chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Somnolence
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 70-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included splenectomy. Concurrent medical conditions included thyroid disorder, diabetes, cirrhosis of liver without mention of alcohol and idiopathic thrombocytopenic purpura. Concomitant products included thyroxine sodium (Levothyroxine). In December 2018, the patient received the 1st dose of SHINGRIX (intramuscular). In December 2018, 3 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site erythema, injection site warmth and injection site pain. On an unknown date, the patient experienced fatigue and daytime sleepiness. The patient was treated with acetylsalicylic acid (Aspirin). On an unknown date, the outcome of the extensive swelling of vaccinated limb was recovering/resolving and the outcome of the injection site erythema and injection site warmth were recovered/resolved and the outcome of the fatigue and daytime sleepiness were unknown and the outcome of the injection site pain was not recovered/not resolved. It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site erythema, injection site warmth, fatigue, injection site pain and daytime sleepiness to be related to SHINGRIX. Additional details were provided as follows: About 3 days after receiving the vaccine the site around the injection site was swollen, red and hot covering area of 7 inches by 7 inches. The events red and hot were not anymore, but the area was still little bit swollen. The patient tried putting ice and taken aspirin to help with the pain. The patient did not know the full form of ITP. Accidentally hit one when they asked patient how much time it took to get it. The patient called yesterday and was put on a list and they will been going to call her back and the phone probably was dead, but she waited they know, she did not know, three or four minutes and then went on the call list. Today, when the patient talked to a representative, she was surprised that they called her or answered the phone, (inaudible) on the other end, that was excellent. As far as referring people to their company, it was depending on what the doctor prescribes for her and she trust on her doctor. However, the patient had a reaction and still in a lot of pain in her left arm, it was being almost a month and they can read the report where it was swollen. But as far as the representative, they were great, courteous, and just, you know, directed patient through, so she could not had asked for a better person to do that No further details were provided at time of reporting.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Pain in extremity
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in arm in a 68-year-old male patient who received SHINGRIX (batch number 9KT7T, expiry date unknown) for prophylaxis. Previously administered products included SHINGRIX (1st dose received on 31st May 2018). On 8th December 2018, the patient received the 2nd dose of SHINGRIX. On 8th December 2018, unknown after receiving SHINGRIX, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the drug dose administration interval too long was unknown. It was unknown if the reporter considered the pain in arm to be related to SHINGRIX. Additional details were provided as follows: The health care professional reported the patient received 2nd dose of SHINGRIX. Less than a month after injection, the arm pain was developed for several weeks. At this time of reporting, the pain was still ongoing.  No further details were reported regarding the event. The health care professional stated that the vaccine was administered at a different facility. No further details of facility location available at the time of report. The reporter gave consent to follow up.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Musculoskeletal pain, Nuclear magnetic resonance imaging, Pain, 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 65-year-old male patient who received SHINGRIX for prophylaxis. The patient's past medical history included shoulder injury (in 1993) and stroke (hospitalization in 2017). On 1st October 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On an unknown date, less than a year after receiving SHINGRIX, the patient experienced pain in arm and shoulder pain. The patient was treated with cortisone (non-proprietary) (Cortisone Injection). On an unknown date, the outcome of the pain in arm and shoulder pain were not recovered/not resolved. It was unknown if the reporter considered the pain in arm and shoulder pain to be related to SHINGRIX. Additional information was reported as follows: The patient received SHINGRIX on the left arm. After vaccination, the patient experienced left shoulder and left upper arm pain that had gotten progressively worse. At the time of reporting, the pain occurred anytime the patient stretched out his left arm and manifests as pain in the shoulder area. The patient had seen a physician about this. The patient had an nuclear magnetic resonance imaging (MRI) and treated with cortisone injection, physical therapy and oral medication for pain. The contact details of the physician was provided. The reporter was consented to follow up.  Lab Comments: On an unknown date, the patient had nuclear magnetic resonance imaging (MRI).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Inappropriate schedule of product administration, Pyrexia, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of chills in a 59-year-old female patient who received SHINGRIX for prophylaxis. Previously administered products included SHINGRIX with an associated reaction of injection site pain (1st dose received on 6th June 2018, refer case US2018103117 for 1st dose). On 31st December 2018, the patient received the 2nd dose of SHINGRIX (intramuscular). On 31st December 2018, less than a day after receiving SHINGRIX, the patient experienced chills, fever and tremor. On an unknown date, the outcome of the chills, fever and tremor were recovered/resolved. It was unknown if the reporter considered the chills, fever and tremor to be related to SHINGRIX. Additional information was reported as follows: The patient received SHINGRIX on the left arm. The patient received their 2nd dose of SHINGRIX which was later the recommended schedule, which led to lengthening of the vaccination schedule. After vaccination, the patient experienced chills, fever and shaky. The reporter gave consented to follow up.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Headache
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of ear pain in a 72-year-old female patient who received SHINGRIX for prophylaxis. On 5th January 2019, the patient received the 1st dose of SHINGRIX (intramuscular). In January 2019, less than a week after receiving SHINGRIX, the patient experienced ear pain and headache. In January 2019, the outcome of the ear pain and headache were recovered/resolved. It was unknown if the reporter considered the ear pain and headache to be related to SHINGRIX. Additional details were provided as follows: The patient received dose of SHINGRIX in the left arm. In January 2019, the patient experienced an earache in her left ear and a headache after the SHINGRIX injection and that both issues had resolved. The patient did not consent to follow-up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood pressure systolic increased, Dizziness, Feeling of body temperature change, Immediate post-injection reaction
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of lightheadedness in a 74-year-old female patient who received SHINGRIX for prophylaxis. The patient's past medical history included leukemia and low blood pressure. Previously administered products included SHINGRIX (did not mention any adverse event). On 7th January 2019, the patient received the 2nd dose of SHINGRIX (intramuscular) .5 ml. On 7th January 2019, immediately after receiving SHINGRIX, the patient experienced lightheadedness, blood pressure systolic increased and feeling hot and cold. On an unknown date, the outcome of the lightheadedness, blood pressure systolic increased and feeling hot and cold were recovering/resolving. It was unknown if the reporter considered the lightheadedness, blood pressure systolic increased and feeling hot and cold to be related to SHINGRIX. Additional details were reported as follows: The patient received SHINGRIX on the left arm at a pharmacy. Immediately after the injection, the patient felt faint and lightheaded. The patient also felt hot and then cold intermittently. The patient could not drive for home and an ambulance was called. The patient was taken to the hospital emergency department. She stayed for 3 hours, was monitored and went for home. The patient also experienced a high systolic reading of 148 and at discharge, it dropped to 110. At the time of reporting, the events were improved. The reporter did not consent to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes simplex
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of herpes simplex in a 60-year-old male patient who received SHINGRIX for prophylaxis. On 29th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On 30th August 2018, 1 days after receiving SHINGRIX, the patient experienced herpes simplex. The patient was treated with valaciclovir hydrochloride (Valtrex). In September 2018, the outcome of the herpes simplex was recovered/resolved. It was unknown if the reporter considered the herpes simplex to be related to SHINGRIX. Additional details were provided as follows: The patient received the dose of SHINGRIX vaccine on the left arm. The next day after the SHINGRIX vaccine, the patient broke out with herpes simplex virus 2 on his buttocks. The patient took Valtrex and this lasted for about a week. The patient did not have to go see his physician, he had Valtrex so he just took them. The patient consented to follow up. The patient had provided contact details of his physician. No further details were provided.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Axillary pain, Lymphadenopathy, Pyrexia
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of fever in a 59-year-old male patient who received SHINGRIX (batch number 77PL3, expiry date 18th April 2021) for prophylaxis. On 13th December 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On an unknown date, less than a month after receiving SHINGRIX, the patient experienced fever, axillary pain and axillary lymph nodes enlarged. On an unknown date, the outcome of the fever, axillary pain and axillary lymph nodes enlarged were recovered/resolved. It was unknown if the reporter considered the fever, axillary pain and axillary lymph nodes enlarged to be related to SHINGRIX. Additional details were reported as follows: After receiving SHINGRIX the patient had a fever for about 3 hours. Within 24 hours of his fever resolving he developed soreness and a swollen lymph node in his armpit. This lasted for about 3 days.
Sex: U
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of hives 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 hives. On an unknown date, the outcome of the hives was unknown. It was unknown if the reporter considered the hives to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The caller reported that her pharmacist told her that another one of their patients had hives after getting SHINGRIX.
Sex: F
Vaccine: FLUC4
Symptoms: Foetal exposure during pregnancy, Low birth weight baby
Clinical narrative: This is a serious spontaneous case, initially received from a physician on 19-Oct-2018, concerning a female infant patient of unspecified age. The mother was a 31-year-old female, whose historical drug included Metrogel for vaginitis and historical condition included multigravida, two spontaneous abortions and 4 full term live births. The concomitant medications included Ferrous sulfate for anemia and Prenatal vitamins [minerals nos, vitamins nos] for pregnancy. The estimated delivery date (EDD) was 12-Jan-2019. The pregnancy was without complications. At approximately 28 weeks gestation, on 19-Oct-2018, the patient's mother received FLUCELVAX QIVc vaccine [influenza vaccine, subunit influenza virus vaccine polyvalent, cell-culture derived, batch number: 252664, dose, route of administration, expiry date and anatomical location: not reported) (explicitly coded as fetal exposure during pregnancy) for an unknown indication. On an unspecified date, the mother developed hypertension, pericardial effusion, anemia, diagnostic ultrasound abnormal (Echogenic foci) and vaginitis. On 26-Dec-2018, the mother vaginally delivered a full term female infant at 37.6 weeks gestation. The infant's birth weight was 2155 grams, her length was 45.7 cm and head circumference was 30.5 cm. The APGAR scores were 8 (one minute) and 9 (five minutes). The infant had low weight at birth and was observed in the normal nursery. The outcome of the event was not reported. This case is linked to (201900313), the corresponding maternal pregnancy report.; Reporter's Comments: A female infant had a full term delivery with low birth weight (2155 gms), after FLUCELVAX QIVc vaccine exposure during pregnancy. The maternal history during pregnancy included hypertension and anaemia. The event low birth weight can be attributed to maternal history (hypertension, anaemia) rather than suspect vaccine. Hence, causality of the event low birth weight was assessed as not related to suspect vaccine. The company assessed the event (low birth weight baby) as serious (medically significant).
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Pruritus, Skin warm, Urticaria
Clinical narrative: Redness, warmth, hives, itching to trunk and abdomen.
Age: 35.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Arteriosclerosis, Catheterisation cardiac abnormal, Chest discomfort, Chest pain, Coronary artery dissection
Clinical narrative: Chest pain post SPV- pos enzymes, post EKG. No robust take. Vaccinated 24 Apr. 06 May awoke with pressure in center of chest. No rad, no SOB, diaphoresis, dizziness or palpitations. Never had pain like this before. Went to ED. Transferred underwent heart cath. Results below. Symptoms: CHEST PAIN, UNSPECIFIED(R079).
Age: 35.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Coronary artery occlusion, Electrocardiogram ST segment elevation, Nuclear magnetic resonance imaging abnormal, Nuclear magnetic resonance imaging heart, Troponin T increased
Clinical narrative: Chest pain post SPV- pos enzymes, post EKG. No robust take. Vaccinated 24 Apr. 06 May awoke with pressure in center of chest. No rad, no SOB, diaphoresis, dizziness or palpitations. Never had pain like this before. Went to ED. Transferred underwent heart cath. Results below. Symptoms: CHEST PAIN, UNSPECIFIED(R079).
Age: 26.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Dysphagia, Muscle tightness
Clinical narrative: Employee received first dose of MMR vaccine and Varicella vaccine based on negative titer results. After waiting in the office for a period of time the RN asked if he felt fine to leave and he stated yes. About 30 minutes after he left, he called and said he felt tightness in his back and it was hard to swallow. The nurse directed him straight to the Emergency Department. Employee stated he was treated with an EPIPEN and given oral ZYRTEC and Prednisone.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Lethargy, Malaise
Clinical narrative: Zoster recombinant sub-unit 2 dose (IM) - this is what was listed on my medical record regarding the 2nd dose. Starting around 7:00 p.m. on 1/6/19 I started feeling unwell. Tired, dragging, not 100%. Went to bed at 10:00 p.m. and at around 11:00 p.m. I got severe chills - that lasted a few hours. I took a MOTRIN after an hour and it took awhile to help. I was fine for awhile and then I got the sweats real bad - then that subsided. Felt fine when I woke up in the morning. Around 8:30 the chills returned but not as severe - I went to work and just kept my coat on. When I received the vaccine the first time on 6/13/2018 I did not experience chills but felt unwell and tired for almost 2 weeks. I am a healthy individual and have never experienced side effects from any shot or immunization.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Body temperature increased
Clinical narrative: Woke at 12:00 am with axillary temp of 100.9. No swelling, redness or site soreness.
Age: 61.0
Sex: F
Vaccine: FLUC4
Symptoms: Chills, Fatigue, Influenza like illness, Myalgia
Clinical narrative: Complaining of chills, fatigue and muscle aches and "flu-like" symptoms.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In January 2017, a physician administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In January 2017, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. In 2007, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. In March 2017, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient (age unknown). The patient's medical history, concurrent conditions and concomitant medication use were not provided. The patient's healthcare provider recommended, and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 15-MAR-2013, a healthcare provider administered ZOSTAVAX, (lot# and route unknown) to the patient. The patient was inoculated with the ZOSTAVAX vaccine to obtain permanent prevention and protection against shingles and zoster-related injuries. On or about September 2013, the patient was treated by a healthcare provider for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. The patient used the ZOSTAVAX vaccine for the permanent prevention of shingles and zoster-related injuries. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare providers recommended and/or prescribed ZOSTAVAX to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related injuries. In 2007, a physician administered the ZOSTAVAX to the patient (lot number, dosage and route of administration not provided). In 2009, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 26-NOV-2018, the patient was administered an improperly stored dose of PROQUAD rHA lot number R017802 with expiration date of 19-DEC-2019 and lot number R020815 with expiration date of 16-JAN-2020 and VARIVAX lot number R019237 with expiration date of 04-JUL-2020, lot number R022116 with expiration date of 02-AUG-2020 and lot number N023963 with expiration date of 01-SEP-2019, subcutaneously for prophylaxis (dose, anatomical location, lot number and expiration date were not reported). No adverse effects were reported. The vaccines were exposed to a temperature excursions of 6°F to 14°F for 30 Minutes and 15°F to 46°F for 1 hour and 20 minutes while the sterile water diluent did not undergo a temperature excursion. Previous temperature excursions were reported as follows: VARIVAX: Lot number R019237: 6°F to 14°F 30 min, 15°F to 46°F 12 hours 45 minutes. Lot number R022116: 15°F to 46°F 6 hours 45 minutes. Lot number N023963: 15°F to 46°F 7 hours 45 minutes. PROQUAD: Lot number R020815: 15°F to 46°F 7 hours 45 minutes. Lot number R017802: 15°F to 46°F 9 hours 45 minutes. A "data logger" was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1901USA006165.
Sex: M
Vaccine: VARZOS
Symptoms: Neuralgia
Clinical narrative: This initial spontaneous report was received on 15-JAN-2019 from a 75 year old male patient referring to himself. The patient wished to remain anonymous and did not wish to provide any information regarding medical history, concurrent conditions, or concomitant medications. In approximately 2007 (reported as 12 years ago), the patient received ZOSTAVAX (dose, route, and lot # not reported. He stated that he is still suffering from unspecified nerve pain associated with the receipt of the vaccination. (onset date of the nerve pain not specified). The nerve pain has continuously been treated with gabapentin. The patient's present status was not recovered.  Causality assessment was related. The patient mentioned that he had retained or was in the process of retaining a lawyer to issue a lawsuit against the Company for the adverse effects he sustained following vaccination with ZOSTAVAX.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. No information was provided regarding the patient's medical history, concurrent conditions, drug reactions or allergies and concomitant medication. On 26-NOV-2018, the patient was administered an improperly stored dose of vaccinated PROQUAD, rHA lot number R017802 with expiration date of 19-DEC-2019 and lot number R020815 with expiration date of 16-JAN-2020 and VARIVAX, lot number R019237 with expiration date of 04-JUL-2020, lot number R022116 with expiration date of 02-AUG-2020 and lot number N023963 with expiration date of 01-SEP-2019, subcutaneously for prophylaxis (dose, anatomical location, lot number and expiration date were not reported). No adverse effects were reported. The vaccines were exposed to a temperature excursions of 6 degrees F to 14 degrees F for 30 Minutes and 15 degrees F to 46 degrees F for 1 hour and 20 minutes while the sterile water diluent did not undergo a temperature excursion. Previous temperature excursions were reported as follows: VARIVAX: Lot number R019237: 6 degrees F to 14 degrees F 30 min, 15 degrees F to 46 degrees F 12 hours 45 minutes; Lot number R022116: 15 degrees F to 46 degrees F 6 hours 45 minutes; Lot number N023963: 15 degrees F to 46 degrees F 7 hours 45 minutes. PROQUAD: Lot number R020815: 15 degrees F to 46 degrees F 7 hours 45 minutes; Lot number R017802: 15 degrees F to 46 degrees F 9 hours 45 minutes. A "data logger" was involved. This is one of two reports received from the same reporter. Sender's Comments: US-009507513-1901USA005088.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Disability, Fatigue, Headache, Injection site pain
Clinical narrative: Disabilitating joint pain, headache, fever, fatigue, severe pain at shot site. This while being under pain management with oxycodone.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain management, Pyrexia
Clinical narrative: Disabilitating joint pain, headache, fever, fatigue, severe pain at shot site. This while being under pain management with oxycodone.
Age: 68.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Hypersomnia, Malaise, Pyrexia
Clinical narrative: Sick for 5 days, slept 18 hours a day for 3 days, 101 fever.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Cellulitis at site of injection, redness, swelling, warmth. Spreading of redness. Was seen on 11/21/18 for assessment of problem. Put on KEFLEX and problem resolved.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea, Retching
Clinical narrative: I woke up at 5:30am with shaking chills, then got nauseated and had the dry heaves, as well as headache & tiredness. It is now 11:30am and I feel better, but still have occasional queasiness, slight headache and still somewhat tired, but overall better.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: I woke up at 5:30am with shaking chills, then got nauseated and had the dry heaves, as well as headache & tiredness. It is now 11:30am and I feel better, but still have occasional queasiness, slight headache and still somewhat tired, but overall better.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Confusional state, Fatigue, Headache
Clinical narrative: Within 2 hrs---Blinding headache, confusion. At 12 hrs---Blinding headache, extreme confusion, fatigue. At 24 hrs---chills, Blinding headache, extreme confusion, fatigue, bone aches-wrist and ankle. Left work early because of symptoms, unable to perform any activities other than complete bedrest. Blinding headache not relieved by 800mg ibu. Difficultly falling asleep. Woke up in 4 hrs when 800mg ibu wore off and need another dose. At 36 hrs---headache present (but improved from previous), extreme fatigue. Experienced similar with first dose (7/2018) but onset of symptoms was swifter with 2nd dose.  1st dose fatigue did not resolve for 21 days.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Impaired work ability, Initial insomnia, Loss of personal independence in daily activities
Clinical narrative: Within 2 hrs---Blinding headache, confusion. At 12 hrs---Blinding headache, extreme confusion, fatigue. At 24 hrs---chills, Blinding headache, extreme confusion, fatigue, bone aches-wrist and ankle. Left work early because of symptoms, unable to perform any activities other than complete bedrest. Blinding headache not relieved by 800mg ibu. Difficultly falling asleep. Woke up in 4 hrs when 800mg ibu wore off and need another dose. At 36 hrs---headache present (but improved from previous), extreme fatigue. Experienced similar with first dose (7/2018) but onset of symptoms was swifter with 2nd dose.  1st dose fatigue did not resolve for 21 days.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Chills, Confusional state, Fatigue, Headache
Clinical narrative: Within 2 hrs---Blinding headache, confusion. At 12 hrs---Blinding headache, extreme confusion, fatigue. At 24 hrs---chills alternating with sweating, Blinding headache, extreme confusion, fatigue, bone aches-wrist and ankle. Left work early because of symptoms, unable to perform any activities other than complete bedrest. Blinding headache not relieved by 800mg ibu. Difficultly falling asleep. Woke up in 4 hrs when 800mg ibu wore off and need another dose. At 36 hrs---headache present (but improved from previous), extreme fatigue. ***Experienced similar with first dose (7/2018) but onset of symptoms was swifter with 2nd dose. 1st dose fatigue did not resolve for 21 days.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperhidrosis, Impaired work ability, Insomnia, Loss of personal independence in daily activities
Clinical narrative: Within 2 hrs---Blinding headache, confusion. At 12 hrs---Blinding headache, extreme confusion, fatigue. At 24 hrs---chills alternating with sweating, Blinding headache, extreme confusion, fatigue, bone aches-wrist and ankle. Left work early because of symptoms, unable to perform any activities other than complete bedrest. Blinding headache not relieved by 800mg ibu. Difficultly falling asleep. Woke up in 4 hrs when 800mg ibu wore off and need another dose. At 36 hrs---headache present (but improved from previous), extreme fatigue. ***Experienced similar with first dose (7/2018) but onset of symptoms was swifter with 2nd dose. 1st dose fatigue did not resolve for 21 days.
Age: 26.0
Sex: M
Vaccine: FLU4, HEPA, TDAP, TYP
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: I had two shots in each arm as outlined in Item 17. I had normal soreness in both arms during the 3 days following the vaccines. However, my left shoulder has since had significant pain and limited range of motion. I got the shots on Dec 13, 2018 and a couple of weeks later, while traveling abroad, contacted my Doctor about the pain. I tried heat/ice, ibuprofen, light exercise, but nothing has healed it or brought relief. As I sit here over a month later, the pain is still significant and has an effect on my daily life. I struggle to do basic tasks: get dressed in the morning, drive, grab food from the shelf, carry medium/large boxes, etc.
Age: 26.0
Sex: F
Vaccine: YF
Symptoms: Immediate post-injection reaction, Immune system disorder, Inflammation, Influenza, Malaise
Clinical narrative: INFLAMMATION OF ARMPIT GANGLIONS (INMEDIATELY AFTER THE SHOT). PAINFUL, COULD NOT LIFT MY ARMS. FEELING CONSTANLTY SICK (GOT THE FLU, INFECTED TONSILS WITHIN 2 MONTHS OF THE SHOT). Weak immune defenses. Ganglions in armpits and inguen are swollen still (stressed lymphatic system). No specific treatment. Trying to strengthen immune system.
Age: 26.0
Sex: F
Vaccine: YF
Symptoms: Mobility decreased, Pain in extremity, Swelling, Tonsillitis
Clinical narrative: INFLAMMATION OF ARMPIT GANGLIONS (INMEDIATELY AFTER THE SHOT). PAINFUL, COULD NOT LIFT MY ARMS. FEELING CONSTANLTY SICK (GOT THE FLU, INFECTED TONSILS WITHIN 2 MONTHS OF THE SHOT). Weak immune defenses. Ganglions in armpits and inguen are swollen still (stressed lymphatic system). No specific treatment. Trying to strengthen immune system.
Age: 1.33
Sex: M
Vaccine: FLUX
Symptoms: Extra dose administered, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Severe swelling at the injection site. The size of a softball that encompassed his entire left thigh. Raised, red, hot to the touch. It went away after 2 days. I don't know what type of flu vaccine it was but he had received one 2 months prior that was not recorded so this was an unnecessary 2nd vaccination for flu. The office didn't save the shot into the system but once I got home and looked at the last print out they gave me and had them confirm in his medical records he was given one on 9/6/2018.
Age: 1.0
Sex: F
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Allergy to vaccine, Injection site erythema, Injection site rash, Injection site vesicles
Clinical narrative: Patient presents with 2 days of rash around the site of injection on the right thigh. Patient had received chicken pox vaccine on 12/28/2018. Two days ago, mother noted erythema to the site along with clusters of vesicles. Patient does not seem to be bothered by the rash. Family has kept it covered. There are no other associated symptoms. Review of systems otherwise negative. Varicella vaccine marked as an allergy in patient's chart.
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Abnormal behaviour, Amnesia, CSF test, Electroencephalogram, Encephalitis autoimmune
Clinical narrative: Fevers every few weeks (102-105), photophobia, memory loss, loss of consciousness, extreme behavior change, tachycardia. Diagnosis: autoimmune encephalitis. Treatment: Steroids, IVIG (Feb 2017)  Rituximab (May and July 2017).
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Immunoglobulin therapy, Loss of consciousness, Neuropsychological test, Nuclear magnetic resonance imaging, Photophobia
Clinical narrative: Fevers every few weeks (102-105), photophobia, memory loss, loss of consciousness, extreme behavior change, tachycardia. Diagnosis: autoimmune encephalitis. Treatment: Steroids, IVIG (Feb 2017)  Rituximab (May and July 2017).
Age: 7.0
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Tachycardia
Clinical narrative: Fevers every few weeks (102-105), photophobia, memory loss, loss of consciousness, extreme behavior change, tachycardia. Diagnosis: autoimmune encephalitis. Treatment: Steroids, IVIG (Feb 2017)  Rituximab (May and July 2017).
Age: 18.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Loss of consciousness
Clinical narrative: Pt was seen for his shoulder injury and was determined he was behind in immunizations. Dr. ordered immunization. Pt was given all 3 immunizations. After completion of the third immunization, Pt passed.  Pt feel back on the exam table. Pt was placed flat and recovered quickly. Patient was seen by provider for evaluation. Pt sent home without further incident.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site discolouration, Injection site swelling, Pruritus
Clinical narrative: Patient c/o slight swelling at injection site the evening after receiving influenza vaccination along with itchiness on subsequent days. Skin at left deltoid noted to have slight discoloration/bruising and very minimal swelling; skin intact and smooth to touch. No warmness or redness noted. Patient denies any hives, wheezing, shortness of breath.
Sex: M
Vaccine: VARZOS
Symptoms: Acute kidney injury, Dry eye, Fatigue, Hypoaesthesia, Muscular weakness
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) on 09-OCT-2015 from a pharmacy for its intended purpose: the prevention of shingles. On an unspecified date [reported as "shortly after" receiving the ZOSTAVAX], the patient suffered from dry eyes, blurred vision, Raynaud phenomenon, numbness, tingling, muscle weakness, muscle pain, fatigue and tiredness, and was later diagnosed with Lupus. The patient also suffered and was diagnosed with acute renal failure. As a direct and proximate result of the ZOSTAVAX vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, Lupus and acute renal failure were determined to be medically significant. Lupus, acute renal failure, and blurred vision were considered to be disabling. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Paraesthesia, Raynaud's phenomenon, Systemic lupus erythematosus, Vision blurred
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient received the ZOSTAVAX (lot number, dosage and route of administration not provided) on 09-OCT-2015 from a pharmacy for its intended purpose: the prevention of shingles. On an unspecified date [reported as "shortly after" receiving the ZOSTAVAX], the patient suffered from dry eyes, blurred vision, Raynaud phenomenon, numbness, tingling, muscle weakness, muscle pain, fatigue and tiredness, and was later diagnosed with Lupus. The patient also suffered and was diagnosed with acute renal failure. As a direct and proximate result of the ZOSTAVAX vaccine, the patient suffered painful injuries and damages, and required extensive medical care and treatment. The patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate consequence of ZOSTAVAX, the patient sustained serious personal injuries and related losses including, but not limited to, the following: The patient required and will continue to require healthcare and services; the patient incurred and will continue to incur medical and related expenses; and the patient suffered and will continue to suffer mental anguish, physical pain and suffering, diminished capacity for the enjoyment of life, a diminished quality of life, and other losses and damages. The outcome of the events was considered to be not recovered. Upon internal review, Lupus and acute renal failure were determined to be medically significant. Lupus, acute renal failure, and blurred vision were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient's healthcare provider recommended and/or prescribed the ZOSTAVAX vaccine to the patient for its intended purpose of permanent prevention and protection against shingles and zoster-related conditions. On or about 20-DEC-2008, a pharmacist at a pharmacy administered the ZOSTAVAX (lot number, dosage and route of administration) to the patient. On or about 20-DEC-2016, the patient was treated by a physician for shingles. The patient was diagnosed with shingles and/or other zoster-related injuries after and despite being inoculated with the ZOSTAVAX vaccine, and suffered serious physical, emotional, and economic damages as a result of the patient's injuries. As a direct and proximate result of the ZOSTAVAX vaccine, the patient has and will continue to suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; extensive medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs including care for hospitalization (dates unknown), physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; a diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions (unspecified); lost wages; loss of earnings capacity; and other losses and damages. The outcome of the events was considered to be not recovered. Additional information has been requested.
Age: 1.33
Sex: M
Vaccine: DTAP, HIBV, PNC13
Symptoms: Product preparation error
Clinical narrative: Initial information received on 10-Jan-2019 regarding an unsolicited valid non-serious case received from a consumer/non healthcare professional. This case involves a 16 months old male patient who was vaccinated 0.5 ml fourth dose of ACTHIB (Batch number: UI901AA and expiration date: 25-Nov-2019) via intramuscular route in the right thigh on 10-Jan-2019. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. Concomitant medications included PREVENAR 13 in the left thigh and DAPTACEL in right thigh for Immunisation. It was a case of actual medication error due to product preparation error because wrong diluent was used to mix ACTHIB. It was unknown if any adverse event occurred or not following the vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. Documents held by the sender: none.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Arthralgia, Condition aggravated, Laboratory test, Loss of personal independence in daily activities, Polymyalgia rheumatica
Clinical narrative: Severe joint pain to the point I couldn't care for myself. Developed Polymyalgia Rheumatica. I have to take Prednisone for a long period of time to keep pain down-which has bad side effects for me.
Age: 71.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Anaemia, Arthralgia, Asthenia, Blood potassium decreased, Cardiac operation
Clinical narrative: Severe joint pain to the point I couldn't care for myself. Developed Polymyalgia Rheumatica. I have to take Prednisone for a long period of time to keep pain down-which has bad side effects for me.