chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Ultrasound scan abnormal, Upper-airway cough syndrome, Viral infection
Clinical narrative: inflamed lymph nodes/ lump/ cluster of lymph node; lump in neck; viral reaction; mucous / a lot of thick mucous; stuffed up; post nasal drip; injection site lump; Injection site soreness; This case was reported by a consumer via call center representative and described the occurrence of lymphadenitis in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (with post herpatic neuralgia) and post herpetic neuralgia. Previously administered products included Shingles vaccine (received on an unknown date).   On 28th December 2019, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, 5 weeks after receiving Shingrix, the patient experienced lymphadenitis, local swelling, viral infection, mucus discharge, nasal stuffiness, postnasal drip, injection site lump and injection site pain. The patient was treated with guaifenesin (Mucinex). On an unknown date, the outcome of the lymphadenitis and local swelling were recovering/resolving and the outcome of the viral infection was resolved with sequelae and the outcome of the mucus discharge, nasal stuffiness, injection site lump and injection site pain were recovered/resolved and the outcome of the postnasal drip was unknown.   It was unknown if the reporter considered the lymphadenitis, local swelling, viral infection, mucus discharge, nasal stuffiness, postnasal drip, injection site lump and injection site pain to be related to Shingrix.  Additional details were received as follows: The patient found a lump in her right neck after vaccination. The lump was not in the gland but in front of the gland and below the gland. The patient went to her internist who recommended an ultrasound. The ultrasound showed inflamed lymph nodes and a cluster of lymph nodes and he recommended another ultrasound in a month.   The patient also reported that she had a bit of a reaction to the Shingrix vaccine including a viral reaction with a lot of mucous and she was stuffed up. The patient reported a lot of thick mucous and she took Mucinex and she has since stopped taking it but she still has post nasal drip remaining. The patient also experienced lump and soreness at the injection site. The patient consented to follow up.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Myalgia
Clinical narrative: Headache, chills, muscle ache, tiredness
Age: 16.0
Sex: F
Vaccine: FLU4, MENB, MNQ
Symptoms: Product preparation issue
Clinical narrative: Patient got part of the Menveo vaccine. The MenA Lyophilized conjugate component was mixed with a sterile diluent and administered to the patient. It wasn't until after vaccine was given that it was noticed by another employee. Provider was notified, and patient is currently being contacted by the office to let know she will need to be revaccinated.
Age: 15.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Pallor, Syncope, Vision blurred
Clinical narrative: Gave injection in the left deltoid. Patient tolerated the injection well even commented on how the HPV hurts. Patient then turned very pale and mom started calling her name. Patient then slumped over and was sliding down the chair. I placed my body in between her to stop her from sliding to the floor. After about 5 mins and having her smell the smelling salts, cold washcloth she started to respond and stated it was blurry but she could see and hear.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: site swelling, redness warmth, joint aches, fever to 102 degrees
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: NO Additional adverse effect reported; a patient was administered a dose of improperly stored PROQUAD that was diluted with Merck DILUENT that did not experience a temperature excursion.; This spontaneous report has been received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history was not reported.  On 28-JAN-2020, the patient was administered a dose of improperly stored measles, mumps, rubella and varicella (oka-merck) virus vaccine live (recombinant human albumin (rHA)) (PROQUAD) (lot # S012535 with expiration date: 20-OCT-2020; dose, strength and frequency were not reported) (incorrect product storage) that was diluted with merck sterile diluent (STERILE DILUENT) that did experience a temperature excursion subcutaneously for prophylaxis. No additional adverse effect reported.  The vaccine was stored under -14 Celsius degree to -10 degree (-12.6 degree) for 9 hours and 53 minutes. The previous temperature excursion was -14 degree to -10 degree (-13.00 degree) for 14 hours and 22 minutes. The digital data logger was involved.  This is 1 of 6 reports from the same reporter.; Sender's Comments:  US-009507513-2002USA001459: US-009507513-2002USA001517: US-009507513-2002USA001483: US-009507513-2002USA001480: US-009507513-2002USA001486:
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: pneumonia vaccine (2000 to present (2020)) annually; None side effects; Information received from a case in litigation (MARRS# 1902USA002463) referring to an adult female patient. From 2000 to present (2020), the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (reported as pneumonia vaccine) (dose, route of administration, anatomical location, lot#, expiration date were unknown) annually for prophylaxis (inappropriate schedule of product administration). The patient did not experience side effects.; Sender's Comments:  US-009507513-1902USA002463:
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Anxiety, Asthma, Chills, Condition aggravated
Clinical narrative: chills; felt awful; felt sick to my stomach; tired; Itching at the site; I had a hard time breathing; asthma to flare up; anxiety; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, feeling abnormal, upset stomach, fatigue, injection site itching, difficulty breathing, asthma aggravated and anxiety. On an unknown date, the outcome of the chills, feeling abnormal, upset stomach, fatigue, injection site itching, difficulty breathing, asthma aggravated and anxiety were unknown.   It was unknown if the reporter considered the chills, feeling abnormal, upset stomach, fatigue, injection site itching, difficulty breathing, asthma aggravated and anxiety to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient received Shingrix vaccine and felt awful, sick to stomach tired, chills, Itching at the site, hard time breathing, causing asthma to flare up and it could had been patients anxiety. The patient was not sure if he/she should get the second dose.
Sex: U
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Injection site pruritus
Clinical narrative: chills; felt awful; felt sick to my stomach; tired; Itching at the site; I had a hard time breathing; asthma to flare up; anxiety; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced chills, feeling abnormal, upset stomach, fatigue, injection site itching, difficulty breathing, asthma aggravated and anxiety. On an unknown date, the outcome of the chills, feeling abnormal, upset stomach, fatigue, injection site itching, difficulty breathing, asthma aggravated and anxiety were unknown.   It was unknown if the reporter considered the chills, feeling abnormal, upset stomach, fatigue, injection site itching, difficulty breathing, asthma aggravated and anxiety to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient received Shingrix vaccine and felt awful, sick to stomach tired, chills, Itching at the site, hard time breathing, causing asthma to flare up and it could had been patients anxiety. The patient was not sure if he/she should get the second dose.
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue
Clinical narrative: fatigue; shortness of breath; This case was reported by a other health professional via sales rep and described the occurrence of fatigue in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced fatigue and shortness of breath. On an unknown date, the outcome of the fatigue and shortness of breath were recovered/resolved.   It was unknown if the reporter considered the fatigue and shortness of breath to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient experienced fatigue and shortness of breath for 1 weeks. No other information was reported.
Age: 4.0
Sex: M
Vaccine: HIBV, HIBV
Symptoms: Product preparation error
Clinical narrative: Hiberix vaccine reconstituted with a MMR diluent; Wrong solution used in drug reconstitution; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate preparation of medication in a 4-year-old male patient who received Hib (Hiberix) (batch number X29YB, expiry date 3rd November 2020) and (batch number S031904, expiry date 19th June 2022) for prophylaxis.   On 6th February 2020, the patient received Hiberix. On an unknown date, the dose was an unknown dose. On 6th February 2020, unknown after receiving Hiberix, the patient experienced inappropriate preparation of medication and wrong solution used in drug reconstitution. On an unknown date, the outcome of the inappropriate preparation of medication and wrong solution used in drug reconstitution were unknown.  Additional details were reported as follows: The reporter stated that the Hiberix vaccine reconstituted with a MMR diluent and administered to patient, which led to inappropriate preparation of medication and wrong solution used in drug reconstitution.
Sex: U
Vaccine: VARZOS
Symptoms: Muscle tightness, Pain
Clinical narrative: Aches and pains; Muscle tightness; This case was reported by a consumer via call center representative and described the occurrence of pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced pain and muscle tightness. On an unknown date, the outcome of the pain and muscle tightness were unknown.   It was unknown if the reporter considered the pain and muscle tightness 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 side effects like aches and pains muscle tightness. The patient asked, how long do the side effects last with the shingles vaccine. The reporter did not consent to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Dizziness, Extrasystoles, Heart rate increased, Nausea
Clinical narrative: pain in stomach / pit in stomach; Dizziness; Nausea; Vomiting; cardiac issues that lasted for approximately 1.5 hours heart rate was really fast; Heart skipping beats; Heart pounding; soreness in arm; pulse was trickety; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 7th February 2020, the patient experienced stomach pain, dizziness, nausea, vomiting, heart rate increased, heartbeats skipped, pulse abnormal and heart pounding. On 7th February 2020, the outcome of the dizziness, nausea, vomiting, heart rate increased and heartbeats skipped were recovered/resolved. On 9th February 2020, the outcome of the stomach pain was recovered/resolved. On an unknown date, the outcome of the pain in arm, pulse abnormal and heart pounding were recovered/resolved.   It was unknown if the reporter considered the pain in arm, stomach pain, dizziness, nausea, vomiting, heart rate increased, heartbeats skipped, pulse abnormal and heart pounding to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and had soreness in arm that evening.  The patient wakes up early with pain in stomach described as a feeling of eating something that may have set too long. The caller also described feeling like a pit in stomach. Stomach pain reportedly lasting throughout the weekend. The caller reported drinking a little coffee but the stomach pain became worse.  The patient had dizziness, followed by nausea, and then vomiting.  The caller reported vomiting cleared everything out, and dizziness, nausea and vomiting resolved. The consumer then reported cardiac issues that lasted for approximately 1.5 hours heart rate was fast, pounding, skipping beats, and pulse was trickety. All symptoms had already resolved and one would be unable to tell the reactions she experienced.  The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Palpitations, Pulse abnormal, Vomiting
Clinical narrative: pain in stomach / pit in stomach; Dizziness; Nausea; Vomiting; cardiac issues that lasted for approximately 1.5 hours heart rate was really fast; Heart skipping beats; Heart pounding; soreness in arm; pulse was trickety; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 56-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 6th February 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 7th February 2020, the patient experienced stomach pain, dizziness, nausea, vomiting, heart rate increased, heartbeats skipped, pulse abnormal and heart pounding. On 7th February 2020, the outcome of the dizziness, nausea, vomiting, heart rate increased and heartbeats skipped were recovered/resolved. On 9th February 2020, the outcome of the stomach pain was recovered/resolved. On an unknown date, the outcome of the pain in arm, pulse abnormal and heart pounding were recovered/resolved.   It was unknown if the reporter considered the pain in arm, stomach pain, dizziness, nausea, vomiting, heart rate increased, heartbeats skipped, pulse abnormal and heart pounding to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and had soreness in arm that evening.  The patient wakes up early with pain in stomach described as a feeling of eating something that may have set too long. The caller also described feeling like a pit in stomach. Stomach pain reportedly lasting throughout the weekend. The caller reported drinking a little coffee but the stomach pain became worse.  The patient had dizziness, followed by nausea, and then vomiting.  The caller reported vomiting cleared everything out, and dizziness, nausea and vomiting resolved. The consumer then reported cardiac issues that lasted for approximately 1.5 hours heart rate was fast, pounding, skipping beats, and pulse was trickety. All symptoms had already resolved and one would be unable to tell the reactions she experienced.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Eosinophil count increased
Clinical narrative: increased eosinophilic levels; This case was reported by a pharmacist via call center representative and described the occurrence of blood eosinophils increased in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced blood eosinophils increased. On an unknown date, the outcome of the blood eosinophils increased was unknown.   It was unknown if the reporter considered the blood eosinophils increased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication.  The patient received a dose of Shingrix vaccine and patient had increased eosinophilic levels. No further details were provided.
Sex: U
Vaccine: MNQ
Symptoms: Intercepted product administration error, Product complaint
Clinical narrative: chance that a low-filled dose of Menveo could be administered to a patient; Menveo vial (liquid conjugate vial) that was empty out of the carton; Menveo vial (liquid conjugate vial) that was empty out of the carton; This case was reported by a nurse via sales rep and described the occurrence of intercepted drug administration error in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient received Menveo (intramuscular). On an unknown date, unknown after receiving Menveo, the patient experienced intercepted drug administration error, manufacturing issue and pharmaceutical product complaint. On an unknown date, the outcome of the intercepted drug administration error, manufacturing issue and pharmaceutical product complaint were unknown.  Additional details were received as follows: The age at vaccination was not applicable for this report. The reporter stated that one of the nurses at the clinic reported the following regarding two vials that came from the same carton in which one Menveo vial (liquid conjugate vial) that was empty out of the carton and there was no evidence of leaking into the carton, however she does not know if there was a crack in the vial or if the rubber stopper was pierced. One Menveo vial with a low fill and nurse said she was able to withdraw .25 or .3 ml after reconstitution. The syringe used was a 3 ml syringe with hashmarks marked for a quarter of a ml. The LPN stated that she has experienced a low fill volume before about a year ago and that product was discarded, which led to intercepted drug administration error, manufacturing issue and pharmaceutical product complaint. LPN does not know if air was injected into the vial, and stated no cracks or leaks were reported in the vial. LPN stated that there was a scant amount of liquid in the liquid conjugate vial, but nothing in the powder vial. LPN stated that the nurse "tried several times to get a larger volume out of the reconstituted vial, but was not able to get more than .25 to 3ml.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise
Clinical narrative: Sick with flu-like symptoms; Sick; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced influenza-like symptoms and sickness. On an unknown date, the outcome of the influenza-like symptoms and sickness were recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms and sickness to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's family member. The age at vaccination was not reported. The patient was sick with flu like symptoms for 1 week. The caller declined to provide further information. For tolerances of 2nd dose refer case US2020AMR025580, reported by same reporter for the same patient.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Gastrointestinal disorder, Headache
Clinical narrative: sick; she feels like she has the flu; weak; tired; headache; shivering; gastrointestinal symptoms; myalgia; nauseated; doesn't feel well; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date and had no side effects).   On 11th February 2020, the patient received the 2nd dose of Shingrix. On 12th February 2020, 1 days after receiving Shingrix, the patient experienced sickness, influenza like illness, weakness, tiredness, headache, shivering, gastrointestinal symptom nos, myalgia, nausea and feeling unwell. On an unknown date, the outcome of the sickness, influenza like illness, weakness, tiredness, headache, shivering, gastrointestinal symptom nos, myalgia and nausea were not recovered/not resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the sickness, influenza like illness, weakness, tiredness, headache, shivering, gastrointestinal symptom nos, myalgia, nausea and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and she did not feel well at all and she claims that the product made her sick.  She reported that she got up this morning and she feels like she has the flu and she is weak, tired, has a headache, shivering but no fever. She feels bad with gastrointestinal symptoms, nausea and myalgia. No additional details were available. The reporter consented to follow up. This case linked with US2020AMR025607, reported by same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Malaise, Myalgia, Nausea
Clinical narrative: sick; she feels like she has the flu; weak; tired; headache; shivering; gastrointestinal symptoms; myalgia; nauseated; doesn't feel well; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on unknown date and had no side effects).   On 11th February 2020, the patient received the 2nd dose of Shingrix. On 12th February 2020, 1 days after receiving Shingrix, the patient experienced sickness, influenza like illness, weakness, tiredness, headache, shivering, gastrointestinal symptom nos, myalgia, nausea and feeling unwell. On an unknown date, the outcome of the sickness, influenza like illness, weakness, tiredness, headache, shivering, gastrointestinal symptom nos, myalgia and nausea were not recovered/not resolved and the outcome of the feeling unwell was unknown.   It was unknown if the reporter considered the sickness, influenza like illness, weakness, tiredness, headache, shivering, gastrointestinal symptom nos, myalgia, nausea and feeling unwell to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and she did not feel well at all and she claims that the product made her sick.  She reported that she got up this morning and she feels like she has the flu and she is weak, tired, has a headache, shivering but no fever. She feels bad with gastrointestinal symptoms, nausea and myalgia. No additional details were available. The reporter consented to follow up. This case linked with US2020AMR025607, reported by same reporter.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Rash
Clinical narrative: the area got very hard and grew quickly; light rash; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number K2397, expiry date 17th December 2021) for prophylaxis.   Concurrent medical conditions included rash.   On 11th January 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 11th January 2020, less than a day after receiving Shingrix, the patient experienced induration. In January 2020, the patient experienced rash. On an unknown date, the outcome of the rash was recovering/resolving and the outcome of the induration was unknown.   It was unknown if the reporter considered the rash and induration to be related to Shingrix.  Additional details were provided as follows:  The patient experienced a light rash for months under the area where she received her 2nd dose of Shingrix. The patient experienced the area got very hard and grew quickly and now covers most of her upper arm where she received Shingrix.
Sex: U
Vaccine: MENB
Symptoms: Seizure
Clinical narrative: seizure; This case was reported by a other health professional via sales rep and described the occurrence of seizure in an unspecified number of patients who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, unknown after receiving Bexsero, the patient experienced seizure (serious criteria GSK medically significant). On an unknown date, the outcome of the seizure was unknown.   It was unknown if the reporter considered the seizure to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The medical assistant reported that a physician in another office informed the physician at her office that they had experienced cases of seizure after the administration of Bexsero. The other physician at her office was switching to Trumenba because the physician at her office trusts the physician who reported the cases of seizures.  The reporter did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: Bad case of Shingles - neck, back of head and shoulder - right side of body.  Terrible nerve pain on head.  Treatment - Valacyclovir HCL 1 gram                             Advil
Age: 92.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: Patient and his son arrived to the pharmacy on 2/19/20 for second dose of Shingrix. They stated the patient developed hives and severe itching on his right shoulder/back after receiving the first dose on 10/02/19. They were unsure of the time of onset, but stated symptoms lasted over one month. Patient picked up topical steroid for treatment on 10/08/19, which he stated provided minimal relief.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Syncope
Clinical narrative: The day after the shot, my arm ached, I was nauseous and fainted. I fainted again day 2 after the shot. After that, I was fine.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Vertigo
Clinical narrative: Pt states she had really bad nausea all night beginning early on 2/21/2020 and vertigo when she went to get up this morning.  States she was still lying down when she called the pharmacy today around 9:45am because she is scared to get up.  Recommended she call a family member and go to her physician or urgent care for follow-up.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site pruritus
Clinical narrative: Rectangular red area on my left arm around the injection site which is slightly itchy, flu-like symptoms (achy)
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Urticaria
Clinical narrative: Two days after vaccine administration, the patient developed facial hives from her chin to her ear on the right side of her face only.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Injection site pain, Loss of personal independence in daily activities, Malaise
Clinical narrative: Fever up to 101.0F, body aches, general malaise, shivering, headache, nausea, pain at injection site.  Symptoms began in the afternoon after morning administration and lasted for 3 days. Fever subsided on morning of day 3. This resulted in my missing 2 days of work due to the above symptoms.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain, Pyrexia
Clinical narrative: Fever up to 101.0F, body aches, general malaise, shivering, headache, nausea, pain at injection site.  Symptoms began in the afternoon after morning administration and lasted for 3 days. Fever subsided on morning of day 3. This resulted in my missing 2 days of work due to the above symptoms.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Rash papular, Rash vesicular
Clinical narrative: 3x6 cm raised, hives-like rash on her (R) upper deltoid region where she had her shot 2 days ago. No symptoms of anaphylaxis or other complications.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, FLU4, HIBV, PNC13, RV5
Symptoms: Rash, Skin warm
Clinical narrative: patient developed rash on legs and arms the same night as the vaccines, rash is warm to touch
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site urticaria
Clinical narrative: Three-inch welt at site of inoculation Shivering for 16 hours
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered
Clinical narrative: did not experience any symptoms; was inadvertently administered one dose each of Proquad and Varivax/that the patient was meant to be given MMR II and Varivax; was inadvertently administered one dose each of Proquad and Varivax/that the patient was meant to be given MMR II and Varivax; was inadvertently administered one dose each of Proquad and Varivax/that the patient was meant to be given MMR II and Varivax; This spontaneous report as received from a physician refers to a 5-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.   On 04-FEB-2020 (reported as "today"), the patient was inadvertently vaccinated with one dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) (exact dose, route of administration, lot # and expiration date were not provided) and one dose of varicella virus vaccine live (oka/merck) (VARIVAX) (exact dose, route of administration, lot # and expiration date were not provided) instead of being vaccinated with and varicella virus vaccine live (oka/merck) (VARIVAX) and measles, mumps, and rubella (wistar RA 27-3) virus vaccine, live (M-M-R II) (dose, route of administration, lot # and expiration date were not reported).
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: fever; This spontaneous report was received from a lawyer, regarding a case in litigation for zoster vaccine live (ZOSTAVAX) (# US-009507513-1704USA010973), and refers to female patient of unknown age. The patient smoked cigarettes for 15 years. Her concurrent conditions included chronic obstructive pulmonary disease (COPD), methicillin-resistant Staphylococcus aureus (MRSA) and emphysema. The patient's medical history included chickenpox and shingles. On an unknown date in 2016, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (dose, route of administration, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient got fever. The outcome of the event was unknown. The relatedness between the event and pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) was not provided. This is one of two cases concerning the same patient.; Sender's Comments:  US-009507513-1704USA010973:
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration
Clinical narrative: the patient received a dose of MMR II via the intramuscular route on 2/18/2020; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 18-FEB-2020, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II), intramuscularly (dose, lot # and expiration date were not reported), for prophylaxis (Inappropriate route of vaccination). Concomitant therapies included sterile diluent. The outcome of the event was unknown.
Age: 1.17
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effects reported; a patient was administered improperly stored PEDVAXHIB; This spontaneous report was received from a nurse and refers to a 14-month-old patient of unknown gender. No information regarding the patient's concurrent conditions, medical history and concomitant medications was provided.  On 20-DEC-2019, the patient was vaccinated with improperly stored haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) lot # R027329, expiration date 12-JUL-2021 (dose, route and site of administration were not provided) for prophylaxis. The administered vaccine experienced multiple temperature excursion 0.3 Celsius degrees below 2 Celsius degrees for 45 minutes. There was no previous temperature excursion. Data logger was involved. No additional adverse effects were reported.
Sex: U
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue
Clinical narrative: How long does fatigue and upset stomach last?; still felling fatigued; This case was reported by a consumer via call center representative and described the occurrence of upset stomach in a 77-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 8th February 2020, the patient received Shingrix. In February 2020, less than a week after receiving Shingrix, the patient experienced upset stomach and fatigue. On an unknown date, the outcome of the upset stomach and fatigue were not recovered/not resolved.   It was unknown if the reporter considered the upset stomach and fatigue to be related to Shingrix.  Additional details were provided as follows: The age at vaccination not provided but it could be 76 or 77 years. The patient received Shingrix and experienced fatigue and upset stomach. The reporter enquired that how long did the fatigue and upset stomach last. The patient had a shot on Saturday and patient still felling fatigued.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Headache, Oxygen saturation decreased, Pain, Pyrexia
Clinical narrative: horrible headache; Body ache; shivering; fever; oxygen was very low; This case was reported by a consumer via call center representative and described the occurrence of headache in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th February 2020, the patient received Shingrix. On 11th February 2020, 1 days after receiving Shingrix, the patient experienced headache, general body pain, shivering, fever and oxygen saturation decreased. On an unknown date, the outcome of the headache was not recovered/not resolved and the outcome of the general body pain, shivering, fever and oxygen saturation decreased were unknown.   It was unknown if the reporter considered the headache, general body pain, shivering, fever and oxygen saturation decreased to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient for self. The age at vaccination was not reported. The patient received Shingrix vaccine and experienced horrible headache, body ache, shivering and fever. The patient had a doctor appointment for another issue and oxygen was very low. The patient wanted to know the events were normal. Till the time of reporting the patient had headache.
Sex: U
Vaccine: VARZOS
Symptoms: Facial pain, Feeling abnormal, Headache, Oral pain, Pain
Clinical narrative: felt like I was hit by a bus; ache started in my mouth; ache started in my mouth, then face; ache started in my mouth, then face, head; ache started in my mouth, then face, head, and the rest of my body.; pain starting in my lower right jaw is extremely painful; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th February 2020, the patient received Shingrix. On 11th February 2020, 1 days after receiving Shingrix, the patient experienced feeling abnormal, oral pain, facial pain, headache, general body pain and jaw pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the feeling abnormal, oral pain, facial pain, headache, general body pain and jaw pain were unknown.   It was unknown if the reporter considered the feeling abnormal, oral pain, facial pain, headache, general body pain and jaw pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for self. The age at vaccination was not reported. The patient received shingrix vaccine and next day felt like hit by a bus. The patient also experienced ache which was started in mouth, then face, head and rest of the body. The patient took lots of Tylenol and woke up during the night needing more tylenol. The patient stated that pain was started in mouth first where it hurts the worse. The patient stated that sudden pain that started in lower right jaw was extremely painful. At the time of reporting patient felt better but worried about the time when tylenol wore off. The patient's last dentel exam was less than 2 months ago from reporting date and there were no issues. The patient wanted to know whether pain in jaw was one of the side effect of vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in jaw
Clinical narrative: felt like I was hit by a bus; ache started in my mouth; ache started in my mouth, then face; ache started in my mouth, then face, head; ache started in my mouth, then face, head, and the rest of my body.; pain starting in my lower right jaw is extremely painful; This case was reported by a consumer via call center representative and described the occurrence of feeling abnormal in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th February 2020, the patient received Shingrix. On 11th February 2020, 1 days after receiving Shingrix, the patient experienced feeling abnormal, oral pain, facial pain, headache, general body pain and jaw pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the feeling abnormal, oral pain, facial pain, headache, general body pain and jaw pain were unknown.   It was unknown if the reporter considered the feeling abnormal, oral pain, facial pain, headache, general body pain and jaw pain to be related to Shingrix.  Additional details were reported as follows: This case was reported by patient for self. The age at vaccination was not reported. The patient received shingrix vaccine and next day felt like hit by a bus. The patient also experienced ache which was started in mouth, then face, head and rest of the body. The patient took lots of Tylenol and woke up during the night needing more tylenol. The patient stated that pain was started in mouth first where it hurts the worse. The patient stated that sudden pain that started in lower right jaw was extremely painful. At the time of reporting patient felt better but worried about the time when tylenol wore off. The patient's last dentel exam was less than 2 months ago from reporting date and there were no issues. The patient wanted to know whether pain in jaw was one of the side effect of vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Headache, Neck pain
Clinical narrative: neck pain; head pain; This case was reported by a other health professional via interactive digital media and described the occurrence of neck pain in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, unknown after receiving Shingrix, the patient experienced neck pain and headache. On an unknown date, the outcome of the neck pain and headache were unknown.   It was unknown if the reporter considered the neck pain and headache to be related to Shingrix.  Additional details were received as follows: The age at vaccination was not reported. The age group was not reported, but was selected adult as per vaccine indication. The patient experienced severe neck and head pain.
Sex: M
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Acne, Condition aggravated, Eczema, Herpes zoster, Oral herpes
Clinical narrative: Shingles; Cold sore on lip; "Festering under skin like pimple"; Acne on shoulder; Exacerbation of eczema; Skin is tender; Itch; Rash/ Pain with rash; Pain with rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eczema.   In January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th January 2020, 2 weeks after receiving Shingrix, the patient experienced pruritus, rash, pain, skin tenderness and eczema aggravated. On an unknown date, the patient experienced shingles, cold sores lip, subcutaneous abscess and acne. The patient was treated with steroids nos (Steroids). On 11th February 2020, the outcome of the cold sores lip, pruritus, rash, pain, subcutaneous abscess, skin tenderness, acne and eczema aggravated were recovered/resolved. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles, cold sores lip, pruritus, rash, pain, subcutaneous abscess, skin tenderness, acne and eczema aggravated to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. This case was reported by patient himself. The patient received first dose of Shingrix sometime in mid January. The patient reported that about 2 weeks later he started developing symptoms of what he thinks was Shingles. The patient went to the emergency room and received steroid cream to treat affected areas. The patient expereinced itch, rash, pain, festering under his skin like a pimple, tender skin on affected areas, cold sore on his lip, acne on his shoulder and exacerbation of his eczema. The patient was being treated by his health care professional. Provided him with phone number for Medical Information department so his health care professional can call for further information. The reporter consented to follow up. Emergency visit required.
Sex: M
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Pain, Pain of skin, Pruritus, Rash, Subcutaneous abscess
Clinical narrative: Shingles; Cold sore on lip; "Festering under skin like pimple"; Acne on shoulder; Exacerbation of eczema; Skin is tender; Itch; Rash/ Pain with rash; Pain with rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eczema.   In January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th January 2020, 2 weeks after receiving Shingrix, the patient experienced pruritus, rash, pain, skin tenderness and eczema aggravated. On an unknown date, the patient experienced shingles, cold sores lip, subcutaneous abscess and acne. The patient was treated with steroids nos (Steroids). On 11th February 2020, the outcome of the cold sores lip, pruritus, rash, pain, subcutaneous abscess, skin tenderness, acne and eczema aggravated were recovered/resolved. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles, cold sores lip, pruritus, rash, pain, subcutaneous abscess, skin tenderness, acne and eczema aggravated to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. This case was reported by patient himself. The patient received first dose of Shingrix sometime in mid January. The patient reported that about 2 weeks later he started developing symptoms of what he thinks was Shingles. The patient went to the emergency room and received steroid cream to treat affected areas. The patient expereinced itch, rash, pain, festering under his skin like a pimple, tender skin on affected areas, cold sore on his lip, acne on his shoulder and exacerbation of his eczema. The patient was being treated by his health care professional. Provided him with phone number for Medical Information department so his health care professional can call for further information. The reporter consented to follow up. Emergency visit required.
Sex: M
Vaccine: VARZOS, UNK, VARZOS
Symptoms: Myalgia, Rash erythematous, Rash pruritic
Clinical narrative: Shingles; Cold sore on lip; "Festering under skin like pimple"; Acne on shoulder; Exacerbation of eczema; Skin is tender; Itch; Rash/ Pain with rash; Pain with rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included eczema.   In January 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th January 2020, 2 weeks after receiving Shingrix, the patient experienced pruritus, rash, pain, skin tenderness and eczema aggravated. On an unknown date, the patient experienced shingles, cold sores lip, subcutaneous abscess and acne. The patient was treated with steroids nos (Steroids). On 11th February 2020, the outcome of the cold sores lip, pruritus, rash, pain, subcutaneous abscess, skin tenderness, acne and eczema aggravated were recovered/resolved. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles, cold sores lip, pruritus, rash, pain, subcutaneous abscess, skin tenderness, acne and eczema aggravated to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. This case was reported by patient himself. The patient received first dose of Shingrix sometime in mid January. The patient reported that about 2 weeks later he started developing symptoms of what he thinks was Shingles. The patient went to the emergency room and received steroid cream to treat affected areas. The patient expereinced itch, rash, pain, festering under his skin like a pimple, tender skin on affected areas, cold sore on his lip, acne on his shoulder and exacerbation of his eczema. The patient was being treated by his health care professional. Provided him with phone number for Medical Information department so his health care professional can call for further information. The reporter consented to follow up. Emergency visit required.