chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU4, PPV
Symptoms: Malaise, Nausea, Neuralgia, Pain, Pain in extremity
Clinical narrative: her arm blew up; redness at injection site/ below the injection site; tingles arm; the nerves of her arm were irritated; arm still hurts; Labelled drug-drug interaction medication error; Allergic reaction; flu-like symptoms; sick for 3 days/ she still felt cruddy; fever; chills; achiness; exhaustion; nausea; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a adult female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX 23) for prophylaxis.   On 24th September 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular) and PNEUMOVAX 23. In September 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced sickness, chills, pain, exhaustion and nausea. On 26th September 2019, the patient experienced allergic reaction, influenza-like symptoms and fever. On an unknown date, the patient experienced swelling arm, erythema, tingling, neuralgia, pain in arm and labeled drug-drug interaction medication error. On an unknown date, the outcome of the allergic reaction and labeled drug-drug interaction medication error were unknown and the outcome of the influenza-like symptoms was resolved with sequelae and the outcome of the sickness, fever, chills, pain, exhaustion and nausea were recovered/resolved and the outcome of the swelling arm, erythema, tingling, neuralgia and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, influenza-like symptoms, sickness, fever, chills, pain, exhaustion, nausea, swelling arm, erythema, tingling, neuralgia and pain in arm to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patients birth date was reported as 16th July (no year reported). The patient was vaccinated with FluLaval Tetra and Pneumovax 23 on the same day in left deltoid, side by side, about 2 inches apart. The vaccine FluLaval Tetra was given by pre filled syringe intramuscularly. Post vaccination the patient was sick for 3 days. The patient elaborated the symptoms as fever, chills, achiness, exhaustion, and nausea. On 26th September 2019, the patient's fever broke but she felt cruddy for the next 3 days. Till the time of reporting the patient's arm was not right. The patient stated that her arm blew up, was red and it still tingles and hurted. The patient thought that maybe the nerves of her arm were irritated.  The patient said this occurred below the injection site. The patient wanted to know the ingredients in FLULAVAL Quadrivalent 2019-2020 Season because she feels that she may have had an allergic reaction to it or the Pneumovax 23. The reporter consented to follow up.
Sex: F
Vaccine: FLU4, PPV
Symptoms: Peripheral swelling, Pyrexia, Tinea capitis
Clinical narrative: her arm blew up; redness at injection site/ below the injection site; tingles arm; the nerves of her arm were irritated; arm still hurts; Labelled drug-drug interaction medication error; Allergic reaction; flu-like symptoms; sick for 3 days/ she still felt cruddy; fever; chills; achiness; exhaustion; nausea; This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a adult female patient who received Flu Seasonal QIV Quebec (FluLaval Tetra 2019-2020 season) for prophylaxis.   Co-suspect products included PNEUMOCOCCAL VACCINE POLYSACCHARIDE 23 VALENT (PNEUMOVAX 23) for prophylaxis.   On 24th September 2019, the patient received FluLaval Tetra 2019-2020 season (intramuscular) and PNEUMOVAX 23. In September 2019, less than a week after receiving FluLaval Tetra 2019-2020 season, the patient experienced sickness, chills, pain, exhaustion and nausea. On 26th September 2019, the patient experienced allergic reaction, influenza-like symptoms and fever. On an unknown date, the patient experienced swelling arm, erythema, tingling, neuralgia, pain in arm and labeled drug-drug interaction medication error. On an unknown date, the outcome of the allergic reaction and labeled drug-drug interaction medication error were unknown and the outcome of the influenza-like symptoms was resolved with sequelae and the outcome of the sickness, fever, chills, pain, exhaustion and nausea were recovered/resolved and the outcome of the swelling arm, erythema, tingling, neuralgia and pain in arm were not recovered/not resolved.   It was unknown if the reporter considered the allergic reaction, influenza-like symptoms, sickness, fever, chills, pain, exhaustion, nausea, swelling arm, erythema, tingling, neuralgia and pain in arm to be related to FluLaval Tetra 2019-2020 season.  Additional details were provided as follows: The patients birth date was reported as 16th July (no year reported). The patient was vaccinated with FluLaval Tetra and Pneumovax 23 on the same day in left deltoid, side by side, about 2 inches apart. The vaccine FluLaval Tetra was given by pre filled syringe intramuscularly. Post vaccination the patient was sick for 3 days. The patient elaborated the symptoms as fever, chills, achiness, exhaustion, and nausea. On 26th September 2019, the patient's fever broke but she felt cruddy for the next 3 days. Till the time of reporting the patient's arm was not right. The patient stated that her arm blew up, was red and it still tingles and hurted. The patient thought that maybe the nerves of her arm were irritated.  The patient said this occurred below the injection site. The patient wanted to know the ingredients in FLULAVAL Quadrivalent 2019-2020 Season because she feels that she may have had an allergic reaction to it or the Pneumovax 23. The reporter consented to follow up.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Incorrect route of product administration, Injection site erythema, Injection site swelling, Peripheral swelling
Clinical narrative: was inadvertently given dose 2 of Shingrix subcutaneously; swollen arm; red arm; This case was reported by a pharmacist via call center representative and described the occurrence of swelling arm in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 7AN44, expiry date 30th April 2021) for prophylaxis.   On 16th December 2019, the patient received the 2nd dose of Shingrix (subcutaneous) .5 ml. In December 2019, less than a week after receiving Shingrix, the patient experienced swelling arm and erythema of extremities. On 16th December 2019, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the swelling arm, erythema of extremities and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the swelling arm and erythema of extremities to be related to Shingrix.  Additional details were provided as follows: The patient experienced red swollen arm  around the injection site. The patient inadvertently received Shingrix subcutaneously instead of intramuscularly, which led to formulation administered by other route. The reporter did not consent to follow-up. The reporter declined for the follow-up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Insomnia, Loss of personal independence in daily activities, Pain
Clinical narrative: Fatigue; she needed to sleep but could not sleep; Extreme Body Pain; not being able to do normal activities; Headache; Arm Pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2019 16:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 12th December 2019 19:00, 3 hrs after receiving Shingrix, the patient experienced pain in arm. On 13th December 2019, the patient experienced general body pain, activities of daily living impaired and occipital headache. On 14th December 2019, the patient experienced fatigue and sleeplessness. On 15th December 2019, the outcome of the pain in arm, general body pain and fatigue were resolved with sequelae and the outcome of the activities of daily living impaired and sleeplessness were recovered/resolved. On an unknown date, the outcome of the occipital headache was recovering/resolving.   It was unknown if the reporter considered the pain in arm, general body pain, activities of daily living impaired, occipital headache, fatigue and sleeplessness to be related to Shingrix.  Additional details were provided as follows: On the day of vaccination around 7 to 8 pm, the patient's arm started to hurt. A day post vaccination, the patient had extreme body pain from head to toe and laid out on couch due to not being able to do normal activities and headache.  The patient described headache on the back of her head near her neck that extends to both ears and worsened when bending over as pressure was felt. The following day, the patient still suffered with body pain. Two days post vaccination, the patient had fatigue described as feeling like she needed to sleep but could not sleep. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Fatigue; she needed to sleep but could not sleep; Extreme Body Pain; not being able to do normal activities; Headache; Arm Pain; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th December 2019 16:00, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 12th December 2019 19:00, 3 hrs after receiving Shingrix, the patient experienced pain in arm. On 13th December 2019, the patient experienced general body pain, activities of daily living impaired and occipital headache. On 14th December 2019, the patient experienced fatigue and sleeplessness. On 15th December 2019, the outcome of the pain in arm, general body pain and fatigue were resolved with sequelae and the outcome of the activities of daily living impaired and sleeplessness were recovered/resolved. On an unknown date, the outcome of the occipital headache was recovering/resolving.   It was unknown if the reporter considered the pain in arm, general body pain, activities of daily living impaired, occipital headache, fatigue and sleeplessness to be related to Shingrix.  Additional details were provided as follows: On the day of vaccination around 7 to 8 pm, the patient's arm started to hurt. A day post vaccination, the patient had extreme body pain from head to toe and laid out on couch due to not being able to do normal activities and headache.  The patient described headache on the back of her head near her neck that extends to both ears and worsened when bending over as pressure was felt. The following day, the patient still suffered with body pain. Two days post vaccination, the patient had fatigue described as feeling like she needed to sleep but could not sleep. The reporter consented to follow up.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Diarrhoea, Injection site induration, Injection site pain, Injection site rash
Clinical narrative: Reddened rash around injection site - no swelling or bruising noted. C/O pain (L) arm from elbow up into (L) side of neck radiating to (L) site up back. Injection site & reddened area hard to touch. Reported nausea & diarrhea on 1/1/20 - started around 5pm
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Nausea, Neck pain
Clinical narrative: Reddened rash around injection site - no swelling or bruising noted. C/O pain (L) arm from elbow up into (L) side of neck radiating to (L) site up back. Injection site & reddened area hard to touch. Reported nausea & diarrhea on 1/1/20 - started around 5pm
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Injection site erythema, Injection site swelling, Myalgia, Pain
Clinical narrative: About 2-3 hours following the injection, my arm was sore down to my wrist.  I could not raise my arm without pain. I've never had a poor reaction to vaccinations before. I couldn't get comfortable to sleep that night. I'm a dental hygienist and if I had to work chairside the next day I would not have been able to. By morning, my arm was very red, not at the injection site, but several inches below it - basically my biceps, including the underside of my arm and up into my shoulder. By day two, it was still red and swollen. The margins around the areas were very distinct and raised. But, the pain was greatly diminished and I was able to see patients. The muscles in my arm were sore for a few more days, but manageable.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity
Clinical narrative: About 2-3 hours following the injection, my arm was sore down to my wrist.  I could not raise my arm without pain. I've never had a poor reaction to vaccinations before. I couldn't get comfortable to sleep that night. I'm a dental hygienist and if I had to work chairside the next day I would not have been able to. By morning, my arm was very red, not at the injection site, but several inches below it - basically my biceps, including the underside of my arm and up into my shoulder. By day two, it was still red and swollen. The margins around the areas were very distinct and raised. But, the pain was greatly diminished and I was able to see patients. The muscles in my arm were sore for a few more days, but manageable.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: c/o arm hurting more so than other times received injection, Determined by MD that injection may have been given to high and nicked the bursa. Patient had ROM but states that the shoulder hurt. Patient was placed on Naproxen twice daily
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Nausea
Clinical narrative: Headache and nausea lasting 1 day
Age: 5.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling abnormal, Hallucination, visual, Migraine, Neurological examination normal
Clinical narrative: A couple hours after the immunization, patient reported that everything seemed very small (almost Alice in Wonderland Syndrome-like).  Episode lasted for approx. 10 minutes  Seen in clinic a few hours after that and had normal neurological exam and normal mentation for age.  .  Happened a few more times also with brief duration and complete resolution-total 5 episodes on day of flu vaccine.   Reportedly had another episode a couple days later, then on e episode a week later than the last episode approx. 1 month later.  Described seeing a castle or Jack in the bean stalk during one of the later episodes and also reportedly had one episode (recorded on video) where she was coloring outside the lines then when over, she could color inside the lines.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Pt had shingrix (L) deltoid on 11/25/2019 - developed itching 2 days later - initially at injxn site - no rash - has had itching all over since then w/ no rash - No other new meds, soaps, detergents, soaps -.
Sex: U
Vaccine: PPV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; unspecified patients were administered a dose of PNEUMOVAX23 that experienced a temperature excursion; This spontaneous report was received from a nurse prescriber referring to an unspecified patients of unknown age and gender. The patients pertinent concurrent conditions, medical history, concomitant medications and previous drug reactions or allergies were not reported.  On an unspecified date in 2019 (reported as after February 2019), the patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) as prophylaxis (concentration, number of administered dose, vaccination scheme frequency, route and anatomical location of vaccination were not reported; lot number R009163 has been verified to be a valid lot number, expiration date was reported and validated as 06-JAN-2020). No adverse effects were reported for the patients.  According to the reporter, the temperature excursion was below36 degrees Fahrenheit  (34.6 degrees Fahrenheit) for a time frame of 45 minutes, on an unspecified dates after February 2019 (product storage error), with previous temperature excursion reported above 47 degrees Fahrenheit  (61.1 degrees Fahrenheit) for a time frame of 1 hour; which was detected by a digital data logger.  This is a non-valid case due to lack of patient identifiers.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Pain in extremity, Paraesthesia
Clinical narrative: Painful tingling bilateral hands and feet x3 days. Better date of visit 3rd HPV. Associated symptoms include no numbness - Treatments tried none. Contact clinic if no improvement
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: CLIENT PRESENTED TO CLINIC ON 12/02/19 REQUESTING FOLLOW-UP FOR LT ARM PAIN REDUCED RANGE OF MOTION SUBSEQUENT TO FLU VACCINE RECEIVED AT CLINIC ON 11/04/19.  CLIENT REQUESTED EVALUATION BY A PHYSICIAN.  WRITER WAS ABLE TO REFER CLIENT TO COMMUNITY BASED CLINIC FOR EVALUATION ON 12/04/19.  TC TO CLIENT BY WRITER ON 12/10/19: CLIENT REPORTS SHE WAS SEEN BY A PHYSICIAN, RECEIVED PAIN MEDICATION AND REPORTS MILD IMPROVEMENT IN PAIN.
Age: 18.0
Sex: M
Vaccine: FLUC4
Symptoms: Cough, Dyspnoea, Dysstasia, Loss of consciousness
Clinical narrative: After receiving the vaccine patient walked back to waiting area to sit with his father. Within 1 minute he was having trouble standing and was guided to the chair. Started to lose consciousness and father attempted to keep him awake via light slapping on face. Was having some difficulty breathing and was coughing. 911 was called and arrived within 3 minutes. Patient stabilized and fully regained consciousness. Did not leave with paramedics.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Patient had extreme pain in her entire arm and went to the Emergency Room 1:49 AM on 1/1/20; patient was given a shot of morphine per spouse to help with her pain, spouse said pharmacist giving shot probably hit a nerve.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Erythema, Hyperhidrosis, Lip swelling, Swollen tongue
Clinical narrative: Shortness of breath, diaphoresis, swelling of lips and tongue, redness of face, HR 140s, BP systolic 140s,
Age: 26.0
Sex: F
Vaccine: HPV9
Symptoms: Eye swelling, Headache
Clinical narrative: approx. 1 hour later severe headache and L eye swelling
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Angioedema, Dyspnoea, Enlarged uvula, Pharyngeal swelling, Swollen tongue
Clinical narrative: Had HBV vax on 12/30/19 about 3 pm. Says that night, throat and tongue swelled up. +SOB at first, now able to breathe. Now afebrile.  Hasn't taken any meds. Denies any new foods, changes in environment, or encounters with new animals/plants.   Assessment and Plan T78.3XXA Angioedema, initial encounter  (primary encounter diagnosis) Plan : ? PREDNISONE 20 MG TABLET - Take 2 Tabs by            mouth once daily for 5 days           ? DIPHENHYDRAMINE 25 MG TABLET - Take 1 Tab by            mouth every 6 (six) hours as needed for            allergies Likely etiology of throat/tongue/uvula/tonsillar swelling. Medication administration and possible side effects reviewed ED/return cautions reviewed.  Patient expressed understanding.
Age: 34.0
Sex: M
Vaccine: HEP
Symptoms: Tonsillar hypertrophy
Clinical narrative: Had HBV vax on 12/30/19 about 3 pm. Says that night, throat and tongue swelled up. +SOB at first, now able to breathe. Now afebrile.  Hasn't taken any meds. Denies any new foods, changes in environment, or encounters with new animals/plants.   Assessment and Plan T78.3XXA Angioedema, initial encounter  (primary encounter diagnosis) Plan : ? PREDNISONE 20 MG TABLET - Take 2 Tabs by            mouth once daily for 5 days           ? DIPHENHYDRAMINE 25 MG TABLET - Take 1 Tab by            mouth every 6 (six) hours as needed for            allergies Likely etiology of throat/tongue/uvula/tonsillar swelling. Medication administration and possible side effects reviewed ED/return cautions reviewed.  Patient expressed understanding.
Age: 90.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Headache, Loss of consciousness, Muscle spasms, Pain, Somnolence
Clinical narrative: Past out for 3 hrs, developed cramps, headache NEXT day aches, sleepiness.
Sex: U
Vaccine: VARZOS
Symptoms: Purpura
Clinical narrative: arms and legs affected with severe purpura; This case was reported by a consumer via call center representative and described the occurrence of purpura in a 84-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced purpura. On an unknown date, the outcome of the purpura was recovered/resolved.   It was unknown if the reporter considered the purpura to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient experienced severe purpura after receiving 2nd dose of Shingrix. The purpura was fully recovered but arms and legs affected with severe purpura for almost two months. No further information was provided.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Injected limb mobility decreased, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: PT WAS IN PHARMACY PICKING UP RX FOR HIS WIFE ON 12/31/2019 AND MENTIONED TO ME THAT EVER SINCE HIS FLU SHOT HE HAS BEEN EXPERIENCING STIFFNESS AND MILD PAIN IN LEFT ARM WITH LIMITED MOBILITY.  IT USUALLY RESOLVES BY EVENING BUT REOCCURS WHEN HE WAKES UP IN THE MORNING. PT SAW MD ON 01/02/2019 AND HAS RECEIVED A RX FOR PREDNISONE
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Back pain, Blood heavy metal normal, Decreased appetite, Fatigue, Hypoaesthesia
Clinical narrative: On 3/1/2019 - Patient had a Hep B vaccine on 2/25/19. She stated with previous hep b vaccine, she has had some arm pain, but with this vaccine, she is experiencing back pain, in some places worse than others. Patient is wanting to know if she can take something for relief. She has already tried OTC pain relief without much help. I tried to return her call, but it went right to voicemail. A letter was sent out for her to call the clinic on 3/5/2019. On 3/8/2019, the patient had an office visit with her provider. She stating that 2 days after she received the Hep B vaccine she has had a sharp pain on the left side of her spine in the middle of the back. The doctor noted it was not related to the Hep B vaccination, but rather the pain was musculo-skeletal, and not in any way consistent w/any side effect to the hepatitis vaccine that she was aware of or could find in the literature.  On 3/11/2019, the patient continued to have shoulder pain and now jaw pain, which ibuprofen helped alleviate symptoms, and the patient had also lost her appetite.  On 5/16/2019, the patient presented to the clinic with c/o bilateral tingling in her foot/ankle/shoulder/neck, numbness, reduced appetite and didn't feel well enough to eat and constant feeling tired. She stated at this office visit she recently had loss of motor function of bilateral lower extremities . The physical exam was benign.  A referral to neurology was done and labs were drawn.  on 7/3/2019 - The patient was seen in neurology -
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Malaise, Motor dysfunction, Musculoskeletal pain, Pain in jaw, Paraesthesia
Clinical narrative: On 3/1/2019 - Patient had a Hep B vaccine on 2/25/19. She stated with previous hep b vaccine, she has had some arm pain, but with this vaccine, she is experiencing back pain, in some places worse than others. Patient is wanting to know if she can take something for relief. She has already tried OTC pain relief without much help. I tried to return her call, but it went right to voicemail. A letter was sent out for her to call the clinic on 3/5/2019. On 3/8/2019, the patient had an office visit with her provider. She stating that 2 days after she received the Hep B vaccine she has had a sharp pain on the left side of her spine in the middle of the back. The doctor noted it was not related to the Hep B vaccination, but rather the pain was musculo-skeletal, and not in any way consistent w/any side effect to the hepatitis vaccine that she was aware of or could find in the literature.  On 3/11/2019, the patient continued to have shoulder pain and now jaw pain, which ibuprofen helped alleviate symptoms, and the patient had also lost her appetite.  On 5/16/2019, the patient presented to the clinic with c/o bilateral tingling in her foot/ankle/shoulder/neck, numbness, reduced appetite and didn't feel well enough to eat and constant feeling tired. She stated at this office visit she recently had loss of motor function of bilateral lower extremities . The physical exam was benign.  A referral to neurology was done and labs were drawn.  on 7/3/2019 - The patient was seen in neurology -
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Spinal pain
Clinical narrative: On 3/1/2019 - Patient had a Hep B vaccine on 2/25/19. She stated with previous hep b vaccine, she has had some arm pain, but with this vaccine, she is experiencing back pain, in some places worse than others. Patient is wanting to know if she can take something for relief. She has already tried OTC pain relief without much help. I tried to return her call, but it went right to voicemail. A letter was sent out for her to call the clinic on 3/5/2019. On 3/8/2019, the patient had an office visit with her provider. She stating that 2 days after she received the Hep B vaccine she has had a sharp pain on the left side of her spine in the middle of the back. The doctor noted it was not related to the Hep B vaccination, but rather the pain was musculo-skeletal, and not in any way consistent w/any side effect to the hepatitis vaccine that she was aware of or could find in the literature.  On 3/11/2019, the patient continued to have shoulder pain and now jaw pain, which ibuprofen helped alleviate symptoms, and the patient had also lost her appetite.  On 5/16/2019, the patient presented to the clinic with c/o bilateral tingling in her foot/ankle/shoulder/neck, numbness, reduced appetite and didn't feel well enough to eat and constant feeling tired. She stated at this office visit she recently had loss of motor function of bilateral lower extremities . The physical exam was benign.  A referral to neurology was done and labs were drawn.  on 7/3/2019 - The patient was seen in neurology -
Age: 25.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Feeling abnormal, Presyncope, Seizure, Syncope
Clinical narrative: syncope/seizure/vagal collapse after the two shots.  He got the Havrix first and felt bad but didn't say anything.  Then the MMR pushed him over the edge.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site streaking, Injection site warmth
Clinical narrative: RIGHT upper extremity with an area of erythema measuring ~3"x 4" on the lateralwith an extension a streak of erythema extending up to axilla . The area is warm to touch and has tenderness to palpation. NO pustules, purulent drainage, fluctuance. cephalexin (KEFLEX) 500 mg capsule; Take 1 capsule (500 mg total) by mouth 4 (four) times a day for 7 days. Please take the antibiotics (CEPHALEXIN) as directed. Elevate the arm frequently and minimize use. Keep the area of infection clean and dry. You can take a shower or bath, but be sure to pat the area dry with a towel afterward. Do not put any antibiotic ointments or creams on the area.
Age: 12.0
Sex: M
Vaccine: FLU4, HPV9
Symptoms: Drooling, Hypoaesthesia
Clinical narrative: Patient complained of right arm numbness, right sided facial numbness and drooling about 6 hours after the vaccine was given.  Was taken to the ER where they diagnosed him with a possible seizure.  He had not had a seizure since age 4 and is not on anticonvulsants.  He had had a set of vitals taken at the clinic before the vaccines which were all normal.  His symptoms had resolved at the time of the ER discharge.  The mother listed on page 1 has more details about the ER visit as that was not in our healthcare system.
Age: 38.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: Patient with 2 weeks of left shoulder pain with pinpoint palpation and  movement
Age: 54.0
Sex: F
Vaccine: TDAP
Symptoms: Discomfort, Injection site pain, Neuralgia
Clinical narrative: History: Influenza vaccine RUE 10/30/2019. The patient also complained of burning over the lateral aspect of her right proximal arm extending up to the shoulder in the area where she had a flu shot. She states that this started up 1 or 2 days after her flu shot and continues to be a problem nowat 6/10 in severity and burning in nature.   Activity does not seem to make it worse she denies any recent fevers or chills there's no evidence of any drainage or acute infection within the skin or the site of her injection.   Exam right proximal arm laterally over the should and the deltoid.    Palpation elicits no fluctuance or induration there is no redness or deformity no evidence of infection whatsoever although she notes tenderness to palpation  Assessment: Right upper extremity localized  neuropathic pain reaction to influenza vaccine  Pan:  At this point patient is able to tolerate the discomfort and I doubt additional medication would be particularly useful.   If symptoms worse she is to report back to me.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect route of product administration, No adverse event, Product storage error
Clinical narrative: Patient did not experience any symptoms; a patient was administered a dose of improperly stored VARIVAX that was reconstituted with Merck DILUENT that did not experience a temperature excursion.; Nurse reports route of administration to be "intramuscular" rather than subcutaneous; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were unknown. The patient's concomitant therapy included sterile diluent. On 14-AUG-2019, the patient was vaccinated with a dose of improperly stored varicella virus vaccine live (oka/merck)(VARIVAX) of lot # R002057 with expiry date 22-JAN-2022 via intramuscular route rather than subcutaneous (frequency unspecified) for prophylaxis (incorrect route of product administration and product storage error). The sterile diluent used to reconstitute the vaccine was properly stored. It was reported that the vaccine was exposed to 15-46 degree Fahrenheit (18.3 F) temperature for 1 hour 15 minutes. Previous temperature excursion was at 15-46 degree Fahrenheit (34.5 F) temperature for 2 hours and 33 minutes. Digital data logger was involved. The patient did not experienced any symptoms (no adverse event).
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: Patient did not experince any symptoms; administered a dose of improperly stored VARIVAX; administration to be intramuscular rather than subcutaeous; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent condition and drug allergies/reactions were not reported.    On 17-JUL-2019, the patient was vaccinated with an improperly stored dose (product storage error) of varicella virus vaccine live (oka/merck) (VARIVAX) (strength, dose, schedule were not provided) (lot # R002057, expiry date: 22-JAN-2022) via intramuscular route (incorrect route of product administration) for prophylaxis. The vaccine was reconstituted with properly stored sterile diluent (reported as "did not experience a temperature excursion"). The vaccine underwent a temperature excursion of 15 degree Fahrenheit to 46 degree Fahrenheit (18.3 Fahrenheit) for a duration of 1 hour 15 minutes. The vaccine previously underwent a temperature excursion of 15 degree Fahrenheit to 46 degree Fahrenheit (34.5 Fahrenheit) for a duration of 2 hours 33 minutes. There was involvement of data logger. The nurse reported that, the patient did not experience any symptoms (no adverse event). There was no associated product quality complaint.
Age: 1.42
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left thigh has red, raised lump that is warm to touch and tender to touch near the injection site. Advised to use Benadryl, motrin and tylenol as needed. Call office if not resolved or gets worse.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Diarrhoea, Fatigue, Headache, Injection site pain, Injection site swelling
Clinical narrative: Sore arm and swelling at injection site, headache, fatigue,  diarrhea
Age: 64.0
Sex: M
Vaccine: HEPA
Symptoms: Asthenia, Back pain, Chest X-ray, Computerised tomogram, Dysphagia
Clinical narrative: high blood pressure, shooting extreme pain in toes feet and hands, trouble swallowing ,weakness,  back pain
Age: 64.0
Sex: M
Vaccine: HEPA
Symptoms: Hypertension, Magnetic resonance imaging, Pain, Pain in extremity
Clinical narrative: high blood pressure, shooting extreme pain in toes feet and hands, trouble swallowing ,weakness,  back pain
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Weakness Fever Nausea Shivers Soreness, swelling and warm to the touch at injection site
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Nausea, Pyrexia
Clinical narrative: Weakness Fever Nausea Shivers Soreness, swelling and warm to the touch at injection site
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Pain
Clinical narrative: Severe flu like symptoms, pain just below injection site.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Back pain, Gait disturbance, Groin pain, Joint noise
Clinical narrative: The day after receiving the vaccination I experienced sharp lower back on my left side. Over the next several days the pain continued to move to my left hip then across my leg to the groin. As the days passed, it traveled to the outside of my knee and then under it.  On Dec 12, as I stepped up I felt something in the outside of my left knee pop and I was having difficulty walking. After a week it move to the inside of my left knee where it is still present. An addition pain is present in my left shin. As it continued to move down my left side I kept hoping it would disappear. With Christmas and New Years  during this period, I decide to try to treat it myself with rest, icing, compression and elevation. I also did I also did some stretching exercises. I think I have done all that I can by myself. I called vaccination hotline on Jan 2 and followed this up with a call to my doctor who is seeing me tomorrow, Jan 3, 2020.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: The day after receiving the vaccination I experienced sharp lower back on my left side. Over the next several days the pain continued to move to my left hip then across my leg to the groin. As the days passed, it traveled to the outside of my knee and then under it.  On Dec 12, as I stepped up I felt something in the outside of my left knee pop and I was having difficulty walking. After a week it move to the inside of my left knee where it is still present. An addition pain is present in my left shin. As it continued to move down my left side I kept hoping it would disappear. With Christmas and New Years  during this period, I decide to try to treat it myself with rest, icing, compression and elevation. I also did I also did some stretching exercises. I think I have done all that I can by myself. I called vaccination hotline on Jan 2 and followed this up with a call to my doctor who is seeing me tomorrow, Jan 3, 2020.
Age: 16.0
Sex: F
Vaccine: MENB
Symptoms: Injection site erythema
Clinical narrative: Red area 3 inches in diameter after injection and continues now after she showers.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: REDNESS FROM NECK TO BELLY, WARM TO TOUCH THAT WAS SELF LIMITING AND LASTED ROUGHLY 24 HOURS
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain, Appendicectomy, Henoch-Schonlein purpura, Rash, Vomiting
Clinical narrative: Patient developed abdominal pain a few days after vaccination, then subsequently had an appendectomy.  A few days post-op he developed vomiting and rash, he was admitted to the hospital and then transferred to hospital where he was diagnosed with HSP.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia
Clinical narrative: Severe shivers, severe body aches, severe fatigue, fever
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Headache, Injection site erythema, Injection site inflammation, Injection site pain, Injection site warmth
Clinical narrative: Vaccine given 12.31.19 Symptoms started 1.1.20 - hot and tender area on back of left arm (where vaccine was administered) Today 1.2.20 - symptoms have worsened. Arm has two red inflammed and hot circles around the injection site, fever, malaise, headache.
Age: 20.0
Sex: F
Vaccine: UNK
Symptoms: Malaise, Pyrexia
Clinical narrative: Vaccine given 12.31.19 Symptoms started 1.1.20 - hot and tender area on back of left arm (where vaccine was administered) Today 1.2.20 - symptoms have worsened. Arm has two red inflammed and hot circles around the injection site, fever, malaise, headache.
Age: 11.0
Sex: M
Vaccine: FLUN4, HPV9, MNQ, TDAP
Symptoms: Dizziness, Eye movement disorder, Loss of consciousness, Syncope, Unresponsive to stimuli
Clinical narrative: Patient experienced syncope within 2 minutes of completing vaccination (vaccine order: FluMist, TDaP, MCV4, HPV9). Eyes rolled back in his head and he became unresponsive to vocal stimuli. Nurse supported his head and torso in the chair. He regained consciousness within one minute. After regaining consciousness, he was assisted to a mat on the floor, had his legs raised to a chair, and given juice. Patient reported continued dizziness for about 5 minutes after regaining consciousness, but denied nausea. After laying down for about 10 minutes, he denied dizziness and was helped to sitting, where he stayed about one minute. After being assisted to standing he denied dizziness, lightheadedness, nausea, or visual changes, upon which he left the clinic.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Injection site erythema, Injection site rash
Clinical narrative: Redness/Rash (4 inches by 2 inches) around injection site, headache, slight fever, general tiredness and feeling weak. These still existed at the time this report was filed (3 days). Took over the counter pain reliever (Advil) to address some of the issues being experienced.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Redness/Rash (4 inches by 2 inches) around injection site, headache, slight fever, general tiredness and feeling weak. These still existed at the time this report was filed (3 days). Took over the counter pain reliever (Advil) to address some of the issues being experienced.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Inflammation, Injected limb mobility decreased, Loss of consciousness, Malaise
Clinical narrative: 12/21/19 Patient said 2nd dose made her ill. She didn't have any issues with the first shot.  She got the shot on a Thursday and went to the ER that night. She said she was vomiting, feverish, and trembling. She said she couldn't move her arm and couldn't get out of bed. ER had put a cold pack on the arm she got a shot in  and they told her that their wasn't much they could do for her that the shot will make some people feel that way. I told her also about the side effects the day of the shot and that she needs to take Tylenol or Motrin every 4-6 hours for the inflammation and that she would feel better in a couple of days and ice the arm again  12/26/19 called to check on patient and she said she was slowly getting better. she said the muscle before the elbow is what hurts the most. she said she can lift her arm a little this morning but pain still shoots up and down her arm. she said she had to use a walker to get around Friday and Saturday.  she told me she took some medication after her shot to make her feel better on an empty stomach. she said that may be why she vomited.  she said she lost mobility  at home after the shot meaning she got dizzy and passed out when she got up to go to the bathroom. i told her to keep massaging her arm and using the ice packs.  01/01/2020 Follow up phone call with patient. She says she is able to use the arm,  but it is still painful. She is rotating ice and heat as directed (heat helps more).
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia, Tremor, Vomiting, Walking aid user
Clinical narrative: 12/21/19 Patient said 2nd dose made her ill. She didn't have any issues with the first shot.  She got the shot on a Thursday and went to the ER that night. She said she was vomiting, feverish, and trembling. She said she couldn't move her arm and couldn't get out of bed. ER had put a cold pack on the arm she got a shot in  and they told her that their wasn't much they could do for her that the shot will make some people feel that way. I told her also about the side effects the day of the shot and that she needs to take Tylenol or Motrin every 4-6 hours for the inflammation and that she would feel better in a couple of days and ice the arm again  12/26/19 called to check on patient and she said she was slowly getting better. she said the muscle before the elbow is what hurts the most. she said she can lift her arm a little this morning but pain still shoots up and down her arm. she said she had to use a walker to get around Friday and Saturday.  she told me she took some medication after her shot to make her feel better on an empty stomach. she said that may be why she vomited.  she said she lost mobility  at home after the shot meaning she got dizzy and passed out when she got up to go to the bathroom. i told her to keep massaging her arm and using the ice packs.  01/01/2020 Follow up phone call with patient. She says she is able to use the arm,  but it is still painful. She is rotating ice and heat as directed (heat helps more).
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia, Pruritus, Rash, Skin discolouration
Clinical narrative: After the vaccine, Dec 6th (within 24 hrs),  there was sever itching on skin surface.  After a few days the itching turned to a rash condition.  Not specific on exact timing for initial rash.    The Rash developed into open sores with deep nerve pain.    Went back to the doctor on Dec 17th and was diagnosed that this was shingles.  The rash in close proximity to left arm, where shot was given.  it extended from middle of back, under arm pit and on left side of chest.
Age: 58.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin ulcer
Clinical narrative: After the vaccine, Dec 6th (within 24 hrs),  there was sever itching on skin surface.  After a few days the itching turned to a rash condition.  Not specific on exact timing for initial rash.    The Rash developed into open sores with deep nerve pain.    Went back to the doctor on Dec 17th and was diagnosed that this was shingles.  The rash in close proximity to left arm, where shot was given.  it extended from middle of back, under arm pit and on left side of chest.
Age: 67.0
Sex: F
Vaccine: FLU3, PPV, VARZOS
Symptoms: Arthralgia, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: Patient came back to pharmacy 5 days later and said that she still had swelling in her entire right arm down through her hand. Stated that her arm and elbow were sore and the arm was hot to touch.  She said that the swelling started after the vaccine and got worse but was starting to improve but she was concerned since it was day 5.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Magnetic resonance imaging joint, Magnetic resonance imaging normal, Mobility decreased, Musculoskeletal pain
Clinical narrative: Shoulder pain and inability to move shoulder within 2 hours of receiving vaccine. Decreased range of motion, still having pain at 2 month mark. MRI of joint done approx. 1 month after vaccination and MRI was clear. No other advice from physician assistant other than to wait it out for 6 months.
Age: 73.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Loss of consciousness
Clinical narrative: Patient wife received call from me stating that they were both due for their follow up vaccines in the shingrix series. She stated that her husband should have never received both the shingles and flu shot and that due to receiving both on the same day he then the next day passed out and was hospitalized.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Electromyogram normal, Hypoaesthesia, Injected limb mobility decreased, Winged scapula
Clinical narrative: Two weeks after the flu shot given to my son's right arm he told me that he felt his arm sleepy and he couldn't life his arm on it's own.  I thought is was a muscle tension so tried heating pad and massage the area. When I didn't see any improvement in 2 days I made an appointment  with a hand and upper extremity specialist and also neurologustbecause the area affected was his brachial plexus of his C5 and C6 with the supraspinatus and infradpinstus muscles where affected. Currently on occupational therapist and had a EMG done to check his nerve signals.
Age: 51.0
Sex: M
Vaccine: UNK
Symptoms: Injection site pain, Tendonitis, X-ray normal
Clinical narrative: Flu vaccination injected into ver upper deltoid at shoulder joint. Within days acute intense and lasting pain developed. Seen at both urgent care and Emergency room and initially dignosed as tendinitis caused by vaccination placement.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Hyperhidrosis, Injection site pain, Musculoskeletal pain, Nausea
Clinical narrative: Nausea, sweating, headache for two day. Severe and persistent shoulder pain to the present day. Currently seeking medical treatment for adverse side effects.  The shot was given at the shoulder. Pain radiates from the injection site deep into the muscle.
Age: 28.0
Sex: M
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Nausea, sweating, headache for two day. Severe and persistent shoulder pain to the present day. Currently seeking medical treatment for adverse side effects.  The shot was given at the shoulder. Pain radiates from the injection site deep into the muscle.
Age: 66.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Influenza like illness, Nausea
Clinical narrative: chills, nausea, flu-like symptoms after first Shingrix vac. in May 2019; second vac.(12/19) reaction worse than first. Symptoms more acute. My concern: can the vaccine be reformulated to eliminate such extreme reactions. The reactions were listed in the information I received from the pharmacist, however, it is not acceptable to subject people to these adverse reactions. "It's better than getting shingles," is not an illuminating response.
Age: 1.25
Sex: F
Vaccine: FLU4
Symptoms: Rash
Clinical narrative: Patient broke out into a rash after receiving vaccine. Rash appears to be resolved within 10 minutes.
Age: 30.0
Sex: M
Vaccine: FLUC4
Symptoms: Nerve injury
Clinical narrative: Patient came in on December 14, 2019 complaining of nerve damage that started after receiving his flu vaccination on November 27, 2019. Patient was seen by physician where he was told that the nerve damage seemed to be localized.