chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MENB
Symptoms: Blindness, Dyspnoea
Clinical narrative: This is a spontaneous report from a contactable other HCP via Pfizer sales representative. A 19-year-old female patient of an unspecified ethnicity received the first dose of TRUMENBA, at single dose and the first dose of tuberculin PPD, both via an unspecified route of administration on an unspecified date for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date, the patient experienced not being able to see with outcome of unknown, could not breath with outcome of recovered. Therapeutic measures were taken as a result of could not breath included an EPIPEN. The events were described as follows: Upon leaving the office while she was scheduling her week later follow up for PPD, at the checkout desk she complained of not being able to see. The doctor took her to the back exam room then she said she could not breathe. They called number but in the meantime the doctor administered an EPIPEN. She was OK after that. The information on the lot number has been requested. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators as appropriate.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX. On 11th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, fever, muscle pain, general body pain and headache. The patient was treated with KEFLEX and VICODIN. In April 2018, the outcome of the fever, muscle pain, general body pain and headache were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, fever, muscle pain, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on Wednesday at 4 to 11 about noon. On Wednesday, at 7:00 pm, the patient experienced muscle; all over body aches, very bad headache, fever and pain, swelling and redness (about 4 into 2, 1 by 2 inch) at the site. On Friday afternoon the swelling gone down on arm and was about 3x2 inches. It was unknown redness was caused by an allergy, but might be from the fluid in the injection. If were the actual medication, the patient thought would have hives or a rash all over my body. The patient experienced allergic reactions to KEFLEX and VICODIN and afraid of adverse reactions. The patient went to the emergency room for the KEFLEX reaction. The patient would be receive 2nd dose in 4 months.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received SHINGRIX. On 11th April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, several hours after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling, fever, muscle pain, general body pain and headache. The patient was treated with KEFLEX and VICODIN. In April 2018, the outcome of the fever, muscle pain, general body pain and headache were recovered/resolved. On an unknown date, the outcome of the injection site pain, injection site erythema and injection site swelling were unknown. It was unknown if the reporter considered the injection site pain, injection site erythema, injection site swelling, fever, muscle pain, general body pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX vaccine on Wednesday at 4 to 11 about noon. On Wednesday, at 7:00 pm, the patient experienced muscle; all over body aches, very bad headache, fever and pain, swelling and redness (about 4 into 2, 1 by 2 inch) at the site. On Friday afternoon the swelling gone down on arm and was about 3x2 inches. It was unknown redness was caused by an allergy, but might be from the fluid in the injection. If were the actual medication, the patient thought would have hives or a rash all over my body. The patient experienced allergic reactions to KEFLEX and VICODIN and afraid of adverse reactions. The patient went to the emergency room for the KEFLEX reaction. The patient would be receive 2nd dose in 4 months.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Feeding disorder, Headache, Malaise
Clinical narrative: Recommended by my private physician to get the SHINGRIX vaccine through pharmacy. Went to pharmacy and they administered first dose on 4/2/2018. On 4/3/18, I was terribly sick with diarrhea, nausea, body chills, fever, headache, arm swollen from vaccine and in pain, couldn't eat or drink for 12 hours. On 4/4/18, all symptoms are gone except for pain to vaccinated arm and swelling is coming down slowly, but remains itchy and irritated with less pain.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Recommended by my private physician to get the SHINGRIX vaccine through pharmacy. Went to pharmacy and they administered first dose on 4/2/2018. On 4/3/18, I was terribly sick with diarrhea, nausea, body chills, fever, headache, arm swollen from vaccine and in pain, couldn't eat or drink for 12 hours. On 4/4/18, all symptoms are gone except for pain to vaccinated arm and swelling is coming down slowly, but remains itchy and irritated with less pain.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin irritation
Clinical narrative: Recommended by my private physician to get the SHINGRIX vaccine through pharmacy. Went to pharmacy and they administered first dose on 4/2/2018. On 4/3/18, I was terribly sick with diarrhea, nausea, body chills, fever, headache, arm swollen from vaccine and in pain, couldn't eat or drink for 12 hours. On 4/4/18, all symptoms are gone except for pain to vaccinated arm and swelling is coming down slowly, but remains itchy and irritated with less pain.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of herpes zoster in a 52-year-old adult female patient who received SHINGRIX (batch number 3Z4KL, expiry date 30th January 2020). Co-suspect products included BENLYSTA unknown for product used for unknown indication. On 5th February 2018, the patient received SHINGRIX. In February 2018, the patient started BENLYSTA at an unknown dose and frequency. On an unknown date, less than a month after receiving SHINGRIX and 14 days after starting BENLYSTA, the patient experienced herpes zoster and rash. The action taken with BENLYSTA was unknown (Dechallenge was unknown). Rechallenge with BENLYSTA was unknown. On an unknown date, the outcome of the herpes zoster and rash were recovered/resolved. It was unknown if the reporter considered the herpes zoster and rash to be related to SHINGRIX and BENLYSTA. Additional details were reported as follows: The age at vaccination was not reported. Roughly 2 weeks after receiving SHINGRIX, the patient received BENLYSTA. The patient then experienced a mild case of herpes zoster that began during the 2 weeks after receiving BENLYSTA. The rash was resolved and the healthcare provider was unsure if there was any correlation. The healthcare professional was not sure about the exact date of BENLYSTA or Herpes zoster episode, but did occur within 1 month after the 1st dose of SHINGRIX. The patient stated that, the shingles rash was very mild and resolved with no complications. The reported lot number (L24KL) for SHINGRIX did not exist and was updated to 3Z4KL, according to sales database.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Fatigue, Impaired work ability, Neck pain, Pain in extremity
Clinical narrative: The patients symptoms began to improve within 24-30 hours, and were resolved at the time of reporting. This case was reported by a other health professional via call center representative and described the occurrence of chest pain in a 62-year-old male patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 12 hrs after receiving SHINGRIX, the patient experienced chest pain, pain in arm, neck pain, fatigue and fever. The patient was treated with TYLENOL. In April 2018, the outcome of the pain in arm, neck pain, fatigue and fever were recovered/resolved. On an unknown date, the outcome of the chest pain was recovered/resolved. It was unknown if the reporter considered the chest pain, pain in arm, neck pain, fatigue and fever to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The reporter was unsure if the patient received the vaccine on 12th April 2018 or 13th April 2018. The patient received SHINGRIX in an unknown deltoid. The patient experienced pain in the chest, arm and upper neck. The healthcare professional described the symptoms as 'felt like he got into a kicking contest with a rather large mule.' The patient had to miss one day of work, but healthcare professional was unsure if the symptoms were considered disabling. No physician visit or hospitalization was required. As treatment, the patient used TYLENOL which did not help. The patients symptoms began to improve within 24 to 30 hours, and were resolved at the time of reporting.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: The patients symptoms began to improve within 24-30 hours, and were resolved at the time of reporting. This case was reported by a other health professional via call center representative and described the occurrence of chest pain in a 62-year-old male patient who received SHINGRIX. In April 2018, the patient received the 1st dose of SHINGRIX. In April 2018, 12 hrs after receiving SHINGRIX, the patient experienced chest pain, pain in arm, neck pain, fatigue and fever. The patient was treated with TYLENOL. In April 2018, the outcome of the pain in arm, neck pain, fatigue and fever were recovered/resolved. On an unknown date, the outcome of the chest pain was recovered/resolved. It was unknown if the reporter considered the chest pain, pain in arm, neck pain, fatigue and fever to be related to SHINGRIX. Additional information was received as follows: The age at vaccination was not reported. The reporter was unsure if the patient received the vaccine on 12th April 2018 or 13th April 2018. The patient received SHINGRIX in an unknown deltoid. The patient experienced pain in the chest, arm and upper neck. The healthcare professional described the symptoms as 'felt like he got into a kicking contest with a rather large mule.' The patient had to miss one day of work, but healthcare professional was unsure if the symptoms were considered disabling. No physician visit or hospitalization was required. As treatment, the patient used TYLENOL which did not help. The patients symptoms began to improve within 24 to 30 hours, and were resolved at the time of reporting.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Injection site erythema, Rash
Clinical narrative: Diarrhea, Rash, 8cm x 10cm area of redness at injection site. Treatment Ice 2x daily, BENADRYL 25mg 3xdaily; TYLENOL 500mg 3x daily, ibuprofen 200 3x daily.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Dysphagia, Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Respiratory syncytial virus test negative
Clinical narrative: Reported 7.5 hours after receiving MMR, "broke out in hives, tongue swelled and became bumpy with blisters."  Trouble swallowing and talking.
Age: 27.0
Sex: F
Vaccine: MMR
Symptoms: Speech disorder, Streptococcus test negative, Swollen tongue, Tongue blistering, Urticaria
Clinical narrative: Reported 7.5 hours after receiving MMR, "broke out in hives, tongue swelled and became bumpy with blisters."  Trouble swallowing and talking.
Age: 5.0
Sex: F
Vaccine: DTAP, HEP, HEPA
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Mom reports swelling to Left deltoid as well as pain and itching.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: Chest X-ray abnormal, Cough, Dyspnoea, Oropharyngeal pain, Pneumonia
Clinical narrative: Received pneumonia shot 4/18/17. Diagnosed with pneumonia in May 2017. Vaccine was pneumococcal polysaccharide PPS V23 manufacturer Lot no. MO 2324, expiry 10 June 2018, VIS version date April 24, 2015. Given at hospital. About May 2, 2017, developed sore throat, cough, difficulty breathing. X-ray May 4 showed patchy right infrahilar...treated with antibiotics for pneumonia. Improved after 2 weeks.
Age: 88.0
Sex: F
Vaccine: PPV
Symptoms: X-ray
Clinical narrative: Received pneumonia shot 4/18/17. Diagnosed with pneumonia in May 2017. Vaccine was pneumococcal polysaccharide PPS V23 manufacturer Lot no. MO 2324, expiry 10 June 2018, VIS version date April 24, 2015. Given at hospital. About May 2, 2017, developed sore throat, cough, difficulty breathing. X-ray May 4 showed patchy right infrahilar...treated with antibiotics for pneumonia. Improved after 2 weeks.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site erythema in an elderly male patient who received SHINGRIX (batch number P539L, expiry date 30th January 2020). 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 erythema, headache and injection site pain. On an unknown date, the outcome of the injection site erythema, headache and injection site pain were recovering/resolving. It was unknown if the reporter considered the injection site erythema, headache and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient had experienced injection site redness that extended down to the elbow of the vaccinated arm and was painful to the tough. The patient also had a mild headache.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Hypoaesthesia, Neuropathy peripheral, Paraesthesia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of numbness in fingers in a 58-year-old female patient who received SHINGRIX. On 15th April 2018, the patient received SHINGRIX. On 15th April 2018, less than a day after receiving SHINGRIX, the patient experienced numbness in fingers, hypersensitivity, tingling of extremity and neuropathy. On an unknown date, the outcome of the numbness in fingers, hypersensitivity, tingling of extremity and neuropathy were unknown. It was unknown if the reporter considered the numbness in fingers, hypersensitivity, tingling of extremity and neuropathy to be related to SHINGRIX. Additional information was received as follows: The physician reported that the patient received a SHINGRIX at Pharmacy on 15th April 2018 and was experiencing tingling on fingers, numbness in fingers (the 2nd to 5th fingers) and on latter side of palm (all on the same side the injection was given) and also hypersensitivity of nerves and possible neuropathy. These symptoms started on the day she received the vaccine and were still persisting. No further information was provided.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Hyperaesthesia, Hypersensitivity, Hypoaesthesia, Neuropathy peripheral, Paraesthesia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of numbness in fingers in a 58-year-old female patient who received SHINGRIX. On 15th April 2018, the patient received SHINGRIX. On 15th April 2018, less than a day after receiving SHINGRIX, the patient experienced numbness in fingers, hypersensitivity, tingling of extremity and neuropathy. On an unknown date, the outcome of the numbness in fingers, hypersensitivity, tingling of extremity and neuropathy were unknown. It was unknown if the reporter considered the numbness in fingers, hypersensitivity, tingling of extremity and neuropathy to be related to SHINGRIX. Additional information was received as follows: The physician reported that the patient received a SHINGRIX at Pharmacy on 15th April 2018 and was experiencing tingling on fingers, numbness in fingers (the 2nd to 5th fingers) and on latter side of palm (all on the same side the injection was given) and also hypersensitivity of nerves and possible neuropathy. These symptoms started on the day she received the vaccine and were still persisting. No further information was provided.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Facial pain, Fatigue, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 80-year-old male patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020. Concomitant products included Pravastatin, Vitamin D3, metoprolol and Triptorelin. On 10th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5ml. On 11th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, fatigue, muscle pain, injection site erythema, injection site swelling, facial pain, neck pain and shoulder pain. In April 2018, the patient experienced facial swelling. On an unknown date, the outcome of the injection site pain, fatigue, muscle pain, injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the facial swelling, facial pain, neck pain and shoulder pain were unknown. It was unknown if the reporter considered the injection site pain, fatigue, muscle pain, injection site erythema, injection site swelling, facial swelling, facial pain, neck pain and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a registered nurse. The patient received SHINGRIX vaccine on an unknown deltoid. The nurse reported that the patient experienced pain, redness, swelling, and burning at his injection site, and experienced swelling on his face, muscle aches, and fatigue. Also, the nurse reported that the patient experienced the pain at his injection site radiating to his shoulder, neck, and face. The nurse also reported that she had other patients of unknown number that reported discomfort after the injection. This case was linked with US2018GSK071969, reported by the same reporter.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Myalgia, Neck pain, Swelling face
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 80-year-old male patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020. Concomitant products included Pravastatin, Vitamin D3, metoprolol and Triptorelin. On 10th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5ml. On 11th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, fatigue, muscle pain, injection site erythema, injection site swelling, facial pain, neck pain and shoulder pain. In April 2018, the patient experienced facial swelling. On an unknown date, the outcome of the injection site pain, fatigue, muscle pain, injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the facial swelling, facial pain, neck pain and shoulder pain were unknown. It was unknown if the reporter considered the injection site pain, fatigue, muscle pain, injection site erythema, injection site swelling, facial swelling, facial pain, neck pain and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a registered nurse. The patient received SHINGRIX vaccine on an unknown deltoid. The nurse reported that the patient experienced pain, redness, swelling, and burning at his injection site, and experienced swelling on his face, muscle aches, and fatigue. Also, the nurse reported that the patient experienced the pain at his injection site radiating to his shoulder, neck, and face. The nurse also reported that she had other patients of unknown number that reported discomfort after the injection. This case was linked with US2018GSK071969, reported by the same reporter.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 80-year-old male patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020. Concomitant products included Pravastatin, Vitamin D3, metoprolol and Triptorelin. On 10th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5ml. On 11th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, fatigue, muscle pain, injection site erythema, injection site swelling, facial pain, neck pain and shoulder pain. In April 2018, the patient experienced facial swelling. On an unknown date, the outcome of the injection site pain, fatigue, muscle pain, injection site erythema and injection site swelling were not recovered/not resolved and the outcome of the facial swelling, facial pain, neck pain and shoulder pain were unknown. It was unknown if the reporter considered the injection site pain, fatigue, muscle pain, injection site erythema, injection site swelling, facial swelling, facial pain, neck pain and shoulder pain to be related to SHINGRIX. Additional details were provided as follows: This case was reported by a registered nurse. The patient received SHINGRIX vaccine on an unknown deltoid. The nurse reported that the patient experienced pain, redness, swelling, and burning at his injection site, and experienced swelling on his face, muscle aches, and fatigue. Also, the nurse reported that the patient experienced the pain at his injection site radiating to his shoulder, neck, and face. The nurse also reported that she had other patients of unknown number that reported discomfort after the injection. This case was linked with US2018GSK071969, reported by the same reporter.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site reaction, Rash erythematous
Clinical narrative: I was given the "new" (2nd) shingles vaccine; an injection in the right arm, in the doctor's office. The injection was painful and my arm was immediately sore. The arm stayed sore for the next three days. On the second day, a red rash appeared down my arm in the vicinity of the injection. The rash remained for four days.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Diarrhoea
Clinical narrative: I received the pneumonia PCV13 vaccine around 3 pm and by that night I had severe diarrhea.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Facial paralysis, Fatigue, Injected limb mobility decreased, Injection site pain, Injection site swelling
Clinical narrative: Swollen Lymph nodes under left arm. Left upper arm swollen, intense pain in left arm with limited range of motion in left arm morning after flu shot. One week later Bell's Palsy to right side of face, muscle weakness in legs, extremely fatigue, electric shocks in both arms and legs. Intense pain in left arm from injection site to elbow to wrist continues 6 months later as well as extremely fatigue and weak.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Lymphadenopathy, Muscle enzyme increased, Muscular weakness, Pain in extremity, Paraesthesia
Clinical narrative: Swollen Lymph nodes under left arm. Left upper arm swollen, intense pain in left arm with limited range of motion in left arm morning after flu shot. One week later Bell's Palsy to right side of face, muscle weakness in legs, extremely fatigue, electric shocks in both arms and legs. Intense pain in left arm from injection site to elbow to wrist continues 6 months later as well as extremely fatigue and weak.
Age: 84.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Feeling abnormal, Pain in extremity
Clinical narrative: Patient received two vaccinations. SHINGRIX Lot # HG4P3 in left arm and PNEUMOVAX 23 in Right Arm. A few hours after receiving vaccine, patient's right arm began to ache/hurt severely and she began to feel weak. Husband called pharmacy to report she was on the couch feeling terrible.  Advised him to give her Acetaminophen and would call back to check on her later. Called patient's home the next day and husband reported that she felt so bad later in the evening that he took her to the ER. He felt she was also reacting to the Acetaminophen as she rarely takes any medication. She was examined at the ER and sent home. By the time of follow-up she was improving and able to use the arm a little. Spouse noted at that time that the affected arm was the side she had her mastectomy on. She was by then experiencing a lesser degree of soreness also in the left arm. Followed up with spouse a few days late and patient was doing well.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Dysarthria, Flushing, Paraesthesia, Pyrexia, Skin discolouration
Clinical narrative: High fevers, feeling of needles in nerves, slurred speech, flushed/discoloration.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Blood immunoglobulin G, Blood immunoglobulin M, Rash, Varicella, Varicella virus test
Clinical narrative: Moderate varicella rash.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Lymph node pain
Clinical narrative: On the morning after, I woke up to pain, swelling and redness at the site of the injection. This am, 3 full days later it is still red and hot to the touch. I also woke up at 3:30 am with my lymph gland under my left arm swollen and sore. I am trying to get an appointment with my family physical but he is booked for several days.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Lymphadenopathy
Clinical narrative: On the morning after, I woke up to pain, swelling and redness at the site of the injection. This am, 3 full days later it is still red and hot to the touch. I also woke up at 3:30 am with my lymph gland under my left arm swollen and sore. I am trying to get an appointment with my family physical but he is booked for several days.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Heart rate increased, Laboratory test, Pruritus, Urticaria, Vaccination complication
Clinical narrative: Patient's wife called and said husband had bad reaction to shot. Said he was itching, covered in welts and vomiting. Said his heart rate was elevated. She took him to their family doctor but she was on vacation and Dr was filling in. Said they gave her husband prednisone for reaction. His heart rate was still elevated so they referred him to hospital for more tests. She said he was feeling better and they were waiting for test results.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient's wife called and said husband had bad reaction to shot. Said he was itching, covered in welts and vomiting. Said his heart rate was elevated. She took him to their family doctor but she was on vacation and Dr was filling in. Said they gave her husband prednisone for reaction. His heart rate was still elevated so they referred him to hospital for more tests. She said he was feeling better and they were waiting for test results.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Injection site erythema, Injection site pain, Injection site pruritus
Clinical narrative: REDNESS, ITCHING, SWELLING, PAIN AT INJECTION SITE, HEADACHE, MUSCLE PAIN, TIREDNESS, AND FEVER OF 102.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site swelling, Myalgia, Pyrexia
Clinical narrative: REDNESS, ITCHING, SWELLING, PAIN AT INJECTION SITE, HEADACHE, MUSCLE PAIN, TIREDNESS, AND FEVER OF 102.
Sex: M
Vaccine: HPV4
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: My son developed a serious rash on his body after receiving the first shot of GARDASIL, red, raised bumps, ranging in size.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician and refers to a patient of unknown age. No information regarding the patient's medical history, concurrent conditions or concomitant medications was provided. On 17-APR-2018, the patient was vaccinated with an expired dose of RECOMBIVAX HB injection, intramuscularly, lot # L040458 with expiration date on 04-FEB-2018. No adverse effects were reported.
Sex: U
Vaccine: HEP, HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a medical assistant refers to a adult patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 23-APR-2018, the patient was vaccinated with pediatric dose of both vaccines VAQTA (dose, units and frequency not reported) (lot number N019924 and expiration date: 02-SEP-2019) intramuscularly and RECOMBIVAX HB (dose, units and frequency not reported) (lot number M037248 and expiration date: 21-FEB-2019) intramuscularly (drug administered to patient of inappropriate age). No adverse effects have been reported to the patient. No product quality complaint was involved.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site swelling
Clinical narrative: Initial unsolicited report received from Nurse on 30-Mar-2018. This case involves 4-year-old male patient who was vaccinated with 0.5 ml single dose of QUADRACEL (Batch number: C5248AA, expiration date-21-Aug-2019, site- unknown, dose in series not reported) intramuscularly on 27-Mar-2018. The patient's medical history and concomitant medications were not reported. On 28-Mar-2018, one day following the vaccination, the patient had 6 X 8 raised area on the left thigh. Lab data was not reported. Corrective treatment was not reported. Outcome of the event was unknown. List of documents held by sender: none.
Age: 1.17
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Mucous stools
Clinical narrative: Mucousy stools since vaccines.
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Diarrhoea, Fatigue, Injection site erythema
Clinical narrative: I obtained my first injection of the SHINGRIX vaccine on 4/13/18. Second injection to be 2-6 months later. Not sure if I should obtain second injection??? Experienced the following day 4/14/18 - redness, swelling and extreme soreness in my left arm where the injection was administered. Other side effects - muscle pain, feeling very fatigued, tired and weak. Upset stomach and diarrhea. These symptoms lasted 2-4 days following the date on first injection. Difficulty sleeping 4/13/18.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Insomnia, Myalgia
Clinical narrative: I obtained my first injection of the SHINGRIX vaccine on 4/13/18. Second injection to be 2-6 months later. Not sure if I should obtain second injection??? Experienced the following day 4/14/18 - redness, swelling and extreme soreness in my left arm where the injection was administered. Other side effects - muscle pain, feeling very fatigued, tired and weak. Upset stomach and diarrhea. These symptoms lasted 2-4 days following the date on first injection. Difficulty sleeping 4/13/18.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Diarrhoea, Hot flush, Loss of consciousness, Myalgia, Nausea
Clinical narrative: Nausea with hot flashes and severe muscle aches. Vomiting, diarrhea and passed out on the bathroom floor.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Vomiting
Clinical narrative: Nausea with hot flashes and severe muscle aches. Vomiting, diarrhea and passed out on the bathroom floor.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Cough, Feeling abnormal, Influenza like illness, Myalgia
Clinical narrative: Pt called office to describe symptoms that mimicked the flu. Nausea, aching muscles, tightness in chest, and in esophagus, also coughing. Pt stated "felt terrible".
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Oesophageal discomfort
Clinical narrative: Pt called office to describe symptoms that mimicked the flu. Nausea, aching muscles, tightness in chest, and in esophagus, also coughing. Pt stated "felt terrible".
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Patient had swelling, redness, and pain in the arm that the vaccine was injected.
Age: 33.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Vaccine was given intramuscularly on Left arm. Patient had no adverse outcome.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Back pain, Chills, Erythema, Influenza virus test negative, Nausea
Clinical narrative: 6.5 cm x 10 cm Right arm erythema, Fever 100.5, chills, nausea, neck and back pain. Apply cold compresses twice a day. Continue Ibuprofen.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Neck pain, Pyrexia, Streptococcus test negative
Clinical narrative: 6.5 cm x 10 cm Right arm erythema, Fever 100.5, chills, nausea, neck and back pain. Apply cold compresses twice a day. Continue Ibuprofen.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Body temperature increased, Gait disturbance, Vaccination site erythema, Vaccination site pain, Vaccination site warmth
Clinical narrative: Developed erythema, warmth and tenderness around vaccine site 2 days later that progressively increased in size over the next 24 hours. Causes some mild limping. No fevers at this time (did have temp to 102 the day after the vaccine).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased appetite, Fatigue, Headache, Malaise
Clinical narrative: The night after the vaccination I was fatigued, tired with headache, shivers and did not feel well. I felt the same way the next day but went to workout at the gym anyway. All day and that night, 4/25/18, I was not hungry, headache and felt achy and sick all over. This was from the vaccine nothing else. I am generally a very healthy person, eat right and exercise everyday. So I thought I should report it.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: The night after the vaccination I was fatigued, tired with headache, shivers and did not feel well. I felt the same way the next day but went to workout at the gym anyway. All day and that night, 4/25/18, I was not hungry, headache and felt achy and sick all over. This was from the vaccine nothing else. I am generally a very healthy person, eat right and exercise everyday. So I thought I should report it.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pruritus, Injection site vesicles
Clinical narrative: On 4/26/18 at 1400 this client appeared at clinic with concerns following a vaccine she received at this location, on 4/23/18 at 0940. She said that she discovered a blistered area at site of injection on 4/24/18 at approximately 1400. Observed the area on the left deltoid to have an intact clear fluid filled blister present. It was measured to be 10 mm long by 5mm wide. There was no erythema and no swelling noted. Client denied any pain but said that the area was scratchy. Client was instructed to NOT puncture/pop the blister, to allow the area to heal without intervention. She was instructed on s/s of infection and to seek medical attention if she felt it be necessary. She verbalized understanding of information presented.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Urticaria
Clinical narrative: Patient received vaccine at doctor's office earlier today. Patient broke out in hives. Patient called the pharmacy for advice. Pharmacy advised patient to take diphenhydramine and to call physician if no improvement occurs.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ, TDAP
Symptoms: Confusional state, Disorientation, Eye movement disorder
Clinical narrative: About one hour after the vaccinations, patient had returned to school and had an episode where she became disoriented. Her friend said her eyes went off to the side, and this lasted about 2 minutes. Patient was then a little bit confused afterwards.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Myalgia, Nausea
Clinical narrative: Within 24 hrs, pt began having chills, myalgias, nausea, extreme fatigue. Pt seen by PCP at 48hrs after injection with symptoms remaining.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Dizziness, Fatigue, Headache
Clinical narrative: On April 24, 2018, the date of the vaccination, I initially did not have a reaction. That evening I developed a headache and the area of the injection was painful and eventually I felt rather fatigued. I took 1 ibuprofen. On April 25th, I went to exercise class. After 20 minutes, I became faint--stopped exercise --found I was very fatigued. I left the class. I managed to drive home. For the rest of the day I was in bed, dozing off intermittently and feeling generally very fatigued and unsteady. I felt achy, my arm turned red at the site of the injection and was painful. If there was swelling, it was minimal. I took a generic 500 mg TYLENOL one at a time--three times that day.  April 26th, today, I felt faint upon first getting up in the morning. I felt better after breakfast and took 2 generic TYLENOL. I went to an appointment. At this point, there is only faint pain at the inoculation site. I am able to do some activities and then rest a few minutes. Getting better and have more energy.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Pain
Clinical narrative: On April 24, 2018, the date of the vaccination, I initially did not have a reaction. That evening I developed a headache and the area of the injection was painful and eventually I felt rather fatigued. I took 1 ibuprofen. On April 25th, I went to exercise class. After 20 minutes, I became faint--stopped exercise --found I was very fatigued. I left the class. I managed to drive home. For the rest of the day I was in bed, dozing off intermittently and feeling generally very fatigued and unsteady. I felt achy, my arm turned red at the site of the injection and was painful. If there was swelling, it was minimal. I took a generic 500 mg TYLENOL one at a time--three times that day.  April 26th, today, I felt faint upon first getting up in the morning. I felt better after breakfast and took 2 generic TYLENOL. I went to an appointment. At this point, there is only faint pain at the inoculation site. I am able to do some activities and then rest a few minutes. Getting better and have more energy.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Swelling and redness in right arm, hot to touch, very painful according to pt.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Pyrexia
Clinical narrative: The patient called today and stated he felt under the weather and had a fever of 99.5.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Breast discomfort, Breast pain, Herpes zoster, Rash
Clinical narrative: 4/13/2018: Right breast pain & feeling of heaviness. Had to hold up right breast. 4/14/2018: Rash outbreak on right side of breast & under arm pit. 4/15/2018: I called hospital advice line & spoke to a nurse at 10 pm, Painful breast & rash area. 4/16/2018: Got phone consult with Dr., I sent photos of rash via email, 4/18/2018: Got Rx for NORCO & Naprosyn for pain cuz OTC analgesics not helping. Sent more photos as rash increasing. Dr. said it definitely looked like shingles  4/20/2018: Reported to GlaxoSmithKline spoke to RPh that I got shingles from the SHINGRIX vaccine. I had called GSK on 4/16/2018 to report effects.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Breast discomfort, Breast tenderness, Herpes zoster, Injection site injury, Injection site pain
Clinical narrative: 4/13/2018: Right breast pain & feeling of heaviness. Had to hold up right breast. 4/14/2018: Rash outbreak on right side of breast & under arm pit. 4/15/2018: I called hospital advice line & spoke to a nurse at 10 pm, Painful breast & rash area. 4/16/2018: Got phone consult with Dr., I sent photos of rash via email, 4/18/2018: Got Rx for NORCO & Naprosyn for pain cuz OTC analgesics not helping. Sent more photos as rash increasing. Dr. said it definitely looked like shingles  4/20/2018: Reported to GlaxoSmithKline spoke to RPh that I got shingles from the SHINGRIX vaccine. I had called GSK on 4/16/2018 to report effects.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Insomnia, Pain, Pain of skin, Rash, Skin burning sensation
Clinical narrative: 4/13/2018: Right breast pain & feeling of heaviness. Had to hold up right breast. 4/14/2018: Rash outbreak on right side of breast & under arm pit. 4/15/2018: I called hospital advice line & spoke to a nurse at 10 pm, Painful breast & rash area. 4/16/2018: Got phone consult with Dr., I sent photos of rash via email, 4/18/2018: Got Rx for NORCO & Naprosyn for pain cuz OTC analgesics not helping. Sent more photos as rash increasing. Dr. said it definitely looked like shingles  4/20/2018: Reported to GlaxoSmithKline spoke to RPh that I got shingles from the SHINGRIX vaccine. I had called GSK on 4/16/2018 to report effects.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin discomfort
Clinical narrative: 4/13/2018: Right breast pain & feeling of heaviness. Had to hold up right breast. 4/14/2018: Rash outbreak on right side of breast & under arm pit. 4/15/2018: I called hospital advice line & spoke to a nurse at 10 pm, Painful breast & rash area. 4/16/2018: Got phone consult with Dr., I sent photos of rash via email, 4/18/2018: Got Rx for NORCO & Naprosyn for pain cuz OTC analgesics not helping. Sent more photos as rash increasing. Dr. said it definitely looked like shingles  4/20/2018: Reported to GlaxoSmithKline spoke to RPh that I got shingles from the SHINGRIX vaccine. I had called GSK on 4/16/2018 to report effects.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nausea, Pain, Pyrexia, Vaccination complication
Clinical narrative: 2 hours after injection received headache and body ache. Next day had fever of 99.9 and nausea.  Went to MD and the MD said must be a reaction to the vaccine.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Client began to have significant swelling of the right arm the day after receiving the BEXSERO vaccine. Reactions were redness, swelling, itching, and it had fever in it (hot to the touch). The s/s lasted for 4-5 days. No treatment was used.
Age: 16.0
Sex: F
Vaccine: MEN, MENB, TDAP
Symptoms: Blood test normal, Chills, Crying, Fear, Feeling hot
Clinical narrative: She had chills starting when she woke up the day after the shot. By about 7pm, she had spiked a fever of 102.5. She was burning hot all over and continued with chills. She was crying and scared. She said her body ached. Her arms hurt where the injection sites were but there was no bump or rash that i could see. We gave her TYLENOL at 9 and her fever of 102.5 continued until about midnight. (She rarely ever gets a high fever like this). She was up throughout the night. By morning her fever was ranged from 100-101 and stayed that way until about 3pm when it dropped to 99.5. Then it continued to drop and she was fine by 9 pm. She was seen by her dr. this afternoon and missed school (two days after the shot) where they tested her blood and did a flu shot. She was negative. She had no other symptoms.
Age: 16.0
Sex: F
Vaccine: MEN, MENB, TDAP
Symptoms: Influenza virus test negative, Injection site pain, Loss of personal independence in daily activities, Pain, Pyrexia
Clinical narrative: She had chills starting when she woke up the day after the shot. By about 7pm, she had spiked a fever of 102.5. She was burning hot all over and continued with chills. She was crying and scared. She said her body ached. Her arms hurt where the injection sites were but there was no bump or rash that i could see. We gave her TYLENOL at 9 and her fever of 102.5 continued until about midnight. (She rarely ever gets a high fever like this). She was up throughout the night. By morning her fever was ranged from 100-101 and stayed that way until about 3pm when it dropped to 99.5. Then it continued to drop and she was fine by 9 pm. She was seen by her dr. this afternoon and missed school (two days after the shot) where they tested her blood and did a flu shot. She was negative. She had no other symptoms.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea
Clinical narrative: Diarrhea lasting at least 2 days.
Age: 61.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Dehydration, Diarrhoea, Influenza like illness, Vomiting
Clinical narrative: Horrible flu like symptoms, chills, vomiting, diarrhea, dehydration.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: 2 hrs after injection pt experienced sharp stabbing pain at injection site, partially relieved by TYLENOL. Woke up 4/25/18 with redness around injection sie extending down arm just above elbow.
Age: 16.0
Sex: M
Vaccine: HEP, IPV, MENB, HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a male patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 23-APR-2018, the patient was vaccinated with expired dose of RECOMBIVAX HB (dose, units and frequency not reported) (lot # M000442 and expiration date: 31-MAR-2018) intramuscularly (expired product administered). No adverse effects were reported. Reporter confirmed that, there was no temperature excursion prior to being administered. No product quality complaint was involved.
Age: 16.0
Sex: M
Vaccine: HEP, IPV, MENB, HEP
Symptoms: Expired product administered
Clinical narrative: This spontaneous report was received from a medical assistant refers to a male patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 23-APR-2018, the patient was vaccinated with expired dose of RECOMBIVAX HB (dose, units and frequency not reported) (lot # M000442 and expiration date: 31-MAR-2018) intramuscularly (expired product administered). No adverse effects were reported. Reporter confirmed that, there was no temperature excursion prior to being administered. No product quality complaint was involved.