chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: UNK
Symptoms: Dyspnoea, Hepatic cancer metastatic, Hepatic cancer stage IV, Hypersensitivity, Throat tightness
Clinical narrative: metastasis/metastasized to her liver, stage 4; allergic reaction; hard of hearing; trouble breathing; throat closed; hives; This is a spontaneous report from a contactable consumer. A 72-year-old female patient received second dose of pneumococcal 13-val conj vac (dipht crm197 protein) via an unspecified route of administration on an unspecified date at single dose for immunisation. Medical history included breast cancer from 1999, double mastectomy. Historical Vaccine included first dose of Pneumococcal 13-Val Conj Vac received on an unspecified date for immunisation. The patient's concomitant medications were not reported. The patient will be starting palbociclib (IBRANCE) for breast cancer that has metastasized to her liver, stage 4. She first had it in 1999; had double mastectomy 15 years later and now, 5 years later, there is metastasis. She stated that she had an allergic reaction after her "second pneumonia shot/vaccine" (name and manufacturer of product unknown) but was told that the second one was different from the first pneumonia shot (the second one had a few more different ingredients from first one). She stated that within 15 minutes of getting the second shot, her throat closed and she had trouble breathing. She took diphenhydramine (she can't take regular Benadryl due to food coloring), put ice on her throat, and chewed on ice chips and the reaction subsided within 15 minutes. She also reported she did have an underlying issue with hives, that she could get hives randomly. She was also hard of hearing. The outcome of events was unknown.  Information on the batch number has been requested.
Sex: M
Vaccine: MENB
Symptoms: Gait disturbance, Mobility decreased, Myalgia
Clinical narrative: Trouble walking; Trouble moving arm; Muscle soreness; This is a spontaneous report from a contactable other health care professional (hcp). This other hcp reported similar events for 3 patients. This is the second of 3 reports. A 16-year-old male patient received meningococcal group b rlp2086 (TRUMENBA, lot CN1583, expiry date Aug2022, NDC number: 0005010005), via an unspecified route of administration on 24Aug2020 (reported as yesterday) at 0.5 mL, single (1 injection, dose given twice 6 months apart) for vaccination. There were no medical history and concomitant medications. Reporter stated that they give the vaccine either in the arm or in the thigh if a patient has small arms. On Aug2020, the patient had muscle soreness and had trouble moving arm or trouble walking if given in the thigh (pending clarification). The outcome of events muscle soreness, had trouble moving arm and trouble walking was unknown.   No follow up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020330359 Same reporter/drug/event for different patients;US-PFIZER INC-2020330595 Same reporter/drug/event for different patients
Sex: F
Vaccine: MENB
Symptoms: Gait disturbance, Mobility decreased, Myalgia
Clinical narrative: muscle soreness; trouble moving arm; Trouble walking; This is a spontaneous report from a contactable other health care professional (hcp). This other hcp reported similar events for 3 patients. This is the first of three reports.   A 16-year-old female patient received meningococcal group b rlp2086 (TRUMENBA, Suspension for injection, lot number CN1583, expiry date Aug2022, NDC number 0005010005), via an unspecified route of administration, on 17Aug2020 at 0.5 mL, single (also reported as 1 injection dose given twice at 6 months apart), for vaccination. The patient has no medical history. There were no concomitant medications. The other hcp stated that they give the vaccine either in the arm or in the thigh if a patient has small arms. On Aug2020, the patient had muscle soreness and had trouble moving arm or trouble walking if given in the thigh (pending clarification). The outcome of the events was unknown.  No follow-up attempts are needed. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020330145 same reporter/drug/events, and different patient;US-PFIZER INC-2020330595 same reporter/drug/events, and different patient
Sex: M
Vaccine: MENB
Symptoms: Gait disturbance, Mobility decreased, Myalgia
Clinical narrative: Muscle soreness; Trouble moving arm; Trouble walking; This is a spontaneous report from a contactable other health care professional (hcp). This other hcp reported similar events for 3 patients. This is the third of 3 reports.  A 16-years-old male patient received meningococcal group b rlp2086 (TRUMENBA, lot CN1583, expiry date Aug2022, NDC number: 0005010005), via an unspecified route of administration in Aug2020 at 0.5 mL, single (1 injection, dose given twice 6 months apart) for vaccination. There were no medical history and concomitant medications. Reporter stated that they give the vaccine either in the arm or in the thigh if a patient has small arms. On an unspecified date in Aug2020, the patient had muscle soreness and had trouble moving arm or trouble walking if given in the thigh (pending clarification). The outcome of events muscle soreness, had trouble moving arm and trouble walking was unknown.   No follow up attempts are needed. No further information expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-2020330145 Same reporter/drug/event for different patients;US-PFIZER INC-2020330359 Same reporter/drug/event for different patients
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Chills, Dizziness, Fatigue, Headache
Clinical narrative: painful right  deltoid, painful right armpit, neck pain, headache, extreme fatigue, shivering/chills, swollen lymph nodes neck right side behind clavicle, dizziness
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Lymphadenopathy, Neck pain
Clinical narrative: painful right  deltoid, painful right armpit, neck pain, headache, extreme fatigue, shivering/chills, swollen lymph nodes neck right side behind clavicle, dizziness
Age: 11.0
Sex: F
Vaccine: HEPA, IPV, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Parent called stating she noted Pt's Right arm with redness at both injection sites along with pain a day after receiving vaccines. Parent stated she applied cool compresses as instructed by this Nurse for relief of discomfort. Parent stated the redness has improved on today when she called in. Stated pain is also improving. Pt no longer complaining as often like day before. Parent state Pt is not disoriented or confused and is otherwise normal.  Advised Parent to continue to apply cool compress and to also administer a pain reliever to help with discomfort and seek medical assistance if Pt worsens or if she feels Pt needs to be examined. Parent verbalized understanding stating she will continue to monitor and administer pain reliever and cool compress as needed.
Age: 11.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Alanine aminotransferase increased, Aspartate aminotransferase increased, Blood creatinine increased, Blood urea increased, Diarrhoea
Clinical narrative: on day of 8/25 felt fatigued in the afternoon, over the next two days had one or two emesis and one diarrhea.  There was one fever reported on 8/26.  on 8/27 patient was found to be hypotensive and in septic shock.  Currently as of today is on epinephrine infusion for hypotension.
Age: 11.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Disseminated intravascular coagulation, Fatigue, Full blood count, Haemolysis, Hypotension
Clinical narrative: on day of 8/25 felt fatigued in the afternoon, over the next two days had one or two emesis and one diarrhea.  There was one fever reported on 8/26.  on 8/27 patient was found to be hypotensive and in septic shock.  Currently as of today is on epinephrine infusion for hypotension.
Age: 11.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Pyrexia, Septic shock, Thrombocytopenia, Urine analysis abnormal, Vomiting
Clinical narrative: on day of 8/25 felt fatigued in the afternoon, over the next two days had one or two emesis and one diarrhea.  There was one fever reported on 8/26.  on 8/27 patient was found to be hypotensive and in septic shock.  Currently as of today is on epinephrine infusion for hypotension.
Age: 11.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: White blood cell count decreased
Clinical narrative: on day of 8/25 felt fatigued in the afternoon, over the next two days had one or two emesis and one diarrhea.  There was one fever reported on 8/26.  on 8/27 patient was found to be hypotensive and in septic shock.  Currently as of today is on epinephrine infusion for hypotension.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site pain, Injection site pruritus, Injection site swelling, Pyrexia, Rash
Clinical narrative: Hives all over body, Swelling at injection site, itching, soreness, low fever (100.8). fever started 8/27/20. rash started 8/26/20. has been given Benadryl and Ibuprofen as directed.
Age: 6.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria
Clinical narrative: Hives all over body, Swelling at injection site, itching, soreness, low fever (100.8). fever started 8/27/20. rash started 8/26/20. has been given Benadryl and Ibuprofen as directed.
Age: 1.0
Sex: F
Vaccine: HEP, IPV
Symptoms: No adverse event, Product storage error
Clinical narrative: The vaccine refrigerator went out which caused a temperature excursion affecting the MMR and IPV vaccines. No adverse effects were reported due to this.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Hyperhidrosis, Hyperventilation, Injection site pain, Injection site swelling
Clinical narrative: Woke up at 1 am with legs cramping then I went to the bathroom and felt like passing out. I stood up and passed out landing on my back. I was sweating profusely and hyper ventilating. I crawled to bed where I continued to have convulsions through out my body for the next hour. The injection sight was swollen and hurt extremely bad. 10 times worse than the flu shot.  These symptoms have gone away and the soreness is slowly getting better.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Loss of consciousness, Muscle spasms, Seizure
Clinical narrative: Woke up at 1 am with legs cramping then I went to the bathroom and felt like passing out. I stood up and passed out landing on my back. I was sweating profusely and hyper ventilating. I crawled to bed where I continued to have convulsions through out my body for the next hour. The injection sight was swollen and hurt extremely bad. 10 times worse than the flu shot.  These symptoms have gone away and the soreness is slowly getting better.
Age: 16.0
Sex: M
Vaccine: HEPA, MEN, TDAP, VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: No side effects or adverse reactions reported; expired VARIVAX given to a patient today, 7/31/2020; This spontaneous report was received from a medical assistant regarding a 16 years old male patient. Concomitant medications included hepatitis A virus vaccine (unspecified), meningococcal A and tetanus (+) diphtheria (+) pertussis (Tdap). The patient's pertinent medical history and drug reactions/allergies were not reported.  On 31-JUL-2020, an expired dose of varicella virus vaccine live (Oka/Merck) (VARIVAX) 0.5 ml (lot R020673 and expiration date: 18-JUL-2020; strength, frequency, anatomical location were not reported) was given to the patient subcutaneously in right arm for prophylaxis (updating immunizations for school) (expired vaccine used). The patient didn't seek medical attention. No treatment was received. No side effects or adverse reactions reported.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This initial spontaneous report was received on from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history and concomitant medication were not provided.   On an unspecified date in 2010, the patient was vaccinated with a dose zoster vaccine live (ZOSTAVAX) (dosage regimen was not reported) for the long-term prevention of shingles and/or zoster-related conditions.   On an unspecified date, subsequent to patient's dose zoster vaccine live (ZOSTAVAX) inoculation, the patient presented shingles. As a direct and proximate result, the patient had and would continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and would continue to suffer such losses, and damages in the future.  The reporter considered the event of shingles to be related to zoster vaccine live (ZOSTAVAX).
Age: 56.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pneumococcal Polysaccharide PPV 23 (9/1/2007); Pneumococcal Conjugate PCV (9/9/2016); This spontaneous report was received from a physician referring to a 66-years old male patient (pt). No information regarding current condition, historical condition or concomitant medication was reported.  On 01-SEP-2007, the pt was vaccinated with pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (strength, dose, route, batch/lot# and expiration date were unknown) in a drug store for prophylaxis. On 09-SEP-2016, the pt was vaccinated with dose of pneumococcal 13v conj vaccine (crm197) (0.5 mL, lot# m98915, expiration date was reported as 01-SEP-2017) intramuscularly in the left arm for prophylaxis. On 15-SEP-2017, the pt was vaccinated with another dose of pneumococcal vaccine, polyvalent (23-valent) (manufacturer unknown) (reported as pneumococcal) (strength, dose, route, batch/lot# and expiration date were unknown) for prophylaxis (extra dose administered). No adverse reactions or side effects was provided following these vaccinations. The outcome of extra dose administered was unknown.  This case was split from a case in litigation. (Link# 1812USA002774)  Sender's Comments: US-009507513-1812USA002774:
Age: 17.0
Sex: F
Vaccine: HEPA, MNQ, VARCEL
Symptoms: Erythema, Induration, Oedema, Skin reaction
Clinical narrative: Skin reaction ~5cm of induration/erythema and edema
Age: 61.0
Sex: M
Vaccine: HEPA, PPV, VARZOS
Symptoms: Joint range of motion decreased, Limb discomfort, Pain in extremity
Clinical narrative: Patient presented to this pharmacist at time of pick of his oral medications expressing the discomfort and pain, in his right arm, he still had from his vaccine a month ago. He expressed that he had reduced range of motion and continued pain. This pharmacist encouraged the patient to seek medical attention as soon as possible and assured the patient I would be reporting the event to VAERS as well.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Severe headache, muscle ache, fever, shivering, acute fatigue, sweating
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Severe headache, muscle ache, fever, shivering, acute fatigue, sweating
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Arms very firm, red, and hot to touch. One arm?s firmness spread about three inches in length and five or six inches of redness. Other ask was only about an inch of firmness and inch and a half of redness.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Patient had severe swelling and redness in arm of injection. She had to go to the emergency room 6 days after admin and received an antibiotic. MD said she had cellulitis.
Age: 78.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Pain in extremity, Skin warm
Clinical narrative: The patient reported soreness in the right arm and it was warm.  She also said it was itchy.  It has diminished since the shot was given until she called today.
Age: 84.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient has a 1 out of 10 on the pain scale on the arm that comes and goes
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pyrexia
Clinical narrative: Fever 101, chills  fatigue
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Cyanosis, Developmental delay, Electroencephalogram abnormal, Generalised tonic-clonic seizure, Irritability
Clinical narrative: Minimum of two absence seizures three days after the vaccinations in morning/early afternoon followed by a tonic-clonic seizure in the afternoon at home and two more in the ER.  Lips turned blue in ER.  Initial Ativan dose in ER did not stop seizures, so they gave her Keppra as well.  She was admitted and had several more  seizures, roughly every 75 minutes according to when her O2 stats dropped while she was sedated.   The seizures lasted less than 30 seconds initially and were over 2 minutes later.  After a day or so on two medications,  she was  irritable, twitchy, and clawing/climbing all over me and wasn't sleeping well, so they took her off one medication and was left on Keppra.  After being discharged and adjusting her dosage she remained  seizure free on Keppra  2x/day for over two years until we tapered her off in the fall of 2017.   She has been seizure free since late January 2015 on meds and since the fall 2017 off the meds.  Whether related or not, she had a delay in walking (did not walk full time until almost 2 years old, has a speech delay, Selective Mutism, and suspected sensory issues (gait, sounds, textures).
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Magnetic resonance imaging normal, Muscle twitching, Oxygen saturation decreased, Petit mal epilepsy, Poor quality sleep
Clinical narrative: Minimum of two absence seizures three days after the vaccinations in morning/early afternoon followed by a tonic-clonic seizure in the afternoon at home and two more in the ER.  Lips turned blue in ER.  Initial Ativan dose in ER did not stop seizures, so they gave her Keppra as well.  She was admitted and had several more  seizures, roughly every 75 minutes according to when her O2 stats dropped while she was sedated.   The seizures lasted less than 30 seconds initially and were over 2 minutes later.  After a day or so on two medications,  she was  irritable, twitchy, and clawing/climbing all over me and wasn't sleeping well, so they took her off one medication and was left on Keppra.  After being discharged and adjusting her dosage she remained  seizure free on Keppra  2x/day for over two years until we tapered her off in the fall of 2017.   She has been seizure free since late January 2015 on meds and since the fall 2017 off the meds.  Whether related or not, she had a delay in walking (did not walk full time until almost 2 years old, has a speech delay, Selective Mutism, and suspected sensory issues (gait, sounds, textures).
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Psychomotor hyperactivity, Selective mutism, Sensory disturbance, Speech disorder developmental
Clinical narrative: Minimum of two absence seizures three days after the vaccinations in morning/early afternoon followed by a tonic-clonic seizure in the afternoon at home and two more in the ER.  Lips turned blue in ER.  Initial Ativan dose in ER did not stop seizures, so they gave her Keppra as well.  She was admitted and had several more  seizures, roughly every 75 minutes according to when her O2 stats dropped while she was sedated.   The seizures lasted less than 30 seconds initially and were over 2 minutes later.  After a day or so on two medications,  she was  irritable, twitchy, and clawing/climbing all over me and wasn't sleeping well, so they took her off one medication and was left on Keppra.  After being discharged and adjusting her dosage she remained  seizure free on Keppra  2x/day for over two years until we tapered her off in the fall of 2017.   She has been seizure free since late January 2015 on meds and since the fall 2017 off the meds.  Whether related or not, she had a delay in walking (did not walk full time until almost 2 years old, has a speech delay, Selective Mutism, and suspected sensory issues (gait, sounds, textures).
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: Tiredness, fever, soreness
Age: 16.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: erythema, swelling, warmth, itching
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying, Injection site discolouration, Injection site erythema, Injection site rash, Screaming
Clinical narrative: Approx 3 hours after infection patient woke from a nap screaming and crying. She was sleeping in her diaper and when her mother went to console her she noted a very well demarcated rash to the LE bilaterally. There was a well defined line to the upper thigh where the legs below were bright red and the heals were noted to be purplish in color.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Pyrexia
Clinical narrative: At the site of 2 injections (both done on right leg), a hard, red lump developed under the skin. It was red all round the injection site about the size of a quarter. Redness was starting to spread off of that quarter-sized spot.  Painful to touch. Had a fever of 100.4.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Extra dose administered
Clinical narrative: Computer glitch  didn't transmit vaccine given earlier , so patient was given a second dose one week later.
Age: 55.0
Sex: F
Vaccine: FLU4, TDAP, VARZOS
Symptoms: Erythema, Injection site vesicles, Peripheral swelling
Clinical narrative: Patient presented with redness and mile swelling covering half her arm on the outward aspect.  In the center of the arm where the TDaP vaccine was placed, patient also had small blisters around the injection site. Patient was directed to visit prescriber for evaluation.  Patient denied any other pain, itching, fever, or other symptoms.
Age: 21.0
Sex: F
Vaccine: HPV9, TDAP
Symptoms: Headache, Pyrexia, Tuberculin test negative
Clinical narrative: Client came to clinic on 8/27/20.  At that time, she reported that after receiving HPV9 and Tdap on 7/28/20, she had a low grade fever (less than 100 degrees F) and a headache every day for 4-5 days.  She also had a PPD placed the same day (route ID, in Left forearm).  She did not require an MD visit and the symptoms resolved without any further complications.  She denies any other symptoms.  No current complaints.  Feeling well.
Age: 65.0
Sex: F
Vaccine: FLUA4, PPV, TDAP, VARZOS
Symptoms: Hypotension, Nausea, Pain, Vomiting
Clinical narrative: patient reported severe nausea, vomitting and low blood pressure as was as debilitating pain
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache
Clinical narrative: Shivering - started 8pm on day of vaccination, lasted until about 3am Tired, headache - started the morning following the day of vaccination and lasted all day
Age: 0.17
Sex: M
Vaccine: DTAP, HEP, IPV, RV1
Symptoms: Haematochezia, Vomiting
Clinical narrative: Vomitting, blood in stool.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pain
Clinical narrative: Head ache, body aches, chills, nausea beginning in the early hours the following day.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Bursitis, Tendonitis
Clinical narrative: Left arm rotator cuff bursitis/tendinitis noted 2 days post vaccine
Age: 73.0
Sex: F
Vaccine: FLUA3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: sore arm/shoulder  past 5 days
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Headache, Myalgia, Pain in extremity, Peripheral swelling
Clinical narrative: muscle aches.chills.sore and swollen arm,headache
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Joint swelling, Rash erythematous
Clinical narrative: Patient stated that their arm formed a red rash a few hours after receiving the vaccination. It proceeded down his arm to just below his elbow over the next day. It also caused his elbow to swell to be almost double in size. The patient came in to report this event approximately 40 hours after receiving the vaccine and the rash and swelling were still visible. I advised patient to seek treatment with primary care physician or urgent care.
Age: 64.0
Sex: F
Vaccine: FLUA4
Symptoms: Chills, Myalgia
Clinical narrative: Severe, teeth chattering chills and incapacitating muscle aches   Never experienced before with a flu shot
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site extravasation
Clinical narrative: After routine administration of IM injection with 1 inch needle, patient had clear fluid leaking from injection site.  I was unable to determine if fluid was vaccine or interstitial fluid or the amount of fluid.
Age: 68.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Abdominal discomfort, Fatigue, Headache, Myalgia, Pain
Clinical narrative: Patient experienced frequent urination thoughout the night after receiving the vaccination. She also reports a fever of 100 degrees, body aches, muscle aches, fatigue, upset stomach and headaches starting early this morning and throughout the day. I referred the patient to her primary care provider for evaluation.
Age: 68.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pollakiuria, Pyrexia
Clinical narrative: Patient experienced frequent urination thoughout the night after receiving the vaccination. She also reports a fever of 100 degrees, body aches, muscle aches, fatigue, upset stomach and headaches starting early this morning and throughout the day. I referred the patient to her primary care provider for evaluation.
Age: 15.0
Sex: M
Vaccine: UNK
Symptoms: Haemoglobin decreased, Haemolytic anaemia, Jaundice, Pyrexia
Clinical narrative: Fever starting 2 hours after vaccination   Increased jaundice and hemolytic anemia in setting of patient with hereditary spherocytosis starting ~24 hours after vaccination
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity, Peripheral swelling
Clinical narrative: Patient experienced painful swelling and heating of left arm, described to be similar to a bee sting, lasting for a few days. Patient is allergic to bee stings, recalling the severity of the swelling/redness/heat at the site.
Age: 66.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Skin warm
Clinical narrative: Patient experienced painful swelling and heating of left arm, described to be similar to a bee sting, lasting for a few days. Patient is allergic to bee stings, recalling the severity of the swelling/redness/heat at the site.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Pain, Pruritus, Rash macular
Clinical narrative: Injection site red and swollen, red blotches down and under arm  Hurting and a bit itchy
Age: 56.0
Sex: M
Vaccine: FLUR4
Symptoms: Musculoskeletal pain
Clinical narrative: patient is saying he has left shoulder pain a year later after the flu shot.  We have documented that the flu shot was given in the right arm on the consent form.  We document immediately after administration.   Patient wants us to alter the consent form to say left arm as he mentioned it was on his tattoo arm.
Age: 84.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Inflammation, Peripheral swelling, Skin warm
Clinical narrative: Patient developed redness, hot to touch and inflammation (swollen) arm
Age: 93.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dizziness
Clinical narrative: Patient felt dizzy after maybe about 5-10minutes of receiving Fluzone HD, as pt was walking out of the store. He had to lay down on the floor as he was feeling weak.He was attended by an EMT, and was taken to hospital.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash erythematous
Clinical narrative: 48 hours after vaccination full-body red rash appeared over whole body
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Nausea, Pain, Urticaria
Clinical narrative: as per patient she broke out in hives, diarrhea, body aches, nausea - Hives starting first on 8/19 and slowly going away with Benadryl. Diarrhea, Nausea, Body aches continuing until 8/26/20- she called her Dr and was told to take Tylenol, and Immodium.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Diarrhoea, Pyrexia, Somnolence
Clinical narrative: Per patient's mother, at 7 AM on 8/25/2020, infant had "diarrhea" stool and fever of 101.9.  Was noted to be sleepy, but easily aroused.  Was nursing vigorously intermittently.  Had another "diarrhea" stool. Fever was treated with acetaminophen and tepid bath with temperature declining to 99 degrees.  At 11:40 AM on 8/25/2020, infant awakened and temperature measured 100.9 in left ear that was against bedding and right ear that was not against bedding temperature was 98.6 degrees.  No further "diarrhea" stool.  Infant had fully recovered the morning of 8/26/2020 with normal temperature and no abnormal stooling.  Continues to feed well and other wise doing well.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Discomfort, Pain, Peripheral swelling, Pyrexia
Clinical narrative: Pharmacist gave patient the vaccine in the left arm intramuscularly. Moments after the injection the patient felt a discomfort. Patient reported that there was swelling along the arm when she got home. Patient had a fever of 102. Patient took Tylenol 500mg three times a day to treat the fever and pain. Days after the pain still persists but the patient is able to return to work now.
Age: 85.0
Sex: F
Vaccine: PNC13
Symptoms: Chest pain, Dizziness, Dyspnoea, Feeling hot
Clinical narrative: Appx 30min after shot. Pt reported back to pharmacy with husband citing; overheated, dizziness, chest pain, breathlessness. I (pharmacist) provided a chair, helped pt take off sweater and surgical mask (covid mask). I also recommended she let me call her ambulance on account of age and symptoms. Her husband reported that the chest pain and breathlessness are "nothing new." I once again advised them to let me call them an ambulance. Being of sound mind and body and oriented X 3 the pt refused but assured me she was headed to the nearest urgent care. There was nothing on vaccine consent form that indicated reason to refuse vaccine and shot was indicated according to vaccine registry. Attempted to reach out to pt at 6:00 pm -- phone rang w/out answer and again at 8:00pm and I was sent to voice mail. Outcome is unknown at this time.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Skin warm
Clinical narrative: Warm, red rash lasting now 6 days and not subsiding
Age: 18.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Muscle twitching, Respiratory rate decreased
Clinical narrative: Patient was dizzy after injection, laid down and then breathig got slower. She was twitching for 30 seconds to 1 minute but it wast not a seizure. I called 911 right away and waited until paramedics came. Patient was wiht their parents who stated that she had not drank or ate anything all morning and vaccine was given at 11:30am. Never lose conscious but breathing was very slow.
Age: 83.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Heart rate increased, Pyrexia
Clinical narrative: Patient's wife states he had a fever beginning that night which broke around 2:30am. That evening his pulse went up to 218 bpm and his blood pressure was 190/125. His arm is still very red.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Malaise, Pain in extremity
Clinical narrative: Patient's wife stated that the patient felt very ill the night of getting the vaccine. His arm has been very red and sore. He is having to wear an ice bandage.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Injection site bruising, Injection site erythema, Injection site irritation, Injection site swelling, Irritability
Clinical narrative: Irritation and swelling at injection site, swelling of entire left arm, irritability and stopped using left arm for several hours due to pain and would not play. After giving motrin and icing the arm the pain eventually went away, but the arm remained swollen for a few weeks and the injection site was still red and bruised.
Age: 1.33
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Pain
Clinical narrative: Irritation and swelling at injection site, swelling of entire left arm, irritability and stopped using left arm for several hours due to pain and would not play. After giving motrin and icing the arm the pain eventually went away, but the arm remained swollen for a few weeks and the injection site was still red and bruised.
Age: 1.17
Sex: F
Vaccine: DTAP
Symptoms: Abnormal behaviour, Cyanosis, Fatigue, Hypotonia, Pallor
Clinical narrative: My husband was holding her. She was acting tired which isn't normal for her even was she is tired.  While holding her, her eyes were barely open and she was laying across his arms. He changed her diaper on the changing table a few minutes later. During the diaper change, she had her eyes closed and was not fighting the activity. Once again, this is not normal for her not to fight a diaper change. While she was laying on the table, i gave her 2.5mL of tylenol and 1.25mL of ibuprofen. She normally loves taking her medications but turn her head away. I placed the syringe in the side of cheek and slowly dispense the medications. My husband finished her diaper change and brought her to the kitchen where I was located. He was holding her across his body. When I looked at her, her skin was pale and lips was very pale. I grabbed her from my husband and carried her to the living room. She was limp, her lips were blue when i placed her on the floor and her eyes were closed. I unzipped her PJ and started stimulating her chest. During this time, I was telling her to breath and saying her name. Quickly, her lips were pale again, then a few moments later she opened her eyes. She laid on the floor for approximately 2 minutes before she got back up and started behaving normally with normal skin and lip color. The entire incident approximately started at 9:55am to 10:05am(I had texted a friend who is a nurse to call me asap at 10:09).
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Alopecia, Blood test abnormal, Eczema, Food allergy, Insomnia
Clinical narrative: Developed eczema 3 days after shot. Started mild and has turned in to severe eczema. Lost her hair. Stopped sleeping at night. Developed food allergies.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Skin test positive
Clinical narrative: Developed eczema 3 days after shot. Started mild and has turned in to severe eczema. Lost her hair. Stopped sleeping at night. Developed food allergies.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Rash
Clinical narrative: Right upper arm (injection site) soreness, swelling, redness, pain. Developed a rash on front of torso on 8/24/20
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Allergy to vaccine, Chest X-ray normal, Electrocardiogram normal, Heart rate increased, Pyrexia
Clinical narrative: I woke up the morning following the vaccination with a slight fever, a very loud beeping in both ears consistent with my pulse rate, and a pulse of 115 (normally it's 66). Around noon I went back to the pharmacy to ask whether an elevated heart rate was a known side effect. The pharmacist verified my HR and sent me home warning me to look out for symptoms of a stroke. I decided instead to go to Urgent Care where they verified my tachycardia, took an Xray to check my lungs (they were normal) and an EKG (also normal). They sent me home warning me to look out for symptoms of a stroke. I woke up the next morning with a normal heart rate and almost inaudible tinnitus  (normal for me). Three days after the tachycardia I was examined by a physician whose comment was "thank goodness this was your second vaccination, not your first." She then entered Shingrix in my medical record as an allergy.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Tachycardia, Tinnitus
Clinical narrative: I woke up the morning following the vaccination with a slight fever, a very loud beeping in both ears consistent with my pulse rate, and a pulse of 115 (normally it's 66). Around noon I went back to the pharmacy to ask whether an elevated heart rate was a known side effect. The pharmacist verified my HR and sent me home warning me to look out for symptoms of a stroke. I decided instead to go to Urgent Care where they verified my tachycardia, took an Xray to check my lungs (they were normal) and an EKG (also normal). They sent me home warning me to look out for symptoms of a stroke. I woke up the next morning with a normal heart rate and almost inaudible tinnitus  (normal for me). Three days after the tachycardia I was examined by a physician whose comment was "thank goodness this was your second vaccination, not your first." She then entered Shingrix in my medical record as an allergy.
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Blood magnesium, Blood urea, Chills, Electroencephalogram, Full blood count
Clinical narrative: on the evening of 1/10/2020, patient had (10) episodes of shuttering/shivering. Happened even during play. No LOC. Episodes last for seconds - Does not turn blue. Seen in the ER locally on 1-11-20 and sent to ER for evaluation and admission
Age: 0.42
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: Liver function test, Metabolic function test, Urine analysis
Clinical narrative: on the evening of 1/10/2020, patient had (10) episodes of shuttering/shivering. Happened even during play. No LOC. Episodes last for seconds - Does not turn blue. Seen in the ER locally on 1-11-20 and sent to ER for evaluation and admission
Age: 1.25
Sex: F
Vaccine: DTAP, HEPA, HIBV, PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: red swollen knot on (L) thigh
Age: 20.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Chest X-ray, Chest pain, Differential white blood cell count, Dizziness, Dyspnoea
Clinical narrative: Chest pain, shortness of breath; Dizziness
Age: 20.0
Sex: F
Vaccine: HPV4, MENB
Symptoms: Electrocardiogram, Full blood count, Glomerular filtration rate, Metabolic function test, Urine analysis
Clinical narrative: Chest pain, shortness of breath; Dizziness
Age: 75.0
Sex: F
Vaccine: FLUA3
Symptoms: Hypoaesthesia oral, Lip swelling, Paraesthesia oral
Clinical narrative: Patient reported that she experienced swelling of the lower lip along with slight numbing and tingling sensation in that area after receiving the influenza vaccine on 8/25/20. Patient reported that symptoms started around 7:00pm on 8/25/20. Patient states that she did not receive any treatment or take any medications to mitigate adverse reaction. Patient presented to pharmacy on 8/26/20, I observed slight swelling of lower lip. Patient reported that she was not having any trouble breathing or tightness of chest. Patient was advised to take Benadryl OTC and contact her PCP.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Immediate post-injection reaction, Injection site pain, Injection site swelling, Pain
Clinical narrative: Patient called the pharmacy on 8/26/20 and stated that she had a reaction to the Shingrix vaccine that she received. She stated that she immediately felt pain and discomfort and that she complained to the pharmacist at that time. Patient is reporting that she developed a rash on her left side, near her breast that evening and she is experiencing pain and swelling around the injection site and in the right arm. She went to her physician and was prescribed lidocaine 5% patch to help with the pain.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Patient called the pharmacy on 8/26/20 and stated that she had a reaction to the Shingrix vaccine that she received. She stated that she immediately felt pain and discomfort and that she complained to the pharmacist at that time. Patient is reporting that she developed a rash on her left side, near her breast that evening and she is experiencing pain and swelling around the injection site and in the right arm. She went to her physician and was prescribed lidocaine 5% patch to help with the pain.
Sex: M
Vaccine: DTAP
Symptoms: Pallor, Peripheral swelling, Rash, Rash maculo-papular
Clinical narrative: Today mom noticed swelling of hands, feet, blanching maculopapular rash on trunk
Age: 74.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Chills, Feeling abnormal, Injection site erythema, Pain, Pyrexia
Clinical narrative: states redness at site, chills, slight fever, soreness, felt awful
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Dizziness, Limb discomfort, Malaise, Musculoskeletal discomfort, Nausea
Clinical narrative: Patient noticed later in the day after receiving the vaccine feeling dizzy, nauseous, and overall not well. Their arm was sore and swollen. The following day the swelling was evident and the discomfort was in the neck and arm. The swelling traveled to the elbow area. The patient was advised to contact their provider about the adverse reaction and to take Benadryl and ice the area to subside the reaction. The patient stated Benadryl also made her nauseous. The patient waited a few days and the reaction, soreness, and ill feelings subsided some. There was still some swelling. The patient finally contacted the doctor by day 7.
Age: 79.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient noticed later in the day after receiving the vaccine feeling dizzy, nauseous, and overall not well. Their arm was sore and swollen. The following day the swelling was evident and the discomfort was in the neck and arm. The swelling traveled to the elbow area. The patient was advised to contact their provider about the adverse reaction and to take Benadryl and ice the area to subside the reaction. The patient stated Benadryl also made her nauseous. The patient waited a few days and the reaction, soreness, and ill feelings subsided some. There was still some swelling. The patient finally contacted the doctor by day 7.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Pain in extremity, Rash erythematous, Urticaria
Clinical narrative: *Immunized arm is still sore, with red welts and pt. is very fatigued *Told patient to try cortisone, Benadryl and ice.
Age: 18.0
Sex: F
Vaccine: HPV9, MNQ, UNK
Symptoms: Abnormal behaviour, Amnesia
Clinical narrative: memory loss; Patient was out of it; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (VAERS ID:818356) referring to an 18 year old non-pregnant female patient. The patient's chronic or long-standing health conditions included penicillin and sulfonamide allergy, generalised anxiety disorder and pulmonary artery stenosis congenital. At the time of vaccination, the patient had no illness and had not ever had an adverse event following any previous vaccine.  There were no prescriptions, over-the-counter medications, dietary supplements or herbal remedies being taken.  On 05-JUN-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) prefilled syringe, 1st dose in series, in the left arm, intramuscularly, for prophylaxis (lot # 1602283, expiring date not provided but upon internal validation established as 18-AUG-2021).    Other suspect vaccines administered on the same date included meningococcal acyw conj vaccine (crm197) (MENVEO) 3rd dose in series, in the right arm, intramuscularly, for prophylaxis (lot # AMVA093A) and an unspecified vaccine, intradermal, in the left arm, dose 1 in serie, lot # C5482AB.      On 06-JUN-2019, the patient's mom called and stated the patient was acting like she was 'high', but she did not take other drugs, and was saying weird things (abnormal behaviour). She stated the patient did not remember the last two days (amnesia). Mom and patient went into the office to have her ppd test read, and talked with reporting registered nurse (also reported as "required doctor office visit").  None medical test/laboratory results were provided.  The patient was feeling somewhat better.  At the time of reporting, the patient had recovered from the events.  The agency considered this case as non-serious.  The reporter did not assess the causal relationship between suspect therapies and the patient's events.  Follow up information has been received on 21-AUG-2020 from the Nurse.  On 05-JUN-2020, the patient experienced an abnormal behavior, reported as "out of it". She also had memory loss on the same date. On 07-JUN-2020, she had recovered from the events.   The reporter considered abnormal behavior and memory impairment to be serious due to medically significant. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp. ; devicelotnumber: 1602283; expirationdate: 18-AUG-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Unknown; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Sex: F
Vaccine: FLUR4, FLUR4
Symptoms: Dizziness, Headache, Heart rate increased, Hypotension, Injection site bruising
Clinical narrative: light headed, dizzy; Tachycardia; hard welt; hypotensive; swelling in the arm-left arm 2 inches by 1 inch; swelling in the arm-left arm 2 inches by 1 inch; Initial information received on 18-Aug-2020 regarding an unsolicited valid non-serious case received from a consumer.  This case involves female of an unknown age patient who experienced light headed, dizzy (dizziness), tachycardia, hard welt (urticaria), hypotensive (hypotension), swelling in the arm-left arm 2 inches by 1 inch (swelling) and (vaccination site reaction), while she received vaccine INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV].  Medical history, medical treatment( and family history were not provided.  At the time of the event, the patient had ongoing Food allergy.  Patient was received the Seqirus vaccine in the past without a reaction.  On 14-Aug-2020, the patient received a dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE (lot number and expiry date: not reported) via an unknown route at an unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious light headed, dizzy (dizziness), tachycardia, hard welt (urticaria), hypotensive (hypotension), swelling in the arm-left arm 2 inches by 1 inch (swelling) and (vaccination site reaction), (unknown latency) following the administration of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE.  It was reported that patient received a Flu shot vaccine on Friday 14Aug2020.  When she got home patient noticed her vaccine paperwork stated Seqirus, with an expiration date of May2020, patient was then told she received Flublok. The only information she had was the top of the syringe was navy and gray with the number B0170.    Relevant laboratory test results included: Blood pressure measurement - On an unknown date:  [not reported]  Details of laboratory data not reported.   The patient was treated arm with ice DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]). Continued use of ice and Benadryl.  On an unknown date, the patient recovering from the all events.  There will be no information available on the batch number for this case.