chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Skin discolouration, Skin exfoliation
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of blister in a 56-year-old female patient who received SHINGRIX (batch number B327C, expiry date 4th July 2020). Concurrent medical conditions included asthma. Concomitant products included amlodipine, Losartan, monteukast sodium, Rosuvastation, carvedilol, fluconazole, esomeprazole, LINZESS, NORCO, PROVIGIL, Dicyclomine and tizanidine. On 17th April 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In April 2018, less than a month after receiving SHINGRIX, the patient experienced blister, skin discoloration and skin peeling. On an unknown date, the outcome of the blister, skin discoloration and skin peeling were recovering/resolving. The reporter considered the blister, skin discoloration and skin peeling to be possibly related to SHINGRIX. Additional details were provided as follows: The patient was administered SHINGRIX in the left arm. The pharmacist reported that the patient developed 3 fluid filled blisters on her arm after receiving SHINGRIX. The patient was seen at the pharmacy on 27th April 2018 and the blisters were no longer filled with fluid, but there was peeling and discolored skin where they had been.
Sex: M
Vaccine: FLU4
Symptoms: Condition aggravated, Pain, Tendonitis
Clinical narrative: This case was reported by a consumer and described the occurrence of pain in a adult male patient who received Influenza vaccine Quadrivalent. Concurrent medical conditions included tendonitis (diagnosed 6 year ago). On an unknown date, the patient received Influenza vaccine Quadrivalent. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent, the patient experienced pain and tendonitis exacerbated. On an unknown date, the outcome of the pain was recovered/resolved and the outcome of the tendonitis exacerbated was unknown. The reporter considered the pain to be related to Influenza vaccine Quadrivalent. It was unknown if the reporter considered the tendonitis exacerbated to be related to Influenza vaccine Quadrivalent. Additional details were provided as follows: The age at vaccination was not reported. In 2016, the patient reported that he received a flu shot in his shoulder and he experienced 6 to 9 months of pain. The patient was diagnosed with tendonitis 6 years ago and he believed that the flu shot also aggravated his tendonitis condition. The patient had to disconnected and could not provide additional details.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus
Clinical narrative: Redness 5x3", and some itching.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema, Injection site pain, Myalgia, Paraesthesia
Clinical narrative: Caller: parent called at 3:09 PM (04/04/2018). Call Taken By: RN. Concerns/Comments: Spoke with Mother, states patients arm is red and tender at the injection site after her first dose of Bexsero yesterday/ mom also states that her arm "feels tingly" and her muscle is sore. I explained that a sore injection site can occur for 1-2 days in 50% of patients and joint pain is common in 20% of patients after this vaccine. Mom denies any discharge/streaking at the site/ patient also denies any fever. Offered Mother appt for today but she would like to monitor patient, advised mother to use a cold ice pack for pain for 20 mins each hour, and TYLENOL or ADVIL can also be given as needed. Advised Mother to call back if redness becomes larger/ pain, swelling, or redness gets worse after 3 days or a fever starts after 2 days.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Dyspnoea, Hallucination, Influenza, Injection site reaction
Clinical narrative: Pt reports altered mental status, hallucinations, shortness of breath and anxiety...reports frozen left shoulder in addition to flu symptoms.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Mental status changes, Periarthritis
Clinical narrative: Pt reports altered mental status, hallucinations, shortness of breath and anxiety...reports frozen left shoulder in addition to flu symptoms.
Age: 5.0
Sex: M
Vaccine: IPV
Symptoms: Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Developed a rash the night after receiving the vaccine. Seen at urgent care the next day, diagnosed as hives. Based on pictures, rash did appear to look like coalescing hives on torso. Rash got a little better, but then seemed to spread again to include face, arms and legs. When I saw him 3 days after the symptoms started, the rash consisted of circular lesions with erythematous borders and central clearing of varying sizes present on torso, arms, legs, neck. Erythematous areas do blanch and some areas are coalescing. Sparing palms/soles. The rash was itchy, but not painful and he was taking BENADRYL for it. No fever, joint pain, mucosal involvement, etc.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Hypersensitivity, Injected limb mobility decreased, Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Mom called 5/3/18 the next day after vaccines were given and states Patient right upper arm was swollen, warm, and itchy. Advised parent to give BENADRYL, Ibuprofen, and cold compress and told the area may get worse before it is better but should improve over the next 3-4 days. Advised to call back if symptoms are worsening or not improving with treatment advised. Mom called 5/5/18 and states patient is unable to move his arm and swelling is worse. Dr on call advised mom to take patient to the ER. ER diagnosed patient with post-immunization reaction T88.1xxa and allergic reaction T78.40xa. Today patient is doing well with some mild redness in the area.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site warmth
Clinical narrative: Mom called 5/3/18 the next day after vaccines were given and states Patient right upper arm was swollen, warm, and itchy. Advised parent to give BENADRYL, Ibuprofen, and cold compress and told the area may get worse before it is better but should improve over the next 3-4 days. Advised to call back if symptoms are worsening or not improving with treatment advised. Mom called 5/5/18 and states patient is unable to move his arm and swelling is worse. Dr on call advised mom to take patient to the ER. ER diagnosed patient with post-immunization reaction T88.1xxa and allergic reaction T78.40xa. Today patient is doing well with some mild redness in the area.
Age: 36.0
Sex: M
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient informed his PCP that he has had ongoing shingles and is requesting the vaccine. Patient is currently homeless and is not receiving the care that he needs. PCP felt that even though patient is only 36 years of age he needed to be vaccinated against shingles before leaving the building, even though the CDC does not recommend it. Patient was given vaccine before leaving the building.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Chills, Fatigue, Headache, Influenza virus test negative, Myalgia
Clinical narrative: Patient was in the office for PE on 4/30/18, at around 9:30 am she received both vaccines as noted above in separate deltoid muscles. She developed a fever, Tmax 103.7, headache, chills, myalgias, fatigue at around 5 pm. She was seen in the office on 5/1/18 with persistent fever (103) and mild muscle aches. Influenza test was negative.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Pyrexia
Clinical narrative: Patient was in the office for PE on 4/30/18, at around 9:30 am she received both vaccines as noted above in separate deltoid muscles. She developed a fever, Tmax 103.7, headache, chills, myalgias, fatigue at around 5 pm. She was seen in the office on 5/1/18 with persistent fever (103) and mild muscle aches. Influenza test was negative.
Sex: U
Vaccine: TDAP
Symptoms: Pertussis, Vaccination failure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in an unspecified number of patients who received BOOSTRIX. On an unknown date, the patients received BOOSTRIX at an unknown dose. On an unknown date, unknown after receiving BOOSTRIX, the patients experienced vaccination failure (serious criteria GSK medically significant) and whooping cough (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure and whooping cough were unknown. It was unknown if the reporter considered the vaccination failure and whooping cough to be related to BOOSTRIX. Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that, while working in the MD office, (unknown if reporter was healthcare professional), witnessed lack of effect and diagnosis of whooping cough in patients who previously received BOOSTRIX. The specific number of patients was not reported. No further details were known.  This case was considered as suspected vaccination failure since the status of completion of primary vaccination schedule, laboratory confirmation of the disease and time to onset for the event were unknown.
Age: 31.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin, No adverse event, Pregnancy test urine positive
Clinical narrative: Patient was given VZV vaccine after she answered no to pre-screening questions. However, a urine pregnancy test done after vaccine given was positive. (few days after). Pt is about 5 weeks pregnant. Denies any reaction.
Sex: F
Vaccine: MENB
Symptoms: Chills, Dizziness, Headache, Influenza virus test negative, Pyrexia
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer Sales Representative. A 17-year-old female patient received on 01May2018 second dose of TRUMENBA (batch number S26985) at single dose for immunization. First dose was administered for immunization on an unspecified date. Medical history and concomitant medications were not reported. She came back to the office on 02May2018 with fever, chills, headaches, feeling faint and was checked for flu which was negative. Outcome was not reported.
Sex: U
Vaccine: MENB
Symptoms: Chills, Pain
Clinical narrative: This is a spontaneous report obtained from a contactable physician through a Pfizer sales representative. This physician reported similar events for four patients. This is for the 4th of the four reports. A patient of an unspecified age, gender, race and ethnicity received TRUMENBA on an unknown date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, after the vaccination, the patient experienced body ache and chills. Clinical outcome of the events was unknown at time of this report. The information on the lot number has been requested. Sender's Comments: Linked Report(s) : US-PFIZER INC-2018186943 same reporter/drug/event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Malaise
Clinical narrative: This is a spontaneous report from a non-contactable pharmacist via a Pfizer sales representative. A patient of unspecified age, ethnicity, and gender received PREVNAR 13 via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. The pharmacist reported that after they gave the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein), the patient fell sick on an unspecified date. Outcome of the event was unknown. No follow-up attempts are possible, information about batch number cannot be obtained. No further information is expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Skin disorder
Clinical narrative: Had a small breakout of shingles rash/blisters 4-18-18. I had major shingles breakout last June. Went to emergency room 7-3-17. Had blisters from my front right side around to spine, above and below my waist. Was prescribed - Lido/Prilocn 2.5 - 2.5% creact, Ondansetron ODT 4mg, Naproxen - 500mg, Oxycod/Acetamin 5 - 325 mg. Took 4 1/2 months to clear up. My skin still is not healthy.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Limb discomfort, Pain in extremity, Vision blurred
Clinical narrative: Pain in both arms, feel heavy. Vision is blurred. Headache-consistent.
Age: 10.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site plaque, Injection site warmth
Clinical narrative: 6 x 6.5 cm erythematous, warm, slightly tender plaque on left upper arm.
Sex: F
Vaccine: TDAP
Symptoms: Musculoskeletal stiffness, Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a adult female patient who received dTpa vaccine. On an unknown date, the patient received dTpa vaccine (intramuscular). On an unknown date, unknown after receiving dTpa vaccine, the patient experienced fever and limbs stiffness. On an unknown date, the outcome of the fever and limbs stiffness were unknown. It was unknown if the reporter considered the fever and limbs stiffness to be related to dTpa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The caller reported that his sister and their two kids had a Tdap (unknown date; unknown manufacturer) and experienced the side effects. The caller reported that she was not close to her sister or their kids and had no further information to report. This case has been linked to the case US2018074039 and US2018074038, reported by the same reporter.
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of fever in a 2-year-old female patient who received DTPa vaccine. On an unknown date, the patient received DTPa vaccine (intramuscular). On an unknown date, less than a year after receiving DTPa vaccine, the patient experienced fever. On an unknown date, the outcome of the fever was unknown. It was unknown if the reporter considered the fever to be related to DTPa vaccine. Additional details were provided as follows: The age at vaccination was not reported. The caller reported that her sister had a Tdap (unknown date; unknown manufacturer) and experienced the side effects. The caller reported that she was not close to her sister and had no further information to report. This case has been linked to US2018074039 and US2018074038. reported by the same reporter for their kids.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness, 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 male patient who received SHINGRIX. 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 and influenza-like symptoms. On an unknown date, the outcome of the pain in arm and influenza-like symptoms were unknown. It was unknown if the reporter considered the pain in arm and influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. Inside sales team took information from the health care professional, medical information never spoke to him and he did not want to be called back. The health care professional was the patient. Everything inside sales was reported but very limited information was available.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Redness on left arm.
Age: 0.08
Sex: M
Vaccine: DTAP, HIBV, IPV, PNC13, RV5
Symptoms: Death
Clinical narrative: Death on 05/04/2018 from unknown causes at this time. Vaccines given on 05/03/2018 in office.
Age: 72.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Asthenia, Fatigue, Insomnia, Muscle spasms, Myalgia
Clinical narrative: Leg cramps, fever (100 F), fatigue, muscle pain, weakness, right arm pain more than left one, trouble sleeping because of the pain and cramps. Took aspirin and ibuprofen after 3 hours.
Age: 72.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Leg cramps, fever (100 F), fatigue, muscle pain, weakness, right arm pain more than left one, trouble sleeping because of the pain and cramps. Took aspirin and ibuprofen after 3 hours.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Patient described warmth, redness and swelling at injection site. Also reported flu like symptoms felt as though she had the chills and was very tired.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Patient described warmth, redness and swelling at injection site. Also reported flu like symptoms felt as though she had the chills and was very tired.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injection site bruising, Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Patient was given Dose #1 of the Meningitis B/BEXSERO vaccine on Monday 4/23/2018. She developed a very large red, bruised and swollen area at the injection site the same day as she received the vaccine, and the symptoms became worse as the week progressed until Saturday. She went to the school nurse to show her the arm the following week, on Wednesday 5/2, and there had been some improvement by then. I spoke with her mother today and she stated she was also feeling a little under the weather for the week, but had no fever. She said as of today most of the swelling has resolved and she just has a little bump/nodule left at the site. I recommended her check with the primary doctor to see if she should get Dose #2, and to call us if there was any worsening of symptoms.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site rash, Lethargy, Nausea
Clinical narrative: Pt complains of nausea and lethargy beginning day after shot. Also developed rash and pain below site of injection. Patient was better by Monday.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling starting at injection site about 24 hours after admin. Redness and swelling spread around arm - severe by eval 4 days after admin. ? Cellulitis vs. allergic rxn vs. other ADR.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site bruising, Injection site pain, Pain
Clinical narrative: Chills, aches, and bruising/pain at injection site. These symptoms lasted for 2 days.
Sex: M
Vaccine: PPV
Symptoms: Tendon rupture
Clinical narrative: This spontaneous report was received from a male patient of unknown age referring to himself. The patient's pertinent medical history, drug reactions/allergies, concurrent conditions and concomitant medications were not reported. On an unspecified date in 2016 (reported as "about two years"), the patient was vaccinated with the second dose of PNEUMOVAX 23 0.5 ml, for prophylaxis (route of administration, lot # and expiration date were not reported). It was reported that 5 or 6 days later, the patient went to play golf and blew out two tendons (tendon rupture) in his shoulder. It was unknown if any treatment was given for the event or if any laboratory/diagnostic test was performed. At the time of reporting, the outcome of the event was unknown.  The causality assessment between the event and PNEUMOVAX 23 was not provided.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner via a company representative, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions or concomitant medication were not informed. On unknown dates, "before age 15", the patient was vaccinated two doses of GARDASIL 9 for prophylaxis (dosage information, lot number and route of administration were not informed), however the patient was unsure if the second dose was given 6-12 months after the initial dose. No adverse effect were reported in the patient.
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Deafness neurosensory, Deafness unilateral, Dysphagia, Herpes zoster
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 20-FEB-2014, the patient was inoculated with ZOSTAVAX from his primary care physician for routine health maintenance and for the prevention of shingles (route, dose, and lot # not provided). The vaccine did not prevent shingles, but rather caused the patient to contract a persistent and severe strain of herpes zoster. Shortly after receiving ZOSTAVAX (date not further specified), the patient was diagnosed with shingles inside his ears, which contributed to left ear hearing loss, pain and issues with balance. On 17-JUN-2016, the patient presented to an ear, nose, and throat/allergy physician with these complaints and was diagnosed as suffering from sudden left sensorineural hearing loss (also abbreviated by the lawyer as "SNHL"). Thereafter, on an unspecified date, the patient was hospitalized and was diagnosed as suffering from Ramsay Hunt Syndrome. At the time of the report (reported as "currently"), the patient continued to suffer from pronounced left ear hearing loss, sensitivity to sound, difficulty swallowing, and issues with balance. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The lawyer considered the events to be related to ZOSTAVAX. The events were not recovered at the time of reporting. Upon internal review, persistent and severe strain of herpes zoster/shingles inside the ears which contributed to left ear hearing loss, pain, and issues with balance/Ramsay Hunt Syndrome was considered medically significant. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster oticus, Hyperacusis, Pain, Sudden hearing loss, Vaccination failure
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On 20-FEB-2014, the patient was inoculated with ZOSTAVAX from his primary care physician for routine health maintenance and for the prevention of shingles (route, dose, and lot # not provided). The vaccine did not prevent shingles, but rather caused the patient to contract a persistent and severe strain of herpes zoster. Shortly after receiving ZOSTAVAX (date not further specified), the patient was diagnosed with shingles inside his ears, which contributed to left ear hearing loss, pain and issues with balance. On 17-JUN-2016, the patient presented to an ear, nose, and throat/allergy physician with these complaints and was diagnosed as suffering from sudden left sensorineural hearing loss (also abbreviated by the lawyer as "SNHL"). Thereafter, on an unspecified date, the patient was hospitalized and was diagnosed as suffering from Ramsay Hunt Syndrome. At the time of the report (reported as "currently"), the patient continued to suffer from pronounced left ear hearing loss, sensitivity to sound, difficulty swallowing, and issues with balance. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, he has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. The lawyer considered the events to be related to ZOSTAVAX. The events were not recovered at the time of reporting. Upon internal review, persistent and severe strain of herpes zoster/shingles inside the ears which contributed to left ear hearing loss, pain, and issues with balance/Ramsay Hunt Syndrome was considered medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Herpes zoster, Rash vesicular
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received concerning the patient's past medical history, concurrent conditions, or concomitant medication. During 2015, the patient was inoculated by a physician with ZOSTAVAX (lot number, dosage, and route of administration not provided), for routine adult health maintenance and the intended purpose for the prevention of shingles. The ZOSTAVAX vaccine did not prevent shingles as intended. The patient subsequently contracted a persistent strain of herpes zoster, the very virus the ZOSTAVAX is intended to prevent. During 2016, the patient was treated at the Health Center for a burning vesicular outbreak, which was diagnosed as herpes zoster, or shingles. As a direct and proximate result of the ZOSTAVAX vaccine, and/or despite receiving ZOSTAVAX for long term prevention of shingles, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: 27 weeks pregnant. Received Tdap vaccination. A few days later started with severe shoulder pain, decreased range of motion, and unable to put any pressure on that side.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Pruritus generalised, Rash generalised
Clinical narrative: Mom contacted clinic by telephone and stated patient c/o itching all over and she noticed rash to body. Mom was instructed to take patient to ER and voiced understanding. This clinic follow up with mom and she stated she called 911 and EMT(s) came to home and administered BENADRYL. Mom stated itching stopped and rash was better. Patient was scheduled an appointment with Dr. on 5/9/2018 for rash to body and to rule / rule out adverse reaction.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Fatigue, Feeling abnormal, Headache
Clinical narrative: Cold and shivering, headache, body ache, distant feeling in my head, weak, fatigued.
Age: 52.0
Sex: M
Vaccine: VARZOS
Symptoms: Nasopharyngitis, Pain
Clinical narrative: Cold and shivering, headache, body ache, distant feeling in my head, weak, fatigued.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Diarrhoea, Ear pain, Erythema, Hypoaesthesia
Clinical narrative: Patient stated that on 5-5-18 she experienced swelling and a bruise. On 5-6-18 she experienced redness, itching, diarrhea, and an earache. On 5-7-18 symptoms seemed to intensify and in the evening she experienced numbness/tingling/tightness in arm to elbow so she went to the ER.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscle tightness, Paraesthesia, Pruritus, Swelling
Clinical narrative: Patient stated that on 5-5-18 she experienced swelling and a bruise. On 5-6-18 she experienced redness, itching, diarrhea, and an earache. On 5-7-18 symptoms seemed to intensify and in the evening she experienced numbness/tingling/tightness in arm to elbow so she went to the ER.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Injection site reaction, Rash vesicular
Clinical narrative: Vesicular rash in clusters on left upper arm in area where MENACTRA and TRUMENBA vaccines were administered on 05/04/2018. Differential might be herpetic rash, skin reaction to secondary to immunizations, pohtodermatitis.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site rash, Injection site warmth
Clinical narrative: Patient came back to the pharmacy on 05/08/2018 showing the pharmacist her rash at the site of the injection. The rash was about 1.5 inch wide and 4 inches long down toward the elbow. It was firm and warm to touch. Patient stated that she started notice that the same night she got the shot. She tried to put some ice on but it didn't help. Other than that, patient didn't report any other problem.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Confluent spreading erythema and edema over left deltoid and upper arm measuring approximately 6 inches in diameter progressing over a few days. Patient was given IM injection of 125 mg SOLU-MEDROL 800mg/160mg Suflamethoxazole/Trimethoprim BID x 7 days.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient had redness, swelling, and warmth around injection site. She had the vaccination on 04/25/2018. Reported the adverse reaction on 05/02/2018 and was instructed to use BENADRYL for the reaction. Followed up with patient on 05/08/2018 and symptoms had resolved after a few doses of the BENADRYL.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose increased, Fatigue, Headache, Injection site pain, Insomnia
Clinical narrative: In about six hours after injection, strong pain at injection site. Very tender. At evening time, achiness started and difficult to sleep with pain in arm radiating from injection site. By morning of next day, serious general muscle aches over entire body. Strong headache emanating from back of head and neck out to shoulders. General tiredness and muscle weakness. Unable to perform day's activities. Blood sugar spiked throughout day, even without eating. (Most likely from cortisol being stimulated from oxidative stress of strong muscle ache). Adverse events started to taper off morning of second day. Took 4- 80 mg aspirin which cleared up headache by nightfall. By evening of second day, felt normal.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Loss of personal independence in daily activities, Muscular weakness, Myalgia, Pain, Pain in extremity
Clinical narrative: In about six hours after injection, strong pain at injection site. Very tender. At evening time, achiness started and difficult to sleep with pain in arm radiating from injection site. By morning of next day, serious general muscle aches over entire body. Strong headache emanating from back of head and neck out to shoulders. General tiredness and muscle weakness. Unable to perform day's activities. Blood sugar spiked throughout day, even without eating. (Most likely from cortisol being stimulated from oxidative stress of strong muscle ache). Adverse events started to taper off morning of second day. Took 4- 80 mg aspirin which cleared up headache by nightfall. By evening of second day, felt normal.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Flushing, Hot flush, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient experienced nausea; hot and cold flashes; had a red, swollen and hard arm at injection site. MD office directed to take 2 extra strength TYLENOL.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Nausea
Clinical narrative: Patient experienced nausea; hot and cold flashes; had a red, swollen and hard arm at injection site. MD office directed to take 2 extra strength TYLENOL.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Gastrointestinal pain, Headache, Peripheral swelling
Clinical narrative: Very red, swollen arm, headache, fatigue, upper GI pain.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: PATIENT RECEVIED THE VACCINE ON 5/2/18. PATIENT STARTED TO HAVE NORMAL RASH AROUND THE NECK AND BELOW THE BREAST ON SUNDAY, 5/6/18. ADVISED PATIENT TO GO SEE HER PRIMARY CARE DOCTOR OR URGENT CARE RIGHT AWAY. PATIENT STATED SHE WILL BE SEEING HER DOCTOR ON FRIDAY 5/11/18.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Patient called regarding a different issue, then states she had a reaction to the PREVNAR 13 vaccination of redness and swelling from her shoulder down to her hand of the Left arm/forearm. States it has since resolved. Pt was given vaccination on 5/2/18 and I spoke with pt on 5/8/18, which is when she informed me of the adverse reaction. The vaccination was added to her allergies/rxn list, provider was notified. The vaccination adverse reaction is currently being reported.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site erythema, Injection site pain
Clinical narrative: Nausea, fatigue-exhaustion, headache, chills, stuffed nose, muscle aches, sore at site but not very red.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Nasal congestion, Nausea
Clinical narrative: Nausea, fatigue-exhaustion, headache, chills, stuffed nose, muscle aches, sore at site but not very red.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Swelling, redness, pain. increased over 1 day.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: Large pink egg sized swelling in the area of injection. Patient informed to apply a cold compress to area and take TYLENOL for pain.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Hypoaesthesia, Injection site erythema, Injection site paraesthesia, Injection site swelling, Injection site warmth
Clinical narrative: 5/4 - increased upper arm swelling at injection site. 5/5 - increased upper arm swelling/redness/warmth/tingling right hand. 5/6 - increased pain, tingling/numbness both hands right  greater than left. 5/8 - improving symptoms. Seen in office - normal exam, minimal swelling noted right deltoid. Normal cervical xray.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain in extremity, Paraesthesia, Spinal X-ray normal
Clinical narrative: 5/4 - increased upper arm swelling at injection site. 5/5 - increased upper arm swelling/redness/warmth/tingling right hand. 5/6 - increased pain, tingling/numbness both hands right  greater than left. 5/8 - improving symptoms. Seen in office - normal exam, minimal swelling noted right deltoid. Normal cervical xray.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Pain in extremity, Presyncope
Clinical narrative: PAIN IN ALL FINGER JOINTS AND DIZZINESS. PATIENT ALMOST FAINTED AND ENDED UP IN THE ER. STILL IN PAIN 4 DAYS LATER.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Hyperhidrosis, Myalgia, Pain in extremity
Clinical narrative: Patient states that all of his joints hurt, muscles hurt, shivering, sweating, fever of 102 degrees, and his arm was very sore. He has had shingles before, and states that the feeling was "just like I had shingles again". Patient was advised to seek medical treatment if symptoms persisted or became worse. This patient could barely go to the medicine cabinet to see if he had some naproxen.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient states that all of his joints hurt, muscles hurt, shivering, sweating, fever of 102 degrees, and his arm was very sore. He has had shingles before, and states that the feeling was "just like I had shingles again". Patient was advised to seek medical treatment if symptoms persisted or became worse. This patient could barely go to the medicine cabinet to see if he had some naproxen.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Dyspnoea, Fatigue, Myalgia, Pain in extremity
Clinical narrative: Patient received vaccine at pharmacy, but talked to me about his reaction here at another pharmacy. So, I don't have access to all info (including Lot # or expiration). The patient stated that his arm was sore for 3 days after the vaccine, which is typical. But, then he said he was fine for 3-4 days before muscle aches, shortness of breath, and fatigue began. He also stated that he started metformin at the same time as the vaccine. He has continued metformin for 6 weeks. I told the patient that I would submit the VAERS form--just in case, but it is very possible that these effects are the result of the metformin. The patient was instructed to inform his prescriber about this reaction, and he assured me he would contact his doctor.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient states had 3 days of fever, at times as high as 104, finally better after 3 days. Patient took OTC acetaminophen.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Asthenia, Decreased appetite, Dizziness, Headache, Malaise
Clinical narrative: Patient states had 3 days of fever, at times as high as 104, finally better after 3 days. Patient took OTC acetaminophen.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Patient states had 3 days of fever, at times as high as 104, finally better after 3 days. Patient took OTC acetaminophen.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: PATIENT REPORTED SIGNIFICANT SWELLING (DESCRIBED AS 1/2 A BASEBALL SIZE) AT INJECTION SITE, BRIGHT RED, SORE AND ACHY AT INJECTION SITE. ALSO ACHY JOINTS AND MUSCLE FOR 2-3 DAYS FOLLOWING THE VACCINATION.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Facial pain, Toothache, Trigeminal neuralgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of trigeminal neuralgia in a male patient who received SHINGRIX. On 25th April 2018, the patient received the 1st dose of SHINGRIX. In  April 2018, less than a week after receiving SHINGRIX, the patient experienced trigeminal neuralgia, facial pain and toothache. On an unknown date, the outcome of the trigeminal neuralgia, facial pain and toothache were unknown. It was unknown if the reporter considered the trigeminal neuralgia, facial pain and toothache to be related to SHINGRIX. Additional details were provide as follows: The age at the vaccination was not reported. The patient was experiencing facial pain like a bad toothache on his left side of face, like trigeminal neuralgia and it was very painful.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Endodontic procedure, Eye swelling, Orthosis user, Pain in jaw
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of trigeminal neuralgia in a male patient who received SHINGRIX. On 25th April 2018, the patient received the 1st dose of SHINGRIX. In  April 2018, less than a week after receiving SHINGRIX, the patient experienced trigeminal neuralgia, facial pain and toothache. On an unknown date, the outcome of the trigeminal neuralgia, facial pain and toothache were unknown. It was unknown if the reporter considered the trigeminal neuralgia, facial pain and toothache to be related to SHINGRIX. Additional details were provide as follows: The age at the vaccination was not reported. The patient was experiencing facial pain like a bad toothache on his left side of face, like trigeminal neuralgia and it was very painful.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Toothache, X-ray dental abnormal
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of trigeminal neuralgia in a male patient who received SHINGRIX. On 25th April 2018, the patient received the 1st dose of SHINGRIX. In  April 2018, less than a week after receiving SHINGRIX, the patient experienced trigeminal neuralgia, facial pain and toothache. On an unknown date, the outcome of the trigeminal neuralgia, facial pain and toothache were unknown. It was unknown if the reporter considered the trigeminal neuralgia, facial pain and toothache to be related to SHINGRIX. Additional details were provide as follows: The age at the vaccination was not reported. The patient was experiencing facial pain like a bad toothache on his left side of face, like trigeminal neuralgia and it was very painful.
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Endodontic procedure, Pain in jaw, Pulpitis dental
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of trigeminal neuralgia in a male patient who received SHINGRIX. On 25th April 2018, the patient received the 1st dose of SHINGRIX. In  April 2018, less than a week after receiving SHINGRIX, the patient experienced trigeminal neuralgia, facial pain and toothache. On an unknown date, the outcome of the trigeminal neuralgia, facial pain and toothache were unknown. It was unknown if the reporter considered the trigeminal neuralgia, facial pain and toothache to be related to SHINGRIX. Additional details were provide as follows: The age at the vaccination was not reported. The patient was experiencing facial pain like a bad toothache on his left side of face, like trigeminal neuralgia and it was very painful.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 75-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 30th April 2019). Previously administered products included ZOSTAVAX (received in 2017). On 23rd April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 24th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling and injection site itching. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site itching were not recovered/not resolved. The reporter considered the injection site pain, injection site erythema, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient reported that the day after she was vaccinated with SHINGRIX on left arm, she experienced injection site soreness. The patient took BENADRYL and it helped but she called the pharmacy today and stated that the redness comes and goes and the area was itching. The patient was concerned that ZOSTAVAX vaccine could be related to her symptoms.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site discolouration, Injection site erythema, Injection site hypersensitivity, Injection site pain
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 75-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 30th April 2019). Previously administered products included ZOSTAVAX (received in 2017). On 23rd April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 24th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling and injection site itching. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site itching were not recovered/not resolved. The reporter considered the injection site pain, injection site erythema, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient reported that the day after she was vaccinated with SHINGRIX on left arm, she experienced injection site soreness. The patient took BENADRYL and it helped but she called the pharmacy today and stated that the redness comes and goes and the area was itching. The patient was concerned that ZOSTAVAX vaccine could be related to her symptoms.
Age: 75.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: This case was reported by a pharmacist and described the occurrence of injection site pain in a 75-year-old female patient who received SHINGRIX (batch number HG4P3, expiry date 30th April 2019). Previously administered products included ZOSTAVAX (received in 2017). On 23rd April 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 24th April 2018, 1 days after receiving SHINGRIX, the patient experienced injection site pain, injection site erythema, injection site swelling and injection site itching. The patient was treated with BENADRYL. On an unknown date, the outcome of the injection site pain, injection site erythema, injection site swelling and injection site itching were not recovered/not resolved. The reporter considered the injection site pain, injection site erythema, injection site swelling and injection site itching to be related to SHINGRIX. Additional details were provided as follows: The patient reported that the day after she was vaccinated with SHINGRIX on left arm, she experienced injection site soreness. The patient took BENADRYL and it helped but she called the pharmacy today and stated that the redness comes and goes and the area was itching. The patient was concerned that ZOSTAVAX vaccine could be related to her symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of shingles in a female patient who received SHINGRIX. 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 reporter had a patient who experienced shingles shortly after vaccination. The reporter attempted to research if she should still get the 2nd dose of the vaccine and if so at what point but was unable to locate any pertinent information regarding this. The reporter was asking for this information. No additional information was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a elderly male patient who received SHINGRIX. Concomitant products included allopurinol, CRESTOR, FLOMAX, Levothyroxine, Losartan, Vitamin B12, Vitamin D3 and TYLENOL. In March 2018, the patient received the 1st dose of SHINGRIX .5 ml. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced injection site erythema, injection site swelling and injection site induration. The patient was treated with Cortisone Topical Cream. On an unknown date, the outcome of the injection site erythema, injection site swelling and injection site induration were recovered/resolved. The reporter considered the injection site erythema, injection site swelling and injection site induration to be related to SHINGRIX. Additional details were provided as follows: The reporter was wife of the patient. In end of March 2018, the patient received dose of SHINGRIX in right arm. The patient developed a large red and hard swollen area on his upper arm around the injection site. Caller reported that she applied cortisone cream to the area and that after 5 days the events were resolved.