chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain of skin
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 53-year-old male patient who received SHINGRIX for prophylaxis.  The patient's past medical history included migraine and cold sores. Concurrent medical conditions included attention deficit/hyperactivity disorder. Concomitant products included acyclovir, atorvastatin calcium (Atorvastatin), bupropion hydrochloride (Bupropion), lansoprazole, losartan potassium (Losartan) and metformin hydrochloride (Metformin). On 8th May 2018, the patient received the 1st dose of SHINRIX. On 8th May 2018, immediately after receiving SHINGRIX, the patient experienced influenza-like symptoms, loss of energy and feeling unwell. On 13th May 2018, the patient experienced scalp pain. On an unknown date, the patient experienced migraine. On an unknown date, the outcome of the influenza-like symptoms, scalp pain, migraine, loss of energy and feeling unwell were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, scalp pain, migraine, loss of energy and feeling unwell to be related to SHINGRIX. Additional information was received as follows: The patient did not feel so great immediately after receiving the SHINGRIX and he felt flu like symptoms with no energy. The patient stopped the acyclovir which he was taking for migraines, he had no migraines and no cold sores. The patient had denied permission to contact their physician. This case has been linked to the case US2018GSK124064, reported by the same reporter.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a 53-year-old male patient who received SHINGRIX for prophylaxis.  The patient's past medical history included migraine and cold sores. Concurrent medical conditions included attention deficit/hyperactivity disorder. Concomitant products included acyclovir, atorvastatin calcium (Atorvastatin), bupropion hydrochloride (Bupropion), lansoprazole, losartan potassium (Losartan) and metformin hydrochloride (Metformin). On 8th May 2018, the patient received the 1st dose of SHINRIX. On 8th May 2018, immediately after receiving SHINGRIX, the patient experienced influenza-like symptoms, loss of energy and feeling unwell. On 13th May 2018, the patient experienced scalp pain. On an unknown date, the patient experienced migraine. On an unknown date, the outcome of the influenza-like symptoms, scalp pain, migraine, loss of energy and feeling unwell were recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms, scalp pain, migraine, loss of energy and feeling unwell to be related to SHINGRIX. Additional information was received as follows: The patient did not feel so great immediately after receiving the SHINGRIX and he felt flu like symptoms with no energy. The patient stopped the acyclovir which he was taking for migraines, he had no migraines and no cold sores. The patient had denied permission to contact their physician. This case has been linked to the case US2018GSK124064, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Immediate post-injection reaction, Influenza like illness, Malaise, Migraine
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The reporter's friend of friend had an experience of feeling flu like symptoms after receiving SHINGRIX. This case has been linked to the case US2018120284, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain of skin
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The reporter's friend of friend had an experience of feeling flu like symptoms after receiving SHINGRIX. This case has been linked to the case US2018120284, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a adult patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional information was received as follows: The reporter's friend of friend had an experience of feeling flu like symptoms after receiving SHINGRIX. This case has been linked to the case US2018120284, reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Pain, Paraesthesia, Pyrexia, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 65-year-old female patient who received SHINGRIX (batch number 32GR4, expiry date 4th July 2020) for prophylaxis. On 12th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th June 2018, less than a day after receiving SHINGRIX, the patient experienced pain, fever, tingling of extremity, numbness of extremities and swelling. On an unknown date, the outcome of the pain, fever and swelling were recovered/resolved and the outcome of the tingling of extremity and numbness of extremities were not recovered/not resolved.  The reporter considered the pain, fever, tingling of extremity, numbness of extremities and swelling to be unlikely related to SHINGRIX. Additional information was received as follows: The patient received SHINGRIX on the right deltoid. The health care professional reported that the patient experienced pain, swelling, and fever soon after receiving the vaccine. The patient also experienced numbness and tingling in the hand and arm that lasted for about 2 days. This numbness and tingling went away and then came back several days later in hand and arm along with numbness and tingling in the feet. The patient might had communicated this to the physician about this. The patient explained the feeling as arm, hand, and feet falling asleep.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Lacrimation increased, Nasal congestion, Paraesthesia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tingling sensation in a 64-year-old female patient who received SHINGRIX for prophylaxis.  On 29th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 29th June 2018, less than an hour after receiving SHINGRIX, the patient experienced tingling sensation, watering eyes and nasal congestion. On an unknown date, the outcome of the tingling sensation, watering eyes and nasal congestion were not recovered/not resolved. It was unknown if the reporter considered the tingling sensation, watering eyes and nasal congestion to be related to SHINGRIX. Additional details were provided as follows: The patient received a dose of SHINGRIX in left arm. Within an hour the patient felt a tingly feeling in her nose, nasal congestion and her eyes were watery. The patient stated that the symptoms had not gotten any better and stated that she was not sick when before she received the vaccine.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Myalgia, Poor quality sleep, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 3rd July 2018 14:30, the patient received the 1st dose of SHINGRIX 50 mcg/mg. On 3rd July 2018 11:00, 8 hrs 30 min after receiving SHINGRIX, the patient experienced muscle pain, chills, fever and weakness. In July 2018, the patient experienced poor sleep. The patient was treated with naproxen (Aleve). In July 2018, the outcome of the poor sleep was recovered/resolved. On an unknown date, the outcome of the muscle pain, chills, fever and weakness were recovered/resolved. The reporter considered the muscle pain, chills, fever and weakness to be related to SHINGRIX. It was unknown if the reporter considered the poor sleep to be related to SHINGRIX. Additional details were provided as follows: The patient started to experience all the symptoms the evening after receiving the shot, the patient estimated it to be around 11:00 pm. Less than a day after receiving the SHINGRIX, the patient did not sleep well all night due to the symptoms. The patient took Aleve which helped with the aches. The symptoms started to resolve on 4th July 2018 (in the afternoon). The patient did not actually take her temperature but said she just felt feverish.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Peripheral coldness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 62-year-old male patient who received SHINGRIX for prophylaxis.  Concomitant products included rivaroxaban (Xarelto). On 2nd July 2018 15:30, the patient received the 1st dose of SHINGRIX (intramuscular) 50 mcg/mg. On 2nd July 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain and difficulty sleeping. On 3rd July 2018, the patient experienced cold feet. On an unknown date, the outcome of the injection site pain was recovering/resolving and the outcome of the difficulty sleeping was not reported and the outcome of the cold feet was not recovered/not resolved. It was unknown if the reporter considered the injection site pain, difficulty sleeping and cold feet to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX on the left arm. The patient stated that he started experiencing cold feet in both of his legs approximately 1 to 2 days after getting the SHINGRIX vaccine. Legs were not cold to touch but they felt cold for the patient. It has became more noticeable since the past 2 days from the date of this report. The patient also experienced pain at the injection site within one day of getting the vaccine, and was not able to sleep on the side of the arm due to pain. At the time of this report, the patient recovering from the pain.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Myalgia, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 1 day after receiving SHINGRIX, the patient experienced chills, muscle pain and fever. On an unknown date, the outcome of the chills, muscle pain and fever were recovered/resolved. The reporter considered the chills, muscle pain and fever to be related to SHINGRIX. Additional information was received as follows: This reporter is the aunt of the patient and she provided all the details she had. The age at vaccination was not reported. The patient had the vaccination a couple of months before the reporting date (in 2018) and experienced the side effects and they lasted approximately 24 hours before resolving. The patient had denied permission to contact their physician. The reporter did not want follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX (batch number 9779K, expiry date 24th May 2019) 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 pain in arm and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved. It was unknown if the reporter considered the pain in arm and tiredness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The HCP (healthcare professional) who was also the patient reported that they developed a sore arm and tiredness for four days after receiving their initial dose of SHINGRIX. No further information was reported regarding the event. This case has been linked with case US2018122189, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a adult female patient who received SHINGRIX (batch number 9779K, expiry date 24th May 2019) 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 pain in arm and tiredness. On an unknown date, the outcome of the pain in arm and tiredness were recovered/resolved. It was unknown if the reporter considered the pain in arm and tiredness to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the patient herself. The age at vaccination was not reported. The HCP (healthcare professional) who was also the patient reported that they developed a sore arm and tiredness for four days after receiving their initial dose of SHINGRIX. No further information was reported regarding the event. This case has been linked with case US2018122189, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Pain in extremity
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm 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 pain in arm and welts. On an unknown date, the outcome of the pain in arm and welts were unknown. It was unknown if the reporter considered the pain in arm and welts to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient developed a sore arm and welt after receiving a dose of SHINGRIX in series. No further information was reported regarding the event. The healthcare professional stated that she did not want to provide further details regarding the event as she did not have the patient's consent to do so. This case has been linked with case US2018122175, reported by the same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm 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 pain in arm and welts. On an unknown date, the outcome of the pain in arm and welts were unknown. It was unknown if the reporter considered the pain in arm and welts to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The healthcare professional reported that the patient developed a sore arm and welt after receiving a dose of SHINGRIX in series. No further information was reported regarding the event. The healthcare professional stated that she did not want to provide further details regarding the event as she did not have the patient's consent to do so. This case has been linked with case US2018122175, reported by the same reporter.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Induration, Nodule, Pruritus
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of localized itching in a 64-year-old male patient who received SHINGRIX for prophylaxis. Concurrent medical conditions included injection site induration (at Enbrel injection sites), injection site itching (at Enbrel injection sites) and injection site nodule (at Enbrel injection sites). Concomitant products included etanercept (Enbrel). On 6th April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving Shingrix, the patient experienced localized itching, induration, nodule and condition aggravated. On an unknown date, the outcome of the localized itching, induration, nodule and condition aggravated were unknown. It was unknown if the reporter considered the localized itching, induration, nodule and condition aggravated to be related to SHINGRIX. Additional details were received as follows: The patient was taking Enbrel once a week 50 mg a week. The patient got SHINGRIX vaccine then got hard itchy nodules at Enbrel injection sites following SHINGRIX injection. The physician note says this got worse after SHINGRIX vaccination. The events might had occurred prior to vaccination but worsened after SHINGRIX vaccine. The duration of symptoms was 6 to 7 days after each Enbrel injection. The symptoms had not resolved. The reporter was unsure on if the patient had received 2nd dose of SHINGRIX shot.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a female patient who received SHINGRIX for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included milk allergy. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. The patient had a strong allergic reaction to the vaccine. The patient was trying to sleuth out what in the vaccine she had reacted to, as found this study which listed lactose as a stabilizer. The patient wanted to know what to do about follow up/booster shot. The patient  was exactly the cohort that was urged to get this vaccine. The patient wanted know could she get this SHINGRIX booster minus the lactose. The patient wanted to know why would you include one of the top 8 allergens in a vaccine as 15 million  to one or more of these. This case was linked to the case US2018GSK124082, reported by the same reporter.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Influenza like illness, Injection site pain, Pain
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of injection site pain in a 59-year-old female patient who received SHINGRIX for prophylaxis. Concomitant products included SHINGRIX. On 30th May 2018, the patient received the 2nd dose of SHINGRIX. On 30th May 2018, less than a day after receiving SHINGRIX, the patient experienced injection site pain, headache, general body pain and influenza like illness. The patient was treated with ibuprofen (Advil). On an unknown date, the outcome of the injection site pain, headache, general body pain and influenza like illness were unknown. It was unknown if the reporter considered the injection site pain, headache, general body pain and influenza like illness to be related to SHINGRIX. Additional details were provided as follows: On 27th March 2018, the patient received 1st dose of SHINGRIX. The patient experienced very painful at injection site, severe headache and body ache. The patient also felt like flu. The reporter did not agree to follow up.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Herpes zoster, Sciatica
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of shingles in a 84-year-old female patient who received SHINGRIX (batch number 9YD45, expiry date unknown) for prophylaxis. Previously administered products included ZOSTAVAX (received previously more than 10 years before the reporting date). On 26th June 2018, the patient received SHINGRIX .5 ml. On 26th June 2018, less than a day after receiving SHINGRIX, the patient experienced sciatica. On an unknown date, the patient experienced shingles and contusion. On an unknown date, the outcome of the shingles, sciatica and contusion were unknown. It was unknown if the reporter considered the shingles, sciatica and contusion to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on the left deltoid. The patient thought getting sciatica on the day of SHINGRIX vaccination or day before SHINGRIX vaccine administration. A few days after SHINGRIX vaccine administration, the patient believed getting bruise in buttocks. The patient came back to office and clearly had mild case of shingles on her left buttocks and down leg. The physician was unclear if the patient had case of shingles occurring prior to or because of SHINGRIX vaccine. The physician was unclear if events were related to SHINGRIX. The reporter agreed to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Injection site pain, Tremor
Clinical narrative: This case was reported by a consumer 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, chills and joint pain. On an unknown date, the outcome of the injection site pain and joint pain were unknown and the outcome of the chills was recovered/resolved. It was unknown if the reporter considered the injection site pain, chills and joint pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that she had never reacted to a vaccine before and had soreness at injection site that she expected but during the night she had 2 hours of shaking chills and her joints were extremely sore, even more sore than when she had joint replacement. The patient queried how long these side effects would last with SHINGRIX and the query was answered as the side affect from the SHINGRIX, according to the prescribing Information, could last 3 to 5 days and depends on the individual. The patient stated that this really made her not look forward to the second injection which she knew she had to receive.
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of swelling arm in a elderly 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 swelling arm, pain in arm and mobility decreased. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the swelling arm, pain in arm and mobility decreased were unknown. It was unknown if the reporter considered the swelling arm, pain in arm and mobility decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. It was reported that the patients arm swelled up significantly and the pain was substantial that she could not lift her arm, she called the physician office, she proceeded to go to the emergency room, they gave her antibiotics and cream. No other information was given to the physician office.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of injection site pain in an unspecified number of adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to SHINGRIX. Additional details were provided as follows: The patient's initials, gender and date of birth were unknown. The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. The reporting physician mentioned that the patients were complaining about pain at injection site post vaccination with SHINGRIX. The reporter did not agree to follow up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of 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 pain and feeling abnormal. On an unknown date, the outcome of the pain and feeling abnormal were unknown. It was unknown if the reporter considered the pain and feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. While discussing the side effects of SHINGRIX, the pharmacist stated that she had the patient stating that the vaccine hurt and it made the patient feel yucky. The patient worked with the pharmacist and stated that she did not think she would get the 2nd dose due to how bad it made her feel. The pharmacist told the patient that these were expected and this was how she would know that the vaccine was working. This case was linked with US2018GSK119913, reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Pain
Clinical narrative: This case was reported by a pharmacist via sales rep and described the occurrence of pain in about 8 adult patients who received SHINGRIX for prophylaxis. On an unknown date, the patients received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patients experienced pain and feeling abnormal. On an unknown date, the outcome of the pain and feeling abnormal were unknown. It was unknown if the reporter considered the pain and feeling abnormal to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was selected as adult as per vaccine indication. While discussing the side effects of SHINGRIX, the pharmacist stated that she had about 8 patients who had contacted her stating that the SHINGRIX vaccine hurt and it made them feel yucky. The pharmacist told these patients that these were expected and this was how they would know that the vaccine was working. The reporter did not agree to follow up. This case was linked with US2018GSK119910, reported by the same reporter.
Sex: M
Vaccine: MEN
Symptoms: Malaise
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.  On an unknown date, the patient received Meningococcal B vaccine at an unknown dose. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was not recovered/not resolved. It was unknown if the reporter considered the sickness to be related to Meningococcal B vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that her nephew got this shot and became very sick afterwards sometimes vaccines were not always safe her daughter got the same vaccine and was fine but the reporter thought people should be aware, the patient was still sick a year later information was available people should know.
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure increased, Heart rate increased, Nausea, Pyrexia
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of heart rate increased in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced heart rate increased, fever and nausea. On an unknown date, the outcome of the heart rate increased, fever and nausea were not recovered/not resolved. It was unknown if the reporter considered the heart rate increased, fever and nausea to be related to SHINGRIX. Additional details were provided as follow: This case was reported by the patient's daughter via social media. The age at vaccination was not reported. The reporter posted a serious post and stated that; do not let your parents or grandparents get the new Shingles vaccine that was supposed to be more effective. SHINGRIX landed the reporter's friend's mother in emergency room with very elevated heart rate and pressure, fever and nausea. Two weeks later, the patient was feeling theses things from time to time. The reporter stated that, anything that messes up the heart was not worthy. The reporter contacted her friend and she confirmed that the patient took SHINGRIX.
Sex: M
Vaccine: MENB
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of pain in arm in a male patient who received BEXSERO for prophylaxis. On an unknown date, the patient received the 2nd dose of BEXSERO. On an unknown date, unknown after receiving BEXSERO, the patient experienced pain in arm, swelling arm and fever. On an unknown date, the outcome of the pain in arm, swelling arm and fever were unknown. It was unknown if the reporter considered the pain in arm, swelling arm and fever to be related to BEXSERO.   Additional details were provided as follows:  The age at vaccination was not reported. The doctor stated that he gave his son the dose of Bexsero and experienced a sore arm for 3 days, also had swelling, and fever of 99.9 degree units.      Lab Comments: On an unknown date patient body temperature were recorded to be 99.9 units.
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity
Clinical narrative: This case was reported by a consumer and described the occurrence of allergic reaction in a female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis. The patient's past medical history included shingles. Concurrent medical conditions included milk allergy. On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season at an unknown dose. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown. It was unknown if the reporter considered the allergic reaction to be related to Influenza vaccine Quadrivalent unspecified season. Additional details were provided as follows: The age at the vaccination was not reported. The patient received FLUARIX vaccine last year. The patient had a strong allergic reaction to the vaccine. The patient could not find anywhere on the site the list of ingredients in FLUARIX. The patient suspected since GlaxoSmithKline made both of these they may use the same base of stabilizers as lactose. The patient wanted to know what she can do about a flu vaccine this year. The patient wanted to know does GlaxoSmithKline manufacture available vaccines without the top 8 Major Allergens. The patient also wanted information should be included in the disclosure of these allergens. This case was linked to the case US2018GSK118116, reported by the same patient.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Blood test, Herpes zoster, Rash vesicular, Scab
Clinical narrative: Information has been received from a 61 year old male patient with hypertension, type 2 diabetes mellitus, hypercholesterolaemia, drug hypersensitivity and sulfonamide allergy who in May 2008, was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included DIOVAN, NORVASC, metformin, CLARINEX and ezetimibe (plus) simvastatin (MSD). It was reported that "two weeks ago", approximately on 04-AUG-2009, the patient was diagnosed with shingles. The patient was evaluated by his physician and was advised to use topical Calamine Lotion. Unspecified blood test was performed on an unknown date (results not provided). The patient also stated that the lesions were "almost completely crusted over" at the time of the report. The patient was recovering at the time of reporting. Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2008, the patient was vaccinated with ZOSTAVAX, (lot number and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. Later in 2008 (previously reported as 04-AUG-2009), the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. 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. Sender's Comments: Merck 0908USA02991: Mfr number.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin lesion
Clinical narrative: Information has been received from a 61 year old male patient with hypertension, type 2 diabetes mellitus, hypercholesterolaemia, drug hypersensitivity and sulfonamide allergy who in May 2008, was vaccinated with a dose of zoster vaccine live (Oka/Merck). Concomitant therapy included DIOVAN, NORVASC, metformin, CLARINEX and ezetimibe (plus) simvastatin (MSD). It was reported that "two weeks ago", approximately on 04-AUG-2009, the patient was diagnosed with shingles. The patient was evaluated by his physician and was advised to use topical Calamine Lotion. Unspecified blood test was performed on an unknown date (results not provided). The patient also stated that the lesions were "almost completely crusted over" at the time of the report. The patient was recovering at the time of reporting. Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. In 2008, the patient was vaccinated with ZOSTAVAX, (lot number and route unknown) for routine adult health maintenance for the prevention of shingles. The vaccine did not prevent shingles as intended, and the patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX vaccine was intended to prevent. Later in 2008 (previously reported as 04-AUG-2009), the patient was treated at a medical center for a blistering vesicular outbreak, which was diagnosed as herpes zoster, or shingles. 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. Sender's Comments: Merck 0908USA02991: Mfr number.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Disorientation, Dysstasia, Electrocardiogram, Hyperhidrosis, Loss of consciousness
Clinical narrative: Member went pale, sweaty and then passed out. Had to be woken up with Ammonia Salt. Member was disoriented and unable to stand or sit up for 1 hr after vaccine.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Pallor, Posture abnormal
Clinical narrative: Member went pale, sweaty and then passed out. Had to be woken up with Ammonia Salt. Member was disoriented and unable to stand or sit up for 1 hr after vaccine.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site erythema, Injection site warmth, Nausea, Rash macular
Clinical narrative: Chills during day of injection and pain in upper left arm. Pain continued on 7/11. Woke up on 7/12/18 and had area of mild rash around injection site and a larger area of rash 2 inches below. All areas were hot to the touch. Have continued to have chills, but no fever. Some nausea and dizziness. Rapid heartbeat at times.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Dizziness, Heart rate increased, Injection site pain, Injection site rash
Clinical narrative: Chills during day of injection and pain in upper left arm. Pain continued on 7/11. Woke up on 7/12/18 and had area of mild rash around injection site and a larger area of rash 2 inches below. All areas were hot to the touch. Have continued to have chills, but no fever. Some nausea and dizziness. Rapid heartbeat at times.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Nausea
Clinical narrative: Chills during day of injection and pain in upper left arm. Pain continued on 7/11. Woke up on 7/12/18 and had area of mild rash around injection site and a larger area of rash 2 inches below. All areas were hot to the touch. Have continued to have chills, but no fever. Some nausea and dizziness. Rapid heartbeat at times.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Limb discomfort, Pyrexia, Vomiting
Clinical narrative: Day after vaccine received, patient developed fever, heaviness in arm, vomiting.
Age: 18.0
Sex: F
Vaccine: MNQ
Symptoms: Immediate post-injection reaction, Syncope
Clinical narrative: Pt experienced a syncopal event immediately following administration. Patient sustained no injuries and fully recovered w/in 15 minutes. Pt had not eaten morning of her appointment prior to receiving this vaccine.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphasia, Disturbance in attention, Feeling jittery, Muscle spasms, Speech disorder
Clinical narrative: Muscle spasms (sometimes in both arms), vomiting, jitters, concentration issues, forgetting of words and speech impediment.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Muscle spasms (sometimes in both arms), vomiting, jitters, concentration issues, forgetting of words and speech impediment.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Musculoskeletal pain, Pain in extremity
Clinical narrative: Rash near injection site, pain in upper arm and shoulder.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Chills, Headache, Nausea, Pyrexia
Clinical narrative: Patient stated that 10 to 12 hours after receiving the vaccine he experienced chills, a fever, light nausea and chest pain. The chest pain was so severe that he took a nitroglycerin tablet. Within 3 minutes of taking the nitroglycerin, the pain subsided. He then got a severe headache and went to his doctor for an office visit.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypophagia, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Redness/swelling near site and fever up to 102. Poor PO.
Age: 19.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Received the vaccine in our office around 4:30 pm and was told to wait by our staff to wait in the waiting room for 15 minutes to make sure that he had no reaction to the vaccine. Later that night his arm became swollen from his shoulder all the way to his hand. It was hot to the touch, red and very painful. His mother, Dr., appropriately treated the reaction at home and contacted Dr. yesterday, 7-12-18, and asked us to report the adverse reaction.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV9, MENB
Symptoms: Agitation, Discomfort, Dyspnoea, Pain in extremity, Throat tightness
Clinical narrative: Agitated, uncomfortable, possible hallucinations, short of breath, pain in extremities, throat closing.
Age: 44.0
Sex: M
Vaccine: HEPA
Symptoms: Ear pain, Lymphadenopathy, Oropharyngeal pain
Clinical narrative: Client reported Lymphadenopathy on the Left side of his neck along with having a sore throat, and ear pain. These signs and symptoms started approximately 10-12 hours after receiving the vaccine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Patient reports swollen arm with some erythema.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Contusion, Full blood count normal, Joint swelling, Lip swelling, Metabolic function test normal
Clinical narrative: Sudden onset of swelling of upper lip and swelling and bruising of feet and ankles. Few hours later developed red raised irregular itchy rash in groin area. Tenderness of his feet developed. Child was seen in ED. Symptoms started when they were traveling.
Age: 5.0
Sex: M
Vaccine: MMRV
Symptoms: Peripheral swelling, Rash erythematous, Rash pruritic, Tenderness, Urine analysis normal
Clinical narrative: Sudden onset of swelling of upper lip and swelling and bruising of feet and ankles. Few hours later developed red raised irregular itchy rash in groin area. Tenderness of his feet developed. Child was seen in ED. Symptoms started when they were traveling.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Inflammation, Pain in extremity, Pyrexia, Vomiting
Clinical narrative: Patient presented fever, vomit, headache and inflammation of right arm 20 min after vaccination. She took 1 tablet of TYLENOL the day of the vaccination. After 24 hours, patient presents inflammation and pain in right arm, symptoms improving.
Age: 0.25
Sex: F
Vaccine: IPV, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: MEDICAL ASSISTANT AFTER ADMINISTERING AND RUNNING VACCINE REPORT ADMINISTERED THE WRONG PNEUMO VACCINE. PNEUMO 13 WAS ORDERED BY PHYSICIIAN AND PNEUMO 23 WAS ADMINISTERED TO PATIENT IN ERROR. PT REPORTS NO SIGNS OR SYMPTOMS OR REACTIONS.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Balance disorder, Disorientation, Dysarthria, Inappropriate affect, Pain
Clinical narrative: He got PREVNAR shot on 7/10/18 at 7:30 pm and went to bed. Said he woke up around 11:00 am on 7/11/18 and went to another pharmacy to pick up his medications and he said he was slurring his speech and looked disoriented. He was off also balance and keep on laughing. Said he was like that til 5:00 pm 7/11/18. He said as of 7/12/18 those symptoms are gone except arm pain and some body ache.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: He got PREVNAR shot on 7/10/18 at 7:30 pm and went to bed. Said he woke up around 11:00 am on 7/11/18 and went to another pharmacy to pick up his medications and he said he was slurring his speech and looked disoriented. He was off also balance and keep on laughing. Said he was like that til 5:00 pm 7/11/18. He said as of 7/12/18 those symptoms are gone except arm pain and some body ache.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Influenza like illness, Injection site pain
Clinical narrative: About six hours after receiving the injection, the following symptoms, very similar to the "flu" occurred: Body aches, headache, upset stomach, slight fever, fatigue. Lasting overnight and half of the next day. Also, there was/is soreness at the injection site.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: About six hours after receiving the injection, the following symptoms, very similar to the "flu" occurred: Body aches, headache, upset stomach, slight fever, fatigue. Lasting overnight and half of the next day. Also, there was/is soreness at the injection site.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Musculoskeletal disorder, Myalgia, Pain in extremity
Clinical narrative: Patient reports she woke up on 6/28 with left arm pain. States it felt "internal" and throughout the entire "muscle system". Felt like she needed a sling. Couldn't move arm for the first three days, then gradually increased range of motion. No numbness/tingling, no problems grasping items. Currently unable to use the arm as she preciously could, can't put hair up or lift things. She called the clinic on 6/29/18, she was advised to have it evaluated. She called again 7/10/18 stating that it was still sore and was advised to be evaluated. Writer spoke with her today, 7/13/18, and advised that she have it evaluated in the next few days as she is still having symptoms and it has been three weeks since her vaccination.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Dizziness, Fatigue, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: Swollen, redness, burning and itching at injection site for over 2 days. Nausea, body aches, lightheadedness and extreme fatigue.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Injection site swelling, Nausea, Pain
Clinical narrative: Swollen, redness, burning and itching at injection site for over 2 days. Nausea, body aches, lightheadedness and extreme fatigue.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Blood test, Electroencephalogram, Lumbar puncture, Narcolepsy, Nuclear magnetic resonance imaging
Clinical narrative: Type 1 Narcolepsy.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Sleep study
Clinical narrative: Type 1 Narcolepsy.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Pallor
Clinical narrative: PATIENT RECEIVED 2 DIFFERENT IMMUNIZATIONS IN 2 DIFFERENT ARMS. RIGHT WAS TDAP AND LEFT WAS MENINGOCOCCAL. PATIENT HAD NO SIGNS OR SYMPTONS OF FEELING ILL WHEN LEAVING THE IMMUNIZATIONS ROOM. HE WENT TO SIT IN THE WAITING AREA WITH MOTHER AND BROTHER. THIS PERSON WALKED OUT THE DOOR TO CALL ANOTHER PATIENT BACK AND I LOOKED AT THE PATIENT AND SAW THAT HE WAS NOT LOOKING WELL AND LOST COLOR TO HIS FACE. THE MOTHER STATED "SHOULD HE LOOK LIKE THIS?" HE WAS THEN IMMEDIATELY BROUGHT BACK TO THE TREATMENT ROOM AND LAYED ON THE PATIENT BED WITH HIS FEET ELEVATED. AN ICE PACK WAS PLACED BEHIND HIS NECK. HE WAS ALSO GIVEN SOME ORANGE JUICE AND WAS ABLE TO SWALLOW AND TOLERATE IT WELL.  HIS PERSON THEN TOOK THE VITAL SIGNS AND GAVE THEM TO THE CLINIC NURSE. THE PATIENT HAD AN APPOINTMENT WITH HIS PRIMARY CARE MD TODAY AND WILL FOLLOW UP WITH HIM. HE REMAINED ON THE PATIENT BED FOR APPROXIMATELY 30 MIN AND MOTHER CAME BACK TO TAKE HIM TO HIS REGULARLY SCHEDULED APPOINTMENT. HE STATED HE WAS FEELING BETTER AND THE COLOR DID RETURN TO HIS FACE. HE THEN WALKED WITH HIS MOTHER AND BROTHER TO HIS APPOINTMENT IN ANOTHER CLINIC WITHIN THE HOSPITAL.