chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse effect; was inadvertently administerd a dose of VAQTA on4/3/2019, that was expired; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 03-APR-2019, the patient was inadvertently vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) 25/0.5 (units not reported) which expired on 02-APR-2019, lot # R006471 (dose, route and site of administration were not reported). No adverse effects were reported.
Sex: F
Vaccine: VARZOS
Symptoms: Cardiac disorder, Contusion, Herpes zoster, Pain, Pain in extremity
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX for routine health maintenance and for the prevention of shingles (lot number, dosage and route of administration not provided). The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster accompanied by pain. On an unknown date, shortly after receiving ZOSTAVAX, the patient developed bruising and pain in the arm in which the vaccine was administered. The patient also suffered a painful rash on her abdomen, chest and back, as well as cardiac complications. In response to these symptoms, the patient presented to a physician, and remains under their care. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the ZOSTAVAX. As a result of 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. The outcome of the events was considered to be not recovered.  Causality assessment was related. ZOSTAVAX did not prevent shingles, persistent strain of herpes zoster accompanied by pain, bruising and pain in the arm in which the vaccine was administered, and cardiac complications were considered to be disabling. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Information has been received regarding a case in litigation from a lawyer, a female patient of unknown age, and her spouse. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. On an unknown date, the patient was inoculated with the ZOSTAVAX for routine health maintenance and for the prevention of shingles (lot number, dosage and route of administration not provided). The ZOSTAVAX did not prevent shingles, but rather caused the patient to contract a persistent strain of herpes zoster accompanied by pain. On an unknown date, shortly after receiving ZOSTAVAX, the patient developed bruising and pain in the arm in which the vaccine was administered. The patient also suffered a painful rash on her abdomen, chest and back, as well as cardiac complications. In response to these symptoms, the patient presented to a physician, and remains under their care. As a result, the patient has suffered and will continue to suffer significant medical expenses, pain and suffering, and other damages. As a direct and proximate result of ZOSTAVAX, the patient's symptoms and diagnoses have resulted in physical limitations not present prior to using the ZOSTAVAX. As a result of 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. The outcome of the events was considered to be not recovered.  Causality assessment was related. ZOSTAVAX did not prevent shingles, persistent strain of herpes zoster accompanied by pain, bruising and pain in the arm in which the vaccine was administered, and cardiac complications were considered to be disabling. Additional information has been requested.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: herpes zoster; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient.  No information was received regarding medical history, concurrent conditions, or concomitant medications.  In 2013 (patient was approximately 86 years old at this time), the patient was prescribed zoster vaccine live (ZOSTAVAX) by a healthcare provider for the long-term prevention of shingles and zoster-related conditions.  In 2013, the patient was administered zoster vaccine live (ZOSTAVAX) by a healthcare provider at a hospital (dose, route, and lot # not provided).  On an unspecified date, the patient was treated by a healthcare provider at the same hospital for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: herpes zoster.  The outcome of herpes zoster was unknown.  Causality assessment was related.  Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Multiple sclerosis
Clinical narrative: This spontaneous report was received from a pharmacist referred to a female patient of an unknown age (college student). The patient's concurrent conditions, medical history, historical drugs, drug allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with two doses of M-M-R II (default route subcutaneous) (strength, formulation, frequency, lot# and expiry date was unknown) for prophylaxis. On an unknown date, the patient was diagnosed with multiple sclerosis. Outcome of multiple sclerosis was unknown. Causality assessment was not provided. Product quality complaint (PQC) was not found. Upon internal review, the event multiple sclerosis was determined to be medically significant.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Blood test, Diarrhoea, Headache, Musculoskeletal stiffness
Clinical narrative: This spontaneous report as received from a consumer refers to himself, a 67-year-old male patient with allergy to sulfa drugs. The patient's medical history included an open heart surgery in 2008 (reported as 11 years ago). The patient's concomitant therapies included SYNTHROID, "alapuridol" and ibuprofen. In approximately 2017 (reported as about a year and a half ago), the patient was vaccinated with the first dose of PNEUMOVAX 23 (strength, dose, frequency, route, anatomical site, lot # and expiration date were unknown) for prophylaxis. On 11-DEC-2018 (reported as four months ago), the patient experienced pneumonia, and his doctor recommended a second PNEUMOVAX 23 because of this, which was administered on 05-APR-2019 around 2:00 PM. The patient described that, at 7:00 PM he noticed severe stiffness in his neck, and by 8:00 PM he had a horrible, monumental headache. He stated that he took ibuprofen and went to sleep, but, on 06-APR-2019 at 4:00 AM he was up with uncontrollable diarrhoea. The patient also reported that musculoskeletal stiffness and headache came and went, but nothing helped, and he had taken diarrhoea medication. However, the patient had had no fever and no soreness at the shot site. The patient did not see for medical attention, but a blood work panel was done "for physical"; however the results were not provided. The patient did not received any treatment. At the reporting time, the outcome of pneumonia was reported as recovered on an unknown date. Nevertheless, the outcome of musculoskeletal stiffness, headache and diarrhoea were reported as not recovered. The causality between PNEUMOVAX 23 and the reported events was unknown. Upon internal review, pneumonia was considered to be medically significant.
Sex: U
Vaccine: TDAP
Symptoms: Fall, Head injury, Syncope
Clinical narrative: This case was reported by a consumer and described the occurrence of syncope in a adult patient who received BOOSTRIX for prophylaxis. On 29th March 2019, the patient received BOOSTRIX. On an unknown date, less than a month after receiving BOOSTRIX, the patient experienced syncope (serious criteria GSK medically significant), fall and head injury. On an unknown date, the outcome of the syncope, fall and head injury were unknown. It was unknown if the reporter considered the syncope, fall and head injury to be related to BOOSTRIX. Additional details were provided as follow: The age at vaccination was not reported. The BOOSTRIX received by one of associate during the normal course of business. No additional information was provided. The reporter consented to follow up.
Sex: U
Vaccine: FLUX
Symptoms: Anaphylactic reaction, Vaccination complication
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of anaphylactic reaction in a patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine at an unknown dose. On an unknown date, unknown after receiving Flu vaccine, the patient experienced anaphylactic reaction (serious criteria GSK medically significant). On an unknown date, the outcome of the anaphylactic reaction was unknown.  It was unknown if the reporter considered the anaphylactic reaction to be related to Flu vaccine. Additional details were provided as follows: The age at vaccination was not reported. The pharmacist reported that the patient experienced a documented anaphylaxis to influenza vaccine.
Sex: M
Vaccine: PNC13
Symptoms: Injection site induration
Clinical narrative: Was a hard spot where the injection was placed; This is a spontaneous report from a contactable consumer (Patient's mother).  A 10-month-old male patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) via an unspecified route of administration at single dose on 01Apr2019 for immunisation.   The patient medical history and concomitant medications were not reported.  The patient developed a hard spot where the injection was placed on 02Apr2019. The outcome of the event was unknown.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Feeling abnormal, Influenza like illness, Injection site swelling, Injection site warmth
Clinical narrative: Went to exercise after injection. Became weak experiencing "rubbery legs" to where had to stop exercising. Began feeling "bad all over" like flu-like symptoms. Legs weak. Injection site became swollen & hot to touch which lasted 5 days. Felt OK for 2 days but then on 4-8-19 awoke to find mouth burning & had very painful "sores" on right side of mouth on gums & roof of mouth which lasted 7 days. Awoke on 4-15-19 feeling much better with no complaints.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of control of legs, Muscular weakness, Oral discomfort, Stomatitis
Clinical narrative: Went to exercise after injection. Became weak experiencing "rubbery legs" to where had to stop exercising. Began feeling "bad all over" like flu-like symptoms. Legs weak. Injection site became swollen & hot to touch which lasted 5 days. Felt OK for 2 days but then on 4-8-19 awoke to find mouth burning & had very painful "sores" on right side of mouth on gums & roof of mouth which lasted 7 days. Awoke on 4-15-19 feeling much better with no complaints.
Age: 58.0
Sex: F
Vaccine: MMR
Symptoms: Arthralgia, Fatigue, Myalgia
Clinical narrative: Approx. 10  days post vaccination, HCW reports increased tiredness, generalized  joint and muscle pain.  Symptoms lasted for 48 hrs.   Took Advil with relief.  There were no evidence of a vaccine reaction at the injection site.  No redness, swelling or tenderness was noted.
Age: 77.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Night sweats
Clinical narrative: Pt reported today for one week of pain and swelling of the injection sight, and night sweats after injection, right shoulder visibly swollen, denied any rashes, throat tightening, or shortness of breath (out of norm, he has chronic copd) Pt instructed to take Tylenol for fever and pain and to ice the arm on/off for 15 min for next 3 days
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation error
Clinical narrative: No adverse event. Client did not receive vaccine she thought she received. Powdered vial given with sterile water instead of diluent.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Contusion, Erythema, Swelling
Clinical narrative: Patient experienced redness and mild swelling.  Also some bruising.
Age: 1.5
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This child is 18 months old and should have gotten fluzone 0.25mg. I gave 0.5ml dose. I contacted the parent and he was notified of wrong dose given. RN on staff did notify him of increased risk of redness and swelling at site and possible fever. Employee was notified and she advised that parent and supervisor must be notified which they both were. Incident form filled out for our office. Child and parents did remain in the office for longer than 15 minutes and the child had no reaction at that time.
Age: 29.0
Sex: F
Vaccine: HEP
Symptoms: Headache, Musculoskeletal pain, Pain in extremity, Tremor
Clinical narrative: Patient reported feeling fine the day of vaccination but when she woke up the next morning she had a headache. Around 1:00 pm when she was getting ready for work she started feeling shaky so she ate and then felt better. She went to work at 3:00. After being at work for about 45 minutes the headache and shakiness came back. She later started having pain in her lower legs and shoulders. She left work at 8:00 due to head ache and pain in legs and shoulders. She still felt shaky and had a mild headache the next day.  Her symptoms were completely resolved by 4/12/19.
Age: 2.0
Sex: F
Vaccine: DTAP, IPV, MMR
Symptoms: Injection site inflammation, Injection site pruritus, Injection site swelling, Vaccination complication
Clinical narrative: WHOLE LEFT THIGH SWELLED UP THE SIZE OF A SOFTBALL AND WAS SEVERELY INFLAMED AND ITCHY.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Feeling abnormal, Lipids, Memory impairment
Clinical narrative: Pt's mother reports that approx 1 hr after receiving vaccines, pt started acting "spacey". He was not able to remember what he was ordering at a restaurant. He was not able to follow simple instructions at home. He was told to throw something into the garbage and instead put it in his room, he was told to put Mom's hairspray in the bathroom but instead he put it in the recycle container. The next day he was slightly better but still off. By the next day, he was back to normal.
Sex: U
Vaccine: DTAP, IPV, MMRV
Symptoms: Cough, Ocular hyperaemia, Pruritus, Rash generalised
Clinical narrative: Started with itchy skin, red eyes, slight cough and rash on entire body.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Bursa disorder, Bursitis, Mobility decreased, Musculoskeletal pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: So I had a long discussion with this patient about her experience after receiving the SHINGRIX vaccine on 2/20/18. She stated that right after she received the shot her arm hurt for a few days and she had a hard time lifting her arm (for Zumba). She figured this was a typical reaction to a vaccine so did not worry about it. The shoulder pain persisted so she ended up doing PT and using a variety of topicals to treat the pain. After months and months of no change or improvement, she saw an MD who did an MRI to confirm that she had bursitis with a tear in her bursa. The MD told her it was the result of improper vaccine administration (too high and too deep she stated). She is due to have surgery to repair the tear on 4/22/19 and is expected to have 6 months of PT as follow up.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Product administered at inappropriate site, Surgery, Vaccination error
Clinical narrative: So I had a long discussion with this patient about her experience after receiving the SHINGRIX vaccine on 2/20/18. She stated that right after she received the shot her arm hurt for a few days and she had a hard time lifting her arm (for Zumba). She figured this was a typical reaction to a vaccine so did not worry about it. The shoulder pain persisted so she ended up doing PT and using a variety of topicals to treat the pain. After months and months of no change or improvement, she saw an MD who did an MRI to confirm that she had bursitis with a tear in her bursa. The MD told her it was the result of improper vaccine administration (too high and too deep she stated). She is due to have surgery to repair the tear on 4/22/19 and is expected to have 6 months of PT as follow up.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Joint injection, Loss of personal independence in daily activities, Musculoskeletal pain, Pain
Clinical narrative: My arm has never recovered from this shot given 10/12/2018. The pain in the shoulder has burned, ached, radiated down to the mid arm and there is severe loss of strength and mobility with pain. I have been forced to take over the counter pain medication daily to tolerate the pain. I have used a lidocaine patch during the day and a heating pad at night. I had a steroid injection trying to relieve the pain in January,4 2019 from Dr. Back to Dr March 15,2019 to get another injection. He did not treat but recommended I get ultra sound. I then went to a Sports Med Dr. on March 18, 2019 who did an ultrasound to see if there was a tear. No tear. Then went to a PT March 20, 2019 to get exercises to help. The exercises hurt so bad that I could only do them on my days off because of the pain it caused after. It has caused issue with the work and daily routine as well. I was doing yoga 3-4 days a week. I have gone to one day a week with much modification.
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Ultrasound scan normal
Clinical narrative: My arm has never recovered from this shot given 10/12/2018. The pain in the shoulder has burned, ached, radiated down to the mid arm and there is severe loss of strength and mobility with pain. I have been forced to take over the counter pain medication daily to tolerate the pain. I have used a lidocaine patch during the day and a heating pad at night. I had a steroid injection trying to relieve the pain in January,4 2019 from Dr. Back to Dr March 15,2019 to get another injection. He did not treat but recommended I get ultra sound. I then went to a Sports Med Dr. on March 18, 2019 who did an ultrasound to see if there was a tear. No tear. Then went to a PT March 20, 2019 to get exercises to help. The exercises hurt so bad that I could only do them on my days off because of the pain it caused after. It has caused issue with the work and daily routine as well. I was doing yoga 3-4 days a week. I have gone to one day a week with much modification.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain of skin, Tenderness
Clinical narrative: Patient described headache and scalp pain/tenderness in the upper-left quadrant of his face and head, including his left eye socket. He reported that this is the same area and pain he experienced when he had a shingles infection in the past. This started days after administration and persisted over the weekend of 4/12/19. He tried taking Tylenol OTC and had no benefit. The pain/headache got so bad it was causing him to be nauseous and he vomited the evening of 4/13/19. He also reported fatigue and related oversleeping throughout the weekend. His symptoms are steadily improving now but are still very bad. I recommended that he seek care from his primary care physician to be further examined.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Patient described headache and scalp pain/tenderness in the upper-left quadrant of his face and head, including his left eye socket. He reported that this is the same area and pain he experienced when he had a shingles infection in the past. This started days after administration and persisted over the weekend of 4/12/19. He tried taking Tylenol OTC and had no benefit. The pain/headache got so bad it was causing him to be nauseous and he vomited the evening of 4/13/19. He also reported fatigue and related oversleeping throughout the weekend. His symptoms are steadily improving now but are still very bad. I recommended that he seek care from his primary care physician to be further examined.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash across patient's chest.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Patient experienced injection site reaction
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Blood test, Chest X-ray abnormal, Chills, Heart rate increased
Clinical narrative: 103 degree fever, chills, nausea, high heart rate and high blood pressure. High heart rate continued and I went to ER on 4/3/2019, and again on 4/4/2019 when I was admitted to the hospital and diagnosed with A-fib. High heart rate continued and I was readmitted to the hospital on 4/12/19. Dr., who was the doctor in the hospital, indicated that after further research he felt that the A-fib had been caused by the shingles shot I received on 3/21/2019. Dr. recommended that I report my case to the CDC.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension, Nausea, Pleural effusion, Pyrexia
Clinical narrative: 103 degree fever, chills, nausea, high heart rate and high blood pressure. High heart rate continued and I went to ER on 4/3/2019, and again on 4/4/2019 when I was admitted to the hospital and diagnosed with A-fib. High heart rate continued and I was readmitted to the hospital on 4/12/19. Dr., who was the doctor in the hospital, indicated that after further research he felt that the A-fib had been caused by the shingles shot I received on 3/21/2019. Dr. recommended that I report my case to the CDC.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Patient came to the pharmacy today and complained about the side effect of the vaccination that she received on 4/11/2019.   At the injection site, the redness spread out up to almost 4 inches.  It was warm and tender. Patient also complained about itchiness around the injection site.   She was advised by the pharmacist to apply cold compress for the swelling; Benadryl to take care of the itchiness and Tylenol as needed for the uncomfortable.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: Patient came to the pharmacy today and complained about the side effect of the vaccination that she received on 4/11/2019.   At the injection site, the redness spread out up to almost 4 inches.  It was warm and tender. Patient also complained about itchiness around the injection site.   She was advised by the pharmacist to apply cold compress for the swelling; Benadryl to take care of the itchiness and Tylenol as needed for the uncomfortable.
Age: 13.0
Sex: F
Vaccine: MNQ
Symptoms: Pain, Peripheral swelling
Clinical narrative: swollen arm & pain started the day after the injection. Taking ibuprofen every 6 hrs. cold compress applied without relieve
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Blood culture negative, Culture urine negative, Febrile convulsion, Full blood count normal, Influenza virus test negative
Clinical narrative: 1 hour after receiving vaccines, patient developed a low grade fever that progressively increased to 105F in the middle of the night. She then had a shaking and unresponsive episode that was consistent with a febrile seizure. No other symptoms.  Presented to hospital that evening.
Age: 0.67
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Metabolic function test normal, Pyrexia, Tremor, Unresponsive to stimuli, Urine analysis normal
Clinical narrative: 1 hour after receiving vaccines, patient developed a low grade fever that progressively increased to 105F in the middle of the night. She then had a shaking and unresponsive episode that was consistent with a febrile seizure. No other symptoms.  Presented to hospital that evening.
Age: 4.0
Sex: F
Vaccine: MMRV, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Pneumonia, Rash generalised, Seizure
Clinical narrative: Swelling around the injection site, redness, seizures, pneumonia, and rash all over the body
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Asthenia, Fatigue, Injection site warmth
Clinical narrative: Pt stated she felt hot at site of injection. Pt stated she felt very low energy or tired for 2 days after injection was given. Pt stated she also had stomach upset.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event, Product storage error
Clinical narrative: Administered vaccine which had been exposed to a low temp of 31.3F. No adverse event reported by patient.  Contacted Pfizer: Vaccine can be exposed to less than 23f for over 7 days. My vaccine was exposed to temps between 31.3 an 32f for a cumulative exposure of less than 8 hours.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Patient reported rash on her forehead that do not tingle, is itchy, and is bilateral.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Full body pain for 36 hours
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: On April 13, 2019 patient came to the pharmacy and reported that her arm felt hot and warm to the touch. Patient showed pharmacist her arm over the weekend. Patient's arm was red, hot to the touch and swollen length wise along her arm. Patient was instructed to take an anti-inflammatory for the swelling and to contact her physician if it had gotten worse. Patient came back to the pharmacy Monday evening at 6:30pm and reported that she had to go to the ER to be seen. The patient was in excruciating pain Saturday night through Sunday morning. Her arm continued to swell. The patient reported to the pharmacist the ER physician wasn't sure the cause but determined it could have been cellulitis due to a reaction from the vaccination. The patient was prescribed keflex to take for 10 days along with tramadol for pain. On Monday evening, the swelling was noticeably down compared to Saturday but still prominent, hot to the touch and painful. Patient was instructed to continue taking the antibiotic and if the swelling continued to get worse to go back to the ER for evaluation.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Asthenia, Back pain, Chills, Decreased appetite
Clinical narrative: Had the vaccine around 2 PM. Felt kind of tired later in the day and little appetite for dinner. Around 12 midnight (AM) that night, I felt a bit unwell - mild nausea/slight stomach ache. By 1 AM I began shivering, it became uncontrollable. I put on extra clothing but couldn't get warm. The shivering was pronounced, and lasted 3 plus hours almost continuously. My hands felt cold and a bit numb. After the 3 initial hours, there were a few brief mild bouts of shivering into the next midmorning. Aches - During the night, my shoulders began to feel a bit stiff and sore. By morning, my shoulders became sore, then my neck, especially to the base of the skull, and accompanied by a headache, feeling like pressure behind the eyes, and at the base of the skull. The next day, the mild nausea came back a few times, it was not intense but it was noticeable and I took some TUMS, and kept a mild diet that day and the following. During the second day, Wed, the achiness extended to the middle of my back, and I continued to feel weak and a bit woozy, activity was an effort, my head throbbed, and I ended up keeping to bed most of the day. I checked the paperwork, the pharmacist had told me some people experience this vaccine as worse than most vaccines, and feel it for 2-3 days anecdotally. The symptoms I felt seemed to be on the list of possible side effects, which I wish I'd known in advance - would have planned to take it when I had a few days to spare. I put in a call to my PCP to notify them, but didn't go in, as it was too much effort, and not sure what they could do to help anyway. ADVIL and Acetaminophen helped somewhat with the aches. After 36-48 hours, I felt normal temperature on the third day, and the headache abated, by midnight of the second day (Wed) 34 hrs, the feeling of weakness and exhaustion passed, and the following day, Thurs, by evening the aches had subsided, about 55 hrs after vaccination. Some injection site pain lasted longer, about 5 days, over an area the size of my palm.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Fatigue, Feeling cold, Headache, Hypoaesthesia
Clinical narrative: Had the vaccine around 2 PM. Felt kind of tired later in the day and little appetite for dinner. Around 12 midnight (AM) that night, I felt a bit unwell - mild nausea/slight stomach ache. By 1 AM I began shivering, it became uncontrollable. I put on extra clothing but couldn't get warm. The shivering was pronounced, and lasted 3 plus hours almost continuously. My hands felt cold and a bit numb. After the 3 initial hours, there were a few brief mild bouts of shivering into the next midmorning. Aches - During the night, my shoulders began to feel a bit stiff and sore. By morning, my shoulders became sore, then my neck, especially to the base of the skull, and accompanied by a headache, feeling like pressure behind the eyes, and at the base of the skull. The next day, the mild nausea came back a few times, it was not intense but it was noticeable and I took some TUMS, and kept a mild diet that day and the following. During the second day, Wed, the achiness extended to the middle of my back, and I continued to feel weak and a bit woozy, activity was an effort, my head throbbed, and I ended up keeping to bed most of the day. I checked the paperwork, the pharmacist had told me some people experience this vaccine as worse than most vaccines, and feel it for 2-3 days anecdotally. The symptoms I felt seemed to be on the list of possible side effects, which I wish I'd known in advance - would have planned to take it when I had a few days to spare. I put in a call to my PCP to notify them, but didn't go in, as it was too much effort, and not sure what they could do to help anyway. ADVIL and Acetaminophen helped somewhat with the aches. After 36-48 hours, I felt normal temperature on the third day, and the headache abated, by midnight of the second day (Wed) 34 hrs, the feeling of weakness and exhaustion passed, and the following day, Thurs, by evening the aches had subsided, about 55 hrs after vaccination. Some injection site pain lasted longer, about 5 days, over an area the size of my palm.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Malaise, Musculoskeletal pain, Musculoskeletal stiffness, Nausea
Clinical narrative: Had the vaccine around 2 PM. Felt kind of tired later in the day and little appetite for dinner. Around 12 midnight (AM) that night, I felt a bit unwell - mild nausea/slight stomach ache. By 1 AM I began shivering, it became uncontrollable. I put on extra clothing but couldn't get warm. The shivering was pronounced, and lasted 3 plus hours almost continuously. My hands felt cold and a bit numb. After the 3 initial hours, there were a few brief mild bouts of shivering into the next midmorning. Aches - During the night, my shoulders began to feel a bit stiff and sore. By morning, my shoulders became sore, then my neck, especially to the base of the skull, and accompanied by a headache, feeling like pressure behind the eyes, and at the base of the skull. The next day, the mild nausea came back a few times, it was not intense but it was noticeable and I took some TUMS, and kept a mild diet that day and the following. During the second day, Wed, the achiness extended to the middle of my back, and I continued to feel weak and a bit woozy, activity was an effort, my head throbbed, and I ended up keeping to bed most of the day. I checked the paperwork, the pharmacist had told me some people experience this vaccine as worse than most vaccines, and feel it for 2-3 days anecdotally. The symptoms I felt seemed to be on the list of possible side effects, which I wish I'd known in advance - would have planned to take it when I had a few days to spare. I put in a call to my PCP to notify them, but didn't go in, as it was too much effort, and not sure what they could do to help anyway. ADVIL and Acetaminophen helped somewhat with the aches. After 36-48 hours, I felt normal temperature on the third day, and the headache abated, by midnight of the second day (Wed) 34 hrs, the feeling of weakness and exhaustion passed, and the following day, Thurs, by evening the aches had subsided, about 55 hrs after vaccination. Some injection site pain lasted longer, about 5 days, over an area the size of my palm.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Ocular discomfort, Pain, Peripheral coldness
Clinical narrative: Had the vaccine around 2 PM. Felt kind of tired later in the day and little appetite for dinner. Around 12 midnight (AM) that night, I felt a bit unwell - mild nausea/slight stomach ache. By 1 AM I began shivering, it became uncontrollable. I put on extra clothing but couldn't get warm. The shivering was pronounced, and lasted 3 plus hours almost continuously. My hands felt cold and a bit numb. After the 3 initial hours, there were a few brief mild bouts of shivering into the next midmorning. Aches - During the night, my shoulders began to feel a bit stiff and sore. By morning, my shoulders became sore, then my neck, especially to the base of the skull, and accompanied by a headache, feeling like pressure behind the eyes, and at the base of the skull. The next day, the mild nausea came back a few times, it was not intense but it was noticeable and I took some TUMS, and kept a mild diet that day and the following. During the second day, Wed, the achiness extended to the middle of my back, and I continued to feel weak and a bit woozy, activity was an effort, my head throbbed, and I ended up keeping to bed most of the day. I checked the paperwork, the pharmacist had told me some people experience this vaccine as worse than most vaccines, and feel it for 2-3 days anecdotally. The symptoms I felt seemed to be on the list of possible side effects, which I wish I'd known in advance - would have planned to take it when I had a few days to spare. I put in a call to my PCP to notify them, but didn't go in, as it was too much effort, and not sure what they could do to help anyway. ADVIL and Acetaminophen helped somewhat with the aches. After 36-48 hours, I felt normal temperature on the third day, and the headache abated, by midnight of the second day (Wed) 34 hrs, the feeling of weakness and exhaustion passed, and the following day, Thurs, by evening the aches had subsided, about 55 hrs after vaccination. Some injection site pain lasted longer, about 5 days, over an area the size of my palm.
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Arthralgia, Decreased appetite, Feeling cold, Headache, Injection site pain
Clinical narrative: The evening of the immunizations, patient described having arm pain, (more severe than the first shot), headache, joint aches, shaky feeling, couldnt get warm and couldnt sleep. The next day the symptoms persisted and she had no appetite.By the third day, she was feeling better, but the injection site pain and headache were still bothering her.
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Insomnia, Nervousness, Pain in extremity
Clinical narrative: The evening of the immunizations, patient described having arm pain, (more severe than the first shot), headache, joint aches, shaky feeling, couldnt get warm and couldnt sleep. The next day the symptoms persisted and she had no appetite.By the third day, she was feeling better, but the injection site pain and headache were still bothering her.
Age: 52.0
Sex: F
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Insomnia, Pain
Clinical narrative: The patient received the Adacel vaccine on April 10, 2019.  This is April 15, 2019.  She called the pharmacy and reported she has felt a throbbing pain that got worse after each day from receiving the shot. She mention there is no swelling/redness at the injection site; however, she is unable to sleep on the injected arm site during the night, and she struggled raising her arm above her head.  She did allow one of her doctors to check her shoulder, and he also showed concern with this condition.   I have recommended her to visit her primary care physician in order to assess a therapy to relieve this condition.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Flu like symptoms, swelling and redness at site of shot.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient called on 4/15/2019 reporting redness at the injection site, swelling, tenderness, warmth, and a ring around the site. The patient was advised to go to the doctor.
Age: 64.0
Sex: M
Vaccine: UNK
Symptoms: Fatigue, Myalgia, Sensitive skin
Clinical narrative: myalgia, fatigue, and skin sensitivity in hip and leg on left side has persisted for 7 days
Age: 55.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Painful arm, rash.
Age: 36.0
Sex: F
Vaccine: HEPAB, VARCEL
Symptoms: Cellulitis, Feeling abnormal, Peripheral swelling, Pyrexia, Vomiting
Clinical narrative: Client received vaccinations on 04/11/2019 at approximately 9:30am. By 6pm on 04/12/2019, client reports that started running fever of 100 and having swelling in her right arm where the varicella was given. States she took TYLENOL and Ibuprofen alternately. States on Sat. 04/13/2019 while at work she began to feel worse and started vomiting with fever now of 102.8. States left work and went to the ER at 11:24pm where she was diagnosed with cellulitis. States was placed on BACTRIM DS and Hydrocortisone. States is still taking her antibiotic but her arm is much better.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Depression, Hallucination, auditory, Suicide attempt
Clinical narrative: Pt received HPV9 along with Tdap and MCV4 at age 11 yrs on 9/28/17. 1-2 months later, he complained of hearing voices and hurt himself, depressed. Admitted to hospital on 6/18/18 for suicide attempt. No prior h/o mental problems.
Age: 36.0
Sex: M
Vaccine: TDAP
Symptoms: Muscle tightness, Pain in extremity
Clinical narrative: patient came in today stating that his right arm still hurts significantly from the shot he received on 4-05-2019. said that the muscles in his arm will tighten up and then relax after an hour or two repeatedly throughout the day. externally, his arm has no signs of redness, swelling or infection. advised pt to see a doctor if symptoms continue
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Pain
Clinical narrative: The patient developed an area of redness, soreness around 1230 the day after his immunization. There was no fever. Due to his intellectual disability and the face he's non-verbal, difficult to determine if there was pain. No induration.
Age: 12.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Contusion, Dizziness, Nausea, Rash, Syncope
Clinical narrative: Pt had a syncope episode right before leaving the clinic. Pt O/A for bumps/bruises. Eyes were PERRLA. Pt saw provider. Pt was offered emesis bag and water. Pt instructed to continue to lie down where she was in a safe area until she no longer felt dizzy and N/V, and increased strength. Pt was advised to increase fluid intake and food intake. Pt stated not eating very much and not drinking water that am.
Age: 12.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Vomiting
Clinical narrative: Pt had a syncope episode right before leaving the clinic. Pt O/A for bumps/bruises. Eyes were PERRLA. Pt saw provider. Pt was offered emesis bag and water. Pt instructed to continue to lie down where she was in a safe area until she no longer felt dizzy and N/V, and increased strength. Pt was advised to increase fluid intake and food intake. Pt stated not eating very much and not drinking water that am.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Angioedema, Headache, Rash generalised, Rash pruritic, Vertigo
Clinical narrative: 24 hours after HPV9 given pt. had a HA and vertigo, was fine the next 24 hours, then rash head to toe x 7d, faint itchy rash today and better after 2 doses of prednisone. Angioedema 3 days after immunizations.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Depression, Suicidal ideation
Clinical narrative: Pt received 2 doses of HPV9 vaccine 6/5/17 and 7/6/17. Went away for college in Aug 2017. Pt started symptoms of depression 2-3 months after 2nd dose of HPV9. He dropped out of college in April 2018, became suicidal in June. I saw him in June 2018, referred him to psychiatrist. He has no prior H/O mental problem/depression.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: Redness to (L) arm. Hardness to injection sight Benadryl given.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient informed that since the same day, later at night, her arm was swollen at the injection site and feeling warm and pained. She called two days later to the pharmacy and we recommended that she visits her doctor. She did so and informed MD didn't prescribed her any medication.
Age: 12.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness, Pallor
Clinical narrative: Child became pale and dizzy. He rested with his feet up, had BP taken twice and had oral fluids. After 20 minutes he was feeling better; he left office after 35 minutes.
Age: 18.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Friday afternoon, 4/12/19, face became itchy and developed hives, took BENADRYL, came to pediatrician. Left earlobe also red, itchy. Took BENADRYL again Friday night. Symptoms resolved. Took ZYRTEC Saturday, symptoms did not return.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: (L) ARM: Swelling               redness               Painful
Age: 72.0
Sex: F
Vaccine: MMR
Symptoms: Arthritis, Rash, Rash erythematous, Rash maculo-papular
Clinical narrative: erythematous maculopapular rash chest/abd.  face.   arthritis (R) wrist +(L) MCP jt #1
Age: 21.0
Sex: F
Vaccine: JEV1, RAB, TYP
Symptoms: Dizziness
Clinical narrative: Patient received Ixiaro, Rabavert and Typhim Vi injections upon admin of final shot, Typhim, patient felt faint and dizzy which persisted for 20 minutes. Patient recovered and taken home by a friend
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Fixed eruption, Urticaria
Clinical narrative: Urticarial rash vs fixed drug eruption (R) arm, not at injection site. Tx'ed with topical BENADRYL and topical steroid cream resolved in 1 week.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Musculoskeletal pain, Rash
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant medication use were not provided. In or around 29-JUL-2017, the patient was inoculated with ZOSTAVAX (lot number, expiration, dose and route unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Approximately a week after receiving ZOSTAVAX vaccine, the patient suffered pain on her buttocks that progressed to a painful rash. The patient was then diagnosed with herpes zoster outbreak.  As a direct and proximate result of ZOSTAVAX, the patient's symptoms have resulted in physical limitations not present prior to using ZOSTAVAX. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of her condition.  As a result of the ZOSTAVAX, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence the patient experienced 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. The patient has suffered and incurred damages including medical expenses; loss of accumulations; and other economic and noneconomic damages. Treatment of event was unknown. Outcome of event was not recovered. Causality assessment was related. Herpes zoster outbreak was considered to be disabling.  Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Swelling; Hot/ hot to touch; Inflammed; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 61-year-old female patient who received SHINGRIX (batch number BF4J5, expiry date 5th July 2021) for prophylaxis. On 5th April 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 6th April 2019, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, feeling hot and injection site inflammation. The patient was treated with antiinflammatory/antirheumatic products (Anti-Inflammatory) and medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the extensive swelling of vaccinated limb, feeling hot and injection site inflammation were recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb, feeling hot and injection site inflammation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. On the next day after vaccination, the patient woke up with 4 inch circle about 1 inch below the injection site associated with swelling, inflammation and hot to touch. The patient was getting better at the time of reporting. The pharmacist advised the patient to use ice pack and anti-inflammatory medication. No further details were provided at time of reporting.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extensive swelling of vaccinated limb, Feeling hot, Injection site inflammation
Clinical narrative: Swelling; Hot/ hot to touch; Inflammed; This case was reported by a pharmacist via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 61-year-old female patient who received SHINGRIX (batch number BF4J5, expiry date 5th July 2021) for prophylaxis. On 5th April 2019, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 6th April 2019, 1 days after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, feeling hot and injection site inflammation. The patient was treated with antiinflammatory/antirheumatic products (Anti-Inflammatory) and medication unknown (Ice Pack (Nos)). On an unknown date, the outcome of the extensive swelling of vaccinated limb, feeling hot and injection site inflammation were recovering/resolving. It was unknown if the reporter considered the extensive swelling of vaccinated limb, feeling hot and injection site inflammation to be related to SHINGRIX. Additional details were provided as follows: The patient received SHINGRIX in the right deltoid. On the next day after vaccination, the patient woke up with 4 inch circle about 1 inch below the injection site associated with swelling, inflammation and hot to touch. The patient was getting better at the time of reporting. The pharmacist advised the patient to use ice pack and anti-inflammatory medication. No further details were provided at time of reporting.