chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 43.0
Sex: M
Vaccine: TD
Symptoms: Incorrect dose administered, Syringe issue
Clinical narrative: Patient was administered a Td vaccine while in the office. Patient jerked and the needle came out and some of the liquid squirted on the patients arm. Unknown how much vaccine he got.
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Chills, Cough, Culture, Dyspnoea, Headache
Clinical narrative: HEADACHES, BAD BODY ACHE, CHILLS, COUGH, SOB
Age: 57.0
Sex: F
Vaccine: COVID19, COVID19, COVID19
Symptoms: Pain
Clinical narrative: HEADACHES, BAD BODY ACHE, CHILLS, COUGH, SOB
Age: 73.0
Sex: M
Vaccine: COVID19-2
Symptoms: Acute respiratory failure, Symptom recurrence
Clinical narrative: ACUTE HYPOXEMIC RESPIRATORY FAILURE 11/15/2022  &   1/19/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 46.0
Sex: F
Vaccine: PNC20
Symptoms: Cellulitis, Injection site inflammation, Injection site swelling
Clinical narrative: SWELLING, INFLAMMATION AT INJECTION SITE WHICH TURNED TO CELLULITIS IN LEFT ARM
Age: 27.0
Sex: F
Vaccine: COVID19-2
Symptoms: Erythema, Pruritus
Clinical narrative: itching, redness on hand
Age: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Pulmonary embolism, Symptom recurrence
Clinical narrative: ACUTE PULMONARY EMBOLISM 12/20/2022  &  1/4/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 37.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Underdose
Clinical narrative: Dose error - 0.25 ML was administered instead of 05 ML - no adverse effects noted. Second dose of 0.25ML was administered the same day per CDC recommendations.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Rash, Scar
Clinical narrative: Pt presented to clinic 6/26/23 to discuss whether or not she should receive her second Shingrix dose with Dr., her PCP.  She explained that after receiving the vaccine on 3/16/23, she woke up with severe arm pain and itching on her neck.  She then broke out with a rash on her neck that lasted for over a week and resulted in noticeable scaring. Based on shared decision making, pt and provider have decided to defer the second dose until further notice, however, would like to know the incidence of this particular adverse event.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chronic obstructive pulmonary disease, Forced expiratory volume decreased, Hypoxia
Clinical narrative: R09.02 HYPOXIA 4/22/2023 COPD STAGE 3 SEVERE (FEV1 30-49%)
Age: 52.0
Sex: F
Vaccine: COVID19-2
Symptoms: Neuropathy peripheral, Obstructive sleep apnoea syndrome, Symptom recurrence
Clinical narrative: OBSTRUCTIVE SLEEP APNEA PERIPHERAL NEUROPATHY 2/6/2023  --  RECURRENCE OF HOSPITALIZATION WITH SAME SYMPTOMS
Age: 0.83
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: COVID-19 mRNA LNP-S, bivalent PF 6mos-5yrs (Moderna), 10 mcg/0.2 mL - Wrong dose given (under dosed)
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Swollen tongue, Tongue pruritus
Clinical narrative: Saturday Night my tongue started swelling in the middle and edges of my tongue 5-6 days.  Sunday and Monday started to itch
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Acute respiratory failure, Respiratory failure
Clinical narrative: ACUTE RESPIRATORY FAILURE ACUTE ON CHRONIC HYPOXEMIC RESPIRATORY FAILURE
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: ACUTE STROKE, UNSPECIFIED TYPE AND ARTERY
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered
Clinical narrative: given BUD
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pain, Pyrexia, Swelling
Clinical narrative: Chills, shaking, teeth chattering, fever 102.5, massive body pain and searing pain at site, swollen neck...fever 12 hours later remains at 100.5 with severe body pain
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Chills, shaking, teeth chattering, fever 102.5, massive body pain and searing pain at site, swollen neck...fever 12 hours later remains at 100.5 with severe body pain
Age: 53.0
Sex: F
Vaccine: COVID19
Symptoms: Pigmentation disorder, Pruritus
Clinical narrative: When I had the vaccine it's like having COVID-19 all over again, the pigmentation of my hand and all over my body was changing color, my hand was itching. I called the doctor and send me to a Dermatologist, the person I saw took picture of my hand and sent them to different places, another Dermatologist told me to no scratch it. I had COVID-19 in March 2021 before all the shots.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Fungal infection, Pneumonia, Rash
Clinical narrative: pt called the pharmacy and stated she had a little red dot-like blistery rash all over her arms and her stomach.  She explained she was diagnosed with Valley Fever two years previously which she explained as a fungal infection in the lungs and she was hospitalized.  At that time she had a similar like rash.  She stated Valley Fever was specific to the location where she was living at the time.  She has not had any ongoing issues or symptoms associated with it since that time.   She stated she received the Tdap vaccine a few days ago and was unsure if it was coming from the vaccine since nothing else medication wise changed.  I recommended she inform her primary care physician for further medical advice and I would report the reaction to VAERS
Age: 43.0
Sex: M
Vaccine: TYP
Symptoms: Dry throat, Pharyngeal swelling, Throat irritation
Clinical narrative: Throat began to itch, feel dry and swollen
Age: 0.5
Sex: F
Vaccine: DTPPVHBHPB, DTPPVHBHPB
Symptoms: Erythema, Swelling
Clinical narrative: mom called and reported redness and localized swelling.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test, Pancreatitis, Pulmonary thrombosis
Clinical narrative: Blood clots in lungs and pancreatitis
Age: 75.0
Sex: F
Vaccine: COVID19-2
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: patient has pinkish?colored erythematous patch a little below where she stated the vaccine was given and was warm to touch.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Type 2 diabetes mellitus
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 4/28/2023 DM 2 WO COMPLICATIONS I21.9 ACUTE MI 4/28/2023 DM 2 WO COMPLICATIONS
Age: 12.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Urticaria
Clinical narrative: MOP described patient "complaining" about arms after vaccine administrations. MOP presented pictures of reaction. Mild urticaria present, no redness or swelling. As of 06/26/2023, MOP reported that symptoms have cleared.
Sex: F
Vaccine: COVID19-2
Symptoms: Underdose
Clinical narrative: COVID-19 mRNA LNP-S, bivalent PF 6mos-5yrs (Moderna), 10 mcg/0.2 mL - wrong dose given- (under dosed)
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Dementia Alzheimer's type, Hypothyroidism, Pneumonia
Clinical narrative: I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/25/2023 HYPOTHYROIDISM I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/25/2023 PNEUMONIA I82.401 ACUTE DVT OF RIGHT LEG, UNSPECIFIED VEIN 4/25/2023 ALZHEIMERS DISEASE, LATE ONSET
Age: 59.0
Sex: F
Vaccine: COVID19
Symptoms: Acute myocardial infarction
Clinical narrative: I21.9 ACUTE MI 3/23/2023 NON-ST ELEVATION MYOCARDIAL INFARCTION
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Anxiety, Death, General physical health deterioration, Mechanical ventilation, Pneumonia
Clinical narrative: The patient had a prolonged hospitalization primarily characterized by his dependence on mechanical ventilation.  He remained dependent on the ventilator for approximately the 1-2/3st of his hospitalization with difficulties centering on current pneumonia and secretion management.  He also had significant anxiety but eventually was able to work with psychiatry medication management and respiratory therapy.  He was liberated from the ventilator but continued to require tracheostomy collar with high-flow oxygen support.  He worked with physical and occupational therapy.  He was seen by the Nutrition Service. His mental status remained intact throughout his hospitalization and his wife was supportive at his bedside He was very clear throughout his hospitalization about his expectations and his knowledge of his prognosis. Work on disposition had begun but he had a recurrent episode of pneumonia and his respiratory status continued to decline.  He did not want to be placed back on the ventilator but was agreeable to noninvasive positive pressure support.  Unfortunately this did not improve his respiratory status and he continued to decline as the expectation of not surviving was cleared him.  He died on June 23rd at 5:58 p.m.
Age: 69.0
Sex: M
Vaccine: COVID19-2
Symptoms: Respiratory disorder
Clinical narrative: The patient had a prolonged hospitalization primarily characterized by his dependence on mechanical ventilation.  He remained dependent on the ventilator for approximately the 1-2/3st of his hospitalization with difficulties centering on current pneumonia and secretion management.  He also had significant anxiety but eventually was able to work with psychiatry medication management and respiratory therapy.  He was liberated from the ventilator but continued to require tracheostomy collar with high-flow oxygen support.  He worked with physical and occupational therapy.  He was seen by the Nutrition Service. His mental status remained intact throughout his hospitalization and his wife was supportive at his bedside He was very clear throughout his hospitalization about his expectations and his knowledge of his prognosis. Work on disposition had begun but he had a recurrent episode of pneumonia and his respiratory status continued to decline.  He did not want to be placed back on the ventilator but was agreeable to noninvasive positive pressure support.  Unfortunately this did not improve his respiratory status and he continued to decline as the expectation of not surviving was cleared him.  He died on June 23rd at 5:58 p.m.
Age: 18.0
Sex: M
Vaccine: HEP
Symptoms: Cough, Headache, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Per employee's report , on 6/21/23 employee awoke with body aches and later in day developed headache and fever (100.0 F), and mild cough.  Treatments included Excedrin (acetaminophen, aspirin, and caffeine), Advil (ibuprofen), sleep, and "lots of water" with only body aches lessening  with next 2 days (6/23/23) and fever and headache remaining.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Hypersensitivity, Hypertension
Clinical narrative: I82.4Z1 ACUTE DVT OF RIGHT CALF, UNSPECIFIED VEIN 3/30/2023 HTN (HYPERTENSION) T78.40XA ALLERGIC REACTION, INIT 4/17/2023 HTN (HYPERTENSION)
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Acute myocardial infarction, Cardiac failure acute, Cardiac failure congestive, Hypotension, Left ventricular failure
Clinical narrative: I21.4 ACUTE NON ST ELEVATION MI 4/4/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I21.4 ACUTE NON ST ELEVATION MI 4/4/2023 HYPOTENSION DUE TO MEDICATIONS I21.4 ACUTE NON ST ELEVATION MI 4/4/2023 SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Amyloidosis, Cardiac failure acute, Cardiac failure congestive, Hypervolaemia, Hypotension
Clinical narrative: Pfizer vaccine was administered outside of Facility- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------------- I95.9 HYPOTENSION 4/21/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC I95.9 HYPOTENSION 4/21/2023 AMYLOIDOSIS, UNSPECIFIED I95.9 HYPOTENSION 4/21/2023 HYPERVOLEMIA I95.9 HYPOTENSION 4/21/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I95.9 HYPOTENSION 4/21/2023 AMYLOIDOSIS, UNSPECIFIED
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Left ventricular failure
Clinical narrative: Pfizer vaccine was administered outside of Facility- reported by patient- ? NO LOT NUMBER WERE SUPPLIED ------------------------------------------------------------------------------------------------------------------------------------- I95.9 HYPOTENSION 4/21/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED SYSTOLIC HEART FAILURE, ACUTE ON CHRONIC I95.9 HYPOTENSION 4/21/2023 AMYLOIDOSIS, UNSPECIFIED I95.9 HYPOTENSION 4/21/2023 HYPERVOLEMIA I95.9 HYPOTENSION 4/21/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED I95.9 HYPOTENSION 4/21/2023 AMYLOIDOSIS, UNSPECIFIED
Age: 0.83
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received the Moderna Pink cap when they should have received the Moderna blue cap.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Asthma, Condition aggravated, Epilepsy, Hypoxia, Obstructive sleep apnoea syndrome
Clinical narrative: G40.909 EPILEPSY, UNSPECIFIED 4/22/2023 ASTHMA, UNSPECIFIED W ACUTE EXACERBATION G47.33 ADULT OBSTRUCTIVE SLEEP APNEA, MODERATE 4/22/2023 ASTHMA, UNSPECIFIED W ACUTE EXACERBATION R09.02 HYPOXIA 4/22/2023 ASTHMA, UNSPECIFIED W ACUTE EXACERBATION
Age: 7.0
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect dose administered, Wrong product administered
Clinical narrative: Child was seen at the clinic  For COVID-19  Bi-Valent Pfizer third dose  Vaccine on 06/23/2023 Pfizer Bivalent 12 years and older ( diluted with  1.3 ml   0.9% Sodium Chloride ) 0.2 ML Administered at  Left Deltoid Instead of Pfizer Bivalent  5-11 years ,  which was discovered  during the documentation process . Dr. and Department of health  were  notified.  Provider discussed the Vaccine Issue with the mother  and another appointment made  in 4 weeks.. Child   was observed in the room more than 30 minutes and left the Clinic in stable condition.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Atrial fibrillation, Constipation, Femur fracture, Fracture displacement, Hypoxia
Clinical narrative: R09.02 HYPOXIA 4/29/2023 ATRIAL FIBRILLATION, PAROXYSMAL R09.02 HYPOXIA 4/29/2023 RIGHT FEMUR FX INIT R09.02 HYPOXIA 4/29/2023 RENAL CALCULUS R09.02 HYPOXIA 4/29/2023 RIGHT SUBTROCHANTERIC FEMUR FX, DISPL INIT R09.02 HYPOXIA 4/29/2023 CONSTIPATION
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Nephrolithiasis
Clinical narrative: R09.02 HYPOXIA 4/29/2023 ATRIAL FIBRILLATION, PAROXYSMAL R09.02 HYPOXIA 4/29/2023 RIGHT FEMUR FX INIT R09.02 HYPOXIA 4/29/2023 RENAL CALCULUS R09.02 HYPOXIA 4/29/2023 RIGHT SUBTROCHANTERIC FEMUR FX, DISPL INIT R09.02 HYPOXIA 4/29/2023 CONSTIPATION
Age: 0.5
Sex: F
Vaccine: COVID19-2
Symptoms: Incorrect product formulation administered
Clinical narrative: Patient received the Moderna Pink cap when they should have received the Moderna blue cap.
Age: 47.0
Sex: M
Vaccine: COVID19
Symptoms: Hypersensitivity, Upper gastrointestinal haemorrhage
Clinical narrative: T78.40XA ALLERGIC REACTION, INIT 3/29/2023 UPPER GI HEMORRHAGE
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Cardiac failure congestive, Cardiomyopathy, Hypersensitivity, Hypotension
Clinical narrative: I95.9 HYPOTENSION 4/21/2023 CARDIOMYOPATHY, UNSPECIFIED T78.40XD ALLERGIC REACTION, SUBSEQ 3/21/2023 CARDIOMYOPATHY, UNSPECIFIED I95.9 HYPOTENSION 4/21/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED T78.40XD ALLERGIC REACTION, SUBSEQ 3/21/2023 CHF (CONGESTIVE HEART FAILURE), UNSPECIFIED
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Nausea, Pain in extremity, Vomiting
Clinical narrative: Patient reported fatigue, sore arm, nausea and that he vomited bile once within 24 hours of vaccination
Age: 50.0
Sex: F
Vaccine: MMRV
Symptoms: Wrong product administered
Clinical narrative: patient was given wrong vaccine by mistake, np which ordered vaccine stated it was harmless mistake and the pt will be fine.
Age: 61.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: HCP stated 2 doses of Moderna COVID-19 Vaccine Bivalent were administered after the expiration date; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated 2 doses of Moderna COVID-19 Vaccine Bivalent were administered after the expiration date) and NO ADVERSE EVENT (No adverse event) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 011H22A) for COVID-19 prophylaxis.     Question:Describe relevant medical history/conditions, allergy, concomitant diseases and risk factor.Answer:Unknown.     On 07-Jun-2023, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .5 milliliter. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated 2 doses of Moderna COVID-19 Vaccine Bivalent were administered after the expiration date) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated 2 doses of Moderna COVID-19 Vaccine Bivalent were administered after the expiration date) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown Route), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated 2 doses of Moderna COVID-19 Vaccine Bivalent were administered after the expiration date).    Concomitant medication was not provided. It is unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Date the vial was initially stored in the refrigerator was unknown. The vial did not undergo any temperature excursions Treatment information was not reported.   This case was linked to PR-MODERNATX, INC.-MOD-2023-730068 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jun-2023: Live followup received.; Sender's Comments:  PR-MODERNATX, INC.-MOD-2023-730068:patient 1
Sex: F
Vaccine: HIBV, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: Customer said products may have been administered after a temperature excursion.; No other AE.; This spontaneous report was received from an office manager referring to herself, a female patient of unknown age. The patients' medical history, concurrent conditions, concomitant therapies, previous drug reactions/allergies were not reported.  On unknown dates, the patient was vaccinated with haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) intramuscular injection (strength, dose, lot#, and expiration date were not reported), and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection (strength, dose, route of administration, lot#, and expiration date were not reported) for prophylaxis. The patient said that products might have been administered after a temperature excursion (product storage error). She also said that she did not feel comfortable providing information, and refused to provide any further information. No other adverse event (AE) or product quality complaint (PQC) were provided.
Age: 31.0
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no additional AE; VARIVAX was administered to a patient after it experienced a TE.; This spontaneous report has been received from a pharmacy manager referring to a 31-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, and drug reactions or allergies were not reported. Concomitant mediations included sterile diluent (manufacture unknown).  On 19-APR-2023, the patient was vaccinated with the varicella virus vaccine live (oka/merck) (VARIVAX) injection (0.5 milliliter (mL), lot# W031811, expiration date 05-OCT-2024, strength, route and anatomical location were unknown) for prophylaxis after it experienced a temperature excursion (TE) (product storage error). It was reported that the suspect vaccine was underwent temperature excursions at 46 degree Fahrenheit (F) for 168 hours. There were no previous temperature excursions. No additional adverse event (AE) was provided (no adverse event).  This is one of the two reports received from the same reporter.
Age: 25.0
Sex: U
Vaccine: PNC15
Symptoms: Expired product administered, No adverse event
Clinical narrative: No symptoms or side effects reported by the patient; Medical Assistant called to report that a Patient received an expired dose of VAXNEUVANCE yesterday, 6/14/2023. HCP denies known temperature excursions on product. No symptoms or side effects reported by the patient. Operator of the device is a healt; This spontaneous report was received from a medical assistant referring to a 25-year-old patient. The patient's historical medications, medical history, concurrent conditions and concomitant medications were not reported.      On 14-JUN-2023, the patient was vaccinated with pneumococcal 15v conj vaccine (crm197)(VAXNEUVANCE) lot number U036156, expiration date 23-MAY-2023, 0.5 milliliter (route of administration) for prophylaxis (expired product administered). No adverse event was reported.  The vaccine did not underwent any temperature excursion.
Age: 1.33
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; HCP administered VAQTA to a patient that was improperly stored overnight in the refrigerator. Vaccine had been activated the previous day and was stored with a needle attached and administered the next day; This spontaneous report has been received from a medical assistant referring to a 16-month-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant mediations and drug reactions or allergies were not reported.   On 15-JUN-2023, hepatitis a vaccine, inactivated (VAQTA) had been activated and was stored with a needle attached.  On 16-JUN-2023, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA) intramuscular injection (0.5 milliliter (mL), strength, lot#, expiration date, route and anatomical were not reported) for prophylaxis, which was improperly stored overnight in the refrigerator (product storage error). No additional information was provided. No additional adverse event and no PQC was reported.
Sex: F
Vaccine: HPV4
Symptoms: Hypoaesthesia, Injection site pain, Injection site swelling, Lymphadenopathy, Paraesthesia
Clinical narrative: These included soreness abd swelling at the injection site, swollen lymph nodes in the armpit of that arm that received the injection and tingling/numbness in the hand of the arm that received the injection; These included soreness abd swelling at the injection site, swollen lymph nodes in the armpit of that arm that received the injection and tingling/numbness in the hand of the arm that received the injection; These included soreness abd swelling at the injection site, swollen lymph nodes in the armpit of that arm that received the injection and tingling/numbness in the hand of the arm that received the injection; These included soreness abd swelling at the injection site, swollen lymph nodes in the armpit of that arm that received the injection and tingling/numbness in the hand of the arm that received the injection; These included soreness abd swelling at the injection site, swollen lymph nodes in the armpit of that arm that received the injection and tingling/numbness in the hand of the arm that received the injection; This spontaneous report was received from a merck employee regarding to a female patient of unknown age. No information regarding the patient's medical history, concurrent conditions, previous drug reactions or allergies and concomitant medications was provided.  On 05-JUN-2023, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) intramuscular injection, administered for prophylaxis (strength, lot #, expiry date, and route of administration were not provided).  On an unknown date in June 2023 the patient experienced soreness and swelling at the injections site (vaccination site pain, vaccination site swelling), swollen lymph nodes in the armpit of that arm that received the injection (lymphadenopathy) and tingling, numbness (hypoesthesia, paresthesia) in the hand of the arm that received the injection. At the time of reporting, the outcome of the above events were not provided.  The causal relationship between the aforementioned events and quadrivalent human papillomavirus (types 6,11,16,18) recomb. vaccine (GARDASIL) was not reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; the patient received an improperly stored PROQUAD vaccine; This spontaneous report has been received from a licensed practical nurse referring to a patient of unknown gender or age. The patient's pertinent medical history, concurrent conditions, concomitant mediations and drug reactions or allergies were not reported.   On 15-JUN-2023, the patient was vaccinated with improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (albumin status recombinant human albumin (rHA)) (PROQUAD) injection (product quantity: 1, lot# W039841, expiration date 12-JUN-2024, strength, exact dose, route and anatomical location were unknown) for prophylaxis (product storage error). No additional adverse event was reported.  This is one of the two reports received from the same reporter.; Sender's Comments:  US-009507513-2306USA009052:
Sex: M
Vaccine: HPV9
Symptoms: Computerised tomogram, Groin pain, Scrotal pain, Ultrasound scan
Clinical narrative: Caller reported experiencing scrotum and goin pain; Caller reported experiencing scrotum and goin pain; This spontaneous report was received from a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 16-MAR-2023, the patient started therapy with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, administered intramuscularly (dose, dose number, frequency, vaccination scheme, lot number and expiration date were not provided) for immunization.  On 17-MAR-2023 (reported as the day after vaccination), the patient experienced scrotum and groin pain. The patient asked if these symptoms could be related to the vaccine. No treatment was given. The patient sought medical attention, and an ultrasound and a computerized tomogram were made. At the time of reporting, the patient had not recovered from the events.  The causal relationship between the events scrotal pain and groin pain with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional AE; Inbound call from office manager calling to report administration of VARIVAX that experienced a temperature excursion; This spontaneous report was received from a office manager referring to a patient of unknown age and gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported.      On 21-JUN-2023, the patient was vaccinated with varicella virus vaccine live (oka/merck)(VARIVAX) 0.5 mL once, lot # W039689 with expiration date 13-DEC-2024, for prophylaxis (strength, route of administration and anatomical location were not reported). It was stated that the vaccine experienced previously a temperature excursion with a duration of 52 minutes and a temperature of -13.3°C. No additional adverse event (AE) was reported. A previous temperature excursion was reported. A digital data logger was not involved.; Sender's Comments:  US-009507513-2306USA011426:
Sex: F
Vaccine: PNC15
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Nurse called to report a patient who received a total of 4 doses of VAXNEUVANCE at age 2 months, 4 months, 6 months, and 7 months old; No additional AE; This spontaneous report was received from a nurse and refers to a female patient of unknown age. Patient's pertinent medical history, concurrent conditions, concomitant medications and drug reactions/ allergies were not provided.  On an unknown dates the patient was vaccinated with four doses of pneumococcal 15v conj vaccine (crm197) (VAXNEUVANCE) for prophylaxis (exact dose, route and site of administration, lot# and expiration date were not provided) (inappropriate schedule of product administration and no adverse event).
Sex: U
Vaccine: HEP
Symptoms: Exposure during pregnancy
Clinical narrative: Pregnancy; Initial Report Received 29-Mar-2023  Spontaneous report received from a patient calling the Pregnancy Registry on behalf of a female friend who received HEPLISAV-B for hepatitis B immunization.    Medical history and concomitant medications were not reported.   On an unknown date, one week prior to 29-Mar-2023, the patient reportedly was vaccinated with HEPLISAV-B.  On 28-Mar-2023, the patient found out she was pregnant.    No additional information was reported.    Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Vaccination site pain, Vaccination site swelling
Clinical narrative: Minor pain, redness, and excessive swelling at vaccination site; Minor pain, redness, and excessive swelling at vaccination site; Minor pain, redness, and excessive swelling at vaccination site; This case was retrieved from a download on 01JUN2023.  A 39-year-old male patient developed "minor pain, redness, and excessive swelling at vaccination site" (PT: Vaccination site erythema, PT: Vaccination site pain and PT: Vaccination site swelling) following the administration of BioThrax (anthrax vaccine adsorbed) for immunisation.  On 11MAY2023, the patient received BioThrax (dose: 7plus and lot number: 300209) via intramuscular route in the left arm.  On 12MAY2023, the patient had minor pain, redness, and excessive swelling at the vaccination site.  The outcome of the reported events was unknown at the time of this report.  The action taken with BioThrax with respect to the reported events was not applicable.  The patient's medical history/allergies, current illness, and medications at the time of vaccination were reported as not applicable.  Company comment: A consumer received BioThrax via intramuscular route in the left arm and developed minor pain, redness, and excessive swelling at vaccination site (vaccination site erythema, vaccination site pain and vaccination site swelling). Considering the case information, the causality of vaccination site erythema, vaccination site pain and vaccination site swelling is assessed as possible with BioThrax. The case is considered non serious as per medical assessment.; Sender's Comments: A consumer received BioThrax via intramuscular route in the left arm and developed minor pain, redness, and excessive swelling at vaccination site (vaccination site erythema, vaccination site pain and vaccination site swelling). Considering the case information, the causality of vaccination site erythema, vaccination site pain and vaccination site swelling is assessed as possible with BioThrax. The case is considered non serious as per medical assessment.
Sex: U
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Pain, Rash, Vaccination failure
Clinical narrative: pain; had the shots and still have shingles/ suspected vaccination failure; shingles; blisters; rash; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. In JUN-2023, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: had the shots and still have shingles/ suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: shingles), blister (Verbatim: blisters) and rash (Verbatim: rash). On an unknown date, the patient experienced pain (Verbatim: pain). The outcome of the vaccination failure was unknown and the outcome of the shingles, blister, rash and pain were not resolved.   It was unknown if the reporter considered the vaccination failure, shingles, blister, rash and pain to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, blister, rash and pain to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-JUN-2023 The case was received from the patient via interactive digital media. The reporter stated he/she had both the shots and still had the shingles. It was not itchy but had blisters, rash and pain. It had been about a week and they were not going away very quickly. They were not easy to deal. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain, Vaccination failure
Clinical narrative: had both my Shingles Shots and this is the third time getting it/ Suspected vaccination failure; this is the third time getting it; so painful; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles (had shingles two times).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: had both my Shingles Shots and this is the third time getting it/ Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: this is the third time getting it) and pain (Verbatim: so painful). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 21-Jun-2023 The case was received from the patient via interactive digital media. The patient stated that use Blistex or Carmex (used for cold sores) it relieves pain. The patient had both the shingles shots and this was the third time he or she getting them. The patient stated so painful. This case was considered as suspected vaccination failure since the details regarding the time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Got the shingles shots and suffered about 3 weeks with shingles/ Suspected vaccination failure; Suffered about 3 weeks with shingles anyway; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got the shingles shots and suffered about 3 weeks with shingles/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Suffered about 3 weeks with shingles anyway). The outcome of the vaccination failure was unknown and the outcome of the shingles was resolved (duration 3 weeks).   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 20-JUN-2023 This case was reported by a patient's neighbor via interactive digital media. Reporter stated (Vax-seens) were a joke. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.  The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shingle shot and still got the shingles/Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shingle shot and still got the shingles/Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 22-JUN-2023 The case was received from the patient via interactive digital media. The patient still got the shingles after receiving the Shingle shot. It did a lot of good to him/her. This case was considered as suspected vaccination failure since the details regarding the completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: got the shot and booster and still got the shingles/suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine and Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: got the shot and booster and still got the shingles/suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not reported.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 22-JUN-2023 This case was reported by a patient via interactive digital media. The reporter stated that the shingles vaccine was not full proof. The patient got the shingles shot and booster and still got the shingles. The reporter further stated that more work needed to be done on the shingles vaccine. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The follow up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Herpes zoster, Pruritus, Vaccination failure
Clinical narrative: I had the vaccine (2 shots) almost 2 years ago and came down with shingles 3 weeks ago/ Suspected vacination failure; Shingles; Red patch on my stomach; Itched; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Family history included shingles (patient's sister suffered from shingles).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, more than 2 years after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had the vaccine (2 shots) almost 2 years ago and came down with shingles 3 weeks ago/ Suspected vacination failure) (serious criteria GSK medically significant), shingles (Verbatim: Shingles), skin red (Verbatim: Red patch on my stomach) and pruritus (Verbatim: Itched). The outcome of the vaccination failure was unknown and the outcome of the shingles, skin red and pruritus were not reported.   It was unknown if the reporter considered the vaccination failure, shingles, skin red and pruritus to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles, skin red and pruritus to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 22-JUN-2023 The case was received from the patient interactive digital media. The patient had the vaccine (2 shots) almost 2 years ago and came down with shingles 3 weeks ago of a dollar bill that barely itched.  The patient thanked god his/her sister as she strongly urged him/her to take the vaccine after she suffered from shingles. This case was considered as suspected vaccination failure as details regarding laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the first shot  then when new one came out I got the 2 shots like said to do and I have shingles today/ Suspected vaccination failure; Shingles; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (one dose received on an unknown date).   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: I had the first shot  then when new one came out I got the 2 shots like said to do and I have shingles today/ Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: Shingles). The outcome of the vaccination failure was unknown and the outcome of the shingles was not resolved.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK Receipt Date: 23-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that he or she had the first vaccine and then when new one came out he or she received two doses of Shingles vaccine. The patient stated that he or she have shingles today. This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: The short hurts like hell; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain (Verbatim: The short hurts like hell). The outcome of the pain was not resolved.   It was unknown if the reporter considered the pain to be related to Shingles vaccine.     It was unknown if the company considered the pain to be related to Shingles vaccine.   Additional Information: GSK Receipt date: 20-JUN-2023 This case was reported by patient via interactive digital media. The patient reported that he or she received Shingles vaccine and the shot hurts like hell.  Patient states that he/she had them in his/her hair and down the side of my face, after 4 years I'm still dealing with the side effects Follow up was not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Infection, Pain in extremity
Clinical narrative: arm hurt; Infection; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: arm hurt) and infection (Verbatim: Infection). The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). The outcome of the pain in arm and infection were not reported.   It was unknown if the reporter considered the pain in arm and infection to be related to Shingles vaccine.   It was unknown if the company considered the pain in arm and infection to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 17-JUN-2023 This case was reported by a patient via interactive digital media. The patient got the shingles shot and arm hurt and had to go to doctor to get antibiotics for the infection. The reporter did not think he/she would get the second one now.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm was just a little sore; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included shingles.   In MAY-2023, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced pain in arm (Verbatim: Arm was just a little sore). The outcome of the pain in arm was not reported.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     It was unknown if the company considered the pain in arm to be related to Shingles vaccine.   Additional Information: GSK Receipt Date: 18-JUN-2023 This case was reported by a patient via interactive digital media. The patient reported that she/he had shingles for 3 months very painful. Patient did not have the shot. Patient just got the shingles shot 3 weeks ago before reporting, arm was just a little sore and no problem at all. Patient stated please get the shingles shot it was well worth it. The follow-up could not be possible as no contact details were available.