chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Asthenia, Balance disorder, Chills, Decreased appetite
Clinical narrative: Threw up; Stomach started hurting / Stomach cramps; Shivering; Loss of appetite; Nausea; Pain that went up the back of neck into the back of head; Slight headache / Pain that went up into the back of head; Off Balance; Felt weak; Shaky; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 72-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   Concurrent medical conditions included asthma and arthritis.   On 23rd October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). In October 2019, 3 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced balance disorder, weakness and tremor. On 23rd October 2019, the patient experienced neck pain and headache. On 4th November 2019, the patient experienced appetite lost and nausea. On an unknown date, the patient experienced vomiting, stomach pain and shivering. On an unknown date, the outcome of the neck pain, vomiting, balance disorder, weakness, tremor and shivering were recovered/resolved and the outcome of the headache was unknown and the outcome of the stomach pain, appetite lost and nausea were not recovered/not resolved.   It was unknown if the reporter considered the neck pain, headache, vomiting, stomach pain, balance disorder, weakness, tremor, appetite lost, nausea and shivering to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received dose of Flulaval vaccine in the left arm at around 10 am. Immediately after receiving the vaccine, the patient had pain that went up the back of her neck into the back of her head which lasted most of the day. Few days after vaccination, the patient had stomach pain and vomitting. Few days after this the patient threw up again and described that this time it was just clear liquid and mucus and again threw up on some unknown day last week from the date of reporting. The patient reported that, on the day of reporting, the stomach still hurts a little bit but not as bad. Three to four days after receiving the vaccine, the patient felt weak, shaky, and off balance. This symptoms occurred on and off a few times within a week of getting the vaccine. On the day of reporting, the patient stated that, now experiencing nausea, stomach cramps, and a loss of appetite and still had slight headache. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Nausea, Neck pain, Tremor, Vomiting
Clinical narrative: Threw up; Stomach started hurting / Stomach cramps; Shivering; Loss of appetite; Nausea; Pain that went up the back of neck into the back of head; Slight headache / Pain that went up into the back of head; Off Balance; Felt weak; Shaky; This case was reported by a consumer via call center representative and described the occurrence of neck pain in a 72-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   Concurrent medical conditions included asthma and arthritis.   On 23rd October 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular). In October 2019, 3 days after receiving FluLaval Tetra 2019-2020 season, the patient experienced balance disorder, weakness and tremor. On 23rd October 2019, the patient experienced neck pain and headache. On 4th November 2019, the patient experienced appetite lost and nausea. On an unknown date, the patient experienced vomiting, stomach pain and shivering. On an unknown date, the outcome of the neck pain, vomiting, balance disorder, weakness, tremor and shivering were recovered/resolved and the outcome of the headache was unknown and the outcome of the stomach pain, appetite lost and nausea were not recovered/not resolved.   It was unknown if the reporter considered the neck pain, headache, vomiting, stomach pain, balance disorder, weakness, tremor, appetite lost, nausea and shivering to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patient received dose of Flulaval vaccine in the left arm at around 10 am. Immediately after receiving the vaccine, the patient had pain that went up the back of her neck into the back of her head which lasted most of the day. Few days after vaccination, the patient had stomach pain and vomitting. Few days after this the patient threw up again and described that this time it was just clear liquid and mucus and again threw up on some unknown day last week from the date of reporting. The patient reported that, on the day of reporting, the stomach still hurts a little bit but not as bad. Three to four days after receiving the vaccine, the patient felt weak, shaky, and off balance. This symptoms occurred on and off a few times within a week of getting the vaccine. On the day of reporting, the patient stated that, now experiencing nausea, stomach cramps, and a loss of appetite and still had slight headache. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: rash; itching; warm to touch; Injection site raised; redness; This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 55-year-old female patient who received Herpes zoster (Shingrix) (batch number 3L3PR, expiry date 11th December 2021) for prophylaxis.   On 30th October 2019, the patient received the 1st dose of Shingrix (intramuscular). On 31st October 2019, 1 days after receiving Shingrix, the patient experienced injection site erythema. On 3rd November 2019, the patient experienced injection site rash and injection site itching. In November 2019, the patient experienced injection site warmth and injection site swelling. On an unknown date, the outcome of the injection site erythema, injection site warmth and injection site swelling were unknown and the outcome of the injection site rash and injection site itching were recovering/resolving.   It was unknown if the reporter considered the injection site erythema, injection site rash, injection site itching, injection site warmth and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The patient experienced some redness at the injection site and also developed an itchy rash at the injection site. The area was larger than the initial redness, raised and warm to the touch. The patient consented to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Extensive swelling of vaccinated limb, Incomplete course of vaccination, Rash, Vaccination complication
Clinical narrative: arm "blew up like a balloon"; "rash up and down arm"; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb and rash. On an unknown date, the outcome of the extensive swelling of vaccinated limb and rash were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb and rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and her arm blew up like a balloon and she had a rash up and down her arm that lasted a long time. The reporter stated that the patient was not going to get dose 2 of Shingrix due to a bad reaction to dose1.  The reporter did not consent to follow up. The reporter did not have any further details for this adverse event.
Sex: M
Vaccine: UNK
Symptoms: Loss of consciousness, Presyncope, Seizure, Syncope, Vomiting
Clinical narrative: seizure; vomiting; vagal response; fainted; unconscious; This case was reported by a consumer via call center representative and described the occurrence of fainting in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent 2019-2020 season at an unknown dose. On an unknown date, less than an hour after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced fainting (serious criteria GSK medically significant), unconscious (serious criteria GSK medically significant), seizure (serious criteria GSK medically significant), vagal reaction and vomiting. On an unknown date, the outcome of the fainting, unconscious and vagal reaction were recovered/resolved and the outcome of the seizure and vomiting were unknown.   It was unknown if the reporter considered the fainting, unconscious, seizure, vagal reaction and vomiting to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were provided as follows: The patient's father reported the case. The age at vaccination was not reported. The patient recently had a flu vaccine. Within 10 min after getting the dose, he had a vagal response. He fainted and was unconscious for 5 to 10 min. Then less than a day after vaccination, he started seizing and vomiting. The patient was taken to the emergency room. The reporter stated, the patient had similar experiences when he was young following injections or blood draws.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Disturbance in attention, Feeling abnormal, Influenza like illness, Mental impairment, Myalgia
Clinical narrative: trouble thinking; trouble concentrating/ forget how to play piano; felt that everything; Muscle pain; visual disturbances; flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty thinking in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th October 2019, less than a day after receiving Shingrix, the patient experienced muscle pain, visual disturbance and flu like symptoms. On 30th October 2019, the patient experienced difficulty thinking (serious criteria GSK medically significant), concentration impaired and feeling abnormal. On 1st November 2019, the outcome of the muscle pain, visual disturbance and flu like symptoms were recovered/resolved. On an unknown date, the outcome of the difficulty thinking, concentration impaired and feeling abnormal were recovering/resolving.   It was unknown if the reporter considered the difficulty thinking, muscle pain, visual disturbance, flu like symptoms, concentration impaired and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The reporter called on behalf of his mother.  The patient received the Shingrix in her left arm. On the same day, the patient developed muscle pain, flu like symptoms and visual disturbances. She took over the counter medications to treat these symptoms and these symptoms had resolved by that Saturday. The day after receiving the vaccine, patient had trouble thinking and concentrating. She felt that everything was moving slowly and she forgot how to play the piano. The patient's mental status started to improve on Saturday, however, she did not feel 100 percent back to normal till the time of reporting. The reporter did not consent to follow-up. This case has been linked to US2019203777, reported by the same reporter.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Visual impairment
Clinical narrative: trouble thinking; trouble concentrating/ forget how to play piano; felt that everything; Muscle pain; visual disturbances; flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of difficulty thinking in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 29th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th October 2019, less than a day after receiving Shingrix, the patient experienced muscle pain, visual disturbance and flu like symptoms. On 30th October 2019, the patient experienced difficulty thinking (serious criteria GSK medically significant), concentration impaired and feeling abnormal. On 1st November 2019, the outcome of the muscle pain, visual disturbance and flu like symptoms were recovered/resolved. On an unknown date, the outcome of the difficulty thinking, concentration impaired and feeling abnormal were recovering/resolving.   It was unknown if the reporter considered the difficulty thinking, muscle pain, visual disturbance, flu like symptoms, concentration impaired and feeling abnormal to be related to Shingrix.  Additional details were provided as follows: The reporter called on behalf of his mother.  The patient received the Shingrix in her left arm. On the same day, the patient developed muscle pain, flu like symptoms and visual disturbances. She took over the counter medications to treat these symptoms and these symptoms had resolved by that Saturday. The day after receiving the vaccine, patient had trouble thinking and concentrating. She felt that everything was moving slowly and she forgot how to play the piano. The patient's mental status started to improve on Saturday, however, she did not feel 100 percent back to normal till the time of reporting. The reporter did not consent to follow-up. This case has been linked to US2019203777, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal, Malaise
Clinical narrative: Sick; Felt horrible; This case was reported by a pharmacist via call center representative and described the occurrence of sickness 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 sickness and feels awful. On an unknown date, the outcome of the sickness and feels awful were unknown.   It was unknown if the reporter considered the sickness and feels awful to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and felt horrible and sick after the vaccination.The specific symptoms were unknown.  The reporter consented to follow up. The health care professional did not had the patient's initials, age, or exact date of vaccination as it was a random customer at the pharmacy from earlier in the day that mentioned the event. This case linked with US2019203796, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Multiple sclerosis relapse
Clinical narrative: Exacerbation of Multiple sclerosis; This case was reported by a nurse via call center representative and described the occurrence of multiple sclerosis exacerbation in a adult male patient who received Herpes zoster (Shingrix) (batch number 453LA, expiry date 8th August 2022) for prophylaxis.   Concurrent medical conditions included multiple sclerosis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced multiple sclerosis exacerbation (serious criteria GSK medically significant). On an unknown date, the outcome of the multiple sclerosis exacerbation was unknown.   It was unknown if the reporter considered the multiple sclerosis exacerbation to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter consented to follow up
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Insomnia, Musculoskeletal disorder, Pain
Clinical narrative: they did not put the Shingrix in the proper refrigerated storage conditions; blisters; Suspected Vaccination Failure; Shingles outbreak; Severe burning pain; Loss of sleep; Loss of function in an extremity; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 3rd July 2018, the patient received the 1st dose of Shingrix. On 11th September 2018, the patient received the 2nd dose of Shingrix. On 25th October 2019, 1 year and 114 days after receiving Shingrix and 1 year and 44 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain burning, sleep loss and upper extremity dysfunction. On 27th October 2019, the patient experienced blister. On an unknown date, the patient experienced incorrect storage of drug. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, shingles, pain burning, sleep loss, upper extremity dysfunction, blister and incorrect storage of drug were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain burning, sleep loss, upper extremity dysfunction and blister to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in the left deltoid. On 25th October 2019, the patient began experiencing shingles symptoms that progressed on the 27th October 2019 to blisters.  The patient reported stated she felt her shingles episode was severe with burning pain in the right arm and hand with a loss of function and sleep. The patient was under the treatment of a provider for the outbreak and has been prescribed Valtrex. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation for shingles were not provided. The patient also stated she overheard the pharmacist telling employees that they did not put the Shingrix in the proper refrigerated storage conditions.  The patient asked question about the viability of the vaccine she received. The reported consented to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product storage error, Vaccination failure
Clinical narrative: they did not put the Shingrix in the proper refrigerated storage conditions; blisters; Suspected Vaccination Failure; Shingles outbreak; Severe burning pain; Loss of sleep; Loss of function in an extremity; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 3rd July 2018, the patient received the 1st dose of Shingrix. On 11th September 2018, the patient received the 2nd dose of Shingrix. On 25th October 2019, 1 year and 114 days after receiving Shingrix and 1 year and 44 days after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles, pain burning, sleep loss and upper extremity dysfunction. On 27th October 2019, the patient experienced blister. On an unknown date, the patient experienced incorrect storage of drug. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the vaccination failure, shingles, pain burning, sleep loss, upper extremity dysfunction, blister and incorrect storage of drug were unknown.   It was unknown if the reporter considered the vaccination failure, shingles, pain burning, sleep loss, upper extremity dysfunction and blister to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient received 2nd dose of Shingrix in the left deltoid. On 25th October 2019, the patient began experiencing shingles symptoms that progressed on the 27th October 2019 to blisters.  The patient reported stated she felt her shingles episode was severe with burning pain in the right arm and hand with a loss of function and sleep. The patient was under the treatment of a provider for the outbreak and has been prescribed Valtrex. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation for shingles were not provided. The patient also stated she overheard the pharmacist telling employees that they did not put the Shingrix in the proper refrigerated storage conditions.  The patient asked question about the viability of the vaccine she received. The reported consented to follow up.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Chest pain, Electrocardiogram ambulatory, Headache, Vertigo
Clinical narrative: atrial fibrillation; chest pain; headache; vertigo; This case was reported by a consumer via call center representative and described the occurrence of atrial fibrillation in a 59-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 5th March 2019 and did not note any side effects).   On 25th June 2019, the patient received the 2nd dose of Shingrix. On 26th June 2019, 1 days after receiving Shingrix, the patient experienced headache and vertigo. On 5th July 2019, the patient experienced atrial fibrillation (serious criteria hospitalization and GSK medically significant) and chest pain (serious criteria hospitalization). On an unknown date, the outcome of the atrial fibrillation, chest pain, headache and vertigo were recovered/resolved.   It was unknown if the reporter considered the atrial fibrillation, chest pain, headache and vertigo to be related to Shingrix.  Additional details were provided as follows: The patient received dose 2 of Shingrix and the next day he experienced headache and vertigo, and events have resolved.   The patient reported that on 5th July 2019, he was experiencing chest pain.   The patient was admitted to the hospital and on 7th July 2019 a diagnosis of atrial fibrillation was made.   The patient was in the hospital for 2 nights and discharged.  He wore a heart monitor which was described as a wireless remote device for two weeks after discharge.  The monitor was read by the physician and there was nothing remarkable. The reporter consented to follow up. Emergency room visit required.
Sex: F
Vaccine: FLUX
Symptoms: Facial paralysis, Injection site bruising, Injection site swelling
Clinical narrative: part of her face fell, right side of face; injection site was swollen; injection site was bruise; Initial information received on 31-Oct-2019 regarding an unsolicited valid serious case received from a consumer.  This case involves female patient (age not reported) who experienced injection site was swollen (vaccination site swelling), injection site was bruise (vaccination site bruising) and part of her face fell, right side of face (facial paralysis), while she received vaccine INFLUENZA VACCINE.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE produced by unknown manufacturer lot number not reported via unknown route in the left arm.  On an unknown date, the patient developed a serious part of her face fell, right side of face (facial paralysis) (unknown latency) following the administration of INFLUENZA VACCINE. This was case serious due to important medical event- Facial paralysis.  On an unknown date, the patient developed a non-serious injection site was swollen (vaccination site swelling) and injection site was bruise (vaccination site bruising) (unknown latency) following the administration of INFLUENZA VACCINE.  Other relevant tests not reported.   Final diagnosis was vaccination site swelling, vaccination site bruising and facial paralysis.  It was not reported if the patient received a corrective treatment.  The outcome was unknown for vaccination site swelling, vaccination site bruising and facial paralysis.; Sender's Comments: This case concerns a female patient (age not reported) who experienced vaccination site swelling, vaccination site bruising and facial paralysis after vaccination with INFLUENZA VACCINE(unk mfr). The time to onset was unknown. However, patient's medical history, medical condition at time of vaccination and lab test ruling out alternate etiologies were not reported. Based upon the reported information, the role of the suspect vaccine cannot be assessed.
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Local reaction, Pain, Pruritus, Swelling
Clinical narrative: Patient woke up this morning with a local reaction to the arm which included swelling about the size of a half dollar, redness, itching, and soreness. Mom of patient gave her Loratidine and Acetaminophen.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arm of injection site swollen from  shoulder to wrist , red and warm  to  the touch as  well  as  painful  per  patient.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Arm of injection site swollen from  shoulder to wrist , red and warm  to  the touch as  well  as  painful  per  patient.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Disorientation, Feeling abnormal, Injection site hypoaesthesia, Lymphadenopathy, Mobility decreased
Clinical narrative: 11/05/2019  Right arm painful , hurt to move it.  The actual injection site felt numb. Slept very poorly, felt like she was in a twilight sleep ,  felt odd almost felt disoriented.  Woke up next morning 11/06/2019 with a stiff neck and pain , could hardly move neck and noticed lymph nodes on left side of upper chest and neck were swollen. This lasted about 24 hours.  11/12/2019 Starting to feel better, but continue to feel  sore and stiff.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Neck pain, Pain, Pain in extremity, Poor quality sleep
Clinical narrative: 11/05/2019  Right arm painful , hurt to move it.  The actual injection site felt numb. Slept very poorly, felt like she was in a twilight sleep ,  felt odd almost felt disoriented.  Woke up next morning 11/06/2019 with a stiff neck and pain , could hardly move neck and noticed lymph nodes on left side of upper chest and neck were swollen. This lasted about 24 hours.  11/12/2019 Starting to feel better, but continue to feel  sore and stiff.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pollakiuria, Syncope
Clinical narrative: right arm swollen and red from shoulder to elbow.  Pain in right upper arm.  Frequent urination.  Syncope x 1 on the evening of the injection.   Redness lasted for 3 days and gradually improved.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Headache, Pyrexia
Clinical narrative: chills, fever, headache, upset stomach overnight
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Eye swelling
Clinical narrative: Pt developed eye swelling of left eye the morning after she had the vaccine.  The swelling went down on its own by time of doctor's visit.  IT did not hurt or itch.  Eye was not injected.  No other symptoms.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Dizziness, Feeling hot, Immediate post-injection reaction, Injection site pain, Musculoskeletal pain
Clinical narrative: Pt got lightheaded first after standing up to put shirt on immediately after vaccine. 10-15 minutes later was having  tingliness  all over, pain in shoulders, and a warm sensation in his legs
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Pt got lightheaded first after standing up to put shirt on immediately after vaccine. 10-15 minutes later was having  tingliness  all over, pain in shoulders, and a warm sensation in his legs
Age: 67.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal discomfort, Chills, Headache, Palpitations, Pyrexia
Clinical narrative: Chills, Fever, Headache, Upset stomach, racing heartbeat
Age: 85.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Headache, Pyrexia, Rash
Clinical narrative: FEVER, FULL BODY RASH, WEAKNESS,  HEADACHE
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Rash, Rash erythematous, Respiratory tract congestion, Upper respiratory tract infection
Clinical narrative: Patient is a male 2 years who presents with hx rash at vaccine site. Had flu shot on Sunday 11/10. Mom noticed rash on Monday. No hx egg allergy. Not itching or bothering patient. Also had URI sxs starting Sunday into Monday. No fever. Mild cough and congestion. Sleeping and eating well. Otherwise well appearing. Scant rash on cheeks, no other rash on body. Rash is small pink bumps all over top of thigh. No redness or swelling noted. Cannot see injection site.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination site rash
Clinical narrative: Patient is a male 2 years who presents with hx rash at vaccine site. Had flu shot on Sunday 11/10. Mom noticed rash on Monday. No hx egg allergy. Not itching or bothering patient. Also had URI sxs starting Sunday into Monday. No fever. Mild cough and congestion. Sleeping and eating well. Otherwise well appearing. Scant rash on cheeks, no other rash on body. Rash is small pink bumps all over top of thigh. No redness or swelling noted. Cannot see injection site.
Age: 45.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Blood creatine phosphokinase, C-reactive protein, Chills, Cough, Fatigue
Clinical narrative: Patient presents to address malaise and fatigue.  She suspects these are vaccine reactions.  She received a flu vaccine in her right arm as well as a Pneumovax and TDap in her left arm on 11/1/19.  She states that she had left upper arm discomfort and soreness that evening.  The following morning she woke with increased left arm pain radiating up into her left shoulder and under the clavicle, pain with movement or palpation.  She states these areas feel warm and she has felt "terrible" with malaise, chills and sweats and feels feverish.  She notes a slight cough and nasal congestion though denies sore throat.  She did start Amoxicillin 11/1/19 for aom of the right ear and denies any continued ear pain.  She has naus
Age: 45.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Full blood count, Hyperhidrosis, Injection site discomfort, Injection site pain, Malaise
Clinical narrative: Patient presents to address malaise and fatigue.  She suspects these are vaccine reactions.  She received a flu vaccine in her right arm as well as a Pneumovax and TDap in her left arm on 11/1/19.  She states that she had left upper arm discomfort and soreness that evening.  The following morning she woke with increased left arm pain radiating up into her left shoulder and under the clavicle, pain with movement or palpation.  She states these areas feel warm and she has felt "terrible" with malaise, chills and sweats and feels feverish.  She notes a slight cough and nasal congestion though denies sore throat.  She did start Amoxicillin 11/1/19 for aom of the right ear and denies any continued ear pain.  She has naus
Age: 45.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Nasal congestion, Pain, Pyrexia, Red blood cell sedimentation rate, Skin warm
Clinical narrative: Patient presents to address malaise and fatigue.  She suspects these are vaccine reactions.  She received a flu vaccine in her right arm as well as a Pneumovax and TDap in her left arm on 11/1/19.  She states that she had left upper arm discomfort and soreness that evening.  The following morning she woke with increased left arm pain radiating up into her left shoulder and under the clavicle, pain with movement or palpation.  She states these areas feel warm and she has felt "terrible" with malaise, chills and sweats and feels feverish.  She notes a slight cough and nasal congestion though denies sore throat.  She did start Amoxicillin 11/1/19 for aom of the right ear and denies any continued ear pain.  She has naus
Age: 45.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Vaccination complication
Clinical narrative: Patient presents to address malaise and fatigue.  She suspects these are vaccine reactions.  She received a flu vaccine in her right arm as well as a Pneumovax and TDap in her left arm on 11/1/19.  She states that she had left upper arm discomfort and soreness that evening.  The following morning she woke with increased left arm pain radiating up into her left shoulder and under the clavicle, pain with movement or palpation.  She states these areas feel warm and she has felt "terrible" with malaise, chills and sweats and feels feverish.  She notes a slight cough and nasal congestion though denies sore throat.  She did start Amoxicillin 11/1/19 for aom of the right ear and denies any continued ear pain.  She has naus
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEP
Symptoms: Injection site erythema, Injection site swelling, Lethargy, Pyrexia
Clinical narrative: Child with fever>102,swelling and erythema to left leg at injection site and some lethargy.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Bone pain, Dizziness, Headache, Myalgia
Clinical narrative: Fever, dizziness, nausea, severs bone and muscle ache, headache, general weakness's
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Fever, dizziness, nausea, severs bone and muscle ache, headache, general weakness's
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Amenorrhoea, Antinuclear antibody negative, Blood prolactin normal, Blood thyroid stimulating hormone normal, Computerised tomogram normal
Clinical narrative: Patient notes since the vaccine she has had a persistent unrelenting headache for which she is continuing to undergo evaluation for. Additionally she notes persistent insomnia and two months of missed periods. Her major concern however is headache- CT and MRI thus far along with labs have been normal. Referring to neurology now for evaluation and consideration of LP tp r/o encephalitis
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Full blood count normal, Headache, Insomnia, Magnetic resonance imaging normal, Metabolic function test normal
Clinical narrative: Patient notes since the vaccine she has had a persistent unrelenting headache for which she is continuing to undergo evaluation for. Additionally she notes persistent insomnia and two months of missed periods. Her major concern however is headache- CT and MRI thus far along with labs have been normal. Referring to neurology now for evaluation and consideration of LP tp r/o encephalitis
Age: 45.0
Sex: F
Vaccine: MMR
Symptoms: Red blood cell sedimentation rate normal, Treponema test negative
Clinical narrative: Patient notes since the vaccine she has had a persistent unrelenting headache for which she is continuing to undergo evaluation for. Additionally she notes persistent insomnia and two months of missed periods. Her major concern however is headache- CT and MRI thus far along with labs have been normal. Referring to neurology now for evaluation and consideration of LP tp r/o encephalitis
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: There was no adverse event. The client was given the high dose influenza vaccine instead of the standard dose. Client was notified.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Conversion disorder, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: My son's thigh became swollen about six hours after, tripling in size.  It was bright red and hot to the touch. He was hysterical. We went to Urgent Care at Hospital and were told to give Benadryl and Motrin.  It took about 4 days to reduce swelling and return to normal.
Age: 36.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site discomfort, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: Patient noted a raised lump hours after initially receiving the vaccine. Patient states lump remained through work travel. Patient returned from the work travel in April 2019. Patient noted an enlargement of the lump and a redness starting in September. Mild itch and discomfort noted at location.
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: C-reactive protein normal, Full blood count normal, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Local swelling followed by pain and stiffness, initially affecting the right shoulder, then affecting entire torso
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Metabolic function test normal, Musculoskeletal stiffness, Pain, Red blood cell sedimentation rate normal, Swelling
Clinical narrative: Local swelling followed by pain and stiffness, initially affecting the right shoulder, then affecting entire torso
Age: 50.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Condition aggravated, Laboratory test, Muscle contracture
Clinical narrative: Local swelling followed by pain and stiffness, initially affecting the right shoulder, then affecting entire torso
Age: 29.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: 30-year old patient was administered a dose of DTaP instead of Tdap; no adverse reaction occurred; patient notified; verifying with Immunization Action Coalition what patient follow up is required. Contributing to the error are the following: 1. Nurse Practitioner (NP) giving vaccine; NP not as familiar with vaccines 2. Vaccine storage needs to be better organized and labeled; separating adult from pediatric and labeling
Age: 27.0
Sex: F
Vaccine: FLU4
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Patient experienced redness, swelling, and a very painful reaction to receiving the flu vaccine. Patient visited an urgent care, where reaction was diagnosed as cellulitis. Patient received antibiotics from urgent care on Thursday, 11/7. Reaction has since resolved with use of antibiotics.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient stated, she developed shoulder pain after getting flu vaccine
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Mass, Pruritus, Tenderness
Clinical narrative: Enlarged lymph node inferior to the lateral aspect of the left clavicle. Noted tenderness and mass the day following vaccination and growth in the size to ~.5-1cm 2 days following administration. Additionally reports associated itching.
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pruritus, Rash, Rash erythematous, Rash papular
Clinical narrative: RASH ALL OVER BODY, THAT SOUNDS LIKE PER PATIENT DESCRIPTION, RAISED RED SPOTS, DRAINING SOME FLUID. ITCHY AND PAINFUL WHEN SCRATCHED
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Secretion discharge
Clinical narrative: RASH ALL OVER BODY, THAT SOUNDS LIKE PER PATIENT DESCRIPTION, RAISED RED SPOTS, DRAINING SOME FLUID. ITCHY AND PAINFUL WHEN SCRATCHED
Age: 90.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash, Rash erythematous, Rash papular, Rash vesicular, Scratch
Clinical narrative: RASH ALL OVER BODY, THAT SOUNDS LIKE PER PATIENT DESCRIPTION, RAISED RED SPOTS, DRAINING SOME FLUID. ITCHY AND PAINFUL WHEN SCRATCHED
Age: 1.33
Sex: M
Vaccine: DTAP, FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site induration
Clinical narrative: Right lateral thigh 2x 4 cm of induration and 6x 8 cm of mild erythema , almost bruised looking. Prescribed Augmentin for treatment.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Arthralgia, Fatigue, Headache, Loss of personal independence in daily activities
Clinical narrative: Day  1 -Muscle spasms, muscle aching the worst across shoulders and up neck. Severe headache (lower back of head).  Severe muscle pain in arm that was injected. Including hyper sensitive to touch. Not the normal pain you experience from intramuscular injections. Upset stomach. Day 2 - previous symptoms plus, joint pain bilateral knees,  joint pain left ankle, shooting pain in left hip (nerve pain?) Felt like a stabbing, shooting pain from outside hip/upper thigh traveling inwards to mid/inner thigh. Fatigue. Day 3 - all of the same symptoms Day 4 - same symptoms but decreasing in intensity. Shooting hip/thigh pain reduced frequency. Extreme fatigue. Day 5 - symptoms continue to decrease. Day 6 - Can resume most normal activities with tolerable arm pain.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle spasms, Myalgia, Pain, Pain in extremity, Tenderness
Clinical narrative: Day  1 -Muscle spasms, muscle aching the worst across shoulders and up neck. Severe headache (lower back of head).  Severe muscle pain in arm that was injected. Including hyper sensitive to touch. Not the normal pain you experience from intramuscular injections. Upset stomach. Day 2 - previous symptoms plus, joint pain bilateral knees,  joint pain left ankle, shooting pain in left hip (nerve pain?) Felt like a stabbing, shooting pain from outside hip/upper thigh traveling inwards to mid/inner thigh. Fatigue. Day 3 - all of the same symptoms Day 4 - same symptoms but decreasing in intensity. Shooting hip/thigh pain reduced frequency. Extreme fatigue. Day 5 - symptoms continue to decrease. Day 6 - Can resume most normal activities with tolerable arm pain.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Product administered at inappropriate site, Tendonitis
Clinical narrative: Patient called pharmacy day of vaccination stating that her arm hurt. She came into the pharmacy on 11/14 stating that her arm still hurt and she was experiencing tendonitis which hurt worse than labor pains. She stated that she went to the emergency room and the doctor there told her that the vaccine must've been given too high up. She went to her primary care doctor and he/she also told her the same thing.
Age: 54.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Musculoskeletal stiffness, Pain, Torticollis
Clinical narrative: Torticuli, stiff neck associated with headache and body ache lasting approximately 6 weeks.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported in the patient; Patient received a vaccine following a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reported.       On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) ( GARDASIL 9) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported).         On 25-OCT-2019, it was detected the temperature excursion was lowest temperature below 36 degrees Fahrenheit (F)/ 2 degrees Celsius (35 Fahrenheit) for a time frame of 430 minutes, and no had the previous temperature excursion (product storage error).  It was reported that not call was due to data logger. No adverse effect were reported in the patient.    This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA000826: US-009507513-1911USA000833:
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported in the patient; patient received a vaccine following a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reported.    On an unknown date, the patient was vaccinated with hepatitis a vaccine, inactivated (VAQTA), one dose for prophylaxis (strength, frequency, route of administration, anatomical location, lot number and expiration date were not reported).        On 29-OCT-2019, it was detected the temperature excursion was lowest below 36 degrees Fahrenheit (F)/ 2 degrees Celsius (35 F) for a time frame of 430 minutes, and no had the previous temperature excursion (product storage error). It was reported that not call was due to data logger.  No adverse effect were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA000822: US-009507513-1911USA000833:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported in the patient; a patient received a vaccine following a temperature excursion; This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's pertinent medical history, concomitant therapies, as well as drug reactions or allergies were not reported.  On an unknown date, the patient was vaccinated with rotavirus vaccine, live, oral, pentavalent (ROTATEQ) for prophylaxis (strength, dose, frequency, route of administration, anatomical location, lot number and expiration date were not reported).         On 25-OCT-2019, it was detected the temperature excursion was lowest below 36 degrees Fahrenheit (F)/ 2 degrees Celsius (35 F) for a time frame of 430 minutes, and no had the previous temperature excursion (product storage error). It was reported that not call was due to data logger. No adverse effect were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1911USA000822: US-009507513-1911USA000826:
Sex: U
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 patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th November 2019, the patient received Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had sore arms.  No other details were provided. This case linked with US2019AMR206161, US2019205723 and US2019205719, reported by same reporter.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash pruritic
Clinical narrative: Rash that extended from back of neck to back / Rash was itchy; This case was reported by a pharmacist via call center representative and described the occurrence of itchy rash in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 14th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 21 days after receiving Shingrix, the patient experienced itchy rash. The patient was treated with methylprednisolone (Medrol). On an unknown date, the outcome of the itchy rash was unknown.   It was unknown if the reporter considered the itchy rash to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient who is also a retired pharmacist. The patient started to have a rash that extended from back of his neck to his back and the rash was itchy. The patient consented to follow up. This case has been linked with case US2019AMR206374, reported by the same reporter.