chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: MNQ
Symptoms: Anaphylactic reaction, Dyspnoea, Nasal congestion, Nasal oedema
Clinical narrative: he had an anaphylactic reaction about 10 to 15 minutes after the vaccine; nose became completely blocked. He complained of not being able to breathe through his nose and his nose appeared swollen; nose became completely blocked. He complained of not being able to breathe through his nose and his nose appeared swollen; nose became completely blocked. He complained of not being able to breathe through his nose and his nose appeared swollen; Initial information received on 30-Apr-2019 regarding an unsolicited valid serious case received from a consumer/non-health care professional.  This case involves a male patient of unknown age for whom it was reported that nose became completely blocked. He complained of not being able to breathe through his nose and his nose appeared swollen, he had an anaphylactic reaction about 10 to 15 minutes after the vaccine MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE [MENACTRA].  The patient has Milk allergy.   The patient's past medical treatment(s), vaccination(s), concomitant medication(s) and family history were not provided.  No other vaccines was given.  On an unspecified date of June-2018, the patient received a first dose of suspect MENINGOCOCCAL A-C-Y-W135 (D CONJ) VACCINE lot number not reported via unknown route in deltoid nos.  On an unknown date in Jun-2018, 10 to 15 minutes after the vaccination the patient had anaphylactic reaction with nose became completely blocked (nasal congestion) and complained of not being able to breathe through his nose (dyspnoea) and nose appeared swollen (nose oedema). Anaphylactic reaction was assessed as medically significant.  The patient was taken to doctor's office. The reported wanted to confirm if Menactra contains components derived from milk, as the patient had milk allergy.  (Other relevant tests included no lab data.)  Final diagnosis was anaphylactic reaction and breathing difficult.  The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) and nebulizer.  The outcome of the events was reported as recovered on an unknown date.  Information on the batch number was requested.  List of documents held by sender: none.; Sender's Comments: This case involves a male patient who experienced anaphylactic reaction and breathing difficulty after vaccination. Anaphylactic reaction was assessed as medically significant. The patient's past medical history included Milk allergy. Time to onset is compatible with the role of vaccine. More details regarding patient's previous vaccination history, history of similar episode, etiological workup and investigation reports to identify alternative etiology are needed for complete assessment of the case. Based on the available information the role of vaccine cannot be assessed.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Patient has cellulitis at injection site and is being treated with Keflex
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: LEFT ARM RED AND SLIGHTLY WARM TO TOUCH, SMALL AMOUNT OF SWELLING
Age: 53.0
Sex: F
Vaccine: DTAP, VARZOS
Symptoms: Chills, Fatigue, Headache, Pain
Clinical narrative: Headache and fatigue lasting 3 days, shivers lasting through the night, body aches lasting 2 days.  Treatment consisted of rest at home.
Age: 30.0
Sex: F
Vaccine: UNK
Symptoms: Pain in extremity
Clinical narrative: Very sore arm, at least 24 hours now
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Bone pain, Impaired work ability, Injection site bruising, Pain
Clinical narrative: Nurse warned me to take pain medication after the injection, which I did - one ibuprofen 200 mg and one tylenol 500 mg. I didn't really take this seriously as I don't normally take pain medication even for a dtap or similar vaccine which typically causes soreness at the injection site. In this case, not only was there soreness at the injection site 4 hours later, but throughout the next day, the pain in my left arm was 4-5 inches around the injection site - nearly down to my elbow. This pain didn't completely diminish for at least a week. I also had body aches the following day as well as the day after in my bones and joints. This was very uncomfortable and made it difficult to carry out my duties at work.  There was also a large bruise at the injection site - a white spot surrounded by a livid bruise around that. People who saw it found it startling; I also took pictures. Now two weeks later this bruise is not completely gone.  I have traveled widely overseas and had many vaccinations, including typhoid. This is the worst vaccine experience I've had. I have warned my elderly parents to never take this vaccine.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccination site pain
Clinical narrative: Nurse warned me to take pain medication after the injection, which I did - one ibuprofen 200 mg and one tylenol 500 mg. I didn't really take this seriously as I don't normally take pain medication even for a dtap or similar vaccine which typically causes soreness at the injection site. In this case, not only was there soreness at the injection site 4 hours later, but throughout the next day, the pain in my left arm was 4-5 inches around the injection site - nearly down to my elbow. This pain didn't completely diminish for at least a week. I also had body aches the following day as well as the day after in my bones and joints. This was very uncomfortable and made it difficult to carry out my duties at work.  There was also a large bruise at the injection site - a white spot surrounded by a livid bruise around that. People who saw it found it startling; I also took pictures. Now two weeks later this bruise is not completely gone.  I have traveled widely overseas and had many vaccinations, including typhoid. This is the worst vaccine experience I've had. I have warned my elderly parents to never take this vaccine.
Age: 1.25
Sex: M
Vaccine: DTAP, HEPA, HIBV, MMRV, PNC13
Symptoms: Drooling, Rash, Rash erythematous, Swelling
Clinical narrative: Child received vaccines around 1030 AM. Mom took the child to grandmother's house around 12:00 and he looked normal at that time. Mom picked the child up around 4:00 pm and she noticed swelling underneath his chin, redness to raised area, and a red rash on right cheek. Back with a little rash that appears the same as chin and cheek rash. Mom called triage who advised her to take the child to the ER. Mom presented to the urgent care within the same facility as writer's office. Urgent care sent child to be seen in the pediatric department. Writer promptly evaluated child. Child was happy, sitting on the exam table. Firm swollen mass under chin not extending completely to neck. Right cheek and upper back appeared red. No hives. Breathing appeared normal without distress or stridor. Oxygen level was 97% in office. Excessive drooling was noticed, mom reports that this is unusual for him. Child was sent to the emergency room for further evaluation via private vehicle.
Age: 17.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse event noted. Patient received adult dose of Hep A
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Influenza like illness, Limb discomfort, Nausea
Clinical narrative: Sore arm,101 fever,nausea,overall flu feeling
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Back pain, Chills, Fatigue, Myalgia, Neck pain
Clinical narrative: muscle pain  in  back and neck chills fatigue
Age: 0.58
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Hypersensitivity, Injection site rash, Peripheral swelling, Rash
Clinical narrative: Pt Mom received a call from pt daycare at 1240 on 4/24/19 telling her that her daughter had a rash on BL legs from knees to feet and that her left foot was swollen and the right one was starting to swell.  Pt Mom was directed to take her daughter into the ER to be evaluated. Pt was treated for allergic reaction and released to home with no medications. Pt f/u with provider on 5/7/19, both feet still swollen, but the swelling has considerably decreased, along with the redness and the rash did not spread, but has decreased.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Back pain, Chest pain, Headache, Oropharyngeal pain, Pain in extremity
Clinical narrative: Patient complained of chest pain, throat pain, headache,back pain and pain in in both arms that stared 5/3/19 in the afternoon and lasted for 2-3 days after the vaccines were administered.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site erythema
Clinical narrative: There was a large amount of redness to the site of injection one week after the injection
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Cellulitis, Pyrexia, Skin exfoliation, Subcutaneous abscess
Clinical narrative: youth given vaccine on Thursday May 2nd, youth began running a fever Thursday night that lasted through Saturday, temperature reaching 103.2 degrees. On Monday May 6th youth's skin is peeling badly just like a sunburn but youth has not been in the sun without his shirt on. Youth has cellulitis/abscess noted today to left underarm.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cold sweat, Dizziness, Pain, Secretion discharge
Clinical narrative: After 10 minutes of getting the vaccine I felt mildly light headed, which lasted 5minutes.  Then about eight hours after getting the vaccine I started with body aches, mild headache, and chills which all lasted for five hours - I did take Tylenol ten hours after getting the vaccine, (two hours after the first sign of chills).  When the chills resided I started with thick mucus production and post nasal drip.   Now, 21 hours after getting the vaccine I feel clammy and continue to have mucus production.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Upper-airway cough syndrome
Clinical narrative: After 10 minutes of getting the vaccine I felt mildly light headed, which lasted 5minutes.  Then about eight hours after getting the vaccine I started with body aches, mild headache, and chills which all lasted for five hours - I did take Tylenol ten hours after getting the vaccine, (two hours after the first sign of chills).  When the chills resided I started with thick mucus production and post nasal drip.   Now, 21 hours after getting the vaccine I feel clammy and continue to have mucus production.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Oedema, Oedema peripheral, Pain, Pruritus
Clinical narrative: 7 days after shot developed intense itching in left palm, minimally relieved w steroid cream.itching spread to wrist and back of hand. Both areas  were slightly edematous pitting at the wrist. NO breathing No wheezing or SOB. Minimal help from Benadryl. About 0230 I took 2 naproxen, which helped a lot. As of this am pain redness swelling markedly improved.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: 7 days after shot developed intense itching in left palm, minimally relieved w steroid cream.itching spread to wrist and back of hand. Both areas  were slightly edematous pitting at the wrist. NO breathing No wheezing or SOB. Minimal help from Benadryl. About 0230 I took 2 naproxen, which helped a lot. As of this am pain redness swelling markedly improved.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Oedema, Oedema peripheral, Pain, Pruritus
Clinical narrative: Patient was immunized on 5-1-19 in the left deltoid. She stated that she noticed 5-7-19 that her left hand was very itchy and was swollen (she described as edema). She has tried an anti itch cream that were purchased over the counter but that did not alleviate the itching or swelling. Patient stated she had taken Benadryl later that day to help alleviate the symptoms and that worked. She called the pharmacy on 5-8-19 and requested the lot number of the Shingrix vaccine as she felt the reaction was related to the vaccine. She stated that she felt no pain at the site of injection following the vaccine, and this reaction occurred on her hand on 5-7-19, and she began to describe what she experienced. Patient confirmed on 5-8-19 that swelling and itching had been resolved. When speaking to her on 5-8-19 she said she had no more itching or swelling. She stated she also took a non-steroidal medication ( NSAID ) but did not specify which.
Age: 67.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Patient was immunized on 5-1-19 in the left deltoid. She stated that she noticed 5-7-19 that her left hand was very itchy and was swollen (she described as edema). She has tried an anti itch cream that were purchased over the counter but that did not alleviate the itching or swelling. Patient stated she had taken Benadryl later that day to help alleviate the symptoms and that worked. She called the pharmacy on 5-8-19 and requested the lot number of the Shingrix vaccine as she felt the reaction was related to the vaccine. She stated that she felt no pain at the site of injection following the vaccine, and this reaction occurred on her hand on 5-7-19, and she began to describe what she experienced. Patient confirmed on 5-8-19 that swelling and itching had been resolved. When speaking to her on 5-8-19 she said she had no more itching or swelling. She stated she also took a non-steroidal medication ( NSAID ) but did not specify which.
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Musculoskeletal disorder, Musculoskeletal pain, Nausea
Clinical narrative: Pain at the ball of the shoulder. States cannoT use leFt arm. Nausea
Age: 69.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: Pain at the ball of the shoulder. States cannoT use leFt arm. Nausea
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Mobility decreased
Clinical narrative: Injected site pain; mobility impariment; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In December 2018, the patient received the 2nd dose of Shingrix. On an unknown date, less than a year after receiving Shingrix, the patient experienced injection site pain and mobility decreased. On an unknown date, the outcome of the injection site pain and mobility decreased were unknown.   It was unknown if the reporter considered the injection site pain and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a dose of Shingrix in the left arm. The patient experienced severe sharp pain in the site since. The patient had some mobility impairment as well. Especially painful at night. The patient asked for further suggestions.
Sex: F
Vaccine: VARZOS
Symptoms: Hypersensitivity
Clinical narrative: Allergic reaction around the eyes and chest; This case was reported by a physician via sales rep and described the occurrence of allergic reaction in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix (intramuscular) .5 ml. On an unknown date, less than a week after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient went 2 days after vaccination with shingrix to the doctor with an apparent allergic reaction around the eyes and chest. The reporter agree to follow up with GlaxoSmithKline.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Dyspnoea, Erythema, Feeling hot, Pain in extremity
Clinical narrative: Began as sore arm, redness and heat began then patient started having trouble breathing. Went to walk in Er and received meds to help and given a script of a medrol dose pack.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: PATIENT DEVELOPED REDNESS AT INJECTION SITE. THE RED AREA BECAME INCREASINGLY  WORSE AND STARTED TO ENLARGE.  IT WAS NOT GOING AWAY AFTER SEVERAL DAYS AND THE PATIENT FELT LIKE IT WAS GETTING WORSE AND NOT BETTER.  THE PATIENT VISITED URGENT CARE ON  5-6-19 WHERE SHE WAS DIAGNOSED WITH CELULLITIS AND GIVEN A COURSE OF ANTIBIOTICS.   SHE REPORTS THAT THE SITE IS MUCH IMPROVED AT THIS TIME.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Decreased activity, Dizziness, Headache, Influenza like illness
Clinical narrative: Starting same evening as vaccination, chills, fevers, body aches, lethargy, dizziness. This continued for almost 4 days, and then 2 more days with headache that was one-sided. It took me almost a week to feel better. I was unable to function normally, had to stay home most of the time and felt like I had a flu. I am a healthy person and hardly ever get sick.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Lethargy, Pain, Pyrexia
Clinical narrative: Starting same evening as vaccination, chills, fevers, body aches, lethargy, dizziness. This continued for almost 4 days, and then 2 more days with headache that was one-sided. It took me almost a week to feel better. I was unable to function normally, had to stay home most of the time and felt like I had a flu. I am a healthy person and hardly ever get sick.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Headache, Influenza like illness, Malaise, Myalgia
Clinical narrative: nausea; stomach pain; headache, hives on upper arm near shoulder; muscle aches like flu symptoms; general feeling of illness
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Urticaria
Clinical narrative: nausea; stomach pain; headache, hives on upper arm near shoulder; muscle aches like flu symptoms; general feeling of illness
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Fatigue, Headache, Myalgia, Peripheral swelling
Clinical narrative: Left arm has rash, redness, swollen, warm to touch. Muscle pain/soreness, headache, feeling tired.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Skin warm
Clinical narrative: Left arm has rash, redness, swollen, warm to touch. Muscle pain/soreness, headache, feeling tired.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Injection site discomfort, Myalgia, Pyrexia
Clinical narrative: Soreness at injection site.  Full-body myalgias, arthralgias starting 9 hours after injection; Fever to 100.1 on the morning following injection.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Erythema, Swelling
Clinical narrative: Localized moderate redness/swelling noted 1 day after vaccination; resolving by following day.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Vaccine outdated
Age: 36.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: Pain on the L. arm started 1-2 days after receiving the vaccines, it is not improving and radiates up to her neck and down her arm, has not been seen for evaluation by any medical  personnel, has taken OTC analgesic, and does plan to see her PCP today
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: the patient received M-M-R II intrarnuscularly; no adverse symptoms reported; This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, medical history, concomitant medications and drug reactions or allergies was provided. On an unknown date, the patient was vaccinated with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) (albumin status, lot number, expiration date, dose number and exact dose were not provided) intramuscularly for prophylaxis (incorrect route of product administration). No adverse events reported.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral, Skin induration
Clinical narrative: edema of my feet, ankles, up to both knees; edematous areas red coloured; edematous areas feel hard; This case was reported by a consumer via call center representative and described the occurrence of peripheral edema in a patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included mastectomy (had 1 year before the reporting date, 10 nodes were removed, 2 were positive) and axillary lymphadenectomy. Concomitant products included tramadol.   On 17th April 2019, the patient received the 2nd dose of Shingrix (intramuscular). On 18th April 2019, 1 days after receiving Shingrix, the patient experienced peripheral edema, erythema edematous and skin induration. On an unknown date, the outcome of the peripheral edema, erythema edematous and skin induration were unknown.   It was unknown if the reporter considered the peripheral edema, erythema edematous and skin induration to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient noticed who had edema in both of feet, ankles, up to both knees.  The edematous areas felt hard, not pitted, and red colored.  The only new medicine the patient received late Friday from patients radiation oncologist was tramadol 50 mg, 1 tab Q 4 hours as need.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Dizziness, Dyspnoea, Fatigue, Headache
Clinical narrative: dizziness; tired; soreness chest; breathing problems; headache; This case was reported by a consumer via call center representative and described the occurrence of dizziness in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th April 2019, the patient received the 1st dose of Shingrix. In April 2019, less than a week after receiving Shingrix, the patient experienced tiredness, chest pain, difficulty breathing and headache. On 24th April 2019, the patient experienced dizziness. On an unknown date, the outcome of the dizziness, tiredness, chest pain, difficulty breathing and headache were not recovered/not resolved.   It was unknown if the reporter considered the dizziness, tiredness, chest pain, difficulty breathing and headache to be related to Shingrix.  Additional details were provided as follows: About six hours later, the patient started having dizziness.  He also felt more tired, his chest was sore, problems breathing and headache. The patient consented to follow up.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Allergy test positive, Anaphylactic reaction, Cough, Dyspnoea, Erythema
Clinical narrative: 4 Y female Complex medical h/o with neonatal lung disease, pulmonary hypertension; s/p R AKA after (chart notes indicate) complications following cardiac cath, called after possible anaphylactic reaction on 1/18/2019 resulting in ED visit. On 1/18/19, received two vaccines - DTaP-POL and MMR-VAR; has received similar in past with no problems.  Bandaid was applied.  No obvious latex exposure such as latex tourniquet or gloves / no blood draw that day. No new foods that day.  She was still taking amoxicillin, took a dose around 9:30 AM.  She took more doses after that with no subsequent reactions. Symptoms started as walking out of clinic.   Initially, had ?aspiration-- coughing, shortness of breath, and turned "purple" ; received breathing treatment. O2 sat noted to be 84%. Later, she started turning red.  No individual hives, no lip/eyelid swelling. No vomiting.  +respiratory distress initially as noted and seemed to improve after epi / benadryl in ED.  Overall 2 hours to improvement." Further history is that she had a mild reaction with perioral hives after eating jello as a 1 year old, and the family has been avoiding any jello/gelatin in her diet since that time. Current Treatment:  EPi / benadryl for anaphylaxis action plan Note:Anaphylaxis after MMR-VAR (and DTAP-POL although MMR-VAR was the likely cause).  Skin test positive for the vaccine and for gelatin.  Gelatin is most common cause of MMR-VAR allergy.  Vaccines known to contain gelatin include: MMR, varicella, Japanese encephalitis virus, yellow fever, zoster.  She needs allergy evaluation before any of those vaccines or DTAP-POL.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Skin discolouration
Clinical narrative: 4 Y female Complex medical h/o with neonatal lung disease, pulmonary hypertension; s/p R AKA after (chart notes indicate) complications following cardiac cath, called after possible anaphylactic reaction on 1/18/2019 resulting in ED visit. On 1/18/19, received two vaccines - DTaP-POL and MMR-VAR; has received similar in past with no problems.  Bandaid was applied.  No obvious latex exposure such as latex tourniquet or gloves / no blood draw that day. No new foods that day.  She was still taking amoxicillin, took a dose around 9:30 AM.  She took more doses after that with no subsequent reactions. Symptoms started as walking out of clinic.   Initially, had ?aspiration-- coughing, shortness of breath, and turned "purple" ; received breathing treatment. O2 sat noted to be 84%. Later, she started turning red.  No individual hives, no lip/eyelid swelling. No vomiting.  +respiratory distress initially as noted and seemed to improve after epi / benadryl in ED.  Overall 2 hours to improvement." Further history is that she had a mild reaction with perioral hives after eating jello as a 1 year old, and the family has been avoiding any jello/gelatin in her diet since that time. Current Treatment:  EPi / benadryl for anaphylaxis action plan Note:Anaphylaxis after MMR-VAR (and DTAP-POL although MMR-VAR was the likely cause).  Skin test positive for the vaccine and for gelatin.  Gelatin is most common cause of MMR-VAR allergy.  Vaccines known to contain gelatin include: MMR, varicella, Japanese encephalitis virus, yellow fever, zoster.  She needs allergy evaluation before any of those vaccines or DTAP-POL.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Chiropractic, Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: While administering flu shot, nurse said "it fell apart so I had to push really hard". There was intense, immediate pain in my left arm that was felt all around my humerus bone. Within an hour I could barely lift my arm. By the next day the pain was 9/10 and moving my arm made it worse. I could only move my left arm by manually lifting my left arm with my right hand. The result, at this point - after 7 months is tendonitis and a frozen shoulder. I have had 6 months of physical therapy and chiropractic manipulation with some relief of pain, but my left arm range of motion is still limited and painful.
Age: 47.0
Sex: F
Vaccine: FLUX
Symptoms: Periarthritis, Tendonitis, X-ray
Clinical narrative: While administering flu shot, nurse said "it fell apart so I had to push really hard". There was intense, immediate pain in my left arm that was felt all around my humerus bone. Within an hour I could barely lift my arm. By the next day the pain was 9/10 and moving my arm made it worse. I could only move my left arm by manually lifting my left arm with my right hand. The result, at this point - after 7 months is tendonitis and a frozen shoulder. I have had 6 months of physical therapy and chiropractic manipulation with some relief of pain, but my left arm range of motion is still limited and painful.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Oral herpes
Clinical narrative: Flu-like symptoms for two days, followed by oral fever blisters (underside of tongue and lip)
Age: 0.75
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Injection site warmth, Rash
Clinical narrative: She got the shot at 8:45am, I took her to her babysitters, then picked her up at 6. At 6:30 I was giving her a bath and noticed the right thigh was super swollen(around 3x swollen), red with rash, and warm to the touch. Saturday morning, the 27, she woke up with red spots on her face. They were flush with the skin. By noon a few had shown up on her arms. They were gone Sunday morning. This past weekend, Sunday may 5, and again on Monday May 6, she had what looked to me to be minor seizures.
Age: 0.75
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Rash erythematous, Seizure
Clinical narrative: She got the shot at 8:45am, I took her to her babysitters, then picked her up at 6. At 6:30 I was giving her a bath and noticed the right thigh was super swollen(around 3x swollen), red with rash, and warm to the touch. Saturday morning, the 27, she woke up with red spots on her face. They were flush with the skin. By noon a few had shown up on her arms. They were gone Sunday morning. This past weekend, Sunday may 5, and again on Monday May 6, she had what looked to me to be minor seizures.
Age: 30.0
Sex: M
Vaccine: IPV
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: Patient received Polio vaccine and he is to old for the vaccine. Patient has not experienced any signs or symptoms from the vaccine.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient was vaccinated with improperly stored dose of Varivax; This spontaneous report was received from a physician refers to a 4 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, allergies or concomitant medications.  On 10-JAN-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # R002509 with expiration date on 25-JAN-2020, dose, frequency, route of administration were not reported), The vaccine was reconstitute with properly store sterile diluent (dose, frequency, route of administration, lot number and expiration date were not reported).    Administered dose of vaccine experienced temperature excursion between 6 degrees Fahrenheit up to 14 degrees Fahrenheit (14.2 F) for 3 hours and 15 degrees Fahrenheit up to 46 degrees Fahrenheit (30.6 F) for 2 days, 16 hours and 15 minutes. There was a previous temperature excursion for 6 degrees Fahrenheit up to 14 degrees Fahrenheit (11.3 F) for 7 hours and 20 minutes. Digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1905USA003150: US-009507513-1905USA003151: US-009507513-1905USA003152:
Sex: F
Vaccine: HPV4
Symptoms: Cervix carcinoma stage I
Clinical narrative: This spontaneous report received from a nurse prescriber via company representative referring to a currently 23-year-old female patient. There was no information about the patient's concurrent conditions, concomitant therapies, previous drug reactions, allergies or medical history. Approximately in 2008, when the patient was 12 years old, she received the first two doses of GARDASIL, (dose, route, anatomical location unknown) and her last dose approximately in 2009 when she was 13 years old. On an unknown date, the patient experienced stage 1 cervical cancer. It was reported that the patient sought medical attention but was unknown if any labs diagnostics nor studies were performed. The outcome and the causal relationship between cervical cancer stage I and GARDASIL were unknown. Upon internal review cervical cancer stage I was considered to be a medically significant event.
Sex: F
Vaccine: HPV4
Symptoms: Death
Clinical narrative: This spontaneous report was received from a journalist and refers to unspecified number of female patients of unknown age (reported as young). There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patients were vaccinated with GARDASIL for prophylaxis (dose, route and site of administration, lot number and expiration date were not reported). On unknown dates (reported as follow vaccinations), the patients experienced life-threatening or lethal side effects. The cause o f death was not provided. The outcome of the events was unknown. The relatedness between the events and the GARDASIL was not provided. This is one of several reports received from the same reporter. Sender's Comments: US-009507513-1905USA003023: US-009507513-1905USA003024: US-009507513-1905USA003025: US-009507513-1905USA003113.
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse effects reported; The patient received her third dose of GARDASIL 9 on 03-MAY-2019 however she received the first two doses in March of 2018 and in May of 2018, respectively.; This spontaneous report was received from a nurse and refers to a 27 year old female patient. The patient's concurrent conditions, medical history, drug allergies/reactions and concomitant medications, if any, were not reported.    In March 2018, the patient was vaccinated with the first dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) then in May 2018, with the second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, route of administration, anatomical site of vaccination, lot number and expiration date were not reported) and on 03-MAY-2019 with the third dose hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) 1 dose (route of administration and anatomical site of vaccination were not reported; lot number M037770, expiry date: 01-JUN-2019); all doses administered for prophylaxis (inappropriate schedule of product administration). No adverse effects reported.
Sex: U
Vaccine: MMRV, VARCEL
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effect reported.; the patient (...) was inadvertently administered a dose of PROQUAD (...) and a dose of VARIVAX; pro-rHa This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's concurrent condition, past medical history, concomitant medications and drug reactions or allergies was provided. On 03-MAY-2019, the patient was inadvertently vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) lot # R026350, expiration date 15-MAR-2020, albumin status rHA (recombinant Human albumin) and a dose of varicella virus vaccine live (oka/merck) (VARIVAX) lot # R030485, expiration date 22-OCT-2020 (exact dose and route of administration were not provided for any of the suspect therapies). No adverse effect was reported.
Sex: U
Vaccine: MMR, UNK
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects; patient was  vaccinated with improperly stored MMR II; This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's historical condition, concomitant medications and drug reactions or allergies were not reported.   On 25-FEB-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) lot # R008031 and expiration date 18-MAR-2020 for prophylaxis (dosage schedule, route, and anatomical location were not reported). Other suspect therapy was sterile diluent for prophylaxis (dosage schedule, route, anatomical location, lot number and expiration date were not reported). The administered dose of Measles, Mumps, and Rubella (Wistar RA 27-3) Virus Vaccine, Live (M-M-R II) experienced a temperature excursion above 9 degrees Celsius (8.59 C) for 15 minutes, and for sterile diluent experienced a temperature excursion above 1.18 degrees Celsius for 33 hours, as recorded by a data logger. There was no previous temperature excursion. No adverse effects reported.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-1905USA001733:
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects were reported; the patient, was inadvertently administered an expired dose of MMR II; This spontaneous report was received from a medical assistant referring to a 4 years old patient of unknown gender. Information about concurrent condition, concomitant medication and medical history was not provided.   On 06-MAY-2019, the patient was inadvertently vaccinated with an expired dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (rHA) (M-M-R II) (lot # N013869, expiration date 05-MAY-2019; strength and dose were not reported) subcutaneously for prophylaxis (expired product administered). No adverse events were reported.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient was vaccinated with improperly stored dose of Varivax; This spontaneous report was received from a physician refers to a 4 year old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, allergies or concomitant medications.  On 26-FEB-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # R002509 with expiration date on 25-JAN-2020, dose, frequency, route of administration were not reported), The vaccine was reconstitute with properly store sterile diluent (dose, frequency, route of administration, lot number and expiration date were not reported).    Administered dose of vaccine experienced temperature excursion between 6 degrees Fahrenheit up to 14 degrees Fahrenheit (14.2 F) for 3 hours and 15 degrees Fahrenheit up to 46 degrees Fahrenheit (30.6 F) for 2 days, 16 hours and 15 minutes. There was a previous temperature excursion for 6 degrees Fahrenheit up to 14 degrees Fahrenheit (11.3 F) for 7 hours and 20 minutes. Digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1905USA000487: US-009507513-1905USA003151: US-009507513-1905USA003152:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient was vaccinated with improperly stored dose of Varivax; This spontaneous report was received from a physician refers to a 12 months old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, allergies or concomitant medications.  On 05-FEB-2019, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # R002509 with expiration date on 25-JAN-2020, dose, frequency, route of administration were not reported), The vaccine was reconstitute with properly store sterile diluent (dose, frequency, route of administration, lot number and expiration date were not reported).    Administered dose of vaccine experienced temperature excursion between 6 degrees Fahrenheit up to 14 degrees Fahrenheit (14.2 F) for 3 hours and 15 degrees Fahrenheit up to 46 degrees Fahrenheit (30.6 F) for 2 days, 16 hours and 15 minutes. There was a previous temperature excursion for 6 degrees Fahrenheit up to 14 degrees Fahrenheit (11.3 F) for 7 hours and 20 minutes. Digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1905USA000487: US-009507513-1905USA003150: US-009507513-1905USA003152:
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported.; patient was vaccinated with improperly stored dose of Varivax; This spontaneous report was received from a physician refers to a 12 months old patient of unknown gender. No information was provided regarding the patient's medical history, concurrent conditions, allergies or concomitant medications.  On 27-NOV-2018, the patient was vaccinated with improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) for prophylaxis (lot # R002509 with expiration date on 25-JAN-2020, dose, frequency, route of administration were not reported), The vaccine was reconstituted with properly store sterile diluent (dose, frequency, route of administration, lot number and expiration date were not reported).    Administered dose of vaccine experienced temperature excursion between 6 degrees Fahrenheit up to 14 degrees Fahrenheit (14.2 F) for 3 hours and 15 degrees Fahrenheit up to 46 degrees Fahrenheit (30.6 F) for 2 days, 16 hours and 15 minutes. There was a previous temperature excursion for 6 degrees Fahrenheit up to 14 degrees Fahrenheit (11.3 F) for 7 hours and 20 minutes. Digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1905USA000487: US-009507513-1905USA003150: US-009507513-1905USA003151:
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster
Clinical narrative: shingles/ zoster episode; Vesicle torso; This case was reported by a nurse via sales rep and described the occurrence of herpes zoster in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster (multiple episodes of zoster).   On 26th March 2019, the patient received the 1st dose of Shingrix. On 5th April 2019, 10 days after receiving Shingrix, the patient experienced herpes zoster and vesicles. On an unknown date, the outcome of the herpes zoster and vesicles were recovered/resolved.   It was unknown if the reporter considered the herpes zoster and vesicles to be related to Shingrix.  Additional details were provided as follows: The patient developed minor zoster episode with vesicles torso.  In April 2019, the event resolved within several days.  The reporter gave permission to contact for follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: Sick; This case was reported by a other health professional via sales rep and described the occurrence of sickness in a adult patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group was not reported but it was selected as adult as per the vaccine indication. The patient received 1st dose of Shingrix and was sick. For tolerances of 2nd dose, refer case US2019GSK081721.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: arm swelling; arm red; arm hot; welt; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a adult female patient who received Herpes zoster (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 swelling arm, erythema of extremities, skin warm and welts. On an unknown date, the outcome of the swelling arm, erythema of extremities, skin warm and welts were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, skin warm and welts to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that her arm was swollen, red and very hot following Shingrix. The welt was 6 to 7 inches long. The patient stated that 3 other people she spoke with had the same reaction as her. The patient did not provide any additional information, though she still wanted to be reimbursed for the vaccine. This case has been linked to US2019AMR068938, US2019AMR068954, US2019AMR068953 reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood glucose increased, Erythema, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: arm swelling; arm red; arm hot; welt; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a adult female patient who received Herpes zoster (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 swelling arm, erythema of extremities, skin warm and welts. On an unknown date, the outcome of the swelling arm, erythema of extremities, skin warm and welts were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, skin warm and welts to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that her arm was swollen, red and very hot following Shingrix. The welt was 6 to 7 inches long. The patient stated that 3 other people she spoke with had the same reaction as her. The patient did not provide any additional information, though she still wanted to be reimbursed for the vaccine. This case has been linked to US2019AMR068938, US2019AMR068954, US2019AMR068953 reported by same reporter.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Urticaria
Clinical narrative: arm swelling; arm red; arm hot; welt; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a adult female patient who received Herpes zoster (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 swelling arm, erythema of extremities, skin warm and welts. On an unknown date, the outcome of the swelling arm, erythema of extremities, skin warm and welts were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, skin warm and welts to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter reported that her arm was swollen, red and very hot following Shingrix. The welt was 6 to 7 inches long. The patient stated that 3 other people she spoke with had the same reaction as her. The patient did not provide any additional information, though she still wanted to be reimbursed for the vaccine. This case has been linked to US2019AMR068938, US2019AMR068954, US2019AMR068953 reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm, Urticaria
Clinical narrative: arm swelling; red arm; arm hot; welt; This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a adult patient who received Herpes zoster (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 swelling arm, erythema of extremities, skin warm and welts. On an unknown date, the outcome of the swelling arm, erythema of extremities, skin warm and welts were unknown.   It was unknown if the reporter considered the swelling arm, erythema of extremities, skin warm and welts to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The caller stated that 3 other people she spoke with had the same reaction as her. Following Shingrix the patients arm was swollen, red and very hot. The welt was 6 to 7 inches long. The caller did not provide any additional information, though she still wants to be reimbursed for the vaccine. This case has been linked to US2019AMR068938, US2019AMR068949, US2019AMR068954 reported by same reporter.