chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. It was reported that on 05-FEB-2019, the patient received improperly stored dose of VARIVAX (lot # N017394, expiration date 07-JUN-2019) subcutaneously (dose and anatomical location were not reported) for prophylaxis. The dose of VARIVAX was exposed to a temperature excursion of 11.9 Farenheit (F) during a timeframe of 117 hours, which was detected by a digital data logger. The vaccine was reconstituted with properly stored sterile diluent. There were no previous temperature excursions. No adverse event. This is one of seven reports received from the same reporter.; Sender's Comments: US-009507513-1903USA001826: US-009507513-1903USA002595: US-009507513-1903USA002596: US-009507513-1903USA002597: US-009507513-1903USA002598: US-009507513-1903USA002600:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse, and refers to a patient of unknown age and gender. No information was provided regarding the patient's medical history, previous drug reactions, allergies, concurrent conditions or concomitant medications. It was reported that on 17-FEB-2019, the patient received improperly stored dose of VARIVAX (lot # N017394, expiration date 07-JUN-2019) subcutaneously (dose and anatomical location were not reported) for prophylaxis. The dose of VARIVAX was exposed to a temperature excursion of 11.9 Fahrenheit (F) during a timeframe of 117 hours, which was detected by a digital data logger. The vaccine was reconstituted with properly stored sterile diluent. There were no previous temperature excursions. No adverse event. This is one of seven reports received from the same reporter. Sender's Comments: US-009507513-1903USA001826: US-009507513-1903USA002595: US-009507513-1903USA002596: US-009507513-1903USA002597: US-009507513-1903USA002598: US-009507513-1903USA002599.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant regarding to a patient of unknown age and gender. The patient's concurrent conditions, historical conditions, drug reactions/allergies, past drugs and concomitant medications were unknown. On 05-MAR-2019 the patient was vaccinated with expired dose of PNEUMOVAX 23 (dose and frequency were unknown) (lot # N013541; expiry date: 23-JAN-2019) intramuscular for prophylaxis. No known adverse effects (no adverse event).
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. Information on pertinent medical history, drug reactions/allergies and concomitant medications were not reported. On 05-MAR-2019, the patient was vaccinated with a partial dose of PROQUAD (lot # R015739, expiry date 02-DEC-2019) along with a sterile diluent (# N035969, expiry date 18-APR-2020) for prophylaxis (dose, strength, vaccination site, route unspecified). No adverse events were reported. Product quality complaint (PQC) was not involved.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 70 year old patient of unknown gender. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On 06-JUN-2012,  the patient was vaccinated with the first dose of VARIVAX for prophylaxis (route of administration, anatomical location, lot # and expiration date were not reported). On an unknown date (reported as "now"), the patient would like to receive a second dose of VARIVAX. No adverse symptoms were reported.
Age: 0.08
Sex: M
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 8 week old male patient. The patient's medical history, concurrent conditions and concomitant therapies were not provided. On 10-OCT-2018, the patient was vaccinated with improperly stored doses of ROTATEQ lot number: N030150 (expiration date: 29-AUG-2019), orally, for prophylaxis (strength, dosage and frequency were not provided) and PEDVAXHIB lot number: N031492 (expiration date: 02-MAY-2020), for prophylaxis (strength, route, dosage and frequency were not provided). There was digital data logger involved. No adverse effects were reported. The storage characteristics were the following: Temperature: 0°C to 1°C (0.9°C) for 30 minutes. Previous temperature excursion: 0°C to 1°C (1.4°C) for 7 minutes. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1903USA003268.
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 25th February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a week 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 provided as follows: The age at vaccination was not reported. The patient experienced the common side effects post vaccination. The patient wanted to know how long the side effects would last.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a adult patient who received SHINGRIX for prophylaxis. On 25th February 2019 08:30, the patient received SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site itching, injection site rash, injection site swelling, injection site pain and fever. On an unknown date, the patient experienced injection site warmth. On an unknown date, the outcome of the injection site itching, injection site rash, injection site swelling, injection site pain, injection site warmth and fever were unknown. It was unknown if the reporter considered the injection site itching, injection site rash, injection site swelling, injection site pain, injection site warmth and fever 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 patient had small itchy rash, swelling, warmth, pain and a low fever of 99.0 about 2 inches in diameter around the injection site. The patient had send message to physician and was waiting to hear from them.
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a adult patient who received SHINGRIX for prophylaxis. On 25th February 2019 08:30, the patient received SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced injection site itching, injection site rash, injection site swelling, injection site pain and fever. On an unknown date, the patient experienced injection site warmth. On an unknown date, the outcome of the injection site itching, injection site rash, injection site swelling, injection site pain, injection site warmth and fever were unknown. It was unknown if the reporter considered the injection site itching, injection site rash, injection site swelling, injection site pain, injection site warmth and fever 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 patient had small itchy rash, swelling, warmth, pain and a low fever of 99.0 about 2 inches in diameter around the injection site. The patient had send message to physician and was waiting to hear from them.
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, unknown 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 provided as follows: The age at vaccination was not applicable for this report. The age group was not reported but was captured as adult as per vaccine indication. The reporter wanted to receive SHINGRIX, but heard about the side effects, known by several people who had bad events. The reporter stated that, it seemed that some doctors in the area were advising the patients to wait awhile. Even the local drug store had a list to get on, since they received little SHINGRIX each week and then all of a sudden, they tossed out their wait list. The reporter was suspicious of the issues, side effects. The reporter asked if their concerns were real or what exactly was happening with the vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Erythema, Feeling hot, Neuralgia, Pyrexia
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of neuropathic pain in a female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a day after receiving SHINGRIX, the patient experienced neuropathic pain, fever, erythema, chills and feeling hot. The patient was treated with TYLENOL. On an unknown date, the outcome of the neuropathic pain, fever, erythema, chills and feeling hot were recovering/resolving. It was unknown if the reporter considered the neuropathic pain, fever, erythema, chills and feeling hot to be related to SHINGRIX. Additional details were provided as follows: The reporter reported this case for his wife. The age at vaccination was not reported. The patient developed fever, neuropathic pain, redness, hot to touch chills within 10 hours of receiving the SHINGRIX. The symptoms subsided in 2 to 3 days. The patient stated that she took TYLENOL for the pain. The patient gave permission the contact pharmacy in Hospital. The patient did not have all the information and was reluctant to provide some due to a billing issue. No additional details were provided.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Pyrexia, Tension headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 68-year-old male patient who received SHINGRIX for prophylaxis. On 27th February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a day after receiving SHINGRIX, the patient experienced fever, shivering, stomach pain, headache and tension headache. On an unknown date, the outcome of the fever, shivering, stomach pain, headache and tension headache were not recovered/not resolved. It was unknown if the reporter considered the fever, shivering, stomach pain, headache and tension headache to be related to SHINGRIX. Additional details were provided as follows: The case was reported by the patient's wife who stated that the patient had fever, shivering, stomach ache, headache and he felt like wearing hat way too small. The reporter inquired if the patient could TYLENOL or something else for treatment. The reporter denied providing the prescribing physician's information.
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Limb mass, Pain in extremity, Purpura, Rash pustular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in May 2018, refer case US2019035155). In July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, pustular skin eruption, erythema, rash hemorrhagic and local swelling. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pustular skin eruption, erythema and rash hemorrhagic were not recovered/not resolved and the outcome of the local swelling was unknown. It was unknown if the reporter considered the pain in arm, pustular skin eruption, erythema, rash hemorrhagic and local swelling to be related to SHINGRIX. Additional details were provided as follows: The patient had the second dose in July 2018. She reported that her arm hurt for a couple of weeks after shot. She also had a lump in her arm after the second shot. She could not remember which arm. Her face broke out with little pustules 2 to 3 weeks after receiving the shot. At first she thought it was acne but it was not. It resolved and then came back. The pustules presented again the previous week before the date of reporting and were still present. The break out was worse after the 2nd shot. She still had a red mark on my one cheek that bled. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX (1st dose received in May 2018, refer case US2019035155). In July 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm, pustular skin eruption, erythema, rash hemorrhagic and local swelling. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pustular skin eruption, erythema and rash hemorrhagic were not recovered/not resolved and the outcome of the local swelling was unknown. It was unknown if the reporter considered the pain in arm, pustular skin eruption, erythema, rash hemorrhagic and local swelling to be related to SHINGRIX. Additional details were provided as follows: The patient had the second dose in July 2018. She reported that her arm hurt for a couple of weeks after shot. She also had a lump in her arm after the second shot. She could not remember which arm. Her face broke out with little pustules 2 to 3 weeks after receiving the shot. At first she thought it was acne but it was not. It resolved and then came back. The pustules presented again the previous week before the date of reporting and were still present. The break out was worse after the 2nd shot. She still had a red mark on my one cheek that bled. The reporter consented to follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Product administered at inappropriate site, Vaccine positive rechallenge
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of erythema in a 75-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of erythema (received 1st dose, refer case US2019036988). In February 2019, the patient received the 2nd dose of SHINGRIX. In February 2019, less than a month after receiving SHINGRIX, the patient experienced erythema and vaccine administered at inappropriate site. Rechallenge with SHINGRIX was positive. On an unknown date, the outcome of the erythema was recovered/resolved and the outcome of the vaccine administered at inappropriate site was unknown. It was unknown if the reporter considered the erythema to be related to SHINGRIX. Additional details were provided as follows: The patient received 2nd dose within the past 2 weeks, but she insisted that it be injected in her buttock instead of her arm, which led to vaccine administered at inappropriate site. She had redness as big as a cantaloupe on her rear end after the 2nd dose. The reporter consented to follow up. Emergency room (ER) visit was required.
Sex: U
Vaccine: MEN
Symptoms: Meningococcal infection
Clinical narrative: This case was reported in a literature article and described the occurrence of meningococcal infection in a subject who received Meningococcal B Recom vaccine + AlOH + OMV for prophylaxis. On an unknown date, 6 days after receiving Meningococcal B Recom vaccine + AlOH + OMV, the subject developed meningococcal infection. Serious criteria included GSK medically significant. The outcome of meningococcal infection was unknown. The investigator considered that there was a reasonable possibility that the meningococcal infection may have been caused by Meningococcal B Recom vaccine + AlOH + OMV. Additional information was provided. This case was reported in a literature article and described the occurrence of meningococcal B infection in a patient of unspecified age and gender who was vaccinated with unspecified meningococcal B (MenB) vaccine (manufacturer unknown) for prophylaxis. The patient corresponds to table 2 of this literature article. The patient was a part of the study that summarized the university-based outbreaks of meningococcal disease caused by serogroup B in the years following MenB vaccine availability (2013-2018) and described the resulting MenB vaccination responses. The patient belonged to university outbreak during January to May 2015. No information on patient's family or medical history or concurrent condition or concomitant medication was provided. On an unspecified date, the patient received 1 dose of unspecified MenB vaccine (administration route and site unspecified; batch number not provided). Age of vaccination was not provided. On an unspecified date, 6 days after vaccination, the patient developed meningococcal B disease. Treatment was unknown. The outcome of the event was not reported. The author did not comment on the relationship between the event of meningococcal B disease and unspecified meningococcal B vaccine. The author stated, "Achieving high MenB vaccination coverage is necessary to help protect persons during outbreaks of meningococcal disease caused by serogroup B. Efforts are under way to better understand MenB vaccine effectiveness and duration of protection, MenB vaccine strain coverage, and current risk factors for meningococcal disease among university students. This information, along with lessons learned when implementing MenB vaccination campaigns, could help guide and improve responses to future outbreaks." This is 1 of the 2 valid cases reported in the same literature article.
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash pustular
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a elderly female patient who received SHINGRIX for prophylaxis. In May 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced pain in arm and pustular skin eruption. On an unknown date, the outcome of the pain in arm was recovered/resolved and the outcome of the pustular skin eruption was not recovered/not resolved. It was unknown if the reporter considered the pain in arm and pustular skin eruption to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. She reported that her arm hurt for a couple of weeks after shot. Her face broke out with little pustules 2 to 3 weeks after receiving the shots. At first she thought it was acne but it was not resolved and then came back. For tolerance to 2nd dose of SHINGRIX, refer case US2019GSK039410.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of influenza-like symptoms in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received SHINGRIX, 6 months before the date of reporting. The patient felt like she was coming down with the flu for about the first week after the dose. The patient did not want to provide her address for follow up.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Immediate post-injection reaction, Injection site pain, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tendon rupture in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 6th September 2018, the patient received the 1st dose of SHINGRIX. On 6th September 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and erythema. On 26th October 2018, the patient experienced tendon rupture. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the tendon rupture and injection site pain were not recovered/not resolved and the outcome of the erythema was recovered/resolved and the outcome of the pain was unknown. It was unknown if the reporter considered the tendon rupture, injection site pain, erythema and pain to be related to SHINGRIX. Additional details were provided as follows: The patient immediately had soreness at the injection site and she also developed redness. The redness did go away, but the soreness lingered. She had an magnetic resonance and was diagnosed with a ruptured tendon. She was still experiencing pain from the ruptured tendon. The reporter consented to follow up. Emergency room (ER) visit was required. For tolerance to 2nd dose, refer case US2019GSK040396.
Age: 75.0
Sex: F
Vaccine: VARZOS
Symptoms: Tendon rupture
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of tendon rupture in a 75-year-old female patient who received SHINGRIX for prophylaxis. On 6th September 2018, the patient received the 1st dose of SHINGRIX. On 6th September 2018, immediately after receiving SHINGRIX, the patient experienced injection site pain and erythema. On 26th October 2018, the patient experienced tendon rupture. On an unknown date, the patient experienced pain. On an unknown date, the outcome of the tendon rupture and injection site pain were not recovered/not resolved and the outcome of the erythema was recovered/resolved and the outcome of the pain was unknown. It was unknown if the reporter considered the tendon rupture, injection site pain, erythema and pain to be related to SHINGRIX. Additional details were provided as follows: The patient immediately had soreness at the injection site and she also developed redness. The redness did go away, but the soreness lingered. She had an magnetic resonance and was diagnosed with a ruptured tendon. She was still experiencing pain from the ruptured tendon. The reporter consented to follow up. Emergency room (ER) visit was required. For tolerance to 2nd dose, refer case US2019GSK040396.
Age: 74.0
Sex: M
Vaccine: 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 74-year-old male patient who received SHINGRIX for prophylaxis. In October 2018, the patient received SHINGRIX. In October 2018, 1 day after receiving SHINGRIX, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was recovered/resolved. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The case was reported by patient's husband. The patient received vaccine on left arm. The patient experienced sore arm for a couple of days. The reporter consented to follow up. The caller also experienced a bad reaction that put her down for a few days and called the Risk Compliance to report in detail. The case has been linked with case US2018167868 reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of muscle pain in a adult female patient who received SHINGRIX for prophylaxis. On 27th February 2019, the patient received SHINGRIX. In February 2019, less than a week after receiving SHINGRIX, the patient experienced muscle pain, headache and tiredness. On an unknown date, the outcome of the muscle pain, headache and tiredness were unknown. It was unknown if the reporter considered the muscle pain, headache and tiredness to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experiencing muscle aches, headache, and tiredness. The reporter consented to follow up. The caller hung up on me after answering the PI question. No details to adverse drug event.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 74-year-old female patient who received SHINGRIX (batch number MG42F, expiry date 29th May 2021) for prophylaxis. On 27th February 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 28th February 2019, 1 days after receiving SHINGRIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to SHINGRIX. Additional details were provided as follows: The patient received vaccine in right deltoid. The patient woke up with a rash on their right forearm post vaccination. Unable to obtain any additional information. The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discolouration, Injection site erythema, Injection site induration, Injection site reaction, Injection site swelling
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a 59-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number 59TS2, expiry date 31st May 2019) for prophylaxis. Previously administered products included INFLUENZA VACCINE (received on an unknown date, without any issues). On 25th February 2019, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular). In February 2019, less than a week after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced erythema of extremities, skin blotches, induration, swelling arm and injection site discoloration. On an unknown date, the outcome of the erythema of extremities, skin blotches, induration, swelling arm and injection site discoloration were recovered/resolved. It was unknown if the reporter considered the erythema of extremities, skin blotches, induration, swelling arm and injection site discoloration to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient received FLULAVAL QUADRIVALENT 2018-2019 season on left arm. The registered nurse reported that her clinic administered the FLUARIX QUADRIVALENT and the patient experienced a red and blotchy area from her left shoulder to her elbow that was hard and swollen. The injection site was white, elevated and hard on her left upper arm. She went to her physician on the day after her injection for allergy injections for seasonal and environmental allergies and her physician noticed the red area. The patient has had no issues with the flu vaccine in the past and she regularly gets the flu vaccine, however, she didn't get the vaccine last year. The symptoms are mostly resolved. Consented to follow up was provided.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Rash macular
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of erythema of extremities in a 59-year-old female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number 59TS2, expiry date 31st May 2019) for prophylaxis. Previously administered products included INFLUENZA VACCINE (received on an unknown date, without any issues). On 25th February 2019, the patient received FLULAVAL QUADRIVALENT 2018-2019 season (intramuscular). In February 2019, less than a week after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced erythema of extremities, skin blotches, induration, swelling arm and injection site discoloration. On an unknown date, the outcome of the erythema of extremities, skin blotches, induration, swelling arm and injection site discoloration were recovered/resolved. It was unknown if the reporter considered the erythema of extremities, skin blotches, induration, swelling arm and injection site discoloration to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: The patient received FLULAVAL QUADRIVALENT 2018-2019 season on left arm. The registered nurse reported that her clinic administered the FLUARIX QUADRIVALENT and the patient experienced a red and blotchy area from her left shoulder to her elbow that was hard and swollen. The injection site was white, elevated and hard on her left upper arm. She went to her physician on the day after her injection for allergy injections for seasonal and environmental allergies and her physician noticed the red area. The patient has had no issues with the flu vaccine in the past and she regularly gets the flu vaccine, however, she didn't get the vaccine last year. The symptoms are mostly resolved. Consented to follow up was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a adult female patient who received SHINGRIX (batch number D9P5X, expiry date 19th April 2021) 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 shingles. On an unknown date, the outcome of the shingles was unknown. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported the patient experiencing an episode of shingles that was worse than the patient's primary occurrence after receiving the first dose of SHINGRIX. Agent attempted to collect full demographic and vaccine administration address however healthcare professional (HCP) did not provide.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Infection
Clinical narrative: Suspected infection after vaccination administered on Monday and spreading past demarcation line but was not discharged on antibiotics. Given clindamycin prescription did improve.
Sex: F
Vaccine: VARZOS
Symptoms: Meralgia paraesthetica, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of leg pain in a elderly female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 2nd dose of SHINGRIX. On an unknown date, unknown after receiving SHINGRIX, the patient experienced leg pain and meralgia paresthetica. On an unknown date, the outcome of the leg pain and meralgia paresthetica were unknown. It was unknown if the reporter considered the leg pain and meralgia paresthetica to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient was a female from 70 to 74 years old. The patient mentioned having the two shingles shots (assumed to be SHINGRIX). The patient given the 2nd dose of SHINGRIX either at one pharmacy or another pharmacy, she experienced a pain in her leg from 4 inches above her knee to her hip. The patient's physician told her it may not be from the shingles shot but could be due to possible meralgia paresthetica due to the lateral, femoral, cutaneous nerve coming out of the pelvis. This was all the information the caller provided.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Blood pressure increased, Bone pain, Head discomfort, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder discomfort in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a month after receiving SHINGRIX, the patient experienced shoulder discomfort, back pain, shoulder pain, head pressure, headache, sinusitis, increased blood pressure, unwell, bone pain and ill-defined disorder. On an unknown date, the outcome of the shoulder discomfort, back pain, shoulder pain, head pressure, headache, sinusitis, increased blood pressure, unwell, bone pain and ill-defined disorder were recovered/resolved. It was unknown if the reporter considered the shoulder discomfort, back pain, shoulder pain, head pressure, headache, sinusitis, increased blood pressure, unwell, bone pain and ill-defined disorder to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient reported that he had a reaction and he was not well. The patient experienced discomfort from his left shoulder which moved to his right shoulder and then on to his collarbone. The patient also had back pain and medical issues that lasted for several weeks and months. The patient reported pain in his back and shoulder and he had head pressure with headaches and sinus issues. The patient also experienced elevated blood pressure and he saw a cardiologist and neurologist and they found nothing. These symptoms all started during September and into October and they had all fully resolved at the time of reporting. The reporter gave consent to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Ill-defined disorder, Malaise, Musculoskeletal discomfort, Musculoskeletal pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shoulder discomfort in a 63-year-old male patient who received SHINGRIX for prophylaxis. On 31st August 2018, the patient received the 1st dose of SHINGRIX. In September 2018, less than a month after receiving SHINGRIX, the patient experienced shoulder discomfort, back pain, shoulder pain, head pressure, headache, sinusitis, increased blood pressure, unwell, bone pain and ill-defined disorder. On an unknown date, the outcome of the shoulder discomfort, back pain, shoulder pain, head pressure, headache, sinusitis, increased blood pressure, unwell, bone pain and ill-defined disorder were recovered/resolved. It was unknown if the reporter considered the shoulder discomfort, back pain, shoulder pain, head pressure, headache, sinusitis, increased blood pressure, unwell, bone pain and ill-defined disorder to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the left arm. The patient reported that he had a reaction and he was not well. The patient experienced discomfort from his left shoulder which moved to his right shoulder and then on to his collarbone. The patient also had back pain and medical issues that lasted for several weeks and months. The patient reported pain in his back and shoulder and he had head pressure with headaches and sinus issues. The patient also experienced elevated blood pressure and he saw a cardiologist and neurologist and they found nothing. These symptoms all started during September and into October and they had all fully resolved at the time of reporting. The reporter gave consent to follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Autoimmune disorder, Pemphigoid
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of benign mucous membrane pemphigoid in a elderly female patient who received SHINGRIX (batch number 992H3, expiry date 31st May 2021) for prophylaxis. In January 2019, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced benign mucous membrane pemphigoid (serious criteria GSK medically significant). On an unknown date, the outcome of the benign mucous membrane pemphigoid was unknown. It was unknown if the reporter considered the benign mucous membrane pemphigoid to be related to SHINGRIX. Additional details were provided as follows: The patient on an unknown date was recently diagnosed with pemphigoid of gingival mucosa, an autoimmune disease. The patient did not feel that this was due to SHINGRIX.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever (maximum of 101 degrees F) lasting approximately two days, treated using acetaminophen.
Age: 15.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered
Clinical narrative: 15 year old administered adult dose of Hepatitis A vaccine instead of pediatric/adolescent dose. Voice message left for parent asking them to call back. Manufacturer contacted and awaiting information. No reported concerns currently.
Sex: U
Vaccine: VARZOS
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling cold, Headache, Insomnia, Myalgia, Pain
Clinical narrative: Couldn't sleep at night, freezing cold (despite thermal underwear and down comforter), muscle pain for 2-3 hours, then given TYLENOL, melatonin, extra sweater and fleece pants--slept, woke up with headache and body aches for entire next day.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Bed rest, Blood test, Delivery, Exposure during pregnancy, Haemorrhage in pregnancy
Clinical narrative: A month after my medically coerced Tdap vaccination, I went into pre-term labor at 33 weeks on Sep 23rd 2018. I was rushed to the emergency room with heavy bleeding and cramping. I was admitted for 24 hours for observation and was given medication to stop the contractions. The cause of the bleeding was a partial abruption of my placenta and I was told that I had to be in bed rest for the remainder of my pregnancy. I had to stop working and subsequently lost thousands of dollars. I continued to bleed throughout the rest of my pregnancy. In addition, after the vaccine my baby stopped growing at a normal rate. She was healthy but small so they allowed me to go to term. I gave birth on my due date to a full term baby weighing only 4.8lbs. My placenta was heavily calcified and blanched.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired work ability, Muscle spasms, Placental disorder, Premature labour, Premature separation of placenta
Clinical narrative: A month after my medically coerced Tdap vaccination, I went into pre-term labor at 33 weeks on Sep 23rd 2018. I was rushed to the emergency room with heavy bleeding and cramping. I was admitted for 24 hours for observation and was given medication to stop the contractions. The cause of the bleeding was a partial abruption of my placenta and I was told that I had to be in bed rest for the remainder of my pregnancy. I had to stop working and subsequently lost thousands of dollars. I continued to bleed throughout the rest of my pregnancy. In addition, after the vaccine my baby stopped growing at a normal rate. She was healthy but small so they allowed me to go to term. I gave birth on my due date to a full term baby weighing only 4.8lbs. My placenta was heavily calcified and blanched.
Age: 22.0
Sex: F
Vaccine: TDAP
Symptoms: Ultrasound antenatal screen
Clinical narrative: A month after my medically coerced Tdap vaccination, I went into pre-term labor at 33 weeks on Sep 23rd 2018. I was rushed to the emergency room with heavy bleeding and cramping. I was admitted for 24 hours for observation and was given medication to stop the contractions. The cause of the bleeding was a partial abruption of my placenta and I was told that I had to be in bed rest for the remainder of my pregnancy. I had to stop working and subsequently lost thousands of dollars. I continued to bleed throughout the rest of my pregnancy. In addition, after the vaccine my baby stopped growing at a normal rate. She was healthy but small so they allowed me to go to term. I gave birth on my due date to a full term baby weighing only 4.8lbs. My placenta was heavily calcified and blanched.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction, Pain, Rash erythematous
Clinical narrative: PT DESCRIBES AFTER INJECTION SHE GOT A RED SPOTTY RASH- FROM IJECTION SITE TO ELBOW. ACHEY FOR A COUPLE DAYS.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Erythema and induration at the injection site right thigh. Nontender.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, MMR
Symptoms: Gait disturbance, Immediate post-injection reaction, Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Incident happened 9/15/18. Mom did not report until 12/4/18. Mom states patient was walking around "like a drunken uncle" and would repeatedly just collapse 4 days after vaccines were given. Mom could not remember which leg had redness and swelling at shot visit - but states one leg was red and swollen instantaneously, so she is nervous that this was an allergic reaction. She thinks it was MMR because patient had already had PREVNAR x 3. Making you aware B/C she stated she will be very nervous to get second MMR when patient turns four. 03/05/19 (Tue Mar 5) 09:42 PM: mom reports that at patient's 12 month visit she has a a localized reaction to the MMR and we had her wait here for about 20 minutes, then reports that over the next couple of days patient's gait was "wobbly" and she had difficulty holding weight on her legs - although my notes do not state that she was walking...mom would like to report this to VAERS, but likely too late...she does not want to do anymore MMR's...I told her that based on that story, I WOULD NOT write a medical exemption, but we could check her titers. Please see if we have documentation that she had hives with the vaccines.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, MMR
Symptoms: Syncope, Weight bearing difficulty
Clinical narrative: Incident happened 9/15/18. Mom did not report until 12/4/18. Mom states patient was walking around "like a drunken uncle" and would repeatedly just collapse 4 days after vaccines were given. Mom could not remember which leg had redness and swelling at shot visit - but states one leg was red and swollen instantaneously, so she is nervous that this was an allergic reaction. She thinks it was MMR because patient had already had PREVNAR x 3. Making you aware B/C she stated she will be very nervous to get second MMR when patient turns four. 03/05/19 (Tue Mar 5) 09:42 PM: mom reports that at patient's 12 month visit she has a a localized reaction to the MMR and we had her wait here for about 20 minutes, then reports that over the next couple of days patient's gait was "wobbly" and she had difficulty holding weight on her legs - although my notes do not state that she was walking...mom would like to report this to VAERS, but likely too late...she does not want to do anymore MMR's...I told her that based on that story, I WOULD NOT write a medical exemption, but we could check her titers. Please see if we have documentation that she had hives with the vaccines.
Age: 1.0
Sex: F
Vaccine: MMR, PNC13, MMR
Symptoms: Balance disorder, Confusional state, Fall, Muscular weakness
Clinical narrative: Incident happened 9/15/18. Mom did not report until 12/4/18. Mom states patient was walking around "like a drunken uncle" and would repeatedly just collapse 4 days after vaccines were given. Mom could not remember which leg had redness and swelling at shot visit - but states one leg was red and swollen instantaneously, so she is nervous that this was an allergic reaction. She thinks it was MMR because patient had already had PREVNAR x 3. Making you aware B/C she stated she will be very nervous to get second MMR when patient turns four. 03/05/19 (Tue Mar 5) 09:42 PM: mom reports that at patient's 12 month visit she has a a localized reaction to the MMR and we had her wait here for about 20 minutes, then reports that over the next couple of days patient's gait was "wobbly" and she had difficulty holding weight on her legs - although my notes do not state that she was walking...mom would like to report this to VAERS, but likely too late...she does not want to do anymore MMR's...I told her that based on that story, I WOULD NOT write a medical exemption, but we could check her titers. Please see if we have documentation that she had hives with the vaccines.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site rash
Clinical narrative: Rash at injection site.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Insomnia, Nocturia, Pain
Clinical narrative: Fever, chills, shivering/shaking, extreme body aches all over, occasional sharp, stabbing pains in feet and legs from 10:00 pm - 10:00 am. Felt like I had the Flu. Took a very hot shower and went to bed. Did not sleep much. Extreme pain. Up about 8 times to urinate, very unusual. At noon I was able to eat and felt almost fine at 1:00 pm.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Tremor
Clinical narrative: Fever, chills, shivering/shaking, extreme body aches all over, occasional sharp, stabbing pains in feet and legs from 10:00 pm - 10:00 am. Felt like I had the Flu. Took a very hot shower and went to bed. Did not sleep much. Extreme pain. Up about 8 times to urinate, very unusual. At noon I was able to eat and felt almost fine at 1:00 pm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Redness swelling hot to touch at and around injection site. Down to about halfway to elbow. Pt taking TYLENOL and will add some antihistamine and follow up with MD.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Pain in extremity, Swelling
Clinical narrative: Left arm pain, swelling of left deltoid, left axilla, left side/chest.
Age: 2.0
Sex: M
Vaccine: DTAP, HEPA, IPV, PNC13
Symptoms: Injection site erythema, Injection site swelling, Rash generalised, Urticaria
Clinical narrative: Patient present back to the office 2 days later (2/22/2019) with a hives looking rash all over the entire body with significant swelling and redness on both thighs at the injection sites.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Biopsy skin abnormal, Herpes zoster, Rash, Tenderness
Clinical narrative: Two days after vaccination developed mildly tender rash on R anteromedial thigh.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Muscle discomfort
Clinical narrative: Chills, back hurts, muscles feel strange, very tired.