chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HPV9
Symptoms: Pain in extremity
Clinical narrative: experienced pain in the arm after receiving the GARDASIL 9 vaccine; This spontaneous report was received from a pharmacist, via a company representative and refers to a 18 year old patient of unknown gender. No information was provided regarding the patient's historical conditions, previous drug reactions, allergies, concurrent conditions or concomitant medications.      On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) for prophylaxis (dose, route of administration, lot number and expiration date were not reported).         On an unknown date, the patient experienced pain in the arm after receiving the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) vaccine (pain in extremity). It was unknown if the patient received any treatment for the event.       The outcome of pain in extremity was reported as resolved at the reporting time and lasted for 1 week.      The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) and the event was unknown.      This is one of the 2 reports received form the same source.; Sender's Comments:  US-009507513-1905USA008739:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Malaise, Oral herpes, Pain
Clinical narrative: cold sores; not feeling right; achiness; chills; fever; "Flu-like symptoms"; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2019, the patient received the 1st dose of Shingrix (intramuscular) 0.5 ml. On 19th April 2019, 1 days after receiving Shingrix, the patient experienced feeling unwell, pain, chills, fever and influenza-like symptoms. On an unknown date, the patient experienced cold sores. On an unknown date, the outcome of the feeling unwell, pain, chills, fever, influenza-like symptoms and cold sores were recovered/resolved.   It was unknown if the reporter considered the feeling unwell, pain, chills, fever, influenza-like symptoms and cold sores to be related to Shingrix.  Additional case details were provided as follows: The patient received Shingrix in her left deltoid.   The next day, the patient was not feeling right and experienced achiness, chills, shivering, fever of 102.4 and flu-like symptoms. On an unknown date, less than a month, the patient also experienced cold sores.   The patient sought treatment at the local emergency room for fever.   The patient fully recovered from her symptoms.   The patient gave permission for safety to follow up with her physician.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: cold sores; not feeling right; achiness; chills; fever; "Flu-like symptoms"; This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th April 2019, the patient received the 1st dose of Shingrix (intramuscular) 0.5 ml. On 19th April 2019, 1 days after receiving Shingrix, the patient experienced feeling unwell, pain, chills, fever and influenza-like symptoms. On an unknown date, the patient experienced cold sores. On an unknown date, the outcome of the feeling unwell, pain, chills, fever, influenza-like symptoms and cold sores were recovered/resolved.   It was unknown if the reporter considered the feeling unwell, pain, chills, fever, influenza-like symptoms and cold sores to be related to Shingrix.  Additional case details were provided as follows: The patient received Shingrix in her left deltoid.   The next day, the patient was not feeling right and experienced achiness, chills, shivering, fever of 102.4 and flu-like symptoms. On an unknown date, less than a month, the patient also experienced cold sores.   The patient sought treatment at the local emergency room for fever.   The patient fully recovered from her symptoms.   The patient gave permission for safety to follow up with her physician.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema
Clinical narrative: Injection site redness; Fatigue; This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th March 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site erythema and fatigue. On an unknown date, the outcome of the injection site erythema and fatigue were recovered/resolved.   It was unknown if the reporter considered the injection site erythema and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient had redness at the injection site and a prolonged episode of fatigue for 3 weeks after receiving his first dose of Shingrix. No additional details provided. Call notes stated that the patient did not give details at the time of the call.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Computerised tomogram abnormal, Fatigue, Liver disorder, Pain, Pyrexia
Clinical narrative: liver disease; pain; swelling; fever; tiredness; This case was reported by a consumer via call center representative and described the occurrence of hepatic disease in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included nephrolithiasis (of kidney stones, so she saw her urologist).   On 22nd February 2019, the patient received the 1st dose of Shingrix (intramuscular). In February 2019, less than a month after receiving Shingrix, the patient experienced fever and tiredness. On 4th March 2019, the patient experienced hepatic disease, pain and swelling. On an unknown date, the outcome of the hepatic disease, pain and swelling were not recovered/not resolved and the outcome of the fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the hepatic disease, pain, swelling, fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The caller reported that the patient received Shingrix and afterwards she had common side effects like fever and tiredness that lasted about 1 week and she started having pain and swelling on her left side. The patient has a history of kidney stones, so she saw her urologist, but an ultrasound did not show any kidney stones. She had a CT scan it showed what could be liver disease. She was referred to a gastroenterologist and was going to have a nuclear scan next week.  Emergency room visit was required.  The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Ultrasound kidney normal
Clinical narrative: liver disease; pain; swelling; fever; tiredness; This case was reported by a consumer via call center representative and described the occurrence of hepatic disease in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included nephrolithiasis (of kidney stones, so she saw her urologist).   On 22nd February 2019, the patient received the 1st dose of Shingrix (intramuscular). In February 2019, less than a month after receiving Shingrix, the patient experienced fever and tiredness. On 4th March 2019, the patient experienced hepatic disease, pain and swelling. On an unknown date, the outcome of the hepatic disease, pain and swelling were not recovered/not resolved and the outcome of the fever and tiredness were recovered/resolved.   It was unknown if the reporter considered the hepatic disease, pain, swelling, fever and tiredness to be related to Shingrix.  Additional details were provided as follows: The caller reported that the patient received Shingrix and afterwards she had common side effects like fever and tiredness that lasted about 1 week and she started having pain and swelling on her left side. The patient has a history of kidney stones, so she saw her urologist, but an ultrasound did not show any kidney stones. She had a CT scan it showed what could be liver disease. She was referred to a gastroenterologist and was going to have a nuclear scan next week.  Emergency room visit was required.  The reporter consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash on arms; This case was reported by a consumer via call center representative and described the occurrence of rash in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st April 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced rash. The patient was treated with prednisolone. On an unknown date, the outcome of the rash was recovering/resolving.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The patient experienced rash on her arms.  The patient saw her physician and was treated with a prednisone taper and that the rash was improving but has not resolved yet. Consented to follow up.
Age: 59.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches; fever; This case was reported by a pharmacist via call center representative and described the occurrence of general body pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (Boostrix) for prophylaxis.   Concurrent medical conditions included methicillin-resistant staphylococcus aureus infection (carrier for MERSA).   On 13th May 2019, the patient received Shingrix and Boostrix. On 13th May 2019, several hours after receiving Shingrix and Boostrix, the patient experienced general body pain and fever. On an unknown date, the outcome of the general body pain and fever were unknown.   It was unknown if the reporter considered the general body pain and fever to be related to Shingrix and Boostrix.  Additional details were provided as follows: On 13th May 2019, both the Shingrix and Boostrix were administered at the same time and few hours later the patient experienced a fever and body aches. The clinical pharmacist was unaware if symptoms subsided.  The patient was carrier for Methicillin-resistant Staphylococcus aureus infection. The health care professional would like to know if medical information had information to share with the patient. The health care professional did not provide lot number and expiration dates.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Rash, Vomiting
Clinical narrative: PT. VOMITING AFTER BEING GIVEN THE ROTATEG (ORAL) VACCINE 3X. PT THEN BROKE OUT IN A RASH ON ENEST & ABDOMINAL AREA
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Day later feel very tired, shivers, chills. Low grade fever 100.4
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site warmth, Insomnia, Pain
Clinical narrative: Patient developed pain in the evening of 5/19.  It became very bad after about 12 hours from vaccination, she reports that pain was from left elbow to left deltoid.  It was hard for her to sleep that night.  Following that, pain has subsided somewhat until when she reported to me, evening of 5/22.  It is now only the actual injection site where she has pain, and pain is less than before (and continues to improve daily).  She said she did not have any redness or swelling at any point, but she did have some warmth in the area.  She did not have this same reaction with the first dose of Shingrix.  I counseled her to continue monitoring and let us know if it DID NOT continue to improve, and to see her PCP if symptoms got any worse.  She did not experience any constitional symptoms such as fever, chills, headache.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: PT. REC'D #2 HPV 11-9-07 L DELTOID IM. NO SWELLING REDNESS, OR OTHER REACTION NOTED. THEN ON 11-28-07 STARTED HAVING L DELTOID SWELLING & PAIN. WAS SEEN IN CLINIC 11-29-07, NOTED TO HAVE 1 1/2 - 2 CM HARDENED AREA L DELTOID TENDER TO TOUCH
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Pain in extremity, Peripheral swelling
Clinical narrative: Patient started with arm swelling in the left arm the night he received the vaccine. Reported as "blotchy" and the next day appeared to have fluid under them and resembled blisters.  On the night of 5/22, patient complained that his legs hurt, upon looking at them they were red, swollen, and blistered.  Patient went to his doctor on the morning of 5/23 in which he was diagnosed with shingles. Patient filled a prescription for a seven day course of valacylovir this morning.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash macular
Clinical narrative: Patient started with arm swelling in the left arm the night he received the vaccine. Reported as "blotchy" and the next day appeared to have fluid under them and resembled blisters.  On the night of 5/22, patient complained that his legs hurt, upon looking at them they were red, swollen, and blistered.  Patient went to his doctor on the morning of 5/23 in which he was diagnosed with shingles. Patient filled a prescription for a seven day course of valacylovir this morning.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Muscular weakness, Nausea, Pyrexia
Clinical narrative: Severe headache, muscle weakness, nausea, joint pain, fever
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Periarthritis, Product administered at inappropriate site
Clinical narrative: PT DEVELOPED LEFT FROZEN SHOULDER THE DAY AFTER HE RECEIVED SHINGRINX VACCINATION #1 IN LEFT DELTOID.  HE REPORTS THAT HE IS "SURE THAT VACCINE WAS RECEIVED IN THE DELTOID."  HE REPORTS PREVIOUS HISTORY OF LEFT FROZEN SHOULDER IN 2013 OR 2014 FOLLOWING A FLU SHOT THAT WAS "MOST LIKELY INJECTED INTO AN INTERSTITIAL SPACE NEAR THE LEFT SHOULDER JOINT."
Age: 42.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported back to us that she had swelling and redness at the injection site. She had some slight pain as well.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site warmth
Clinical narrative: Patient presents to the clinic for a nurse visit per this RN's request for a reported reaction to a immunization Pneumococcal 23 given in clinic 5/21/19 during a MWV. Patient states that her physical therapist had noticed the redness under her arm and had advised her to contact our clinic. On examination of Patient's right arm it is noted that she has a small red spot from the injection toward the bottom of her deltoid. No erythema of swelling at injection site. There was two faint lateral red streaks extending to the underside of her arm pit. The redness in her arm pit was approximately 2 inches by 1 inch, tender to touch, slight warmth. Because the area is tender touch, red and has evidence of creeping discoloration I did ask a provider to examine. NP examined Patient, NP encouraged Patient to try warm compresses to her underarm, monitor for increased swelling, pain or redness. Advised if her symptoms worsen or do not resolve she should go to a Urgent Care to be seen. Patient agreed with the plan. This RN drew a circle around the erythema in her underarm for measure and monitoring. A Vaccine information sheet was provided with information about mild to sever injection site reactions. Informed I will put in the VAERS. This RN also verified that the vaccine provided had not expired and had been stored at the appropriate temperature.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Conjunctivitis, Cough, Morbillivirus test positive, Polymerase chain reaction positive, Pyrexia
Clinical narrative: Patient reported to Clinic on 5/15/19 w/ 5 day history of conjunctivitis, cough, runny nose and fever. Rash onset the morning of  report- 5/15/19. Patient assessed in walk-in clinic, but specimens not collected. Testing facilitated through Emergency Department the evening of 5/15/19.
Age: 1.25
Sex: F
Vaccine: DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash, Rhinorrhoea
Clinical narrative: Patient reported to Clinic on 5/15/19 w/ 5 day history of conjunctivitis, cough, runny nose and fever. Rash onset the morning of  report- 5/15/19. Patient assessed in walk-in clinic, but specimens not collected. Testing facilitated through Emergency Department the evening of 5/15/19.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Pt in office to have labs drawn following yesterdays office visit.  Pt stated while in the lab that she had an injection yesterday and that her left arm was now red, swollen, warm and sore.  NP was called into look at the patients arm.  Per NP patient was given Benadryl LOT: 162435 EXP: 06/2019 NDC: 0904-5306-61.  Red raised warm area was circled and measured.  Measurements are 7 3/4 inches vertically and 4 1/4 inches horizontally.  Immunization information Pneumococcal Vaccine Pneumovax 23 lot: R011632 EXP: 02/20/2020 NDC: 0006-4837-01 administered in Left Deltoid.  Reaction reported at www.vaers.hhs.gov.  Patient instructed to take benadryl every 6 hours as needed and use warm/cold compresses.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Injection site discomfort, Injection site erythema, Injection site mass, Injection site warmth
Clinical narrative: Moments after receiving the HIB vaccine, the patient had a quarter-sized red lump at the injection sight in his left thigh. The redness lasted for two weeks. As of 5/23/19 the redness has completely subsided, but there is still a dime-sized hard lump at the injection sight.  The lump was hot to the touch for the first week, and cased the patient (my child) discomfort for one week.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: arm swollen & painful. LA right below the site where meningitis vaccine was given.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 57 year old female patient. No information was provided regarding concomitant medications, concurrent conditions or medical history. Approximately on 22-AUG-2017, when the pt was 55 years old, she was vaccinated by a pharmacist with zoster vaccine live (ZOSTAVAX) for long term prevention of shingles and zoster-related conditions. On an unknown date, the pt experienced herpes zoster resulting from zoster vaccine live (ZOSTAVAX) use and she received treatment from a healthcare provider at the facility. The outcome of herpes zoster was unknown. The reporter considered herpes zoster to be related to Zoster Vaccine Live(ZOSTAVAX).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Bruising at injection site / site of the injection turned black and blue then purplish; redness at injection site / large area turned red, then purplish; injection site swelling; injection site warmth / felt hot to the touch; This case was reported by a consumer via call center representative and described the occurrence of injection site bruising in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax.   On 14th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On 16th March 2019, 2 days after receiving Shingrix, the patient experienced injection site bruising, injection site erythema, injection site swelling and injection site warmth. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)). On 21st March 2019, the outcome of the injection site bruising, injection site erythema, injection site swelling and injection site warmth were recovered/resolved.   It was unknown if the reporter considered the injection site bruising, injection site erythema, injection site swelling and injection site warmth to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine on left deltoid. Two days after first dose of Shingrix, the patient noticed the site of the injection turned black and blue and below the site, a large area turned red, then purplish. It was swollen and felt hot to the touch. After five days, patient went to her doctor who said it was not a systemic reaction but a topical one. The patient received an antibiotic and four to five days later, it resolved. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Ophthalmic herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of ophthalmic herpes zoster in a female patient who received SHINGRIX for prophylaxis. Co-suspect products included SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX and the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and not applicable after receiving SHINGRIX, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant) and incomplete course of vaccination. On an unknown date, the outcome of the ophthalmic herpes zoster and incomplete course of vaccination were unknown. It was unknown if the reporter considered the ophthalmic herpes zoster to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced shingles in eye. The patient had not received 2nd dose within recommended 2 to 6 months later, which led to incomplete course of vaccination. The reporter did not have further detailed information.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Allergy to vaccine, Diverticulitis, Fatigue, Hypersensitivity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diverticulitis in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included diverticulitis. On 9th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th March 2019, 7 hrs after receiving SHINGRIX, the patient experienced tiredness. On 10th March 2019, the patient experienced diverticulitis (serious criteria GSK medically significant), fever, allergic reaction, stomach pain and spleen pain. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the diverticulitis, tiredness, allergic reaction, stomach pain and spleen pain were recovering/resolving and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the diverticulitis and spleen pain to be related to SHINGRIX. The reporter considered the tiredness, fever, allergic reaction and stomach pain to be related to SHINGRIX. Additional details were provided as follows: The patient before having the SHINGRIX vaccine was not having any health issues.   The patient had not had any type of reaction to any previous vaccine. The patient received dose of SHINGRIX in the left arm and she felt very tired later that night. The patient went to bed but woke up feeling tired. The patient ran a slight fever under 100 but started suffering from a horrible pain in her stomach. The patient went to the physician who diagnosed her with diverticulitis. The patient felt it was not diverticulitis as she had it before and this felt different. The patient had not had this type of reaction to any previous vaccines. The patient had been to two physicians and the 2nd physician said that the patient must had a bad allergic reaction to the vaccine and her spleen was totally messed up. The patient was taking an antibiotic and her symptoms seemed to be improving but this had been very disruptive. The patient had also had various tests but all tests come back as nothing being wrong with her. The patient consented to follow up and provided contact details of her physician. Clarification had been raised for the discrepancy between time to event onset. Lab Comments: On an unknown date, the patient had various tests performed but all tests came back as nothing being wrong with her.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test normal, Pyrexia, Spleen disorder
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of diverticulitis in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included diverticulitis. On 9th March 2019, the patient received the 1st dose of SHINGRIX (intramuscular). On 9th March 2019, 7 hrs after receiving SHINGRIX, the patient experienced tiredness. On 10th March 2019, the patient experienced diverticulitis (serious criteria GSK medically significant), fever, allergic reaction, stomach pain and spleen pain. The patient was treated with antibiotics nos (Antibiotic (Drug Name Unknown)). On an unknown date, the outcome of the diverticulitis, tiredness, allergic reaction, stomach pain and spleen pain were recovering/resolving and the outcome of the fever was recovered/resolved. It was unknown if the reporter considered the diverticulitis and spleen pain to be related to SHINGRIX. The reporter considered the tiredness, fever, allergic reaction and stomach pain to be related to SHINGRIX. Additional details were provided as follows: The patient before having the SHINGRIX vaccine was not having any health issues.   The patient had not had any type of reaction to any previous vaccine. The patient received dose of SHINGRIX in the left arm and she felt very tired later that night. The patient went to bed but woke up feeling tired. The patient ran a slight fever under 100 but started suffering from a horrible pain in her stomach. The patient went to the physician who diagnosed her with diverticulitis. The patient felt it was not diverticulitis as she had it before and this felt different. The patient had not had this type of reaction to any previous vaccines. The patient had been to two physicians and the 2nd physician said that the patient must had a bad allergic reaction to the vaccine and her spleen was totally messed up. The patient was taking an antibiotic and her symptoms seemed to be improving but this had been very disruptive. The patient had also had various tests but all tests come back as nothing being wrong with her. The patient consented to follow up and provided contact details of her physician. Clarification had been raised for the discrepancy between time to event onset. Lab Comments: On an unknown date, the patient had various tests performed but all tests came back as nothing being wrong with her.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, VARCEL
Symptoms: Erythema, Injection site cellulitis, Skin warm
Clinical narrative: Red, warm to touch, larger area(5in wx2.5in) area. Told to start Clindamycin, ER Rx'd. Return to clinic in 5 days if worsen go to ER.
Age: 76.0
Sex: M
Vaccine: TDAP
Symptoms: Asthenia, Hypersomnia, Immediate post-injection reaction, Malaise, Pain in extremity
Clinical narrative: Adverse events-Immed felt pain and weakness in all four extremities - no energy/stamina - increased sleeping (12 hrs/day) - reports normal is 10 hrs/day. Treatment -reports received Cortisone injection in LD @ PMD's office some time after. Reported improved energy/stamina and decreased pain. Outcome- states "I am 10% worse off than before the shot". Copy of record given so he can take to his PMD.
Age: 15.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Local reaction
Clinical narrative: SCHOOL NURSE CALLED, CLIENT IN NURSES OFFICE WITH PAIN IN RT ARM.VARICELLA IMMUNIZATION WAS GIVEN IN RT ARM, SQ.NURSE @ SCHOOL CALLED SAID CHILD HAS LOCALIZED REACTION TO VARICELLA. ARM WHERE SHOT GIVEN ABOUT 2 1/2 " FROM ELBOW UP IS RED. REDDNESS IS ABOUT 4 1/2 INCHS LONG BY 4 INCHS WIDE, RAISED ABOUT 1/4 INCH, HOT TO TOUCH, PAINFUL. CHILD CAN MOVE ARM WITHOUT PROBLEMS. NO FEVER. NURSE IS PUTTING ICE ON IT, AND HAVING PARENT BRING IBUPROFEN TO CHILD.
Age: 15.0
Sex: F
Vaccine: IPV, VARCEL
Symptoms: Pain in extremity
Clinical narrative: SCHOOL NURSE CALLED, CLIENT IN NURSES OFFICE WITH PAIN IN RT ARM.VARICELLA IMMUNIZATION WAS GIVEN IN RT ARM, SQ.NURSE @ SCHOOL CALLED SAID CHILD HAS LOCALIZED REACTION TO VARICELLA. ARM WHERE SHOT GIVEN ABOUT 2 1/2 " FROM ELBOW UP IS RED. REDDNESS IS ABOUT 4 1/2 INCHS LONG BY 4 INCHS WIDE, RAISED ABOUT 1/4 INCH, HOT TO TOUCH, PAINFUL. CHILD CAN MOVE ARM WITHOUT PROBLEMS. NO FEVER. NURSE IS PUTTING ICE ON IT, AND HAVING PARENT BRING IBUPROFEN TO CHILD.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Erythema, Injection site reaction, Pain, Rash macular
Clinical narrative: after receiving first dose of Shingrix on Wednesday to her left deltoid. The following day despite taking OTC Tylenol and Ibuprofen for pain experienced a temp of 102.3 requiring that she left work. Reports improvement in localized erythema and warmth. Yesterday she noted a macular pinpoint rash to anterior left upper arm medically without associated pain, itching, warmth.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: after receiving first dose of Shingrix on Wednesday to her left deltoid. The following day despite taking OTC Tylenol and Ibuprofen for pain experienced a temp of 102.3 requiring that she left work. Reports improvement in localized erythema and warmth. Yesterday she noted a macular pinpoint rash to anterior left upper arm medically without associated pain, itching, warmth.
Age: 60.0
Sex: M
Vaccine: TD
Symptoms: Immediate post-injection reaction, Pain in extremity, Paraesthesia
Clinical narrative: Pt is having a lot of pain in right arm and tingling. started right after the shot and continued
Age: 13.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Pallor, Presyncope
Clinical narrative: AFTER IMMUNIZATIONS WERE GIVEN , PT TURNED PALE AND HAD AN EPISODE OF NEAR-SYNCOPE, PLACED ON EXAM TABLE AND OBSERVED. OBSERVED FOR 15 MIN. LUNGS CLEAR, HEART NORMAL, ABDOMEN SOFT, NO MASSES, ALERT & AWAKE, NO IRRITABILITY, NO RASH, NO JAUNDICE, NO LETHARGY. LEFT OFFICE AT 6:20 PM
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Influenza like illness, Nausea, Pyrexia, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea, fever beginning early morning the day after receiving the vaccine. Fever and flu-like symptoms persisted through the next day
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death, Resuscitation, Unresponsive to stimuli
Clinical narrative: Child tolerated administration of vaccines well. Child left office with family after appointment. Our office was notified the following day (5/22/2019) that child died overnight. She was found unresponsive. She was taken to an Emergency Department. Resuscitation was attempted.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Nausea
Clinical narrative: Around 4:00am the morning after receiving the vaccine, I had a terrible headache, chills and nausea. I was unable to take anything for the headache due to the stomach upset. Finally about noon, I was able to eat enough to take some Advil and get some relief. I had a lingering dull headache for most of the day.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Blood test, Chest pain, Computerised tomogram, Echocardiogram
Clinical narrative: By 8:00 that night, I lost the ability to lift my arm and hand. I could not lift it away from my side at all. I had bad pain in from the shoulder to my hand. Through the night the pain starting going across my chest and my back and up into my neck and down my arm, in  a jabbing pain. I could not sleep at all, I went into the ER in the morning, the pain would not stop. I am still fighting with pain my arm and shoulder.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: By 8:00 that night, I lost the ability to lift my arm and hand. I could not lift it away from my side at all. I had bad pain in from the shoulder to my hand. Through the night the pain starting going across my chest and my back and up into my neck and down my arm, in  a jabbing pain. I could not sleep at all, I went into the ER in the morning, the pain would not stop. I am still fighting with pain my arm and shoulder.
Age: 44.0
Sex: F
Vaccine: PPV
Symptoms: Ultrasound scan
Clinical narrative: By 8:00 that night, I lost the ability to lift my arm and hand. I could not lift it away from my side at all. I had bad pain in from the shoulder to my hand. Through the night the pain starting going across my chest and my back and up into my neck and down my arm, in  a jabbing pain. I could not sleep at all, I went into the ER in the morning, the pain would not stop. I am still fighting with pain my arm and shoulder.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: no adverse events gave it  IM instead of subcuataneously
Age: 33.0
Sex: F
Vaccine: MMRV
Symptoms: Hypoaesthesia, Joint stiffness, Joint swelling, Musculoskeletal stiffness, Peripheral swelling
Clinical narrative: Swollen, numb, stiff left knee.  Swollen, numb, stiff left index finger.  Swollen stiff numb right knee.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Lip pruritus, Lip swelling, Paraesthesia oral, Peripheral swelling
Clinical narrative: Patient received 1st dose of Shingrix vaccine on Friday 12/14/18. Patient stated that the next morning she had a rash on her arms and extending to her trunk. The patient does not fully remember details of its appearance but stated it was very itchy and made her quite uncomfortable. She then noticed some swelling in her fingers and lips/face Sunday 12/16/18 afternoon extending into the evening. She stated she noticed it in her hands first but then said her cheeks looked a little puffy. She stated there was also some itching/tingling around her lips that Sunday evening. She took a Benadryl tablet and went to bed, and both the swelling and rash seemed to resolve over the next day. Patient stated that she feels her fingers might still be a little swollen, but denies any discomfort.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Swelling face
Clinical narrative: Patient received 1st dose of Shingrix vaccine on Friday 12/14/18. Patient stated that the next morning she had a rash on her arms and extending to her trunk. The patient does not fully remember details of its appearance but stated it was very itchy and made her quite uncomfortable. She then noticed some swelling in her fingers and lips/face Sunday 12/16/18 afternoon extending into the evening. She stated she noticed it in her hands first but then said her cheeks looked a little puffy. She stated there was also some itching/tingling around her lips that Sunday evening. She took a Benadryl tablet and went to bed, and both the swelling and rash seemed to resolve over the next day. Patient stated that she feels her fingers might still be a little swollen, but denies any discomfort.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Abdominal pain upper, Bone pain, Breast pain, Diarrhoea, Dyspnoea
Clinical narrative: Right away, arm was a little puffy, and had red circle around it. By 1am bones were aching bad. Patient felt like she was going to throw up and stomach was crampy.  Patient reports problems breathing, left breast hurt really bad, and the entire left side hurt. Patient called doctor at 3am and told to take a Benadryl. Patient just rested and aching would come and go. In the morning, patient woke up and had diarrhea and then 2 hours later vomited. Patient reports having diarrhea since.  Patient called doctor again and  took Imodium, take Benadryl as needed and stay on a bread diet.  Patient told to call back on Tuesday if not feeling better and continue to drink plenty of fluids.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Flank pain, Nausea, Peripheral swelling, Vomiting
Clinical narrative: Right away, arm was a little puffy, and had red circle around it. By 1am bones were aching bad. Patient felt like she was going to throw up and stomach was crampy.  Patient reports problems breathing, left breast hurt really bad, and the entire left side hurt. Patient called doctor at 3am and told to take a Benadryl. Patient just rested and aching would come and go. In the morning, patient woke up and had diarrhea and then 2 hours later vomited. Patient reports having diarrhea since.  Patient called doctor again and  took Imodium, take Benadryl as needed and stay on a bread diet.  Patient told to call back on Tuesday if not feeling better and continue to drink plenty of fluids.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash, Skin lesion
Clinical narrative: This spontaneous report was received from a lawyer regarding a case in litigation and refers to a female patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 20-FEB-2015, the patient was vaccinated with ZOSTAVAX for its intended purpose: the prevention of shingles (lot number, dosage and route of administration not provided). As a direct result of ZOSTAVAX, the patient suffered from a shingles outbreak, in addition to chronic pain, rash and lesions to various parts of the body. The pt did not have a shingles outbreak until 11-SEP-2017. As a direct result of the ZOSTAVAX, the pt suffered mental and emotional distress due to resulting physical limitations and the seriousness of her condition. As a result of ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The outcome of the event was considered to be not recovered. Shingles outbreak was considered to be disabling. Additional information has been requested.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Decreased appetite, Hypersomnia, Irritability, Lethargy, Pyrexia
Clinical narrative: 4 days after receiving the vaccine Patient became fussy, rapid respirations, fever, lethargic, sleeping a lot, running nose, and decreased appetite.  RVP negative and twin sister with no symptoms.
Age: 1.25
Sex: F
Vaccine: VARCEL
Symptoms: Respiratory rate increased, Respiratory viral panel, Rhinorrhoea
Clinical narrative: 4 days after receiving the vaccine Patient became fussy, rapid respirations, fever, lethargic, sleeping a lot, running nose, and decreased appetite.  RVP negative and twin sister with no symptoms.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus generalised
Clinical narrative: Patient developed generalized pruritus after receiving vaccine.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Culture throat, Dysphagia, Gait disturbance, Headache, Injection site erythema
Clinical narrative: Patient started having severe bifrontal headache, bilateral leg muscle pain, sore throat, and localized redness and pain at the site of injection about two hours after the shot.  Symptoms became progressively worse over the next seven days, especially in the past two days, when she felt her throat was swelling up and had difficulty  in swallowing.  The pain in her thigh muscles was so severe that she almost couldn't walk.  She took Advil 200 mg every 6 hours a couple of times a day with minimal relief.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site pain, Myalgia, Oropharyngeal pain, Pharyngeal swelling
Clinical narrative: Patient started having severe bifrontal headache, bilateral leg muscle pain, sore throat, and localized redness and pain at the site of injection about two hours after the shot.  Symptoms became progressively worse over the next seven days, especially in the past two days, when she felt her throat was swelling up and had difficulty  in swallowing.  The pain in her thigh muscles was so severe that she almost couldn't walk.  She took Advil 200 mg every 6 hours a couple of times a day with minimal relief.
Age: 15.0
Sex: F
Vaccine: MMR
Symptoms: Emotional distress, Loss of consciousness, Posture abnormal, Syncope
Clinical narrative: Patient slouched and slowly rolled from a sitting position in the chair to the floor.  (Vasovagal syncope)  She laid on her stomach for a few seconds before starting to speak and a minute or two before getting back in the chair.  After sitting for about 20 or 30 minutes with her mother and myself, she was able to walk.  She did have an emotionally response after coming to.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness and swelling around injection site; hot to the touch.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Erythema, Pain in extremity, Pyrexia
Clinical narrative: achy joints fever 100.7, sore red arm
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Glossodynia, Injection site pain, Insomnia, Oropharyngeal pain
Clinical narrative: patient reported that the next day after vaccine administration his body was itching all over including skin on the scalp. he started taking some loratadine 10 mg qd. but his body itch is still there and comes and goes. he also reported that his tongue feels stinging sensation or feeling like burning and his throat is having stinging pain. he also sais that some mornings he feels shortness of breath and wheeze but no mucus coming out. he also stated that his injection site still hurts.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus, Pruritus generalised, Tongue discomfort, Wheezing
Clinical narrative: patient reported that the next day after vaccine administration his body was itching all over including skin on the scalp. he started taking some loratadine 10 mg qd. but his body itch is still there and comes and goes. he also reported that his tongue feels stinging sensation or feeling like burning and his throat is having stinging pain. he also sais that some mornings he feels shortness of breath and wheeze but no mucus coming out. he also stated that his injection site still hurts.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Fever, body aches, headache
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal distension, Diarrhoea, Lip swelling, Rash generalised, Urticaria
Clinical narrative: Vaccine was taken on May 14, 2019. Severe rash (hives) all over the body with severe itching, severe stomach bloating with diarrhea, lower lip swelling after 30 hours (on May 15, 2019) after the vaccine was taken .  This is the 2nd dose taken.  (The first dose was taken in May 2018 with minor feverish feeling and body pains).   The second dose only caused severe reaction.  Had to take Prednisone -6 day course  starting on May 17, 2019 (4th day after the second dose of the vaccine).  Then the reactions gradually diminished.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Muscle contracture, Muscle tightness, Pain
Clinical narrative: patients muscle became tense and stayed contracted for long period of time. Intense pain started around 6 hours after vaccination so she went to the ER around 12 hours after vaccination.   ER physician said that it was just normal pain and there was no severe reaction. Intense pain lasted into today so she went to her normal doctor and doctor treated her with a pain medication. PCP told her that pain will go away over a few days.
Age: 17.0
Sex: F
Vaccine: HEP, HPV9
Symptoms: Blood test, Injury associated with device
Clinical narrative: While administering immunizations, Used finger instead of table to put safety guard on the needle. Needle stuck left pointer finger. Unsure of which vaccination was given during incident. I listed them both.
Age: 15.0
Sex: M
Vaccine: HEPA, TYP
Symptoms: Feeling hot, Flushing, Neck pain
Clinical narrative: Patient received both vaccines and stated of feeling warm, and complaint of neck pain. Vital signs post vaccines 103/69 o2 sat 99 p97 resp 16 Patient did not faint, but remained flushed and monitored. VS  20 minutes post vaccines stable BP131/94 P72 O2 SAT 99 resp 16
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: fever, and red swollen R arm
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: He then got the Shingles 2 months later
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash vesicular
Clinical narrative: blistering rash that appeared within 2 days of being given the vaccine
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Pruritus, Tremor
Clinical narrative: blistering rash that appeared within 2 days of being given the vaccine
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Nausea, Pyrexia
Clinical narrative: Approximately 16 hours after my Shingrix vaccine was administered, I began feeling nauseous and had an elevated temperature. 24 hours post vaccine, my fever registered at 101.7, orally.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Grip strength decreased, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: 9/16/18 Went to pharmacy. Shindrex vaccine was given on upper left arm. Within 1 hour after, I felt puffiness, redness and hardness on injection sight & to the left of injection sight. The pharmacy stated that it will go away after 3 days. It did start going away with in that time frame. Around 9/17/18 I felt a burning pain started from the left middle finger all the way up my left arm and up to my neck. On 9/18/18 I felt burning pain and tingling in both arms. The next night on 9/19/18 I felt the same burning pain and tingling and could not sleep for 3 nights in a row, I continued to have swelling in my fingers, stiffness and pain, and sometimes unable to close my hands. At night the pain is so severe that I have to get out of bed and either take pain medication, stretch, massage and drink nettle tea, tart cherry etc, in an attempt to relieve the pain. The pain is still a daily intermittent occurrence but worse at night, on the injection sight and in both arms. Mostly in the right hand and weakness in both hands. I  can not sleep most nights. Sometimes I can feel pain throughout my body.
Age: 77.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Musculoskeletal stiffness, Nuclear magnetic resonance imaging, Pain, Paraesthesia
Clinical narrative: 9/16/18 Went to pharmacy. Shindrex vaccine was given on upper left arm. Within 1 hour after, I felt puffiness, redness and hardness on injection sight & to the left of injection sight. The pharmacy stated that it will go away after 3 days. It did start going away with in that time frame. Around 9/17/18 I felt a burning pain started from the left middle finger all the way up my left arm and up to my neck. On 9/18/18 I felt burning pain and tingling in both arms. The next night on 9/19/18 I felt the same burning pain and tingling and could not sleep for 3 nights in a row, I continued to have swelling in my fingers, stiffness and pain, and sometimes unable to close my hands. At night the pain is so severe that I have to get out of bed and either take pain medication, stretch, massage and drink nettle tea, tart cherry etc, in an attempt to relieve the pain. The pain is still a daily intermittent occurrence but worse at night, on the injection sight and in both arms. Mostly in the right hand and weakness in both hands. I  can not sleep most nights. Sometimes I can feel pain throughout my body.