chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Rash vesicular
Clinical narrative: Pain and stinging at injection site/; shingles rash that looks like pimples/rash that looks like pimples on her face,scalp,ears,chest, and back; Shingles / Shingles rash that looks like pimples; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles and brain injury (had brain injury from a car accident several years ago).   On 8th June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 11th June 2020, 3 days after receiving Shingrix, the patient experienced shingles and vesicular rash. On an unknown date, the patient experienced injection site pain. The patient was treated with topical steroid nos (Steroid Cream). On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the injection site pain was recovered/resolved and the outcome of the vesicular rash was unknown.   It was unknown if the reporter considered the shingles, injection site pain and vesicular rash to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in left arm and had outbreak of shingles that began 3 or 4 days and lasted about 3 to 4 weeks before resolving. The patient reported a second outbreak of shingles began 4 days ago and was ongoing currently.  The patient stated currently has a shingles rash that looks like pimples on her face, scalp, ears, chest, and back that began 4 days ago and has been using a steroid cream to treat this.  The patient reported pain and stinging at injection site and these had resolved.  The reporter did not consent to follow up. No lot number or expiration date information was available The reporter did not get consent to follow up with HCP.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Glossopharyngeal neuralgia, Trigeminal neuralgia
Clinical narrative: Trigeminal neuralgia; glossopharyngeal neuralgia; This case was reported by a consumer via call center representative and described the occurrence of trigeminal neuralgia in a 60-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix (intramuscular). In April 2020, between 1 and 3 months after receiving Shingrix, the patient experienced trigeminal neuralgia and glossopharyngeal neuralgia. On an unknown date, the outcome of the trigeminal neuralgia was not recovered/not resolved and the outcome of the glossopharyngeal neuralgia was unknown.   It was unknown if the reporter considered the trigeminal neuralgia and glossopharyngeal neuralgia to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in left arm and was diagnosed with Trigeminal and glossopharyngeal neuralgia. The patient had concern that the condition was related to the vaccination and had not received her second dose yet. The reporter consented to follow up.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Asthenia, Dyspnoea, Hypoaesthesia, Pain, Paraesthesia
Clinical narrative: fainted; pain; tingling; numbness; difficulty breathing; felt very weak/bad reaction; This case was reported by a other health professional via call center representative and described the occurrence of fainting in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA94AA, expiry date 28th February 2022) for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 23rd July 2020, the patient received the 2nd dose of Bexsero. On 23rd July 2020, 1 hr after receiving Bexsero, the patient experienced fainting (serious criteria GSK medically significant), pain, tingling, numbness, difficulty breathing and feelings of weakness. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the fainting, pain, tingling, numbness and difficulty breathing were unknown and the outcome of the feelings of weakness was not recovered/not resolved.   It was unknown if the reporter considered the fainting, pain, tingling, numbness, difficulty breathing and feelings of weakness to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero in right upper deltoid.  The patient was okay for about 30 minutes in the doctor's office and also, she was okay for about 30 minutes after reaching home.  Around 1 hour after receiving the vaccine, the patient started to feel pain, tingling and numbness in her whole body and she fainted.  The patient was having breathing difficulty and felt very weak. The patient was taken to the emergency room and was given fluids and pain medications overnight and at the time of reporting she was at home. But the patient was still feeling very weak.  Doctor's office stating, the patient had a very bad reaction to the Bexsero. The reporter was consented to follow up.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Syncope, Vaccination complication
Clinical narrative: fainted; pain; tingling; numbness; difficulty breathing; felt very weak/bad reaction; This case was reported by a other health professional via call center representative and described the occurrence of fainting in a 18-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA94AA, expiry date 28th February 2022) for prophylaxis.   Concomitant products included Men B NVS (Bexsero).   On 23rd July 2020, the patient received the 2nd dose of Bexsero. On 23rd July 2020, 1 hr after receiving Bexsero, the patient experienced fainting (serious criteria GSK medically significant), pain, tingling, numbness, difficulty breathing and feelings of weakness. The patient was treated with analgesic, nos (Pain Medication). On an unknown date, the outcome of the fainting, pain, tingling, numbness and difficulty breathing were unknown and the outcome of the feelings of weakness was not recovered/not resolved.   It was unknown if the reporter considered the fainting, pain, tingling, numbness, difficulty breathing and feelings of weakness to be related to Bexsero.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Bexsero in right upper deltoid.  The patient was okay for about 30 minutes in the doctor's office and also, she was okay for about 30 minutes after reaching home.  Around 1 hour after receiving the vaccine, the patient started to feel pain, tingling and numbness in her whole body and she fainted.  The patient was having breathing difficulty and felt very weak. The patient was taken to the emergency room and was given fluids and pain medications overnight and at the time of reporting she was at home. But the patient was still feeling very weak.  Doctor's office stating, the patient had a very bad reaction to the Bexsero. The reporter was consented to follow up.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Crying, Feeling abnormal, Oropharyngeal discomfort
Clinical narrative: She felt awful; Her throat felt weird; crying; This is a spontaneous report from a contactable consumer via Pfizer sales representative. This consumer (patient's mother) reported that a 18-year-old female patient received her first dose of meningococcal group b rlp2086 (TRUMENBA) via unknown routed of administration on unknown date around 3:00 pm at single dose for Immunization. Patient recently recovered from COVID four weeks prior. Concomitant medications were not reported. Later that evening, around 7 PM, she told her mother that she felt awful. She started crying saying that her throat felt weird. She did not experience shortness of breath or difficulty breathing. Her mother administered Advil. No other vaccinations were given at visit. Outcome of events was unknown.   No follow-up attempts are possible; information about lot/batch number cannot be obtained.
Sex: U
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Product preparation error
Clinical narrative: undiluted Hib portion of Pentacel was in their office, and the corresponding DTaP-IPV diluent was missing, Nurse presumes a patient was given the diluent alone, no AE; Initial information received on 27-Jul-2020 regarding an unsolicited valid non-serious case from a nurse.  This case involves a patient (age and gender not reported) who received a 0.5 mL dose of only diluent component of DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV(MRC5)/HIB(PRP/T) VACCINE [PENTACEL] (lot UJ217AAA, expiry date 06-Apr-2021 via an unknown route at an unknown administration site) as prophylactic vaccination on an unknown date (product preparation issue).   The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.  It was an actual medication error case due to inappropriate reconstitution technique.  It was reported that undiluted Hib portion of Pentacel was in their office, and the corresponding DTaP-IPV diluent was missing. Nurse presumed a patient was given the diluent alone, does not know which particular patient was involved because it has been a very busy Monday at their office.   At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Gait disturbance, Myalgia, Pyrexia
Clinical narrative: approximately 12 hrs. after receiving shot, i woke up because of being extremely cold, could not warm up or sleep, took temp 4 hrs later and was 100.8, experienced difficulty even walking at that time muscles all thru body hurt. Headache that i already had previous to shot became worse.  Took tylenol for fever. pain and fever subsided in less than 24 hrs from onset.  Contacted pharmacy regarding adverse reaction and neurologist i had seen the previous week.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis at vaccine site requiring treatment with Keflex.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Eye pain, Headache, Myalgia, Pyrexia
Clinical narrative: Fever of 99.1-100.0, severe headache, orbital and neck muscle aches.
Age: 2.0
Sex: M
Vaccine: VARCEL
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis at site of vaccine administration.
Age: 23.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Acoustic stimulation tests abnormal, Deafness, Tinnitus
Clinical narrative: Hearing loss and tinnitus
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Fatigue, minor headache, dizziness.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Herpes zoster, Pain
Clinical narrative: Shingles; Extreme Pain; Increased BP; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1si dose received in April 2020).   On 2nd July 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 2nd July 2020, less than a day after receiving Shingrix, the patient experienced shingles, pain and increased blood pressure. On an unknown date, the outcome of the shingles, pain and increased blood pressure were unknown.   It was unknown if the reporter considered the shingles, pain and increased blood pressure to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient experienced the symptoms of extreme pain, increased blood pressure and the shingles on the same day she got her 2nd dose. The patient reported her blood pressure was so high and went to the urgent care and they sent her to the hospital and they released. The reporter consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Dizziness, Head discomfort, Headache, Hypoaesthesia
Clinical narrative: Head / discomfort; dizzy; facial numbness; Sharp pain in head; Unusual headache / Vascular / in different places on her head / uncomfortable and annoying / Sharp pain in her head; Soreness and pain after receiving the vaccine at the injection site; annoying; uncomfortable; This case was reported by a nurse via call center representative and described the occurrence of vascular headache in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 12th June 2020, 1 days after receiving Shingrix, the patient experienced injection site pain. In June 2020, the patient experienced feeling irritated and discomfort. On 8th July 2020, the patient experienced dizziness, numbness facial and headache. In July 2020, the patient experienced vascular headache. On an unknown date, the patient experienced head discomfort. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the vascular headache, dizziness, numbness facial, injection site pain, head discomfort, feeling irritated, discomfort and headache were unknown.   It was unknown if the reporter considered the vascular headache, dizziness, numbness facial, injection site pain, head discomfort, feeling irritated, discomfort and headache to be related to Shingrix.  Additional case details were reported as follows: The patient received the 1st dose of Shingrix on 11th June 2020, and within the first week she developed an unusual headache on the outer side of her head that was vascular and she would get the headache in different places on her head and it would last all day and it was uncomfortable and annoying.  The Tylenol would help the headache some and massaging the area helped.  Two weeks ago, she was watching television and she experienced a sharp pain in her head and it left her dizzy and afterwards while she was sitting down she had facial numbness that would come and go and then the headache would start.  Three days ago, she has had some relief from the moving headache in her head but she still has the facial numbness. Things were currently improving overall. The numbness occurs on her forehead and it was earlier around her eyes. On 12th July 2020, the experienced soreness and pain after receiving the vaccine at the injection site that lasted close to a week and started. When she tilts her head, it makes the pain worse and rubbing the area and massaging the area also helps to ease the discomfort. She felt like the pain was on the outer edge of her head. She had an appointment with a neurologist.  The reporter consent to follow up.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Irritability, Vascular headache
Clinical narrative: Head / discomfort; dizzy; facial numbness; Sharp pain in head; Unusual headache / Vascular / in different places on her head / uncomfortable and annoying / Sharp pain in her head; Soreness and pain after receiving the vaccine at the injection site; annoying; uncomfortable; This case was reported by a nurse via call center representative and described the occurrence of vascular headache in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11th June 2020, the patient received the 1st dose of Shingrix (intramuscular). On 12th June 2020, 1 days after receiving Shingrix, the patient experienced injection site pain. In June 2020, the patient experienced feeling irritated and discomfort. On 8th July 2020, the patient experienced dizziness, numbness facial and headache. In July 2020, the patient experienced vascular headache. On an unknown date, the patient experienced head discomfort. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the vascular headache, dizziness, numbness facial, injection site pain, head discomfort, feeling irritated, discomfort and headache were unknown.   It was unknown if the reporter considered the vascular headache, dizziness, numbness facial, injection site pain, head discomfort, feeling irritated, discomfort and headache to be related to Shingrix.  Additional case details were reported as follows: The patient received the 1st dose of Shingrix on 11th June 2020, and within the first week she developed an unusual headache on the outer side of her head that was vascular and she would get the headache in different places on her head and it would last all day and it was uncomfortable and annoying.  The Tylenol would help the headache some and massaging the area helped.  Two weeks ago, she was watching television and she experienced a sharp pain in her head and it left her dizzy and afterwards while she was sitting down she had facial numbness that would come and go and then the headache would start.  Three days ago, she has had some relief from the moving headache in her head but she still has the facial numbness. Things were currently improving overall. The numbness occurs on her forehead and it was earlier around her eyes. On 12th July 2020, the experienced soreness and pain after receiving the vaccine at the injection site that lasted close to a week and started. When she tilts her head, it makes the pain worse and rubbing the area and massaging the area also helps to ease the discomfort. She felt like the pain was on the outer edge of her head. She had an appointment with a neurologist.  The reporter consent to follow up.
Age: 55.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Chills, Feeling cold, Pyrexia, Tremor
Clinical narrative: Fever; was Shaking; Cold chills; cold; This case was reported by a consumer via call center representative and described the occurrence of fever in a 55-year-old male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included DTPa (Reduced antigen) (dTpa vaccine) for prophylaxis.   Concomitant products included paracetamol (Tylenol).   On 20th July 2020, the patient received Shingles vaccine and dTpa vaccine. On 20th July 2020, less than a day after receiving Shingles vaccine and dTpa vaccine, the patient experienced fever, tremor, chills and cold. On an unknown date, the outcome of the fever and cold were unknown and the outcome of the tremor and chills were not recovered/not resolved.   It was unknown if the reporter considered the fever, tremor, chills and cold to be related to Shingles vaccine and dTpa vaccine.  Additional case details were reported as follows: The case was reported by the spouse of the patient. The patient started having symptoms during the evening of 20th July 2020.  The patient experienced high fever, cold chills, and was shaking. The reporter was provided with the names and adverse reactions information for Shingrix and Boostrix brands.  The patient received since they do not know the brand names of these specific formulations. The reporter consent to follow up.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Adverse reaction, Chills, Fatigue, Headache, Pyrexia
Clinical narrative: chills; headache; tiredness; fever; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included asthma.   In November 2019, the patient received the 1st dose of Shingrix. In November 2019, 10 hrs 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 recovered/resolved.   It was unknown if the reporter considered the fever, chills, headache and tiredness to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. In November 2019 at 3.00 pm, the patient received the 1st dose of Shingrix. In November 2019 at 1.00am , the patient experienced adverse reactions. The adverse events lasted 48 hours. The reporter consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Pain, Pain in extremity
Clinical narrative: Shivering; Weak; feeling achy; Fever; Sore arm/inj site pain/pain in arm; been Tired/staying home; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd September 2019, couple of hours after receiving Shingrix, the patient experienced pain in arm. On 4th September 2019, the patient experienced tiredness, shivering, weakness, pain and fever. On 5th September 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain in arm, tiredness, shivering, weakness and pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tiredness, shivering, weakness, pain and fever to be related to Shingrix.  Additional case details were reported as follows: The patient received the 1st dose of Shingrix in right arm. The patient experienced painful resulting in a sore arm a few hours later.  On 4th September 2019, the patient experienced fever, feeling achy, weak, shivering, and being tired. The patient stayed at home for two days. Fever reported to be gone the following day.  The reporter did not consent to follow up. For tolerance to 2nd dose refer linked case US2020AMR140996, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR140996:first dose
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Shivering; Weak; feeling achy; Fever; Sore arm/inj site pain/pain in arm; been Tired/staying home; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 3rd September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 3rd September 2019, couple of hours after receiving Shingrix, the patient experienced pain in arm. On 4th September 2019, the patient experienced tiredness, shivering, weakness, pain and fever. On 5th September 2019, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the pain in arm, tiredness, shivering, weakness and pain were recovered/resolved.   It was unknown if the reporter considered the pain in arm, tiredness, shivering, weakness, pain and fever to be related to Shingrix.  Additional case details were reported as follows: The patient received the 1st dose of Shingrix in right arm. The patient experienced painful resulting in a sore arm a few hours later.  On 4th September 2019, the patient experienced fever, feeling achy, weak, shivering, and being tired. The patient stayed at home for two days. Fever reported to be gone the following day.  The reporter did not consent to follow up. For tolerance to 2nd dose refer linked case US2020AMR140996, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR140996:first dose
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: fever; arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2020, the patient received the 1st dose of Shingrix. On 27th July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On 28th July 2020, the patient experienced fever. Shingrix was continued with no change. On an unknown date, the outcome of the pain in arm and fever were unknown.   It was unknown if the reporter considered the pain in arm and fever to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. After receiving Shinrix, the patient experianced arm pain and fever. The reporter was consented to follow up. This case was linked with case US2020144254, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020144254:same reporter
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: arm pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th July 2020, the patient received the 1st dose of Shingrix. On 27th July 2020, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. After receiving Shingrix, the patient experienced arm pain. The reporter was consented to follow up. This case was linked with case US2020144253, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020144253:same report
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: PT came in to pharmacy this morning stating that she had received her 1st Shingrix last week (7/25/20). She did not have any reactions until 2 days after the vaccine was administered. She states a rash about the 1"x2" appeared ~1.5" below the injection. She denies having any fever.  She did confirm that there is itching where the rash is. The rash increased in size today (7/31/20) which is why she came in to notify us. The rash was about 2.5"x4" below the actual injection point (per pt).
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Musculoskeletal pain, Neck pain, Pain in extremity
Clinical narrative: Pain in arm, shoulder, neck
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Discomfort, Disorientation, Dizziness, Insomnia
Clinical narrative: "Starting around 3PM or so the localized muscle pain, stiffness around the vacc site became pretty intense. Got to the point that about 7 or so I put an ice bag on it to help, half hour later I started having body shaking chills and from that point on for several hours, I got sicker than I've been for some time. Didn't vomit but felt very nauseous and the chills turned to feelings of strong fever accompanied by even some disorientation. Took my temp a couple times, 1st was 97.7 and a couple hrs later went up only as far as 99.5, which of course isn't that bad, however the way I felt I expected it to be 102 or so... Tried to go to bed at 10PM, but had a lot of discomfort and only had spot dozing until probably 3AM, when I finally drifted off to some decent sleep. This morning I feel kind of lightheaded, with only mild pain at the vacc site"
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Musculoskeletal stiffness, Myalgia, Nausea, Pyrexia
Clinical narrative: "Starting around 3PM or so the localized muscle pain, stiffness around the vacc site became pretty intense. Got to the point that about 7 or so I put an ice bag on it to help, half hour later I started having body shaking chills and from that point on for several hours, I got sicker than I've been for some time. Didn't vomit but felt very nauseous and the chills turned to feelings of strong fever accompanied by even some disorientation. Took my temp a couple times, 1st was 97.7 and a couple hrs later went up only as far as 99.5, which of course isn't that bad, however the way I felt I expected it to be 102 or so... Tried to go to bed at 10PM, but had a lot of discomfort and only had spot dozing until probably 3AM, when I finally drifted off to some decent sleep. This morning I feel kind of lightheaded, with only mild pain at the vacc site"
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Tremor, Vaccination site pain, Vaccination site reaction
Clinical narrative: "Starting around 3PM or so the localized muscle pain, stiffness around the vacc site became pretty intense. Got to the point that about 7 or so I put an ice bag on it to help, half hour later I started having body shaking chills and from that point on for several hours, I got sicker than I've been for some time. Didn't vomit but felt very nauseous and the chills turned to feelings of strong fever accompanied by even some disorientation. Took my temp a couple times, 1st was 97.7 and a couple hrs later went up only as far as 99.5, which of course isn't that bad, however the way I felt I expected it to be 102 or so... Tried to go to bed at 10PM, but had a lot of discomfort and only had spot dozing until probably 3AM, when I finally drifted off to some decent sleep. This morning I feel kind of lightheaded, with only mild pain at the vacc site"
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No other adverse effects were reported in the patient; patient received a dose of PROQUAD on 7/15/2020 following a temperature excursion; This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent conditions, medical history, drug reactions or allergies and concomitant medications was provided.  On 15-JUL-2020, the patient was vaccinated with improperly stored dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # S015238 was verified to be a not valid lot number, expiration date reported as 01-DEC-2020 (exact dose, dose number, vaccination site and route of administration were not provided) for prophylaxis.  Administered dose of vaccine was exposed to the temperature excursion of -11.77 degrees Celsius for 2 hours. There were previous temperature excursions, -10.45 degrees Celsius for 12 hours 45 minutes and -8.77 degrees Celsius for 13 hours on unknown dates. Digital Data Logger was involved. No other adverse effects were reported.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional adverse event; the patient was inadvertently administered a dose of ZOSTAVAX that was expired; This spontaneous report was received from a registered nurse who refers to a 62-year-old, female patient. No information regarding her medical history, concurrent conditions, concomitant medications, drug reactions or allergies was provided.  On 13-JUL-2020, the patient was inadvertently vaccinated with expired dose of zoster vaccine live (ZOSTAVAX), lot # S002390, expiration date was not provided but upon internal validation established as 22-APR-2020 (exact dose, strength, route of administration and anatomical location were not reported) for prophylaxis (expired product administered). No additional adverse event was reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; on 17-JUL-2020 a patient was administered an improperly stored VARIVAX; This spontaneous report was received from an office manager referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, concomitant therapies, and previous drug reaction, or allergies was not provided.  On 17-JUL-2020, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) injection (strength, dose, frequency, route of administration, and anatomical location were not reported; lot number S028925, expiration date 16-SEP-2021) for prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (MERCK STERILE DILUENT).  On 17-JUL-2020, the vaccine was stored in a temperatures of 6 degrees Fahrenheit (F) to 14 F (9.0 F) for 1 hour, from 15 F to 46 F (45.9 F) for 10 hours and 30 minutes; and starting at 10:07 pm, in a temperature from -47 F to 77 F (77 F) for 15 hours. On 18-JUL-2020, starting at 2:52 pm, the vaccine was stored in a temperature of -78 F/26 degrees Celsius or warmer (79.5 F) for 32 hours. There was no previous temperature excursion. The temperature excursions were not call because of a data logger. No additional adverse events were reported.  This is one of five reports received from the same reporter.; Sender's Comments:  US-009507513-2007USA007875: US-009507513-2007USA007982: US-009507513-2007USA008008: US-009507513-2007USA008263:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: post-herpetic neuralgia; shingles; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding concurrent conditions, medical history, or concomitant medications.  On or about 25-AUG-2012, the patient was inoculated with zoster vaccine live (ZOSTAVAX) for routine maintenance and for its intended purpose: the prevention of shingles (herpes zoster) (dose, route of administration, lot # and expiration date were not provided) On an unknown date, reported as shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered outbreak of shingles and post-herpetic neuralgia. As a result of these symptoms, the patient was seen and treated by medical providers and at the time of the report, the patient was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX) vaccine, the patient's symptoms have resulted in physical limitations not present prior to using zoster vaccine live (ZOSTAVAX). The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of Company's wrongful conduct, the patient suffered serious, progressive, permanent and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of Company's conduct, the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The outcome of the events was reported as not recovered. The reporter considered the events to be related to zoster vaccine live (ZOSTAVAX).  The events of shingles and post-herpetic neuralgia were considered to be disabling.
Sex: U
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 patient of unknown age and gender. No information was provided regarding concurrent conditions, medical history, or concomitant medications.  On or about 01-MAR-2017, the patient was inoculated with zoster vaccine live (ZOSTAVAX) (dose, route of administration, lot # and expiration date were not provided) for the long-term prevention of shingles and zoster-related conditions. On an unknown date, reported as subsequent to the patient's zoster vaccine live (ZOSTAVAX) inoculation, the patient was treated for shingles. As a direct and proximate result of the patient's use of the zoster vaccine live (ZOSTAVAX) vaccine, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. The outcome of the event was not provided.  The reporter considered the event to be related to zoster vaccine live (ZOSTAVAX).
Sex: M
Vaccine: MMR
Symptoms: Condition aggravated, Measles antibody, Measles post vaccine, Mumps antibody test negative, Psoriasis
Clinical narrative: I had Measles; Nurse reported he developed psoriasis on an unspecified date.; Nurse reported he has a "negative titer for mumps".; This spontaneous report was received from a male nurse of unknown age, referring to himself. His concomitant therapies included (TREMFYA). The patient had no previous drug reactions or allergies.      On an unknown date,  when the patient was a child, he was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (dose number, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), as prophylaxis. Other suspect therapies included a sterile diluent (MERCK STERILE DILUENT) (dose, lot number and expiration date were not provided).   On an unknown date, the nurse reported that he had measles (medically significant) and developed psoriasis (also reported as "pertinent medical history", conflicting information). Also, he reported he had measles, mumps and rubella (MMR) titers on an unspecified date and was negative titer for mumps (mumps antibody test negative). The patient did not seek medical attention and there was not treatment given for the adverse events.      At the time of reporting, the outcome of measles was unknown and for the events of psoriasis and mumps antibody test negative, was reported as not recovered/not resolved. The causal relationship between the suspect drugs and the aforementioned events was not provided.  Upon internal review, the event of measles was considered medically significant.
Sex: M
Vaccine: MMR
Symptoms: Rubella antibody test
Clinical narrative: I had Measles; Nurse reported he developed psoriasis on an unspecified date.; Nurse reported he has a "negative titer for mumps".; This spontaneous report was received from a male nurse of unknown age, referring to himself. His concomitant therapies included (TREMFYA). The patient had no previous drug reactions or allergies.      On an unknown date,  when the patient was a child, he was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection (dose number, vaccination scheme, route of administration, anatomical site of vaccination, lot number and expiration date were not provided), as prophylaxis. Other suspect therapies included a sterile diluent (MERCK STERILE DILUENT) (dose, lot number and expiration date were not provided).   On an unknown date, the nurse reported that he had measles (medically significant) and developed psoriasis (also reported as "pertinent medical history", conflicting information). Also, he reported he had measles, mumps and rubella (MMR) titers on an unspecified date and was negative titer for mumps (mumps antibody test negative). The patient did not seek medical attention and there was not treatment given for the adverse events.      At the time of reporting, the outcome of measles was unknown and for the events of psoriasis and mumps antibody test negative, was reported as not recovered/not resolved. The causal relationship between the suspect drugs and the aforementioned events was not provided.  Upon internal review, the event of measles was considered medically significant.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event.; the patient was inadvertently administered a dose of VARIVAX, that had been improperly stored.; This spontaneous report was received from a nurse, referring to a 5-year-old female patient. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.  On 20-JUL-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) injection (lot number T002844 which has been verified to be valid, expiration date reported and validated as 23-JAN-2022) (dosage, vaccination scheme, frequency, route of administration and anatomical site of injection were not reported) as prophylaxis (product storage error). The vaccine was reconstituted with properly stored sterile diluent (DILUENT MRK). The administered dose of the vaccine was stored at a temperature of 70 degrees Fahrenheit, during a time frame of 48 hours, as recorded by a digital data logger. There was no previous temperature excursion. No additional adverse events were reported in the patient.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: a 2 inch by 3 inch area of swelling and redness on her arm near the injection site; a 2 inch by 3 inch area of swelling and redness on her arm near the injection site; This spontaneous report as received from a pharmacist refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications was provided. On 21-JUL-2020, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) (dose, route of administration, lot number and expiration date were not reported) for prophylaxis. On 22-JUL-2020, the patient experienced a 2 inch by 3 inch area of swelling and redness on her arm near the injection site. The outcome of the events was not reported. The relatedness between the events and pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) was not provided.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Alopecia, Blood test normal, Contusion, Madarosis, Rash
Clinical narrative: Skin rash and bruising. Hair loss almost immediately.  Came out in circular quarter sized patches at first and by July 2019 she was half bald. By October,  her eyebrows and lashes went, too. Dermatologist and rheumatologist seen. Steroids not used per parental decision. Blood tests show no autoimmune.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Alopecia, Antinuclear antibody negative, C-reactive protein normal, Culture throat negative, Full blood count normal
Clinical narrative: Skin rash and bruising. Hair loss almost immediately.  Came out in circular quarter sized patches at first and by July 2019 she was half bald. By October,  her eyebrows and lashes went, too. Dermatologist and rheumatologist seen. Steroids not used per parental decision. Blood tests show no autoimmune.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site bruising, Injection site rash, Oropharyngeal pain, Rheumatoid factor negative, Thyroid function test normal
Clinical narrative: Skin rash and bruising. Hair loss almost immediately.  Came out in circular quarter sized patches at first and by July 2019 she was half bald. By October,  her eyebrows and lashes went, too. Dermatologist and rheumatologist seen. Steroids not used per parental decision. Blood tests show no autoimmune.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Alopecia, Blood test normal, Contusion, Madarosis, Rash
Clinical narrative: MOM REPORTS THAT WITHIN 2 WEEKS OF RECEIVING THE VACCINE PATIENT DEVELOPED BRUISING AND A RASH AROUND THE INJECTION SITE - RESOLVED WITH OUT BEING EVALUATED. ALSO WITH IN 2 WEEKS A PATCH OF PATIENT'S HAIR FELL OUT AND CONTINUED TO FALL OUT FROM THAT TIME ON. WAS SEEN BY PCP (DR. ON 5/21) FOR HAIR LOSS AND SORE THROAT. LABS WERE ORDERED THAT WERE ESSENTIALLY NORMAL. PATIENT WAS REFERRED TO DERMATOLOGY AND RHUEMATOLOGY FOR EVALUATION.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Alopecia, Antinuclear antibody negative, C-reactive protein normal, Culture throat negative, Full blood count normal
Clinical narrative: MOM REPORTS THAT WITHIN 2 WEEKS OF RECEIVING THE VACCINE PATIENT DEVELOPED BRUISING AND A RASH AROUND THE INJECTION SITE - RESOLVED WITH OUT BEING EVALUATED. ALSO WITH IN 2 WEEKS A PATCH OF PATIENT'S HAIR FELL OUT AND CONTINUED TO FALL OUT FROM THAT TIME ON. WAS SEEN BY PCP (DR. ON 5/21) FOR HAIR LOSS AND SORE THROAT. LABS WERE ORDERED THAT WERE ESSENTIALLY NORMAL. PATIENT WAS REFERRED TO DERMATOLOGY AND RHUEMATOLOGY FOR EVALUATION.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, DTAPIPV
Symptoms: Injection site bruising, Injection site rash, Oropharyngeal pain, Rheumatoid factor negative, Thyroid function test normal
Clinical narrative: MOM REPORTS THAT WITHIN 2 WEEKS OF RECEIVING THE VACCINE PATIENT DEVELOPED BRUISING AND A RASH AROUND THE INJECTION SITE - RESOLVED WITH OUT BEING EVALUATED. ALSO WITH IN 2 WEEKS A PATCH OF PATIENT'S HAIR FELL OUT AND CONTINUED TO FALL OUT FROM THAT TIME ON. WAS SEEN BY PCP (DR. ON 5/21) FOR HAIR LOSS AND SORE THROAT. LABS WERE ORDERED THAT WERE ESSENTIALLY NORMAL. PATIENT WAS REFERRED TO DERMATOLOGY AND RHUEMATOLOGY FOR EVALUATION.
Age: 1.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: expired VAQTA administered; This spontaneous report was received from an office manager, via company representative and  refers to a 1 year old female patient. No information given received regarding the patient's concurrent conditions, concomitant medications or medical history.     On 22-JUL-2020, the patient was vaccinated with an expired dose of  hepatitis a vaccine, inactivated(VAQTA), with expiration date on 11-JUL-2020, intramuscular for prophylaxis (dose and lot number were not reported). No product quality issue was reported.  This is one of two reports from the same reporter.
Age: 67.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site rash
Clinical narrative: Rash at injection site that spread to inner arm
Age: 1.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: no issues; Expired VAQTA given last night; This spontaneous report was received from an office manager via a company representative, referring to an one-year-old male patient. The patient's pertinent medical history, concurrent conditions, previous drug allergies or reactions and concomitant medications were not reported.  On 22-JUL-2020, the patient was vaccinated with an expired dose of hepatitis a vaccine, inactivated (VAQTA) administered intramuscularly (exact dose, injection site and lot number were not provided, expiration date reported as 11-JUL-2020) for prophylaxis. His present status was described as no issues.  This is one of two reports concerning siblings.; Sender's Comments:  US-009507513-2007USA009441:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered
Clinical narrative: The patient was administered a properly stored but expired vaccine; This spontaneous report was received from an office manager concerning a patient of unknown age an gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.  On 24-JUL-2020, the patient was vaccinated with the first dose of a properly stored but expired pneumococcal vaccine, polyvalent (23-valent) (PNEUM OVAX23), lot number R012550 with expiration date 25-JAN-2020 for prophylaxis (route of administration was not provided). No additional information was provided and no product quality complaint (PQC) was reported.  At the reporting time, the patient's outcome was unknown. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: R012550; expirationdate: 25-JAN-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability