chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of hives in a female patient who received FLULAVAL QUADRIVALENT. On an unknown date, the patient received FLULAVAL QUADRIVALENT at an unknown dose. On an unknown date, 1 hr after receiving FLULAVAL QUADRIVALENT, the patient experienced hives and pruritus. On an unknown date, the outcome of the hives and pruritus were recovered/resolved. The reporter considered the hives and pruritus to be probably related to FLULAVAL QUADRIVALENT. Additional details were provided as follows: The age at vaccination was not reported. In 2017, the patient received FLULAVAL QUADRIVALENT and experienced hives and pruritus. The reporter was asking if patient could receive HAVRIX despite this reaction to FLULAVAL. She did not have any product specific information or patient information (or much information about the adverse event). She stated that someone was filling out a VAERS.
Age: 0.67
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Urticarial lesions at bilateral axillae approx. 18 hours after influenza vaccine administered.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Respiratory rate decreased, Seizure, Urinary incontinence
Clinical narrative: Was notified around 1750 that an ambulance was called because patient started having convulsions. Mother called and reports that about 4 minutes after leaving the clinic patient started having convulsions, decreased respiratory rate, and had urinary incontinence. The mother called the ambulance and had patient was taken to hospital and is now in stable condition.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Nausea
Clinical narrative: Was notified at 1750 that patient started feeling nausea, dizzy, and weak after receiving vaccine and ambulance was called, the patients were in the back seat. Mother reports symptoms started about 4 minutes after leaving the clinic.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Diarrhoea, Insomnia
Clinical narrative: Diarrhea and trouble sleeping x 24 hours after imm. at 2 mo. No fever. 9-25-2017. 11-13-17 Parents agreed to 4 mo. imms.
Age: 45.0
Sex: M
Vaccine: FLUC4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Mentally disabled man and his sister came to pharmacy to get flu vaccine. All questions asked prior to admin. Administered vaccine and 20 min later his sister returned and said he received a flu shot 3 weeks prior (according to a different family member). No adverse rxn reported.
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Rash
Clinical narrative: Per patients mother the patient had redness in the arm. There was also a rash. Patient was not prescribed medication by provider.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: Swelling to the right arm. Swelling was 2 in x 2 in.
Age: 84.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dizziness, Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Patient experienced dizziness, pain and weakness in arm (L)/shoulder area within minutes after the vaccination. Pain in shoulder throughout night into next day, limited movement (Left shoulder).
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Cholecystectomy, Cholelithiasis, Herpes simplex, Herpes zoster, Incorrect route of drug administration
Clinical narrative: This spontaneous report was received from a 70 year old female patient reporting on herself. The patient's medical history included shingles; her current conditions included Asthma and unspecified thyroid issue; her concomitant medications included levothyroxine sodium (Manufacturer unknown), pravastatin, VENTOLIN and ADVAIR. The patient had not experienced any drug reactions or allergies. The patient reported that on 16-APR-2008, she was vaccinated with one dose of ZOSTAVAX intramuscular route of administration instead of subcutaneous administration (strenght, lot number and expiration date were not reported) for prevention of shingles. Other suspect therapy included sterile diluent injection (strength, lot number, expiration date were not reported). The patient informed that on 18-APR-2008, after receiving the vaccine, she developed an about 1.5 inches, hard, red, feverish circle and itching at the injection site. When she contacted the physician, the phsyician suggested her to to put ice on it. The patient further stated than since she was vaccinated with ZOSTAVAX, on an unspecified date in 2008, she had developed patches of herpes simplex 2, every year, at unspecified locations of her body. She confirmed that the physician prescribed an unspecified fungal cream and acyclovir. She also mentioned that she did get herpes zoster (shingles) at one point in time, but it was not clear if she experienced both, herpezoster outbreak in addition to herpes simplex 2 outbreaks at various points in time. The patient also stated that in 2013, she was admitted to the hosptial for about 3 days to have gallstones (cholelithiasis) and therefore gall bladder removed (Cholecystectomy). At the time of this report, the outcome of the 1.5 inches, hard, red, feverish circle and itching at the injection site, herpes simplex 2, herpes zoster (shingles) and gallstones; was reported as recovered on unknown dates. The causal relationship between the vaccination with ZOSTAVAX and the events was not reported. Upon internal review the event Cholelithiasis was determined to be medically significant as required Cholecystectomy.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report was received from a 70 year old female patient reporting on herself. The patient's medical history included shingles; her current conditions included Asthma and unspecified thyroid issue; her concomitant medications included levothyroxine sodium (Manufacturer unknown), pravastatin, VENTOLIN and ADVAIR. The patient had not experienced any drug reactions or allergies. The patient reported that on 16-APR-2008, she was vaccinated with one dose of ZOSTAVAX intramuscular route of administration instead of subcutaneous administration (strenght, lot number and expiration date were not reported) for prevention of shingles. Other suspect therapy included sterile diluent injection (strength, lot number, expiration date were not reported). The patient informed that on 18-APR-2008, after receiving the vaccine, she developed an about 1.5 inches, hard, red, feverish circle and itching at the injection site. When she contacted the physician, the phsyician suggested her to to put ice on it. The patient further stated than since she was vaccinated with ZOSTAVAX, on an unspecified date in 2008, she had developed patches of herpes simplex 2, every year, at unspecified locations of her body. She confirmed that the physician prescribed an unspecified fungal cream and acyclovir. She also mentioned that she did get herpes zoster (shingles) at one point in time, but it was not clear if she experienced both, herpezoster outbreak in addition to herpes simplex 2 outbreaks at various points in time. The patient also stated that in 2013, she was admitted to the hosptial for about 3 days to have gallstones (cholelithiasis) and therefore gall bladder removed (Cholecystectomy). At the time of this report, the outcome of the 1.5 inches, hard, red, feverish circle and itching at the injection site, herpes simplex 2, herpes zoster (shingles) and gallstones; was reported as recovered on unknown dates. The causal relationship between the vaccination with ZOSTAVAX and the events was not reported. Upon internal review the event Cholelithiasis was determined to be medically significant as required Cholecystectomy.
Age: 45.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Arthralgia, Chills, Fatigue, Feeling cold, Hyperhidrosis
Clinical narrative: Initial unsolicited case received from a nurse on 11 Oct 2017. This case involves 45-year-old male patient who was vaccinated with second dose of MENACTRA (Batch number: U5833AA, expiry date and dose were not reported) intramuscularly in right deltoid on 06 Oct 2017 at 12:35 PM. The patient medical history was reported as childhood asthma and no known allergies. The patient brother never had vaccines. The patient concomitant medication include first dose of FLUZONE (Batch number: UI850AA, expiry date not reported) intramuscularly in left deltoid on 26 Sep 2017. On 07 Oct 2017 at 03:00 AM, 2 hours and 25 minutes after the vaccination, the patient woke up and felt feverish, vomits and aching, cold, chills and sweaty and patient felt like skin was burning, did not assess temp, and patient took ibuprofen and went back to bed and on the same day at 08:00 AM, patient got up and he had no fever, no body aches and he rested until 10:00 AM, at the time patient felt achy again, he then took 800 mg ibuprofen and rested most of the day and night. On 08 Oct 2017 morning (AM), patient stated he was normal and started doing household works, and at midday, two days after the vaccination, patient again began feeling achy and fatigued, but by the evening of the same day, patient was feeling normal again. On 10 Oct 2017, four days after the vaccination, patient developed stiff neck and trapezius muscle felt tight and patient states that it cleaned up as the day went on and patient denies any other further complaints. Patient was previously vaccinated with dose one of MENACTRA (Batch number, expiry date, dose, route and site of administration were not reported) on 15 Jun 2012. Relevant lab tests were not reported. Other corrective treatment were not reported. On 07 Oct 2017, patient recovered from the event fever and on an unknown date, patient recovered from all the other events. List of documents held by sender: none.
Age: 45.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Muscle tightness, Musculoskeletal stiffness, Pyrexia, Skin burning sensation
Clinical narrative: Initial unsolicited case received from a nurse on 11 Oct 2017. This case involves 45-year-old male patient who was vaccinated with second dose of MENACTRA (Batch number: U5833AA, expiry date and dose were not reported) intramuscularly in right deltoid on 06 Oct 2017 at 12:35 PM. The patient medical history was reported as childhood asthma and no known allergies. The patient brother never had vaccines. The patient concomitant medication include first dose of FLUZONE (Batch number: UI850AA, expiry date not reported) intramuscularly in left deltoid on 26 Sep 2017. On 07 Oct 2017 at 03:00 AM, 2 hours and 25 minutes after the vaccination, the patient woke up and felt feverish, vomits and aching, cold, chills and sweaty and patient felt like skin was burning, did not assess temp, and patient took ibuprofen and went back to bed and on the same day at 08:00 AM, patient got up and he had no fever, no body aches and he rested until 10:00 AM, at the time patient felt achy again, he then took 800 mg ibuprofen and rested most of the day and night. On 08 Oct 2017 morning (AM), patient stated he was normal and started doing household works, and at midday, two days after the vaccination, patient again began feeling achy and fatigued, but by the evening of the same day, patient was feeling normal again. On 10 Oct 2017, four days after the vaccination, patient developed stiff neck and trapezius muscle felt tight and patient states that it cleaned up as the day went on and patient denies any other further complaints. Patient was previously vaccinated with dose one of MENACTRA (Batch number, expiry date, dose, route and site of administration were not reported) on 15 Jun 2012. Relevant lab tests were not reported. Other corrective treatment were not reported. On 07 Oct 2017, patient recovered from the event fever and on an unknown date, patient recovered from all the other events. List of documents held by sender: none.
Age: 45.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Burning sensation, Chills, Fatigue, Feeling cold, Hyperhidrosis
Clinical narrative: Initial unsolicited case received from a nurse on 11 Oct 2017. This case involves 45-year-old male patient who was vaccinated with second dose of MENACTRA (Batch number: U5833AA, expiry date and dose were not reported) intramuscularly in right deltoid on 06 Oct 2017 at 12:35 PM. The patient medical history was reported as childhood asthma and no known allergies. The patient brother never had vaccines. The patient concomitant medication include first dose of FLUZONE (Batch number: UI850AA, expiry date not reported) intramuscularly in left deltoid on 26 Sep 2017. On 07 Oct 2017 at 03:00 AM, 2 hours and 25 minutes after the vaccination, the patient woke up and felt feverish, vomits and aching, cold, chills and sweaty and patient felt like skin was burning, did not assess temp, and patient took ibuprofen and went back to bed and on the same day at 08:00 AM, patient got up and he had no fever, no body aches and he rested until 10:00 AM, at the time patient felt achy again, he then took 800 mg ibuprofen and rested most of the day and night. On 08 Oct 2017 morning (AM), patient stated he was normal and started doing household works, and at midday, two days after the vaccination, patient again began feeling achy and fatigued, but by the evening of the same day, patient was feeling normal again. On 10 Oct 2017, four days after the vaccination, patient developed stiff neck and trapezius muscle felt tight and patient states that it cleaned up as the day went on and patient denies any other further complaints. Patient was previously vaccinated with dose one of MENACTRA (Batch number, expiry date, dose, route and site of administration were not reported) on 15 Jun 2012. Relevant lab tests were not reported. Other corrective treatment were not reported. On 07 Oct 2017, patient recovered from the event fever and on an unknown date, patient recovered from all the other events. List of documents held by sender: none.
Age: 45.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Muscle tightness, Musculoskeletal stiffness, Pain, Pyrexia, Vomiting
Clinical narrative: Initial unsolicited case received from a nurse on 11 Oct 2017. This case involves 45-year-old male patient who was vaccinated with second dose of MENACTRA (Batch number: U5833AA, expiry date and dose were not reported) intramuscularly in right deltoid on 06 Oct 2017 at 12:35 PM. The patient medical history was reported as childhood asthma and no known allergies. The patient brother never had vaccines. The patient concomitant medication include first dose of FLUZONE (Batch number: UI850AA, expiry date not reported) intramuscularly in left deltoid on 26 Sep 2017. On 07 Oct 2017 at 03:00 AM, 2 hours and 25 minutes after the vaccination, the patient woke up and felt feverish, vomits and aching, cold, chills and sweaty and patient felt like skin was burning, did not assess temp, and patient took ibuprofen and went back to bed and on the same day at 08:00 AM, patient got up and he had no fever, no body aches and he rested until 10:00 AM, at the time patient felt achy again, he then took 800 mg ibuprofen and rested most of the day and night. On 08 Oct 2017 morning (AM), patient stated he was normal and started doing household works, and at midday, two days after the vaccination, patient again began feeling achy and fatigued, but by the evening of the same day, patient was feeling normal again. On 10 Oct 2017, four days after the vaccination, patient developed stiff neck and trapezius muscle felt tight and patient states that it cleaned up as the day went on and patient denies any other further complaints. Patient was previously vaccinated with dose one of MENACTRA (Batch number, expiry date, dose, route and site of administration were not reported) on 15 Jun 2012. Relevant lab tests were not reported. Other corrective treatment were not reported. On 07 Oct 2017, patient recovered from the event fever and on an unknown date, patient recovered from all the other events. List of documents held by sender: none.
Age: 7.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Erythema, Pharyngeal erythema, Pruritus, Rash, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of red throat in a 7-year-old-female patient who received FLULAVAL Quadrivalent (batch number 2F5Z4, expiry date 30th June 2018). On 1st November 2017, the patient received FLULAVAL Quadrivalent. On 6th November 2017, 5 days after receiving FLULAVAL Quadrivalent, the patient experienced red throat and urticaria. The patient was treated with BENADRYL (NOS). On an unknown date, the outcome of the red throat was unknown and the outcome of the urticaria was recovered/resolved. It was unknown if the reporter considered the red throat and urticaria to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: The nurse practitioner denied concomitant vaccines. The patient received  FLULAVAL Quadrivalent on Right deltoid. The reporting nurse practitioner stated that the patient's grandmother stated that symptoms in the patient started last night, these included urticaria and hives along patient's face, cheeks, and temporal area. The reporting nurse practitioner stated that symptoms disappeared 10 minutes after the patient was given BENADRYL, and that the grandmother gave BENADRYL to her last night as well. She stated that the patient's throat looked a little red, but other symptoms were denied.
Age: 7.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pharyngeal erythema, Urticaria
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of red throat in a 7-year-old-female patient who received FLULAVAL Quadrivalent (batch number 2F5Z4, expiry date 30th June 2018). On 1st November 2017, the patient received FLULAVAL Quadrivalent. On 6th November 2017, 5 days after receiving FLULAVAL Quadrivalent, the patient experienced red throat and urticaria. The patient was treated with BENADRYL (NOS). On an unknown date, the outcome of the red throat was unknown and the outcome of the urticaria was recovered/resolved. It was unknown if the reporter considered the red throat and urticaria to be related to FLULAVAL Quadrivalent. Additional details were provided as follows: The nurse practitioner denied concomitant vaccines. The patient received  FLULAVAL Quadrivalent on Right deltoid. The reporting nurse practitioner stated that the patient's grandmother stated that symptoms in the patient started last night, these included urticaria and hives along patient's face, cheeks, and temporal area. The reporting nurse practitioner stated that symptoms disappeared 10 minutes after the patient was given BENADRYL, and that the grandmother gave BENADRYL to her last night as well. She stated that the patient's throat looked a little red, but other symptoms were denied.
Age: 33.0
Sex: F
Vaccine: HEP, MMR, HEP, MMR
Symptoms: Accidental underdose, Drug administered to patient of inappropriate age, Pruritus generalised
Clinical narrative: Patient reported intense itching over her face and body. BENADRYL relieved itching.
Age: 33.0
Sex: F
Vaccine: HEP, MMR, HEP, MMR
Symptoms: Pruritus generalised
Clinical narrative: Patient reported intense itching over her face and body. BENADRYL relieved itching.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Injection site pain, Joint crepitation, Tenderness
Clinical narrative: Now at the three month mark, continual ache and soreness, popping sound upper left shoulder, cannot apply pressure to the arm during sleep, limited range of motion.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Infection, Pyrexia, Tremor
Clinical narrative: Patient had uncontrollable shaking and fever the day after being vaccinated. The patient was admitted to the ER 2 days later. The ER did confirm that patient had another infection going on which they were treated for, but the patient was concerned that since this happened so shortly after being vaccinated it could be related. They wanted to report it  in case any of the symptoms were not only related to the infection, but also the vaccination. Patient no longer is experiencing a fever and the symptoms of shaking have become minimal.
Sex: F
Vaccine: HPV9
Symptoms: Rash
Clinical narrative: Information was received from a physician via company representative and referred to a female patient of unspecified age. No information regarding the patient's pertinent medical history, drug reactions, allergies or concomitant medications was reported. On an unspecified date, the patient was vaccinated with GARDASIL 9 (intramuscularly; dose, lot# and expiration date were not reported). On an unspecified date, the patient developed rash on insertion arm. The patient went to doctor office. No relevant laboratory tests were performed. No treatment was given. The reporter stated the rash was resolved. Causality assessment was not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative and refers to a male patient of an unknown age. No information on the patient's concurrent conditions, medical history and concomitant medications was reported. In approximately 2015 (reported as 2 years ago), the patient in his 60s, was vaccinated with a dose of ZOSTAVAX vial 19400 PFU (dose, route of administration, lot # and expiry date were not reported) for prophylaxis, at the pharmacy. Other suspect therapy included sterile diluent (manufacturer unknown). In approximately August 2017 (reported as 2 months ago), the patient experienced shingles. The pharmacist reported that patient was advised to see a physician. The pharmacist reported that on an unspecified date, the patient was examined by an unspecified physician, who treated the patient with an unspecified dose of VALTREX. No laboratory diagnostic studies were performed. The outcome of the event was recovered, in approximately 2017. The reporter did not assess relatedness between the event and vaccination with ZOSTAVAX and sterile diluent (manufacturer unknown).
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a patient's friend refers to his 27 year old female friend. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On unknown date in 2017 at the age of 27 years old, the patient began GARDASIL 9 series (first and second dose administered on day 0 and 2 months respectively) (dose, lot #, expiration date and route were not reported). No adverse reaction reported. For the third dose of GARDASIL 9, the patient was schedule for an appointment "next month" which has been more than a 6 month interval from the time she received the second dose and the patient was a bit concerned for this timeframe.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, pertinent medical history and concomitant therapies were not reported. On an unknown date, the patient was inadvertently vaccinated with a dose of VAQTA (dose, lot #, expiration date and route were not reported) for prophylaxis; when the patient should have received RECOMBIVAX HB. No adverse symptoms reported.
Sex: M
Vaccine: MMR
Symptoms: Pyrexia
Clinical narrative: This spontaneous report was received from a patient's mother and refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On an unknown date in approximately 2017 (reported as recently), the patient was vaccinated with M-M-R II injection (route, anatomical location, lot# and expiration date were not reported) for prophylaxis. On an unknown date in approximately 2017 (reported as after receiving the injection), the patient had a fever. The outcome of the event and the causality between the event and M-M-R II were not reported.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a 25 year old female patient. The patient pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On an unknown date in 2007, the patient was vaccinated with the first dose of GARDASIL (strength, dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included GARDASIL 9 (strength, dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. The reporter stated that patient received the first dose GARDASIL when she was 15 years old. Per physician, the patient, who was now 25 years old, was in the office to receive the second dose for human papilloma virus (HPV); however, the formulation that is available was GARDASIL 9. No adverse effects reported.
Sex: U
Vaccine: HEP, HPV9, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a physician referring to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On unknown dates in 2017, between 01-SEP-2017 and 25-OCT-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally (strength, dose, lot # and expiration date were not reported) for prophylaxis. Other suspect therapies included GARDASIL 9 (strength, dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis; and RECOMBIVAX HB (strength, dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. No adverse effects were reported. The temperature excursion occurred between 47° F and 77° F and 32° F and 35° F, for an unknown amount of time. The temperature excursion was call because of a data logger. No previous temperature excursion occurred before.
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Information has been received from an office manager via a company representative concerning to an under 2 year old patient (gender not reported) who on an unknown date was vaccinated with a dose of PNEUMOVAX 23 (route, lot number and expiration date not reported) for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: Information has been received from a certified medical assistant reporting on a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On 06-NOV-2017, the patient received an improperly stored dose of M-M-R II for prophylaxis, lot # N013867, expiration date 04-MAY-2019 (strength, dose, anatomical location and route of administration were not reported). The vaccine was reconstituted with properly stored sterile diluent lot # N026990, expiration date 26-SEP-2018. No adverse effect reported. It was reported that on an unspecified date, the vaccine was exposed to a temperature between 9 degrees Celsius and 25 degrees Celsius for 1 hour and 5 minutes. The certified medical assistant reported that there was no previous temperature excursion. The call was placed because of a Digital Data logger report.
Sex: M
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, Rheumatoid arthritis
Clinical narrative: This spontaneous report was received from a nurse referring to a 61 year old male. The patient's medical history and concomitant medications were not reported. On 10-OCT-2017 the patient was vaccinated with a first dose of M-M-R II (lot # M048368, expiration date: 08-DEC-2018, strength, dosage and schedule were not reported) together with a sterile diluent (MERCK STERILE DILUENT) (lot# and date of expiration was not reported) subcutaneous for prophylaxis. Subsequently, on 07-NOV-2017 patient received a second dose of the same vaccine. It was reported that the patient had been taking an unspecified dose of etanercept (ENBREL) for rheumatoid arthritis. The causal relationship between M-M-R II together with a sterile diluent (MERCK STERILE DILUENT) and rheumatoid arthritis was not provided. Upon internal review rheumatoid arthritis was determined to be a medically significant event.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness, Pain
Clinical narrative: Information has been received from a nurse practitioner referring to a 60 years old male patient. The patient had no pre-existing physician-diagnosed allergies, birth defects or medical conditions and no illness at time of vaccination. The patient (or his brother) had no adverse event following a prior vaccination. The patient had no other vaccinations within 4 weeks prior to 07-NOV-2017 was received. Concomitant therapies included omega-3 marine triglycerides (reported as fish oil) and vitamins (unspecified). On 07-NOV-2017 about 15:00, the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose was not provided, lot # M026317, expiration date not provided, system auto-generated as 11-JAN-2018) intramuscularly in the left deltoid for prophylaxis. The vaccination was given at the patient's employer. On 07-NOV-2017 18:00, the patient felt pain in upper arm and shoulder. The reported arm felt very stiff and he was having difficulty moving it. The patient stated "it feels like my rotator cuff surgery" and "I couldn't sleep". The patient was having 8 out of 10 level pain while moving his arm and his arm didn't hurt when it was not moving. The patient's injection site area looked fine. The events were resolved in 48 hours (approximately on 09-NOV-2017) with ice/heat and ADVIL which was an over-the-counter drug (OTC). No prescription drug treatment for the experience was required. The patient sought medical attention via contacting nurse practitioner. The causality was not provided. No product quality complaint (PQC) was involved.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Information has been received from a nurse practitioner referring to a 60 years old male patient. The patient had no pre-existing physician-diagnosed allergies, birth defects or medical conditions and no illness at time of vaccination. The patient (or his brother) had no adverse event following a prior vaccination. The patient had no other vaccinations within 4 weeks prior to 07-NOV-2017 was received. Concomitant therapies included omega-3 marine triglycerides (reported as fish oil) and vitamins (unspecified). On 07-NOV-2017 about 15:00, the patient was vaccinated with the first dose of PNEUMOVAX 23 (dose was not provided, lot # M026317, expiration date not provided, system auto-generated as 11-JAN-2018) intramuscularly in the left deltoid for prophylaxis. The vaccination was given at the patient's employer. On 07-NOV-2017 18:00, the patient felt pain in upper arm and shoulder. The reported arm felt very stiff and he was having difficulty moving it. The patient stated "it feels like my rotator cuff surgery" and "I couldn't sleep". The patient was having 8 out of 10 level pain while moving his arm and his arm didn't hurt when it was not moving. The patient's injection site area looked fine. The events were resolved in 48 hours (approximately on 09-NOV-2017) with ice/heat and ADVIL which was an over-the-counter drug (OTC). No prescription drug treatment for the experience was required. The patient sought medical attention via contacting nurse practitioner. The causality was not provided. No product quality complaint (PQC) was involved.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a physician referring to a patient of unknown age and gender.  Information about concurrent condition, concomitant medication and medical history was not provided. On 27-OCT-2017 the patient was vaccinated with expired dose of PNEUMOVAX 23 (lot # M013156, expiration date 15-OCT-2017) (dose and route were not reported) for prophylaxis (expired product administered). No adverse effects were reported.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Chills, Headache, Influenza virus test negative, Myalgia, Neck pain
Clinical narrative: Symptoms began midafternoon on 11/13/2017. They were muscle/neck pain, achy and chills all day and headache. Fever 101.2 at visit next day.
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Pain, Pyrexia
Clinical narrative: Symptoms began midafternoon on 11/13/2017. They were muscle/neck pain, achy and chills all day and headache. Fever 101.2 at visit next day.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Chills, Fatigue, Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: I received both a flu vaccination and a pneumonia vaccination on Friday afternoon. On Saturday evening my neck became sore and I began to develop a headache in what felt like the back of my head. By midnight I was in a lot of pain, very stiff neck and severe headache. Thought I'd try to sleep it off and went to bed. My body starting shivering to the point my teeth were clattering. Eventually fell asleep but was awakened multiple times from the neck pain and headache. By 8:00 AM when I awoke for the day, the stiffness and headache had subsided, but I was left exhausted. I felt mostly recovered by early Sunday evening and fully recovered by Monday morning.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Sleep disorder
Clinical narrative: I received both a flu vaccination and a pneumonia vaccination on Friday afternoon. On Saturday evening my neck became sore and I began to develop a headache in what felt like the back of my head. By midnight I was in a lot of pain, very stiff neck and severe headache. Thought I'd try to sleep it off and went to bed. My body starting shivering to the point my teeth were clattering. Eventually fell asleep but was awakened multiple times from the neck pain and headache. By 8:00 AM when I awoke for the day, the stiffness and headache had subsided, but I was left exhausted. I felt mostly recovered by early Sunday evening and fully recovered by Monday morning.
Age: 69.0
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Body temperature increased, Feeling cold, Hyperhidrosis, Tremor
Clinical narrative: Was given the PREVNAR 13 and influenza vaccines at the same time. Four hours later, became very cold and started shaking violently. At six hours had a temperature of 102.3. Took additional 6 hours to get temperature down to normal range. In meantime was sweating profusely and went through 3 changes of clothes and bedding. Possibly adverse reaction to administering both vaccines at the same time. Had no problem when either were administered singly. I see that this is a known adverse reaction in children and wanted to report it so you know it happens in adults as well.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness, Nausea
Clinical narrative: Patient received a HD flu vaccine and experienced dizziness, unsteadiness, nausea, and felt faint for 3-4 days afterwards.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Back pain, Condition aggravated, Discomfort, Joint stiffness
Clinical narrative: I suffer from chronic low back pain. After recovering the flu shot, my back started stiffening. I have pulsating stabbing pain on left side of my lower back that radiates to my left hip and down to my leg. My back feels heavy and the pain seems to be different than what it usually is. It's day 5 since I received it, and my knees are starting to get stiff, plus my feet are getting tingling sensations.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Pain in extremity, Paraesthesia
Clinical narrative: I suffer from chronic low back pain. After recovering the flu shot, my back started stiffening. I have pulsating stabbing pain on left side of my lower back that radiates to my left hip and down to my leg. My back feels heavy and the pain seems to be different than what it usually is. It's day 5 since I received it, and my knees are starting to get stiff, plus my feet are getting tingling sensations.
Age: 14.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Family came from the exam room to check out. While checking out the patient passed out and hit her head on the wall.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient called on 7/31/17 and reported a problem with her right shoulder, arm and hand after getting a TDap vaccine injection on 7/25/17. She said she had pain in her right shoulder she used ice, heat and was taking TYLENOL. She said she started having trouble picking up items like her cell phone. She said she is having difficulty turning at the wrist or moving her wrist from side to side. She said the pain radiates up to the shoulder. She again said this all began after the injection. Patient was seen again on 8/16/17 and presented with no complaints. Patient was a G2P2 with an EDD of 10/20/17.
Age: 1.33
Sex: M
Vaccine: FLU4
Symptoms: Culture throat negative, Erythema multiforme, Generalised erythema, Rash, Skin lesion
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of erythema multiforme in a 16-month-old male patient who received FLULAVAL Quadrivalent (batch number 354H9, expiry date 30th June 2018). On 31st October 2017, the patient received the 1st dose of FLULAVAL Quadrivalent .5 ml. On 2nd November 2017, 2 days after receiving FLULAVAL Quadrivalent, the patient experienced erythema multiforme (serious criteria GSK medically significant), rash and skin lesion. On an unknown date, the patient experienced generalized erythema. The patient was treated with ZYRTEC and prednisolone. On an unknown date, the outcome of the erythema multiforme, rash, generalized erythema and skin lesion were unknown. It was unknown if the reporter considered the erythema multiforme, rash, generalized erythema and skin lesion to be related to FLULAVAL Quadrivalent. Additional details were reported as follows: At 04:00, the patient received FLULAVAL Quadrivalent. On 2nd November 2017, Thursday, the patient experienced rash. The physician diagnosed it as erythema multiforme. The patient was seen in the office on Friday as the rash had progressed. The reporter read the notes from the physician assistant who observed the patient and the notes included the sporadic erythematous raised circular lesions 1 by 1 cm on body. There was no central clearing, vesicles, crusting. A throat culture was taken which resulted negative.
Sex: U
Vaccine: HEP, HEPA, HPV9, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a nurse who referred to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient might have been vaccinated with improperly stored doses of VAQTA (lot # N005605, expiration date 08-APR-2018; lot# N016805, expiration date 04-SEP-2018; lot # N020503, expiration date 04-SEPT-2018; lot # N012324, expiration date 05-APR-2018; lot # N019924, expiration date 02-SEP-2018, lot # N014945, expiration date 31-AUG-2018; lot # N017094, expiration date 31-SEP-2018), RECOMBIVAX HB (lot # N002920, expiration date 30-SEP-2018; lot # M044032, expiration date 03-JUL-2019; lot # 20613, expiration date 05-MAY-2020), GARDASIL 9 (lot # N014470, expiration date 17-JUN-2019; lot # N017697, expiration date 21-JAN-2020), PNEUMOVAX 23 (lot # N014188, expiration date 22-JAN-2019; lot # N005096, expiration date 22-OCT-2018) or ROTATEQ lot # N004814, expiration date 21-OCT-2018; lot # N004946, expiration date 05-OCT-2018 or M043838, expiration date 18-JUN-2018 for prophylaxis. The nurse was unsure which lot # the patient received. There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion from 32 degrees Fahrenheit to 35 degrees Fahrenheit for 20 hours and 45 minutes. Data logger was involved. There were no previous excursions reported.
Sex: U
Vaccine: PPV
Symptoms: 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 concurrent conditions, concomitant medication and medical history were unknown. On 18-OCT-2017, the patient was vaccinated with PNEUMOVAX 23 lot # N000508, expiration date 19-OCT-2018 for prophylaxis (dosage and route of administration were not reported). Other suspect therapies included PREVNAR 13. According to the reporter, the patient's vaccination history was unknown and was unclear if the patient received a prior dose of PNEUMOVAX 23 or PREVNAR 13. No adverse effects were reported.
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous, non-valid report was received from a nurse and concerning unspecified patients of unknown age and gender. The patients' medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with improperly doses of: VARIVAX lot number N019822, expiration date: 13-JUL-2019 or lot number N019131, expiration date: 22-JUN-2019 or lot number N012619, expiration date: 21-APR-2019 or lot number N012131, expiration date: 17-APR-2017, for prophylaxis (dose and route of administration were not reported) or ZOSTAVAX, lot/batch number, reported as "N009643", expiration date: 17-MAR-2018, for prophylaxis (dose and route of administration were not reported). Concomitant therapies included sterile diluent (MERCK) which did not undergo a temperature excursion. The vaccines underwent a temperature excursion between 6 to 14 (also reported as "13.3") Fahrenheit degrees for 245 minutes. The previous temperature excursion were between 6 to 14 Fahrenheit degrees for 115 minutes and between 15 to 46 (also reported as "19") Fahrenheit degrees for 35 minutes. Digital data logger was involved in recording the excursion. No adverse effects were reported.
Age: 66.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Contraindication to vaccination, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 66 year old male patient. The patient's pertinent medical condition included psoriasis treated with ENBREL. The patient was considered to be immunocompromised. The patient was also taking other unspecified concomitant medications. Drug allergies were not provided. On 18-OCT-2017, the patient was vaccinated with ZOSTAVAX, 0.65 ml in the right arm, expiration date 27-OCT-2018 (route of administration was not provided) for prophylaxis. Lot number M021170 is an invalid lot number for ZOSTAVAX. Concomitant therapies included ENBREL, influenza virus vaccine (unspecified) (administered on the same day 18-OCT-2017, reported as "flu shot") and sterile diluent (MERCK). The patient experienced no adverse events.
Sex: M
Vaccine: PPV
Symptoms: Atrial fibrillation, Palpitations
Clinical narrative: This initial spontaneous report was received on 16-NOV-2017 from a 78 year old male patient referring to himself. Medical history included two stents placed in December 2014. Since then, he has taken LIPITOR and AZOR regularly. Until 12-OCT-2017, his blood pressure and heart rate were under control. On that date, the patient was vaccinated with PNEUMOVAX 23 (dose, route and lot # not provided) at his physician's office. Just prior to the injection, his blood pressure was 120/70 and his heart rate was 70. By 1:00 pm, he could feel his heart racing. He went to the local Emergency Room (ER) at which time his heart rate was up to 150. The doctors diagnosed him with atrial fibrillation. The patient was treated with metoprolol and after a night's stay, his heart rate returned to 70. His medications now include metoprolol abd "the very expensive" ELIQUIS. He stated he never had an atrial fibrillation problem before. The patient believes he had an allergic reaction to PNEUMOVAX 23. His cardiologist said the reaction was very possible in someone with a preexisting condition. The patient feels the safety information provided on the company's website does not adequately warn patients of the risks. He stated that for those with cardiovascular problems, while the benefit from the vaccine may protect against pneumonia, the risk is death from an out-of-control heart. The patent feels he is entitled to compensation for the life-threatening event. The outcome of the events was recovered. Causality assessment was related. Upon internal review, atrial fibrillation was considered medically significant. The patient considered the atrial fibrillation and allergic reaction to PNEUMOVAX 23 to be life threatening. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Balance disorder, Dizziness
Clinical narrative: Initial unsolicited case received from a consumer (patient) on 11 Oct 2017. This case involves an 80-year-old male patient who was vaccinated with 0.5 ml one dose of FLUZONE HIGH-DOSE (Batch number, expiry date, dose in series and site of administration were not reported) intramuscularly on 07 Oct 2017. Patient medical history was reported as Tinnitus diagnosed in 2011. The patient previously received a dose of FLUVIRIN on an unknown date last year and he felt fine. Concomitant medications were not reported. On 07 Oct 2017, about one hour after the vaccination, patient started with feeling lightheaded slightly dizzy and off balance. It was reported as patient required an ER visit and he was seeing a doctor. Relevant lab tests were not reported. As a corrective treatment patient received Meclizine. Outcome of the both the events were not recovered. List of documents held by sender: none.