chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 79.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Dyspnoea, Pneumonia streptococcal, Sputum retention, Streptococcus test positive, X-ray
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.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age.  No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 07-JAN-2016, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route 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 24-MAY-2016, the patient was treated by a physician for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed valacyclovir (VATREX) and tramanolone 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, and pain and suffering, and other damages. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 09-JAN-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route 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 24-JUL-2017, the patient was treated at a Family Practice for the onset of blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. 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 unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 06-OCT-2015, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route 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 08-DEC-2016, the patient was treated by a physician at a Family Medicine Center for the onset of blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was 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. The outcome of the events was unknown. Causality assessment was related. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Post herpetic neuralgia, 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 30-DEC-2015, 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 13-MAR-2017, the patient was treated by a physician assistant  for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles which had begun to break out in November of 2015, and had manifested persistently for nearly two years. On or about 21-MAR-2107, the patient was treated again for ongoing and worsening pain, at which time she was also diagnosed with post-herpetic neuralgia, a chronic condition of nerve damage and pain secondary to shingles infections. The patient has been prescribed valacyclovir hydrochloride (VALTREX) (in incrementally increasing doses), biofreeze, lidocaine, gabapentin, aspercreme, and valacyclovir 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: 4.0
Sex: M
Vaccine: DTAP, FLU4, IPV, MMR, VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Next day after receiving shots (12/15/17) looked to hve large red area extending past bandaid where shots were given.  On 12/181/7 mom called states arem is red from shoulder to elbow, swollen, not warm, but area feels hard. Pt seen on 12/18/17 R upper arm from deltoid muscle to elbow with redness, firmness, warmth, swelling, non tender to palp, full strength and ROM, no streaking.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Swelling, Wrong technique in product usage process
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 5-year-old male patient who received FLUARIX Quadrivalent (batch number 29PD2, expiry date unknown). Previously administered products included Flu vaccine (experienced reaction after vaccination). Concurrent medical conditions included asthma. Concomitant products included Measles Mumps Rubella, Albuterol and FLOVENT. On 2nd November 2016, the patient received FLUARIX Quadrivalent .5 ml. On an unknown date, 1 day after receiving FLUARIX Quadrivalent, the patient experienced erythema and swelling. On an unknown date, the outcome of the erythema and swelling were recovered/resolved. The reporter considered the erythema and swelling to be related to FLUARIX Quadrivalent. Additional information was reported as follows: The patient's mother reported that the patient was vaccinated with the suspect vaccine on the left arm. She states that the patient experienced a reaction after the vaccination and the events resolved within 24 to 36 hours later. She states that the events were not as severe as that of his brother. The patient's brother did not face any reaction after vaccination in 2015. The patient's mother describes that the, he had received MMR and possibly other vaccine 4 weeks within the flu vaccine. She states this year he received the FLUZONE and was having the same issues but not as severe. She noted the dermatologist had done skin testing but he still had a reaction. She also noted this year the vaccine was given as split doses, one in each bicep area. The patient was treated with BENADRYL. This case has been linked case US2017GSK195238, reported by the same reporter for the same patient.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Drug administered at inappropriate site, Myositis
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of myositis in a 18-year-old female patient who received BEXSERO. In June 2017, the patient received the 1st dose of BEXSERO. In June 2017, unknown after receiving BEXSERO, the patient experienced vaccine administered at inappropriate site. On an unknown date, the patient experienced myositis. On an unknown date, the outcome of the myositis was recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown. The reporter considered the myositis to be related to BEXSERO. Additional details were received as follows: The age at vaccination was not reported. The patient received BEXSERO in an unknown thigh, which led to vaccine administered at inappropriate site. The reporter did not know the reason for medication error. In 2017, less than a year after vaccination, the patient experienced Myositis and the reporter thought that Myositis lasted for 2 weeks. The patient did not receive 2nd dose of BEXSERO. The reporter did not agree to receive follow up from GlaxoSmithKline.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Gave 0.5 dose to child 2 years age.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Vaccine was not viable due to refrigerator temperature had been below freezing for an extended period of time. Verified with manufacturer the vaccine was not viable.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: Vaccine was not viable due to refrigerator temperature had been below freezing for an extended period of time. Verified with manufacturer the vaccine was not viable.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: New daily persistent headache
Clinical narrative: NDPH, new daily persistent headache.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site irritation, Injection site mass, Injection site pain, Injection site pruritus
Clinical narrative: Patient came into the pharmacy today (12/19/17) complaining of burning/itching at the injection site (left arm Subcutaneously). Patient did not have any other symptoms other than the burning/itching at the injection site. Upon examination, the site looked irritated (red, swollen, hot to the touch) and it did seem like there was a lump at the injection site. When asked how long this had been going on she said a few days. When asked about what the patient did to alleviate her discomfort she said nothing. Suggested putting ice on the site and taking some ibuprofen. I outlined the injection site with a Sharpie and told her if it goes outside the line to seek medical attention. Also if the irritation got worse to go see her doctor.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Patient came into the pharmacy today (12/19/17) complaining of burning/itching at the injection site (left arm Subcutaneously). Patient did not have any other symptoms other than the burning/itching at the injection site. Upon examination, the site looked irritated (red, swollen, hot to the touch) and it did seem like there was a lump at the injection site. When asked how long this had been going on she said a few days. When asked about what the patient did to alleviate her discomfort she said nothing. Suggested putting ice on the site and taking some ibuprofen. I outlined the injection site with a Sharpie and told her if it goes outside the line to seek medical attention. Also if the irritation got worse to go see her doctor.
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 5-year-old male patient who received FLUARIX QUADRIVALENT (batch number 29PD2, expiry date unknown). Concomitant products included MMR. On 2nd November 2016, the patient received FLUARIX QUADRIVALENT .5 ml. On an unknown date, 1 day after receiving FLUARIX QUADRIVALENT, the patient experienced erythema, pruritus and swelling. The patient was treated with BENADRYL and Steroids. On an unknown date, the outcome of the erythema, pruritus and swelling were recovered/resolved. The reporter considered the erythema and swelling to be related to FLUARIX QUADRIVALENT. The reporter considered the pruritus to be unlikely related to FLUARIX QUADRIVALENT. Additional information received as follows: The patient's mother reported that the patient received FLUARIX vaccine on left arm. The patient's mother stated that due to the red streaking, and the swelling of his upper bicep that spread to collar bone area and up to neck, she was encouraged to take him to the emergency department. He was given steroids there and within 24 to 36 hours later the issues were resolved. The patient's mother believed he had received an MMR and possibly another vaccine within 4 weeks of the flu shot. She stated that in 2017, he received FLUZONE and was having the same issues but not as severe. She noted that, the dermatologist had done skin testing but he still had a reaction. She also noted that the FLUZONE vaccine was given as split doses, one in each bicep area. She was treating him with BENADRYL. This case has been linked to the case US2017189700, reported by same reporter.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, RV5
Symptoms: Rash, Urticaria
Clinical narrative: 11/17 approximately 3 days after vaccines pt dev. rash on hands and feet, mom called re: rash on 11/18. Seen in office 11/20 with diffuse rash C/W Urticarial Multiforme no other S/S Tx with ZYRTEC resolved after 2-3 weeks.
Sex: U
Vaccine: MMR
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 was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On an unspecified date between 07-NOV-2017 and 20-NOV-2017, the patient was vaccinated with an improperly stored dose of M-M-R II for prophylaxis (dose, route of administration, lot number and expiration date were not reported). The temperature excursion was from 9 degrees Celsius (°C) to 25 °C, for a time frame of 6.5 hours, without a previous temperature excursion and was called because of a data logger. There was not product quality complaint or adverse event involved.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. On 26-NOV-2017, the patient was vaccinated with an expired dose of ZOSTAVAX dose and route were not reported (lot # M035692; expiration date 11-NOV-2017) for prophylaxis. It was reported that ZOSTAVAX was reconstituted with properly stored sterile diluent (manufacturer unknown) (lot # L014262, expiration date 17-FEB-2018) prior to administration. The primary reporter denied any adverse effects reported by patient. The outcome of expired product administered and no adverse event was unknown.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: This spontaneous report as received from a nurse refers to a 23-year-old female patient with asthma. Historical conditions included rash caused by penicillin. On 11-DEC-2017, the patient was vaccinated with M-M-R II lot # M047302, expiry date: 30-NOV-2018 for prophylaxis (dose, route and site of administration were not reported). Other suspect therapies included TUBERSOL. Concomitant therapies included VENTOLIN and unspecified birth control pills. On 11-DEC-2017 (reported as "that evening"), the patient experienced hives all over her body. On the telephone call was advised by her doctor to medicate with BENADRYL and EPSOM salt bath. On 12-DEC-2017, the patient called back and stated, that the hives were still on her face. She was advised to take CLARITIN or ZYRTEC. The patient was seen in the office on 13-DEC-2017 and the hives were gone, subsequently the event was considered as recovered. The patient stated that she did not take CLARITIN or cetirizine hydrochloride, but was continuing taking BENADRYL. No labs diagnostic were performed. The causality assessment was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, subcutaneously, lot # N008828, expiration date 16-MAR-2019 (dose was not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018. (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008779, 1712USA008780, 1712USA008781, 1712USA008782, 1712USA008783, 1712USA008784, 1712USA008785, 1712USA008786, 1712USA008787.); Sender's Comments: US-009507513-1712USA008779: US-009507513-1712USA008780: US-009507513-1712USA008781: US-009507513-1712USA008782: US-009507513-1712USA008783: US-009507513-1712USA008784: US-009507513-1712USA008785: US-009507513-1712USA008786: US-009507513-1712USA008787:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Impaired work ability, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was provided 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 26-SEP-2011 at a clinic, 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 23-AUG-2013, the patient was treated by a physician for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as herpes zoster, or shingles. The patient experienced symptoms so severe and persistent, she was forced to retire early from her employment due to her condition. 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. Herpes zoster/shingles and weakened immune symptoms were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Ophthalmic 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 27-MAR-2017(conflicting information), 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 27-JAN-2014 (conflicting information), the patient was treated by a physician for the onset of a blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. On or about 27-JAN-2017 (conflicting information), the patient was also treated for shingles that spread into her eyes, also called herpes zoster keratitis. The patient has been prescribed acyclovir and methylprednisolone (MEDROL packs) 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, pain and suffering, and other damages. Upon internal review the event of herpes zoster keratitis was determined to be medically significant. 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 registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, subcutaneously, lot # N008828, expiration date 16-MAR-2019 (dose was not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018. (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008050, 1712USA008780, 1712USA008781, 1712USA008782, 1712USA008783, 1712USA008784, 1712USA008785, 1712USA008786, 1712USA008787.); Sender's Comments: US-009507513-1712USA008050:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, subcutaneously, lot # N008828, expiration date 16-MAR-2019 (dose was not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018 (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008050, 1712USA008779, 1712USA008781, 1712USA008782, 1712USA008783, 1712USA008784, 1712USA008785, 1712USA008786, 1712USA008787). Sender's Comments: US-009507513-1712USA008050.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, subcutaneously, lot # N008828, expiration date 16-MAR-2019 (dose was not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018. (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008050, 1712USA008779, 1712USA008780, 1712USA008782, 1712USA008783, 1712USA008784, 1712USA008785, 1712USA008786, 1712USA008787.); Sender's Comments: US-009507513-1712USA008050:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX, subcutaneously, lot # N008828, expiration date 16-MAR-2019 (dose was not reported) for prophylaxis; administered along with a properly stored sterile diluent, subcutaneously, lot # L028663, expiration date 29-MAR-2018. (dose was not reported) for prophylaxis. It was reported that the vaccine was exposed to temperature of -9 degrees Celsius to 8 degrees Celsius, for a time frame of 4 hours and 4 minutes. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccines. No adverse effects were reported. There was no product quality complaint (PQC) involved. This is one of several reports received form the same reporter (MARRS # 1712USA008050, 1712USA008779, 1712USA008780, 1712USA008781, 1712USA008783, 1712USA008784, 1712USA008785, 1712USA008786, 1712USA008787.); Sender's Comments: US-009507513-1712USA008050:
Sex: F
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Rash vesicular
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding concomitant medications, concurrent conditions or medical history. On or about 28-DEC-2014, the patient was inoculated with ZOSTAVAX at a pharmacy as recommended for routine adult health maintenance and for the prevention of shingles (lot #, dose and route not provided). The vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of shingles.  Throughout April 2015, the patient was treated by a physician for the onset of blistery rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles.  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 unknown. Causality assessment was related.  Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Lymphadenitis, Lymphadenopathy, Pain, Skin warm
Clinical narrative: Lymphadenitis-swollen lymph nodes just below injection site on (R) arm. Mild erythema/warmth/pain.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse reaction in a 5-year-old male patient who received Flu vaccine Quadrivalent. On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Influenza vaccine Quadrivalent. Additional information was reported as follows: The age at vaccination was not reported. The patient had a reaction to the flu vaccine in 2015 (unknown manufacturer). This case has also been linked with case US2017189700, reported by the same reporter for the same patient.
Age: 0.75
Sex: F
Vaccine: DTAP, IPV, PNC13
Symptoms: Wrong drug administered
Clinical narrative: HIB ordered, HPV (GARDASIL) given in error.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Erythema, Headache, Myalgia, Pain
Clinical narrative: Sore, itching, redness, lump swelling, headache joint/muscle aches.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Swelling
Clinical narrative: Sore, itching, redness, lump swelling, headache joint/muscle aches.
Age: 70.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Fatigue, Headache, Hyperhidrosis, Hypersensitivity, Influenza like illness
Clinical narrative: Had all the described symptoms in literature (sore arm, swelling, headache, flu-like symptoms continued for 2 1/2  weeks (body aches, sinus congestion, sweating, fatigue, (fever?), then receded to "just" chronic left arm pain (pain waking me at night), limited arm movement, can't reach behind back or lift up without pain. Continues still to this day, 12-14-17. On a follow-up visit with Dr. (date unknown: a few months later), I complained of the prolonged symptoms following PREVNAR-13 shot and continuing arm pain awakening me in middle of night. She said I probably had an allergic reaction to the tetanus serum in Tdap and shouldn't have that shot in future. I've had at least 2 tetanus shots in my life and never had adverse reaction. For arm pain she ordered x-ray which I wasn't allowed to see but was told it was arthritis and to take ALEVE or other NSAID and most recent visit to take melatonin 10 mg to help with sleep. None of this is helping the arm pain which I believe is caused by taking a PREVNAR-13 injection to prevent pneumonia, which at this time I would rather take my chances with pneumonia than live with chronic shoulder pain/insomnia. Side note: at time I was given injection, the nurse (don't remember name) said at first try at arm jab, the needle tip "broke", so started over, but can't be related to serum side effects, right? It's now almost 1 1/2 years since I made the big mistake of agreeing to be an old guinea pig for a supposedly "safe" vaccine. Will I receive an acknowledgement of receipt of this form?
Age: 70.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injected limb mobility decreased, Osteoarthritis, Pain, Pain in extremity, Sinus congestion
Clinical narrative: Had all the described symptoms in literature (sore arm, swelling, headache, flu-like symptoms continued for 2 1/2  weeks (body aches, sinus congestion, sweating, fatigue, (fever?), then receded to "just" chronic left arm pain (pain waking me at night), limited arm movement, can't reach behind back or lift up without pain. Continues still to this day, 12-14-17. On a follow-up visit with Dr. (date unknown: a few months later), I complained of the prolonged symptoms following PREVNAR-13 shot and continuing arm pain awakening me in middle of night. She said I probably had an allergic reaction to the tetanus serum in Tdap and shouldn't have that shot in future. I've had at least 2 tetanus shots in my life and never had adverse reaction. For arm pain she ordered x-ray which I wasn't allowed to see but was told it was arthritis and to take ALEVE or other NSAID and most recent visit to take melatonin 10 mg to help with sleep. None of this is helping the arm pain which I believe is caused by taking a PREVNAR-13 injection to prevent pneumonia, which at this time I would rather take my chances with pneumonia than live with chronic shoulder pain/insomnia. Side note: at time I was given injection, the nurse (don't remember name) said at first try at arm jab, the needle tip "broke", so started over, but can't be related to serum side effects, right? It's now almost 1 1/2 years since I made the big mistake of agreeing to be an old guinea pig for a supposedly "safe" vaccine. Will I receive an acknowledgement of receipt of this form?
Age: 70.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Sleep disorder, Swelling, X-ray limb abnormal
Clinical narrative: Had all the described symptoms in literature (sore arm, swelling, headache, flu-like symptoms continued for 2 1/2  weeks (body aches, sinus congestion, sweating, fatigue, (fever?), then receded to "just" chronic left arm pain (pain waking me at night), limited arm movement, can't reach behind back or lift up without pain. Continues still to this day, 12-14-17. On a follow-up visit with Dr. (date unknown: a few months later), I complained of the prolonged symptoms following PREVNAR-13 shot and continuing arm pain awakening me in middle of night. She said I probably had an allergic reaction to the tetanus serum in Tdap and shouldn't have that shot in future. I've had at least 2 tetanus shots in my life and never had adverse reaction. For arm pain she ordered x-ray which I wasn't allowed to see but was told it was arthritis and to take ALEVE or other NSAID and most recent visit to take melatonin 10 mg to help with sleep. None of this is helping the arm pain which I believe is caused by taking a PREVNAR-13 injection to prevent pneumonia, which at this time I would rather take my chances with pneumonia than live with chronic shoulder pain/insomnia. Side note: at time I was given injection, the nurse (don't remember name) said at first try at arm jab, the needle tip "broke", so started over, but can't be related to serum side effects, right? It's now almost 1 1/2 years since I made the big mistake of agreeing to be an old guinea pig for a supposedly "safe" vaccine. Will I receive an acknowledgement of receipt of this form?
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Myalgia
Clinical narrative: Patient had her PREVNAR 13 injection November 11 and 2 days later she had myalgias and fatigue that lasted into the Thanksgiving time frame. Now her myalgias are intermittent and more in the hands and right shoulder.
Age: 31.0
Sex: F
Vaccine: FLUR3
Symptoms: Dizziness, Dysstasia, Headache
Clinical narrative: Dizziness for about 4 hrs after shot. Severe headache, saw primary care Dr and was prescribed Amitirx. Headache lasted about 2 weeks after shot. I was so dizzy I could not stand and the light affected my head and made headache worser.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site pain, Insomnia, Pain, Tenderness
Clinical narrative: Pain, large area, 10 cm of redness then tenderness. Now Rt arm/shoulder area is so painful she can't sleep. Saw an orthopedic who states the pain is most probably due to flu shot. Going to physical therapy.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Ultrasound scan normal, X-ray
Clinical narrative: Pain, large area, 10 cm of redness then tenderness. Now Rt arm/shoulder area is so painful she can't sleep. Saw an orthopedic who states the pain is most probably due to flu shot. Going to physical therapy.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Ear congestion, Erythema of eyelid, Ocular hyperaemia, Skin warm, Swelling
Clinical narrative: 3 inch long by 1 inch wide tapered raised welt, extremely hot and bright pink and swollen, appeared a day after my flu shot. It made my eyes reddish including lower lid edges, especially in my right shingles eye which I still treat daily w/drops and pills nearly a year after shingles onset last December 2016. My cheeks became swollen also, especially the left one (event inside my mouth) clear to the jaw line. Then my ears plugged up by 1 am, going into day 3. On 10-3-17, the arm mark was faded, warmer than surrounding skin and still tender to the touch. By 10-7-17, all my symptoms were finished.
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Swelling face, Tenderness, Urticaria
Clinical narrative: 3 inch long by 1 inch wide tapered raised welt, extremely hot and bright pink and swollen, appeared a day after my flu shot. It made my eyes reddish including lower lid edges, especially in my right shingles eye which I still treat daily w/drops and pills nearly a year after shingles onset last December 2016. My cheeks became swollen also, especially the left one (event inside my mouth) clear to the jaw line. Then my ears plugged up by 1 am, going into day 3. On 10-3-17, the arm mark was faded, warmer than surrounding skin and still tender to the touch. By 10-7-17, all my symptoms were finished.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Bone pain, Computerised tomogram, Dysstasia, Gait disturbance
Clinical narrative: Weakness pain deep in buttocks down legs-Pain in bones, muscles, scalding pain in skin-mostly legs- All over lethargy - Difficult walking/rising sitting-standing. No redness at INJ site of vaccine.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Lethargy, Musculoskeletal pain, Myalgia, Pain in extremity, Pain of skin
Clinical narrative: Weakness pain deep in buttocks down legs-Pain in bones, muscles, scalding pain in skin-mostly legs- All over lethargy - Difficult walking/rising sitting-standing. No redness at INJ site of vaccine.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Contusion, Feeling hot, Mobility decreased, Pain
Clinical narrative: Bruising, pain, warmth. Can't raise arm up. Advised to see MD.
Age: 49.0
Sex: F
Vaccine: MMR, TD, VARCEL
Symptoms: Peripheral swelling, Rash
Clinical narrative: Pat. stated she had swelling on (R) arm plus rash on both arms and partially on torso area.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Body temperature increased, Cold sweat, Decreased appetite, Diarrhoea, Diet refusal
Clinical narrative: That day patient was very tired, lethargic, and went to sleep. Over the course of that night and the next few days he had the common symptoms, I received notice of like runny nose, elevated temp at 99.5 via the forehead, clammy and sweaty, lack of appetite. Then it went from waiting out for the common symptoms to disappear to on day 8 he experienced nightmares waking up screaming, sensory overload, rubbing his eyes saying no no his head hurt like a headache, he also said boo boo in his legs as if he had joint paint he said his legs hurt. He also had mild diarrhea for 2-3 days, lack of appetite and refusing milk so we have been giving him water and juice. He is eating his meals. He also had itchy skin trying to rip off his clothes and trying to scratch his skin with no appearance of a rash at all.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Fatigue, Headache, Hyperhidrosis, Lethargy, Nightmare
Clinical narrative: That day patient was very tired, lethargic, and went to sleep. Over the course of that night and the next few days he had the common symptoms, I received notice of like runny nose, elevated temp at 99.5 via the forehead, clammy and sweaty, lack of appetite. Then it went from waiting out for the common symptoms to disappear to on day 8 he experienced nightmares waking up screaming, sensory overload, rubbing his eyes saying no no his head hurt like a headache, he also said boo boo in his legs as if he had joint paint he said his legs hurt. He also had mild diarrhea for 2-3 days, lack of appetite and refusing milk so we have been giving him water and juice. He is eating his meals. He also had itchy skin trying to rip off his clothes and trying to scratch his skin with no appearance of a rash at all.
Age: 2.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pain in extremity, Pruritus, Rhinorrhoea, Screaming, Sensory overload
Clinical narrative: That day patient was very tired, lethargic, and went to sleep. Over the course of that night and the next few days he had the common symptoms, I received notice of like runny nose, elevated temp at 99.5 via the forehead, clammy and sweaty, lack of appetite. Then it went from waiting out for the common symptoms to disappear to on day 8 he experienced nightmares waking up screaming, sensory overload, rubbing his eyes saying no no his head hurt like a headache, he also said boo boo in his legs as if he had joint paint he said his legs hurt. He also had mild diarrhea for 2-3 days, lack of appetite and refusing milk so we have been giving him water and juice. He is eating his meals. He also had itchy skin trying to rip off his clothes and trying to scratch his skin with no appearance of a rash at all.
Age: 33.0
Sex: M
Vaccine: FLUC4
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Limb injury
Clinical narrative: Patient was given a vaccine in deltoid area, reported it was too high in shoulder area, complaining of s/sx's that are consistent with Should Related Vaccine Injury, pain and limited mobility. The patient has scheduled an apt with his PCP, as the pain and mobility issues are becoming worsened at this time. The patient will continue to inform us of next steps and treatment at this time, however, a diagnosis confirming has not been made.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Product storage error
Clinical narrative: Vaccine was not viable due to refrigerator temperature had been below freezing for an extended period of time. Verified with manufacturer the vaccine was not viable.
Age: 63.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Product storage error
Clinical narrative: Patient did have some tenderness and redness at site.  Vaccine was not viable due to refrigerator temperature had been below freezing for an extended period of time. Verified with manufacturer the vaccine was not viable.
Age: 73.0
Sex: M
Vaccine: FLUC4, PNC13
Symptoms: Hypoaesthesia, Pain, Pruritus, Swelling, Swelling face
Clinical narrative: Patient said area was swollen, sore, itching, numb. Facial swelling.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Severe shoulder pain about 4 hrs after shot. 1 week later still in pain.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Mobility decreased
Clinical narrative: Patient states they cannot fully lift their arm if their palm is facing down. They have more range of motion with their palm up. Symptoms have lasted 2+ weeks.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Limb mass, Tenderness
Clinical narrative: Lump on left arm feels tender.
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: CSF culture negative, CSF glucose normal, CSF lymphocyte count increased, CSF monocyte count decreased, CSF protein normal
Clinical narrative: 2nd dose of MMR given on 11/30/2017. On 12/4/2017 complained of Headache and dizziness  (note received 1st dose of MMR on 11/1/2017 at a different facility).
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: CSF red blood cell count positive, CSF white blood cell count increased, Computerised tomogram head normal, Cytomegalovirus test negative, Dizziness
Clinical narrative: 2nd dose of MMR given on 11/30/2017. On 12/4/2017 complained of Headache and dizziness  (note received 1st dose of MMR on 11/1/2017 at a different facility).
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Epstein-Barr virus test negative, Full blood count normal, Gram stain, Haemoglobin normal, Headache
Clinical narrative: 2nd dose of MMR given on 11/30/2017. On 12/4/2017 complained of Headache and dizziness  (note received 1st dose of MMR on 11/1/2017 at a different facility).
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Herpes simplex test negative, Mean cell volume increased, Mumps antibody test negative, Neutrophil percentage increased, Varicella virus test negative
Clinical narrative: 2nd dose of MMR given on 11/30/2017. On 12/4/2017 complained of Headache and dizziness  (note received 1st dose of MMR on 11/1/2017 at a different facility).
Age: 32.0
Sex: F
Vaccine: MMR
Symptoms: Viral test negative
Clinical narrative: 2nd dose of MMR given on 11/30/2017. On 12/4/2017 complained of Headache and dizziness  (note received 1st dose of MMR on 11/1/2017 at a different facility).
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pain
Clinical narrative: No reaction when given. Next day patient presented with redness and soreness. Provider advised to wait and have PCP observe on next day. Seen PCP on 12/15 and diagnosed with cellulitis. Patient was due to have procedure and received second opinion and diagnosed as cellulitis. Prescribed Keflex. Pharmacist reviewed literature- suspect that it is a cellulitis-like reaction- doubtful that is is a secondary infection.
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Product storage error
Clinical narrative: Vaccine was not viable due to refrigerator temperature had been below freezing for an extended period of time. Verified with manufacturer the vaccine was not viable.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: PATIENT CALLED AND SAID SHE CANT LIFT HER HAND AND ITS SORE.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's medical history and concurrent conditions were not reported. The pharmacist reported that on an unknown date, the patient received an improperly stored dose of ZOSTAVAX lot # N020943 with expiration date 26-OCT-2018, or lot # N021170 with expiration date 27-OCT-2018 (also reported as 18-OCT-2018) (dosage and route of administration were not reported) for prophylaxis, which was exposed to a temperature of 6 Farenheit (F) to 14 F, for a time frame of 1 hour because of data logger. The vaccine had a previous temperature excursion of 6 F to 14 F for 19 hours and 30 minutes on an unknown date. A properly stored sterile diluent (manufacturer unknown) was used. No adverse effects reported.
Age: 65.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Dyspnoea
Clinical narrative: Dizziness, dyspnea.
Age: 1.83
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: No signs or symptoms. No reaction. A 3 and up flu was given to a 22 month old.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Vomiting
Clinical narrative: Patient experienced N/V after Influenza vaccination in Sept 2017. Patient did not have history of reaction to the Influenza vaccine. No further documentation provided.
Age: 58.0
Sex: M
Vaccine: HEPA, MMR, TDAP, TYP
Symptoms: Joint range of motion decreased, Joint swelling
Clinical narrative: 5 days after finishing oral typhoid vaccine client awoke with both knees swollen, it was difficult to bend or extend legs at knee. No pain. No Hx of similar jt pain. He may be developing arthritis.