chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; 1 Patient was administered improperly stored GARDASIL 9; This spontaneous report was received from a registered nurse, concerning to a 18 year old patient of unknown gender. The patient's historical conditions, concurrent condition, and drug reactions/ allergies were not reported.  On 09-MAY-2019, the patient was vaccinated with improperly stored of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, anatomical location or route of administration were not provided) as prophylaxis; the nurse was unsure which lots had been administered if lot number R020948 with expiration date 04-MAY-2021 or lot number R004689 with expiration date 29-NOV-2020. No adverse effects reported.          The storage temperature of the vaccine was reported as total time and highest temperature above 9 degrees Celsius (°C) (9.3 C, multiple excursions) for 1 hour and 45 minutes. There were no previous temperature excursions. The digital data logger was involved.  This is one of several reports received from the same reporter.  Lot number and expiration date were reported in the source document. But, when entering the lot number in MARRS the system automatically auto-populated the correct expiration date, which sometimes may differs from the expiration date reported by the source.; Sender's Comments:  US-009507513-1906USA000495: US-009507513-1906USA000496: US-009507513-1906USA000487:
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of product administration, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse effects reported; an unknown patient was administered the 3rd dose of ROTATEQ in the series after the recommended 8 months on 05/28/2019; an unknown patient was administered the 3rd dose of ROTATEQ in the series after the recommended 8 months on 05/28/2019; This spontaneous report was received from a medical assistant via a company representative concerning to an infant patient of 8 months old of an unknown race and gender. The patient's pertinent medical history, concurrent conditions, drug allergies or reactions, historical and concomitant drugs were not reported.  On 28-MAY-2019, after the recommended 8 months, the patient received the third dose of the Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) series (inappropriate schedule of vaccine administered, and product administered to patient of inappropriate age), orally for prophylaxis (strength, lot number and expiration date were not reported).  No adverse effects were reported.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination, No adverse event
Clinical narrative: she has not received the third dose; No adverse symptoms reported; This spontaneous report was received from a healthcare professional via company representative referring to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) (strength, formulation, dose/frequency, lot#, expiry date, route were unknown) for prophylaxis. On an unknown date, the patient received 2 doses of quadrivalent human papillomavirus (types 6,11,16,18) recomb. Vaccine (GARDASIL) many years ago and she has not received the third dose (inappropriate schedule of product administration) and no adverse symptoms reported (no adverse event). The outcome of inappropriate schedule of product administration and no adverse event was unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect reported; 1 patient received expired but properly stored VARIVAX; This spontaneous report was received from a medical assistant regarding a patient of 34 years old of unknown gender. The patient's concurrent conditions, pertinent medical history, drug reactions, allergies and concomitant therapies were not reported.  On 03-JUN-2019, the patient was vaccinated with expired but properly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (expired product administered) lot number N014371, expiration date 09-MAY-2019 for prophylaxis (dosage and route of administration was not provided). The varicella virus vaccine live (Oka/Merck) (VARIVAX) was reconstituted with properly stored sterile diluent. No adverse effect reported.
Age: 51.0
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness, Influenza like illness, Nausea, Pain
Clinical narrative: flu like symptoms; light headed; achy; nausea; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 51-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd April 2019, the patient received the 1st dose of Shingrix. On 23rd April 2019, 1 days after receiving Shingrix, the patient experienced influenza-like symptoms, light headedness, pain and nausea. On an unknown date, the outcome of the influenza-like symptoms, light headedness, pain and nausea were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms, light headedness, pain and nausea to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife. The age at vaccination was not reported. At about 5 PM, the patient received Shingrix. Next day of vaccination, the patient had flu like symptoms, nausea, light headed and very achy they lasted for several days with improving gradually. This case was linked with US2019AMR083761, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis, Guillain-Barre syndrome, Intensive care
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of guillain barre syndrome in a 68-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of malaise (received 1st dose and experienced muscle soreness, refer case US2019GSK100301). On an unknown date, the patient received the 2nd dose of SHINGRIX .5 ml. On an unknown date, unknown after receiving SHINGRIX, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant) and dermatitis (serious criteria hospitalization). On an unknown date, the outcome of the guillain barre syndrome and dermatitis were unknown. It was unknown if the reporter considered the guillain barre syndrome and dermatitis to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported, but the patient was 68 years old at the time of reporting. The patient experienced severe dermatitis, possible Guillain barre syndrome (GBS). The patient was in Intensive Care Unit (ICU) for 3 days and was hospitalized for 10 days. The reporter agreed for the follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Myalgia
Clinical narrative: muscle soreness; feeling ill; This case was reported by a physician via sales rep and described the occurrence of muscle soreness in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, unknown after receiving Shingrix, the patient experienced muscle soreness and feeling unwell. On an unknown date, the outcome of the muscle soreness and feeling unwell were unknown.   It was unknown if the reporter considered the muscle soreness and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported, but the patient was 68 years old at the time of reporting. The patient felt ill and had muscle soreness. The reporter agreed for the follow up. For tolerance of 2nd dose of Shingrix refer case US2019AMR097813.
Sex: U
Vaccine: RVX
Symptoms: Bronchiolitis
Clinical narrative: This case was reported in a literature article and described the occurrence of bronchiolitis in a infant subject who received Rotavirus vaccine for prophylaxis. Concurrent medical conditions included digeorge's syndrome (severe combined immunodeficiency disease). On an unknown date, unknown after receiving Rotavirus vaccine, the subject developed bronchiolitis. Serious criteria included hospitalization and GSK medically significant. The outcome of bronchiolitis was unknown. The investigator considered that there was a reasonable possibility that the bronchiolitis may have been caused by Rotavirus vaccine. Additional information was provided. This case was reported in a literature article and described the occurrence of bronchiolitis in an infant of unspecified age and gender who was vaccinated with unspecified rotavirus vaccine (manufacturer unknown) for prophylaxis. This case corresponds to table 1 reported in this literature article. The patient was part of the study that characterize adverse events (AE) after rotavirus (RV) in infants with immunocompromising conditions (IC) reported to the Vaccine Adverse Event Reporting System (VAERS) from February 2006 to December 2015. The patient had DiGeorge syndrome. No information on patient's medical or family history or concomitant medication were provided. On an unspecified date, the patient received unspecified rotavirus virus vaccine (administration route and site unspecified, dosage unknown; batch number not provided). The age of vaccination was not provided. On an unspecified date, an unknown period after vaccination, the patient developed bronchiolitis and subsequently, hospitalised. This case has been considered as serious due to hospitalisation. The treatment was unknown. The outcome of the event was not provided. The author stated and concluded, "Adverse event (AE) after RV in immunocompromised infants are rarely reported to VAERS, but most are clinically serious events. Additional data would be helpful in assessing the safety of RV in non-SCID IC including in-utero exposure to monoclonal antibodies MAB" This is 1 of the 11 valid cases reported in this literature article. The article corresponding to this case is not available for submission due to copyright restriction.
Sex: F
Vaccine: VARZOS
Symptoms: Genital herpes
Clinical narrative: Genital Herpes Flare; This case was reported by a other health professional via call center representative and described the occurrence of genital herpes in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several hours after receiving Shingrix, the patient experienced genital herpes. On an unknown date, the outcome of the genital herpes was unknown.   It was unknown if the reporter considered the genital herpes to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient reported a worsening of her Herpes flare symptoms a few months after receiving the 1st dose of Shingrix. The therapist stated she did not reside in the US and declined to provide any data.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Blood test normal, Computerised tomogram normal, Decreased appetite, Endoscopy normal
Clinical narrative: 9 pound weight loss; loss of appetite; loss of energy; can not stand odors; nausea; This case was reported by a consumer via call center representative and described the occurrence of weight loss in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th April 2019, 10 days after receiving Shingrix, the patient experienced nausea, loss of energy and hyperosmia. On 18th April 2019, the patient experienced appetite lost. On an unknown date, the patient experienced weight loss. The patient was treated with ondansetron. On 14th May 2019, the outcome of the appetite lost was recovered/resolved. On an unknown date, the outcome of the weight loss, nausea and loss of energy were not recovered/not resolved and the outcome of the hyperosmia was recovered/resolved.   The reporter considered the weight loss, nausea, appetite lost, loss of energy and hyperosmia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The consumer stated that she received Shingrix and 10 days later developed nausea, loss of energy, and could not stand odors.  On 18th April 2019, 17 days after receiving a dose of shingrix,she lost her appetite. On 23rd April 2019, the patient went to Urgent Care. On 2nd May 2019, the patient visited the physician (MD). On an unknown date, unknown after receiving a dose of shingrix, she lost 9 lbs. The reporter stated that she had a head to stomach computed tomography (CT), endoscopy, gall bladder scan, and numerous blood tests, all results were within normal limits.  She stated that the MDs ruled out everything except for a reaction to the Shingrix vaccine.  The reporter stated that she was treated with two anit-nausea medications. The nausea and lack of energy persist. The loss of appetite resolved and the not being able to stand odor resolved. The reporter consented to follow up. Emergency room visit required. The consumer did not have the vaccine information for this adverse event.      Lab Comments: on unknown date patient had a head to stomach CT, endoscopy, gall bladder scan, and numerous blood tests, all results within normal limits
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Hepatobiliary scan normal, Nausea, Parosmia, Weight decreased
Clinical narrative: 9 pound weight loss; loss of appetite; loss of energy; can not stand odors; nausea; This case was reported by a consumer via call center representative and described the occurrence of weight loss in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 11th April 2019, 10 days after receiving Shingrix, the patient experienced nausea, loss of energy and hyperosmia. On 18th April 2019, the patient experienced appetite lost. On an unknown date, the patient experienced weight loss. The patient was treated with ondansetron. On 14th May 2019, the outcome of the appetite lost was recovered/resolved. On an unknown date, the outcome of the weight loss, nausea and loss of energy were not recovered/not resolved and the outcome of the hyperosmia was recovered/resolved.   The reporter considered the weight loss, nausea, appetite lost, loss of energy and hyperosmia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The consumer stated that she received Shingrix and 10 days later developed nausea, loss of energy, and could not stand odors.  On 18th April 2019, 17 days after receiving a dose of shingrix,she lost her appetite. On 23rd April 2019, the patient went to Urgent Care. On 2nd May 2019, the patient visited the physician (MD). On an unknown date, unknown after receiving a dose of shingrix, she lost 9 lbs. The reporter stated that she had a head to stomach computed tomography (CT), endoscopy, gall bladder scan, and numerous blood tests, all results were within normal limits.  She stated that the MDs ruled out everything except for a reaction to the Shingrix vaccine.  The reporter stated that she was treated with two anit-nausea medications. The nausea and lack of energy persist. The loss of appetite resolved and the not being able to stand odor resolved. The reporter consented to follow up. Emergency room visit required. The consumer did not have the vaccine information for this adverse event.      Lab Comments: on unknown date patient had a head to stomach CT, endoscopy, gall bladder scan, and numerous blood tests, all results within normal limits
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Activated partial thromboplastin time normal, Computerised tomogram head normal, Diarrhoea, Facial paralysis, Full blood count normal
Clinical narrative: Patient reported swelling and pain at injection site and then developed nausea, vomiting, diarrhea, and headache 24 - 48 hours after injection. Began to feel better and then 4 days after vaccine reported swelling of left side of lips with mild facial droop and numbness left side of face.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Injection site pain, Injection site swelling, Lip swelling
Clinical narrative: Patient reported swelling and pain at injection site and then developed nausea, vomiting, diarrhea, and headache 24 - 48 hours after injection. Began to feel better and then 4 days after vaccine reported swelling of left side of lips with mild facial droop and numbness left side of face.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Metabolic function test normal, Nausea, Prothrombin time normal, Troponin normal, Vomiting
Clinical narrative: Patient reported swelling and pain at injection site and then developed nausea, vomiting, diarrhea, and headache 24 - 48 hours after injection. Began to feel better and then 4 days after vaccine reported swelling of left side of lips with mild facial droop and numbness left side of face.
Age: 1.67
Sex: F
Vaccine: MMR
Symptoms: Decreased appetite, Pyrexia, Rash
Clinical narrative: High Fever, irritable, loss of appetite, rash on trunk
Age: 0.58
Sex: M
Vaccine: DTAPHEPBIP, HIBV, RV5, UNK
Symptoms: Extensive swelling of vaccinated limb, Immunology test, Pyrexia, Skin discolouration, Ultrasound scan
Clinical narrative: Increased fever, not relieved with tylenol or motrin. Excessive swelling with discoloration in right leg and arms. Private MD notified and several days later client referred to ER.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Axillary mass, Axillary pain
Clinical narrative: Swelling underarm in arm pit painful Started the morning after injection. Continued to worsen over next five days contacted dr office today-(day 5) they said take ibuprofen 600mg 3x and recontact tomorrow.
Age: 4.0
Sex: F
Vaccine: DTAP, IPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Observed 1-1-08 round, red, swollen area on right arm (12-26-2007, MMRV. RA) (Polio and DTaP LA) tender and warm for a little while, itchy.  S/S appear to be within normal limits.
Age: 14.0
Sex: M
Vaccine: MMR
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Autonomic nervous system imbalance, Blood alkaline phosphatase increased, Blood immunoglobulin M increased
Clinical narrative: within 2 weeks of vaccination, red bump developed...continued to grow/raise. Now, TEN months later, there is a 11x8 millimeter round raised bump - appears to be scar tissue (thick).  A few months following vaccination, he was seen by both a naturopath and opthamologist.  Both agreed something odd was going on - specifically impacting his autonomic nervous system - trouble focusing his eyes after reading - taking up to 1 min to come into focus, heart rate randomly racing and blood work showed liver enzymes were outside of normal ranges.
Age: 14.0
Sex: M
Vaccine: MMR
Symptoms: Cytogenetic analysis abnormal, Cytomegalovirus test positive, Erythema, Mass, Methylenetetrahydrofolate reductase gene mutation
Clinical narrative: within 2 weeks of vaccination, red bump developed...continued to grow/raise. Now, TEN months later, there is a 11x8 millimeter round raised bump - appears to be scar tissue (thick).  A few months following vaccination, he was seen by both a naturopath and opthamologist.  Both agreed something odd was going on - specifically impacting his autonomic nervous system - trouble focusing his eyes after reading - taking up to 1 min to come into focus, heart rate randomly racing and blood work showed liver enzymes were outside of normal ranges.
Age: 14.0
Sex: M
Vaccine: MMR
Symptoms: Palpitations, Scar, Tri-iodothyronine increased, Vision blurred
Clinical narrative: within 2 weeks of vaccination, red bump developed...continued to grow/raise. Now, TEN months later, there is a 11x8 millimeter round raised bump - appears to be scar tissue (thick).  A few months following vaccination, he was seen by both a naturopath and opthamologist.  Both agreed something odd was going on - specifically impacting his autonomic nervous system - trouble focusing his eyes after reading - taking up to 1 min to come into focus, heart rate randomly racing and blood work showed liver enzymes were outside of normal ranges.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, RV5, UNK
Symptoms: Blister, Rash, Rash erythematous
Clinical narrative: Rash started yesterday 1/8/2008 at 4 pm, and spread to arms, legs and trunk. Red blisters which subsided to raised red rash. On 1/9/2008, seen in the clinic and the rash is less swollen and better per mother. No fever, motrin 1.25ml given PO at 1/8/2008, 2100.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site pruritus, Nausea
Clinical narrative: Fever; very weak; body pain all over ; nausea  ;  left upper arm very red , pain and itchy.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever; very weak; body pain all over ; nausea  ;  left upper arm very red , pain and itchy.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Pyrexia
Clinical narrative: FEVER A FEW HOURS AFTER INJECTIONS. MOTHER STATES THAT IT WAS 101.9.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Extreme muscle pain in arm - could not sleep because of pain for 3 days,   Extremely tired 4 days at injection sight about a 5 inch circle swelling, rash, itching. pain still today 6 days after shot couldn't do regular routine for 4 days
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia
Clinical narrative: Extreme muscle pain in arm - could not sleep because of pain for 3 days,   Extremely tired 4 days at injection sight about a 5 inch circle swelling, rash, itching. pain still today 6 days after shot couldn't do regular routine for 4 days
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Cold sweat, Dizziness, Nausea
Clinical narrative: Approximately 20 hours after vaccination, patient had an extreme dizzy spell at work along with cold sweats and nausea.
Age: 62.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Myalgia
Clinical narrative: patient called pharmacy stating that since receiving the vaccination she has been experiencing joint pain and muscle aches
Age: 22.0
Sex: F
Vaccine: HEP
Symptoms: Balance disorder, Dizziness
Clinical narrative: At 2:10 PM donor felt like, "head felt dizzy, legs felt like jello, and lightheaded." At  2:35 PM  Bp 98/68 pulse 68.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh swelling and warm to the touch at the injection site. Afebrile,playing without difficulty, treating with tylenol and benadryl. Seen i office on 05/30/2019 size of redness was noted as 5x4 inches area traced for follow up. Talked with mother on 05/31 and noted to be slightly less swollen. advised follow up if area changes or worsens
Sex: F
Vaccine: HPVX
Symptoms: Autoimmune disorder
Clinical narrative: This spontaneous report was received from a physician via company representative referring to a female patient of unknown age. The patient's pertinent medical history, drug reactions/allergies and concomitant medications were not reported. Approximately 5 years ago the physician read in the media report that, on an unknown date, the patient was administered with GARDASIL 9 (dose, strength, lot number, expiry date, route of administration were unknown) or GARDASIL (dose, strength, lot number, expiry date, route of administration were unknown) for prophylaxis. On an unknown date, patient experienced an unspecified auto immune symptom or possibly guillain barre syndrome(guillain barre syndrome). Outcome and causality assessment were not provided by the reporter. No product quality complaint was filed by the reporter. Upon internal review, guillain barre syndrome was determined to be medically significant. Company Causality Assessment: Based on the limited information currently available for this case, a reasonable possibility to suggest a relationship between GARDAIL 4 vaccine and/or GARDASIL 9 vaccine and the reported event of Guilllain-Barre syndrome cannot be established. Missing information includes: demographic details of the subject, date of vaccination (for all doses of vaccine), onset of the event, detailed clinical course, diagnostic work up (other causes ruled out), neurologist clinical evaluation and follow up. Company Comment- No changes to GARDASIL 4 vaccine and/or GARDASIL 9 vaccine product safety information are warranted at this time.  Merck and Co., Inc., continues to monitor the safety profile of GARDASIL 4 vaccine and/or GARDASIL 9 vaccine product.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Patient states Redness all the way around bottom of bra line chest area, up on left shoulder where bra strap is, some redness on right shoulder but worse on left shoulder.   patient states area was red and slick feeling, also  warm to touch.
Age: 56.0
Sex: M
Vaccine: HEP
Symptoms: Dyspnoea, Fatigue, Headache, Hyperhidrosis
Clinical narrative: PATIENT C/O TIREDNESS, HEADACHE, DIAPHORIC AND STATED FEELING SHORT OF BREATH
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Dyspnoea, Erythema, Flushing, Nausea, Paraesthesia
Clinical narrative: Patient received Menactra at 1346 PM, per nursing staff patient had left building then returned 30 minutes later with complaint of right hand tingling, shortness of breath, throat itching, hives to right wrist and face. Injection was to left deltoid and no reaction at site.  On exam: patient alert, speaking in full sentences, lungs CTA bilaterally with good air movement, Heart rate regular without murmur Wheal approximately 3 mm noted x 2 to right wrist, cheeks flushed/pink with approximately 3 small wheals noted. Injection site clear.    Patient given Diphenhydramine 50 mg po at 1420; still complaining of shortness of breath, throat itching, nausea. Epi Pen given at 1440. Patient stated her itchy throat and shortness of breath improved, EMS notified and patient transferred to monitor.   1523 patient arrived at ED. Initial SpO2 considered adequate. Upon examination, patient is well-appearing, in no acute distress. Vital signs are stable. 1545 Solu-Medrol 80mg IV given. 1628 Patient re-evaluated and reports feeling improved. Tolerating apple juice. 1650 patient reports nausea and itching increasing. Famotidine 20mg IV and Ondansetron 4mg ODT given. 1900 patient discharged home with return precautions.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Throat irritation, Urticaria
Clinical narrative: Patient received Menactra at 1346 PM, per nursing staff patient had left building then returned 30 minutes later with complaint of right hand tingling, shortness of breath, throat itching, hives to right wrist and face. Injection was to left deltoid and no reaction at site.  On exam: patient alert, speaking in full sentences, lungs CTA bilaterally with good air movement, Heart rate regular without murmur Wheal approximately 3 mm noted x 2 to right wrist, cheeks flushed/pink with approximately 3 small wheals noted. Injection site clear.    Patient given Diphenhydramine 50 mg po at 1420; still complaining of shortness of breath, throat itching, nausea. Epi Pen given at 1440. Patient stated her itchy throat and shortness of breath improved, EMS notified and patient transferred to monitor.   1523 patient arrived at ED. Initial SpO2 considered adequate. Upon examination, patient is well-appearing, in no acute distress. Vital signs are stable. 1545 Solu-Medrol 80mg IV given. 1628 Patient re-evaluated and reports feeling improved. Tolerating apple juice. 1650 patient reports nausea and itching increasing. Famotidine 20mg IV and Ondansetron 4mg ODT given. 1900 patient discharged home with return precautions.
Age: 1.0
Sex: F
Vaccine: HEPA, HIBV, MMR
Symptoms: Injection site mass
Clinical narrative: Lump at injection site
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pruritus, Injection site vesicles
Clinical narrative: patient is saying that her arm is red and has 3 blisters above the injection site and some itching accuring
Age: 62.0
Sex: M
Vaccine: HEPA
Symptoms: Blood glucose normal, Electrocardiogram normal, Hypopnoea, Loss of consciousness, Syncope
Clinical narrative: Patient fainted, was unconscious for 30 to 40 seconds. We called 911. Patient was brought from chair to floor. patient had a pulse and was having shallow breaths. After around thirty seconds patient regained consciousness and became alert. patient correctly responded to questions of date and place.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of product administration, Nodule
Clinical narrative: Patient received Zostavax 11/5/2012.   He said it was given IM, form says it was given SQ.   Patient has a knot in his arm which he showed me on 6/1/19.
Age: 55.0
Sex: M
Vaccine: TDAP
Symptoms: Facial paralysis
Clinical narrative: R sided facial palsy No evidence of shingles and no evidence or hx HSV-1
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Dizziness, Dyspnoea, Neuralgia
Clinical narrative: Pt stated when he was leaving pharmacy he felt a little light headed, so after he developed chest pain and difficulty breathing.  Overnight patient experienced a neurological pain in throughout his back from top to bottom.  The following morning the chest pain continued, and pt began gasping for air, at which point he called 911.  In ER pt received oxygen and morphine, was released after 5 hours with instructions to follow up with cardiologist for stress test.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Syncope
Clinical narrative: Dizziness and fainting spell
Age: 31.0
Sex: M
Vaccine: HEP, MMRV, VARCEL
Symptoms: No adverse event, Product packaging confusion, Wrong product administered
Clinical narrative: no adverse reaction noted - MMRV was inadvertently administered instead of MMR because of how much the boxes look and sound alike.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Malaise
Clinical narrative: Patient presented a swelling of injection site combined with feeling ill.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pain, Pain in extremity, Tenderness
Clinical narrative: Patient is having arm pain over two weeks following the injection. She says it feels like muscle pain. She pointed to it and it is lower on her arm almost to the back of the arm. She says it hurts all the time but more when she moves it and when she touches it.
Age: 81.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, X-ray limb normal
Clinical narrative: Patient is having arm pain over two weeks following the injection. She says it feels like muscle pain. She pointed to it and it is lower on her arm almost to the back of the arm. She says it hurts all the time but more when she moves it and when she touches it.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Heart rate increased, Hyperhidrosis, Loss of consciousness, Pain
Clinical narrative: patient presented to the pharmacy on 6/4 and reported she had a severe reaction to her Shingrix vaccine she was given on 5/16. she described the reaction as severe sweating, fatigue, an increased heart rate, and she even blacked out. she received the vaccine around 10:00am on 5/16 and she reported that these events happened later that day around 7:00pm. she had the first does with only mild reaction (fatigue, soreness), so she was concerned when this happened with the second dose. i asked if she sought any medical attention at the ime of or after the adverse event occured and she said no. she said the next day she felt fine. but she wanted us to know her reaction so it could potentially help other patients in the future who may suffer the same adverse effects after getting the vaccine
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: patient presented to the pharmacy on 6/4 and reported she had a severe reaction to her Shingrix vaccine she was given on 5/16. she described the reaction as severe sweating, fatigue, an increased heart rate, and she even blacked out. she received the vaccine around 10:00am on 5/16 and she reported that these events happened later that day around 7:00pm. she had the first does with only mild reaction (fatigue, soreness), so she was concerned when this happened with the second dose. i asked if she sought any medical attention at the ime of or after the adverse event occured and she said no. she said the next day she felt fine. but she wanted us to know her reaction so it could potentially help other patients in the future who may suffer the same adverse effects after getting the vaccine
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: APPROXIMATELY 8 DAYS AFTER RECEIVING VACCINE RASH DEVELOPED ON CHEST
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Skin burning sensation
Clinical narrative: APPROXIMATELY 8 DAYS AFTER RECEIVING VACCINE RASH DEVELOPED ON CHEST
Age: 66.0
Sex: F
Vaccine: PNC13, TDAP, VARZOS
Symptoms: Injection site inflammation
Clinical narrative: inflammation at site of injection
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal faeces, Diarrhoea, Fatigue, Injection site erythema, Injection site swelling
Clinical narrative: red, swollen left upper are, hot at injection site, stiff arm, total body aches, on evening of shot.  Day 2 same symptoms plus nausea, exhaustion, diarrhea.  Day 3 same as listed, Day 4 arm still warm and swollen at injection site, nausea gone, still not normal bowel movements, and some aches. Day 5 arm still red and minor selling at site.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Nausea, Pain
Clinical narrative: red, swollen left upper are, hot at injection site, stiff arm, total body aches, on evening of shot.  Day 2 same symptoms plus nausea, exhaustion, diarrhea.  Day 3 same as listed, Day 4 arm still warm and swollen at injection site, nausea gone, still not normal bowel movements, and some aches. Day 5 arm still red and minor selling at site.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip swelling
Clinical narrative: reported to emergency room with swollen lips. was given prednisone and Benadryl
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Peripheral swelling
Clinical narrative: Patient states one week after getting vaccine her hands swelled.
Age: 1.75
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Red, swollen area around vaccination site
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: pt talked to store manager on Saturday 06-01-2019 and complained of a red swollen and painful injection site area
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Abscess, Benign neoplasm, Biopsy, Blood test, Computerised tomogram
Clinical narrative: She received her 2nd Series of the HPV shot March of 2017, a few days later she began to complain about pain in her arm and the tenderness it started to turn red I contacted the Doctors office and they advised her to apply a hot suppressant to her arm to move the medicine around after the 2nd visit, the injection site began to get worse we contacted the doctor and they began to treat it with antibiotics until the exhausted the antibiotics they then referred her to a surgeon. On Nov 06 2017 she woke up in severe pain and her arm locked up on her. I rushed her to hospital and after the MRI Dr diagnosed her with a abscess he removed the abscess after the surgery she began to have problems again and ins currently in treatment for what she is now diagnosed as a tumor.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Injection site reaction, Mobility decreased, Nuclear magnetic resonance imaging abnormal, Pain in extremity
Clinical narrative: She received her 2nd Series of the HPV shot March of 2017, a few days later she began to complain about pain in her arm and the tenderness it started to turn red I contacted the Doctors office and they advised her to apply a hot suppressant to her arm to move the medicine around after the 2nd visit, the injection site began to get worse we contacted the doctor and they began to treat it with antibiotics until the exhausted the antibiotics they then referred her to a surgeon. On Nov 06 2017 she woke up in severe pain and her arm locked up on her. I rushed her to hospital and after the MRI Dr diagnosed her with a abscess he removed the abscess after the surgery she began to have problems again and ins currently in treatment for what she is now diagnosed as a tumor.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Positron emission tomogram, Surgery, Tenderness, Ultrasound scan, X-ray
Clinical narrative: She received her 2nd Series of the HPV shot March of 2017, a few days later she began to complain about pain in her arm and the tenderness it started to turn red I contacted the Doctors office and they advised her to apply a hot suppressant to her arm to move the medicine around after the 2nd visit, the injection site began to get worse we contacted the doctor and they began to treat it with antibiotics until the exhausted the antibiotics they then referred her to a surgeon. On Nov 06 2017 she woke up in severe pain and her arm locked up on her. I rushed her to hospital and after the MRI Dr diagnosed her with a abscess he removed the abscess after the surgery she began to have problems again and ins currently in treatment for what she is now diagnosed as a tumor.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Decreased appetite, Extra dose administered, Injection site erythema, Pyrexia, Sleep disorder
Clinical narrative: They have her double dose of Heb B and polio. The next day when she woke up she had a 101.8 fever and it lasted for 3 days and her injections were red! She didn?t eat or sleep good for 3 day also.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Lymphadenopathy, Malaise, Peripheral swelling
Clinical narrative: Patient in to clinic for 2nd shingrex. Patient stated that he had become deathly ill for several days after 1st injection. Patient stated that lymph nodes in right axillary and arm had been swollen, & deathly ill...lymph nodes in R axillary and arm swollen
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Epistaxis, Haemoglobin normal, Platelet count decreased, Prothrombin time prolonged, Pyrexia
Clinical narrative: High Fever (T104F 5/30 after MMR Admin 5/23) that evening 5/31 seen in ED with posterior nose bleed - plts 40K. Sent to tertiary care hosp consulted & admitted by hematology. Sx resolved after steroids. Being followed outpt.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site swelling, Tenderness
Clinical narrative: Redness, swelling below injection site. Chills 2nd day, tender to the touch
Sex: F
Vaccine: DTAPIPV, HEPA, MMRV
Symptoms: Injection site cellulitis, Injection site discharge, Injection site erythema, Injection site scab, Injection site warmth
Clinical narrative: 5/28/19 Immunizations given 5/29/19 Per mom child woke up with red, hot spot on left leg that was hot to touch and approximately 2 inches by 2 inches in diameter. 5/30/19 Per mom redness had gotten larger and opened and was draining yellow fluid and was crusty; size was approximately 4 or 5 inches in the center with about 1 inch open. Child was taken to a provider and diagnosed with cellulitis and placed on antibiotics.  6/4/19 Per mom open area is scabbed over, red size about 2 inches in diameter.
Age: 87.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site warmth, Nausea
Clinical narrative: Bruising, Redness, warm site of injection to touch, Nausea
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: OVERALL REDNESS, SWELLING, HEAT TO TOUCH ON UPPER ARM - FRONT AND PARTIALLY AROUND - SHOULDER TO ELBOW
Age: 59.0
Sex: F
Vaccine: TD
Symptoms: Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Patient reported sx of redness around injection site, arm pain, + fever
Age: 1.42
Sex: M
Vaccine: MMR
Symptoms: Cyanosis, Decreased appetite, Fatigue, Febrile convulsion, Malaise
Clinical narrative: One day after vaccination my baby started to get a fever and had typical ill symptoms such as drowsiness, lack of appetite, fatigue and high temperature. He never went back to full normal until on 6/3/2019, 11 days after the MMR Vaccine he got a febrile seizure! He stopped breathing, turned greyish blue. I called immediately 911, the ambulance came and he got transported via ambulance to the Hospital. He is not himself since. Today is 6/4/2019 and he is still running fevers and i am trying to keep the fever down via suppositories. He rejexts any type of oral fever reducer.
Age: 1.42
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Respiratory arrest, Somnolence
Clinical narrative: One day after vaccination my baby started to get a fever and had typical ill symptoms such as drowsiness, lack of appetite, fatigue and high temperature. He never went back to full normal until on 6/3/2019, 11 days after the MMR Vaccine he got a febrile seizure! He stopped breathing, turned greyish blue. I called immediately 911, the ambulance came and he got transported via ambulance to the Hospital. He is not himself since. Today is 6/4/2019 and he is still running fevers and i am trying to keep the fever down via suppositories. He rejexts any type of oral fever reducer.
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Headache, Hyperhidrosis, Malaise, Muscle discomfort
Clinical narrative: Severe sudden onset headache located in the temporal region of head, states this  lasted short time then was a low grade HA for several days, pt also describes malaise, muscle and joint discomfort,  chills and sweats, and overall feeling of "unwell"
Age: 28.0
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal discomfort
Clinical narrative: Severe sudden onset headache located in the temporal region of head, states this  lasted short time then was a low grade HA for several days, pt also describes malaise, muscle and joint discomfort,  chills and sweats, and overall feeling of "unwell"
Sex: F
Vaccine: HPV9
Symptoms: Malaise, Nasopharyngitis, Oropharyngeal pain, Pyrexia
Clinical narrative: I feel under the weather, like I have a cold with sore throat, cold symptoms and kinda feverish; This spontaneous report has been received from a 43-year-old female patient (also a company representative) concerning herself with seasonal allergy. The patient's medical history included thyroid disorder. Concomitant therapies included escitalopram and levothyroxine sodium (SYNTHROID).     On 15-MAY-2019 (also reported as "yesterday afternoon"), the patient was administrated with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (strength, dose, route, lot # and expiration date were not reported) for vaccine. The first dose of the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series was administrated 2 months ago and the patient had no adverse effects.        In the evening on 15-MAY-2019 and 16-MAY-2019(reported as last evening and today), the patient felt under the weather, like he had a cold with sore throat, cold symptoms and kinda feverish. The patient did have a sore throat on Monday evening. The patient did not seek medical attention. No treatment was given for the event.    The outcome of cold was reported as not recovered. The causality between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 71 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 06-JUL-2013, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a physician for herpes zoster. The outcome of the events herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 70 year old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced herpes zoster. On an unspecified date, the patient was treated by a healthcare provider for herpes zoster. The outcome of the events herpes zoster was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 68 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On or around 27-JAN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions.   On an unspecified date, the patient experienced Herpes Zoster. On an unspecified date, the patient was treated by a physician for Herpes Zoster. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 74 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 66 year old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications. In 2016, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles . On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).   Additional information has been requested.