chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: UNK
Symptoms: Drug interaction, Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Rash become a darker red; Injection site get swollen; Injection site hot; Injection site itchy; Injection site sore; Injection site red rash; Possible drug interaction; This case was reported by a consumer via other and described the occurrence of injection site swelling in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included alirocumab (Praluent) for low density lipoprotein cholesterol.   Concurrent medical conditions included low density lipoprotein and cholesterol.   On 21st May 2019, the patient received the 1st dose of Shingrix. On 22nd April 2019, the patient started Praluent at an unknown dose and frequency. In July 2019, unknown after receiving Shingrix, the patient experienced drug interaction. On 16th July 2019, the patient experienced injection site swelling, injection site warmth, injection site itching, injection site pain and injection site rash. On 17th July 2019, the patient experienced red rash. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site itching, injection site pain, injection site rash and red rash were not recovered/not resolved and the outcome of the drug interaction was unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site itching, injection site pain, injection site rash and red rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. On 22nd April 2019, the patient received 1st dose of Praluent for the treatment of her Low density lipoprotein (LDL) cholesterol. The patient was currently on Praluent 150 mg every 2 weeks. For the 1st two injections, the patient had no reactions at all for the 1st month. On 15th July 2019, the patient had most recent injection of Praluent after Shingrix administration and the patient started having problems at the injection site every time when she receive a Praluent injection, which led to possible drug interaction. On the 1st day after the Praluent shot, the injection site got swollen, hot, itchy, sore and developed a little light red rash. By the 2nd day after an Praluent injection, 57 days after the Shingrix administration, the rash become a darker red and increased to about 2 inches in diameter. It took about a week to go away. The patient had been injecting the Praluent in her thigh, due to reactions, she tried it on her arm the day before reporting and seemed to be developing the same reactions. It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site itching, injection site pain, injection site rash and red rash to be related to Praluent, as well. No additional information was provided. For additional information, the reporter could be contacted directly.
Sex: F
Vaccine: UNK
Symptoms: Injection site warmth, Rash erythematous
Clinical narrative: Rash become a darker red; Injection site get swollen; Injection site hot; Injection site itchy; Injection site sore; Injection site red rash; Possible drug interaction; This case was reported by a consumer via other and described the occurrence of injection site swelling in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included alirocumab (Praluent) for low density lipoprotein cholesterol.   Concurrent medical conditions included low density lipoprotein and cholesterol.   On 21st May 2019, the patient received the 1st dose of Shingrix. On 22nd April 2019, the patient started Praluent at an unknown dose and frequency. In July 2019, unknown after receiving Shingrix, the patient experienced drug interaction. On 16th July 2019, the patient experienced injection site swelling, injection site warmth, injection site itching, injection site pain and injection site rash. On 17th July 2019, the patient experienced red rash. On an unknown date, the outcome of the injection site swelling, injection site warmth, injection site itching, injection site pain, injection site rash and red rash were not recovered/not resolved and the outcome of the drug interaction was unknown.   It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site itching, injection site pain, injection site rash and red rash to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. On 22nd April 2019, the patient received 1st dose of Praluent for the treatment of her Low density lipoprotein (LDL) cholesterol. The patient was currently on Praluent 150 mg every 2 weeks. For the 1st two injections, the patient had no reactions at all for the 1st month. On 15th July 2019, the patient had most recent injection of Praluent after Shingrix administration and the patient started having problems at the injection site every time when she receive a Praluent injection, which led to possible drug interaction. On the 1st day after the Praluent shot, the injection site got swollen, hot, itchy, sore and developed a little light red rash. By the 2nd day after an Praluent injection, 57 days after the Shingrix administration, the rash become a darker red and increased to about 2 inches in diameter. It took about a week to go away. The patient had been injecting the Praluent in her thigh, due to reactions, she tried it on her arm the day before reporting and seemed to be developing the same reactions. It was unknown if the reporter considered the injection site swelling, injection site warmth, injection site itching, injection site pain, injection site rash and red rash to be related to Praluent, as well. No additional information was provided. For additional information, the reporter could be contacted directly.
Sex: U
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: severe pain; joint pain; This case was reported by a other health professional via interactive digital media and described the occurrence of pain in arm in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th May 2019, the patient received the 2nd dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced pain in arm and pain in joint involving shoulder region. On an unknown date, the outcome of the pain in arm and pain in joint involving shoulder region were unknown.   It was unknown if the reporter considered the pain in arm and pain in joint involving shoulder region to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had severe pain in upper arms and shoulder joints. The patient asked how long will the events last. This case has been linked with case US2019AMR135411, reported by the same reporter.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction
Clinical narrative: Bad reaction; This case was reported by a pharmacist via call center representative and described the occurrence of adverse reaction in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number 99D9F, expiry date 14th April 2020) for prophylaxis.   On 27th April 2019, the patient received the 1st dose of Shingrix. On 27th April 2019, less than a day after receiving Shingrix, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown.   It was unknown if the reporter considered the adverse reaction to be related to Shingrix.  Additional case details were reported as follows: The reporter confirmed the shingles vaccine as Shingrix. The reporter gave permission to follow up. This case had been linked to the case US2019129925, reported for same patient.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: rash all over her body; This case was reported by a consumer via call center representative and described the occurrence of generalized rash in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included allergic skin reaction and immunocompromised.   On 12th July 2019, the patient received the 2nd dose of Shingrix .5 ml. In July 2019, several days after receiving Shingrix, the patient experienced generalized rash. On an unknown date, the outcome of the generalized rash was recovering/resolving.   It was unknown if the reporter considered the generalized rash to be related to Shingrix.  Additional information received were as follows: The patient report that within a few days after receiving of Shingrix in left arm, she experienced a rash developed all over her body. The patient described it as little dots on her torso, legs, neck and face.  The rash came and went but had not resolved and had become a little worse.  The reporter consented to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: small rash at injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site rash in a 68-year-old male patient who received Herpes zoster (Shingrix) (batch number CF9K4, expiry date 11th September 2021) for prophylaxis.   On 24th May 2019, the patient received the 1st dose of Shingrix. On 25th May 2019, 1 days after receiving Shingrix, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash was recovered/resolved.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The pharmacist reported that the patient received Shingrix and One day after, the patient had a small rash at the injection site, which resolved after a few days without any treatment. The reporter had consented to follow up. The case has been linked to the case US2019137612 reported by same reporter. There was discrepancy between the outcome reported in the structured field (recovered/ resolved) and the outcome reported in the source document (recovered/resolved with sequel).
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Muscle spasms, Pain in extremity
Clinical narrative: Pain in arm; Headaches; muscle spasms; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain in arm, headache and muscle spasm. On an unknown date, the outcome of the pain in arm, headache and muscle spasm were unknown.   It was unknown if the reporter considered the pain in arm, headache and muscle spasm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the vaccine Shingrix injection and had terrible pain in arm, headaches and muscle spasms on and off. The reporter was calling on the behalf of her friend and reporter very limited details. The reporter refused to provide any additional details.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Inflammation, Swelling
Clinical narrative: Pain/ right knee; Inflammation; Swelling; This case was reported by a pharmacist via call center representative and described the occurrence of pain ankle in a 54-year-old female patient who received Herpes zoster (Shingrix) (batch number ZG47A, expiry date 12th February 2021) for prophylaxis.   On 24th January 2019, the patient received the 2nd dose of Shingrix. On 27th January 2019, 3 days after receiving Shingrix, the patient experienced pain ankle, inflammation and swelling. On an unknown date, the outcome of the pain ankle, inflammation and swelling were unknown.   It was unknown if the reporter considered the pain ankle, inflammation and swelling to be related to Shingrix.  Additional details were provided as follows: The patient started experiencing right knee and ankle pain, inflammation and swelling, which happened to be on the same side of the injection. The reporter consented to follow up.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Pruritus generalised, Swelling of eyelid, Urticaria
Clinical narrative: Generalized Itching; Hives; Shortness of breath/Difficulty breathing; Swollen eyelids; This case was reported by a other health professional via call center representative and described the occurrence of generalized pruritus in a 34-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 525NP, expiry date 4th September 2021) for prophylaxis.   On 26th July 2019, the patient received Boostrix. On 26th July 2019, 30 min after receiving Boostrix, the patient experienced generalized pruritus (serious criteria clinically significant/intervention required), hives (serious criteria clinically significant/intervention required), shortness of breath (serious criteria clinically significant/intervention required) and swelling of eyelid (serious criteria clinically significant/intervention required). The patient was treated with diphenhydramine hydrochloride (Children'S Benadryl (Diphenhydramine Hcl)) and epinephrine. On an unknown date, the outcome of the generalized pruritus, hives, shortness of breath and swelling of eyelid were unknown.   It was unknown if the reporter considered the generalized pruritus, hives, shortness of breath and swelling of eyelid to be related to Boostrix.  Additional details were provided as follows: The Certified Medical Assistant (CMA) reported these adverse events on behalf of physician (MD). At about 30 minutes later, the patient started to experience generalized itching and hives and children's Benadryl was administered to her.  About 45 minutes later, the patient started experiencing swollen eyelids and difficulty breathing and the EMS (emergency medical service) was called.  The patient then started to experience worsening shortness of breath and 0.4 mg of Epinephrine was administered to her.  The patient was taken to the ER (emergency room) for further evaluation. The reporter consented to follow up.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Pain, Somnolence
Clinical narrative: flu-like symptoms; Feeling Sleepy; Headache; Body ache; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 67-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 30th July 2019, several hours after receiving Shingrix, the patient experienced influenza-like symptoms, sleepiness, headache and general body pain. On an unknown date, the outcome of the influenza-like symptoms, sleepiness, headache and general body pain were not recovered/not resolved.   It was unknown if the reporter considered the influenza-like symptoms, sleepiness, headache and general body pain to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient herself. On 30th July 2019 morning, the patient received a dose of Shingrix in right deltoid and at night, the patient started experiencing flu-like symptoms, feeling sleepy, headache and body ache (pain). The symptoms were still the same today at the day of reporting. The reporter consented to follow up.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Crying, Hypokinesia, Malaise, Pain, Paralysis
Clinical narrative: difficulty moving; felt paralyzed/ her ribs and spine locked; sick; throwing up; crying hysterically; in pain; This case was reported by a consumer via call center representative and described the occurrence of paralysis in a 66-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 33CA7, expiry date 30th January 2020) for prophylaxis.   Concurrent medical conditions included laceration of finger (the patient was seen at hospital emergency).   On 29th June 2019, the patient received the 1st dose of Boostrix (intramuscular) .5 ml. In June 2019, less than a day after receiving Boostrix, the patient experienced paralysis (serious criteria GSK medically significant), sickness, vomiting, crying and pain. On an unknown date, the patient experienced movements reduced. On an unknown date, the outcome of the paralysis, sickness, vomiting, crying, pain and movements reduced were recovering/resolving.   The reporter considered the paralysis, sickness, vomiting, crying, pain and movements reduced to be related to Boostrix.  Additional details were reported as follows: The patient was consented to the vaccine administration after being scared to death by the doctor she states.  The patient noted she did not want the vaccine. The patient received Boostrix on the right deltoid. The patient noted that for 32 days now she had been sick, throwing up, crying hysterically, in pain, difficulty moving, saying her ribs and spine locked up she felt paralyzed. The issues were improving but not resolved. She did saw a physician about these events, noted she saw several. The patient upon call the patient was upset, hard to get specific information from. The patient had spent 600 dollars and trying to get better from vaccine, but didn't request reimbursement or mention legal. But reporter was very upset this product on the market and causing these issues.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Vomiting
Clinical narrative: difficulty moving; felt paralyzed/ her ribs and spine locked; sick; throwing up; crying hysterically; in pain; This case was reported by a consumer via call center representative and described the occurrence of paralysis in a 66-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 33CA7, expiry date 30th January 2020) for prophylaxis.   Concurrent medical conditions included laceration of finger (the patient was seen at hospital emergency).   On 29th June 2019, the patient received the 1st dose of Boostrix (intramuscular) .5 ml. In June 2019, less than a day after receiving Boostrix, the patient experienced paralysis (serious criteria GSK medically significant), sickness, vomiting, crying and pain. On an unknown date, the patient experienced movements reduced. On an unknown date, the outcome of the paralysis, sickness, vomiting, crying, pain and movements reduced were recovering/resolving.   The reporter considered the paralysis, sickness, vomiting, crying, pain and movements reduced to be related to Boostrix.  Additional details were reported as follows: The patient was consented to the vaccine administration after being scared to death by the doctor she states.  The patient noted she did not want the vaccine. The patient received Boostrix on the right deltoid. The patient noted that for 32 days now she had been sick, throwing up, crying hysterically, in pain, difficulty moving, saying her ribs and spine locked up she felt paralyzed. The issues were improving but not resolved. She did saw a physician about these events, noted she saw several. The patient upon call the patient was upset, hard to get specific information from. The patient had spent 600 dollars and trying to get better from vaccine, but didn't request reimbursement or mention legal. But reporter was very upset this product on the market and causing these issues.
Sex: U
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in an unspecified number of adult patients who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain 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 an adult as per vaccine indication. The reporter stated that lot of patients had reported pain after receiving a dose of Shingrix.
Sex: U
Vaccine: PNC13
Symptoms: Condition aggravated, Systemic lupus erythematosus
Clinical narrative: Had terrible flare of lupus; This is a spontaneous report from a contactable pharmacist via medical information team. A patient of unspecified age and gender received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13), via an unspecified route of administration at the end of May2019 at single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient had terrible flare of lupus on an unspecified date in 2019 with outcome of unknown.  Information on the batch number has been requested.; Sender's Comments: Event flare of lupus is likely due to the intercurrent condition and unrelated to PREVNAR 13.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: U
Vaccine: MENB, MNQ
Symptoms: Loss of consciousness, Seizure
Clinical narrative: had a seizure; passed out; This is a spontaneous report from contactable nurse via Pfizer Sales Representative.   A 17-year-old male patient received the 1st dose of meningococcal group b rlp2086 (TRUMENBA) at single dose, and meningococcal vaccine a/c/y/w conj (dip tox) (MENACTRA), both on an unspecified date for immunization.  The patient medical history and concomitant medications were not reported.  The patient passed out and had a seizure on an unspecified date within minutes of receiving vaccines. The Patient recovered within a minute and was quickly aware of surroundings.  Information on the lot/batch number has been requested.; Sender's Comments: Based on the information currently available, a contributory role of TRUMENBA towards the occurrence of events passed out and seizure cannot be fully excluded.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 52.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: The patient reported that left upper arm was very painful that evening and redness developed.  At his appointment for wound care on 08/02/19, arm redness with mild induration measuring 20.5 x 26 cm was noted on his left upper arm.  He was seen by APN at the wound center and prescriberd Keflex 500mg 1 tab po every six hours x 7 days for both the right foot wound and the left arm.
Age: 0.75
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Abnormal behaviour, Decreased eye contact, Disturbance in social behaviour, Dyskinesia, Electroencephalogram normal
Clinical narrative: Symptoms started with a high fever for a few days, then a bumpy rash developed and behavior started to change.  He was a very happy baby until around 1-2 weeks after the vaccines he became very serious and appeared scared frequently.  Decreased eye contact and social behavior.  Regressed in the physical use of his hands.  He stopped holding his bottle for himself, stopping holding onto the shopping cart for balance.  Started to hold hands in tight little fists at his waist and overall decreased the use of his hands.  During the night 5/15/19 he woke up screaming and seemed frightened, while nursing him at the breast  his body started jolting around like a seizure and then he fell asleep.  This happened twice that same night.  Went to doctor the next day and he ordered an EEG that was completed on 5/24/19 and came back normal.     My little boy continued to behave differently for around 2 months post vaccination.  He now seems like he is returning to his normal self.
Age: 0.75
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Fear, Middle insomnia, Pyrexia, Rash, Screaming
Clinical narrative: Symptoms started with a high fever for a few days, then a bumpy rash developed and behavior started to change.  He was a very happy baby until around 1-2 weeks after the vaccines he became very serious and appeared scared frequently.  Decreased eye contact and social behavior.  Regressed in the physical use of his hands.  He stopped holding his bottle for himself, stopping holding onto the shopping cart for balance.  Started to hold hands in tight little fists at his waist and overall decreased the use of his hands.  During the night 5/15/19 he woke up screaming and seemed frightened, while nursing him at the breast  his body started jolting around like a seizure and then he fell asleep.  This happened twice that same night.  Went to doctor the next day and he ordered an EEG that was completed on 5/24/19 and came back normal.     My little boy continued to behave differently for around 2 months post vaccination.  He now seems like he is returning to his normal self.
Age: 0.75
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Seizure like phenomena
Clinical narrative: Symptoms started with a high fever for a few days, then a bumpy rash developed and behavior started to change.  He was a very happy baby until around 1-2 weeks after the vaccines he became very serious and appeared scared frequently.  Decreased eye contact and social behavior.  Regressed in the physical use of his hands.  He stopped holding his bottle for himself, stopping holding onto the shopping cart for balance.  Started to hold hands in tight little fists at his waist and overall decreased the use of his hands.  During the night 5/15/19 he woke up screaming and seemed frightened, while nursing him at the breast  his body started jolting around like a seizure and then he fell asleep.  This happened twice that same night.  Went to doctor the next day and he ordered an EEG that was completed on 5/24/19 and came back normal.     My little boy continued to behave differently for around 2 months post vaccination.  He now seems like he is returning to his normal self.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, Injection site erythema, Injection site oedema
Clinical narrative: received 2 doses of Havrix (pediatric) 11 days apart---redness and edema at injection site
Age: 24.0
Sex: F
Vaccine: MMR, MMR, TDAP
Symptoms: Fall, Headache, Presyncope, Skin laceration
Clinical narrative: Patient was given  Tdap and MMR immunization. Patient tolerated Tdap well. After giving  patient MMR immunization patient had a vasovagal response and fell off of exam table. Provider was unable to stop patient from falling off of exam table. During fall patient obtained laceration about right eye from glasses breaking. Patient woke up and was alert and oriented x4. She denied being light headed or dizzy. She did state that her head hurt where she obtained laceration. Patient was able to sit in exam room and wait for her sister to pick her up and take her to ER. Patients daughter was in the room during incident as well. Other staff came to help during incident.
Age: 24.0
Sex: F
Vaccine: MMR, MMR, TDAP
Symptoms: Burning sensation, Fall, Presyncope, Skin laceration
Clinical narrative: Patient was given  Tdap and MMR immunization. Patient tolerated Tdap well. After giving  patient MMR immunization patient had a vasovagal response and fell off of exam table. Provider was unable to stop patient from falling off of exam table. During fall patient obtained laceration about right eye from glasses breaking. Patient woke up and was alert and oriented x4. She denied being light headed or dizzy. She did state that her head hurt where she obtained laceration. Patient was able to sit in exam room and wait for her sister to pick her up and take her to ER. Patients daughter was in the room during incident as well. Other staff came to help during incident.
Age: 17.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Dehydration, Loss of consciousness, Presyncope, Seizure, Unresponsive to stimuli
Clinical narrative: This was administering the Meningitis and HPV vaccine to the patient when he suddenly became unresponsive and was convulsing. The patient was unresponsive for approximately 5-10 seconds and had 2-3 noticeable convulsions prior to regaining consciousness and sitting up. Also present in the shot room was the patient?s mother and younger brother. The patient was seated in the clinic bench, when the vaccine administration occurred. This PHN administered the meningitis vaccine in the patient?s left deltoid without concerns. This PHN then administered the HPV vaccine in the patient?s right deltoid, and within seconds the patient slumped into the chair and his body convulsed 2-3 times. This PHN braced the patient on the bench and attempted to lean him over slightly, but the patient?s brother was also seated on the bench still. After 5-10 seconds the patient regained consciousness. This PHN continued to assess the patient and reassure the mother that this is a known reaction to vaccination, and the HPV vaccine. This PHN also inquired about hydration status, and expressed concerns about the patient being slightly dehydrated as well. This PHN explained that the convulsions didn?t appear to be seizure related, but that the patient?s primary provider should be made aware of the incident. This PHN check the patient?s blood pressure and it was 126/68, pulse 55, and SPO2 99%. This PHN then asked for Dr. to assess the patient. Dr. assessed the patient and stated that his pulse was slightly low but otherwise normal findings. Dr. reassured the mother that her son was likely slightly dehydrated and additionally had a vasovagal reaction to the vaccination. Dr, also explained that the convulsions were the body?s response to the shifting of blood from the brain and decreased heart rate, and likely not seizure related due to lack of post ictal state. The family remained in the clinic for approximately 30 minutes after the appointment time for assessment and reassurance. This PHN documented the vaccination reaction.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Cough, Dizziness, Headache, Malaise
Clinical narrative: Patient's wife stated he became very ill Monday afternoon with a 102 degree fever, cough, chills, aches/pains, headache, nausea, and dizziness. He was rushed to the ER Monday afternoon at 3pm. He was discharged today with a prescription for Levaquin and Tessalon Pearles with a Pneumonia diagnosis. Wife states it was the vaccine that caused his illness.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pneumonia, Pyrexia
Clinical narrative: Patient's wife stated he became very ill Monday afternoon with a 102 degree fever, cough, chills, aches/pains, headache, nausea, and dizziness. He was rushed to the ER Monday afternoon at 3pm. He was discharged today with a prescription for Levaquin and Tessalon Pearles with a Pneumonia diagnosis. Wife states it was the vaccine that caused his illness.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Injection site reaction, Mobility decreased, Pain in extremity
Clinical narrative: Patient had severe sore arm  that she could hardly lift arm for  2  days. Also patient is on Warfarin. She had " substantial" bruising under  her armpit according to her report. Contacted her primary physician who assured her that this was one of expected reactions and advised her to take some Tylenol and compresses on  injection site. She , however, was using warm compress.  She later sough further medical attention at urgent care.  There she was evaluated and advised that it is an unusual reaction  but would be okay. Today 8/6/2019 at time of reporting  patient is okay and bruising subsiding.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Rash
Clinical narrative: Kinrix was given. this was his 5th dtap and his 4th ipv. Rash from head to toe within 5 minutes of injections. No local reaction in arms. no respiratory involvement . order given by Dr. to give 25 mg of liquid Benadryl. Rash starting fading within 10 to 15 minutes. dad said he had no problems at all after that.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Neck pain, Pain, Vaccination site pain
Clinical narrative: Soon after vaccination had severe pain at vaccine area that began to extend to neck and to right side of body.  Patient called doctor but was not able to reach them; has not heard back from them yet.   Patient took Tylenol for pain and it did help.   Pain at vaccination site still there but not as severe and still having problems on right side of body.  Patient has been trying to rest most to recover.  Also had uncontrollable diarrhea which started night of vaccination.  Patient tried to control what she was eating and drinking to get better; there were a couple of episodes lasting through morning.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Rash vesicular, Swelling
Clinical narrative: Approximately three days after the Shingrix vaccine  I developed  what looked like a patch of Shingles rash on the right side of my body on my  waist above my hip bone. The patch was red and raised and hurt to the touch. Three days after that I stopped by the pharmacy to ask the pharmacist if this was normal. She told me to report the reaction. A week after recieiving the vaccine I still have the patch, it is still sore but not as bad.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Chills, Chromaturia, Headache, Rash, Taste disorder
Clinical narrative: Rash, headache, bad taste in mouth, chills  Starting 8/1/19  Urine orange in color starting 8/4/19
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure decreased, Chills, Dizziness, Muscular weakness, Pain in extremity
Clinical narrative: Pain in arm Drop in blood pressure  Dizziness Chills Weakness in legs and arms
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Fall, Head injury, Malaise, Pallor
Clinical narrative: Patient left office, alert and oriented, after receiving TDAP vaccination. No complaints noted. Patient reported to wife in elevator outside office after leaving that he was not feeling well. Patient then fell to floor of elevator, noted to hit back of head on elevator floor. No loss of consciousness noted. Patient assisted to a sitting position by staff and after sitting for a couple of minutes began to regain color to skin, alert and oriented to person, place, and time. Denied pain.  Per staff members, patient was assisted to wheelchair and escorted to Emergency Department. Patient refused treatment at Emergency Department but stated that he was feeling much better after about 15 -20 minutes and consuming sprite and crackers.  Spoke with patient again around 4:00 PM, patient states that he is feeling much better, denies pain, nausea/vomiting/ dizziness. States, " I am home and I am fine."
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Nausea, Vomiting
Clinical narrative: Injection site soreness and pain, with swelling and tenderness, worsening throughout day. Pt c/o N/V. Pt was taken to local ER, given solumedrol, ranitidine, and and benadryl IVP. Pt remained stable and VSS throughout. Discharged that night.
Age: 22.0
Sex: F
Vaccine: HPV9
Symptoms: Swelling
Clinical narrative: Significant swelling of the shoulder area. Currently still swollen on 8/6/2019, five days post injection.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported.     On an unspecified date in 2016, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) by a healthcare provider at a medical office for the long-term prevention of shingles and zoster-related conditions (Strength, dose, route of administration, lot # and expiration date were not reported).        Subsequently to Plaintiff's zoster vaccine live(ZOSTAVAX) inoculation, Plaintiff was treated by a healthcare provider for shingles for which the pt was hospitalized (No dates reported). As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX), Plaintiff had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.   The outcome of shingles was reported as not recovered.    The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; Information has been received regarding a case in litigation from a lawyer concerning a female patient of unknown age. Her medical history, concurrent conditions and concomitant medications were not reported.     On an unspecified date in 2015, the pt was vaccinated with a dose of zoster vaccine live(ZOSTAVAX) by a healthcare provider at a medical office for the long-term prevention of shingles and zoster-related conditions (Strength, dose, route of administration, lot # and expiration date were not reported).        Subsequently to Plaintiff's zoster vaccine live(ZOSTAVAX) inoculation, Plaintiff was treated by a physician for shingles for which the pt was hospitalized (No dates reported). As a direct and proximate result of Plaintiff's use of the zoster vaccine live(ZOSTAVAX), Plaintiff had and would continue suffering ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.   The outcome of shingles was reported as not recovered.    The reporter considered shingles to be related to Zoster Vaccine Live(ZOSTAVAX).
Age: 9.0
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse effects; the patient was inadvertently administered an expired dose Varivax on 22-AUG-2014; This spontaneous report as received from a nurse referring  to a 9-year-old patient, gender was not reported. No information regarding patient's concurrent conditions, medical history, drug allergies or reactions were provided.    On 22-AUG-2014, the patient was inadvertently vaccinated with an expired dose of varicella virus vaccine live (oka/merck)(VARIVAX) lot # H015560, expiration date 16-AUG-2014,  for prophylaxis (strength, dose, frequency, anatomical site of administration and route were not reported) (expired product administered). A sterile diluent used was mention, no adverse effects were reported. The events outcome was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal
Clinical narrative: shivers/ teeth chattering; feeling miserable; This case was reported by a medical representative via call center representative and described the occurrence of shivers in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shivers and feeling miserable. On an unknown date, the outcome of the shivers and feeling miserable were unknown.   It was unknown if the reporter considered the shivers and feeling miserable to be related to Shingrix.  Additional details were provided as follows: Adverse event receipt was given to the sales representative during the call. The adverse event which was made known to medical representative by a physician via email sent in March 2019. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The physician's email reportedly quoted an email sent to him by a patient, which stated that the patient felt miserable and experienced shivering and teeth chattering after receiving Shingrix. The reporter did not consent to follow-up. The sales representative was reportedly on medical leave at the time and did not notice the email until recently. The sales representative stated that she wanted to call the adverse event into Medical Information instead to report the adverse event due to the adverse event being reported late. No other information was available, besides the healthcare provider's details. This case has been linked with US2019139663, US2019AMR141888 and US2019AMR141889 reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal
Clinical narrative: shivers/ teeth chattering; feeling miserable; This case was reported by a medical representative via call center representative and described the occurrence of shivers in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shivers and feeling miserable. On an unknown date, the outcome of the shivers and feeling miserable were unknown.   It was unknown if the reporter considered the shivers and feeling miserable to be related to Shingrix.  Additional details were provided as follows: Adverse event receipt was given to the sales representative during the call. The adverse event which was made known to medical representative by a physician via email sent in March 2019. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The physician's email reportedly quoted an email sent to him by a patient, which stated that the patient felt miserable and experienced shivering and teeth chattering after receiving Shingrix. The reporter did not consent to follow-up. The sales representative was reportedly on medical leave at the time and did not notice the email until recently. The sales representative stated that she wanted to call the adverse event into Medical Information instead to report the adverse event due to the adverse event being reported late. No other information was available, besides the healthcare provider's details. This case has been linked with US2019139663, US2019AMR141887 and US2019AMR141889 reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal
Clinical narrative: shivers/ teeth chattering; feeling miserable; This case was reported by a medical representative via call center representative and described the occurrence of shivers in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shivers and feeling miserable. On an unknown date, the outcome of the shivers and feeling miserable were unknown.   It was unknown if the reporter considered the shivers and feeling miserable to be related to Shingrix.  Additional details were provided as follows: Adverse event receipt was given to the sales representative during the call. The adverse event which was made known to medical representative by a physician via email sent in March 2019. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The physician's email reportedly quoted an email sent to him by a patient, which stated that the patient felt miserable and experienced shivering and teeth chattering after receiving Shingrix. The reporter did not consent to follow-up. The sales representative was reportedly on medical leave at the time and did not notice the email until recently. The sales representative stated that she wanted to call the adverse event into Medical Information instead to report the adverse event due to the adverse event being reported late. No other information was available, besides the healthcare provider's details. This case has been linked with US2019139663, US2019AMR141887 and US2019AMR141888 reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Feeling abnormal
Clinical narrative: shivers/ teeth chattering; feeling miserable; This case was reported by a medical representative via call center representative and described the occurrence of shivers in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than 2 years after receiving Shingrix, the patient experienced shivers and feeling miserable. On an unknown date, the outcome of the shivers and feeling miserable were unknown.   It was unknown if the reporter considered the shivers and feeling miserable to be related to Shingrix.  Additional details were provided as follows: Adverse event receipt was given to the sales representative during the call. The adverse event which was made known to medical representative by a physician via email sent in March 2019. The age at vaccination was not reported. The age group was not reported, but was selected as adult as per vaccine indication. The physician's email reportedly quoted an email sent to him by a patient, which stated that the patient felt miserable and experienced shivering and teeth chattering after receiving Shingrix. The reporter did not consent to follow-up. The sales representative was reportedly on medical leave at the time and did not notice the email until recently. The sales representative stated that she wanted to call the adverse event into Medical Information instead to report the adverse event due to the adverse event being reported late. No other information was available, besides the healthcare provider's details. This case has been linked with US2019AMR141887, US2019AMR141888 and US2019AMR141889, reported by the same reporter.
Sex: F
Vaccine: UNK
Symptoms: Crying, Vomiting
Clinical narrative: Forceful vomit through mouth and nose, no treatment, currently resting after crying
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Localised oedema, Paraesthesia
Clinical narrative: LOCALIZED EDEMA THAT RESULTED IN PARASTHESIA OF SHOULDER
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Differential white blood cell count normal, Electroencephalogram normal, Full blood count normal, Metabolic function test normal, Seizure
Clinical narrative: Exactly 9 days following this vaccine my daughter experienced her first seizure. These continued periodically for about one year.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Cough, Vomiting, Wheezing
Clinical narrative: Mom reports started wheezing and coughing on Sunday 08/04/2019, started vomiting today 08/06/2019