chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Abdominal pain, Arthralgia, Back pain, Decreased appetite, Headache
Clinical narrative: iNJECTION SITE SWOLLEN, HOT AND PAINFUL EXTENDING TO ELBOW. DEVELOPED PAIN IN BACK, JOINTS AND MUSCLES. FEVER  VARIED FROM 100.3 TO 103.1 (PATIENT BASAL TEMP 97.1). LOSS OF APPETITE, HEADACHE AND GENERALIZED MALAISE. SYMPTOMS PERSISTED FOR 48 HOURS. RESOLVED FOLLOWING ABDOMINAL CRAMPING AND BOWEL MOVEMENT.
Age: 70.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Malaise, Myalgia
Clinical narrative: iNJECTION SITE SWOLLEN, HOT AND PAINFUL EXTENDING TO ELBOW. DEVELOPED PAIN IN BACK, JOINTS AND MUSCLES. FEVER  VARIED FROM 100.3 TO 103.1 (PATIENT BASAL TEMP 97.1). LOSS OF APPETITE, HEADACHE AND GENERALIZED MALAISE. SYMPTOMS PERSISTED FOR 48 HOURS. RESOLVED FOLLOWING ABDOMINAL CRAMPING AND BOWEL MOVEMENT.
Age: 70.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Pyrexia
Clinical narrative: iNJECTION SITE SWOLLEN, HOT AND PAINFUL EXTENDING TO ELBOW. DEVELOPED PAIN IN BACK, JOINTS AND MUSCLES. FEVER  VARIED FROM 100.3 TO 103.1 (PATIENT BASAL TEMP 97.1). LOSS OF APPETITE, HEADACHE AND GENERALIZED MALAISE. SYMPTOMS PERSISTED FOR 48 HOURS. RESOLVED FOLLOWING ABDOMINAL CRAMPING AND BOWEL MOVEMENT.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site inflammation, Injection site warmth, Nodule, Pruritus
Clinical narrative: Patient has a big, red bullseye spot at the site of injection that is hot to the touch and inflammed. There is a nodule below the site of injection. Patient has reported some itching as well.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Burning sensation, Eyelid ptosis, Facial pain, Loss of personal independence in daily activities, Neck pain
Clinical narrative: 17 yo F with history of hypermobility syndrome and chronic pain, autonomic instability here for possible vaccine reaction. Was seen 12/12/17 for impetigo, on left upper outer thigh on antibiotics for this. Seems to be getting better less drainage. Did have a new spot come up at back of neck. She is taking cephalexin as prescribed 500 mg TID and applying mupirocin. Got MCV vaccine at that appointment into left upper arm. Felt achy following day. On Friday ached up arm and face/neck, seemed to have difficulty keeping eye on that side open/droopy eyelid. Called and referred to urgent care (notes not available), felt likely adverse reaction to vaccination, told to follow-up if difficulty breathing or other signs of allergy so returned for feeling of lump in her throat, had a negative strep test at that time. She is feeling pins and needles now on arm, neck, burning feeling as well. Has been distracting her and keeping her from normal activities. She is using strategies learned at her away camp at Clinic including distraction and staying busy and deep breathing but these sensations are different. Otherwise she is eating and drinking normally, breathing without difficulty, no nausea/vomiting/diarrhea.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Pain, Pain in extremity, Paraesthesia
Clinical narrative: 17 yo F with history of hypermobility syndrome and chronic pain, autonomic instability here for possible vaccine reaction. Was seen 12/12/17 for impetigo, on left upper outer thigh on antibiotics for this. Seems to be getting better less drainage. Did have a new spot come up at back of neck. She is taking cephalexin as prescribed 500 mg TID and applying mupirocin. Got MCV vaccine at that appointment into left upper arm. Felt achy following day. On Friday ached up arm and face/neck, seemed to have difficulty keeping eye on that side open/droopy eyelid. Called and referred to urgent care (notes not available), felt likely adverse reaction to vaccination, told to follow-up if difficulty breathing or other signs of allergy so returned for feeling of lump in her throat, had a negative strep test at that time. She is feeling pins and needles now on arm, neck, burning feeling as well. Has been distracting her and keeping her from normal activities. She is using strategies learned at her away camp at Clinic including distraction and staying busy and deep breathing but these sensations are different. Otherwise she is eating and drinking normally, breathing without difficulty, no nausea/vomiting/diarrhea.
Age: 51.0
Sex: M
Vaccine: FLUC4
Symptoms: Facial paralysis, Lacrimation increased, Muscle disorder
Clinical narrative: I was diagnosed with Bell's Palsy. Half of my face began to droop. My right eye watered continuously 3 days after word. I can only smile on the left side of my face. The muscles on the right side of my face simply will not work. I have never had anything like this occur and had no previous sickness in over a year. I am currently being treated with prednisone and valacyclovir.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Migraine
Clinical narrative: Patient has had a severe headache (migraine) since injection.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient experienced redness, swelling and soreness at the site of the injection.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large red swelling at the injection site. Still swollen 1 month after injection.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site pruritus, Pruritus
Clinical narrative: Patient presented with redness and itching in right arm where vaccine was injected and along inside of arm.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site abscess, Injection site discolouration, Injection site swelling
Clinical narrative: My son was given these same vaccinations on October 20, 2017. I did not notice swelling and discoloration in the first doses but with the second series, the adverse reactions are very noticeable. There is swelling at the site of each intramuscular injection in both thighs. Two vaccinations were administered to his left thigh and the swelling there is larger. It feels like there is a mass under my baby's skin. On the left thigh there is also a dark spot that was not there prior to this second dose of vaccines. I believe the PEDIARIX combination was injected into my son's right thigh where there is some swelling under the skin and a small bump on the top layer of skin. The doctor stated that this is a common reaction. She advised me to massage the affected areas and to apply cold compresses to the affected sites.
Age: 0.33
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Intestinal operation, Intussusception
Clinical narrative: Intussusception->surgical repair.
Sex: U
Vaccine: FLU4
Symptoms: Injection site joint pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site joint pain in a patient who received Influenza vaccine Quadrivalent unspecified. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified, the patient experienced injection site joint pain. On an unknown date, the outcome of the injection site joint pain was unknown. It was unknown if the reporter considered the injection site joint pain to be related to Influenza vaccine Quadrivalent unspecified. Additional details were received as follows: The reporter stated that she needed to get the Flu shot but had experienced chronic shoulder pain where the previous Flu shot was administered. The reporter asked whether she could receive the Flu shot in thigh. No other information was known, including whether chatter was a health care professional or not, contact information, or the brand of vaccine.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site warmth in a 66-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Concurrent medical conditions included drug allergy (sensitivity to other medications and contrast injection in the past). On 4th December 2017, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In December 2017, 12 hrs after receiving SHINGRIX, the patient experienced injection site warmth, injection site swelling and injection site pain. The patient was treated with diphenhydramine. On an unknown date, the outcome of the injection site warmth, injection site swelling and injection site pain were recovering/resolving. The reporter considered the injection site warmth, injection site swelling and injection site pain to be almost certainly related to SHINGRIX. Additional details were provided as follows: The patient receiving SHINGRIX vaccine in left deltoid at 9:45 am after working 3rd shift. The patient experienced warmth, swelling and soreness at the site of SHINGRIX, which began approximately 12 hours following injection. The patient returned to the health care professional 2 days after the injection whereupon the health care professional confirmed the reaction and administered oral diphenhydramine. The patient was scheduled to report results to the health care professional this afternoon.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Nausea, Vomiting
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of vomiting in a 17-year-old female patient who received BEXSERO (batch number 16D301, expiry date February 2019). On 5th December 2017 15:30, the patient received BEXSERO. In December 2017, 16 hrs after receiving BEXSERO, the patient experienced vomiting and nausea. On an unknown date, the outcome of the vomiting and nausea were not recovered/not resolved. The reporter considered the vomiting and nausea to be probably related to BEXSERO. Additional details were provided as follows: The healthcare professional reported that the patient started with the nausea and vomiting symptoms the next morning of vaccination at school, and the patient's mother had to pick the patient up from school. The healthcare professional stated that they would come in for follow up visit at office but had not been confirmed with mother of the patient at the time of call. The reporter was pretty sure that the vaccine caused the symptoms.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: This case was reported by a other health professional and described the occurrence of vomiting in a patient who received BEXSERO (batch number 16D301, expiry date February 2019). On an unknown date, the patient received BEXSERO. On an unknown date, 1 day after receiving BEXSERO, the patient experienced vomiting. On an unknown date, the outcome of the vomiting was unknown. It was unknown if the reporter considered the vomiting to be related to BEXSERO. Additional details were provided as follows: This case was reported by the Medical Assistant. The age at the vaccination was not reported. On Monday at 3:30 pm, the patient was administered BEXSERO. The patient had to be picked up from school on Tuesday morning with bad vomiting. The physician believed this might be the 3rd or 4th patient that has had vomiting after receiving a BEXSERO dose since July 2017.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Lymphadenopathy
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of enlargement of lymph nodes in a 17-year-old female patient who received BEXSERO. On 5th July 2017, the patient received BEXSERO (intramuscular) .5 ml. In July 2017, 3 days after receiving BEXSERO, the patient experienced enlargement of lymph nodes. On an unknown date, the outcome of the enlargement of lymph nodes was recovered/resolved. The reporter considered the enlargement of lymph nodes to be unrelated to BEXSERO. Additional details were provided as follows: The age at vaccination was not provided. The patient had lymph node swelling in the clavicle area. The patient's lymph node was later removed and date of removal was unknown. The patient required emergency room visit.
Age: 17.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient awoke 12/15/17 with hives, itchy skin. Mother contacted clinic, advised to take OTC BENADRYL or ZYRTEC, use hydrocortisone on itchy areas, or aloe vera to calm skin. Advised to monitor. Go to ER if swelling or difficulty breathing occurs.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Temp to 100.2 (rectally) after imms no redness/streaks/swelling or pain.
Age: 37.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Dyspnoea, Hypoaesthesia, Injected limb mobility decreased, Neck pain, Pain
Clinical narrative: Arm and neck pain, loss of motion in left arm numbness of fingers that eventually turned to full numbness of left arm. Pt then had body aches and vomiting for several hours. SOB.
Age: 37.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pain in extremity, Vomiting
Clinical narrative: Arm and neck pain, loss of motion in left arm numbness of fingers that eventually turned to full numbness of left arm. Pt then had body aches and vomiting for several hours. SOB.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Extra dose administered
Clinical narrative: Misadministration of flu vaccine. Previous flu vaccine had been administered on 10/27/2017; the next vaccine was not due until next flu season.
Age: 1.5
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Eye swelling, Injection site erythema, Injection site swelling, Swelling face
Clinical narrative: Per mom, child was doing well after vaccines then noted progressive redness and swelling to left thigh; this morning awoke with swelling to left eye area and cheek. No respiratory distress, no oral symptoms. MD provided antibiotics, BENADRYL, and prednisolone. Follow-up scheduled for 12/18/17, sooner if not getting better.
Age: 48.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Impaired work ability, Injected limb mobility decreased, Injection site erythema, Injection site swelling, Vaccination complication
Clinical narrative: Patient presented to clinic 2 days after injection stating she had a reaction to one of the two vaccines given to her. She had severely swelling and redness to right side from shoulder to below breast. She states she has not been able to use her right arm and missed 2 days of work due to the swelling. When I tried to shake her hand she couldn't lift her right arm/hand and offered her left arm/hand as a greeting.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Receive vaccine 9/11 by next day began having pain, swelling, redness, hot to the touch, by 9/15 at urgent care, arm red from above site of admin. to below elbow. Diagnosis: cellulitis as a result of shot. Sentinel node dissection in left arm - why shots only in right arm. Cephalexin 250 mg 4 cap bid x 10 days, all symptoms except pain began resolving approximately 10 days after beginning Abx. 3 mo after vaccine and still in lots of pain. Pain 11 out of 10 middle arm but radiates to shoulder and lower arm w/certain daily movements.
Age: 66.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pain, Pain in extremity
Clinical narrative: Receive vaccine 9/11 by next day began having pain, swelling, redness, hot to the touch, by 9/15 at urgent care, arm red from above site of admin. to below elbow. Diagnosis: cellulitis as a result of shot. Sentinel node dissection in left arm - why shots only in right arm. Cephalexin 250 mg 4 cap bid x 10 days, all symptoms except pain began resolving approximately 10 days after beginning Abx. 3 mo after vaccine and still in lots of pain. Pain 11 out of 10 middle arm but radiates to shoulder and lower arm w/certain daily movements.
Age: 82.0
Sex: F
Vaccine: FLUA3, PNC13, TDAP
Symptoms: Injection site pruritus, Injection site rash, Pruritus, Rash
Clinical narrative: Itching and rash on left arm. Itching on left hand down to injection site. Patient states injection site has rash, is on lower biceps about a grapefruit in size, patient sent to urgent care.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Computerised tomogram head normal, Contusion, Epistaxis, Laceration, Suture insertion
Clinical narrative: Patient fainted in parking lot. Cut on chin, bruise on forehead, bloody nose, chipped tooth.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Syncope, Tooth fracture
Clinical narrative: Patient fainted in parking lot. Cut on chin, bruise on forehead, bloody nose, chipped tooth.
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, FLU4, HPV9
Symptoms: Computerised tomogram head normal, Loss of consciousness, Suture insertion, Tooth fracture
Clinical narrative: Patient fainted in parking lot. Cut on chin, bruise on forehead, bloody nose, chipped tooth.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. On or about 10-DEC-2008, the patient was inoculated at a pharmacy with ZOSTAVAX (lot number, dosage, and route of administration not provided), as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 21-DEC-2015, the patient was treated by a physician  for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as acute trigeminal herpes zoster, a serious complication of zoster infections. The patient has been prescribed gabapentin for management of her painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering , and other damages. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Erythema, Pain of skin, Skin warm
Clinical narrative: Pt complained of reddening, tenderness and pain of the LUE. Upon examination the site was noted to be the size of a baseball. Pt was diagnosed with cellulitis.
Age: 18.0
Sex: F
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Erythema, Injection site swelling, Pain in extremity, Tenderness
Clinical narrative: Pt complained of reddening, tenderness and pain of the LUE. Upon examination the site was noted to be the size of a baseball. Pt was diagnosed with cellulitis.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Rash erythematous
Clinical narrative: Received immunization at clinic around 2:00 pm. By the evening on that same day noticed scattered raised pink rash over left arm and dorsum of hand, mild amount on dorsum of right hand and forearm. Rash also developed onto her torso and bilateral thighs.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Joint range of motion decreased, Peripheral swelling, Pyrexia
Clinical narrative: Swelling, Redness that went around whole arm, fever, and loss of range of motion temporarily. Patient contacted her PCP who prescribed her KEFLEX on day 3 and range of motion was back by day 4.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Injection site swelling, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Intense pain in left shoulder beginning several hours after injection. Unable to lift arm more than a few inches for first few days after injection, had to sleep sitting up for first several days to avoid pressure on shoulder, used over-the-counter meds round-the-clock. Saw physician on Dec. 11, who diagnosed significant swelling in the deltoid muscle in left shoulder, recommended gentle exercises, physical therapy if pain continued. Gradual improvement in range of motion but still painful and unable to resume normal activities (tennis, yoga). First appointment with physical therapist scheduled for Dec. 22.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a patient of unknown age or gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with PROQUAD (strength, dose, lot #, expiration date and anatomical location were not reported) intramuscularly for prophylaxis; which was reconstituted with sterile water diluent (manufacturer unknown) (lot # and expiration date not reported). No adverse effects reported and no additional information was provided. Follow up information was from the medical assistant on 08-JUN-2017, concerning 4 year old female patient. The patient's concomitant medications included KINRIX. The reporter stated that, on 02-MAY-2017 at 1:52 p.m., the patient was vaccinated with PROQUAD (lot# M044019) dose 2, intramuscular in the left thigh for prophylaxis. Lot number M044019 (rHA) has been verified to be a valid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live. Additional information is not expected as all schedule follow up information was received. This is an amended report, as corrected. The suspect drug was corrected from Sterile Water (MK 9446) to sterile diluent (MK 9395).
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 19-OCT-2017, the patient was vaccinated with an expired dose of PROQUAD lot number L050909 and expiration date of 14-JUN-2017 for prophylaxis. No adverse effects were reported.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information has been received from a nurse referring to a 49 years old female patient. On 27-SEP-2017, the patient was vaccinated with FLUZONE high dose (lot # UI870AA, intramuscular). Drug Reactions/Allergies included aspirin, oxycodone hydrochloride, oxycodone terephthalate (PERCODAN). There was no illness at the time of vaccination. Concomitant therapies included senna (SENOKOT) and multivitamins. On 13-NOV-2017, the patient was vaccinated with a PNEUMOVAX 23 (lot # N014946, expiration date 01-FEB-2019) subcutaneously for prophylaxis. On 14-NOV-2017, the patient developed a spot 3 inches below injection site and the site of injection at upper arm was red/erythema, warm, swollen/swelling and tenderness. On the same day, the patient visited physician office. On an unknown date in 2017, the patient started on cephalexin (KEFLEX) (500mg, twice a day (bid), oral (PO), 7days) and diphenhydramine hydrochloride (BENADRYL) as treatment for the events (also reported as no prescription drug treatment for the experience required). There was no lab diagnostics/studies performed. There was no temperature excursion occur as a result from a Digital Data Logger. The outcome of the events was recovered on an unknown date in November 2017. The causality between PNEUMOVAX 23 and the events was unknown.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to an unspecified number of patients who were 13 years old and older. The patients' concomitant therapy, concurrent condition and medical history were unknown. On an unknown date, the patients were vaccinated with an unspecified number of doses of PROQUAD (dose, frequency and route were unknown, lot # N012489, expiration date:17-OCT-2017) for prophylaxis(drug administered to patient of inappropriate age). No adverse effects reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 22-NOV-2017, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route of administration were not provided) lot# N020014 and expiration date: 17-JUL-2019. The VARIVAX was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported. The vaccine was stored in between 6 degrees Fahrenheit (F) to 14 F for 1 hour and 35 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion.; Sender's Comments: US-009507513-1712USA009051:
Sex: F
Vaccine: FLUX, PPV
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a 71 year old female patient. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in October 2017, the patient was co-administrated a dose (reported as "one shot") PNEUMOVAX 23 (exact dose, route of administration, lot# and expiry date were not reported) for prevention of pneumonia and an unspecified "high dose flu vaccine". On an unknown date in 2017, the patient developed feelings of weakness and achiness as well as red, painful swelling at the injection site. Both vaccines were administered in the same arm, but it was not known by the reporter whether both vaccines were administered in the left arm or the right arm. The patient sought medical attention and was given an unspecified treatment for the events. The patient was not hospitalized. The outcome of the events was unknown. The reporter's causality assessment between the events and the PNEUMOVAX and unspecified flu vaccine was not reported. This is one of the two reports received from the same reporter.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 11-DEC-2017, the patient was vaccinated with VAQTA lot # N019924 with expiration date on 02-SEP-2018 (strength, dose, route of administration were unspecified) for prophylaxis. The suspected vaccine was improperly stored in temperature between 9 Celsius degrees and 25 Celsius degrees for 1 hour and 6 minutes. No adverse effects was reported. The digital data logger was involved. No previous temperature excursions were reported. This is one of two case reports received from the same reporter. Sender's Comments: US-009507513-1712USA009061.
Age: 1.5
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 18 month old patient of an unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 20-NOV-2017, the patient was vaccinated with PROQUAD lot # N014759 for prophylaxis (dose, route of administration, expiration date and anatomical location were not reported) and VARIVAX lot# M048200 with an expiration date 07-DEC-2018 (dose, route of administration and anatomical location were not reported). No adverse effects was reported. This is one of two reports received from the same reporter.; Sender's Comments: US-009507513-1712USA009053:
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received on 15-DEC-2017 from a lawyer regarding a case in litigation and refers to a male patient of unknown age. Medical history, concurrent conditions, and concomitant medications were not provided. The patient was inoculated with ZOSTAVAX on or about 03-OCT-2012, at a pharmacy, (by an unspecified person) as recommended for routine adult health maintenance and for the prevention of shingles (dose, route of administration, site of administration and lot # were not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 25-JUL-2015, the patient was treated by a clinic (by an unspecified person), for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient has been prescribed VALTREX for management of his painful symptoms. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages. The outcome of the events was not resolved. The lawyer felt the events were related to ZOSTAVAX. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular, Varicella virus test positive
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medications. The patient was inoculated with ZOSTAVAX (lot number, dosage and route of administration not provided) on or about 13-DEC-2012, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles. On or about 21-FEB-2016, the patient was treated at a clinic for the onset of a blistery rash accompanied by weakened immune symptoms, which tested positive for varicella-zoster, indicating a current zoster infection. As a direct and proximate result of these malfunctions, the patient has suffered and will continue to suffer significant medical expenses, lost wages, pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 30-NOV-2017, the patient was vaccinated with improperly stored dose of VARIVAX (dose, frequency and route of administration were not provided) lot# N020014 and expiration date: 17-JUL-2019. The VARIVAX was reconstituted with properly stored dose of sterile diluent (manufacturer unknown). No adverse effect was reported.  The vaccine was stored between 6 degrees Fahrenheit (F) to 14 F for 1 hour and 35 minutes. There was no previous temperature excursion. The digital data logger was involved in recording the temperature excursion.; Sender's Comments:  US-009507513-1712USA001512:
Age: 1.5
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a 18 month old patient of an unknown gender. The patient's pertinent medical history, drug reactions and allergies were not reported. Information regarding concomitant therapies was not provided. On 20-NOV-2017, the patient was vaccinated with PROQUAD (unknown albumin status) lot # N014759 for prophylaxis (dose, route of administration, expiration date and anatomical location were not reported) and VARIVAX lot# M048200 with an expiration date 07-DEC-2018 (dose, route of administration and anatomical location were not reported). No adverse effects was reported. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1712USA008472.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to a patient of unknown age and gender. No information regarding the patient's medical history, concurrent conditions and concomitant medications was provided. On 11-DEC-2017, the patient was vaccinated with VAQTA lot # N019924 with expiration date on 02-SEP-2018 (strength, dose, route of administration were unspecified) for prophylaxis. The suspected vaccine was improperly stored in temperature between 9 Celsius degrees and 25 Celsius degrees for 1 hour and 6 minutes. No adverse effects was reported. The digital data logger was involved. No previous temperature excursions were reported. This is one of two case reports received from the same reporter. Sender's Comments: US-009507513-1712USA005657.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Computerised tomogram, Electroencephalogram, Intensive care, Nuclear magnetic resonance imaging
Clinical narrative: I know that it was a seasonal Influenza vaccine but do not know the kind or manufacturer. She had a very serious seizure on the 6th day after receiving the flu vaccine. At 11:19 AM the seizure lasted 30 minutes and she had to be given medication to bring her out of it. My granddaughter is a very healthy 4 year old and this came out of nowhere. She was transported to the emergency room and then was transferred to the PICU and she is now on the regular peds floor. She is currently still in the hospital and they are running test so I don't know the outcome as of yet.
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Seizure, Urine analysis
Clinical narrative: I know that it was a seasonal Influenza vaccine but do not know the kind or manufacturer. She had a very serious seizure on the 6th day after receiving the flu vaccine. At 11:19 AM the seizure lasted 30 minutes and she had to be given medication to bring her out of it. My granddaughter is a very healthy 4 year old and this came out of nowhere. She was transported to the emergency room and then was transferred to the PICU and she is now on the regular peds floor. She is currently still in the hospital and they are running test so I don't know the outcome as of yet.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Fatigue, Headache
Clinical narrative: 6 hrs after shot patient started having watery diarrhea. The following day patient continued with diarrhea, headache, low appetite and was very tired (very unlike patient). The next day, Sunday, patient awoke in morning with fever 100.7, diarrhea, chest congestion, sore throat, nausea and stomach cramps. As the day progressed, fever worsened to 101.9, and large 2-3 inch burgundy marks started to appear on front shoulder of left arm. These marks started appearing moving down the arm, then by late night developed on right shoulder & arm as well. Fever, sore throat, chest congestion continued to occur and vomiting began. Monday the fever, cough, sore throat worsened and patient is very lethargic with no appetite. Rash stayed the same. Tuesday, patient continues to have a headache, sore throat, diarrhea, cough/congestion, and fever.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Lethargy, Nausea, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: 6 hrs after shot patient started having watery diarrhea. The following day patient continued with diarrhea, headache, low appetite and was very tired (very unlike patient). The next day, Sunday, patient awoke in morning with fever 100.7, diarrhea, chest congestion, sore throat, nausea and stomach cramps. As the day progressed, fever worsened to 101.9, and large 2-3 inch burgundy marks started to appear on front shoulder of left arm. These marks started appearing moving down the arm, then by late night developed on right shoulder & arm as well. Fever, sore throat, chest congestion continued to occur and vomiting began. Monday the fever, cough, sore throat worsened and patient is very lethargic with no appetite. Rash stayed the same. Tuesday, patient continues to have a headache, sore throat, diarrhea, cough/congestion, and fever.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Skin discolouration, Vomiting
Clinical narrative: 6 hrs after shot patient started having watery diarrhea. The following day patient continued with diarrhea, headache, low appetite and was very tired (very unlike patient). The next day, Sunday, patient awoke in morning with fever 100.7, diarrhea, chest congestion, sore throat, nausea and stomach cramps. As the day progressed, fever worsened to 101.9, and large 2-3 inch burgundy marks started to appear on front shoulder of left arm. These marks started appearing moving down the arm, then by late night developed on right shoulder & arm as well. Fever, sore throat, chest congestion continued to occur and vomiting began. Monday the fever, cough, sore throat worsened and patient is very lethargic with no appetite. Rash stayed the same. Tuesday, patient continues to have a headache, sore throat, diarrhea, cough/congestion, and fever.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Vaccination complication
Clinical narrative: 6 hrs after shot patient started having watery diarrhea. The following day patient continued with diarrhea, headache, low appetite and was very tired (very unlike patient). The next day, Sunday, patient awoke in morning with fever 100.7, diarrhea, chest congestion, sore throat, nausea and stomach cramps. As the day progressed, fever worsened to 101.9, and large 2-3 inch burgundy marks started to appear on front shoulder of left arm. These marks started appearing moving down the arm, then by late night developed on right shoulder & arm as well. Fever, sore throat, chest congestion continued to occur and vomiting began. Monday the fever, cough, sore throat worsened and patient is very lethargic with no appetite. Rash stayed the same. Tuesday, patient continues to have a headache, sore throat, diarrhea, cough/congestion, and fever.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Abdominal pain upper, Decreased appetite, Diarrhoea, Fatigue, Headache
Clinical narrative: My child had several serious side effects after receiving the GARDASIL vaccine.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Lethargy, Nausea, Oropharyngeal pain, Pyrexia, Respiratory tract congestion
Clinical narrative: My child had several serious side effects after receiving the GARDASIL vaccine.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Skin discolouration, Vomiting
Clinical narrative: My child had several serious side effects after receiving the GARDASIL vaccine.
Age: 14.0
Sex: M
Vaccine: HPV9, HPV4
Symptoms: Vaccination complication
Clinical narrative: My child had several serious side effects after receiving the GARDASIL vaccine.
Age: 0.33
Sex: M
Vaccine: DTAP, RV5
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None stated.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Body temperature decreased, Chills, Headache, Nausea, Tremor
Clinical narrative: Within 1 hour after vaccine was given, teen called back experiencing severe shaking chills, severe headache, nausea and vomiting. We brought her back into the office and observed her another hour. She was noted to have an oral temperature of 95 degrees F on arrival and shaking chills. After about 30 minutes of intermittent vomiting and shaking under a blanket her temperature had improved to 97 degrees F and vomiting subsided. She tolerated 600 mg ibuprofen. We monitored her another 30 min and she sated her headache was improving and she wished to go home to rest. Called mom back this afternoon: mom stated she rested a couple hours in bed and woke up feeling much better with no headache or nausea and normal temperature.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Within 1 hour after vaccine was given, teen called back experiencing severe shaking chills, severe headache, nausea and vomiting. We brought her back into the office and observed her another hour. She was noted to have an oral temperature of 95 degrees F on arrival and shaking chills. After about 30 minutes of intermittent vomiting and shaking under a blanket her temperature had improved to 97 degrees F and vomiting subsided. She tolerated 600 mg ibuprofen. We monitored her another 30 min and she sated her headache was improving and she wished to go home to rest. Called mom back this afternoon: mom stated she rested a couple hours in bed and woke up feeling much better with no headache or nausea and normal temperature.
Age: 65.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema multiforme, Pruritus, Urticaria
Clinical narrative: Erythema Multiform and Urticaria Pruritus.
Age: 27.0
Sex: M
Vaccine: DTP
Symptoms: Blood magnesium, Blood phosphorus, Contraindicated product administered, Differential white blood cell count, Dizziness
Clinical narrative: Pt received vaccine at outside facility on 8/1/17. Pt presented to emergency department on 8/2/17 with complaints of swelling in right arm (injection site), fatigue, and dizziness. Pt's mother had told him that he is allergic to Td vaccine after he received it on 8/1/17. Pt was admitted overnight for observation after presentation to emergency department. Methylprednisolone 125 mg once, cetirizine 10 mg once, famotidine 20 mg once.
Age: 27.0
Sex: M
Vaccine: DTP
Symptoms: Fatigue, Full blood count, Injection site swelling, Laboratory test, Staphylococcus test
Clinical narrative: Pt received vaccine at outside facility on 8/1/17. Pt presented to emergency department on 8/2/17 with complaints of swelling in right arm (injection site), fatigue, and dizziness. Pt's mother had told him that he is allergic to Td vaccine after he received it on 8/1/17. Pt was admitted overnight for observation after presentation to emergency department. Methylprednisolone 125 mg once, cetirizine 10 mg once, famotidine 20 mg once.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Pt calls to say she received a PNEUMOVAX injection on 8-15-17 in her left arm She is now complaining of her arm being swollen and red down to her wrist. It is also painful, 8/10, she took her Tramadol which helped the pain. She has been using ice. Denies that it feels warm.
Age: 85.0
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Headache, Heart rate increased, Hypertension, Tachycardia
Clinical narrative: Pt developed severe HTN SBP>200, moderate tachycardia, and headache shortly after FLUVAX injection 10/5/17 (see LPN note). Vitals steadily normalized over the course of 15 minutes. Would use caution with administration of future flu vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On 14-NOV-2017, the patient was vaccinated with a dose of ZOSTAVAX lot # M040146, for prophylaxis (strength, dose, route, frequency and expiration date were not reported). On an unknown date in November 2017, the patient got a "big rash on his arm towards the elbow, the size of a softball with welts". The patient followed up with his primary physician who prescribed an unspecified cream and a possible steroid injection (unknown date). The outcome of urticarial rash was unknown. The causality between urticarial rash and ZOSTAVAX was not reported.
Age: 79.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Bacteraemia, Dyspnoea, Joint injury, Limb injury, Pneumonia
Clinical narrative: This spontaneous report has been received from a 79 year old male consumer, who is referring on himself. The patient's medical history included penicillin allergy. Concomitant medications included unspecified blood pressure medication. In May 2016, the patient was vaccinated with an unspecified pneumonia vaccine(manufacturer unknown) for prevention of pneumonia, route of administration reported as "injection", dose/frecuency reported as "one shot" (anatomical location, lot number and expiration date were not reported). On an unspecified day  in May 2016, reported as "around May" , the patient reported that he injured his leg and knee and he did not remember whether the leg and knee injury occurred before or after receiving the vaccine. On 15-OCT-2016, the patient went to the gym and then early in the morning on 16-OCT-2016, he had extreme difficulty breathing; the same day, he was hospitalized  and was there for 4 or 5 days; during this time, lab tests were performed, and the patient was determined to have "bacteremia and septicemia." A blood culture revealed that streptococcus was in the patient's blood. It was reported that test result "scared" the patient and the unspecified hospital doctor. While hospitalized, the patient was treated with unspecified IV antibiotics for about 4 days. After he was released from the hospital, he was prescribed "10 days" of both vancomycin and another unspecified medication. The patient's outcome regarding the events of leg and knee injury, bacteraemia and sepsis was unknown, and, the outcome of pneumonia was reported as recovering as he still experienced increased difficulty breathing. The reporter did not assess the causality between the adverse events and PNEUMOVAX 23. Upon internal review the events of pneumonia, bacteraemia and sepsis were considered to be medically significant.
Age: 79.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Sepsis, Streptococcus test positive
Clinical narrative: This spontaneous report has been received from a 79 year old male consumer, who is referring on himself. The patient's medical history included penicillin allergy. Concomitant medications included unspecified blood pressure medication. In May 2016, the patient was vaccinated with an unspecified pneumonia vaccine(manufacturer unknown) for prevention of pneumonia, route of administration reported as "injection", dose/frecuency reported as "one shot" (anatomical location, lot number and expiration date were not reported). On an unspecified day  in May 2016, reported as "around May" , the patient reported that he injured his leg and knee and he did not remember whether the leg and knee injury occurred before or after receiving the vaccine. On 15-OCT-2016, the patient went to the gym and then early in the morning on 16-OCT-2016, he had extreme difficulty breathing; the same day, he was hospitalized  and was there for 4 or 5 days; during this time, lab tests were performed, and the patient was determined to have "bacteremia and septicemia." A blood culture revealed that streptococcus was in the patient's blood. It was reported that test result "scared" the patient and the unspecified hospital doctor. While hospitalized, the patient was treated with unspecified IV antibiotics for about 4 days. After he was released from the hospital, he was prescribed "10 days" of both vancomycin and another unspecified medication. The patient's outcome regarding the events of leg and knee injury, bacteraemia and sepsis was unknown, and, the outcome of pneumonia was reported as recovering as he still experienced increased difficulty breathing. The reporter did not assess the causality between the adverse events and PNEUMOVAX 23. Upon internal review the events of pneumonia, bacteraemia and sepsis were considered to be medically significant.