chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Neck pain, Pain, Pain in extremity, Pyrexia
Clinical narrative: fever; Itchy bumps; Blister; left arm pain radiated to her elbow and up to her neck; Neck pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2019, the patient received the 2nd dose of Shingrix. On 22nd August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and neck pain. On 23rd August 2019, the patient experienced fever, itchy rash and blister. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm, neck pain, fever, itchy rash and blister were unknown.   It was unknown if the reporter considered the pain in arm, neck pain, fever, itchy rash and blister to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. On the same day of vaccination, the patient experienced left arm pain which radiated to her elbow and up to her neck for which she took ibuprofen and this resolved. 1 day after receiving Shingrix, the patient experienced slight fever and took ibuprofen and this resolved. The patient stated that from Friday, 1 day after receiving Shingrix, she experienced bumps which started near the elbow of the left arm which spread to left wrist, then near her right eye, then wrist of the right arm, then hair line, then near nose, then near right eye brow and then the back of the neck and blisters. The bumps were ongoing.  The patient stated these bumps were itchy.  The reporter consented to follow up.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: fever; Itchy bumps; Blister; left arm pain radiated to her elbow and up to her neck; Neck pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd August 2019, the patient received the 2nd dose of Shingrix. On 22nd August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm and neck pain. On 23rd August 2019, the patient experienced fever, itchy rash and blister. The patient was treated with ibuprofen. On an unknown date, the outcome of the pain in arm, neck pain, fever, itchy rash and blister were unknown.   It was unknown if the reporter considered the pain in arm, neck pain, fever, itchy rash and blister to be related to Shingrix.  Additional information received were as follows: The patient received Shingrix on left arm. On the same day of vaccination, the patient experienced left arm pain which radiated to her elbow and up to her neck for which she took ibuprofen and this resolved. 1 day after receiving Shingrix, the patient experienced slight fever and took ibuprofen and this resolved. The patient stated that from Friday, 1 day after receiving Shingrix, she experienced bumps which started near the elbow of the left arm which spread to left wrist, then near her right eye, then wrist of the right arm, then hair line, then near nose, then near right eye brow and then the back of the neck and blisters. The bumps were ongoing.  The patient stated these bumps were itchy.  The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Decreased appetite, Depression, Injection site pain, Malaise, Muscular weakness
Clinical narrative: Loss of appetite; Nausea; Muscle weakness; Got very depressed; Really sick / Not feeling well; Soreness at injection site; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2019, the patient received the 1st dose of Shingrix. On 12th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and fever. On 8th August 2019, the patient experienced appetite lost, nausea, muscle weakness, depression and feeling unwell. On an unknown date, the outcome of the injection site pain, fever, appetite lost, nausea, muscle weakness, depression and feeling unwell were unknown.   It was unknown if the reporter considered the injection site pain, fever, appetite lost, nausea, muscle weakness, depression and feeling unwell to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The reporter stated that, the patient experienced soreness at the injection site and a low-grade fever on day of reporting, but nothing more severe than that. On 8th August 2019, 27 days after vaccination, the patient got really sick with a fever, loss of appetite, nausea, severe muscle weakness, and got very depressed. The patient still had some muscle weakness and her "appetite was not back," but the depression was somewhat better. The patient did not feel good this past weekend. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Loss of appetite; Nausea; Muscle weakness; Got very depressed; Really sick / Not feeling well; Soreness at injection site; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th July 2019, the patient received the 1st dose of Shingrix. On 12th July 2019, less than a day after receiving Shingrix, the patient experienced injection site pain and fever. On 8th August 2019, the patient experienced appetite lost, nausea, muscle weakness, depression and feeling unwell. On an unknown date, the outcome of the injection site pain, fever, appetite lost, nausea, muscle weakness, depression and feeling unwell were unknown.   It was unknown if the reporter considered the injection site pain, fever, appetite lost, nausea, muscle weakness, depression and feeling unwell to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. The reporter stated that, the patient experienced soreness at the injection site and a low-grade fever on day of reporting, but nothing more severe than that. On 8th August 2019, 27 days after vaccination, the patient got really sick with a fever, loss of appetite, nausea, severe muscle weakness, and got very depressed. The patient still had some muscle weakness and her "appetite was not back," but the depression was somewhat better. The patient did not feel good this past weekend. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Influenza like illness, Injection site pain, Sluggishness
Clinical narrative: burning at the injection site as dose was being administered; flu like symptoms; feeling sluggish; This case was reported by a other health professional via sales rep and described the occurrence of injection site burning in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date). Concurrent medical conditions included breast cancer.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced injection site burning, influenza-like symptoms and sluggishness. On an unknown date, the outcome of the injection site burning, influenza-like symptoms and sluggishness were unknown.   It was unknown if the reporter considered the injection site burning, influenza-like symptoms and sluggishness to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication. The patient had both doses of the Shingrix and experienced burning at the injection site as dose was being administered, flu like symptoms and feeling sluggish. The reporter gave permission to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash at injection site; This case was reported by a physician via call center representative and described the occurrence of injection site rash in a 73-year-old female 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 injection site rash. On an unknown date, the outcome of the injection site rash was unknown.   It was unknown if the reporter considered the injection site rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient developed injection site rash, following vaccination with dose of Shingrix. The reporter did not consent to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Fever; Swelling; Hot area; Pain; Redness; Itching; Chills; Muscle aches; Flu Like Symptoms; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 12th August 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, muscle pain, influenza-like symptoms, injection site swelling, injection site warmth, injection site pain and injection site erythema. In August 2019, the patient experienced injection site itching. On an unknown date, the outcome of the fever, chills, muscle pain, influenza-like symptoms, injection site swelling and injection site pain were recovered/resolved and the outcome of the injection site warmth, injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, muscle pain, influenza-like symptoms, injection site swelling, injection site warmth, injection site pain, injection site erythema and injection site itching to be related to Shingrix.  Additional details were reported as follows: The patient reported that the day after vaccination she woke up with fever, chills, muscle ache and flu like symptoms. She had a low grade fever that lasted for 2 days. The chills, muscle ache and flu like symptoms lasted for about a day and a half.  The patient also experienced redness, swelling, pain and hot area on the injection site covering an area of one and half inches by 3 inches.  It was not painful or swollen anymore. The area was still red and now the patient was experiencing itching. The reporter consented to follow up.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Pyrexia
Clinical narrative: Fever; Swelling; Hot area; Pain; Redness; Itching; Chills; Muscle aches; Flu Like Symptoms; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th August 2019, the patient received the 1st dose of Shingrix (intramuscular). On 12th August 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, muscle pain, influenza-like symptoms, injection site swelling, injection site warmth, injection site pain and injection site erythema. In August 2019, the patient experienced injection site itching. On an unknown date, the outcome of the fever, chills, muscle pain, influenza-like symptoms, injection site swelling and injection site pain were recovered/resolved and the outcome of the injection site warmth, injection site erythema and injection site itching were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, muscle pain, influenza-like symptoms, injection site swelling, injection site warmth, injection site pain, injection site erythema and injection site itching to be related to Shingrix.  Additional details were reported as follows: The patient reported that the day after vaccination she woke up with fever, chills, muscle ache and flu like symptoms. She had a low grade fever that lasted for 2 days. The chills, muscle ache and flu like symptoms lasted for about a day and a half.  The patient also experienced redness, swelling, pain and hot area on the injection site covering an area of one and half inches by 3 inches.  It was not painful or swollen anymore. The area was still red and now the patient was experiencing itching. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; This case was reported by a consumer via call center representative and described the occurrence of fever in a adult male 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 fever. On an unknown date, the outcome of the fever was unknown.   It was unknown if the reporter considered the fever 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 per the vaccine indication. The patient experienced fever after receiving Shingrix. The patient did not consent to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Rash, Rash pruritic, Urticaria
Clinical narrative: The rash on right foot, right calf, right groin, right armpit, left thigh and left scalp; swollen/fluid-filled bumps; hives; itchy rash; red; This case was reported by a consumer via call center representative and described the occurrence of rash in a 80-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th August 2019, the patient received the 1st dose of Shingrix. On 23rd August 2019, 14 days after receiving Shingrix, the patient experienced rash, blister, hives, itchy rash and erythema. On an unknown date, the outcome of the rash was not recovered/not resolved and the outcome of the blister, hives, itchy rash and erythema were unknown.   It was unknown if the reporter considered the rash, blister, hives, itchy rash and erythema to be related to Shingrix.  Additional details were provided as follows: The caller was a patient. The patient received Shingrix and developed an itchy rash with hives and red, swollen, fluid-filled bumps. The rash was on the patient's right foot, right calf, right groin, right armpit, left thigh and left scalp. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: Achy; Flu like symptoms; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a adult 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, less than 2 years after receiving Shingrix, the patient experienced pain and influenza-like symptoms. On an unknown date, the outcome of the pain and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the pain and influenza-like symptoms to be related to Shingrix.  Additional details were privided as follows: The reporter reported that, the patient was around 62 years old. The age at vaccination was not reported. The pharmacist reported that, the patient experienced pain and influenza like symptoms for 1 week after dose of Shingrix. The reporter reported that, the patient was due for the 2nd dose opf Shingrix, but did not want to get because opf adverse effect experienced after 1st dose. The responsible physician's information, any details regarding vaccine, and any further details regarding the event were unknown. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Monoplegia
Clinical narrative: paralyzed from his arm down; This case was reported by a consumer via call center representative and described the occurrence of monoplegia in a male 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 monoplegia (serious criteria GSK medically significant). On an unknown date, the outcome of the monoplegia was unknown.   It was unknown if the reporter considered the monoplegia to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter saw on a national news broadcast a man who became paralyzed from his arm down following Shingrix vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Guillian Barre syndrome; This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Flu unspecified (Influenza vaccine) for prophylaxis.   On an unknown date, the patient received Influenza vaccine at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown.   The reporter considered the guillain barre syndrome to be related to Influenza vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient got Guillain Barre syndrome from a flu vaccine many years ago. The reporter did not know who made that vaccine and has no information on the patient as it was not his customer.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Arthritis, Immediate post-injection reaction, Pain in extremity, X-ray limb abnormal
Clinical narrative: pain in her arm; mild arthritis into the shoulder; This is a spontaneous report from a contactable consumer and other healthcare professional (Physician Assistant, primary care provider family medicine). A 65-year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13, Batch/lot number: AA7118, Expiry Date: May2021), via an unspecified route of administration administered to the left deltoid on 13Aug2019 at 0.5 ml, single for immunization/prevention in physician office.  Medical history included osteoarthritis from an unknown date and unknown if ongoing.  The patient's concomitant medications were not reported. The patient experienced pain in her arm on 13Aug2019 and this term was highlighted by the reporter. The reporter considered the event pain in her arm was medically significant. The patient had pain in her arm she didn't want it to be 3 months later whenever or if her arm gets worse and it was not reported. The reporter did not know if indeed the pain in the patient's arm was caused by the vaccine because the patient also had osteoarthritis.  The pain in the patient's arm started immediately that day after being given the vaccine and so they were attributing it to the vaccine. They did see the patient back in the office on 28Aug2019 and did an X-ray and noted mild arthritis into the shoulder. They have referred her to physical therapy.  The patient ended up calling the office a few days after the injection and they recommended her to use paracetamol (TYLENOL) and heat pads to make her more comfortable. The event 'arm pain after the injection was given' required a visit to physician office. The outcome of the event pain in her arm was not resolved, the outcome of mild arthritis into the shoulder was unknown. The results of tests and procedures for investigation of the patient included:  X-ray on 28Aug2019 with result mild arthritis. The reporter assessed the event pain in her arm is adverse event to pneumococcal 13-val conj vac (dipht crm197 protein).; Sender's Comments: The event pain in arm is considered related to PREVNAR 13 based on temporal association and currently known drug profile of the suspected vaccine.  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: F
Vaccine: PNC13
Symptoms: Allergy to vaccine
Clinical narrative: Allergic to Prevnar 13 due to tetanus in it; This is a spontaneous report from a Pfizer sponsored program Pfizer RXPathways. A contactable physician reported that a 78-year-old female patient received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (PREVNAR 13) via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The patient was allergic to pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) due to tetanus in it. She could not have pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) due to Diptheria and Tetanus Toxoid In injection. The outcome of event was unknown.  Information on the batch number has been requested.
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Flu; This is a spontaneous case initially received from other non-health professional on 28-Aug-2019, concerning a male patient of an unknown age..  The patient's relevant medical history included epilepsy (Grand mal seizures and Jacksonian seizures well controlled since starting medication at 14 years old).  The patient's concomitant medications included Trileptal (oxcarbazepine) and Depakote (valproate semisodium); the both were indicated for epilepsy.  On an unspecified date, the patient was administered Flu vaccine [influenza vaccine, dose, route of administration, anatomical location, batch number, expiration date: not reported] for unknown indication.   On an unspecified date, after vaccination the patient started experiencing flu with no other side effects.  The outcome of the event influenza was not reported by the reporter.  This case is linked to 201904420 and 201904525, concerning the same patient.  Company Comment: The patient experienced influenza on an unspecified date after vaccination with Flu vaccine. Chronology is unclear but plausible. No diagnostic findings were provided. Causality was confounded by therapy with concomitant medications Trileptal (oxcarbazepine) and Depakote (valproate semisodium). Based on provided information, causal role of the suspect product cannot be totally excluded and is assessed as related.; Reporter's Comments: The patient experienced influenza on an unspecified date after vaccination with Flu vaccine. Chronology is unclear but plausible. No diagnostic findings were provided. Causality was confounded by therapy with concomitant medications Trileptal (oxcarbazepine) and Depakote (valproate semisodium). Based on provided information, causal role of the suspect product cannot be totally excluded and is assessed as related.
Sex: M
Vaccine: UNK
Symptoms: Influenza
Clinical narrative: Flu; This is a spontaneous case initially received from other non-health professional on 28-Aug-2019, concerning a male patient of an unknown age.  The patient's relevant medical history included epilepsy (Grand mal seizures and Jacksonian seizures well controlled since starting medication at 14 years old).  The patient's concomitant medications included Trileptal (oxcarbazepine) and Depakote (valproate semisodium); the both were indicated for epilepsy.  On an unspecified date, the patient was administered Flu vaccine [influenza vaccine, dose, route of administration, anatomical location, batch number, expiration date: not reported] for unknown indication.   On an unspecified date, after vaccination the patient experienced flu with no other side effects.  The outcome of the event Influenza was not reported by the reporter.  This case is linked to 201904420 and 201904524, concerning the same patient.  Company comment: A male patient of unknown age developed influenza after administration of INN Flu Vaccine. Chronology needs more clarification. The patient's concomitant drug (oxcarbazepine) may have contributed in developing this event. With information provided, causality is assessed as related to the product.; Reporter's Comments: A male patient of unknown age developed influenza after administration of INN Flu Vaccine. Chronology needs more clarification. The patient's concomitant drug (oxcarbazepine) may have contributed in developing this event. With information provided, causality is assessed as related to the product.
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Injected limb mobility decreased, Injection site hypoaesthesia, Injection site paraesthesia, Injection site swelling, Musculoskeletal chest pain
Clinical narrative: 09/03/2019 at 1430pm-swelling at injection site, numbness, tingling, threw up x4 on night of 09/03/2019. intense body aches, pain to shoulder, lats, and ribs. stiffness to shoulder, lats and right arm. limited mobilities for right arm.
Age: 16.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Musculoskeletal pain, Musculoskeletal stiffness, Pain, Scar, Vomiting
Clinical narrative: 09/03/2019 at 1430pm-swelling at injection site, numbness, tingling, threw up x4 on night of 09/03/2019. intense body aches, pain to shoulder, lats, and ribs. stiffness to shoulder, lats and right arm. limited mobilities for right arm.
Age: 51.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Insomnia, Pain, Pharyngeal swelling, Swelling face
Clinical narrative: Symptoms began at 4pm; felt achy.  Next day at noon, there was face and throat swelling; felt like throat was collapsing. Went back to vaccine administrator and was told that symptoms had nothing to do with vaccine.  Patient was not told about possible symptoms the day of the vaccination. Patient did not take any medicine, just drank water and went to sleep; patient could barely sleep.  Today, patient took shower and felt dizzy--had to hold on to the sink.  The throat and facial swelling is not as severe as yesterday.  Patient is currently trying to figure out how to follow-up.    Reporter wants to remain anonymous in case we need to contact the facility.
Age: 69.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Chills
Clinical narrative: violent shivering, chills
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Right arm became red, warm to touch over most of the right upper arm. Pt was seen by provider on 9/5/19 at 0930 when she called I about the reaction. Ice today with motrin and Benadryl. If worsens to call back and will start on abx.
Age: 23.0
Sex: F
Vaccine: TYP
Symptoms: Abdominal pain upper, Constipation, Nausea
Clinical narrative: severe stomach cramp, nausea, constipation
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Influenza like illness, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: She received the last dose in the series and about 12 hours after the dose was administered, patient started showing flu-like symptoms. Developed a low grade fever ranging from 100-101, persistent vomiting every 30 minutes, nausea, muscle aches and leg pain. The vomiting stopped after about 12 hours, the nausea and muscle aches lasted 2-3 days. Consulted with pediatrician over the phone and was advised small sips of water and follow-up the next day. As she was improving we were instructed to monitor her and call again if no improvement or worsening. Pediatrician said it was likely viral but nobody else in the household (19 month old and 2 adults) showed any symptoms. My wife and I are both pharmacists and strongly feel this is related to the dose administered. These types of symptoms are listed as possible side effects for 1-10% of patients and other pharmaceutical information software we maintain subscriptions to.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Vomiting
Clinical narrative: She received the last dose in the series and about 12 hours after the dose was administered, patient started showing flu-like symptoms. Developed a low grade fever ranging from 100-101, persistent vomiting every 30 minutes, nausea, muscle aches and leg pain. The vomiting stopped after about 12 hours, the nausea and muscle aches lasted 2-3 days. Consulted with pediatrician over the phone and was advised small sips of water and follow-up the next day. As she was improving we were instructed to monitor her and call again if no improvement or worsening. Pediatrician said it was likely viral but nobody else in the household (19 month old and 2 adults) showed any symptoms. My wife and I are both pharmacists and strongly feel this is related to the dose administered. These types of symptoms are listed as possible side effects for 1-10% of patients and other pharmaceutical information software we maintain subscriptions to.
Age: 64.0
Sex: F
Vaccine: HIBV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: patient received a HIB vaccine instead of a TDAP. She denies any adverse side effects or symptoms. This was discovered by our vaccine champion on 8/30/19 when doing reports. Patient was notified 8/30/19 by the administer of the vaccine. Patient came back into the office on 8/30/19 and received the correct TDaP vaccine.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: While I was doing my monthly reconciliation on 9/3/19 I noticed a Menactra with an expiration date of 08/27/2019 had been given on 08/30/2019 I contacted the CDC and was told the vaccine was not viable and the patient would have to be revaccinated. I spoke with and emailed my Field Rep with details of the incident. I spoke with the patients mother and explained the situation to her. I informed the mother that her daughter would have to be revaccinated. The mother stated she would bring her daughter in for another Menactra.
Age: 0.83
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Muscle spasms, Tremor
Clinical narrative: Mom said child began having tremors + spasms like seizures around 4:30 pm on 9/3/19. Says she took child to 3 emergency rooms in area + they could not see child for hours so they (the family) left all ER's. No treatment received. Came to our office on 9/4 @ 1500ish + child was spasm free + exam unremarkable.
Age: 81.0
Sex: M
Vaccine: UNK
Symptoms: Burning sensation, Injection site pain, Pain in extremity, Vaccination site swelling
Clinical narrative: Sharp pain in entire right arm, arm swollen at vaccine shot area, sharp pain in right shoulder, little finger of left arm felt like it was burning in fire. Continued for almost one full week. Little finger of left hand still burns for short time (5-10 seconds) each day including 8-27-19. Dr. called me at home when he heard I had a bad reaction to the shingle shot. He seemed surprised at first. Told me to forget about taking the second shot in a couple of months.   I do not recall ever having a severe reaction to any vaccine in my life. This was the first time.
Age: 33.0
Sex: F
Vaccine: JEV1
Symptoms: Asthenia, Dysphagia, Dyspnoea, Pruritus, Throat irritation
Clinical narrative: reported some minimal pruritis approximately 10 minutes after the Ixiaro vaccine was administered, and then she reported it "quickly went away." Per client, after about 45 minutes, she began to feel "low energy" and "shaky." She began to have some shortness of breath, burning of throat, and difficulty swallowing. Client then called her mother to pick her up and take her to urgent care for fear the symptoms would progress. Client took Benadryl 25mg and Loratidine 10 mg while at home. Client was seen and assessed at Urgent care; client said they offered to give her a steroid injection but client declined. They continued to assess her and she had no progression of symptoms. She reports this entire reaction resolved within 2-3 hours after first initial onset of symptoms.
Age: 33.0
Sex: F
Vaccine: JEV1
Symptoms: Tremor
Clinical narrative: reported some minimal pruritis approximately 10 minutes after the Ixiaro vaccine was administered, and then she reported it "quickly went away." Per client, after about 45 minutes, she began to feel "low energy" and "shaky." She began to have some shortness of breath, burning of throat, and difficulty swallowing. Client then called her mother to pick her up and take her to urgent care for fear the symptoms would progress. Client took Benadryl 25mg and Loratidine 10 mg while at home. Client was seen and assessed at Urgent care; client said they offered to give her a steroid injection but client declined. They continued to assess her and she had no progression of symptoms. She reports this entire reaction resolved within 2-3 hours after first initial onset of symptoms.
Age: 1.17
Sex: F
Vaccine: DTAPHEPBIP, DTAPIPVHIB, HEPA, MMR, PNC13, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse reactions noted.  Client received Pentacel and Pediarix at same visit and is doing well.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Grimacing, Tic, Trismus
Clinical narrative: My son had severe facial tics that included prolonged closing of the eyes, grimacing, and uncontrollable jaw movement (opening and then closing  the mouth). These occurred approximately every 15-60 seconds for 3 days. He had a history of mild tics such as eye closing after a long day at school previously, but nothing to the magnitude that he experienced from 8/2/2019-8/4/2019. The tics stopped after 3 days. They were mild on day 4 and stopped by day 5 after the vaccine. They were gone by 8/6/2019.
Age: 27.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Brain natriuretic peptide increased, C-reactive protein increased, Chest discomfort, Chest pain, Dyspnoea
Clinical narrative: He reported that he woke up at 0400 on 04 July 19 with pressure in the center of his chest that increased with deep breaths. Rated pain # 8-9 on scale of 1-10. Pain increased when he took a deep breath while lying on his back, and constant pain when on stomach. He reported SOB, and radiation to his neck. He denied palpitations, diaphoresis and N/V. Never had pain like this before and was diagnosed as having myopericarditis, pos enzymes and EKG changes. He currently reported that he is feeling well, taking meds as directed and will have rare episodes of pain lasting only a couple of minutes
Age: 27.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Electrocardiogram abnormal, Middle insomnia, Myocardial necrosis marker increased, Myocarditis, Neck pain
Clinical narrative: He reported that he woke up at 0400 on 04 July 19 with pressure in the center of his chest that increased with deep breaths. Rated pain # 8-9 on scale of 1-10. Pain increased when he took a deep breath while lying on his back, and constant pain when on stomach. He reported SOB, and radiation to his neck. He denied palpitations, diaphoresis and N/V. Never had pain like this before and was diagnosed as having myopericarditis, pos enzymes and EKG changes. He currently reported that he is feeling well, taking meds as directed and will have rare episodes of pain lasting only a couple of minutes
Age: 27.0
Sex: M
Vaccine: ANTH, JEV1, SMALL
Symptoms: Painful respiration, Red blood cell sedimentation rate increased, Troponin I increased
Clinical narrative: He reported that he woke up at 0400 on 04 July 19 with pressure in the center of his chest that increased with deep breaths. Rated pain # 8-9 on scale of 1-10. Pain increased when he took a deep breath while lying on his back, and constant pain when on stomach. He reported SOB, and radiation to his neck. He denied palpitations, diaphoresis and N/V. Never had pain like this before and was diagnosed as having myopericarditis, pos enzymes and EKG changes. He currently reported that he is feeling well, taking meds as directed and will have rare episodes of pain lasting only a couple of minutes
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: patients experience "more of a burning effect" in the arm; This spontaneous report was received from a nurse via a field representative referring to unspecified number of patients of unknown age and unknown gender. Information about pertinent medical history, drug reactions/allergies and concomitant medication was unknown. The patients' concurrent conditions were not provided.  On unknown dates, the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration unknown) (dose, frequency, lot # and expiration date were not reported) for prophylaxis (reported as routine vaccination).  The nurse reported in the last few months, she had noticed when hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringes were administered to patients, the patients experienced more of a burning effect in the arm then when she used the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vials. It was unknown if treatment was given for the event. The outcome of the event was unknown at the reporting time. The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  This case was determined to be a non-valid case due to no patient identifiers provided.  Follow-up information has been received from the nurse on 21-AUG-2019. The patients' age was added as 11-14 years old. The patients' gender were female. The nurse reported that the patients were increasing complaining of a severe burning sensation when receiving the vaccine from prefilled syringe.  This case was determined to be a valid case due to the patients' gender provided.  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-1909USA001656:
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; The patient received dose of PNEUMOVAX 23 that had been improperly stored; This spontaneous report was received from a nurse concerning a patient of unknown age and gender. No information was provided regarding the patient's pertinent medical history, concurrent conditions or drug reactions/allergies.    On 21-AUG-2019 the patient was vaccinated with an improperly stored dose of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23), lot # S004547, expiration date 12-AUG-2020 for prophylaxis (strength, dose, frequency, route of administration, lot number and expiration date were not reported) (product storage error). The administered dose of the vaccine experienced a temperature excursion of 47F degrees Fahrenheit for 1 hour, as recorded by a data logger. There was no previous temperature excursion.  No adverse effects reported.
Sex: M
Vaccine: HPV9
Symptoms: Injection site pain
Clinical narrative: patients experience "more of a burning effect" in the arm; This spontaneous report was received from a nurse referring to an unspecified number of male patients aged from 11 to 14 years old. Information about pertinent medical history, drug reactions/allergies and concomitant medication was unknown. The patients' concurrent conditions were not provided.  On unknown dates (reported as in the last few months), the patients were vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (route of administration unknown) (dose, frequency, lot # and expiration date were not reported) for prophylaxis (reported as routine vaccination).  The nurse reported in the last few months, she had noticed when hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringes were administered to patients, the patients were increasing complaining of a severe burning sensation in the arm when receiving the vaccine from prefilled syringe than when she used the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vials. It was unknown if treatment was given for the event. The outcome of the event was unknown at the reporting time. The causality assessment between the event and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  This is one of the two reports from the same reporter.; Sender's Comments:  US-009507513-1908USA002987:
Sex: U
Vaccine: HIBV, HIBV, HIBV, HIBV
Symptoms: Antibody test negative, Therapy non-responder
Clinical narrative: no titers present in blood work; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a 2-year-old patient who received Hib (Hiberix) for prophylaxis.   Co-suspect products included Hib (Hiberix) for prophylaxis, Hib (Hiberix) for prophylaxis and Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Hiberix, the 2nd dose of Hiberix, the 3rd dose of Hiberix and the 4th dose of Hiberix. On an unknown date, unknown after receiving Hiberix, Hiberix, Hiberix and Hiberix, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Hiberix, Hiberix, Hiberix and Hiberix.  Additional details were provided as follows: The age at vaccination was not reported. The patient's gender was not known. The patient completed the entire Hiberix series and had completed blood work on an unknown date. It showed no titer for Hiberix was present in patient's blood. The reporter consented to follow up. The reporer did not have any patient information or vaccine information available at the time of reporting and stated that the questionnaire could be sent to her.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site urticaria, Injection site warmth
Clinical narrative: welp covered large portion of patient's outer arm/red welt/welt pain/Swelling; hot to the touch; This case was reported by a pharmacist via call center representative and described the occurrence of injection site wheal in a 56-year-old female patient who received Herpes zoster (Shingrix) (batch number K9M5N, expiry date 7th November 2021) for prophylaxis.   On 20th August 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 25th August 2019, 5 days after receiving Shingrix, the patient experienced injection site wheal and injection site warmth. On an unknown date, the outcome of the injection site wheal was not recovered/not resolved and the outcome of the injection site warmth was unknown.   It was unknown if the reporter considered the injection site wheal and injection site warmth to be related to Shingrix.  Additional details were provided as follows: The patient received a dose of Shingrix in the right deltoid. The patient presented with a welt that covered a large area of the patient's right arm.  Welt described as being between the size of a saucer and dinner plate that took up a large portion on the patient's outer arm.  The welt was approximately 2 inches above the elbow, red, swollen, painful, and hot to the touch. Welt described as uneven and wavy and not smooth.  The pharmacist unsure of welt onset, but certain it did not occur same day as vaccination. The reporter consented to follow up. The pharmacist was the reporter. The pharmacist mentions the patient was not a small person and patient's arm was large, and welt covered large portion of patient's outer arm.
Sex: U
Vaccine: HIBV, HIBV, HIBV, HIBV
Symptoms: Antibody test negative, Therapy non-responder
Clinical narrative: no titers present in blood work; This case was reported by a other health professional via call center representative and described the occurrence of therapy non-responder in a patient who received Hib (Hiberix) for prophylaxis.   Co-suspect products included Hib (Hiberix) for prophylaxis, Hib (Hiberix) for prophylaxis and Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Hiberix, the 2nd dose of Hiberix, the 3rd dose of Hiberix and the 4th dose of Hiberix. On an unknown date, unknown after receiving Hiberix, Hiberix, Hiberix and Hiberix, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.   It was unknown if the reporter considered the therapy non-responder to be related to Hiberix, Hiberix, Hiberix and Hiberix.  Additional details were provided as follows: The age at vaccination was not reported. The health care professional calling to report that patient completed the entire Hiberix series and had blood work completed and showed no titers present in their blood work for the Hiberix. The reporter consented to follow up. The health care professional calling did not have any patient information or vaccine information available. She said you can mail or email her a questionnaire.      Lab Comments: lab test performed on unknown date
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Extra dose administered
Clinical narrative: Extra Dose; This case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 62-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number 53BF4, expiry date unknown) for prophylaxis.   On 26th August 2019, the patient received the 2nd dose of Boostrix. On 26th August 2019, unknown after receiving Boostrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional case details were provided as follows: The patient received 2nd dose of boostrix, which led to extra dose administered. The reporter did not consent to follow up.
Sex: U
Vaccine: DTAPIPV, IPV
Symptoms: Extra dose administered
Clinical narrative: patient receiving IPOL and Quadracel on the same day; Initial information received on 29-Aug-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 5 years old patient who received vaccines DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE [QUADRACEL] and IPV (VERO) [IPOL] and reported that patient receiving Ipol and Quadracel on the same day (extra dose administered).  The patient's past medical history, medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  On 26-Aug-2019, the patient received 3rd dose of suspect 0.5 ml IPV (VERO) lot P1A242M and expiry date: 26-Apr-2019 via subcutaneous route in the right arm.  On 26-Aug-2019, the patient received a dose of suspect 0.5 ml DIPHTHERIA-15/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5) VACCINE lot C5500CA and expiry date: 16-Aug-2020 via intramuscular route in the left arm.  It was a case of actual medication error due to extra dose administered.  It was unknown if the patient had any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.  List of documents held by sender: none.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Decreased activity, Injection site pain
Clinical narrative: Persistent left shoulder pain, limiting activity
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: pain, redness, swelling, itching at the injection site
Age: 60.0
Sex: F
Vaccine: FLUA3
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient should have received Flucelvax instead of Fluad due to age. No adverse events at this time.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: I have pain and difficulty moving my right arm.