chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 9.0
Sex: F
Vaccine: COVID19-2
Symptoms: T-cell type acute leukaemia, Vomiting, White blood cell count increased
Clinical narrative: My daughter had a fever following the vaccine. She took Tylenol. The next several days she was tired but did not have a fever. She presented with a fever and stomach pain on July 18. She had vomiting so we took her to urgent care. They gave her anti nausea meds and said to go to another clinic to get blood tests if she didn?t start to feel better. We took her to get her blood checked on July 28 because she was still sick. Her WBC was incredibly high. We were sent to ER where they confirmed leukemia. We then took a life flight to hospital the same day, where they confirmed T-cell acute lymphoblastic leukemia. She began chemo therapy the following day, July 29.
Age: 44.0
Sex: F
Vaccine: COVID19-2
Symptoms: Lymph node pain, Lymphadenopathy
Clinical narrative: I had a lymph node along my collar bone swell to the size of a large marble. The lymph node was painful to the touch. The swelling subsided in about a week. The same lymph node swelled when I recorded my flu vaccine on October 24, 2023. This time the swelling lasted for two weeks.
Age: 41.0
Sex: M
Vaccine: HEP, VARCEL
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: PATIENT FAINTED IMMEDIATELY AFTER RECIEVEING VACCINATIONS.
Age: 41.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Brain fog, Dizziness, Headache
Clinical narrative: Ongoing severe headache, dizziness, brain fog
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Cough, Feeling hot, Headache, Immediate post-injection reaction, Limb discomfort
Clinical narrative: Right arm felt warm and heavy immediately after dose Eye pressure and mild headache 10 mins after dose: took Tylenol 1000 mg Cough, wheezing, postnasal drip and rhinorrhea after 4 hrs: used Albuterol and Trelegy (provided some Relief)
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular discomfort, Rhinorrhoea, Upper-airway cough syndrome, Wheezing
Clinical narrative: Right arm felt warm and heavy immediately after dose Eye pressure and mild headache 10 mins after dose: took Tylenol 1000 mg Cough, wheezing, postnasal drip and rhinorrhea after 4 hrs: used Albuterol and Trelegy (provided some Relief)
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient felt fine after the first 15 minutes. Around 4PM, patient called the pharmacy and said that her arm had swollen up and was red and itchy. Patient's husband had her put on an ice pack (as previously spoken about) and said that the swelling in her arm had gone down.
Age: 22.0
Sex: M
Vaccine: RAB
Symptoms: Chills, Pyrexia
Clinical narrative: Low-grade fever (101 F), chills starting approx. 5 hours post-vaccination and lasting approx. 10 hours
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Ear discomfort, Tinnitus
Clinical narrative: Ear discomfort and periodic fluttering sound in ear
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Anaphylactic reaction, Angioedema, Idiopathic urticaria, Laboratory test, Mouth swelling
Clinical narrative: Symptoms arrived less than 30 days after the first vaccine and then a second more intense reaction with the second vaccine six months later.  Severe hives and anaphylaxis symptoms at night. Swelling in the face, nose, and mouth and tongue areas. No pre-existing experience or diagnosis in the past. Diagnosed with idiopathic urticaria and angioedema.  I have been on very high doses of anti-histamines and singulair to suppress the overactive immune response.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Swelling face, Swollen tongue, Urticaria
Clinical narrative: Symptoms arrived less than 30 days after the first vaccine and then a second more intense reaction with the second vaccine six months later.  Severe hives and anaphylaxis symptoms at night. Swelling in the face, nose, and mouth and tongue areas. No pre-existing experience or diagnosis in the past. Diagnosed with idiopathic urticaria and angioedema.  I have been on very high doses of anti-histamines and singulair to suppress the overactive immune response.
Age: 40.0
Sex: M
Vaccine: TYP
Symptoms: Abdominal pain, Computerised tomogram abdomen abnormal, Enteritis, Pyrexia
Clinical narrative: Patient had severe abdominal pain and fever for 2 + days following vaccine administration
Age: 7.0
Sex: U
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Product complaint, Product label issue
Clinical narrative: box on Infanrix says 6 weeks to 7 years; Pharmaceutical product complaint; Nurse reported that back in June 2023 a 7 year old was administered Infanrix; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 7-year-old patient who received DTPa (Infanrix) for prophylaxis.   In JUN-2023, the patient received Infanrix. In JUN-2023, an unknown time after receiving Infanrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Nurse reported that back in June 2023 a 7 year old was administered Infanrix). On an unknown date, the patient experienced product label issue (Verbatim: box on Infanrix says 6 weeks to 7 years) and pharmaceutical product complaint (Verbatim: Pharmaceutical product complaint). The outcome of the inappropriate age at vaccine administration, product label issue and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 02-NOV-2023 Nurse reported that back in June 2023 a 7 year old was administered Infanrix, nurse days that although package insert says booster dose at 4 to 6 years of age, which led to Inappropriate age at vaccine administration.  The box on Infanrix says 6 weeks to 7 years and she went by that.  Patient was doing a catch up on the vaccines and it shows late for Dtap series because. No other details provided. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: For her previous vaccinations she had prolonged reactions to the vaccines.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (For her previous vaccinations she had prolonged reactions to the vaccines.) in an adult female patient who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     It was unknown if patient had relevant medical history or conditions, allergy, concomitant diseases and risk factor.     On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (For her previous vaccinations she had prolonged reactions to the vaccines.). At the time of the report, IMMUNISATION REACTION (For her previous vaccinations she had prolonged reactions to the vaccines.) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       It was unknown if the patient receives any other vaccine in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-748669 (E2B Linked Report). This case was linked to MOD-2023-748669 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748669:other vaccines
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Immunisation reaction
Clinical narrative: Symptoms reported have She states that she felt horrific; Call received from a patient stating that she has an immune deficiency and has taken previous Moderna vaccines and has had severe side effects with each one for 36 hours; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (Call received from a patient stating that she has an immune deficiency and has taken previous Moderna vaccines and has had severe side effects with each one for 36 hours) and FEELING ABNORMAL (Symptoms reported have She states that she felt horrific) in a female patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunodeficiency.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (Call received from a patient stating that she has an immune deficiency and has taken previous Moderna vaccines and has had severe side effects with each one for 36 hours) and FEELING ABNORMAL (Symptoms reported have She states that she felt horrific). At the time of the report, IMMUNISATION REACTION (Call received from a patient stating that she has an immune deficiency and has taken previous Moderna vaccines and has had severe side effects with each one for 36 hours) and FEELING ABNORMAL (Symptoms reported have She states that she felt horrific) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   No concomitant or treatment medications were provided. The patient took previous Moderna vaccines and had severe side effects with each one for 36 hours. The patient felt horrific.   This case was linked to US-MODERNATX, INC.-MOD-2023-748880 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Periarthritis
Clinical narrative: frozen shoulder; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PERIARTHRITIS (frozen shoulder) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On 06-Nov-2023, the patient experienced PERIARTHRITIS (frozen shoulder). At the time of the report, PERIARTHRITIS (frozen shoulder) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant medication not reported.   The patient got frozen shoulder because a dose of the Moderna Covid-19 vaccine was given too high. He had a Physician recommend that he receive the Spikevax 2023 2024 vaccine in his thigh.  Treatment medication not reported.  Company comment- This is a spontaneous case concerning a male patient of an unknown age with no reported medical history, who experienced the non-serious unexpected AESI periarthritis on an unknown date after a dose of SPIKEVAX NOS vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. It was reported patient got frozen shoulder because a dose of the Moderna COVID-19 vaccine was given too high. No further details were provided for medical review. The benefit-risk relationship of SPIKEVAX NOS vaccine is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Urinary tract infection, Urine analysis
Clinical narrative: she had a feeling that she had a UTI; This spontaneous case was reported by a consumer and describes the occurrence of URINARY TRACT INFECTION (she had a feeling that she had a UTI) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch nos. 8058081 and AS7185B) for COVID-19 vaccination.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:high cholesterol on Welchol, mild SVT mild Flecainade acetate, osteoporosis (officially diagnosed last year or early this year, previously osteopenia) started on Alendronate - previously osteopenia.  Previously administered products included for Drug use for unknown indication: Moderna (1st Dose: lot number 024M20A) on 08-Mar-2021, Moderna (2nd Dose: lot number 013A21A) on 05-Apr-2021, Moderna (3rd Dose: lot number 017F21A) on 25-Oct-2021, Moderna (4th Dose: lot number 058A22-2A) on 04-Jun-2022, Moderna (5th Dose: lot number 055F22B) on 03-Oct-2022 and Flu vacc on 26-Sep-2023. Past adverse reactions to the above products included No adverse reaction with Flu vacc, Moderna, Moderna, Moderna, Moderna and Moderna. Concurrent medical conditions included Hypercholesterolaemia, Supraventricular tachycardia and Osteoporosis.   On 11-May-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 05-Nov-2023, received seventh dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) dosage was changed to 1 dosage form. On 08-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced URINARY TRACT INFECTION (she had a feeling that she had a UTI). The patient was treated with SULFAMETHOXAZOLE on 08-Nov-2023 for UTI, at a dose of 1 dosage form every twelve hours. At the time of the report, URINARY TRACT INFECTION (she had a feeling that she had a UTI) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Nov-2023, Urine analysis: diagnosed to have UTI.     For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  On 07-Nov-2023 to 08-Nov-2023, the patient had a feeling that she had a UTI. She started taking treatment, but she recalled that when she took the previous vaccines, she was told not to take any medication for headache or any antibiotic. The patient asked if there have been studies that show that the effect of the Spikevax can be nullified by the antibiotic that she was currently taking.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: sore arm; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.     Concurrent medical conditions included Immune system disorder.    On 08-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 09-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not reported.  Patient had an immune deficiency and has taken previous Moderna vaccines and has had severe side effects with each one for 36 hours. Symptoms reported have She states that she felt horrific. She received Spikevax and felt nothing except a sore arm. In the past she has shown that she didn't maintain antibodies.  Treatment information was not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-748891 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-748891:Same Patient, Different dose
Age: 0.33
Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered, No adverse event, Product preparation error
Clinical narrative: PENTACEL being administered as two separate doses. Caller states the DTap/IPV portion was administered to the patient, however it was not reconstituted with the ActHib lyophilized portion with no reported adverse event; Initial information received on 30-Oct-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 5 months old female patient who was being administered Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine [Pentacel (VERO)] as two separate doses. caller states the dtap/ipv portion was administered to the patient, however it was not reconstituted with the acthib lyophilized portion with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 20V (CRM197) (PREVNAR 20) for Immunisation.  On 30-Oct-2023, the patient received a 0.5 ml dose of suspect Diphtheria/Tetanus/5 Hybrid AC Pertussis/IPV(VERO)/HIB(PRP/T) Vaccine Suspension for injection (lot UJ851AA, expiry date: 01-Apr-2024 with unknown strength) via intramuscular route in the thigh nos as Immunization as two separate doses. caller states the dtap/ipv portion was administered to the patient, however it was not reconstituted with the acthib lyophilized portion with no reported adverse event (single component of a two-component product administered) (Latency: same day).  It was reported "She would like to know if the lyophilized ActHib portion can be reconstituted with normal saline and administered to the patient? She would like to know if the 0.4% saline solution can be any they have on hand or does it have to be specific?"   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: 80.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Asthma, COVID-19, SARS-CoV-2 test
Clinical narrative: asthma; Then she attended a wedding, and she picked up COVID. Her COVID test came positive; This spontaneous case was reported by a patient and describes the occurrence of ASTHMA (asthma) and COVID-19 (Then she attended a wedding, and she picked up COVID. Her COVID test came positive) in an 80-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 061F22A) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE for an unknown indication.    No Medical History information was reported.   On 08-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient received dose of INFLUENZA VACCINE (unknown route) at an unspecified dose. On an unknown date, the patient experienced ASTHMA (asthma) and COVID-19 (Then she attended a wedding, and she picked up COVID. Her COVID test came positive). The patient was treated with CIPROFLOXACINE [CIPROFLOXACIN] at an unspecified dose and frequency. At the time of the report, ASTHMA (asthma) was resolving and COVID-19 (Then she attended a wedding, and she picked up COVID. Her COVID test came positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Patient had her first Moderna vaccine in Feb, then Mar and May. The new vaccine she believes is called Spikevax. She was going to take the Spikevax. She already took her flu vaccine. She did have fever, sore throat, cough, and asthma. She started taking Cipro and felt better. Then she attended a wedding, and she picked up COVID. Her COVID test came positive.
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dizziness, Fall, Head injury, Syncope
Clinical narrative: Patient was with mom. Received the vaccination and was fine got up and after a few minutes as walking away from the pharmacy felt light-headed and fainted. Came back to consciousness immediately after falling and hitting head on the ground. We iced her head and gave water. We counselled to seek medical attention if not feeling well and the proceeded to leave the pharmacy area.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: Extra dose administered; This non-serious case was reported by a physician via other manufacturer and described the occurrence of extra dose administered in a 1-year-old male patient who received DTPa-HBV-IPV (Pediarix) for prophylaxis.   Concomitant products included POLIO VACCINE (IPOL (POLIO VACCINE)).   On 28-SEP-2023, the patient received Pediarix. On 28-SEP-2023, an unknown time after receiving Pediarix, the patient experienced extra dose administered (Verbatim: Extra dose administered). The outcome of the extra dose administered 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: 3-NOV-2023  The reporter stated that the patient received a 2nd dose of IPOL, and they made a mistake of double dosing ipv to patient by administering a dose of Pediarix. The reporter consented to follow up. The patient received double dose of IPV which led to extra dose administered.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Illness, Incomplete course of vaccination, Influenza, Mobility decreased
Clinical narrative: really sick; feeling crummy; flu symptoms; she did not get her 2nd dose of Shingrix; she had a sore arm; was in bed for 2 days; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 23-MAY-2018, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 23-MAY-2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm (Verbatim: she had a sore arm). On an unknown date, the patient experienced bedridden (Verbatim: was in bed for 2 days), sickness (Verbatim: really sick), feeling bad (Verbatim: feeling crummy), flu symptoms (Verbatim: flu symptoms) and incomplete course of vaccination (Verbatim: she did not get her 2nd dose of Shingrix). The outcome of the pain in arm, sickness, feeling bad and flu symptoms were resolved and the outcome of the bedridden was resolved (duration 2 days) and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm, bedridden, sickness, feeling bad and flu symptoms to be related to Shingrix.     It was unknown if the company considered the pain in arm, bedridden, sickness, feeling bad and flu symptoms to be related to Shingrix.   Additional Information: GSK receipt date: 31-OCT-2023 The patient self-reported this case. The patient reported that she received the 1st dose of Shingrix, she thought in her left arm but was not sure, according to the pharmacy records and thought she had a sore arm that same afternoon and was in bed for 2 days really sick and felt crummy, with flu symptoms that started the morning after receiving the vaccine. The patient also reported that she received Zostavax, on 20-OCT-2021, according to the pharmacy records, but that her physician told her these dates were backwards.  The patient also felt the dates were backwards, as she remembered felt sick from Shingrix on her birthday, which would make the Shingrix vaccine the one received on 20-OCT-2021. The patient had used the dates in the pharmacy records in this report.  The patient could not obtain records from the pharmacy to verify this, as it against law to obtain them.  The patient also reported she did not get her 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. Patient also reported that she received a Covid Booster a week ago in Oct-2023 (from the date of reporting) and a Flu vaccine last week in Oct-2023 (from the date of reporting) both unknown product information. The patient had no lot/expiry information or route of administration information to provide. The consent to follow up granted.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: really sick; feeling crummy; flu symptoms; she did not get her 2nd dose of Shingrix; she had a sore arm; was in bed for 2 days; This non-serious case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 23-MAY-2018, the patient received the 1st dose of Shingrix (unknown arm). On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 23-MAY-2018, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced pain in arm (Verbatim: she had a sore arm). On an unknown date, the patient experienced bedridden (Verbatim: was in bed for 2 days), sickness (Verbatim: really sick), feeling bad (Verbatim: feeling crummy), flu symptoms (Verbatim: flu symptoms) and incomplete course of vaccination (Verbatim: she did not get her 2nd dose of Shingrix). The outcome of the pain in arm, sickness, feeling bad and flu symptoms were resolved and the outcome of the bedridden was resolved (duration 2 days) and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the pain in arm, bedridden, sickness, feeling bad and flu symptoms to be related to Shingrix.     It was unknown if the company considered the pain in arm, bedridden, sickness, feeling bad and flu symptoms to be related to Shingrix.   Additional Information: GSK receipt date: 31-OCT-2023 The patient self-reported this case. The patient reported that she received the 1st dose of Shingrix, she thought in her left arm but was not sure, according to the pharmacy records and thought she had a sore arm that same afternoon and was in bed for 2 days really sick and felt crummy, with flu symptoms that started the morning after receiving the vaccine. The patient also reported that she received Zostavax, on 20-OCT-2021, according to the pharmacy records, but that her physician told her these dates were backwards.  The patient also felt the dates were backwards, as she remembered felt sick from Shingrix on her birthday, which would make the Shingrix vaccine the one received on 20-OCT-2021. The patient had used the dates in the pharmacy records in this report.  The patient could not obtain records from the pharmacy to verify this, as it against law to obtain them.  The patient also reported she did not get her 2nd dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. Patient also reported that she received a Covid Booster a week ago in Oct-2023 (from the date of reporting) and a Flu vaccine last week in Oct-2023 (from the date of reporting) both unknown product information. The patient had no lot/expiry information or route of administration information to provide. The consent to follow up granted.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, No adverse event
Clinical narrative: Possible late 2nd dose of Shingrix on an unknown date; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (on an date received 1st dose).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Possible late 2nd dose of Shingrix on an unknown date). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date:01-NOV-2023 The reporter reported that possible late 2nd dose of Shingrix. No other adverse event information made available. The vaccine administration facility was the same as primary reporter. Sales representative information emailed to safety team. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 1.58
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: patient received dose two of Havrix 4 months after dose one instead of 6 months after dose one; This non-serious case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 1-year-old male patient who received HAV (Havrix) (batch number 95R7C, expiry date 05-MAY-2025) for prophylaxis.   Previously administered products included Havrix (On 26th June 2023, received one dose).   On 31-OCT-2023, the patient received Havrix. On 31-OCT-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: patient received dose two of Havrix 4 months after dose one instead of 6 months after dose one). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK Receipt Date: 02-NOV-2023 The nurse reported that the patient received dose two of Havrix 4 months after the dose one instead of 6 months after dose one. Lot number and expiration date for first dose was not provided.  No additional information were reported. The reporter consented to follow up. The patient received booster dose of Havrix vaccine, earlier than the recommended interval, which led to shortening of vaccinations schedule.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Neck pain, Pain in extremity
Clinical narrative: arm was a little bit sore; vomiting; nausea; Neck pain; severe headache; chills; fever; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (Neck pain), PAIN IN EXTREMITY (arm was a little bit sore), HEADACHE (severe headache), CHILLS (chills) and PYREXIA (fever) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058856) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 23-Oct-2023 at 8:00 PM, the patient experienced NECK PAIN (Neck pain), HEADACHE (severe headache), CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was a little bit sore), VOMITING (vomiting) and NAUSEA (nausea). At the time of the report, NECK PAIN (Neck pain), PAIN IN EXTREMITY (arm was a little bit sore), HEADACHE (severe headache), CHILLS (chills) and PYREXIA (fever) had not resolved and VOMITING (vomiting) and NAUSEA (nausea) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient's vaccinations details were as follows: Moderna COVID-19 vaccine on: Dose 1 1MAR2021, 002A21A, Dose 2 30MAR2021, 028A21A, Dose 3 28OCT2021, 076C21A, Dose 4 10JUN2022, 054A22A.  The patient's arm was a little bit sore and had some neck pain. Around 8:00 PM the patient had a severe headache, severe neck ache, chills, fever. Sick all night and couldn't take care of her animals. Also had vomiting, nausea. These symptoms lasted 24 hours before resolving. Patient used a heating pad on head, but had no medications to help with her symptoms.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: arm was a little bit sore; vomiting; nausea; Neck pain; severe headache; chills; fever; This spontaneous case was reported by a patient and describes the occurrence of NECK PAIN (Neck pain), PAIN IN EXTREMITY (arm was a little bit sore), HEADACHE (severe headache), CHILLS (chills) and PYREXIA (fever) in a 72-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058856) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 23-Oct-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 23-Oct-2023 at 8:00 PM, the patient experienced NECK PAIN (Neck pain), HEADACHE (severe headache), CHILLS (chills) and PYREXIA (fever). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was a little bit sore), VOMITING (vomiting) and NAUSEA (nausea). At the time of the report, NECK PAIN (Neck pain), PAIN IN EXTREMITY (arm was a little bit sore), HEADACHE (severe headache), CHILLS (chills) and PYREXIA (fever) had not resolved and VOMITING (vomiting) and NAUSEA (nausea) had resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant and treatment medications were not reported.  The patient's vaccinations details were as follows: Moderna COVID-19 vaccine on: Dose 1 1MAR2021, 002A21A, Dose 2 30MAR2021, 028A21A, Dose 3 28OCT2021, 076C21A, Dose 4 10JUN2022, 054A22A.  The patient's arm was a little bit sore and had some neck pain. Around 8:00 PM the patient had a severe headache, severe neck ache, chills, fever. Sick all night and couldn't take care of her animals. Also had vomiting, nausea. These symptoms lasted 24 hours before resolving. Patient used a heating pad on head, but had no medications to help with her symptoms.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: Wrong product administered
Clinical narrative: incorrect vaccine administered
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Oral discomfort, Paraesthesia oral
Clinical narrative: My lips started tingling/burning a few days after the receiving the RSV vaccine.  The condition wasn?t terrible but it was bothersome.  It helped using lip balm. The condition has very slowly improved but has still not gone away. BTW I didn?t know which RSV vaccine I received so I just picked one of the ones listed above.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal disorder, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Starting the morning after vaccination patient reports injection arm pain, stiffness, and loss of function that has not subsided. No visible injury or redness. She had been to two doctors and both prescribed steroids. No imaging was done yet based on patient report.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: No adverse event
Clinical narrative: no symptoms after the vaccines
Sex: F
Vaccine: COVID19, RSV
Symptoms: Asthenia, Cold sweat, Decreased appetite, International normalised ratio, International normalised ratio increased
Clinical narrative: Resident received RSV and COVID 2023-2024 vaccine on 10/25/2023. Began baclofen 10mg three times daily at that time as well. Resident could not assist with transfers on 10/27/2023 and complained of nausea and weakness, appeared lethargic. Seemed to improve after 2 or 3 days. PT/INR checked on 11/6/2023 and showed >8. Resident's normal is between 1.5 and 2 and had been in this range for several months. PT/INR checked again on 11/7/2023 and was > 10 after holding coumadin. Resident became lethargic on 11/5/2023 and lost appetite. Continued w/difficulty transferring. On 11/7/2023, became pale and clammy with hot skin, afebrile. Sent to ER and admitted to hospital.
Sex: F
Vaccine: COVID19, RSV
Symptoms: Lethargy, Mobility decreased, Nausea, Pallor, Prothrombin time
Clinical narrative: Resident received RSV and COVID 2023-2024 vaccine on 10/25/2023. Began baclofen 10mg three times daily at that time as well. Resident could not assist with transfers on 10/27/2023 and complained of nausea and weakness, appeared lethargic. Seemed to improve after 2 or 3 days. PT/INR checked on 11/6/2023 and showed >8. Resident's normal is between 1.5 and 2 and had been in this range for several months. PT/INR checked again on 11/7/2023 and was > 10 after holding coumadin. Resident became lethargic on 11/5/2023 and lost appetite. Continued w/difficulty transferring. On 11/7/2023, became pale and clammy with hot skin, afebrile. Sent to ER and admitted to hospital.
Sex: F
Vaccine: COVID19, RSV
Symptoms: Skin warm
Clinical narrative: Resident received RSV and COVID 2023-2024 vaccine on 10/25/2023. Began baclofen 10mg three times daily at that time as well. Resident could not assist with transfers on 10/27/2023 and complained of nausea and weakness, appeared lethargic. Seemed to improve after 2 or 3 days. PT/INR checked on 11/6/2023 and showed >8. Resident's normal is between 1.5 and 2 and had been in this range for several months. PT/INR checked again on 11/7/2023 and was > 10 after holding coumadin. Resident became lethargic on 11/5/2023 and lost appetite. Continued w/difficulty transferring. On 11/7/2023, became pale and clammy with hot skin, afebrile. Sent to ER and admitted to hospital.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure increased, Hyperhidrosis, Hypersensitivity, Palpitations, Tremor
Clinical narrative: I received the latest COVID vaccine (Pfizer) at a Family Medicine clinic. Within 5 minutes of receiving the vaccine, I experienced an allergic reaction. My ear drums were tight, I had significant heart palpitations, the palms of my hands became very sweaty and I had major tremors. I have had 3 previous COVID vaccinations, all Pfizer, with no reaction. I doubt this was reported as the nurse practitioner said it might be anxiety. It was not anxiety, it was a reaction to the vaccine. The symptoms were exactly what occurs when I eat food that contains MSG. My O2 was normal but my blood pressure kept going up. I was given 50mg orally of Benadryl and the symptoms subsided within 30-45 min.
Sex: F
Vaccine: COVID19
Symptoms: Tympanic membrane disorder
Clinical narrative: I received the latest COVID vaccine (Pfizer) at a Family Medicine clinic. Within 5 minutes of receiving the vaccine, I experienced an allergic reaction. My ear drums were tight, I had significant heart palpitations, the palms of my hands became very sweaty and I had major tremors. I have had 3 previous COVID vaccinations, all Pfizer, with no reaction. I doubt this was reported as the nurse practitioner said it might be anxiety. It was not anxiety, it was a reaction to the vaccine. The symptoms were exactly what occurs when I eat food that contains MSG. My O2 was normal but my blood pressure kept going up. I was given 50mg orally of Benadryl and the symptoms subsided within 30-45 min.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: tested positive for Covid-19; tested positive for Covid-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A 42-year-old patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 13Oct2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "never smoked" (unspecified if ongoing), notes: I have never smoked. The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant) all with onset 27Oct2023, outcome "unknown" and all described as "tested positive for Covid-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (27Oct2023) Positive, notes: tested positive for Covid-19 with an at home test kit.  Additional information: Patient received the Pfizer vaccine on Friday, 13Oct2023 at local (clinic name). Patient became sick and tested positive for Covid-19 with an at home test kit on Friday, 27Oct2023. Patient was 42 years of age and healthy. Patient have never smoked, do not drink and take safety precautions such as masking and social distancing.   The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; VARIVAX was administered during a T/E; This spontaneous report was received from a certified nurse midwife referring to a 5-year-old female patient.  No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies, or concomitant medications.  On 13-OCT-2023, the varicella virus vaccine live (oka/merck) (VARIVAX) lot# X010525 underwent a temperature excursion of 12.5 Fahrenheit degree for 25 minutes.  On 16-OCT-2023, the patient was vaccinated with the varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 1 dose, lot #X010525, expiration date: 11-APR-2025, administered subcutaneously in the left arm for prophylaxis (strength was not provided) that underwent temperature excursion before viability determination. No additional adverse event was reported.  Subsequently, varicella virus vaccine live (oka/merck) (VARIVAX) was determined viable.
Sex: U
Vaccine: VARZOS
Symptoms: Deafness neurosensory, Sudden hearing loss
Clinical narrative: sudden sensorineural hearing loss; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient (pt) of unknown age and gender. No information was provided regarding concomitant medications, concurrent conditions or medical history.   Around 30-OCT-2015, the pt. was inoculated with the zoster vaccine live (ZOSTAVAX) vaccine at a health department as recommended for routine adult health maintenance and for the prevention of shingles (dose, route, and lot # not provided).   Shortly after receiving zoster vaccine live (ZOSTAVAX), pt. suffered sudden sensorineural hearing loss (Deafness neurosensory) (date unspecified).  As a direct and proximate result of zoster vaccine live (ZOSTAVAX)vaccine, and/or despite receiving zoster vaccine live (ZOSTAVAX) for long-term prevention of shingles, the pt suffered have resulted in physical limitations, mental and emotional distress due to resulting physical limitations and seriousness of his condition.  As a result of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of the Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the event was unknown. The event were considered related to zoster vaccine live (ZOSTAVAX).  Upon internal review sensorineural hearing loss (Deafness neurosensory) was considered to be medically significant.  Suffered sudden sensorineural hearing loss (Deafness neurosensory) was considered to be disabling by the reporter.
Age: 5.0
Sex: F
Vaccine: FLUN4
Symptoms: Pyrexia
Clinical narrative: 103.7 F FEVER; A spontaneous report has been received from a consumer concerning a female patient (age 5 years).    No medical history was reported. Concomitant medication included influenza vaccine live reassort 3v.     On an unknown date, the patient received Flumist Quadrivalent (influenza vaccine live reassort 4v) (batch number Unknown) unknown, via nasal route.     A Unknown administered FLUMIST QUADRIVALENT. No malfunction has been reported for this combination product.    On 02-Nov-2023, the patient experienced 103.7 f fever (preferred term: Pyrexia).     Action taken with suspect Flumist Quadrivalent was Not Applicable.    On 03-Nov-2023, the patient recovered from the event 103.7 f fever.     The event of 103.7 f fever was upgraded by the company physician from non-serious to serious due to seriousness criteria of important medical event.    Laboratory values are available.    Device Information:     Combination Product Report: Yes    Product As Reported: FLUMIST QUADRIVALENT  Common Device Name: Nasal Spray  Procode: CCQ  Product Role: Suspect; Sender's Comments: Pyrexia is not listed in the company core data sheet of Q/LAIV. Due to limited information on indication, action taken, start date, circumstances leading to the event, concurrent conditions, concomitant medications, relevant medical history, risk factors leading to the event (infectious diseases), detailed etiological and diagnostic workup (complete blood analysis including infectious disease profile, relevant imaging studies), the evaluation did not find evidence to suggest a reasonable possibility of a causal relationship between the event and Q/LAIV.
Sex: M
Vaccine: FLU4
Symptoms: Acne, Oral herpes
Clinical narrative: Pimple like spots on lips, cheeks, chin and chest; cold sores; This non-serious case was reported by a consumer via sales rep and described the occurrence of pimples in a adult male patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) (batch number MC355, expiry date 30-JUN-2024) for prophylaxis.   On 25-OCT-2023, the patient received FluLaval Quadrivalent (right deltoid). On 28-OCT-2023, 3 days after receiving FluLaval Quadrivalent, the patient experienced pimples (Verbatim: Pimple like spots on lips, cheeks, chin and chest) and cold sores (Verbatim: cold sores). On 29-OCT-2023, the outcome of the pimples was resolved (duration 1 day). The outcome of the cold sores was not resolved.   It was unknown if the reporter considered the pimples and cold sores to be related to FluLaval Quadrivalent.     It was unknown if the company considered the pimples and cold sores to be related to FluLaval Quadrivalent.   Additional Information: GSK Receipt Date: 01-NOV-2023 It was reported that patient had Pimple like spots on lips, cheeks, chin and chest. All pimples flared up for about 24 hours but then went away with the exception of 4 on the lip which acted similar to cold sores.
Sex: U
Vaccine: RSV, VARZOS
Symptoms: Headache, Influenza, Injection site rash, Pain
Clinical narrative: Headache; Flu symptoms; aches and pain; Rash very bad on upper left arm; Temperature; This non-serious case was reported by a consumer via other manufacturer and described the occurrence of headache in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included RSV VACCINE PROT. SUBUNIT PREF 2V (ABRYSVO) for prophylaxis.   On an unknown date, the patient received Shingles vaccine (left arm) and ABRYSVO (left arm). On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced headache (Verbatim: Headache), flu symptoms (Verbatim: Flu symptoms), pain (Verbatim: aches and pain), rash (Verbatim: Rash very bad on upper left arm) and fever (Verbatim: Temperature). The outcome of the headache, flu symptoms, pain, rash and fever were resolving.   It was unknown if the reporter considered the headache, flu symptoms, pain, rash and fever to be related to Shingles vaccine.     It was unknown if the company considered the headache, flu symptoms, pain, rash and fever to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 31-OCT-2023 The patient reported he/she got the shingles and ABRYSVO (RSV VACCINE PROT. SUBUNIT PREF 2V) vaccine on same arm. The patient had temperature, flu symptoms, aches and pain, headache and rash. Rash on upper left which was very bad. The patient stated it took a week to feel better. The pharmacist had to write a report. The patient never reacted before for a vaccinations. It was unknown if the reporter considered the headache, flu symptoms, pain, rash and body temperature to be related to ABRYSVO (RSV VACCINE PROT. SUBUNIT PREF 2V) vaccine.    The follow-up could not be possible as no contact details were available.