chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effects reported; Patient received an improperly stored dose ofROTATEQ; This spontaneous report was received from the vaccine coordinator and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant therapies were not reported.  On 03-OCT-2019, the patient was vaccinated with improperly stored dose of rotavirus vaccine, live, oral, pentavalent(ROTATEQ) lot # R026391, expiration date 09-JUL-2020, orally, for prophylaxis.      Temperature: (32.9F) Time frame: 3 hours 40 minutes Previous temperature excursion? NO Was call because of a "data logger"? YES  No adverse effects reported.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: No adverse effects; a patient inadvertently received a 4th dose of GARDASIL 9 on 31-OCT-2019; This spontaneous report was received from a nurse regarding a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medications were not reported. On 31-OCT-2019, the patient was inadvertently vaccinated with 4th dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) lot number: R028386, expiration date: 27-APR-2021, at a dose of 0.5 milliliter (mL) (strength, route of administration and anatomical location was not reported) for prophylaxis (extra dose administered). No adverse effects were reported. No product quality complaints were involved.
Sex: F
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: fainted shortly after receiving the dose.; Information has been received from a report on social media via the company representative, referring a female patient of unknown age. The patient's medical history, concurrent condition and concomitant medication were unknown.  On an unknown date, the patient was vaccinated with a dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (dose, frequency, route, lot# and expiration date were unknown)for prophylaxis.   Shortly after vaccination of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9), the patient experienced fainted. The patient sought medical attention. The patient was hospitalized and was prescribed unknown treatment. The outcome of fainted was unknown. The causality between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and fainted was unknown.  Upon internal review, fainted was determined to be medically significant.  This case was a non-valid case, as no reporter's identifier was provided.
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Oropharyngeal pain, Pyrexia
Clinical narrative: Blisters; Sore Throat; Fever of 102+; This case was reported by a consumer and described the occurrence of blister in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in April 2019, 6 months before the 2nd dose almost exactly, 6 months apart).   On 27th September 2019, the patient received the 2nd dose of Shingrix. In October 2019, 30 days after receiving Shingrix, the patient experienced blister, sore throat and fever. On an unknown date, the outcome of the blister, sore throat and fever were unknown.   It was unknown if the reporter considered the blister, sore throat and fever to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The month before the reporting date, the patient received second Shingrix vaccine shot. The patient experienced few blisters and had a fever of more than 102 degree F for a couple days. The patient had been fine ever since the shot. On 27th September 2019, the patient experienced no side effects after the shot. The patient asked wheher roughly a month after the second shot, could this be a side effect. The patient was on his way to the doctor, so if they call he could talk briefly. The patient asked do the side effects occur fairly soon, or could they occur a month later. The patient asked if it was a side effect, is it contagious adn could he spread something to others. The patient was going to a gathering with 100 people this w/e and did not want to spread anything. The patient reported that he had a sore throat. The patient asked whether the side effect were contagious. The patient was not 100 percent  sure this was a side effect.  The patient had zero problems since his first and second shot. A few days ago the patient got a fever, and then 2 blisters on his face, one inside a nostril, and now it appears he had some on my fingers. At first he thought it was a cooking burn, but both hands have one blister, one on my left ring finger and the other on my right thumb.      Lab Comments: On an unknown date the patient's body temperature was recorded as 102+ degree F.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Impaired work ability, Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Bursitis; NOT BEEN ABLE TO RETURN TO WORK SINCE RECEIVING THE VACCINE; Injection site pain; VERY DIFFICULT TO EVEN LIFT A MILK JUG; VERY DIFFICULT TO EVEN LIFT A MILK JUG; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 48-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 3DE4L, expiry date 30th June 2019) for prophylaxis.   On 24th October 2019, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season .5 ml. On 24th October 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site pain, pain upon movement, injected limb mobility decreased and inability to work. On 25th October 2019, the patient experienced bursitis. The patient was treated with prednisone, tramadol and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain, pain upon movement, injected limb mobility decreased, bursitis and inability to work were unknown.   It was unknown if the reporter considered the injection site pain, pain upon movement, injected limb mobility decreased, bursitis and inability to work to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: Around noon, the patient received Fluarix Quadrivalent 2019-2020 season on right arm 2 or 3 fingers down from shoulder joint. Within 2 hours after receiving Fluarix Quadrivalent 2019-2020 season, the patient started having pain at injection site and said that she had pain and it was very difficult to even lift a milk jug. On 25th October 2019, the patient went to urgent care and had x rays done. The patient was given tramadol and told to ice it. 1 day after receiving Fluarix Quadrivalent 2019-2020 season, the urgent care said the patient may be it was bursitis. On 30th October 2019, the patient went to see primary care physician and was prescribed prednisone. 6 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient has not been able to return to work since receiving the vaccine. The patient had been referred to Orthopedic doctor. The patient stated the prednisone has helped as of 1st November 2019
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: X-ray
Clinical narrative: Bursitis; NOT BEEN ABLE TO RETURN TO WORK SINCE RECEIVING THE VACCINE; Injection site pain; VERY DIFFICULT TO EVEN LIFT A MILK JUG; VERY DIFFICULT TO EVEN LIFT A MILK JUG; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 48-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2019-2020 season) (batch number 3DE4L, expiry date 30th June 2019) for prophylaxis.   On 24th October 2019, the patient received the 1st dose of Fluarix Quadrivalent 2019-2020 season .5 ml. On 24th October 2019, less than a day after receiving Fluarix Quadrivalent 2019-2020 season, the patient experienced injection site pain, pain upon movement, injected limb mobility decreased and inability to work. On 25th October 2019, the patient experienced bursitis. The patient was treated with prednisone, tramadol and non-drug therapy (Ice Pack (No Medication)). On an unknown date, the outcome of the injection site pain, pain upon movement, injected limb mobility decreased, bursitis and inability to work were unknown.   It was unknown if the reporter considered the injection site pain, pain upon movement, injected limb mobility decreased, bursitis and inability to work to be related to Fluarix Quadrivalent 2019-2020 season.  Additional details were provided as follows: Around noon, the patient received Fluarix Quadrivalent 2019-2020 season on right arm 2 or 3 fingers down from shoulder joint. Within 2 hours after receiving Fluarix Quadrivalent 2019-2020 season, the patient started having pain at injection site and said that she had pain and it was very difficult to even lift a milk jug. On 25th October 2019, the patient went to urgent care and had x rays done. The patient was given tramadol and told to ice it. 1 day after receiving Fluarix Quadrivalent 2019-2020 season, the urgent care said the patient may be it was bursitis. On 30th October 2019, the patient went to see primary care physician and was prescribed prednisone. 6 days after receiving Fluarix Quadrivalent 2019-2020 season, the patient has not been able to return to work since receiving the vaccine. The patient had been referred to Orthopedic doctor. The patient stated the prednisone has helped as of 1st November 2019
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Extreme itchiness; This case was reported by a nurse via sales rep and described the occurrence of pruritus in a 59-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 3A929, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2019-2020 season .5 ml. On an unknown date, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced pruritus. The patient was treated with prednisone. On an unknown date, the outcome of the pruritus was recovered/resolved.   The reporter considered the pruritus to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. Approximately 4 to 5 hours after vaccination, in the the evening, the patient experienced extreme itchiness. The patient took Prednisone close to bedtime because the itchiness became intolerable. The itchiness lasted about 2 days and was intense. This case has been linked with US2019AMR199254, reported by the same reporter.
Sex: F
Vaccine: FLU4
Symptoms: Pruritus
Clinical narrative: Itchiness in the head; This case was reported by a nurse via sales rep and described the occurrence of pruritus in a 33-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) (batch number 3A929, expiry date unknown) for prophylaxis.   On an unknown date, the patient received FluLaval Tetra 2019-2020 season .5 ml. On an unknown date, less than a day after receiving FluLaval Tetra 2019-2020 season, the patient experienced pruritus. On an unknown date, the outcome of the pruritus was recovered/resolved.   The reporter considered the pruritus to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The age at vaccination was not reported. In the morning, 12 to 16 hours after vaccination, the patient experienced itchiness in the head and next area. The itchiness lasted about 2 days and was intense. This case has been linked with US2019AMR199245, reported by the same reporter.
Age: 65.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Fatigue, Headache, Injected limb mobility decreased, Pain in extremity
Clinical narrative: fatigue; headache; soreness; Unable to life the arm; This case was reported by a consumer via call center representative and described the occurrence of fatigue in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   Previously administered products included Flu shots (received many flu shots in the past and never had a problem with them.).   On 28th October 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml and Influenza vaccine Quadrivalent 2019-2020 season. On 28th October 2019, 5 hrs after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced fatigue, headache, pain in arm and injected limb mobility decreased. On an unknown date, the outcome of the fatigue and headache were not recovered/not resolved and the outcome of the pain in arm and injected limb mobility decreased were recovering/resolving.   The reporter considered the fatigue, headache, pain in arm and injected limb mobility decreased to be related to Shingrix. It was unknown if the reporter considered the fatigue, headache, pain in arm and injected limb mobility decreased to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional case details were provided as follows: At around 3:30, the patient received Shingrix in her left deltoid and a flu shot for senior citizens in her right arm. In the evening, the patient developed headache and some fatigue. The fatigue was so bad on the day of reporting that she had to cancel her plans.  She also said on the day of vaccination, her arm became so sore and she was unable to lift it but now it was much better. She never got headaches and never had an issue with any previous flu shots so she attributed her side effects to Shingrix. The patient did not consent to follow-up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: PAIN; Injection site pain; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st September 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 1st September 2019, less than a day after receiving Shingrix, the patient experienced injected limb mobility decreased and injection site pain. On 2nd September 2019, the outcome of the injected limb mobility decreased and injection site pain were recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased and injection site pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in the left arm. The patient experienced pain at the injection site at the time of receiving Shingrix. Her arm was incapacitated for that day. The reporter did not consent to follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest pain, Pain
Clinical narrative: Pain across her chest when she breathes; shoulder blade under her arm she developed pain; This case was reported by a consumer via call center representative and described the occurrence of pain in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included psoriatic arthritis (had trouble with arthritis). Concomitant products included infliximab (Remicade).   On 28th October 2019, the patient received the 1st dose of Shingrix. On 29th October 2019, 1 days after receiving Shingrix, the patient experienced pain. On 1st November 2019, the patient experienced chest pain. On an unknown date, the outcome of the pain was not recovered/not resolved and the outcome of the chest pain was unknown.   It was unknown if the reporter considered the pain and chest pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix in right arm. The next morning near her right shoulder blade under her arm, she developed pain. On the day of reporting, she reported it had moved to the left side in her back she also felt referred pain across her chest when she breathes. Caller reports having trouble with arthritis and was unsure of pain causality. The reporter consented to follow up.
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Dysgeusia, Feeling abnormal, Hepatitis B antibody negative, Malaise, Migraine
Clinical narrative: Migraine; Terrible metallic taste; Didn't feel good; Low titers; High temperature; Felt lousy; This case was reported by a nurse via call center representative and described the occurrence of migraine in a female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine, the 1st dose of Hepatitis B vaccine and the 2nd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine and not applicable after receiving Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced migraine, taste metallic, feeling unwell, therapeutic response decreased, high temperature and feeling bad. On an unknown date, the outcome of the migraine, taste metallic, feeling unwell, therapeutic response decreased, high temperature and feeling bad were unknown.   It was unknown if the reporter considered the migraine, taste metallic, feeling unwell, therapeutic response decreased, high temperature and feeling bad to be related to Hepatitis B vaccine. It was unknown if the reporter considered the therapeutic response decreased to be related to Hepatitis B vaccine and Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a temperature and felt lousy after receiving her third dose. The patient had to have titers drawn, and after 3-4 years following series completion, titers were low. The patient only received only 0.05ml of Hepatitis B vaccine and experienced a migraine, terrible metallic taste and did not feel good at all. The patient consented to follow up.      Lab Comments: On an unknown date lab test was performed
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Pyrexia, Therapeutic response decreased
Clinical narrative: Migraine; Terrible metallic taste; Didn't feel good; Low titers; High temperature; Felt lousy; This case was reported by a nurse via call center representative and described the occurrence of migraine in a female patient who received Hepatitis B vaccine for prophylaxis.   Co-suspect products included Hepatitis B vaccine for prophylaxis and Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received the 3rd dose of Hepatitis B vaccine, the 1st dose of Hepatitis B vaccine and the 2nd dose of Hepatitis B vaccine. On an unknown date, unknown after receiving Hepatitis B vaccine and not applicable after receiving Hepatitis B vaccine and Hepatitis B vaccine, the patient experienced migraine, taste metallic, feeling unwell, therapeutic response decreased, high temperature and feeling bad. On an unknown date, the outcome of the migraine, taste metallic, feeling unwell, therapeutic response decreased, high temperature and feeling bad were unknown.   It was unknown if the reporter considered the migraine, taste metallic, feeling unwell, therapeutic response decreased, high temperature and feeling bad to be related to Hepatitis B vaccine. It was unknown if the reporter considered the therapeutic response decreased to be related to Hepatitis B vaccine and Hepatitis B vaccine.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a temperature and felt lousy after receiving her third dose. The patient had to have titers drawn, and after 3-4 years following series completion, titers were low. The patient only received only 0.05ml of Hepatitis B vaccine and experienced a migraine, terrible metallic taste and did not feel good at all. The patient consented to follow up.      Lab Comments: On an unknown date lab test was performed
Sex: F
Vaccine: VARZOS
Symptoms: Dyspepsia, Rash
Clinical narrative: Rash on the left arm; Severe heartburn; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a female patient who received Herpes zoster (Shingrix) (batch number M9P52, expiry date 18th December 2021) for prophylaxis.   Concomitant products included INFLUENZA VIRUS VACCINE INACTIVATED (FLUZONE (SEASONAL INFLUENZA VACCINE)).   On 22nd October 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 2 weeks after receiving Shingrix, the patient experienced rash and heartburn. On an unknown date, the outcome of the rash and heartburn were unknown.   It was unknown if the reporter considered the rash and heartburn to be related to Shingrix.  Additional case details were reported as follows: The healthcare professional declined to leave additional patient demographics. The age at vaccination was not reported. The reporter also noted that the patient received Fluzone in the right arm 15 days prior. The patient received vaccine in her right arm and a rash developed on the left arm. The patient also reported severe heartburn.  The reporter consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Weight decreased
Clinical narrative: Weight Loss; This case was reported by a other health professional via call center representative and described the occurrence of weight loss in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced weight loss. On an unknown date, the outcome of the weight loss was unknown.   It was unknown if the reporter considered the weight loss to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that the patient experienced weight loss after the first dose of Shingles vaccine. The reporter was asked about what are the side effects of Shingrix vaccine for Shingles and dose it cause weight loss in elderly people. The reporter did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea, Pyrexia, Vomiting
Clinical narrative: Injection site pain; Nausea; Throwing up; Fever; This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 22nd August 2019 and experienced injection site pain).   On 6th November 2019, the patient received the 2nd dose of Shingrix. In November 2019, less than a week after receiving Shingrix, the patient experienced injection site pain, nausea, vomiting and fever. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the injection site pain, nausea, vomiting and fever were unknown.   It was unknown if the reporter considered the injection site pain, nausea, vomiting and fever to be related to Shingrix.  Additional details were provided as follows: The patient after vaccination experienced throwing up, nausea, fever and pain at the injection site. This case has been linked with case US2019AMR203530, reported by the same reporter.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Catheterisation cardiac, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: rising area; rising area that is hot to touch; Red / arm has red; This case was reported by a pharmacist via call center representative and described the occurrence of injection site swelling in a 67-year-old female patient who received Herpes zoster (Shingrix) (batch number 52R7X, expiry date 10th October 2021) for prophylaxis.   Previously administered products included Shingrix (1st dose received on unknown date and no reaction to the first dose.).   On 5th November 2019, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 5th November 2019, less than a day after receiving Shingrix, the patient experienced injection site swelling, injection site warmth and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site warmth and injection site erythema were not recovered/not resolved.   It was unknown if the reporter considered the injection site swelling, injection site warmth and injection site erythema to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. The patient's arm had red, rising area that was hot to touch (at the injection site). It started in the afternoon of the injection and was about the same. The patient would also having a heart catheter a day after reporting, noted in report in case significant for reporting. The reporter consent to follow up.
Age: 57.0
Sex: F
Vaccine: FLU4, TD
Symptoms: Biopsy skin abnormal, Eczema, Rash, Rash erythematous, Rash papular
Clinical narrative: Also received: on 9/4/2019 SHIGRIX Lot#4RR52 Exp 12/7/20121 left arm and PREVNAR13 lot#39679 Exp 10/31/2020 right arm at physicians 9/11 reported a rash that she thought was infected hair folicles on righ calf. Started on Triamcinilone cream and 10 day course of Amoxicillin. Over the next 2 weeks had more spots of rash, red, some raised on all extremities, buttocks, back and abdomen. Was given a steroid boost of 400MG and a punch biopsy performed which resulted in spongiotic dermatitis. Currently using baby AVENO to keep moist (OTC). Denies pain, denies drainage. Today rash on all extremities and back, abdomen, buttocks, chest. Differing shades of red, some raised, some appear scabbed. Has a follow up appointment schedule with DR on November 20, 2019
Age: 57.0
Sex: F
Vaccine: FLU4, TD
Symptoms: Scab
Clinical narrative: Also received: on 9/4/2019 SHIGRIX Lot#4RR52 Exp 12/7/20121 left arm and PREVNAR13 lot#39679 Exp 10/31/2020 right arm at physicians 9/11 reported a rash that she thought was infected hair folicles on righ calf. Started on Triamcinilone cream and 10 day course of Amoxicillin. Over the next 2 weeks had more spots of rash, red, some raised on all extremities, buttocks, back and abdomen. Was given a steroid boost of 400MG and a punch biopsy performed which resulted in spongiotic dermatitis. Currently using baby AVENO to keep moist (OTC). Denies pain, denies drainage. Today rash on all extremities and back, abdomen, buttocks, chest. Differing shades of red, some raised, some appear scabbed. Has a follow up appointment schedule with DR on November 20, 2019
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Epistaxis, Full blood count, Immune thrombocytopenic purpura, Metabolic function test, Rectal haemorrhage
Clinical narrative: patient had episodes of bleeding from nose and rectally, diagnosed with ITP
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Urine analysis
Clinical narrative: patient had episodes of bleeding from nose and rectally, diagnosed with ITP
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Feeling hot, Flushing, Pain, Vomiting
Clinical narrative: Received vaccine on Wed 11/6, and on Thur 11/7 experienced body aches, fatigue, vomited once, feeling flushed and warm but didn't have a fever (took temperature it was normal, this lasted till Friday afternoon.
Age: 65.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain
Clinical narrative: The arm was very sore for several weeks but was localized in the area of the shot. the pain did not radiate to the shoulder.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Blister, Headache, Myalgia, Pyrexia, Scab
Clinical narrative: The day after she received her vaccine she noticed a blister approximately three inches posterior to the site of the vaccine injection.  The blister popped and oozed serosanguinous fluid.  She reported to the occupational health clinic on 11/11/19.  Blistered area has crusted over, no current signs of drainage, no cellulitis noticed around blister.   She also reports headache, mild fever and myalgia on 11/6/19 which resolved within 24 hours.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Secretion discharge
Clinical narrative: The day after she received her vaccine she noticed a blister approximately three inches posterior to the site of the vaccine injection.  The blister popped and oozed serosanguinous fluid.  She reported to the occupational health clinic on 11/11/19.  Blistered area has crusted over, no current signs of drainage, no cellulitis noticed around blister.   She also reports headache, mild fever and myalgia on 11/6/19 which resolved within 24 hours.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Hyperhidrosis, Nasopharyngitis, Rhinorrhoea
Clinical narrative: Unknown influenza vaccine: ?Influenza vaccine (inactive) 0.5 mL High-Dose?. One injection into left arm. Outcomes: coughing (<1 day), wheezing (<1 day), runny nose (<1 day), chills (several minutes), usually high perspiration  (several minutes). Patient contracted a common cold from 10/12/19-11/8/19.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Wheezing
Clinical narrative: Unknown influenza vaccine: ?Influenza vaccine (inactive) 0.5 mL High-Dose?. One injection into left arm. Outcomes: coughing (<1 day), wheezing (<1 day), runny nose (<1 day), chills (several minutes), usually high perspiration  (several minutes). Patient contracted a common cold from 10/12/19-11/8/19.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Swelling
Clinical narrative: REDNESS, SWELLING, ITCHINESS
Age: 81.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: PATIENT CALLED STATING HIS ARM HAS BEEN HURTING SINCE RECEIVING THE VACCINATION ON OCT 7. HE WAS INSTRUCTED TO BE SEEN BY A HEALTH CARE PROFESSIONAL WHO COULD ASSESS HIS CONDITION AND REPORT BACK TO US ASAP.
Age: 65.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Arthralgia, Injection site pain, Myalgia, Neurological symptom, Pain in extremity
Clinical narrative: Having  pain that feels muscular at times and nerve related symptoms. Pain is in right shoulder, arm & radiates down to wrist, NOT numbness & tingling .
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site rash, Pruritus, Rash
Clinical narrative: rash that started around the site and spread over his entire body. lasted 3 months was itchy and seen several times in office
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Wrong product administered
Clinical narrative: Patient received a 2nd Prevnar vaccine on 11/1/19 when he should have gotten Pneumovax
Age: 54.0
Sex: F
Vaccine: RAB
Symptoms: Anxiety, Dizziness, Dysphagia, Dyspnoea, Pruritus
Clinical narrative: Signs and symptoms on-site: anxiety, lightheadedness/dizziness, shortness of breath, difficulty swallowing.   About 12 minutes after receiving a Rabies immunization, the donor reported experiencing difficult swallowing and difficulty breathing. 50 mg of Benadryl PO was administered, and paramedics were called.. Respiration rate 14 breaths per minutes. After about 5 minutes donor stated symptoms began to resolve.  Paramedics arrived and donor released to paramedics.  Donor transported to hospital in stable condition.  Follow-up with donor on 3/20/18: Donor stated she also experienced itching and had hives noted at the hospital. But, she felt fine and left hospital same day. Donor was not prescribed medications and denied taking anything for the reaction after leaving the plasm center. Per donor, all symptoms resolved by the next morning (after immunization).
Age: 54.0
Sex: F
Vaccine: RAB
Symptoms: Urticaria
Clinical narrative: Signs and symptoms on-site: anxiety, lightheadedness/dizziness, shortness of breath, difficulty swallowing.   About 12 minutes after receiving a Rabies immunization, the donor reported experiencing difficult swallowing and difficulty breathing. 50 mg of Benadryl PO was administered, and paramedics were called.. Respiration rate 14 breaths per minutes. After about 5 minutes donor stated symptoms began to resolve.  Paramedics arrived and donor released to paramedics.  Donor transported to hospital in stable condition.  Follow-up with donor on 3/20/18: Donor stated she also experienced itching and had hives noted at the hospital. But, she felt fine and left hospital same day. Donor was not prescribed medications and denied taking anything for the reaction after leaving the plasm center. Per donor, all symptoms resolved by the next morning (after immunization).
Age: 50.0
Sex: F
Vaccine: UNK
Symptoms: Arthralgia, Fatigue, Headache, Pain in extremity
Clinical narrative: Soreness in the arm occurred within an hour of the vaccine administration lasting 2 days, headache set in for 3rd and 4th day, body aches in knees and ankles plus fatigue for 5th through 7th day
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Abnormal behaviour, Chest X-ray normal, Cytogenetic analysis, Decreased appetite, Generalised tonic-clonic seizure
Clinical narrative: Child received Infanrix and Havrix IM on 10/30/19 IM in Right Vastus Lateralis around 9AM. He started with a low-grade fever around 4pm of 99 degrees. It did elevate to 101.6 per ear thermometer later Wednesday night. Mom gave him Tylenol throughout the night. On 10/31 the fever remained around 99 degrees. He was not himself. No real appetite. By 2pm, the child started having a seizure. EMS was called and he was taken by ambulance to the ER. His seizure lasted a total of 90 minutes from start to finish. The ER doctor felt this was a Grand Mal type seizure. He had an MRI, chest x-ray and spinal tap to rule out infectious nature for seizure. All were negative and no meningitis was noted. Genetic testing has been done and results are pending. Child is on anti-seizure medication and being followed by a Pediatric Neurologist- Dr. No further seizure activity for the child when mom called on 11/5/2019. Child's activity was back to normal.
Age: 1.58
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Lumbar puncture normal, Magnetic resonance imaging brain normal, Pyrexia, Seizure
Clinical narrative: Child received Infanrix and Havrix IM on 10/30/19 IM in Right Vastus Lateralis around 9AM. He started with a low-grade fever around 4pm of 99 degrees. It did elevate to 101.6 per ear thermometer later Wednesday night. Mom gave him Tylenol throughout the night. On 10/31 the fever remained around 99 degrees. He was not himself. No real appetite. By 2pm, the child started having a seizure. EMS was called and he was taken by ambulance to the ER. His seizure lasted a total of 90 minutes from start to finish. The ER doctor felt this was a Grand Mal type seizure. He had an MRI, chest x-ray and spinal tap to rule out infectious nature for seizure. All were negative and no meningitis was noted. Genetic testing has been done and results are pending. Child is on anti-seizure medication and being followed by a Pediatric Neurologist- Dr. No further seizure activity for the child when mom called on 11/5/2019. Child's activity was back to normal.
Age: 28.0
Sex: F
Vaccine: FLUR4
Symptoms: Erythema, Feeling abnormal, Injection site erythema, Injection site inflammation, Injection site warmth
Clinical narrative: On 11/8/19 patient/employee came to work at approx 1745 and was found to have red, warm inflammation to left arm/deltoid around site of injection (11/5/19) as noticed by charge nurse and HR rep.  Contacted RN, Employee Health Nurse who was told by employee that her Lupus MD advised her to go to ED instead of work.  She decided instead to report to work.  She was complaining of feeling generally bad, feverish and had pain, warmth and redness to left arm that started about 24 hours after injection.     Employee immediately released from work and sent to ED.  Followed up with employee in ED who was seen by ED physician at approx 2000.  Released from ED on Bactrim.  Followed up with Lupus MD next day.  Was treated with steroids and told to return to work Sunday.  Followed up with employee Sunday 11/10/19 and was told she had fever of 102 but arm had improved greatly.  She notified her MD of this and was told by MD not to return to work until fever is below 99.  Employee excused from work, told to stay home until fevers under control per MD orders.  She stated that she has appt to follow up with Lupus MD on 11/11/19 and that this event was being treated as a Lupus flair that she has experienced prior, but never as the result of an immunization.
Age: 28.0
Sex: F
Vaccine: FLUR4
Symptoms: Loss of personal independence in daily activities, Pain in extremity, Pyrexia, Skin warm
Clinical narrative: On 11/8/19 patient/employee came to work at approx 1745 and was found to have red, warm inflammation to left arm/deltoid around site of injection (11/5/19) as noticed by charge nurse and HR rep.  Contacted RN, Employee Health Nurse who was told by employee that her Lupus MD advised her to go to ED instead of work.  She decided instead to report to work.  She was complaining of feeling generally bad, feverish and had pain, warmth and redness to left arm that started about 24 hours after injection.     Employee immediately released from work and sent to ED.  Followed up with employee in ED who was seen by ED physician at approx 2000.  Released from ED on Bactrim.  Followed up with Lupus MD next day.  Was treated with steroids and told to return to work Sunday.  Followed up with employee Sunday 11/10/19 and was told she had fever of 102 but arm had improved greatly.  She notified her MD of this and was told by MD not to return to work until fever is below 99.  Employee excused from work, told to stay home until fevers under control per MD orders.  She stated that she has appt to follow up with Lupus MD on 11/11/19 and that this event was being treated as a Lupus flair that she has experienced prior, but never as the result of an immunization.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Herpes zoster, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Pain and swelling at injection site that did not subside, nausea and dizziness developed later that night, then had an outbreak of shingles 2 weeks following the vaccine
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, C-reactive protein, Full blood count, Hypoaesthesia, Metabolic function test
Clinical narrative: L arm pain, weakness both arms, burning sensation, shakiness; now 2 months out still having this pain - persisting, occasional shakiness when going to write, numbness in hands
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Pain in extremity, Red blood cell sedimentation rate, Tremor
Clinical narrative: L arm pain, weakness both arms, burning sensation, shakiness; now 2 months out still having this pain - persisting, occasional shakiness when going to write, numbness in hands
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse effect; administration of one dose of an improperly stored vaccine, ROTATEQ, to one patient; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's concurrent conditions, medical history, concomitant medications and drug reactions/allergies were not reported. On 05-NOV-2019, the patient was vaccinated with a dose of improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) vaccine, 2 millilitre, given once via route defaulted to oral for prophylaxis (lot # S005874 and expiration date: 31-OCT-2020) (product storage error). The administered dose of the vaccine experienced temperature excursion at 9.1ºC for a timeframe of 22 minutes. There was no previous temperature excursion. The call was due to digital data logger. No adverse effects were reported. The outcome of product storage error was unknown.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a nurse via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, several days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional case details were reported as follows: The healthcare professional did not have the date of vaccination or the vaccine lot number and expiry date. The patient received the 1st dose of Shingrix and developed shingles a few days later. The vaccine was not administered with this healthcare professional. The reporter consent to follow up.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Eye pain, Headache, Herpes zoster, Polymerase chain reaction
Clinical narrative: Shingles; left eye pain; pain on her head at the level of her eye; pain moving toward her ear; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 16th October 2019, the patient received the 1st dose of Shingrix. On 23rd October 2019, 7 days after receiving Shingrix, the patient experienced shingles, eye pain, headache and ear pain. The patient was treated with antivirals nos. On an unknown date, the outcome of the shingles was not recovered/not resolved and the outcome of the eye pain, headache and ear pain were unknown.   It was unknown if the reporter considered the shingles, eye pain, headache and ear pain to be related to Shingrix.  Additional case details were reported as follows: The patient received vaccine in right arm. 1 week after vaccination, patient had continuous painful left eye pain and she also had pain on her head at the level of her eye and then moving toward her ear. The patient saw a neurologist who diagnosed Shingles, she was on an antiviral at the time of reporting. The polymerase chain reaction test was negative but doctor still thought it was shingles. The reporter consent to follow up.
Age: 59.0
Sex: F
Vaccine: FLUC4
Symptoms: Abdominal pain lower, Ultrasound scan vagina
Clinical narrative: PATIENT STATES DEVELOPED SEVERE ABDOMINAL PAIN 3-4 DAYS AFTER VACCINATION IN RIGHT LOWER QUADRANT.  SHE STATES SHE THOUGHT IT WAS A PROBLEM WITH HER OVARIES BECAUSE OF THE SEVERITY AND LOCATION.  THIS PROMPTED HER TO HAVE A TRANSVAGINAL ULTRASOUND DONE TO INVESTIGATE THROUGH HER PCP.  PT STATES PAIN LASTED ABOUT 2 WEEKS AND RESOLVED.
Age: 71.0
Sex: F
Vaccine: DTAP
Symptoms: Pain, Pain in extremity
Clinical narrative: Deep, dull pain in left arm and pain in arm movement
Age: 26.0
Sex: F
Vaccine: RAB
Symptoms: Muscle spasms
Clinical narrative: On 10/01/19, the donor reported that the day after receiving a previous Rabies vaccination (3/8/19) she experienced a back spasm.  She also experienced spasms two more times and did not recall the dates.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Dizziness, Fatigue, Headache, Influenza like illness
Clinical narrative: 48 hours of muscle and joint aches similar to those with a flu. Very mild nausea.  Exhaustion. Skin was stinging.  Intermittent pains in head. Not headache.  Followed by mild dizziness and continued fatigue from the 48 hour mark until today.  I have recovered from the worst of the symptoms but continue to feel some fatigue and upper left arm injection site still red, swollen, sore and itchy.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: 48 hours of muscle and joint aches similar to those with a flu. Very mild nausea.  Exhaustion. Skin was stinging.  Intermittent pains in head. Not headache.  Followed by mild dizziness and continued fatigue from the 48 hour mark until today.  I have recovered from the worst of the symptoms but continue to feel some fatigue and upper left arm injection site still red, swollen, sore and itchy.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pain of skin
Clinical narrative: 48 hours of muscle and joint aches similar to those with a flu. Very mild nausea.  Exhaustion. Skin was stinging.  Intermittent pains in head. Not headache.  Followed by mild dizziness and continued fatigue from the 48 hour mark until today.  I have recovered from the worst of the symptoms but continue to feel some fatigue and upper left arm injection site still red, swollen, sore and itchy.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Increase pain, redness, swelling to left arm without drainage. Pain and swelling has continued to worsen over time. Erythema is blanchable. Treated for possible cellulitis and reaction.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Loss of consciousness, Vomiting
Clinical narrative: PT RECEIVED HER VACCINE AND THEN WENT TO SIT FOR A WHILE.  AFTER 15-20 MINUTES SHE GOT UP AND WENT SHOPPING WITH HER FAMILY.  THEY RETURNED BACK LATER AND SAID SHE HAD PASSED OUT INTO HER MOTHER'S ARMS.  SHE VOMMITED INTO THE TRASHCAN AND PHARMACIST STAYED WITH HER TO MAKE SURE SHE WAS OK FOR AROUND 30 MINUTES.  HE GOT HER SOME WATER AND HAD HER CONTINUE TO SIT IN THE IMMUNIZATION AREA.  SHE SAID SHE WAS FEELING BETTER AFTER SOME TIME AND LEFT.  SHE ASKED THAT HER NAME NOT BE MENTIONED TO THE REPORTING SYSTEM.  PHARMACIST CALLED HER THE NEXT DAY AND SHE SAID SHE WAS STILL FEELING FIND, BUT STILL DID NOT WANT HER NAME REPORTED TO SYSTEM.
Age: 68.0
Sex: F
Vaccine: FLUC4, PPV
Symptoms: Injection site erythema, Injection site swelling, Pain
Clinical narrative: Patient reports that her left arm, where she received the pneumonia vaccine started swelling the day of the vaccination. It is about 5 inch swelling with redness around injection site.  She reports it was severely painful to lift her arm but it has since resolved.
Sex: M
Vaccine: HPV9
Symptoms: Splenectomy
Clinical narrative: The patient had completed the GARDASIL 9 series and has now undergone a splenectomy; This spontaneous report was received from a pharmacist technician/student referring to a male patient of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant medication, drug reactions and allergies were unknown by reporter.       On an unknown date, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) intramuscular for prophylaxis (strength, dose, frequency, anatomical location, lot number and expiration date were not reported).         The reporter stated that, on an unspecified date, the patient had completed the hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) series. On an unknown date, the patient sought medical attention and was admitted to the hospital, as he underwent a splenectomy at the reporter's facility. It was unknown if laboratory diagnostics/studies were performed or if treatment was given for the event. The outcome of splenectomy was unknown.      The causality assessment between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the aforementioned event was not reported.
Sex: U
Vaccine: VARZOS
Symptoms: Body temperature increased, Feeling abnormal, Headache, Malaise
Clinical narrative: Malaise; Headache; draggy/ feel as draggy; Possibly a slightly elevated temp; This case was reported by a consumer and described the occurrence of malaise in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 31st October 2019, the patient received Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced malaise, headache, feeling abnormal and body temperature increased. On an unknown date, the outcome of the malaise, headache, feeling abnormal and body temperature increased were unknown.   It was unknown if the reporter considered the malaise, headache, feeling abnormal and body temperature increased to be related to Shingrix.  Additional case details were reported as follows: The age at vaccination was not reported. The patient had shingle ricks vaccination last evening, from day of vaccination. The patient felt malaise, headache on day of reporting and enquired how long does that typically last. The patient reported possibly a slightly elevated temperature. The patient was surprised to feel as draggy and headachy on day of reporting. The follow up was not required.