chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown 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 information was provided as follows: The age at vaccination was not reported. The patient developed shingles following 1st dose of Shingrix vaccine. The reporter consented to follow up. No additional information was avaialble from registered pharmacist at the time of reporting. This case is linked with US2020024269, reported by same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Peripheral swelling, Product supply issue, Pyrexia
Clinical narrative: couldn't get the second dose due to the GSK shortage.; light fever; swollen left arm; This case was reported by a consumer via call center representative and described the occurrence of fever in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in June 2018).   In August 2019, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, between 5 and 7 months after receiving Shingrix, the patient experienced fever, swelling arm and product supply issue. On an unknown date, the outcome of the fever and swelling arm were recovered/resolved and the outcome of the product supply issue was unknown.   It was unknown if the reporter considered the fever and swelling arm to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The patient couldn't get the second dose due to the GSK shortage.  The patient had a well visit at her physician's office and they referred her to an independent pharmacy who had the vaccine in stock.   The pharmacist informed her that because she missed the 2 to 6 month window for the second dose, she would need to restart the vaccine series.   She received both shots in her left arm intramuscularly.  The patient also reported a light fever and swollen left arm for three days after the vaccinations and the swelling resolved with ice. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever or 104F; This case was reported by a physician via call center representative and described the occurrence of fever in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fever. On an unknown date, the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the fever to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced fever of 104 fahrenheit after the first dose of Shingrix that lasted 24 hours. The reporter did not consent to folllow up.      Lab Comments: On an unknown date, the lab test was performed.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives; This case was reported by a physician via call center representative and described the occurrence of hives in a adult patient who received Herpes zoster (Shingrix) (batch number 4257F, expiry date 11th September 2021) for prophylaxis.   On 30th August 2019, the patient received Shingrix. In August 2019, less than a day after receiving Shingrix, the patient experienced hives. In September 2019, the outcome of the hives was recovered/resolved.   It was unknown if the reporter considered the hives 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 was seen in August 2019 was administered the Shingrix vaccination and patient complained of reaction within 24 hours of administration. The patient had of raised Hives, was symptomatic for 3 days. The reporter consented for follow up. This case was linked with US2020026081, reported by same reporter.
Age: 57.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Second dose of Shingrix in Nov 2019 and in Jan 2020 she developed outbreak of shingles; Outbreak of shingles; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (3 times prior to vaccination).   On an unknown date, the patient received the 1st dose of Shingrix. In November 2019, the patient received the 2nd dose of Shingrix (intramuscular). In January 2020, unknown after receiving Shingrix and between 2 and 3 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received Shingrix in Nov 2019 and in Jan 2020 she developed outbreak of shingles. The reporter did not consent to follow up. This case was considered as suspected vaccination failure, since the details regarding laboratory confirmation for shingles were not provided.
Age: 7.0
Sex: F
Vaccine: UNK
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Influenza like illness, Myalgia, Pyrexia
Clinical narrative: As was true of the first dose I received, I had chills, upset stomach, muscle aches.  Feels like having the flu or a fever.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: As was true of the first dose I received, I had chills, upset stomach, muscle aches.  Feels like having the flu or a fever.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: PATIENT DEVELOPED A RASH ON STOMACH & BACK, NOT ITCHY, BUT A LITTLE RAISED. PATIENT FELT ACHY, CHILLS.  INJECTION SITE WAS RED, PUFFY, AND WARM.  RASH ON RIGHT ARM DEVELOPED BUT PATIENT RECEIVED VACCINE IN LEFT ARM.  ALL SYMPTOMS WERE RESOLVED BY TUESDAY THE FOLLOWING WEEK.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash papular
Clinical narrative: PATIENT DEVELOPED A RASH ON STOMACH & BACK, NOT ITCHY, BUT A LITTLE RAISED. PATIENT FELT ACHY, CHILLS.  INJECTION SITE WAS RED, PUFFY, AND WARM.  RASH ON RIGHT ARM DEVELOPED BUT PATIENT RECEIVED VACCINE IN LEFT ARM.  ALL SYMPTOMS WERE RESOLVED BY TUESDAY THE FOLLOWING WEEK.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Dyspnoea, Fatigue, Haematuria, Injection site rash, Pruritus
Clinical narrative: HAD MEN B AND FLU VACCINES AT ABOUT 2:30 PM. WENT TO BASKETBALL PRACTICE. FELT ITCHY OF TORSO/ARMS/LEGS, SHORT OF BREATH, SHAKY, FATIGUE, SCRATCHY THROAT (RESOLVED AFTER TAKING BENADRYL), RASH AT SITE OF MEN B INJECTION, HEMATURIA. SEEN IN ER FOR SYMPTOMS. TREATED WITH CIPRO.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Throat irritation, Tremor
Clinical narrative: HAD MEN B AND FLU VACCINES AT ABOUT 2:30 PM. WENT TO BASKETBALL PRACTICE. FELT ITCHY OF TORSO/ARMS/LEGS, SHORT OF BREATH, SHAKY, FATIGUE, SCRATCHY THROAT (RESOLVED AFTER TAKING BENADRYL), RASH AT SITE OF MEN B INJECTION, HEMATURIA. SEEN IN ER FOR SYMPTOMS. TREATED WITH CIPRO.
Age: 34.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Injection site joint pain
Clinical narrative: Tdap on 2/4 and developed unilateral L sided joint pain of shoulder, elbow, and knee that resolved after 24-48 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: 12 hours after vaccine given at 5:00 a.m. woke tobeing  Dizzy, Nausea with vomiting,  and headache; dizzy, headache and nausea continued all day, vomiting again three times between 7:00 p.m. and  7:30 p.m. with slight fever:  dizzy and headache continued for the next week; started to disappear but  I still have periods of dizziness and it has now been three weeks.
Age: 12.0
Sex: F
Vaccine: HPV9
Symptoms: Arthralgia, Dizziness, Muscular weakness, Pain in extremity
Clinical narrative: Day after vaccine, patient was dizzy and had arm weakness. She had 3 days for dizziness, and AM was worse.  She also had pain in her L leg and knee.  She no strength in her left hand for a day.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Shortly after he received the vaccine (an hour or two afterwards), his left deltoid became very swollen and red.  It was warm to the touch and very painful.  The swelling persisted that night.  It did not start going down until the following day.  As of 2/18/19, his arm is no longer swollen but it is still very painful and he describes it as feeling like a deep bruise.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 47.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 74.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Sex: F
Vaccine: PNC13, UNK, UNK
Symptoms: Dyspnoea, Pyrexia
Clinical narrative: Fever / 102.7; Breathing difficult; This is a spontaneous report based on the information received by Pfizer (Manufacturer Report Number: USA 20191207961) from a non-contactable physician and a consumer.  This case was regarding a patient who received Otezla therapy for the treatment of psoriatic arthritis mutilans, psoriatic arthropathy and psoriasis vulgaris. Co-suspect medication Prevnar was included. On an unspecified date, Patient experienced the events 102.7 fever, trouble breathing while taking Otezla therapy. Physician stated that patient had no allergic reaction to Otezla. Outcome of the events 102.7 fever, trouble breathing was not recovered/not resolved. The causal relationship between the Otezla and the events 102. 7 fever, trouble breathing was not related. This case is linked to # (Pruritus) and # (Multiple fractures, Fall, Rib fracture). Initial information was received on 18Dec2019 via Otezla Support Program from a patient. Additional information was received on 27Jan2020 from physician in response to queries. Updated information was added. Co suspect medication, Clinical course information. Updated information was identified between double carets.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Limb discomfort, Mobility decreased, Pain in extremity, Vaccination complication
Clinical narrative: Severe pain in her arm; She can rub her muscles and massage her arm but she cannot move her arm. She can't move it behind her, and she can't move it up; This is a spontaneous report from a contactable consumer (patient). A 68-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13), via an unspecified route of administration, received at the pharmacy on 21Jan2020 at a single dose to prevent pneumonia. There were no medical history and concomitant medications. The patient reported that she had a bad reaction to the pneumonia shot. She only took it one time, and she still had the severe pain in her arm. She went to the doctor, and to the emergency room, they did not know anything. She can rub her muscles and massage her arm but she cannot move her arm. She can't move it behind her, and she can't move it up. It's like something is eating her flesh. She is wondering how long it is going to take for her arm to get well. Events occurred on 21Jan2020. Outcome of the events was not recovered.  Information on the batch/lot number has been requested.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Pain, Rheumatoid arthritis, Swelling, Tenderness
Clinical narrative: moderate pain; tenderness; severe erythema; swelling; This is a Spontaneous report from a contactable Physician. A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on 29Jul2019 (on day 57) at single dose for immunisation. The patient's medical history and concomitant medications were not reported. The patient previously took meningococcal group b rlp2086 for immunization on day 4, after being vaccinated no noted adverse reaction noted. On day 57 after being vaccinated on the left upper arm, subject reported at 17:00 same day, moderate pain, tenderness, severe erythema and swelling measured (12.5x 16 cm).  However, the patient wass able to perform daily activities. She denied any fever or systemic signs. Took Ibuprofen as needed. Resolution of the events was on 02Aug2019 at 09:29. The patient had rheumatoid arthritis from 24Oct2019 to an unknown date.  No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: mild swelling, erythema and pain in area of injection; mild swelling, erythema and pain in area of injection; mild swelling, erythema and pain in area of injection; This is a spontaneous report from a contactable physician. A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration on 24Oct2019 at single dose for immunization. Medical history included rheumatoid arthritis (RA) from an unknown date and unknown if ongoing. The patient's concomitant medications were not reported. The patient experienced mild swelling, erythema and pain in area of injection on 26Oct2019 at 03:37. She denied any fever or systemic signs. She took Ibuprofen as needed for treatment. The outcome of the events was resolved on 01Nov2019 at 09:00.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: some mild swelling , erythema no pain in area of injection; some mild swelling , erythema no pain in area of injection; This is a spontaneous report from a contactable physician.   A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration at single dose on 17Dec2019 10:42 for immunisation.  Medical history included rheumatoid arthritis. Concomitant medications were not reported. The patient previously took meningococcal group b rlp2086 for immunisation on 24Oct2019 and experienced mild swelling, erythema and pain in area of injection.  On 18Dec2019 15:00, the patient experienced some mild swelling , erythema no pain in area of injection. She denied any fever or systemic signs. No medication taken. The outcome of the events was recovered on 22Dec2019 at 08:00.  No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: F
Vaccine: MENB
Symptoms: Erythema, Impaired work ability, Pain, Pain in extremity, Peripheral swelling
Clinical narrative: moderate pain; tenderness; erythema; swelling measuring 10.0 cm; unable to go to work secondary to pain in her arm; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in the left upper arm on 30Jan2020 at a single dose for immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced moderate pain, tenderness, erythema, swelling measuring 10.0 cm and was unable to go to work secondary to pain in her arm on 30Jan2020. She denied any fever or systemic signs.  Therapeutic measures were taken as a result of the events and included: Ibuprofen and ice pack as needed.  The outcome of the events was recovered on 04Feb2020.    No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Sex: F
Vaccine: MENB
Symptoms: Swelling, Tenderness
Clinical narrative: moderate pain; tenderness; erythema; swelling measuring 10.0 cm; unable to go to work secondary to pain in her arm; This is a spontaneous report from a contactable consumer.  A female patient of an unspecified age received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration in the left upper arm on 30Jan2020 at a single dose for immunization.  The patient's medical history and concomitant medications were not reported.  The patient experienced moderate pain, tenderness, erythema, swelling measuring 10.0 cm and was unable to go to work secondary to pain in her arm on 30Jan2020. She denied any fever or systemic signs.  Therapeutic measures were taken as a result of the events and included: Ibuprofen and ice pack as needed.  The outcome of the events was recovered on 04Feb2020.    No follow-up attempts are possible; information about batch/lot number cannot be obtained.
Sex: U
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Severe hives; This is a spontaneous report from a contactable Physician.  A patient of unspecified age and gender received pneumococcal 13-val conjugate vaccine (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration on 2016 at single dose for immunisation.  The patient medical history and concomitant medications were not reported.  The patient experienced severe hives (non-serious) on an unspecified date with outcome of unknown.    Information on lot batch number has been requested.
Sex: F
Vaccine: PPV
Symptoms: Pneumonia
Clinical narrative: Pneumonia; Pneumonia; This is a spontaneous report from a Pfizer sponsored program. A contactable consumer (patient) reported that a female patient of an unspecified age (73 unknown unit) received pneumococcal 13-val conj vac (dipht crm197 protein), via an unspecified route of administration in Oct2019 at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient indicated that she did not engage a doctor, health care professional or pharmacist to get vaccinated in the past 3 months, since she was vaccinated while hospitalized in Oct2019 for 2 types of pneumonia. Although she suffered pneumonia despite being vaccinated, vaccines were not 100% effective, and there were still other 'bugs' out there, and harassment from people that she's stupid to keep getting vaccines because she still got the disease did not discourage her. The outcome of events was unknown.   Pfizer is a marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) in the country of incidence or the country where the product was purchased (if different). This may be a duplicate report if another marketing authorization holder of Pneumococcal 13-Val Conj Vac (Dipht CRM197 Protein) has submitted the same report to the regulatory authorities.  Information on the Lot/batch number has been requested.
Age: 20.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: Experienced a fever; Severe redness and swelling of her upper arm; Severe redness and swelling of her upper arm; This is a spontaneous report from contactable physician via Pfizer sales representative.  A female patient in her 20s received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) , on an unspecified date at single dose for immunisation. Medical history included asthma. The patient's concomitant medications were not reported.  On an unknown date the patient experienced fever and severe redness and swelling of her upper arm, that lasted for a few days after vaccination. The outcome of the events was recovered on an unknown date.Information on the batch number has been requested
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillain-Barre syndrome; This is a spontaneous case, initially received from other health professional (nurse), via Merck, to Agency (reference number: SEQ20-00612) on 12-Feb-2020, concerning a male patient of unspecified age. At the time of this report the patient was 66-year-old.  The patient did not have any medical history.  The patient's historical medications included unspecified influenza vaccine and unspecified sulfa drug due to which the patient experienced unspecified adverse events. The patient's concomitant medications were not provided.  On an unspecified date in 2018, the patient was administered unspecified seasonal flu vaccine [influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number and expiration date: not reported] for an unknown indication.   On an unspecified date in 2018, at unknown amount of time after vaccination, the patient experienced Guillain-Barre syndrome. It was reported that the patient did not receive any corrective treatment for the event.  At the time of this report, the outcome of the event was not reported.  Per company, the event of Guillain-Barre syndrome was considered as serious due to criterion of medical significance.  The reporter did not provide causality assessment to unspecified seasonal flu vaccine.  The case is linked to the case 202001703 due to the same reporter.  Company comment: The patient experienced Guillain-Barre syndrome after vaccination with the suspect product, unspecified flu vaccine. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided.  Considering all the above mentioned, causality between suspect product and the event is assessed as related.; Sender's Comments: The patient experienced Guillain-Barre syndrome after vaccination with the suspect product, unspecified flu vaccine. Chronology is plausible. No medical history, concomitant medications and diagnostic findings were provided.  Considering all the above mentioned, causality between suspect product and the event is assessed as related.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Musculoskeletal pain, Neck pain, X-ray
Clinical narrative: The following Friday, the signs and symptoms started. It started with pain on the neck on the left side, shoulder, and the left arm where the vaccine was administered.  An X-ray and physical therapy was done.  Voltaren and Norflex
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: Wrong dose given for childs age. Received 0.25mL should have been given 0.50mL. Per health department dose must be repeated with correct vaccine dose. No adverse reaction
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 21.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 60.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 4.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 24.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Feeling abnormal, Influenza like illness, Injection site pain, Muscle twitching
Clinical narrative: Clt. states flu like symptoms for 2 weeks, soreness at HPV injection site for 2 weeks, frequent twitching of right hand and the feeling that he had just had a cast removed from forearm for 3 weeks.  Symptoms resolved.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain
Clinical narrative: Patient was calling to inform her got extremely sore and hard to move but not until 10 days after vaccination.  She was unsure if it was related but wanted to report it could be a possible reaction.
Age: 3.0
Sex: F
Vaccine: DTAPIPV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Provider ordered Dtap, nurse gave Kinrix. Patient's mother was called with med error. Patient not having any adverse reactions at this time.
Sex: U
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: Upper right arm redness; This is a spontaneous report from a contactable physician. A patient of an unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA, lot 17-003292, exp.date 31Jan2019), via an unspecified route of administration on the right upper arm on unknown date at 0.5ml single dose for immunization. Medical history and the patient's concomitant medications were not reported. The patient experienced upper right arm redness on 11Jan2019. The patient recovered from the event on 13Jan2019.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: MENB
Symptoms: Erythema, Induration
Clinical narrative: Upper right arm erythema and induration (1.5in x 2in); Upper right arm erythema and induration (1.5in x 2in); This is a spontaneous report from a contactable physician. This physician reported non serious events. A patient of unspecified age and gender received meningococcal group b rlp2086 (TRUMENBA), via an unspecified route of administration, on an unspecified date, at 0.5 ml single, for immunisation. The patient's medical history and concomitant medications were not reported. The patient experienced upper right arm erythema and induration (1.5in x 2in) on an unspecified date with outcome of unknown.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site reaction, Rash macular
Clinical narrative: Red Blotchy patches on injection site. Less likely cellulitis.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 94.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 7.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 6.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 3.0
Sex: F
Vaccine: DTAP
Symptoms: Eczema
Clinical narrative: Eczema on top of both hands.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Gaze palsy, Injection site pain, Myalgia, Nausea, Pyrexia
Clinical narrative: soreness at injection site, muscle pain throughout body, fever, headache, queeziness
Age: 10.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 0.5
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: erythematous patch that is 8x8cm in largest diameter with smaller areas of extension of the erythema beyond the main rash on right thigh where PCV was injected.  Rash began approximately 15 min after vaccine administration, while she was still in the exam room.
Age: 9.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 12.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 6.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 12.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 8.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 41.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Asthenia, Asthma, Blood test, Bursitis, Condition aggravated
Clinical narrative: Influenza vaccine - manufacturer/lot number unknown 11/06 8:45 a.m. (appointment time) staff administered flu shot 11/06, early evening:  Extreme pain that lasted for 3 nights/days.  When I reported this the following week when I was called by staff with blood work results, I was told that this year's shot hurt more than usual.   Pain continued for 5 weeks, both at rest and especially during some movements as well as weakness/inability to function properly.  Unable to lift a gallon of milk or get dressed or undressed properly.  12/12 When I brought it up when I was called again with blood work results, the nurse took it seriously and scheduled me an appointment for the following Monday 12/16  My primary evaluated me and concluded that a tendon was probably hit with the flu shot based on where it was hurting.  She prescribed me oral steroids and physical therapy.  Also had x-ray done which came back with no issues.  Then I got a call a couple of weeks later to check on my arm/shoulder and was asked to hold off on physical therapy because steroids might be enough.  12/22 I came down with a sickness and was given stronger steroids to calm down my asthma, which masked my arm/shoulder pain longer 01/12 - arm / shoulder pain returned so I proceeded with physical therapy  02/17 - saw orthopedic dr who diagnosed me with impingement syndrome of left shoulder and bursitis of left shoulder
Age: 41.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Loss of personal independence in daily activities, Malaise, Musculoskeletal pain, Pain, Pain in extremity
Clinical narrative: Influenza vaccine - manufacturer/lot number unknown 11/06 8:45 a.m. (appointment time) staff administered flu shot 11/06, early evening:  Extreme pain that lasted for 3 nights/days.  When I reported this the following week when I was called by staff with blood work results, I was told that this year's shot hurt more than usual.   Pain continued for 5 weeks, both at rest and especially during some movements as well as weakness/inability to function properly.  Unable to lift a gallon of milk or get dressed or undressed properly.  12/12 When I brought it up when I was called again with blood work results, the nurse took it seriously and scheduled me an appointment for the following Monday 12/16  My primary evaluated me and concluded that a tendon was probably hit with the flu shot based on where it was hurting.  She prescribed me oral steroids and physical therapy.  Also had x-ray done which came back with no issues.  Then I got a call a couple of weeks later to check on my arm/shoulder and was asked to hold off on physical therapy because steroids might be enough.  12/22 I came down with a sickness and was given stronger steroids to calm down my asthma, which masked my arm/shoulder pain longer 01/12 - arm / shoulder pain returned so I proceeded with physical therapy  02/17 - saw orthopedic dr who diagnosed me with impingement syndrome of left shoulder and bursitis of left shoulder
Age: 41.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Rotator cuff syndrome, Tendon injury, X-ray normal
Clinical narrative: Influenza vaccine - manufacturer/lot number unknown 11/06 8:45 a.m. (appointment time) staff administered flu shot 11/06, early evening:  Extreme pain that lasted for 3 nights/days.  When I reported this the following week when I was called by staff with blood work results, I was told that this year's shot hurt more than usual.   Pain continued for 5 weeks, both at rest and especially during some movements as well as weakness/inability to function properly.  Unable to lift a gallon of milk or get dressed or undressed properly.  12/12 When I brought it up when I was called again with blood work results, the nurse took it seriously and scheduled me an appointment for the following Monday 12/16  My primary evaluated me and concluded that a tendon was probably hit with the flu shot based on where it was hurting.  She prescribed me oral steroids and physical therapy.  Also had x-ray done which came back with no issues.  Then I got a call a couple of weeks later to check on my arm/shoulder and was asked to hold off on physical therapy because steroids might be enough.  12/22 I came down with a sickness and was given stronger steroids to calm down my asthma, which masked my arm/shoulder pain longer 01/12 - arm / shoulder pain returned so I proceeded with physical therapy  02/17 - saw orthopedic dr who diagnosed me with impingement syndrome of left shoulder and bursitis of left shoulder
Age: 41.0
Sex: F
Vaccine: UNK, FLU4
Symptoms: Bursitis, Injection site pain, Musculoskeletal pain, Product administered at inappropriate site, Rotator cuff syndrome
Clinical narrative: Influenza vaccine - manufacturer/lot number unknown 11/06 8:45 a.m. (appointment time) staff administered flu shot 11/06, early evening:  Extreme pain that lasted for 3 nights/days.  When I reported this the following week when I was called by staff with blood work results, I was told that this year's shot hurt more than usual.   Pain continued for 5 weeks, both at rest and especially during some movements as well as weakness/inability to function properly.  Unable to lift a gallon of milk or get dressed or undressed properly.  12/12 When I brought it up when I was called again with blood work results, the nurse took it seriously and scheduled me an appointment for the following Monday 12/16  My primary evaluated me and concluded that a tendon was probably hit with the flu shot based on where it was hurting.  She prescribed me oral steroids and physical therapy.  Also had x-ray done which came back with no issues.  Then I got a call a couple of weeks later to check on my arm/shoulder and was asked to hold off on physical therapy because steroids might be enough.  12/22 I came down with a sickness and was given stronger steroids to calm down my asthma, which masked my arm/shoulder pain longer 01/12 - arm / shoulder pain returned so I proceeded with physical therapy  02/17 - saw orthopedic dr who diagnosed me with impingement syndrome of left shoulder and bursitis of left shoulder
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H.
Age: 13.0
Sex: M
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 80.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Constipation, Herpes zoster
Clinical narrative: Patient was constipated which was out of norm.  On 2/12, patient went to dermatologist for annual check-up and had no skin issues. Patient went to doctor on 2/14 and given MiraLax; symptoms resolved.  Shingles symptoms started 2/13 or 2/14; patient noticed the shingles blisters on Saturday. Patient checked-in with pharmacist on 2/16 and was encouraged to follow-up with clinician.  Patient went to doctor on 2/17 and verified patient had full-blown case of shingles. Doctor prescribed Valacyclovir HCL 1 gram (3xday) and 800mg of Ibuprofen.  Patient has not used Ibuprofen yet..  Medicine is not working fast enough.Patient had shingles outbreak in 2004.  Patient received the Zostavax vaccine 2 years later with no problem It is not working fast enough.
Age: 13.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 1.25
Sex: M
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Injection site reaction, Rash macular, Rash pruritic
Clinical narrative: Itchy macular rash developed on posterior part of leg and buttocks starting 3 days ago worsening over the last few days.
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 10.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Child received MMR + dTap immunizations; one in each arm. Not sure what was given in what arm. However, child presented with a mild fever the next day. The area of the injection on the left arm was of a welt, about 2.5 inches in diameter: raised and red, hot to touch. Child did not complain of pain or discomfort and was otherwise in good spirits.  I called the her physician and reported the reaction and have followed the physician's instructions.
Age: 4.0
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Child received MMR + dTap immunizations; one in each arm. Not sure what was given in what arm. However, child presented with a mild fever the next day. The area of the injection on the left arm was of a welt, about 2.5 inches in diameter: raised and red, hot to touch. Child did not complain of pain or discomfort and was otherwise in good spirits.  I called the her physician and reported the reaction and have followed the physician's instructions.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 27.0
Sex: F
Vaccine: HEP
Symptoms: Cough, Dyspnoea, Oropharyngeal pain, Respiratory tract congestion
Clinical narrative: Cough, sore throat, congestion, shortness of breath. No treatment.
Age: 1.25
Sex: M
Vaccine: VARCEL
Symptoms: Pyrexia, Rash pustular, Varicella post vaccine
Clinical narrative: My son got varicella to his groin, buttocks and legs about two weeks after inoculation. He started running fevers and then erupted into pustules on 2/17/20.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient perceived reaction at injection site, area appeared red, slightly swollen and warm to touch , area approximately 1 in by 2 in in size.  Suggested OTC pain relief and ice to area. Appears to be normal reaction to IM injection not requiring medical attention
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Immediate post-injection reaction, Loss of consciousness
Clinical narrative: pt passout just after giving the vaccine
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Decreased appetite, Injection site bruising, Injection site pain, Injection site swelling, Loss of personal independence in daily activities
Clinical narrative: Pain, swelling, bruising at injection site, fever , no appetite, feeling very sick, sent home from school by nurse  the following day Jan 7, 2020.  Pain and Swollen arm still present above injection site day 4. Swelling, pain present for 7 days.  7 days purple bruising at injection site.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Pyrexia
Clinical narrative: Pain, swelling, bruising at injection site, fever , no appetite, feeling very sick, sent home from school by nurse  the following day Jan 7, 2020.  Pain and Swollen arm still present above injection site day 4. Swelling, pain present for 7 days.  7 days purple bruising at injection site.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: Patient was  given an expired injection. Daptacel injection given expired on 02/7/20 but was given on 02/18/20.
Age: 7.0
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: UNMONITORED TEMP FOR 63H
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Ear swelling, HIV antibody negative, Rash, Rash pruritic
Clinical narrative: About 4 hours after the vaccination, patient developed mildly itchy rash over chest and abdomen.  Received Benadryl that evening but hives progressed to involve left arm up to face and swelling of left ear.  Benadryl given around the clock.  Doctor visit today only minimal hives on left upper arm evident.  No shortness of breath, trouble swallowing, no wheezing.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Localized 6 inch square around injection site that was red, swollen warm and painful
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Pain, Pruritus
Clinical narrative: Right arm is red and hot below the area of her shingles vaccine she got 3 days prior.  It is also tender. MD recommended  trying Benadryl for a local reaction and if redness continues to spread or if she develops SOB, recommend they go to ER.  Patient ended up going to the ER 2 days later (2/10/2020) complaining of pain, itching, swelling and rash. ER workup was negative for any major concerns.  They gave her an Rx for Prednisone and Keflex to cover for possible early infection.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Swelling
Clinical narrative: Right arm is red and hot below the area of her shingles vaccine she got 3 days prior.  It is also tender. MD recommended  trying Benadryl for a local reaction and if redness continues to spread or if she develops SOB, recommend they go to ER.  Patient ended up going to the ER 2 days later (2/10/2020) complaining of pain, itching, swelling and rash. ER workup was negative for any major concerns.  They gave her an Rx for Prednisone and Keflex to cover for possible early infection.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Myalgia
Clinical narrative: 2 inch red, painful area on left arm at injection site which developed approximately 3 hours after injection; headache and muscle aches that started approximately 12 hours after injection
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Blood culture, Blood ethanol, Blood lactic acid, Blood magnesium, Brain natriuretic peptide
Clinical narrative: The affected individual called clinic two days after immunization to report concerns. Immunization was on 2-11-20, and she spoke with this nurse on 2-13-20. She reported to this RN on 2-13-20 that within a few hours of receiving the vaccine, she became severely dizzy, broke out in hives, had nausea and vomiting. Hives worsened over the next day to the point she reports she was covered in hives from head to toe. Localized swelling and redness at injection site.  She reports the area was red, not just pink. Nausea/vomiting continued for the next two days. RN directed her to go to ED. ED evaluation:
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Culture urine, Differential white blood cell count, Dizziness, Drug screen, Full blood count
Clinical narrative: The affected individual called clinic two days after immunization to report concerns. Immunization was on 2-11-20, and she spoke with this nurse on 2-13-20. She reported to this RN on 2-13-20 that within a few hours of receiving the vaccine, she became severely dizzy, broke out in hives, had nausea and vomiting. Hives worsened over the next day to the point she reports she was covered in hives from head to toe. Localized swelling and redness at injection site.  She reports the area was red, not just pink. Nausea/vomiting continued for the next two days. RN directed her to go to ED. ED evaluation:
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site erythema, Injection site swelling, Metabolic function test, Nausea, Troponin I
Clinical narrative: The affected individual called clinic two days after immunization to report concerns. Immunization was on 2-11-20, and she spoke with this nurse on 2-13-20. She reported to this RN on 2-13-20 that within a few hours of receiving the vaccine, she became severely dizzy, broke out in hives, had nausea and vomiting. Hives worsened over the next day to the point she reports she was covered in hives from head to toe. Localized swelling and redness at injection site.  She reports the area was red, not just pink. Nausea/vomiting continued for the next two days. RN directed her to go to ED. ED evaluation:
Age: 52.0
Sex: F
Vaccine: HEPA
Symptoms: Urine analysis, Urticaria, Vomiting
Clinical narrative: The affected individual called clinic two days after immunization to report concerns. Immunization was on 2-11-20, and she spoke with this nurse on 2-13-20. She reported to this RN on 2-13-20 that within a few hours of receiving the vaccine, she became severely dizzy, broke out in hives, had nausea and vomiting. Hives worsened over the next day to the point she reports she was covered in hives from head to toe. Localized swelling and redness at injection site.  She reports the area was red, not just pink. Nausea/vomiting continued for the next two days. RN directed her to go to ED. ED evaluation:
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Anxiety, Blood test, Chest X-ray, Computerised tomogram
Clinical narrative: Woke up 6 am went to the bathroom had dizziness, lightheadedness, anxiety, difficulty breathing,  stomach pain, sweating  and chilling, Nausea, and fainted.  Both hand were tingling and  fingers were closing unable to open. Called 911.  Fire and paramedics came took to hospital
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dyspnoea, Feeling cold, Hyperhidrosis, Muscle contractions involuntary
Clinical narrative: Woke up 6 am went to the bathroom had dizziness, lightheadedness, anxiety, difficulty breathing,  stomach pain, sweating  and chilling, Nausea, and fainted.  Both hand were tingling and  fingers were closing unable to open. Called 911.  Fire and paramedics came took to hospital
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Paraesthesia, Syncope
Clinical narrative: Woke up 6 am went to the bathroom had dizziness, lightheadedness, anxiety, difficulty breathing,  stomach pain, sweating  and chilling, Nausea, and fainted.  Both hand were tingling and  fingers were closing unable to open. Called 911.  Fire and paramedics came took to hospital