chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Injection site erythema, Injection site vesicles, Nasopharyngitis
Clinical narrative: respiratory tract infection; Blister like shingles; Cold; Injection site blister; redness; swelling; Blister on a left ankle, both feet and hands/ Injection site blister; This case was reported by a consumer via call center representative and described the occurrence of upper respiratory tract infection in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included antibiotics nos (Antibiotics (Brand Names Not Known)).   In June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, swelling arm, blister and injection site blisters. On an unknown date, the patient experienced upper respiratory tract infection (serious criteria GSK medically significant), shingles and cold. On an unknown date, the outcome of the upper respiratory tract infection, shingles, blister and injection site blisters were not recovered/not resolved and the outcome of the injection site erythema and swelling arm were recovered/resolved and the outcome of the cold was unknown.   It was unknown if the reporter considered the upper respiratory tract infection, shingles, injection site erythema, swelling arm, blister, cold and injection site blisters to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix vaccine 4 weeks ago from the date of reporting.  The patient reported that redness presented at the injection site the day of the administration which was resolved. A week later a blister formed at the injection site on her left arm that grew in size and resulted in her arm swelling. Another blister formed on her left ankle the same day. With the past 3 weeks, from the date of reporting, the blisters have spread to both feet and hands.  The patient also reported having an upper respiratory infection in the past two weeks from a cold. She described the blisters as looking like shingles. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Peripheral swelling, Upper respiratory tract infection
Clinical narrative: respiratory tract infection; Blister like shingles; Cold; Injection site blister; redness; swelling; Blister on a left ankle, both feet and hands/ Injection site blister; This case was reported by a consumer via call center representative and described the occurrence of upper respiratory tract infection in a 68-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included antibiotics nos (Antibiotics (Brand Names Not Known)).   In June 2019, the patient received the 1st dose of Shingrix. In June 2019, less than a day after receiving Shingrix, the patient experienced injection site erythema, swelling arm, blister and injection site blisters. On an unknown date, the patient experienced upper respiratory tract infection (serious criteria GSK medically significant), shingles and cold. On an unknown date, the outcome of the upper respiratory tract infection, shingles, blister and injection site blisters were not recovered/not resolved and the outcome of the injection site erythema and swelling arm were recovered/resolved and the outcome of the cold was unknown.   It was unknown if the reporter considered the upper respiratory tract infection, shingles, injection site erythema, swelling arm, blister, cold and injection site blisters to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient received Shingrix vaccine 4 weeks ago from the date of reporting.  The patient reported that redness presented at the injection site the day of the administration which was resolved. A week later a blister formed at the injection site on her left arm that grew in size and resulted in her arm swelling. Another blister formed on her left ankle the same day. With the past 3 weeks, from the date of reporting, the blisters have spread to both feet and hands.  The patient also reported having an upper respiratory infection in the past two weeks from a cold. She described the blisters as looking like shingles. The reporter consented to follow-up.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: rash; itching; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 72-year-old male patient who received Herpes zoster (Shingrix) (batch number GX25K, expiry date 19th November 2021) for prophylaxis.   On 1st July 2019, the patient received the 1st dose of Shingrix (intramuscular). On 2nd July 2019, 1 days after receiving Shingrix, the patient experienced rash and pruritus. The patient was treated with methylprednisolone. On an unknown date, the outcome of the rash was unknown and the outcome of the pruritus was recovering/resolving.   It was unknown if the reporter considered the rash and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The registered pharmacist stated that the patient developed rash and itching the next day after receiving Shingrix or the day after that.  He started on methylprednisolone and before the date of reporting he was doing much better. He was experiencing only a little itching. The status of the rash was unknown. The reporter consented to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis, Loss of consciousness, Nausea, Pain in extremity
Clinical narrative: Syncope; passed out in the bathroom; Dizziness / Light headed /feeling dizzy; Nausea; Sweating; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of syncope in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LG54, expiry date 25th September 2021) for prophylaxis.   On 7th July 2019 16:30, the patient received the 1st dose of Shingrix (intramuscular). On 8th July 2019, 1 days after receiving Shingrix, the patient experienced syncope (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), dizziness, nausea and sweating. In July 2019, the patient experienced pain in arm. The patient was treated with ibuprofen (Advil). On 8th July 2019, the outcome of the passed out was recovered/resolved. On an unknown date, the outcome of the syncope, pain in arm, dizziness, nausea and sweating were recovering/resolving.   It was unknown if the reporter considered the syncope, passed out, pain in arm, dizziness, nausea and sweating to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on the left arm. Next morning of vaccination, the patient woke up at 7 AM in the morning with a sore arm. The patient started feeling dizzy, light headed, nauseated and sweating.  The patient was passed out in the bathroom for few seconds. At the time of reporting, the patient was feeling better. No further details were provided. The reporter did not consent to follow up.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Syncope
Clinical narrative: Syncope; passed out in the bathroom; Dizziness / Light headed /feeling dizzy; Nausea; Sweating; Sore arm; This case was reported by a consumer via call center representative and described the occurrence of syncope in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number 9LG54, expiry date 25th September 2021) for prophylaxis.   On 7th July 2019 16:30, the patient received the 1st dose of Shingrix (intramuscular). On 8th July 2019, 1 days after receiving Shingrix, the patient experienced syncope (serious criteria GSK medically significant), passed out (serious criteria GSK medically significant), dizziness, nausea and sweating. In July 2019, the patient experienced pain in arm. The patient was treated with ibuprofen (Advil). On 8th July 2019, the outcome of the passed out was recovered/resolved. On an unknown date, the outcome of the syncope, pain in arm, dizziness, nausea and sweating were recovering/resolving.   It was unknown if the reporter considered the syncope, passed out, pain in arm, dizziness, nausea and sweating to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix on the left arm. Next morning of vaccination, the patient woke up at 7 AM in the morning with a sore arm. The patient started feeling dizzy, light headed, nauseated and sweating.  The patient was passed out in the bathroom for few seconds. At the time of reporting, the patient was feeling better. No further details were provided. The reporter did not consent to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Skin reaction, Urticaria
Clinical narrative: Welts on arm and leg; Blisters; severe skin reaction; This case was reported by a nurse via call center representative and described the occurrence of welts in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2018, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced welts, blister and skin reaction. Shingrix was discontinued. On an unknown date, the outcome of the welts, blister and skin reaction were unknown.   It was unknown if the reporter considered the welts, blister and skin reaction to be related to Shingrix.  Additional details were provided as follows: The nurse practitioner reported that the patient had a bad reaction after receiving Shingrix. The patient discontinuing Shingrix and would not receive booster due to a severe skin reaction of blisters & welts bilaterally on arms and legs.  No additional details were provided. The nurse practitioner did not have all the information at the time of reporting.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue
Clinical narrative: feeling tired; This case was reported by a consumer via call center representative and described the occurrence of tiredness in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a week after receiving Shingrix, the patient experienced tiredness. On an unknown date, the outcome of the tiredness was unknown.   It was unknown if the reporter considered the tiredness to be related to Shingrix.  Additional information received were as follows: The patient reported that she was feeling tired. The caller declined to provide any further details or information, including demographics. The reporter did not consent to follow up.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site induration, Local reaction
Clinical narrative: Localized event. Induration at site with large red area around it
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient developed bright red rash on torso after receiving 4 month immunizations. The rash persisted for about 5 minutes prior to starting to resolve. Patient was in office for about 10 minutes and although rash was still present, it appeared to going away, No facial involvement or difficulty breathing
Age: 33.0
Sex: M
Vaccine: HEP, TDAP, VARCEL
Symptoms: Back pain, Laboratory test normal, Pain in extremity
Clinical narrative: Patient dropping off another prescription told RPH he had pain in back radiating to legs and went to ER. ER ran labs and found none abnormal and provided any diagnosis. Primary physician reported by pharmacist and MD determined to not provide boosters for vaccine. Patient states is currently fine at time of report
Age: 12.0
Sex: F
Vaccine: HEPA, MNQ
Symptoms: Syncope
Clinical narrative: After receiving vaccines, patient had syncopal episode. Pt recovered and was in stable condition and went home with family.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Immediate post-injection reaction, Injection site pain, Nausea
Clinical narrative: Sore arm at injection site immediately after injection lasting about 24 hours. Chills starting 12 hours after injection, combined with overall body aches, mild headache, mild nausea.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Sore arm at injection site immediately after injection lasting about 24 hours. Chills starting 12 hours after injection, combined with overall body aches, mild headache, mild nausea.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Diarrhoea, Gastrointestinal pain
Clinical narrative: Intestinal cramping and diarrhea.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness, Nausea, Syncope, Vomiting
Clinical narrative: About 3 minutes after receiving the vaccination the patient had a brief syncopal episode after he stood up to walk out of the room. The MA assisting patient believes he lost consciousness, she had to hold on to him and lay him down on the table. The patient stated he nearly passed out. He felt dizzy and nauseated. He had one emesis. His vitals remained normal. He recovered completely about 7-10 minutes after laying flat.
Age: 32.0
Sex: F
Vaccine: HEP
Symptoms: No adverse event
Clinical narrative: There has been no reported adverse events
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pyrexia
Clinical narrative: patient developed flu like symptoms and had a high grade fever
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 75-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 26-SEP-2013, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for shingles resulting from her use of zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of shingles was unknown. The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain, Pyrexia
Clinical narrative: Fever; Body ache; joint pain; This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (experienced by patient when she was 25 years old). Concomitant products included Herpes zoster (Shingrix).   On 24th June 2019, the patient received the 2nd dose of Shingrix. In June 2019, less than a day after receiving Shingrix and an unknown time after receiving Shingrix, the patient experienced general body pain and joint pain. On 25th June 2019, the patient experienced fever. The patient was treated with paracetamol (Tylenol). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fever, general body pain and joint pain were unknown.   It was unknown if the reporter considered the fever, general body pain and joint pain to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix and experienced body aches and joint pain. At the date of reporting, in the morning, the patient woke up with a 100 degree F fever. This case has been linked with US2019115066, reported for the dose 1 of the same patient.
Sex: F
Vaccine: VARZOS
Symptoms: Vision blurred
Clinical narrative: blurred vision; This case was reported by a pharmacist via call center representative and described the occurrence of blurred vision in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced blurred vision. On an unknown date, the outcome of the blurred vision was resolved with sequelae.   It was unknown if the reporter considered the blurred vision to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, the patient received the first dose of the Shingrix in an unknown deltoid, a couple of months ago from the time of reporting and experienced blurred vision for 12 hours post vaccination. Additional information was not provided.
Sex: F
Vaccine: MENB
Symptoms: Chills, Feeling cold, Tremor
Clinical narrative: Shaking, Shivering and Very Cold; Shaking, Shivering and Very Cold; Shaking, Shivering and Very Cold; This is a spontaneous report from a contactable physician. An 18-year-old female patient received first dose of meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in Jun2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The physician wanted to know if it's okay to give second dose if patient reporting shivering after first dose. The patient received her first dose about a month ago (Jun2019). She was fine while in the office. When she got home, the mother called reporting that patient was shaking, shivering, and very cold. This lasted about 30-40 minutes and then she was fine. The patient recovered from the events on an unspecified date in Jun2019.   Information on the batch number has been requested.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness, pain and tenderness at the injection site; redness, pain and tenderness at the injection site; This is a spontaneous report from a contactable nurse via a Pfizer Sales Representative. This nurse reported similar events for three patients (nurse's mother and two patients in the office). This is the first of three reports.  A female patient (mother of nurse) of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced redness, pain and tenderness at the injection site. Outcome of the events was unknown.   Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019296476 different patient, same drug and event;US-PFIZER INC-2019296477 different patient, same drug and event
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: redness, pain and tenderness at the injection site; redness, pain and tenderness at the injection site; flare; This is a spontaneous report from a contactable nurse via a Pfizer Sales Representative. This nurse reported similar events for three patients (nurse's mother and two patients in the office). This is the third of three reports.  A male patient of an unspecified age received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13, unknown lot number and expiration date), via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient experienced redness, pain and tenderness at the injection site. The patient also experienced flare on unspecified date. Outcome of the events was unknown.   Information on the batch number has been requested.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019296476 different patient, same drug and event;US-PFIZER INC-2019296429 different patient, same drug and event;US-PFIZER INC-2019296429 different patient, same drug and event
Age: 18.0
Sex: U
Vaccine: MENB
Symptoms: Chills, Feeling cold, Headache, Hyperhidrosis, Influenza virus test negative
Clinical narrative: Vaccine administered at approximately 9am on 7/1/2019.  Patient's arm hurt & she developed a headache.  She went to her job as a caregiver at 8pm.  By 10pm, she was having chills and could not get warm.  She awoke again and was sweating, had body pain.  At 5:08am she called me (mother) and said she was in excrutiating pain, had a fever and felt that her heart was racing.  She stated she could not leave her elderly client until next caregiver came in at 8am.  At 8am, I (mother) called doctor's office about patient's symptoms.  They told me to bring her in right away.  We arrived between 8:30-9am.  Patient had a fever over 100 and her heart was racing. They did flu and strep swab and both were negative.  We were there
Age: 18.0
Sex: U
Vaccine: MENB
Symptoms: Laboratory test, Pain, Pain in extremity, Palpitations, Pyrexia
Clinical narrative: Vaccine administered at approximately 9am on 7/1/2019.  Patient's arm hurt & she developed a headache.  She went to her job as a caregiver at 8pm.  By 10pm, she was having chills and could not get warm.  She awoke again and was sweating, had body pain.  At 5:08am she called me (mother) and said she was in excrutiating pain, had a fever and felt that her heart was racing.  She stated she could not leave her elderly client until next caregiver came in at 8am.  At 8am, I (mother) called doctor's office about patient's symptoms.  They told me to bring her in right away.  We arrived between 8:30-9am.  Patient had a fever over 100 and her heart was racing. They did flu and strep swab and both were negative.  We were there
Age: 18.0
Sex: U
Vaccine: MENB
Symptoms: Streptococcus test negative
Clinical narrative: Vaccine administered at approximately 9am on 7/1/2019.  Patient's arm hurt & she developed a headache.  She went to her job as a caregiver at 8pm.  By 10pm, she was having chills and could not get warm.  She awoke again and was sweating, had body pain.  At 5:08am she called me (mother) and said she was in excrutiating pain, had a fever and felt that her heart was racing.  She stated she could not leave her elderly client until next caregiver came in at 8am.  At 8am, I (mother) called doctor's office about patient's symptoms.  They told me to bring her in right away.  We arrived between 8:30-9am.  Patient had a fever over 100 and her heart was racing. They did flu and strep swab and both were negative.  We were there
Age: 87.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Inflammation, Rash erythematous, Rash pruritic
Clinical narrative: Red inflamed, itchy rash. Prescribed triamcinolone cream.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Intermittent pain and swelling in left upper arm since received vaccines.  Has a 1/2 cm palpable nodule at the injection site
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pain, Peripheral swelling, Pruritus
Clinical narrative: Left arm swelling x 7 days. Redness and pain reducing at 5 days. Sever itching.  No fever, respiratory distress, swallowing difficulties, dizziness or additional MSK symptoms
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Dysphemia
Clinical narrative: Onset of severe stuttering, not previously seen in patient
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Deafness, Disturbance in attention, Macular degeneration, Reading disorder, Tinnitus
Clinical narrative: Patient has macular degeneration in the right eye.  A normal functioning left eye.  Ringing in the ears (but constant due to loss of hearing)  After getting the shot within 4 days after receiving the patient has had a decrease in vision in the left eye.  He has trouble reading and trouble focusing.  He said he also has constant ringing in the ears, but cant determine if that is from hearing loss, or the vaccine.  Vision was blurry, and to see/read the patient needed to look to the left of it to see it.  He couldn't see it by looking directly at it.  He said colors were more vibrant and when closed he could see "thousands" of little specs floating around.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: Patient has macular degeneration in the right eye.  A normal functioning left eye.  Ringing in the ears (but constant due to loss of hearing)  After getting the shot within 4 days after receiving the patient has had a decrease in vision in the left eye.  He has trouble reading and trouble focusing.  He said he also has constant ringing in the ears, but cant determine if that is from hearing loss, or the vaccine.  Vision was blurry, and to see/read the patient needed to look to the left of it to see it.  He couldn't see it by looking directly at it.  He said colors were more vibrant and when closed he could see "thousands" of little specs floating around.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Localized rash on left upper arm near injection site.
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Autopsy, Blood culture negative, Brain death, Brain herniation, CSF culture negative
Clinical narrative: The patient was visiting, where she received the Men B vaccine about 2 weeks before presenting to our hospital gravely ill. Within days of receiving the vaccine she developed malaise. A few days before presenting to our hospital she developed subjective fevers and worsening malaise. On the day of presentation she had persistent vomiting, then had a seizure (no history of seizures) that was treated with anti-epileptics at an outside hospital. She was transferred to our institution and, en route, developed agonal breathing and abnormal posturing, with uncal herniation found on head CT soon after arrival. She received ceftriaxone and acyclovir and underwent external ventricular drain placement, but was declared brain dead <24 hours after arrival at our hospital. Autopsy is underway, but no causative agent has been identified yet.  - Note: As the MenB vaccine was given somewhere else, we do not know the exact date / details of the vaccine (date listed in this form is estimated, as the family stated it was given 2 weeks before she presented to our hospital on 7/4/19)
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: CSF test normal, Computerised tomogram head abnormal, HIV test negative, Herpes simplex test negative, Laboratory test
Clinical narrative: The patient was visiting, where she received the Men B vaccine about 2 weeks before presenting to our hospital gravely ill. Within days of receiving the vaccine she developed malaise. A few days before presenting to our hospital she developed subjective fevers and worsening malaise. On the day of presentation she had persistent vomiting, then had a seizure (no history of seizures) that was treated with anti-epileptics at an outside hospital. She was transferred to our institution and, en route, developed agonal breathing and abnormal posturing, with uncal herniation found on head CT soon after arrival. She received ceftriaxone and acyclovir and underwent external ventricular drain placement, but was declared brain dead <24 hours after arrival at our hospital. Autopsy is underway, but no causative agent has been identified yet.  - Note: As the MenB vaccine was given somewhere else, we do not know the exact date / details of the vaccine (date listed in this form is estimated, as the family stated it was given 2 weeks before she presented to our hospital on 7/4/19)
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Malaise, Polymerase chain reaction, Posturing, Pyrexia, Respiration abnormal
Clinical narrative: The patient was visiting, where she received the Men B vaccine about 2 weeks before presenting to our hospital gravely ill. Within days of receiving the vaccine she developed malaise. A few days before presenting to our hospital she developed subjective fevers and worsening malaise. On the day of presentation she had persistent vomiting, then had a seizure (no history of seizures) that was treated with anti-epileptics at an outside hospital. She was transferred to our institution and, en route, developed agonal breathing and abnormal posturing, with uncal herniation found on head CT soon after arrival. She received ceftriaxone and acyclovir and underwent external ventricular drain placement, but was declared brain dead <24 hours after arrival at our hospital. Autopsy is underway, but no causative agent has been identified yet.  - Note: As the MenB vaccine was given somewhere else, we do not know the exact date / details of the vaccine (date listed in this form is estimated, as the family stated it was given 2 weeks before she presented to our hospital on 7/4/19)
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Respiratory viral panel, Seizure, Ventricular drainage, Vomiting
Clinical narrative: The patient was visiting, where she received the Men B vaccine about 2 weeks before presenting to our hospital gravely ill. Within days of receiving the vaccine she developed malaise. A few days before presenting to our hospital she developed subjective fevers and worsening malaise. On the day of presentation she had persistent vomiting, then had a seizure (no history of seizures) that was treated with anti-epileptics at an outside hospital. She was transferred to our institution and, en route, developed agonal breathing and abnormal posturing, with uncal herniation found on head CT soon after arrival. She received ceftriaxone and acyclovir and underwent external ventricular drain placement, but was declared brain dead <24 hours after arrival at our hospital. Autopsy is underway, but no causative agent has been identified yet.  - Note: As the MenB vaccine was given somewhere else, we do not know the exact date / details of the vaccine (date listed in this form is estimated, as the family stated it was given 2 weeks before she presented to our hospital on 7/4/19)
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Brain death, CSF shunt operation, Depressed level of consciousness, Endotracheal intubation, Headache
Clinical narrative: The patient was visiting, where she received the Men B vaccine about 2 weeks before presenting to our hospital gravely ill. Within days of receiving the vaccine she developed malaise. A few days before presenting to our hospital she developed subjective fevers and worsening malaise. On the day of presentation she had persistent vomiting, then had a seizure (no history of seizures) that was treated with anti-epileptics at an outside hospital. She was transferred to our institution and, en route, developed agonal breathing and abnormal posturing, with uncal herniation found on head CT soon after arrival. She received ceftriaxone and acyclovir and underwent external ventricular drain placement, but was declared brain dead <24 hours after arrival at our hospital. Autopsy is underway, but no causative agent has been identified yet.  - Note: As the MenB vaccine was given somewhere else, we do not know the exact date / details of the vaccine (date listed in this form is estimated, as the family stated it was given 2 weeks before she presented to our hospital on 7/4/19)
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Intensive care, Intracranial pressure increased, Lethargy, Seizure, Status epilepticus
Clinical narrative: The patient was visiting, where she received the Men B vaccine about 2 weeks before presenting to our hospital gravely ill. Within days of receiving the vaccine she developed malaise. A few days before presenting to our hospital she developed subjective fevers and worsening malaise. On the day of presentation she had persistent vomiting, then had a seizure (no history of seizures) that was treated with anti-epileptics at an outside hospital. She was transferred to our institution and, en route, developed agonal breathing and abnormal posturing, with uncal herniation found on head CT soon after arrival. She received ceftriaxone and acyclovir and underwent external ventricular drain placement, but was declared brain dead <24 hours after arrival at our hospital. Autopsy is underway, but no causative agent has been identified yet.  - Note: As the MenB vaccine was given somewhere else, we do not know the exact date / details of the vaccine (date listed in this form is estimated, as the family stated it was given 2 weeks before she presented to our hospital on 7/4/19)
Age: 18.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Viral infection, Vomiting
Clinical narrative: The patient was visiting, where she received the Men B vaccine about 2 weeks before presenting to our hospital gravely ill. Within days of receiving the vaccine she developed malaise. A few days before presenting to our hospital she developed subjective fevers and worsening malaise. On the day of presentation she had persistent vomiting, then had a seizure (no history of seizures) that was treated with anti-epileptics at an outside hospital. She was transferred to our institution and, en route, developed agonal breathing and abnormal posturing, with uncal herniation found on head CT soon after arrival. She received ceftriaxone and acyclovir and underwent external ventricular drain placement, but was declared brain dead <24 hours after arrival at our hospital. Autopsy is underway, but no causative agent has been identified yet.  - Note: As the MenB vaccine was given somewhere else, we do not know the exact date / details of the vaccine (date listed in this form is estimated, as the family stated it was given 2 weeks before she presented to our hospital on 7/4/19)
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Pt had adverse reaction of dizziness and lightheadedness. Vitals where obtained. Pt was monitored in clinic 15 mins post reaction. Pt. states feeling better. Pt reassessed prior to leaving clinic and vitals rechecked.  Pt instructed to follow up with PCP if symptoms worsen. Pt and parent verbalized understanding. Pt accompanied home with parent.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Pyrexia
Clinical narrative: Diarrhea; chills; fever
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Decreased appetite, Induration, Peripheral swelling, Pyrexia, Rash
Clinical narrative: 07/15/2019  Mother states Patient's R. leg is 'swollen, rock hard and with rash". Mother states she is going to take baby to the ER. She reports that Patient had fever on Saturday, but it responded to Tylenol, and he has not had fever since. Baby is taking less formula than usual. 07/06/2019 Case manger called Mother to F/U on yesterday's ER visit and Patient's condition. L/M on V/M requesting return call. Case manger called to ER. Confirmed that Patient was seen in ER yesterday and was treated and released.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Dermatitis diaper, Pyrexia
Clinical narrative: Client went to the ER with a fever on 7/12/2019. Ears and throat WNL. Client did have a diaper rash.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Herpes Zoster; Post-Herpetic Neuralgia; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 73-year-old female patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On or about 17-JUN-2013, the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for Herpes Zoster and Post-Herpetic Neuralgia resulting from her use of zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of  Herpes Zoster and Post-Herpetic Neuralgia was unknown. The reporter considered  Herpes Zoster and Post-Herpetic Neuralgia to be related to Zoster Vaccine Live(ZOSTAVAX).
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes Zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation referring to a currently 82-year-old male patient. The patient's pertinent medical history, concurrent conditions or concomitant medications were not reported. On an unspecified date in April 2008 the patient was vaccinated with zoster vaccine live(ZOSTAVAX) (lot#, expiration date, dosage and route of administration were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, the patient was treated for Herpes Zoster resulting from his use of zoster vaccine live(ZOSTAVAX). At the time of the report, the outcome of Herpes Zoster was unknown. The reporter considered Herpes Zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Nausea, Pain
Clinical narrative: nausea; body aches; weakness; headache; chills; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 71-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. In April 2019, less than a day after receiving Shingrix, the patient experienced nausea, general body pain, weakness, headache and chills. On an unknown date, the outcome of the nausea, general body pain, weakness, headache and chills were recovered/resolved.   It was unknown if the reporter considered the nausea, general body pain, weakness, headache and chills to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's friend. The patient received the vaccine at the same location and time where his friend received the vaccine. Within few hours of vaccination, the patient developed body aches, nausea, weakness, chills and headache. All these symptoms had resolved within 4.5 to 5 days. The reporter did not consent to follow-up. The reporter did  not consent to health care professional (HCP) follow up. This case had been linked to US2019123828, reported by the same reporter for her friend.
Age: 20.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site mass, Injection site rash, Injection site warmth
Clinical narrative: Patient states next morning she had a small lump under the shot on her R. arm. On the 3rd day after getting the shot the lump increased dramatically in size and was red and warm to the touch. With several red spots at injection site. 1 week later small blist still present.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Lip swelling, Pruritus, Urticaria
Clinical narrative: pt reported itching, hives, lip swelling
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Erythema, Headache, Influenza like illness, Injection site swelling
Clinical narrative: 1st day itching , headache and swelling at site of injection . By night I was itching all over and my face was swelling . I took 3 Benadryl. Woke up with swollen shut eyes and pain like flu but took alieve and ice pack and went to church . By 2 night I was fevered, shaky and muscle aches and more swelling . Arm was more red and swollen . Couldn?t sleep but a few minutes off and on . Day 3 arm still hot and swollen and aches and pains like flu . Stayed in bed all day . Day 4 still swollen and fevered arm but went to pharmacy to see if this was normal . She said to call you and make a report  because she had not seen or heard of one like mine . Plus I have had diarrhea for 2 days now .
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Myalgia, Nervousness, Peripheral swelling, Pruritus generalised
Clinical narrative: 1st day itching , headache and swelling at site of injection . By night I was itching all over and my face was swelling . I took 3 Benadryl. Woke up with swollen shut eyes and pain like flu but took alieve and ice pack and went to church . By 2 night I was fevered, shaky and muscle aches and more swelling . Arm was more red and swollen . Couldn?t sleep but a few minutes off and on . Day 3 arm still hot and swollen and aches and pains like flu . Stayed in bed all day . Day 4 still swollen and fevered arm but went to pharmacy to see if this was normal . She said to call you and make a report  because she had not seen or heard of one like mine . Plus I have had diarrhea for 2 days now .
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Skin warm, Swelling face, Swelling of eyelid
Clinical narrative: 1st day itching , headache and swelling at site of injection . By night I was itching all over and my face was swelling . I took 3 Benadryl. Woke up with swollen shut eyes and pain like flu but took alieve and ice pack and went to church . By 2 night I was fevered, shaky and muscle aches and more swelling . Arm was more red and swollen . Couldn?t sleep but a few minutes off and on . Day 3 arm still hot and swollen and aches and pains like flu . Stayed in bed all day . Day 4 still swollen and fevered arm but went to pharmacy to see if this was normal . She said to call you and make a report  because she had not seen or heard of one like mine . Plus I have had diarrhea for 2 days now .
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Dyspnoea, Electrocardiogram, Feeling hot, Full blood count
Clinical narrative: Immediately, during time frame 30-90 mins after inoculation: Shortness of Breath / Labored Breathing, Lighthead-ness, Body felt like it was overheating from the inside out, Narrowed Vision, Tremor/exaggerated twitching.  I went into urgent care at vaccine-administering hospital between 60-90 mins after inoculation, doctor notes were: PR ECG AND INTERPRETATION,   PR IV INFUS HYDRATION INIT 31 MIN TO 1 HR , PR METHYLPRED SOD SUCC (BU PER 125MG) *SOLUMEDROL INJ , PR NORMAL SALINE SOLN 1000ML INF, PR TX/ PROPHY/ DX INJ IV PUSH SNGL/ INIT DRUG , PR ZYRTEC SYRUP 1MG EA .   Continuing Reaction: essential tremors since immediate onset post inoculation.  I'm currently taking Propranolol 60mg, 3 times a day, and Primidone 50mg, 2 twice a day.  The medication is still trial and error to suppress the tremors.  To date, the tremors are not fully suppressed.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Imaging procedure, Immediate post-injection reaction, Metabolic function test, Muscle twitching, Nuclear magnetic resonance imaging spinal
Clinical narrative: Immediately, during time frame 30-90 mins after inoculation: Shortness of Breath / Labored Breathing, Lighthead-ness, Body felt like it was overheating from the inside out, Narrowed Vision, Tremor/exaggerated twitching.  I went into urgent care at vaccine-administering hospital between 60-90 mins after inoculation, doctor notes were: PR ECG AND INTERPRETATION,   PR IV INFUS HYDRATION INIT 31 MIN TO 1 HR , PR METHYLPRED SOD SUCC (BU PER 125MG) *SOLUMEDROL INJ , PR NORMAL SALINE SOLN 1000ML INF, PR TX/ PROPHY/ DX INJ IV PUSH SNGL/ INIT DRUG , PR ZYRTEC SYRUP 1MG EA .   Continuing Reaction: essential tremors since immediate onset post inoculation.  I'm currently taking Propranolol 60mg, 3 times a day, and Primidone 50mg, 2 twice a day.  The medication is still trial and error to suppress the tremors.  To date, the tremors are not fully suppressed.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Scan with contrast, Thyroid function test, Thyroxine free, Tremor, Tri-iodothyronine free
Clinical narrative: Immediately, during time frame 30-90 mins after inoculation: Shortness of Breath / Labored Breathing, Lighthead-ness, Body felt like it was overheating from the inside out, Narrowed Vision, Tremor/exaggerated twitching.  I went into urgent care at vaccine-administering hospital between 60-90 mins after inoculation, doctor notes were: PR ECG AND INTERPRETATION,   PR IV INFUS HYDRATION INIT 31 MIN TO 1 HR , PR METHYLPRED SOD SUCC (BU PER 125MG) *SOLUMEDROL INJ , PR NORMAL SALINE SOLN 1000ML INF, PR TX/ PROPHY/ DX INJ IV PUSH SNGL/ INIT DRUG , PR ZYRTEC SYRUP 1MG EA .   Continuing Reaction: essential tremors since immediate onset post inoculation.  I'm currently taking Propranolol 60mg, 3 times a day, and Primidone 50mg, 2 twice a day.  The medication is still trial and error to suppress the tremors.  To date, the tremors are not fully suppressed.
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Visual impairment
Clinical narrative: Immediately, during time frame 30-90 mins after inoculation: Shortness of Breath / Labored Breathing, Lighthead-ness, Body felt like it was overheating from the inside out, Narrowed Vision, Tremor/exaggerated twitching.  I went into urgent care at vaccine-administering hospital between 60-90 mins after inoculation, doctor notes were: PR ECG AND INTERPRETATION,   PR IV INFUS HYDRATION INIT 31 MIN TO 1 HR , PR METHYLPRED SOD SUCC (BU PER 125MG) *SOLUMEDROL INJ , PR NORMAL SALINE SOLN 1000ML INF, PR TX/ PROPHY/ DX INJ IV PUSH SNGL/ INIT DRUG , PR ZYRTEC SYRUP 1MG EA .   Continuing Reaction: essential tremors since immediate onset post inoculation.  I'm currently taking Propranolol 60mg, 3 times a day, and Primidone 50mg, 2 twice a day.  The medication is still trial and error to suppress the tremors.  To date, the tremors are not fully suppressed.
Age: 85.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Injection site warmth
Clinical narrative: Swelling at injection site, warm to touch, used cold compress and went down, swollen pouch at bottom elbow two days after injection.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Erythema, Fatigue
Clinical narrative: Pain, swelling, and redness at site. Pain and redness migrated down arm over 5-6 days.  Headaches  Body aches Fever and chills Joint aches and pain Lack of appetite  Lethargy and fatigue
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Lethargy
Clinical narrative: Pain, swelling, and redness at site. Pain and redness migrated down arm over 5-6 days.  Headaches  Body aches Fever and chills Joint aches and pain Lack of appetite  Lethargy and fatigue
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: Pain, swelling, and redness at site. Pain and redness migrated down arm over 5-6 days.  Headaches  Body aches Fever and chills Joint aches and pain Lack of appetite  Lethargy and fatigue
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Dizziness
Clinical narrative: Patient experienced lightheaded/dizziness/feeling faint immediately after receiving the vaccination.  Patient was allowed to lay down and feet elevated.  Symptoms resolved after approx 8 minutes.  She was monitored for an addition 15-20 minutes and released without issue.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Blood bilirubin increased, Dyspnoea, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: Patient experienced lightheaded/dizziness/feeling faint immediately after receiving the vaccination.  Patient was allowed to lay down and feet elevated.  Symptoms resolved after approx 8 minutes.  She was monitored for an addition 15-20 minutes and released without issue.
Age: 22.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Jaundice, Nausea, Vomiting
Clinical narrative: Patient experienced lightheaded/dizziness/feeling faint immediately after receiving the vaccination.  Patient was allowed to lay down and feet elevated.  Symptoms resolved after approx 8 minutes.  She was monitored for an addition 15-20 minutes and released without issue.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient is complaining of arm pain continuing long after she has received her vaccination. She stated its a throbbing pain that comes and goes but is worse at night.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Pyrexia, Rash morbilliform
Clinical narrative: Measles like Rash and fever
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Headache, Nausea
Clinical narrative: Severe headache, nausea. Went to ER.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Headache, Myalgia
Clinical narrative: extreme shivers (teeth chattering), headache lasting more than 24 hours, muscle aches, low fever, tiredness, backache.  Had to leave work and sleep 14 hours.  After sleeping headache remained, but muscle aches were improved.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: extreme shivers (teeth chattering), headache lasting more than 24 hours, muscle aches, low fever, tiredness, backache.  Had to leave work and sleep 14 hours.  After sleeping headache remained, but muscle aches were improved.