chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: shingles; Rash; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 58-year-old female patient who received Herpes zoster (Shingrix) (batch number D9474, expiry date 19th March 2020) for prophylaxis.   The patient's past medical history included rash.   On 19th March 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced shingles and rash. On an unknown date, the outcome of the shingles and rash were unknown.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The patient was vaccinated on left arm. The patient reported that she had a rash prior to receiving Shingrix. On an unknown date, Several days after the injection, the patient went to see the physician for her rash and was diagnosed as having shingles. It was not known if the preexisting rash prior to the injection was confirmed as shingles. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain
Clinical narrative: Red area (5 inches across); soreness; This case was reported by a other health professional via call center representative and described the occurrence of erythema in a 75-year-old female patient who received Herpes zoster (Shingrix) (batch number MP42R, expiry date 19th September 2021) for prophylaxis.   On 11th June 2019, the patient received Shingrix. In June 2019, less than a month after receiving Shingrix, the patient experienced erythema and pain. On an unknown date, the outcome of the erythema was recovering/resolving and the outcome of the pain was unknown.   It was unknown if the reporter considered the erythema and pain to be related to Shingrix.  Additional details were provided as follows: The health care professional reported that the patient received 1st dose and reported red area of 5 inches, soreness, then red area shrunk to 3 inches a couple of days later. The pharmacy intern asked how to proceed in the future with 2nd dose.
Age: 5.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site reaction, Skin lesion
Clinical narrative: Adverse event: erythema, previously related lesion on R anterior proximal thigh 6cmx4cm in size. No airway involvement. Treatment: 12.5mg Benadryl q6 hrs, Motrin qHS Disposition: likely full resolution of sx's in 3 days
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Croup infectious, Full blood count, Influenza virus test negative, Monocyte count increased, Otitis media acute
Clinical narrative: Patient had prolonged fever (8 days) after receiving first Hepatits A (Vaqta) vaccine. Seen twice by providers and thought to be viral.  Received booster dose of Hepatitis A (Vaqta) 6 months later and again had prolonged fever after vaccination ( approx 5 days). Was also diagnosed with droup, sinusitis and left otitis media 5 days after vaccination, during prolonged fever.
Age: 1.5
Sex: M
Vaccine: HEPA
Symptoms: Pyrexia, Respiratory syncytial virus test negative, Sinusitis
Clinical narrative: Patient had prolonged fever (8 days) after receiving first Hepatits A (Vaqta) vaccine. Seen twice by providers and thought to be viral.  Received booster dose of Hepatitis A (Vaqta) 6 months later and again had prolonged fever after vaccination ( approx 5 days). Was also diagnosed with droup, sinusitis and left otitis media 5 days after vaccination, during prolonged fever.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Pyrexia
Clinical narrative: Injection site soreness ~~ resolved with time Chills ~~ 8:30 pm (6/26) to 7 am (6/27) resolved with time Fever ~~ 100.1 (1am thru 7 am) 6/27 ~~ resolved with Tylenol and time
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Loss of consciousness, Muscle contractions involuntary
Clinical narrative: 30-40 minutes after vaccine was given patient felt light headed and when checking out she passed out and had a slight contraction which may have been seizure activity 5-10 seconds
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Hyperhidrosis, Pain
Clinical narrative: Dizziness, sweating, fatigue, achiness,
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Myalgia, Pyrexia
Clinical narrative: Myalgias, arthralgias, chills, fever starting 10 hours after injection, lasting 3 hours until taking ibuprofen which reduced symptoms after about 45 minutes.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Meibomian gland dysfunction
Clinical narrative: Since vaccine I have encountered Meibomian (MGD) in both eyes, one oil duct in each eye.  Prior to vaccine I had not had any incidences of MGD.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Patient went home and developed chills later that night. The pt felt fever-ish and achy a few hours after the vaccine wwas administered . The chills did not last long, just throughout the night.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Sinus disorder, Tooth disorder
Clinical narrative: shingles outbreak; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (battling for years). Previously administered products included Zostavax.   On 1st February 2019, the patient received the 1st dose of Shingrix. On 11th February 2019, 10 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: Ten days later after receiving Shingrix, the patient developed a flare up of his teeth and sinus cavities. The patient believed that it was a Shingrix outbreak. The patient was a dual transplant patient and has been battling shingles for years. The reporter gave consent to follow up. For tolerance to 2nd dose of Shingrix, refer case US2019AMR115698.
Age: 5.0
Sex: M
Vaccine: DTAPIPVHIB, IPV, MMR, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Incorrect vaccine given:  PENTACEL MNF: Sanofi L# UJ102AAA Given IM Right Delt. Dose 0.5ML Order was for DTAP
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Fatigue, Influenza like illness, Injection site pain
Clinical narrative: Sore arm within minutes, but not incapacitating.  No bruising, but minor swelling at point of injection.  Sore knee joints, back, wrists, and ankles within 2 hours.  Walking painful; felt like severe flu.  Severe tiredness for 48 hours.  Fever, sores in mouth and swollen tongue at 60 hours from injection.  Currently at 68 hours after injection.  Swollen tongue, fever and aches receding.  Arm still slightly sore to touch at point of injection.  Feeling better and less tired.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pain in extremity, Pyrexia, Stomatitis
Clinical narrative: Sore arm within minutes, but not incapacitating.  No bruising, but minor swelling at point of injection.  Sore knee joints, back, wrists, and ankles within 2 hours.  Walking painful; felt like severe flu.  Severe tiredness for 48 hours.  Fever, sores in mouth and swollen tongue at 60 hours from injection.  Currently at 68 hours after injection.  Swollen tongue, fever and aches receding.  Arm still slightly sore to touch at point of injection.  Feeling better and less tired.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Swollen tongue
Clinical narrative: Sore arm within minutes, but not incapacitating.  No bruising, but minor swelling at point of injection.  Sore knee joints, back, wrists, and ankles within 2 hours.  Walking painful; felt like severe flu.  Severe tiredness for 48 hours.  Fever, sores in mouth and swollen tongue at 60 hours from injection.  Currently at 68 hours after injection.  Swollen tongue, fever and aches receding.  Arm still slightly sore to touch at point of injection.  Feeling better and less tired.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Heart rate increased, Pain in extremity
Clinical narrative: Chills/Shivers, sore arm, fast heart beat
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Swelling at sight of injection, slight  nausea, shivering, slight headache, muscle soreness at sight of injection
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Patient had redness and swelling and hives around injection site and the patient was treated with Benadryl and an ice pack to help with symptoms
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: red area on arm ..pt said sore and warm to touch.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Herpes zoster; This initial spontaneous report regarding a case in litigation was received from a lawyer, a male patient of unknown age, and his spouse. No information was provided regarding the patient's medical history, concurrent conditions, or concomitant medications. On an unknown date in 2014, at approximately 70 years of age, the male patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, and route of administration not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient was treated by a healthcare provider for the following injury resulting from his zoster vaccine live (ZOSTAVAX) use: Herpes zoster. The outcome of the herpes zoster was not provided.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Injection site bruising, Mobility decreased, Peripheral swelling
Clinical narrative: could not move the extremity; swelling from the arm; bruising from the injection site down to her elbow; headache; This spontaneous report has been received from a registered nurse via an employee referring to a 70 years old female patient. The patient did not have any concomitant medication or drug reactions/allergies. Pertinent medical history included autoimmune deficiency.   On 14-JUN-2019 (at 09:00 am), the patient was vaccinated with a dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (lot # R031812, expiration date 26-SEP-2020; dose was unknown) subcutaneously in the right arm to prevent pneumonia.         On 14-JUN-2019 (by 16:00 pm), the patient called the doctor's office to report that she experienced a headache, swelling from the arm and could not move the extremity. The patient also reported bruising from the injection site down to her elbow. The patient did not sink medical attention. No treatment was given for the events. No lab diagnostics/studies were performed. The patient recovered from all the events on 16-JUN-2019 (reported as within 2 days). The causality between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was unknown. No product quality complaint (PQC) presented.
Sex: F
Vaccine: MENB
Symptoms: Adverse reaction
Clinical narrative: bad reaction; This case was reported by a consumer via interactive digital media and described the occurrence of adverse reaction in a female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Bexsero.  Additional information was provided as follows: The age at vaccination was not reported. The patient received Bexsero and experienced bad reaction.
Sex: U
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: cold sores; This case was reported by a other health professional via call center representative and described the occurrence of cold sores in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced cold sores. On an unknown date, the outcome of the cold sores was unknown.   It was unknown if the reporter considered the cold sores to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient expereinced cold sores after receiving a dose of Shingrix.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Ophthalmic herpes zoster
Clinical narrative: shingles outbreak mouth and on eyelid; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (battling for years). Previously administered products included Shingrix (1st dose received on 1st February 2019, refer case US2019109577) and Zostavax.   In June 2019, the patient received the 2nd dose of Shingrix. In June 2019, less than a month after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had his Shingrix 10 days before the reporting date and had an outbreak in his mouth and on his eyelid. The patient was a dual transplant patient and has been battling shingles for years. The reporter consented to follow up.
Age: 13.0
Sex: F
Vaccine: HEPA
Symptoms: Burning sensation, Incorrect dose administered
Clinical narrative: it burned a little; Overdose; wrong age indication; This case was reported by a pharmacist via call center representative and described the occurrence of burning sensation in a 13-year-old female patient who received HAV (Havrix adult) (batch number PZ353, expiry date 21st November 2020) for prophylaxis.   On an unknown date, the patient received Havrix adult. On an unknown date, unknown after receiving Havrix adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.  Additional details were provided as follows: A 13 year old patient received an adult dose of Havrix, which led to overdose and adult product administered to child. The pharmacist consented to follow up.   Follow up information received from pharmacist on 2nd January 2019: The patient's demographic details were updated. On 31st October 2018, the patient received 1st dose of Havrix adult intramuscularly. The patient had no adverse event after receiving Havrix adult. This was a medication error without harm. The VAERS details were updated.   Follow up information was received from pharmacist on 20th June 2019: The patient stated that less than a year after inadvertantly receiving adult dose of Havrix it burned a little more. It was unknown if the reporter considered burning sensation was related to Havrix adult. The outcome of the event felt like burning was unknown.
Age: 56.0
Sex: M
Vaccine: HEPAB
Symptoms: Blood immunoglobulin M increased, Hepatitis A, Hepatitis B core antibody negative, Hepatitis B surface antibody positive, Hepatitis B surface antigen negative
Clinical narrative: Hepatitis A Infection; This case was reported by a other health professional via call center representative and described the occurrence of hepatitis a in a 56-year-old male patient who received HAB (Twinrix) (batch number 3C422, expiry date 30th April 2021) for prophylaxis.   On 27th March 2019, the patient received the 2nd dose of Twinrix. On an unknown date, less than a year after receiving Twinrix, the patient experienced hepatitis a. On an unknown date, the outcome of the hepatitis a was unknown.   It was unknown if the reporter considered the hepatitis a to be related to Twinrix.  Additional details were provided as follows: The physician assistant reported that the patient received the 2nd dose of the vaccination at the end of March and the labs report showed immunoglobulin M increased. The physician assistant indicated that the elevated IgM levels were in reference to hepatitis A. On 17th June 2019, the additional lab values indicated that the patient's Hepatitis total IgG and the Hepatitis B IgG are both positive. The reporter also stated in regards to the Hepatitis B testing, the surface antibody was positive, but the core and surface antigen were negative.      Lab Comments: On 17th June 2019, the patient's Hepatitis total IgG and the Hepatitis B IgG are both positive. Reporter continues that in regards to the Hepatitis B testing, the surface antibody was positive, but the core and surface antigen were negative.
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B antibody negative, Therapy non-responder
Clinical narrative: Not resistant; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a adult female patient who received HBV (Engerix B) for prophylaxis.   On an unknown date, the patient received Engerix B at an unknown dose. On an unknown date, unknown after receiving Engerix B, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Engerix B.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient received the Hepatitis-B series as a child and was not Hepatitis-B resistant. The reporter mentioned that the patient heard that the vaccines from the 90's were not resistant and need to repeat the series. The patient started rotation in a month, and would like to know what are her choices. The reporter was unsure whether the Hepatitis-B vaccine given was Engerix-b or not. No additional information was provided.      Lab Comments: On an unknown date lab test was performed
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingles vaccine. Concurrent medical conditions included neurological disorder nos, back disorder and allergy.   On an unknown date, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient had been receiving allergy and serum shots as he was allergic to 49 different things. He also had the original Shingles shot in the past.  The patient received the first dose of Shingrix vaccine about 3 months ago in the left arm.  The patient experienced a sore arm with it. He did not remember how long it lasted but he recovered from the sore arm. The reporter had consented to follow up. No further details were provided. This case has been linked with the case US2019AMR115561, reported by same reporter for same patient.
Sex: F
Vaccine: MEN
Symptoms: Pyrexia, Tremor
Clinical narrative: shaking; fever; This case was reported by a consumer via call center representative and described the occurrence of tremor in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced tremor and fever. On an unknown date, the outcome of the tremor and fever were unknown.   It was unknown if the reporter considered the tremor and fever to be related to Meningococcal B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient was mother of an 18 year old daughter. The patient expereinced shaking and fever after receiving a dose of Meningitis vaccine. The reporter stated that, it was unknown which Meningitis vaccine or manufacturer was given.  In database Meningococcal B vaccine was given. As it was unknown which Meningitis vaccine was patient had received, kept as reported.
Sex: U
Vaccine: MENB
Symptoms: Dizziness, Headache, Influenza like illness, Injection site pain, Pain
Clinical narrative: Complained of flu like symptoms days after receiving 1st dose of Trumenba; Headache; Sore at injection site; Dizziness; Generalized pain; This is a spontaneous report from a non-contactable consumer via a Pfizer Sales Representative. This consumer reported similar events for four patients. This is the first of four reports.   A patient of unspecified age and gender received the first dose of meningococcal group b rlp2086 (TRUMENBA; lot number AL8468) via an unspecified route of administration on an unspecified date at single dose for immunisation. Relevant medical history and concomitant medications were not reported. On an unspecified date, the patient complained of flu like symptoms, headache, sore at injection site, dizziness and generalized pain. The outcome of the events was unknown. Office said they have seen this in the past where every patient who got a TRUMENBA complained of side effects, then that lot number finished, and they used another lot number and they heard anything from patients about side effects. They were starting to hear more complaints and wonder if it was the vaccines associated with specific lot numbers.  No follow-up attempts are possible. No further information is expected. ; Sender's Comments: Linked Report(s) : US-PFIZER INC-2019272004 same reporter, different patient.;US-PFIZER INC-2019272005 same reporter, different patient.;US-PFIZER INC-2019272006 same reporter, different patient.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Mobility decreased, Peripheral swelling
Clinical narrative: Severe swelling and redness that ran down the arm to the elbow; Severe swelling and redness that ran down the arm to the elbow; Patient couldn't lift arm; This is a spontaneous report from a contactable nurse via a Pfizer sales representative. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA; lot number unknown), 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 unknown date after the use of the product, the patient experienced severe swelling and redness that ran down the arm to the elbow. Patient could not lift arm and had to take BENADRYL for 3 days. The outcome of the events was unknown.  No follow-up attempts are possible, information on the batch number could not be obtained. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling pain and redness at injection site right arm; Swelling pain and redness at injection site right arm; Swelling pain and redness at injection site right arm; This is a spontaneous report from a contactable physician via a Pfizer sales representative. A female patient of an unspecified age (Age: 65; Unit: Unknown) received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) (PREVNAR 13; lot number unknown), via an unspecified route of administration in right arm in 2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient experienced swelling pain and redness at injection site right arm on an unspecified date. The outcome of the events was unknown.  No follow up attempts are possible, information on the batch number could not be obtained. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Arthralgia, Chills, Injection site pain, Myalgia, Pain in extremity
Clinical narrative: Her whole arm hurt right at the injection place; Chills; Muscles and joints aches; Pains; This is a spontaneous report from a contactable pharmacist.  A 17-year-old female patient started to receive meningococcal group b rlp2086 (TRUMENBA, Lot Number: AL8468 and expiration date: Feb2021), via an unspecified route of administration in May2019 (a month ago), at a single dose for immunization. There were no relevant medical history nor concomitant medications. After the administration, the patient's whole arm hurt right at the injection place and then the next day she had chills, muscles and joints aches and pains which was considered as the side effect but she said she threw up after that for 2 days in May2019, patient was not sure  if it was due to the vaccine or if it was just stress. In addition, it was also reported that the caller came back and rejected it as a booster, said that it was a booster vaccine and they rejected this. The patient's mom came in with a paper work from the college for which the patient needed a booster to go the college. The patient's mother  was advised to put ice on the injection site if it's still hurt or she needed to take a acetaminophen (TYLENOL). Outcome of the events was unknown.
Sex: F
Vaccine: MENB
Symptoms: Vomiting
Clinical narrative: Her whole arm hurt right at the injection place; Chills; Muscles and joints aches; Pains; This is a spontaneous report from a contactable pharmacist.  A 17-year-old female patient started to receive meningococcal group b rlp2086 (TRUMENBA, Lot Number: AL8468 and expiration date: Feb2021), via an unspecified route of administration in May2019 (a month ago), at a single dose for immunization. There were no relevant medical history nor concomitant medications. After the administration, the patient's whole arm hurt right at the injection place and then the next day she had chills, muscles and joints aches and pains which was considered as the side effect but she said she threw up after that for 2 days in May2019, patient was not sure  if it was due to the vaccine or if it was just stress. In addition, it was also reported that the caller came back and rejected it as a booster, said that it was a booster vaccine and they rejected this. The patient's mom came in with a paper work from the college for which the patient needed a booster to go the college. The patient's mother  was advised to put ice on the injection site if it's still hurt or she needed to take a acetaminophen (TYLENOL). Outcome of the events was unknown.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, muscle soreness (right arm), fever, chills
Age: 4.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Discomfort, Gait disturbance, Injection site cellulitis, Injection site joint effusion, Injection site joint erythema
Clinical narrative: Per Mother: Patient complained of discomfort and had been limping 6-25-6/26. On the evening of 6/26 mother noticed large area of redness, warmth to touch, and swelling to the right knee and took him to Urgent Care. Urgent Care referred patient to the ER. Patient diagnosed with right knee effusion, cellulitis, and given oral clindamycin. Today patient is no longer limping and warmth to ouch has decreased per mother.
Age: 4.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Injection site joint swelling, Injection site joint warmth
Clinical narrative: Per Mother: Patient complained of discomfort and had been limping 6-25-6/26. On the evening of 6/26 mother noticed large area of redness, warmth to touch, and swelling to the right knee and took him to Urgent Care. Urgent Care referred patient to the ER. Patient diagnosed with right knee effusion, cellulitis, and given oral clindamycin. Today patient is no longer limping and warmth to ouch has decreased per mother.
Age: 1.42
Sex: M
Vaccine: VARCEL
Symptoms: Injection site discomfort, Injection site induration, Injection site swelling
Clinical narrative: Slight swelling around injection site and small hard bump where needle went in. No fever. Mild discomfort.
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Cervical dysplasia, Exposure during pregnancy, Prenatal screening test, Smear cervix abnormal, Ultrasound antenatal screen
Clinical narrative: Low grade squamous intraepithelial lesion; Abnormal pap smear; Vaccine exposure during pregnancy; This is a serious observational study case, initially received from other health professional on 18-Jun-2019, concerning a 22-year-old adult female, pregnant subject, of height: 63 inches, body weight: 136 lbs, body mass index (BMI): 24.1, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine during pregnancy.  The subject's obstetrical history noted that the subject did not have any previous pregnancy. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal or paternal history with major congenital malformations. The subject's concomitant medication included Prenatal vitamins (minerals NOS, vitamins NOS) as supplement.   The subject's last menstrual period (LMP) date was 15-Oct-2018. The type of pregnancy was singleton. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The pregnancy status of the subject was collected and there were no complications noted.  On 14-Dec-2018, the subject was administered Flu Vaccine Egg Split QIV CSL [influenza vaccine, batch number: YF42609, dose, route of administration, anatomical location, expiry date: not reported] (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.  On the same day, after vaccination, the subject underwent pap smear test which showed low grade squamous intraepithelial lesion (pap smear abnormal). The subject also underwent prenatal ultrasound and no major congenital malformations were noted.   On 11-Jan-2019, the subject underwent prenatal test (sequential 1) and Nuchal Translucency and no major congenital malformations were noted.  On 08-Feb-2019, the subject underwent prenatal test (sequential 2) and no major congenital malformations were noted.   The outcome of the event low grade squamous intraepithelial lesion was not recovered.  The subject's corrected expected delivery date (CEDD) was reported as 22-Jul-2018 and expected delivery date (EDD) was reported as 23-Jul-2019 and; Reporter's Comments: A 22-year-old female pregnant subject was diagnosed with low grade squamous intraepithelial lesion by pap smear test (pap smear abnormal), on the same day after receipt of Flu Vaccine Egg Split QIV (considered as vaccine exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported event low grade squamous intraepithelial lesion, the company assessed the causality as not related to study vaccine. The event vaccine exposure during pregnancy assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
Age: 22.0
Sex: F
Vaccine: UNK
Symptoms: Ultrasound antenatal screen normal
Clinical narrative: Low grade squamous intraepithelial lesion; Abnormal pap smear; Vaccine exposure during pregnancy; This is a serious observational study case, initially received from other health professional on 18-Jun-2019, concerning a 22-year-old adult female, pregnant subject, of height: 63 inches, body weight: 136 lbs, body mass index (BMI): 24.1, enrolled in a prospective observational safety study on pregnancy outcomes in women immunized with Afluria QIV, a seasonal quadrivalent vaccine during pregnancy.  The subject's obstetrical history noted that the subject did not have any previous pregnancy. The subject had no history of offspring with major congenital malformation. Also, the subject had no maternal or paternal history with major congenital malformations. The subject's concomitant medication included Prenatal vitamins (minerals NOS, vitamins NOS) as supplement.   The subject's last menstrual period (LMP) date was 15-Oct-2018. The type of pregnancy was singleton. The subject did not have a prior history of use of tobacco, alcohol or illicit drugs during pregnancy. The pregnancy status of the subject was collected and there were no complications noted.  On 14-Dec-2018, the subject was administered Flu Vaccine Egg Split QIV CSL [influenza vaccine, batch number: YF42609, dose, route of administration, anatomical location, expiry date: not reported] (explicitly coded as vaccine exposure during pregnancy) for an unknown indication.  On the same day, after vaccination, the subject underwent pap smear test which showed low grade squamous intraepithelial lesion (pap smear abnormal). The subject also underwent prenatal ultrasound and no major congenital malformations were noted.   On 11-Jan-2019, the subject underwent prenatal test (sequential 1) and Nuchal Translucency and no major congenital malformations were noted.  On 08-Feb-2019, the subject underwent prenatal test (sequential 2) and no major congenital malformations were noted.   The outcome of the event low grade squamous intraepithelial lesion was not recovered.  The subject's corrected expected delivery date (CEDD) was reported as 22-Jul-2018 and expected delivery date (EDD) was reported as 23-Jul-2019 and; Reporter's Comments: A 22-year-old female pregnant subject was diagnosed with low grade squamous intraepithelial lesion by pap smear test (pap smear abnormal), on the same day after receipt of Flu Vaccine Egg Split QIV (considered as vaccine exposure during pregnancy). Considering the implausible temporal relationship between vaccination and reported event low grade squamous intraepithelial lesion, the company assessed the causality as not related to study vaccine. The event vaccine exposure during pregnancy assessed as not related considering the intended use of the vaccine. The company assessed the case as serious (medically significant).
Age: 96.0
Sex: M
Vaccine: VARZOS
Symptoms: Agitation, Cerebrovascular accident, Computerised tomogram normal, Confusional state, Differential white blood cell count
Clinical narrative: on 5/30 Patient was found unresponsive at home by spouse and daughter. Transported by EMS to local Emergency Department. Preliminary diagnosis was stroke and tPA was initiated. Patient than transferred to ICU for monitoring. Physical exam performed in ICU. Neurologically Patient was awake, confused, and agitated but no evidence of peripheral deficits was found. CT imaging showed no hemorrhage, extensive small vessel changes, and possible ischemia. MRI showed no acute intracranial findings. Patient continued to improve during stay and was discharged on 6/4. Syncope ALTEPLASE 100 MG ONCE ,LEVETIRACETAM 500 MG Unknown
Age: 96.0
Sex: M
Vaccine: VARZOS
Symptoms: Full blood count, Haematocrit decreased, Haemoglobin decreased, Intensive care, Nuclear magnetic resonance imaging normal
Clinical narrative: on 5/30 Patient was found unresponsive at home by spouse and daughter. Transported by EMS to local Emergency Department. Preliminary diagnosis was stroke and tPA was initiated. Patient than transferred to ICU for monitoring. Physical exam performed in ICU. Neurologically Patient was awake, confused, and agitated but no evidence of peripheral deficits was found. CT imaging showed no hemorrhage, extensive small vessel changes, and possible ischemia. MRI showed no acute intracranial findings. Patient continued to improve during stay and was discharged on 6/4. Syncope ALTEPLASE 100 MG ONCE ,LEVETIRACETAM 500 MG Unknown
Age: 96.0
Sex: M
Vaccine: VARZOS
Symptoms: Red blood cell count decreased, Red blood cell sedimentation rate increased, Syncope, Unresponsive to stimuli
Clinical narrative: on 5/30 Patient was found unresponsive at home by spouse and daughter. Transported by EMS to local Emergency Department. Preliminary diagnosis was stroke and tPA was initiated. Patient than transferred to ICU for monitoring. Physical exam performed in ICU. Neurologically Patient was awake, confused, and agitated but no evidence of peripheral deficits was found. CT imaging showed no hemorrhage, extensive small vessel changes, and possible ischemia. MRI showed no acute intracranial findings. Patient continued to improve during stay and was discharged on 6/4. Syncope ALTEPLASE 100 MG ONCE ,LEVETIRACETAM 500 MG Unknown
Age: 75.0
Sex: M
Vaccine: SMALL
Symptoms: Arthralgia, Headache, Myalgia, Pyrexia
Clinical narrative: Fever of 99.7degrees F for about 36 hours Bad headache Muscle and joint pain
Age: 26.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported localized redness, swelling, and warmth at the area. No other symptoms were noted.  Redness and swelling has decreased since 06/23/2019, but partially remains. Warmth has resolved.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillian Barre Syndrome. See attached records.
Age: 16.0
Sex: F
Vaccine: HPV4, MENB, MNQ
Symptoms: Injection site rash, Rash, Skin lesion
Clinical narrative: pt seen in office on 5-23-19 states - rash started on Rt deltoid 2 days after getting shots - rash lesions spread to back & groin during the following week.   pt was given Hydrocortisone 2.5% ointment & Zyrtec Allergy childrens 10mg oral tablet.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Myalgia, Pyrexia
Clinical narrative: Fever,  significant muscle and joint pain, lack of energy
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pyrexia, Vomiting
Clinical narrative: Bruise started day of administration. 12 days later, 6/27/19, pt began experiencing strong signs of fever with vomiting - bruise is still present though diminishing and not painful. Recommended to treat fever symptoms with Tylenol, illness is possible but not likely due to reaction to vaccine because of time span.
Age: 14.0
Sex: F
Vaccine: HPV9, MENB, MNQ
Symptoms: Syncope
Clinical narrative: Pt had episode of syncope.
Age: 18.0
Sex: F
Vaccine: HEPA, HPV9, MNQ
Symptoms: Loss of consciousness, Malaise, Pallor, Syncope
Clinical narrative: Patient experienced syncope several minutes after receiving these three immunizations. Lost consciousness for several seconds before coming back into consciousness. Nurse recognized pt. was getting pale and not feeling well before syncope occurred, so patient was sitting at time of incident and no falling injury occurred. Emergency services were called and paramedics dispatched to assess patient before releasing her to leave with her parents. Pt. was alert and oriented after regaining consciousness and blood pressure and pulse were within normal range.
Age: 88.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypotonia, Mobility decreased, Muscular weakness, Musculoskeletal disorder, Pain in extremity
Clinical narrative: The patient called the pharmacy on 6/26/19 to report that she experienced a pain and weakness in her right arm.  She said the pain and weakness began about an hour after the vaccine and had begun to resolve by the time she called.  She described the pain as severe. She said her entire arm was limp and she was unable to use her fingers.  By the time she called she had use of her fingers but she could not raise her arm comfortably.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Irritability
Clinical narrative: Patients mom called back later in the day to report redness and swelling  of about 6cm at the injection site. No Fever but has been taking Tylenol. Area is sensitive to touch and he is fussy.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: rash chest torso back , non pruritic x 3 d
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: shivers; fatigue; injection site warmth; injection site swelling; injection site pain; This case was reported by a consumer via call center representative and described the occurrence of shivers in a 67-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a day after receiving Shingrix, the patient experienced shivers, fatigue, injection site swelling, injection site pain and injection site warmth. On an unknown date, the outcome of the shivers, fatigue, injection site swelling, injection site pain and injection site warmth were unknown.   It was unknown if the reporter considered the shivers, fatigue, injection site swelling, injection site pain and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not provided. The patient had swelling on the injection site for 2 days and asked about how can the swelling and pain go away. The patient also had fatigue and did not have shivers the first night. The patient asked if she could put ice pack at the injection site. The patient feels injection site warm to touch.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site paraesthesia, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: Sore arm; fever; tiredness; swelling arm; tingling face; injection site tingling; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date 3 months ago, refer case US2019109637) and Shingles vacccine. Concurrent medical conditions included neurological disorder nos, back disorder and allergy nos (49 different things).   On 12th June 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In June 2019, less than a week after receiving Shingrix, the patient experienced pain in arm, fever, tiredness, swelling arm, tingling and injection site tingling. The patient was treated with acetylsalicylic acid (Aspirin) and paracetamol (Acetaminophen). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, fever, tiredness, swelling arm, tingling and injection site tingling were unknown.   It was unknown if the reporter considered the pain in arm, fever, tiredness, swelling arm, tingling and injection site tingling to be related to Shingrix.  Additional details were provided as follows: The patient had been receiving allergy and serum shots as he was allergic to 49 different things. He also had the original Shingles shot in the past.  The patient received the 2nd dose of Shingrix vaccine in the left arm.  The patient experienced sore arm, fever, tiredness, swelling of the arm, tingling of face and injection site. He had taken aspirin. He called and spoke to his nurse and he was advised to take acetaminophen. The fever goes and comes back.  The reporter had consented to follow up. No further details were provided.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Sore arm; fever; tiredness; swelling arm; tingling face; injection site tingling; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on an unknown date 3 months ago, refer case US2019109637) and Shingles vacccine. Concurrent medical conditions included neurological disorder nos, back disorder and allergy nos (49 different things).   On 12th June 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In June 2019, less than a week after receiving Shingrix, the patient experienced pain in arm, fever, tiredness, swelling arm, tingling and injection site tingling. The patient was treated with acetylsalicylic acid (Aspirin) and paracetamol (Acetaminophen). Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm, fever, tiredness, swelling arm, tingling and injection site tingling were unknown.   It was unknown if the reporter considered the pain in arm, fever, tiredness, swelling arm, tingling and injection site tingling to be related to Shingrix.  Additional details were provided as follows: The patient had been receiving allergy and serum shots as he was allergic to 49 different things. He also had the original Shingles shot in the past.  The patient received the 2nd dose of Shingrix vaccine in the left arm.  The patient experienced sore arm, fever, tiredness, swelling of the arm, tingling of face and injection site. He had taken aspirin. He called and spoke to his nurse and he was advised to take acetaminophen. The fever goes and comes back.  The reporter had consented to follow up. No further details were provided.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Nausea, Pyrexia, Vomiting
Clinical narrative: in first 24 hours of administration of vaccines pt has developed nausea/vomiting/bodyache a fever of 101 degree F. Zofran was prescribed for nausea/vomiting along with hydration.
Age: 1.42
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Breath holding, Irritability, Seizure
Clinical narrative: Mother of child states that pt. has anoxic seizures and is under the care of a neurologist. Has had vaccinations in the past with no triggered seizures. Neurologist has advised that vaccination is still recommended. Mother of child knows actions to take if seizure occurs. Vaccinations given, after vaccination child held breath and experienced a 1.5 minuet seizure. Mother of child stated that the seizure was typical of others in the past. No injury occurred, mother held child throughout the duration of seizure and during recovery. Offered oxygen and to call 911 but mother declined. Child recovered from seizure with no injury but was irritable. Mother consouled child and sat in clinic for 30 minuets to recover. Advised mother to call neurologist and update on the occurance of seizure after vaccination and if any further seizures occur.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Musculoskeletal pain, Musculoskeletal stiffness, Myalgia
Clinical narrative: Continual stiff neck, soreness of neck, shoulder and upper back.  Soreness in major joints and muscular areas, such as arms and legs.
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Neck pain
Clinical narrative: Continual stiff neck, soreness of neck, shoulder and upper back.  Soreness in major joints and muscular areas, such as arms and legs.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site rash, Injection site reaction
Clinical narrative: Patient came in with what appeared to be a reaction at the injection site. Her arm had a large round raised rash. It was not directly over the injection site, it was located down her arm several inches. She said it was very painful, but did not itch.  She was going to have her doctor take a look.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Injection site erythema, Injection site swelling, Myalgia
Clinical narrative: Redness and swelling at injection site. Shivering, muscle aches and dizziness.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Redness, induration and pain at injection site.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Ear pruritus, Injection site erythema, Injection site pruritus
Clinical narrative: Patient describes having redness at the injection site and surrounding area, not greater than the size of a quarter. She is itchy on the injected arm above the elbow. Her ears are itchy, more on the left than the right ear. No other symptoms were reported.