chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, Pain
Clinical narrative: body ache; administered with 2 doses of fluzone qiv np on both arms, 5 minutes apart with no reported adverse event; Initial information received on 22-Nov-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 30-year-old female patient who was administered with 2 doses of influenza quadrival A-B vaccine [Fluzone QIV] on both arms, 5 minutes apart with no reported adverse event and had body ache.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included polio vaccine for Prophylactic vaccination.  On 17-Nov-2023, the patient received 0.5 ml dose of suspect influenza quadrival A-B vaccine, Suspension for injection (strength, expiry date: unknown) (lot: U8192AA) via intramuscular route in left and right deltoid for Immunization and administered with 2 doses of fluzone qiv np on both arms, 5 minutes apart with no reported adverse event (extra dose administered) (latency: same day)  On 19-Nov-2023 the patient had an event of body ache (pain) (latency: 2 days) following the administration of influenza quadrival A-B vaccine.  It was unknown if any lab data/test results available.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown for the event.     This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 57.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Axillary mass, Erythema, Peripheral swelling
Clinical narrative: Swollen arm/ swelling went down; Arm, which was really red / Redness in the armpit; Lump underneath armpit; This spontaneous case was received on 21-Nov-2023, reported by other healthcare professional via Communications (reference number: SEQW23-04422), and concerned a 57-year-old, female patient.   The patient's concurrent conditions included diabetes, high cholesterol, and high blood pressure (HBP). The patient's concomitant medications losartan, metformin, Ozempic (Semaglutide) used for unreported indication and an unspecified cholesterol medication.  On 17-Nov-2023, reported as on Friday, the patient was vaccinated with Afluria Quadrivalent (Influenza vaccine inact split 4v; dose: 0.5 ml, anatomical location, route of administration: not reported) for influenza immunization. The batch number reported was P100587735 and expiry date was 09-Jun-2024.   On the same date, the patient was vaccinated with non-company co-suspect COVID-19 vaccine (brand not specified, dose, route of administration, anatomical location, and indication: not reported). The batch number was not reported.   On 19-Nov-2023, two days after receiving Afluria Quadrivalent and non-company, co-suspect COVID-19 vaccine, the patient experienced swollen arm, which was really red and lump underneath her armpit. It was reported that swelling went down. No treatment measures were taken for the events.  At the time of initial reporting, on 21-Nov-2023, the patient was recovering from all events. As reported, symptoms were improving.  The reporter did not provide a causality assessment.  The case was assessed as non-serious.  Company comment: A 57-year-old, female patient experienced peripheral swelling, erythema, and axillary mass two days after being vaccinated with Afluria Quadrivalent and with non-company co-suspect COVID-19 vaccine. Despite confounding by co-suspect vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for reported events is assessed as possibly related, due to plausible temporal relationship.; Sender's Comments: A 57-year-old, female patient experienced peripheral swelling, erythema, and axillary mass two days after being vaccinated with Afluria Quadrivalent and with non-company co-suspect COVID-19 vaccine. Despite confounding by co-suspect vaccine, causal role of the suspect product cannot be excluded. Therefore, causality for reported events is assessed as possibly related, due to plausible temporal relationship.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: Red, itchy, swollen and painful welt at injection site.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Red, itchy, swollen and painful welt at injection site.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Pyrexia
Clinical narrative: Fever
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Back pain, Decreased appetite, Diarrhoea, Flank pain, Headache
Clinical narrative: nausea, diarrhea, loss of appetite, headache, back pain, left waist pain, fever to 100.1, sneezing, runny nose, congestion
Age: 65.0
Sex: F
Vaccine: FLUA4
Symptoms: Nausea, Respiratory tract congestion, Rhinorrhoea, Sneezing
Clinical narrative: nausea, diarrhea, loss of appetite, headache, back pain, left waist pain, fever to 100.1, sneezing, runny nose, congestion
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Chest discomfort, Chills, Dyspnoea, Loss of consciousness
Clinical narrative: Extreme muscle pain and chills for 2-3 days after vaccination A couple hours after symptoms started, I passed out on the floor after waking up, very weak for the rest of the day  11/17 -  fever of 102 F - 1 hour after taking 200mg  ibuprofen  Had mild shortness of breath for several days after majority of symptoms had passes. Chest felt weird.  Not sure - but arm might still feel off?
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: Extreme muscle pain and chills for 2-3 days after vaccination A couple hours after symptoms started, I passed out on the floor after waking up, very weak for the rest of the day  11/17 -  fever of 102 F - 1 hour after taking 200mg  ibuprofen  Had mild shortness of breath for several days after majority of symptoms had passes. Chest felt weird.  Not sure - but arm might still feel off?
Sex: F
Vaccine: HPV4
Symptoms: Immunisation reaction
Clinical narrative: Nurse calling to report patient had a reaction to GARDASIL administration in the past.  Nurse stated that they recalled a female patient had a reaction after being administered GARDASIL "years ago" before the change to GARDASIL 9, but was unable to p; This spontaneous report was received from a registered Nurse and referred to a female patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On an unknown date (years ago), the patient was vaccinated with 3 doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, 0.5 milligram, administered intramuscularly for prophylaxis (strength, lot #, and expiry date were not provided) before the change to hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).   On an unknown date, the nurse recalled the patient had a reaction to quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL). It was unable to provide specific timeline of adverse reaction or details of the reaction. Nurse confirmed that the reaction was not life threatening, the patient was not hospitalized, and the patient did not die. Nurse stated that all additional information was unknown due to a change in their electronic records. No additional information provided. At the time of reporting, the outcome of adverse reaction was not known. The causality between adverse reaction and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was unknown.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP called to report inadvertent administration of expired MMR-II to a patient. Product expired on 22NOV2023 and was administered on 27NOV2023. No additional AE/PQC.; HCP called to report inadvertent administration of expired MMR-II to a patient. Product expired on 22NOV2023 and was administered on 27NOV2023. No additional AE/PQC.; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 27-NOV-2023, the patient was inadvertently vaccinated with measles, mumps, and rubella (Wistar RA 27-3) virus vaccine, live (recombinant human albumin [rHA]) (M-M-R II) subcutaneous injection as prophylaxis (lot# W032494, expiry date: 22-NOV-2023; dose, route of administration and anatomical location not reported) (expired product administered). There was no additional adverse event (AE) (no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: Received a Dose of Hepatitis B Vaccine and a Different Dose of Heplisav-B; Initial report received on 17-Oct-2023   The Center on behalf of a consumer (state not reported) reported that a female patient (age, race, and ethnicity not provided) received a dose of Hepatitis B vaccine and a different dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization.  Allergies, previous reactions to other vaccines, or medications were not reported.  On an unspecified date, the patient received a dose of a Hepatitis B vaccine (product name and manufacturer unknown) (Lot #, expiration date, NDC #, route and site of administration not reported) from one provider.   On an unspecified date, the patient received HEPLISAV-B (Lot #, expiration date, NDC #, route and site of administration not reported) from another provider. No symptoms reported.   No additional information was provided.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: 12 Year-Old Female Patient Received a First Dose of Heplisav-B; Initial Report Received on 27-Oct-2023  A nurse reported that a 12-year-old female patient (race, and ethnicity not provided) received the first and second doses of Heplisav-B.  Medical history and allergies at the time of vaccination were not reported. Medications at the time of vaccination were not reported.  On 29-Sep-2023, the patient received the first dose of HEPLISAV-B (NDC # 43528-003-05, lot # 941593, and expiration date of 31-Aug-2025; route of administration not reported) in the right deltoid for hepatitis B immunization.   On 27-Oct-2023, the patient received the second dose of HEPLISAV-B (NDC # 43528-003-05, lot # 941593, and expiration date of 31-Aug-2025; route and site of administration not reported) for hepatitis B immunization. No adverse reactions were reported.  No additional information was reported.   Company Comment:  The company considers the event as non-serious.; Sender's Comments: The company considers the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products, No adverse event
Clinical narrative: Received the First Dose of Heplisav-B on 09/25/2023, and Then Received a Dose of Energix-B; Initial report received on 01-Nov-2023  A pharmacist reported that a male patient (age, race, and ethnicity unknown) received the first dose of HEPLISAV-B (hepatitis B vaccine) for hepatitis B immunization and then received a dose of Energix-B later.   Medical history, allergies, and concomitant medications at the time of vaccination were unknown.   On 25-Sep-2023, the patient received the first dose of HEPLISAV-B (Lot # 941428, expiration date 30 Apr-2025, and NDC # 4352800301) intramuscularly in the left deltoid.  On 01-Nov-2023, 38 days after having been vaccinated with HEPLISAV-B, the patient received a dose of Energix-B (Lot #, expiration date, NDC #, route, and injection site not reported). The patient did not report any side effects.  No additional information was available.  Company Comment:  The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Tested positive for covid on 11/23/23; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for covid on 11/23/23) in an adult male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (batch no. 3032086) for COVID-19 prophylaxis.     Patient has a compromised immune system.  The patient's past medical history included COVID-19 (Tested positive for Covid-19) in July 2021. Previously administered products included for Product used for unknown indication: Flu shot same day. Past adverse reactions to the above products included No adverse event with Flu shot same day.    On 11-Oct-2023, the patient received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (unknown route) .5 milliliter. On 23-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024 PFS), the patient experienced COVID-19 (Tested positive for covid on 11/23/23). At the time of the report, COVID-19 (Tested positive for covid on 11/23/23) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Nov-2023, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024 PFS) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  He haven´t seen a doctor about this. He mentioned that the vaccine didn´t really work since he caught Covid-19. Maybe it wasn´t handled properly at the pharmacy. He took 2 Covid tests and they were both positive. He was feeling tired, fatigued, had headaches, sinus, congestion, a tiny bit of a chill. He thought maybe it was something in the atmosphere. He would fall asleep in the couch after work. He feels that the congestion was localized through his left nostril. He would blow his nose but couldn´t get anything out, even though he felt there was something. He was feeling better now but he was still waking up all stuffy in the morning. He will take a new test to make sure that it´s gone.  No treatment information was reported.   Most recent FOLLOW-UP information incorporated above includes: On 27-Nov-2023: Live significant follow-up received: reference number added, narrative was updated. On 27-Nov-2023: Live follow-up received:  Symptoms of Covid-19 added in narrative.
Age: 49.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Chest pain, Headache, Palpitations, Pyrexia
Clinical narrative: Headache,fever on second day,chest pain on third and forth day,heart palpitations
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Blood test, Crepitations, Infection, Magnetic resonance imaging, Pain
Clinical narrative: Swelling, hot and bunch on arm, Dr. said it was a frozen arm bc it would crack every time I moved it...low grade fever- saw an osteoarthritis specialist and rec'd therapy, saw an osteoarthritis surgeon and recommended surgery, set up surgery, couldn't perform complete replacement bc of infection, being treated for sepsis, MRSA, no recognizable arthritis before COVID shot. On a 6 wk regimen of antibiotics... pain and condition started when COVID shot was given.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Periarthritis, Peripheral swelling, Pyrexia, Sepsis, Skin warm
Clinical narrative: Swelling, hot and bunch on arm, Dr. said it was a frozen arm bc it would crack every time I moved it...low grade fever- saw an osteoarthritis specialist and rec'd therapy, saw an osteoarthritis surgeon and recommended surgery, set up surgery, couldn't perform complete replacement bc of infection, being treated for sepsis, MRSA, no recognizable arthritis before COVID shot. On a 6 wk regimen of antibiotics... pain and condition started when COVID shot was given.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Staphylococcal infection, X-ray
Clinical narrative: Swelling, hot and bunch on arm, Dr. said it was a frozen arm bc it would crack every time I moved it...low grade fever- saw an osteoarthritis specialist and rec'd therapy, saw an osteoarthritis surgeon and recommended surgery, set up surgery, couldn't perform complete replacement bc of infection, being treated for sepsis, MRSA, no recognizable arthritis before COVID shot. On a 6 wk regimen of antibiotics... pain and condition started when COVID shot was given.
Sex: M
Vaccine: RSV, RSV
Symptoms: Foetal exposure during pregnancy
Clinical narrative: Hypoxic Ischemic Encephalopathy; Accidental Exposure to fetus; This serious retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of hypoxic-ischemic encephalopathy in a male patient exposed to RSVPreF3 adjuvanted (Arexvy) (batch number 5BN3T, expiry date 05-NOV-2024) in utero. The mother received the product for prophylaxis.   Concurrent medical conditions included premature baby.   On an unknown date, the 30-year-old mother received Arexvy. The patient was diagnosed with hypoxic-ischemic encephalopathy (Verbatim: Hypoxic Ischemic Encephalopathy) (serious criteria GSK medically significant) and fetal exposure during pregnancy, third trimester (Verbatim: Accidental Exposure to fetus). The outcome of the hypoxic-ischemic encephalopathy was not reported and the outcome of the fetal exposure during pregnancy, third trimester was unknown.   It was unknown if the reporter considered the hypoxic-ischemic encephalopathy to be related to Arexvy.     It was unknown if the company considered the hypoxic-ischemic encephalopathy to be related to Arexvy.   Pregnancy Details (Neonate 1):  Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with no apparent congenital anomaly Delivery Notes: baby was born pre-term   See case US2023159137 for details regarding the mother case.   Additional Information: GSK Receipt Date: 16-NOV-2023 The reporter was a husband called on behalf of his wife (patient).  The reporter stated that his wife went to the pharmacy to receive the RSV vaccine that was approved for a pregnant woman instead, she was given Arexvy which was not indicated for a pregnant woman. The husband stated at the time of vaccination wife was 35 weeks pregnant. At 36 weeks of pregnancy his wife had to be induced due to medical complications. The patient was induced and baby was born pre-term. The husband reported that after delivery his son needed to be transferred from hospital to specialty hospital for a diagnosis of HIE (Hypoxic Ischemic Encephalopathy). The reporter adamantly welcomed all physicians to receive follow up and he would like consent to follow up paperwork sent to his email address.  The reporter would sign and return Authorization to GlaxoSmithKline. The reporter consented to follow up. The case had been linked to the case US2023159137 with Parent-Child Link, reported by the same reporter.; Sender's Comments:  US-GSK-US2023159137:
Sex: M
Vaccine: RSV, RSV
Symptoms: Complication of pregnancy, Exposure during pregnancy, Induced labour, Live birth, Premature baby
Clinical narrative: Hypoxic Ischemic Encephalopathy; Accidental Exposure to fetus; This serious retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of hypoxic-ischemic encephalopathy in a male patient exposed to RSVPreF3 adjuvanted (Arexvy) (batch number 5BN3T, expiry date 05-NOV-2024) in utero. The mother received the product for prophylaxis.   Concurrent medical conditions included premature baby.   On an unknown date, the 30-year-old mother received Arexvy. The patient was diagnosed with hypoxic-ischemic encephalopathy (Verbatim: Hypoxic Ischemic Encephalopathy) (serious criteria GSK medically significant) and fetal exposure during pregnancy, third trimester (Verbatim: Accidental Exposure to fetus). The outcome of the hypoxic-ischemic encephalopathy was not reported and the outcome of the fetal exposure during pregnancy, third trimester was unknown.   It was unknown if the reporter considered the hypoxic-ischemic encephalopathy to be related to Arexvy.     It was unknown if the company considered the hypoxic-ischemic encephalopathy to be related to Arexvy.   Pregnancy Details (Neonate 1):  Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with no apparent congenital anomaly Delivery Notes: baby was born pre-term   See case US2023159137 for details regarding the mother case.   Additional Information: GSK Receipt Date: 16-NOV-2023 The reporter was a husband called on behalf of his wife (patient).  The reporter stated that his wife went to the pharmacy to receive the RSV vaccine that was approved for a pregnant woman instead, she was given Arexvy which was not indicated for a pregnant woman. The husband stated at the time of vaccination wife was 35 weeks pregnant. At 36 weeks of pregnancy his wife had to be induced due to medical complications. The patient was induced and baby was born pre-term. The husband reported that after delivery his son needed to be transferred from hospital to specialty hospital for a diagnosis of HIE (Hypoxic Ischemic Encephalopathy). The reporter adamantly welcomed all physicians to receive follow up and he would like consent to follow up paperwork sent to his email address.  The reporter would sign and return Authorization to GlaxoSmithKline. The reporter consented to follow up. The case had been linked to the case US2023159137 with Parent-Child Link, reported by the same reporter.; Sender's Comments:  US-GSK-US2023159137:
Sex: M
Vaccine: RSV, RSV
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Hypoxic Ischemic Encephalopathy; Accidental Exposure to fetus; This serious retrospective pregnancy case was reported by a consumer via call center representative and described the occurrence of hypoxic-ischemic encephalopathy in a male patient exposed to RSVPreF3 adjuvanted (Arexvy) (batch number 5BN3T, expiry date 05-NOV-2024) in utero. The mother received the product for prophylaxis.   Concurrent medical conditions included premature baby.   On an unknown date, the 30-year-old mother received Arexvy. The patient was diagnosed with hypoxic-ischemic encephalopathy (Verbatim: Hypoxic Ischemic Encephalopathy) (serious criteria GSK medically significant) and fetal exposure during pregnancy, third trimester (Verbatim: Accidental Exposure to fetus). The outcome of the hypoxic-ischemic encephalopathy was not reported and the outcome of the fetal exposure during pregnancy, third trimester was unknown.   It was unknown if the reporter considered the hypoxic-ischemic encephalopathy to be related to Arexvy.     It was unknown if the company considered the hypoxic-ischemic encephalopathy to be related to Arexvy.   Pregnancy Details (Neonate 1):  Number of Fetuses/Neonates: 1 Pregnancy Outcome: Live neonate with no apparent congenital anomaly Delivery Notes: baby was born pre-term   See case US2023159137 for details regarding the mother case.   Additional Information: GSK Receipt Date: 16-NOV-2023 The reporter was a husband called on behalf of his wife (patient).  The reporter stated that his wife went to the pharmacy to receive the RSV vaccine that was approved for a pregnant woman instead, she was given Arexvy which was not indicated for a pregnant woman. The husband stated at the time of vaccination wife was 35 weeks pregnant. At 36 weeks of pregnancy his wife had to be induced due to medical complications. The patient was induced and baby was born pre-term. The husband reported that after delivery his son needed to be transferred from hospital to specialty hospital for a diagnosis of HIE (Hypoxic Ischemic Encephalopathy). The reporter adamantly welcomed all physicians to receive follow up and he would like consent to follow up paperwork sent to his email address.  The reporter would sign and return Authorization to GlaxoSmithKline. The reporter consented to follow up. The case had been linked to the case US2023159137 with Parent-Child Link, reported by the same reporter.; Sender's Comments:  US-GSK-US2023159137:
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: interval between first dose and seocnd dose short; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a adult female patient who received HAV (Havrix adult) for prophylaxis.   Concomitant products included Hepatitis a vaccine inact (Havrix adulti).   On 06-JUN-2023, the patient received the 2nd dose of Havrix adult. On 06-JUN-2023, an unknown time after receiving Havrix adult and 31 days after receiving Havrix adulti, the patient experienced drug dose administration interval too short (Verbatim: interval between first dose and seocnd dose short). The outcome of the drug dose administration interval too short was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: The reporter was patient. The patient asked about 3rd dose of Havrix adult. Adverse event (AE) was filed with minimal information. The patient received 2nd dose of Havrix adult earlier than the recommended schedule, which led to shortening of vaccination schedule. The reporter consented to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Incomplete course of vaccination
Clinical narrative: hadn't received the 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 22-year-old female patient who received HAV (Havrix) for prophylaxis.   Previously administered products included Havrix (In October 2020, received first dose).   On an unknown date, the patient did not receive Havrix. On an unknown date, an unknown time after receiving Havrix, the patient experienced incomplete course of vaccination (Verbatim: hadn't received the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 20-NOV-2023 Reporter called to informed that a patient that got the 1st dose of Havrix back in October 202 and did not receive the 2nd dose yet. The reporter consented to follow up. Till the time of reporting the patient did not receive the booster dose of Havrix  vaccine, which led to incomplete course of vaccination.
Age: 65.0
Sex: M
Vaccine: COVID19, FLU4, RSV
Symptoms: Rash pruritic, Skin texture abnormal
Clinical narrative: Rash, itches like crazy, feels calased under skin
Age: 93.0
Sex: M
Vaccine: COVID19-2
Symptoms: Confusional state, Gait disturbance, Incoherent, Mobility decreased
Clinical narrative: Confusion, inability to talk coherently, lack of mobility, almost fell several times
Age: 32.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain, Asthenia
Clinical narrative: Oral Typhoid vaccine taken at home. First dose taken on 11/27 around 7:30 am with no side effects. Second dose taken on 11/29 around 7 am. One hour later (around 8:20 am) abdominal pain started. Pain came in waves (on and off) all day. By 5 pm pain was semi-debilitating. The only thing that made the pain bearable/dissipate was laying down/being horizontal. Took two Pepto-Bismol tablets around 2 and 3pm, these did not have any effect.  Pain on 11/30 is minimal but not completely dissipated.  Will contact health care provider to advise on taking dose 3 and 4.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Pyrexia, Somnolence
Clinical narrative: Low grade fever and excess drowsiness for two days following the vaccine.
Age: 67.0
Sex: F
Vaccine: COVID19-2, FLU4
Symptoms: Injection site erythema, Injection site warmth, Pain, Pain in extremity
Clinical narrative: PATIENT RECEIVED BOTH FLU HD AND SPIKEVAX AT THE SAME TIME IN THE SAME ARM. PATIENT STATED THAT SHE STARTED EXPERICING PAIN ON LIFTING THE ARM, RED AREA AROUND THE SITE THAT STARTED TO SPREAD AND GET HOT TO TOUCH, HER HAND ON THE SAME ARM STARTED HURTIN ON 11/27/23 LATER THAT NIGHT.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain, Computerised tomogram abdomen abnormal, Gastrointestinal infection, White blood cell count increased
Clinical narrative: 48 hours after vaccination I experienced abdominal pain, went to the doctor for it 10/24/23, blood test showed white count as 17.5, ct scan diagnosed massive intestinal infection, hospitalized for 3 days on IV antibiotics
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Malaise, Oropharyngeal pain, Pharyngeal erythema, Pyrexia
Clinical narrative: Temp 101.7 orally, sore throat, malaise, red throat.  Donor took Tylenol at 0745 11/30/2023
Age: 65.0
Sex: F
Vaccine: COVID19-2
Symptoms: Magnetic resonance imaging head normal, Scan with contrast normal, Tinnitus
Clinical narrative: developed pulsatile tinnatus - no reason found otherwise; had  MRI of head - neg results; symptoms has lessened over time but not fully resolved
Age: 12.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: Patient was given a dose of the vaccine for ages 6 months-11 years but patient is 12 years old.  Patient received 1/2 the recommended dose.
Age: 16.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Ear pain, Oropharyngeal pain, Rhinorrhoea
Clinical narrative: Cough, runny nose, sore throat, ear pain
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Headache, Influenza virus test negative, SARS-CoV-2 test negative, Vomiting
Clinical narrative: Within 1 hour of receiving the vaccine, the patient developed lightheadedness and profuse vomiting followed by severe frontotemporal headahce. The symptoms were severe for 24 hours and then moderate for an additional 24 hours.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Pain in extremity, Vertigo
Clinical narrative: A few hours after the injection, I noticed that I was dizzy. I felt as if the room was spinning. The next day (today), I still feel dizzy especially when I bend over to pick up an object. Other than a sore left arm, I have no other side effects.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: Went into AFib from 10/1/2023 2:55 am until 10/2/23 12:35 am
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Fatigue, Mobility decreased, Pain, Pain in extremity
Clinical narrative: Started with slight pain in left arm,continued to get worse.Ended up couldn't raise my arm with using other arm to help. Pain got so bad. Ended up with surgery on my shoulder. Still have pain,tired all the time,no energy.Never had pain like this before.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Rotator cuff repair
Clinical narrative: Started with slight pain in left arm,continued to get worse.Ended up couldn't raise my arm with using other arm to help. Pain got so bad. Ended up with surgery on my shoulder. Still have pain,tired all the time,no energy.Never had pain like this before.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Back disorder, Chills, Dizziness, Fatigue, Gait disturbance
Clinical narrative: Spikevax. I was very very tired and my left arm was hurting. As I went to bed around 10:30 I had very bad chills/shaking. Headache. Chills subsided, then I had a fever and I was lightheaded and unable to control my bladder. The shaking and chills effected my back issues and hurt my back even more than normal. I was unsteady on my feet. By morning time I was very cold but no chills or shaking. Still have a headache. No fever. The next day I felt droopy and unsteady on my feet. I feel lightheaded and still unsteady today. Left side of the base of my neck I have large swelling. It is tender and it has the circumference of a lemon. I had this with my last Covid shot (12/12/2022) and it lasted a week or 2.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pyrexia, Swelling, Tremor
Clinical narrative: Spikevax. I was very very tired and my left arm was hurting. As I went to bed around 10:30 I had very bad chills/shaking. Headache. Chills subsided, then I had a fever and I was lightheaded and unable to control my bladder. The shaking and chills effected my back issues and hurt my back even more than normal. I was unsteady on my feet. By morning time I was very cold but no chills or shaking. Still have a headache. No fever. The next day I felt droopy and unsteady on my feet. I feel lightheaded and still unsteady today. Left side of the base of my neck I have large swelling. It is tender and it has the circumference of a lemon. I had this with my last Covid shot (12/12/2022) and it lasted a week or 2.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Urinary incontinence
Clinical narrative: Spikevax. I was very very tired and my left arm was hurting. As I went to bed around 10:30 I had very bad chills/shaking. Headache. Chills subsided, then I had a fever and I was lightheaded and unable to control my bladder. The shaking and chills effected my back issues and hurt my back even more than normal. I was unsteady on my feet. By morning time I was very cold but no chills or shaking. Still have a headache. No fever. The next day I felt droopy and unsteady on my feet. I feel lightheaded and still unsteady today. Left side of the base of my neck I have large swelling. It is tender and it has the circumference of a lemon. I had this with my last Covid shot (12/12/2022) and it lasted a week or 2.
Age: 82.0
Sex: F
Vaccine: RSV, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Insomnia, Pain, Rash
Clinical narrative: Objective clinical eval: Redness around injection site about 3-4 inches up and down arm. warm to touch.  (marked red area for patient to evaluate worsening). Just noticed rash this morning 11/30/2023  sore per patient & trouble sleeping per patient. starting 11/27/2023 evening and continued  Advised to take 1 benadryl and 1 aleve or motrin & to re-evaluate redness if lessens & pain, if does not lessen then call MD for him to evaluate and maybe present RX for steroid.
Age: 90.0
Sex: M
Vaccine: FLUA4
Symptoms: Deafness
Clinical narrative: hearing loss
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Anal incontinence, Loss of consciousness, Rectal ulcer, Urinary incontinence
Clinical narrative: Patient lost consciousness approximately 1 hour after administration while sitting in his recliner at home. He lost control of bodily function and urinated and defecated in his chair.  He developed sores around his rectum that needed attention by the wound clinic at hospital.   He spent 6 days in the hospital for care of the sores. He then was transferred to a step down /rehab center for 5 days where he checked himself out due to lack of quality care.   He just reported this incident to me today, 11/30/2023.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Tendon rupture
Clinical narrative: Ruptured tendon in left arm occurring at 8 pm the day of the injection. Patient is being treated outpatient.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site pruritus, Urticaria
Clinical narrative: Patient developed hives on body about 1.5 hours after receiving flu vaccine in clinic. Called in @ 11:46 am & spoke with triage nurse, reported "neck is welted & red". At the time of call mother reported that she was itching site but her breathing was okay. Was advised to take pt to ER if any breathing difficulties developed & to start children's Benadryl.  Patient was scheduled for evaluation in office on 11/30/23 @ 10 am. Patient presented in office at this time with hives present on face, torso, arms, & legs.  Physician recommending 2nd gen Antihistamine use (cetirizine) daily with continued benadryl as needed. If no resolution with these options, would do a short steroid course in the form of prednisolone x 5-7 days with taper. Continue monitoring for concerning features including mouth/lip/tongue swelling or tingling, throat swelling, difficulty breathing. Should have skin allergy testing for common causes of reactions to flu vaccination.  Allergist appt scheduled for 11/30/23 @ 1:30 pm.
Age: 43.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site haematoma, Injection site pain
Clinical narrative: Right upper arm pain, hematoma
Age: 10.0
Sex: M
Vaccine: COVID19-2
Symptoms: Lip swelling, Peripheral swelling
Clinical narrative: Woke up with swollen hands and lips at 4 a.m. Given Tylenol and Benadryl, swelling subsided within an hour.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injection site pain, Pain, Pain in extremity
Clinical narrative: During vaccine administration patient reporting burning, shooting pain down arm into hand. Pain has continued since, with some improvement. Patient referred to physical therapy.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Tinnitus
Clinical narrative: ringing in ears not present before vaccine. This was not my first booster.
Age: 11.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient is fine, he went to school.
Age: 60.0
Sex: M
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Breakthrough COVID-19, Gait disturbance, Skin ulcer
Clinical narrative: Covid-19 Breakthrough Infection
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: The vaccine given was out of date by roughly a day. The pic of Walmart store 2002, called the manufacture(moderna) and after research they told the pic, the patient did not have to be given the vaccine again but to fill out a VAERS form.
Age: 66.0
Sex: M
Vaccine: FLUA4
Symptoms: Mobility decreased, Muscle discomfort, Pain in extremity
Clinical narrative: Arm pain and pulled muscle feeling. Unable to raise right arm fully up.
Age: 60.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 36.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Bell's palsy, Computerised tomogram, Magnetic resonance imaging, Scan with contrast
Clinical narrative: Bell's Palsy on left side of face. ER visit of 11/16/2023 to 11/17/2023
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea
Clinical narrative: diarrhea
Age: 54.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 62.0
Sex: F
Vaccine: COVID19-2
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 9.0
Sex: M
Vaccine: COVID19
Symptoms: Loss of personal independence in daily activities, Malaise
Clinical narrative: Felt generally ill with known Covid vaccine side effects so that Mother kept him home from school.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Product administered at inappropriate site
Clinical narrative: The individual reported: "I had an annual flu shot here on 9/20/23.  I had a gradual increase in pain at the injection site.  Shot given a little low on my lateral arm.  I suspect either it hit a tendon or a nerve.  Nothing seen on the outside, just pain inside.  Sometimes no pain that I notice and other times significant noticeable pain until I can rest the arm for a while. I plan on just waiting to see if it can heal and go away.  If it does not then I will see my primary care doctor. "
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The patient experiences swelling, hot, itchy, and redness near the injection site of the vaccine. This started immediately and has been getting progressively worse.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: Hours of chills. Very sick for 36 hours.  When I got my original vaccination (Pfizer) in 2021, I was so sick I passed out and hit my head on the way down, causing a bad concussion. Also very sick with second does in 2021 and dose in 2022.  I was quite sick after my flu dose a few years ago. It was a Hi Dose and subsequently I had the normal dose and am not sick anymore. So I think people who had bad reactions should be able to get a lower dose.
Age: 1.25
Sex: M
Vaccine: DTAP, FLU4, HIBV, PNC20
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives/uriticaria and fever developing < 24 hours after administration
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, DTPPVHBHPB, RV5
Symptoms: Burning sensation, Contusion, Vision blurred
Clinical narrative: One received there was screaming crating burning there is still a massive mark of burning under the skin which is now bruised . Vision get blurred on and off since then and the quality of life is not the same . So upset
Age: 84.0
Sex: M
Vaccine: RSV
Symptoms: Brain fog, Cough, Depression, Fatigue, Insomnia
Clinical narrative: Initially I could sleep. But after waking up I couldn't get up and function. Extreme fatigue. Coughing, Sneezing, Excessive phlegm, depression, irritability, brain fog at times. My mental acuity is diminished. Unable to sleep, severe insomnia.
Age: 84.0
Sex: M
Vaccine: RSV
Symptoms: Irritability, Loss of personal independence in daily activities, Mental impairment, Productive cough, Sleep disorder
Clinical narrative: Initially I could sleep. But after waking up I couldn't get up and function. Extreme fatigue. Coughing, Sneezing, Excessive phlegm, depression, irritability, brain fog at times. My mental acuity is diminished. Unable to sleep, severe insomnia.
Age: 84.0
Sex: M
Vaccine: RSV
Symptoms: Sneezing
Clinical narrative: Initially I could sleep. But after waking up I couldn't get up and function. Extreme fatigue. Coughing, Sneezing, Excessive phlegm, depression, irritability, brain fog at times. My mental acuity is diminished. Unable to sleep, severe insomnia.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Electrocardiogram, Syncope, Vomiting
Clinical narrative: Patient had syncopal episode post-vaccine accompanied by vomiting, chest pain; patient was given IV fluids, baby ASA, and EKG in clinic. EMS called, patient transported to ER.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Hypoaesthesia, Immediate post-injection reaction, Inflammation, Injected limb mobility decreased
Clinical narrative: From the patient: "  The injection site was very high on my left arm. It felt as if the nurse administering the vaccine hit resistance but continued to push the needle in further.    I immediately felt numbness in my left arm and pain at the injection site. The numbness turned to tingling then lasted several hours throughout that  day.   Although the immediate pain subsided, my arm and shoulder (especially in the joint) have continued to cause me pain and my mobility has become limited.   The administering nurse as well as other health professionals present offered me a snack and asked me to sit down. "
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Joint stiffness, Pain in extremity, Paraesthesia, Product administered at inappropriate site
Clinical narrative: From the patient: "  The injection site was very high on my left arm. It felt as if the nurse administering the vaccine hit resistance but continued to push the needle in further.    I immediately felt numbness in my left arm and pain at the injection site. The numbness turned to tingling then lasted several hours throughout that  day.   Although the immediate pain subsided, my arm and shoulder (especially in the joint) have continued to cause me pain and my mobility has become limited.   The administering nurse as well as other health professionals present offered me a snack and asked me to sit down. "
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: none
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Injected limb mobility decreased, Myalgia, Pain
Clinical narrative: The patient is so sore all over that she can barely move, starting on the day of administration, Tuesday, until today, Thursday. Her joints and muscles are extremely painful. She could not lift the arm that had the vaccine administered in it. The patient took a Tylenol #3 that she had, which helped minimally. I advised her to call her doctor to see what else she can do.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram, Hemiplegia, Magnetic resonance imaging
Clinical narrative: Paralysis of left side of body, Physical therapy, Occupational Therapy continuing. Not recovered.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Dyspnoea, Respiratory failure
Clinical narrative: Patient started to have shortness of breath advanced to respiratory failure
Age: 20.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus
Clinical narrative: donor reaction to tetanus Vaccination . donor received tetanus vaccination on 11/27 2023 donor complains of redness and itching donor didn't seek medical attention.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cardiac flutter, Chills, Extrasystoles, Headache, Mental impairment
Clinical narrative: Approximately 12 hours after each Covid vaccine (regardless of manufacture - Moderna, Pfizer or J&J - I?ve had all 3) I had the following reactions: Headache, fever, chills (shaking), nausea and rapidly, pounding heartbeats.  I did not go to an immediate care center or sought any medical attention as I was not informed that an abnormal heart-beat was a serious side effect that would require immediate medical attention/documentation.  Having a fever and very bad headache, I wasn?t able to think clearly, so my main concern was to take something to alleviate my headache and nausea.  I took advil and drank small sips of gingerale.  It was hours before my heartbeat returned to normal - unfortunately I did not write down the exact hours. Even after returning to it?s normal beat, it would sometimes flutter or skip beats. This lasted for a few days.  The headache and nausea last for a few days.  The fever subsided after the first full day following the vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Nausea, Palpitations, Pyrexia, Tremor
Clinical narrative: Approximately 12 hours after each Covid vaccine (regardless of manufacture - Moderna, Pfizer or J&J - I?ve had all 3) I had the following reactions: Headache, fever, chills (shaking), nausea and rapidly, pounding heartbeats.  I did not go to an immediate care center or sought any medical attention as I was not informed that an abnormal heart-beat was a serious side effect that would require immediate medical attention/documentation.  Having a fever and very bad headache, I wasn?t able to think clearly, so my main concern was to take something to alleviate my headache and nausea.  I took advil and drank small sips of gingerale.  It was hours before my heartbeat returned to normal - unfortunately I did not write down the exact hours. Even after returning to it?s normal beat, it would sometimes flutter or skip beats. This lasted for a few days.  The headache and nausea last for a few days.  The fever subsided after the first full day following the vaccine.
Age: 66.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Chills, Headache, Heart rate, Nausea, Palpitations
Clinical narrative: Approximately 12 hours after each Covid vaccine (regardless of manufacture - Moderna, Pfizer or J&J - I?ve had all 3) I had the following reactions: Headache, fever, chills (shaking), nausea and rapidly, pounding heartbeats.  I did not go to an immediate care center or sought any medical attention as I was not informed that an abnormal heart-beat was a serious side effect that would require immediate medical attention/documentation.  Having a fever and very bad headache, I wasn?t able to think clearly, so my main concern was to take something to alleviate my headache and nausea.  I took advil and drank small sips of gingerale.  It was hours before my heartbeat returned to normal - unfortunately I did not write down the exact hours. Even after returning to it?s normal beat, it would sometimes flutter or skip beats. This lasted for a few days.  The headache and nausea last for a few days.  The fever subsided after the first full day following the vaccine.