chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Lymphadenopathy, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient appeared to clinic 7 days post vaccination with a picture of arm. Easy to tell there was redness and appeared to have been raised. She stated painful, warm to touch some swelling in lymph nodes in under arm. Upon examination on 2/18/2019 there was slight redness, no induration and still some tenderness. No palpable lymph nodes on 2/18/19.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Tenderness
Clinical narrative: Patient appeared to clinic 7 days post vaccination with a picture of arm. Easy to tell there was redness and appeared to have been raised. She stated painful, warm to touch some swelling in lymph nodes in under arm. Upon examination on 2/18/2019 there was slight redness, no induration and still some tenderness. No palpable lymph nodes on 2/18/19.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Hyperhidrosis, Throat tightness
Clinical narrative: PATIENT REPORTED FEELING LIKE HE WAS BURNING UP, SWEATING, THROAT TIGHTNESS. OCCURRED APPROXIMATELY ONE HOUR AFTER INJECTION.
Age: 51.0
Sex: M
Vaccine: HEPA
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: Pt. states he received the Hep A vaccine for post exposure during mass clinic at the County health unit on 02/13/2019. Received the vaccine around 1 pm and then noticed his legs were itching several hours later, the next morning he was itching more and noticed small red raised area similar to poison oak rash, on his arms legs and chest. States he has never had a reaction to a vaccine but was told in 2007 that he could be allergic to latex after he developed numerous mouth ulcers after hip surgery.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea
Clinical narrative: Nausea, headache, fatigue.
Sex: U
Vaccine: PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This non-valid spontaneous report was received from a nurse and refers to multiple unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant therapies were not reported. On unknown dates, unspecified patients were vaccinated with improperly stored doses of PNEUMOVAX 23 (strength, dose and route of administration were not reported) lot # R007722, expiration date 10-MAR-2020 and with ROTATEQ (strength, dose and route of administration were not reported) Lot # R005869, expiration date 23-OCT-2019, both for prophylaxis. The vaccines were stored in the lowest temperature below 36 degrees Fahrenheit/ 2 degrees Celsius (1.16 degrees Celsius) for 30 minutes and the highest temperature above 47 degrees Fahrenheit/ 9 degrees Celsius (9.08 degrees Celsius) for 4 hours and 15 minutes (date was not reported). There was a data logger involved and no previous temperature excursion. No adverse effects were reported.
Age: 17.0
Sex: F
Vaccine: FLUX, HPV9, MENB
Symptoms: Fall, Immediate post-injection reaction, Loss of consciousness
Clinical narrative: This spontaneous report was received from a physician and refers to a white 17-year-old female patient. The patient's medical history, concomitant therapies, drug reaction and allergies were not reported. On 18-SEP-2018 at 3 pm, the patient was vaccinated with first dose of GARDASIL 9, in the left arm, lot#N035957, expiration date 10-OCT-2020 (dose and route of administration were not reported), influenza virus vaccine (unspecified)(INFLUENZA VIRUS VACCINE (UNSPECIFIED))-(Sanofi Pasteur), the fifth dose in right arm, lot#VI980AA, (dose, route of administration and expiration date were not reported) and meningococcal B rfHbp vaccine (E. coli)MENINGOCOCCAL B rfHbp vaccine)-(Pfizer), the second dose in right arm, (dose, route of administration and expiration date were not reported ) for prophylaxis and immediately fell forward. The loss of consciousness lasted less than 1 minute. The patient's mother reported, that she experienced the same situation in the past. The outcome of the event was reported as recovered. The relatedness between the event and suspected vaccines was not reported. Upon internal review, loss of consciousness was considered as medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles (had a serious case of shingles last summer). Previously administered products included SHINGRIX (1st dose received on an unknown date). On 10th February 2019, the patient received the 2nd dose of SHINGRIX. On 11th February 2019, 1 days after receiving SHINGRIX, the patient experienced chills and body temperature increased. The patient was treated with benadryl (nos) (Benadryl) and paracetamol (Tylenol). On an unknown date, the outcome of the chills and body temperature increased were unknown. It was unknown if the reporter considered the chills and body temperature increased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported.After vaccination, the patient was fine during the day, but awoke with chills. They continued to grow worse during the morning. The patient's husband reported that when they got a reading of 103.4 F for patient's body temperature, he grew very concerned. Benadryl and Tylenol had helped them through the day but the patient was clearly having trouble. The patient's breathing was not affected, but it was a reaction to the shot.
Sex: U
Vaccine: MENB
Symptoms: Meningococcal infection, Neisseria test positive, Vaccination failure
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received BEXSERO for prophylaxis. Co-suspect products included BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO and the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO and BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant) and meningococcal infection (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and meningococcal infection were unknown. It was unknown if the reporter considered the vaccination failure and meningococcal infection to be related to BEXSERO and BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. The physician stated that she had a patient that had received 2 doses of BEXSERO and later experienced meningococcal disease which was confirmed as serogroup B, by the local hospital. The physician stated that the patient did not experience any serious complications or consequences. This case was considered as suspected vaccination failure as time to onset for the event for targeted disease was unknown. Lab Comments: On an unknown date, laboratory test confirmed serogroup B for meningococcal infection by the local hospital.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site pruritus, Pain, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 58-year-old female patient who received SHINGRIX for prophylaxis. On 18th November 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced chills, general body pain, injection site itching and pain in arm. On an unknown date, the outcome of the chills and general body pain were recovered/resolved and the outcome of the injection site itching and pain in arm were not recovered/not resolved. It was unknown if the reporter considered the chills, general body pain, injection site itching and pain in arm to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right arm. The patient experienced pain at the injection site, and was experiencing pain down her entire arm. The patient also experienced chills and body aches that lasted for about 2 days. The patient also had itching at the injection site which comes and goes. The reporter did not give consent to follow up. The patient was referred to her healthcare professional. No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of sickness in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown. It was unknown if the reporter considered the sickness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The consumer reported that, her primary care doctor got really sick after receiving the SHINGRIX. The doctor almost went to the emergency room, but did not.  The reporter was not sure if this was the 1st dose or 2nd dose of SHINGRIX. The reporter did not have any additional details.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Gait inability, Guillain-Barre syndrome, Immunoglobulin therapy, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 63-year-old male patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 27th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 42 days after receiving SHINGRIX and an unknown time after receiving SHINGRIX, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), tingling and unable to walk. The patient was treated with immunoglobulins nos (Immunoglobulin Therapy (Ingredients Unknown)) and non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the guillain barre syndrome, tingling and unable to walk were not recovered/not resolved. It was unknown if the reporter considered the guillain barre syndrome, tingling and unable to walk to be related to SHINGRIX. Additional details were provided as follows: The patient's wife reported this case. On 27th June 2018, the patient received 1st dose of SHINGRIX 0.5ml (intramuscular) on the left deltoid. The patient received 2nd dose of SHINGRIX on the left deltoid. Approximately 6 to 7 weeks after receiving 2nd dose of SHINGRIX, the patient experienced tingling in toes and it continued to get worse until the patient had to go the emergency room. The reporter stated that, it had gotten to the point where the patient could not walk. The patient was diagnosed with Guillain Barre Syndrome. The patient was still recovering and was currently in physical therapy. The patient required an emergency room visit. The reporter did not consent to follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Anaesthesia, Balance disorder, CSF protein increased, Cardiac function test normal, Computerised tomogram head normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 63-year-old male patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 27th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 42 days after receiving SHINGRIX and an unknown time after receiving SHINGRIX, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), tingling and unable to walk. The patient was treated with immunoglobulins nos (Immunoglobulin Therapy (Ingredients Unknown)) and non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the guillain barre syndrome, tingling and unable to walk were not recovered/not resolved. It was unknown if the reporter considered the guillain barre syndrome, tingling and unable to walk to be related to SHINGRIX. Additional details were provided as follows: The patient's wife reported this case. On 27th June 2018, the patient received 1st dose of SHINGRIX 0.5ml (intramuscular) on the left deltoid. The patient received 2nd dose of SHINGRIX on the left deltoid. Approximately 6 to 7 weeks after receiving 2nd dose of SHINGRIX, the patient experienced tingling in toes and it continued to get worse until the patient had to go the emergency room. The reporter stated that, it had gotten to the point where the patient could not walk. The patient was diagnosed with Guillain Barre Syndrome. The patient was still recovering and was currently in physical therapy. The patient required an emergency room visit. The reporter did not consent to follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Constipation, Dysstasia, Fall, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 63-year-old male patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 27th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 42 days after receiving SHINGRIX and an unknown time after receiving SHINGRIX, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), tingling and unable to walk. The patient was treated with immunoglobulins nos (Immunoglobulin Therapy (Ingredients Unknown)) and non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the guillain barre syndrome, tingling and unable to walk were not recovered/not resolved. It was unknown if the reporter considered the guillain barre syndrome, tingling and unable to walk to be related to SHINGRIX. Additional details were provided as follows: The patient's wife reported this case. On 27th June 2018, the patient received 1st dose of SHINGRIX 0.5ml (intramuscular) on the left deltoid. The patient received 2nd dose of SHINGRIX on the left deltoid. Approximately 6 to 7 weeks after receiving 2nd dose of SHINGRIX, the patient experienced tingling in toes and it continued to get worse until the patient had to go the emergency room. The reporter stated that, it had gotten to the point where the patient could not walk. The patient was diagnosed with Guillain Barre Syndrome. The patient was still recovering and was currently in physical therapy. The patient required an emergency room visit. The reporter did not consent to follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Hyperaesthesia, Immunoglobulin therapy, Incontinence, Lumbar puncture abnormal, Muscular weakness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 63-year-old male patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 27th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 42 days after receiving SHINGRIX and an unknown time after receiving SHINGRIX, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), tingling and unable to walk. The patient was treated with immunoglobulins nos (Immunoglobulin Therapy (Ingredients Unknown)) and non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the guillain barre syndrome, tingling and unable to walk were not recovered/not resolved. It was unknown if the reporter considered the guillain barre syndrome, tingling and unable to walk to be related to SHINGRIX. Additional details were provided as follows: The patient's wife reported this case. On 27th June 2018, the patient received 1st dose of SHINGRIX 0.5ml (intramuscular) on the left deltoid. The patient received 2nd dose of SHINGRIX on the left deltoid. Approximately 6 to 7 weeks after receiving 2nd dose of SHINGRIX, the patient experienced tingling in toes and it continued to get worse until the patient had to go the emergency room. The reporter stated that, it had gotten to the point where the patient could not walk. The patient was diagnosed with Guillain Barre Syndrome. The patient was still recovering and was currently in physical therapy. The patient required an emergency room visit. The reporter did not consent to follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Neuralgia, Neurological examination abnormal, Neuropathy peripheral, Nuclear magnetic resonance imaging spinal normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 63-year-old male patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 27th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 42 days after receiving SHINGRIX and an unknown time after receiving SHINGRIX, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), tingling and unable to walk. The patient was treated with immunoglobulins nos (Immunoglobulin Therapy (Ingredients Unknown)) and non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the guillain barre syndrome, tingling and unable to walk were not recovered/not resolved. It was unknown if the reporter considered the guillain barre syndrome, tingling and unable to walk to be related to SHINGRIX. Additional details were provided as follows: The patient's wife reported this case. On 27th June 2018, the patient received 1st dose of SHINGRIX 0.5ml (intramuscular) on the left deltoid. The patient received 2nd dose of SHINGRIX on the left deltoid. Approximately 6 to 7 weeks after receiving 2nd dose of SHINGRIX, the patient experienced tingling in toes and it continued to get worse until the patient had to go the emergency room. The reporter stated that, it had gotten to the point where the patient could not walk. The patient was diagnosed with Guillain Barre Syndrome. The patient was still recovering and was currently in physical therapy. The patient required an emergency room visit. The reporter did not consent to follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pain in extremity, Paraesthesia, Spinal X-ray, Spinal X-ray normal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 63-year-old male patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 27th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 42 days after receiving SHINGRIX and an unknown time after receiving SHINGRIX, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), tingling and unable to walk. The patient was treated with immunoglobulins nos (Immunoglobulin Therapy (Ingredients Unknown)) and non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the guillain barre syndrome, tingling and unable to walk were not recovered/not resolved. It was unknown if the reporter considered the guillain barre syndrome, tingling and unable to walk to be related to SHINGRIX. Additional details were provided as follows: The patient's wife reported this case. On 27th June 2018, the patient received 1st dose of SHINGRIX 0.5ml (intramuscular) on the left deltoid. The patient received 2nd dose of SHINGRIX on the left deltoid. Approximately 6 to 7 weeks after receiving 2nd dose of SHINGRIX, the patient experienced tingling in toes and it continued to get worse until the patient had to go the emergency room. The reporter stated that, it had gotten to the point where the patient could not walk. The patient was diagnosed with Guillain Barre Syndrome. The patient was still recovering and was currently in physical therapy. The patient required an emergency room visit. The reporter did not consent to follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Urinary hesitation, Urinary retention
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of guillain barre syndrome in a 63-year-old male patient who received SHINGRIX (batch number 524S7, expiry date 12th February 2021) for prophylaxis. Concomitant products included SHINGRIX. On 27th August 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, 42 days after receiving SHINGRIX and an unknown time after receiving SHINGRIX, the patient experienced guillain barre syndrome (serious criteria GSK medically significant), tingling and unable to walk. The patient was treated with immunoglobulins nos (Immunoglobulin Therapy (Ingredients Unknown)) and non-drug therapy (Physical Therapy (Nos)). On an unknown date, the outcome of the guillain barre syndrome, tingling and unable to walk were not recovered/not resolved. It was unknown if the reporter considered the guillain barre syndrome, tingling and unable to walk to be related to SHINGRIX. Additional details were provided as follows: The patient's wife reported this case. On 27th June 2018, the patient received 1st dose of SHINGRIX 0.5ml (intramuscular) on the left deltoid. The patient received 2nd dose of SHINGRIX on the left deltoid. Approximately 6 to 7 weeks after receiving 2nd dose of SHINGRIX, the patient experienced tingling in toes and it continued to get worse until the patient had to go the emergency room. The reporter stated that, it had gotten to the point where the patient could not walk. The patient was diagnosed with Guillain Barre Syndrome. The patient was still recovering and was currently in physical therapy. The patient required an emergency room visit. The reporter did not consent to follow-up.
Age: 51.0
Sex: F
Vaccine: FLU4, HEPA
Symptoms: Injection site pain, Nuclear magnetic resonance imaging
Clinical narrative: Pt reported (R) deltoid/shoulder pain w/in 15 min of vaccine administration and notified provider on 1-3-19 of pain. No erythema or redness at injection site.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Eye swelling, Headache, Lip swelling, Swelling face, Yellow skin
Clinical narrative: TC from parent indicating that patient had possible reaction to vaccine given on 2/15/19. Patient received 2nd HPV vaccine. Parent reports that patient had a strong headache soon after receiving the vaccine. The next morning, patient had facial swelling (eyes, lips) and face was yellow per parent. Parent took patient to Urgent Care on 2/16/19, patient given a shot in the shoulder and 2 pills, parent unsure what was given. The doctor did not say what it could have been other than may have been from the vaccine. Parent showed vaccine documentation to doctor of what vaccine patient received. Patient felt better soon after receiving medication and slept. Per parent, patient is doing better. Per parent, patient did not have any issues with receiving HPV or other vaccines given on 8/10/18.
Age: 44.0
Sex: F
Vaccine: FLU4, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Incorrect Vaccine given to patient. PROQUAD given instead of MMR. No adverse reaction noted at this time.
Age: 3.0
Sex: M
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Vaccine administered subcutaneously in patients R thigh as patient was being restrained by parent. Patient was resisting vaccination, and vaccine administered at possibly narrow angle. Vaccine administered left small raised area.
Age: 1.25
Sex: M
Vaccine: DTAP, DTAPHEPBIP, HEPA, HIBV
Symptoms: Extra dose administered, Nausea, Pyrexia
Clinical narrative: Pt received 2 DTAP containing vaccine in the same day. Next day pt had a 103 fever with nausea.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Activated partial thromboplastin time, Epistaxis, Full blood count, Headache, Pain
Clinical narrative: C/O body itching and tingling of throat - Dr visit 2/9/19 treated with BENADRYL. Body aches, headache. Epistaxis.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Pharyngeal paraesthesia, Platelet count, Prothrombin time, Pruritus generalised
Clinical narrative: C/O body itching and tingling of throat - Dr visit 2/9/19 treated with BENADRYL. Body aches, headache. Epistaxis.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Burning sensation, Chills, Diarrhoea
Clinical narrative: At  the time of the vaccination, I could feel it pooling in my arm, and I could feel a burning sensation (and it burnt as it spread). Within 30 minutes  I got dizzy, but this only lasted a few seconds. Within an hour, I felt like I was going to vomit and have diarrhea (this was not severe). Within two hours I was weak, my arm was getting sore and stiff, and I started shivering. Within seven hours, I felt like I had the flu. During the night I got extremely sick, extreme soreness of arm, headaches, muscle aches, fever, severe joint pain, pain extending into eye sockets, and slight swelling of throat.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Eye pain, Headache, Influenza like illness, Malaise
Clinical narrative: At  the time of the vaccination, I could feel it pooling in my arm, and I could feel a burning sensation (and it burnt as it spread). Within 30 minutes  I got dizzy, but this only lasted a few seconds. Within an hour, I felt like I was going to vomit and have diarrhea (this was not severe). Within two hours I was weak, my arm was getting sore and stiff, and I started shivering. Within seven hours, I felt like I had the flu. During the night I got extremely sick, extreme soreness of arm, headaches, muscle aches, fever, severe joint pain, pain extending into eye sockets, and slight swelling of throat.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Myalgia, Nausea, Pain in extremity, Pharyngeal swelling
Clinical narrative: At  the time of the vaccination, I could feel it pooling in my arm, and I could feel a burning sensation (and it burnt as it spread). Within 30 minutes  I got dizzy, but this only lasted a few seconds. Within an hour, I felt like I was going to vomit and have diarrhea (this was not severe). Within two hours I was weak, my arm was getting sore and stiff, and I started shivering. Within seven hours, I felt like I had the flu. During the night I got extremely sick, extreme soreness of arm, headaches, muscle aches, fever, severe joint pain, pain extending into eye sockets, and slight swelling of throat.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Sensory disturbance
Clinical narrative: At  the time of the vaccination, I could feel it pooling in my arm, and I could feel a burning sensation (and it burnt as it spread). Within 30 minutes  I got dizzy, but this only lasted a few seconds. Within an hour, I felt like I was going to vomit and have diarrhea (this was not severe). Within two hours I was weak, my arm was getting sore and stiff, and I started shivering. Within seven hours, I felt like I had the flu. During the night I got extremely sick, extreme soreness of arm, headaches, muscle aches, fever, severe joint pain, pain extending into eye sockets, and slight swelling of throat.
Age: 25.0
Sex: F
Vaccine: HEPA, MNQ, TDAP, TYP
Symptoms: Injection site bruising, Injection site pain, Injection site reaction, Injection site warmth, Rash erythematous
Clinical narrative: Tiny red spots appeared on LUE the night of 2/16/19. On 2/17/19, red spots moved down arm to elbow. Feels hot and burning. Bruising appeared in the Left bicep area. Client following up with PCP.
Age: 33.0
Sex: F
Vaccine: YF
Symptoms: Rash
Clinical narrative: I received the yellow fever vaccine before my trip. I got a severe neck rash after the vaccine. I had never had such an excruciating painful rash in my life. The rash eventually resolved with time.
Age: 17.0
Sex: F
Vaccine: FLU4, HPV9, MENB, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Client passed out while receiving 4th vaccination of 4 total vaccines. Showed no symptoms of problem prior to passing out. Staff laid client flat on exam table, administered O2 per protocol. Client recovered after approximately 1-2 minutes. Client remained flat on exam table for 10 minutes, then sat up and remained sitting for another 10 minutes, when client reported feeling well and stable was allowed to stand. Client stood without complications prior to leaving facility. Mother reports client has passed out from previous blood draws.
Age: 27.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injected limb mobility decreased, Injection site rash, Neck pain
Clinical narrative: Patient received injection in the AM. In the afternoon she had difficulty moving/lifting her left arm and slight neck pain. Reports she was fatigued and had a small rash at injection site. Symptoms resolved the following day with residual soreness and small rash on her arm only. Patients symptoms were reported via telephone call by her.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Headache, Pyrexia
Clinical narrative: Headache and Fever starting a few hours after vaccines.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HIBV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Two doses of Hib inadvertently given on same date. No immediate effects noted.
Age: 42.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: There was no adverse event but the patient was administered an immunization outside of the  guidelines.
Age: 45.0
Sex: M
Vaccine: HEPAB, PPV
Symptoms: Computerised tomogram head normal, Discomfort, Facial paralysis
Clinical narrative: The patient had facial drooping and discomfort 2-3 days after the vaccines listed above. He was sent to the ED and diagnosis of Bell's Palsy was confirmed.
Age: 16.0
Sex: F
Vaccine: HPV4, MENB, MNQ
Symptoms: Dizziness, Pallor
Clinical narrative: Dizzy, pale.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injected limb mobility decreased, Joint stiffness, Joint swelling, Joint warmth
Clinical narrative: This spontaneous report was received via Pfizer from a 50-year-old female patient regarding herself. The patient's current conditions included vitamin D deficiency, vitamin C deficiency, sinus and allergy issues. She had allergy and sinus issues for her whole life, but seemed to be gotten worse with age. No relevant family history relevant. She stated that her primary care provider did not give her the vaccine but referred her to an allergist who gave her the shot. The allergy specialist that she visited did some immune testing and it showed that her immune system vas very low. He thought the PNEUMOVAX 23 or PREVNAR 13 (reported as Prevnar 13) would help her. On an unknown date in February 2017, the patient was vaccinated with PNEUMOVAX 23 or PREVNAR 13 in the left arm for immunisation. There no reactions to prior vaccinations and patient's illness at time of vaccination was none. Concomitant therapies included fluticasone propionate(FLONASE), albuterol, cetirizine hydrochloride(ZYRTEC), vitamin D (unspecified), vitamin E and ascorbic acid. The patient clarified that she believes that she got the PNEUMOVAX 23 (reported as Prvevnar 23 shot). The following morning after vaccination, she could not move her arm (Vaccination site joint movement impairment). She had joint pain (and arthralgia) and the joint was stiff, swollen and warm (joint stiffness, joint swelling and joint warmth). She called the doctor's office and was advised that some of the vaccine might had had gotten caught up in her muscle. She was asked to just ice it. She iced and babied her arm. Finally, after 3 or 4 weeks, she was able to move it more. However, she was still experiencing stiffness in her left shoulder that was persistent. She had since had her immune levels retested and they were increased. She also thought she received allergy shots around the same time that she received the vaccine (no details reported). The outcome of joint stiffness was reported as not recovered/not resolved. The outcome for the other events was unknown. No causality assessment was reported.
Age: 0.08
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 1-month-old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant drugs were not reported. On 11-FEB-2019, the patient was inadvertently vaccinated with LIQUID PEDVAXHIB lot# R013573, expiration date 22-MAR-2021 (exact dose, frequency, route and site of administration were not reported) instead of RECOMBIVAX HB for prophylaxis. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. The patient's concurrent condition, pertinent medical history. concomitant medication and drug allergies/reactions were not reported. On 24-JAN-2019, the patient was vaccinated with M-M-R II, subcutaneously (strength, dose, site of administration, lot number and expiry date were not reported) for prophylaxis. On 31-JAN-2019, the patient was vaccinated with VARIVAX subcutaneously (strength, dose, site of administration, lot number and expiry date were not reported) for prophylaxis. No known adverse effects were reported.
Sex: U
Vaccine: PNC, PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to an adult patient around the age of 41 years old. The patient's medical history included pneumonia. The patient's concurrent conditions included unspecified pulmonary problems. No information regarding concomitant medications was provided. On an unknown dates, reported as during unspecified flu seasons, the patient was vaccinated with two doses of PNEUMOVAX 23 (doses, routes of administration, lot # and expiration dates were unknown) and a dose of PREVENAR (dose, route of administration, lot # and expiration date were unknown), all for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and SHINGRIX. Additional details were provided as follows: This case was reported by the patient's brother. The age at vaccination was not reported. The patient received both the SHINGRIX shots and still experienced shingles. The reporter was not comfortable to give the patient information and did not give consent to be followed up. This case was considered as suspected vaccination failure as time to onset for the event for targeted disease was unknown.
Age: 54.0
Sex: M
Vaccine: MMR, MNQ, YF
Symptoms: Expired product administered
Clinical narrative: Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a 54 years old male patient who was vaccinated with a 0.5ml dose of vaccine YF-VAX (lot UI6688AA and Exp. Date 04-JAN-2019) via intramuscular route in the right arm on 07-Jan-2019. The patient's medical history not reported and concomitant medications included MMR and MENACTRA for Immunisation. It was an actual medication error case due to expired vaccine used. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Drug hypersensitivity
Clinical narrative: Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from Health Authorities of country under reference W824444. This case involves an unknown age female patient who experienced allergies to sulfa, while she received vaccine TETANUS TOXOID and while treated with LYRICA. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medication was not reported. On an unknown date, the patient started taking LYRICA dosage unknown (with an unknown batch number) for Neuralgia. On an unknown date, the patient received a dose of suspect TETANUS TOXOID produced by unknown manufacturer lot number not reported. On an unknown date, the patient developed a non-serious allergies sulfa (drug hypersensitivity) <<Unknown latency>> following the first dose intake and <<Unknown latency>> following the last dose intake of LYRICA. The patient developed a non-serious allergies sulfa (drug hypersensitivity) <<Unknown latency>> following the administration of TETANUS TOXOID. (Other relevant tests included No lab data reported.) Final diagnosis was allergies sulfa. LYRICA was unknown. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for allergies sulfa.
Sex: U
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Initial information received on 24-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves Adult patient who received a pediatric dose of vaccine FLUZONE QUADRIVALENT. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. This is a case of vaccine underdose. List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, HEPA, IPV, MMR
Symptoms: Extra dose administered
Clinical narrative: Initial information received on 25-Jan-2019 regarding an unsolicited valid non-serious case received from a nurse. This case involves a five years old female patient who received QUADRACEL (lot C5325BA and Exp. Date 14-Nov-2019) as her fourth IPOL dose and in addition got a separate vaccination of IPOL (lot N1K931M and Exp. Date 18-Nov-2019)via unknown route in the right deltoid on 23-Jan-2019. Patient also received IPOL previously on 28 Feb 2014, 28 April 2014 and on 28 Jul 2015. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included HEPATITIS A VACCINE for Immunisation; and MMR for Immunisation. It was an actual medication error case due extra dose administered. It was reported that that a patient received QUADRACEL on 23Jan2019 which was her fourth IPOL dose. In addition she got a separate vaccination of IPOL making that her fifth dose. It was unknown whether the patient had any adverse reactions. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: Initial information received on 28-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 24 years old female patient who was received vaccine ADACEL lot number U6141AB (Expiry date 15-Dec-2020) via intramuscular route in the left arm on 27-Jan-2019, while she was pregnant. The date of last menstrual period was not reported. The estimated due date was not reported. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was case of vaccine exposure during pregnancy. The patient was 24 months pregnant when she received vaccine. It was reported that no adverse reaction was experienced. Pregnancy outcome was unknown at the time of report. List of documents held by sender- none.
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Initial information received on 28-Jan-2019 regarding an unsolicited valid non-serious case received from Other Health Professional. This case involves a 16 years old female patient who received 0.5 mL dose of vaccine FLUBLOK QIV lot QFAA1831, expiry date:30-Jun-2019 via unknown route in the right deltoid on 27-Dec-2018. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. She did not receive any other immunizations at that time. It was a case of actual medication error due to Inappropriate age at vaccine administration. No adverse effects have been reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by sender: none.
Age: 1.42
Sex: M
Vaccine: DTAPIPV, FLU4, HIBV, PNC
Symptoms: Wrong product administered
Clinical narrative: Initial information received on 29-Jan-2019 regarding an unsolicited valid non-serious case received from another health professional. This case involves a 17 months old male patient who was vaccinated with a 0.5 ml dose of vaccine QUADRACEL instead of DAPTACEL (lot C5497AA and Exp. Date 17-JUL-2020) via unknown route in the left thigh on 16-Jan-2019. The patients medical history not reported. The patient had three DTaP vaccines in the past. Concomitant vaccinations included ACT-HIB; PREVNAR and FLULAVAL for Immunisation. It was an actual medication error case due to wrong vaccine administered. It was unknown whether the patient experienced any adverse event. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: U
Vaccine: TD
Symptoms: Expired product administered
Clinical narrative: Initial information received on 29-Jan-2019 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves an unknown demographic patient who was vaccinated with an expired dose of TENIVAC (batch number, expiration date 7 Jan 2019, dose, route and site of administration was not reported for both vaccines) on 29-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It is an actual medication error case due to expired vaccine used. It was reported that the patient had expired TENIVAC vaccine (expiry date: 07Jan2019) on 29Jan2019. It was unknown whether the patient had any harm or not. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 18.0
Sex: M
Vaccine: TD
Symptoms: Expired product administered, No adverse event
Clinical narrative: Initial information received on 30-Jan-2019 regarding an unsolicited valid non-serious case received from a other health professional. This case involves a 18 years old male patient who received expired 0.5 ml TENIVAC (lot number: U5525AA, expiry date: 07-Jan-2019) via unknown route in the right deltoid on 30 Jan 2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On an unknown date, the patient was bitten by a dog (animal bite). Patient did not received any other vaccine. It was an actual medication error due to Expired vaccine used as patient who was bit by a dog last night and received an expired TENIVAC. No adverse event was reported. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.