chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain
Clinical narrative: This case was reported by a consumer and described the occurrence of nausea in a female patient who received SHINGRIX for prophylaxis. On 5th June 2018, the patient received SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced nausea, general body pain, headache and tiredness. On an unknown date, the outcome of the nausea, general body pain, headache and tiredness were unknown. It was unknown if the reporter considered the nausea, general body pain, headache and tiredness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The reporter know that folks were aware of these side effects of the SHINGRIX vaccine, but thought that the frequency of them occurring might be something track. So, the reporter would just like to report that got first shot on the day before reporting 5th June 2018. The patient usually suffered the stated side effects of vaccinations, but SHINGRIX seems to be hitting hard: nausea, aching all over (not sure if it was muscle or joint), headache and extremely tired.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Laboratory test normal, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 16-year-old male patient who received MENVEO for prophylaxis. Co-suspect products included TRUMENBA for an unknown indication. On 30th May 2018, the patient received MENVEO. On an unknown date, the patient started TRUMENBA at an unknown dose and frequency. In May 2018, less than a day after receiving MENVEO, the patient experienced fever. On an unknown date, the outcome of the fever was not recovered/not resolved. It was unknown if the reporter considered the fever to be related to MENVEO. Additional details were provided as follows: The reporter was not a healthcare professional but a very concerned parent. The reporter's son received Meningococcal vaccines last Wednesday and had suffered from a fever since. The reporter had taken the patient to emergency room on Saturday due to a 106 temperature. All labs were normal. No sign of viral or bacterial infection were found. The reporter had been doing some research on vaccines to determine if this was an adverse side effect. He was asking was a 7 days temperature normal. The reporter agreed to be contacted for follow up. The reporter provided contact details of his son's physician and mentioned there were several doctors in facility, there is no main doctor he sees. The patient also had an appointment on the reporting date with the physician.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Malaise, Myalgia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of myalgia in a 18-year-old female patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 1st dose of BEXSERO .5 ml. On an unknown date, unknown after receiving BEXSERO, the patient experienced myalgia and malaise. On an unknown date, the outcome of the myalgia and malaise were unknown. It was unknown if the reporter considered the myalgia and malaise to be related to BEXSERO. Additional details were provided as follows: The patient received BEXSERO on an unknown date (event happened a couple years back). The healthcare professional reported that the patient reported myalgia and malaise following administration of BEXSERO. The adverse event were resolved after a day later. This events were occurred a couple years back healthcare professional did not know exact date. The healthcare professional did not report this previously because it is a known adverse event.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Product administered at inappropriate site
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site reaction in a adult patient who received SHINGRIX for prophylaxis. 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 injection site reaction and vaccine administered at inappropriate site. On an unknown date, the outcome of the injection site reaction and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site reaction to be related to SHINGRIX.
Sex: F
Vaccine: DTAP
Symptoms: Local reaction
Clinical narrative: This case was reported by a nurse and described the occurrence of local reaction in a female patient who received INFANRIX (batch number PT2RK, expiry date 7th July 2019) for prophylaxis. In November 2017, the patient received INFANRIX. On an unknown date, less than a year after receiving Infanrix, the patient experienced local reaction. On an unknown date, the outcome of the local reaction was unknown. It was unknown if the reporter considered the local reaction to be related to INFANRIX. Additional details were provided as follows: The age at vaccination was not reported. The based on lot number provided, the suspect vaccine was captured as INFANRIX. The patient was a little girl who received the vaccine in November 2017 and got a localized reaction in her arm. The patient's mother was scared and worried about her receiving future vaccines. The reporter allergy office was attempting to figure out specific infomation on which Tdap vaccine one of patients had last November which caused a localized reaction. The patient's pediatrician's office provided us with the vaccine they administered in their office Tdap, they were writing to ask which GSK Tdap vaccine this was BOOSTRIX or one of other combo Tdap vaccines. No other information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Joint range of motion decreased, Myalgia
Clinical narrative: This case was reported by a consumer and described the occurrence of muscle pain in a male patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced muscle pain and joint range of motion decreased. On an unknown date, the outcome of the muscle pain and joint range of motion decreased were unknown. It was unknown if the reporter considered the muscle pain and joint range of motion decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the first shot experienced shoulder muscle pain in both arms limiting his range of motion. The patient was not happy with this lingering side effect. The patient reported that he would not be getting the 2nd dose of SHINGRIX.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Dizziness, Fatigue, Headache
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of chills in a adult female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced chills, stomach pain, headache, light headedness, tiredness and nerve pain. On an unknown date, the outcome of the chills, stomach pain, headache, light headedness, tiredness and nerve pain were recovered/resolved. It was unknown if the reporter considered the chills, stomach pain, headache, light headedness, tiredness and nerve pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. History was the patient's mom was sure her brother, sister and did not get chicken pots as kiddos, she had us go to too many chicken pox parties and she said they never got them. Within hours the patient had a stomachache, headache, light headed and had the chills. The next day same symptoms but also was very tired and had shooting pains in some of her nerves. All in all lasted about 48 hours. On a scale from one to ten, the patient was feeling like a six or seven we also almost did not go camping because I was concerned if I got worse there was no medical establishment within an hour and a half from where we were camping. But, by day three the patient was almost 100 percentage recovered. This case has been linked with US2018GSK107279, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of chills in a adult female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. In May 2018, less than a day after receiving SHINGRIX, the patient experienced chills, stomach pain, headache, light headedness, tiredness and nerve pain. On an unknown date, the outcome of the chills, stomach pain, headache, light headedness, tiredness and nerve pain were recovered/resolved. It was unknown if the reporter considered the chills, stomach pain, headache, light headedness, tiredness and nerve pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. History was the patient's mom was sure her brother, sister and did not get chicken pots as kiddos, she had us go to too many chicken pox parties and she said they never got them. Within hours the patient had a stomachache, headache, light headed and had the chills. The next day same symptoms but also was very tired and had shooting pains in some of her nerves. All in all lasted about 48 hours. On a scale from one to ten, the patient was feeling like a six or seven we also almost did not go camping because I was concerned if I got worse there was no medical establishment within an hour and a half from where we were camping. But, by day three the patient was almost 100 percentage recovered. This case has been linked with US2018GSK107279, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: This case was reported by a consumer and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 5th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a day after receiving SHINGRIX, the patient experienced headache, generalized muscle aches, pain, fever, tiredness, injection site pain, injection site swelling and poor sleep. On an unknown date, the outcome of the headache, generalized muscle aches, pain, fever, tiredness, injection site swelling and poor sleep were unknown and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the headache, generalized muscle aches, pain, fever, tiredness, injection site pain, injection site swelling and poor sleep to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 4:00 pm, on Tuesday, the patient received SHINGRIX. Wednesday, when the patient woke up, she was experiencing headache, whole body muscle pain, poor sleep (woke up due to pain and fever), tiredness, (the typical viral infection symptoms) with injection site reactions (pain, swelling, tenderness). The patient was still experiencing the above side effects till the time of reporting and the pain symptoms were getting better. As per reporter the event headache was from 7 to 2, and muscle pain was from 6 to 4 (NRS 11 scale).
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Poor quality sleep, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of headache in a female patient who received SHINGRIX for prophylaxis. On 5th June 2018, the patient received the 1st dose of SHINGRIX. In June 2018, less than a day after receiving SHINGRIX, the patient experienced headache, generalized muscle aches, pain, fever, tiredness, injection site pain, injection site swelling and poor sleep. On an unknown date, the outcome of the headache, generalized muscle aches, pain, fever, tiredness, injection site swelling and poor sleep were unknown and the outcome of the injection site pain was recovering/resolving. It was unknown if the reporter considered the headache, generalized muscle aches, pain, fever, tiredness, injection site pain, injection site swelling and poor sleep to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. At 4:00 pm, on Tuesday, the patient received SHINGRIX. Wednesday, when the patient woke up, she was experiencing headache, whole body muscle pain, poor sleep (woke up due to pain and fever), tiredness, (the typical viral infection symptoms) with injection site reactions (pain, swelling, tenderness). The patient was still experiencing the above side effects till the time of reporting and the pain symptoms were getting better. As per reporter the event headache was from 7 to 2, and muscle pain was from 6 to 4 (NRS 11 scale).
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Nausea, Pyrexia, Swelling
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a female patient who received SHINGRIX for prophylaxis. 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 injection site pain, fever, nausea, swelling and erythema. On an unknown date, the outcome of the injection site pain, fever, nausea, swelling and erythema were unknown. It was unknown if the reporter considered the injection site pain, fever, nausea, swelling and erythema to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported the adverse event to their provider. The patient experienced fever, nausea, swelling, redness, local injection site pain as a result missed 2 days of work.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a nurse and described the occurrence of rash in a 62-year-old female patient who received SHINGRIX (batch number ZY3X4, expiry date 28th April 2020) for prophylaxis. On 7th May 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 7th May 2018, less than a day after receiving SHINGRIX, the patient experienced rash. The patient was treated with Hydrocortisone 1% and BENADRYL. On 11th May 2018, the outcome of the rash was recovered/resolved. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: After vaccination with SHINGRIX, the patient experienced rash on both the arms with no itching and no pain. The patient was taken Hydrocortisone cream 1 percentage, and took 50 mg of BENADRYL. This case was linked to US2018GSK102821, reported by the same reporter for different patient.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Influenza like illness, Malaise, Nausea, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 50-year-old female patient who received SHINGRIX for prophylaxis. On 6th June 2018, the patient received SHINGRIX. In June 2018, less than a week after receiving SHINGRIX, the patient experienced nausea, pain in arm, exhaustion, feeling unwell and influenza like illness. On an unknown date, the outcome of the nausea, pain in arm, exhaustion, feeling unwell and influenza like illness were unknown. It was unknown if the reporter considered the nausea, pain in arm, exhaustion, feeling unwell and influenza like illness to be related to SHINGRIX. Additional details were provided as follows: The patient would be 51 years old in August 2018. The patient had a SHINGRIX vaccine and assumed her arm would hurt and it did in a big way, but the nausea was ridiculous, she was exhausted, felt sick, almost like the flu and it was horrible. The patient asked that how long did this event would usually last.  At the reporting time, the patient was at the work and was barely making it. She asked if the 2nd vaccine (booster) would be as bad as this. This was horrible and terrible. The patient was embarrassed that she might have to tell her boss that she had to go home due to a vaccine, which was terrible.
Sex: M
Vaccine: FLU4
Symptoms: Hyperhidrosis, Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in an adult male patient who received Influenza vaccine Quadrivalent for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On an unknown date, less than a day after receiving Influenza vaccine Quadrivalent, the patient experienced general body pain, fever and heavy sweating. On an unknown date, the outcome of the general body pain, fever and heavy sweating were unknown. It was unknown if the reporter considered the general body pain, fever and heavy sweating to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not provided. The patient reported that he received the Flu vaccine (unknown manufacturer) at his place of employment around in 1958. He got Flu shot at office, and then had to drive somewhere, so he left. Sometime during the night he pulled over to sleep, when he woke up he and the interior of the truck was dripping with water, and he felt like someone had beat him up with a baseball bat. He was achy all over. He thought he must have had a fever, and that is why everything was wet. He saw his physician afterwards and was told to never get the Flu shot again. The patient said a nurse called and spoke with someone for a long time about his experience with the Flu vaccine. When the nurse came back, she provided him with GlaxoSmithKline number and said someone with the company wanted to talk with him, so he called GlaxoSmithKline.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of pain in arm in a adult female patient who received Shingrix for prophylaxis. On an unknown date, the patient received the 1st dose of Shingrix .5 ml. On an unknown date, less than a year after receiving Shingrix, the patient experienced pain in arm, fever and influenza-like symptoms. On an unknown date, the outcome of the pain in arm, fever and influenza-like symptoms were recovering/resolving. It was unknown if the reporter considered the pain in arm, fever and influenza-like symptoms to be related to Shingrix. Additional information was received as follows: The age at vaccination was not reported. The patient felt soreness up and down her arm. The reporter stated that additionally, it felt like a fever blister on mouth coming but it never came. The patient felt better 4th day after adverse events. The patient would like for someone to call as she was very concerned about taking the 2nd dose of Shingrix.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site warmth in a 63-year-old female patient who received Shingrix for prophylaxis. Previously administered products included Shingrix with an associated reaction of lethargy (1st dose received in March 2018 and experienced achy (refer case US2018100619)). On 4th June 2018, the patient received the 2nd dose of Shingrix. On 4th June 2018, less than a day after receiving Shingrix, the patient experienced injection site warmth, injection site erythema and swelling arm. In June 2018, the patient experienced pain in arm. On an unknown date, the outcome of the injection site warmth, injection site erythema and swelling arm were recovering/resolving and the outcome of the pain in arm was unknown. It was unknown if the reporter considered the injection site warmth, injection site erythema, pain in arm and swelling arm to be related to Shingrix. Additional details were provided as follows: This case was previously reported to physician. The patient received dose two on June 4th around 11 Am. The patient was given both doses in the left arm. The patient reported that she felt hot at injection site, redness, and swelling. In June 2018, less than a week after vaccination, the patient experienced arm soreness. The patient reported that a circle of about 2 inches in diameter appeared the next day at the injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of stinging 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 year after receiving Shingrix, the patient experienced stinging. On an unknown date, the outcome of the stinging was unknown. The reporter considered the stinging to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported. The patient did not require any intervention, hospitalization, emergency room or physician visit, and the symptoms were not considered life threatening or disabling. For tolerance to next dose, refer case US2018102505.
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of pain in arm in a adult male patient who received Shingrix for prophylaxis. In May 2018, 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. 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 age at vaccination was not reported. The patient had only sore arm which was normal. This case has been linked with US2018GSK101943, reported by the same reporter.
Sex: F
Vaccine: FLU4, VARZOS, FLUX, VARZOS
Symptoms: Chills, Malaise, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of feeling unwell in a adult female patient who received Shingrix for prophylaxis. Concomitant products included Influenza vaccine Quadrivalent unspecified season. 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 feeling unwell, shivering and general body pain. On an unknown date, the outcome of the feeling unwell, shivering and general body pain were recovered/resolved. It was unknown if the reporter considered the feeling unwell, shivering and general body pain to be related to Shingrix. Additional details were provided as follows: The age at vaccination was not reported, but it could be either 57 or 58 year old. This case has been linked with US2018102471, reported by the same reporter for 2nd dose.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Impaired work ability, Influenza like illness, Lethargy
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (and fatigue, general body pain, fever, shivering, influenza-like symptoms and inability to work after receiving 1st dose, see case US2018049750). On 6th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th June 2018, 10 hrs after receiving SHINGRIX, the patient experienced fever, chills, general body pain, lethargy and urinary frequency. On an unknown date, the outcome of the fever, chills, general body pain, lethargy and urinary frequency were not recovered/not resolved. It was unknown if the reporter considered the fever, chills, general body pain, lethargy and urinary frequency to be related to SHINGRIX. Additional information was reported as follows: The patient had frequent urination for 4 hours and had fever of 101 degree F. The patient had no dysuria or no urgency. The follow up was not requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pollakiuria, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 65-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (and fatigue, general body pain, fever, shivering, influenza-like symptoms and inability to work after receiving 1st dose, see case US2018049750). On 6th June 2018, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 6th June 2018, 10 hrs after receiving SHINGRIX, the patient experienced fever, chills, general body pain, lethargy and urinary frequency. On an unknown date, the outcome of the fever, chills, general body pain, lethargy and urinary frequency were not recovered/not resolved. It was unknown if the reporter considered the fever, chills, general body pain, lethargy and urinary frequency to be related to SHINGRIX. Additional information was reported as follows: The patient had frequent urination for 4 hours and had fever of 101 degree F. The patient had no dysuria or no urgency. The follow up was not requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Joint swelling, Peripheral swelling, Urticaria
Clinical narrative: Patient stated having a welt and fairly huge swelling at injection site. The swelling advanced to her right shoulders and arms, thumb, ankle, wrist and  knuckles. Patient went to the emergency room  on 06/17/2018 and was given DECADRON 8mg to last 5 days.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: Site reaction (L) deltoid; positive edema, positive erythema, positive induration, positive warmth to palpation.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Breast discomfort, Decreased appetite, Fatigue, Pain
Clinical narrative: Generalized aching, diminished appetite, joints tender, fatigue "severe", skin sore to touch, breast discomfort; Sx subsided by 6-17-18 A.M..
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin
Clinical narrative: Generalized aching, diminished appetite, joints tender, fatigue "severe", skin sore to touch, breast discomfort; Sx subsided by 6-17-18 A.M..
Age: 42.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site nodule, Injection site pruritus, Paraesthesia
Clinical narrative: Severe tingling in both feet, both hands, for 4 days, that spread into legs and arms on the last day before it subsided. Also had large knot and itching at site of injection for 8 days.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Dysstasia, Headache, Insomnia, Muscular weakness
Clinical narrative: Patient states she started having adverse events to vaccine the evening after she had received it. She developed a headache and reports unable to sleep. The next morning she states she had muscle weakness and difficulty standing, and dizziness. Arm pain after she received vaccine which she reports has continued but is getting better.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: Patient states she started having adverse events to vaccine the evening after she had received it. She developed a headache and reports unable to sleep. The next morning she states she had muscle weakness and difficulty standing, and dizziness. Arm pain after she received vaccine which she reports has continued but is getting better.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Blister, Erythema, Tenderness
Clinical narrative: BLISTERS, RED HURTS AT TOUCH. NO TREATMENT. MOTHER DOES NOT WANT CHILD TO GET SEEN.
Age: 19.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Blood glucose normal, Cold sweat, Electrocardiogram normal, Eye movement disorder, Loss of consciousness
Clinical narrative: Pt seated on exam table, witnessed to have eyes deviate (R) w/LOC and < 5 sec shaking, felt to be vasovagal/syncope, No sz. Alert after approximately 15 sec, clammy, emesis x 1, BP 86/54, glu 99, HR 30's Sent via EMS to local ED, monitored, N EKG. d/c to home.
Age: 19.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Syncope, Tremor, Vomiting
Clinical narrative: Pt seated on exam table, witnessed to have eyes deviate (R) w/LOC and < 5 sec shaking, felt to be vasovagal/syncope, No sz. Alert after approximately 15 sec, clammy, emesis x 1, BP 86/54, glu 99, HR 30's Sent via EMS to local ED, monitored, N EKG. d/c to home.
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Blindness, Blindness cortical, Guillain-Barre syndrome, Hallucination, visual
Clinical narrative: This is a literature case, initially received on 04-Jun-2018 and concerns a female patient of unspecified age. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, (reported as following recent influenza vaccination), the patient experienced ascending weakness. On an unspecified date, the patient was hospitalized and was treated for suspected acute inflammatory demyelinating polyradiculoneuropathy (AIDP). Over the course of hospitalization, the patient experienced a progressive loss of vision which led to cortical blindness. During hospitalization, results of magnetic resonance imaging (MRI) were typical for posterior reversible encephalopathy syndrome (PRES), including scattered areas of cortical and subcortical T2 and T2 Flair hyperintensities within the occipital and parietal lobes. On an unspecified date, the patient's vision improved, but she experienced hallucinations including people changes in appearances, as well as objects around the room changing in size. At the time of this report, the outcome of the events was not reported. The reporter assessed the events as serious due to hospitalization. The reporter assessed the events as related to the suspect vaccine.
Sex: F
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Posterior reversible encephalopathy syndrome, White matter lesion
Clinical narrative: This is a literature case, initially received on 04-Jun-2018 and concerns a female patient of unspecified age. On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported). On an unspecified date, (reported as following recent influenza vaccination), the patient experienced ascending weakness. On an unspecified date, the patient was hospitalized and was treated for suspected acute inflammatory demyelinating polyradiculoneuropathy (AIDP). Over the course of hospitalization, the patient experienced a progressive loss of vision which led to cortical blindness. During hospitalization, results of magnetic resonance imaging (MRI) were typical for posterior reversible encephalopathy syndrome (PRES), including scattered areas of cortical and subcortical T2 and T2 Flair hyperintensities within the occipital and parietal lobes. On an unspecified date, the patient's vision improved, but she experienced hallucinations including people changes in appearances, as well as objects around the room changing in size. At the time of this report, the outcome of the events was not reported. The reporter assessed the events as serious due to hospitalization. The reporter assessed the events as related to the suspect vaccine.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site discolouration, Injection site warmth
Clinical narrative: Yellow discoloration, bruising around injection site, warm to touch in first few days of administration, slight bruising shown to pharmacist on 6/16/18.
Age: 21.0
Sex: F
Vaccine: HEP
Symptoms: Dyspnoea, Swelling face, Urticaria
Clinical narrative: Employee reported hives all over body, facial swelling, and shortness of breath that started Saturday midday after receiving the Hep B vaccine on Friday afternoon. Employee took oral BENADRYL around the clock until symptoms resolved late Sunday.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash vesicular
Clinical narrative: PATIENT HAD PAIN AND A ZOSTER LIKE LESION IN THE BACK. THE LESION DISAPPEARS IN 48 HOURS.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Crying, Dizziness
Clinical narrative: TOOK 400 MG IBUPROFEN AND WENT TO BED AT 10:30 P.M. GOT UP TO USE THE RESTROOM AT 2:30 A.M. AND FELT NORMAL. WOKE UP AT 4:30 A.M. TO USE THE RESTROOM AND BEGAN TO EXPERIENCE EXTREME DIZZINESS AND WEAKNESS. MY HUSBAND AWOKE FROM HEARING ME CRY OUT AND TOSSING/TURNING IN BED. THE ROOM WAS SPINNING AND I FELT NAUSEATED. I TRIED TO GET OUT OF BED, BUT AS SOON AS I SAT UP I FLOPPED BACK ONTO THE BED. MY HEAD FELT VERY HEAVY AND UNSTABLE. AT THIS POINT I KNEW I COULDN'T WALK ALONE AND ASKED FOR MY HUSBAND'S HELP. I WRAPPED MYSELF AROUND MY HUSBAND'S BACK AS HE WALKED ME VERY SLOWLY TO THE RESTOOM. I FELT EXTREME FATIGUE, VERY WEAK, AND THOUGHT I WAS GOING TO COLLAPSE. MY HUSBAND HELPED ME BACK TO BED. AT THIS POINT THE CHILLS AND SEVERE JOINT PAIN SET IN MOST NOTICEBLY IN MY LOWER BACK AND KNEES. THE INJECTION SITE ON MY LEFT ARM WAS SWOLLEN, HARD, VERY PAINFUL AND TENDER. I SLEPT UNTIL 10:00 A.M.  MY HUSBAND HELPED ME OUT OF BED AND INTO THE LIVING ROOM. I TOOK ANOTHER 400 MG OF IBUPROFEN AND USED A HEAT COMPRESS TO HELP ALLEVIATE THE CHILLS, JOINT PAIN, HEADACHE, AND SINUS PRESSURE. I TOOK SEVERAL NAPS AND RESTED ON THE COUCH THROUGHOUT THE DAY. I ATE LIGHT MEALS AND DRANK COFFEE/WATER. THE DIZZINESS IMPROVED AS THE DAY PROGRESSED; HOWEVER, THE EXTREME FATIGUE AND WEAKNESS LINGERED. LATER IN THE DAY I WAS ABLE TO GET UP AND WALK ON MY OWN WHILE HOLDING ON TO FURNITURE. I WENT TO BED AT 10 P.M. AND CONTINUED TO TAKE IBUPROFEN AND USE THE HEAT COMPRESS FOR JOINT PAIN. MY SECOND NIGHT AFTER THE INJECTION WAS BETTER. I EXPERIENCED SOME DIZZINESS, BUT WAS ABLE TO GET UP ON MY OWN AND USE THE RESTROOM. THE INJECTION SITE WAS STILL VERY PAINFUL AND HARD TO SLEEP ON. I FOUND THAT SLEEPING ON MY BACK SEEMED TO TRIGGER THE DIZZINESS, SO SLEPT ON MY RIGHT SIDE. WOKE UP ON THE SECOND DAY AFTER THE INJECTION AND WAS ABLE TO MOVE AROUND MYSELF WITH MORE EASE. THE WEAKNESS WAS GONE, BUT STILL FELT SOME FATIGUE. I WAS ABLE TO GET DRESSED AND GET READY FOR THE DAY. AS THE DAY PROGRESSED I WAS ABLE TO PERFORM SOME NORMAL ACTIVITIES, I.E. CLEANING AND WASHING CLOTHES. BY THE END OF THE DAY I WAS FEELING 95% BACK TO NORMAL WITH MINIMAL JOINT PAIN AND INJECTION SITE DISCOMFORT. THE THIRD NIGHT AFTER THE INJECTION WAS VERY RESTFUL. I DID EXPERIENCE SOME DIZZINESS DURING THE NIGHT AS IT SEEMED TO REAPPEAR WHEN I LAID ON MY BACK. I NOW FEEL 99% BACK TO NORMAL WITH SOME LINGERING DISCOMFORT AT THE INJECTION SITE.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Head discomfort, Headache, Injection site discomfort, Injection site induration
Clinical narrative: TOOK 400 MG IBUPROFEN AND WENT TO BED AT 10:30 P.M. GOT UP TO USE THE RESTROOM AT 2:30 A.M. AND FELT NORMAL. WOKE UP AT 4:30 A.M. TO USE THE RESTROOM AND BEGAN TO EXPERIENCE EXTREME DIZZINESS AND WEAKNESS. MY HUSBAND AWOKE FROM HEARING ME CRY OUT AND TOSSING/TURNING IN BED. THE ROOM WAS SPINNING AND I FELT NAUSEATED. I TRIED TO GET OUT OF BED, BUT AS SOON AS I SAT UP I FLOPPED BACK ONTO THE BED. MY HEAD FELT VERY HEAVY AND UNSTABLE. AT THIS POINT I KNEW I COULDN'T WALK ALONE AND ASKED FOR MY HUSBAND'S HELP. I WRAPPED MYSELF AROUND MY HUSBAND'S BACK AS HE WALKED ME VERY SLOWLY TO THE RESTOOM. I FELT EXTREME FATIGUE, VERY WEAK, AND THOUGHT I WAS GOING TO COLLAPSE. MY HUSBAND HELPED ME BACK TO BED. AT THIS POINT THE CHILLS AND SEVERE JOINT PAIN SET IN MOST NOTICEBLY IN MY LOWER BACK AND KNEES. THE INJECTION SITE ON MY LEFT ARM WAS SWOLLEN, HARD, VERY PAINFUL AND TENDER. I SLEPT UNTIL 10:00 A.M.  MY HUSBAND HELPED ME OUT OF BED AND INTO THE LIVING ROOM. I TOOK ANOTHER 400 MG OF IBUPROFEN AND USED A HEAT COMPRESS TO HELP ALLEVIATE THE CHILLS, JOINT PAIN, HEADACHE, AND SINUS PRESSURE. I TOOK SEVERAL NAPS AND RESTED ON THE COUCH THROUGHOUT THE DAY. I ATE LIGHT MEALS AND DRANK COFFEE/WATER. THE DIZZINESS IMPROVED AS THE DAY PROGRESSED; HOWEVER, THE EXTREME FATIGUE AND WEAKNESS LINGERED. LATER IN THE DAY I WAS ABLE TO GET UP AND WALK ON MY OWN WHILE HOLDING ON TO FURNITURE. I WENT TO BED AT 10 P.M. AND CONTINUED TO TAKE IBUPROFEN AND USE THE HEAT COMPRESS FOR JOINT PAIN. MY SECOND NIGHT AFTER THE INJECTION WAS BETTER. I EXPERIENCED SOME DIZZINESS, BUT WAS ABLE TO GET UP ON MY OWN AND USE THE RESTROOM. THE INJECTION SITE WAS STILL VERY PAINFUL AND HARD TO SLEEP ON. I FOUND THAT SLEEPING ON MY BACK SEEMED TO TRIGGER THE DIZZINESS, SO SLEPT ON MY RIGHT SIDE. WOKE UP ON THE SECOND DAY AFTER THE INJECTION AND WAS ABLE TO MOVE AROUND MYSELF WITH MORE EASE. THE WEAKNESS WAS GONE, BUT STILL FELT SOME FATIGUE. I WAS ABLE TO GET DRESSED AND GET READY FOR THE DAY. AS THE DAY PROGRESSED I WAS ABLE TO PERFORM SOME NORMAL ACTIVITIES, I.E. CLEANING AND WASHING CLOTHES. BY THE END OF THE DAY I WAS FEELING 95% BACK TO NORMAL WITH MINIMAL JOINT PAIN AND INJECTION SITE DISCOMFORT. THE THIRD NIGHT AFTER THE INJECTION WAS VERY RESTFUL. I DID EXPERIENCE SOME DIZZINESS DURING THE NIGHT AS IT SEEMED TO REAPPEAR WHEN I LAID ON MY BACK. I NOW FEEL 99% BACK TO NORMAL WITH SOME LINGERING DISCOMFORT AT THE INJECTION SITE.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Insomnia, Nausea, Paranasal sinus discomfort
Clinical narrative: TOOK 400 MG IBUPROFEN AND WENT TO BED AT 10:30 P.M. GOT UP TO USE THE RESTROOM AT 2:30 A.M. AND FELT NORMAL. WOKE UP AT 4:30 A.M. TO USE THE RESTROOM AND BEGAN TO EXPERIENCE EXTREME DIZZINESS AND WEAKNESS. MY HUSBAND AWOKE FROM HEARING ME CRY OUT AND TOSSING/TURNING IN BED. THE ROOM WAS SPINNING AND I FELT NAUSEATED. I TRIED TO GET OUT OF BED, BUT AS SOON AS I SAT UP I FLOPPED BACK ONTO THE BED. MY HEAD FELT VERY HEAVY AND UNSTABLE. AT THIS POINT I KNEW I COULDN'T WALK ALONE AND ASKED FOR MY HUSBAND'S HELP. I WRAPPED MYSELF AROUND MY HUSBAND'S BACK AS HE WALKED ME VERY SLOWLY TO THE RESTOOM. I FELT EXTREME FATIGUE, VERY WEAK, AND THOUGHT I WAS GOING TO COLLAPSE. MY HUSBAND HELPED ME BACK TO BED. AT THIS POINT THE CHILLS AND SEVERE JOINT PAIN SET IN MOST NOTICEBLY IN MY LOWER BACK AND KNEES. THE INJECTION SITE ON MY LEFT ARM WAS SWOLLEN, HARD, VERY PAINFUL AND TENDER. I SLEPT UNTIL 10:00 A.M.  MY HUSBAND HELPED ME OUT OF BED AND INTO THE LIVING ROOM. I TOOK ANOTHER 400 MG OF IBUPROFEN AND USED A HEAT COMPRESS TO HELP ALLEVIATE THE CHILLS, JOINT PAIN, HEADACHE, AND SINUS PRESSURE. I TOOK SEVERAL NAPS AND RESTED ON THE COUCH THROUGHOUT THE DAY. I ATE LIGHT MEALS AND DRANK COFFEE/WATER. THE DIZZINESS IMPROVED AS THE DAY PROGRESSED; HOWEVER, THE EXTREME FATIGUE AND WEAKNESS LINGERED. LATER IN THE DAY I WAS ABLE TO GET UP AND WALK ON MY OWN WHILE HOLDING ON TO FURNITURE. I WENT TO BED AT 10 P.M. AND CONTINUED TO TAKE IBUPROFEN AND USE THE HEAT COMPRESS FOR JOINT PAIN. MY SECOND NIGHT AFTER THE INJECTION WAS BETTER. I EXPERIENCED SOME DIZZINESS, BUT WAS ABLE TO GET UP ON MY OWN AND USE THE RESTROOM. THE INJECTION SITE WAS STILL VERY PAINFUL AND HARD TO SLEEP ON. I FOUND THAT SLEEPING ON MY BACK SEEMED TO TRIGGER THE DIZZINESS, SO SLEPT ON MY RIGHT SIDE. WOKE UP ON THE SECOND DAY AFTER THE INJECTION AND WAS ABLE TO MOVE AROUND MYSELF WITH MORE EASE. THE WEAKNESS WAS GONE, BUT STILL FELT SOME FATIGUE. I WAS ABLE TO GET DRESSED AND GET READY FOR THE DAY. AS THE DAY PROGRESSED I WAS ABLE TO PERFORM SOME NORMAL ACTIVITIES, I.E. CLEANING AND WASHING CLOTHES. BY THE END OF THE DAY I WAS FEELING 95% BACK TO NORMAL WITH MINIMAL JOINT PAIN AND INJECTION SITE DISCOMFORT. THE THIRD NIGHT AFTER THE INJECTION WAS VERY RESTFUL. I DID EXPERIENCE SOME DIZZINESS DURING THE NIGHT AS IT SEEMED TO REAPPEAR WHEN I LAID ON MY BACK. I NOW FEEL 99% BACK TO NORMAL WITH SOME LINGERING DISCOMFORT AT THE INJECTION SITE.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Sleep disorder
Clinical narrative: TOOK 400 MG IBUPROFEN AND WENT TO BED AT 10:30 P.M. GOT UP TO USE THE RESTROOM AT 2:30 A.M. AND FELT NORMAL. WOKE UP AT 4:30 A.M. TO USE THE RESTROOM AND BEGAN TO EXPERIENCE EXTREME DIZZINESS AND WEAKNESS. MY HUSBAND AWOKE FROM HEARING ME CRY OUT AND TOSSING/TURNING IN BED. THE ROOM WAS SPINNING AND I FELT NAUSEATED. I TRIED TO GET OUT OF BED, BUT AS SOON AS I SAT UP I FLOPPED BACK ONTO THE BED. MY HEAD FELT VERY HEAVY AND UNSTABLE. AT THIS POINT I KNEW I COULDN'T WALK ALONE AND ASKED FOR MY HUSBAND'S HELP. I WRAPPED MYSELF AROUND MY HUSBAND'S BACK AS HE WALKED ME VERY SLOWLY TO THE RESTOOM. I FELT EXTREME FATIGUE, VERY WEAK, AND THOUGHT I WAS GOING TO COLLAPSE. MY HUSBAND HELPED ME BACK TO BED. AT THIS POINT THE CHILLS AND SEVERE JOINT PAIN SET IN MOST NOTICEBLY IN MY LOWER BACK AND KNEES. THE INJECTION SITE ON MY LEFT ARM WAS SWOLLEN, HARD, VERY PAINFUL AND TENDER. I SLEPT UNTIL 10:00 A.M.  MY HUSBAND HELPED ME OUT OF BED AND INTO THE LIVING ROOM. I TOOK ANOTHER 400 MG OF IBUPROFEN AND USED A HEAT COMPRESS TO HELP ALLEVIATE THE CHILLS, JOINT PAIN, HEADACHE, AND SINUS PRESSURE. I TOOK SEVERAL NAPS AND RESTED ON THE COUCH THROUGHOUT THE DAY. I ATE LIGHT MEALS AND DRANK COFFEE/WATER. THE DIZZINESS IMPROVED AS THE DAY PROGRESSED; HOWEVER, THE EXTREME FATIGUE AND WEAKNESS LINGERED. LATER IN THE DAY I WAS ABLE TO GET UP AND WALK ON MY OWN WHILE HOLDING ON TO FURNITURE. I WENT TO BED AT 10 P.M. AND CONTINUED TO TAKE IBUPROFEN AND USE THE HEAT COMPRESS FOR JOINT PAIN. MY SECOND NIGHT AFTER THE INJECTION WAS BETTER. I EXPERIENCED SOME DIZZINESS, BUT WAS ABLE TO GET UP ON MY OWN AND USE THE RESTROOM. THE INJECTION SITE WAS STILL VERY PAINFUL AND HARD TO SLEEP ON. I FOUND THAT SLEEPING ON MY BACK SEEMED TO TRIGGER THE DIZZINESS, SO SLEPT ON MY RIGHT SIDE. WOKE UP ON THE SECOND DAY AFTER THE INJECTION AND WAS ABLE TO MOVE AROUND MYSELF WITH MORE EASE. THE WEAKNESS WAS GONE, BUT STILL FELT SOME FATIGUE. I WAS ABLE TO GET DRESSED AND GET READY FOR THE DAY. AS THE DAY PROGRESSED I WAS ABLE TO PERFORM SOME NORMAL ACTIVITIES, I.E. CLEANING AND WASHING CLOTHES. BY THE END OF THE DAY I WAS FEELING 95% BACK TO NORMAL WITH MINIMAL JOINT PAIN AND INJECTION SITE DISCOMFORT. THE THIRD NIGHT AFTER THE INJECTION WAS VERY RESTFUL. I DID EXPERIENCE SOME DIZZINESS DURING THE NIGHT AS IT SEEMED TO REAPPEAR WHEN I LAID ON MY BACK. I NOW FEEL 99% BACK TO NORMAL WITH SOME LINGERING DISCOMFORT AT THE INJECTION SITE.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site warmth
Clinical narrative: WARM FIRM ERYTHEMATOUS EDEMATOUS AREA APPROX 2" DIAMETER ON RIGHT LATERAL UPPER THIGH AT INJECTION SITE.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAY-2018, the patient was vaccinated with an improperly stored dose of PROQUAD rHA, lot # R002937, expiration date 29-JUL-2019 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion between -14 to -10 degrees Celsius for 25 minutes. Digital data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA007385: US-009507513-1806USA007386: US-009507513-1806USA007387: US-009507513-1806USA007388: US-009507513-1806USA007389: US-009507513-1806USA007390: US-009507513-1806USA007391: US-009507513-1806USA007392: US-009507513-1806USA007393.
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 30-year-old female patient. There was no information about the patient's pertinent medical history, concomitant therapies or drug reactions and allergies provided. On 29-MAR-2018, the patient was vaccinated with the first dose of GARDASIL 9 injection (exact dose, route of administration, lot# and expiration date were not reported) for prophylaxis. No adverse effects reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a patient of unknown age and gender. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2016, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster. On an unknown date later in 2016, the patient was treated by a physician for a persistent vesicular rash, which was diagnosed as chronic herpes zoster, or shingles. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date in 2013, the patient was inoculated with the ZOSTAVAX (lot number, dosage and route of administration not provided) at a pharmacy, as recommended for routine adult health maintenance and for the prevention of shingles. The ZOSTAVAX did not prevent shingles as intended and the patient subsequently contracted a persistent strain of herpes zoster. On or about 04-NOV-2014, the patient was treated by a physician for a persistent and severe vesicular rash, which was diagnosed as herpes zoster dermatitis. The patient was prescribed erythromycin ointment for management of her painful symptoms. The outcome of the events is unknown. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long-term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.