chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: COVID19
Symptoms: Induration, Pruritus, Vaccination site warmth
Clinical narrative: slight hardness over a five inch area of upper arm with constant itchiness; slight hardness over a five inch area of upper arm with constant itchiness; Warmth at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (slight hardness over a five inch area of upper arm with constant itchiness), INDURATION (slight hardness over a five inch area of upper arm with constant itchiness) and VACCINATION SITE WARMTH (Warmth at injection site) in a male patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. AV3832B) for COVID-19, SARS-CoV-2 infection, Coronavirus disease 2019, 2019-nCoV infection and 2019 novel coronavirus infection.     Previously administered products included for Product used for unknown indication: Flu shot on 16-Nov-2023. Past adverse reactions to the above products included No adverse event with Flu shot. Concurrent medical conditions included HIV disease.    On 16-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form. On 16-Nov-2023, the patient experienced PRURITUS (slight hardness over a five inch area of upper arm with constant itchiness), INDURATION (slight hardness over a five inch area of upper arm with constant itchiness) and VACCINATION SITE WARMTH (Warmth at injection site). At the time of the report, PRURITUS (slight hardness over a five inch area of upper arm with constant itchiness), INDURATION (slight hardness over a five inch area of upper arm with constant itchiness) and VACCINATION SITE WARMTH (Warmth at injection site) had not resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Patient have not had any adverse reactions to previous Moderna vaccines for Covid 19. No treatment medication reported.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 antibody test
Clinical narrative: She states that she had a positive COVID test on 26OCT2023.; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (She states that she had a positive COVID test on 26OCT2023.) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 vaccination.     No Medical History information was reported.    In 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 26-Oct-2023, the patient experienced COVID-19 (She states that she had a positive COVID test on 26OCT2023.). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 29-Oct-2023 for COVID-19 vaccination, at an unspecified dose and frequency. On 06-Nov-2023, COVID-19 (She states that she had a positive COVID test on 26OCT2023.) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Oct-2023, SARS-CoV-2 antibody test: Positive. On 03-Nov-2023, SARS-CoV-2 antibody test: Negative. On 06-Nov-2023, SARS-CoV-2 antibody test: Negative. On 09-Nov-2023, SARS-CoV-2 antibody test: Negative. On 12-Nov-2023, SARS-CoV-2 antibody test: Negative.     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.   The patient stated that she had a positive for COVID test on 26-Oct-023. She started Paxlovid on 29-Oct-2023 and finished it on 03-Nov-2023. The last shot was administered in 2022.   No concomitant medications was reported.
Sex: U
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: administration of yf-vax intramuscularly instead of subcutaneously with no reported adverse event; Initial information received on 15-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves an unknown age and gender patient to whom administration of yellow fever vaccine [YF-VAX] intramuscularly instead of subcutaneously with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an 14-Nov-2023, the patient received 0.5 ml dose of suspect yellow fever vaccine, Solution for injection (lot UJ820AB; strength and expiry date not reported) via intramuscular route in unknown administration site for Immunization instead of subcutaneously with no reported adverse event (incorrect route of product administration) (latency: on same day). Caller reported that her did not have any patient information because he just ask to gather information for the physician but the event occurred yesterday.  Action taken: not applicable.  Outcome: Unknown.   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: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Breast cancer female, Breast cancer metastatic, Breast cancer stage IV, Breast conserving surgery
Clinical narrative: On 10/29/21, received the 3rd shot for Covid-19 and was breast cancer free prior to the Moderna Booster. On 10/21/22, was diagnosed with stage 1 breast cancer. I was treated for that with a lumpectomy, and fast forward to this year on 10/13/2023, I found out the breast cancer spread and is now stage 4. Prior to receiving the Covid shots, I always had a cancer free mammogram, and I am convinced that the shot has brought the cancer to the forefront.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Epistaxis, Fatigue, Limb discomfort, Myalgia
Clinical narrative: felt heaviness in arm soon after injection, that evening felt pain in arm, fatigue, weakness, very achey sore muscles, and fever of 100, my temp is normally 97.6.  This lasted all night, and throughout the next day, with continued fever, profound fatigue, my pulse normally runs around 60-65 during the day, but it ran in the 70s the second day after injection. The second night was the same, fever, achey muscles, and very sore arm, fatigue. The next morning, Wed., I tried to go for a short walk, but felt so fatigued I came home and had a nose bleed, unusual for me. I felt such great fatigue that I went back to bed for the day. I developed a circular rash about the size of a silver dollar on my face, unusual for me. Fever was gone by the end of the second day. Today, Thursday, the 4ths day since injection, I am feeling better,  but still very fatigued, not normal for me as I am usually very busy and active.
Age: 71.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Rash
Clinical narrative: felt heaviness in arm soon after injection, that evening felt pain in arm, fatigue, weakness, very achey sore muscles, and fever of 100, my temp is normally 97.6.  This lasted all night, and throughout the next day, with continued fever, profound fatigue, my pulse normally runs around 60-65 during the day, but it ran in the 70s the second day after injection. The second night was the same, fever, achey muscles, and very sore arm, fatigue. The next morning, Wed., I tried to go for a short walk, but felt so fatigued I came home and had a nose bleed, unusual for me. I felt such great fatigue that I went back to bed for the day. I developed a circular rash about the size of a silver dollar on my face, unusual for me. Fever was gone by the end of the second day. Today, Thursday, the 4ths day since injection, I am feeling better,  but still very fatigued, not normal for me as I am usually very busy and active.
Age: 71.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Burning sensation, Headache, Herpes zoster, Myalgia, Neck pain
Clinical narrative: I developed full-blown shingles from the vaccine.  My shoulder and back are covered with a rash that is burning intensely.  Have been having headaches for a week, and the muscles of my neck are painful
Age: 71.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Rash
Clinical narrative: I developed full-blown shingles from the vaccine.  My shoulder and back are covered with a rash that is burning intensely.  Have been having headaches for a week, and the muscles of my neck are painful
Age: 71.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: I developed full-blown shingles from the vaccine.  My shoulder and back are covered with a rash that is burning intensely.  Have been having headaches for a week, and the muscles of my neck are painful
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: My arm by the injection site got very red, warm, swollen and itchy.  But the area is large, red and not getting better. I got the vaccine a week ago tomorrow.  It doesn't seem to be improving at all.  Actually looks like it's getting worse. I may have to ask or go see a dr tomorrow. Wanted to know if this was a normal reaction to the vaccine or an allergic reaction.
Age: 66.0
Sex: F
Vaccine: COVID19-2
Symptoms: Tinnitus
Clinical narrative: Tinnitus - continuous high pitched noise
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Feeling drunk, Headache, Nausea
Clinical narrative: Fever with chills at 12 hours after shot was given, severe nausea, dizziness, headache. Acting drunk from fever. Treated with ibuprofen and zofran (zofran is prescription as needed). Fever broke four hours later during the middle of the night, and all other symptoms dissipated while sleeping.
Age: 27.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: Fever with chills at 12 hours after shot was given, severe nausea, dizziness, headache. Acting drunk from fever. Treated with ibuprofen and zofran (zofran is prescription as needed). Fever broke four hours later during the middle of the night, and all other symptoms dissipated while sleeping.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature decreased, Body temperature fluctuation, Body temperature increased, Chills, Disorientation
Clinical narrative: Early Monday afternoon, I had chills and had to bundle up in blankets. Temperature was 95.7 taken twice with two digital thermometers. I felt dizzy and at ties disoriented. I stayed bundled in there blankets for the day. Later that evening my temperature shot up to 103.6. After a few hours my temperature dropped to 96.7. The alternating high and low temperature continued until Wednesday November 22. My temperature now (November 24) is 97.8. I am listless, my eyes feel swollen and there is pressure on my sinuses. I feel run own.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Eye swelling, Fatigue, Listless, Paranasal sinus discomfort
Clinical narrative: Early Monday afternoon, I had chills and had to bundle up in blankets. Temperature was 95.7 taken twice with two digital thermometers. I felt dizzy and at ties disoriented. I stayed bundled in there blankets for the day. Later that evening my temperature shot up to 103.6. After a few hours my temperature dropped to 96.7. The alternating high and low temperature continued until Wednesday November 22. My temperature now (November 24) is 97.8. I am listless, my eyes feel swollen and there is pressure on my sinuses. I feel run own.
Age: 57.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Rash
Clinical narrative: Rash developed from underneath the breast to hip on day 2 post vaccination.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dysphonia, Eye discharge, Fatigue, Injection site pain
Clinical narrative: Possible Oculo-Repsiratory Syndrom as described in studies in early 2000s.  Vaccine at 7pm, went to sleep a bit after 8pm. Woke up at midnight - eye discharge, chest a bit tight, throat a bit hoarse.  Took 200mg ibuprofen and hot shower and went back to bed. Woke up again at 7am - swelling of eyelids and green eye discharge OU, voice hoarse (no throat pain), mild nasal congestion with no discharge, slight wheeze on deep breath, slight urge to for soft cough a couple of times, lethargic / tired, mild pain at injection site.  Did not take temperature. COVID-19 test (at home Elisa) negative.  Feeling a bit better now at 11am at time of reporting.  Patient (I) wear KN-95 most of the time so unlikely other viral or bacterial infection.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Lethargy, Nasal congestion, SARS-CoV-2 test negative, Swelling of eyelid, Wheezing
Clinical narrative: Possible Oculo-Repsiratory Syndrom as described in studies in early 2000s.  Vaccine at 7pm, went to sleep a bit after 8pm. Woke up at midnight - eye discharge, chest a bit tight, throat a bit hoarse.  Took 200mg ibuprofen and hot shower and went back to bed. Woke up again at 7am - swelling of eyelids and green eye discharge OU, voice hoarse (no throat pain), mild nasal congestion with no discharge, slight wheeze on deep breath, slight urge to for soft cough a couple of times, lethargic / tired, mild pain at injection site.  Did not take temperature. COVID-19 test (at home Elisa) negative.  Feeling a bit better now at 11am at time of reporting.  Patient (I) wear KN-95 most of the time so unlikely other viral or bacterial infection.
Age: 2.0
Sex: F
Vaccine: UNK
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Patient received meningococcal B (BEXSERO) despite being < 10 years. The patient appropriately received meningococcal conjugate (MENVEO) for emergent initiation of eculizumab therapy. The BEXSERO was inadvertently ordered and administered. No significant ADRs have been reported thus far. This is being filed since inappropriately given. Patient was already intubated in a PICU prior to administering.
Age: 52.0
Sex: F
Vaccine: TD
Symptoms: Erythema, Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: After the normal knot and swelling at the injection site 24 hours later, underneath both my left and right arm became red and hot to the touch.  The redness traveled down to my forearms and parts of my back.
Age: 94.0
Sex: F
Vaccine: COVID19-2
Symptoms: Computerised tomogram, Disorganised speech, Electrocardiogram, Electroencephalogram, Gait disturbance
Clinical narrative: Stroke like symptoms.  Talking gibberish, no known words.  Staggering, then unable to walk.
Age: 94.0
Sex: F
Vaccine: COVID19-2
Symptoms: Gait inability, Laboratory test, Neurological symptom
Clinical narrative: Stroke like symptoms.  Talking gibberish, no known words.  Staggering, then unable to walk.
Age: 63.0
Sex: M
Vaccine: COVID19, RSV, VARZOS
Symptoms: Chills
Clinical narrative: Chills.  At first controlled with an additional layer of clothing then later, while in bed, by curling up and covering with an additional layer of blanket.  That didn't actually fix the problem, but made it bearable.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood test abnormal, Chills, Fatigue, Immunisation reaction, Injection site erythema
Clinical narrative: The injection instantly created aches in my arm.  I started developing chills and body aches about 5 hours after the vaccination.  Around 8 hours later, I also got severe vertigo to the point that I could not open my eyes and was throwing up, which was reason for me to visit the ER. After 4 hours in the ER with Zofran and Meclizine I was discharged. Severe aches persisted for 5 days and I was unable to leave the bed because of exhaustion and pain. After a week the aches subsided. The infection site showed a red patch the size of a hand that remained for 2 weeks. After it went away the skin in that area began to flake off and peel. Even after the peeling, the area is still visibly discolored with a reddish tone.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site exfoliation, Mobility decreased, Pain, Pain in extremity, Vertigo
Clinical narrative: The injection instantly created aches in my arm.  I started developing chills and body aches about 5 hours after the vaccination.  Around 8 hours later, I also got severe vertigo to the point that I could not open my eyes and was throwing up, which was reason for me to visit the ER. After 4 hours in the ER with Zofran and Meclizine I was discharged. Severe aches persisted for 5 days and I was unable to leave the bed because of exhaustion and pain. After a week the aches subsided. The infection site showed a red patch the size of a hand that remained for 2 weeks. After it went away the skin in that area began to flake off and peel. Even after the peeling, the area is still visibly discolored with a reddish tone.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: The injection instantly created aches in my arm.  I started developing chills and body aches about 5 hours after the vaccination.  Around 8 hours later, I also got severe vertigo to the point that I could not open my eyes and was throwing up, which was reason for me to visit the ER. After 4 hours in the ER with Zofran and Meclizine I was discharged. Severe aches persisted for 5 days and I was unable to leave the bed because of exhaustion and pain. After a week the aches subsided. The infection site showed a red patch the size of a hand that remained for 2 weeks. After it went away the skin in that area began to flake off and peel. Even after the peeling, the area is still visibly discolored with a reddish tone.
Age: 72.0
Sex: F
Vaccine: RSV
Symptoms: Diarrhoea, Headache, Muscular weakness, Pyrexia, Vomiting
Clinical narrative: Diarrhea, vomiting, feverish, muscle weakness, headache
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Mass, Musculoskeletal stiffness, Pain, Tenderness
Clinical narrative: The lumps appeared on my back of head and front near eye brows. Their sides are about nickel. Pain without touching for about 4 days, then pain only when touched. No itching nor red.  The symthom is persist as of today 11/23 /2023. The other is neck stiffness. BTW, i did not save the vaccine info.
Age: 73.0
Sex: M
Vaccine: PNC20
Symptoms: Injection site pain, Limb discomfort, Pain
Clinical narrative: The injection site remains painful.  It throbs later in the day and now, raising my right arm causes significant discomfort.  If I spend longer than 20 minutes at my computer, the injection site begins to hurt and increases in pain as time passes.
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Erythema, Fatigue, Feeling cold, Nausea, Swelling
Clinical narrative: Wide, raised, red welt, patient fatigued, nauseous,chilled for five days, red welt continued until todate?11-23-2024.
Age: 71.0
Sex: F
Vaccine: PNC20
Symptoms: Urticaria
Clinical narrative: Wide, raised, red welt, patient fatigued, nauseous,chilled for five days, red welt continued until todate?11-23-2024.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea, Lethargy, Malaise, Productive cough
Clinical narrative: severe malaise and lethargy for two days; mild shortness of breath and cough productive of clear mucous for 5 weeks with slow improvement; This could be a conincidental illness with symptoms starting after the vaccine but I had no illnesses for many months prior to this. Though symptoms haven't resolved completely, they seem to be improving and I'm reporting in case there are others, especially if they are on Remicade.  There was a much milder, but similar response following my fourth COVID vaccine which was also Moderna and I had no issues at all with the prior 3 Pfizer COVID vaccines.
Age: 36.0
Sex: F
Vaccine: COVID19-2, FLUX
Symptoms: Anxiety, Headache, Panic attack, Paranoia, Thinking abnormal
Clinical narrative: Paranoia, anxiety, panic attack, headache, jumbled thoughts
Age: 15.0
Sex: F
Vaccine: HEP
Symptoms: Extra dose administered
Clinical narrative: Extra dose of Hepatits B administered on 11/23/2023. Child was complete with 3 doses of Hepatitis B series Historical administered dates of Hepatitis B are:  01/05/2009  04/27/2009  06/26/2009???
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: My mother had a stroke within 48 hours of her Covid vaccination. She was found more than 24 hours after the event and the hospital did not determine a cause. She was hospitalized for 4 days then transferred to rehab for 2.5 weeks and is now in ongoing out-patient care.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Asthma, Blood test normal, Contraindication to vaccination, Dizziness, Gait inability
Clinical narrative: I received the RSV vaccine on Sunday, Nov. 19 at 3 pm. Unsure if it was arexvy or abrysvo. I began to feel dizzy Sunday night. The dizziness progressed to severe, debilitating vertigo until Monday 11/20 I had to go to ER for severe vertigo, muscle weakness (unable to walk or sit), nausea with vomiting multiple times. Brain scans indicated no brain or arterial pathology. Following discharge from ER 6 hours later, severe asthma began that evening and progressed, so that I required additional anti-asthma medication (prednisone and increased rescue inhaler).   I have severe food intolerances to wheat and corn - they result in acute GI distress lasting days when ingested orally.  Mannitol is a key ingredient in the infusion for the Abrysvo vaccine and is made from either wheat or corn, and ingredient lists state that proteins associated with manufacturing products may be in the vaccine. It is possible that the mannitol was responsible for the toxic adverse reaction, If so, people with gluten, wheat, or corn intolerances should be advised to be cautious about this vaccine.  I have never had adverse reactions to COVID or flu vaccines, but those vaccines do not have ingredients derived from wheat or corn in them.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Magnetic resonance imaging head normal, Magnetic resonance imaging neck, Magnetic resonance imaging normal, Muscular weakness, Nausea
Clinical narrative: I received the RSV vaccine on Sunday, Nov. 19 at 3 pm. Unsure if it was arexvy or abrysvo. I began to feel dizzy Sunday night. The dizziness progressed to severe, debilitating vertigo until Monday 11/20 I had to go to ER for severe vertigo, muscle weakness (unable to walk or sit), nausea with vomiting multiple times. Brain scans indicated no brain or arterial pathology. Following discharge from ER 6 hours later, severe asthma began that evening and progressed, so that I required additional anti-asthma medication (prednisone and increased rescue inhaler).   I have severe food intolerances to wheat and corn - they result in acute GI distress lasting days when ingested orally.  Mannitol is a key ingredient in the infusion for the Abrysvo vaccine and is made from either wheat or corn, and ingredient lists state that proteins associated with manufacturing products may be in the vaccine. It is possible that the mannitol was responsible for the toxic adverse reaction, If so, people with gluten, wheat, or corn intolerances should be advised to be cautious about this vaccine.  I have never had adverse reactions to COVID or flu vaccines, but those vaccines do not have ingredients derived from wheat or corn in them.
Age: 70.0
Sex: F
Vaccine: RSV
Symptoms: Vertigo, Vomiting
Clinical narrative: I received the RSV vaccine on Sunday, Nov. 19 at 3 pm. Unsure if it was arexvy or abrysvo. I began to feel dizzy Sunday night. The dizziness progressed to severe, debilitating vertigo until Monday 11/20 I had to go to ER for severe vertigo, muscle weakness (unable to walk or sit), nausea with vomiting multiple times. Brain scans indicated no brain or arterial pathology. Following discharge from ER 6 hours later, severe asthma began that evening and progressed, so that I required additional anti-asthma medication (prednisone and increased rescue inhaler).   I have severe food intolerances to wheat and corn - they result in acute GI distress lasting days when ingested orally.  Mannitol is a key ingredient in the infusion for the Abrysvo vaccine and is made from either wheat or corn, and ingredient lists state that proteins associated with manufacturing products may be in the vaccine. It is possible that the mannitol was responsible for the toxic adverse reaction, If so, people with gluten, wheat, or corn intolerances should be advised to be cautious about this vaccine.  I have never had adverse reactions to COVID or flu vaccines, but those vaccines do not have ingredients derived from wheat or corn in them.
Age: 30.0
Sex: M
Vaccine: FLUA4, FLU4
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Numbness in his R foot that traveled up to his knee and R hand; Tingly in his R foot that traveled up to his knee and R hand; This spontaneous case was retrieved on 13-Nov-2023 from Vaccine Adverse Event Reporting System (VAERS) (reference number: 2696247-1), reported by other healthcare professional, and concerned a 30-year-old, male patient.   The patient's medical history and concomitant medications were not reported. The patient had no known drug allergies.  It was reported that on 15-Oct-2023 at 10:00 am, the patient was vaccinated with Fluad Quadrivalent (influenza vaccine inact sag 4v; dose: reported as 1, route of administration: intramuscular (IM), anatomical location: right arm (RA), and indication: not reported). The batch number reported was AU1075A. The reported batch number was identified by Seqirus to be linked to the suspect product Afluria Quadrivalent (Influenza vaccine inact split 4v) instead of the reported suspect product Fluad Quadrivalent.  Based on the reported batch number, the suspect product was changed to Afluria Quadrivalent.   On the same date, minutes after vaccination with Afluria Quadrivalent, the patient experienced mild tingling and numbness in his right foot. As reported, the patient ignored the symptoms until hours later when they didn't go away and travelled up to the knee and right hand.   On the same date, the patient had a medical examination by provider, and showed no signs of anaphylactic shock. Neurological assessment: within defined limits (WDL) with exception of numbness and tingling in reported areas. The patient's vital signs were blood pressure (BP) 150/89, heart rate (HR) 102, temperature (T) 98.8 oral, oxygen saturation (O2) 96%, and respiratory rate (RR) 18. No units were provided.  At the time of the initial reporting, the patient had not recovered from the events.   The reporter did not provide a causality assessment.   The case was assessed as non-serious.  Company comment: On the same date, minutes after vaccination with Afluria Quadrivalent, the patient experienced mild tingling and numbness in his right foot. As reported, the patient ignored the symptoms until hours later when they didn't go away and travelled up to the knee and right hand. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is assessed as possibly related, based on chronological plausibility.; Sender's Comments: On the same date, minutes after vaccination with Afluria Quadrivalent, the patient experienced mild tingling and numbness in his right foot. As reported, the patient ignored the symptoms until hours later when they didn't go away and travelled up to the knee and right hand. The patient's medical history and concomitant medications were not reported. Causal role of the suspect vaccine is assessed as possibly related, based on chronological plausibility.
Sex: U
Vaccine: COVID19-2, COVID19
Symptoms: Erythema, Lip swelling
Clinical narrative: inside of both lips began to swell and have remained swollen to date; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (Dose 3, manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (Dose 4, manufacturer unknown), for Covid-19 immunisation. The following information was reported: LIP SWELLING (non-serious) with onset 22Sep2023, outcome "not recovered", described as "inside of both lips began to swell and have remained swollen to date". Therapeutic measures were taken as a result of lip swelling.  Additional information: The patient received 5th Covid shot on 18Sep2023, on 22Sep2023 the inside of both lips began to swell and have remained swollen to date. Patient doctor hasdtried Duke's Magic mouthwash, valacylovir 1 gm, and methylprednisone 4 mg (21 pack). To date, nothing has helped with the swelling. Looking for any advise as to how patient can get rid of the swelling.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.
Sex: U
Vaccine: COVID19-2, COVID19
Symptoms: Lip swelling
Clinical narrative: inside of both lips began to swell and have remained swollen to date; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A patient (no qualifiers provided) received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 18Sep2023 as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Dose 1, manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (Dose 2, manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (Dose 3, manufacturer unknown), for Covid-19 immunisation; Covid-19 vaccine (Dose 4, manufacturer unknown), for Covid-19 immunisation. The following information was reported: LIP SWELLING (non-serious) with onset 22Sep2023, outcome "not recovered", described as "inside of both lips began to swell and have remained swollen to date". Therapeutic measures were taken as a result of lip swelling.  Additional information: The patient received 5th Covid shot on 18Sep2023, on 22Sep2023 the inside of both lips began to swell and have remained swollen to date. Patient doctor hasdtried Duke's Magic mouthwash, valacylovir 1 gm, and methylprednisone 4 mg (21 pack). To date, nothing has helped with the swelling. Looking for any advise as to how patient can get rid of the swelling.  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: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: each time, only had sore spot to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (First dose, Lot. EN6200), administration date: 26Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch"; bnt162b2 (Second dose, Lot. EN6206), administration date: 19Mar2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch"; bnt162b2 (Third dose, Lot. FH8027), administration date: 14Nov2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch"; bnt162b2 (Fourth dose, Lot. FK9894), administration date: 19Apr2022, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch". The following information was reported: PAIN (non-serious), outcome "unknown", described as "each time, only had sore spot to touch". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Each time, only had sore spot to touch and negative COVID-19 test (PCR) after the vaccinations.
Age: 71.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain, SARS-CoV-2 test
Clinical narrative: each time, only had sore spot to touch; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient received bnt162b2, bnt162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 27Sep2022 as dose 5 (booster), single (Lot number: GH9694) at the age of 71 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: bnt162b2 (First dose, Lot. EN6200), administration date: 26Feb2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch"; bnt162b2 (Second dose, Lot. EN6206), administration date: 19Mar2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch"; bnt162b2 (Third dose, Lot. FH8027), administration date: 14Nov2021, when the patient was 70-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch"; bnt162b2 (Fourth dose, Lot. FK9894), administration date: 19Apr2022, when the patient was 71-year-old, for COVID-19 immunization, reaction(s): "each time, only had sore spot to touch". The following information was reported: PAIN (non-serious), outcome "unknown", described as "each time, only had sore spot to touch". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: Each time, only had sore spot to touch and negative COVID-19 test (PCR) after the vaccinations.
Age: 36.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Expired product administered
Clinical narrative: No additional AEs; Caller reported expired dose of GARDASIL 9 was administered.  Caller asked what side effects would be expected.  No other information provided.  No additional AEs or PQC reported.; Information has been received from a pharmacist, referring to a 36 years-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 17-NOV-2023, the patient was vaccinated with an expire dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #U019413, expiration date: 01-NOV-2023, administered intramuscularly for prophylaxis (strength was not provided). No additional adverse events were reported.
Age: 36.0
Sex: U
Vaccine: HPV9, HPV9
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AEs; Caller reported expired dose of GARDASIL 9 was administered.  Caller asked what side effects would be expected.  No other information provided.  No additional AEs or PQC reported.; Information has been received from a pharmacist, referring to a 36 years-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported.   On 17-NOV-2023, the patient was vaccinated with an expire dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, 0.5 milliliter, lot #U019413, expiration date: 01-NOV-2023, administered intramuscularly for prophylaxis (strength was not provided). No additional adverse events were reported.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Blood pressure measurement, Transient ischaemic attack
Clinical narrative: Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "thyroid condition" (ongoing); "high blood pressure" (ongoing); "Overweight" (unspecified if ongoing). The patient's family history included: "mini stroke" (unspecified if ongoing), notes: grandmother had stroke, that was years ago. The patient took concomitant medications. Vaccination history included: Moderna (DOSE 1, SINGLE), for COVID-19 immunisation; Moderna (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive, notes: tested positive for Covid, had Covid vaccine. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Expiry Date of Covid vaccine: Unknown. 76 year old diabetes patient, took Paxlovid 31Oct. That time, tested negative for Covid, husband had Covid. Healthcare provider stated to caller, she should get the medication, as she was in contact with husband. Caller was also taking Apixaban. Last Saturday, caller went to urgent care. Caller tested positive with Covid this morning, was prescribed Paxlovid again. She started previous round of Paxlovid, 30Oct2023 or 31Oct2023. Concomitant Products/Medical Conditions: Got thyroid condition, had diabetes, high blood pressure, was on all kinds of medicine. Had probably been a couple of years at least, had mini stroke, then they put her on it.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300188223 same patient/product, different event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Covid; Covid; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 76-year-old female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (ongoing); "thyroid condition" (ongoing); "high blood pressure" (ongoing); "Overweight" (unspecified if ongoing). The patient's family history included: "mini stroke" (unspecified if ongoing), notes: grandmother had stroke, that was years ago. The patient took concomitant medications. Vaccination history included: Moderna (DOSE 1, SINGLE), for COVID-19 immunisation; Moderna (DOSE 2, SINGLE), for COVID-19 immunisation. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Nov2023, outcome "unknown" and all described as "Covid". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (Nov2023) Positive, notes: tested positive for Covid, had Covid vaccine. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Expiry Date of Covid vaccine: Unknown. 76 year old diabetes patient, took Paxlovid 31Oct. That time, tested negative for Covid, husband had Covid. Healthcare provider stated to caller, she should get the medication, as she was in contact with husband. Caller was also taking Apixaban. Last Saturday, caller went to urgent care. Caller tested positive with Covid this morning, was prescribed Paxlovid again. She started previous round of Paxlovid, 30Oct2023 or 31Oct2023. Concomitant Products/Medical Conditions: Got thyroid condition, had diabetes, high blood pressure, was on all kinds of medicine. Had probably been a couple of years at least, had mini stroke, then they put her on it.  The information on the batch/lot number for bnt162b2 omi xbb.1.5 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-PV202300188223 same patient/product, different event;
Age: 46.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Joint range of motion decreased, Pain
Clinical narrative: Patient called pharmacy on 11/22/23 to inform us that she sustained a shoulder injury after receiving vaccines on 11/2/23. She received both Fluzone and Comirnaty on her left deltoid and described that after receiving Fluzone vaccine, she immediately experienced pain and locked shoulder. Patient reported having a limited range of motion immediately after and still currently having some limitation in motion on her left shoulder although it has improved from the date of vaccination. I do not have information on what treatment she received or the outcomes related to this event.
Age: 46.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Joint range of motion decreased, Limb injury, Pain
Clinical narrative: Patient called pharmacy on 11/22/23 to inform us that she sustained a shoulder injury after receiving vaccines on 11/2/23. She received both Fluzone and Comirnaty on her left deltoid and described that after receiving Fluzone vaccine, she immediately experienced pain and locked shoulder. Patient reported having a limited range of motion immediately after and still currently having some limitation in motion on her left shoulder although it has improved from the date of vaccination. I do not have information on what treatment she received or the outcomes related to this event.
Age: 46.0
Sex: F
Vaccine: COVID19, FLU4, COVID19, FLU4
Symptoms: Periarthritis
Clinical narrative: Patient called pharmacy on 11/22/23 to inform us that she sustained a shoulder injury after receiving vaccines on 11/2/23. She received both Fluzone and Comirnaty on her left deltoid and described that after receiving Fluzone vaccine, she immediately experienced pain and locked shoulder. Patient reported having a limited range of motion immediately after and still currently having some limitation in motion on her left shoulder although it has improved from the date of vaccination. I do not have information on what treatment she received or the outcomes related to this event.
Age: 68.0
Sex: F
Vaccine: RSV
Symptoms: Arthralgia, Dizziness, Headache, Nausea, Pyrexia
Clinical narrative: Headache, dizziness, nausea, joint pain and fever of 102 degrees
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Asthenia, Body temperature decreased, Chest pain, Chills, Decreased appetite
Clinical narrative: Sore arm began around 5pm on date of injection. 11:50 pm after a hot shower I began to experience shivering. I had an ice pack on the injection site for swelling and pain. After removing the ice pack I had convulsive shivering and low body temp for two and a half hours. Also noticed while laying on right side of body I had very sharp pain in my chest, right side, central location. Worse when inhaling.  Layered up on clothing, blankets, attempted to fall asleep. Woke up in the morning sweating with a fever of 100.6 and extreme body pain and a migraine. Had no energy, no appetite, and a lot of pain.  Arm pain was slightly better than it had been at night but still significant.  Took 800mg ibuprofen to alleviate the symptoms. Slept until 1:30pm. Went to work in tears, left work early. Will not be attending work tomorrow 11/24 due to symptoms. Migraine still active, body pain 7/10, arm pain 5/10. Fever seems to have ended
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Hyperhidrosis, Impaired work ability, Injection site pain, Injection site swelling, Migraine
Clinical narrative: Sore arm began around 5pm on date of injection. 11:50 pm after a hot shower I began to experience shivering. I had an ice pack on the injection site for swelling and pain. After removing the ice pack I had convulsive shivering and low body temp for two and a half hours. Also noticed while laying on right side of body I had very sharp pain in my chest, right side, central location. Worse when inhaling.  Layered up on clothing, blankets, attempted to fall asleep. Woke up in the morning sweating with a fever of 100.6 and extreme body pain and a migraine. Had no energy, no appetite, and a lot of pain.  Arm pain was slightly better than it had been at night but still significant.  Took 800mg ibuprofen to alleviate the symptoms. Slept until 1:30pm. Went to work in tears, left work early. Will not be attending work tomorrow 11/24 due to symptoms. Migraine still active, body pain 7/10, arm pain 5/10. Fever seems to have ended
Age: 25.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain, Pain in extremity, Painful respiration, Pyrexia, Tearfulness
Clinical narrative: Sore arm began around 5pm on date of injection. 11:50 pm after a hot shower I began to experience shivering. I had an ice pack on the injection site for swelling and pain. After removing the ice pack I had convulsive shivering and low body temp for two and a half hours. Also noticed while laying on right side of body I had very sharp pain in my chest, right side, central location. Worse when inhaling.  Layered up on clothing, blankets, attempted to fall asleep. Woke up in the morning sweating with a fever of 100.6 and extreme body pain and a migraine. Had no energy, no appetite, and a lot of pain.  Arm pain was slightly better than it had been at night but still significant.  Took 800mg ibuprofen to alleviate the symptoms. Slept until 1:30pm. Went to work in tears, left work early. Will not be attending work tomorrow 11/24 due to symptoms. Migraine still active, body pain 7/10, arm pain 5/10. Fever seems to have ended
Age: 0.33
Sex: F
Vaccine: PPV
Symptoms: Decreased appetite, Product administered to patient of inappropriate age
Clinical narrative: inadvertent administration of PNEUMOVAX 23 to a 4-month-old patient; decreased appetite; This spontaneous report was received from a medical assistant and refers to a 4-month-old female patient. The patient's concurrent conditions, concomitant therapies, historical drugs and historical conditions were not reported.  On 20-OCT-2023, the patient was vaccinated  with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered for prophylaxis inadvertently (strength, dose, lot #, expiry date, anatomical site of administration and route of administration were not provided) (product administered to patient of inappropriate age).  On an unknown date in October 2023, the patient experienced decreased appetite. No treatment was given. At the time of reporting, the outcome of decreased appetite was not known. The causal relationship between decreased appetite and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: patient received his first GARDASIL 9 dose on 9/28/2021 and was trying to obtain the rest of the doses now, as he was not aware initially that he had to get 2 more doses.; No additional AE; This spontaneous report was received from a pharmacist referring to a 33 years old male patient. The patient's concomitant medication, pertinent medical history and drug reactions/ allergies were not reported.  On 28-SEP-2021, the patient was vaccinated with his first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (0.5 milliliter; strength, route, lot# and expiration date were not reported) for prophylaxis.       He was trying to obtain the rest of the doses now, as he was not aware initially that he had to get 2 more doses (inappropriate schedule of product administration). No additional adverse event (AE) was reported (no adverse event).