chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified number of patients with unknown age and gender. There was no information about the patient's medical history and concurrent condition. On unknown date, the patients were vaccinated with improperly stored PNEUMOVAX 23 (dose, lot# and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified numbers of patients with unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (dose, lot# and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to unspecified numbers of patients with unknown age and gender. There was no information about the patients' medical history and concurrent condition. On unknown dates, the patients were vaccinated with improperly stored GARDASIL 9 (dose, lot# and route unknown). There was no information about concomitant therapy. No adverse effects were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a male patient of unknown age. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 04-DEC-2015, the patient was vaccinated with ZOSTAVAX, (lot#, expiry date, dose, frequency and route of administration not reported). On 07-DEC-2015 (also reported as today), the patient telephoned to say that he was unsure if he has had the ZOSTAVAX vaccine before 04-DEC-2015. No adverse effects reported. No product quality complaint (PQC) was involved. No further information was reported. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Pain
Clinical narrative: Patient received a PREVNAR 13 vaccine on 12-9-2015. Patient returned 12-14-15 stating possible reaction. Pt c/o difficulty walking and body ache.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Cold sweat, Heart rate increased, Hypertension
Clinical narrative: I took PREVNAR 13 inj. 0.5ml on 12/15/2015. I experienced, increased heart rate and higher blood pressure, extreme COLD SWEATS all night long even when house temp was 62F. This was after taking 2 Advils 250 mg each.
Age: 12.0
Sex: M
Vaccine: MENB, TDAP
Symptoms: Computerised tomogram head normal, Hemiparesis, Laboratory test normal, Petit mal epilepsy, VIIth nerve paralysis
Clinical narrative: Right sided heaviness and left facial droop that was transient.  Patient had no further symptoms until 12/16/2015 at 10:38 PM when he was found to be having a probable absence seizure.  He was again seen in the ED and CT scan of head was normal. He has no previous history of seizures.
Age: 1.05
Sex: M
Vaccine: DTAP, FLU4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Erythema, Pruritus, Rash, Skin lesion
Clinical narrative: Rash - noted in the AM as dozens of discrete erythematous lesions, then spread/consolidated diffusely.  This evolved over the next days.  Lesions were stable and somewhat pruritic.  None vesicular. As of today (12/17), it is slowly resolving.
Age: 83.0
Sex: F
Vaccine: FLUX(H1N1)
Symptoms: Bone pain, Injection site pain, Poor quality sleep, Rotator cuff syndrome
Clinical narrative: Arm where vaccine given began to ache deeply and prevents comfortable sleep. It is ongoing. Diagnoses: nicking of bone from vaccination; rotator cuff; mercury in vaccine causing bone pain.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema
Clinical narrative: (L) thigh w/erythema 3cm to (L) of injection site.
Age: 41.0
Sex: F
Vaccine: FLUX
Symptoms: Epistaxis
Clinical narrative: Heavy nose bleed, with no history of getting nose bleeds.
Age: 1.03
Sex: M
Vaccine: HEPA, MMR, VARCEL, VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Given varicella, Hepatitis A, and MMR vaccines as 1 year immunizations.  Zostavax was given also.
Sex: U
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative, No therapeutic response
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of adult patients. No information regarding the patients' pertinent medical history, concomitant medication and drug reaction or allergies was reported. On unknown dates, the patients were vaccinated with the complete three-dose series of RECOMBIVAX HB (strength, dose, route of administration, lot # and expiration date were not provided). On unknown dates (also reported as "over the years"), the patients were nonresponders (did not have detectable antibody levels). The outcome of the event was not reported. The relatedness between the events and RECOMBIVAX HB was not reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 1.1
Sex: F
Vaccine: FLU4
Symptoms: Chills, Feeling of body temperature change, Lip discolouration, Rash generalised
Clinical narrative: Woke up from nap, per babysitter she was hot then cold quickly, was shivering, had a transient rash all over body and lips got dark. Daycare lady picked her up and was fine symptoms resolved within 5 minutes, little fussier than normal.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Incorrect route of drug administration
Clinical narrative: Subcutaneous immunization given intramuscularly.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Dyspnoea, Fibromyalgia, Hypoaesthesia, Myalgia
Clinical narrative: Hard to breathe as throat swelled up so much it was hard to get air inhaled and exhaled. Numbness in left arm and chest. It resembled a heart attack. Extreme muscle, joint and nerve pain. Has had the intense muscle, joint and nerve pain constantly after the flu shot.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Neuralgia, Pharyngeal oedema
Clinical narrative: Hard to breathe as throat swelled up so much it was hard to get air inhaled and exhaled. Numbness in left arm and chest. It resembled a heart attack. Extreme muscle, joint and nerve pain. Has had the intense muscle, joint and nerve pain constantly after the flu shot.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Abdominal pain, Activities of daily living impaired, Erythema multiforme, Pruritus, Pyrexia
Clinical narrative: Initial solicited report received on 17 April 2015 and follow up information received on 17 April 2015 from an investigator participating in a study.  A 10-year-old male subject was diagnosed with atypical erythema multiforme on 04 March 2015 i.e. 84 days after receiving a first dose of study vaccine MENVEO on 10 December 2014 (site of administration, route of administration and batch number was not reported).  The event appeared after visit 2. The subject had no relevant medical history. The subject had concomitant therapies with dose 1 ADVIL 2 tablets orally for abdominal pain on 01 March 2015 and "1" PAIN-AID orally for fever on 02 March 2015. The cause of erythema multiforme minor was unknown. The subject was hospitalized on 07 March 2015. There were no lab investigations performed. The subject was treated with Anti-itch medicine, cold compresses and BENADRYL PRN. The subject was discharged from the hospital on 08 March 2015. The event of atypical erythema multiforme was resolved on 30 March 2015. According to the investigator, the event was not related to the concomitant medications. According to the investigator, the event was not related to the study vaccine or to the trial procedures. Relationship to investigational product according to Company: not associated. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Follow up information received on 28 April 2015: It was reported that on 01 March 2015 subject had complaining of abdominal pain, he took two ADVIL and symptoms resolved. The next day the subject was sent home from school with fever of 101.0 for which he took PAIN-AID, and the fever resolved. On 03 March 2015 subject complained minor abdominal pain, but it resolved on its own. No further fever or abdominal pain for 48 hours. On 04 March 2015 subject woke up with a rash on his upper thighs and by last night it had spread down his legs. The subject mother gave him 2 BENADRYL. On 05 March 2015 rash spread to rest of his body. Itch was minor but not painful with contact. On 06 March 2015 subject was admitted to hospital for worsening rash with fever and vomiting. As a corrective treatment the subject received two capsule of Diphenhydramine orally every 6 hourly for itching. Follow up information received on 08 May 2015. The PAIN-AID concomitant medication were updated as subject received Aspirin tablet of 162 mg, PARACETAMOL 110 mg and 32.4 g of caffeine. Follow up information received on 14 May 2015 and 15 May 2015: The investigator reported that there was no skin biopsy performed and also there were no lesions. It was reported that investigations for infectious etiology were performed. Follow up information received on 6 June 2015 (PV query): The investigator confirmed that the subject was seen by a dermatologist however infectious etiology was not performed.
Age: 10.0
Sex: M
Vaccine: MNQ
Symptoms: Rash generalised, Vomiting
Clinical narrative: Initial solicited report received on 17 April 2015 and follow up information received on 17 April 2015 from an investigator participating in a study.  A 10-year-old male subject was diagnosed with atypical erythema multiforme on 04 March 2015 i.e. 84 days after receiving a first dose of study vaccine MENVEO on 10 December 2014 (site of administration, route of administration and batch number was not reported).  The event appeared after visit 2. The subject had no relevant medical history. The subject had concomitant therapies with dose 1 ADVIL 2 tablets orally for abdominal pain on 01 March 2015 and "1" PAIN-AID orally for fever on 02 March 2015. The cause of erythema multiforme minor was unknown. The subject was hospitalized on 07 March 2015. There were no lab investigations performed. The subject was treated with Anti-itch medicine, cold compresses and BENADRYL PRN. The subject was discharged from the hospital on 08 March 2015. The event of atypical erythema multiforme was resolved on 30 March 2015. According to the investigator, the event was not related to the concomitant medications. According to the investigator, the event was not related to the study vaccine or to the trial procedures. Relationship to investigational product according to Company: not associated. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Follow up information received on 28 April 2015: It was reported that on 01 March 2015 subject had complaining of abdominal pain, he took two ADVIL and symptoms resolved. The next day the subject was sent home from school with fever of 101.0 for which he took PAIN-AID, and the fever resolved. On 03 March 2015 subject complained minor abdominal pain, but it resolved on its own. No further fever or abdominal pain for 48 hours. On 04 March 2015 subject woke up with a rash on his upper thighs and by last night it had spread down his legs. The subject mother gave him 2 BENADRYL. On 05 March 2015 rash spread to rest of his body. Itch was minor but not painful with contact. On 06 March 2015 subject was admitted to hospital for worsening rash with fever and vomiting. As a corrective treatment the subject received two capsule of Diphenhydramine orally every 6 hourly for itching. Follow up information received on 08 May 2015. The PAIN-AID concomitant medication were updated as subject received Aspirin tablet of 162 mg, PARACETAMOL 110 mg and 32.4 g of caffeine. Follow up information received on 14 May 2015 and 15 May 2015: The investigator reported that there was no skin biopsy performed and also there were no lesions. It was reported that investigations for infectious etiology were performed. Follow up information received on 6 June 2015 (PV query): The investigator confirmed that the subject was seen by a dermatologist however infectious etiology was not performed.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Abnormal behaviour, Aggression, Appetite disorder
Clinical narrative: Initial solicited report received on 22 July 2015 and follow-up information received on 28 July 2015 from an investigator participating in a trial. This case involves a 12-year-old male subject who developed behavioral problems during the study participation. The subject had a medical history of autism spectrum disorder, mood disorder and attention deficit-hyperactivity disorder. The subject had no concomitant therapies. On 01 July 2015 i.e. 132 days after receiving a first intramuscular dose of meningococcal vaccine in the right deltoid on 19 February 2015, the subject developed behavioral problems (batch number- M14071). The event appeared after visit 2. The subject had associated symptoms of increased aggression started on 01 July 2015. The subject was hospitalized on 21 July 2015. On the request of the subject's mother for the mental health evaluation of the subject due to his behavior problems, the subject was brought to the emergency room. There were no specific findings for lab data. The corrective treatment was not reported. The symptom of increased aggression was ongoing at the time of this report. The event of behavioral problems was resolved on 25 July 2015. The subject was discharged from the hospital on 25 July 2015. According to the investigator, the event was not related to the study vaccine or trial procedures. Relationship to investigational product according to company: not associated. The serious adverse event did not lead to the termination of the subject from the study. List of documents held by sender: none. Follow up information received on 04 August 2015. The subject received corrective treatment with TOPAMAX to help with appetite control. Follow up information received on 28 August 2015. It was confirmed that there were no other treatment plans other than the addition of TOPAMAX to control appetite as that was what his behavior concerns were stemming from. No additional therapies were given or prescribed. Follow up information received on 04 September 2015. The subject received concomitant medication with PROZAC, INTUNIV, SINGULAIR, PATANASE, Melatonin, NASONEX, TRILEPTAL, RISPERDAL and ZYRTEC. The subject received corrective treatment with behavioral group therapy. According to the investigator, the event was not related to the concomitant medications given.
Age: 1.28
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEPA, VARCEL
Symptoms: Blister, Rash, Vaccination site papule, Vaccination site rash
Clinical narrative: Developed rash at vaccine administration site (L thigh) which spread to face and other thigh. PE vesicles on face, papules on thigh surrounding site.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site discolouration
Clinical narrative: Patient reports a mild bruise with slight discoloration, approx. 2 inches in diameter, at the site of injection. Activities of daily living are not affected, no other adverse effects noted.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Injection site atrophy, Injection site pain, Pain
Clinical narrative: First 3 days felt like "Tetanus shot" - hot and painful, red. On 4th day, noticed a tiny dimple in middle of (L) deltoid. Started getting bigger and remained sore. Presently 2 cm deep and 2 1/2 in round. Saw ID doc - no infection. Seen at urgent care. US on 12/14.
Age: 21.0
Sex: M
Vaccine: YF
Symptoms: Loss of consciousness, Seizure
Clinical narrative: Pt was given the shot SQ and within 10 seconds blanked out and then seized for about 10 seconds...He regained consciousness with no memory of event.
Age: 24.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Impaired work ability, Injection site pain, Injection site reaction, Injection site warmth, Malaise
Clinical narrative: Missed work due to feeling ill and having arm pain at injection. Large welt present and warm to the touch. He declined a visit at this time. Vaccines of Tdap and PREVNAR 13 given in (L) arm as requested by patient.
Age: 24.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Urticaria
Clinical narrative: Missed work due to feeling ill and having arm pain at injection. Large welt present and warm to the touch. He declined a visit at this time. Vaccines of Tdap and PREVNAR 13 given in (L) arm as requested by patient.
Age: 1.4
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Blood culture negative, CSF culture negative, CSF test normal, Computerised tomogram normal, Culture urine negative
Clinical narrative: Complex febrile seizure (resolved Todd's Paralysis).
Age: 1.4
Sex: F
Vaccine: DTAP, FLU3, HIBV
Symptoms: Febrile convulsion, Full blood count normal, Metabolic function test normal, Postictal paralysis, Urine analysis normal
Clinical narrative: Complex febrile seizure (resolved Todd's Paralysis).
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Right upper arm redness and swelling at injection site. Cool Compress and pain reliever given by mother.
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site joint movement impairment, Injection site pain, Pain in extremity
Clinical narrative: Pain in (R) shoulder and arm to wrist - 7PM 10/13/15 (R) shoulder and upper arm locked. 10/14/15 applied heat and ice pack, ARNICA Gel, Acetaminophen continuously. Shoulder still sore and stiff at 12/11/15. Have consulted Dr, 11/13/15 - personal physician, chiropractor 12/11/15.
Age: 57.0
Sex: F
Vaccine: PNC13
Symptoms: Axillary pain, Breast pain, Induration, Injection site pain, Lymphadenopathy
Clinical narrative: Swollen glands under arm pit area, collar bone, and arm had about 4 inch hard area. Still on 12/8/15 can still feel where shot was given. A lot of pain under arm pit area and left side of breast.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cyanosis, Pyrexia, Swelling, Urticaria
Clinical narrative: Mom states infant had swelling and whelping/hives all over body. Mom states infants lips turned blue and had hives around mouth as well. Fever up to 102 degrees F.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Unable to move arm since he was given the flu shot.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Abdominal pain, Constipation, Flatulence, Irritability
Clinical narrative: Abdominal pain, constipation, fussiness, gas.
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal rigidity, Dyspnoea, Headache, Hyperhidrosis, Nausea
Clinical narrative: In 30 seconds: Severe headache - a 10 on a scale of 1 to 10, severe Vertigo, severe Nausea, Shortness of breath, tight abdomen, throat felt like it was closing, profuse perspiration. No treatment action was taken at the clinic despite my report of a reaction. Went to ER much later in the day. Prescribed EpiPens by a ER doctor.
Age: 65.0
Sex: M
Vaccine: TDAP
Symptoms: Throat tightness, Vertigo
Clinical narrative: In 30 seconds: Severe headache - a 10 on a scale of 1 to 10, severe Vertigo, severe Nausea, Shortness of breath, tight abdomen, throat felt like it was closing, profuse perspiration. No treatment action was taken at the clinic despite my report of a reaction. Went to ER much later in the day. Prescribed EpiPens by a ER doctor.
Age: 17.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Arthralgia, Blood culture negative, C-reactive protein increased, Chest X-ray normal, Complement factor C3
Clinical narrative: On 12/11: pain at injection site, rash, fever, and joint pain. Tachycardic to 106, concern for sepsis, ultimately was hospitalized.
Age: 17.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Complement factor C4, Complement factor normal, Full blood count abnormal, HIV test negative, Injection site pain
Clinical narrative: On 12/11: pain at injection site, rash, fever, and joint pain. Tachycardic to 106, concern for sepsis, ultimately was hospitalized.
Age: 17.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Rash, Red blood cell sedimentation rate increased, Tachycardia
Clinical narrative: On 12/11: pain at injection site, rash, fever, and joint pain. Tachycardic to 106, concern for sepsis, ultimately was hospitalized.
Age: 2.0
Sex: M
Vaccine: DTAP, FLU4, HEP, HIBV, MMR, PNC13, VARCEL
Symptoms: Abasia, Injected limb mobility decreased, Pain
Clinical narrative: Patient's father called at 1:15pm asking to speak to a nurse. Reports his daughter received vaccines yesterday and now is unable to move her leg. He reports she is in pain and is unable to walk. No additional s/s reported. Nurse informs parent to take  patient to the emergency room immediately.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Chest X-ray, Cough, Influenza virus test, Pain, Pyrexia
Clinical narrative: Fever greater then 100 F, runny nose, body aches, severe cough.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Rhinorrhoea, Streptococcus test
Clinical narrative: Fever greater then 100 F, runny nose, body aches, severe cough.
Age: 83.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Cellulitis, Erythema
Clinical narrative: Flu shot - redness on 12/09/2015. Prevnar shot - redness on 12/10/2015.
Age: 13.0
Sex: M
Vaccine: FLUN4, MENB
Symptoms: Cough, Full blood count normal, Influenza A virus test negative, Influenza virus test negative, Injection site pain
Clinical narrative: (R) arm pain -> site of TRUMENBA. Fever/cough/runny nose.
Age: 13.0
Sex: M
Vaccine: FLUN4, MENB
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: (R) arm pain -> site of TRUMENBA. Fever/cough/runny nose.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, 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 and medical history were not reported. On 07-DEC-2015, the patient was vaccinated with dose of an improperly stored ZOSTAVAX injection, subcutaneously, lot # reported as L032399, expiration date: 26-NOV-2016 (exact dose was not reported). Concomitant medications were not provided. There was no adverse effect reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist via a sales representative, refers to a female patient of unknown age. Pertinent medical history, concurrent conditions and drug reaction/allergies were unspecified by the reporter. On an unknown date, the patient was vaccinated with ZOSTAVAX vial, (lot number, strength, frequency, route and dose were not reported). Concomitant medications were unspecified by the reporter. On an unknown date, the patient developed shingles after receiving ZOSTAVAX. The outcome of shingles was unknown. Shingles did not require hospitalization or cause disability and no Product Quality Complaint (PQC) was involved. The relatedness between the adverse events and the therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Adverse event, Pain
Clinical narrative: Initial unsolicited report received from a consumer (via social media) on 25 July 2015. An 11-year-old female patient had received a dose of meningitis vaccine (dose, dose in series, batch number, expiry date, route and site of administration were not reported) on an unknown date. Medical history and concomitant medications were not reported. On an unknown date after vaccination, the patient experienced soreness and had some negative symptoms from the vaccine for few days. Laboratory investigations and corrective treatments were not reported. At the time of this report, the patient was recovered from the event. Documents held by sender: none.
Age: 70.0
Sex: F
Vaccine: FLU3, PNC13, TDAP
Symptoms: Burning sensation, Herpes zoster, Injection site reaction, Rash
Clinical narrative: Pt. received 3 vaccines on 12/8/15 PREVNAR 13, HD Flu and Tdap. PREVNAR 13 and HD Flu in left upper arm. Pt. started with burning and rash 4 days after immunization on (L) arm. Pt came to office 12/17/15 and has been diagnosed with shingles on left upper arm. Treatment Gabapentin and VALTREX.
Sex: F
Vaccine: MEN
Symptoms: Ill-defined disorder
Clinical narrative: Initial unsolicited report received from a consumer (parent) on 08 October 2015. This case involves a female patient (age was not reported) who was vaccinated with a dose of meningococcal vaccine (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient's health has never been the same. It was reported that the patient was forced to take the flu shot in college. Laboratory data and corrective treatment was not reported. The patient was not recovered from the event. List of documents held by sender: none.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certified medical assistant, referring to a patient of unknown age and gender. The patient concurrent condition and medical history were unknown. On 20-NOV-2015 the patient was vaccinated with an improperly stored dose of MMR II (Lot # 1003855, expiration date 05-FEB-2017) (dose, administration route and anatomical site of administration were unknown). No concomitant therapies or adverse events were reported. No product quality complaint (PQC) was involved. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MEN
Symptoms: Dysphagia, Oropharyngeal pain
Clinical narrative: Initial unsolicited report received from a consumer on 30 July 2015. A patient (age and gender not reported), whose medical history and concomitant medication were not reported, had received a dose of meningococcal vaccine (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. On an unspecified date post-vaccination, the patient experienced sore throat and could not swallow. Laboratory investigation and corrective treatment were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
Sex: M
Vaccine: MEN
Symptoms: Vaccination complication
Clinical narrative: Initial unsolicited report received from a consumer (parent) on 02 August 2015. A male patient had received a dose of meningococcal vaccine (dose, dose in series, batch number, expiry date, route and site of administration were not reported) on an unknown date. Medical history and concomitant medication were not reported. On an unknown date, after vaccination, the patient had reacted so bad to the shot. Laboratory investigations and corrective treatments were not reported. At the time of this report, the outcome of the event was unknown. Documents held by sender: none.
Sex: U
Vaccine: HPV4
Symptoms: Hepatitis B antibody negative, No therapeutic response
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of pediatric patients. No information regarding the patients' pertinent medical history, concomitant medication and drug reaction or allergies was reported. On unknown dates, the patients were vaccinated with the complete three-dose series of RECOMBIVAX HB (strength, dose, route of administration, lot # and expiration date were not provided). On unknown dates (also reported as "over the years"), the patients were nonresponders (did not have detectable antibody levels). The outcome of the event was not reported. The relatedness of the event was not reported. The relatedness between the event and RECOMBIVAX HB was not reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Chills, Pain, Pruritus, Swelling
Clinical narrative: Initial unsolicited report received from a non-healthcare professional on 10 November 2015. Case is linked to case 2015SA182410. This case involves a (age and gender unknown) patient who was vaccinated with a dose of [route and dose series not reported] MENACTRA (batch number, expiry date were not reported) and also TRUMENBA (batch number, expiry date were not reported) both received in arm on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, following the vaccination patient experienced severe swelling, chills, pain and itchiness. Laboratory investigation and corrective treatment were not reported. The outcome of event was not reported. List of documents held by sender: none.
Sex: M
Vaccine: MEN
Symptoms: Dyspnoea, Erythema, Malaise
Clinical narrative: Initial unsolicited report received from a consumer (patient's parent) on 4 August 2015.  A male (age not reported) patient, whose medical history and concomitant medication were not reported, had received a second dose of meningococcal vaccine (batch number, expiration date, dose, dose number, route and site of administration were not reported) on an unspecified date. On an unspecified date post-vaccination, the patient was very sick. The patient could not breathe and turned red. It was reported that, the patient had to wait at the clinic till he got better. Laboratory investigation and corrective treatment were not reported. At the time of this report, the patient was recovering from sickness and outcome of the events could not breathe, turned red was not reported. List of documents held by sender: none.
Sex: F
Vaccine: MEN
Symptoms: Injection site erythema, Peripheral swelling
Clinical narrative: Initial unsolicited report received from a consumer on 21 April 2015. A female patient (age not reported) whose medical history and concomitant medication were not reported had received a second dose of meningococcal vaccine (batch number, dose of vaccine, route and site of vaccination were not reported) on an unspecified date. On an unspecified date, patient's arms were swollen and seem to be red around the injection site. Corrective treatments and lab investigations were not reported. At the time of this report, the outcome of the event was reported as unknown. Documents held by sender: none.
Age: 1.29
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Blood culture negative, Differential white blood cell count normal, Full blood count normal, Pyrexia, Seizure
Clinical narrative: Developed low grade fever few hours after vaccination and high grade fever, 103 degrees after and seizure 2 days after the vaccination.
Age: 1.29
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Urine analysis normal
Clinical narrative: Developed low grade fever few hours after vaccination and high grade fever, 103 degrees after and seizure 2 days after the vaccination.
Age: 42.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: 42 y/o nurse was administered the vaccine to a patient (she did not receive the vaccine). She presented to employee health with redness on bilateral arms, neck, and lower jaw. She stated it was itchy but starting to improve. She has had similar reactions in the past when giving the vaccine.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Within 5-7 days after receiving flu vaccine, patients reports having searing pain and decreased strength to left arm as well as decreased ROM. Site of injection tender to touch.
Sex: U
Vaccine: HPV4
Symptoms: Cervix carcinoma
Clinical narrative: This spontaneous report was received from Medical Assistant concerning an unidentified patient of unknown age and gender. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with unidentified Merck HPV vaccine, it was not specified if it was GARDASIL (Lot #, dose, route and frequency not reported), or GARDASIL 9 (Lot #, dose, route and frequency were not reported). Concomitant therapies were not provided. On an unknown date, the patient experienced cervix carcinoma after receiving the vaccine. At the time of the report, the outcome of cervix carcinoma was unknown. Upon internal review cervix carcinoma was determined to be an other important medical event. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Fatigue, Headache, Malaise, Pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of respiratory tract infection viral in a 58-year-old female patient who received Influenza vaccine Quadrivalent. Concomitant products included vitamin B3, vitamin C and XALATAN eye drops. On 15th November 2015, the patient received Influenza vaccine Quadrivalent. In November 2015, several days after receiving Influenza vaccine Quadrivalent, the patient experienced respiratory tract infection viral (serious criteria GSK medically significant) and fatigue. On 15th November 2015, the patient experienced chills and feeling unwell. On 16th November 2015, the patient experienced headache and general body pain. On an unknown date, the outcome of the respiratory tract infection viral, chills, feeling unwell, fatigue, headache and general body pain were recovered/resolved. The reporter considered the respiratory tract infection viral, chills, feeling unwell, fatigue, headache and general body pain to be almost certainly related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The exact flu vaccine was not known. The reporter only knew that it was Quadrivalent. On 15th November 2015, she received the vaccine at 8:30 pm and within 30 minutes she felt the chills. It felt like she was getting sick. She woke up the next day with headache and body aches that lasted for a few days. The respiratory infection presented a few days later following those symptoms. She could not provide the lot and expiration date at the time of the call but said she would call back to provide it. She reported her symptoms to a nurse on her floor who monitored her until it resolved.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Respiratory tract infection viral
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of respiratory tract infection viral in a 58-year-old female patient who received Influenza vaccine Quadrivalent. Concomitant products included vitamin B3, vitamin C and XALATAN eye drops. On 15th November 2015, the patient received Influenza vaccine Quadrivalent. In November 2015, several days after receiving Influenza vaccine Quadrivalent, the patient experienced respiratory tract infection viral (serious criteria GSK medically significant) and fatigue. On 15th November 2015, the patient experienced chills and feeling unwell. On 16th November 2015, the patient experienced headache and general body pain. On an unknown date, the outcome of the respiratory tract infection viral, chills, feeling unwell, fatigue, headache and general body pain were recovered/resolved. The reporter considered the respiratory tract infection viral, chills, feeling unwell, fatigue, headache and general body pain to be almost certainly related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The exact flu vaccine was not known. The reporter only knew that it was Quadrivalent. On 15th November 2015, she received the vaccine at 8:30 pm and within 30 minutes she felt the chills. It felt like she was getting sick. She woke up the next day with headache and body aches that lasted for a few days. The respiratory infection presented a few days later following those symptoms. She could not provide the lot and expiration date at the time of the call but said she would call back to provide it. She reported her symptoms to a nurse on her floor who monitored her until it resolved.
Age: 12.0
Sex: M
Vaccine: HEP, IPV, TDAP
Symptoms: Chills, Confusional state, Dizziness, Myalgia, Pain
Clinical narrative: Bilateral upper extremity pain progressing over 24 hours. Confusion, lightheadedness, chills, fever, intense pain with motion (R) arm, muscle tenderness whole (R) arm > (L) arm.
Age: 12.0
Sex: M
Vaccine: HEP, IPV, TDAP
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Bilateral upper extremity pain progressing over 24 hours. Confusion, lightheadedness, chills, fever, intense pain with motion (R) arm, muscle tenderness whole (R) arm > (L) arm.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis, Injection site pain, Pain in extremity
Clinical narrative: Developed fairly severe left arm pain from injection site persisting. Dr apt 12/17/15 for severe pain L shoulder/bursitis started on Prednisone dose pack.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient reported her arm was swollen, red and painful.  She reports a similar reaction to a previous flu shot.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema
Clinical narrative: Patient had redness at injection site.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Bursitis, Injection site joint movement impairment, Injection site pain
Clinical narrative: SEVERE PAIN AND RESTRICTED RANGE OF MOTION RIGHT SHOULDER DIAGNOSED SUBACROMIAL BURSITIS.  SUSPECT INADVERTENT INJECTION INTO SUBACROMIAL SPACE.
Age: 60.0
Sex: F
Vaccine: FLU4, MMR, VARZOS
Symptoms: Chills, Extrasystoles, Pyrexia, White blood cell count increased
Clinical narrative: Chills that lasted approximately 12 hours.  Then felt she had "skipping hearting rhythm."  Went to the hospital and was admitted on 12/08/2015 with fever and elevated white count.
Age: 85.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Left arm cellulitis.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Pain, Pruritus
Clinical narrative: This spontaneous report was received from a nurse practitioner, referring to an approximately 65 year old female patient with hypercholesterolaemia, hypertension, hyperthyroidism and other unspecified concurrent condition. The patient had a drug reaction/allergy to pain medication (unspecified). On 27-AUG-2015, the patient was vaccinated with ZOSTAVAX (lot # L012039, expiration 07-JUL-2016), 0.65 ml, subcutaneous in the left arm. The patient was reported to be under unspecified concomitant medications. On an unspecified date in 2015, the patient experienced herpes zoster (reported as shingles without the rash). Symptoms included pruritus, pain and burning sensation. On an unknown date the patient sought medical attention by contacting the HCP office. The outcome of herpes zoster was reported as not recovered. The primary reporter did not provide the causality between ZOSTAVAX and herpes zoster. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site mass
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site lump in a 62-year-old female patient who received FLUARIX QUADRIVALENT (batch number C73LX, expiry date 30th June 2016). On 9th December 2015, the patient received FLUARIX QUADRIVALENT .5 ml. On 9th December 2015, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced injection site lump. On an unknown date, the outcome of the injection site lump was unknown. It was unknown if the reporter considered the injection site lump to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: This case was not previously reported to anyone. The patient experienced lump on left deltoid (injection site).
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site redness in a female patient who received FLULAVAL QUADRIVALENT (batch number C92E7, expiry date June 2016). On 10th December 2015, the patient received FLULAVAL QUADRIVALENT .5 ml. On 10th December 2015, less than a day after receiving FLULAVAL QUADRIVALENT, the patient experienced injection site redness, injection site pain and injection site warmth. On an unknown date, the outcome of the injection site redness, injection site pain and injection site warmth were unknown. It was unknown if the reporter considered the injection site redness, injection site pain and injection site warmth to be related to FLULAVAL QUADRIVALENT. Additional details were received as follows: The reporter would like to know whether the patient should be concerned about receiving Flu vaccines in future. The reporter did not have the date of birth of the patient.
Age: 1.02
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Whole body rash and fever.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site discharge, Injection site erythema, Injection site scab, Pain in extremity
Clinical narrative: Started with itching right after getting the shot. Then started to have arm aching that evening. Pt has had redness off/on since Pt developing oozing and crustiness at site. Pt has an area 8.5 cm x 21.5 cm red reaction from (L) shoulder to (L) elbow.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pruritus
Clinical narrative: Started with itching right after getting the shot. Then started to have arm aching that evening. Pt has had redness off/on since Pt developing oozing and crustiness at site. Pt has an area 8.5 cm x 21.5 cm red reaction from (L) shoulder to (L) elbow.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Injection site pain, Oedema, Pruritus
Clinical narrative: Pt. rec'd  5 yr IMM. On 12/15/15 in office. Seen for s/s 'reaction' today. S/s -> edema, pruritis, erythema and c/o pain to site on lt upper arm. Tx with prn BENADRYL (10 ml) and ibuprofen (10 ml) q 6 hours, cool compresses prn and to return if s/s increase.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Itching, red, swollen at local site. Diphenhydramine 50 mg PRN.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Nausea
Clinical narrative: 2 days after administration, pt began experiencing sporadic waves of nausea (no vomiting) for 5 days. She recovered w/o treatment.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Injection site joint movement impairment, Injection site pain
Clinical narrative: Persistent left shoulder pain with onset of limitation of ROM and weakness.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Cough, Croup infectious, Decreased appetite, Diarrhoea, Dry mouth
Clinical narrative: PREVNAR 13 was given on Nov 17th, 1. Traveled by plane on Nov 18th, (9 hours) no sick contacts per report. 2. Nov 19th lack of fluid, mouth dry, drank water only, Felt cold and no appetite. 3. Friday the 20th in am, was at gluten free deli, continues with no appetite generalized myalgia, no injection site problems noted. but feverish 3:00pm with temp 103, spouse was not sick, throughout the day (felt fatigue, sleepy), took 200mg Aleve, drinking herbal tea. 4. Nov 21st 5 water stools, with myalgia continues, injection site soreness without erythematous, but appetite return and grandchildren with some URI symptoms but not new. 5. Site soreness resolved Nov 23rd, then croupy cough started, (did not take any OTC meds). 6. Returned by plane Nov 28th with loss of voice, coughing, no current meds, Currently takes some TEA Virubamax (herbal), doing organic bullion. Voice cracking today (12/4/15), multidextrin in herbal tea which she has allergy to. ASSESSMENT/PLAN: (12/4/15) 1. Laryngitis ongoing. will start on prednisone 10mg po daily x 5 days only. Will fill out Vaccine adverse even reporting system as seems the patient was exposed to multiple viruses during travel explaining symptoms, however the process of injection prior to all the symptoms warrants reporting. fever 103, fatigue, myalgia, diarrhea resolved, loss of appetite resolved voice changes (ongoing issues) documented per patient. reviewed all adverse problems on handout.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Dysphonia, Fatigue, Feeling cold, Fluid intake reduced, Injection site pain
Clinical narrative: PREVNAR 13 was given on Nov 17th, 1. Traveled by plane on Nov 18th, (9 hours) no sick contacts per report. 2. Nov 19th lack of fluid, mouth dry, drank water only, Felt cold and no appetite. 3. Friday the 20th in am, was at gluten free deli, continues with no appetite generalized myalgia, no injection site problems noted. but feverish 3:00pm with temp 103, spouse was not sick, throughout the day (felt fatigue, sleepy), took 200mg Aleve, drinking herbal tea. 4. Nov 21st 5 water stools, with myalgia continues, injection site soreness without erythematous, but appetite return and grandchildren with some URI symptoms but not new. 5. Site soreness resolved Nov 23rd, then croupy cough started, (did not take any OTC meds). 6. Returned by plane Nov 28th with loss of voice, coughing, no current meds, Currently takes some TEA Virubamax (herbal), doing organic bullion. Voice cracking today (12/4/15), multidextrin in herbal tea which she has allergy to. ASSESSMENT/PLAN: (12/4/15) 1. Laryngitis ongoing. will start on prednisone 10mg po daily x 5 days only. Will fill out Vaccine adverse even reporting system as seems the patient was exposed to multiple viruses during travel explaining symptoms, however the process of injection prior to all the symptoms warrants reporting. fever 103, fatigue, myalgia, diarrhea resolved, loss of appetite resolved voice changes (ongoing issues) documented per patient. reviewed all adverse problems on handout.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Laryngitis, Myalgia, Pyrexia, Somnolence
Clinical narrative: PREVNAR 13 was given on Nov 17th, 1. Traveled by plane on Nov 18th, (9 hours) no sick contacts per report. 2. Nov 19th lack of fluid, mouth dry, drank water only, Felt cold and no appetite. 3. Friday the 20th in am, was at gluten free deli, continues with no appetite generalized myalgia, no injection site problems noted. but feverish 3:00pm with temp 103, spouse was not sick, throughout the day (felt fatigue, sleepy), took 200mg Aleve, drinking herbal tea. 4. Nov 21st 5 water stools, with myalgia continues, injection site soreness without erythematous, but appetite return and grandchildren with some URI symptoms but not new. 5. Site soreness resolved Nov 23rd, then croupy cough started, (did not take any OTC meds). 6. Returned by plane Nov 28th with loss of voice, coughing, no current meds, Currently takes some TEA Virubamax (herbal), doing organic bullion. Voice cracking today (12/4/15), multidextrin in herbal tea which she has allergy to. ASSESSMENT/PLAN: (12/4/15) 1. Laryngitis ongoing. will start on prednisone 10mg po daily x 5 days only. Will fill out Vaccine adverse even reporting system as seems the patient was exposed to multiple viruses during travel explaining symptoms, however the process of injection prior to all the symptoms warrants reporting. fever 103, fatigue, myalgia, diarrhea resolved, loss of appetite resolved voice changes (ongoing issues) documented per patient. reviewed all adverse problems on handout.