chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Brain fog, Feeling hot, Joint lock, Thirst
Clinical narrative: Woke up extremely hot. Went to get out of bed and found my knees and legs were locked up and could not be bent. Had to shuffle while holding on to wall - or an assistant. Could not sleep after this. This condition lasted for at least 12 hours and has been slowly improving since. In addition, had "brain fog" for the whole following day and had to take several naps over the course of the day - which is not usual.  Now, four days later, I am back to about 90% of where I was the day of the injection.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthropathy, Brain fog, Feeling hot, Gait disturbance, Sleep disorder
Clinical narrative: Woke up extremely hot. Went to get out of bed and found my knees and legs were locked up and could not be bent. Had to shuffle while holding on to wall - or an assistant. Could not sleep after this. This condition lasted for at least 12 hours and has been slowly improving since. In addition, had "brain fog" for the whole following day and had to take several naps over the course of the day - which is not usual.  Now, four days later, I am back to about 90% of where I was the day of the injection.
Age: 65.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Somnolence
Clinical narrative: Woke up extremely hot. Went to get out of bed and found my knees and legs were locked up and could not be bent. Had to shuffle while holding on to wall - or an assistant. Could not sleep after this. This condition lasted for at least 12 hours and has been slowly improving since. In addition, had "brain fog" for the whole following day and had to take several naps over the course of the day - which is not usual.  Now, four days later, I am back to about 90% of where I was the day of the injection.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: HBP confirmed that none of the patients involved have reported symptoms or adverse reactions; HBP calling to report adverse event for improperly stored and administered VARIVAX.; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      Since 07-AUG-2023, the varicella virus vaccine live (oka/merck)(VARIVAX) lot numbers W039689, X006980, W031810 and X000999 with expiration dates 13-DEC-2024, 07-MAR-2025, 05-OCT-2024 and 09-JAN-2025 respectively had a temperature excursion (product storage error) an after that, 0.5 milliliters were administered to the patient (route of administration not reported and lot number of the vaccine administered not specified) for prophylaxis. No adverse event was reported.
Sex: M
Vaccine: MMRV, VARCEL
Symptoms: Inappropriate schedule of product administration, Overdose
Clinical narrative: Nurse reported medical assistant administered PROQUAD and VARIVAX to the same patient on the same day. See request case 02477482. No additional AE/no PQC.; medical assistant administered PROQUAD and VARIVAX to the same patient on the same day.; No additional AE; This spontaneous report was received from a nurse and  refers to a 1 year old male patient. The patient's concurrent conditions, medical history, concomitant medication, drug reaction or allergies were not reported.  On an unknown date, the patient was vaccinated with one dose of varicella virus vaccine live (oka/merck)(VARIVAX) (lot # U0239723, expiration date: 15-DEC-2023) and one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # X005167, expiration date: 15-AUG-2024) (strength, frequency, route of administration, anatomical location not provided for both) on the same date (inappropriate schedule of product administration, overdose). No additional adverse event was reported.   Lot number U0239723 is an invalid lot number for varicella virus vaccine live (oka/merck)(VARIVAX)
Sex: F
Vaccine: VARZOS
Symptoms: Death, Herpes zoster, Ill-defined disorder
Clinical narrative: shingles; Other zozter -related conditions; death/wrongful death; This initial spontaneous report has been received from a lawyer regarding a case in litigation, concerning a female patient (pt) of unknown age. The pt's pertinent medical history, concurrent conditions, concomitant medications and previous drug reactions, or allergies were not reported. On 22-NOV-2012, the pt was vaccinated with the first dose of zoster vaccine live (ZOSTAVAX) subcutaneous injection (dose, strength, vaccination scheme, route of administration, anatomical location lot number and expiration date were not provided) administered for long-term prevention of shingles and zoster-related conditions. In addition, on unknown date, resulting from pt's zoster vaccine live (ZOSTAVAX) use including shingles (herpes zoster) and other zoster related conditions (ill-defined disorder), resulting in injuries to the person represented and survivorship action. In addition, it was reported that on 19-NOV-2020, the patient passed away (death). The cause of death was not reported and it was unknown if an autopsy was performed. The outcome of the events of herpes zoster and ill-defined disorder was unknown. The reporter considered all the aforementioned events to be related to zoster vaccine live (ZOSTAVAX).  The patient's death was determined to be a medically significant event.
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no adverse event; PROQUAD had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 23-AUG-2023, the patient was vaccinated with a 0.5 mL dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # X011437 exp date 18-JUL-2024) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no adverse event; PROQUAD had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 24-AUG-2023, the patient was vaccinated with a 0.5 mL dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # X011437 exp date 18-JUL-2024) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009927: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Sex: U
Vaccine: MMRV
Symptoms: Product storage error
Clinical narrative: no adverse event; PROQUAD had t/e on 16-AUG-2023 and was administered to patient; This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On 13-SEP-2023, the patient was vaccinated with a 0.5 mL dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) (lot # X011437 exp date 18-JUL-2024) (route not reported) that had a temperature excursion on 16-AUG-2023. The temperature of excursion was 25.8 °C for a time frame of 9 hours 24 minutes. There were no previous excursions. The reported also stated that the freezer units have ice packs in them that never melted during the excursion.  This is one of several reports received from the same source.; Sender's Comments:  US-009507513-2309USA006884: US-009507513-2309USA009905: US-009507513-2309USA009906: US-009507513-2309USA009907: US-009507513-2309USA009908: US-009507513-2309USA009909: US-009507513-2309USA009910: US-009507513-2309USA009911: US-009507513-2309USA009912: US-009507513-2309USA009913: US-009507513-2309USA009914: US-009507513-2309USA009915: US-009507513-2309USA009928: US-009507513-2309USA009929: US-009507513-2309USA009930:
Age: 72.0
Sex: M
Vaccine: COVID19-2
Symptoms: Diabetes mellitus, Glycosylated haemoglobin, Weight decreased
Clinical narrative: he was diagnosed with diabetes. It was pretty severe at the beginning.; This spontaneous case was reported by a physician and describes the occurrence of DIABETES MELLITUS (he was diagnosed with diabetes. It was pretty severe at the beginning.) in a 72-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 041H22A) for COVID-19 prophylaxis.     The patient's past medical history included Pancreatitis, Glucose urine present and Coronary artery bypass (Quadruple coronary artery bypasses). Concurrent medical conditions included Hypertension, Hypocholesteremia and Diabetes (He was a high risk patient).    On 16-Dec-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In February 2023, the patient experienced DIABETES MELLITUS (he was diagnosed with diabetes. It was pretty severe at the beginning.) (seriousness criterion medically significant). In 2023, DIABETES MELLITUS (he was diagnosed with diabetes. It was pretty severe at the beginning.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Glycosylated haemoglobin: His hemoglobin A1C was back to normal and he was on a minimal dose of oral hypoglycemic agents.. On an unknown date, Weight decreased: Lost 30 pounds.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. He was able to be controlled with diet and oral hypoglycemic agents. Since he went on the oral agents back in February, his diabetes has markedly recovered. Apparently he needed a lot of treatment in the beginning and his pancreas had made a recovery. Company comment- This is a regulatory authority case concerning a 72-year-old male patient with medical history of coronary artery bypass, hypertension and COVID-19 (1 month before vaccination) who experienced the unexpected and serious (medically significant) event diabetes mellitus approximately 2 months after a fifth dose of mRNA-1273 vaccine was administered. It was reported patient´s diabetes was able to be controlled with diet and oral hypoglycemic agents. Since he went on the oral agents, his diabetes has markedly recovered. Apparently, he needed a lot of treatment in the beginning and his pancreas had made a recovery. Medical history of COVID-19 remains as a contributory risk factor. The benefit-risk relationship of the mRNA-1273 vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-741615 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-741615:Same patient, Monovalent moderna vaccine
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: body aches; Shivers; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), CHILLS (Shivers), HEADACHE (Headache) and PYREXIA (Fever) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: J&J (First Primary J&J dose, Lot# & Exp. Date: unknown) on 17-Mar-2021, J&J (2nd Primary J&J dose and Lot# & Exp. Date: unknown) on 28-Oct-2021. Past adverse reactions to the above products included No adverse event with J&J and J&J.   On 16-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-May-2023, received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (body aches), CHILLS (Shivers), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, PAIN (body aches), CHILLS (Shivers), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Previously administered vaccine included for Moderna COVID-19 vaccine (Shot #3 and First Monovalent Booster dose with Lot no. 058A22A & Exp. Date unknown on 17-Jun-2022.  No concomitant medication was reported.  Reporter stated that she had her Spikevax vaccination at the same time as her husband. Her arm was okay. Inadvertently she reported that with previous vaccines, she only had shivers, headache and body aches. She would usually get shivers.  No treatment information was provided.   This case was linked to MOD-2023-742520 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: COVID-19; COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 77-year-old male patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 06Oct2022 at 09:00 as dose 5 (booster), single (Lot number: GJ3277) at the age of 76 years, in right arm for covid-19 immunisation; bnt162b2 (BNT162B2), on 29Jan2021 at 14:00 as dose 1, single (Lot number: EH8932), in right arm, on 20Feb2021 at 14:00 as dose 2, single (Lot number: EN6200), in right arm, on 16Aug2021 at 13:00 as dose 3 (booster), single (Lot number: R3181), in right arm and on 01Apr2022 at 13:00 as dose 4 (booster), single (Lot number: FJ9943), in right arm for covid-19 immunisation. The patient's relevant medical history included: "kidney cancer" (unspecified if ongoing); "known allergies penicillin" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of vaccination failure, covid-19.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Nausea
Clinical narrative: Chills, nausea, weakness, headache
Age: 19.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Asthenia, Chills, Insomnia, Muscular weakness, Nausea
Clinical narrative: Typical left arm ache and weakness starting at time of vaccination. Severe aches, nausea, and weakness starting 7.5 hours later, with more severe symptoms developing throughout the night. Was unable to sleep, with severe chills, nausea, and aches continuing until 3:30am the next day (now).  Took adult dose of Tylenol  at 8pm when symptoms arises, to no effect. Took a half dose of Tylenol and 400mg of ibuprofen at 3am with some effect. Drank water throughout the night.
Age: 19.0
Sex: M
Vaccine: COVID19, UNK
Symptoms: Pain, Pain in extremity
Clinical narrative: Typical left arm ache and weakness starting at time of vaccination. Severe aches, nausea, and weakness starting 7.5 hours later, with more severe symptoms developing throughout the night. Was unable to sleep, with severe chills, nausea, and aches continuing until 3:30am the next day (now).  Took adult dose of Tylenol  at 8pm when symptoms arises, to no effect. Took a half dose of Tylenol and 400mg of ibuprofen at 3am with some effect. Drank water throughout the night.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Fever. muscle pain, nausea; hydration, rest
Age: 68.0
Sex: F
Vaccine: COVID19, RSV
Symptoms: Dizziness, Nasal oedema, Palatal swelling, Palpitations, Pharyngeal swelling
Clinical narrative: As we were driving home, I started to have a reaction.  My nasal passages swelled, as did the roof of my mouth and throat, and I felt whoozy and my heart racing.  I quickly took a Benadryl caplet, which I had in my purse, and we turned around to go to the urgent care facility in town.  Having had an anaphylatic reaction to sulfur in the past, I was concerned that this was occurring.  At the urgent care facility, the P/A also felt this was a reaction, and administered a steroid shot, told me to continue taking Benadryl every 6 hours, and called in an RX to my pharmacy for steroids
Sex: F
Vaccine: COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: if she has COVID but is just asymptomatic; if she has COVID but is just asymptomatic; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group. The reporter is the patient.  A female patient received bnt162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "if she has COVID but is just asymptomatic". The patient wanted to know if she could take the new vaccine if she has COVID but is just asymptomatic.  The information on the batch/lot number for bnt162b2 has been requested and will be submitted if and when received.
Age: 77.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Ringing in my ears
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Arthralgia, Back pain, Blood test, Computerised tomogram, Injection site pain
Clinical narrative: Soreness at injection site,pain at left shoulder, pain at right shoulder and back of neck couple days later after vaccine.About 6 days later,in intence pain drove to hospital emergency room for treatment.After multipal tests,no results on any.About half a day  spent there.Pain did subside somewhat and was givin ibuprofin prescription.I had asked for an opiod  prescription,but Dr. said no.Pain now seems like its coming back now with new pain in lower right back.
Age: 68.0
Sex: M
Vaccine: RSV
Symptoms: Laboratory test, Neck pain, Pain, X-ray
Clinical narrative: Soreness at injection site,pain at left shoulder, pain at right shoulder and back of neck couple days later after vaccine.About 6 days later,in intence pain drove to hospital emergency room for treatment.After multipal tests,no results on any.About half a day  spent there.Pain did subside somewhat and was givin ibuprofin prescription.I had asked for an opiod  prescription,but Dr. said no.Pain now seems like its coming back now with new pain in lower right back.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Rash vesicular
Clinical narrative: Blister rash on my right inner thigh
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Atrial fibrillation, COVID-19 pneumonia, Cardiomegaly, Chest X-ray abnormal
Clinical narrative: Presented with afib with RVR, cough, dizziness, nausea, fatigue; CXR: bilat infiltrates: Dx Covid PNA, afib; TX- Remdesivir, Vit C, Rocephin, Vit D3, Decadron, Lovenox, Singulair, Zinc, Baricitinib; significant improvement and down to 4 L of NC O2 satting in the low 90s -CXR on admission showed bilateral infiltrates with cardiomegaly.  CTPE negative for PE -strep pneumo and Legionella negative -continue self proning and incentive spirometer use -completed remdesivir course. S/p 7 doses of baricitinib,  -Patient was also treated with Solu-Medrol, vitamin-C, vitamin-D, zinc, Singulair and  Flonase -s/p treatment with doxycycline and Rocephin for initial suspicion for superimposed bacterial PNA Walk test was done and patient required 1-2L of O2 with rest and 3L of NC O2 with exertion.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Computerised tomogram thorax normal, Cough, Dizziness, Fatigue, Incentive spirometry
Clinical narrative: Presented with afib with RVR, cough, dizziness, nausea, fatigue; CXR: bilat infiltrates: Dx Covid PNA, afib; TX- Remdesivir, Vit C, Rocephin, Vit D3, Decadron, Lovenox, Singulair, Zinc, Baricitinib; significant improvement and down to 4 L of NC O2 satting in the low 90s -CXR on admission showed bilateral infiltrates with cardiomegaly.  CTPE negative for PE -strep pneumo and Legionella negative -continue self proning and incentive spirometer use -completed remdesivir course. S/p 7 doses of baricitinib,  -Patient was also treated with Solu-Medrol, vitamin-C, vitamin-D, zinc, Singulair and  Flonase -s/p treatment with doxycycline and Rocephin for initial suspicion for superimposed bacterial PNA Walk test was done and patient required 1-2L of O2 with rest and 3L of NC O2 with exertion.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Legionella test, Lung infiltration, Nausea, Oxygen saturation decreased, Prone position
Clinical narrative: Presented with afib with RVR, cough, dizziness, nausea, fatigue; CXR: bilat infiltrates: Dx Covid PNA, afib; TX- Remdesivir, Vit C, Rocephin, Vit D3, Decadron, Lovenox, Singulair, Zinc, Baricitinib; significant improvement and down to 4 L of NC O2 satting in the low 90s -CXR on admission showed bilateral infiltrates with cardiomegaly.  CTPE negative for PE -strep pneumo and Legionella negative -continue self proning and incentive spirometer use -completed remdesivir course. S/p 7 doses of baricitinib,  -Patient was also treated with Solu-Medrol, vitamin-C, vitamin-D, zinc, Singulair and  Flonase -s/p treatment with doxycycline and Rocephin for initial suspicion for superimposed bacterial PNA Walk test was done and patient required 1-2L of O2 with rest and 3L of NC O2 with exertion.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Streptococcus test negative, Walking distance test abnormal
Clinical narrative: Presented with afib with RVR, cough, dizziness, nausea, fatigue; CXR: bilat infiltrates: Dx Covid PNA, afib; TX- Remdesivir, Vit C, Rocephin, Vit D3, Decadron, Lovenox, Singulair, Zinc, Baricitinib; significant improvement and down to 4 L of NC O2 satting in the low 90s -CXR on admission showed bilateral infiltrates with cardiomegaly.  CTPE negative for PE -strep pneumo and Legionella negative -continue self proning and incentive spirometer use -completed remdesivir course. S/p 7 doses of baricitinib,  -Patient was also treated with Solu-Medrol, vitamin-C, vitamin-D, zinc, Singulair and  Flonase -s/p treatment with doxycycline and Rocephin for initial suspicion for superimposed bacterial PNA Walk test was done and patient required 1-2L of O2 with rest and 3L of NC O2 with exertion.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, COVID-19 pneumonia, Chronic left ventricular failure, Condition aggravated
Clinical narrative: Presented with SOB; Covid positive.  Dx:  Covid 19 pneumonia and acute respiratory failure and also  chronic systolic heart failure exacerbation.  TX: IV diuretics, steroids was initiated on remdesevir.  He was quickly weaned off oxygen and his symptomatology was very mild in terms of Covid so remdesevir was discontinued and patient was discharged home ID in fact recommended no discharge steroids.  Patient was sent home on supportive treatments.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Diuretic therapy, Dyspnoea, SARS-CoV-2 test positive
Clinical narrative: Presented with SOB; Covid positive.  Dx:  Covid 19 pneumonia and acute respiratory failure and also  chronic systolic heart failure exacerbation.  TX: IV diuretics, steroids was initiated on remdesevir.  He was quickly weaned off oxygen and his symptomatology was very mild in terms of Covid so remdesevir was discontinued and patient was discharged home ID in fact recommended no discharge steroids.  Patient was sent home on supportive treatments.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Acute respiratory failure, Anticoagulant therapy, COVID-19 pneumonia, Chest X-ray abnormal, Dyspnoea
Clinical narrative: Presented with SOB; CXR with Covid PNA; admitted for Covid-19 pneumonia and acute hypoxemic respiratory failure. He was treated with dexamethasone, oxygen support, and supportive care (Vit C, Vit D3, Lovenox, Zinc). He improved clinically with treatment and was discharged home on day 5 in stable condition without oxygen supplement.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, COVID-19, Chronic obstructive pulmonary disease, Condition aggravated, Headache
Clinical narrative: Presented with HA; + covid; 1. Acute hypoxic respiratory failure likely secondary to COPD exacerbation due to COVID-19 viral infection:  treated with Remdesivir for 2 days but the inflamed markers are within normal limits so will discontinue Remdesivir.  tx with  steroids with tapering dose going home.  Patient feels back to her baseline almost.  Patient is clinically much improved today.  Much improved oxygenation today on room air at rest
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Inflammatory marker test, SARS-CoV-2 test positive
Clinical narrative: Presented with HA; + covid; 1. Acute hypoxic respiratory failure likely secondary to COPD exacerbation due to COVID-19 viral infection:  treated with Remdesivir for 2 days but the inflamed markers are within normal limits so will discontinue Remdesivir.  tx with  steroids with tapering dose going home.  Patient feels back to her baseline almost.  Patient is clinically much improved today.  Much improved oxygenation today on room air at rest
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Asthenia, COVID-19, Chest X-ray abnormal, Computerised tomogram thorax abnormal
Clinical narrative: Presented with SOB/fatigue, weaknss; + covid PTA; CXR- PNA; CT: no PE, + multifocal PNA; Tx Levaquin, zithromax, Vit D3, Decadron, Lovenox, Zinc; mildly hypoxic and so she was placed on supplemental oxygen; mildly hypoxic and so she was placed on supplemental oxygen. Patient dropped O2 saturations with Walk study. Home oxygen has been arranged for patient
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fatigue, Hypoxia, Oxygen saturation decreased, Pneumonia
Clinical narrative: Presented with SOB/fatigue, weaknss; + covid PTA; CXR- PNA; CT: no PE, + multifocal PNA; Tx Levaquin, zithromax, Vit D3, Decadron, Lovenox, Zinc; mildly hypoxic and so she was placed on supplemental oxygen; mildly hypoxic and so she was placed on supplemental oxygen. Patient dropped O2 saturations with Walk study. Home oxygen has been arranged for patient
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Walking distance test abnormal
Clinical narrative: Presented with SOB/fatigue, weaknss; + covid PTA; CXR- PNA; CT: no PE, + multifocal PNA; Tx Levaquin, zithromax, Vit D3, Decadron, Lovenox, Zinc; mildly hypoxic and so she was placed on supplemental oxygen; mildly hypoxic and so she was placed on supplemental oxygen. Patient dropped O2 saturations with Walk study. Home oxygen has been arranged for patient
Age: 39.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus in left ear. Mild but notable and no prior issues
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Chest X-ray abnormal, Cough, Dyspnoea, Positive airway pressure therapy
Clinical narrative: Presented with SOB, cough, fever onset 11/8; CXR: possible infiltrates; Tx: Maxipime, decadron, Vit D3, Doxycycline, lovenox, initially on NRB/bipap for supplemental O2; weaned to 3 LPM by d/c
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Presented with SOB, cough, fever onset 11/8; CXR: possible infiltrates; Tx: Maxipime, decadron, Vit D3, Doxycycline, lovenox, initially on NRB/bipap for supplemental O2; weaned to 3 LPM by d/c
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Bradycardia, C-reactive protein increased, COVID-19, COVID-19 pneumonia, Chest X-ray abnormal
Clinical narrative: Presented wtih SOB/hypoxia; + covid PTA; Dx Covid PNA; CXR: interstitial markings in lung bases d/t pul congestion or interstitial pneumonitis; Labs: D-dimer: 1.33 CRP 9.85 Ferritin 407; TX: Zithromax, Maxipime, remdesivir (1 dose) decadron, Singulair, zinc; FiO2 up to 5 LPM NC and then weaned to 2 LPM NC at D/C She was placed on dexamethasone and later Remdesivir added however due to worsening bradycardia it was stopped. She improved on steroids and once medically stable and at baseline she was discharged back to her facility.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Fibrin D dimer, Hypoxia, Interstitial lung disease, Pulmonary congestion
Clinical narrative: Presented wtih SOB/hypoxia; + covid PTA; Dx Covid PNA; CXR: interstitial markings in lung bases d/t pul congestion or interstitial pneumonitis; Labs: D-dimer: 1.33 CRP 9.85 Ferritin 407; TX: Zithromax, Maxipime, remdesivir (1 dose) decadron, Singulair, zinc; FiO2 up to 5 LPM NC and then weaned to 2 LPM NC at D/C She was placed on dexamethasone and later Remdesivir added however due to worsening bradycardia it was stopped. She improved on steroids and once medically stable and at baseline she was discharged back to her facility.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Serum ferritin increased
Clinical narrative: Presented wtih SOB/hypoxia; + covid PTA; Dx Covid PNA; CXR: interstitial markings in lung bases d/t pul congestion or interstitial pneumonitis; Labs: D-dimer: 1.33 CRP 9.85 Ferritin 407; TX: Zithromax, Maxipime, remdesivir (1 dose) decadron, Singulair, zinc; FiO2 up to 5 LPM NC and then weaned to 2 LPM NC at D/C She was placed on dexamethasone and later Remdesivir added however due to worsening bradycardia it was stopped. She improved on steroids and once medically stable and at baseline she was discharged back to her facility.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture negative, COVID-19, Computerised tomogram thorax normal, Cough, Diabetic ketoacidosis
Clinical narrative: Pressented with SOB; cough; dx: DKA, Covid infection; CT negative for PE but showing bilateral dependent lower lobe airspace disease-DC on empiric antibiotics with concern for aspiration -dexamethasone discontinued as patient is on room air and given DKA, rec'd zinc -infectious Disease consulted.  Blood cultures negative thus far, respiratory culture pending.  Urine antigens negative - inflammatory markers are being monitored and are improving
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Inflammatory marker test, Lung disorder, Sputum culture, Urine analysis normal
Clinical narrative: Pressented with SOB; cough; dx: DKA, Covid infection; CT negative for PE but showing bilateral dependent lower lobe airspace disease-DC on empiric antibiotics with concern for aspiration -dexamethasone discontinued as patient is on room air and given DKA, rec'd zinc -infectious Disease consulted.  Blood cultures negative thus far, respiratory culture pending.  Urine antigens negative - inflammatory markers are being monitored and are improving
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Anticoagulant therapy, Aspiration, Atelectasis, C-reactive protein increased, COVID-19
Clinical narrative: Presented with AMS, + covid 11/1; CXR "bibasilar airspace disease left greater than right that is nonspecific and may be related to atelectasis, pna, and/or aspiration"; CT chest with PE, no severe Covid PNA;  Labs: D-dimer 17.06; CRP 24.92; Ferritin 982.9 Tx: maxipime, solu-medrol, redesivir, vancomycin, lovenox; He was hypoxic in the ED 92% on RA and started on on 4 LNC,  also had MRSA bacteremia, on high risk antibiotics,  dysphagia, treated with dobhoff tube ,  pulmonary embolus treated with therapeutic lovenox.On the night of 11/21/21, he vomited blood and aspirated, had low blood pressure, low oxygen saturation in spite of HFNC 100%, and was imminent. He was supported with IV fluids, prbc transfusion, IV ppi gtt, supplemental oxygen, but failed to improve. His wife decided to change to complete DNR. He passed at 1939.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19 pneumonia, Chest X-ray abnormal, Computerised tomogram thorax abnormal, Death, Dysphagia
Clinical narrative: Presented with AMS, + covid 11/1; CXR "bibasilar airspace disease left greater than right that is nonspecific and may be related to atelectasis, pna, and/or aspiration"; CT chest with PE, no severe Covid PNA;  Labs: D-dimer 17.06; CRP 24.92; Ferritin 982.9 Tx: maxipime, solu-medrol, redesivir, vancomycin, lovenox; He was hypoxic in the ED 92% on RA and started on on 4 LNC,  also had MRSA bacteremia, on high risk antibiotics,  dysphagia, treated with dobhoff tube ,  pulmonary embolus treated with therapeutic lovenox.On the night of 11/21/21, he vomited blood and aspirated, had low blood pressure, low oxygen saturation in spite of HFNC 100%, and was imminent. He was supported with IV fluids, prbc transfusion, IV ppi gtt, supplemental oxygen, but failed to improve. His wife decided to change to complete DNR. He passed at 1939.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Fibrin D dimer, Gastrointestinal tube insertion, Haematemesis, Hypotension, Hypoxia
Clinical narrative: Presented with AMS, + covid 11/1; CXR "bibasilar airspace disease left greater than right that is nonspecific and may be related to atelectasis, pna, and/or aspiration"; CT chest with PE, no severe Covid PNA;  Labs: D-dimer 17.06; CRP 24.92; Ferritin 982.9 Tx: maxipime, solu-medrol, redesivir, vancomycin, lovenox; He was hypoxic in the ED 92% on RA and started on on 4 LNC,  also had MRSA bacteremia, on high risk antibiotics,  dysphagia, treated with dobhoff tube ,  pulmonary embolus treated with therapeutic lovenox.On the night of 11/21/21, he vomited blood and aspirated, had low blood pressure, low oxygen saturation in spite of HFNC 100%, and was imminent. He was supported with IV fluids, prbc transfusion, IV ppi gtt, supplemental oxygen, but failed to improve. His wife decided to change to complete DNR. He passed at 1939.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Lung disorder, Mental status changes, Oxygen saturation decreased, Pulmonary embolism, Red blood cell transfusion
Clinical narrative: Presented with AMS, + covid 11/1; CXR "bibasilar airspace disease left greater than right that is nonspecific and may be related to atelectasis, pna, and/or aspiration"; CT chest with PE, no severe Covid PNA;  Labs: D-dimer 17.06; CRP 24.92; Ferritin 982.9 Tx: maxipime, solu-medrol, redesivir, vancomycin, lovenox; He was hypoxic in the ED 92% on RA and started on on 4 LNC,  also had MRSA bacteremia, on high risk antibiotics,  dysphagia, treated with dobhoff tube ,  pulmonary embolus treated with therapeutic lovenox.On the night of 11/21/21, he vomited blood and aspirated, had low blood pressure, low oxygen saturation in spite of HFNC 100%, and was imminent. He was supported with IV fluids, prbc transfusion, IV ppi gtt, supplemental oxygen, but failed to improve. His wife decided to change to complete DNR. He passed at 1939.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive, Serum ferritin increased, Staphylococcal bacteraemia
Clinical narrative: Presented with AMS, + covid 11/1; CXR "bibasilar airspace disease left greater than right that is nonspecific and may be related to atelectasis, pna, and/or aspiration"; CT chest with PE, no severe Covid PNA;  Labs: D-dimer 17.06; CRP 24.92; Ferritin 982.9 Tx: maxipime, solu-medrol, redesivir, vancomycin, lovenox; He was hypoxic in the ED 92% on RA and started on on 4 LNC,  also had MRSA bacteremia, on high risk antibiotics,  dysphagia, treated with dobhoff tube ,  pulmonary embolus treated with therapeutic lovenox.On the night of 11/21/21, he vomited blood and aspirated, had low blood pressure, low oxygen saturation in spite of HFNC 100%, and was imminent. He was supported with IV fluids, prbc transfusion, IV ppi gtt, supplemental oxygen, but failed to improve. His wife decided to change to complete DNR. He passed at 1939.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest X-ray abnormal, Dyspnoea, Pulmonary congestion, Total lung capacity decreased
Clinical narrative: Presented with weakness/SOB x3 days; CXR: "low lung volumes with central congestion"; no inflammation lab values drawn;  placed on supplemental oxygen, zinc and steroids. He was initiated on remdesivir by Dr. He tolerated this very well and was able to wean quickly to room air
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysphonia, Laryngitis
Clinical narrative: Hoarseness/Laryngitis with no other symptoms that would normally accompany hoarseness/laryngitis. i.e. no cold symptoms prior or current, no drainage, no nasal congestion, no sneezing.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse event; Caller reported AE on behalf of a patient who was administered improperly stored PROQUAD. No symptoms reported. Obtained consent to contact HCP. No additional AE/PQC. Product Name: PROQUAD-- SUPPORTED Lot: X014622 Exp: 11/1; This spontaneous report was received from a nurse concerning to a patient of unknown age and gender. Information about historical condition and concomitant medication was not reported.  On 18-SEP-2023, the patient was vaccinated with improperly stored of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (rHA) (PROQUAD), 0.5 ml, lot # X014622 with an expiration date of 18-NOV-2024, as prophylaxis (strength, dose, anatomical location, route of administration, were not reported) (Product storage error).   There wa as temperature excursion for measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD). The temperature was -14 degrees Celsius up to -10 degree Celsius for 4 hours 15 minutes and -8.33 degree Celsius up to 8 degree Celsius for 7 hours 45 minutes. The time frame was 12 hours. There was no previous temperature excursion. No symptoms reported and no addtional adverse event nor product quality complaint.
Age: 6.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No additional AE/no PQC.; Medical assistant reported GARDASIL 9 was accidentally administered to a 6-year-old patient.; This spontaneous report was received from a medical assistant and refers to a 6-year-old male patient. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 28-SEP-2023, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, first dose, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided) (Inappropriate age at vaccine administration). No additional adverse event was reported.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP confirmed that their practice has not received any reports of a patient involved having any symptoms or medical concerns/ no additional AE/PQC reported; patient inadvertently administered an expired dose of MMR II; This spontaneous report has been received from a healthcare business professional and refers to an 18-month-old patient of unknown gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 27-SEP-2023, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, at a  dose of 0.5 milliliter (ml) (expired product administered) (lot number U029789 has been determined to be valid for measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), with an expiration date established as 23-SEP-2023), administered for prophylaxis (strength, and route of administration were not provided). The reporter confirmed that their practice had not received any report of the patient having experienced any adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Macular degeneration, Pain, Vaccination failure
Clinical narrative: AMD in right eye; shingles on the top of head/Suspected vaccination failure; shingles on the top of head; Painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of macular degeneration in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had it years ago so painful).   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced macular degeneration (Verbatim: AMD in right eye) (serious criteria GSK medically significant), vaccination failure (Verbatim: shingles on the top of head/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles on the top of head) and pain (Verbatim: Painful).  The outcome of the macular degeneration, shingles and pain were not reported and the outcome of the vaccination failure was unknown.   The reporter considered the macular degeneration, vaccination failure, shingles and pain to be possibly related to Shingrix.     The company considered the macular degeneration, vaccination failure, shingles and pain to be possibly related to Shingrix.   Additional Information: GSK receipt date: 21-SEP-2023 This case was reported the patient via interactive digital media. The reporter felt sorry for the pain. The reporter had that years ago was painful and got shot as they said would probably protect her. The patient got that again in hair top of head and used electric rickets, thought burned the head so painful, stopped at health center and they said lot sure not it was on fact snf like shied going to eye. The patient was asked to visit the specialist and the patient visited, was alarmed and helped her and told her what was going through. The specialist told of having AMD in right eye. The reporter had been getting shot in bad eye, asked for being careful and did not mess around with the virus. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up not possible as no contact details provided.
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain
Clinical narrative: Blistering; Very painful; This non-serious case was reported by a consumer and described the occurrence of blister in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included progesterone.   On 15-SEP-2023, the patient received Shingrix. On 17-SEP-2023, 2 days after receiving Shingrix, the patient experienced blister (Verbatim: Blistering) and pain (Verbatim: Very painful).  The outcome of the blister was resolving and the outcome of the pain was not reported.   It was unknown if the reporter considered the blister and pain to be related to Shingrix.     It was unknown if the company considered the blister and pain to be related to Shingrix.   Additional Information: GSK receipt date 23 Sep 2023 The patient reported that it was very painful and she would not be getting second vaccine The patient also had blistering. The symptoms were treated. Permission to contact was given.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: recurring shingles/outbreak on my arm and around my stomach; This non-serious case was reported by a consumer and described the occurrence of shingles in a 57-year-old male patient who received Herpes zoster (Shingles vaccine) (batch number 58160-0823-11, expiry date 23-SEP-2023) for prophylaxis.   The patient's past medical history included shingles.   On 20-SEP-2023, the patient received the 1st dose of Shingles vaccine. On 21-SEP-2023, 1 days after receiving Shingles vaccine, the patient experienced shingles (Verbatim: recurring shingles/outbreak on my arm and around my stomach).  The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 24-SEP-2023 The patient self-reported this case. The patient took the vaccine before the 6 months was up for his recurring shingles was abated. The patient recovered from shingles in May 2023.  The patient now had the outbreaks on his arm and around stomach (at the time of reporting). The patient asked if it is dangerous to have gotten the vaccine before he was completely over the virus (recurring shingles). The symptoms were not treated. The reporter gave permission to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Immunisation reaction
Clinical narrative: Experienced local reactogenicity; This non-serious case was reported by a pharmacist and described the occurrence of reactogenicity event in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (unknown arm). On an unknown date, an unknown time after receiving Shingrix, the patient experienced reactogenicity event (Verbatim: Experienced local reactogenicity).  The outcome of the reactogenicity event was not reported.   The reporter considered the reactogenicity event to be related to Shingrix.     The company considered the reactogenicity event to be related to Shingrix.   Additional Information: GSK Receipt Date: 23-SEP-2023 The patient age was reported as 6 decades. The reporter reported that the patient mentioned receiving Shingrix and experienced local reactogenicity. The reporter had no additional information except that this person casually mentioned local reactogenicity.
Sex: F
Vaccine: TDAP
Symptoms: Immunisation reaction
Clinical narrative: she experienced local reactogenicity; This non-serious case was reported by a pharmacist via sales rep and described the occurrence of reactogenicity event in a adult female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix (unknown arm). On an unknown date, an unknown time after receiving Boostrix, the patient experienced reactogenicity event (Verbatim: she experienced local reactogenicity). The outcome of the reactogenicity event was not reported.   The reporter considered the reactogenicity event to be related to Boostrix.     The company considered the reactogenicity event to be related to Boostrix.   Additional Information: GSK Receipt Date: 23-SEP-2023 The age of the patient was reported as 5 decades. The reporter reported that the patient mentioned receiving Boostrix and experienced local reactogenicity. The reporter consented to follow up.