chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 11.0
Sex: M
Vaccine: MEN
Symptoms: Urticaria
Clinical narrative: hives after the injection last friday; Initial information received on 03-Nov-2023 regarding an unsolicited valid non-serious case received from a Non-Healthcare Professional.  This case involves a 11 years old male patient who experienced hives after the injection last friday after receiving meningococcal a-c-y-w135 (t conj) vaccine [Menquadfi].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included influenza vaccine (Flu vaccine VII) and diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (TDAP) for Prophylactic vaccination.  On 27-Oct-2023, the patient received a dose of suspect meningococcal a-c-y-w135 (t conj) vaccine Solution for injection lot number not reported via intramuscular route in the arm nos (dose, strength and expiration date: not provided) for Immunisation.  On an unknown date the patient developed hives after the injection last friday (urticaria) (unknown latency) following the administration of meningococcal a-c-y-w135 (t conj) vaccine.  Action taken- not applicable.  It was not reported if the patient received a corrective treatment for the event.  At time of reporting, the outcome was Unknown for the event hives.
Age: 67.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Cyanosis, Headache
Clinical narrative: as having a headache for a couple of days after receiving Flu shot; within 5 minutes, the "nail beds on her left hand turned blue".; Initial information received on 06-Nov-2023 regarding an unsolicited valid  non-serious case received from a consumer/non-hcp.  This case involves a 67 years old female patient who experienced within 5 minutes, the "nail beds on her left hand turned blue". and as having a headache for a couple of days after receiving Influenza Quadrival A-B High Dose HV Vaccine [Fluzone High-Dose Quadrivalent].  The patient's past medical history included Arteriovenous fistula operation with in her left upper arm. The patient's past medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Renal disorder NOS.   On 11-Oct-2023, the patient received a 0.7 ml dose of suspect Influenza Quadrival A-B High Dose HV Vaccine (lot UT80726A, expiry date: 06-Jan-2024 with unknown strength and form) via unknown route in the right deltoid as prophylactic vaccination.  On 11-Oct-2023 the patient developed within 5 minutes, the "nail beds on her left hand turned blue" (nail discolouration) following the administration of Influenza Quadrival A-B High Dose HV Vaccine . On an unknown date the patient developed a headache for a couple of days after receiving (headache) (unknown latency) Influenza Quadrival A-B High Dose HV Vaccine.  It was reported "Caller reports that her "fingers turned black and blue like she had been beaten up". Caller informed the staff, and they came to sit with her to monitor her condition. After 30 minutes, the bed of fingernails went back to normal. The discoloration on fingers looked like bruises and returned to normal after some time. The only other thing she reported was having a headache for a couple of days after receiving Flu shot, but she is not sure if that was contributed by the flu shot."  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 Recovered / Resolved on 11-Oct-2023 for the event within 5 minutes, the "nail beds on her left hand turned blue". and was Unknown for the event as having a headache for a couple of days after receiving flu shot.
Age: 1.25
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Product preparation error
Clinical narrative: only received the diluent and not the lyophilized powder portion (with no reported adverse event); Initial information received on 06-Nov-2023 regarding an unsolicited valid non-serious case received from a pharmacist.  This case is linked to cases 2023SA343804, 2023SA343809 and 2023SA343771.  This case involves a 15-months-old female patient who only received the diluent and not the lyophilized powder portion for HIB (PRP/T) vaccine [ACT-HIB] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included diphtheria vaccine toxoid, pertussis vaccine acellular, tetanus vaccine toxoid (Daptacel); hepatitis A vaccine (Hepatitis A); and Influenza Vaccine for Prophylactic vaccination.  On 27-Oct-2023, the patient received a standard dose 4 of suspect HIB (PRP/T) vaccine, Powder and solvent for solution for injection at a dose of 0.5 ml total (lot: UK007AB, expiry date: 31-Dec-2024) via intramuscular route in the right thigh for Immunization; only received the diluent and not the lyophilized powder portion with no reported adverse event (single component of a two-component product administered) (same day latency).  Reportedly, Pharmacist reported that four patients received a dose of ACTHIB. However, one patient only received the diluent and not the lyophilized powder portion. They noticed there was one extra powder vial left but they are unsure which patient only received the diluent. Should they revaccinate all or should they do serologic testing prior to re-administering? Treatment: The caller was not aware of any adverse reactions, treatment.  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: 0.17
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP called to report inadvertent administration of expired ROTATEQ to a 2-month-old patient. Product expired on 14OCT2023 and was administered on 08NOV2023. No additional AE/PQC.; HCP called to report inadvertent administration of expired ROTATEQ to a 2-month-old patient. Product expired on 14OCT2023 and was administered on 08NOV2023. No additional AE/PQC.; This spontaneous report was received from a registered medical assistant concerning to a 2-month-old patient of unknown gender. The patient's medical history, concurrent conditions, and concomitant therapies were not reported.  On 08-NOV-2023, the patient was inadvertently vaccinated with an expired dose of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, 2 mL, once, lot #1837127, expiration date: 14-OCT-2023, as prophylaxis (Expired product administered). No additional adverse event (AE) reported.
Age: 56.0
Sex: F
Vaccine: COVID19, FLUX
Symptoms: Erythema, Feeling hot, Gastroenteritis viral, Rash, Weight
Clinical narrative: stomach flu/stomach bug; Rash on the right side of her abdomen that spread; warm to the touch [Localised feeling of warmth]; redness; Initial information received from United States on 04-Nov-2023 regarding an unsolicited valid non-serious case received from a Patient. This case is courtesy received from Regulatory Authority.  This case involves a 56 years old female patient (87.7 kg) who experienced stomach flu/stomach bug, rash on the right side of her abdomen that spread, warm to the touch [localised feeling of warmth] and redness after receiving vaccines moderna covid-19 vaccine and influenza vaccine.  The patient's past medical treatment included Remodulin.  The patient's past medical history, vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Pulmonary arterial hypertension.  Concomitant medications included bifidobacterium lactis (probiotic [bifidobacterium lactis]); curcuma longa (turmeric [curcuma longa]); prednisone (prednisone); levothyroxine sodium (unithroid); fluticasone furoate, umeclidinium bromide, vilanterol trifenatate (trelegy); tadalafil (tadalafil); carvedilol (carvedilol); atorvastatin (atorvastatin); cyanocobalamin (vitamin b12 [cyanocobalamin]); metformin (metformin); rabeprazole (rabeprazole); iron (iron); oxygen (oxygen); valsartan (valsartan); calcium (calcium); magnesium (magnesium); ascorbic acid (vitamin c [ascorbic acid]); salbutamol (albuterol [salbutamol]); furosemide (lasix [furosemide]); montelukast (montelukast); cetirizine hydrochloride, pseudoephedrine hydrochloride (zyrtec-d); guaifenesin (mucinex); rosuvastatin calcium (crestor); ambrisentan (ambrisentan); hydrochlorothiazide, spironolactone (spironolactone and hydrochlorothiazide); ergocalciferol (vitamin d2); vitamin b nos (b complex [vitamin b nos]); empagliflozin (jardiance); and magnesium sulfate (epsom salt).  On 15-Oct-2023, the patient received a dose of suspect influenza vaccine produced by unknown manufacturer lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation.  On an unknown date, the patient received a dose of suspect moderna covid-19 vaccine not produced by Sanofi Pasteur lot number not reported via unknown route in unknown administration site (dose, formulation, strength and expiration date: not provided) for Immunisation.  On an unknown date and month in 2023 the patient developed stomach flu/stomach bug (gastroenteritis viral), rash on the right side of her abdomen that spread (rash), warm to the touch [localised feeling of warmth] (feeling hot), redness (erythema) (unknown latency) following the administration of influenza vaccine and moderna covid-19 vaccine.  Relevant laboratory test results included: Weight - In September 2023:  [182.6 lbs]; in October 2023:  [183 lbs]  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 Unknown for all the events.
Age: 6.0
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 6 year old client that we serviced was recently given a Pentacel vaccine. Since they were given the vaccine over the age indication with no reported adverse event; Initial information received on 08-Nov-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 6 years old and unknown gender patient who was recently given a DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(VERO)/HIB(PRP/T) VACCINE [PENTACEL (VERO)] vaccine since they were given the vaccine over the age indication with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, 6 year old client that we serviced was recently given a pentacel vaccine. since they were given the vaccine over the age indication with no reported adverse event (product administered to patient of inappropriate age) (latency: same day)(Suspension for injection) (lot number and expiry date not reported) via unknown route in unknown administration site for prophylactic vaccination (Immunization). Information on the batch number was requested.   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: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased, Pain
Clinical narrative: Patient states he is still having shoulder pain, unable to lift shoulder and arm above head without pain which started after getting vaccinated
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Dyspnoea
Clinical narrative: Pt stated that he got the vaccine and then hours later pt had issues breathing and had to call EMS and be rushed to the hospital. Pt has history of COPD. Pt was unsure if this is vaccine related or if this occurred from another underlying issue.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Given the high dose instead of regular dose for her age.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus
Clinical narrative: Patient complains of itching and pain since receiving covid vaccine over 1 month ago.
Age: 33.0
Sex: U
Vaccine: FLUC4
Symptoms: Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased, Muscular weakness, Pain
Clinical narrative: Left shoulder pain at time of injection that has persisted 6 weeks with accompanying pain with abduction and limited range of motion of left shoulder and reduced grip strength.
Age: 59.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis, Rash, Rash erythematous
Clinical narrative: patient presented with red rash on her arm.  she went to urgent care and was diagnosed with cellulitis post vaccination.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Skin exfoliation, Vaccination site bruising, Vaccination site discolouration, Vaccination site erythema, Vaccination site induration
Clinical narrative: patient came in approximate 5 days after vaccine with vaccine site on left upper arm swollen, hard, and, red and purple. Vaccine site bruised (aproximately 1 cm round) with skin removed.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling
Clinical narrative: patient came in approximate 5 days after vaccine with vaccine site on left upper arm swollen, hard, and, red and purple. Vaccine site bruised (aproximately 1 cm round) with skin removed.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Chest pain, Cold sweat, Headache, Pyrexia
Clinical narrative: HEADACHE, CHEST PAIN, FEVER, FEELING CLAMMY
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site discolouration, Injection site induration, Injection site inflammation, Injection site swelling
Clinical narrative: Patient had 2 inch wide raised, hard, and inflamed area where vaccine was given. It started to turn purple. Patient was monitored for 30 minutes and told to take Benadryl when she went home. She did not want to take Benadryl in the store because she was worried she would get drowsy before she got home. Only issue was inflamed area.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Haemorrhage, Mass, Pain, Swelling
Clinical narrative: Patient had 2 inch wide raised, hard, and inflamed area where vaccine was given. It started to turn purple. Patient was monitored for 30 minutes and told to take Benadryl when she went home. She did not want to take Benadryl in the store because she was worried she would get drowsy before she got home. Only issue was inflamed area.
Age: 58.0
Sex: U
Vaccine: PNC20
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Left arm pain after vaccine in 3/2023.  Upper arm pain is constant with forearm pain with hand movement.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Expired fluarix was administered. Exp: 6/30/23
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Anxiety, Dyspnoea, Flushing, Pharyngeal swelling, Swollen tongue
Clinical narrative: Pt at COVID vaccination clinic to receive Pfizer 20234-34 monovalent COVID vaccine. Patient visibly anxious with vaccinating nurse during screening questions; was physically jittery, talkative, and stating that they had a very stressful three months. Screening questions all responded in the negative and patient vaccinated in their left arm at 1655. Pt counseled to stay for 15 minutes after vaccination, per protocol. At 1725 patient noticed to still be in observation area and pacing. When approached by this nurse, patient stated they were "having an anxiety attack". Pt noted to be flushed in the face, denied any difficulty breathing, shortness of breath or throat/tongue swelling. Pt accompanied to a cubicle where VS taken. BP 128/98, HR 101, SaO299% on room air. Pt states "These are my symptoms when I have an anxiety attack, but I've never had it happen after getting vaccinated." Advised patient to take slow deep breaths, with pt appearing more calm and flushing in face starting to recede within several minutes.Agreed with patient to focus on breathing and calming techniques over the next 15 minutes at which point VS would be rechecked. After 15" pt states they feel much better. BP 128/96, HR 77, SaO2 99% on room air, flushing in face gone. Pt states that they were planning on taking the bus home, as that was their usual mode of transportation. Bus scheduled to arrive in 11 minutes. Pt stated that they felt well enough to go wait for bus. Pt counseled that if at any time while waiting for bus they felt unwell to come back in . Pt verbalized understanding and out of clinic ambulatory and unaccompanied at 1750.
Age: 0.17
Sex: F
Vaccine: RV1, RV1
Symptoms: No adverse event, Product preparation error, Single component of a two-component product administered
Clinical narrative: I was asked by CMA to assist with pediatric vaccines as she has never given VFC vaccines before. I verified the orders and then went to the medication room where CMA already had the vaccines laid out. I assisted her with scanning and order entry for the vaccines.  Vaccines were given to pt. I advised CMA that we needed to correct the Rotarix order so that she could document the Rotarix as I had forgotten to scan the box instead of the vial since the vaccine needed to be mixed. We do have both the premixed Rotarix and the powder vaccine that needs to be reconstituted with the accompanying diluent. Immediately after scanning the syringe that CMA had out, I noticed that she hadn't gotten out the powder vial that goes along with it.  I retrieved the vial as I was explaining to CMA that the two get mixed together to make the vaccine that was to be given. The two were mixed together prior to being given to the pt.  It was upon scanning the box for the 2 part Rotarix vaccine that I realized that the syringe that CMA pulled was from the new premixed vaccine box as the lot number was different. As the VFC coordinator, I had checked inventory levels of VFC vaccines just prior to this occurrence. At that time, the premixed Rotarix had not yet been opened so it did not occur to me to double check the syringe myself in case the premixed box of vaccines had been opened and the syringe pulled from it. Dr was made aware per myself. The inpatient pharmacy was contacted and staff advised that the parents should be made aware that vomiting, diarrhea and fussiness are to be watched for. The mother verbalized understanding and was agreeable to taking the pt to the ER should any bad side effects occur. I will contact the mother in the am to check on the pt myself. VAERS reporting is being completed as well as a note in the pt's chart.  Pt has yet to experience any adverse effects as this moment in time.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 2nd season flu shot this season. no true adverse reactions noted. no treatment required
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain, Swallow study abnormal
Clinical narrative: BEGINNING ON 11/12/23,  SYMPTOMS INCLUDE SORENESS, REDNESS TO SITE.  WARM TO TOUCH.  HAS BEEN USING ICE PACKS AND TYLENOL FOR PAIN AND SWELLING.
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: It was discovered that the patient who is 16 years old was given Flublok. This is indicated for individuals age 18 years and older.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in jaw, Toothache, X-ray dental normal
Clinical narrative: Tooth and jaw pain.
Age: 75.0
Sex: F
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Pain in extremity, Sleep disorder
Clinical narrative: Very sore upper arm since the day of the injection.  Arm has gotten progressively worse.  It feels like a toothache all the time.  I can't sleep on my left side.  It's getting harder to lift anything or to reach up  and to move it normally.  (I am also left-handed, which makes it worse).  I have been taking physical therapy with a "hand and upper body" specialist/ therapist for several months now.
Age: 28.0
Sex: F
Vaccine: RSV
Symptoms: Abnormal cord insertion, Exposure during pregnancy, High risk pregnancy, Premature delivery, Preterm premature rupture of membranes
Clinical narrative: PPROM at 36 weeks and 4 days - 3 days after vaccine. High risk pregnancy  due to a marginal cord insertion.  EDD 11/16/2023. Birth weight - 5lbs 10oz
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event, Product administration error
Clinical narrative: No known adverse reaction. This is more of an administration error. The patient received a Pnuemovax23 dose at another facility on 10-12-2020 per website. He was given another dose at pharmacy on 09-21-22, when based on age and history, the Prevnar13 was more appropriate to give if needed.
Age: 0.58
Sex: F
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Injection site induration, Injection site mass, Injection site swelling
Clinical narrative: Swelling, hard lump at injection site
Age: 81.0
Sex: M
Vaccine: COVID19, FLUA4
Symptoms: Injected limb mobility decreased, Pain
Clinical narrative: patient stated he has been experiencing pain since the date he got the vaccines administered. He stated it's difficult to lift his arm that the vaccines were administered in.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Mobility decreased, Musculoskeletal stiffness, Myalgia, Tremor
Clinical narrative: Around 20:00 on 11/12/2023, started to become stiff, having difficulty to move my body.    About an hour later, I started to experience chills and began shaking uncontrollably.  I did take 500 mg of Tylenol, laid into bed, covering myself with blanket and suffered.  The next day, I could still barely move, took more Tylenol, and slept until 13:00 on 11/13/2023.  Through the remainder of the day, I started to feel better.  By that evening, I could move normally though my arms and legs muscles were sore, as if I had been lifting weights.  While the soreness has started to diminish, it is still present at the time and date of this report.  I have still not fully recovered.
Age: 59.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Myalgia
Clinical narrative: The patient seems to have a long term adverse reaction to the Moderna Covid vaccine.  He has been experiencing generalized muscle soreness and fatigue for weeks since the immunization was administered.  The only change was that he has received Pfizer in the past and received Moderna for this vaccination.  He says it is slowly getting better.
Age: 2.0
Sex: F
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Erroneous dosage was given. This was a multi-dose vial. But the nurse just drew up all the contents (without diluting it) and then administered the entire contents in the injection.  She was not aware that this was a multi-dose vial.
Age: 17.0
Sex: F
Vaccine: COVID19-2
Symptoms: Abdominal pain, Dizziness, Presyncope, Vomiting
Clinical narrative: patient had vasovagal response to flu and covid vaccine. Patient was lightheaded and dizzy following vaccine and felt she would pass out. 15 minutes later, patient VOMITED once and reported severe abdominal pain for ~30 minutes. Medics evaluated and assessed patient and gave the all clear once symptoms resolved
Age: 8.0
Sex: M
Vaccine: COVID19, FLUC4
Symptoms: Head injury, Syncope
Clinical narrative: syncope post vaccination. hit head. called rescue
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Dyspnoea, Hypersensitivity, Rash, Swollen tongue
Clinical narrative: Developed a rash around mid-section that started to spread over the body.  Tongue swelled up causing breathing problems.  EMS was called and patient was seen in the ER for an allergic reaction.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Diarrhoea, Flushing, Hypersensitivity, Injection site erythema, Injection site swelling
Clinical narrative: Patient received menveo vaccine and almost immediately developed a local area of redness/swelling at shot site approximately silver dollar sized, within a few minutes she had facial flushing, itchy eyes, slight discomfort in her throat and 1 episode of diarrhea in office.  She was given Benadryl 25mg initially but then another 25mg due to some progression of symptoms.  She was observed for 45 minutes and had stable vital signs and no further progression of symptoms, her local swelling at the shot site resolved.  She was discharged from clinic but suspected to have had an acute hypersensitivity reaction to the vaccine.  Phone f/u the next day revealed her symptoms had resolved.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Oropharyngeal discomfort
Clinical narrative: Patient received menveo vaccine and almost immediately developed a local area of redness/swelling at shot site approximately silver dollar sized, within a few minutes she had facial flushing, itchy eyes, slight discomfort in her throat and 1 episode of diarrhea in office.  She was given Benadryl 25mg initially but then another 25mg due to some progression of symptoms.  She was observed for 45 minutes and had stable vital signs and no further progression of symptoms, her local swelling at the shot site resolved.  She was discharged from clinic but suspected to have had an acute hypersensitivity reaction to the vaccine.  Phone f/u the next day revealed her symptoms had resolved.
Age: 96.0
Sex: F
Vaccine: COVID19
Symptoms: Death, Peripheral swelling, Thrombosis, Vaginal haemorrhage
Clinical narrative: About a week after first vaccine developed swelling in her left foot.  About a week after the second vaccine  she experience vaginal bleeding (blood clots).  Subsequently was placed in home hospice, given opioids and died
Age: 82.0
Sex: F
Vaccine: FLU4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: customer did not have adverse event, this is to report she received 2nd flu shot this season. Her first regular flu shot she received from her dr."s office on 09/18/2023 and when she came to our pharmacy she did not remember she already had one. she received Fluzone HD from our pharmacy
Age: 34.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Amenorrhoea, Antinuclear antibody, Autoimmune disorder, Laboratory test, Menstruation irregular
Clinical narrative: Periods stopped- despite still being on birth control. Even on the ?off? week there is no bleeding. For the last 20 years I?ve taken that medication and always bled that week. But about 3 months after the vaccine I stopped bleeding for that off week, but will sporadically bleed a few days during the month.  Also have an autoimmune disease now. Had lots of symptoms starting in November 2022 and bloodwork in April and again in May of 2023 that confirm an autoimmune disease. Waiting to see a specialist to determine which one I have. Never had a history of that before.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Contusion, Erythema, Mobility decreased, Pain in extremity
Clinical narrative: Pt reports some redness after the shot, 2 days later she had bruising all over down to her elbow, pain into her armpit and difficulty lifting her arm. She reported this to the pharmacy 11/15/23 shot given 11/8/23. Pt had a video visit with a doctor, but the doctor could not asses her arm without seeing it to examine. The doctor recommended the patient report to urgent care to have it checked a few days ago. Pt did not go to urgent care or seek additional treatment. The pharmacy recommended she still be seen to have her arm evaluated medically. She stated it was slightly better still painful and she has difficulty lifting her arm above her head. She is using ice and heat for pain.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Complex regional pain syndrome, Hypoaesthesia, Laboratory test normal, Local reaction, Magnetic resonance imaging head normal
Clinical narrative: She received menveo vaccine 1/19/23.  Within 1-2 days of vaccine she developed a large local reaction that then resolved.  Approximately 1 mo later and during a time of possible COVID infection she developed unilateral hand and foot numbness/tingling and inability to bear weight.  She had a hospital admission and was diagnosed with suspected peripheral neuropathy or complex regional pain syndrome.  She had persistent symptoms for approximately 2 months and then completely cleared 1 day and has not returned.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Magnetic resonance imaging normal, Magnetic resonance imaging spinal normal, Neuropathy peripheral, Paraesthesia, Weight bearing difficulty
Clinical narrative: She received menveo vaccine 1/19/23.  Within 1-2 days of vaccine she developed a large local reaction that then resolved.  Approximately 1 mo later and during a time of possible COVID infection she developed unilateral hand and foot numbness/tingling and inability to bear weight.  She had a hospital admission and was diagnosed with suspected peripheral neuropathy or complex regional pain syndrome.  She had persistent symptoms for approximately 2 months and then completely cleared 1 day and has not returned.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: X-ray normal
Clinical narrative: She received menveo vaccine 1/19/23.  Within 1-2 days of vaccine she developed a large local reaction that then resolved.  Approximately 1 mo later and during a time of possible COVID infection she developed unilateral hand and foot numbness/tingling and inability to bear weight.  She had a hospital admission and was diagnosed with suspected peripheral neuropathy or complex regional pain syndrome.  She had persistent symptoms for approximately 2 months and then completely cleared 1 day and has not returned.
Age: 0.83
Sex: M
Vaccine: RV5
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 10 month old received 3rd dose of rotavirus; should not be given after 8 months of age ; no adverse reaction occurred.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Expired flu vaccine given
Age: 81.0
Sex: F
Vaccine: RSV
Symptoms: Erythema, Swelling
Clinical narrative: has a bigger than a beebee smaller than a pea size red bump.  it hurts.  She did have a flu and covid shot in same arm one per week the 2 weeks before this.
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Cyanosis, Lip swelling, Pruritus, Upper respiratory tract infection, Urticaria
Clinical narrative: Lips swelled turned blueish in color, whole body became itchy, broke out in hives went to ER, was given Prednisone and then Benadryl at home, returned to PCP the next morning for a Rx of Prednisone and more Benadryl very mild URI without fever and "felt good". Has had flu vaccine 11 years in a row. Last COVID vax 5/22. No other known allergies or anything else new in the date of incident. Still persistent hives Day 4 with Benadryl and Prednisone. Added Zyrtec and ranitidine Day 2/3/4
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Diarrhoea, Dry throat, Fatigue, Hypophagia, Mobility decreased
Clinical narrative: Fatigue, Dry Heaves, Slight Diarrhea, 101.8 fever,Throat Dryness. Remained in bed for 36 hours before I had energy to get out of bed.Fatigue lasted approx 72 hours. Drank water. Ate very,very little.
Age: 75.0
Sex: M
Vaccine: RSV
Symptoms: Pyrexia, Retching
Clinical narrative: Fatigue, Dry Heaves, Slight Diarrhea, 101.8 fever,Throat Dryness. Remained in bed for 36 hours before I had energy to get out of bed.Fatigue lasted approx 72 hours. Drank water. Ate very,very little.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction, Vomiting
Clinical narrative: MASSIVE HEART ATTACK; THROWING UP VIOLENTLY; This spontaneous report received from a consumer concerned a female of unspecified age. Initial information was processed along with the additional information received on 13-NOV-2023. The patient's height, and weight were not reported. The patient's concurrent conditions included: disabled, and other pre-existing medical conditions included: The patient had never thrown up violently before. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose was not reported, 1 total administered at right arm on 29-JUN-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On unspecified date in 2021, after vaccination she was throwing up violently. The patient passed away due to a massive heart attack on 13-OCT-2021. The patient got the vaccine at home because she was disabled. It was unspecified if an autopsy was performed. Reporter stated that his wife had never done that (thrown up violently) before, it was like a volcanic eruption. Massive throwing up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the throwing up violently was not reported. This report was serious (Death). This report was associated with a product quality complaint 90000303423. The suspected product quality complaint has been confirmed to be the reported event was not associated with a product defect or product performance issue. This customer preference case has been assessed and did not represent a product quality complaint based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20231130987-Massive heart attack. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.; Reported Cause(s) of Death: MASSIVE HEART ATTACK
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Blood test, Investigation, Magnetic resonance imaging, Psychotic disorder, Schizophrenia
Clinical narrative: suicidual thoughts, hospitalized many times for psychosis, catatonia, Schizophrenia.  prior to vaccine I was a functional adult working full time, college and now I can only work part time (with father)
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Catatonia, Impaired work ability, Loss of personal independence in daily activities, Psychotic disorder, Schizophrenia
Clinical narrative: suicidual thoughts, hospitalized many times for psychosis, catatonia, Schizophrenia.  prior to vaccine I was a functional adult working full time, college and now I can only work part time (with father)
Age: 27.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Suicidal ideation
Clinical narrative: suicidual thoughts, hospitalized many times for psychosis, catatonia, Schizophrenia.  prior to vaccine I was a functional adult working full time, college and now I can only work part time (with father)
Age: 13.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Incorrect vaccine given per age
Age: 13.0
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Incorrect vaccine given per age
Sex: F
Vaccine: COVID19-2, COVID19
Symptoms: Chills, Fear, Heavy menstrual bleeding, Pyrexia, Vaginal haemorrhage
Clinical narrative: Really heavy period; Heart rate was really high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious) with onset 07Nov2023, outcome "unknown", described as "Heart rate was really high"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "Really heavy period". Additional information: Consumer stated, "I got the Pfizer vaccine for COVID on this past Tuesday (07Nov2023) and I am having some different side effects form that, I do not know if they have been reported before but I have my period and it is really heavy which is not normal and also the day I got my vaccine I have a really high heart rate."  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: F
Vaccine: COVID19-2, COVID19
Symptoms: Heart rate increased, Heavy menstrual bleeding
Clinical narrative: Really heavy period; Heart rate was really high; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A female patient received bnt162b2 omi xbb.1.5 (COMIRNATY (2023-2024 FORMULA)), on 07Nov2023 as dose 1, single (Lot number: Unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: HEART RATE INCREASED (non-serious) with onset 07Nov2023, outcome "unknown", described as "Heart rate was really high"; HEAVY MENSTRUAL BLEEDING (non-serious), outcome "unknown", described as "Really heavy period". Additional information: Consumer stated, "I got the Pfizer vaccine for COVID on this past Tuesday (07Nov2023) and I am having some different side effects form that, I do not know if they have been reported before but I have my period and it is really heavy which is not normal and also the day I got my vaccine I have a really high heart rate."  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: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: pain in my ankles; Pain is severe at times and greatly affects my mobility; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received bnt162b2 (BNT162B2), on 08Dec2021 at 09:00 as dose 3 (booster), single (Lot number: CUS2096) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ. Vaccination history included: bnt162b2 (Dose 2, lot unknown reason: not available), administration date: 04Mar2021, when the patient was 56-year-old, for COVID-19 immunization; covid-19 vaccine (Dose 1, dose lot unknown reason: not available), administration date: 25Mar2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: MOBILITY DECREASED (non-serious) with onset 12Feb2022 at 13:00, outcome "not recovered", described as "Pain is severe at times and greatky affects my mobility"; ARTHRALGIA (non-serious) with onset 12Feb2022 at 13:00, outcome "not recovered", described as "pain in my ankles". The events "pain in my ankles" and "pain is severe at times and greatly affects my mobility" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, mobility decreased.
Age: 56.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Magnetic resonance imaging, Mobility decreased
Clinical narrative: pain in my ankles; Pain is severe at times and greatly affects my mobility; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 56-year-old male patient received bnt162b2 (BNT162B2), on 08Dec2021 at 09:00 as dose 3 (booster), single (Lot number: CUS2096) at the age of 56 years, in right arm for covid-19 immunisation. The patient's relevant medical history included: "Arthritis" (unspecified if ongoing). Concomitant medication(s) included: XELJANZ. Vaccination history included: bnt162b2 (Dose 2, lot unknown reason: not available), administration date: 04Mar2021, when the patient was 56-year-old, for COVID-19 immunization; covid-19 vaccine (Dose 1, dose lot unknown reason: not available), administration date: 25Mar2021, when the patient was 56-year-old, for COVID-19 immunization. The following information was reported: MOBILITY DECREASED (non-serious) with onset 12Feb2022 at 13:00, outcome "not recovered", described as "Pain is severe at times and greatky affects my mobility"; ARTHRALGIA (non-serious) with onset 12Feb2022 at 13:00, outcome "not recovered", described as "pain in my ankles". The events "pain in my ankles" and "pain is severe at times and greatly affects my mobility" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of arthralgia, mobility decreased.
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Wrong product administered
Clinical narrative: No adverse reactions noted.; patient received both PROQUAD and VARIVAX.; This spontaneous report was received from a healthcare business professional (HBP) concerning a 12-month-old patient of unknown gender. The patient's concurrent condition, medical history, and concomitant medication were not provided.  On 13-NOV-2023, the patient was vaccinated with the single dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin [rHA]) (PNEUMOVAX) injection (lot# X018730, expiry date: 06-JAN-2025; dose, route of administration and anatomical location not provided) and with the single dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot# X017489, expiry date: 25-JUN-2025; dose, route of administration and anatomical location not provided); both as prophylaxis (overdose). No adverse reactions were noted (no adverse event).  This case is one of 3 reports from the same reporter.; Sender's Comments:  US-009507513-2311USA004612: US-009507513-2311USA004439:
Age: 1.0
Sex: U
Vaccine: MMRV, VARCEL, MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reactions noted.; patient received both PROQUAD and VARIVAX.; This spontaneous report was received from a healthcare business professional (HBP) concerning a 12-month-old patient of unknown gender. The patient's concurrent condition, medical history, and concomitant medication were not provided.  On 13-NOV-2023, the patient was vaccinated with the single dose of measles, mumps, rubella and varicella (Oka-Merck) virus vaccine live (recombinant human albumin [rHA]) (PNEUMOVAX) injection (lot# X018730, expiry date: 06-JAN-2025; dose, route of administration and anatomical location not provided) and with the single dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot# X017489, expiry date: 25-JUN-2025; dose, route of administration and anatomical location not provided); both as prophylaxis (overdose). No adverse reactions were noted (no adverse event).  This case is one of 3 reports from the same reporter.; Sender's Comments:  US-009507513-2311USA004612: US-009507513-2311USA004439:
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Injection site discolouration, Injection site induration, Injection site inflammation, Injection site swelling
Clinical narrative: Slight bleeding, swelling - grape sized lump soarness Oral BENEDRYL 25mg, w/i one hr. 11/16/23 - 7:a.m. swelling much reduced now bruised and sore.
Age: 74.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Contusion, Haemorrhage, Mass, Pain, Swelling
Clinical narrative: Slight bleeding, swelling - grape sized lump soarness Oral BENEDRYL 25mg, w/i one hr. 11/16/23 - 7:a.m. swelling much reduced now bruised and sore.
Sex: M
Vaccine: HEPA, MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: vaccines administered after temperature excursion that occurred on 8/1/2023.  Vaccines were administered to unknown patients on unknown dates. No additional AEs; vaccines administered after temperature excursion that occurred on 8/1/2023.  Vaccines were administered to unknown patients on unknown dates. No additional AEs; This spontaneous report was received from a registered nurse referring to an unspecified number of unknown patients. The patients' medical history, concurrent conditions and concomitant therapies were not reported.  On unknown dates, an unspecified number of unknown patients were vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) with lot#W030849, expiry date: 26-MAR-2024 and lot#; X004371, expiry date: 07-AUG-2024 (recombinant Human albumin (rHA)) and varicella virus vaccine live (Oka/Merck) (VARIVAX) lot#W018829, expiry date: 14-JUN-2024 as prophylaxis (dose and route of administration for both vaccines were not provided) that were exposed to temperature excursion of -11.8 Celsius degree, for 29 minutes that occurred on 01-AUG-2023. There were no previous temperature excursions. No additional Adverse events reported.  This is a non-valid case due to lack of patient's identifiers.  Follow-up information was received from the registered nurse regarding the 4 year old male patient.  The patient historical vaccines included varicella virus vaccine live (VARIVAX). Concomitant therapies include fluoride tablets.   On 15-AUG-2023, the patient was vaccinated with the second dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (administered subcutaneously in the right upper arm, lot number W030849, expiration date 06-MAR-2024) and with hepatitis A Vaccine, Inactivated (VAQTA) (administered intramuscularly at the right deltoid, lot number W028555, expiration date 17-JUL-2024). Both vaccines experienced temperature excursion.    Furthermore, the nurse reported that there were ongoing issues with the freezer and auto-defrost. on 01-AUG-2023, the temperatures on state supplied data blogger reached -11.8 degree Celsius for 29 minutes.  She was unaware of temperature excursion until temporarily moving the vaccines to another office for temporary storage to manually defrost and had unit serviced on 16-AUG-2023.  The patient received immunization impacted by excursion prior to notification.  There were no known adverse events.   This case was previously considered non-valid, but upon receipt of follow-up patient identifiers were received and it was determined that the case is now valid.  This is one of three cases from the same reporter (2311USA005370 and 2311USA005371).
Sex: U
Vaccine: MMR, UNK
Symptoms: Product storage error
Clinical narrative: No addtional AE, no report of symptoms or medical concerns; Sterile diluent vial that was frozen; Nurse calling to report adverse event regarding a patient who was administered a dose of MMR II using a STERILE DILUENT vial that was frozen and then thawed prior to use.  Nurse stated that the STERILE DILUENT was transported inappropriately in a fro; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.   On 24-OCT-2023, the patient was vaccinated with a dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) 0.5 mL (lot # W028735, expiration date: 08-SEP-2024, therapy type stablished as rHA) (route of administration, anatomical location not provided) as prophylaxis; which was reconstituted with sterile diluent vial (lot # W029959, expiration date: 24-APR-2025) that was frozen and then thawed prior to use (product storage error, wrong technique in product usage process). The reporter stated that the sterile diluent was transported inappropriately in a frozen environment to a vaccination event, where this one patient received the vaccine. It was confirmed that there was not reports of symptoms or medical concerns from the patient.