chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Angioedema, Chemotherapy, Pain, Psychotic disorder, Pyrexia
Clinical narrative: Angioedema; psychosis; Body aches; Fever; This case was reported by a nurse via sales rep and described the occurrence of angioedema in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included cancer.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a day after receiving Shingrix, the patient experienced angioedema (serious criteria GSK medically significant), psychosis, pain and fever. The patient was treated with chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the angioedema, psychosis, pain and fever were unknown.   It was unknown if the reporter considered the angioedema, psychosis, pain and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The doctor advised the patient who was undergoing chemotherapy to receive Shingrix with the approval of her oncologist. It was reported that, within several hours 1 to 2 hours, after receiving Shingrix, the patient experienced body aches and fever. The patient also experienced angioedema and psychosis for a period.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm soreness; 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 Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included ibuprofen for an unknown indication.   On 19th August 2019, the patient received the 1st dose of Shingrix. On an unknown date, the patient started ibuprofen at an unknown dose and frequency. On 19th August 2019, less than a day after receiving Shingrix, the patient experienced pain in arm. The action taken with ibuprofen was unknown. On an unknown date, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingrix.  Additional case details were provided as follows: The patient received the dose of shingrix and experienced the sore arm in the injected arm. The reporter did not consent to follow up. This case has been linked to US2019196456 reported by same reporter for the same patient for the 2nd dose.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Chills; Fever; Headache; Body ache; Vomiting; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (sore arm after receiving 1st dose on 19th August 2019, see case US2019AMR197056). Concomitant products included ibuprofen.   On 28th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On 28th October 2019, the patient experienced vomiting. On 29th October 2019, the patient experienced chills, fever, headache and general body pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vomiting, chills, fever, headache, general body pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the vomiting, chills, fever, headache, general body pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient experienced vomiting, body aches, chills, fever, headace, and a sore arm. 8 hours after vaccination patient experienced vomiting. One day after vaccination patient experienced chills, fever, headache and general body pain. The patient did not consent to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge, Vomiting
Clinical narrative: Chills; Fever; Headache; Body ache; Vomiting; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of vomiting in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (sore arm after receiving 1st dose on 19th August 2019, see case US2019AMR197056). Concomitant products included ibuprofen.   On 28th October 2019, the patient received the 2nd dose of Shingrix. In October 2019, less than a week after receiving Shingrix, the patient experienced pain in arm. On 28th October 2019, the patient experienced vomiting. On 29th October 2019, the patient experienced chills, fever, headache and general body pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the vomiting, chills, fever, headache, general body pain and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the vomiting, chills, fever, headache, general body pain and pain in arm to be related to Shingrix.  Additional details were provided as follows: The patient experienced vomiting, body aches, chills, fever, headace, and a sore arm. 8 hours after vaccination patient experienced vomiting. One day after vaccination patient experienced chills, fever, headache and general body pain. The patient did not consent to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Amnesia, Dizziness, Fatigue, Nausea, Pyrexia
Clinical narrative: Transient global amnesia; short term memory loss; fever; nausea; fatigue; dizziness; This case was reported by a consumer via call center representative and described the occurrence of transient global amnesia in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced fever, nausea, fatigue and dizziness. On 24th October 2019, the patient experienced transient global amnesia (serious criteria hospitalization) and short-term memory loss (serious criteria hospitalization). In October 2019, the outcome of the fever, nausea and fatigue were recovered/resolved. On 26th October 2019, the outcome of the transient global amnesia and short-term memory loss were recovered/resolved. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the transient global amnesia, short-term memory loss, fever, nausea, fatigue and dizziness to be related to Shingrix.  Additional details were provided as follows: Seven days after vaccination, the patient experienced short term memory loss and was admitted to hospital for observation and was diagnosed with transient global amnesia (TGA). The patient was discharged on 26th October 2019. Less than 2 weeks after vaccination, the patient expereinced some dizziness. The reporter consented to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Transient global amnesia
Clinical narrative: Transient global amnesia; short term memory loss; fever; nausea; fatigue; dizziness; This case was reported by a consumer via call center representative and described the occurrence of transient global amnesia in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 17th October 2019, the patient received the 2nd dose of Shingrix (intramuscular). In October 2019, less than a week after receiving Shingrix, the patient experienced fever, nausea, fatigue and dizziness. On 24th October 2019, the patient experienced transient global amnesia (serious criteria hospitalization) and short-term memory loss (serious criteria hospitalization). In October 2019, the outcome of the fever, nausea and fatigue were recovered/resolved. On 26th October 2019, the outcome of the transient global amnesia and short-term memory loss were recovered/resolved. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the transient global amnesia, short-term memory loss, fever, nausea, fatigue and dizziness to be related to Shingrix.  Additional details were provided as follows: Seven days after vaccination, the patient experienced short term memory loss and was admitted to hospital for observation and was diagnosed with transient global amnesia (TGA). The patient was discharged on 26th October 2019. Less than 2 weeks after vaccination, the patient expereinced some dizziness. The reporter consented to follow up.
Age: 85.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Mobility decreased, Pain
Clinical narrative: Extreme chills.  Aching all over.  Unable to get out of bed for three days because of the pain and chills.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Shoulder injury related to vaccine administration
Clinical narrative: Patient said vaccination was more painful than other vaccines she had taken. The pain decreased a little over the next few days, but persisted after weeks. Enough that patient went to her primary doctor and was diagnosed with sirva.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Developed Redness, tenderness, and localized swelling of the left upper arm over Deltoid area. Reddened area was warm to touch and measured  7cmx7cm. Evaluated by Dr on 10/30/2019 . instructed to ice the area and take over the counter Ibuprofen if there is discomfort. Seen again by Dr 10/31, decreased size of reddened area, no fever, , decreased swelling. Determined no further need for treatment or surveillance unless S/S worsened.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Patient began feeling feverish the day after vaccine with last temp taken being 100.2 F
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Cold sweat, Face injury, Face oedema, Fall
Clinical narrative: The patient wrote out a letter describing what happened to her.  She brought it to us at the pharmacy on 11/2/19.  Here's what she wrote: "Saturday, October 26th.  Normal day out and about running errands.  That evening took 1.5 hour ride to visit with family.  It was on the way home that I started to feel achy and tired.  Went to bed around 10pm. Around 3am, Sunday morning, I woke up and needed to go to the bathroom.  My hips ached and were tight - hard to move.  Rolled to my side and put my feet on the floor.  Once I stood up the pain was very bad.  The pain went up my entire body.  Tried to sit on the steps beside the bed.  Still very painful.  My husband woke up to help me.  Tried to turn and get back into bed and slid down the bed and hit my face on the bedside table.  It didn't bruise, but it hurt.  My husband got me up and I was in so much pain I started getting sweaty and clammy.  I couldn't explain what was going on.  He wanted to call an ambulance, but I didn't.  I told him I would get through this.  He helped me back in the bed.  I tried to stretch out the pain.  Finally able with his assistance was able to go to the bathroom.  Hard to sit down and then stand back up.  Finally able to go back to sleep. 9am Sunday morning (Oct 27th).  Tired, but able to move on my own.  Did stretches throughout the day to work it out.  Monday through Wednesday - ached some in the morning but throughout each day it would get better the more i moved.  Thursday and Friday I had little to no weird feelings.   Saturday November 2nd, 2019.  Woke up felt great.  Can't explain what caused this but scary."
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Hyperhidrosis, Mobility decreased, Pain
Clinical narrative: The patient wrote out a letter describing what happened to her.  She brought it to us at the pharmacy on 11/2/19.  Here's what she wrote: "Saturday, October 26th.  Normal day out and about running errands.  That evening took 1.5 hour ride to visit with family.  It was on the way home that I started to feel achy and tired.  Went to bed around 10pm. Around 3am, Sunday morning, I woke up and needed to go to the bathroom.  My hips ached and were tight - hard to move.  Rolled to my side and put my feet on the floor.  Once I stood up the pain was very bad.  The pain went up my entire body.  Tried to sit on the steps beside the bed.  Still very painful.  My husband woke up to help me.  Tried to turn and get back into bed and slid down the bed and hit my face on the bedside table.  It didn't bruise, but it hurt.  My husband got me up and I was in so much pain I started getting sweaty and clammy.  I couldn't explain what was going on.  He wanted to call an ambulance, but I didn't.  I told him I would get through this.  He helped me back in the bed.  I tried to stretch out the pain.  Finally able with his assistance was able to go to the bathroom.  Hard to sit down and then stand back up.  Finally able to go back to sleep. 9am Sunday morning (Oct 27th).  Tired, but able to move on my own.  Did stretches throughout the day to work it out.  Monday through Wednesday - ached some in the morning but throughout each day it would get better the more i moved.  Thursday and Friday I had little to no weird feelings.   Saturday November 2nd, 2019.  Woke up felt great.  Can't explain what caused this but scary."
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Contusion, Dysphonia, Injection site pain, Joint range of motion decreased, Nasal congestion
Clinical narrative: The injection hurt significantly as it was given through a band aid. I had bruising on my arm and pain for several days. Now my arm is still sore and my range of motion using that shoulder is limited and quite painful with reaching movements.  My voice began to be affected with hoarseness and at times it has been difficult to talk. My voice still squeaks and I can?t get volume as I speak. I understand I was given high dose vaccine grown on eggs. This is the only time I? e had a reaction following a flu shot.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: The injection hurt significantly as it was given through a band aid. I had bruising on my arm and pain for several days. Now my arm is still sore and my range of motion using that shoulder is limited and quite painful with reaching movements.  My voice began to be affected with hoarseness and at times it has been difficult to talk. My voice still squeaks and I can?t get volume as I speak. I understand I was given high dose vaccine grown on eggs. This is the only time I? e had a reaction following a flu shot.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Aphonia, Arthritis, Dysphonia, Injection site bruising, Pain
Clinical narrative: The injection hurt significantly as it was given through a band aid. I had bruising on my arm and pain for several days. Now my arm is still sore and my range of motion using that shoulder is limited and quite painful with reaching movements.  My voice began to be affected with hoarseness and at times it has been difficult to talk. My voice still squeaks and I can?t get volume as I speak. I understand I was given high dose vaccine grown on eggs. This is the only time I? e had a reaction following a flu shot.
Age: 76.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Weight bearing difficulty
Clinical narrative: The injection hurt significantly as it was given through a band aid. I had bruising on my arm and pain for several days. Now my arm is still sore and my range of motion using that shoulder is limited and quite painful with reaching movements.  My voice began to be affected with hoarseness and at times it has been difficult to talk. My voice still squeaks and I can?t get volume as I speak. I understand I was given high dose vaccine grown on eggs. This is the only time I? e had a reaction following a flu shot.
Age: 24.0
Sex: F
Vaccine: FLU3
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient came in to get a flu shot. She is 24 years old, so she should have gotten the Fluzone Quad. I mistakenly gave her the Fluzone HD. I personally spoke to her provider, PA and her supervisor, Dr. They indicated that she may experience increased side effects, but that was it. I called the patient personally and let her know what happened as well as repeated my conversation with PA and Dr. I reassured her that she would be fine, but may exhibit increased side effects (headache, pain at injection site, fever, redness at injection site.
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Hypoaesthesia oral, Paraesthesia oral, Tremor
Clinical narrative: Patient felt fine but stressed prior to vaccination of shot. Family going through medical trouble and talking about house burning down during vaccine (anxiety trigger in her past). Other than stress, patient was ok. Gave patient Boostrix. Administration went according to protocol. Asked patient to sit for 15 minutes and she started reporting dizziness and hand tremor. Asked patient to lay down and she refused. Asked if mouth felt tingling or swelling and it did not at first. I suggested she take one of her anxiety alprazolam to relax. Patient started getting more stressed as we talked and then reported her lips started to feel tingly. She reported half of her tongue does go numb when she smells certain smells. I stated that we do have many different scents in our store as we are a gift store. I asked if she would like me to call 911 as her mouth was starting to tingle and I stated I would prefer her have a reaction in the ER (1 block away) than in our store so she could get proper medical treatment. She refused. I asked if I could get her husband here and went out to their truck and informed husband of the situation. He came in and drove her to the ER. Prior to them leaving, I contacted the local ER and gave them a rundown of the events leading up to their admission. Followed up with clinic every hour times 2 when patient was sent home. She received benadryl IV and relaxed. Dr did not report anaphylaxis.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site reaction, Myalgia
Clinical narrative: Muscle soreness in arm (non-dominant arm) where vaccine received that started on 11/4/19 (18 days post-vaccination) that feels like normal/expected soreness that was experienced/is expected to be experienced in days immediately following vaccination. At time of this report on 11/5/19, soreness persists. No strenuous activity has occurred that would be expected to cause this.
Age: 16.0
Sex: M
Vaccine: FLU3, HPV9, MNQ
Symptoms: Contusion, Headache, Nausea
Clinical narrative: Patient received 3 vaccines today.  Patient was feeling nauseated post injection and went to restroom.  Patient was found on the restroom floor with a small contusion to the poster head.  Patient was transferred to the treatment room via wheel chair.  Patient was alert and oriented to person, place and time.  Patient rated pain to head a 3/10.  Ice pack applied to head.  Vital signs obtained were normal.  Patient was observed and released by PA.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Palpitations, Throat tightness
Clinical narrative: PT STATED HER THROAT WAS CLOSING OFF AND HER HEART WAS BEATING "BOOM BOOM" AFTER SHE GOT HER FIRST SHINGLES SHOT AND A FLU SHOT.  PT HAD HER DGTR DRIVE HER BACK TO THE PHARMACY. AT THIS TIME, PT DID REPORT A HISTORY OF PANIC ATTACKS WITH MRI'S AND OTHER SITUATIONS. WE MONITORED PT FOR 30 MINUTES, TAKING BLOOD PRESSURES AND HEART RATES. PT'S STATUS RESOLVED AND PT LEFT THE PHARMACY (daughter driving) AFTER PULSE <100 TIMES 2 AND BLOOD PRESSURE LESS THAT 140/90 TIMES TWO.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Deafness, Dizziness, Hyperhidrosis, Vision blurred
Clinical narrative: Pt was weak, diaphoretic, lightheaded, loss of hearing, blurred vision.  RN had pt lay on the floor, BP 120/88, Pulse 88. RN gave pt 0.5mL of Epinephrine and called 911. at 1400. Pt BP 128/60 and oulse 90 at 1410. Paramedics arrived at 1415.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Blood pressure decreased, Blood test normal, Cardiac stress test normal, Chest X-ray normal
Clinical narrative: lump in throat, dizzy, pressure in upper chest and back, chills, blood pressure dropped, sick to my stomach and feeling so weak. It started about 4 hours after the shot about 2:30 PM October 1, 2019.   Went to Emergency Dept
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Computerised tomogram normal, Dizziness, Electrocardiogram normal
Clinical narrative: lump in throat, dizzy, pressure in upper chest and back, chills, blood pressure dropped, sick to my stomach and feeling so weak. It started about 4 hours after the shot about 2:30 PM October 1, 2019.   Went to Emergency Dept
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling abnormal, Sensation of foreign body
Clinical narrative: lump in throat, dizzy, pressure in upper chest and back, chills, blood pressure dropped, sick to my stomach and feeling so weak. It started about 4 hours after the shot about 2:30 PM October 1, 2019.   Went to Emergency Dept
Age: 34.0
Sex: F
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Dose given too early after 1st dose
Age: 42.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Myalgia, Pain
Clinical narrative: Patient started having pain in his upper L shoulder around 11/2/19. He only notices pain when he tries to lift his left arm. Once it gets to shoulder height he starts to have pain in the arm. Patient hasn't noticed any tingling, burning, etc. no radiating pain. Patient has taken 800mg of advil and it helped "somewhat" but still had pain. Patient hasn't been seen by MD yet. Patient had normal muscle soreness 1-2 days after shot, then no pain then about 11/2/19 started having upper shoulder pain
Age: 24.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site reaction, Injection site swelling, Pain
Clinical narrative: Burning pain below site of injection. Red and puffy below site of injection; seen at ER and given an oral liquid steroid to treat
Age: 63.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Hypersensitivity, Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Patient presented with redness, warmth, itching and pain to L deltoid a couple hrs after PPSV 23 on 11/1/19. Redness increased in size over weekend. She treated with ASA, naproxen and ice which did not relieve pain. Triaged situation 11/4/19, appt 11/5/19, patient states seems to be getting better this morning. Provider assessed reaction and felt this was an  allergic response to immunization. Will monitor and f/u in two days for re-evaluation. No medications prescribed.
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Injection site induration, Injection site pruritus, Injection site swelling, Irritability, Lethargy
Clinical narrative: Swelling of the leg, itching, hardness at injection site. Fever. Irritable. Lethargic
Age: 3.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: Swelling of the leg, itching, hardness at injection site. Fever. Irritable. Lethargic
Age: 68.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: 10-12 cm area raised, red, and ached at site of injection (left arm - flu vaccine) 36-48 hours until improvement
Age: 31.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Peripheral swelling, Reaction to preservatives, Skin warm
Clinical narrative: Pt says she has a swollen, warm red area on her arm below the injection site.  She was concerned and went to the local clinic where they told her she was having an allergic reaction to the preservatives in the Flublok she had given the day before
Age: 49.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Chills, sweating,  muscle aches, fever, headache
Age: 78.0
Sex: M
Vaccine: PNC13
Symptoms: Contusion, Injection site nodule, Pain
Clinical narrative: There is approximately a 3 inch X 3 inch bruised area.  The patient had very bad soreness originally and bruising.  On 11-5-19, the patient said the bruising was not as severe and not sore any more. He said he still had a knot at the injection site.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: red, warm, swollen at the injection site
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Mass, Pain in extremity
Clinical narrative: "Baseball sized pink lump, arm pain, "
Age: 38.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Chills, Erythema, Hypersensitivity, Nausea, Pain in extremity
Clinical narrative: presents with c/o R arm pain redness and allergic reaction to flu or PNA shot. Received on Friday 11/1/19, then subsequntly had + fever nausea, chills, "sick in bed all day". Had ibuprofen, improves pain and fevers, swelling, and has significantly improved from yesterday. Pt looked up reactions on the internet and feels that is what happened. Denies difficulty breathing, n/v/d, chest pain, or sob.
Age: 38.0
Sex: F
Vaccine: FLU4, UNK
Symptoms: Pyrexia, Swelling
Clinical narrative: presents with c/o R arm pain redness and allergic reaction to flu or PNA shot. Received on Friday 11/1/19, then subsequntly had + fever nausea, chills, "sick in bed all day". Had ibuprofen, improves pain and fevers, swelling, and has significantly improved from yesterday. Pt looked up reactions on the internet and feels that is what happened. Denies difficulty breathing, n/v/d, chest pain, or sob.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Inappropriate schedule of product administration, Influenza like illness, Pyrexia
Clinical narrative: inappropriate schedule of; fever; shivering; headache; flu lkie; This case was reported by a consumer via call center representative and described the occurrence of fever in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (for tolerance of 1st dose refer case US2019197560 ).   On 20th August 2019, the patient received the 2nd dose of Shingrix. On 20th August 2019, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On an unknown date, the patient experienced fever, shivering, headache and influenza-like symptoms. On an unknown date, the outcome of the fever, shivering, headache and influenza-like symptoms were recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the fever, shivering, headache and influenza-like symptoms to be related to Shingrix.  Additional details were provided as follows:  The patient received 2nd dose late than recommended interval, which led to lengthening of vaccination schedule. After receiving 2nd dose, the patient experienced flu-like symptoms, fever, shivering and headache. These resolved after 5 days. Consent to follow up was given. This was 1 of the 4 cases reported by same reporter.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Arm pain; Neck pain; This case was reported by a pharmacist via call center representative and described the occurrence of pain in arm in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number BP57E, expiry date 7th December 2021) for prophylaxis.   On 7th September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, less than 2 months after receiving Shingrix, the patient experienced pain in arm and neck pain. On an unknown date, the outcome of the pain in arm and neck pain were unknown.   It was unknown if the reporter considered the pain in arm and neck pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in unknown arm. Since receiving the vaccine patient experienced arm pain that was radiating up to the neck from injection site. No further details were provided. The reporter consent to follow up.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Urticaria
Clinical narrative: rash spread from this foot to both legs; hives/ welts; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number 252N2, expiry date 8th March 2020) for prophylaxis.   On 28th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 29th October 2019, 1 days after receiving Shingrix, the patient experienced rash and hives. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the rash was recovered/resolved and the outcome of the hives was unknown.   It was unknown if the reporter considered the rash and hives to be related to Shingrix.   Additional details were received as follows: The reporter stated that the patient after vaccination developed a rash on his foot and the rash spread from this foot to both legs and the rash consisted of hives and welts. The patient went to the ER and received Benadryl, which cleared up the rash.
Sex: U
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site inflammation, Injection site swelling
Clinical narrative: reaction at the injection site that consisst of swelling and redness bigger than the size of a quarter; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves five patients who experienced reaction at the injection site that consist of swelling and redness bigger than the size of a quarter (inflammation), while he/she received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patients received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot number not reported via unknown route in unknown administration site.  On an unknown date, the patients developed a non-serious reaction at the injection site that consist of swelling and redness bigger than the size of a quarter (inflammation) (Unknown latency) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  Lab data was not reported.  Final diagnosis was inflammation.   It was not reported if the patient received a corrective treatment.  The patient outcome was reported as unknown for inflammation.  Information on the batch number was requested.
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: redness, warmth, and swelling to her injection site; redness to her injection site; warmth to her injection site; swelling to her injection site; itching to her injection site; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 73 years old female patient who experienced redness, warmth, and swelling to her injection site (vaccination site inflammation), itching to her injection site (vaccination site pruritus), redness to her injection site (vaccination site erythema), warmth to her injection site (vaccination site warmth) and swelling to her injection site (vaccination site swelling), while she received vaccine DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient was postmenopausal.   On 21-Oct-2019, the patient received a 0.5 ml dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot: U6512AA, expiry date: 23-Oct-2021) via intramuscular route in the left deltoid.  On an unknown date, the patient developed a non-serious redness, warmth, and swelling to her injection site (vaccination site inflammation), itching to her injection site (vaccination site pruritus), redness to her injection site (vaccination site erythema), warmth to her injection site (vaccination site warmth) and swelling to her injection site (vaccination site swelling) (Unknown latency) following the administration of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE.  Lab data was not reported.  Final diagnosis was itching to her injection site and redness, warmth, and swelling to her injection site.   The patient was treated with 10 mg/mL triamcinolone intramuscular in the left hip and a prescription for prednisone 20 mg by mouth daily for 7 days.  The patient outcome was reported as unknown for all the events.
Age: 1.25
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, No adverse event
Clinical narrative: expired dose of Daptacel was given to patient/ No AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 15 months old male patient who received expired vaccine DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE [DAPTACEL].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for Immunisation; and HIB VACCINE CONJ (TET TOX) (ACT-HIB) for Immunisation.  On 29-Oct-2019, the patient received fourth 0.5 mL dose of suspect DIPHTHERIA-15/TETANUS/5 AC PERTUSSIS VACCINE lot C5307AA, expiry date-23-Oct-2019 via intramuscular route in the right vastus lateralis.  It was a case of actual medication error due to expired vaccine used.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive and Module VI of the Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 37.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Fluzone HD was accidentally given to a 37 year old patient, no AE; Fluzone HD was accidentally given to a 37 year old patient, no AE; came to a Flu Shot Clinic yesterday and were inadvertently given a Fluzone HD; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from other health professional.  This case is linked to case 2019SA303332 (same reporter).  This case involves a 37 years old female patient who received a 0.5 ml dose of vaccine INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (prefilled syringe) (lot number: UJ283AA, Expiration Date: 29-May-2020)  via intramuscular route in the left deltoid inadvertently on 28-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  No other vaccine was given.   It was a case of actual medication error due to inappropriate age at vaccine administration and overdose and wrong vaccine administered.  At the time of reporting, the patient had no adverse event.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Rash macular
Clinical narrative: WITHIN 3 MINUTES PATIENT STATED HE COULD NOT BREATHE OR CATCH HIS BREATH. ALSO BROKE OUT IN A RED, FINE RASH ALL OVER HIS BODY. PATIENT WAS GIVEN 30MG OF PREDNISOLONE AND HIS SYMPTOMS SUBSIDED WITHIN 20 MINUTES. FOLLOWED UP WITH MOM TODAY, AND PATIENT NO LONGER HAS ANY SYMPTOMS.
Age: 71.0
Sex: F
Vaccine: TDAP, DTP
Symptoms: Pain in extremity
Clinical narrative: severe pain in right arm that has not yet resolved
Age: 71.0
Sex: F
Vaccine: TDAP, DTP
Symptoms: Abdominal discomfort, Acupuncture, Nausea, Pain, Pain in extremity
Clinical narrative: severe pain in right arm that has not yet resolved
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Sleep disorder
Clinical narrative: Patient describes pain in her arm starting the evening after her vaccine. Patient says pain is in upper arm/shoulder area and has been so painful she can not sleep.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Bilirubin conjugated, Blood smear test, Chromaturia, Decreased appetite, Dehydration
Clinical narrative: 7/22/2019 - DISCOLORED URINE, FATIGUE: 7/23/2019 DR VISIT DIAGNOSED WITH DEHYDRATION: 7/25/2019 EXTREME FATIGUE, SLURRED WORDS, NO APPETITE: 7/26/2019 WENT TO EMERGENCY ROOM - DIAGNOSED WITH WARM AUTOIMMUNE HEMOLYTIC ANEMIA - TWO BLOOD TRANSFUSIONS AND 80MG PREDNISONE INITIALLY, WEEKLY INFUSION OF RITUXIN FOR 4 WEEKS AND CONTINUED PREDNISONE - CURRENTLY 15 MG/DAILY
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Differential white blood cell count, Dysarthria, Fatigue, Full blood count, Haemoglobin decreased
Clinical narrative: 7/22/2019 - DISCOLORED URINE, FATIGUE: 7/23/2019 DR VISIT DIAGNOSED WITH DEHYDRATION: 7/25/2019 EXTREME FATIGUE, SLURRED WORDS, NO APPETITE: 7/26/2019 WENT TO EMERGENCY ROOM - DIAGNOSED WITH WARM AUTOIMMUNE HEMOLYTIC ANEMIA - TWO BLOOD TRANSFUSIONS AND 80MG PREDNISONE INITIALLY, WEEKLY INFUSION OF RITUXIN FOR 4 WEEKS AND CONTINUED PREDNISONE - CURRENTLY 15 MG/DAILY
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Lipase, Metabolic function test, Reticulocyte count, Transfusion, Warm type haemolytic anaemia
Clinical narrative: 7/22/2019 - DISCOLORED URINE, FATIGUE: 7/23/2019 DR VISIT DIAGNOSED WITH DEHYDRATION: 7/25/2019 EXTREME FATIGUE, SLURRED WORDS, NO APPETITE: 7/26/2019 WENT TO EMERGENCY ROOM - DIAGNOSED WITH WARM AUTOIMMUNE HEMOLYTIC ANEMIA - TWO BLOOD TRANSFUSIONS AND 80MG PREDNISONE INITIALLY, WEEKLY INFUSION OF RITUXIN FOR 4 WEEKS AND CONTINUED PREDNISONE - CURRENTLY 15 MG/DAILY
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fatigue
Clinical narrative: Pt reports 1 hour after receiving flu vaccine began to experience significant body fatigue and lightheadedness/dizziness. PT followed up about 4.5 hours after vaccine and was evaluated in office (normal exam, VS, BG). Reviewed red flags/precautions for immediate follow up in ER and was driven home by husband. No previous adverse reaction.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Feeling hot, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pt called this morning complianing of nausea, hot, stomach discomfort. She said she feels every sick and has aches at the injection site with redness and little swelling. Instructed her to take some Benadryl, use motrin and ice packs and call the doctor's office or pharmacy if the reaction gets worse.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea
Clinical narrative: Pt called this morning complianing of nausea, hot, stomach discomfort. She said she feels every sick and has aches at the injection site with redness and little swelling. Instructed her to take some Benadryl, use motrin and ice packs and call the doctor's office or pharmacy if the reaction gets worse.
Age: 17.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Fall, Feeling abnormal, Feeling hot, Hypoaesthesia, Limb discomfort
Clinical narrative: PC from pt. Pt reports she received HPV vaccine & Meningococcal vaccine yesterday  here at clinic. Pt thinks she may have had a reaction to one of the vaccines she  received. Reports she did not wait in clinic 20 minutes like the nurse had  advised. Reports when she arrived at her boyfriend's house about 20 minutes after  getting the injections, she "felt numb" and fell to the floor. Says she couldn't  feel her arms and legs. Boyfriend put pt in bed and she slept for 3 hours. Reports  she then drove herself home although her arms and legs "felt heavy." States she  went to sleep when she got home. Reports she was better when she woke up this  morning but still "doesn't feel like herself." States she has been "burning up"  all day. Pt has not checked temperature today.
Age: 48.0
Sex: M
Vaccine: UNK
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Was a TDaP vaccine but I don't know the brand or lot number, etc. Initial soreness, swelling and hardness to injection site.  Sore to raise arm. Improvement by Nov 2 and Nov 3. Morning on Nov 4 woke up with injection arm highly swollen and small red spot. Could barely lift arm above waist level without assistance from other arm.  By evening of Nov 4 went to Urgent Care facility (same facility as provided injection) and arm was much more red and swollen down to elbow. Pain
Age: 48.0
Sex: M
Vaccine: UNK
Symptoms: Pain
Clinical narrative: Was a TDaP vaccine but I don't know the brand or lot number, etc. Initial soreness, swelling and hardness to injection site.  Sore to raise arm. Improvement by Nov 2 and Nov 3. Morning on Nov 4 woke up with injection arm highly swollen and small red spot. Could barely lift arm above waist level without assistance from other arm.  By evening of Nov 4 went to Urgent Care facility (same facility as provided injection) and arm was much more red and swollen down to elbow. Pain
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Oculorespiratory syndrome
Clinical narrative: Oculorespiratory syndrome
Age: 65.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Herpes zoster
Clinical narrative: One week after vaccines developed shingles rash..diagnosed by Dr.. treatment ordered is Valacyclovir 1 Gm TID for 7 days
Age: 16.0
Sex: F
Vaccine: FLU4, HPV9, MNQ
Symptoms: Loss of consciousness, Pallor
Clinical narrative: first vaccine given was flu, then menactra in right arm, then HPV in left arm, approximately 3 seconds after last vaccine given  patient said she felt "something" and lost consciousness for 3-10 seconds. Patient was put in supine position on her right side on exam table. revived with calling her name and ammonia salts. patient was pale, no clamminess or other complaints. After event client reported to her mother that she passed out or nearly passed out after a blood draw in the past.
Age: 0.17
Sex: F
Vaccine: UNK
Symptoms: Seizure like phenomena
Clinical narrative: Seizure like activity
Age: 35.0
Sex: F
Vaccine: ANTH
Symptoms: Cellulitis, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Patient started the evening of vaccine with erythema surrounding site which spread for 3 days, measuring 10 cm x 6 cm when seen for visit 11/05/19, tender with central nodule - Treated for cellulitis with doxycycline 100 mg BID for 10 days, ice.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Abdominal pain, Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood alkaline phosphatase increased, Blood alkaline phosphatase normal
Clinical narrative: Three days after receiving the vaccine the patient started having nonspecific constitutional symptoms. A few days after that he developed additional symptoms of nausea, vomiting, abdominal pain, and dark urine. After several days of worsening symptoms he sought care and was found to have acute hepatitis
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Blood bilirubin increased, Chromaturia, Hepatitis acute, Laboratory test normal, Nausea
Clinical narrative: Three days after receiving the vaccine the patient started having nonspecific constitutional symptoms. A few days after that he developed additional symptoms of nausea, vomiting, abdominal pain, and dark urine. After several days of worsening symptoms he sought care and was found to have acute hepatitis
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Neutrophil count decreased, Platelet count decreased, Vomiting, White blood cell count decreased
Clinical narrative: Three days after receiving the vaccine the patient started having nonspecific constitutional symptoms. A few days after that he developed additional symptoms of nausea, vomiting, abdominal pain, and dark urine. After several days of worsening symptoms he sought care and was found to have acute hepatitis
Age: 8.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Vomiting
Clinical narrative: PT WAS ADMINISTERED INFLUENZA VACCINE, ABOUT 5 MINUTES LATER, PT SAID SHE WAS NAUSEATED AND VOMITED. PT SAID SHE FELT FINE AFTERWARDS. CALLED 911 JUST TO BE SAFE, PARAMEDICS ARRIVED IN 10 MINUTES CHECKED HER VITAL SIGNS AND SAID SHE WAS FINE AND GOOD TO GO HOME OR URGENT CARE. MOTHER CHOSE TO GO HOME. CALLED PATIENT'S MOM THE NEXT DAY AND WAS INFORMED THAT PATIENT WAS DOING FINE.
Age: 7.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Eye pain, Eye swelling, Vomiting
Clinical narrative: He received the shot on 11/5/2019 @1015-1020 and by 1030 he was throwing up and had horrible stomach pain. By 12:20 his right eye was swollen and hurt. I did not give hi. The ibuprofen the doctor office told me to give him when I first called at1104am. When I called back at 104pm I was told to give him Benadryl which I did not. Tonight at 630 it is still swollen but not as bad.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: As warned I experienced fever and chills and general malaise starting about 24 hrs after the shot, lasting about 72 hours with lessening severity. The first 48 hrs I felt too ill to participate in much and spent most of the time laying down.  The swelling in my arm is getting worse, 96 hours later the injection site and an oblong area about 4 inches wide and 2 inches tall surrounding it is hard and hot and itchy, with a less red area around it.
Age: 52.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injection site warmth, Malaise, Pyrexia
Clinical narrative: As warned I experienced fever and chills and general malaise starting about 24 hrs after the shot, lasting about 72 hours with lessening severity. The first 48 hrs I felt too ill to participate in much and spent most of the time laying down.  The swelling in my arm is getting worse, 96 hours later the injection site and an oblong area about 4 inches wide and 2 inches tall surrounding it is hard and hot and itchy, with a less red area around it.
Age: 30.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Muscle tightness, Myalgia
Clinical narrative: Patient stated he had pain in at the injection site beginning the day of immunization, sore muscle and muscle tightness. It was getting better a few days later then he re-aggrivated the arm. The patient reported the event 11/05/2019 while receiving medication prescribed to treat the adverse reaction.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Abdominal pain upper, Feeling hot, Hyperhidrosis, Nausea
Clinical narrative: Daughter started with severe stomach cramps..  said she wanted to throw up.  Was rolling around and crying in pain.  She felt hot but I didn?t have thermometer and she was sweating.  Her upset stomach lasted all until the next morning.  Called and left voicemail to doctors office we will not be taking shot 2 of Meningitis B
Age: 48.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Heart rate increased, Insomnia, Pyrexia
Clinical narrative: Patient had fever within 7 hours of injections, elevated heart rate averaging 130bpm for 5 days as monitored by his smart watch, and 36 hours of insomnia following the injections
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Pt states she received both her HD flu and pneumococcal 23 vaccine in same site. Next day swelling, redness, and pain below injection site.  Symptoms worsened the next day affecting about a 7x11 cm area, but had slight improvement by 3rd day after taking Motrin 400 mg x 1 (7x10 cm) and less tenderness, redness.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Periarthritis, Product administered at inappropriate site
Clinical narrative: Patient states that she was told by physician that pneumovax was given too high up and has affected shoulder. States joine is frozen.