chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.25
Sex: F
Vaccine: TDAP
Symptoms: Incorrect dose administered, Injection site pain, Underdose, Wrong drug administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of underdose in a 15-month-old female patient who received BOOSTRIX (batch number G932P, expiry date 30th November 2019). On an unknown date, the patient received BOOSTRIX. On an unknown date, unknown after receiving BOOSTRIX, the patient experienced underdose and inappropriate age at vaccine administration. On an unknown date, the outcome of the underdose and inappropriate age at vaccine administration were unknown. Additional information was received as follows: The 15 months old patient inadvertently received a dose of BOOSTRIX (reduced antigen), instead of DTaP, which led to accidental underdose and inappropriate age at vaccine administration. No further information was reported. Follow up information received from nurse on 13th March 2018: The patient's demographic details were reported. The patient received 0.5 ml dose of BOOSTRIX intramuscularly as 4th dose in the DTaP series. Less than a month, after receiving BOOSTRIX, the patient experienced soreness at injection site. Error occurred in selecting the correct vaccine with unknown contributing factors. The person double checking the vaccine did not catch it. The VAERS information was updated. This case was medication error with adverse event.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 61-year-old female patient who received SHINGRIX (batch number 9XC39, expiry date 30th January 2020). Co-suspect products included Influenza vaccine Quadrivalent. Concomitant products included BOOSTRIX. On 14th March 2018, the patient received the 1st dose of SHINGRIX (intramuscular). On an unknown date, the patient received Influenza vaccine Quadrivalent at an unknown dose. On 14th March 2018, less than a day after receiving SHINGRIX and not applicable after receiving Influenza vaccine Quadrivalent, the patient experienced pain in arm and activities of daily living impaired. On an unknown date, the patient experienced vaccine administered at inappropriate site. On an unknown date, the outcome of the pain in arm was not recovered/not resolved and the outcome of the activities of daily living impaired and vaccine administered at inappropriate site were unknown. The reporter considered the pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the activities of daily living impaired to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient received the SHINGRIX vaccine in her left upper arm muscle yesterday morning on 14th March 2018. The patient was not able to report to work this afternoon due to the pain. The patient had pain from her elbow up to her neck on her left arm. The patient was in tears this morning because she could not roll over in her bed. The patient noted she also received the BOOSTRIX vaccine, and asked the nurse practitioner that was giving the medications to give her the one that would hurt the most in her right arm, but she stated her pain is all in the left. The patient drives a school bus, had to lift kids and press airbrakes and she was not able to do any of that. The patient also noted she would like to get the second shot of the SHINGRIX in her buttock and asked it that could be done, she was referred to her physician. The patient noted she had received a flu vaccine in her buttock three years ago and had no problems. The patient did not know the manufacturer of the flu vaccine.
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Pyrexia, Rash
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of rash in a male patient who received SHINGRIX. On 9th March 2018, the patient received SHINGRIX (subcutaneous). On 9th March 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route. In March 2018, the patient experienced rash and fever. On 14th March 2018, the outcome of the rash was recovered/resolved. In March 2018, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown. It was unknown if the reporter considered the rash and fever to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient reported that at pharmacy the vaccine was accidently given to him to the back of his arm as a subcutaneous injection and not the side of his arm as an intramuscular injection, which led to intramuscular formulation administered by other route. The patient asked about the effects of SHINGRIX being administered in back of arm instead of intramuscular. The patient experienced experienced and 8 inch long by 2 inch wide rash. The patient also experienced a low-grade fever that lasted one day. The patient later went to a different pharmacy to show the pharmacist the rash. The pharmacist explained that the vaccine should have been given intramuscular (IM). The pharmacist who originally gave the vaccine did not know that the new vaccine was intramuscular.
Age: 12.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth
Clinical narrative: (L) upper arm redness, hot to touch, edema to injection site, required 2 grams of ROCEPHIN IM and then KEFLEX 500mg PO BID x 10days.
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Fall
Clinical narrative: Pt Received first dose of Gardasil 9 and was light headed and dizzy. Pt stood up, and fell may have hit back of head on wall. Pt never fell all the way to floor, caught on table.
Age: 20.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Pallor
Clinical narrative: Patient received dose of MENACTRA as required for school. As Patient was leaving the Pharmacy he felt faint. Patient skin was pale, he did not lose consciousness, was awake. Mother and I assisted the patient. It took about 1min-1.5 min he was completed recovered. Pat. had a drink of juice and left the store.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Headache, Injection site pain, Malaise
Clinical narrative: Patient complains about pain at injection site and down the left arm at time of vaccination. Pt. states that in the afternoon she became fatigued and is experiencing malaise. She had a severe headache yesterday that is only a mild headache today. Pt. also complains of hives that started yesterday. She has taken oral BENADRYL tabs last night, oral liquid BENDADRYL today as well as, applying BENADRYL lotion. Pt. was given Rx for prednisone and informed on when to go to the ER. She was also advised on the use of OTC antihistamine medications.
Age: 1.67
Sex: M
Vaccine: HIBV
Symptoms: Injection site rash, Rash
Clinical narrative: Patient developed a very fine sand paper like rash at the injection site (Left deltoid), 5 minutes after administration of the Hib vaccine. Rash then spread to rest of the left arm, face, and edges of both ears.
Age: 72.0
Sex: F
Vaccine: TDAP
Symptoms: Burning sensation
Clinical narrative: The day after, starting to have burning sensation from the chest down to the the bottom of feet.  No burning on head, neck, fingers or toes. Pt can tell it's not her normal arthritic pain. Burning worse at bedtime. That's when noticed more. During the day too busy to notice. 3 days out and burning still the same.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Vomiting
Clinical narrative: Nausea, mild vomiting, chills, headache.
Age: 87.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pruritus, Rash erythematous, Swelling, Tenderness
Clinical narrative: Swelling red itching - red rash under left armpit, tender to the touch.
Age: 1.25
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Decreased activity, Hypophagia, Insomnia, Pyrexia, Rash erythematous
Clinical narrative: Fever between 101/102. Little red bumps all over body. Body aches- child screaming, would not eat, play or sleep longer than one hour for 2 days.
Age: 1.25
Sex: M
Vaccine: HIBV, MMRV
Symptoms: Rash generalised, Screaming
Clinical narrative: Fever between 101/102. Little red bumps all over body. Body aches- child screaming, would not eat, play or sleep longer than one hour for 2 days.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Nausea, Pain, Vomiting
Clinical narrative: The following morning after receiving vaccine the patient  reported severe nausea and vomiting.  He reported extreme fatigue and body aches as well. All of these symptoms lasted for about 24 hours. He also reported signifcant injection site pain that lasted about 4 days.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Pyrexia
Clinical narrative: Chills, fever, in middle of the night x 2 nights, and lightheadedness 03/24/18 morning.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Patient states reported sustained soreness in his left arm beginning the day after his vaccination, and continuing through today. He is uncertain if the soreness he is experiencing today is related to the vaccine, or if other causes may be contributing. He is scheduled for an MRI to identify the source of his continued pain.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Confusional state, Injection site pain, Injection site swelling, Myalgia
Clinical narrative: Pain at injection site, swelling and large red blotch at injection site, muscle pains whole body, chills, confusion, blurred vision, confusion. Onset a few hours after, lasting 48 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash macular, Vision blurred
Clinical narrative: Pain at injection site, swelling and large red blotch at injection site, muscle pains whole body, chills, confusion, blurred vision, confusion. Onset a few hours after, lasting 48 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Arthralgia, Chills, Erythema, Headache, Malaise
Clinical narrative: Pain at injection site, swelling and large red blotch at injection site, muscle pains whole body, chills, confusion, blurred vision, confusion. Onset a few hours after, lasting 48 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mobility decreased, Myalgia, Nausea, Peripheral swelling, Pyrexia
Clinical narrative: Pain at injection site, swelling and large red blotch at injection site, muscle pains whole body, chills, confusion, blurred vision, confusion. Onset a few hours after, lasting 48 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Tremor, Wheezing
Clinical narrative: Pain at injection site, swelling and large red blotch at injection site, muscle pains whole body, chills, confusion, blurred vision, confusion. Onset a few hours after, lasting 48 hours.
Age: 23.0
Sex: M
Vaccine: ANTH
Symptoms: Induration, Skin warm, Tenderness
Clinical narrative: 5 cm induration, warmth, mild-moderate tenderness just below vaccine site beginning about 20 hours after vaccine. Given ibuprofen.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Contusion, Pain, Skin discolouration
Clinical narrative: VERY LARGE CONTUSION - ABOUT THE SIZE OF A FIST - VERY SORE AND BLACK. SORENESS STARTED SEVERAL HOURS LATER, PT BECARE AWARE OF THE DISCOLORATION THE NEXT MORNING. AREA IS STILL HEALING AT THIS TIME.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood glucose decreased, Seizure
Clinical narrative: Seizure lasting about 10 to 15 minutes. Ambulance arrived. Blood sugar of patient was 60 and given oral glucose once conscious. Patient left on his own and drove home after about 30 minutes.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Myalgia, Nausea
Clinical narrative: Patient is experiencing nausea, headache, myalgias, and erythemia. Patient has been experiencing symptoms for past 48 hours.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Erythema, Injection site swelling, Myalgia, Nausea
Clinical narrative: Patient is experiencing dizziness, nausea, erythema, myalgias, and swelling at the site of injection. Events began about 24 hours after injection. Symptoms have since persisted for the following 48 hours.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Post herpetic neuralgia
Clinical narrative: Shingles and PHN.
Age: 1.08
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Hyperaesthesia, Urticaria
Clinical narrative: The following morning after the vaccines, my daughter woke up with hives all over her body. We brought her into the doctor very concerned. The doctor waved it off and said that she was fine, give her some Benedryl, and it'd go away. We gave her doses of Benedryl over the next 24 hours. We saw zero improvement. The Benedryl was clearly not doing anything and we don't like to give our kids medications if they aren't doing any good and aren't needed. We instead switched to a more natural mindset. We hadn't connected yet that it was vaccine related but we knew that her body was desperately trying to detox through her skin. We gave her daily lemon essential oil baths and applying detox oils. Within about a week the hives started to subside but they didn't completely go away for two whole weeks after the vaccines. The initial hives did go away. She also started having extra sensitive skin after this event. Out of no where we had to choose even gentler options for our daughter. Now three years later, after a lot of detoxing, she can just barely start to handle things being applied to her skin again so she is just now starting to really recover - especially since we've connected the vaccine to the skin issues and started to take detoxing after the vaccines seriously.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Patient reported pain at the injection site and pain in her arm since the injection was given.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Fatigue, Headache, Hyperhidrosis
Clinical narrative: 12 hour throbbing headache, stomach cramps, arm muscle pain radiating down arm, tiredness, shivering, sweating off and on.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: 12 hour throbbing headache, stomach cramps, arm muscle pain radiating down arm, tiredness, shivering, sweating off and on.
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Full blood count normal, Haemoglobin normal, Injection site erythema, Injection site swelling
Clinical narrative: Diarrhea, 101° fever, vomiting, redness & swelling at the injection site.
Age: 1.17
Sex: F
Vaccine: VARCEL
Symptoms: Pyrexia, Vomiting
Clinical narrative: Diarrhea, 101° fever, vomiting, redness & swelling at the injection site.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Malaise, Pain in extremity, Pyrexia, Swelling
Clinical narrative: Patient reported fever of about 101 and general malaise plus soreness in injected arm on 3/23, then on 3/24 came to pharmacy and showed pharmacist a swollen, red area on the underside of the right arm (the arm in which he received injection). A physician at the emergency room diagnosed the area as possible cellulitis and prescribed clindamycin 300mg three times daily for 7 days.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site warmth, Malaise
Clinical narrative: Patient reported on 3/23/18 that had been sick in bed until this day, since the date of the vaccination on 3/20/18. Was fine prior to the vaccination. Also reported a very warm painful red area around the injection site that had not healed but also hadn't progressed for 2 days .
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Pruritus
Clinical narrative: The patient came into our pharmacy in the morning on 3/24/18 (the day after his first SHINGRIX injection) complaining of itching and sensitivity on his arms and back. The patient says the symptoms/reaction onset began in the late afternoon the day before on 3/23/18 after he arrived home from receiving the SHINGRIX injection. The patient says his wife had been rubbing over-the-counter hydrocortisone 1% cream on his back to try to help with the itching but that the area is very sensitive, so it is hard to allow her to rub the cream onto his skin. I told the patient to not use the hydrocortisone cream for now due to the sensitivity. The patient says he was not experiencing a rash, redness, hives, or problems breathing and that the area of itching and sensitivity appeared normal. I asked the patient if he took any pain medication such as TYLENOL or ibuprofen. The patient said he already takes ibuprofen for other body aches/pain. I asked to see the injection site, and it appeared normal with no rash, redness, swelling, etc. The patient said he could not think of anything else that would cause his itching. The patient asked if he should go to an urgent care/clinic since his doctor's office is closed for the weekend. I then asked the patient the severity of his reaction and he replied that he thinks it is severe. Since the patient replied severe, I instructed him to go see a doctor today (the day he came into the pharmacy complaining of the reaction). I will follow up with the patient tomorrow, 3-25-18, to see if he went to a clinic/urgent care and the outcome of the visit. I told the patient I will contact his primary care physician on Monday, 3/26/18, and that he should call his primary care doctor regarding the situation/treatment as well. The patient said he will follow-up with me on Monday, 3/26/18, after speaking with his doctor.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Neuralgia, Oedema peripheral
Clinical narrative: Foot edema, nerve pain.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Vaccine expiration of 3/2/2018 on vaccination date of 3/24/2018. Attempted to contact patient by phone. No answer, but left message for patient to call. We will revaccinate when patient is able to come back in.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Immediate post-injection reaction, Injection site erythema, Injection site irritation, Injection site pain
Clinical narrative: Patient came in to pharmacy today (3/24) complaining of reaction to the SHINGRIX vaccine she received on 3/18/2018. She said she had noticeable pain in her arm immediately following the injection. The following day, her entire torso was sore and she noticed considerable swelling around the site of injection. The body soreness only lasted about one day. The area affected is a 4" x 2" on the upper left arm, likely where the vaccine was administered.  It is warm to touch, very red, itchy, painful and slightly swollen; the patient reported that it was more swollen earlier in the week but seems to be improving. There was no exudate or visible wound/scars. Patient was self-treating with hydrocortisone cream and BENADRYL cream but was still having discomfort and came back to the pharmacy to report the adverse event. Since it has been improving over the past week (although the area is still very red and irritated a week later), she will be following up with her doctor on Monday and if it worsens, she is instructed to go to urgent care to be evaluated. No fever, difficulty swallowing or breathing. Reaction was localized to the area around vaccination site (with upper body/torso soreness for one day after).
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth, Pain, Pain in extremity
Clinical narrative: Patient came in to pharmacy today (3/24) complaining of reaction to the SHINGRIX vaccine she received on 3/18/2018. She said she had noticeable pain in her arm immediately following the injection. The following day, her entire torso was sore and she noticed considerable swelling around the site of injection. The body soreness only lasted about one day. The area affected is a 4" x 2" on the upper left arm, likely where the vaccine was administered.  It is warm to touch, very red, itchy, painful and slightly swollen; the patient reported that it was more swollen earlier in the week but seems to be improving. There was no exudate or visible wound/scars. Patient was self-treating with hydrocortisone cream and BENADRYL cream but was still having discomfort and came back to the pharmacy to report the adverse event. Since it has been improving over the past week (although the area is still very red and irritated a week later), she will be following up with her doctor on Monday and if it worsens, she is instructed to go to urgent care to be evaluated. No fever, difficulty swallowing or breathing. Reaction was localized to the area around vaccination site (with upper body/torso soreness for one day after).
Age: 1.0
Sex: M
Vaccine: HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Local reaction at vaccine site of PREVNAR 13 (redness and swelling).
Age: 76.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, C-reactive protein abnormal, Headache, Myalgia, Polymyalgia rheumatica
Clinical narrative: Patient reported being diagnosed with Polymyalgia Rheumatica. Signs started roughly 10 days after vaccination. Patient reported bilateral muscle/joint pain above the hips along with headaches. Patient has been treated with steroids (Prednisone).  As of today's date (3-24-18) patient reported that there is no longer the muscle and joint pain, but mild headaches continue.
Age: 27.0
Sex: M
Vaccine: ANTH
Symptoms: Discomfort, Injection site bruising, Injection site swelling, Pruritus
Clinical narrative: Bruise around injection 6 1/2 cm X 3 1/2 cm with swollen area around that measuring 8 1/2cm X 7 1/2cm. Pt reported pressure and slight itching.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Pyrexia
Clinical narrative: Chills and shivers about six hours after injection and experiencing flu like symptoms and fatigue that took almost 48 hours to recover from. Patient was only just feeling better when I spoke with him and he was informing me of his adverse effects.
Age: 62.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Influenza like illness
Clinical narrative: Chills and shivers about six hours after injection and experiencing flu like symptoms and fatigue that took almost 48 hours to recover from. Patient was only just feeling better when I spoke with him and he was informing me of his adverse effects.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: Swollen arm. Patient instructed to go to Urgent Care. She expressed she was 'ok for now' and would let us know if it gets worse but swelling started to go down.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Ill-defined disorder, Staring
Clinical narrative: Stiffness and staring for few minutes. Happened few times for few days since the day of vaccination.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Dyspnoea
Clinical narrative: Patient presented to the ER with shortness of breath found to be in Afib with RVR.
Age: 88.0
Sex: M
Vaccine: FLU4
Symptoms: Diarrhoea, Headache
Clinical narrative: Patient showed up to the pharmacy this Sunday morning 3/25/18 his chief complaint is diarrhea. No fever, slight headache, no body aches.
Age: 65.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: 2 to 3 days later pt reports that a red blistering rash spot appeared on inside of elbow right above & below the crease on left arm only. (Arm the shot was given) on 03-25 pt came in to show rash - about the size of a quarter above & below inside elbow crease. It looked blistered and red. Pt says it was itchy. No other symptoms reported- asked pt about possible exposure to poison ivy or other allergen, does not think had any other exposures. As of 03-25 pt still has rash.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Eye pain, Herpes zoster, Hypoaesthesia, Pain
Clinical narrative: Around 3 days after injection left scalp became numb but also painful to the touch. Spots of rash were present. On Day 5 spots of rash continued to left forehead and left eye experienced shooting pain. Blisters began forming around left eye. On Day 6 more pronounced blistering around left eye and the left eye again experiencing shooting pain. I went to the ER at Hospital where I was diagnosed with shingles.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pain of skin, Rash
Clinical narrative: Around 3 days after injection left scalp became numb but also painful to the touch. Spots of rash were present. On Day 5 spots of rash continued to left forehead and left eye experienced shooting pain. Blisters began forming around left eye. On Day 6 more pronounced blistering around left eye and the left eye again experiencing shooting pain. I went to the ER at Hospital where I was diagnosed with shingles.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blister, Eye pain, Herpes zoster, Ophthalmic herpes zoster, Rash
Clinical narrative: Around 3 days after injection left scalp became numb but also painful to the touch. Spots of rash were present. On Day 5 spots of rash continued to left forehead and left eye experienced shooting pain. Blisters began forming around left eye. On Day 6 more pronounced blistering around left eye and the left eye again experiencing shooting pain. I went to the ER at Hospital where I was diagnosed with shingles.
Age: 59.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Rash erythematous
Clinical narrative: Around 3 days after injection left scalp became numb but also painful to the touch. Spots of rash were present. On Day 5 spots of rash continued to left forehead and left eye experienced shooting pain. Blisters began forming around left eye. On Day 6 more pronounced blistering around left eye and the left eye again experiencing shooting pain. I went to the ER at Hospital where I was diagnosed with shingles.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Chills, Headache, Nausea, Pain
Clinical narrative: Patient experienced chills, body aches, mild fever, headache, nausea, and stomach pains. Resolved on its own within a couple days of rest.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient experienced chills, body aches, mild fever, headache, nausea, and stomach pains. Resolved on its own within a couple days of rest.
Age: 43.0
Sex: F
Vaccine: TDAP
Symptoms: Syringe issue
Clinical narrative: Pharmacist had difficulty getting the plunger to move further and upon removing the needle from the patient's arm to examine the syringe, noticed that there was an air bubble remaining in the syringe. There did not appear to be any more vaccine in the syringe, however, the patient did have a few (1-2 drops) of vaccine on her arm at the site of injection. Our clinical department was contacted and it was determined, based on ACIP recommendations, that the patient should be re-vaccinated. The patient was contacted and declined re-vaccination at this time.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Chills, Feeling abnormal, Influenza like illness, Injection site erythema
Clinical narrative: Patient reported having flu like symtpoms, fever chills, muscle aches in the shoulder and legs, stomach ache, feeling foggy, and redness around the site of injection.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Patient reported having flu like symtpoms, fever chills, muscle aches in the shoulder and legs, stomach ache, feeling foggy, and redness around the site of injection.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Hypersensitivity, Influenza like illness, Injection site erythema, Pain
Clinical narrative: Patient reported having flu like symtpoms, fever chills, muscle aches in the shoulder and legs, stomach ache, feeling foggy, and redness around the site of injection.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient reported having flu like symtpoms, fever chills, muscle aches in the shoulder and legs, stomach ache, feeling foggy, and redness around the site of injection.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local reaction, Pruritus, Skin warm, Swelling
Clinical narrative: Local reaction consisting of redness, swelling, tenderness, warmth to the touch, and slight itching.  Patient stated that the reaction started on the morning after the vaccine was administered. She notified me (RPh) two days later (Sunday, 3/25/2018). I told her to apply a cold compress to the area for 15 minutes, take an analgesic/anti-inflammatory if needed, and an antihistamine as needed. I advised her to contact her doctor tomorrow morning (Monday).
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Tenderness
Clinical narrative: Local reaction consisting of redness, swelling, tenderness, warmth to the touch, and slight itching.  Patient stated that the reaction started on the morning after the vaccine was administered. She notified me (RPh) two days later (Sunday, 3/25/2018). I told her to apply a cold compress to the area for 15 minutes, take an analgesic/anti-inflammatory if needed, and an antihistamine as needed. I advised her to contact her doctor tomorrow morning (Monday).
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: Patient called pharmacy sunday march 25th 2018. Pt stated she was experiencing redness and swelling at the injection site which continue down her arm to hand. Pt stated top of her hand had area of swelling about the size of a quarter along with redness. Pt stated redness started following day of time of injection ( tuesday march 20th 2018) but noticed the area sunday. Pt was unsure if area started at injection site and continued to spread down arm and to hand or if all redness/swelling happened simultaneously. I recommended she needed to seek medical attention from her primary doctor (which had given rx to pt).
Age: 5.0
Sex: F
Vaccine: MMR
Symptoms: Pyrexia, Vomiting
Clinical narrative: At 9:30 PM armpit temperature was 104F. At 9:35 PM oral temperature was 102.4F. At 9:45 PM Vomited. At 10:40 PM oral temperature was 104.2F. At 11:40 PM armpit temperature was 103.2F. Fever subsided and was gone within 24-48 hrs.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Insomnia, Pain, Skin warm
Clinical narrative: Cellulitis, warm, to touch, painful, couldn't sleep on iy.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Tendonitis
Clinical narrative: Tendonitis- pt recieved physical therapy. md suggested mri but patient declined due to cost.
Age: 61.0
Sex: F
Vaccine: HEPAB, PPV
Symptoms: Erythema, Feeling of body temperature change, Headache, Pain, Pain in extremity
Clinical narrative: PT. RECEIVED TWO VACCINES ON 3/23/18 AT APPROX. 11:36 AM. PT. CALLED PHARMACY DURING THE DAY ON 3/24/18 SEEKING RECOMMENDATION/ADVISE REGARDING HER LEFT ARM. PT. DESCRIBED HER ARM AS BEING RED, "GOOSE EGG" AND PAIN TRAVELING DOWN HER ARM. PT. HADN'T TRIED ANY OTC REMEDIES AND RPH RECOMMENDED BENADRYL ALONG WITH MONITORING WITH THE ASSUMPTION IF SYMPTOMS WORSEN TO SEEK MEDICAL ADVISE. PT. CALLED HER INSURANCE NURSE LINE ON EVENING OF 3/24/18 AND DESCRIBED SYMPTOMS AND THEY TOLD HER TO SEEK MEDICAL ATTENTION. PT. WAS SEEN IN THE ER AT HOSPITAL AND DIAGNOSED WITH AN INFECTION. PT. WAS GIVEN TWO PRESCRIPTIONS FOR ANTIBIOTICS. PT. FILLED THEM AT SAME WALMART AS VACCINES GIVEN AND SHOWED STAFF HER ARM. PT. WENT ON TO DESCRIBE HER SYMPTOMS AS FEELING HOT/COLD BACK AND FORTH, HEADACHE AND A SHOOTING/STABBING SHARP PAIN IN HER LEGS.
Age: 77.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Cellulitis, Contusion, Rash
Clinical narrative: Patient's wife called and claimed that she noticed a rash same as hers on the left arm. Patient had to go to urgent care and doctor suspected of cellulitis. Patient came in on 03/24/2018 and showed me the area, arm appeared to be bruised rather than a rash. Patient claims he takes COUMADIN.
Age: 35.0
Sex: M
Vaccine: ANTH
Symptoms: Erythema, Pallor, Skin warm
Clinical narrative: P/W LUE warmth, 24 1/2 x 20 cm area or blanching erythema, Pt given benadryl prn.
Age: 58.0
Sex: M
Vaccine: MMR, TDAP, TYP
Symptoms: Blister, Inflammation, Rash, Rash morbilliform, Rash pruritic
Clinical narrative: After the vaccines, a serious rash appeared on both legs. The rash is extremely inflamed and itches significantly. It looks like Measles and the rash has blisters that pop open and cause scabs when healing.
Age: 58.0
Sex: M
Vaccine: MMR, TDAP, TYP
Symptoms: Scab
Clinical narrative: After the vaccines, a serious rash appeared on both legs. The rash is extremely inflamed and itches significantly. It looks like Measles and the rash has blisters that pop open and cause scabs when healing.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Condition aggravated, Myalgia, Rash erythematous, Skin warm
Clinical narrative: Two adverse events: 1) I have paroxysmal atrial fibrillation. I go into AFib for more than a few seconds perhaps only one or twice a year. I went into AFib several hours after this (the second) SHINGRIX vaccination. I did not after the first. I have never had zoster.) 2) By 1 1/2 days post vaccination (starting this morning), I had a tender erythematous rash at the vaccination site and extending several centimeters away. One red lesion, not multiple. Very well defined (sharp) border with normal skin. Warm to touch. Only very slightly raised. No vesicles. Underlying arm muscle is sore, but only to an expectable degree (not overly).
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccination site pain, Vaccination site reaction
Clinical narrative: Two adverse events: 1) I have paroxysmal atrial fibrillation. I go into AFib for more than a few seconds perhaps only one or twice a year. I went into AFib several hours after this (the second) SHINGRIX vaccination. I did not after the first. I have never had zoster.) 2) By 1 1/2 days post vaccination (starting this morning), I had a tender erythematous rash at the vaccination site and extending several centimeters away. One red lesion, not multiple. Very well defined (sharp) border with normal skin. Warm to touch. Only very slightly raised. No vesicles. Underlying arm muscle is sore, but only to an expectable degree (not overly).
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Herpes zoster
Clinical narrative: I had the SHINGRIX vaccine and one day after I received the first injection, I contracted shingles. My whole left side was extremely tender and I had blisters on the left side of my back. I previously had the ZOSTAVAX with no issues. Needless to say, I am foregoing the second SHINGRIX vaccine. I reported this to GSK.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Musculoskeletal chest pain
Clinical narrative: I had the SHINGRIX vaccine and one day after I received the first injection, I contracted shingles. My whole left side was extremely tender and I had blisters on the left side of my back. I previously had the ZOSTAVAX with no issues. Needless to say, I am foregoing the second SHINGRIX vaccine. I reported this to GSK.
Age: 74.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blister, Herpes zoster, Incomplete course of vaccination, Tenderness
Clinical narrative: I had the SHINGRIX vaccine and one day after I received the first injection, I contracted shingles. My whole left side was extremely tender and I had blisters on the left side of my back. I previously had the ZOSTAVAX with no issues. Needless to say, I am foregoing the second SHINGRIX vaccine. I reported this to GSK.
Age: 0.33
Sex: U
Vaccine: HPV9, PNC13, RV5, HPV9
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a physician and the patient's mother referring to a 4 month old patient of unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 22-MAR-2018, the patient was inadvertently vaccinated with GARDASIL 9 lot number: N022727, expiration date: 12-JUN-2020, for prophylaxis (strength, route and dosage schedule were not reported). No adverse effects were reported.
Age: 0.33
Sex: U
Vaccine: HPV9, PNC13, RV5, HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a physician and the patient's mother referring to a 4 month old patient of unknown gender. The patient's relevant medical history, drug reactions/allergies and concomitant medication were not reported. On 22-MAR-2018, the patient was inadvertently vaccinated with GARDASIL 9 lot number: N022727, expiration date: 12-JUN-2020, for prophylaxis (strength, route and dosage schedule were not reported). No adverse effects were reported.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Injection site erythema, Injection site pain, Injection site swelling, Lymphadenopathy
Clinical narrative: Swollen glands, fever, joint and muscle pain, injection site swelling, redness and pain, lasted about 3 days.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Myalgia, Pyrexia
Clinical narrative: Swollen glands, fever, joint and muscle pain, injection site swelling, redness and pain, lasted about 3 days.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pain
Clinical narrative: Aches, pain, and fatigue which lasted for approximately 14 hours.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Asthenia, Injection site erythema, Injection site induration, Injection site swelling, Myalgia
Clinical narrative: Patient had negative reaction to anthrax vaccine SEPT 2017. This nurse noted reaction but it was recorded in EMR as patient did not go to HP. Lasting for approx 1 week, rash about 15 inches from shoulder to forearm, swollen around circumference of shot, area reddened and hardened. Patient felt week and myalgia lasting one week. Recommend patient not receive Anthrax vaccine in future.
Age: 30.0
Sex: M
Vaccine: ANTH
Symptoms: Rash, Vaccination complication
Clinical narrative: Patient had negative reaction to anthrax vaccine SEPT 2017. This nurse noted reaction but it was recorded in EMR as patient did not go to HP. Lasting for approx 1 week, rash about 15 inches from shoulder to forearm, swollen around circumference of shot, area reddened and hardened. Patient felt week and myalgia lasting one week. Recommend patient not receive Anthrax vaccine in future.
Sex: F
Vaccine: PPV
Symptoms: Adverse event, Injection site pain, Malaise
Clinical narrative: This report has been received from the consumer reporting of herself, a female of approximately 67 years old who is enrolled in a study. This report was received via Regulatory Authority. The patient's relevant medical history included a malignant lung neoplasm as concurrent condition, for which the patient was under concomitant treatment with KEYTRUDA. Further information about the patient's medical history and concurrent conditions was not provided. It was also unknown if the patient was taking other concomitant therapies. The patient reported that, on an unknown date, she was vaccinated with an unspecified pneumococcal vaccine for prophylaxis, considering that "any respiratory illness" would "exacerbate" her lung cancer. The patient could not confirm whether or not she received PNEUMOVAX 23 (suspect product trade name, formulation, dose, route and anatomical site of administration were not known). The patient reported that, on an unknown date, the vaccine "made her sick". Also, she stated that she was "terrible sore" at the injection site for 3 days and, that on day 5 after vaccine was administered, she "got the not so common side effects". Finally, she mentioned that it was a good idea to get the vaccination, but awareness was needed of the potential side effects. Information regarding the diagnostic test carried out for diagnosis, or any other, regarding the events was not provided. By the time of the report, the outcome for the patient from the events was unknown. The reporter considered the events to be related to Pneumococcal Vaccine, Polyvalent (23-valent) (manufacturer unknown). Upon internal clarification, the report type was updated to spontaneous as Pneumococcal Vaccine Polyvalent (23-valent) (manufacturer unknown) was not part of the Market research.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Constipation, Diarrhoea, Erythema, Immediate post-injection reaction, Pyrexia
Clinical narrative: This spontaneous report was received from registered nurse referring to her daughter a female patient of 4 months old. The patient did not have pertinent medical history, drug reactions or allergies. No laboratories were performed. On 05-DEC-2017 the patient was vaccinated with the first dose of ROTATEQ, orally for prophylaxis (dose, frequency, lot number and expiration date were not reported). No side effects were reported after getting the first dose. Approximately on 14-FEB-2018 the patient was vaccinated with the second dose of ROTATEQ, orally for prophylaxis (dose, frequency, lot number and expiration date were not reported) and immediately after getting the second dose experienced "diarrhea and constipation". The mother stated that on the night she received the vaccination, and a few days ago, she also had a low grade fever  which she thought might be related to the ROTATEQ and furthermore on an unspecified date in 2018, the patient developed "a little redness on her cheeks near her lips and red patches around her chest." The mother also noted that her daughter was vaccinated concomitantly with "3 or 4 other vaccines" (product names unspecified) the same day she was administered with ROTATEQ as well. The mother said she was concerned that her daughter's symptoms had continued on since administration of the vaccine 3 weeks ago. No treatment was given for the adverse events, and no laboratory diagnostic studies were performed. The patient sought unspecified medical attention. The outcome of the events was reported as not recovered. Causality assessment for Erythema, Diarrhoea and Constipation was not provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse concerning a patient of unknown age and gender. There was no information about the patient's concurrent conditions, medical history or concomitant medication. On an unknown date, the patient was vaccinated with VARIVAX intramuscularly, lot # N022980 with expiration date of 23-AUG-2019, (dose and anatomical location were not reported) for prophylaxis. No adverse effects were reported.
Age: 73.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: This spontaneous report was received from a 73 year old female patient. The patient's current conditions included unspecified heart condition and penicillin allergy. Historical medication included penicillin. Concomitant medication included amlodipine and aspirin (manufacturer unknown). On 19-MAR-2018, the patient was administered PNEUMOVAX 23 (lot and expiry date not reported) to prevent pneumonia. The patient experienced a fever and fatigue after receiving a PNEUMOVAX 23 on 19-MAR-2018. The patient also experienced pain and soreness on the opposite arm of the injection. The patient described the feeling as "hot to touch". The patient saw physician and took unspecified treatment for the events. Outcome of the events was not recovered. Causality assessment was not reported for the events.
Age: 8.0
Sex: M
Vaccine: PPV
Symptoms: Asthenia, Decreased appetite, Fatigue, Pain in extremity, Pyrexia
Clinical narrative: High fever within hr of giving shot. Fevers ranged from 103.7 to 104.2 over a 48 hr period. Complained of a lot of arm pain and weakness. Also very tired and no appetite over this time period. Hydrated with Gatorade and cooled down fever with ice chips and cool compresses.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Headache, Nausea, Pain, Pyrexia
Clinical narrative: Fever (101) headache, shaking, body aches, nausea, vomiting, diarrhea lasting three days.
Age: 33.0
Sex: F
Vaccine: VARZOS
Symptoms: Tremor, Vomiting
Clinical narrative: Fever (101) headache, shaking, body aches, nausea, vomiting, diarrhea lasting three days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Cellulitis, Pain, Secretion discharge, Skin lesion, Skin warm
Clinical narrative: Does not itch, hurts. Several hours later after vaccines, noted swelling and child was complaining of pain. Denies fevers. Denies other trauma. Lesions (raised lesion, straw colored drainage hot to touch, tender, measuring 3cm X 3cm. No streaking. No inguinal lymph node swelling). Treated as Cellulitis with Cephalexin 250 mg/5 mL oral suspension - Take 3 mL twice a day by oral route with meals for 10 days. Follow up scheduled 3/26/18.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Swelling, Tenderness
Clinical narrative: Does not itch, hurts. Several hours later after vaccines, noted swelling and child was complaining of pain. Denies fevers. Denies other trauma. Lesions (raised lesion, straw colored drainage hot to touch, tender, measuring 3cm X 3cm. No streaking. No inguinal lymph node swelling). Treated as Cellulitis with Cephalexin 250 mg/5 mL oral suspension - Take 3 mL twice a day by oral route with meals for 10 days. Follow up scheduled 3/26/18.
Age: 54.0
Sex: F
Vaccine: HEP, VARCEL
Symptoms: Injection site erythema, Injection site papule, Injection site pruritus, Injection site rash
Clinical narrative: Redness and itching to administration site. Quarter size area w/sm papules/bumps.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Back pain, Exposure during pregnancy, Musculoskeletal pain, Nausea
Clinical narrative: Client received TDAP on 03/21/2018 @ 30 weeks gestation. She had received a previous TDAP on 08/14/2017. Client called in the am of 03/22/2018 with C/O pain in her shoulder and back with some nausea. She stated she might have had a fever but did not check herself. I encouraged her to contact her OB/GYN for instructions. Client did contact and was advised to rest and drink plenty of fluids. I F/U with her today at 09:15 am and she said she was much better in the afternoon of 03/22/2018.
Age: 1.33
Sex: F
Vaccine: DTAP, HIBV, PNC13
Symptoms: Dyskinesia
Clinical narrative: Parent states patient has experienced whole body jerking since the immunizations were given but just reported it on March 24, 2018.
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Chills, Pain, Pyrexia, Restlessness, Vaccination complication
Clinical narrative: 12 hours after receive vaccination Pt reports that she had fever 103 F. "I got a really bad reaction to the rabies booster, that night my whole body ached and I had a fever (103) and chills and spent all night tossing and turning from the chills and fever combo". Symptoms resolved in 12 hours. Pt took two NYQUIL - 325mg of acetaminophen.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a Licensed Practical Nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, concomitant medications, and historical drugs were not reported. On 06-FEB-2018, the patient was vaccinated with an improperly stored dose of PROQUAD with lot # reported as N042500 (expiration date unknown) (Strength, route, dose, frequency, and anatomical location were unknown) for prophylaxis, reconstituted with sterile diluent (MERCK) that was properly stored. There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 6°F to 14°F degrees Fahrenheit for 158 hours 39 minutes and 15°F to 46°F degrees Fahrenheit for 343 hours 29 minutes. There was a digital data logger involved, but there was no previous temperature excursion. This is one of several reports received from the same reporter. Lot number N042500 is an invalid lot number for measles, mumps, rubella and varicella (oka-merck) virus vaccine live; Sender's Comments: US-009507513-1803USA006483.