chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Swelling
Clinical narrative: Patient reported cellulitis and severe localized swelling
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper
Clinical narrative: Woke up around 2am with intense upper abdominal pain that wasn't subsiding, did not feel like any digestive type issue. Made it very difficult to try and get ready to go to ER so realized I probably couldn't drive myself, took Tylenol and after a while (45min-ish?) it subsided enough that I could go back to sleep.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site rash
Clinical narrative: Patient reported large bruise-like rash around injection site
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Back injury, Back pain, Fall, Feeling abnormal, Muscle spasms
Clinical narrative: Patient states she developed muscle weakness that night and her legs cramped up.  She says she fell out of her chair and went to the emergency room because she hurt her back when she fell.  I called to remind her of her second dose needed in October and that is how I found out.  She says she still feels weak and not like herself before the shot.  She says she still has back pain. Patient reports ER doctor did not feel the muscle weakness was related to the vaccine.  She did not know the name of the ER doctor.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness
Clinical narrative: Patient states she developed muscle weakness that night and her legs cramped up.  She says she fell out of her chair and went to the emergency room because she hurt her back when she fell.  I called to remind her of her second dose needed in October and that is how I found out.  She says she still feels weak and not like herself before the shot.  She says she still has back pain. Patient reports ER doctor did not feel the muscle weakness was related to the vaccine.  She did not know the name of the ER doctor.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Pt received the influenza vaccine at her pediatrician's office. That evening, she developed urticaria. urticaria was spreading, so she seeked care at urgent care on the third day of urticaria. There was no anaphylaxis. There were no other exposures to which the urticaria could be attributed. she was prescribed cetirizine at urgent care.
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: Red rash on arm below vaccination site on outside of arm on bicep and tricep. It did not itch
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: She developed a rash all over body the morning after her immunization. She cannot think of any other reason she would have a rash.
Age: 26.0
Sex: F
Vaccine: DTAP
Symptoms: Anxiety, Diarrhoea, Disorientation, Vomiting
Clinical narrative: Disorientation, vomiting, diarrhea, sense of impending doom. Lasted for several hours.
Age: 89.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: patient reported increasing swelling, soreness, redness, and heat at injection site. Pt sought treatment at local Urgent Care. Patient received rx for Sulfamethoxazole/Trimethoprim 400/80 BID x10 days
Age: 59.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Hives, using Allegra, Benadryl, baking soda baths, calamine lotion, Benadryl gel
Age: 75.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Headache, Hypersomnia, Pyrexia, Tremor
Clinical narrative: High fever, 100 degrees, and severe uncontrollable shakes, severe headache.  No vomiting or diarrhea.  Paramedics called but vitals were all good except high fever.  Took OTC Tylenol PM or Tylenol every 4 hours and lots of sleep.
Age: 52.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Tinnitus
Clinical narrative: The afternoon of the day after I received the second dose of Shingrix I developed severe Tinnitus (ringing in the ears) so loud it made it impossible to sleep that night. On day3 the nurse practitioner prescribed anti-viral medicine - Valcyclovir - to be take 3 X  daily and about halfway through the next day the symptoms started to subside but they are still not gone.
Age: 77.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Chills, Cough, Oropharyngeal pain, Pain, Pain in extremity
Clinical narrative: Night after injection: sore arm, October 24--body aches, chills, October 25-runny nose, cough, aches, chills; October 26 deep persistent cough, congestion, pain when cough, sore throat, coughing interrupting sleep; all symptoms continuing October 27, October 28
Age: 77.0
Sex: M
Vaccine: FLU4, PNC13
Symptoms: Respiratory tract congestion, Rhinorrhoea, Sleep disorder
Clinical narrative: Night after injection: sore arm, October 24--body aches, chills, October 25-runny nose, cough, aches, chills; October 26 deep persistent cough, congestion, pain when cough, sore throat, coughing interrupting sleep; all symptoms continuing October 27, October 28
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles, Injection site warmth
Clinical narrative: The patient developed a red raised blister on her left deltoid, patient reported this developed within 24 hours of vaccine. It did not itch & was warm to the touch. Patient later Followed up with MD. MD stated blister may be due to Fluid accumilation in subcutaneous tissue. On 10/25/19 patient stated blister is popped & flat. Patient will Follow up if anything else changes.
Age: 11.0
Sex: F
Vaccine: FLU4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Erythema + swelling to Bil deltoids
Age: 90.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Muscle spasms
Clinical narrative: Patient Reports transient muscle spasms in arm where Shingrix was administered. Reports that it only happens when his arm is at Rest and there may be a lump in arm there.
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Swelling & redness at local site, warm & erythematous indurated area Irregular of 1-3cm x 4cm with enlarging surrounding area of light erythema. Given Rx Acetaminophen for pain and recommended cold compresses for 4 days and if continues could apply warm compresses. If area of redness continues to increase was advised to fill Rx for Cephalexin antibiotics.
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Discomfort, Erythema, Musculoskeletal disorder, Myalgia
Clinical narrative: PPSV 23 has caused very swollen arm from shoulder to hand Still frightfully swollen 3 days after injection Low grade fever, muscle ache was first day & a half; unable to use arm to get out of bed night of the shot (Chills & discomfort began in evening day of shot) PCV13 rec'd 4.5 yrs ago without incident* Arm swollen & painful unable to get out of bed - red, hot, swelling The slight fever & chills went away after a day. But swollen, hot, red painful arm for 2 days. Pain disapated but swollen arm continues even with icing & antiinfamatory meds. 3 days later is still BADLY SWOLLEN
Age: 78.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia, Skin warm
Clinical narrative: PPSV 23 has caused very swollen arm from shoulder to hand Still frightfully swollen 3 days after injection Low grade fever, muscle ache was first day & a half; unable to use arm to get out of bed night of the shot (Chills & discomfort began in evening day of shot) PCV13 rec'd 4.5 yrs ago without incident* Arm swollen & painful unable to get out of bed - red, hot, swelling The slight fever & chills went away after a day. But swollen, hot, red painful arm for 2 days. Pain disapated but swollen arm continues even with icing & antiinfamatory meds. 3 days later is still BADLY SWOLLEN
Age: 16.0
Sex: M
Vaccine: HEP, HPV9, IPV, MMRV, MNQ, HEP, HPV9, IPV, MMRV, MNQ
Symptoms: Erythema, Swelling face
Clinical narrative: prescribing error; dispensing error; preparation for administration; right side of face red and swollen; right side of face red and swollen; patient is 16 and age cut off is 12 for proquad; This spontaneous report as received from a health professional via FDA refers to a 16-year-old White male patient. It was reported that the patient had no pertinent medical history, no known allergies and drug reactions and did not take any concomitant medications.  On 30-JAN-2019 at 16:00, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (lot # R019469, expiration date not reported, but upon internal validation established as 10-APR-2021, dose 2, intramuscular in the left arm), measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHa (PROQUAD) (lot number R022564, expiration date not reported, but upon internal validation established as 04-FEB-2020, dose 2, subcutaneous in the right arm), hepatitis b virus vaccine rhbsag (yeast) (ENGERIX-B) (lot number 27S5S, expiration date not reported, dose 3, intramuscular in the left arm), poliovirus vaccine inactivated (vero) (IPOL) (lot number P1A242M, expiration date not reported, dose 2, intramuscular in the right arm) and meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) (lot number U6151AB, expiration date not reported, dose 2, intramuscular in the left arm), for prophylaxis. On 01-FEB-2019 at 07:00, the patient woke up with right side of face red and swollen. No treatment was given. No laboratory tests were performed. The symptoms went away after 5 hours. The outcome of the events was reported as recovered.  The relatedness between the events and suspect therapies was not reported.   Follow up information has been received from an unspecified reporter (vaccine provider) on 23-OCT-2019.   The patient's details were updated. The patient was vaccinated with hepatitis b virus vaccine rhbsag (yeast) (ENGERIX-B) lot number 27S5S, expiration date: 20-OCT-2020, poliovirus vaccine inactivated (vero) (IPOL) lot number P1A242M, expiration date: 26-APR-2020, meningococcal acyw conj vaccine (dip toxoid) (MENACTRA) lot number U6151AB, expiration date: 16-MAR-2020.  It was reported that upon inspection of the vaccines, it was found that Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD) was supposed to be given to patient's under 12 years of age and however the patient was 16 years old (product administered to patient of inappropriate age). It was also reported that there was an error happened during prescribing, dispensing, preparation for administration and administration of vaccine. It was reported that the vaccine was not available for return as it was used and discarded.  The reporter considered swelling face to be related (reported as most likely) to HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast)(GARDASIL 9) and Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live(PROQUAD).   The reporter considered swelling face to be medically significant.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Blood test, Headache, Influenza virus test, Neck pain, Urine analysis
Clinical narrative: Had severe headaches and severe neck pains; Had severe headaches and severe neck pains; nausea; This is a spontaneous report from a contactable other healthcare professional on behalf of physician and consumer.  A 17-year-old female patient received first dose of meningococcal group b rlp2086 (TRUMENBA, lot number AA9699, expiration date 30Apr2020, strength 0.5ml), via intramuscular in left arm in Apr2019 at 0.5 ml, single for immunization. Medical history included rash on her hands and fingers in 2019. The patient experienced had severe headaches and severe neck pains on an unspecified date in 2019.  Clinical course: patient received 1st dose in Apr2019 and developed a systemic reaction: Severe headache and severe neck pain not alleviated by OTC (over the counter) analgesics; patient admitted to emergency room and received ketorolac tromethamine (TORADOL); and an antiemetic to treat what she believed was nausea although it was not listed in the note and was under observation but was discharged later that day. The reporter mentioned that the child was seen in their office 2 months prior for a rash on her hands and fingers, but that had resolved before she received the vaccine. The outcome of the events was unknown.; 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, as appropriate. The case will be reassessed if additional information becomes available.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Viral test
Clinical narrative: Had severe headaches and severe neck pains; Had severe headaches and severe neck pains; nausea; This is a spontaneous report from a contactable other healthcare professional on behalf of physician and consumer.  A 17-year-old female patient received first dose of meningococcal group b rlp2086 (TRUMENBA, lot number AA9699, expiration date 30Apr2020, strength 0.5ml), via intramuscular in left arm in Apr2019 at 0.5 ml, single for immunization. Medical history included rash on her hands and fingers in 2019. The patient experienced had severe headaches and severe neck pains on an unspecified date in 2019.  Clinical course: patient received 1st dose in Apr2019 and developed a systemic reaction: Severe headache and severe neck pain not alleviated by OTC (over the counter) analgesics; patient admitted to emergency room and received ketorolac tromethamine (TORADOL); and an antiemetic to treat what she believed was nausea although it was not listed in the note and was under observation but was discharged later that day. The reporter mentioned that the child was seen in their office 2 months prior for a rash on her hands and fingers, but that had resolved before she received the vaccine. The outcome of the events was unknown.; 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, as appropriate. The case will be reassessed if additional information becomes available.
Age: 17.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Headache, Nausea, Neck pain
Clinical narrative: Had severe headaches and severe neck pains; Had severe headaches and severe neck pains; nausea; This is a spontaneous report from a contactable other healthcare professional on behalf of physician and consumer.  A 17-year-old female patient received first dose of meningococcal group b rlp2086 (TRUMENBA, lot number AA9699, expiration date 30Apr2020, strength 0.5ml), via intramuscular in left arm in Apr2019 at 0.5 ml, single for immunization. Medical history included rash on her hands and fingers in 2019. The patient experienced had severe headaches and severe neck pains on an unspecified date in 2019.  Clinical course: patient received 1st dose in Apr2019 and developed a systemic reaction: Severe headache and severe neck pain not alleviated by OTC (over the counter) analgesics; patient admitted to emergency room and received ketorolac tromethamine (TORADOL); and an antiemetic to treat what she believed was nausea although it was not listed in the note and was under observation but was discharged later that day. The reporter mentioned that the child was seen in their office 2 months prior for a rash on her hands and fingers, but that had resolved before she received the vaccine. The outcome of the events was unknown.; 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, as appropriate. The case will be reassessed if additional information becomes available.
Age: 63.0
Sex: M
Vaccine: FLU4, VARZOS, FLU4, VARZOS
Symptoms: Bed rest, Blood test, Fatigue, Pyrexia, Urine analysis
Clinical narrative: Patient was given both shots at the same day.. Patient states that he had flu like symptoms for 3 weeks now, went to his primary doctor and had a fever of 101.5 degree F, did blood test twice there is elevated white blood cells, exhaustion and weight loss.
Age: 63.0
Sex: M
Vaccine: FLU4, VARZOS, FLU4, VARZOS
Symptoms: Blood test, Fatigue, Influenza like illness, Pyrexia, Weight decreased
Clinical narrative: Patient was given both shots at the same day.. Patient states that he had flu like symptoms for 3 weeks now, went to his primary doctor and had a fever of 101.5 degree F, did blood test twice there is elevated white blood cells, exhaustion and weight loss.
Age: 63.0
Sex: M
Vaccine: FLU4, VARZOS, FLU4, VARZOS
Symptoms: White blood cell count increased
Clinical narrative: Patient was given both shots at the same day.. Patient states that he had flu like symptoms for 3 weeks now, went to his primary doctor and had a fever of 101.5 degree F, did blood test twice there is elevated white blood cells, exhaustion and weight loss.
Age: 75.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3
Symptoms: Deafness
Clinical narrative: Profound hearing loss in both ears. ER visit, prednisone, referred to ENT.  ENT injected steroid into left ear, sent me for MRI.  Started Hyperbaric Oxygen Therapy on 10/28/19. No change yet but I will need 20 HBO  sessions and 2 more steroid injections.
Age: 75.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3
Symptoms: Audiogram abnormal, Blood test, Chest X-ray, Deafness bilateral, Magnetic resonance imaging
Clinical narrative: Profound hearing loss in both ears. ER visit, prednisone, referred to ENT.  ENT injected steroid into left ear, sent me for MRI.  Started Hyperbaric Oxygen Therapy on 10/28/19. No change yet but I will need 20 HBO  sessions and 2 more steroid injections.
Age: 75.0
Sex: F
Vaccine: FLUA3, PPV, FLUA3
Symptoms: Urine analysis
Clinical narrative: Profound hearing loss in both ears. ER visit, prednisone, referred to ENT.  ENT injected steroid into left ear, sent me for MRI.  Started Hyperbaric Oxygen Therapy on 10/28/19. No change yet but I will need 20 HBO  sessions and 2 more steroid injections.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Pain in extremity
Clinical narrative: Patient came in to the pharmacy a few weeks later stating that she still has a sore arm. She refuses to take anything over the counter to help with discomfort. Reports having a sore arm while hiking the mountains with a heavy backpack.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Local reaction, Pain in extremity, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Child had pain and swelling in left arm the evening after the flu vaccine was admin. Temp. max 100.8, arm pain and swelling continued and parents took child to local ER on 10/25/19 diagnosed with local reaction to flu vaccine.  Seen in our office 10/26/19 given 5 days of prednisone tablet 20 mg 3 tables once a day for 5 days for arm still warm to touch and itching.  Told to stop prednisone sooner if symptoms were relieved before 5 days.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: Child had pain and swelling in left arm the evening after the flu vaccine was admin. Temp. max 100.8, arm pain and swelling continued and parents took child to local ER on 10/25/19 diagnosed with local reaction to flu vaccine.  Seen in our office 10/26/19 given 5 days of prednisone tablet 20 mg 3 tables once a day for 5 days for arm still warm to touch and itching.  Told to stop prednisone sooner if symptoms were relieved before 5 days.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Started on valtrex for  outbreak of shingles in cervical 6-7 dermatome left arm  ? Unsure if this is related to vaccine or not, but I felt as her physician it needed reported. She got shot at Pharmacy and I only treated the shingles. I have no follow up at this time.
Age: 1.92
Sex: M
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; the patient was vaccinated with the first dose of an improperly stored VARIVAX and M M R II; This spontaneous report was received from a medical assistant, regarding a 23 month old male patient. The patient's illness at the time of vaccination were reported as none. Pre-existing physician diagnosed allergies, birth defects and medical conditions were not reported. Concomitant medications included hepatitis A virus vaccine (unspecified).  On 30-SEP-2019 (reported as 30-SEP-2018), the patient was vaccinated with an improperly stored Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) (dose and location of administration were not reported) (lot # R028382, expiration date 10-MAR-2020) and with an improperly stored varicella virus vaccine live (Oka/Merck) (VARIVAX) (dose and location of administration were not reported) (lot # R033660, expiration date 20-NOV-2020). Both vaccines were administered intramuscularly (IM) for prophylaxis. The patient was vaccinated at a private doctor's office hospital and the vaccine was purchased with public funds.  The Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) was exposed to a temperature of 13.13 degree Celsius since 23-MAY-2019 to 02-OCT-2019. There were no previous temperature excursions, however, on an unknown date the vaccine had a temperature excursion with a highest temperature above 9 degree Celsius (58.96 degree Celsius) for 8299 and 45 minutes. The varicella virus vaccine live (Oka/Merck) (VARIVAX) was exposed to a temperature of 13.28 degree Celsius from 30-MAY-2019 to 02-OCT-2019. There were no previous temperature excursions, however on an unknown date, the vaccine was exposed to a temperature from 9 to 25 degree Celsius (25.4 degree Celsius) for a time frame of 8290 hours and 30 minutes. The call was because a digital data logger. No adverse effects were reported  This is one of several reports from the same reporter.  ; Sender's Comments:  US-009507513-1910USA007637: US-009507513-1910USA012351: US-009507513-1910USA012352: US-009507513-1910USA012357: US-009507513-1910USA012354: US-009507513-1910USA012355: US-009507513-1910USA012359: US-009507513-1910USA012349: US-009507513-1910USA012240: US-009507513-1910USA012360: US-009507513-1910USA012981: US-009507513-1910USA012358: US-009507513-1910USA012353: US-009507513-1910USA012356:
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: experienced hives after receiving the first dose of GARDASIL 9; Information was received from a physician  via a field representative, referring to a 13 years old female patient. The patient's medical history, concurrent condition and concomitant medications were not provided.  On an unknown date, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose, strength, route, lot#, expiration date were unknown) for prophylaxis.  On an unknown date, the patient experienced hives. The patient was given diphenhydramine hydrochloride (BENADRYL) for hives. The outcome of the event was recovered. The causality was not reported by the reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Aphasia, Dysarthria, Hypoaesthesia, Mental status changes, Paraesthesia
Clinical narrative: Patient suffered a sudden onset numbness of his right cheek and right hand, along with difficulty finding words. The patient was diagnosed with a transient ischemic attack and paresthesia.; Patient suffered a sudden onset numbness of his right cheek and right hand, along with difficulty finding words. The patient was diagnosed with a transient ischemic attack and paresthesia.; The patient later suffered another onset of altered mental status, slurred speech and facial numbness and was diagnosed with another transient ischemic attack; This initial spontaneous report was received on 21-OCT-2019, from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 04-JAN-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (the dosage regiment information was not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a sudden onset numbness of his right cheek and right hand, along with difficulty finding words. The patient was admitted to the hospital and diagnosed with a transient ischemic attack and paresthesia. Later, on an unspecified date, he suffered another onset of altered mental status, slurred and facial numbness and was diagnosed with another transient ischemic attack. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient's symptoms had resulted in physical limitations not present prior to vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations, seriousness of his condition, 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. The causality assessment was related.  Upon internal review, transient ischemic attack was considered to be medically significant. Paresthesia and transient ischemic attack were disabling.
Sex: M
Vaccine: VARZOS
Symptoms: Transient ischaemic attack
Clinical narrative: Patient suffered a sudden onset numbness of his right cheek and right hand, along with difficulty finding words. The patient was diagnosed with a transient ischemic attack and paresthesia.; Patient suffered a sudden onset numbness of his right cheek and right hand, along with difficulty finding words. The patient was diagnosed with a transient ischemic attack and paresthesia.; The patient later suffered another onset of altered mental status, slurred speech and facial numbness and was diagnosed with another transient ischemic attack; This initial spontaneous report was received on 21-OCT-2019, from a lawyer regarding a case in litigation and refers to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On 04-JAN-2016, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (the dosage regiment information was not reported) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered a sudden onset numbness of his right cheek and right hand, along with difficulty finding words. The patient was admitted to the hospital and diagnosed with a transient ischemic attack and paresthesia. Later, on an unspecified date, he suffered another onset of altered mental status, slurred and facial numbness and was diagnosed with another transient ischemic attack. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccination, the patient's symptoms had resulted in physical limitations not present prior to vaccination. The patient also experienced mental and emotional distress due to resulting physical limitations, seriousness of his condition, 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. The causality assessment was related.  Upon internal review, transient ischemic attack was considered to be medically significant. Paresthesia and transient ischemic attack were disabling.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse symptoms reported; vaccinated with PNEUMOVAX 23 on 10/29/2018 and 10/08/2019; This spontaneous report was received from a pharmacist referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were unknown. On 29-OCT-2018 and 08-OCT-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dosing details, lot number, expiration date, anatomical location were unknown) via unknown route for prophylaxis (inappropriate schedule of product administration). It was reported as on 24-OCT-2019, the event inappropriate schedule of product administration was identified. No adverse symptoms were reported. The outcome of the events was unknown. No product quality complaint (PQC) involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect reported; improperly stored V ARlV AX; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's concomitant medications, pertinent medical history and current conditions was not provided.   On 23-OCT-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) (lot # S015459, expiration date 20-MAY-2021; frequency and dose number were unknown) subcutaneously for prophylaxis (product storage error). The temperature range was 14 degrees Celsius below zero to 10 degrees Celsius below zero for 2 hours 11 minutes. There was no previous temperature excursion for the product. Enclosed was temperature logger. The sterile diluent used for reconstitution did not experience an excursion. No adverse effect were reported. No product quality complaint (PQC) was involved.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Rash, Vaccination failure
Clinical narrative: Suspected vaccination failure; Shingles; My upper arm was covered in a rash; Felt like someone had struck me with a baseball bat; This case was reported by a consumer and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date).   On an unknown date, the patient received the 1st dose of Shingrix. In April 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and less than 9 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, rash and feeling abnormal. On an unknown date, the outcome of the vaccination failure, shingles, rash and feeling abnormal were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, rash and feeling abnormal to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had both doses of Shingrix the second dose administered in April 2019. The patient upper arm was covered in a rash the next day and felt like someone had struck me with a baseball bat. The patient stated that most aggravating part was that she had two outbreaks of shingles since then. The patient just one of the unfortunate 10 percent and there was nothing else to be done. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation for herpes zoster was unknown. This case was considered to be a suspected vaccination failure case, as the details regarding laboratory confirmation and time to onset for herpes zoster was unknown.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Feeling abnormal, Headache, Myalgia
Clinical narrative: Severe headache; Chills; Fever of 100; Myalgia; Slight Upset Stomach; feeling horrible; This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (at the age of 26 years).   On 16th October 2019 14:30, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, 13 hrs 30 min after receiving Shingrix, the patient experienced fever, myalgia, upset stomach and feels awful. On 16th October 2019 20:00, the patient experienced headache and chills. On an unknown date, the outcome of the headache, chills, fever, myalgia, upset stomach and feels awful were not recovered/not resolved.   It was unknown if the reporter considered the headache, chills, fever, myalgia, upset stomach and feels awful to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm On the same day, at around 8 PM at night, 5 hours 30 minutes after receiving Shingrix, the patient developed a slight headache and slight chills. The patient stated, she went to the bed but woke up at approximately 4 AM on 17th October 2019 feeling horrible with violent or severe headache, chills, fever of 100 degree F, myalgia and slight upset stomach. The patient consented to follow up and also provided her physician's details. There was discrepancy in the outcome of the event, in the source document it was reported as recovering/ resolving and in the system it was reported as not recovered/ not resolved.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe headache; Chills; Fever of 100; Myalgia; Slight Upset Stomach; feeling horrible; This case was reported by a consumer via call center representative and described the occurrence of headache in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (at the age of 26 years).   On 16th October 2019 14:30, the patient received the 1st dose of Shingrix (intramuscular). In October 2019, 13 hrs 30 min after receiving Shingrix, the patient experienced fever, myalgia, upset stomach and feels awful. On 16th October 2019 20:00, the patient experienced headache and chills. On an unknown date, the outcome of the headache, chills, fever, myalgia, upset stomach and feels awful were not recovered/not resolved.   It was unknown if the reporter considered the headache, chills, fever, myalgia, upset stomach and feels awful to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in her left arm On the same day, at around 8 PM at night, 5 hours 30 minutes after receiving Shingrix, the patient developed a slight headache and slight chills. The patient stated, she went to the bed but woke up at approximately 4 AM on 17th October 2019 feeling horrible with violent or severe headache, chills, fever of 100 degree F, myalgia and slight upset stomach. The patient consented to follow up and also provided her physician's details. There was discrepancy in the outcome of the event, in the source document it was reported as recovering/ resolving and in the system it was reported as not recovered/ not resolved.
Sex: U
Vaccine: FLU4
Symptoms: Adverse reaction
Clinical narrative: Unknown Adverse Event; This case was reported by a nurse via call center representative and described the occurrence of adverse reaction in a adult patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2015-2016 season) (batch number DX4SN, expiry date unknown) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2015-2016 season. On an unknown date, less than 4 months after receiving Fluarix Quadrivalent 2015-2016 season, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Fluarix Quadrivalent 2015-2016 season.  Additional details were provided as follows: The reporter did not provide age, age at vaccination, gender or any patient details. The age group was selected as adult as the patient was an employee. The patient developed an unknown adverse event in 2015 after receiving Fluarix. The reporter did not provide any further information.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Lethargy
Clinical narrative: Pain at injection site; Reddness at injection site; Swelling; Itching at injection site.; Lethargy; This case was reported by a physician via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In August 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced injection site pain, injection site erythema, injection site swelling, injection site itching and lethargy. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling, injection site itching and lethargy were unknown.   It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, injection site itching and lethargy to be related to Shingrix.  Additional details were provided as follows: The reporter did not have lot or expiration date. The patient received the dose of Shingrix 2 months ago and experienced pain, redness, swelling and had itching at injection site, following day was lethargic. The reporter consented to follow up.
Age: 70.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Asthenia, Fatigue, Feeling abnormal, Injection site pain
Clinical narrative: weak; fatigue; feels out of it; injection site soreness; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Concurrent medical conditions included shoulder pain.   On 16th October 2019, the patient received the 2nd dose of Shingrix and Influenza vaccine Quadrivalent 2019-2020 season. On 16th October 2019, less than a day after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced injection site pain. On 17th October 2019, the patient experienced weakness, fatigue and feeling abnormal. On an unknown date, the outcome of the injection site pain, weakness, fatigue and feeling abnormal were unknown.   It was unknown if the reporter considered the injection site pain, weakness, fatigue and feeling abnormal to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: On 14th October 2019, the patient received Steriod injection in her left shoulder due to pain. The patient received Shingrix in her right arm and  flu vaccine in the left arm. The reporter did not knew the name of the flu vaccine she received. The patient experienced soreness at the injection sites but on the day of reporting, the patient was weak and felt out of it. The patient asked about the use of shingrix with the steriod injection, but was told by the pharmacist so long as she was not taking it, she would be fine. The patient also asked about receiving the flu vaccine at the same time, if that could also be causing the weak feeling.  The patient was referred to discuss these issues with her physician but also shared the side effect of fatigue from the clinical trials and use with GSK flu vaccine of Fluarix.
Sex: F
Vaccine: TTOX, VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: shingles; Post herpetic neuralgia; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included TETANUS TOXOID (TETANUS VACCINE) for prophylaxis.   Concurrent medical conditions included post herpetic neuralgia and sinus infection.   On 12th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and TETANUS VACCINE. On 19th September 2019, 99 days after receiving Shingrix, the patient experienced shingles and post herpetic neuralgia. The patient was treated with acyclovir and steroids nos (Steroids). On an unknown date, the outcome of the shingles and post herpetic neuralgia were unknown.   It was unknown if the reporter considered the shingles and post herpetic neuralgia to be related to Shingrix.  Additional details were provided as follows: The reporter stated that she received her dose 1st of Shingrix vaccine with a tetanus vaccine and while being treated for a sinus infection. She stated that she was treated for the sinus infection with antibiotics and then developed a yeast infection. on 19th September 2019, she developed shingles and was treated with acyclovir and steroids. She stated that she still has post herpatic neuralgia. The reporter did not consent to follow-up. The reporter did not have vaccine information for this adverse event (AE).
Sex: F
Vaccine: VARZOS
Symptoms: Abnormal dreams, Arthralgia, Dizziness, Fatigue, Impaired work ability
Clinical narrative: Soreness at the injection site; Tired; Weird dreams; tossed and turned during the night; Fever; Injection site only feels tender / Arm still tender; Severe body aches; Joint pain; Severely nauseous; Dizzy / Lightheaded; Felt ill; Unable to go to work; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ulcerative colitis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 6 hrs after receiving Shingrix, the patient experienced injection site pain, tiredness, bizarre dreams, sleep disorder, fever, pain in arm, general body pain, joint pain, nausea, dizziness, malaise and inability to work. On an unknown date, the outcome of the injection site pain, fever and nausea were recovered/resolved and the outcome of the tiredness, pain in arm and dizziness were not recovered/not resolved and the outcome of the bizarre dreams, sleep disorder, general body pain, joint pain, malaise and inability to work were unknown.   It was unknown if the reporter considered the injection site pain, tiredness, bizarre dreams, sleep disorder, fever, pain in arm, general body pain, joint pain, nausea, dizziness, malaise and inability to work to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. Less than year after vaccination, the patient experienced tiredness, bizarre dreams, sleep disorder, fever, pain in arm, general body pain, joint pain, nausea, dizziness, malaise and inability. Unable to obtain additional information. The reporter consented to follow up. For tolerance to 2nd dose refer linked case US2019AMR190454, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Nausea, Pain, Pain in extremity
Clinical narrative: Soreness at the injection site; Tired; Weird dreams; tossed and turned during the night; Fever; Injection site only feels tender / Arm still tender; Severe body aches; Joint pain; Severely nauseous; Dizzy / Lightheaded; Felt ill; Unable to go to work; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ulcerative colitis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 6 hrs after receiving Shingrix, the patient experienced injection site pain, tiredness, bizarre dreams, sleep disorder, fever, pain in arm, general body pain, joint pain, nausea, dizziness, malaise and inability to work. On an unknown date, the outcome of the injection site pain, fever and nausea were recovered/resolved and the outcome of the tiredness, pain in arm and dizziness were not recovered/not resolved and the outcome of the bizarre dreams, sleep disorder, general body pain, joint pain, malaise and inability to work were unknown.   It was unknown if the reporter considered the injection site pain, tiredness, bizarre dreams, sleep disorder, fever, pain in arm, general body pain, joint pain, nausea, dizziness, malaise and inability to work to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. Less than year after vaccination, the patient experienced tiredness, bizarre dreams, sleep disorder, fever, pain in arm, general body pain, joint pain, nausea, dizziness, malaise and inability. Unable to obtain additional information. The reporter consented to follow up. For tolerance to 2nd dose refer linked case US2019AMR190454, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Sleep disorder
Clinical narrative: Soreness at the injection site; Tired; Weird dreams; tossed and turned during the night; Fever; Injection site only feels tender / Arm still tender; Severe body aches; Joint pain; Severely nauseous; Dizzy / Lightheaded; Felt ill; Unable to go to work; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included ulcerative colitis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 6 hrs after receiving Shingrix, the patient experienced injection site pain, tiredness, bizarre dreams, sleep disorder, fever, pain in arm, general body pain, joint pain, nausea, dizziness, malaise and inability to work. On an unknown date, the outcome of the injection site pain, fever and nausea were recovered/resolved and the outcome of the tiredness, pain in arm and dizziness were not recovered/not resolved and the outcome of the bizarre dreams, sleep disorder, general body pain, joint pain, malaise and inability to work were unknown.   It was unknown if the reporter considered the injection site pain, tiredness, bizarre dreams, sleep disorder, fever, pain in arm, general body pain, joint pain, nausea, dizziness, malaise and inability to work to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. Less than year after vaccination, the patient experienced tiredness, bizarre dreams, sleep disorder, fever, pain in arm, general body pain, joint pain, nausea, dizziness, malaise and inability. Unable to obtain additional information. The reporter consented to follow up. For tolerance to 2nd dose refer linked case US2019AMR190454, reported by the same reporter.