chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Injection site warmth, Myalgia, Nausea, Vomiting
Clinical narrative: 5/30/2018: 2 am chills, 8 am nausea, muscle pain, tiredness, dizzy, throwing up, warmth, redness and swelling at injection site, very sore to the touch. After throwing up at 9am I felt a little better, continued to feel better as day went on...there is still redness, pain on touch, warmth and swelling at injection site 3 days later- 6/2/18.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Emotional distress, Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient is complaining of severe pain to the deltoid/upper left arm that started the day after receiving the shot. Patient has sharp painful attacks. Patient having trouble moving arm. She seems very distressed. It has been 3 weeks after shot.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain lower, Abdominal pain upper, Cough, Gastrooesophageal reflux disease, Swelling face
Clinical narrative: Patient experienced lower abdominal pain about 1 week after 2nd dose of SHINGRIX. The abdominal pain subsided and a new pain in the stomach area began ("similar to peptic ulcer"). This turned into extreme acid reflux. The patient then experienced painful coughing. Finally, the patient's left side of face had swelled with a toothache for the past week. Currently, his dentist prescribed PENICILLIN VK, ibuprofen and acetaminophen. All of these symptoms occurred over the course of 3 weeks (5/8/18-6/1/18).
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Toothache, X-ray dental abnormal
Clinical narrative: Patient experienced lower abdominal pain about 1 week after 2nd dose of SHINGRIX. The abdominal pain subsided and a new pain in the stomach area began ("similar to peptic ulcer"). This turned into extreme acid reflux. The patient then experienced painful coughing. Finally, the patient's left side of face had swelled with a toothache for the past week. Currently, his dentist prescribed PENICILLIN VK, ibuprofen and acetaminophen. All of these symptoms occurred over the course of 3 weeks (5/8/18-6/1/18).
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia, Skin discolouration
Clinical narrative: The patient described having black and blue arm, with severe fever and chills for 3 days.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Headache, Lethargy, Myalgia
Clinical narrative: Here's what I know about the vaccine: SHINGRIX, zoster vacc recombinant adjuvanted IM inj. I have a headache, muscle and joint aches, and lethargy.
Age: 90.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Feeling abnormal, Pain in extremity
Clinical narrative: The next day she said her left arm hurt really bad, more than she was expecting and she felt under the weather.
Age: 55.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Feeling hot, Injection site mass, Skin warm, Swelling
Clinical narrative: Patient developed a golf ball sized lump at the injection site of the BOOSTRIX (right arm); she reported redness, swelling and heat/warmth.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, VARZOS, TDAP, VARZOS
Symptoms: Erythema, Pyrexia, Skin warm, Swelling
Clinical narrative: FEVER, REDNESS, SWELLING AND HOT TO TOUCH.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, VARZOS, TDAP, VARZOS
Symptoms: Injection site pain, Injection site warmth, Product quality issue, Pyrexia
Clinical narrative: FEVER, REDNESS, SWELLING AND HOT TO TOUCH.
Age: 0.08
Sex: M
Vaccine: 6VAX-F, PNC13, RV1
Symptoms: Diarrhoea, Gastrooesophageal reflux disease, Head banging, Screaming
Clinical narrative: Our son started with extreme liquid diarrhea and reflux with unrelenting and inconsolable screaming. The diarrhea started first, but by day 6 my son would not stop screaming. Nothing could help to settle him down (breastfeeding, cuddling, rocking, etc.) I had him vaccinated further, because I did not think that this could be a possibilty, but on subsequent vaccines his symptoms became more pronounced more screaming (I walked him 14 miles a day for multiple naps so that he could sleep). He started hitting his head at 5 months, throwing it in all directions and the screaming was unbearable.
Age: 54.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Dizziness, Flushing
Clinical narrative: Patient experienced severe lightheadedness and flushing w/i a few minutes of administration of the two vaccines. She believes she may have momentarily passed out on the table on which she was resting her head. Her vital signs were stable per EMS (evaluated about 20 mins after onset of symptoms). Patient refused transport or further medical care, proceeded to shop in the store, and did return to the pharmacy about 20 min later to report that she felt fine at that time.
Age: 68.0
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema
Clinical narrative: Redness at injection site and move toward elbow and underneath arms (no pain, no fever, no numbness, no itching). Started 2 days post injection. Patient went to urgent care 9/26/18. She was prescribed prednisone 20mg (2 tablets daily with food) for 5 days. Pt has finished treatment and reaction has resolved. (Pt didn't get blood test to see what she had RXN to).
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema, Injection site swelling
Clinical narrative: Pt presents with c/o redness and swelling at SHINGRIX injection site on left shoulder. Denies pain/SOB/CP/dyspnea/tightening of airway/lightheadedness/fatigue. Pt reports reaction appeared 1 day after receiving SHINGRIX vaccine. Pt has been applying a warm compress. Denies decrease in size. Denies spreading or enlarging of symptoms. Pt is A and O x4.  No signs of acute distress.  Afebrile. Circular erythematic edema on left deltoid circumferencing vaccine injection site. Center is more firm than perimeter. Distinct borders. Measuring about 3.5 inches x 3.5 inches. No excessive warmth or drainage.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Chills - Low Grade Fever (100) - Redness and Soreness at injection site.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Myalgia, Pain of skin, Pyrexia
Clinical narrative: Fever 100.5 night of vaccine and following morning. Sore muscles. Skin tender. Sore injection site.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Hyperaesthesia, Influenza, Lethargy, Pyrexia
Clinical narrative: Fever 100.5 night of vaccine and following morning. Sore muscles. Skin tender. Sore injection site.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Insomnia, Irritability, Screaming
Clinical narrative: He has been extremely fussy and will sleep for very brief increments. He has started waking up screaming. Prior to the vaccinations, he was always a happy baby and had no difficulty sleeping for long periods of time and never woke up screaming.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis
Clinical narrative: Pt developed cellulitis at site.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Injection site warmth, Joint range of motion decreased, Pain
Clinical narrative: Pt experienced flu-like symptoms (body aches, low grade fever, chills), sore arm with injection site warmth, decreased joint mobility.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Pt experienced flu-like symptoms (body aches, low grade fever, chills), sore arm with injection site warmth, decreased joint mobility.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Vaccination complication, Varicella post vaccine
Clinical narrative: Child returned to clinic 2 days after vaccination with fluid filled blisters to trunk, head and arms, diagnosed with vaccine induced varicella.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pain, Pyrexia
Clinical narrative: Patient felt aching/soreness when she went home. She called the nurse and the nurse advised her to use hot/cold compress around the area. The next morning the injection area started to get red and spread to upper arm area but still localized at the injection site. On 6/3 around 11:30am, she called me and I advised her to stop using the compress and monitor for any fever and if the area gets hot or tender to touch. Otherwise at that time, the redness didn't bother her at all and no symptoms at the time she called me. On 6/3 around 12:45pm, she called and reported to have a slight fever at 99 degree Fahrenheit. I advised her to go to clinic, urgent care or emergency room to have it check.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood electrolytes normal, Blood test normal, Inflammation, Injection site erythema, Injection site pain
Clinical narrative: Initially arm sore and tender in injection site and hurt to move for the first 24 hours. Within 30 hours, red area appeared at the injection site and continued to grow and was hot to the touch and extremely itchy. By the 6th day about 2/3 of my upper arm was red, itchy and hot to touch. Went to urgent care and given a prescription for Clindamycin (300mg) and told if it continued to grow to go to the ER. Woke the next morning and now the entire upper arm and about 1.5 to 2 inches past my elbow was now red, itchy and hot to touch. Went to ER and they did test my blood and electrolytes and all came back normal which the doctors thought that was odd due to the amount of my arm that was inflamed. Proceeded to take my prescription and the arm seems to be healing fine.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site warmth, Pain, White blood cell count normal
Clinical narrative: Initially arm sore and tender in injection site and hurt to move for the first 24 hours. Within 30 hours, red area appeared at the injection site and continued to grow and was hot to the touch and extremely itchy. By the 6th day about 2/3 of my upper arm was red, itchy and hot to touch. Went to urgent care and given a prescription for Clindamycin (300mg) and told if it continued to grow to go to the ER. Woke the next morning and now the entire upper arm and about 1.5 to 2 inches past my elbow was now red, itchy and hot to touch. Went to ER and they did test my blood and electrolytes and all came back normal which the doctors thought that was odd due to the amount of my arm that was inflamed. Proceeded to take my prescription and the arm seems to be healing fine.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: Unremitting headache for 10 days. I never get headaches. This was not a "sinus" headache or related to any congestion. I do not suffer from migraines or other similar disorders. The onset was coincident with the administration of the vaccine, several hours later, and persisted for 10 days, gradually lessening. It was bilateral. Only partially responsive to analgesics.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient states that he has redness under the injection site and it is warm and hardened.
Age: 60.0
Sex: M
Vaccine: PPV
Symptoms: Discomfort, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient said he felt pressure in the arm during administration, about 5:30pm the arm started swelling, got red and warm to the touch. The next morning the swelling moved down to his elbow.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Redness and pain around injection site starting the day after the injection.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Erythema, Injection site warmth, Loss of personal independence in daily activities, Pain in extremity, Peripheral swelling
Clinical narrative: Very sore swollen and red arm-left for four days. Fever and warmth at the site. Missed school.
Age: 11.0
Sex: M
Vaccine: HEPA, MNQ, TDAP
Symptoms: Pyrexia
Clinical narrative: Very sore swollen and red arm-left for four days. Fever and warmth at the site. Missed school.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT REPORTED SIGNIFICANT LOCAL REACTION THAT INCLUDED REDNESS THAT HAD THE LIKENESS OF A SUNBURN ACROSS HER UPPER ARM (NOT JUST IN SITE OF ADMINISTRATION). IT FELT AS THOUGH IT WAS SWOLLEN OR BLISTED LIKE A SUNBURN BUT DID NOT ACTUALLY BLISTER (FLUID FILLED SACS). SHE STATES THAT THERE WAS HEAT TO THE TOUGH AS WELL. IT ENDED UP BRUISING AS WELL. SHE REPORTS THAT THE ARM WAS VERY VERY SORE, MUCH MORE THOUGH THAT ANTICIPATED. SHE SAID IT MADE THE ARM DIFFICULT TO USE. THESE SYMPTOMS LASTED ABOUT A WEEK. SHE HAD NO SYSTEMIC SYMTOMS.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Local reaction
Clinical narrative: PATIENT REPORTED SIGNIFICANT LOCAL REACTION THAT INCLUDED REDNESS THAT HAD THE LIKENESS OF A SUNBURN ACROSS HER UPPER ARM (NOT JUST IN SITE OF ADMINISTRATION). IT FELT AS THOUGH IT WAS SWOLLEN OR BLISTED LIKE A SUNBURN BUT DID NOT ACTUALLY BLISTER (FLUID FILLED SACS). SHE STATES THAT THERE WAS HEAT TO THE TOUGH AS WELL. IT ENDED UP BRUISING AS WELL. SHE REPORTS THAT THE ARM WAS VERY VERY SORE, MUCH MORE THOUGH THAT ANTICIPATED. SHE SAID IT MADE THE ARM DIFFICULT TO USE. THESE SYMPTOMS LASTED ABOUT A WEEK. SHE HAD NO SYSTEMIC SYMTOMS.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Erythema, Nodule, Swelling
Clinical narrative: Knot in arm day after, then 2nd day after vaccination got very red, swollen and uncomfortable. Took about a week to go down.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Hives all over her body for a full week, only responding to allegra.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: Patient claims that 10 - 12 red round spots with white centers appeared on his legs, one on his hip and one on his chest. He believes this is due to the vaccine. Patient was told to visit the Dr office and report back the finding. He has yet to call us and did not answer his phone when pharmacist tried to follow up.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Myelitis transverse, Neck pain, Pain in extremity
Clinical narrative: Pt reported severe neck pain radiating down left arm. She went to the ER and was diagnosed with transverse myelitis at C2. More information will be available from the facility that treated her, but I do not know who it was.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Flushing, Influenza like illness, Pain
Clinical narrative: Felt achy and face felt flushed, no fever (checked 3 times), flu like symptoms.
Age: 16.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Tingling in Legs. Numb Feet. Shooting Pain in Arms.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain
Clinical narrative: Redness that continues to spread at the injection site. Pain at the injection site. Dull headache.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Blister, Injection site erythema, Injection site reaction, Mobility decreased, Pain in extremity
Clinical narrative: I rec'd the Tdap IM in my (R) arm as above because I was due. I was also given the PNEUMOVAX shot in the SQ area to the back of my (R) arm a few inches below the IM shot. That evening the (R) shoulder was sore as expected with tetanus shots. On 3/27, The next day everything seemed normal until about 6pm when I felt 6-7 welts rising up in the area I got the PNEUMOVAX 23 shot. I had rec'd my 7th dose of allergy shots near that area on 3/22/18 but had no skin reaction from them since 3/22/18. By 3/28 AM the welts started coming together to form a 2x3 in area and by the evening began to get bigger redder. By 3/29 The area was so painful and sore, I had fever and chills and developed into full cellulitis of my arm. I saw Dr. in the office and she prescribed TYLENOL alternating w/Ibuprofen and BENADRYL. I have a fever of 101.6 after ADVIL. 3/29/18 I was so sick and could barely move and still had fever of 100.6 despite TYLENOL and Ibuprofen. With the full blown cellulitis. Dr. at the office prescribed KEFLEX 4x daily. Tetanus soreness is gone. 3/30 My arm was still very hard and swollen and painful down to my elbow and extending under to the front of my entire tricep of my arm. The area went from bright red to bright pink. 3/31 Area still had and very painful. Area getting smaller. 4/3 I returned to work. 4/6/18 Area still hard less red but still tender. About a 4x6 area muscle stretches tight when I lift my arm. 4/7/18 Antibiotics completed but I still have a hard 4x6 lump. 4/9/18 2 wks after injection, Lump 4x5 inch still hard and painful an my upper back muscles very sore and difficulty sleeping on (R) arm. 4/16/18 3 wks after injection Lump 3x4 inches. Golf ball size. On 4/12/18 seen my FNP. She seemed concerned and asked me to call other to ask their opinion. 5/17/18 I returned from my vacation and call Merck and reported a continued lump about 2x3 in. I spoke with a Merck pharmacist who said she had not heard of a lump for any longer than 2 wks. 5/18/18 As of today I am still experiencing a hard lump on my upper (R) arm below the deltoid. 5/21/18 No changes. I received a call from Dr. from Merck. She stated that she say my pictures of my arm that I emailed Merck and that my arm looked like cellulitis and it was good I went on antibiotics. She also said she did not know how long the lump would be in my arm and she had not heard of any other cases where a lump stayed this long. Thank you, Patient, RN, BSN 5/21/18.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Peripheral swelling, Pyrexia, Tenderness, Urticaria
Clinical narrative: I rec'd the Tdap IM in my (R) arm as above because I was due. I was also given the PNEUMOVAX shot in the SQ area to the back of my (R) arm a few inches below the IM shot. That evening the (R) shoulder was sore as expected with tetanus shots. On 3/27, The next day everything seemed normal until about 6pm when I felt 6-7 welts rising up in the area I got the PNEUMOVAX 23 shot. I had rec'd my 7th dose of allergy shots near that area on 3/22/18 but had no skin reaction from them since 3/22/18. By 3/28 AM the welts started coming together to form a 2x3 in area and by the evening began to get bigger redder. By 3/29 The area was so painful and sore, I had fever and chills and developed into full cellulitis of my arm. I saw Dr. in the office and she prescribed TYLENOL alternating w/Ibuprofen and BENADRYL. I have a fever of 101.6 after ADVIL. 3/29/18 I was so sick and could barely move and still had fever of 100.6 despite TYLENOL and Ibuprofen. With the full blown cellulitis. Dr. at the office prescribed KEFLEX 4x daily. Tetanus soreness is gone. 3/30 My arm was still very hard and swollen and painful down to my elbow and extending under to the front of my entire tricep of my arm. The area went from bright red to bright pink. 3/31 Area still had and very painful. Area getting smaller. 4/3 I returned to work. 4/6/18 Area still hard less red but still tender. About a 4x6 area muscle stretches tight when I lift my arm. 4/7/18 Antibiotics completed but I still have a hard 4x6 lump. 4/9/18 2 wks after injection, Lump 4x5 inch still hard and painful an my upper back muscles very sore and difficulty sleeping on (R) arm. 4/16/18 3 wks after injection Lump 3x4 inches. Golf ball size. On 4/12/18 seen my FNP. She seemed concerned and asked me to call other to ask their opinion. 5/17/18 I returned from my vacation and call Merck and reported a continued lump about 2x3 in. I spoke with a Merck pharmacist who said she had not heard of a lump for any longer than 2 wks. 5/18/18 As of today I am still experiencing a hard lump on my upper (R) arm below the deltoid. 5/21/18 No changes. I received a call from Dr. from Merck. She stated that she say my pictures of my arm that I emailed Merck and that my arm looked like cellulitis and it was good I went on antibiotics. She also said she did not know how long the lump would be in my arm and she had not heard of any other cases where a lump stayed this long. Thank you, Patient, RN, BSN 5/21/18.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Back pain, Cellulitis, Chills, Erythema, Hypokinesia
Clinical narrative: I rec'd the Tdap IM in my (R) arm as above because I was due. I was also given the PNEUMOVAX shot in the SQ area to the back of my (R) arm a few inches below the IM shot. That evening the (R) shoulder was sore as expected with tetanus shots. On 3/27, The next day everything seemed normal until about 6pm when I felt 6-7 welts rising up in the area I got the PNEUMOVAX 23 shot. I had rec'd my 7th dose of allergy shots near that area on 3/22/18 but had no skin reaction from them since 3/22/18. By 3/28 AM the welts started coming together to form a 2x3 in area and by the evening began to get bigger redder. By 3/29 The area was so painful and sore, I had fever and chills and developed into full cellulitis of my arm. I saw Dr. in the office and she prescribed TYLENOL alternating w/Ibuprofen and BENADRYL. I have a fever of 101.6 after ADVIL. 3/29/18 I was so sick and could barely move and still had fever of 100.6 despite TYLENOL and Ibuprofen. With the full blown cellulitis. Dr. at the office prescribed KEFLEX 4x daily. Tetanus soreness is gone. 3/30 My arm was still very hard and swollen and painful down to my elbow and extending under to the front of my entire tricep of my arm. The area went from bright red to bright pink. 3/31 Area still had and very painful. Area getting smaller. 4/3 I returned to work. 4/6/18 Area still hard less red but still tender. About a 4x6 area muscle stretches tight when I lift my arm. 4/7/18 Antibiotics completed but I still have a hard 4x6 lump. 4/9/18 2 wks after injection, Lump 4x5 inch still hard and painful an my upper back muscles very sore and difficulty sleeping on (R) arm. 4/16/18 3 wks after injection Lump 3x4 inches. Golf ball size. On 4/12/18 seen my FNP. She seemed concerned and asked me to call other to ask their opinion. 5/17/18 I returned from my vacation and call Merck and reported a continued lump about 2x3 in. I spoke with a Merck pharmacist who said she had not heard of a lump for any longer than 2 wks. 5/18/18 As of today I am still experiencing a hard lump on my upper (R) arm below the deltoid. 5/21/18 No changes. I received a call from Dr. from Merck. She stated that she say my pictures of my arm that I emailed Merck and that my arm looked like cellulitis and it was good I went on antibiotics. She also said she did not know how long the lump would be in my arm and she had not heard of any other cases where a lump stayed this long. Thank you, Patient, RN, BSN 5/21/18.
Age: 51.0
Sex: F
Vaccine: PPV, TDAP, PPV, TDAP
Symptoms: Induration, Injection site mass, Pain in extremity, Pyrexia, Urticaria
Clinical narrative: I rec'd the Tdap IM in my (R) arm as above because I was due. I was also given the PNEUMOVAX shot in the SQ area to the back of my (R) arm a few inches below the IM shot. That evening the (R) shoulder was sore as expected with tetanus shots. On 3/27, The next day everything seemed normal until about 6pm when I felt 6-7 welts rising up in the area I got the PNEUMOVAX 23 shot. I had rec'd my 7th dose of allergy shots near that area on 3/22/18 but had no skin reaction from them since 3/22/18. By 3/28 AM the welts started coming together to form a 2x3 in area and by the evening began to get bigger redder. By 3/29 The area was so painful and sore, I had fever and chills and developed into full cellulitis of my arm. I saw Dr. in the office and she prescribed TYLENOL alternating w/Ibuprofen and BENADRYL. I have a fever of 101.6 after ADVIL. 3/29/18 I was so sick and could barely move and still had fever of 100.6 despite TYLENOL and Ibuprofen. With the full blown cellulitis. Dr. at the office prescribed KEFLEX 4x daily. Tetanus soreness is gone. 3/30 My arm was still very hard and swollen and painful down to my elbow and extending under to the front of my entire tricep of my arm. The area went from bright red to bright pink. 3/31 Area still had and very painful. Area getting smaller. 4/3 I returned to work. 4/6/18 Area still hard less red but still tender. About a 4x6 area muscle stretches tight when I lift my arm. 4/7/18 Antibiotics completed but I still have a hard 4x6 lump. 4/9/18 2 wks after injection, Lump 4x5 inch still hard and painful an my upper back muscles very sore and difficulty sleeping on (R) arm. 4/16/18 3 wks after injection Lump 3x4 inches. Golf ball size. On 4/12/18 seen my FNP. She seemed concerned and asked me to call other to ask their opinion. 5/17/18 I returned from my vacation and call Merck and reported a continued lump about 2x3 in. I spoke with a Merck pharmacist who said she had not heard of a lump for any longer than 2 wks. 5/18/18 As of today I am still experiencing a hard lump on my upper (R) arm below the deltoid. 5/21/18 No changes. I received a call from Dr. from Merck. She stated that she say my pictures of my arm that I emailed Merck and that my arm looked like cellulitis and it was good I went on antibiotics. She also said she did not know how long the lump would be in my arm and she had not heard of any other cases where a lump stayed this long. Thank you, Patient, RN, BSN 5/21/18.
Age: 63.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Rash, Swelling
Clinical narrative: This spontaneous report was received from a 63 year old male patient referring to himself. The patient's concurrent conditions included parkinson's disease. The patient's drug reactions or allergies were reported as "none". On 19-MAR-2018, the patient was vaccinated with a dose of PNEUMOVAX 23, by intramuscular route (dose, anatomical location, lot number and expiration date were not provided), for vaccination. Concomitant therapies included ropinirole, carbidopa (+) levodopa, amantadine and safinamide mesylate (XADAGO). On 20-MAR-2018, the following day after vaccination with PNEUMOVAX 23, the patient experienced swelling and pain in his neck, which was diagnosed as cellulitis for a nurse practitioner at the clinic. Accordingly, the patient was prescribed cephalexin, 500 mg, twice daily for 10 days. It was reported that the condition subsided but returned on an unspecified date in 2018. Therefore, on an unknown day in 2018, he went to the clinic again and was given another identical prescription. In addition, on an unspecified day in 2018, a full blood analysis was performed (results were not provided). At the reporting time, the patient had not recovered from the cellulitis. The causal relationship between the cellulitis and the PNEUMOVAX 23 was not reported. Upon internal review, the cellulitis was determined to be a medically significant event.
Age: 63.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Cellulitis, Full blood count, Neck pain, Swelling
Clinical narrative: This spontaneous report was received from a 63 year old male patient referring to himself. The patient's concurrent conditions included parkinson's disease. The patient's drug reactions or allergies were reported as "none". On 19-MAR-2018, the patient was vaccinated with a dose of PNEUMOVAX 23, by intramuscular route (dose, anatomical location, lot number and expiration date were not provided), for vaccination. Concomitant therapies included ropinirole, carbidopa (+) levodopa, amantadine and safinamide mesylate (XADAGO). On 20-MAR-2018, the following day after vaccination with PNEUMOVAX 23, the patient experienced swelling and pain in his neck, which was diagnosed as cellulitis for a nurse practitioner at the clinic. Accordingly, the patient was prescribed cephalexin, 500 mg, twice daily for 10 days. It was reported that the condition subsided but returned on an unspecified date in 2018. Therefore, on an unknown day in 2018, he went to the clinic again and was given another identical prescription. In addition, on an unspecified day in 2018, a full blood analysis was performed (results were not provided). At the reporting time, the patient had not recovered from the cellulitis. The causal relationship between the cellulitis and the PNEUMOVAX 23 was not reported. Upon internal review, the cellulitis was determined to be a medically significant event.
Age: 63.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Antinuclear antibody, Borrelia test, C-reactive protein, Differential white blood cell count, Erythema
Clinical narrative: This spontaneous report was received from a 63 year old male patient referring to himself. The patient's concurrent conditions included parkinson's disease. The patient's drug reactions or allergies were reported as "none". On 19-MAR-2018, the patient was vaccinated with a dose of PNEUMOVAX 23, by intramuscular route (dose, anatomical location, lot number and expiration date were not provided), for vaccination. Concomitant therapies included ropinirole, carbidopa (+) levodopa, amantadine and safinamide mesylate (XADAGO). On 20-MAR-2018, the following day after vaccination with PNEUMOVAX 23, the patient experienced swelling and pain in his neck, which was diagnosed as cellulitis for a nurse practitioner at the clinic. Accordingly, the patient was prescribed cephalexin, 500 mg, twice daily for 10 days. It was reported that the condition subsided but returned on an unspecified date in 2018. Therefore, on an unknown day in 2018, he went to the clinic again and was given another identical prescription. In addition, on an unspecified day in 2018, a full blood analysis was performed (results were not provided). At the reporting time, the patient had not recovered from the cellulitis. The causal relationship between the cellulitis and the PNEUMOVAX 23 was not reported. Upon internal review, the cellulitis was determined to be a medically significant event.
Age: 63.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Full blood count, Metabolic function test, Musculoskeletal pain, Neck pain, Red blood cell sedimentation rate
Clinical narrative: This spontaneous report was received from a 63 year old male patient referring to himself. The patient's concurrent conditions included parkinson's disease. The patient's drug reactions or allergies were reported as "none". On 19-MAR-2018, the patient was vaccinated with a dose of PNEUMOVAX 23, by intramuscular route (dose, anatomical location, lot number and expiration date were not provided), for vaccination. Concomitant therapies included ropinirole, carbidopa (+) levodopa, amantadine and safinamide mesylate (XADAGO). On 20-MAR-2018, the following day after vaccination with PNEUMOVAX 23, the patient experienced swelling and pain in his neck, which was diagnosed as cellulitis for a nurse practitioner at the clinic. Accordingly, the patient was prescribed cephalexin, 500 mg, twice daily for 10 days. It was reported that the condition subsided but returned on an unspecified date in 2018. Therefore, on an unknown day in 2018, he went to the clinic again and was given another identical prescription. In addition, on an unspecified day in 2018, a full blood analysis was performed (results were not provided). At the reporting time, the patient had not recovered from the cellulitis. The causal relationship between the cellulitis and the PNEUMOVAX 23 was not reported. Upon internal review, the cellulitis was determined to be a medically significant event.
Age: 63.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Spinal pain, Swelling
Clinical narrative: This spontaneous report was received from a 63 year old male patient referring to himself. The patient's concurrent conditions included parkinson's disease. The patient's drug reactions or allergies were reported as "none". On 19-MAR-2018, the patient was vaccinated with a dose of PNEUMOVAX 23, by intramuscular route (dose, anatomical location, lot number and expiration date were not provided), for vaccination. Concomitant therapies included ropinirole, carbidopa (+) levodopa, amantadine and safinamide mesylate (XADAGO). On 20-MAR-2018, the following day after vaccination with PNEUMOVAX 23, the patient experienced swelling and pain in his neck, which was diagnosed as cellulitis for a nurse practitioner at the clinic. Accordingly, the patient was prescribed cephalexin, 500 mg, twice daily for 10 days. It was reported that the condition subsided but returned on an unspecified date in 2018. Therefore, on an unknown day in 2018, he went to the clinic again and was given another identical prescription. In addition, on an unspecified day in 2018, a full blood analysis was performed (results were not provided). At the reporting time, the patient had not recovered from the cellulitis. The causal relationship between the cellulitis and the PNEUMOVAX 23 was not reported. Upon internal review, the cellulitis was determined to be a medically significant event.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Skin warm
Clinical narrative: 5/11/18 4:30pm - started flu like symptoms - achy tired 8:30pm or so - developed fever (did not have therm to get temp) - felt very high, took 2 Advil every 4 hours and put cold cloths on head  and body to try and reduce. Kept that up over night. 5/12/18 8:30am or so - fever broke and I felt better. But felt so bad overnight that I am afraid to get the second dose.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Influenza like illness, Pain, Pyrexia
Clinical narrative: 5/11/18 4:30pm - started flu like symptoms - achy tired 8:30pm or so - developed fever (did not have therm to get temp) - felt very high, took 2 Advil every 4 hours and put cold cloths on head  and body to try and reduce. Kept that up over night. 5/12/18 8:30am or so - fever broke and I felt better. But felt so bad overnight that I am afraid to get the second dose.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Blood test normal, Febrile convulsion, Urine analysis normal
Clinical narrative: 2 Febrile Seizures.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Bilirubin conjugated normal, Blood bilirubin increased, Blood chloride normal, Blood creatine phosphokinase increased
Clinical narrative: Within 24 hours local site muscle ache, soreness. Progressed to generalized weakness, fatigue, nausea and early satiety. Now about 2 weeks out patient is being hospitalized for high-grade fevers, lower extremity weakness concerning for Guillain-Barre, ongoing nausea and fatigue.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood creatinine normal, Blood glucose increased, Blood lactic acid, Blood potassium decreased, Blood sodium normal
Clinical narrative: Within 24 hours local site muscle ache, soreness. Progressed to generalized weakness, fatigue, nausea and early satiety. Now about 2 weeks out patient is being hospitalized for high-grade fevers, lower extremity weakness concerning for Guillain-Barre, ongoing nausea and fatigue.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood thyroid stimulating hormone decreased, Blood urea normal, Carbon dioxide decreased, Early satiety, Fatigue
Clinical narrative: Within 24 hours local site muscle ache, soreness. Progressed to generalized weakness, fatigue, nausea and early satiety. Now about 2 weeks out patient is being hospitalized for high-grade fevers, lower extremity weakness concerning for Guillain-Barre, ongoing nausea and fatigue.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Glucose urine present, Haemoglobin decreased, International normalised ratio normal, Lipase normal, Liver function test normal
Clinical narrative: Within 24 hours local site muscle ache, soreness. Progressed to generalized weakness, fatigue, nausea and early satiety. Now about 2 weeks out patient is being hospitalized for high-grade fevers, lower extremity weakness concerning for Guillain-Barre, ongoing nausea and fatigue.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Muscular weakness, Myalgia, Nausea, Neutrophil count increased, Pain
Clinical narrative: Within 24 hours local site muscle ache, soreness. Progressed to generalized weakness, fatigue, nausea and early satiety. Now about 2 weeks out patient is being hospitalized for high-grade fevers, lower extremity weakness concerning for Guillain-Barre, ongoing nausea and fatigue.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Platelet count normal, Protein urine present, Pyrexia, Red blood cells urine positive, Respiratory syncytial virus test negative
Clinical narrative: Within 24 hours local site muscle ache, soreness. Progressed to generalized weakness, fatigue, nausea and early satiety. Now about 2 weeks out patient is being hospitalized for high-grade fevers, lower extremity weakness concerning for Guillain-Barre, ongoing nausea and fatigue.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Shift to the left, Urinary sediment present, Urine analysis abnormal, Urine ketone body present, White blood cell count increased
Clinical narrative: Within 24 hours local site muscle ache, soreness. Progressed to generalized weakness, fatigue, nausea and early satiety. Now about 2 weeks out patient is being hospitalized for high-grade fevers, lower extremity weakness concerning for Guillain-Barre, ongoing nausea and fatigue.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: White blood cells urine positive, pH urine normal
Clinical narrative: Within 24 hours local site muscle ache, soreness. Progressed to generalized weakness, fatigue, nausea and early satiety. Now about 2 weeks out patient is being hospitalized for high-grade fevers, lower extremity weakness concerning for Guillain-Barre, ongoing nausea and fatigue.
Age: 33.0
Sex: M
Vaccine: VARCEL
Symptoms: Pruritus, Rash, Scab, Skin ulcer
Clinical narrative: Information has been received from a registered nurse referring to a 33 year old male patient. There were no pertinent medical history or drug reaction/allergies. Concomitant therapy included unspecified vitamins. On 04-APR-2018, the patient was vaccinated with the first dose of VARIVAX (lot # N022983 expiration date 23-AUG-2019, dose and route not reported) for prophylaxis. The vaccine was reconstituted with sterile diluent (manufacturer unknown) (lot #, expiration, dose and route not reported). It was reported that no documentation for titers, the patient had never had VARIVAX.On approximately 18-APR-2018, about 2 weeks after VARIVAX administration, the patient experienced "a rash" on an unspecified region of the body described as "sores" and "scabs". He also experienced "itching" at the rash site. The patient sought medical attention. The nurse reported as treatment, the patient was prescribed VALTREX and an unspecified topical prednisone. No labs were performed. The symptoms had resolved on an unspecified date in April 2018 (described as "a couple of days after treatment"). The causality between the events and suspect therapies were not provided. No further clarifying information was provided.
Age: 6.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report was received from a registered nurse regarding a 6 year old female patient. The patient's medical history, concurrent conditions, concomitant medication and drug reactions/allergies were not provided. On 23-MAY-2018, the patient was inadvertently vaccinated with GARDASIL 9 injection, intramuscularly, 0.5 mL once, lot # N021571 with expiration date 29-MAY-2020, for prophylaxis (anatomical location were not provided). No adverse effects were reported. The patient was doing fine then, did not seek medical attention or received treatment.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: Information was received from a nurse referring to 2 patients of unknown age and gender. The patients' medical history, concurrent conditions, concomitant medications, drug reactions and allergies were not reported. On an unknown date, the patients were vaccinated with improperly stored ROTATEQ for prophylaxis (incorrect product storage). The vaccines of lot numbers N005078 and N029868 were exposed to a temperature between 47 and 77 Fahrenheit degrees(F) (55 F) for 5 hours with previous temperature excursion between 47 F and 77 F(47.1 F) for 10 minutes as well as to a temperature between 47 F and 77 F (57.3 F) for 14 hours. No call for data logger was involved. No adverse effects were reported.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse practitioner regarding a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On an unknown date, the patient was vaccinated with VARIVAX subcutaneous injection, per intramuscular route in error, for prophylaxis (strength, dose, frequency, anatomical location, lot # and expiry date were not provided). No known adverse effects were reported.
Sex: M
Vaccine: HPV9
Symptoms: Concussion, Face injury, Fall, Loss of consciousness
Clinical narrative: This spontaneous report was received from a medical assistant referring to a 14 year old male patient. The patient had no medical history, concurrent conditions, drug reactions/allergies or concomitant medications. The medical assistant reported that the patient's mother stated the patient was light headed in the waiting room before receiving the vaccine. On 27-APR-2018, the patient was vaccinated with one dose of GARDASIL 9 lot # N021572, expiration date on 01-MAY-2020, (strength, route or anatomical location were not reported) for prevention of HPV related disease and cervical cancer. On the same date, the patient passed out (non-serious adverse event-NSAE) and fell face first on the floor (NSAE), hitting his face and chin shortly (face injury-NSAE) after receiving the vaccine. The patient was transported from the Physician office to an unspecified emergency room by ambulance on the same day. Later, the patient was diagnosed with a concussion (NSAE) in the emergency room but the patient was not admitted to the hospital. On an unknown date in 2018, the patient recovered from all the events. The causal relationship between all the events and the suspect therapy was not provided.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Acupuncture, Eye swelling, Herpes zoster, Laser therapy, Ophthalmic herpes zoster
Clinical narrative: This spontaneous report was received from a 79 year old female patient, who was reporting on herself. The patient did not have medical history, concurrent conditions, concomitant medications, drug reactions or allergies. In November 2012, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) (lot #, expiration date, anatomical location or route of administration were not provided), one injection was administered to avoid shingles. In January 2017, the patient had shingles in her right eye (ophthalmic herpes zoster) and in her scalp (herpes zoster). The patient said shingles started in her right eye with her eye getting very swollen within a week. She also developed post herpetic neuralgia (PHN) which caused a headache in her scalp every day; so she had used creams, shampoos and conditioners on her scalp but they all burn. Therefore, she had try acupuncture and cold laser therapy to relieve the pain; the last one seemed to help relieve some of the PHN pain, but the pain persists. The patient said she might consider seeing a neurologist. Her physician was treating her shingles with a 300 mg of gabapentin tablet, which the patient was told to take 4-5 times a day, but she only takes 3 times a day. The patient said the medication did not seem to be working. At the time of this report, the patient had not recovered yet from the ophthalmic herpes zoster, shingles and PHN. The causal relationship between the ophthalmic herpes zoster, shingles and PHN with ZOSTAVAX was not provided. Upon internal review, the ophthalmic herpes zoster was determined to be a medically significant event.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain of skin, Post herpetic neuralgia, Skin burning sensation
Clinical narrative: This spontaneous report was received from a 79 year old female patient, who was reporting on herself. The patient did not have medical history, concurrent conditions, concomitant medications, drug reactions or allergies. In November 2012, the patient was vaccinated with ZOSTAVAX 19400 plaque-forming unit (PFU) (lot #, expiration date, anatomical location or route of administration were not provided), one injection was administered to avoid shingles. In January 2017, the patient had shingles in her right eye (ophthalmic herpes zoster) and in her scalp (herpes zoster). The patient said shingles started in her right eye with her eye getting very swollen within a week. She also developed post herpetic neuralgia (PHN) which caused a headache in her scalp every day; so she had used creams, shampoos and conditioners on her scalp but they all burn. Therefore, she had try acupuncture and cold laser therapy to relieve the pain; the last one seemed to help relieve some of the PHN pain, but the pain persists. The patient said she might consider seeing a neurologist. Her physician was treating her shingles with a 300 mg of gabapentin tablet, which the patient was told to take 4-5 times a day, but she only takes 3 times a day. The patient said the medication did not seem to be working. At the time of this report, the patient had not recovered yet from the ophthalmic herpes zoster, shingles and PHN. The causal relationship between the ophthalmic herpes zoster, shingles and PHN with ZOSTAVAX was not provided. Upon internal review, the ophthalmic herpes zoster was determined to be a medically significant event.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 25-MAY-2018, the patient was vaccinated with second dose of GARDASIL 9 injection lot # N023828 expiry date: 25-JUN-2020 for prophylaxis (strength, dose, dosage schedule and anatomical location were not provided). The nurse reported that the patient received the first dose of GARDASIL 9 on 17-APR-2017. No adverse effect was reported.
Sex: U
Vaccine: HIBV, RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a medical assistant concerning a patient of unknown age and gender. Pertinent medical history, concurrent conditions, drug reactions/allergies and concomitant medications were not reported. On 14-MAY-2018, the patient was vaccinated with improperly storage doses of ROTATEQ, lot # M046008, expiry date: 29-JUN-2019, orally, for prophylaxis (strength, dose, route and dosage schedule were not provided) and PEDVAXHIB injection, lot #N01893, expiry date 30-APR-2020 for prophylaxis (strength, dose, route, anatomical location and dosage schedule were not provided). No adverse effects were reported. The temperature excursion and time frame for both vaccines was between 47°F to 77°F for 30 minutes. No previous temperature excursion was reported. Data logger was reported.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient developed a 65mm diameter red slightly raised area at injection site. No fever. He was treated with ibuprofen, oral BENADRYL, and topical BENADRYL. Symptoms resolved in 48 hours.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Dizziness, Headache, Injection site erythema
Clinical narrative: IN CHRONOLOGICAL ORDER: HEADACHE, DIZZINESS, NAUSEA, FEELING OF WEAKNESS, INJECTION SITE PAIN AND REDNESS, MYALGIA, ARTHRALGIA.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Myalgia, Nausea
Clinical narrative: IN CHRONOLOGICAL ORDER: HEADACHE, DIZZINESS, NAUSEA, FEELING OF WEAKNESS, INJECTION SITE PAIN AND REDNESS, MYALGIA, ARTHRALGIA.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Asthenia, Continuous positive airway pressure, Dizziness, Erythema
Clinical narrative: IN CHRONOLOGICAL ORDER: HEADACHE, DIZZINESS, NAUSEA, FEELING OF WEAKNESS, INJECTION SITE PAIN AND REDNESS, MYALGIA, ARTHRALGIA.
Age: 58.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Headache, Impaired work ability, Myalgia, Nausea
Clinical narrative: IN CHRONOLOGICAL ORDER: HEADACHE, DIZZINESS, NAUSEA, FEELING OF WEAKNESS, INJECTION SITE PAIN AND REDNESS, MYALGIA, ARTHRALGIA.