chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis, Vaccination site cellulitis
Clinical narrative: experienced localized cellulitis after vaccination; Initial information received on 01-Dec-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case is linked to case 2023SA378450(CLUSTER).  This case involves a 2 years old female patient who experienced localized cellulitis after vaccination of influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Nov-2023, the patient received 0.5ml  dose of suspect  influenza quadrival A-B vaccine, Suspension for injection (Lot Number:UT8219KA,Expiration Date :30-JUN-2024, Strength not reported) via intramuscular route in the right thigh for Immunization.  On an unknown date the patient developed  localized cellulitis after vaccination (vaccination site cellulitis) (unknown latency).  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the event (experienced localized cellulitis after vaccination).  At time of reporting, the outcome was Recovering / Resolving for the event experienced localized cellulitis after vaccination.
Age: 36.0
Sex: F
Vaccine: TYP
Symptoms: Expired product administered
Clinical narrative: administering an expired TYPHIM VI to a patient with no reported adverse event; Initial information received on 01-Dec-2023 regarding an unsolicited valid non-serious case received via other health professional.  This case involves a 36-year-old female patient, administering an expired typhoid VI polysaccharide vaccine [Typhim VI] to a patient with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 01-Dec-2023, the patient received 0.5 ml total dose of suspect typhoid VI polysaccharide vaccine, Solution for injection (strength: unknown) (lot: U2A471M, expiry date: 02-Nov-2023) via intramuscular route in the left deltoid for immunization and administering an expired typhim vi to a patient with no reported adverse event (expired product administered) (latency: same day).     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 and Regulatory Authority 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: 1.0
Sex: F
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, Exposure via skin contact, No adverse event, Underdose
Clinical narrative: medication leaked on the patient with no reported adverse event; patient and half of it ended up on the patient's leg with no reported adverse event; half of it ended up on the patient's leg with no reported adverse event; Initial information received on 01-Dec-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 1 years old female patient on whom Influenza Quadrival A-B Vaccine [Fluzone QIV] medication leaked and half of it ended up on the patient's leg 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 DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for Prophylactic vaccination; HIB VACCINE (HIB) for Prophylactic vaccination; and PNEUMOCOCCAL VACCINE (PNEUMOCOCCAL VACCINE) for Prophylactic vaccination.  On 01-Dec-2023, the patient was receiving a dose 1 with dosage 0.5 ml of suspect Influenza Quadrival A-B Vaccine Suspension for injection (lot U800CA, Expiry date: 30-Jun-2024 with strength unknown) via intramuscular route in right leg as immunization which leaked on the patient and half of it ended up on the patient's leg with no reported adverse event (incorrect dose administered) (accidental exposure to product) (exposure via skin contact) (Latency: same day).  It was reported "The nurse is asking if the patient needs to get a second dose. The nurse reported that while she was injecting, the patient moved away and the medication leaked on the patient. The nurse stated that she cleaned it up with an alcohol swab and wiped the patient. The nurse was not sure if the patient received half or less than half of the dose."   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: 63.0
Sex: F
Vaccine: FLUC3
Symptoms: Alopecia
Clinical narrative: Hair started to fall out after and every time I wash my hair I lose a bunch of hair/Hair keeps falling in extreme amounts; This spontaneous case was received on 27-Nov-2023 from other non-healthcare professional (consumer) via Communications (reference number: SEQW23-04509) and concerned a 63-year-old, female patient.  The patient had no medical history. The patient's concomitant medications included Crestor (rosuvastatin calcium), used for an unreported indication.  On 28-Oct-2023, the patient was vaccinated with Flucelvax Quadrivalent (influenza vaccine inact sag 4v; dose: 0.5 ml; route of administration, anatomical location: not reported) for influenza immunization for patient over 6 months of age and older. The batch number was not reported.  On 30- Oct-2023, two days after receiving Flucelvax Quadrivalent, the patient's hair started to fall out and every time after hair wash the patient lost a bunch of hair.  At the time of initial reporting, the patient had not recovered from the event. As reported, the hair kept falling in extreme amounts.   The reporter did not provide a causality assessment. As reported, the patient needed to know if this was a side effect of the vaccine.   The case was assessed as non-serious.  Company comment: A 63-year-old female patient experienced alopecia two days after the vaccination with Flucelvax Quadrivalent. Reportedly, the patient's hair kept falling in extreme amounts. Relevant laboratory and diagnostic data were not provided. Due to lack of above-mentioned information, causality for the reported event of alopecia is unassessable.; Sender's Comments: A 63-year-old female patient experienced alopecia two days after the vaccination with Flucelvax Quadrivalent. Reportedly, the patient's hair kept falling in extreme amounts. Relevant laboratory and diagnostic data were not provided. Due to lack of above-mentioned information, causality for the reported event of alopecia is unassessable.
Sex: F
Vaccine: FLU4
Symptoms: Alopecia
Clinical narrative: Hair started falling out in a much larger quantity than usual, and since then, it has been getting progressively worse; This spontaneous case was received on 27-Nov-2023 from other non-healthcare professional (consumer) via CSL Seqirus Adverse Event Reporting (reference number: 148503) and concerned a 63-year-old, female patient.   The patient's medical history was not reported. The patient's concomitant medications included Crestor (rosuvastatin calcium) for an unreported indication.   On 28-Oct-2023, the patient was vaccinated with Afluria Quadrivalent (influenza vaccine inact split 4v; dose, route of administration, anatomical location, and indication: not reported). The batch number was not reported.    On 30-Oct-2023, two days after receiving Afluria Quadrivalent, while washing her hair, the patient noticed that her hair started falling out in a much larger quantity than usual, and since then, it has been getting progressively worse. As reported, the patient was afraid that she might go bald. The patient had spoken to her doctor, and she was scheduled to undergo some blood tests.   At the time of initial reporting, the patient had not recovered from the event of 'hair loss'.   The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: A 63-year-old, female patient experienced hair loss 2 days after being vaccinated with Afluria Quadrivalent. Reportedly, the patient noticed that her hair started falling out in a much larger quantity than usual, and since then, it has been getting progressively worse. The patient's medical history was not reported. Although temporal relationship is plausible, vaccines are not normally considered a cause for unexpected loss of hair, therefore the event of alopecia is unassessable due to limited information provided.; Sender's Comments: A 63-year-old, female patient experienced hair loss 2 days after being vaccinated with Afluria Quadrivalent. Reportedly, the patient noticed that her hair started falling out in a much larger quantity than usual, and since then, it has been getting progressively worse. The patient's medical history was not reported. Although temporal relationship is plausible, vaccines are not normally considered a cause for unexpected loss of hair, therefore the event of alopecia is unassessable due to limited information provided.
Age: 73.0
Sex: M
Vaccine: RSV
Symptoms: Erythema, Pruritus, Skin warm
Clinical narrative: Large red spot on arm and very itchy. Red spot was hot.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Rash, Skin warm
Clinical narrative: Rashing across stomach, chest. Upper arms, neck and groin.  Not ichy, but affected areas are very warm to touch.
Sex: U
Vaccine: RSV
Symptoms: Back pain, Dizziness
Clinical narrative: dizziness; back pain; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a 66-year-old patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced dizziness (Verbatim: dizziness) and back pain (Verbatim: back pain). The outcome of the dizziness and back pain were not reported.   It was unknown if the reporter considered the dizziness and back pain to be related to Arexvy.     It was unknown if the company considered the dizziness and back pain to be related to Arexvy.   Additional Information: GSK Receipt Date: 29-NOV-2023 This case was reported by a patient via (Open field AE monitoring) interactive digital media. The patient had the RSV vaccine (Arexvy) and had some side effects, including dizziness and back pain. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: RSV
Symptoms: Bronchitis, Cough, Malaise, Pyrexia, Respiratory symptom
Clinical narrative: bronchitis; low grade fever; runny nose; sneezing; Cough; she experienced upper respiratory symptoms,; very sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of bronchitis in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included doxycycline.   On 08-NOV-2023, the patient received Arexvy (left arm). In NOV-2023, an unknown time after receiving Arexvy, the patient experienced bronchitis (Verbatim: bronchitis), low grade fever (Verbatim: low grade fever), runny nose (Verbatim: runny nose), sneezing (Verbatim: sneezing), cough (Verbatim: Cough), upper respiratory symptom (Verbatim: she experienced upper respiratory symptoms,) and sickness (Verbatim: very sick). The patient was treated with prednisone. In NOV-2023, the outcome of the sickness was resolved (duration 3 weeks). The outcome of the bronchitis, low grade fever, runny nose, sneezing, cough and upper respiratory symptom were unknown.   It was unknown if the reporter considered the bronchitis, low grade fever, runny nose, sneezing, cough, upper respiratory symptom and sickness to be related to Arexvy.     It was unknown if the company considered the bronchitis, low grade fever, runny nose, sneezing, cough, upper respiratory symptom and sickness to be related to Arexvy.   Additional Information: GSK Receipt date: 29-NOV-2023 Reporter was a patient. Patient received Arexvy vaccine and after getting dose, she experienced upper respiratory symptoms, cough, sneezing, runny nose, low grade fever, and bronchitis. Patient's doctor gave her prednisone and bronchitis for her symptoms. Patient was very sick for 3 weeks. Reporter did not consent to follow up.
Sex: F
Vaccine: RSV
Symptoms: Rhinorrhoea, Sneezing
Clinical narrative: bronchitis; low grade fever; runny nose; sneezing; Cough; she experienced upper respiratory symptoms,; very sick; This non-serious case was reported by a consumer via call center representative and described the occurrence of bronchitis in a female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concomitant products included doxycycline.   On 08-NOV-2023, the patient received Arexvy (left arm). In NOV-2023, an unknown time after receiving Arexvy, the patient experienced bronchitis (Verbatim: bronchitis), low grade fever (Verbatim: low grade fever), runny nose (Verbatim: runny nose), sneezing (Verbatim: sneezing), cough (Verbatim: Cough), upper respiratory symptom (Verbatim: she experienced upper respiratory symptoms,) and sickness (Verbatim: very sick). The patient was treated with prednisone. In NOV-2023, the outcome of the sickness was resolved (duration 3 weeks). The outcome of the bronchitis, low grade fever, runny nose, sneezing, cough and upper respiratory symptom were unknown.   It was unknown if the reporter considered the bronchitis, low grade fever, runny nose, sneezing, cough, upper respiratory symptom and sickness to be related to Arexvy.     It was unknown if the company considered the bronchitis, low grade fever, runny nose, sneezing, cough, upper respiratory symptom and sickness to be related to Arexvy.   Additional Information: GSK Receipt date: 29-NOV-2023 Reporter was a patient. Patient received Arexvy vaccine and after getting dose, she experienced upper respiratory symptoms, cough, sneezing, runny nose, low grade fever, and bronchitis. Patient's doctor gave her prednisone and bronchitis for her symptoms. Patient was very sick for 3 weeks. Reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: patient received 3 doses of Shingrix; Inappropriate schedule of vaccine; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose of Shingrix on 13-MAR-2018).   On 04-AUG-2023, the patient received the 3rd dose of Shingrix. On 17-MAY-2019, the patient received the 2nd dose of Shingrix. On 17-MAY-2019, not applicable after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: Inappropriate schedule of vaccine). On 04-AUG-2023, the patient experienced extra dose administered (Verbatim: patient received 3 doses of Shingrix). The outcome of the extra dose administered and drug dose administration interval too long were unknown.   Additional Information: GSK receipt date: 29-NOV-2023 A physician assistant inquired about how to proceed after a patient received 3 doses of Shingrix. The reporter reported that the question was whether the patient needed an additional dose since it was not done 2-6 months between. The reporter literally just asked another representative this question and had to leave the work space. Reporter stated that the patient ended the chat, and no additional vaccine or patient details were available related to adverse event. No contact for health care professional. The reporter did not consent to follow up. The patient received 3 doses of Shingrix and from which received second dose of Shingrix later than the recommended interval, which led to lengthening of vaccine schedule and extra dose administered.
Sex: F
Vaccine: FLUX, TDAP
Symptoms: Feeling abnormal, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Pale skin; Sweating; Feeling funny; Lost consciousness; This serious case was reported by a physician via call center representative and described the occurrence of lost consciousness in a 34-year-old female patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE for prophylaxis.   On 01-DEC-2023, the patient received Boostrix (intramuscular) and INFLUENZA VACCINE (intramuscular). On 01-DEC-2023, less than a day after receiving Boostrix and an unknown time after receiving INFLUENZA VACCINE, the patient experienced lost consciousness (Verbatim: Lost consciousness) (serious criteria GSK medically significant), pale skin (Verbatim: Pale skin), sweating (Verbatim: Sweating) and weird feeling (Verbatim: Feeling funny). The outcome of the lost consciousness was resolved (duration 4 min) and the outcome of the pale skin, sweating and weird feeling were resolved.   It was unknown if the reporter considered the lost consciousness, pale skin, sweating and weird feeling to be related to Boostrix and Boostrix Pre-Filled Syringe Device.     It was unknown if the company considered the lost consciousness, pale skin, sweating and weird feeling to be related to Boostrix and Boostrix Pre-Filled Syringe Device.   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: 01-DEC-2023 The physician reported today (on the day of reporting) patient received Boostrix and an unspecified flu vaccine in her clinic today. The physician gave Boostrix first and waited for few minutes and then administered an unspecified flu vaccine. The patient lost consciousness for 4 minutes. The patient was sweaty and pale. She stated the patient felt funny after the Boostrix and before the flu vaccine but did not inform the physician. The emergency services was called but patient was not transported. The patient recovered in just a few minutes and felt well enough to go home. It was unknown if the reporter considered the lost consciousness, pale skin, sweating and weird feeling to be related to Influenza vaccine. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: localized cellulitis after vaccination; Initial information was received on 01-Dec-2023 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to cases 2023SA378450, 2023SA378449 and 2023SA378916 were (CLUSTER).  This case involves a 3 years old male patient who experienced localized cellulitis after vaccination with influenza quadrival A-B vaccine [Fluzone QIV].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 30-Oct-2023, the patient received a dose of 0.5 ml of suspect influenza quadrival A-B vaccine, Suspension for injection (lot UT8219KA, strength and expiry: unknown) via intramuscular route in the right thigh for Immunization.  On an unknown date the patient developed a non-serious localized cellulitis after vaccination (vaccination site cellulitis) (unknown latency).   Action taken was not applicable.  The patient received antibiotics for treatment.  At time of reporting, the outcome was Recovered / Resolved on an unknown date for the event localized cellulitis after vaccination.; Sender's Comments:  SAD20231201001630:
Sex: F
Vaccine: HEPAB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a Twinrix vaccine was administered to an 11-year-old patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 11-year-old female patient who received HAB (Twinrix) (batch number HSG9) for prophylaxis.   On 22-NOV-2023, the patient received Twinrix. On 22-NOV-2023, an unknown time after receiving Twinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: a Twinrix vaccine was administered to an 11-year-old patient). The outcome of the inappropriate age at vaccine administration 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 27 Nov 2023 Medical assistant reported a Twinrix vaccine was administered to an 11-year-old patient, which led to inappropriate age at vaccine administration. The reporter consented to follow up via email.
Age: 4.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: punctured IPOL was administered to two patients with no adverse event; Initial information received on 01-Dec-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case is linked to case 2023SA378578.  This case involves a 4 years old male patient who was administered punctured IPV (VERO) [IPOL] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DAPTACEL) for Prophylactic vaccination; and MEASLES VACCINE, MUMPS VACCINE, RUBELLA VACCINE (MMR) for Prophylactic vaccination.  On 14-Nov-2023, the patient received a 0.5 ml dose of punctured suspect IPV (VERO) suspension for injection (lot V1B901M, expiry date: 02-JUN-2024 with unknown strength) via intramuscular route in the deltoid nos as immunization that had Max/low temperature reached: 9.44 C Duration: 1 hour and 30 minutes on an unknown date with no adverse event (poor quality product administered) (unknown latency). Human error: No  It was reported "They had no idea but they suspect that the surrounding environment became too hot and it affected the temperature of their storage."   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 and Regulatory Authority 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: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site bruising, Injection site discolouration, Injection site discomfort, Injection site erythema, Injection site hypersensitivity
Clinical narrative: Allergic reaction to sight of injection raises knot with spreading redness, tender and extremely sore and discomforting , bruise   Now her skin is a little darker than normal where the redness was
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Allergic reaction to sight of injection raises knot with spreading redness, tender and extremely sore and discomforting , bruise   Now her skin is a little darker than normal where the redness was
Age: 76.0
Sex: M
Vaccine: PPV, RSV
Symptoms: Abnormal behaviour, Dysarthria, Speech disorder, Transient ischaemic attack
Clinical narrative: Mini stroke; difficulty talking, speaking very softly; This serious case was reported by a consumer via call center representative and described the occurrence of ministroke in a 76-year-old male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Co-suspect products included Pneumococcal vaccine for prophylaxis.   On 27-OCT-2023, the patient received the 1st dose of Arexvy (intramuscular, left deltoid) and Pneumococcal vaccine. On 29-OCT-2023, 2 days after receiving Arexvy, the patient experienced ministroke (Verbatim: Mini stroke) (serious criteria hospitalization, GSK medically significant and clinically significant/intervention required) and speech disorder (Verbatim: difficulty talking, speaking very softly) (serious criteria hospitalization and clinically significant/intervention required). On 04-NOV-2023, the outcome of the ministroke and speech disorder were resolved (duration 6 days).   It was unknown if the reporter considered the ministroke and speech disorder to be related to Arexvy.     It was unknown if the company considered the ministroke and speech disorder to be related to Arexvy.   Additional Information: GSK Receipt Date: 01-DEC-2023 The reporter was the spouse of the patient. The reporter stated her husband was given the Arexvy and Pneumonia vaccine at the same time. The patient started having difficulty taking, speaking very softly.  The spouse stated that this was out of character for the patient and then patient asked for her to take him to the hospital. The patient was admitted to the hospital on 29-OCT-2023 and was discharged on 04-NOV-2023 with a diagnosis of a mini-stroke. The patient symptoms resolved 04-NOV-2023 with no residual effects. It was unknown if the reporter considered the ministroke and speech disorder to be related to Pneumonia vaccine.    The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Chills, Dizziness, Headache, Nausea
Clinical narrative: LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.; LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.; LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.; LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.; This spontaneous case was reported by a nurse practitioner and describes the occurrence of CHILLS (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.), NAUSEA (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.), DIZZINESS (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.) and HEADACHE (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.) in a 68-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. ASKU) for COVID-19 prophylaxis.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On 04-Dec-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 04-Dec-2023, the patient experienced CHILLS (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.), NAUSEA (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.), DIZZINESS (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.) and HEADACHE (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.). At the time of the report, CHILLS (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.), NAUSEA (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.), DIZZINESS (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.) and HEADACHE (LPN states after vaccination he started having, Chills, Nausea, Dizziness and Headaches.) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  Treatment information was not provided.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Arthralgia, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: Onset of chills around 7pm. By 9pm aches in joints & exhaustion. By 10pm, fever of 101.5 oral. Took 1 Tylenol. 12pm fever still 101 & body feeling very achy.5, took 2 Ibuprofen. 6am the nest morning, drenched in perspiration, temp 99.7. Headach & exhausted.
Age: 51.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pyrexia
Clinical narrative: Onset of chills around 7pm. By 9pm aches in joints & exhaustion. By 10pm, fever of 101.5 oral. Took 1 Tylenol. 12pm fever still 101 & body feeling very achy.5, took 2 Ibuprofen. 6am the nest morning, drenched in perspiration, temp 99.7. Headach & exhausted.
Age: 67.0
Sex: F
Vaccine: COVID19, FLUX, RSV
Symptoms: Allergy test negative, Mobility decreased, Pruritus, Rash erythematous, Sleep disorder
Clinical narrative: Received plus 65 pneumonia vaccine at dr office on Sept 12, Sept 22 got RSV, Covid and flu vaccines at same time at pharmacy per pharmacists recommendation. Approximately 2 weeks later , developed serious generalized itching that started on shoulders, chest and arms and spread to entire body  . Skin developed faint light pink lacy rash with small bumps felt in random areas under the skin . Itcjing became so severe it was impossible to sleep, and difficult to function during the day . Saw- allergist on November 2nd who tested me for 50 allergens and all were negative .He ordered Claritan 10mg 4 times a day. Saw a dermatologist who ordered topical medication with limited relief . Symptoms lasted f October and November .  Eventually rash / itching improved and I was able to gradually discontinue Claritan . High daily dose of Claritan had caused me fatigue and concerning mental cloudiness . possibly worse due to my age(67) . Decemer 2 , itching started again and is worsening . Currently started daily Claritan and topicals with limited relief at this time , will probably need to increase frequency of claritan to obtain better relief. I am planning to schedule with PCP, dermatologist or allergist again for reevaluation . The Allergist felt that the combination of 3 vaccine may have been the cause , since I have received yearly flu and Covid vaccines as available , tho administered on different days, without any unusual ill effects.
Age: 52.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Amenorrhoea, Haemorrhagic disorder, Heavy menstrual bleeding, Muscle spasms, Oligomenorrhoea
Clinical narrative: Took Phizer covid vaccine booster 4th on 10.26.23 on first day of period with flu vac. I am 52. Period was extended from 7 days to 15 days. I had intense bleeding and gushing. I also had lost of pain. Blood would drip on the floor.  Cycle normally every 24 to 28 days. Have not had a Period since then only cramping. Today is December 6, 2023. This is true issue for many women. These side effects are bad for womenand the FDA should make these adverse effects know to everyone. An earlier Covid vaccine booster made my cycle by 6 weeks between periods. I took
Age: 6.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Adult dose administered to child under 12 years of age
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Adult dose administered to child under 12 years of age
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Immunisation reaction, Otitis media, Rash, Rash maculo-papular
Clinical narrative: Mother presented with child to urgent care setting initially on 12/6/23 with concerns for rash.  Rash started one day prior to that, 12/5, and initially present only on legs.  Within 24 hours, spread to rest of body; from scalp to toes.  Rash maculopapular in nature.  Not itchy.  Of note, Patient was taking amoxicillin at time of rash, which was started on 11/27/23 for otitis media.  Was told at urgent care that rash appeared to be reaction from MMR vaccine.  Patient was brought into pediatrics office (PCP) on 12/7/23 to re evaluate rash.  There was question as to whether rash was due to typical rash that can occur following MMR vaccine, vs. allergic reaction to component of vaccine.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Haemorrhagic stroke, Intensive care, Mental status changes
Clinical narrative: Adverse event:  intracranial hemorrhagic stroke (ICH).  Patient presented to the ER about 5 hours after PCP office visit where 2023 COVID vaccination was administered.  She presented to the ER with altered mental status and found to have ICH.  Patient was transferred to ICU and continues to be treated.
Age: 0.17
Sex: M
Vaccine: HIBV, HIBV, PNC20, PNC20
Symptoms: Grunting, Influenza A virus test negative, Influenza B virus test, Nasal flaring, Respiratory syncytial virus test negative
Clinical narrative: Per the mother of the patient, the patient had nasal flaring, slight retractions, and gunting. The patient was taken to the emergency room where he was tested for viral infections. Per the mother, all testing was negative. Mother of the patient states the patient is doing well now and is not experiencing these symtoms.
Age: 0.17
Sex: M
Vaccine: HIBV, HIBV, PNC20, PNC20
Symptoms: SARS-CoV-2 test negative
Clinical narrative: Per the mother of the patient, the patient had nasal flaring, slight retractions, and gunting. The patient was taken to the emergency room where he was tested for viral infections. Per the mother, all testing was negative. Mother of the patient states the patient is doing well now and is not experiencing these symtoms.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Blood thyroid stimulating hormone normal, C-reactive protein normal, Cardiac stress test normal, Chest X-ray normal, Electrocardiogram ambulatory abnormal
Clinical narrative: approx 2.5 weeks after vaccination, started having frequent ectopic heart beats (symptomatic Premature atrial complexes 21% of the time on Holter monitoring). This was similar to what happened following Moderna bivalent booster one year prior, symptomactic PACs up to 29% of the time and symptoms continuing through 2+ months post-vaccination
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Extrasystoles, Full blood count normal, Magnetic resonance imaging normal, Metabolic function test, Red blood cell sedimentation rate normal
Clinical narrative: approx 2.5 weeks after vaccination, started having frequent ectopic heart beats (symptomatic Premature atrial complexes 21% of the time on Holter monitoring). This was similar to what happened following Moderna bivalent booster one year prior, symptomactic PACs up to 29% of the time and symptoms continuing through 2+ months post-vaccination
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Supraventricular extrasystoles, Troponin normal
Clinical narrative: approx 2.5 weeks after vaccination, started having frequent ectopic heart beats (symptomatic Premature atrial complexes 21% of the time on Holter monitoring). This was similar to what happened following Moderna bivalent booster one year prior, symptomactic PACs up to 29% of the time and symptoms continuing through 2+ months post-vaccination
Age: 65.0
Sex: M
Vaccine: FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient was to receive the Pneumonia 20, I ordered the HD flu  by mistake , I verified with patient as I was giving then , realized gave wrong vaccine patient is aware He did receive the correct vaccine. and Provider is aware and stated ok to give the Pneumonia 20
Age: 1.08
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product preparation issue
Clinical narrative: Full vial of Infant Pfizer (yellow cap) was diluted with 0.7ml of sterile diluent and mixed with vial, full vial administered to the patient. No adverse reactions reported.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of consciousness
Clinical narrative: Patient passed out
Age: 1.08
Sex: M
Vaccine: RSV
Symptoms: Wrong product administered
Clinical narrative: gave the rsv vaccine instead of the pcv vaccine. the rsv vaccine was in a basket that was labeled for pcv. I was not trained on the vaccine sign out process since dept. is short staffed so I was unable to verify vaccine ordered. all documentation was done correctly in chart.the next day when trained on the vaccine sign out process thatis when I caught the medical error I had submitted.
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: I started itching on the back of my head and abdomen the same evening. The next morning, I had hives on 5-6 patches (raised, bumpy, sticker-like areas that were red and very itchy). Abdomen, elbows, back of head at the hairline, neck, back of knees. It progressed over the next 3 days (4 days of severe symptoms total), patches healed and appeared each day in new areas. Ultimately, abdomen, elbows, back of the head at the hairline, neck, chest, back of knees, bottom of feet, wrists, and eyelids were all affected.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event, Product use issue
Clinical narrative: Patient was given HPV vaccine but was also just diagnosed pregnant. No undue effects or adverse reactions noted. Reporting only due to administration guidelines.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Confusional state, Death, Jaundice, Pneumonia
Clinical narrative: INC. CONFUSION NOTED  JAUNDICE NOTED  SEND TO ER FOR EVAL & TX.  DX: PNA RESIDENT EXPIRED: 12/02/23.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Catheterisation cardiac normal, Chest X-ray, Echocardiogram, Electrocardiogram, Exercise tolerance decreased
Clinical narrative: Extreme fatigue, exercise intolerance, frequent PACs and PVCs. After symptoms persisted for 10 days, I went to the hospital and received a full cardiac workup - EKG, cardiac enzymes, echocardiogram, CXR, nuclear stress test, heart catheterization. All results were compatible with my age. Heart cath showed no coronary artery disease. There was no indication of myocarditis.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Full blood count, Metabolic function test, Myocardial necrosis marker, Scan myocardial perfusion
Clinical narrative: Extreme fatigue, exercise intolerance, frequent PACs and PVCs. After symptoms persisted for 10 days, I went to the hospital and received a full cardiac workup - EKG, cardiac enzymes, echocardiogram, CXR, nuclear stress test, heart catheterization. All results were compatible with my age. Heart cath showed no coronary artery disease. There was no indication of myocarditis.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Supraventricular extrasystoles, Ventricular extrasystoles
Clinical narrative: Extreme fatigue, exercise intolerance, frequent PACs and PVCs. After symptoms persisted for 10 days, I went to the hospital and received a full cardiac workup - EKG, cardiac enzymes, echocardiogram, CXR, nuclear stress test, heart catheterization. All results were compatible with my age. Heart cath showed no coronary artery disease. There was no indication of myocarditis.
Age: 0.58
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Abdominal distension, Dyspnoea, Hypersomnia, Infant irritability, Injection site erythema
Clinical narrative: So about 1 hour after receiving the vaccine, he started spiking a fever with irritability. He slept for 5 hours which worried me. He had shortness of breath. He started breaking out from his belly button to his feet with spots all over him. His mouth was swollen and he was pushing his tongue in and out and it seemed bigger than usual. His belly was distended/swollen. He has swelling in his leg/thigh and redness all over his thigh as well and it was swollen to double the size of his other leg with hard quarter sized knots at the injection site. The nurse said to go to the ER. I was going to take him but he finally calmed down and almost took him but ended up staying home. He woke up this morning just fine. The belly and leg swelling is better/gone, he still has the rash but located mainly in his genital area and his buttocks. His tongue is still big and kinda sitting outside his mouth like a dog does. He pushes it in and out still.
Age: 0.58
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Injection site mass, Injection site swelling, Mouth swelling, Pyrexia, Rash
Clinical narrative: So about 1 hour after receiving the vaccine, he started spiking a fever with irritability. He slept for 5 hours which worried me. He had shortness of breath. He started breaking out from his belly button to his feet with spots all over him. His mouth was swollen and he was pushing his tongue in and out and it seemed bigger than usual. His belly was distended/swollen. He has swelling in his leg/thigh and redness all over his thigh as well and it was swollen to double the size of his other leg with hard quarter sized knots at the injection site. The nurse said to go to the ER. I was going to take him but he finally calmed down and almost took him but ended up staying home. He woke up this morning just fine. The belly and leg swelling is better/gone, he still has the rash but located mainly in his genital area and his buttocks. His tongue is still big and kinda sitting outside his mouth like a dog does. He pushes it in and out still.
Age: 0.58
Sex: M
Vaccine: UNK, UNK, UNK
Symptoms: Swollen tongue
Clinical narrative: So about 1 hour after receiving the vaccine, he started spiking a fever with irritability. He slept for 5 hours which worried me. He had shortness of breath. He started breaking out from his belly button to his feet with spots all over him. His mouth was swollen and he was pushing his tongue in and out and it seemed bigger than usual. His belly was distended/swollen. He has swelling in his leg/thigh and redness all over his thigh as well and it was swollen to double the size of his other leg with hard quarter sized knots at the injection site. The nurse said to go to the ER. I was going to take him but he finally calmed down and almost took him but ended up staying home. He woke up this morning just fine. The belly and leg swelling is better/gone, he still has the rash but located mainly in his genital area and his buttocks. His tongue is still big and kinda sitting outside his mouth like a dog does. He pushes it in and out still.
Age: 20.0
Sex: F
Vaccine: FLU4, HEP, HPV9
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test positive
Clinical narrative: Patient was given HPV vaccine but had a positive pregnancy test. VAERS report submitted due to clinical indications on package insert for HPV vaccine. No Adverse events or reactions occurred for this patient, to the knowledge of the healthcare providers.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Aphasia, Computerised tomogram head, Magnetic resonance imaging head, Nervousness, Tachycardia
Clinical narrative: Complaint of feeling shaky, difficulty with thoughts and verbal expression, tachycardia. Sent patient out to hospital for evaluation. Patient had MRI and CT of brain completed. Outcome- released the next day with no restrictions.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Thinking abnormal
Clinical narrative: Complaint of feeling shaky, difficulty with thoughts and verbal expression, tachycardia. Sent patient out to hospital for evaluation. Patient had MRI and CT of brain completed. Outcome- released the next day with no restrictions.
Age: 68.0
Sex: F
Vaccine: COVID19, UNK
Symptoms: Pain
Clinical narrative: I feel achy.
Age: 52.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Blood magnesium, Chest X-ray, Differential white blood cell count, Electrocardiogram, Extrasystoles
Clinical narrative: Heart rate was 120-130 BPM and skipping beats within an hour of taking the shot.
Age: 52.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Full blood count, Metabolic function test, Troponin T
Clinical narrative: Heart rate was 120-130 BPM and skipping beats within an hour of taking the shot.
Age: 76.0
Sex: F
Vaccine: COVID19, FLUA4
Symptoms: Granuloma annulare, Laboratory test, Skin lesion
Clinical narrative: I developed Granuloma Annulare within the past eight months, possibly because I received other Covid-19 vaccinations starting in February, 2021.  I had it diagnosed by Dermatologist Dr. who did biopsy.  Report is attached.  Following Covid-19 and Flu vaccinations on Nov. 2, 2023 the Granuloma Annulare went into high gear, with there now being at least 14 separate ring shape leisions on my body.    Here are the vaccinations I've had.  I don't have all the lot numbers: 02/12/21  Moderna #03IL20A 03/12/21  Moderna DULB221A ? 10/27/21 Moderna 026D21A  04/08/22  Moderna ooiM21A (?), 07/01/22 Shingles  10/11/22 Moderna AS7164B & Flu  11/29/22  Shingles  11/2/23 Moderna & Flu.  Prescription ointments ineffective
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Medication error, Wrong product administered
Clinical narrative: Medication error. She was to receive 2nd dose of Trumenba and was given Bexsero instead.
Age: 74.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Gait disturbance, Mobility decreased, Myalgia, Pain in extremity, Somnolence
Clinical narrative: This is not easy to fill out. I don?t have all the information I threw it away but I had the flu shot and the RSV shot the next morning. I woke up every muscle in my body hurt could hardly get out of bed 15 minutes later when I could get out of bed, I was walking very slow was down for the day slept most of the day. My arm was very sore for at least seven days.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: the medical assistant who gave vaccine did not dilute prior to administration. This error was realized after patient left facility. MD notified and call placed to mom to notify.
Age: 69.0
Sex: F
Vaccine: FLU4, RSV
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: Patient reported itchiness around injection site/ side of ribs on left side. arm feels swollen and hot around area even several days after injection. Patient will take claritin and use some hydrocortisone on itchy spots. Patient will followup with doctor and we will followup with patient. As far as we know patient has not visited a doctor about it. They just reported to us.
Age: 67.0
Sex: F
Vaccine: COVID19, FLU4, RSV, COVID19, FLU4, RSV
Symptoms: Rash erythematous, Rash pruritic, Skin warm, Swelling
Clinical narrative: Red and very swollen; technicians described as a rash; patient described at time as hot, red and itchy.
Age: 67.0
Sex: F
Vaccine: COVID19, FLU4, RSV, COVID19, FLU4, RSV
Symptoms: Peripheral swelling, Rash, Rash erythematous, Skin warm
Clinical narrative: Red and very swollen; technicians described as a rash; patient described at time as hot, red and itchy.
Age: 88.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Peripheral swelling
Clinical narrative: Chest pain for 3 hours. Swollen arm.
Age: 1.75
Sex: M
Vaccine: DTAPIPVHIB, PNC20
Symptoms: Febrile convulsion
Clinical narrative: had febrile seizure