chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of general body pain in a 59-year-old female patient who received Shingrix for prophylaxis. On 24th April 2018, the patient received the 1st dose of Shingrix. In April 2018, less than a day after receiving Shingrix, the patient experienced bedridden, mobility decreased, muscle pain, joint pain and ligament pain. On 24th April 2018, the patient experienced general body pain. On an unknown date, the outcome of the general body pain, bedridden and mobility decreased were recovered/resolved and the outcome of the muscle pain, joint pain and ligament pain were unknown. It was unknown if the reporter considered the general body pain, bedridden, mobility decreased, muscle pain, joint pain and ligament pain to be related to Shingrix. Additional details were provided as follows: The caller reported that less than a day after receiving Shingrix, the patient experienced whole body hurt, except her face. By midnight of the day of the vaccination, the patient could not lift her arm. The patient's every muscle, joint and ligament in her body ached and she could not get out of bed for 3 days. By the 4th day, the patient felt better and was up and about.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site warmth, Skin warm
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of erythema of extremities in a 66-year-old female patient who received SHINGRIX (batch number 957J3, expiry date unknown) for prophylaxis. On 13th August 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 13th August 2018, less than a day after receiving SHINGRIX, the patient experienced erythema of extremities and skin warm. On an unknown date, the outcome of the erythema of extremities and skin warm were recovered/resolved. It was unknown if the reporter considered the erythema of extremities and skin warm to be related to SHINGRIX. Additional details were provided as follows: The caller was a pharmacist calling on behalf of a patient. The patient experienced redness at the injection site following the injection and also the injection site was warm to the touch, after approximately 1 day, the redness and warm to touch moved further down her arm below the injection site. This is 1 of the 3 linked cases reported by the same reporter.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shingles in a 73-year-old female patient who received SHINGRIX for prophylaxis. On 14th September 2018, the patient received the 1st dose of SHINGRIX .5 ml. On 26th September 2018, 12 days after receiving SHINGRIX, the patient experienced shingles. The patient was treated with VALTREX. On an unknown date, the outcome of the shingles was recovering/resolving. It was unknown if the reporter considered the shingles to be related to SHINGRIX. Additional details were reported as follows: After vaccination, the patient experienced a mild case of shingles on her right buttock. The patient reported that, the shingles had improved. The contact details of the physician was provided.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Optic neuritis
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of optic neuritis in a adult female patient who received SHINGRIX (batch number XC534, expiry date 4th July 2020) for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced optic neuritis (serious criteria GSK medically significant). On an unknown date, the outcome of the optic neuritis was recovered/resolved. It was unknown if the reporter considered the optic neuritis to be related to SHINGRIX. Additional details were provided as follows: The age at the vaccination was not reported. In 2018, the patient developed optic neuritis. The healthcare professional could not provide any further information about the patient. The optic neuritis was confirmed by the Clinic. Follow up could be done with health care professional for further details.
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Pruritus, Urticaria
Clinical narrative: This case was reported by a nurse and described the occurrence of allergic reaction in a female patient who received FLULAVAL QUADRIVALENT 2018-2019 season (batch number TA422, expiry date 30th June 2019) for prophylaxis. Previously administered products included Influenza shot (received every year for the past 14 years). On 5th October 2018, the patient received FLULAVAL QUADRIVALENT  2018-2019 season. On 5th October 2018, less than a day after receiving FLULAVAL QUADRIVALENT 2018-2019 season, the patient experienced allergic reaction and urticaria. The patient was treated with benadryl (nos) (Benadryl). On an unknown date, the outcome of the allergic reaction and urticaria were unknown. It was unknown if the reporter considered the allergic reaction and urticaria to be related to FLULAVAL QUADRIVALENT 2018-2019 season. Additional details were provided as follows: This case was reported by a nurse for herself. The age at vaccination was not reported. The patient experienced allergic reaction, described as welts with severe itching on thoracic area, trapezoid and popliteal area. The patient had taken Benadryl 50 mg on 5th October 2018 and another Benadryl 25 mg on 6th October 2018. The nurse tried to figure out if there was a molecular component that was different from the previous shots she had received compared to this year so she could avoid further allergic reactions in the future. The nurse wondered if there were a few people this year, who have had an allergic reaction to this year's vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a adult female patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe flu like symptoms for 2 days. The reporter agreed to be contacted by GlaxoSmithKline. This case has been linked with case US2018GSK188965, reported by the same reporter.
Sex: M
Vaccine: VARZOS
Symptoms: Influenza like illness
Clinical narrative: This case was reported by a other health professional via sales rep and described the occurrence of influenza-like symptoms in a elderly male patient who received SHINGRIX for prophylaxis. On an unknown date, the patient received the 1st dose of SHINGRIX. On an unknown date, less than a year after receiving SHINGRIX, the patient experienced influenza-like symptoms. On an unknown date, the outcome of the influenza-like symptoms was unknown. It was unknown if the reporter considered the influenza-like symptoms to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. The patient experienced severe flu like symptoms for 2 days. The reporter agreed to be contacted by GlaxoSmithKline. This case has been linked with case US2018GSK188963, reported by the same reporter.
Sex: F
Vaccine: MMRV, TDAP
Symptoms: Gait disturbance, Hypotonia, Musculoskeletal stiffness
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of stiff neck in a female patient who received BOOSTRIX (batch number 33T42, expiry date unknown) for prophylaxis. Co-suspect products included PROQUAD for prophylaxis. On 28th September 2018, the patient received BOOSTRIX and PROQUAD. In September 2018, less than a week after receiving BOOSTRIX, the patient experienced stiff neck and limping. On an unknown date, the outcome of the stiff neck and limping were recovering/resolving. It was unknown if the reporter considered the stiff neck and limping to be related to BOOSTRIX. Additional details were provided as follows: The age at vaccination was not reported. On 30th September 2018, the patient came to clinic. Again, on 2nd October 2018 and 3rd October 2018, the patient visited the clinic. On 3rd October 2018, the symptoms of neck stiffness and limp extremities started to resolve spontaneously. It was unknown if the reporter considered the stiff neck and limping to be related to PROQUAD as well.
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a adult female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2018-2019 season) for prophylaxis. On an unknown date, the patient received Influenza vaccine Quadrivalent 2018-2019 season. On an unknown date, less than a week after receiving Influenza vaccine Quadrivalent 2018-2019 season, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was unknown. It was unknown if the reporter considered the pain in arm to be related to Influenza vaccine Quadrivalent 2018-2019 season. Additional details were reported as follows: This case was reported by the patient's husband. The age at vaccination was not reported. Last week from the reporting date, the patient received a dose of whooping cough/tetanus vaccine in one arm and flu vaccine in the other arm as per primary care physician (PCP) recommendation. The patient had no big deal, his both arms were a little bit sore. It was unknown if the reporter considered the arms a little sore to be related to whooping cough/tetanus vaccine. This case has been linked to the US2018GSK179833, reported by the same reporter.
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Influenza like illness, Malaise, Swelling
Clinical narrative: This case was reported by a consumer via sales rep and described the occurrence of cellulitis in a female patient who received SHINGRIX for prophylaxis. In October 2018, the patient received the 1st dose of SHINGRIX. In October 2018, less than a week after receiving SHINGRIX, the patient experienced cellulitis (serious criteria GSK medically significant), localized erythema, local swelling, feeling unwell and influenza like illness. The patient was treated with antibiotics nos (Antibiotics (Brand Names Not Known)). On an unknown date, the outcome of the cellulitis, localized erythema, local swelling, feeling unwell and influenza like illness were recovering/resolving. It was unknown if the reporter considered the cellulitis, localized erythema, local swelling, feeling unwell and influenza like illness to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not provided. The patient's age was greater than 50 years at the time of reporting. The patient received SHINGRIX within last week of the date of reporting. The patient experienced local redness and swelling and feeling unwell (flu-like per reporter). The patient received antibiotic medication (unknown) and started feeling better within a couple days. The reporter described it as a possible cellulitis infection. The patient felt better and she was recovering per the reporter.
Sex: F
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of guillain barre syndrome in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis. On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome was unknown. It was unknown if the reporter considered the guillain barre syndrome to be related to Flu vaccine. Additional information was reported as follows: The age at vaccination was not reported. The batch number for flu vaccine was not reported. The patient was vaccinated with a unspecified flu vaccine, a few years ago. The healthcare professional was not sure of which flu vaccine it was or when it happened. The healthcare professional did not have any further information.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Hypoaesthesia, Injection site pain, Musculoskeletal pain, Neck pain, Pain in jaw
Clinical narrative: Numbness in Left thumb extreme pain staring at shot site them moving up to shoulder/neck, shoulder blade, back of jaw.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Injection site oedema, Injection site pain, Pain in extremity
Clinical narrative: Client received her flu shot in (L) delt. at a F/U outreach held by agency and not by this nurse. Client states pain started at injection site at time of administration and has radiated to elbow. There is a 6cm w x 3cm edematous tender area at (L) antecube Pain 8/10 "toothache pain" to (L) arm. (R) elbow circumference =5cm, (L) elbow =6cm. Ibuprofen 200mg 2 tabs, cool compress, ace wrap at 50% compression applied to site.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Nausea, Swelling face, Wheezing
Clinical narrative: Wheezing began a few hours after receiving the administration. Next morning had swelling of face, started feeling nauseous and then passed out.
Age: 1.67
Sex: F
Vaccine: DTAPIPVHIB, MMR, PNC13, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Weight bearing difficulty
Clinical narrative: Guardian noticed first signs of reaction 8 days after vaccine administration around 8 PM. Symptoms were swelling in left upper thigh, skin was pink but no change in temperature to touch. Child would not bear weight on left leg. Next day (within 24 hours) symptoms were gone.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Injection site pain, Pain
Clinical narrative: Patient states she had left shoulder/arm pain after administration of her flu vaccine on 09/24/18. She states that she felt pressure in her left shoulder joint with the administration of the vaccine. She rates the left shoulder discomfort 6/10 aching, stabbing, burning with certain movements. She denied any numbness, tingling or weakness in the LUE. No erythema, edema, streaking in the LUE. No cervical spine tenderness. Full ROM of the left shoulder joint with minimal discomfort on initial evaluation 10-11-18 at office. No neurovascular deficits.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Herpes zoster
Clinical narrative: Shingles outbreak following flu vaccination.
Age: 24.0
Sex: F
Vaccine: FLUX, HEP
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: I want to state that I am unsure of what manufacturer these vaccines are. They don't give that info to patients. I just know I received hep B and influenza. I took BENADRYL over the counter and watched for hives to spread more on my face. After an hour went by it didn't seem that they spread any further and I went to bed. I have hives on left side of face and they burn and itch and my face felt some what right.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: Patient had a 5 cm x 6 cm reddened area to her right thigh. The redness had faded now. Patient's mother had a picture on her cell phone that showed how red it was over the weekend.
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Paraesthesia
Clinical narrative: Patient states she started experiencing tingling in the arm after vaccination that has not alleviated since vaccination. Called primary care physician to report side effect 10/24/18 at 11:10 am.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity, Urticaria
Clinical narrative: Employee states on the same day as the injection left arm began to ache. By the evening, broke out in hives and arm pain. Continue to C/O pain and was sent to Occupational Health Clinic on 10/22/18.
Age: 58.0
Sex: M
Vaccine: UNK
Symptoms: Chills, Insomnia, Neuralgia, Pyrexia, Tremor
Clinical narrative: Massive chills, shaking and shivering, fever, neuralgia, sleeplessness.
Age: 48.0
Sex: F
Vaccine: FLUC4
Symptoms: Dizziness, Nausea, Vision blurred
Clinical narrative: Staff called approx. 0930am after injection and reported dizziness, not able to focus, and nausea.  Staff called PCP and said to stay still for a couple of hours and not better go to ER.
Age: 42.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Swollen red arm around injection site.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Lacrimation increased, Mobility decreased, Myalgia, Sleep disorder
Clinical narrative: The injection site burned at the time of the injection to the point it brought tears to my eyes. The burning con't. for 2 hours. Then the muscle was very sore to the point I couldn't move my arm. The muscle soreness con't and wakes me up at night.
Age: 26.0
Sex: F
Vaccine: UNK
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Arm pain in area where shot was placed. Swelling and redness of the area. Hot and painful to the touch. I have been instructed to take BENADRYL and ibuprofen for the symptoms.
Age: 43.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pain, Paraesthesia, Rash macular
Clinical narrative: Staff member complained of feeling like she was punched in the right cheek along with throbbing and tingling in that area. Face and chest was red and blotchy. Patient was given BENADRYL 50mg oral and observed. Symptoms did not progress and resolved over 24 hours.
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pain in extremity
Clinical narrative: Pt states he still has arm pain and pain with lifting arm 3.5 weeks after receiving vaccination. Pt following up with MD.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Scar
Clinical narrative: Ten days after the shot, I had a breakout of shingles on the inside of each wrist, approximately 2 inches up each arm from the wrist. It did not hurt, nor did it itch. It lasted about three weeks. I still have faint scars. I am wondering if I should have the second dose.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain
Clinical narrative: Unusual pain in the injection site. States never experienced before with an influenza injection. Iced the area and took anti-inflammatories.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Injection site pain
Clinical narrative: 100 degree fever for 2 days; chills/shivering; body aches; fatigue; felt fluish; whole arm hurt; red swollen very tender and sore spot the width of a softball at the site of the injection. 3rd day symptoms much better but still noticeable but could resume all activities. I have never had a reaction to an immunization in all the years of getting vaccines and flu shots or at least not to the degree that I ever noticed. This wiped me out for 2 days. I had previously had the older version of this immunization and no reaction.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Pain, Pain in extremity, Pyrexia
Clinical narrative: 100 degree fever for 2 days; chills/shivering; body aches; fatigue; felt fluish; whole arm hurt; red swollen very tender and sore spot the width of a softball at the site of the injection. 3rd day symptoms much better but still noticeable but could resume all activities. I have never had a reaction to an immunization in all the years of getting vaccines and flu shots or at least not to the degree that I ever noticed. This wiped me out for 2 days. I had previously had the older version of this immunization and no reaction.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Fatigue, Lethargy, Mobility decreased, Swelling
Clinical narrative: Left armpit swollen to convex, approx. 6-7 inches long, protrudes approx. 2 inches out. Tired, lethargic, body weighty/hard to move.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Anxiety, Cold sweat, Condition aggravated, Dizziness, Loss of consciousness
Clinical narrative: Patient had an anxiety attack after receiving flu vaccine. Patient was dizzy and skin was pale and clammy, lasted approx 15 minutes. Mom stated "on occasion he passes out, he passed out at doctors office recently after receiving a shot". He vomited undigested food and felt better. Had him lay down with ice to back of neck and head and soon he felt better. HR=64. Patient improved and left with mom.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Pallor, Vomiting
Clinical narrative: Patient had an anxiety attack after receiving flu vaccine. Patient was dizzy and skin was pale and clammy, lasted approx 15 minutes. Mom stated "on occasion he passes out, he passed out at doctors office recently after receiving a shot". He vomited undigested food and felt better. Had him lay down with ice to back of neck and head and soon he felt better. HR=64. Patient improved and left with mom.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Inflammation
Clinical narrative: Inflammed area on inside aspect of left arm going down towards the elbow.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Cough, Diarrhoea, Dyspnoea, Fatigue
Clinical narrative: A cough. A sore throat. Breathing problems. Runny or stuffy nose. Body aches. A headache. Chills and shakes. Fatigue. Gastrointestinal problems (vomiting and diarrhea) All started two hours after receiving the vaccine. Drove home at  03:00 PM took ibuprofen and went to bed. After worming up symptoms seemed to subside. Had trouble sleeping that night and was forced to take a day off from work because of feeling exhausted.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Gastrointestinal disorder, Headache, Insomnia, Nasal congestion, Oropharyngeal pain
Clinical narrative: A cough. A sore throat. Breathing problems. Runny or stuffy nose. Body aches. A headache. Chills and shakes. Fatigue. Gastrointestinal problems (vomiting and diarrhea) All started two hours after receiving the vaccine. Drove home at  03:00 PM took ibuprofen and went to bed. After worming up symptoms seemed to subside. Had trouble sleeping that night and was forced to take a day off from work because of feeling exhausted.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Pain, Rhinorrhoea, Tremor, Vomiting
Clinical narrative: A cough. A sore throat. Breathing problems. Runny or stuffy nose. Body aches. A headache. Chills and shakes. Fatigue. Gastrointestinal problems (vomiting and diarrhea) All started two hours after receiving the vaccine. Drove home at  03:00 PM took ibuprofen and went to bed. After worming up symptoms seemed to subside. Had trouble sleeping that night and was forced to take a day off from work because of feeling exhausted.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Patient fainted after receiving flu vaccine. Placed on floor with legs elevated, ice pack applied to head and neck. 4:35 PM BP= 112/68, P=70, R=20. PEERLA, Pulse strong and regular. 4:45 BP=110/62, P=74, R=20. 5:00 BP=110/64, P=72, R=20. After resting patient felt better after approx 30 mins.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Hyperhidrosis, Muscular weakness, Musculoskeletal pain, Neck pain, Pruritus
Clinical narrative: Receive the vaccine, got a rash in my chest and on my left arm. Looking like mosquito bites. Continue to itch. Sweating all over my body. Weak in the legs when standing. Shoulder pain radiating to neck. Running nose.
Age: 40.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Rhinorrhoea
Clinical narrative: Receive the vaccine, got a rash in my chest and on my left arm. Looking like mosquito bites. Continue to itch. Sweating all over my body. Weak in the legs when standing. Shoulder pain radiating to neck. Running nose.
Age: 60.0
Sex: F
Vaccine: HIBV, MENB, MNQ, PPV
Symptoms: Incorrect product formulation administered, No adverse event, Product preparation error
Clinical narrative: MENACTRA was given as the diluent for ACTHIB instead of normal 0.4% sodium chloride diluent. No patient related adverse events were documented from this visit.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling, Rash, Rash erythematous, Tenderness
Clinical narrative: Red rash that spread from upper arm to forearm, swelling, pain on touching.
Age: 0.42
Sex: F
Vaccine: PNC13
Symptoms: Insomnia
Clinical narrative: The patient only slept a combined total of 12 hours in the 48 hours following the vaccination. The patient typically slept 28 hours in a 48 hour period.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Dizziness, Dyspnoea, Erythema, Pyrexia
Clinical narrative: Throat felt as though it was closing up, face swollen, hard to breath, heaviness in chest, chest red with hives, feverish, and lightheaded.
Age: 26.0
Sex: F
Vaccine: FLU4
Symptoms: Swelling face, Throat tightness, Urine analysis normal, Urticaria, White blood cell count increased
Clinical narrative: Throat felt as though it was closing up, face swollen, hard to breath, heaviness in chest, chest red with hives, feverish, and lightheaded.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Chills, Headache, Injection site pain, Injection site reaction, Nausea
Clinical narrative: Beginning the evening of the shot, patient had pain at the injection site followed by 5 days of headache, body ache, chills and nausea. On the sixth day a red blotchy rash was noted above and below the injection site. Patient was seen by her family practice doctor. He felt the symptoms were consistent with an adverse reaction and recommended that she does not get the second dose in the series.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Pain, Rash erythematous, Rash macular, Vaccination complication
Clinical narrative: Beginning the evening of the shot, patient had pain at the injection site followed by 5 days of headache, body ache, chills and nausea. On the sixth day a red blotchy rash was noted above and below the injection site. Patient was seen by her family practice doctor. He felt the symptoms were consistent with an adverse reaction and recommended that she does not get the second dose in the series.
Age: 7.0
Sex: M
Vaccine: DTAP, HEP, HEPA, IPV, MMRV
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Patient should have received Tdap instead patient received DAPTACEL dtap. No currently reported adverse events experienced by the patient.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased
Clinical narrative: PT CAME IN TODAY AND SAID THEY CANNOT LIFT THERE LEFT ARM AFTER THE IMMUNIZATION OF PNEUMOVAX. PT HAS HAD PLENTY OF VACCINES BEFORE SUCH AS PREVNAR, FLU AND SHINGLES AND HAS NEVER REACTED LIKE THIS BEFORE. HE HAS LIMITED MOVEMENT OF HIS LEFT ARM.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Nausea, Peripheral swelling, Pyrexia
Clinical narrative: High fever, arm swelling, nausea.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Fatigue, Headache, Injection site erythema
Clinical narrative: Had pain, redness and swelling at injection site along with muscle pain, tiredness, headache, shivering, fever (103F) and upset stomach. It was definitely from the injection I received. I did not follow up with my doctor because I knew these were the common side effects after receiving the SHINGRIX vaccine. Never have I experienced anything like this from any vaccines I have had previously.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling, Myalgia, Pyrexia
Clinical narrative: Had pain, redness and swelling at injection site along with muscle pain, tiredness, headache, shivering, fever (103F) and upset stomach. It was definitely from the injection I received. I did not follow up with my doctor because I knew these were the common side effects after receiving the SHINGRIX vaccine. Never have I experienced anything like this from any vaccines I have had previously.
Age: 87.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Urticaria
Clinical narrative: Hives all over left arm. Slightly raised and very itchy.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Asthma, Pain in extremity
Clinical narrative: Asthma exacerbation, upper extremity pain. Tx: Albuterol dosed 2 puff every 4 hrs as needed.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Pain in extremity, Pyrexia, Rash, Rash macular
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A female patient of an unspecified age received PREVNAR 13; (lot number: W33491 and expiration date: Jun2020), via an unspecified route of administration on 09Oct2018 at a single dose in the left arm for immunisation. The patient's medical history was not reported. Concomitant medication included influenza vaccine on 09Oct2018 at an unspecified dose in the right arm for flu shot. It was reported that the patient got PREVNAR 13 in her left arm and the flu shot in her right arm. The reporter would like to get information on common side effects for PREVNAR 13 vaccine. She stated that she gave it to the patient and would like to see if it was a reported event. She gave the patient the PREVNAR vaccine in her left arm and the flu shot in her right arm. She gave the PREVNAR vaccine in the patient's left arm and the patient said that she had severe pain in the left arm. The reporter told the patient that it was normal as most people complained of that. She stated however that the patient also had a little fever for 2 days and blotchy rash on her left arm only. The reporter wanted to know if these are common side effects. Outcome of event fever was recovered while unknown for other events.
Sex: U
Vaccine: PNC13
Symptoms: Joint range of motion decreased, Pain
Clinical narrative: This is a spontaneous report from a contactable pharmacist. A 64-year-old patient of unspecified gender received PREVNAR 13 on an unspecified date in Oct2018, at single dose, for immunization. Medical history and concomitant medications were not reported. The patient was very sore and had trouble with range of motion since an unspecified date in Oct2018. Events outcome was unknown. Information on the batch number has been requested.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Injection site reaction had redness, warmth, and swelling at right deltoid. Received flu vaccine on 10/18/18 seen in clinic on 10/19/18 and 10/22/18. Advised mother to treat with 6.84mL of acetaminophen also treated with 6.84mL of acetaminophen in clinic on 10/19/18. Informed to rotate acetaminophen and ibuprofen, use cool compress and continue to monitor follow up on 10/22/18. Seen on 10/22/18 for follow up. Swelling reduced significantly. Mild redness over right upper arm. Advised to continue to monitor and return to clinic if worsening. Reaction site has improved, but still has some redness. 10/23/18 Contacted health department parent was given influenza vaccine insert and advised to bring to PCP follow up on 10/22/18. Facility has called health dept spoke with lady, unable to give information on vaccine x2, due to nurse who administered being out until 10/24/18. She reported "we send those papers to the health dept to be entered in." Spoke with Administration for health dept states they will start paperwork for reaction, and will have nurse call me. Does not have access to lot number given. Nurse from Health dept, called to report he was given FLUARIX QUADRIVALENT given IM, RD 0.5mL does not have lot number, or access to it. States she "will have nurse call me tomorrow." 10/24/18 Nurse who administered flu vaccine states "I will call back with Lot number". Returned call Lot number is GSK94557.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Urticaria
Clinical narrative: Welt on neck, and stiffness. I received the flu vaccine on Monday (10-1-18). Received steroid shot for bites last week.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Had the flu vaccine at 2/2:30 PM, and I developed hives on my neck, chest and arms at around 3 PM.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pruritus
Clinical narrative: Began itching then turned red with swelling under the injection site and sore.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Patient received the flu shot and within 4 hrs she got a hive on the back of her neck. The next day she had several more raised red welts. By 1700 10/10/2018 she noticed she had multiple raised red welts in between her thighs and on her arm. These welts were also itchy. She contacted her PMD who recommended hydrocortisone cream and BENADRYL. She took 50 mg of BENADRYL PO and applied the hydrocortisone cream to the affected areas per MD order. The next day she had even more welts and went to her PMD office. She was given 20 mg PO prednisone and 80 mg methylprednisolone IM. Even with all these interventions the welt persisted. She is free of hives on approx. 90% of her body today.
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: Biopsy skin abnormal, Dermatitis allergic, Dry skin, Erythema, Pruritus
Clinical narrative: Diffuse very itchy maculopapular eruption starting on hips and spreading over entire torso, arms, legs. Raised rough erythematous. No hives no vesicles no bullae. Requiring High dose steroid and hi dose H1 and H2 antihistamines for weeks.
Age: 46.0
Sex: M
Vaccine: FLUC4
Symptoms: Rash, Rash maculo-papular
Clinical narrative: Diffuse very itchy maculopapular eruption starting on hips and spreading over entire torso, arms, legs. Raised rough erythematous. No hives no vesicles no bullae. Requiring High dose steroid and hi dose H1 and H2 antihistamines for weeks.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Dizziness, Pallor
Clinical narrative: After receiving vaccines, patient turned pale and felt lightheaded. Returned to baseline after drinking water and lying down for a few minutes.
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia
Clinical narrative: Patient had trouble swallowing within 2-3min. of getting shot. Pt was told about protocol of giving EPIPEN and calling 911. She didn't want it, called daughter and then changed mind and said she wanted EPIPEN. RPh administered EPIPEN and called 911. Ambulance arrived and took her to hospital.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Erythema, Feeling abnormal, Headache, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: Patient did not feel good the evening of the vaccination and by that night had a fever of 102. His arm was also extremely painful. He continued to have a fever for the next 2 days and his arm became very red and swollen. On the 3rd day his fever became low grade and he returned to school. On the 7th day after the vaccination his fever returned and he developed a headache and a stiff neck. We observed him overnight and placed a call to the Doctor's aftercare service, but he was significantly better by the following day.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Peripheral swelling, Pyrexia
Clinical narrative: Patient did not feel good the evening of the vaccination and by that night had a fever of 102. His arm was also extremely painful. He continued to have a fever for the next 2 days and his arm became very red and swollen. On the 3rd day his fever became low grade and he returned to school. On the 7th day after the vaccination his fever returned and he developed a headache and a stiff neck. We observed him overnight and placed a call to the Doctor's aftercare service, but he was significantly better by the following day.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Infection
Clinical narrative: Pt called from a walk in clinic and said he and his wife both were being treated with antibiotics for an infection they said occured after their shots. Forwarded this information to our corp people. That was Sunday the 21.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Dyspnoea, Eye discharge, Eye swelling, Feeling cold
Clinical narrative: 3 hours later began dry cough, shortness of breath. 1 hour after that my face was swollen, mostly lips and eyes, eyes red, with yellow discharge forming in eyes. Began feeling extremely cold and shaking, even though wrapped in blankets. Body aches and skin irritated to fabrics. Took chlortrimiton and water and went to bed. Woke up with face and eyes still puffy but no other symptoms, went away by lunchtime the next day.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Ocular hyperaemia, Pain, Skin irritation, Swelling face
Clinical narrative: 3 hours later began dry cough, shortness of breath. 1 hour after that my face was swollen, mostly lips and eyes, eyes red, with yellow discharge forming in eyes. Began feeling extremely cold and shaking, even though wrapped in blankets. Body aches and skin irritated to fabrics. Took chlortrimiton and water and went to bed. Woke up with face and eyes still puffy but no other symptoms, went away by lunchtime the next day.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Tremor
Clinical narrative: 3 hours later began dry cough, shortness of breath. 1 hour after that my face was swollen, mostly lips and eyes, eyes red, with yellow discharge forming in eyes. Began feeling extremely cold and shaking, even though wrapped in blankets. Body aches and skin irritated to fabrics. Took chlortrimiton and water and went to bed. Woke up with face and eyes still puffy but no other symptoms, went away by lunchtime the next day.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Infection
Clinical narrative: Both him and wife reported infections after the shots. Went to a walk in clinic two days later. Reported this to coroporate.
Age: 1.5
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Extreme swelling of right thigh, a bit of swelling on left thigh. Bright red on the whole swelling for two days on both thighs, right thigh currently still swollen. Warm Compress given.
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Pain in extremity, Pyrexia
Clinical narrative: Mother reported to school nurse morning of 10/17/18 that patient had a fever of 104 deg F overnight with right arm pain. Fever resolved by morning, denied redness at injection site.
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Body temperature increased, Injection site pain
Clinical narrative: Mother reported daughter had a temp of 103 deg F Wednesday evening after getting the flu shot. Mom said injection site was sore but not red, swollen or hot. Mom mentioned that this has happened more than once when getting the shot.
Age: 77.0
Sex: M
Vaccine: FLUX, IPV
Symptoms: Periarthritis, Shoulder injury related to vaccine administration
Clinical narrative: SIRVA after influenza vaccine. Pt with adhesive capsulitis. Outcome TBD - pt sent to physical therapy.
Age: 53.0
Sex: F
Vaccine: MMR, YF
Symptoms: Back pain, Discomfort, Dyspnoea, Laboratory test, Pain
Clinical narrative: Pain in lower back, Severe discomfort, achy. Heavy breathing to control pain. Fever don't recall. Contact Dr. 's PAs. They did a few tests on me. Symptoms subsided shortly after leaving Drs.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain
Clinical narrative: Complaint of pain, soreness, and nausea.
Sex: F
Vaccine: PNC13
Symptoms: Neoplasm malignant
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. This Pharmacist reported similar events for 2 patients (husband and wife). This is 2nd of 2 reports. A 74-year-old female patient received the 1st dose of PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history included immunocompromised. The concomitant medications were not reported. The patient experienced cancer on an unspecified date with outcome of unknown. The reporter wanted to know the patients should receive a second dose of PREVNAR 13, since  immunocompromised. Information on the batch number has been requested.; Sender's Comments: Cancer is unrelated to the vaccination with PREVNAR 13 representing an intercurrent malignancy. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate..,Linked Report(s) : US-PFIZER INC-2018421231 same reporter/product/event, different patient
Sex: F
Vaccine: PNC13
Symptoms: Injection site rash, Injection site swelling
Clinical narrative: This is a spontaneous report obtained from a contactable consumer (patient). A 66-year-old female patient received PREVNAR 13 on an unspecified date, at single dose, for immunization. Relevant medical history and concomitant medications were unknown. On an unspecified date, the patient experienced swelling and rash at the injection site. The rash seemed to be spreading and at time of this report it was down to her elbow and going around to the back of his arm; rash was reported as worsened. The patient was treated with BENADRYL and cold packs. The patient did not recover from the events at time of this report. The information on the lot number has been requested.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Expired product administered
Clinical narrative: Initial information received on 03-Oct-2018 regarding an unsolicited valid non-serious case received from a pharmacist. This case involves a 66 years old female patient who was given an expired FLUZONE HIGH DOSE vaccine, while she received vaccine FLUZONE HIGH DOSE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 03-Oct-2018, the patient received a 0.5 ml dose of suspect Influenza USP Trival A-B High Dose Subvirion Vaccine lot UI884AA, expiry date- 24-May-2018 via intramuscular route in the right deltoid. It was a case of actual medication error due to expired vaccine used. The patient outcome is reported as Not Applicable for was given an expired FLUZONE HIGH DOSE vaccine. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Sex: U
Vaccine: FLU3
Symptoms: Syringe issue
Clinical narrative: Initial information received on 27-Sep-2018 regarding an unsolicited valid non-serious case received from a consumer. This case involves a patient with unknown demographics received a 0.5 mL dose of suspect INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE lot number: UJ029AB, expiry date: 02-May-2019, via unknown route in unknown administration site. The patient's past medical history, medical treatments, vaccinations and family history were not provided. It was case of actual medication error due to underdose. It was also a case of syringe leak. The syringe was in the sharp container and not available for return. It was unknown whether the patient had any adverse event. Complaint reference number: CO2018-00303. This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error. List of documents held by sender: none.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling, Vaccination site inflammation
Clinical narrative: Initial information received on 12-Oct-2018 and additional information received on 15-Oct-2018 regarding an unsolicited valid non-serious case received from a Pharmacist. This case is linked to case 2018SA286240, 2018SA286241, 2018SA286245, 2018SA286243, 2018SA286244 This case is for patient number: 01 This case involves a female patient (age unknown) who experienced vaccination site inflammation, while she received vaccine FLUZONE. The patient's past medical history was not provided. No concomitant medications were taken. On 09-Oct-2018, the patient received a single 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UI982AA. On an unknown date, 48 hours post vaccination, the patient developed significant local redness and swelling that warm to the touch and the location of reaction was right below the injection. It was reported that 7 of the 10 individuals who received the vaccine had significant local reactions of redness, swelling, warm to touch, As of today 3 days post vaccine all are showing signs of improvement. two days after injection seemed to be the most significant time frame for peak reaction. (Other relevant tests included no lab data.) Final diagnosis was vaccination site inflammation. It was not reported if the patient received a corrective treatment. The patient outcome is reported as Unknown for vaccination site inflammation. Follow-up information was received from a Pharmacist on 15-Oct-2018. No new information was reported.
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Initial information received on 12-Oct-2018 regarding an unsolicited valid non-serious case received from pharmacist. This case is linked to case 2018SA286240, 2018SA286241, 2018SA286243, 2018SA286245, 2018SA286233, 2018SA286242, same reporter. This case involves Adult female patient who experienced local redness and swelling that warm to the touch, while she received vaccine FLUZONE. The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. On 09-Oct-2018, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED lot UI982AA, expiry date not provided via unknown route at unknown administration site. On unknown date, the patient developed a non-serious local redness and swelling that warm to the touch 48 hours following the administration of INFLUENZA QUADRIVAL A-B MULTIDOSE VACCINE PRESERVED. (Other relevant tests included no lab data.) Final diagnosis was local redness and swelling that warm to the touch. It was not reported if the patient received a corrective treatment. The patient outcome is reported as recovering for local redness and swelling that warm to the touch. Follow up information was received on 12-Oct-2018 from pharmacist. Outcome was updated. List of documents held by sender- none.