chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 25.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose, Body temperature, Pyrexia
Clinical narrative: running a temperature; 1.5 mL booster administered; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (running a temperature) and ACCIDENTAL OVERDOSE (1.5 mL booster administered) in a 25-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 06AH21A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1.5 milliliter. On 10-Jan-2022, the patient experienced ACCIDENTAL OVERDOSE (1.5 mL booster administered). On an unknown date, the patient experienced PYREXIA (running a temperature). On 10-Jan-2022, ACCIDENTAL OVERDOSE (1.5 mL booster administered) had resolved. At the time of the report, PYREXIA (running a temperature) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, Body temperature: high (High) Running a temperature.         No concomitant medications were reported No treatment medications were reported
Sex: F
Vaccine: COVID19
Symptoms: Sensation of blood flow
Clinical narrative: The blood has now gone to her breast.; This spontaneous case was reported by a consumer and describes the occurrence of SENSATION OF BLOOD FLOW (The blood has now gone to her breast.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SENSATION OF BLOOD FLOW (The blood has now gone to her breast.). At the time of the report, SENSATION OF BLOOD FLOW (The blood has now gone to her breast.) outcome was unknown.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant products and treatment information were reported. It was reported that the same arm that she received the first shot in, she stated it appears the blood has now gone to her breast.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: was sick with my 2 vaccines; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (was sick with my 2 vaccines) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ILLNESS (was sick with my 2 vaccines). At the time of the report, ILLNESS (was sick with my 2 vaccines) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided.  Patient was sick with two vaccines. Patient received booster on 11 Jan 2022.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pruritus
Clinical narrative: Itchy skin; Fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of PRURITUS (Itchy skin) and FATIGUE (Fatigue) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itchy skin) and FATIGUE (Fatigue). At the time of the report, PRURITUS (Itchy skin) and FATIGUE (Fatigue) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported. Patient states is it Itchy skin and fatigue symptom of booster shot?   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: A patient was inadvertently given more than was recommended; This spontaneous case was reported by a nurse and describes the occurrence of ACCIDENTAL OVERDOSE (A patient was inadvertently given more than was recommended) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (A patient was inadvertently given more than was recommended). At the time of the report, ACCIDENTAL OVERDOSE (A patient was inadvertently given more than was recommended) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment medications were provided
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate irregular, Palpitations, Pollakiuria
Clinical narrative: heart racing & erratic; heart racing & erratic; urinated 7 times in 1 hour; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administration date 06Feb2021 (Lot number: EL9261, Expiration Date: 31May2021) at the age of 76 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Pituitary Addinson's Disease", start date: Sep2016 (ongoing); "Stercotactic Radiosurgery at Emory of Pituitary Tumor", start date: 14May2015, stop date: 14May2015, notes: for Pituitary Addinson's Disease; "Heart Bypass surgery", start date: 08Dec2009, stop date: 08Dec2009; "blood pressure increased" (ongoing). Concomitant medication(s) included: ATENOLOL taken for blood pressure increased, start date: 1995 (ongoing); AMLODIPINE taken for blood pressure increased, start date: 1994 (ongoing); LEVOTHYROXINE, start date: 2016 (ongoing); HYDROCORTISONE, start date: 2016 (ongoing); ZYRTEC [CETIRIZINE HYDROCHLORIDE] (ongoing); FISH OIL (ongoing); VITAMIN C [ASCORBIC ACID] (ongoing); VITAMIN D [COLECALCIFEROL] (ongoing); CALCIUM (ongoing); ASPIRIN [ACETYLSALICYLIC ACID;ASCORBIC ACID] (ongoing); MAGNESIUM (ongoing); MIRALAX (ongoing); METAMUCIL [PLANTAGO OVATA] (ongoing). Vaccination history included: Bnt162b2 (Dose: 1, Lot Number: EL1283 , EXP 30Apr2021, Anatomical Location: Arm Left), administration date: 16Jan2021, when the patient was 76 years old, for Covid-19 Immunisation, reaction(s): "heart racing and erratic", "urinated 9 times in the next hour". The following information was reported: PALPITATIONS (non-serious), HEART RATE IRREGULAR (non-serious) all with onset 13Feb2021 07:00, outcome "unknown" and all described as "heart racing & erratic"; POLLAKIURIA (non-serious) with onset 13Feb2021 07:00, outcome "unknown", described as "urinated 7 times in 1 hour".  Additional Information: The patient was vaccinated in a hospital. The patient also took multivitamin as a concomitant therapy. Events did not result to doctor or other healthcare professional office/clinic and emergency room visit. It was also reported that the patient took antipyretic 3 days before the second dose.  No follow-up attempts are possible. No further information is expected.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: uncontrollable diarrhea; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A 79 year-old male patient received bnt162b2 (BNT162B2), administration date 19Aug2021 (Lot number: FA7485) at the age of 79 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "type 2 diabetic" (unspecified if ongoing). Concomitant medication(s) included: JARDIANCE taken for type 2 diabetes mellitus, start date: 16Aug2021 (ongoing). The following information was reported: DIARRHOEA (non-serious) with onset 20Aug2021, outcome "not recovered", described as "uncontrollable diarrhea". Additional information: The reporter reported for her husband. The patient had injection on 19Aug2021, and her husband had experienced uncontrollable diarrhea in morning on 20Aug2021, he didn't realize it was happening and there was no indication for it. This was unusual for him.  No follow-up attempts are possible. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).   A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single and (Batch/Lot number: unknown) as dose 2, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: TINNITUS (non-serious), outcome "unknown", described as "Tinnitus".  Additional Information: The reporter has issues on tinnitus and it was reported that the patient had the same issue after both Pfizer shots.  The lot number for bnt162b2 was not provided and will be requested during follow up.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202101097446 same reporter, patient, product, drug/AE, different patients
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Lymphadenopathy (LAN) under left axilla + left breast mild; This is a spontaneous report received from a contactable reporter(s) (Other HCP). The reporter is the patient.  A 49 year-old female patient received bnt162b2 (BNT162B2), intramuscular, administered in deltoid left, administration date 30Dec2020 (Lot number: EJ1685) at the age of 49 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "GERD" (unspecified if ongoing). Concomitant medication(s) included: PREVACID taken for gastrooesophageal reflux disease (ongoing). The following information was reported: LYMPHADENOPATHY (non-serious), outcome "not recovered", described as "Lymphadenopathy (LAN) under left axilla + left breast mild". Additional information: Event happened after the first dose. The patient had no prior vaccinations and no relevant tests.  No follow-up attempts are possible. No further information is expected.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Neuralgia, Small fibre neuropathy
Clinical narrative: small fiber neuropathy; severe nerve pain; Muscle pain; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72 year-old female patient received bnt162b2 (BNT162B2), administered in arm left, administration date 02Feb2021 10:00 (Lot number: EL9264) at the age of 72 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "Cholesterol" (unspecified if ongoing), notes: diagnosed about 15 years ago; "Nerve pain" (unspecified if ongoing); "Blood pressure" (unspecified if ongoing); "extreme pain" (unspecified if ongoing). Concomitant medication(s) included: GABAPENTIN taken for neuralgia, start date: Oct2020; TRAMADOL taken for analgesic therapy; ATORVASTATIN taken for blood cholesterol; LOSARTAN taken for blood pressure measurement. Vaccination history included: Bnt162b2 (First dose: 11Jan2021, around 10 am, Lot: EL3249, Expiry: unknown, Anatomical location : injection in left arm), administration date: 11Jan2021, when the patient was 72 years old, for COVID-19 immunization. The following information was reported: NEURALGIA (non-serious) with onset Feb2021, outcome "not recovered", described as "severe nerve pain"; MYALGIA (non-serious) with onset Feb2021, outcome "not recovered", described as "Muscle pain"; SMALL FIBRE NEUROPATHY (non-serious), outcome "unknown", described as "small fiber neuropathy". No follow-up attempts are possible. No further information is expected Addition information : It was reported that patient had a reaction to the second Pfizer covid shot. Patient had such severe nerve pain and muscle pain since Feb2021. Patient would like to be able to take the booster and was afraid. Shortly thereafter Patient was diagnosed with small fiber neuropathy and does not know if it was a result of the vaccine. Nerve and muscle pain was severely exacerbated the night after the second dose and thereafter and progressively getting worse. The report was not related to a study or programme. No Investigation Assessment was done. Patient was having Other Products. Patient was taking Tramadol for a year, Atorvastatin for many years, or 15 years. Patient was not been on the same dose the whole time, Losartan for about 2 years, taking 100mg less than 2 years and Gabapentin 100mg capsule to dose, clarifies that patient was taking 300mg three times a day and now takes 400mg three times a day (300mg + 100mg three times a day). Patient was trying to figure out what is going to help pain but so far nothing is. It was not the medication that is causing. Patient had medications, and had a flu vaccine last week. Vaccination Facility Type was Hospital. Additional Vaccines Administered on Same Date of the Pfizer Suspect was none. No Emergency Room, Physician Office (maybe spoke to hcp). Prior Vaccinations (within 4 weeks) was none and adverse events following prior vaccinations was None. There was product complaint. No Family Medical History Relevant to adverse events. None Relevant Tests were performed.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site bruising, Vaccination site haemorrhage
Clinical narrative: bruise at injection site; Bleeding at injection site; sore arm; This is a spontaneous report received from contactable reporter (Consumer or other non HCP).  A 10-year-old female patient (not pregnant) received bnt162b2 (BNT162B2), intramuscular, administered in arm left, administration date 05Nov2021 (Lot number: FK5127) at the age of 10 years as DOSE 1 (TRIS), SINGLE for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: VACCINATION SITE HAEMORRHAGE (non-serious) with onset 05Nov2021 15:00, outcome "recovered" (Nov2021), described as "Bleeding at injection site"; PAIN IN EXTREMITY (non-serious) with onset 05Nov2021, outcome "recovered" (Nov2021), described as "sore arm"; VACCINATION SITE BRUISING (non-serious) with onset 06Nov2021, outcome "recovered" (07Nov2021), described as "bruise at injection site". Therapeutic measures were not taken as a result of vaccination site haemorrhage, pain in extremity, vaccination site bruising. No follow-up attempts are possible. No further information is expected.
Age: 8.0
Sex: M
Vaccine: COVID19
Symptoms: Product leakage, Underdose
Clinical narrative: He received 50% of the vaccine.; 50% of the vaccine had leaked out during administration; This is a spontaneous report received from a contactable reporter (Pharmacist) from medical information team for a Pfizer sponsored program (159558).  An 8-year-old male patient received bnt162b2 (COMIRNATY), administration date 08Nov2021 (Batch/Lot number: unknown) at the age of 8 years as dose number unknown, single for COVID-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: UNDERDOSE (non-serious) with onset 08Nov2021, outcome "unknown", described as "He received 50% of the vaccine."; PRODUCT LEAKAGE (non-serious) with onset 08Nov2021, outcome "unknown", described as "50% of the vaccine had leaked out during administration". Additional information: The pharmacist was inquiring about an invalid pediatric dose which was administered on 08Nov2021 to an 8-year-old patient. The patient received 50% of the vaccine. The pharmacist declared that 50% of the vaccine had leaked out during administration.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Hypersensitivity, Nasopharyngitis
Clinical narrative: Had a cold/allergies for two weeks; Had a cold/allergies for two weeks; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). Other Case identifier(s): US-PFIZER INC-202101627441 (Pfizer).  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NASOPHARYNGITIS (non-serious), HYPERSENSITIVITY (non-serious) all with onset 19Nov2021, outcome "unknown" and all described as "Had a cold/allergies for two weeks".  Additional information: One of the hosts said had a cold/allergies for two weeks, that they were unsure which one. They did not have a sore throat or fever, and sneezed at least once on the show. The other host is a hypochondriac and also thought was getting sick. Likely both individuals are vaccinated. The show released 24Jun2021. Individual has gone through approximately 75 tissues in 37 mins of episode. Approximately one full 65 tissues tissue box plus around 10 more tissues. Had listened to podcast yesterday, but did not hear this.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: M
Vaccine: COVID19
Symptoms: Platelet count, Platelet count decreased
Clinical narrative: Low platelet count; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP).  A male patient received bnt162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE), administration date 2021 (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: PLATELET COUNT DECREASED (medically significant) with onset 2021, outcome "not recovered", described as "Low platelet count". The patient underwent the following laboratory tests and procedures: platelet count: (2021) low; (2021) 15; (2021) 40, notes: now he is up to 40 but it is supposed to be 150,000. Therapeutic measures were taken as a result of platelet count decreased. Clinical course is as follows: The patient had the Pfizer covid vaccine and had the reaction of a low platelet count and it is 7-8 months and he still has the low platelet count; it was reported that they tried different things to try to boost the platelet count, the reporter has no names of things they tried to boost the platelet count and no dosages, medication names, lot numbers or further information to provide other than she knows he had some kind of drip where he had to go once per week for four weeks and that ended 3-4 weeks ago and the lowest point of his platelets was 15 and now he is up to 40 but it is supposed to be 150,000. The reporter has no lots, expiry dates or NDC numbers to provide for the patient's Pfizer Covid Vaccine.  The lot/batch number is not available despite the follow-up attempts made. Follow-up attempts completed. No further information is expected.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain
Clinical narrative: headache; soreness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) for a Pfizer sponsored program.  A 81 year-old patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: TIKOSYN. The following information was reported: HEADACHE (non-serious), outcome "unknown", described as "headache"; PAIN (non-serious), outcome "unknown", described as "soreness".  Additional Information: Patient called regarding Tikosyn 0.125mg assistance again. During call patient explained She went off of Tikosyn she had some problems she had an ablation and all this and she called to see if Tikosyn is still available. Patient reported When she had some problems she was taken off the Tikosyn and put back on Pradaxa and at the time the doctor wanted her to go back on Tikosyn and when she called Tiksoyn was not available so she had to go back on Pradaxa . Later on call patient shared how got Pfizer vaccine and she really didn't have any side effects to speak of except a headache and maybe just soreness a little bit all over but she got over that. Date the event description was reported was 03Dec2021  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: Feeling cold, Headache, Pain, Pain in extremity, Skin warm
Clinical narrative: shaking; freezing; My skin was very hot; body ached/ Head, arm, body aches; Head, arm, body aches; Head, arm, body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 09:45 (Lot number: 331308A) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Tree nuts" (unspecified if ongoing), notes: Known allergy: Tree nuts. Concomitant medication(s) included: ZOLOFT; VITAMIN D3; VITAMIN B6; ASPIRIN (E.C.). The following information was reported: TREMOR (non-serious) with onset 16Dec2021 02:30, outcome "recovering", described as "shaking"; FEELING COLD (non-serious) with onset 16Dec2021 02:30, outcome "recovering", described as "freezing"; SKIN WARM (non-serious) with onset 16Dec2021 02:30, outcome "recovering", described as "My skin was very hot"; PAIN (non-serious) with onset 16Dec2021 02:30, outcome "recovering", described as "body ached/ Head, arm, body aches"; HEADACHE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 16Dec2021 02:30, outcome "recovering" and all described as "Head, arm, body aches". Therapeutic measures were not taken as a result of tremor, feeling cold, skin warm, pain, headache, pain in extremity.  Additional information: No other vaccine in four weeks.  No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Tremor
Clinical narrative: shaking; freezing; My skin was very hot; body ached/ Head, arm, body aches; Head, arm, body aches; Head, arm, body aches; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 55 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 15Dec2021 09:45 (Lot number: 331308A) at the age of 55 years as dose 1, single for covid-19 immunisation. Relevant medical history included: "High blood pressure" (unspecified if ongoing); "Tree nuts" (unspecified if ongoing), notes: Known allergy: Tree nuts. Concomitant medication(s) included: ZOLOFT; VITAMIN D3; VITAMIN B6; ASPIRIN (E.C.). The following information was reported: TREMOR (non-serious) with onset 16Dec2021 02:30, outcome "recovering", described as "shaking"; FEELING COLD (non-serious) with onset 16Dec2021 02:30, outcome "recovering", described as "freezing"; SKIN WARM (non-serious) with onset 16Dec2021 02:30, outcome "recovering", described as "My skin was very hot"; PAIN (non-serious) with onset 16Dec2021 02:30, outcome "recovering", described as "body ached/ Head, arm, body aches"; HEADACHE (non-serious), PAIN IN EXTREMITY (non-serious) all with onset 16Dec2021 02:30, outcome "recovering" and all described as "Head, arm, body aches". Therapeutic measures were not taken as a result of tremor, feeling cold, skin warm, pain, headache, pain in extremity.  Additional information: No other vaccine in four weeks.  No covid prior vaccination. No covid tested post vaccination.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Influenza
Clinical narrative: now she has flu symptoms/I have the flu now I don't know its flu or not; 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 65 year-old female patient received bnt162b2 (BNT162B2), administration date 03Dec2021 (Batch/Lot number: unknown) as dose 1 , single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INFLUENZA (non-serious) with onset Dec2021, outcome "unknown", described as "now she has flu symptoms/I have the flu now I don't know its flu or not". No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Oropharyngeal pain
Clinical narrative: Throat is hurting; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 11 year-old female patient received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose number unknown, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: OROPHARYNGEAL PAIN (non-serious), outcome "unknown", described as "Throat is hurting". Therapeutic measures were taken as a result of oropharyngeal pain.  Additional information: Reporter stated, reporters daughter got the Pfizer, she was 11 years old So, that's the only part that's hurting it was her throat so I gave her some Ibuprofen (Treatment)." When probed to repeat the concern: Reporter stated, "That his daughter got the Pfizer vaccine and she was complaining of her throat." When probed if have a question regarding it or want to report: Reporter stated, reporter just want to know what he can do about it.  The lot number for bnt162b2 was not provided and will be requested during follow up.
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Breast pain
Clinical narrative: 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 59 year-old female patient received bnt162b2 (BNT162B2), administration date Apr2021 (Batch/Lot number: unknown) as dose 2, single and administration date Apr2021 (Batch/Lot number: unknown) as dose 1, single for covid-19 immunisation. Relevant medical history included: "myocarditis" (unspecified if ongoing), notes: I was worried I had myocarditis. The patient's concomitant medications were not reported. The following information was reported: BREAST PAIN (non-serious) with onset Apr2021, outcome "not recovered", described as "My left breast hurts, it hurts more with inhalation". The event "my left breast hurts, it hurts more with inhalation" was evaluated at the physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Additional information: The patient reported that the doctors rule out a PE and did a d dimer and sent her home because it was normal. After 2nd dose she states the same side effects that lasted longer and were more painful and did not go to ER. Both 1st and 2nd shots in April and was nervous about getting her booster dose.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: Decreased appetite, Dizziness, Fatigue, Immunisation, Interchange of vaccine products
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 11:30 (Lot number: Fl3197) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "IgA nephropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 026b21a, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 13Apr2021, for Covid-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 008c21a, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 11May2021, for COVID-19 immunization.The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 18Dec2021 11:30, outcome "unknown", described as "Dose 1: Moderna; Dose 2: Moderna"; IMMUNISATION (non-serious) with onset 18Dec2021 11:30, outcome "unknown", described as "Booster"; MIGRAINE (non-serious) with onset 19Dec2021 08:00, outcome "recovering", described as "Migraine"; LYMPHADENOPATHY (non-serious) with onset 19Dec2021 08:00, outcome "recovering", described as "Swollen lymph node in underarm"; FATIGUE (non-serious) with onset 19Dec2021 08:00, outcome "recovering", described as "Extreme fatigue"; DIZZINESS (non-serious) with onset 19Dec2021 08:00, outcome "recovering", described as "Light headedness"; NAUSEA (non-serious) with onset 19Dec2021 08:00, outcome "recovering", described as "Nausea"; DECREASED APPETITE (non-serious) with onset 19Dec2021 08:00, outcome "recovering", described as "Loss of appetite". Therapeutic measures were not taken as a result of migraine, lymphadenopathy, fatigue, dizziness, nausea, decreased appetite.Additional Information:Prior vaccination within 4 weeks was reported as none. Prior vaccination patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.No follow-up attempts are possible. No further information is expected.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Migraine, Nausea
Clinical narrative: This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient. A 38 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 18Dec2021 11:30 (Lot number: Fl3197) at the age of 38 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "IgA nephropathy" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Moderna (Dose Number: 2, Batch/Lot No: 026b21a, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 13Apr2021, for Covid-19 immunization; Moderna (Dose Number: 1, Batch/Lot No: 008c21a, Location of injection: Arm Left, Vaccine Administration Time: 02:00 PM), administration date: 11May2021, for COVID-19 immunization.The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 18Dec2021 11:30, outcome "unknown", described as "Dose 1: Moderna; Dose 2: Moderna"; IMMUNISATION (non-serious) with onset 18Dec2021 11:30, outcome "unknown", described as "Booster"; MIGRAINE (non-serious) with onset 19Dec2021 08:00, outcome "recovering", described as "Migraine"; LYMPHADENOPATHY (non-serious) with onset 19Dec2021 08:00, outcome "recovering", described as "Swollen lymph node in underarm"; FATIGUE (non-serious) with onset 19Dec2021 08:00, outcome "recovering", described as "Extreme fatigue"; DIZZINESS (non-serious) with onset 19Dec2021 08:00, outcome "recovering", described as "Light headedness"; NAUSEA (non-serious) with onset 19Dec2021 08:00, outcome "recovering", described as "Nausea"; DECREASED APPETITE (non-serious) with onset 19Dec2021 08:00, outcome "recovering", described as "Loss of appetite". Therapeutic measures were not taken as a result of migraine, lymphadenopathy, fatigue, dizziness, nausea, decreased appetite.Additional Information:Prior vaccination within 4 weeks was reported as none. Prior vaccination patient was not diagnosed with COVID-19 and since the vaccination the patient had not been tested for COVID-19.No follow-up attempts are possible. No further information is expected.
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscular weakness
Clinical narrative: really knocked down by the vaccine; feeling weakening in her muscles; This is a spontaneous report received from contactable reporters (Consumer). The reporter is the parent. A 22-year-old female patient received BNT162B2 (PFIZER-BIONTECH COVID-19 VACCINE), administration date 23Feb2021 (Lot number: EN6202) as dose 1, single and administration date 16Mar2021 (Lot number: EN6207) as dose 2, single; both at the age of 21 years for COVID-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. The following information was reported: MALAISE (medically significant) with onset 2021, outcome "unknown", described as "really knocked down by the vaccine"; MUSCULAR WEAKNESS (medically significant) with onset 2021, outcome "unknown", described as "feeling weakening in her muscles". Clinical course details: The patient reported that when she got the booster dose, she started feeling weakening in her muscles and maybe was really knocked down by the vaccine which it was also how she felt after the first and second doses of the Pfizer COVID vaccine.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Immunisation, Pruritus, Pulmonary mass, Rash
Clinical narrative: Booster; Yearly lung scan that is normally clear now shows spot all over; whole body rash and itching; whole body rash and itching; Allergy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Sep2021 12:00 (Lot number: 30145BA) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9263, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 29Jan2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "After the second dose itchy skin that did not go away"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL1283, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 08Jan2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Sep2021 12:00, outcome "unknown", described as "Booster"; PULMONARY MASS (non-serious) with onset 2021, outcome "unknown", described as "Yearly lung scan that is normally clear now shows spot all over"; RASH (non-serious), PRURITUS (non-serious) all with onset 2021, outcome "not recovered" and all described as "whole body rash and itching"; HYPERSENSITIVITY (non-serious) with onset 2021, outcome "not recovered", described as "Allergy". The events "yearly lung scan that is normally clear now shows spot all over", "whole body rash and itching", "whole body rash and itching" and "allergy" 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 rash, pruritus, hypersensitivity. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination.  Follow-up attempts are completed. No further information is expected.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Ventilation/perfusion scan
Clinical narrative: Booster; Yearly lung scan that is normally clear now shows spot all over; whole body rash and itching; whole body rash and itching; Allergy; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76 year-old male patient received bnt162b2 (BNT162B2), administered in arm right, administration date 28Sep2021 12:00 (Lot number: 30145BA) at the age of 76 years as dose 3 (booster), single for covid-19 immunisation. Relevant medical history included: "High cholesterol" (unspecified if ongoing). The patient had no known allergies. Concomitant medication(s) included: ATORVASTATIN. Vaccination history included: Bnt162b2 (Dose Number: 2, Batch/Lot No: EL9263, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 29Jan2021, when the patient was 75 years old, for COVID-19 immunization, reaction(s): "After the second dose itchy skin that did not go away"; Bnt162b2 (Dose Number: 1, Batch/Lot No: EL1283, Location of injection: Arm Right, Vaccine Administration Time: 12:00 PM), administration date: 08Jan2021, when the patient was 75 years old, for COVID-19 immunization. The following information was reported: IMMUNISATION (non-serious) with onset 28Sep2021 12:00, outcome "unknown", described as "Booster"; PULMONARY MASS (non-serious) with onset 2021, outcome "unknown", described as "Yearly lung scan that is normally clear now shows spot all over"; RASH (non-serious), PRURITUS (non-serious) all with onset 2021, outcome "not recovered" and all described as "whole body rash and itching"; HYPERSENSITIVITY (non-serious) with onset 2021, outcome "not recovered", described as "Allergy". The events "yearly lung scan that is normally clear now shows spot all over", "whole body rash and itching", "whole body rash and itching" and "allergy" 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 rash, pruritus, hypersensitivity. The patient did not have COVID-19 prior to vaccination and was not tested for COVID-19 post vaccination.  Follow-up attempts are completed. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Blood urine present, Immunisation, Joint effusion, Joint swelling, Nephrolithiasis
Clinical narrative: I had some side effect from the booster of Pfizer; I have a kidney stone; blood in my urine; my left knee blew up like I have tons of fluid in it; my left knee blew up like I have tons of fluid in it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Primary Immunization series complete but unknown manufacturer. I didn't have any side effects with the two, the first two vaccine), for Covid-19 immunization, reaction(s): "No adverse effect"; Covid-19 vaccine (Dose: 2, Primary Immunization series complete but unknown manufacturer. I didn't have any side effects with the two, the first two vaccine), for Covid-19 immunization, reaction(s): "No adverse effect". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "I had some side effect from the booster of Pfizer"; NEPHROLITHIASIS (medically significant), outcome "unknown", described as "I have a kidney stone"; BLOOD URINE PRESENT (non-serious), outcome "unknown", described as "blood in my urine"; JOINT SWELLING (non-serious), JOINT EFFUSION (non-serious), outcome "unknown" and all described as "my left knee blew up like I have tons of fluid in it". The patient underwent the following laboratory tests and procedures: urine analysis: blood. It was reported that, patient three days of blood in urine after got the booster, within the couple of hours after the booster and also left knee blew up like I have tons of fluid in it. Patient did go to doctor and they said did have blood in urine but patient did not have an infection and patient went to neurologist because patient had a kidney stone (Further clarification unknown) and he said patient's kidney is look fine. Patient wanted to know if there is another people that have this problem, patient didn't have any side effects with the two, the first two vaccine, it was just the booster that caused this problem.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Urine analysis
Clinical narrative: I had some side effect from the booster of Pfizer; I have a kidney stone; blood in my urine; my left knee blew up like I have tons of fluid in it; my left knee blew up like I have tons of fluid in it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Primary Immunization series complete but unknown manufacturer. I didn't have any side effects with the two, the first two vaccine), for Covid-19 immunization, reaction(s): "No adverse effect"; Covid-19 vaccine (Dose: 2, Primary Immunization series complete but unknown manufacturer. I didn't have any side effects with the two, the first two vaccine), for Covid-19 immunization, reaction(s): "No adverse effect". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "I had some side effect from the booster of Pfizer"; NEPHROLITHIASIS (medically significant), outcome "unknown", described as "I have a kidney stone"; BLOOD URINE PRESENT (non-serious), outcome "unknown", described as "blood in my urine"; JOINT SWELLING (non-serious), JOINT EFFUSION (non-serious), outcome "unknown" and all described as "my left knee blew up like I have tons of fluid in it". The patient underwent the following laboratory tests and procedures: urine analysis: blood. It was reported that, patient three days of blood in urine after got the booster, within the couple of hours after the booster and also left knee blew up like I have tons of fluid in it. Patient did go to doctor and they said did have blood in urine but patient did not have an infection and patient went to neurologist because patient had a kidney stone (Further clarification unknown) and he said patient's kidney is look fine. Patient wanted to know if there is another people that have this problem, patient didn't have any side effects with the two, the first two vaccine, it was just the booster that caused this problem.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Haemorrhage, Investigation
Clinical narrative: I had some side effect from the booster of Pfizer; I have a kidney stone; blood in my urine; my left knee blew up like I have tons of fluid in it; my left knee blew up like I have tons of fluid in it; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 (BNT162B2) (Batch/Lot number: unknown) as dose 3 (booster), single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose: 1, Primary Immunization series complete but unknown manufacturer. I didn't have any side effects with the two, the first two vaccine), for Covid-19 immunization, reaction(s): "No adverse effect"; Covid-19 vaccine (Dose: 2, Primary Immunization series complete but unknown manufacturer. I didn't have any side effects with the two, the first two vaccine), for Covid-19 immunization, reaction(s): "No adverse effect". The following information was reported: IMMUNISATION (medically significant), outcome "unknown", described as "I had some side effect from the booster of Pfizer"; NEPHROLITHIASIS (medically significant), outcome "unknown", described as "I have a kidney stone"; BLOOD URINE PRESENT (non-serious), outcome "unknown", described as "blood in my urine"; JOINT SWELLING (non-serious), JOINT EFFUSION (non-serious), outcome "unknown" and all described as "my left knee blew up like I have tons of fluid in it". The patient underwent the following laboratory tests and procedures: urine analysis: blood. It was reported that, patient three days of blood in urine after got the booster, within the couple of hours after the booster and also left knee blew up like I have tons of fluid in it. Patient did go to doctor and they said did have blood in urine but patient did not have an infection and patient went to neurologist because patient had a kidney stone (Further clarification unknown) and he said patient's kidney is look fine. Patient wanted to know if there is another people that have this problem, patient didn't have any side effects with the two, the first two vaccine, it was just the booster that caused this problem.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Cellulitis, Injury
Clinical narrative: Cellulitis / due to injury on lower leg; Cellulitis / due to injury on lower leg; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65 year-old female patient (not pregnant) received bnt162b2 (BNT162B2), administered in arm left, administration date 23Mar2021 12:00 (Lot number: ER8730) at the age of 64 years as dose 2, single for covid-19 immunisation. Relevant medical history included: "known allergies: Sulfa drugs" (unspecified if ongoing). The patient's concomitant medications were not reported. Vaccination history included: Bnt162b2 (Dose 1, single, Lot number=EN6205, Administration time= 12:00 PM, Vaccine location=Left arm), administration date: 02Mar2021, when the patient was 65 years old, for Covid-19 immunization. Prior to vaccination, the patient did not have COVID-19 and since vaccination, has not been tested for COVID-19. The following information was reported: CELLULITIS (medically significant), INJURY (non-serious) all with onset Jul2021, outcome "unknown" and all described as "Cellulitis / due to injury on lower leg".