chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Feeling abnormal, Headache, Influenza like illness, Malaise
Clinical narrative: Patient did not have any adverse events from the first shot in the series. The following morning after the second dose, she experienced the symptoms we discussed at the time of the shot aches, fever, malaise, and overall not well, described like having the flu. The next day she experience terrible headaches that were on the right side of her head. These pains came in bursts and would switch locations, top of head, side of head and then behind her right eye.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia, SUNCT syndrome
Clinical narrative: Patient did not have any adverse events from the first shot in the series. The following morning after the second dose, she experienced the symptoms we discussed at the time of the shot aches, fever, malaise, and overall not well, described like having the flu. The next day she experience terrible headaches that were on the right side of her head. These pains came in bursts and would switch locations, top of head, side of head and then behind her right eye.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Pain
Clinical narrative: Fatigue, aches, pain at injection site.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Pain, Pyrexia
Clinical narrative: Patient reports chills, fever, aches, and weakness starting 8 hours after vaccination and continuing into the following day.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Immediate post-injection reaction, Injection site pain, Middle insomnia
Clinical narrative: Soreness in arm at injection site immediately after injection. Awakened at 1:30 am approx. 12 hours after injection with chills and fever of 100.1 degrees. Also felt very sore in arms and legs and weak. Fever broke about 6:00 a.m. so far has not returned but I still feel achy and weak and arm is still sore.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Soreness in arm at injection site immediately after injection. Awakened at 1:30 am approx. 12 hours after injection with chills and fever of 100.1 degrees. Also felt very sore in arms and legs and weak. Fever broke about 6:00 a.m. so far has not returned but I still feel achy and weak and arm is still sore.
Age: 65.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: Half dollar size rash with swelling. This appeared the next day around injection site.
Age: 2.0
Sex: F
Vaccine: DT
Symptoms: Condition aggravated, Seizure
Clinical narrative: Patient went into full convulsive seizure for about 15 minutes three days after vaccination given.  Ambulance was called where medication was given to get her out of seizure. She did not come out of it on her own. Ambulance took to ER where she was hospitalized overnight. This was the second seizure reaction to a vaccine. Patient has a history of seizures, and they are triggered by fighting illness in her body.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Discomfort, Erythema, Induration, Musculoskeletal pain
Clinical narrative: Started a couple hours after vaccine administration (approximately 4 hours). Aches from shoulder all the way down to hip; very sore. Arm became very swollen, hard, and red. Felt as if a tourniquet was wrapped around it. The next morning, developed a low grade fever (approximately 100 F).
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Started a couple hours after vaccine administration (approximately 4 hours). Aches from shoulder all the way down to hip; very sore. Arm became very swollen, hard, and red. Felt as if a tourniquet was wrapped around it. The next morning, developed a low grade fever (approximately 100 F).
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary mass, Axillary pain, Injection site irritation, Lymphadenopathy
Clinical narrative: 11/8/2018 1041 AM patient is at work today and is calling to report that she got her flu shot 2 days ago, and now has painful swelling and a "mass" under her armpit/ ? lymph gland. She will stop by Occ Health today for RN to view it. She was advised that will probably need to be seen by PCP to be certain that is the flu shot that caused the reaction. 1315 PM patient in office to be checked. She has a palm size painful lump under left armpit area that is tender when palpated 5/10 pain. It is not hot or red. IM site can be seen with band aide irritation noted to Left deltoid. She did not get vaccine 2 days ago, but got it yesterday between 10a-2p during flu clinic. She reported "good technique" by student who gave vaccine. She is afebrile, and has no other symptoms. Area is marked with sharpie and photo taken with her phone. She will report back here at 10am start of her shift in the morning, and use ice and ibuproifen Q 6-8 hours until seen again. Any changes, she is to go to urgent care this evening. She will have spouse check marked area again this evening. RN also present for assessment. 11/9/2018 1254p Called patient as she did not come to office at 10am as agreed. She reports "not better" She has been using ice and Ibuprofen and it is more tender now. Size as marked has not changed, but she says it woke her up last night when she was turning over in bed. She plans to call her PCP or GYN and be seen. She will report back to Occ Health Monday with verbal report of whether they think this is related to the flu shot or not. She verbalizes that "she has had trouble on this side prior and they have been watching that side before  this happened. She will plan to not take vaccines in this arm in the future.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: Pt was given Hep A early by 2 months. No symptoms, no adverse reaction.
Age: 12.0
Sex: M
Vaccine: HEP
Symptoms: Facial asymmetry, Facial paralysis, Hypoaesthesia
Clinical narrative: BELL'S PALSY RIGHT SIDE FEELING NUMB RIGHT SIDE OF FACE, THEN ASYMMETRY OF FACE FOLLOWED. NO FEVER, NO OTHER SIGNS OF ILLNESS. NO EAR PAIN, NO COUGH, NO COLD. PREDNISONE 50mg 1 TAB DAILY X 5 DAYS THEN 1/2 TAB DAILY X 5 DAYS.
Age: 2.0
Sex: F
Vaccine: HIBV, IPV
Symptoms: Seizure, Somnolence, Staring
Clinical narrative: Patient went into staring seizure, and her parents could not get her out of it. She started to convulse, and an ambulance was called. Patient came out of it on her own when paramedics arrived and was very sleepy. She may have had a mild fever around a 99.
Age: 24.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: 2+ weeks following vaccination, patient reports right arm pain, numbness, tingling, and right hand numbness.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Differential white blood cell count, Full blood count, Injected limb mobility decreased, Pain, Pruritus
Clinical narrative: Pain, fevers, difficulty moving right arm days 1-2 after receiving vaccine followed by localized swelling, hives and itching of right arm treated with oral antibiotics starting 11/3/18 by clinic for concern of cellulitis treated with oral antihistamines, NSAID's and acetaminophen by clinic and our office for pain, fevers, itching and hives.
Age: 42.0
Sex: F
Vaccine: FLU4, PPV, TDAP
Symptoms: Pyrexia, Swelling, Urticaria
Clinical narrative: Pain, fevers, difficulty moving right arm days 1-2 after receiving vaccine followed by localized swelling, hives and itching of right arm treated with oral antibiotics starting 11/3/18 by clinic for concern of cellulitis treated with oral antihistamines, NSAID's and acetaminophen by clinic and our office for pain, fevers, itching and hives.
Age: 25.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Malaise, Nausea, Pyrexia, Vomiting
Clinical narrative: Fever to 102, nausea, vomiting and malaise beginning within 12 hours of vaccine. One episode of vomiting only thus far. Fever currently is 101 (24 hours later).
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of influenza-like symptoms in a male patient who received SHINGRIX for prophylaxis. In July 2018, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was recovered/resolved. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: This case was reported by the physician for himself. The age at vaccination was not reported. The patient experienced flu like symptoms which impacted him for a few days. Due to what the patient experienced, he was not sure that he would be receiving the second dose of SHINGRIX and if he could be received, it would be a while. The patient did not agree to be followed up. This is 1 of the 6 cases reported by same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of vaccination failure in a adult patient who received SHINGRIX for prophylaxis. Co-suspect products included SHUNGRIX for prophylaxis. The patient's past medical history included shingles (mild breakout of shingles on my forearm). Previously administered products included Radiation therapy. Concurrent medical conditions included lung cancer metastatic and immunocompromised (immune resistance was probably compromised). In April 2018, the patient received the 1st dose of SHINGRIX. In May 2018, the patient received the 2nd dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX and SHINGRIX, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.  It was unknown if the reporter considered the vaccination failure and shingles to be related to SHINGRIX and 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 vaccine indication. The patient previously had a mild breakout of shingles on forearm. The patient's immune resistance was probably compromised at the time as the patient was in radiation treatment for cancer; primary lung cancer with metastases. At the time of reporting, the patient was in remission. Since the past two weeks from the date of reporting (in 2018), the patient had a re-occurrence of Shingles on the same forearm. This case was considered as suspected vaccination failure, since the details regarding time to onset for shingles and lab test confirmation of shingles was not provided. The patient was asking if it was possible or advisable to be re-vaccinated with SHINGRIX.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth, Product storage error
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site erythema in a 80-year-old female patient who received SHINGRIX (batch number D294J, expiry date 22nd March 2021) for prophylaxis. On 2nd November 2018, the patient received the 1st dose of SHINGRIX. In November 2018, less than a week after receiving SHINGRIX, the patient experienced injection site erythema and injection site warmth. On an unknown date, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the injection site erythema, injection site warmth and incorrect storage of drug were unknown. It was unknown if the reporter considered the injection site erythema and injection site warmth to be related to SHINGRIX. Additional details were provided as follows: The patient reported that she was able to locate her dose of SHINGRIX at a pharmacy that did not actually give the vaccines. The patient noted it was a hospital pharmacy. The patient did not know the vaccine needed to be refrigerated, and it was out of recommended storage for about a week, which led to incorrect storage of drug. The patient took it to her physician office and the nurse there gave her the vaccination on left arm. The patient stated that, she had a 3 inch circular pale red area of warmth at the injection site.
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Impaired work ability, Pain in extremity, Peripheral swelling
Clinical narrative: This is a spontaneous report received from a contactable Nurse via Pfizer sales representative. This female Nurse (reporting for herself) reported that a female patient of unspecified age received PREVNAR 13, via an unspecified route of administration from an unspecified date at single dose for immunisation. The patient's medical history and concomitant medications were not reported. It was reported that she experienced hurt arm, swelled up and it was red and it hurt her for almost a week and she had to stay home from work because of it. Outcome of the events was unknown.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Back pain, Burning sensation, Gait disturbance, Gait inability, Pain
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for her husband. A male patient of an unspecified age received PREVNAR 13 on 23Oct2018 at single dose for immunisation and a flu shot (influenza vaccine) on 23Oct2018 for immunisation. The patient medical history and concomitant medications were not reported. On 24Oct2018 patient started having lower back pain and then it progressed to where he could not even hardly walk: he had pain, burning, shooting pain down the back of his legs and he could not walk. On 29Oct2018 the ambulance was called and patient went to the hospital. Patient was hospitalized on 29Oct2018 due to the events. He was checked for everything and anything and just the pain was 'surrounded': he was given steroidal injection, a pain injection, a narcotic pain reliever and a steroid injection. He saw a neurosurgeon who did not really see a reason why he would have such severe reactions like this burning, shooting pain down the back of his legs; it was getting progressively worse and before this he was absolutely fine, no problems whatsoever and he has gotten to the point now where he had to use two canes to lean on just in order to walk, when he tried to get out of the house. The final outcome of the events was unknown. Information on the batch number has been requested.
Sex: M
Vaccine: FLUX, PNC13
Symptoms: Pain in extremity, Walking aid user
Clinical narrative: This is a spontaneous report from a contactable consumer who reported for her husband. A male patient of an unspecified age received PREVNAR 13 on 23Oct2018 at single dose for immunisation and a flu shot (influenza vaccine) on 23Oct2018 for immunisation. The patient medical history and concomitant medications were not reported. On 24Oct2018 patient started having lower back pain and then it progressed to where he could not even hardly walk: he had pain, burning, shooting pain down the back of his legs and he could not walk. On 29Oct2018 the ambulance was called and patient went to the hospital. Patient was hospitalized on 29Oct2018 due to the events. He was checked for everything and anything and just the pain was 'surrounded': he was given steroidal injection, a pain injection, a narcotic pain reliever and a steroid injection. He saw a neurosurgeon who did not really see a reason why he would have such severe reactions like this burning, shooting pain down the back of his legs; it was getting progressively worse and before this he was absolutely fine, no problems whatsoever and he has gotten to the point now where he had to use two canes to lean on just in order to walk, when he tried to get out of the house. The final outcome of the events was unknown. Information on the batch number has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Injection site cellulitis, Injection site erythema, Product administered at inappropriate site
Clinical narrative: This is a spontaneous report received from a contactable pharmacist. A patient of unspecified age and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunisation. The patient's medical history and concomitant medications were not reported. On an unspecified date, it was reported that the patient was vaccinated incorrectly with pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) as it did not go into the deltoid muscle. The patient has redness at the injection site and upon consulting with her physician, she was told that she had cellulitis as a result of the injection not being given in the muscle. The outcome of the events was unknown.  Information on the batch number has been requested.; Sender's Comments: Based on the information currently available, the wrong technique in PREVNAR 13 administration might have played a contributory role in triggering the development of redness and cellulitis at vaccination site considering the close time association.  The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Sex: F
Vaccine: PNC13
Symptoms: Cough, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself from a Pfizer-sponsored program. A 63-year-old female patient received the 1st dose of PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for pneumonia, immunisation. Medical history included: in 2009, she was diagnosed with post inflammatory fibrosis because of all the scar tissue in her lungs from the double pneumonia), pneumonia 2 years before (she got the shot for pneumonia), chronic obstructive pulmonary disease, chills, then fever, sweat, and chills hit me out of nowhere, pyrexia, her boyfriend broke into her house and called an ambulance when he found her unconscious, they took her to the hospital where she was given 48 hours to live, but was in a coma for a month and a half, she still struggle with short term memory loss. The patient's concomitant medications were not reported. The patient was feeling sick requiring hospitalization on an unspecified date. It was further reported that two years before this report, she got the shot for pneumonia. Then last year, her grandson visited. And she told them not to bring him if he was sick. He was fine during the day, but then he spent all Saturday night coughing on me. On Sunday, she felt ok while she ran errands, but by evening she was feeling sick. On Monday, she went to the hospital where she stayed for 4 days. The outcome of the event was unknown. Information on the batch number has been requested.
Sex: F
Vaccine: MEN
Symptoms: Rash erythematous, Rash generalised, Streptococcal infection, Vaccination site reaction
Clinical narrative: My daughter got her updated shots for school this year. Among the vaccines was a meningitis vaccine. After the vaccine, on the vaccine site, a large red saucer size rash appeared. This rash grew larger for a week then went away. It's been quite some time since the vaccine. Now my daughter has red bumps that appear all over her body, similar to the original red bumps, rash from the vaccine. These red bumps appear all over her body daily, then go away. Patient is on an antibiotic for strep. These red bumps went completely away with twenty four hours of starting antibiotics, then started reappearing, but only one or two now, while she's on the clindamycin, 150 mg, twice daily for ten days.
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Chills, Diarrhoea, Feeding disorder, Hyperhidrosis
Clinical narrative: Received 50mcg dose of SHINGRIX vaccine. 12h later developed severe chills, sweating, at 36hrs developed SEVERE abdominal cramping and explosive diarrhea, sweating and nausea. Left deltoid where administered there is a large 3 inch erythematous raised wheal which is warm and very tender to the touch 3 days after the injection thus far. The cramping continued on/off for the next two days thus far. I have not been able to eat for two days, eventually took down sips of water and cracker. I am very healthy 56 y.o. male and cannot imagine anyone with compromised health surviving this vaccine. I am amazed the FDA allows this vaccine to be administered. Go get it and see how you feel!!
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site urticaria, Injection site warmth, Nausea
Clinical narrative: Received 50mcg dose of SHINGRIX vaccine. 12h later developed severe chills, sweating, at 36hrs developed SEVERE abdominal cramping and explosive diarrhea, sweating and nausea. Left deltoid where administered there is a large 3 inch erythematous raised wheal which is warm and very tender to the touch 3 days after the injection thus far. The cramping continued on/off for the next two days thus far. I have not been able to eat for two days, eventually took down sips of water and cracker. I am very healthy 56 y.o. male and cannot imagine anyone with compromised health surviving this vaccine. I am amazed the FDA allows this vaccine to be administered. Go get it and see how you feel!!
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Blood pressure decreased, Chills, Decreased appetite, Dehydration
Clinical narrative: Received 50mcg dose of SHINGRIX vaccine. 12h later developed severe chills, sweating, at 36hrs developed SEVERE abdominal cramping and explosive diarrhea, sweating and nausea. Left deltoid where administered there is a large 3 inch erythematous raised wheal which is warm and very tender to the touch 3 days after the injection thus far. The cramping continued on/off for the next two days thus far. I have not been able to eat for two days, eventually took down sips of water and cracker. I am very healthy 56 y.o. male and cannot imagine anyone with compromised health surviving this vaccine. I am amazed the FDA allows this vaccine to be administered. Go get it and see how you feel!!
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Diarrhoea, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Received 50mcg dose of SHINGRIX vaccine. 12h later developed severe chills, sweating, at 36hrs developed SEVERE abdominal cramping and explosive diarrhea, sweating and nausea. Left deltoid where administered there is a large 3 inch erythematous raised wheal which is warm and very tender to the touch 3 days after the injection thus far. The cramping continued on/off for the next two days thus far. I have not been able to eat for two days, eventually took down sips of water and cracker. I am very healthy 56 y.o. male and cannot imagine anyone with compromised health surviving this vaccine. I am amazed the FDA allows this vaccine to be administered. Go get it and see how you feel!!
Age: 56.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth
Clinical narrative: Received 50mcg dose of SHINGRIX vaccine. 12h later developed severe chills, sweating, at 36hrs developed SEVERE abdominal cramping and explosive diarrhea, sweating and nausea. Left deltoid where administered there is a large 3 inch erythematous raised wheal which is warm and very tender to the touch 3 days after the injection thus far. The cramping continued on/off for the next two days thus far. I have not been able to eat for two days, eventually took down sips of water and cracker. I am very healthy 56 y.o. male and cannot imagine anyone with compromised health surviving this vaccine. I am amazed the FDA allows this vaccine to be administered. Go get it and see how you feel!!
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pruritus, Rash
Clinical narrative: Pt. received flu vaccine and immediately had itchy feeling. Noticed rash to forehead/eyelids and neck the following day.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Immediate post-injection reaction, Injection site pain, Urticaria
Clinical narrative: Immediately following vaccination she had a pain in her arm. 2 1/2 weeks later saw MD and was started on Naproxen. Was told by MD that the injection may have burst her Bursa and would need an MRI. Reported her pain to TW 1 month after injection and was instructed to try ibuprofen, ice and rest of the arm x 3-4 days. 1 1/2 months later spoke to participant and she reported that she had broke out in hives and was started on a steroid. At that time the pain in her arm subsided but is now back but the pain is dull. Instructed to notify MD if the pain gets worse. Will continue to follow-up.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Diarrhoea, Fatigue, Headache, Nasal congestion
Clinical narrative: Severe nausea, intense headache, full body ache, diarrhea, fatigue, cough and stuffiness.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Pain
Clinical narrative: Severe nausea, intense headache, full body ache, diarrhea, fatigue, cough and stuffiness.
Age: 32.0
Sex: F
Vaccine: HEPAB
Symptoms: No adverse event
Clinical narrative: As I wiped client's left arm off with alcohol, she started to lean to the right and said that she was going to pass out. I stopped what I was doing and supported her in a seated position in the chair and called for assistance. The cot was immediately brought into the workup room and fellow Imms Nurse helped me stand-by assist her to lie down on the cot. The client was able to support herself the entire time she was standing. We elevated her feet. She was able to hold conversation and never lost consciousness. While she was lying down we discussed some incidents that she has had in the past. She states that she "had seizures all through college but it's been a long time". I asked when she last remembers having a seizure and she said that she had one as recently as one month ago "after doing a cardio workout". She said that she lost consciousness with her arms and legs "flailing" at the gym, "but I could hear everybody talking to me the whole time". There apparently was a nurse who witnessed this event and told her to see a cardiologist because her "pulse would stop for 5-10 seconds then speed up real fast", with this cycle repeating. She states that she did see a cardiologist and wore a Holter Monitor last week and that "they couldn't find anything...no pulse issues on the monitor". Cardiology said that she doesn't need follow-up with them. I inquired about the seizures during her college years and she said that she was taken to the ER each time but they "couldn't figure out why", just that she'd had a seizure and to come back if it happened again. She continued explaining that she can "always taste when this is going to happen...like there's a metal taste in my mouth and I know its coming". I asked if she had that taste now and she stated that she had it right as I wiped her arm off and it lasted until we gave her juice (so for about 10 minutes during today's visit). I administered her TWINRIX injection while she was lying on the cot. She remained talkative and even put her feet up on the counter of the workup room. She tolerated the shot without further incident and brought herself to a seated position on the cot within two minutes of getting the shot. After sitting there for about a minute she stood on her own and walked to the chair. I had her sit there for 2-3 minutes and checked her BP 100/60, pulse regular and strong at 88 bpm. She denied having the "metallic taste" in her mouth and stated that she was "OK to leave", but that she planned to sit in her car for about 10-15 minutes before driving home. She surmises that these episodes are brought on by stress and states that she's been diagnosed with seizures as well as vasovagal syndrome. She did not write any diagnoses nor history on her consent form today or previous consents from this year. She left in stable condition at 16:05.
Age: 51.0
Sex: F
Vaccine: FLUR4
Symptoms: Anaphylactic reaction, Pharyngeal oedema
Clinical narrative: Swelling of the throat - anaphylactic response.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Chest discomfort, Chest pain, Dyspnoea, Limb discomfort, Muscular weakness
Clinical narrative: About 4-5 hours later, spiked low grade fever, she felt SOB, chest heaviness, right arm heaviness, swelling and weakness. She traveled via ambulance and admitted for 7 days Symptoms: FEVER, UNSPECIFIED, CHEST PAIN, UNSPECIFIED.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: About 4-5 hours later, spiked low grade fever, she felt SOB, chest heaviness, right arm heaviness, swelling and weakness. She traveled via ambulance and admitted for 7 days Symptoms: FEVER, UNSPECIFIED, CHEST PAIN, UNSPECIFIED.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Balance disorder, Hyperaesthesia, Hypoaesthesia, Neuralgia
Clinical narrative: Patient developed numbness, weakness, imbalance, urinary frequency and neuropathic pain suggestive of transvere myelitis.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging spinal normal, Pollakiuria
Clinical narrative: Patient developed numbness, weakness, imbalance, urinary frequency and neuropathic pain suggestive of transvere myelitis.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Chills, Erythema, Headache, Influenza like illness, Nasopharyngitis
Clinical narrative: 2 inch circular, eryhthematous lesion with serous fluid initially. Flu-like symptoms (cold, chills, feverish, headache) for 2 days.
Age: 32.0
Sex: M
Vaccine: ANTH
Symptoms: Pyrexia, Secretion discharge, Skin lesion
Clinical narrative: 2 inch circular, eryhthematous lesion with serous fluid initially. Flu-like symptoms (cold, chills, feverish, headache) for 2 days.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient states the patient is radiating down her left arm to the hand. Patient states that the pain began the day following the injection. Patient has taken TYLENOL however has not felt any relief.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Mass, Pain, Swelling
Clinical narrative: Swelling, redness, hard red lump, sore.
Age: 77.0
Sex: U
Vaccine: FLU3
Symptoms: Allergy test negative, Blood glucose increased, Lip swelling, Metabolic function test normal, Peripheral swelling
Clinical narrative: High-density hives everywhere on body below neck; swollen hands, feet, lips; partially constricted throat. Symptoms began evening 10/19/2018. Visited urgent care 10/20 at 10 AM. MD at urgent care issued diagnosis Urticaria, Rx Prednisone. Rx began immediately. NOTE: Cannot input manufacturer in item 17. Sanofi Pasteur/GSK.
Age: 77.0
Sex: U
Vaccine: FLU3
Symptoms: Throat tightness, Urticaria
Clinical narrative: High-density hives everywhere on body below neck; swollen hands, feet, lips; partially constricted throat. Symptoms began evening 10/19/2018. Visited urgent care 10/20 at 10 AM. MD at urgent care issued diagnosis Urticaria, Rx Prednisone. Rx began immediately. NOTE: Cannot input manufacturer in item 17. Sanofi Pasteur/GSK.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Fatigue, Hot flush, Malaise, Pain
Clinical narrative: Extreme vomiting, extreme chills and hot flashes, stabbing jaw pain, all for 24 hours, then body aches, fatigue and feeling crummy for the next week.
Age: 64.0
Sex: F
Vaccine: UNK
Symptoms: Pain in jaw, Vomiting
Clinical narrative: Extreme vomiting, extreme chills and hot flashes, stabbing jaw pain, all for 24 hours, then body aches, fatigue and feeling crummy for the next week.
Age: 33.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Hypersensitivity, Pruritus
Clinical narrative: PT'S FIRST TIME GETTING THE SHOT, SHE HAD A SLIGHT ALLERGIC REACTION. LEFT EAR GOT RED AND ITCHY...SHE SAYS THAT WHEN SHE GETS HER ALLERGY SHOTS THAT SOMETIMES DOES HAPPEN. I ASKED HER IF SHE WANTED BENADRYL, SHE SAID HER ALLERGY DOC USUALLY GIVES HER LORATADINE. SHE SAID SHE ALSO HAS EXTRA PREDNISONE ON HAND AND SHE WOULD GO HOME TO TAKE THAT AS WELL. SHE WAS OK DRIVING HOME BY HERSELF AND I TOLD HER WE WOULD DOCUMENT ON VAERS.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Heart rate increased, Myalgia, Nausea, Pain
Clinical narrative: High heart rate - 125 beats per minute; Body/muscle aches; Fever - 101 degrees; Nausea; Headache.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: High heart rate - 125 beats per minute; Body/muscle aches; Fever - 101 degrees; Nausea; Headache.
Age: 42.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Injection site pain, Skin warm
Clinical narrative: Patient had an erythemic area on her right arm. It was warm to touch and patient complained of pain to the site.
Age: 26.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Patient had an erythemic area noted on her left arm. She complained of the site itching. The site was warm to touch.
Age: 8.0
Sex: M
Vaccine: TD
Symptoms: Dyskinesia, Eyelid function disorder, Facial paralysis
Clinical narrative: Partial facial paralysis. He is unable to open his mouth and eyes fully.
Age: 22.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Erythema, Injection site induration
Clinical narrative: Local erythema up to about 10 cm, small induration at the center for each injection.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt has redness, swelling, hot to touch, approx 8 inches below the site wrapping around the site of injection per Medical staff at Clinic.
Age: 21.0
Sex: M
Vaccine: SMALL
Symptoms: Electrocardiogram ST segment elevation, Myocarditis, Troponin I increased
Clinical narrative: Myopericarditis.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Facial rash.
Age: 73.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient states the area of the injection is red and swollen as large as a baseball and is painful. Advised patient to follow-up with his primary care physician.
Age: 0.33
Sex: M
Vaccine: HIBV, IPV, PNC13, RV5, TDAP
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse events/reactions. Patient was given the wrong dose and was suppose to receive DTaP and was administered Tdap (ADACEL).
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation
Clinical narrative: Redness and inflammation around the injection site.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt complained of severe pain in deltoid and shoulder area. She had trouble lifting arm.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Asthenia, Chills, Hyperhidrosis, Malaise
Clinical narrative: Patient called today and states that around 7pm last night, 4 hours post vaccination, she started to feel ill. She reports chills/aches/feverish/sweating and overall body aches. She reports joint and muscle ache over her entire body. She states that she did not take her temperature as she did not have the strength to find her thermometer. She reports taking ibuprofen for her symptoms and resting.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Patient called today and states that around 7pm last night, 4 hours post vaccination, she started to feel ill. She reports chills/aches/feverish/sweating and overall body aches. She reports joint and muscle ache over her entire body. She states that she did not take her temperature as she did not have the strength to find her thermometer. She reports taking ibuprofen for her symptoms and resting.
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: RED, SWOLLEN, WARM TO TOUCH.
Age: 78.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased
Clinical narrative: Trouble lifting arm post shot.
Age: 10.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness
Clinical narrative: PASSED OUT AFTER INJECTION.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Dizziness, Dyspnoea, Heart rate increased, Hypertension, Pruritus
Clinical narrative: Rash all over body, could not breath, high blood pressure, fast heart rate, itching skin, dizzy.
Age: 22.0
Sex: M
Vaccine: ANTH
Symptoms: Rash generalised
Clinical narrative: Rash all over body, could not breath, high blood pressure, fast heart rate, itching skin, dizzy.
Age: 16.0
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of product administration, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist  and refers to a male patient of an unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. Approximately in 2017 (reported as "over 1 year ago") when he was 16 years old the patient was vaccinated with his first dose of GARDASIL 9 (dose, route, lot # and vaccination site were not provided), for prophylaxis. Now, the patient would like to receive the second dose. No adverse symptoms reported. No product quality complaint was reported.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Drooling, Vomiting
Clinical narrative: This spontaneous report was received from a pharmacist that was also de father of the patient, and refers to a 9 week old male patient. At age 4 weeks, the patient started a intolerance to milk products and was switched to formula with lower lactose a week ago. Before vaccination the patient took acetaminophen. On 06-NOV-2018,  the patient was vaccinated with ROTATEQ, oral for prophylaxis (dose, lot number and expiration date were not reported). On 07-NOV-2018, the patient experienced an increase drooling and vomited a couple times. No treatment was given and no overdose. At the time of report, the outcome of vomiting and drooling was reported as not recovered/not resolved. The causal relationship between the aforementioned events and vaccination with ROTATEQ was not reported.
Sex: M
Vaccine: VARZOS
Symptoms: Cranial nerve palsies multiple, Diplopia, Facial paralysis
Clinical narrative: This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a male patient of unknown age. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or around 28-JUL-2016, the patient was inoculated with ZOSTAVAX for routine health maintenance and for its intended purpose: the prevention of shingles (dose, route, and lot # not provided). Shortly after receiving ZOSTAVAX (exact onset date not further specified), the patient suffered from cranial nerve palsies in the sixth and seventh cranial nerves and lateral rectus palsy in the left eye and was diagnosed with binocular diplopia. In addition, the patient suffered from facial paralysis and was diagnosed with Bell's palsy. As a direct and proximate result of ZOSTAVAX, the patient's symptoms resulted in physical limitations not present prior to using the product. The patient also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of ZOSTAVAX, the patient suffered severe and permanent personal injuries. Further, as a tragic consequence of the Company's wrongful conduct, 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 not recovered/not resolved. Causality assessment was related. Upon internal review, Bell's palsy/cranial nerve palsy in the seventh cranial nerve and cranial nerve palsy in the sixth cranial nerve/lateral rectus palsy in the left eye were considered to be medically significant events. Bell's palsy/cranial nerve palsy in the seventh cranial nerve, cranial nerve palsy in the sixth cranial nerve/lateral rectus palsy in the left eye, and binocular palsy were considered to be disabling.
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a patient of unknown demographics who was vaccinated with a dose of ADACEL (lot number, expiry date was not reported) on an unknown date via subcutaneous route. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. It was a case of actual medication error due to inappropriate route of vaccination. It is not known whether the patient had any untoward experiences after administration. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4
Symptoms: Expired product administered
Clinical narrative: Initial information received on 06-Nov-2018 regarding an unsolicited valid non-serious case received from a consumer (Office Staff). This case involves a six months old female patient who was vaccinated with a 0.5 ml dose of PENTACEL (route: intramuscular, site of administration: thigh NOS, batch number: DTap vial lot # C5020BA exp 6/30/2018 NDC: 49281-560-05 ACTHIB vial lot: C5384AA exp 6/30/2018 NDC: 49281-545-15) on 30-OCT-2018. Concomitant vaccination included FLUZONE QUADRIVALENT (route: intramuscular, site of administration: thigh NOS, batch number and expiration date was not reported) on 30-OCT-2018. The patients medical history were not reported. It was an actual medication error due to expired vaccine used (administered expired pentacel to a female patient). It was unknown whether patient experienced any adverse event following vaccination. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: Body aches, headache, fever of 100 F. This was the second dosage. These symptoms all occurred in the first dosage, too.
Age: 12.0
Sex: M
Vaccine: FLUC4
Symptoms: Lip swelling, Swelling face
Clinical narrative: SWOLLEN LIPS AND FACE.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal stiffness, Neck pain
Clinical narrative: Pt presented with soreness and stiffness of neck and lower back of head.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain in extremity
Clinical narrative: After going to bed I had severe chills. My whole body was shivering. I had to put on extra blankets and heavy socks to counter the chills. I also experienced soreness in the arm. On the day after the shot I had some nausea. This was alleviated by eating. I also took 2 ibuprofen to alleviate headache pain.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient reported on 11-09-18 that her arm still is hurting from the shot she received on 10-12-18.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: The patient received the vaccination on 9/30/18 by pharmacist. The shot was administered in the left deltoid, 2-3 fingers width below the top of the shoulder. The patient was seated with her arm at her side. Patient reported to the pharmacy on 11/10 that since receiving the flu shot in her left arm she has experienced left arm pain. The pt stated the pain started a couple days after the shot. The pain is located in the left arm and radiates up to the neck/collarbones. Pt reported a painful spot on her arm. The pharmacist, palpated pt's arm on 11/10, and pt reported a tender spot approximately 2-3 fingers width below the edge of the shoulder. When speaking to the patient on the phone on 11/11, patient reported to the pharmacist that the pain makes it difficult for the patient to elevate her arm. When asked to measure the location of the tender spot of the left arm, pt stated it was 2 fingers width below the shoulder. The patient has informed her doctor of the pain. The patient has tried using ICY HOT and ibuprofen but states it does not help the pain. As of 11/11 the patient states she thinks the pain is getting better but it is still present.
Age: 2.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse reaction. Patient received 0.5 ml dose. Recommended dose for patient this age for AFLURIA QUAD is 0.25 ml.
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: Patient presented (5 days later) saying that he experienced swelling down the left arm and some pain. Arm is still a little sore but is much better now.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site mass, Injection site swelling
Clinical narrative: Swelling redness lump to site.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site oedema, Injection site pain, Joint stiffness, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Employee complains of pain and stiffness in left shoulder joint that did not resolve after one month after receiving flu vaccine injection. She stated she is concerned it was administered too high. Symptoms not relieved with home care of alternating heat and ice to affected area, rest, and taking usual over the counter pain medications.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Injection site pain, Musculoskeletal pain, Neck pain, Pain
Clinical narrative: Patient came to complain of ongoing pain from PREVNAR injection on 10/8/18. She complained of normal soreness at injection site day after injection. Self-treated with ice but soreness continued. She states that the pain radiated to the shoulder and up to the neck. She says that applying ice helps but that the problem has not gone away. She came into the grocery store to shop and decided to notify the pharmacy on 11/12/18. She says she will follow up with her primary care physician. This was the first time we were told of her pain. She is not completely sure that the pain in shoulder and neck are a result of the vaccine, but the symptoms started after receiving the vaccination.
Age: 43.0
Sex: M
Vaccine: HEPA
Symptoms: Angiogram normal, Computerised tomogram head, Fall, Laboratory test, Subarachnoid haemorrhage
Clinical narrative: Sudden onset of syncope and fall with finding of subarachnoid hemorrhage and subdural hematoma without significant head trauma found, findings inconclusive for reason of the syncope. Negative CTA head and neck.
Age: 43.0
Sex: M
Vaccine: HEPA
Symptoms: Subdural haematoma, Syncope
Clinical narrative: Sudden onset of syncope and fall with finding of subarachnoid hemorrhage and subdural hematoma without significant head trauma found, findings inconclusive for reason of the syncope. Negative CTA head and neck.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Vaccination site cellulitis
Clinical narrative: Cellulitis at site of the vaccination.