chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.17
Sex: F
Vaccine: DTAP
Symptoms: Pallor, Pyrexia, Seizure, Unresponsive to stimuli
Clinical narrative: 7pm, fever of 102.5, gave Tylenol and put her to bed. 12:30 am. fever of 105 degrees Fahrenheit. found in her crib with blue lips, pale face, and having a seizure. eyes rolling to the back of the head and unresponsive for a few minutes. then woke and was in a weird state for the next few hours. crying and no sense of where they were, no eye contact.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Patient states he felt sick for 6 weeks after receiving his first dose of the SHINGRIX vaccine.
Age: 59.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Sore arm last for more than 6 weeks and movement limitation.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Nausea, Pyrexia
Clinical narrative: Red, hot spot on arm-feverish-headache-extremely tired- a bit nauseated.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Red, hot spot on arm-feverish-headache-extremely tired- a bit nauseated.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal, Middle insomnia, Pruritus, Pyrexia
Clinical narrative: She started feeling bad with chills and fever and stayed in bed the day after receiving the vaccine. The rash started on her chest almost 24 hours post vaccination (around 5PM). She woke up in the middle of the night to find the rash had rapidly spread up to her neck and down to her knees (not on face). It did not ever itch or burn. After seeing a doctor, he/she said it looked like hives. The rash resolved by Sunday (5 days post vaccination). She says only since it has gone away has her skin been itchy.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: She started feeling bad with chills and fever and stayed in bed the day after receiving the vaccine. The rash started on her chest almost 24 hours post vaccination (around 5PM). She woke up in the middle of the night to find the rash had rapidly spread up to her neck and down to her knees (not on face). It did not ever itch or burn. After seeing a doctor, he/she said it looked like hives. The rash resolved by Sunday (5 days post vaccination). She says only since it has gone away has her skin been itchy.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Nausea, Vomiting
Clinical narrative: Extreme nausea and vomiting, pounding headache, and diarrhea.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site induration, Myalgia
Clinical narrative: Chills, arthralgia, myalgia for 12-16 hours, onset 12 hours post vaccine. Very large (3x4 inch) area of redness, induration, and erythema surrounding injection site 60 hours post injection.
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Large amount of small red bumps present on legs, small amount of small red bumps present to upper arms and chest. Areas are very itchy, unrelieved by anti-histamines and cortisone cream.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Severe pain in upper arm and greatly decreased arm mobility for approximately one week after the date of the vaccination; arm mobility one day after the vaccine was approximately 30 before extreme pain; mobility gradually increased over the course of a week. One arm received BEXSERO and one received MENACTRA; GARDASIL 9 was administered in the same arm as one of the meningitis vaccines; both arms experienced similar degrees of incapacitation A doctor was not seen for these symptoms as they were improving, albeit slowly.
Age: 9.0
Sex: M
Vaccine: FLUR4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: FLUBLOK QUAD was adminstered instead of FLUZONE QUAD to a pediatric patient.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye movement disorder, Heart rate increased, Hyperhidrosis, Malaise, Muscle rigidity
Clinical narrative: Patient received first dose of SHINGRIX in right arm intra-muscularly. After the injection he said he did not feel well. His wife said he wasn't really a fan of needles. I then told the patient to sit back in the chair (he was turned sideways so I could inject in his right arm, we were both left-handed).  The patient and his wife spoke for about 2-3 minutes about what she was going to do while he sat and in the pharmacy area to see if he would feel better. After approximately 3 minutes patient's  head dropped down. His wife called his name and grabbed his arm but he didn't respond. His head then went back and his eyes rolled back into his head. His body became somewhat stiff and rigid vs. loose as if he fainted. I immediately picked up the phone and call 911. The patient was breathing but his coloring had gone pale, almost green, and his heart rate was rapid. Before I had finished the call with 911 patient regained consciousness and had no recollection what had just occurred. He was extremely sweaty. The paramedics came took all his vitals, which were normal.  They recommended he be seen at the hospital due to his coloring and the amount of sweat he was producing. Patient said he felt fine and did not want to go.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Musculoskeletal stiffness, Pallor, Posture abnormal, Syncope, Unresponsive to stimuli
Clinical narrative: Patient received first dose of SHINGRIX in right arm intra-muscularly. After the injection he said he did not feel well. His wife said he wasn't really a fan of needles. I then told the patient to sit back in the chair (he was turned sideways so I could inject in his right arm, we were both left-handed).  The patient and his wife spoke for about 2-3 minutes about what she was going to do while he sat and in the pharmacy area to see if he would feel better. After approximately 3 minutes patient's  head dropped down. His wife called his name and grabbed his arm but he didn't respond. His head then went back and his eyes rolled back into his head. His body became somewhat stiff and rigid vs. loose as if he fainted. I immediately picked up the phone and call 911. The patient was breathing but his coloring had gone pale, almost green, and his heart rate was rapid. Before I had finished the call with 911 patient regained consciousness and had no recollection what had just occurred. He was extremely sweaty. The paramedics came took all his vitals, which were normal.  They recommended he be seen at the hospital due to his coloring and the amount of sweat he was producing. Patient said he felt fine and did not want to go.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Site where injection was given - red and swollen - no fever.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Face injury, Haemorrhage, Loss of consciousness
Clinical narrative: Pt. received BOOSTRIX vaccine today (8/19/18). While standing in line at the store w/her mom per manager, pt. pass out and hit her chin on the floor. Pt. was conscious. Bleeding on chin and may require stitches. Bleeding stop and pt. was given super drink. Manager offer to call 911 but Mom said no.
Age: 1.5
Sex: M
Vaccine: DTAP, HIBV, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Rash may be due to viral illness or may be a reaction to vaccine given today. OK to give dose of BENADRYL to see if this helps with rash. Given rash started after vaccine administration may want to consider skin testing prior to next DTaP vaccine.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling, Neck pain
Clinical narrative: Woke up next day with pain in left upper arm and neck, upper arm was swollen and red, from shoulder area to elbow, hours later red splotches appeared. Since then, swelling and redness have improved/almost resolved, but arm is still very sore.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity, Rash macular
Clinical narrative: Woke up next day with pain in left upper arm and neck, upper arm was swollen and red, from shoulder area to elbow, hours later red splotches appeared. Since then, swelling and redness have improved/almost resolved, but arm is still very sore.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Blood pressure increased, Condition aggravated, Decreased appetite, Headache
Clinical narrative: Pt. reaction to second SHINGRIX vaccination, fever, bp increased, pulse oxygen down, headache, loss of appetite, breathing, heart racing, face, hands, feet swelling, body pain, asthma flare up. Saw MD. Gave steroid injection and prednisone by mouth. OK now.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Oxygen saturation decreased, Pain, Palpitations, Peripheral swelling, Pyrexia
Clinical narrative: Pt. reaction to second SHINGRIX vaccination, fever, bp increased, pulse oxygen down, headache, loss of appetite, breathing, heart racing, face, hands, feet swelling, body pain, asthma flare up. Saw MD. Gave steroid injection and prednisone by mouth. OK now.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling face
Clinical narrative: Pt. reaction to second SHINGRIX vaccination, fever, bp increased, pulse oxygen down, headache, loss of appetite, breathing, heart racing, face, hands, feet swelling, body pain, asthma flare up. Saw MD. Gave steroid injection and prednisone by mouth. OK now.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Body temperature increased, Chills, Fatigue, Headache, Hypersomnia
Clinical narrative: Pt was administered SHINGRIX #2 in left deltoid at 9:45 am on Friday, August 18,2018. Pt was observed for 15 minutes post-inoculation. No S/S of adverse reaction were observed. Pt called at about 11:45 am on Monday, August 20, 2018 to state that she had extreme chills and shivering with headache beginning at about 9:00 PM on Friday and continuing through Saturday evening. She reported a peak temperature of 101. Patient states she slept 32 out of 36 hours following the injection. Pt took ADVIL which had no effect. Pt states she feels better as of the morning of Monday, August 20, just fatigued with temperature. Pt states injection site is still sore as of Monday 08/20 am at 11:45.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: Pt was administered SHINGRIX #2 in left deltoid at 9:45 am on Friday, August 18,2018. Pt was observed for 15 minutes post-inoculation. No S/S of adverse reaction were observed. Pt called at about 11:45 am on Monday, August 20, 2018 to state that she had extreme chills and shivering with headache beginning at about 9:00 PM on Friday and continuing through Saturday evening. She reported a peak temperature of 101. Patient states she slept 32 out of 36 hours following the injection. Pt took ADVIL which had no effect. Pt states she feels better as of the morning of Monday, August 20, just fatigued with temperature. Pt states injection site is still sore as of Monday 08/20 am at 11:45.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Pt was administered SHINGRIX #2 in left deltoid at 9:45 am on Friday, August 18,2018. Pt was observed for 15 minutes post-inoculation. No S/S of adverse reaction were observed. Pt called at about 11:45 am on Monday, August 20, 2018 to state that she had extreme chills and shivering with headache beginning at about 9:00 PM on Friday and continuing through Saturday evening. She reported a peak temperature of 101. Patient states she slept 32 out of 36 hours following the injection. Pt took ADVIL which had no effect. Pt states she feels better as of the morning of Monday, August 20, just fatigued with temperature. Pt states injection site is still sore as of Monday 08/20 am at 11:45.
Age: 72.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Fatigue, Hypersomnia, Injection site pain
Clinical narrative: My wife experienced extreme fatigue, requiring 2 full days in bed, mostly sleeping plus severe pain at injection site. Also got PREVENAR 13 in rgt. arm - no problems.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injected limb mobility decreased, Insomnia, Pain in extremity
Clinical narrative: Pain in both arms. Right arm upper continues with decreased range of motion at shoulder. Painful enough at night to keep patient from sleeping.
Age: 5.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Rash erythematous
Clinical narrative: 4 inches x 4 inches erythemalic rash on left thigh, no swelling, not warm to touch and is not itchy. Pt. does not complain of any pain.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Cellulitis, Impetigo, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: 4 year old who developed fever, right arm cellulitis, swelling, and itchiness after having a DTaP vaccine. Patient also had several episodes of vomiting on 8/20/18 and arm was warm to the touch. Mom reports the child had impetigo for 3 weeks about 1 month ago. Not sure if this is related.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Skin warm, Vomiting
Clinical narrative: 4 year old who developed fever, right arm cellulitis, swelling, and itchiness after having a DTaP vaccine. Patient also had several episodes of vomiting on 8/20/18 and arm was warm to the touch. Mom reports the child had impetigo for 3 weeks about 1 month ago. Not sure if this is related.
Age: 17.0
Sex: F
Vaccine: MEN, MENB
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and pain at injection site. No other symptoms.
Age: 65.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Sporadic red rash in patches on different areas of the body starting the day after injections. Patient reported symptoms to us on 8/20/18. Still has red, itchy patches on body.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Loss of consciousness, Pain in extremity, Peripheral swelling, Tenderness, Unresponsive to stimuli
Clinical narrative: This is a spontaneous report from a contactable nurse. A 16-year-old female patient received on 08Aug2018 16:30 first dose of TRUMENBA, (lot S58877, expiry date 01Feb2019), at 0.5 ml single intramuscular in the right deltoid and on 08Aug2018 first dose of MENACTRA, (lot U5984AC, expiry date 14Aug2019) at 0.5 ml single intramuscular in the left deltoid, both for immunisation. Medical history and concomitant medications were none. On 08Aug2018 4:43 PM the patient passed out for at least 2 minutes with outcome of completely recovered on the same date. It was reported that vaccines were administered and five minutes after, she walked off and fainted. On 09Aug2018 subject experienced right arm was painful and swollen that recovered with lasting effects in Aug2018. On 09Aug2018 the patient was seen in the office again, because her arm was painful and significantly swollen. No redness, oozing or anything like that was noted, and it was given in the appropriate muscle. The patient will come back in a week and an ultrasound will be done if necessary. Nurse considered the event of passed out as not serious, while right arm was painful and swollen as serious (medically significant) since she had never seen an arm swollen like that. Nurse also considered the event of right arm was painful and swollen related to meningococcal group b rlp2086 and unrelated to meningococcal vaccine a/c/y/w conj (dip tox). Causality between both vaccines and the event passed out was unknown. Follow-up (10Aug2018): New information received from the same contactable nurse includes: reporter occupation, details of patient, reaction data, info on concomitant medications and medical history, seriousness and causality assessment. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ, MENB, MNQ
Symptoms: Loss of consciousness, Pain in extremity, Peripheral swelling, Syncope
Clinical narrative: This is a spontaneous report from a contactable nurse. A 16-year-old female patient received on 08Aug2018 16:30 first dose of TRUMENBA, (lot S58877, expiry date 01Feb2019), at 0.5 ml single intramuscular in the right deltoid and on 08Aug2018 first dose of MENACTRA, (lot U5984AC, expiry date 14Aug2019) at 0.5 ml single intramuscular in the left deltoid, both for immunisation. Medical history and concomitant medications were none. On 08Aug2018 4:43 PM the patient passed out for at least 2 minutes with outcome of completely recovered on the same date. It was reported that vaccines were administered and five minutes after, she walked off and fainted. On 09Aug2018 subject experienced right arm was painful and swollen that recovered with lasting effects in Aug2018. On 09Aug2018 the patient was seen in the office again, because her arm was painful and significantly swollen. No redness, oozing or anything like that was noted, and it was given in the appropriate muscle. The patient will come back in a week and an ultrasound will be done if necessary. Nurse considered the event of passed out as not serious, while right arm was painful and swollen as serious (medically significant) since she had never seen an arm swollen like that. Nurse also considered the event of right arm was painful and swollen related to meningococcal group b rlp2086 and unrelated to meningococcal vaccine a/c/y/w conj (dip tox). Causality between both vaccines and the event passed out was unknown. Follow-up (10Aug2018): New information received from the same contactable nurse includes: reporter occupation, details of patient, reaction data, info on concomitant medications and medical history, seriousness and causality assessment. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Diarrhoea, Flatulence, Headache, Myalgia, Nausea
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of injection site blisters in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 7th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site blisters, pain in arm, shivering, diarrhea, nausea, tiredness, headache, fever and shoulder pain. On an unknown date, the outcome of the injection site blisters, shivering, diarrhea, nausea, headache, fever and shoulder pain were unknown and the outcome of the pain in arm and tiredness were not recovered/not resolved. It was unknown if the reporter considered the injection site blisters, pain in arm, shivering, diarrhea, nausea, tiredness, headache, fever and shoulder pain to be related to SHINGRIX. Additional information was reported as follows: On 7th August 2018 Tuesday, the patient was vaccinated with a dose of SHINGRIX. Till 11th August 2018, the patient still had severe pain in her arm. The patient experienced slight headache. The patient stated that some of her symptoms improved but feeling tired and sore arm were unresolved. The patient had denied permission to contact their physician. The patient had called back and was angry as no medical advice on how to treat her sore arm was provided. No further information was provided.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Rash
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of injection site blisters in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 7th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site blisters, pain in arm, shivering, diarrhea, nausea, tiredness, headache, fever and shoulder pain. On an unknown date, the outcome of the injection site blisters, shivering, diarrhea, nausea, headache, fever and shoulder pain were unknown and the outcome of the pain in arm and tiredness were not recovered/not resolved. It was unknown if the reporter considered the injection site blisters, pain in arm, shivering, diarrhea, nausea, tiredness, headache, fever and shoulder pain to be related to SHINGRIX. Additional information was reported as follows: On 7th August 2018 Tuesday, the patient was vaccinated with a dose of SHINGRIX. Till 11th August 2018, the patient still had severe pain in her arm. The patient experienced slight headache. The patient stated that some of her symptoms improved but feeling tired and sore arm were unresolved. The patient had denied permission to contact their physician. The patient had called back and was angry as no medical advice on how to treat her sore arm was provided. No further information was provided.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Chills, Diarrhoea, Fatigue, Headache, Injection site vesicles
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of injection site blisters in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 7th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site blisters, pain in arm, shivering, diarrhea, nausea, tiredness, headache, fever and shoulder pain. On an unknown date, the outcome of the injection site blisters, shivering, diarrhea, nausea, headache, fever and shoulder pain were unknown and the outcome of the pain in arm and tiredness were not recovered/not resolved. It was unknown if the reporter considered the injection site blisters, pain in arm, shivering, diarrhea, nausea, tiredness, headache, fever and shoulder pain to be related to SHINGRIX. Additional information was reported as follows: On 7th August 2018 Tuesday, the patient was vaccinated with a dose of SHINGRIX. Till 11th August 2018, the patient still had severe pain in her arm. The patient experienced slight headache. The patient stated that some of her symptoms improved but feeling tired and sore arm were unresolved. The patient had denied permission to contact their physician. The patient had called back and was angry as no medical advice on how to treat her sore arm was provided. No further information was provided.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Nausea, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of injection site blisters in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 7th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site blisters, pain in arm, shivering, diarrhea, nausea, tiredness, headache, fever and shoulder pain. On an unknown date, the outcome of the injection site blisters, shivering, diarrhea, nausea, headache, fever and shoulder pain were unknown and the outcome of the pain in arm and tiredness were not recovered/not resolved. It was unknown if the reporter considered the injection site blisters, pain in arm, shivering, diarrhea, nausea, tiredness, headache, fever and shoulder pain to be related to SHINGRIX. Additional information was reported as follows: On 7th August 2018 Tuesday, the patient was vaccinated with a dose of SHINGRIX. Till 11th August 2018, the patient still had severe pain in her arm. The patient experienced slight headache. The patient stated that some of her symptoms improved but feeling tired and sore arm were unresolved. The patient had denied permission to contact their physician. The patient had called back and was angry as no medical advice on how to treat her sore arm was provided. No further information was provided.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of injection site blisters in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 7th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site blisters, pain in arm, shivering, diarrhea, nausea, tiredness, headache, fever and shoulder pain. On an unknown date, the outcome of the injection site blisters, shivering, diarrhea, nausea, headache, fever and shoulder pain were unknown and the outcome of the pain in arm and tiredness were not recovered/not resolved. It was unknown if the reporter considered the injection site blisters, pain in arm, shivering, diarrhea, nausea, tiredness, headache, fever and shoulder pain to be related to SHINGRIX. Additional information was reported as follows: On 7th August 2018 Tuesday, the patient was vaccinated with a dose of SHINGRIX. Till 11th August 2018, the patient still had severe pain in her arm. The patient experienced slight headache. The patient stated that some of her symptoms improved but feeling tired and sore arm were unresolved. The patient had denied permission to contact their physician. The patient had called back and was angry as no medical advice on how to treat her sore arm was provided. No further information was provided.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Injection site swelling, Injection site vesicles, Musculoskeletal pain, Myalgia, Pain in extremity
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of injection site blisters in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 7th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site blisters, pain in arm, shivering, diarrhea, nausea, tiredness, headache, fever and shoulder pain. On an unknown date, the outcome of the injection site blisters, shivering, diarrhea, nausea, headache, fever and shoulder pain were unknown and the outcome of the pain in arm and tiredness were not recovered/not resolved. It was unknown if the reporter considered the injection site blisters, pain in arm, shivering, diarrhea, nausea, tiredness, headache, fever and shoulder pain to be related to SHINGRIX. Additional information was reported as follows: On 7th August 2018 Tuesday, the patient was vaccinated with a dose of SHINGRIX. Till 11th August 2018, the patient still had severe pain in her arm. The patient experienced slight headache. The patient stated that some of her symptoms improved but feeling tired and sore arm were unresolved. The patient had denied permission to contact their physician. The patient had called back and was angry as no medical advice on how to treat her sore arm was provided. No further information was provided.
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of injection site blisters in a 70-year-old female patient who received SHINGRIX for prophylaxis. On 7th August 2018, the patient received SHINGRIX. In August 2018, less than a week after receiving SHINGRIX, the patient experienced injection site blisters, pain in arm, shivering, diarrhea, nausea, tiredness, headache, fever and shoulder pain. On an unknown date, the outcome of the injection site blisters, shivering, diarrhea, nausea, headache, fever and shoulder pain were unknown and the outcome of the pain in arm and tiredness were not recovered/not resolved. It was unknown if the reporter considered the injection site blisters, pain in arm, shivering, diarrhea, nausea, tiredness, headache, fever and shoulder pain to be related to SHINGRIX. Additional information was reported as follows: On 7th August 2018 Tuesday, the patient was vaccinated with a dose of SHINGRIX. Till 11th August 2018, the patient still had severe pain in her arm. The patient experienced slight headache. The patient stated that some of her symptoms improved but feeling tired and sore arm were unresolved. The patient had denied permission to contact their physician. The patient had called back and was angry as no medical advice on how to treat her sore arm was provided. No further information was provided.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 59-year-old male patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On 4th August 2018, the patient received SHINGRIX (intramuscular) .5 ml. In August 2018, several days after receiving SHINGRIX, the patient experienced erythema and pruritus. On an unknown date, the outcome of the erythema and pruritus were not recovered/not resolved. It was unknown if the reporter considered the erythema and pruritus to be related to SHINGRIX. Additional details reported as follows: A few days after vaccination the patient experienced erythema, itching, and redness. The adverse events had gotten worse and the area of redness and itchiness had gotten larger. On follow-up call to healthcare professional, learned that patient had since informed the healthcare professional that he went to urgent care for his symptoms, where he was told by the clinician that this event was normal for this vaccine. The reported batch number 957Z3 for SHINGRIX did not exist and was updated to 957J3 as per the sales database.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema in a 59-year-old male patient who received SHINGRIX (batch number 957J3, expiry date 15th November 2020) for prophylaxis. On 4th August 2018, the patient received SHINGRIX (intramuscular) .5 ml. In August 2018, several days after receiving SHINGRIX, the patient experienced erythema and pruritus. On an unknown date, the outcome of the erythema and pruritus were not recovered/not resolved. It was unknown if the reporter considered the erythema and pruritus to be related to SHINGRIX. Additional details reported as follows: A few days after vaccination the patient experienced erythema, itching, and redness. The adverse events had gotten worse and the area of redness and itchiness had gotten larger. On follow-up call to healthcare professional, learned that patient had since informed the healthcare professional that he went to urgent care for his symptoms, where he was told by the clinician that this event was normal for this vaccine. The reported batch number 957Z3 for SHINGRIX did not exist and was updated to 957J3 as per the sales database.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Fall, Injury, Oral pain, Pain in extremity, Pain in jaw
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative referring to an 11 year old female patient. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On 09-AUG-2018, the patient was vaccinated with a total of three vaccines which included GARDASIL 9 (strength, dose, route of administration, lot # and expiry date were not reported); MENVEO (strength, dose, route of administration, lot # and expiry date were not reported) and Tdap (strength, dose, route of administration, lot # and expiry date were not reported) for prophylaxis. GARDASIL 9 was given last to the patient. On 09-AUG-2018 (10 minutes after vaccines were given), the patient became "dizzy and fell off exam table hitting her head on floor". The patient was taken to an unspecified local hospital emergency room (ER) to be evaluated and was diagnosed with broken jaw and a fractured tooth, who had follow up appointments scheduled. The patient was given treatment for the events. It was unknown if any lab diagnostics/studies were performed. It was unknown whether the patient received any intervention to prevent serious criteria. The outcome of jaw fracture, head injury, dizziness and tooth fracture was reported as recovering/resolving. The reporting nurse did not provide the causality assessment for the events. There was no product quality complaint (PQC) involved. Upon internal review, the event jaw fracture was determined to be medically significant.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative referring to an 11 year old female patient. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On 09-AUG-2018, the patient was vaccinated with a total of three vaccines which included GARDASIL 9 (strength, dose, route of administration, lot # and expiry date were not reported); MENVEO (strength, dose, route of administration, lot # and expiry date were not reported) and Tdap (strength, dose, route of administration, lot # and expiry date were not reported) for prophylaxis. GARDASIL 9 was given last to the patient. On 09-AUG-2018 (10 minutes after vaccines were given), the patient became "dizzy and fell off exam table hitting her head on floor". The patient was taken to an unspecified local hospital emergency room (ER) to be evaluated and was diagnosed with broken jaw and a fractured tooth, who had follow up appointments scheduled. The patient was given treatment for the events. It was unknown if any lab diagnostics/studies were performed. It was unknown whether the patient received any intervention to prevent serious criteria. The outcome of jaw fracture, head injury, dizziness and tooth fracture was reported as recovering/resolving. The reporting nurse did not provide the causality assessment for the events. There was no product quality complaint (PQC) involved. Upon internal review, the event jaw fracture was determined to be medically significant.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP, HPV9, MNQ, TDAP
Symptoms: Dizziness, Fall, Head injury, Jaw fracture, Tooth fracture
Clinical narrative: This spontaneous report was received from a registered nurse via a company representative referring to an 11 year old female patient. Information on patient's pertinent medical history, drug reactions/allergies and concomitant therapies were not reported. On 09-AUG-2018, the patient was vaccinated with a total of three vaccines which included GARDASIL 9 (strength, dose, route of administration, lot # and expiry date were not reported); MENVEO (strength, dose, route of administration, lot # and expiry date were not reported) and Tdap (strength, dose, route of administration, lot # and expiry date were not reported) for prophylaxis. GARDASIL 9 was given last to the patient. On 09-AUG-2018 (10 minutes after vaccines were given), the patient became "dizzy and fell off exam table hitting her head on floor". The patient was taken to an unspecified local hospital emergency room (ER) to be evaluated and was diagnosed with broken jaw and a fractured tooth, who had follow up appointments scheduled. The patient was given treatment for the events. It was unknown if any lab diagnostics/studies were performed. It was unknown whether the patient received any intervention to prevent serious criteria. The outcome of jaw fracture, head injury, dizziness and tooth fracture was reported as recovering/resolving. The reporting nurse did not provide the causality assessment for the events. There was no product quality complaint (PQC) involved. Upon internal review, the event jaw fracture was determined to be medically significant.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Back pain, Dyspnoea, Hypertension, Nausea
Clinical narrative: Shortness of breath, nausea, pain in lower back, high blood pressure--lasted 10-15mins. and resolved by itself. Paramedics came, assessed him, took his blood pressure and said he could go home if he wanted. He declined need to go to hospital. He stated he felt back to normal and went home.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram head, Vertigo
Clinical narrative: One week after the injection of SHINGRIX, at Pharmacy. I experienced severe vertigo and phoned 911 for emergency transport to Medical Center. A CT scan  of head was done and I eventually was given ANTIVERT PO 25 mg Tab. After 4-5 hours I was sent home with a prescription for same and instructions to see my primary physician. I saw Dr. the same day in the afternoon. I do not know but I wonder if the vertigo was caused by SHINRIX and if the 2nd dose should be administered.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Ultrasound antenatal screen normal
Clinical narrative: Information has been received from an obstetrician-gynecologist, for HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast), a Pregnancy Registry product, concerning an approximately 21-year-old Caucasian female patient. The patient had no significant past medical history, no concurrent medical conditions and no obstetric history. The patient's last menstrual period was reported to be on 19-MAY-2018. On 01-JUN-2018, the patient was vaccinated with the second dose of GARDASIL 9 (lot # R000301) for prophylaxis. On approximately 02-JUN-2018, the patient conceived (exposure during pregnancy). The estimated date of delivery (EDD) was reported to be 23-FEB-2019. On 03-AUG-2018, the patient underwent an ultrasound test as she was dating and received a result confirming a single live intrauterine pregnancy (IUP). The patient's other medication included prenatal vitamins taken daily.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 4-year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date, the patient was vaccinated with improperly stored doses of VARIVAX subcutaneously, lot # N026073 with expiration date on 20-SEP-2019 (dose and site of administration were not reported) and M-M-R II subcutaneously, lot # N023150 with expiration date on 24-AUG-2019, and lot # N011005 with expiration date on 05-APR-2019 (dose and site of administration were not reported) for prophylaxis. Administered doses of VARIVAX experienced the temperature excursion of 8.3 degrees Celsius for 1 hour 23 minutes. Administered doses of M-M-R II experienced the temperature excursion of 9.5 degrees Celsius for 1 hour 36 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter.; Sender's Comments: US-009507513-1808USA004566: US-009507513-1808USA002162: US-009507513-1808USA004565:
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a currently 4-year old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On an unknown date, the patient was vaccinated with improperly stored doses of Oka/Merck VARIVAX subcutaneously, lot # N026073 with expiration date on 20-SEP-2019 (dose and site of administration were not reported) and (wistar ra 27-3) M-M-R II subcutaneously, lot # N023150 with expiration date on 24-AUG-2019 and lot # N011005 with expiration date on 05-APR-2019 (dose and site of administration were not reported) for prophylaxis. Administered doses of Ooka/Merck VARIVAX experienced the temperature excursion of 8.3 degrees Celsius for 1 hour 23 minutes. Administered doses of (wistar ra 27-3) M-M-R II experienced the temperature excursion of 9.5 degrees Celsius for 1 hour 36 minutes. Data logger was involved. There were no previous excursions reported. No adverse effects were reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1808USA004564: US-009507513-1808USA004566: US-009507513-1808USA002162.
Sex: M
Vaccine: VARCEL
Symptoms: Contraindication to vaccination
Clinical narrative: Information has been received from a physician referring to a male patient (reported as teenager) with medical history of inflammatory bowel disease and had no drug allergy. Concomitant therapies included HUMIRA. On 09-AUG-2018, the patient was vaccinated with Oak/Merck VARIVAX (indication reported as requirement for camp; dose, route, lot # and expiration date were not reported) for prophylaxis. On 09-AUG-2018, after administration of Oak/Merck VARIVAX the patient was hospitalized. On 09-AUG-2018, the physician reported that the patient was started on acyclovir therapy (dose unknown by reporter) for unspecified reason. None lab diagnostics/studies were performed. At the reporting time, the outcome of the event was not recovered. The causality was not provided.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a nurse, referring to a patient (gender and age unknown). Information about medical history, concurrent condition and concomitant therapy was unknown. On 14-AUG-2018, the patient was vaccinated with M-M-R II injection (dose, route, strength and frequency unknown; lot # M035935, expiration date: 09-AUG-2018, therapy type: recombinant Human albumin (rHA)) for prophylaxis (expired product administered). The M-M-R II did not have any previous temperature excursions prior to administration. No adverse symptoms reported.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a 16 year old male patient. The patient's historical condition included anaphylactic reaction to a vaccine component. On 06-AUG-2018 the patient was vaccinated with improperly stored GARDASIL 9 lot # R001262 dose 3 in the left deltoid for prophylaxis (product storage error). The patient did not have any reverse reactions to the vaccine. No adverse events reported.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Post herpetic neuralgia
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. On or about 29-DEC-2014, the patient was vaccinated with ZOSTAVAX, (lot# and route unknown) for routine adult health maintenance and the intended purpose of long-term prevention of shingles and zoster-related injuries. The vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster. On or about 11-SEP-2017, the patient was treated by a physician assistant for herpes zoster, or shingles. On 30-SEP-2017, the patient was diagnosed with post herpetic neuralgia and other zoster-related injuries, and he was prescribed medication for management of his painful symptoms. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX, for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 14-AUG-2018, the patient was vaccinated with improperly stored doses of GARDASIL 9 (lot # R000301, Expiry date : 29-AUG-2020) 1 DF for prophylaxis (product storage error). Temperature was reported as 20 F and time frame was 5 days. There was no previous temperature excursion. The call was due to data logger. There was no adverse effects were reported. No product quality complaint was involved. This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-1808USA007503:
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Malaise, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via out of hour services and described the occurrence of headache in a 72-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Previously administered products included Zostavax (injection).  On 17th July 2018, the patient received SHINGRIX. On 18th July 2018, 1 days after receiving SHINGRIX, the patient experienced headache, upset stomach, general body pain and fever. On 19th July 2018, the patient experienced feeling unwell. On an unknown date, the outcome of the headache, upset stomach, general body pain, fever and feeling unwell were recovered/resolved. It was unknown if the reporter considered the headache, upset stomach, general body pain, fever and feeling unwell to be related to SHINGRIX. Additional details were provided as follows: The patient reported that the next morning after receiving a SHINGRIX dose, she experienced headache, fever (body temperature was recorded as 101.3 degree F), aches all over, and an upset stomach. The patient feeling betting, 2 days after receiving a dose of SHINGRIX. At time of reporting, all events have resolved. The patient provided there physician's details.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included eczema. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was recovered/resolved. Additional details were provided as follows:  The age at vaccination was not reported. The patient received SHINGRIX and experienced a big rash on her arm and all the way down to her leg. The pharmacist said that this reaction was really abnormal. She did not know if it was an exacerbation of her eczema. Event was resolved and the patient came in for her second dose.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of influenza-like symptoms in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was reported as follows: The age at vaccination was not reported. The patient experienced flu-like symptoms after receiving SHINGRIX, had to stay in bed for two days to recover.