecified if ongoing); "Allergies: latex" (unspecified if ongoing); "Allergies: nickel" (unspecified if ongoing); "Allergies: tree pollen" (unspecified if ongoing); "depression" (unspecified if ongoing); "anxiety" (unspecified if ongoing). Concomitant medication(s) included: SYNTHROID; LIOTHYRONINE; WELLBUTRIN; LEXAPRO; ZYRTEC [CETIRIZINE HYDROCHLORIDE]. Vaccination history included: Bnt162b2 (COVID 19, lot number EN6202, administration date 26Feb2021, dose number 2, vaccine location Left arm), administration date: 26Feb2021, when the patient was 36 years old, for COVID-19 immunization; Bnt162b2 (COVID 19, lot number EM9809, administration date 05Feb2021, dose number 1, vaccine location Left arm), administration date: 05Feb2021, when the patient was 36 years old, for COVID-19 immunization; Flu shot (other vaccine 4weeks product=Flu shot, vaccine date 09Nov2021, dose number 1, vaccine location left deltoid), administration date: 09Nov2021, when the patient was 37 years old, for Immunization. The following information was reported: RASH (non-serious), PRURITUS (non-serious), SCAB (non-serious) all with onset 15Dec2021, outcome "not recovered" and all described as "Rash and itching at the injection site which is still present after 4 weeks, as well as scabbing.". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of rash, pruritus, scab.  Additional Information: Facility type vaccine Doctor's office/urgent care, other vaccine in four weeks: Yes. Other vaccine 4weeks product was Flu shot on left deltoid on 09Nov2021 as dose 1.other medications in two weeks: Synthroid, Liothyronine, Wellbutrin, Lexapro, Zyrt. Known allergies to Cephalosporins, wasp sting, latex, nickel, tree pollen. Other medical history included Hypothyroidism, depression, anxiety  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lethargy, Vaccination site pain
Clinical narrative: lethargy; headache; injection site pain; exhaustion; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 30 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 13Jan2022 18:00 (Lot number: fj5682) at the age of 30 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "neuropathy" (unspecified if ongoing); "ocd" (unspecified if ongoing); "narcolepsy" (unspecified if ongoing); "sulfa drugs allergy" (unspecified if ongoing). Concomitant medication(s) included: LUVOX CR; OMEPRAZOLE; NUVIGIL; XYREM. Past drug history included: Codeine, reaction(s): "allergy"; Ceclor, reaction(s): "allergy"; Hydrocodone, reaction(s): "allergy". Vaccination history included: Bnt162b2 (Dose 2, Batch/Lot No: ew0196, Location of injection: Arm Left, Vaccine Administration Time: 07:00 PM, Route of Administration: Intramuscular), administration date: 25Jun2021, when the patient was 30 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot No: ew0180, Location of injection: Arm Left, Vaccine Administration Time: 07:00 PM, Route of Administration: Intramuscular), administration date: 04Jun2021, when the patient was 29 years old, for COVID-19 immunization. The following information was reported: LETHARGY (non-serious) with onset 14Jan2022, outcome "recovering", described as "lethargy"; HEADACHE (non-serious) with onset 14Jan2022, outcome "recovering", described as "headache"; VACCINATION SITE PAIN (non-serious) with onset 14Jan2022, outcome "recovering", described as "injection site pain"; FATIGUE (non-serious) with onset 14Jan2022, outcome "recovering", described as "exhaustion". Therapeutic measures were not taken as a result of lethargy, headache, vaccination site pain, fatigue.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19, UNK
Symptoms: Arthralgia, Fatigue
Clinical narrative: Arthritic pains; fatigue; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. Other Case identifier(s): 22K-163-4226476-00.  A 57 year-old male patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 2 (booster), single for covid-19 immunisation; adalimumab (HUMIRA), subcutaneous (Batch/Lot number: unknown) for rheumatoid arthritis. Relevant medical history included: "Influenza" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Janssen (DOSE 1, JANSSEN COVID-19 VACCINE (COVID-19 VACCINE NRVV AD26 (JNJ 78436735)) (COVID-19 VACCINE NRVV AD26), Daily Dose: (1 in 1 Once), Route of Administration: Intra-muscular, Indications for Use: PROPHYLACTIC VACCINATION, Therapy Dates (From/to): Unk), for COVID-19 immunization; Janseen (PFIZER BIONTECH COVID-19 VACCINE(TOZINAMERAN)(TOZINAMERAN), UNKNOWN, Daily Dose: 1) Booster dose (1 in 1 Once), Route of Admin: 1) Intra-muscular, Indication for use: 1) PROPHYLACTIC VACCINATION). The following information was reported: ARTHRALGIA (non-serious), outcome "unknown", described as "Arthritic pains"; FATIGUE (non-serious), outcome "recovered", described as "fatigue". The action taken for adalimumab was unknown.  No follow-up attempts are needed; information about lot/batch number cannot be obtained. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Heart rate increased, Limb discomfort, Lymphadenopathy, Mobility decreased
Clinical narrative: Substantial arm pain, can't lift above chest level with considerable effort; Rapid heart rate; Substantial arm pain, can't lift above chest level with considerable effort; Substantial arm pain, can't lift above chest level with considerable effort; Swollen and tender lymph nodes in right armpit; Swollen and tender lymph nodes in right armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Jan2022 10:15 (Lot number: 331308A) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN C [ASCORBIC ACID]. Vaccination history included: Bnt162b2 (Dose 2, Location of injection: Arm Left), administration date: 01May2021, when the patient was 42 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot No: ER8731, Location of injection: Arm Left), administration date: 09Apr2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: MOBILITY DECREASED (non-serious), PAIN IN EXTREMITY (non-serious), LIMB DISCOMFORT (non-serious) all with onset Jan2022, outcome "not recovered" and all described as "Substantial arm pain, can't lift above chest level with considerable effort"; HEART RATE INCREASED (non-serious) with onset Jan2022, outcome "not recovered", described as "Rapid heart rate"; AXILLARY PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset Jan2022, outcome "not recovered" and all described as "Swollen and tender lymph nodes in right armpit". Therapeutic measures were not taken as a result of mobility decreased, heart rate increased, pain in extremity, limb discomfort, axillary pain, lymphadenopathy.  Additional information: List of other medications the patient received within 2 weeks of vaccination were generic zyrtec, 1000 mg vitamin c, Fiber well. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Substantial arm pain, can't lift above chest level with considerable effort; Rapid heart rate; Substantial arm pain, can't lift above chest level with considerable effort; Substantial arm pain, can't lift above chest level with considerable effort; Swollen and tender lymph nodes in right armpit; Swollen and tender lymph nodes in right armpit; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 42 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 13Jan2022 10:15 (Lot number: 331308A) at the age of 42 years as dose 3 (booster), single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: ZYRTEC [CETIRIZINE HYDROCHLORIDE]; VITAMIN C [ASCORBIC ACID]. Vaccination history included: Bnt162b2 (Dose 2, Location of injection: Arm Left), administration date: 01May2021, when the patient was 42 years old, for COVID-19 immunization; Bnt162b2 (Dose 1, Batch/Lot No: ER8731, Location of injection: Arm Left), administration date: 09Apr2021, when the patient was 42 years old, for COVID-19 immunization. The following information was reported: MOBILITY DECREASED (non-serious), PAIN IN EXTREMITY (non-serious), LIMB DISCOMFORT (non-serious) all with onset Jan2022, outcome "not recovered" and all described as "Substantial arm pain, can't lift above chest level with considerable effort"; HEART RATE INCREASED (non-serious) with onset Jan2022, outcome "not recovered", described as "Rapid heart rate"; AXILLARY PAIN (non-serious), LYMPHADENOPATHY (non-serious) all with onset Jan2022, outcome "not recovered" and all described as "Swollen and tender lymph nodes in right armpit". Therapeutic measures were not taken as a result of mobility decreased, heart rate increased, pain in extremity, limb discomfort, axillary pain, lymphadenopathy.  Additional information: List of other medications the patient received within 2 weeks of vaccination were generic zyrtec, 1000 mg vitamin c, Fiber well. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Pyrexia, SARS-CoV-2 test
Clinical narrative: had a little fever last night; felt a little yucky yesterday; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (BNT162B2), administration date 13Jan2022 (Batch/Lot number: unknown) as dose 3, (booster) single for covid-19 immunisation. Relevant medical history included: "he has autoimmune disease" (unspecified if ongoing); "her husband and her got sick with COVID", start date: Jul2021 (unspecified if ongoing), notes: got sick with COVID, she says treatment for the COVID-19 was offered to her husband; "had brain fog for two months" (unspecified if ongoing); "they were sick for three weeks" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1), administration date: Feb2021, for COVID-19 Immunization; Bnt162b2 (Dose 2), administration date: Mar2021, for COVID-19 Immunization. The following information was reported: PYREXIA (non-serious) with onset 13Jan2022, outcome "unknown", described as "had a little fever last night"; NAUSEA (non-serious) with onset 13Jan2022, outcome "unknown", described as "felt a little yucky yesterday". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: She said she and her husband got sick within a couple hours of each other, and when they went to get tested, he tested positive and she was negative. She said the only thing they figured out was that she must have been a couple hours behind him and did not have enough when she tested positive. She said they were running fevers and had aches. She clarifies they did the COVID test in August, the COVID test done in the nose, whatever that is. She said treatment for the COVID-19 was offered to her husband, the infusion, because he has autoimmune disease. She says because she tested negative and didn't feel like going back to be tested again the next day, she didn't get offered any treatment, she said her husband didn't take the test, clarified to infusion, because he would have to go to the hospital for that and he didn't want to expose anyone or go anywhere. She said they recovered from COVID, and she was back to normal until Monday when she took the booster dose. Caller declines to complete a report for her husband, she said his side effects were different for him and she wouldn't want to give something wrong. She said her husband got his booster yesterday and felt a little yucky yesterday and had a little fever last night, and then was good to go today, he was a withheld.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation, Nausea, Pyrexia
Clinical narrative: dose number: 3; Fever; Nausea; This is a spontaneous report received from a non-contactable reporter(s) (Other HCP).  A 43 year-old female patient (unknown if pregnant) received bnt162b2 (BNT162B2), administration date 12Jan2022 (Lot number: FD7218) at the age of 43 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: Moderna (Dose Number: 2), for Covid-19 Immunization; Moderna (Dose Number: 1), for Covid-19 Immunization. The following information was reported: IMMUNISATION (non-serious) with onset 12Jan2022, outcome "unknown", described as "dose number: 3"; PYREXIA (non-serious) with onset Jan2022, outcome "unknown", described as "Fever"; NAUSEA (non-serious) with onset Jan2022, outcome "unknown", described as "Nausea".  No follow-up attempts are possible. No further information is expected.