chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site swelling, Injection site vesicles, Pruritus, Urticaria
Clinical narrative: itching all over that area/itching around her waistline/It looks all red and pimply; the swelling continued around the site; injection site had big blisters on it and it was quite painful was quite painful.; Hives; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE VESICLES (injection site had big blisters on it and it was quite painful was quite painful.), PRURITUS (itching all over that area/itching around her waistline/It looks all red and pimply), URTICARIA (Hives) and INJECTION SITE SWELLING (the swelling continued around the site) in an 89-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8058081) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Flu vaccine on 30-Oct-2023. Past adverse reactions to the above products included No adverse event with Flu vaccine.    On 03-Nov-2023, the patient received fifth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In 2023, the patient experienced URTICARIA (Hives). On 04-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced INJECTION SITE VESICLES (injection site had big blisters on it and it was quite painful was quite painful.). On 05-Nov-2023, the patient experienced INJECTION SITE SWELLING (the swelling continued around the site). On an unknown date, the patient experienced PRURITUS (itching all over that area/itching around her waistline/It looks all red and pimply). At the time of the report, INJECTION SITE VESICLES (injection site had big blisters on it and it was quite painful was quite painful.), PRURITUS (itching all over that area/itching around her waistline/It looks all red and pimply), URTICARIA (Hives) and INJECTION SITE SWELLING (the swelling continued around the site) had not resolved.            No concomitant medication was reported.  Patient went to emergency room who thought she had shingles. Patient was given an antibiotic, antiviral, and steroid, started taking before reporting.   This case was linked to MOD-2023-748616 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash 9 days after arms, legs and trunk; This spontaneous case was reported by an other health care professional and describes the occurrence of RASH (Rash 9 days after arms, legs and trunk) in a 63-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) .5 milliliter. On 01-Nov-2023, the patient experienced RASH (Rash 9 days after arms, legs and trunk). At the time of the report, RASH (Rash 9 days after arms, legs and trunk) 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.   Concomitant medications were not reported.  It is unknown if the patient experienced any additional symptoms/events. No treatment information was provided by the reporter.
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Injection site reaction, Urticaria, Wheezing
Clinical narrative: hives/welts from her feet to her scalp; wheezing; shortness of breath; Where she received the injection looked like bubble wrap; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/welts from her feet to her scalp), WHEEZING (wheezing), DYSPNOEA (shortness of breath) and INJECTION SITE REACTION (Where she received the injection looked like bubble wrap) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer vaccine. Past adverse reactions to the above products included No adverse event with Pfizer vaccine.    In October 2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (hives/welts from her feet to her scalp), WHEEZING (wheezing), DYSPNOEA (shortness of breath) and INJECTION SITE REACTION (Where she received the injection looked like bubble wrap). At the time of the report, URTICARIA (hives/welts from her feet to her scalp), WHEEZING (wheezing) and DYSPNOEA (shortness of breath) had not resolved and INJECTION SITE REACTION (Where she received the injection looked like bubble wrap) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Patient took steroid and when the steroids stopped her welts came back. They were not as severe as when they first started, but she continued to have them on her legs, back, shoulders, face, and chin.   Reporter did not allow further contact
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Product administration error
Clinical narrative: he was giving some misgivings; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT ADMINISTRATION ERROR (he was giving some misgivings) in a 74-year-old patient of an unknown gender who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTRATION ERROR (he was giving some misgivings). At the time of the report, PRODUCT ADMINISTRATION ERROR (he was giving some misgivings) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported. The dosage text was reported as unknown. The patient had a total of 6 Moderna, 2 original, 2 bivalent and 2 mRNA. Patient reported that their doctor when they saw them in October they were due now and he was giving some misgivings.  It was reported that the mRNA temporary interferes with interferons and leaving an individual in a vulnerable situation with any other infections. No treatment medication was reported.
Age: 70.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chronic inflammatory demyelinating polyradiculoneuropathy
Clinical narrative: CIDP; This spontaneous case was reported by a patient and describes the occurrence of CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (CIDP) in a 70-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7146B) for COVID-19 prophylaxis.     Patient had no listed conditions besides CIDP.     On 24-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. In March 2023, the patient experienced CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (CIDP) (seriousness criterion medically significant). At the time of the report, CHRONIC INFLAMMATORY DEMYELINATING POLYRADICULONEUROPATHY (CIDP) had not resolved.            It was reported that patient did not receives any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Patient receives 1st dose of moderna vaccine on 13-Jan-2021 (lot number:- 013L20A), 2nd dose of moderna vaccine on 10-Feb-2021 (Lot number:- 006D21A), 3rd dose of moderna vaccine on 22-Oct-2021 (lot number:- WOG4545) and 4th dose on 08-Apr-2022 (Lot number:- 065K21A)  It was reported that patient was diagnosed with Chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) on Mar-2023 and on 28-Sep-2023 she was treated with IVIG treatment. Company comment: This spontaneous case concerns a 70-year-old female patient, with no medical history of reported, who experienced the unexpected, serious(medically significant) AESI of Chronic inflammatory demyelinating polyradiculoneuropathy which occurred app. 4,5 months after Spikevax Bivalent .222 (Original/Omicron BA.4/5) dose administration, which was the 5th dose of COVID-19 vaccination schedule. Primary vaccination series (1st and 2nd dose) with 2 booster doses were performed with Moderna Covid-19 vaccine. Event treatment included intravenous immunoglobulin and was reported to start app. 6 months after event onset. No further clinical information or details on event course, medical history, etiologic and diagnostic work up were provided for medical review. Event outcome was not resolved at the time of the report. The benefit-risk relationship of Spikevax Bivalent .222 (Original/Omicron BA.4/5) vaccine is not affected by this report.
Age: 42.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Lymph node pain, Swelling, Vaccination site mass, Vaccination site swelling
Clinical narrative: Swelling in other armpit; substantial pain in lymph node under arm on same side; Small lump below injection site; Small lump below injection site + severe swelling; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Swelling in other armpit) in a 42-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) (batch no. 8057459) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    No Medical History information was reported.   On 06-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 07-Nov-2023, the patient experienced SWELLING (Swelling in other armpit) (seriousness criterion life threatening), LYMPH NODE PAIN (substantial pain in lymph node under arm on same side), VACCINATION SITE MASS (Small lump below injection site) and VACCINATION SITE SWELLING (Small lump below injection site + severe swelling). At the time of the report, SWELLING (Swelling in other armpit) and LYMPH NODE PAIN (substantial pain in lymph node under arm on same side) had not resolved and VACCINATION SITE MASS (Small lump below injection site) and VACCINATION SITE SWELLING (Small lump below injection site + severe swelling) outcome was unknown.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   Concomitant medication was not reported. The patient had covid arm after vaccination for 2nd dose.   The patient received flu shot at same time in same arm during SPIKEVAX 2023-2024 vaccination. The patient developed small lump below injection site, severe swelling and substantial pain in lymph node under arm on same side. Swelling in other armpit was not as noticeable but present.  Treatment medication was not reported.   This case was linked to MOD-2021-138597 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Rash erythematous, Rash pruritic, Swelling
Clinical narrative: They had a bad rash, but it does not hurt. It is swollen, itchy and red; They had a bad rash, but it does not hurt. It is swollen, itchy and red; They had a bad rash, but it does not hurt. It is swollen, itchy and red; This spontaneous case was reported by a patient and describes the occurrence of SWELLING (They had a bad rash, but it does not hurt. It is swollen, itchy and red), RASH PRURITIC (They had a bad rash, but it does not hurt. It is swollen, itchy and red) and RASH ERYTHEMATOUS (They had a bad rash, but it does not hurt. It is swollen, itchy and red) in a 58-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     The patient's past medical history included COVID-19 on 25-Aug-2020. Previously administered products included for Product used for unknown indication: Flu shot (27 or 28-SEP-2023) in September 2023. Past adverse reactions to the above products included No adverse event with Flu shot.    On 04-Nov-2023, the patient received sixth dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING (They had a bad rash, but it does not hurt. It is swollen, itchy and red), RASH PRURITIC (They had a bad rash, but it does not hurt. It is swollen, itchy and red) and RASH ERYTHEMATOUS (They had a bad rash, but it does not hurt. It is swollen, itchy and red). At the time of the report, SWELLING (They had a bad rash, but it does not hurt. It is swollen, itchy and red), RASH PRURITIC (They had a bad rash, but it does not hurt. It is swollen, itchy and red) and RASH ERYTHEMATOUS (They had a bad rash, but it does not hurt. It is swollen, itchy and red) had not resolved.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  The patient received first dose on 29-Jan-2021 and the lot number 0303L20A. Second dose received on 26-Feb-2021 and the lot number 0303L20A. Third dose received on 22-Oct-2021 (Booster) and the lot number 084G21A. Fourth dose received on 09-Apr-2022 and the lot number Unknown. Fifth dose received on 03-Oct-2022 and the lot number 027E22A. No treatment information was provided by the reporter.
Age: 28.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Chills, Fatigue, Feeling hot, Headache, Pain
Clinical narrative: Shaking uncontrollably; I became very hot and removed all the warm clothes; Aches; Sore arm; Chills; had a slight headache for a few hours; Had a little fatigue, tired earlier than normal; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Shaking uncontrollably), FEELING HOT (I became very hot and removed all the warm clothes), PAIN (Aches), PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) in a 28-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    The patient's past medical history included COVID-19 on 14-Jul-2022. Concomitant products included IBUPROFEN for an unknown indication.   On 07-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 07-Nov-2023, the patient experienced TREMOR (Shaking uncontrollably) and CHILLS (Chills). 07-Nov-2023, the patient experienced FEELING HOT (I became very hot and removed all the warm clothes), PAIN (Aches), PAIN IN EXTREMITY (Sore arm), HEADACHE (had a slight headache for a few hours) and FATIGUE (Had a little fatigue, tired earlier than normal). On 07-Nov-2023, PAIN (Aches) had resolved. On 08-Nov-2023, TREMOR (Shaking uncontrollably), FEELING HOT (I became very hot and removed all the warm clothes), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), HEADACHE (had a slight headache for a few hours) and FATIGUE (Had a little fatigue, tired earlier than normal) had resolved.            Patient took both the COVID and Flu shots at the same time. He started with a sore arm a few hours after the shot that lasted for probably 12 hours and had a little fatigue, tired earlier than normal. About 12 hours after the shot, he woke up with chills and shaking uncontrollably, so he put on warm clothes and that stopped about 30 minutes later. He had a slight headache for a few hours and aches for 2 hours as well. Then, he became very hot and removed all the warm clothes that he had needed before. About 18 hours after getting the shot, he had slight fatigue but otherwise back to normal. Treatment information was not reported.
Age: 28.0
Sex: M
Vaccine: COVID19, FLUX
Symptoms: Pain in extremity, Tremor
Clinical narrative: Shaking uncontrollably; I became very hot and removed all the warm clothes; Aches; Sore arm; Chills; had a slight headache for a few hours; Had a little fatigue, tired earlier than normal; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (Shaking uncontrollably), FEELING HOT (I became very hot and removed all the warm clothes), PAIN (Aches), PAIN IN EXTREMITY (Sore arm) and CHILLS (Chills) in a 28-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.    Co-suspect product included non-company product INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) for an unknown indication.    The patient's past medical history included COVID-19 on 14-Jul-2022. Concomitant products included IBUPROFEN for an unknown indication.   On 07-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use) 1 dosage form and dose of INFLUENZA VACCINE (FLU [INFLUENZA VACCINE]) (unknown route) 1 dosage form. On 07-Nov-2023, the patient experienced TREMOR (Shaking uncontrollably) and CHILLS (Chills). 07-Nov-2023, the patient experienced FEELING HOT (I became very hot and removed all the warm clothes), PAIN (Aches), PAIN IN EXTREMITY (Sore arm), HEADACHE (had a slight headache for a few hours) and FATIGUE (Had a little fatigue, tired earlier than normal). On 07-Nov-2023, PAIN (Aches) had resolved. On 08-Nov-2023, TREMOR (Shaking uncontrollably), FEELING HOT (I became very hot and removed all the warm clothes), PAIN IN EXTREMITY (Sore arm), CHILLS (Chills), HEADACHE (had a slight headache for a few hours) and FATIGUE (Had a little fatigue, tired earlier than normal) had resolved.            Patient took both the COVID and Flu shots at the same time. He started with a sore arm a few hours after the shot that lasted for probably 12 hours and had a little fatigue, tired earlier than normal. About 12 hours after the shot, he woke up with chills and shaking uncontrollably, so he put on warm clothes and that stopped about 30 minutes later. He had a slight headache for a few hours and aches for 2 hours as well. Then, he became very hot and removed all the warm clothes that he had needed before. About 18 hours after getting the shot, he had slight fatigue but otherwise back to normal. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: After receiving SPIKEVAX, within 24 hours her symptoms subsided.; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (After receiving SPIKEVAX, within 24 hours her symptoms subsided.) in an adult female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 Vaccine. Past adverse reactions to the above products included Vaccination adverse reaction with COVID-19 Vaccine.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (After receiving SPIKEVAX, within 24 hours her symptoms subsided.). At the time of the report, IMMUNISATION REACTION (After receiving SPIKEVAX, within 24 hours her symptoms subsided.) had resolved.            No concomitant medication was reported.  No treatment information was reported.   This case was linked to MOD-2023-748676, MOD-2023-748677 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: RSV
Symptoms: Device breakage, Device defective, Device mechanical issue, Device physical property issue
Clinical narrative: They have tried to administered it was damaged, when they trying to put cap or something on it, it would not lock; part of the securing mechanism broke off; They have tried to administered it was damaged, when they trying to put cap or something on it, it would not lock; part of the securing mechanism broke off; When we tried to secure, when we had to push down and then turn, part of the securing mechanism broke off; The initial case was missing the following minimum criteria: No adverse effect. Upon receipt of follow-up information on 27Oct2023, this case now contains all required information to be considered valid. This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from product quality group.  A patient (no qualifiers provided) received rsv vaccine prot.subunit pref 2v (ABRYSVO), as dose number unknown, single (Lot number: HF3020, Expiration Date: Feb2025, NDC number: 0069034405) and as dose number unknown, single (Lot number: PAA209777, Expiration Date: Feb2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE PHYSICAL PROPERTY ISSUE (non-serious), DEVICE MECHANICAL ISSUE (non-serious), outcome "unknown" and all described as "They have tried to administered it was damaged, when they trying to put cap or something on it, it would not lock; part of the securing mechanism broke off"; DEVICE BREAKAGE (non-serious), outcome "unknown", described as "When we tried to secure, when we had to push down and then turn, part of the securing mechanism broke off".  Additional information: It was reported the Abrysvo was defective and a piece of glass broke off it. When they have tried to administered it was damaged. The product was damaged, when they she said when they trying to put cap or something on it, it would not lock." When they tried to push down and then turn, part of the securing mechanism broke off. So it would not secure a lock so, it had sharp edge so we have to put it on our sharp box. It was reported that a sample of the product available to be returned. Reporter stated, "It is in our sharp container, I can dig it up, I guess; "I do have piece of glass that broke of it, if you need that."  Causality for "they have tried to administered it was damaged, when they trying to put cap or something on it, it would not lock; part of the securing mechanism broke off" and "when we tried to secure, when we had to push down and then turn, part of the securing mechanism broke off" was determined associated to device constituent of rsv vaccine prot.subunit pref 2v (malfunction).  The information on the batch/lot number for rsv vaccine prot.subunit pref 2v  has been requested and will be submitted if and when received.
Sex: F
Vaccine: TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse events, no treatment required. Increased monitoring done. Vaccine not indicated in this age group.
Age: 7.0
Sex: F
Vaccine: UNK, UNK
Symptoms: Rash
Clinical narrative: Patient developed rash on neck, upper chest, back and behind ears. Provider gave child diphenhrdramine PO- no changes in conditon. Provder administed epinephrine injection and called EMS to trasnport patient to Hospital.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered a Moderna Covid-19 vaccine to a patient past it's BUD labeled on the box. Contacted manufacture to confirm data stability of the vaccine. 3-5 business turn around time to hear a response since it is lot# specific. Patients and staff were informed, no further concerns at this time.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered a Moderna Covid-19 vaccine to a patient past it's BUD labeled on the box. Contacted manufacture to confirm data stability of the vaccine. 3-5 business turn around time to hear a response since it is lot# specific. Patients and staff were informed, no further concerns at this time.
Age: 90.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered a Moderna Covid-19 vaccine to a patient past it's BUD labeled on the box. Contacted manufacture to confirm data stability of the vaccine. 3-5 business turn around time to hear a response since it is lot# specific. Patients and staff were informed, no further concerns at this time.
Age: 28.0
Sex: F
Vaccine: COVID19-2
Symptoms: Oedema peripheral
Clinical narrative: My right arm pit was swollen for three days after I got the shot and all I did was take aspirin and it took the weekend and it went away.
Age: 33.0
Sex: M
Vaccine: PNC20
Symptoms: Extra dose administered
Clinical narrative: patient given Prevnar20 in error on 11/3/2023,  received one already on 5/11/2022.
Age: 92.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered a Moderna Covid-19 vaccine to a patient past it's BUD labeled on the box. Contacted manufacture to confirm data stability of the vaccine. 3-5 business turn around time to hear a response since it is lot# specific. Patients and staff were informed, no further concerns at this time.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered a Moderna Covid-19 vaccine to a patient past it's BUD labeled on the box. Contacted manufacture to confirm data stability of the vaccine. 3-5 business turn around time to hear a response since it is lot# specific. Patients and staff were informed, no further concerns at this time.
Age: 74.0
Sex: M
Vaccine: FLUA4
Symptoms: Rash
Clinical narrative: Rash for 5 days
Age: 64.0
Sex: F
Vaccine: PNC20
Symptoms: Hypoaesthesia, Lip swelling, Paraesthesia
Clinical narrative: Patient states that her face started tingling, then became numb, and then her lip became swollen.  She took Benadryl 12 hour dose, and then again in the morning.  She contacted our office to report.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash pruritic
Clinical narrative: PT REPORTS ITCHY RASH ON BODY AND ON THE PALMS. PT WAS TOLD TO TAKE BENADRYL AND IF SYMPTOMS CONTINUE PT SHOULD CONTACT PROVIDER.
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Dizziness, Hypoaesthesia
Clinical narrative: I received the vaccine at 7:15 am, at approximately 10 am i became slightly lightheaded , so i had a soda. Through out the afternoon my hands started to become numb starting at the fingertips and working up to my hands, By 5 pm , both my hands were completely numb. I took Benadryl , Claritin and a pepcid OTC and they did nothing to help but made me sleep . I went to bed. I did not have any respiratiry symptoms. throughout the night i had multiple bouts of diarrhea and my hands cont to be numb. My cons cont to be numb t/o the day on Thurs 11/2 and inter 11/3, ending sometime in the afternoon 11/3. I did go to employee health on friday 11/3. At no time did the numbness ascend past my hands. I did contact my PCP also.  Of note, my mother had Guillian Barre when she was 58 y/o
Age: 36.0
Sex: F
Vaccine: RSV
Symptoms: Circumstance or information capable of leading to medication error, Exposure during pregnancy, No adverse event, Product use issue, Wrong product administered
Clinical narrative: I thought the Abrysvo was being administered but I pulled the Arexvy instead which was the one administered to the patient is pregnant so the Abysvo is the only one indicated in pregnancy. I spoke with patient but unaware of any adverse events at this time.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Arthropod bite, Hypersensitivity, Hypotension, Panic reaction
Clinical narrative: bitten by fire ants (about 12 bites); vomiting; impeding sense of doom; panic; hypotension; allergic response; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), on 06Apr2021 as dose 2, single (Lot number: EW0150) at the age of 61 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (ongoing); "Mood disorder" (ongoing); "Nonsmoker" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "depression" (ongoing). Concomitant medication(s) included: LISINOPRIL; MICARDIS oral taken for hypertension (ongoing); LUVOX [FLUVOXAMINE MALEATE] oral taken for depression (ongoing); LAMICTAL taken for affective disorder (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Site: "Arm". Route: Intramuscular, Lot number: EN6207.), administration date: 15Mar2021, for COVID-19 immunisation. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "allergic response"; ARTHROPOD BITE (medically significant) with onset Jun2021, outcome "unknown", described as "bitten by fire ants (about 12 bites)"; HYPOTENSION (non-serious) with onset Jun2021, outcome "recovered" (Jun2021); ANXIETY (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "impeding sense of doom"; PANIC REACTION (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "panic"; VOMITING (non-serious) with onset Jun2021, outcome "recovered" (Jun2021). The events "vomiting", "impeding sense of doom", "panic", "hypotension" and "allergic response" required emergency room visit. The event "bitten by fire ants (about 12 bites)" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of arthropod bite included Weekly fire ant venom shots. Clinical courses: In June 2021 was bitten by fire ants (about 12 bites) and needed to call 911 (vomiting, impeding sense of doom, panic, hypotension, allergic response). Recovered within an hour or two. Subsequently, sent to allergist who started fire ant venom immunotherapy.; Sender's Comments: Reported event of "Arthropod bite" is assessed as unrelated to bnt162b2 vaccine. It was reported that the patient was "bitten by fire ants (about 12 bites)".  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300318617 Same patient, different vaccine dose/events.;
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: bitten by fire ants (about 12 bites); vomiting; impeding sense of doom; panic; hypotension; allergic response; This is a spontaneous report received from a contactable reporter(s) (Pharmacist). The reporter is the patient.  A 61-year-old female patient received bnt162b2 (BNT162B2), on 06Apr2021 as dose 2, single (Lot number: EW0150) at the age of 61 years, in arm for covid-19 immunisation. The patient's relevant medical history included: "HTN" (ongoing); "Mood disorder" (ongoing); "Nonsmoker" (unspecified if ongoing); "pre-diabetic" (unspecified if ongoing); "depression" (ongoing). Concomitant medication(s) included: LISINOPRIL; MICARDIS oral taken for hypertension (ongoing); LUVOX [FLUVOXAMINE MALEATE] oral taken for depression (ongoing); LAMICTAL taken for affective disorder (ongoing). Vaccination history included: bnt162b2 (DOSE 1, SINGLE, Site: "Arm". Route: Intramuscular, Lot number: EN6207.), administration date: 15Mar2021, for COVID-19 immunisation. The following information was reported: HYPERSENSITIVITY (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "allergic response"; ARTHROPOD BITE (medically significant) with onset Jun2021, outcome "unknown", described as "bitten by fire ants (about 12 bites)"; HYPOTENSION (non-serious) with onset Jun2021, outcome "recovered" (Jun2021); ANXIETY (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "impeding sense of doom"; PANIC REACTION (non-serious) with onset Jun2021, outcome "recovered" (Jun2021), described as "panic"; VOMITING (non-serious) with onset Jun2021, outcome "recovered" (Jun2021). The events "vomiting", "impeding sense of doom", "panic", "hypotension" and "allergic response" required emergency room visit. The event "bitten by fire ants (about 12 bites)" required physician office visit and emergency room visit. Therapeutic measures were taken as a result of arthropod bite included Weekly fire ant venom shots. Clinical courses: In June 2021 was bitten by fire ants (about 12 bites) and needed to call 911 (vomiting, impeding sense of doom, panic, hypotension, allergic response). Recovered within an hour or two. Subsequently, sent to allergist who started fire ant venom immunotherapy.; Sender's Comments: Reported event of "Arthropod bite" is assessed as unrelated to bnt162b2 vaccine. It was reported that the patient was "bitten by fire ants (about 12 bites)".  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics committees and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-202300318617 Same patient, different vaccine dose/events.;
Age: 86.0
Sex: M
Vaccine: FLU4, RSV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient requested a flu vaccine at pharmacy.  Patient called us after the vaccine was given and told us he had previously got one at his physician.  A pharmacist called and notified the physician.  No known adverse affects reported.
Age: 76.0
Sex: F
Vaccine: FLUA4
Symptoms: Chills, Tremor
Clinical narrative: 4 hours after getting Fluad vaccination, I started shaking badly and had the chills.  This lasted for 4 hours, then I went to bed.  The next day 10/26/22 I felt fine.  This year 11/3/2023, I got the Fluzone High-Dose Quadrivalent and was perfectly fine (over many many past years I have received this influenza vaccine and have always been fine)
Age: 70.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pain, Pain in extremity
Clinical narrative: reaction at injection site, redness and swelling around injection site, fever,  pain (fever is now gone, patient still has very sore arm)
Age: 70.0
Sex: F
Vaccine: PNC20, RSV
Symptoms: Pyrexia
Clinical narrative: reaction at injection site, redness and swelling around injection site, fever,  pain (fever is now gone, patient still has very sore arm)
Age: 74.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Wrong product administered
Clinical narrative: Patient presented for Covid 23-24 Pfizer vaccine and Flu vaccine.  Writer verified patient's first name, last name, DOB.  Writer reviewed the Pre-Vaccination checklist for Flu and Covid with patient.  Patient reported immunocompromise and is taking CellCept.  Patient denies any allergies or severe reactions to Flu, Covid, or other previous vaccines received.  Patient denies any known allergies.  Writer asked patient if she preferred the High Dose Flu vaccine and patient stated yes.  Writer gave the Regular Flu vaccine by mistake.  Writer had both vaccine types on desk and picked up the wrong one.  Patient informed.  Dr. informed via this progress note.  Charge RN informed.  VAERS report completed and submitted.  Patient remained in clinic in observation  for approximately 20 mins.
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Fatigue, Musculoskeletal stiffness, Pyrexia
Clinical narrative: joint pain; tiredness; anywhere from upper 99+ to just above 100 +; stiffness; Initial information received on 30-Oct-2023 regarding an unsolicited valid  non-serious case received from a Pharmacist.  This case involves Elderly male patient who experienced joint pain, tiredness, anywhere from upper 99+ to just above 100 + and stiffness after receiving vaccine influenza usp trival a-b high dose subvirion vaccine [Fluzone HD].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On 26-Oct-2023, the patient received a dose of suspect influenza usp trival a-b high dose subvirion vaccine Suspension for injection in pre-filled syringe lot number not reported via intramuscular route in unknown administration site (dose, strength and expiration date: not provided) for Immunisation.  On 27-Oct-2023 the patient developed joint pain (arthralgia), tiredness (fatigue), anywhere from upper 99+ to just above 100 + (pyrexia) and stiffness (musculoskeletal stiffness) (latency- 1 day) following the administration of influenza usp trival a-b high dose subvirion vaccine.  Relevant laboratory test results included: Body temperature - On an unknown date: [anywhere from upper 99+ to just above 100 +]  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Not Recovered / Not Resolved for all the events.
Sex: U
Vaccine: FLU4
Symptoms: Back pain, Illness, Malaise, Vomiting
Clinical narrative: allergy/adverse reaction to the vaccine; felt very sick for a day and a half with back ache; felt very sick for a day and a half with back ache; vomiting; Initial information received on 25-Oct-2023 regarding an unsolicited valid non-serious case received from a Nurse.  This case involves an unknown age and unknown gender patient who had allergy/adverse reaction to the vaccine, felt very sick for a day and a half with back ache and vomiting after receiving 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 an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot U8192DA, expiry date: 30-Jun-2024, Dosage strength: 0.5 ml) via unknown route in unknown administration site for immunization.  On an unknown date the patient had allergy/adverse reaction to the vaccine (allergy to vaccine), felt very sick for a day and a half with back ache (illness) (back pain) and vomiting (unknown latency).  Reportedly, administered FLUZONE QUADRIVALENT NP to two of their patients and both of them had an allergy/adverse reaction to the vaccine. The nurse also reported that both patient had an anti-allergy shot before taking the flu shot.  Action taken: not applicable.  It was not reported if the patient received a corrective treatment for the events   Outcome was Unknown for all the events.  A Product Technical Complaint (PTC) was initiated on 25-Oct-2023 for FLUZONE QIV (quadrivalent influenza vaccine) (lot/batch number: U8192DA, expiry date: 30-Jun-2024) with Global PTC number:  The sample status of the PTC was Requested & Awaited Site Sample Status: Not Received Issue Status: Completed  PTC stated- INVESTIGATION FORWARDED This report has been forwarded to the pharmacovigilance department for registration in the Sanofi global safety database. If the Global Safety Officer decides that a manufacturing investigation is needed, it will be performed by the quality team of the manufacturing site per SWV-QU-WIN-0003203, Manufacturing Investigations in Response to Adverse Events and GMCCQ-QU-WIN-0047713, Global  Manufacturing Lot Review.  Conclusion: The final investigation was completed on 27-Oct-2023 with summarized conclusion as evaluation not possible.  Additional information was received on 27-Oct-2023 from the quality department. PTC details, Batch number, Expiry date, Dosage strength were added. Text amended accordingly.
Sex: U
Vaccine: FLU3
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: patients received the wrong dose/double dosage of fluzone qiv with no reported adverse event; Initial information received on 27-Oct-2023 (with live follow up processed together CSD: 27-OCT-2023) regarding an unsolicited valid non-serious case received from other health professional.  This case involves an unknown age and unknown gender 51 patients who received the wrong dose/double dosage of influenza quadrival A-B multidose vaccine preserved [Fluzone QIV] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   In October 2023, the patients received a standard dose of suspect influenza quadrival A-B multidose vaccine preserved Suspension for injection at a dose of 1 mL (lot U80968A, expiry date- 30-JUN-2024) via unknown route in unknown administration site for Immunization.  In OCT-2023 the patients received the wrong dose/double dosage of influenza quadrival A-B multidose vaccine preserved with no reported adverse event (incorrect dose administered) (latency- same day).  Reportedly, She reports that they have been administering 1 mL of FLUZONE QIV , not 0.5 mL of FLUZONE QIV. Office manager mentioned that the vaccination happened from 06Oct2023 to 25Oct2023. No further patient and event information was provided during the call.  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: 0.67
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: inadvertently administered an expired ACT-HIB dose to a patient earlier today with no reported adverse event; Initial information was received on 27-Oct-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves 8 months old female patient who received inadvertently administered an expired hib (prp/t) vaccine [ACT-HIB] dose to a patient earlier today 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, HIB VACCINE CONJ (TET TOX), PERTUSSIS VACCINE ACELLULAR 5-COMPONENT, POLIO VACCINE INACT 3V (MRC 5), TETANUS VACCINE TOXOID (Pentacel) for Prophylactic vaccination; DIPHTHERIA VACCINE TOXOID, hepatitis b vaccine RHBSAG (YEAST), PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, POLIO VACCINE INACT 3V (VERO), TETANUS VACCINE TOXOID (Pediarix) for Prophylactic vaccination; influenza vaccine INACT SPLIT 4V (Fluzone QUADRIVALENT) for Prophylactic vaccination; and pneumococcal vaccine CONJ 13V (CRM197) (Prevnar 13) for Prophylactic vaccination.  On 27-Oct-2023, the patient received a dose of 0.5 ml of suspect hib (prp/t) vaccine (Powder and solvent for solution for injection) (lot UJ801AA, Expiry date : 05-Oct-2023, Frequency : once, strength was unknown) via unknown route in unknown administration site for Immunization and inadvertently administered an expired act-hib dose to a patient earlier today with no reported adverse event (expired product administered) (latency : same day).  Action taken with haemophilus type b (hib) vaccine (ACT-HIB) was not applicable.  At time of reporting, the outcome was Unknown for the event inadvertently administered an expired act-hib dose to a patient earlier today with no reported adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Bradykinesia, Mobility decreased, Muscle disorder, Muscular weakness
Clinical narrative: moving in slow motion; could not control her muscle/could not move very well/moving like jello; muscle weakness; Initial information received on 27-Oct-2023 regarding an unsolicited valid non-serious case received from patient.  This case involves a 77 years old female patient who experienced muscle weakness, moving in slow motion and could not control her muscle/could not move very well/moving like jello after receiving vaccine Influenza Quadrival A-B High Dose HV vaccine [Fluzone High-Dose Quadrivalent].  The patient's past vaccination(s) included FLUZONE HIGH DOSE Quadrivalent in 2022 and COVID-19 vaccine  The patient's past medical history and family history were not provided.  On 07-Sep-2023, the patient received 0.7 ml high dose (frequency: once) of suspect Influenza Quadrival A-B High Dose HV vaccine (formulation, lot number and expiry: not reported) via unknown route in unknown administration site for immunization. Information on the batch number was requested.  On 08-Sep-2023, the patient developed muscle weakness (muscular weakness), moving in slow motion (bradykinesia) and could not control her muscle/could not move very well/moving like jello (dyskinesia) 1 day following the administration of Influenza Quadrival A-B High Dose HV vaccine.  Reportedly, patient reported that she received a FLUZONE HIGH DOSE Quadrivalent on 07September2023 and the next day, 08September2023 she had an episode of "moving like jello". She says it seems like she was moving in slow motion, and could not control her muscle. She also says there's muscle weakness and she could not move very well. She says it resolved on the same day however, after 5 days, she had another similar episode so she decided to go to ER. Patient is stating these episodes are adverse event of FLUZONE HIGH DOSE Quadrivalent because that's the only product administered to her prior the episodes. She says she had received several vaccines in the past, but this is the only vaccine that caused her this event. She says she remembered getting a COVID vaccine in the past that caused her adverse reaction, too, but she says it was as expected. She then says she remember receiving FLUZONE HIGH DOSE Quadrivalent in 2022 as her flu shot, but this event never occurred back then.  No lab data was reported.  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for all events.  At time of reporting, the outcome was Unknown for all events.
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: patient inadvertently received 2 doses of fluzone high dose quadrivalent with no adverse event; Initial information was received on 28-Oct-2023 regarding an unsolicited valid  non-serious case received from a pharmacist. This case involves Elderly unknown gender patient who inadvertently received 2 doses of influenza quadrival a-b high dose hv vaccine [fluzone high-dose quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received inadvertently 2 dose of suspect influenza quadrival a-b high dose hv vaccine (lot, dose, formulation, strength, and expiry date: unknown) (extra dose administered) (latency same day) via unknown route in unknown administration site for prophylactic vaccination (immunization  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.