chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV, UNK
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effects reported; patient received PROQUAD which was administered with expired DILUENT MRK INJ; This spontaneous report as received from a physician refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On 13-MAR-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live, rHA (PROQUAD) lot # R015742, expiration date 02-DEC-2019 (dose and route of administration were not provided), which was administered with expired sterile diluent, lot number L028663 (dose, route of administration and expiration date were not provided), for prophylaxis. No adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms 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 influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced heavy flu like symptoms after 1st dose of Shingrix. This case linked with US2019AMR119306, reported by same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Vaccine positive rechallenge
Clinical narrative: Fatigue; myalgia; headache; This case was reported by a nurse via sales rep and described the occurrence of fatigue in a 54-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of fatigue (1st dose, refer case US2019AMR128716).   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced fatigue, myalgia and headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the fatigue, myalgia and headache were recovered/resolved.   The reporter considered the fatigue, myalgia and headache to be related to Shingrix.  Additional details were provided as follows: This case was reported by the patient's wife who herself was a Nurse. Approximately 8 months before the date of reporting, the patient received a dose of Shingrix at his primary care location. Fatigue, myalgia abd headache were lasted approximately for one day. The reporter said that prior to receiving the vaccine she told the patient that the side effects could be expected from many vaccines, including Shingrix and did attribute the side effects to vaccination. The reporter did not agree for follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site pain, Pain
Clinical narrative: injection site pain; flu like; tired; achy; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 72-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 2 days after receiving Shingrix, the patient experienced injection site pain, influenza like illness, tiredness and pain. On an unknown date, the outcome of the injection site pain, influenza like illness, tiredness and pain were unknown.   It was unknown if the reporter considered the injection site pain, influenza like illness, tiredness and pain to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. In 2019, 2 months ago from the reporting date, the patient received 1st dose of Shingrix and was reluctant to take 2nd dose of Shingrix just after 2 months. The patient asked whether it was more ideal to wait 4 to 5 months between doses. The patient told that since availability was not an issue and asked whether there are more reactions. The reporter asked if the doses were given after 2 months than 5 to 6 months. The reporter was told that the 2nd dose of Shingrix was recommended to be received between 2 to 6 months after receiving the vaccine, for further assistance they could direct the chat to a Shingrix product specialist. The patient experienced pain at injection site and flu like. On the 2nd day, the patient experienced minimum reaction like very tired and generally achy.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Rash
Clinical narrative: injection site redness; Mild swelling around injection site; Arm rash; This case was reported by a nurse via sales rep and described the occurrence of injection site erythema in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced injection site erythema, injection site swelling and rash. On an unknown date, the outcome of the injection site erythema, injection site swelling and rash were unknown.   It was unknown if the reporter considered the injection site erythema, injection site swelling and rash to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient experienced redness and mild swelling around the injection site but then he also developed a rash that extended from the injection site down past his elbow.
Age: 56.0
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Pyrexia
Clinical narrative: fever; chills; headache; tiredness; This case was reported by a consumer and described the occurrence of fever in a 56-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th July 2019, the patient received the 2nd dose of Shingrix. On 17th July 2019, 1 days after receiving Shingrix, the patient experienced fever, chills, headache and tiredness. On an unknown date, the outcome of the fever, chills, headache and tiredness were unknown.   It was unknown if the reporter considered the fever, chills, headache and tiredness to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and experienced fever, chills, headache and tiredness. The patient inquired, how long do the side effects would last.
Age: 84.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: shingles; inappropriate schedule of vaccine; This case was reported by a nurse and described the occurrence of shingles in a 84-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not applicable for the 2nd dose. The patient received Shingrix vaccine about 8months ago, however never follow up with the 2nd portion of the vaccination series. He came into clinic at the time of reporting with what appears to be the shingles.  The reporter reported that could this be possible given the vaccine wasn't live and should he get the 2nd portion of the series, even though he was beyond the 2-6 month time interval, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Nasopharyngitis, Rhinorrhoea
Clinical narrative: Minor cold; Runny nose; sneezing; Injection site pain; Injection site redness; Injection site swelling; This case was reported by a consumer via call center representative and described the occurrence of cold symptoms in a elderly 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, 7 days after receiving Shingrix, the patient experienced cold symptoms, runny nose, sneezing, injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the cold symptoms, runny nose, sneezing, injection site pain, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the cold symptoms, runny nose, sneezing, injection site pain, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that a week after the 2nd shingles shot had a symptoms of a very minor cold, runny nose, sneezing. The patient was asking whether the events are related to the vaccine. The GSK reporter recommended patient to speak with the healthcare provider regarding the events. They stated that the healthcare provider will determine the right treatment plan. The patient also had the pain, redness and swelling with the 2nd shot. This case has been linked with US2019AMR131628, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Sneezing
Clinical narrative: Minor cold; Runny nose; sneezing; Injection site pain; Injection site redness; Injection site swelling; This case was reported by a consumer via call center representative and described the occurrence of cold symptoms in a elderly 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, 7 days after receiving Shingrix, the patient experienced cold symptoms, runny nose, sneezing, injection site pain, injection site erythema and injection site swelling. On an unknown date, the outcome of the cold symptoms, runny nose, sneezing, injection site pain, injection site erythema and injection site swelling were unknown.   It was unknown if the reporter considered the cold symptoms, runny nose, sneezing, injection site pain, injection site erythema and injection site swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient stated that a week after the 2nd shingles shot had a symptoms of a very minor cold, runny nose, sneezing. The patient was asking whether the events are related to the vaccine. The GSK reporter recommended patient to speak with the healthcare provider regarding the events. They stated that the healthcare provider will determine the right treatment plan. The patient also had the pain, redness and swelling with the 2nd shot. This case has been linked with US2019AMR131628, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pain
Clinical narrative: Soreness at injection site; Fever; Chills; Overall aches; Headache; Fatigue; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain, fever, chills, pain, headache and fatigue. On an unknown date, the outcome of the injection site pain, fever, chills, pain, headache and fatigue were unknown.   It was unknown if the reporter considered the injection site pain, fever, chills, pain, headache and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had first 24 hours soreness at injection sight. The 24 hours later fever, chills, overall aches, headache and fatigue. The patient continued with very sore at injection site. The reporter did not gave permission to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Soreness at injection site; Fever; Chills; Overall aches; Headache; Fatigue; This case was reported by a consumer and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced injection site pain, fever, chills, pain, headache and fatigue. On an unknown date, the outcome of the injection site pain, fever, chills, pain, headache and fatigue were unknown.   It was unknown if the reporter considered the injection site pain, fever, chills, pain, headache and fatigue to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had first 24 hours soreness at injection sight. The 24 hours later fever, chills, overall aches, headache and fatigue. The patient continued with very sore at injection site. The reporter did not gave permission to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity, Injection site rash, Musculoskeletal stiffness, Pyrexia, Rash
Clinical narrative: Rash on upper arm; Allergy; Neck Stiffness; Fever; This case was reported by a pharmacist via sales rep and described the occurrence of rash in a 69-year-old female patient who received Herpes zoster (Shingrix) (batch number 47JA3, expiry date 12th May 2020) for prophylaxis.   Concurrent medical conditions included type ii diabetes mellitus and diabetic polyneuropathy (without long term current use of insulin). Concomitant products included insulin nos (Insulin).   On 27th June 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 27th June 2019, less than a day after receiving Shingrix, the patient experienced stiff neck and fever. On 2nd July 2019, the patient experienced rash and allergy. On 29th June 2019, the outcome of the stiff neck was recovered/resolved. On an unknown date, the outcome of the rash, fever and allergy were not recovered/not resolved.   It was unknown if the reporter considered the rash, stiff neck, fever and allergy to be related to Shingrix.  Additional information was provided as follows: The patient received Shingrix vaccine in left arm. The patient received Shingrix and arrived to physician's office on 2nd July 2019 with a rash surrounding left upper arm due to allergy. The patient also experienced neck stiffness for 48 hours post injection and having fever. Pharmacy and physician's office in same building and they were able to communicate regarding patient's adverse event.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: arm soreness; tiredness; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (the patient experienced 4 to 5 shingles outbreaks in 2018) and scar (the patient had scars from her previous shingles). Previously administered products included Zostavax.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved.   It was unknown if the reporter considered the pain in arm and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received her 1st dose of Shingrix 6 months ago and experienced arm soreness and tiredness. The patient declined to provide her name and contact information. The case was linked to the case US2019AMR130538 reported by same reporter for same patient (2nd dose). There was discrepancy in age group reported in source document (infant) and it was reported as adult. The age group kept as adult as reported.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: injection site soreness; Injection site redness; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in an unspecified number of adult patients 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 injection site pain and injection site erythema. On an unknown date, the outcome of the injection site pain and injection site erythema were unknown.   It was unknown if the reporter considered the injection site pain and injection site erythema to be related to Shingrix.  Additional case details were reported as follows: The patient identifiers and vaccine lot number/exp. date was not provided by reporter. The age at vaccination was not reported. The age group was captured as adult as per Shingrix indication.  The healthcare professional reported that there were a number of patients in the past who received the first dose of Shingrix and experienced a reaction such as soreness and redness at the injection sites. These patients do not want to receive the 2nd dose of vaccine. The reporter gave permission to follow up. This case had been linked to the case US2019AMR131512, reported by same reporter.
Sex: F
Vaccine: HEPAB
Symptoms: Vertigo
Clinical narrative: Vertigo; This case was reported by a other health professional via call center representative and described the occurrence of vertigo in a female patient who received HAB (Twinrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Twinrix. On an unknown date, unknown after receiving Twinrix, the patient experienced vertigo. On an unknown date, the outcome of the vertigo was unknown.   The reporter considered the vertigo to be possibly related to Twinrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was getting the accelerated dosing schedule for Twinrix, patient thought they had a reaction of vertigo to hep B portion of the vaccine. The patient reported the vertigo started after receiving the second dose of Twinrix on the accelerated schedule. The reporter did not have the patient information, vaccine information, nor could they consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Injection site swelling, Lethargy
Clinical narrative: Swelling at the injection site; Lethargy; Fatigue; Flu like symptoms; This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In April 2019, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced injection site swelling, lethargy, fatigue and influenza-like symptoms. On an unknown date, the outcome of the injection site swelling, lethargy, fatigue and influenza-like symptoms were recovered/resolved.   It was unknown if the reporter considered the injection site swelling, lethargy, fatigue and influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient did not remember when he had the vaccine, but the symptoms started a few days after the vaccine. The patient experienced swelling at the injection site, lethargy, fatigue, and flu like symptoms for several days. The patient reported that he had a reaction that he hasn't had before with other vaccines. The reporter gave permission to follow up. The outcome reported in the structured field (recovered) and the outcome reported in the source document (Recovered/Resolved with sequelae). So the outcome of events was kept as reported in structured field.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: Flu like symptoms; This case was reported by a pharmacist 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 Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved.   It was unknown if the reporter considered the influenza-like symptoms to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. In 2017, the pharmacist gave a Shingrix vaccination to a local physician, and the local physician gave him a Shingrix vaccination.  The pharmacist did not have any problems, but he said a few days later the physician had flu like symptoms for a couple of days. No further information is available at time of initial report. The reporter did not gave permission to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Headache, Tremor
Clinical narrative: Shaking after Shingirx; Chills after shingrix; Lack of appetite after shingrix; Pounding headache after shingrix; This case was reported by a physician via call center representative and described the occurrence of tremor in a 61-year-old 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 tremor, chills, appetite absent and pounding in head. On an unknown date, the outcome of the tremor, chills, appetite absent and pounding in head were recovered/resolved.   It was unknown if the reporter considered the tremor, chills, appetite absent and pounding in head to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported, but the age vaccination could be 60 or 61 years. The chatter reported 4 days of shaking chills, lack of appetite,  pounding headache after dose 1 of Shingrix. The chatter was healthcare professional and patient and refused to give any additional details including their name. The reporter did not gave permission to follow up.
Age: 57.0
Sex: F
Vaccine: UNK
Symptoms: Acoustic stimulation tests, Tinnitus
Clinical narrative: Vaccine was hepatitis B, but I don't know which brand.  I got tinnitus shortly afterward and it hasn't gone away.  It may be permanent but I won't know for a few months.
Age: 87.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site mass
Clinical narrative: Patient develop a red lump on upper left arm where she received vaccine.  After going to the doctor, she was diagnosed with Cellulitis and given an antibiotic
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Injection site rash, Malaise
Clinical narrative: Patient woke up at about 3 AM the day after the Shingrix vaccine with chills, fever and nausea. She felt very tired and continued to feel weak, tired and ill for the next 3 days following.  She also had a mild rash about 2 inches surrounding the injection site and mild arm pain.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Middle insomnia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Patient woke up at about 3 AM the day after the Shingrix vaccine with chills, fever and nausea. She felt very tired and continued to feel weak, tired and ill for the next 3 days following.  She also had a mild rash about 2 inches surrounding the injection site and mild arm pain.
Age: 19.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Database showed that this person was due for meningoccal conjugate as of 03/13/2019. I asked the patient if she had ever had a meningitis vaccine and she said "No". I did not realize that the vaccines showed up just as Meningococcal. Once putting it into the chart I seen that she had already had vaccines. I reviewed the database again and seen that they were in the Meningococcal spot not the meningococcal conjugate. Health department was contacted and verified that there was no harm to the patient. The patient was contacted as well and was made aware that she received an extra dose of the vaccine. PCP notified as well. Incident report started at my place of employment. Database helpdesk was contacted by clinical directed due to error in database report form.
Sex: U
Vaccine: HIBV, MMR, PPV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: An unspecified number of patients received unspecified doses of improperly stored vaccines; No adverse events; This non-valid spontaneous report was received from a registered nurse who referred to an unspecified number of patients of unknown demographics. No information regarding the patients' pertinent medical history, concomitant therapies and drug reactions or allergies was provided.   On unspecified days, an unspecified number of patients received improperly stored vaccines. The patients were vaccinated with doses of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot# S001329, expiration date 14-JAN-2021, lot # R028382, expiry date 10-MAR-2020 and lot # N024701, expiry date 08-SEP-2019 (exact dose and route of administration were not reported) for prophylaxis.   On unknown dates, the patients were vaccinated with improperly stored doses of Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (LIQUID PEDVAXHIB) lot # N034006, expiration date 01-FEB-2020, lot # R013572, expiration date 21-MAR-2021 (exact dose and route of administration were not reported) for prophylaxis.   On unknown dates, the patients were vaccinated with improperly stored doses of Rotavirus Vaccine, Live, Oral, Pentavalent (ROTATEQ) lot # R002700, expiration date 24-AUG-2019, lot # R034105, expiration date 24-JUN-2020 (exact dose and route of administration were not reported) for prophylaxis.  On unknown dates, the patients were vaccinated with improperly stored doses of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) lot # R002354, expiration date 17-DEC-2019, lot# R010724, expiration date 13-JUN-2020 (exact dose and route of administration were not reported) for prophylaxis. Doses of Pneumococcal Vaccine, Polyvalent (23-valent) (PNEUMOVAX23) were reconstituted with properly stored sterile diluent.   The doses of vaccine were stored at 15.9 °C for 3 hours and 30 minutes. Previous temperature excursion: 10.4°C for 1 hours. Digital data logger was involved. No adverse effects were reported.  This case is non-valid due to lack of patient identifiers.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; Received second dose of M-M-R II and Varivax 26 days after receiving first dose of M-M-R II and Varivax; Information has been received from a pharmacist concerning to a patient (age and gender not reported). No medical history, concurrent conditions nor concomitant medications were reported. On 09-JUN-2019, the patient received the first dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) and the first dose of varicella virus vaccine live (oka/merck)(VARIVAX) (strengths, route of administration, lot numbers and expiration dates were not reported) for prophylaxis.   On 05-JUL-2019 (reported as "26 days after") (inappropriate schedule of product administration), the patient was vaccinated the second dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (Lot number R030808, expiration date 24-OCT-2020) (rHA) (route of administration and strength not reported) and the second dose of varicella virus vaccine live (oka/merck)(VARIVAX) (Lot number R002056, exp. date 22-JAN-2020) (route of administration and strength not reported) for prophylaxis. Both vaccines were reconstituted with sterile diluent (manufacturer unknown) (lot number N031942, exp. date 19-JUL-2020). No adverse event was reported.
Age: 12.0
Sex: F
Vaccine: TDAP
Symptoms: Electrocardiogram abnormal, Syncope
Clinical narrative: Syncope occurred in parking lot of health clinic approximately 5-10  minutes post vaccination with Tdap. She had previously received 5 total doses of DTAP between 2007 and 2011.
Age: 56.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: pain, swelling and redness at injection cite x 2 weeks. Fever and chills x3 days after injection .
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test, C-reactive protein increased, Chest X-ray, Computerised tomogram, Dysstasia
Clinical narrative: Next day after vaccination he was unable to stand up on his own.  Went to ER and was admitted to hospital.  Stayed 4 days.  Had a high fever.  CRP was elevated.  Back to normal after 5 or 6 days. Given an antibiotic. Every test available was taken and unable to find a cause.  Started improving by the next day and after 3 days did not have any symtoms.
Age: 82.0
Sex: M
Vaccine: VARZOS
Symptoms: Laboratory test normal, Nuclear magnetic resonance imaging, Pyrexia
Clinical narrative: Next day after vaccination he was unable to stand up on his own.  Went to ER and was admitted to hospital.  Stayed 4 days.  Had a high fever.  CRP was elevated.  Back to normal after 5 or 6 days. Given an antibiotic. Every test available was taken and unable to find a cause.  Started improving by the next day and after 3 days did not have any symtoms.
Age: 1.0
Sex: F
Vaccine: HIBV, IPV, MMR, VARCEL
Symptoms: Wrong product administered
Clinical narrative: Patient was supposed too receive Hep A vaccine and instead received IPV (dose 2)  on July 24th 2019, 12:15 pm  No further treatment necessary, patient will come back to the clinic to receive Hep A vaccine.
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Arthropathy, Headache, Lymphadenopathy, Pyrexia
Clinical narrative: 7/21/19 onset headache 7/22/19 severe headache, fever 103 degrees F, shaking, joint aches 7/23/19 worsened joint aches, swollen glands 7/24/19 headache, low fever, joint aches 7/25/19 feeling better, but states "joints still feel loose", but not aching
Age: 19.0
Sex: F
Vaccine: MMR
Symptoms: Tremor
Clinical narrative: 7/21/19 onset headache 7/22/19 severe headache, fever 103 degrees F, shaking, joint aches 7/23/19 worsened joint aches, swollen glands 7/24/19 headache, low fever, joint aches 7/25/19 feeling better, but states "joints still feel loose", but not aching
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: Pt received vaccines at HMV on 7/16/19- Tdap, Menactra and HPV.  That evening on left arm where Tdap and Menactra were given pt noticed small location reaction at injection site.  Everyday since then has worsened.  on 7/18 it was painful and pruritic.  7/19 less painful but very pruritic.  Larger area on 19th than 18th.  No fevers. No other hives or rashes noted.  No v or d.   left upper arm with 4in erythematous edematous warm to touch area with pruritus and mild tenderness on palpation.  37.5 mg benadryl given in office waited 25 mins no change in area.  Area unchanged with benadryl so 7 days of Cephalexin treatment done, arm felt/looked better after antibiotics
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site warmth
Clinical narrative: Pt received vaccines at HMV on 7/16/19- Tdap, Menactra and HPV.  That evening on left arm where Tdap and Menactra were given pt noticed small location reaction at injection site.  Everyday since then has worsened.  on 7/18 it was painful and pruritic.  7/19 less painful but very pruritic.  Larger area on 19th than 18th.  No fevers. No other hives or rashes noted.  No v or d.   left upper arm with 4in erythematous edematous warm to touch area with pruritus and mild tenderness on palpation.  37.5 mg benadryl given in office waited 25 mins no change in area.  Area unchanged with benadryl so 7 days of Cephalexin treatment done, arm felt/looked better after antibiotics
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 77 years old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date in 2010, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a currently 80-year-old female patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.  On or about 20-NOV-2009, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route were not specified) for the long-term prevention of shingles and zoster-related conditions. On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a physician for shingles. The outcome of the event was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Dizziness, Feeling hot
Clinical narrative: feeling dizzy; feeling weak; This case was reported by a nurse via sales rep and described the occurrence of dizziness in a 16-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero at an unknown dose. On an unknown date, less than a day after receiving Bexsero, the patient experienced dizziness and feelings of weakness. On an unknown date, the outcome of the dizziness and feelings of weakness were unknown.   It was unknown if the reporter considered the dizziness and feelings of weakness to be related to Bexsero.  Additional details were provided as follows: The patient felt dizzy after shot and also said she felt weak all afternoon after shot. The reporter agreed to follow up from GlaxoSmithKline (GSK).
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling
Clinical narrative: Swelling under arm; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 50-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number 33T42, expiry date 1st February 2021) for prophylaxis.   On 11th July 2019, the patient received Boostrix (intramuscular) .5 ml. On 17th July 2019, 6 days after receiving Boostrix, the patient experienced injection site swelling. On an unknown date, the outcome of the injection site swelling was unknown.   It was unknown if the reporter considered the injection site swelling to be related to Boostrix.  Additional details were provided as follows: The pharmacist stated the patient was administered a dose of Boostrix vaccine in right arm.  On 17th July 2019, the patient was experiencing swelling under the arm at the site of injection where Boostrix was given.  No further details were provided.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Injection site erythema, Skin warm
Clinical narrative: arm swollen; redness in arm; arm was hot to the touch; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 92M54, expiry date 2nd June 2021) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced extensive swelling of vaccinated limb, erythema of extremities and skin warm. On an unknown date, the outcome of the extensive swelling of vaccinated limb, erythema of extremities and skin warm were unknown.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, erythema of extremities and skin warm to be related to Shingrix.  Additional information received were as follows: The age at vaccination was not reported. The patient's whole arm from front to back was red and swollen(extensive swelling of vaccinated limb). The caller also reported that it was hot to the touch and the red spot was size of a soft ball where the vaccine was given.
Age: 80.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Blister, Dyspepsia, Dyspnoea, Erythema, Injection site joint discomfort
Clinical narrative: Swelling of arm, red arm, blisters. extensive pain in arm (8 on scale of 1 to 10) , some usual "shot" discomfort in join above the shot (shoulder) . After I took prednisone, generic antihistamine (benadryl)  and and clindamycin symptoms disappeared but I had a reaction to one or more of these medications--heartburn and shortness of breath--probably the clindamycin because I had never experienced problems with tendril or prednisone in the past. The antibioltic was new.
Age: 80.0
Sex: F
Vaccine: HEP, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Swelling of arm, red arm, blisters. extensive pain in arm (8 on scale of 1 to 10) , some usual "shot" discomfort in join above the shot (shoulder) . After I took prednisone, generic antihistamine (benadryl)  and and clindamycin symptoms disappeared but I had a reaction to one or more of these medications--heartburn and shortness of breath--probably the clindamycin because I had never experienced problems with tendril or prednisone in the past. The antibioltic was new.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Muscle twitching, Myoclonus, Seizure like phenomena, Somnolence
Clinical narrative: This also happened last year but while we suspected it was the vaccine, we couldn't prove it; we thought maybe it was a fluke.  He had an EEG and follow-up with the pediatrician...I am not sure if they ever reported this because I think nobody believed it was related to the vaccine.   Yesterday patient got the serogroup B meningococcal vaccine (his second in the series) and shortly after midnight he started this violent generalized myoclonus/seizure-like activity.   This is the exact same thing that happened last year when he got the first dose of the vaccination (I witnessed both events).   Below is what occurred:   0013-0018 7/26 affecting arms/thighs/chest...able to talk and appropriate mentation, like an uncontrollable, violent shivering in waves (baseline shaking was like somebody really cold but then it would peak to really extreme shivering type activity and subside to it?s baseline and this repeated the pattern several times... weird... just like last time but it didn?t last as long).  O018-23 both lower legs twitching frequently but majority of the myoclonus had subsided.  0024- 0026 mild upper body/ right thigh ?shivering-like? activity, still completely conscious and talking to me.    Afterwards Body felt really worn out but he didn?t seem post-ictal mentally; he said it felt like he just ran a 5K race.  He drank some gatorade and laid there lightly sleeping for an hour or so.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Tremor
Clinical narrative: This also happened last year but while we suspected it was the vaccine, we couldn't prove it; we thought maybe it was a fluke.  He had an EEG and follow-up with the pediatrician...I am not sure if they ever reported this because I think nobody believed it was related to the vaccine.   Yesterday patient got the serogroup B meningococcal vaccine (his second in the series) and shortly after midnight he started this violent generalized myoclonus/seizure-like activity.   This is the exact same thing that happened last year when he got the first dose of the vaccination (I witnessed both events).   Below is what occurred:   0013-0018 7/26 affecting arms/thighs/chest...able to talk and appropriate mentation, like an uncontrollable, violent shivering in waves (baseline shaking was like somebody really cold but then it would peak to really extreme shivering type activity and subside to it?s baseline and this repeated the pattern several times... weird... just like last time but it didn?t last as long).  O018-23 both lower legs twitching frequently but majority of the myoclonus had subsided.  0024- 0026 mild upper body/ right thigh ?shivering-like? activity, still completely conscious and talking to me.    Afterwards Body felt really worn out but he didn?t seem post-ictal mentally; he said it felt like he just ran a 5K race.  He drank some gatorade and laid there lightly sleeping for an hour or so.
Age: 17.0
Sex: M
Vaccine: HEPA, MENB
Symptoms: Syncope
Clinical narrative: had a brief syncopal episode within minutes of receiving the vaccines above.  Completely resolved in 15 minutes.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site erythema, Lymphadenopathy, Pyrexia
Clinical narrative: Fever, chills, redness at injection site and glands swollen at bottom of left side of neck. All started within 24 hours of injection but have since subsided or gone away
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site reaction, Injection site swelling, Injection site warmth
Clinical narrative: I received Shingrix vaccine on the morning of  07/23/2019.  The injection was in the deltoid of my left arm.  Just prior to midnight, I awoke with severe nausea and headache.  I also had significant injection site pain with  slight swelling,  but I expected this to occur.   I took 650 mg. of Tylenol without benefit.  The following day, the nausea and headache persisted and I had an oral temperature of 101.  I also developed a warm, red, macular rash approximately 5 x 7 cm below and medial to the injection site.  On 07/26/2019 I began to feel better.  The nausea and fever have subsided, the headache has improved, and the rash persists.  While I have had multiple vaccines in the past including Zostavax, I have never had such a significant reaction.   I did not seek medical treatment as my husband is a family practice physician.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia, Rash macular
Clinical narrative: I received Shingrix vaccine on the morning of  07/23/2019.  The injection was in the deltoid of my left arm.  Just prior to midnight, I awoke with severe nausea and headache.  I also had significant injection site pain with  slight swelling,  but I expected this to occur.   I took 650 mg. of Tylenol without benefit.  The following day, the nausea and headache persisted and I had an oral temperature of 101.  I also developed a warm, red, macular rash approximately 5 x 7 cm below and medial to the injection site.  On 07/26/2019 I began to feel better.  The nausea and fever have subsided, the headache has improved, and the rash persists.  While I have had multiple vaccines in the past including Zostavax, I have never had such a significant reaction.   I did not seek medical treatment as my husband is a family practice physician.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Hypoaesthesia, Pain in extremity, Paraesthesia, Skin discolouration
Clinical narrative: Patient reports waking up with a sore arm, tingling all over, headache, hand numbness, and a purple colored finger.
Age: 1.17
Sex: M
Vaccine: HEP
Symptoms: Abnormal behaviour, Incorrect dose administered, Pyrexia
Clinical narrative: My 15 month out son was given 1ml of hep b (the adult dose) instead of .5ml the child dose.  He then had a fever of 104. Fever reduced to 102 and lasted 4 days. We?re on the forth day and he?s still not himself.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and referred to a currently 79 years old male patient. No information was provided regarding medical history, concurrent conditions, or concomitant medications.   On an unspecified date 2014, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (lot number, expiration date, dose, dose number and route not specified) for long-term prevention of shingles and zoster-related conditions.  On an unspecified date, the patient experienced shingles. On an unspecified date, the patient was treated by a healthcare provider for shingles. The outcome of the event shingles was not reported. The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).  Additional information has been requested.
Age: 1.33
Sex: U
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: no adverse effects; dose of PEDV AXHIB tbat was inadvertently administered past its expiration.; This spontaneous report was received from a medical assistant and refers to a 16-month-old patient of unknown gender. There was no information regarding patient's pertinent medical history, drug reactions, allergies and concomitant therapies provided. On 15-JUL-2019, the patient was inadvertently administered a dose of expired haemophilus b conjugate vaccine (meningococcal protein conjugate) (LIQUID PEDVAXHIB) injection (lot # M045207 has been verified to be a valid lot number, expiration date 30-JUN-2019) (exact dose and route of administration were not provided) for prophylaxis. The reporter informed that the clinic did not share information regarding any adverse event and had no VAERS reference.
Sex: F
Vaccine: TDAP
Symptoms: Apparent death, Malaise, Pertussis, Vaccination failure
Clinical narrative: pertussis; almost lost my baby; Ill; Suspected vaccination failure; This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a female patient who received DTPa (DTPa vaccine) for prophylaxis.   On an unknown date, the patient received DTPa vaccine at an unknown dose. On an unknown date, unknown after receiving DTPa vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), pertussis (serious criteria hospitalization and GSK medically significant), near death experience (serious criteria GSK medically significant) and unwell. On an unknown date, the outcome of the vaccination failure and unwell were unknown and the outcome of the pertussis and near death experience were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, pertussis, near death experience and unwell to be related to DTPa vaccine.  Additional information was provided as follows: This case received from interactive digital media. The patient's mother reported all the information. The age at vaccination was not reported. When the patient under the age of one year, she got all her vaccinations. After the Infanrix shot, she had pertussis (she was very ill). The patient's oldest sister also had pertussis and their physician put 16 other peoples on antibiotics anyone who had come in contact with them. They were in hospital almost for a month. The patient's mother reported that she almost lost her baby.and it was devastating to watch. At the time of reporting the patient would turn 26 and she had a wonderful life despite getting scary beginning. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation were unknown at the time of reporting.