chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site erythema
Clinical narrative: redness at the injection site; arm was sore initially; 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 71 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in arm right, administration date 18Oct2021 15:00 (Lot number: FF8635) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "pain" (unspecified if ongoing); "osteoporosis", start date: 1999 (ongoing); "constipation" (unspecified if ongoing); "Hypothyroidism", start date: 1976 (ongoing); "Spinal stenosis" (ongoing); "spine curvature" (ongoing); "2 back surgeries", start date: 2014 (unspecified if ongoing); "Thyroidectomy", start date: 1993 (unspecified if ongoing); "Pain-Back" (unspecified if ongoing). Concomitant medication(s) included: LEVOTHYROXINE taken for hypothyroidism (ongoing); ACETAMINOPHEN;HYDROCODONE taken for pain, back pain (ongoing); ALENDRONATE SODIUM taken for osteoporosis (ongoing); SENNA PLUS [DOCUSATE SODIUM;SENNOSIDE A+B] taken for constipation (ongoing). Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Time: 12:00 PM, Anatomical site of Injection: Right Arm, Rout of administration: intramuscular, Batch/Lot number: EJ1685 PFIZER, Dose: 1st, Time (24hr): 01:00 PM), administration date: 15Jan2021, when the patient was 71 years old, for COVID-19 Immunization, reaction(s): "had no issue"; Bnt162b2 (DOSE 2, SINGLE, Time: 12:00 PM, Anatomical site of Injection: Right Arm, Rout of administration: intramuscular, Batch/Lot number: EN5318 Biotech Pfizer, Dose: 2nd, Time (24hr): Approx. 12:30 PM), administration date: 05Feb2021, when the patient was 71 years old, for COVID-19 Immunization, reaction(s): "had no issue"; Flu vaccine, for Immunization. The following information was reported: VACCINATION SITE ERYTHEMA (non-serious) with onset 19Oct2021, outcome "recovered" (2021), described as "redness at the injection site"; PAIN IN EXTREMITY (non-serious) with onset 19Oct2021, outcome "recovered" (2021), described as "arm was sore initially". Therapeutic measures were not taken as a result of vaccination site erythema. Therapeutic measures were taken as a result of pain in extremity.  Additional information: Caller states she has put ice on the effected area. No prior vaccinations within 4 Weeks.  Follow-up attempts are completed. No further information is expected.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia, Tinnitus
Clinical narrative: experiencing a hissing water running ringing in her head; she can not sleep at night; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team for a Pfizer sponsored program. The reporter is the patient.  A 86 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 20Apr2021 (Batch/Lot number: unknown) at the age of 86 years as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose:1, Anatomical Site of injection: Arm (Left), Batch/Lot number: Unable to locate read the details , Not legible), administration date: 20Mar2021, when the patient was 86 years old, for COVID-19 Immunization. The following information was reported: TINNITUS (non-serious) with onset Apr2021, outcome "unknown", described as "experiencing a hissing water running ringing in her head"; INSOMNIA (non-serious) with onset Apr2021, outcome "unknown", described as "she can not sleep at night".  Additional information: States she has a caller on the line calling about the Pfizer COVID Vaccine and asked what will she do because after having the 2nd dose in April, patient is hearing ringing in her head and cannot sleep at night and wanted to know what to do. Comments/narrative: After receiving 2nd Dose of Pfizer vaccine ringing head started occurring. Have not been able to sleep at night since 2nd Dose, continual buzzing in head throughout the day.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Musculoskeletal stiffness, Nausea, Off label use, Pain
Clinical narrative: Flu-like systems; stiff; achy; feverish; nauseated; other vaccine same date product=Flu Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 38-year-old female patient received bnt162b2 (BNT162B2), administration date 21Oct2021 (Batch/Lot number: unknown) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm, administration date 21Oct2021 (Batch/Lot number: unknown). Relevant medical history included: "Endometriosis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR; GABAPENTIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 27Mar2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 17Apr2021, for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 22Oct2021, outcome "recovering", described as "Flu-like systems"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 22Oct2021, outcome "recovering", described as "stiff"; PAIN (non-serious) with onset 22Oct2021, outcome "recovering", described as "achy"; PYREXIA (non-serious) with onset 22Oct2021, outcome "recovering", described as "feverish"; NAUSEA (non-serious) with onset 22Oct2021, outcome "recovering", described as "nauseated"; OFF LABEL USE (non-serious) with onset 21Oct2021, outcome "unknown", described as "other vaccine same date product=Flu Vaccine". The action taken for influenza vaccine was unknown. Therapeutic measures were not taken as a result of influenza like illness, musculoskeletal stiffness, pain, pyrexia, nausea, off label use.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID since the vaccination.  Follow-up attempts completed. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Flu-like systems; stiff; achy; feverish; nauseated; other vaccine same date product=Flu Vaccine; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non-HCP).  A 38-year-old female patient received bnt162b2 (BNT162B2), administration date 21Oct2021 (Batch/Lot number: unknown) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (FLU), administered in arm, administration date 21Oct2021 (Batch/Lot number: unknown). Relevant medical history included: "Endometriosis" (unspecified if ongoing); "Asthma" (unspecified if ongoing). Concomitant medication(s) included: EFFEXOR; GABAPENTIN. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 27Mar2021, for COVID-19 immunization; Bnt162b2 (Dose Number: 2, Batch/Lot No: Unknown. Not available/provided to reporter at the time of report completion), administration date: 17Apr2021, for COVID-19 immunization. The following information was reported: INFLUENZA LIKE ILLNESS (non-serious) with onset 22Oct2021, outcome "recovering", described as "Flu-like systems"; MUSCULOSKELETAL STIFFNESS (non-serious) with onset 22Oct2021, outcome "recovering", described as "stiff"; PAIN (non-serious) with onset 22Oct2021, outcome "recovering", described as "achy"; PYREXIA (non-serious) with onset 22Oct2021, outcome "recovering", described as "feverish"; NAUSEA (non-serious) with onset 22Oct2021, outcome "recovering", described as "nauseated"; OFF LABEL USE (non-serious) with onset 21Oct2021, outcome "unknown", described as "other vaccine same date product=Flu Vaccine". The action taken for influenza vaccine was unknown. Therapeutic measures were not taken as a result of influenza like illness, musculoskeletal stiffness, pain, pyrexia, nausea, off label use.  Additional information: Patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Patient was not diagnosed with COVID-19 prior to vaccination and was not tested for COVID since the vaccination.  Follow-up attempts completed. No further information is expected.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Illness, Influenza like illness, Investigation
Clinical narrative: he vomited twice; nausea; diarrhea; Weakness was reported as worsened; has been sick ever since/He feels bad; He has flu like symptoms, but no temperature; 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 62 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 16Oct2021 09:30 (Lot number: FC3183) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: He has been taking medication for years. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Lot ED8448, expiration is unknown. This was injected on right arm in the muscle), administration date: 18Sep2021, for COVID-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset 17Oct2021, outcome "not recovered", described as "nausea"; DIARRHOEA (non-serious) with onset 17Oct2021, outcome "not recovered", described as "diarrhea"; ASTHENIA (non-serious) with onset 17Oct2021, outcome "not recovered", described as "Weakness was reported as worsened"; VOMITING (non-serious) with onset 18Oct2021, outcome "recovered" (19Oct2021), described as "he vomited twice"; ILLNESS (non-serious) with onset Oct2021, outcome "not recovered", described as "has been sick ever since/He feels bad"; INFLUENZA LIKE ILLNESS (non-serious) with onset Oct2021, outcome "unknown", described as "He has flu like symptoms, but no temperature". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported patient was feels bad. He wanted to know if this was normal. he stated he had lost every day that weak. He was weak, blah and cannot do anything. He provided his weight was between 150-155 lbs. He had been trying to eat and drink fluids and stay hydrated but was still weak. He was not one to get sick and never had the flu. Patient stated Nausea occurred at Evening, Diarrhea at morning, usually had it in the mornings lately. He had not eaten any spicy foods and was not drinking his coffee because it makes him nauseous. Patient experienced Weakness at Morning and Vomited at morning. Patient not administered additional Vaccines on Same Date of the Pfizer covid-19 vaccine. Patient had not taken other vaccinations within four weeks prior to the first administration date of the Pfizer covid-19 vaccine.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101430182 same reporter/product/event, different patient
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Nausea, Vomiting
Clinical narrative: he vomited twice; nausea; diarrhea; Weakness was reported as worsened; has been sick ever since/He feels bad; He has flu like symptoms, but no temperature; 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 62 year-old male patient received bnt162b2 (COMIRNATY), intramuscular, administered in arm right, administration date 16Oct2021 09:30 (Lot number: FC3183) at the age of 62 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing), notes: He has been taking medication for years. The patient took concomitant medications. Vaccination history included: Bnt162b2 (Dose:1, Lot ED8448, expiration is unknown. This was injected on right arm in the muscle), administration date: 18Sep2021, for COVID-19 immunisation. The following information was reported: NAUSEA (non-serious) with onset 17Oct2021, outcome "not recovered", described as "nausea"; DIARRHOEA (non-serious) with onset 17Oct2021, outcome "not recovered", described as "diarrhea"; ASTHENIA (non-serious) with onset 17Oct2021, outcome "not recovered", described as "Weakness was reported as worsened"; VOMITING (non-serious) with onset 18Oct2021, outcome "recovered" (19Oct2021), described as "he vomited twice"; ILLNESS (non-serious) with onset Oct2021, outcome "not recovered", described as "has been sick ever since/He feels bad"; INFLUENZA LIKE ILLNESS (non-serious) with onset Oct2021, outcome "unknown", described as "He has flu like symptoms, but no temperature". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: It was reported patient was feels bad. He wanted to know if this was normal. he stated he had lost every day that weak. He was weak, blah and cannot do anything. He provided his weight was between 150-155 lbs. He had been trying to eat and drink fluids and stay hydrated but was still weak. He was not one to get sick and never had the flu. Patient stated Nausea occurred at Evening, Diarrhea at morning, usually had it in the mornings lately. He had not eaten any spicy foods and was not drinking his coffee because it makes him nauseous. Patient experienced Weakness at Morning and Vomited at morning. Patient not administered additional Vaccines on Same Date of the Pfizer covid-19 vaccine. Patient had not taken other vaccinations within four weeks prior to the first administration date of the Pfizer covid-19 vaccine.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101430182 same reporter/product/event, different patient
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Body height, Muscular weakness
Clinical narrative: weakness in left arm; weakness in upper body strength; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 48 year-old male patient received bnt162b2 (COMIRNATY), administered in arm left, administration date 21Oct2021 (Batch/Lot number: unknown) at the age of 48 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "degeneration" (unspecified if ongoing), notes: Height changed from 6'1" to 5'11" prior to the vaccine due to degeneration. There were no concomitant medications. The following information was reported: MUSCULAR WEAKNESS (non-serious) with onset 21Oct2021, outcome "unknown", described as "weakness in left arm"; ASTHENIA (non-serious) with onset 21Oct2021, outcome "not recovered", described as "weakness in upper body strength". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of muscular weakness, asthenia.  Additional Information: It was reported that he had the vaccine and is having weakness in upper strength. Stated that his height changed from 6'1" to 5'11" prior to the vaccine due to degeneration.  Event details: Stated that it started in the left arm after the vaccine yesterday.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Headache, Nausea, Pain in extremity
Clinical narrative: severe arm pain for three days; fatigue; diarrhea for two days; headache; nauseous; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient received bnt162b2 (BNT162B2), administered in arm right, administration date 21Aug2021 (Lot number: fa7485) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Sensitive to gluten" (unspecified if ongoing); "covid" (unspecified if ongoing), notes: if covid prior vaccination: Yes. Concomitant medication(s) included: VITAMINS C; VITAMIN D [VITAMIN D NOS]; ZINC. The following information was reported: PAIN IN EXTREMITY (non-serious), outcome "recovered with sequelae", described as "severe arm pain for three days"; FATIGUE (non-serious), outcome "recovered with sequelae", described as "fatigue"; DIARRHOEA (non-serious), outcome "recovered with sequelae", described as "diarrhea for two days"; HEADACHE (non-serious), outcome "recovered with sequelae", described as "headache"; NAUSEA (non-serious), outcome "recovered with sequelae", described as "nauseous". The events "severe arm pain for three days", "fatigue", "diarrhea for two days", "headache" and "nauseous" were evaluated at the physician office visit. Therapeutic measures were not taken as a result of pain in extremity, fatigue, diarrhoea, headache, nausea.  No follow-up attempts are possible. No further information is expected.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Skin graft
Clinical narrative: This is a spontaneous report received from a contactable consumer or other non-HCP (patient). A 69-year-old patient received the 1st dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6200), at the age of 69, on Feb 14, 2021, single dose, and received the 2nd dose of BNT162B2 (Pfizer-BioNTech COVID-19 vaccine, batch/lot# EN6206), on Mar 10, 2021; both single dose, for COVID-19 immunisation. Medical history included type 2 diabetes (unspecified if ongoing); and cancer (unspecified if ongoing). The patient's concomitant medications not reported. The patient had pain in extremity (sore arm), fatigue/tiredness, onset 2021, with outcome of unknown; and skin graft (patient had a skin graft), onset Sep 19, 2021, with outcome of unknown. Skin graft evaluated at a physician office visit. Therapeutic measures were taken as a result of skin graft. Additional information: Therapeutic measures taken as a result of skin graft: antibiotic. No follow-up attempts possible. No further information expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Minor pain in injection site when pressed on; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 23 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 17May2021 09:30 (Lot number: EW0185) at the age of 22 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Anemia" (unspecified if ongoing). Concomitant medication(s) included: ALEVE. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: EW0170, Location of injection: Arm Left, Vaccine Administration Time: 09:30 AM), administration date: 19Apr2021, when the patient was 22 years old, for Covid-19 immunization.  The following information was reported: VACCINATION SITE PAIN (non-serious) with onset 21Oct2021 23:45, outcome "not recovered", described as "Minor pain in injection site when pressed on". Therapeutic measures were not taken as a result of vaccination site pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. Other medications in two weeks Aleve. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. No Known allergies.  No follow-up attempts are possible. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Toothache
Clinical narrative: Toothache; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP) from medical information team.  A 52 year-old male patient received bnt162b2 (COMIRNATY) (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single), for COVID-19 Immunization, reaction(s): "No adverse event". The following information was reported: TOOTHACHE (non-serious), outcome "unknown", described as "Toothache".  Additional Information: Caller's husband had a toothache before the booster shot, but in between the second dose and the booster shot.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Bedridden
Clinical narrative: Severe back pain; was unable to leave the bed for 2 days; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 30Sep2021 01:30 (Lot number: FC3182) at the age of 66 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Covid" (unspecified if ongoing). Concomitant medication(s) included: ROSUVASTATIN; AMLODIPINE. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9267, Location of injection: Arm Right, Vaccine Administration Time: 02:00 PM), administration date: 25Feb2021, when the patient was 65 years old, for Covid-19 Immunization, reaction(s): "No adverse effect"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL9265, Location of injection: Arm Right, Vaccine Administration Time: 02:30 AM), administration date: 29Jan2021, when the patient was 65 years old, for Covid-19 Immunization, reaction(s): "No adverse effect". The following information was reported: BACK PAIN (non-serious) with onset 01Oct2021 15:30, outcome "recovered with sequelae" (Oct2021), described as "Severe back pain"; BEDRIDDEN (non-serious) with onset 01Oct2021 15:30, outcome "recovered with sequelae" (Oct2021), described as "was unable to leave the bed for 2 days". Therapeutic measures were not taken as a result of back pain, bedridden.  Additional information: Pharmacy or drug store was the facility where the most recent COVID-19 vaccine was administered. The patient received Rosuvastin and Amlodipine medications within 2 weeks of vaccination. Prior to vaccination, the patient was diagnosed with COVID-19. Since the vaccination, the patient had not been tested for COVID-19. No known allergies. No other medical history reported. Device date: 22Oct2021. The next day after the 3rd shot, he had severe back pain and was unable to leave the bed for 2 days. He still had chronic back pain. He had no problems with the first 2 shots.  No follow-up attempts are possible. No further information is expected.
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Myalgia, Pain, Rash maculo-papular, Swelling
Clinical narrative: body aches; headaches; left deltoid soreness; left axillary swelling; developed a mild non-pruritic maculopapular rash to bilateral anterior flanks and under breast; This is a spontaneous report received from contactable reporter(s) (Other HCP). The reporter is the patient.  A 32 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 21Oct2021 11:30 (Lot number: FF2590) at the age of 32 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Well Controlled Asthma" (unspecified if ongoing); "Acne" (unspecified if ongoing). Concomitant medication(s) included: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE]; VIT D [COLECALCIFEROL]; VIT C. Vaccination history included: Bnt162b2 (Dose number 1, Lot number E19262, Dose administration time 7:00 PM), administration date: 29Jan2021, when the patient was 31 years old, for Covid-19 immunization; Bnt162b2 (Dose number 2, Lot number EM9809, Dose administration time 15:30 PM), administration date: 19Feb2021, when the patient was 31 years old, for Covid-19 immunization. The following information was reported: PAIN (non-serious) with onset 22Oct2021 19:30, outcome "unknown", described as "body aches"; HEADACHE (non-serious) with onset 22Oct2021 19:30, outcome "unknown", described as "headaches"; MYALGIA (non-serious) with onset 22Oct2021 19:30, outcome "unknown", described as "left deltoid soreness"; SWELLING (non-serious) with onset 22Oct2021 19:30, outcome "unknown", described as "left axillary swelling"; RASH MACULO-PAPULAR (non-serious) with onset 22Oct2021 19:30, outcome "unknown", described as "developed a mild non-pruritic maculopapular rash to bilateral anterior flanks and under breast". Therapeutic measures were not taken as a result of pain, headache, myalgia, swelling, rash maculo-papular.  Additional information: No other vaccine in four weeks. Other medications in two weeks: Prenatal Vitamin, Vit D, Vit C 1 tablet PO QD each. No covid prior vaccination. No covid tested post vaccination. No Known allergies. Adverse event included in addition to expected reactions including body aches, headaches, left deltoid sore-ness and left axillary swelling I also developed a mild non-pruritic maculopapular rash to bilateral ante-rior flanks and under breast. No treatment ae.  Follow-up attempts are completed. No further information is expected.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymph node pain, Lymphadenopathy, SARS-CoV-2 test
Clinical narrative: Headache; swollen lymph nodes in right underarm and right breast with pain; swollen lymph nodes in right underarm and right breast with pain; This is a spontaneous report received from contactable reporter(s) (Other HCP) Nurse. The reporter is the patient.  A 46-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 20Oct2021 13:00 (Lot number: FH8030) at the age of 46 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Allergy to Penicillin" (unspecified if ongoing); "Allergy to sulfa" (unspecified if ongoing). Concomitant medication(s) included: FLU VACCINE VII, administration date 21Sep2021. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9266, Location of injection: Arm Right, Vaccine Administration Time: 12:00), administration date: 16Feb2021, when the patient was 45 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL3249, Location of injection: Arm Right, Vaccine Administration Time: 12:00), administration date: 26Jan2021, when the patient was 45 years old, for Covid-19 Immunization. The following information was reported: HEADACHE (non-serious) with onset 22Oct2021 17:00, outcome "unknown", described as "Headache"; LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 22Oct2021 17:00, outcome "unknown" and all described as "swollen lymph nodes in right underarm and right breast with pain". The events "headache", "swollen lymph nodes in right underarm and right breast with pain" and "swollen lymph nodes in right underarm and right breast with pain" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. It was unknown if therapeutic measures were taken as a result of headache, lymphadenopathy, lymph node pain.  Additional information: if covid prior vaccination No. if covid tested post vaccination was yes  No follow-up attempts are possible. No further information is expected.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness
Clinical narrative: Dizziness; weakness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 14:30 (Lot number: FF2589) at the age of 57 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "Diabetics" (unspecified if ongoing). Concomitant medication(s) included: JARDIAN; LANTUS; VITAMIN C ACID; JANUVIA. Past drug history included: Sulfa, reaction(s): "Allergy"; Keflex, reaction(s): "Allergy". The following information was reported: DIZZINESS (non-serious) with onset 22Oct2021 17:00, outcome "recovered" (Oct2021), described as "Dizziness"; ASTHENIA (non-serious) with onset 22Oct2021 17:00, outcome "recovered" (Oct2021), described as "weakness". Therapeutic measures were not taken as a result of dizziness, asthenia.  Additional information: Facility where the most recent COVID-19 vaccine was administered was reported as military base. The patient was not received any other vaccines within 4 weeks prior to the COVID vaccine. List of any other medications the patient received within 2 weeks of vaccination were Jardian, januvia, lantus 10 units, vitamin C. Prior to vaccination, was the patient diagnosed with COVID-19 was reported as unknown. Since the vaccination, the patient was not tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Slightly sore arm the first day; This is a spontaneous report received from contactable reporter(s) (Consumer or other non-HCP). The reporter is the patient.  A 71-year-old male patient received bnt162b2 (BNT162B2), administered in arm left, administration date 22Oct2021 13:30 (Lot number: FE3590) at the age of 71 years as dose 3 (booster), single for covid-19 immunisation; influenza vaccine (INFLUENZA), administered in arm right, administration date 22Oct2021 (Batch/Lot number: unknown) for immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE: 2, Batch/Lot No: EN8732, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 29Mar2021, when the patient was 70 years old, for COVID-19 Immunization; Bnt162b2 (DOSE: 1, Batch/Lot No: EN6203, Location of injection: Arm Left, Vaccine Administration Time: 10:00 AM), administration date: 08Mar2021, when the patient was 70 years old, for COVID-19 Immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 22Oct2021, outcome "recovered" (Oct2021), described as "Slightly sore arm the first day". Therapeutic measures were not taken as a result of pain in extremity.  Additional information: Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Insomnia
Clinical narrative: Severe insomnia only able to sleep 2 - 3 hours and wake and remain awake. Had severe insomnia after other shots but didn't connect it to vaccine at that time. Insomnia waned over the summer; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 62 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 19Oct2021 11:15 (Lot number: 30155BA) at the age of 62 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "high blood pressure" (unspecified if ongoing); "coconut, onions" (unspecified if ongoing); "known allergy-Sulfa" (unspecified if ongoing); "if covid prior vaccination: Yes" (unspecified if ongoing). The patient took concomitant medications. Past drug history included: Ibupropfin, reaction(s): "Known allergy-Ibuprofin". Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EP7534, Location of injection: Arm Left), administration date: 18Mar2021, when the patient was 62 years old, for Covid-19 Immunization; Bnt162b2 (Dose Number: 1, Batch/Lot No: EN6203, Location of injection: Arm Left), administration date: 25Feb2021, when the patient was 62 years old, for Covid-19 Immunization. The following information was reported: INSOMNIA (non-serious) with onset 20Oct2021 12:00, outcome "unknown", described as "Severe insomnia only able to sleep 2 - 3 hours and wake and remain awake. Had severe insomnia after other shots but didn't connect it to vaccine at that time. Insomnia waned over the summer". Therapeutic measures were not taken as a result of insomnia.  Additional information: The most recent COVID-19 vaccine was administered at public Health Clinic/ facility. The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine. The patient received other medications within 2 weeks of vaccination included prescription for blood pressure. Reported Event: Severe insomnia only able to sleep 2 - 3 hours and wake and remain awake. Had severe insomnia after other shots but didn't connect it to vaccine at that time. Insomnia waned over the summer. Started the night after patient received 3rd dose. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 31.0
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Menstruation irregular
Clinical narrative: Menstruating one week early with changes in flow; Menstruating one week early with changes in flow; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 31-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 07Oct2021 17:30 (Lot number: FF8839) at the age of 31 years as dose 2, single for covid-19 immunisation. The patient had no relevant medical history. Concomitant medication(s) included: FLUOXETINE. Vaccination history included: Bnt162b2 (Dose 1, Single, Lot number: FF8839, Dose administration time: 17:30 PM, Dose vaccine location: Left arm), administration date: 16Sep2021, when the patient was 31 years old, for Covid-19 immunisation. The following information was reported: MENSTRUATION IRREGULAR (non-serious), MENSTRUAL DISORDER (non-serious) all with onset 18Oct2021 11:00, outcome "unknown" and all described as "Menstruating one week early with changes in flow". Therapeutic measures were not taken as a result of menstruation irregular, menstrual disorder.  Additional information: No other vaccine in four weeks. No covid prior vaccination. No known allergies. Facility type vaccine was pharmacy or drug store. No covid tested post vaccination. Serious was no.  Follow-up attempts are completed. No further information is expected.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: 2nd shot and booster I had swelling of lymph nodes size of a lemon very sore. Swelling lasted about seven days.; 2nd shot and booster I had swelling of lymph nodes size of a lemon very sore. Swelling lasted about seven days.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm right, administration date 25Mar2021 12:00 (Lot number: En6199) as dose 2, single and administered in arm left, administration date 20Oct2021 13:00 (Lot number: Ff8839) as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Have an ileostomy" (unspecified if ongoing), notes: Have an ileostomy; "Known allergies: penicillin" (unspecified if ongoing), notes: Known allergies: penicillin; "Known allergies :eggs" (unspecified if ongoing), notes: Known allergies: eggs. The patient's concomitant medications were not reported. Past drug history included: Morphine, reaction(s): "Known allergies: Morphine", notes: Known allergies: Morphine; Sulphuric, reaction(s): "Known allergies: Sulphuric", notes: Known allergies: Sulphuric. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: En6200, Location of injection: Arm Right, No event reported), administration date: 03Mar2021, when the patient was 77 years old, for COVID-19 immunization. The following information was reported: LYMPHADENOPATHY (non-serious), LYMPH NODE PAIN (non-serious) all with onset 2021, outcome "recovered" (2021) and all described as "2nd shot and booster I had swelling of lymph nodes size of a lemon very sore. Swelling lasted about seven days.". Therapeutic measures were not taken as a result of lymphadenopathy, lymph node pain.   Additional information: The patient did not receive any other vaccines within 4 weeks prior to the COVID vaccine.  2nd shot and booster I had swelling of lymph nodes size of a lemon very sore. Swelling lasted about seven days. Date of start of reaction/event: 21Oct2021. Prior to vaccination, the patient did not diagnosed with COVID-19.Since the vaccination, the patient has not been tested for COVID-19. Outcome of reaction/event at the time of last observation: Recovering/Resolving as reported. Hospitalization Prolonged: No  No follow-up attempts are possible. No further information is expected.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Investigation, Movement disorder, Muscle disorder, Pain in extremity
Clinical narrative: Worsening pain in arm; specific muscles not working; Can't move arm in a certain direction; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP).  A 49 year-old male patient received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Oct2021 (Lot number: FF8839) at the age of 49 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "Grass allergy" (unspecified if ongoing). Concomitant medication(s) included: FLU, administration date 15Sep2021. Vaccination history included: Bnt162b2 (DOSE: 2, Batch/Lot No: ER8737, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: 31Mar2021, when the patient was 49 years old, for COVID-19 immunization; Bnt162b2 (DOSE: 1, Batch/Lot No: EN6207, Location of injection: Arm Left, Route of Administration: Intramuscular), administration date: Mar2021, when the patient was 49 years old, for COVID-19 immunization. The following information was reported: PAIN IN EXTREMITY (non-serious) with onset 11Oct2021, outcome "not recovered", described as "Worsening pain in arm"; MUSCLE DISORDER (non-serious) with onset 11Oct2021, outcome "not recovered", described as "specific muscles not working"; MOVEMENT DISORDER (non-serious) with onset 11Oct2021, outcome "not recovered", described as "Can't move arm in a certain direction". The events "worsening pain in arm", "specific muscles not working" and "can't move arm in a certain direction" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pain in extremity, muscle disorder, movement disorder.  Additional information: Serious- No, events did not resulted in death, Life threatening, Caused/prolonged hospitalization, Disabling/Incapacitating and Congenital anomaly/birth defect - No. Facility where the most recent COVID-19 vaccine was administered: Pharmacy or Drug Store. Other vaccine 4 weeks product: Flu, date= 15Sep2021. Reported Event: Worsening pain in arm and specific muscles not working. Can't move arm in a certain direction. Adverse event start date: 11Oct2021, ae resulted in: Doctor or other healthcare professional office/clinic visit, if patient recovered: Not recovered, if treatment ae: Yes, ae treatment: naproxen, tests still in progress. Prior to vaccination, patient was not diagnosed with COVID-19. Since the vaccination, patient has not been tested for COVID-19.  No follow-up attempts are possible. No further information is expected.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Asymmetric di-methylarginine increased, Blood test, Blood test abnormal, Endothelial dysfunction, Metabolic function test
Clinical narrative: I was tested again as a comprehensive test and my ADMA levels had increased along with some other abnormal blood tests; I was tested again as a comprehensive test and my ADMA levels had increased along with some other abnormal blood tests; My results showed Endothelial damage that occurred within 4 months; 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), administered in arm right, administration date 26Apr2021 (Lot number: Er8736) at the age of 33 years as dose 1, single and administered in arm left, administration date 17May2021 09:00 (Lot number: Ew0177) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: ASYMMETRIC DI-METHYLARGININE INCREASED (non-serious), BLOOD TEST ABNORMAL (non-serious) all with onset 2021, outcome "not recovered" and all described as "I was tested again as a comprehensive test and my ADMA levels had increased along with some other abnormal blood tests"; ENDOTHELIAL DYSFUNCTION (non-serious) with onset 2021, outcome "unknown", described as "My results showed Endothelial damage that occurred within 4 months". The events "i was tested again as a comprehensive test and my adma levels had increased along with some other abnormal blood tests", "i was tested again as a comprehensive test and my adma levels had increased along with some other abnormal blood tests" and "my results showed endothelial damage that occurred within 4 months" were evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of asymmetric di-methylarginine increased, blood test abnormal, endothelial dysfunction.  Additional Information: Prior to vaccination, was the patient diagnosed with COVID-19 was reported as no. Since the vaccination, has the patient been tested for COVID-19 was reported as no. Known allergies was reported as no. Other medical history was reported as No. Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine was reported as no. Reported Event: patient had Endothelial vessels tested in Mar2021 and they were fine. After receiving the vaccine, patient was tested again as a comprehensive test and patient ADMA levels had increased along with some other abnormal blood tests. patient results showed Endothelial damage that occurred within 4 months. The only thing patient did was got vaccinated. Did the adverse event result in any of the following was reported as Doctor or other healthcare professional office, clinic visit. No follow-up attempts are possible. No further information is expected.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Hypoaesthesia, Paraesthesia
Clinical narrative: Extremely week; tired; numbness and tingling in both legs and hands; numbness and tingling in both legs and hands; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 68 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 03Oct2021 11:00 (Lot number: FF8841) at the age of 68 years as dose 2, 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: 1, Vaccine Administration Time: 12:00, Batch/Lot No: Lot # FC3184, Location of injection: Arm Left), administration date: 12Sep2021, when the patient was 68 years old, for COVID-19 Immunization. The following information was reported: ASTHENIA (non-serious) with onset 04Oct2021 11:00, outcome "not recovered", described as "Extremely week"; FATIGUE (non-serious) with onset 04Oct2021 11:00, outcome "not recovered", described as "tired"; HYPOAESTHESIA (non-serious), PARAESTHESIA (non-serious) all with onset 04Oct2021 11:00, outcome "not recovered" and all described as "numbness and tingling in both legs and hands". Therapeutic measures were not taken as a result of asthenia, fatigue, hypoaesthesia, paraesthesia.  Additional information: Did the patient receive any other vaccines within 4 weeks prior to the COVID vaccine: No. List of any other medications the patient received within 2 weeks of vaccination: No. The event had not resulted in for death, life-threatening, prolonged hospitalisation, disabling/incapacitating or Congenital anomaly/birth defect. Adverse event Extremely week and tired, numbness and tingling in both legs and hands. Started after second dose and continued. if patient recovered: Not recovered. If treatment ae: No. Prior to vaccination, was the patient diagnosed with COVID-19: No. Since the vaccination, has the patient been tested for COVID-19: No.  No follow-up attempts are possible. No further information is expected.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Headache, Hypoaesthesia, Peripheral coldness
Clinical narrative: Rash all over body; cold hands and feet; numb toes for 8 hours; violent shivering; headache; all body heat went to head and chest; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 22 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 19Oct2021 16:45 (Batch/Lot number: unknown) at the age of 22 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "bee stings" (unspecified if ongoing), notes: bee sting; "pineapple" (unspecified if ongoing), notes: pineapple. There were no concomitant medications. Past drug history included: Tramadol, reaction(s): "known allergies: tramadol"; Sassafras, reaction(s): "known allergies: sassafras", notes: sassafras. Vaccination history included: Bnt162b2 (Dose Number: 1, Batch/Lot No: Unknown. Unable to locate or read the details, Location of injection: Arm Left, Vaccine Administration Time: 05:00 PM), administration date: 28Sep2021, when the patient was 22 years old, for COVID-19 Immunization. The following information was reported: RASH (non-serious) with onset 19Oct2021 20:45, outcome "not recovered", described as "Rash all over body"; PERIPHERAL COLDNESS (non-serious) with onset 19Oct2021 20:45, outcome "not recovered", described as "cold hands and feet"; HYPOAESTHESIA (non-serious) with onset 19Oct2021 20:45, outcome "recovered" (20Oct2021), described as "numb toes for 8 hours"; CHILLS (non-serious) with onset 19Oct2021 20:45, outcome "not recovered", described as "violent shivering"; HEADACHE (non-serious) with onset 19Oct2021 20:45, outcome "not recovered", described as "headache"; FEELING HOT (non-serious) with onset 19Oct2021 20:45, outcome "not recovered", described as "all body heat went to head and chest". Therapeutic measures were not taken as a result of rash, peripheral coldness, hypoaesthesia, chills, headache, feeling hot.  Reported Event: Rash all over body (had it since 4 hours after vaccination), cold hands and feet, numb toes for 8 hours, violent shivering, headache, all body heat went to head and chest. 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. Prior to vaccination, the patient was not diagnosed with COVID-19. Since the vaccination, the patient has not been tested for COVID-19. Device Date: 24Oct2021.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.