chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 73.0
Sex: F
Vaccine: FLU4, FLUA4
Symptoms: Respiratory distress
Clinical narrative: Respiratory Distress; This spontaneous case was retrieved on 05-Dec-2023 from the Vaccine Adverse Event Reporting System (VAERS) (reference number: 2706537-1), reported by other healthcare professional and concerned a 73-year-old, female patient.  The patient's concurrent conditions included adult failure to thrive, allergy to alprazolam and meperidine, increased white blood cells (WBC) and chronic obstructive pulmonary disease (COPD) exacerbation per chest x-ray. The patient's concomitant medications included amlodipine, ferrous sulfate, Fosamax (alendronate sodium) all used for unspecified indication, and Z-pak (azithromycin) used for increased WBC and COPD exacerbation.  It was reported that on 29-Oct-2023, the patient was vaccinated with Afluria Quadrivalent, (influenza vaccine inact split 4v; dose: reported as '1'; route of administration: intramuscular; anatomical location: right arm; indication: not reported). The batch number reported was 371609. The reported batch number was identified by Seqirus to be linked to suspect product Fluad Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect product Afluria Quadrivalent. Based on the reported batch number, the suspect product was changed to Fluad Quadrivalent.  On 30-Oct-2023, one day after receiving the Fluad Quadrivalent, the patient experienced respiratory distress, and was sent to the emergency department (ED). Blood culture, complete blood count, basic metabolic panel, and procalcitonin were obtained, and the results were pending. No further information was provided.  The outcome of the event was unknown.  The reporter did not provide a causality assessment.  The event of respiratory distress was considered to be medically significant by Physician within Seqirus's Regulatory Authority.  Company comment: A patient was vaccinated with Fluad Quadrivalent. One day after vaccination, the patient experienced respiratory distress. Blood culture, complete blood count, basic metabolic panel, and procalcitonin were obtained, and the results were pending. No further information was provided. The patient's underlying chronic obstructive pulmonary disease exacerbation, highly confounds causality. Nevertheless, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the event respiratory distress, with the currently available information and chronological plausibility.; Sender's Comments: A patient was vaccinated with Fluad Quadrivalent. One day after vaccination, the patient experienced respiratory distress. Blood culture, complete blood count, basic metabolic panel, and procalcitonin were obtained, and the results were pending. No further information was provided. The patient's underlying chronic obstructive pulmonary disease exacerbation, highly confounds causality. Nevertheless, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the event respiratory distress, with the currently available information and chronological plausibility.
Age: 73.0
Sex: F
Vaccine: FLU4, FLUA4
Symptoms: Blood culture, Full blood count, Metabolic function test, Procalcitonin, Respiratory distress
Clinical narrative: Respiratory Distress; This spontaneous case was retrieved on 05-Dec-2023 from the Vaccine Adverse Event Reporting System (VAERS) (reference number: 2706537-1), reported by other healthcare professional and concerned a 73-year-old, female patient.  The patient's concurrent conditions included adult failure to thrive, allergy to alprazolam and meperidine, increased white blood cells (WBC) and chronic obstructive pulmonary disease (COPD) exacerbation per chest x-ray. The patient's concomitant medications included amlodipine, ferrous sulfate, Fosamax (alendronate sodium) all used for unspecified indication, and Z-pak (azithromycin) used for increased WBC and COPD exacerbation.  It was reported that on 29-Oct-2023, the patient was vaccinated with Afluria Quadrivalent, (influenza vaccine inact split 4v; dose: reported as '1'; route of administration: intramuscular; anatomical location: right arm; indication: not reported). The batch number reported was 371609. The reported batch number was identified by Seqirus to be linked to suspect product Fluad Quadrivalent (influenza vaccine inact sag 4v) instead of reported suspect product Afluria Quadrivalent. Based on the reported batch number, the suspect product was changed to Fluad Quadrivalent.  On 30-Oct-2023, one day after receiving the Fluad Quadrivalent, the patient experienced respiratory distress, and was sent to the emergency department (ED). Blood culture, complete blood count, basic metabolic panel, and procalcitonin were obtained, and the results were pending. No further information was provided.  The outcome of the event was unknown.  The reporter did not provide a causality assessment.  The event of respiratory distress was considered to be medically significant by Physician within Seqirus's Regulatory Authority.  Company comment: A patient was vaccinated with Fluad Quadrivalent. One day after vaccination, the patient experienced respiratory distress. Blood culture, complete blood count, basic metabolic panel, and procalcitonin were obtained, and the results were pending. No further information was provided. The patient's underlying chronic obstructive pulmonary disease exacerbation, highly confounds causality. Nevertheless, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the event respiratory distress, with the currently available information and chronological plausibility.; Sender's Comments: A patient was vaccinated with Fluad Quadrivalent. One day after vaccination, the patient experienced respiratory distress. Blood culture, complete blood count, basic metabolic panel, and procalcitonin were obtained, and the results were pending. No further information was provided. The patient's underlying chronic obstructive pulmonary disease exacerbation, highly confounds causality. Nevertheless, causal role of the suspect vaccine cannot be excluded and is assessed as possibly related for the event respiratory distress, with the currently available information and chronological plausibility.
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Loss of personal independence in daily activities, Pain
Clinical narrative: Pt reported frozen shoulder after vaccine administration on 10/30/2023
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Product administered at inappropriate site, X-ray limb normal
Clinical narrative: Pt reported frozen shoulder after vaccine administration on 10/30/2023
Age: 53.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Periarthritis
Clinical narrative: Pt reported frozen shoulder after vaccine administration on 10/30/2023
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Dyspnoea
Clinical narrative: CHEST PAIN; TROUBLE BREATHING; This spontaneous report received from an attorney and company representative: Documents were received in the form of Legal Summons and Complaints (SAC) and EZR document. This report concerned a 23 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic asthma. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose not reported administered in NOV-2021 as a prophylactic vaccination. Batch number was not reported. We are unable to make the follow up to request batch number. No concomitant medications were reported. The patient was mandated and coerced to take the vaccine in NOV-2021 shortly before his death. Patient was in good health, and his chronic asthma, which he had since childhood, was well managed. On the afternoon 25-NOV-2021 (Thanksgiving day), the patient presented to the emergency room with chest pain and shortness of breath. Patient was evaluated and discharged from the emergency room. Several hours later, however, patient had to return to the emergency room because he was in great distress and having trouble breathing. Patient received treatment on his second visit to the emergency room, but it was too little, too late. The patient passed away (wrongful death) on 25-NOV-2021 in the emergency room. Vaccine was severally liable for this coercion, which resulted in patient's premature death at the age of 23. It was not reported that if an autopsy was performed.  The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient died of chest pain and trouble breathing. This report was serious (Death).; Sender's Comments: Medical assessment comment not required per standard procedure as this is a legal case.; Reported Cause(s) of Death: CHEST PAIN; TROUBLE BREATHING
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chest pain, Death, Dyspnoea, Respiratory distress
Clinical narrative: CHEST PAIN; TROUBLE BREATHING; This spontaneous report received from an attorney and company representative: Documents were received in the form of Legal Summons and Complaints (SAC) and EZR document. This report concerned a 23 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic asthma. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number was not reported) dose not reported administered in NOV-2021 as a prophylactic vaccination. Batch number was not reported. We are unable to make the follow up to request batch number. No concomitant medications were reported. The patient was mandated and coerced to take the vaccine in NOV-2021 shortly before his death. Patient was in good health, and his chronic asthma, which he had since childhood, was well managed. On the afternoon 25-NOV-2021 (Thanksgiving day), the patient presented to the emergency room with chest pain and shortness of breath. Patient was evaluated and discharged from the emergency room. Several hours later, however, patient had to return to the emergency room because he was in great distress and having trouble breathing. Patient received treatment on his second visit to the emergency room, but it was too little, too late. The patient passed away (wrongful death) on 25-NOV-2021 in the emergency room. Vaccine was severally liable for this coercion, which resulted in patient's premature death at the age of 23. It was not reported that if an autopsy was performed.  The action taken with COVID-19 vaccine ad26.cov2.s was not applicable. The patient died of chest pain and trouble breathing. This report was serious (Death).; Sender's Comments: Medical assessment comment not required per standard procedure as this is a legal case.; Reported Cause(s) of Death: CHEST PAIN; TROUBLE BREATHING
Sex: F
Vaccine: HEP, UNK
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: extra dose administered; Inappropriate schedule of vaccine administered; Inappropriate schedule of vaccine administered; This spontaneous report has been received from a healthcare provider, via medical records from a case in litigation for Quadrivalent Human Papillomavirus (Types 6,11,16,18) Recomb. Vaccine (GARDASIL) (MARRS #2310USA002509), concerning a 8-weeks old female patient. The patient's medical history, concurrent conditions, and concomitant medications were not provided.   On 02-FEB-2005, the patient was vaccinated with Hepatitis B Vaccine (Recombinant) (manufacturer unknown) intramuscular injection as prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number, and expiration date were not provided). Consequently, on 14-MAR-2005, the patient received a dose of hepatitis b vaccine  (+), hib vaccine (HAEMOPHILUS INFLUENZA B AND HEPATITIS B VACC.) (inappropriate schedule of product administration) (strength, dose, route of administration, anatomical location, lot number, and expiration date were not provided), and additional doses of Hepatitis B Vaccine (Recombinant) (manufacturer unknown) on 21-NOV-2005 (inappropriate schedule of product administration), and 22-NOV-2005 (extra dose administered).; Sender's Comments:  US-009507513-2310USA002509:MSD
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: patent received the first dose of Shingrix 3 or 4 years ago.; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received the first dose of Shingrix 3 or 4 years ago).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: patent received the first dose of Shingrix 3 or 4 years ago.). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 07-DEC-2023 Reporter wanted to know if the patient needed to restart the vaccine series. However, the reporter did not provide information about the first dose given.  Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. During the call permission to follow up was not requested.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Hypertension, Laboratory test, Transient ischaemic attack
Clinical narrative: had TIA 9 days after shot had every test all negative something spiked my blood pressure to 189 over 105; had TIA 9 days after shot had every test all negative something spiked my blood pressure to 189 over 105; This spontaneous case was reported by a patient and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (had TIA 9 days after shot had every test all negative something spiked my blood pressure to 189 over 105) in an elderly patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced TRANSIENT ISCHAEMIC ATTACK (had TIA 9 days after shot had every test all negative something spiked my blood pressure to 189 over 105) (seriousness criterion medically significant) and HYPERTENSION (had TIA 9 days after shot had every test all negative something spiked my blood pressure to 189 over 105). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (had TIA 9 days after shot had every test all negative something spiked my blood pressure to 189 over 105) and HYPERTENSION (had TIA 9 days after shot had every test all negative something spiked my blood pressure to 189 over 105) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 189 over 105. On an unknown date, Laboratory test: (Negative) after shot had every test all negative.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  Patient's age was over 65. Patient had TIA 9 days after shot had every test all negative. It was reported that something was spiked that the blood pressure was 189 over 105.  Treatment information was not reported.  Company Comment This spontaneous case concerns an elderly patient of an unknown gender with no medical history reported who experienced the unexpected medically significant AESI of transient ischaemic attack; and the unexpected event of hypertension  unknown days after 5th. dose of mRNA-1273.815 vaccine. At the time of the report, the outcome of the events was unknown.  Concomitant medication nor Treatment details were reported. The benefit-risk relationship of mRNA-1273.815  vaccine is not affected by this report.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal distension, Anticoagulant therapy, Brain death, Coma, Death
Clinical narrative: Around Mid-May, 12-13th.  Patient started not to feel well. Tired, stomach was a little bloated, a litttle dizzy.  He said he felt he was getting a cold.  End of May beginning of June, his syptoms had not gone away.  He was bloated, had cramping in legs and tired.  End of june he had sharp pains in ribs, thought he pulled a muscle.July 5 he was so dizzy he thought he was going to pass out, coldnt walk up the stairs.  Called 911 and they took him to ER.  He had submassive plumary Embolis, doctor believed it was from Janssen vaccine, gave him heparin and 45 seconds later he had a heart attack and died right in front of me in the ER.  After 40 minutes of CPR he had a heart beat but was in non-induced coma.  July 11th I had his breathing tube removed because he was brain dead.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Endotracheal intubation, Fatigue, Gait disturbance, Immunisation reaction
Clinical narrative: Around Mid-May, 12-13th.  Patient started not to feel well. Tired, stomach was a little bloated, a litttle dizzy.  He said he felt he was getting a cold.  End of May beginning of June, his syptoms had not gone away.  He was bloated, had cramping in legs and tired.  End of june he had sharp pains in ribs, thought he pulled a muscle.July 5 he was so dizzy he thought he was going to pass out, coldnt walk up the stairs.  Called 911 and they took him to ER.  He had submassive plumary Embolis, doctor believed it was from Janssen vaccine, gave him heparin and 45 seconds later he had a heart attack and died right in front of me in the ER.  After 40 minutes of CPR he had a heart beat but was in non-induced coma.  July 11th I had his breathing tube removed because he was brain dead.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Muscle spasms, Musculoskeletal chest pain, Myocardial infarction, Nasopharyngitis
Clinical narrative: Around Mid-May, 12-13th.  Patient started not to feel well. Tired, stomach was a little bloated, a litttle dizzy.  He said he felt he was getting a cold.  End of May beginning of June, his syptoms had not gone away.  He was bloated, had cramping in legs and tired.  End of june he had sharp pains in ribs, thought he pulled a muscle.July 5 he was so dizzy he thought he was going to pass out, coldnt walk up the stairs.  Called 911 and they took him to ER.  He had submassive plumary Embolis, doctor believed it was from Janssen vaccine, gave him heparin and 45 seconds later he had a heart attack and died right in front of me in the ER.  After 40 minutes of CPR he had a heart beat but was in non-induced coma.  July 11th I had his breathing tube removed because he was brain dead.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pulmonary embolism, Resuscitation
Clinical narrative: Around Mid-May, 12-13th.  Patient started not to feel well. Tired, stomach was a little bloated, a litttle dizzy.  He said he felt he was getting a cold.  End of May beginning of June, his syptoms had not gone away.  He was bloated, had cramping in legs and tired.  End of june he had sharp pains in ribs, thought he pulled a muscle.July 5 he was so dizzy he thought he was going to pass out, coldnt walk up the stairs.  Called 911 and they took him to ER.  He had submassive plumary Embolis, doctor believed it was from Janssen vaccine, gave him heparin and 45 seconds later he had a heart attack and died right in front of me in the ER.  After 40 minutes of CPR he had a heart beat but was in non-induced coma.  July 11th I had his breathing tube removed because he was brain dead.
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Headache, Inappropriate schedule of product administration
Clinical narrative: I am 21 weeks pregnant as of today?s date. I was offered the RSV vaccine at 16 weeks gestation but waited until I was further along. My estimated due date is April 25, 2024. Approximately 3 hours after I received the vaccine, I got a headache. It evolved over the next 24 hours to a mild to severe positional headache. I?m planning to go to an emergency room in the AM if it hasn?t resolved by the time I wake up. This ranks as the most painful headache I?ve ever had.
Age: 15.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No signs/symptoms of adverse reactions had been reported.; PROQUAD had accidentally been administered to a 15-year-old patient.; This spontaneous report has been received from a medical assistant and refers to a 15-year-old patient of unknown gender. Information regarding the patient's pertinent medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was not provided.  On 13-NOV-2023, the patient was accidentally vaccinated with a first dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live recombinant Human albumin (rHA) (PROQUAD) injection as prophylaxis, lot number x013910 has been verified to be valid, expiration date 10-NOV-2024 (dose, route of administration and anatomical location of vaccination were not provided) (product administered to patient of inappropriate age). No signs or symptoms of adverse reactions had been reported.
Sex: M
Vaccine: RSV
Symptoms: Malaise
Clinical narrative: feeling not "well'; This non-serious case was reported by a nurse via sales rep and described the occurrence of feeling unwell in a 67-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 01-DEC-2023, the patient received Arexvy. In DEC-2023, an unknown time after receiving Arexvy, the patient experienced feeling unwell (Verbatim: feeling not "well'). In DEC-2023, the outcome of the feeling unwell was resolved (duration 4 days).   It was unknown if the reporter considered the feeling unwell to be related to Arexvy.     It was unknown if the company considered the feeling unwell to be related to Arexvy.   Additional Information: GSK Receipt Date - 06-DEC-2023 The nurse reported that patient got Arexvy injection vaccine and stated that feeling not 'well' for four days following the injection. The reporter reported that no specifics were given about the type of symptoms the patient experienced. The reporter did not consent to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: The patient got Covid-19 in November 2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (The patient got Covid-19 in November 2022) in an elderly female patient who received mRNA-1273 (Spikevax) (batch no. 056A22A) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 and Liver transplant in 2007. Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (Dose 1, Lot No. 011M20A, Anatomical location: Left Arm) on 10-Feb-2021, Moderna COVID-19 Vaccine (Dose 2, Lot No. 040A211A, Anatomical location: Left arm) on 11-Mar-2021, Moderna COVID-19 Vaccine (Dose 3, Lot no. 052E21A and Anatomical location: Left Arm) on 22-Oct-2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine, Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine. Concurrent medical conditions included Immunocompromised (Patient is immunocompromised due to a liver transplant in 2007). Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication.    On 15-Apr-2022, the patient received fourth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. In November 2022, the patient experienced COVID-19 (The patient got Covid-19 in November 2022). At the time of the report, COVID-19 (The patient got Covid-19 in November 2022) had resolved.            Treatment medications was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 11-Dec-2023: Live follow-up received that contains significant information: Reference updated. On 11-Dec-2023: Live follow-up received that contains significant information: Patient's medical history was added, event outcome was updated from unknown to recovered. Reference added.
Sex: F
Vaccine: COVID19
Symptoms: Lymphoma
Clinical narrative: lymphoma/Lymph gland enlargement; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (lymphoma/Lymph gland enlargement) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) (batch no. 80777-0287-92) for COVID-19 prophylaxis.     No Medical History information was reported.    On 15-Dec-2021, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. In 2022, the patient experienced LYMPHOMA (lymphoma/Lymph gland enlargement) (seriousness criterion medically significant). At the time of the report, LYMPHOMA (lymphoma/Lymph gland enlargement) had not resolved.            Concomitant and treatment medications were not reported.  Company Comment: This is a spontaneous case concerning an adult female patient, with no reported medical history, who experienced the unexpected and serious (due to medically significant) event of Lymphoma, which occurred within the first year after an unspecified dose of SPIKEVAX NOS vaccine. As reported, patient experienced lymph gland enlargement. No information disclosed about diagnostic tests performed or treatments received. At the time of the report, the event had not resolved. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.
Age: 38.0
Sex: M
Vaccine: COVID19
Symptoms: Colitis ulcerative, Diarrhoea haemorrhagic
Clinical narrative: Within a few days of getting that first dose I started experience diarrhea which lasted for weeks and contained blood.
Age: 3.0
Sex: M
Vaccine: HEPA, PNC20
Symptoms: Wrong product administered
Clinical narrative: wrong immunization given
Age: 3.0
Sex: M
Vaccine: DTAPIPV, HEPA, PNC13
Symptoms: Wrong product administered
Clinical narrative: MMR given, MMRV ordered
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: MMR given, MMRV ordered
Sex: M
Vaccine: COVID19
Symptoms: Acute febrile neutrophilic dermatosis, Biopsy skin, Biopsy skin abnormal, Neutrophilic dermatosis, Pneumonia staphylococcal
Clinical narrative: Patient had received the Pfizer Covid-19 vaccine for all of his previous doses with no issues. He received a Moderna vaccine outpatient on Wed 10/25/23 (patient reported date) and then developed flank/tongue/extremity ulceration without the presence of bacterial, fungal, or viral features. He was diagnosed with Sweet Syndrome secondary to receiving the Moderna Covid-19 vaccine, diagnosis of exclusion. He was also found to have methicillin-resistant Staphylococcus aureus pneumonia via culture of expectorated sputum on 10/31/23. He was treated with ampicillin-sulbactam 10/30/23-11/3/23; clindamycin 11/3/23-11/7/23; doxycycline, piperacillin-tazobactam, and linezolid 11/7/23-11/13/23; and prednisone 11/9/23-current (60 mg 11/9-11/17, 40 mg 11/18-current, planning for a taper).
Sex: M
Vaccine: COVID19
Symptoms: Productive cough, Skin ulcer, Sputum culture positive, Tongue ulceration
Clinical narrative: Patient had received the Pfizer Covid-19 vaccine for all of his previous doses with no issues. He received a Moderna vaccine outpatient on Wed 10/25/23 (patient reported date) and then developed flank/tongue/extremity ulceration without the presence of bacterial, fungal, or viral features. He was diagnosed with Sweet Syndrome secondary to receiving the Moderna Covid-19 vaccine, diagnosis of exclusion. He was also found to have methicillin-resistant Staphylococcus aureus pneumonia via culture of expectorated sputum on 10/31/23. He was treated with ampicillin-sulbactam 10/30/23-11/3/23; clindamycin 11/3/23-11/7/23; doxycycline, piperacillin-tazobactam, and linezolid 11/7/23-11/13/23; and prednisone 11/9/23-current (60 mg 11/9-11/17, 40 mg 11/18-current, planning for a taper).
Sex: F
Vaccine: COVID19, PNC20, RSV
Symptoms: Asthenia, Dizziness, Dysphonia, Headache, Heart rate increased
Clinical narrative: On the early evening of Saturday, 12/09/2023 I received three vaccinations at our Local store. The Vaccinations were: RSV AREXVY, COMIRNATY 12+ (COVID) 23-24 PFS and PREVNAR 20. During mid-day, Sunday, 12/10/2023 I developed a throbbing headache, felt dizzy, was hoarse, nauseous and was weak. I laid down on a couch and slept for 16 hours. On Monday, 12/11/2023 I was able to get up, but remained dizzy, weak and hoarse. I took my blood pressure and my pulse was as high as 103. FDA's approval of one, or more of these drugs, and having them injected at the same time may be the problem.
Sex: F
Vaccine: COVID19, PNC20, RSV
Symptoms: Hypersomnia, Nausea
Clinical narrative: On the early evening of Saturday, 12/09/2023 I received three vaccinations at our Local store. The Vaccinations were: RSV AREXVY, COMIRNATY 12+ (COVID) 23-24 PFS and PREVNAR 20. During mid-day, Sunday, 12/10/2023 I developed a throbbing headache, felt dizzy, was hoarse, nauseous and was weak. I laid down on a couch and slept for 16 hours. On Monday, 12/11/2023 I was able to get up, but remained dizzy, weak and hoarse. I took my blood pressure and my pulse was as high as 103. FDA's approval of one, or more of these drugs, and having them injected at the same time may be the problem.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: MMR given, MMRV ordered
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Infection, Pain, Pruritus, Rash
Clinical narrative: Soreness, pain, then rash, hives, lumps, face, neck, arms , lower abdomen all broke out rapidly. Severe itching, swelling, pain.  Needed medical attention as it continued to worsen and couldn?t work or sleep.  I have photos.  I?m still infected and broken out with itching and scratching!!
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder, Swelling, Urticaria
Clinical narrative: Soreness, pain, then rash, hives, lumps, face, neck, arms , lower abdomen all broke out rapidly. Severe itching, swelling, pain.  Needed medical attention as it continued to worsen and couldn?t work or sleep.  I have photos.  I?m still infected and broken out with itching and scratching!!
Age: 1.25
Sex: F
Vaccine: HEPA, PNC13
Symptoms: Wrong product administered
Clinical narrative: MMR given, MMRV ordered
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Wrong product administered
Clinical narrative: varicella given when MMRV ordered
Age: 1.5
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Patient was administered covid vaccine that was not diluted
Age: 56.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Moderna Spikevax mRNA Vaccine was administered on 12/15/23.  Thaw-out sticker on packaging expiration date is 12/13/23.  No adverse reaction; no treatment needed.  Moderna to be notified for any further recommendations.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Areflexia, Arthralgia, Asthenia, Diaphragm muscle weakness, Dyspnoea
Clinical narrative: The patient developed progressive lower extremity weakness roughly one week after receiving the RSV vaccine.  He then developed severe shoulder pain and thigh cramping which prompted him to report to the emergency room on 12/8/23.   The consulting neurologist discussed the patient' s history of Lyme disease and ehrlichiosis as potential causes, however the symptoms of those conditions were well known to the patient and the patient reported these symptoms to be completely different than he's experienced for these conditions.  The neurologist also noted diffuse weakness in the arms and legs with absent reflexes.  He was initiated on IVIG for empiric treatment of Guillan Barre Syndrome (GBS).  On 12/9/23 the patient had difficulty breathing and complained of increasing fatigue, and was found to be belly breathing/using accessory muscles to breathe.  He was intubated due to respiratory distress and impending fatigue.    The patient remains intubated at the date of this report (12/15/23), and continues to display profound weakness.  His quadreparesis and arreflexia continue to be present, per the electronic medical record, and he is still suspected to have GBS. His respiratory/diaphragmatic weakness has prevented him from being extubated.  It is possible that the patient may recover to a sufficient extent to be safely extubated during this hospital admission, however it is also possible that he will require tracheostomy placement and take longer to recover.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Endotracheal intubation, Fatigue, Guillain-Barre syndrome, Immunoglobulin therapy, Muscle spasms
Clinical narrative: The patient developed progressive lower extremity weakness roughly one week after receiving the RSV vaccine.  He then developed severe shoulder pain and thigh cramping which prompted him to report to the emergency room on 12/8/23.   The consulting neurologist discussed the patient' s history of Lyme disease and ehrlichiosis as potential causes, however the symptoms of those conditions were well known to the patient and the patient reported these symptoms to be completely different than he's experienced for these conditions.  The neurologist also noted diffuse weakness in the arms and legs with absent reflexes.  He was initiated on IVIG for empiric treatment of Guillan Barre Syndrome (GBS).  On 12/9/23 the patient had difficulty breathing and complained of increasing fatigue, and was found to be belly breathing/using accessory muscles to breathe.  He was intubated due to respiratory distress and impending fatigue.    The patient remains intubated at the date of this report (12/15/23), and continues to display profound weakness.  His quadreparesis and arreflexia continue to be present, per the electronic medical record, and he is still suspected to have GBS. His respiratory/diaphragmatic weakness has prevented him from being extubated.  It is possible that the patient may recover to a sufficient extent to be safely extubated during this hospital admission, however it is also possible that he will require tracheostomy placement and take longer to recover.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Muscular weakness, Quadriparesis, Respiration abnormal, Respiratory distress, Respiratory muscle weakness
Clinical narrative: The patient developed progressive lower extremity weakness roughly one week after receiving the RSV vaccine.  He then developed severe shoulder pain and thigh cramping which prompted him to report to the emergency room on 12/8/23.   The consulting neurologist discussed the patient' s history of Lyme disease and ehrlichiosis as potential causes, however the symptoms of those conditions were well known to the patient and the patient reported these symptoms to be completely different than he's experienced for these conditions.  The neurologist also noted diffuse weakness in the arms and legs with absent reflexes.  He was initiated on IVIG for empiric treatment of Guillan Barre Syndrome (GBS).  On 12/9/23 the patient had difficulty breathing and complained of increasing fatigue, and was found to be belly breathing/using accessory muscles to breathe.  He was intubated due to respiratory distress and impending fatigue.    The patient remains intubated at the date of this report (12/15/23), and continues to display profound weakness.  His quadreparesis and arreflexia continue to be present, per the electronic medical record, and he is still suspected to have GBS. His respiratory/diaphragmatic weakness has prevented him from being extubated.  It is possible that the patient may recover to a sufficient extent to be safely extubated during this hospital admission, however it is also possible that he will require tracheostomy placement and take longer to recover.
Age: 65.0
Sex: M
Vaccine: RSV
Symptoms: Use of accessory respiratory muscles
Clinical narrative: The patient developed progressive lower extremity weakness roughly one week after receiving the RSV vaccine.  He then developed severe shoulder pain and thigh cramping which prompted him to report to the emergency room on 12/8/23.   The consulting neurologist discussed the patient' s history of Lyme disease and ehrlichiosis as potential causes, however the symptoms of those conditions were well known to the patient and the patient reported these symptoms to be completely different than he's experienced for these conditions.  The neurologist also noted diffuse weakness in the arms and legs with absent reflexes.  He was initiated on IVIG for empiric treatment of Guillan Barre Syndrome (GBS).  On 12/9/23 the patient had difficulty breathing and complained of increasing fatigue, and was found to be belly breathing/using accessory muscles to breathe.  He was intubated due to respiratory distress and impending fatigue.    The patient remains intubated at the date of this report (12/15/23), and continues to display profound weakness.  His quadreparesis and arreflexia continue to be present, per the electronic medical record, and he is still suspected to have GBS. His respiratory/diaphragmatic weakness has prevented him from being extubated.  It is possible that the patient may recover to a sufficient extent to be safely extubated during this hospital admission, however it is also possible that he will require tracheostomy placement and take longer to recover.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain
Clinical narrative: "Mild" headache (rated 3-4/10 with no OTC, 2/10 with tylenol) starting several hours after vaccine and continuing until present date.  Denies vision changes, numbness tingling to face/limbs, difficulties with balance/ambulation, n/v or any other associated symptom now or in the days since vaccine.  Patient alert, oriented, appropriate during telephonic report of s/s, speech clear.  Partner present with patient. Also reports arm where vaccine is placed continue to be sore to touch; does not note associated edema/erythema/decreased range of motion or any other associated symptom.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered 2 days after expiration. No adverse reaction reported; client contacted and instructed to be vaccinated again.
Age: 1.0
Sex: M
Vaccine: COVID19, FLUC4, HEPA, MMR, VARCEL
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: 6 months-4 year dose of COVID-19 vaccine was administered in its undiluted form.   While this is an error, I feel very strongly that this is a manufacturer issue that needs to be resolved. It is highly confusing for the clinical staff to have 3 versions of a vaccine based on age, 2 of which are ready to use, and one requiring dilution AND in a multidose form.
Age: 61.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Moderna Spikevax was administered on 12/15/23.  The thaw-out expiration sticker is 12/13/23.  No adverse reaction noted.  No medical treatment necessary.  Moderna to be contacted for any further recommendations.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: hives two hours post vaccine
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Heart rate decreased, Hypotension, Loss of consciousness, Malaise, Posture abnormal
Clinical narrative: PATIENT RECEIVED MENVEO VACCINE AND WAS ASKED TO STAY FOR 15 MINUTES, HE WALKED TOWARDS THE PICK UP AREA OF OUR PHARMACY AND WALKED BACK TO PHARMACY BECAUSE WAS NOT FEELING WELL AND WANTED WATER. PATIENT SAT IN CHAIR AND SLUMPED OVER, PASSING OUT, EMS WAS CALLED IMMEDIATELY. VITALS TAKEN BY PHARMACIST SHOWED LOW BLOOD PRESSURE AND  LOW HEART RATE, PATIENT HAD PULSE ENTIRE TIME, PASSED OUT ONLY FOR A FEW SECONDS.-CAME TO AND KNEW HIS NAME, WHERE HE WAS, ETC
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Exposure via eye contact, Immunisation, Needle issue, Underdose
Clinical narrative: During time of administration, the needle came off during the push of plunger to give vaccine. The needle tip came off of the syringe and less than half of the vaccine was given. Some of the vaccine contents went into the patient's eye. The vaccine was repeated since less than half was administered into the patient's arm.
Age: 57.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse event, just given outside of recommended age range.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: VACCINE FROZEN INSTEAD OF REFRIGERATED
Age: 56.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pfizer covid 19 vaccine was administered 12/15/23.  The thaw-out sticker expiration date is 12/11/23.  No adverse reaction noted.  No medical intervention necessary.  Pfizer notified bending response for recommendations.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia, Back pain, COVID-19, Chest pain
Clinical narrative: Admit date: 12/4/2023  Discharge date: 12/5/2023  Admitting Physician:  Reason for Admission: Acute respiratory insufficiency  Brief Summary of Hospital Stay: Per HPI, a 93 year old female with a history of PE, CAD, Aortic stenosis, CHF, CKD stage III, RA, PMR, and osteoarthritis who presents to the ED with weakness, dyspnea, and myalgias. Patient reports her symptoms began yesterday. They include fever, chills, myalgias, chest pain, palpitations, headache, nausea, dyspnea, cough, and nasal congestion. She went to bed last evening and she was barely able to move. She reports she had pain everywhere including her shoulders, lower back, and chest. States she had Covid two years ago but she is in more pain this time around. Does admit to having a PE when she had covid. Did not get vaccinated because "a vaccine almost killed me."She denies urinary symptoms, sore throat, diarrhea, constipation, lower extremity edema, or vomiting. In the ED, patient was hemodynamically stable though febrile. Covid positive. She did desaturate when asleep and was placed on 2 liters nasal cannula. She was treated symptomatically. Due to her weakness, patient will be admitted under observation for further management. Discharged to Home.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Headache, Mobility decreased
Clinical narrative: Admit date: 12/4/2023  Discharge date: 12/5/2023  Admitting Physician:  Reason for Admission: Acute respiratory insufficiency  Brief Summary of Hospital Stay: Per HPI, a 93 year old female with a history of PE, CAD, Aortic stenosis, CHF, CKD stage III, RA, PMR, and osteoarthritis who presents to the ED with weakness, dyspnea, and myalgias. Patient reports her symptoms began yesterday. They include fever, chills, myalgias, chest pain, palpitations, headache, nausea, dyspnea, cough, and nasal congestion. She went to bed last evening and she was barely able to move. She reports she had pain everywhere including her shoulders, lower back, and chest. States she had Covid two years ago but she is in more pain this time around. Does admit to having a PE when she had covid. Did not get vaccinated because "a vaccine almost killed me."She denies urinary symptoms, sore throat, diarrhea, constipation, lower extremity edema, or vomiting. In the ED, patient was hemodynamically stable though febrile. Covid positive. She did desaturate when asleep and was placed on 2 liters nasal cannula. She was treated symptomatically. Due to her weakness, patient will be admitted under observation for further management. Discharged to Home.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nasal congestion, Nausea, Oxygen saturation decreased, Pain
Clinical narrative: Admit date: 12/4/2023  Discharge date: 12/5/2023  Admitting Physician:  Reason for Admission: Acute respiratory insufficiency  Brief Summary of Hospital Stay: Per HPI, a 93 year old female with a history of PE, CAD, Aortic stenosis, CHF, CKD stage III, RA, PMR, and osteoarthritis who presents to the ED with weakness, dyspnea, and myalgias. Patient reports her symptoms began yesterday. They include fever, chills, myalgias, chest pain, palpitations, headache, nausea, dyspnea, cough, and nasal congestion. She went to bed last evening and she was barely able to move. She reports she had pain everywhere including her shoulders, lower back, and chest. States she had Covid two years ago but she is in more pain this time around. Does admit to having a PE when she had covid. Did not get vaccinated because "a vaccine almost killed me."She denies urinary symptoms, sore throat, diarrhea, constipation, lower extremity edema, or vomiting. In the ED, patient was hemodynamically stable though febrile. Covid positive. She did desaturate when asleep and was placed on 2 liters nasal cannula. She was treated symptomatically. Due to her weakness, patient will be admitted under observation for further management. Discharged to Home.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Pyrexia, SARS-CoV-2 test positive
Clinical narrative: Admit date: 12/4/2023  Discharge date: 12/5/2023  Admitting Physician:  Reason for Admission: Acute respiratory insufficiency  Brief Summary of Hospital Stay: Per HPI, a 93 year old female with a history of PE, CAD, Aortic stenosis, CHF, CKD stage III, RA, PMR, and osteoarthritis who presents to the ED with weakness, dyspnea, and myalgias. Patient reports her symptoms began yesterday. They include fever, chills, myalgias, chest pain, palpitations, headache, nausea, dyspnea, cough, and nasal congestion. She went to bed last evening and she was barely able to move. She reports she had pain everywhere including her shoulders, lower back, and chest. States she had Covid two years ago but she is in more pain this time around. Does admit to having a PE when she had covid. Did not get vaccinated because "a vaccine almost killed me."She denies urinary symptoms, sore throat, diarrhea, constipation, lower extremity edema, or vomiting. In the ED, patient was hemodynamically stable though febrile. Covid positive. She did desaturate when asleep and was placed on 2 liters nasal cannula. She was treated symptomatically. Due to her weakness, patient will be admitted under observation for further management. Discharged to Home.
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Oxygen saturation decreased, Throat tightness, Vomiting
Clinical narrative: Event details per patient's report:  She obtained the flu vaccine at the school she teaches at. First symptom was vomiting, which started ~4 hours after receiving the vaccine. Then she felt short of breath, felt her throat was closing up, found to have low O2 in the ED. She says she was given benadryl shot, steroids, and something else which did help her vomiting, patient didn't recall the exact treatment received and we do not have outside records of this event. However, took awhile for her breathing took awhile for it to return to normal. She might have ate popcorn prior to her vomiting episode, but she cannot remember. Denies any rash / itching during this reaction. Denies diarrhea too. In the past, she has developed some pleurisy after flu shots and general feelings of being unwell, but nothing similar to this. Other details are not known.  All event details were provided by patient.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: Vaccine was frozen instead of refrigerated.
Age: 77.0
Sex: F
Vaccine: RSV
Symptoms: Burning sensation, Diarrhoea, Immediate post-injection reaction, Malaise, Nausea
Clinical narrative: She got her vaccine, right after she got it she always gets burning in her sinuses and then goes away.  She didn't have any trouble until about 5:00 PM she started to get nauseous.  Then at 6:30 she started vomiting every 15 minutes until 8:30 PM.  Then she had diarrhea too.  She did not take anything for her symptoms.  She is not having any symptoms at this time.  She did not feel too good when she got up, but has not vomited this morning.