chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HIBV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 01-JUN-2018, the patient was vaccinated with an improperly stored dose of LIQUID PEDVAXHIB, lot # N022167, expiration date: 08-FEB-2020 (dose and route of administration were not reported). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 47 to 77 degrees Fahrenheit for 5 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1806USA001505: US-009507513-1806USA009026: US-009507513-1806USA009027: US-009507513-1806USA009028: US-009507513-1806USA009029: US-009507513-1806USA009030: US-009507513-1806USA009031: US-009507513-1806USA009032: US-009507513-1806USA009033: US-009507513-1806USA009034: US-009507513-1806USA009035: US-009507513-1806USA009036: US-009507513-1806USA009037: US-009507513-1806USA009038: US-009507513-1806USA009039: US-009507513-1806USA009040: US-009507513-1806USA009041: US-009507513-1806USA009042: US-009507513-1806USA009043: US-009507513-1806USA009044: US-009507513-1806USA009045: US-009507513-1806USA009046: US-009507513-1806USA009047: US-009507513-1806USA009048: US-009507513-1806USA009049: US-009507513-1806USA009050: US-009507513-1806USA009051: US-009507513-1806USA009052: US-009507513-1806USA009053: US-009507513 1806USA009054: US-009507513-1806USA009056.
Sex: U
Vaccine: MMRV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 28-year-old patient of unknown gender. The patient concurrent condition, medical history and concomitant medications were not reported. On 17-JUN-2018, the patient was vaccinated with PROQUAD, subcutaneous for prophylaxis (Drug administered to patient of inappropriate age). No known adverse effects. No PQC (product quality compliant) was reported.
Sex: U
Vaccine: VARZOS
Symptoms: 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 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional information was reported as follows: The healthcare professional reported, that almost all of her patients she vaccinated with SHINGRIX complained about soreness in the arm where the vaccine was given and the symptoms lasted for up to 1 week. No further information was provided about each specific patient since it was too many to capture. This case was linked to case US2018106485, reported by the same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: 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 unspecified number of an adult patients 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 erythema and injection site pain. SHINGRIX was discontinued. On an unknown date, the outcome of the injection site erythema and injection site pain were unknown. It was unknown if the reporter considered the injection site erythema and injection site pain to be related to SHINGRIX. Additional details were provided as follows: The age group was not reported but was selected as adult as per vaccine indication. The healthcare professional stated that all of my patients were complained about the side effects of SHINGRIX such as the redness and pain at injection site and did not want to get the 2nd dose. The healthcare professional did not provide any further details about all of her patients' complaints. This case has been linked with case US2018107240, reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult 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 adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter indicated that the receptionist at her dermatology office experienced bad reactions (unspecified) after receiving the SHINGRIX vaccine. The reporter wanted to end the call, so was unable to obtain additional information. This case was one of the 5 cases reported by the same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a adult 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 pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the patient's friend. The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The patient experienced sore arm. The reporter wanted to end the call, so was unable to obtain additional information. This case was one of the 5 cases reported by the same reporter.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ
Symptoms: Headache, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of fever in a 16-year-old male patient who received BEXSERO (batch number 166901A, expiry date 30th November 2018) for prophylaxis. Co-suspect products included MENVEO (batch number M17038, expiry date 31st March 2019) for prophylaxis. On 13th June 2018, the patient received BEXSERO (intramuscular) .5 ml and MENVEO (intramuscular) .5 ml. In June 2018, less than a week after receiving BEXSERO and MENVEO, the patient experienced fever, pain in arm, nausea, pain and headache. On an unknown date, the outcome of the fever, pain in arm, nausea, pain and headache were not recovered/not resolved. The reporter considered the fever, pain in arm, nausea, pain and headache to be related to BEXSERO and MENVEO. Additional details were provided as follows: The patient received MENVEO and BEXSERO in the reporting physician's office a day before the reporting date. The patient complained about achiness, headache, nausea, mild fever and soreness on his arm. This case has been linked to case US2018107284, reported by the same reporter.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Injection site discomfort, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site discomfort in a 72-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 12th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th June 2018, immediately after receiving SHINGRIX, the patient experienced injection site discomfort. On 15th June 2018, the patient experienced injection site warmth, injection site swelling, injection site itching and injection site erythema. The patient was treated with TYLENOL and BENADRYL. On an unknown date, the outcome of the injection site discomfort and injection site erythema were recovering/resolving and the outcome of the injection site warmth was not recovered/not resolved and the outcome of the injection site swelling and injection site itching were recovered/resolved. The reporter considered the injection site discomfort, injection site warmth, injection site swelling, injection site itching and injection site erythema to be probably related to SHINGRIX. Additional details were provided as follows: The health care professional reported at 13:15, the patient experienced discomfort when receiving the SHINGRIX injection on left deltoid. The patient experienced itching, redness, swelling, and warmth around the injection site beginning 3 days after receiving the SHINGRIX. The swelling around the injection site had gotten worse from June 15th to 17th June 2018. The health care professional recommended ice and TYLENOL. The health care professional had called the patient back and the patient notified him that her symptoms had improved greatly after taking only BENADRYL. The itching had resolved and there was almost no more redness.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site discomfort in a 72-year-old female patient who received SHINGRIX (batch number TP5E5, expiry date 15th November 2020) for prophylaxis. On 12th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 12th June 2018, immediately after receiving SHINGRIX, the patient experienced injection site discomfort. On 15th June 2018, the patient experienced injection site warmth, injection site swelling, injection site itching and injection site erythema. The patient was treated with TYLENOL and BENADRYL. On an unknown date, the outcome of the injection site discomfort and injection site erythema were recovering/resolving and the outcome of the injection site warmth was not recovered/not resolved and the outcome of the injection site swelling and injection site itching were recovered/resolved. The reporter considered the injection site discomfort, injection site warmth, injection site swelling, injection site itching and injection site erythema to be probably related to SHINGRIX. Additional details were provided as follows: The health care professional reported at 13:15, the patient experienced discomfort when receiving the SHINGRIX injection on left deltoid. The patient experienced itching, redness, swelling, and warmth around the injection site beginning 3 days after receiving the SHINGRIX. The swelling around the injection site had gotten worse from June 15th to 17th June 2018. The health care professional recommended ice and TYLENOL. The health care professional had called the patient back and the patient notified him that her symptoms had improved greatly after taking only BENADRYL. The itching had resolved and there was almost no more redness.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site reaction, Myalgia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site reaction in a female patient who received SHINGRIX for prophylaxis. In April 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site reaction and myalgia. On an unknown date, the outcome of the injection site reaction and myalgia were unknown. It was unknown if the reporter considered the injection site reaction and myalgia to be related to SHINGRIX. Additional details were provided as follows: This case was reported by the healthcare professional (HCP) for himself. The age at vaccination was not reported. The patient reported that she experienced a severe injection site reaction and extreme myalgia. The patient did not want to provide any information regarding the adverse events. The patient would not provide an address or any other information.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash, Swelling
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of localized erythema in a 51-year-old female patient who received SHINGRIX (batch number ML532, expiry date 13th July 2020) for prophylaxis. On 17th June 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. In June 2018, less than a week after receiving SHINGRIX, the patient experienced localized erythema and local swelling. On an unknown date, the outcome of the localized erythema and local swelling were unknown. The reporter considered the localized erythema and local swelling to be probably related to SHINGRIX. Additional details were provided as follows: After receiving SHINGRIX in left deltoid, the patient experienced red, swollen, bumps approximately two inches from where the needle punctured the skin. The reporter was unable to provide additional information.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Heart rate increased, Muscle twitching, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 5 min after receiving SHINGRIX, the patient experienced heart rate increased, tremor of hands, muscle twitching, pain localized, energy decreased and joint pain. On an unknown date, the outcome of the heart rate increased, tremor of hands, muscle twitching, pain localized, energy decreased and joint pain were unknown. It was unknown if the reporter considered the heart rate increased, tremor of hands, muscle twitching, pain localized, energy decreased and joint pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's heart rate jumped to 125 about 5 minutes after the injection and hands shook. The patient experienced calves quivered which continued for 3 to 5 days and also experienced local pain lasted for 3 days, low energy and joint pain for a week. This was 1 of 2 cases, reported by same reporter for same patient. Lab Comments: Lab test performed on an unknown date.
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of heart rate increased in a adult male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, 5 min after receiving SHINGRIX, the patient experienced heart rate increased, tremor of hands, muscle twitching, pain localized, energy decreased and joint pain. On an unknown date, the outcome of the heart rate increased, tremor of hands, muscle twitching, pain localized, energy decreased and joint pain were unknown. It was unknown if the reporter considered the heart rate increased, tremor of hands, muscle twitching, pain localized, energy decreased and joint pain to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient's heart rate jumped to 125 about 5 minutes after the injection and hands shook. The patient experienced calves quivered which continued for 3 to 5 days and also experienced local pain lasted for 3 days, low energy and joint pain for a week. This was 1 of 2 cases, reported by same reporter for same patient. Lab Comments: Lab test performed on an unknown date.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of general body pain in a 62-year-old male patient who received SHINGRIX (batch number DK74P, expiry date 6th March 2020) for prophylaxis. On 2nd March 2018, the patient received SHINGRIX (intramuscular) .5 ml. On 3rd March 2018, 1 days after receiving SHINGRIX, the patient experienced general body pain and fever. On 4th March 2018, the outcome of the general body pain and fever were recovered/resolved. It was unknown if the reporter considered the general body pain and fever to be related to SHINGRIX. Additional details were provided as follows: There was no follow and targeted follow up requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction
Clinical narrative: This case was reported by a other health professional and described the occurrence of injection site reaction in a male 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 month after receiving SHINGRIX, the patient experienced injection site reaction and shingles. On an unknown date, the outcome of the injection site reaction and shingles were unknown. It was unknown if the reporter considered the injection site reaction and shingles to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the healthcare professional who himself was the patient. The age at vaccination was not reported. After the injection the patient had a bad reaction in the injection site, and within 10 days had a bad case of shingles. Now the patient was concerned with the upcoming second dose of SHINGRIX, regarding what would happen if he skipped this dosage. He asked what were the chances of another shingles attack if he receive 2nd dose. This was a very bad occurrence as per the patient, he further asked what he should do. The patient wanted advice, as he had not decided on what to do and did not want a bunch of grief from the physician. The patient gave details of vaccination administration (VAERS).
Sex: U
Vaccine: VARZOS
Symptoms: Adverse event
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of adverse event in a adult 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 adverse event. On an unknown date, the outcome of the adverse event was unknown. It was unknown if the reporter considered the adverse event to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The age group was not reported but was selected as adult as per vaccine indication. The reporter indicated that the physician at her dermatology office experienced bad reactions (unspecified) after receiving the SHINGRIX vaccine. The reporter wanted to end the call, so was unable to obtain additional information. This case was one of the 5 cases reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of fatigue in a adult male 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 fatigue and chills. On an unknown date, the outcome of the fatigue and chills were unknown. It was unknown if the reporter considered the fatigue and chills to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported.
Age: 1.25
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of induration in a 15-month-old female patient who received INFANRIX for prophylaxis. Co-suspect products included VARICELLA VACCINE for prophylaxis. On 18th June 2018, the patient received INFANRIX and VARICELLA VACCINE. In June 2018, less than a week after receiving INFANRIX, the patient experienced induration and redness of legs. On an unknown date, the outcome of the induration and redness of legs were unknown. It was unknown if the reporter considered the induration and redness of legs to be related to INFANRIX. Additional details were provided as follows: The patient was administered INFANRIX and Varicella vaccine on right leg. On 20th June 2018, the patient came to the physician as had a 3 by 4 red hardened area on leg.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Influenza like illness, Myalgia, Night sweats
Clinical narrative: This case was reported by a consumer and described the occurrence of pain localized in a 62-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of heart rate increased (also experienced shaking of hand, calves quivered, local pain, joint pain and low energy, refer case US2018GSK108687). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced pain localized, joint pain, muscle pain, influenza-like symptoms, fever, night sweat and energy decreased. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain localized, joint pain, muscle pain, influenza-like symptoms, fever, night sweat and energy decreased were recovered/resolved. It was unknown if the reporter considered the pain localized, joint pain, muscle pain, influenza-like symptoms, fever, night sweat and energy decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced local pain for 3 days, extreme joint and muscle pain like the flu after 12 hours after vaccination and continuing for 24 hours. The patient also experienced low grade fever, night sweats and low energy for 3 days. The patient was back to normal after this period.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: This case was reported by a consumer and described the occurrence of pain localized in a 62-year-old male patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of heart rate increased (also experienced shaking of hand, calves quivered, local pain, joint pain and low energy, refer case US2018GSK108687). On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, 12 hrs after receiving SHINGRIX, the patient experienced pain localized, joint pain, muscle pain, influenza-like symptoms, fever, night sweat and energy decreased. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain localized, joint pain, muscle pain, influenza-like symptoms, fever, night sweat and energy decreased were recovered/resolved. It was unknown if the reporter considered the pain localized, joint pain, muscle pain, influenza-like symptoms, fever, night sweat and energy decreased to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced local pain for 3 days, extreme joint and muscle pain like the flu after 12 hours after vaccination and continuing for 24 hours. The patient also experienced low grade fever, night sweats and low energy for 3 days. The patient was back to normal after this period.
Sex: F
Vaccine: PNC13
Symptoms: Skin indentation, Skin ulcer
Clinical narrative: This is a spontaneous report from a contactable physician via Pfizer sales representative. A 66-year-old female patient received PREVNAR 13, on an unspecified date at single dose for immunisation.  The patient medical history and concomitant medications were not reported. On an unknown date after vaccination (a short time later) the patient experienced a large sore on her arm and had left a dent in the arm. The outcome of the event was unknown. Information on the batch number has been requested.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Diplopia
Clinical narrative: Double vision post 2 days after SHINGRIX vaccine. Patient seen in urgent care and was given Prednisone 20 mg. Patient advised to go to E.R. but went other.
Age: 62.0
Sex: M
Vaccine: TDAP
Symptoms: Dizziness, Fatigue, Headache
Clinical narrative: Headache, dizziness, fatigue.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient reports an oral temperature of 99.5 degrees F for 2 days following the vaccine with tenderness/soreness of the arm at and around the injection site. This was accompanied by small patches of red spots around the injection site for about a week.
Age: 18.0
Sex: F
Vaccine: FLUA3, IPV, MEN, MMR, TDAP
Symptoms: Cystitis interstitial, Ehlers-Danlos syndrome, Immediate post-injection reaction, Postural orthostatic tachycardia syndrome
Clinical narrative: 3 chronic illnesses: Interstitial Cystitis: showed symptoms immediately after vaccinations. Ehlers Danlos Syndrome: showed symptoms 5 months after vaccinations. Postural Orthostatic Tachycardia Syndrome: showed symptoms 5 months after vaccinations.
Age: 69.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Burning sensation, Diarrhoea, Erythema, Musculoskeletal chest pain, Pain in extremity
Clinical narrative: Pt coming in as 2-3 weeks ago she was in to get the new shingles shot. Her (R) arm turned red. She came in to be seen in office and was given pred. A week or so after that she dev red sores on her chest and base of her neck. She stayed in bed. At that time she had been off of the pred for 36 hr and dev diarrhea. She has new sores in her scalp. Pain has moved down into her arms and posterior rib cage and into her hips. States they all are tender to touch- but not like when it started and was like it was on fire. She states it is not the joints that hurt- just her skin.
Age: 69.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Pain of skin, Skin ulcer, Tenderness
Clinical narrative: Pt coming in as 2-3 weeks ago she was in to get the new shingles shot. Her (R) arm turned red. She came in to be seen in office and was given pred. A week or so after that she dev red sores on her chest and base of her neck. She stayed in bed. At that time she had been off of the pred for 36 hr and dev diarrhea. She has new sores in her scalp. Pain has moved down into her arms and posterior rib cage and into her hips. States they all are tender to touch- but not like when it started and was like it was on fire. She states it is not the joints that hurt- just her skin.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation, Full blood count normal, Neuralgia, Paraesthesia
Clinical narrative: Tingling, burning and shooting nerve impulses within all four limbs and lower legs since June 2, 2018 and symptoms are ongoing currently.
Age: 1.83
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Circumstance or information capable of leading to medication error, Device connection issue, Scratch
Clinical narrative: Child kicked left leg as RN administered Hep A, and needle became dislodged with only half of the vaccine having been administered. RN replaced needle on syringe, recleaned site of left leg and administered the rest of the vaccine without incident. Mother aware of the small surface scratch caused by needle on child's left thigh. RN cleaned and bandaged sites.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient described having an extremely sore arm. The soreness is still present as of 6/25/18.  Unknown treatment, if any.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Patient states she woke up the day after vaccine and her arm was red from her shoulder to the elbow. Lasted a few days.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Dizziness, Headache, Injection site erythema, Injection site pain
Clinical narrative: Dizzy, trembling, muscular aches, headache, upset stomach, painful area of injection site, red, deep pain, deep itching, swollen. This is day three of post injection, are still has pain, but better. Lethargic, but today better. Phar. that gave injection suggested two Tylenol when I got home. Have continued 2-4 Tylenol, daily.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Lethargy, Myalgia, Tremor
Clinical narrative: Dizzy, trembling, muscular aches, headache, upset stomach, painful area of injection site, red, deep pain, deep itching, swollen. This is day three of post injection, are still has pain, but better. Lethargic, but today better. Phar. that gave injection suggested two Tylenol when I got home. Have continued 2-4 Tylenol, daily.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: 1 inch firm tender swelling at injection site, not warm at 1 week post injection. Resolved by 2 weeks.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site - red (size of a softball), hot to the touch and swelling. The redness was present for over a month. It did "fade" over a month to pick, then very light pink.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site pain, Mental impairment, Musculoskeletal pain, Myalgia
Clinical narrative: Day of vaccination 6-8 redness, a little soreness and warm to touch, day 4 (6-12) following symptoms: red rash, pain going up across the neck and as each day followed continue until the pain was from left shoulder to neck and back down the right shoulder, continued with muscle pain, seemed to affect her thinking process. Went to MD on 6-22-2018 placed on prednisone 20mg bid x5 days, Patient came in to pharmacy on 6-22 spoke on Monday 6-25-2018 and feeling much better after the prednisone. Patient's main concern is that this reaction to the 2 series shot be reported.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain, Rash erythematous, Skin warm
Clinical narrative: Day of vaccination 6-8 redness, a little soreness and warm to touch, day 4 (6-12) following symptoms: red rash, pain going up across the neck and as each day followed continue until the pain was from left shoulder to neck and back down the right shoulder, continued with muscle pain, seemed to affect her thinking process. Went to MD on 6-22-2018 placed on prednisone 20mg bid x5 days, Patient came in to pharmacy on 6-22 spoke on Monday 6-25-2018 and feeling much better after the prednisone. Patient's main concern is that this reaction to the 2 series shot be reported.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Herpes zoster, Malaise, Pain, Pain in extremity
Clinical narrative: I broke out in full blown shingles: severe pain down one side, across my hip, and down my leg. I was sick for 5 weeks - the identifying rash appeared around June 18, 2018. The SHINGRIX innoculation was given to me at pharmacy on April 16, 2018.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash
Clinical narrative: I broke out in full blown shingles: severe pain down one side, across my hip, and down my leg. I was sick for 5 weeks - the identifying rash appeared around June 18, 2018. The SHINGRIX innoculation was given to me at pharmacy on April 16, 2018.
Age: 83.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: I broke out in full blown shingles: severe pain down one side, across my hip, and down my leg. I was sick for 5 weeks - the identifying rash appeared around June 18, 2018. The SHINGRIX innoculation was given to me at pharmacy on April 16, 2018.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache, Injection site pain
Clinical narrative: Shivering, pain at site and in joints, headache.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site pain, Injection site rash, Injection site reaction
Clinical narrative: Injection site minimally sore next day and slight rash, sore to touch. After 2 days rash spread and sore to touch, but not painful. After 5 days, rash had spread over upper arm , and patient contacted doctor. She said it was SHINGLES, and prescribed Valtrex 1gr tid, and Acyclovir 5% Ointment 6x/d.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Asthenia, Dyspnoea, Fatigue, Injection site erythema
Clinical narrative: Systemic reaction. Injection site on arm swollen to 12cm, red,hot, hard, very painful, fever, body/joint aches, breathing challenges, fatigue and weakness.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Systemic reaction. Injection site on arm swollen to 12cm, red,hot, hard, very painful, fever, body/joint aches, breathing challenges, fatigue and weakness.
Age: 41.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Systemic reaction. Injection site on arm swollen to 12cm, red,hot, hard, very painful, fever, body/joint aches, breathing challenges, fatigue and weakness.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Hypoaesthesia, Mobility decreased, Muscular weakness
Clinical narrative: Moderate muscle pain and weakness in left shoulder area about 2 hours after injection. No redness or swelling. Excruciating should joint pain with weakness and numbness down the entire arm into the fingers 4 hours after injection. I was not able to move my left arm without assistance. I called my Dr. to notify them of my reaction. My Dr. had already left for the day. I  was told to go to the nearest ER. Went to Medical Center. Was given pain medication, anti nausea medication, and muscle relaxers. Was sent home. Today is 4 days post injection and my left arm is still very sore, weak, and numb. I do have some range of motion but it is painful (pain scale 1-10 = 7) to force my range of motion.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pain in extremity
Clinical narrative: Moderate muscle pain and weakness in left shoulder area about 2 hours after injection. No redness or swelling. Excruciating should joint pain with weakness and numbness down the entire arm into the fingers 4 hours after injection. I was not able to move my left arm without assistance. I called my Dr. to notify them of my reaction. My Dr. had already left for the day. I  was told to go to the nearest ER. Went to Medical Center. Was given pain medication, anti nausea medication, and muscle relaxers. Was sent home. Today is 4 days post injection and my left arm is still very sore, weak, and numb. I do have some range of motion but it is painful (pain scale 1-10 = 7) to force my range of motion.
Sex: M
Vaccine: PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable consumer. A 55-year-old male patient received PREVNAR 13, via an unspecified route of administration, on an unspecified date, at single dose, for immunisation. Relevant medical history and concomitant medications were not reported. The patient experienced puffy arm at injection site 2 days after vaccination. Outcome of the event was unknown.
Sex: U
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: Initial information received on 12-Jun-2018 regarding an unsolicited valid serious case received from a non-healthcare professional via other company (Mylan). This case involves a patient who experienced Guillain-Barre syndrome, while he/she received vaccine INFLUENZA VACCINE. The patient's past medical history, medical treatment, vaccination and family history were not provided. On an unknown date, the patient received a dose of suspect INFLUENZA VACCINE (Sanofi-Aventis' flu vaccine) produced by unknown manufacturer (batch number, expiry date, dose, dose in series, route and site of administration was not reported). The patient developed a serious the patient reportedly experienced Guillain-Barre syndrome, following the administration of INFLUENZA VACCINE. This event was assessed as medically significant. No Lab data was reported. It was not reported if the patient received a corrective treatment. Final diagnosis was Guillain-Barre syndrome. Outcome of event was not reported. List of documents held by the sender: None. Sender's Comments: This is poorly documented case which involves a 11 years old patient who received INFLUENZA vaccine (unknown manufacturer) and developed Guillain-Barre syndrome. Latency is unknown. Additionally, patient's medical history, medical condition at the time of vaccination, lab tests ruling out alternate etiologies and medical confirmation of the event were not provided. Based upon the reported information, the role of the vaccine cannot be assessed.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Rash pruritic, Scar
Clinical narrative: Patient a itchy, burning rash (ankles to knees, wrists to upper arms, and forehead) {Patient referred to rash looking like "tractor tracks"} [No rash on trunk] Patient's condition has improved but is still resolving: Patient still has some rash, minor burning, and minor itching (also, still some evidence of "tractor tracks").
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Nodule, Skin warm, Swelling
Clinical narrative: Swelling, Redness, Knot on arm about 2-3 inches wide, Warm area, Pain  - This began about 1/2 hour after vaccine given.
Age: 61.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Biopsy, Blood test normal, Erythema, Incomplete course of vaccination, Injection site pruritus
Clinical narrative: I was given number 1of2 SHINGRIX Vaccine at about 11AM. (I have NOT taken the 2nd shot; nor will I take it). I experienced a some itching at the site of the shot but later I woke up from sleeping with really bad itching and red lumps/bumps on my left arm, hands, back and neck. I took some BENADRYL. The BENADRYL helped a little bit. The following morning I called my doctor, and he called in a 5-day prescription of prednisone and told me to use a CORTIZONE cream. While taking the prednisone the itching subsided but the lumps and bumps did not go away. After I finished the prednisone the itching came back and more fresh lumps and bumps on arm, back, neck, ear, eye, face and head; bumps are painful and very itchy. Again, I called and got an appointment with Dr and he gave 5 more days of prednisone and a prescription CORTIZONE cream. Same results, while on the pills I was fine but after the pills, more itching. I then went to a minor emergency clinic and he examined me, gave me 9 day prescription of prednisone, a stronger cream and recommended XYZAL. He also recommended I go to a Dermatologist. I was fine while on the prednisone; however after prednisone was finished the itching returned within a day; new lumps and bumps all over. Dr recommended I take ALLEGRA during the day and BENADRYL at night. Dr. did a biopsy. He said the results showed it was a reaction to the SHINGRIX shot. Dr said maybe some of the medicines that I was on did not agree with the SHINGRIX shot so he took me off the Pravastatin and replaces with Ezetimibe. He also replaced the Lisinopril with Bisoprolol. He told me to continue the ALLEGRA/ZYRTEC and BENADRYL. Dr. gave me another prescription for a Clobetasol Propionate Emollient cream. He referred me to an allergy doctor. The bumps and lumps were still there. When I was able to get in to Dr., he did blood work to see if something else was going on, he said the results showed that all lab results were normal. Dr. recommended I see a dermatologist, Dr. She said it looked like bites to her, however she did another biopsy on a couple of the bumps/lumps. When I went back to see Dr., she said the pathologist wrote in bold letters "This is a reaction to the SHINGRIX Shot". She suggested I continue with the ALLEGRA/ZYRTEC and BENADRYL and the cream until they could figure out what to do next. She said she would call Drs. to see what to do next. Nothing really helps. The itching and breaking out with lumps and bumps still happen and it is quite annoying. What can we do to make it stop? It has been 4 months now. When will it go away?
Age: 61.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Mass, Middle insomnia, Pruritus, Rash, Rash erythematous
Clinical narrative: I was given number 1of2 SHINGRIX Vaccine at about 11AM. (I have NOT taken the 2nd shot; nor will I take it). I experienced a some itching at the site of the shot but later I woke up from sleeping with really bad itching and red lumps/bumps on my left arm, hands, back and neck. I took some BENADRYL. The BENADRYL helped a little bit. The following morning I called my doctor, and he called in a 5-day prescription of prednisone and told me to use a CORTIZONE cream. While taking the prednisone the itching subsided but the lumps and bumps did not go away. After I finished the prednisone the itching came back and more fresh lumps and bumps on arm, back, neck, ear, eye, face and head; bumps are painful and very itchy. Again, I called and got an appointment with Dr and he gave 5 more days of prednisone and a prescription CORTIZONE cream. Same results, while on the pills I was fine but after the pills, more itching. I then went to a minor emergency clinic and he examined me, gave me 9 day prescription of prednisone, a stronger cream and recommended XYZAL. He also recommended I go to a Dermatologist. I was fine while on the prednisone; however after prednisone was finished the itching returned within a day; new lumps and bumps all over. Dr recommended I take ALLEGRA during the day and BENADRYL at night. Dr. did a biopsy. He said the results showed it was a reaction to the SHINGRIX shot. Dr said maybe some of the medicines that I was on did not agree with the SHINGRIX shot so he took me off the Pravastatin and replaces with Ezetimibe. He also replaced the Lisinopril with Bisoprolol. He told me to continue the ALLEGRA/ZYRTEC and BENADRYL. Dr. gave me another prescription for a Clobetasol Propionate Emollient cream. He referred me to an allergy doctor. The bumps and lumps were still there. When I was able to get in to Dr., he did blood work to see if something else was going on, he said the results showed that all lab results were normal. Dr. recommended I see a dermatologist, Dr. She said it looked like bites to her, however she did another biopsy on a couple of the bumps/lumps. When I went back to see Dr., she said the pathologist wrote in bold letters "This is a reaction to the SHINGRIX Shot". She suggested I continue with the ALLEGRA/ZYRTEC and BENADRYL and the cream until they could figure out what to do next. She said she would call Drs. to see what to do next. Nothing really helps. The itching and breaking out with lumps and bumps still happen and it is quite annoying. What can we do to make it stop? It has been 4 months now. When will it go away?
Age: 61.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Rash generalised, Rash pruritic, Vaccination complication
Clinical narrative: I was given number 1of2 SHINGRIX Vaccine at about 11AM. (I have NOT taken the 2nd shot; nor will I take it). I experienced a some itching at the site of the shot but later I woke up from sleeping with really bad itching and red lumps/bumps on my left arm, hands, back and neck. I took some BENADRYL. The BENADRYL helped a little bit. The following morning I called my doctor, and he called in a 5-day prescription of prednisone and told me to use a CORTIZONE cream. While taking the prednisone the itching subsided but the lumps and bumps did not go away. After I finished the prednisone the itching came back and more fresh lumps and bumps on arm, back, neck, ear, eye, face and head; bumps are painful and very itchy. Again, I called and got an appointment with Dr and he gave 5 more days of prednisone and a prescription CORTIZONE cream. Same results, while on the pills I was fine but after the pills, more itching. I then went to a minor emergency clinic and he examined me, gave me 9 day prescription of prednisone, a stronger cream and recommended XYZAL. He also recommended I go to a Dermatologist. I was fine while on the prednisone; however after prednisone was finished the itching returned within a day; new lumps and bumps all over. Dr recommended I take ALLEGRA during the day and BENADRYL at night. Dr. did a biopsy. He said the results showed it was a reaction to the SHINGRIX shot. Dr said maybe some of the medicines that I was on did not agree with the SHINGRIX shot so he took me off the Pravastatin and replaces with Ezetimibe. He also replaced the Lisinopril with Bisoprolol. He told me to continue the ALLEGRA/ZYRTEC and BENADRYL. Dr. gave me another prescription for a Clobetasol Propionate Emollient cream. He referred me to an allergy doctor. The bumps and lumps were still there. When I was able to get in to Dr., he did blood work to see if something else was going on, he said the results showed that all lab results were normal. Dr. recommended I see a dermatologist, Dr. She said it looked like bites to her, however she did another biopsy on a couple of the bumps/lumps. When I went back to see Dr., she said the pathologist wrote in bold letters "This is a reaction to the SHINGRIX Shot". She suggested I continue with the ALLEGRA/ZYRTEC and BENADRYL and the cream until they could figure out what to do next. She said she would call Drs. to see what to do next. Nothing really helps. The itching and breaking out with lumps and bumps still happen and it is quite annoying. What can we do to make it stop? It has been 4 months now. When will it go away?
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain
Clinical narrative: Body aches, severe headache.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Skin lesion
Clinical narrative: Rash starting6/23 on torso and upper body, no rash on legs. Itching, up to 50 lesion on body with new lesion occur daily. Given ZYRTEC to help with itching.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Extra dose administered
Clinical narrative: Patient was vaccinated with PCV13 on 5/1/18 and again with PCV13 on 6/26/18. Patient has been notified of error and warned of the increased risk of side effects including arthrus reaction.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Pyrexia, Tremor
Clinical narrative: Fever, shaking, muscle aches, headache, shivering.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Rash a day and a half after receiving the vaccination. Rash is on chest and back, and patient communicated itchiness. Patient has been self-treating by applying hydrogen peroxide to affected areas, and is still experiencing rash symptoms (6 weeks after vaccination).
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Headache, Pain in extremity, Pyrexia
Clinical narrative: Left arm pain, chills and shivering, headache noted 30 minutes after vaccine administered, intense headache, developed fever tmax 101.9.
Age: 39.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Headache, Nausea, Pain
Clinical narrative: Severe body aches, severe chills, headache, nausea, extreme weakness. Started at night and  through out the night and is taking TYLENOL and Ibuprofen alternating, feeling a little better the next day. Patient refused any anti nausea medicine.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site vesicles
Clinical narrative: Swelling, redness with induration, blister around injection site 3.5 cm x 3cm.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Herpes zoster, Rash vesicular
Clinical narrative: Patient reported 36 hours of significant joint pain after administration. However, at this time he reports 30% of his body covered in blistering rash and getting diagnosis of shingles.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Pain, itching, swelling, warmth, erythema (width =3.25 in, length =5 in) at injection site. Pt has not used any home care treatments (ibuprofen, acetaminophen, ice-pack, hydrocortisone). Symptoms have not worsened or decreased since they first appeared.