chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Pruritus, Swollen tongue
Clinical narrative: itchy face Narrative: Moderate anaphylaxis reaction after administration of dose #1 Pfizer covid-19 vaccine. Tongue swelling and facial itching. Epi administered xl, patient transported to local ER for follow-up care.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Palpitations
Clinical narrative: Narrative: Pt. reported to the local ER where he was treated for rapid heartbeat.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Lethargy
Clinical narrative: lethargy x2 days Narrative:
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Dizziness, Heart rate decreased, Myalgia, Neuropathy peripheral
Clinical narrative: Patient reported low HR 1/27/21 (one day after vaccine) and went to ER. Patient reports no interventions at hospital and he was not admitted. Patient slept for 5 days after vaccination. He experienced joint/muscle pain and occasional dizziness which has continued at 8 weeks post vaccination. Patient also reports neuropathy which started in half of foot and progressed to leg (below the knee). He uses acetaminophen and DMSO for pain.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: injection site pain Narrative:
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: injection site pain Narrative:
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Headache, Hyperhidrosis, Incomplete course of vaccination, Orthostatic hypotension
Clinical narrative: 74 Y.O. received COVID-19 Vaccine 12/28/2020 and subsequently developed orthostatic hypotension, visual changes, headache, lightheadedness, and diaphoresis. Patient was transferred to local ED for further assessment to r/o MI, CVA, vasovagal rxn, or vaccine rxn. Patient monitored, no treatment required, discharged home. Patient did not receive 2nd COVID-19 vaccine d/t rxn with 1st vaccine.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Visual impairment
Clinical narrative: 74 Y.O. received COVID-19 Vaccine 12/28/2020 and subsequently developed orthostatic hypotension, visual changes, headache, lightheadedness, and diaphoresis. Patient was transferred to local ED for further assessment to r/o MI, CVA, vasovagal rxn, or vaccine rxn. Patient monitored, no treatment required, discharged home. Patient did not receive 2nd COVID-19 vaccine d/t rxn with 1st vaccine.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Gout
Clinical narrative: gout Narrative:
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, Myalgia, chills, fatigue Narrative: Received 1st covid vaccine on 3/22/21 at 3 pm around 4 hours later started experieicning headache, muscle aches, chills, and fatigued. She went to bed and took ibuprofen. Still reports muscle aches and fatigue. Advised normal side effects of vaccine and should subside in the next day or two.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: shortness of breath Narrative:
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Night sweats
Clinical narrative: Diarrhea GI upset, Night Sweats, Chills x 2 days Narrative:
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Unevaluable event
Clinical narrative: Slightly sore arm less than 12 hours
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Pain in extremity
Clinical narrative: Slightly sore arm less than 12 hours
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Blood potassium decreased, Cardiac function test normal, Chills, Fatigue
Clinical narrative: - initial chills, fever - same leg "freezed" as first shot reported - 4 days later, anaphylactic event - ER 3/15/2021 - continued fatigue and nausea   Chills, Fever, nausea leg stiffness as in first shot ( 2/11/21)  4 days later - ER - anaphylactic event (epipen used) 3/15/21 - continued fatigue and nausea persists as well as leg limp 3/23/21
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Gait disturbance, Laboratory test, Monoplegia, Musculoskeletal stiffness, Nausea
Clinical narrative: - initial chills, fever - same leg "freezed" as first shot reported - 4 days later, anaphylactic event - ER 3/15/2021 - continued fatigue and nausea   Chills, Fever, nausea leg stiffness as in first shot ( 2/11/21)  4 days later - ER - anaphylactic event (epipen used) 3/15/21 - continued fatigue and nausea persists as well as leg limp 3/23/21
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: - initial chills, fever - same leg "freezed" as first shot reported - 4 days later, anaphylactic event - ER 3/15/2021 - continued fatigue and nausea   Chills, Fever, nausea leg stiffness as in first shot ( 2/11/21)  4 days later - ER - anaphylactic event (epipen used) 3/15/21 - continued fatigue and nausea persists as well as leg limp 3/23/21
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Diarrhoea, Fatigue, Headache, Muscular weakness
Clinical narrative: After injection, headache on Tuesday.  Wednesday, increase in  tremors in hands, extremely tired-unable to stay awake, diaherra 2 times, cold like symtoms (scratchy throat), headache, very weak legs. Thursday more strength in legs upon getting up, but after breakfast took a nap and had a very difficult time gettting out of chair, weak legs and no strength in legs or arms, diaherra 2 times so far today, dull headache in AM but went away, in afternoon nose runny, tremors still very bad,. No loss in appetite since injection.
Age: 78.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis, Rhinorrhoea, Throat irritation, Tremor
Clinical narrative: After injection, headache on Tuesday.  Wednesday, increase in  tremors in hands, extremely tired-unable to stay awake, diaherra 2 times, cold like symtoms (scratchy throat), headache, very weak legs. Thursday more strength in legs upon getting up, but after breakfast took a nap and had a very difficult time gettting out of chair, weak legs and no strength in legs or arms, diaherra 2 times so far today, dull headache in AM but went away, in afternoon nose runny, tremors still very bad,. No loss in appetite since injection.
Age: 83.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Condition aggravated, Eye pain, Photophobia, Vision blurred
Clinical narrative: Patient had headache with the first dose of PFIZER COVID-19 vaccine at 02/27/2021 then experienced pain in the the eye ball (right side) after the second dose at 03/17/2021  the pain giving the patient sensitivity for lights as well as blurred vision.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Blood test, Electrocardiogram, Electrocardiogram ambulatory, Syncope
Clinical narrative: Client woke on 3/18/21 in AM to go to Bathroom.  While client was walking to her residential bathroom. Client stated to writer she fainted 3 times and Husband had to help her.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: Patient developed a dark rash surrounding injection area of left arm on 3/22 and she went to the ER and was given Benadryl (tablet) and 3 tablets of Prednisone. After treatment condition improved.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Anticoagulant therapy, Chest pain, Chills, Computerised tomogram thorax abnormal, Decreased appetite
Clinical narrative: After receiving 2nd COVID on 2/17/21 - pt started with chills, fever, decreased appetite, increased shortness of breath and pleurtic pain. Left sided chest pain. Patient started on xarelto 3/2/21 - using oxygen continous. Will continue on xarelto and follow up in clinic 6/17/21.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dyspnoea, Fibrin D dimer increased, Pleuritic pain, Pulmonary embolism, Pyrexia
Clinical narrative: After receiving 2nd COVID on 2/17/21 - pt started with chills, fever, decreased appetite, increased shortness of breath and pleurtic pain. Left sided chest pain. Patient started on xarelto 3/2/21 - using oxygen continous. Will continue on xarelto and follow up in clinic 6/17/21.
Age: 80.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Ultrasound Doppler normal
Clinical narrative: After receiving 2nd COVID on 2/17/21 - pt started with chills, fever, decreased appetite, increased shortness of breath and pleurtic pain. Left sided chest pain. Patient started on xarelto 3/2/21 - using oxygen continous. Will continue on xarelto and follow up in clinic 6/17/21.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pruritus, Swelling face
Clinical narrative: Got 1st COVID Vaccine (Moderna) 3/4/21  3 days later started w/facial itching redness 3/7/2021 next Day woke up w/facial swelling too.   Dx facial swelling Rx Solumedrol 125mg/IM    Prednisone 10 Day Taper 20 mg
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: 1 day after the vaccination the Patient started with severe jaw pain with not improvement of the  symptoms after 2 weeks of the initial symptom.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Dizziness- a few hs after getting the vaccine plus nausea. Lump/Red/heated at injection site Headache
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: Dizziness- a few hs after getting the vaccine plus nausea. Lump/Red/heated at injection site Headache
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Tongue pruritus
Clinical narrative: Pt states just after sitting down in observation area she noticed tongue itching. About 20 mins later (1:53) she notified staff that she had tongue itching and arms itching. VS taken: P 85, BP 147/96, SaO2 98%. Pt in NO acute distress, states symptoms NOT as severe as in past when has had anaphylaxis. Does not feel she need epinephrine. Posterior oropharynx without noted edema, airway wide + patient
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bell's palsy, Drooling, Facial paralysis, Facial paresis, Hypogeusia
Clinical narrative: 3/1/21 R facial Droop / R sided weakness, drooling & not able to taste well DX: Bells Palsy Rx: Prednisone 40mg x 5 Days Valtrex 1000mg TiD x 7 Days.
Sex: U
Vaccine: FLUR4
Symptoms: Foetal exposure during pregnancy, Foetal hypokinesia
Clinical narrative: Initial information was received on 13-Mar-2021 regarding an unsolicited valid serious case from other health care professional, issued from a literature article.   Literature Citation:  This case is linked to cases 2021SA091226, 2021SA091252, 2021SA091271, 2021SA091286, 2021SA091303, 2021SA091334, 2021SA091349, 2021SA091366, 2021SA091398, 2021SA091448, 2021SA091468, 2021SA091489, 2021SA091516, 2021SA091556, 2021SA091604, 2021SA091690, 2021SA091782, 2021SA091798, 2021SA091833, 2021SA091855 and 2021SA091879 (same article).  This case involves a fetus who had vaccine exposure in utero (fetal exposure during pregnancy) and developed fetal hypokinesia (fetal hypokinesia) whose mother received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  The patient's mother medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.   On an unknown date, the patients mother received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for prophylactic vaccination and fetus exposed to vaccine via transplacental route (Fetal exposure during pregnancy).  On an unknown date, the patient was diagnosed with serious fetal hypokinesia, unknown latency following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE. This event was assessed as medically significant.  It was reported that Among 22 reports of FLUBLOK QUADRIVALENT vaccination in pregnant or lactating women, a large majority (17; 77 %) did not describe any adverse event per se. Of the remaining five reports, two described allergic reactions, including one report of positive rechallenge (i.e., similar response to a previous dose of FLUBLOK QUADRIVALENT) and one report of an allergic reaction that may have been related to latex in a concomitantly administered vaccine. One report described pruritus and fetal hypokinesia. One-person experienced asthenia, fatigue, feeling hot, headache and hyperhidrosis. One person was hospitalized for hypertension, bradycardia, headache and swelling neuropathy. None of the reports included information about the trimester of exposure or any pregnancy outcomes (e.g., live birth). Details of laboratory data were not reported. It was not reported if any corrective treatment was provided. The outcome of the event fetal hypokinesia was not reported at the time of reporting.  Information on batch number was requested for this case. Sender's Comments: This case concerns a fetus patient who had fetal exposure during pregnancy and developed fetal hypokinesia, after mother received the FLUBLOK QIV. The time to onset is unknown. The patient's mother medical history, medical condition at time of vaccination, concomitant medication and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of vaccine cannot be assessed.
Age: 11.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Asthma, Blood test, Bursitis infective, Cellulitis, Gangrene
Clinical narrative: [Principal]Sepsis, unspecified organism YesNoNoYesI96 Gangrene, not elsewhere classified YesCCNoYesL03.114 Cellulitis of left upper limbYesCCNoNoD69.6 Thrombocytopenia, unspecified YesNoM71.122 Other infective bursitis, left elbowYesNoS50.312AAbrasion of left elbow, initial encounterYesNoJ45.20Mild intermittent asthma, uncomplicatedYesNoB27.99Infectious mononucleosis, unspecified with other complicationYes
Age: 11.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Infectious mononucleosis, Laboratory test, Sepsis, Skin abrasion, Surgery
Clinical narrative: [Principal]Sepsis, unspecified organism YesNoNoYesI96 Gangrene, not elsewhere classified YesCCNoYesL03.114 Cellulitis of left upper limbYesCCNoNoD69.6 Thrombocytopenia, unspecified YesNoM71.122 Other infective bursitis, left elbowYesNoS50.312AAbrasion of left elbow, initial encounterYesNoJ45.20Mild intermittent asthma, uncomplicatedYesNoB27.99Infectious mononucleosis, unspecified with other complicationYes
Age: 11.0
Sex: M
Vaccine: IPV, MMR
Symptoms: Thrombocytopenia
Clinical narrative: [Principal]Sepsis, unspecified organism YesNoNoYesI96 Gangrene, not elsewhere classified YesCCNoYesL03.114 Cellulitis of left upper limbYesCCNoNoD69.6 Thrombocytopenia, unspecified YesNoM71.122 Other infective bursitis, left elbowYesNoS50.312AAbrasion of left elbow, initial encounterYesNoJ45.20Mild intermittent asthma, uncomplicatedYesNoB27.99Infectious mononucleosis, unspecified with other complicationYes
Sex: F
Vaccine: FLUR4
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Initial information received on 13-Mar-2021 regarding an unsolicited valid serious case from other health care professional, issued from a literature article.  Literature Citation:  This case is linked to cases 2021SA091226, 2021SA091252, 2021SA091271, 2021SA091286, 2021SA091303, 2021SA091334, 2021SA091349, 2021SA091366, 2021SA091398, 2021SA091448, 2021SA091468, 2021SA091516, 2021SA091556, 2021SA091604, 2021SA091690, 2021SA091745, 2021SA091782, 2021SA091798, 2021SA091833, 2021SA091855 and 2021SA091879 (same article).  This case involves a 69-year-old female patient who experienced Steven Johnson Syndrome, while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] and while treated with LISINOPRIL and ATORVASTATIN.  The patient's medical history, past medical treatment(s), concomitant therapy, vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date not reported) via an unknown route at an unknown administration site for vaccination.  On an unknown date, the patient started taking LISINOPRIL and ATORVASTATIN (batch number and expiry date not reported) dosage and route unknown for an unknown indication.  On an unknown date, the patient developed serious Steven Johnson Syndrome (Stevens-Johnson Syndrome) 8 days following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE and approximately 2 weeks following the intake of LISINOPRIL and ATORVASTATIN. This event was assessed as medically significant.  Details of laboratory data were not reported.  Action taken for LISINOPRIL and ATORVASTATIN was unknown.  It was not reported if the patient received any corrective treatment.  Outcome of the event was not reported, and no additional details were provided.  Information on the batch number was requested. Sender's Comments: This case involves a 69-year-old female patient who experienced Steven Johnson Syndrome 8 days after administration of FLUBLOK QIV, and approximately 2 weeks after intake of LISINOPRIL and ATORVASTATIN. The time to onset was compatible. Further information regarding concurrent condition during product administration, previous product administration and tolerance, allergic history, laboratory investigations excluding alternative etiologies for the reported event are needed to fully assess this case. Based upon the reported information, the role of an individual vaccine cannot be assessed, while the role of suspect product cannot be excluded.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Alopecia, Anaemia, Antinuclear antibody positive, Arthralgia, Biopsy kidney abnormal
Clinical narrative: lupus; allergy to flagyl and PCN; lupus nephritis; This spontaneous report was received from a physician and refers to a 12-year-old male patient. The patient's concomitant medications included claritin. The patient's medical histories and concurrent conditions were not provided. The patient was allergic to penicillin (PCN) and metronidazole (FLAGYL).  On unspecified date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, strength, route of administration, lot # and expiration date were not provided) for prophylaxis. On 29-JUL-2020, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 ml, intramuscularly( lot # S010729 with expiration date 01-DEC-2021). The patient developed lupus after administration of second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). He also developed rash on face three days after administration of vaccine. Then developed more rashes and fatigue. On 14-AUG-2020, found to have elevated antinuclear antibodies (ANA). Fatigue, hair loss, rashes and joint pain continued. The patient saw allergist and primary care physician (PCP) over next several months. The patient was hospitalized since 15-FEB-2021 until 20-FEB-2021, for anemia and neutropenia and was diagnosed with lupus. The patient had kidney biopsy on unspecified date, and found to have lupus nephritis. The patient was treated with steroids. Caller no longer had syringe for return. The outcome of lupus and lupus nephritis was reported as recovering. The outcome of drug hypersensitivity was not provided. It was reported that therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Upon internal review, the events of lupus nephritis and lupus was considered to be medically significant. Combination product report: Yes; brand name: GARDASIL 9 SYRINGE (DEVICE); common device name: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp. device lot number: S010729; expiration date: 01-DEC-2021; device age and unit: malfunction: Unknown; product available for evaluation: No; device usage: Initial; reason for non eval: 81 Other; labeled single use device: No; mdcp reportability: No; mdcp reprationale: Case information does not suggest a causal association with the device or device constituent.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Double stranded DNA antibody positive, Erythema multiforme, Fatigue, Feeling abnormal, Glomerulonephritis
Clinical narrative: lupus; allergy to flagyl and PCN; lupus nephritis; This spontaneous report was received from a physician and refers to a 12-year-old male patient. The patient's concomitant medications included claritin. The patient's medical histories and concurrent conditions were not provided. The patient was allergic to penicillin (PCN) and metronidazole (FLAGYL).  On unspecified date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, strength, route of administration, lot # and expiration date were not provided) for prophylaxis. On 29-JUL-2020, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 ml, intramuscularly( lot # S010729 with expiration date 01-DEC-2021). The patient developed lupus after administration of second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). He also developed rash on face three days after administration of vaccine. Then developed more rashes and fatigue. On 14-AUG-2020, found to have elevated antinuclear antibodies (ANA). Fatigue, hair loss, rashes and joint pain continued. The patient saw allergist and primary care physician (PCP) over next several months. The patient was hospitalized since 15-FEB-2021 until 20-FEB-2021, for anemia and neutropenia and was diagnosed with lupus. The patient had kidney biopsy on unspecified date, and found to have lupus nephritis. The patient was treated with steroids. Caller no longer had syringe for return. The outcome of lupus and lupus nephritis was reported as recovering. The outcome of drug hypersensitivity was not provided. It was reported that therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Upon internal review, the events of lupus nephritis and lupus was considered to be medically significant. Combination product report: Yes; brand name: GARDASIL 9 SYRINGE (DEVICE); common device name: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp. device lot number: S010729; expiration date: 01-DEC-2021; device age and unit: malfunction: Unknown; product available for evaluation: No; device usage: Initial; reason for non eval: 81 Other; labeled single use device: No; mdcp reportability: No; mdcp reprationale: Case information does not suggest a causal association with the device or device constituent.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Haematocrit decreased, Haemoglobin decreased, Leukopenia, Lupus nephritis, Mouth ulceration
Clinical narrative: lupus; allergy to flagyl and PCN; lupus nephritis; This spontaneous report was received from a physician and refers to a 12-year-old male patient. The patient's concomitant medications included claritin. The patient's medical histories and concurrent conditions were not provided. The patient was allergic to penicillin (PCN) and metronidazole (FLAGYL).  On unspecified date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, strength, route of administration, lot # and expiration date were not provided) for prophylaxis. On 29-JUL-2020, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 ml, intramuscularly( lot # S010729 with expiration date 01-DEC-2021). The patient developed lupus after administration of second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). He also developed rash on face three days after administration of vaccine. Then developed more rashes and fatigue. On 14-AUG-2020, found to have elevated antinuclear antibodies (ANA). Fatigue, hair loss, rashes and joint pain continued. The patient saw allergist and primary care physician (PCP) over next several months. The patient was hospitalized since 15-FEB-2021 until 20-FEB-2021, for anemia and neutropenia and was diagnosed with lupus. The patient had kidney biopsy on unspecified date, and found to have lupus nephritis. The patient was treated with steroids. Caller no longer had syringe for return. The outcome of lupus and lupus nephritis was reported as recovering. The outcome of drug hypersensitivity was not provided. It was reported that therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Upon internal review, the events of lupus nephritis and lupus was considered to be medically significant. Combination product report: Yes; brand name: GARDASIL 9 SYRINGE (DEVICE); common device name: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp. device lot number: S010729; expiration date: 01-DEC-2021; device age and unit: malfunction: Unknown; product available for evaluation: No; device usage: Initial; reason for non eval: 81 Other; labeled single use device: No; mdcp reportability: No; mdcp reprationale: Case information does not suggest a causal association with the device or device constituent.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Nasal congestion, Nausea, Polyarthritis, Rash, Systemic lupus erythematosus
Clinical narrative: lupus; allergy to flagyl and PCN; lupus nephritis; This spontaneous report was received from a physician and refers to a 12-year-old male patient. The patient's concomitant medications included claritin. The patient's medical histories and concurrent conditions were not provided. The patient was allergic to penicillin (PCN) and metronidazole (FLAGYL).  On unspecified date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, strength, route of administration, lot # and expiration date were not provided) for prophylaxis. On 29-JUL-2020, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 ml, intramuscularly( lot # S010729 with expiration date 01-DEC-2021). The patient developed lupus after administration of second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). He also developed rash on face three days after administration of vaccine. Then developed more rashes and fatigue. On 14-AUG-2020, found to have elevated antinuclear antibodies (ANA). Fatigue, hair loss, rashes and joint pain continued. The patient saw allergist and primary care physician (PCP) over next several months. The patient was hospitalized since 15-FEB-2021 until 20-FEB-2021, for anemia and neutropenia and was diagnosed with lupus. The patient had kidney biopsy on unspecified date, and found to have lupus nephritis. The patient was treated with steroids. Caller no longer had syringe for return. The outcome of lupus and lupus nephritis was reported as recovering. The outcome of drug hypersensitivity was not provided. It was reported that therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Upon internal review, the events of lupus nephritis and lupus was considered to be medically significant. Combination product report: Yes; brand name: GARDASIL 9 SYRINGE (DEVICE); common device name: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp. device lot number: S010729; expiration date: 01-DEC-2021; device age and unit: malfunction: Unknown; product available for evaluation: No; device usage: Initial; reason for non eval: 81 Other; labeled single use device: No; mdcp reportability: No; mdcp reprationale: Case information does not suggest a causal association with the device or device constituent.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Weight decreased
Clinical narrative: lupus; allergy to flagyl and PCN; lupus nephritis; This spontaneous report was received from a physician and refers to a 12-year-old male patient. The patient's concomitant medications included claritin. The patient's medical histories and concurrent conditions were not provided. The patient was allergic to penicillin (PCN) and metronidazole (FLAGYL).  On unspecified date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, strength, route of administration, lot # and expiration date were not provided) for prophylaxis. On 29-JUL-2020, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 ml, intramuscularly( lot # S010729 with expiration date 01-DEC-2021). The patient developed lupus after administration of second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). He also developed rash on face three days after administration of vaccine. Then developed more rashes and fatigue. On 14-AUG-2020, found to have elevated antinuclear antibodies (ANA). Fatigue, hair loss, rashes and joint pain continued. The patient saw allergist and primary care physician (PCP) over next several months. The patient was hospitalized since 15-FEB-2021 until 20-FEB-2021, for anemia and neutropenia and was diagnosed with lupus. The patient had kidney biopsy on unspecified date, and found to have lupus nephritis. The patient was treated with steroids. Caller no longer had syringe for return. The outcome of lupus and lupus nephritis was reported as recovering. The outcome of drug hypersensitivity was not provided. It was reported that therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Upon internal review, the events of lupus nephritis and lupus was considered to be medically significant. Combination product report: Yes; brand name: GARDASIL 9 SYRINGE (DEVICE); common device name: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp. device lot number: S010729; expiration date: 01-DEC-2021; device age and unit: malfunction: Unknown; product available for evaluation: No; device usage: Initial; reason for non eval: 81 Other; labeled single use device: No; mdcp reportability: No; mdcp reprationale: Case information does not suggest a causal association with the device or device constituent.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Alopecia, Anaemia, Antinuclear antibody increased, Arthralgia, Biopsy kidney
Clinical narrative: lupus; allergy to flagyl and PCN; lupus nephritis; This spontaneous report was received from a physician and refers to a 12-year-old male patient. The patient's concomitant medications included claritin. The patient's medical histories and concurrent conditions were not provided. The patient was allergic to penicillin (PCN) and metronidazole (FLAGYL).  On unspecified date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, strength, route of administration, lot # and expiration date were not provided) for prophylaxis. On 29-JUL-2020, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 ml, intramuscularly( lot # S010729 with expiration date 01-DEC-2021). The patient developed lupus after administration of second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). He also developed rash on face three days after administration of vaccine. Then developed more rashes and fatigue. On 14-AUG-2020, found to have elevated antinuclear antibodies (ANA). Fatigue, hair loss, rashes and joint pain continued. The patient saw allergist and primary care physician (PCP) over next several months. The patient was hospitalized since 15-FEB-2021 until 20-FEB-2021, for anemia and neutropenia and was diagnosed with lupus. The patient had kidney biopsy on unspecified date, and found to have lupus nephritis. The patient was treated with steroids. Caller no longer had syringe for return. The outcome of lupus and lupus nephritis was reported as recovering. The outcome of drug hypersensitivity was not provided. It was reported that therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Upon internal review, the events of lupus nephritis and lupus was considered to be medically significant. Combination product report: Yes; brand name: GARDASIL 9 SYRINGE (DEVICE); common device name: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp. device lot number: S010729; expiration date: 01-DEC-2021; device age and unit: malfunction: Unknown; product available for evaluation: No; device usage: Initial; reason for non eval: 81 Other; labeled single use device: No; mdcp reportability: No; mdcp reprationale: Case information does not suggest a causal association with the device or device constituent.
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Fatigue, Lupus nephritis, Neutropenia, Rash, Systemic lupus erythematosus
Clinical narrative: lupus; allergy to flagyl and PCN; lupus nephritis; This spontaneous report was received from a physician and refers to a 12-year-old male patient. The patient's concomitant medications included claritin. The patient's medical histories and concurrent conditions were not provided. The patient was allergic to penicillin (PCN) and metronidazole (FLAGYL).  On unspecified date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9)(dose, strength, route of administration, lot # and expiration date were not provided) for prophylaxis. On 29-JUL-2020, the patient was vaccinated with a second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9), 0.5 ml, intramuscularly( lot # S010729 with expiration date 01-DEC-2021). The patient developed lupus after administration of second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9). He also developed rash on face three days after administration of vaccine. Then developed more rashes and fatigue. On 14-AUG-2020, found to have elevated antinuclear antibodies (ANA). Fatigue, hair loss, rashes and joint pain continued. The patient saw allergist and primary care physician (PCP) over next several months. The patient was hospitalized since 15-FEB-2021 until 20-FEB-2021, for anemia and neutropenia and was diagnosed with lupus. The patient had kidney biopsy on unspecified date, and found to have lupus nephritis. The patient was treated with steroids. Caller no longer had syringe for return. The outcome of lupus and lupus nephritis was reported as recovering. The outcome of drug hypersensitivity was not provided. It was reported that therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was discontinued.   The causal relationship between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) was not provided.  Upon internal review, the events of lupus nephritis and lupus was considered to be medically significant. Combination product report: Yes; brand name: GARDASIL 9 SYRINGE (DEVICE); common device name: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); product code: FMF; device type: SYRINGE, PISTON (FMF); manufacturer name: Merck Sharp & Dohme Corp. device lot number: S010729; expiration date: 01-DEC-2021; device age and unit: malfunction: Unknown; product available for evaluation: No; device usage: Initial; reason for non eval: 81 Other; labeled single use device: No; mdcp reportability: No; mdcp reprationale: Case information does not suggest a causal association with the device or device constituent.
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Dizziness, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Patient here for COVID 19 vaccine Arrived to drive through as passenger in car.   He did let RN know before vaccine he has felt faint and has had syncopal episodes after injections or blood draws. Immediately  after injection he had a loss of conciseness. Lasting approximately 1min.  Partner states this was a normal reaction. He then had a second episode lasting longer than first. Partner states this is not a normal reaction for him. He was not responding to voice or touch after approximately 1-2 mins he was alert and responsesive to person, place and situation. RN stayed with Patient as he remained in car.     911 called to evaluate RN gave report and hand of to EMS. per  RN
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Erythema, Feeling cold, Nausea, Throat irritation, Tongue oedema
Clinical narrative: This could certainly represent allergic reaction which she has had the vaccines in the past.  She has sensation of tongue edema and scratchiness in her throat, does have erythema of her face and anterior neck, has mild wheezing on exam. She is treated with epinephrine 0.3 mg IM, followed by IV, Solu-Medrol 125 mg, famotidine 20 mg, Benadryl 25 mg, NS 1 L, and improves over several hours.  At no point did she worsen or express a desire to have an additional epinephrine dose.  She was never hypotensive.  She is cold and chilled, also complained of nausea, given Zofran and a bear hugger While the wheezing was treated with albuterol inhaler and resolved   Ultimately discharged with her husband They will be picking up a EpiPen in route to home which is at a pharmacy, confirmed Prescriptions sent for Benadryl, 3 additional days of prednisone, Pepcid, albuterol inhaler   Last Set of Vital Signs: Temp: 37.2 °C (98.9 °F) Pulse: 96 Resp: 12 SpO2: 100 % BP: 132/76
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Wheezing
Clinical narrative: This could certainly represent allergic reaction which she has had the vaccines in the past.  She has sensation of tongue edema and scratchiness in her throat, does have erythema of her face and anterior neck, has mild wheezing on exam. She is treated with epinephrine 0.3 mg IM, followed by IV, Solu-Medrol 125 mg, famotidine 20 mg, Benadryl 25 mg, NS 1 L, and improves over several hours.  At no point did she worsen or express a desire to have an additional epinephrine dose.  She was never hypotensive.  She is cold and chilled, also complained of nausea, given Zofran and a bear hugger While the wheezing was treated with albuterol inhaler and resolved   Ultimately discharged with her husband They will be picking up a EpiPen in route to home which is at a pharmacy, confirmed Prescriptions sent for Benadryl, 3 additional days of prednisone, Pepcid, albuterol inhaler   Last Set of Vital Signs: Temp: 37.2 °C (98.9 °F) Pulse: 96 Resp: 12 SpO2: 100 % BP: 132/76
Age: 41.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Anaphylactic reaction, Fatigue, Neuropathy peripheral, Rash, Vascular rupture
Clinical narrative: This could certainly represent allergic reaction which she has had the vaccines in the past.  She has sensation of tongue edema and scratchiness in her throat, does have erythema of her face and anterior neck, has mild wheezing on exam. She is treated with epinephrine 0.3 mg IM, followed by IV, Solu-Medrol 125 mg, famotidine 20 mg, Benadryl 25 mg, NS 1 L, and improves over several hours.  At no point did she worsen or express a desire to have an additional epinephrine dose.  She was never hypotensive.  She is cold and chilled, also complained of nausea, given Zofran and a bear hugger While the wheezing was treated with albuterol inhaler and resolved   Ultimately discharged with her husband They will be picking up a EpiPen in route to home which is at a pharmacy, confirmed Prescriptions sent for Benadryl, 3 additional days of prednisone, Pepcid, albuterol inhaler   Last Set of Vital Signs: Temp: 37.2 °C (98.9 °F) Pulse: 96 Resp: 12 SpO2: 100 % BP: 132/76
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Throat irritation, Throat tightness
Clinical narrative: Approximately 15 minutes after vaccine administration patient started to complain of bilateral upper extremity muscle aches. After another 20 minutes she noted that she was starting to have a sensation of her throat itching and closing. EMS was called.   No acute distress noted. Patient speaking clearly and in full sentences. Airway patent and no swelling to neck, face or lips noted. Lungs clear bilaterally and moving air well. Skin warm and dry. Mild redness noted to upper chest.    Patient evaluated by EMS and discharged. Patient monitored for an additional 10 minutes without incident. Patient still complained of upper body aches but stated that she felt ok to leave. She verbalized understanding to call 911 or go to ER if symptoms change or worsen.     Attempted to call patient 12/31 @ 1741 for follow up. No answer, left message with guidance to continue to monitor symptoms and go to ER for any urgent concerns.
Age: 33.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chest discomfort, Dysgeusia, Rhinorrhoea, Throat irritation
Clinical narrative: Approximately 10 minutes after injection patient started to complain of an itchy throat and a metallic taste in her mouth. No acute distress noted. No oral, facial or throat swelling noted. Lungs clear bilaterally and patient moving air without difficulty. Skin warm and dry. Patient speaking clearly and in full sentences. Patient continued to be monitored.   Patient complained of slight chest "tightness" and increased mucus production approximately 20 minutes after initial vaccination. Upon exam no acute distress noted. Lungs clear bilaterally. Skin warm and dry. Patient speaking clearly and in full sentences. Patient able to manage oral secretions, no drooling noted. No oral, facial or throat swelling noted. No notable redness or rash observed. EMS called and arrived without incident.    Patient discharged by EMS and was advised by them to go home and take a benadryl. Discussed EMS recommendation with patient and she verbalized understanding and stated that she would call 911 or go to ER if symptoms change or worsen.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Asthenia, Balance disorder, Blood test, Dizziness, Dizziness postural
Clinical narrative: My wife was 3nights ICU and 4days at hospital . Result is GBS.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Gait disturbance, Hypoaesthesia, Injection site pruritus, Injection site rash, Insomnia
Clinical narrative: My wife was 3nights ICU and 4days at hospital . Result is GBS.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Paraesthesia, Pruritus
Clinical narrative: My wife was 3nights ICU and 4days at hospital . Result is GBS.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Acute motor-sensory axonal neuropathy, Angiogram cerebral normal, Arteriogram carotid normal, Asthenia, Ataxia
Clinical narrative: My wife was 3nights ICU and 4days at hospital . Result is GBS.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Back pain, Bilevel positive airway pressure, Bilirubin urine, Blood urine absent, CSF cell count normal
Clinical narrative: My wife was 3nights ICU and 4days at hospital . Result is GBS.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: CSF protein increased, CSF volume, CSF white blood cell count negative, Chest X-ray normal, Chest pain
Clinical narrative: My wife was 3nights ICU and 4days at hospital . Result is GBS.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Coagulation test, Computerised tomogram head abnormal, Electrocardiogram normal, Full blood count normal, Gait disturbance
Clinical narrative: My wife was 3nights ICU and 4days at hospital . Result is GBS.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Glomerular filtration rate, Glucose urine present, Grip strength decreased, Guillain-Barre syndrome, Haemangioma of bone
Clinical narrative: My wife was 3nights ICU and 4days at hospital . Result is GBS.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Headache, Hypoaesthesia, Immunoglobulin therapy, Injection site pruritus, Intensive care
Clinical narrative: My wife was 3nights ICU and 4days at hospital . Result is GBS.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Laboratory test, Magnetic resonance imaging brain abnormal, Magnetic resonance imaging spinal normal, Metabolic function test normal, Monoparesis
Clinical narrative: My wife was 3nights ICU and 4days at hospital . Result is GBS.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Nitrite urine absent, Pain in extremity, Paraesthesia, Polymerase chain reaction, Protein urine absent
Clinical narrative: My wife was 3nights ICU and 4days at hospital . Result is GBS.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pruritus, SARS-CoV-2 test negative, Sensory disturbance, Sleep disorder, Spinal osteoarthritis
Clinical narrative: My wife was 3nights ICU and 4days at hospital . Result is GBS.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Spinal retrolisthesis, Staphylococcus test negative, Toxicologic test, Urine analysis normal, Urine ketone body absent
Clinical narrative: My wife was 3nights ICU and 4days at hospital . Result is GBS.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Urine leukocyte esterase, Urobilinogen urine, Vertebral foraminal stenosis, Vertigo, White matter lesion
Clinical narrative: My wife was 3nights ICU and 4days at hospital . Result is GBS.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: pH urine normal
Clinical narrative: My wife was 3nights ICU and 4days at hospital . Result is GBS.
Age: 62.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Guillain-Barre syndrome, Intensive care, Magnetic resonance imaging head abnormal
Clinical narrative: My wife was 3nights ICU and 4days at hospital . Result is GBS.
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Hypertension
Clinical narrative: Pt reported dizziness after receiving COVID vaccine. RN responded - checked pt's vital signs. BP 220/110, SpO2 94%, HR 79. Pt reported she had not taken her BP medication. BP rechecked at 190/110. EMS called and responded, talked to patient, released her to home.
Age: 91.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure increased, Dizziness
Clinical narrative: Pt reported dizziness after receiving COVID vaccine. RN responded - checked pt's vital signs. BP 220/110, SpO2 94%, HR 79. Pt reported she had not taken her BP medication. BP rechecked at 190/110. EMS called and responded, talked to patient, released her to home.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Fatigue, Lymphadenopathy
Clinical narrative: Bilateral cervical adenopathy: swollen lymph nodes in neck, armpits and groin. Significant, obvious, very painful swelling extending around back of neck and down left arm.  No sore throat, fever.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Adenocarcinoma of the cervix, Lymphadenopathy, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Bilateral cervical adenopathy: swollen lymph nodes in neck, armpits and groin. Significant, obvious, very painful swelling extending around back of neck and down left arm.  No sore throat, fever.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Swelling
Clinical narrative: Bilateral cervical adenopathy: swollen lymph nodes in neck, armpits and groin. Significant, obvious, very painful swelling extending around back of neck and down left arm.  No sore throat, fever.