chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Concussion, Emotional distress, Fall, Head injury, Headache
Clinical narrative: Concussion; Syncopal event; Emotional distress; Fall; Forehead swelling; Headache; Swelling; Head injury; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act on (VAERS # 805476-1) on 04-OCT-2019.  This spontaneous report was received from a healthcare professional and refers to a non-pregnant 14 year old female patient with no allergies to medications, food or other products, no other illnesses at the vaccination time, and no chronic or long-standing health conditions. The patient did not have an adverse event following any previous vaccine. No information about the patient's concomitant medications was provided.      On 13-MAR-2019 16:20, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R009614 with expiration date of 30-NOV-2020, intramuscularly in the left arm (LA) for prophylaxis.        On 13-MAR-2019 16:20, about 10 min after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was given, staff heard a yell for help. The patient was lying on the floor holding her head, her mom said she turned around for a min, then as she turned, child fell from the table. Seemed to hit her body first then head on the floor. Patient was examined by physician, Ice was applied to her head. She had a small lump on the left side of forehead and swollen bridge of her nose. She stated she had a headache. No nausea or dizziness. She did not remember falling. The physician wanted to get her on the table and keep her for a while. Patient was upset and wanted to go home. She stayed for about 15 minutes more while sitting on the floor. We got her up, physician walked her to check out, and asked if she needed help to the car, mom said "No, l've got her." Patient was being seen again on 14-MAR-2019 for a follow up (no further information). The outcome of emotional distress, swelling, headache, head injury, swelling face and fall was reported as not resolved.  The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Follow-up information was received from physician on 04-NOV-2019. The patient demographics was updated. On an unknown date, the patient experienced syncope and concussion. The outcome of syncope and concussion were unknown. The reporter considered the events head injury, syncope and concussion to be related with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).No Product Quality Complaint (PQC) was involved.  The reporter considered the events syncopal event, head injury and concussion to be medically significant.
Age: 14.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Mass, Swelling face, Syncope
Clinical narrative: Concussion; Syncopal event; Emotional distress; Fall; Forehead swelling; Headache; Swelling; Head injury; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act on (VAERS # 805476-1) on 04-OCT-2019.  This spontaneous report was received from a healthcare professional and refers to a non-pregnant 14 year old female patient with no allergies to medications, food or other products, no other illnesses at the vaccination time, and no chronic or long-standing health conditions. The patient did not have an adverse event following any previous vaccine. No information about the patient's concomitant medications was provided.      On 13-MAR-2019 16:20, the patient was vaccinated with her first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot # R009614 with expiration date of 30-NOV-2020, intramuscularly in the left arm (LA) for prophylaxis.        On 13-MAR-2019 16:20, about 10 min after hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was given, staff heard a yell for help. The patient was lying on the floor holding her head, her mom said she turned around for a min, then as she turned, child fell from the table. Seemed to hit her body first then head on the floor. Patient was examined by physician, Ice was applied to her head. She had a small lump on the left side of forehead and swollen bridge of her nose. She stated she had a headache. No nausea or dizziness. She did not remember falling. The physician wanted to get her on the table and keep her for a while. Patient was upset and wanted to go home. She stayed for about 15 minutes more while sitting on the floor. We got her up, physician walked her to check out, and asked if she needed help to the car, mom said "No, l've got her." Patient was being seen again on 14-MAR-2019 for a follow up (no further information). The outcome of emotional distress, swelling, headache, head injury, swelling face and fall was reported as not resolved.  The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Follow-up information was received from physician on 04-NOV-2019. The patient demographics was updated. On an unknown date, the patient experienced syncope and concussion. The outcome of syncope and concussion were unknown. The reporter considered the events head injury, syncope and concussion to be related with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9).No Product Quality Complaint (PQC) was involved.  The reporter considered the events syncopal event, head injury and concussion to be medically significant.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia
Clinical narrative: Severe joint pain - symptoms have just resolved within the last week.
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Erythema, Injection site extravasation, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: I got cellulitis; I couldn't move my arm that evening or sleep.; I couldn't move my arm that evening or sleep; I missed three days of work; my arm swelled up really bad; received a pneumonia  shot last year and got it again this year; This spontaneous report was received from a 60-year-old female patient referring to herself. The patient's concomitant medication included calcium (unspecified), vilazodone hydrochloride (VIIBRYD), imipramine, simvastatin, pantoprazole and fiber (unspecified). The patient had no pertinent medical history and drug reactions/allergies.  In 2018 the patient received Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). On 08-OCT-2019 the patient was vaccinated again with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (single shot in her arm; dose, route, lot # and the expiration date were not reported) for prevention of pneumonia (inappropriate schedule of vaccine administered).  On 08-OCT-2019, the night she got the shot, her arm swelled up really bad. She got cellulitis. She couldn't move her arm that evening or sleep. She missed three days of work. She visited her doctor and received treatment of antibiotics for 7 days. No lab diagnostics/studies were performed.  Outcome of "missed work" was recovered on 11-OCT-2019. Outcome of other events was recovered in the morning of 12-OCT-2019. The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported.  Upon internal review, cellulitis was determined to be medically significant.
Sex: F
Vaccine: PPV, PPV
Symptoms: Pain, Pain in extremity, Peripheral swelling
Clinical narrative: I got cellulitis; I couldn't move my arm that evening or sleep.; I couldn't move my arm that evening or sleep; I missed three days of work; my arm swelled up really bad; received a pneumonia  shot last year and got it again this year; This spontaneous report was received from a 60-year-old female patient referring to herself. The patient's concomitant medication included calcium (unspecified), vilazodone hydrochloride (VIIBRYD), imipramine, simvastatin, pantoprazole and fiber (unspecified). The patient had no pertinent medical history and drug reactions/allergies.  In 2018 the patient received Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). On 08-OCT-2019 the patient was vaccinated again with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (single shot in her arm; dose, route, lot # and the expiration date were not reported) for prevention of pneumonia (inappropriate schedule of vaccine administered).  On 08-OCT-2019, the night she got the shot, her arm swelled up really bad. She got cellulitis. She couldn't move her arm that evening or sleep. She missed three days of work. She visited her doctor and received treatment of antibiotics for 7 days. No lab diagnostics/studies were performed.  Outcome of "missed work" was recovered on 11-OCT-2019. Outcome of other events was recovered in the morning of 12-OCT-2019. The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported.  Upon internal review, cellulitis was determined to be medically significant.
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis, Impaired work ability, Inappropriate schedule of product administration, Insomnia, Mobility decreased
Clinical narrative: I got cellulitis; I couldn't move my arm that evening or sleep.; I couldn't move my arm that evening or sleep; I missed three days of work; my arm swelled up really bad; received a pneumonia  shot last year and got it again this year; This spontaneous report was received from a 60-year-old female patient referring to herself. The patient's concomitant medication included calcium (unspecified), vilazodone hydrochloride (VIIBRYD), imipramine, simvastatin, pantoprazole and fiber (unspecified). The patient had no pertinent medical history and drug reactions/allergies.  In 2018 the patient received Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). On 08-OCT-2019 the patient was vaccinated again with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (single shot in her arm; dose, route, lot # and the expiration date were not reported) for prevention of pneumonia (inappropriate schedule of vaccine administered).  On 08-OCT-2019, the night she got the shot, her arm swelled up really bad. She got cellulitis. She couldn't move her arm that evening or sleep. She missed three days of work. She visited her doctor and received treatment of antibiotics for 7 days. No lab diagnostics/studies were performed.  Outcome of "missed work" was recovered on 11-OCT-2019. Outcome of other events was recovered in the morning of 12-OCT-2019. The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported.  Upon internal review, cellulitis was determined to be medically significant.
Sex: F
Vaccine: PPV, PPV
Symptoms: Peripheral swelling
Clinical narrative: I got cellulitis; I couldn't move my arm that evening or sleep.; I couldn't move my arm that evening or sleep; I missed three days of work; my arm swelled up really bad; received a pneumonia  shot last year and got it again this year; This spontaneous report was received from a 60-year-old female patient referring to herself. The patient's concomitant medication included calcium (unspecified), vilazodone hydrochloride (VIIBRYD), imipramine, simvastatin, pantoprazole and fiber (unspecified). The patient had no pertinent medical history and drug reactions/allergies.  In 2018 the patient received Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). On 08-OCT-2019 the patient was vaccinated again with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) injection (single shot in her arm; dose, route, lot # and the expiration date were not reported) for prevention of pneumonia (inappropriate schedule of vaccine administered).  On 08-OCT-2019, the night she got the shot, her arm swelled up really bad. She got cellulitis. She couldn't move her arm that evening or sleep. She missed three days of work. She visited her doctor and received treatment of antibiotics for 7 days. No lab diagnostics/studies were performed.  Outcome of "missed work" was recovered on 11-OCT-2019. Outcome of other events was recovered in the morning of 12-OCT-2019. The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not reported.  Upon internal review, cellulitis was determined to be medically significant.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Lethargy, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Soreness to her arm; Headaches; Could not use arms or legs; Could not speak; could not use walker; was literally paralyzed; Both legs gave out; Kept Collapsing; This case was reported by a consumer via call center representative and described the occurrence of paralyzed in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2019, the patient received the 1st dose of Shingrix. On 1st November 2019, 3 days after receiving Shingrix, the patient experienced paralyzed (serious criteria GSK medically significant), loss of control of legs (serious criteria GSK medically significant) and faint (serious criteria GSK medically significant). On 2nd November 2019, the patient experienced weakness in extremity, speech disorder and walking difficulty. On 3rd November 2019, the patient experienced headache. On an unknown date, the patient experienced pain in arm. On 2nd November 2019, the outcome of the weakness in extremity was resolved with sequelae. On 3rd November 2019, the outcome of the paralyzed, loss of control of legs, faint, speech disorder and walking difficulty were resolved with sequelae. On 4th November 2019, the outcome of the headache was resolved with sequelae. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the paralyzed, loss of control of legs, faint, pain in arm, weakness in extremity, speech disorder, walking difficulty and headache to be related to Shingrix.  Additional details were provided as follows:  The patient reported for herself. The patient received Shingrix in the left arm. Less than a week of vaccination, the patient had some soreness to her arm which she said was no big deal. On Friday evening, both of her legs gave out and she kept collapsing and her husband had to help her to bed. Then 4 days later in the daytime on Saturday, the patient could not use her arms or legs and could not speak. She stated, this lasted about 15 minutes to a half hour. She had a walker nearby but she could not use it. The patient stated, she was literally paralyzed.  On Saturday night, the patient was okay and on Sunday, after 5 days of vaccination, she had headaches. On the day of reporting, the patient was feeling good. The patient also reported that, her pharmacist told her that some people were bedridden for a couple days after having the vaccine and that she had friends that were real sick for a while after the vaccine but she did not have any additional specifics or information on these two reports. The patient would not be having the 2nd dose of Shingrix vaccine. She stated, she had not followed up with her physician yet but that she would. The patient consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Gait disturbance, Headache, Loss of control of legs, Muscular weakness, Musculoskeletal disorder
Clinical narrative: Soreness to her arm; Headaches; Could not use arms or legs; Could not speak; could not use walker; was literally paralyzed; Both legs gave out; Kept Collapsing; This case was reported by a consumer via call center representative and described the occurrence of paralyzed in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2019, the patient received the 1st dose of Shingrix. On 1st November 2019, 3 days after receiving Shingrix, the patient experienced paralyzed (serious criteria GSK medically significant), loss of control of legs (serious criteria GSK medically significant) and faint (serious criteria GSK medically significant). On 2nd November 2019, the patient experienced weakness in extremity, speech disorder and walking difficulty. On 3rd November 2019, the patient experienced headache. On an unknown date, the patient experienced pain in arm. On 2nd November 2019, the outcome of the weakness in extremity was resolved with sequelae. On 3rd November 2019, the outcome of the paralyzed, loss of control of legs, faint, speech disorder and walking difficulty were resolved with sequelae. On 4th November 2019, the outcome of the headache was resolved with sequelae. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the paralyzed, loss of control of legs, faint, pain in arm, weakness in extremity, speech disorder, walking difficulty and headache to be related to Shingrix.  Additional details were provided as follows:  The patient reported for herself. The patient received Shingrix in the left arm. Less than a week of vaccination, the patient had some soreness to her arm which she said was no big deal. On Friday evening, both of her legs gave out and she kept collapsing and her husband had to help her to bed. Then 4 days later in the daytime on Saturday, the patient could not use her arms or legs and could not speak. She stated, this lasted about 15 minutes to a half hour. She had a walker nearby but she could not use it. The patient stated, she was literally paralyzed.  On Saturday night, the patient was okay and on Sunday, after 5 days of vaccination, she had headaches. On the day of reporting, the patient was feeling good. The patient also reported that, her pharmacist told her that some people were bedridden for a couple days after having the vaccine and that she had friends that were real sick for a while after the vaccine but she did not have any additional specifics or information on these two reports. The patient would not be having the 2nd dose of Shingrix vaccine. She stated, she had not followed up with her physician yet but that she would. The patient consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Paralysis, Speech disorder, Syncope
Clinical narrative: Soreness to her arm; Headaches; Could not use arms or legs; Could not speak; could not use walker; was literally paralyzed; Both legs gave out; Kept Collapsing; This case was reported by a consumer via call center representative and described the occurrence of paralyzed in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2019, the patient received the 1st dose of Shingrix. On 1st November 2019, 3 days after receiving Shingrix, the patient experienced paralyzed (serious criteria GSK medically significant), loss of control of legs (serious criteria GSK medically significant) and faint (serious criteria GSK medically significant). On 2nd November 2019, the patient experienced weakness in extremity, speech disorder and walking difficulty. On 3rd November 2019, the patient experienced headache. On an unknown date, the patient experienced pain in arm. On 2nd November 2019, the outcome of the weakness in extremity was resolved with sequelae. On 3rd November 2019, the outcome of the paralyzed, loss of control of legs, faint, speech disorder and walking difficulty were resolved with sequelae. On 4th November 2019, the outcome of the headache was resolved with sequelae. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the paralyzed, loss of control of legs, faint, pain in arm, weakness in extremity, speech disorder, walking difficulty and headache to be related to Shingrix.  Additional details were provided as follows:  The patient reported for herself. The patient received Shingrix in the left arm. Less than a week of vaccination, the patient had some soreness to her arm which she said was no big deal. On Friday evening, both of her legs gave out and she kept collapsing and her husband had to help her to bed. Then 4 days later in the daytime on Saturday, the patient could not use her arms or legs and could not speak. She stated, this lasted about 15 minutes to a half hour. She had a walker nearby but she could not use it. The patient stated, she was literally paralyzed.  On Saturday night, the patient was okay and on Sunday, after 5 days of vaccination, she had headaches. On the day of reporting, the patient was feeling good. The patient also reported that, her pharmacist told her that some people were bedridden for a couple days after having the vaccine and that she had friends that were real sick for a while after the vaccine but she did not have any additional specifics or information on these two reports. The patient would not be having the 2nd dose of Shingrix vaccine. She stated, she had not followed up with her physician yet but that she would. The patient consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Rash
Clinical narrative: scars on right shoulder are tender; redness at injection site; injection site feels hot; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shoulder operation (had shoulder surgery 2 years ago). Concurrent medical conditions included scar (had scar on right shoulder).   On 30th October 2019, the patient received the 1st dose of Shingrix. On 30th October 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On 4th November 2019, the patient experienced scar pain. On an unknown date, the outcome of the injection site erythema, injection site warmth and scar pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and scar pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received dose of Shingrix in the right arm. The reporter stated that later on the same day after receiving vaccine, she had redness at the injection site and the injection site feels hot. The patient reported that, over the weekend, the redness seemed to be improving and on the day of reporting the redness was worse and was approximately the size of a slice of bread. The patient stated that, had surgery on the shoulder approximately 2 years ago and the scars from the surgery were little tender on the day of reporting (5 days after vaccination). The reporter consented to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site warmth, Scar pain
Clinical narrative: scars on right shoulder are tender; redness at injection site; injection site feels hot; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shoulder operation (had shoulder surgery 2 years ago). Concurrent medical conditions included scar (had scar on right shoulder).   On 30th October 2019, the patient received the 1st dose of Shingrix. On 30th October 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema and injection site warmth. On 4th November 2019, the patient experienced scar pain. On an unknown date, the outcome of the injection site erythema, injection site warmth and scar pain were not recovered/not resolved.   It was unknown if the reporter considered the injection site erythema, injection site warmth and scar pain to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient received dose of Shingrix in the right arm. The reporter stated that later on the same day after receiving vaccine, she had redness at the injection site and the injection site feels hot. The patient reported that, over the weekend, the redness seemed to be improving and on the day of reporting the redness was worse and was approximately the size of a slice of bread. The patient stated that, had surgery on the shoulder approximately 2 years ago and the scars from the surgery were little tender on the day of reporting (5 days after vaccination). The reporter consented to follow up.
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Aphasia, Bruxism, Chills, Clumsiness, Constipation
Clinical narrative: She was swollen they gave her 7 shots multiple on each arm and leg  she had high pitch screams right after gettin them took her home and she slept the whole day she woke up different she threw up , had high fevers , chills she couldn?t poop but when she finally did she had bloody poop , she wouldn?t react anymore or give eye contact she stopped talking started banging her head on anything she could find , she stopped walking and started to be clumsy and bump into everything , she started grinding her teeth .
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Decreased eye contact, Gait inability, Haematochezia, Head banging, Hypersomnia
Clinical narrative: She was swollen they gave her 7 shots multiple on each arm and leg  she had high pitch screams right after gettin them took her home and she slept the whole day she woke up different she threw up , had high fevers , chills she couldn?t poop but when she finally did she had bloody poop , she wouldn?t react anymore or give eye contact she stopped talking started banging her head on anything she could find , she stopped walking and started to be clumsy and bump into everything , she started grinding her teeth .
Age: 1.0
Sex: F
Vaccine: DTAP, HEPA, HIBV, IPV, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Screaming, Swelling, Unresponsive to stimuli, Vomiting
Clinical narrative: She was swollen they gave her 7 shots multiple on each arm and leg  she had high pitch screams right after gettin them took her home and she slept the whole day she woke up different she threw up , had high fevers , chills she couldn?t poop but when she finally did she had bloody poop , she wouldn?t react anymore or give eye contact she stopped talking started banging her head on anything she could find , she stopped walking and started to be clumsy and bump into everything , she started grinding her teeth .
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Gingival bleeding, Haemorrhage, Lip swelling, Oral pain
Clinical narrative: Woke up with severe overall mouth pain and swollen lips and cheeks. Was wearing a night guard as I have for over 3 months with no issues. It was very painful to remove the guard, my gums and cheeks were bleeding.  The skin on my gums and cheeks were bright red, hot, swollen, painful to touch and the skin was sloughing; like peeling from sunburn. I rinsed with Dry Mouth Smart Mouth, warm water, couldn't brush my teeth, too painful to open mouth. Saw my dentist and they gave me a pain mouth wash. Only explanation was an acute allergic reaction.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Skin exfoliation, Skin warm, Swelling face
Clinical narrative: Woke up with severe overall mouth pain and swollen lips and cheeks. Was wearing a night guard as I have for over 3 months with no issues. It was very painful to remove the guard, my gums and cheeks were bleeding.  The skin on my gums and cheeks were bright red, hot, swollen, painful to touch and the skin was sloughing; like peeling from sunburn. I rinsed with Dry Mouth Smart Mouth, warm water, couldn't brush my teeth, too painful to open mouth. Saw my dentist and they gave me a pain mouth wash. Only explanation was an acute allergic reaction.
Age: 10.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Throat tightness
Clinical narrative: Vaccine was a GSK influenza vaccine, distributed by ID BioMedical. If it was a quadrivalent or trivalent, and lot number unknown by me. A 4 inch long swelling occurred on the arm below the injection site, as well as throat tightening. Swelling was red and hot to the touch.  Called the Doctor's office on 11/6/19 and was advised by doctor's office staff to  use ice, Motrin, and Benadryl until symptoms subsided. As of 11/11/19, the site is still slightly red, but swelling has decreased.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site cellulitis
Clinical narrative: cellulitis at injection site
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product quality issue
Clinical narrative: No adverse effects reported; a package with a product quality issue where there were markings on the outside of the syringe; a patient received one dose of PNEUMOVAX 23 from a package with a product quality issue where there were markings on the outside of the syringe; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. Information on concomitant medication, pertinent medical history and drug reactions/allergies was not provided.  On 16-OCT-2019 the patient received one dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (lot # R017900 with expiration date 26-MAR-2020; dose and frequency were not reported) intramuscularly for prophylaxis from a package with a product quality issue where there were markings on the outside of the syringe(product quality issue and poor quality product administered). No adverse effects were reported.  This is one of two cases received from the same reporter.; Sender's Comments:  US-009507513-1910USA011988:
Sex: U
Vaccine: BCG, BCG
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: unspecified patients were administered BCG vaccine intravesical; No adverse effects reported; This initial spontaneous report originating as received from a healthcare worker referring to unspecified patients of unknown ages and unknown genders. Information about patients' pertinent medical history, drug reactions/allergies and concomitant medication was not reported.  On unknown dates, the patients were vaccinated with bcg live (BCG VACCINE USP) 50mg (dose detail, lot # and expiration date were not reported) via intravesical route for prophylaxis (incorrect route of product administration). No adverse effects were reported. For bcg live (BCG VACCINE USP PUNCTURE DEVICE (DEVICE)), the lot number is not available and the serial number is not available.  This is one of two reports received from the same reporter(linked case # 1910USA02382). combinationproductreport: Yes; brandname: BCG VACCINE USP PUNCTURE DEVICE (DEVICE); commondevicename: BCG live; productcode: LDH; devicetype: SYSTEM, DELIVERY, ALLERGEN AND VACCINE (LDH); deviceage and unit: 0 ; malfunction: No; deviceusage: Unknown; evaluatedbymfr: No; reasonfornoneval: 81 Other; reasonfornonevalother: no information about availability; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; evaluationvalue - Patient / Device: N/A / 1670; Sender's Comments:  US-009507513-1910USA012382:
Sex: U
Vaccine: MMR
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Underdose
Clinical narrative: No adverse effect reported.; child moved while receiving M-M-R II dose today and did not receive a full dose; Information has been received from a nurse, referring to a child of unknown age and gender. Information about medical history, concurrent condition and concomitant therapy was unknown.   On 21-OCT-2019, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) (one dose; strength, route, lot# and expiration date were unknown)  for prophylaxis. The child moved while receiving measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) dose and did not receive a full dose. No adverse effect was reported.
Sex: U
Vaccine: UNK, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects.; a patient was administered a dose of improperly stored VARIVAX; This spontaneous report was received from a nurse referring a patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.    On 14-OCT-2019, a patient administered a dose of improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) (lot # S015460 and expiration date 20-MAY-2021; strength, dose and frequency were not reported) subcutaneously for prophylaxis (product storage error) with sterile diluent (strength, dose, frequency, route, lot #, expiration date and indication were not reported). It could not be determined if the sterile diluent was properly stored. No adverse effects were reported. The vaccine underwent the temperature of -11.5 Celsius for a duration of 76 hours. There was no previous temperature excursion and the call was because of data logger.
Age: 34.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse effect; 34 year old patient was administered one dose of PROQUAD; This spontaneous report was received from a nurse via field representative refers to a 34 year old patient of unknown gender. The patient's medical history, concurrent conditions, historical drugs, drug reactions/ allergies and concomitant medications were not reported. On 21-OCT-2019, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin) (PROQUAD) lot # S003178 and expiration date 30-JUL-2020, (strength, dose, frequency and route not reported) for prophylaxis. The patient's age at vaccination was 34 years (product administered to patient of inappropriate age). No adverse effects reported. No product quality complaint (PQC) was present.
Sex: M
Vaccine: HIBV, PPV
Symptoms: Vaccination failure
Clinical narrative: Poor pneumococcal and HIB vaccine response was noted.; This literature marketed information has been received from the authors in a published article title as stated below.  The authors describe a case from a 71 years old male patient whose concurrent conditions included chronic lymphocytic leukemia (CLL) (11q deletion, immunoglobulin heavy chain unmutated, Rai stage III). Patient was clinically asymptomatic until 2017, when he developed thrombocytopenia and he started infusions with obinutuzumab for two months and went into remission.   On an unknown date the patient was vaccinated with a dose of haemophilus b conjugate vaccine (meningococcal protein conjugate) (manufacturer unknown) (lot #, expiration date, strength, dose, route of administration and anatomical location of vaccine were not reported)  and with a dose of  pneumococcal vaccine, polyvalent (23-valent)(manufacturer unknown) (Lot #, expiration date, strength, dose, route of administration and anatomical location of vaccine were not reported); both vaccine were administered for prophylaxis. On an unknown date, poor pneumococcal and HIB vaccine response was noted. At the reporting time, the outcome was unknown.    A copy of the published article has been requested.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; the patient was administered a dose of PNEUMO VAX 23 which was improperly stored; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant therapies and drug allergy or reactions were not reported.       On 31-OCT-2019, the patient was vaccinated with a dose of improperly stored pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose and route were not reported; lot #: S026366, expiration date: 17-SEP-2020) for prophylaxis (product storage error). The vaccine experienced the following temperature excursion: below 2 degree Celsius: 1.1 Celsius (C) for 10 hours. There were no previous temperature excursions. The digital data logger was involved. No adverse effects were reported. Outcome was reported as supported.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Blood immunoglobulin E normal, Therapeutic response decreased
Clinical narrative: a diminished response to the 23-valent pneumococcal polysaccharide vaccine;   This literature marketed report has been received from the author of a published article titled as stated above referring to a 65-year-old female patient.  The patient was referred from otolaryngology for evaluation of several years of long-standing chronic rhinosinusitis with nasal polyposis (CRS w NP). Her symptoms included mucopurulent drainage, congestion, and facial pain without anosmia. Computed tomography (CT) sinus was notable for septal deviation with opacification of the left frontal, paranasal, maxillary, and ethmoid sinuses. She underwent endoscopic sinus surgery several months prior without significant improvement. Operative cultures grew penicillium and beta-hemolytic streptococcus, and pathology showed benign inflammatory changes. Consequently, allergic fungal rhinosinusitis (AFRS) was the leading diagnosis. Symptoms persisted for several years despite multiple courses of oral and intranasal steroids, antihistamines, and leukotriene modifiers. She had no history of pneumonia or recurrent infections. An allergic and immunologic workup was initiated upon consultation in our clinic. Labs revealed normal immunoglobulins, protective tetanus/diphtheria titers but a diminished response to the pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route, lot# and expiration date were not reported) for prophylaxis (3 protective titers post-vaccination) (Therapeutic response decreased). Total Immunoglobulin E (IgE) was 1161 international unit per litre (IU/L). Specific IgE testing for molds was negative. The patient was diagnosed with specific antibody deficiency.   The outcome of the event was unknown. The reporter considered the event to be related to pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown).  A copy of the published article has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effects; The patient received Vaqta following a temperature excursion; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 28-OCT-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA), one dose for prophylaxis (route of administration, anatomical location, lot number and expiration date were not reported) (product storage error).  The administered dose of the vaccine experienced a temperature excursion below 36°F/2°C (35F) for 430 minutes. No adverse effects reported.
Sex: U
Vaccine: HEPA, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received VAQTA and GARDASIL 9 following a temperature excursion; no adverse effects; This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 28-OCT-2019, the patient was vaccinated with an improperly stored dose of hepatitis a vaccine, inactivated (VAQTA) for prophylaxis (dosage schedule route of administration, anatomical location, lot number and expiration date were not reported) and  hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) for prophylaxis (dosage schedule, route of administration, anatomical location, lot number and expiration date were not reported) (product storage error).  The administered doses of the vaccines experienced a temperature excursion below 36°F/2°C (35F) for 430 minutes. There was no previous temperature excursion. No adverse effects reported.
Sex: F
Vaccine: VARZOS
Symptoms: Deafness, Macular fibrosis, Retinoschisis, Visual acuity reduced, Vitreoretinal traction syndrome
Clinical narrative: Epiretinal Membrane; Vitreomacular Traction; hearing loss; Information has been received from a lawyer regarding a case in litigation concerning a lawyer refers to a female patient(pt) of unknown age.The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 25-AUG-2017, the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately August 2017 (reported as "Shortly after receiving zoster vaccine live(ZOSTAVAX)"), the pt suffered an abrupt visual acuity and separated retina as well as hearing loss. Pt was diagnosed with Epiretinal Membrane and Vitreomacular Traction. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experienced mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   Macular fibrosis, deafness and vitreoretinal traction syndrome were considered to be disability. Upon internal review, macular fibrosis, deafness and vitreoretinal traction syndrome were determined to be medically significant.
Sex: F
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects reported; female patient who is currently 15 years old received 4th dose of HPV series, GARDASIL 9 on 11/2/2019; Information has been received from a medical assistant via a field employee, referring to a 15 years old female patient. The patient's pertinent medical history and drug reactions/allergies were not reported. Concomitant medication included influenza virus vaccine (unspecified).  On 02-MAY-2016, 11-AUG-2016 and 18-JAN-2017, the patient was vaccinated with the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) dose 1, dose 2 and dose 3 (strength, dose detail, route, lot # and expiration date were unknown) for prophylaxis.  On 02-NOV-2019, the patient was vaccinated with 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot#: 1621934, expire date was 29-JAN-2022; strength, dose and route were unknown) (inappropriate schedule of product administration). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Groin pain, Herpes zoster, Lymphadenopathy
Clinical narrative: Lymph node swelling, severe left sided groin pain and abdominal pain, ultimatelydiagnosed with shingles; Information has been received from a lawyer regarding a case in litigation concerning a female patient(pt) of unknown age. The pt's medical history, concurrent conditions and concomitant medications were not provided. On or around 23-OCT-2013 , the pt was vaccinated with zoster vaccine live(ZOSTAVAX) (dose, route of administration, anatomical location, lot#, expiration date were unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). In approximately October 2013 (reported as "Shortly after receiving zoster vaccine live(ZOSTAVAX)"),  the pt suffered lymph node swelling, severe left sided groin pain and abdominal pain where pt was ultimately diagnosed with shingles. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt's symptoms had resulted in physical limitations not present prior to using zoster vaccine live(ZOSTAVAX). Pt also experiencesd mental and emotional distress due to resulting physical limitations and seriousness of her condition. As a result of the zoster vaccine live(ZOSTAVAX), pt sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live(ZOSTAVAX), pt suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment oflife, physical impairment and injury. As a direct and proximate result of zoster vaccine live(ZOSTAVAX), pt had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.   Shingles was considered to be disability.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported.; a patient received improperly stored PROQUAD on 11/1/2019; This spontaneous report was received from a nurse referring a patient of unknown age and gender. Information about pertinent medical history, drug reactions/allergies and concomitant therapies was not provided.    On 01-NOV-2019, the patient received improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (lot # S021617 and expiration date 09-FEB-2021; strength, dose, frequency and route were not reported) for prophylaxis (product storage error). The measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) was reconstituted with properly stored diluent. No adverse effect was reported. The vaccine underwent temperature between -14 degrees Celsius to -10 degrees Celsius (-11.7 Celsius) for a duration of 2 hours 35 minutes. There was no previous temperature excursion and the call was because of data logger.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; improperly stored vaccine administered; varivax was administered intramuscularly; This spontaneous report was received from a nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 06-NOV-2019, the patient was vaccinated with improperly stored varicella virus vaccine live (oka/merck) (VARIVAX), intramuscular route for prophylaxis (# lot S010297, expiry date 03-APR-2021, dose, strength, vaccination site unspecified). Concomitant medications included sterile diluent (lot# S002638, expiry date 31-OCT-2021). The vaccine varicella virus vaccine live (oka/merck) (VARIVAX) was reconstituted with properly stored sterile diluent at a temperature of 15 degrees Fahrenheit to 46 degrees Fahrenheit for a time frame of 16 hours. There was no previous temperature excursion. No digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved.