chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 80.0
Sex: M
Vaccine: FLUA4, RSV
Symptoms: Dyspnoea, Palpitations, Sleep disorder
Clinical narrative: Patient received Vaccines 11/21/23.  "A couple days later" patient woke up in the middle of the night with difficulty breathing and racing heart/palpitations that "looked crazy" on monitor. Patient went to dr for treatment.  Patient will have to have heart ablation performed in february.
Age: 23.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: A small area of redness, mild pain at the injection site, mild headache, and mild fatigue during 12/27/2023 through 12/30/2023. There was no treatment.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Circumstance or information capable of leading to medication error, Injection site injury, Needle issue, Underdose
Clinical narrative: When pharmacist was administering the immunization in the right arm with a 5/8 inch needle, the patient jerked his right arm. The needle bent and we believe no drug was administered. The needle made a 1.5 inch vertical abrasion across the skin surface. We did not readminister.
Age: 71.0
Sex: M
Vaccine: RSV
Symptoms: Atrial fibrillation
Clinical narrative: Patient received the Abrysvo RSV vaccine and devolped A.fib, reporting as it is a risk factor in the studies.
Age: 79.0
Sex: F
Vaccine: COVID19-2, RSV
Symptoms: Feeling hot, Peripheral swelling
Clinical narrative: PT SAYS SHE IS HAVING SWEELING AND WARM FEELING IN HER ARM.   SAYS IT FEELS 'HOT' AND HAS BEEN FOR A FEW DAYS
Age: 84.0
Sex: F
Vaccine: FLUA4, RSV
Symptoms: Injection site bruising
Clinical narrative: PATIENT RETURNED TO PHARMACY 3 DAYS LATER AND PRESENTED WITH BRUISING AT SITE OF INJECTION
Age: 4.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 3 x 2.5" upper L arm Swollen Hard & Red local skin discoloration -ice - do ibuprophen/motrin. circled area 19 min on 10 min off
Age: 82.0
Sex: M
Vaccine: FLUX
Symptoms: Cough, Rhinorrhoea, Secretion discharge, Sputum retention
Clinical narrative: 36 HRS AFTER VACCINATION NOSE RAN FOR 8-10 DAYS. THE A VERY BAD COUGH. FOR ABOUT A WEEK TO 10 DAYS. THEN A VERY THICK MUCUS CAN'T GET RID OF. STILL HAVE AS OF 12-29-23 MUCUS IS SO THICK YOU CAN'T SPIT IT OUT ALMOST CHOKES YOU WHEN YOU TRY TO EXPELL. I HAVE GOT FLU SHOTS FOR MANY YEARS AND HAVE NEVER HAD A PROBLEM WITH THEM. THIS WILL PROBABLY BE MY LAST YEAR TO GET A FLU SHOT.
Age: 17.0
Sex: U
Vaccine: TDAP
Symptoms: Dizziness, Heart rate decreased, Hypotension, Immediate post-injection reaction, Vomiting
Clinical narrative: In summary, a 17 year-old patient was administered a boostrix (tdap) vaccine and had a reaction of lightheadedness, dizziness, and mild vomiting with an onset of less than one minute. I  ensured the patient was sitting down for 10 minutes after since they had not received this vaccine before. Patient had no risk factors for a reaction aside from not receiving any tetanus vaccines in childhood (per patient caregiver). There was no information on their vaccine consent form that would indicate any risk of reaction. The patient was seen and eventually taken by an ambulance that was called with guardian's permission. Patient's life was not in immediate danger, but the ambulance still took her just in case. This was NOT an anaphylactic reaction, and epinephrine was NOT used.
Age: 59.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site pain
Clinical narrative: Pt called the pharmacy on 1/2/2024 to let us know that her arm was still sore at the injection site of her Covid-19 booster. Told pt to contact her PCP.
Age: 0.58
Sex: M
Vaccine: COVID19
Symptoms: Decreased appetite, Diarrhoea, Food aversion, Infant irritability
Clinical narrative: Parent called on 11/18/23 needing advice because patient was fussy and has decreased appetite and loose stool 3 days after getting COVID vaccine - was advised to check for warning signs of dehydration reviewed with parents.  Consider trial Pedialyte, introduce formula and solids as infant desires.  Discussed K+ rich foods.  If decreased wet diapers, emesis or signs of dehydration, fevers CB and may need to consider being seen in ED for IV hydration.  Patient was seen at the clinic on 11/20/23 for diarrhea - He is well-hydrated. His mucus membranes are moist. He has had plenty of wet diapers. His stools seem to be normalizing, though he still has some food aversion. They can give him 3 mL of Tylenol. They can give him children's ibuprofen or Advil. They were advised to keep him drinking fluids. They can offer him different foods. They can give him Pedialyte, formula, cereal, popsicles, or frozen bananas. Discussed ED precautions
Age: 0.75
Sex: M
Vaccine: COVID19
Symptoms: Incorrect dose administered
Clinical narrative: Patient received 0.5 ml dose instead of 0.25 ml.
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Balance disorder, Dizziness, Dizziness postural, Gait disturbance
Clinical narrative: The next evening after the shot I started to feel dizzy.  The next morning I was so dizzy I couldn't get out of bed till noon.  After that once I was up the dizziness was much less as long as I walked gently and moved slowly.  Day 3  improved but if I layed down and got up I was very dizzy. After a week of this I felt better except every morning or through the night if I got out of bed I stumbled and used the walls to keep my balance.  No as of this date I feel recovered.  (hopefully)
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Photophobia
Clinical narrative: Frontal headache, sharp, multiple times daily.  + light sensitivity. Since the day she got the vaccine until today (3 months later).
Age: 44.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: PATIENT CALLED THIS MORNING, STATING SHE CANNOT LIFT HER LEFT ARM, AND IS GETTING A LOT OF PAIN IN THE MUSCLE OF HER UPPER LEFT ARM WHEN SHE TRIES TO LIFT HER ARM.  SHE STATES SHE HAS NEVER EXPERIENCED SUCH A REACTION WITH ANY PRIOR VACCINE.   I ASKED HER IF SHE HAD A PCP, SHE SAID YES, AND I ADVISED HER TO CALL THE PCP OFFICE TO SEEK CARE.
Age: 37.0
Sex: M
Vaccine: RAB
Symptoms: Anxiety, Cold sweat, Feeling of body temperature change, Nausea, Pallor
Clinical narrative: Several months after rabies vaccine series, started having panic attacks, uncontrolled nausea, vomiting, hot/cold sweats, impending feelings of doom, pale skin.
Age: 37.0
Sex: M
Vaccine: RAB
Symptoms: Panic attack, Vomiting
Clinical narrative: Several months after rabies vaccine series, started having panic attacks, uncontrolled nausea, vomiting, hot/cold sweats, impending feelings of doom, pale skin.
Age: 32.0
Sex: M
Vaccine: COVID19-2
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Peripheral coldness
Clinical narrative: Patient returned 30 minutes after vaccination reporting a radiating pain like "hitting his funny bone, but along him arm " at the time of administration. At the time of their return patient reported a sore / numb right wrist and numbness / coldness in his right ring and pinky fingers. Upon inspection there were no visible signs of redness, swelling, or inflammation. Patient was alert and responsive. We recommended alternating ibuprofen and/or tylenol, and gentle heat therapy for the pain as well as messaging the area to promote blood flow.
Age: 71.0
Sex: F
Vaccine: RSV
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: PT REPORTED SWELLING/REDNESS, POSSIBLE CELLULITIS, AND BLISTERS AROUND THE SITE OF INJECTION
Age: 74.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Back pain, Injection site pain, Insomnia, Neck pain
Clinical narrative: 2nd day- pain in arm where injection given,  3rd day pain progressed to shoulder, 4th day pain progressed to neck and upper back . Unable to sleep,Treated with heating pad, tylenol   DID NOT HELP THE PAIN scheduled appt with Dr (My Dr not avail) She prescribed Gabapentin 100 mg capsules 3 X day. Helped the pain a little but was still bad.  December 11th saw my PCP, he gave me a RX for Prednisone 20 mg Tablets ( I took 2 tablets by mouth daily for 3 days) It alleviated my pain and I felt much better but once I finished the RX -2 days later the pain returned.  Dr called in a new RX for Gabapentin 300 mg tablets to take 3 x day.  Pain tolerable not gone. Follow up appt 1/8/24
Age: 5.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Expired product administered, Product storage error
Clinical narrative: The COVID Moderna 2023-2024 vaccine was given after the 30 days window given by the manufacturer when the product is good in the refrigerator.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: COVID Vaccine was given after the 30 day expiration date given by the manufacturer.
Age: 73.0
Sex: F
Vaccine: RSV
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever of 102.5 and arm soreness that started 24 hours after administration
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Computerised tomogram normal, Echocardiogram normal, Full blood count normal, Hypoaesthesia, Magnetic resonance imaging normal
Clinical narrative: Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand,  some feeling of tightness or 'cuffing'.  No muscle weakness or coordination problems, no symptoms in any other part of body or face, mouth or tongue, no change in awareness, vision or speech.  I was able to drive and went home an took one aspirin, then went to the nearby emergency room. The sensations of tingling, numbness, etc. continued for approximately 3-4 hours. I was evaluated for possible TIA and kept in the hospital overnight.   The  Moderna SpikeVax received on 9/23/23 was the 5th COVID vaccine I had received, the previous one on 9/8/22 and all previous vaccines were Pfizer.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Musculoskeletal stiffness, Paraesthesia, Transient ischaemic attack, X-ray normal
Clinical narrative: Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand,  some feeling of tightness or 'cuffing'.  No muscle weakness or coordination problems, no symptoms in any other part of body or face, mouth or tongue, no change in awareness, vision or speech.  I was able to drive and went home an took one aspirin, then went to the nearby emergency room. The sensations of tingling, numbness, etc. continued for approximately 3-4 hours. I was evaluated for possible TIA and kept in the hospital overnight.   The  Moderna SpikeVax received on 9/23/23 was the 5th COVID vaccine I had received, the previous one on 9/8/22 and all previous vaccines were Pfizer.
Age: 65.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Sensory symptoms of eft arm tingling, numbness which started suddenly at around 4 pm from shoulder to hand,  some feeling of tightness or 'cuffing'.  No muscle weakness or coordination problems, no symptoms in any other part of body or face, mouth or tongue, no change in awareness, vision or speech.  I was able to drive and went home an took one aspirin, then went to the nearby emergency room. The sensations of tingling, numbness, etc. continued for approximately 3-4 hours. I was evaluated for possible TIA and kept in the hospital overnight.   The  Moderna SpikeVax received on 9/23/23 was the 5th COVID vaccine I had received, the previous one on 9/8/22 and all previous vaccines were Pfizer.
Age: 51.0
Sex: M
Vaccine: COVID19, COVID19, COVID19
Symptoms: Cough, SARS-CoV-2 test, Throat irritation
Clinical narrative: Scratchy throat, cough
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: CVA the following day after receiving covid and flu vaccines
Age: 1.58
Sex: F
Vaccine: HEPA
Symptoms: Patient uncooperative, Underdose
Clinical narrative: The patient did not have any additional side effects or adverse issues as a result of not receiving the full dose.; A HCP was transferred to this agent from another MTM to report and AE.  The HCP stated that a 19 month old patient received a VAQTA vaccine today (12/28/2023), but she moved and did not get the full dose because the needle came out.  The HCP stated t; This spontaneous report was received from a medical assistant and refers to a 19-month-old female.  The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 28-DEC-2023, the patient started therapy with hepatitis a vaccine, inactivated (VAQTA) intramuscular pre-filled injection, 0.5ml / once, lot #1971512, expiration date: 23-AUG-2024, administered for prophylaxis (strength, and route of administration were not provided), but she moved and did not get the full dose because the needle came out. The health care professional stated that the patient received approximately 1/3 of the recommended dose.  The patient did not have any additional side effects or adverse issues as a result of not receiving the full dose.
Age: 0.58
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No side effects or symptoms; HCP called to report a 7 month old infant received VARIVAX today, 04-DEC-2023.; This spontaneous report was received from a medical assistant and refers to a 7-month-old patient of unknown gender. The patient's concurrent conditions, drug reaction or allergies, pertinent medical history and concomitant therapies were not reported.    On 04-DEC-2023, the patient was vaccinated with a first dose of varicella virus vaccine live (oka/merck) (VARIVAX), 0.5 milliliter, lot # W011622, expiration date 06-APR-2024, for prophylaxis (route was not reported). Varicella virus vaccine live (oka/merck)(VARIVAX) was reconstituted with sterile diluent, lot # W010871, expiration date 17-NOV-2024 (quantity dose was not reported).      The patient received the vaccine earlier than recommended age (product administered to patient of inappropriate age). It was confirmed no side effects or symptoms reported (no adverse event). Also, no additional adverse event and nor product quality complain were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, Extra dose administered, No adverse event
Clinical narrative: No additional AE; HBP also reported HCP inadvertently administered the product again today (12/20/2023), therefore patient received two doses of VARIVAX; expired VARIVAX was administered to a patient post expiration; This spontaneous report was received from an office manager, referring to a patient of unknown age and gender.  The patient's pertinent medical history, concurrent conditions, drug reactions, allergies and concomitant therapies were not reported.  On 18-DEC-2023, the patient was vaccinated with an expired varicella virus vaccine live (oka/merck) (VARIVAX) (expired product administered) injection, at 1 dose, administered for prophylaxis (lot #U039948 which has been confirmed as a valid lot, expiry date was reported and upon internal validation was verified as: 16-DEC-2023, vaccination scheme, anatomical location, strength, and route of administration were not provided). On 20-DEC-2023, the health care provider (HCP) inadvertently administered varicella virus vaccine live (oka/merck) (VARIVAX) (lot #W006412 which has been confirmed as a valid lot, expiry date was reported and upon internal validation was verified as: 23-FEB-2024, anatomical location, strength, and route of administration were not provided) again; therefore, the patient received two doses of suspect vaccine (extra dose administered). No additional adverse event (AE) (no adverse event).
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Product storage error
Clinical narrative: No additional AE to report; Improper storage of product in use; This spontaneous report was received from a physician and refers to a 12 year old female patient. The patient's concurrent conditions, medical history, concomitant medications, drug reactions or allergies were not reported.  On 10-SEP-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # W007025, expiration date: 04-DEC-2024, administered intramuscular (IM) in the left deltoid (LDT) as prophylaxis.  It was reported that at the time of the vaccination, the health care professional did not know that the vaccine was exposed to low temperature excursion (the lowest temperature was -31.7 Fahrenheit on 07-SEP-2023) read from a digital data logger (product storage error). Vaccine for children (VFC) thermometer alarm did not occur. It was stated that after vaccination, no adverse event (AE) was observed; later, on an unspecified date in October 2023, the patient was contacted to find out if any reaction occurred, but any was reported by the patient's mother. The patient was well, and as of December 2023, no AE had been reported.   This is one of three cases reported by the same reporter. ; Sender's Comments:  US-009507513-2310USA011072: US-009507513-2401USA000729:
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE to report; Improper storage of product in use; This spontaneous report was received from a physician and refers to a 12 year old female patient. The patient's concurrent conditions included migraine and chronic idiopathic constipation. No known drug allergies (NKDA) were reported. Her medical history or concomitant medications were not reported.  On 10-SEP-2023, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # W007025, expiration date: 04-DEC-2024, administered intramuscular (IM) in the left deltoid (LDT) as prophylaxis.  It was reported that at the time of the vaccination, the health care professional did not know that the vaccine was exposed to low temperature excursion (the lowest temperature was -31.3 Fahrenheit on 07-SEP-2023) read from a digital data logger (product storage error). Health Authority thermometer alarm did not occur. It was stated that after vaccination, the patient was in the office for 15 minutes, and no adverse event (AE) was observed; later, and up to the reporting time, the patient did not report any adverse reaction to that vaccination.  This is one of three cases reported by the same reporter. ; Sender's Comments:  US-009507513-2310USA011072: US-009507513-2401USA000379:
Age: 67.0
Sex: M
Vaccine: COVID19, RVX
Symptoms: Biopsy, COVID-19, SARS-CoV-2 test
Clinical narrative: Covid fingers, both hands; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Covid fingers, both hands) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. FJ4991, 014M20A and 008B21-2A) for COVID-19 prophylaxis.    Co-suspect product included non-company product RSV VACCINE for an unknown indication.    Concurrent medical conditions included Asthma, Migraine and GERD. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for Asthma, FAMOTIDINE for GERD, VALPROATE SEMISODIUM (DIVALPROEX) for Migraine, INFLUENZA VACCINE (FLU VACCINE VII), TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE), VITAMINS NOS and FISH OIL for an unknown indication.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of RSV VACCINE (unknown route) 1 dosage form. On 28-Sep-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid fingers, both hands). On 05-Mar-2023, COVID-19 (Covid fingers, both hands) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Sep-2022, SARS-CoV-2 test: (Positive) BinaxNOW covid test. On an unknown date, Biopsy: Inconclusive.         Other Moderna covid-19 vaccination details were as follows: patient received first dose on 27-Feb-2021 with 014M20A batch number, second dose on 27-Mar-2021 with batch number 008B21-2A, fourth dose on 18-Oct-2023 with batch number 3030340. Patient was not allergic to medications, food, and other products. The event caused the patient to seek medical care. Patient did not experience similar event in the past. Patient symptom of covid fingers continued months and patient visited with dermatologist. Patient received treatment medication of topical steroids.   This case was linked to MOD-2023-752437 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Dead; This spontaneous case was reported by an other health care professional and describes the occurrence of DEATH (Dead) in a  patient of an unknown age and 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) (Intramuscular use) 1 dosage form. Death occurred on 25-Dec-2023 The patient died on 25-Dec-2023. The cause of death was not reported. An autopsy was performed, but no results were provided.        For mRNA-1273.815 (SPIKEVAX 2023-2024) (Intramuscular use), the reporter did not provide any causality assessments.   It was unknown if the patient experienced any additional symptoms/events. No concomitant and treatment medication were reported.  Company comment:  This fatal spontaneous case concerns a patient (unknown age and unknown gender), with no medical history reported, who received an unspecified dose with Spikevax 2023-2024 vaccine (Andusomeran) and experienced the unexpected, serious (medically significant and death) event of death. Latency cannot be properly assessed since vaccination date was not provided. The cause of death was unknown. As per the report autopsy was performed although the results were not available. No further information regarding the event and cause of death have been provided. The benefit-risk relationship of Spikevax 2023-2024 vaccine (Andusomeran) is not affected by this report.; Reported Cause(s) of Death: Dead
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Overdose
Clinical narrative: I think he was given an overdose of Novavax; IV of Novavax; This serious, initial spontaneous safety report was received by Novavax on 16-DEC-2023 from a consumer via social media monitoring. On 02-JAN-2024, significant additional information was received from a company representative.  A male of an unspecified age and race was vaccinated with intravenous use Nuvaxovid 10 ug/mL suspect Covid-19 vaccine unspecified dose on an unknown date in 2023.  Medical history was reported as Covid-19 (APR-2023).  No concomitant medications were reported.  On an unspecified date in 2023, while hospitalized with Covid, the individual received Novavax intravenously (PT: Incorrect route of product administration) and was on the drip all day. Later on the same day, the individual died. The reporter stated that they think he was given an overdose of Novavax (PT: Overdose) (Serious: Death).  At the time of reporting, the event outcome of Overdose was fatal and Incorrect route of product administration was recovered/resolved.  Lot number was not provided in the report.; Sender's Comments: This male of an unspecified age experienced: Overdose and Incorrect route of product administration after vaccination with Novavax Covid-19 Vaccine, Adjuvanted 10 ug/mL. The event Overdose was reported as serious. The event Incorrect route of product administration was reported as non-serious. Based on the spontaneous nature of the report, the causal relationship between Novavax Covid-19 Vaccine, Adjuvanted and the reported events is considered Possible.; Reported Cause(s) of Death: I think he was given an overdose of Novavax
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Local reaction, Urticaria
Clinical narrative: patient who reacted to DAPTACEL when given at 18 months - had a large localized reaction; Initial information received on 28-Dec-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 18-month-old male patient who reacted to diphtheria-15/tetanus/5 AC pertussis vaccine [Daptacel] when given at 18 months - had a large localized reaction.  The patient's past medical history, medical treatment(s), vaccination(s), concomitant(s) and family history were not provided.  On 27-Oct-2020, the patient received a dose 1 of an unknown dose of suspect diphtheria-15/tetanus/5 AC pertussis vaccine, Suspension for injection (strength, expiry date: unknown) (lot: C5706AA) via intramuscular route in unknown administration site for immunization.  On an unknown date the patient who reacted to daptacel when given at 18 months - had a large localized reaction (skin reaction) (unknown latency) following the administration of diphtheria-15/tetanus/5 AC pertussis vaccine.  Reportedly, They have a 4-year-old patient who reacted to DAPTACEL when given at 18 months - had a large localized reaction and at 4 years old given Kinrix and developed very large hives. Family is requesting an allergy test.  Action taken: was not applicable.  It was not reported if the patient received a corrective treatment for the event.  Outcome: Unknown for the event.
Age: 72.0
Sex: F
Vaccine: COVID19-2
Symptoms: Vitiligo
Clinical narrative: vitiligo - on bilateral arms, legs, and back.  Noticed by patient 2 months after getting covid shot on 10/5/2022.  Has persisted.  no family history of vitiligo.
Sex: F
Vaccine: RSV
Symptoms: Headache
Clinical narrative: Severe headache ongoong; This serious case was reported by a consumer and described the occurrence of headache in a 78-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   Concurrent medical conditions included hypothyroidism and generalized arterial disease. Concomitant products included levothyroxine sodium (Synthroid) and atorvastatin calcium (Lipitor).   On 15-DEC-2023, the patient received Arexvy. On 23-DEC-2023, 8 days after receiving Arexvy, the patient experienced headache (Verbatim: Severe headache ongoong) (serious criteria clinically significant/intervention required). The outcome of the headache was not resolved.   It was unknown if the reporter considered the headache to be related to Arexvy.     It was unknown if the company considered the headache to be related to Arexvy.   Additional Information: RA Receipt date: 28-DEC-2023 The patient self-reported this case. The patient reported that she had severe headache after Arexvy vaccination and was ongoing on reporting day. The reporter requested to consent to follow-up.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; patient received expired VAQTA; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, historical drugs, past drug reactions or allergies, concurrent conditions and concomitant drugs were not reported.   On 28-DEC-2023, the patient was vaccinated with Hepatitis A Vaccine, Inactivated (VAQTA) intramuscular injection (1 dose, lot#: W017819, expiration date: 27-DEC-2023; route of administration and strength were not provided) by health professional for prophylaxis (expired product administered). The administered vaccine had been stored according to prescribing information (PI). No additional adverse events (AE) were reported (no adverse event).
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Brain fog, Fatigue, Feeling cold, Nausea
Clinical narrative: Sore arm, brain fog, tired, chilled, rash, nauseated, no energy
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Sore arm, brain fog, tired, chilled, rash, nauseated, no energy
Age: 40.0
Sex: M
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pharmacist calling to get information on re-vaccination of VARIVAX. Pharmacist stated 40-year-old male received 1st dose of unknown manufacturer of VARICELLA Live vaccine on 2/1/2019. NDC and Lot number is unknown. Only 1 dose was given. Patient did; No additional AE reported; This spontaneous report has been received from a pharmacist and refers to a 40-year-old male patient.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions and concomitant therapies were not reported.  On 02-JAN-2019, the patient was vaccinated with the first dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection, administered for prophylaxis (strength, dosage regimen, vaccination scheme, lot #, expiry date, anatomical site of administration and route of administration were not provided). Only one dose was administered since the patient did not get any other doses (inappropriate schedule of product administration). No additional adverse events were reported.
Age: 11.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine was given
Age: 10.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Expired product administered
Clinical narrative: Patient given expired Covid vaccine
Age: 5.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt given expired covid vaccine
Age: 8.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Expired product administered
Clinical narrative: Pt given expired covid vaccine
Age: 0.5
Sex: U
Vaccine: PNC15, PNC15, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Caller stated patient received 1 dose of ROTATEQ and 1 dose of VAXNEUVANCE after the products were involved in a temperature excursion; This spontaneous report was received from a registered nurse, referring to a 6-month-old patient of unknown gender.  The patient's concomitant medications, pertinent medical history and drug reactions/allergies were not reported.  On 26-DEC-2023, the patient was vaccinated with improperly stored vaccines of rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, lot #1947628, expiration date: 11-JUN-2024 (strength was not provided), 1 dose, administered orally as prophylaxis; and pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) injection (lot #X022028, expiration date: 22-OCT-2025, or lot #X022026, expiration date: 22-OCT-2025 [it was reported that there were 2 lot # of pneumococcal 15v conj vaccine (crm197) [VAXNEUVANCE] and it was unable to confirm which lot number was administered]), 1 dose (strength, and route of administration were not provided), administered as prophylaxis (product storage error). The vaccines were exposed to 13.08 degrees Celsius (C) for 1 hour 15 minutes 0 seconds on an unspecified date. There was no previous temperature excursion. No patient symptoms have been reported. No additional adverse event (AE) was reported (no adverse event).  This is one of several reports received from the same reporter. ; Sender's Comments:  US-009507513-2312USA010597: US-009507513-2312USA010625: US-009507513-2312USA010641: US-009507513-2312USA010648: US-009507513-2312USA010665: US-009507513-2312USA010711: US-009507513-2312USA010768: US-009507513-2312USA010785: US-009507513-2312USA010804: US-009507513-2401USA000001: US-009507513-2401USA000104: US-009507513-2401USA000110: US-009507513-2401USA000120: US-009507513-2401USA000129: US-009507513-2401USA000132: US-009507513-2401USA000138:
Age: 0.17
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; patient received expired PEDVAX HIB; confirmed product had been stored appropriately prior to administration. No additional AE/no PQC.; This spontaneous report was received from a medical assistant concerning to a 2-month-old patient. The patient's concurrent conditions, medical history, concomitant therapies and previous drugs reactions were not provided.    On 29-DEC-2023, the patient was vaccinated with an expired vaccine haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection, 1 dosage form, lot number U026127, with an expiration date of 02-NOV-2023, for prophylaxis (strength, anatomical site of injection, route of administration were not provided)  (expired product administered). No additional adverse event nor product quality complaint.  Lot number U026127 is an invalid lot number for LIQUID PEDVAXHIB.
Sex: U
Vaccine: RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No additional AE/PQC reported.; HCP calling to report patient received an extra dose of ROTATEQ on 28-DEC-2023; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about patient's concomitant medications, concurrent conditions or pertinent medical history.  On 28- DEC-2023, the patient was vaccinated with an extra dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ), orally, lot number 1965643 with expiration date reported as 05-NOV-2024, but upon internal validation established as 05-OCT-2024, (dose was not reported) for prophylaxis (extra dose administered). The patient previously received 3-dose series correctly. No additional adverse events were reported.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE; a dose of vaccine was administered after its labeled expiration date; This spontaneous report was received from a nurse referring to a male patient of unknown age. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.  On 29-DEC-2023, the patient was vaccinated with an expired dose of hepatitis A vaccine, inactivated (VAQTA) intramuscular injection (lot # W023489 has been verified to be a valid lot number for hepatitis A vaccine, inactivated, expiration date was reported as 27-DEC-2023), 1 ml, administered for prophylaxis (concentration and route of administration were not reported) (expired product administered). The vaccine had never undergone temperature excursion. No additional adverse event (AE) was reported.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No PQC/additional AE reported; it was given to an adult patient today, 1 day after expiration; This spontaneous report was received from an Other Health Professional and refers to an adult patient of unknown gender. The patient's medical history, concurrent conditions and concomitant therapies were not provided.  On 28-DEC-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection, expiration date: 27-DEC-2023, administered for prophylaxis (anatomical location, strength, lot #, and route of administration were not provided), and the administration took place one day after expiry date (expired product administered). No additional adverse events (AE) reported.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Inappropriate age at vaccine administration; This spontaneous report has been received from a lawyer, via a Memo, Plaintiff Fact Sheet and Medical Records from a case in litigation for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast) (GARDASIL 9) (2311USA008585), concerning a currently 17-year-old male patient. Details regarding patient's concurrent conditions, concomitant therapies or medical history captured in # 2311USA008585.  On 05-JUL-2006, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) (formulation, dose, route of administration, lot # and expiration date were not reported) for prophylaxis (inappropriate age at vaccine administration). On 07-SEP-2006, she was vaccinated with the second dose of rotavirus vaccine, live, oral, pentavalent (manufacturer unknown) (formulation, dose, route of administration, lot # and expiration date were not reported) for prophylaxis.  This is one of the two reports concerning the same patient.
Sex: F
Vaccine: RSV
Symptoms: Asthenia, Chest pain, Cough, Injection site pain, Injection site pruritus
Clinical narrative: Injection site still itching; Lingering cough/Cough resembling asthma; Skin unusually sore all over; Chest still hurts particularly after mild exertion; weak; achy; Injection site burning; mucosal congestion; sinus intermittent congestion; This non-serious case was reported by a consumer and described the occurrence of injection site itching in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 22-DEC-2023, the patient received Arexvy. In DEC-2023, an unknown time after receiving Arexvy, the patient experienced injection site burning (Verbatim: Injection site burning), nasal congestion (Verbatim: mucosal congestion), sinus congestion (Verbatim: sinus intermittent congestion), skin pain (Verbatim: Skin unusually sore all over), chest pain (Verbatim: Chest still hurts particularly after mild exertion), weakness (Verbatim: weak) and pain (Verbatim: achy). On 22-DEC-2023, the patient experienced cough (Verbatim: Lingering cough/Cough resembling asthma). On 25-DEC-2023, the patient experienced injection site itching (Verbatim: Injection site still itching). The patient was treated with paracetamol (Acetaminophen). The outcome of the injection site itching, injection site burning, cough, chest pain, weakness and pain were not resolved and the outcome of the nasal congestion, sinus congestion and skin pain were not reported.   It was unknown if the reporter considered the injection site itching, injection site burning, nasal congestion, sinus congestion, cough, skin pain, chest pain, weakness and pain to be related to Arexvy.     It was unknown if the company considered the injection site itching, injection site burning, nasal congestion, sinus congestion, cough, skin pain, chest pain, weakness and pain to be related to Arexvy.   Additional Information: GSK Receipt Date- 28-DEC-2023 The patient was a reporter.  The reporter reported that she experienced lingering cough and mucosal congestion, sinus intermittent congestion and mucus. The injection site was still itching and burns. Injection arm did not get sore until late 24 Dec 2023, Itching began 25th Dec 2023 and continued to milder. The reporter stated that she still weak and achy, chest hurts particularly after mild exertion. Skin unusually sore all over. The reporter requested to consent the follow up.
Sex: F
Vaccine: RSV
Symptoms: Mucosal disorder, Nasal congestion, Pain, Pain of skin, Sinus congestion
Clinical narrative: Injection site still itching; Lingering cough/Cough resembling asthma; Skin unusually sore all over; Chest still hurts particularly after mild exertion; weak; achy; Injection site burning; mucosal congestion; sinus intermittent congestion; This non-serious case was reported by a consumer and described the occurrence of injection site itching in a 71-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 22-DEC-2023, the patient received Arexvy. In DEC-2023, an unknown time after receiving Arexvy, the patient experienced injection site burning (Verbatim: Injection site burning), nasal congestion (Verbatim: mucosal congestion), sinus congestion (Verbatim: sinus intermittent congestion), skin pain (Verbatim: Skin unusually sore all over), chest pain (Verbatim: Chest still hurts particularly after mild exertion), weakness (Verbatim: weak) and pain (Verbatim: achy). On 22-DEC-2023, the patient experienced cough (Verbatim: Lingering cough/Cough resembling asthma). On 25-DEC-2023, the patient experienced injection site itching (Verbatim: Injection site still itching). The patient was treated with paracetamol (Acetaminophen). The outcome of the injection site itching, injection site burning, cough, chest pain, weakness and pain were not resolved and the outcome of the nasal congestion, sinus congestion and skin pain were not reported.   It was unknown if the reporter considered the injection site itching, injection site burning, nasal congestion, sinus congestion, cough, skin pain, chest pain, weakness and pain to be related to Arexvy.     It was unknown if the company considered the injection site itching, injection site burning, nasal congestion, sinus congestion, cough, skin pain, chest pain, weakness and pain to be related to Arexvy.   Additional Information: GSK Receipt Date- 28-DEC-2023 The patient was a reporter.  The reporter reported that she experienced lingering cough and mucosal congestion, sinus intermittent congestion and mucus. The injection site was still itching and burns. Injection arm did not get sore until late 24 Dec 2023, Itching began 25th Dec 2023 and continued to milder. The reporter stated that she still weak and achy, chest hurts particularly after mild exertion. Skin unusually sore all over. The reporter requested to consent the follow up.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Fatigue, Heart rate irregular
Clinical narrative: Severe chest pains starting minutes after injection and lasting several hours afterwards, soon after constant fatigue and irregular heartbeat started and has not improved.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt given expired covid vaccine
Age: 7.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Expired product administered
Clinical narrative: Pt given expired covid vaccine
Age: 15.0
Sex: M
Vaccine: COVID19, FLU4
Symptoms: Expired product administered
Clinical narrative: Pt given expired covid vaccine
Age: 16.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt given expired covid vaccine
Age: 17.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Pt given expired covid vaccine.
Age: 17.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given expired covid vaccine
Age: 13.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Expired product administered
Clinical narrative: Patient given expired covid vaccine
Age: 15.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient given expired covid vaccine
Age: 60.0
Sex: M
Vaccine: COVID19, FLU4, VARZOS
Symptoms: Chest discomfort, Dyspnoea, Flushing, Pruritus
Clinical narrative: Patient states that he had trouble breathing with chest tightening and flushing for about 1 minute after initially receiving vaccines. About 5 days after vaccination patient states that he had itching that lasted for a few hours.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site pain, Skin warm, Swelling
Clinical narrative: Patient had headache for 3-4 days after injection. Patient had severe pain at injection site and on day 8 post injection, patient went to a different ED where she received an injection and medrol dosepack for raised redness and warmth.
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Biopsy lymph gland abnormal, Follicular lymphoma stage IV, Lymphadenopathy, Positron emission tomogram abnormal
Clinical narrative: Cervial lymphadenopathy began December 2021. Diagnosed with Stage 4 Follicular Lymphoma 12/14/2023
Age: 34.0
Sex: M
Vaccine: HPV9
Symptoms: Pyrexia
Clinical narrative: Fever up to 102.5F on the night of 1/3, by 1/4 morning it has dropped to 38.3C.
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Diarrhoea, Hyperhidrosis, Migraine, Pain
Clinical narrative: Woke up early am on Jan 4, 2024 vomiting, diarrhea body aches sweats chills migraine in pain all day
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Woke up early am on Jan 4, 2024 vomiting, diarrhea body aches sweats chills migraine in pain all day
Age: 65.0
Sex: F
Vaccine: RSV
Symptoms: Musculoskeletal disorder, Pain, Pain in extremity
Clinical narrative: Patient recieved RSV and arm is really painful described as constant throbbing and cant use the day after
Age: 69.0
Sex: F
Vaccine: COVID19-2
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: I got the covid booster at 12:30pm.  At 2pm afibs started and has been stopping and starting for 2 days.
Age: 10.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given a vaccine that expired 2 days after post thaw expiration date .  Mother informed, opted not to repeat the dose. No adverse event.
Age: 0.33
Sex: M
Vaccine: DTPPVHBHPB, PNC13, RV5
Symptoms: Immediate post-injection reaction, Irritability, Pyrexia
Clinical narrative: Immediately after the vaccine was administered, patient developed a fever of  102 - 103, irritable.  this last about 36 hours.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Brain fog, Dizziness, Fatigue, Pain, Tinnitus
Clinical narrative: Was supposed to be receiving the Novavax vaccine. Confirmed ahead of time over the phone to schedule and repeated again in person. Was not informed the Moderna vaccine was administered instead until receiving post-vaccination paperwork. Severe fatigue, body aches, potential fever (no thermometer to check), brain fog, dizziness. No results yet as I have yet to receive instructions from my doctor. Whilst filling out this form I also began to experience some sort of high-pitched noise others are unable to hear. When I called back to the pharmacy location upon discovering the mix-up (5:40 PM), I spoke to a representative who initially attempted to convince me that the Moderna and the Novavax were the same vaccine (despite different manufacturers, different methods of inoculation (mRNA vs. protein-based) and a variety of important differences). After being put on hold a few times, they agreed that they had given me the Moderna vaccination and that I would be able to return for the second half of the vaccination schedule later. It then occurred to me that not only had they not given me the booster, they had mixed up the vaccinations entirely. After I hung up, I contacted my primary care doctor through her online portal and am waiting on further instructions from a trustworthy health practitioner.
Age: 25.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Was supposed to be receiving the Novavax vaccine. Confirmed ahead of time over the phone to schedule and repeated again in person. Was not informed the Moderna vaccine was administered instead until receiving post-vaccination paperwork. Severe fatigue, body aches, potential fever (no thermometer to check), brain fog, dizziness. No results yet as I have yet to receive instructions from my doctor. Whilst filling out this form I also began to experience some sort of high-pitched noise others are unable to hear. When I called back to the pharmacy location upon discovering the mix-up (5:40 PM), I spoke to a representative who initially attempted to convince me that the Moderna and the Novavax were the same vaccine (despite different manufacturers, different methods of inoculation (mRNA vs. protein-based) and a variety of important differences). After being put on hold a few times, they agreed that they had given me the Moderna vaccination and that I would be able to return for the second half of the vaccination schedule later. It then occurred to me that not only had they not given me the booster, they had mixed up the vaccinations entirely. After I hung up, I contacted my primary care doctor through her online portal and am waiting on further instructions from a trustworthy health practitioner.
Age: 8.0
Sex: F
Vaccine: COVID19, FLU4
Symptoms: Expired product administered, No adverse event
Clinical narrative: Covid vaccine expired 2 days prior to administration per post-thaw expiration date 12/31/23.  Mother informed and opted to not repeat the dose.  No adverse event.
Age: 2.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient was given a vaccine that expired 2 days before administration per post thaw expiration date. Mother informed and opted not to repeat dose. No adverse events
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Headache, Lethargy, Pain
Clinical narrative: Intense headache starting around 4:00pm through evening and lessened slightly durring sleeping time till 8:00am.  Mild headache next day till around noon.  Felt lethargic and slight body aches next day also